Kornimate/medical-research-clean huggingface dataset:
breast cancer exercise intervention study

Conditions: Early-stage Breast Cancer; Locally Advanced Breast Cancer

Summary: this is a 24-week exercise programme consisting of aerobic exercise and muscle strength training, 3 sessions per week. the first 9 sessions are supervised by physiotherapists in person, followed by 63 sessions monitored remotely (video) or supervised by trainers at activesg (sport singapore) gyms.

this is a multi-centre, randomised controlled study of a 6-month (24-week) exercise programme versus observation in 2156 early stage and locally advanced breast cancer patients who have undergone curative breast surgery, and who have completed (neo)adjuvant chemotherapy (if given) or radiotherapy (if given). patients are stratified by centre (ncc/sgh, nuh), menopausal status, er/pr status, body fat/muscle ratio. cardiorespiratory fitness, muscle strength, level of routine daily physical activity, body fat/muscle ratio are monitored during the study period. blood is collected at baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks, then annually for 4 times. questionnaires are periodically conducted to assess quality of life (qol). a food diary is kept.

Eligibility criteria:
inclusion criteria: * patients with histologically or cytologically proven stage 1, 2, or 3 breast cancer * patients who have undergone curative breast surgery * patients who have received (neo)adjuvant chemotherapy (if given) and/or radiotherapy (if given) * females aged 21 years and older * ≤ 8 weeks from breast surgery, or the last adjuvant chemotherapy or radiotherapy session, whichever is latest. exclusion criteria: * cardiovascular, respiratory, musculoskeletal problems that preclude moderate physical activity. * major medical problems that are deemed by the investigator to be unsuitable for enrollment.

Keywords: brexint muscular strength cardiorespiratory fitness quality of life
vibracool device to reduce pain and opioid use after anterior cruciate ligament reconstruction (aclr)

Conditions: ACL; Opioid Use; Cryotherapy Effect; Vibration; Exposure; Pain, Postoperative

Summary: the goal of this project is to test the effects of the vibracool mechanical stimulation neuromodulatory therapeutic device on post-operative pain and opioid use following anterior crucitate ligament reconstruction (aclr), and thus residual opioids in circulation.


Eligibility criteria:
inclusion criteria: * underwent acl reconstruction exclusion criteria: * pediatric iliotibial band acl reconstruction (known to cause significantly more pain) * non-english speakers (limitations of our study group)
to compare the efficacy and safety of layla in osteoarthritis patients

Conditions: Osteoarthritis of the Knee

Summary: this is a randomized, double-blind study to compare the efficacy and safety of layla tablet and joins tablet in the treatment of osteoarthritis of the knee.


Eligibility criteria:
inclusion criteria: * patients ≥40 and ≤ 80years of age * radiographic evidence of grade 2 or 3 osteoarthritis based on the kellgren \& lawrene radiographic entry criteria * stable osteoarthritis during 3 months * score of 100mm pain vas ≤ 80mm at screening * score of 100mm pain vas ≥ 50mm at baseline * written consent form voluntarily exclusion criteria: * disease of spine or other lower limb joints that could affect to evaluate the efficacy * history of surgery or arthroscopy of the study joint within 6 months * trauma of study joint within 12 months * medication of constantly(more than 1 week) corticosteroid by oral within 3 months * medication of intra-articular injection within 3 months * diagnosed with psychical disorder, and taking medication * history of upper gastrointestinal ulceration within 6 months * history of upper gastrointestinal bleeding within 12 months * serum creatinine, alt, ast, total bilirubin over unl x 2.0 at screening test * history of hypersensitivity to layla, joins, or nsaids * participation in another clinical trials within 4 weeks * medication of constantly (more than 1 week) narcotic analgesics within 3 months * not consent about using effectual contraception method during trial * pregnant or lactating woman * investigator's judgment

Keywords: layla non-inferiority 100mm pain vas
non-small cell lung cancer study us75 (z-pact)

Conditions: Non Small Cell Lung Carcinoma

Summary: this study will evaluate the effects of an investigational drug in combination with chemotherapy in patients with stage iiib/iv non-small cell lung cancer. this study will measure the effects of this combination on progression of lung cancer, cancer response to treatments, and development of cancer-related bone lesions.


Eligibility criteria:
inclusion criteria: * male or female patients at least of 18 years old * patients with diagnosed non-small cell lung cancer that cannot be treated by surgery * women must not be pregnant or attempting to become pregnant * able and willing to sign informed consent exclusion criteria: * patients with cancer that has spread to the bone * patients with cancer that has spread to the brain who are receiving treatment * patients with kidney disease * patients treated with other investigational drugs

Keywords: lung cancer zpact us75 bone metastases
action observation therapy for lower limb in stroke

Conditions: Stroke

Summary: this study focuses on the effects of action observation therapy on stair walking, balance and self-efficacy in chronic stroke patients. this study will be conducted in helping hands institute of rehabilitation sciences and shifa surgical hospital mansehra. it is a randomized control trial. non probability convenient sampling technique will be used to assess a total number of 40 respondents. questionnaires and consent forms will be filled by the respondents. each patient will be screened by using a simple selection performa relevant to inclusion and exclusion criteria. total 30 patients will be included in the study and then divided into two groups i.e. action observation therapy and convention therapy group with 15 individuals in each. each group will be assessed thrice i.e. pre, post and follow up surveys. each of them will receive the convention therapy for 30 mins except for the action observation therapy (aot) group, which will also receive the additional 30 minutes session of action observational training. total 18 sessions, 3 days a week for a total of six weeks will be performed on each patient. fugel meyer assessment scale for lower limb, timed up and go test, timed stair test, step test and self-efficacy scale will be used for the assessment. baseline assessments of both group will be done on 1st week before the application of protocol, second assessment will be done on 4th week and then final assessment will be done on 6th week of the protocol.


Eligibility criteria:
inclusion criteria: * age between 40-60 years. * both male and female. * those who can walk more than 10 steps. * more than 6 months since stroke onset. * ability to follow the study instructions-mini mental state examination (mmse) score ≥25 * baseline score of the fugel meyer assessment scale is between20 and 60. * score of 3 on modified rankin scale (mrs). exclusion criteria: * patients who cannot perform the active movement of upper limb in pre-stroke condition due to musculoskeletal problems. * cardiopulmonary diseases which could hinder their ability to participate in the rehabilitation program in this study. * patients with impaired cognition. * orthopedic injuries
population pharmacokinetics of cephalosporins and macrolides in chinese children with community acquired pneumonia

Conditions: Community Acquired Pneumonia

Summary: this study is based on the hypothesis that the pharmacokinetics of antibiotics in children is different from adults. cephalosporins and macrolide antibiotics are the common drugs for children with community acquired pneumonia, the investigators aim to study the population pharmacokinetics of cephalosporins and macrolide antibiotics in children receiving the drug for treatment of community acquired pneumonia, and to correlate it with treatment effectiveness and incidence of adverse effects. potential impact: this novel knowledge will allow better and more rational approaches to the treatment of community acquired pneumonia. it will also set the foundation for further studies that will be able to test improved therapies that may increase treatment response in vulnerable children.


Eligibility criteria:
inclusion criteria: * children 1-18 years old of both sexes, with a diagnosis of community acquired pneumonia and eligible for treatment with cephalosporins and macrolide antibiotics, as per current treatment protocols. * community acquired pneumonia diagnostic criteria: meet any one of the 1-4 following items plus the fifth item: * 1. with cough, expectoration, or pre-existing respiratory disease getting worse, and with purulent sputum with or without chest pain; * 2. fever; * 3. with pulmonary consolidation and crackles; * 4. white blood cells\>10×10\^9/l or \<4×10\^9/l; * 5. x-ray on chest shows flake, patchy infiltrate shadows or interstitial changes, with or without pleural effusion. * informed consent signed by the parents, and consent or assent of the patients (according to age and consenting capacity). exclusion criteria: * it is unable to provide complete medical records or the current condition can not accept the diagnosis process. * it does not agree to participate in this study.
spearhead 1 study in subjects with advanced synovial sarcoma or myxoid/round cell liposarcoma

Conditions: Synovial Sarcoma; Myxoid Liposarcoma

Summary: this is a study to investigate the efficacy and safety of adp-a2m4 in hla-a\*02 eligible and mage-a4 positive subjects with metastatic or inoperable (advanced) synovial sarcoma (cohort 1, 2 and 3 ) or mrcls (cohort 1) .


Eligibility criteria:
key inclusion criteria * age ≥16 (10 years at selected sites) and \<=75 years * diagnosis of advanced synovial sarcoma (cohort 1, cohort 2 and cohort 3) or myxoid liposarcoma / myxoid round cell liposarcoma (cohort 1 only) confirmed by cytogenetics. * previously received either an anthracycline or ifosfamide containing regimen. * measurable disease according to recist v1.1 prior to lymphodepletion * hla-a\*02:01, hla-a\*02:02, hla-a\*02:03 or hla-a\*02:06 positive * tumor shows mage-a4 expression confirmed by central laboratory. north america only (united states and canada): tumor (either an archival specimen or a fresh biopsy) shows mage-a4 expression of ≥1+ staining in ≥10% of the cells by immunohistochemistry. * ecog performance status of 0 or1. for subjects aged ≥10 to ≥16 years old: lansky score ≥60%. • left ventricular ejection fraction (lvef) ≥50%. note: other protocol defined inclusion criteria may apply key exclusion criteria: * hla-a\*02:05 in either allele * received or plans to receive the following therapy/treatment prior to leukapheresis or lymphodepleting chemotherapy: cytotoxic chemotherapy, tyrosine kinase inhibitor (tki) (e.g. pazopanib), immune therapy (including monoclonal antibody therapy, checkpoint inhibitors,), anti-cancer vaccine, gene therapy using an integrating vector (subjects who have received a gene therapy using a lentiviral vector may be eligible for the study), corticosteroids or any other immunosuppressive therapy, investigational treatment or interventional clinical trial, allogeneic hematopoietic stem cell transplant, radiotherapy to the target lesions, major surgery * history of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study. * history of autoimmune or immune mediated disease * symptomatic cns metastases including leptomeningeal disease. * other prior malignancy that is not considered by the investigator to be in complete remission * clinically significant cardiovascular disease * uncontrolled intercurrent illness * active infection with human immunodeficiency virus, hepatitis b virus, hepatitis c virus, or human t cell leukemia virus * pregnant or breastfeeding note: other protocol defined exclusion criteria may apply.

Keywords: cell therapy t cell therapy spear t cell sarcoma mrcls mage a-4 immuno-oncology
virtual reality during intrathecal pump refills in children

Conditions: Cerebral Palsy

Summary: the aim of the current study is to explore the effect of virtual reality on pain in children who undergo an intrathecal pump refill compared to usual care and distraction.

virtual reality (vr) is a technological rehabilitation tool that allows the user to experience the interaction with a computer-generated environment. it may provide some advantages over conventional care: it allows the simulation of realistic environments and patients feel more motivated by this kind of virtual environment. vr constitutes an enriched environment with augmented multiple sensory feedbacks (auditory, visual, tactile vr enriched environment) that has already shown some efficiency in reducing chronic pain. there is mounting evidence from acute pain conditions, such as wound care, that vr could play a role as an additional treatment method to relieve pain a possible explanation for its mechanism of action is provided by "the gate-theory of attention". vr reduces the perception of pain by diverting attention away from the pain. most children experience pain and fear when receiving a medical treatment; two feelings which are closely related and affecting one another. moreover, children often describe procedures involving needles as the most stressful portion of the hospital experience. children who have been implanted with an intrathecal baclofen (itb) pump, need to come to the hospital for a refill approximately every 3 months, depending on the exact dose. during the refill, the physician places a needle directly into the reservoir to refill the pump. to alleviate the pain and fear with these refill procedures, it is hypothesized that vr could alleviate pain and make these refills more feasible. therefore, the aim of this study is to evaluate whether vr is reducing pain during a refill procedure, in children receiving intrathecal drug delivery compared to usual care.

Eligibility criteria:
inclusion criteria: * children with cerebral palsy between 8 and 16 years who have an implanted pump for intrathecal drug delivery * child and parents have been informed of the study procedures and have given written informed consent * child and parents willing to comply with study protocol * child and parents are able to speak dutch/french (questionnaires) * cognitive and language functioning enabling communication between the physician/researcher and the child exclusion criteria: * children with susceptibility to motion sickness or cyber-sickness * children with susceptibility to claustrophobia * history of seizures/epilepsia

Keywords: virtual reality
measurement of grip and pinch forces needed for activities of daily living, work and prehistoric stone tool production

Conditions: Basilar Thumb Arthritis; Wrist Fracture; Measure Pressure Distribution and Resultant Forces Needed

Summary: very little is known about the pinch and grip forces that are critical for activities of daily living (adl) or work. human success in evolution is a result of the combination of great brain power and great hand ability to accomplish with our hands what our minds can conceive. prehensile grasp in hominins allowed tool production and today allows us to hold fine instruments to perform surgery or do heavy construction. the strength of our hands is matched against the requirements of the activities we need to perform. the hypothesis of this study is that many tasks have an inherent strength requirement that is independent of the person performing the task. until recently, direct measurement of the forces has not been possible. ultra thin sensors along with the software to interpret the information is now available to make this force determination possible. we have 3 primary objectives. the primary objective is to measure pressure distribution and resultant forces needed for 3 categories of adl and 2 categories of work in normal subjects. the second objective is to perform a similar evaluation of patients with basilar thumb arthritis and after wrist fracture. the third objective is to measure pressure distribution and forces needed for tool production and use.

the study will measure pressures and forces for adl and simulated work using healthy volunteers. sixteen volunteers will be chosen over a range of ages but specifically include similar numbers of early adulthood (18-44), middle age (45-65), and elderly (\>65). sixteen volunteers from each age group divided evenly by gender will be selected. therefore, a total of 48 subjects will be tested, with an even number of male and female performing each of the activities listed above. inclusion critera volunteers will be recruited through website, personnel, and community contacts. they will be recruited based on age and gender. exclusion criteria patients will be excluded if they have a history of an inflammatory condition such as rheumatoid arthritis or lupus. they will be excluded if they have symptomatic osteoarthritis of their hands. additional exclusion criteria will include known neurologic conditions, or prior injury that may be contributing to weakness or atrophy.

Eligibility criteria:
inclusion criteria: * healthy volunteers * at least 18 years old * willing to participate in the study exclusion criteria: * history of an inflammatory condition such as rheumatoid arthritis or lupus * symptomatic osteoarthritis of their hands * known neurologic condition * prior injury that may be contributing to weakness or atrophy

Keywords: grip pinch forces pressure tekscan sensor adl activities of daily living work requirements hand biomechanics forceful precision grip power grip hominid hominin prehistoric
mutation of brca1/2 and other potential genes in triple-negative breast cancer

Conditions: Breast Cancer

Summary: the study is to determine the prevalence of potential chemo-response related genes mutation in tnbc patients between pcr and sd/pd group, which achieved after nac; and to evaluate potential relationship between these gene mutations and nac-response in tnbc patients.based on the results,we can further characterize tnbc from a phenotypical and molecular perspective, in order to identify potential new target agents and to individualize the treatment.

this is single centre，exploratory，parallel and retrospective study to analysis the mutation and expression of tbrca1/2 and other potential genes in triple-negative breast cancer. patients received neoadjuvant chemotherapy with paclitaxel and carboplation are enrolled in this study. the participants are required to have clinical stage ii or iii breast cancer with a clinical or radiographically measurable residual tumor after core biopsy. we will enroll the patients of pcr or sd/pd, which achieved after complete nac. every group will enroll 50 patients. this study is to identify relationship between different gene mutations and expression, which may be targeted with currently available investigational drugs, and chemo-response. patients who will fulfil all inclusion/exclusion criteria. we conducted a retrospective chart review of the 100 patients.

Eligibility criteria:
inclusion criteria: patients receiving neoadjuvant chemotherapy with paclitaxel and carboplation are enrolled in this study. * (1) histologically confirmed mainly invasive breast carcinoma * (2) a unilateral and non-inflammatory tumors * (3) status of er, pr and her-2 are available and negative * (4) the participants are required to have clinical stage ii or iii breast cancer with a clinical or radiographically measurable residual tumor after core biopsy. * (5)patients had pathological evaluation after nac * (6) the pathologic tissues are available for immunohistochemistry and next generation sequencing exclusion criteria: * (1) carcinoma in situ * (2) received less than 4 cycles neoadjuvant chemotherapy

Keywords: brca1/2;mutations;neoadjuvant chemotherapy;tnbc
study of the garft inhibitor ag2037 in patients with metastatic colorectal cancer who failed treatment

Conditions: Colorectal Neoplasms

Summary: to determine the response rate in patients with metastatic colorectal cancer who failed treatment with a 5-fluorouracil/leucovorin regimen and up to one other chemotherapeutic regimen (not including adjuvant chemotherapy).


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum * stage iv or recurrent disease * measurable disease * disease progression or recurrence during or after completion of prior first-line chemotherapy with fluorouracil and leucovorin calcium (5-fu/lv) * prior irinotecan or oxaliplatin as part of the 5-fu/lv regimen or as subsequent therapy allowed * only 2 prior regimens for metastatic disease allowed * one additional regimen as adjuvant therapy allowed provided patient remained disease-free for \> 6 months after completion of therapy\* * newer, targeted investigational agents (e.g., cetuximab or bevacizumab) are not counted as a chemotherapeutic regimen unless used in combination with a cytotoxic regimen note: \*if evidence of failure occurred within \< 6 months after completion of adjuvant therapy, patients may have received only 1 additional regimen for metastatic disease * no active brain metastases (requiring treatment or progressing) exclusion criteria: * history of blood transfusion within 14 days * need of concurrent administration of allopurinol * history of radiotherapy or chemotherapy within 4 weeks * any psychological or sociological condition, addidtive disorder or family problems that might preclude compliance with the protocol * any unstable or severe intercurrent medical condition that in the opinion of th einvestigator might interfere with achievement of study objectives * receipt of an investigational agent within 28 days prior to first day of dosing with ag-2037 * pregnant or breast feeding * previous treatment with garft inhibitors * history of a malignancy (other than colorectal cancer) excpet those treated with curative intent for skin cancer (other than melanoma) or in situ breast or cervical cancer or those treated with curative intent for any other cancer with no evidence of disease for 5 years * active brain metastases (requiring treatment or progression)