Kornimate/medical-research-clean huggingface dataset:
flow controlled ventilation in thoracic surgery

Conditions: Positive-Pressure Respiration, Intrinsic

Summary: this trial investigates effects of individualized (by compliance guided pressure settings) flow-controlled ventilation compared to best clinical practice pressure-controlled ventilation in thoracic surgery requiring one lung ventilation.

flow-controlled ventilation (fcv) is a novel ventilation method with promising first results in porcine studies as well as clinical cross-over trials. a more efficient and maybe lung protective ventilation strategy would be crucial in the challenging situation of one lung ventilation during thoracic surgery, when the whole gas exchange has to be provided by just one half of the lungs. thus, individualized fcv, based on compliance guided pressure settings, will be compared to standard of pressure-controlled ventilation in thoracic surgery requiring one lung ventilation in a randomized controlled trial. based on previous preclinical trials an improvement of oxygenation by 15% will be expected and in order to transfer the preclinical results to humans oxygenation assessed by pao2 / fio2 ratio after 30 minutes of one lung ventilation is the main primary outcome parameter of this study. furthermore, improved recruitment of lung tissue due to controlled expiratory flow in fcv will be anticipated without the need of recruitment maneuvers, which may cause deleterious effects on lung tissue. accordingly any recruitment maneuvers will be omitted in the fcv group. the investigators hypothesize that improved gas exchange in terms of improved oxygenation and reduced respiratory minute volume required for co2-removal will be achieved with fcv compared to pcv. secondary outcome parameters such as the incidence of postoperative pulmonary complications will be additionally assessed in order to plan future studies with clinically relevant outcome.

Eligibility criteria:
inclusion criteria: * male and female subjects ≥ 18 years * body weight ≥ 40 kg * elective thoracic surgery requiring olv * asa i-iii * written informed consent exclusion criteria: * emergency surgery * female subjects known to be pregnant * known participation in another interventional clinical trial * high pulmonary risk (ppo fev1\<20ml/kg in male or ppo fev1\<18ml/kg in female) * empyema evacuation or signs of pulmonary infection * high grade cmp (ef\<30%)

Keywords: flow controlled ventilation pressure controlled ventilation thoracic surgery one lung ventilation
comparison of conservative and endovascular treatment for spontaneously isolated superior mesenteric artery dissection

Conditions: Spontaneous Isolated Superior Mesenteric Artery Dissection

Summary: spontaneous isolated superior mesenteric artery dissection(sismad) is an increasingly diagnosed disease. however, prospective, multicenter studies that can provide evidence to support clinical decisions are very limited. this study aims to compare the therapeutic efficacy of conservative and endovascular treatment for sismad.


Eligibility criteria:
inclusion criteria: 1. aged 18 and above; 2. isolated superior mesenteric artery dissection with clear symptoms or history and confirmed by cta 3. signed informed consent forms, willing to receive treatments exclusion criteria: 1. symptoms are severe and patients need exploratory laparotomy; 2. patients with aortic dissection, iliac artery dissection, or autoimmune vasculitis; 3. patients with mental illness cannot cooperate subjectively; 4. patients who are allergic to contrast agents, or contraindicated to conservative treatment drugs, and cannot be treated with drugs; 5. pregnancy and breastfeeding women, or patients who have recent birth plans; 6. patients who are participating in other clinical projects; 7. patients are not suitable to participate in this study.
imaging of neuroendocrine tumors with pet and fluoro-18-dopa (f-dopa)

Conditions: Neuroendocrine Tumors

Summary: imaging of neuroendocrine (nets), such as carcinoids and pheochromocytomas (pheos), is suboptimal, limiting curative treatment. the investigators wanted to explore the use of pet and f-dopa i.v. for the localization of these types of neoplasms. the investigators used a similar protocol as they had used for pet (positron emission tomography) or fdg (fludeoxyglucose) imaging in oncologic patients. f-dopa, prepared according to united states pharmacopeia (usp) guidelines, was approved by the north shore university hospital radiation safety committee in 1989 and 1994 for the study of neurological diseases and used uneventfully.

background: pre surgical conventional imaging of neuroendocrine tumors (nets) with ct, mri, in-111 octreotide or 1-123-mibg (metaiodobenzylguanidine) scintigraphy has limitations. this pilot study tried to improve the localization of these tumors with f-18-f-dopa pet scanning. methods: the investigators studied 22 patients, the majority referred with clinical diagnosis of carcinoid (9) or nets (9) and a few with pheochromocytoma/paraganglioma (3). carbidopa was administered prior to the f-dopa injection in 12 patients. comparison was made with prior conventional imaging. the f-dopa findings, read blindly to the findings of other modalities, were compared with results of subsequent surgery (2), endoscopy (1), or a long-term follow up of mean duration of 49 months (for 20 patients). two subjects were lost to follow-up.

Eligibility criteria:
* inclusion criteria: * 23 years of age and older * appropriate diagnosis by referring physician * exclusion criteria: * less than 23 years of age * greater than 81 years of age * pregnancy * lactation * prior history of radiation treatment * chemotherapy or anti-tuberculosis medications.
improved fertility after exercise in overweight/obese women

Conditions: Obesity; Infertility, Female

Summary: overweight/obesity is associated with sub-fertility. the investigators will assess if regular exercise training prior to assisted fertilization will improve pregnancy rate in overweight/obese women referred to assisted fertilization. it is expected that training will be successful in increasing pregnancy rate

obesity is associated with several diseases, as type 2 diabetes, cardiovascular disease and some types of cancer, this is of great concern for the public health. also, of more immediate importance for these women; obesity is associated with increased risks of sub-fertility. the overall aim of the current project is to expand the knowledge about effective interventions to prevent the increasing prevalence of obesity-associated sub-fertility in population. one cause of the increased referral rate for in-vitro fertilization is the growing prevalence of overweight and obesity. currently, about 700 couples are annually referred for in-vitro fertilization at st.olav's hospital. in this interdisciplinary trial, involving physiotherapists, exercise physiologists, gynecologists, and basic researchers, the effects of regular high intensity exercise training on fertility in sub-fertile overweight and obese women will be investigated.

Eligibility criteria:
inclusion criteria: * body mass index (weight in kg/height in cm squared) \>25 * accepted for assisted fertilization treatment at st.olav's hospital exclusion criteria: * low responders, defined as amh \<2 pmol/l or \< 5 oocytes in prior in vitro fertilisation (ivf)/intracytoplasmic sperm injection (icsi) cycles or antral follicle count (afc) \< 5 * current or previous metformin use (a wash-out period of \> four weeks)

Keywords: pregnancy fertility exercise fertilization in vitro
nifedipine for acute tocolysis of preterm labor

Conditions: Preterm Labor

Summary: the purpose of this study is to determine if nifedipine treatment of women in preterm labor receiving corticosteroids results in postponement of delivery when compared to placebo.


Eligibility criteria:
inclusion criteria: * between 16 and 44 years of age inclusive * singleton pregnancy * intact membranes * between 28-0/7 weeks and 33-6/7 weeks' gestation inclusive * reported or documented uterine activity * cervical dilation between 2 cm and 4 cm inclusive exclusion criteria: * multifetal gestation * less than 28 weeks' gestation * 34 or more weeks' gestation * ruptured membranes * more than 4 cm dilated * previously received a course of corticosteroids for fetal lung maturation * oligohydramnios * fetal growth restriction * chorioamnionitis or temperature of at least 38.0 degrees celsius * fetal death * preeclampsia * suspected placental abruption or placenta previa * lethal fetal malformation or amniotic fluid index at least 35 * systolic bp \< 90 mmhg or diastolic bp \< 50 mmhg * baseline tachycardia (pulse \>120 after 2 consecutive measurements 30 minutes apart) * chronic hypertension treated with antihypertensives in pregnancy * seizure disorder or hiv * maternal allergy to nifedipine * known maternal cardiac disease * women who have received progesterone therapy in the second or third trimester for prevention of preterm birth
frespaciguat (mk-5475) in participants with hypoxemia due to covid-19 pneumonia (mk-5475-009)

Conditions: Coronavirus Disease 2019 (COVID-19); Pneumonia; Hypoxemia

Summary: the purpose of this study is to evaluate safety, tolerability, and pharmacodynamics of frespaciguat after administration of multiple doses to participants with covid-19 pneumonia. the primary hypothesis is that frespaciguat when administered to participants with covid-19 pneumonia and hypoxemia improves arterial oxygenation as measured by the ratio of blood oxygen saturation to fraction of inspired oxygen (spo2/fio2 ratio) compared to placebo.


Eligibility criteria:
inclusion criteria: * has virologically confirmed covid-19 requiring hospital admission. * has respiratory symptoms including cough and dyspnea * requires supplemental oxygen therapy * male participant is abstinent from heterosexual intercourse or agrees to use contraception during the intervention period and for at least 14 days, corresponding to time needed to eliminate study intervention(s) (example, 5 terminal half-lives after the last dose of study intervention) * female participant is not a woman of childbearing potential (wocbp) or is a wocbp who is abstinent from heterosexual intercourse or using contraception during the intervention period and for at least 14 days, corresponding to time needed to eliminate study intervention(s) (example, 5 terminal half-lives after the last dose of study intervention) exclusion criteria: * has pre-existing medical conditions of any nature which are immediately pre-terminal such as death or limitation of life-sustaining therapy is expected to be imminent * requires or is expected to require invasive mechanical ventilation * requires or is expected to require noninvasive mechanical ventilation * has any issue which would prohibit them from effective use of the frespaciguat inhaler * hypoxemia which is explained by any condition other than covid-19, example, preexisting cardiac or pulmonary disease * has severe hepatic impairment (meets child-pugh class c criteria) * has severe renal impairment and/or requirement for renal dialysis
an observational study for dacogen long-term treatment in patients with myelodysplastic syndrome

Conditions: Myelodysplastic Syndromes

Summary: the purpose of this study is to investigate the overall response rate (orr) and safety when treating patients with myelodysplastic syndrome with decitabine. decitabine is to be administered as long as there is evidence of clinical benefit.

this study is a prospective (the study follows a group of individuals over time), open label (all people involved know the identity of the intervention), multicenter, single arm (one group of patients receiving the same treatment), observational study to observe the response rate and safety of decitabine when treating patients with myelodysplastic syndrome with decitabine. decitabine is to be administered as long as there is evidence of clinical benefit. it will be assessed if the treatment duration could be prolonged by appropriate toxicity management such as an active antibiotic prophylaxis or dose and schedule modification, and whether this leads to potentially increased clinical benefits such as higher response rate, longer time to acute myeloid leukemia, and prolonged overall survival. for safety evaluation, adverse events and peripheral blood findings will be collected. the patient will receive decitabine intravenous injection 20mg/m2 once a day for 5 consecutive days every 4 weeks.

Eligibility criteria:
inclusion criteria: * patients diagnosed with (primary or secondary) myelodysplastic syndrome including chronic myelomonocytic leukemia (cmml) * patients with an international prognostic scoring system \>= int-1 * patients who were never treated with hypomethylating agent (azacitidine and decitabine) * female patients who are postmenopausal or received contraceptive operation or refrain from sexual relations. women of childbearing potential should conduct an effective method of birth control (oral contraceptives, injections, intrauterine device, double barrier method, contraceptive patch and male partner's sterilization), in case of male patients who will not have a baby within 2 months after the completion of decitabine therapy * patients who signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. exclusion criteria: * patients diagnosed with acute myelogenous leukemia (aml, bone marrow stem cell counts exceeding 20%) or other progressive malignant diseases * patients with active infection of virus or bacteria * patients who used to be treated with azacitidine or decitabine * patients who are hypersensitive to excipients of decitabine * patients who are pregnant or breast-feeding.

Keywords: myelodysplastic syndrome dacogen decitabine epigenetic therapy hypomethylating agent
the effect of short-term insulin intensive therapy based on the application of insulin pump and real-time dynamic glucose monitoring technology on reversing the newly diagnosed type 2 diabetes

Conditions: Insulin Pump，Continuous Glucose Monitoring Technology

Summary: this study aims to explore the effectiveness and safety of the in-hospital-out-of-hospital synergistic short-term insulin intensive therapy model based on patch insulin pump and continuous glucose monitoring technology through a randomized controlled study, and evaluate the possibility of blood glucose parameters derived from continuous glucose technology in predicting long-term blood glucose remission, so as to provide important reference data for the precision, intelligence, and integrated improvement of short-term insulin intensive therapy.


Eligibility criteria:
inclusion criteria:1: have never received any hypoglycemic treatment (including oral hypoglycemic drugs, traditional chinese medicine hypoglycemic drugs, insulin) type 2 diabetes patients, or type 2 diabetes patients with diagnosis time less than 1 year, use hypoglycemic drugs no more than 1 type, with a usage time of no more than 1 week, and discontinuation of medication for more than 1 week when selected 2: a1c of glycosylated hemoglobin ≥ 8.0%, and abdominal blood glucose\>7.0mmol/l during enrollment 3: age range from 18 to 70 years old, with a body mass index (bmi) of 20-35kg/m2 4: agrees to use contraception during the study process 5: able and willing to use a dynamic blood glucose system and monitor blood glucose according to project requirements, and accept out of hospital lifestyle management and insulin hypoglycemic management. - exclusion criteria:1: not type 2 diabetes 2: the medication used is allergic or intolerable 3: acute complications of diabetes 4: severe microvascular complications 5: severe macrovascular complications 6: blood pressure consistently exceeds 180/110mmhg and cannot be controlled within 160/110mmhg within 1 week 7: the clearance rate of blood creatinine is less than 45ml/min/1.73m2, the alt is ≥ 3 times the normal upper limit, and the total bilirubin is ≥ 2 times the normal upper limit and lasts for more than 1 week 8: hemoglobin\<100g/l or requires regular blood transfusion treatment 9: accumulated time of using drugs that may affect blood sugar within 12 weeks for more than 1 week 10: systemic infection or severe accompanying diseases 11: patients with malignant tumors or chronic diarrhea 12: uncontrolled endocrine gland dysfunction 13: mental disorders 14: chronic heart failure, with a heart function grading of iii or above 15: pregnant, breastfeeding, women of childbearing age who are unwilling to use contraception during the study period, or have surgery plans that require general anesthesia in the near future (within 6 months) 16: the subject is uncooperative, unable to follow up, or the researcher determines that it may be difficult to complete the study. 17: other situations that the researcher determines are not suitable for inclusion -
lisa post market clinical follow-up study: documentation of clinical outcomes after surgery with lisa implant

Conditions: Chronic Low-back Pain; Herniated Disc; Degenerative Disc Disease; Lumbar Canal Stenosis

Summary: the study is a post-market surveillance study of the lumbar implant for stiffness augmentation (lisa), a medical device, which is used to treat low-back pain that accompanies degenerative lesions of grades ii, iii, and iv (pfirrmann mri classification). "post-market" means the device (i.e. the lisa implant) being used in this study has already obtained ce certification and is commercially available for use in the european market. the lisa device consists of 3 components: a peek interspinous spacer, a polyester band, and a titanium blocker. the spacer is positioned between two adjacent spinous processes, the band is belted around the spinous processes and through the spacer, and the blocker is used to lock the band inside the spacer. medical device manufacturers conduct "post-market" clinical studies in order to continuously evaluate the product scientifically and to comply with legal and ethical obligations. with these studies, the long-term safety as well as performance of their medical devices are assessed. this study, which is initiated and sponsored by backbone (lisa designer, developer, manufacturer and marketer), aims to evaluate the long-term safety and performance of the lisa implant for the treatment of lumbar degenerative disease and to evaluate the treatment.


Eligibility criteria:
inclusion criteria: * skeletally mature patients patient ≥18 years of age * patients with low-back pain caused by degenerative lesions of grade ii, iii and iv (pfirrmann mri classification) * failed conservative treatment for low back pain conducted for at least 6 months exclusion criteria: * stage v degenerative disk lesions in pfirrmann's mri classification * spondylolisthesis * osteoporosis * non-specific back pain * modic 2 and modic 3 changes * l5/s1 segments affected * local or general infections that may compromise the surgical goals * major local inflammatory phenomena * pregnant and lactating women * immunosuppressive diseases * bone immaturity * severe mental illnesses * bone metabolism diseases that may compromise the mechanical support expected from this type of implant * patient with worker's compensation, under litigation or on disability benefits * excessive physical activities * patients deprived of their liberty in accordance with respective national regulations * protected patients or patients not in a position to declare his or her consent in accordance with respective national regulations

Keywords: chronic low-back pain herniated disc degenerative disc disease lumbar canal stenosis dynamic stabilization implants post-market clinical follow-up study
"ok 2004 study" (only kaletra 2004 study): study to evaluate suspending nucleosides from triple-drug therapy in hiv subjects

Conditions: HIV Infection

Summary: lopinavir/ritonavir monotherapy may maintain virologic suppression in patients who have been undetectable for six months while on triple drug antiretroviral therapy. lopinavir/ritonavir pharmacokinetics might prevent resistance development in patients who experience virological rebound after single-drug simplification.

primary study objective: efficacy and durability of switching to lopinavir/ritonavir single-drug haart compared to maintaining therapy based on lopinavir/ritonavir and two nucleosides secondary study objective(s): * safety (related drug aes/saes and laboratory anomalies g3/4) through 48 w. * resistance profile on patients with sustained virological failure * qol comparing stopping nucleosides versus continuing therapy * pharmaco-economic analysis comparing treatment cost between the 2 study arms. * predicting factors of failure in the stopping nucleosides arm subject population: 200 patients study design: randomization: patients are randomized (1:1) either to continue under the same treatment or stop nucleosides as follows: * stopping nucleosides arm: lopinavir/r alone. * continuing arm: lopinavir/r + 2 nrtis study procedures: a baseline hiv-rna, cd4 and routine labs will be collected if the most recent results are not collected within the 4 weeks prior entering the study. patients will be followed for hiv-rna (and cd4) at w1, w4, w8, w16, w24, w 36 and w48. after w48, durability of response to lopinavir/r single-drug therapy will be studied long-term (up to w96). routine hematology and clinical chemistry (including fasting triglycerides and cholesterol, total and hdl/ldl ratio) will be measured at w4, w16, w24, w 36 and w48. a central laboratory will be used for hiv-rna determinations and to archive plasma/cell samples for further genotype test in case of rebound. treatment adherence will be followed with a self-patient report questionnaire (geema study) all aes will be collected if suspected relation (possible or probable) to any concomitant arv drug, and saes, related or not, reported within 24h.

Eligibility criteria:
inclusion criteria: * hiv patients \> 18 years old who provide signed and dated informed consent. * hiv patients who have been receiving lopinavir/ritonavir and two nucleosides during at least 4 weeks. * plasma hiv rna \< 50 cop/ml for six months exclusion criteria: * hiv patients who have stopped a protease inhibitor due to virological failure. * hiv patients with hepatic or renal insufficiency. * hiv patients with positive serum hbvag * hiv patients who require treatment with a lopinavir/r contraindicated medication. * hiv pregnant or breastfeeding women. * active drug abuse (including alcohol or recreational drugs). exception, cannabis, provided the investigator is confident in patient adherence. patients under methadone program will be accepted too if deemed appropriate by the investigator.

Keywords: hiv aids treatment experienced