ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02239510
Conditions: Chronic Idiopathic Constipation
Keywords: constipation bowel habits
Sponsor: TriHealth Inc.
Start date: 2014-09-01; Completion date: 2016-06-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this prospective, randomized, double blind study, the aim is to determine the efficacy of Linaclotide in relation to Senna in relieving the symptoms of chronic idiopathic constipation (CIC). Patients with CIC, (age 18 - 70) will be enrolled in the study and randomized to Senna or Linaclotide. Patients will be asked to complete questionnaires during the study and will be followed for 12 weeks. Main outcomes include number of daily bowel movements and measures from surveys regarding bowel habits, relief, and satisfaction.

Detailed description:
In this prospective, randomized, double blind study, the aim is to determine the efficacy of Linaclotide in relation to Senna in relieving the symptoms of chronic idiopathic constipation (CIC). Our hypothesis is that Senna is not inferior to Linaclotide in the treatment of CIC. Seventy patients aged 18-70 diagnosed with CIC and seen by a gastroenterologist affiliated with TriHealth or a patient of the Faculty Medical Center clinic will be included in the study. After enrollment, subjects will be randomized to receive either Linaclotide or Senna over a 12-week period after a 1 week wash-out period. During th study period, subjects will complete a log to record the number of daily bowel movements. The subjects will also complete 3 validated surveys on a weekly basis: Subject's Global Assessment SGA of Relief, Subject's Global Assessment SGA of Bowel Habit, and SGA of Satisfaction with their Bowel Habit. A research nurse will meet with subjects at the beginning of the study and then at 3 monthly visits to administer the study medication and distribute the surveys. The main outcomes measures are change in # of bowel movements and SGA survey scores.

Arms: arm 1: 1 capsule (50 mg) Senna daily for 12 weeks arm 2: 1 capsule (145 mcg) once daily for 12 weeks
Interventions: intervention 1: Senna intervention 2: Linzess
Intervention descriptions: intervention 1: 1 capsule (50 mg) Senna daily for 12 weeks intervention 2: 1 capsule (145 mcg) of Linzess once daily for 12 weeks

Protocol documents:
Clinical trial NCT02243007
Conditions: Resectable Pancreatic Cancer Pancreatic Ductal Carcinoma
Keywords: Resectable pancreatic cancer Pancreatic Ductal Carcinoma
Sponsor: Massachusetts General Hospital
Start date: 2014-09-01; Completion date: 2016-06-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research study is a Phase II clinical trial, which evaluates a combination of drugs, FOLFIRINOX and Gemcitabine/Nab-Paclitaxel, in the management of participants with resectable pancreatic cancer prior to surgery.

Detailed description:
Patients who fulfill eligibility criteria will be randomized to Arm A or Arm B

* Treatment will be administered on an outpatient basis.
* Upon registration participants will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
* After completion of FOLFIRINOX or Gemcitabine/Nab-paclitaxel, all participants without progressive disease will proceed to radiation therapy with capecitabine .
* Between 2 and 4 weeks after radiation is complete, participants will proceed for surgical resection of pancreatic cancer

Arms: arm 1: Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel

* Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.
* After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.
* Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer arm 2: * Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
* Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.
* After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine
* Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer
Interventions: intervention 1: FOLFIRINOX intervention 2: Gemcitabine/nab-Paclitaxel intervention 3: Radiation therapy intervention 4: Capecitabine
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT02249052
Conditions: Lipoma
Sponsor: Gerut, Zachary, M.D.
Start date: 2014-08-01; Completion date: 2016-06-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether collagenase is effective in reducing the surface area of a subcutaneous benign lipoma.

Detailed description:
This study will evaluate the safety and efficacy of a Food and Drug Administration (FDA) approved drug (XIAFLEX) in the treatment of lipoma (fatty tumors). The fat in the lipoma is like normal fat except that it is enclosed in a balloon-like structure which is made of collagen (fibrous tissue). Treatment of the lipoma with an injection of XIAFLEX (a protein that breaks down collagen fibers) may dissolve the collagen/fibrous strands thereby decreasing the size of the lipoma or removing it. Each subject must have two lipomas; one lipoma to be treated with placebo and one lipoma to be treated with study drug, both to be observed similarly throughout the trial.

Arms: arm 1: single injection of 0.58 mg study drug arm 2: single injection of placebo
Interventions: intervention 1: AA4500 intervention 2: placebo
Intervention descriptions: intervention 1: Subjects must present with 2 lipomas; one to receive AA4500 and one to receive placebo simultaneously intervention 2: Placebo

Protocol documents:
Clinical trial NCT02256345
Conditions: Heart Failure Diastolic Heart Failure
Sponsor: University of Pennsylvania
Start date: 2015-01-01; Completion date: 2016-06-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will be performed to determine the safety, tolerability, and dose-response to inorganic nitrate on exercise capacity in HFpEF. There are two primary goals for this study:

1. Determine the population-specific pharmacokinetics and dose of KNO3 that can be safely given to subjects with HFpEF.
2. Determine if there is a dose-response effect of nitrate supplementation on exercise capacity, evidenced by peak oxygen consumption (peak VO2), and physiologic adaptations to exercise.

Detailed description:
This study randomized subjects to either placebo (n=3) or KNO3 (n=9) given a sequential dosing regimen: 6 mmol twice daily for 1 week followed by dose escalation to 6 mmol thrice daily for 1 week). Although a primary goal of the study was to assess the safety of KNO3 and within-group changes in various end points in KNO3-treated subjects, a small number of placebo-treated (PB, n=3) subjects were included only to assess for any potential training effect on repeated exercise and Kansas City Cardiomyopathy Questionnaire (KCCQ) measurements. Potassium chloride, given in equivalent doses, was used as the PB to account for differences in blood pressure or flow that could be attributed to potassium.

The study was initially designed to be single-blinded to allow the principal investigator to be aware of arm allocation because of potential concerns for methemoglobinemia with drug administration. One investigator, who was the primary investigator responsible for supervising all visits and measurements during the study, remained blinded to treatment allocation throughout the entirety of the study. All physiological and imaging data were analyzed in a double-blind manner.

Arms: arm 1: KNO3 will be given at a dose of 6 mmol twice daily for the first week, increasing to 6 mmol three times daily for the second week if well tolerated arm 2: KCl will be used as a placebo and will be given as 6 mmol twice daily for the first week, increasing to 6 mmol three times daily for the second week if well tolerated
Interventions: intervention 1: KNO3 intervention 2: KCl
Intervention descriptions: intervention 1: Active Comparator intervention 2: Placebo Comparator

Protocol documents:
Clinical trial NCT02263547
Conditions: Teriflunomide Elimination Healthy Volunteers
Keywords: teriflunomide colestipol hcl
Sponsor: Derrick Scott Robertson
Start date: 2015-03-01; Completion date: 2016-06-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objective To determine if colestipol hydrochloride tablets can accelerate the elimination of teriflunomide. Teriflunomide will be administered for 14 days followed by colestipol dosing of 11 days. Total duration of the study is 40 days.

Secondary Objectives To collect information on the pattern of side effects with use of colestipol hydrochloride after teriflunomide administration and to determine the best duration of therapy needed for adequate elimination

Detailed description:
participants will be followed for 40 days to allow for time to administer a loading dose of teriflunomide and observe the elimination of that drug using colestipol hcl.

Arms: arm 1: None
Interventions: intervention 1: teriflunomide intervention 2: Colestipol
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02276560
Conditions: Stage IIIA Non-Small Cell Lung Cancer
Keywords: main tumor ranging from less than 3cm (T1 up to 7cm (T3)
Sponsor: UNC Lineberger Comprehensive Cancer Center
Start date: 2015-01-01; Completion date: 2016-06-01
Enrollment: 1 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to determine whether giving cisplatin and nab-paclitaxel before surgery will reduce the presence of disease in certain areas of the lung at the time of surgery.

Detailed description:
Objectives

To estimate the rate of N2 nodal clearance at time of surgery in patients with NSCLC undergoing treatment with neoadjuvant nab-paclitaxel plus cisplatin and surgery.

Estimate response rate and complete response rate in non-small cell lung cancer (NSCLC) after 3 cycles of neoadjuvant nab-paclitaxel plus cisplatin

Estimate complete pathological response of primary tumor and lymph nodes at the time of surgery in patients with NSCLC undergoing treatment with neoadjuvant nab-paclitaxel plus cisplatin

Estimate disease free survival for all patients who undergo surgery and also stratified by nodal clearance

Patients will be assigned to receive three (3) cycles of cisplatin (mg/m2) and nab-paclitaxel (125 mg/m2). Surgery will then be conducted per standard of care.

Approximately 4-12 weeks after the surgical resection, patients will receive one of three available treatment regimens based on the results of the surgical reports, which include: Two four week cycles of therapy of Cisplatin and Nab-paclitaxel; Four three-week cycles of Cisplatin and Pemetrexed, or four three-week cycles of Cisplatin and Gemcitabine

Thirty (30) days after treatment ends, subjects will be followed for any ongoing serious adverse events, if necessary, and every 3-6 months thereafter for two years.

After the two years of follow-up, subjects will be followed for survival and disease status

Estimate overall survival for entire group and stratified by nodal clearance

To estimate event free survival (EFS)

Estimate time to distant recurrence and time to local recurrence following total study procedures

Arms: arm 1: Neoadjuvant cisplatin (75 mg/m2) D1 and nab-paclitaxel (125 mg/m2) D1, 8, 15, repeat each 28D cycle x 3 and then surgery per standard of care arm 2: Adjuvant cisplatin (75mg/m2) D1, nab-paclitaxel (125 mg/m2)for D1, 8, 15 repeat each 28D x 2 arm 3: Adjuvant cisplatin (75mg/m2) D1, pemetrexed (500mgm2) D1 or; cisplatin (75 mg/m2),Gemcitabine (1000mg/m2) D1, 8 repeat each 21D cycle x 4
Interventions: intervention 1: Neoadjuvant Cisplatin, nab-paclitaxel intervention 2: Adjuvant Cisplatin,nab-paclitaxel intervention 3: Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabine
Intervention descriptions: intervention 1: Cisplatin (75mg/m2) D1, nab-paclitaxel 125 mg/m2) D1, 8, 15; repeat each 28 D cycle x 2 then surgery intervention 2: Cisplatin 75mg/m2 D1,nab-paclitaxel 125mg/m2 D1, 8, 15, repeat each 28D cycle x 2 intervention 3: Cisplatin 75mg/m2 D1 + pemetrexed 500mg/m2 D1 or Gemcitabine 1000 mg/m2 D1, 8 (if SqCC) repeat each 21 D Cycle x 4

Protocol documents:
Clinical trial NCT02299089
Conditions: Acromegaly Neuroendocrine Tumors
Keywords: acromegaly neuroendocrine tumour (NET) carcinoid syndrome octreotide Sandostatin LAR
Sponsor: Camurus AB
Start date: 2015-01-01; Completion date: 2016-06-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase II, open-label multicentre, randomised study to assess the PK, PD, efficacy, and safety of two dosing regimens of CAM2029 in adult patients with acromegaly or a functional, well-differentiated NET, with carcinoid symptoms.

Detailed description:
This is a Phase II, open-label multicentre, randomised study to assess the PK, PD, efficacy, and safety of two dosing regimens of CAM2029 in adult patients with acromegaly or a functional, well-differentiated NET, with carcinoid symptoms, treated for at least 2 months with Sandostatin LAR at doses of 10 mg, 20 mg, or 30 mg before the start of the Sandostatin LAR Last Dose Assessment Phase (Day -28).

Arms: arm 1: CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks arm 2: CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly arm 3: CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks arm 4: CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly
Interventions: intervention 1: octreotide FluidCrystal® injection depot
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02345031
Conditions: Age-Related Hearing Loss
Keywords: hearing loss speech-in-noise
Sponsor: Autifony Therapeutics Limited
Start date: 2015-01-01; Completion date: 2016-06-01
Enrollment: 78 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to demonstrate that the investigational drug AUT00063 is effective and safe in the treatment of age-related hearing loss.

Detailed description:
Reduced activity at certain sites in the brain (called "voltage-gated potassium channels") has been linked to hearing problems, like age-related loss of hearing or tinnitus (a 'ringing' or buzzing noise in the ears).

AUT00063 is an experimental new medicine that enhances the action of these specific channels and so may treat the brain component of these hearing problems.

The main purpose of this study is to try to demonstrate an improvement in a speech-in-noise deficit after 4 weeks of treatment with the study drug versus the placebo (dummy drug which does not contain the drug). Subjects will undergo a safety follow-up after the treatment period.

Safety and efficacy will be determined by looking at a number of assessments (physical examinations, blood sampling, hearing assessments, questionnaires, etc.).

The amount of drug in the blood will also be measured. It is expected that around 70 people (at least 35 in each arm) with age-related hearing loss may take part in the study. The study participants will be recruited at around 13 sites in the USA.

Arms: arm 1: 3 capsules of 200 mg of the investigational drug AUT00063, to take orally once daily with food for 4 weeks arm 2: 3 capsules of placebo, to take orally once daily with food for 4 weeks
Interventions: intervention 1: AUT00063 intervention 2: Placebo
Intervention descriptions: intervention 1: 600 mg, orally, once a day, for 4 weeks intervention 2: orally, once a day, for 4 weeks

Protocol documents:
Clinical trial NCT02367872
Conditions: Renal Impairment Hepatic Impairment
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2015-03-01; Completion date: 2016-06-01
Enrollment: 48 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the effects of renal and hepatic impairment on TAK-272 pharmacokinetics with a single oral administration of TAK-272 in participants with renal or hepatic impairment.

Detailed description:
This study is a phase I, open-label, parallel-group, comparative study to evaluate the effects of renal or hepatic impairment on pharmacokinetics of TAK-272 with a single oral administration of TAK-272 in participants with renal or hepatic impairment as compared with participants with normal renal and hepatic function.

Arms: arm 1: Fasted single oral administration of TAK-272 40 milligram (mg) arm 2: Fasted single oral administration of TAK-272 40 mg arm 3: Fasted single oral administration of TAK-272 40 mg arm 4: Fasted single oral administration of TAK-272 40 mg arm 5: Fasted single oral administration of TAK-272 40 mg arm 6: Fasted single oral administration of TAK-272 40 mg arm 7: Fasted single oral administration of TAK-272 40 mg arm 8: Fasted single oral administration of TAK-272 40 mg
Interventions: intervention 1: TAK-272
Intervention descriptions: intervention 1: TAK-272 tablet

Protocol documents:
Clinical trial NCT02373163
Conditions: Blood Pressure, High
Sponsor: Prevencion
Start date: 2014-09-01; Completion date: 2016-06-01
Enrollment: 166 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is designed to:

1. Assess the response to montherapy with : a thiazide diuretic (HCTZ), a calcium-channel blocker (CCB, amlodipine) and an angiotensin-receptor blocker (telmisartan), among hypertensive subjects who live at sea level, at medium altitude above sea level and at high altitude above sea level.
2. To test whether diferentes exist in the response to therapy among subjects who live at different altitude above sea level
3. To assess the hemodynamic characteristics of hypertension in populations that live at sea level, at medium altitude above sea level, and at high altitude above sea level.

Detailed description:

Arms: arm 1: Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM arm 2: Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM arm 3: Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
Interventions: intervention 1: Hydrochlorothiazide intervention 2: Amlodipine intervention 3: Telmisartan
Intervention descriptions: intervention 1: Arm: Active Comparator: Diuretic Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Calcium-channel blocker Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Angiotensin Receptor Blocker Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM intervention 2: Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM intervention 3: Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM

Protocol documents:
Clinical trial NCT02378038
Conditions: Richter's Transformation
Keywords: PNT2258 Richter's Transformation NHL Non-Hodgkin's Lymphoma Lymphoma DLBCL Diffuse Large B-cell Lymphoma Lymphoma, Large B-cell, Diffuse Lymphoma, Non-Hodgkin Lymphoma, B-cell
Sponsor: Sierra Oncology LLC - a GSK company
Start date: 2015-08-01; Completion date: 2016-06-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. It is a multi-center, single-arm, 2-stage, open-label phase II investigation of PNT2258 to characterize anti-tumor activity and collect safety data on patients with Richter's Transformation.

Detailed description:

Arms: arm 1: PNT2258 will be administered at 120 mg/m2 on days 1-5 of a 21-day cycle for 8 induction cycles followed by continuation phase therapy at a dose of 100 mg/m2 on days 1-4 of a 28-day cycle.
Interventions: intervention 1: PNT2258
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02385266
Conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Keywords: Interstitial cystitis with Painful Bladder Syndrome Urological Chronic Pelvic Pain Syndrome
Sponsor: Northwestern University
Start date: 2013-09-01; Completion date: 2016-06-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of D-Cycloserine versus placebo treatment in reducing pain from urological chronic pelvic pain syndrome (UCPPS).

Detailed description:
This is a double blinded, randomized control trial (RCT) over a 21 week period that aims to evaluate the treatment efficacy of placebo and D-cycloserine(DCS) in men suffering from UCPPS. The brain functional and anatomical properties associated with treatment response will also be examined.

This study will emphasize on comparing, both clinically and by brain imaging, the analgesic response to placebo in both placebo responders and non-responders in addition to a novel treatment (DCS) that targets the brain's pain mechanism for UCPPS.

Subjects will be randomized to 2 arms, in a 1:1 ratio, to a DCS medication group (n=20) and a placebo medication group (n=20). Questionnaire outcomes and brain scans will occur prior to initiating treatment and at the end of the treatment period. The actual visits required are minimized, 9 visits spread out over 21 weeks, as pain, quality of life and pill ingestion timings are collected using a secure study website accessible electronically.

Arms: arm 1: D-cycloserine 200mg/bid and Acetaminophen prn arm 2: Placebo capsules (lactose)/bid and Acetaminophen prn
Interventions: intervention 1: D-Cycloserine intervention 2: Placebo (for D-cycloserine)
Intervention descriptions: intervention 1: Pharmaceutical intervention aimed at altering central nervous system function takes place over 4.5 months with daily use of d-Cycloserine. intervention 2: Lactose filled capsules to mimic DCS 200mg capsules

Protocol documents:
Clinical trial NCT02387762
Conditions: Rheumatoid Arthritis
Keywords: Acalabrutinib
Sponsor: Acerta Pharma BV
Start date: 2015-04-01; Completion date: 2016-06-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background Methotrexate.

Detailed description:
A multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial. The on-treatment period is 4 weeks with weekly visits to the clinic, followed by a 4-week safety follow-up period after the last dose of ACP-196/placebo. The study was to evaluate the safety, PK, PD, and efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background Methotrexate

Arms: arm 1: Oral acalabrutinib 15 mg QD plus a stable dose of methotrexate (MTX) between 7.5 mg and 25 mg per week arm 2: Oral placebo QD plus a stable dose of MTX between 7.5 mg and 25 mg per week
Interventions: intervention 1: acalabrutinib intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: