Kornimate/medical-research-clean huggingface dataset:
acceptance of uterus transplantation

Conditions: Resolve Infertility

Summary: transplantation of an uterus

uterus transplantation will be performed from live donors to patients with absolute uterine factor infertility. organ procurement from the donor will be performed by laparotomy. transplantation will also be performed by laparotomy. embryo transfer will be done 10-12 months after transplantation. after birth of 1-3 children the uterus will be removed by hysterectomy.

Eligibility criteria:
inclusion criteria: * age below 40 years * absolute uterine factor infertility * bmi \< 30 exclusion criteria: * systemic disease * psychiatric disease
evaluation of efficacy and safety of vx-548 for painful lumbosacral radiculopathy (plsr)

Conditions: Painful Lumbosacral Radiculopathy

Summary: the purpose of the study is to evaluate the efficacy and safety of vx-548 in treating participants with plsr.


Eligibility criteria:
key inclusion criteria: * body weight greater than or equal to (\>=)45 kilogram (kg) * body mass index (bmi) less than or equal to (\<=) 40 kg/ meter square (m\^2) * diagnosis of plsr for greater than (\>)3 months as per criteria pre-specified in the protocol * weekly average of daily nprs score \>=4 and \<10 with limited variation in the 7-day run-in period key exclusion criteria: * more than 3 missing daily nprs scores during the 7-day run-in period * moderate or severe painful neuropathy other than plsr as pre-specified in the protocol * history of prior lumbar spine surgery (e.g., discectomies, laminectomies, foraminotomies, or fusion) other protocol defined inclusion/exclusion criteria may apply.
predictive factors of systolic dysfunction in non-complicated hypertensive patients

Conditions: Hypertension

Summary: hypertension is a major cardiovascular risk factor. heart failure is one of its main complications but the factors that influence its development are still insufficiently known. the primary objective is to determine associated factors to the occurrence of left ventricular (lv) systolic dysfunction assessed by an alteration of the global longitudinal strain (gls) after more than the years of hypertension. the secondary objective is to estimate the prevalence of lv systolic dysfunction in a cohort of hypertensive people followed for over 10 years and formulate pathophysiological hypotheses on the development of this heart disease.

some of the hypertensive patients will develop a post hypertensive heart disease. this hypertrophic cardiomyopathy is now essentially defined by the association of lv hypertrophy and diastolic dysfunction. investigators believe this hypertrophic cardiomyopathy is also characterized by early impairment of systolic function but mainly in its longitudinal component (assessed by measuring the gls) and therefore exposed to cardiovascular events. the work is based on an existing cohort of hypertensive patients included more than 10 years ago before any initiation of antihypertensive therapy in the hypertension unit of the bordeaux university hospital, france. patients will be contacted for further consultation with a cardiologist to identify patients with a lv systolic dysfunction. the primary end-point is a decrease of the longitudinal systolic function with a gls\<-17% for men and \<-19% for women. a sufficient number of patients will be contacted in order to collect data of at least 400 patients after more than 10-year of follow-up.

Eligibility criteria:
inclusion criteria: * patient who was diagnosed as hypertensive more than 10 years ago and who underwent cardiac-echography, ecg, a biological blood test and an ambulatory blood pressure measurement before the introduction of antihypertensive treatment. exclusion criteria: * oral refusal of patient participation or its legal representatives, reading the specific information note for the study.

Keywords: heart failure systolic dysfunction gls arterial stiffness left ventricular hypertrophy
the effects of bromelain supplement in patients with ulcerative colitis

Conditions: Ulcerative Colitis; Primary Sclerosing Cholangitis

Summary: in this study, patients with active mild to moderate uc with or without psc will be randomized to receive either bromlein or placebo along with low fodmap diet for 8 weeks. ibdq, sccaiq, crp, tac, tnf-a will be measured before and after the intervention.


Eligibility criteria:
inclusion criteria: * active mild to moderate uc * no other chronic disorders exclusion criteria: * changed the type and dosage of their medication in the last month * those who have relapses that required hospitalization and change the type and dosage of medications during the intervention * patients who do not want to continue the study protocol
effect of core stability training on segmental trunk control and quality of life in children with cerebral palsy

Conditions: Spastic Diplegia; Cerebral Palsy

Summary: spastic diplegia is a common shape of cerebral palsy that significantly affects trunk control and quality of life in children. core stability training (cst) has been utilized as a potential intervention to improve the trunk function. this study investigated the effects of cst on segmental trunk control and quality of life in children with spastic diplegia. forty children with spastic diplegia (age: 3 - 6 years) were randomly assigned to either a control group (n=20) receiving a selected physical therapy program or an experimental group (n=20) receiving the same program plus a 30-minute cst program three times weekly for 12 weeks. segmental trunk control was assessed using the segmental assessment of trunk control (satco) scale, and quality of life was measured using the pediatric quality of life inventory (pedsql). both outcome measures were evaluated pre- and post-intervention.


Eligibility criteria:
inclusion criteria: * 3-6 years * 1 to 1+ spasticity according to modified ashworth scale * level ii and iii according to gmfcs * able to follow instructions and understand commands exclusion criteria: * significant visual or auditory problems * fixed deformities * botox injection * orthopedic surgery
efficacy and safety study of qlg1080 in patients with hormone-sensitive advanced prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study was to evaluate the efficacy and safety of qlg1080 in patients with hormone-sensitive advanced prostate cancer.


Eligibility criteria:
inclusion criteria: * 1. histological or cytological diagnosis of prostate cancer;； * advanced prostate cancer patients eligible for endocrine therapy, able to receive continuous androgen deprivation therapy for at least 6 months. * serum testosterone ≥150 ng/dl (5.2nmol/l) at screening visit; * the eastern cooperative oncology group (ecog) score is 0 to 1. exclusion criteria: * diagnosed or suspected of hormone-resistant prostate cancer; * for prostate cancer patients who have had or are undergoing endocrine therapy * patients who have previously undergone pituitectomy or adrenalectomy or have pituitary disease or adrenal dysfunction; * those who have had any prostate surgery within 4 weeks prior to initial dosing or prostate surgery or other major surgical treatment during the planned trial period (except urinary tract obstruction relief); * the imaging results of screening visits clearly showed the presence of brain metastases;
screening for sleep apnea in patients undergoing atrial fibrillation ablation

Conditions: Atrial Fibrillation; Obstructive Sleep Apnea; Cardiac Arrhythmias

Summary: diagnosis and treatment of sleep apnea with continuous positive airway pressure (cpap) therapy has been shown to decrease arrhythmia recurrence in patients with af following ablation. however, patients with af undergoing ablation are not routinely screened for sleep apnea, despite an estimated sleep apnea prevalence of 25% in the general population, and perhaps higher among patients with af. home sleep testing is frequently used for evaluation of sleep apnea.

the american academy of sleep medicine considers atrial fibrillation (af) to be high risk for sleep disordered breathing, and recommends that those with af be evaluated for sleep apnea in its clinical guidelines. however, this has not yet become standard practice. the primary reasons for this are that sleep apnea remains under-suspected and under-diagnosed by electrophysiology physicians treating patients with af, overnight sleep studies are cumbersome and are frequently associated with patient discomfort and high cost, and a mechanism for coordinating sleep apnea screening and treatment referral has not been established in electrophysiology clinics. the gold standard for the diagnosis of sleep apnea is overnight polysomnography, typically conducted in a sleep laboratory, which can be costly and cumbersome for patients. home sleep studies are fda-approved for the diagnosis of sleep apnea and offer patients the opportunity to be assessed in a more natural sleep environment, and often in a more timely manner. it has been demonstrated that diagnosis and treatment of sleep apnea reduces the risk of arrhythmia recurrence following af ablation to a level comparable to those without sleep apnea. the goal of this study is to examine the feasibility of screening all patients undergoing af ablation for sleep apnea, and to refer those patients with sleep apnea for evaluation and treatment by a sleep specialist.

Eligibility criteria:
inclusion criteria for the study include: 1. patients age 18 years and older. 2. patients with the diagnosis of atrial fibrillation presenting for clinical ablation procedure. exclusion criteria for the study include: 1. patients with an existing diagnosis of sleep apnea. 2. patients who are unable to provide informed consent.
rasagiline for the symptomatic treatment of fatigue in parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of the research study is to determine if rasagiline is an effective treatment for fatigue in patients with parkinson's disease (pd).

despite the fact that fatigue affects 40-50% of all patients with pd and is a leading cause of disability, we currently do not have any effective treatments for this symptom. rasagiline is a well-tolerated and effective treatment for the motor symptoms of pd. rasagiline is a mao-b inhibitor that may decrease the breakdown of dopamine. many patients report an improvement in their energy levels when on this medication. a proven treatment for pd fatigue would significantly improve the quality of life for numerous patients and their caregivers.

Eligibility criteria:
inclusion criteria: 1. a clinical diagnosis of idiopathic pd by a movement disorders specialist. all subjects will be diagnosed using the uk brain bank criteria (hughes et al., 1992). 2. age between 40-85 years. 3. able to sign and understand informed consent; and cognitively able to carry out the procedures in the study 4. stable on all pd medications for at least 30 days; and psychotropic medications for at least 90 days. 5. treatment naïve subjects who are appropriate candidates to begin mao-inhibitor monotherapy as treatment for their pd may also be included in this study. 6. fatigue severity scale ≥ 36 (krupps et al., 1989) exclusion criteria: 1. clinically significant medical disease that is associated independently with fatigue (e.g. significant cardiac or pulmonary disease, anemia, obstructive sleep apnea, liver or kidney failure). 2. history of neurological illnesses other than pd or a history of a significant head trauma (involving unconsciousness). 3. evidence of secondary or atypical parkinsonism as suggested by the presence of any of the following: 1) history of stroke(s), 2) exposure to toxins or neuroleptics, 3) history of encephalitis, 4) neurological signs of upper motor neuron disease, cerebellar involvement, supranuclear gaze palsy, or significant orthostatic hypotension. 4. mri or ct scan with significant evidence of brain atrophy or other abnormalities (e.g. lacunar infarcts or iron deposits in the putamen. 5. clinical diagnoses of dementia; or an mmse score of \< 25. 6. unstable, newly diagnosed, or newly treated (i.e. less than 3 months) major psychiatric disorder such as depression or anxiety 7. beck's depression inventory score \>14. 8. current or prior placement of deep brain stimulator. 9. currently taking an mao-b inhibitor or medications which are used as fatigue treatments, including amantadine, modafinil, methylphenidate, atomoxetine or other psychostimulants. 10. previously taken an mao-b inhibitor for more than 2 weeks. 11. hypersensitivity to rasagiline or its products 12. on mirtazapine, venlafaxine, regular use of compounds with vasoconstrictors, tramadol, meperidine, propoxyphene, dextromethorphan, st. john's wort, cyclobenzaprine 13. on omeprazole, ciprofloxacin or drugs that are metabolized through cyp1a2

Keywords: parkinson's disease fatigue
a long-term follow-up study in participants who received cs-101

Conditions: Beta-Thalassemia

Summary: this is a study to evaluate the long-term safety and efficacy of cs-101 in participants who received cs-101 in study cs -101-03 (nct06065189)

this is a study to evaluate the long-term safety and efficacy of cs-101 in participants who received cs-101 in study cs -101-03 (nct06065189) . subjects in the cs-101-03 study will be entered into long-term follow-up of this study up to 2 years post-infusion at the completion of the last (6-month) follow-up visit after treatment with cs-101 injection.

Eligibility criteria:
inclusion criteria: * participants (or his or her legally appointed and authorized representative or guardian) must sign and date informed consent form (icf) and, where applicable, an assent form * participants must have received cs-101 infusion in last iit study exclusion criteria: * there are no exclusion criteria
anti-inflammatory cells in peritoneal cavity

Conditions: Ovarian Cysts; Chronic Renal Insufficiency

Summary: some subsets of lymphocytes are able to inhibit immune response and thus, could be used to control auto-immune diseases and transplant reject. in mice, the main source of those anti-inflammatory lymphocytes is the peritoneal cavity. no data are available in human. this study aims at exploring the presence of those anti-inflammatory lymphocytes in human peritoneal cavity and at determine how to expand those cells.

b cells will be collected during procedures planned for patients' standard care. peritoneal fluid and peripheral blood of patients will be collected during coelioscopy for exploration of ovarian cysts or dialysis for treatment of chronic renal insufficiency. regulatory b cells (breg cells) will be measured in peritoneal fluid and in peripheral blood after in vitro stimulation and assessment of intracellular interleukin-10 by flow cytometry. proportion of breg cells among b cells will be compared between peritoneal fluid and peripheral blood in both groups. different protocols to induce differentiation of b cells into breg cells will be tested and compared.

Eligibility criteria:
inclusion criteria: * woman over 18 year old undergoing exploration of ovarian cysts by coelioscopy * patient with chronic renal insufficiency undergoing peritoneal dialysis * informed consent obtained exclusion criteria: * pregnancy or breast-feeding * non affiliation to health care insurance * treatment with corticosteroids over 15 mg/day * treatment with rituximab

Keywords: peritoneal fluid b cells regulatory b cells human
efficacy of subfascial approach in thyroidectomy to quality of life in thyroid disease patients

Conditions: Thyroid Cancer

Summary: subfascial approach method in thyroidectomy maybe result in better quality of life than conventional approach method in thyroid disease patients


Eligibility criteria:
inclusion criteria: * micropapillary thyroid cancer exclusion criteria: * lateral neck lymph node metastasis * severe thyroiditis * goiter * reoperation * extrathyroidal extension
study of the efficacy and safety of amag-423 (digoxin immune fab) in antepartum subjects with severe preeclampsia

Conditions: Severe Preeclampsia

Summary: this study evaluates the use of amag-423 (digoxin immune fab) in addition to expectant management in the treatment of severe preeclampsia as compared to placebo.


Eligibility criteria:
inclusion criteria: * fetal gestational age 23 0/7 to 31 6/7 weeks * treated with expectant management * meets modified acog criteria for severe preeclampsia * willing and able to provide written, informed consent exclusion criteria: * decision to deliver within 24 hours has been made * weight \> 150 kg * eclampsia * significant antecedent obstetrical problems * clinically significant fetal anomaly or chromosomal abnormalities * chronic renal disease * active hepatic disease, antiphospholipid antibody syndrome, or lupus * unstable medical or psychiatric disorder * need for use of digitalis like products * history of anaphylactic allergic reactions * prior use of antibodies/fab fragments from sheep * serum creatinine ≥ 2.0 mg/dl * platelet count \< 50,000 * pulmonary edema * estimated fetal weight \< 5th percentile
evaluation of reliability and validity of a smart-phone postural control assessment application

Conditions: Other Instability, Ankle and Foot

Summary: the purpose of this study is to evaluate the reliability and validity of smart-phone based system in postural control ability assessment on subjects with chronic ankle instability.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of ankle functional instability exclusion criteria: * any other condition would affect postural control performance

Keywords: smart-phone assessment chronic ankle instability
hypertonic saline-hetastarch in cardiac surgery

Conditions: Postoperative Cardiorespiratory Failure

Summary: cardiopulmonary bypass(cpb) is associated with increased fluid extravasation and edema formation. a continuous infusion of a mixture of hypertonic saline/hydroxyethyl starch (hsh)during cpb reduced fluid extravasation and total fluid gain during bypass in an animal model. we hypothesize that a continuous infusion of hsh will reduce fluid load and increase hemodynamic and respiratory functions in patients undergoing coronary artery bypass with cpb.

cardiopulmonary bypass (cpb) is associated with fluid overload and edema formation occasionally resulting in vital organ dysfunction affecting heart, respiratory system , gastrointestinal tract and brain. hyperosmolar/hyperoncotic preparations (hsh/hsd) have been used in cardiac surgery essentially with the aim to mobilize fluid excess and improve postoperative cardiorespiratory function.most studies dealing with the administration of hsd or hsh during and after cpb, have used protocols recommended for treatment of severe hypovolemia and shock, that is 4 ml/kg as a bolus, given within minutes.in animal experiments we have used hsd or hsh, 1 ml/kg/h to a total dose of 4 ml/kg during cpb. the use of hsh/hsd reduced the total fluid gain about 50 % and resulted in significantly lower content of tissue water in vital organs as heart and lungs. in the actual clinical trial we hypothesize that a continuous infusion of hsh will reduce fluid load and increase hemodynamic and respiratory functions monitored with the picco system in patients undergoing coronary artery bypass with cpb.

Eligibility criteria:
inclusion criteria: * patients scheduled for elective coronary artery bypass graft surgery exclusion criteria: * age \ 75 years * bmi\ 30 * left ventricular ejection fraction \< 40% * emergency operations * additional valvular diseases * impaired renal function * serum sodium\> 145 mmol/l * hematocrit\< 30% * use of clopidogrel the last 5 days

Keywords: fluid balance respiratory function cardiac function inflammation cardiopulmonary bypass
safety and efficacy of romidepsin and the therapeutic vaccine vacc-4x for reduction of the latent hiv-1 reservoir

Conditions: HIV I Infection

Summary: the reduc trial's objective is to address one of the core issues with the treatment of hiv, which is that some hiv infected cells hide in so-called latent reservoirs. the reservoirs are unaffected by conventional hiv medication and invisible to the immune system. hdaci have the potential to activate these latently infected cells. this will make the hiv infected cells visible to the immune system; the immune response generate by vacc-4x will be able to attack and eliminate the infected cells.

the study is divide into two parts. in part a the safety and tolerability of romidepsin will be evaluated and the effect of romidepsin treatment on hiv-1 transcription in hiv-infected patients virologically suppressed on cart will be determined. in part b the effect of treatment with vacc-4x + rhugm-csf and romidepsin treatment on the hiv-1 latent reservoir in hiv-infected patients virologically suppressed on cart will be measured. six patients will be enrolled for part a and the safety and tolerability profile evaluated before enrolling 20 patients in b.

Eligibility criteria:
inclusion criteria: 1. age \>18 years 2. currently receiving cart and having received cart for a minimum of 1 year 3. hiv-1 plasma rna \<50 copies/ml for at least 1 year (excluding viral load blips) 4. cd4 t cell count ≥500 cells/mm3 exclusion criteria: 1. cd4 t cell count nadir \<200 cells/mm3 2. previous treatment with an hdaci (histone deacetylase inhibitor) within the previous 6 months 3. any evidence of an active aids-defining opportunistic infection, active hbv or hcv co-infection, significant cardiac disease, malignancy, transplantation, insulin dependent diabetes mellitus or other protocol defined excluded medical condition 4. use of any protocol defined contraindicated medication or vaccination 5. unacceptable values of the hematologic and clinical chemistry parameters as defined in the protocol. 6. males or females who are unwilling or unable to use protocol defined methods of contraception
prevalence of mafld among nurses and the role of intermittent fasting

Conditions: Fatty Liver Disease

Summary: this study consists of 2 parts: part 1: a cross-sectional study, looking at the prevalence of metabolic dysfunction-associated fatty liver disease (mafld) among nurses in hospital canselor tuanku muhriz (hctm). part 2: a randomized controlled trial of intermittent fasting with mafld subjects.

the investigators aim to screen at least 350 participants for fibroscan-detected fatty liver. baseline anthropometric data will be taken. questionnaires on dietary habits - foof frequency questionnaire (ffq) and exercise habits - international physical activity questionnaire (ipaq) will be done. approximately 100 participants who have fatty liver from part 1 study, will be enrolled and randomized into part 2. the intervention group will undergo intermittent fasting (3 fasting day:4 non-fasting days) while the control group will continue the usual standard care, for 8 weeks. measurements pre- and post-intervention include fibroscan measurement, blood liverfast, anthropometric data, and exercise habit (ipaq).

Eligibility criteria:
inclusion criteria: * nurses at hctm, 18 years and above exclusion criteria: * pregnancy * previous bariatric surgery * liver cirrhosis * liver cancer * steatogenic drugs

Keywords: fatty liver mafld intermittent fasting transient elastography fibroscan