ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01532570
Conditions: Behcet's Disease Behcet Syndrome Neuro-Behcet's Disease
Keywords: Behcet's disease intestinal Behcet's disease neuro-Behcet's disease vascular Behcet's disease
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2012-01-01; Completion date: 2014-05-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of TA-650 in patients with Behcet's disease ( BD ) with special lesions after the administration of TA-650 at a dosage of 5 mg/kg in weeks 0, 2, and 6, then every 8 weeks after week 14 up to week 46.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: TA-650
Intervention descriptions: intervention 1: TA-650 will be intravenously infused at a dosage of 5 mg/kg slowly over a period of more than 2 hours at the first administration (weeks 0), 2, and 6, and then every 8 weeks up to week 46. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.

Protocol documents:
Clinical trial NCT01533753
Conditions: Prostate Cancer
Keywords: hot flashes prostate cancer
Sponsor: University of Wisconsin, Madison
Start date: 2012-02-01; Completion date: 2014-05-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the change in quality of life over a 6 month period between gabapentin and venlafaxine in men with prostate cancer treated for hot flashes related to androgen deprivation therapy.

Detailed description:
60 evaluable patients with prostate cancer currently receiving androgen ablation therapy or who have had an orchiectomy will be enrolled in this study. All patients will be randomized 1:1 (30 patients per treatment arm) to either receive gabapentin or venlafaxine. Treatment duration will be a total of 6 months. During those 6 months, study staff will evaluate frequency and intensity of hot flashes using hot flash score from hot flash diary every 28 days. Patients will also record side effects associated with either gabapentin or venlafaxine on their medication diaries. Study staff will record the severity of all adverse events reported. Patients will also complete the quality of life Functional Assessment of Cancer Therapy-Prostate (FACT-P) form at baseline, cycle 3, and cycle 6/off study.

Arms: arm 1: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days. arm 2: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.
Interventions: intervention 1: Gabapentin intervention 2: Venlafaxine
Intervention descriptions: intervention 1: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days. intervention 2: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.

Protocol documents:
Clinical trial NCT01562678
Conditions: Diabetes Effects of Liraglutide Administration on Brain Activity Weight Loss Hunger
Keywords: fMRI Liraglutide diabetes GLP-1
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2012-03-01; Completion date: 2014-05-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The main purpose of this study is to help us understand the effects of diabetes medication Liraglutide on weight loss and hunger. The investigators have already determined what the highest tolerated dose of Liraglutide is through earlier human research studies. Liraglutide was approved by the FDA in January 2010 for treatment of diabetes.

The investigators will also study the following:

1. The impact of Liraglutide on brain responses to food
2. It's effect on physiological and mental performance
3. If its effect on the brain differs among obese and lean diabetic subjects.

Detailed description:
This is a randomized, placebo controlled, cross-over, double-blinded study to assess the effects of liraglutide on brain activation in areas involved in cognitive control and reward during food visualization.

Study participation will span approximately 1.5-2 months. Subjects will learn to self-administer the medication and will have a total of 8 study visits plus one screening visit. The visits will include the following tests/procedures:

1. Vital signs (blood pressure, temperature, heart rate, breathing rate)
2. Height, weight and other body measurements like waist
3. Blood tests
4. Urine pregnancy test (women only)
5. Electrocardiogram (EKG)
6. Medical history
7. Physical exam
8. Body Composition tests
9. Study logs to record food intake and blood sugar
10. functional MRI

We plan to recruit a total of 24 subjects to be treated with placebo and liraglutide. We propose to enroll 12 obese diabetic (type 2) and 12 lean diabetic (type 2) subjects. Equal numbers of men and women will be enrolled and the randomization will block for gender.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Liraglutide intervention 2: Placebo
Intervention descriptions: intervention 1: In the experimental arm of this randomized, placebo controlled, cross-over, double-blinded study to assess the effects of liraglutide. Subjects will self-inject Liraglutide once per day for 18 days. Subjects will start the treatment with a dose of 0.6 mg for the first week, then 1.2 mg for the second week and 1.8 mg for 3 days in the third week. intervention 2: In the placebo arm of this randomized, placebo controlled, cross-over, double-blinded study to assess the effects of liraglutide. Subjects will self-inject placebo once per day for 18 days.

Protocol documents:
Clinical trial NCT01576042
Conditions: Ventricular Tachycardia
Keywords: Ischemic heart disease Implantable Cardioverter Defibrillator Ventricular Tachycardia Patient with Implantable Cardioverter Defibrillator (ICD)
Sponsor: Duke University
Start date: 2012-05-01; Completion date: 2014-05-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this pilot trial is to determine the feasibility of a large, multi-center randomized clinical trial aimed to test whether a treatment strategy of percutaneous catheter ablation of ventricular tachycardia (VT) is superior to state-of-the-art pharmacologic therapy at reducing all-cause mortality in patients with an implantable cardioverter defibrillator (ICD) who receive therapy for VT in the absence of any reversible cause.

Detailed description:
This study will be conducted at up to 8 sites and will randomize 50 patients over 1 year to a strategy of catheter ablation (n=25) vs. state-of-the-art pharmacologic therapy (n=25). To be considered for enrollment in this pilot trial, patients must be at least 18 years of age and must have an ICD for a primary or secondary prevention indication, have ≥ 1 documented ICD shock or ≥ 3 ATP therapies for VT in the absence of a reversible cause that in the opinion of the treating physician requires further therapy and be eligible for both catheter ablation and at least 1 antiarrhythmic medication. Patients will be followed at 3 and 6 months and their vital status will be determined via a phone call at 12 months. Data on the safety and efficacy of therapies used in the pilot study will be collected. Of particular interest are adverse events resulting from the catheter ablation procedure and major side effects from antiarrhythmic medications.

Arms: arm 1: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults arm 2: The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death
Interventions: intervention 1: amiodarone intervention 2: sotalol intervention 3: Biosense Webster's NAVI-STAR Thermo-Cool
Intervention descriptions: intervention 1: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death. intervention 2: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death. intervention 3: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults.

Protocol documents:
Clinical trial NCT01576146
Conditions: Secondary Hyperparathyroidism
Keywords: Clinical Trial, Phase 2 Renal Dialysis Secondary Hyperparathyroidism Chronic kidney disease-mineral and bone disorder Parathyroid hormone
Sponsor: KAI Pharmaceuticals
Start date: 2012-03-01; Completion date: 2014-05-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the long term safety and efficacy of thrice weekly intravenous (IV) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in patients receiving hemodialysis who had completed 12 weeks of treatment with etelcalcetide in parent study 20120331 (KAI-4169-005; NCT01414114).

Detailed description:

Arms: arm 1: Participants received a bolus IV injection of etelcalcetide 3 times a week (TIW) at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.
Interventions: intervention 1: Etelcalcetide
Intervention descriptions: intervention 1: Administered as an intravenous bolus three times a week at the end of each hemodialysis session at dosages up to a maximum of 15 mg.

Protocol documents:
Clinical trial NCT01584544
Conditions: Rectal Neoplasms
Keywords: rectal neoplasms aged chemoradiotherapy clinical trials, phase I capecitabine
Sponsor: Chinese Academy of Medical Sciences
Start date: 2011-01-01; Completion date: 2014-05-01
Enrollment: 24 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This phase I study is designed to determine the maximum tolerant dose of capecitabine when used in preoperative concurrent chemo-radiation for locally advanced rectal patients over 75 years old.

Detailed description:
It is proved that preoperative concurrent chemo-radiotherapy can improve both local control and overall survival in stage II/III rectal cancer patients. But elderly patients, especially patients over 75 years were hardly involved in related clinical trials considered of their fragility.

Several retrospective study showed that old rectal cancer patients would also benefit from concurrent chemo-radiation, with acceptable toxicity. Several new drug, such as capecitabine, also seem to be safety for elderly cancer patients. But few prospective study has been carried out.

The investigators designed this phase I study, to explore the maximum tolerant dose of capecitabine in preoperative concurrent chemoradiation for elderly stage II/III rectal cancer patients, as well as to evaluate safety.

Arms: arm 1: capecitabine 1000mg/m2/d d1-14, d22-25 combined with concurrent radiotherapy will be given to enrolled patients. arm 2: capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients. arm 3: capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients. arm 4: capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients. arm 5: capecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Interventions: intervention 1: capecitabine intervention 2: Capecitabine intervention 3: Capecitabine intervention 4: Capecitabine intervention 5: Capecitabine
Intervention descriptions: intervention 1: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation intervention 2: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation intervention 3: oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation intervention 4: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation intervention 5: oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation

Protocol documents:
Clinical trial NCT01598207
Conditions: Chest Pain
Sponsor: Yehudith Assouline-Dayan
Start date: 2011-02-01; Completion date: 2014-05-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Background: Noncardiac chest pain (NCCP) affects 200,000 new cases annually in USA. It is associated with poor quality of life and high health care expenditure of 8 Billion Dollars a year.

Gastroesophageal Reflux Disease(GERD), esophageal motility disorders, and psychological issues may cause NCCP.

The mechanism(s) for pain continue to be explored and include central and peripheral hypersensitivity, and mechanophysical abnormalities. Treatment of NCCP has focused on relieving visceral hypersensitivity through pain modulators, such as tricyclics, trazodone, or adenosine receptor antagonist, theophylline. Typically, only 40-50 % respond and clearly there is a large unmet therapeutic need.

Cannabis is felt to be beneficial for vomiting, diarrhea and intestinal pain. The main component of Cannabis acts through specific receptors, that are located primarily on central and peripheral neurons (including the enteric nervous system) and myenteric plexus where they modulate neurotransmitter release. Activation of these receptors reduces excitatory enteric transmission and may improve esophageal hyperreactivity and hypersensitivity, the hallmarks of NCCP.

STUDY PROTOCOL: The investigators will randomize 40 subjects with non-cardiac, non-reflux chest pain to receive dronabinol (5 mg Bid), or placebo for 4 weeks. Chest pain symptoms and esophageal sensorimotor properties will be assessed at baseline and at 4 weeks using symptom diary and impedance planimetry. The primary outcome measure will be the frequency of chest pain episodes. Secondary outcome measures include improvement in esophageal sensory thresholds, reduced reactive contractions, frequency, amplitude, area under the curve, and global improvement of symptoms.

HYPOTHESIS: Cannabinoids decrease esophageal hypersensitivity and ameliorate chest pain in NCCP patients, when compared to placebo.

AIM: To perform a randomized double blind study to investigate the effects of Dronabinol, a CB1 and CB2 agonist, in the treatment of patients with NCCP and examine its mechanism of action.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Marinol intervention 2: Placebo
Intervention descriptions: intervention 1: 5mg BID, orally for 1 month intervention 2: 5mg BID, orally for 1 month

Protocol documents:
Clinical trial NCT01603420
Conditions: Prostate Cancer
Keywords: prostate cancer radiation proton chemotherapy high risk
Sponsor: Proton Collaborative Group
Start date: 2012-07-01; Completion date: 2014-05-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effects on prostate cancer using radiation therapy with or without chemotherapy.

Detailed description:
The recommended treatment for a high risk prostate cancer consists of a combination of radiation therapy and androgen suppression for 2-3 years. Recent studies have shown a survival advantage for chemotherapy for prostate cancer. Chemotherapy has already been successfully integrated in the treatment of other cancer types and is our belief that chemotherapy will prove to be beneficial for patients with high risk prostate cancer. However, a clinical study is necessary to compare the results good or bad of chemotherapy with radiation therapy.

Arms: arm 1: Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression). arm 2: Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).
Interventions: intervention 1: Luteinizing hormone-releasing hormone (LHRH) intervention 2: Docetaxel intervention 3: Conformal Radiation Therapy (RT)
Intervention descriptions: intervention 1: Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin. intervention 2: Docetaxel 20mg/m2 IV every 7 days x 8 weeks. intervention 3: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).

Protocol documents:
Clinical trial NCT01607658
Conditions: Female Orgasmic Disorder
Keywords: Testosterone
Sponsor: Acerus Pharmaceuticals Corporation
Start date: 2012-05-01; Completion date: 2014-05-01
Enrollment: 253 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess and compare the effects of 3 dose strengths of TBS-2 intranasal testosterone gel to placebo on the occurrence of orgasm.

Detailed description:

Arms: arm 1: Placebo intranasal gel administered prn, 2-8 hours before a planned sexual event arm 2: Low dose TBS-2 (0.6 mg) testosterone intranasal gel administered prn arm 3: Medium dose TBS-2 (1.2 mg) testosterone intranasal gel administered prn arm 4: High dose TBS-2 (1.8 mg) testosterone intranasal gel administered prn
Interventions: intervention 1: Placebo intervention 2: Low dose TBS-2 intervention 3: Medium dose TBS-2 intervention 4: High dose TBS-2
Intervention descriptions: intervention 1: placebo intranasal gel administered prn, 2-8 hours before a planned sexual event intervention 2: Low dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event intervention 3: Medium dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event intervention 4: High dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event

Protocol documents:
Clinical trial NCT01608724
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Keywords: Type 2 DM
Sponsor: AstraZeneca
Start date: 2012-11-01; Completion date: 2014-05-01
Enrollment: 2165 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The efficacy and safety study of saxagliptin 5mg, once daily for 24 weeks in patients with type 2 diabetes mellitus.

Detailed description:
A multicenter, single arm, cohort study to evaluate the Efficacy and Safety of saxagliptin 5mg, once daily for 24 weeks, in patients with type 2 diabetes mellitus who are treatment naive or who have inadequate glycaemic control on metformin alone

Arms: arm 1: Saxagliptin, oral 5mg once a day(Q. D.)
Interventions: intervention 1: Saxagliptin
Intervention descriptions: intervention 1: oral, 5 mg once a day (Q.D.)

Protocol documents:
Clinical trial NCT01608906
Conditions: Venous Thrombosis
Keywords: venous thrombosis heparin pulmonary embolism ICU
Sponsor: University of Colorado, Denver
Start date: 2007-05-01; Completion date: 2014-05-01
Enrollment: 152 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study plans to learn more about what is the best treatment to prevent blood clots in patients in intensive care units (ICU's). The investigators know that patients who are in ICU's have a higher than normal risk of getting blood clots in the veins of their arms or legs. This can be very dangerous as the clot may move into the lungs. To prevent this, the standard treatment is to give low dose heparin subcutaneously 3 times a day (usually 5000 units at each dose). In this study the investigators are randomizing patients to receive either standard of care or low dose intravenous heparin in a continuous infusion.

Detailed description:
Macro- and micro-thrombosis both contribute significantly to morbidity and mortality in the surgical intensive care unit. Pulmonary embolism (PE) is a common and preventable cause of death in critically ill patients, with a mortality rate of up to 10%. Up to 95% of cases of PE originate from deep venous thrombosis (DVT). There are multiple pharmacologic and non-pharmacologic methods of DVT prophylaxis.The current standard of care in thromboprophylaxis in the surgical intensive care unit (SICU) at the University of Colorado Hospital is low-dose subcutaneous heparin (SCH). However, there is little evidence that this is the optimal prophylactic treatment. In fact, a database search of ICD-9 diagnoses made in 2005 suggests that the incidence of DVT in SICU patients, the majority who receive subcutaneous heparin, is approximately 7%. Surgical ICU patients are at high risk of developing DVT during their hospital stay and likely need more aggressive anticoagulation. Intravenous heparin, given at a low dose and titrated to a measurable endpoint PTT (partial thromboplastin time), may offer several benefits over the current standard of care, subcutaneous heparin. This method of treatment would offer more aggressive anticoagulation and allow dosage to be adjusted frequently based on each patient's changing coagulation status.

Arms: arm 1: titrated to a PTT of 40-45 arm 2: standard of care
Interventions: intervention 1: low dose intravenous heparin (LDIVH) intervention 2: Heparin
Intervention descriptions: intervention 1: The LDIVH (experimental) group will receive a continuous heparin drip titrated to a prothrombin time (PTT) of 40-45. LDIVH subjects will have PTT tested within 24 hours prior to initiation of LDIVH. In addition, these subjects would continue to have a PTT tested every 6 hours until the PTT value falls between 40-45. All LDIVH subjects will have PTT values measured at least daily. This will continue until ICU discharge or a maximum of 28 days. intervention 2: 5000 units given subcutaneously three times a day until ICU discharge or a maximum of 28 days

Protocol documents:
Clinical trial NCT01614886
Conditions: Alzheimer's Disease
Keywords: Rivastigmine, Alzheimer's disease, Transdermal patch
Sponsor: Novartis Pharmaceuticals
Start date: 2012-07-01; Completion date: 2014-05-01
Enrollment: 216 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the tolerability, safety and efficacy of 3-step titration versus 1-step titration of Rivastigmine patch in the Japanese population.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Active Comparator intervention 2: ENA713
Intervention descriptions: intervention 1: 1-step titration group begin treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day. intervention 2: -3-step titration group will begin treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.

Protocol documents: