ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02117479
Conditions: Pancreatic Cancer
Keywords: Metastatic pancreatic cancer Metastatic pancreatic adenocarcinoma that is recurrent
Sponsor: Incyte Corporation
Start date: 2014-03-01; Completion date: 2016-12-01
Enrollment: 321 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Determining the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of advanced or metastatic pancreatic cancer.

Detailed description:
This was a randomized, double-blinded, placebo-controlled, Phase 3 study, in which approximately 310 participants with advanced or metastatic adenocarcinoma of the pancreas who have failed, or were intolerant to first-line chemotherapy, were to be randomized (1:1) to one of the following treatment groups:

* Treatment A (N = 155): Capecitabine + ruxolitinib
* Treatment B (N = 155): Capecitabine + placebo

Treatment consisted of repeating 21-day cycles. Capecitabine was self-administered for the first 14 days of each cycle, and ruxolitinib/placebo was self-administered daily for each cycle. Treatment for all participants continued as long as the regimen was tolerated, and the participant did not meet discontinuation criteria. Participants who discontinued study treatment before study termination were monitored for safety up to 30-35 days from the end of treatment. All participants were followed for survival until study termination or the safety follow-up visit.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ruxolitinib intervention 2: Placebo intervention 3: Capecitabine
Intervention descriptions: intervention 1: 5 mg tablets to be administered by mouth twice daily (BID) intervention 2: 5 mg tablets to be administered by mouth twice daily (BID) intervention 3: 150 and 500 mg tablets to be administered by mouth twice daily (BID)

Protocol documents:
Clinical trial NCT02476617
Conditions: Chronic Hepatitis C Hepatitis C (HCV) Hepatitis C Genotype 1a
Keywords: Treatment naive Interferon free HCV Chronic Hepatitis C Hepatitis C Genotype 1a Hepatitis C pegylated-interferon (pegIFN)/ribavirin (RBV) experienced
Sponsor: AbbVie
Start date: 2015-06-01; Completion date: 2016-12-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A study to evaluate immune restoration following removal of viral antigen in non-cirrhotic hepatitis C virus (HCV) genotype (GT) 1a treatment-naïve and pegylated-interferon (pegIFN)/ribavirin (RBV) treatment-experienced adults receiving treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir coadministered with ribavirin (RBV) for 12 weeks.

Detailed description:
A study to evaluate the role of ombitasvir/paritaprevir/ritonavir and dasabuvir coadministered with RBV treatment leading to sustained virologic response 12 weeks post-dosing (SVR12) on the changes from baseline in IFN-stimulated gene (ISG) expression in peripheral blood mononucleated cells (PBMCs) in HCV GT 1a-infected adult participants.

Arms: arm 1: Ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily \[QD\]) + dasabuvir (250 mg twice daily \[BID\]) + weight based Ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided BID)
Interventions: intervention 1: ombitasvir/paritaprevir/ritonavir intervention 2: dasabuvir intervention 3: ribavirin
Intervention descriptions: intervention 1: ombitasvir/ABT-450/ritonavir tablets intervention 2: dasabuvir tablets intervention 3: ribavirin tablets

Protocol documents:
Clinical trial NCT00077064
Conditions: Lung Cancer Pulmonary Complications Radiation Fibrosis
Keywords: radiation fibrosis pulmonary complications limited stage small cell lung cancer stage II non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer stage I non-small cell lung cancer
Sponsor: Radiation Therapy Oncology Group
Start date: 2003-06-01; Completion date: 2016-12-01
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Captopril is a drug that may be able to decrease side effects caused by radiation therapy, and may improve the quality of life of patients with non-small cell lung cancer or limited-stage small cell lung cancer.

PURPOSE: This randomized phase II trial is studying how well captopril works in decreasing side effects and improving the quality of life in patients who have received radiation therapy with or without chemotherapy for stage I, stage II, or stage IIIB non-small cell lung cancer or limited-stage small cell lung cancer.

Detailed description:
OBJECTIVES:

* Determine the effect of captopril on the incidence of pulmonary damage at 12 months after radiotherapy with or without chemotherapy in patients with stage II-IIIB non-small cell lung cancer, stage I central non-small cell lung cancer, or limited stage small cell lung cancer.
* Compare the quality of life of patients treated with captopril vs patients who undergo post-radiotherapy observation only.
* Determine the persistence of captopril's effect on pulmonary toxicity in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, total lung irradiated (\< 25% vs 25-37% vs more than 37%), prior surgery (yes vs no), and prior chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral captopril 3 times daily for 1 year in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients undergo observation only for 1 year. Quality of life is assessed at baseline and at months 3, 6, 12, and 18.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 205 patients will be accrued for this study within 18 months.

Arms: arm 1: Clinical observation arm 2: Captopril
Interventions: intervention 1: captopril
Intervention descriptions: intervention 1: Captopril 12.5 mg t.i.d. for first two weeks, increased to 25 mg t.i.d. for the second two weeks of therapy. Thereafter, the dose will be increased to 50 mg t.i.d. for the remainder of the one-year of therapy (52 total weeks of drug administration).

Protocol documents:
Clinical trial NCT00130117
Conditions: Amenorrhea
Keywords: leptin hypothalamic amenorrhea exercise-induced amenorrhea neuroendocrine function bone metabolism
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2010-04-01; Completion date: 2016-12-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether administration of an investigational medication called leptin (r-metHuLeptin) in replacement doses can improve bone health, reproductive function, hormone levels, immune function, and overall sense of well-being in women with hypothalamic (exercise-induced) amenorrhea (HA) who are being treated with oral contraceptive pills (OCPs), compared to placebo. Women with hypothalamic amenorrhea have low leptin levels. This study is based on the hypothesis that the relative leptin deficiency in women with hypothalamic (exercise-induced) amenorrhea may be the reason for the lack of menstrual cycles, hormone abnormalities, and bone loss associated with this condition.

Detailed description:
Leptin is a hormone secreted by fat cells under normal conditions and acts in the brain to regulate energy usage and hormone levels. Women with HA who do not have regular periods have low leptin levels and may also have other hormone abnormalities as well as loss of bone density (osteopenia or osteoporosis). This study will evaluate how leptin (a fat cell hormone that normally circulates in the blood) affects bone density, menstrual periods, hormone levels, bone metabolism (how bone forms and turns over), immune function (how well the body can fight infection), metabolic rate (how many calories are used at rest), and overall sense of well-being and appetite in women with HA (i.e. no regular menstrual periods due to low levels of pituitary hormones that regulate estrogen production from the ovary). It will also investigate whether leptin replacement can be used as an adjunct to the current standard of care for HA patients, i.e. OCPs.

Part A is a Randomized, placebo-controlled 36-week study. Part B is an Optional open-label 52-week study. There will also be an optional Reward Sub-study, including healthy controls, designed to investigate leptin's relation to reward processing by collecting participants' brain and behavioral responses to images (e.g., pictures of food vs. non-food). Brain responses will be collected and will also be assessed via functional Magnetic Resonance Imaging (fMRI).

Comparison: Part A = leptin-treated group to placebo-treated group and Part B optional sub study = leptin-treated group to health controls

Arms: arm 1: r-metHuLeptin administered subcutaneously. arm 2: PLACEBO
Interventions: intervention 1: r-metHuLeptin intervention 2: Oral Contraceptive Pills (OCPs) intervention 3: Placebo
Intervention descriptions: intervention 1: Starting dose: 0.08mg/kg once daily Subcutaneous injection. intervention 2: Sprintec taken orally once daily. intervention 3: placebo (no active medication)

Protocol documents:
Clinical trial NCT00140205
Conditions: Energy Deficiency Due to Short-term Fasting
Keywords: leptin fasting pharmacokinetics
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2001-02-01; Completion date: 2016-12-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study will be to determine the correct dose of leptin, a natural hormone secreted by the fat cells, to give to people when they are fasting and also to determine whether giving leptin to a person when he or she is fasting will reverse the changes in hormone levels that occur with fasting.

Detailed description:
Leptin is a newly-identified hormone secreted by fat cells under normal conditions that acts in the brain to decrease appetite and increase long term energy usage. Leptin levels usually go down when people are not eating for extended periods of time. Changes in metabolism and certain hormone levels also occur with fasting. By studying the pharmacokinetics of leptin administration, we can evaluate the changes of leptin levels in response to giving different doses of leptin as well as acute changes of other hormones in response to leptin levels. Investigations such as this one have important implications for the future therapeutic use of leptin, including determining the appropriate dose of leptin to use in future studies involving leptin administration.

Comparison: subjects receiving leptin at 3 different doses in the fed state compared to the fasting state

Arms: arm 1: 1-day fed studies with administration of r-metHuLeptin at three different doses (0.01 mg/kg, 0.1 mg/kg, 0.3 mg/kg). All subjects participated in 3 studies in the fed condition (Part A) and 3 separate 72-hour fasting studies.

Intervention administered was-r-metreleptin in 3 different doses
Interventions: intervention 1: r-metHuLeptin
Intervention descriptions: intervention 1: r-metreleptin was given in 3 different dose in fed and fasting states

Protocol documents:
Clinical trial NCT00140231
Conditions: Fasting
Keywords: leptin fasting reproductive neuroendocrine immune function energy deficiency associated with short-term fasting
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2002-10-01; Completion date: 2016-12-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study will be to determine whether giving leptin (r-metHuLeptin) to a person when he or she is fasting will reverse changes in metabolism, and hormone levels, and immune function associated with fasting, which decreases leptin levels.

Detailed description:
Leptin is a hormone secreted by fat cells under normal conditions and acts in the brain to decrease appetite and increase energy use. Leptin levels usually go down with fasting. This study will evaluate the secretion of an investigational agent called leptin in lean and overweight individuals while fasting and investigate the potential role of leptin as a regulator of immune function and mediator of the neuroendocrine response to food deprivation in humans. Data derived from these studies will provide insights into the mechanisms underlying altered hormone levels and immune function in malnutrition and obesity and thus may provide the basis for future therapeutic interventions for obesity.

Comparison: fed state vs. fasting state vs. fasting + leptin state

Arms: arm 1: r-metHuLeptin self-administered subcutaneously arm 2: Placebo, administered in same method as active arm.
Interventions: intervention 1: r-metHuLeptin intervention 2: placebo
Intervention descriptions: intervention 1: recombinant human leptin intervention 2: placebo (no active drug)

Protocol documents:
Clinical trial NCT00227019
Conditions: Non-small Cell Lung Cancer (NSCLC) Lung Cancer Neoplasm Metastasis
Sponsor: Heather Wakelee
Start date: 2006-03-01; Completion date: 2016-12-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This trial evaluated the safety of combining bevacizumab and pemetrexed in non-small cell lung cancer (NSCLC) patients with stable brain metastases as second-line chemotherapy, while evaluating progression-free survival (PFS) and overall survival (OS).

Detailed description:
Brain metastases are a common complication of advanced non-small-cell lung cancer (NSCLC) both at initial presentation and at the time of disease progression. Patients with brain metastases have often been excluded from large randomized phase III trials due to concerns of poorer survival and impaired ability of drugs to cross the blood-brain barrier. However, as survival has improved, some trials have included such patients, often finding similar benefit to patients with metastatic disease elsewhere.

Bevacizumab is a recombinant, humanized monoclonal antibody against vascular endothelial growth factor, has emerged as an important adjunct to platinum-based chemotherapy doublets for use in advanced NSCLC. This drug is normally used as a first line chemotherapy. Pemetrexed is a multi-targeted anti-folate agent,which is approved for use in first-line (with platinum), maintenance, and second-line treatment of advanced nonsquamous NSCLC. Based on the efficacy of pemetrexed as a second line agent and the safety questions surrounding bevacizumab in those with treated brain metastases, a trial was designed to look at the combination of both agents as a second line therapy in NSCLC patients with treated stable brain metastases

Arms: arm 1: pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV). In addition to Vitamin B12 + Folate + Dexamethasone
Interventions: intervention 1: Bevacizumab intervention 2: Pemetrexed intervention 3: Vitamin B12 intervention 4: Folate intervention 5: Dexamethasone
Intervention descriptions: intervention 1: 15 mg/kg, IV over 10 minutes every 3 weeks intervention 2: 500 mg/m²; IV over 10 minutes every 3 weeks intervention 3: 1000 micrograms, IM injection 1-2 weeks prior to treatment and repeated every 9 weeks until last dose of pemetrexed intervention 4: 350 to 1000 micrograms 1 week prior to treatment and 3 weeks after last pemetrexed dose intervention 5: 4 mg; oral, twice a day at the following times: the day before, of and after each dose of pemetrexed

Protocol documents:
Clinical trial NCT00278109
Conditions: Breast Cancer
Keywords: stage I breast cancer stage II breast cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2004-07-01; Completion date: 2016-12-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide and doxorubicin, 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 cyclophosphamide and doxorubicin after surgery may kill any tumor cells that remain.

PURPOSE: This phase I/II trial is studying the side effects of radiation therapy when given together with cyclophosphamide and doxorubicin and to see how well they work in treating women with stage I or stage II breast cancer who have undergone surgery.

Detailed description:
OBJECTIVES:

* Assess the potential acute and late skin and subcutaneous toxicities in women with resected stage I or II breast cancer treated with partial breast irradiation (PBI) and concurrent cyclophosphamide/doxorubicin (AC) chemotherapy.
* Assess the cosmetic effects of partial breast irradiation/chemotherapy (PBIC) in these patients.
* Assess the local control rate in patients treated with this regimen.

OUTLINE: Patients undergo partial breast radiotherapy once daily, 5 days a week, for 3 weeks. Patients also receive doxorubicin IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment with doxorubicin and cyclophosphamide repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for approximately 10 years.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Arms: arm 1: Phase I Single Arm study of PBI with concurrent chemotherapy. Primary endpoint is radiation toxicity. The intervention is partial breast radiation with doxorubicin and cyclophosphamide.
Interventions: intervention 1: cyclophosphamide intervention 2: Doxorubicin intervention 3: radiation
Intervention descriptions: intervention 1: chemotherapy intervention 2: doxorubicin intervention 3: radiation

Protocol documents:
Clinical trial NCT00331760
Conditions: Cervical Cancer Endometrial Cancer
Keywords: stage I endometrial carcinoma stage II endometrial carcinoma stage III endometrial carcinoma endometrial adenoacanthoma endometrial adenocarcinoma endometrial adenosquamous cell carcinoma stage IB cervical cancer stage IIA cervical cancer stage IIB cervical cancer cervical adenocarcinoma cervical adenosquamous cell carcinoma cervical squamous cell carcinoma
Sponsor: Radiation Therapy Oncology Group
Start date: 2006-03-01; Completion date: 2016-12-01
Enrollment: 106 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Specialized radiation therapy (RT), such as intensity-modulated radiation therapy (IMRT), that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving intensity-modulated radiation therapy to the pelvis with or without chemotherapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well intensity-modulated radiation therapy to the pelvis with or without chemotherapy works in treating patients with endometrial cancer or cervical cancer that has been removed by surgery.

Detailed description:
OBJECTIVES:

* Determine the transportability of intensity modulated radiotherapy (IMRT) to a multi-institutional setting in patients with resected endometrial or cervical cancer.
* Compare the efficacy, in terms of reducing short-term bowel injury, of IMRT versus standard treatments.
* Assess adverse events related to this regimen.
* Estimate the rates of local-regional control, distant metastasis, and disease-free and overall survival.
* Evaluate chemotherapy compliance with this regimen for patients with cervical carcinoma.

OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (cervical vs endometrial cancer).

All patients undergo intensity modulated radiotherapy (IMRT) once a day, 5 days a week, for 5.5 weeks. Patients with cervical cancer also receive cisplatin IV over 30-60 minutes on day 1 or 2. Treatment with cisplatin repeats every 7 days for 5 courses (during radiotherapy) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 6 weeks post-IMRT and then every 3 months for 2 years, every 6 months for years 3-5, and then annually for at least 3 years.

PROJECTED ACCRUAL: A total of 92 patients will be accrued for this study.

Arms: arm 1: Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT) 28 fractions over 5.5 weeks. arm 2: Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) 28 fractions over 5.5 weeks and concurrent weekly cisplatin 40 mg/m\^2 for five weeks.
Interventions: intervention 1: cisplatin intervention 2: intensity-modulated radiation therapy
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00465595
Conditions: Depressive Symptoms Anxiety Cancer
Sponsor: Johns Hopkins University
Start date: 2007-04-01; Completion date: 2016-12-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This research is being done to study the psychological effects of psilocybin in cancer patients. Psilocybin is a naturally occurring substance found in some mushrooms that some cultures have used for centuries in religious practices.

Detailed description:
This research is being done to study the psychological effects of psilocybin in cancer patients. Psilocybin is a naturally occurring substance found in some mushrooms that some cultures have used for centuries in religious practices. Psilocybin has not been approved for general medical use by the U.S. Food and Drug Administration (FDA). Its use in this study is investigational. Psilocybin is a mood-altering drug with effects similar to other hallucinogens like LSD and mescaline. Mescaline is the main psychoactive component of the peyote cactus used in Native American religious practices. Such substances have been used for centuries in some cultures as a way of inducing non-ordinary states of consciousness for religious and spiritual purposes.

An earlier study that was done in our lab with healthy participants found that psilocybin, given in a comfortable and supportive setting, can provide an experience that is personally and spiritually meaningful for the participant. This study is being done to find out if psilocybin can also produce personally and spiritually meaningful experiences in cancer patients. This could be important because spirituality has been associated with increased psychological coping and decreased depression in serious illness. People with a diagnosis of cancer between the ages of 21 and 80 years old and who meet the medical requirements may join. About 44 people are expected to take part in this study.

Arms: arm 1: The Low-Dose-1st Group received the low dose of psilocybin on the first session and the high dose on the second session arm 2: The High-Dose-1st Group received the high dose of psilocybin on the first session and the low dose on the second session
Interventions: intervention 1: psilocybin
Intervention descriptions: intervention 1: The dose of psilocybin received in the two sessions will range anywhere from low to high.

Protocol documents: