ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02601573
Conditions: Hepatitis C
Sponsor: Merck Sharp & Dohme LLC
Start date: 2016-01-05; Completion date: 2017-01-06
Enrollment: 101 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, multi-site, open-label trial of the co-administration of a fixed-dose combination (FDC) of EBR 50 mg + GZR (100 mg) (EBR/GZR) and SOF 400 mg, with and without RBV, in treatment-naïve (TN) and treatment-experienced (TE) participants with chronic HCV GT3 infection with compensated cirrhosis.

Detailed description:

Arms: arm 1: TN HCV GT3 participants will take 1 fixed-dose combination (FDC) tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg once-daily (q.d.) with RBV (200 mg capsules; weight-based dosing) twice-daily (b.i.d.) for 8 weeks. arm 2: TN HCV GT3 participants will take 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks. arm 3: TE HCV GT3 participants will take 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks. arm 4: TE HCV GT3 participants will take 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks. arm 5: TE HCV GT3 participants will take 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks.
Interventions: intervention 1: Grazoprevir intervention 2: Elbasvir intervention 3: Ribavirin intervention 4: Sofosbuvir
Intervention descriptions: intervention 1: GZR 100 mg is a component of the MK-5172A FDC tablet (also containing EBR 50 mg) and was taken q.d. by mouth in the morning. intervention 2: EBR 50 mg is a component of the MK-5172A FDC tablet (also containing GZR 100 mg) and was taken q.d. by mouth in the morning. intervention 3: RBV 200 mg capsules taken b.i.d. (morning and evening) by mouth at a total daily dose ranging from 800 mg to 1400 mg (total daily dose was based on participant body weight). intervention 4: SOF 400 mg tablet taken q.d. by mouth in the morning with food.

Protocol documents:
Clinical trial NCT02769702
Conditions: Uveitis
Keywords: Uveitis
Sponsor: Washington University School of Medicine
Start date: 2016-06-01; Completion date: 2017-01-06
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Uveitis is an acute or chronic inflammatory condition of unknown etiology. Although uveitis often responds adequately to topical corticosteroids, there are many patients for which this treatment is either inadequate or not tolerated. A patient with inadequate response to treatment would manifest uveitis activity by slit lamp examination determination of anterior chamber cellularity. Lack of tolerance of therapy commonly manifests as ocular hypertension (greater than 21 mmHg measured by tonometry)complicating chronic topical corticosteroid administration, leading to glaucoma and permanent visual loss. Moreover, systemic corticosteroids may be required at a dose unsafe for chronic administration. In these situations, an immunosuppressive medication is often added as a "steroid-sparing" agent. If and when there is clinical response to the added immunosuppressive, the oral and/or topical corticosteroid dose can be reduced or eliminated to avoid toxicity.

There are several reasons for believing that Acthar might be beneficial in the treatment of uveitis patients. In addition to increasing adrenal production or cortisol, Acthar has another important mechanisms of action mediated by its binding of melanocortin receptors. Melanocortin down-regulates activity of B and T lymphocytes, monocytes and macrophages. In animal studies, melanocortin peptides down-regulate T helper cells, up-regulate T Regulatory cells, and decrease B lymphocyte production of B Lymphocyte Stimulator. In macrophages, there is down-regulation of IL-1, IL-2, INF gamma, TNF alpha, nitric oxide and adhesion molecules. In other cells, in addition to IL-10 upregulation (monocytes), there is down-regulation of VACM and ECAM (endothelial cells), prostaglandins (fibroblasts) and MCP-1 and RANTES (renal tubules).CNS mediation of systemic inflammation may also be down-regulated by melanocortin receptor binding by Acthar.

Detailed description:
Patients eligible for the study will be identified by the investigators and given a copy of the consent form to read. Patients interested in enrolling will be screened and if eligible will be enrolled in the study. The screening visit and the baseline visit may occur on the same day. Patients enrolling will be instructed in self-administering Acthar 80 IU twice a week. Patients will keep an injection log which will be inspected at each visit (4, 8, and 12 weeks). Ophthalmology data will be collected at each visit and recorded on the case report form by the ophthalmology technician working with the sub-investigator at the time of each visit. Patients will come to the Center for Clinical Studies each visit for blood draw, blood pressure recording, and recording of adverse events.

Arms: arm 1: Acthar 80 IU SC twice w eek
Interventions: intervention 1: Acthar
Intervention descriptions: intervention 1: Acthar 80 IU SC twice a week

Protocol documents:
Clinical trial NCT00930579
Conditions: Breast Cancer
Keywords: Breast Cancer Metformin
Sponsor: Columbia University
Start date: 2009-10-16; Completion date: 2017-01-09
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this pilot study is to use a pre surgical intervention model to evaluate the biologic effects of metformin in women with newly diagnosed early invasive breast cancer. Metformin is a drug commonly used to treat patients with diabetes. This model will be used to evaluate the effects of metformin.

Detailed description:
Breast cancer is the most common cancer and the second leading cause of cancer death among women in the United States. Several epidemiologic studies have found an increased risk of breast cancer in women with type 2 diabetes. This association appears to be mediated by a state of hyperinsulinemia and insulin resistance. Population based studies have also found a decreased risk of cancer in diabetic patients taking metformin, an oral biguanide derivative. Proposed mechanisms include its effect on lowering serum insulin levels as well as modulation of cellular signaling pathways which inhibit tumor cellular proliferation.

Arms: arm 1: Women with newly diagnosed early invasive breast cancer will receive Metformin
Interventions: intervention 1: Metformin
Intervention descriptions: intervention 1: 1500 mg per day, divided 500 mg in the morning and 1000 mg in the evening, for at least two weeks prior to surgery

Protocol documents:
Clinical trial NCT02537574
Conditions: Opioid Use Disorder
Keywords: Alkermes Buprenorphine Naltrexone Vivitrol Opioid Use Opiates Dependence Abuse Heroin Painkillers Substance Abuse
Sponsor: Alkermes, Inc.
Start date: 2015-08-01; Completion date: 2017-01-09
Enrollment: 380 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety, effectiveness and tolerance of low doses of oral naltrexone along with buprenorphine to treat opioid use disorder prior to the first injection of VIVITROL.

Detailed description:

Arms: arm 1: Oral naltrexone + sublingual buprenorphine arm 2: Oral naltrexone + sublingual placebo arm 3: Oral placebo naltrexone + sublingual placebo buprenorphine
Interventions: intervention 1: NTX/BUP intervention 2: NTX/PBO-B intervention 3: PBO-N/PBO-B
Intervention descriptions: intervention 1: Daily doses intervention 2: Daily doses intervention 3: Daily doses

Protocol documents:
Clinical trial NCT02513771
Conditions: HIV-1 Infection
Keywords: Sitagliptin Inflammation Immune activation Viral suppression HIV-1 Immunology biomarkers sCD14
Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Start date: 2015-09-01; Completion date: 2017-01-10
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate whether sitagliptin (Januvia is the brand name for sitagliptin) reduces inflammation and immune activation markers in HIV-infected men and women when compared to a placebo (inactive medication like a dummy pill). The study evaluated whether taking 100 mg of sitagliptin by mouth daily for 16 weeks is safe and effective for HIV-infected persons on antiretroviral therapy (ART) who do not have diabetes. Sitagliptin is a medication that is used to treat people with diabetes (high blood sugar) but also may reduce inflammation in the body.

Detailed description:
ACTG A5346 is a phase II, randomized, double-blinded, placebo-controlled, trial of sitagliptin 100 mg vs. placebo for 16 weeks followed by a 4-week post-intervention follow-up. A5346 studied whether sitagliptin reduced plasma concentrations of sCD14 in HIV-infected men and women ≥18 years of age who were on suppressive ART with HIV-1 RNA below the limit of quantification at screening and for at least the prior 48 weeks. Participants were randomized 1:1 to Sitagliptin arm vs. Placebo arm, and were stratified by screening CD4 count (100-350 vs. \>350 cells/mm\^3) and statin use (on statins vs. not on statins).

Arms: arm 1: Sitagliptin (Januvia) 100 mg one tablet daily p.o. for 16 weeks, followed by a 4-week post-treatment follow-up. arm 2: Placebo for sitagliptin one tablet daily p.o.for 16 weeks, followed by a 4-week post-treatment follow-up.
Interventions: intervention 1: Sitagliptin intervention 2: Placebo for sitagliptin
Intervention descriptions: intervention 1: 100 mg one tablet taken orally daily for 16 weeks, followed by a 4-week post-treatment follow-up intervention 2: One tablet taken orally daily for 16 weeks, followed by a 4-week post-treatment follow-up.

Protocol documents:
Clinical trial NCT02760056
Conditions: Multiple Sclerosis
Keywords: Thyroid hormone Remyelination
Sponsor: Oregon Health and Science University
Start date: 2016-06-06; Completion date: 2017-01-10
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This is a phase 1 study evaluating the safety and maximum tolerated dose of Liothyronine (T3) in subjects with multiple sclerosis

Detailed description:
This is a pilot, phase I, placebo controlled clinical trial of short-term high-dose thyroid hormone to promote remyelination in MS. Permanent clinical disability in MS is likely caused by the neuronal damage and degeneration that follows recurrent demyelination with progressive failure of remyelination. Thyroid hormone (TH) is required for central nervous system (CNS) myelination during development, and CNS remyelination in animal models of MS, a process similar to developmental myelination, has also been found to be promoted by TH. This study will ascertain the safety, tolerability and maximum tolerated dose of TH in people with MS, explore reliability for a potential signal of treatment efficacy and mechanism, and optimize procedures for a full scale clinical trial to evaluate the efficacy of pulsed TH for promotion of remyelination in MS.

The safety and tolerability of this treatment will be assessed using subjects' self-report of symptoms, the validated Hyperthyroid Symptom Scale (HSS), and blood pressure measurements. a

Arms: arm 1: Subjects will be divided into 4 groups. The first group will take 25 mcg twice daily for one week. The second group will take 37.5 mcg twice daily for one week. The third group will take 50 mcg twice daily for one week. The firth group will take 75 mcg twice daily for one week arm 2: Subject will take matching placebo twice a day for one week
Interventions: intervention 1: Liothyronine sodium intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects will be divided into 4 groups of progressively escalating doses. Each group will have 6 subjects 4 will receive the active treatment and 2 will receive the placebo. The first group will receive 25 mcg twice daily for one week. The second group will receive 37.5 mcg twice daily for one week. The third group will receive 50 mcg twice daily for one week. The forth group will receive 75 mcg twice daily for one week. intervention 2: Patient will receive a matching placebo to take twice daily for one week.

Protocol documents:
Clinical trial NCT01741532
Conditions: Pantothenate Kinase-Associated Neurodegeneration
Keywords: Pantothenate Kinase-associated Neurodegeneration PKAN NBIA Deferiprone Ferriprox Neurodegeneration with brain iron accumulation
Sponsor: ApoPharma
Start date: 2012-12-13; Completion date: 2017-01-11
Enrollment: 89 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A multi-center, placebo controlled, double-blind trial comparing the efficacy and safety of 18 months of treatment with deferiprone versus placebo in patients with PKAN.

This investigator-initiated trial was funded by the European Commission's Seventh Framework Programme (FP7/2007-2013, HEALTH-F2-2011, grant agreement No. 277984) to the TIRCON consortium (Treat Iron-Related Childhood-Onset Neurodegeneration) and by the FDA Office of Orphan Products Development (OOPD) (Dr. Elliott Vichinsky).

Detailed description:
This is a multi-center, double-blind, randomized, placebo-controlled, 18-month study in patients with PKAN aged 4 years and older. Participants are randomized in a 2:1 ratio to receive either deferiprone oral solution or placebo, twice a day for 18 months. Efficacy assessments, an MRI scan to measure iron levels in the globus pallidus, pharmacokinetic evaluations, and safety assessments are conducted at specified time points. Following completion of the trial, eligible patients are invited to enroll in an 18-month extension study, TIRCON2012V1-EXT, in which all participants receive deferiprone.

Arms: arm 1: Deferiprone 80 mg/mL oral solution arm 2: Matching placebo solution
Interventions: intervention 1: Deferiprone oral solution intervention 2: Placebo
Intervention descriptions: intervention 1: Deferiprone 80 mg/mL oral solution will be administered twice daily (b.i.d.) for 18 months. An initial dose of 5 mg/kg b.i.d. will be administered for 6 weeks. The dose will then be escalated to 10 mg/kg b.i.d. and finally to 15 mg/kg b.i.d. intervention 2: A deferiprone matching placebo oral solution will be given twice daily for 18 months.

Protocol documents:
Clinical trial NCT02607800
Conditions: Hepatitis C
Keywords: Chronic Hepatitis C Infection
Sponsor: Gilead Sciences
Start date: 2015-11-16; Completion date: 2017-01-11
Enrollment: 943 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this study are to compare the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) for 8 weeks with that of SOF/VEL FDC for 12 weeks in direct-acting antiviral-naive participants with chronic hepatitis C virus (HCV) infection.

Detailed description:

Arms: arm 1: SOF/VEL/VOX tablet for 8 weeks arm 2: SOF/VEL tablet for 12 weeks
Interventions: intervention 1: SOF/VEL/VOX intervention 2: SOF/VEL
Intervention descriptions: intervention 1: 400/100/100 mg tablet administered orally once daily with food intervention 2: 400/100 mg tablet administered orally once daily with or without food

Protocol documents:
Clinical trial NCT02625922
Conditions: Chronic Heart Failure
Keywords: Serelaxin, Chronic heart failure, Spiroergometry, Troponin, New York Heart Association (NYHA) functional Class II/III, Left ventricular ejection fraction,
Sponsor: Novartis Pharmaceuticals
Start date: 2016-02-05; Completion date: 2017-01-11
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This was a multicenter, randomized, double-blind, crossover, placebo-controlled, Phase II clinical study that evaluated the effect of serelaxin versus placebo (both in addition to SoC) on the release of hs-cTnI, in patients with CHF after an exercise testing session.

Detailed description:

Arms: arm 1: On Day 1 of treatment period 1, Serelaxin will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen The routine exercise assessment will commence at minute 120. In treatment period 2, on day 15 ± 1-day washout, matching placebo will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen. arm 2: On Day 1 of treatment period 1, matching placebo will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen The routine exercise assessment will commence at minute 120. In treatment period 2, on day 15 ± 1-day washout, Serelaxin will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen.
Interventions: intervention 1: Serelaxin intervention 2: Placebo
Intervention descriptions: intervention 1: Serelaxin will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen intervention 2: Matching placebo i.v infusion

Protocol documents:
Clinical trial NCT02651155
Conditions: Constipation
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2016-03-02; Completion date: 2017-01-11
Enrollment: 204 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of oral administration of lubiprostone 24 μg twice daily (BID) for 4 weeks in participants with chronic idiopathic constipation (CIC) compared with placebo.

Detailed description:
The drug being tested in this study is called lubiprostone. Lubiprostone is being tested to treat people who have chronic idiopathic constipation. This study will look at the frequency of spontaneous bowel movements (SBMs) in people who take lubiprostone compared to placebo.

The study will enroll approximately 204 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups, such that equal numbers of subjects will be in each treatment group-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

* Lubiprostone 24 μg
* Placebo (dummy inactive pill) - this is a capsule that looks like the study drug but has no active ingredient

All participants will be asked to take one capsule with breakfast and one capsule with dinner each day throughout the study. All participants will be asked to record each time they have a SBM and all details of each SBM (including the consistency of the stool and the difficulty they have in passing it) in a diary.

This multi-center trial will be conducted in Russia. The overall time to participate in this study is 8 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment.

Arms: arm 1: Lubiprostone 24 μg, capsules, orally, twice daily, under fed conditions, for 4 weeks. arm 2: Lubiprostone placebo-matching capsules, orally, twice daily, under fed conditions, for 4 weeks.
Interventions: intervention 1: Lubiprostone intervention 2: Placebo
Intervention descriptions: intervention 1: Lubiprostone capsules intervention 2: Lubiprostone placebo-matching capsules

Protocol documents:
Clinical trial NCT02187471
Conditions: Pain Associated With Fibromyalgia
Keywords: pain fibromyalgia
Sponsor: Daiichi Sankyo
Start date: 2015-01-16; Completion date: 2017-01-12
Enrollment: 1301 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objective of this trial is to compare change in weekly average daily pain score (ADPS) from baseline to Week 13 in participants receiving either dose of DS-5565 versus placebo.

Weekly ADPS is based on daily pain scores reported by the subject that best describes his or her worst pain over the previous 24 hours.

Detailed description:

Arms: arm 1: Participants take one each of placebo tablet and capsule, twice daily (BID) arm 2: Participants take one pregabalin capsule and one placebo tablet BID arm 3: Participants take one each of placebo tablet and capsule in the morning and one placebo capsule in the evening with one DS-5565 tablet once daily (QD) arm 4: Participants take one placebo capsule with one DS-5565 tablet BID
Interventions: intervention 1: DS-5565 intervention 2: Pregabalin intervention 3: Placebo tablet intervention 4: Placebo capsule
Intervention descriptions: intervention 1: DS-5565 15 mg QD or BID; tablet for oral use intervention 2: Pregabalin capsule for oral use; 75 mg capsule for one week, then 150 mg capsule intervention 3: Placebo tablet for oral use, matching DS-5565 tablet intervention 4: Placebo capsule for oral use, matching pregabalin capsule

Protocol documents:
Clinical trial NCT02322866
Conditions: Acne Vulgaris
Keywords: acne
Sponsor: Almirall, S.A.
Start date: 2014-12-03; Completion date: 2017-01-12
Enrollment: 1034 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy and safety of an approximate 1.5 mg/kg/day dose of oral sarecycline compared to placebo in the treatment of moderate to severe facial acne vulgaris

Detailed description:

Arms: arm 1: Sarecycline tablets, 1.5 milligram(mg)/kilogram(kg)/day, taken orally once daily for 12 weeks. arm 2: Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Interventions: intervention 1: Sarecycline intervention 2: Placebo
Intervention descriptions: intervention 1: 1.5 mg/kg/day taken orally at the same time each day. intervention 2: Placebo-matching sarecycline tablets, taken orally at the same time each day.

Protocol documents:
Clinical trial NCT02691702
Conditions: Healthy Adult Subjects Healthy Elderly Subjects
Keywords: Multiple Ascending Dose Study Safety and Tolerability Pharmacokinetics Pharmacodynamics Melatonin Plasma Dim Light Melatonin Onset
Sponsor: Biogen
Start date: 2016-03-28; Completion date: 2017-01-12
Enrollment: 97 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is the first clinical trial to evaluate ascending multiple oral doses in healthy adult and healthy elderly subjects to characterize the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BIIB118

Detailed description:
This study was previously posted by Pfizer. In March, 2020, sponsorship of the trial was transferred to Biogen.

Arms: arm 1: Multiple ascending doses administered in the morning to healthy adult subjects in a parallel study design arm 2: Multiple ascending doses administered in the evening to healthy adult subjects in a parallel study design arm 3: Multiple ascending doses administered to elderly subjects
Interventions: intervention 1: BIIB118 intervention 2: Melatonin
Intervention descriptions: intervention 1: Multiple ascending doses of BIIB118 (50 mg, 150 mg, 450 mg and 900 mg) as extemporaneously prepared solution/suspension administered once daily over 2 weeks intervention 2: Positive control used to assess the validity of DLMO as pharmacodynamic endpoint.

Protocol documents:
Clinical trial NCT00274469
Conditions: Metastatic Breast Cancer
Keywords: oncology cancer breast cancer
Sponsor: AstraZeneca
Start date: 2006-02-06; Completion date: 2017-01-13
Enrollment: 205 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy and tolerability of Faslodex (fulvestrant) with Arimidex (anastrozole) in postmenopausal women with hormone receptor positive advanced breast cancer.

Detailed description:

Arms: arm 1: Fulvestrant arm 2: Anastrozole
Interventions: intervention 1: fulvestrant intervention 2: anastrozole
Intervention descriptions: intervention 1: 500 mg intramuscular injection intervention 2: 1 mg oral tablet

Protocol documents: