ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02398188
Conditions: Central Abdominal Bulging
Sponsor: Evofem Inc.
Start date: 2015-04-09; Completion date: 2015-10-29
Enrollment: 793 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-center, randomized, double-blinded, placebo-controlled study evaluating the safety and efficacy of LIPO-202 for the reduction of central abdominal bulging due to subcutaneous fat in non-obese subjects.

Detailed description:

Arms: arm 1: Experimental arm arm 2: Placebo comparator
Interventions: intervention 1: LIPO-202 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02535000
Conditions: Intervertebral Disc Degeneration
Sponsor: Serviço de Anestesiologia de Joinville
Start date: 2014-01-01; Completion date: 2015-10-30
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Duloxetine as an analgesic agent in patients undergoing elective spine surgery: evaluation with fentanyl demand controlled by the patient. The primary objective is to evaluate the efficacy of duloxetine in fentanyl consumption during the postoperative period of patients undergoing elective spine surgery by intervertebral disc degeneration . Secondary endpoints were pain scores and the presence or absence of adverse effects such as headache, nausea, vomiting, itching, dizziness and drowsiness.

Detailed description:
Multimodal analgesia is widely advocated for the control of perioperative pain in an attempt to reduce the use of opioids and their side effects. Duloxetine is a selective inhibitor of serotonin and norepinephrine reuptake with demonstrated efficacy in chronic pain such as painful diabetic neuropathy and postherpetic neuralgia. The primary objective is to evaluate the efficacy of duloxetine in fentanyl consumption during the postoperative period of patients undergoing elective spine surgery by intervertebral disc degeneration . Duloxetine as an analgesic agent in patients undergoing elective spine surgery: evaluation with fentanyl demand controlled by the patient. The primary objective is to evaluate the efficacy of duloxetine in fentanyl consumption during the postoperative period of patients undergoing elective spine surgery by degenerative disc disease. Secondary endpoints were pain scores and the presence or absence of adverse effects such as headache, nausea, vomiting, itching, dizziness and drowsiness.

Arms: arm 1: subjects who will receive one capsule of placebo before the surgery and being repeated the next day arm 2: subjects who will receive one capsule of duloxetine 60 mg before the surgery and being repeated the next day
Interventions: intervention 1: Duloxetine intervention 2: Placebo
Intervention descriptions: intervention 1: duloxetine 60 mg intervention 2: placebo

Protocol documents:
Clinical trial NCT01955473
Conditions: Solid Tumors
Keywords: Solid tumors Sym004 Phase 1
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2013-10-31; Completion date: 2015-10-31
Enrollment: 51 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This trial is to assess the safety and tolerability of Sym004, administered weekly or biweekly as monotherapy in Japanese subjects with advanced solid tumors.This study consisted of two parts, a dose-escalation part ("Part-A") and a dose-expansion part ("Part-B"). In Part-A, Sym004 will be administered weekly or biweekly as monotherapy in Japanese subjects with advanced solid tumors. In Part-B, Sym004 will be administered weekly as monotherapy to Japanese subjects with advanced esophageal squamous cell carcinoma (ESCC) as dose-expansion. A subject will receive Sym004 administration weekly at a dose that will determined to be the MTD or a dose that will lower than the MTD and determined to be appropriate with recommendation by Safety monitoring committee (SMC). The dose going to used in Part-B will be determined after safety confirmation of weekly regimens in Part-A of this trial.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Sym004
Intervention descriptions: intervention 1: Part-A (dose-escalation): Sym004 will be administered intravenously either weekly at 6 to 12 milligram per kilogram (mg/kg) or biweekly at 18 mg/kg from Week 1 until unacceptable toxicity, disease progression, or consent withdrawal. Part-B (dose-expansion): After the maximum tolerated dose (MTD) is determined in Part-A, up to 30 additional subjects will continue to receive treatment in Part-B.

Protocol documents:
Clinical trial NCT01014936
Conditions: Patients With Solid Tumors, Either Refractory to Standard Therapy or for Which no Effective Standard Therapy is Available
Keywords: Phase 1 advanced solid tumors refractory to standard therapy
Sponsor: EMD Serono
Start date: 2009-11-30; Completion date: 2015-10-31
Enrollment: 149 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a an open-label, dose-escalation, first-in-man (FIM) study designed to explore MSC2156119J, in subjects with advanced solid tumors who have not responded to previous therapies or for whom no other therapies are available.

Subjects will be assigned one of the dosing regimens:

* Regimen 1: MSC2156119J once daily for 14 days, followed by 7 days with no treatment (21-day cycle)
* Regimen 2: MSC2156119J three times per week (e.g., Days 1, 3, and 5) for three weeks (21-day cycle)
* Regimen 3: MSC2156119J every day for three weeks (21-day cycle)

Detailed description:

Arms: arm 1: Subjects will be administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1. arm 2: Subjects will be administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2. arm 3: Subjects will be administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
Interventions: intervention 1: MSC2156119J
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02270983
Conditions: Opioid-Induced Constipation
Keywords: Opioid-Induced Constipation Linaclotide Linzess
Sponsor: Forest Laboratories
Start date: 2014-10-31; Completion date: 2015-10-31
Enrollment: 254 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the safety and efficacy of linaclotide for the treatment of opioid-induced constipation (OIC), in adults receiving stable opioid treatment for chronic non-cancer pain that has been present for a minimum of 3 months.

This study included up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients meeting the entry criteria were randomized to 1 of 2 doses of linaclotide or placebo once per day for 8 weeks. This 8-week study assessed the effects of linaclotide on bowel movement frequency, as well as other bowel symptoms of OIC.

Detailed description:

Arms: arm 1: Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast. arm 2: Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast. arm 3: Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast.
Interventions: intervention 1: Linaclotide 145 micrograms intervention 2: Linaclotide 290 micrograms intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Matching placebo

Protocol documents:
Clinical trial NCT02317809
Conditions: Healthy
Keywords: Healthy Pergoveris Bioequivalence Infertility
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2015-01-31; Completion date: 2015-10-31
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Some women cannot have children because they cannot produce enough follicle stimulating hormone (FSH) and luteinising hormone (LH). When this happens the ovaries fail to produce an egg during the menstrual cycle - a condition known as anovulation. Anovulation can be treated by giving replacement FSH and LH. Pergoveris is a medication that contains both FSH and LH. It is used for the treatment of anovulation in women who do not produce enough FSH and LH.

A new, liquid formulation of Pergoveris is being tested in this study. It will be compared with the current freeze-dried marketed formulation to see if the new formulation gets into the blood stream as easily as the current formulation.

This study will involve 38 healthy female subjects and 2 treatment periods and will last for approximately 77 days. Each subject will receive a single dose of the new liquid formulation and a single dose of the current marketed formulation separated by an interval of two weeks in a randomised (by chance) order. Blood samples will be taken at regular intervals over 2 weeks after each dose to measure levels of FSH and LH.

To participate female subjects must have normal ovaries on internal ultrasound scan, a normal result from a cervical smear test, be taking the combined oral contraceptive (OC) pill.

Eligible subjects will have their usual OC pill replaced with another called Marvelon throughout the study. After 14 days subjects will have their levels of FSH and LH checked and if sufficiently reduced will only then proceed to dosing.

Subjects will then receive one of the formulations. An ultrasound scan of the ovaries will be performed 7 days later, and another one 7 days later just before the next dose. Subjects whose ovaries show signs of stimulation will not be given the second dose. The ultrasound scan will be repeated 7 days after the second dose.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Liquid pergoveris intervention 2: Freeze-dried pergoveris
Intervention descriptions: intervention 1: All subjects will be administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period. intervention 2: All subjects will be administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.

Protocol documents:
Clinical trial NCT02443740
Conditions: Healthy
Keywords: First in human Single Ascending Dose Study Safety and Tolerability Pharmacokinetics Plasma Cerebrospinal Fluid
Sponsor: Biogen
Start date: 2015-05-31; Completion date: 2015-10-31
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a First in human (FIH) single ascending dose study to evaluate the safety, tolerability and pharmacokinetics (PKs) of BIIB118 following single oral doses in healthy human subjects

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

Arms: arm 1: Single ascending doses of BIIB118 administered to healthy volunteers in a cross over study design arm 2: Single ascending doses of BIIB118 administered to healthy volunteers in a cross over study design arm 3: Single maximum dose from Part A of BIIB118 administered to healthy volunteers to assess the PK of BIIB118 in CSF
Interventions: intervention 1: BIIB118 intervention 2: BIIB118 intervention 3: BIIB118
Intervention descriptions: intervention 1: Single ascending doses of BIIB118 as extemporaneously prepared solution/suspension, once every 2 week in a cross over study: 3 mg, 30 mg, 200 mg, 800 mg and placebo intervention 2: Single ascending doses of BIIB118 as extemporaneously prepared solution/suspension, once every 2 week in a cross over study: 10 mg, 100 mg, 400 mg, and placebo intervention 3: Single dose (Maximum Tolerated Dose) of BIIB118 as extemporaneously prepared solution/suspension

Protocol documents:
Clinical trial NCT01067339
Conditions: Endothelial Dysfunction
Keywords: coronary endothelial dysfunction coronary vasospasm
Sponsor: Mayo Clinic
Start date: 2010-02-04; Completion date: 2015-11-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
AIM III is a prospective, randomized, double-blinded, placebo controlled trial. The study is directly connected to IRB 08-008161 as a specific aim of the National Institute of Health (NIH) grant. Participants may either consent to and qualify for AIM I and AIM II (IRB 08-008161) or have a cardiac catheterization with acetylcholine testing in the Cardiac Catheterization Laboratory at Mayo Clinic in Rochester, Minnesota to be considered for this study.

Detailed description:
The main goal of AIM III is to assess and quantify the effect of long-term administration of darapladib 160 mg once a day, a selective, reversible, orally active inhibitor of plasma and vascular Lp-PLA2, on coronary endothelial function, progression of coronary atherosclerosis as determined by intravascular ultrasound (IVUS), and atherosclerosis in patients with early atherosclerosis. Patients with evidence of coronary endothelial dysfunction, as determined by intracoronary administration of acetylcholine during angiography and IVUS, will be followed for 6 months during once daily dosing of darapladib. Coronary endothelial function is determined by the changes in coronary artery diameter and coronary blood flow response to the intracoronary administration of acetylcholine and adenosine. The patients will be followed in clinic 6 months. They will have follow-up angiography, assessment of endothelial function, and IVUS during the six month visit.

Arms: arm 1: Subjects randomized to this arm will receive a darapladib tablet, 160 mg, by mouth, once per day for 6 months. arm 2: Subjects randomized to this arm will receive a placebo tablet matching the study drug, once per day for 6 months.
Interventions: intervention 1: darapladib intervention 2: placebo
Intervention descriptions: intervention 1: darapladib, tablet, 160 mg, by mouth, one time daily, 6 month duration intervention 2: placebo, by mouth, once daily for six months

Protocol documents:
Clinical trial NCT01895335
Conditions: Multiple Sclerosis
Sponsor: Sanofi
Start date: 2013-06-01; Completion date: 2015-11-01
Enrollment: 1001 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objective:

To describe efficacy, tolerability and convenience of teriflunomide treatment through the evaluation of Participant Reported Outcomes (PROs).

Secondary Objectives:

To describe disease progression using PROs. To describe clinical outcomes (ie, treated relapses) in teriflunomide treated participant.

To describe the change in cognition in teriflunomide treated participants. To describe safety of teriflunomide in participant treated (based on adverse events reporting).

To describe adherence and persistence to teriflunomide treatment. To describe quality of life, activity and leisure over the period of teriflunomide treatment.

To compare Participant Determined Disease Steps (PDDS) and Expanded Disability Status Scale (EDSS) in assessing Multiple Sclerosis (MS) disease progression.

Detailed description:
The total duration of the study per participant was up to 50 or 54 weeks (if accelerated elimination procedure performed):

Screening: up to 2 weeks Teriflunomide treatment: 48 weeks Accelerated elimination procedure: 4 weeks when performed

An accelerated elimination procedure at any time after discontinuation of teriflunomide treatment was possible and it was particularly recommended for women of child-bearing potential.

Arms: arm 1: Teriflunomide 14 mg or 7 mg according to local labelling once daily (QD) orally for 48 weeks.
Interventions: intervention 1: Teriflunomide
Intervention descriptions: intervention 1: Pharmaceutical form: film-coated tablet; Route of administration: oral

Protocol documents:
Clinical trial NCT01942148
Conditions: Schizophrenia
Keywords: Schizophrenia, Pediatric patients
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2010-08-01; Completion date: 2015-11-01
Enrollment: 68 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to investigate the safety and efficacy of aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over a period of 52 weeks in subjects who complete a short-term treatment study of pediatric patients (aged 13-17 years) with schizophrenia (031-09-003 study).

Detailed description:

Arms: arm 1: Aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over 52 weeks to subjects who complete the 031-09-003 study
Interventions: intervention 1: Aripiprazole
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02090413
Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: multiple sclerosis flushing aspirin
Sponsor: Biogen
Start date: 2014-05-01; Completion date: 2015-11-01
Enrollment: 241 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to evaluate whether 150 mg enteric-coated aspirin (acetylsalicylic acid \[ASA\]) taken twice a day (BID) with dimethyl fumarate (DMF) administration or 75 mg enteric-coated ASA taken once daily in the morning (QAM) with DMF administration reduces the incidence and/or severity of flushing events in subjects with relapsing-remitting multiple sclerosis (RRMS) compared with ASA-placebo administered with DMF in the clinical practice setting.

Secondary objectives of this study are: to evaluate the safety and tolerability of DMF administered with and without enteric-coated ASA in the clinical practice setting; to evaluate the impact of DMF administration on quality of life as measured by the Short Form 36 (SF-36®) and European Quality of Life - 5 Dimensions - 5 Levels (EQ-5D-5L) questionnaires.

Detailed description:

Arms: arm 1: DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48.

ASA 150 mg is taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA is prohibited; between Weeks 9 and 48, ASA is allowed as needed.) arm 2: DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48.

ASA 75 mg is taken in the morning (QAM) and ASA-Placebo is taken in the evening (QPM) from Day 1 through Week 4. (Between Weeks 5 and 8, ASA is prohibited; between Weeks 9 and 48, ASA is allowed as needed.) arm 3: DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48.

ASA-Placebo is taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA is prohibited; between Weeks 9 and 48, ASA is allowed as needed.)
Interventions: intervention 1: dimethyl fumarate intervention 2: acetylsalicylic acid intervention 3: ASA-Placebo
Intervention descriptions: intervention 1: None intervention 2: enteric-coated capsule intervention 3: matched placebo

Protocol documents:
Clinical trial NCT02347761
Conditions: COPD
Keywords: Chronic Obstructive Pulmonary Disease
Sponsor: Sunovion Respiratory Development Inc.
Start date: 2015-02-01; Completion date: 2015-11-01
Enrollment: 653 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a trial of 12 weeks of treatment with nebulized SUN-101 using an Investigational eFlow® Closed System (CS) nebulizer in subjects with chronic obstructive pulmonary disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD 2014) guidelines.

Detailed description:
This is a Phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter, efficacy and safety trial of 12 weeks of treatment with nebulized SUN-101 using an Investigational eFlow® Closed System (CS) nebulizer in approximately 645 subjects with chronic obstructive pulmonary disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD 2014) guidelines.

SUN-101 or placebo will be administered twice daily as an oral inhalation using the investigational eFlow CS nebulizer. Approximately 150 subjects will be enrolled in the substudy (at selected sites only). These subjects will be required to participate in serial spirometry, vital signs, ECGs, and an additional Holter monitor assessment at Visit 6 (Week 12). This subset of subjects will be referred to as the Substudy Population.

Arms: arm 1: SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer arm 2: SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer arm 3: Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer
Interventions: intervention 1: SUN-101 50 mcg BID eFlow (CS) nebulizer intervention 2: SUN-101 25 mcg BID eFlow (CS) nebulizer intervention 3: Placebo BID eFlow Closed System (CS) nebulizer
Intervention descriptions: intervention 1: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer intervention 2: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer intervention 3: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer

Protocol documents:
Clinical trial NCT00091949
Conditions: Stroke Myocardial Infarction Diabetes
Keywords: stroke heart attack diabetes pioglitazone insulin resistance
Sponsor: Yale University
Start date: 2005-02-01; Completion date: 2015-11-01
Enrollment: 3876 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if pioglitazone is effective in preventing future strokes or heart attacks among non-diabetic persons who have had a recent ischemic stroke.

Detailed description:
Among patients throughout the world who experience a transient ischemic attack (TIA)or ischemic stroke, subsequent stroke and heart attack are major causes of death and disability. Within 4 years of the initial TIA or ischemic stroke, 16 percent of patients will have a recurrent stroke and 9 percent will have a heart attack. Prevention of further vascular events, therefore, is critically important to the health of patients with stroke.

The IRIS trial will test a new treatment strategy based on evidence linking insulin resistance to increased risk for stroke and other vascular diseases. Insulin resistance is a condition in which insulin, a normal human hormone, does not work effectively because the body is resistant to its effects. This condition can lead to diabetes and is thought to cause blood vessel disease, including stroke and heart attack, in patients with and without diabetes.

Insulin resistance affects up to 50% of stroke patients and is effectively modified with thiazolidinedione (TZD) drugs used to treat type 2 diabetes. In addition to reducing insulin resistance, these drugs have other favorable effects on blood vessels, reduce blood vessel inflammation, and potentially prevent atherosclerosis. Currently marketed TZDs include rosiglitazone and pioglitazone.

The IRIS is a clinical trial that will enroll 3936 subjects at approximately 170 hospitals in Australia, Canada, Germany, Israel, Italy, the United Kingdom (UK) and the US. After an initial screening blood test, each participant will be randomly assigned to take either pioglitazone or placebo tablets. Recruitment will be completed during 2005-2012, and all participants will be followed for a minimum of 3 years.

Arms: arm 1: pioglitazone arm 2: inactive substance
Interventions: intervention 1: pioglitazone intervention 2: placebo
Intervention descriptions: intervention 1: a thiazolidinedione drug intervention 2: an inactive substance

Protocol documents: