ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02324569
Conditions: Type 2 Diabetes Mellitus
Keywords: Pharmacological therapy
Sponsor: Takeda
Start date: 2014-12-27; Completion date: 2016-12-28
Enrollment: 240 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purposes of this study is to evaluate the efficacy and safety of SYR-472 when administered at a dose of 100 mg once weekly as an add-on to insulin therapy compared with placebo in patients with type 2 diabetes mellitus and inadequate glycemic control despite treatment with insulin preparations in addition to diet and/or exercise therapy; and to evaluate the long-term efficacy and safety of SYR-472 when administered at a dose of 100 mg once weekly as an add-on to insulin therapy in patients with type 2 diabetes mellitus and inadequate glycemic control despite treatment with insulin preparations in addition to diet and/or exercise therapy.

Detailed description:
This is a phase 4, multicenter, randomized, double-blind, parallel-group, comparative study using placebo (Treatment Period I) and a phase 4, multicenter, open-label, long-term study (Treatment Period II) to evaluate the efficacy and safety of SYR-472 when administered at a dose of 100 mg as an add-on to insulin therapy in patients with type 2 diabetes mellitus and inadequate glycemic control despite treatment with insulin preparations in addition to diet and/or exercise therapy.

Arms: arm 1: One tablet of SYR-472 100 mg orally once weekly before breakfast arm 2: One tablet of SYR-472 100 mg orally or one placebo tablet orally once weekly before breakfast
Interventions: intervention 1: SYR-472 intervention 2: Placebo
Intervention descriptions: intervention 1: SYR-472 tablets intervention 2: Placebo tablets

Protocol documents:
Clinical trial NCT02609659
Conditions: Hepatitis C Virus (HCV)
Keywords: Chronic Hepatitis C Infection
Sponsor: AbbVie
Start date: 2015-10-28; Completion date: 2016-12-28
Enrollment: 105 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study seeks to assess the safety and efficacy of treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir with low-dose ribavirin in non-cirrhotic, genotype 1a (GT1a) hepatitis C virus infected participants who are treatment-naïve or treatment-experienced with Interferon (IFN) or Pegylated Interferon (pegIFN) with or without Ribavirin (RBV).

Detailed description:

Arms: arm 1: 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) plus RBV (ribavirin \[600 mg once daily\]) for 12 weeks.
Interventions: intervention 1: ombitasvir/paritaprevir/ritonavir and dasabuvir intervention 2: ribavirin
Intervention descriptions: intervention 1: Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet intervention 2: Tablet

Protocol documents:
Clinical trial NCT01966419
Conditions: Acute Episode of Overt Hepatic Encephalopathy Hepatic Encephalopathy
Keywords: hepatic encephalopathy hyperammonemia cirrhosis ornithine phenylacetate OCR-002
Sponsor: Ocera Therapeutics, Inc.
Start date: 2014-01-07; Completion date: 2016-12-29
Enrollment: 231 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether ornithine phenylacetate can speed recovery from an acute hepatic encephalopathy episode requiring hospitalization in cirrhotic patients.

Detailed description:
The primary objectives of the study were to evaluate the efficacy of OCR-002 for treatment of an acute hepatic encephalopathy (HE) episode in cirrhotic patients requiring hospitalization and the safety and tolerability of OCR-002 in hospitalized cirrhotic patients with an acute episode of HE.

Arms: arm 1: Participants receive ornithine phenylacetate for up to 5 days via continuous IV infusion in addition to standard of care (SOC) arm 2: Participants receive matching placebo up to 5 days via continuous IV infusion in addition to SOC
Interventions: intervention 1: ornithine phenylacetate intervention 2: placebo intravenous infusion
Intervention descriptions: intervention 1: Ornithine phenylacetate for continuous IV infusion at dose levels predicated on level of hepatic decompensation intervention 2: Placebo for continuous IV infusion that is visually identical to the experimental product

Protocol documents:
Clinical trial NCT02403895
Conditions: Squamous Non Small Cell Lung Cancer
Sponsor: AstraZeneca
Start date: 2015-04-15; Completion date: 2016-12-29
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Open--label, phase 2a, multi-centre, single-arm study to assess the efficacy and safety of AZD2014 and weekly paclitaxel in patients with squamous non-small cell lung cancer (NSCLC)

Detailed description:
This is an open-label, phase 2a, multi-centre, single-arm study to assess the efficacy and safety of the combination of AZD2014 and weekly paclitaxel in patients with squamous non-small cell lung cancer (NSCLC) that is relapsed or refractory to conventional treatment after at least 1 prior treatment with standard of care (SOC) and for whom weekly paclitaxel treatment is an appropriate treatment choice.

The study will simultaneously enrol patients to the following two groups. Group A (intensive PK) will enrol 10 evaluable patients for an intra-patient evaluation of the impact of paclitaxel on exposure to AZD2014, and the impact of AZD2014 on exposure to paclitaxel via intensive PK sampling and non-compartmental PK analysis techniques (NCA). Group B (sparse PK) will enrol 30 patients and sparse sampling and population PK modelling techniques will be employed to estimate exposure to AZD2014 when administered in combination with a weekly paclitaxel dosing regimen. The efficacy and safety of the AZD2014 and weekly paclitaxel combination will be evaluated in all 40 patients using RECIST 1.1, observation of AEs/SAEs and use of conventional safety parameters.

Eligible patients will receive study treatment consisting of a single weekly paclitaxel infusion (80 mg/m2) on Day 1 of each week and twice daily (BD) 50 mg doses of AZD2014 on the first 3 days each week for 6 weeks \[except Group A patients in Week 1 of Cycle 1 who will take 50 mg BD doses of AZD2014 on Days 3, 4 and 5 (or Days 4, 5 and 6) to accommodate PK sampling\], followed by a break from treatment when no paclitaxel or AZD2014 will be given. This 7-week schedule composes one cycle of treatment. AZD2014 will be administered as oral tablets to fasted patients (i.e., no food 2 hours before and 1 hour after each dose). Patients will receive up to 6 cycles of paclitaxel, although additional cycles of paclitaxel may be given if deemed appropriate by the Investigator.

Arms: arm 1: Open-label AZD2014 given twice daily 3 days on, 4 days off during weekly paclitaxel
Interventions: intervention 1: Open-label AZD2014 intervention 2: paclitaxel
Intervention descriptions: intervention 1: Dual TORC1/TORC2 inhibitor intervention 2: Taxane

Protocol documents:
Clinical trial NCT01663740
Conditions: Cytomegalovirus Infections
Sponsor: Hoffmann-La Roche
Start date: 2012-01-30; Completion date: 2016-12-30
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: 

Brief summary:
This observational study will compare spermatogenesis in male adult renal transplant recipients receiving valganciclovir versus untreated matched controls. Data will be collected from each participant for up to 52 weeks post transplant.

Detailed description:

Arms: arm 1: Participants with donor positive (D+)/recipient negative (R-) cytomegalovirus (CMV) serology, who receive valganciclovir prophylaxis according to the local prescribing information, will be observed for spermatogenesis up to 52 weeks post-transplant. arm 2: Participants with donor negative (D-)/R- CMV serology, who do not receive prophylaxis, will be observed for spermatogenesis up to 52 weeks post-transplant.
Interventions: intervention 1: Valganciclovir
Intervention descriptions: intervention 1: Participants will receive valganciclovir 900 milligrams (mg) orally once daily for up to a maximum of 200 days post-transplant.

Protocol documents:
Clinical trial NCT01310036
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2011-04-30; Completion date: 2016-12-30
Enrollment: 208 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, single arm study will evaluate the safety and efficacy of Tarceva (erlotinib) as first-line therapy in participants with stage IV or recurrent non-small cell lung cancer who harbour epidermal growth factor receptor (EGFR) mutations. All participants will receive Tarceva 150 mg daily orally until disease progression or unacceptable toxicity occurs. At the investigator's discretion, participants may receive Tarceva beyond disease progression.

Detailed description:

Arms: arm 1: Erlotinib 150 mg daily
Interventions: intervention 1: Erlotinib
Intervention descriptions: intervention 1: Erlotinib 150 mg was administered orally daily until disease progression or unacceptable toxicity.

Protocol documents:
Clinical trial NCT02647944
Conditions: Obesity
Sponsor: Mayo Clinic
Start date: 2015-12-18; Completion date: 2016-12-30
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
This study was being done to assess the stomach emptying effect of a maximum dose of 3 mg Liraglutide compared to placebo in subjects who are overweight or obese. Liraglutide is a medication approved by the Food and Drug Administration (FDA) for routine clinical use.

Detailed description:
The objective of this study was to compare effects of liraglutide and placebo over 16 weeks on gastric motor functions, satiation, satiety and weight in obese patients. Subjects were randomized to liraglutide or placebo. Liraglutide or placebo was escalated by 0.6mg/day each week for 5 weeks and continued until week 16. At baseline and after 16 weeks' treatment, the investigators measured weight, gastric emptying of solids (GES), gastric volumes, satiation (maximum tolerated volume of liquid nutrient drink), and satiety. GES was also measured at 5 weeks.

During the study, the subjects received standardized dietetic and behavioral advice for weight reduction therapy. All subjects were given a standard text for information and met with a behavioral psychologist who has expertise in obesity treatment at the baseline visit and at visits at weeks 4,8, and 12. Additionally, the subjects had brief contact with a member of the study team every 4 weeks to inquire about their adherence to study protocol, any difficulties they were experiencing, whether they were reading their text assignments, and to answer any additional questions.

Arms: arm 1: Saxenda initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication. arm 2: Placebo initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
Interventions: intervention 1: Liraglutide intervention 2: Placebo
Intervention descriptions: intervention 1: Initiate at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6mg/day in weekly intervals to a dose of 3.0 mg/day is achieved (\~4 weeks). Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication. intervention 2: None

Protocol documents:
Clinical trial NCT02730819
Conditions: Melasma
Sponsor: Mayo Clinic
Start date: 2016-05-15; Completion date: 2016-12-30
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to gather information on the effectiveness and tolerability of a novel composition of existing U.S. Food and Drug Administration (FDA) approved topical medications for the treatment of moderate to severe melasma.

Detailed description:
Subjects with moderate to severe melasma will apply 0.5 grams (pea-sized) amount of Illuminate Cream topically to affected areas for 20 weeks. The change in Melasma Area and Severity Index (MASI) score will be evaluated a baseline and Weeks 4, 12, and 20.

The MASI score is a validated test, calculated by subjective assessment of 3 factors: Area (A) of involvement, Darkness (D), and Homogeneity (H), with the forehead, right malar region, left malar region, and chin, corresponding to 30%, 30%, 30% and 10% of the total face, respectively. The area of involvement in each of these 4 areas is given a numeric value of 0 to 6 (0 = no involvement; 1 = \<10%; 2 = 10%-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; and 6 = 90-100%).

Darkness and homogeneity are rated on a scale from 0 to 4 (0 = absent; 1 = slight; 2 = mild; 3 = marked; and 4 = maximum). The score is calculated by adding the sum of the severity ratings for darkness and homogeneity, multiplied by the value of the area of involvement, for each of the 4 facial areas.

Arms: arm 1: Illuminate Cream is a skin-lightening formulation containing multiple drugs, including a retinoid, calcineurin inhibitor, anti-tyrosinase agent and sunscreen microfine zinc oxide. Approximately 0.5 grams to be applied topically to affected areas of skin once per day for 20 weeks.
Interventions: intervention 1: Illuminate Cream
Intervention descriptions: intervention 1: Topical compound applied daily

Protocol documents:
Clinical trial NCT00680797
Conditions: Aging Insulin Resistance
Keywords: Aging Hormones Insulin resistance
Sponsor: VA Office of Research and Development
Start date: 2005-01-01; Completion date: 2016-12-31
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this research study is to study the effect of testosterone or estrogen on blood sugar control and fat metabolism. Changes in hormone levels with age may affect risk factors for heart disease such as diabetes. Diabetes is a glandular condition associated with lack of the hormone insulin or an insensitivity to it resulting in problems with blood sugar control and fat metabolism. The effect of commonly used hormonal supplements such as testosterone by older adults on insulin and body composition is not well understood. In this study, the role of testosterone and estrogen on your ability to control blood sugar and your body composition will be assessed.

The investigators plan to study 60 subjects. All of these subjects will be healthy older men between the ages of 60-85 years old who are not on testosterone therapy. Subjects that are screened who have any clinically significant abnormalities detected on their screening physical exam or laboratory testing (e.g. Prostate Specific Antigen \> 4), who have a history of prostate cancer, polycythemia, or who cannot take testosterone will not be included.

If a subject is eligible to participate after initial screening, that subject will take medications to adjust their hormone levels and have tests performed that measure insulin sensitivity and adiposity before and after these hormone medications. The outcomes that will be measured are: 1) insulin sensitivity, 2) hormone levels (total and free testosterone levels, sex hormone-binding globulin levels) and 3) body composition and abdominal adiposity.

Detailed description:

Arms: arm 1: +Testosterone, +Estrogen arm 2: +Testosterone, -Estrogen arm 3: -Testosterone, +Estrogen arm 4: -Testosterone, -Estrogen
Interventions: intervention 1: Testosterone intervention 2: Estrogen
Intervention descriptions: intervention 1: Testosterone gel intervention 2: Estrogen patch

Protocol documents:
Clinical trial NCT01755091
Conditions: Sleep Apnea, Obstructive
Sponsor: University of Illinois at Chicago
Start date: 2013-02-01; Completion date: 2016-12-31
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a proof of concept study to determine the safety and efficacy of dronabinol for the treatment of obstructive sleep apnea syndrome (OSA).

Detailed description:

Arms: arm 1: Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in arm 2: Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in arm 3: Dronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation
Interventions: intervention 1: Dronabinol intervention 2: Placebo (for Dronabinol)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01971853
Conditions: Pain
Keywords: Analgesia
Sponsor: University of Colorado, Denver
Start date: 2013-10-01; Completion date: 2016-12-31
Enrollment: 88 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
All healthcare providers strive continually to improve the outcome of their treatment approaches. The investigators hypothesize that preventive analgesics administered before a child is sedated with a Demerol-Vistaril regimen will improve the outcome of a sedation.

Detailed description:
To increase outcomes for patients receiving dental sedation by providing significant evidence that the new regimen improves the quality of sedation and results in an improved post sedation ability to eat, drink, resume normal activities and require less additional pain medications.

Arms: arm 1: an Ibuprofen and Acetaminophen Placebo will be added to a Demerol-Vistaril regimen arm 2: 5 mg/kg ibuprofen + 15 mg/kg acetaminophen will be added to a Demerol-Vistaril regimen
Interventions: intervention 1: oral placebo intervention 2: Oral Analgesics
Intervention descriptions: intervention 1: Ibuprofen placebo and Acetaminophen placebo will be added to a Demerol-Vistaril regimen intervention 2: Ibuprofen at 5.0 mg/kg and Acetaminophen at 15.0 mg/kg will be added to a Demerol-Vistaril regimen

Protocol documents:
Clinical trial NCT02067104
Conditions: Basal Cell Carcinomas
Sponsor: University of Arizona
Start date: 2014-02-17; Completion date: 2016-12-31
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a single site double blinded Phase II study to evaluate the chemopreventative effectiveness of vismodegib in the treatment of subjects at high risk for developing basal cell carcinomas (BCC).

Detailed description:
The primary objective of this study will be to determine if vismodegib pulse therapy will significantly reduce the incidence of newly diagnosed basal cell carcinomas (BCC) in high risk individuals when compared with placebo, as measured by the incidence of biopsy confirmed BCC over a 24 month period.

The secondary objective will be to determine that there will be no difference in the incidence of newly diagnosed squamous cell carcinomas (SCC) in the same subjects receiving vismodegib treatment when compared with placebo, as measured by the incidence of biopsy confirmed SCC over the same 24 month period.

Arms: arm 1: receive 150 mg of oral placebo daily for a period of 2 months arm 2: receive 150 mg of vismodegib daily for a period of 2 months
Interventions: intervention 1: Vismodegib intervention 2: Placebo
Intervention descriptions: intervention 1: Pulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months. intervention 2: Pulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months.

Protocol documents:
Clinical trial NCT02263365
Conditions: Dehydration, Diverting Ileostomy, Loperamide
Sponsor: Cedars-Sinai Medical Center
Start date: 2014-10-07; Completion date: 2016-12-31
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Dehydration post creation of a diverting ileostomy is a common and debilitating problem faced by patients undergoing ileal-anal pouch anastomoses for both inflammatory bowel disease and familial adenomatous polyposis (FAP) syndrome. Those patients with low rectal cancers or other polyposis syndromes e.g. HNPCC hereditary non polyposis colorectal cancers, may potentially have a delay in the adjuvant therapy when faced with this complication.

Studies performed in this groups of patients report a readmission rate of 17-21% for dehydration.

Loperamide has been shown to significantly decrease the daily volume of weight of stool in these patients.

The purpose of this study is to establish whether loperamide given at 4mg three times daily for 14 days from day of discharge empirically decreases 30 days readmission rate for dehydration.

The investigators hypothesize that there will be a 15% decrease from 25% to 10% in the readmission rates, that severity of dehydration will be decreased.

Detailed description:

Arms: arm 1: None arm 2: Patients randomized to this arm will be administered 4mg tid (three times daily) of loperamide from the day of discharge onwards. A total of duration of 14 days of medication will be administered
Interventions: intervention 1: Loperamide
Intervention descriptions: intervention 1: Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge

Protocol documents: