ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00713661
Conditions: Colorectal Anastomosis
Keywords: Colorectal Anastomosis Colorectal Resection Tachosil
Sponsor: Nycomed
Start date: 2008-06-01; Completion date: 2010-07-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective is to evaluate if the application of TachoSil® on a colorectal anastomosis is feasible and safe.

The secondary objective is to establish and describe optimal application methods to be used for educational purposes in future trials.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: TachoSil®
Intervention descriptions: intervention 1: Sterile, ready-to-use, absorbable sponge for intra-operative topical application. It consists of an equine collagen sponge coated with the fibrin glue components human fibrinogen and human thrombin.

Surgery was performed according to the hospitals' local standards. When the anastomosis was performed, all enrolled subjects had TachoSil® applied around the anastomotic line. TachoSil® was therefore an add-on therapy.

Protocol documents:
Clinical trial NCT00717860
Conditions: Fungal Infection
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-08-01; Completion date: 2010-07-01
Enrollment: 121 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the safety and efficacy of MK0991 in patients with deep-seated mycoses.

Detailed description:

Arms: arm 1: caspofungin acetate (MK0991) arm 2: Micafungin sodium
Interventions: intervention 1: caspofungin acetate intervention 2: Comparator: Micafungin sodium
Intervention descriptions: intervention 1: Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis. intervention 2: Micafungin sodium 150 mg/day, once daily IV, for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.

Protocol documents:
Clinical trial NCT00736190
Conditions: Chronic Hepatitis B
Keywords: Hepatitis B Hepatitis Tenofovir disoproxil fumarate Tenofovir DF Asian-American
Sponsor: Gilead Sciences
Start date: 2008-08-01; Completion date: 2010-07-01
Enrollment: 90 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the antiviral activity and safety of tenofovir disoproxil fumarate (TDF) in Asian-American adults (self-reported Asian descent, living in the United States) with chronic hepatitis B infection. All participants will receive active treatment with TDF for 48 weeks.

Detailed description:
Efficacy of TDF will be evaluated for reductions in serum HBV DNA, changes in liver enzymes, and the generation of antibody to the virus. Safety will be assessed by evaluating adverse events, laboratory abnormalities, and the development of drug resistance mutations.

Arms: arm 1: 300-mg tablet (marketed formulation) taken orally once daily
Interventions: intervention 1: Tenofovir disoproxil fumarate
Intervention descriptions: intervention 1: 300-mg tablet (marketed formulation) taken orally once daily

Protocol documents:
Clinical trial NCT00744237
Conditions: Hypertension Type 2 Diabetes Mellitus
Keywords: nebivolol Bystolic ™ Hypertension Diabetes
Sponsor: Forest Laboratories
Start date: 2008-08-01; Completion date: 2010-07-01
Enrollment: 231 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the effects of nebivolol on glycemic control compared with metoprolol and HCTZ in patients with hypertension and type 2 diabetes mellitus

Detailed description:

Arms: arm 1: * Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration
* Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration
* Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration
* Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration
* Open-label amlodipine may be given arm 2: * Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration
* Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration
* Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration
* Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration
* Open-label amlodipine may be given arm 3: * HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration
* HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration
* Open-label amlodipine may be given
Interventions: intervention 1: Nebivolol intervention 2: Metoprolol ER intervention 3: HCTZ
Intervention descriptions: intervention 1: * Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration
* Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration
* Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration
* Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration intervention 2: * Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration
* Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration
* Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration
* Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration intervention 3: * HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration
* HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration

Protocol documents:
Clinical trial NCT00746239
Conditions: Panic Disorder Insomnia
Keywords: insomnia sleep difficulty panic disorder nocturnal panic attacks anxiety
Sponsor: Milton S. Hershey Medical Center
Start date: 2008-08-01; Completion date: 2010-07-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Almost 80% of panic disorder patients report difficulty sleeping. Sleep disturbances in turn may exacerbate underlying anxiety/panic attacks. Moreover, individuals with insomnia (sleep disturbance) are at higher risk of developing a new anxiety disorder. Therefore it is expected that improving sleep quality with medications along with other medications to treat anxiety component of panic disorder might be helpful. However, there is lack of pharmacological studies examining the effects of improving sleep disturbances with medications in panic disorder patients, which is a critical problem for providing optimal care to these patients. The objective of this proposal is to determine the effects of ramelteon (FDA approved for insomnia) on sleep disturbances in Panic disorder patients who are on escitalopram for underlying anxiety.

Detailed description:

Arms: arm 1: Subjects will be randomly assigned to receive either Ramelteon and Escitalopram OR Placebo and Escitalopram. arm 2: Subjects will be randomly assigned to receive either Ramelteon and Escitalopram OR Placebo and Escitalopram.
Interventions: intervention 1: Placebo and Escitalopram intervention 2: Ramelteon and Escitalopram
Intervention descriptions: intervention 1: Placebo and Escitalopram (5 to 40 mg) intervention 2: Ramelteon 8 mg and Escitalopram (5-40 mg)

Protocol documents:
Clinical trial NCT00751023
Conditions: Methamphetamine Dependence
Keywords: Methamphetamine Modafinil Addiction Craving Cognitive
Sponsor: Medical University of South Carolina
Start date: 2009-02-01; Completion date: 2010-07-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Methamphetamine dependence is a serious public health problem with no pharmacologic treatments currently available. Relapse rates are high in this population. Exposure to cues previously associated with methamphetamine use may induce profound craving in abstinent individuals. Chronic methamphetamine abuse is associated with selective cognitive deficits that may undermine successful participation in psychosocial treatments. Medications which improve cognitive deficits in methamphetamine-dependent individuals may improve abstinence rates, especially in the critical early period of recovery. Modafinil is an atypical stimulant medication with evidence to support its use in treating cocaine dependence and attention deficit/hyperactivity disorder. The proposed studies are designed to evaluate modafinil as a potential treatment for methamphetamine dependence and its cognitive sequelae.

Detailed description:

Arms: arm 1: Modafinil 400 mg daily arm 2: Placebo
Interventions: intervention 1: Modafinil intervention 2: Placebo
Intervention descriptions: intervention 1: 400 mg daily for four weeks intervention 2: Placebo 2 tablets daily for 4 weeks

Protocol documents:
Clinical trial NCT00755326
Conditions: Osteoarthritis of the Knee
Keywords: OA
Sponsor: University of Maryland, Baltimore
Start date: 2007-04-01; Completion date: 2010-07-01
Enrollment: 92 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if the traditional Chinese herbal compound (Huo-Luo-Xiao-Ling Dan, or HLXL) is effective in treating OA of the knee in addition to participants current OA of the knee treatment(s) and also to determine the best dosage of HLXL that is safe and well tolerated.

Detailed description:
The specific aims of this project are:

1. To determine whether HLXL improves pain and/or function in patients with OA of the knee who continue to have symptoms despite receiving standard analgesic and/or anti-inflammatory treatment,
2. To identify an optimal dosage of HLXL, among two dosages, as determined by pain relief and/or functional improvement, in a dose-escalation, placebo-controlled double-blind randomized phase II clinical trial, in conjunction with indicia of safety and tolerability in patients with OA of the knee who are receiving standard analgesic and/or anti-inflammatory treatment,
3. To explore mechanisms of action of HLXL, correlating changes in biological markers of suppression of systemic inflammation with changes in clinical response

Arms: arm 1: Active herb Huo-Luo-Xiao-Ling (HLXL) The subjects in the HLXL group received the medium dose of HLXL (10 capsules/day or 4,000mg/day) in the first 2 weeks to evaluate safety. If no adverse effects were observed, the dose was increased to 14 capsules per day (5,600 mg/day) for the subsequent 6 weeks. arm 2: Placebo Huo-Luo-Xiao-Ling (HLXL): Subjects in the placebo group received an equal number of placebo capsule.
Interventions: intervention 1: HLXL
Intervention descriptions: intervention 1: Two daily dosages will be investigated. Huo-Luo-Xiao-Ling (HLXL) dose (10 capsules/day or 4,000mg/day) in the first 2 weeks to evaluate safety. If no adverse effects were observed, the dose was increased to 14 capsules per day (5,600 mg/ day) for the subsequent 6 weeks.

Protocol documents:
Clinical trial NCT00758043
Conditions: Hepatitis C
Keywords: Genotype 1
Sponsor: Vertex Pharmaceuticals Incorporated
Start date: 2008-10-01; Completion date: 2010-07-01
Enrollment: 540 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to learn more about the safety and effect of telaprevir in combination with peginterferon alfa-2a (PEG-IFN) and ribavirin (RBV) in participants with hepatitis C who have never been treated for their hepatitis C virus (HCV). The study is designed to look at the relative benefits of 24 or 48 weeks of total treatment in people who respond quickly to a telaprevir-based treatment.

Detailed description:

Arms: arm 1: Randomized Group: Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 12 weeks; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group arm 2: Randomized Group: Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 36 weeks; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group arm 3: Assigned Group: Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 36 weeks; subjects did not achieve an extended rapid viral response and were assigned to this group arm 4: Other Group: Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20, were not randomized or assigned to a treatment regimen.
Interventions: intervention 1: telaprevir intervention 2: ribavirin intervention 3: peginterferon alfa-2a
Intervention descriptions: intervention 1: 750 mg every 8 hours (q8h) for 12 weeks intervention 2: 1000 - 1200 mg/day based on body weight for either 24 or 48 weeks intervention 3: 180 mcg/week for either 24 or 48 weeks

Protocol documents:
Clinical trial NCT00764881
Conditions: Contraception Libido
Keywords: Oral contraceptive Sexual dysfunction Libido
Sponsor: Bayer
Start date: 2009-01-01; Completion date: 2010-07-01
Enrollment: 217 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to investigate whether women on oral contraceptives (OCs) suffering from acquired OC-associated female sexual dysfunction (FSD) for at least 3 months but no longer than one year will express the same level of sexual distress when taking SH T00658ID compared to Microgynon, the usual OC prescribed for women with OC-associated FSD.

Detailed description:

Arms: arm 1: Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles. arm 2: Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Interventions: intervention 1: EV/DNG (Qlaira, BAY86-5027, SH T00658ID) intervention 2: Microgynon intervention 3: Placebo
Intervention descriptions: intervention 1: Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one encapsulated SH T00658ID for 28 days per cycle, for 6 treatment cycles: Days 1-2, 3.0 mg EV; Days 3-7, 2.0 mg EV+2.0 mg DNG; Days 8-24, 2.0 mg EV+3.0 mg DNG; Days 25-26, 1.0 mg EV; Days 27-28, placebo, encapsulated for blinding purpose intervention 2: Days 1 to 21: daily oral administration of one encapsulated Microgynon tablet; 0.03 mg ethinylestradiol (EE) + 0.15 mg levonorgestrel (LNG). Six 28-day treatment cycles. intervention 3: Days 22 to 28: daily oral administration of one encapsulated placebo tablet. Six 28-day treatment cycles.

Protocol documents:
Clinical trial NCT00771745
Conditions: Renal Transplant Rejection Transplants and Implants
Sponsor: University of Cincinnati
Start date: 2008-09-01; Completion date: 2010-07-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine how safe and effective giving Thymoglobulin before transplantation to patients who are going to be receiving kidney transplants.

Detailed description:
We will evaluate the therapeutic efficacy of administering Thymoglobulin® induction pre-transplantation in renal allograft recipients. Patients receiving pre-transplant Thymoglobulin will be evaluated for acute rejection (Banff '97 criteria), survival, and safety at 6 months. Overall the use of Thymoglobulin induction pre-transplantation will be safe and effective.

Arms: arm 1: Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF arm 2: Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF
Interventions: intervention 1: Thymoglobulin intervention 2: Thymoglobulin
Intervention descriptions: intervention 1: Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF intervention 2: Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF

Protocol documents:
Clinical trial NCT00781274
Conditions: Hepatitis C
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2008-12-01; Completion date: 2010-07-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and RBV in patients with (Genotype 1) hepatitis C, who did not respond to previous treatment.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: MP-424 intervention 2: Ribavirin intervention 3: Peginterferon Alfa-2b
Intervention descriptions: intervention 1: 750 mg every 8 hours for 12 weeks intervention 2: 600 - 1000 mg/day based on body weight for 24 weeks intervention 3: 1.5 mcg/kg/week for 24 weeks

Protocol documents:
Clinical trial NCT00782717
Conditions: Macular Edema
Keywords: diabetic retinopathy cystoid macular edema;
Sponsor: Alcon Research
Start date: 2008-11-01; Completion date: 2010-07-01
Enrollment: 263 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether nepafenac is safe and effective for reducing the incidence of macular edema following cataract surgery in diabetic retinopathy patients.

Detailed description:

Arms: arm 1: One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter. arm 2: One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
Interventions: intervention 1: Nepafenac ophthalmic suspension, 0.1% (NEVANAC) intervention 2: Nepafenac ophthalmic suspension vehicle intervention 3: Prednisolone acetate ophthalmic suspension (OMNIPRED)
Intervention descriptions: intervention 1: 1 drop TID beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery. intervention 2: 1 drop TID beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery intervention 3: One drop in the study eye 4 times daily (morning, late morning, late afternoon, and bedtime)for two weeks postsurgery.

Protocol documents:
Clinical trial NCT00787917
Conditions: Cystic Fibrosis Allergic Bronchopulmonary Aspergillosis
Keywords: Cystic Fibrosis Allergic Bronchopulmonary Aspergillosis omalizumab oral corticosteroid use anti-immunoglobulin E
Sponsor: Novartis Pharmaceuticals
Start date: 2008-11-01; Completion date: 2010-07-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of omalizumab for the treatment of Allergic Bronchopulmonary Aspergillosis (ABPA) in patients with Cystic Fibrosis aged 12 years and older.

Detailed description:

Arms: arm 1: Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.

Participants who completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase. arm 2: Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
Interventions: intervention 1: Omalizumab intervention 2: Placebo intervention 3: Itraconazole
Intervention descriptions: intervention 1: Omalizumab subcutaneous injections of 600 mg daily. intervention 2: Placebo subcutaneous injections blinded to match experimental arm dosing regimen. intervention 3: Itraconazole twice daily with a maximum daily dose of 400 mg.

Protocol documents:
Clinical trial NCT00788710
Conditions: Acute Pain Following a Total Abdominal Hysterectomy
Sponsor: Organon and Co
Start date: 2008-10-01; Completion date: 2010-07-01
Enrollment: 430 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of etoricoxib compared to placebo in the treatment of postoperative pain associated with total abdominal hysterectomy.

Detailed description:

Arms: arm 1: etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days. arm 2: etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days. arm 3: Placebo- 3 tablets once daily
Interventions: intervention 1: etoricoxib (MK0663) 120 mg intervention 2: Comparator: Placebo intervention 3: etoricoxib (MK0663) 90 mg
Intervention descriptions: intervention 1: 120 mg of etoricoxib (MK0663) for a total of 5 days intervention 2: Placebo tablets once daily on Days 1-5. Total treatment is 5 days. intervention 3: 90 mg of etoricoxib (MK0663) for a total of 5 days

Protocol documents:
Clinical trial NCT00790192
Conditions: Schizophrenia
Keywords: Schizophrenia SM-13496 Latuda Lurasidone
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2008-10-01; Completion date: 2010-07-01
Enrollment: 488 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe as compared with quetiapine XR short term among acutely psychotic patients with chronic schizophrenia.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Lurasidone intervention 2: Lurasidone intervention 3: Quetiapine XR intervention 4: Placebo
Intervention descriptions: intervention 1: Lurasidone 80 mg tablets intervention 2: Lurasidone 4 40 mg tablets intervention 3: Quetiapine XR 600mg intervention 4: Matching Placebo to Lurasidone or Quetiapine

Protocol documents:
Clinical trial NCT00796367
Conditions: Obesity
Keywords: Obesity
Sponsor: VIVUS LLC
Start date: 2008-12-01; Completion date: 2010-07-01
Enrollment: 676 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the long-term safety and efficacy of VI-0521 compared to placebo for the treatment of overweight and obesity in adults who have completed study OB-303 (NCT00553787) at selected study sites. This is an extension study of protocol OB-303 (NCT00553787).

Detailed description:

Arms: arm 1: Placebo arm 2: 7.5 mg phentermine and 46 mg topiramate arm 3: 15 mg phentermine and 92 mg topiramate
Interventions: intervention 1: VI-0521 intervention 2: Placebo intervention 3: VI-0521
Intervention descriptions: intervention 1: 7.5 mg phentermine and 46 mg topiramate intervention 2: placebo intervention 3: 15 mg phentermine and 92 mg topiramate

Protocol documents: