ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01036321
Conditions: Prostate Cancer
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2009-12-11; Completion date: 2018-04-16
Enrollment: 71 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of our study is to recruit and treat 96 men diagnosed with prostate cancer and scheduled for a prostatectomy with a capsule form of either purified isoflavones or placebo for a 3-6 week period to see if we can slow down the rate of prostate cancer growth. A placebo is a pill or something that looks like the medicine that is being studied but has no active medicine in it. We also want to see if taking purified isoflavones is safe and if it reduces lower urinary tract symptoms. In addition, we want to study if purified isoflavones are able to slow the progression of prostate cancer, and the mechanism of action of purified isoflavones. If the safety and the effects of purified isoflavones on slowing down the progression of prostate cancer is shown in our study, this will also be a safe way of treating men who are at high risk of prostate cancer, so that we can prevent prostate cancer in the future.

Detailed description:
Patients will need to take two (2) capsules daily, one with their breakfast and one with their dinner. On the day prior or the day that patients are coming in for their pre-operative surgery blood work, we ask that they take the second dose with lunch, if their appointment is in the afternoon.

At the start of the study and at the end of the study (3-6 weeks), patients will undergo interviews, complete questionnaires, and have lab tests to determine if this drug is effective to reduce progression of prostate cancer and is safe to use.

Patients will also receive a multivitamin/mineral supplement for the 3-6 weeks that they are on this study and will be required to take one (1) every day. It is required that patients not take any other vitamin/mineral or herbal preparation containing isoflavones and avoid eating or drinking soy products.

We anticipate that most patients will be scheduled for a prostatectomy 3-6 weeks (+/- 3 days) from start of study agent. In addition to their first visit, patients will be required to come in the day of the surgery for prostatectomy.

Arms: arm 1: Soy-based isoflavone concentrate with methyl cellulose blend filler. 40 mg daily. arm 2: Placebo.
Interventions: intervention 1: Purified isoflavones intervention 2: Methyl cellulose blend
Intervention descriptions: intervention 1: Soy-based isoflavone concentrate with methyl cellulose blend filler - Take 2 capsules daily intervention 2: Placebo - Take 2 capsules daily

Protocol documents:
Clinical trial NCT02014441
Conditions: Melanoma
Sponsor: Amgen
Start date: 2014-04-07; Completion date: 2018-04-19
Enrollment: 61 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective was to estimate the proportion of participants with detectable talimogene laherparepvec deoxyribonucleic acid (DNA) in the blood and urine at any time after administration of talimogene laherparepvec within the first 3 cycles.

Detailed description:

Arms: arm 1: Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.

Participants were treated with talimogene laherparepvec until they achieved a complete response (CR), all injectable tumors had disappeared, clinically relevant (resulting in clinical deterioration or requiring change of therapy) disease progression per modified World Health Organization (WHO) response criteria beyond 6 months of therapy, or intolerance of study treatment, whichever occurred first.
Interventions: intervention 1: Talimogene laherparepvec
Intervention descriptions: intervention 1: Talimogene laherparepvec will be administered by intralesion injection at an initial dose of up to 4.0 mL of 10\^6 PFU/mL. The second and subsequent doses will will be up to 4.0 mL 10\^8 PFU/mL. The second dose should be administered 21 days from the initial dose. All subsequent doses should be given every 14 days.

Protocol documents:
Clinical trial NCT03289208
Conditions: Renal Impairment Healthy
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2016-10-27; Completion date: 2018-04-20
Enrollment: 30 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the pharmacokinetics of MCI-186 after a single intravenous infusion of 30mg/hour in subjects with mild or moderate renal impairment compared to subjects with normal renal function.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: MCI-186
Intervention descriptions: intervention 1: 30 mg of edaravone will be administered intravenously over 60 minutes.

Protocol documents:
Prot_000.pdf: 





































































































































SAP_001.pdf:
Clinical trial NCT01888432
Conditions: Liver Transplantation
Keywords: liver transplantation everolimus tacrolimus reduced calcineuron inhibitor renal function living donor RAD001H2307 RAD001H
Sponsor: Novartis Pharmaceuticals
Start date: 2013-09-25; Completion date: 2018-04-21
Enrollment: 285 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial was to demonstrate the efficacy and safety of everolimus in combination with reduced tacrolimus, compared to tacrolimus control, in living donor liver transplant recipients.

Detailed description:
This study was 24 month, multicenter study in 280 living donor liver transplant patients from Asia, Europe and Canada. The study has an long term extension in Japan and approximately 28 patients were to be included to evaluate the long-term efficacy and safety of concentration-controlled everolimus regimen plus reduced tacrolimus compared to standard tacrolimus in recipients of living donor liver transplants in Japan who participated in the CRAD001H2307 study.

Data reported here are the CRAD001H2307 core study results and its extension (CRAD001H2307E1).

Arms: arm 1: Everolimus + reduced tacrolimus ± corticosteroids arm 2: Standard tacrolimus ± corticosteroids
Interventions: intervention 1: Everolimus + reduced tacrolimus intervention 2: Standard tacrolimus
Intervention descriptions: intervention 1: Everolimus was initiated at Week 4 post transplantation. The dose was adjusted to maintain the everolimus trough blood levels between 3-8 ng/mL for the duration of the study. Tacrolimus was reduced to 3-5 ng/mL. intervention 2: Tacrolimus was initiated as soon as possible after transplantation according to approved labeling recommendations. The trough level should've been 5-15 ng/mL until randomization, 8-12 ng/mL from randomization until month 4 and after month 4 until end of study reduced to 6 -10 ng/mL.

Protocol documents:
Clinical trial NCT02262728
Conditions: Hepatitis C, Chronic
Keywords: Hepatitis C, Chronic Simeprevir Daclatasvir Sofosbuvir Decompensated Liver Disease
Sponsor: Janssen Research & Development, LLC
Start date: 2014-09-30; Completion date: 2018-04-25
Enrollment: 40 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy of a 12-week regimen containing simeprevir, daclatasvir and sofosbuvir in participants with decompensated liver disease (the liver function is insufficient) due to genotype 1 or 4 Hepatitis (inflammation of the liver) C virus (HCV) infection by assessing sustained virologic response 12-weeks after the end of study drug treatment (SVR12).

Detailed description:
This is an open-label (all people know which treatment the participants receive) Phase 2 study to investigate the efficacy, safety and pharmacokinetics of simeprevir, daclatasvir and sofosbuvir in treatment-naive (participants have never received HCV treatment with any approved or investigational agent) and treatment - experienced (participants have failed at least one previous course of \[Pegylated\] interferon \[(Peg)IFN\], with or without Ribavirin) participants. Participants will be assigned to 1 of 2 panels: Panel 1 (n=20): Child-Pugh score less than (\<) 7 with evidence of portal hypertension (confirmed by presence of esophageal varices or HVPG greater than or equal to \[\>=\] 10 mm Hg); Panel 2 (n=20): Child-Pugh score 7 to 9 (extremes included). The total study duration for each participant will be approximately 276 weeks. The study will consist of 3 parts: Screening Phase (approximately 4 weeks) and open-label treatment Phase (from Week 4 to 16) and follow-up Phase (until 5 years after the actual end of study drug treatment). Participants will receive simeprevir (150 milligram \[mg\] capsule), daclatasvir (60 mg tablet) and sofosbuvir (400 mg tablet) orally once daily for 12 weeks. Efficacy will be primarily evaluated by percentage of participants with SVR12. Participants' safety will be monitored throughout the study.

Arms: arm 1: Participants with Child-Pugh score \<7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient \[HVPG\] greater than or equal to 10 millimeter of mercury \[mm Hg\]) will receive simeprevir (150 milligram \[mg\] capsule), daclatasvir (60 mg tablet) and sofosbuvir (400 mg tablet) orally once daily for 12 weeks. arm 2: Participants with Child-Pugh score 7 to 9 (extremes included) will receive simeprevir (150 mg capsule), daclatasvir (60 mg tablet) and sofosbuvir (400 mg tablet) orally once daily for 12 weeks.
Interventions: intervention 1: Simeprevir intervention 2: Daclatasvir intervention 3: Sofosbuvir
Intervention descriptions: intervention 1: Simeprevir 150 milligram (mg) capsule orally once daily for 12 weeks intervention 2: Daclatasvir 60 mg tablet orally once daily for 12 weeks intervention 3: Sofosbuvir 400 mg tablet orally once daily for 12 weeks

Protocol documents:
Clinical trial NCT03000309
Conditions: Plaque Psoriasis
Sponsor: Derm Research, PLLC
Start date: 2016-12-29; Completion date: 2018-04-25
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Sixteen week open label study of apremilast in combination with topical steroids with a four week safety follow up visit.

Detailed description:
This is an open label, 16 week study of apremilast in combination with topical corticosteroids (TCS). Twenty qualified subjects will be enrolled. Visits will consist of Baseline, 8 week, 16 week and a 20 week safety follow up after 4 weeks off treatment. Subjects will dose with apremilast as per label. Topical corticosteroids (TCS) will be used for up to Week 4 as per label and then will be used on an as needed basis until Week 16. Assessments will include Static Physicians Global Assessment (sPGA), Psoriasis Area Severity Index (PASI), Psoriatic Body Surface Area (BSA), Dermatology Life Quality Index (DLQI),Assessment of Pruritus, Patient Satisfaction questionnaire. and Patient Global Assessment (PtGA)

Arms: arm 1: Apremilast, 30 mg. tablets, two times a day for 16 weeks
Interventions: intervention 1: Apremilast
Intervention descriptions: intervention 1: None

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT01875367
Conditions: Breast Cancer
Keywords: Subcutaneous trastuzumab Intravenous trastuzumab HER2 positive Advanced Breast Cancer
Sponsor: Spanish Breast Cancer Research Group
Start date: 2013-09-18; Completion date: 2018-04-30
Enrollment: 166 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
GEICAM/2012-07 is a study phase III, prospective, open, randomized, multicenter and national designed to assess patient preference for intravenous (IV) or subcutaneous (SC) of trastuzumab, and within the SC by the administration through the vial or device self-administration in patients with disseminated breast cancer HER2.

Detailed description:
Approximately 195 patients will be included to receive subcutaneous trastuzumab a fixed dose of 600 mg every 3 weeks for 4 cycles (2 administered from the injection of a vial with a syringe and 2 with the injection device). Following administration of these four cycles, the patient will decide whether or not to continue with the subcutaneous formulation of trastuzumab every 3 weeks until progression (out of the study). Since the randomization in the study until the start with subcutaneous trastuzumab, patients will receive a treatment cycle of intravenous trastuzumab as usual.

Main objective: Proportion of patients indicate a preference for the use of subcutaneous vs intravenous trastuzumab.

This principal primary objective will be analyzed with the answers to questionnaire of experiences and preferences of the patients (Principal endpoint) The duration of the study has been estimated after 34 months.

Arms: arm 1: Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with vial (Injectable Solution) x 2 cycles, followed by 600mg of T-SC with single injection device (SID) x 2 cycles. arm 2: Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with single injection device (SID) x 2 cycles, followed by 600mg of T-SC with vial (Injectable Solution) x 2 cycles.
Interventions: intervention 1: Trastuzumab Injectable Solution intervention 2: Trastuzumab Injectable Product intervention 3: Trastuzumab Injection
Intervention descriptions: intervention 1: Subcutaneous injection vial with a fixed dose of trastuzumab (600mg) and recombinant human hyaluronidase (10.000U) identical to that provided by the device. 3 weeks x 2 cycles. intervention 2: Single injection device is provided and loaded with the mixture of trastuzumab (600mg) and recombinant human hyaluronidase (10.000U) and is ready for use. 3 weeks x 2 cycles intervention 3: Powder for concentrate for solution for infusion. 1 cycle

Protocol documents:
Clinical trial NCT01308567
Conditions: Prostate Cancer
Sponsor: Sanofi
Start date: 2011-05-05; Completion date: 2018-05-01
Enrollment: 1168 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

* To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m\^2 (Arm A) or 20 mg/m\^2 (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS) in participants with metastatic castration resistant prostate cancer (mCRPC) and not previously treated with chemotherapy.

Secondary Objectives:

* To evaluate safety in the 3 treatment arms.
* To compare efficacy of cabazitaxel at 20 mg/m\^2 and 25 mg/m\^2 to docetaxel for:

  * Progression Free Survival (PFS) (RECIST 1.1)
  * Tumor progression free survival (RECIST 1.1)
  * Tumor response in participants with measurable disease (RECIST 1.1),
  * PSA response
  * PSA-Progression free survival (PSA-PFS).
  * Pain response in participants with stable pain at baseline
  * Pain progression free survival
  * Time to occurrence of any skeletal related events (SRE)
* To compare Health-Related Quality of Life (HRQL).
* To assess the pharmacokinetics and pharmacogenomics of cabazitaxel.

Detailed description:
Participants were treated until progressive disease, unacceptable toxicity, or participant's refusal of further study treatment. All participants were followed when on study treatment and after completion of study treatment during follow up period until death or the study cutoff date, whichever comes first.

Arms: arm 1: Cabazitaxel 25 mg/m\^2 intravenous (IV) infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until disease progression (DP), unacceptable toxicity or participant's refusal. arm 2: Cabazitaxel 20 mg/m\^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal. arm 3: Docetaxel (TXT) 75 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
Interventions: intervention 1: Cabazitaxel (XRP6258) intervention 2: Docetaxel (XRP6976) intervention 3: Prednisone
Intervention descriptions: intervention 1: Pharmaceutical form: Solution for injection; Route of administration: Intravenous intervention 2: Pharmaceutical form: Solution for injection'; Route of administration: Intravenous intervention 3: Pharmaceutical form: Tablet; Route of administration: Oral

Protocol documents:
Clinical trial NCT01197573
Conditions: Liver Transplantation Kidney Transplantation
Sponsor: The Cleveland Clinic
Start date: 2010-04-01; Completion date: 2018-05-01
Enrollment: 103 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We hypothesize that delayed graft function and ITBS events may be related to small blood clots (microthrombi) that collect in the kidneys and liver after cardiac death. Treatment of the DCD organs with a thrombolytic agent prior to implantation may reduce post-transplant morbidity and mortality, and may ultimately result in a greater number of transplantable livers and kidneys.

Detailed description:
The waiting list for kidney and liver transplantation continues to increase in the United States, and therefore the need grows for additional donor organs. Utilization of organs donated after cardiac death (DCD) could be one way to increase organ availability, however there are risks associated with poorer clinical outcomes, including delayed graft function and in livers specifically, ischemic-type biliary strictures (ITBS). We hypothesize that delayed graft function and ITBS events may be related to small blood clots (microthrombi) that collect in the kidneys and liver after cardiac death. Treatment of the DCD organs with a thrombolytic agent prior to implantation may reduce post-transplant morbidity and mortality, and may ultimately result in a greater number of transplantable livers and kidneys.

Arms: arm 1: Standard method of liver transplant utilizing a DCD organ arm 2: Ex-vivo treatment of liver donated after cardiac death (DCD) with rTPA arm 3: Standard method of kidney transplant utilizing a DCD organ arm 4: Ex-vivo treatment of kidney donated after cardiac death (DCD) with rTPA
Interventions: intervention 1: rTPA Treatment intervention 2: No TPA Treatment
Intervention descriptions: intervention 1: Ex-vivo treatment of DCD liver or kidney with rTPA (recombinant tissue plasminogen activator)prior to implantation intervention 2: Standard of Care

Protocol documents:
Clinical trial NCT01324401
Conditions: Peanut Allergy
Keywords: Peanut Allergy Peanut Hypersensitivity
Sponsor: Massachusetts General Hospital
Start date: 2011-03-01; Completion date: 2018-05-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Peanut allergy is one of the most serious food allergies because of its life long persistence, and the potential for severe allergic reactions. Effective oral immunotherapy would benefit patients by reducing the likelihood that they will have life-threatening accidental allergic reactions. This research study is being done to develop an effective oral immunotherapy treatment for patients with peanut allergy.

Detailed description:
Our hypothesis is that chronic antigen exposure during peanut oral immunotherapy (OIT) will induce beneficial changes in the specific immune response, including: 1) anergy of IgE effector immune cells (e.g., mast cells, basophils) resulting in clinical desensitization; 2) induction of de novo, long lived (memory) B cell responses that antagonize specific IgE and confer immune tolerance. The investigators will test this hypothesis in the following specific aims:

1. Induce desensitization in peanut allergic subjects with peanut OIT and evaluate the safety of the peanut OIT desensitization protocol.
2. Induce long-standing tolerance in peanut allergic subjects with maintenance peanut OIT and evaluate the efficacy of allergen-specific testing to predict tolerance.
3. Longitudinally evaluate basophil and mast cell reactivity in subjects receiving peanut OIT and their relationship to the induction of desensitization.
4. Longitudinally evaluate the allergen-specific B-cell repertoire in subjects receiving peanut OIT and its relationship to the induction of tolerance.

Arms: arm 1: The subjects randomized to the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. These subjects are then offered to cross-over to active treatment. arm 2: The subjects randomized to the active treatment group will receive defatted peanut flour per protocol.
Interventions: intervention 1: Peanut flour OIT
Intervention descriptions: intervention 1: Patients will receive daily escalating dosages (Peanut flour OIT) as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.

Protocol documents:
Clinical trial NCT02629991
Conditions: Prader-Willi Syndrome Hyperphagia
Keywords: Prader-Willi Syndrome (PWS) Hyperphagia
Sponsor: Montefiore Medical Center
Start date: 2015-10-01; Completion date: 2018-05-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators propose a randomized double-blind 8 week treatment trial of intranasal oxytocin (IN-OXT) vs. placebo in 24 subjects aged 5 to 18 years with PWS in order to assess IN-OXT's affect on (1) Eating behaviors (2) Repetitive and disruptive behaviors and (3) Salivary OXT levels.

Detailed description:
The investigators propose to conduct a treatment study of intranasal oxytocin (IN-OXT) vs. placebo in children and adolescents with Prader-Willi Syndrome (PWS). OXT has already been proven safe and effective in a treatment study of socialization and disruptive behavior in adults with PWS and is being used in infants with PWS in an ongoing clinical trial. The investigators hypothesize that OXT will be superior to placebo and have a positive effect on child and adolescent PWS eating and repetitive behaviors. Additional knowledge of OXT's ability to reduce overeating could lead to improvement of patient's quality of life and physical health and reduction in familial stress.

The investigators propose a randomized double-blind 8 week treatment trial of intranasal OXT vs. placebo in 24 subjects aged 5 to 18 years with PWS in order to assess IN-OXT's affect on (1) Eating behaviors (2) Repetitive and disruptive behaviors and (3) Salivary OXT levels. If superior to placebo, this data will add to the current knowledge that OXT is an effective treatment for hyperphagia as well as other problematic symptomatology of PWS.

Arms: arm 1: Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff). arm 2: Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff).
Interventions: intervention 1: Intranasal Oxytocin (IN-OXT) intervention 2: Matched Placebo
Intervention descriptions: intervention 1: Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff). intervention 2: Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff).

Protocol documents: