ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00381043
Conditions: Alcohol Dependence
Keywords: Alcohol Dependence Family Medicine Setting University of North Carolina at Chapel Hill
Sponsor: University of North Carolina, Chapel Hill
Start date: 2006-08-01; Completion date: 2008-07-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a study of a medication, acamprosate, which is an FDA approved medication for alcohol problems. We will be examining whether acamprosate compared to a sugar pill (placebo) is more effective for helping with drinking in a Family Medicine clinic.

Detailed description:
Acamprosate has been shown to reduce drinking days in alcohol dependent patients and promote abstinence, with few reported side effects. A limitation of these studies, however, has been their lack of generalizability due to restrictive inclusion and exclusion criteria. Furthermore, most of the previous studies of acamprosate have been conducted in Europe, in a different treatment setting from the typical American Family Medicine center, where alcohol dependent patients are most likely to be first identified in the U.S.

The present study is designed to determine the efficacy of acamprosatefor alcohol dependence in a Family Medicine setting using minimal psychotherapeutic interventions-as would also likely occur in a primary care setting. The study will be a 12-week, double-blind, placebo-controlled, randomized trial comparing 666 mg acamprosate t.i.d. to placebo in patients at the UNC Family Medicine Center with alcohol dependence. Subjects will be seen by Family Medicine physicians and receive brief motivational interventions. Primary efficacy will be determined by measuring % days abstinent and secondary outcomes include rates of complete abstinence, % heavy drinking days, CGI and GGT in the acamprosate group compared to the placebo group.

Arms: arm 1: The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit. arm 2: The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
Interventions: intervention 1: Acamprosate (Campral)
Intervention descriptions: intervention 1: The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.

Protocol documents:
Clinical trial NCT00381862
Conditions: Colorectal Cancer Nausea and Vomiting
Keywords: nausea and vomiting recurrent colon cancer stage IV colon cancer recurrent rectal cancer stage IV rectal cancer
Sponsor: OHSU Knight Cancer Institute
Start date: 2006-06-01; Completion date: 2008-07-01
Enrollment: 54 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Aprepitant, palonosetron, and dexamethasone may help lessen or prevent nausea and vomiting in patients receiving chemotherapy.

PURPOSE: This phase II trial is studying how well giving aprepitant together with palonosetron and dexamethasone works in preventing nausea and vomiting caused by chemotherapy in patients receiving chemotherapy for metastatic colorectal cancer.

Detailed description:
OBJECTIVES:

Primary

* Evaluate the efficacy, in terms of nausea and vomiting control, of aprepitant, palonosetron hydrochloride, and dexamethasone, in preventing chemotherapy-induced nausea and vomiting in patients receiving FOLFOX or FOLFIRI chemotherapy for metastatic colorectal cancer.

Secondary

* Assess the percentage of patients with no emesis and no rescue therapy when treated with aprepitant, palonosetron hydrochloride, and dexamethasone during repeated courses of FOLFOX or FOLFIRI chemotherapy.
* Assess the effects of aprepitant on nausea, appetite, taste changes (via visual analogue scale), nutritional intake, and mucositis in these patients.
* Assess the safety of this regimen in these patients.

OUTLINE: This is an open-label, multicenter study.

Beginning 1 hour prior to the initiation of chemotherapy on day 1, patients receive oral aprepitant on days 1-3, oral dexamethasone on days 1-4, and palonosetron hydrochloride IV on day 1.

Nausea is assessed daily for up to 4 courses of chemotherapy.

Quality of life is assessed at baseline.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Arms: arm 1: None
Interventions: intervention 1: aprepitant intervention 2: dexamethasone intervention 3: fluorouracil intervention 4: irinotecan hydrochloride intervention 5: leucovorin calcium intervention 6: oxaliplatin intervention 7: palonosetron hydrochloride intervention 8: quality-of-life assessment
Intervention descriptions: intervention 1: Aprepitant 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle intervention 2: Dexamethasone 12 mg PO on 1st day of study drug and 8 mg PO on days 2-4 intervention 3: as per institutional standard of care intervention 4: as per institutional standard of care intervention 5: as per institutional standard of care intervention 6: as per institutional standard of care intervention 7: Palonosetron 0.25 mg IV push on day 1 only. intervention 8: baseline

Protocol documents:
Clinical trial NCT00385268
Conditions: Cocaine Dependence
Keywords: cocaine
Sponsor: University of Pennsylvania
Start date: 2006-11-01; Completion date: 2008-07-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Trial to determine the safety, efficacy and tolerability of acamprosate for the treatment of cocaine dependence.

Detailed description:
The primary objective of the trial is to evaluate the safety, tolerability and efficacy of acamprosate for the treatment of 60 treatment seeking cocaine dependent outpatients. The study will be an exploratory, double-blind, placebo-controlled 9-week trial, with a 2-cell design (30 subjects per cell) in which either 1998 mg/day of acamprosate (666 mg TID) or placebo will be given. Study medications will be given by medical practitioners, trained to provide NIAAA's COMBINE Medical Management. In addition, patients will receive weekly individual psychosocial treatment sessions utilizing Cognitive Behavioral Therapy (CBT) at the University of Pennsylvania Treatment Research Center (TRC).

Primary Hypotheses:

1. Efficacy: Acamprosate-treated subjects will demonstrate less cocaine use during the medication/placebo treatment phase, compared to placebo-treated subjects. Cocaine use will be measured by self-report from the TLFB confirmed with urine assay for benzoylecgonine (BE)
2. Safety and Tolerability: Acamprosate-treated subjects and placebo-treated subjects will report similar rates of adverse events, assessed by weekly evaluations, physical exams and laboratory testing.

Secondary Hypotheses:

1. Acamprosate-treated subjects, compared to placebo-treated subjects, will report less craving for cocaine, measured by lower scores on the Brief Substance Craving Scale (BSCS) (Somoza et al, 1995) and Multiple Choice Procedure (MCP) (Griffiths et al., 1993) during the medication treatment phase.
2. Acamprosate-treated subjects, compared to placebo-treated subjects, will report fewer withdrawal symptoms, measured by the Cocaine Selective Severity Assessment (Kampman et al., 1998).
3. Acamprosate-treated subjects, compared to placebo-treated subjects, will report fewer mood and anxiety symptoms, measured by the Hamilton Depression Rating Scale (HAM-D) (Hamilton, 1967), Hamilton Anxiety Rating Scale (HAM-A) (Hamilton, 1969), and Clinical Global Impression Scale (CGI).
4. Subjects who are highly acamprosate-adherent (\>80% pills taken, verified by combining patient report with blister cards) will have more cocaine non-use days during the medication treatment phase, compared to those who are less acamprosate-adherent (\<80% pills taken).

Arms: arm 1: 1998mg/day for 8 weeks arm 2: placebo pills for 8 weeks
Interventions: intervention 1: acamprosate intervention 2: placebo
Intervention descriptions: intervention 1: 1998 mg/dau fpr 8 weeks intervention 2: placebo pills

Protocol documents:
Clinical trial NCT00395044
Conditions: Cannabis Dependence
Keywords: Cannabis treatment marijuana treatment
Sponsor: The Scripps Research Institute
Start date: 2006-08-01; Completion date: 2008-07-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to evaluate the efficacy of the medication gabapentin in treating persons with cannabis dependence.

Detailed description:
This is a 12-week, double blind, placebo controlled, dose ranging study to evaluate the efficacy of gabapentin in treating outpatients with cannabis dependence. Counseling and research assessments occur weekly throughout the 12-week treatment phase.

Arms: arm 1: 1200 mg/daily of Gabapentin arm 2: 1200mg/d of Placebo
Interventions: intervention 1: Placebo intervention 2: Gabapentin
Intervention descriptions: intervention 1: Placebo intervention 2: None

Protocol documents:
Clinical trial NCT00409539
Conditions: Overactive Bladder Syndrome (OABS)
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2006-12-01; Completion date: 2008-07-01
Enrollment: 550 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
SMP-986 is a compound being developed for the treatment of overactive bladder syndrome (OABS). This clinical study is designed to test the hypothesis that SMP-986 at doses of 20mg, 40mg, 80mg or 120mg provides greater symptom relief in OABS compared to placebo. The hypothesis will be tested by measuring the change in mean voids/24 hrs after treatment with SMP-986 compared to placebo, as well comparing the change in: the severity of urgency episodes, mean number of urgency episodes/24 hr, mean number of incontinence episodes/24 hr and the mean void volume/void between SMP-986 and placebo.

Detailed description:
A multicenter study conducted in patients with OABS comprising a 2-week single blind placebo run-in period followed by an 8-week randomized, double-blind, placebo controlled treatment period with patients randomized to receive 20 mg, 40 mg, 80 mg or 120 mg SMP 986 or placebo in a 1:1:1:1:1 ratio in parallel groups on an outpatient basis with study center visits.

Arms: arm 1: Placebo run-in phase. 2 week duration. arm 2: To be taken for the 8 week duration, in parallel with alternative arms (doses of 20, 40, 80 or 120mg SMP-986). arm 3: 20mg dose of SMP-986 to be taken once daily for 8 week duration. arm 4: 40mg dose of SMP-986 to be taken for 8 week duration. arm 5: 80mg dose of SMP-986 to be taken for 8 week duration. arm 6: 120mg dose of SMP-986 to be taken for 8 week duration.
Interventions: intervention 1: Placebo intervention 2: Placebo intervention 3: SMP-986
Intervention descriptions: intervention 1: Placebo, 2 week duration. intervention 2: Taken for the 8 week duration, in parallel with alternative arms (doses of 20, 40, 80 or 120mg SMP-986). intervention 3: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks

Protocol documents:
Clinical trial NCT00415519
Conditions: Amyotrophic Lateral Sclerosis (ALS)
Keywords: Amyotrophic lateral sclerosis free radical scavenger
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2006-12-01; Completion date: 2008-07-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the efficacy of 60mg of MCI-186 via intravenous drip once a day in patients with ALS whose severity is classified as grade III, based on the changes in the revised ALS functional rating scale (ALSFRS-R) scores after 24 weeks administration in double-blind, placebo-controlled manner. And in addition, this study will be performed to examine the safety of MCI-186 to ALS patients who met severity classification III.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: MCI-186 intervention 2: Placebo of MCI-186
Intervention descriptions: intervention 1: Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles). intervention 2: Two ampoules of Placebo injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).

Protocol documents:
Clinical trial NCT00424268
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD Roflumilast
Sponsor: AstraZeneca
Start date: 2007-01-01; Completion date: 2008-07-01
Enrollment: 743 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to compare the efficacy of roflumilast to placebo on pulmonary function and symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during concomitant administration of tiotropium. The study duration will last up to 28 weeks. The study will provide further data on safety and tolerability of roflumilast.

Detailed description:

Arms: arm 1: Roflumilast 500 µg

underlying medication: tiotropium 18 µg, once daily, inhaled arm 2: Placebo

underlying medication: tiotropium 18 µg, once daily, inhaled
Interventions: intervention 1: Roflumilast intervention 2: Placebo
Intervention descriptions: intervention 1: 500 µg, once daily, oral administration in the morning intervention 2: once daily

Protocol documents:
Clinical trial NCT00430300
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Dry Powder for Inhalation Chronic Obstructive Pulmonary Disease Lung Function testing
Sponsor: Pfizer
Start date: 2007-01-01; Completion date: 2008-07-01
Enrollment: 87 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Safety and efficacy (measured by spirometry) of UK-432,097 administration will be tested in patients with chronic obstructive pulmonary disease.

Detailed description:

Arms: arm 1: Active treatment given BID via a double pin monodose capsule inhaler device arm 2: Placebo treatment given BID via a single pin monodose inhaler device
Interventions: intervention 1: UK-432,097 intervention 2: Placebo
Intervention descriptions: intervention 1: Formulated as a dry powder, supplied as capsules and administered using an atomizer device. Given as either 150mcg, 450mcg or 1350mcg BID. intervention 2: Capsules containing 100% lactose administered BID using an atomizer device

Protocol documents:
Clinical trial NCT00431444
Conditions: Osteoporosis
Keywords: Osteoporosis Post-menopausal Bone mineral density
Sponsor: Novartis
Start date: 2007-01-01; Completion date: 2008-07-01
Enrollment: 110 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the effects of Zoledronic acid and Raloxifene in reducing bone turnover markers in postmenopausal women with low bone mineral density over 6 months.

Detailed description:

Arms: arm 1: Zoledronic acid 5 mg (single i.v. infusion) + daily oral placebo for 6 months (zoledronic acid group) arm 2: Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
Interventions: intervention 1: Raloxifene intervention 2: Zoledronic acid intervention 3: Placebo oral pills intervention 4: Placebo intravenous (i.v.) infusion
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00434213
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Noven Therapeutics
Start date: 2007-01-01; Completion date: 2008-07-01
Enrollment: 309 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a study designed to characterize the dermal response of DAYTRANA. Subjects will visit the study site over a period of approximately 14 weeks.

Detailed description:
This is a study designed to characterize the dermal response of DAYTRANA. Subjects will visit the study site over a period of approximately 14 weeks. Subjects will be titrated to an optimum dose of study treatment and assessed for safety and efficacy. Dermal response will be evaluated at each visit by the investigator. Subjects with high dermal response scores or scores that persist at the same application site and have no improvement after up to 4 evaluations (not to exceed a two week period) will be discontinued from the study and referred to a study specific dermatologist for specialized skin sensitivity skin patch testing.

Arms: arm 1: To characterize the dermal reactions seen with the use of DAYTRANA
Interventions: intervention 1: Daytrana
Intervention descriptions: intervention 1: Methylphenidate Transdermal System (MTS)

Protocol documents:
Clinical trial NCT00440518
Conditions: Migraine
Keywords: Lacosamide migraine prophylaxis Vimpat
Sponsor: UCB Pharma
Start date: 2007-02-01; Completion date: 2008-07-01
Enrollment: 218 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see how safe and effective Lacosamide (LCM) is when taken by mouth, twice a day for up to 18 weeks to prevent migraines.

Detailed description:
This study is for subjects who have been diagnosed with migraine for at least one year and who are currently taking an effective abortive medication(s).

Arms: arm 1: Placebo arm 2: 100mg lacosamide arm 3: 300mg lacosamide
Interventions: intervention 1: Lacosamide intervention 2: Placebo intervention 3: Lacosamide
Intervention descriptions: intervention 1: Lacosamide 100mg immediate-release film-coated tablet (white,oval) oral administration twice daily 12 hours apart intervention 2: Immediate-release film coated tablet (white, oval), oral administration twice daily 12 hours apart intervention 3: Lacosamide 300mg, immediate-release film coated tablet (white,oval), oral administration twice daily 12 hours apart.

Protocol documents:
Clinical trial NCT00441883
Conditions: Primary Open Angle Glaucoma Ocular Hypertension Pigmentary Glaucoma Pseudoexfoliative Glaucoma
Sponsor: Bausch & Lomb Incorporated
Start date: 2007-03-01; Completion date: 2008-07-01
Enrollment: 176 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of PF 03187207.

Detailed description:

Arms: arm 1: One drop of each, once daily in study eye for 28 days arm 2: One drop of each, once daily in study eye for 28 days
Interventions: intervention 1: PF-03187207 and Latanoprost Vehicle intervention 2: Latanoprost 0.005% and PF-03187207 Vehicle
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00444626
Conditions: Facial Wrinkles at the Nasolabial Folds
Keywords: nasolabial folds facial wrinkles
Sponsor: Genzyme, a Sanofi Company
Start date: 2007-05-01; Completion date: 2008-07-01
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to evaluate the safety and effectiveness of injection with DGE Injectable Gel (hyaluronic acid with lidocaine manufactured by Genzyme Biosurgery) as compared to injection with Restylane (a Food and Drug Administration (FDA) approved dermal filler) in patients undergoing cutaneous correction of the nasolabial folds (NLFs).

Detailed description:
This study included an Initial and a Repeat Treatment period.

The Initial Treatment period was a subject and evaluator-blinded, randomized split face study in which subjects received DGE in one nasolabial fold and Restylane in the other nasolabial fold. Both safety and efficacy were evaluated.

In the Repeat Treatment Period, participants received DGE in both NLFs. Safety was evaluated.

Arms: arm 1: Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment period were treated with DGE as an open-label treatment. arm 2: Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
Interventions: intervention 1: Dermal Gel Extra (DGE) intervention 2: Restylane intervention 3: EMLA Cream
Intervention descriptions: intervention 1: Dermal Gel Extra (DGE) Injectable Gel contains hyaluronic acid with lidocaine. DGE was administered to nasolabial folds via the intradermal route. The Principal Investigator was instructed to inject a sufficient amount of DGE to ensure full correction of the NLF wrinkles (i.e., to the optimal level of correction achievable). Up to 2 touch-up treatments were allowed in the Initial Treatment period. intervention 2: Restylane was administered to nasolabial folds via the intradermal route. The Principal Investigator was instructed to inject a sufficient amount of Restylane to ensure full correction of the NLF wrinkles (i.e., to the optimal level of correction achievable). Up to 2 touch-up treatments were allowed in the Initial Treatment period. intervention 3: EMLA Cream (Eutectic Mixture of Local Anesthetics) is an FDA-approved topical anesthetic comprised of 2.5% each of lidocaine/prilocaine. EMLA Cream was applied in approximately equal amounts prior to all injections of DGE and Restylane.

Protocol documents:
Clinical trial NCT00446641
Conditions: Cerebral Infarction
Keywords: Infarction, Cerebral Cilostazol Aspirin Resistance
Sponsor: Asan Medical Center
Start date: 2007-03-01; Completion date: 2008-07-01
Enrollment: 244 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will recruit 316 ischemic stroke patients taking aspirin.

They will be randomly assigned into cilostazol group or placebo group. Every patients will take 200mg of cilostazol a day or placebo for 1 month.

The primary outcome variable of this study is rate of biochemical aspirin resistance on the Ultra Rapid Platelet Function Assay-ASA.

Detailed description:
\[Goal\] To reveal the effect and safety of additional cilostazol for overcoming biochemical aspirin resistance.

\[Trial Design\] Double-Blind, Placebo-Controlled, Randomized, Multicenter Trial

\[Participants\] Ischemic stroke patients taking aspirin

\[Methods\]

* Double-Blind, Placebo-Controlled, Randomized, Multicenter Trial
* Investigational product: Cilostazol 200mg (100mg twice per day)
* Concomitant medication: Aspirin 100 mg per day
* Medication Duration: 1 month

\[Outcome Variables\]

Primary Outcome Variable:

• the proportion of patients with aspirin reaction units (ARUs) values ≥550 on the Ultra Rapid Platelet Function Assay-ASA

Secondary outcome variables:

* the proportion of patients with ARUs values ≥500 on the Ultra Rapid Platelet Function Assay-ASA
* ARUs values
* Bleeding time (BT)
* Fatal or major bleeding complications
* Any bleeding complications

Arms: arm 1: 100mg of Cilostazol twice a day arm 2: matching placebo to cilostazol
Interventions: intervention 1: Cilostazol intervention 2: placebo
Intervention descriptions: intervention 1: cilostazol 100mg twice a day for 4 weeks intervention 2: placebo 1 tablet twice a day matching for cilostazol

Protocol documents: