ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01116401
Conditions: Menopause Depression Hot Flashes
Keywords: Hot Flashes Sleep disturbance Lupron Menopause
Sponsor: Massachusetts General Hospital
Start date: 2009-11-03; Completion date: 2012-01-04
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
We plan to enroll premenopausal women in a trial investigating the impact of hot flashes developed in response to an injection of a gonadotropin-releasing hormone agonist (GnRHa), leuprolide (brand name: Lupron), on sleep disruption and mood. This study is designed to mimic the menopause transition. We will collect data on sleep disruption and mood changes to assess their relationship to the development of hot flashes.

Detailed description:

Arms: arm 1: We will be administering an injection of leuprolide acetate (a GnRH agonist) to all participants.
Interventions: intervention 1: leuprolide
Intervention descriptions: intervention 1: Leuprolide acetate is a widely used GnRH agonist. In this protocol, leuprolide will be administered at a dose routinely used for treatment of endometriosis and uterine fibroids in women (one 3.75-mg intramuscular injection).

Protocol documents:
Clinical trial NCT00066573
Conditions: Breast Cancer
Keywords: stage IIIA breast cancer stage I breast cancer stage II breast cancer
Sponsor: NCIC Clinical Trials Group
Start date: 2003-06-06; Completion date: 2012-01-06
Enrollment: 7576 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy, using exemestane or anastrozole, may fight breast cancer by reducing the production of estrogen. It is not yet known whether exemestane is more effective than anastrozole in preventing the recurrence of breast cancer.

PURPOSE: This randomized phase III trial is studying exemestane to see how well it works compared to anastrozole in preventing cancer recurrence in postmenopausal women who have undergone surgery for primary breast cancer.

Detailed description:
OBJECTIVES:

Primary

* Compare the event-free survival of postmenopausal women with receptor-positive primary breast cancer when treated with exemestane vs anastrozole.

Secondary

* Compare the overall survival of patients treated with these regimens.
* Compare the time to distant recurrence in patients treated with these regimens.
* Compare the incidence of new primary contralateral breast cancer in patients treated with these regimens.
* Compare the incidence of all clinical fractures, specifically hip and vertebral fractures, in patients treated with these regimens.
* Compare cardiovascular morbidity and mortality (i.e., significant coronary heart disease, which includes myocardial infarctions and angina requiring percutaneous transluminal coronary angioplasty or coronary artery bypass graft, fatal and nonfatal strokes, and all vascular deaths) in patients treated with these regimens.
* Correlate therapy induced changes in breast density with plasma hormones and growth factors, drug levels of exemestane and anastrozole, genetic variation and breast cancer recurrence or contralateral events in patients treated with these regimens.
* Compare the toxic effects of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to lymph node status at diagnosis (negative vs positive vs unknown), prior adjuvant chemotherapy (yes vs no), and herceptin use (yes vs no). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral exemestane (25 mg) once daily for 5 years.
* Arm II: Patients receive oral anastrozole (1 mg) once daily for 5 years. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months during the first year of study participation and annually thereafter.

PROJECTED ACCRUAL: A total of 6,840 patients will be accrued for this study.

Arms: arm 1: Patients receive oral exemestane (25 mg) once daily for 5 years. arm 2: Patients receive oral anastrozole (1 mg) once daily for 5 years.
Interventions: intervention 1: anastrozole intervention 2: exemestane
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally

Protocol documents:
Clinical trial NCT01343407
Conditions: Asthma
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-04-19; Completion date: 2012-01-09
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This was a 2-part study in participants with allergen-induced asthma. It included a procedural pilot component (Part 1). Part 1 tested the key procedures and timing of Part 2; no study drug was administered during Part 1. Part 2 included a pre-randomization placebo run-in (Period 1) and 3 treatment periods (Periods 2, 3, and 4) during which participants were randomized to receive double-blind placebo, MK-1029 60 mg or MK-1029 500 mg in a crossover design. The treatment periods were followed by a minimum 21-day washout. Part 2 assessed allergen-induced sputum eosinophils and allergen-induced late asthmatic response (LAR) compared to placebo.

Detailed description:

Arms: arm 1: Part 2 - Participants will receive 5 days of double-blind, once-daily MK-1029 60 mg followed by a 21-day washout in Period 2, 3, or 4 in a crossover design arm 2: Part 2 - Participants will receive 5 days of double-blind, once-daily MK-1029 60 mg followed by a 21-day washout in Period 2, 3, or 4 in a crossover design arm 3: Part II - Participants will receive 5 days of double-blind, once-daily MK-1029 60 mg followed by a 21-day washout in Period 2, 3, or 4 in a crossover design
Interventions: intervention 1: MK-1029 10 mg intervention 2: MK-1029 100 mg intervention 3: Placebo for MK-1029 10 mg intervention 4: Placebo for MK-1029 100 mg
Intervention descriptions: intervention 1: Six capsules once daily for 5 days in Period 2, 3, or 4 in a crossover design intervention 2: Five capsules once daily for 5 days in Period 2, 3, or 4 in a crossover design intervention 3: Six capsules once daily for 5 days in Period 1, and the same in Period 2, 3, or 4 in a crossover design." intervention 4: Five capsules once daily for 5 days in Period 2, 3, or 4 in a crossover design

Protocol documents:
Clinical trial NCT00988429
Conditions: Partial Epilepsy
Keywords: Refractory partial epilepsy efficacy eslicarbazepine safety
Sponsor: Bial - Portela C S.A.
Start date: 2008-12-02; Completion date: 2012-01-12
Enrollment: 653 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether Eslicarbazepine acetate (BIA 2-093) is an effective adjunct therapy in the treatment of refractory partial seizures

Detailed description:
The study was designed to include 3 parts; only the first part is described in this report. Part I of the study was an international, randomized, placebo-controlled, double-blind, parallel group, multicenter clinical study conducted in 19 countries at 173 sites in 653 subjects with refractory simple partial or complex partial seizures, with or without secondary generalization. After screening procedures and confirming eligibility, subjects entered Part I of the study, which consisted of 3 periods.

The first period was an 8 week observation baseline period (Week -8 to Week -1) during which subjects were instructed on how to complete the seizure diary. At the end of the 8 week observational baseline period, eligible subjects were randomized in a 1:1:1 allocation ratio to 1 of 3 treatment groups (with a blinded treatment assignment):

* Placebo
* ESL 800 mg QD
* ESL 1200 mg QD Subjects then entered the second period of Part 1, the 2 week, double blind, up titration period (Week 1 to Week 2). During this period, subjects in the ESL 800 mg group received ESL 400 mg QD, subjects in the ESL 1200 mg group received ESL 800 mg QD, and subjects in the placebo group received placebo QD.

Subjects then entered the third period of Part I, the 12 week, double-blind, maintenance period (Week 3 to Week 14) where subjects in the ESL 800 mg group received ESL 800 mg QD, subjects in the ESL 1200 mg group received ESL 1200 mg QD, and subjects in the placebo group received placebo QD.

At the completion of the maintenance period, subjects who did not enter Part II were to be tapered off study drug while maintaining the blind according to the following down titration procedure: subjects on 800 mg were down titrated to 400 mg for a duration of 2 weeks, and subjects on 1200 mg were down titrated to 800 mg for 1 week and then down-titrated to 400 mg for 1 week and subjects in the placebo group received placebo QD for 2 weeks. During Part I, 1 to 2 concomitant AEDs were allowed in this study and were to be kept stable during the course of the study.

Arms: arm 1: tablets arm 2: tablets arm 3: tablets
Interventions: intervention 1: 800 mg QD Eslicarbazepine acetate intervention 2: 1200 mg QD Eslicarbazepine acetate intervention 3: Placebo
Intervention descriptions: intervention 1: Oral, 800 mg QD, 2-week titration period and 12-week maintenance period intervention 2: Oral, 1200 mg QD, 2-week titration followed by 12-week maintenance period intervention 3: Placebo tablet given QD

Protocol documents:
Clinical trial NCT01159912
Conditions: Asthma
Keywords: fluticasone propionate Fluticasone furoate
Sponsor: GlaxoSmithKline
Start date: 2010-06-30; Completion date: 2012-01-16
Enrollment: 350 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomised, double-blind, double-dummy, placebo controlled (with rescue medication), multicenter study to evaluate the efficacy and safety of Fluticasone Furoate inhalation powder in the treatment of persistent asthma in adults and adolescents.

Detailed description:
This is a multi-center, randomized, double-blind, double-dummy, parallel-group study to compare the efficacy and safety of Fluticasone Furoate Inhalation Powder 100mcg once daily and Fluticasone Propionate Inhalation Powder 250mcg twice daily with Placebo. Subjects will participate in the study for up to a maximum of 29 weeks (including screening, treatment and follow-up contact). The primary endpoint consists of change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) FEV1 at the end of the 24 week treatment period. The nominated powered secondary endpoint is the change from baseline in the percentage of rescue-free 24 hour periods during the 24-week treatment period. Safety assessments include adverse events, oropharyngeal examinations, clinical chemistry and urine cortisol excretion. For subjects who have consented for pharmacogenetics, a blood sample will also be taken for pharmacogenetic analysis.

Arms: arm 1: Fluticasone furoate inhalation powder once daily and placebo inhalation powder twice daily for 24 weeks arm 2: Fluticasone propionate inhalation powder twice daily and placebo inhalation powder once daily for 24 weeks arm 3: Placebo inhalation powder twice daily for 24 weeks
Interventions: intervention 1: Fluticasone propionate intervention 2: Fluticasone furoate intervention 3: Placebo
Intervention descriptions: intervention 1: Fluticasone propionate inhalation powder, 250 µg intervention 2: Fluticasone furoate inhalation powder, 100 µg intervention 3: Placebo inhalation powder

Protocol documents:
Clinical trial NCT03287219
Conditions: Colon Staining in Preparation for Colonoscopy
Sponsor: Cosmo Technologies Ltd
Start date: 2011-05-02; Completion date: 2012-01-16
Enrollment: 114 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To describe and evaluate the mucosal staining efficacy of Methylene Blue MMX® tablets after total oral doses of 150 or 200 mg in patients undergoing a full colonoscopy for various reasons.

Detailed description:
Objectives:

To describe and evaluate the mucosal staining efficacy of Methylene Blue MMX® tablets after total oral doses of 150 or 200 mg in patients undergoing a full colonoscopy for various reasons.

Primary end-point(s):

To evaluate the mucosal staining efficacy of Methylene Blue MMX® tablets after total oral doses of 150 or 200 mg.

Secondary end-point(s):

Bowel cleansing quality evaluated according to the validated Boston Bowel Preparation Scale (BBPS) after intake of 150 or 200 mg of Methylene Blue MMX® tablets during the intake of the bowel cleansing preparation.

To collect data about safety and tolerability of Methylene Blue MMX® tablets after administration of single oral doses of 150 or 200 mg.

Methodology:

Open label, staining efficacy exploratory study.

Arms: arm 1: take 6 x 25mg Methylene Blue-MMX tablets equivalent to 150 mg arm 2: take 8 x 25mg Methylene Blue-MMX tablets equivalent to 200 mg
Interventions: intervention 1: Methylene Blue MMX 25 mg modified release tablets
Intervention descriptions: intervention 1: Methylene Blue MMX 25 mg modified release tablets administered with a full dose regimen of a 4-L PEG-based bowel cleansing preparation.

Protocol documents:
Clinical trial NCT01294683
Conditions: Primary Hypercholesterolemia Dyslipidemia
Keywords: Low-density lipoprotein LDL High-density lipoprotein HDL Niacin Lipid modifying therapy Cholesterol High cholesterol Triglycerides Mixed Dyslipidemia
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-02-04; Completion date: 2012-01-17
Enrollment: 977 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is being done to find out if tablets containing extended release (ER) niacin, laropiprant, and simvastatin (ERN/LRPT/SIM) are as effective as tablets containing ER niacin and laropiprant taken with simvastatin tablets (ERN/LRPT + SIM) for lowering high cholesterol and high lipid levels in the blood. The primary hypothesis is that ERN/LRPT/SIM 2 g/40 mg is equivalent to ERN/LRPT 2 g co-administered with simvastatin 40 mg in reducing low-density lipoprotein cholesterol (LDL-C).

Detailed description:

Arms: arm 1: After a 2-week placebo run-in, participants received extended release (ER) niacin/laropiprant (N/LRPT) 1 g/20 mg combination tablet (MK-0524B) once daily for 4 weeks, then ERN/LRPT/Simvastatin (SIM) 2 g/40 mg combination tablet once daily for 8 weeks. Participants then received ERN/LRPT 2 g (MK-0524A) co-administered with SIM 40 mg once daily for 8 weeks. arm 2: After a 2-week placebo run-in, participants received ERN/LRPT 1 g (MK-0524A) co-administered with SIM 20 mg once daily for 4 weeks then received ERN/LRPT 2 g (MK-0524A) co-administered with SIM 40 mg once daily for 8 weeks. Participants then received ERN/LRPT/SIM 2 g/40 mg combination tablets (MK-0524B) once daily for 8 weeks.
Interventions: intervention 1: Simvastatin intervention 2: Extended Release (ER) niacin/laropiprant/simvastatin (N/LRPT/SIM) intervention 3: Extended Release (ER) niacin/laropiprant (N/LRPT) intervention 4: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00816400
Conditions: Cancer
Sponsor: MedImmune LLC
Start date: 2009-03-02; Completion date: 2012-01-19
Enrollment: 49 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Evaluate the safety, tolerability and the tolerated maximum dose of MEDI-575 in adult subjects with advanced solid tumors refractory to standard therapy or for which no standard therapy exists.

Detailed description:

Arms: arm 1: Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days \[QWk\]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred. arm 2: MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred. arm 3: MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred. arm 4: MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred. arm 5: MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred. arm 6: MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days \[Q3Wk\]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred. arm 7: MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred. arm 8: MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred. arm 9: MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
Interventions: intervention 1: MEDI-575
Intervention descriptions: intervention 1: MEDI-575 as an IV infusion

Protocol documents:
Clinical trial NCT01076075
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-06-03; Completion date: 2012-01-19
Enrollment: 427 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate whether the addition of Sitagliptin treatment provides a greater decrease in A1C levels compared to placebo in participants with inadequate glycemic control on sulfonylurea and metformin combination therapy.

Detailed description:

Arms: arm 1: Phase A (Weeks 0-24): placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): placebo to Sitagliptin 100 mg + pioglitazone 30 mg arm 2: Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + placebo to pioglitazone
Interventions: intervention 1: Sitagliptin phosphate intervention 2: Comparator: placebo to pioglitazone intervention 3: Comparator: placebo to Sitagliptin intervention 4: Comparator: pioglitazone intervention 5: Glimepiride or gliclazide intervention 6: Metformin intervention 7: Pioglitazone rescue therapy
Intervention descriptions: intervention 1: Phase A (Weeks 0-24): Sitagliptin 100 mg once a day for 24 weeks; Phase B (Weeks 24-54): Sitagliptin 100 mg once a day for 30 weeks intervention 2: Phase B (Weeks 24-54): placebo to pioglitazone 30 mg once a day for 30 weeks intervention 3: Phase A (Weeks 0-24): placebo to Sitagliptin 100 mg once a day for 24 weeks; Phase B (Weeks 24-54): placebo to Sitagliptin once a day for 30 weeks intervention 4: Phase B (Weeks 24-54): pioglitazone 30 mg once a day for 30 weeks intervention 5: Phase A (Weeks 0-24): stable dose, as prescribed by investigator, of glimepiride or gliclazide; Phase B (Weeks 24-54): stable dose, as prescribed by investigator, of glimepiride or gliclazide intervention 6: Phase A (Weeks 0-24): stable dose, as prescribed

by investigator, of metformin; Phase B (Weeks 24-

54): stable dose, as prescribed by investigator, of

metformin intervention 7: Phase A (Weeks 0-24): participants not meeting specific glycemic goals will receive pioglitazone (open label) at a dose determined by the investigator. These participants will not initiate Phase B (Weeks 24-54) double blind pioglitazone.

Protocol documents:
Clinical trial NCT00068406
Conditions: Stage III Vulvar Cancer Stage IVB Vulvar Cancer Vulvar Squamous Cell Carcinoma
Sponsor: Gynecologic Oncology Group
Start date: 2005-01-01; Completion date: 2012-01-20
Enrollment: 61 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well giving radiation therapy together with cisplatin followed by surgery works in treating patients with locally advanced cancer of the vulva. Drugs used in chemotherapy such as cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy with radiation therapy before surgery may shrink the tumor so it can be removed during surgery.

Detailed description:
OBJECTIVES:

I. Determine the efficacy of radiotherapy and cisplatin, in terms of achieving a complete clinical and pathological response, in patients with locally advanced squamous cell carcinoma of the vulva that is not amenable to standard radical vulvectomy.

II. Determine the toxicity of this regimen followed by surgery in these patients.

OUTLINE: This is a multicenter study.

Patients undergo radiotherapy daily on days 1-5 and receive concurrent cisplatin IV over 30 minutes on day 1. Treatment repeats weekly for approximately 6.5 weeks (a total of 32 fractions of radiotherapy) in the absence of unacceptable toxicity.

Six to eight weeks after the completion of chemoradiotherapy, patients with a complete clinical response may undergo incisional biopsy of the primary tumor and bilateral inguinal/femoral nodes (if the groin nodes were initially unresectable). Patients with microscopic or gross resectable residual disease may then undergo radical resection of the residual tumor. Patients with unresectable disease after the completion of chemoradiotherapy receive additional radiotherapy with 1-2 courses of concurrent cisplatin.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Arms: arm 1: Patients undergo radiotherapy daily on days 1-5 and receive concurrent cisplatin IV over 30 minutes on day 1. Treatment repeats weekly for approximately 6.5 weeks (a total of 32 fractions of radiotherapy) in the absence of unacceptable toxicity.

Six to eight weeks after the completion of chemoradiotherapy, patients with a complete clinical response may undergo incisional biopsy of the primary tumor and bilateral inguinal/femoral nodes (if the groin nodes were initially unresectable). Patients with microscopic or gross resectable residual disease may then undergo radical resection of the residual tumor. Patients with unresectable disease after the completion of chemoradiotherapy receive additional radiotherapy with 1-2 courses of concurrent cisplatin.
Interventions: intervention 1: 3-Dimensional Conformal Radiation Therapy intervention 2: Cisplatin intervention 3: Conventional Surgery
Intervention descriptions: intervention 1: None intervention 2: Given IV intervention 3: None

Protocol documents: