ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00657917
Conditions: Cutaneous Leishmaniasis
Keywords: leishmaniasis cutaneous Old World Leishmania major Treatment
Sponsor: U.S. Army Medical Research and Development Command
Start date: 2006-12-20; Completion date: 2010-06-24
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this protocol is to treat laboratory confirmed cutaneous leishmaniasis with WR 279,396 in military health care beneficiaries. In this study "cutaneous leishmaniasis" is defined as Old World Leishmaniasis if acquired in the Southwest Central Asia/Middle East.

Detailed description:
Up to 10 volunteers, who are military health care beneficiaries, with a diagnosis of Old World cutaneous leishmaniasis who have failed pentavalent antimony or are not eligible to be treated with pentavalent antimony, will be treated with WR 279,396 (topical paromomycin-gentamicin-AQIC) twice a day for 20 days. Primary endpoint will be the appearance of complete epithelialization of each skin lesion by Day 50+/-2 weeks, or estimated 50%-99% re-epithelialization by Day 50+/-2 weeks followed by complete epithelialization by Day 100+/-2 weeks,with both categories without relapse by Day 180+/-30 days. Efficacy will be evaluated by clinical appearance assessed by study investigator and documented with photographs of the treated skin lesions. Toxicity will be evaluated by local adverse reactions and by laboratory signs of systemic toxicity.

Arms: arm 1: WR279,396 topically twice a day for 20 days
Interventions: intervention 1: Paromomycin +Gentamicin topical cream
Intervention descriptions: intervention 1: WR297,396 for treatment of patients with parasitologically confirmed, primarily ulcerative, Old World CL, who had either failed pentavalent antimony treatment, or who where ineligible for pentavalent antimony therapy.

Protocol documents:
Clinical trial NCT00760929
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2008-11-10; Completion date: 2010-06-25
Enrollment: 171 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 4 arm study in patients with advanced Stage IIIb/IV non-small cell cancer (NSCLC) who failed at least one standard chemotherapy regimen will determine the proportion of patients with progression-free survival at 12 weeks following combination therapy with R1507 and Tarceva or placebo and Tarceva. Patients will be randomized to one of four treatment arms to receive R1507 (9mg/kg iv) or placebo weekly or R1507 (16mg/kg iv) or placebo every 3 weeks. Tarceva (150mg oral daily) will be administered in all treatment arms. Other disease-related endpoints including overall survival, objective response rate, time to response, time to progressive disease and duration of response will also be evaluated. The anticipated time on study treatment is 1-2 years, and the target sample size is \<500 individuals.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Placebo intervention 2: Placebo intervention 3: RG1507 intervention 4: RG1507 intervention 5: erlotinib [Tarceva]
Intervention descriptions: intervention 1: iv 9mg/kg weekly intervention 2: iv 16mg/kg every 3 weeks intervention 3: iv 9mg/kg weekly intervention 4: iv 16mg/kg every 3 weeks intervention 5: 150mg oral daily

Protocol documents:
Clinical trial NCT00996944
Conditions: Restless Legs Syndrome
Keywords: ropinirole haemodialysis restless legs syndrome
Sponsor: GlaxoSmithKline
Start date: 2009-11-30; Completion date: 2010-06-29
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, placebo controlled, parallel group, double-blind, randomized comparison study to evaluate the efficacy and safety of ropinirole IR tablets orally administered for 12 weeks in patients with symptomatic restless legs syndrome associated with Chronic kidney disease (CKD) managed with haemodialysis (including haemofiltration and haemodiafiltration) (hereinafter referred to as "uRLS"), to evaluate the efficacy and safety of long-term administration of ropinirole IR tablets, and assess the effect on the steady state pharmacokinetics in the long-term administration period of ropinirole IR tablets.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ropinirole immediate release (IR) intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects completing the screening period will be randomized (1:1) to receive the IR or placebo for 12 weeks. The treatment will be started at the initial dose of 0.25 mg/day within 1 to 3 hours before bedtime. The maximum available dose is 3 mg/day. For all subjects completing short-term period and entering the long-term treatment period, the open-label treatment will be started from IR 0.25 mg/ day regardless of dose levels during short-term period. The dose will be upward titrated from 0.25 mg/day to 0.5 mg/day and after that in increments of 0.5 mg/day until sufficient efficacy is obtained (targeting "much improved" or "very much improved" in the CGI-I) without safety/tolerability problem. intervention 2: Subjects completing the screening period will be randomized (1:1) to receive the IR or placebo for 12 weeks. The treatment will be started at the initial dose of 0.25 mg/day within 1 to 3 hours before bedtime.

Protocol documents:
Clinical trial NCT00638963
Conditions: Breast Neoplasm Brain Neoplasm Second Neoplasm
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-10-02; Completion date: 2010-06-30
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether temozolomide can be used as a prophylaxis against brain recurrence in participants with metastatic breast cancer.

Detailed description:
Breast cancer is the second most common cause of brain metastases. Overall survival after the development of brain metastases tends to be poor (6-8 months). Over-expression of Human Epidermal Growth Factor Receptor 2 (HER-2/neu), negative estrogen receptor, and young age at diagnosis seem to be indicators of high risk for brain metastases. Temozolomide may be a good candidate for prophylactic chemotherapy because of its ability to cross the blood-brain-barrier, achieving high concentrations in the central nervous system (CNS).

Arms: arm 1: None arm 2: None
Interventions: intervention 1: temozolomide
Intervention descriptions: intervention 1: Capsules to equal 75 mg/m\^2, orally, daily for 6 weeks, in 3 eight-week cycles

Protocol documents:
Clinical trial NCT00100048
Conditions: HIV Infections Acquired Immunodeficiency Syndrome
Sponsor: Merck Sharp & Dohme LLC
Start date: 2005-01-01; Completion date: 2010-07-01
Enrollment: 206 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study that will investigate the safety and efficacy of an investigational drug in Human immunodeficiency virus (HIV) infected patients.

Detailed description:
Participants who completed 48 weeks of the original 48-week double-blind study were invited to continue in two extensions: MK0518-004-10 (NCT00100048), which extended the study to 144 weeks, and MK0518-004-20 (NCT00100048), which extended the study to 240 weeks. Participants who had been randomized to MK0518 in the base study continued at 400 mg MK0518 twice daily.

Participants randomized to efavirenz in the base study continued to receive efavirenz at the dosage given in the base study. The doses of open label tenofovir and lamivudine continued unchanged.

Arms: arm 1: MK0518 600 mg twice daily arm 2: MK0518 400 mg twice daily arm 3: MK0518 200 mg twice daily arm 4: MK0518 100 mg twice daily arm 5: Placebo to MK0518 twice daily arm 6: MK0518 600 mg + tenofovir + lamivudine arm 7: MK0518 400 mg + tenofovir + lamivudine arm 8: MK0518 200 mg + tenofovir + lamivudine arm 9: MK0518 100 mg + tenofovir + lamivudine arm 10: efavirenz + tenofovir + lamivudine
Interventions: intervention 1: Comparator: MK0518 monotherapy intervention 2: Comparator: MK0518 combination therapy intervention 3: Comparator: efavirenz intervention 4: Comparator: tenofovir intervention 5: Comparator: lamivudine intervention 6: Placebo monotherapy
Intervention descriptions: intervention 1: MK0518 twice daily for 10 days intervention 2: MK0518 twice daily for 48 weeks intervention 3: efavirenz 600 mg every night at bedtime for 48 weeks intervention 4: tenofovir 300 mg daily for 48 weeks intervention 5: lamivudine 300 mg daily for 48 weeks intervention 6: Placebo to MK0518 twice daily

Protocol documents:
Clinical trial NCT00134563
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis Relapsing Remitting Secondary Progressive Progressive Relapsing
Sponsor: Sanofi
Start date: 2004-09-01; Completion date: 2010-07-01
Enrollment: 1088 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective was to determine the effect of teriflunomide on the frequency of relapses in patients with relapsing multiple sclerosis (MS).

Secondary objectives were:

* to evaluate the effect of teriflunomide on the accumulation of disability as measured by Expanded Disability Status Scale \[EDSS\], the burden of disease as measured by Magnetic Resonance Imaging \[MRI\] and patient-reported fatigue;
* to evaluate the safety and tolerability of teriflunomide.

Detailed description:
The study period per participant was approximatively 128 weeks broken down as follows:

* Screening period up to 4 weeks,
* 108-week double-blind treatment period (approximatively 2 years)\*,
* 16-week post-treatment elimination follow-up period.

'\*' Participants successfully completing the week 108 visit were offered the opportunity to enter the optional long-term extension study LTS6050 - NCT00803049.

Arms: arm 1: Teriflunomide 7 mg once daily for 108 weeks arm 2: Teriflunomide 14 mg once daily for 108 weeks arm 3: Placebo (for teriflunomide) once daily for 108 weeks
Interventions: intervention 1: Teriflunomide intervention 2: Placebo (for teriflunomide)
Intervention descriptions: intervention 1: Film-coated tablet

Oral administration intervention 2: Film-coated tablet

Oral administration

Protocol documents:
Clinical trial NCT00639002
Conditions: Multiple Myeloma
Sponsor: Incyte Corporation
Start date: 2008-03-01; Completion date: 2010-07-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to determine clinical efficacy and safety of ruxolitinib (INCB018424), a small molecule Janus kinase 2 (JAK2)-inhibitor, in patients with refractory or relapsed multiple myeloma.

Detailed description:
The protocol was originally designed as a Simon two stage but after it was determined that the initial 13 patients enrolled did not meet the definition of a 'responder' according to the International Uniform Response Criteria for multiple myeloma the protocol was amended to allow patients who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or had withdrawn consent to have 40 mg of dexamethasone added to their dose of ruxolitinib.

Arms: arm 1: Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days. For those patients who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion, or withdrew consent, then 40 mg of dexamethasone was added to ruxolitinib on Days 1 to 4, 9 to 12, and 17 to 20 of four 28-day cycles. After the 4th cycle, 40 mg of dexamethasone was administered only on Days 1 to 4 of each subsequent cycle. Patients could continue to receive monotherapy or combination therapy indefinitely as long as no withdrawal criterion was met, did not have progressive disease and were receiving some clinical benefit.
Interventions: intervention 1: Ruxolitinib 25 mg intervention 2: Dexamethasone 40 mg
Intervention descriptions: intervention 1: Ruxolitinib was supplied as 5 and 25 mg tablets. intervention 2: Dexamethasone was obtained commercially by Investigators in tablet strengths of 20 or 40 mg.

Protocol documents:
Clinical trial NCT00690378
Conditions: Complicated Urinary Tract Infection
Sponsor: Pfizer
Start date: 2008-11-01; Completion date: 2010-07-01
Enrollment: 137 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the treatment of complicated urinary tract infections as compared to a comparator group.

Detailed description:

Arms: arm 1: NXL/104 ceftazidime arm 2: comparator 4 x daily
Interventions: intervention 1: NXL104/ceftazidime intervention 2: Imipenem/Cilastatin
Intervention descriptions: intervention 1: 125mg/500mg TID intervention 2: 4 x daily

Protocol documents:
Clinical trial NCT00716417
Conditions: Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2008-07-01; Completion date: 2010-07-01
Enrollment: 47 participants; Allocation: NON_RANDOMIZED; Intervention model: 

Brief summary:
Study to determine the maximum tolerated dose of BIBW 2992 when combined with backbone chemotherapies consisting in cisplatin plus paclitaxel or cisplatin plus 5 FU.

The overall safety, the pharmacokinetics and the anti-tumour efficacy will also be assessed.

Detailed description:

Arms: arm 1: daily oral dose of BIBW 2992 combined with 3-weekly infusion of cisplatin-paclitaxel arm 2: daily oral dose of BIBW 2992 combined with 3-weekly infusion of cisplatin-5FU
Interventions: intervention 1: BIBW 2992 intervention 2: BIBW 2992
Intervention descriptions: intervention 1: In each arm, BIBW 2992 dose will be escalated to determine MTD. Starting dose will be 20mg daily followed by 40 mg (with the option of an intermediary dose of 30 mg) then 50mg daily. Dose escalation will stop at 50 mg. No intra patient dose escalation. intervention 2: low to high dose, daily

Protocol documents:
Clinical trial NCT00761189
Conditions: Schizophrenia
Keywords: Paliperidone R076477 Schizophrenia
Sponsor: Janssen Korea, Ltd., Korea
Start date: 2008-02-01; Completion date: 2010-07-01
Enrollment: 491 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy of paliperidone extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

Detailed description:
This is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center), prospective (study following participants forward in time), single arm, and non-comparative study of paliperidone Extended Release(ER) in participants with schizophrenia. The total study duration will be approximately of 104 weeks per participant. The study consists of following parts: Screening (that is, 14 days before study commences on Day 1); acute Treatment phase (single-oral dose of paliperidone for 12 weeks, dose ranging from 3 to 12 milligram); Extension phase 1 (12 weeks) and Maintenance treatment which will be followed by additional Extension phase 2 and long-term maintenance treatment. Efficacy of the participants will primarily be evaluated by Clinical Global Impression-Improvement (CGI-I) scale score. Participants' safety will be monitored throughout the study.

Arms: arm 1: Paliperidone extended-release (ER) tablet will be administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
Interventions: intervention 1: Paliperidone
Intervention descriptions: intervention 1: Paliperidone extended-release (ER) tablet will be administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.

Protocol documents:
Clinical trial NCT00965848
Conditions: Infection Cross Infection Bacterial Infections Pneumonia, Ventilator-Associated Intra-abdominal Infections Urinary Tract Infections
Keywords: Pneumonia, Ventilator-Associated Intra-abdominal Infections Urinary tract Infections Doripenem Doribax
Sponsor: Janssen-Cilag Ltd.,Thailand
Start date: 2009-06-01; Completion date: 2010-07-01
Enrollment: 270 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety and efficacy of doripenem in participants with nosocomial pneumonia (inflammation of the lungs in which the lungs become heavy; pneumonia occurring at least 48 hours after hospital admission), complicated intra-abdominal (in belly) infections and complicated urinary tract infections (bladder infections).

Detailed description:
This is an open-label (all people involved know the identity of the intervention), multi-center (conducted in more than 1 center) study, to evaluate the safety and effectiveness of doripenem in treating Thai participants with nosocomial pneumonia, complicated intra-abdominal and urinary tract infections. The study consists of 4 visits: Visit 1 (Baseline), Visit 2 (End-of-Treatment \[EOT\], up to Day 14), Visit 3 (Phone visit, Test-of-Cure \[TOC\], up to Day 14 after EOT) and Visit 4 (Phone visit, Day 90). Participants will receive 500 milligram (mg) of doripenem as intravenous infusion (directly into the vein) every 8 hours for at least 3 days after clinical response and extended up to 14 days. Efficacy will primarily be evaluated by determination of clinical response. Participants' safety will be monitored throughout the study.

Arms: arm 1: Doripenem will be administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days. arm 2: Doripenem will be administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days. arm 3: Doripenem will be administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days.
Interventions: intervention 1: Doripenem
Intervention descriptions: intervention 1: Doripenem 500 mg will be administered as 1 or 4 hours intravenous infusion, after every 8 hours up to maximum of 14 days.

Protocol documents:
Clinical trial NCT00003702
Conditions: Good Prognosis Metastatic Gestational Trophoblastic Tumor Hydatidiform Mole Non-Metastatic Gestational Trophoblastic Tumor Uterine Corpus Choriocarcinoma
Sponsor: Gynecologic Oncology Group
Start date: 1999-06-01; Completion date: 2010-07-01
Enrollment: 240 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomized phase III trial to compare the effectiveness of methotrexate with that of dactinomycin in treating patients who have gestational trophoblastic neoplasia. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether methotrexate is more effective than dactinomycin in treating patients with gestational trophoblastic neoplasia.

Detailed description:
OBJECTIVES:

I. Compare the efficacy of methotrexate vs dactinomycin, as measured by complete response rate, in patients with low-risk gestational trophoblastic neoplasia.

II. Compare the toxicity of these regimens in these patients. III. Determine whether the definition of persistent gestational trophoblastic neoplasia is accurate (as determined by the likelihood that the beta human chorionic gonadotropin \[HCG\] titer would decline on the day treatment is initiated).

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive methotrexate intramuscularly once weekly in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive dactinomycin IV over 15 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity. All patients continue on treatment until 1 beta human chorionic gonadotropin (HCG) titer is below the institutional normal. Patients then receive 1 additional consolidation treatment.

Patients are followed every 4 weeks for 1 year.

Arms: arm 1: Patients receive methotrexate intramuscularly once weekly in the absence of disease progression or unacceptable toxicity. Patients continue on treatment until 1 beta HCG titer is below the institutional normal. Patients then receive 1 additional consolidation treatment. arm 2: Patients receive dactinomycin IV over 15 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients continue on treatment until 1 beta HCG titer is below the institutional normal. Patients then receive 1 additional consolidation treatment.
Interventions: intervention 1: Dactinomycin intervention 2: Methotrexate
Intervention descriptions: intervention 1: Given IV intervention 2: Given intramuscularly

Protocol documents:
Clinical trial NCT00053365
Conditions: Primary Peritoneal Cavity Cancer Recurrent Ovarian Epithelial Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2003-06-01; Completion date: 2010-07-01
Enrollment: 61 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Phase II trial to study the effectiveness of irofulven in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Detailed description:
OBJECTIVES:

I. Determine the antitumor activity of irofulven in patients with persistent or recurrent platinum-sensitive ovarian epithelial or primary peritoneal cancer.

II. Determine the toxicity of this drug in these patients.

OUTLINE:

Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.

Patients are followed at approximately 30 days, every 3 months for 2 years, and then every 6 months for 3 years.

PROJECTED ACCRUAL: Approximately 22-60 patients will be accrued for this study within at least 6 months.

Arms: arm 1: Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
Interventions: intervention 1: irofulven
Intervention descriptions: intervention 1: Given IV

Protocol documents: