ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00946088
Conditions: Pregnancy Complications
Sponsor: Stanford University
Start date: 2009-10-01; Completion date: 2015-03-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Preterm delivery is the most common cause of infant morbidity and mortality in the United States. Some women have episodes of preterm labor during their pregnancy which can be temporarily stopped. These women, however, are at high risk for delivering before term. At this time, we do not have sufficient evidence to use any medication to help prevent these women from delivering early. Recently, preliminary studies have shown that progesterone may help prevent some women at high risk for preterm delivery from delivering early. Our study will investigate whether progesterone can help this specific group of women, women with arrested preterm labor, deliver healthy infants at term.

Detailed description:
The purpose of this study is to test the efficacy of progesterone in prolonging human pregnancies complicated by arrested preterm labor. Animal labor has not been shown to be equivalent to human labor and would not be an appropriate substitute for this study.

In addition, this medication has been previously used in pregnant women without any evidence of significant harm to the mother or fetus. Women will be approached for enrollment in the study during their hospitalization for preterm labor. If they choose to enroll, they will have weekly MD visits at the obstetrical clinic, daily use of vaginal progesterone that will be self administered, and routine obstetric care at the time of recurrent labor and delivery. The daily progesterone is not a part of routine care for these patients. In addition, we will ask patients to fill out a written questionaire one week after starting the medication to describe any subjective symptoms that may be associated with this medication. Finally, we will assess the peripheral levels of progesterone with a blood draw prior to starting the mediation, one week after starting the medication, and at the time of recurrent pre-term labor or delivery. The first two of these blood draws will be in addition to the standard treatment. The final blood draw will involve collecting an extra sample at a time when the participant would normally have blood drawn as a part of routine care.

Arms: arm 1: Progesterone 400mg per vagina qhs. arm 2: Polyethylene glycol\&hydrogenated vegetable oil per vagina
Interventions: intervention 1: Progesterone intervention 2: Polyethylene glycol&hydrogenated vegetable oil.
Intervention descriptions: intervention 1: Progesterone 400 mg per vagina qhs. intervention 2: Placebo Comparator: Polyethylene glycol 400 distearate \& hydrogenated vegetable oil per vagina qhs.

Protocol documents:
Clinical trial NCT00979654
Conditions: Systemic Lupus Erythematosus
Keywords: Sifalimumab MEDI-545
Sponsor: MedImmune LLC
Start date: 2010-08-01; Completion date: 2015-03-01
Enrollment: 118 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to assess the safety and tolerability of sifalimumab in adult participants with active systemic lupus erythematosus (SLE) or active dermatomyositis (DM) or polymyositis (PM) who participated in the following clinical studies: MI-CP151, MI-CP152, or MI-CP179.

Detailed description:
The primary objective of this study is to evaluate the long-term safety and tolerability of multiple intravenous (IV) doses of sifalimumab in adult participants with active SLE or DM or PM who were previously treated with investigational product (sifalimumab or placebo) in one of the following sifalimumab clinical studies: MI-CP151, MI-CP152, or MI-CP179.

Arms: arm 1: All participants will receive intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg is increased to 600 mg with subsequent protocol amendment.
Interventions: intervention 1: Sifalimumab
Intervention descriptions: intervention 1: All participants will receive intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg is increased to 600 mg with subsequent protocol amendment.

Protocol documents:
Clinical trial NCT01027910
Conditions: Sarcoma
Keywords: PCI-24781 doxorubicin
Sponsor: Massachusetts General Hospital
Start date: 2009-02-01; Completion date: 2015-03-01
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to determine the safety and maximum tolerated dose of PCI-24781 that can be given safely with doxorubicin (phase I) and the safety and efficacy of PCI-24781 when used in combination with doxorubicin (phase II) in patients with advanced sarcomas. The study drug, PCI-24781, is believed to regulate genes involved in tumor cell growth. The other study drug, doxorubicin, is considered a standard chemotherapeutic treatment for advanced sarcoma patients. We hypothesize that combining PCI-24781 with doxorubicin can overcome chemoresistance to doxorubicin.

Detailed description:
* In the phase I portion of the study, since we are looking for the highest dose of PCI-24781 that can be administered safely without severe or unmanageable side effects in participants that have advanced sarcoma, not everyone who participates in this research study will receive the same dose of PCI-24871.
* Each treatment cycle is 3 weeks (21 days). Participants will take capsules of PCI-24871 for five consecutive days starting on Day 1 of each 3 week cycle. On Day 4 of each cycle, participants will come to the clinic to receive doxorubicin intravenously.
* At specific time intervals, participants will return to the clinic for the following tests and procedures: physical examination, vital signs, blood tests, urine test, EKG, assessment of the tumor by CT scan, and an ECHO or MUGA.
* Participants may remain on the study for a maximum of 6 cycles (about 4-5 months). After the last cycle, as long as the participant is showing benefit, they may elect to continue taking PCI-24781 alone, in which case they will continue in this research study until there is evidence of their tumor growing.

Arms: arm 1: PCI-24781 in combination with doxorubicin without mandated GCSF arm 2: PCI-24781 in combination with doxorubicin with mandated GCSF
Interventions: intervention 1: PCI-24781 intervention 2: Doxorubicin intervention 3: GCSF
Intervention descriptions: intervention 1: Capsules taken orally for 5 consecutive days starting on Day 1 of each 3 week cycle intervention 2: Administered intravenously on Day 4 of each 3 week cycle intervention 3: Administered on Day 5 of each 3 weeks cycle in Arm 1 if determined to be clinically indicated, and in all patients enrolled into Arm 2

Protocol documents:
Clinical trial NCT01029769
Conditions: Schizophrenia Schizoaffective Disorder Schizophreniform Disorder
Sponsor: Technical University of Munich
Start date: 2009-12-01; Completion date: 2015-03-01
Enrollment: 350 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The main aim of the trial is to study whether a change of medication in non-responders to a two-weeks antipsychotic drug trial is more effective than continued treatment with the same antipsychotic. Hypothesis: Non-responders who are switched at 2 weeks to another antipsychotic are more frequently in symptomatic remission at week 8 than non-responders who stay on the same antipsychotic

Detailed description:
The patients will be randomised to a double-blind 2 week run in phase with fixed doses of either oral amisulpride 800 mg/day or olanzapine 20mg/day.

Those participants who have not responded to treatment at two weeks (PANSS improvement \<25%) will be randomised to a 6 week double blind flexible dose phase:

1. Experimental intervention: switch to the other antipsychotic (oral olanzapine 5-20mg/d or oral amisulpride 200-800 mg/d)
2. Control intervention: continuation with the same drug as in the first 2 weeks in flexible dose ranges as above for another six weeks Those participants who have responded at week 2 (≥25% PANSS reduction) will continue on the same drug in flexible dose ranges as above Total duration of intervention per patient: 8 weeks

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Olanzapine or amisulpride
Intervention descriptions: intervention 1: Oral olanzapine 5mg to 20mg/d OR oral amisulpride 200mg to 800mg/d; both preferably once daily, both encapsulated for blinding

Protocol documents:
Clinical trial NCT01066156
Conditions: Post-Traumatic Stress Disorder
Keywords: Post-traumatic Stress Disorder PTSD Seroquel fMRI
Sponsor: Cambridge Health Alliance
Start date: 2010-02-01; Completion date: 2015-03-01
Enrollment: 34 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This 8 weeks study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD.

Detailed description:
An initial telephone interview will be conducted to determine if potential subjects meet the basic study requirements. If no obvious counterindications are present, subjects will be scheduled for a screening visit. After briefing the subjects on the reasons for the research, they will be given an opportunity to read the Informed Consent Form, approved by the Cambridge Health Alliance Institutional ReviewBoard, and to ask questions prior to signing it. Subjects will be given a copy of the signed Consent Form. Each subject will complete a standardized interview schedule designed to obtain personal and background data along with psychodiagnostic and psychometric evaluations. An open-label treatment will be utilized for all patients. Seroquel tablets will be flexibly dosed and begun at a target dose of 25 mg per day and taken over an 8 week period.

Arms: arm 1: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD
Interventions: intervention 1: Seroquel
Intervention descriptions: intervention 1: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD

Protocol documents:
Clinical trial NCT01076504
Conditions: Extensive-Stage Small Cell Lung Cancer
Keywords: SCLC Amrubicin Carboplatin Pegfilgrastim Neulasta
Sponsor: SCRI Development Innovations, LLC
Start date: 2009-12-01; Completion date: 2015-03-01
Enrollment: 81 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This proposed trial will investigate the combination of amrubicin and carboplatin in the first-line treatment of patients with extensive-stage small cell lung cancer (ES- SCLC). Since myelosuppression is the most common toxicity produced by this drug combination, pegfilgrastim will be administered with each treatment cycle. This trial will be the first clinical trial to evaluate a combination of amrubicin and carboplatin in the first-line treatment of ES SCLC in a U.S. population.

Detailed description:

Arms: arm 1: Systemic therapy
Interventions: intervention 1: Amrubicin intervention 2: Carboplatin intervention 3: Pegfilgrastim
Intervention descriptions: intervention 1: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle intervention 2: AUC=5 IV, Day 1 of each 3-week treatment cycle intervention 3: 6 mg SQ on Day 4 of each 3 week treatment cycle

Protocol documents:
Clinical trial NCT01083641
Conditions: Female Breast Cancer
Keywords: Breast Cancer
Sponsor: University of Wisconsin, Madison
Start date: 2010-01-01; Completion date: 2015-03-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the effectiveness of Estradiol treatment for advanced breast cancer that is hormone receptor negative and Her2/neu negative. The study will also use tumor tissue from your original diagnosis or from a biopsy you may have had for your cancer to look at hormone receptors in the lab. The tissue left over from your previous surgery or a previous biopsy will be used for research tests to check whether a different estrogen receptor (estrogen receptor beta) is seen in the tumor and if that makes estrogen work better.

Detailed description:

Arms: arm 1: Estrogen therapy
Interventions: intervention 1: Estradiol
Intervention descriptions: intervention 1: 10mg oral three times daily

Protocol documents:
Clinical trial NCT01084876
Conditions: Metastatic Breast Cancer
Keywords: Herceptin metastatic breast cancer CT-P6 Her 2-positive
Sponsor: Celltrion
Start date: 2010-06-01; Completion date: 2015-03-01
Enrollment: 475 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to demonstrate equivalence

Detailed description:
Patients will receive CT-P6 or Herceptin every 3 weeks.

Arms: arm 1: CT-P6 was administered at a loading dose of 8 mg/kg body weight by intravenous (IV) infusion over 90 minutes on Day 1, Cycle 1, then at 6 mg/kg repeated at 3-weekly intervals until disease progression, death or discontinuation.

Paclitaxel was administered at a dose of 175 mg/m2 body surface area (BSA) as a continuous 3-hour IV infusion on the day following the first dose of study drug (CT-P6). If the first dose of study drug was well tolerated, subsequent doses of paclitaxel were given immediately after the next dose of study drug. Paclitaxel cycles were repeated every 3 weeks until disease progression, death or discontinuation. arm 2: Herceptin was administered at a loading dose of 8 mg/kg body weight by IV infusion over 90 minutes on Day 1, Cycle 1, then at 6 mg/kg repeated at 3-weekly intervals until disease progression, death or discontinuation.

Paclitaxel was administered at a dose of 175 mg/m2 BSA as a continuous 3-hour IV infusion on the day following the first dose of study drug (Herceptin). If the first dose of study drug was well tolerated, subsequent doses of paclitaxel were given immediately after the next dose of study drug. Paclitaxel cycles were repeated every 3 weeks until disease progression, death or discontinuation.
Interventions: intervention 1: CT-P6 intervention 2: Herceptin intervention 3: Paclitaxel
Intervention descriptions: intervention 1: Administered every 3 weeks intervention 2: Administered every 3 weeks intervention 3: Administered every 3 weeks

Protocol documents:
Clinical trial NCT01090921
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma Bortezomib Newly diagnosed Newly diagnosed Multiple Myeloma
Sponsor: Boston VA Research Institute, Inc.
Start date: 2007-05-01; Completion date: 2015-03-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a research study to see if a new drug called bortezomib is useful to treat multiple myeloma in people who are newly diagnosed, and have not yet received treatment for their disease. VELCADE® (bortezomib) for Injection is a drug under development by Millennium Pharmaceuticals, Inc.

Detailed description:
This study is a multi-site study which will enroll up to 50 patients with multiple myeloma who have not had prior treatment.

Prior to starting treatment individuals will be evaluated to determine if they are eligible to participate in the study. There are certain prestudy test that are required: physical exam, blood tests, ECG, chest x-ray, skeletal survey, bone marrow aspirate and biopsy to confirm the diagnosis of multiple myeloma and to determine baseline health status.

Before beginning each treatment cycle and at the end of the study, patients will have protein studies (including blood and urine) to see if they are responding to the treatment. Before each weekly treatment cycle patients will also have blood tests for red and white blood cells and platelets, and blood chemistry tests for electrolytes, kidney and liver function, calcium and blood sugar.

Patients may receive up to 6 cycles of treatment. At the end of the study, individuals who have responded to treatment will be seen every two months to check for disease progression.

Arms: arm 1: Bortezomib is administered at a dose of 1.6mg/m2 IV push over 3 to 5 seconds. Treatment is administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle. Dexamethasone is also administered at a dose of 40mg daily on day of and day after each dose of Bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone. The study duration for a given subject will be approximately 30 weeks.
Interventions: intervention 1: Bortezomib
Intervention descriptions: intervention 1: Bortezomib will be administered at a dose of 1.6 mg/m2 IV push. Treatment will be administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle.

Dexamethasone will also be administered at a dose of 40mg on the day of and day after each dose of bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone.

Protocol documents:
Clinical trial NCT01147809
Conditions: Thrombocytopaenia
Keywords: Solid Tumor Eltrombopag chemotherapy-induced thrombocytopenia Thrombocytopenia
Sponsor: GlaxoSmithKline
Start date: 2010-06-01; Completion date: 2015-03-01
Enrollment: 130 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The present study is a randomized, blinded, placebo-controlled, two-Phase, sequential cohort, dose finding study to assess the safety and efficacy of eltrombopag in patients with solid tumors receiving gemcitabine monotherapy or the combination of gemcitabine plus carboplatin or cisplatin. Phase I of the study will examine safety and tolerability of various doses of eltrombopag to identify a dose and schedule of eltrombopag. Phase II will confirm that the chosen dose and schedule of eltrombopag from Phase I can deliver clinically meaningful benefit(s) to thrombocytopenic patients by improving platelet numbers.

Detailed description:

Arms: arm 1: Drug: eltrombopag olamine thrombopoietin receptor agonist arm 2: Other: Placebo Placebo tablets with no active pharmaceutical ingredient
Interventions: intervention 1: Eltrombopag olamine intervention 2: Placebo
Intervention descriptions: intervention 1: thrombopoietin receptor agonist intervention 2: Placebo tablets with no active pharmaceutical ingredient

Protocol documents:
Clinical trial NCT01155284
Conditions: Type 1 Diabetes
Keywords: diabetes HGB A1C Beta Cell Regeneration
Sponsor: Sanford Health
Start date: 2010-08-01; Completion date: 2015-03-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Sanford Research/USD proposes to study the combination therapy of oral administration of sitagliptin and lansoprazole versus placebo for the preservation of pancreatic beta cells still present in patients with recent-onset diabetes and possibly regenerating their beta cells, while safely down-regulating the autoimmune response directed against the beta cells.

Detailed description:

Arms: arm 1: Sitagliptin 50mg co-administered with Lansoprazole 30mg. Subjects age 11-17 years at Visit 2 will take 1 capsule of each once daily Subjects age 18-45 years at Visit 2 will take 2 capsules of each once daily arm 2: Sitagliptin Placebo and Lansoprazole placebo capsules will be administered. Subjects age 11-17 years at Visit 2 will take 1 placebo capsule of each once daily Subjects age 18-45 years at Visit 2 will take 2 placebo capsules of each once daily
Interventions: intervention 1: Sitagliptin and Lansoprazole intervention 2: Placebo
Intervention descriptions: intervention 1: Sitagliptin (dispensed as 50 mg capsules)and Lansoprazole(dispensed as 30 mg capsules) or matching placebo

* Subjects age 11-17 years at Visit 2 will take 1 capsule once daily
* Subjects age 18-45 years at Visit 2 will take 2 capsules once daily intervention 2: Sitagliptin 50mg and Lansoprazole 30 mg or matching placebo will be given daily for 12 months. Subjects age 11-17 at visit 2 will take 1 capsule daily; age 18-45 will take 2 capsules daily.

Protocol documents:
Clinical trial NCT01239394
Conditions: Follicular Lymphoma Marginal Zone Lymphoma Small Lymphocytic Lymphoma
Keywords: NHL ofatumumab
Sponsor: Massachusetts General Hospital
Start date: 2010-12-01; Completion date: 2015-03-01
Enrollment: 43 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Ofatumumab is a drug that works by attaching to the CD20 molecule found on the surface of cancerous B cells, and then triggering the death of those cells. It is approved by the FDA for treatment of another B-cell cancer, chronic lymphocytic leukemia, and also has evidence of success in people who's B-cell lymphomas have relapsed after initial treatments. In this research study we are looking to see if ofatumumab is effective and safe in treating previously untreated B-cell NHL.

Detailed description:
* Participants will receive ofatumumab once a week for 8 weeks by intravenous infusion (Days 1, 8, 15, 22, 29, 36, 43, and 50).
* Participants will be seen weekly during the 8 week treatment period and will have the following tests and procedures performed: Blood tests, performance status and physical examination.

Arms: arm 1: single-arm, open-label, interventional
Interventions: intervention 1: ofatumumab
Intervention descriptions: intervention 1: Weekly infusion for 8 weeks

Protocol documents:
Clinical trial NCT01239732
Conditions: Ovarian Cancer
Sponsor: Hoffmann-La Roche
Start date: 2010-12-01; Completion date: 2015-03-01
Enrollment: 1021 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, non-comparative, multi-center study will assess the safety profile and efficacy of Avastin (bevacizumab) when added to carboplatin and paclitaxel therapy in participants with epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma. Participants will receive 15 milligrams/kilogram (mg/kg) Avastin intravenously (IV) on Day 1 of every cycle for up to 36 cycles of 3 weeks each, carboplatin (area under the plasma concentration-time curve \[AUC\] 5-6 mg/ml/min) on Day 1 every 3 weeks for a maximum of 8 cycles and paclitaxel 175 milligram per square meter (mg/m\^2) on Day 1 every 3 weeks or 80 mg/m\^2 every week for a maximum of 8 cycles. The anticipated time on study drug will be 108 weeks or until disease progression or unacceptable toxicity.

Detailed description:

Arms: arm 1: Participants will receive bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol defined disease progression or until unacceptable toxicity (whichever occurred first). Participants will receive paclitaxel 175 mg/m\^2 IV on Day 1 every 3 weeks or 80 mg/m\^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol defined disease progression, or unacceptable toxicity (whichever occurred first).
Interventions: intervention 1: Paclitaxel intervention 2: Bevacizumab intervention 3: Carboplatin
Intervention descriptions: intervention 1: 175 mg/m\^2 on Day 1 every 3 weeks or at a dose of 80 mg/m\^2 every week for a minimum of 4 cycles and not more than 8 cycles or until disease progression or unacceptable toxicity, whichever occurs first intervention 2: 15 mg/kg intravenously on Day 1 of every cycle for up to 36 cycles of 3 weeks each or until disease progression or unacceptable toxicity, whichever occurs first intervention 3: AUC 5-6 mg/ml/min on Day 1 every 3 weeks for a minimum of 4 cycles and not more than 8 cycles or until disease progression or unacceptable toxicity, whichever occurs first

Protocol documents: