ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00714233
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic Ovary Syndrome Overweight Adolescent Girls Irregular Menstrual Cycles
Sponsor: University of Rochester
Start date: 2002-08-01; Completion date: 2007-12-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A 24 week study to compare the use of Metformin, birth control pills and a carefully planned intensive lifestyle program that includes weight loss and exercise. These approaches will be compared to placebo (a pill that contains no active substances. Metformin, birth control pills and the lifestyle management program will be used on this research study to compare their ability to:

1. reduce fasting glucose levels
2. reduce androgen hormone levels
3. improve sex steroid binding, and
4. improve lipids (fatty substances in the blood)

Detailed description:
Polycystic ovary syndrome (PCOS) is a condition associated with irregular menstrual cycles, (due to lack of regular ovulation), and evidence of elevated androgen (male hormone) levels, such as unwanted hair growth or acne. This condition often becomes recognized at the time of puberty. The standard treatment for this condition is oral contraceptive pills, which are used not for contraception, but to cause a regular, monthly bleeding pattern.

Many adolescents with PCOS have increased levels of insulin, a hormone that controls the body's sugar balance. These increased insulin levels may play a role in the development of polycystic ovary syndrome. There are several medications now available, which can decrease the insulin levels by improving the action of insulin in the body. Metformin is one of these drugs. Metformin is a drug currently used in the management of diabetes to control blood sugar. It is hoped that by lowering the insulin levels some of the symptoms of polycystic ovary syndrome, such as the lack of regular periods and unwanted hair growth, can be reversed or diminished.

Arms: arm 1: Metformin arm 2: Oral Contraceptive Pills arm 3: lifestyle modification program arm 4: placebo to active metformin arm
Interventions: intervention 1: Metformin intervention 2: Oral Contraceptive Pills (Yasmin) intervention 3: Lifestyle Modification intervention 4: placebo
Intervention descriptions: intervention 1: Metformin 425mg. capsules, 2 capsules BID x 24 weeks intervention 2: Yasmin oral contraceptive tabs; 1 tab daily x 24 weeks intervention 3: weekly classes x 24 weeks for training in diet, exercise and behavior modification skills intervention 4: placebo to the active metformin arm. 2 capsules BID x 24 weeks.

Protocol documents:
Clinical trial NCT00926328
Conditions: Gingivitis
Keywords: Gingivitis and Plaque
Sponsor: Colgate Palmolive
Start date: 2007-06-01; Completion date: 2007-12-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the performance of two toothpastes in controlling established gingivitis and dental plaque in adults.

Detailed description:

Arms: arm 1: triclosan/copolymer/fluoride toothpaste arm 2: sodium fluoride only toothpaste (placebo)
Interventions: intervention 1: Triclosan, fluoride intervention 2: Fluoride
Intervention descriptions: intervention 1: Six Month study, brush twice daily intervention 2: twice daily usage

Protocol documents:
Clinical trial NCT00959907
Conditions: Wrinkles in Frontal Area
Keywords: Muscular activity wrinkles in frontal area action halos
Sponsor: Brazilan Center for Studies in Dermatology
Start date: 2005-05-01; Completion date: 2007-12-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to compare the action halos of the botulinum toxins (Dysport® and Botox®) using two equivalence-ratios and to gather supportive information, such as more detailed data on the effectiveness in reduction of wrinkles and duration of action on the upper part of the face of both products, trough scales and photographs evaluations.

Detailed description:
This was a monocentric, prospective, randomized and double-blind study. Fifty nine female patients, presenting with moderate to severe forehead wrinkles, with sweating ability who had never undergone previous BoNT-A injections were enrolled. There were two randomizations, one related to the dose-equivalence (2:1U and 2.5:1U), both reconstituted in the same volume of 0.02 mL per point and another related to the forehead side (left or right) for application of the tested drugs. Baseline, twenty-eight and 112 days later, clinical and photographic assessments, Minor´s test, and electromyographic (EMG) evaluations were performed.

Arms: arm 1: BoNT A1 (4U): Botulinum toxin A (Dysport®)4 units arm 2: BoNT-A2(2U): Botulinum toxin A (Botox®) 2 units
Interventions: intervention 1: BOTULINUM TOXIN TYPE-A
Intervention descriptions: intervention 1: On Visit 1 (Day 0):

Botulinum toxin A (Dysport® and Botox®) will be administered according to an equivalence ratio of 2:1. Both reconstituted in the same volume per point, injected in the forehead determined site.

* Dysport®: 4 units will be injected in the left or right forehead side.
* Botox® : 2 units will be injected in the left or right forehead side.(opposite side of dysport injection)

Protocol documents:
Clinical trial NCT00981825
Conditions: Salivary Bacteria Levels
Sponsor: Colgate Palmolive
Start date: 2007-10-01; Completion date: 2007-12-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Research study to compare the effects of brushing with two commercially available toothpastes on salivary bacteria after brushing

Detailed description:

Arms: arm 1: fluoride toothpaste control arm 2: triclosan/fluoride toothpaste
Interventions: intervention 1: Fluoride intervention 2: Triclosan/Fluoride
Intervention descriptions: intervention 1: Whole mouth brushing for 7 days intervention 2: Brush whole mouth twice daily for 7 days

Protocol documents:
Clinical trial NCT00989768
Conditions: Wrinkles in Frontal Area
Keywords: Botulinum toxin type A field effects dose-equivalence anhydrotic action halos
Sponsor: Brazilan Center for Studies in Dermatology
Start date: 2005-05-01; Completion date: 2007-12-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to compare the field of effects of the botulinum toxins (Dysport® and Botox®) using two equivalence-ratios and to gather supportive information, such as more detailed data on the effectiveness in reduction of wrinkles and duration of action on the upper part of the face of both products, trough scales and photographs evaluations.

Detailed description:
This was a monocentric, prospective, randomized and double-blind study. Twenty nine female patients, presenting with moderate to severe forehead wrinkles, with sweating ability who had never undergone previous BoNT-A injections were enrolled. Subjects have received botulinum toxin type-A injections in two forehead sites, Botox 2U and Dysport 5U, both reconstituted in the same volume of 0.02 mL per point. Baseline, twenty-eight and 112 days later, clinical and photographic assessments, Minor´s test, and electromyographic (EMG) evaluations were performed.

Arms: arm 1: Dysport® compared to Botox®
Interventions: intervention 1: Botulinum Toxin Type A (Dysport®) intervention 2: Botulinum Toxin Type A/Botox® intervention 3: Botulinum Toxin Type A/Dysport®
Intervention descriptions: intervention 1: Botulinum toxin A (Dysport®)will be administered according to an equivalence ratio of 2,5:1. Both reconstituted in the same volume per point, injected in the forehead determined site.

-Dysport®: 5 units will be injected in the left or right forehead side. intervention 2: 2 units will be injected in the left or right forehead side.(opposite side of dysport injection) intervention 3: Botulinum toxin A (Dysport®)will be administered according to an equivalence ratio of 2:1. Both reconstituted in the same volume per point, injected in the forehead determined site.

-Dysport®: 4 units will be injected in the left or right forehead side, 2:1 ratio Dysport/Botox.

Protocol documents:
Clinical trial NCT01021020
Conditions: Healthy
Keywords: bioequivalence fasting fed healthy
Sponsor: Mutual Pharmaceutical Company, Inc.
Start date: 2007-09-01; Completion date: 2007-12-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This randomized, single dose, three-way crossover study will evaluate the bioequivalence of two formulations of colchicine, the test product (colchicine 0.6mg Mutual) and a marketed combination product (colchicine 0.5 mg with probenecid 500 mg), administered under fasting conditions. It will also determine the bioavailability following a standard high-fat meal and evaluate the safety and tolerability of the test product.

Detailed description:
This randomized, single dose, three-way crossover study will evaluate the bioequivalence of two formulations of colchicine, the test product (colchicine 0.6mg Mutual) and a marketed combination product (colchicine 0.5mg with probenecid 500mg), administered under fasting conditions. It will also determine the bioavailability of the test product following a standard high-fat meal and evaluate the safety and tolerability of the test product. Twenty-eight healthy, non-smoking, non-obese (BMI 81-30 kg/m2 and BW ≥110 lbs), 18-45 year old, male and female volunteers will be randomly assigned in a crossover fashion to receive one of three dosing regimens in sequence with washout periods of at least 14 days between dosing periods. After a fast of at least 10 hours, subjects will receive either, one tablet of colchicine 0.6 mg, one tablet of colchicine 0.6 mg after a standardized high-fat,high-calorie breakfast or 0.5mg/500mg colchicine/probenecid. All doses will be given with 240mL of room temperature water. Patients will be confined for at least 15 hours before and 24 hours after each dose with daily outpatient visits over the following 3 days. Blood will be drawn at times sufficient to adequately define the concentration time curves for each dosing regimen, which will be compared to assess the bioequivalence of the reference and test products and the effect of food on the test product. Subjects will also be monitored for adverse events throughout this same period.

Arms: arm 1: Colchicine (fasted) arm 2: Colchicine (fed) arm 3: Colchicine/Probenecid (fasted)
Interventions: intervention 1: Colchicine intervention 2: Colchicine intervention 3: Colchicine/Probenecid
Intervention descriptions: intervention 1: 0.6mg tablet administered after a fast of at least 10 hours intervention 2: 0.6mg tablet administered after a standardized high-fat, high-calorie breakfast intervention 3: 0.5mg/500mg tablet administered after a fast of at least 10 hours

Protocol documents:
Clinical trial NCT01072201
Conditions: Mucositis
Sponsor: Colgate Palmolive
Start date: 2007-06-01; Completion date: 2007-12-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Clinical research for the treatment of mucositis subjects who have dental implants for a minimum of one-year.

Detailed description:

Arms: arm 1: Triclosan/copolymer/fluoride toothpaste arm 2: Fluoride Toothpaste
Interventions: intervention 1: Triclosan and Fluoride intervention 2: Fluoride
Intervention descriptions: intervention 1: Brush twice daily intervention 2: Brush twice daily

Protocol documents:
Clinical trial NCT01178762
Conditions: Chlamydial Conjunctivitis
Keywords: Oral Azithromycin Chlamydial Conjunctivitis
Sponsor: National Taiwan University Hospital
Start date: 2007-09-01; Completion date: 2007-12-01
Enrollment: 42 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Chlamydia trachomatis is one of the major causes of sexually transmitted disease and also the leading infectious cause of blindness in the world.Treatment of C. trachomatis eye infection has involved for a long time. The efficacy of single dose azithromycin has already been demonstrated as effective in the treatment of both trachoma and adult inclusion conjunctivitis.However, in our clinical experience, some patients of chlamydial conjunctivitis may require augmented single dose azithromycin treatments before C. trachomatis is eradicated. In this way, we would like to known the efficacy of single dose and augmented single dose azithromycin in the treatment of chlamydial conjunctivitis.

Detailed description:
Medical records of patients with clinically suspected chlamydial conjunctivitis between January 1, 2006 and December 31, 2006 at one cornea specialist's (Y.C.H) out-patient clinic were retrospectively reviewed. At this clinic, patients of both sexes with acute, chronic or recurrent follicular conjunctivitis with the symptoms and signs of chlamydial conjunctivitis suspected were tested for Chlamydia direct fluorescent antibody (DFA) tests and arranged for next time out-patient clinic follow up 1-2 weeks later. The patients who attended the follow up visit with positive DFA results were treated with oral azithromycin. These patients received a single dose oral azithromycin (400mg\~1000mg, according to their age and body weight) once a week for consecutive two weeks. Repeated DFA examinations were performed 4 to 6 weeks later. If the DFA examinations still showed positive results, augmented single dose oral azithromycin once a week for one week was given again till the DFA showed negative results. The occurrence and frequency of adverse events recorded in the medical charts were reviewed as well.

Arms: arm 1: None
Interventions: intervention 1: Azithromycin
Intervention descriptions: intervention 1: Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis

Protocol documents:
Clinical trial NCT01263470
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus - Type 2 Diabetes Mellitus Drug Therapy
Sponsor: Takeda
Start date: 2007-01-01; Completion date: 2007-12-01
Enrollment: 480 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the dose-response relationships of alogliptin, once daily (QD) to an α-glucosidase inhibitor, three times daily (TID), to determine the optimal clinical dose for type 2 diabetic patients.

Detailed description:
Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.

Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes.

To evaluate the long-term safety and efficacy of alogliptin, participants in the present study could enter a long-term extension study SYR-322/OCT-001 (NCT01263496) that was planned separately.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: Alogliptin intervention 2: Alogliptin intervention 3: Alogliptin intervention 4: Alogliptin intervention 5: Voglibose intervention 6: Placebo
Intervention descriptions: intervention 1: Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks intervention 2: Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. intervention 3: Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. intervention 4: Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks intervention 5: Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks. intervention 6: Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.

Protocol documents:
Clinical trial NCT00399802
Conditions: Breast Cancer Metastatic Bone Disease
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-11-16; Completion date: 2007-12-05
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 4-week study to examine the effects of a new experimental medication on women with breast cancer and established bone metastases. This study will enroll approximately 45 women. The primary hypotheses are: (1) odanacatib will result in a substantial suppression of urinary N-telopeptide of type I collagen (u-NTx) similar to that achieved with an intravenous (IV) infusion of zoledronic acid (ZA) over 4 weeks of treatment; and (2) odanacatib (MK-0822) will be safe and well tolerated during 4 weeks of treatment.

Detailed description:

Arms: arm 1: Participants will receive a single IV infusion of ZA 4 mg at the start of treatment and a once-daily odanacatib matching placebo tablet for 4 weeks. arm 2: Participants will receive a once-daily odanacatib 5 mg tablet for 4 weeks and a single IV infusion of ZA matching placebo at the start of treatment.
Interventions: intervention 1: ZA intervention 2: Odanacatib intervention 3: Odanacatib matching placebo intervention 4: ZA matching placebo
Intervention descriptions: intervention 1: Single ZA 4 mg IV infusion at the start of treatment intervention 2: Once-daily odanacatib 5 mg tablet for 4 weeks intervention 3: Once-daily odanacatib matching placebo for 4 weeks intervention 4: Single IV infusion of ZA matching placebo given at the start of treatment

Protocol documents:
Clinical trial NCT00500149
Conditions: ADHD
Sponsor: Shire
Start date: 2007-06-13; Completion date: 2007-12-05
Enrollment: 129 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this study is to assess the time of onset of Vyvanse compared to placebo, in the analog classroom as measured by the Swanson, Kotkin, Agler, M. Flynn and Pelham (SKAMP) deportment scale in children (aged 6-12) diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Vyvanse (lisdexamfetamine dimesylate) intervention 2: Placebo
Intervention descriptions: intervention 1: Following completion of the open-label dose optimization period and successful titration to an optimal dose of Vyvanse™, subjects will take their optimized dose of Vyvanse™ (30, 50 or 70 mg/day). intervention 2: Placebo

Protocol documents:
Clinical trial NCT00368979
Conditions: Prostatic Hyperplasia
Keywords: Benign Prostatic Hyperplasia BPH dutasteride
Sponsor: GlaxoSmithKline
Start date: 2006-02-17; Completion date: 2007-12-06
Enrollment: 378 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the efficacy and safety of GI198745 0.5mg given once daily for 52 weeks to Benign Prostatic Hyperplasia (BPH) patients.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Dutasteride intervention 2: Placebo
Intervention descriptions: intervention 1: once daily intervention 2: once daily

Protocol documents:
Clinical trial NCT00213148
Conditions: Anovulation
Sponsor: EMD Serono
Start date: 2005-03-10; Completion date: 2007-12-12
Enrollment: 271 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate and compare the safety and efficacy of various doses of the aromatase inhibitor (anastrozole) versus clomiphene citrate in stimulating follicular growth and ovulation in infertile women with ovulatory dysfunction.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Anastrozole 1 mg intervention 2: Anastrozole 5 mg intervention 3: Anastrozole 10 mg intervention 4: Clomiphene Citrate 50 mg intervention 5: Clomiphene Citrate 100 mg
Intervention descriptions: intervention 1: Subjects will be administered orally with 1 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). intervention 2: Subjects will be administered orally with 5 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). intervention 3: Subjects will be administered orally with 10 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). intervention 4: Subjects will be administered orally with 50 mg of clomiphene citrate once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). intervention 5: Subjects will be administered orally with 100 mg of clomiphene citrate once daily for 5 days in Cycle 2 and 3 (each cycle = approximately 1 month).

Protocol documents:
Clinical trial NCT00091572
Conditions: Melanoma
Keywords: Metastatic Melanoma
Sponsor: Merck Sharp & Dohme LLC
Start date: 2004-10-20; Completion date: 2007-12-31
Enrollment: 859 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to ascertain if the extended schedule of Temozolomide, which allows increased doses and potential depletion of the enzyme underlaying resistance, is a more effective treatment of metastatic melanoma than single agent dacarbazine.

Detailed description:

Arms: arm 1: temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously) arm 2: dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
Interventions: intervention 1: Temozolomide intervention 2: Dacarbazine
Intervention descriptions: intervention 1: oral capsule; 150 mg/m2/day PO (by mouth), on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously); one cycle of temozolomide is defined as a 6-week period; treatment will continue until progression of the disease, unacceptable toxicity, subject refusal, or opinion of the treating physician that it is in the subject's best interest to stop. intervention 2: intravenous solution; dacarbazine 1000 mg/m2 IV (in the vein), on Day 1 +/- 3 days every 3 weeks; one cycle of dacarbazine is defined as a 3-week period; treatment will continue until progression of the disease, unacceptable toxicity, subject refusal, or opinion of the treating physician that it is in the subject's best interest to stop.

Protocol documents:
Clinical trial NCT00207142
Conditions: HIV Infections
Keywords: Treatment Naive HIV-1 infected treatment naive patients
Sponsor: Bristol-Myers Squibb
Start date: 2005-11-01; Completion date: 2008-01-01
Enrollment: 252 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the proportion of subjects with HIV-1 RNA viral load \< 50 c/mL through Week 48 of the Maintenance Phase among HIV-infected subjects with an initial undetectable viral load following an Induction Phase with an ATV/RTV containing HAART regimen, when switched to ATV versus remaining on ATV/RTV, whilst continuing their previous NRTI backbone.

Detailed description:

Arms: arm 1: ATV 400 mg + 2 NRTIs (TBD), ATV once daily, NRTIs (TBD) arm 2: ATV 300 mg + RTV 100 mg + 2 NRTIs (TBD), ATV and RTV once daily, NRTIs (TBD) arm 3: ATV 300 mg + RTV 100 mg + 2 NRTIs (TBD), ATV and RTV once daily, NRTIs (TBD)
Interventions: intervention 1: Atazanavir + 2 NRTIs intervention 2: Atazanavir + Ritonavir + 2 NRTIs
Intervention descriptions: intervention 1: Capsules, tablets, Oral, 48 weeks (after a 26-to-30-week induction phase with ATV 300 mg + RTV 100 mg + 2 NRTIs) intervention 2: Capsules, tablets, Oral, 48 weeks (after a 26-to-30-week induction phase with ATV 300 mg + RTV 100 mg + 2 NRTIs)

Protocol documents: