ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02334982
Conditions: Dose Finding Study
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2013-06-01; Completion date: 2014-01-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to characterize the safety and tolerability profile of TAK-137 when administered as a single dose of tablets at escalating dose levels in healthy participants.

Detailed description:
The drug being tested in this study is called TAK-137. TAK-137 is being tested to find a safe and well-tolerated dose. This study looked at safety (lab results and side effects) and pharmacokinetic properties (drug absorption, distribution, metabolism, and excretion) in people who took TAK-137. This study was designed as a single ascending 6 Cohort dose study with planned doses of 2, 5, 15, 50, and 100 mg and Cohort 6 dose to be determined if the maximum tolerated dose (MTD) was not reached. Anticipated enrollment was 48.

This study enrolled 47 participants and consisted of 6 Cohorts. Participants in Cohorts 1, 2, 3, 5 and 6 were randomized to receive a single dose of TAK-137 or placebo after a 10-hour fast. Participants in Cohort 4 were randomized to receive a single dose of TAK-137 or placebo under fasted conditions, followed by a single dose of TAK-137 or placebo under fed conditions 14 days later. Participants in cohort 4 will receive the same dose in both fasted and fed conditions. The starting dose was 2 mg followed by administrations of 5, 10, 0.5 and 20 mg.

This single-center trial was conducted in the United States. For Cohorts 1, 2, 3, 5, and 6 the overall time to participate in this study was up to 42 days. Participants made 4 visits to the clinic including one 5-day period of confinement to the clinic, and were contacted by telephone 14 days after last dose of study drug for a follow-up assessment.

For Cohort 4 the overall time to participate in this study was up to 56 days. Participants made 7 visits to the clinic including two 5-day periods of confinement to the clinic, and were contacted by telephone 14 days after last dose of study drug for a follow-up assessment.

Arms: arm 1: TAK-137 2 mg, tablets, orally, once on Day 1. arm 2: TAK-137 5 mg, tablets, orally, once on Day 1. arm 3: TAK-137 10 mg, tablets, orally, once on Day 1. arm 4: TAK-137 5 mg, tablets, orally, under fasted conditions, once on Day 1 of Period 1, followed by 14 days of follow-up, followed by TAK-137 5 mg, tablets, orally, under fed conditions, once on Day 1 of Period 2. arm 5: TAK-137 0.5 mg, tablets, orally, once on Day 1. arm 6: TAK-137 20 mg, tablets, orally, once on Day 1. arm 7: TAK-137 placebo-matching tablets, orally, once on Day 1.
Interventions: intervention 1: TAK-137 intervention 2: Placebo
Intervention descriptions: intervention 1: TAK-137 tablets intervention 2: TAK-137 placebo-matching tablets

Protocol documents:
Clinical trial NCT02362373
Conditions: Epilepsy Contraception
Keywords: epilepsy contraception drug interaction
Sponsor: Columbia University
Start date: 2011-08-01; Completion date: 2014-01-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators will conduct a prospective, seven-month pilot study to explore pharmacokinetic (PK) and pharmacodynamic (PD) effects among women with epilepsy using the levonorgestrel intrauterine system (LNG IUS) for contraception. The investigators will enroll twenty women with well-controlled epilepsy maintained on stable anti-epileptic drugs (AED) therapy seeking the LNG IUS for contraception. The primary outcomes are AED levels and seizures before and after LNG IUS placement. Secondary outcomes include LNG levels, evidence of ovulation three weeks after insertion (serum progesterone \>3ng/ml), bleeding and spotting, endometrial thickness, continuation, satisfaction and adverse events (removals, expulsions, side effects). The investigators will conduct a baseline month assessment, insertion visit, and follow-up visits at 21 days, three months and six months.

Detailed description:
Study Procedures This pilot study consists of five study visits. Once preliminary eligibility is determined through a telephone screening interview, the first visit is scheduled.

Visit 1 Enrollment/Baseline

* Review Eligibility
* Informed Consent
* Collect Baseline Information
* Vital Signs
* Pregnancy Test
* Complete Physical Exam including Pelvic exam,
* Chlamydia testing, and a Pap test if needed as per ASCCP (American Society for Colposcopy and Cervical Pathology) guidelines
* Receive diary to record any bleeding or spotting
* Receive condoms, if needed, for use until IUS insertion
* Sign release for contact of primary neurologist or epileptologist
* Study MD to contact participant's neurologist to notify of trial participation, and verify type and dose of AEDs

Visit 2 Insertion/4-6 Weeks from Baseline

* Vital Signs
* Pregnancy Test
* Phlebotomy for hormone and AED levels
* Transvaginal ultrasound
* IUS Insertion
* Review and collect completed diary
* Receive new diary

Visit 3/ Follow up 3 Weeks post IUS Insertion

* Vital Signs
* Phlebotomy for hormone and AED levels
* Transvaginal Ultrasound
* Review and collect completed diary
* Receive new diary

Visit 4/Follow up 3 Months post IUS Insertion

* Vital Signs
* Phlebotomy for hormone and AED levels
* Transvaginal ultrasound
* Review and collect completed diary
* Receive new diary
* Acceptability Questionnaire

Visit 5/ Exit 6 Months post IUS insertion

* Vital Signs
* Phlebotomy for hormone and AED levels
* Transvaginal Ultrasound
* Review and collect final completed diary
* Acceptability Questionnaire

Arms: arm 1: all women in the study underwent placement of the levonorgestrel IUS in an open-label fashion, outcomes were compared before and after placement.
Interventions: intervention 1: levonorgestrel IUS
Intervention descriptions: intervention 1: placement of levonorgestrel intrauterine system

Protocol documents:
Clinical trial NCT02412618
Conditions: Induced Abortion
Sponsor: Medstar Health Research Institute
Start date: 2012-09-01; Completion date: 2014-01-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomized double---blinded comparison of same---day mifepristone and misoprostol with misoprostol only for cervical preparation in second---trimester surgical abortion in 100 women at 14 0/7---19 6/7 weeks gestation.

Detailed description:
Women desiring abortion at gestational ages between 14 weeks 0 days and 19 weeks 6 days were randomized to 200-mg mifepristone or identical placebo with 400-mcg misoprostol vaginally 4-6 hours prior to D\&E. Primary outcome was cervical dilation assessed by the largest Hegar dilator accepted without resistance. Secondary outcomes included total procedure time, and patient and provider perceptions. The study was powered to detect a 2-mm difference in cervical dilatation with 48 participants in each arm.

Arms: arm 1: Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once arm 2: Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once
Interventions: intervention 1: Mifepristone intervention 2: Misoprostol intervention 3: Placebo
Intervention descriptions: intervention 1: Progesterone antagonist intervention 2: Prostaglandin E1 intervention 3: Tasteless, odorless, sugar based pill

Protocol documents:
Clinical trial NCT02568345
Conditions: Incomplete Reversal of Neuromuscular Block
Keywords: Dose-Response Relationship Drug Obesity Cyclodextrins
Sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo
Start date: 2013-01-01; Completion date: 2014-01-01
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the minimum effective dose of sugammadex, an antagonist of neuromuscular blockade used during anesthesia practice, in obese patients, considering that sugammadex is indicated in adults with normal weight at a dose of 2 mg/kg but no studies were found with obese patients.

Detailed description:
Prospective study with the sequential design method up-and-down of the biased coin aimed to determine the minimum effective dose in 90% of patients (ED90).

The following doses were chosen: 2.0 mg.kg-1, 2.2 mg.kg-1, 2.4 mg.kg-1, 2.6 mg.kg-1, 2.8 mg.kg-1.

The complete reversal of moderate rocuronium-induced neuromuscular blockade (NMB) considered a T4/T1 ratio ≥ 0.9 with the peripheral nerve stimulator and accelerometer (monitor of sequential electric stimuli) "train-of-four" (TOF).

After induction of general anesthesia and the calibration of the peripheral nerve stimulator and accelerometer, rocuronium 0.6 mg.kg-1 was injected.

Continuous intravenous infusion of the anesthetics propofol and remifentanil, and intermittent bolus of rocuronium were offered throughout the procedure.

Arms: arm 1: Sequential design method up-and-down of the biased coin aimed to determine the minimum effective dose in 90% of patients (ED90).

The following doses were chosen: 2.0 mg/kg, 2.2 mg/kg, 2.4 mg/kg, 2.6 mg/kg, 2.8 mg/kg.
Interventions: intervention 1: sugammadex ED90
Intervention descriptions: intervention 1: The first patient received the dose of 2.4 mg/kg and if there was a negative response, the next patient would be allocated to receive the next higher dose of 2.6 mg/kg.

In case that 2.4 mg/kg did produce a positive response, the next patient would be randomized with 10% of probability to receive the next dose of 2.2 mg/kg or 90% probability to receive the same dose of 2.4 mg/kg.

Protocol documents:
Clinical trial NCT02907268
Conditions: Facial Rhytids
Keywords: botulinum toxin type A, intradermal
Sponsor: ICLS Dermatology & Plastic Surgery
Start date: 2013-09-01; Completion date: 2014-01-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A 16-week single-blind, split-face, randomized study. Each patient served as their own control, receiving onabotulinumtoxinA and abobotulinumtoxinA randomized to either the left or right side of the face. Patients received intradermal BTXA injections at week 0 and intramuscular BTXA injections at week 2. The objective is to examine the effectiveness of intradermal botulinum toxin type A (BTXA) injection in improving skin texture and midface lift while reducing pore size and sebum production, as well as investigate the differences in effectiveness between onabotulinumtoxinA and abobotulinumtoxinA using intradermal and intramuscular injection methods.

Detailed description:

Arms: arm 1: The first treatment group received onabotulinumtoxinA (Botox) on the right side of their face and abobotulinumtoxinA (Dysport) on the left side of their face. Baseline treatment at Week 0 included the intradermal injection of onabotulinumtoxinA on one side of the face and abobotulinumtoxinA on the other. Patients were treated at Week 2 with traditional intramuscular injections consisting of onabotulinumtoxinA on the same side of their face as at Week 0 and abobotulinumtoxinA on the other side. Patients were treated based on individual need, and thus the treatment volumes were not controlled or standardized. arm 2: The second treatment group received abobotulinumtoxinA (Dysport) on the right side of their face and onabotulinumtoxinA (Botox) on the left side of their face. Baseline treatment at Week 0 included the intradermal injection of onabotulinumtoxinA on one side of the face and abobotulinumtoxinA on the other. Patients were treated at Week 2 with traditional intramuscular injections consisting of onabotulinumtoxinA on the same side of their face as at Week 0 and abobotulinumtoxinA on the other side. Patients were treated based on individual need, and thus the treatment volumes were not controlled or standardized.
Interventions: intervention 1: onabotulinumtoxinA intervention 2: abobotulinumtoxinA
Intervention descriptions: intervention 1: OnabotulinumtoxinA (Botox; Allergan) was approved by the FDA in 2002. Intervention administered by study nurse. Intradermal administered in a regular 1 cm2 grid across the cheeks and forehead. Intramuscular administered as per normal practice. intervention 2: AbobotulinumtoxinA (Dysport; Galderma) was approved by the FDA in 2009. Intervention administered by study nurse. Intradermal administered in a regular 1 cm2 grid across the cheeks and forehead. Intramuscular administered as per normal practice.

Protocol documents:
Clinical trial NCT01562041
Conditions: Atherosclerotic Coronary Vascular Disease
Keywords: Cardiovascular disease Exercise Treadmill Test Ranolazine Angina Myocardial ischemia
Sponsor: Novartis Pharmaceuticals
Start date: 2012-03-09; Completion date: 2014-01-02
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study was designed to evaluate the use of ETT electrocardiogram (ECG) indices as biomarkers in the assessment of atherosclerotic coronary vascular disease (ASCVD).

Detailed description:

Arms: arm 1: Participants received ranolazine 500 milligrams (mg), orally, twice daily (b.i.d.) up to 14 days.
Interventions: intervention 1: Ranolazine 500 mg
Intervention descriptions: intervention 1: Ranolazine 500 mg, oral tablet, b.i.d.

Protocol documents:
Clinical trial NCT01989169
Conditions: Healthy
Sponsor: Shire
Start date: 2013-11-26; Completion date: 2014-01-06
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A Study to Evaluate the Pharmacokinetic Interaction Between SSP-004184 and Midazolam in Healthy Adult Subjects

Detailed description:

Arms: arm 1: Administered as a single oral 6 mg dose on Day 1. arm 2: Midazolam (6 mg) + SSP-004184SS (30 mg/kg) concomitantly administered as a single oral dose on Day 1.
Interventions: intervention 1: Midazolam intervention 2: SSP-004184SS
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01351753
Conditions: Obesity Metabolic Syndrome X
Keywords: Obesity Metabolic Syndrome X Hypertension Dyslipidemia Impaired glucose tolerance
Sponsor: University of Iowa
Start date: 2011-03-01; Completion date: 2014-01-09
Enrollment: 136 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Obesity is common (\>30% of US adults), contributes to substantial morbidity and mortality, but is difficult to treat. Partly this is due to the transient, arduous and modest nature of lifestyle interventions. Partly it is due to the limited efficacy and safety problems of existing pharmacotherapy. Only one drug, orlistat, is approved for long-term use in obesity; but its effects on weight are relatively small. There are drugs that have been approved for other diseases but which also reduce weight. One promising approach to treating obesity is combination therapy with orlistat and one or more of these other agents. The investigators propose an innovative approach to developing new therapies for obesity coupling the use of combination therapy with rigorous assessment of cardiovascular safety. Vascular function is a quantitative surrogate clinical endpoint that has been strongly and independently linked to future cardiovascular events.

Our hypothesis is that combination pharmacotherapy will reduce weight and improve vascular function in obese human subjects. The co-primary endpoints will be weight and vascular function.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: Metformin intervention 2: Orlistat intervention 3: Topiramate intervention 4: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: Placebo pills and capsules for metformin, orlistat and topiramate

Protocol documents:
Clinical trial NCT01553747
Conditions: Irritable Bowel Syndrome
Keywords: Irritable bowel syndrome with diarrhea Irritable bowel syndrome Diarrhea predominant irritable bowel syndrome Colonic diseases Colonic diseases, functional Digestive system disease Gastrointestinal disease Intestinal disease Colonic pseudo-obstruction Diarrhea Signs and symptoms, Digestive
Sponsor: Furiex Pharmaceuticals, Inc
Start date: 2012-05-29; Completion date: 2014-01-09
Enrollment: 1146 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy, safety, and tolerability of different doses of eluxadoline (JNJ-27018966) compared with placebo in the treatment of participants with diarrhea-predominant irritable bowel syndrome.

Detailed description:

Arms: arm 1: Eluxadoline 75 mg tablets, orally, twice daily for up to 26 weeks period. arm 2: Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks period. arm 3: Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks period.
Interventions: intervention 1: Eluxadoline intervention 2: Placebo
Intervention descriptions: intervention 1: Oral tablets twice daily intervention 2: Oral tablets twice daily

Protocol documents:
Clinical trial NCT01694433
Conditions: Acne Vulgaris
Sponsor: University of California, Los Angeles
Start date: 2013-02-01; Completion date: 2014-01-09
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to study the effects of topical Vitamin D cream (Calcipotriene, also known as Dovonex) on acne. The information gained from this study may lead to new treatments for acne. In this study, Calcipotriene will be compared with a placebo, a cream that looks like Calcipotriene, but contains no active ingredients.

Detailed description:
This study will be a randomized, double-blinded, parallel group comparison of calcipotriene vs. placebo cream. Patients with acne will use calcipotriene or placebo cream 2x/day for 12 weeks and will be assessed at weeks 0, 2, 4, 8 and 12. Each group will have 24 subjects as calculated by power analysis. Three additional subjects for each group will be recruited for possible dropouts and total of 27 subjects will be recruited for each group. Primary endpoint (lesion count) and secondary endpoint (IGA- Investigator's Global Assessment) will be determined. Lesion counts will be assessed by one of the investigator physicians or nurse practitioner. Adverse effects including irritation, dry skin, inflammation and worsening of the lesions will be noted at each visit. Photographs will be taken to aid in assessing the clinical changes.

Arms: arm 1: The Calcipotriene Cream will be supplied as 1g daily use individual tubes to be used 2x/day (once in the morning and once in the evening) for 12 weeks. arm 2: The Placebo Cream will be supplied as 1g daily use individual tubes to be used 2x/day (once in the morning and once in the evening) for 12 weeks.
Interventions: intervention 1: Calcipotriene intervention 2: Placebo
Intervention descriptions: intervention 1: 1g daily BID intervention 2: 1g daily BID

Protocol documents:
Clinical trial NCT01713530
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2013-02-21; Completion date: 2014-01-09
Enrollment: 274 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Africa, Europe and the United States of America (USA).

The aim of the trial is to compare the difference in change in glycosylated haemoglobin (HbA1c) between insulin degludec/insulin aspart (IDegAsp) and/or oral anti-diabetic drugs (OADs) and insulin degludec (IDeg) plus insulin aspart (IAsp)and/or OADs.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin degludec/insulin aspart intervention 2: insulin degludec intervention 3: insulin aspart
Intervention descriptions: intervention 1: Dose individually adjusted. For subcutaneous (s.c, under the skin) administration twice a day. intervention 2: Dose individually adjusted. For subcutaneous (s.c, under the skin) administration once daily. intervention 3: Dose individually adjusted. For subcutaneous (s.c, under the skin) administration with the main meals 2-4 times daily in accordance with local labelling.

Protocol documents:
Clinical trial NCT01879410
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: GSK573719 lung function salmeterol (SAL) umeclidinium bromide (UMEC) GW642444 Chronic obstructive pulmonary disease Novel Dry Powder Inhaler (NDPI) fluticasone propionate (FP) vilanterol (VI)
Sponsor: GlaxoSmithKline
Start date: 2013-06-13; Completion date: 2014-01-09
Enrollment: 700 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Umeclidinium/vilanterol (UMEC/VI) is a combination product under development that is used for the treatment of airflow obstruction in patients with COPD. Fluticasone propionate/salmeterol (FSC) is an approved drug that is already in use for the treatment of COPD. This is a multicenter, randomized, double-blind, double-dummy, parallel group study to evaluate the efficacy and safety of UMEC/VI 62.5/25 microgram \[mcg\] once daily administered via Novel Dry Powder Inhaler (NDPI) compared with fluticasone propionate /salmeterol (FSC) 250/50 mcg twice-daily when administered via ACCUHALER/DISKUS inhaler over a treatment period of 12 weeks in subjects with COPD. Eligible subjects will be equally randomized to UMEC/VI 62.5/25 mcg or FSC 250/50 mcg for 12 weeks. A safety follow-up assessment will be conducted approximately 7 days after the end of the study treatment.

Detailed description:

Arms: arm 1: Subjects will receive one inhalation of UMEC/VI 62.5/25 mcg once-daily in the morning via the NDPI and one inhalation of placebo in the morning and evening via ACCUHALER/DISKUS inhaler arm 2: Subjects will receive one inhalation of FSC 250/50 mcg in the morning and evening via ACCUHALER/DISKUS inhaler and one inhalation of placebo administered once-daily in the morning via NDPI
Interventions: intervention 1: UMEC/VI Inhalation Powder 62.5/25 mcg via NDPI intervention 2: FSC Inhalation Powder 250/50 mcg via ACCUHALER/DISKUS intervention 3: Placebo DISKUS intervention 4: Placebo NDPI
Intervention descriptions: intervention 1: The drug is administered via NDPI as one inhalation once daily in the morning. NDPI has two strips, each containing 30 blisters of medication. The first strip has UMEC blended with lactose and magnesium stearate in the form of dry white powder with a dosage of 62.5 mcg per blister and the second strip has VI blended with lactose and magnesium stearate in the form of dry white powder with a dosage of 25 mcg per blister. intervention 2: The drug is administered via ACCUHALER/DISKUS inhaler as one inhalation each morning and evening. The inhaler contains a single strip with 60 blisters of medication. The strip has 250 mcg of fluticasone propionate and 50 mcg of salmeterol per blister in the form of dry white powder. intervention 3: Placebo is administered via ACCUHALER/DISKUS inhaler as one inhalation each morning and evening. The inhaler contains 1 strip with 60 blisters of placebo in the form of dry white powder. intervention 4: Placebo is administered via NDPI as one inhalation once daily in the morning. The inhaler contains 2 strips with 30 blisters of placebo per strip in the form of dry white powder.

Protocol documents:
Clinical trial NCT00738582
Conditions: Malignant Pleural Mesothelioma
Sponsor: Morphotek
Start date: 2008-12-31; Completion date: 2014-01-10
Enrollment: 89 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This research is being done to find out if pemetrexed and cisplatin work better when given together with an experimental drug called MORAb-009 in patients with malignant pleural mesothelioma.

Detailed description:

Arms: arm 1: Pemetrexed, Cisplatin and MORAb-009 (Amatuximab)
Interventions: intervention 1: MORAb-009 (Amatuximab) intervention 2: Pemetrexed intervention 3: Cisplatin
Intervention descriptions: intervention 1: MORAb-009 (Amatuximab) by IV on Days 1 and 8 every 21 days for 6 cycles. intervention 2: Pemetrexed 500 mg/m2 on Day 1 of each 21-day cycle for 6 cycles intervention 3: Cisplatin 75 mg/m2 on Day 1 of each 21-day cycle for 6 cycles

Protocol documents: