ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00049127
Conditions: Adult Anaplastic Oligodendroglioma Adult Mixed Glioma Adult Oligodendroglioma Recurrent Adult Brain Neoplasm
Sponsor: Alliance for Clinical Trials in Oncology
Start date: 2003-06-01; Completion date: 2019-09-01
Enrollment: 64 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This phase I/II trial is studying the side effects and best dose of imatinib mesylate and to see how well it works in treating patients with a recurrent brain tumor that has not responded to previous surgery and radiation therapy. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To identify the maximum tolerated dose of imatinib (imatinib mesylate) in patients with recurrent oligodendroglioma and mixed oligoastrocytoma that are currently on enzyme inducing anticonvulsant therapy. (Study 1) II. To assess the efficacy of imatinib in patients with recurrent oligodendrogliomas and mixed oligoastrocytomas (with pathologic evidence of oligodendrogliomatous component) as measured by progression-free survival, response, and overall survival. (Study 2) III. To acquire pilot data on a patient group not traditionally eligible for recurrent oligodendroglioma and mixed oligoastrocytoma clinical trials (those having \> 2 prior chemotherapy regimens or 2 prior chemotherapy regimens for recurrent/progressive disease). (Study 3) IV. To examine the toxicity and safety of imatinib in patients with recurrent oligodendrogliomas and mixed oligoastrocytomas (with pathologic evidence of oligodendrogliomatous component). (Studies 1, 2, and 3) V. To perform a preliminary correlative study of 1p/19q alterations, alpha platelet-derived growth factor receptor (PDFGR) gene amplification and levels of related downstream signaling elements in tumor tissue, with clinical study endpoints. (Studies 1, 2, and 3) VI. To perform a descriptive correlative analysis of steady state pharmacokinetic data regarding imatinib and active metabolites with the study endpoints. (Studies 1, 2, and 3)

OUTLINE: This is a phase I, dose-escalation study followed by a phase II and a pilot study.

Arms: arm 1: Patients receive imatinib mesylate PO, at the MTD determined in phase I, BID for 4 weeks. arm 2: Patients receive standard-dose imatinib mesylate PO BID for 4 weeks.
Interventions: intervention 1: Imatinib Mesylate intervention 2: Laboratory Biomarker Analysis intervention 3: Pharmacological Study
Intervention descriptions: intervention 1: Given PO intervention 2: Optional correlative studies intervention 3: Optional correlative studies

Protocol documents:
Clinical trial NCT04176224
Conditions: Japanese Patients With ALS
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2019-04-17; Completion date: 2019-09-04
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the pharmacokinetics of single doses of edaravone oral suspension in Patients with Amyotrophic Lateral Sclerosis

Detailed description:

Arms: arm 1: Patients receive the edaravone oral suspension.
Interventions: intervention 1: MT-1186
Intervention descriptions: intervention 1: Suspension

Protocol documents:
Prot_000.pdf: 





















































































































SAP_001.pdf:
Clinical trial NCT03103100
Conditions: Labor Pain
Keywords: Local anesthetic Labor epidural
Sponsor: University of Alabama at Birmingham
Start date: 2015-10-08; Completion date: 2019-09-09
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare and determine the most ideal local anesthetic (LA) solution to activate a labor epidural: lidocaine, bupivacaine, or a combination of bupivacaine plus lidocaine.

Detailed description:
The most common and effective method for controlling labor pains is a local anesthetic (LA) infusion through a lumbar epidural. To achieve adequate pain control during the first stage of labor - onset of contractions to complete cervical dilation - nerve fibers up to the T10 dermatome must be anesthetized. When a patient is in active labor and an epidural catheter is placed, the anesthesiologist must activate the epidural by administering LA through the epidural to promote spread of the LA in the epidural space to anesthetize the nerve fibers involved in the conduction of labor pains. The ideal LA to achieve this goal is one that would allow for the fastest onset to achieve quick pain relief with the fewest side effects.

Two commonly used LA to provide labor analgesia are bupivacaine and lidocaine. When low concentrations - 0.25% bupivacaine and 1% lidocaine - are used for labor analgesia, both of these LA can be administered safely with very little concern of major adverse effects associated with LA toxicity. Given that there is limited and conflicting evidence for the usefulness of the bupivacaine and lidocaine mixture especially as it relates to labor epidural activation, we hope to readdress these questions in an effort to determine whether or not the LA combination offers any distinct advantage over the individual LA. The investigators intend to determine the time it takes to achieve an adequate level (T10) for labor analgesia, the total spread of local anesthetic, and the degree of motor block as these factors will be important in determining the most optimal LA solution to activate a labor epidural. With the results from this study, the investigators hope to recommend a LA solution that will allow for the fastest pain relief in the laboring mother with the fewest side effects.

Arms: arm 1: Patients randomized into the lidocaine group will receive 10 mL of 1% lidocaine arm 2: Patients randomized into the bupivacaine group will receive 10 mL of 0.25% bupivacaine arm 3: Patients randomized into the bupivacaine group will receive 5 mL of 0.25% bupivacaine and 5 mL of 1% lidocaine.
Interventions: intervention 1: 1% Lidocaine intervention 2: 0.25% Bupivacaine intervention 3: Bupivacaine plus Lidocaine
Intervention descriptions: intervention 1: 10 mL of 1% lidocaine intervention 2: 10 mL of 0.25% bupivacaine intervention 3: 5 mL of 1% lidocaine and 5 mL of 0.25% bupivacaine

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT01943461
Conditions: Solid Tumors
Keywords: Solid Tumors MSB0010718C anti PD-L1 avelumab Phase 1
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2013-09-02; Completion date: 2019-09-25
Enrollment: 57 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This was a Phase 1, open-label, dose-escalation trial of avelumab (antibody targeting programmed death ligand 1 \[anti PD-L1\]) in Japanese participants with metastatic or locally advanced solid tumors, followed by a consecutive expansion part in Asian participants with gastric cancer.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Avelumab 3 mg/kg intervention 2: Avelumab 10 mg/kg intervention 3: Avelumab 20 mg/kg
Intervention descriptions: intervention 1: Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 3 milligrams per kilogram (mg/kg) once every 2 weeks in the dose- escalation cohort until disease progression, unacceptable toxicity or withdrawal from the study or study drug occurred. intervention 2: Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 10 mg/kg once every 2 weeks in the dose- escalation cohort and expansion cohort until disease progression, unacceptable toxicity or withdrawal from the study or study drug occurred. intervention 3: Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 20 mg/kg once every 2 weeks in the dose- escalation cohort until disease progression, unacceptable toxicity or withdrawal from the study or study drug occurred.

Protocol documents:
Clinical trial NCT04964193
Conditions: Drug Use
Keywords: cyproterone acetate ethinyl estradiol bioequivalence cross-over design study pharmacokinetics Indonesian healthy female
Sponsor: PT Sydna Farma
Start date: 2019-03-12; Completion date: 2019-09-26
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study was conducted to investigate whether 2 mg cyproterone acetate (CPA) and 0.035 mg ethinyl estradiol (EE) film-coated tablet (Elzsa®) manufactured by PT. Sydna Farma was bioequivalent to its reference product, Diane®-35 sugar-coated tablet manufactured by Bayer Weimar GmbH, Germany, imported by PT. Bayer Indonesia, Depok, Indonesia.

Detailed description:
Twenty four healty female subjects were given a single dose of Elzsa® FCT or or Diane®-35 with 240 mL of water. Then the blood samples for CPA and EE were drawn and analyzed using LCMS/MS. All subjects sample plasma were analyzed for pharmacokinetic evaluation

Arms: arm 1: Participants received Elzsa film-coated tablet (2 mg cyproterone acetate + 0.035 mg ethinylestradiol) with 240 mL of water arm 2: Participants received Diane-35 Sugar-coated tablet ( 2 mg cyproterone acetate + 0.035 mg ethinylestradiol) with 240 mL of water
Interventions: intervention 1: Elzsa film-coated tablet intervention 2: Diane-35 Sugar-coated tablet
Intervention descriptions: intervention 1: Administered with 240 mL of water intervention 2: Administered with 240 mL of water

Protocol documents:
Prot_SAP_001.pdf:
Clinical trial NCT03520036
Conditions: Erythropoietic Protoporphyria (EPP)
Sponsor: Mitsubishi Tanabe Pharma America Inc.
Start date: 2018-07-05; Completion date: 2019-09-28
Enrollment: 102 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the efficacy and safety of MT-7117 on sunlight exposure duration without symptoms and tolerance in subjects with EPP.

Detailed description:
This is a Phase 2, randomized, double-blind, placebo controlled study to assess the efficacy, tolerability, and safety of MT-7117 in subjects with EPP. The study consists of a 2 week screening period, a 16 week double-blind treatment period, and a 6 week follow-up period at Week 22. The total participation period is approximately 24 weeks.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: MT-7117 low dose intervention 2: MT-7117 high dose intervention 3: Placebo
Intervention descriptions: intervention 1: MT-7117 low dose QD, oral, 16 weeks intervention 2: MT-7117 high dose QD, oral, 16 weeks intervention 3: Placebo QD, oral, 16 weeks

Protocol documents:
Prot_000.pdf: 

























































































































































































































SAP_001.pdf:
Clinical trial NCT02837042
Conditions: Penile Squamous Cell Carcinoma
Keywords: penile cancer Pembrolizumab penile squamous cell carcinoma squamous cell cancer
Sponsor: University of Alabama at Birmingham
Start date: 2016-10-01; Completion date: 2019-10-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Penile squamous cell carcinoma (PSCC) is relatively rare but exhibits higher incidences in less developed countries. PSCC is a highly aggressive malignancy characterized by early spread. Pembrolizumab has recently been FDA-approved for the treatment of melanoma but will serve as the investigational agent for this penile cancer study.

Detailed description:
This is a multicenter trial to evaluate Pembrolizumab for patients with advanced penile squamous cell carcinoma following prior chemotherapy. Participating institutions are the University of Alabama at Birmingham (coordinating center), M.D. Anderson Cancer Center, University of Michigan, University of Minnesota, and Emory University. Patients will receive intravenous Pembrolizumab every 3 weeks and undergo a clinical exam. Radiographic scans will be done at baseline and every 9 weeks. Therapy will continue until disease progression or there are intolerable toxicities.

Arms: arm 1: Once eligibility is confirmed, the patient will start treatment cycles with Pembrolizumab at 200 mg given intravenously on the first day of each cycle. Each cycle corresponds to a duration of 3 weeks.
Interventions: intervention 1: Pembrolizumab
Intervention descriptions: intervention 1: Pembrolizumab will be administered intravenously every 3 weeks.

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT00878709
Conditions: Breast Cancer
Keywords: HER-2/erbB-2 positive breast cancer breast cancer adjuvant therapy neratinib HKI-272 Nerlynx PB-272
Sponsor: Puma Biotechnology, Inc.
Start date: 2009-07-09; Completion date: 2019-10-04
Enrollment: 2840 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.

Detailed description:

Arms: arm 1: 240 mg orally daily for one year arm 2: orally daily for one year
Interventions: intervention 1: neratinib intervention 2: placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT03036813
Conditions: Sickle Cell Disease
Sponsor: Pfizer
Start date: 2016-12-01; Completion date: 2019-10-08
Enrollment: 449 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study of Voxelotor Administered Orally to Patients With Sickle Cell Disease

Detailed description:
This is a randomized, placebo-controlled, double blind, parallel group, multicenter study of participants, age 12 to 65 years, with SCD. The key purpose for the study is to establish efficacy and safety of voxelotor as compared with placebo.

Arms: arm 1: voxelotor arm 2: voxelotor arm 3: Placebo
Interventions: intervention 1: voxelotor intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Prot_001.pdf: 



































































































SAP_000.pdf:
Clinical trial NCT03593902
Conditions: Systemic Sclerosis Scleroderma
Keywords: Autologous Stem Cell Transplantation Hematopoietic Stem Cell Transplant
Sponsor: Northwestern University
Start date: 2018-05-17; Completion date: 2019-10-09
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to treat systemic sclerosis (scleroderma) patients with an autologous stem cell transplant using a regimen of immune suppressant drugs and chemotherapy that is less toxic to your heart.

Detailed description:
The autologous hematopoietic stem cell transplant used in this research study is an investigational procedure that uses cyclophosphamide and fludarabine (chemotherapy), rabbit anti-thymocyte globulin (rATG) (a protein that kills the immune cells that are thought to be causing your disease), and rituximab (a biologic drug that targets B cells of your immune system). After use of these treatments, the patient will receive their own previously collected blood stem cells (autologous stem cell transplant). The ability of these experimental treatments to stop relapses and progression (worsening) of your systemic sclerosis will be assessed.

Arms: arm 1: Hematopoietic Stem Cell Therapy will be performed as follows: Autologous stem cells will be infused after conditioning with rituximab, fludarabine, cyclophosphamide, Mesna, rATG (rabbit), and methylprednisolone. Granulocyte-colony stimulating factor (G-CSF) and intravenous immunoglobulin (IVIg) will be administered post-transplant.
Interventions: intervention 1: Rituximab intervention 2: Fludarabine intervention 3: Cyclophosphamide intervention 4: Mesna intervention 5: rATG intervention 6: Methylprednisolone intervention 7: G-CSF intervention 8: IVIg intervention 9: Autologous Stem Cells
Intervention descriptions: intervention 1: Monoclonal antibody therapy used to treat certain autoimmune diseases and types of cancer intervention 2: A chemotherapy medication commonly used in the treatment of leukemia and lymphoma intervention 3: A medication used as chemotherapy and to suppress the immune system intervention 4: A medication used in those taking cyclophosphamide or ifosfamide to decrease the risk of bleeding from the bladder intervention 5: A rabbit polyclonal antibody to lymphocytes intervention 6: A corticosteroid medication used to suppress the immune system and decrease inflammation intervention 7: A glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream intervention 8: Pooled immunoglobulin (IgG) from thousands of plasma donors that has immunomodulatory and anti-inflammatory effects intervention 9: Infusion of patient's own stem cells

Protocol documents:
Prot_002.pdf: 





































































































SAP_000.pdf:
Clinical trial NCT03592121
Conditions: Sexual Dysfunction Sexual Arousal Disorder Sexual Dysfunction, Physiological Breast Cancer Nipple Disorder Neuropathy Cancer of Breast
Keywords: Nipple Neuropathy, Cancer Survivor
Sponsor: Applied Biology, Inc.
Start date: 2018-07-09; Completion date: 2019-10-12
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to investigate the possibility that a topical drug could restore nipple sensitivity and improve sexual quality of life in breast cancer survivors.

Detailed description:
Approximately, 80% of breast cancer survivors undergoing will suffer from a permanent reduced reduction in nipple sensitivity and associated lowerdecrease in sexual quality of life. Currently, there are no treatments for restoring nipple sensitivity and the associatedto improve lower sexual quality of life this condition. It would thus be of great clinical benefit to post breast surgery patients if a provide a new safe and , effective , topical , on-demand, treatment for this condition can be developed.

Arms: arm 1: Apply to both nipple/areola regions approximately 1 hour prior to sexual activity arm 2: Apply to both nipple/areola regions approximately 1 hour prior to sexual activity
Interventions: intervention 1: AB-101 intervention 2: Placebo
Intervention descriptions: intervention 1: Apply approximately 1 hour prior to sexual activity intervention 2: Apply approximately 1 hour prior to sexual activity

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT02990325
Conditions: HIV Infections Health Volunteers
Keywords: ABX464, HIV infection
Sponsor: Abivax S.A.
Start date: 2017-03-27; Completion date: 2019-10-21
Enrollment: 36 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the ABX464-005 study is to characterize the systemic and mucosal immunological sequelae associated with exposure to ABX464 and to explore selected immunological endpoints, compartmental pharmacokinetics, and pharmacodynamics.

Detailed description:
The purpose of the ABX464-005 study is to characterize the systemic and mucosal immunological sequelae associated with exposure to ABX464 and to explore selected immunological endpoints, compartmental pharmacokinetics, and pharmacodynamics. The site will screen and enroll 12 HIV-infected subjects who will receive 150 mg ABX464 orally once daily for 28 days (Cohort 1). Following completion of this cohort a further 24 subjects will be enrolled: 12 HIV-uninfected subjects will receive 50 mg ABX464 orally once daily for 28 days (Cohort 2) and 12 HIV-infected subjects (Cohort 3) who will 50 mg ABX464 orally once daily for 84 days.

Arms: arm 1: ABX464, 50mg per Capsule Three Capsules per day for 28 days arm 2: ABX464, 50mg per Capsule One Capsule per day for 28 days arm 3: ABX464, 50mg per Capsule One Capsule per day for 84 days
Interventions: intervention 1: ABX464 150mg intervention 2: ABX464 50mg intervention 3: ABX464 50mg
Intervention descriptions: intervention 1: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects) intervention 2: ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects) intervention 3: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)

Protocol documents:
Prot_000.pdf: 

































































































SAP_001.pdf:
Clinical trial NCT00008385
Conditions: Lung Cancer
Keywords: stage I non-small cell lung cancer
Sponsor: ECOG-ACRIN Cancer Research Group
Start date: 2000-12-18; Completion date: 2019-11-01
Enrollment: 1772 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. It is not yet known if selenium is effective in preventing the growth of new tumors in patients with previously resected non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying selenium to see how well it works compared to a placebo in preventing the development of second primary lung tumors in patients who have undergone surgery to remove stage I non-small cell lung cancer.

Detailed description:
OBJECTIVES:

Primary Objective:

* Determine the efficacy of selenium in terms of reducing the incidence of second primary lung tumors in participants with previously resected stage I non-small cell lung cancer.

Secondary Objectives:

* Evaluate the qualitative and quantitative toxicity of selenium in these patients.
* Compare the incidence of specific cancers, mortality from cancer, and overall survival of participants treated with selenium vs those treated with placebo.

OUTLINE: This is a randomized, double-blinded, placebo-controlled, multicenter study. Participants are stratified according to smoking status (actively smoking or stopped less than 1 year ago vs. stopped at least 1 year ago vs. never smoked or no more than 100 cigarettes ever), gender, and stage and previous therapy (stage IA vs. stage IB with previous therapy vs. stage IB with no previous therapy). Participants are randomized in a 1:2 ratio to arm I and arm II.

* Arm I: Participants receive an oral yeast placebo as in arm II.
* Arm II: Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.

Participants are followed annually (every 12 months) for 10 years.

PROJECTED ACCRUAL: A total of 1,960 participants will be accrued for this study within 4 years.

Arms: arm 1: Participants receive an oral yeast placebo as in arm II. arm 2: Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.
Interventions: intervention 1: placebo intervention 2: selenium
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally

Protocol documents: