ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01524978
Conditions: Multiple Myeloma, Neoplasms
Sponsor: Hoffmann-La Roche
Start date: 2012-04-12; Completion date: 2016-10-28
Enrollment: 208 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This open-label, multi-center study will assess the efficacy and safety of vemurafenib in participants with BRAF V600 mutation-positive cancers (solid tumors and multiple myeloma, except melanoma and papillary thyroid cancer) and for whom vemurafenib is deemed the best treatment option in the opinion of the investigator. Participants will receive twice daily oral doses of 960 mg vemurafenib until disease progression, unacceptable toxicity, or withdrawal of consent. The safety and efficacy of vemurafenib in combination with cetuximab in a subset of participants with colorectal cancer will also be assessed.

Detailed description:

Arms: arm 1: Participants with NSCLC will be treated with vemurafenib monotherapy. arm 2: Participants with ovarian cancer will be treated with vemurafenib monotherapy. arm 3: Participants with colorectal cancer will be treated with vemurafenib monotherapy. arm 4: Participants with colorectal cancer will be treated with vemurafenib and cetuximab combination therapy. arm 5: Participants with cholangiocarcinoma will be treated with vemurafenib monotherapy. arm 6: Participants with multiple myeloma will be treated with vemurafenib monotherapy. arm 7: Participants with Erdheim-Chester disease (ECD), Langerhans cell histiocytosis (LCH), anaplastic thyroid cancer, advanced stage astrocytoma, early stage astrocytoma and other BRAF V600-positive tumors will be treated with vemurafenib monotherapy. Subcohorts will be analyzed separately if 7 or more participants are enrolled for each indication.
Interventions: intervention 1: cetuximab intervention 2: vemurafenib intervention 3: vemurafenib
Intervention descriptions: intervention 1: Escalating doses administered on Day 1 and then once weekly by intravenous infusion. intervention 2: Escalating doses given orally twice a day starting on Day 2 intervention 3: 960 mg vemurafenib orally twice a day until disease progression, unacceptable toxicity, or withdrawal of consent.

Protocol documents:
Clinical trial NCT01942668
Conditions: Menopause
Keywords: Vasomotor symptoms Hot flashes Endometrial protection
Sponsor: TherapeuticsMD
Start date: 2013-08-05; Completion date: 2016-10-28
Enrollment: 1845 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will be a prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter trial of postmenopausal subjects with an intact uterus.

Detailed description:
Postmenopausal subjects with an intact uterus who meet the study entry criteria will be randomized to one of five treatment arms (four active and one placebo) and followed for 12 months. During the Screening period all subjects will be provided with a diary to self-assess the frequency and severity of their vasomotor symptoms. Subjects experiencing a minimum daily frequency of ≥7 (or ≥50 per week) moderate to severe hot flushes will participate in a VMS Substudy during the first 12 weeks of treatment. The Substudy subjects will be stratified by treatment arm within the sites, and only Substudy subjects have the possibility of being randomized to placebo. Subjects who qualify for the study except for experiencing a minimum daily frequency of ≥7 (or ≥50 per week) moderate to severe hot flushes will be stratified within sites to one of the four active treatment arms and followed for 12 months, but will not participate in the VMS Substudy. (However, VMS information will be collected from all subjects during the first 12 weeks of treatment.) All Study Subjects: Postmenopausal women with an intact uterus who seek relief from hot flushes and meet all other inclusion/exclusion criteria are eligible for 12 months of study treatment.

VMS Substudy Subjects: A subset of All Study Subjects who have ≥7 per day or ≥50 per week moderate to severe hot flushes (as determined during Screening) are eligible for the 12-week VMS Substudy and for a total of 12 months of study treatment.

Clinical evaluations will be performed at the following time points:

* Screening Period (Week: - 8.5) (up to -60 Days)
* Visit 1 Randomization (Week 0) (Day 1)
* Visit 2 Interim (Week 4)
* Visit 3 Interim (Week 8)
* Visit 4 Interim (Week 12)
* Visit 5 Interim (Month 6)
* Visit 6 Interim (Month 9)
* Visit 7 End of Treatment (Month 12)

Arms: arm 1: Combined Estradiol 1 mg / Progesterone 100 mg softgel capsule formulation and placebo taken orally once a day for twelve months. arm 2: Combined Estradiol 0.5 mg / Progesterone 100 mg softgel capsule formulation and placebo taken orally once a day for twelve months. arm 3: Combined Estradiol 0.5 mg / Progesterone 50 mg softgel capsule formulation and placebo, taken orally once a day for twelve months. arm 4: Combined Estradiol 0.25 mg / Progesterone 50 mg softgel capsule formulation and placebo, taken orally once a day for twelve months. arm 5: Two Placebo softgel capsules taken orally once a day for twelve months.
Interventions: intervention 1: Estradiol intervention 2: Progesterone intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01967225
Conditions: Skin Diseases, Infectious
Keywords: Methicillin Resistant Staphylococcus Aureus, Skin and soft tissue infection, Bacteremia, Tedizolid
Sponsor: Bayer
Start date: 2013-11-23; Completion date: 2016-10-28
Enrollment: 125 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to see the efficacy and safety of BAY1192631 in Japanese patients with methicillin-resistant staphylococcus aureus (MRSA) (skin and soft tissue infections (SSTI) and SSTI-related bacteremia).

Detailed description:

Arms: arm 1: Participants received 200 mg BAY1192631 solution or tablet once daily (intravenous (I.V.) or oral (PO)) arm 2: Participants received 600 mg Linezolid solution or tablet twice daily, every 12 ± 3 hours (intravenous (I.V.) or oral (PO))
Interventions: intervention 1: Tedizolid Phosphate (Sivextro, BAY1192631) intervention 2: Linezolid
Intervention descriptions: intervention 1: BAY1192631 solution or tablet 200 mg, once daily, Intravenous (IV) or By Mouth (PO) for 7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia. intervention 2: Linezolid solution or tablet 600 mg, twice daily, every 12 ±3 hours, Intravenous (IV) or By mouth (PO) 7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia.

Protocol documents:
Clinical trial NCT02333045
Conditions: HIV
Keywords: HIV-negative Women At-risk
Sponsor: Emory University
Start date: 2015-01-01; Completion date: 2016-10-28
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study seeks to understand the immune cells in the cervical fluid of in the blood and genital tract of HIV-negative healthy female volunteers and to see if these cells can be modified using a combined anti-viral and antiinflammatory drug called maraviroc, a medicine used in the treatment of HIV infection.

Detailed description:
In this study, the investigator seeks to understand the immune cells in the cervical fluid of HIV-negative healthy female volunteers, and to see if these cells can be modified using a combined anti-viral and antiinflammatory drug called maraviroc, a medicine used in the treatment of HIV infection. Maraviroc works by preventing HIV from entering human immune cells by blocking a protein on the outside of these cells called the C-C chemokine receptor type 5 (CCR5) receptor. When maraviroc is bound to this protein, the virus cannot enter the cell. The investigator thinks that CCR5 antagonists could be particularly good drugs for HIV pre-exposure prophylaxis (PrEP) and could potentially be dosed in ways that are easier to take than the current drugs used for PrEP.

In order to further evaluate this PrEP strategy, the investigator will first study the immune cells in the blood and genital tract of HIV-negative healthy female volunteers over the course of 3 months to see how these cells change over time and are affected by factors such as age, menstrual cycle, and genital infections.

The amount of maraviroc compared with the drugs in the current drugs used for PrEP (tenofovir/ emtricitabine) in the blood and genital tract of HIV-negative healthy female volunteers before, during, and after they are given maraviroc versus tenofovir/ emtricitabine for 7 days will be measured. We will also study immune cells from the blood and genital tract from these women to see if maraviroc, tenofovir, or emtricitabine have an effect on these cells that would prevent them from becoming infected with HIV.

Arms: arm 1: Women will be assigned at random Truvada 1 tablet PO daily arm 2: Women will be assigned at random Maraviroc 300 mg PO daily
Interventions: intervention 1: Truvada qd intervention 2: Maraviroc 300 qd
Intervention descriptions: intervention 1: Truvada 1 tablet PO daily for 7 days intervention 2: Maraviroc 300 mg PO daily for 7 days

Protocol documents:
Clinical trial NCT01214083
Conditions: Alcoholism
Keywords: N-acetylcysteine naltrexone
Sponsor: VA Office of Research and Development
Start date: 2010-10-15; Completion date: 2016-10-30
Enrollment: 111 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether: (1) the combination of N-acetylcysteine + high-dose naltrexone (150 mg) works better than high-dose naltrexone (150 mg) alone in reducing alcohol drinking; and (2) high-dose naltrexone (150 mg) alone works better than low-dose naltrexone (50 mg) alone in reducing alcohol drinking.

Detailed description:
The 3 groups (N-acetylcysteine plus naltrexone 150 mg, naltrexone 150 mg, and naltrexone 50 mg) will be compared in a 12-week randomized, double-blind clinical trial.

Arms: arm 1: N-acetylcysteine + high-dose naltrexone (150 mg) arm 2: High-dose naltrexone (150 mg) alone arm 3: Low-dose naltrexone (50 mg) alone
Interventions: intervention 1: N-acetylcysteine + high-dose naltrexone (150 mg) intervention 2: High-dose naltrexone (150 mg) alone intervention 3: Low-dose naltrexone (50 mg) alone
Intervention descriptions: intervention 1: All subjects will be evaluated weekly for 12 weeks. intervention 2: All subjects will be evaluated weekly for 12 weeks. intervention 3: All subjects will be evaluated weekly for 12 weeks.

Protocol documents:
Clinical trial NCT00314795
Conditions: Anemia Chronic Kidney Disease Chronic Renal Failure Pure Red Cell Aplasia
Keywords: Drug Therapy pure red cell aplasia PRCA chronic kidney disease CKD chronic renal failure CRF anemia erythropoietin EPO erythropoiesis stimulating agent ESA hemoglobin Hb Hgb red blood cell red blood cell production
Sponsor: Takeda
Start date: 2006-04-06; Completion date: 2016-10-31
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the ability of peginesatide (AF37702) to increase and maintain increased hemoglobin levels in participants with chronic kidney disease (CKD) (either not on dialysis, receiving regular hemodialysis or peritoneal dialysis, or following renal transplant) with confirmed antibody-mediated pure red cell aplasia (PRCA).

Detailed description:
The drug being tested in this study was peginesatide. Peginesatide injection was tested to investigate the efficacy and safety in the treatment of anemia caused by antibody-mediated pure red cell aplasia in participants with chronic kidney disease.

The study enrolled 22 patients. All the participants enrolled into the study received:

• Peginesatide 0.5 mg/kg subcutaneous (SC) injection

The participants received a starting dose of 0.05 mg/kg (every 4 weeks) followed by 0.1 mg/kg dose, based on the assessment of the dose response in the initial group of 5 participants. The frequency of each injection and the dose adjusted based on the participant's hemoglobin response and the ability to maintain a hemoglobin level in the range of 10.0-12.0 g/dL.

This multi-center trial was conducted in Europe. The overall time to participate in this study was 10 years and 7 months approximately. Participants made multiple visits to the clinic until the projected end of treatment period, which was 31-Oct-2016.

Arms: arm 1: Peginesatide 0.05 mg/kg injection, subcutaneously as a starting dose followed by peginesatide 0.1 mg/kg injection, subcutaneously once every 4 weeks for up to 6 months.

Individual dose of peginesatide injection was modified based on hemoglobin levels. Dose adjustments were made in order to achieve and maintain hemoglobin in the target range of 10.0-12.0 g/dL.
Interventions: intervention 1: Peginesatide
Intervention descriptions: intervention 1: Peginesatide injection

Protocol documents:
Clinical trial NCT00903786
Conditions: Refractory Partial Seizures
Keywords: Seizure epilepsy
Sponsor: Eisai Co., Ltd.
Start date: 2009-06-17; Completion date: 2016-10-31
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this trial is to investigate the safety and tolerability of perampanel in long- term treatment in the patients with refractory partial epilepsy (uncontrolled with other anti-epileptic drugs) who completed Week 10 of Phase II Study E2007-J081-231 study.

Detailed description:

Arms: arm 1: Participants were treated with the perampanel dose that was administered in maintenance period of Study E2007-J081-231 (Study 231) \[NCT00849212\]. In some instances, a 1-step down-titration from the viewpoint of safety and up-titration to the maintenance dose of Study 231 was allowed. In general, 1 to 6 tablets of perampanel was administered orally as a 2-milligram (mg) tablet (2 mg to 12 mg) once daily before bedtime (under fed conditions as much as possible).

The investigator, or subinvestigator, was allowed to complete the treatment by tapering the study drug after end of treatment or discontinuation (Follow-up Period), as appropriate. The taper period was 4 weeks at the longest.
Interventions: intervention 1: perampanel
Intervention descriptions: intervention 1: Patients will receive the same oral dosage (2 mg up to 12 mg once daily before bedtime) as used in the maintenance period of Study 231.

Protocol documents:
Clinical trial NCT01387607
Conditions: Fibromyalgia
Keywords: Pregabalin fibromyalgia
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2012-02-06; Completion date: 2016-10-31
Enrollment: 343 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and tolerability of pregabalin compared with placebo for management of fibromyalgia in adults.

Detailed description:

Arms: arm 1: None arm 2: Matched placebo
Interventions: intervention 1: pregabalin intervention 2: placebo
Intervention descriptions: intervention 1: Pregabalin capsule, 300-450mg/day, twice daily intervention 2: Placebo, twice daily

Protocol documents:
Clinical trial NCT01939301
Conditions: Pulmonary Embolism
Keywords: Pulmonary embolism clot
Sponsor: Indiana University School of Medicine
Start date: 2013-10-01; Completion date: 2016-10-31
Enrollment: 78 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized study to treat subjects diagnosed with pulmonary embolism with inhaled nitric oxide or placebo (oxygen).

Detailed description:
This is a randomized, double blind study to treat subjects diagnosed with pulmonary embolism with inhaled nitrix oxide. In this clinical trial investigators will randomized patients to receive inhaled nitric oxide or sham (nitrogen + oxygen) for 24 hours. Patients must have a submassive pulmonary embolism (PE) and evidence of right ventricular (RV) heart dysfunction. Investigators hypothesize that the administration of inhaled NO + oxygen to patients with severe submassive PE will improve RV function, reduce RV strain and necrosis and improve dyspnea (difficulty breathing) more than sham oxygen treatment.

Arms: arm 1: Inhaled nitric oxide arm 2: Oxygen
Interventions: intervention 1: Inhaled Nitric Oxide intervention 2: Sham
Intervention descriptions: intervention 1: Nitric Oxide + oxygen intervention 2: Nitrogen + Oxygen

Protocol documents:
Clinical trial NCT02115386
Conditions: Philadelphia Positive (Ph+) Chronic Myeloid Leukemia
Keywords: Ph+ CML, chronic myeloid leukemia
Sponsor: Novartis Pharmaceuticals
Start date: 2015-12-17; Completion date: 2016-10-31
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objective for this study is to evaluate changes in chronic low grade non-hematological adverse events experienced by patients who have been treated with at least 6 months of imatinib and who have not responded to supportive measures, when they are switched to nilotinib (CTCAE grading system).

Detailed description:
Study was terminated by Novartis

Arms: arm 1: Dosage was 300 mg BID daily taken orally without food.
Interventions: intervention 1: Nilotinib
Intervention descriptions: intervention 1: supplied in 150 mg capsules to be taken orally

Protocol documents:
Clinical trial NCT02442284
Conditions: Chronic Hepatitis C Cirrhosis Hepatitis C Virus
Keywords: Chronic Hepatitis C Interferon-Free Hepatitis C Genotype 1 Hepatitis C Virus Hepatitis C Cirrhosis
Sponsor: AbbVie
Start date: 2015-05-13; Completion date: 2016-10-31
Enrollment: 99 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in US veterans with genotype 1 chronic hepatitis C virus infection.

Detailed description:

Arms: arm 1: 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis.
Interventions: intervention 1: ombitasvir/paritaprevir/ritonavir and dasabuvir intervention 2: Ribavirin
Intervention descriptions: intervention 1: Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet intervention 2: Tablet

Protocol documents:
Clinical trial NCT02821910
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2016-07-20; Completion date: 2016-10-31
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combinations (FDC) tablets containing empagliflozin, linagliptin \& metformin extended release (XR) and the single tablets of empagliflozin, linagliptin and metformin XR administered simultaneously.

Detailed description:

Arms: arm 1: 1 fixed dose combination (FDC) tablet vs. 4 single tablets under fed conditions arm 2: 1 fixed dose combination (FDC) tablet vs. 4 single tablets under fasted conditions arm 3: 1 fixed dose combination (FDC) tablet vs. 4 single tablets under fed conditions
Interventions: intervention 1: High dose FDC Empagliflozin/Linagliptin/Metformin XR, fed intervention 2: 1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR intervention 3: High dose FDC Empagliflozin/Linagliptin/Metformin XR, fasted intervention 4: 1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR intervention 5: Low dose FDC Empagliflozin/Linagliptin/Metformin XR, fed intervention 6: 1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR
Intervention descriptions: intervention 1: High dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet intervention 2: 1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets intervention 3: High dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet intervention 4: 1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets intervention 5: Low dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet intervention 6: 1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets

Protocol documents:
Clinical trial NCT00364351
Conditions: Non Small Cell Lung Cancer
Keywords: Non Small Cell Lung Cancer NSCLC
Sponsor: Genzyme, a Sanofi Company
Start date: 2006-08-01; Completion date: 2016-11-01
Enrollment: 1574 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine if ZD6474 a new investigational drug, is effective in treating Non Small Lung Cancer and if so, how it compares with another type of anti cancer therapy chemotherapy, Erlotinib

Detailed description:

Arms: arm 1: Erlotinib arm 2: Vandetanib
Interventions: intervention 1: Vandetanib intervention 2: Erlotinib
Intervention descriptions: intervention 1: once daily oral tablet intervention 2: oral dose

Protocol documents:
Clinical trial NCT01725152
Conditions: Fragile x Syndrome
Keywords: fragile x syndrome ganaxolone anxiety attention pediatric
Sponsor: Marinus Pharmaceuticals
Start date: 2012-11-01; Completion date: 2016-11-01
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This Phase 2 proof-of-concept study is a double-blind, randomized, placebo-controlled, crossover study to investigate ganaxolone treatment in children with fragile x syndrome (FXS). The objective of the study is to assess the safety, tolerability and efficacy of ganaxolone in the treatment of anxiety and attention in subjects with FXS.

Detailed description:
This is a single center study conducted at University of California Davis (UCD) MIND Institute. Children with FXS between the ages of 6-17 years, inclusive will be randomized at a 1:1 ratio to receive ganaxolone or placebo treatment for 6 weeks, discontinue treatment and washout for 2 weeks, and then cross over to the opposite treatment for another 6 weeks.

Arms: arm 1: Participants first received ganaxolone. They were first titrated up to the 12 milligram per kilogram (mg/kg) three times daily (tid) during a 2-week titration phase, then maintained on that dose for an additional 4 weeks. After a washout period of 2 weeks, participants received placebo for a duration of 6 weeks (from week 8 to 14). arm 2: Participants first received placebo. They were first titrated up to the 12 mg/kg tid during a 2-week titration phase, then maintained on that dose for an additional 4 weeks. After a washout period of 2 weeks, participants received ganaxolone for a duration of 6 weeks (from week 8 to 14).
Interventions: intervention 1: Ganaxolone intervention 2: Placebo
Intervention descriptions: intervention 1: oral suspension, given in 3 divided doses intervention 2: oral suspension, given in 3 divided doses

Protocol documents: