ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00246441
Conditions: Social Anxiety Disorder Social Phobia Alcohol Use Disorder Alcohol Abuse Alcohol Dependence
Keywords: Pharmacotherapy Self medication
Sponsor: Medical University of South Carolina
Start date: 2002-03-01; Completion date: 2008-02-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine whether an SSRI, paroxetine, improves social anxiety symptoms and alcohol use in individuals who drink to cope with social anxiety disorder.

Detailed description:
Social anxiety disorder (also known as social phobia) is an Axis I anxiety disorder characterized by intense fear and avoidance of social or performance situations in which one might be scrutinized. Its onset is typically in the early teen years. It is the third most common mental disorder in the United States, exceeded in prevalence only by depression and alcoholism. Approximately 20% of the individuals with social anxiety disorder have alcohol problems. Anecdotal and empirical evidence suggests that alcohol is used by some socially anxious individuals to self-medicate anxiety symptoms, a practice that could lead to alcohol abuse and/or dependence. The proposed project further explores the self-medication hypothesis through the use of a double-blind, randomized, placebo-controlled clinical trial. Paroxetine (a selective serotonin reuptake inhibitor) is the drug to be used in the study. Individuals who drink alcohol to cope with social anxiety symptoms and who meet DSM-IV criteria for the dual-diagnoses of social anxiety disorder and alcohol use disorders will be enrolled in the trial. All individuals will be seeking treatment for social anxiety disorder. The treatment phase will last 16 weeks. Dosing will start at 20 mg/day (paroxetine or placebo) and will increase gradually to a maximum dose of 60 mg/day. Each week during treatment and at the end of the trial, assessments will be made with standard instruments to determine the effect of paroxetine (versus placebo) on social anxiety severity, alcohol use, and more specifically, the intentional use of alcohol to cope with social anxiety symptoms. Additionally, 6 month and 12 month follow-up interviews will be conducted. The overarching hypothesis is that because paroxetine will improve social anxiety severity, alcohol use and/or alcohol use for coping will also be reduced in the paroxetine-treated group.

Arms: arm 1: Active medication containing the drug Paroxetine arm 2: A Placebo medication that appears just like the active medication but does not contain placebo
Interventions: intervention 1: Paroxetine intervention 2: Placebo
Intervention descriptions: intervention 1: 16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day intervention 2: treatment phase will last 16 weeks; dosing will start at 20 mg/day (placebo) and will increase gradually to a maximum dose of 60 mg/day.

Protocol documents:
Clinical trial NCT00264641
Conditions: Hypoglycemia Cognitive Impairment
Keywords: Hypoglycemia Cognitive impairment PET CalCAP
Sponsor: Hypoglycaemia Research Group
Start date: 2006-01-01; Completion date: 2008-02-01
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the cerebral blood flow in subjects with high and low activity in the renin-angiotensin system (RAS).The renin-angiotensin system is a hormone system which is involved in the regulation of the blood pressure. Earlier studies have shown that high RAS activity is associated with a more pronounced cognitive impairment during hypoglycaemia compared to low RAS activity in both type 1 diabetic patients and healthy volunteers. We intend to examine brain activity by oxygen-15 labelled water-PET scanning during hypoglycaemia in response to cognitive function testing in 20 healthy male volunteers with high and low RAS activity, respectively

Detailed description:
The purpose of this study is to evaluate the regional cerebral blood flow in subjects with high and low activity in the renin-angiotensin system (RAS). Earlier studies have shown that high RAS activity is associated with a more pronounced cognitive impairment during hypoglycaemia compared to low RAS activity in both type 1 diabetic patients and healthy volunteers. We intend to examine brain activity by oxygen-15 labelled water-PET scanning during hypoglycaemia in response to cognitive function testing in 20 healthy male volunteers with high and low RAS activity, respectively.

