ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02210689
Conditions: BACTERIAL VAGINOSIS Signs and Symptoms to be Evaluated and Recorded Include Vaginal Discharge Color, Odor, and Consistency Vulvovaginal Itching and Irritation (Subjective) Absent, Mild, Moderate, or Severe Vulvovaginal Inflammation (Objective) Absent, Mild, Moderate, or Severe
Sponsor: Actavis Inc.
Start date: 2014-01-01; Completion date: 2014-12-01
Enrollment: 604 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing Clindamycin phosphate vaginal cream 2% (Watson Laboratories, Inc.) to Clindesse® (Ther-Rx™, Clindamyin Phosphate Vaginal Cream 2%) and both active treatments to a placebo control in the treatment of bacterial vaginosis in non-pregnant women.

Detailed description:
The study treatment period will be 1 day. Subject participation is 22-30 days. Expected study duration is 10 to 12 months. The study will enroll in up to 30 clinical sites.

Test Product: One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing approximately 100 mg of clindamycin phosphate vaginal cream 2% (Watson Laboratories, Inc.)

Reference Product: One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing approximately 100 mg of Clindesse® (clindamycin phosphate vaginal cream 2% ) (Ther-Rx™)

Placebo Control: One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing vehicle of the test product (Watson Laboratories, Inc.)

Dose and Mode A single applicator of investigational product cream will be administered of Administration once intravaginally at any time of the day. The subject participation is 22-30 days (drug administration for 1 day).

Arms: arm 1: One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing approximately 100 mg of clindamycin phosphate vaginal cream 2% (Watson Laboratories, Inc.) arm 2: One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing approximately 100 mg of Clindesse® (clindamycin phosphate vaginal cream 2% ) (Ther-Rx™) arm 3: One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing vehicle of the test product (Watson Laboratories, Inc.)
Interventions: intervention 1: clindamycin phosphate vaginal cream 2% intervention 2: placebo
Intervention descriptions: intervention 1: None intervention 2: vehicle used as placebo

Protocol documents:
Clinical trial NCT02215954
Conditions: Colon Cleansing in Preparation for Colonoscopy
Sponsor: Ferring Pharmaceuticals
Start date: 2014-09-01; Completion date: 2014-12-01
Enrollment: 637 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To demonstrate non inferiority of a) "FE 999169 Split Dosing Schedule" (one dose on the day before and the second dose on the day of colonoscopy) and b) "FE 999169 Day Before Dosing Schedule" (two doses on the day before colonoscopy) to " Niflec On the Day Dosing Schedule" in subjects requiring colonoscopy.

Detailed description:
This was a phase III, randomized, assessor-blinded, parallel-arm, multicenter, study in Japanese patients. Patients, who signed an informed consent and fulfilled all screening criteria, were randomized in a 1:1:1 ratio to one of the following 3 treatment groups: "FE 999169 Split Dosing Schedule", "FE 999169 Day Before Dosing Schedule" and " Niflec On the Day Dosing Schedule" in subjects requiring colonoscopy.

Arms: arm 1: One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy arm 2: Two sachets on the day before colonoscopy arm 3: One to two pack(s) on the day of colonoscopy
Interventions: intervention 1: FE 999169 intervention 2: Niflec
Intervention descriptions: intervention 1: FE 999169 is a white crystalline powder for oral solution. Each sachet (16.1 g) contains sodium picosulfate hydrate 10 mg, magnesium oxide 3.5 g and anhydrous citric acid 12 g as well as orange flavour, potassium bicarbonate and sodium saccharin as excipients. FE 999916 is dissolved by mixing the contents of the sachet with approximately 150mL of cold water in a cup before administration. intervention 2: Niflec is a white-yellowish powder for oral solution. Each plastic sachet (137.155 g) contains sodium chloride 2.93 g, potassium chloride 1.485 g, sodium bicarbonate 3.37 g and sodium sulfate anhydrous 11.37 g, as well as macrogol 4000, saccharin sodium hydrate, flavour as excipients. Niflec is dissolved in water to make approximately 2 L of solution before administration.

Protocol documents:
Clinical trial NCT02221947
Conditions: Alzheimer's Disease
Keywords: Alzheimer's bryostatin PKC epsilon
Sponsor: Neurotrope Bioscience, Inc.
Start date: 2014-06-01; Completion date: 2014-12-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is being done to evaluate the safety, tolerability and potential effectiveness of a new investigational drug, bryostatin 1, in patients with Alzheimer's disease (AD).

Detailed description:
This study is a single center, randomized, double-blind, placebo-controlled, parallel groups trial in patients with AD. Each subject enrolled in the trial will be randomized to receive a single IV dose of 0 (placebo) or 25 μg/m2 bryostatin. A total of 15 subjects (5 in the placebo arm and 10 in the treatment arm) will be enrolled in the study. The study consists of screening evaluations and on study evaluations divided into two segments, an inpatient segment and an outpatient segment. The four-day inpatient segment will consist of baseline evaluations and a 1-hour IV infusion of study drug followed by evaluations at multiple evaluations over the first 72 hrs post dose. During the outpatient segment, patients will be followed for AEs and have a final evaluation at 2 weeks post dose and a 4-week telephone safety follow up. Evaluations will include safety, efficacy, pharmacokinetics, and pharmacodynamics as assessed by PKC activity

Arms: arm 1: single dose of 25 μg/m2 bryostatin, intravenous infusion over 1 hour arm 2: single dose of placebo, intravenous infusion over 1 hour
Interventions: intervention 1: Bryostatin 1 intervention 2: Placebo
Intervention descriptions: intervention 1: 25 μg/m2 bryostatin 1, single dose via intravenous infusion over 1 hour. intervention 2: Placebo, single dose via intravenous infusion over 1 hour.

Protocol documents:
Clinical trial NCT02223065
Conditions: Type 2 Diabetes Mellitus
Sponsor: AstraZeneca
Start date: 2014-09-01; Completion date: 2014-12-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to demonstrate bioequivalence of coadministered drugs on healthy subjects.

Detailed description:

Arms: arm 1: Single oral dose of saxagliptin tablet coadministered with dapagliflozin tablet arm 2: Single oral dose of FDC (fixed-dose combination) tablet
Interventions: intervention 1: Saxagliptin intervention 2: Dapagliflozin
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02223351
Conditions: Healthy
Keywords: HSV HIV Herpes volunteers drug-drug interaction
Sponsor: Maruho Europe Limited
Start date: 2014-09-01; Completion date: 2014-12-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
ASP2151 is an experimental treatment for herpes. HIV infected people are susceptible to contracting other infections because of their compromised immune system. As HIV patients will be taking drugs to treat the virus this study aims to see if ASP2151 would interact with one of the drugs that is commonly prescribed to HIV patients (ritonavir).

Detailed description:

Arms: arm 1: 400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir arm 2: 1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir
Interventions: intervention 1: ASP2151 intervention 2: ritonavir
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02227485
Conditions: Gingivitis
Keywords: Gingivitis Diabetes mellitus Medicine, Traditional Herbal medicine Punica granatum
Sponsor: Shiraz University of Medical Sciences
Start date: 2014-07-01; Completion date: 2014-12-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a triple-blinded randomized clinical trial to evaluate the effect of an Iranian traditional mouth rinse (Punica granatum Pleniflora or "Golnaar" mouthrinse) on treatment of diabetic gingivitis and compare it with chlorhexidine (0.2%).

Detailed description:
Among diabetic patients who refer to Motahhari clinic of Shiraz University of Medical Sciences 80 volunteers who have gingivitis and aged between 20 to 65 years old and fulfill other inclusion criteria, are randomly assigned to intervention or control groups. All of the patients will undergo a training panel about mouth hygiene and receive a pack of a toothbrush, a toothpaste, a dental floss and a mouth rinse. They are asked to return after 2 weeks for the second evaluation and taking tooth bleaching. The demographic and general information of all participants are taken and the primary outputs (plaque index and bleeding on probe) are measured at the beginning, after 2 weeks and after 4 weeks. All the examinations are done by one trained person and patients, practitioner and statistical analyser are blind to the interventions.

Arms: arm 1: Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse. arm 2: Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Interventions: intervention 1: Punica granatum Pleniflora (Golnaar) mouth rinse intervention 2: Chlorhexidine (0.2%) intervention 3: Tooth bleaching
Intervention descriptions: intervention 1: All the patient in intervention group use 10 ml of "Golnaar" mouth rinse for 2 minutes every night for 2 weeks. intervention 2: All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks. intervention 3: Tooth bleaching for both groups one time after using mouth rinses.

Protocol documents:
Clinical trial NCT02230761
Conditions: Lower Eyelid Steatoblepharon (Excess Eyelid Fat)
Keywords: steatoblepharon blepharoptosis dermatochalasis blepharoplasty periorbital orbital eyelid eyebags eye bags
Sponsor: Topokine Therapeutics, Inc.
Start date: 2014-09-01; Completion date: 2014-12-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test whether XAF5 (XOPH5) ointment, applied once daily to the lower eyelids for 10 weeks, reduces the prominence of lower eyelid fat in adults with moderate to severe steatoblepharon (excess eyelid fat).

Detailed description:

Arms: arm 1: XOPH5 Ointment is the investigational drug to be studied. arm 2: Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.
Interventions: intervention 1: XOPH5 Ointment intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02230904
Conditions: Parkinson's Disease
Keywords: Rotigotine patch Neupro Parkinson's Disease
Sponsor: UCB BIOSCIENCES GmbH
Start date: 2014-09-01; Completion date: 2014-12-01
Enrollment: 57 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of the study is to compare the adhesiveness of 2 different patch formulations of Rotigotine using the largest patch size of 40 cm\^2, under the assumption that both patch formulations show similar adhesiveness properties.

Detailed description:

Arms: arm 1: 4 day treatment (Treatment A: Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 followed by Treatment B: Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1) arm 2: 4 day treatment (Treatment B: Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 followed by Treatment A: Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1)
Interventions: intervention 1: Rotigotine (Test product PR 2.3.1) intervention 2: Rotigotine (Reference product PR 2.1.1)
Intervention descriptions: intervention 1: * Pharmaceutical form: Transdermal patch
* Concentration: 8 mg/24 hours
* Route of administration: Transdermal intervention 2: * Pharmaceutical form: Transdermal patch
* Concentration: 8 mg/24 hours
* Route of administration: Transdermal

Protocol documents:
Clinical trial NCT02232087
Conditions: Healthy
Keywords: long-acting beta agonist (LABA) corticosteroid pMDI inhaler
Sponsor: Kindeva Drug Delivery
Start date: 2014-07-01; Completion date: 2014-12-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to test the body's response to several doses of two different inhalation products in healthy volunteers.

Detailed description:
Healthy subjects will be enrolled and will receive 2, 6, and 12 inhalations from both the test and reference pMDI products according to a six-period cross-over design. Electrocardiograms (ECGs) and plasma potassium and glucose levels will be measured pre-dose and over 6 hours post-dose.

Arms: arm 1: salmeterol and fluticasone propionate, 2 puffs arm 2: salmeterol and fluticasone propionate, 2 puffs arm 3: salmeterol and fluticasone propionate, 6 puffs arm 4: salmeterol and fluticasone propionate, 6 puffs arm 5: salmeterol and fluticasone propionate, 12 puffs arm 6: salmeterol and fluticasone propionate, 12 puffs
Interventions: intervention 1: Salmeterol intervention 2: fluticasone propionate
Intervention descriptions: intervention 1: A, D 2 puffs; B, E 6 puffs; C, F 12 puffs intervention 2: A, D 2 puffs; B, E 6 puffs; C, F 12 puffs

Protocol documents:
Clinical trial NCT02245516
Conditions: Retinal Vein Occlusion Diabetic Macular Edema
Keywords: Intraretinal Fluid Subretinal Fluid Retinal Vein Occlusion Diabetic Macular Edema
Sponsor: Kala Pharmaceuticals, Inc.
Start date: 2014-07-01; Completion date: 2014-12-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of the study are to evaluate the safety and effect of KPI-121 0.25% ophthalmic suspension and KPI-121 1.0% ophthalmic suspension on intraretinal or subretinal fluid secondary to Retinal Vein Occlusion or Diabetic Macular Edema.

Detailed description:
This is a multicenter, randomized, single-masked study evaluating the safety and effect of topical ocular administration of either KPI-121 0.25% ophthalmic suspension or KPI-121 1.0% ophthalmic suspension in subjects with intraretinal or subretinal fluid secondary to Retinal Vein Occlusion or Diabetic Macular Edema.

Arms: arm 1: KPI-121 0.25% Ophthalmic Suspension dosed QID for 4 weeks in subjects with Retinal Vein Occlusion or Diabetic Macular Edema arm 2: KPI-121 1.0% Ophthalmic Suspension dosed QID for 4 weeks in subjects with Retinal Vein Occlusion or Diabetic Macular Edema
Interventions: intervention 1: KPI-121 0.25% Ophthalmic Suspension intervention 2: KPI-121 1.0% Ophthalmic Suspension
Intervention descriptions: intervention 1: KPI-121 drug product will be supplied a 0.25% loteprednol etabonate as a suspension packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate. intervention 2: KPI-121 drug product will be supplied a 1.0% loteprednol etabonate as a suspension packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.

Protocol documents:
Clinical trial NCT02263911
Conditions: Healthy Participants
Sponsor: Eli Lilly and Company
Start date: 2014-11-01; Completion date: 2014-12-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to understand the relationship of 3 different dosage forms of baricitinib. This study will also explore the effect of food on how the body absorbs baricitinib. This study will last about 5 weeks, not including screening. Screening is required within 28 days prior to the date of first dosing.

Detailed description:

Arms: arm 1: Single oral dose of 2 × 4 milligram (mg) baricitinib commercial formulation tablet fasted on Day 1 in one of five periods. arm 2: Single oral dose of 1 × 8 mg baricitinib Phase 2 tablet fasted on Day 1 in one of five periods. arm 3: Single oral dose of 1 × 4 mg baricitinib commercial formulation tablet fasted on Day 1 in one of five periods. arm 4: Single oral dose of 1 × 4 mg baricitinib Phase 2 tablet fasted on Day 1 in one of five periods. arm 5: Single oral dose of 1 × 4 mg baricitinib commercial formulation tablet after food intake on Day 1 in one of five periods.
Interventions: intervention 1: Baricitinib
Intervention descriptions: intervention 1: Administered orally

Protocol documents:
Clinical trial NCT02266472
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2014-11-01; Completion date: 2014-12-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this trial is to investigate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing empagliflozin and metformin extended release compared to the free combination of empagliflozin and metformin extended release under fed conditions.

Detailed description:

Arms: arm 1: Single dose empagliflozin/metformin arm 2: single doses empagliflozin and metformin
Interventions: intervention 1: metformin intervention 2: empagliflozin/metformin intervention 3: empagliflozin
Intervention descriptions: intervention 1: single dose of metformin given as tablets intervention 2: Single dose empagliflozin/metformin given as fixed-dose combination tablet intervention 3: single dose of empagliflozin given as tablet

Protocol documents:
Clinical trial NCT02271854
Conditions: Muscle Soreness
Sponsor: Novartis
Start date: 2014-10-01; Completion date: 2014-12-01
Enrollment: 102 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the analgesic efficacy of DSG 1% compared to placebo in the reduction of the pain associated with DOMS

Detailed description:

Arms: arm 1: diclofenac sodium gel 1% applied four times daily arm 2: Placebo gel applied four times daily
Interventions: intervention 1: Diclofenac sodium gel 1% intervention 2: Placebo
Intervention descriptions: intervention 1: Diclofenac sodium gel 1% four times daily (This study is a within-subject design i.e. active drug applied to one leg and placebo to the other leg at the same time. Therefore the study design is not a cross-over). intervention 2: Placebo gel four times daily (This study is a within-subject design i.e. active drug applied to one leg and placebo to the other leg at the same time. Therefore the study design is not a cross-over).

Protocol documents:
Clinical trial NCT02289352
Conditions: Rosacea
Sponsor: Actavis Inc.
Start date: 2014-07-01; Completion date: 2014-12-01
Enrollment: 462 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel-Design Study to Evaluate the Safety and Therapeutic Equivalence of Brimonidine Topical Gel, 0.33% (Watson Laboratories, Inc., USA) to Reference Product Mirvaso® (brimonidine) topical gel, 0.33% (Galderma Laboratories, L.P., USA) in Patients with Moderate to Severe Facial Erythema Associated with Rosacea

Detailed description:
Up to 462 patients 18 years of age and older, with confirmed clinical diagnosis of rosacea will be enrolled to have 413 in the modified intent-to-treat (mITT) population and 371 in the per-protocol (PP) population. Patients should have fewer than 3 facial inflammatory lesions, and moderate to severe erythema according to both Clinician's Erythema Assessment (CEA) and Patient's Self-Assessment (PSA).

Arms: arm 1: Brimonidine Topical Gel, 0.33%, 30 gram fill (Watson Laboratories, Inc., USA) arm 2: Mirvaso® (brimonidine) topical gel, 0.33% (Galderma Laboratories, L.P., USA) arm 3: Topical gel base only (Watson Laboratories Inc., USA)
Interventions: intervention 1: Brimonidine intervention 2: placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02295774
Conditions: Colorectal Cancer
Sponsor: Cosmo Technologies Ltd
Start date: 2013-02-01; Completion date: 2014-12-01
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Single Centre, open label assignment phase II clinical study.

To evaluate the effect of oral 200mg Methylene Blue tablets (administered 8x25mg) prior to endoscopy on double stranded DNA breaks in colonic biopsy samples assessed by histone gamma H2AX analysis, compared to control biopsies.

Detailed description:
Primary Objective: To evaluate the effect of oral 200 mg Methylene Blue MMX® tablets, (administered as 8 x 25 mg), prior to endoscopy, on double-stranded DNA breaks in colonic biopsy samples assessed by histone γH2AX analysis, compared to control biopsies collected during standard white light colonoscopy without the prior use of Methylene Blue MMX®.

Secondary Objectives : To evaluate the safety and tolerability of oral Methylene Blue MMX® tablets.. To evaluate the staining score for colonoscopy obtained with oral Methylene Blue MMX® tablets . Time to reach the caecum during colonoscopy and withdrawal time from caecum to exit.

Arms: arm 1: Biopsy samples collected during standard white light colonoscopy. arm 2: Subjects who have had samples collected during a Group A colonoscopy, who require a second colonoscopy within 2 weeks. Prior to this second colonoscopy the subjects take Methylene Blue MMX tablets. Biopsies collected are compared to their previous group A colonoscopy for histone gamma H2AX activity.
Interventions: intervention 1: standard white light colonoscopy-equivalent to placebo intervention 2: Methylene Blue MMX tablets
Intervention descriptions: intervention 1: standard white light colonoscopy intervention 2: 8x25mg methylene blue MMX tablets administered before a colonoscopy

Protocol documents:
Clinical trial NCT02324270
Conditions: Ankle Sprain
Keywords: Pain due to ankle sprain
Sponsor: Actavis Inc.
Start date: 2014-05-01; Completion date: 2014-12-01
Enrollment: 658 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To demonstrate the therapeutic efficacy of a generic diclofenac epolamine patch against Flector patch in the treatment of pain in subjects with minor ankle sprain

Detailed description:
To evaluate the therapeutic equivalence and safety of generic diclofenac epolamine 1.3% patch (Watson Laboratories, Inc.) and Flector® (diclofenac epolamine 1.3% patch) (Pfizer) in the treatment of acute pain due to minor ankle sprain.

To demonstrate the superiority of the efficacy of the test and reference products over that of the vehicle control in the treatment of acute pain due to minor ankle sprain.

To access application site reactions and patch adhesion between treatment groups.

Arms: arm 1: Flector® (Diclofenac Epolamine Topical Patch 1.3%) (Pfizer) arm 2: Generic Diclofenac Epolamine Topical Patch 1.3% (Watson Laboratories, Inc.) arm 3: Placebo patch of the test product (Watson Laboratories, Inc.); Identical in appearance and formulated as the test product, omitting the active ingredient, diclofenac epolamine
Interventions: intervention 1: Diclofenac epolamine intervention 2: Placebo
Intervention descriptions: intervention 1: Diclofenac epolamine in a topical patch formulation; applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain intervention 2: Topical patch not containing diclofenac epolamine applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain

Protocol documents: