ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01421589
Conditions: Obese Growth Hormone Secretion Abnormality
Keywords: Growth hormone GH Obesity Mitochondrial function reduced growth hormone secretion
Sponsor: Massachusetts General Hospital
Start date: 2011-09-01; Completion date: 2013-03-01
Enrollment: 15 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Obesity is associated with reduced growth hormone (GH) secretion. Reduced GH secretion in obesity is associated with increased cardiovascular disease risk. However, it is not yet known how reduced GH increases cardiovascular disease risk in obesity. The investigators hypothesize that reduced GH contributes to dysfunction of the mitochondria. Therefore, the investigators hypothesize that treatment of obese subjects with reduced GH secretion with GH will improve mitochondrial function and that this improvement in mitochondrial function will contribute, in part, to the effects of GH to improve metabolic parameters in obesity. The investigators propose to study skeletal muscle mitochondria in obese subjects with reduced GH secretion using magnetic resonance spectroscopy and muscle biopsies before and after treatment with GH.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Growth hormone treatment
Intervention descriptions: intervention 1: Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.

Protocol documents:
Clinical trial NCT01426386
Conditions: Infertility
Sponsor: Ferring Pharmaceuticals
Start date: 2011-09-01; Completion date: 2013-03-01
Enrollment: 265 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial investigates the effects of several doses of FE 999049 in women undergoing IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection) treatment.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: FE 999049 intervention 2: Gonal - F
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01435174
Conditions: End-stage Renal Disease Cardiovascular Disease
Keywords: ranolazine end-stage renal disease pharmacokinetics cardiovascular disease
Sponsor: University of Michigan
Start date: 2011-10-01; Completion date: 2013-03-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
End-stage renal disease (ESRD) patients often develop cardiovascular complications, and cardiovascular disease is the leading cause of death in this population. Ranolazine's ability to treat angina without reducing heart rate or blood pressure makes it an important option for ESRD patients. The hemodialysis clearance of ranolazine is unknown. A single-dose pharmacokinetic study is needed to characterize ranolazine and its metabolites in ESRD patients on and off hemodialysis. Results of the proposed study will provide initial dosing estimates for a follow-up, multiple-dose pharmacokinetic study in this population.

Detailed description:

Arms: arm 1: End-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session.
Interventions: intervention 1: Ranolazine intervention 2: Pharmacokinetic Blood and Dialysate Sampling intervention 3: QT Interval
Intervention descriptions: intervention 1: A single dose of two oral ranolazine extended release 500 mg tablets intervention 2: Blood samples collected to assess ranolazine plasma and dialysate concentrations. intervention 3: Calculation of a QT interval will be performed throughout subject participation.

Protocol documents:
Clinical trial NCT01438814
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2011-11-01; Completion date: 2013-03-01
Enrollment: 689 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to investigate the impact of the combination therapy of linagliptin and metformin at submaximal doses in reduction of Glycosylated haemoglobin (HbA1c) and metformin pre-specified gastro-intestinal (GI) side effects in treatment naive patients of with type 2 diabetes mellitus.

Detailed description:

Arms: arm 1: patients to receive linagliptin +metformin QD arm 2: patients to receive metformin BID
Interventions: intervention 1: metformin placebo intervention 2: linagliptin placebo intervention 3: metformin intervention 4: metformin intervention 5: linagliptin
Intervention descriptions: intervention 1: metformin placebo tablets 500mg intervention 2: linagliptin placebo tablets 5mg intervention 3: metformin tablets 500mg intervention 4: metformin tablets 500 mg intervention 5: linagliptin tablets 5mg

Protocol documents:
Clinical trial NCT01440959
Conditions: Gastrointestinal Stromal Tumors
Keywords: This is a single-center prospective single-arm open-label phase II study
Sponsor: Asan Medical Center
Start date: 2011-09-01; Completion date: 2013-03-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
With discovery of KIT mutations and the advent of KIT tyrosine kinase inhibitor imatinib (GlivecTM, Novartis), there has been substantial improvement in overall survival in patients with advanced and/or metastatic gastrointestinal tumors (GIST). Recently, sunitinib (SuteneTM, Pfizer) showed activity as second-line therapy in GIST patients after failure with imatinib. However, virtually all patients will eventually progress or become intolerable after the first-line imatinib and the second-line sunitinib. Dovitinib (TKI258, Novartis) is a multi-kinase inhibitor. TKI258 is a potent inhibitor of the VEGFR 1, 2, and 3, FGFR1, 2 and 3, PDGFRβ, Kit, RET, TrkA, CSF 1R, and FLT3 with inhibitory concentration 50% (IC50s) of less than 40nM. Stem cell factor (SCF) also termed KIT ligand, or steel factor has been shown to modulate tumor angiogenesis. In cultured human endothelial cells and Kit expressing cancer cells, TKI258 inhibits VEGF- and SCF-stimulated mitogenesis. .

Detailed description:
It is well known that KIT and PDGFR which can be inhibited by TKI258 have a crucial role in the development and proliferation of GIST, and in general FGFR has an important role in angiogenesis and tumor proliferation in many cancers. We assume that TKI258 can be also effective in patients with GIST. The objective of this study is to evaluate the safety and activity of TKI258 given as salvage treatment for GIST after failure to standard imatinib and sunitinib.

Arms: arm 1: None
Interventions: intervention 1: dovitinib
Intervention descriptions: intervention 1: TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule

Protocol documents:
Clinical trial NCT01444651
Conditions: Cardiovascular Disease Insulin Resistance Glucose Intolerance Obesity
Keywords: Tadalafil Phosphodiesterase 5 Inhibitors Cyclic Guanylyl Monophosphate Pathway Pharmacologic Actions Vasodilator Agents Cardiovascular Agents Obesity Glycemic Traits Insulin Resistance Glucose Metabolism
Sponsor: Thomas J. Wang, MD
Start date: 2011-08-01; Completion date: 2013-03-01
Enrollment: 73 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to find out if tadalafil can help overweight and obese people metabolize blood sugar more efficiently. The investigators also want to find out if 20 mg/day of tadalafil for 3 months is safe to take without causing too many side effects. The investigators are plan to enroll 100 subjects at Massachusetts General Hospital (MGH).

Detailed description:
This study is examining changes in insulin resistance and glucose tolerance following 3 months of treatment with oral, once daily tadalafil.

The investigators primary hypotheses are that measurable decreases in insulin resistance (as measured by HOMA-IR) and increases in insulin sensitivity (as measured by the Matsuda index) will occur following 3 months of treatment with oral tadalafil 20 mg daily compared to placebo.

The investigators secondary hypotheses are that improvements in average glycemia (as measured by hemoglobin A1C), pancreatic beta cell function (as measured by the oral disposition index), and body composition (including weight, waist circumference, body mass index, and waist-hip ratio) will occur as a result of tadalafil-mediated changes in the cGMP pathway.

Arms: arm 1: 20 mg Tadalafil tablet taken by mouth once a day for 3 months arm 2: Placebo tablet taken by mouth once a day for 3 months
Interventions: intervention 1: Tadalafil intervention 2: Placebo
Intervention descriptions: intervention 1: 20 mg Tadalafil taken once a day for 3 months intervention 2: Placebo tablet taken by mouth once a day for 3 months

Protocol documents:
Clinical trial NCT01444924
Conditions: Gynecologic Cancer Post-operative Pain
Keywords: Pain control Gynecologic Oncology Surgery
Sponsor: University of Wisconsin, Madison
Start date: 2011-09-01; Completion date: 2013-03-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a single-center, randomized, placebo-controlled, double-blind clinical trial. The purpose of this study is to evaluate the impact of pre-operative transverses abdominis plane (TAP) blocks on post-operative analgesia in patients undergoing robotic surgery for gynecologic cancers.

Detailed description:

Arms: arm 1: TAP block with bupivicaine/epinephrine placed prior to surgery. arm 2: TAP block with placebo placed prior to surgery
Interventions: intervention 1: Bupivicaine intervention 2: Placebo
Intervention descriptions: intervention 1: The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis intervention 2: The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline.

Protocol documents:
Clinical trial NCT01445886
Conditions: Nail Psoriasis
Keywords: Nail Psoriasis Indigo Naturalis Indirubin Calcipotriol Nail Psoriasis Severity Index
Sponsor: Yin-ku Lin
Start date: 2011-01-01; Completion date: 2013-03-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to compare the efficacy and safety of indigo naturalis oil extract and calcipotriol solution in the treatment of psoriatic nails, to show that indigo naturalis oil extract may be a good choice for treating nail psoriasis, and potentially an effective alternative for those who do not respond well to traditional therapy.

Detailed description:
In the literature, the efficacy of traditional Chinese medicine in treating nail psoriasis is rarely reported. Recently, the investigators developed a new product, indigo naturalis oil extract, which worked well in nail disease. In our randomized, observer-blind, vehicle-controlled trial showed that indigo naturalis oil extract is effective and safe in treating nail psoriasis. This study aims to compare the efficacy and safety of indigo naturalis oil extract with calcipotriol solution in patients with nail psoriasis using controlled, bilateral comparison

The investigators will enroll 33 patients with nail psoriasis from the ambulatory department of Chang Gung Memorial Hospital. Indigo naturalis oil extract will be consistently applied on either the left or right affected nail folds, while calcipotriol will be applied on the opposite side, both twice daily for 24 weeks, allowing intra-patient comparison. The nails will be assessed by two dermatologists before treatment and at week 2, 4, 8, 12, 16, 20, 24.

Arms: arm 1: A 5-ml eye drop bottles contain indigo naturalis powder mixed with olive oil, and the concentration was 200 ug indirubin per ml. Each subject was asked to apply one to two drops (0.05 ml per drop) of the solution twice daily onto the nail folds, plus the hyponychium, of affected nails. The maximum period of treatment was 24 weeks or until there was complete clearing of their nail psoriasis. arm 2: Calcipotriol solution (Daivonex® scalp solution, calcipotriol 50 ug/ml) was purchased from LEO Pharmaceutical Products, Ltd. (Ballerupt, Denmark) and also distributed into 5-ml eye drop bottles for this trial.Each subject was asked to apply one to two drops (0.05 ml per drop) of the solution twice daily onto the nail folds, plus the hyponychium, of affected nails. The maximum period of treatment was 24 weeks or until there was complete clearing of their nail psoriasis.
Interventions: intervention 1: Indigo Naturalis Extract in Oil intervention 2: Calcipotriol Solution
Intervention descriptions: intervention 1: The participants applied indigo naturalis extract in oil topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 24 weeks. intervention 2: The participants applied calcipotriol solution topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 24 weeks.

Protocol documents:
Clinical trial NCT01446042
Conditions: Male Hypogonadism
Sponsor: Acerus Pharmaceuticals Corporation
Start date: 2011-09-01; Completion date: 2013-03-01
Enrollment: 306 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy (based on the pharmacokinetic profile of testosterone) and safety of TBS-1 in the treatment of hypogonadal men

Detailed description:
This study is a 4 Period study consists of 16 visits with overnight clinic stays that span over year to help determine the efficacy of TBS-1 gel administered twice daily (b.i.d) and three times daily (t.i.d)

In addition, this study will investigate the safety and tolerability of TBS-1 after 90, 180 and 360 days of treatment.

Arms: arm 1: 5.5 mg per nostril of 4.5% TBS-1 BID arm 2: 5.5 mg per nostril of 4.5% TBS-1 TID
Interventions: intervention 1: Testosterone intervention 2: Testosterone
Intervention descriptions: intervention 1: Intranasal testosterone intervention 2: Intranasal testosterone

Protocol documents:
Clinical trial NCT01454791
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis diclofenac subcutaneous injection glatiramer acetate Copaxone
Sponsor: Brown, Theodore R., M.D., MPH
Start date: 2011-01-01; Completion date: 2013-03-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the effect of Diclofenac Sodium Topical Gel (DSTG) on injection site reaction following self-administer glatiramer acetate in people with Multiple Sclerosis.

Detailed description:
A 4 week study with active or placebo medication at randomization and switch treatment at 2-week crossover visit (2 weeks on each arm). There will be a total of 3 visits to the clinic. Subjects will receive instruction on how to apply the DSTG/placebo at the injection site and keep a daily injection site reaction diary.

Arms: arm 1: 1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active). arm 2: 1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active).
Interventions: intervention 1: diclofenac sodium topical gel intervention 2: Placebo
Intervention descriptions: intervention 1: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks either preceded by or followed by two weeks of placebo intervention 2: a placebo gel is applied 1-4 times per day for two weeks.

Protocol documents:
Clinical trial NCT01456130
Conditions: Diabetes Mellitus
Sponsor: Takeda
Start date: 2011-11-01; Completion date: 2013-03-01
Enrollment: 67 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of alogliptin as an add-on to a rapid-acting insulin secretagogue (medicine that stimulates insulin release) in type 2 diabetic patients with inadequate blood glucose control despite treatment with a rapid-acting insulin secretagogue as well as diet and exercise therapies.

Detailed description:
One alogliptin 25 mg tablet was orally administered once daily before breakfast for up to 52 weeks.

The dose of alogliptin was adjusted according to the severity of the participant's renal dysfunction based on serum creatinine (SCr) levels. Participants with moderate renal dysfunction (SCr, \>1.4 - ≤2.4 mg/dL for men and \>1.2 - ≤ 2.0 mg/dL for women) received alogliptin 12.5 mg tablets.

Arms: arm 1: Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.
Interventions: intervention 1: Alogliptin intervention 2: Rapid-acting insulin secretagogue
Intervention descriptions: intervention 1: Alogliptin tablets intervention 2: Either of the following commercially available rapid-acting insulin secretagogues as prescribed by the Investigator: (i) Nateglinide: Dose: 30 mg tablet or 90 mg tablet (ii) Mitiglinide calcium hydrate: Dose: 5 mg tablet or 10 mg tablet

Protocol documents:
Clinical trial NCT01458275
Conditions: Seasonal Allergic Rhinitis
Keywords: Seasonal Allergic Rhinitis Ciclesonide Ciclesonide Nasal Aerosol
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2011-11-01; Completion date: 2013-03-01
Enrollment: 847 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 2-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and premenarchal female subjects 6 to 11 years-old diagnosed with SAR.

Detailed description:
This is a 2-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and premenarchal female subjects 6 to 11 years-old diagnosed with SAR.

This study will consist of the following:

Screening, Single-blind Placebo Run-in period, Double-blind Treatment period (during this period, subjects will be randomized to double-blind treatment with either ciclesonide nasal aerosol 37 mcg or 74 mcg or placebo for 2 weeks of treatment) and Follow-up. The total duration of subject participation will be approximately 2 months.

Arms: arm 1: ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg arm 2: ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg arm 3: None
Interventions: intervention 1: Ciclesonide nasal aerosol 37 mcg intervention 2: ciclesonide nasal aerosol 74 mcg intervention 3: Placebo
Intervention descriptions: intervention 1: ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg intervention 2: ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg intervention 3: Placebo - one actuation per nostril

Protocol documents:
Clinical trial NCT01464931
Conditions: Renal Impairment
Sponsor: Amgen
Start date: 2011-11-01; Completion date: 2013-03-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective was to evaluate the incidence of clinically significant hypocalcemia following multiple 120 mg subcutaneous doses of denosumab in patients with severe chronic kidney disease (CKD) and CKD on dialysis

Detailed description:

Arms: arm 1: Participants received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
Interventions: intervention 1: Denosumab
Intervention descriptions: intervention 1: Adminstered by subcutaneous injection

Protocol documents:
Clinical trial NCT01468350
Conditions: Cerebral Palsy (CP)
Sponsor: Acorda Therapeutics
Start date: 2011-12-01; Completion date: 2013-03-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A double-blind, placebo-controlled, crossover study in subjects with cerebral palsy (CP) to evaluate the safety and tolerability and the effect of dalfampridine extended release (ER) tablets on sensorimotor function

Detailed description:

Arms: arm 1: Each subject randomized to the AB arm will receive a single witnessed dose of (A) dalfampridine-ER 10 mg, and a single witnessed dose of (B) placebo, two days apart arm 2: Each subject randomized to the BA arm will receive a single witnessed dose of (B) placebo, and a single witnessed dose of (A) dalfampridine-ER 10 mg, two days apart arm 3: Each subject randomized to the AB arm will receive multiple doses of (A) dalfampridine-ER 10mg and multiple doses of (B) placebo arm 4: Each subject randomized to the BA arm will receive multiple doses of (B) placebo, and multiple doses of (A) dalfampridine-ER 10mg
Interventions: intervention 1: dalfampridine-ER 10mg intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01474551
Conditions: Melanoma
Keywords: Vemurafenib skin cancer Stage IV advanced stage III 11-091
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2011-11-01; Completion date: 2013-03-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out what effects, good and/or bad, vemurafenib has on the patient and the melanoma. Specifically, the investigators want to know how well vemurafenib shrinks melanoma. The investigators also want to find out how well vemurafenib can improve how well the patient functions.

Detailed description:

Arms: arm 1: This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery.
Interventions: intervention 1: vemurafenib
Intervention descriptions: intervention 1: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long.

Protocol documents:
Clinical trial NCT01475071
Conditions: Actinic Keratoses
Sponsor: Galderma R&D
Start date: 2012-03-01; Completion date: 2013-03-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The main objective of this study is to compare efficacy and safety of Metvix® natural daylight photodynamic therapy with those of Metvix® conventional photodynamic therapy with Aktilite™ lamp in subjects with mild actinic keratoses (intra-individual comparison).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Metvix and natural daylight PDT intervention 2: Metvix and conventional PDT
Intervention descriptions: intervention 1: Methyl aminolevulinate, cream 160mg/g.One session at baseline and a second session administration at week 12 for lesions showing non-complete response and new lesions on target area. intervention 2: Methyl aminolevulinate, cream, 160mg/g. One session at baseline and a second session administration at week 12 for lesions showing non-complete response and new lesions on target area.

Protocol documents: