Kornimate/medical-research-clean huggingface dataset:
dose escalation study of ucart19 in adult patients with relapsed / refractory b-cell acute lymphoblastic leukaemia

Conditions: B-cell Acute Lymphoblastic Leukemia

Summary: the study is in two parts: a dose escalation then a safety dose expansion. the purpose of the dose escalation part is to evaluate the safety and tolerability of ascending doses of ucart19 (dose-escalation part) given as a single infusion in patients with relapsed / refractory (r/r) b-cell acute lymphoblastic leukaemia (b-all), to determine the maximum tolerated dose (mtd), the recommended dose and the lymphodepletion regimen. the purpose of the safety dose expansion is to assess the safety and tolerability of the rd for ucart19.


Eligibility criteria:
inclusion criteria: * male or female participant * age ≥ 16 years * patient with relapsed or refractory cd19 positive b-acute lymphoblastic leukaemia (b-all) who have exhausted alternative treatment options * estimated life expectancy ≥ 12 weeks (according to investigator's judgement) * eastern cooperative oncology group (ecog) performance status \< 2 exclusion criteria: * previous treatment with gene or gene-modified cell therapy medicine products or adoptive t cell therapy * use of previous anti-leukemic therapy (including approved therapies and other investigational products) within 5 half-lives prior to ucart19 administration * cd19 negative b-cell leukaemia * burkitt cell or mixed lineage acute leukaemia
antibiotic prophylaxis in clean surgery. impact on surgical site infection

Conditions: Surgical Site Infection

Summary: this is a randomized control study of antibiotic uses in clean non prosthetic surgeries. one group will be given antibiotic prophylaxis, other will receive a placebo. the primary outcome will be the rate of surgical site infection in 2 groups.

i will conduct a randomized controlled trial (rct) of antibiotic prophylaxis versus placebo in clean, non-prosthetic, elective procedures. the intervention will be a single dose of prophylactic antibiotic (cefazolin): 2 gr in adults or 3 gr for patients weighing \>120kg and 30mg/kg in children) within 30-60 minutes prior to skin incision. the control group will receive a similarly prepared placebo injection (water for injection) 30-60 minutes prior to incision. i will randomize patients in a 1:1 allocation ratio using a simple randomization. patients will randomly pick an envelope with a number allocating to antibiotic prophylaxis or placebo. patients and caretakers will be blinded to the intervention. the surgeon will also be blinded to the intervention. the antibiotic (or placebo) will be pre-mixed by the study investigator and administered by the anesthetist. other preventive measures for surgical site infection (ssis) such as effective surgical hand scrub, proper skin preparation with povidone and sterility of materials and instrument will be applied systematically in all groups. dressing of the wound will be removed 48 hours after operation and no further dressing will be required. patients will be followed for development of ssi documented by surgeon at discharge and will be called after 30 days of surgery to address any sign of ssi.

Eligibility criteria:
inclusion criteria: * - all elective non-prosthetic surgical procedures such as hernia, thyroid, hydrocele, undescended testes surgery, removal of orthopedic implants, low risk breast surgical procedures and other all procedures deemed to be clean. exclusion criteria: * - emergency cases * any patient with american society of anesthesiologists score (asa)\>2 * procedures lasting more than 2 hours * patients who were taking antibiotics 2 days prior to operation
gradual withdrawal of low-dose glucocorticoid in clinically quiescent systemic lupus erythematosus.

Conditions: Systemic Lupus Erythematosus, SLE

Summary: this study aims compare the flare rate of maintenance versus gradual withdrawal of 5 mg/day prednisone in systemic lupus erythematosus (sle) patients with clinically quiescent disease.

glucocorticoids (gcs) remains the mainstay of treatment in sle. prolong used of glucocorticoid can be leading to various organ damage, even in low dose (\< 7.5 mg/day). the rational of tapering gcs in sle who achieve remission or low disease activity is still debated. recent trial showed the abrupt discontinuation of gcs in sustained clinical remission of sle increased rate of flare. this study aims compare the flare rate of maintenance versus gradual withdrawal of 5 mg/day prednisone over 24 weeks in systemic lupus erythematosus (sle) patients with clinically quiescent disease.

Eligibility criteria:
inclusion criteria: * aged; 20 years * diagnosis of sle according to systemic lupus international collaborating clinic (slicc) classification sle criteria, 2012. * achieved clinically quiescent sle defined as csledai-2k = 0 for at least 6 months. * current treatment regimen including prednisolone 5mg/day. prednisolone, antimalarials and/or immunosuppressive therapy had to be stable for at least 4 weeks before randomization. exclusion criteria: * pregnant or pregnancy planning * unable to follow the schedules * overlap with other autoimmune disease, except secondary sjs and aps * co-morbid with any other condition which required prednisolone treatment * documented adrenal insufficiency

Keywords: systemic lupus erythematosus glucocorticosteroid flare
effects of neuromuscular electrical stimulation on exercise capacity in respiratory critically ill patients

Conditions: Critical Illness Myopathy

Summary: neuromuscular electrical stimulation (nmes) implemented during the intensive care unit(icu) stay may improve exercise capacity and prevent muscular weakness in critically ill patients with respiratory disease. main objective: to evaluate, in respiratory critically ill patients, the effects of a conventional physiotherapy program with or without additional nmes applied only during the icu stay on exercise capacity. design: randomized, controlled, double-blind clinical trial on patients (\>18yo) with diagnosis on admission of acute or acute on chronic respiratory disease, on mechanical ventilation (mv) \> 72h and expected mv \> 24h. intervention: conventional physiotherapy with or without 30-minutes (5days/week) on quadriceps femoris and gluteus maximus. patients in the control group will follow the same protocol but the device will not be activated. measures: demographic data, body composition through bioelectrical impedance analysis (bia), and functional capacity before admission through barthel scale will be registered upon inclusion. exercise capacity through test sit-to stand, muscular strength through medical research council (mrc) score and dynamometry, body composition through bia, and functional capacity through barthel scale will be obtained at icu and hospital discharge.


Eligibility criteria:
inclusion criteria: * diagnosis at admission: acute or acute on chronic respiratory disease * mechanical ventilation \> 72h at inclusion * expected mechanical ventilation \> 24h * informed consent exclusion criteria: * patients re-admitted to icu (no hospital discharge) * exitus or transfer to another service/hospital * respiratory instability \[inspired fraction of oxygen (fio2) \>60% or positive end-expiratory pressure (peep) \>10 cmh2o\] and/or hemodynamic instability \[mean arterial pressure ( map)\ 24h. * pregnancy * neuromuscular disease before admission * skin lesions * limitation of therapeutic effort * mental and/or physical limitation to understand/realize tests for evaluation

Keywords: physiotherapy neuromuscular electrical stimulation exercise capacity
safety, pharmacokinetics and efficacy of pp405 in adults with aga

Conditions: Androgenetic Alopecia

Summary: the study is a two part study, designed to validate safety results from the phase 1 pp405-001 trial while also characterizing longer term safety and pk. part 1 of the trial is the randomized controlled portion that will focus on safety and pk following 28 days of blinded treatment administration with either pp405 or vehicle control. part 2 of the trial is an open-label extension that will validate the results of part 1 with 3 months of treatment administration.

safety, pharmacokinetics, and efficacy study of pp405 in subjects with androgenetic alopecia.

Eligibility criteria:
inclusion criteria: 1. male or female subjects aged 18 to 55 years. 2. able and willing to provide written informed consent. 3. males must have an aga modified norwood-hamilton classification score of type iii vertex, type iv or type v. females must have a savin classification score of i-2, i-3 or i-4. 4. agree to comply with protocol procedures exclusion criteria: 1. concomitant diagnosis of non-aga forms of alopecia. 2. use of other hair loss treatments within periods specified in protocol. 3. use of excluded medications as specified in protocol. 4. diagnosis of other medical conditions as specified in protocol. 5. any disease or medical condition that, in the opinion of the investigator, would prevent the subject from participating in the study or might confound study results.
micro-embolic signals detection with transcranial holter in acute ischemic stroke

Conditions: Stroke

Summary: in acute ischemic stroke, the identification of an etiology is of major importance to prevent recurrence by providing the best treatment. because of numerous possible underlying etiologies, the etiological work-up of ischemic stroke includes a wide range of diagnostic tests, which can be invasive, long and expensive. moreover, many patients receive a diagnosis of undetermined stroke even after all available diagnosis tests are done, precluding optimal treatment.

asymptomatic mes detected by transcranial doppler have been reported in patient with ischemic stroke. it has been previously demonstrated that mes predict stroke recurrence and that the frequency of mes depends on stroke etiology. however, the pattern of mes has never been correlated to stroke etiology. transcranial-holter is a novel ambulatory system which allows prolonged recording (up to 4 hours) leading to an increased detection of mes. therefore, transcranial holter with an 4 hour-recording will be performed for consecutive eligible patients hospitalized in our stroke care unit. during the recording, the patient will be able to continue their usual activities (eating, walking, speaking and sleeping). all the included patients will have a classical follow-up at 3, 6 months and 12 months. the neurologist, blinded to the results of transcranial-holter, will have to prescribe and analyze the results of diagnostic tests to identify stroke etiology. stroke etiology will be established according to the ascod classification. questioning and neurological exam (nihss score) will be performed looking for potential recurrent stroke.

Eligibility criteria:
inclusion criteria: * ischemic stroke in the middle cerebral artery territory * acute ischemic stroke within the 7 first days from the onset of the symptoms * patient hospitalized in our stroke care unit * man or woman older than 18 years * patient affiliated to a social security system * free consent, informed writing signed by the participant or the person of confidence and the investigator (no later than the day of inclusion and before any examination required by research) exclusion criteria: * transient ischemic stroke * ischemic stroke in the vertebro-basilar or anterior cerebral artery territory. * proximal middle cerebral artery occlusion leading to the impossibility of recording * patient who could not express his consent * patient under guardianship or judicial protection * pregnant or breastfeeding woman * emergency situation * life expectancy under 6 months exclusion criteria (after inclusion) : * absent of bilateral acoustic window * analyzable recording \<30min

Keywords: stroke etiology recurrence transcranial holter microembolic signals
azelastine allergen chamber - onset of action study

Conditions: Seasonal Allergic Rhinitis

Summary: this study is to assess the onset of action and efficacy of azelastine hydrochloride 0.15% in treating the nasal symptoms of seasonal allergic rhinitis (sar) induced by an allergen challenge in an environmental exposure unit (eeu) followed by a single dose and a 3-day treatment at home.


Eligibility criteria:
main inclusion criteria: * male or female subjects (childbearing and non-childbearing potential, non-childbearing potential defined as females with no menstruation for at least 1 year at screening and documented fsh \> 35 iu/l) aged 18 to 55 years (inclusive) at screening. * history of sar to ragweed pollen for at least the previous 2 ragweed pollen seasons. * positive skin prick test (spt) response to ragweed pollen (allergen induced wheal diameter at least 3 mm larger than the negative control). a test performed at cliantha research in the previous 12 months may be used to qualify the subject. main exclusion criteria: safety concerns: * history of allergic reaction to azelastine hydrochloride, olopatadine hydrochloride, mometasone furoate, or one of the excipients / components of the study treatments * history of anaphylaxis, cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, metabolic, psychiatric, neurological, or other disease at screening that may affect subject safety during the study or evaluation of the study endpoints at the discretion of the investigator and/or designee. * subjects with a current diagnosis of asthma or subjects with measured forced expiratory volume in 1 second (fev1) \<75% of the predicted value using global lung function initiative set from 2012 for references. * pregnant, breast-feeding, or planning a pregnancy during the study and women of childbearing potential not using adequate contraception. lack of suitability for the study: * use of prohibited therapies as specified in the respective table of the protocol. * acute or chronic sinusitis or non-allergic rhinitis, at the discretion of the investigator and/or designee.
vacuum erection device in improving recovery of erectile function in patients with prostate cancer undergoing surgery

Conditions: Male Erectile Disorder; Prostate Cancer; Sexual Dysfunction

Summary: the purpose of this study is to determine which technique in using a vacuum erection device (ved) is best. erectile dysfunction (ed) after robotic prostate cancer surgery is a concern for both the surgeon and the patient. recent studies have shown that beginning to use the vacuum pump on a daily basis starting with in 2-8 weeks may help prevent the start of penile shrinkage. this is a potential issue that can occur because of decreased blood flow after prostate cancer surgery. this study will allow researchers to determine and compare vacuum therapy techniques and erectile function outcomes of patients who have prostate cancer surgery

primary objectives: i. determine sexual function and penile morphometric outcomes for the post-robotic-assisted laparoscopic prostatectomy (ralp) patients undergoing daily vacuum therapy using one of two randomized methods and whether these outcomes differ. secondary objectives: i. compare compliance rates between the two randomized groups using the compliance questionnaire and a diary collected from patients at each follow up visit. ii. compare overall patient satisfaction with the recovery procedure between the two randomized groups utilizing the shim (sexual health inventory for men) questionnaire. outline: patients are randomized to 1 of 2 treatment groups. group a: patients receive vacuum therapy daily over 10 minutes while holding erection for 2 minutes after undergoing ralp. patients complete erection process 5 times. group b: patients receive vacuum therapy daily over 10 minutes while holding erection for 5 minutes after undergoing ralp. patients complete erection process 2 times. after completion of study treatment, patients are followed up at 3, 6, and 12 months.

Eligibility criteria:
inclusion criteria: * sexually active men without the consistent use of erectile aids pre-operatively (i.e. oral pharmacotherapy, intraurethral prostoglandin e1 \[pge1\], intracavernosal injection therapy and penile implants) * undergoing a bilateral nerve sparing robotic prostatectomy * pre-operative baseline shim total score of greater than or equal to 17 * presence of a female sexual partner * dexterity necessary to operate vacuum pump exclusion criteria: * has a history of cardiac failure, angina, or life-threatening arrhythmia within the past 6 months * has taken or has been prescribed nitrate medication in any form in the last 6 months * has a known sensitivity to phosphodiesterase type 5 inhibitors such as sildenafil, tadalafil or vardenafil * men with sickle cell anemia * men with insufficient manual dexterity to operate vacuum device * men with a history of known penile deformity or peyronie's disease * pre or postoperative androgen therapy * pre or postoperative radiation therapy to pelvic area * men actively smoking at time of enrollment, 1 pack per day or more

Keywords: male erectile disorder prostate cancer laparoscopic prostatectomy
improving health outcomes of diabetic veterans: a diabetic self-management program

Conditions: Diabetes

Summary: control of the blood sugar prevents complications and results in extra years of life in patients with diabetes. practice guidelines delineating specific ways physicians manage diabetes have been outlined. missing are guidelines for health care providers to encourage patients to take responsibility for their diabetes. traditional patient education models have been ineffective in managing diabetic persons because they have relied upon information given alone and are disease centered rather than patient centered. this study will explore the role of self-efficacy in helping veterans move toward healthy behaviors.

background: control of the blood sugar prevents complications and results in extra years of life in patients with diabetes. practice guidelines delineating specific ways physicians manage diabetes have been outlined. missing are guidelines for health care providers to encourage patients to take responsibility for their diabetes. traditional patient education models have been ineffective in managing diabetic persons because they have relied upon information given alone and are disease centered rather than patient centered. this study will explore the role of self-efficacy in helping veterans move toward healthy behaviors. objectives: the long-term objectives are to: 1) increase recognition of veteran�s responsibility for health; 2) develop more effective skills in managing chronic conditions; and 3) explore the role of self-efficacy in facilitating improvements in health behaviors and health care utilization. methods: this is a prospective, randomized controlled clinical trial of 2,068 cognitively intact, diabetic veterans. the outcome measures (health behaviors, self-efficacy, health status and health care utilization) will be measured using self-rated scales developed and tested by lorig and colleagues from stanford university. glucose levels and bmi changes will be evaluated using information documented in the medical record. status: enrollment (a total of 326 patients) is closed. all necessary data have been received and are being analyzed.

Eligibility criteria:
inclusion criteria: cognitively intact diabetic veterans. exclusion criteria:
improvement of anorectal function while preserving of inferior mesenteric artery performing left hemicolectomy for diverticulosis

Conditions: Defecatory Disorders After Left Colonic or Rectal Resection

Summary: the aim of the study is to evaluate the anorectal function after hemicolectomy if we preserve or not the inferior mesenteric artery (ima). this study wants to demonstrate that ima preservation could improve patient's quality of life reducing incontinence and/or constipation rate.


Eligibility criteria:
inclusion criteria: * age from 18 to 80 years * bmi\<35 * presence of symptomatic diverticular disease * asa i-iii exclusion criteria: * age \> 80 years * bmi\>35 * asa iv * hinchey iii-iv * past performed procedure that could be modify the nervous pattern (i.e. colorectal surgery, left nephrectomy, hysteroannessectomy)
comparison of microbiome composition and biomarkers in pharmaco resistant and pharmaco-sensitive epilepsy

Conditions: Epilepsy in Children; Pharmaco-Resistant Epilepsy

Summary: the purpose of this study is to determine stool microbiome composition and biomarkers that are differentially abundant and those that are associated with response to treatment (eg, anticonvulsant drugs).

recent research suggests that the intestinal microbiota plays a central role in human health, and may play a role in a variety of central nervous system disorders, including seizure susceptibility. the microbiota has been shown to be associated with changes in factors relevant to neurotransmission, including neurotransmitter signaling, synaptic protein expression, long-term potentiation, and myelination. in addition to the microbiota's potential role in general neurotransmission, research suggests that the gut microbiome may differ between patients with pharmaco resistant and pharmaco-sensitive epilepsies. in support of this idea, ketogenic diet has been used as an alternative treatment for those with pharmaco-resistant epilepsy and there are indications of possible direct interactions of anti-epileptic drugs (aeds) with the intestinal microbiota.

Eligibility criteria:
inclusion criteria: * study participant and/or legal representative is willing and able to give informed consent/assent for participation in the study. * study participant and/or legal representative is willing and able to comply with all study requirements, in the opinion of the investigator. * study participant is between the ages of 12 and 21, inclusive, at the screening visit. * study participant resides at home (alone or with family). * study participant has a confirmed diagnosis of epilepsy (epilepsy groups only; not applicable to sibling controls). * study participant has continued unprovoked seizures despite trials of ≥2 appropriate antiepileptic drugs at therapeutic doses (pharmaco resistant epilepsy group only; not applicable to pharmaco sensitive epilepsy group or sibling controls). exclusion criteria: * study participant has monogenic epilepsy. * study participant has a neurodegenerative disease, mitochondrial disease, metabolic disease, active central nervous system disease, active autoimmune disease, or active inflammatory bowel disease. * study participant is on, or has been on within 30 days prior to the screening visit, a ketogenic diet, low glycemic index diet, or modified atkins diet therapy. * study participant has had surgery within 3 months of the screening visit. * study participant is a resident in a group or hospital setting. * study participant requires the use of a g-tube or formula feeding. * study participant has had antibiotic therapy within 60 days prior to the screening visit. * study participant has participated in the study of an investigational product within 3 months prior to the screening visit (or within 5 half lives of the investigational product, whichever is longer) or is currently participating in a study of an investigational product.

Keywords: epilepsy