ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00640224
Conditions: Polycystic Ovary Syndrome
Sponsor: Silva Arslanian
Start date: 2005-03-01; Completion date: 2015-07-01
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose is to investigate the effects of 2 different treatments (drospirenone/ethinyl estradiol versus rosiglitazone) on insulin sensitivity and androgen levels, inflammatory markers, vascular markers and bone development in overweight adolescent females with polycystic ovary syndrome (PCOS).

Detailed description:
The purpose of this study is to:

1\) to compare effects of treatment with drospirenone/ethinyl estradiol (Yasmin)versus rosiglitazone (Avandia) on hyperandrogenism, insulin resistance/hyperinsulinemia, adrenal hyperresponsiveness, body composition, chronic inflammation, bone mass and turnover.

OCPs are the first-line therapy for PCOS, however, they do not address the insulin resistance or the inflammation. Insulin sensitizers have been used successfully to treat PCOS but thiazolidinediones such as rosiglitazone have not been used in adolescents. Therefore we will investigate the effects of treatment with drospirenone/ethinyl estradiol versus rosiglitazone in overweight adolescents with PCOS. We will obtain comprehensive evaluations before and 6 months after randomization, to the respective treatment arms to determine the differences between the 2 treatment modalities.

Arms: arm 1: Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone arm 2: Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol arm 3: Overweight adolescent females without PCOS to use as comparison of normal developmental changes. \*No participants were enrolled in this Arm. arm 4: Lean healthy girls without PCOS to serve as controls for the cardiovascular markers. \*No participants were enrolled in this Arm.
Interventions: intervention 1: rosiglitazone intervention 2: drospirenone/ethinyl estradiol
Intervention descriptions: intervention 1: 4 mg daily for 6 months intervention 2: 1 tab (3mg/30mcg) daily for 6 months

Protocol documents:
Clinical trial NCT00660192
Conditions: Refractory Migraine
Keywords: Migraine, refractory migraine, Pain, Botulinum Toxin , Botox
Sponsor: Yale University
Start date: 2008-01-01; Completion date: 2015-07-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The hypothesis of this study is that injection of botulinum toxin A into the muscles around the head (frontal, temporal, posterior neck, occipital) can reduce the intensity and frequency of migraine headaches by 50%.

Detailed description:
Contact PI for study details

Arms: arm 1: Subjects are randomized to receive Placebo which is inactive saline (sterile salt water solution). The Subjects are injected with a comparable amount of placebo solution (2cc-3cc) as received by those randomized to receive active study drug. The randomization will be done in a double blinded manner where the investigator nor the subject knows which substance (Placebo vs. Botox) is being injected. arm 2: Subjects are randomized to receive Active study drug Botox (onobotulinumtoxinA). The Botox is prepare by diluting 100units of toxin /1cc Saline. The Subjects are injected with 200-300units of units of Botox which is 2cc-3cc of solution. The randomization will be done in a double blinded manner where the investigator nor the subject knows which substance (Placebo vs. Botox) is being injected.
Interventions: intervention 1: Botox intervention 2: Placebo
Intervention descriptions: intervention 1: subjects randomized to receive Botox with have a series of injections of onobotulinumtoxinA totalling 200 to 300 units. Botox is prepared b adding 1cc of preservative free saline in 100 unit vial. Final dose is determined by bod and neck size. intervention 2: subjects randomized to receive Placebo will have a series of injections of saline solution totalling 2cc's to 3cc's injected into the scalp in a halo pattern; and into affected neck muscles.

Protocol documents:
Clinical trial NCT00835900
Conditions: Smoking Cessation
Keywords: smoking cessation varenicline smoking cessation treatment
Sponsor: Roswell Park Cancer Institute
Start date: 2009-03-01; Completion date: 2015-07-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to explore the use of an prolonged alternative dosing schedule using varenicline for smoking cessation leading to greater quit rates and higher rates of continuous abstinence.

Detailed description:
This pilot study will utilize a two group randomized design. Adult smokers who are motivated to quit smoking will be randomized to one of two treatment groups. Both groups will receive brief support counseling. During a one-week baseline and the 4-week pre-quit period smoking rate, smoking satisfaction, withdrawal, and craving will be assessed on a daily basis.

Arms: arm 1: drug plus counseling. arm 2: placebo plus counseling
Interventions: intervention 1: varenicline intervention 2: placebo
Intervention descriptions: intervention 1: variable dosing schedule intervention 2: placebo

Protocol documents:
Clinical trial NCT00845507
Conditions: Weight Gain
Keywords: weight gain
Sponsor: University of Cincinnati
Start date: 2008-12-01; Completion date: 2015-07-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to test the safety and efficacy (how well it works) of exenatide as a treatment for weight gain associated with olanzapine in obese adults with Bipolar Disorder, Major Depressive Disorder, Schizophrenia or Schizoaffective Disorder

Exenatide has been approved by the FDA for the treatment of Type 2 diabetes.

It has not been approved for the treatment of weight gain associated with olanzapine in obese adults with bipolar disorder, Major Depressive Disorder, Schizophrenia or Schizoaffective Disorder

Detailed description:
Double-blind studies suggest that olanzapine is highly effective for the treatment of individuals with bipolar disorder. However, weight gain and impaired glucose tolerance remain significant concerns associated with olanzapine. Exenatide is an anti-diabetic medication that is associated with weight loss and improved glucose regulation. Therefore, the overall goal of the proposed study is to conduct a 16-week double-blind placebo-controlled study of exenatide for the treatment of weight gain associated with olanzapine in 60 obese adults with bipolar disorder treated with olanzapine. We propose to conduct the study over the course of 24 months, with an expected enrollment of approximately 3 patients per month. The primary outcome measure will be change from baseline to endpoint in weight. The secondary outcome measures will include changes from baseline to endpoint, in body mass index (BMI), abdominal circumference, metabolic parameters, clinical global improvement of psychiatric symptoms, and change in manic, depressive and psychotic symptoms. Rates of adverse events also will be assessed.

Arms: arm 1: Exenatide dstarted at 5 mcg subcutaneously twice daily within one hour before the morning and evening meals, and increased (as tolerated) to 10 mcg. arm 2: Placebo: Sterile solution in equivalent doses as Exenatide
Interventions: intervention 1: Exenatide intervention 2: Placebo
Intervention descriptions: intervention 1: The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily. intervention 2: Placebo: Sterile solution in equivalent doses as Exenatide

Protocol documents:
Clinical trial NCT00856245
Conditions: Non-Hodgkins Lymphoma
Keywords: non-Hodgkins lymphoma stem cell transplant
Sponsor: University of Kansas Medical Center
Start date: 2009-02-01; Completion date: 2015-07-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Researchers hope to learn if adding rituximab with high doses of chemotherapy and stem cell transplantation will help patients get rid of their lymphoma cells from the bone marrow and stem cell collections.

Detailed description:
Following the first relapse, patients with follicular type of Non-Hodgkin's lymphoma may have an option to receive high dose chemotherapy followed by autologous (from you) blood stem cell transplantation. One of the common causes of relapse is persistence of lymphoma cells in the bone marrow and in the collected stem cell products.

Patients who do not have a complete response after traditional chemotherapy, have a greater chance of the lymphoma returning even after receiving high dose chemotherapy with stem cell transplantation. In order to improve the response and decrease the relapse rate, additional therapy may be used to kill the lymphoma cells by using antibodies both before and after the transplantation. Antibodies are protein made by white cells in our body to fight off infection and sometimes tumor. Rituxan (rituximab) is an antibody that is effective against your type of lymphoma. Researchers have reported that patients show an improved response and a lower chance of relapse when using rituximab with high dose chemotherapy with autologous stem cell transplantation. It is unknown how effective rituximab is in clearing persistence of minimal remaining disease in patients with follicular lymphoma.

Arms: arm 1: Patients will be treated IV with rituximab at the rate of 50 milligrams per hour (mg/hour) for 1 hour. If patient tolerates the infusion, the rate is increased by increments of 50 mg/hour every 30 minutes to a maximum of 400 mg/hour. If patient has a severe reaction, the infusion is stopped temporarily and the infusion rate is decreased by 50%. Subsequent infusions are started at the rate of 100 mg/hour, increased by 100 mg/hour every 30 minutes to a maximum of 400 mg/hour if tolerated. Vital signs are monitored every 15 minutes for 2 hours and every 30 minutes thereafter.
Interventions: intervention 1: Rituximab
Intervention descriptions: intervention 1: 375 MG/M2 (milligram per meter squared) given IV (intravenously) weekly x 4-8 doses.

Protocol documents:
Clinical trial NCT00876460
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Boehringer Ingelheim
Start date: 2009-03-01; Completion date: 2015-07-01
Enrollment: 43 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To confirm the safety of BIBF 1120 at a dose level up to 200 mg x 2/day (i.e., overseas recommended Phase III dose for combination treatment) with standard therapy of docetaxel (60 mg/m2 and 75 mg/m2) in Japanese advanced non small cell lung cancer (NSCLC) patients with stage IIIB/IV or recurrent after failure of first line chemotherapy and to determine the recommended dose for the Phase II trial.

Detailed description:

Arms: arm 1: Low, medium and high dose of BIBF 1120 and 60 mg/m2, 75 mg/m2 docetaxel every 3 weeks
Interventions: intervention 1: BIBF 1120 M + docetaxel M intervention 2: BIBF 1120 M + docetaxel H intervention 3: BIBF 1120 H + docetaxel H intervention 4: BIBF 1120 L + docetaxel M intervention 5: BIBF 1120 H + docetaxel M
Intervention descriptions: intervention 1: BIBF 1120 Medium dose bid + docetaxel 60 mg/m2 intervention 2: BIBF 1120 Medium dose bid + docetaxel 75mg/m2 intervention 3: BIBF 1120 HIgh dose bid + docetaxel 75 mg/m2 intervention 4: BIBF 1120 Low dose bid + docetaxel 60 mg/m2 intervention 5: BIBF 1120 HIgh dose bid + docetaxel 60 mg/m2

Protocol documents:
Clinical trial NCT00878436
Conditions: Prostate Cancer Prostatic Neoplasms
Keywords: histone deacetylase inhibitor hormone therapy androgen-independent PSA androgen receptor
Sponsor: NYU Langone Health
Start date: 2009-06-01; Completion date: 2015-07-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is designed to investigate the safety, dosing schedule, and efficacy of the combination treatment of Panobinostat (a histone deacetylase inhibitor) and hormone therapy for recurrent prostate cancer. This trial is at its Phase II stage. As of July 23, 2013 Arm B was closed to accrual, all the remaining slots in accrual will be allocated to Arm A.

Detailed description:
The preclinical data indicate that Panobinostat restores the sensitivity of androgen-independent cells to bicalutamide (Casodex®) and the combination has synergistic inhibitory activity. Here, we hypothesize that treatment of castration-resistant patients with Panobinostat will enhance the response to the second line hormone therapy with bicalutamide (Casodex®). In the proposed phase I study, the maximum tolerated dose of tri-weekly, intermittent oral Panobinostat at three different dose levels (60, 90, 120 mg/week) in combination with Casodex (50mg PO) will be determined; The following phase II study will evaluated the efficacies of 9-month treatments of the selected Panobinostat-Casodex combination and also a lower dose of Panobinostat. We expect that Casodex-Panobinostat combination treatment of castration-resistant patients will prevent biochemical and/or metastatic disease progression of these patients compared to historical controls in the same time period.

Arms: arm 1: Each treatment cycle has 21 days:

Bicalutamide (Casodex®) 50mg P.O. daily, continuously, with the addition of:

40 mg Panobinostat 3 times per week (120 mg per week) for 2 consecutive weeks with one week rest arm 2: Each treatment cycle has 21 days:

Bicalutamide (Casodex®) 50mg P.O. daily, continuously, with the addition of:

20 mg Panobinostat 3 times per week (60 mg per week) for 2 consecutive weeks with one week rest
Interventions: intervention 1: Panobinostat intervention 2: Bicalutamide
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00965419
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Eli Lilly and Company
Start date: 2009-09-01; Completion date: 2015-07-01
Enrollment: 267 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of the study is to assess long-term safety and tolerability of Edivoxetine in pediatric participants with attention deficit hyperactive disorder (ADHD).

Detailed description:

Arms: arm 1: All enrolled participants were administered starting dose of 0.1 milligram per kilogram per day (mg/kg/day), or participant specific known stable dose, rollover participants (LNBJ \[No NCT number\]) and (LNBF \[NCT00922636\]), up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Interventions: intervention 1: Edivoxetine
Intervention descriptions: intervention 1: 0.1 mg/kg/day or participant specific known stable dose, rollover participants (LNBJ \[No NCT number\]) and (LNBF \[NCT00922636\]), up to 0.3 mg/kg/day, oral, daily for up to 5 years.

Protocol documents:
Clinical trial NCT00981305
Conditions: Sexual Dysfunction Breast Cancer Survivors
Keywords: dyspareunia breast cancer sexual dysfunction vaginal lubricant
Sponsor: Seoul National University Hospital
Start date: 2009-09-01; Completion date: 2015-07-01
Enrollment: 136 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether lactate-containing vaginal lubricant is effective in the treatment of young breast cancer survivors with sexual dysfunction.

Detailed description:
Study scheme

* study arm: apply lactate-containing lubricants at the time of sexual intercourse and before sleep at least 3 times per a week for 8 weeks
* control arm: placebo apply

Outcome measures

* Female Sexual function Index (FSFI-20): at 0 wk and at 8 wk
* vaginal maturation index: at 0 wk and 8 wk
* vaginal pH: at 0 wk and 8 wk

Arms: arm 1: apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week) arm 2: apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)
Interventions: intervention 1: Lactate-containing vaginal lubricant intervention 2: Placebo vaginal lubricant
Intervention descriptions: intervention 1: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week) intervention 2: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)

Protocol documents:
Clinical trial NCT01006980
Conditions: Malignant Melanoma
Sponsor: Hoffmann-La Roche
Start date: 2010-01-01; Completion date: 2015-07-01
Enrollment: 675 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, open-label study evaluated the efficacy, safety and tolerability of vemurafenib (RO5185426) as compared to dacarbazine in previously untreated patients with metastatic melanoma. Patients were randomized to receive either vemurafenib 960 mg orally twice daily or dacarbazine 1000 mg/m2 intravenously every 3 weeks. Study treatment was continued until disease progression or unacceptable toxicity occurred. The data and safety monitoring board recommended that patients in the dacarbazine group be allowed to cross over to receive vemurafenib, and the protocol was amended accordingly on January 14, 2011, as both overall survival and progression-free survival endpoints had met the prespecified criteria for statistical significance in favor of vemurafenib.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Vemurafenib intervention 2: Dacarbazine
Intervention descriptions: intervention 1: 960 mg (as 240 mg tables) orally twice daily intervention 2: 1000 mg/m2 intravenously every 3 weeks

Protocol documents:
Clinical trial NCT01042288
Conditions: Non-Small-Cell Lung Cancer
Keywords: Non-Small-Cell Lung Cancer NSCLC Panitumumab Vectibix Pemetrexed Alimta Carboplatin
Sponsor: SCRI Development Innovations, LLC
Start date: 2010-06-01; Completion date: 2015-07-01
Enrollment: 70 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this multicenter, Phase II trial is to examine the role of a well-tolerated novel agent, panitumumab, in combination with a modern platinum doublet regimen using carboplatin and pemetrexed, in patients with advanced non-squamous wild type K-ras non-small-cell lung cancer (NSCLC). If this treatment proves to be well tolerated and associated with efficacy, this would provide rationale for further randomized studies.

Detailed description:

Arms: arm 1: Systemic Therapy
Interventions: intervention 1: Carboplatin intervention 2: Pemetrexed intervention 3: Panitumumab
Intervention descriptions: intervention 1: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length) intervention 2: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length) intervention 3: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)

Protocol documents:
Clinical trial NCT01063348
Conditions: Pathologic Skin Picking Neurotic Excoriation Psychogenic Excoriation Dermatillomania
Keywords: N-Acetyl Cysteine Picking Impulse Control Disorder Obsessive Compulsive Disorder
Sponsor: University of Chicago
Start date: 2012-09-01; Completion date: 2015-07-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of the proposed study is to evaluate the comparative efficacy of N-acetyl cysteine to placebo in pathologic skin picking. Thirty subjects with pathologic skin picking will receive 12 weeks of double-blind treatment with N-acetyl cysteine or matching placebo. The hypothesis to be tested is that N-acetyl cysteine will be more effective than placebo in patients with pathologic skin picking. The proposed study will provide needed data on the treatment of an often disabling disorder that currently lacks a clearly effective treatment.

Detailed description:
Pathologic skin picking involves repetitive, ritualistic, or impulsive picking of otherwise normal skin leading to tissue damage, personal distress, and impaired functioning. Although skin picking has been described in the medical literature for over one-hundred years, it remains a poorly understood psychiatric issue and often goes undiagnosed and untreated.

Picking behavior does not by itself suggest a psychiatric disorder. Pathology exists in the focus, duration and extent of the behavior, as well as the reasons for picking, associated emotions, and resulting problems. Patients with PSP report thoughts of picking or impulses to pick that are irresistible, intrusive and/or senseless. These thoughts, impulses, or behaviors also cause marked distress for patients and significantly interfere with other activities. Unlike normal picking behavior, the pathologic form of skin picking is recurrent and usually results in noticeable skin damage.

Thirty subjects with pathologic skin picking will receive 12 weeks of double-blind treatment with N-acetyl cysteine or matching placebo. The hypothesis to be tested is that N-acetyl cysteine will be more effective than placebo in patients with pathologic skin picking. The proposed study will provide needed data on the treatment of an often disabling disorder that currently lacks a clearly effective treatment.

Arms: arm 1: N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd) arm 2: Matching placebo taken daily
Interventions: intervention 1: N-Acetyl Cysteine intervention 2: Placebo
Intervention descriptions: intervention 1: Week 0 (Visit 1) - Week 3 (V2): 1200mg/day (600mg po qam and 600mg po qpm) Week 3 (V2) - Week 6 (V3): 2400mg/day (1200mg po qam and 1200mg po qpm) Week 6 (V4) - Week 12 (V5): 3000mg/day (1200mg po qam and 1800mg po qpm) intervention 2: Matching placebo capsules taken in same amount of pills as the active medication.

Protocol documents:
Clinical trial NCT01077544
Conditions: Chronic Myeloid Leukemia Acute Lymphoblastic Leukemia
Keywords: Chronic Myeloid Leukemia Acute Lymphoblastic Leukemia Ph+ CML Ph+ ALL pediatric nilotinib imatinib chronic phase accelerated phase newly diagnosed Ph+ CML dasatinib
Sponsor: Novartis Pharmaceuticals
Start date: 2011-04-14; Completion date: 2015-07-01
Enrollment: 15 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the pharmacokinetics of nilotinib in Ph+ CML pediatric patients that are newly diagnosed or resistant or intolerant to imatinib or dasatinib or refractory or relapsed Ph+ ALL compared to the adult populations. It will also evaluate safety and activity of nilotinib as secondary objectives.

Detailed description:

Arms: arm 1: 1 year to \< 10 years pediatric patients with newly diagnosed CP-Ph+ CML, or CP or AP-Ph+ CML resistant/intolerant to imatinib and/or dasatinib, or relapsed/refractory Ph+ ALL (acute lymphoblastic leukemia) treated at the proposed dose of 230 mg/m2 bid. arm 2: \>= 10 years to \<18 years pediatric patients with newly diagnosed CP-Ph+ CML, or CP or AP-Ph+ CML resistant/intolerant to imatinib and/or dasatinib, or relapsed/refractory Ph+ ALL (acute lymphoblastic leukemia) treated at the proposed dose of 230 mg/m2 bid.
Interventions: intervention 1: Nilotinib
Intervention descriptions: intervention 1: Nilotinib capsules were delivered in bottles with dose strengths of 50mg, 150mg and 200mg.

Patients were administered nilotinib 230 mg/m2 (per BSA) bid, orally, rounded to the nearest 50 mg (max single dose 400 mg) for 28 days (1 cycle) for up to 12 cycles prior to protocol amendment 3 and up to 24 cycles post amendment 3. Capsules were to be swallowed whole with water. Apple sauce (puréed apple) may have been used as a vehicle for dosing where capsules were not able to be swallowed whole with water.

Protocol documents: