ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00332696
Conditions: Peritoneal Neoplasms Intestinal Obstruction Carcinomatosis
Keywords: bowel obstruction, peritoneal carcinomatosis Octreotide inoperable
Sponsor: Novartis Pharmaceuticals
Start date: 2005-09-01; Completion date: 2008-09-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate in combination with corticosteroid and local standard medical care the efficacy and safety of long-acting octreotide compared to placebo for the treatment of symptoms of inoperable bowel obstruction in patients with peritoneal carcinomatosis

Detailed description:

Arms: arm 1: Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days. arm 2: Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
Interventions: intervention 1: Octreotide LAR intervention 2: Octreotide (Immediate release) intervention 3: methylprednisolone intervention 4: Placebo
Intervention descriptions: intervention 1: Octreotide long-acting release (LAR) 30 mg intramuscular injection. intervention 2: Immediate-release Octreotide supplied in 100 µg/mL ampules. intervention 3: methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections). intervention 4: Physiologic saline solution

Protocol documents:
Clinical trial NCT00339144
Conditions: Tumors
Keywords: Solid tumors (including relapsed disease) that are refractory to standard therapies or for which no effective standard therapy exists
Sponsor: Bristol-Myers Squibb
Start date: 2007-01-01; Completion date: 2008-09-01
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to determine the maximum tolerated dose (MTD) or the maximum administered dose (MAD) of Dasatinib (BMS-354825) in patients in Japan.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Dasatinib intervention 2: Dasatinib intervention 3: Dasatinib
Intervention descriptions: intervention 1: tablets, Oral, 100 mg, once daily for 4 weeks intervention 2: tablets, Oral, 150 mg, once daily, 4 weeks intervention 3: tablets, Oral, 200 mg, once daily for 4 weeks

Protocol documents:
Clinical trial NCT00350207
Conditions: Asthma
Sponsor: Boehringer Ingelheim
Start date: 2006-07-01; Completion date: 2008-09-01
Enrollment: 388 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy, placebo-controlled, parallel group study to evaluate the long-term efficacy and safety of tiotropium compared to salmeterol in moderate persistent asthmatic (GINA step 3) patients homozygous for arginine at the 16th amino acid position of the beta-adrenergic receptor (ADRB2). Following an initial 4-week run-in period on salmeterol MDI patients will be randomised into the 16 week double-blind treatment period in which they receive either tiotropium once daily administered from the Respimat inhaler or salmeterol twice daily administered from the hydrofluoro-alkane Metered Dose Inhaler (MDI), or placebo twice daily. After the 16 week treatment period all patients will receive salmeterol MDI twice daily for four weeks.

The patients perform daily morning and evening peak flow (PEF) and Forced Expiratory Volume in the First Second (FEV1) measurements with an electronic peak flow meter throughout the study. Daily data on asthma control and use of rescue medication are recorded using an electronic diary included in the electronic peak flow meter. On study visits the Mini-Asthma Quality of Life Questionnaire (Elizabeth Juniper) is administered, pulse and blood pressure and pre-dose pulmonary function testing (FEV1 and Forced Vital Capacity) are performed.

Detailed description:

Interventions: intervention 1: Tiotropium bromide intervention 2: Placebo intervention 3: Salmeterol xinafoate
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00351039
Conditions: Non-Small Cell Lung Cancer
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2006-07-01; Completion date: 2008-09-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase I/II trial of elderly patients (\> 70 years of age). Patients in this age group with previously un-treated Advanced Stage Non-Squamous Non-Small Cell Lung Cancer (NSCLC) with Stage IIIB (with malignant pleural effusion) and stage IV disease will be enrolled. Therapy consists of three drugs (Premetrexed\[Alimta™\], Bevacizumab and Erlotinib\[Tarceva™\]) which are given every 28 days.

Detailed description:
This is a Phase I/II trial of elderly patients (\> 70 years of age) with previously un-treated Advanced Stage Non-Squamous NSCLC with Stage IIIB (with malignant pleural effusion) and stage IV disease will be enrolled.

Treatment Regimen:

Premetrexed (Alimta™) 500 milligrams(mg)/Meter squared(m20 Intravenous(I.V.) Day 1 and Day 15; Bevacizumab 10mg/Kilogram(Kg) I. V. Day 1 and Day 15; Erlotinib (Tarceva™) 150mg Per Orally(PO) Once Daily(QD) for 7 days starting day 2 and day 15; Repeat cycles every 28 days.

All three drugs will be continued for two cycles after maximal response. After which patient will be maintained only on the Bevacizumab and Erlotinib until progression. If patient has stable disease after the first two cycles then patient will be given another two cycles with all three drugs before maintenance treatment with Bevacizumab and Erlotinib is initiated.

Arms: arm 1: Single Arm Phase II trial in elderly patients with advanced stage Non-Squamous Non-Small Cell Lung Cancer
Interventions: intervention 1: Bevacizumab intervention 2: Erlotinib intervention 3: Pemetrexed
Intervention descriptions: intervention 1: Treatment Regimen Item 1: Bevacizumab 10 mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. intervention 2: Treatment Regimen Item 2: Erlotinib 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days. intervention 3: Treatment Regimen Item 3: Premetrexed 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days.

Protocol documents:
Clinical trial NCT00351273
Conditions: Arthritis, Reactive Reiter Disease
Keywords: Chlamydia
Sponsor: University of South Florida
Start date: 2006-05-01; Completion date: 2008-09-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Reactive arthritis, also known as Reiter's syndrome, is a form of arthritis that occurs as a reaction to an infection elsewhere in the body. It is characterized by inflammation of the joints, tendons, urogenital tract, and eyes. Pain and swelling in the knees, ankles, and feet are common. This study will determine the effectiveness of antibiotic therapy in treating people with chlamydia-induced reactive arthritis that has lasted for more than 6 months.

Detailed description:
The initial infection that causes reactive arthritis is caused by one of two bacteria: Chlamydia trachomatis, which is usually acquired through sexual contact, or Chlamydia pneumoniae, which can cause respiratory infections. Most people recover fully from the initial flare of arthritis symptoms. However, about 20% of people with reactive arthritis experience long-lasting symptoms. In these individuals, the Chlamydia bacteria exist in a persistent metabolically active state within the joint tissue, even years after the initial exposure. The bacteria produce heat shock proteins (HSPs), which are thought to play a key role in the chronic persistent state of Chlamydia and which may stimulate the immune inflammatory response seen in reactive arthritis. This indicates the need for antimicrobial therapy that can reduce Chlamydia's HSP production and block its metabolism. The purpose of this study is to determine the effectiveness of long-term combination antibiotic therapy in treating people with chronic reactive arthritis. The study will use two different combinations of common antibiotics: doxycycline paired with rifampin and azithromycin paired with rifampin.

This study will entail 6 months of treatment followed by 3 months of follow-up. After screening, eligible participants will be randomly assigned to one of three treatment groups: rifampin once a day plus doxycycline twice a day; rifampin once a day plus azithromycin once a day for 5 days, then twice weekly; or placebo. Study visits will occur at baseline and Months 1, 3, 6, and 9. At all visits, participants will undergo an interview, a physical examination, and blood collection. They will also complete a questionnaire related to their symptoms and functional status. At screening and Month 6, a synovial biopsy may be performed. This will involve taking a sample of the tissue that lines the joints.

Arms: arm 1: Participants received Azithromycin and Rifampin arm 2: Participants received Doxycycline and Rifampin arm 3: Participants received placebo
Interventions: intervention 1: Doxycycline and Rifampin intervention 2: Azithromycin and Rifampin intervention 3: Placebo
Intervention descriptions: intervention 1: doxycycline 100mg daily; rifampin 300mg daily (both for 6 months) intervention 2: Azithromycin 500mg daily for 5 days and then twice weekly; Rifampin 300mg daily (both for 6 months) intervention 3: Methylcellulose

Protocol documents:
Clinical trial NCT00354770
Conditions: Trichotillomania
Keywords: Trichotillomania Hair-pulling
Sponsor: University of Chicago
Start date: 2006-07-01; Completion date: 2008-09-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 12-week, double-blind study of N-Acetyl Cysteine in the treatment of trichotillomania

Detailed description:
The goal of the proposed study is to evaluate the efficacy and safety of N-Acetyl Cysteine (NAC) in trichotillomania. Forty subjects with DSM-IV trichotillomania will receive 12 weeks of double-blind NAC or placebo. The hypothesis to be tested is that NAC will be effective and well tolerated in patients with trichotillomania compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Arms: arm 1: N-Acetyl Cysteine arm 2: Placebo
Interventions: intervention 1: Placebo intervention 2: N-Acetyl Cysteine
Intervention descriptions: intervention 1: daily intervention 2: 600mg capsules in varying doses for 12 weeks.

Protocol documents:
Clinical trial NCT00359294
Conditions: Solid Tumors Lymphoma
Keywords: Tumor Lymphoma Zalypsis PharmaMar PM00104
Sponsor: PharmaMar
Start date: 2006-05-01; Completion date: 2008-09-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Phase I trial, dose escalating, prospective, open-label, non-randomized, multicenter study. The purpose is to determine the safety, tolerability, dose limiting toxicity (DLT) and recommended dose (RD) of PM00104, administered intravenously over 1 hour daily for 5 days every 3 weeks (this is considered as 1 cycle) to subjects with advanced malignant solid tumors or lymphoma.

Detailed description:
Phase I trial, dose escalating, prospective, open-label, non-randomized, multicenter study. The purpose is to determine the safety, tolerability, dose limiting toxicity (DLT) and recommended dose (RD) of PM00104, administered intravenously over 1 hour daily for 5 days every 3 weeks (this is considered as 1 cycle) to subjects with advanced malignant solid tumors or lymphoma. Secondary objectives are to determine the preliminary pharmacokinetics of PM00104, to evaluate the relationship between pharmacokinetics/pharmacodynamics and to evaluate the preliminary antitumor activity of PM00104. Dose-escalation guidelines will follow an accelerated phase I design for conventional cytotoxic agents in order to minimize the number of subjects treated at the subtoxic dose levels. The trial will be conducted in compliance with the protocol, Good clinical practice (GCP) and applicable regulatory requirements.

Arms: arm 1: None
Interventions: intervention 1: PM00104
Intervention descriptions: intervention 1: Intravenously over 1 hour daily for 5 days, every 3 weeks.

Protocol documents:
Clinical trial NCT00359944
Conditions: Alzheimer's Disease
Keywords: Alzheimer Dementia
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2006-02-01; Completion date: 2008-09-01
Enrollment: 171 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate efficacy and safety of different doses of AC-3933 in patients with mild to moderate Alzheimer's Disease.

Detailed description:

Arms: arm 1: AC-3933, 5mg twice daily arm 2: AC-3933, 20 mg twice daily arm 3: Sugar Pill twice daily
Interventions: intervention 1: AC-3933 intervention 2: AC-3933 intervention 3: Sugar Pill
Intervention descriptions: intervention 1: 5mg twice daily intervention 2: AC-3933, 20 mg twice daily intervention 3: Sugar Pill twice daily

Protocol documents:
Clinical trial NCT00361439
Conditions: Seasonal Allergic Rhinitis
Sponsor: University of Chicago
Start date: 2006-08-01; Completion date: 2008-09-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
People with allergies frequently complain of a loss or reduction in the sense of smell.

In this study, the investigators propose to perform a randomized, double blind, placebo controlled parallel study of subjects with nasal allergies and decreased smell to determine the effect of a treatment for allergies on the sense of smell.

Detailed description:

Arms: arm 1: Mometasone intranasal steroid therapy daily for 2 weeks arm 2: 2 puffs of placebo spray in each nostril once daily
Interventions: intervention 1: Mometasone intervention 2: Placebo
Intervention descriptions: intervention 1: 2 puffs in each nostril once daily of nasal spray intervention 2: 2 puffs in each nostril once daily of nasal spray

Protocol documents:
Clinical trial NCT00370071
Conditions: Multiple Sclerosis
Keywords: MS
Sponsor: Bayer
Start date: 2006-11-01; Completion date: 2008-09-01
Enrollment: 39 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if the study drug is effective and safe in the treatment of Multiple Sclerosis (MS) in patients of Chinese origin.

Detailed description:
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany.

Bayer HealthCare AG, Germany is the sponsor of the trial.

Arms: arm 1: Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
Interventions: intervention 1: Interferon beta-1b (Betaseron, BAY86-5046)
Intervention descriptions: intervention 1: Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)

Protocol documents:
Clinical trial NCT00370292
Conditions: Non Small Cell Lung Cancer
Sponsor: Eli Lilly and Company
Start date: 2006-09-01; Completion date: 2008-09-01
Enrollment: 19 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Patients affected by non-small cell lung cancer (NSCLC) will be treated in pemetrexed monochemotherapy regimen for a maximum of 8 cycles. Pemetrexed is an enhancer of some biomolecules involved in the gemcitabine mechanism of action. Purpose of the trial is to monitor the blood values of these biomolecules at different time intervals, to optimize the synergism between pemetrexed and gemcitabine.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Pemetrexed - Before Protocol Amendment intervention 2: Pemetrexed - After Protocol Amendment
Intervention descriptions: intervention 1: 500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles or disease progression, unacceptable toxicity or patient decision to discontinue intervention 2: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 6 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.

Protocol documents:
Clinical trial NCT00371254
Conditions: Breast Cancer Metastasis
Keywords: Recurrent, locally-advanced, or 'triple negative' metastatic breast cancer
Sponsor: Bristol-Myers Squibb
Start date: 2006-12-01; Completion date: 2008-09-01
Enrollment: 55 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will determine whether the investigational drug dasatinib is effective in treatment of women with progressive advanced triple-negative breast cancer.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Dasatinib intervention 2: Dasatinib
Intervention descriptions: intervention 1: Tablets, Oral, 100 mg, twice daily as long as the patient benefits (avg \<6 months) intervention 2: Tablets, Oral, 70 mg, twice daily as long as the patient benefits (avg \<6 months)

Protocol documents:
Clinical trial NCT00373880
Conditions: Cocaine Abuse
Keywords: Aripiprazole Cocaine abuse
Sponsor: New York State Psychiatric Institute
Start date: 2005-04-01; Completion date: 2008-09-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to investigate whether aripiprazole will decrease cocaine self-administration, subjective effects and cravings compared to placebo.

Detailed description:
Despite the recent increase in data about cocaine's basic neurochemical mechanisms of action, progress towards the development of an effective pharmacological treatment for cocaine abuse has been disappointing. We are proposing to use our laboratory model of repeated dose cocaine self-administration to assess the potential efficacy of the novel antipsychotic, aripiprazole. Aripiprazole is a partial agonist at both the dopamine D2 receptor and at the serotonin 5HT1a receptor, while antagonizing the 5HT2a receptor. By functioning as a partial D2 agonist, aripiprazole is hypothesized to function as a D2 antagonist during hypodopaminergic states, such as during cocaine use, while functioning as a D2 agonist during hypodopaminergic states, such as during cocaine withdrawal. This 42-day, outpatient/inpatient/outpatient/inpatient protocol will evaluate the effects of aripiprazole maintenance (0, 15 mg/day) on cocaine craving, subjective effects, and self-administration using a within-subjects design. Non-treatment seeking cocaine abusers will be maintained outpatient for 16 days of dose maintenance prior to inpatient cocaine self-administration sessions. During the inpatient phases, volunteers will live on a hospital clinical research unit and will participate in laboratory sessions in which they will have the opportunity to choose between repeated doses of smoked cocaine and $5. In addition to measuring their cocaine self-administration, we will measure the cardiovascular and subjective effects of cocaine under each aripiprazole maintenance condition.

Arms: arm 1: Aripiprazole (15 mg/day) in conjunction with a smoked cocaine dose-response curve (0, 12, 25, 50 mg). arm 2: Placebo (0 mg/day) in conjunction with a smoked cocaine dose-response curve (0, 12, 25, 50 mg)
Interventions: intervention 1: Aripiprazole + Cocaine intervention 2: Placebo + Cocaine
Intervention descriptions: intervention 1: Participants received aripiprazole (15mg/day) in conjunction with a dose-response of cocaine (0, 12, 25, 50 mg). intervention 2: Placebo (0 mg/day) in conjunction with a dose-response of cocaine (0, 12, 25, 50 mg).

Protocol documents:
Clinical trial NCT00376935
Conditions: HIV Infections
Keywords: Treatment Experienced
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Start date: 2006-12-01; Completion date: 2008-09-01
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Palifermin is a modified version of a naturally occurring human growth factor that is currently approved by the FDA to treat blood cancers. The purpose of this study is to determine whether palifermin can increase CD4 counts in treatment-experienced HIV infected adults.

Detailed description:
Antiretroviral therapy (ART) has dramatically improved the clinical outcome for HIV infected adults; however, some people on potent ART experience poor recovery of CD4 counts despite maximum suppression of viral load. Such uncontrolled HIV infection is associated with the reduced ability by the human body to create new T cells (or thymopoiesis). HIV infected adults experiencing reduced thymopoiesis are at increased risk of clinical disease progression.

The thymus is the primary site for CD4 cell development; research suggests that keratinocyte growth factor (KGF) may enhance thymus activity in individuals who exhibit reduced thymopoiesis. Palifermin is a modified version of the naturally occurring KGF that is approved to treat people with hematologic malignancies. The purpose of this study is to evaluate the safety and efficacy of palifermin in increasing CD4 counts, through enhanced thymopoiesis, in treatment-experienced HIV infected adults with suppressed viral loads but low CD4 counts.

This study will last 24 weeks. Participants will be randomly assigned to one of four arms:

* Arm A participants will receive placebo
* Arm B participants will receive palifermin 20 mcg/kg
* Arm C participants will receive palifermin 40 mcg/kg
* Arm D participants will receive palifermin 60 mcg/kg

Participants will receive intravenous doses of their assigned intervention on Days 1, 2, and 3. All participants must remain on their current ART regimen for the duration of the study. ART will not be provided by the study. There will be six study visits, and they will occur at Weeks 1, 2, 4, 8, 12, and 24. All visits will include a targeted physical exam and blood and urine collection.

Arms: arm 1: Participants will receive palifermin placebo injection on Days 1, 2, and 3 arm 2: Participants will receive palifermin 20 mcg/kg injection on Days 1, 2, and 3 arm 3: Participants will receive palifermin 40 mcg/kg injection on Days 1, 2, and 3 arm 4: Participants will receive palifermin 60 mcg/kg injection on Days 1, 2, and 3
Interventions: intervention 1: Palifermin intervention 2: Palifermin placebo
Intervention descriptions: intervention 1: Keratinocyte growth factor administered via injection intervention 2: Keratinocyte growth factor placebo administered via injection

Protocol documents:
Clinical trial NCT00377520
Conditions: Neoplasms Neoplasms by Site Urogenital Neoplasms Genital Neoplasms, Female Uterine Neoplasms Endometrial Neoplasms Cancer of Endometrium Endometrial Cancer Cancer of the Endometrium Endometrium Cancer Neoplasms, Endometrial
Sponsor: Eli Lilly and Company
Start date: 2006-09-01; Completion date: 2008-09-01
Enrollment: 27 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The intent of this protocol is to screen a new agent for activity in patients with advanced or recurrent endometrial carcinoma. This phase II trial is studying how well pemetrexed disodium works in treating patients with advanced or recurrent endometrial carcinoma.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: pemetrexed
Intervention descriptions: intervention 1: 900 mg/m2, intravenous (IV), every 21 days, until disease progression

Protocol documents: