Kornimate/medical-research-clean huggingface dataset:
remote ischaemic conditioning for fatigue after stroke

Conditions: Stroke, Ischemic; Stroke Hemorrhagic; Fatigue

Summary: this is a pilot randomised control trial to assess the safety, compliance, and acceptability of delivering a 6-week programme of remote ischaemic conditioning (ric) to stroke patients suffering with fatigue, and study feasibility. a minimum of 34 patients who have suffered an ischeamic or haemorrhagic stroke and who suffer from fatigue, will be recruited and randomised to receive a 6-week programme of either ric or a sham intervention.

up to 75% of stroke patients suffer from fatigue, the effect of which can be physical, cognitive or emotional, and presents a large barrier to progressing rehabilitation. remote ischaemic conditioning (ric) is a procedure whereby ischaemia is induced to a limb for short periods of time by inflating pressure cuffs around arms or legs to above systolic pressures (mmhg). this procedure is performed for periods that avoid physical injury to the limbs, but induce neurohormonal, systemic or vascular changes in the body. such changes often result in improved collateralisation of blood supply to various areas of the body, as well as improved efficiencies of cellular metabolism. this may enhance the physical abilities of patients undergoing rehabilitation after stroke, particularly when aiming to improve endurance and fatigue.

Eligibility criteria:
inclusion criteria: * adults (aged \> 18 years) who have had an ischaemic or haemorrhagic stroke at least 6 weeks prior. * symptoms of debilitating fatigue for at least 4 weeks (fatigues severity score of 28 or more). exclusion criteria: * history or presence of significant peripheral vascular disease in the upper limbs. * history or presence of complex neuropathic pains or peripheral neuropathy in the arms. * presence of lymphoedema in the arms. * presence of skin ulceration to the arms. * hospitalisation for cardiovascular or cerebrovascular disease within the last 4 weeks. * uncontrolled arrhythmia, hypertension, diabetes or angina. * third degree heart block or progressive heart failure. * acute aortic dissection, myocarditis, or pericarditis. * acute deep vein thrombosis, pulmonary embolism or pulmonary infection. * suspected or known dissecting aneurysm. * uncontrolled visual or vestibular disturbance. * known or suspected cause of fatigue e.g. obstructive sleep apnoea (epworth \> 15), depression (phq-9 \> 14). * modified rankin score \> 4.

Keywords: remote ischaemic conditioning
efficacy in reducing fractures and safety of zoledronic acid in men with osteoporosis

Conditions: Male Osteoporosis

Summary: this study will investigate if the drug zoledronic acid given once yearly is safe and has beneficial effects in treating osteoporosis by reducing bone loss and fractures in men with osteoporosis.


Eligibility criteria:
inclusion criteria: • osteoporosis as defined by very low bone mineral density in the hip and spine or low bone mineral density in the hip combined with presence of 1-3 mild or moderate fractures of the vertebrae exclusion criteria: * low vitamin d * renal insufficiency * previous treatment with certain anti-osteoporotic therapies (except after certain washout periods): calcitonin, bisphosphonates, parathyroid hormone (pth), sodium fluoride, strontium ranelate, * previous treatment with testosterone, anabolic steroids or growth hormone * chronic use of systemic corticosteroids (oral or i.v.) within the last year * history of any cancer or metastases within the last 5 years * history of brittle bone disease, multiple myeloma, or paget's disease, or any other metabolic bone disease, except osteoporosis * bilateral hip replacements other protocol-defined inclusion/exclusion criteria may apply

Keywords: osteoporosis males vertebral fractures clinical fractures bone mineral density bone biomarkers zoledronic acid
immunotherapy with cd19 car γδt-cells for b-cell lymphoma, all and cll

Conditions: Leukemia; Lymphoma

Summary: this study aims to evaluate the safety, efficacy and duration of response of cd19 chimeric antigen receptor (car) redirected allogeneic γδt-cells in patients with high risk, relapsed cd19+ haematological malignancies.

this is a multi-centre, non-randomised, open label phase i clinical trial of an advanced therapy investigational medicinal product named cd19 chimeric antigen receptor (car) γδt-cells (cd19 car γδt-cells) in patients with high risk, relapsed cd19+ haematological malignancies (leukemia and lymphoma). following informed consent and registration to the trial, patients will receive the allogeneic cd19 car γδt-cells following lymphodepleting chemotherapy. the study will evaluate the safety, efficacy and duration of response of the cd19 car γδt-cells in patients with high risk relapsed cd19+ malignancies.

Eligibility criteria:
inclusion criteria: 1. relapsed or refractory b cell derived acute lymphoblastic leukemia(all), chronic lymphoblastic leukemia(cll) and non-hodgkin lymphoma. 2. kps\>60. 3. life expectancy\>3 months. 4. gender unlimited, age from 18 years to 70 years. 5. cd19 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry. 6. patients who have failed at least one line of a standard treatment. 7. no serious mental disorder. 8. patients must have adequate cardiac function(no cardiac disease, lvef≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of \>94%, and adequate renal function(cr≤133umol/l). 9. no other serious diseases(autoimmune disease, immunodeficiency etc.). 10. no other tumors. 11. patients volunteer to participate in the research. 12. patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active gvhd and no longer taking immunosuppressive agents for at least 30 days prior to infusion. exclusion criteria: 1. kps\<50. 2. patients are allergic to cytokines. 3. central nervous system leukemia within 28 days. 4. uncontrolled active infection. 5. acute or chronic gvhd. 6. treated with t cell inhibitor. 7. pregnancy and nursing females. 8. hiv/hbv/hcv infection. 9. other situations we think improper for the research.

Keywords: leukemia lymphoma car γδt
nab-paclitaxel plus camrelizumab and s-1 conversion therapy for gastric cancer with positive exfoliative cancer cells

Conditions: Gastric Cancer

Summary: the purpose of this study is to investigate the efficacy and safety of intraperitoneal and intravenous nab-paclitaxel plus camrelizumab and s-1 conversion therapy for gastric cancer with positive exfoliative cancer cells.


Eligibility criteria:
inclusion criteria: 1. none previous chemotherapy, radiotherapy and other antitumor therapy; 2. age:18 to 70 years old; 3. man or female (except pregnant and lactating women); 4. conﬁrmed to gastric adenocarcinoma and her2-negative; 5. proven gastric cancer of t stage was t3 and t4, and no distant metastasis was observed. the exfoliative cancer cells detection in peritoneal washes was positive; 6. blood cell count has to meet the following certeria: wbc≥3.5×109/l; anc≥1.5×109/l; plt≥100×109/l; hb≥90g/l; 7. liver/kidney function has to meet the following certeria: alt and ast≤2.5×uln tbil\<1.5×uln； serum creatinine ≤1.5×uln; 8. left ventricular ejection fraction (lvef) ≥50%; 9. eastern cooperative oncology group (ecog) performance status of 0-1; 10. participants were willing to join in this study, good adherence and written informed consent. exclusion criteria: 1. subjects with immunosuppressive medications within 14 days of first administration of study treatment, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroid hormones (no more than 10 mg / day of prednisolone or other corticosteroids of equivalent pharmaceutical physiological dose); 2. the patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; patients with vitiligo; asthma has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included; asthma patients who require bronchodilators for medical intervention cannot be included); 3. patients with other malignant tumors within 5 years; 4. human immunodeficiency virus (hiv) infection or acquired immunodeficiency syndrome (aids), active hepatitis b (hbv-dna ≥1000 iu/ml) or hepatitis c (positive hepatitis c antibody, and hcv-rna is higher than the lower limit of detection of the analytical method) or co-infection with hepatitis b and c, requiring antiviral treatment during the study; 5. distant metastasis; 6. it has serious or uncontrolled medical diseases and infections (including atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction less than 50%, poor-controlled hypertension and so on); 7. history of psychiatric drugs abuse and can't quit or patients with mental disorders; 8. patients with severe or uncontrollable mental illness; 9. it have serious harm to the patient's safety or affect the patients who have completed the research. 10. the researchers think inappropriate.
fish oil supplementation in gastrointestinal cancer

Conditions: Gastrointestinal Cancer; Colorectal Cancer; Stomach Cancer

Summary: double-blind, randomized clinical trial to assess the effects of 1,55 g/day of n-3 fatty acids from fish oil concomitant chemotherapy in gastrointestinal cancer.

this study will be divided into three stages defined as: baseline (t0), middle moment (t1) and final moment (t2). at baseline, will be performer the patients identification, clinical data collection, assessment of anthropometric data and body composition, blood sample collection and questionnaires application for individuals allocated into two groups (fish oil group and placebo group). the fish oil group (gop) will receive fish oil capsules and the placebo group (gp) will receive capsules containing olive oil, both also will receive consumption guidelines. the list of randomization was generated by a computer program and was divided by cancer localization and gender. the researchers involved with the recruitment had access only to randomization list containing codes. the codes were distributed sequentially. the baseline is the day of first chemotherapy. in the middle moment, five weeks after the start of study, new blood collection, questionnaires and measurement of anthropometric data will be performed. at the final moment, nine weeks after baseline, last blood collection, questionnaires and measurement of anthropometric data and body composition of fish oil and placebo groups will be performed, and will feature the end of the capsules consumption. after 6 months and 1 year after the initiation of chemotherapy and supplementation with fish oil or placebo, survival data will be collected. throughout the monitoring period, the researcher and collaborators will maintain contact with the individuals included. the contact will be made in cepon, where they receive chemotherapy, and by telephone.

Eligibility criteria:
inclusion criteria: * individuals with age between 18 to 70 y. * histopathological diagnosis of gastric cancer, or colorectal or anal canal or intestinal cancer * ability to start chemotherapy in institution (cepon) * performance status \<= 2 exclusion criteria: * prior chemotherapy * inability to oral intake * diagnosis of infectious or inflammatory disease or diabetes * allergy to fish and / or derivatives, * pregnant, * treatment with statins or anti-inflammatories drugs * intake of fish oil and/or another supplement containing omega-3 or other polyunsaturated fatty acid in the six months prior their inclusion in the study * continued use of supplements containing antioxidants * patients in palliative care * without cognitive ability to perform the study protocol * enrolled in studies with new drugs * hospitalized patients at recruitment

Keywords: gastrointestinal cancer fish oil oxidative stress inflammation quality of life nutritional status colorectal cancer stomach cancer chemotherapy polyunsaturated fatty acids n-3
efficacy and safety of oral salmon calcitonin in patients with knee osteoarthritis (oa 2 study)

Conditions: Osteoarthritis

Summary: the purpose of this phase iii study is to evaluate the efficacy and safety of oral salmon calcitonin in the treatment of patients with osteoarthritis of the knee


Eligibility criteria:
inclusion criteria: * medical history and symptoms of knee osteoarthritis exclusion criteria: * any other disease or medication affecting the bone or cartilage. * any clinical signs or laboratory evidence diseases, which in the investigator's opinion would preclude the participant from adhering to the protocol or completing the trial. other protocol defined inclusion/exclusion criteria may apply

Keywords: osteoarthritis, oral salmon calcitonin, treatment, efficacy, tolerability
guideline for hometitration with duodopa for parkinson patients

Conditions: Parkinson Disease

Summary: the purpose of this study is to 1. create a guide for hometitration of duodopa for patients with parkinson's disease 2. outline which patients could be considered for "hometitration"

to start treatment with continuous intestinal levodopa infusion to the duodenum (duodopa-pump) in patients with idiopathic parkinson disease (ipd), it is usually required that the patient is hospitalised to test if duodopa works for the patient and for the titration process to find the relevant dosage before operation and connection of the pump. a hospitalisation is very costly. experience shows, that this group of patients are often very stressed during hospitalisation because of noise, impaired sleep and unfamiliar surroundings. these conditions make fast and effective dosage titration very difficult, and experience also shows that the dosage often needs to be recalibrated once the patient is back home in familiar surroundings. the use of telemedicin (tm) is on the rise in denmark as well as other international health care systems. these factors were the basis for the home-titration study where patients have their initial dosage titration done in their own home, supported by one visit from nursing staff, and one tm (video consultation) a day. the goal is to make the titration process more effective, reduce cost by treating the patient in their own home and making the patient more satisfied with the titration process.

Eligibility criteria:
inclusion criteria: * idiopathic parkinson disease (uk parkinson's disease society brain bank criteria-uk pdsbb) * patient must be self-sufficient, or have access to support in own home (spouse, nursing home, home-nurse) * motivated and comfortable with home treatment and telemedicine (tablet provided by the clinic) exclusion criteria: * patients not eligible for duodopa-treatment

Keywords: parkinson disease duodopa pump tele-medicine
haemostasis and tranexamic acid in caesarean delivery

Conditions: Postpartum Hemorrhage; Hyperfibrinolysis

Summary: the aim of the study is to evaluate haemostasis and fibrinolysis in peripartum of caesarean delivery and the effect of tranexamic acid (txa) given in prevention of post-partum haemorrhage (pph).

post-partum haemorrhage (pph) remains a leading cause of maternal morbidity and mortality. haemostasis and fibrinolysis are activated in peripartum. fibrinolysis is decreased during pregnancy, is quickly activated after childbirth and can be overactivated in case of pph. tranexamic acid (txa), an antifibrinolytic drug, has been proven to efficiently decrease bleeding and death in pph. its place in prevention of pph after caesarean section remains to be established. the aim of the study protocol traap2 is to conduct a large multicentre randomized, double blind placebo-controlled trial to adequately assess the impact of txa for preventing pph following a caesarean section. peripartum is also a period of increased thrombo-embolic risk. txa has never been proven to increase thromboembolic events. nevertheless, it seems important to reserve txa for women with activated fibrinolysis. the aim of the ancillary biologic study bio-traap is thus to explore haemostasis and fibrinolysis in peripartum, to determine which women will in the future benefit from txa. fibrinolysis will be studied by clot lysis time by global fibrinolytic capacity test on the lysis timer (gfc/lt), t-pa, pai-1, pai-2, euglobulin clot lysis time, plasminogen, plasmin-anti-plasmin complex, thrombin-anti-thrombin complex, fibrin degradation products (fdp).

Eligibility criteria:
inclusion criteria: * patient randomized into traap2 study (nct03431805): * adult women admitted for a planned caesarean delivery, * at term ≥ 34 weeks, * haemoglobin level at the last blood sample \>9g/dl, * blood formula numbering within 7 days before caesarean delivery, informed signed consent) * informed signed consent for bio-traap exclusion criteria: * patient not included into traap2 study: * previous thrombotic event or pre-existing pro-thrombotic disease, * epileptic state or history of seizures, * presence of any chronic or active cardiovascular disease outside hypertension, * any chronic or active renal disease including renal, chronic or acute insufficiency (glomerular flow \<90ml / min), and chronic or active liver disease at risk thrombotic or haemorrhagic, * autoimmune disease, * sickle cell disease, * placenta praevia, * placenta accreta/increta/percreta, * abruption placentae, * eclampsia, * hellp syndrome, * in utero fetal death, * administration of low-molecular-weight heparin or antiplatelet agents during the week before delivery, * general anaesthesia, * hypersensitivity to tranexamic acid or concentrated hydrochloric acid, instrumental extraction failure, * multiple pregnancy with genital delivery of the first twin and caesarean delivery for the second or at third trimester, * poor understanding of the french language

Keywords: ancillary biologic study fibrinolysis tranexamic acid post-partum haemorrhage
comparison of tcm and laxatives for adults with chronic constipation

Conditions: Chronic Constipation

Summary: the purpose of the study is to compare the therapeutic efficacy, safety, cost-effectiveness and maintenance effect between chinese herbal formula and lactulose on chronic constipation in long-term care.

although many people regard regular defecation as important factor to maintain healthy, constipation is still a common problem in general population. according to some surveys, constipation affects approximately 50% to 73% of nursing home residents. because the symptoms cause serious impairment of life quality, laxatives are commonly prescribed for people and over-prescribing of laxatives is also common. despite the large sums spent on laxatives, there have been few advances in laxative treatment in the last 50 years and there have been minimal research addressing the problem. therefore constipation was labeled as "the neglected symptoms". there is unsatisfactory effect by currently pharmacologic therapies and preventive strategies for constipation. contrarily, they had abundant clinical experiences and medical records for constipation in traditional chinese medicine. so we follow the worldly trend to do the research of integrative chinese medicine and western medicine since who launched the first global strategy on traditional and complementary/alternative medicine (tm/cam) to assist countries to create a stronger evidence base of the tm/cam products and practices. the study will be performed under randomized, double-blind, placebo controlled, parallel design. the object of this study is the residents in nursing homes. after intake of chinese herb, improving constipation and care quality, decreasing the need of enema or digital maneuver, minimizing the dosage of rescue laxatives and saving the medical expenditure will be expected.

Eligibility criteria:
inclusion criteria: * men and non-pregnant women who are at least 20 years of age * patients who have been adequately informed of the nature and risks of the study and who have given written informed consent prior to receiving study medication * the one who meet any one of the following three criteria: 1.romeiii criteria; 2.at least once a week of enema/suppository use/digital maneuver in past three months; 3.laxative use in more than half time of last three months exclusion criteria: * known severe renal or hepatic insufficiency, * known colorectal cancer, anal abscess, anal fistula, anal fissure, rectocele, inflammatory bowel diseases, or gastrointestinal obstruction; * unknown cause of gastrointestinal bleeding or acute infection * neuromuscular dystrophy or spinal cord injury induced constipation * history of drug abuser * unstable psychiatric disorders * women who are pregnant, as determined by a urine pregnancy test * use of an investigational drug (within 30days prior to enrolled) * known allergies to the component of study medication

Keywords: constipation traditional chinese medicine chinese herbal formula lactulose cost-effective long-term care
learning through play (ltp) plus intervention for depressed fathers (ltp plus dads)

Conditions: Depression

Summary: the aim of the study is to evaluate the clinical and cost effectiveness of culturally adapted group parenting intervention delivered by non-specialists and community health workers for depressed fathers.

most research on the association between parental depression and child outcomes has focused mainly on mothers. however, studies suggest that the relationship between parental depression and child outcome is not necessarily limited to mothers. the study has two phases quantitative and qualitative: purpose of this quantitative phase is to determine if the ltp plus programme delivered by non-specialists and community health workers reduces symptoms of paternal depression and improves child development compared to treatment as usual. in the qualitative part of the study focus groups and in-depth digitally recorded interviews will be conducted with participants by trained research staff at two-time points both before and after the intervention. these focus groups and in-depth interviews will continue till the data saturation is achieved. in addition, participants who refused to participate in the trial will be asked if they would be willing to be contacted by a researcher to discuss their reasons for not taking part. moreover, in-depth digitally-recorded interviews with stakeholders (grandparents, therapists, health professionals, etc) will also be conducted by trained researchers.

Eligibility criteria:
inclusion criteria: * 18 to 55 years old fathers * having children aged between 0-30 months * diagnosis of major depressive disorder using the structure clinical interview for dsm-v, * ability to complete a baseline assessment. * given written informed consent exclusion criteria: * any medical illness that will prevent them from participation in the clinical trial, * current or past diagnosis of bipolar depression * currently using antidepressants or receiving any kind of psychotherapy * active suicidal ideation, * any other severe physical or mental disorders

Keywords: learning through play plus cognitive behavior therapy parenting intervention low and middle-income country