Kornimate/medical-research-clean huggingface dataset:
sort - af supervised obesity reduction trial for af ablation patients

Conditions: Atrial Fibrillation; Obesity; Sleep Apnea

Summary: study hypothesis: weight reduction in obese patients with atrial fibrillation. obese patients benefit from an obesity treatment after atrial fibrillation ablation. study design: a prospective randomized, open-label clinical trial.

study protocol: the purpose of this study is to proof a professional care of overweight patients with symptomatic atrial fibrillation, as well as the treatment of the risk factors for atrial fibrillation, especially obstructive sleep apnea and hypertension. there is a 1:1 randomization. in the intervention group, patients are followed up in a 6-month intensive care after atrial fibrillation ablation. during the follow up time patients will visit the nutritional advice every two weeks for 6 months. the follow-up in the control group is standard of care. at baseline, a screening test for obstructive sleep apnea and arterial hypertension will be performed as standard care. the documentation of atrial fibrillation after ablation is made possible by the implantation of an event recorder before atrial fibrillation ablation. follow up: a follow-up will be performed after 3,6 and 12 months in both groups. patients in the intervention group will be followed-up every 2 weeks in the first 6 months.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * overweight with a bmi ≥ 30 * obtained written informed consent * symptomatic atrial fibrillation with indication for ablation exclusion criteria: * age \<18 years * permanent atrial fibrillation (failed cardioversion or episode duration \> 12 months) * previous surgical or interventional therapy of atrial fibrillation * bmi \> 40 * pregnant women or women of childbearing potential without a negative pregnancy test within 48 hours prior to treatment * history of hemorrhagic diathesis or other coagulopathies * contraindications for oral anticoagulation * hyper- or hypothyroidism * drug or chronic alcohol abuse * has any condition that would make participation not be in the best interest of the subject * incompliance * unable to perform athletic exercise due to disease or disability * resident outside hamburg

Keywords: bmi >40
effect of myomectomy for intramural myoma on fertility outcomes in infertile women

Conditions: Infertility; Fibroid

Summary: the aim of this study is to evaluate the effect of myomectomy for intramural myomas on the fertility outcomes in infertile women.

all women participating in the study will be randomly allocated into two groups; myomectomy group and conservative management group. women in the myomectomy group will be subjected to laparotomy to remove the myomas while women in the conservative management group will not be subjected to surgery. women in the myomectomy group will be asked to abstain from having sexual intercourse (or use a barrier contraception method) for 3 months after surgery then to start having regular fertility-oriented intercourse after that. women in the conservative management group will be asked to immediately start having regular fertility-oriented intercourse. women in both groups will be monitored form the time of starting regular intercourse and for one year for occurrence of clinical pregnancy.

Eligibility criteria:
inclusion criteria: * infertility for at least one year. * presence of intramural myoma. * absence of any other cause of infertility as revealed by basic infertility work up including laparoscopy. exclusion criteria: * age is \ 33 years. * symptomatic fibroid causing pelviabdominal swelling. * presence of \> 2 myomas. * presence of a coexisting another type of myoma other than intramural myoma (e.g. submucosal, subserosal, cervical or ligamentary myoma). * presence of any other cause of infertility.
effects of sugar sweetened beverage on metabolic health in male and female adolescents

Conditions: Insulin Sensitivity; Insulin Tolerance

Summary: we examined the effects of short-term (2-wk) consumption of hf- and hg-sweetened beverages in adolescents (15-20 yr of age) on insulin sensitivity, insulin secretion, insulin clearance, triacylglycerol (tag), and cholesterol concentrations.

this counterbalanced study consisted of two trials including 1) high fructose (hf) trial and, 2) a high glucose (hg) trial. each trial was blind to the participant, performed in a random order, and was 15 d in length. during days 1-14 of each trial, the participants consumed either 710 ml per day of a hf-sweetened beverage (sweetened with 50 g fructose and 15 g glucose) for 2-wk (hf trial) or 710 ml per day of a hg-sweetened beverage (sweetened with 50 g glucose and 15 g fructose) for 2-wk (hg trial) on top of their normal diet. in addition, the participants were instructed to maintain their normal physical activity levels during each trial (which were measured with an accelerometer). on day 15 of each trial, the participants reported to the lab after a \~ 11 h overnight fast for metabolic testing. during this testing day, the participants remained in the lab for 12 h and consumed three liquid meals (one meal every 4 h and hf meals during hf trial and hg meals during hg trial), while blood samples were taken every 15 or 30 min throughout the 12 h testing day. during testing, the participants remained physically inactive (\< 3,000 steps).

Eligibility criteria:
inclusion criteria: males and females 15-20 years of age not participating in an organized sport (non-athletes) no history of heart, lung, kidney, endocrine, or gastrointestinal disease no medications known to alter glucose or lipid metabolism normal fasting blood glucose concentrations (\< 100 mg/dl) normal fasting triglyceride concentrations (\< 150 mg/dl) average daily fructose consumption \< 90th percentile for age and sex exclusion criteria: athlete type 1 diabetic type 2 diabetic consuming high quantities of fructose

Keywords: sugar sweetened beverages metabolism endocrine lipids blood glucose
study of patient navigation to promote colon cancer screening

Conditions: Colorectal Cancer Screening

Summary: this study will investigate whether patient navigation can increase rates of colorectal cancer screening among linguistically and culturally diverse disadvantaged patients served by urban community health centers.


Eligibility criteria:
inclusion criteria: * patients aged 52-75 who had one visit to a primary care physician in a community health center in each of the 2 previous years and who have not received colorectal cancer screening based on hedis criteria. exclusion criteria: * current cancer diagnosis, undergoing treatment (or treatment completed within the past year) * severe cardiac disease (high-risk cad,9 valvular disease, nyha class iii or iv chf, ef \< 35%) * severe copd (fev1\< 1liter or on home oxygen) * cva with severe functional impairment (aphasia or hemiparesis) * ms with severe functional impairment * renal failure with crcl\< 30 or on dialysis * gastrointestinal symptoms (pain, bleeding, etc) within the past 6 months * chronic active liver disease or cirrhosis, with albumin \< 3 or elevated inr * advanced hiv disease (cd4 count \<200) * severe lupus (with cerebritis or renal failure as defined above) * severe complications of diabetes (blindness, amputations other than toes) * advanced dementia * psychosis * paranoia * active substance abuse * schizophrenia * psychiatric hospitalization within the past year

Keywords: community health centers colorectal cancer screening urban health
study to evaluate of exg34217 in patients with telomere biology disorders with bone marrow failure

Conditions: Telomere Shortening; Bone Marrow Failure

Summary: this is a phase i/ii, open label, single center study to assess the safety and tolerability of exg34217 in bone marrow failure patients with telomere biology disorders.

this is a phase i/ii, open label study in up to 12 subjects with telomere biology disorders with bone marrow failure. the study is open to all participants regardless of gender or ethnicity. subjects who are enrolled but not evaluable will be replaced. subjects will sign a consent form prior to any study related procedure and will complete baseline screening assessments. subjects for this study will not require any preparative regimen such as chemotherapy or radiation. the study will be conducted in three parts * peripheral blood mononuclear cells (pbmncs) collection; mobilization and apheresis, * ex vivo cell processing * processed cell infusion and post-infusion safety monitoring, * follow-up (week 2, 3,4,5, months 1, 2,3,4,5,6,9 and 12)

Eligibility criteria:
inclusion criteria: * age 12 years and above * mild or moderate bone marrow failure defined by satisfying specific conditions. * diagnosis of telomere biology disorders exclusion criteria: * women of child bearing potential or breastfeeding. * patients with cancer who are on active chemotherapeutic treatment. * patients with severe bone marrow failure. * clonal cytogenetic abnormalities associated with mds or aml on bone marrow examination. * uncontrolled bacterial, viral or fungal infections. * prior allogeneic marrow or stem cell transplantation. * patients who are not eligible for g-csf and plerixafor dosing. * patients who are not eligible for the apheresis. * patients currently taking or have taken danazol and androgens within 60 days prior to day 1. * patients with any other clinically relevant acute or chronic diseases which could interfere with the patients' safety during the trial, expose them to undue risk, or which could interfere with study objectives. * patients who have participated in another clinical trial with an investigational drug within the previous 30 days.
an open-label, single arm study of the efficacy of accelerated intermittent theta burst stimulation in schizophrenia patients with persistent negative symptoms

Conditions: Schizophrenia; Negative Type

Summary: schizophrenia patients commonly present with persistent negative symptoms which remain the main reason for dysfunction after recovery from an acute episode of psychotic symptoms. negative symptoms in schizophrenia exact significant burden with no effective pharmacological or behavior treatment options thus far. neuromodulatory modalities present a novel and alternative treatment approach and recent trials have shown preliminary evidence for the efficacy of intermittent theta burst stimulation (itbs) to treat negative symptoms in schizophrenia. in this study, we aim to examine the effectiveness of an accelerated itbs treatment protocol as an augmentation treatment regime for patient in rehabilitation care with persistent negative symptoms. we propose a pragmatic, open label and single arm clinical trial. forty patients with diagnosis of schizophrenia, who had been stabilized from psychotic symptoms and currently suffering from dominant negative symptoms will be recruited and undergo accelerated itbs treatment for 5 consecutive sessions each day for 5 working days. participants will be followed up immediately, 1 month and 3 months after the end of treatment. clinical assessment includes, bnss, the brief negative symptom scale; sans, scale for the assessment of negative symptoms; saps, scale for the assessment of positive symptoms; panss, positive and negative symptoms scale; moca, montreal cognitive assessment scale; cdss, calgary depression scale for schizophrenia: sds, sheehans' disability scale and eq-5d. the primary endpoint of the trial is the change of negative symptoms as assessed by panss, negative symptoms subscale immediately after the treatment. this study will determine whether accelerated itbs is effective to be delivered as an augmentation therapy for patients with persistent negative symptoms. the optimal treatment system for this population can be immediately translated to clinical practice and benefit patients in need.


Eligibility criteria:
inclusion criteria: 1. age ≥21 and ≤65 years; 2. with primary diagnosis of schizophrenia or schizoaffective disorder; 3. patients experienced prominent and persistent negative symptoms \[scale for the assessment of negative symptoms (sans) score ≥3 or positive and negative symptoms scale (panss)- negative subscale score ≥20\] in past 6 months; 4. no clinically significant positive symptoms \[panss positive subscale score \<20\]; 5. no clinically significant depressive symptoms \[calgary depression scale for schizophrenia (cdss) score subscale \<12\]; 6. able to give consent. exclusion criteria: 1. with current misuse of or dependence on illegal drugs or alcohol; 2. high suicide risk; 3. history of epileptic seizures; 4. with severe brain trauma, injury or other neurological diseases; 5. metal (implants) in the skull; 6. pregnancy
phase i clinical study of sph4336 tablets in the treatment of advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this clinical study evaluated the safety and efficacy of sph4336 in the treatment of advanced solid tumors.


Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed advanced solid tumors； 2. ecog (eastern cooperative oncology group) performance status score of 0 or 1； 3. life expectancy ≥ 3 months； 4. good organ function； 5. according to the investigator's judgment, the patient could comply with the trial protocol; 6. patients who voluntarily participate in this study, completely understand this study, and voluntarily sign the informed consent form (icf). exclusion criteria: 1. received other antineoplastic therapy before the first dose； 2. had a major surgery before the first dose of study medication or was planned to have a major surgery after starting the study medication; 3. enroll in other clinical trials and receive treatment as a subject before initial medication; 4. patients with allergic constitution or history of severe allergy; 5. hepatitis b surface antigen \[hbsag\] positive and hbv-dna copy number ≥500 copies /ml or 100 iu/ml, hcv-ab positive and hcv-rna higher than the detection limit of the research center; a history of immunodeficiency; 6. cardiac criteria: presence of factors that may cause qtc prolongation or arrhythmia such as congestive heart failure, hypokalemia, congenital long qt syndrome, family history of long qt syndrome, and other concomitant medications known to prolong the qt interval. the presence of any unstable cardiovascular disease; 7. hypertension that cannot be effectively controlled after treatment; 8. have severe lung disease; 9. pregnant and lactating women; 10. female patients of reproductive age and male patients with a partner of reproductive age who were unwilling to use effective contraception throughout the trial; 11. concomitant diseases that seriously endanger patient safety or affect the completion of the study according to the investigator's judgment; 12. had a definite history of neurological or mental disorders; 13. other circumstances considered by the investigator to be inappropriate for participation in the study.
the effects of sacubitril/valsartan on the heart functions

Conditions: Drug Effect

Summary: background: sacubitril/valsartan, has been found to be more beneficial than enalapril for reducing the incidences of sudden cardiac death, death from worsening heart failure (hf), and hospitalization. however, there is no prospective echocardiographic data describing the effects of sacubitril/valsartan on the heart functions and left ventricular (lv) reverse remodeling. therefore, the aim of our study was to evaluate the effects of sacubitril/valsartan on the lv functions using two dimensional (2d), three dimensional (3d) echocardiography and the 3d strain parameters. methods: in 100 patients with hf with reduced ejection fraction (hrref) who have indications for the use of sacubitril/valsartan as recommended by recent guidelines were prospectively enrolled. the basal 2d and 3d echocardiographic parameters were compared to those obtained 3 months after starting the sacubitril/valsartan treatment.


Eligibility criteria:
inclusion criteria: * age is more than or equal 18 years old * able to provide written informed consent * indicated for the use of sacubitril/valsartan as recommended by the european society of cardiology (esc) heart failure guidelines 2016 * left ventricular ejection fraction of 40% or less exclusion criteria: * cardiac resynchronization therapy (crt) device implantation less than 3 months prior to the start of this study or crt implantation intentions * atrial fibrillation * poor echocardiographic images * sacubitril/valsartan treatment intolerance during the follow-up period

Keywords: sacubitril/valsartan heart failure ejection fraction
natural killer(nk) cell therapy in r/r aml

Conditions: AML, Adult

Summary: this is an open-label, phase i study of qn-030a (allogeneic nk cell therapy) in relapse/refractory acute myeloid leukemia (aml). this clinical study is to evaluate the safety, tolerability and preliminary efficacy of qn-030a in patients with r/r aml, where a "3+3" enrollment schema will be utilized at dose escalation stage. up to 18 patients will be enrolled.


Eligibility criteria:
key inclusion criteria: * provision of signed and dated informed consent form (icf) * ≥18 years old * diagnosis of r/r aml * eastern cooperative oncology group (ecog) performance status ≤1 * adequate organ function as defined in the protocol * donor specific antibody (dsa) to qn-030a: mfi \<= 2000 key exclusion criteria: * allergic to drug used in this study * accept other anti-tumor drugs/therapies within certain time of day 0 (first qn-030a dose infusion), time window and drug defined in the protocol. * received systemic immunosuppressive therapy within 7 days of day 0, or likely to require systemic immunosuppressive therapy * acute promyelocytic leukemia (apl) * central nervous system leukemia. * uncontrolled, active clinically significant infection * clinically significant cardiovascular disease as defined in the protocol * known hiv infection, active hepatitis b (hbv) or hepatitis c (hcv) infection * history of central nervous system (cns) disease such as stroke, epilepsy. * females are pregnant or lactating * investigator-assessed presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to subject
a multi-center study of the cf quantum® sweat test system

Conditions: Cystic Fibrosis

Summary: this is an observational comparative study to compare the standard-of-care methods for sweat testing used to support diagnosing cystic fibrosis (cf) against a new method of sweat testing called the cf quantum sweat test system. the results of the new device in this study are for comparison only and will not be used to diagnose, treat or mitigate the subject's condition.

the primary objective is to evaluate the diagnostic accuracy of a new sweat test method in both normal individuals and individuals with cf or cystic fibrosis related metabolic syndrome (crms). subject participation is for one day and duration of study for each subject is one day. no follow-up will be required. number of subjects; 300 split evenly between subjects with previously diagnosed cf or crms (cystic fibrosis related metabolic syndrome) and subjects referred to the sweat test lab for clinical reasons. number of sites = 6, u of wi-madison, u of wi-milwaukee, u of mi-ann arbor, dayton children's hospital (oh), u of mn, and children's of alabama. primary endpoints: * clinical and analytical sensitivity of the new test method * clinical and analytical sensitivity of the standard-of-care methods statistics sensitivity and specificity will be calculated and reported along with the corresponding 95% confidence intervals. bias assessment will be conducted according to the clinical and laboratory standards institute (clsi) guidelines for method comparison and bias estimation. pearson's correlation analysis will be conducted to test for adequate range of the replicate values for the new test method.

Eligibility criteria:
inclusion criteria: 1. patients referred to the sweat test lab on a clinical basis. 2. infants who require a sweat test as follow-up to an abnormal cf screening test. 3. patients who have already been diagnosed with cf or crms. 4. written informed consent (and assent when applicable) obtained from subject or subject's legal representative. exclusion criteria: 1. patient is receiving oxygen by open delivery. 2. infants less than 48 hours of age. 3. diffuse inflammation or rash on the collection site. 4. patients who have had a reaction to a prior iontophoretic sweat test procedure. 5. arm is too small for both the new and conventional sweat test.
efficacy and safety outcomes of optometrist performed selective laser trabeculoplasty (slt)

Conditions: Primary Open-Angle Glaucoma, Unspecified Eye; Ocular Hypertension

Summary: to measure the efficacy and safety outcomes of slt performed by optometrists.

participants will undergo a pre-procedure examination in order to record baseline findings and to determine if they meet the inclusion criteria in order to undergo the procedure. participants will undergo the slt procedure and will be examined at 1 hour, 1 week and 6 weeks. follow up examinations will evaluate eye pressure reduction and post-procedure complications. the rate complication post-procedure are typically low.

Eligibility criteria:
inclusion criteria: 1. ability to provide written informed consent; 2. at least 18 years of age, male or female, of native american or alaskan native descent; 3. diagnosed with primary open angle glaucoma or ocular hypertension; 4. documented intraocular pressure greater than or equal to 23 mmhg; 5. no prior glaucoma treatment unless treated with one topical drop. exclusion criteria: 1. history of trauma or ocular surgery within the last 6 months; 2. history of corneal dystrophy; 3. current use of topical or systemic steroids; 4. advanced or severe glaucomatous findings based on comprehensive examination; 5. diagnosed with other types of glaucoma such as pseudoexfoliation syndrome, pigmentary glaucoma, normal tension glaucoma, and other additional glaucoma subtypes.
registry for chronic venous disease incidence and natural course

Conditions: Varicose Veins of Lower Limb

Summary: a prospective cohort study of patients with primary varicose veins to assess the morbidity, risk factors and development of chronic lower limb vein disease.

multicenter prospective cohort observational study based on a termless epidemiological registry. periodic inspection and collection of data from the subjects is carried out annually, in the last quarter of the current year. patient data is recorded in a promising digital database and is constantly updated.

Eligibility criteria:
inclusion criteria: * a family members of the researcher (spouse, childrens, brothers and sisters, parents) or the researcher himself * the possibility of annual clinical and ultrasound assessment of the venous system of the observed individuals exclusion criteria: * any invasive treatment of the chronic venous disorder in anamnesis * venous thrombosis in the anamnesis or at the time of inclusion