Arms: arm 1: 10 healthy men were characterized by having high basal RAS activity. arm 2: 10 healthy men were characterized by having either a low basal RAS activity.
Interventions: intervention 1: Human insulin
Intervention descriptions: intervention 1: Hyperinsulinaemic induced hypoglycaemia

Protocol documents:
Clinical trial NCT00282919
Conditions: Falciparum Malaria
Sponsor: Pfizer
Start date: 2006-03-01; Completion date: 2008-02-01
Enrollment: 110 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The treatment of symptomatic, uncomplicated malaria caused by P. falciparum in adults.

Detailed description:

Arms: arm 1: Single Arm, Open label study
Interventions: intervention 1: Azithromycin plus chloroquine
Intervention descriptions: intervention 1: dose of 2000 mg Azithromycin plus 600 mg chloroquine base

Protocol documents:
Clinical trial NCT00306787
Conditions: Genital Herpes
Keywords: Herpes simplex genital herpes famciclovir valacyclovir Recurrent genital herpes
Sponsor: Novartis Pharmaceuticals
Start date: 2006-03-01; Completion date: 2008-02-01
Enrollment: 1179 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the safety and efficacy of one-day famciclovir (1000 mg twice a day (b.i.d)) in reducing the duration of genital herpes lesions and the associated symptoms compared to three-day treatment with valacyclovir (500 mg capsule b.i.d).

Detailed description:

Arms: arm 1: Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart. arm 2: Patients received Valacyclovir 500 mg capsule twice a day approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
Interventions: intervention 1: Famciclovir intervention 2: Valacyclovir intervention 3: Placebo matching famciclovir intervention 4: Placebo matching valacyclovir
Intervention descriptions: intervention 1: Famciclovir 500 mg tablet intervention 2: Valacyclovir 500 mg capsule intervention 3: Famciclovir placebo, matching in size, color and forms of famciclovir tablet. intervention 4: Valacyclovir placebo, matching in size, color and forms of valacyclovir capsule.

Protocol documents:
Clinical trial NCT00313209
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Roflumilast Salmeterol COPD Chronic obstructive pulmonary disease
Sponsor: AstraZeneca
Start date: 2006-04-01; Completion date: 2008-02-01
Enrollment: 933 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to compare the efficacy of roflumilast on pulmonary function and symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during concomitant administration of salmeterol. 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: salmeterol 50 μg, twice daily, inhaled arm 2: Placebo

underlying medication: salmeterol 50 μg, twice 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 NCT00326950
Conditions: Cancer
Keywords: Cancer Tumors Phase I E7389
Sponsor: Eisai Co., Ltd.
Start date: 2006-06-01; Completion date: 2008-02-01
Enrollment: 15 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to determine the dose limiting toxicity and maximum tolerated dose of E7389 in patients with solid tumors. The secondary objectives are to investigate the pharmacokinetics, safety, estimated recommended dose, and anti-tumor effects (in evaluable cases) of E7389 in patients with solid tumors.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: E7389
Intervention descriptions: intervention 1: E7389 will be administered intravenously on Days 1 and 8 of a 21 day cycle. The initial dose level will be 0.7 mg/m2, with planned dose levels of 1.0, 1.4, 2.0 mg/m2.

Protocol documents:
Clinical trial NCT00334074
Conditions: Acute Myelogenous Leukemia Myelodysplastic Syndromes Chronic Myelogenous Leukemia
Keywords: AML MDS CML Relapsed Refractory Chemo treatment Clofarabine Cytarabine standard or poor cytogenetic risk AML untreated high-risk (>10% blasts) MDS CML in accelerated phase or blast crisis Elderly AML patients with risk of anthracycline toxicity
Sponsor: Baylor Research Institute
Start date: 2005-08-01; Completion date: 2008-02-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this trial is to to determine the safety and effectiveness of therapeutic combination - Clofarabine and Cytarabine for the treatment of AML and MDS.

Detailed description:
Previous studies of Clofarabine and Cytarabine combination treatment in adult AML and MDS patients showed promising results.

This study is done to confirm the findings from previous studies. Primary objective is to determine the overall response rate (complete response \[CR\] plus partial response \[PR\]); secondary objective of this study is to characterize and quantify the toxicity profile associated with clofarabine plus cytarabine treatment.

A maximum of 35 patients will be treated on this study. They will receive 5 consecutive days of clofarabine intra venous infusion (IVI) followed 4 hours later by cytarabine IVI.Patients will receive up to a maximum of 4 cycles of study treatment. Next cycle will start approximately 4 weeks after Day 1 of previous cycle.No other investigational or commercial agents including chemotherapy, radiotherapy, or immunotherapy may be administered to patients enrolled in this study with the intention of treating the underlying malignancy

Patients will remain on study, and be monitored until 4 months have elapsed from the beginning date of their last cycle of treatment.

Arms: arm 1: Five consecutive days of clofarabine 40 mg/m\^2 IVI over 1 hour followed 4 hours later by cytarabine 1000 mg/m\^2 IVI over 2 hours
Interventions: intervention 1: Clofarabine and Cytarabine
Intervention descriptions: intervention 1: Phase II Trial of Clofarabine and Cytarabine in Relapsed Standard-Risk AML and Untreated High-Risk MDS in Adult Patients, and Untreated AML in selected Elderly Patients at high risk of anthracycline toxicity

Protocol documents:
Clinical trial NCT00336479
Conditions: Chronic Hepatitis C
Sponsor: Vertex Pharmaceuticals Incorporated
Start date: 2006-06-01; Completion date: 2008-02-01
Enrollment: 263 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) and Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels

Detailed description:

Arms: arm 1: Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 48 weeks. arm 2: Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks. arm 3: Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. arm 4: Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 12 weeks.
Interventions: intervention 1: Telaprevir intervention 2: Ribavirin intervention 3: Pegylated Interferon Alfa 2a intervention 4: Placebo
Intervention descriptions: intervention 1: tablet intervention 2: tablet intervention 3: Solution for injection intervention 4: matching placebo tablet

Protocol documents:
Clinical trial NCT00350519
Conditions: Hemostasis, Surgical
Keywords: Hemostasis, Surgical Epoetin alfa Surgery Abdomen Pelvis PROCRIT pRBC Blood transfusion Packed red blood cell transfusion
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Start date: 2006-08-01; Completion date: 2008-02-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of the study is to compare the effect of perioperative (the time period describing the duration of a participants surgical procedure) administration of PROCRIT to that of Standard of Care (SOC) on the proportion of participants receiving pRBC (packed red blood cells) transfusions (from the day of surgery to the day of hospital discharge) in participants undergoing elective major abdominal and/or pelvic surgery. Standard of Care is defined as the treatment of participants according to the hospital or institution's policy, but where participants will not receive PROCRIT (Epoetin alfa) or any other erythropoiesis-stimulating agents (ESAs) (agents that stimulate the production of red blood cells in the bone marrow).

Detailed description:
This is a randomized (the study medication is assigned by chance), parallel-arm (each group of participants will be treated at the same time), open-label (all people know the identity of the intervention), multicenter study. The study consists of screening phase of 21 days, treatment phase of 15 days, follow-up phase of 28 days. Approximately 110 participants undergoing elective major abdominal and/or pelvic surgery will be enrolled. During the Treatment Phase, eligible participants will be randomly assigned (participants are assigned to a treatment group based on chance) in a 1:1 ratio to either PROCRIT (Epoetin alfa) or the Standard of Care (SOC) group that will not receive any erythropoiesis-stimulating agents (ESAs). Participants will undergo surgery during the Treatment Phase. After surgery, all participants will stay in the study for 4 days (or until hospital discharge) and followed for an additional 28 days (Follow-up Phase). Safety evaluations will include assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination which will be monitored throughout the study. The duration of the study for each participant will be approximately 64 days.

Arms: arm 1: Participants will receive PROCRIT (epoetin alfa). arm 2: Participants will receive standard of care.
Interventions: intervention 1: Epoetin alfa intervention 2: Standard of Care
Intervention descriptions: intervention 1: Participants will receive epoetin alfa 300 IU/kg once daily subcutaneously for 10 days prior to surgery, on the day of surgery, and for four days after surgery. intervention 2: Participants will receive standard of care based on the Institution's treatment policy.

Protocol documents:
Clinical trial NCT00362817
Conditions: Brain Tumor Brain Metastases
Keywords: Recurrent Symptomatic
Sponsor: Ohio State University Comprehensive Cancer Center
Start date: 2004-10-01; Completion date: 2008-02-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Purpose: The primary objective of this study is to determine if chemotherapy with carboplatin and temozolomide significantly affects the response rates, or size of disease, in patients with brain metastases, originating from cancer in other parts of the body, compared to patients who have already been treated with radiation. Survival, causes of death, recurrence of disease in the central nervous system, toxicity, and quality of life will all be measured as secondary objective in this study.

Detailed description:
Rationale: Surgery and radiation are often used as treatments for brain metastases, or tumors in the brain that originate from other parts of the body. It is currently unknown whether patient survival or time to progression would experience additional benefits through the addition of chemotherapy. Previous research does appear to suggest that a chemotherapy regimen may improve outcomes of patients with brain metastases previously treated with radiation. The current study further evaluates this research question by providing patients with recurrent or symptomatic residual brain metastases with carboplatin and temozolomide, two chemotherapy agents. Temozolomide has demonstrated clinical antitumor efficacy against malignant gliomas and has been tested with some efficacy against several other types of cancer. This drug appears to have less adverse effects compared to other commonly used cancer drugs. Recent research indicates that temozolomide also has some efficacy against brain metastases. In addition, previous research indicates carboplatin's lack of severe toxicity in patients with this disease.

Treatment: Study participants will be treated with carboplatin and temozolomide. Carboplatin will be administered through intravenous infusions. Temozolomide will be given through oral pills. Before these drugs are administered, study participants will undergo a pre-treatment evaluation with physical and neuropsychological examinations, neuro-imaging, laboratory tests, quality of life assessment, and other procedures. Carboplatin will be given for two consecutive days. Temozolomide will be taken by study participants daily for five consecutive days. Both of these treatment schedules will be repeated every 28 days. Several tests and exams will be given throughout the study to closely monitor patients. Study treatments will be discontinued due to disease growth or unacceptable adverse events.

Arms: arm 1: Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin
Interventions: intervention 1: carboplatin intervention 2: temozolomide
Intervention descriptions: intervention 1: IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2. intervention 2: 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.

Protocol documents:
Clinical trial NCT00368277
Conditions: Hypertension
Keywords: Systolic hypertension hypertension aliskiren blood pressure ramipril HTN
Sponsor: Novartis Pharmaceuticals
Start date: 2006-09-01; Completion date: 2008-02-01
Enrollment: 901 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluate the systolic blood pressure lowering effect of aliskiren 150mg and 300mg compared to ramipril 5mg and 10mg in elderly patients with essential systolic hypertension.

Detailed description:

Arms: arm 1: Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg arm 2: Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
Interventions: intervention 1: Aliskiren intervention 2: Ramipril intervention 3: Hydrochlorothiazide intervention 4: Amlodipine
Intervention descriptions: intervention 1: Aliskiren 150 mg and 300 mg tablets taken orally, once a day in the morning intervention 2: Ramipril 5 mg and 10 mg capsules taken orally, once a day in the morning intervention 3: Hydrochlorothiazide 12.5 or 25 mg capsules taken orally, once a day in the morning intervention 4: Amlodipine 5 mg or 10 mg tablets taken orally, once a day in the morning

Protocol documents:
Clinical trial NCT00373334
Conditions: Gastroesophageal Reflux Disease GERD Heartburn
Keywords: gastroesophageal reflux disease GERD heartburn
Sponsor: Braintree Laboratories
Start date: 2006-08-01; Completion date: 2008-02-01
Enrollment: 138 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the efficacy, acceptability, and safety of Axid Oral Solution versus placebo in the treatment of gastroesophageal reflux disease (GERD) in infants age 30 days up to 1 year.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: nizatidine (axid) intervention 2: nizatidine (axid) intervention 3: placebo
Intervention descriptions: intervention 1: nizatidine (axid) intervention 2: nizatidine (axid) intervention 3: placebo

Protocol documents: