ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00970073
Conditions: Liver Transplantation
Keywords: calcineurin inhibitor delay Kidney
Sponsor: The Cleveland Clinic
Start date: 2009-08-01; Completion date: 2015-12-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the use of a drug called Thymoglobulin, combined with a delayed start of the anti-rejection drugs (10 days after liver transplant), compared to the current approach of starting anti-rejection drugs called calcineurin inhibitors or CNI's within 2 days after the liver transplant.

Detailed description:
Strong anti-rejection drugs like tacrolimus or cyclosporine, are given to patients who have received transplants, to ensure that the patient's body does not reject the new organ. In some cases, while anti-rejection medications protect a newly transplanted liver, they can injure the patient's kidneys and cause them not to work as well as they should. The purpose of this pilot study is to determine the best way to protect kidney function and to ensure that the newly transplanted liver is not rejected. This study will evaluate the use of a drug called Thymoglobulin, combined with a delayed start of the anti-rejection drugs (10 days after liver transplant), compared to the current approach of starting anti-rejection drugs called calcineurin inhibitors or CNI's within 2 days after the liver transplant.

Arms: arm 1: Thymoglobulin 3mg total, administered on Days 0 and 2 (after transplant), plus MMF and corticosteroids. CNI administration delayed until 10 days post transplant. tacrolimus 3-8 (trough concentration) arm 2: Thymoglobulin 4.5mg total, plus MMF and corticosteroids. CNI therapy delayed until 10 days post transplant.tacrolimus 3-8 (trough concentration) arm 3: Standard post liver transplant therapy to include: tacrolimus 8-12 (trough concentration) initiated within 48 hours post-transplant, plus mycophenolate mofetil (MMF) and corticosteroids to be administered within 24 hours after transplant (Day 0).
Interventions: intervention 1: Thymoglobulin 3mg total intervention 2: Thymoglobulin 4.5mg total intervention 3: Mycophenolate mofetil intervention 4: tacrolimus 3-8 intervention 5: tacrolimus 8-12
Intervention descriptions: intervention 1: 1.5 mg/kg induction on Day 0 and 1.5 mg/kg induction on Day 2 (total of 3 mg/kg) intervention 2: 1.5 mg/kg induction on Days 0, 2 and 4 (total 4.5 mg/kg) intervention 3: 1000 mg PO/IV BID for up to 6 months intervention 4: Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180 intervention 5: Trough concentration between 8 ng/mL and 12 ng/mL on Days 0-10; between 6 ng/mL and 12 ng/mL on Days 10-30; between 6 ng/mL and 10 ng/mL Days 31-60; between 5 ng/mL and 8 ng/mL Days 61-179; and between 3 ng/mL and 8 ng/mL beyond Day 180.

Protocol documents:
Clinical trial NCT01050647
Conditions: Pregnancy Complications
Sponsor: Stanford University
Start date: 2010-02-01; Completion date: 2015-12-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Preterm birth is the leading cause of neonatal death and a significant cause of life long disability and health problems. It has been shown that the drug 17-hydroxyprogesterone caproate can help reduce the risk of preterm delivery in women with certain risk factors for preterm birth. We hope to learn whether this same medication can be used to prolong pregnancy in a group of patients in whom this medication has not been previously studied. Specifically, we hope to learn whether progesterone supplementation will delay delivery in women with pre-term, premature rupture of membranes (PPROM).

Detailed description:
When women present to either the Obstetrical clinic or labor and delivery with a complaint of possible preterm, premature rupture of membranes (PPROM), they will be examined by an obstetrician to either confirm or rule out this diagnosis. If they are diagnosed with PPROM, they will then be admitted to Lucile Packard Children's Hospital and treated with the normal protocol which includes receiving antibiotics, receiving steroids, being hospitalized until delivery, and having ongoing maternal and fetal monitoring for possible complications. The patients will be identified by their treating obstetricians as possible study candidates and asked by a member of the treatment team if they are potentially interested in participating in a research study. Subsequently, a member of the study team or the treating physician will approach the patient about participating in the trial. Those who choose to participate will receive the standard care protocol in addition to receiving the study medication. The study medication will be a weekly injection of either placebo or 17-hydroxyprogesterone caproate or placebo. The placebo medication (castor oil) was chosen as it has been used in previous studies as a placebo for 17-hydroxyprogesterone caproate. The choice of which medication the patient receives will be determined by a randomization table. Only the pharmacist will be aware of the medication that has been administered. The patient, members of the treatment team, and members of the study team will be blinded to the medication that is being administered. The timing of their delivery will be managed by the treating obstetrician according to standard medical practice. After delivery, the patient's and her infant's medical outcomes will be recorded for analysis.

Arms: arm 1: Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation arm 2: Weekly injections of Caster Oil (placebo)
Interventions: intervention 1: 17-Hydroxyprogesterone Caproate intervention 2: Caster Oil injections
Intervention descriptions: intervention 1: Weekly injections of 17-hydroxyprogesterone caproate. intervention 2: Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation.

Protocol documents:
Clinical trial NCT01100255
Conditions: Obsessive-Compulsive Disorder
Keywords: OCD
Sponsor: New York State Psychiatric Institute
Start date: 2010-04-01; Completion date: 2015-12-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
In this study investigators are studying the effects of a drug called ketamine on the symptoms of Obsessive-compulsive disorder (OCD).

Detailed description:
Obsessive-compulsive disorder (OCD) is a common psychiatric illness that affects up to 2-3% of the population. People with OCD experience anxiety-provoking, intrusive thoughts, known as obsessions, and feel compelled to perform repetitive behaviors, or compulsions. The only medications proven effective for OCD are serotonin reuptake inhibitors (SRIs), but even with SRI treatment, most patients continue to experience significant OCD symptoms, impaired functioning, and diminished quality of life. Recent evidence suggest that a different neurotransmitter, glutamate, may contribute to the symptoms in OCD. Medications that target glutamate hold promise for ameliorating symptoms for those patients continuing to suffer from OCD. In this study the investigators are recruiting patients to receive the drug ketamine, which is thought to modulate the neurotransmitter glutamate through the N-methyl-D-aspartate (NMDA), in a 2-week placebo controlled study.

Arms: arm 1: 0.5mg/kg IV ketamine infusion over 40 minutes then IV saline infusion over 40 minutes arm 2: IV saline infusion over 40 minutes then 0.5mg/kg IV ketamine infusion over 40 minutes
Interventions: intervention 1: Ketamine infusion intervention 2: Saline
Intervention descriptions: intervention 1: 0.5mg/kg IV over 40 minutes intervention 2: saline infusion

Protocol documents:
Clinical trial NCT01102231
Conditions: Stage III Non-small Cell Lung Cancer
Sponsor: Intergroupe Francophone de Cancerologie Thoracique
Start date: 2010-03-01; Completion date: 2015-12-01
Enrollment: 106 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Radiochemotherapy is a standard for the treatment of unresectable stage III non-small cell lung cancer. The investigators goal is to study the efficacy and the toxicity for a promising association of new agents (cetuximab and pemetrexed) with concurrent radiotherapy.

Detailed description:

Arms: arm 1: Chemoradiotherapy
Interventions: intervention 1: Chemotherapy intervention 2: ERBITUX intervention 3: Radiotherapy
Intervention descriptions: intervention 1: Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles) intervention 2: The initial dose of cetuximab (ERBITUX) is 400 mg/m² intravenously administered over 120 minutes, followed by 11 weekly infusions at 250 mg/m² IV over 60 minutes intervention 3: 66 Gy (2 Gy by fraction, 5 fractions by week)

Protocol documents:
Clinical trial NCT01117454
Conditions: Catecholaminergic Polymorphic Ventricular Tachycardia
Keywords: Catecholaminergic Polymorphic Ventricular Tachycardia implantable cardioverter-defibrillator flecainide
Sponsor: Vanderbilt University Medical Center
Start date: 2011-12-01; Completion date: 2015-12-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to test whether the addition of oral flecainide to standard therapy will reduce ventricular ectopy on exercise test compared to placebo plus standard therapy in patients with Catecholaminergic Polymorphic Ventricular Tachycardia.

Detailed description:
Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) is a genetic arrhythmia syndrome characterized by frequent ventricular ectopy and polymorphic, classically bidirectional ventricular tachycardia with physical or emotional stress, which also carries a risk of ventricular fibrillation and sudden death, despite no structural heart abnormality. Treatment consists of beta-blockers and/or calcium channel blockers, but up to 30% of patients require implantable cardioverter-defibrillators (ICDs) due to recurrent symptoms on medical therapy. In an animal model, flecainide was found to directly target the molecular defect in CPVT. In a retrospective clinical study in patients with CPVT we have seen improvement of ventricular ectopy on exercise tests when flecainide is added to standard therapy. We propose a prospective trial of flecainide added to standard therapy in CPVT patients to test the hypothesis that flecainide will reduce ventricular ectopy on exercise testing compared to placebo plus standard therapy.

This will be a single-blind (blinded subjects) randomized cross-over study, in which each patient will receive treatment A (flecainide or placebo) for at least 3 months and, after a 1 week wash-out, treatment B (placebo or flecainide) for at least 3 months.

Arms: arm 1: In this crossover study, half of the subjects will be randomized to flecainide plus standard therapy with beta-blockers first, then crossover to placebo plus standard therapy with beta-blockers. arm 2: In this crossover study, half of the subjects will be randomized to placebo plus standard therapy with beta-blockers first, then crossover to flecainide plus standard therapy with beta-blockers.
Interventions: intervention 1: Flecainide Acetate intervention 2: Placebo intervention 3: Beta blocker
Intervention descriptions: intervention 1: oral flecainide with the dose titrated to achieve a serum level between 0.5-0.8 mcg/ml intervention 2: placebo, similar in appearance to flecainide intervention 3: Standard therapy with beta-blocker (nadolol, atenolol, metoprolol, or propranolol) continues throughout the trial.

Protocol documents:
Clinical trial NCT01139164
Conditions: Hematological Malignancies
Keywords: high-risk hematological malignancies
Sponsor: Medical University of South Carolina
Start date: 2010-06-01; Completion date: 2015-12-01
Enrollment: 78 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is study is for patients that have been diagnosed with high-risk hematological malignancies. The main purpose of this study is to confirm previously published results of stem cell transplantation with reduced intensity pre-transplant conditioning. Patients will be assigned to 1 of 3 regimens depending on the patient's diagnosis. Participants will be followed by the transplant team for the remainder of the patient's life. Patient's will visit MUSC daily, then visits will be reduced to frequent visits for up to 6 months. After 6 months, the visits will be reduced more depending on the patient's condition.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Regimen A intervention 2: Regimen B intervention 3: Regimen C
Intervention descriptions: intervention 1: Chronic Lymphocytic Leukemia/ Chronic Prolymphocytic Leukemia, Multiple Myeloma. intervention 2: Other malignancies not addressed in A or C intervention 3: B-Cell Lymphomas

Protocol documents:
Clinical trial NCT01211756
Conditions: Major Depressive Disorder Dysthymia Disorder
Sponsor: David Feifel
Start date: 2010-10-01; Completion date: 2015-12-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of the study is to compare the efficacy of intranasal oxytocin versus intranasal placebo to improve depression symptoms in patients with Major Depressive Disorder (MDD) or Dysthymia Disorder.

Detailed description:
Depression patients treated with even the best currently available antidepressant drugs continue to experience significant symptoms. There is a strong need for better treatments including treatments that can safely be given adjunctively with concurrent antidepressants in order to improve overall efficacy of treatment.

Oxytocin is a neurohypophyseal peptide best known for its role as a neurohormone involved in parturition and lactation. In addition to these well established peripheral effects, there is a compelling body of converging evidence indicating that oxytocin plays a critical role in the regulation of a number of diverse centrally-mediated behavioral and cognitive processes that are highly relevant to mood regulation and mood disorders, including social attachment (Argiolas and Gessa 1990; McCarthy and Aaltemus 1997).

Each subject will be enrolled for a 8 week treatment period after a screening phase. Study procedure involves weekly clinic visits as an outpatient. Twenty patients will be randomly assigned to either 40 IU oxytocin twice daily or vehicle placebo. After 4 weeks, treatments will be crossed over such that subjects that received oxytocin will receive placebo and vice versa. The study ratio is 1:1. Dose of oxytocin is based upon previous studies in humans showing improvement in psychiatric populations related changes in behavior and brain function (Kosfeld et al, 2005; Kirsch 2005; Heinrich M 2003).

The total study duration for each individual subject will be approximately 9 weeks, which includes up to 31-day screening period, a baseline (randomization) visit, four week treatment period, 1 week washout, baseline 2 visit, and four weeks cross over treatment.

Arms: arm 1: 20 IU of intranasal oxytocin twice per day for the first week, 40 IU of intranasal oxytocin twice per day for the following 3 weeks, one week wash out, 4 week placebo trial. arm 2: Four week placebo trial, one week wash out, 20 IU of intranasal oxytocin twice per day for one week, 40 IU of intranasal oxytocin twice per day for 3 weeks.
Interventions: intervention 1: Oxytocin intervention 2: Placebo
Intervention descriptions: intervention 1: 20 IU BID for one week, followed by 40 IU BID for 3 weeks. intervention 2: 20 IU BID for one week, followed by 40 IU BID for 3 weeks.

Protocol documents:
Clinical trial NCT01233609
Conditions: Retinitis Pigmentosa
Keywords: retinitis pigmentosa valproic acid visual field
Sponsor: Foundation Fighting Blindness
Start date: 2010-11-01; Completion date: 2015-12-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this study are to evaluate the efficacy of Valproic Acid (VPA) to both slow the progression of visual function loss and/or to restore visual function in patients with Autosomal Dominant Retinitis Pigmentosa (RP) and to collect safety and tolerability information.

Detailed description:
Retinitis Pigmentosa (RP) is an incurable and untreatable group of heterogeneous retinal degenerative diseases that cause severe visual loss. There is currently no therapeutic that substantially slows the progression of this disease, and certainly none that can restore vision in RP patients. The Valproic Acid (VPA) study is designed as a six-site, interventional, prospective, randomized, placebo controlled, double-blinded study of 90 participants to evaluate the efficacy of oral Valproic Acid to both slow the progression of visual function loss and/or to restore visual function in patients with an Autosomal Dominant RP genetic mutation and to collect safety and tolerability information. Patients that participate in the study will be randomized to either placebo or VPA in a 1:1 ratio.

Arms: arm 1: Subjects who receive valproic acid arm 2: Subjects who receive placebo
Interventions: intervention 1: Valproic Acid intervention 2: Placebo
Intervention descriptions: intervention 1: One to four 250mg softgels by mouth daily (dose determined by body weight) intervention 2: Dosage per subject weight- same schedule as the active comparator

Protocol documents:
Clinical trial NCT01235546
Conditions: Endometritis Wound Infection Abscess Surgical Site Infection
Keywords: Pregnancy Cesarean section Antibiotic Infections
Sponsor: Alan Tita
Start date: 2011-05-01; Completion date: 2015-12-01
Enrollment: 2013 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The Cesarean Section Optimal Antibiotic Prophylaxis (C/SOAP) study is a large pragmatic multi-center randomized clinical trial designed to evaluate the comparative effectiveness and safety of azithromycin-based extended-spectrum antibiotic prophylaxis (azithromycin plus standard narrow-spectrum cephalosporin) relative to standard single-agent cephalosporin (preferably prior to surgical incision) to prevent post-cesarean infection.

Hypothesis: Compared to narrow-spectrum prophylaxis (i.e. cefazolin alone, or clindamycin if cephalosporin allergy) prior to surgical incision, the addition of extended-spectrum prophylaxis (azithromycin + cefazolin) reduces the incidence of post-cesarean infection.

Detailed description:

Arms: arm 1: 250 cc normal saline arm 2: 500 mg Azithromycin in 250 cc normal saline
Interventions: intervention 1: Azithromycin and standard of care intervention 2: Placebo and standard of care
Intervention descriptions: intervention 1: 500 mg in 250 cc normal saline 1 time dose plus standard of care (cephazolin or clindamycin) intervention 2: 250 cc normal saline, plus standard of care (cephazolin or clindamycin)

Protocol documents:
Clinical trial NCT01259388
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis Lithium
Sponsor: VA Office of Research and Development
Start date: 2011-05-01; Completion date: 2015-12-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine whether lithium carbonate is safe, well-tolerated, and effective at treating progressive forms of multiple sclerosis.

Detailed description:
In progressive multiple sclerosis (MS), patients experience worsening disability through a combination of inflammatory and neuro-degenerative processes. To test whether low-dose lithium carbonate ameliorates disability accumulation in progressive MS, patients with progressive MS were randomly assigned to take lithium in either the first or second year of a two-year trial. The trial was designed as a cross-over study to maximize exposure to lithium to for two reasons: 1) To increase the number of persons with MS exposed to lithium for purposes of assessing safety and tolerance; and 2) To increase the power to detect changes in the primary radiological outcome (change in brain volume) and also in secondary clinical outcomes (disability, mood, fatigue, cognition).

Arms: arm 1: Lithium-treatment phase

Lithium Carbonate: Lithium carbonate is dosed at 150 or 300 mg daily, as tolerated by study subjects, for one year's time. arm 2: During observation subjects continue on their standard of care disease modifying agent (or no agent at all if judged not appropriate by the treating physician).
Interventions: intervention 1: Lithium Carbonate
Intervention descriptions: intervention 1: Lithium carbonate is dosed at 150 or 300 mg daily, as tolerated by study subjects, for one year's time.

Protocol documents:
Clinical trial NCT01272830
Conditions: Edematous Synovitis Foreign Body Reaction Osteolysis
Keywords: total joint arthroplasty synovitis ALVAL (Aseptic Lymphocyte-Dominant Vasculitis-Associated Lesion) osteolysis periprosthetic metallosis
Sponsor: IC-MedTech Corporation
Start date: 2010-10-01; Completion date: 2015-12-01
Enrollment: 57 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research study is being conducted to determine if taking oral (by mouth in pill form) Apatone®B (a combination of Vitamins C and K3) will reduce chronic joint discomfort and improve function of non-infected symptomatic postoperative total joint replacements.

Detailed description:
To perform a prospective, randomized, double-blind clinical trial to determine if oral Apatone®B, an amalgam of vitamins C and K3, has a therapeutic efficacy beyond the conservative care customarily used to reduce inflammatory synovitis and to increase the functional capacity of proven non-infected symptomatic postoperative total joint replacements.

Arms: arm 1: An amalgam of Vitamins C \& K3 arm 2: Oral capsule of similar appearance and taste without Apatone®B
Interventions: intervention 1: Placebo intervention 2: Apatone®B
Intervention descriptions: intervention 1: Two capsules taken twice daily with meals intervention 2: Two capsules taken twice daily with meals

Protocol documents: