ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01593215
Conditions: Type 2 Diabetes
Keywords: genetics type 2 diabetes insulin secretion
Sponsor: Anders Rosengren, MD PhD
Start date: 2012-05-01; Completion date: 2014-10-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The investigators have recently discovered a genetic variant in an adrenergic receptor that leads to increased risk for type 2 diabetes. The investigators have also seen that blockers of that receptor improves impaired insulin secretion in animals. The investigators will now test the blocker in patients with type 2 diabetes with or without the risk variant in an effort to make diabetes treatment more individualized.

Detailed description:
We have recently discovered a genetic variant in an adrenergic receptor that leads to increased risk for type 2 diabetes. We have also seen that blockers of that receptor improves impaired insulin secretion in animals. We will now test the blocker in patients with type 2 diabetes with or without the risk variant in an effort to make diabetes treatment more individualized. Patients will receive two different doses of the blocker and the effect will be measured with oral glucose tolerance tests. The study is a randomized placebo-controlled study.

Arms: arm 1: placebo first, then yohimbine arm 2: Yohimbine first then placebo
Interventions: intervention 1: Yohimbine
Intervention descriptions: intervention 1: Yohimbine capsule

Protocol documents:
Clinical trial NCT01596335
Conditions: Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin
Keywords: Infliximab REMICADE TA-650 intravenous immunoglobulin Kawasaki disease IVIG
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2012-05-01; Completion date: 2014-10-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of TA-650 in comparison with a control drug Polyethylene Glycol-treated Human Immunoglobulin (VGIH) in patients with Kawasaki disease refractory to initial therapy with Intravenous Immunoglobulin (IVIG). The pharmacokinetics of TA-650 is also examined.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: TA-650 intervention 2: Polyethylene Glycol-treated Human Immunoglobulin (VGIH)
Intervention descriptions: intervention 1: TA-650 at 5 mg per kg body weight on the day of TA-650 administration (day 0) is administered by intravenous infusion slowly over at least 2 hours. intervention 2: VGIH at 2 g per kg body weight on the day of VGIH administration (day 0) is administered by intravenous infusion slowly over at least 20 hours.

Protocol documents:
Clinical trial NCT01639703
Conditions: Hepatocellular Carcinoma
Keywords: CT perfusion Hepatocellular Carcinoma Xenetix Contrast agent
Sponsor: Guerbet
Start date: 2012-04-01; Completion date: 2014-10-01
Enrollment: 96 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to prospectively determine the diagnostic value of Xenetix-CT perfusion for the discrimination between well-differentiated hepatocellular carcinomas (HCC) and poorly/moderately differentiated HCC, in histo-pathologically proven HCC, and with the aim to cover the entire liver.

Detailed description:

Arms: arm 1: arm with CT perfusion
Interventions: intervention 1: Xenetix-CT perfusion imaging
Intervention descriptions: intervention 1: Injection of 50 ml of Xenetix

Protocol documents:
Clinical trial NCT01646255
Conditions: Idiopathic Parkinson's Disease
Keywords: Rotigotine Neupro phase 3 Advanced-stage Idiopathic Parkinson's Disease
Sponsor: UCB Pharma
Start date: 2012-07-01; Completion date: 2014-10-01
Enrollment: 346 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study was to demonstrate that Rotigotine transdermal patch is efficacious in Chinese subjects with advanced-stage Idiopathic Parkinson's Disease as an adjuvant therapy.

Detailed description:
The study included a maximum 4-week Screening Period, a maximum 7-week Titration Period for advanced-stage Parkinson's disease, 12-week Maintenance Period, a maximum 12-day De-escalation Period for advanced-stage Parkinson's Disease and 30-day Safety Follow-Up Period. The maximum study duration for an individual subject with advanced-stage Parkinson's disease was 27 weeks.

Arms: arm 1: Rotigotine, daily doses, treatment group arm 2: Placebo, daily doses, placebo group
Interventions: intervention 1: Rotigotine intervention 2: Placebo Patch intervention 3: L-dopa
Intervention descriptions: intervention 1: Transdermal Patch

Content:

4 mg /24 h (20 cm\^2), 6 mg /24 h (30 cm\^2), 8 mg /24 h (40 cm\^2)

For advanced-stage Parkinson's Disease, subjects received Rotigotine patches in escalating weekly dose (starting with daily doses 4 mg/24 h to 16 mg/24 h) for a maximum 7-week Titration Period, then 12 week maintenance period intervention 2: Transdermal Patch

Size:

20 cm\^2, 30 cm\^2, 40 cm\^2

Subjects randomized to placebo received matching placebo patches intervention 3: Subject must be on a stable dose of L-dopa (either short-acting or sustained release \[in combination with benserazide or carbidopa\]) of at least 200 mg/day, administered in at least 2 intakes, for at least 28 days prior to Baseline.

Protocol documents:
Clinical trial NCT01649791
Conditions: B-cell Chronic Lymphocytic Leukemia Chronic Lymphocytic Leukemia Stage 0 Chronic Lymphocytic Leukemia Stage I Chronic Lymphocytic Leukemia Stage II Chronic Lymphocytic Leukemia
Sponsor: Roswell Park Cancer Institute
Start date: 2010-01-01; Completion date: 2014-10-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This clinical trial studies lenalidomide as chemoprevention in treating patients with high-risk, early stage B-cell chronic lymphocytic leukemia (B-CLL). Chemoprevention is the use of certain drugs to keep cancer from forming. The use of lenalidomide may slow disease progression in patients with early stage B-cell chronic lymphocytic leukemia

Detailed description:
PRIMARY OBJECTIVES:

I. To determine time to progression in patients with high risk CLL.

SECONDARY OBJECTIVES:

I. Overall response rate including (complete remission \[CR\]+partial remission \[PR\]) of lenalidomide.

II. To determine the incidence of immune mediated flare reaction. III. To characterize the toxicity profile of single agent lenalidomide in previously untreated B-CLL.

IV. To correlate expression of B-CLL co-stimulatory ligands and clinical efficacy of lenalidomide in this patient population.

V. To conduct correlative studies.

OUTLINE: Patients receive lenalidomide orally (PO) once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 3 months for 5 years.

Arms: arm 1: Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: lenalidomide intervention 2: laboratory biomarker analysis intervention 3: lymph node biopsy intervention 4: bone marrow aspiration intervention 5: pharmacological study intervention 6: flow cytometry
Intervention descriptions: intervention 1: Given orally intervention 2: Correlative study intervention 3: Correlative study intervention 4: Correlative study intervention 5: Correlative study intervention 6: Correlative study

Protocol documents:
Clinical trial NCT01665950
Conditions: Bipolar Disorder
Sponsor: Massachusetts General Hospital
Start date: 2012-08-01; Completion date: 2014-10-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Aim: To estimate the antidepressant efficacy of simvastatin versus placebo as an adjunct to lithium, valproate, and/or other atypical antipsychotic therapy among individuals with bipolar I disorder in a nonpsychotic major depressive episode.

Hypothesis: Simvastatin will be superior to placebo in improvement of depressive symptoms assessed by the Montgomery-Asberg Depression Rating Scale (MADRS).

Detailed description:
(see brief summary)

Arms: arm 1: Subjects will receive simvastatin in phase 1 (4 weeks) and phase 2 (4 weeks) arm 2: Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the next 4 weeks arm 3: Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the subsequent 4 weeks
Interventions: intervention 1: Simvastatin intervention 2: Placebo
Intervention descriptions: intervention 1: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks. intervention 2: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks.

Protocol documents:
Clinical trial NCT01674725
Conditions: Chronic Hepatitis C Infection
Keywords: Hepatitis C virus Hepatitis C Genotype 1 Hepatitis C Interferon-Free Chronic Hepatitis C Ombitasvir Ribavirin Viekira PAK Dasabuvir Paritaprevir
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2012-08-01; Completion date: 2014-10-01
Enrollment: 187 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1b (HCV GT1b) infection without cirrhosis.

Detailed description:
A randomized, open-label, multicenter study to evaluate the safety and antiviral activity of the combination of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 with and without ribavirin (RBV) in treatment-experienced, noncirrhotic participants with chronic hepatitis C virus genotype 1b (HCV GT1b) infection.

Arms: arm 1: ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks arm 2: ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
Interventions: intervention 1: ABT-450/r/ABT-267, ABT-333 intervention 2: Ribavirin
Intervention descriptions: intervention 1: Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet intervention 2: Tablet

Protocol documents:
Clinical trial NCT01682642
Conditions: Infertility Endometriosis
Keywords: endometriosis pregnancy In Vitro Fertilization (IVF)/Intra Cytoplastic Sperm Injection (ICSI) peritoneal implants embryo quality
Sponsor: AZ Jan Palfijn Gent
Start date: 2012-03-01; Completion date: 2014-10-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this study of endometriosis patients we compare a common treatment of surgical therapy and medical treatment for 3 months (Zoladex) with patients receiving only surgical therapy. In both cases they immediately start In Vitro Fertilization (IVF) treatment.

Detailed description:

Arms: arm 1: After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months. arm 2: Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
Interventions: intervention 1: Zoladex
Intervention descriptions: intervention 1: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment

Protocol documents:
Clinical trial NCT01692691
Conditions: Melanoma Metastatic
Keywords: Melanoma Metastatic
Sponsor: Western Regional Medical Center
Start date: 2012-08-01; Completion date: 2014-10-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether dacarbazine and carmustine at the doses and schedule used in this study will help to increase tumor shrinkage.

Detailed description:
In this phase II trial, patients with stage IV melanoma will be treated with dacarbazine and carmustine commonly used in this cancer, but given using a schedule that might theoretically improve on this combination. Patients on this study will be assessed in terms of toxicity, response rate, median duration of response, median time to disease progression, and median survival.

Arms: arm 1: Dacarbazine IV - Day 1; Carmustine IV - Day 2; Neulasta SC - Day 3
Interventions: intervention 1: Dacarbazine intervention 2: Carmustine intervention 3: Neulasta
Intervention descriptions: intervention 1: Dacarbazine IV - Day 1 intervention 2: Carmustine IV- Day 2 intervention 3: Neulasta SC - Day 3

Protocol documents:
Clinical trial NCT01697319
Conditions: Mucopolysaccharidosis IVA Morquio A Syndrome MPS IVA
Keywords: Mucopolysaccharidosis IVA Type A MPS IVA Type A Mucopolysaccharidosis IVA MPS IVA Morquio A Syndrome Lysosomal Storage Disorder LSD N-acetylgalactosamine-6-sulfatase N-acetylgalactosamine-6-sulfate sulfatase galactose-6-sulfatase GALNS enzyme replacement therapy ERT MOR-006 CPET Limited ambulation Grip/ Pinch
Sponsor: BioMarin Pharmaceutical
Start date: 2012-08-01; Completion date: 2014-10-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate the effect of 2.0 mg/kg/week BMN 110 in a patient population that has limited ambulation, in a period of up to 144 weeks.

Detailed description:
Effect is defined by the following key domains:

* Upper extremity function and dexterity
* Mobility

Arms: arm 1: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for up to 144 weeks.
Interventions: intervention 1: BMN 110
Intervention descriptions: intervention 1: Drug will be delivered through a 4 hour (approximate) IV infusion at a dosage amount of 2.0 mg/kg/week for up to 144 weeks of treatment.

Protocol documents:
Clinical trial NCT01704521
Conditions: Chronic Hepatitis C Hemophilia
Keywords: Hepatitis C HCV Hemophilia
Sponsor: Kenneth Sherman
Start date: 2012-12-01; Completion date: 2014-10-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine viral dynamic responses in subjects with chronic hepatitis C and hemophilia when treated with pegylated interferon + ribavirin and telaprevir.

Detailed description:
Previous clinical trials for treatment of chronic hepatitis C have excluded subjects with hemophilia from participating.

Arms: arm 1: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin arm 2: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegIntereron + Ribavirin
Interventions: intervention 1: PegInterferon intervention 2: Ribavirin intervention 3: Telaprevir
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01715415
Conditions: Chronic Hepatitis C Infection
Keywords: Hepatitis C Treatment-Experienced Null responder Partial Responder Chronic Hepatitis Hepatitis C Genotype 1 Interferon-Free Hepatitis C Virus Relapser Non responder Viekira Pak ombitasvir ribavirin ritonavir paritaprevir dasabuvir
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2012-11-01; Completion date: 2014-10-01
Enrollment: 395 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected treatment-experienced adults.

Detailed description:

Arms: arm 1: Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks arm 2: Double-blind placebo for 12 weeks, followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Interventions: intervention 1: ABT-450/r/ABT-267, ABT-333 intervention 2: Ribavirin intervention 3: Placebo for ABT-450/r/ABT-267 intervention 4: Placebo for ABT-333 intervention 5: Placebo for ribavirin
Intervention descriptions: intervention 1: Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet intervention 2: Capsule (double-blind treatment period), tablet (open-label treatment period) intervention 3: Tablet intervention 4: Tablet intervention 5: Capsule

Protocol documents:
Clinical trial NCT01721161
Conditions: Acute Optic Neuritis
Keywords: Optic Neuritis
Sponsor: Biogen
Start date: 2012-12-01; Completion date: 2014-10-01
Enrollment: 82 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to evaluate the efficacy of BIIB033 in subjects with their first episode of unilateral acute optic neuritis (AON). The secondary objective of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of BIIB033 in this study population.

Detailed description:

Arms: arm 1: Participants will receive BIIB033 once every 4 weeks for 20 weeks (a total of 6 doses). arm 2: Participants will receive Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses).
Interventions: intervention 1: BIIB033 (anti-LINGO-1 mAb) intervention 2: Placebo
Intervention descriptions: intervention 1: 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses). intervention 2: via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)

Protocol documents:
Clinical trial NCT01722318
Conditions: Irritable Bowel Syndrome Characterized by Constipation
Sponsor: Bausch Health Americas, Inc.
Start date: 2012-11-01; Completion date: 2014-10-01
Enrollment: 428 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, 12-week, double-blind, placebo-controlled, dose-ranging study in patients with IBS-C.

Detailed description:
This is a randomized, 12-week, double-blind, placebo-controlled, dose-ranging study in patients with IBS-C. Patients will undergo a Screening Period to determine eligibility. After completing a Screening Visit patients will undergo a 2-week Pre-Treatment assessment using the Interactive Voice Response System (IVRS) during which they will complete daily assessments of bowel movements (BMs), stool consistency (Bristol Stool Form Scale- BSFS), abdominal pain or abdominal discomfort and other symptoms associated with IBS-C. Data from the two-week IVRS Pre-treatment assessment are used to define the patient's baseline from which change will be determined. Patients who meet all entry criteria will be randomized to one of five treatment groups ( 0.3mg,1.0mg,3.0mg,9mg,or Placebo) on Day 1 of the Treatment Period. Patients will take an oral dose of study drug daily (QD) for 12 weeks and continue the daily IVRS diaries (BMs, abdominal pain, other symptoms). On Weeks 2, 4, 8, and 12, patients will return to the clinic to undergo safety and efficacy assessments. For 2 weeks after completing dosing, (i.e., Post-Treatment Period), patients will continue to complete daily IVRS diaries. Patients will then return to the clinical site for a final follow-up visit (End of Study Visit). The planned duration of participation in this study will be approximately 112 days from signing of informed consent through post-treatment or 145 days if 30 day washout of a prohibited concomitant medication or stabilization of a medical condition is required before Pre-Treatment (up to 148 days, with all windows considered).

Arms: arm 1: Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks arm 2: Plecanatide 1.0mg one tablet by mouth daily for 12 weeks arm 3: Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks arm 4: Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks arm 5: Placebo, one tablet by mouth daily for 12 weeks
Interventions: intervention 1: Plecanatide intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01729598
Conditions: Alzheimer's Disease
Keywords: cognitively normal elderly population safety and tolerability
Sponsor: Gregory Jicha, 323-5550
Start date: 2012-04-01; Completion date: 2014-10-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety of administration and effects of valproic acid on clusterin expression in cognitively-intact, healthy, elderly subjects. Clusterin mutations have recently been identified as a risk factor for the development of Alzheimer's Disease and changes in clusterin expression are seen in the elderly who develop Alzheimer's disease irrespective of whether they carry these genetic mutations or not. Valproic acid may prevent or reverse these changes.

Fourteen subjects with normal memory and thinking will participate in this study. Ten of these subjects will receive valproic acid and 4 will receive a "placebo" capsule with no active medicine. Participants will take study medication or placebo for 28 days and be followed for a total 35 days in this trial.

Detailed description:
This is a placebo-controlled, single-center, multiple ascending dose study. Seven healthy volunteers will be enrolled into 2 sequential cohorts, for a total of 14 enrolled subjects. The study will be conducted using two doses of valproate (250 mg PO bid, followed by 500 mg PO bid). At each dose level, 7 cognitively intact normal elderly subjects will be entered into the study with two subjects randomly selected to receive placebo while the other five subjects receive the designated dose of valproate.

Study procedures will include routine assessment of adverse events, safety labs, baseline MRI, physical and neurological exams, and cerebrospinal fluid collection.

Other investigational medication or devices are prohibited during this study.

Arms: arm 1: Valproic acid 250 mg or 500mg by mouth twice daily. arm 2: Placebo capsule by mouth twice daily.
Interventions: intervention 1: Valproic Acid intervention 2: Placebo
Intervention descriptions: intervention 1: generic valproic acid tablets packaged in placebo-matched capsules. intervention 2: Placebo capsule without active study medication in identical capsules as experimental medicine.

Protocol documents: