Kornimate/medical-research-clean huggingface dataset:
preoperative warming, hypothermia and functional recovery in total hip arthroplasty

Conditions: Hypothermia Following Anesthesia; Hypothermia; Anesthesia

Summary: this prospective, randomized, single-center study compares intraoperative heat loss at the core temperature level in patients scheduled for direct anterior total hip arthroplasty under general anesthesia and who will or will not, according to randomization, receive one hour of pre-warming with a pulsed air thermal blanket prior to anesthesia induction.

in patients undergoing surgery, intraoperative hypothermia can occur because of anesthesia-induced inhibition of thermoregulation and heat loss associated with the patient's exposure to an environment maintained at a temperature below normal skin temperature. randomized trials show that even mild hypothermia results in serious complications, including surgical wound infection, coagulopathy and increased blood transfusions, and delayed postoperative recovery. all products used during general anesthesia profoundly alter thermoregulatory control, reducing the activation thresholds of the main defenses against cold, which are the closure of the arteriovenous shunt and the generation of shivering. impaired thermoregulation, combined with a cold operating room environment and direct-anterior hip surgical approach and exposure, causes hypothermia in almost all unheated patients. the body core temperature is finely tuned to maintain an average of 37°c by balancing heat gain and loss. the nasopharynx is an excellent alternative to patient core temperature monitoring when esophageal monitoring is excluded for surgical reasons or blocked by an airway protected by an airway device.

Eligibility criteria:
inclusion criteria: * asa 1-2-3 * scheduled for direct anterior-approached total hip replacement surgery under general anesthesia exclusion criteria: * pregnant women * patients with: 1. peripheral neuropathy or other severe neurological pathology 2. immunosuppression 3. chronic renal insufficiency or severe hepatic insufficiency 4. major congenital or acquired hemostasis disorders 5. craniofacial dysmorphism or anatomical alterations of the upper airways 6. known thermoregulatory disorders * patients with a preoperative body temperature \> 37.5°c.
mortality and risk factors in patients with acute cardiogenic pulmonary edema: a multicentric, observational, prospective study

Conditions: Pulmonary Edema; Respiratory Insufficiency

Summary: the purpose of this study is to define the current treatment of patients ospitalized with acute cardiogenic pulmonary edema. clinical and laboratory data collected in the emergency department will used to investigate the primary outcome (mortality) and risk factors related to the primary outcome.

acpe is a common cause of presentation to the emergency department (ed). early recognition of high-risk patients could help in better locating human and technical resources and in deciding adequate treatment and site of care. the investigators planned a real life, multicentric, prospective, web-based observational study performed in italian emergency departments. the investigators enroll consecutive patients admitted to the emergency department with acute cardiogenic pulmonary edema, that is defined as all the following: respiratory distress, bilateral rales and congestion on chest x-ray. demographic, clinical and laboratory findings are collected on admission and during hospitalization to evaluate mortality and risk factors related to mortality.

Eligibility criteria:
inclusion criteria: all of the following: * age ≥ 18 * acute-onset dyspnea * widespread pulmonary rales * pulmonary congestion on chest x- ray plus one of the following: * respiratory distress * respiratory rate ≥ 30 * emogasanalysis: ph \ 45 mmhg in venturi-mask 50%

Keywords: acpe acute respiratory failure non invasive ventilation acute cardiogenic pulmonary edema
effectiveness of two maxillary expanders in improving the transverse skeletal and dental dimensions in patients with cleft lip and palate

Conditions: Cleft Lip and Palate; Maxillary Expansion

Summary: this randomized controlled trial is designed to compare between quadlelix appliance vs hyrax expander regrading the their effectiveness in maxillary expansion in patients with cleft.


Eligibility criteria:
inclusion criteria: * mixed dentition stage; * both males and females; * lip repair performed between 3 and 6 months of age and palate repair performed between 12 and 24 months of age; * presence of maxillary constriction and posterior crossbite and need for maxillary expansion previous to the secondary bone graft; * permanent first maxillary molars present; * good periodontal health; * no previous orthodontic treatment; and exclusion criteria: * presence of a syndrome in companion with the present cleft defect. * previous secondary alveolar bone grafting. * taking medications affecting growth.
cd19-targeted car-t cell therapy for mrd+ b-cell malignancies after autologous stem cell transplantation

Conditions: Lymphoma, B-Cell; Leukemia, B-Cell; Minimal Disease, Residual

Summary: the main purpose of this study is to explore the efficacy of cd19-targeted car-t cell therapy for minimal residual disease (mrd) in b-cell malignancies after autologous stem cell transplantation.

relapse is a common cause of failure in patients with b-cell malignancies after autologous stem cell transplantation. cd19-targeted car-t cells showed excellent therapeutic efficiency in b-cell malignancies. investigators attempt to treat minimal residual disease (mrd)-positive b-cell malignancies after autologous stem cell transplantation by cd19-targeted car-t cells and hope to explore the therapeutic effects of cd19-targeted car-t cell therapy.

Eligibility criteria:
inclusion criteria: 1. confirmed by pathological biopsy in patients with b-cell malignancies and treated by autologous stem cell transplantation. 2. age 18 to 75 years old, both male and female; 3. is expected to survive more than 3 months; 4. physical condition is good: ecog score≤2; 5. in group of four weeks before canon imaging examination evaluation body tumor load, recommend line pet - ct examination. 6. general requirements autologous as basic, normal blood t lymphocytes in autologous count must \>= 0.2 x10\^9 / l; 7. no obvious abnormal heart, liver, kidney, no large wounds that haven't healed on the body; 8. into groups to participate in voluntarily, good adherence, can cooperate test observation, childbearing age women must be 7 days before starting treatment expert pregnancy test and the results were negative, and signed a written informed consent form. exclusion criteria: 1. organ failure, such as heart: class iii and iv; liver: to child grading of liver function grade c; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: disorder of consciousness; 2. existing serious acute infection, uncontrollable, or have fester sex and chronic infection, wound in delay no more; 3. patients with significant graft versus host disease (gvhd) after organ transplant history or allogeneic hematopoietic stem cell transplantation; 4. systemic autoimmune diseases or immunodeficiency disease, patients with allergic constitution; 5. coagulation abnormalities and severe thrombosis; 6. pregnancy and lactation women; 7. any other chronic disease patients who have been treated with immune agents or hormone therapy; 8. patients who have participated in other clinical trials or other clinical trials in the past 30 days; 9. the investigator believe the patients should not participate in this experiment.

Keywords: car-t minimal residual disease b cell maliganacy
trial to evaluate erectile function, fertility and sperm count in male cyclists compared to age matched controls

Conditions: Erectile Dysfunction; Azoospermia

Summary: bicycle riding is associated with related diverse urogenital symptoms ranging from genital numbness to erectile dysfunction (ed). very little is known about the quality of sperm in cyclists and whether a connection exists between erectile dysfunction and azoospermia.


Eligibility criteria:
inclusion criteria: * males ages 20-35, with at least 2 years of bicycle riding, at least 2 hours a week. exclusion criteria: * history of prostatic surgery, testicular surgery, or single testis, * patients after chemotherapy, * patients receiving hormonal therapy, * patients receiving alpha blockers for any indication.

Keywords: cyclist
the risk factors of thrombosis in complicated arteriovenous fistula

Conditions: Arteriovenous Fistula Thrombosis

Summary: study the risk factors of thrombosis in thrombosed arteriovenous fistula in patients on regular hemodialysis

the number of patients being treated for kidney failure continues to increase every year at a significantly higher rate than that of the world population. the main renal replacement therapy was hemodialysis (hd) in 57% patients and peritoneal dialysis in 5% patients, while 37% patients underwent a functional kidney transplant. native arteriovenous fistula (avf) is currently the best va when technically feasible, according to the international dialysis guidelines. hemodialysis vascular access failure is the dominant cause of morbidity and the major cost of care for end-stage renal disease (esrd) patients . complications such as thrombosis of va remain the main problem for many patients with kidney failure. since 1994, prospective and case-control studies have explored the relationship between risk factors and arteriovenous fistula thrombus (avft) in patients undergoing hd . until now, these studies and reviews have revealed that numerous risk factors are associated with avft . risk factors like arterio-venous graft, age, female sex, c-reactive protein level, fistula site (distal), hypertension and the use of eprex can be associated with avft, and this knowledge advances the understanding of avft, facilitates multivariable risk prediction profiling, and lays the foundation for future preventive strategies .

Eligibility criteria:
inclusion criteria: * all patients on maintenance hemodialysis treatment at the dialysis unit of the department of nephrology in assiut university hospital . exclusion criteria: * patients with known other risk factors of thrombosis, e.g., malignancy, pregnancy, cocs and nephrotic syndrome.
amsterdam investigator-initiated absorb strategy all-comers trial

Conditions: Coronary Artery Disease; Myocardial Infarction

Summary: to evaluate the efficacy and performance in an all-comers contemporary population of the absorb bioresorbable vascular scaffolds (bvs) strategy versus the xience family (xience prime or xience xpedition) everolimus eluting coronary stent system in the treatment of coronary lesions.

the aida trial is a prospective, randomized (1:1), active control, single blinded, four-center, all-comers, non-inferiority trial. a total of 1845 patients were enrolled. the study population includes both simple and complex lesions, as well as stable and acute coronary syndrome patients. the follow-up will continue for 5 years including clinical endpoint characteristics.

Eligibility criteria:
inclusion criteria: * subject is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions and the instructions for use of the absorb bvs strategy and xience family. * subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the absorb bvs strategy and he/she or his/her legally authorized representative provides written informed consent prior to any clinical investigation related procedure, as approved by the appropriate ethics committee. exclusion criteria: * subject is younger than 18 years of age * subject has a true bifurcation lesion where a priori two scaffold/stent strategy is planned. * unsuccessful predilation of one or more of the planned lesion to be treated. * planned treatment of in-stent restenosis of a previously placed metallic stent. * subject has one or more lesion planned to be treated with a scaffold/stent diameter size smaller than 2.5 mm or greater than 4.0 mm. * subject has one or more lesion planned to be treated with a stent/scaffold length greater than 70 mm and/or overlapping of four or more scaffolds/stents. * subject has known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel, prasugrel and ticagrelor, inclusive), everolimus, poly (l-lactide), poly (dl-lactide), cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated. * subjects pregnant or nursing subjects and those who plan pregnancy in the period up to 2 years following index procedure. (female subjects of child-bearing potential must have a negative pregnancy test done within 28 days prior to the index procedure and contraception must be used during participation in this trial) * subjects with a limited life expectancy less than one year. * subjects with factors that impede clinical follow-up (e.g. no fixed abode). * subject is already participating in another clinical investigation that has not yet reached its primary endpoint. * subject is belonging to a vulnerable population (per investigator's judgment, e.g., subordinate hospital staff or sponsor staff) or subject unable to read or write.
corrective osteotomy of the distal radius without bone grafting

Conditions: Distal Radius Fracture

Summary: the investigators retrospectively analyzed patients who underwent extraarticular corrective osteotomy of the distal radius via a palmar approach and without the use of a bone graft, even in the absence of cortical contact after corrective osteotomy. the goal of this retrospective observational study is to determine whether secondary dislocation or nonunion occurs after corrective osteotomy without bone grafting.


Eligibility criteria:
inclusion criteria: * malunited distal radius fracture * extraarticular corrective osteotomy * palmar approach * no bone graft used * no cortical contact after dorsal open wedge osteotomy * signed informed consent exclusion criteria: * others reasons for malunion * intraarticular corrective osteotomy * use of a bone graft * cortical contact after open wedge osteotomy * lost to follow up
mazindol in children with adhd : open-label, efficacy, safety and pharmacokinetic pilot trial

Conditions: Attention Deficit Hyperactivity Disorder

Summary: this prospective pilot trial will evaluate the efficacy, safety, tolerability and pharmacokinetic (pk) and pharmacodynamic (pd) properties of mazindol.

the most common intervention for attention deficit hyperactivity disorder (adhd) is pharmacological treatment with methylphenidate (mph). effects of mph on adhd symptoms in children is extremely well-informed. mazindol is a psychostimulant and a wake-promoter agent which may have similar actions to mph in the central nervous system. however, there is no record of the effects, safety, tolerability of mazindol in children with adhd. mazindol (dose 0.5 or 1.0 mg/day) should prove to be useful in the treatment of adhd symptoms in children. based on clinical assessments and serum concentrations after oral administration of mazindol to children (6-12 years) with adhd, this prospective pilot trial will evaluate the efficacy, safety, tolerability and pharmacokinetic (pk) and pharmacodynamic (pd) properties of mazindol.

Eligibility criteria:
inclusion criteria: * subjects can be boys or girls * subjects must be aged between 6 to 12 years, * tanner 1 ou 2 * subjects with a diagnosis of adhd according to the diagnostic and statistical manual of mental diseases, fourth edition (dsm-iv) criteria * adhd-rs score of ≥ 31 as determined by investigator at screening visit. * drug free including psychostimulants (10 days before the screening visit) * informed consent form signed by the subject and both parents * healthy on the basis of a physical examination, medical history and the results of blood hematology tests. exclusion criteria: * any clinically unstable psychiatric condition including, but not limited to the following: acute mood disorder, bipolar disorder, obsessive-compulsive disorder (ocd), autism or asperger... * sleep disorders including narcolepsy, hypersomnia (according to international classification of sleep disorders (icsd) criteria * chronic diseases (e.g. asthma...) * current eating disorder (e.g. bulimia, anorexia nervosa) or history of an eating disorder during infancy * mental retardation (iq \< 80) * hyperthyroidism * subjects with history of seizures, glaucoma or familial hypertension * heart pathologies

Keywords: attention deficit hyperactivity disorder mazindol
maintenance bevacizumab or observation after taxane based first line chemotherapy in metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: investigators propose to assess,the safety and tolerability profile (number of participants with adverse events)of bevacizumab (avastin) when combined with standard chemotherapy as first line treatment of patients with metastatic breast cancer.

nowadays in clinical practice patients with previously untreated metastatic breast cancer often receive taxane-based chemotherapy (paclitaxel or docetaxel) in combination with bevacizumab as it has been shown to increase progression-free survival. there is currently minimal information whether bevacizumab should be given as maintenance therapy after discontinuation of chemotherapy.

Eligibility criteria:
inclusion criteria: * written informed consent * age ≥18 years * patients with histologically or cytologically confirmed, her2-negative, metastatic breast cancer * no prior first line treatment for metastatic breast cancer * previous hormonotherapy for metastatic breast cancer is allowed * one or more measurable lesions (≥1cm in diameter with spiral ct scan or ≥2cm with conventional techniques) according to recist criteria * ecog performance status ≤2 * adequate haematological, renal and hepatic function * urine protein \<2+ (dipstick) * life expectancy of ≥12 weeks exclusion criteria: * previous first line treatment for metastatic colorectal cancer(progression \>12 months after the end of adjuvant treatment) * previous radiotherapy to target lesions * patients with brain metastases and/or cancerous meningitis * presence or history of other neoplasm except properly treated basal cell skin cancer or in situ cervical carcinoma * patients participating in interventional clinical trial

Keywords: mbc her2 negative chemotherapy anti-angiogenic agent bevacizumab 1st line
prevalence of peripheral arterial disease in subject with a moderate risk of cardiovascular (cv) disease (cvd) in primary prevention

Conditions: Peripheral Arterial Disease (PAD); Moderate Risk for Cardiovascular Disease (CVD)

Summary: non interventional study aimed to establish the prevalence of lower extremity peripheral arterial disease (pad), defined as an ankle-brachial index (abi) not above 0.90 in subjects with a moderate risk of cardiovascular disease, with no overt cardiovascular diseases nor diabetes mellitus.


Eligibility criteria:
inclusion criteria: * male subject aged 45 years or above, or female subject aged 55 years or above (age-related cvd risk factor) * at least another of the following risk factor for cvd: cigarette smoking, hypertension, low hdl cholesterol or high ldl cholesterol, family history of premature coronary heart disease, elevated waist circumference * willingness to participate in the survey and complying with the study by signing a written informed consent exclusion criteria: * no or 1 risk factor for cvd; symptoms of pad; diabetes mellitus; coronary heart disease or equivalents * no lipid data collected in the last 12 months * serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study; unwilling or unable to provide informed consent

Keywords: peripheral arterial disease (pad) cardiovascular disease (cvd) atherosclerotic cardiovascular disease atherosclerosis primary cvd prevention
pancreatic head resection or total pancreatectomy with islet autotransplantation in patients with periampullary cancer and high risk profile for the development of postoperative pancreatic fistula

Conditions: Periampullary Cancer; Postoperative Pancreatic Fistula

Summary: the primary objective of this clinical trial is to evaluate whether primary total pancreatectomy with simultaneous islet autotransplantation compared with pancreatic head resection (alone) can reduce perioperative morbidity and time to initiation of adjuvant therapy in patients with a high-risk constellation for pancreatic fistulas.


Eligibility criteria:
inclusion criteria: * suspected or confirmed periampullary carcinoma (tumor) and indication for pppd (pylorus-preserving pancreaticoduodenectomy) or whipple surgery * high-risk profile for the development of a postoperative pancreatic fistula (popf) after pancreatic head resection: soft pancreas and pancreatic duct diameter \< 3 mm (preoperative and intraoperative confirmation) * written informed consent of the participant after successful informed consent exclusion criteria: * patients on whom another procedure is to be performed simultaneously in addition to pppd or whipple surgery * confirmed other primary tumor * previous transplantation of an organ or tissue * known infection with hiv (hiv antibodies) * positive hepatitis c antibodies, positive hepatitis b surface antigens and hepatitis bc antibodies * insulin-treated diabetes mellitus * history of hypersensitivity to any of the drugs used or their ingredients or to drugs with a similar chemical structure * concurrent participation in another clinical trial (incl. within the last 4 weeks prior to inclusion). * addiction or other medical conditions that do not allow the subject to understand the nature and not be able to appreciate the nature, scope and possible consequences of the trial * pregnant or breastfeeding women * women of childbearing age, except for women who meet the following criteria: 1. post-menopausal (12 months of natural amenorrhea or 6 months of amenorrhea with serum fsh \> 40 u/ml) 2. post-operative (6 weeks after bilateral ovariectomy with or without hysterectomy) 3. regular and correct use of a contraceptive method with an failure rate \< 1% per year 4. sexual abstinence 5. vasectomy of the partner * evidence that the patient is unlikely to comply with the protocol