ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02345772
Conditions: HER2-positive Breast Cancer ER-positive Breast Cancer
Sponsor: Western Regional Medical Center
Start date: 2014-07-01; Completion date: 2015-11-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Hormonal therapy administered before surgery in ER-positive and HER2-positive patients with breast cancer.

Detailed description:
Hormonal therapy with fulvestrant 500 mg to be administered before surgery With docetaxel, Trastuzumab, and pertuzumab to determine pathological complete remission rate at the time of surgery in ER-positive and HER2-positive patients with breast cancer.

Arms: arm 1: Hormonal therapy with fulvestrant 500 mg will be administered intramuscularly on days 1, 15 of the first cycle, and thereafter on day 1 of every 28-day cycle for up to 5 cycles before surgery. Docetaxel (T) 75 mg/m2 every 3 weeks will be given for four cycles. Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent cycles before and after surgery), pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery.
Interventions: intervention 1: fulvestrant 500 mg intervention 2: Docetaxel intervention 3: Trastuzumab (H, 8mg/kg intervention 4: Pertuzumab (P, 840 mg
Intervention descriptions: intervention 1: Hormonal therapy with fulvestrant 500 mg will be administered intramuscularly on days 1, 15 of the first cycle, and thereafter on day 1 of every 28-day cycle for up to 5 cycles before surgery. intervention 2: Docetaxel (T) 75 mg/m2 every 3 weeks will be given for four cycles. intervention 3: Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent cycles before and after surgery), pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery. intervention 4: Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent cycles before and after surgery), pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery.

Protocol documents:
Clinical trial NCT02359903
Conditions: Ankylosing Spondylitis
Sponsor: Biocad
Start date: 2015-02-01; Completion date: 2015-11-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
ASART-1 clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety profile of BCD-055 (infliximab manufactured by JSC BIOCAD, Russia) and Remicade when used as multiple IV infusions for the treatment of ankylosing spondylitis.

Detailed description:
ASART-1 study is the first step of clinical evaluation of infliximab biosimilar manufactured by JSC BIOCAD, Russia.The aim of this study is to establish that BCD-055 is equivalent to Remicade in terms of pharmacokinetics and safety when used by the standard regimen in patients with ankylosing spondylitis (AS).

The study will enroll 90 patients with active AS, who will be randomized into 2 groups (1:1 ratio): patients from the first group will receive BCD-055 IV at a dose 5 mg/kg on week 0, 2, 6, 14 and 22; patients from the second group will receive Remicade at the same regimen.

Arms: arm 1: BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22 arm 2: Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22
Interventions: intervention 1: Infliximab (BCD-055) intervention 2: Infliximab (Remicade)
Intervention descriptions: intervention 1: infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha intervention 2: None

Protocol documents:
Clinical trial NCT02369796
Conditions: Hypogonadotropic Hypogonadism
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2015-02-01; Completion date: 2015-11-01
Enrollment: 15 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effects on serum testosterone after 4 weeks of subcutaneous (SC) dose administration, with different doses and dosing frequencies of TAK-448 to overweight/obese males with hypogonadotropic hypogonadism.

Detailed description:
The drug being tested in this study is called TAK-448. TAK-448 is being tested to treat overweight/obese males with hypogonadotropic hypogonadism. This study will look at the effects of TAK-448 on serum testosterone at different doses and different dosing frequencies.

The study will enroll 15 patients. There will be 5 cohorts and participants will be assigned to cohorts in sequential order. Cohorts will be assigned to the following treatment groups:

* TAK-448 3 µg once weekly
* TAK-448 1 µg once weekly
* TAK-448 0.3 µg once weekly
* TAK-448 0.3 µg twice weekly
* TAK-448 0.1 µg twice weekly

All participants will be administered study drug via SC injection once or twice a week depending on their assigned cohort for four weeks.

This single-center trial will be conducted in the United Kingdom. The overall time to participate in this study is up to 32 days. Participants will make multiple visits to the clinic (depending once-weekly or twice-weekly dosing), and will be contacted by telephone 1 week after last dose of study drug for a follow-up assessment.

Arms: arm 1: TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22. arm 2: TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22. arm 3: TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22. arm 4: TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25. arm 5: TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
Interventions: intervention 1: TAK-448
Intervention descriptions: intervention 1: TAK-448 solution for subcutaneous injection

Protocol documents:
Clinical trial NCT02370537
Conditions: Diabetes Mellitus, Type 2 Exocrine Pancreatic Insufficiency
Keywords: omega-3 carboxylic acid
Sponsor: AstraZeneca
Start date: 2015-03-01; Completion date: 2015-11-01
Enrollment: 490 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is a 2-part open-label, randomized, crossover, multicenter, non-therapeutic Phase II study to investigate the presence of pancreatic exocrine insufficiency (PEI) in patients with Type 2 diabetes mellitus (T2DM), and to investigate the pharmacokinetics (PK) of EPANOVA® (omega-3 carboxylic acids) and omega-3-acid ethyl esters (OMACOR®, Abbott Healthcare Products Ltd) following a single oral dose in patients with different degrees of PEI.

Detailed description:

Arms: arm 1: A single dose of EPANOVA® 4 g (administered as 4 x 1 g capsules) at Visit 4, followed by 10 to 14 days washout, followed by a single dose of OMACOR® 4 g (administered as 4 x 1 g capsules) at Visit 7. arm 2: A single dose of OMACOR® 4 g (administered as 4 x 1 g capsules) at Visit 4, followed by 10 to 14 days washout, followed by a single dose of EPANOVA® 4 g (administered as 4 x 1 g capsules) at Visit 7.
Interventions: intervention 1: Epanova® (omega-3 carboxylic acids) intervention 2: Omacor® (omega-3-acid ethyl esters)
Intervention descriptions: intervention 1: 4 g (administered orally as 4 x 1 g capsules) intervention 2: 4 g (administered orally as 4 x 1 g capsules)

Protocol documents:
Clinical trial NCT02375724
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD
Sponsor: AstraZeneca
Start date: 2015-03-01; Completion date: 2015-11-01
Enrollment: 300 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the present study is to evaluate the effect of aclidinium bromide 400 μg BID compared with placebo on COPD symptoms in a symptomatic patients population with moderate COPD and chronic bronchitis, and particularly assess the effects in cough by using specific tools to assess the occurrence and impact of this relevant COPD symptom.

Detailed description:

Arms: arm 1: Aclidinium Bromide 400 μg twice daily by inhalation arm 2: placebo twice daily by inhalation
Interventions: intervention 1: Aclidinium Bromide intervention 2: Placebo
Intervention descriptions: intervention 1: Inhaled Aclidinium 400 μg twice per day by Eklira Genuair Inhaler intervention 2: Inhaled dose-matched placebo, twice per day by Eklira Genuair Inhaler

Protocol documents:
Clinical trial NCT02397447
Conditions: Diabetes Mellitus Type 2
Keywords: Momordica Charantia Insulin secretion Insulin sensitivity
Sponsor: University of Guadalajara
Start date: 2013-03-01; Completion date: 2015-11-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The hypoglycemic effect of Momordica Charantia has been evaluated in clinical trials in patients with type 2 diabetes mellitus. Important reductions in fasting plasma glucose, glycated hemoglobin (A1C), and fructosamine were observed. It is unknown whether this improvement is due to an improvement in insulin sensitivity and insulin secretion. The purpose of this study is to evaluate the effect of the administration of Momordica Charantia on insulin sensitivity and insulin secretion in patients with type 2 diabetes mellitus.

Detailed description:
A randomized, double-blind, placebo controlled clinical trial is carried out in 24 patients with diagnosis of diabetes mellitus type 2 according to the criteria of the American Diabetes Association. Patients are assigned to two different arms: one group receives Momordica Charantia, 2 capsules with 500 mg twice daily before breakfast and dinner for 90 days or placebo, under the same scheme of treatment.

An oral glucose tolerance test is performed before and after the intervention. Matsuda index, Stumvoll index and Insulinogenic index are calculated to assess insulin sensitivity and insulin secretion.

Other clinical and laboratory parameters that are evaluated include: Body weight, body mass index, waist circumference, blood pressure, body fat percentage, fasting plasma glucose, A1C, creatinine, lipid profile and liver transaminases.

Arms: arm 1: Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days arm 2: Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days
Interventions: intervention 1: Momordica charantia intervention 2: Placebo
Intervention descriptions: intervention 1: Momordica Charantia: 2000 mg per day for three months intervention 2: Placebo: 2000 mg per day for three months

Protocol documents:
Clinical trial NCT02399345
Conditions: Chronic Hepatitis C Virus (HCV Infection Genotype 1)
Keywords: Treatment naive Hepatitis C Genotype 1
Sponsor: AbbVie
Start date: 2015-03-01; Completion date: 2015-11-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label study will evaluate the safety and efficacy of co-formulated ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with sofosbuvir with or without ribavirin administered for either 4 or 6 weeks in treatment naive adults with chronic HCV-genotype 1 infection without cirrhosis

Detailed description:

Arms: arm 1: Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
Interventions: intervention 1: ombitasvir/paritaprevir/ritonavir, dasabuvir intervention 2: sofosbuvir (SOF) intervention 3: ribavirin (RBV)
Intervention descriptions: intervention 1: tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet intervention 2: tablet intervention 3: tablet

Protocol documents:
Clinical trial NCT02412657
Conditions: Pain
Sponsor: Maisonneuve-Rosemont Hospital
Start date: 2014-09-01; Completion date: 2015-11-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Interscalene brachial plexus block provides excellent but time limited analgesia. Intravenous dexamethasone increases the analgesic duration of a single-shot interscalene block with ropivacaine for shoulder arthroscopic surgery. We want to evaluate the effect of two different doses (dexamethasone 10 mg i.v. vs 4 mg i.v. vs placebo) on the analgesic duration of a single-shot inter scalene block. Our study hypothesis is that dexamethasone 4 mg i.v. is equivalent to dexamethasone10 mg i.v. in prolonging the analgesic duration of a single-shot interscalene block with ropivacaine.

Detailed description:
75 patients will be randomly assigned to three groups:

* D10: dexamethasone 10 mg I.V. diluted in normal saline 20cc, immediately after inter scalene block
* D4: dexamethasone 4 mg I.V. diluted in normal saline 20cc, immediately after inter scalene block
* C: control: Normal saline 20cc I.V., immediately after inter scalene block. These patient will be recruited from 3 hospitals, with two surgeons performing the surgeries.

All patients will have their surgery under regional anesthesia only provided by the inter scalene plexus block, with ropivacaine 0.5% 20cc.

In the postoperative period, patients will be given analgesic medication on an as needed basis. They will be instructed to take the first analgesic medication once postoperative shoulder pain has reached \>3/10. They will note the time and day at which this outcome occurs.

Arms: arm 1: Dexamethasone 10 mg diluted with Normal Saline 17,5 mL i.v. (20 mL total) injected slowly during 30 seconds immediately after performing interscalene brachial plexus block arm 2: Dexamethasone 4 mg diluted with Normal Saline 19 mL i.v. (20 mL total) injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block arm 3: Normal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block
Interventions: intervention 1: Dexamethasone intervention 2: Normal Saline
Intervention descriptions: intervention 1: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v. intervention 2: None

Protocol documents:
Clinical trial NCT02430181
Conditions: Chronic Hepatitis D Infection
Sponsor: Eiger BioPharmaceuticals
Start date: 2014-11-01; Completion date: 2015-11-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To Evaluate the Safety and Efficacy of Lonafarnib with and without Ritonavir Boosting in Adults With Genotype 1 Chronic Hepatitis D Virus (HDV) Infection (LOWR-1).

Detailed description:
Chronic delta hepatitis is a serious form of chronic liver disease caused by infection with the hepatitis D virus (HDV), a small RNA virus that requires farnesylation of its major structural protein (HDV antigen) for replication. Twenty-one subjects with chronic delta hepatitis will be randomized to receive one of seven different doses of lonafarnib. Dosing will occur over 4-12 weeks, depending on treatment arm, and during that time, evidence of antiviral response will be assessed by frequent measurements of HDV-RNA. The primary therapeutic endpoint will be an improvement in quantitative serum HDV RNA levels after treatment with lonafarnib therapy. The primary safety endpoint will be the ability to tolerate the drug at the prescribed dose for the treatment duration. Several secondary endpoints will be measured, including side effects, ALT levels, and symptoms. Therapy will be stopped for intolerance to lonafarnib. This study is designed as a phase 2a study assessing the safety, tolerance and antiviral activity of seven dose combinations of lonafarnib with and without ritonavir boosting.

Arms: arm 1: lonafarnib 200 mg BID; n=3 arm 2: lonafarnib 300 mg BID; n=3 arm 3: lonafarnib 100 mg TID; n=3 arm 4: lonafarnib 100 mg BID + PEG IFN-a 180 ug QW; n=3 arm 5: lonafarnib 200 mg BID + PEG IFN-a 180 ug QW; n=3 arm 6: lonafarnib 300 mg BID + PEG IFN-a 180 ug QW; n=2 arm 7: lonafarnib 100 mg BID + ritonavir 100 mg QD; n=3
Interventions: intervention 1: lonafarnib intervention 2: peginterferon alfa-2a intervention 3: ritonavir
Intervention descriptions: intervention 1: antiviral farnesyl transferase inhibitor intervention 2: immunomodulator intervention 3: CYP 3A4 inhibitor, lonafarnib booster

Protocol documents:
Clinical trial NCT02454283
Conditions: Atrial Fibrillation or Flutter
Sponsor: Laguna Pharmaceuticals, Inc.
Start date: 2015-09-01; Completion date: 2015-11-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
LGN-VN-003 is a prospective, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of a single oral dose of vanoxerine for the conversion of subjects with recent onset atrial fibrillation (AF) or atrial flutter (AFL) to normal sinus rhythm. Up to 625 subjects will be randomized in a 2:1 fashion so at least 400 vanoxerine and 200 placebo subjects receive study drug.

Detailed description:

Arms: arm 1: Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose arm 2: identically matching placebo capsules, orally, single-dose
Interventions: intervention 1: Vanoxerine HCl intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02460289
Conditions: Male Pattern of Hair Loss, Androgenic Alopecia
Sponsor: Galderma R&D
Start date: 2015-05-19; Completion date: 2015-11-01
Enrollment: 63 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to characterize the effect of Minoxidil 5% Foam and Botanical Hair Solution Regimen in men with thinning hair and male pattern hair loss/androgenic alopecia (Norwood III \& IV).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Treatment: Minoxidil 5% / Botanical Hair Solution for Men
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02468700
Conditions: Dry Eye
Sponsor: Ocular Therapeutix, Inc.
Start date: 2015-01-01; Completion date: 2015-11-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of dry eye disease

Detailed description:

Arms: arm 1: OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use arm 2: PV (placebo drug delivery vehicle)
Interventions: intervention 1: Dexamethasone intervention 2: Placebo Vehicle
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02475564
Conditions: Endometriosis
Keywords: resveratrol
Sponsor: Hospital de Clinicas de Porto Alegre
Start date: 2015-06-01; Completion date: 2015-11-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to verify whether the use of 40 mg of resveratrol per day associated with monophasic contraceptive pill (levonorgestrel 0.15mg/ethinyl estradiol 0.03mg) reduces pelvic pain at the end of 2 months of treatment, compared to the use of the pill with placebo.

Detailed description:
Endometriosis is a disease that affects 176 million women around the world, and it is present in about 60% of adolescent women with chronic pelvic pain and dysmenorrhea. Some researchers have investigated the antiproliferative effect of resveratrol in endometriosis using animal models and humans. The reduction in the size and activity of the endometriotic implants has been observed with the use of resveratrol. The reduction of pain in patients with endometriosis is an important aspect of the quality of life. The use of a medication with few side effects and the lack of clinical quality trials justify this study, which aims to verify whether the use of 40 mg of resveratrol per day associated with monophasic contraceptive pill reduces pelvic pain at the end of 2 months of treatment, compared to the use of the pill with placebo. This study will be randomized, prospective, double blind with two arms of 22 patients; the CONSORT parameters will be followed. The degree of pain by visual analog scale, prolactin levels (ng / mL) and the carcinoembryonic antigen levels (CA125) (IU / L) will be measured at the begging and at the end of trial. These parameters will be the outcomes.

Arms: arm 1: Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch) arm 2: Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol
Interventions: intervention 1: Placebo intervention 2: Resveratrol
Intervention descriptions: intervention 1: 40mg of starch intervention 2: 40mg of resveratrol (powder)

Protocol documents:
Clinical trial NCT02481947
Conditions: Chronic Idiopathic Constipation
Sponsor: Braintree Laboratories
Start date: 2015-05-01; Completion date: 2015-11-01
Enrollment: 459 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate a daily dose of BLI400 Laxative for safety and efficacy versus lubiprostone in constipated adults.

Detailed description:

Arms: arm 1: 21 gm BLI400 powder arm 2: 24 mcg capsule bid
Interventions: intervention 1: BLI400 Laxative intervention 2: Lubiprostone
Intervention descriptions: intervention 1: 21 gm BLI400 powder intervention 2: 24 mcg capsule bid

Protocol documents:
Clinical trial NCT02484729
Conditions: Safety Tolerability Pharmacokinetics Healthy Subjects
Keywords: AZD9977 Safety Tolerability Pharmacokinetics First-in-human Single Ascending Dose Regional absorption Healthy male subjects
Sponsor: AstraZeneca
Start date: 2015-07-01; Completion date: 2015-11-01
Enrollment: 196 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will be a randomized, single-blind, placebo-controlled first-in-human study in healthy male subjects to assess the safety, tolerability and pharmacokinetics of single ascending doses of AZD9977. In Part B of this study the regional absorption of AZD9977 along the gastro-intestinal tract will be investigated using the IntelliCap® system in a non-randomized, open-label, fixed-sequence design. The study will be performed at a single study centre.

Detailed description:
This study will be a randomized, single-blind, placebo-controlled first-in-human study in healthy male subjects to assess the safety, tolerability and pharmacokinetics of single ascending doses of AZD9977. In Part B of this study the regional absorption of AZD9977 along the gastro-intestinal tract will be investigated using the IntelliCap® system in a non-randomized, open-label, fixed-sequence design with oral solution as reference. The study will be performed at a single study centre.

Arms: arm 1: In Part A up to 10 cohorts with single ascending doses with AZD9977 as oral suspension. In Part B AZD9977 as oral suspension in IntelliCap® capsule arm 2: In Part A up to 10 cohorts with single doses with matching placebo to AZD9977 arm 3: In Part B, of oral solution of AZD9977 will be used as reference
Interventions: intervention 1: AZD9977, oral suspension intervention 2: Placebo, oral suspension intervention 3: AZD9977, oral solution
Intervention descriptions: intervention 1: Single ascending doses of AZD9977 oral suspension (Part A) Single dose of AZD9977 oral suspension in IntelliCap® capsule in regional absorption part (Part B) intervention 2: Matching placebo intervention 3: AZD9977, single dose of oral solution in Part B as reference

Protocol documents: