ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00945256
Conditions: Aging
Keywords: metabolism exercise sodium nitroprusside
Sponsor: The University of Texas Medical Branch, Galveston
Start date: 2003-05-01; Completion date: 2009-05-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this study was to examine the role skeletal muscle perfusion plays in mediating muscle protein synthesis in healthy older and younger individuals. The investigators hypothesized that normalization of muscle perfusion in older men and women via exercise or infusion of a vasodilator would enhance nutritive flow and skeletal muscle protein synthesis in the elderly similar to that of their younger counterparts.

Detailed description:
The purpose of this study was to examine muscle protein metabolism in healthy young and elderly subjects during pharmacologic vasodilation of the lower limb vasculature in combination with increased amino acids delivery. We obtained femoral arteriovenous blood samples and v. lateralis muscle biopsies during a primed continuous infusion of L-\[ring-13C6\] Phenylalanine. Muscle protein kinetics were measured in the basal state and during a 180 min infusion of sodium nitroprusside (SNP) and amino acids (Premsol 10%) (SNP+AA). Skeletal muscle microvascular recruitment and flow were measured during the basal state and SNP+AA using contrast-enhanced ultrasound (CEU).

Arms: arm 1: 45 minutes of treadmill walking at 40% VO2 peak arm 2: 45 minutes of treadmill walking at 40% VO2 peak arm 3: Sodium Nitroprusside given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min arm 4: Sodium Nitroprusside given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min arm 5: Sodium Nitroprusside given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min and 7.5g amino acid drink taken orally
Interventions: intervention 1: Aerobic Exercise intervention 2: Sodium Nitroprusside intervention 3: Amino Acid Drink
Intervention descriptions: intervention 1: 45 minuties of treadmill walking was completed at 40% VO2 peak intervention 2: Sodium Nitroprusside was given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min intervention 3: 7.5 gram Amino Acid drink

Protocol documents:
Clinical trial NCT00953615
Conditions: Primary Sclerosing Cholangitis
Keywords: PSC Thalidomide
Sponsor: Mayo Clinic
Start date: 2006-04-01; Completion date: 2009-05-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the safety and benefit of Thalidomide with primary sclerosing cholangitis (PSC). This is a six month study.

Detailed description:
At entry, patients will have a complete history and physical, blood tests, ultrasound, and will complete questionnaires. Eligible patients will take Thalidomide 400 mg once a day in the evening. Patients will start a dose of 100 mg per day for two weeks, increasing by 100 mg per day every two weeks to a maximum dose of 400 mg per day for 6 months. Patients will return at 6 months for an evaluation, blood tests and completion of questionnaires. Blood tests will be performed by mailed-in kits at 3 months. Patients will receive weekly phone calls for the first 2 months and bi-monthly thereafter.

Arms: arm 1: Participants will be treated with Thalidomide, starting at a dose of 100 mg per day, increasing the dose by 100 mg every 14 days to a maximum of 400 mg per day.
Interventions: intervention 1: Thalidomide
Intervention descriptions: intervention 1: Titrate to 400 mg daily for 6 months

Protocol documents:
Clinical trial NCT00971282
Conditions: Healthy Skin
Sponsor: Galderma R&D
Start date: 2008-12-01; Completion date: 2009-05-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a single-center study, randomized, Investigator/Evaluator-blinded bilateral (split-face) comparison.

The objective: To assess the benefit of the concomitant use of a Moisturizing Lotion in reducing the skin irritation induced by a adapalen gel treatment in Chinese Subjects.

Detailed description:
The interest \& relevance of the concomitant use of a non-comedogenic moisturizer in order to decrease retinoid irritation has already been demonstrated in Caucasian patients. Such interest of associating a moisturizer when Differin® gel is prescribed has not been demonstrated in Asian populations.

Arms: arm 1: None
Interventions: intervention 1: adapalen 0.1% intervention 2: Cetaphil®
Intervention descriptions: intervention 1: Intra-individual (split-face) comparison: Differin® 0.1% (whole face) will be applied once daily for 4 weeks.

Visits will be conducted weekly for a maximum of 5 visits. intervention 2: Intra-individual (split-face) comparison: Cetaphil® (only one side of the face) will be applied once daily for 4 weeks.

Visits will be conducted weekly for a maximum of 5 visits.

Protocol documents:
Clinical trial NCT01035073
Conditions: Major Depressive Disorder Soft Tissue Discomfort Syndrome Pain
Sponsor: University of Pennsylvania
Start date: 2006-04-01; Completion date: 2009-05-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to determine the time course of duloxetine efficacy on the symptoms of Major Depressive Disorder (MDD)and on the symptoms of Soft Tissue Discomfort Syndrome(STDS) via use of 24-hour Actigraph™ measures.

We hypothesize that there will be a reduction in both MDD and STDS symptoms in MDD patients with co-morbid STDS symptoms. We further hypothesize that there will be a rapid improvement in functional outcome ratings and 24-hour activity in MDD patients with co-morbid STDS symptoms which may occur even before the antidepressant effect is observed.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Duloxetine
Intervention descriptions: intervention 1: 30-60 mg daily for 8 weeks

Protocol documents:
Clinical trial NCT01073605
Conditions: Growth Disorders Intrauterine Growth Retardation
Keywords: Short height intra-uterine growth retardation Genotonorm continuous treatment intermittent treatment
Sponsor: Pfizer
Start date: 1993-07-01; Completion date: 2009-05-01
Enrollment: 208 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the effect of continuous and intermittent administration of Genotonorm on stature in short prepubertal children with intra-uterine growth retardation

Detailed description:

Arms: arm 1: Continuous 0.7 IU/kg/week or 0.03 mg/kg/day arm 2: Continuous, 1.4 IU/kg/week or 0.06 mg/kg/day arm 3: Intermittent, 1.4 IU/kg/week or 0.06 mg/kg/day
Interventions: intervention 1: Genotonorm intervention 2: Genotonorm intervention 3: Genotonorm
Intervention descriptions: intervention 1: 0.7 IU/kg/week or 0.03 mg/kg/day, daily subcutaneous injection intervention 2: 1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection intervention 3: 1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection Intermittent treatment (6 months with treatment and 6 months without)

Protocol documents:
Clinical trial NCT01104545
Conditions: Hypertension
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-11-01; Completion date: 2009-05-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine if MK-3614, given as single doses, is safe and well tolerated in healthy males and male participants with mild to moderate hypertension.

Detailed description:
Up to three planned panels of either 8 healthy participants (Panels A and B) or 8 participants with mild to moderate hypertension (Panel C) will be enrolled. In Panels A and B, 8 participants will alternately receive single rising doses of MK-3614 or placebo. All doses will be administered in the fasted state, except Panel A, Period 3 in which a standard high-fat breakfast provided approximately 30 minutes prior to dosing. Panel A will begin first. At least 3 days will elapse before participants in the alternate panel (Panel B) will receive the next higher dose. In Panel C, 8 mild to moderate hypertensive male participants will receive single rising doses of MK-8892 or placebo. For all panels, there will be at least 7 days washout between treatment periods for any given participant. Participants may only be enrolled in one panel of the study. All participants in periods of all panels (with exception of 0.25 mg fasted/fed periods) will be randomly assigned to either study drug or placebo, i.e., a participant could be assigned to receive study drug in one period and placebo in another. As per the protocol allocation plan, the same participants will receive 0.25 mg MK-3612 in a fasted and fed state.

Arms: arm 1: Healthy participants receive single oral dose of MK-3614 0.25 mg, 1.25 mg, 0.25 mg w/ food, 0.75 mg or matching placebo. There is at least a 7-day washout between the 4 dosing periods. All doses were administered after an 8-hour fast except for Period 3. Period 3 dose was administered after the ingestion of a high-fat breakfast. arm 2: Healthy participants receive single oral dose of MK-3614 0.5 mg. 0.75 mg, 0.25 mg twice a day (b.i.d.), 0.25 mg three times a day (t.i.d), or matching placebo. There is at least a 7-day washout between the 4 dosing periods. All doses were administered after an 8-hour fast arm 3: Hypertensive participants receive single oral dose of MK-3614 0.75 mg. 0.5 mg. 0.75 mg, 0.75 mg or matching placebo. There is at least a 7-day washout between the 4 dosing period. All doses were administered after an 8-hour fast
Interventions: intervention 1: MK-3614 intervention 2: Comparator: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01280981
Conditions: Menorrhagia
Keywords: Menorrhagia Heavy Menstrual Bleeding Lysteda
Sponsor: Ferring Pharmaceuticals
Start date: 2007-04-01; Completion date: 2009-05-01
Enrollment: 288 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This was a multicenter, open-label extension study for subjects completing either of 2 pivotal efficacy studies (NCT00401193 or NCT00386308). The study consisted of a treatment phase of 9 menstrual periods to assess the safety of tranexamic acid at an oral dose of 1.3 g administered 3 times per day for up to 5 days (maximum of 15 doses) during menstruation. After the last treatment period, a follow-up phone call occurred approximately 30 days (range 25 to 35 days) after the last dose of study drug.

Detailed description:

Arms: arm 1: Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
Interventions: intervention 1: Tranexamic acid
Intervention descriptions: intervention 1: Tranexamic acid at an oral dose of 1.3 g administered 3 times per day for up to 5 days (maximum of 15 doses) during menstruation for 9 menstrual periods.

Protocol documents:
Clinical trial NCT01591317
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2009-03-01; Completion date: 2009-05-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate how the body processes prasugrel and how prasugrel affects blood clotting in healthy Korean men. Three different dosing regimens of prasugrel will be given. Information on side effects will also be collected.

Detailed description:

Arms: arm 1: Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days arm 2: Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days arm 3: Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
Interventions: intervention 1: Prasugrel
Intervention descriptions: intervention 1: Tablets orally

Protocol documents:
Clinical trial NCT01787279
Conditions: Hepatitis B, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2006-01-01; Completion date: 2009-05-01
Enrollment: 59 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an expanded access programme to make Pegasys (peginterferon alfa-2a) available to patients with HBeAg-negative chronic hepatitis B in Morocco. Patients will receive Pegasys 180 mcg subcutaneously weekly for 48 weeks and efficacy and safety will be recorded during treatment and for 24 weeks of follow-up.

Detailed description:

Arms: arm 1: Eligible participants with HI3vAg (a type of Hepatitis B surface antigen) negative chronic hepatitis B will be administered peginterferon alpha-2a (PEGASYS), 40kD, 180 micrograms (mcg) subcutaneously once weekly for 48 weeks. The untreated Follow-up will be for 24 weeks.
Interventions: intervention 1: Peginterferon alfa-2a [Pegasys]
Intervention descriptions: intervention 1: 180 mcg subcutaneously weekly, 48 weeks

Protocol documents:
Clinical trial NCT01791803
Conditions: Smoking Cessation
Keywords: Smoking cessation Tobacco abstinence hypnotherapy Nicotine replacement therapy
Sponsor: North Shore Medical Center
Start date: 2006-01-01; Completion date: 2009-05-01
Enrollment: 164 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Smoking-related cardiopulmonary diseases account for a large number of hospital admissions. We investigated the efficacy of hypnotherapy as an aid to a counseling-based smoking cessation program in improving quit rates of hospitalized smoking patients at 12 and 26 weeks after hospital discharge. We compared outcomes with hospitalized patients who received more conventional therapy, namely nicotine replacement therapy, or patients who decided to quit on their own. We also compared smoking cessation rates at 12 and 26 weeks after hospitalization among patients admitted with a cardiac or a pulmonary diagnosis.

Detailed description:
Hospitalized patients with a cardiopulmonary diagnosis who were contemplating quitting were recruited into 4 groups: Hypnotherapy, Nicotine replacement therapy (NRT), both hypnotherapy and NRT, and self-quit group. All patients received self-help brochures and in-hospital counseling. Intervention groups received more extensive counseling, free NRT supply for a month and/or a 90 minute hypnotherapy session within 2 weeks of discharge. They also had follow up telephone counseling at 1,2,4,8 and 12 weeks after discharge. 7 day prevalence of tobacco abstinence rates at 26 weeks after hospitalization were verified by self report and urinary Cotinine levels.

Arms: arm 1: Patients admitted with a cardiopulmonary illness received a 90 minute free hypnotherapy session within 2 weeks of discharge, and a standardized tape for smoking cessation and relaxation for continued use after the session. They also received self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after discharge. arm 2: Patients recieved a free one month supply of Nicotine replacement therapy to include patches and Gum, lozenges or sprays. Patients also received self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after hospitalization. arm 3: The group received similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nicotine replacement supplies for a month after discharge. arm 4: Patients were given brief counseling during hospitalization and will not be contacted until 26 weeks after hospitalization.
Interventions: intervention 1: hypnotherapy intervention 2: Nicotine
Intervention descriptions: intervention 1: One 90 minute session within 2 weeks of hospital discharge intervention 2: free one month supply after hospital discharge

Protocol documents:
Clinical trial NCT01798264
Conditions: Type 2 Diabetes
Sponsor: Intarcia Therapeutics
Start date: 2009-02-01; Completion date: 2009-05-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
evaluate the safety and tolerability of ITCA 650 in subjects with type 2 diabetes mellitus.

Detailed description:

Arms: arm 1: ITCA 650 (exenatide in DUROS) arm 2: ITCA 650 (exenatide in DUROS) arm 3: ITCA 650 (exenatide in DUROS) arm 4: ITCA 650 (exenatide in DUROS)
Interventions: intervention 1: ITCA 650 (exenatide in DUROS)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01950169
Conditions: Hip Fracture
Keywords: Hip fracture Nutritional supplement Bisphosphonates Bone mineral density Body composition
Sponsor: Karolinska Institutet
Start date: 2004-12-01; Completion date: 2009-05-01
Enrollment: 79 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study hypothesis is that nutritional supplementation together with bisphosphonates have a better preserving effect on bone mineral density (BMD) after hip fracture than bisphosphonates alone and that nutritional supplementation given postoperatively for 6 months preserve lean body mass in elderly hip fracture patients.

Detailed description:
Inclusion criteria: Men and women, ≥ 60 years of age with a recent fracture of the femoral neck or trochanter, admitted to any of the four University hospitals in Stockholm, Sweden. Patients are randomized into three groups by sealed enveloped technique in blocks by 12, thus assuring that each center had an equal distribution of patients in the three treatment groups. Patients randomly assigned and followed for 12 months. Each center with a doctor in charge and a trial nurse. The trial nurse in collaboration with the doctor are responsible of the randomization procedure and that blood samples are taken in the morning of the first weekday after inclusion at the ward and further that the dual-energy X-ray (DXA) and all estimates are done during hospital stay.The pharmacological treatment and nutritional supplementation starts as soon as the patients are circulatory stable, able to take food by mouth and are able to sit in an upright position one hour after taking the tablets.Patients are examined at baseline with a follow up at 6 and 12 months.

Arms: arm 1: 35 mg risedronate orally administered once weekly for 12 months and orally administered Calcium 1000 mg and 800 IU vitamin D3 daily for 12 months. Group B (bisphosphonate group) arm 2: Oral liquid nutritional supplement (600kcal and 40 gram protein/day) for 6 months after the hip fracture besides Risedronate and calcium and vitamin D3. Group BN (bisphosphonate and nutritional supplemented group) arm 3: An oral dose of 1000 mg Calcium and 800 IU vitamin D3 daily for 12 months after hip fracture. Group C (control)
Interventions: intervention 1: Risedronate intervention 2: Nutritional supplement intervention 3: Calcium and vitamin D3
Intervention descriptions: intervention 1: The bisphosphonate group (B) receive 35 mg risedronate (Optinate® Septimum) once weekly for 12 months and calcium (1000 mg) and vitamin D3 (800 IU) (Calcichew-D3®) daily for 12 months. intervention 2: The bisphosphonate and nutritional supplemented group (BN) receive 35 mg risedronate once weekly for 12 months plus nutritional supplement (Fresubin® protein energy drink) during the first six months following hip fracture and also calcium (1000 mg) and vitamin D3 (800 IU) daily for 12 months. intervention 3: The patients in the control group (C) receive orally administered calcium 1000 mg and 800 IU vitamin D3 (Calcichew-D3®) daily for 12 months.

Protocol documents:
Clinical trial NCT02133534
Conditions: Chronic Kidney Disease High Cholesterol
Keywords: Chronic kidney disease High cholesterol
Sponsor: Duke University
Start date: 2008-02-01; Completion date: 2009-05-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to see if patients with chronic kidney disease have endothelial cells that don't function properly, which is thought to be a marker for cardiovascular risk. Endothelial cells line the heart and blood vessels. The investigators will treat your high cholesterol with a cholesterol-lowering drug (atorvastatin, or Lipitor). They will determine if this cholesterol lowering drug improves subjects' cholesterol as well as the function of endothelial cells.

Detailed description:

Arms: arm 1: Subjects will be treated with atorvastatin 10 mg/day for 30 days. The study team will obtain one blood and urine sample at baseline prior to starting atorvastatin therapy, and again after 30 days of drug therapy. The study team will do ultrasound imaging of the arm in which a probe will be placed over the blood vessels to measure the diameter of the artery and how this changes after a blood pressure cuff is inflated and then deflated. Subjects will take one nitroglycerine tablet during the ultrasound imaging.
Interventions: intervention 1: Atorvastatin
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02169466
Conditions: Parkinson's Disease (PD)
Keywords: Parkinson's disease (PD) Opicapone BIA 9-1067
Sponsor: Bial - Portela C S.A.
Start date: 2009-01-01; Completion date: 2009-05-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg) on the levodopa pharmacokinetics when administered in combination with a single-dose of controlled-release levodopa 100 mg/benserazide 25 mg (Madopar HBS).

Detailed description:
Single centre, double-blind, randomized, placebo-controlled, crossover study with four consecutive single-dose treatment periods. The washout period between doses was to be at least10 days. On each treatment period (25, 50 and 100 mg BIA 9-1067 or placebo), after completion of pre-dose assessments, BIA 9-1067-Placebo was to be administered concomitantly with the dose of Madopar HBS; post-dose assessments were to be completed and subjects were to be discharged 72 h post-dose.

Arms: arm 1: Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo

BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.) arm 2: Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg

BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.) arm 3: Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg

BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.) arm 4: Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg

BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)
Interventions: intervention 1: BIA 9-1067 intervention 2: Placebo intervention 3: Madopar® HBS
Intervention descriptions: intervention 1: OPC, Opicapone intervention 2: PLC, Placebo intervention 3: controlled-release levodopa 100 mg/benserazide 25 mg

Protocol documents:
Clinical trial NCT02171611
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2009-03-01; Completion date: 2009-05-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To determine the relative bioavailability of 150 mg of dabigatran etexilate as pellets on food and of 150 mg of dabigatran etexilate as powder resolved in reconstitution solution, both with 150 mg of dabigatran etexilate as capsule in healthy volunteers

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Dabigatran etexilate pellets intervention 2: Dabigatran etexilate powder intervention 3: Dabigatran etexilate capsule
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents: