ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02157116
Conditions: Non-small Cell Lung Cancer
Keywords: Dose-Dense Chemotherapy
Sponsor: Duke University
Start date: 2006-05-01; Completion date: 2010-01-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Dose-dense chemotherapy is a chemotherapy treatment plan in which drugs are given with less time between treatments than in standard chemotherapy. The two chemotherapy drugs used in this study, docetaxel and cisplatin, are approved for the treatment of lung cancer when given every 21 days. This study is exploring the response to chemotherapy when these drugs are given every 14 days. In addition, genetic tests will be performed on pre-treatment specimens to identify signatures that may predict chemotherapy sensitivity or resistance.

Detailed description:
All patients will receive induction chemotherapy with cisplatin and docetaxel. Pegfilgrastim will be administered approximately 24 hours following the end of the day 1 chemotherapy infusion. Cycles will be repeated every 2 weeks for 3 cycles. Patients deemed to be resectable will undergo surgical resection followed by postoperative thoracic radiotherapy. Patients deemed inoperable will additionally receive concurrent chemoradiotherapy. Response, using radiographic and/or pathologic means, will identify two cohorts; responders and nonresponders.Gene expression profiling will then be performed on pre-treatment specimens to identify signatures that predict for chemotherapy sensitivity or resistance.

The target enrollment is 45 patients.

Arms: arm 1: Cisplatin 75mg/m2 IV days 1, 15, 29; Docetaxel 75mg/m2 IV days 1, 15, 29; and Pegfilgrastim 6mg SC day 2, 16, 30
Interventions: intervention 1: cisplatin intervention 2: Docetaxel intervention 3: Pegfilgrastim
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02185183
Conditions: Crohn's Disease
Sponsor: Hadassah Medical Organization
Start date: 2008-01-01; Completion date: 2010-01-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Oral administration of Alequel, a mixture of proteins derived from the patient's bowel will be tested in patients with inflammatory bowel disease.

Detailed description:
Oral administration of Alequel prepared from patients biopsies will be tested in patients with inflammatory bowel disease to determine its anti inflammatory effect.

Arms: arm 1: AlequelTM
Interventions: intervention 1: Alequel
Intervention descriptions: intervention 1: Alequel

Protocol documents:
Clinical trial NCT00601198
Conditions: Colorectal Cancer
Keywords: Oxaliplatin-induced Neuropathy Colon and rectum
Sponsor: University of Cincinnati
Start date: 2006-10-01; Completion date: 2010-01-13
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the effect of amifostine (ETHYOL) on decreasing the rate and severity of nerve dysfunction or neuropathy (numbness and tingling in hands and feet) associated with FOLFOX chemotherapy.

Detailed description:
In addition, this study will provide information on how subjects with colorectal cancer do while receiving amifostine in combination with other chemotherapy drugs. This study will also look at the frequency of complications associated with amifostine and chemotherapy.

The FOLFOX chemotherapy regimen consists of three drugs, 5-FU, leucovorin, and oxaliplatin, all given intravenously (into the vein) every 2 weeks with or without Avastin given in combination with chemotherapy. FOLFOX has been approved by the Food and Drug Administration (FDA) for the treatment of cancer of the colon or rectum.

Amifostine is not a chemotherapy drug. It is approved by the Food and Drug Administration (FDA) to prevent moderate or severe dryness of the mouth caused by radiation treatment for head and neck cancer, and to prevent kidney damage caused by cisplatin chemotherapy treatment for ovarian and non-small cell lung cancer. Amifostine is not FDA approved for use in this study and is therefore considered investigational.

Arms: arm 1: The chemotherapy regimen will be given for 2 consecutive days. On day #1, pt. will be premedicated with drugs to prevent nausea and vomiting in addition to intravenous fluids. Then they will receive amifostine intravenously followed by oxaliplatin, 5FU and leucovorin. This will be followed by an infusion of 5FU given in a pump over 22 hours. If the doctor decides on giving the pt. Avastin, this will be given on day #1. On day #2, they will receive the same treatment except for oxaliplatin.
Interventions: intervention 1: Amifostine
Intervention descriptions: intervention 1: Patients should be treated with oxaliplatin-based chemotherapy in combination with amifostine for 12 cycles, or until unacceptable toxicity is observed or disease progression

Protocol documents:
Clinical trial NCT00613171
Conditions: Systemic Sclerosis, Scleroderma
Keywords: Systemic sclerosis, scleroderma, fibrosis, STI571, imatinib
Sponsor: Novartis Pharmaceuticals
Start date: 2008-01-02; Completion date: 2010-01-13
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study investigates the efficacy and safety of STI571 for the treatment of fibrosis in participants with systemic sclerosis. Other purposes of the study were to investigate whether STI571 is effective in improving lung functions and other test results called biomarkers. Whether STI571 is well-absorbed in systemic sclerosis participants' gut was also investigated by testing the drug level in the blood (pharmacokinetics).

Detailed description:

Arms: arm 1: Participants received ST1571 100 mg tablets, orally, once daily. Initiated at an oral dose of 200 mg/day for 4 weeks then titrated up to 400 mg/day for 2 weeks followed by 600 mg/day until Week 24, if well tolerated.
Interventions: intervention 1: STI571
Intervention descriptions: intervention 1: STI571 tablets taken orally once a day

Protocol documents:
Clinical trial NCT00541450
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-01-15; Completion date: 2010-01-16
Enrollment: 492 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of sitagliptin and MK0431A in comparison to a commonly used medication in patients with type 2 diabetes.

Detailed description:

Arms: arm 1: In Phase A (Treatment Day 1 to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to 15 mg pioglitazone q.d. for 6 weeks followed by matching placebo to 30 mg pioglitazone for the next 6 weeks.

In Phase B (Treatment Week 12-Week 40), participants were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks; as well as matching placebo to 45 mg pioglitazone. arm 2: In Phase A (Treatment Day 1 up to Week 12), randomized participants in the pioglitazone group were administered 15 mg q.d. of pioglitazone and matching placebo to sitagliptin. At Week 6, participants were up-titrated to 30 mg pioglitazone q.d.

In Phase B (Treatment Week 12 to Week 40), participants were administered 45 mg pioglitazone q.d.; as well as matching placebo to Sita/Met FDC (50/500 increased to 50/1000 b.i.d. after 4 weeks).
Interventions: intervention 1: Comparator: sitagliptin phosphate (sitagliptin) intervention 2: sitagliptin phosphate (+) metformin hydrochloride intervention 3: Comparator: pioglitazone intervention 4: Matching placebo to pioglitazone intervention 5: Matching placebo to sitagliptin intervention 6: Matching Placebo to Sita/Met FDC
Intervention descriptions: intervention 1: sitagliptin 100 mg tablet q.d. orally for a 12-wk treatment period intervention 2: sitagliptin/metformin HCl (Sita/Met) 50/500 mg b.i.d. orally and then 50/1000 mg b.i.d. orally for a 28-wk treatment period intervention 3: pioglitazone 15 mg tablet q.d. orally for 6 weeks, followed by 30 mg q.d orally for 6 weeks, followed by 45 mg q.d. orally, up to 40 weeks. intervention 4: matching placebo to pioglitazone tablet q.d. orally, for a 40-wk treatment period.

Participants were administered matching placebo the 15 mg pioglitazone q.d. orally for 6 weeks, followed by matching placebo to 30 mg pioglitazone q.d orally for 6 weeks, followed by matching placebo to 45 mg pioglitazone q.d. orally, up to 40 weeks. intervention 5: matching placebo to sitagliptin q.d., orally for a 12-wk treatment period. intervention 6: matching placebo to Sita/Met FDC - 50/500 mg b.i.d. for 4 weeks and then 50/1000 mg b.i.d. orally for a 28-wk treatment period (Week 12 to Week 40).

Protocol documents:
Clinical trial NCT00461812
Conditions: Asthma
Sponsor: Johns Hopkins University
Start date: 2007-04-01; Completion date: 2010-01-19
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The research hypothesis for the proposed study asks the question, can Asmanex® demonstrate comparable anti-inflammatory therapeutic efficacy to the combination product, Advair® in control of mild persistent asthma?

