ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT03848871
Conditions: Plaque Psoriasis
Sponsor: Derm Research, PLLC
Start date: 2017-12-12; Completion date: 2018-12-10
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study seeks to show whether there is a benefit of prescribing Enstilar in the treatment of patients with moderate plaque type psoriasis. Subjects will receive study treatment of Enstilar foam.

Detailed description:
Approximately 20 subjects from 3 sites will be enrolled in this open-label study. Subjects will receive Enstilar foam and all adverse events and concomitant medications will be recorded.

Subjects will attend a screening visit/baseline visit and those with plaque-type psoriasis and bilateral symmetric psoriatic plaques will have a target lesion identified on knees or elbows and subjects will receive study treatment as outlined above.

Enstilar will be initiated daily for the entire study period of four weeks. Study visits will occur as follows: screening/baseline, week 2, week 4. Study assessments at each visit will be Body Surface Area (BSA,) Physicians Global Assessment (PGA,) Target lesion size, Total Lesion Severity Score (TLSS) and standard medical assessments. There will be standard medication/treatment and washout periods.

NOTE: The original study protocol dated december 20, 2017, was designed to compare the effect of Enstilar versus vehicle for the treatment of plaque psoriasis at a 1:1 ratio. A protocol amendment on March 20, 2018 eliminated the chance of placebo and made this an open-label study of the effects of Enstilar for the treatment of plaque psoriasis.

Arms: arm 1: Subjects will receive calcipotriene hydrate/betamethasone dipropionate (Enstilar) foam and apply to affected areas once daily. A target lesion located on elbow or knee will be identified by the Investigator for daily treatment with the medicated foam from Baseline through week 4.
Interventions: intervention 1: Enstilar
Intervention descriptions: intervention 1: Enstilar foam applied to affected area once daily

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT03762317
Conditions: Neonatal Abstinence Syndrome
Sponsor: Hennepin County Medical Center, Minneapolis
Start date: 2018-04-30; Completion date: 2018-12-12
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a prospective randomized double blinded study comparing the effect on duration of pharmacologic treatment and duration of hospital stay when using clonidine at 12 µg/kilogram/day as an adjunct to oral morphine as compared to morphine monotherapy in the management of term and near term infants with neonatal abstinence syndrome (NAS)

Detailed description:
Neonatal abstinence syndrome (NAS) is an emerging epidemic and has lead to a tremendous increase in cost of medical care. Opioids are the mainstay of treatment for NAS although there are concerns about possible short-term and long-term effects including but not limited to adverse neurodevelopmental outcomes. Other drugs such as clonidine, phenobarbitone, methadone and buprenorphine have been evaluated to limit the postnatal exposure to opioids in these infants. Clonidine is an alpha 2 receptor and can lessen withdrawal manifestations. The addition of clonidine at 6 µg/kilogram/day to morphine in the management of NAS has been shown to reduce the duration of pharmacotherapy by about 27% in a previous study.

A recent pilot study reported reduction of treatment duration for NAS with clonidine (12 µg/kilogram/day) monotherapy as compared to morphine monotherapy. The study reported no adverse effects in study subjects at the doses used in the study. The investigators hypothesize that there will be a minimum of 30% reduction in the treatment duration with 12 µg/kilogram/day clonidine used as adjuncts to standard morphine treatment as compared to morphine monotherapy in the management of term and near term infants with NAS

Arms: arm 1: Clonidine is started at 6mcg/kg/day and increased to 12 mcg/kg/d for the duration of the study period arm 2: Placebo solution will be given for the duration of the study period
Interventions: intervention 1: Clonidine intervention 2: Placebo
Intervention descriptions: intervention 1: clonidine will be given at 12 mcg/kg/d to the experimental arm in addition to oral morphine intervention 2: Placebo with volume similar to clonidine at 12 mcg/kg/d will be given to this arm in addition to oral morphine

Protocol documents:
Prot_SAP_001.pdf: 
 
Official Title: Clonidine as Adjunct to Morphine in the Management of Term and 
Near-term Infants with Neonatal Abstinence Syndrome 
NCT#: 03762317 
Document Date: November 30, 2018
Clinical trial NCT01456039
Conditions: Lymphoma, T-cell, Peripheral
Sponsor: Celgene
Start date: 2011-12-01; Completion date: 2018-12-14
Enrollment: 51 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study was to assess efficacy, tolerability, safety and pharmacokinetics of Romidepsin in subjects with progressive or relapsed peripheral T-cell lymphoma

Detailed description:
This is a Phase 1/2, non-randomized, open-label, single-arm trial with two phases. The first phase is a 3 + 3 dose escalation phase to determine a recommended dose for treating patients with Peripheral T-Cell Lymphoma (PTCL) or Cutaneous T-Cell Lymphoma (CTCL) based on the assessment of Dose Limiting Toxicities (DLTs).The second phase will assess efficacy at the recommended dose by measuring objective response \[Complete Response (CR), Unconfirmed Complete Response (CR(u)) or Partial Response (PR)\] and determining best overall response of each patient. Phase 1 will enroll a maximum of 12 patients and Phase 2 will enroll up to approximately 40 patients

Arms: arm 1: Patients will receive romidepsin intravenously for 4 hours on Days 1, 8, and 15 of each 28-day cycle until when/if a discontinuation criterion, e.g., disease progression, severe adverse events, or consent withdrawal.
Interventions: intervention 1: Romidepsin
Intervention descriptions: intervention 1: Intravenous dosing for 4 hours on Days 1, 8, and 15 of each 28-day cycle

Protocol documents:
Clinical trial NCT01473524
Conditions: Primary Biliary Cirrhosis
Keywords: Primary Biliary Cholangitis Primary Biliary Cirrhosis PBC Cirrhosis Liver
Sponsor: Intercept Pharmaceuticals
Start date: 2012-01-01; Completion date: 2018-12-17
Enrollment: 217 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objectives of the study were to assess the effects of Obeticholic Acid (OCA) on serum alkaline phosphatase (ALP) and total bilirubin, together as a composite endpoint and on safety in participants with primary biliary cirrhosis (PBC).

Detailed description:
The study included 2 phases: a 12-month randomized, double-blind (DB), placebo-controlled, parallel group phase, followed by a long-term safety extension (LTSE) phase up to 5 years. Participants from the 12-month DB phase, including those who received placebo, were eligible to participate in the open-label LTSE phase. The Month 12 visit from the DB phase served as the Day 1 visit of the LTSE phase. After completion of the 12-month DB phase all participants were offered the opportunity to enter an open-label LTSE for up to 5 years beginning at 5 mg OCA.

Data for the LTSE phase is reported by the randomized dose group assigned in the DB phase.

Arms: arm 1: OCA 5 milligram (mg) for 6 months and then titrating up to 10 mg based on tolerability and response for remaining 6 months of the DB phase. arm 2: OCA 10 mg for 12 months during the DB phase. arm 3: Matching placebo for 12 months during the DB phase. arm 4: After completion of the 12-month DB phase all participants were offered the opportunity to enter an open-label LTSE for up to 5 years beginning at 5 mg OCA. Initially, participants were allowed to titrate to doses up to 25 mg, however, the maximum dose was then limited to 10 mg. Participants who were previously titrated above 10 mg OCA daily were down-titrated to ≤10 mg OCA daily.
Interventions: intervention 1: Obeticholic Acid (OCA) intervention 2: Placebo
Intervention descriptions: intervention 1: OCA was administered orally once daily and provided in tablet form in 2 strengths: 5 mg and 10 mg. intervention 2: Matching placebo tablets were administered orally once daily.

Protocol documents:
Clinical trial NCT03461146
Conditions: Anemia; Hemodialysis Dependent Chronic Kidney Disease
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2018-03-05; Completion date: 2018-12-17
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
For hemodialysis subjects not receiving ESAs with anemia associated with chronic kidney disease, evaluate Hb correction and maintenance effect and safety of MT-6548.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: MT-6548
Intervention descriptions: intervention 1: Oral tablet

Protocol documents:
Prot_000.pdf: 

















































































































































































SAP_001.pdf:
Clinical trial NCT03530631
Conditions: Expectancy Versus Pharmacotherapy Effect of Adderall
Sponsor: University of Alabama at Birmingham
Start date: 2018-11-10; Completion date: 2018-12-18
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this balanced-placebo design study is to pilot a larger study to further explore the current evidence that stimulant medications are not cognitive enhancers, despite this rampant belief in young adults. While the lack of cognitive enhancement from stimulant medication has been documented in prior research, this study is the first to utilize neuroimaging technology to examine brain regions activated during neurocognitive tasks when participants believe they have been administered stimulant medication or placebo.

Detailed description:
This is a 2 X 2 within subjects, balanced placebo design and all participants will experience each of the four conditions during four sequential weeks. Medication administered (Adderall vs. placebo) is crossed with instructional set (truth vs. deception) and participants' performance on neurocognitive tasks is compared across these groups. For example, participants are either given stimulant medication or placebo, and are either accurately told or inaccurately told that they received stimulant medication or placebo. Neuroimaging is being utilized to investigate whether participants' expectations regarding the benefits of stimulant medication affects their performance on neurocognitive tasks. The hypothesis of the study is that participants' expectations regarding stimulant medication will affect their performance on neurocognitive tasks, rather than the actual effect of the medication.

Arms: arm 1: Participants will be told they are receiving Adderall and will actually be administered Adderall. arm 2: Participants will be told they are receiving placebo and will actually be administered placebo. arm 3: Participants will be told they are receiving Adderall and will actually be administered placebo. arm 4: Participants will be told they are receiving placebo and will actually be administered Adderall.
Interventions: intervention 1: Adderall intervention 2: Placebo
Intervention descriptions: intervention 1: Participants will be administered Adderall intervention 2: Participants will be administered placebo

Protocol documents:
Prot_001.pdf:
Clinical trial NCT03402386
Conditions: Anemia; Peritoneal Dialysis Dependent Chronic Kidney Disease
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2018-01-03; Completion date: 2018-12-20
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the efficacy and safety of MT-6548 in peritoneal dialysis subjects with anemia associated with chronic kidney disease

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: MT-6548
Intervention descriptions: intervention 1: Oral tablet

Protocol documents:
Prot_000.pdf: 













































































































































































SAP_001.pdf:
Clinical trial NCT01643850
Conditions: Pigmented Villonodular Synovitis PVNS Giant Cell Tumor of the Tendon Sheath GCCTS Tenosynovial Giant Cell Tumor Localized or Diffused Type GCTS
Keywords: Pigmented Villonodular Synovitis PVNS Giant cell tumor of the tendon sheath GCCTS Tenosynovial giant cell tumor (localized or diffused type) GCTS MCS110
Sponsor: Novartis Pharmaceuticals
Start date: 2012-04-23; Completion date: 2018-12-21
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study, designed as a proof of concept study of MCS110 in pigmented villonodular synovitis, assessed the clinical response to MCS110 treatment in Pigmented Villonodular Synovitis (PVNS) patients, after a single or multiple intravenous doses of MCS110, using magnetic resonance imaging to assess tumor volume, and evaluated the pharmacokinetics/pharmacodynamics, safety and tolerability in this population.

Detailed description:

Arms: arm 1: Participants will receive a single dose of 10mg/kg on day 1 administered by regular infusion. arm 2: Part A: single-dose placebo to match MCS110 (10 mg/kg, 1 h i.v. infusion) Part B: single dose placebo to match MCS110 (10 mg/kg, 1 h i.v. infusion administered i.v. at Day 1, followed by 6 doses of placebo to match MCS110 (10 mg/kg) arm 3: Part C: MCS110 3 mg/kg (i.v. infusion) arm 4: Part C: MCS110 5 mg/kg (i.v. infusion) arm 5: Part C: MCS110 10 mg/kg (i.v. infusion) arm 6: Part C: MCS110 3 mg/kg (i.v. infusion) \& MCS110 10 mg/kg (i.v. infusion) arm 7: Part C: MCS110 5 mg/kg (i.v. infusion) \& MCS110 10 mg/kg (i.v. infusion)
Interventions: intervention 1: MCS110 intervention 2: Placebo
Intervention descriptions: intervention 1: Patients will receive up to 6 doses of MCS110 (3 or 5 or 10mg/kg) administered intravenously once every 4 weeks. Before each dosing, safety will be assessed. intervention 2: Participants will receive a single dose of NaCl on day 1 through intravenous infusion.

Protocol documents:
Prot_000.pdf: 
Novartis Institutes for BioMedical Research
MCS110
Clinical Trial Protocol CMCS110X2201
A Phase II randomized, double-blind (Part A, B and C), 
placebo controlled (Part A and B only), study to assess 
safety, tolerability and efficacyof MCS110 on tumor size in 
patients with pigmented villonodular synovitis (PVNS)
Document type:
Amended Protocol Version
EUDRACT number:
2011-002951-32
Version number:
v07(incorporating Amendment 07)(Clean)
Development phase:
II
Release date:
03-Jul-2018
Property of Novartis
Confidential
May not be used, divulged, published, or otherwise disclosed
without the consent of Novartis



















































































































































































































































































































SAP_001.pdf:
Clinical trial NCT01349660
Conditions: Glioblastoma Multiforme
Keywords: Glioblastoma multiforme GBM Bevacizumab PI3K Pathway BKM120
Sponsor: SCRI Development Innovations, LLC
Start date: 2011-12-01; Completion date: 2018-12-29
Enrollment: 88 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In this phase I/II study,investigators are evaluating the feasibility and efficacy of the combination of BKM120, an oral inhibitor of PI3 kinase, and bevacizumab in the treatment of patients with relapsed/refractory GBM. In the Phase I part of the trial, the optimal BKM120 dose to be administered with a standard dose of bevacizumab will be determined in patients with refractory solid tumors. Although it is unlikely that the concurrent administration of bevacizumab will alter the pharmacokinetics of BKM120, limited pharmacokinetic sampling will be performed on all patients treated during the Phase II portion of the study. Assuming this combination is feasible, the Phase II portion of the study will proceed, using the doses determined in the Phase I portion. In the phase II portion, eligible patients will be limited to those with recurrent/progressive GBM following 1st line combined modality therapy.

Detailed description:
This is an open-label, non-randomized Phase I study of patients with advanced refractory solid tumors followed by a Phase II study for the second-line treatment of patients with relapsed/refractory glioblastoma multiforme.

In the phase I part of the study the optimal dose of BKM120 when combined with bevacizumab was determined. In the Phase II part of this study, patients with relapsed/refractory GBM following first line therapy are being treated with the BKM120/bevacizumab combination. Limited BKM120 pharmacokinetic evaluation will be performed on all patients treated during this part of the study. Patients will be reevaluated for response to treatment after 2 cycles (8 weeks). Patients with objective response or stable disease will continue treatment, with subsequent reevaluations every 8 weeks, until disease progression or unacceptable toxicity occurs.

Two populations of patients with relapsed/refractory GBM will be treated in the Phase II trial: 1) patients with no previous exposure to bevacizumab (N= 55) and 2) patients who received bevacizumab as part of first-line combined modality treatment (N= 20).

Arms: arm 1: Phase I:

BKM 120 orally (PO) once daily (dose is 60mg or 80mg). Bevacizumab: 10mg/kg intravenous (IV) every 2 weeks

Phase II:

BKM 120 orally (PO) once daily - dose is optimal dose determined in Phase I. Bevacizumab: 10mg/kg intravenous (IV) every 2 weeks
Interventions: intervention 1: Bevacizumab intervention 2: BKM120
Intervention descriptions: intervention 1: Bevacizumab 10 mg/kg IV every 2 weeks intervention 2: BKM120 orally (PO) once daily

Protocol documents:
Clinical trial NCT02162771
Conditions: Lymphoma, Follicular
Keywords: Advanced Follicular Lymphoma
Sponsor: Celltrion
Start date: 2014-07-14; Completion date: 2018-12-29
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a Phase 3 prospective, randomised, parallel-group, active controlled, double blind, multicentre, international study with 2 coprimary endpoints designed to demonstrate equivalence in pharmacokinetics (Part 1), as well as noninferiority in efficacy (Part 2), of CT-P10 to Rituxan when coadministered with CVP and to assess efficacy and safety in patients with advanced (stage III-IV) FL. Part 1 and Part 2 of the study will run in parallel.

Detailed description:

Arms: arm 1: Patient treated with CT-P10 (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 \[max 2 mg\] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period.

Patients having responses during Core Study Period treated with CT-P10 (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period. arm 2: Patient treated with Rituxan (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 \[max 2 mg\] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period.

Patients having responses during Core Study Period treated with Rituxan (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.
Interventions: intervention 1: Rituxan intervention 2: CT-P10 intervention 3: Cyclophosphamide intervention 4: Vincristine intervention 5: Prednisone
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol documents:
Clinical trial NCT01364727
Conditions: Thymoma Thymus Cancer Thymic Carcinoma
Sponsor: Heather Wakelee
Start date: 2011-06-01; Completion date: 2018-12-31
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A research study of the drug amrubicin in patients with cancer of the thymus (thymoma or thymic carcinoma). We hope to learn whether this drug is an effective and safe treatment for thymic cancers.

Detailed description:
Amrubicin, a synthetic 9-aminoanthracycline, is structurally similar to doxorubicin, but has a different primary mode of action. It acts primarily as an inhibitor of DNA topoisomerase II, exerting its cytotoxic effects by stabilizing a topoisomerase II mediated cleavable complex. This inhibition is significantly more than that seen in doxorubicin, which, in contrast, tends to demonstrate more DNA intercalation than amrubicin.

It has not yet been evaluated for use in thymic malignancies, but given its efficacy in NSCLC and small cell lung cancer (SCLC), as well as the known efficacy of other anthracyclines and topoisomerase II inhibitors in first-line thymoma treatment, it warrants study for use in the second line and beyond in refractory or relapsed patients. Unlike doxorubicin, amrubicin has had minimal cardiotoxicity even with ongoing use, which also makes it a promising agent for use in the second line even for patients who have previously been exposed to, and potentially helped by, doxorubicin.

Arms: arm 1: Amrubicin 35mg/m2 IV days 1-3 every 3 weeks
Interventions: intervention 1: Amrubicin
Intervention descriptions: intervention 1: 35 mg/m2; IV on days 1-3 each 3 week cycle

Protocol documents:
Clinical trial NCT03256968
Conditions: Cystic Fibrosis
Sponsor: University of Alabama at Birmingham
Start date: 2017-01-27; Completion date: 2018-12-31
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to explore the combination of ataluren and ivacaftor as a treatment for patients with nonsense mutation cystic fibrosis

Detailed description:
Cystic Fibrosis (CF) is a life threatening genetic disorder resulting from mutations found in the CF gene known as the cystic fibrosis transmembrane conductance regulator or CFTR. This defect prevents correct chloride absorption in and out of the cells The purpose of this study is to explore the combination of ataluren and ivacaftor as a treatment for patients with a specific cystic fibrosis mutation

Arms: arm 1: dose of the drug administered (mg/kg body weight)
Interventions: intervention 1: Ataluren
Intervention descriptions: intervention 1: ataluren

Protocol documents:
Prot_SAP_000.pdf: