Kornimate/medical-research-clean huggingface dataset:
colombes project:constitution of a population-based cohort of obese subjects with longitudinal long-term follow-up

Conditions: Obesity

Summary: the objective of the project is the constitution of a population-based cohort of 500 persons with severe or morbid obesity (bmi over 35 kg/m2) with annual follow-up for 10 years. it aims to improve the physiopathological, epidemiological and prognostic knowledge of obesity and its consequences. clinical data, biological material, exams and questionaires will be collected and stored, allowing the realisation of research works, initiated by research teams from our hospital or from other settings.

the objective of this observational study is the follow-up of a cohort of 500 adult persons with morbid obesity (bmi\>35 kg/m2). clinical and paraclinical data, and biological samples (plasma, serum, dna, rna, cell blood, for persons undergoing bariatric surgery (specific consent): samples of liver and adipocytes) will be collected and stored during the follow-up visits. these visits take place at inclusion, at 6 months, twelve months and every year for ten years. the collection of parental dna will be proposed when feasable for genetic studies. persons will be recruited for four years, with an expected number of 350 persons included, in the clinical research unit of louis mourier university hospital (ap-hp). each person included will participate in the study for ten years. when included, patients agree to come every year to follow-up visits. they are informed that data collected will be used only for research on obesity and its health consequences.

Eligibility criteria:
inclusion criteria: * bmi\>35 exclusion criteria: * previous bariatric surgery * pregnancy

Keywords: obesity cohort
study evaluating the benefit of music therapy on pruritus in patients with pruritic dermatitis

Conditions: Pruritus

Summary: many clinical studies have shown the benefit of music therapy in various pathologies, including pain, and it is now established that the latter has a complementary therapeutic interest. its most frequently identified indications are the fight against acute or chronic pains, the reduction of anxiety, depression and stress, as well as memory disorders such as alzheimer's disease. the main modes of action of music therapy involve sensory, cognitive, psychological and behavioral processes that are also found in pruritus. pruritus is defined as "an uncomfortable sensation causing the need to scratch. it has similarities with pain but also differences: relief by heat / cold, scratching / withdrawal behavior, localization on the skin, semi-mucous / ubiquitous ... etc. the pathophysiology also has similarities, pruritus is born at the dermal-epidermal junction at the level of specific cutaneous receptors then follows the classical pathways through a 1st neuron, then the dorsal horn of the spinal cord and a second neuron. at the cerebral level, there is no single center of pruritus but several motor and sensory areas involved. the similarities suggest that music therapy may have an interest in the management of chronic pruritus, especially since classical treatments (antihistamines, topical corticosteroids) have only partial efficacy in some dermatoses


Eligibility criteria:
inclusion criteria: * at least 18 years of age * patient with pruritic dermatosis whatever the etiology (psoriasis, atopic dermatitis, toxiderma, cutaneous lymphoma, chronic urticaria ...) * hospitalized in continuous hospitalization in the dermatology department * age of dermatosis ≥ 1 month * pruritus score ≥ 3/10 by numerical evaluation * patient having signed a consent form exclusion criteria: * patient under the age of 18 * major impairment of hearing function * presence of major cognitive disorders * refusal to participate * pregnant or lactating women * institutionalized or emergency patients * patient under legal protection regime * patient not affiliated to the social security system
safety and efficacy study of mguard stent after a heart attack

Conditions: Myocardial Infarction

Summary: the goal of this study is to demonstrate the superiority of the mguard™ stent over commercially-approved bare-metal (bms) /drug-eluting stents (des) in achieving better myocardial reperfusion in primary angioplasty for the treatment of acute st-elevation myocardial infarction (stemi).


Eligibility criteria:
inclusion criteria * 18 years of age * st-segment elevation (more than 2mm in more than contiguous leads) * mi with symptom onset less than 12h * the patient is willing to comply with specified follow-up evaluations * signed icf * single de novo lesion in the target (culprit) vessel * target lesion maximum length is 33 mm (by visual estimation) * reference vessel diameter must be more than 3.0 to less than 4.0 mm by visual estimation * randomization should occur as soon as presence of timi 2 or 3 before randomization exclusion criteria * pregnant or nursing patients * left bundle branch block (lbbb), paced rhythm, or other electrocardiogram (ecg) abnormality * impaired renal function * prior coronary artery bypass graft surgery * bleeding diathesis * contraindication to aspirin * cardiopulmonary resuscitation * cardiogenic shock * chronic warfarin anticoagulation * lvef less than 20% * other medical illness * participation in another investigational drug or device study that has not reached its primary endpoint * left main coronary artery disease with 50% stenosis * ostial target lesion * failure to visualize vessel anatomy distal to the culprit lesion * moderate to heavily calcified target lesion or vessel * excessive tortuosity * bifurcation with a side branch more than 2.0 mm in diameter * a significant (greater than 50%) stenosis proximal or distal to the target lesion is present that cannot be covered by same single stent * diffuse disease distal to target lesion with impaired runoff * any prior stent proximal to the target lesion, or within 10 mm distal of the target lesion * pci of another lesion performed within 6 months before the index procedure * target lesion located in a saphenous vein graft

Keywords: stemi myocardial infarction stent
assessment of oral and nasal breathing with sensors analyzing algorithm

Conditions: Nasal Polyps; Asthma; COPD; Allergic Rhinitis

Summary: the goal of this observational study is to learn about the agreement between sensors analyzing algorithm and body plethysmography in measuring oral and nasal breathing in healthy adults, and in patients with chronic rhinosinusitis, asthma and chronic obstructive pulmonary disease. the main question it aims to answer is: • is the algorithm-based method accurate enough in analyzing respiratory obstruction as compared to body plethysmography (reference method)? participants will perform a short breathing protocol (oral and nasal breathing with different masks) during which time their breathing is monitored with both methods.

the data collected in the patient registry include: parameters on general health, like previous illnesses, medications, height, weight, answers to symptoms queries and queries on quality of life (asthma test, copd test, sinonasal outcome test 22) as well as results from the examined medical devices (body plethysmography, spirometry, sensors analyzing algorithm).

Eligibility criteria:
inclusion criteria: * 5 healthy and asymptomatic volunteers with regard to lungs and nose * 5 patients with allergic rhinitis or nasal polyps (diagnosis of allergic rhinitis confirmed by a prick test or specific ig e antibody tests and nasal polyposis diagnosed by an ent specialist, with endoscopy) * 5 patients with asthma (diagnosis of asthma based on peak expiratory flow (pef) monitoring, spirometry, or other appropriate objective measurement methods performed by a pulmonologist * 5 patients with chronic obstructive pumonary disease (diagnosis of copd based on spirometry (post-bronchodilator forced expiratory volume/ forced vital capacity (fev1/fvc) ratio below 0.70) exclusion criteria: * pregnancy. * history of surgical procedures in the chest, larynx, throat (excluding tonsillectomy), or nasal area. * recent illnesses or surgeries that pose a risk to the patient or prevent proper measurement (common contraindications for spirometry): * recent (\<1 month) myocardial infarction. * severe coronary artery disease with easily triggered symptoms. * cerebral artery aneurysm. * recent brain (\<4 weeks) or eye (\<1 week) surgery. * severe cardiac arrhythmias. * pulmonary tuberculosis. * pneumothorax * immediate postoperative period of lung surgery (\<1 day). * dementia or confusion.
cerebrovascular correlates of dementia in rural communities - the three villages study

Conditions: Dementia; Cardiovascular Risk Factor; Atherosclerosis; Cerebral Small Vessel Diseases; Cognitive Decline

Summary: this study aims to assess the prevalence and severity of dementia in an established cohort of community-dwelling older adults living in three neighboring rural ecuadorian villages (atahualpa, el tambo, and prosperidad), as well as to evaluate clinical and neuroimaging correlates of dementia in the study population. by the use of the clinical dementia rating scale (cdrs), the study also aims to assess the lower cutoff of the moca that better correlates with the occurrence of dementia in the study population. in addition, this study will provides grounds for the initiation of a prospective cohort study to assess factors influencing the development of dementia in the follow-up.

the three villages study is a population-based prospective cohort study designed to reduce the increasing burden of cognitive decline and dementia in rural ecuador. before the study, our executive committee met with community leaders to explain the aims of the study and to learn about the culture and traditions of villagers. field personnel were trained to assure uniformity in data collection. with the aid of satellite view (google earth, google inc., mountain view, ca), updated sketches of the villages were performed to identify blocks and houses. the study initially will follow a 3-phase cross-sectional design. during phase i, atahualpa, el tambo, and prosperidad residents aged 60 years or more will be identified by means of a door-to-door survey and interviewed with validated questionnaires to identify those with relevant risk factors and suspected conditions of interest. in phase ii, certified neurologists will examine suspected cases as well as random samples of negative individuals, to assess reliability of field instruments and to determine prevalence of the investigated conditions. in phase iii, enrolled individuals will be invited to undergo complementary tests. thereafter, incoming residents will be recruited and followed-up by means of yearly door-to-door surveys and other overlapping sources to estimate incidence of the disorders of interest.

Eligibility criteria:
inclusion criteria: individuals aged 60 years of more residing in atahualpa, el tambo, and prosperidad, who signed a comprehensive informed consent form. - exclusion criteria: severely disabled individuals in whom interviews and procedures cannot be performed -

Keywords: dementia cognitive performance vascular diseases rural ecuador atahualpa el tambo prosperidad three villages study
clinical pharmacology study of ts-143 in nondialysis and hemodialysis patients with chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: to evaluate the safety, pharmacokinetics, and pharmacodynamics in nondialysis (nd) and hemodialysis (hd) subjects with chronic kidney disease (ckd) who receive a single administration of ts-143.


Eligibility criteria:
inclusion criteria: * serum concentration of erythropoietin (epo): \<50 miu/ml at screening test 1, 2, or 3 * transferrin saturation ≥ 20% or ferritin ≥ 100 ng/ml at screening test 1 * subjects meeting any of the following criteria 1. subjects who has not used erythropoiesis-stimulating agent (esa) ≥ eight weeks from screening test 1 2. subjects who has used esa, other than epoetin beta pegol, ≥ four weeks from screening test 1 and has met all of the following criteria a) to c). a)the total esa dosage for each week could be changed within a range of 50%, compared to the total esa dosage for one week before screening test 1, for four weeks before screening test 1 b)acceptable to discontinue esa the day following screening test 1 to follow-up 2 c)the fluctuating range of hb concentration between screening tests 1 and 2 is within ±0.5 g/dl per week (the same criteria applied between screening test 2 and 3) * subjects who receive an explanation about the study before participating in the study and can understand the contents and are willing and able to provide written consent. \ * ckd subjects who never received dialysis and do not need to receive dialysis during the study period. * subjects with an hb concentration at screening test 1 (esa present at screening test 2) ≥ 10.0 g/dl to \< 13.0 g/dl. * subjects with an egfr at screening test 1 ≥ 15 ml/min/1.73m\^2 to \< 45 ml/min/1.73m\^2. \ * subjects who received hemodialysis (including diafiltration) three times per week ≥ 12 weeks from acquisition consent. * subjects with an hb concentration at screening test 1 (esa present at screening test 2) ≥ 10.0 g/dl to \< 12.0 g/dl. exclusion criteria: * subjects with anemia other than that caused by ckd. * subjects who have severe infection, systemic hematopathy (e.g. myelodysplastic syndrome, hemoglobinopathy), peptic ulcer or clear hemorrhagic lesion such as gastrointestinal hemorrhage * subjects with immune disorder with severe inflammation * subjects with uncontrolled secondary hyperparathyroidism * subjects who already had or will have a kidney transplantation * subjects who have a complication which requires treatment such as proliferative retinopathy, macular edema, or macular degeneration. or, subjects who had a complication which required treatment such as proliferative retinopathy, macular edema, or macular degeneration within 12 months from screening test 1 * subjects with congestive heart failure * subjects with a medical history of thrombotic disease in the six months from screening test 1 * subjects with uncontrolled blood pressure; sbp \> 170 mmhg or dbp \> 100 mmhg at screening test 1 (esa present, screening tests 1 and 2), (hd subject, evaluated before dialysis)

Keywords: dialysis, ckd
study to optimize insulin treatment by basal regimen with insulin glargine in type-2-diabetic patients previously uncontrolled on premixed insulin

Conditions: Diabetes Mellitus, Type 2

Summary: primary objective: to show an improvement in hba1c control after 4 months of treatment with insulin glargine + oral anti diabetic (oad) in patients previously uncontrolled on premixed insulin (with oad) secondary objective: improvement of fasting blood glucose (fpg) after 4 months treatment (% of patients treated to target hba1c ≤7.0% and/or fbg≤6.0mmol/l). frequency of hypoglycemic episodes, quality of life with basal+ oad regimen.


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus inadequately controlled at least 3 months on premixed insulin with 1 or 2 oads * 7.5 ≤ hba1c ≤ 9.5% * fpg ≥6.7 mmol/l * history of diabetes mellitus ≤10 years * premix insulin daily dosage ≤ 50 iu/day exclusion criteria: * type 1 diabetes mellitus * former treated on tzd * pregnancy / lactation * creatine ≥1.5 mg/dl * hepatic disease, jaundice,or alt/ast≥ 2.5 times of normal range * hormone therapy, * acute status of diabetes complications * severe concomitant disease or complications with high risk of unexpected fatal events, like myocardial infarct, stroke, heart failure. * allergic to insulin glargine or any ingredient * participation in another clinical trial within 3 months the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
transcranial magnetic stimulation (rtms) accelerates the response to escitalopram in major depression

Conditions: Major Depression

Summary: a doubleblind randomised trial with active versus sham rtms in combination with escitalopram in patients with prior treatment resistant depression in an acute 12 weeks trial with subsequent 24 weeks study phase with active versus placebo citalopram

in this study we aimed at investigating to what degree rtms applied over the left dorsolateral cortex relieves depressive symptoms when the treament is combined with antidepressive medication. the study will also be able to supply knowledge on how long any possible effect of the rtms treatment lasts. in the first 12 weeks of the trial participants are randomised to either rtms combined with escitalopram or sham rtms combined with escitalopram. rtms is given daily for the first 3 weeks. the next phase is a relapse prevention study where the responders from the initial phase are randomised to either active or placebo escitalopram for 24 weeks.

Eligibility criteria:
inclusion criteria: * major depression hamilton score above 18 * age 18 to 75 exclusion criteria: * pregnancy og breastfeeding * mental retardation and organic brain disease * alcohol and substance abuse * metal implants in brain, pacemakers and other electronic implants

Keywords: transcranial magnetic stimulation (tms) major depression treatment resistant major depression
liposomal bupivacaine for pain control after total shoulder arthroplasty

Conditions: Osteoarthritis; Arthropathy; Shoulder Pain; Closed Fracture Proximal Humerus, Four Part

Summary: this study will compare interscalene nerve block versus liposomal bupivacaine (exparel) for pain control after total shoulder replacements. each method will be assessed in terms of post operative pain scores, pain medication consumption, length of stay, complications (nerve injuries, hematomas, cardiac/respiratory events) and rate of readmission due to pain. the aims of this study will be achieved through a randomized controlled trial and cost-effectiveness analysis.

after the decision to proceed with shoulder replacement surgery, patients will be asked to participate in this randomized trial. consent will be completed after explanation of each treatment group and the data to be collected. patients will be randomized into one of the two treatment groups by simple randomization into one of two groups: group 1 will receive interscalene nerve block and group 2 will receive liposomal bupivacaine for postoperative analgesia. randomization will be stratified by site. the surgeon at each site will be trained prior to enrollment on the correct way to perform exparel injections intraoperatively. patients in the interscalene nerve block group will be given a single shot block in the preoperative area by a fellowship-trained anesthesiologist. the primary outcome is pain score on a visual analog scale (vas) at 24 hours postoperatively. vas pain scores range from 0 (no pain) to 10 (unbearable pain). secondary outcomes are postoperative vas pain scores at 6, 12, 18, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 hours; vas pain score at the first postoperative visit ; intraoperative opioid consumption; postoperative opioid consumption at days 1, 2, 3, and 4; total opioid consumption at day 1 (intraoperative + postoperative day 1); duration of stay in the post-anesthesia care unit (pacu); duration of hospital stay; and vas score for satisfaction with pain control in the hospital and at home, assessed at participants' first postoperative visit. vas satisfaction scores range from 0 (not satisfied) to 10 (completely satisfied).

Eligibility criteria:
inclusion criteria: * degenerative changes of the shoulder joint (documented by radiographs) in patients planning total joint replacement with one of the study's four fellowship-trained orthopaedic surgeons. * patients who require revision surgeries, hemiarthroplasties, or who have chronic pain issues will be included. exclusion criteria: * allergy to liposomal bupivacaine * contraindications to the interscalene nerve block such as: * preexisting neurologic defects * local anesthetic allergy * coagulopathy * contralateral phrenic nerve dysfunction * severe chronic obstructive pulmonary disease
treatment of transfusion-dependent nonsevere aplastic anemia with luspatercept: a multicenter prospective clinical study

Conditions: Transfusion-dependent Non-severe Aplastic Anemia

Summary: the goal of this clinical trial is to learn whether luspatercept alone or in combination with deferasirox can promote hematopoietic function in patients with transfusion-dependent non-severe aplastic anemia, as well as to assess the safety and efficacy of this treatment approach. the main questions it aims to answer is: whether the combination therapy of luspatercept and deferasirox can improve hemoglobin levels in these patients. participants will receive luspatercept every 3 to 5 weeks based on hemoglobin response, undergo complete blood counts every 1 to 3 weeks, and receive other necessary evaluations as required.


Eligibility criteria:
inclusion criteria: * 1.age \>= 18 years; 2.according to the "chinese guidelines for the diagnosis and treatment of aplastic anemia (2022 edition)", the patient must be diagnosed with transfusion-dependent non-severe aplastic anemia (td-nsaa) and meet the requirement of erythroid hyperplasia in bone marrow aspiration from the posterior iliac crest and/or sternum being more than 15%; 3.if not newly diagnosed with td-nsaa, and there are combined primary disease maintenance medications, the following conditions must be met: 1. the patient has not received and does not consider hsct or atg treatment for at least the next six months; 2. if maintaining oral immunosuppressive therapy, the course must be at least 6 months and assessed as ineffective; 3. if maintaining androgen therapy, the course must be at least 3 months and assessed as ineffective; 4. if maintaining recombinant human erythropoietin therapy, the course must be at least 3 months and assessed as ineffective; 5. if maintaining thrombopoietin receptor agonist (tpo-ra) therapy, the duration must be \>=6 months with confirmed inefficacy, and a washout period of \>=1 month is required before study enrollment; 6. if the above maintenance medication durations are not met, a washout period of at least 1 month is required; 4.serum ferritin level \>= 1000 ng/ml; 5.complete whole exome sequencing and mds/aa next-generation sequencing testing are required. exclusion criteria: * 1. severe hepatic dysfunction (alt or ast ≥ 3 × uln); 2.severe renal impairment (egfr \ 1%; 6.patients planning to become pregnant or who are pregnant; 7.surgical or clinical conditions that may significantly alter drug absorption, distribution, metabolism, or excretion (e.g., gastritis, ulcers, history of gastrointestinal or rectal bleeding; history of major gastrointestinal surgery); 8.patients carrying congenital bone marrow failure-related gene mutations (homozygous or heterozygous, regardless of whether they are pathogenic/benign/likely benign/ of uncertain significance).