Biomedical Knowledge Data Package
This package has 20 modules. The Clinical Trials Module has 16 tables. Preview the first five rows of each table or Explore the schema
Clinical Trials Module
16 Tables
Provides detailed information about clinical trials including interventions, trial arms, location, sponsor, trial conditions and more. Information is normalized, linked, and many relevant metadata descriptions are structured and ready for analysis.
id | trial_id | kind | label | description |
---|---|---|---|---|
000007f1-99e4-4ae6-9cef-c364e92d16fb | NCT03834610 | active_comparator | Group B | receive tadalafil 10 mg oral tablets daily for 8 weeks serum testosterone level
measurement penile doppler |
00001dda-40b7-4499-871b-22616809a01c | NCT04911894 | experimental | Phase Ia Dose-Escalation Stage: IBI321 | |
000087f4-4b80-4336-86f8-78e1a1cdb983 | NCT00324961 | experimental | Single arm open label adefovir dipivoxil | adefovir dipivoxil once daily 10 mg orally |
0000afe0-25e9-4e20-8282-1ade60a8ff08 | NCT04090736 | experimental | Arm A: Pevonedistat plus Azacitidine | Pevonedistat 20 mg/m2 IV on days 1, 3, and 5 plus Azacitidine 75 mg/m2 subcutaneous
administered on a 5-on/2-off [weekend]/2-on schedule in 28-day cycles (intravenous
Azacitidine can be administered for any patients who have non-tolerated local reactions) |
0000eaf0-b48f-4856-80c1-d792bfff7b70 | NCT06409299 | placebo_comparator | Placebo Oral suspension |
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id | trial_id | title | condition_id |
---|---|---|---|
0 | NCT00000726 | Cytomegalovirus Retinitis | 283 |
1 | NCT00000726 | Retinitis | 9843 |
2 | NCT00000333 | Cocaine-Related Disorders | 37604 |
3 | NCT00000621 | Emphysema | 19688 |
4 | NCT00000621 | Pulmonary Emphysema | 4300 |
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id | trial_id | title | drug_id |
---|---|---|---|
0 | NCT00000726 | Foscarnet | 529 |
1 | NCT00000726 | Phosphonoacetic Acid | 2823 |
2 | NCT00000179 | Trazodone | 656 |
3 | NCT00000179 | Haloperidol decanoate | 502 |
4 | NCT00000179 | Haloperidol | 502 |
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trial_id | condition_id |
---|---|
NCT06207370 | 21 |
NCT00415051 | 45 |
NCT00584194 | 45 |
NCT00869713 | 45 |
NCT03609398 | 45 |
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trial_id | country |
---|---|
NCT00000102 | United States |
NCT00000105 | United States |
NCT00000110 | United States |
NCT00000116 | United States |
NCT00000117 | United States |
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id | trial_id | sampling_method | gender | gender_based | gender_description | min_age | max_age | healthy_volunteers | criteria | population |
---|---|---|---|---|---|---|---|---|---|---|
000032d4-fe13-4112-beb1-f256ac218516 | NCT02239380 | All | 0 | 3 Months | No | Inclusion Criteria:
- Subjects with status epilepticus or repetitive status epilepticus / cluster seizure
who have seizures that can be evaluated by investigator's visual observations based
on motor symptoms or who have seizures that can be evaluated by EEG.
- Subjects with status epilepticus accompanied by generalized seizure, partial seizure
or secondarily generalized seizure lasting 5 minutes or longer
- Subjects with repetitive status epilepticus / cluster seizure accompanied by not
less than 3 consecutive episodes of generalized seizure, partial seizure or
secondarily generalized seizure in 1 hour.
- Subjects not younger than 3 months (either gender is eligible for the study)
Exclusion Criteria:
- Subjects with known or suspected recurrent seizures due to illegal drug or alcohol
withdrawal
- Subjects with known history of hypersensitivity to lorazepam or benzodiazepine
- Subjects with a known history of benzodiazepine abuse.
- Subjects currently receiving lorazepam
- Subjects with angle-closure glaucoma
- Subjects with myasthenia gravis
- Subjects with either of aspartate transaminase, alanine transaminase, total
bilirubin, blood urea nitrogen, or creatinine at screening visit exceeding 2x the
upper limit of normal of the institutional reference value (if the data is
available)
- Subjects with white blood cell count less than 3000/mm3 or neutrophil count less
than 1500/mm3 at screening visit (if the data is available) | ||||
0000c2ab-2fd4-478b-bd36-5a743622e466 | NCT00589485 | Non-Probability Sample | All | 0 | 18 Years | No | Inclusion Criteria:
- Patients with painful and disabled knee joint resulting from osteoarthritis,
rheumatoid arthritis, traumatic arthritis where one or more compartments are
involved
- Patients requiring correction of varus, valgus, or posttraumatic deformity
- Patients requiring correction or revision of unsuccessful osteotomy, arthrodesis, or
failure of previous joint replacement procedure
Exclusion Criteria:
- Infection, sepsis, and osteomyelitis | The study population will include patients who require total knee replacement. | ||
0001264a-1354-4946-868a-7838224dd14b | NCT02060383 | All | 0 | 18 Years | No | Inclusion Criteria:
- Patients greater than or equal to 18 years old
- Confirmed diagnosis of Cushing's disease or acromegaly
Exclusion Criteria:
- Patients who require surgical intervention
- Patients receiving DPP-4 inhibitors or GLP-1 receptor agonists within 4 weeks prior
to study entry
- HbA1c > 10 % at screening
- Known hypersensitivity to somatostatin analogues Other protocol-defined
inclusion/exclusion criteria may apply. | ||||
00013c19-631c-43f0-a80c-3e1876c4ce0f | NCT00505518 | All | 0 | 18 Years | No | Inclusion Criteria:
- Clinical diagnosis of Major Depressive Disorder
- Patient at South Cove Manor Nursing Home
- Referred by nursing staff for psychiatric consultation
Exclusion Criteria:
- Not competent to participate in psychiatric interviews | ||||
00014719-3aca-4ca3-bd08-2e163777c3cf | NCT01742767 | All | 0 | 18 Years | 75 Years | No | Inclusion Criteria:
- Patients are eligible to be included in the study only if they meet all of the
following criteria:
1. Histologically or cytologically confirmed diagnosis of non-squamous-cell
non-small cell lung cancer (NSCLC) Stage IV (American Joint Committee on Cancer
Staging Criteria [AJCC], Version 7, 2009)
2. No prior systemic chemotherapy for lung cancer
3. At least one unidimensionally measurable lesion meeting Response Evaluation
Criteria in Solid Tumours (RECIST; version 1.1, Eisenhauer et al. 2009),
longest diameter ≥10 mm with computed tomography (CT) scan [CT scan slice
thickness no greater than 5 mm] , or ≥ 20 mm with chest x-ray. Positron
emission tomography (PET) scans and ultrasounds should not be used.
4. ECOG performance status of 0 or 1 (Oken et al. 1982)
5. ≥ 18 years of age < 75 years
6. Adequate organ function,
7. Prior radiation therapy allowed to <25% of the bone marrow (Cristy and Eckerman
1987). Prior radiation to the whole pelvis is not allowed. Prior radiotherapy
must be completed at least 4 weeks before study enrollment. Patients must have
recovered from the acute toxic effects of the treatment prior to study
enrollment.
8. Patient must understand and sign an informed consent document before the start
of specific protocol procedures.
9. A pretreatment FFPE tumour biopsy must be available for central biomarker
analysis. If consented by the patient and clinically feasible, a fresh
pretreatment biopsy is obtained and submitted for central biomarker analysis.
10. Female patients with childbearing potential must use highly effective methods
of contraception (combined oral contraceptives, hormon-releasing intrauterine
contraceptive device, hormonal contraceptive implants, hormonal contraceptive
injectables) or have sexual intercourse with a vasectomised partner only during
and for 6 months after the study and their pregnancy test must be negative
within 7 days prior to study enrollment.
A female subject is considered to be of childbearing potential unless she is
age ≥ 50 years and naturally amenorrhoeic for ≥ 2 year or unless she is
surgically sterile.
Male patients must agree to use condoms during the study and for 6 months after
the study if their partner is of childbearing potential and does not use highly
effective method of contraception.
11. Estimated life expectancy of 12 weeks
12. Patient compliance and geographic proximity that allow adequate follow up.
Exclusion Criteria:
- Patients will be excluded from the study if they meet any of the following criteria:
1. Active participation in other clinical studies or treatment with any
experimental drug within 30 days prior to study enrollment or during study
participation.
2. Patients with known somatic activating mutations of EGFR, as these patients
should be offered EGFR- tyrosine kinase inhibitor (EGFR-TKI) treatment as
first-line therapy. Detection of EGFR mutations and additional somatic
mutations with relation to treatment will be performed centrally at the
Universitätsklinikum Essen. In case immediate treatment initiation is required
for medical reasons (such as superior vena cava syndrome, severely symptomatic
disease) patients may be enrolled before results from EGFR testing are
available. As EGFR-TKI treatment is equally effective in second-line therapy,
such patients may remain on study treatment if a clinical benefit is derived.
3. Peripheral neuropathy of ³CTCAE Grade 1
4. Inability to comply with protocol or study procedures
5. A serious concomitant systemic disorder that, in the opinion of the
investigator, would compromise the patient's ability to complete the study.
6. A serious cardiac condition, such as myocardial infarction within 6 months
prior to study enrollment, symptomatic coronary artery disease, cardiac
arrhythmia, or other heart disease, as defined by the New York Heart
Association Class III or IV (functional capacity)
7. Second primary malignancy that is clinically detectable at the time of
consideration for study enrollment
8. Documented brain metastases unless the patient has completed successful local
therapy for central nervous system metastases and has been off of
corticosteroids for at least 4 weeks before enrollment. Brain imaging is
required in symptomatic patients to rule out brain metastases,but is not
required in asymptomatic patients
9. The effect of third space fluid, such as pleural effusion and ascites, on
pemetrexed is unknown. In patients with clinically significant third space
fluid, consideration should be given to draining the effusion prior to
pemetrexed administration.
10. Significant weight loss (that is 10%) over the previous 6 weeks before study
entry
11. Significant hearing function impairment, especially high-frequency hearing
function impairment
12. Any active or uncontrolled infection
13. Concurrent administration of any other antitumour therapy
14. Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents,
other than an aspirin dose <1.3 grams per day, for a 5-day period (8-day period
for long-acting agents, such as piroxicam)
15. Inability or unwillingness to take folic acid or vitamin B12 supplementation
16. Inability to take corticosteroids
17. Hypersensitivity to cisplatinum or to any other platinum compound
18. Hypersensitivity to pemetrexed or to any of the excipients of ALIMTA®
19. Pregnant or breast-feeding patient
20. Yellow fever vaccination within the 30 days previous to study entry. |
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id | trial_id | identifier | kind |
---|---|---|---|
0 | NCT00000726 | NCT00000726 | primary |
1 | NCT00000726 | ACTG 015 | org_study_id |
2 | NCT00000726 | FDA 20D | external |
3 | NCT00000726 | 10991 | external |
4 | NCT00001302 | NCT00001302 | primary |
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intervention_id | arm_group_id |
---|---|
00003369-7f9d-4f3d-a5f3-8791add7ae73 | 75f6ae02-19ef-40a8-a704-f21a0f22782d |
00003369-7f9d-4f3d-a5f3-8791add7ae73 | c87b54dd-5857-4b63-abcb-c020d2b3d70a |
00007119-bd3b-4baf-bfa2-2b8b72b0fbdc | 99e58ce0-36fa-4716-96a3-bef08c6a6218 |
000087cb-d10e-429b-852b-a92a49bfc968 | a0d6859d-79b5-4255-ac5f-b2d3b2631d35 |
000087cb-d10e-429b-852b-a92a49bfc968 | a2e5d7c9-bddd-474b-a379-a5d1f7d9c21b |
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id | trial_id | kind | title | description |
---|---|---|---|---|
00003369-7f9d-4f3d-a5f3-8791add7ae73 | NCT02696954 | drug | Amodiaquine | Amodiaquine on Day 0, 1 and 2 Washout period: more than 6 weeks |
00007119-bd3b-4baf-bfa2-2b8b72b0fbdc | NCT06975865 | drug | Rilzabrutinib | Pharmaceutical form:Tablet -Route of administration:Oral |
000087cb-d10e-429b-852b-a92a49bfc968 | NCT05944952 | drug | buprenorphine/naloxone | Participants will be dosed with buprenorphine/ naloxone strips |
0000c179-971f-4b87-a009-fa35502ebc96 | NCT02161965 | drug | Warfarin | |
00010ba2-52e9-4928-966a-0b004d65e13e | NCT04605562 | drug | Galunisertib | Administered orally |
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id | intervention_id | drug_id |
---|---|---|
204862 | 00003369-7f9d-4f3d-a5f3-8791add7ae73 | 613 |
375157 | 00007119-bd3b-4baf-bfa2-2b8b72b0fbdc | 28133 |
342379 | 000087cb-d10e-429b-852b-a92a49bfc968 | 921 |
342378 | 000087cb-d10e-429b-852b-a92a49bfc968 | 1183 |
174452 | 0000c179-971f-4b87-a009-fa35502ebc96 | 682 |
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id | intervention_id | name |
---|---|---|
0 | bf6f2649-31e2-4aee-b552-4bffe191f3b0 | Elavil |
1 | f096be51-752d-4b08-829b-c90c16c00055 | elavil plus prozac |
2 | 95966692-f845-48e2-91ed-00b8e889ca85 | Subutex |
3 | 95966692-f845-48e2-91ed-00b8e889ca85 | Suboxone |
4 | c07a15aa-8ddb-4fa3-9015-76bde5cff910 | Zoloft |
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id | intervention_id | product_id |
---|---|---|
98127 | 000087cb-d10e-429b-852b-a92a49bfc968 | 157804 |
81453 | 00012692-6234-4c30-a7c1-cb1fde38bd99 | 489254 |
95794 | 0001d859-a82c-4a33-8072-0f4a7e4ba452 | 139536 |
72375 | 00046298-3c8b-432d-b463-62fb15cf588c | 317307 |
72374 | 00046298-3c8b-432d-b463-62fb15cf588c | 430009 |
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trial_id | phase |
---|---|
NCT00017381 | 0 |
NCT00020670 | 0 |
NCT00091286 | 0 |
NCT00140556 | 0 |
NCT00176059 | 0 |
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id | trial_id | company_id | title | normalized_title | agency_class | lead_sponsor |
---|---|---|---|---|---|---|
0 | NCT00000726 | National Institute of Allergy and Infectious Diseases (NIAID) | National Institute of Allergy & Infectious Diseases Niaid | nih | 1 | |
1 | NCT00001302 | National Cancer Institute (NCI) | National Cancer Institute Nci | nih | 1 | |
2 | NCT00000179 | National Institute on Aging (NIA) | National Institute on Aging Nia | nih | 1 | |
3 | NCT00000333 | Washington D.C. Veterans Affairs Medical Center | Washington Dc Veterans Affairs Medical Center | us_fed | 0 | |
4 | NCT00000333 | National Institute on Drug Abuse (NIDA) | National Institute on Drug Abuse Nida | nih | 1 |
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identifier | title | official_title | status | purpose | acronym | summary | description | expanded_access | why_stopped | why_stopped_category_id | start_date | end_date | end_date_kind | plus_export |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
NCT00000102 | Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets | completed | treatment | This study will test the ability of extended release nifedipine (Procardia XL), a blood
pressure medication, to permit a decrease in the dose of glucocorticoid medication
children take to treat congenital adrenal hyperplasia (CAH). | This protocol is designed to assess both acute and chronic effects of the calcium channel
antagonist, nifedipine, on the hypothalamic-pituitary-adrenal axis in patients with
congenital adrenal hyperplasia. The multicenter trial is composed of two phases and will
involve a double-blind, placebo-controlled parallel design. The goal of Phase I is to
examine the ability of nifedipine vs. placebo to decrease adrenocorticotropic hormone
(ACTH) levels, as well as to begin to assess the dose-dependency of nifedipine effects.
The goal of Phase II is to evaluate the long-term effects of nifedipine; that is, can
attenuation of ACTH release by nifedipine permit a decrease in the dosage of
glucocorticoid needed to suppress the HPA axis? Such a decrease would, in turn, reduce
the deleterious effects of glucocorticoid treatment in CAH. | 0 | 0 | |||||||
NCT00000105 | Vaccination With Tetanus and KLH to Assess Immune Responses. | Vaccination With Tetanus Toxoid and Keyhole Limpet Hemocyanin (KLH) to Assess Antigen-Specific Immune Responses | terminated | The purpose of this study is to learn how the immune system works in response to
vaccines. We will give the vaccines to subjects who have cancer but have not had
treatment, and to patients who have had chemotherapy or stem cell transplant. Some
patients will get vaccines while they are on treatments which boost the immune system
(like the immune stimulating drug interleukin-2 or IL-2). Although we have safely treated
many patients with immune boosting drugs, we do not yet know if they improve the body's
immune system to respond better to a vaccine. Some healthy volunteers will also be given
the vaccines in order to serve as control subjects to get a good measure of the normal
immune response. We will compare the patients and the healthy volunteers to study how
their immune systems respond to the vaccines.
There are several different types of white cells in the blood. We are interested in
immune cells in the blood called T-cells. These T-cells detect foreign substances in the
body (like viruses and cancer cells). We are trying to learn more about how the body
fights these foreign substances. Our goal is to develop cancer vaccines which would teach
T-cells to detect and kill cancer cells better. We know that in healthy people the immune
system effectively protects against recurrent virus infection. For example, that is why
people only get "mono" (mononucleosis) once under normal circumstances. When the body is
infected with the "mono" virus, the immune system remembers and prevents further
infection. We are trying to use the immune system to prevent cancer relapse. To test
this, we will give two vaccines which have been used to measure these immune responses.
Blood samples will be studied from cancer patients and will be compared to similar
samples from normal subjects. | Patients will receive each vaccine once only consisting of:
Arm A: Intracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoid 0.5 ml
intramuscularly (this arm closed 1/2/02).
Arm B: Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml
intramuscularly (this arm closed 3/18/03).
Arm C: Biosyn KLH 1000 mcg (1 mg) with Montanide ISA51 (now replaced with vegetable (VG)
source after 8/31/06 to increase product safety) subcutaneous Tetanus toxoid 0.5 ml
intramuscularly (this arm open 3/18/03).
Subjects ineligible for tetanus may still receive KLH on this protocol. This is
especially true given the national shortage of tetanus vaccines. Subjects will be
eligible for tetanus when it becomes available if there has been no significant change in
treatment interventions or overall health status and it is within 3 months of the KLH
vaccine. | 0 | Replaced by another study. | 136 | 2002-07-01 | 2012-03-01 | actual | 0 | ||
NCT00000110 | Influence of Diet and Endurance Running on Intramuscular Lipids Measured at 4.1 TESLA | completed | treatment | The purpose of this pilot investigation is to use 1 H Magnetic Resonance Spectroscopy
(MRS) to 1) document the change in intra-muscular lipid stores (IML) before and after a
prolonged bout of endurance running and, 2) determine the pattern (time course) of IML
replenishment following an extremely low-fat diet (10% of energy from fat) and a
moderate-fat diet (35% of energy from fat). Specifically, the study will evaluate the
change in IML following a 2-hour training run and the recovery of IML in response to the
post-exercise low-fat or moderate-fat diet in 10 endurance trained athletes who will
consume both diets in a randomly assigned cross-over fashion. We hypothesize that IML
will be depleted with prolonged endurance exercise, and that replenishment of IML will be
impaired by an extremely low-fat diet compared to a moderate-fat diet. Results of this
pilot study will be used to apply for extramural grant support from NIH or the US Armed
Forces to investigate the effect of dietary fat on the health and performance of
individuals performing heavy physical training. It is anticipated that this methodology
could also be employed in obesity research to delineate, longitudinally, the reported
cross-sectional relationships among IML stores, insulin resistance and obesity. | 0 | 1 | ||||||||
NCT00000114 | Randomized Trial of Vitamin A and Vitamin E Supplementation for Retinitis Pigmentosa | completed | treatment | To determine whether supplements of vitamin A or vitamin E alone or in combination affect
the course of retinitis pigmentosa. | Retinitis pigmentosa (RP) is a group of inherited retinal degenerations with a worldwide
prevalence of about 1 in 4,000. Patients typically report night blindness in adolescence
and lose vision in the midperipheral followed by far-peripheral visual field in adulthood
due to progressive loss of both rod and cone function. Most patients have reductions in
central vision by age 50 to 80 years. Modern-day electroretinograms (ERGs) make it
possible to record retinal responses from most patients with remaining vision and thereby
monitor objectively the course of their disease.
While the natural course of retinal degeneration in the common forms of RP was being
studied, it was noted that a subgroup of patients aged 18 through 49 who were treating
themselves with both vitamin A and vitamin E and other nutritional supplements exhibited
less decline in ERG amplitude over a 2-year period. These preliminary findings, as well
as the known roles of vitamins A and E in maintaining normal photoreceptor function and
structure, prompted this randomized, controlled trial to determine whether these vitamins
alone or in combination would halt or slow the progression of the common forms of RP.
This study was a randomized, controlled double-masked trial with 2 x 2 factorial design
and duration of 4 to 6 years. Patients were assigned to one of four treatment groups:
15,000 IU/day vitamin A
15,000 IU/day vitamin A + 400 IU/day vitamin E
trace amounts of both vitamins A and E
400 IU/day of vitamin E
The main outcome measure was the 30-Hz cone ERG amplitude. In addition, visual field and
visual acuity were measured annually. | 0 | 1984-05-01 | 1987-06-01 | actual | 0 | ||||
NCT00000115 | Randomized Trial of Acetazolamide for Uveitis-Associated Cystoid Macular Edema | completed | treatment | To test the efficacy of acetazolamide for the treatment of uveitis-associated cystoid
macular edema. | Uveitis, an intraocular inflammatory disease, is the cause of about 10 percent of visual
impairment in the United States. Uveitis may lead to many sight-threatening conditions,
including cataract, vitreal opacities, glaucoma, and, most commonly, cystoid macular
edema. Reduction of swelling or edema within the retina depends on the movement of fluid
from the retina through the choroid. A number of studies indicate that this process
requires active transport of fluid ions by the retinal pigment epithelium and may involve
the carbonic anhydrase system. Current treatment of uveitis-associated cystoid macular
edema requires the use of immunosuppressive or anti-inflammatory agents. However, many
patients are either resistant or intolerant to this therapy. Recent reports suggested
that acetazolamide, a carbonic anhydrase inhibitor that is used to lower intraocular
pressure in some glaucoma patients, might be safe and effective in reducing
uveitis-associated cystoid macular edema.
Because the course of ocular inflammatory disease can be variable, a double-masked,
randomized, crossover trial was designed to test the efficacy of acetazolamide compared
with a placebo for the treatment of uveitis-associated cystoid macular edema. Randomized
adult patients received either oral acetazolamide sodium 500 mg or a matched placebo
every 12 hours for the first 4 weeks of the study. Children 8 years of age or older
received a lesser dose based on body weight. Following a 4-week period, during which no
medication was given, patients then received a 4-week course of the opposite medication.
Primary end points included reduction in cystoid macular edema (graded on fluorescein
angiography) and improvement in visual acuity (measured on standardized Early Treatment
Diabetic Retinopathy Study [ETDRS] charts). Laser acuity was also assessed as a secondary
outcome variable. Adverse effects of the acetazolamide therapy were monitored by clinical
and laboratory examinations.
A total of 40 patients were recruited for the study. Patients were seen at the beginning
of the study for baseline measurements and at 4, 8, and 12 weeks after enrollment into
the study. | 0 | 1990-12-01 | 1994-06-01 | actual | 0 |
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id | category | definition | safety_efficacy_concern |
---|---|---|---|
1 | Business Decision | The trial was terminated due to a strategic or administrative decision by the sponsor company. | 0 |
6 | Change in Medical/Clinical Practices | The study drug was deemed no longer suitable for the target indication due to changes in medical or clinical practices. | 0 |
11 | Competing Studies | The study drug is being investigated in other competing trial(s), and continuing this trial was deemed futile. | 0 |
16 | Completed | The trial was successfully completed (user input was incorrectly marked as terminated). | 0 |
21 | Conflict of Interest | The parties involved had conflicts of interests. | 0 |
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Showing 16 of 16 tables