ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01144442
Conditions: Ovarian Cancer Fallopian Tube Cancer Peritoneal Carcinoma
Keywords: recurrent ovarian cancer recurrent fallopian tube cancer recurrent peritoneal carcinoma
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 2010-07-27; Completion date: 2015-05-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, pilot study in patients with a diagnosis of recurrent ovarian, fallopian tube or primary peritoneal carcinoma who have undergone standard cytoreductive surgery following by adjuvant chemotherapy. It is expected that this first surgery was optimal - as defined as no residual tumor \> or = 1 centimeter. Patient has clinical evidence of a first recurrence. The patient undergoes surgery and isotonic normal saline (perfusate) heated and administered into the abdomen, followed by hyperthermic intraperitoneal chemotherapy infusion (HIPC) administering carboplatin (chemotherapy). Six weeks after surgery patients will receive adjuvant chemotherapy with Paclitaxel and Carboplatin for 6 cycles.

Detailed description:
OBJECTIVES

* The primary objectives are

  * to determine the clinical response of hyperthermic intraperitoneal chemotherapy (HIPC) in patients at the time of first clinical recurrence of ovarian, fallopian tube, or primary peritoneal carcinoma
  * to determine the feasibility of delivering HIPC in a recurrent setting.
* Secondary objectives are

  * to determine disease free survival (DFS) and overall survival (OS),
  * to determine treatment related changes in quality of life (QOL)
  * to monitor the toxicities and complications associated with HIPC.

Arms: arm 1: None
Interventions: intervention 1: Hyperthermic intraperitoneal chemotherapy with Carboplatin intervention 2: Isotonic saline (perfusate) intervention 3: Surgery intervention 4: Carboplatin intervention 5: Paclitaxel
Intervention descriptions: intervention 1: Carboplatin at a dose of 1000mg/m\^2 will be added to the perfusate once circulating levels reach 1000-1500cc/minute. The circulation of the chemotherapy impregnated perfusate will be performed for 90 minutes. intervention 2: The HIPC infusion will be performed with a closed abdomen technique. The perfusate will be isotonic saline heated to 40-42° Celsius. intervention 3: The abdominal incision will be performed in a vertical fashion extending from the supra-pubic region to around the umbilicus.

If cytoreductive surgery is required, it will be performed at this time and proceed in standard approach. intervention 4: The scheduled systemic chemotherapy is paclitaxel 175mg/m2 and carboplatin AUC 6 every 3 weeks for 6 total cycles. intervention 5: The scheduled systemic chemotherapy is paclitaxel 175mg/m2 and carboplatin AUC 6 every 3 weeks for 6 total cycles.

Protocol documents:
Clinical trial NCT01219777
Conditions: Ovarian Cancer Primary Peritoneal Cancer Fallopian Tube Cancer
Keywords: bevacizumab paclitaxel carboplatin ovarian cancer fallopian tube primary peritoneal
Sponsor: Ritu Salani
Start date: 2010-09-01; Completion date: 2015-05-01
Enrollment: 9 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the maximum tolerated dose (MTD) of intravenous weekly paclitaxel given with intravenous carboplatin and bevacizumab in patients with epithelial ovarian, primary peritoneal, or fallopian tube carcinoma that are to receive neoadjuvant chemotherapy (prior to surgical cytoreduction). Patients will then undergo surgery which will allow an objective measure of response to the above regimen as well as assessment of surgical outcomes.

Detailed description:
Phase I study proposed to evaluate:

* Tolerability of IV regimen carboplatin, paclitaxel and bevacizumab in the neoadjuvant setting prior to surgery.
* Safety/Toxicity of IV regimen in this patient population
* Treatment is Carboplatin area under the concentration curve (AUC) 5, Bevacizumab 15mg/m2, and starting dose of paclitaxel of 60mg/m2 and will be escalated in intervals of 10mg/m2 to a maximum dose of 80mg/m2.
* Patients will receive cycles 1-3 of carboplatin, bevacizumab, and paclitaxel and then cycle 4 will be carboplatin and paclitaxel followed by surgical intervention within 6 weeks of cycle 4.
* Post surgical treatment per physician discretion

Arms: arm 1: AUC 5.0 or 6.0 arm 2: 15 mg/kg arm 3: 60-80 mg/m2
Interventions: intervention 1: carboplatin intervention 2: Bevacizumab intervention 3: Paclitaxel
Intervention descriptions: intervention 1: Carboplatin AUC 5.0 or 6.0 will be administered on day 1 during cycle 1-3. Treatment cycle consists of 21 days duration. intervention 2: Bevacizumab 15 mg/kg administered on Day 1 during cycle 1-3. Treatment cycle consists of 21 days duration. intervention 3: 60-80 mg/m2 administered on Day 1, 8 \& 15 during cycle 1-3. Treatment cycle consists of 21 days duration.

Protocol documents:
Clinical trial NCT01229735
Conditions: Epilepsy
Keywords: levetiracetam topiramate epilepsy partial seizures
Sponsor: UCB Korea Co., Ltd.
Start date: 2010-11-01; Completion date: 2015-05-01
Enrollment: 343 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the long-term effects of levetiracetam on retention rate in subjects with refractory partial onset seizure that are not fully controlled with 1 to 3 concomitant antiepileptic drugs, compared to topiramate as add-on therapy during 52 weeks.

Detailed description:

Arms: arm 1: 250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks arm 2: 25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
Interventions: intervention 1: Levetiracetam intervention 2: Topiramate
Intervention descriptions: intervention 1: 250 mg and 500 mg levetiracetam tablet 1000 mg/day (500 mg bid) levetiracetam (maximum to 3000 mg/day) Duration: maximum 52 weeks intervention 2: 25 mg and 100 mg topiramate tablet 100 mg/day(50 mg bid) topiramate (maximum to 400 mg/day) Duration: maximum 52 weeks

Protocol documents:
Clinical trial NCT01262365
Conditions: Systemic Lupus Erythematosus
Keywords: Lupus Monoclonal antibody B-Cell immunotherapy Epratuzumab
Sponsor: UCB Pharma
Start date: 2010-12-01; Completion date: 2015-05-01
Enrollment: 793 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE)

Detailed description:

Arms: arm 1: Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles arm 2: 600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles arm 3: 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles
Interventions: intervention 1: Epratuzumab intervention 2: Epratuzumab intervention 3: Placebo
Intervention descriptions: intervention 1: 600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12- week treatment cycles intervention 2: 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles intervention 3: Placebo infusions delivered weekly for 4 weeks over four 12-week treatment cycles

Protocol documents:
Clinical trial NCT01265667
Conditions: Plaque Psoriasis
Keywords: Psoriasis Plaque psoriasis
Sponsor: Can-Fite BioPharma
Start date: 2011-07-01; Completion date: 2015-05-01
Enrollment: 293 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Eligible patients with Psoriasis will be treated with CF101 or placebo twice daily for 16 weeks. All subjects will receive open-lable CF101 in weeks 17-32.

Detailed description:
Eligible patients will be randomly assigned to parallel dosing groups of CF101 2 mg or matching placebo tablets twice daily (BID) in a 1:1 ratio for the 16-week controlled treatment period. Approximately 94 patients will be assigned to each group.

Medication will be taken orally BID for 16 weeks in a double-blinded fashion. At the end of 16 weeks, all patients assigned to CF101 will continue CF101, while patients originally assigned to placebo will be reassigned to CF101.

Assessment of peripheral blood mononuclear cell (PBMC) adenosine A3 receptor (A3AR) expression at baseline and during treatment with CF101 in selected sites.

Arms: arm 1: CF101 2mg oral tablets arm 2: Placebo oral tablets
Interventions: intervention 1: CF101 intervention 2: Placebo
Intervention descriptions: intervention 1: orally q12h intervention 2: orally q12h

Protocol documents:
Clinical trial NCT01278173
Conditions: Adult Refractory Complex Partial Seizures
Keywords: Vigabatrin-associated vision change Adult refractory complex partial seizures CPS Epilepsy Seizures Brain diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Enzyme Inhibitors GABA Agents
Sponsor: Lundbeck LLC
Start date: 2010-12-01; Completion date: 2015-05-01
Enrollment: 65 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to evaluate the change in visual fields by means of automated static perimetry and to evaluate the change in retinal structure by means of spectral domain optical coherence tomography (SD-OCT) in adult patients with refractory complex partial seizures (CPS) being treated with vigabatrin (Sabril®)

Detailed description:
Multicenter, prospective open-label study with approximately 25 sites in the US that specialize in caring for adult patients with refractory CPS

* Sites must have access to Humphrey static perimetry and to Spectralis SD-OCT.
* All vision test results will be sent to the central readers for evaluation.
* Additional study tests:

  * The Columbia Suicide Severity Rating Scale (C-SSRS)
  * The National Eye Institute Visual Field Questionnaire-39 (NEI VFQ-39)
  * A whole blood sample for specific analysis of DNA characteristics
  * An optional whole blood sample for exploratory analysis of DNA characteristics
  * Plasma samples for bioanalytical analysis of vigabatrin and blood samples for taurine biomarker analysis

Arms: arm 1: None
Interventions: intervention 1: Sabril
Intervention descriptions: intervention 1: Sabril: 500 mg tablets, orally. Physicians will dose their patients according to guidance provided in the product label.

Protocol documents:
Clinical trial NCT01286753
Conditions: Neoplasms
Sponsor: Hoffmann-La Roche
Start date: 2011-06-01; Completion date: 2015-05-01
Enrollment: 51 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This open-label, multi-center study will evaluate the safety and efficacy of Vemurafenib (RO5185426) in participants with metastatic or unresectable papillary thyroid cancer (PTC) positive for the BRAF V600 mutation and resistant to radioactive iodine therapy. Participants will receive vemurafenib 960 milligrams (mg) orally twice daily until progressive disease or unacceptable toxicity occurs.

Detailed description:

Arms: arm 1: Vemurafenib in participants naive to any prior systemic TKI therapy. arm 2: Vemurafenib in participants previously treated with TKI therapy active against vascular endothelial growth factor receptor 2 (VEGFR).
Interventions: intervention 1: Vemurafenib
Intervention descriptions: intervention 1: Vemurafenib 960 mg orally twice daily.

Protocol documents:
Clinical trial NCT01328041
Conditions: Infection, Human Immunodeficiency Virus
Keywords: GSK1349572 resistance to raltegravir or elvitegravir Integrase inhibitor ART-experienced dolutegravir
Sponsor: ViiV Healthcare
Start date: 2011-05-01; Completion date: 2015-05-01
Enrollment: 183 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this trial is to assess the antiviral activity and safety of a dolutegravir (DTG) containing regimen in HIV-1 infected, antiretroviral therapy (ART)-experienced adults with current or historical failure on an integrase inhibitor (INI) containing regimen. The study will assess DTG 50mg twice daily administered initially with the current failing ART regimen but then with an optimised background ART regimen (OBR) after Day 7. The first analyses will be conducted after the last subject enrolled has completed 24 weeks. Subjects may remain on study after Week 24.

Detailed description:
ING112574 is a Phase 3, multicentre, open-label, single arm study to assess the antiviral activity and safety of DTG containing regimen in HIV-1 infected ART-experienced adults with historical or current evidence of resistance to RAL or ELV. Initially, a minimum of 100 subjects will be enrolled to receive DTG 50mg twice daily with the current failing regimen for 7 days but with OBR from Day 8. Subjects must also have documented genotypic and/or phenotypic resistance to at least one compound in two or more of the other approved classes of ART but must also be able to include at least one fully active drug in the OBR to be started Day 8. The first data cut will take place after the (approximate) 100th subject enrolled completes the Week 24 visit. Enrollment will continue until a further 50 to 100 subjects have been recruited. All subjects who successfully complete 24 weeks of treatment will continue to have access to DTG until it is locally available as long as they continue to derive clinical benefit.

ViiV Healthcare is the sponsor of this study.

Arms: arm 1: dolutegravir plus background antiretroviral therapy optimised at Day 8
Interventions: intervention 1: dolutegravir
Intervention descriptions: intervention 1: 50 mg twice daily

Protocol documents:
Clinical trial NCT01384591
Conditions: Aging
Keywords: oxidative stress blood flow antioxidant muscle elderly
Sponsor: The University of Texas Medical Branch, Galveston
Start date: 2011-07-01; Completion date: 2015-05-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The general hypothesis is that elderly have diminished nutritive flow to skeletal muscle and impaired capacity for building muscle. In aging populations, this decreased ability to build muscle may represent a tipping point in the progression towards chronic physical frailty and disability. The goal is to examine whether novel pharmacologic therapies can improve nutritive blood flow to the muscles and muscle building in the elderly.

The purpose of this study is 1) to determine if losartan administration will enhance blood flow and 2) to determine if N-acetylcysteine (NAC) will enhance blood flow.

The investigators will study community dwelling, healthy older men and women (60-85 years). Subjects will be randomized to one of three groups:

Experimental Group 1: Placebo losartan and placebo N-acetylcysteine (NAC). Experimental Group 2: losartan (25mg/dose) and placebo N-acetylcysteine (NAC). Experimental Group 3: N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo

Subjects will admit to the clinic on day 1 of the study. Baseline testing consisting of leg blood flow (LBF), contrast enhanced ultrasound, handgrip testing and fatigue questionnaires. After testing is completed the subjects will recieve their first dose of NAC/ losartan/ placebo with dinner. Subjects will be fasted after 10 pm. On day 2, leg blood flow (LBF) will be measured approximately 12 hours post dose 1. Subjects will receive their second dose of NAC/ losartan/ placebo. Leg blood flow will be measured 1 hour and 2 hours post dose 2 of study interventions. The subjects will eat a meal and receive their third dose of the study intervention. Leg blood flow will be repeated at 1 hour and 2 hours post dose 3. Appoximately 30 minutes after dose 3 of the study intervention, handgrip testing will be performed and fatigue questionnaires completed.

Detailed description:

Arms: arm 1: losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2. arm 2: Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2. arm 3: N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Interventions: intervention 1: N-acetylcysteine intervention 2: Losartan intervention 3: Placebo losartan intervention 4: Placebo N-acetylcysteine
Intervention descriptions: intervention 1: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2. intervention 2: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2. intervention 3: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2. intervention 4: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.

Protocol documents:
Clinical trial NCT01432145
Conditions: Breast Cancer Ovarian Cancer
Keywords: BRCA defective
Sponsor: University of Oxford
Start date: 2011-05-01; Completion date: 2015-05-01
Enrollment: 74 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy and safety of 6-mercaptopurine (6MP) in combination with methotrexate (MTX) in patients with breast or ovarian cancer who are known to have a BRCA (breast cancer gene) mutation.

Detailed description:
This study will evaluate the efficacy and safety of 6-mercaptopurine (6MP) in combination with methotrexate (MTX) in patients with breast or ovarian cancer who are known to have a BRCA (breast cancer gene) mutation. 6MP is used instead of thioguanine(6TG) as it is converted to the same cytotoxic moiety as 6TG, ie. thioguanine nucleotides, but with reduced toxic effects. Low dose methotrexate is used in combination with 6MP as it promotes the formation of thioguanine nucleotides.

Arms: arm 1: 6-Mercaptopurine 55mg/m2 per day, and methotrexate 15mg/m2 per week
Interventions: intervention 1: 6-Mercaptopurine intervention 2: Methotrexate
Intervention descriptions: intervention 1: 6-Mercaptopurine (6MP) 55mg/m2 body surface area, administered orally (PO) once a day (od) in the morning 1 hour after eating, on a continuous schedule. One cycle is 28 days. Treatment is given continuously until disease progression. intervention 2: Methotrexate (MTX) 15 mg/m2 taken orally, once a week, in the morning. One cycle is 28 days. Treatment is given continuously until disease progression.

Protocol documents:
Clinical trial NCT01433471
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis Trichuris Suis Ova Inflammatory Bowel Disease Mucus
Sponsor: NYU Langone Health
Start date: 2012-08-01; Completion date: 2015-05-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to understand the immune response activated in the human gastrointestinal tract by Trichuris Suis Ova (TSO) in patients with ulcerative colitis.

Detailed description:
The concept of helminthic therapy (using worms to treat diseases) is supported by experiments in mouse models as well as several clinical studies. TSO, which are purified eggs from the porcine whipworm Trichuris suis, are being investigated in clinical trials as a potential therapeutic agent for the treatment of active Crohn's disease, relapsing multiple sclerosis, peanut and tree nut allergy, and adults with autistic disorders.

The goal of this study is to understand the immune mechanisms activated in the human gastrointestinal tract by treatment with TSO, which may lead to improvements in the symptoms of ulcerative colitis (UC). TSO have been shown to have a clinical benefit on a subset of patients with UC in a previous randomized placebo-controlled trial (Summers et al. 2005). However, the mechanisms of action of TSO on the intestinal mucosa remain unclear.

We propose an exploratory 24-week mechanistic randomized double-blind placebo-controlled crossover study of TSO in patients with established and active UC to better characterize similarities and differences in the immune mechanisms of the intestinal mucosa in response to TSO. We hypothesize that treatment with TSO will lead to an anti-inflammatory immune response in some individuals with UC through an increase in intestinal mucus production and modulation of Th1, Th2, Th17, and T-regulatory effector lymphocyte populations.

Arms: arm 1: Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover arm 2: Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover
Interventions: intervention 1: Trichuris suis ova
Intervention descriptions: intervention 1: 2,500 eggs by mouth every two weeks for 12 weeks

Protocol documents:
Clinical trial NCT01453153
Conditions: Stage IV Pancreatic Cancer
Keywords: pancreatic Cancer Stage IV untreated
Sponsor: Halozyme Therapeutics
Start date: 2011-09-01; Completion date: 2015-05-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase 1B: Open label (all patients receive PEGPH20+gemcitabine), dose escalation, safety and tolerability study to determine the safe dose of PEGPH20 to use in combination with gemcitabine in Stage IV previously untreated pancreatic cancer patients.

Phase 2: Randomized, double blind study to compare the effect of overall survival of gemcitabine plus PEGPH20 vs gemcitabine plus placebo in Stage IV previously untreated pancreatic cancer patients.

Detailed description:
PEGPH20 is a PEGylated version of human recombinant PH20 hyaluronidase that, in preclinical studies, has been shown to remove HA from the extracellular matrix surrounding tumor cells by depolymerizing this substrate. 87% of pancreatic ductal adenocarcinomas (PDA) overexpress HA. PDA tumor tissue may be especially sensitive to the HA-degradation properties of PEGPH20 and thus more responsive to the cytotoxic effects of a given dose of gemcitabine. Modifying the extracellular environment to increase the penetration and efficacy of anti-cancer agents represents a novel approach to treating pancreatic cancer and may provide important therapeutic outcomes in patients with Stage IV Previously Untreated Pancreatic Cancer.

This Phase 1B/2 study will assess safety, tolerability, treatment effect, and various PK/PD endpoints.

Arms: arm 1: Gemcitabine + Placebo arm 2: PEGPH20+Gemcitabine
Interventions: intervention 1: Gemcitabine intervention 2: PEGPH20 intervention 3: Placebo
Intervention descriptions: intervention 1: 1000 mg/m2 given IV one time a week (Cycle 1: 7 weeks on treatment, 1 week off treatment; Cycle 2+: 3 Weeks on treatment, 1 week off treatment) intervention 2: (Cycle 1: 7 weeks on treatment/1 week off treatment; Cycle 2+: 3 Weeks on treatment/1 week off treatment). Doses start at 1.0 mcg/kg and modified until recommended Phase 2 dose is determined. Treatment continues until occurrence of significant treatment-related toxicity, progressive disease, or discontinuation criteria are met intervention 3: (Cycle 1: 7 weeks on treatment/1 week off treatment; Cycle 2+: 3 Weeks on treatment/1 week off treatment).

Protocol documents:
Clinical trial NCT01456897
Conditions: Schizophrenia
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2011-10-01; Completion date: 2015-05-01
Enrollment: 282 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To investigate the safety and efficacy of long-term administration of OPC-34712 in patients with schizophrenia.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: OPC-34712
Intervention descriptions: intervention 1: orally administered once daily

Protocol documents: