ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01342484
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2011-04-01; Completion date: 2016-02-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objective of this study is to identify the dose of linagliptin in paediatric patients.

Other efficacy objectives include the comparison of the lowering effect of linagliptin low dose, high dose and placebo on the fasting plasma glucose (FPG) observed after 12 wk of treatment.

Furthermore, the study will investigate the pharmacokinetics (PK), the pharmacodynamics (PD) and the PK/PD relationship of linagliptin in the paediatric population.

Detailed description:

Arms: arm 1: linagliptin low dose for children once daily arm 2: linagliptin high dose for children once daily arm 3: matching placebo for each linagliptin dose once daily
Interventions: intervention 1: placebo intervention 2: BI1356 low dose intervention 3: BI1356 high dose
Intervention descriptions: intervention 1: comparison of different dosages of drug (low vs high) vs placebo intervention 2: comparison of different dosages of drug (low vs high) vs placebo intervention 3: comparison of different dosages of drug (low vs high) vs placebo

Protocol documents:
Clinical trial NCT01366885
Conditions: Autistic Disorder
Keywords: Autism Pregnancy Newborn siblings
Sponsor: Oregon Health and Science University
Start date: 2008-02-01; Completion date: 2016-02-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether by administering vitamin D to mothers who already have at least one child with autism and who are pregnant, that the vitamin D will prevent the recurrence of autism in the newborn sibling.

Detailed description:
The incidence of autism is increasing. Also, women of childbearing age are increasingly found to be insufficient/deficient in vitamin D. Vitamin D is a neurohormone which is important for development of the child, especially of the child's brain. The primary source of vitamin D is from the sun through one's skin. People have been avoiding the sun because of skin cancer, because of increasing Television watching, computer viewing and wearing clothes that cover most of the body. This approach will study whether making the pregnant mother, whose child is at risk for autism because of a previous child with autism, replete with vitamin D will prevent that recurrence of autism in the newborn sibling.

Arms: arm 1: 5000 IU Vitamin D3 to be given to the mother during pregnancy. 7000 IU Vitamin D3 to be given during breast feeding if breast feeding. If not breastfeeding, infant to be given 400 IU Vitamin D3 during first year of age, then increased to 1000 IU D3 until completion of research trial.
Interventions: intervention 1: Vitamin D3
Intervention descriptions: intervention 1: 5000 IU D3 capsule oral/day for entire pregnancy. 7000 IU D3/day during breastfeeding. If not breast feeding, baby gets 400 IU D3/day. Baby increased to 1000 IU D3/day at one year of age.

Protocol documents:
Clinical trial NCT01375010
Conditions: HIV
Keywords: HIV Postmenopausal women Vitamin D
Sponsor: Columbia University
Start date: 2011-01-01; Completion date: 2016-02-01
Enrollment: 85 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effects of vitamin D on measures of bone health and immune function in HIV infected postmenopausal women. The investigators prior research with this population revealed that low vitamin D levels are very common. Prior research with this population also revealed that Vitamin D is necessary for the body to absorb calcium and is important for the health of the bones. When vitamin D levels are low, there are increased risks of bone loss, muscle weakness, falls and fractures. Low levels of vitamin D have also been associated with impaired immune function. This study will help us learn whether two different doses of vitamin D will improve bone health and immune function.

Detailed description:
The purpose of this study is to determine the effects of vitamin D repletion on rates of bone loss and indices of immune function in HIV+ postmenopausal women. Lower baseline serum Vitamin D levels, as assessed by measuring serum 25-hydroxyvitamin D (25-OHD) were associated with a trend toward more bone loss. In addition, the investigators found that despite providing supplements that contained approximately 600 IU vitamin D, serum 25-OHD did not increase during the first year. Provision of adequate calcium and vitamin D is the cornerstone of effective prevention and therapy of osteoporosis. HIV-infected patients may be at increased risk of having vitamin D deficiency because they take several medications that may interfere with vitamin D action. Therefore, the investigators will recruit 100 HIV infected postmenopausal women for this study who are on a stable antiretroviral therapy (ART) regimen and randomize them to receive 1000 or 3000 IU of vitamin D daily. The subjects will be followed closely for one year to monitor compliance and changes in bone health and immune function.

Arms: arm 1: Placebo vitamin D3 capsule daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 1000 IU. arm 2: 2000 IU vitamin D3 daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 3000 IU.
Interventions: intervention 1: Vitamin D3 intervention 2: Placebo intervention 3: Vitamin Supplements
Intervention descriptions: intervention 1: 2000 mg QD intervention 2: An inactive treatment that is intended to provide baseline measurements for the experimental protocol of a clinical trial, in this case, the vitamin D3. intervention 3: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D).

Protocol documents:
Clinical trial NCT01385293
Conditions: Prostate Cancer Metastatic (Spread to Other Areas of the Body)
Keywords: BKM120 prostate cancer metastatic castrate-resistant prostate cancer (mCRPC)
Sponsor: Andrew J. Armstrong, MD
Start date: 2011-08-01; Completion date: 2016-02-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effects of the study drug, BKM120. The study drug, BKM120, is an inhibitor of a protein called phosphatidyl inositol-3-kinase (PI3K). This protein is found in normal cells and in cancer cells, but often in many cancer cells this protein is overactive. Inhibiting the protein may slow the growth of prostate cancer but this has not been tested yet in men with prostate cancer.

Detailed description:
This is an open label, single arm phase II study of BKM120 in men with metastatic castration resistant prostate cancer (CRPC) who have progressed on or following completion of docetaxel-based chemotherapy. Prior progression on cabazitaxel, provenge, abiraterone, or enzalutamide (MDV3100) is also permitted. Patients must have baseline evaluations performed prior to the first dose of study drug and must meet all inclusion and exclusion criteria. Results of the baseline evaluations, which assure that all inclusion and exclusion criteria have been satisfied, must be reviewed by the Principal Investigator or his/her designee prior to enrollment of that patient. In addition, the patient must be thoroughly informed about all aspects of the study, including the study visit schedule and required evaluations and all regulatory requirements for informed consent. The written informed consent must be obtained from the patient prior to protocol-specific screening tests. The following criteria apply to all patients enrolled onto the study unless otherwise specified.

Arms: arm 1: BKM120 at 100mg orally daily
Interventions: intervention 1: BKM120
Intervention descriptions: intervention 1: BKM120 at the maximum tolerated dose (MTD) of 100mg orally daily

Protocol documents:
Clinical trial NCT01458249
Conditions: Soft Tissue Sarcoma
Keywords: Soft Tissue Sarcoma
Sponsor: Eisai Co., Ltd.
Start date: 2011-11-01; Completion date: 2016-02-01
Enrollment: 52 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to evaluate the efficacy and safety of eribulin mesylate in subjects with soft tissue sarcoma who received at least one standard chemotherapy (an anthracycline or an ifosfamide monotherapy or a combination therapy).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: eribulin mesylate
Intervention descriptions: intervention 1: Administration of eribulin mesylate at a dose of 1.4 mg/m\^2 as an IV bolus infusion over 2-5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days.

Protocol documents:
Clinical trial NCT01465347
Conditions: Glioblastoma GBM Glioma
Keywords: Primary brain tumor Glioblastoma Glioma GBM Radiation therapy
Sponsor: Diffusion Pharmaceuticals Inc
Start date: 2012-02-01; Completion date: 2016-02-01
Enrollment: 59 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label study evaluated the safety and efficacy of TSC when dosed concomitantly with the standard of care (radiation therapy and temozolomide) for newly diagnosed glioblastoma in adults. All patients received TSC in the study. The objective of the study was to evaluate the effect of TSC on survival and tumor response in patients with GBM while establishing an acceptable patient risk profile.

Detailed description:
The overall objectives of this Phase 1/2 clinical study in newly diagnosed GBM patients was to evaluate the safety and tolerability, efficacy, PK profile, PFS/time to disease progression, QoL, and overall survival in adults when TSC is added to the standard of care regimen of radiation therapy and temozolomide. All patients received TSC in this study. The primary objective of the Phase 1 portion of the study was to evaluate the safety (DLT rate) and to define the dosing regimen of TSC for the larger Phase 2 study. The primary clinical endpoint was overall survival at 24 months and patients will be followed for up to 3 years.

Arms: arm 1: This was an open-label, sequential-cohort, dose-escalation study in two phases. Phase 1 was a safety run-in evaluating Trans Sodium Crocetinate (TSC) in 3 subjects who received 3 doses per week for 3 weeks (9 doses in total). Phase 2 engaged 56 subjects who received 3 doses per week for 6 weeks (18 doses in total). TSC was consistently dosed at 0.25mg/kg in both phases.
Interventions: intervention 1: Trans Sodium Crocetinate (TSC)
Intervention descriptions: intervention 1: TSC administered intravenously as a bolus injection prior to radiation therapy sessions during 6 weeks of radiotherapy.

Protocol documents:
Clinical trial NCT01474486
Conditions: Congestive Heart Failure Ischemic Cardiomyopathy
Keywords: thiamin pyridoxine vitamin D zinc congestive heart failure (CHF) ischemic cardiomyopathy nutritional injury quality of life
Sponsor: Phoenix VA Health Care System
Start date: 2010-04-01; Completion date: 2016-02-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this project is to conduct a preliminary test of the feasibility of a multi-micronutrient intervention to improve micronutrient status, cardiac function and quality of life in Veterans with Congestive Heart Failure (CHF).

Detailed description:
Veterans with stable CHF resulting from ischemic cardiomyopathy with systolic dysfunction and an ejection fraction ≤45% and who fit the criteria of stage B, C and D 2 heart failure will be recruited. This is a one group study with Veterans serving as their own control. They will receive 50 mg thiamin, vitamin B50 and 220 mg Zn as Zn sulfate daily for 6 months. Additionally, they will receive 50,000 IU Vitamin D as ergocalciferol each week for 8 weeks then every other week for 16 weeks. Pre (baseline) and post (6 months) cardiac function will be tested with echocardiogram and cardiac MR (when applicable), biochemical measures of thiamine, pyridoxine, zinc and Vitamin D will be measured at baseline, 3 months, 6 months and one year. Quality of life will be measured using the Minnesota Living with Heart Failure questionnaire baseline, month 3,6,and one year. Nutritional assessment including a nutrition focused physical examination and three days food records will also be measured at baseline, month 3, 6 and one year.

Arms: arm 1: Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, and Zinc Sulfate (Zn SO4) one tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4)
Interventions: intervention 1: Micronutrients
Intervention descriptions: intervention 1: Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, and Zinc Sulfate (Zn SO4) one tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4)

Protocol documents:
Clinical trial NCT01509677
Conditions: COPD Chronic Obstructive Pulmonary Disease
Keywords: Roflumilast Chronic Obstructive Pulmonary Disease COPD
Sponsor: AstraZeneca
Start date: 2012-02-01; Completion date: 2016-02-01
Enrollment: 158 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the Biopsy trial is to investigate the effect of roflumilast 500 µg tablets once daily versus placebo on inflammation parameters in bronchial biopsy tissue specimen and additional in sputum and blood serum. Also data on safety status will be obtained.

Patients to be included required to have moderate to severe COPD associated with chronic bronchitis. The total duration of this randomized, multicentre, phase III trial is 24 weeks maximum.

Detailed description:
This was a multicenter, double-blind, randomized, parallel group, phase 3 study. Patients included had a history of COPD (GOLD stage II-III, in Germany stage II only) with chronic productive cough.

There were 2 parallel treatment arms (placebo and roflumilast 500 μg once daily). A 1 to 1 randomization scheme was used, that is, patients were allocated to roflumilast 500 μg or placebo in equal proportions. Randomization was stratified by concomitant LABA use.

The total duration of this study was 24 weeks maximum per patient. The study consisted of the following periods:

* Single-blind placebo run-in period (6 weeks) with visits at Week -6 (visit 0 \[V0\]), Week -2 (V1), and Week 0 (V2, randomization visit), during which all patients received placebo.
* Double-blind treatment period (16 weeks) during which patients received either roflumilast or matching placebo with visits at Week 6 (V4), Week 14 (V5), and Week 16 (V6).

An additional visit (V3) within 2 weeks after bronchoscopy/bronchial biopsy was performed purely as a safety visit. The exact timing of this safety visit was to be determined by the investigator. Safety follow-up. All AEs were followed up to 30 days after the double-blind treatment period. An additional safety visit, V7, was scheduled within 2 weeks after the second bronchoscopy. The exact timing of the safety visit was to be determined by the investigator.

Patients were required not to take any food or drink overnight for at least 8 hours prior to returning to the study center for each visit. Patients were also asked to avoid strenuous exercise for 8 hours prior to each study visit and to avoid smoking for 4 hours prior to each study visit.

For visits where patients did not undergo blood collections or biopsies, the fasting requirement was only mandated if clinically indicated, per investigator judgment.

Arms: arm 1: 500 μg tablet, once daily, oral administration in the morning after breakfast arm 2: tablet, once daily, oral administration in the morning after breakfast
Interventions: intervention 1: Roflumilast intervention 2: Placebo
Intervention descriptions: intervention 1: 500 μg tablet, once daily, oral administration in the morning after breakfast intervention 2: tablet, once daily, oral administration in the morning after breakfast

Protocol documents:
Clinical trial NCT01515956
Conditions: Mucopolysaccharidosis IVA Morquio A Syndrome MPS IVA
Keywords: Mucopolysaccharidosis IVA type A MPS IVA Type A Mucopolysaccharidosis IVA MPS IVA Morquio A Syndrome Lysosomal Storage Disorder LSD N-acetylgalactosamine-6-sulfatase N-acetylgalactosamine-6-sulfate sulfatase galactose-6-sulfatase GALNS enzyme replacement therapy ERT
Sponsor: BioMarin Pharmaceutical
Start date: 2011-10-01; Completion date: 2016-02-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label Phase 2 study will evaluate the safety and efficacy of weekly 2.0 mg/kg/wk infusions of BMN 110 in pediatric patients, less than 5 years of age at the time of administration of the first dose of study drug, diagnosed with MPS IVA (Morquio A Syndrome) for up to 208 weeks.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: BMN 110
Intervention descriptions: intervention 1: Patients will receive intravenous (IV) infusions of study drug at a dose of 2.0 mg/kg/wk over a period of approximately 4 hours every week for up to 208 weeks.

Protocol documents:
Clinical trial NCT01525407
Conditions: Malignant Neoplasm
Sponsor: Fred Hutchinson Cancer Center
Start date: 2012-05-01; Completion date: 2016-02-01
Enrollment: 83 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies donor atorvastatin treatment for the prevention of severe acute graft-versus-host disease (GVHD) in patients undergoing myeloablative peripheral blood stem cell (PBSC) transplantation. Giving chemotherapy and total-body irradiation (TBI) before a donor PBSC transplant helps stop the growth of cancer cells. It may also prevent the patient's immune system reject the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving atorvastatin to the donor before transplant may prevent this from happening.

Detailed description:
PRIMARY OBJECTIVES:

I. To assess whether 2 weeks of donor statin treatment reduces the risk of severe acute GVHD.

SECONDARY OBJECTIVES:

I. To assess whether 2 weeks of statin treatment of normal PBSC donors is feasible, tolerable and safe.

OUTLINE:

Donors receive atorvastatin orally (PO) beginning on day -14 and continuing until the last day of stem cell collection.

Arms: arm 1: Donors receive atorvastatin calcium PO beginning on day -14 and continuing until the last day of stem cell collection.
Interventions: intervention 1: Allogeneic Hematopoietic Stem Cell Transplantation intervention 2: Atorvastatin Calcium intervention 3: Peripheral Blood Stem Cell Transplantation
Intervention descriptions: intervention 1: Undergo myeloablative allogeneic PBSC transplant intervention 2: Given PO intervention 3: Undergo myeloablative allogeneic PBSC transplant

Protocol documents:
Clinical trial NCT01529749
Conditions: HIV-1 Infection
Sponsor: Felipe Garcia
Start date: 2012-02-01; Completion date: 2016-02-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a open controlled trial in which 48 HIV-1 patients successfully treated with EFV/FTC/TDF will be randomized to one of 4 groups in equal proportion between arms (1:1). The four arms are as follows:

Arm I: EFV / FTC / TDF (n = 12) Arm II: EFV / FTC / TDF + LST (n = 12) Arm III: FTC / TDF + MK-0518 (n = 12) Arm IV: FTC / TDF + LST + MK-0518 (n = 12)

The allocation will take place in two phases:

Phase I: 24 patients 1:1 receiving EFV/FTC/TDF vs. EFV/FTC/TDF + Losartan

If losartan arm shows benefits we will proceed to the second phase:

Phase II: 24 patients 1:1 to receive FTC/TDF+ MK-0518 versus FTC/TDF + MK-0518 + losartan.

Patients will be followed up during 12 months to determinate the proportion of patients with decreased collagen deposition in TL equal to or greater than 50%.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: EFV/FTC/TDF + Losartan intervention 2: EFV/FTC/TDF intervention 3: FTC/TDF + MK-0518 intervention 4: FTC/TDF+MK-0518+Losartan
Intervention descriptions: intervention 1: EFV/FTC/TDF --\> oral, 600/200/245 mg, od Losartan --\> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12. intervention 2: 600/200/245 mg, od, oral intervention 3: FTC/TDF --\> 200/245 mg, oral MK-0518 --\> 400 mg, oral intervention 4: FTC/TDF --\> 200/245 mg, oral MK-0518 --\> 400 mg, oral Losartan --\> -\> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.

Protocol documents: