ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01510756
Conditions: Chronic Lymphocytic Leukemia
Sponsor: Thomas Kipps
Start date: 2011-12-01; Completion date: 2014-12-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 2 trial to evaluate the activity of sorafenib in relapsed or refractory CLL patients with an iwCLL-WG indication to receive therapy.

Sorafenib is an orally active multikinase inhibitor, which targets the RAF/MEK/ERK signaling pathway as well as several receptor tyrosine kinases. It is FDA approved for the treatment of hepatocellular carcinoma and renal cell carcinoma. Preclinical studies in the investigators laboratory demonstrated that sorafenib is cytotoxic to CLL cells.

The primary objective of the study is to determine the overall response rate of Sorafenib in previously treated CLL patients. All patients will receive sorafenib at 400 mg twice daily continuously for three months and then assessed for response. Responding patients may elect to continue on treatment for an additional 9 months.

Detailed description:
The UCSD Moores Cancer is conducting a Phase 2 clinical trial to evaluate the activity of sorafenib in relapsed or refractory CLL patients.

Sorafenib (BAY 43-9006) is an oral multi-kinase inhibitor with effects on tumor proliferation and tumor angiogenesis. It was initially selected based on inhibition of the serine/threonine kinases Raf-1 and wild-type B-Raf, which are pivotal components of the Ras/Raf/MEK/ERK signaling pathway. CLL cells derive survival support from their microenvironment, in part by activation of this pathway. Preclinical studies performed in our lab demonstrated that sorafenib was cytotoxic to CLL cells, including those from patients with more aggressive disease and from patients with chemotherapy (fludarabine) resistant disease.

The purpose of this study is to evaluate for evidence of anti-leukemic activity / clinical activity of sorafenib by assessing decrease in absolute lymphocyte count (ALC)/leukemia cell counts, lymphadenopathy, splenomegaly, and leukemia infiltration of bone marrow and to assess the impact of sorafenib on the CLL B cells through corollary studies. Patients will continue treatment for up to 3 monthly cycles unless toxicity or progressive disease. Patients with noted stable disease (or better) in the absence of significant toxicity will be allowed to receive another 1-9 cycles of single agent sorafenib. All patients will be assessed for response following 3 cycles of treatment and/or following all therapy per iwCLL-WG 2008 guidelines.

Arms: arm 1: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days).
Interventions: intervention 1: Sorafenib
Intervention descriptions: intervention 1: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles.

Protocol documents:
Clinical trial NCT01511315
Conditions: Psoriasis
Keywords: Moderate to severe psoriasis
Sponsor: University of California, San Francisco
Start date: 2012-03-01; Completion date: 2014-12-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study aims to see if patient quality of life can be approved after treatment with an injectable medication called ustekinumab for the treatment of generalized psoriasis. The investigators hypothesize that the investigators will see improvement in quality of life.

Detailed description:
The primary objective of this study is to demonstrate improvement in psoriasis patient quality of life after 36 weeks with ustekinumab through the use of validated dermatologic and non-dermatologic psychometric instruments.

Arms: arm 1: None
Interventions: intervention 1: Ustekinumab
Intervention descriptions: intervention 1: Biologic agent: sub-cutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter.

Protocol documents:
Clinical trial NCT01511536
Conditions: Prostate Cancer
Sponsor: Sanofi
Start date: 2012-03-01; Completion date: 2014-12-01
Enrollment: 38 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objectives:

* To determine the maximum tolerated dose, and dose limiting toxicities of cabazitaxel administered as a 1-hour infusion every 3 weeks in combination with oral daily abiraterone acetate and prednisone in participants with metastatic Castrate-resistant prostate cancer (CRPC)
* To estimate the anti-tumor activity of cabazitaxel in combination with abiraterone acetate and prednisone in terms of prostate-specific antigen (PSA) response rate.

Secondary Objectives:

* To characterize the safety profile of the combination
* To evaluate the pharmacokinetic profile of cabazitaxel and abiraterone in the proposed combination and dosing schedule
* To assess preliminary antitumor activity of the combination in terms of progression-free survival, PSA progression free survival and objective response rate, and overall survival

Detailed description:
The study duration was to include a period for inclusion of up to 3 weeks and a 3-week treatment cycle(s). The participants might continue treatment until disease progression, unacceptable toxicity or willingness to stop followed by a minimum of 30-day follow-up

Arms: arm 1: Cabazitaxel 20 mg/m\^2 intravenous (IV) infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal. arm 2: Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal. arm 3: Cabazitaxel at maximum tolerated dose (MTD) as determined in phase 1 part (25 mg/m\^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
Interventions: intervention 1: Cabazitaxel XRP6258 intervention 2: Abiraterone acetate intervention 3: Prednisone 5 mg
Intervention descriptions: intervention 1: Pharmaceutical form:solution Route of administration: injection intervention 2: Pharmaceutical form:tablets Route of administration: oral intervention 3: Route of administration: oral

Protocol documents:
Clinical trial NCT01517893
Conditions: Vitiligo
Keywords: vitiligo simvastatin
Sponsor: John Harris
Start date: 2012-01-01; Completion date: 2014-12-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators purpose is to initiate a phase II, randomized, placebo-controlled clinical trial to test simvastatin, an FDA-approved medication for hypercholesterolemia, as a new treatment for vitiligo. The aims of this placebo-controlled study seek to determine the safety and potential efficacy of simvastatin 80mg daily versus placebo in adult male patients with generalized vitiligo. Additionally, the investigators will collect blood to examine the effect of simvastatin on autoreactive CD8+ T cells in vitiligo patients.

Detailed description:
Vitiligo is an autoimmune disease caused by autoreactive CD8+ T lymphocytes that target melanocytes, and interferon-γ-induced CXCL10 plays an important role.1 Simvastatin inhibits interferon-γ signaling by blocking activation of STAT12 and prevented and reversed disease in our mouse model.3 A case report described a patient with vitiligo who repigmented with simvastatin.4 We conducted a small, randomized, double-blind, placebo-controlled, phase II clinical trial to test simvastatin as a treatment for vitiligo. After obtaining informed consent, we enrolled men ages 18 to 64 years with vitiligo affecting 3% to 50% of their body surface area (BSA). We excluded patients with a segmental presentation; those already taking 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitor; those with existing thyroid disease; and women, based on their increased risk of simvastatin-induced myopathy.

Arms: arm 1: Sig: Simvastatin 40 mg, increased to 80 mg after 1 month if initial dose tolerated arm 2: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated
Interventions: intervention 1: Simvastatin intervention 2: Placebo
Intervention descriptions: intervention 1: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated intervention 2: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated

Protocol documents:
Clinical trial NCT01534910
Conditions: Metabolic Syndrome
Keywords: garlic ct angiography atherosclerosis carotid IMT
Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Start date: 2012-05-01; Completion date: 2014-12-01
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators will be assessing the effect of Aged Garlic Extract on the coronary arteries. The investigators will enroll patients in a double blind study, where half the patients will receive placebo, and have the patients undergo a series of tests of plaque (CT scan of the heart, carotid ultrasound) and follow the patients on the drug or placebo and then repeat the tests and blood work at the end of one year. The investigators will assess if being on aged garlic extract adds any benefit to plaque in the coronary or neck arteries. The investigators will also assess the effect of aged garlic extract on markers of inflammation. Patients will receive free drug, free testing and be compensated, and learn more about their heart and neck arteries. if successful, more patients can use this drug to benefit their health. The harms include the radiation from the CT scan and the medication, which has mild side effects.

Detailed description:
The investigators will be assessing the effect of Aged Garlic Extract on the coronary arteries. The investigators will enroll patients in a double blind study, where half the patients will receive placebo, and have the patients undergo a series of tests of plaque (CT scan of the heart, carotid ultrasound) and follow the patients on the drug or placebo and then repeat the tests and blood work at the end of one year. The investigators will assess if being on aged garlic extract adds any benefit to plaque in the coronary or neck arteries. The investigators will also assess the effect of aged garlic extract on markers of inflammation. Patients will receive free drug, free testing and be compensated, and learn more about their heart and neck arteries. if successful, more patients can use this drug to benefit their health. The harms include the radiation from the CT scan and the medication, which has mild side effects. The study will perform advanced CT angiography at baseline and follow up along with carotid intimal media thickness testing, to see if plaque is slowed down by Aged Garlic Extract

Arms: arm 1: placebo arm 2: 2400 mg of aged garlic extract
Interventions: intervention 1: aged garlic extract intervention 2: placebo
Intervention descriptions: intervention 1: 2400 mg a day intervention 2: placebo

Protocol documents:
Clinical trial NCT01535235
Conditions: HIV
Keywords: HIV Lymphoid fibrosis
Sponsor: University of California, San Francisco
Start date: 2012-02-01; Completion date: 2014-12-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators propose a proof-of-concept, pathogenesis-oriented, randomized, placebo-controlled pilot study to assess whether the addition of an angiotensin converting enzyme (ACE) inhibitor to standard Highly Active Antiretroviral Therapy (HAART) reverses lymphoid fibrosis, and whether this leads to more effective HIV-specific host immune responses and an accelerated clearance of the latent reservoir.

Detailed description:

Arms: arm 1: Active group arm 2: Placebo group
Interventions: intervention 1: Lisinopril intervention 2: Placebo
Intervention descriptions: intervention 1: Lisinopril 20mg QD x 24 weeks intervention 2: Placebo QD x24wks

Protocol documents:
Clinical trial NCT01537432
Conditions: Psoriasis, Plaque-type Psoriasis
Keywords: Psoriasis, Plaque-type psoriasis Plaque Secukinumab AIN457A PASI DLQI IGA
Sponsor: Novartis Pharmaceuticals
Start date: 2012-01-01; Completion date: 2014-12-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to evaluate the proportion of patients achieving reversal of chronic plaque psoriasis at week 4 and 12 following multiple doses of secukinumab administered subcutaneously (sc) compared to placebo. Starting from week 13, all patients will receive multiple doses of secukinumab up to week 52 to study long term effects of secukinumab. Clinical endpoints including biomarker assessments, PASI, IGA and DLQI will be compared to better understand, why secukinumab may be effective in psoriasis patients.

Detailed description:

Arms: arm 1: placebo arm 2: secukinumab
Interventions: intervention 1: secukinumab intervention 2: placebo
Intervention descriptions: intervention 1: secukinumab intervention 2: placebo comparator

Protocol documents:
Clinical trial NCT01546649
Conditions: Premenopausal Breast Cancer
Sponsor: Takeda
Start date: 2012-04-01; Completion date: 2014-12-01
Enrollment: 167 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Hormone dynamics, pharmacokinetics, safety, and efficacy of TAP-144-SR(6M) will be evaluated against TAP-144-SR(3M) in postoperative and hormone therapy-naïve patients with premenopausal breast cancer

Detailed description:

Arms: arm 1: TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 96 weeks. arm 2: TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 96 weeks.
Interventions: intervention 1: TAP-144-SR(6M) intervention 2: TAP-144-SR(3M)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01582945
Conditions: Major Depressive Disorder
Keywords: Treatment resistant suicidal ideation major depressive disorder
Sponsor: Massachusetts General Hospital
Start date: 2012-04-01; Completion date: 2014-12-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Ketamine infusion has been shown to have rapid antidepressant properties, however the possible use of ketamine in treatment-resistant depression as augmentation has not been investigated. The overall aim of this study is to assess the feasibility, safety and tolerability, efficacy and duration of the effect of intravenous N-methyl-D-aspartate antagonist ketamine as augmentation of antidepressants for chronic suicidal ideation in subjects with severe treatment-resistant depression (TRD).

This is an open-label study (pilot).

Detailed description:
Patients will undergo two weeks of prospective observation, they will then receive ketamine IV 0.5mg/kg over 45 minutes as augmentation of their ongoing antidepressant regimen; after three infusions this dose will be increased increase to 0.75 mg/kg in non-responders. The schedule of administration will be twice a week for 3 weeks. After this phase, the patient will be followed with assessments every two weeks for three months.

Total duration of the study is 5 months.

Arms: arm 1: Patients will receive open label augmentation with IV Ketamine at 0.5mg/kg, twice a week for 3 weeks
Interventions: intervention 1: Ketamine
Intervention descriptions: intervention 1: Ketamine IV 0.5mg/kg infusion twice a week for 3 weeks as augmentation of ongoing antidepressant regimen

Protocol documents:
Clinical trial NCT01586806
Conditions: Anterior Cruciate Ligament Reconstruction Regional Anesthesia, Saphenous Nerve Block
Keywords: Dexamethasone Glucocorticoids Physiological Effects of Drugs Therapeutic Uses Anterior Cruciate Ligament Reconstruction Regional Anesthesia, nerve block Ultrasonic Imaging Post-Operative Complications: muscle weakness, pain, nausea and vomiting Dexamethasone (as local anesthetic additive)
Sponsor: Hospital for Special Surgery, New York
Start date: 2012-07-01; Completion date: 2014-12-01
Enrollment: 195 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
For patients undergoing Anterior Cruciate Ligament reconstruction surgery, the postoperative period can be a painful experience without adequate pain management. Hence the investigators propose a randomized controlled clinical study, investigating prolonged saphenous nerve blocks. Patients will be randomized to receive saphenous nerve blocks with or without dexamethasone, a corticosteroid used to prolong analgesia.

Depending on the randomized treatment assignment, patients may receive one of the following:

1. 13 ml of 0.5% bupivacaine, a local anesthetic (no dexamethasone);
2. 13 ml of 0.5% bupivacaine mixed with 1 mg of dexamethasone;
3. 13 ml of 0.5% bupivacaine mixed with 4 mg of dexamethasone.

Patients will be followed postoperatively. Following admission to the recovery room, data collectors will ask patients to rate their pain on a scale of 0-10 until discharge. Data collectors will also record patient satisfaction, pain medication use and any side effects experienced (i.e. nausea and vomiting). Patients will then be contacted on postoperative days 1, 2 and 14 and asked questions about their general well-being.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Bupivacaine Only intervention 2: Bupivacaine with 1 mg of Dexamethasone intervention 3: Bupivacaine with 4 mg of Dexamethasone
Intervention descriptions: intervention 1: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic). intervention 2: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml. intervention 3: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.

Protocol documents:
Clinical trial NCT01588405
Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary Arterial Hypertension UT-15C SR PAH
Sponsor: United Therapeutics
Start date: 2012-04-01; Completion date: 2014-12-01
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This multi-center, open-label study will assess the tolerability and safety of transitioning subjects with stable Pulmonary Arterial Hypertension (PAH) from continuous intravenous (IV) or subcutaneous (SC) Remodulin infusion to oral treprostinil (UT-15C sustained release (SR) tablets).

This study will consist of an in-hospital transition phase, dose optimization/evaluation phase, and follow up phase.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: UT-15C SR
Intervention descriptions: intervention 1: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.

Protocol documents:
Clinical trial NCT01600885
Conditions: NMDA Receptor Function
Keywords: Guanfacine Ketamine Functional Magnetic Resonance Imaging Prefrontal Cortex Activity Receptors, N-Methyl-D-Aspartate Receptors, Adrenergic, alpha-2 Memory, Short-Term Schizophrenia
Sponsor: Yale University
Start date: 2008-08-01; Completion date: 2014-12-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of the study is

1. To establish the feasibility of fMRI studies of the interaction of guanfacine and ketamine.
2. To explore the possibility that guanfacine can ameliorate the negative effects of ketamine on task-related prefrontal activation.
3. To assess the strength of any interaction between guanfacine and ketamine.

Detailed description:
Potential subjects will be interviewed over the phone and, if appropriate, will be scheduled for a screening session. Participants who meet study criteria will participate in two study sessions separated by at least two weeks. The sessions will be identical except on one day they will receive guanfacine and on the other, they will receive a placebo.

This study was initially completed in 2014. Upon analysis of the collected data, it was decided to add additional subjects and gather additional data to verify results seen in the collected data. The study was reopened and new data was added beginning in September 2016. Information about the study beginning in 2016 is available in a separate record.

Arms: arm 1: During the first study session, the participant will receive guanfacine before undergoing a ketamine-infusion fMRI. During the second study session, at least two weeks later, the participant will receive a placebo before undergoing a ketamine-infusion fMRI. arm 2: During the first study session, the participant will receive a placebo before undergoing a ketamine-infusion fMRI. During the second study session, at least two weeks later, the participant will receive guanfacine before undergoing a ketamine-infusion fMRI.
Interventions: intervention 1: Guanfacine intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects will be given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) will be given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant will receive a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation will be measured during a spatial working memory task. The entire scan will last approximately two and a half hours and the ketamine infusion will be up to one hour and 15 minutes. intervention 2: Subjects will be given a placebo before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) will be given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant will receive a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation will be measured during a spatial working memory task. The entire scan will last approximately two and a half hours and the ketamine infusion will be up to one hour and 15 minutes.

Protocol documents: