Kornimate/medical-research-clean huggingface dataset:
protective ventilation with higher versus lower peep during general anesthesia for surgery in obese patients

Conditions: Morbid Obesity; Surgery; General Anesthesia

Summary: postoperative respiratory failure, particularly after surgery under general anesthesia, adds to the morbidity and mortality of surgical patients. anesthesiologists inconsistently use positive end-expiratory pressure (peep) and recruitment maneuvers in the hope that this may improve oxygenation and protect against postoperative pulmonary complications (ppcs), especially in obese patients. while anesthesiologists tend to use peep higher than in non-obese patients. while it is uncertain whether a strategy that uses higher levels of peep with recruitment maneuvers truly prevents ppcs in these patients, use of higher levels of peep with recruitment maneuvers could compromise intra-operative hemodynamics. the investigators aim to compare a ventilation strategy using higher levels of peep with recruitment maneuvers with one using lower levels of peep without recruitment maneuvers in obese patients at an intermediate-to-high risk for ppcs. we hypothesize that an intra-operative ventilation strategy using higher levels of peep and recruitment maneuvers, as compared to ventilation with lower levels of peep without recruitment maneuvers, prevents ppcs in obese patients at an intermediate-to-high risk for ppc.


Eligibility criteria:
inclusion criteria: * patient scheduled for open or laparoscopic surgery under general anesthesia * intermediate-to-high risk for ppcs following surgery, according to the ariscat risk score (≥ 26) * bmi ≥ 35 kg/m2 * expected duration of surgery ≥ 2 h exclusion criteria: * age \< 18 years * previous lung surgery (any) * persistent hemodynamic instability, intractable shock (considered hemodynamically unsuitable for the study by the patient's managing physician) * history of previous severe chronic obstructive pulmonary disease (copd) (non-invasive ventilation and/or oxygen therapy at home, repeated systemic corticosteroid therapy for acute exacerbations of copd) * recent immunosuppressive medication (patients receiving chemotherapy or radiation therapy up to two months prior to surgery) * severe cardiac disease (new york heart association class iii or iv, acute coronary syndrome or persistent ventricular tachyarrhythmias) * invasive mechanical ventilation longer than 30 minutes (e.g., general anesthesia for surgery) within last 30 days * pregnancy (excluded by anamneses and/or laboratory analysis) * prevalent acute respiratory distress syndrome expected to require prolonged postoperative mechanical ventilation * severe pulmonary arterial hypertension, defined as systolic pulmonary artery pressure \> 40 mmhg * intracranial injury or tumor * neuromuscular disease (any) * need for intraoperative prone or lateral decubitus position * need for one-lung ventilation * cardiac surgery * neurosurgery * planned reintubation following surgery * enrolled in other interventional study or refusal of informed consent
rd13-02 cell injection in patients with relapsed or refractory cd7-positive natural killer/t cell malignancies

Conditions: NK T-Cell Lymphoma; CART Therapy; CD7-positive Relapsed/Refractory Lymphoid Hematologic Malignancies

Summary: this is a single-arm, open-label, single-center, phase i study. the primary objective is to evaluate the safety of cd7 chimeric antigen receptor-t(car-t) therapy for patients with cd7-positive relapsed or refractory natural killer/t cell lymphoma, and to evaluate the pharmacokinetics of cd7 car-t in patients。


Eligibility criteria:
inclusion criteria: 1. age 3-70 2. diagnosis of r/r nk/t lymphoma. 3. cd7 positive expression 4. bone marrow lymphoblasts ≥5% by morphologic evaluation at screening 5. creatinine clearance (as estimated by cockcroft gault) ≥ 60 ml/min, serum alanine aminotransferase(alt)/aspartate aminotransferase(ast) \< 3×upper limit of normal, total bilirubin \< 1.5×upper limit of normal or ≤1.5mg/dl 6. left ventricular ejection fraction ≥ 50% . 7. baseline oxygen saturation ≥ 92% on room air. 8. eastern cooperative oncology group (ecog) performance status of 0 to 2. 9. the estimated survival time is more than 3 months. 10. subjects or their legal guardians volunteer to participate in the study and sign the informed consent. exclusion criteria: 1. subjects with concomitant genetic syndromes associated with bone marrow failure states. 2. isolated extramedullary lesions 3. subjects with some cardiac conditions will be excluded. 4. with uncontrolled active central nervous system leukemia (cnsl), cerebrospinal fluid grade central nervous system3(cns3). 5. history of traumatic brain injury, consciousness disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic disease, which might compromise the ability of the subject to compliance with the obligations under the protocol. 6. history of malignancy other than non-melanoma skin cancer or carcinoma. 7. primary immune deficiency. 8. presence of uncontrolled infections. 9. subjects with some anticancer therapy before car-t infusion will be excluded. 10. active uncontrolled acute infections. 11. known history of infection with human immunodeficiency virus (hiv); active or latent hepatitis b, hepatitis c and syphilis. 12. subjects who are receiving systemic steroid therapy prior to screening.
phase i/ii randomized study of hydroxyurea with or without clotrimazole in patients with sickle cell anemia

Conditions: Sickle Cell Anemia

Summary: objectives: i. compare the efficacy of hydroxyurea with or without clotrimazole in terms of limiting the severity of anemia and the rate of hemolysis in patients with sickle cell anemia.

protocol outline: this is a randomized study. patients are randomized to one of two treatment arms. arm i: patients receive oral hydroxyurea and oral clotrimazole daily for 12 months. arm ii: patients receive oral hydroxyurea daily for 12 months. patients are followed at 6 weeks. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
protocol entry criteria: --disease characteristics-- diagnosis of sickle cell anemia confirmed by hemoglobin electrophoresis received hydroxyurea for at least 6 months on a stable dose for at least 3 months tolerating dose of at least 5 mg/kg/day --prior/concurrent therapy-- chemotherapy: * no other concurrent antisickling agent other: no concurrent drug that may interact with or influence the metabolism of hydroxyurea or clotrimazole --patient characteristics-- hematopoietic: wbc at least 4000/mm3 platelet count at least 150,000/mm3 hemoglobin less than 11 g/dl hepatic: ast/alt no greater than 100 units/l renal: creatinine no greater than 1.5 mg/dl other: * not pregnant or nursing * fertile patients must use effective contraception * no prior adverse reaction to hydroxyurea or clotrimazole * no recent or progressive neurologic dysfunction

Keywords: genetic diseases and dysmorphic syndromes hematologic disorders rare disease sickle cell anemia
expanded natural killer cells following haploidentical hsct for aml/mds

Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndromes

Summary: the study examines the application of expanded natural killer cells (nk cells) following haploidentical allogeneic hematopoietic stem cell transplantation (haplo-hsct) for aml or mds. haplo-hsct is a preferred treatment option for patients with aml or mds without a hla-matched donor. with administration of cyclophosphamide post-transplant , the safety of the procedure is similar to a hsct from a hla-identical donor. relapse of aml/mds represents a serious problem following haplo-hsct. nk cells are immune cells able to destroy tumor cells. their potency has been established particularly in the setting of a haplo-hsct. in the current study, study participants undergoing haplo-hsct will receive expanded nk cells from their respective stem-cell donors following haplo-hsct. the primary goal of the study is to establish the safety and feasibility of this approach. in addition, the activity of the nk cells will be examined.


Eligibility criteria:
inclusion criteria: patient: * \>18 years of age * no hla-matched related or unrelated donor available * aml or mds-eb with indication for a haplo-hsct according to the guidelines of the university hospital basel stem cell transplant team * judged by the transplant physicians to have adequate organ function and no contraindications to haplo-hsct * available related haploidentical donor * written informed consent donor: * \>18 years old, haploidentical parent, sibling or other relative * donor suitable for cell donation and apheresis according to standard criteria * written informed consent exclusion criteria: patient: * apl diagnosis * presence of relevant (mean fluorescence intensity \>2000) donor-specific anti-hla antibodies * pregnancy * necessity of immunosuppression apart from gvhd prophylaxis exclusion criteria: donor: • pregnancy

Keywords: natural killer cells nk cells immunotherapy haploidentical hematopoietic stem cell transplantation
lifestyle intervention in obstructive sleep apnoea

Conditions: Obstructive Sleep Apnoea; Obesity

Summary: obstructive sleep apnoea/hypopnoea syndrome (osahs) is a common disorder characterised by interrupted breathing while sleeping. it is associated with cardiovascular problems such as high blood pressure, heart attack and stroke. furthermore, most patients with osahs are overweight and have impaired quality of life. lifestyle interventions incorporating exercise training, dietary advice and behaviour change have been shown to elicit favourable changes in quality of life, body mass/composition and cardiovascular risk in a range of patient groups. however, no study has investigated the impact of lifestyle modification on such health outcomes in patients with osahs. this study will address this issue by investigating the effects of a lifestyle intervention on quality of life, body mass/composition and cardiovascular risk in patients with osahs. a total of 60 volunteers will be recruited and randomly allocated to one of the two groups. patients in the intervention group will be offered a 12-week individualised lifestyle programme consisting of supervised exercise training, dietary advice and behaviour change counselling. patients in the control group will receive an educational booklet detailing healthy eating and exercise guidelines but no supervised or structured intervention. the results of this study will inform the design of a larger, multi-centre randomised controlled trial.


Eligibility criteria:
inclusion criteria: * obstructive sleep apnoea patients who have been receiving cpap therapy for at least 6 months and are known to be adherent to the treatment (\>75% nightly use per week) * clinically obese (body mass index \>30) * age 18-85 years * able to undertake exercise testing and training exclusion criteria: * patients with any contraindications to exercise (e.g. severe hypertension, unstable arrhythmias, severe musculoskeletal injuries) * unable to undertake the requirements of the study * non-english speaking * already undertaking \>30 min exercise \>3 times per week * non-compliant with cpap * body mass index \<30 * unable to provide written informed consent

Keywords: exercise diet lifestyle sleep apnoea obesity
al18f-psma-617 and 68ga-psma-617 pet/ct imaging in the same group of prostate cancer patients

Conditions: Prostate Cancer

Summary: 18f-labeled prostate-specific membrane antigen (psma) ligand-positron emission tomography (pet) offers advantages over 68ga-labeled psma ligands. al18f-psma-617 is a novel 18f-psma compound used for prostate cancer (pca) imaging. this pilot study was prospectively designed to compare the lesion detectability of al18f-psma-617 and related 68ga-psma-617 pet/ct in patients with pca

prostate cancer (pc) is one of the most common malignancies worldwide in men, with persistently high numbers dying from this disease. due to low levels of glycolysis in prostate cancer cell, the uses of 18f-fdg pet/ct to detect prostate cancer and its metastases are limited. prostate specific membrane antigen (psma), as known as folate hydrolase i or glutamate carboxypeptidase ii, is overexpressed on the cells of prostatic adenocarcinoma. various low molecular weight radiopharmaceuticals targeting psma such as psma-617, psma-11 for 68ga-labeling have been developed. 68ga-psma pet/ct has demonstrated desirable sensitivity and specificity in the detection of prostate cancer lesions, which can find many micro lesions that cannot be identified by ct, mri and bone scan. al18f-psma-617 is a novel radiopharmaceutical targeting psma. liu t et.al had demonstrated that al18f-psma-617 accumulates specifically in psma-positive tumors with high binding affinity and selectivity. the first in-human evaluation of al18f-psma-617 in a small pca sample size also confirmed the good detectability of tumor lesions. this pilot study was prospectively designed to evaluate the early dynamic distribution of al18f-psma-617 compared with 68ga-psma-617 in the same group of prostate cancer patients.

Eligibility criteria:
inclusion criteria: * confirmed untreated prostate cancer patients; * 68ga-psma617 and al18f-psma-617 pet/ct within two consecutive days; * signed written consent. exclusion criteria: * known allergy against psma; • any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
renal denervation in patients with advanced heart failure

Conditions: Heart Failure

Summary: sympathetic system has important role occurrence of symptoms in heart failure. renal denervation that is ablated some of sympathetic nerves is affected pathology of heart failure. this interventional therapy improves symptoms and life quality.

primary outcome measures: • safety of renal denervation in heart failure patients as measured by adverse events secondary outcome measures: • ventricular function,nyha functional class, 6 min walking test, biochemical test and renal function as measured by glomerular filtration rate (gfr) eligibility patients population: volunteers, nyha class iii-iv heart failure patients. ages eligible for study: 18 years to 85 years genders eligible for study: both accepts healthy volunteers: no

Eligibility criteria:
inclusion criteria: * heart failure patients nyha class iii or iv * left ventricular ejection function \< 35% * gfr \> 45 ml/min/1.73m2 * optimal stable medical therapy exclusion criteria: * do not eligible renal artery anatomy for treatment as determined by angiography, and * history of prior renal artery intervention * single functioning kidney. * myocardial infarction, unstable angina pectoris or cerebrovascular accident within 3 months * systolic bp \< 110mmhg hospitalisation because of heart failure in last 3 weeks.

Keywords: renal denervation heart failure
does hormonal luteal support after intra-uterine insemination (iui) increase the pregnancy rate?

Conditions: Subfertility

Summary: a randomized study to investigate if hormonal luteal support after intra-uterine insemination (iui) in ovulation induction cycles with human menopausal gonadotropin increases the pregnancy rate


Eligibility criteria:
inclusion criteria: * signed informed consent * tubal patency demonstrated * ovulation induction with human menopausal gonadotropin exclusion criteria: * ovulation induction with clomiphene citrate

Keywords: subfertility pregnancy rate miscarriage
in vivo study of neuroinflammation in tobaccosmoking: a clinical pet study of tspo using [18f]pbr111

Conditions: Dosimetry; Healthy

Summary: tobacco smoking is associated with multiple and well-recognized adverse health effects. however, the direct effects of smoking on the brain are less well understood. on of the mechanisms that could be associated with tobacco-related brain toxicity is neuroinflammation. pet/ct imaging constitutes an excellent means of assessment of neuroinflammation in vivo, with the quantification of tspo using \[18f\]pbr111. nonetheless, this radiopharmaceutical has not been authorized for human use in switzerland.

our study thus includes two parts. part a involves a dosimetry study (i.e. measure the exposure of the body organs of healthy individuals to radioactivity after the administration of 200 mbq of \[18f\]pbr111. this is a prerequisite for the authorization of the use of this radiotracer in humans. next, the main part of this study (part b) involves the comparison of the quantity of tspo in the brain of otherwise healthy smokers and age- and sex-matched non-smokers. part a: primary objective: to establish the exposure of the organs/tissues to a standard radioactive dose (200 mbq) of \[18f\]pbr111.

Eligibility criteria:
inclusion criteria: * aged ≥18 (3 male and 3 female participants) * fluent in french and able and willing to provide written informed consent. exclusion criteria: * homozygosity for the rs6971 polymorphism on tspo that results in low-affinity binding. this criterion is added because this polymorphism alters significantly the ability of the radiotracer \[18f\]pbr111 to bind to tspo, hence precluding quantification. * absence of a stable contraceptive regimen (specifically, intrauterine contraceptive device or contraceptive treatment per os). only women with stable contraception will be added to eliminate the risk of exposure of pregnant women and their foetus to radioactivity. * presence of any significant history or current diagnosis of chronic disease or syndrome (including neurological, psychiatric, cardiovascular, oncological, metabolic, rheumatological conditions). * one or more episode(s) of acute infectious or allergic reaction in the last month before inclusion and during the study period. again, we cannot exclude that such conditions might produce immune alterations in the brain, thus confounding the results of tspo quantification with \[18f\]pbr111. * presence of clinically relevant laboratory abnormalities in the haematological and biochemical blood tests, as defined as laboratory values that require clinical workup and/or treatment (e.g. anaemia, hyperglycaemia, electrolyte imbalances) * a body mass index \ 30 (this criterion is necessary because tspo has been shown to be variable with respect to body mass index (113-115)). * exposure to research related radiation in the past five years that, when combined with this study, would place subjects above the allowable limits. * conditions precluding entry into the scanners (e.g. claustrophobia).
safety study of replagal® therapy in children with fabry disease

Conditions: Fabry Disease

Summary: the purpose of this study is to assess the safety of replagal in children with fabry disease who who have not previously been treated with enzyme replacement therapy (ert).

in 2008, a change in the agalsidase alfa drug substance manufacturing process was made. there are no changes to the drug product formulation, manufacturing site, manufacturing process, or container closure. an agalsidase alfa bioreactor manufacturing process (agalaf1) utilizing animal component-free media replaced the previous roller bottle (rb) process. this study will evaluate the safety of replagal af, manufactured using the new bioreactor process at a dose of 0.2 mg/kg infused iv over 40 minutes, every other week (eow) in children with fabry disease who are 7 years to less than 18 years of age and who are naive to ert.

Eligibility criteria:
inclusion criteria: patients must meet all of the following criteria to be enrolled in this study. 1. all patients must be diagnosed with fabry disease by the following criteria: * male patients: the patient is a hemizygous male with fabry disease as confirmed by a deficiency of alfa-galactosidase a activity measured in serum, leukocytes, or fibroblasts or has a confirmed mutation of the alfa-galactosidase-a gene. * female patients: the patient is a heterozygous female with fabry disease as confirmed by a mutation of the alfa-galactosidase a gene. note: if the diagnosis of fabry disease is previously documented in the patient's medical record, screening tests do not need to be repeated. 2. the patient is 7 to \<18 years of age 3. the patient is ert-naïve 4. adequate general health (as determined by the investigators) to undergo the specified phlebotomy regimen and protocol-related procedures and no safety or medical contraindications for participation 5. the minor child must assent to participate in the protocol and the parent(s) or legally authorized representative(s) must have voluntarily signed an institutional review board/independent ethics committee (irb/iec) approved informed consent form after all relevant aspects of the study have been explained and discussed with the child and the child's parent(s) or legally authorized representative(s) exclusion criteria: patients who meet any of the following criteria will be excluded from the study. 1. patient and/or the patient's parent(s) or legally authorized representative(s) are unable to understand the nature, scope, and possible consequences of the study 2. patient is unable to comply with the protocol, eg, uncooperative with protocol schedule, refusal to agree to all of the study procedures, inability to return for evaluations, or is otherwise unlikely to complete the study, as determined by the investigator or the medical monitor. 3. otherwise unsuitable for the study, in the opinion of the investigator.

Keywords: agalsidase alfa replagal enzyme replacement therapy