ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00837577
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-02-05; Completion date: 2010-08-11
Enrollment: 133 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The phase III clinical trial examines the efficacy, safety, and tolerability of the addition of MK0431/ONO-5435 to Japanese patients with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on diet/exercise therapy and voglibose monotherapy

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Comparator: Placebo intervention 2: Sitagliptin intervention 3: Voglibose
Intervention descriptions: intervention 1: Placebo to sitagliptin once daily for 12 weeks (double-blind period) intervention 2: Sitagliptin/Sitagliptin arm only: Sitagliptin 50 mg once daily orally before breakfast for 12 weeks (double-blind period).

Both arms: Sitagliptin 50 mg once daily orally before breakfast for 40 weeks (open-label period). The dose of sitagliptin was increased up to 100 mg for participants who had an inadequate response to sitagliptin 50mg after treatment Week 20. intervention 3: All participants received a stable dose of voglibose, in

accordance with the package insert, throughout the study.

Protocol documents:
Clinical trial NCT00863304
Conditions: Osteoarthritis
Keywords: monoclonal antibody RN624 PF-04383119 nerve growth factor anti-nerve growth factor OA pain arthritis
Sponsor: Pfizer
Start date: 2009-06-09; Completion date: 2010-08-16
Enrollment: 849 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in patients with osteoarthritis

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: tanezumab 10 mg intervention 2: tanezumab 5 mg intervention 3: naproxen intervention 4: placebo
Intervention descriptions: intervention 1: tanezumab 10 mg one dose at weeks 0 and 8 intervention 2: tanezumab 5 mg one dose at weeks 0 and 8 intervention 3: naproxen 1000 mg daily for 16 weeks intervention 4: placebo to match tanezumab and naproxen dosing

Protocol documents:
Clinical trial NCT00726323
Conditions: Carcinoma, Renal Cell
Keywords: c-Met Papillary Renal Cell Carcinoma(PRC) Sporadic papillary renal cell carcinoma, Clear cell renal carcinoma Hereditary papillary renal cell carcinoma,
Sponsor: GlaxoSmithKline
Start date: 2006-06-30; Completion date: 2010-08-18
Enrollment: 74 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This clinical study is being conducted at multiple sites to determine the best confirmed response rate, safety, and tolerability of GSK1363089 treatment in papillary renal cell carcinoma. Papillary renal cell carcinoma may be classified into hereditary and sporadic forms; subjects with either classification will be accepted into this study.

Detailed description:

Arms: arm 1: 240 mg of foretinib on a 5 day on / 9 day off regimen every 14 days. arm 2: 80 mg foretinib on a daily dosing regimen
Interventions: intervention 1: foretinib (formerly GSK1363089 or XL880)
Intervention descriptions: intervention 1: treatment with oral foretinib on one of 2 dosing regimens: 240 mg on a 5 day on / 9 day off schedule every 14 days, or 80 mg on a daily dosing schedule

Protocol documents:
Clinical trial NCT00950950
Conditions: Osteopenia
Keywords: Amgen Postmenopausal Bone Density
Sponsor: Amgen
Start date: 2009-08-18; Completion date: 2010-08-19
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effect of romosozumab on parameters of bone quality of the forearm using peripheral quantitative computed tomography (pQCT) following multiple subcutaneous dose administrations of romosozumab in postmenopausal women with low bone mass.

Detailed description:

Arms: arm 1: Participants were randomized to receive matching placebo administered by subcutaneous injection once every 4 weeks (Q4W) for 3 months. arm 2: Participants were randomized to receive 3 mg/kg romosozumab administered by subcutaneous injection once every 4 weeks (Q4W) for 3 months.
Interventions: intervention 1: Romosozumab intervention 2: Placebo
Intervention descriptions: intervention 1: Administered by subcutaneous injection intervention 2: Administered by subcutaneous injection

Protocol documents:
Clinical trial NCT01009281
Conditions: Crohn's Disease Inflammatory Bowel Disease
Keywords: Crohn's Disease Crohns Bowel disease digestive disorders auto immune diarrhea Inflammatory Bowel Disease (IBD) gastrointestinal diseases digestive system diseases Antibody IL 17 anti IL-17 monoclonal antibody Crohn's Disease (Chron's, CD)
Sponsor: Novartis Pharmaceuticals
Start date: 2009-10-30; Completion date: 2010-08-19
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the safety and tolerability of AIN457 in patients with moderate to severe Crohn's disease who already participated and completed the core trial CAIN457A2202.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: AIN457
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00521404
Conditions: Pancreatic Cancer
Keywords: Pancreatic cancer chemotherapy naive unresectable or metastatic pancreatic cancer CS1008 Gemcitabine Gemzar
Sponsor: Daiichi Sankyo
Start date: 2007-08-15; Completion date: 2010-08-20
Enrollment: 65 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Phase 2 study to determine the efficacy and safety of CS-1008 when given with gemcitabine to subjects with previously untreated and unresectable (unable to be surgically removed) or metastatic (spread to other areas beyond the pancreas) pancreatic cancer.

Detailed description:
Primary Objective:

\- To evaluate the efficacy of CS-1008 administered in combination with gemcitabine to chemotherapy naive subjects with unresectable or metastatic pancreatic cancer, based on the progression-free survival at 16 weeks.

Secondary Objectives:

* To evaluate the efficacy of CS-1008 administered in combination with gemcitabine on overall progression-free survival rate, objective response rate, duration of response, and overall survival.
* To determine the pharmacokinetics of BIP CS-1008 and DSC CS-1008.
* To study potential biomarkers of CS-1008 activity
* To assess possible human anti-human antibody formation after exposure to CS-1008
* To evaluate the safety profile of CS-1008 when administered in combination with gemcitabine to chemotherapy naive subjects with unresectable or metastatic pancreatic cancer.

Arms: arm 1: CS-1008 + gemcitabine
Interventions: intervention 1: CS-1008 (humanized anti-DR5 antibody) intervention 2: gemcitabine
Intervention descriptions: intervention 1: CS-1008: 8mg/kg loading dose followed by 3mg/kg weekly. intervention 2: Gemcitabine - 1000mg/meter sq

Protocol documents:
Clinical trial NCT01050543
Conditions: Neuromuscular Blockade
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-02-01; Completion date: 2010-08-20
Enrollment: 128 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, active-controlled, parallel-group, single-dose, multi-site, safety-assessor blinded study comparing sugammadex to neostigmine for reversal of neuromuscular blockade in Korean subjects undergoing elective surgical procedures under general anesthesia that require rocuronium for neuromuscular blockade. Study medication will be administered at reappearance of T2. Time to recovery will be measured from start of study medication administration to recovery of the T4/T1 ratio of 0.9. The primary hypothesis is that the time to recovery of the T4/T1 ratio of 0.9 is shorter with sugammadex than with neostigmine.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: sugammadex intervention 2: neostigmine
Intervention descriptions: intervention 1: sugammadex 2.0 mg/kg, single intravenous bolus dose administered within 10 seconds into a fast flowing venous infusion intervention 2: neostigmine 50 mcg/kg (total dose not to exceed 5.0 mg) combined with glycopyrrolate 10 mcg/kg, single intravenous bolus dose administered within 10 seconds into a fast flowing venous infusion

Protocol documents:
Clinical trial NCT00972023
Conditions: Breast Cancer
Keywords: triple-negative breast cancer stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer
Sponsor: Barbara Ann Karmanos Cancer Institute
Start date: 2010-02-01; Completion date: 2010-08-22
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Dehydroepiandrosterone (DHEA) may slow the growth of tumor cells and be an effective treatment for women with breast cancer.

PURPOSE: This phase I trial is studying how well DHEA works in treating women undergoing surgery for stage I, stage II, or stage III breast cancer.

Detailed description:
OBJECTIVES:

Primary

* To identify the effect of the adrenal steroid, dehydroepiandrosterone (DHEA), on tumor proliferation in women with estrogen receptor-negative, progesterone receptor-negative, HER2/neu-negative, and androgen receptor (AR)-positive stage I-III adenocarcinoma of the breast.

Secondary

* To study the effect of DHEA on expression of AR in these patients.
* To assess the effect of DHEA on changes in serum estrogen and androgen hormone levels (e.g., estrone, estradiol, testosterone, dihydrotestosterone, DHEA, and DHEA-sulfate) in these patients.
* To assess the toxicity of DHEA in these patients.
* To follow the clinical course of these patients.

OUTLINE: Patients receive oral dehydroepiandrosterone (DHEA) twice daily on days -14 to 0. Patients then undergo surgery on day 1.

Tissue samples are collected at baseline and at the time of surgery for biomarker analysis (androgen receptor, estrogen receptor, progesterone receptor, HER2/neu, Ki-67, and p53) by IHC. Blood samples are collected at baseline and after completion of treatment with DHEA for analysis of serum hormone (e.g., estrone, estradiol, testosterone, dihydrotestosterone, DHEA, and DHEA-sulfate) and cytokine levels.

After completion of study therapy, patients are followed up at 1 week and then every 6 months for 3 years.

Arms: arm 1: Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;
Interventions: intervention 1: DHEA intervention 2: Surgical resection
Intervention descriptions: intervention 1: DHEA administration will begin approxiately 14 days prior to surgery. intervention 2: Surgical procedure of the invasive breast cancer

Protocol documents:
Clinical trial NCT01009580
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2009-11-05; Completion date: 2010-08-23
Enrollment: 447 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia, Europe and Oceania. The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with biphasic insulin aspart 30 in subjects with type 2 diabetes.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin degludec/insulin aspart intervention 2: biphasic insulin aspart 30
Intervention descriptions: intervention 1: Injected s.c. (under the skin) with the breakfast meal and main evening meal. The dose were individually adjusted. Subjects continued their pre-trial OADs (oral antidiabetic drug(s)) treatment of Metformin, the specific DPP-4 Inhibitor and Pioglitazone. intervention 2: Injected s.c. (under the skin) with the breakfast meal and main evening meal. The dose were individually adjusted. Subjects continued their pre-trial OADs (oral antidiabetic drug(s)) treatment of Metformin, the specific DPP-4 Inhibitor and Pioglitazone.

Protocol documents:
Clinical trial NCT00550771
Conditions: Breast Neoplasm
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-07-16; Completion date: 2010-08-23
Enrollment: 181 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the incidence of cardiac dysfunction in subjects with human epidermal growth factor receptor 2 (HER2) positive breast cancer treated with either doxorubicin or pegylated liposomal doxorubicin (PLD), both in combination with trastuzumab.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: doxorubicin, cyclophosphamide, paclitaxel, trastuzumab intervention 2: PLD, cyclophosphamide, trastuzumab, paclitaxel
Intervention descriptions: intervention 1: doxorubicin 60 mg/m\^2 IV push + cyclophosphamide 600 mg/m\^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m\^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses) intervention 2: PLD 35 mg/m\^2 IV over 60 minutes + cyclophosphamide 600 mg/m\^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m\^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)

Protocol documents:
Clinical trial NCT00839852
Conditions: Schizophrenia
Sponsor: Forest Laboratories
Start date: 2009-05-31; Completion date: 2010-08-31
Enrollment: 97 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an outpatient study to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with schizophrenia.

Detailed description:

Arms: arm 1: Participants received cariprazine 1.5 mg capsule once, twice or three times a day depending on their response and tolerability
Interventions: intervention 1: Cariprazine
Intervention descriptions: intervention 1: Cariprazine was supplied in capsules.

Protocol documents:
Clinical trial NCT00460031
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate stage III prostate cancer stage IV prostate cancer recurrent prostate cancer
Sponsor: Case Comprehensive Cancer Center
Start date: 2006-09-01; Completion date: 2010-08-31
Enrollment: 34 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as ketoconazole, may stop the adrenal glands from making androgens. Lenalidomide may stop the growth of prostate cancer by blocking blood flow to the tumor. Giving ketoconazole and hydrocortisone together with lenalidomide may be an effective treatment for prostate cancer.

PURPOSE: This phase II trial is studying how well giving ketoconazole and hydrocortisone together with lenalidomide works in treating patients with prostate cancer that did not respond to hormone therapy.

Detailed description:
OBJECTIVES:

Primary

* Determine the objective response frequency in patients with hormone-refractory progressive prostate cancer treated with ketoconazole, hydrocortisone, and lenalidomide.

Secondary

* Determine the effect of this regimen on time to clinical progression in these patients.
* Determine the safety of this regimen in these patients.
* Determine the effects of this regimen on serum cytokines, including tumor necrosis factor-alpha, basic fibroblast growth factor, plasma soluble interleukin (IL)-2 receptor, IL-8, and IL-12, as well as serum vascular endothelial growth factor levels in these patients.
* Determine the co-stimulatory effects of this regimen on dendritic cells and CD4-positive, CD25-positive, T-regulatory cells in these patients.

OUTLINE: This is a nonrandomized, open-label study.

Patients receive oral ketoconazole 3 times daily and oral hydrocortisone twice daily on days 1-28 and oral lenalidomide once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo blood collection periodically during study for evaluation of prostate cancer-specific immune response. Blood samples are assessed by serum analysis, flow cytometry, real-time PCR, and enzyme-linked immunosorbent assay techniques to detect and quantify different cytokines, antiangiogenic markers, dendritic cells, and specific T-regulatory cells.

After completion of study therapy, patients are followed at 30 days.

PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study.

Arms: arm 1: None
Interventions: intervention 1: ketoconazole intervention 2: lenalidomide intervention 3: therapeutic hydrocortisone
Intervention descriptions: intervention 1: 400 tid intervention 2: Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle. intervention 3: 20mg qam 10mg qhs

Protocol documents:
Clinical trial NCT00830063
Conditions: Arthritis Osteoarthritis
Keywords: monoclonal antibody RN624 PF-04383119 nerve growth factor anti-nerve growth factor OA pain
Sponsor: Pfizer
Start date: 2009-05-05; Completion date: 2010-08-31
Enrollment: 832 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in patients with osteoarthritis.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: tanezumab 10 mg intervention 2: tanezumab 5 mg intervention 3: naproxen intervention 4: placebo
Intervention descriptions: intervention 1: tanezumab 10 mg one dose at weeks 0 and 8 intervention 2: tanezumab 5 mg one dose at weeks 0 and 8 intervention 3: naproxen 1000 mg daily for 16 weeks intervention 4: placebo to match tanezumab and naproxen dosing

Protocol documents:
Clinical trial NCT01066052
Conditions: Turner's Syndrome
Keywords: Growth hormone Turner syndrome r-hGH early treatment
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 1992-02-29; Completion date: 2010-08-31
Enrollment: 115 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the efficacy and safety of recombinant human growth hormone (r-hGH) treatment in girls with Turner Syndrome under the age of 4 years. After 4 years of treatment, height in these girls will be compared with an historical control group of untreated girls with Turner Syndrome, matched for age and height at baseline.

Detailed description:

Arms: arm 1: Participants (girls) will receive r-hGH as a subcutaneous injection administered by a parent in the evening. During Years 1-2, the dose of r-hGH received will depend on participants' baseline height standard deviation score (SDS) relative to the general population standard: participants with a height SDS of -2 standard deviation (SD) or lower will receive 0.05 milligrams per kilogram (mg/kg) per day r-hGH and those with a height SDS between -1 and -2 SD will receive 0.035 mg/kg per day r-hGH. After 2 years of treatment, all participants will receive a fixed dose of 0.05 mg/kg per day for a further 2 years. arm 2: This arm will include matching (age and height) historical control participants (girls) with turner syndrome, who were born between 1961 and 1990 and were untreated.
Interventions: intervention 1: r-hGH
Intervention descriptions: intervention 1: Subcutaneous administration.

Protocol documents:
Clinical trial NCT00205777
Conditions: Osteoporosis
Keywords: Osteoporosis Postmenopause
Sponsor: Pfizer
Start date: 2001-12-01; Completion date: 2010-09-01
Enrollment: 7609 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether bazedoxifene acetate is safe and effective in the treatment of osteoporosis in postmenopausal women.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Bazedoxifene Acetate intervention 2: Placebo
Intervention descriptions: intervention 1: BZA 20mg, daily, oral intervention 2: Placebo, daily, oral

Protocol documents:
Clinical trial NCT00478231
Conditions: Acquired Immunodeficiency Syndrome HIV Infection
Keywords: Multicenter Open Label Non-Comparative Safety Study Of Maraviroc Treatment Experienced
Sponsor: ViiV Healthcare
Start date: 2007-07-01; Completion date: 2010-09-01
Enrollment: 209 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To collect safety and tolerability data in a more diverse patient population of patients with HIV/Aids, who have limited therapeutic options.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Maraviroc
Intervention descriptions: intervention 1: Maraviroc should be dosed BID with total dose adjusted according to the other drugs the patient is taking. Maraviroc may be taken with or without food. The subject should only take missed doses if it is not within 6 hours prior to the planned next dose. No dose adjustment of OBT is required due to the presence of maraviroc.

Protocol documents:
Clinical trial NCT00772031
Conditions: Chronic Migraine
Keywords: chronic migraine, migraine prevention, chronic headache
Sponsor: Anne Lindblad
Start date: 2008-10-01; Completion date: 2010-09-01
Enrollment: 191 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the reduction in the number of severe headache days at six months in people with chronic migraine treated with topiramate and propranolol versus those treated with topiramate and a placebo.

Detailed description:
Chronic migraine affects about 2 percent of all adults. Currently there are no effective preventative treatments to deal with this disabling condition. Three randomized, placebo-controlled trials found that topiramate was an effective, safe and generally well-tolerated drug for treating chronic migraine. As a result of these trials, topiramate is becoming the standard treatment among headache specialists. Experts agree that treatment with combinations of preventive agents is required in the majority of individuals with chronic migraine for maximal headache relief. No randomized trials have assessed the value of frequently used combinations of preventive agents for chronic migraine.

The goal of this trial is to determine if adding a second drug to topiramate treatment will further reduce the headache burden for people with this condition. In the study, 250 participants with chronic migraine will be randomized to two groups - treatment with topiramate and propranolol or topiramate and placebo. Participants will be followed for six months.

Arms: arm 1: Participants will receive propranolol and topiramate. arm 2: Participants will receive a placebo and topiramate.
Interventions: intervention 1: propranolol LA intervention 2: topiramate intervention 3: placebo
Intervention descriptions: intervention 1: Propranolol LA up to 240 mg/day intervention 2: Topiramate is an effective, safe and generally well-tolerated drug used for treating chronic migraine. It is becoming the standard treatment among headache specialists. intervention 3: an inactive substance

Protocol documents: