Kornimate/medical-research-clean huggingface dataset:
new frontiers on bariatric surgical procedures: classical bypass for type-2 diabetic patients with obesity grade i

Conditions: Diabetes Mellitus, Type 2; Insulin Resistance; Obesity

Summary: bariatric surgery leads to remission of type 2 diabetes in morbid obese patients in 80% (roux-en-y gastric bypass)to 90% (biliopancreatic diversion and duodenal switch) of cases. the current consensus supports bariatric surgical treatment for diabetic patients with bmi as low as 35kg/m2 but it has questioned that lower body mass patients might benefit of the surgery as well. this study is proposed to describe the effects of roux-en-y gastric bypass in mild obese (bmi 30-35) human volunteers on incretins, insulin production and sensitivity and its clinical (diabetic chronic complications) and metabolic impact.

bariatric surgery leads to remission of type 2 diabetes in morbid obese patients in 80% (roux-en-y gastric bypass)to 90% (biliopancreatic diversion and duodenal switch) of cases; most of the remainder achieve better glycemic control, even if they regain weight. the current consensus supports bariatric surgical treatment for diabetic patients with bmi as low as 35kg/m2 but it has questioned that lower body mass patients might benefit of the surgery as well. actually, many clinical researchers worldwide would consider a lower limit bmi of 30kg/m2, i.e., any grade of obesity. this study is proposed to describe the effects of roux-en-y gastric bypass (fobi-capella technique, adapted to create a larger gastric pouch, about 80ml)in mild obese (bmi 30-35) human volunteers on incretins, insulin production and sensitivity and its clinical (diabetic chronic complications) and metabolic impact.

Eligibility criteria:
inclusion criteria: * obesity grade i (bmi 30-34,9) * weight variance less than 5% in the last 3 months. * previous diagnosis of diabetes type 2. * insulin requirement, alone or along with oral agents * capacity to understand the procedures of the study. * to agree voluntarily to participate of the study, signing an informed consent. exclusion criteria: * positive anti-gad antibodies * laboratorial signal of probable failure of insulin production, i. e., seric peptide c lesser than 1 ng/ml. * history of hepatic disease like cirrhosis or chronic active hepatitis. * kidney dysfunction (creatinine \> 1,4 mg/dl in women and \> 1,5 mg/dl in men). * hepatic dysfunction: aspartate aminotransferase or alanine aminotransferase 3x above upper normal limit. * recent history of neoplasia (\< 5 years). * use of oral or injectable corticosteroids for more than consecutive 14 days in the last three months.

Keywords: diabetes mellitus, type 2 insulin resistance intra-abdominal fat omentum duodenal exclusion bariatric surgery glucagon-like peptide 1 gastric inhibitory polypeptide insulin glucagon ghrelin adiponectin cytokines
application of the apsara thermal wand system

Conditions: Tightening of Skin Laxity

Summary: the purpose of this feasibility study is to gain an initial assessment of the acute safety and performance of the apsara thermal wand system in human facial tissue.


Eligibility criteria:
inclusion criteria: * nonsmoker * glogau class 1-3 * previously chosen to undergo facelift exclusion criteria: * pregnant, nursing * implanted electro-mechanical device * allergy to anesthesia or device metals * collagen vascular disease * history of keloid or hypertrophic scar formation * uncontrolled diabetes * long term steroid or other immunologic inhibitor use * previous treatment to target area * does not consent to study * does not consent to photography or histological evaluation

Keywords: skin laxity, wrinkles, rhytids
4-question "racy" delirium screening tool validation study

Conditions: Delirium

Summary: delirium is a serious medical condition associated with increased mortality, longer hospital stay, increased rates of institutionalisation, and declines in post-admission functionality. despite the prognostic utility of diagnosing delirium and its utility as an important indicator of health quality in elderly patients in developed countries, it is not routinely screened for in many busy general medical in-patient settings, especially in developing countries. unpublished data from a recent study of general medical in-patients in groote schuur hospital, cape town, south africa, found that no patients admitted during an 8-week period received any formal cognitive testing or had documentation of the presence/absence of delirium in routine clinical notes. this under-recognition is largely the result of the length and complexity of available delirium diagnostic tools e.g. mini-mental state exam (mmse), although the perceived lack of clinical importance and conflicting results about specific treatment modalities also contribute. the investigators recently developed the simple 4-question "racy" delirium screening tool for use in general medical in-patients. preliminary data show the test to be simple and effective with a sensitivity and specificity of 78% and 85% respectively using a roc-selected cut-point of racy≤2. the investigators hypothesis that the racy screening tool has the potential to be a simple and effective bedside delirium diagnostic instrument for use in non-geriatric, busy general medical in-patient settings. this study is a two-centre validation study to evaluate the diagnostic accuracy of this tool.


Eligibility criteria:
inclusion criteria: * patients referred for admission to general medical wards (including within hospital transfer e.g. icu discharge) * \>18 years and willing to give informed consent exclusion criteria: * patient admitted directly to intensive care unit * patient refusing consent or \<18 years old * patients unable to undergo delirium testing due to: i) glasgow coma scale ≤ 12/15, ii) aphasia

Keywords: delirium
cardiopulmonary resuscitation in cases of sudden cardiac arrest

Conditions: Cardiac Arrest

Summary: determination the success rate of cpr on adults in emergency room and predicting the factors that makes cpr is successful.

cardiac arrest is a medical emergency that requires immediate cardiopulmonary resuscitation (cpr). return of spontaneous circulation (rosc) is a core outcome element of cardiopulmonary resuscitation (cpr) both in out-of-hospital cardiac arrest (ohca) and in-hospital cardiac arrest and has been considered a standard in the evaluation of successful resuscitation. rosc was defined as a clinical assessment that shows signs of life comprising of a palpable pulse for at least 20 minutes or generating a blood pressure, the duration of rosc is key element not only to the efficacy of the chain of survival but also to assess the success of resuscitation in emergency medical services (emss). worldwide cpr outcomes vary due to differences in the circumstances of cardiac arrest, availability of equipment, and performance of the cpr team. the influencing factors of cpr outcome at the emergency room (er) are patient characteristics, early detection, immediate cpr, initial shockable rhythm, duration of cpr of less than 10 minutes and advanced cardiac life support. in egypt, there has been scarce studies regarding cpr and studies that measure the success rate of cpr and factors determining its success. this study aims to assess the success rate of cpr in emergency room and factors predicting successful cpr on adults.

Eligibility criteria:
inclusion criteria: * resuscitated at the er in al hussein university hospital. * patients have experienced cardiac arrest. exclusion criteria: * patient arresting and receiving cpr inside hospital's other departments. * signs of sure death. * patient with multiple organ failure syndrome (m.o.f syndrome

Keywords: cpr success rate emergency medicine critical care icu and pain management
sequential conditioning in haploidentical transplantation for hematopoietic stem cells in patients with relapsed or refractory lymphoid hematological disorders

Conditions: Refractory or Relapsed Lymphoid Haemopathy

Summary: allogeneic hematopoietic stem cell transplantation (allo-hsct) is the only treatment option with a significant chance of healing in lymphoid hematological refractory or multiple relapses after chemotherapy. however, all patients with an indication of allo-hsc can not benefit because of two limitations: the toxicity of the treatment and graft shortage available. for patients refractory or in relapses with an indication of allo-hsc, used the combinaison of an set followed by the reduced-intensity allo-hsc (ric) has shown some interesting results. a post-transplant immune modulation with prophylactic injections of donor lymphocytes (pdli) showed its effectiveness to decrease the risk of relapse while having a lower toxicity than chemotherapy


Eligibility criteria:
inclusion criteria: * patients with an indication of allo-hsc for a lymphoid hematological malignancy like hodgkin's lymphoma, non hodgkin's lymphoma b cell (mantle follicular, diffuse large cells, marginal zone,malt) or t (peripheral t whithout specificity, anaplasic, angio-immunoblastic, natural killer cells, gamma / delta t cells, sezary's syndrome, primitive cutaneous t), prolymphocytic leukemia, chronic lymphocytic leukemia, waldenström's disease and for which a therapeutic strategie combining a sequential chemotherapy followed by the reduced-intensity conditioning(set ric + pdli) is decided * patients at least in partial response (standard criteria) after a rescue treatment the day of evaluation at 1 month before the conditioning * advanced age ≥ 18 to \<60 years * cardiac ejection fraction of the left ventricle ≥ 45% * lung function - free diffusion capacity for carbon monoxide ≥ 50% of predicted value * creatinine clearance ≥ 50 ml / min depending on the ckd-epi formula * availability of an hla haploidentical donor in the family * collection of non-opposition exclusion criteria: * invasion of uncontrolled cns * availability of an hla identical family donor who agreed to donate hematopoietic stem cells or non-related donor hla-compatible 10/10 on hla-a alleles, b, c, and drb1 dqb1 available and ready to give in 4 weeks to make a decision allograft * presence in the patient hla-specific antibodies directed against an antigen hla haploidentical donor family * karnofsky score \<70% * patient hiv positive * hepatitis b or c or chronic active * uncontrolled infection at the time of start packing * contraindication to the use of treatments provided by the protocol * previous history of allo-hsc * no beneficiary of a social security scheme. * life expentancy estimated less than 1 month by investigator

Keywords: allogenic cell stem transplant sequential chemotherapy haploidentical transplant
using the cholinergic anti-inflammatory pathway to treat systemic lupus musculoskeletal pain

Conditions: Lupus Erythematosus, Systemic; Musculoskeletal Pain

Summary: systemic lupus erythematosus (sle) is a chronic autoimmune, inflammatory disease and musculoskeletal pain is one of the most common symptoms. this study will investigate whether transcutaneous stimulation of the vagus nerve will decrease lupus musculoskeletal pain. this study will additionally investigate the biologic effects of vagus nerve stimulation on inflammation. it will be the first clinical study using one of the body's own pathways of modulating the immune system and inflammatory response, the cholinergic anti-inflammatory pathway, in sle.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years, 2. sle (defined by the acr or slicc criteria), 3. musculoskeletal pain ≥ 4 on a non-anchored vas 10 cm scale 4. bilag c on musculoskeletal domain of the bilag 2004 5. if on corticosteroids, the dose must be stable and ≤ 10mg/day (prednisone or equivalent) for at least 28 days before baseline, 6. if on background immunosuppressive treatment the dose must be stable for at least 28 days before baseline 7. able and willing to give written informed consent and comply with the requirements of the study protocol. exclusion criteria: 1. treatment with rituximab within one year of baseline (subjects with previous treatment with rituximab can enter study only with documentation of b cell repletion), 2. treatment with cyclophosphamide within 2 months of baseline, 3. expectation to increase steroids and/or immunosuppressive treatment, 4. anti-phospholipid syndrome, 5. fibromyalgia (fibromyalgia will be defined as a score \> 13 on the fibromyalgia symptom scale (fss). 6. treatment with an anti-cholinergic medication, including over the counter medications, 7. implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators. 8. current tobacco or nicotine user, 9. joint replacement within 60 days prior to study enrollment or planned within the course of the study, 10. any planned surgical procedure requiring general anesthesia within the course of the study, 11. intra-articular cortisone injections within 28 days of the start of study, 12. chronic inflammatory disorders apart from sle affecting the joints, 13. investigational drug and/or treatment during the 28 days or seven half-lives of the investigational drug prior to the start of study drug dosing (day 0), whichever is the greater length of time, 14. active infection including hepatitis b or hepatitis c at baseline, 15. any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to a study intervention, 16. pregnancy or lactation, 17. comorbid disease that may require administration of corticosteroid use, 18. inability to comply with study and follow-up procedures.

Keywords: lupus erythematosus, systemic musculoskeletal pain inflammation
a roll-over observational study for the extended follow-up of the volunteers of the iss t-003 trial

Conditions: HIV Infections

Summary: a roll-over observational study (iss t-003 ef-up) is being conducted to extend the follow-up of the volunteers of the iss t-003 trial in order to evaluate the persistence of vaccine immunogenicity as well as of the immunological and virological effects induced by the therapeutic immunization with tat.

an open label, non-interventional study roll-over study (iss t-003 ef-up) is being conducted to follow-up the persistence of vaccine humoral responses as well as of the immunological and virological effects induced by the therapeutic immunization with tat.to this aim volunteers of the iss t-003 study are included in one year study, with visits at weeks 0 and 24 and 54. to assess the anti-tat humoral immune response by the determination and titration of igm, igg and iga anti-tat antibodies (primary endpoint) and to evaluate cd4+ t cell counts and hiv-1 plasma viraemia (as secondary endpoint). in addition, depending on the availability of residual specimens (pbmc, serum and plasma), further laboratory tests (i.e. hiv dna copies in blood) to investigate in-depth the immunological and virological profile of the volunteers is being performed. physical examination is being performed to monitor the clinical status of the volunteers and to record the appearance of clinical signs and symptoms of disease progression as well as aids-defining events, data or records related to arv treatment compliance. pregnancy onset for female participants will also be recorded.

Eligibility criteria:
inclusion criteria: * previous participation in the iss t-003 trial without withdrawal of consent; * availability to participate in the extended follow-up study; * signed informed consent. exclusion criteria: * the absence of any of the above criteria will exclude the participants from the study

Keywords: haart-treated participants tat therapeutic immunization
long term health cohort of premature infants

Conditions: Preterm

Summary: establish a clinical diagnosis and treatment and long-term follow-up database of preterm infants, and analyze the effects of prenatal factors (including genetic characteristics, maternal diseases, etc.), postnatal diagnosis and treatment measures and family maintenance environment after discharge on preterm infant mortality and major diseases in the near and long term.

as an increasing large group, the long-term quality of life and health status of preterm infants have become a very important public health problem in china. this cohort study is a single center clinical cohort study. by collecting the clinical diagnosis, treatment and follow-up data of preterm infants admitted to the neonatal department of our hospital for 3 consecutive years (about 1200 cases), and following them for 18 years, a relatively complete resource database for the long-term health and development of preterm infants is established. the effects of perinatal factors, diagnosis and treatment methods and family rearing environment on the survival rate, neurointelligence development, chronic metabolic diseases and respiratory diseases of preterm infants were analyzed. it provides a basis for further improving the diagnosis and treatment plan, exploring potential therapeutic targets and establishing prediction models.

Eligibility criteria:
inclusion criteria: 1. live born newborns with gestational age ≤ 36 + 6 weeks 2. transfer to the neonatal ward of shanghai children's medical center within 24 hours after birth 3. those who have lived in shanghai for more than 1 year and plan to live in shanghai for a long time. parents voluntarily participated in the study and signed informed consent exclusion criteria: 1. premature infants: termination of treatment due to family factors (non-disease reasons) and hospitalization time ≤ 2 weeks 2. major congenital malformations 3. parents refuse to participate in the study
phase ii study of teriflunomide as adjunctive therapy to interferon-beta in subjects with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the primary objective was to estimate the tolerability and safety of 2 doses of teriflunomide administered once daily for 24 weeks, compared with placebo, in patients with multiple sclerosis \[ms\] with relapses who were on a stable dose of interferon-β \[ifn-β\]. secondary objectives were: * to estimate the effects of the 2 doses of teriflunomide, compared to placebo, in combination with a stable dose of ifn-β on magnetic resonance imaging \[mri\] parameters, relapse rate and patient-reported fatigue; * to perform pharmacokinetic analyses of the 2 doses of teriflunomide in combination with a stable dose of ifn-β.

the study period per participant was approximatively 44 weeks broken down as follows: * screening period up to 4 weeks, * 24-week double-blind treatment period\*, * 16-week post-treatment elimination follow-up period. '\*' participants successfully completing the week 24 visit were offered the opportunity to enter the optional long-term extension study lts6047 - nct00811395.

Eligibility criteria:
inclusion criteria: * definite ms diagnosis according to mcdonald's criteria; * relapsing clinical course, with or without progression; * expanded disability status scale \[edss\] less or equal to 5.5 (ambulatory); * stable dose of ifn-β for at least 26 weeks prior to the screening visit; * no onset of ms relapse in the preceding 60 days prior to randomization; * clinically stable for 4 weeks prior to randomization. exclusion criteria: * other chronic disease of the immune system, liver function impairment or chronic pancreatic disease; * pregnant or nursing woman; * alcohol or drug abuse; * use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment; * human immunodeficiency virus \[hiv\] positive status; * any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: ms interferon-beta adjunctive therapy relapses
pulmonary hypertension and oxygen saturation targeting in preterm infants

Conditions: Bronchopulmonary Dysplasia; Pulmonary Hypertension

Summary: around 50% of infants born extremely preterm develop a chronic lung disease known as bronchopulmonary dysplasia of which some infants will also develop pulmonary hypertension of which 50% of children will die before the age of 2. physicians are currently limited in their ability to select the most appropriate oxygen targets that will improve outcomes in infants with this condition. this clinical trial will determine whether using different amounts of oxygen improve outcomes in infants with this disease.

infants born between 22.0 to 31.6 weeks' gestational age with bronchopulmonary dysplasia associated pulmonary hypertension, are receiving supplemental oxygen, and have mature retinas will be randomized to spo2 targets of either (1) 92-95% (control) or (2) 95-98% (intervention). using a cross over design with a 1:1 parallel allocation of infants randomized using a stratified permuted block design. following 1week of exposure a, infants will cross over to exposure b for 1 week with a 1-week washout period. bedside providers will follow pre-specified algorithms to maintain oxygen targets during the randomization period. reports of oxygen saturation performance will also be provided to bedside providers through oxygen saturation histograms.

Eligibility criteria:
inclusion criteria: * between 22w 0/7d and 31w 6/7d gestation at birth * diagnosed with echocardiographic pulmonary hypertension (1) \>20% flow of blood across the pda from the pulmonary to arterial circulation, (2) end-systolic flattening of the interventricular septum (eccentricity index \>1.3), or (3) right ventricular pressure estimates ≥ 35 mm hg * receiving supplemental oxygen * have mature retinas exclusion criteria: * major congenital anomalies