ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01163604
Conditions: CVD
Keywords: Argatroban intracranial artery stenting extracranial artery stenting occlusion restenosis
Sponsor: Jinling Hospital, China
Start date: 2010-08-01; Completion date: 2014-08-01
Enrollment: 114 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Argatroban is a selective thrombin inhibitor, and previous study had suggested that argatroban use post PCI could potentially prevent reocclusion. But there has no study on large sample of argatroban treated restenosis post cranial stenting. This study will test the safety and efficacy of the argatroban on prevent occlusion and restenosis in patients with intracranial and extracranial artery stenting.

Detailed description:
The risk of restenosis post intracranial and extracranial artery stenting is 20-40%, therefore, in the past, aspirin and clopidogrel were performed as anticoagulant therapy post stenting.But this treatment had limited effectiveness upon restenosis. Argatroban is a selective thrombin inhibitor, and previous study had suggested that argatroban use post PCI could potentially prevent reocclusion. But there has no study on large sample of argatroban treated restenosis post cranial stenting. This study will test the safety and efficacy of the argatroban on prevent occlusion and restenosis in patients with intracranial and extracranial artery stenting.

Arms: arm 1: Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive continuous infusions of argatroban for 2 days before and 3 days after stenting, with accompanied aspirin and clopidogrel treatment. arm 2: Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.
Interventions: intervention 1: Argatroban intervention 2: non-argatroban treated group
Intervention descriptions: intervention 1: Intravenous Infusion, 20mg/day for 2 days before and 3 days after stenting, (10mg/3h, twice a day), with accompanied aspirin and clopidogrel treatment intervention 2: Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.

Protocol documents:
Clinical trial NCT01194479
Conditions: Type 1 Diabetes
Keywords: type 1 diabetes hypoglycemia formoterol
Sponsor: Yale University
Start date: 2010-08-01; Completion date: 2014-08-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Insulin treatment often causes the blood glucose levels to fall too low. The body usually responds to low blood glucose levels by releasing hormones which act against the insulin to help correct the low blood glucose levels. However, this hormone response can be altered in people with diabetes. Currently there are no therapeutic agents that can be used to improve the recovery from hypoglycemia (low blood sugar). The aim of this study is to determine whether a formoterol inhaler can be used to improve and accelerate the recovery from hypoglycemia in patients with type 1 diabetes.

Detailed description:
Note: Below is the original detailed description submitted in 2010. The recruitment for this study was stopped at 7 subjects in each study arm. The study design and outcome measures did not change for this study. See below for further details.

Original: 15 subjects with well controlled type 1 diabetes and regular hypoglycemia and 15 healthy volunteers will be recruited for this study.

If you agree to participate in this study, you will be asked to participate in a screening at Yale New Haven Hospital. Each study subject will undergo two hypoglycemic clamp studies (a procedure where the blood sugar is closely regulated with intravenous insulin and glucose.) In these hypoglycemic clamp studies, the subject will be given an inhaler. On one visit the inhaler will contain formoterol capsules and on the other visit, the subject will be given 'dummy' capsules. Subjects will be required to be admitted to the HRU the night before the study so that glucose levels can be stabilized and hypoglycemia avoided.

Arms: arm 1: The active group were participants with type 1 diabetes. arm 2: The control group were participants without diabetes, matched by sex, age and BMI to the active comparator group.
Interventions: intervention 1: Formoterol intervention 2: Placebo
Intervention descriptions: intervention 1: Formoterol inhaler, 12mcg capsules, 4 capsules for one administration intervention 2: Participants in both arms received placebo on 1 of the 2 visits.

Protocol documents:
Clinical trial NCT01231373
Conditions: Varicose Veins
Keywords: varicose veins
Sponsor: Boston Scientific Corporation
Start date: 2010-11-01; Completion date: 2014-08-01
Enrollment: 235 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and may cause discomfort. In this study, patients with varicose veins in the legs will be participating. The purpose of this research study is to evaluate the safety and effectiveness of three different concentrations of an investigational drug, Polidocanol Endovenous Microfoam (PEM) compared to vehicle (inactive solution) in treating the symptoms and appearance of varicose veins.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: polidocanol injectable foam, 0.125% intervention 2: polidocanol injectable foam, 0.5% intervention 3: polidocanol injectable foam, 1.0% intervention 4: Vehicle
Intervention descriptions: intervention 1: active placebo for blinding intervention 2: 0.5% polidocanol foam injection intervention 3: 1.0% polidocanol foam injection intervention 4: injection of vehicle comparator

Protocol documents:
Clinical trial NCT01245439
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2011-09-01; Completion date: 2014-08-01
Enrollment: 65 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label study will evaluate the safety, tolerability and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis (RA) on background non-biologic DMARDs who have an inadequate response to current non-biologic DMARDs. Patients will receive 8 mg/kg RoActemra/Actemra as an intravenous infusion every 24 weeks for a total of 6 infusions. The anticipated time on study treatment is 24 weeks.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: tocilizumab [RoActemra/Actemra]
Intervention descriptions: intervention 1: 8 mg/kg intravenous infusion every 4 weeks for a total of 6 infusions

Protocol documents:
Clinical trial NCT01268644
Conditions: Type 1 Diabetes
Keywords: Type 1 Diabetes Mellitus
Sponsor: University of Texas Southwestern Medical Center
Start date: 2010-09-01; Completion date: 2014-08-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will add leptin therapy to the current insulin therapy of Type 1 Diabetics with the aim of lowering the total insulin requirements and suppressing the steep fluctuations typically associated with Type 1 Diabetes.

Detailed description:
The adipocyte hormone, leptin, has been shown to restore the health and glucoregulation of near-death, insulin deficient diabetic rodents. This makes leptin the only hormone, since the discovery of insulin in 1922, with this capability. Leptin normalizes the hyperglucagonemia of diabetes and reduces lipogenesis and cholesterologenenesis. Treatment of diabetic rodents with a combination of leptin and insulin, leads to a stable pattern of glucose control with reduced insulin requirements, as opposed to the high glucose variability that characterizes the treatment of type 1 diabetes with supraphysiologic doses of insulin alone. As such, we will initiate a pilot clinical trial to test combination leptin and insulin therapy in type 1 diabetes. Fifteen leptin sensitive patients (body mass index \<27 kg/m²) with uncontrolled diabetes (HbA1c 7.0 to 10.0 %) will be treated with slightly supraphysiologic doses of recombinant human leptin (Amylin Pharmaceuticals). Subjects will be compared to themselves before and after treatment with leptin. Endpoint variables include HbA1c, change in daily insulin dose, mean and standard deviation of blood glucose from inpatient glucose monitoring and glucose meter download. We will also assess effects of leptin therapy on energy intake as assessed by 3-day food record and body weight and fat by DEXA. Intramyocellular and intrahepatic lipid concentration by 1H-MRS will be assessed before and after 3 months of metreleptin therapy. A satiety analysis will be employed. In addition, plasma hormones and inflammatory biomarkers will be assayed during the course of this study.

Arms: arm 1: Active open label Leptin for type 1 Diabetes
Interventions: intervention 1: Leptin
Intervention descriptions: intervention 1: weight based sub-cutaneous injection twice daily of Leptin

Protocol documents:
Clinical trial NCT01277757
Conditions: Recurrent Breast Carcinoma Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2011-03-01; Completion date: 2014-08-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well Akt inhibitor MK2206 works in treating patients with breast cancer cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine whether v-akt murine thymoma viral oncogene (Akt) inhibitor MK2206 achieves objective tumor responses (complete response \[CR\], partial response \[PR\]) in advanced breast cancer patients who have a phosphoinositide-3-kinase, catalytic, alpha polypeptide (PIK3CA) or Akt mutation and/or phosphatase and tensin homolog (PTEN) loss or mutation.

SECONDARY OBJECTIVES:

I. To determine the 6 month progression-free survival on MK2206. II. To determine baseline molecular markers that may predict clinical outcome. III. To determine pharmacodynamic markers in blood and tumor tissue that may predict a decrease in proliferation-related Ki-67 antigen (Ki-67) and clinical outcome.

IV. To determine safety and tolerability of MK2206 in previously treated patients with advanced breast cancer.

V. To determine if decrease in Ki-67 at 2 weeks correlates with anti-tumor effect (CR, PR, or stable disease \[SD\] \> 6 months).

VI. To determine concordance of PIK3CA and PTEN status between primary tumor and distant metastasis.

VII. To determine concordance of PIK3CA status of circulating free deoxyribonucleic acid (DNA) and distant metastasis.

OUTLINE:

Patients receive Akt Inhibitor MK-2206 orally (PO) on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 3 weeks.

Arms: arm 1: Akt Inhibitor MK-2206 mg orally once a week on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Akt Inhibitor MK2206 intervention 2: Laboratory Biomarker Analysis intervention 3: Pharmacological Study
Intervention descriptions: intervention 1: Given orally (PO) weekly, starting (dose 0) at 200 mg intervention 2: Correlative studies intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT01280409
Conditions: Diabetes, Gestational
Sponsor: The University of Texas Health Science Center, Houston
Start date: 2011-01-01; Completion date: 2014-08-01
Enrollment: 114 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the study drug metformin is helpful in reducing weight after pregnancy in women with gestational diabetes. This pilot study will provide information on how well women are able to take metformin postpartum, whether metformin increases weight loss, and whether there are any increased risks of side effects to you as a new mother.

Detailed description:
At 24-48 hours after delivery, women who are eligible for participation will be approached and consented to the study. Maternal weight will be measured and 20ml of maternal blood will be obtained to assess glucose control and lipid profile. Women will be counseled regarding diet, exercise and glucose control. Data including maternal demographics, clinical characteristics and neonatal outcomes will be collected. At 3 weeks postpartum, a research nurse will contact the subject via telephone call to inquire about adverse or side effects, ability to take the prescribed medication (metformin or placebo), and to answer questions about the study. At 6 weeks postpartum, maternal weight will be measured , blood will be obtained and side effects will be evaluated again. Finally, a satisfaction survey will be completed.

Arms: arm 1: Compounded placebo arm 2: Compounded metformin as the intervention
Interventions: intervention 1: Metformin intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks intervention 2: Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks.

Protocol documents:
Clinical trial NCT01280721
Conditions: Autosomal Dominant Polycystic Kidney Disease （ADPKD)
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2010-11-01; Completion date: 2014-08-01
Enrollment: 135 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
ADPKD patients who enrolled in Trial 156-04-251 will receive repeated oral administration of tolvaptan twice daily (morning and evening: 45mg/15mg, 60mg/30mg, or 90mg/30mg).

Detailed description:

Arms: arm 1: Repeated oral administration twice daily (morning and evening) at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg.
Interventions: intervention 1: tolvaptan
Intervention descriptions: intervention 1: Repeated oral administration twice daily (morning and evening) at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg.

Protocol documents:
Clinical trial NCT01282476
Conditions: Diffuse Large B Cell Lymphoma
Keywords: DLBCL (Diffuse Large B Cell Lymphoma) Panobinostat LBH589 (Panobinostat) LBH-589 (Panobinostat) HDAC inhibitor (Histone deacetylase inhibitor) DAC inhibitor (deacetylase inhibitor) deacetylase inhibitor lymphoma
Sponsor: Massachusetts General Hospital
Start date: 2011-06-01; Completion date: 2014-08-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Panobinostat is a drug that may slow down the growth of cancer cells or kill cancer cells by blocking certain enzymes. Panobinostat has shown effects against cancer in laboratory studies. However, it is not known if it will show the same activity in humans. Panobinostat has been given to participants with various types of cancers, including DLBCL, in previous research studies. In this study panobinostat will be given with the the antibody rituximab, which is FDA approved to be given with chemotherapy in DLBCL.

Detailed description:
Study treatment will be given in 4 week periods called cycles. Panobinostat will be taken orally on Monday, Wednesday, and Friday of each week. Rituximab will be given as an intravenous infusion weekly during Cycle 1 and then once per month on day 1 of subsequent cycles. Subjects can receive up to 6 cycles of treatment. Blood draws and 2 EKGs (electrocardiograms) will be done weekly in Cycle 1 and then once in each cycle. PET/CT (Positron Emission Tomography/Computed Tomography) scans will be done every 2 months.

If disease has not progressed after 6 cycles on combination of panobinostat and rituximab, subjects may continue on panobinostat alone for up to 6 additional months.

Arms: arm 1: single-arm, open-label; Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m\^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.
Interventions: intervention 1: Panobinostat with Rituximab
Intervention descriptions: intervention 1: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m\^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.

Protocol documents:
Clinical trial NCT01289639
Conditions: Fatty Liver
Keywords: non-alcoholic fatty liver disease non-alcoholic steatohepatitis insulin resistance pioglitazone fenofibrate
Sponsor: VA Office of Research and Development
Start date: 2005-10-01; Completion date: 2014-08-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is designed to investigate the relationship between insulin resistance and non-alcoholic fatty liver disease (NAFLD) and to investigate potential mechanisms underlying insulin resistance in NAFLD by determining associations between hepatic and peripheral insulin sensitivity, hepatic steatosis, dyslipidemia, inflammatory cytokines, glucose metabolism, beta-cell function and body fat distribution.

Detailed description:
NAFLD and nonalcoholic steatohepatitis (NASH) are common liver disorders that are strongly associated with obesity, type 2 diabetes and dyslipidemia. The underlying pathophysiology of fatty infiltration of the liver is thought to be related to insulin resistance, which is an almost universal finding in patients with NAFLD. It is also possible that fat infiltration and inflammation in the liver may impair insulin sensitivity, either locally in the liver, or peripherally via the actions of inflammatory cytokines. We hypothesize that insulin resistance is a major causal factor leading to fat deposition in the liver and NAFLD, and thus interventions aimed at improving insulin sensitivity will result in a reduction of hepatic inflammation and steatosis.

Specific Aim 1: To determine in a cross-sectional study whether NAFLD is associated with altered peripheral and hepatic insulin sensitivity and to study their relationships with hepatic steatosis, dyslipidemia, inflammatory cytokines, glucose metabolism, beta-cell function and body fat distribution. Specific Aim 2: To determine in a 6 month placebo-controlled double-blinded treatment study if treatment with pioglitazone, an insulin sensitizer, or fenofibrate, a triglyceride lowering agent, will improve both hepatic as well as peripheral insulin sensitivity and thereby improve hepatic steatosis and inflammation in subjects with NAFLD.

The results of the proposed study will have important implications for our understanding of the mechanisms underlying insulin resistance and abnormalities in lipid and glucose metabolism in subjects with NAFLD and for the design of future studies aimed at the prevention and treatment of this condition.

Arms: arm 1: matching placebo 1 po qd arm 2: micronized fenofibrate 200 mg 1 po qd arm 3: pioglitazone 30 mg po qd
Interventions: intervention 1: fenofibrate intervention 2: pioglitazone intervention 3: placebo
Intervention descriptions: intervention 1: micronized fenofibrate 200 mg 1 po qd intervention 2: pioglitazone 30 mg po qd intervention 3: placebo 1 capsule po qd

Protocol documents:
Clinical trial NCT01314014
Conditions: Follicular Lymphoma Small Lymphocytic Lymphoma Marginal Zone Lymphoma Lymphoplasmacytic Lymphoma Diffuse Large B Cell Lymphoma Mantle Cell Lymphoma Burkitt's Lymphoma
Keywords: Non Hodgkin's Lymphoma Lymphoma, Low Grade Lymphoma, Intermediate Grade Lymphoma, High Grade Lymphoma, B Cell
Sponsor: University of Rochester
Start date: 2011-05-01; Completion date: 2014-08-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether Amplimexon (imexon for injection) is effective in the treatment of indolent and aggressive lymphomas that have progressed after treatment with standard therapies.

Detailed description:
A phase II exploratory trial of imexon in lymphoma is justified by: (1) the observation of clinical activity (partial response to the drug observed in phase I testing in a subject with refractory indolent lymphoma); (2) the finding that imexon prevents the development of human immunoblastic lymphoma in SCID mice; (3) the finding that lymphoma cell lines are killed by readily achievable doses; and (4) translational studies implicating the importance of the redox state of the cancer cell.

The dose and schedule chosen (1000 mg/m2 daily X 5 days every 3 weeks) is based on tolerability and subject acceptance in prior AmpliMed phase I studies.

The planned correlative studies should help to identify potential biomarkers for response to imexon and provide further insight into potential mechanisms of imexon action hypothesized from results of prior laboratory studies.

Arms: arm 1: Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes.
Interventions: intervention 1: Imexon
Intervention descriptions: intervention 1: Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment.

Protocol documents:
Clinical trial NCT01354132
Conditions: Schizophrenic Psychoses
Keywords: schizophrenia schizoaffective schizophreniform early schizophrenia spectrum psychosis
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2011-05-01; Completion date: 2014-08-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators seek to examine the effect of add-on N-Acetyl-Cysteine (NAC) in the early phase of schizophrenia spectrum illness in collaboration with researchers Kim Do, PhD, and Philippe Conus, MD in Switzerland. Modifications of brain structure are thought to occur during the pre-illness phase and around the transition to psychosis. Therefore, studying new treatments that could target changes occurring during this period is of critical importance.

Aims:

Does add-on NAC treatment in early psychosis influence:

* positive and negative symptoms
* extrapyramidal side-effects of other medication
* plasma concentration of glutathione
* Mismatch Negativity, a physiological marker

Detailed description:
The study proposes that a glutathione deficit leading to an abnormal response to oxidative stress is a vulnerability factor, combined with other brain specific factors, in brain functioning of some individuals with schizophrenia (Do et al., 2010). N-acetyl-cysteine is hypothesized to cross the blood-brain barrier and increase glutathione in the brain.

Arms: arm 1: N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks arm 2: matching effervescent tablets in water 2 in am and 1 in pm
Interventions: intervention 1: n-acetylcysteine intervention 2: Placebo
Intervention descriptions: intervention 1: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM intervention 2: Placebo tablets are placed in water or juice in the AM and PM

Protocol documents: