ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00894543
Conditions: Hot Flashes Menopause Vasomotor Symptoms
Keywords: Hot flashes Menopause Vasomotor symptoms
Sponsor: Fred Hutchinson Cancer Center
Start date: 2009-07-01; Completion date: 2010-06-01
Enrollment: 205 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test whether a medication reduces the number, severity and bothersomeness of menopausal hot flashes. Escitalopram (also called Lexapro®) is a selective serotonin reuptake inhibitor (SSRI). It is sold by prescription for depression and general anxiety disorder. An SSRI increases serotonin, a brain substance that is believed to influence mood. Serotonin may also affect brain levels of estradiol, a hormone related to hot flashes. This research study will test whether escitalopram reduces menopausal hot flashes.

Detailed description:
The MsFLASH-01 study, Efficacy of a Selective Serotonin Reuptake Inhibitor (SSRI) for Menopausal Symptoms in Midlife Women is a randomized, double-blind, placebo-controlled, parallel arm clinical trial. The design includes: 3 weeks of daily recording of hot flashes prior to drug treatment; 8 weeks of double-blind treatment with escitalopram or placebo with dose escalation at 4 weeks among non-responders; 1 week of drug taper for those on higher dose, followed by 2 weeks with no treatment; and a telephone follow-up post-treatment. This study is one of five clinical trials to be conducted as part of the Menopause Strategies - Finding Lasting Answers for Symptoms and Health (MsFLASH) study, a network of investigators and clinical trials designed to find new ways to alleviate the most common, bothersome symptoms of the menopausal transition.

Arms: arm 1: Escitalopram is a selective serotonin reuptake inhibitor (SSRI) arm 2: Inactive pill
Interventions: intervention 1: Escitalopram intervention 2: Placebo
Intervention descriptions: intervention 1: 10 mg (1 pill) escitalopram daily for the first four weeks. Dose increased to 20 mg (2 pills) escitalopram daily if relief from hot flashes has not occurred during the first four weeks of the daily 10 mg dose. intervention 2: Inactive pill (1 pill or 2 pills) daily for the 8-11 weeks of the trial.

Protocol documents:
Clinical trial NCT00907738
Conditions: Advanced Cancer
Sponsor: Merck Sharp & Dohme LLC
Start date: 2005-08-01; Completion date: 2010-06-01
Enrollment: 27 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the safety and tolerability of continuing vorinostat (MK-0683) dosing in cancer patients previously enrolled in one of five base studies (MK-0683-001, MK-0683-006, MK-0683-008, MK-0683-012, or MK-0683-013) who have shown benefit from receiving this drug.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: vorinostat
Intervention descriptions: intervention 1: All patients will receive vorinostat at the same dose and schedule as they received in the base protocol until disease progression or unacceptable toxicity.

Protocol documents:
Clinical trial NCT00909480
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2009-05-01; Completion date: 2010-06-01
Enrollment: 457 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia, South America and the United States of America (USA).

The aim of this clinical trial is to determine whether two insulin treatments given once daily are equally effective with respect to the blood glucose lowering effect in subjects with type 2 diabetes inadequately controlled on metformin treatment with or without an additional anti-diabetic drug (OAD).

Detailed description:

Arms: arm 1: Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day arm 2: Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
Interventions: intervention 1: insulin detemir intervention 2: insulin glargine
Intervention descriptions: intervention 1: Treat-to-target (individually adjusted dose) titration according to titration algorithm.

S.c. (under the skin) injection once daily as an add-on to subjects' stable pre-trial metformin dose (at least 1500 mg/day). Any other use of OAD will be discontinued intervention 2: Treat-to-target (individually adjusted dose) titration according to titration algorithm.

S.c. (under the skin) injection once daily as an add-on to subjects' stable pre-trial metformin dose (at least 1500 mg/day). Any other use of OAD will be discontinued

Protocol documents:
Clinical trial NCT00910208
Conditions: Pain
Keywords: Pain Analgesia Analgesia, Patient-controlled Emergency Medicine
Sponsor: Albert Einstein College of Medicine
Start date: 2009-04-01; Completion date: 2010-06-01
Enrollment: 211 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aims of this study are to assess efficacy and safety of patient-controlled analgesia (PCA) when applied to the Emergency Department setting and to compare the efficacy and safety of two PCA dosing regimens.

Detailed description:
The safety, efficacy, and dosing of PCA will be assessed in a randomized trial with three treatment arms:

1. PCA with 1.0 mg morphine demand dosing every 6 minutes,
2. PCA with 1.5 mg demand dosing every 6 minutes and
3. a non-PCA comparison group.

All patients will receive a loading dose of 0.1 mg/kg morphine. All patients can receive additional analgesics as needed, at the discretion of the provider.

We hypothesize that morphine supplied via PCA will provide superior analgesia without a greater incidence of adverse events when compared to non-PCA pain management; and that PCA demand dosing of 1.5 mg will be superior to 1.0 mg without more adverse events.

Arms: arm 1: 0.1 mg/kg morphine loading dose plus PCA with 1.0 mg morphine demand dosing every 6 minutes arm 2: 0.1 mg/kg morphine loading dose plus PCA with 1.5 mg morphine demand dosing every 6 minutes arm 3: 0.1 mg/kg morphine loading dose plus additional analgesia as needed
Interventions: intervention 1: Patient-controlled analgesia intervention 2: morphine
Intervention descriptions: intervention 1: Intravenous morphine delivered via Curlin painsmart PCA device intervention 2: Intravenous morphine

Protocol documents:
Clinical trial NCT00927472
Conditions: Pediculosis
Keywords: Head Lice
Sponsor: Sun Pharmaceutical Industries, Inc.
Start date: 2009-08-01; Completion date: 2010-06-01
Enrollment: 254 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this study, Malathion Gel 0.5% will be compared to Nix (permethrin 1%) as a treatment for head lice in patients 2 years of age and older. Malathion Gel 0.5% is a new formulation of an established head lice treatment. The new formulation has been evaluated in 2 previous studies of patients 2 years of age and older.

Detailed description:
This is a Phase III, multi-center, investigator-blinded, two-arm, randomized, parallel group study, evaluating the safety and efficacy of a Malathion Gel, 0.5% formulation, manufactured by Taro. The objective is to show superiority of the novel product to an active control, Nix® Crème Rinse, manufactured by Insight Pharmaceuticals.

Arms: arm 1: Malathion gel 0.5% 30 minute application arm 2: Nix applied to scalp for 10 minutes
Interventions: intervention 1: Malathion gel 0.5% intervention 2: Permethrin 1% rinse
Intervention descriptions: intervention 1: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present. intervention 2: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present.

Protocol documents:
Clinical trial NCT00928889
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes mellitus, type 2 nateglinide acarbose hyperglycemia dyslipidemias C-reactive protein
Sponsor: Novartis Pharmaceuticals
Start date: 2009-07-01; Completion date: 2010-06-01
Enrollment: 160 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was conducted to demonstrate superiority of nateglinide in postprandial glucose fluctuation, dyslipidemia, and inflammatory status improvement.

Detailed description:

Arms: arm 1: Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks. arm 2: Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
Interventions: intervention 1: Nateglinide 120 mg intervention 2: Acarbose 50 mg
Intervention descriptions: intervention 1: Nateglinide 120 mg was supplied as tablets. intervention 2: Acarbose 50 mg was supplied as tablets.

Protocol documents:
Clinical trial NCT00934089
Conditions: Glaucoma, Open-Angle Ocular Hypertension
Sponsor: Pfizer
Start date: 2010-01-01; Completion date: 2010-06-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will characterize the effect of PF-04217329, alone and in combination with latanoprost, on circadian intraocular pressure and blood pressure in glaucoma patients. Blood samples will be collected to measure the amount of active metabolite of PF-04217329 in the plasma following dosing.

Detailed description:

Arms: arm 1: Active study drug + latanoprost vehicle arm 2: Active study drug + latanoprost
Interventions: intervention 1: PF-04217329 intervention 2: latanoprost vehicle intervention 3: PF-04217329 intervention 4: latanoprost
Intervention descriptions: intervention 1: Topical ocular solution, once-daily for 14 days intervention 2: Topical ocular solution, once-daily for 14 days intervention 3: Topical ocular solution, once-daily for 14 days intervention 4: Topical ocular solution, once-daily for 14 days

Protocol documents:
Clinical trial NCT00979953
Conditions: Osteoarthritis of the Knee
Keywords: delta opioid receptor agonist osteoarthritis pain
Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2009-10-01; Completion date: 2010-06-01
Enrollment: 408 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy of ADL5859 versus placebo and ADL5747 versus placebo in relieving pain in participants with osteoarthritis of the knee.

Detailed description:

Arms: arm 1: One 50-milligrams (mg) ADL5859 capsule, one 100-mg ADL5859 capsule, and 2 placebo capsules administered orally twice daily (BID) for 14 days arm 2: One 150-mg ADL5747 capsule and 3 placebo capsules administered orally BID for 14 days arm 3: One 10-mg Oxycodone controlled release (CR) capsule and 3 placebo capsules administered orally BID Days 1 through 4

One 20-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 5 through 14 arm 4: Four placebo capsules administered orally BID for 14 days
Interventions: intervention 1: ADL5859 intervention 2: ADL5747 intervention 3: Oxycodone CR intervention 4: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00983918
Conditions: Postoperative Pain
Sponsor: Baylor College of Medicine
Start date: 2009-09-01; Completion date: 2010-06-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To the investigators' knowledge, no study has looked at differences in postoperative pain when comparing maintenance of anesthesia with isoflurane, desflurane, sevoflurane, and propofol in laparoscopic cholecystectomy. The investigators' hypothesis is that total intravenous anesthesia with propofol will lead to less postoperative pain in the first 24 hours after laparoscopic cholecystectomy when compared to maintenance of anesthesia with isoflurane, desflurane or sevoflurane.

PURPOSE

To find out if maintenance of anesthesia with propofol leads to less postoperative pain after laparoscopic cholecystectomy when compared to maintenance of anesthesia with isoflurane, desflurane, or sevoflurane.

Detailed description:

Arms: arm 1: General Anesthesia with Desflurane arm 2: General Anesthesia with Sevoflurane arm 3: General Anesthesia with Isoflurane arm 4: General Anesthesia with Propofol
Interventions: intervention 1: Desflurane intervention 2: Sevoflurane intervention 3: Isoflurane intervention 4: Propofol
Intervention descriptions: intervention 1: Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Desflurane intervention 2: Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Sevoflurane intervention 3: Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Isoflurane intervention 4: Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with intravenous Propofol infusion

Protocol documents:
Clinical trial NCT00985959
Conditions: Multiple Myeloma
Keywords: Multiple myeloma Hematopoietic stem cell transplant HSCT Melphalan Prednisolone Bortezomib JNJ-26866138
Sponsor: Janssen Pharmaceutical K.K.
Start date: 2008-07-01; Completion date: 2010-06-01
Enrollment: 101 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study in Phase I is to select the recommended dose of bortezomib in combination with melphalan and prednisolone in Japanese participants. In Phase II, to assess the effectiveness and safety of the recommended dose of bortezomib (selected in the phase I portion).

Detailed description:
This is an open-label (both physician and participant know the intervention), non-randomized (participants are not assigned by chance), multi-center study in untreated multiple myeloma participants who were not candidates for hematopoietic stem cell transplant. This study consists of two parts: Phase I and Phase II. In Phase I, a total of 18 participants will be enrolled ie, 6 patients per dose level (0.7, 1.0 and 1.3 mg/m2) to determine the recommended dose of bortezomib. In Phase II, additional 83 participants will be enrolled. Safety evaluations will include assessment of adverse events, clinical laboratory test, specifically hematological toxicities.

Arms: arm 1: JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles. arm 2: JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles arm 3: JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles arm 4: JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
Interventions: intervention 1: JNJ-26866138 0.7 mg/m2 intervention 2: JNJ-26866138 1.0 mg/m2 intervention 3: JNJ-26866138 1.3 mg/m2 intervention 4: Melphalan intervention 5: Prednisolone
Intervention descriptions: intervention 1: JNJ-26866138 0.7 mg/m2 will be administered intravenously on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. intervention 2: JNJ-26866138 1.0 mg/m2 will be administered intravenously on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles intervention 3: Phase I: JNJ-26866138 1.3 mg/m2 will be administered intravenously on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Phase II: JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5 to 9 cycles. intervention 4: Melphalan 9 mg/m2 will be taken orally (by mouth) on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles intervention 5: Prednisolone 60 mg/m2 will be taken orally (by mouth) on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles

Protocol documents:
Clinical trial NCT00990561
Conditions: Stable Plaque Psoriasis
Sponsor: University of California, San Francisco
Start date: 2009-07-01; Completion date: 2010-06-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an investigator-masked, randomized, parallel, clinical study comparing the efficacy of once daily versus twice daily application of Ultravate® ointment (halobetasol propionate 0.05% ointment) in combination with Lac-Hydrin lotion (ammonium lactate topical) in the treatment of stable plaque psoriasis. 1) Phase 1: Patients will be treated for two weeks with combination therapy using Ultravate® ointment with Lac-Hydrin lotion and their psoriasis plaques will be evaluated to test efficacy of the medication. Half the subjects will be randomized to receive treatment with once a day Ultravate® ointment and twice daily Lac-Hydrin lotion; the other half of subjects will receive twice daily Ultravate® ointment with twice daily Lac-Hydrin lotion. Ultravate® ointment will be discontinued following two weeks of treatment, in compliance with its FDA indication. Phase 2: The second treatment phase will consist of a four-week observation period. Subjects will be re-randomized to either continue using twice daily Lac-Hydrin lotion, versus no treatment. The purpose of this second phase of the study is to investigate whether use of Lac-Hydrin monotherapy twice daily can minimize risk of recurrence and maximize duration of therapeutic effect. Part of this clinical study consists of the use of patient and physician satisfaction questionnaires. These questionnaires will include questions about the satisfaction with the formulation of each agent, questions about compliance with treatment, etc. Such questions could be used to demonstrate patient and physician satisfaction with each agent, with combination therapy, and to compare patient satisfaction rates among those randomized to once daily versus twice daily application of Ultravate® ointment. The hypothesis is that Ultravate ointment once daily in combination with Lac-Hydrin twice daily is equal in efficacy to Ultravate ointment twice daily in combination with Lac-Hydrin twice daily.

Detailed description:

Arms: arm 1: Patients will apply both Ultravate ointment and LacHydrin lotion twice daily arm 2: Patients will apply Ultravate ointment once daily, but will use LacHydrin lotion twice daily
Interventions: intervention 1: Ultravate ointment twice daily + LacHydrin lotion twice daily intervention 2: Ultravate ointment once daily + LacHydrin lotion twice daily
Intervention descriptions: intervention 1: Topical corticosteroid intervention 2: Topical corticosteroid

Protocol documents:
Clinical trial NCT00993421
Conditions: Obesity
Sponsor: Eli Lilly and Company
Start date: 2009-10-01; Completion date: 2010-06-01
Enrollment: 343 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if LY377604 + sibutramine work better than LY377604 or sibutramine alone in the treatment of obesity.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None
Interventions: intervention 1: LY377604 intervention 2: Sibutramine intervention 3: Metoprolol intervention 4: Placebo sibutramine intervention 5: Placebo Metoprolol intervention 6: Placebo LY377604
Intervention descriptions: intervention 1: Given daily, orally for 24 weeks intervention 2: given daily, orally for 24 weeks intervention 3: given daily, orally for 24 weeks (100 mg for 1 week followed by 200 mg for 23 weeks. Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper (1 week at 100 mg/day followed by 1 week at 50 mg/day). intervention 4: given daily, orally for 24 weeks intervention 5: given daily, orally for 26 weeks (24 weeks plus 2 weeks of taper) intervention 6: given daily, orally for 24 weeks

Protocol documents:
Clinical trial NCT00998881
Conditions: Type 2 Diabetes Mellitus
Keywords: insulin resistance
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2009-09-01; Completion date: 2010-06-01
Enrollment: 203 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of MP-513 (Teneligliptin) in patients with type 2 Diabetes for 12 weeks administration.

Detailed description:

Arms: arm 1: Teneligliptin 20 mg, orally, once daily arm 2: Teneligliptin placebo-matching tablets, orally, once daily
Interventions: intervention 1: Teneligliptin 20 mg intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01001767
Conditions: HIV Infections Heart Disease
Keywords: Omega-3 Fatty Acids HIV Heart Disease Treatment experienced
Sponsor: University Hospitals Cleveland Medical Center
Start date: 2009-04-01; Completion date: 2010-06-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Several studies have shown that there is an increased risk of heart disease in people with HIV. In this study the investigators are looking at the effect of Lovaza (Omega-3 fatty acid) on improving endothelial function and decreasing inflammation which may contribute to this increased risk. The investigators will also be doing studies to analyze coagulation and inflammation markers.

Detailed description:

Arms: arm 1: Lovaza 1 gram by mouth twice a day for 24 weeks. arm 2: Placebo capsule by mouth twice a day x 24 weeks.
Interventions: intervention 1: Lovaza intervention 2: Placebo
Intervention descriptions: intervention 1: Lovaza one gram twice a day for 24 weeks intervention 2: Placebo

Protocol documents:
Clinical trial NCT01004354
Conditions: Obesity Vitamin D Deficiency Psychosis Schizophrenia Schizoaffective Disorder
Keywords: Psychiatric illnesses Vitamin D deficiency Obesity
Sponsor: University of Massachusetts, Worcester
Start date: 2009-06-01; Completion date: 2010-06-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Children and adolescents with psychiatric illnesses who are treated with medications called second generation antipsychotic agents (SGA) often gain excessive weight during their treatment with these medications. This weight gain may result in the development of features of the metabolic syndrome or frank diabetes mellitus. There is no consensus on the best way to prevent these complications. The investigators' hypothesis is that daily vitamin D supplementation in these patients will result in decreased levels of the markers of metabolic syndrome with associated reduction in waist circumference.

Detailed description:
In this 8-week open label trial, we will enroll 10 subjects who fulfill the Inclusion Criteria.

Arms: arm 1: None
Interventions: intervention 1: Ergocalciferols
Intervention descriptions: intervention 1: 2000 international units by mouth daily for 8 weeks.

Protocol documents: