ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00770484
Conditions: Orthostatic Intolerance Postural Tachycardia Syndrome
Keywords: Exercise Propanolol Beta blockers
Sponsor: Vanderbilt University
Start date: 2008-11-01; Completion date: 2015-05-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The main limitation patients with orthostatic intolerance (OI, or postural tachycardia syndrome, POTS) have to exercise is related to their increase in heart rate when standing. Main pharmacological treatment today is aimed at reducing heart rate with the use of betablockers (propanolol), this theoretically could also improve their exercise capacity; if their heart rate do not increase as much with the medication, they could exercise more. In addition, it has been suggested that in healthy volunteers subjected to head down tilt for 2 weeks (situation that produces a "simulated" transient POTS-like state) a single bout of intense exercise can improve orthostatic tolerance the day after exercising. The mechanisms involved in such response are not that clear but could be an increase in plasma volume already diminished in POTS patients. It seems likely that the same could be true for POTS patients.

The purpose of the present study are to pharmacologically improve the amount of exercise POTS patients can perform by reducing their baseline heart rate (specific aim 1) and to evaluate next day heart responses to an acute bout of intense exercise.

Therefore, the specific aims of this study are:

1. To test the hypothesis that lowering heart rate response with propanolol will result in an increase in exercise capacity.
2. To test the hypothesis that a single bout of exercise will result in an improvement in orthostatic tolerance the day after exercising.

Detailed description:
* Subjects will be studied twice, once after receiving placebo and in a second occasion after receiving propanolol.
* An exercise capacity test with estimation of maximal oxygen consumption (VO2 max) will be done within 1 hour of receiving a pill containing placebo and that will be in appearance identical to the one for propanolol. This test will be conducted on a stationary bicycle and the effort will be gradually increased while expired air is measured during exhaustive physical work. The test will last approximately 30 minutes and be conducted in Vanderbilt's Clinical Trial Center.
* The day before and the day after the exercise test subjects will be asked to collect urine for 12 hours each time and to keep a record of how much liquid they ingest.
* Posture study tests (measurements of heart rate and blood pressure taken while lying down and at intervals for up to 30 minutes while standing) will be done the day before and the day after the exercise test.

Arms: arm 1: Active treatment arm 2: Placebo Treatment
Interventions: intervention 1: Propranolol then Placebo intervention 2: Placebo then Propranolol
Intervention descriptions: intervention 1: Propanolol 20 mg, given orally within 1 hour prior to exercising intervention 2: Placebo, matching pill given orally within 1 hour prior to exercising

Protocol documents:
Clinical trial NCT00782275
Conditions: Renal Cell Carcinoma Kidney Cancer
Keywords: RCC avastin temsirolimus
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2009-04-01; Completion date: 2015-05-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a single-arm phase II trial evaluating the combination of avastin and temsirolimus in patients with metastatic renal cell cancer (RCC) including both histologically confirmed clear cell (cc) or non-clear cell (ncc) subtypes. Patients must have experienced disease progression or intolerable toxicity with a vascular endothelial growth factor (VEGF)-targeted tyrosine kinase inhibitor (TKI) (e.g. sorafenib, sunitinib, pazopanib). Only 2 prior VEGF therapies are allowed. The purpose of this research study is to evaluate efficacy of the combination against an historical control. Temsirolimus has been approved by the Food and Drug Administration (FDA) in the treatment of renal cell carcinoma. Avastin has been approved by the FDA for other types of cancers but not renal cell carcinoma.

Detailed description:
Avastin, a humanized IgG1 monoclonal antibody (MAb), inhibits vascular endothelial growth factor (VEGF). VEGF is one of the most potent and specific proangiogenic factors and has been identified as a crucial regulator of both normal and pathological angiogenesis. Temsirolimus specifically inhibits the mammalian target of rapamycin (mTOR), a highly conserved serine/threonine kinase which regulates cell growth and metabolism in response to environmental factors. The combination avastin and temsirolimus has already demonstrated efficacy in the phase I setting

STATISTICAL CONSIDERATIONS:

The primary endpoint is 4-month PFS. The null and alternative hypotheses are 50% vs. 70%. Assuming 2 ineligible patients, the target sample size is 41 patients (39 eligible patients). The probability of concluding that the treatment is effective was \>0.90 if the true rate is at least 70%. The probability of concluding that the treatment is effective was ≤ 0.10 if the true rate was 50% or less. If 24 or more patients are alive and progression-free at 4 months, then this regimen would be considered for further study.

Arms: arm 1: bevacizumab: given intravenously at a dose of 10mg/kg every 2 weeks (days 1 and 15)

temsirolimus: given intravenously at a dose of 25mg weekly on days 1, 8, 15, and 22

1 cycle=28-days

There were no dose reductions for bevacizumab allowed. If bevacizumab was held, the same dose would be used if treatment were resumed. If temsirolimus was held, the same or a reduced dose (15mg IV weekly) could be used upon resumption of therapy. Treatment was continued until the development of unacceptable toxicity or progression.
Interventions: intervention 1: bevacizumab intervention 2: temsirolimus
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00802529
Conditions: Meniere's Disease
Keywords: Meniere's disease transtympanic steroids Randomised controlled trial
Sponsor: Imperial College London
Start date: 2009-04-01; Completion date: 2015-05-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial aims to compare transtympanic steroids against the standard treatment (transtympanic gentamicin) in refractory unilateral Meniere's disease.

Detailed description:
Meniere's disease is characterised by episodic spontaneous vertigo attacks with hearing loss, ringing sounds and fullness in the ear. In one out of five patients, standard first line medical treatment is not effective in controlling vertigo attacks. For these incapacitated patients, gentamicin injections through the ear drum is a well established minimally invasive treatment. Major surgery of the balance organs or nerve, risking complete hearing loss, CSF leak, meningeal infections, are rarely performed nowadays. Gentamicn is very effective in controlling vertigo and acts by chemical ablation of end organs. As hearing and balance organs are entwined around each other, gentamicin treatment does not come without the risk of hearing loss. In fact, meta-analysis shows hearing deterioration in 13% to 35% percent of gentamicin treated patients. On the other hand, steroids are drug of choice for autoimmune inner ear disease and commonly used for sudden hearing loss. They are non toxic drugs without any known side effects during local treatment in ear. We will compare the two in this randomised, double blind trial.

Arms: arm 1: Steroid (Methylprednisolone) arm 2: Gentamicin
Interventions: intervention 1: Methylprednisolone intervention 2: Gentamicin
Intervention descriptions: intervention 1: 2 transtympanic injections at interval of two weeks. intervention 2: 2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.

Protocol documents:
Clinical trial NCT00848926
Conditions: Disease, Hodgkin
Keywords: Antigens, CD30 Antibody-Drug Conjugate Antibodies, Monoclonal Disease, Hodgkin Hematologic Diseases Lymphoma monomethylauristatin E Drug Therapy Immunotherapy
Sponsor: Seagen Inc.
Start date: 2009-02-01; Completion date: 2015-05-01
Enrollment: 102 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a single-arm, open-label, multicenter, pivotal clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory Hodgkin lymphoma.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: brentuximab vedotin
Intervention descriptions: intervention 1: 1.8 mg/kg every 3 weeks by intravenous infusion

Protocol documents:
Clinical trial NCT00870727
Conditions: Pervasive Developmental Disorder
Keywords: PDD NOS
Sponsor: Indiana University
Start date: 2009-02-01; Completion date: 2015-05-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to develop a better tolerated and more effective pharmacologic treatment with individuals with Pervasive Developmental Disorder. This is a double-blind, placebo-controlled study of aripiprazole in the management of the maladaptive behaviors of Pervasive Developmental Disorder. The investigators hypothesize that aripiprazole will be more effective than placebo for reducing aggression, tantrum and self-injurious behavior in children with Pervasive Developmental Disorder.

Detailed description:
Pervasive developmental disorders (PDDs) are characterized by severe impairments in social interaction and communication in addition to restricted patterns of interests and activities. Research suggests that a dysregulation of the dopamine and serotonin systems contributes to these interfering behaviors in individuals with PDD. After benefits of typical neuroleptics were reported in subjects with PDD, research shifted to the atypical antipsychotics which have been shown to be better tolerated and effective in this population. However, the atypical antipsychotics have also been associated with adverse effects. Thus there remains a need for a novel pharmacotherapy that would be safe and effective for children and adolescents with PDDs. The primary objectives of this study are to determine whether aripiprazole is effective and well tolerated for irritability in children and adolescents with PDD not otherwise specified (NOS) during an 8-week acute phase and whether the effectiveness and tolerability of aripiprazole is maintained during a 16-week continuation phase.

Arms: arm 1: Participants will receive Aripiprazole oral product with a minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment. arm 2: Participants will receive matching (identical in size and appearance to study drug) placebo oral capsules over 8-weeks of treatment.
Interventions: intervention 1: Aripiprazole oral product intervention 2: Placebo oral capsule
Intervention descriptions: intervention 1: Minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment. intervention 2: Placebo will be identical in size and appearance to study drug.

Protocol documents:
Clinical trial NCT00880334
Conditions: Transitional Cell Carcinoma Bladder Cancer
Keywords: TCC Zactima docetaxel ZD6474 taxotere
Sponsor: Dana-Farber Cancer Institute
Start date: 2006-09-01; Completion date: 2015-05-01
Enrollment: 149 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this research study the investigators are looking to see if the combination of docetaxel plus Vandetanib is effective in the treatment of metastatic transitional cell carcinoma (TCC). Docetaxel is a chemotherapy drug that kills cancer cells that are dividing. It is widely used in TCC. Vandetanib is a drug that is believed to stop new blood vessels from forming around cancer cells. The combination of docetaxel and Vandetanib has been studied in people with lung cancer and found to be helpful in killing cancer cells. Thus, this study is looking at people with TCC, to see if the combination of docetaxel plus Vandetanib is better or worse then docetaxel alone.

Detailed description:
* Because no one knows which of the study options is best, and all of the options are considered equally likely to work, participants will be randomized into one of two study groups: docetaxel plus Vandetanib or docetaxel plus placebo.
* Each treatment cycle lasts three weeks during which time the participant will be taking Vandetanib or placebo once a day, every day. On Day 1 of each cycle (a cycle is 21 days), participants will receive docetaxel as an infusion through a vein in the arm over one hour.
* On Day 1 of every cycle the following tests and procedures will be performed: physical exam and blood tests. On day 1 and on Day 8 of the first cycle only, participants will have an ECG. Every 6-9 weeks (every 2 to 3 cycles), the participants tumor will be assessed by x-ray, CT scan, bone scan, and/or MRI.

Arms: arm 1: vandetanib orally and Docetaxel intravenously arm 2: Placebo orally and docetaxel intravenously
Interventions: intervention 1: Docetaxel intervention 2: vandetanib intervention 3: Placebo
Intervention descriptions: intervention 1: Given intravenously on Day 1 of each 21-day cycle intervention 2: taken orally once a day, every day intervention 3: Taken orally once a day every day

Protocol documents:
Clinical trial NCT00883337
Conditions: Multiple Sclerosis
Keywords: Relapsing-remitting multiple sclerosis
Sponsor: Sanofi
Start date: 2009-04-01; Completion date: 2015-05-01
Enrollment: 324 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary objective was to assess the effectiveness evaluated by the time to failure of two doses of teriflunomide in comparison to interferon beta-1a in participants with relapsing Multiple Sclerosis \[MS\].

Secondary objectives were:

* To assess the effect of the two doses in comparison to interferon beta-1a on:

  * Frequency of relapses,
  * Fatigue,
  * Participant's satisfaction with treatment.
* To evaluate the safety and tolerability of the two doses in comparison to interferon beta-1a.

The study consisted of a core treatment period with a common end date defined as 48 weeks after randomization of the last participant, followed by an optional long-term extension treatment period until teriflunomide is commercially available in accordance with local regulations.

Detailed description:
The core treatment period per participant was variable depending on the enrollment in the study (maximum of approximatively 118 weeks). The two doses of teriflunomide were administered in double-blind fashion, whereas interferon beta-1a (Rebif®) was open-label.

The opportunity to continue with the highest dose of teriflunomide in open-label fashion was offered to the participants who successfully completed treatment in the core study.

The overall treatment period was followed by a 4-week elimination follow-up period.

Arms: arm 1: Teriflunomide 7 mg once daily (core treatment period) and teriflunomide 14 mg once daily (extended treatment period). arm 2: Teriflunomide 14 mg once daily (core treatment period) and teriflunomide 14 mg once daily (extension treatment period). arm 3: Interferon β-1a 3 times a week (core treatment period) and teriflunomide 14 mg once daily (extended treatment period).
Interventions: intervention 1: Interferon β-1a intervention 2: Teriflunomide
Intervention descriptions: intervention 1: Sterile preservative-free solution packaged in graduated pre-filled syringes

Subcutaneous injection

Ascending doses from 8.8 to 44 mcg according to local standard for Rebif® intervention 2: Film-coated tablet

Oral administration

Protocol documents:
Clinical trial NCT00892710
Conditions: Non Small Cell Lung Cancer
Keywords: Non small cell lung cancer NSCLC Pemetrexed Bevacizumab Avastin Carboplatin Stage IIIB/IV
Sponsor: SCRI Development Innovations, LLC
Start date: 2009-06-01; Completion date: 2015-05-01
Enrollment: 172 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to evaluate three treatment regimens in patients with stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) with a performance status of 2 and who were not previously treated.

Detailed description:
This randomized, Phase II trial will evaluate three treatment regimens in patients with previously untreated stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) and a performance status (PS) of 2. Patients will be randomized to either pemetrexed alone, pemetrexed and bevacizumab, or pemetrexed, carboplatin, and bevacizumab in a 1:1:1 fashion. All 3 regimens should be tolerable in poor performance status patients with advanced NSCLC. The 3-drug regimen (pemetrexed/carboplatin/bevacizumab) has been modified by lowering the dose of carboplatin, in order to minimize myelosuppression. This trial will be conducted at multiple study sites.

Arms: arm 1: * Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
* Bevacizumab 15 mg/kg IV every 21 days arm 2: * Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
* Bevacizumab 15 mg/kg IV every 21 days
* Carboplatin AUC=5 IV every 21 days arm 3: Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
Interventions: intervention 1: Pemetrexed intervention 2: Bevacizumab intervention 3: Carboplatin
Intervention descriptions: intervention 1: 500 mg/m2 IV given over 10 minutes every 21 days intervention 2: 15 mg/kg IV every 21 days intervention 3: AUC=5 IV every 21 days

Protocol documents:
Clinical trial NCT00895310
Conditions: Prostate Cancer
Keywords: PSA Ketoconazole Prostate Cancer Hormone Refractory Chemotherapy Regimen
Sponsor: University of California, Davis
Start date: 2009-05-01; Completion date: 2015-05-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to test the safety of ketoconazole and how well it works after chemotherapy has been used. Ketoconazole at lower doses has been used for fungal infections however has not yet been approved by the Food and Drug Administration for use in prostate cancer. Ketoconazole has been used for many years at high doses for prostate cancer, and this study will be to look at use of lower dose ketoconazole after someone has received chemotherapy. Ketoconazole works by halting the production of steroids in your body, including testosterone, and is thought to work directly on prostate cancer cells in published lab studies.

Detailed description:
The aim of the study is to research the response of low dose ketoconazole in hormone refractory prostate cancer (HRPC) patients who have already undergone chemotherapy as part of their prostate cancer treatment. The hypothesis of the study is that HRPC patients who have been previously treated with chemotherapy will demonstrate objective PSA response rates to low dose ketoconazole, comparable to historical response rates reported in chemotherapy-naïve patients. This is a single arm trial, with all participants given ketoconazole 200mg TID, along with hydrocortisone given at 20mg in the morning, 10mg at night daily. Each cycle will consist of 28 days. The subject's study participation will continue until subject experiences disease progression, unacceptable toxicities, withdraws consent from the study or dies.

Arms: arm 1: Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm
Interventions: intervention 1: Ketoconazole intervention 2: Hydrocortisone
Intervention descriptions: intervention 1: Ketoconazole is taken three times a day by mouth. intervention 2: Hydrocortisone is taken by mouth 20 mg every morning and 10 mg every evening.

Protocol documents:
Clinical trial NCT00903175
Conditions: Renal Cell Carcinoma
Keywords: RAD001 everolimus sunitinib renal cell carcinoma kidney cancer metastatic renal cell cancer advanced kidney cancer
Sponsor: Novartis Pharmaceuticals
Start date: 2009-10-01; Completion date: 2015-05-01
Enrollment: 471 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study assessed the efficacy and safety of first-line RAD001 followed by second-line sunitinib versus the opposite sequence: first-line sunitinib followed by second-line RAD001 for the treatment of patients with MRCC.

Detailed description:

Arms: arm 1: everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) arm 2: sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
Interventions: intervention 1: everolimus intervention 2: sunitinib
Intervention descriptions: intervention 1: Everolimus was administered orally at 10 mg/day. Everolimus is formulated as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets. intervention 2: Sunitinib was administered orally 50 mg daily, on a schedule of 4 weeks on/2 weeks off. Sunitinib was supplied as hard gelatin capsules of 12.5 mg, 25 mg, or 50 mg strength according to local practice.

Protocol documents:
Clinical trial NCT00941330
Conditions: Breast Cancer
Keywords: Breast, Male Breast, Female
Sponsor: Emory University
Start date: 2009-07-01; Completion date: 2015-05-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The patients are being asked to take part in this study because they have a hormone receptor-positive breast cancer (contains estrogen and/or progesterone receptors) and their doctor has told them that they have an option to receive chemotherapy or hormonal therapy before surgery. The purpose of this study is to assess if chemotherapy using docetaxel and cytoxan (TC) or hormonal therapy using exemestane can shrink the size of their breast tumor and allow them to preserve the breast or have less extensive surgery on their breast.

Detailed description:
The purpose of this study is to assess if chemotherapy using docetaxel and cytoxan (TC) or hormonal therapy using exemestane can shrink the size of your breast tumor and allow you to preserve your breast or have less extensive surgery on your breast. Additionally, by receiving chemotherapy or hormonal therapy before surgery, we will be able to determine if the treatment you receive is effective in treating your cancer. Prior to entering this study, a special test, called the Oncotype DX assay, will be performed on a small amount of your cancer from the biopsy you had at the time you were diagnosed with breast cancer, to determine the likelihood that your cancer will benefit from and shrink with chemotherapy and hormonal therapy. You will only be eligible to enter this study if the recurrence score of your cancer determined using the Oncotype DX assay is less than or equal to 24. Patients with hormone receptor-positive breast cancers with recurrence scores less than or equal to 24 have been previously demonstrated to obtain a larger benefit from hormonal therapy, compared to chemotherapy, when these agents are given after surgery. The ability of hormonal agents and chemotherapy to shrink cancers prior to surgery has not been specifically examined in hormone receptor-positive cancers with recurrence scores less than or equal to 24.

Arms: arm 1: ARM A: Patients will be treated with exemestane. arm 2: ARM B: Patients will be treated with docetaxel and cytoxan.
Interventions: intervention 1: Exemestane intervention 2: Docetaxel intervention 3: Cytoxan
Intervention descriptions: intervention 1: 25 mg daily by mouth for 6 to 12 months. intervention 2: Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks). intervention 3: Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).

Protocol documents: