Kornimate/medical-research-clean huggingface dataset:
efficacy of hypnosis on pain and anxiety during lumbar puncture for etiological diagnosis of cognitive impairment

Conditions: Cognitive Impairment; Alzheimer's Disease

Summary: lumbar puncture is a diagnostic procedure performed as part of the etiological assessment of cognitive disorders. despite good tolerance and very rare complications, lumbar puncture is still perceived as being painful or anxiety-provoking by patients. hypnosis could improve pain and anxiety when performing lumbar puncture.

lumbar puncture is an invasive procedure potentially inducing pain and anxiety indicated in elderly patients for cognitive assessment. indeed, the measure of amyloid biomarkers and tau in the cerebrospinal fluid is useful in the etiological diagnosis of cognitive disorders. with the ageing of the population and the increase incidence of cognitive disorders, this diagnostic procedure will be more and more frequent. many studies have shown the efficiency of hypnosis during invasive procedure, especially in young children. the absence of side-effect is a major asset in elderly patients at high iatrogenic risk. it represents an interesting alternative to anxiolytic or sedative treatments. nevertheless, its effectiveness in the elderly during lumbar puncture remains to be demonstrated. investigators hypothesized that hypnosis may decrease pain and anxiety during lumbar puncture associated to setting comfort situation (relational care, music, transcutaneous anesthesia).

Eligibility criteria:
inclusion criteria: * age ≥ 70 years old * indication for a lumbar puncture for etiological diagnosis of cognitive impairment * understanding french language * written and informed consent for this study signed by the patient * affiliated to health insurance exclusion criteria: * mms\< 17 or cognitive impairment not allowing informed consent * contraindication to lumbar puncture * refusal to sign the written and informed consent * patient deprived of freedom by court or administrative order

Keywords: hypnosis lumbar puncture cognitive impairment alzheimer's disease cerebrospinal fluid
early-start antiplatelet treatment after neurosurgery in patients with spontaneous intracerebral hemorrhage

Conditions: Spontaneous Intracerebral Hemorrhage

Summary: this study is a multicenter, prospective, open-label, endpoint-blind, randomized controlled study.patients receiving surgical treatment for sich were divided into groups using the random machine method. in addition to conventional treatment for spontaneous intracerebral hemorrhage, patients in the group of early initiation of antiplatelet therapy were given conventional dose of aspirin (100mg, qd) antiplatelet therapy starting from the 3rd day after surgery.an independent group of investigators evaluated cardiac, cerebral and peripheral vascular events and bleeding events at four different time points.to evaluate the benefits and safety of early postoperative initiation of antiplatelet therapy in patients with spontaneous intracerebral hemorrhage.


Eligibility criteria:
inclusion criteria: * 18-70 years old. * nontraumatic spontaneous intracerebral hemorrhage. * postoperative patients with high risk of maccpe:(1)previous history of cerebral infarction or tia. (2)previous history of coronary heart disease or myocardial infarction.(3) use ascvd risk estimator plus（http://tools.acc.org/ascvd-risk-estimator-plus/#!/calculate/estimate/） to assess the risk of ischemic events for patients with no previous history of cerebral infarction, tia, or coronary heart diseases or myocardial infarction,10 years risk\>10% is defined as a high risk of cardiovascular ischemic events(4)the caprini risk scale is used to assess the risk of venous thrombosis in the lower extremities.score\>2 is defined as a high risk of venous thrombosis. * patients who received neurosurgical procedures to remove the hematoma, including craniotomy, endoscopic hematoma removal and hematoma aspiration. * patients who signed informed consent. * no history of allergy to salicylic acid preparation. * patients who complete the preintervention assessment and meet the fellow criteria:(1)postoperative head ct showed no new infarction or hemorrhage(2)postoperative venous ultrasound of the lower extremity did not reveal deep vein thrombosis.(3)postoperative electrocardiogram and myocardial enzyme examination did not show acute myocardial ischemia or myocardial infarction. exclusion criteria: * there are structural cerebrovascular lesions (such as intracranial aneurysms, cerebrovascular malformations, etc.) or tumors in the area of bleeding or the bleeding is suspected to be related to these lesions. * ischemic stroke with hemorrhagic conversion. * secondary bleeding due to venous embolism. * the malignant tumor is expected to have a survival of no more than 3 months. * take antithrombotic agents((vitamin k antagonists (warfarin) new anticoagulants(dabigatun rivaroxaban))) in addition to antiplatelet agents. * previous history of thrombocytopenia or coagulation disorders. * previous history of atrial fibrillation.

Keywords: antiplatelet treatment spontaneous intracerebral hemorrhage early-start neurosurgery
posterior sub-tenon's avastin

Conditions: Diffuse Diabetic Macular Edema

Summary: posterior sub-tenon's injection of bevacizumab decreased diffuse diabetic macular edema


Eligibility criteria:
inclusion criteria: patients with diffuse diabetic macular edema non-proliferative diabetic retinopathy maculat thickness ≥250 μ bcva ≥ 20/400 without any treatment

Keywords: diffuse diabetic macular edema sub-tenon bevacizumab
effects of non-invasive ventilation therapies on the lung in hypoxemic chest trauma patients

Conditions: Lung Trauma; Lung Contusion

Summary: chest trauma is common in traumatology. its management is based on ventilatory therapies, among which non-invasive ventilation (niv) is commonly used. some studies have shown the benefit of this therapy in hypoxemic patients, avoiding intubation, reducing length of stay and healthcare costs, and even reducing mortality. however, these studies are old and underpowered. high flow oxygen therapy (hfo), which is frequently used in everyday practice, has only one study in chest trauma. there is still a lack of data to really understand the effects of these techniques on the injured lung after trauma. therefore, the investigators want to do a niv or hfo session and directly assess the effects on participants' lungs by doing a ct at the end of the session. this is a procedure carried out within five days of the initial trauma and consists of either a 10-minute session of non-invasive ventilation or a 10-minute session of high-flow oxygen therapy, depending on which arm the participant is allocated to. two chest cts will be performed: the first as part of usual care before the non-invasive ventilation session or high flow oxygen therapy session, and the second immediately after the 10-minute session. the investigator's objective is to demonstrate an improvement in lung recruitment with niv or hfo using ct imaging.


Eligibility criteria:
inclusion criteria: * age \> 18 years old * chest trauma \< 5 days * at least 3 ribs fracture on initial ct-scan * need of oxygen moderated to maintain monitoring oxygen saturation sp02 \> 92% or partial pressure of arterial oxygen pa02/ fraction of inspired oxygen fio2 \> 200 * intensive care unit admission * need a chest ct control during the five first days after the trauma exclusion criteria: * patient intubated or with respiratory failure : measured or estimated pa02/fio2 \ 35/min, abundant tracheal secretions, significant increase in work of accessory respiratory muscles on inspiration, signs of respiratory exhaustion on arterial blood gas with the potential of hydrogen ph \ 50 mmhg, severe hypoxemia with pao2/fio2 ratio \< 100 or desaturation \< 88% for more than 5 minutes) * inability to maintain 10 seconds of apnoea required for scan acquisition * patient treated with ventilatory support by niv or hfo in the 12 hours prior the investigation * uncontrolled circulatory failure with need for introduction of noradrenaline \> 0,15 ug/kg/min * uncontrolled neurological failure with glasgow coma scale (cgs \< 15 * unstable facial trauma or with pneumocephalus or basilar skull trauma * large, undrained pneumothorax with lateral separation at the level of the hilum \> 2 cm and extensive throughout the axillary line * patients with identified cognitive impairment * persons deprived of liberty, persons under protective measures * persons not affiliated to a social security insurance * current pregnancy or breastfeeding * refusal to participate in the study
mesenchymal stem cells in the treatment of relapsed/refractory severe acquired aplastic anemia

Conditions: Aplastic Anemia

Summary: mesenchymal stem cells have been tested in many autoimmune disorders with encouraging results and may be an alternative to the treatment of immune-mediated severe acquired aplastic anemia.

acquired aplastic anemia is a bone marrow failure syndrome characterized by and empty bone marrow and low blood counts. most of the cases are immune-mediated. allogeneic bone marrow transplant is the preferable treatment modality for patients younger than 40 years with a matched sibling donor. patients not eligible for transplant are treated with intensive immunosuppressive therapy often based on anti-thymocyte globulin and cyclosporine. however, up to one third of patients treated with immunosuppression are refractory and one third of those who response eventually relapse. refractory and relapsed cases may be the result of insufficient immunosuppression and these cases may benefit from additional immunosuppression. mesenchymal stem cells infusion may be a potential treatment option, considering its properties to modulate the immune system. refractory or relapsed patients with aplastic anemia will be treated with conventional immunosuppressive regimen (anti-thymocyte globulin plus cyclosporine) combined with intravenous infusion of allogeneic unrelated bone marrow mesenchymal stem cells.

Eligibility criteria:
inclusion criteria: * diagnosis of acquired aplastic anemia * relapse/refractory to at least 1 immunosuppressive first line treatment * not eligible to allogeneic bone marrow transplantation exclusion criteria: * previous or current malignancy * active or latent infectious disease * positive serologic tests for hiv, hcv, hbv, htlv-1 and 2, syphilis or chagas disease * previous drug reaction for antithymocyte globulin, cyclosporin or corticosteroids * severe organic impairment (renal, hepatic, cardiac, pulmonary) * uncontrolled hypertension or diabetes * pregnancy * previous history of allergic reaction to penicillin or streptomycin * severe psychiatric disorder

Keywords: aplastic anemia mesenchymal stem cells
allogeneic mesenchymal stromal cells for angiogenesis and neovascularization in no-option ischemic limbs

Conditions: Peripheral Arterial Disease; Cardiovascular Diseases; Vascular Diseases

Summary: the primary objective of this trial is to investigate whether intramuscular administration of allogeneic mesenchymal stromal cells (msc) is safe and potentially effective, assessed as a composite outcome of mortality, limb status, clinical status (rutherford classification) and pain score (visual analogue scale), in patients with no-option severe limb ischemia (sli). the investigators will conduct a double-blind, placebo-controlled randomized clinical trial to investigate the effect of allogeneic bone marrow(bm)-derived msc in patients with sli, who are not eligible for conventional surgical or endovascular therapies. the investigators intend to include 60 patients, who will be randomized to undergo 30 intramuscular injections with either bm-msc (30 injection sites with 5\*10\^6 mscs each) or placebo in the lower leg of the ischemic extremity. primary outcome i.e. therapy success, a composite outcome considering mortality, limb status, clinical status (rutherford classification) and changes in pain score, will be assessed at six months.


Eligibility criteria:
inclusion criteria: * age \> 18 years * severe peripheral artery disease (pad; fontaine class iii and / or iv): * fontaine iii (rutherford 4): persistent, recurring rest pain requiring analgesia * fontaine iv (rutherford 5): non-healing ulcers present for \> 4 weeks without evidence of improvement in response to conventional therapies * ankle brachial index \< 0.6 or unreliable (non-compressible or not in proportion to the fontaine classification) * not eligible for surgical or endovascular revascularization * written informed consent. exclusion criteria: * history of neoplasm or malignancy in the past 10 years * serious known concomitant disease with life expectancy of less than one year * rutherford 6 in which amputation on the short term (within 1-2 weeks) is inevitable * pregnancy or unwillingness to use adequate contraception during study * uncontrolled acute or chronic infection with systemic symptoms * follow-up impossible.

Keywords: critical limb ischemia (cli) severe limb ischemia (sli) peripheral artery disease (pad) peripheral artery occlusive disease (paod) cardiovascular disease mesenchymal stromal cell (msc) mesenchymal stem cell (msc)
hkt-500 in adult patients with shoulder pain

Conditions: Pain

Summary: the objective of this study is to determine the efficacy of hkt-500 in subjects with acute shoulder pain

randomized, double-blind, placebo-controlled, multicenter study in men and women 18 years of age or greater who have acute shoulder pain requiring analgesic treatment daily for at least 2 weeks.

Eligibility criteria:
inclusion criteria: * the subject has unilateral acute shoulder pain. exclusion criteria: * the subject is a women of childbearing potential who has a positive urine pregnancy test, or who is lactating, or who is not surgically sterile (by tubal ligation or hysterectomy), or at least 2 years postmenopausal, and has not practiced an acceptable form of birth control (defined as the use of an intrauterine device with spermicide, a barrier method with spermicide, condoms with spermicide, subdermal implant, oral contraceptives, or abstinence) for at least 2 months prior to visit 1.

Keywords: shoulder pain pain ketoprofen topical patch
digital air leak monitoring for patients undergoing lung resection

Conditions: Pneumothorax; Atelectasis

Summary: often the decision for chest tube removal or trial of chest tube clamping is based on subjective assessment. this can lead to delay in chest tube removal. recently, monitoring and recording of air leaks has been done using digital pleural drainage devices. this provides us with objective and continuous recording of air leaks as well as changes in pleural pressure. our hypothesis is that the use of the atmos digital pleural drainage system will result in shorter hospital stay in comparison to traditional pleural drainage systems.

technology has become a driving force in surgery. from robotics to digital monitoring of oxygen saturation, it has revolutionized the way we care for patients. however, new technology comes at a cost to our healthcare system. it is therefore important to ensure that new devices actually improve outcomes. one example of this is minimally invasive surgery, which decreases morbidity to patients and reduces length of hospital stay. unfortunately, despite this advance in lung surgery, delays in discharge from hospital are still prevalent due to prolonged air leaks. many intra-operative methods have been explored in order to limit this issue with underwhelming success. this is why we are proposing a randomized controlled trial comparing a digital pleural collection system by atmos to traditional pleural collection devices by atrium. our research question is: can the use of a digital air leak monitoring system decrease hospital stay in patients undergoing anatomical lung resection when compared to traditional pleural drainage systems?

Eligibility criteria:
inclusion criteria: * patients 18 or older * patients undergoing a lobectomy or segmentectomy exclusion criteria: * patients under the age of 18 * patients undergoing pneumonectomy, wedge resection or bullectomy * patients who require additional procedures to control intraoperative air leak * patients who require mechanical ventilation post-operatively

Keywords: lobectomy segmentectomy pneumothorax pleural digital air leak
effect of direct-acting antiviral drugs on erectile function

Conditions: Hepatitis C

Summary: effect of direct-acting antiviral drugs on erectile function

effect of direct-acting antiviral drugs on erectile function in hcv patients

Eligibility criteria:
inclusion criteria: * hcv infected patients * male exclusion criteria: * hcc * age below 18 years
impact of postoperative transitional pain on recovery after thoracic surgery

Conditions: Postoperative Recovery

Summary: postoperative transitional pain corresponds to the pain occuring between acute postoperative pain and chronic postsurgical pain (defined as pain persisting for at least 3 months after surgery). we hypothesized that both trajectory and neuropathic component of transitional pain may influence the quality of recovery after thoracic surgery. to test this, we designed an observational study to identify risk factors for incomplete recovery assessed through the qor-15 questionnaire.


Eligibility criteria:
inclusion criteria: * adult patients * patients scheduled for thoracic surgery (thoracotomy or video-assisted thoracic surgery or surgery for thoracic outlet syndrome) * patients who do not object to the study exclusion criteria: * patients non francophone * emergency surgery or revision surgery * patients already included in the study during the previous 6 months

Keywords: postoperative transitional pain postoperative pain trajectory postoperative neuropathic pain thoracic surgery
study to evaluate the safety and efficacy of the renal assist device in patients with acute renal failure

Conditions: Kidney Failure, Acute

Summary: * the purpose of this study is to evaluate the safety and efficacy of the rad to determine whether the rad is effective in reducing mortality in patients with acute renal failure due to acute tubule necrosis and to evaluate the safety of the rad * if the rad works normally when used for as long as 72 hours * if the rad will provide added benefits to normal cvvh therapy for patients with acute renal failure

acute renal failure (arf)is a severe inflammatory disease state often accompanied by multi-organ failure (mof) and systemic inflammatory response syndrome (sirs). arf is precipitated by many factors and is most often linked to the loss of kidney tubule cell function. patients with arf are treated in the intensive care units of hospitals and recovery of renal function is vitally important to their survival. current therapy for arf involves conventional kidney support with continuous renal replacement therapies (crrt). despite advances in treating patients with crrt, arf has an extremely high mortality rate (55-70%) and requires extensive hospital stays, predominantly in the icu. the rad is designed to both treat arf with mof and/or sirs and facilitate the natural recovery of a patient's own kidney function. the rad is intended for use for short periods of time in conventional extracorporeal therapeutic systems that are already available in the hospital. the rad therapy operates outside the body, and is designed to mimic the structure and function of the natural kidney. in this manner it is intended to replace the missing metabolic, endocrine, and immunologic functions of the kidney and allow time for the patient's own kidneys to resume normal functions.

Eligibility criteria:
inclusion criteria: * a clinical diagnosis of acute tubular necrosis (atn) * at least one non-renal organ failure exclusion criteria: * a renal transplant at any time * chronic renal failure occurring due to reasons other than acute tubular necrosis (atn) * chronic * chronic immunosuppressive therapy

Keywords: renal failure, acute acute kidney failure acute renal failure acute tubular necrosis anuria renal dialysis acute kidney injury
treatment with hokt3gamma1(ala-ala) in t1dm

Conditions: Diabetes Mellitus, Type 1

Summary: this is a phase ii study to examine the clinical and immunological effects of humanized fcr non-binding anti-cd3 mab in participants with type 1 diabetes mellitus (t1dm), and to develop this therapy to prevent the immune destruction leading to β cell loss.

this is a 2-arm, open-label phase ii trial involving 0 or 3 cycles of treatment 6 months apart with hokt3γ1 (ala-ala), over the first year of disease in participants with new onset t1dm. each cycle consists of 12 daily doses of hokt3γ1 (ala-ala). participants will be randomized in a ratio of 2:1 to either the experimental arm or the control arm and will be stratified by study site. to be eligible, participants must be: male or female between 7-30 years of age, diagnosed with t1dm within the past 6 weeks, have a body weight ≥26 kg at the time of enrollment and have detectable anti-gad, anti-ica512/ia-2, or insulin autoantibodies (if the participant has been on insulin ≤10 days). participants randomized to the experimental group will start the first cycle of hokt3γ1 (ala-ala) within 4-8 weeks of t1dm diagnosis. each participant randomized to the experimental group will receive 3 cycles of drug treatment, separated by 6 months each. each cycle consists of 12 days of drug treatment. both groups will undergo the mixed meal stimulated c-peptide test and receive blood draws for mechanistic studies on the same schedule.

Eligibility criteria:
inclusion criteria: * diagnosed with t1dm within the past 6 weeks * have a body weight ≥26 kg at the time of enrollment * have detectable anti-gad, anti-ica512/ia-2, or insulin autoantibodies (if the participant has been on insulin ≤10 days). exclusion criteria: * pregnant or lactating females; * prior okt3 treatment; * known hypersensitivity to murine products; * uncompensated heart failure or fluid overload, recent myocardial infarction; * history of epilepsy, cancer, active infection, atopic disease, active grave's disease, cystic fibrosis, sickle cell anemia, neuropathy, peripheral vascular disease, cerebrovascular disease, any concurrent autoimmune diseases, asthma; * any medical condition that in the opinion of the investigator will interfere with safe completion of the trial; * inability to give informed consent; * prior participation in a clinical trial that could potentially affect diabetes or immunologic status; * participation in a clinical trial within the last 6 weeks; * hiv positive; * positive for hepatitis b surface antigen or anti-hepatitis c antibody; * seropositivity for toxoplasmosis (igg); * lymphopenia (\<1000 lymphocytes/microliter); * thrombocytopenia (\<150,000/mm3 platelets); * anemia (hgb \< 10g/dl); * vaccination with a live virus within the past 6 weeks; * positive ppd skin test; * any infectious mononucleosis-like illness within the 3 months prior to enrollment; * serologic evidence of acute infection with ebv or cmv based on tests listed and as defined by the protocol.

Keywords: diabetes, juvenile diabetes, teplizumab