ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02420210
Conditions: Diffuse Large B-Cell Lymphoma
Sponsor: University of Chicago
Start date: 2015-11-01; Completion date: 2016-08-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well bendamustine hydrochloride, obinutuzumab, and dexamethasone work in treating older patients with diffuse large B-cell lymphoma. Drugs used in chemotherapy, such as bendamustine hydrochloride and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as obinutuzumab, may find cancer cells and help kill them. Giving bendamustine hydrochloride, obinutuzumab, and dexamethasone may kill more cancer cells.

Detailed description:
PRIMARY OBJECTIVES:

I. Assess the overall response rate (ORR; complete responders \[CR\] + partial responders \[PR\]) using the Cheson et al parameters of this novel combination regimen.

SECONDARY OBJECTIVES:

I. Assess the feasibility of incorporating prospective geriatric assessments in patients \>= 70 years of age diagnosed with diffuse large B-cell lymphoma (DLBCL) and treated in a multi-center setting.

II. Quality of life (QOL) based on Functional Assessment of Cancer Therapy-Lung (FACT-L) scale on all enrolled patients.

III. Progression-free survival (PFS) at 2 and 3 years. IV. Overall survival (OS) at 2 and 3 years.

OUTLINE:

Patients receive bendamustine hydrochloride intravenously (IV) over 30 minutes on days 1 and 2, obinutuzumab IV over 4 hours on days 1 or 2, 8, and 15 (on both days 1 and 2 in course 1 only), dexamethasone orally (PO) daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 40 months.

Arms: arm 1: Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2, obinutuzumab IV over 4 hours on days 1 or 2, 8, and 15 (on both days 1 and 2 in course 1 only), dexamethasone PO daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Bendamustine Hydrochloride intervention 2: Obinutuzumab intervention 3: Dexamethasone intervention 4: Quality-of-Life Assessment intervention 5: Laboratory Biomarker Analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Given PO intervention 4: Ancillary studies intervention 5: Correlative studies

Protocol documents:
Clinical trial NCT02449915
Conditions: Pelvic Organ Prolapse
Keywords: sacrocolpopexy rectocele repair
Sponsor: TriHealth Inc.
Start date: 2015-03-01; Completion date: 2016-08-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine if the injection of liposomal bupivacaine to laparoscopic port sites and rectocele repair incisions at the completion of a robotic sacrocolpopexy with concomitant rectocele repair will result in decreased postoperative pain compared to injection of placebo.

Detailed description:
In the last 20 years, laparoscopic surgery has assumed an important role in gynecological surgery. Unfortunately, patient surveys indicate there has been little improvement in the incidence and severity of postsurgical pain in the past two decades. Postoperative pain is a common complaint, occurring in 5-15% of patients and has been shown to significantly contribute to overall patient dissatisfaction. It can lead to increased consumption of opioids, with subsequent nausea, delayed bowel function, and prolonged postoperative recovery. In an attempt to address pain related complications with port-site wounds, various methods of pain control have been attempted. Currently, no standard of care exists and management is based on surgeon and anesthesiologist preferences.

This study seeks to determine if the injection of liposomal bupivacaine to laparoscopic port sites and rectocele repair incisions at the completion of a robotic sacrocolpopexy with concomitant rectocele repair will result in decreased postoperative pain compared to injection of placebo.

Arms: arm 1: Those subjects in the liposomal bupivacaine arm will have 30mL dilutional volume injected. Ten mL will be injected into the perineum in the posterior vaginal area and 20 mL will be injected the port site wounds in the abdomen (5 sites, 4 ml per incision). arm 2: Those subjects in the placebo arm will have 30 mL sterile normal saline injected. Ten mL will be injected into the perineum in the posterior vaginal area and 20 mL will be injected into the port site wounds in the abdomen (5 sites, 4 mL per incision).
Interventions: intervention 1: Bupivacaine intervention 2: Placebo
Intervention descriptions: intervention 1: At the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure), those subjects in the liposomal bupivacaine arm will have 30mL dilutional volume injected. Ten mL will be injected into the perineum in the posterior vaginal area and 20 mL will be injected the port site wounds in the abdomen (5 sites, 4 ml per incision). intervention 2: At the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure), those subjects in the placebo arm will have 30mL total volume injected. Ten mL will be injected into the perineum in the posterior vaginal area and 20 mL will be injected the port site wounds in the abdomen (5 sites, 4 ml per incision).

Protocol documents:
Clinical trial NCT02459899
Conditions: Type 1 Diabetes Mellitus
Sponsor: Lexicon Pharmaceuticals
Start date: 2015-07-01; Completion date: 2016-08-01
Enrollment: 141 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study was to define the dose leading to desirable efficacy, as measured by the change in hemoglobin A1C (A1C) between Baseline and Week 12.

Detailed description:

Arms: arm 1: Two placebo-matching sotagliflozin tablets, once daily, orally for 12 weeks. arm 2: Sotagliflozin 75 mg (one 75 mg tablet and one placebo tablet), once daily, orally for 12 weeks. arm 3: Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally for 12 weeks. arm 4: Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally for 12 weeks.
Interventions: intervention 1: Placebo intervention 2: Sotagliflozin
Intervention descriptions: intervention 1: Placebo, once daily, before the first meal of the day intervention 2: Sotagliflozin,once daily, before the first meal of the day

Protocol documents:
Clinical trial NCT02488070
Conditions: Recurrent Prostate Carcinoma
Sponsor: Stanford University
Start date: 2015-06-01; Completion date: 2016-08-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This clinical trial studies gallium-68 (68Ga)-prostate specific membrane antigen (PSMA) (gallium Ga 68-labeled PSMA ligand Glu-urea-Lys\[Ahx\]) positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) in identifying prostate cancer that may have returned after a period of improvement (biochemical recurrence). 68Ga-PSMA is a radiopharmaceutical that localizes to a specific prostate cancer receptor, which can then be imaged by the PET/CT or PET/MRI scanner.

Detailed description:
PRIMARY OBJECTIVES:

Evaluate the feasibility and biodistribution of 68Ga-PSMA.

OUTLINE:

Patients are injected with 5 mCi of Ga68 PSMA intravenously (IV) and then undergo PET/CT or PET/MRI approximately 45 to 60 minutes later.

After completion of study, patients are followed up at 24 hours and 1 week.

Arms: arm 1: Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.
Interventions: intervention 1: Computed Tomography intervention 2: Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx) intervention 3: Magnetic Resonance Imaging intervention 4: Positron Emission Tomography
Intervention descriptions: intervention 1: Part of PET/CT scan intervention 2: Intravenously-administered (IV) radioisotope intervention 3: Part of PET/MRI scan intervention 4: Part of PET/CT and/or PET/MRI scans

Protocol documents:
Clinical trial NCT02492841
Conditions: Caries Dental Pulp Exposure
Keywords: dentin substitute vital pulp therapy Biodentine caries
Sponsor: Universidad de los Andes, Chile
Start date: 2014-04-01; Completion date: 2016-08-01
Enrollment: 169 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Background: Dental caries is considered an oral health problem worldwide. In Chile the last national epidemiological study (2007) showed a national prevalence of dental caries in children 6 years (70.3%) and 12 (62.5%). Direct pulp capping is a preventive dental therapy, keeps the vitality of the tooth using some inductive materials mineralized tissue formation.

Objective: The main objective of this study is to evaluate the effectiveness of two innovative direct pulp capping materials; Biodentine compared MTA and calcium hydroxide in the maintenance of pulp vitality in teeth permanent molars.

Detailed description:
Methodology: It is a randomized controlled study. groups signed the informed consent for clinical trial patients, a clinical evaluation of 90 permanent molars teeth through endodontic diagnostic tests and radiograph. will be conducted to determine diagnosis. Will be assigned randomly to the type of material to use and direct pulp teeth affected by caries coating is carried out; Patients will not have knowledge of the material to be used in the coating. The patient will be clinically evaluated at 1 week, 3 months and 8 months, and radiographically; at the beginning and end of the study. In each clinical control endodontic diagnostic tests of heat, cold, electric and percussion will be performed. In radiographic controls take a radiograph control with positioner or surveyor at baseline and 8 months, to evaluate the periapical status. Clinical success will consider that tooth in continuous controls and after 8 months presented vitality and radiographic signs of apical image without injury. Failure unresponsive to consider whether susceptibility testing of cold and electricity in more than one control and presents radiographic image with apical lesion.

Arms: arm 1: Mineral trioxide aggregate Root canal repair material arm 2: -material for pulp capping arm 3: Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping
Interventions: intervention 1: Mineral trioxide aggregate intervention 2: Calcium hydroxide intervention 3: Biodentine
Intervention descriptions: intervention 1: Mineral trioxide aggregate intervention 2: Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material. intervention 3: Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution.

Protocol documents:
Clinical trial NCT02492984
Conditions: Hemophilia A
Keywords: FVIII inhibitor
Sponsor: Pfizer
Start date: 2015-04-01; Completion date: 2016-08-01
Enrollment: 85 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
An open-label, single-arm, post- authorization pragmatic clinical trial on the safety and efficacy of Xyntha (Moroctocog-alfa (AF-CC), Recombinant FVIII) in subjects with hemophilia A in usual care settings in China for approximately 6 months or or approximately 50 exposure days whichever occurs first

Detailed description:
The purpose of this post-approval study is to provide supplementary information relating to the use of Xyntha (Moroctocog-alfa (AF-CC), Recombinant FVIII) in Chinese subjects with hemophilia A, especially on the safety and efficacy in different populations of Chinese hemophilia A patients, in particular in pediatric patients \<6 years of age, pediatric patients ≥6 to ≤12 years of age, Previously Untreated Patients (PUPs) , subjects receiving prophylaxis treatment after enrollment in the study, and severe patients (FVIII:C \<1%).

Arms: arm 1: Enrolled subjects will be treated with intravenous infusions of Xyntha for: • On-Demand treatment, • Surgical Prophylaxis at a dose and frequency prescribed by the subject's treating physician in accordance with the Xyntha label and will be adjusted solely according to medical and therapeutic necessity.
Interventions: intervention 1: Intravenous infusions of Xyntha
Intervention descriptions: intervention 1: Enrolled subjects will be treated with intravenous infusions of Xyntha for: • On-Demand treatment, • Surgical Prophylaxis at a dose and frequency prescribed by the subject's treating physician in accordance with the Xyntha label and will be adjusted solely according to medical and therapeutic necessity.

Protocol documents:
Clinical trial NCT02515656
Conditions: Vaginitis
Sponsor: Laboratoire Innotech International
Start date: 2015-09-01; Completion date: 2016-08-01
Enrollment: 661 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
POLYGYNAX® is a broad spectrum combination of nystatin, neomycin and polymixin B indicated for the local treatment of vaginitis due to sensitive germs and treatment of non specific vaginitis of adults. POLYGYNAX® has been marketed in France since 1969.

Nevertheless, despite the well established use of POLYGYNAX®, there is no clinical study supporting the interest of the combination of antifungal and antibiotics agents versus antifungal agent alone.

The aim of this project is to demonstrate that POLYGYNAX® is more effective than miconazole in the treatment of women experiencing symptoms of infectious vaginitis.

Detailed description:

Arms: arm 1: Name : POLYGYNAX® Active components : nystatin 100 000 IU + neomycin sulphate 35 000 IU + polymyxin B sulphate 35 000 IU Dosage : 1 capsule intravaginally per day (administered at bedtime lying down) 12 vaginal soft capsules arm 2: Name : GYNODAKTARIN® Active components : miconazole nitrate 400 mg Dosage : 1 capsule intravaginally per day (administered at bedtime, lying down) 3 vaginal soft capsules followed by 9 placebo vaginal soft capsules
Interventions: intervention 1: POLYGYNAX® intervention 2: GYNODAKTARIN® intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02535416
Conditions: Healthy
Sponsor: Arrowhead Pharmaceuticals
Start date: 2015-09-01; Completion date: 2016-08-01
Enrollment: 40 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Single doses of ARC-520 will be evaluated at varying infusion rates and by slow bolus push.

Detailed description:
This is a single-center, open-label, sequential cohort, single-dose study of ARC-520 administered intravenously to healthy adult volunteers. Eligible subjects will receive a single intravenous injection of ARC-520. Up to 8 cohorts (a total of approximately 40 subjects) may be enrolled. ARC-520 (4.0 mg/kg) will be administered at increasing infusion rates up to a bolus push in cohort 5. In addition dose levels at 5.0 mg/kg and 6.0 mg/kg will be evaluated at an infusion rate of 0.9 mL/min. For each subject the duration of the study clinic visits is approximately 6 weeks; maximum study duration is approximately 17 weeks including follow-up telephone calls at Days 30, 60 and 90.

Participants will undergo the following evaluations at regular intervals: medical history, physical examinations, bee venom allergy blood test, vital signs measurements, weight, adverse event monitoring, electrocardiograms (ECGs), telemetry, pregnancy test (females), concurrent medication, blood sample collection for hematology, coagulation, chemistry, pharmacokinetics, pharmacodynamics, and drug screens, and urinalysis.

Arms: arm 1: Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.6 mL/min + cetirizine arm 2: Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + cetirizine arm 3: Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.75 mL/min + diphenhydramine arm 4: Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine arm 5: Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.2 mL/min + diphenhydramine arm 6: Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.5 mL/min + diphenhydramine arm 7: Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine arm 8: Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine arm 9: Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine
Interventions: intervention 1: ARC-520 intervention 2: cetirizine intervention 3: diphenhydramine
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02554877
Conditions: Type 2 Diabetes Mellitus
Sponsor: Pfizer
Start date: 2015-10-01; Completion date: 2016-08-01
Enrollment: 206 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether PF-06291874 is effective in the treatment T2DM

Detailed description:
This will be a randomized, double blind, stratified, placebo controlled, parallel group study conducted in T2DM subjects receiving background metformin therapy. Subjects will complete screening procedures to determine eligibility, followed by an 8 week metformin stabilization period prior to randomization. In addition, subjects taking other OADs, in combination with metformin, will undergo a washout during this period, in which non metformin OAD medications will be temporarily discontinued for the duration of the trial. Following confirmation of study eligibility criteria at randomization, subjects will be stratified into 2 groups based on the use of concomitant statin therapy. Each stratum will be randomized across treatment groups, such that the number of subjects taking concomitant statin therapy and those not taking statin therapy will be approximately balanced across treatment groups.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: PF-06291874 intervention 2: Placebo
Intervention descriptions: intervention 1: study drug to be given as an oral tablet at 30, 60 or 100 mg intervention 2: oral tablet

Protocol documents:
Clinical trial NCT02565381
Conditions: Smoking
Sponsor: Massachusetts General Hospital
Start date: 2015-10-01; Completion date: 2016-08-01
Enrollment: 83 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The QUIT (Quitting with Usual Care, Incentives, and Technology) Smoking Study is a 3-arm pilot randomized controlled trial that will test the effect of 2 different experimental smoking cessation interventions relative to a control condition in homeless cigarette smokers. All participants will receive free transdermal nicotine patches and weekly in-person smoking cessation counseling. In addition, participants randomized to the first experimental condition will receive financial rewards for biochemically-verified smoking abstinence, and participants randomized to the second experimental condition will be enrolled in a text messaging program to support smoking abstinence.

Detailed description:

Arms: arm 1: * Transdermal nicotine patch
* In-person smoking cessation counseling arm 2: * Transdermal nicotine patch
* In-person smoking cessation counseling
* Contingent financial rewards for smoking abstinence arm 3: * Transdermal nicotine patch
* In-person smoking cessation counseling
* Text messages to support smoking abstinence
Interventions: intervention 1: Transdermal nicotine patch intervention 2: In-person smoking cessation counseling intervention 3: Contingent financial rewards for smoking abstinence intervention 4: Text messages to support smoking abstinence
Intervention descriptions: intervention 1: * ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
* \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks intervention 2: \- One-on-one 15-minute counseling sessions once per week for 8 weeks intervention 3: \- Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide \<8ppm intervention 4: \- 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT

Protocol documents:
Clinical trial NCT02569437
Conditions: Polyp of Nasal Sinus
Keywords: doxycycline oral methylprednisone sinusitis with nasal polyps
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2014-09-01; Completion date: 2016-08-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The Department of Otolaryngology at Mount Sinai is looking for adults with sinus disease with polyps, otherwise called chronic rhinosinusitis with nasal polyps (CRSwNP). Patients may be eligible to enroll in a study offering a cutting-edge therapy to help reduce symptoms and avoid surgery. The treatment combines an antibiotic (doxycycline) with oral steroids. Oral steroids are the mainstay of medical management for patients with CRSwNP. However, recent studies have shown that doxycycline helps improve symptoms as well by reducing inflammation and killing common bacteria that can cause symptoms. This study is the first to evaluate this combination regimen.

Detailed description:
An eligible patient may be treated with either doxycycline and oral steroids OR placebo (sugar pill) and oral steroids for three weeks. Volunteers will participate in the study for to 12 weeks, and will have 4 research visits of 1 hour duration. At each study visit, the patient will under go an endoscopic evaluation and asked to complete a questionnaire describing symptoms. There is no additional cost to be enrolled in the study.

Arms: arm 1: Doxycycline plus oral methylprednisolone and nasal saline sprays arm 2: placebo pill plus oral methylprednisolone for three weeks. After this, maintenance therapy which includes nasal saline sprays and daily nasal steroid sprays.
Interventions: intervention 1: Doxycycline intervention 2: methylprednisolone intervention 3: nasal saline spray intervention 4: Flonase intervention 5: sugar pill
Intervention descriptions: intervention 1: Doxycycline (200 mg PO X 1 dose on Day 1, then 100 mg PO daily) for Day 2-20 intervention 2: oral methylprednisolone: 32 mg x 5 days, 16 mg x 5 days, 8 mg x 10 days intervention 3: nasal saline sprays: 2 sprays each nostril three times a day intervention 4: daily nasal steroid sprays (Flonase, 2 sprays each nostril daily). intervention 5: placebo pill to match doxycycline

Protocol documents:
Clinical trial NCT02573311
Conditions: Urological Manifestations
Sponsor: Boehringer Ingelheim
Start date: 2015-09-23; Completion date: 2016-08-01
Enrollment: 1117 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
An actual use study to assess how men who respond to advertisements about urinary symptoms use tamsulosin in a simulated Over the Counter (OTC) setting including following "stop use and ask a doctor if" and "ask a doctor before use" statements and if they take the medication according to the label instructions, also assess any reported adverse events during simulated OTC use.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: tamsulosin hydrochloride
Intervention descriptions: intervention 1: None

Protocol documents: