ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02338960
Conditions: Hypoactive Sexual Desire Disorder
Keywords: HSDD Female Sexual Desire Disorder decreased desire female sexual dysfunction
Sponsor: Palatin Technologies, Inc
Start date: 2015-01-01; Completion date: 2017-06-29
Enrollment: 714 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an optional Open-label Extension to evaluate the efficacy of bremelanotide (BMT), administered subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without decreased arousal) in premenopausal females.

Detailed description:
This will be a multicenter, randomized, placebo-controlled, parallel group study in up to 80 sites in the United States of America (USA) and Canada to evaluate the efficacy and safety of a fixed dose of SC BMT versus placebo on an as-needed basis under conditions of home use in premenopausal women with HSDD (with or without decreased arousal).

The study will consist of 2 phases: (1) Core Study: 4-week no-treatment qualification period, a 4-week single-blind placebo treatment period (baseline), and a 24-week double-blind treatment period where participants will self-administer placebo or BMT 1.75 mg SC via an autoinjector; and (2) Extension Phase: a 52-week open-label treatment period during which all subjects will receive BMT 1.75 mg.

Primary Objective

• To evaluate the efficacy of bremelanotide (BMT), administered subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without decreased arousal) in premenopausal females.

Secondary Objectives

* To evaluate the efficacy of BMT in premenopausal women in the double-blind Core Study, as assessed by subject responses to questionnaires measuring sexual function, treatment satisfaction, and distress associated with sexual dysfunction.
* To evaluate the safety of BMT in premenopausal women in the double-blind Core Study.
* To evaluate the safety of long-term therapy with BMT in the open label Extension Phase.
* To evaluate the efficacy of long-term therapy with BMT in the open-label Extension Phase.

Arms: arm 1: (Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks

(OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks arm 2: (Main Study) PBO administered SC on an as-desired basis for 24 weeks

(OLE Study) subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks
Interventions: intervention 1: Bremelanotide intervention 2: Placebo
Intervention descriptions: intervention 1: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone) intervention 2: Placebo

Protocol documents:
Clinical trial NCT02636907
Conditions: Arthritis, Rheumatoid
Sponsor: Boehringer Ingelheim
Start date: 2016-01-06; Completion date: 2017-06-29
Enrollment: 77 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, phase II study of BI 695501 to assess handling experience of patients with Rheumatoid Arthritis using an autoinjector. The extension phase is to provide patients with additional exposure to BI 695501 and to enhance the safety database for this compound.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: BI 695501 Autoinjector intervention 2: BI 695501 Prefilled syringe
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00100802
Conditions: Anaplastic Astrocytoma Central Nervous System Neoplasm Glioblastoma Gliosarcoma Spinal Cord Neoplasm
Sponsor: Children's Oncology Group
Start date: 2005-03-21; Completion date: 2017-06-30
Enrollment: 118 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well giving radiation therapy together with temozolomide and lomustine works in treating young patients with newly diagnosed gliomas. Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide and lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide and lomustine after surgery may kill any remaining tumor cells.

Detailed description:
PRIMARY OBJECTIVES:

I. Compare event-free survival of pediatric patients with newly diagnosed high-grade gliomas treated with adjuvant radiotherapy and temozolomide followed by temozolomide and lomustine with historical controls.

II. Determine the toxicity of this regimen in these patients. III. Correlate MGMT and p53 expression in tumor tissue with outcome in patients treated with this regimen.

IV. Correlate polymorphisms in GSTP1, GSTM1 and GSTT1 genes and GSTP1 protein expression in tumors with survival in patients treated with this regimen.

OUTLINE: This is a pilot, multicenter study.

CHEMORADIOTHERAPY: Patients receive oral temozolomide once daily on days 1-42. Patients also undergo concurrent radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33 and 36-40. Patients who did not undergo prior gross total resection also undergo boost radiotherapy once daily on days 43-47.

MAINTENANCE CHEMOTHERAPY: Four weeks after completion of chemoradiotherapy, patients receive oral temozolomide once daily on days 1-5 and oral lomustine on day 1. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year, every 6 months for 3 years and then annually thereafter.

Arms: arm 1: Patients receive oral temozolomide once daily on days 1-42. Patients also undergo concurrent radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33 and 36-40. Patients who did not undergo prior gross total resection also undergo boost radiotherapy once daily on days 43-47. Four weeks after completion of chemoradiotherapy, patients receive oral temozolomide once daily on days 1-5 and oral lomustine on day 1. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Laboratory Biomarker Analysis intervention 2: Lomustine intervention 3: Radiation Therapy intervention 4: Temozolomide
Intervention descriptions: intervention 1: Correlative studies intervention 2: Given PO intervention 3: Undergo radiation therapy intervention 4: Given PO

Protocol documents:
Clinical trial NCT02333071
Conditions: Hypoactive Sexual Desire Disorder
Keywords: HSDD Female Sexual Desire Disorder
Sponsor: Palatin Technologies, Inc
Start date: 2014-12-01; Completion date: 2017-06-30
Enrollment: 723 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an optional Open-label Extension to evaluate the efficacy of bremelanotide (BMT), administered subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without decreased arousal) in premenopausal females.

Detailed description:
This will be a multicenter, randomized, placebo-controlled, parallel group study in up to 80 sites in the United States of America (USA) and Canada to evaluate the efficacy and safety of a fixed dose of SC BMT versus placebo on an as-needed basis under conditions of home use in premenopausal women with HSDD (with or without decreased arousal).

The study will consist of 2 phases: (1) Core Study: 4-week no-treatment qualification period, a 4-week single-blind placebo treatment period (baseline), and a 24-week double-blind treatment period where participants will self-administer placebo or BMT 1.75 mg SC via an autoinjector; and (2) Extension Phase: a 52-week open-label treatment period during which all subjects will receive BMT 1.75 mg.

Primary Objective

• To evaluate the efficacy of bremelanotide (BMT), administered subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without decreased arousal) in premenopausal females.

Secondary Objectives

* To evaluate the efficacy of BMT in premenopausal women in the double-blind Core Study, as assessed by subject responses to questionnaires measuring sexual function, treatment satisfaction, and distress associated with sexual dysfunction.
* To evaluate the safety of BMT in premenopausal women in the double-blind Core Study.
* To evaluate the safety of long-term therapy with BMT in the open label Extension Phase.
* To evaluate the efficacy of long-term therapy with BMT in the open-label Extension Phase.

Arms: arm 1: (Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks

(OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks arm 2: (Main Study) PBO administered SC on an as-desired basis for 24 weeks

(OLE Study) subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks
Interventions: intervention 1: Bremelanotide intervention 2: Placebo
Intervention descriptions: intervention 1: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone) intervention 2: Placebo

Protocol documents:
Clinical trial NCT02837237
Conditions: Chronic Kidney Disease
Sponsor: KBP Biosciences
Start date: 2016-07-13; Completion date: 2017-06-30
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study explores the use of KBP-5074 in patients with advanced stages of Chronic Kidney Disease (CKD) (including patients with severe renal impairment and those on hemodialysis \[HD\]) and to assess the safety, tolerability, and pharmacokinetics (PK) of single doses of KBP-5074 in male and female patients with severe CKD (defined as estimated glomerular filtration rate \[eGFR\] ≥15 mL/min/1.73 m2 and ≤29 mL/min/1.73 m2, based on the Modification of Diet in Renal Disease \[MDRD\] equation) and a subset of patients requiring HD.

Detailed description:
This is a Phase 1, multicenter, open-label, 2-part study designed to assess the PK, safety, and tolerability of KBP-5074 in patients undergoing HD and non-HD patients with severe CKD (defined using the eGFR ≥15 mL/min/1.73 m2 and ≤29 mL/min/1.73 m2 based on the MDRD equation). The study will be conducted at up to 4 clinical research units (CRUs) in the US. Approximately 12 patients will be enrolled in the study (a single cohort of 6 patients in each of Part 1 and Part 2). Parts 1 and 2 of the study will be conducted in parallel. If Part 1 is completed prior to the completion of Part 2, or vice versa, the PK, safety, and tolerability analyses for the completed study part may proceed as planned and will not be delayed based on the timing of the other respective study part.

Arms: arm 1: Single oral dose
Interventions: intervention 1: KBP-5074
Intervention descriptions: intervention 1: In Part 1 of the study, non-HD patients with severe CKD in Cohort 1 will receive a single oral capsule dose of KBP-5074 on Day 1 following a fast between 2 and 4 hours.

In Part 2 of the study, HD patients with severe CKD will receive a single oral capsule dose of KBP-5074 following a fast between 2 and 4 hours. The dose of KBP 5074 will be administered on Day 1 immediately following a dialysis session.

Protocol documents:
Clinical trial NCT01234402
Conditions: Breast Cancer
Keywords: Breast Cancer
Sponsor: Eli Lilly and Company
Start date: 2011-03-01; Completion date: 2017-07-01
Enrollment: 153 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
An open-label, multicenter, randomized, Phase 2 trial in which participant with unresectable, locally advanced or metastatic breast cancer who have been previously treated with anthracycline and taxane therapy receive ramucirumab DP or Icrucumab (IMC-18F1) administered on an every-21-day cycle (in combination with oral capecitabine therapy; capecitabine is administered twice a day on Days 1-14 of each cycle). Approximately 150 participants will be randomized in a 1:1:1 ratio to either ramucirumab DP or Icrucumab (IMC-18F1) in combination with capecitabine (Arm A and Arm B, respectively) or capecitabine monotherapy (Arm C). Randomization will be stratified by triple-negative receptor status (estrogen receptor-negative, progesterone receptor-negative, and human epidermal growth factor receptor-2 \[HER2/neu\]-negative) (yes/no) and receipt of prior antiangiogenic therapy.

Treatment with the study medication(s) will continue until disease progression, the development of unacceptable toxicity, noncompliance or withdrawal of consent by the participant, or investigator decision. Capecitabine dose reductions in the setting of significant myelosuppression, hand-and-foot syndrome, or diarrhea will be required.

Detailed description:

Arms: arm 1: Cycles repeat until disease progression, the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant. arm 2: Cycles repeat until disease progression, the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant. arm 3: Crossover Study:

\* At the discretion of the investigator, participants will be eligible to receive either ramucirumab DP or Icrucumab (IMC-18F1) in combination with capecitabine, after radiographic disease progression while on capecitabine. The investigator will decide which investigational product will be given.

Cycles repeat every 21 days until disease progression, the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant.
Interventions: intervention 1: Ramucirumab DP intervention 2: IMC-18F1 intervention 3: Capecitabine
Intervention descriptions: intervention 1: 10 mg/kg I.V.

Day 1 of every-21-day cycle intervention 2: 12 mg/kg I.V.

Days 1 and 8 of every-21-day cycle intervention 3: 1000 mg/m\^2 orally

Twice a day for 14 days

Protocol documents:
Clinical trial NCT01221753
Conditions: Squamous Cell Carcinoma of the Head and Neck Human Papilloma Virus
Keywords: SSCHN HPV IMRT
Sponsor: Dana-Farber Cancer Institute
Start date: 2011-07-01; Completion date: 2017-07-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In this research study, the investigators are studying whether a reduced dose of radiation when given with standard doses of chemotherapy can reduce side effects without compromising control of the cancer. An approved treatment for squamous cell carcinoma of the head and neck is initial chemotherapy followed by radiation and chemotherapy together. This treatment is effective but has many immediate and long-term side effects. People who have squamous cell carcinoma of the head and neck (SSCHN) that is related to an infection by the human papillomavirus (HPV) have been shown to have a high response to this treatment along with a high cure rate. The investigators think that by reducing the intensity of this treatment, they may be able to reduce immediate and long-term side effects which may lead to long term improvements in quality of life and function.

Detailed description:
OBJECTIVES:

Primary

To determine rate of local-regional control at 2 years

Secondary

To determine Progression Free Survival at 2 and 5 years

To determine Overall Survival at 2 and 5 years

To assess acute toxicity and long term toxicity of reduced radiation dose at 2 and 5 years

Arms: arm 1: Patients received 3 cycles (21 days each) of TPF induction chemotherapy: docetaxel 75 mg/m2 IV day 1; cisplatin 100 mg/m2 IV day 1 (carboplatin substitute permitted); 5-FU 1000 mg/m2/day IV pump continuous days 1-4. Concurrent chemoradiotherapy followed 4-6 weeks after day 1 of cycle 3 TPF induction: cetuximab 400 mg/m2 IV loading dose 1 week prior and 250 mg/m2 IV weekly (panitumumab substitute permitted); carboplatin AUC 1.5 (Calvert formula) IV weekly; Intensity modulated radiation therapy (IMRT)-response based dosing for 6-7 weeks.
Interventions: intervention 1: docetaxel intervention 2: cisplatin intervention 3: 5-FU intervention 4: IMRT intervention 5: cetuximab intervention 6: carboplatin
Intervention descriptions: intervention 1: None intervention 2: Given intravenously on day 1 of each cycle intervention 3: None intervention 4: None intervention 5: None intervention 6: None

Protocol documents:
Clinical trial NCT01355705
Conditions: Multiple Myeloma
Sponsor: Michaela Liedtke
Start date: 2011-08-01; Completion date: 2017-07-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To assess if amrubicin is safe and useful for patients with multiple myeloma requiring additional treatment.

Detailed description:
PRIMARY OBJECTIVES

* Establish the maximum tolerated dose (MTD) and toxicity profile for the combination of amrubicin with lenalidomide and dexamethasone in previously treated adult patients with multiple myeloma during Phase I
* Determine the combined rate of complete response (CR) and very good partial response (VGPR) for this combination in this population as defined by the International Myeloma Working Group Uniform Response Criteria (IMWGURC)

SECONDARY OBJECTIVES

* Determine the overall response rate (CR, VGPR and PR)
* Assess additional evidence of ant-tumor activity as measured by duration of response (DOR), progression-free survival (PFS), time to tumor progression (TTP), and overall survival (OS)

Arms: arm 1: Amrubicin will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.

Concurrent therapeutic medications:

* Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14
* Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)

Other drugs:

* Aspirin: 81 or 325 mg daily oral
* Pegfilgrastim subcutaneous on Day 2
Interventions: intervention 1: Amrubicin intervention 2: Lenalidomide intervention 3: Dexamethasone intervention 4: Aspirin intervention 5: Pegfilgrastim
Intervention descriptions: intervention 1: 40, 60, or 80 mg/m2 intravenous (IV) intervention 2: 15 mg daily by mouth intervention 3: 40 mg weekly by mouth intervention 4: 81 or 325 mg daily by mouth intervention 5: 6 mg subcutaneous on Day 2

Protocol documents:
Clinical trial NCT01395316
Conditions: Multiple Sclerosis
Sponsor: University of Chicago
Start date: 2011-06-01; Completion date: 2017-07-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The MRI study is designed to identify possible mechanisms by which alemtuzumab acts to protect the brain from inflammation and how it may enhance repair through remyelination.

Detailed description:
To identify specific changes in T cell subsets and functions in Relapsing Remitting Multiple Sclerosis.

Arms: arm 1: Single arm, single cohort study, all subjects will be dosed with alemtuzumab.
Interventions: intervention 1: Alemtuzumab
Intervention descriptions: intervention 1: 10 mg/ml alemtuzumab intravenous infusion, sterile clear, colorless solution. dosage: 2 cycles. Month 0 dosed over 5 consecutive days: month 12 dosed over 3 consecutive days.

Protocol documents:
Clinical trial NCT01497860
Conditions: Low-grade Glioma
Keywords: pediatric children glioma low-grade vinorelbine recurrent progressive
Sponsor: Eugene Hwang
Start date: 2011-07-01; Completion date: 2017-07-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate whether weekly Vinorelbine treatment can shrink or slow the growth of pediatric low-grade gliomas that have either returned or are continuing to grow.

Vinorelbine is a semi-synthetic vinca alkaloid that has recently generated interest in patients with pediatric low-grade glioma. It has been specifically synthesized to broaden its therapeutic spectrum and decrease the neurotoxicity associated with related agents.

Detailed description:
Different treatments exist for children with progressive or recurrent low-grade glioma. Each has variable efficacy at slowing or reversing growth, and exploration continues into finding better-tolerated, more effective treatments.

Vinorelbine has recently generated interest in stabilizing some pediatric low-grade gliomas. It has been fairly well tolerated in both adult and pediatric studies that have examined its use in other tumors.

Objective: To test the efficacy of Vinorelbine in children with pediatric low-grade glioma that has returned or continues to grow.

In this trial, Vinorelbine will be given intravenously once a week for 6 weeks followed by a 2 week rest (6 of every 8 weeks) for one year. The patients will then be followed for 60 months. Progression free survival is the primary outcome and defined as the none of the following: greater a 20% increase in the sun of the longest diameter of the target lesion, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Arms: arm 1: IV Vinorelbine (6mg/m2) provided once a week for 6 weeks followed by a 2 week rest (6 of every 8 weeks) for one year. Progression free survival will be monitored for 60 months.
Interventions: intervention 1: Vinorelbine
Intervention descriptions: intervention 1: IV Vinorelbine (6mg/m2) provided once a week for 6 weeks followed by a 2 week rest (6 of every 8 weeks) for one year. Progression free survival will be monitored for 60 months.

Protocol documents:
Clinical trial NCT01720043
Conditions: Multiple Myeloma
Keywords: multiple myeloma
Sponsor: University of Utah
Start date: 2013-07-01; Completion date: 2017-07-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the effect of VELCADE on platelet aggregation at baseline, 24 hours and 48 hours after infusion in patients with multiple myeloma

Detailed description:

Arms: arm 1: All participants enrolled
Interventions: intervention 1: Velcade
Intervention descriptions: intervention 1: Single dose of Velcade (1.0-1.3 mg/m2 dose)

Protocol documents: