ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01524133
Conditions: Posttraumatic Stress Disorder
Keywords: combat-related PTSD Posttraumatic stress disorder prolonged exposure therapy sertraline military veterans VA hospital mental illness
Sponsor: VA Ann Arbor Healthcare System
Start date: 2011-11-01; Completion date: 2017-05-01
Enrollment: 223 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The current research study aims to compare the effectiveness of two proven treatments for posttraumatic stress disorder (PTSD): Prolonged Exposure (PE), sertraline, and their combination. In addition, the investigators are examining predictors of response to these two treatments and how PTSD symptoms, thoughts, and biological factors may be changed by such treatments. Biological mechanisms of change are also examined including emotion processing and regulation in fMRI, HPA axis function, and genetics and genomics. In addition, the investigators will examine acceptability of each treatment and reasons for ending treatment.

Detailed description:

Arms: arm 1: 24 weeks of sertraline + enhanced medication management arm 2: Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline arm 3: Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo
Interventions: intervention 1: Sertraline intervention 2: Prolonged Exposure Therapy
Intervention descriptions: intervention 1: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8. intervention 2: up to 13 sessions of prolonged exposure

Protocol documents:
Clinical trial NCT01816074
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Mothers ADHD Treatment Child
Sponsor: Seattle Children's Hospital
Start date: 2012-10-01; Completion date: 2017-05-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
We hypothesize that successfully treating maternal Attention Deficit Hyperactivity Disorder (ADHD) will have a beneficial effect that extends to the child. We believe that multi-component interventions combining maternal stimulant medication, Lisdexamfetamine (LDX), and Behavioral Parent Training (BPT) will improve parenting, maternal, and child outcomes. In terms of improved parenting, we hypothesize that some mothers may respond well to LDX or BPT alone and therefore may not require multi-modal treatment, whereas others may benefit most from multi-modal treatment

Detailed description:
The overarching goal of this study is to construct and evaluate an adaptive intervention (i.e., an individualized treatment protocol that is adjusted based on the child-mother dyad's initial response to treatment) to improve the trajectory of ADHD outcomes in at-risk children. Our primary outcome measure for the child will be whether child ADHD symptoms on the Conners Parent and Teacher Rating Scales decreased at the completion of the study. Our secondary outcome measure will be whether there was a need for medication for the child over the course of the study. The primary outcome for the mother will be the Conners Adult ADHD Rating Scale (CAARS) Attention Scale and the Clinical Global Impression-Severity scale (CGI-S).

Arms: arm 1: The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to enhanced medication arm 2: The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to enhanced behavioral treatment. arm 3: The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to combined treatment (adding Behavior Parent Training). arm 4: The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to active ADHD medication, Vyvanse.
Interventions: intervention 1: Vyvanse (lisdexamphetamine) intervention 2: Behavior Parent Training
Intervention descriptions: intervention 1: Active ADHD drug, Vyvanse, is administered to mother. intervention 2: Mother is given 8 weeks of individual sessions of behavioral parent training

Protocol documents:
Clinical trial NCT02046382
Conditions: Cesarean Section Pain, Postoperative
Keywords: IV Acetaminophen Cesarean Section Pain, Postoperative
Sponsor: TriHealth Inc.
Start date: 2014-01-01; Completion date: 2017-05-01
Enrollment: 132 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being done to evaluate the scheduled use of intravenous (IV) acetaminophen among cesarean section patients. The study hopes to find out if patients who receive scheduled IV acetaminophen for 48 hours following delivery have lower self-reported pain scores and use less narcotic pain medication than patients who do not receive IV acetaminophen.

Detailed description:
See Brief Summary

Arms: arm 1: Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given. arm 2: Subjects will receive a 100mL dose of saline every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
Interventions: intervention 1: IV Acetaminophen intervention 2: Placebo
Intervention descriptions: intervention 1: 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given. intervention 2: 100 mL of Normal Saline every 8 hours for 48 hours. The first does will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

Protocol documents:
Clinical trial NCT02132247
Conditions: Athletic Injuries
Keywords: Minor athletic injuries Pain Diclofenac Topical
Sponsor: IBSA Institut Biochimique SA
Start date: 2014-05-01; Completion date: 2017-05-01
Enrollment: 104 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of this study is to determine whether Flector Patch is safe for use in children. The secondary purpose is to assess blood levels of diclofenac, the active ingredient in Flector Patch.

Detailed description:

Arms: arm 1: Flector Patch is a transdermal delivery system containing 180 mg of diclofenac hydroxyethylpyrrolidine. The patch will be used twice-a-day for up to two weeks, or until pain resolution, whichever comes first.
Interventions: intervention 1: Diclofenac hydroxyethylpyrrolidine
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02224846
Conditions: Erectile Dysfunction
Sponsor: Eli Lilly and Company
Start date: 2014-10-01; Completion date: 2017-05-01
Enrollment: 635 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and effectiveness of the study drug, taken once daily, known as tadalafil in Chinese participants with erectile dysfunction (ED). The study will last about up to 25 months for each participant.

Detailed description:

Arms: arm 1: 2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2). arm 2: 5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
Interventions: intervention 1: Tadalafil
Intervention descriptions: intervention 1: Administered orally

Protocol documents:
Clinical trial NCT02391545
Conditions: CD20+ Follicular Lymphoma
Keywords: Follicular Lymphoma Previously Untreated
Sponsor: SecuraBio
Start date: 2014-12-01; Completion date: 2017-05-01
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Two-arm, Phase 1b/2 Study of duvelisib Administered in Combination with Rituximab or Obinutuzumab in Subjects with Previously Untreated CD20+ Follicular Lymphoma.

Detailed description:
This is a two-arm, open-label, Phase 1b/2 trial designed to evaluate the safety and efficacy of duvelisib in combination with rituximab and duvelisib in combination with obinutuzumab in subjects with previously untreated CD20+ FL.

The study will be conducted in two parts, a Safety Lead-in (Part 1) followed by a randomized, 2-Stage Design in Part 2. Each treatment arm will be assessed independently for dose limiting toxicity (DLT) within Part 1.

Arms: arm 1: Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles.

Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26. arm 2: Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles.

Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.
Interventions: intervention 1: Duvelisib intervention 2: Rituximab intervention 3: Obinutuzumab
Intervention descriptions: intervention 1: PI3K Inhibitor intervention 2: monoclonal antibody intervention 3: monoclonal antibody

Protocol documents:
Clinical trial NCT02596867
Conditions: Breast Cancer
Keywords: B adrenergic pathway B Blocker
Sponsor: Texas Tech University Health Sciences Center, El Paso
Start date: 2015-09-01; Completion date: 2017-05-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This trial is a Phase II study using the "window-of-opportunity" design in which the treatment-free window between breast cancer diagnosis and surgical tumor resection is used to study the biological effects of the beta blocker propranolol .

Detailed description:
* Patients will be recruited from the Garbar Breast Care Center and University Medical Center following diagnosis of invasive breast cancer by breast biopsy.
* The sympatholytic nonselective beta blocker propranolol will be administered to all participants in a non-randomized manner at an equal dose of 1.5 mg/kg/day.
* Following surgical resection of the tumor , the primary endpoint of this study is quantified by comparing the proliferative index of the tumor before propranolol administration (quantified using the initial tumor biopsy) and after 3 weeks of propranolol (quantified using the surgically resected tumor).
* Additional molecular analyses and evaluation of safety and toxicity will also be performed to better understand the effects of this treatment on breast cancers and patient adherence to the drug.

Arms: arm 1: all subjects will receive the experimental drug
Interventions: intervention 1: propanolol
Intervention descriptions: intervention 1: Participants will take 1.5 mg/kg/day propranolol, twice daily for 3 weeks until surgical resection of the breast tumor is performed

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT02633371
Conditions: Hyperhidrosis
Sponsor: University of Colorado, Denver
Start date: 2016-02-01; Completion date: 2017-05-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a single-center, prospective, open-label, outpatient pilot study evaluating the efficacy and tolerability of oxybutynin gel for axillary hyperhidrosis.

Detailed description:
This study will determine if daily application of topical oxybutynin 3% gel reduces the symptoms of primary axillary hyperhidrosis in adolescents and young adults. It will also assess the impact of daily topical oxybutynin 3% gel on Health Related Quality of Life (HRQOL); determine if daily topical oxybutynin 3% gel has a treatment effect at distant, untreated sites; and assess the local and systemic tolerability of daily topical oxybutynin 3% gel. Finally, the study will determine the treatment effect size, if one exists, in order to power a larger, placebo-controlled study in the future.

Arms: arm 1: Oxybutynin 3% gel, 1 gram of product (56 mg oxybutynin) topically to each armpit daily for 4 weeks
Interventions: intervention 1: Oxybutynin 3% gel
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT03010631
Conditions: Healthy Volunteers
Sponsor: Sucampo Pharma Americas, LLC
Start date: 2016-11-16; Completion date: 2017-05-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A study to compare the pharmacokinetics and food-effect bioavailability of sprinkle formulation of lubiprostone, as compared to lubiprostone capsules in healthy volunteers.

Detailed description:
To compare the pharmacokinetics of the sprinkle formulation of lubiprostone, as compared to lubiprostone capsules and to determine the effect of food on the bioavailability and plasma pharmacokinetics of lubiprostone sprinkle.

Arms: arm 1: Cohort 1: Treatment A. Capsule Fasted (7-day Washout) then Treatment B. Sprinkle Formulation, Fasted arm 2: Cohort 1: Treatment B. Sprinkle Formulation, Fasted (7-day Washout) then Treatment A. Capsule Fasted arm 3: Cohort 2: Treatment C: Sprinkle Formulation, Fed (7-day Washout) then Treatment D: Sprinkle Formulation, Fasted arm 4: Cohort 2: Treatment D: Sprinkle Formulation, Fasted (7-day Washout) then Treatment C. Sprinkle Formulation, Fed
Interventions: intervention 1: Cohort 1: Lubiprostone Capsule, Fasted intervention 2: Cohort 1: Lubiprostone Sprinkle Formulation, Fasted intervention 3: Cohort 2: Lubiprostone Sprinkle Formulation, Fed intervention 4: Cohort 2: Lubiprostone Sprinkle Formulation, Fasted
Intervention descriptions: intervention 1: Lubiprostone soft gelatin capsule administered under fasted conditions intervention 2: Lubiprostone sprinkle formulation administered under fasted conditions intervention 3: Lubiprostone sprinkle formulation administered under fed conditions intervention 4: Lubiprostone sprinkle formulation administered under fasted conditions

Protocol documents:
Clinical trial NCT01941927
Conditions: Melanoma
Keywords: Melanoma Wild-type BRAF
Sponsor: Adil Daud
Start date: 2013-09-10; Completion date: 2017-05-03
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multicenter phase II clinical study of trametinib in combination with GSK2141795 in patients with BRAF wild-type mutation melanoma. All patients will receive continuous dosing of trametinib (2 mg) in combination with GSK2141795 (25 mg) oral daily until progression of disease, withdrawal of consent, or the development of intolerable treatment associated toxicity. Imaging (CT or MRI) will be performed within 7 days prior to day 1 of Odd Cycles, starting with Cycle 3.

Patients may continue treatment with trametinib in combination with GSK2141795 on trial until disease progression or the development of unacceptable toxicity that does not improve with maximal supportive care or dose reduction per protocol.

Treatment-associated adverse events will be assessed based on clinical and laboratory findings using the Common Toxicity Criteria for Adverse Events, version 4.0. Adverse event (AE) assessments will be performed every week through cycle 3 day 1, and on day 1 for every cycle thereafter. AEs and Serious adverse events (SAE)s will be monitored by UCSF's Data Safety Monitoring Committee.

Safety assessments will include medical history, physical examination, Complete Blood Count (CBC) with differential, chemistries panel, thyroid function and pregnancy tests, ECGs, and ophthalmology evaluations. Screening assessments will also include a transthoracic echocardiogram or multiple-gated acquisition (MUGA) scan, and brain imaging.

It is estimated that 48 patients will complete the study.

Detailed description:

Arms: arm 1: Trametinib (GSK1120212)

* Oral
* 2 mg
* Daily
* Number of Cycles: until progression or unacceptable toxicity develops

GSK2141795

* Oral
* 25 mg
* Daily
* Number of Cycles: until progression or unacceptable toxicity develops
Interventions: intervention 1: Trametinib (GSK1120212) intervention 2: GSK2141795
Intervention descriptions: intervention 1: Trametinib is a highly selective allosteric inhibitor of MEK1 and MEK2 activation and kinase activity. intervention 2: GSK 2141795 is an ATP competitive subnanomolar pan-AKT inhibitor. In order to measure the true potency of GSK 2141795, potency (Ki\*) values were determined in a filter binding assay using lower enzyme concentrations (0.1, 0.7, and 0.2 nM for human AKT1, AKT2, and AKT3, respectively). Using a sandwich ELISA, GSK 2141795 inhibited phosphorylation of GSK-3β in BT474 and LNCaP cell lines with EC50 values of 143 and 34 nM, respectively. Since phosphorylation of GSK-3β can be modulated by other enzymes (PKA, PKC, and RSK),cellular activity of GSK 2141795 was evaluated using a phospho-PRAS40 ELISA. GSK 2141795 inhibited the phosphorylation of PRAS40 with EC50 values of 39 and 55 nM for BT474 and LNCaP cells, respectively.

Protocol documents:
Clinical trial NCT01987232
Conditions: Extensive-Stage Small-Cell Lung Cancer
Sponsor: Amgen
Start date: 2013-11-05; Completion date: 2017-05-04
Enrollment: 32 participants; Allocation: ; Intervention model: SEQUENTIAL

Brief summary:
The purpose of this study is to determine the maximum tolerated dose and assess the safety, tolerability and activity of carfilzomib given in combination with carboplatin and etoposide as initial therapy for patients with extensive-stage small-cell lung cancer (ES SCLC).

Detailed description:

Arms: arm 1: Participants received carfilzomib on days 2, 3, 9, and 10 of each 21-day cycle as per the dose escalation schema, carboplatin at a target area under the curve (AUC) of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.
Interventions: intervention 1: Carfilzomib intervention 2: Carboplatin intervention 3: Etoposide
Intervention descriptions: intervention 1: Administered by intravenous infusion. intervention 2: Administered by intravenous infusion. intervention 3: Administered by intravenous infusion.

Protocol documents:
Clinical trial NCT01386554
Conditions: Proteinuria Idiopathic Membranous Nephropathy
Keywords: H.P. Acthar Gel Acthar nephrotic syndrome idiopathic membranous nephropathy proteinuria
Sponsor: Mallinckrodt
Start date: 2011-08-01; Completion date: 2017-05-05
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to provide nephrologists with additional clinical evidence regarding the efficacy and safety of Acthar in subjects with treatment-resistant idiopathic membranous nephropathy. Approximately sixty (60) subjects will be randomized in this double-blind, parallel-group, placebo-controlled, multicenter study comparing Acthar and Placebo administered 2 times per week for a 24-week treatment period followed by a 24-week observation period. The primary objective of this study is to assess the proportion of treatment-resistant subjects (defined as subjects who either have had no response or have suffered a relapse after achieving a partial response to their most recent standard treatment regimen) who have a complete or partial remission of proteinuria in nephrotic syndrome due to idiopathic membranous nephropathy after 24 weeks of treatment.

Detailed description:

Arms: arm 1: Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) two times per week arm 2: Placebo (1.0 mL) two times per week arm 3: Acthar (Repository Corticotropin Injection) 40 U (1.0 mL) two times per week
Interventions: intervention 1: Repository Corticotropin Injection intervention 2: Placebo
Intervention descriptions: intervention 1: Acthar given SC for 6 months intervention 2: Placebo contains the same inactive ingredients as that used for H.P. Acthar Gel without the API.

Placebo given SC for 6 months (80 U two times a week).

Protocol documents:
Clinical trial NCT01384734
Conditions: Infection, Human Immunodeficiency Virus
Sponsor: ViiV Healthcare
Start date: 2011-07-26; Completion date: 2017-05-12
Enrollment: 254 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety, efficacy, tolerability and pharmacokinetics of four doses of BMS-663068 with Raltegravir (RAL) + Tenofovir Disoproxil Fumarate (TDF). At least 1 dose of BMS-663068 can be identified which is safe, well tolerated, and efficacious when combined with RAL + TDF for treatment-experienced HIV-1 infected subjects. PHENOSENSE® is a registered trademark of Monogram Biosciences.

Detailed description:
Masking: Double-blind for BMS-6630368 treatment groups until the Week 24 Primary Endpoint analysis, then open label. The reference groups is all open-label.

Arms: 5 (4 BMS-663068 treatment groups and 1 reference group)

Intervention Model: Parallel (with unblinding after the Week 24 primary endpoint analysis)

Arms: arm 1: Treatment Group 1 arm 2: Treatment Group 2 arm 3: Treatment Group 3 arm 4: Treatment Group 4 arm 5: Treatment Group 1 (reference arm)
Interventions: intervention 1: BMS-663068 400 mg intervention 2: BMS-663068 800 mg intervention 3: BMS-663068 600 mg intervention 4: BMS-663068 1200 mg intervention 5: Raltegravir 400 mg intervention 6: Tenofovir 300 mg intervention 7: Ritonavir 100 mg intervention 8: Atazanavir 300 mg
Intervention descriptions: intervention 1: Tablets, Oral, 400 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose intervention 2: Tablets, Oral, 800 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose intervention 3: Tablets, Oral, 600 mg, once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose intervention 4: Tablets, Oral, 1200 mg, once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose intervention 5: Tablets, Oral, 400 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose intervention 6: Tablets, Oral, 300 mg, Once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose intervention 7: Tablets, Oral, 100 mg, Once daily, 96 weeks intervention 8: Capsules, Oral, 300 mg, Once daily, 96 weeks

Protocol documents: