ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01359644
Conditions: Chronic Hepatitis C
Sponsor: Bristol-Myers Squibb
Start date: 2011-06-01; Completion date: 2013-10-01
Enrollment: 350 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine whether therapy with the combination of PSI-7977 and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus (HCV) infection when given for 12 or 24 weeks as measured by sustained virologic response with undetectable HCV RNA 12 weeks post treatment

Detailed description:

Arms: arm 1: Genotype 1a or 1b arm 2: Genotype 2 or 3 arm 3: Genotype 1a or 1b arm 4: Genotype 2 or 3 arm 5: Genotype 1a or 1b arm 6: Genotype 2 or 3 arm 7: Hepatitis C virus genotype 1, treatment-naive patients

Genotype 1a or 1b arm 8: Hepatitis C virus genotype 1, treatment-naive patients

Genotype 1a or 1b arm 9: Patients who experienced telaprevir/boceprevir treatment failure

Genotype 1a or 1b arm 10: Patients who experienced telaprevir/boceprevir treatment failure

Genotype 1a or 1b
Interventions: intervention 1: PSI-7977 intervention 2: Daclatasvir intervention 3: Ribavirin
Intervention descriptions: intervention 1: Tablets, oral, 400 mg, once daily intervention 2: Tablets, oral, 60 mg, once daily intervention 3: Tablets, oral, 200 mg

Protocol documents:
Clinical trial NCT01400139
Conditions: Chronic Nonmalignant and Nonneuropathic Pain
Keywords: Pain Nonmalignant pain Nonneuropathic Pain Opioid
Sponsor: Purdue Pharma LP
Start date: 2011-07-01; Completion date: 2013-10-01
Enrollment: 922 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to characterize the long-term safety of Hydrocodone Bitartrate (HYD) tablets 20 to 120 mg once-daily in subjects with chronic nonmalignant and nonneuropathic pain.

Detailed description:

Arms: arm 1: Hydrocodone bitartrate (HYD) once daily (q24h) tablets
Interventions: intervention 1: Hydrocodone bitartrate q24h film-coated tablets
Intervention descriptions: intervention 1: Hydrocodone bitartrate q24h film-coated tablets 20 - 120 mg once daily

Protocol documents:
Clinical trial NCT01571453
Conditions: Major Depressive Disorder
Keywords: MDD
Sponsor: H. Lundbeck A/S
Start date: 2012-05-01; Completion date: 2013-10-01
Enrollment: 437 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will be conducted with the aim of investigating the efficacy, safety and tolerability of 10 mg/day Vortioxetine in Asian patients compared to an approved active comparator (venlafaxine extended release 150 mg/day).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Vortioxetine (Lu AA21004) intervention 2: Venlafaxine extended release
Intervention descriptions: intervention 1: 10 mg/day intervention 2: 150 mg/day

Protocol documents:
Clinical trial NCT00129389
Conditions: Breast Cancer
Keywords: Node negative, high risk breast cancer. Prognostic gene profile. Saint Gallen high risk criteria. Weekly paclitaxel.
Sponsor: Spanish Breast Cancer Research Group
Start date: 2003-09-19; Completion date: 2013-10-01
Enrollment: 1925 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a prospective, open-label, randomized, phase III trial. Patients will be stratified after breast surgery, as per investigational site; menopausal status; node negative diagnosis, as per sentinel-node technique versus lymphadenectomy; hormone receptor status (positive versus negative).

Detailed description:
Patients will be randomized to:

* Fluorouracil, doxorubicin, and cyclophosphamide (FAC) x 6 (cycles): 5-fluorouracil 500 mg/m2 + doxorubicin 50 mg/m2 + cyclophosphamide 500 mg/m2 day 1, every 3 weeks, for 6 cycles.
* FAC x 4 (cycles) → Paclitaxel x 8 (cycles): 5-fluorouracil 500 mg/m2 + doxorubicin 50 mg/m2 + cyclophosphamide 500 mg/m2 day 1, every 3 weeks, for 4 cycles, followed by 8 administrations of weekly paclitaxel 100 mg/m2

Premenopausal women with hormone receptor positive tumors must receive tamoxifen 20 mg daily for 5 years, after the end of chemotherapy.

Postmenopausal women with hormone receptor positive tumors are allowed to receive aromatase inhibitors as initial adjuvant hormone therapy or after tamoxifen.

All patients with breast conservative surgery must receive radiotherapy.

Estimated 5-year disease-free survival in the control arm (FAC x 6) is expected to be 80%. It is expected that disease-free survival will increase by 5% in the experimental arm (FAC-paclitaxel). 906 patients per arm must be recruited, to detect this difference with an alpha error of 0.05 and 80% power. Assuming a 6% post-randomization drop-out rate, 960 patients per arm are needed, 1920 in total.

Arms: arm 1: FAC X 6 The standard arm consisted of six cycles of FAC (fluorouracil 500 mg/m2, doxorubicin 50mg/m2, and cyclophosphamide 500mg/m2) administered once every 3 weeks. arm 2: FAC X 4 + 8 weekly Paclitaxel (wP) Patients in the experimental arm received four cycles of the FAC regimen followed by eight weekly administrations of paclitaxel (100mg/m2 per dose)
Interventions: intervention 1: Fluorouracil intervention 2: Doxorubicin intervention 3: Cyclophosphamide intervention 4: Paclitaxel
Intervention descriptions: intervention 1: Arm A: FAC Arm B: FAC-wP intervention 2: Arm A: FAC Arm B: FAC-wP intervention 3: Arm A: FAC Arm B: FAC-wP intervention 4: Arm B: FAC-wP

Protocol documents:
Clinical trial NCT00133679
Conditions: Hernia, Diaphragmatic Hypertension, Pulmonary Hypoplasia, Pulmonary
Keywords: Chronic lung disease Nitric oxide cyclic guanosine monophosphate phosphodiesterase inhibitor
Sponsor: University of California, San Francisco
Start date: 2006-02-01; Completion date: 2013-10-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test if sildenafil is effective in the treatment of infants with severe congenital diaphragmatic hernia (determined by the presence of prolonged pulmonary hypertension or prolonged oxygen supplementation on mechanical ventilation), as measured by the estimated pulmonary artery systolic pressure following treatment.

Detailed description:
Congenital diaphragmatic hernia (CDH) is a condition characterized by pulmonary parenchymal and vascular hypoplasia. Severe CDH carries a high rate of mortality, and significant morbidity among survivors. This proposal is a randomized, blinded, placebo-controlled study designed to evaluate the efficacy and potential mechanisms of activity of sildenafil, a phosphodiesterase-5 inhibitor, for treatment of severe CDH. Infants who meet criteria at ≥10d of age predicting a poor outcome \[death or chronic lung disease (CLD) severe enough to require hospital discharge on supplemental oxygen (O2)\] will be eligible for the study. Infants whose parents consent for the study will undergo an initial echocardiogram to assess the degree of pulmonary hypertension. They will then begin either sildenafil or placebo therapy for a 45d course. A final echocardiogram will be performed after the experimental drug course is completed. The pulmonary arterial systolic pressure estimate during hyperoxic conditions will be compared between the sildenafil and placebo groups. Infants from either group who have severely elevated pulmonary arterial pressure (despite supplemental O2) will be considered for open-label sildenafil, which will continue after hospital discharge, depending on the results of a cardiac catheterization performed for clinical care.

Arms: arm 1: Sildenafil x 45 days arm 2: Placebo x 45 d
Interventions: intervention 1: sildenafil intervention 2: Placebo
Intervention descriptions: intervention 1: Sildenafil 0.5 mg/kg every 6 hours orally x 45 d intervention 2: Placebo suspension (equal volume to experimental drug) x 45 days

Protocol documents:
Clinical trial NCT00195039
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Sponsor: Weill Medical College of Cornell University
Start date: 2004-08-01; Completion date: 2013-10-01
Enrollment: 47 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out how effective 177Lu -J591 is in the treatment of patients with metastatic, androgen-independent prostate cancer.

Detailed description:
To determine the clinical activity of 177Lu -J591 for the treatment of patients with metastatic, androgen-independent prostate cancer.

Patients will receive a single dose of J591 (total antibody of 20 mg) consisting of antibody chelated with 177Lu at a dose of 65 or 70 mCi/m2 with a specific activity of 12-15 mCi/mg plus non-radiolabeled antibody.

Arms: arm 1: Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated ("naked") J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.
Interventions: intervention 1: 177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591)
Intervention descriptions: intervention 1: Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated ("naked") J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.

Protocol documents:
Clinical trial NCT00222729
Conditions: Cancer
Keywords: head neck
Sponsor: University of Pittsburgh
Start date: 2005-11-01; Completion date: 2013-10-01
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if the combination of two new drugs pemetrexed (Alimta) and bevacizumab (Avastin) can increase the effectiveness of treatment for head and neck cancer. Currently pemetrexed is approved by the Food and Drug Administration (FDA) for another type of cancer, mesothelioma, but it is not approved for head and neck cancer.

Detailed description:
Main objectives of this study are to 1) evaluate the time to progression (primary endpoint) with the combination of pemetrexed and bevacizumab in recurrent or metastatic head and neck cancer; 2) evaluate the objective response rate, duration of response, overall survival, and toxicities associated with the above therapy and 3) collect tumor tissue from previous diagnostic procedures and blood specimens prospectively, before and after therapy, for future correlative studies.

Arms: arm 1: None
Interventions: intervention 1: Pemetrexed intervention 2: Bevacizumab
Intervention descriptions: intervention 1: 500 mg/m2 day 1 q 21 days intervention 2: 15 mg/kg IV q 21 days following pemetrexed

Protocol documents:
Clinical trial NCT00323869
Conditions: Lung Cancer Non-small Cell Lung Cancer (NSCLC)
Sponsor: Stanford University
Start date: 2006-06-01; Completion date: 2013-10-01
Enrollment: 48 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A multi-center study of bevacizumab in combination with gemcitabine and carboplatin as treatment for newly-diagnosed advanced non-small cell lung cancer (NSCLC).

Detailed description:
This is a open-label, phase 2, single-arm, multi-center study of bevacizumab combined with gemcitabine and carboplatin. This treatment is for newly-diagnosed advanced non-small cell lung cancer (NSCLC), excluding squamous cell carcinoma. All subjects will receive 15 mg/kg bevacizumab every 3 weeks cycle, 1000 mg/m² of gemcitabine on day 1 and 8 every 3 weeks cycle and carboplatin (AUC= 5 ) every 3 weeks. Carboplasm will be administered 1 hour prior to the gemcitabine infusion, bevacizumab will be administered 1 hour following chemotherapy infusion.

Subjects will receive a maximum of 6 cycles of chemotherapy, but treatment with bevacizumab may continue as long as patients have no evidence of progressive disease and no significant treatment-related toxicities.

Arms: arm 1: Bevacizumab in combination with carboplatin and gemcitabine:

•Carboplatin, administered IV at area under the curve (AUC) of 5, every 3 weeks on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles.

Carboplatin was administered before the gemcitabine infusion:

•Gemcitabine, administered 1000 mg/m² IV on days 1 and 8 of each 3-week cycle (twice per cycle) for up to 6 cycles

Bevacizumab was administered 1 hour after end of all chemotherapy infusions:

•Bevacizumab was administered 15 mg/kg IV on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles in combination with chemotherapy, then continuing until evidence of progressive disease or significant treatment-related toxicity
Interventions: intervention 1: Bevacizumab intervention 2: Gemcitabine intervention 3: Carboplatin
Intervention descriptions: intervention 1: Murine humanized anti-vascular endothelial growth factor A (VEGF-A) monoclonal antibody intervention 2: Nucleoside analog intervention 3: Alkylating agent

Protocol documents:
Clinical trial NCT00324155
Conditions: Melanoma
Keywords: Stage IIIc N3 (unresectable) Stage IV melanoma
Sponsor: Bristol-Myers Squibb
Start date: 2006-08-01; Completion date: 2013-10-01
Enrollment: 681 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical research study is to examine the safety and effectiveness (how well the drug works) of two different treatments for patients with melanoma. One treatment is an investigational compound (a drug that is not currently approved by the United States Food and Drug Administration \[FDA\]), know as Ipilimumab (also known as MDX-010 or BMS-734016) together with an approved chemotherapy drug called Dacarbazine

Detailed description:
For the extension phase:

Allocation: single arm study; Masking: open label; Intervention Model: Single Group

Arms: arm 1: In Maintenance phase: Ipilimumab will be continued. Dacarbazine was given up to Week 22 and is not given in the Maintenance phase arm 2: None
Interventions: intervention 1: Ipilimumab intervention 2: Placebo intervention 3: Dacarbazine
Intervention descriptions: intervention 1: Intravenous solution; intravenous; 10mg/kg; one dose every 3 weeks for 10 weeks then one dose every 12 weeks starting at Week 24, until disease progression, unacceptable toxicity or withdrawal of consent

In Maintenance phase: Only Ipilimumab: 10mg/kg, every 12 weeks will be continued until disease progression intervention 2: Intravenous solution; intravenous; 0 mg; one dose every 3 weeks for 10 weeks then one dose every 12 weeks starting at Week 24; until disease progression, unacceptable toxicity or withdrawal of consent intervention 3: Intravenous solution; intravenous; 850 mg/m\^2; one dose every 3 weeks for 22 weeks, until disease progression, unacceptable toxicity or withdrawal of consent

Protocol documents:
Clinical trial NCT00333775
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2006-03-01; Completion date: 2013-10-01
Enrollment: 736 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of 2 doses of Avastin in combination with docetaxel, versus docetaxel plus placebo, in patients with metastatic HER2 negative breast cancer who are candidates for taxane-based chemotherapy but who have not received prior chemotherapy for metastatic disease. The anticipated time on treatment is 1-2 years and the target sample size is 500+ individuals.

Detailed description:
Five participants randomized to the docetaxel 100 mg/m\^2 plus placebo group actually received docetaxel 100 mg/m\^2 plus bevacizumab 7.5 mg/kg and are included in the docetaxel 100 mg/m\^2 plus bevacizumab 7.5 mg/kg group for the adverse event results. Sixteen participants randomized to the docetaxel 100 mg/m\^2 plus placebo group actually received docetaxel 100 mg/m\^2 plus bevacizumab 15.0 mg/kg and are included in the docetaxel 100 mg/m\^2 plus bevacizumab 15.0 mg/kg group for the adverse event results.

Arms: arm 1: Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal. arm 2: Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal. arm 3: Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
Interventions: intervention 1: Docetaxel intervention 2: Placebo to bevacizumab intervention 3: Bevacizumab
Intervention descriptions: intervention 1: Docetaxel was supplied in 2 vials, 1 containing docetaxel and 1 containing a solvent, for intravenous infusion. intervention 2: Placebo to bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials. intervention 3: Bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials.

Protocol documents:
Clinical trial NCT00392821
Conditions: Kidney Cancer
Sponsor: SCRI Development Innovations, LLC
Start date: 2006-12-01; Completion date: 2013-10-01
Enrollment: 78 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is being done in 2 parts. The first part is to determine the dose of RAD001 that should be used in combination with sorafenib. The second part is using the above determined dose of RAD001 in combination with sorafenib to see how effective these 2 drugs are against advanced kidney cancer.

Participants will be asked to keep a pill diary.

Detailed description:
The drugs used in this trial are called targeted drugs as they target specific activities that are carried out by cancer cells that make them grow and spread. Sorafenib is an approved drug for the treatment of advanced kidney cancer. RAD001 is an experimental drug that has been used in other research studies with other types of cancer. In this trial, the use of RAD001 and sorafenib together for the treatment of kidney cancer is experimental. In the Phase I portion of this study 13-16 patients will be treated with the same dose of sorafenib and different doses of RAD001. The purpose is to see what is a safe dose of RAD001 when combined with sorafenib in the treatment of kidney cancer. Once this dose of RAD001 is determined, about 65 more patients will be treated to see how effective this combination of drugs is against this kidney cancer.

Both of these drugs are taken by mouth. Sorafenib will be taken twice a day. RAD001 is taken by mouth weekly. Patients will be able to continue treatment as long as their disease does not worsen or side effects become intolerable.

Arms: arm 1: RAD001 and Sorafenib
Interventions: intervention 1: Sorafenib intervention 2: RAD001
Intervention descriptions: intervention 1: Sorafenib intervention 2: RAD001

Protocol documents:
Clinical trial NCT00414440
Conditions: Autosomal Dominant Polycystic Kidney Disease
Keywords: end-stage renal disease, ESRD, autosomal dominant polycystic kidney disease, ADPKD, everolimus
Sponsor: Novartis Pharmaceuticals
Start date: 2006-12-01; Completion date: 2013-10-01
Enrollment: 431 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess whether everolimus (RAD001) is effective in preventing cyst and kidney expansion as well as worsening of renal function in patients with ADPKD and whether the application of 5 mg/day everolimus as monotherapy is safe and well tolerated.

Detailed description:

Arms: arm 1: Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day \[5 mg b.i.d.\]). arm 2: Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses.
Interventions: intervention 1: Placebo intervention 2: Everolimus
Intervention descriptions: intervention 1: placebo comparator intervention 2: experimental

Protocol documents:
Clinical trial NCT00418145
Conditions: Multiple Sclerosis
Keywords: Relapsing Forms of Multiple Sclerosis
Sponsor: Fred Lublin
Start date: 2003-09-01; Completion date: 2013-10-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This clinical trial compares the relative efficacy of treating acute exacerbations of relapsing forms of Multiple Sclerosis with equivalent doses of oral and intravenous (IV) methylprednisolone. This is a randomized, blinded, multi-center study.

Detailed description:
Intravenous methylprednisolone has been the standard of care for treating acute MS flares. However, the IV administration is cumbersome, inconvenient and expensive. A true comparison of these different approaches has not been undertaken in rigorous fashion. Prior studies have demonstrated the safety of such high doses of oral steroid. For this proposal we employ equivalent oral dosing (1400 mg/day) and compare that to 1000 mg/day IV therapy in patients seen within seven days of an acute exacerbation of MS.

In addition, there are 2 arms to this double-blind, placebo controlled, randomized trial. One arm has an active IV and an oral placebo while the second arm has an IV placebo and an active oral dose. Therefore, each subject will receive an active treatment.

Arms: arm 1: 1400 mg qd/5 days arm 2: 1000 mg/qd/5 days
Interventions: intervention 1: megadose oral methylprednisolone intervention 2: IV methylprednisolone
Intervention descriptions: intervention 1: 1400 mg qd/5 days intervention 2: 1000 mg/qd/5 days

Protocol documents:
Clinical trial NCT00448916
Conditions: Epilepsies, Partial
Keywords: Partial-onset seizures; epilepsy; pediatric; pregabalin; 1 year extension study; safety; tolerability
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2007-05-01; Completion date: 2013-10-01
Enrollment: 54 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The study will evaluate the long-term safety and tolerability of pregabalin in pediatric patients, age 1 month through 16 years, with partial onset seizures.

Detailed description:

Arms: arm 1: Orally-administered pregabalin
Interventions: intervention 1: Pregabalin
Intervention descriptions: intervention 1: Orally-administered pregabalin

Protocol documents: