ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01032083
Conditions: Schizophrenia
Keywords: SSRI antidepressant Negative symptoms Schizophrenia
Sponsor: Imperial College London
Start date: 2011-07-01; Completion date: 2015-01-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this double-blind, placebo-controlled trial is to establish the clinical and cost effectiveness of an SSRI antidepressant, citalopram, in the management of persistent negative symptoms of schizophrenia over a year.

Detailed description:
The negative symptoms of schizophrenia represent an important dimension of psychopathology, and reflect the absence or diminution of normal behaviours and functions. They include deficiencies in emotional responsiveness, drive, and emotional and social engagement. Persistent negative symptoms are held to account for much of the long-term morbidity and poor functional outcome in patients with established schizophrenia, but if they prove resistant to antipsychotic medication there is a very limited evidence base regarding specific treatments. The aim of this double-blind, placebo-controlled trial is to establish the clinical and cost effectiveness of an SSRI antidepressant, citalopram, in the management of negative symptoms of schizophrenia over a year. The study sample will be adults with a diagnosis of schizophrenia, clinically stable for 3 months with a consistent antipsychotic regimen, and characterised by persistent negative symptoms to a criterion level of severity.

Arms: arm 1: An SSRI antidepressant arm 2: None
Interventions: intervention 1: Citalopram intervention 2: Placebo
Intervention descriptions: intervention 1: Treatment with citalopram will be initiated at 20mg/day for the first 4 weeks (or one placebo capsule), followed by the option to increase the dose to 40mg per day (or two placebo capsules) for the remainder of the study period. intervention 2: Treatment with citalopram will be initiated at 20mg/day for the first 4 weeks (or one placebo capsule), followed by the option to increase the dose to 40mg per day (or two placebo capsules) for the remainder of the study period.

Protocol documents:
Clinical trial NCT01032759
Conditions: Pain
Sponsor: Duke University
Start date: 2009-12-01; Completion date: 2015-01-01
Enrollment: 77 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Memantine is associated with improvement in pain relief after surgery.

Detailed description:
This prospective, randomized, controlled trial will investigate whether perioperative memantine has a postoperative analgesic effect following radical retropubic prostatectomy (RRP). 100-110 patients scheduled to undergo RRP at Duke will be assessed preoperatively for allodynia using Von Frey filaments, then stratified into two groups based on the presence or absence of allodynia. Patients in each group will then be randomized to receive either memantine 20 mg or placebo 30-60 minutes preoperatively, followed on postoperative day 1 with either memantine 10 mg in the morning and 10 mg in the evening for memantine patients, or placebo at the same intervals for placebo patients. Data such as morphine consumption, patient satisfaction and pain scores, opioid-related side effects, and the area of hyperalgesia around the surgical incision will be recorded for the initial 48 hours postoperatively, and patient satisfaction with their postoperative analgesia will be assessed after 1 week. At 1, 3, and 6 months postoperatively, patients will be asked about the presence and intensity of any persistent pain related to surgery.

Arms: arm 1: None arm 2: Placebo
Interventions: intervention 1: Memantine intervention 2: Placebo
Intervention descriptions: intervention 1: 20 mg, BID intervention 2: BID

Protocol documents:
Clinical trial NCT01056523
Conditions: Acute Myeloid Leukemia
Keywords: AML
Sponsor: Jewish General Hospital
Start date: 2010-01-01; Completion date: 2015-01-01
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to determine the maximum tolerated dose of ribavirin, when given in combination with low-dose ara-C and to determine if it is safe and well-tolerated in patients with acute myeloid leukemia.

Detailed description:
Primary Objectives

In the Phase I portion of this study, we will determine the maximum tolerated dose and recommended phase II dose (RP2D) of ribavirin and low-dose ara-C. The primary objective of the Phase II portion of the study is to determine the overall response rate, including the complete remission (CR), complete remission with incomplete blood count recovery (CRi), partial remission (PR) or blast response (BR), to therapy with ribavirin and low dose ara-C at the RP2D.

STUDY DESIGN AND DURATION

This is a multicentre, open-label, single arm Phase I/II study of oral ribavirin and low-dose ara-C for patients with AML M4/M5 or AML with high expression of eIF4E, who have relapsed or refractory disease, or who are not suitable candidates for induction chemotherapy. This study will determine the recommended phase II dose and will evaluate efficacy. Correlative studies will be included to assess relevant molecular targets.

Arms: arm 1: Ribavirin will be given orally bid according to a dose escalation scheme daily for 28 days of a 28 day cycle Cytarabine arabinoside will be given 20 mg sc bid days 1 to 10 of a 28 day cycle
Interventions: intervention 1: Ribavirin intervention 2: Cytarabine arabinoside
Intervention descriptions: intervention 1: Dose level 1 = 1000 mg po BID/ Dose level 2 = 1400 mg po BID/ Dose level 3 = 1800 mg po BID intervention 2: Previous cohorts at 20 mg bid days 1 to 10 of every 28 day cycle. Dosage modified to 10 mg bid days 1 to 10 of every 28 day cycle for more recent cohorts.

Protocol documents:
Clinical trial NCT01119131
Conditions: Parkinson Disease Accidental Falls
Keywords: Vitamin D Parkinson disease accidental falls
Sponsor: VA Office of Research and Development
Start date: 2011-05-01; Completion date: 2015-01-01
Enrollment: 101 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A trial to measure the effects of vitamin D (versus a placebo) on balance, gait, falls, strength, and cognition in persons with Parkinson's disease.

Detailed description:
The proposed study is a randomized, double-blinded, placebo controlled intervention trial to measure the effects of vitamin D at (10,000IU/day) versus placebo on balance and falls in Parkinson's disease. The investigators will measure static, dynamic, and ambulatory balance, as well as strength, falls, and cognition before and after 16 weeks of therapy. Dynamic posturography will be used to measure static and ambulatory balance, a device called iMOBILITY will measure a timed up and go, and strength will be measured with the Biodex machine checking knee flexion and extension. Multiple quality of life and cognitive tests will also be performed.

Arms: arm 1: Will be on high dose vitamin D3 (10,000 IU daily) and 1000 mg of calcium arm 2: Will be on placebo and 1000mg of calcium.
Interventions: intervention 1: Vitamin D3 intervention 2: calcium intervention 3: Placebo
Intervention descriptions: intervention 1: Vitamin D3 at 10,000 IU a day intervention 2: 1000mg calcium daily intervention 3: A placebo pill with similar appearance to the vitamin D3 will be given to those in the placebo arm

Protocol documents:
Clinical trial NCT01133678
Conditions: Head and Neck Cancer
Keywords: Squamous Cell Carcinoma
Sponsor: University of Chicago
Start date: 2010-05-04; Completion date: 2015-01-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary

Compare response rates (relative change in tumor size) to induction chemotherapy consisting of cisplatin/paclitaxel/cetuximab +/- everolimus.

Secondary:

Determine the maximum administered dose (MAD), maximum tolerated dose (MTD), dose limiting toxicity (DLT), and safety of everolimus with cisplatin/paclitaxel/cetuximab induction chemotherapy (phase I portion)

Detailed description:
Results reported here are for the randomized, phase II portion of the trial.

Arms: arm 1: Everolimus 5 mg PO Daily for 2 21-day cycles arm 2: Placebo 5 mg PO Daily for 2 21-day cycles
Interventions: intervention 1: Everolimus intervention 2: Placebo
Intervention descriptions: intervention 1: Phase II Portion (2 21-day cycles of induction therapy) Cisplatin (75 mg/m2 day 1) Paclitaxel (175 mg/m2, day 1) Cetuximab(400 mg/m2 loading dose day 1 then 250mg/m2 weekly ) Everolimus 5 mg PO daily. Following induction patients received \[paclitaxel (100 mg/m2 IV weekly), 5-FU (600 mg/m2 IV day 1-5), hydroxyurea 500 mg BID PO (day 1-5), and hyperfractionated twice daily radiotherapy (150 cGy per fraction) day 1-5 of a 14 day cycle which is repeated to deliver the prescribed radiotherapy dose. intervention 2: Phase II Portion (2 21-day cycles of induction therapy) Cisplatin (75 mg/m2 day 1) Paclitaxel(175 mg/m2, day 1) Cetuximab(400 mg/m2 loading dose day 1 then 250mg/m2 weekly ) Placebo PO daily. Following induction patients received \[paclitaxel (100 mg/m2 IV weekly), 5-FU (600 mg/m2 IV day 1-5), hydroxyurea 500 mg BID PO (day 1-5), and hyperfractionated twice daily radiotherapy (150 cGy per fraction) day 1-5 of a 14 day cycle which is repeated to deliver the prescribed radiotherapy dose.

Protocol documents:
Clinical trial NCT01145001
Conditions: Nicotine Dependence
Keywords: smoking adolescents contingency management nicotine replacement therapy
Sponsor: Yale University
Start date: 2009-11-01; Completion date: 2015-01-01
Enrollment: 154 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the the efficacy of adjunctive nicotine replacement therapy when used in combination with the contingency management (CM) + cognitive behavioral therapy intervention. Subjects will be randomly assigned to receive either a nicotine transdermal patch or a placebo patch as well as being randomly assigned to receive either CM or no CM; all subjects will receive cognitive behavioral therapy. We hypothesize that that subjects receiving both active nicotine patch and CM will have higher rates of abstinence from tobacco than subjects in the other groups.

Detailed description:

Arms: arm 1: Subjects in this group will receive Contingency Management and active nicotine patch arm 2: Subjects in this group will receive active nicotine patch without contingency management for abstinence arm 3: Subjects in this group will receive a placebo transdermal patch and contingency management arm 4: Subjects in this group will receive a placebo patch and will not receive contingency management
Interventions: intervention 1: Cognitive Behavioural Therapy intervention 2: Contingency Management intervention 3: Nicotine Transdermal Patch
Intervention descriptions: intervention 1: Weekly CBT for all subjects intervention 2: incentives given for abstinence based on urine analysis intervention 3: 14mg ir 21mg doses based on weight and #cigs/day

Protocol documents:
Clinical trial NCT01166139
Conditions: Systemic Sclerosis
Keywords: Systemic Sclerosis
Sponsor: Hospital for Special Surgery, New York
Start date: 2010-07-01; Completion date: 2015-01-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A phase IIa open-label single center pilot study to assess the safety and efficacy of Nilotinib in patients with Scleroderma.

Detailed description:
The purpose of this study is to learn how safe and tolerable a medication called Nilotinib (Tasigna) will be for patients diagnosed with Systemic Sclerosis. Systemic Sclerosis (scleroderma) is an autoimmune disease that can involve the skin, the blood vessels, the muscles and other connective tissues, and major organs including the lungs, kidneys, gastrointestinal tract, and heart. The exact cause of this disorder is not known at this time and no drug has been proven to cure scleroderma. Experiments done in animal models and "test-tube" models of fibrosis suggest that Nilotinib may be a useful therapy for scleroderma. Nilotinib is a medication on the market which has been FDA approved for the treatment of a type of leukemia called chronic myelogenous leukemia (CML). It is an oral medication, taken two times a day.

This is a 32 week, open-label, Phase IIa, single center clinical trial. The primary goal of the study is to assess the safety and tolerability of Nilotinib in patients with scleroderma. The secondary goal is to assess how effective Nilotinib is in treating patients with scleroderma. The clinical tests performed such as the Modified Rodnan Skin Score, Pulmonary Function Tests, Echocardiograms, Electrocardiograms, and the blood and skin collected in this study will help determine whether this therapy is safe and effective, and also improve our understanding of scleroderma.

Arms: arm 1: None
Interventions: intervention 1: Nilotinib (Tasigna)
Intervention descriptions: intervention 1: Patients will be treated with Nilotinib 400 mg two times a day for 6 months.

Protocol documents:
Clinical trial NCT01183104
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes Sitagliptin Glimepiride Elderly patients Japanese
Sponsor: Japan Association for Diabetes Education and Care
Start date: 2010-08-01; Completion date: 2015-01-01
Enrollment: 305 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy and the safety of sitagliptin and glimepiride in drug naïve elderly patients with Type 2 diabetes as evaluated by HbA1c change from baseline at 52 W as efficacy and incidence of hypoglycemia from randomization to 52 W as safety. The clinical hypotheses are non-inferiority of sitagliptin to glimepiride in efficacy as judged by HbA1c change from baseline at 52 W and superiority of sitagliptin to glimepiride in safety as judged by incidence of hypoglycemia in drug naïve elderly patients with T2DM. In addition, comparison of efficacy is extended to 104 W.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Sitagliptin intervention 2: Glimepiride
Intervention descriptions: intervention 1: Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; estimate glomerular filtration rate (eGFR) 30=\< \<50). intervention 2: Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg

Protocol documents:
Clinical trial NCT01215032
Conditions: Prostate Cancer
Keywords: castration-resistant prostate cancer insulin levels metformin
Sponsor: Massachusetts General Hospital
Start date: 2010-09-01; Completion date: 2015-01-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Metformin is a medication that is prescribed for people with diabetes to help the body respond better to its own insulin and decrease sugar production by the liver. This helps control the body's blood sugar level and is approved by the Food and Drug Administration (FDA) for the treatment of diabetes. Participant's in this research study will already be receiving androgen deprivation therapy (ADT) for prostate cancer. ADT is considered standard of care for prostate cancer. Changes in the participant's metabolism, including changes in insulin and blood sugar levels, are often seen as a result of this type of hormone therapy. Some studies have shown a relationship between insulin and prostate cancer. These studies have suggested that insulin may signal tumor cells to grow. Other studies suggest that people receiving metformin treatment for diabetes may enjoy better outcomes from their prostate cancer then other similar patients who are not treated with metformin.

Detailed description:
* Each treatment cycle lasts 4 weeks (28 days). Participants will take metformin twice a day for all 28 days (except for the first 7 days of the first cycle when they will take it just once daily.)
* The following procedures will be done on Day 1 of treatment cycles 1, 2, 4, 7 and 10: medical history review, performance status, physical exam, blood tests.
* If the participant's first computed tomography (CT) or bone scan at the time of screening showed evidence of cancer, CT and bone scans will be repeated on Day 1 of treatment cycles 4, 7 and 10.
* Participants will be in this research study for about 12 months.

Arms: arm 1: This is the only arm of this phase 2 open label study
Interventions: intervention 1: Metformin
Intervention descriptions: intervention 1: Taken orally twice daily each 28-day cycle, for 12 cycles

Protocol documents:
Clinical trial NCT01225263
Conditions: Migraine
Keywords: Migraine disorders Headache Simvastatin Vitamin D
Sponsor: Rami Burstein
Start date: 2010-09-01; Completion date: 2015-01-01
Enrollment: 89 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators are studying if taking simvastatin and vitamin D together will help prevent episodic migraines. Simvastatin is an FDA approved drug that is typically used to treat high cholesterol and reduce the risk of stroke and heart attack. Vitamin D is a vitamin found in certain foods like some types of fish, and in nutritional supplements. This study is 9 months long. Some people who participate will receive simvastatin and vitamin D, and some people will receive a placebo. A placebo is a "sugar pill" that looks like medication but does not have any active ingredients in it.

The investigators hypothesize that taking vitamin D and simvastatin daily may reduce the number of migraines people who have episodic migraine get.

Detailed description:

Arms: arm 1: Participants in this arm will receive simvastatin + vitamin D. arm 2: Participants in this arm will take placebo pills, which look like the simvastatin and vitamin D. A placebo pill has no active medication in it, and is like taking a "sugar pill".
Interventions: intervention 1: Simvastatin intervention 2: Vitamin D intervention 3: Placebo
Intervention descriptions: intervention 1: simvastatin, 20 mg, twice daily for 6 months intervention 2: Vitamin D3, 1000 IU, twice daily for 6 months intervention 3: Two placebo pills, taken twice daily for 6 months

Protocol documents:
Clinical trial NCT01226745
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis ONO-4641 MSC2430913A Efficacy
Sponsor: EMD Serono
Start date: 2010-10-01; Completion date: 2015-01-01
Enrollment: 340 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this active-drug Extension Study is to evaluate the continuing safety and efficacy of ONO-4641 (MSC2430913A) in subjects with relapsing-remitting multiple sclerosis (RRMS) who have completed an initial 26-week Core Study (ONO-4641POU006 \[NCT01081782\]).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: ONO-4641 intervention 2: ONO-4641 intervention 3: ONO-4641 intervention 4: ONO-4641 intervention 5: ONO-4641 intervention 6: ONO-4641
Intervention descriptions: intervention 1: Subjects will be administered with ONO-4641 at a dose of 0.15 milligram (mg) in the core study will be administered with ONO-4641 0.15 mg in this extension study for a duration of 225 weeks. intervention 2: Subjects will be administered with ONO-4641 at a dose of 0.10 mg in the core study will be administered with ONO-4641 0.10 mg in this extension study for a duration of 225 weeks. intervention 3: Subjects will be administered with ONO-4641 at a dose of 0.05 mg in the core study will be administered with ONO-4641 0.05 mg in this extension study for a duration of 225 weeks. intervention 4: Subjects will receive placebo in the core study will be administered with ONO-4641 0.15 mg in this extension study for a duration of 225 weeks. intervention 5: Subjects will receive placebo in the core study will be administered with ONO-4641 0.10 mg in this extension study for a duration of 225 weeks. intervention 6: Subjects will receive placebo in the core study will be administered with ONO-4641 0.05 mg in this extension study for a duration of 225 weeks.

Protocol documents:
Clinical trial NCT01230424
Conditions: Osteoarthritis (OA) of the Knee
Keywords: OA Knee arthritis MRI Steroid
Sponsor: Tufts Medical Center
Start date: 2011-03-01; Completion date: 2015-01-01
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A steroid (triamcinolone) 40 mg will be compared to placebo in a randomized placebo-controlled clinical trial testing the effect of this steroid versus placebo given into the study knee joint that has osteoarthritis (OA). The knee injection will be given once every 12 weeks over two years for a total of eight knee injections. How well each participant tolerates each injection and all the injections over time will be assessed. The safety of getting a knee injection every 12 weeks will be assessed by collecting reported adverse effects, knee examinations, and clinical laboratory tests. Participants will complete questionnaires, X-ray, MRIs, and bone density tests as part of this study.

Detailed description:
This study was a two-year stratified and block-randomized double-blind, placebo controlled clinical trial of the effect of intra-articular triamcinolone 40 mg injectable suspension, administered every 3 months over two years (for a total of 8 doses). The randomization was stratified by the baseline radiographic severity of knee OA (Kellgren and Lawrence grade of 2 or 3) and gender. An interim analysis would have been conducted after the first half of participants has completed the trial. This interim analysis would have allowed the trial to be stopped early for either success or futility, or allow the trial to continue if neither success nor futility has been established. However, the plan for interim analysis was eliminated with the support of the DSMB because of feasibility issues for completing cartilage measurements contemporaneously and because early trial cessation would preclude analysis of informative secondary outcomes. The primary structural outcome objective in this study was cartilage volume loss; secondary structural outcomes included peri-articular bone marrow lesions (BML), tibial peri-articular bone density ratio (paBMD). The primary clinical outcome objective was the pain domain of the WOMAC© LK3.1; secondary clinical outcomes included WOMAC© LK3.1 stiffness and function scores and physical function tests.

Arms: arm 1: 40 mg into the study knee joint every 12 weeks for a total of 8 injections. arm 2: 0.9% Sodium chloride injection as Placebo will be given into the study knee once every 12 weeks for a total of 8 injections.
Interventions: intervention 1: Triamcinolone Acetonide intervention 2: 0.9% Sodium Chloride Injection as Placebo
Intervention descriptions: intervention 1: 40 mg into the study knee joint every 12 weeks for a total of 8 injections. intervention 2: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.

Protocol documents: