ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02047227
Conditions: Infertility
Keywords: ESPART Reproductive Techniques, Assisted Infertility Pergoveris® GONAL-f®
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2014-01-31; Completion date: 2015-08-31
Enrollment: 939 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 3, randomized, controlled, single-blind, multicenter, parallel-arm trial to assess the safety and efficacy of Pergoveris® (recombinant human follicle stimulating hormone \[r-hFSH\]/recombinant human luteinising hormone \[r-hLH\]) and GONAL-f® for multifollicular development as part of an assisted reproductive technology (ART) treatment cycle in poor ovarian responders, as aligned with the 2011 Consensus Meeting of the European Society of Human Reproduction and Embryology (ESHRE) criteria.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Pergoveris® intervention 2: GONAL-f® intervention 3: Recombinant human chorionic gonadotrophin (r-hCG)
Intervention descriptions: intervention 1: Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 International Unit (IU) recombinant human follicular stimulating hormone (rhFSH)/ 150 IU recombinant human luteinizing hormone (rhLH) after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 millimeter (mm); 250 microgram (mcg) of r-hCG (Ovidrel) was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject's response per site standard clinical practice. intervention 2: GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject's response per site standard clinical practice. intervention 3: On r-hCG day, 250 mcg of r-hCG was administered once subcutaneously

Protocol documents:
Clinical trial NCT02406261
Conditions: Healthy
Sponsor: AstraZeneca
Start date: 2015-04-30; Completion date: 2015-08-31
Enrollment: 82 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to study the effect of lanabecestat on how the body absorbs and processes 3 other medications, midazolam, simvastatin and donepezil and how these 3 medications affect lanabecestat when they are taken together. This study is in 2 cohorts, Cohort A is approximately 44 days long and Cohort B about 70 days only. The screening visit is required within 30 days prior to the start on the study

Detailed description:
Astra Zeneca (AZ) registered this trial as sponsor. In July, 2015, sponsorship changed to Eli Lilly and Company (Lilly). In August, 2015, AZ transferred this trial to Lilly's ClinicalTrials.gov account and Lilly updated the record. This trial is not an applicable trial under the Food and Drug Administration Amendments Act of 2007 (FDAAA).

Arms: arm 1: 500 microgram (mcg) midazolam, single oral dose on Days 1, 17, and 35;

20 mg simvastatin, single oral dose on Days 2 and 36;

250 microgram (mcg) midazolam, intravenous (IV) on Days 3 and 37;

50 mg lanabecestat, single oral dose on Day 4;

50 mg lanabecestat, single oral dose, Days 10 to 37 arm 2: 5 mg donepezil, single oral dose on Day 1, Period 1;

50 mg lanabecestat, single oral dose Days 1 to 43, Period 2;

5 mg donepezil, single oral dose on Day 28, Period 2
Interventions: intervention 1: Lanabecestat intervention 2: Simvastatin intervention 3: Midazolam intervention 4: Midazolam intervention 5: Donepezil intervention 6: Lanabecestat
Intervention descriptions: intervention 1: 50 mg lanabecestat will be administered orally as 1 × 50-mg tablet intervention 2: 20 mg simvastatin will be administered orally as 1 × 20-mg tablet intervention 3: 500 mcg midazolam will be administered orally as 0.25 mL of 2-mg/mL syrup intervention 4: 250 mcg midazolam will be administered intravenous (IV) as 0.25 mL of 1-mg/mL injection solution intervention 5: 5 mg donepezil will be administered orally as 1 × 5-mg tablet intervention 6: 50 mg lanabecestat will be administered orally as 1 × 50-mg tablet

Protocol documents:
Clinical trial NCT00135694
Conditions: Hepatitis C Hepatitis C, Chronic Nonimmune Nonviral Causes of Liver Failure
Keywords: hepatitis hepatitis C HCV liver liver disease liver transplant liver transplantation transplant hepatic hepatic transplantation immunosuppression rejection
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Start date: 2005-10-01; Completion date: 2015-09-01
Enrollment: 275 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In order to prevent organ rejection, patients receiving liver transplants currently require life-long treatment with immune system-suppressing medications to prevent the rejection of the transplanted liver. However, these medications can cause long-term side effects, such as infection, kidney problems, diabetes, and cancer. In patients infected with hepatitis C virus (HCV), these medications may increase the risk of HCV infection in the transplanted liver. The purpose of this study is to determine whether a slow withdrawal of immune system-suppressing medications is safe in two groups of subjects: those who receive a liver transplant due to HCV, and those who receive a liver transplant due to non-immune, non-viral causes of liver failure. The study will also look at whether slow withdrawal will help reduce the long-term side effects of immune system-suppressing medications and decrease the chance for HCV infection of the new liver in transplant patients with HCV.

Detailed description:
This is a prospective multicenter, open-label, randomized trial in which individuals with liver failure due to hepatitis C or to nonimmune nonviral causes undergo liver transplantation and receive immunosuppression with a calcineurin inhibitor and corticosteroids. Corticosteroids are tapered in the 3 months after transplantation and the calcineurin inhibitor is continued. Participants are regularly assessed for evidence of allograft rejection. One year after transplantation, participants eligible for withdrawal are randomly assigned in a 4 to 1 ratio to immunosuppression withdrawal or to maintenance. Participants assigned to withdrawal undergo a scheduled taper over approximately 1 year.

Arms: arm 1: Subjects may randomize to this group at 12 to 24 months after transplantation. This is followed by tapered withdrawal of calcineurin inhibitor-based immunosuppression therapy over the course of 1 year. arm 2: Liver transplant, followed by maintenance doses of continuous calcineurin inhibitor-based immunosuppression therapy.
Interventions: intervention 1: calcineurin inhibitor-based immunosuppression intervention 2: liver transplant intervention 3: corticosteroids intervention 4: immunosuppression withdrawal
Intervention descriptions: intervention 1: May be cyclosporine, mycophenolate mofetil, or tacrolimus intervention 2: Occurs at study entry intervention 3: 3-month course of corticosteroids intervention 4: One year after transplantation, participants eligible for withdrawal are randomly assigned in a 4 to 1 ratio to immunosuppression withdrawal or to maintenance.

Protocol documents:
Clinical trial NCT00800345
Conditions: Gynecologic Tumors
Keywords: Gynecologic tumors
Sponsor: Vector Oncology
Start date: 2009-04-01; Completion date: 2015-09-01
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 1, dose-escalation study in female patients with recurrent or persistent gynecologic tumors.

Detailed description:
This is a Phase 1, dose-escalation study in female patients with recurrent or persistent gynecologic tumors. The study will include a Screening Phase, a Treatment Phase and a Followup Phase. In the Screening Phase the subject's eligibility for study participation will be determined; this phase can last up to 28 days. The Treatment Phase will begin when the subject starts study treatment and will continue until the subject is removed from study treatment. The Follow-up Phase will last for 30 days after the subject ends study treatment. The study will be conducted at approximately 1 site. Treatment cycle length is 28 days. Radiologic imaging will be repeated after every 2 cycles of treatment.

Arms: arm 1: Metronomic oral topotecan and oral pazopanib will be administered by mouth beginning on Cycle 1 Day 1. Patients will be enrolled and observed for dose limiting toxicity (DLT) for 1 cycle of treatment. Dose modification of the combination will depend on the number of patients experiencing DLT(s) at each dose level.
Interventions: intervention 1: Oral Topotecan intervention 2: Pazopanib
Intervention descriptions: intervention 1: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of topotecan administered by mouth. intervention 2: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of pazopanib administered by mouth.

Protocol documents:
Clinical trial NCT01782326
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD, QVA149, FLAME( EFfect of Indacaterol Glycopyronium Vs Fluticasone salmeterol on COPD Exacerbations)
Sponsor: Novartis Pharmaceuticals
Start date: 2013-07-01; Completion date: 2015-09-01
Enrollment: 3362 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to very severe COPD.

Detailed description:

Arms: arm 1: QVA149 (110/50 μg) once daily arm 2: Salmeterol/fluticasone (50/500μg) b.i.d
Interventions: intervention 1: QVA149 intervention 2: Long acting B2 agonist (LABA) and inhaled corticosteroid (ICS)
Intervention descriptions: intervention 1: QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept 1 SDDPI. intervention 2: Salmeterol/fluticasone dry inhalation powder delivered via the Accuhaler device.

Protocol documents:
Clinical trial NCT01954121
Conditions: Epilepsy Partial Seizures
Keywords: Levetiracetam Keppra Monotherapy China Epilepsy Partial-onset Seizures
Sponsor: UCB Pharma SA
Start date: 2013-09-01; Completion date: 2015-09-01
Enrollment: 436 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To demonstrate the non-inferiority of Levetiracetam (1000 mg/day) versus Carbamazepine Immediate-Release (400 mg/day) used as monotherapy for at least 6 months in a Chinese population with newly or recently diagnosed Epilepsy who are experiencing Partial-Onset Seizures (POS).

Detailed description:

Arms: arm 1: Levetiracetam 1000 mg/day arm 2: Carbamazepine 400 mg/day
Interventions: intervention 1: Levetiracetam intervention 2: Carbamazepine
Intervention descriptions: intervention 1: Immediate release film-coated tablets at strengths of 250 mg and 500 mg.

* Up-titration Period (Week 1 to Week 3): Levetiracetam (LEV) 250 mg twice daily (bid)
* Stabilization Period and Evaluation Period (Week 3 to Week 30): LEV 500 mg bid
* Down-titration Period (Week 30 up to Week 33) intervention 2: Immediate release tablets at a strength of 200 mg.

* Up-titration Period (Week 1 to Week 3): Carbamazepine- Immediate Release (CBZ-IR) 200 mg once daily (qd)
* Stabilization Period and Evaluation Period (Week 3 to Week 30): CBZ-IR 200 mg bid
* Down-titration Period (Week 30 up to Week 33)

Protocol documents:
Clinical trial NCT00166439
Conditions: Lymphoma
Keywords: C04.557.386
Sponsor: Academic and Community Cancer Research United
Start date: 2005-03-01; Completion date: 2015-09-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goals of this protocol are to determine the effect of oxaliplatin, cytosine arabinoside, and dexamethasone with Rituxan (ROAD) as treatment for patients with relapsed CD20+ B-cell non-Hodgkins lymphoma (NHL).

Detailed description:
Patients with B-cell NHL that comes back after chemotherapy are typically treated with cisplatin, high-dose cytosine arabinoside and dexamethasone (DHAP) or other platinum-based treatments. Recent studies have shown a 37% response rate in patients with large cell lymphoma to immunotherapy with Rituxan. Patients \<75 years old and in otherwise good health may be candidates for high dose therapy with stem cell rescue if they have disease that remains sensitive to chemotherapy. Typically, patients are administered 2 cycles of DHAP or ICE (ifosfamide, carboplatin, and etoposide) and, if the disease responds, they proceed to high-dose therapy with stem cell support. Even patients not considered transplant candidates are also often treated with DHAP or ICE or other salvage regimens. It is likely that the response rate with DHAP alone in patients eligible for transplant is \<59%. Recent studies have attempted to improve on the results from DHAP or ICE by combining them with rituxan. NCCTG has just completed a phase II trial of R-DHAP. Preliminary results of the R-ICE protocol indicate a higher response rate and longer time to progression than traditional ICE.

The problem with DHAP and ICE is that they are associated with significant side effects and specifically, with DHAP the cisplatin often causes kidney problems. In fact, some patients who are considered transplant eligible before DHAP may become transplant ineligible simply by the kidney side effects. Clearly, there is a need to improve the quality of life of patients undergoing treatment and to avoid the kidney problems.

Arms: arm 1: The treatment regimen included oxaliplatin with rituximab, cytarabine, and dexamethasone (ROAD); specifically, rituximab 375 mg/m\^2 IV on days 1, 8,15, and 22 (cycle 1 only); dexamethasone 40 mg PO/IV days 2-5; oxaliplatin 130 mg/m\^2 IV over 2 hours on day 2; cytarabine 2000 mg/m\^2 IV in 250 mL of D5W over three hours x two doses on days 2-3. The second dose of cytarabine was to be given no sooner than 12 hours after the first dose and no later than 24 hours after the conclusion of the first dose. This permitted outpatient administration if desired. Patients were provided pegfilgrastim 6 mg SC on day 4. A cycle was 21 days.
Interventions: intervention 1: Oxaliplatin, Cytosine Arabinoside, Dexamethasone With Rituxan (ROAD)
Intervention descriptions: intervention 1: rituximab 375 mg/m2 IV Weekly x 4 1 cycle only

dexamethasone 40 mg PO/IV Days 2-5 q 21 days 2 cycles

oxaliplatin 130 mg/m2 IV Day 2 q 21 days 2 cycles

cytosine arabinoside 2000 mg/m2 x 2 doses IV Days 2-3 q 21 days 2 cycles

pegfilgrastim 6 mg SQ Day 4 q21 days 2 cycles

Protocol documents:
Clinical trial NCT00266656
Conditions: Turner Syndrome
Sponsor: Eli Lilly and Company
Start date: 2005-12-01; Completion date: 2015-09-01
Enrollment: 69 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an extension study that will gather long-term data on the effect of early growth hormone (GH) treatment on adult height and other aspects of health and development in girls with Turner syndrome. The main purpose is to determine whether girls who received 2 years of GH treatment before 6 years of age achieve taller adult height than girls who were untreated during this time. The study will also look at middle ear and hearing function, and cognitive and behavioral development. Protocol completion is defined as attainment of height velocity less than or equal to 1.0 cm/year, or bone age greater than or equal to 15 years.

Detailed description:

Arms: arm 1: No drug administration in B9R-US-GDFG (NCT00406926).

Humatrope according to investigator's clinical practice and guided by the approved package insert on whether treatment is given. arm 2: Humatrope according to investigator's clinical practice and guided by the approved package insert on whether treatment is given.
Interventions: intervention 1: Humatrope
Intervention descriptions: intervention 1: According to investigator's clinical practice and guided by the approved package insert

Protocol documents:
Clinical trial NCT00486642
Conditions: Hormone-Resistant Prostate Cancer Recurrent Prostate Carcinoma
Sponsor: National Cancer Institute (NCI)
Start date: 2007-09-01; Completion date: 2015-09-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial is studying how well giving pazopanib with or without bicalutamide works in treating patients with prostate cancer that did not respond to hormone therapy. Pazopanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the amount of androgens made by the body. Giving pazopanib hydrochloride together with bicalutamide may be an effective treatment for prostate cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the therapeutic activity of GW786034 (pazopanib hydrochloride) with and without bicalutamide in the treatment of hormone-refractory prostate cancer using prostate specific antigen (PSA)-response rate.

SECONDARY OBJECTIVES:

I. To estimate objective tumor response in patients with measurable disease. II. To estimate the median time to progression. III. To investigate the safety and tolerability of GW786034 with and without bicalutamide.

IV. To estimate the median duration of PSA-response. V. To determine the steady state levels of GW786034 with and without bicalutamide.

VI. To investigate the correlation between prior exposure to bicalutamide and non-steroidal anti-androgens with response and survival outcomes.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-28.

ARM II: Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.

Courses in both arms repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 4 weeks for 12 weeks.

Arms: arm 1: Patients receive pazopanib hydrochloride PO QD on days 1-28.

. arm 2: Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.
Interventions: intervention 1: Bicalutamide intervention 2: Laboratory Biomarker Analysis intervention 3: Pazopanib Hydrochloride intervention 4: Pharmacological Study
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies intervention 3: Given PO intervention 4: Correlative studies

Protocol documents:
Clinical trial NCT00519896
Conditions: Recurrent Thyroid Cancer Stage IVA Follicular Thyroid Cancer Stage IVA Papillary Thyroid Cancer Stage IVB Follicular Thyroid Cancer Stage IVB Papillary Thyroid Cancer Stage IVC Follicular Thyroid Cancer Stage IVC Papillary Thyroid Cancer Thyroid Gland Medullary Carcinoma
Sponsor: University of Washington
Start date: 2007-07-01; Completion date: 2015-09-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well giving sunitinib malate works in treating patients with iodine-refractory recurrent or metastatic thyroid cancer. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor

Detailed description:
PRIMARY OBJECTIVES:

I. Evaluate the response of sunitinib (sunitinib malate) per Response Evaluation Criteria in Solid Tumors (RECIST) criteria in patients with recurrent/metastatic iodine refractory well differentiated thyroid carcinoma (WDTC) or medullary thyroid carcinoma (MTC).

SECONDARY OBJECTIVES:

I. Evaluate early positron emission tomography (PET) changes in patients with WDTC and MTC treated with sunitinib.

II. Determine the safety and toxicity of sunitinib given as a continuous treatment in patients with WDTC and MTC.

III. Evaluate the effect of sunitinib therapy on overall survival, duration of response and time-to-progression.

IV. Evaluate serial tumor markers, thyroglobulin (WDTC) or calcitonin (MTC), during therapy. These measurements will not be used to define disease progression or response.

V. Correlate changes in serial tumor markers with radiologic response.

OUTLINE:

Patients receive sunitinib malate orally (PO) once daily (QD). Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then for 2 years.

Arms: arm 1: Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: sunitinib malate
Intervention descriptions: intervention 1: Given PO

Protocol documents:
Clinical trial NCT00534703
Conditions: Chronic Heart Failure Patients That Have Received a Left Ventricular Assist Device
Keywords: Chronic Heart Failure
Sponsor: Imperial College London
Start date: 2014-07-01; Completion date: 2015-09-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to determine the safety and feasibility of giving an adeno-associated viral vector expressing the sarcoplasmic reticulum calcium ATPase (SERCA2a), driven by the CMV promoter (AAV1-CMV-SERCA2a), to heart failure patients that have received a left ventricular assist device (LVAD) for an accepted clinical indication.

Detailed description:
It is a randomised, double-blind study of 24 patients that will be randomised to receive either the study drug (AAV1.SERCA2a) or placebo.

The purpose of gene transfer of SERCA2a is to improve systolic and diastolic function of the failing ventricle. Studies show that reduction of SERCA2a in failing ventricle is a key factor in depression of contraction, and that restoration of SERCA2a levels can improve function to near normal levels. The vector will be delivered during a cardiac catheterisation procedure by a 10-minute infusion into the coronary arteries.

Myocardial tissue is obtained at the time of LVAD placement, as a routine part of device implantation. Further samples will be obtained when the heart is transplanted or the LVAD removed. Measures of tissue inflammation as well as efficacy of gene transfer will be made by comparing these two samples. Recovery of contractile function of the heart will be assessed during attempts to wean patients from the LVAD using standard protocols.

The results will be assessed in conjunction with two companion studies which will start earlier in the US, one performing SERCA2a gene transfer with the same vector, but delivered by direct injection into the myocardium during LVAD insertion, and one using AAV1-CMV-SERCA2a delivered percutaneously in heart failure patients. The latter has both a dose-ranging and placebo-controlled arm.

Arms: arm 1: SERCA gene therapy arm 2: Placebo (saline solution)
Interventions: intervention 1: AAV1/SERCA2a intervention 2: Placebo
Intervention descriptions: intervention 1: AAV1/SERCA2a will be delivered by a percutaneous method in the catheter laboratory. Dose: 1x 10\^13 DRP (DNase resistant particles) intervention 2: Placebo aliquots will be of the same composition as the investigational medicinal product with the absence of the active ingredient and will be visually indistinguishable from the medicinal product. Placebo is prepared and handled exactly as above in a blinded fashion.

Protocol documents: