ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02271984
Conditions: Healthy
Keywords: Healthy Praziquantel L-PZQ PZQ MSC2499550A Bioavailability Pharmacokinetics
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2014-10-31; Completion date: 2014-12-31
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a phase I, open-label, randomized, 5 period, crossover, single-center trial. The purpose of this trial is to assess the relative bio-availability of L-praziquantel (L-PZQ \[MSC2499550A\]) oral dispersible tablet (ODT) formulation (150 milligram \[mg\]) versus the current marketed racemate praziquantel (PZQ) (Cysticide® 500 mg) formulation in healthy male volunteers under fed conditions.

Detailed description:

Arms: arm 1: MSC2499550A: 20 milligram per kilogram (mg/kg) under fed condition arm 2: Cysticide® 40 mg/kg under fed condition arm 3: C1:MSC2499550A :10 mg/kg under fed condition C2:MSC2499550A : 30 mg/kg under fed condition arm 4: MSC2499550A 20 mg/kg under fasting condition arm 5: MSC2499550A: 20 mg/kg directly disintegrated in mouth under fed condition
Interventions: intervention 1: MSC2499550A intervention 2: Cysticide intervention 3: MSC2499550A intervention 4: MSC2499550A intervention 5: MSC2499550A intervention 6: MSC2499550A
Intervention descriptions: intervention 1: Subjects will receive a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water under fed condition in one of the intervention periods. There will be a wash-out period of at least 7 days between each intervention period. intervention 2: Subjects will receive a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water, under fed condition in one of the intervention periods. There will be a wash-out period of at least 7 days between each of the intervention period. intervention 3: Subjects will receive a single oral dose of MSC2499550A formulation at 10 mg/kg dispersed in water under fed condition in one of the intervention periods. There will be a wash-out period of at least 7 days between each of the intervention period. intervention 4: Subjects will receive a single oral dose of MSC2499550A formulation at 30 mg/kg dispersed in water under fed condition in one of the intervention periods. There will be a wash-out period of at least 7 days between each of the intervention period. intervention 5: Subjects will receive a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water in fasted condition in one of the intervention periods. There will be a wash-out period of at least 7 days between each of the intervention period. intervention 6: Subjects will receive a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth without water under fed conditions in one of the intervention periods. There will be a wash-out period of at least 7 days between each of the intervention period.

Protocol documents:
Clinical trial NCT00892437
Conditions: HIV-1 Infection
Keywords: HIV HIV-1 Antiretroviral Treatment-Naive
Sponsor: Gilead Sciences
Start date: 2009-05-01; Completion date: 2015-01-01
Enrollment: 85 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the safety and efficacy of a regimen containing cobicistat-boosted atazanavir (ATV+COBI) plus emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) versus ritonavir-boosted atazanavir (ATV+RTV) plus FTC/TDF in HIV-1 infected, antiretroviral treatment-naive adults.

Participants will be randomized in a 2:1 ratio. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or \> 100,000 copies/mL) at screening. After Week 48, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments are unblinded, at which point all participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive ATV+COBI+FTC/TDF until COBI tablets become commercially available, or until Gilead Sciences elects to terminate the study.

Detailed description:

Arms: arm 1: COBI + RTV placebo +ATV+FTC/TDF for 48 weeks arm 2: RTV + COBI placebo +ATV+FTC/TDF for 48 weeks
Interventions: intervention 1: COBI intervention 2: RTV intervention 3: ATV intervention 4: FTC/TDF intervention 5: COBI placebo intervention 6: RTV placebo
Intervention descriptions: intervention 1: Cobicistat (COBI) 150 mg tablet administered orally once daily intervention 2: Ritonavir (RTV) 100 mg soft gelatin capsule administered orally once daily intervention 3: Atazanavir (ATV) 300 mg capsule administered orally once daily intervention 4: Emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination tablet administered orally once daily intervention 5: Placebo to match COBI administered orally once daily intervention 6: Placebo to match RTV administered orally once daily

Protocol documents:
Clinical trial NCT01082874
Conditions: Cardiovascular Disease
Keywords: Randomized Controlled Trial Blinded Clonidine acetyl-salicylic acid (ASA) Perioperative vascular complications Noncardiac surgery
Sponsor: Hamilton Health Sciences Corporation
Start date: 2010-07-01; Completion date: 2015-01-01
Enrollment: 10010 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
Major surgeries not involving the heart are common, and major heart problems during or after such surgeries represent a large population health problem. Few treatments to prevent heart problems around the time of surgery have been tested. There is encouraging data suggesting that small doses of Acetyl-Salicylic Acid (ASA) and Clonidine, which are two medications, given individually for a short period before and after major surgeries may prevent major heart problems. The POISE-2 Trial is a large international study to test if ASA and Clonidine can prevent heart attacks and deaths from heart problems around the time of surgery.

Detailed description:
POISE-2 is a multicentre, international, blinded, 2x2 factorial randomized controlled trial of acetyl-salicylic acid (ASA) and clonidine. The primary objective is to determine the impact of clonidine versus placebo and ASA versus placebo on the 30-day risk of all-cause mortality or nonfatal myocardial infarction in patients with, or at risk of, atherosclerotic disease who are undergoing noncardiac surgery. Patients in the POISE-2 trial will be randomly assigned to one of four groups: ASA and Clonidine together, ASA and Clonidine placebo, ASA placebo and Clonidine, or a ASA placebo and Clonidine placebo. Research personnel will follow patients at 30 days post-randomization and 1 year post-randomization.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Active Clonidine intervention 2: Placebo Clonidine intervention 3: Active ASA intervention 4: Placebo ASA
Intervention descriptions: intervention 1: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op. intervention 2: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op. intervention 3: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery intervention 4: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery

Protocol documents:
Clinical trial NCT01242514
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis OSKIRA Fostamatinib
Sponsor: AstraZeneca
Start date: 2011-01-01; Completion date: 2015-01-01
Enrollment: 1917 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the long term safety and tolerability of fostamatinib in patients with rheumatoid arthritis (RA).

Detailed description:

Arms: arm 1: Oral treatment arm 2: Oral treatment arm 3: Oral treatment
Interventions: intervention 1: Fostamatinib intervention 2: Fostamatinib intervention 3: Fostamatinib
Intervention descriptions: intervention 1: Fostamatinib 100mg twice daily intervention 2: Fostamatinib 150mg once daily intervention 3: Fostamatinib 100mg once daily

Protocol documents:
Clinical trial NCT01456936
Conditions: Smoking Cessation
Keywords: smoking cessation psychiatric disease
Sponsor: Pfizer
Start date: 2011-11-01; Completion date: 2015-01-01
Enrollment: 8144 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to assess varenicline and bupropion as aids to smoking cessation treatment in subjects with and without an established diagnosis of major psychiatric disorder and to characterize the neuropsychiatric safety profile (pre-specified adverse events (AEs) in both of these populations).

Detailed description:

Arms: arm 1: Subjects randomized to placebo will receive placebo treatments for all three study drugs. Blinded placebo will be provided for varenicline, bupropion hydrochloride and transdermal nicotine patch (NRT). In addition, subjects will receive blinded placebo treatments for the study drugs they are not randomized to receive. arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Placebo intervention 2: varenicline tartrate intervention 3: bupropion hydrochloride intervention 4: Nicotine Replacement Therapy Patch
Intervention descriptions: intervention 1: Triple dummy placebo for each treatment arm intervention 2: Subjects will be titrated to the full dose during the first week in the following manner: 0.5 mg (tablet form) once a day for 3 days, 0.5 mg twice a day for 4 days, then 1 mg twice a day for 11 weeks intervention 3: Subjects will receive 150 mg (tablet form) once a day for 3 days and then will take 150 mg twice a day for the remainder of the treatment period (11 weeks and 4 days). intervention 4: Subjects will start active dosing the morning of the Week 1 visit and will receive a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment.

Protocol documents:
Clinical trial NCT01724021
Conditions: Diffuse Large B-Cell Lymphoma, Non-Hodgkin's Lymphoma
Sponsor: Hoffmann-La Roche
Start date: 2012-12-01; Completion date: 2015-01-01
Enrollment: 743 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This multi-center, open-label, randomized study will evaluate the participant preference with subcutaneous versus intravenous administration of MabThera/Rituxan (rituximab) in participants with CD20+ diffuse large B-cell lymphoma or CD20+ follicular non-Hodgkin's lymphoma. In Arm A, participants will receive MabThera/Rituxan 375 mg/m2 intravenously (IV) on Day 1 of Cycle 1 and MabThera/Rituxan 1400 mg subcutaneously (SC) on Day 1 of Cycles 2-4, followed by MabThera/Rituxan IV in Cycles 5-8. Participants in Arm B will receive MabThera/Rituxan IV in Cycles 1-4 and SC in Cycles 5-8. All participants will receive 6-8 cycles of standard chemotherapy (according to local country practice) with 8 cycles of MabThera/Rituxan. Anticipated time on study treatment is up to 24 weeks.

Detailed description:

Arms: arm 1: Participants in Arm A received one cycle of rituximab 375 mg/m\^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m\^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator. arm 2: Participants in Arm B received four cycles of rituximab 375 mg/m\^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
Interventions: intervention 1: Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP) intervention 2: Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP) intervention 3: Bendamustine intervention 4: Rituximab intervention 5: Rituximab intervention 6: Rituximab intervention 7: Rituximab
Intervention descriptions: intervention 1: Standard chemotherapy intervention 2: Standard chemotherapy intervention 3: Standard chemotherapy intervention 4: 1400 mg subcutaneously (SC), Day 1 Cycles 2-4 intervention 5: 375 mg/m2 IV, Day 1 Cycles 1-4 intervention 6: 375 mg/m2 intravenously (IV), Day 1 Cycles 1 and 4-8 intervention 7: 1400 mg SC, Day 1 Cycles 5-8

Protocol documents:
Clinical trial NCT00228813
Conditions: Hematologic Malignancies
Sponsor: Emory University
Start date: 2004-04-01; Completion date: 2015-01-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purposes of this study are:

* To examine the engraftment rate in patients receiving in vivo T-cell-depleted G-CSF stimulated bone marrow from partially mismatched related donors.
* To evaluate the incidence and severity of acute and chronic graft-versus-host disease in patients receiving in vivo T-cell-depleted G-CSF stimulated bone marrow from partially mismatched related donors.

Detailed description:
This study is a single-arm, non-randomized feasibility study. Patients meeting the criteria for this study will be entered sequentially until completion or closure of the study. Early stopping rules will be employed to ascertain whether an unacceptable rate of toxicity (non-engraftment, and/or acute GVHD) occurs.

Patients will be prepared for transplant through the administration of the following conditioning regimen based on their primary disease:

* Total body irradiation (1400 rads in 8 fractionated doses) and high dose chemotherapy, including cytosine arabinoside, etoposide, and cyclophosphamide. Patients with bone marrow failure syndrome will not receive etoposide in the conditioning regimen.
* Post transplant immunosuppression prophylaxis against acute GVHD will include sequential administration of cyclosporine, methotrexate, basiliximab and mycophenolate.
* The donor will receive 3 daily G-CSF injections prior to marrow harvest starting on day -3. The injections may be initiated by the donor's primary physician prior to donor's arrival, or by the BMT service at Children's Healthcare of Atlanta.
* Patients will receive daily GM-CSF injections (250 mcg/m2) starting from day +7 post transplant until absolute neutrophil count (ANC) is greater than 2,000/µL for three days.

Arms: arm 1: Participants will receive bone marrow from donors who undergo Granulocyte Colony Stimulating Factor (G-CSF) stimulation prior to bone marrow collection.
Interventions: intervention 1: Granulocyte Colony Stimulating Factor
Intervention descriptions: intervention 1: FILGRASTIM: G-CSF (NEUPOGEN®) is administered as a short IV infusion over 30 minutes or subcutaneously. It is given beginning on day -3 for 3 days to the donor prior to the bone marrow harvest.

Drug Information: FILGRASTIM: G-CSF (Neupogen®) Formulation: G-CSF is available as a preservative-free solution for injection in 1.0 ml and 1.6 ml vials containing 300 mcg/ml.

Administration: G-CSF 5 mcg/kg/d will be given subcutaneously or as a short I.V. infusion over 30 minutes.

Recombinant GM-CSF at the dose of 250 mcg/m2 will be given intravenously from day +7 to help white counts recovery. The drug will be diluted in NS at a concentration of at least 10 mcg/ml.

Drug Information: Sargramostim (Leukine) Formulation: 250 mcg, 500 mcg lyophlized powder for injection

Protocol documents:
Clinical trial NCT00418028
Conditions: Metastatic Breast Cancer
Keywords: capecitabine schedule breast cancer
Sponsor: Hospital San Carlos, Madrid
Start date: 2005-09-01; Completion date: 2015-01-01
Enrollment: 195 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Capecitabine is active in metastatic breast cancer but the conventional schedule (1250 mg/m2/12 hr 2 weeks on, one week off) produces grade 2 or greater hand and foot syndrome in up to 50% of patients leading to those reductions. There are theoretical reasons to administer S-phase specific agents in continuous, protracted rather than intermittent schedules. The investigators study compares the standard schedule (1250 mg/m2/12 hr 2 weeks on, one week off) with a continuous administration schedule (800 mg/m2/12hr). The latter administer approximately the same cumulative dose of capecitabine as the standard schedule. The study hypothesis is that grade 2 or greater hand and foot syndrome will be reduced from 50% (standard arm) to 20% (experimental arm). The investigators assume similar antitumor activity in both arms.

Detailed description:
Capecitabine is active in metastatic breast cancer but the conventional schedule (1250 mg/m2/12 hr 2 weeks on, one week off) produces grade 2 or greater hand and foot syndrome in up to 50% of patients leading to those reductions. Some authors have tested continuous administration schedules of capecitabine, showing better tolerance and apparently similar antitumor activity. Capecitabine is a pro-drug of 5-FU and mimics an i.v. continuous infusion administration of this antimetabolite. On the other hand, there are theoretical reasons to administer S-phase specific agents in continuous, protracted rather than intermittent schedules. Our study compares the standard schedule(1250 mg/m2/12 hr 2 weeks on, one week off)with a continuous administration schule (800 mg/m2/12hr). The latter schedule administer approximately the same cumulative dose of capecitabine as the standard one. The study hypothesis is that grade 2 or greater hand and foot syndrome will be reduced from 50% (standard arm) to 20% (experimental arm). The investigators assume similar antitumor activity in both arms.

Arms: arm 1: Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome. arm 2: Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.
Interventions: intervention 1: Capecitabine
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00474851
Conditions: Endometriosis
Keywords: Endometriosis Adolescents Bone density GnRH Agonist Add-back therapy
Sponsor: Boston Children's Hospital
Start date: 2007-08-01; Completion date: 2015-01-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether a regimen of norethindrone acetate + placebo or norethindrone acetate + conjugated estrogens is superior in maintaining skeletal health and quality of life in adolescents treated with a GnRH agonist for endometriosis.

Detailed description:
Endometriosis has become increasingly recognized as a chronic illness which begins during adolescence. Untreated endometriosis may lead to chronic pain and infertility. As recognition of the need for prompt therapy increases, so does the length of time patients will be exposed to treatments. As a result, there exists a pressing need to evaluate adjunctive measures that may limit the associated negative health consequences of treatment.

A gonadotropin-releasing hormone (GnRH) agonist is one medication utilized for patients who have failed other treatments. While GnRH-agonists are effective in relieving symptoms, their long-term use is problematic. GnRH agonists induce a low-estrogen state, causing deleterious effects on bone mineralization. These negative consequences are especially important for our pediatric patients. Adolescence is the critical period in a woman's life for bone acquisition and attainment of peak bone mass. Anything that interferes with this process puts patients at risk for lifelong low bone density and future fracture.

"Add-back" therapy appears to be a promising adjunct to treatment for prevention of this bone loss. Daily therapy with low-doses of hormones preserves bone density in adult patients, without altering the efficacy of the GnRH-agonist. However, no data exist on the effect of add-back therapy in adolescents.

The aim of the current study is to evaluate the safety and efficacy of two add-back regimens, norethindrone acetate + placebo or norethindrone acetate + conjugated estrogens, for the preservation of skeletal health and quality of life in adolescents with endometriosis treated with a GnRH-agonist.

Arms: arm 1: Subjects randomized to the experimental arm received add-back therapy with norethindrone acetate 5 mg by mouth daily + conjugated equine estrogens 0.625 mg by mouth daily for the 12 months of study participation. arm 2: Subjects randomized to the experimental arm received add-back therapy with norethindrone acetate 5 mg by mouth daily + a placebo capsule by mouth daily for the 12 months of study participation.
Interventions: intervention 1: Norethindrone acetate + estrogens intervention 2: norethindrone acetate + placebo
Intervention descriptions: intervention 1: Norethindrone acetate 5 mg by mouth daily + Conjugated equine estrogens 0.625 mg by mouth daily intervention 2: norethindrone acetate 5 mg by mouth daily + Placebo capsule 1 pill by mouth daily

Protocol documents:
Clinical trial NCT00525161
Conditions: Breast Cancer
Keywords: breast cancer Sorafenib Nexavar Endocrine Therapy
Sponsor: Suleiman Massarweh
Start date: 2007-10-01; Completion date: 2015-01-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the clinical response rate to sorafenib when added to existing endocrine therapy in patients with advanced breast cancer.

Detailed description:
A pilot Phase II study adding sorafenib to endocrine therapy in 11 patients with metastatic estrogen receptor-positive breast cancer was conducted. Primary end point was response by Response Evaluation Criteria in Solid Tumors (RECIST) after 3 months of sorafenib. Secondary end points included safety, time to progression and biomarker modulation. The study closed early owing to slow accrual.

Arms: arm 1: Sorafenib \& Endocrine Therapy
Interventions: intervention 1: sorafenib
Intervention descriptions: intervention 1: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first.

Protocol documents: