Kornimate/medical-research-clean huggingface dataset:
the science of the art of palliative care

Conditions: Gastrointestinal Cancer; Lung Cancer; Advanced Cancer

Summary: this feasibility pilot study is designed to learn whether patients and their care partners (e.g., family members) are willing and able to complete two study visits at dartmouth college while receiving cancer care at dartmouth-hitchcock medical center.

a feasibility pilot open label, single-arm observational case series of 10 patients with metastatic gastrointestinal and lung cancer patients and 10 care partners. participants will complete two study visits, separated by approximately 8-16 weeks of usual oncologic care with early integrated specialty palliative care. the palliative care physician will also be a study participant. primary objective: to develop and refine study procedures which can be used in future research in order to further understanding of the mechanisms of action of specialty palliative. expected products: manual of operating procedures and web-based data collection forms. secondary objectives: to test the feasibility of conducting a mechanism-focused clinical trial of primary palliative care vs. specialty palliative care for advanced cancer patients and their care partners. expected products: preliminary data demonstrating the feasibility of study procedures sufficient to prove this study design is possible.

Eligibility criteria:
inclusion criteria: * 18 years or older * patient: has received a diagnosis of advanced lung or gastrointestinal cancer within the last 24 weeks (note: advanced gi cancer will likely be pancreatic or colorectal) * care partner: care partner of a patient who has received a diagnosis of metastatic lung or gastrointestinal cancer who has provided consent for study (either with our without functional mri study visits) * be able to understand study requirements and make an informed decision to participate * be able to speak and read english exclusion criteria: * life expectancy of \<8 weeks * known brain metastases * claustrophobia * both patient and care partner refuse to participate in fmri scan (ie., either patient or care partner must agree to an fmri scan in order for either to participate) * contraindications to mri (e.g.: implanted or embedded metal/metal fragments. metals in the body make the participant unable to undergo an mri which makes them ineligible for study participation).

Keywords: palliative care
novel device for rapid fluid administration

Conditions: Device Related Sepsis

Summary: the aim of the study is to determine if a new device is more effective in fluid administration than devices currently used when resuscitating pediatric patients in septic shock. this study will take place in a simulation lab setting and will not include the use of patients.

in this study, participants will be randomized to one of three devices in a pediatric intensive care unit simulation setting. each participant will be provided the device, a 1l ns bag, tubing and a 22g iv. in each scenario, the objective will be to administer 3 20cc/kg boluses within a 15 minute period to the simulated patient.

Eligibility criteria:
inclusion criteria: * pediatric emergency medicine or pediatric intensive care unit nurses, pediatric residents, medics and attendings. exclusion criteria: * inability to operate equipment due to illness or physical impairment.

Keywords: resuscitation
a study of gene edited autologous neoantigen targeted tcr t cells with or without anti-pd-1 in patients with solid tumors

Conditions: Solid Tumor

Summary: this is a first in human, single arm, open label, phase 1a/1b study to determine the safety, feasibility, and efficacy of a single dose of neotcr-p1 t cells in participants with solid tumors.


Eligibility criteria:
inclusion criteria: * histologically or cytologically documented incurable or metastatic solid tumors of the following types: melanoma, uc, ovarian cancer, colorectal cancer, breast cancer (hr+), or prostate cancer. * disease has progressed after at least one available standard therapy or no additional curative therapies are available. * measurable disease per recist v1.1 * eastern cooperative oncology group (ecog) performance status of 0 or 1 * adequate hematologic and end organ function determined within 30 days prior to enrollment. * disease-specific criteria related to the specific tumor type are required. note: there are additional inclusion criteria. the study center will determine if you meet all of the criteria. exclusion criteria: * known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, and/or inherited liver disease * known primary central nervous system (cns) malignancy or symptomatic cns metastases * uncontrolled or symptomatic hypercalcemia * pregnancy, lactation, or breastfeeding * prior allogeneic stem cell transplant or solid organ transplant * prior chimeric antigen receptor therapy or other genetically modified t cell therapy * active hiv, hepatitis b, or hepatitis c infection * active tuberculosis * severe infection within 2 weeks prior to enrollment * major surgical procedure within 4 weeks prior to enrollment or anticipation of need for a major surgical procedure during the study. note: there are additional exclusion criteria. the study center will determine if you meet all of the criteria.

Keywords: melanoma hr+ breast cancer ovarian cancer prostate cancer colorectal cancer urothelial carcinoma adoptive cell therapy neoantigen t cell receptor t lymphocyte tcr-engineered t cells personalized cell therapy cell therapy immunotherapy gene therapy pd-1 non-small cell lung cancer head and neck squamous carcinoma her2 negative breast cancer triple negative breast cancer il-2
the association of bullous pemphigoid with dipeptidyl-peptidase 4 inhibitors

Conditions: Bullous Pemphigoid

Summary: the investigators conducted a prospective study which included all patients diagnosed with biopsy-proven bp in the dermatology department of attikon hospital between april 1, 2009 and december 31, 2019. 113 consecutive patients with bp were identified. the investigators included the patients with type 2 diabetes and investigated the percentage of patients who were under treatment with dpp4-is. the specific dpp4-i prescribed was also documented.medical information including patients' age, sex, other comorbidities and concomitant medications were also recorded. furthermore, the investigators evaluated the effect of different types of treatment (topical steroids, systemic corticosteroids, immunosuppressive agents) on bullous pemphigoid.

bullous pemphigoid (bp) is the most common chronic autoimmune skin disease which is characterized by the presentation of subepidermical blisters and mostly affects elderly patients . recent studies have suggested that dipeptidyl peptidase-4 inhibitors (dpp-4is), an incretin-based drug for type 2 diabetes, as possible predisposing agents of bp . the objective of the study was to estimate the association between the use of dpp-4is and the development of bp in the setting of a tertiary university hospital and to raise awareness for everyday clinical practice, both among dermatologists as well as all physicians following patients with diabetes the study was designed as an observational prospective study.in the study included all patients who received a new diagnosis of bp and hospitalized in the dermatology department of our hospital between april 1, 2009 and december 31, 2019 inclusion criteria included a) biopsy proven bullous pemphigoid b) severe bullous pemphigoid c) recent manifestation of bullous pemphigoid (last four months).exclusion criteria included a) non bullous pemphigoid b) presentation of bullous pemphigoid more than four months c) treatment with dpp4is more than two years. overall, 113 consecutive patients with the diagnosis of bp were enrolled in the study.the investigators reviewed the percentage of patients with type 2 diabetes among all patients with bp.the number of patients who were under treatment with dpp4-is and the specific type of dpp4-is prescribed were also examined.

Eligibility criteria:
inclusion criteria: * biopsy proven bullous pemphigoid * severe bullous pemphigoid * recent manifestation of bullous pemphigoid (last four months) exclusion criteria: * non bullous pemphigoid * presentation of bullous pemphigoid more than four months * treatment with dpp4is more than two years
the effect of tesetaxel on the qtc interval and the effect of food, itraconazole, and rifampin on tesetaxel pharmacokinetics in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this is a 3-cohort, multicenter, phase 1 study of the effect of tesetaxel, an investigational, orally administered taxane, on the corrected qt (qtc) interval and the potential effect of food, a cytochrome p450 (cyp) 3a inhibitor (itraconazole), and a cyp3a inducer (rifampin) on tesetaxel pharmacokinetics (pk) in adult patients with advanced solid tumors.

cohort 1: cohort 1 is a 2-period, 2-sequence, crossover study designed to assess the effect of food on the pk of tesetaxel and tesetaxel metabolites. patients were randomized in a 1:2 ratio to receive tesetaxel on day 1 of two 21-day cycles under fed and fasting conditions in one of two opposing sequences (sequence 1a and sequence 1b). cohort 2: cohort 2 is a 2-period, single-sequence, crossover study designed to assess the potential pk drug-drug interaction (ddi) of a strong cyp3a inhibitor (itraconazole) on tesetaxel and tesetaxel metabolites. patients receive tesetaxel during cycle 1 followed by a reduced dose of tesetaxel plus itraconazole during cycle 2. cohort 3: cohort 3 is a 2-period, single-sequence, crossover study designed to assess the potential pk ddi of a strong cyp3a inducer (rifampin) on tesetaxel and tesetaxel metabolites. patients receive tesetaxel during cycle 1 followed by tesetaxel plus rifampin during cycle 2. patients in all cohorts also participate in a study designed to assess the effect of tesetaxel and tesetaxel metabolites on cardiac repolarization as measured by the change from baseline in the qtc interval over the first cycle of treatment. patients who are tolerating and benefitting from treatment with tesetaxel have the opportunity to continue onto an optional treatment extension.

Eligibility criteria:
inclusion criteria: * female or male patients at least 18 years of age * histologically or cytologically confirmed solid tumor * eastern cooperative oncology group (ecog) performance status 0, 1 or 2 * adequate cardiac conduction by ecg * adequate bone marrow, hepatic, and renal function exclusion criteria: * presence of risk factors for qtc prolongation * presence of neuropathy grade \> 1 * anticancer treatment ≤ 14 days prior to randomization * major surgery ≤ 28 days prior to randomization * less than 2 weeks or 5 plasma half-lives (whichever is greater) since last use of: * a moderate or strong inhibitor or inducer of cyp3a * a cyp3a substrate with a narrow therapeutic range or that is contraindicated with either itraconazole or rifampin

Keywords: tesetaxel itraconazole rifampin food effect qtc interval food-drug interaction drug-drug interaction pk tesetaxel metabolites advanced solid tumor
teriflunomide observational effectiveness study

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: the main goal of this investigator-initiated study is to evaluate the effectiveness and efficacy of teriflunomide in a population of relapsing remitting multiple sclerosis (rrms) patients treated in regular practice, over a period of at least two years, in the regular setting of a multiple sclerosis clinic.

consenting adult rrms patients, meeting all inclusion criteria and who have been prescribed teriflunomide by their treating physician will be asked to complete questionnaires on quality of life (qol), fatigue, and employment. the study will include 300 participants from three multiple sclerosis (ms) clinics. disease and magnetic resonance imaging (mri) activity, blood tests (aspartate aminotransferase (ast), alanine aminotransferase (alt), complete blood count (cbc)), drug compliance, side effects, toxicity, will be monitored. ms patients never treated with a disease modifying drug (dmd) and ms patients previously exposed to another dmd will be included. some would have been on a single medication, while others would have been treated with two or more medications. the results of the study will provide the patient-perceived global impacts of teriflunomide on the patient's overall quality of life. these results will also guide the physician in giving a treatment that will be adapted to the patient's major concerns.

Eligibility criteria:
inclusion criteria: * consenting relapsing remitting multiple sclerosis adults with an expanded disability status scale (edss) score ≤ 5.0 who have been prescribed teriflunomide and who agree to follow study procedures. exclusion criteria: * primary progressive or secondary progressive multiple sclerosis without relapses; other diseases that may confound evaluation of outcomes; other exclusion as per product monograph; and women contemplating pregnancy or actually pregnant.
improvement after physiotherapy for low back pain: the good responders

Conditions: Low Back Pain

Summary: this is an observational study that aims to characterize individual response of patients getting physical therapy for chronic non-specific low back pain. participants will be classified based on a questionnaire and motor tests to investigate whether individual improvement after physical therapy may be predicted. these observations may help to decide which should be the preferred treatment offered.


Eligibility criteria:
inclusion criteria: * low back pain * receiving primary care physiotherapy exclusion criteria: - -

Keywords: physical therapy modalities prognosis patient selection
register with patients in which hyperthermic intra-peritoneal chemotherapy (hipec) was performed

Conditions: Peritoneal Carcinomatosis; Pseudomyxoma Peritonei; Peritoneal Mesothelioma

Summary: the purpose of this study is to register the follow-up data of patients who, because of a peritoneal surface malignancy, will undergo cytoreductive surgery and hipec.

to register the follow-up data of patients who, because of a peritoneal surface malignancy, will undergo cytoreductive surgery and hipec. in this surgical intervention, the abdominal cavity is macroscopically cleared of tumor, by removing all visible tumor nodules, and is subsequently rinsed with hyperthermic (heated) chemotherapy, aiming to destroy all residual invisible tumor cells that might have stayed behind after the debulking. the eventual aim of this procedure is to improve the prognosis/survival of patients with malignancies localized on the peritoneal surface.

Eligibility criteria:
inclusion criteria: * patients with peritoneal carcinomatosis of colorectal origin, patients with pseudomyxoma peritonei (type dpam or pmca) and patients with peritoneal mesothelioma who are planned to undergo cytoreductive surgery and hipec because of a peritoneal surface malignancy

Keywords: hipec hyperthermic (heated) chemotherapy after debulking
a pharmacokinetic and pharmacodynamic study of pf-04950615 (rn316) in subjects with hypercholesterolemia

Conditions: Hypercholesterolemia; Dyslipidemias; Hyperlipidemias; Lipid Metabolism Disorders; Metabolic Diseases

Summary: this phase 1 study has been designed to evaluate the absolute bioavailability of pf-04950615 (rn316) in subjects with hypercholesterolemia who are not currently on lipid-lowering therapy.


Eligibility criteria:
inclusion criteria: * fasting ldl-c greater than or equal to 130 mg/dl at two qualifying screening visits. * total body weight greater than or equal to 50 kg (110 lbs) and less than or equal to 150 kg (330 lbs) exclusion criteria: * lipid-lowering prescription medications, homeopaths, herbal medicines, or nutritional supplements. * poorly controlled type 1 or type 2 diabetes. * history of a cardiovascular or cerebrovascular event or related procedure during the past year. * poorly controlled hypertension.

Keywords: pf-04950615 rn316
a pilot study of the alpfa benign prostatic hyperplasia (bph) pulsed field ablation (pfa) system

Conditions: Benign Prostatic Hyperplasia

Summary: the alpfa medical bph pilot study is a prospective, open label, single arm pilot study to assess the use of the alpfa bph pfa system in the treatment of men over the age of 45 with obstructive urinary symptoms associated with bph. male subjects will be consented and undergo protocol-defined baseline assessments. those who meet study entry criteria will be enrolled and treated with the alpfa bph pfa system and then undergo follow-up with protocol-defined assessment.


Eligibility criteria:
inclusion: 1. patients who are ≥ 45 years of age on the day of enrollment. 2. patients who have failed to achieve satisfactory resolution of bph symptoms using an approved medication. 3. life expectancy: the patient has a life expectancy of ≥ 1 year 4. patient participation: the patient 1. is free of physical, psychological or other impairment that would prevent their ability to understand and comply with all study requirements. 2. is willing and capable of providing informed consent to undergo study procedures. 3. agrees to fully participate in all examinations, study requirements, follow-up visits and tests associated with this clinical study. 4. lives close enough to the investigational site to facilitate the required in-person visits. exclusion: 1. urologic conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or confound data or its interpretation, including but not limited to: 1. previous operative intervention for bph 2. active urinary tract infection (may be treated and enrolled upon negative urine culture). 3. prostatitis: a history of any prostatitis within 2 years of enrollment. 4. cystolithiasis active within 90 days of enrollment 5. artificial sphincters. 2. bladder cancer: a history of treated bladder cancer of stage t2 or higher, or a clinical suspicion of bladder cancer 3. medical conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or confound data or its interpretation, including but not limited to: a. unstable cardiovascular disease including: i. nyha iii/iv heart failure or lvef \< 40% ii. uncontrolled arrhythmia iii. stroke, tia, thromboembolic event, myocardial infarction, unstable angina, percutaneous coronary intervention or any cardiac surgery within 90 days of enrollment iv. uncontrolled hypertension b. immunosuppression: known immunosuppression, including but not limited to aids, immunosuppressive medication or current chemotherapy. c. coagulopathy: diagnosed disorder of blood clotting or bleeding diathesis. d. transplant: history of any solid organ or hematologic transplant, or currently being evaluated for an organ transplant e. active substance abuse: active alcoholism or
the impact of occupational therapy : a multicenter randomized controlled trial

Conditions: Elderly Patient; Cancer; Quality of Life

Summary: the purpose of this randomized controlled superiority trial is to evaluate the impact of occupational therapy assessment and intervention on the quality of life of elderly cancer patients. patients will be randomized into 3 parallel, multicenter arms with patient-reported outcome and blinded evaluator. * experimental group a will combine the assessment of occupational problems (mcro) and an occupational therapy intervention. * experimental group b will have only the mcro assessment because the occupational problems assessment alone (without intervention) could improve quality of life and occupational performance outcomes, according to the nielsen, 2019 study * group c will have the usual cancer management care combining specific treatments and supportive care.

in order to limit the potential grading bias associated with the open-label design, the reassessment at 3 and 6 months will be performed by a different occupational therapist than the one who performed the initial assessment and occupational therapy intervention. for this reason, at least two occupational therapists per geographic area of the centers that include the patients will be included in the project.

Eligibility criteria:
inclusion criteria: * ≥ 70 years; * colorectal, breast, prostate or lung cancer; * between 1 and 3 months after the start of cancer treatment depending on the type of treatment (surgery and/or systemic treatment and/or radiotherapy); * for curative purposes; * affiliated to a social security scheme; * living at home; * agreeing to participate in the research and having given a free, informed and signed consent exclusion criteria: * person caring for a patient meeting the above criteria; * living with the patient; * agreeing to participate in the research and having given free, informed and signed consent
safety and efficacy study of bosutinib in patients with philadelphia chromosome positive chronic myeloid leukemia previously treated with one or more tyrosine kinase inhibitors

Conditions: Previously Treated PH + CML

Summary: the purpose of this study is to fulfill the post-authorization commitment made by pfizer to the european medicines agency in providing additional safety and efficacy data in approximately 150 philadelphia chromosome positive chronic myeloid leukemia patients with high unmet medical need, including 75 chronic phase, accelerated phase or blast phase patients in the fourth or later line treatment setting (i.e., after treatment with at least 3 other tyrosine kinase inhibitors).


Eligibility criteria:
inclusion criteria: * confirmed philadelphia chromosome positive chronic myeloid leukemia or confirmed bcr-abl1 (abelson-break point cluster) positive if philadelphia chromosome negative chronic myeloid leukemia (from initial diagnosis). * prior treatment with 1 or more tyrosine kinase inhibitor drugs (imatinib, dasatinib and/or nilotinib) for philadelphia chromosome positive chronic myeloid leukemia (cml). * any chronic myeloid leukemia disease phase, as long as the patient is unable to receive treatment with imatinib, dasatinib and/or nilotinib for any reason. exclusion criteria: * participation in any other clinical studies involving investigational drug(s) within 14 days or within 3 half-lives of drug levels in blood (whichever is longer) prior to the first dose of bosutinib. * prior treatment with bosutinib. * prior treatment with ponatinib. * known t315i or v299l mutation.

Keywords: bosutinib chronic myeloid leukemia cml leukemia myelogenous chronic bc-abl positive