ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00798707
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Sponsor: Pfizer
Start date: 2008-12-01; Completion date: 2010-04-01
Enrollment: 709 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to compare the antidepressant efficacy and safety of two doses of DVS SR (25 and 50 mg/day) in the treatment of adults with Major Depressive Disorder. The study will also assess changes in sexual function and general and functional quality of life outcomes.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Desvenlafaxine Succinate Sustained-Release (DVS SR) intervention 2: Desvenlafaxine Succinate Sustained-Release (DVS SR) intervention 3: placebo
Intervention descriptions: intervention 1: 25 mg tablet, once daily dosing for 8 weeks intervention 2: 50 mg tablet, once daily dosing for 8 weeks intervention 3: Matching placebo tablets (25 or 50 mg). Daily dosing for 10 +/- 4 days during a placebo lead-in period, and then 8 weeks during the double-blind period.

Protocol documents:
Clinical trial NCT00811395
Conditions: Multiple Sclerosis
Sponsor: Sanofi
Start date: 2007-10-01; Completion date: 2010-04-01
Enrollment: 182 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective was to evaluate the long-term safety and tolerability of teriflunomide when added to treatment with interferon-β \[IFN-β\] or glatiramer Acetate \[GA\] in patients with multiple sclerosis \[MS\] with relapses.

Secondary objectives were to evaluate the long-term effect on relapse rate, disability progression and Magnetic Resonance Imaging \[MRI\] parameters.

This study is the extension study of the PDY6045 (NCT00489489) and PDY6046 (NCT00475865) studies. Participants who successfully completed the initial study were offered to continue their treatment (same compound, same dose) for 24 additional weeks.

Detailed description:
The duration of the extension study per participants was 40 weeks broken down as follows:

* 24-week double-blind treatment period,
* 16-week post-treatment elimination follow-up period.

Arms: arm 1: Placebo (for teriflunomide) once daily concomitantly with interferon-β \[IFN-β\] for 24 additional weeks arm 2: Teriflunomide 7 mg once daily concomitantly with interferon-β \[IFN-β\] for 24 additional weeks arm 3: Teriflunomide 14 mg once daily concomitantly with interferon-β \[IFN-β\] for 24 additional weeks arm 4: Placebo (for teriflunomide) once daily concomitantly with glatiramer acetate \[GA\] for 24 additional weeks arm 5: Teriflunomide 7 mg once daily concomitantly with glatiramer acetate \[GA\] for 24 additional weeks arm 6: Teriflunomide 14 mg once daily concomitantly with glatiramer acetate \[GA\] for 24 additional weeks
Interventions: intervention 1: Teriflunomide intervention 2: Placebo (for teriflunomide) intervention 3: Interferon-β [IFN-β] intervention 4: Glatiramer Acetate [GA]
Intervention descriptions: intervention 1: Film-coated tablet

Oral administration intervention 2: Film-coated tablet

Oral administration intervention 3: Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection intervention 4: Solution in prefilled syringe for subcutaneous injection

Protocol documents:
Clinical trial NCT00822354
Conditions: Raynaud
Keywords: Secondary Raynaud's Phenomenon
Sponsor: Northwestern University
Start date: 2008-09-01; Completion date: 2010-04-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The investigators propose that tadalafil will increase digital blood flow and improve the symptoms and signs of secondary Raynaud's phenomenon.

Detailed description:
The primary goal of our study is to decrease the frequency, duration and severity of vasospastic attacks in patients with secondary Raynaud's. The secondary goal is to document increased blood flow and lessened capillary dysfunction in these patients. Both of these goals are to be achieved using a course of treatment with Tadalafil.We anticipate a decrease in the frequency, duration and severity of Raynaud's attacks. Improved digital blood flow and digital blood pressures, and a decrease in digital capillary dysfunction.

Arms: arm 1: Subjects will receive tadalafil 20mg every other day for the first month, and then placebo for the second month. arm 2: Subjects will receive placebo for the first month, and tadalafil 20mg orally every other day for the second month.
Interventions: intervention 1: Tadalafil
Intervention descriptions: intervention 1: Subjects will be randomized to receive either tadalafil for the first month followed by placebo or placebo for the first month and followed by tadalafil

Protocol documents:
Clinical trial NCT00827918
Conditions: Schizophrenia
Keywords: Acute Exacerbation of Schizophrenia
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-03-01; Completion date: 2010-04-01
Enrollment: 216 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to evaluate the safety and efficacy of treatment with MK-8998 as compared to placebo and olanzapine for acutely psychotic patients with schizophrenia. The primary hypothesis is that in participants undergoing an acute psychotic episode of schizophrenia, MK-8998 6 to 8 mg twice daily is superior to placebo in the treatment of symptoms of schizophrenia as measured by the mean change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 4.

Detailed description:

Arms: arm 1: MK-8998, 6 mg twice a day (BID) for Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period arm 2: Olanzapine, 5 mg BID for Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period arm 3: Placebo Comparator to MK-8998 or olanzapine
Interventions: intervention 1: MK-8998 intervention 2: Comparator: Olanzapine intervention 3: Comparator: Placebo
Intervention descriptions: intervention 1: MK-8998 6 mg capsules twice daily with food on Days 1 through 7. On Day 8, dosage will be increased to 8 mg capsules twice daily. Treatment period is 4 weeks. There will be a period of time when all participants will receive placebo. intervention 2: Olanzapine 5 mg tablets twice daily with food on Days 1 through 7. On Day 8, dosage will be increased to 5 mg tablets in the morning and 10 mg tablets in the evening. Treatment period is 4 weeks. There will be a period of time when all participants will receive placebo. intervention 3: Placebo tablets matching olanzapine tablets and MK-8998 capsules

Protocol documents:
Clinical trial NCT00837252
Conditions: Retinal Disease
Keywords: Central Serous Chorioretinopathy Finasteride Proscar Retinal Eye Disease
Sponsor: National Eye Institute (NEI)
Start date: 2009-02-01; Completion date: 2010-04-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Central serous chorioretinopathy (CSC) is a retinal disorder characterized by an accumulation of serous fluid under the retina. Although acute CSC tends to spontaneously resolve on its own with minimal sequelae, chronic CSC tends to persist and lead to irreversible visual loss. The pathogenesis of CSC is complex; however, systemic androgens have been implicated. Finasteride is an anti-androgen medication that is widely used in the treatment of various conditions. The objective of this study was to investigate the safety and potential efficacy of oral finasteride as a treatment for chronic CSC.

Five participants with chronic CSC were enrolled into this uncontrolled, unmasked, Phase I/II study. An oral dose of finasteride, 5 mg daily, was administered to all participants for three months.

Following this, finasteride was withheld and participants were observed for another three months. If a participant experienced a beneficial effect during the period in which he received finasteride and then experienced a relapse during the observation period, finasteride was re-instituted for the remaining period of the study. Relapse was defined as a return to the baseline maximum lesion height and/or return to baseline lesion volume.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Finasteride
Intervention descriptions: intervention 1: Participants received 5mg of oral finasteride daily for three months.

Protocol documents:
Clinical trial NCT00849186
Conditions: Kidney Cancer
Keywords: stage I renal cell cancer stage II renal cell cancer stage III renal cell cancer stage IV renal cell cancer
Sponsor: Roswell Park Cancer Institute
Start date: 2007-08-01; Completion date: 2010-04-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This clinical trial is studying the side effects of giving sunitinib before surgery and to see how well it works in treating patients with localized or metastatic kidney cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the safety of sunitinib malate in patients with localized or metastatic renal cell carcinoma.
* Determine the safety of surgery after 90 days of treatment with sunitinib malate in these patients.

Secondary

* Determine response of these patients after 90 days of treatment with sunitinib malate.

OUTLINE: Patients receive oral sunitinib malate once daily on days 1-90 in the absence of disease progression or unacceptable toxicity. Patients then undergo radical nephrectomy.

After completion of study treatment, patients are followed for 3 months.

Arms: arm 1: None
Interventions: intervention 1: sunitinib malate intervention 2: neoadjuvant therapy intervention 3: therapeutic conventional surgery
Intervention descriptions: intervention 1: oral intervention 2: IV intervention 3: Surgery

Protocol documents:
Clinical trial NCT00850421
Conditions: Migraine Headache
Keywords: migraine headache Botulinum Toxin Type A BOTOX BTX-A
Sponsor: HealthPartners Institute
Start date: 2004-04-01; Completion date: 2010-04-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purposes of this study are to assess whether subjects treated with BOTOX will:

1. have a decrease in the frequency and intensity of migraine headaches
2. experience improvements in quality of life
3. experience a reduction in the frequency of health care services obtained.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Botulinum Toxin Type A
Intervention descriptions: intervention 1: 100 Units - Dilution: 25U/ml (4:1 BOTOX/preservative free saline)

Protocol documents:
Clinical trial NCT00850564
Conditions: Healthy Volunteers
Keywords: growth hormone releasing hormone
Sponsor: Massachusetts General Hospital
Start date: 2009-02-01; Completion date: 2010-04-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this trial is to examine the short-term effects of Growth Hormone Releasing Hormone (GHRH, tesamorelin) administration in healthy men. We hypothesize that GHRH will increase GH pulse height and will not affect insulin sensitivity.

Detailed description:
The primary objective of this study is to determine the effects of growth hormone releasing hormone (Tesamorelin) on endogenous overnight growth hormone secretion and pulsatility, as well as insulin-stimulated glucose uptake. Healthy male subjects will receive 2mg Tesamorelin, subcutaneously, daily for two weeks. At baseline and after two weeks of treatment, we will assess overnight growth hormone by frequent sampling as well as insulin stimulated glucose uptake by clamp. Subjects will then stop the Tesamorelin and will return for an identical assessment after a 2 week withdrawal period.

Arms: arm 1: Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
Interventions: intervention 1: Growth Hormone Releasing Hormone (Tesamorelin)
Intervention descriptions: intervention 1: Tesamorelin 2mg subcutaneous daily x 2 weeks

Protocol documents:
Clinical trial NCT00851409
Conditions: Genetic Disorders Hereditary Angioedema
Sponsor: Pharming Technologies B.V.
Start date: 2009-06-01; Completion date: 2010-04-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Hereditary angioedema ("HAE") is a disease characterized by recurrent tissue swelling affecting various body locations. Recent literature shows that patients with frequent attacks may benefit from long-term prophylaxis. This study aims to evaluate the safety and prophylactic effect of weekly administrations of 50 IU/kg recombinant C1 Inhibitor ("rhC1INH").

Detailed description:

Arms: arm 1: Weekly administration of 50 IU/kg Recombinant Human C1 Inhibitor
Interventions: intervention 1: Recombinant Human C1 Inhibitor
Intervention descriptions: intervention 1: 50 IU/kg "rhC1INH", "IV" injection over 4 to 5 minutes, once weekly over an 8-week treatment period.

Protocol documents:
Clinical trial NCT00853606
Conditions: Erectile Dysfunction
Keywords: ED Erectile Dysfunction Dysfunction Erectile
Sponsor: VIVUS LLC
Start date: 2009-03-01; Completion date: 2010-04-01
Enrollment: 712 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label study is being conducted to evaluate the long-term safety, tolerability, and efficacy of avanafil in men with mild to severe erectile dysfunction. Approximately 400 subjects will be enrolled and treated with avanafil for up to 52 weeks.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: avanafil
Intervention descriptions: intervention 1: All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with 100 mg may undergo dose reduction to 50 mg. Subjects who tolerate avanafil 100 mg but who desire increased efficacy may request a dose increase to 200 mg.

Protocol documents:
Clinical trial NCT00870194
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes exenatide Byetta sitagliptin Januvia Amylin Lilly
Sponsor: AstraZeneca
Start date: 2009-03-01; Completion date: 2010-04-01
Enrollment: 255 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether ceasing sitagliptin and switching to exenatide and metformin is non-inferior to adding exenatide to sitagliptin and metformin, in those patients with type 2 diabetes who are experiencing inadequate glycemic control with a combination of sitagliptin and metformin.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: exenatide and sitagliptin intervention 2: exenatide and placebo
Intervention descriptions: intervention 1: exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; sitagliptin-100mg tablet orally once a day intervention 2: exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; placebo-tablet orally once a day

Protocol documents:
Clinical trial NCT00875420
Conditions: Hot Flashes
Keywords: hot flashes hot flushes vasomotor symptoms postmenopausal
Sponsor: Radius Pharmaceuticals, Inc.
Start date: 2009-03-01; Completion date: 2010-04-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether RAD1901 is effective in decreasing hot flashes in postmenopausal women.

Detailed description:

Arms: arm 1: Oral once a day for 28 days arm 2: Oral once a day for 28 days arm 3: Oral once a day for 28 days arm 4: Oral once a day for 28 days arm 5: Oral once a day for 28 days
Interventions: intervention 1: RAD1901 intervention 2: RAD1901 intervention 3: RAD1901 intervention 4: RAD1901 intervention 5: Placebo
Intervention descriptions: intervention 1: 10 mg Oral once a day for 28 days. intervention 2: 25 mg Oral once a day for 28 days intervention 3: 50 mg Oral once a day for 28 days. intervention 4: 100 mg Oral once a day for 28 days intervention 5: Placebo Oral once a day for 28 days

Protocol documents:
Clinical trial NCT00880360
Conditions: Epithelial Ovarian Cancer Extraovarian Peritoneal Cancer Fallopian Tube Carcinoma
Keywords: Epithelial Ovarian Cancer FIGO (International Fed of Gyn and Ob)Stage III or Stage IV Extraovarian Peritoneal Cancer Fallopian Tube Carcinoma Failing
Sponsor: The University of Texas Health Science Center at San Antonio
Start date: 2007-02-01; Completion date: 2010-04-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study tests whether denileukin diftitox will deplete regulatory T cells, boost tumor-specific immunity and treat epithelial ovarian cancer in patients who have failed, or who are ineligible for front line therapy.

Detailed description:
This is a non-randomized, single-arm, Phase II trial. Selected patients with advanced-stage epithelial ovarian cancers who have no reasonable chance of cure using standard regimens, or who will not receive such regimens (due to contraindication or intolerance) are eligible. Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.

Arms: arm 1: Administration of Ontak IV for treatment of epithelial ovarian cancer
Interventions: intervention 1: Ontak
Intervention descriptions: intervention 1: Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.

Protocol documents:
Clinical trial NCT00885079
Conditions: Dry Eye Syndromes
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2009-05-01; Completion date: 2010-04-01
Enrollment: 188 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to verify whether OPC-12759 ophthalmic suspension is effective compared with active control in dry eye patients.

Detailed description:

Arms: arm 1: Instillation,4 times/day for 4 weeks arm 2: Instillation,6 times/day for 4 weeks
Interventions: intervention 1: OPC-12759 Ophthalmic suspension intervention 2: Hyalein Mini Ophthalmic solution
Intervention descriptions: intervention 1: OPC-12759 Ophthalmic suspension 2% intervention 2: Hyalein Mini Ophthalmic solution 0.1%

Protocol documents:
Clinical trial NCT00926289
Conditions: Hypertension
Sponsor: Boehringer Ingelheim
Start date: 2009-06-01; Completion date: 2010-04-01
Enrollment: 894 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this trial is to demonstrate that the fixed-dose combination of T80/HCTZ25 is superior as first line therapy in reducing seated trough cuff Systolic Blood Pressure(SBP) compared to the monotherapy of T80 in patients with grade 2 or grade 3 hypertension (SBP\>=160 mmHg and Diastolic Blood Pressure(DBP)\>=100 mmHg).

Detailed description:

Arms: arm 1: Telmisartan 80 mg arm 2: Telmisartan80mg/Hydrochlorothiazide25mg
Interventions: intervention 1: Telmisartan intervention 2: Telmisartan intervention 3: Hydrochlorothiazide
Intervention descriptions: intervention 1: Telmisartan 80mg intervention 2: Telmisartan 80mg intervention 3: Hydrochlorothiazide25mg

Protocol documents:
Clinical trial NCT00931385
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2009-06-01; Completion date: 2010-04-01
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study is intended to characterize the lung function profile of BI1744 in COPD patients where patients will perform pulmonary function tests at regular intervals for 24 hours at the end of a 6 week treatment period. Each patient will receive all four treatments.

Detailed description:

Arms: arm 1: BI1744 Low Dose once daily arm 2: BI 1744 Med Dose once daily arm 3: Placebo once daily arm 4: Foradil 12 mcg twice daily
Interventions: intervention 1: BI 1744 intervention 2: bi1744 intervention 3: Placebo intervention 4: Foradil
Intervention descriptions: intervention 1: BI1744 Respimat Med Dose Once Daily intervention 2: 1744 low dose intervention 3: Placebo Respimat and Foradil Placebo intervention 4: Foradil 12 mcg twice daily and Placebo Respimat

Protocol documents:
Clinical trial NCT00938314
Conditions: Stroke
Sponsor: Stem Cell Therapeutics Corp.
Start date: 2009-08-01; Completion date: 2010-04-01
Enrollment: 96 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is:

* To assess the neurological outcome in acute ischemic stroke patients treated with NTx®-265, when compared with patients given a placebo control.
* To assess the safety and tolerability of NTx®-265 when given to acute ischemic stroke patients.

Detailed description:

Arms: arm 1: hCG 385 µg (10,000 international unit \[IU\]), subcutaneously (SC), on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, intravenously (IV), on Day 7, 8, and 9 of study participation arm 2: hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation arm 3: hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation arm 4: None
Interventions: intervention 1: human chorionic gonadotropin (hCG), then epoetin alfa (EPO) intervention 2: human chorionic gonadotropin (hCG), then epoetin alfa (EPO) intervention 3: human chorionic gonadotropin (hCG), then epoetin alfa (EPO) intervention 4: Saline Placebo
Intervention descriptions: intervention 1: hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation intervention 2: hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation intervention 3: hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation intervention 4: Saline SC, on Day 1, 3, and 5 of study participation, then Saline IV, on Day 7, 8, and 9 of study participation

Protocol documents:
Clinical trial NCT00942448
Conditions: Dental Pain
Sponsor: IBSA Institut Biochimique SA
Start date: 2009-09-01; Completion date: 2010-04-01
Enrollment: 306 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The present study is proposed to evaluate the efficacy and safety of single doses of Diclofenac HPBCD subcutaneous (s.c.) (25 mg/1 ml and 50 mg/1 ml) in the treatment of acute moderate-to-severe pain after dental impaction surgery.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Diclofenac HPBCD intervention 2: Diclofenac HPBCD intervention 3: Diclofenac HPBCD intervention 4: Placebo s.c.
Intervention descriptions: intervention 1: 1 single injection at day of dental surgical extraction intervention 2: 1 single injection at day of dental surgical extraction intervention 3: 1 single injection at day of dental surgical extraction intervention 4: 1 single injection at day of dental surgical extraction

Protocol documents: