ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02676375
Conditions: Smoking Cessation Schizophrenia
Sponsor: Brentwood Biomedical Research Institute
Start date: 2014-01-01; Completion date: 2016-06-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study investigators will enroll 45 treatment seeking, cigarette smokers with a Diagnostic and Statistical Manual (DSM-IV) diagnosis of schizophrenia who will be randomly assigned into three arms of treatment for smoking cessation treatment, receiving either 1. Control: "standard therapy" (n=15), including stepwise monotherapy of nicotine patch or bupropion sustained release, 2. Extended treatment with combination bupropion, nicotine patch, and nicotine lozenge for 6 months (n=15), or 3. Extended treatment with combination bupropion, nicotine patch, and nicotine lozenge for 6 months with home visits (n=15) and phone calls to the home or living facility. During all treatments, participants will receive weekly smoking cessation group counseling, as is standard for smoking cessation treatment. At the time of enrollment, participants will complete a one-study visit lead-in to complete baseline assessments, psychological and medical evaluation, and comprehensive assessment of drug use to determine study eligibility. Once determined to be eligible for the trial, participants will be randomly assigned to one of the treatment arms using a randomization procedure. The "standard therapy" treatment arm, or control group, will receive either nicotine patch taper starting at 21 milligrams (mg) daily, nicotine lozenge as needed, and/or bupropion sustained release at 150mg daily for 3 days, then 150 mg twice a day for a total of 12 weeks. The extended therapy arm will start the nicotine patch at 21mg daily with as needed nicotine lozenge for breakthrough cravings and initiation of bupropion sustained release at 150mg daily for 3 days a week prior to starting nicotine replacement, then 150 mg twice daily for 6 months (as tolerated). The third arm will be identical to the second arm except for the added home visit intervention.

Detailed description:

Arms: arm 1: Treatment as usual starting with one smoking cessation medication plus group therapy. arm 2: Extended treatment with multiple standard medications plus group therapy. arm 3: Extended treatment with multiple standard medications plus group therapy plus home visits.
Interventions: intervention 1: Combination Bupropion + NRTs intervention 2: Extended Treatment intervention 3: Home Visits & Calls intervention 4: Monotherapy
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT02679911
Conditions: Foot Dermatoses
Keywords: Onychomycosis
Sponsor: Galderma R&D
Start date: 2015-09-01; Completion date: 2016-06-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objective of this study is to compare subject's compliance and satisfaction for two modes of treatment of toenails infection (Onychomycosis) with Loceryl Nail Lacquer (Loceryl NL) and Ciclopirox Nail Lacquer (Ciclopirox NL).

Detailed description:
A total of 20 subjects are to be included in 1 site in Germany.

Methodology:

Subjects will receive the following treatments on the right or left toenails:

* Loceryl Nail Lacquer to be applied once weekly for 12 weeks on all affected toenails of one foot.
* Ciclopirox Nail Lacquer to be applied once daily for 12 weeks on all affected toenails of the opposite foot.

Arms: arm 1: Amorolfine hydrochloride NL 5% to be applied once weekly for 12 weeks on all affected toenails of one foot arm 2: Ciclopirox NL 8% to be applied once daily for 12 weeks on all affected toenails of the opposite foot
Interventions: intervention 1: Loceryl NL intervention 2: Ciclopirox NL
Intervention descriptions: intervention 1: Topical over the entire toenail plate of all affected toenails, once weekly in the evening (at bed time) after filing down the affected toenails. intervention 2: Topical over the entire toenail plate of all affected toenails and surrounding skin, once daily in the evening (at bed time) after removing the free toenail edge and diseased toenails if needed

Protocol documents:
Clinical trial NCT02704702
Conditions: Hypertension
Keywords: Fimasartan
Sponsor: Boryung Pharmaceutical Co., Ltd
Start date: 2016-03-01; Completion date: 2016-06-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the pharmacokinetics and safety of Fimasartan and rosuvastatin when coadministered or administered alone as a single dose or as multiple doses to healthy male subjects.

Detailed description:
This is an open-label, randomized, 6-sequence, 3-period, 3-way crossover study. Within each period, randomized subjects will be 2 dosing regimens with the same drug(fimasartan or rosuvastatin) or study drug combination(fimasartan+rosuvastatin) on day 1 and quaque die(qd) from day 4 to day 10. After day 1 and day 10 dosing will be followed by pharmacokinetic sampling for 48 hours or 72 hours.

Arms: arm 1: Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment C)

There will be a washout of at least 7 days between the each period. arm 2: Period 1(Treatment A) → Period 2(Treatment C) → Period 3(Treatment B)

There will be a washout of at least 7 days between the each period. arm 3: Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment 3)

There will be a washout of at least 7 days between the each period. arm 4: Period 1(Treatment B) → Period 2(Treatment C) → Period 3(Treatment A)

There will be a washout of at least 7 days between the each period. arm 5: Period 1(Treatment C) → Period 2(Treatment A) → Period 3(Treatment B)

There will be a washout of at least 7 days between the each period. arm 6: Period 1(Treatment C) → Period 2(Treatment B) → Period 3(Treatment A)

There will be a washout of at least 7 days between the each period.
Interventions: intervention 1: Fimasartan intervention 2: Rosuvastatin intervention 3: Fimasartan + Rosuvastatin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02709096
Conditions: Acne Vulgaris
Sponsor: BioPharmX, Inc.
Start date: 2016-04-01; Completion date: 2016-06-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 2a study which is being conducted in healthy volunteers in order to evaluate the comparative reduction of Propionibacterium acnes in-vivo following once daily topical administration of BPX-01 Minocycline 1% Topical Gel (BPX-01) or BPX-01 Vehicle control.

Detailed description:
The objective of this study is to evaluate the comparative reduction of Propionibacterium acnes (P. acnes) in-vivo following once daily topical administration of BPX-01 Minocycline 1% Topical Gel or BPX-01 Vehicle control Gel.

A secondary objective is to assess the tolerance of the treatment regimen versus a vehicle control. Safety laboratory data (chemistry and hematology) and plasma levels of minocycline are also of significant interest to the sponsor.

This is a single center, randomized, double blind, two-cell, vehicle controlled P. acnes study. All subjects will be randomized 2:1 to 1% BPX-01 or vehicle control to be applied as a topical gel once daily for four (4) weeks.

This is a six (6) week study with a four (4) week treatment period and a two (2) week post treatment follow up visit. The clinical endpoint is in-vivo quantification of P.acnes. The safety/tolerance endpoints are; observer reported: erythema, scaling-peeling, edema, and subject reported: tightness, burning-stinging, and itching. Plasma levels of minocycline and basic hematology and chemistry laboratory values will be collected.

Arms: arm 1: BPX-01, 1% Topical Gel; applied once daily to the face for four weeks. arm 2: BPX-01, Vehicle Gel; applied once daily to the face for four weeks.
Interventions: intervention 1: BPX-01, 1% Topical Gel intervention 2: BPX-01 Vehicle Gel
Intervention descriptions: intervention 1: topical gel, applied to the forehead, cheeks, nose and chin intervention 2: topical gel, applied to the forehead, cheeks, nose and chin

Protocol documents:
Clinical trial NCT02716714
Conditions: Actinic Keratosis
Keywords: Korean
Sponsor: Korea University
Start date: 2015-04-01; Completion date: 2016-06-01
Enrollment: 77 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluate the efficacy and safety of ingenol mebutate gel 0.015% on face and scalp \& 0.05% on trunk and extremities in Korean patient with actinic keratosis.

Detailed description:
The mechanism of action of ingenol mebutate for actinic keratosis(AK) treatment involves a rapid induction of necrosis followed by neutrophil-mediated, antibody-dependent cellular cytotoxicity (ADCC) of residual lesion. As the ingenol mebutate infiltrates the cell membrane, it increases intracellular Ca2+ concentration which leads to mitochondrial swelling and disruption of mitochondrial membrane within hours. The release of intra-mitochondrial Ca2+ into the cytoplasm leads to depletion of adenosine triphosphate (ATP) and a rapid induction of cell death by necrosis. This process occurs within 1 hour of application, which explains why the treatment period requires only 2 or 3 days of treatment. As the next phase, the cellular necrosis is accompanied by a robust inflammatory response through the release of proinflammatory cytokines from skin cells and tumor cells undergoing necrosis. The release of these proinflammatory cytokines into the dysplastic cells mediates the process of neutrophil recruitment through paracrine signaling and activation of endothelial cells. Here, the neutrophil mediated ADCC occurs, where activated neutrophils attach to the fragment, crystallized (Fc) parts of antibodies of dysplastic cells and destroys the residual dysplastic epidermal cells. In this way, the ingenol mebutate eradicates any residual tumor cells and prevents recurrence of actinic keratosis.As described above, the rapid effect and dual mechanism of action of ingenol mebutate gel allows not only a short-course therapy (2 or 3 days of application) for the elimination of actinic keratosis but also, the benefit for eradication of any residual lesions preventing the recurrence and the progression of AK into squamous cell carcinoma (SCC).

Arms: arm 1: Applied on face and scalp for three days. arm 2: Applied on trunk and extremities for two days.
Interventions: intervention 1: ingenol mebutate gel 0.015% intervention 2: ingenol mebutate gel 0.05%
Intervention descriptions: intervention 1: -Face or Scalp arm (Referred to Face/Scalp arm): Apply ingenol mebutate gel 0.015% once daily for 3 consecutive days intervention 2: -Trunk or Extremities arm (Referred to Trunk/Extremities arm): Apply ingenol mebutate gel 0.05% once daily for 2 consecutive days

Protocol documents:
Clinical trial NCT02913521
Conditions: Osteoarthritis, Knee
Sponsor: Akorn, Inc.
Start date: 2015-06-01; Completion date: 2016-06-01
Enrollment: 934 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Three-Arm, Multi-Site Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Topical Gel 1% (Hi-Tech Pharmacal Co., Inc.) With Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis) in Patients With Osteoarthritis of the Knee

Detailed description:

Arms: arm 1: Apply 4 g of gel to the knee four times a day arm 2: Apply 4 g of gel to the knee four times a day arm 3: Apply 4 g of gel to the knee four times a day
Interventions: intervention 1: Diclofenac Sodium Gel 1% intervention 2: Voltaren Gel intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT03054805
Conditions: Functional Constipation
Sponsor: Chang Gung Memorial Hospital
Start date: 2014-09-01; Completion date: 2016-06-01
Enrollment: 153 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the differences of fecal microflora between constipated and non-constipated healthy children, and evaluate the efficacy of probiotics in reducing symptoms of constipation and the influence of intestinal microflora in children with functional constipation.

Detailed description:
The investigators performed a monocentric, prospective, randomized controlled trial including 120 pediatric patients (aged 6 months - 10 years old) with functional constipation and 30 healthy age-matched healthy children as control. The investigators shall evaluate the children according to the Rome III Diagnostic Criteria for functional constipation.

The 120 enrolled patients are randomized in to two groups: Group A receiving magnesium oxide and probiotics (MIYAIRI-BM), Group B receiving only magnesium oxide. Each patient is assigned the evaluation constipation symptoms and detection of microflora (beneficial and harmful bacteria) in fecal samples at the enrollment, 4 weeks, and 12 weeks. Patients who take less than 80% of the appropriate dose of medications are withdrawn from the study. All patients included in the study will be given informed oral consent before entering the study.

The data of the fecal microflora evaluated in 60 healthy children are used as control.

Arms: arm 1: Magnesium oxide 125 mg twice per day for children with weight \< 15 kg, 250 mg twice per day for weight \<15-30 kg, and 500 mg twice per day for weight \> 30 kg for 12 weeks.

MIYAIRI-BM 1 package (1g) divided as 0.5 g twice per day for children with weight \< 15 kg, 2 packages divided as 1 g twice per day for weight 15-30 kg, and 3 packages divided as 1.5 g twice per day for weight \> 30 kg for 12 weeks. arm 2: MIYAIRI-BM 1 package (1g) divided as 0.5 g twice per day for children with weight \< 15 kg, 2 packages divided as 1 g twice per day for weight 15-30 kg, and 3 packages divided as 1.5 g twice per day for weight \> 30 kg for 12 weeks. arm 3: Healthy Children
Interventions: intervention 1: Magnesium Oxide intervention 2: MIYAIRI-BM
Intervention descriptions: intervention 1: Magnesium oxide 250 mg per day for children with weight \< 15 kg, 500 mg per day for weight \<15-30 kg, and 1000 mg per day for weight \> 30 kg intervention 2: MIYAIRI-BM 1 g (1package) per day for children with weight \< 15 kg, 2g per day for weight 15-30 kg, and 3g per day for weight \> 30 kg

Protocol documents:
Clinical trial NCT03101033
Conditions: Herniated Lumbar Disc
Keywords: Herniated lumbar disc Epidural neuroplasty Epidural injection
Sponsor: yan lu
Start date: 2015-05-01; Completion date: 2016-06-01
Enrollment: 92 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether epidural neuroplasty has better efficacy than epidural steroid injection for the treatment of lumbar disc herniation.

Detailed description:
One hundred patients diagnosed as herniated lumbar disc will be recruited and divided into two groups. One group will be treated with Transforaminal steroid injection, the other with epidural neuroplasty. The VAS and ODI scores obtained at one month, three months and six months post-treatment will be analysed statistically.

Arms: arm 1: This group will be given epidural neuroplasty once enrolled. arm 2: This group will be given transforaminal betamethasone injection once enrolled, if no obvious pain relief was reported, another epidural injection will be given one week later.
Interventions: intervention 1: Mechanical epidural neuroplasty intervention 2: Transforaminal epidural compound betamethasone injection intervention 3: Caudal epidural compound betamethasone injection intervention 4: Epidural hyaluronidase injection
Intervention descriptions: intervention 1: Guided by X-ray transillumination,an epidural needle will be inserted through sacral hiatus. A catheter （BS epidural catheter, BioSpine Co., Ltd, Korea） will be inserted through the epidural needle to the epidural space where disc herniation locates, mechanical adhesiolysis will be implemented. intervention 2: Guided by X-ray transillumination, A puncture needle will be inserted to the intervertebral foramen in the vicinity of affected nerve root, and steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan®, Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected. intervention 3: steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan® Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected through the epidural catheter after mechanical epidural neuroplasty. intervention 4: Hyaluronidase of 1500 IU （Sine®, SPH NO.1 Biochemical and Pharmaceutical Co., LTD）will be injected through the epidural catheter after mechanical epidural neuroplasty and caudal epidural compound betamethasone injection.

Protocol documents:
Clinical trial NCT02498652
Conditions: Gout
Sponsor: Ardea Biosciences, Inc.
Start date: 2015-07-28; Completion date: 2016-06-02
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 2a, randomized, open-label, multicenter study to assess the pharmacodynamic (PD) effects of RDEA3170 administered in combination with allopurinol compared with allopurinol administered alone in adult subjects with gout.

Detailed description:

Arms: arm 1: RDEA3170 2.5 mg, 7.5 mg and 15 mg once daily (qd) in combination with allopurinol 300 mg (qd and twice daily (bid)) arm 2: RDEA3170 5 mg, 10 mg 20 mg qd in combination with allopurinol 300 mg (qd and bid)
Interventions: intervention 1: RDEA3170 2.5 mg intervention 2: allopurinol 300 mg
Intervention descriptions: intervention 1: Cohort 1: RDEA3170 2.5 mg, 7.5 mg (2.5 mg × 3 tablets), and 15 mg (2.5 mg × 6 tablets).

Cohort 2: RDEA3170 5 mg (2.5 mg × 2 tablets), 10 mg (2.5 mg × 4 tablets), and 20 mg (2.5 mg × 8 tablets). intervention 2: allopurinol 300 mg, allopurinol 600 mg (300 mg x 2 tablets)

Protocol documents:
Clinical trial NCT01439867
Conditions: Chronic Kidney Disease Hyperparathyroidism, Secondary
Keywords: Dialysis Sensipar Mimpara Hemodialysis Peritoneal Dialysis Renal Parathyroid hormone Pediatric
Sponsor: Amgen
Start date: 2012-06-22; Completion date: 2016-06-03
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective was to characterize corrected serum calcium levels on treatment with cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT).

Detailed description:
This is a multicenter, 26-week, single-arm, open-label, safety study. Participants were to remain on study for 26 weeks or until time of kidney transplantation, whichever came first.

The study and enrollment was placed on partial clinical hold in February 2013 which resulted in changes to the protocol. The study was restarted in April 2014 following these changes.

Participants who completed the 26-week study or were on study when the study was closed in June 2016 were eligible to participate in an open-label extension study (Study 20140159; NCT02341417).

Arms: arm 1: Prior to the partial clinical hold, the starting dose was 0.25 mg/kg (based on dry weight) and was titrated upwards (maximum allowed daily dose of 4.2 mg/kg) based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms.

After the partial clinical hold the starting dose was 0.20 mg/kg (based on dry weight) and was titrated upwards (maximum allowed daily dose of 2.5 or 60 mg, whichever was lower) based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms.

All participants also received standard of care, which may have included vitamin D sterols.
Interventions: intervention 1: Cinacalcet hydrochloride intervention 2: Standard of Care
Intervention descriptions: intervention 1: Cinacalcet was provided as 5 mg capsules that were opened, and the contents were either sprinkled on soft food or suspended into a sucrose syrup to create a liquid suspension for administration. All doses were administered with food or shortly after a meal at the same time daily. intervention 2: Standard of care may have included vitamin D sterols (25 OH vitamin D and/or 1-25 OH vitamin D and its analogs) at the discretion of the investigator.

Protocol documents:
Clinical trial NCT02273739
Conditions: Solid Tumor Glioma Angioimmunoblastic T-cell Lymphoma Intrahepatic Cholangiocarcinoma Chondrosarcoma
Keywords: solid tumor intrahepatic cholangiocarcinoma chondrosarcoma angioimmunoblastic T-cell lymphoma AITL IDH glioma solid tumor, including intrahepatic cholangiocarcinoma and chondrosarcoma
Sponsor: Celgene
Start date: 2014-12-08; Completion date: 2016-06-03
Enrollment: 21 participants; Allocation: NA; Intervention model: SEQUENTIAL

Brief summary:
The purpose of this study is to evaluate the safety, pharmacokinetics, and clinical activity of enasidenib in adults with advanced solid tumors, including glioma, or with angioimmunoblastic T-cell lymphoma (AITL), with an isocitrate dehydrogenase-2 (IDH2) mutation.

Detailed description:
The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of enasidenib to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose. The second portion of the study is a planned dose expansion phase where three cohorts of patients will receive enasidenib to further evaluate the safety, tolerability, and clinical activity. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Enrollment into the AG221-C-003 study was closed following enrollment of the dose escalation Cohort 4 (650 mg QD) in order to focus resources on the development of other pipeline IDH inhibitors in solid tumors, gliomas, and lymphoma; it was not due to safety reasons. Participants receiving enasidenib at the time of study closure were to be allowed to continue treatment until disease progression or the development of unacceptable toxicity, as outlined in the study protocol.

Arms: arm 1: During the dose escalation phase, consented eligible participants will be enrolled into sequential cohorts of increasing doses of enasidenib.The starting dose for this study is 100 mg administered every 24 hours,
Interventions: intervention 1: Enasidenib
Intervention descriptions: intervention 1: Enasidenib tablets administered orally once a day in 28-day treatment cycles until disease progression or unacceptable toxicities.

Protocol documents: