ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01741701
Conditions: Parkinson's Disease
Sponsor: University of Kansas Medical Center
Start date: 2012-12-01; Completion date: 2014-10-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if Oxaloacetate (OAA) is a safe and effective treatment for Parkinson's disease. Each subject will be asked to make 3 study visits and complete two safety follow-up phone calls over a 4 month period.

Detailed description:

Arms: arm 1: active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily arm 2: placebo capsules that contain only 100 mg ascorbate, taken daily
Interventions: intervention 1: Oxaloacetate (OAA) intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01783470
Conditions: Obesity
Keywords: adipose tissue, brown obesity Adrenergic beta-3 Receptor Agonists thermogenesis metabolism
Sponsor: Aaron Cypess
Start date: 2013-02-01; Completion date: 2014-10-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will test the hypothesis that human brown adipose tissue (BAT) can be activated using a β3-adrenergic receptor (AR) agonist. The efficacy of β3-AR agonist will be compared with cold exposure, which we have already shown can activate human BAT, as well as a placebo control.

Detailed description:
This study will include an outpatient screening visit and three separate, independent overnight study visits in the General Clinical Research Center (GCRC) at Beth Israel Deaconess Medical Center (BIDMC). Screening procedures will consist of a medical history, physical examination, blood draw, and ECG. If, from the screening tests, it is determined that the eligibility criteria have been meet, healthy volunteers will participate in three separate inpatient visits at BIDMC. Study procedures will occur in the GCRC and the Nuclear Medicine suite at BIDMC.

Volunteers will first complete Day A, in which we will measure BAT volume and activity during cold exposure. Cold exposure will consist of wearing a cooling vest at 55 - 61°F, a temperature shown to be cool enough to activate brown adipose tissue but warm enough not to lead to shivering. Resting metabolic rate (RMR) will be measured by indirect calorimetry before and during cool exposure.

If there is detectable brown fat activity on Day A, volunteers will participate in Days B and C. Days B and C will be conducted in random order to reduce any bias from the sequence of treatment and scans, as well as any potential placebo effects. Day B will consist of pharmacological stimulation with β3-AR agonist. On Day C, volunteers will be given a placebo control and will not undergo cooling.

A blood draw of 26 cc will always be done prior to FDG injection and FDG PET/CT will always be performed 60 minutes after FDG injection. On Day A, FDG will be injected after 60 minutes of cool exposure and the volunteer will remain in the cooling vest for another 60 minutes after FDG injection.

To compare energy expenditure and BAT mass and activity among volunteers, we will normalize the data to fat and muscle mass. Whole-body and regional fat and muscle mass will be measured via a Dual Energy X-ray Absorptiometry (DXA) scan at the end of Day A.

Arms: arm 1: single dose. Each subject was randomized to receive placebo at one visit and then the beta3-adrenergic receptor agonist on another study day.
Interventions: intervention 1: beta3-adrenergic receptor agonist
Intervention descriptions: intervention 1: single dose. The subjects were randomized to receive placebo on one study day and active beta3-adrenergic receptor agonist on the other study day.

Protocol documents:
Clinical trial NCT01804946
Conditions: Influenza
Sponsor: Materia Medica Holding
Start date: 2011-02-01; Completion date: 2014-10-01
Enrollment: 161 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is:

* to assess clinical efficiency of Ergoferon for treatment of influenza
* to assess safety of Ergoferon for treatment of influenza
* to compare efficiency of Ergoferon and Tamiflu for treatment of influenza

Detailed description:

Arms: arm 1: 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet TID. arm 2: Oseltamivir for 5 days (75 mg b.i.d.).
Interventions: intervention 1: Ergoferon intervention 2: Oseltamivir
Intervention descriptions: intervention 1: Safety and Efficiency of Ergoferon in treatment of Influenza intervention 2: Safety and Efficiency in treatment of Influenza

Protocol documents:
Clinical trial NCT01805791
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis, UC Patients active mild moderate
Sponsor: Hutchison Medipharma Limited
Start date: 2013-03-01; Completion date: 2014-10-01
Enrollment: 201 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A placebo controlled study of two doses of HMPL-004 in patients with active mild to moderate ulcerative colitis (UC), with a modified Mayo Score 4-10 and an endoscopy subscore of 2-3, taking mesalamine (or equivalent) as a concomitant medication.

The objective is to evaluate the efficacy and safety of HMPL-004 with mesalamine (mesalamine treatment failures). Efficacy will be measured by a comparison of the proportion of patients in each treatment group attaining clinical remission at Week 8 as compared to placebo.

Detailed description:
This Phase III study of HMPL-004 was to enroll approximately 420 subjects with active mild to moderate ulcerative colitis (UC; modified Mayo Score 4-10 and endoscopy score of 2-3). The trial included male and female subjects aged 18 or older. Subjects were currently receiving ≥2.4 g/day mesalamine or equivalent, provided they had taken 5-aminosalicylate (ASA; i.e., mesalamine) at a dose ≥2.4 g/day for at least 6 weeks prior to randomization and were on a stable dosage for at least 2 weeks prior to entering the screening phase of the study.

Qualifying subjects who entered into this study received 3 daily doses of oral HMPL 004 tablets or placebo for 56 days (8 weeks). There were 3 arms in this study consisting of placebo, HMPL-004 600 mg three times a day (TID) or 800 mg TID. Approximately 420 subjects were to be randomized 1:1:1 to one of these 3 arms, stratified by country/region in up to 150 clinical centers in North America, Europe, and Asia.

Arms: arm 1: Placebo, oral tablets, three times a day arm 2: 1 600 mg HMPL-004 tablet, 2x400 mg placebo tablets taken 3 times a day arm 3: 2 x 400 mg HMPL tablets, 1 x 600 mg placebo tablet, taken 3 times per day
Interventions: intervention 1: HMPL-004 1800 mg/day intervention 2: Placebo intervention 3: HMPL-004 2400 mg/day
Intervention descriptions: intervention 1: Subjects randomized to the arm of HMPL-004 1800 mg/day will receive HMPL-004 600 mg TID (total dose 1800 mg/day) for 56 days (8 weeks). intervention 2: Subjects randomized to the arm of Placebo will receive matching Placebo three times daily for 56 days (8 weeks). intervention 3: Subjects randomized to the arm of HMPL-004 2400 mg/day will receive HMPL-004 800 mg TID (total dose 2400 mg/day) for 56 days (8 weeks).

Protocol documents:
Clinical trial NCT01809106
Conditions: Cancer Cancer Pain
Keywords: cancer pain major opioid analgesics
Sponsor: Mario Negri Institute for Pharmacological Research
Start date: 2011-04-01; Completion date: 2014-10-01
Enrollment: 518 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Pain, in neoplastic disease, is a symptom with severe negative impact on the quality of life of patients and a high incidence, with values around 70-90% in advanced and metastatic stages. Than 20 years the main reference for the pharmacological treatment of cancer pain are the guidelines produced by the World Health Organization (WHO). This document shows that the use of opioid drugs is the mainstay of treatment, with particular reference to opioids "major" (3 rd step of the analgesic ladder). The 4 opioids more most commonly prescribed in Italy (oral morphine and oxycodone, fentanyl and buprenorphine transdermal), based on the data currently available, have an analgesic effect would partly overlap but with different percentages of non-responders (NR), a different need to increase the dose over time to maintain adequate analgesia, a different action to the switch to another molecule for ineffectiveness analgesic. The observations described suggest that opioids, although they belong to the same family drug may not be fully comparable with regard to the clinical effects products. Important differences are known on the pharmacokinetic and pharmacodynamic and, more recently, also in terms of pharmacogenomics. This is a comparative study of analgesic strategies based on the use of the 4 mentioned opioids, going to look for possible differences in terms of analgesic efficacy, changes in dose over time, use of switch or permanent abandonment of treatment, parallel to the contour of the side effects. The associated sub-project will link the structure gene of patients and clinical results have emerged.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Morphine intervention 2: Fentanyl intervention 3: Buprenorphine intervention 4: Oxycodone
Intervention descriptions: intervention 1: 60 mg /24 ore intervention 2: 25 microg/h intervention 3: 35 microg/h intervention 4: 40 mg /24 ore

Protocol documents:
Clinical trial NCT01817855
Conditions: COPD Healthy Subjects
Keywords: Phase 1, Safety, Tolerability, Healthy, COPD patients
Sponsor: AstraZeneca
Start date: 2013-09-01; Completion date: 2014-10-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of AZD7624 in healthy subjects and patients with chronic obstructive pulmonary disease.

Detailed description:
A Phase I, Randomized, DoubleBlind Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Inhaled Doses (MAD) of AZD7624 to Healthy Subjects and Patients with COPD

Arms: arm 1: Groups 1-4 multiple ascending doses of AZD7624 Healthy subjects will participate in groups 1-3. In each group 6 subjects will receive AZD7624 and 2 will receive matching placebo.

COPD patients will participate in group 4. In this group, 8 patients will receive AZD7624 and 2 patients will receive matching placebo. arm 2: Groups 1-4 multiple ascending doses of placebo Healthy subjects will participate in groups 1-3. In each group 6 subjects will receive AZD7624 and 2 will receive matching placebo.

COPD patients will participate in group 4. In this group, 8 patients will receive AZD7624 and 2 will receive matching placebo.
Interventions: intervention 1: AZD7624 intervention 2: Placebo to match
Intervention descriptions: intervention 1: Multiple ascending doses (starting from 300 µg lung deposited dose up to 1200 µg) inhaled IMP via a nebulizer intervention 2: Multiple doses inhaled placebo via a nebulizer

Protocol documents:
Clinical trial NCT01830127
Conditions: Hepatitis C, Chronic
Sponsor: Boehringer Ingelheim
Start date: 2013-04-01; Completion date: 2014-10-01
Enrollment: 35 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the pharmacokenetic characteristics of 600 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with mild hepatic impairment (CPA) (Arm 1) versus 400 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with moderate hepatic impairment (CPB) (Arm 2).

Detailed description:

Arms: arm 1: Cohort A CPA BI 207127/QD Faldaprevir Ribavirin arm 2: Cohort B CPB BI 207127/QD Faldaprevir Ribavirin
Interventions: intervention 1: Ribavirin intervention 2: BI 207127 high dose intervention 3: Faldaprevir intervention 4: Ribavirin intervention 5: BI 207127 low dose intervention 6: Faldaprevir
Intervention descriptions: intervention 1: 24 Weeks intervention 2: 24 Weeks intervention 3: 24 Weeks intervention 4: 24 Weeks intervention 5: 24 Weeks intervention 6: 24 Weeks

Protocol documents:
Clinical trial NCT01863680
Conditions: Luteal Hormone Supplementation in In-vitro Fertilization Embryo Transfer
Keywords: Infertility COL-1620 progesterone gel Fertilization in Vitro Embryo Transfer
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2013-07-01; Completion date: 2014-10-01
Enrollment: 178 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this trial is to demonstrate the non-inferiority of the clinical pregnancy rate per embryo transfer to the historical standard value in in-vitro fertilization (IVF)/embryo transfer (ET) cycles in Japan (Japan Society of Obstetrics and Gynecology \[JSOG\] 2009 registry data: 24.3 percent \[%\]). The secondary objectives of this trial are to assess the biochemical pregnancy rate per ET, pharmacokinetics, and safety of COL-1620.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: COL-1620 intervention 2: Gonadotropin-releasing hormone (GnRH) analogue intervention 3: Follicle-stimulating hormone (FSH) intervention 4: Human Chorionic Gonadotropin (hCG)
Intervention descriptions: intervention 1: The subjects will be administered with COL-1620 vaginal progesterone gel (1.125 grams of progesterone gel containing 90 milligram that is 8 percent \[%\] gel) vaginally once daily, from the day of ovum pick-up (OPU) until Week 12. intervention 2: Subjects will undergo conventional controlled ovarian stimulation (COS) therapy for in-vitro Fertilization and Embryo Transfer (IVF/ET) according to the Investigator's discretion using GnRH analogue (agonist or antagonist) preparation. intervention 3: Subjects will undergo conventional COS therapy for IVF/ET according to the Investigator's discretion using FSH containing preparation. intervention 4: Subjects will undergo conventional COS therapy for IVF/ET according to the Investigator's discretion using hCG preparation.

Protocol documents:
Clinical trial NCT01868243
Conditions: Primary Disease
Keywords: Atrial Fibrillation Bioprosthesis Stroke Dabigatran Warfarin
Sponsor: Hospital Ana Nery
Start date: 2013-08-01; Completion date: 2014-10-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
DAWA is a phase 2, prospective, open-label, randomized, pilot study. The main variable to be observed in this study is intracardiac thrombus. There are no formal primary or secondary clinical efﬁcacy or safety outcomes because it is a pilot study.

Detailed description:
Mortality and morbidity events (reversible ischemic neurological deficit, ischemic and hemorrhagic stroke, systemic embolism, any bleeding, prosthesis valve thrombosis and death) were evaluated in an exploratory manner. The details of the trial design have been previously described.8 The trial protocol was approved by the local ethics and research committee in the city of Salvador-Brazil, and written informed consent was obtained from all patients. An independent data and safety monitoring board closely monitored the trial. All the members contributed to the interpretation of the results, wrote the first version of the manuscript and approved all versions, made the decision to submit the manuscript for publication, and vouch for the accuracy and completeness of the data reported and the fidelity of this article to the study protocol.

Patients eligible for inclusion in the study were 18 to 64 years old, underwent mitral and/or aortic bioprosthesis valve replacement at least 3 months prior to entering the study and had documented AF postoperatively in addition to exclusion of atrial thrombus or valve prosthesis thrombosis by transesophageal echocardiography (TEE). Non-contrast brain computed tomography (CT) without hemorrhage or findings of acute cerebral infarction on the last 2 days of screening was also necessary.

Patients were randomly assigned to receive dabigatran or warfarin by a computer generated list of random numbers performed to 1:1 ratio between the groups. Following that, the allocation sequence was concealed from the researcher enrolling participants in sequentially numbered, opaque, black, sealed envelopes. After randomization, patients had study visits scheduled at 7 days (via telephone) and at 30 days (personally) with a monthly follow-up for 90 days. After this, non-contrast brain CT and TEE were repeated. The former was executed to document possible cerebral events with no clinical expression and the latter to analyze the incidence of intracardiac thrombi, new dense spontaneous echo contrast (SEC) or its resolution, in addition to thrombosis or dysfunction of valvular prosthesis.

Arms: arm 1: Dabigatran 110 mg BID arm 2: Warfarin adjusted-dose
Interventions: intervention 1: Dabigatran intervention 2: Warfarin
Intervention descriptions: intervention 1: Group 1 - Dabigatran 110 mg (50 patients) intervention 2: Warfarin adjusted-dose

Protocol documents:
Clinical trial NCT01881126
Conditions: Glaucoma Ocular Hypertension
Sponsor: Allergan
Start date: 2013-06-01; Completion date: 2014-10-01
Enrollment: 93 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This efficacy and safety study will evaluate LUMIGAN® RC/ LUMIGAN® .01 (bimatoprost 0.01%) alone compared to TRAVATAN Z® (travoprost 0.004%) and TIMOLOL MALEATE-EX, 0.5%/TIMOLOL GFS 0.5% (timolol 0.5% ophthalmic gel forming solution) in patients who require IOP lowering therapy.

Detailed description:

Arms: arm 1: Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks. arm 2: Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
Interventions: intervention 1: bimatoprost 0.01% intervention 2: travatan 0.004% intervention 3: timolol 0.5% intervention 4: hypromellose 0.3%
Intervention descriptions: intervention 1: Bimatoprost 0.01% administered to both eyes once daily for 12 weeks. intervention 2: Travatan 0.004% administered to both eyes once daily for 12 weeks. intervention 3: Timolol 0.5% administered to both eyes once daily for 12 weeks. intervention 4: Hypromellose 0.3% lubricant eye drops (for masking purposes) administered to both eyes once daily for 12 weeks.

Protocol documents:
Clinical trial NCT01886287
Conditions: Neuroendocrine Carcinoma
Keywords: endocrine system neuroendocrine tumors neuroendocrine cancer metastatic neuroendocrine gastrointestinal (GI) high-dose octreotide flushing diarrhea quality of life in patients disease-related symptoms
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2013-12-01; Completion date: 2014-10-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of the study is to investigate the effects of high-dose octreotide on flushing, diarrhea, and quality of life in patients whose disease-related symptoms are inadequately controlled by the maximum approved dose of octreotide LAR.

Detailed description:
The study population will consist of patients with advanced (metastatic or unresectable) neuroendocrine tumors with suboptimally controlled carcinoid syndrome. While the majority of patients will have primary tumors of the ileocecum (midgut), any serotonin-producing neuroendocrine tumors will be eligible (including pancreatic, lung and unknown primary).

All patients will be followed for adverse events and serious adverse events for 28 days following the last dose of above-label octreotide, or until resolution or stabilization of the event, whichever comes first.

Arms: arm 1: Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.
Interventions: intervention 1: Octreotide LAR
Intervention descriptions: intervention 1: Octreotide LAR as outlined in Treatment Arm.

Protocol documents:
Clinical trial NCT01888965
Conditions: Colorectal Cancer Pancreas Cancer
Keywords: Maintenance therapy Adjuvant Therapy
Sponsor: Georgetown University
Start date: 2013-10-01; Completion date: 2014-10-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is for patients with stage 4 colon cancer who have had initial chemotherapy or had surgery to remove metastases and patients with pancreas cancer, which has been surgically removed and are receiving adjuvant chemotherapy or is locally advanced and have already received chemotherapy and radiation.

The purpose of this study is to determine the effects of oral dovitinib in patients with advanced stage colorectal and pancreas. Effects include biomarker changes, progression-free survival and safety. Dovitinib will be taken by mouth for 5 days out of every week for up to 2 years.

Detailed description:
This is a single institution, nonrandomized, open-label pilot study of dovitinib as maintenance and adjuvant therapy in patients with colorectal and pancreas cancers.

Patient Populations:

Cohort 1: Stage 4 Colon Cancer s/p metastasectomy (Adjuvant cohort)

Cohort 2: Stage 4 Colon Cancer after initial chemotherapy (Maintenance cohort)

Cohort 3: Pancreas Cancer s/p resection and adjuvant chemo (Adjuvant cohort)

Cohort 4: Locally advanced pancreas cancer s/p chemo and radiation (Maintenance cohort)

Each of the 4 cohorts will be accrued independently. 15 patients will be accrued to each cohort. Treatment will begin following the completion of the standard adjuvant or induction therapy. Patients will continue to take dovitinib until they demonstrate progression of disease using standard RECIST criteria, withdraw consent, or experience unacceptable toxicity.

Blood and urine Biomarker studies will be performed on all patients in all cohorts. Samples will be collected at baseline and every 8 weeks for the first 6 months and then every 3 months thereafter, while patients are on study. Blood and urine will be collected and banked for protein, miRNA and metabolomic analysis. Tumor specimens will be taken from patients in maintenance cohorts before and 2 weeks after initiation of dovitinib. All of these samples will be analyzed to determine if biomarkers of benefit and progression can be determined.

Arms: arm 1: Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years
Interventions: intervention 1: Dovitinib
Intervention descriptions: intervention 1: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years.

If 500 mg is intolerable, 400 mg will be dosed. If 400 mg is intolerable, 300 mg will be dosed

Protocol documents:
Clinical trial NCT01893346
Conditions: Systemic Infections
Keywords: Ceftazidime, Avibactam, Anti-Infectives
Sponsor: Pfizer
Start date: 2013-07-01; Completion date: 2014-10-01
Enrollment: 35 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To assess the pharmacokinetics, safety and tolerability of a single dose of CAZ-AVI in children from 3 months of age to \<18 years.

Detailed description:
This is a phase I, open-label, single-dose study. The study aims to characterize the pharmacokinetics of CAZ-AVI and assess its safety and tolerability following a single IV dose given to hospitalized pediatric patients receiving systemic antibiotic therapy for suspected or confirmed infection. This study will include 4 cohorts, each consisting of at least 8 evaluable pediatric patients, aged ≥3 months to \<18 years, who are hospitalized with infections.

Arms: arm 1: This arm will include 4 cohorts. Patients will be stratified by age.
Interventions: intervention 1: CAZ-AVI
Intervention descriptions: intervention 1: Single IV dose of Ceftazidime and Avibactam. Dosage regimen will vary depending on cohort.

Protocol documents: