ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01755858
Conditions: Renal Artery Obstruction Hypertension, Renovascular Ischemia Reperfusion Injury
Keywords: elamipretide
Sponsor: Stealth BioTherapeutics Inc.
Start date: 2012-12-01; Completion date: 2016-05-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a Phase 2a prospective, single center, randomized, double-blind, placebo-controlled study designed to assess the efficacy, pharmacokinetics, safety and tolerability of IV elamipretide for reduction of reperfusion injury in subjects with Atherosclerotic Renal Artery Stenosis (ARAS), who are undergoing percutaneous transluminal angioplasty of the renal artery (PTRA).

Detailed description:
This was a Phase 2a prospective, single center, randomized, double-blind, placebo-controlled study designed to assess the efficacy, pharmacokinetics, safety and tolerability of IV elamipretide for reduction of reperfusion injury in subjects with ARAS, who are undergoing percutaneous transluminal angioplasty of the renal artery (PTRA).

The randomization (1:1 active:placebo) was stratified by a diagnosis of diabetes mellitus. Participants received either 0.05 mg/kg/h elamipretide or matching placebo, administered as an IV infusion at 60 mL/h infused 30 minutes before and continued 3 hours after PTRA of the renal artery. After completion of the PTRA and stenting, subjects were to receive standard treatment.

Arms: arm 1: Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours. arm 2: Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.
Interventions: intervention 1: Bendavia intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01756456
Conditions: Neurotrophic Keratitis Keratitis Corneal Ulcer
Keywords: Keratitis Corneal Ulcer
Sponsor: Dompé Farmaceutici S.p.A
Start date: 2013-01-01; Completion date: 2016-05-01
Enrollment: 174 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is aimed at assessing the safety and the efficacy of two dose regimens of recombinant human nerve growth factor (rhNGF) eye drops solution compared to vehicle for inducing a complete healing of stage 2 (persistent epithelial defect) and 3 (corneal ulcer) neurotrophic keratitis

Detailed description:
The primary objective of this study is to assess the safety and the efficacy of two dose regimens (10 µg/ml or 20 µg/ml 6 times a day) of recombinant human nerve growth factor (rhNGF) eye drops solution compared to vehicle for inducing a complete healing of stage 2 (persistent epithelial defect) and 3 (corneal ulcer) neurotrophic keratitis (NK) as measured by the Reading Center evaluating the clinical pictures of corneal fluorescein staining.

Secondary objectives of the study are to assess the duration of complete healing, improvement in visual acuity and improvement in corneal sensitivity following treatment with rhNGF eye drops solution

This is a combined phase I/II study. The phase I and II segments of the study will be conducted as an 8 week, randomized, double-masked, vehicle controlled, parallel group study (referred to as the controlled treatment period) followed by a 48 or 56 week follow-up period The design of the phase I and phase II segments of the study are identical with the exception that in the phase I segment of the study the randomization scheme is different and patients will be followed with additional safety assessments and blood samples for PK (pharmacokinetic) profiling In the ascending dose Phase I segment of the study two doses of rhNGF 10 and 20 µg/ml will be evaluated in a sequential manner

Arms: arm 1: active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35μg of rhNGF). arm 2: active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF) arm 3: vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period arm 4: active treatment with rhNGF 10 μg/ml. One drop six times a day (one 35 μl drop equals to 0.35 μg of rhNGF) arm 5: active treatment with rhNGF 20 μg/ml. One drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF) arm 6: vehicle control arm. Ophthalmic solution of the same composition as the test product with the exception of rhNGF. One drop six times a day for the entire period
Interventions: intervention 1: rhNGF 10 μg/ml intervention 2: rhNGF 20 μg/ml intervention 3: vehicle
Intervention descriptions: intervention 1: rhNGF 10 μg/ml : one drop 6 times a day (one 35 μl drop equals to 0.35 μg of rhNGF) intervention 2: one drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF) intervention 3: ophthalmic solution of the same composition as the test product without rhNGF

Protocol documents:
Clinical trial NCT01781234
Conditions: Tobacco Abstinence Syndrome
Sponsor: Ajna Hamidovic
Start date: 2013-08-01; Completion date: 2016-05-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate safety and efficacy of intranasal insulin in abstinent smokers. Groups' (placebo vs. insulin) cognitive function and stress response will be compared.

Detailed description:

Arms: arm 1: Intranasal Insulin arm 2: Placebo
Interventions: intervention 1: Intranasal Insulin intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01846871
Conditions: Glioblastoma
Sponsor: Massachusetts General Hospital
Start date: 2013-06-01; Completion date: 2016-05-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the study drug tivozanib is still being studied. It also means that the FDA has not yet approved tivozanib for your type of cancer.

Tivozanib is an anti-angiogenesis medicine that fights different types of cancer by blocking the blood supply to the tumor, so that the tumor does not receive the nutrients it requires to grow.

In this research study, we are looking to see what effects, good and bad, tivozanib will have on you and your disease.

Detailed description:
If you are willing to participate in this study, you will be asked to undergo some screening tests and procedures that confirm you are eligible. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out taht you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. The screening process may include the following: a medical history, mini-mental status exam, physical exam, performance status, electrocardiogram, blood tests, urine test. If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in this research study.

If you take part in this research study, you will be given a study drug-dosing calendar for each treatment cycle. Each treatment cycle lasts 28 days (4 weeks) during which time you will be taking the study drug once daily for 3 weeks and then no study drug for the last week of each cycle. The diary will also include special instructions for taking the study drug.

During all cycles you will have a physical exam and you will be asked questions about your general health and specific questions about any problems that you might be having and any medications you may be taking.

Standard contrast-enhanced (CE) MRI scans will be done prior to all odd-numbered study cycles. Vascular MRI scans will be done prior to start of treatment, Day 1 of treatment and prior to all even-numbered cycles. These studies will be done in the Charlestown Navy Yard.

We would like to keep track of your medical condition for up to 24 months after your last dose of study treatment. We would like to do this by calling you on the telephone once a year to see how you are doing. Keeping in touch with you and checking your condition every year helps us look at the long-term effects of the research study.

Arms: arm 1: 1.5 mg daily for 3 weeks, with 1 week off.
Interventions: intervention 1: Tivozanib
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01893411
Conditions: Lower Limb Spasticity Due to Cerebral Palsy
Sponsor: Merz Pharmaceuticals GmbH
Start date: 2013-06-01; Completion date: 2016-05-01
Enrollment: 311 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg(s) are effective in treating children/adolescents (age 2-17 years) with increased muscle tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: IncobotulinumtoxinA (16 Units per kg body weight) intervention 2: IncobotulinumtoxinA (12 Units per kg body weight) intervention 3: IncobotulinumtoxinA (4 Units per kg body weight)
Intervention descriptions: intervention 1: Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl); Total volume 8.0 mL; 400 units; Mode of administration: intramuscular injection into spastic muscles. intervention 2: Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl); Total volume 8.0 mL; 300 units; Mode of administration: intramuscular injection into spastic muscles. intervention 3: Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl); Total volume 8.0 mL; 100 units; Mode of administration: intramuscular injection into spastic muscles.

Protocol documents:
Clinical trial NCT01901588
Conditions: Strabismus Delirium on Emergence Pediatric Disorders
Keywords: strabismus pediatric emergence delirium precedex/dexmedetomidine
Sponsor: NYU Langone Health
Start date: 2012-03-01; Completion date: 2016-05-01
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is trying to see if using precedex pre-operatively prevents emergence delirium in pediatric (ages 1-7) patients undergoing strabismus surgery.

Detailed description:
Emergence delirium (ED) is a complex behavioral disturbance characterized by psychomotor agitation, perceptual disturbances, delusions, and disorientation during recovery from general anesthesia. In the population of subjects who undergo strabismus surgery, there are multiple factors that may increase the risk of ED. These include age, typically preschool children aged 1-7 years, rapid surgical times with rapid awakening, use of sevoflurane as the primary anesthetic, and surgically-induced postoperative visual disturbance. The aims of this study are: 1) To examine whether post-induction treatment with an α-2 receptor agonist, precedex (dexmedetomidine), decreases postoperative emergence agitation after strabismus surgery compared to placebo, and 2) to determine whether treatment has any effect on postoperative pain, nausea/vomiting, number of pain-related interventions, and time to PACU discharge. We hypothesize that precedex will attenuate the ED response greater than placebo or a lower dose after strabismus surgery and will reduce PACU pain scores without increasing PACU length of stay.

Inclusion:

i. Pediatric patients aged 1-7 years of age ii. American Society of Anesthesiologists (ASA) physical status I-II iii. No significant laboratory abnormalities

Exclusion:

i. Presence of medicated behavioral disorder ii. Subjects for which precedex, opiates, benzodiazepines, or inhalational anesthetics are contraindicated iii. Parental refusal

Arms: arm 1: dexmedetomidine/precedex arm 2: patients receive saline solution.
Interventions: intervention 1: Dexmedetomidine intervention 2: Placebo
Intervention descriptions: intervention 1: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes intervention 2: intraoperative dose of intravenous placebo

Protocol documents:
Clinical trial NCT01904279
Conditions: Juvenile Idiopathic Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2013-07-01; Completion date: 2016-05-01
Enrollment: 52 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This open-label, multicenter study evaluated the pharmacokinetics, pharmacodynamics and safety of SC administered TCZ in participants with pJIA.

Detailed description:

Arms: arm 1: Participants with body weight less than (\<) 30 kilograms (kg) will be administered 162 milligrams (mg) of TCZ as a SC injection every 3 weeks (Q3W) for 52 weeks. arm 2: Participants with body weight greater than or equal to (\>/=) 30 kg will be administered 162 mg of TCZ as a SC injection every 2 weeks (Q2W) for 52 weeks.
Interventions: intervention 1: Tocilizumab
Intervention descriptions: intervention 1: Participants will receive 162 mg of TCZ as SC injection Q3W or Q2W for 52 weeks

Protocol documents:
Clinical trial NCT01980524
Conditions: Type 2 Diabetes
Sponsor: Medical University of Vienna
Start date: 2013-10-01; Completion date: 2016-05-01
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
There is evidence that inhibition of FFA-release by acipimox is associated with a significant decrease in myocardial lipid content (MYCL) as well as the ejection fraction (as a marker of systolic left ventricular function) in healthy subjects, indicating, that the heart is dependent on a constant supply of free fatty acids in order to guarantee normal cardiac function, and it further indicates, that the heart is not able to cover its energy demand by switching to glucose oxidation.

Since that phenomenon, better known as "metabolic inflexibility" has been mainly described in patients with diabetes, we aim to investigate the impact of FFA-inhibition on MYCL and cardiac function in patients with overt type 2 diabetes.

Detailed description:

Arms: arm 1: 250 mg at 0 and 180 minutes (one day) arm 2: 1 Tablet at 0 and 180 minutes (one day)
Interventions: intervention 1: acipimox intervention 2: Placebo Oral Capsule
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02001688
Conditions: Alpha-1 Antitrypsin Deficiency
Sponsor: Kamada, Ltd.
Start date: 2014-04-01; Completion date: 2016-05-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate different doses of "Kamada-AAT for Inhalation" on the levels of alpha 1-proteinase inhibitor and other analytes in epithelial lining fluid (ELF) and serum and to assess the safety of the treatment in subjects with AAT Deficiency.

Detailed description:

Arms: arm 1: Daily inhalation of Kamada-AAT for Inhalation, 80mg arm 2: Placebo administered by inhalation daily arm 3: Daily inhalation of Kamada-AAT for Inhalation, 160mg
Interventions: intervention 1: Kamada-AAT for Inhalation, 80mg intervention 2: Placebo intervention 3: Kamada-AAT for Inhalation, 160mg
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02026687
Conditions: Gynecological Cancer
Sponsor: Lena Nilsson
Start date: 2014-03-01; Completion date: 2016-05-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare epidural analgesia and intrathecal analgesia for explorative laparotomy through a middle-line incision for gynecological cancer in a fast track program to se if there is any difference in recovery. Length of stay is analyzed together with self-rate quality of life.

Detailed description:

Arms: arm 1: The epidural anesthesia is applied at a low thoracic level, primarily Th10-Th11. A bolus dose of fentanyl together with a continuous infusion of bupivacain 2.5 mg/ml, fentanyl 1.8 µg/ml and epinephrine 2.5 µg/ml is used during surgery. Infusion rate is chosen by the attending anesthetist. Postoperatively the epidural anesthesia is continued until the morning of the third postoperative day using bupivacain 1 mg/ml, fentanyl 2 µg/ml and epinephrine 2µg/ml. Infusion rate is set by the responsible physician, maximum rate is 10 ml/hour. arm 2: The patient is given one intrathecal dose of plain bupivacaine (Marcain® spinal) 5 mg/ml, 15 mg together with morphine (Morphine Special®) 0,4 mg/ml, 0.2 mg and clonidine (Catapresan®) 150 µg/ml, 75 µg. The intrathecal mixture is given through a lumbal puncture at level L2/3, L3/4 or L4/5 before the induction of general anesthesia.
Interventions: intervention 1: Epidural intervention 2: Intrathecal
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02028871
Conditions: Tobacco Abstinence Syndrome
Sponsor: Ajna Hamidovic
Start date: 2014-07-01; Completion date: 2016-05-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This FDA-approved (IND# 120700) study will evaluate efficacy of intranasal insulin in reducing snack intake and reducing postprandial free fatty acid levels in abstinent smokers.

Detailed description:

Arms: arm 1: Intranasal Insulin First, Placebo Second arm 2: Placebo First, Intranasal Insulin Second
Interventions: intervention 1: Intranasal Insulin intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02047500
Conditions: Pancreatic Cancer
Keywords: TH-302 Nab-paclitaxel Gemcitabine Evofosfamide
Sponsor: ImmunoGenesis
Start date: 2014-01-01; Completion date: 2016-05-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multicenter, open-label, Phase 1, dose escalation trial to evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of TH-302 in combination with gemcitabine and nab-paclitaxel in previously untreated subjects with locally advanced unresectable or metastatic pancreatic adenocarcinoma.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: TH-302 intervention 2: Nab-paclitaxel intervention 3: Gemcitabine
Intervention descriptions: intervention 1: TH-302 will be administered at a dose ranging from 170-340 milligram per square meter (mg/m\^2) as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal. intervention 2: Nab-paclitaxel will be administered at a dose ranging from 100-125 mg/m\^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal. intervention 3: Gemcitabine will be administered at a dose ranging from 800-1000 mg/m\^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.

Protocol documents:
Clinical trial NCT02055638
Conditions: Intermittent Explosive Disorder
Keywords: Intermittent Explosive Disorder IED Aggression SRX246 Vasopressin 1a Receptor Antagonist V1a
Sponsor: Azevan Pharmaceuticals
Start date: 2014-05-01; Completion date: 2016-05-01
Enrollment: 97 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to explore the safety and tolerability, and to compare the activity of SRX246 against placebo, in adults with Intermittent Explosive Disorder (IED).

Adult Male and Female subjects with a current diagnosis of IED will be enrolled. After a two-week baseline lead-in phase, study subjects who continue to meet enrollment criteria will be randomized to either SRX246 or Placebo treatment groups.

Study subjects will be examined and asked to answer questionnaires at weekly scheduled visits throughout the trial. The study results will be determined based on any changes observed over the study period.

Detailed description:
This exploratory Phase II study has been designed to examine the safety and tolerability profile, and to compare the activity of the novel V1a vasopressin antagonist (SRX246) against placebo, in adults with DSM-5 Intermittent Explosive Disorder (IED).

Adult Male and Female subjects with a current DSM-5 diagnosis of IED will be enrolled. All subjects will undergo systematic diagnostic assessment for DSM-5 Axis I and II disorders. Subjects with DSM-5 IED (without current, co-morbid, DSM-5 Major Depression) whose: (a) Life History of Aggression (LHA) score is \> 12, (b) Overt Aggression Scale Modified (OAS-M) "Irritability" score is \> 6 and, (c) screening OAS-M "Aggression" score is \> 15, will be entered into a two-week baseline lead-in phase.

After the lead-in phase, study subjects who continue to meet OAS-M criteria will be randomized to one of the two (2) treatment conditions and stratified by gender so that equal numbers of males and females are assigned to SRX246 and Placebo Groups. Those who do not meet the criteria will exit the protocol at that time. Treatment Conditions: (a) 8-week course of SRX246 (4 weeks at 120 mg bid, and 4 weeks at 160 mg bid) or (b) 8-week course of Placebo, followed by a one-week "taper" to withdraw subjects from study medication.

IED subjects in all conditions will have structured diagnostic interview sessions and questionnaires administered throughout the trial. Blinding to treatment condition will be maintained by using different personnel for these activities. Analysis of a change from baseline in the diagnostic measures will be performed.

Arms: arm 1: SRX246 capsules, 120mg bid for 4 weeks followed by 160mg bid for 4 weeks arm 2: Placebo capsules to match the amount of SRX246 capsules for 8 weeks
Interventions: intervention 1: SRX246 intervention 2: Placebo
Intervention descriptions: intervention 1: capsules intervention 2: None

Protocol documents:
Clinical trial NCT02115750
Conditions: Rheumatoid Arthritis
Keywords: CHS-0214 Enbrel RA Biosimilar Etanercept
Sponsor: Coherus Biosciences, Inc.
Start date: 2014-05-01; Completion date: 2016-05-01
Enrollment: 647 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a two part study comparing CHS-0214 to Enbrel in patients with active rheumatoid arthritis and an inadequate response with Methotrexate (MTX) who are naive to biologic therapies.

Pt.1 is a 24-week randomized, double-blind, active-control, parallel-group, multi-center global study. The primary end point is 20% improvement in American College of Rheumatology criteria (ACR-20) at week 24. Comparing CHS-0214 to Enbrel for efficacy and safety.

Pt. 2 is an open-label single arm study in which patients with at least an ACR-20 response receive CHS-0214. Continued response and safety will be evaluated.

Detailed description:

Arms: arm 1: Enbrel 50mg weekly times 24 weeks. arm 2: CHS-0214 50mg weekly times 24 weeks.
Interventions: intervention 1: Etanercept intervention 2: CHS-0214
Intervention descriptions: intervention 1: Head-to-head comparison intervention 2: None

Protocol documents: