Kornimate/medical-research-clean huggingface dataset:
cabazitaxel in asian patients with advanced gastric cancer who failed prior chemotherapy

Conditions: Gastric Cancer

Summary: primary objective: - to evaluate the anti-tumor activity of cabazitaxel by assessing objective tumor response rate (orr) at the recommended dose (rd) when administered as a single agent every 3 weeks in patients with advanced gastric adenocarcinoma who have failed prior chemotherapy regimens secondary objectives: * to determine the rd of cabazitaxel when administered as a single agent every 3 weeks * to evaluate safety of cabazitaxel when administered as a single agent every 3 weeks * to estimate the overall survival (os) and progression free survival (pfs) * to assess the pharmacokinetics (pk) profile of cabazitaxel in part 1

patients will be treated until disease progression, unacceptable toxicity, or patient's refusal of further study treatment. all patients will be followed during and after the study treatment until death or the end of study, whichever comes first.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed unresectable or metastatic gastric adenocarcinoma including adenocarcinoma of gastroesophageal junction, which have failed 2 prior chemotherapy regimens. (for countries where a standard of care has not been established for the 2nd line treatment for advanced gastric cancer, those who failed 1 or 2 prior chemotherapy regimens can be included) * signed informed consent exclusion criteria: * patients who have received \>2 prior systemic chemotherapy regimens for advanced gastric cancer. * for patients entering part 2, those without at least one measurable lesion at baseline according to response evaluation criteria in solid tumors 1.1 criteria * eastern cooperative oncology group performance status \>1 * age \<18 years * inadequate organ and bone marrow function * prior surgery, chemotherapy, targeted agents, investigational agents, or other anti-cancer therapy within 4 weeks prior to enrollment in the study * prior radiation therapy within 6 weeks prior to enrollment (except palliative radiation for a local pain control) * previous treatment with cabazitaxel * known brain or leptomeningeal involvement of cancer * patients with known acquired immunodeficiency syndrome (aids) related illness or known hiv infection requiring antiretroviral treatment. * patients with active varicella zoster infection, or known hepatitis b or c infection. * history of severe hypersensitivity reaction ≥ grade 3 to drugs formulated with polysorbate 80 such as docetaxel the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
determine range of tissue frataxin concentrations and other potential biomarkers

Conditions: Friedreich Ataxia; Healthy Volunteers

Summary: to examine range of tissue frataxin (fxn) concentrations, specific ribonucleic acids, other proteins and specialized lipids in the buccal cells, blood, and skin cells of normal healthy volunteers without friedreich's ataxia (frda).

primary objective: to examine the range of tissue frataxin (fxn) concentrations in the buccal cells, blood, and skin cells of normal healthy volunteers without frda. secondary objective: to examine the range of specific ribonucleic acids (rnas), other proteins, and specialized lipids in the buccal cells, blood, and skin cells of normal healthy volunteers without frda.

Eligibility criteria:
inclusion criteria: 1. subject is a healthy male or female,18-50 years of age 2. subject has a body mass index (bmi) ≥18.0 and ≤32.0 as of the screening visit. 3. subject is racially caucasian, asian, native hawaiian, or native american. exclusion criteria: 1. subject used erythropoietin, etravirine, or gamma interferon within 3 months prior to the day 1 (assessment) visit. 2. subject has a chronic condition that requires ongoing prescription drug treatment. 3. subject use of any statin medications within 3 months before the day 1 (assessment) visit. 4. subject use of any lipid-lowering agents, other than statins, within 6 weeks before the day 1 (assessments) visit. 5. subject is racially black or african american. 6. pregnant or breast-feeding female subjects. 7. subject has a known history of drug or alcohol abuse or current suspected drug or alcohol abuse. 8. subject is positive for human immunodeficiency virus (hiv), hepatitis c virus (hcv), hepatitis b surface antigen (hbsag), or hepatitis a virus (hav). 9. subject has any condition, disease, or situation, that in the opinion of the principal investigator (pi), could confound the results of the study or put the subject at undue risk, making participation inadvisable.
efficacy of different types of exercises in women with fibromyalgia syndrome.

Conditions: Fibromyalgia Syndrome

Summary: objective: to demonstrate the most effective exercise intervention for women with fibromyalgia syndrome on the pain, quality of life, depression, and body composition through a comparative study of three types of exercise intervention: supervised aerobic plus stretching, supervised resistance plus stretching, and home-based stretching.

objective: to demonstrate the most effective exercise intervention for women with fibromyalgia syndrome on the pain, quality of life, depression, and body composition through a comparative study of three types of exercise intervention. methods: eighty-four patients women with fibromyalgia syndrome were assigned to three groups: supervised aerobic plus stretching exercises group (group i, n:28), supervised resistance plus stretching exercises group (group ii, n:28) and home-based stretching exercises group (group iii, n:28). the target heart rate (hr) corresponding to values of 50-70 % ergospirometric vo2max were determined by the submaximal treadmill test. group i was instructed walking at their target hr on a treadmill. exercise intensity in group ii was determined by one-repetition maximum (1rm) measurements. group iii was instructed to exercise at home. all participants were instructed to perform stretching exercises. before and after a 12-week exercise program, participants were evaluated by weight, body mass index (bmi), total body fat and muscle percentage, visual analog scale (vas), fibromyalgia impact questionnaire (fiq), short form-36 (sf-36) and beck depression inventory (bdi). study type: interventional (clinical trial)

Eligibility criteria:
inclusion criteria: * eligible participants who meet the criteria for inclusion were women with fibromyalgia syndrome diagnosis according to acr 2016 fibromyalgia diagnostic criteria and were 18-65 years old. * participants were well communicative, motivated, and willing to participate in the study. exclusion criteria: • the exclusion criteria were the presence of uncontrolled hypertension, history of myocardial infarction or coronary artery disease, unstable angina pectoris, class 3-4 heart failure (new york heart association), musculoskeletal or systemic diseases contradicting the exercise, a neurological or psychiatric disease affecting cooperation and cognitive function, presence of active inflammation and immunosuppression.

Keywords: fibromyalgia aerobic exercise resistance exercise stretching exercise
a prospective study of brain network activation (bna) changes in high school athletes following concussion

Conditions: Mild Traumatic Brain Injury

Summary: the main purpose of this study is to prospectively examine changes in brain network activation(bna)following concussion in high school athletes. in addition, the study will examine the relationship between changes in bna to symptoms, cognitive performance and vestibular function from baseline to 1-7, 8-14 and 15-21 day post injury intervals in high school athletes with concussion.


Eligibility criteria:
inclusion criteria: * aged 13-18 years * able to speak, read and understand english sufficiently to understand the nature of the study, and to allow completion of all study assessments * willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self) exclusion criteria: * current or history of tbi (i.e., glasgow coma scale \<13) or brain surgery * current or history of any psychiatric disorder (except add/adhd), e.g., depression, bipolar disorder, schizophrenic disorder * substance abuse within the last year * current or history of special education, e.g., reading disorder (dyslexia), writing disorder (dysgraphia), math disorder (dyscalculia), nonverbal learning disorder * current or history of any neurological disorder, e.g., epilepsy, seizures * history of any medication affecting cns within the last year, e.g., antidepressants, anticonvulsants, ritalin, first generation antihistamines, etc. * current or history of significant sensory deficits such as deafness or blindness * current or history of clinically significant abnormal laboratory values or ecg * a concussion within the last year * current or history of residual symptoms or deficits related to a previous concussion * diagnosis of autistic spectrum disorders, e.g., asperger's syndrome, high functioning autism, pdd * currently with lice or open wounds on scalp * long and thick hair that prevents the proper administration of an eeg cap

Keywords: mild traumatic brain injury mtbi concussion
home airway clearance in cf patients

Conditions: Pulmonary Cystic Fibrosis

Summary: regular bronchial clearance is essential in patients with cystic fibrosis for their bronchial health. simeox® (physio-assist, aix en provence, france) is an innovative medical device for the drainage of the bronchial tree. by changing the rheological properties of mucus, simeox® helps to mobilize secretions and assists their transport to the upper airways. this technology is based on fundamental research on bronchial mucus rheology. at the present time, simeox® device is mainly used over a short period at the time or after an exacerbation in healthcare structures (hospitals, physiotherapy practices, post-care, and rehabilitation units, etc...). the clinical effects observed in the short term encourages long-term autonomous use by the patients themselves. the overall objective of this study is to evaluate the efficiency and acceptability of simeox® used at home by the patient himself for bronchial clearance in patients with cystic fibrosis.


Eligibility criteria:
inclusion criteria: * patient diagnosed with cystic fibrosis * stabilization of the disease, defined by an at least 4 weeks period since the end of an exacerbation, stabilization will be let to investigator's judgment. * age \>12 * requiring at least 1 bronchial clearing session each week (regardless of the technique) * patient (or patient's legal representative if applicable), capable to read and understand the procedure, and capable to express consent for the study protocol. exclusion criteria: * severe pneumothorax or hemoptysis (more than 30ml per 24 hours) within 6 weeks before the inclusion day. * patient placed on a transplant waiting list * any contraindication to an instrumental bronchial clearance technique * patients already own and use simeox at home * unavailable patient or patient wishing to move to a different region within three months after inclusion. * patient currently participating or having participated to another interventional clinical research within a month prior inclusion date, that may impact the study, this impact is left to the investigator's judgment. * persons referred by the french public health code to articles l1121-5 to l1121-8 (includes all protected persons: pregnant women (confirmed by measurement of the serum human chorionic gonadotropin level for any woman wishing to enter the protocol and under childbearing age \< 60), parturient woman, breastfeeding mother, everyone deprived of his liberty by judicial or administrative decision, everyone subject to a legal protection measure. * initiation of treatment with a cftr modulator within the last 3 months

Keywords: bronchial clearance cystic fibrosis
multiple ascending dose (mdx1105-01)

Conditions: Cancer, Multiple Indications

Summary: collection of survival data, evaluation of pdl-1 expression in tumors, and evaluation of pd-l1 receptor occupancy in peripheral blood has been added.

this is an open label, multicenter, dose escalation and multidose study of mdx-11-5, a fully human monoclonal igg4 antibody targeting the programed death-ligand 1 (pd-l1). the study will consist of 3 periods: screening (up to 28 days), treatment (up to 16 six-week cycles), and follow-up (up to 6 months).

Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status 0 to 1 * the malignancies include relapsed/refractory renal cell carcinoma, non-small cell lung cancer, colorectal adenocarcinoma, malignant melanoma, advanced/metastatic epithelial ovarian cancer, gastric cancer, pancreatic cancer and breastcancer * must have measurable disease exclusion criteria: * prior therapy with an anti-pd 1, anti-pdl 1, or anti-cytotoxic t-lymphocyte antigen 4 antibody (or any other agents that target t-cell co-stimulation)
delayed cord clamping in vlbw infants

Conditions: Infant, Newborn; Infant, Low Birth Weight; Infant, Small for Gestational Age; Infant, Premature

Summary: this study tested the feasibility of conducting a randomized controlled trial to vary the timing that doctors clamp the umbilical cord after birth in extremely low birthweight infants. the study also tested whether delaying cord clamping by 30-35 seconds and holding the newborn approximately 10 inches below the birth canal would result in increased hematocrit at 4 hours of age.

this study tested the hypothesis that delaying clamping of the umbilical cord in extremely low birthweight (elbw) infants would result in additional blood transfusion from the placenta to the baby, increasing the infant's blood volume and blood pressure. higher blood pressure may improve blood flow to the brain that may reduce potential the risk of hypoxic ischemic encephalopathy (hie) and/or intraventricular hemorrhage (ivh). the additional placental flow may also increase the amount of stem cells and cytokines flowing to the baby, improving immune status and reducing the risk of infection, while at the same time reducing the need for blood transfusions in the neonatal period. this was a pilot study to test the feasibility of having obstetricians delay cord clamping for 30-45 seconds, and to confirm whether the procedure significantly increases the baby's hematocrit during the first 4 hours of life.

Eligibility criteria:
inclusion criteria: * infants born at participating centers at 24-27 weeks gestation * singletons * obstetrician approval for enrollment * parental consent exclusion criteria: * prenatally diagnosed major congenital anomalies * intent to withhold or withdraw care * significant bleeding due to placenta previa or abruption

Keywords: nichd neonatal research network extremely low birth weight (elbw) very low birth weight (vlbw) prematurity
video game-based exercise for persons with parkinson's disease

Conditions: Parkinson Disease

Summary: this study assessed the effects of interactive video game-based exercise (ivgb) on balance in persons with parkinson's disease . twenty-four patients were randomly allocated to two groups (12 participants per group). group a underwent ivgb training for the first 6 weeks, with no exercise in the subsequent 6 weeks. group b had no exercise for the first 6 weeks and then received ivgb training in the subsequent 6 weeks. both subjective and objective measures were used to determine whether ivgb exercise improves balance function.

the experiments were conducted as a prospective, randomized, single blinded, crossover, 12-week trial. the group a undergoes the ivgb training in the initial 6 weeks (intervention phase), follows by suspended from exercise in the subsequent 6 weeks (control phase). the group b does not received treatment in the first 6 weeks (control phase), and then performs ivgb training in the following 6 weeks (intervention phase). for all participants, the 36-item short-form health survey (sf-36), modified falls efficacy scale (mfes), berg balance scale (bbs), multidirectional reach test (mdrt) and maximum step length (msl) test were assessed at weeks 0, 6, and 12 of the experiment.

Eligibility criteria:
inclusion criteria: * medical diagnosis of idiopathic parkinson's disease * independent community ambulatory individuals * capable of giving informed and written consent (mini-mental status examination (mmse)\>23) exclusion criteria: * the other neurological conditions such as dementia, and stroke, or if they have arthritis, vision impairment, * cardiovascular disease that impair walking, or diabetic and uremic individuals, or if they were unable to walk without assistance.
decreasing edema with platysma exercises following third molar extraction surgery

Conditions: Third Molar Extraction

Summary: this study will investigate the effects of a platysma muscle exercise on edema following third molar extraction surgery.

the investigators hypothesized that, during the muscle contraction of the platysma, the vascular structures will be subjected to a pump effect, leading to an increase in venous circulation. additionally, due to its connection to the fascia, the investigators propose that platysma contractions may mobilize the fascia and stimulate the lymph nodes, thereby improving interstitial fluid flow. this could lead to an effective treatment option for decreasing edema after third molar tooth extraction. therefore, this study aims to investigate the effects of platysma exercises applied after third molar tooth extraction on edema while observing the differences on pain and trismus.

Eligibility criteria:
inclusion criteria: * patients aged 18-40, * those requiring impacted third molar extraction * those with no systemic health conditions, were included in the study * those who accepted to participate in the study exclusion criteria: * those who had systemic diseases * those who were taking medications that could interfere with inflammation, or healing, * those who were pregnant or breastfeeding, * those who had infections or pathologies involving teeth 38 and 48, * those who were unable to comply with postoperative recommendations or required therapeutic interventions outside the study protocol

Keywords: third molar extraction platysma muscle exercise edema
near-infrared spectroscopy of auricular stimulation

Conditions: Healthy Male and Female Subjects; Healthy Volunteer Study

Summary: this is a single-visit non-invasive study of healthy volunteer subjects. brain activity will be measured with infra-red light sensors attached to a cap worn on the head, while both ears are gently stimulated with plastic filaments.

the aim of this study is to localize and quantify brain activations from experimental stimulation of auricular points in pain-free volunteers. investigators will stimulate auricular points for the shoulder, thumb, and lumbar spine with von frey filaments and measure functional near-infrared spectroscopy (fnirs) responses in the primary somatosensory (s1) and prefrontal cortex (pfc). this will test the hypothesis that stimulation across different points in the auricular cartography maps to distinct brain responses, an assumption underpinning at theory. stimulation of different ear points is anticipated to induce similar pfc responses, but activate distinct areas within the s1 homunculus, validating the concept of auricular cartography.

Eligibility criteria:
inclusion criteria: age of at least 18 years exclusion criteria: 1. frequent or chronic pain requiring the use of pain-relieving medications more than twice per week, on average, in the last 3 months, 2. history or symptoms of neuropathy, 3. active lesions or skin disruptions to either ear, 4. recent (\< 3 mo) illicit drug use, 5. history of substance misuse/abuse, 6. current or recent (\<1 month) opioid or marijuana use, and 7. current regular use of psychoactive prescription medications

Keywords: auricular stimulation functional near infrared spectroscopy
mitral loop cerclage(mlc) for reducing functional mitral regurgitation

Conditions: Functional Mitral Regurgitation; Heart Failure

Summary: to evaluate safety and feasibility of mitral loop cerclage(mlc) annuloplasty with cstv for repair of functional mitral regurgitation.

the objective of this prospective, single-center, open label, feasibility test is to assess the safety and efficacy of mitral loop cerclage annuloplasty with cstv protective device in treating functional mitral regurgitation (fmr) associated with heart failure.

Eligibility criteria:
inclusion criteria: * nyha(new york heart association) class iii - iv, and symptomatic severe functional mr by 2014 acc/aha guideline in spite of optimal medical treatment. (for optimal medical treatments, ①ace inhibitor or angiotensin receptor blocker ②β-blocker ③ aldosterone antagonists should be given for at least 3 months unless the subject has contraindication for each drug) exclusion criteria: * primary mitral regurgitation * lv ejection fraction lower than 25% * creatinine ≥2.0 mg/dl * anomaly of coronary sinus * pre-existing devices in coronary sinus such as implantable cardioverter defibrillator and pacemaker * 2:1 atriventricular av block or higher av block and ventricular tachycardia * subjects with functional mr who need cabg or avr performed * subjects who have functional mr caused by aortic valve disease * subjects who have uncontrollable hyperthyroidism * subjects who have severe tr due to primary valve leaflet disease * subjects who cannot be screened by cardiac ct * subjects who have possibility of coronary artery pinching even with mitral loop cerclage system judged by cardiac ct * subjects who are unable to take anti-platelet agents * subjects who are participated in other clinical trials within 1 month of enrollment * subjects who have coagulation disorders * subjects who have thrombosis and embolism * subjects who are pregnant, or lactating, or plan pregnancy during the clinical trials * subjects who are deemed not to be eligible in this study by physician's discretion

Keywords: percutaneous mitral valve repair coronary sinus annuloplasty mitral loop cerclage