The purpose is to demonstrate that the anti-inflammatory protection afforded by monotherapy with an inhaled steroid (Asmanex®) is comparable to combination therapy with Advair® 100/50, when measured by this standard methodology (methacholine bronchoprovocation) in subjects with mild persistent asthma.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Mometasone intervention 2: Advair
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01689649
Conditions: Epilepsy
Keywords: Epilepsy Seizures Topiramate Anti-epileptic drug Nervous disorder
Sponsor: Janssen Research & Development, LLC
Start date: 2008-05-02; Completion date: 2010-01-19
Enrollment: 139 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this dose optimization study is to assess tolerability and efficacy of topiramate monotherapy in recently diagnosed patients with epilepsy who are treatment naive or have failed one anti-epileptic drug (AED) treatment in monotherapy.

Detailed description:
This is an open label (all people know the identity of the intervention), dose optimization trial to assess the tolerability and efficacy of topiramate as monotherapy in recently (within 5 years) diagnosed patients with epilepsy. Treatment naive patients (patients who have never received the treatment before) and patients who failed on their first AED in monotherapy are allowed. Failure is defined as a lack of efficacy and/or tolerability of that AED and the reason for failure is recorded by the physician. A lack of efficacy is characterized when the patient has been treated with AED at target dose but the patient still has seizure. Topiramate will first be titrated up to an initial target dose that will be reached after 4-6 weeks. Further dose titration is guided by the clinical response of the individual patient, but the dose may not exceed a maximum of 400mg/day \[9mg/kg/day for children\]. If the patient uses an AED at entry, the AED will be fully tapered off over a period of 3 weeks, starting at the beginning of week 2, in order to have all patients on topiramate monotherapy at visit 3. Tapering the AED off may, however, extend this 3-week period if clinically indicated. Visits will be performed at baseline and after 2, 4, 8, 12, 16 weeks. The total duration for each patient in the study will be 4 months.

Arms: arm 1: For children: Children will start on topiramate with a dosage of 0.5mg/kg in the evening, followed by 0.5mg/kg/day weekly increments until an initial target dose of 3mg/kg/day is reached. The total daily topiramate dose for children may, not exceed 9mg/kg/day. For adult patients: Adult patients start on topiramate with a dosage of 25mg/day in the evening, followed by weekly increments of 25 mg/day until an initial target dose of 100mg/day is reached. The dose of topiramate may be increased to the optimal dose with weekly increments of 0.5mg/kg/day and of 25 mg/day for children and adults, respectively at the discretion of the investigator.
Interventions: intervention 1: Topiramate
Intervention descriptions: intervention 1: The patients will receive topiramate tablet twice daily orally up to 16 weeks.

Protocol documents:
Clinical trial NCT00972322
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-08-24; Completion date: 2010-01-26
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the safety, tolerability, pharmacokinetics, and glucose lowering activity of MK-8245 in participants with type 2 diabetes. The primary hypothesis of the study is that after 4 weeks of treatment, MK-8245 produces a greater reduction in 24 hour weighted mean glucose (WMG) from baseline than placebo.

Detailed description:

Arms: arm 1: MK-8245, 50 mg, twice daily for 28 days arm 2: Placebo to MK-8245, 50 mg, twice daily
Interventions: intervention 1: MK-8245 intervention 2: Comparator: placebo
Intervention descriptions: intervention 1: MK-8245 50 mg twice daily for 28 days intervention 2: matching placebo to MK-8245 twice daily for 28 days

Protocol documents:
Clinical trial NCT01262989
Conditions: Prostatic Hyperplasia
Keywords: Bioequivalence Tamsulosin Healthy volunteers Fast conditions
Sponsor: GlaxoSmithKline
Start date: 2010-01-04; Completion date: 2010-01-26
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
It will be an open-label, randomized, laboratory-blind, crossover study with 02 treatments, 02 sequences, and 02 periods, in which the healthy male volunteers under fasting conditions receive, in each period, the test formulation or the reference formulation

Detailed description:
TITLE: Randomized, two-period, cross-over, bioequivalence study on tamsulosin hydrochloride 0,4 mg prolonged release hard gelatin capsule (Synthon BV, The Netherlands) versus SECOTEX® (tamsulosin hydrochloride) 0,4 mg prolonged release hard gelatin capsule (Boehringer Ingelheim do Brasil Química e Farmacêutica Ltda) in healthy male volunteers under fasting conditions.

It will be an open-label, randomized, laboratory-blind, crossover study with 02 treatments, 02 sequences, and 02 periods, in which the healthy male volunteers under fasting conditions receive, in each period, the test formulation or the reference formulation.

The treatment's sequence attributed to each volunteer on the study period is determined by a randomization list, which is generated by PROC PLAN from SAS version 9.1.3 system.

The formulations will be administered as a single oral dose followed by blood collections between, at least, 3 to 5 half-lives. The treatment's periods may obey a minimum interval of 7 half lives between them (period for drug's whole elimination by the organism).

Arms: arm 1: Reference drug administration followed by Test drug administration arm 2: Test drug administration followed by Reference drug administration
Interventions: intervention 1: Test formulation intervention 2: Reference formulation
Intervention descriptions: intervention 1: tamsulosin hydrochloride 0,4 mg (Synthon BV) intervention 2: tamsulosin 0,4 mg (Boehringer Ingelheim)

Protocol documents:
Clinical trial NCT00171340
Conditions: Bone Loss Breast Cancer
Keywords: Bone Loss Osteopenia Breast cancer letrozole zoledronic acid postmenopausal
Sponsor: Novartis Pharmaceuticals
Start date: 2003-05-01; Completion date: 2010-02-01
Enrollment: 1065 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment of breast cancer and will be randomized to a treatment group to receive either upfront zoledronic acid 4 mg IV 15-minute infusion every 6 months or delayed start zoledronic acid 4 mg IV 15-minute infusion every 6 months. Delayed start zoledronic acid will be initiated when either the Bone Mineral Density T-score is below -2 Standard Deviations at either the lumbar spine or hip or any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the month 36 scheduled visit. Letrozole 2.5 mg will be given daily for 5 years.

Detailed description:

Arms: arm 1: Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1. arm 2: Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score \<= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
Interventions: intervention 1: Zoledronic acid intervention 2: Letrozole
Intervention descriptions: intervention 1: Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months. intervention 2: Letrozole tablets 2.5 mg/day taken orally for 5 years.

Protocol documents:
Clinical trial NCT00396877
Conditions: Heart Defects, Congenital
Keywords: cyanotic congenital heart disease shunt palliation thrombosis clopidogrel
Sponsor: Sanofi
Start date: 2006-11-01; Completion date: 2010-02-01
Enrollment: 906 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Contemporary management of cyanotic congenital heart disease includes three stages of surgery. Incidence of shunt thrombosis and death between the two first stages of palliation remains important.

The primary objective of the study is to evaluate the efficacy of Clopidogrel 0.2 mg/kg/day for the reduction of all cause mortality and shunt related morbidity in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt (e.g. modified Blalock Taussig Shunt \[BTS\]).

The secondary objective was to assess the safety of Clopidogrel in the study population.

Detailed description:
In this event-driven study, participants were to be randomized and treated as soon as possible after shunt placement. They were then to be treated and followed until the primary endpoint criteria was reached i.e. (shunt thrombosis, the next surgical procedure for correction of the congenital heart disease or death) or one year of age or the common study-end-date, which ever came first.

The common study-en-date was defined as the date when it was projected that 172 participants would have reached the primary endpoint criteria.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Clopidogrel (SR25990) intervention 2: placebo
Intervention descriptions: intervention 1: Form: reconstituted solution using Clopidogrel powder

Route: oral or enteric

Frequency: once daily

Dose: daily dose adjusted for weight intervention 2: Form: reconstituted solution using matching placebo powder

Route: oral or enteric

Frequency: once daily

Dose: daily dose adjusted for weight

Protocol documents:
Clinical trial NCT00552305
Conditions: Partial Epilepsies
Sponsor: UCB Pharma
Start date: 2001-08-01; Completion date: 2010-02-01
Enrollment: 370 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this trial is to determine whether lacosamide is safe and effective for long-term use in patients with partial-seizures from epilepsy.

Detailed description:

Arms: arm 1: 50mg and 100mg tablets up to 800 mg/day as twice a day (BID) dosing
Interventions: intervention 1: lacosamide
Intervention descriptions: intervention 1: 50mg and 100mg tablets up to 800 mg/day as twice a day (BID) dosing throughout the trial

Protocol documents:
Clinical trial NCT00784875
Conditions: Primary Insomnia Secondary Insomnia
Sponsor: Eli Lilly and Company
Start date: 2008-10-01; Completion date: 2010-02-01
Enrollment: 643 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare an investigational drug (LY2624803) with placebo and with zolpidem in the treatment of outpatients with chronic insomnia.

Detailed description:
Outpatients with chronic insomnia who participate in this study will be treated in each of four 2-week treatment periods with bedtime doses of either placebo, zolpidem, LY2624803 1 mg, or LY2624803 3 mg. Neither patients nor investigators will be told what treatments are being given in any treatment period. A patient who completes all four treatment periods will be treated with placebo in 1, 2, or 3 of the periods; with zolpidem in 0, 1, or 2 of the periods; and with LY2624803 in either 1 or 2 of the periods. No patient will receive placebo for all four of the 2-week treatment periods. All patients will receive LY2624803 for at least one of the four 2-week treatment periods. During each treatment period, patients will record information each morning about their sleep the night before, and each evening about their functioning since waking up. Patients will also wear wrist actigraphy devices to record their physical activity. At the conclusion of each treatment period, patients will answer questions about their sleep, functioning, health, and relative preference for treatments.

Arms: arm 1: 2-week double-blind placebo lead-in period. Period A is the first of four 2-week treatment periods. arm 2: Patients will receive LY2624803, zolpidem or placebo in a sequence of four 2-week treatment periods. Period B is the second of four 2-week treatment periods. arm 3: Patients will receive LY2624803, zolpidem or placebo in a sequence of four 2-week treatment periods. Period C is the third of four 2-week treatment periods. arm 4: Patients will receive LY2624803, zolpidem or placebo in a sequence of four 2-week treatment periods. Period D is the fourth of four 2-week treatment periods.
Interventions: intervention 1: LY2624803 intervention 2: LY2624803 intervention 3: Placebo intervention 4: zolpidem
Intervention descriptions: intervention 1: 1 mg, oral capsule, once nightly before bedtime intervention 2: 3 mg, oral capsule, once nightly before bedtime intervention 3: matching placebo (capsule or tablet), once nightly before bedtime intervention 4: 5 or 10 mg, oral tablet, once nightly before bedtime

Protocol documents:
Clinical trial NCT00807248
Conditions: Major Depressive Disorder
Sponsor: H. Lundbeck A/S
Start date: 2008-11-01; Completion date: 2010-02-01
Enrollment: 490 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the efficacy of escitalopram fixed dose 20 mg/day in combination with fixed doses of gaboxadol (5 and 10 mg/day) versus escitalopram fixed dose 20 mg/day after 8 weeks of treatment in patients with Major Depressive Disorder

Detailed description:
Subjects participating in this study will be respectively randomised (1:2:2:2) to receive either:

* placebo or
* escitalopram 20 mg/day or
* escitalopram 20 mg/day in combination with gaboxadol 5 mg/day or
* escitalopram 20 mg/day in combination with gaboxadol 10 mg/day

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Escitalopram placebo intervention 2: Gaboxadol placebo intervention 3: Escitalopram 20 mg intervention 4: Gaboxadol 5 mg intervention 5: Gaboxadol 10 mg
Intervention descriptions: intervention 1: Once daily before bedtime for 8 weeks intervention 2: Once daily before bedtime for 8 weeks intervention 3: Once daily before bedtime for 8 weeks intervention 4: Once daily before bedtime for 8 weeks intervention 5: Once daily before bedtime for 8 weeks

Protocol documents: