ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00765336
Conditions: Human Volunteer
Keywords: Spermatogenesis in Healthy Males
Sponsor: Medicis Pharmaceutical Corporation
Start date: 2006-11-01; Completion date: 2009-01-01
Enrollment: 180 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Researchers want to find out how Minocycline Extended-Release Tablets affect sperm-production in healthy males.

The study will include Minocycline Extended-Release Tablets, a new once-daily formulation of minocycline, compared with a placebo or inactive pill.

Approximately 170 healthy adult males will be assigned by chance (like flipping a coin) to 2 treatment groups with approximately 85 subjects per group. You will be treated with either Minocycline Extended-Release Tablets or placebo once daily. Screening will occur within 14 days prior to the first dose of study drug.

Required study activities include:

* Written informed consent
* Weight
* Two semen collections within 48-72 hours of one another at the screening visit and Days 84,112, 140, and 168
* Blood draws at the screening visit and Days 84, 112, 140, and 168
* Genital examination (excluding prostate) at screening and at the Day 84 and Day 112 visits
* Medical history

You will continue in the treatment phase of the study for 12 weeks.

You will return to the clinic 4 weeks and 8 weeks after completion of the treatment phase of the study, with the final study visit approximately 12 weeks after the last dose.

Participation will be for 24-weeks.

Up to 10 investigational sites will enroll subjects into the study.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: minocycline extended release intervention 2: Placebo
Intervention descriptions: intervention 1: 1 mg/kg extended release minocycline HCL, once daily for 84 days. intervention 2: placebo comparator for 1 mg/kg extended release minocycline HCL, once daily for 84 days.

Protocol documents:
Clinical trial NCT00803686
Conditions: Phase 1 Pharmacodynamic Study
Sponsor: Tarsa Therapeutics, Inc.
Start date: 2008-12-01; Completion date: 2009-01-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is being conducted to assess the plasma CTx-1 concentrations when dosing is at night and to compare these results with those obtained with a placebo control and with commercially available nasal calcitonin.

Detailed description:
Timing of the dose of recombinant salmon calcitonin (rsCT) is important in effecting reduction of osteoclast activity. It is theorized that a dose administered before bedtime will be more effective than a dose administered in the morning. See protocol summary for information.

Arms: arm 1: Intervention: Oral rsCT tablet given once 4 hours after evening meal. arm 2: Intervention: Oral placebo tablet matching the oral rsCT tablet, given once 4 hours after evening meal arm 3: Intervention: Oral rsCT tablet given once 2 hours after evening meal. arm 4: Intervention: Part 2 Open label. Fortical (rsCT) nasal spray given once 2 hours after evening meal
Interventions: intervention 1: Oral rsCT tablet intervention 2: Oral Placebo Tablet intervention 3: Oral rsCT tablet intervention 4: Fortical (rsCT) nasal spray
Intervention descriptions: intervention 1: On Study Day 1, subjects will be given their assigned treatment, based on one of two randomly ordered treatment sequences, at 10 PM (22:00). On Visit 3, subjects will return for administration of the second treatment with a minimum of 7 days washout interval between study drug administrations. On Visit 4, subjects will return for administration of third treatment of rsCT, either oral rsCT tablets or Fortical (rsCT) nasal spray. Interventions are described in Intervention Name, Other Names and in Intervention Description. intervention 2: Part 1, Double blind oral placebo tablet given once 4 hours after evening meal. intervention 3: Part 2, Open-label, oral rsCT tablet given once 2 hours after the evening meal. intervention 4: Intervention: Open label, Fortical nasal spray given once 2 hours after the evening meal.

Protocol documents:
Clinical trial NCT00828295
Conditions: Postoperative Nausea and Vomiting
Keywords: Postoperative Nausea and Vomiting palonosetron pediatric
Sponsor: Helsinn Healthcare SA
Start date: 2008-08-01; Completion date: 2009-01-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the study is to assess the safety and efficacy of two doses of IV palonosetron each administered as a single dose for the prevention of postoperative nausea and vomiting through 72 hours postoperatively in children aged 28 days up to 16 years inclusive undergoing surgical procedures requiring general endotracheal inhalation anesthesia.

Detailed description:

Arms: arm 1: Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg) arm 2: Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)
Interventions: intervention 1: palonosetron intervention 2: palonosetron
Intervention descriptions: intervention 1: palonosetron IV 1 mcg/kg intervention 2: palonosetron 3mcg/kg IV

Protocol documents:
Clinical trial NCT00828464
Conditions: Hand Dermatosis
Keywords: Dermatosis, Dermatitis, Dry skin, Irritated skin
Sponsor: Stiefel, a GSK Company
Start date: 2008-10-01; Completion date: 2009-01-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to assess the safety, efficacy and tolerability of Clobetasol propionate foam in subjects with chronic dermatitis.

Detailed description:
The study is being conducted in order to obtain safety, efficacy and tolerability data for Clobetasol propionate foam in the treatment of chronic dermatitis. The subjects must have mild to moderate disease based on the Investigator's assessment at baseline.

Arms: arm 1: All subjects receive clobetasol propionate
Interventions: intervention 1: clobetasol propionate
Intervention descriptions: intervention 1: Clobetasol propionate. The study product will be applied topically twice a day (morning and evening) for 14 days of treatment.

Protocol documents:
Clinical trial NCT00832091
Conditions: Venous Stasis Ulcers
Keywords: Venous Stasis Ulcers venous insufficiency leg ulcers Thymosin Beta 4 Laminin-5
Sponsor: RegeneRx Biopharmaceuticals, Inc.
Start date: 2006-07-01; Completion date: 2009-01-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 administered topically in patients with Venous Stasis ulcers

Detailed description:
The purpose of this double-blind, placebo-controlled, dose-response study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 (Tβ4), administered topically, in patients with Venous Stasis (VS) ulcers. VS ulcers develop on the ankle or lower leg in patients with chronic vascular disease. In these patients, blood flow in the lower extremities is impaired, leading to edema (swelling) and mild redness and scaling of the skin that gradually progress to ulceration. Tβ4 is a synthetically-produced copy of a naturally occurring 43 amino acid peptide that has wound healing and anti-inflammatory properties and can up-regulate the expression of laminin-5.

Arms: arm 1: There are 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There were 3 concentrations used for topical administration to the active drug groups: 0.01% weight/weight (w/w), 0.03% w/w, and 0.1% w/w thymosin beta 4 gel applied once daily for up to 84 days arm 2: There were 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There was one concentration of placebo gel for topical administration to the placebo group. The concentration was 0.0% weight/weight (w/w) thymosin beta 4 gel applied once daily for up to 84 days
Interventions: intervention 1: Thymosin Beta 4 intervention 2: Placebo
Intervention descriptions: intervention 1: There were 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There were three concentrations of gel used for topical administration to the active groups: 0.01% weight/weight (w/w), 0.03% w/w, and 0.1% w/w thymosin beta 4 gel applied once daily for up to 84 days intervention 2: There were 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There was one concentration of placebo gel for topical administration to the placebo group. The concentration was 0.0% weight/weight (w/w) thymosin beta 4 gel applied once daily for up to 84 days

Protocol documents:
Clinical trial NCT00841776
Conditions: Acne
Keywords: Acne Vulgaris Acne
Sponsor: Stiefel, a GSK Company
Start date: 2007-08-01; Completion date: 2009-01-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine the development of microbial resistance when using one of two topical acne therapies for the treatment of facial acne vulgaris.

Detailed description:
To investigate the development of microbial resistance when using one of two topical acne therapies for the treatment of moderate to moderately severe facial acne vulgaris. Clinical efficacy and tolerability will be assessed.

Arms: arm 1: Clindamycin and benzoyl peroxide gel arm 2: Clindamycin and tretinoin gel
Interventions: intervention 1: Duac intervention 2: Ziana gel
Intervention descriptions: intervention 1: Clindamycon and benzoyl peroxide topical gel once a day for 12 weeks intervention 2: Clindamycin and tretinoin gel once a day for 12 weeks.

Protocol documents:
Clinical trial NCT00912002
Conditions: Type 2 Diabetes
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-10-01; Completion date: 2009-01-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A single dose, open label study to characterize the routes of elimination and determine the mass balance of MK-0941. A single 40 mg dose of MK-0941 will be given orally to male participants with type 2 diabetes. After drug administration, blood, urine, and fecal samples will be collected to determine relative quantities of 14C-labeled MK-0941.

Detailed description:

Arms: arm 1: MK-0941
Interventions: intervention 1: MK-0941
Intervention descriptions: intervention 1: A single dose of 40 mg of \[14C\]MK-0941 (160 µCi), taken orally as eight 5-mg capsules

Protocol documents:
Clinical trial NCT00938366
Conditions: Multiple Sclerosis
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2008-01-01; Completion date: 2009-01-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of the study is to assess the influence of pantoprazole on the pharmacokinetic profile of cladribine, especially in terms of extent of absorption of cladribine since pH-modifying drug may potentially affect the stability of cladribine and thereby its bioavailability

Detailed description:

Arms: arm 1: Subjects will receive a single dose of cladribine10 milligram (mg) orally on Day 1. After a wash out period of 10-25 days, subjects will receive pantoprazole 40 mg orally for 2 consecutive days. On Day 2 of the pantoprazole administration, a single dose of cladribine 10 mg will be administered orally 3 hours after the second pantoprazole dose. arm 2: Subjects will receive pantoprazole 40 mg orally for 2 consecutive days. On Day 2 of the pantoprazole administration, a single dose of cladribine 10 mg will be administered orally 3 hours after the second pantoprazole dose. After a wash out period of 10-25 days, subjects will receive a single dose of cladribine 10 mg orally.
Interventions: intervention 1: Cladribine intervention 2: Pantoprazole
Intervention descriptions: intervention 1: Subjects will receive two single doses of 10 mg cladribine orally in either first or second intervention period followed by a washout period of 10-25 days. intervention 2: Subjects will receive a pantoprazole 40 mg orally for 2 consecutive days either in first or second intervention period.

Protocol documents:
Clinical trial NCT00981227
Conditions: Postherpetic Neuralgia
Keywords: pain herpetic neuralgia
Sponsor: Bial - Portela C S.A.
Start date: 2007-11-01; Completion date: 2009-01-01
Enrollment: 567 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to assess the efficacy of eslicarbazepine acetate (ESL) as therapy for patients with post-herpetic neuralgia.

Detailed description:

Arms: arm 1: ESL 400 mg twice-daily arm 2: ESL 800 mg once-daily arm 3: ESL 600 mg twice daily arm 4: ESL 1200 mg once daily arm 5: ESL 800 mg twice daily arm 6: placebo
Interventions: intervention 1: Eslicarbazepine acetate intervention 2: Placebo
Intervention descriptions: intervention 1: Scored tablets intervention 2: oral route

Protocol documents:
Clinical trial NCT01028391
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-09-01; Completion date: 2009-01-01
Enrollment: 317 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A 30-week extension to a 24-week study assessing the hemoglobin A1c (HbA1c)- and fasting plasma glucose (FPG)-lowering efficacy of the combination of sitagliptin and pioglitazone in patients with type 2 diabetes mellitus (T2DM) with inadequate glycemic control.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Sitagliptin 100 mg q.d.+ Pioglitazone 45 mg q.d. intervention 2: Pioglitazone 45 mg q.d. + Sitagliptin 100 mg placebo q.d. intervention 3: Metformin
Intervention descriptions: intervention 1: Patients will receive combination therapy with blinded sitagliptin 100 mg q.d. (q.d. = once daily) and open-label pioglitazone 45 mg q.d. during the up to 30 week extension study. Sitagliptin 100 mg q.d. and pioglitazone 45 mg q.d. will be administered as oral tablets. intervention 2: Patients will receive placebo to match sitagliptin 100 mg q.d. (blinded) and open-label pioglitazone 45 mg q.d. during the up to 30 week extension study. The placebo to match sitagliptin 100 mg q.d. (blinded) and open-label pioglitazone 45 mg q.d. will be administered as oral tablets. intervention 3: Patients not meeting specific glycemic goals during the 30-week extension study will receive open-label metformin at a dose determined by the investigator.

Protocol documents:
Clinical trial NCT01033773
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus Uncontrolled hyperglycemia Emergency Department
Sponsor: Medstar Health Research Institute
Start date: 2007-09-01; Completion date: 2009-01-01
Enrollment: 86 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To demonstrate that a focused Emergency Department (ED) intervention for uncontrolled hyperglycemia enables safe and effective glycemic management and reduces emergency room re-visits. We assessed hypoglycemia BG \< 60mg/dL; change in mean blood glucose and A1C, and ED revisits for hyperglycemia.

Detailed description:
Patients with BG \> 200mg/dL presenting to an urban tertiary care hospital ED were enrolled in a 4 week prospective intervention with historic self-controls. Subjects returned at 12-72 hours, 2 and 4 weeks. Diabetes medications (including sulfonylureas, metformin and/or insulin) were initiated and/or adjusted at each visit using the intervention algorithm per presenting blood glucose and prior diabetes medications. Survival skills self-management education and navigation to outpatient services were provided.

Arms: arm 1: All enrolled patients received the intervention. There was no comparative arm. The analysis was done as pre and post.
Interventions: intervention 1: Antihyperglycemic medication guideline for management of uncontrolled hyperglycemia presenting to the ED using metformin, sulfonylurea and/or insulin intervention 2: Diabetes survival skills self-management education
Intervention descriptions: intervention 1: Diabetes medications (including sulfonylureas, metformin and/or insulin) were initiated and/or adjusted at each visit using the intervention algorithm per presenting blood glucose and prior diabetes medications. intervention 2: Survival skills DSME based upon current JCAHO and ADA joint recommendations for persons with diabetes prior to discharge to the outpatient setting was initiated in the ED and continued at the follow-up encounters.

Protocol documents:
Clinical trial NCT01101308
Conditions: Healthy
Keywords: Healthy subjects Opioid Healthy volunteers
Sponsor: Purdue Pharma LP
Start date: 2008-07-01; Completion date: 2009-01-01
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10 mg) manufactured at the Totowa, NJ facility relative to the formulation (10 mg) manufactured at the Wilson, NC facility in the fasted state.

Detailed description:
Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in the relief of moderate to severe malignant and non-malignant pain.

Arms: arm 1: Reformulated OXY 10 mg (Totowa) x 1 dose arm 2: Reformulated OXY 10 mg (Wilson) x 1 dose
Interventions: intervention 1: Reformulated OXY (Totowa) (oxycodone HCl) intervention 2: Reformulated OXY (Wilson) (oxycodone HCl)
Intervention descriptions: intervention 1: Reformulated OXY 10-mg tablet (Totowa) x 1 dose taken in the fasted state. intervention 2: Reformulated OXY 10-mg tablet (Wilson) x 1 dose taken in the fasted state.

Protocol documents:
Clinical trial NCT01143688
Conditions: Asthma Placebo Effects
Sponsor: Brigham and Women's Hospital
Start date: 2005-01-01; Completion date: 2009-01-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The investigators hypothesize that different placebos will have different effects on subjective and objective asthma outcomes compared with actual therapy and natural history. .

Subjects with asthma are randomly treated with placebo inhaler, placebo acupuncture, albuterol inhaler, or "no treatment" in random order, on three different occasions each. At each of the 12 visits, spirometry is performed repeatedly over 2 hours. Maximum FEV1 achieved and an 11-point, self-reported scale of improvement are examined.

Detailed description:

Arms: arm 1: albuterol arm 2: placebo arm 3: placebo
Interventions: intervention 1: albuterol intervention 2: placebo inhaler intervention 3: placebo acupuncture
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01180296
Conditions: Preterm Birth
Keywords: Preterm birth, prevention, progesterone, oral
Sponsor: Fetal Medicine Foundation
Start date: 2006-11-01; Completion date: 2009-01-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate whether daily oral micronized progesterone is effective in preventing recurrent spontaneous preterm birth (RSPB) and whether micronized progesterone use increases maternal serum progesterone levels.

Detailed description:
To evaluate whether 400 mg daily oral micronized progesterone from 16 to 34 weeks' is effective in preventing recurrent spontaneous preterm birth (RSPB) and whether micronized progesterone use increases maternal serum progesterone levels.

Arms: arm 1: Oral Micronized Progesterone arm 2: Identical Placebo Tablet
Interventions: intervention 1: oral micronized progesterone intervention 2: Identical Placebo tablet
Intervention descriptions: intervention 1: oral micronized progesterone = 400 mg oral micronized progesterone nightly from 16 to 34 weeks intervention 2: Identical Placebo tablet = placebo taking nightly from 16 to 34 weeks

Protocol documents:
Clinical trial NCT01302483
Conditions: Dental Anesthesia Efficacy
Sponsor: St. Renatus, LLC
Start date: 2008-12-01; Completion date: 2009-01-01
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to determine the safety and efficacy of Kovacaine Mist (3% tetracaine HCl with 0.05% oxymetazoline HCl) for anesthesia of the maxillary teeth for dental procedures.

Detailed description:
The primary objective of this single-center, randomized, double-blind, active-controlled, parallel-group study was to determine if Kovacaine Mist provided anesthesia of the maxillary teeth sufficient for the performance of dental procedures. Secondary objectives included a determination of whether Kovacaine Mist provided anesthesia of the soft tissue and to evaluate the safety and tolerability of Kovacaine Mist and sham injection as compared to sham nasal spray and 2% lidocaine hydrochloride with 1:100,000 epinephrine submucosal injection and as determined by changes in vital signs and reports of side effects and adverse events.

Arms: arm 1: 3% tetracaine HCL with 0.05% oxymetazoline HCL - Delivered via 3 sprays (100 uL) in each nostril arm 2: .5 to 1 catridge of 2% lidocaine HCL with 1:100,000 epinephrine
Interventions: intervention 1: 3% tetracaine HCL with 0.05% oxymetazoline HCL intervention 2: Lidocaine Injection
Intervention descriptions: intervention 1: 1 sham injection along with 3 sprays of Kovacaine Nasal Spray in each nostril; a 4-minute interval between every set of sprays. The total dose of 3% tetracaine HCL with 0.05% oxymetazoline HCL was 18 mg/0.3 mg. intervention 2: Each subject received both an injection along with 3 sprays of isotonic saline sham in each nostril; a 4-minute interval between every set of sprays.

Protocol documents:
Clinical trial NCT01823289
Conditions: Pulmonary Fungal Infection
Keywords: Invasive Pulmonary Fungal Infection Itraconazole
Sponsor: Xian-Janssen Pharmaceutical Ltd.
Start date: 2007-06-01; Completion date: 2009-01-01
Enrollment: 71 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of itraconazole sequential therapy (intravenous injection/oral solution) in participants with invasive pulmonary fungal infections (\[IPFI\]; lung diseases caused by fungal infection).

Detailed description:
This is an open-label (all people know the identity of the intervention), single arm, multicenter (when more than one hospital or medical school team work on a medical research study) study to evaluate the efficacy and safety of itraconazole sequential therapy in participants with IPFI. The study duration will be 4 to 6 weeks. The treatment will be divided into the intravenous (into a vein) injection period and the oral solution administration (giving) period. During the intravenous injection period 200 milligram (mg) twice daily loading dose (large initial dose) will be given for first 2 days, 200 mg once daily for the subsequent 12 days. Then sequential itraconazole oral solution 200 mg twice daily will be given as maintenance therapy (treatment designed to help the original primary treatment to succeed) for 2-4 weeks. Participant's clinical, mycological and comprehensive efficacy will be assessed at Week 6. Participants' safety will be monitored throughout the study.

Arms: arm 1: None
Interventions: intervention 1: Itraconazole
Intervention descriptions: intervention 1: Itraconazole 200 milligram (mg) intravenous injection will be given twice daily for first 2 days, 200 mg once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily will be given for 2 to 4 weeks.

Protocol documents: