Kornimate/medical-research-clean huggingface dataset:
outcome predictors of trachea-esophageal fistula

Conditions: Tracheo Esophageal Fistula

Summary: in the present study, the investigator aim to evaluate the prevalence, factors affecting outcome and the outcome of neonates with tracheoesophageal fistula.

tracheoesophageal fistula is a connection between the esophagus and the trachea. tracheoesophageal fistula (tef) represents one of the most common congenital anomalies seen in infants, infants with tef classically present with respiratory distress, feeding difficulties, choking, and risk for aspiration. tef is most commonly associated with other congenital anomalies, particularly cardiac defects. esophageal atresia (ea) is a related congenital malformation with a similar presentation to tef and can occur with or without the presence of a fistula. although the events leading to separation of the primitive trachea and esophagus are not completely understood, the most commonly accepted hypothesis is that a defect in the lateral septation of the foregut into the trachea and esophagus causes tef and ea. the trachea and esophagus develop from a common primitive foregut, and at approximately 4 weeks of gestation, the developing respiratory and gastrointestinal tracts are separated by epithelial ridges. the foregut divides into a ventral respiratory tract and a dorsal esophageal tract; the fistula tract is thought to derive from an embryonic lung bud that fails to undergo branching. these defects of mesenchymal proliferation are thought to lead to tef formation. the incidence of tef is approximately 1 in 3500 births. ea and tef are classified according to their anatomic configuration.

Eligibility criteria:
inclusion criteria: * patients diagnosed with tracheoesophageal fistula are/below the age of 28 days. exclusion criteria: * patients above the age of 28 days. * patients diagnosed with other diseases. * patients with acquired tracheoesophageal fistula.
registry for patients with wilms' tumor suppressor gene 1 (wt1) mutation associated diseases

Conditions: Denys-Drash Syndrome; Frasier Syndrome; Nephrotic Syndrome; Wilms Tumor

Summary: the wilms' tumor suppressor gene 1 (wt1) encodes for a transcription factor which plays an important role during urogenital development. patients carrying a wt1 germline mutation show symptoms like proteinuria, wilms tumors, genital malformations and kidney failure. milder variants are possible and classification is not always possible. in this registry we are collecting detailed clinical data of affected individuals to establish genotype-phenotype correlations with the greater goal to optimize patient care.

the wilms' tumor suppressor gene 1 (wt1) encodes for a transcription factor which plays an important role during urogenital development. patients carrying a wt1 germline mutation show symptoms like proteinuria, wilms tumors, genital malformations and kidney failure, which usually occur in early childhood. milder variants are possible and classification as one of the three rare syndromes associated with wt1 mutations (denys-drash syndrome, frasier syndrome or wagr syndrome) is not always possible. in this registry we are collecting detailed clinical data of affected individuals to establish genotype-phenotype correlations with the greater goal to optimize patient care.

Eligibility criteria:
inclusion criteria: * germline mutation in wt1 gene exclusion criteria: * none

Keywords: wt1 wilms tumor denys-drash syndrome nephrotic syndrome proteinuria
the pain pen for breakthrough cancer pain

Conditions: Neoplasms; Pain

Summary: the purpose of this study is to see whether injection of hydromorphone through a subcutaneous injection device is more effective in treating breakthrough cancer pain than oral morphine.

breakthrough pain is an exacerbation of severe pain that occurs on a background of otherwise controlled pain. breakthrough pain is common in patients with advanced cancer. current medications to treat breakthrough pain include oral immediate release opioid formulations and more recently oral transmucosal fentanyl citrate. the pain pen study is a randomized controlled double blind cross-over study comparing the efficacy of oral immediate release morphine with that of subcutaneous hydromorphone, injected through a so called pain pen, on breakthrough pain in cancer patients. preliminary experience with the pain pen suggests that it has a more rapid time of onset of pain relief than oral formulations.

Eligibility criteria:
inclusion criteria: * stable cancer pain requiring the equivalent of 60-1000 mg oral morphine/day * 1-4 breakthrough pain episodes/day * patients must be able, in the opinion of the investigator, to fully comply with trial requirements * patients who have given written informed consent exclusion criteria: * uncontrolled pain * women who are pregnant, lactating or intend to become pregnant * cardiopulmonary disease that would increase the risk of opioids * neurologic or psychiatric disease that would compromise data collection * recently started chemotherapy or radiotherapy in as far as it would be effective in lowering breakthrough pain
the effect of probiotics on functional constipation in the elderly

Conditions: Functional Constipation

Summary: the main scope of the proposed research in the framework is to investigate the effect of probiotic bacteria lactobacillus acidophilus la3, bifidobacterium animalis ssp. lactis blc1 i lactobacillus casei bgp93 on functional constipation and on the quality of life of the elderly in a nursing home. the experimental part will consists of double-blind, placebo-controlled clinical trial over 12 weeks.

during the first four weeks, the subjects were monitored primarily concerning bowel discharges and general health. after that initial four weeks, they are re-evaluated compliance with inclusion and exclusion criteria. participants were allocated to the double-blind section of the trial (12 weeks), using o computer-generated to a placebo group or in the probiotic group in the form of a liquid oral formulation once a day. on first day of intervention participants provide a blood sample. all investigators, participants and study personnel were blinded to the order of randomization. participants were told to consume 9 drops of study probiotics once a day for next 12-week intervention. on last day of intervention, participants provide a blood sample. the last four weeks of the double-blind section (week 9-12) participants an evaluation period in which the respondents were evaluated for the outcomes of the study. after completing the double-blind study, the participants were followed for an additional four weeks. inclusive / excluded criteria are evaluated on two occasions, at the time of inclusion in the 4-week introductory section and its end.

Eligibility criteria:
inclusion criteria: * age 65 years or more * signed informed consent for study participation * functional constipation defined by rome iv criteria * ability to understand the procedure exclusion criteria: * suspicion of obstructive ileus or previous obstructive ileus * suspected or confirmed diagnosis: irritable colon syndrome, ulcerative colitis, crohn's disease, malignant digestive tract disease * diarrhoea of any cause within the last month * acute infectious disease within the last month excluding people who use antibiotics * persons who have opioid analgesics in pharmacotherapy

Keywords: constipation elderly probiotics
renal effects of three iodinated contrast media (cm) in patients at risk undergoing coronary angiography

Conditions: Coronary Artery Disease (CAD); Renal Impairment; Diabetes Mellitus

Summary: the study is to evaluate and compare the effects on kidney function of three iodinated contrast media (cm) in patients at risk of kidney damage evaluating serum creatinine (scr) concentrations up to three days after cm administration.


Eligibility criteria:
inclusion criteria: * subjects with a combination of dm (type i or ii) and renal impairment (ri), defined as scr ≥150 µmol/l (1.7 mg/dl) for men and ≥133 µmol/l (1.5 mg/dl) for women or creatinine clearance (crcl) ≤50 ml/min calculated according to cockroft-gault formula, referred for coronary angiography with or without pci. exclusion criteria: * concurrent administration of potentially nephroprotective or nephrotoxic drugs is not allowed. subjects undergoing dialysis or kidney transplantation or with crcl \< 20 ml/min will not be included.

Keywords: coronary artery disease (cad), renal impairment, serum creatinine (scr), iodixanol, ioversol, iopromide, contrast induced nephropathy (cin)
brief hiv prevention counseling for sti patients in south africa

Conditions: Sexually Transmitted Infections

Summary: this is a randomized trial to test a brief single session risk reduction counseling intervention on hiv and sti behavioral outcomes in cape town south africa.

this 5 year study will conduct a randomized clinical trial of a gender and culturally tailored theory-based behavioral risk reduction intervention for men and women who are receiving sexually transmitted infection (sti) diagnostic and treatment services from sti treatment providers in south africa. as many as one in five south africans is hiv positive and there are an estimated 1,500 new hiv infections in south africa each day. the experimental intervention in this study was developed by south african and us investigators and pilot tested in south africa. the intervention is grounded in the experience of south african health service provider, empirical research on aids-related stigmas, and elements of a social cognitive theory of health behavior change. the intervention consists of a single 60-minute risk reduction counseling session delivered within the context of sti services. participants will be sti clinic patients over age 18 that have been treated for a previous sti. participants will be baseline assessed and randomized to receive either (a) the 60 min theory-based and culturally tailored risk reduction intervention or (b) a time and contact matched standard of care hiv and health education session. participants will be followed for 12 months post intervention. assessments will be conducted using computer assisted interviews (acasi). the randomized trial will determine the efficacy of the risk reduction intervention for south african men and women receiving sti clinic services. outcome analyses will include differences between conditions on new sti diagnoses over 12 months. we will also test the mediating effects of attitudes and beliefs on intervention outcomes. results of this research will therefore test a clinic-based hiv prevention intervention model that is urgently needed in south africa.

Eligibility criteria:
inclusion criteria: * 18 years and older * sti clinic patient diagnosed with an sti at current visit exclusion criteria: * none

Keywords: prevention counseling behavioral interventions hiv risk reduction
the impact of energy intake and short-term disuse on muscle protein synthesis rates and skeletal muscle mass in middle-aged adults.

Conditions: Muscle Atrophy; Aging; Energy Malnutrition Protein

Summary: in healthy middle-aged men and women, what is the effect of dietary energy restriction and energy surplus on daily muscle protein synthesis rates and muscle morphology, compared to energy balance, during free-living and immobilisation?

background age related muscle tissue loss, which is associated with a number of negative health outcomes is partially caused by blunted muscle protein synthesis rates (mps) in response to food ingestion, which is exacerbated by muscle disuse. concomitantly, consuming an energy balanced diet appears to become more challenging with advancing age, due to a reduction in appetite. of concern is that the impact of energy intake on muscle protein metabolism during ageing is poorly characterised. objective to determine daily mps and muscle morphology in response to differing energy intakes, in free-living conditions and during immobilisation. methods healthy middle-aged volunteers will consume a hypocaloric, energy-balanced, or hypercaloric diet (providing 1.4 g.kg.day protein) over a three-day free-living period, and a three day period of single leg immobilisation. deuterium oxide and mri scans will be used to measure daily mps and muscle size, respectively. value the study will determine the effect of energy intake per se on daily muscle protein synthesis rates and muscle size, in free-living and immobilised conditions. this will inform how energy provision modulates tissue loss with ageing, and how this interacts with the catabolic stress of muscle disuse.

Eligibility criteria:
inclusion criteria: age 35-65 healthy non-smoker recreationally active exclusion criteria: any diagnosed metabolic impairment (e.g. type 1 or 2 diabetes) any diagnosed cardiovascular disease or hypertension elevated blood pressure at the time of screening. (an average systolic blood pressure reading of ≥150mmhg over two or more measurements and an average diastolic blood pressure of ≥90mmhg over two or more measurements.) chronic use of diabetic medication. a personal or family history of epilepsy, seizures or schizophrenia. allergic to mycoprotein / quorn, penicillin, or cow's milk. any musculoskeletal injury that may impair their use of crutches. any diagnosed severe digestive illness. any diagnosed severe autoimmune disease. any diagnosed cancer. any metal fragments in the eyes, a pacemaker, or metal implants in the body that preclude mri scanning.

Keywords: muscle protein synthesis ageing dietary protein disuse
cross-sectional study of ultrasonic diagnosis of iliac joint capsule muscle

Conditions: Femoroacetabular Impingement; Hip Developmental Dysplasia

Summary: in order to investigate the relationship between the iliac joint capsular muscle and the development of the hip joint, this study used ultrasound doppler to measure the anatomical circumference of the iliac joint capsular muscle to explore the relationship

in order to investigate the relationship between the iliac joint capsular muscle and the development of the hip joint, this study used ultrasound doppler to measure the anatomical circumference of the iliac joint capsular muscle to explore the relationship.ultrasound was used to compare the size of the iliac joint cystic muscle in the three groups: patients with developmental dysplasia of the hip (ddh), patients with pincer type femoral hip impingement, and normal control group. the shear wave velocity and shear modulus of the iliac joint capsular muscle of three groups were compared to compare the degree of fat infiltration in muscle.

Eligibility criteria:
inclusion criteria: * ≥ 20 years; * clinically suspected of ddh or pincer and underwent surgery * understand and sign the informed consent exclusion criteria: * leggcalve´-perthes disease * muscle diseases * hip development disorder * history of progressive osteoarthritis * history of hip surgery * history of arthritis of the hip joint * with pacemaker or metal in the body
type 2 diabetes mellitus prevention ukraine

Conditions: Impaired Fasting Glucose; Impaired Glucose Tolerance; Type 2 Diabetes

Summary: development, implementation and evaluation of the effectiveness of lifestyle recommendations for the prevention of type 2 diabetes in rural population of ukraine

an oral glucose tolerance test and anthropometric measurements were performed for 300 randomly selected rural residents of the kyiv region of ukraine. persons from impaired glucose regulation category (impaired fasting glucose - ifg) was enrolled to diabetes prevention intervention study (t2dpua). individuals in the ifg category received advice on limiting sugar intake (not more than 25 g per day), increasing physical activity (30 minutes daily). 30 persons from this category were additionally advised to consume insoluble dietary fiber 15 g per day (vitacel wheat fiber) for 3 months, after which a repeat anthropometric and biochemical study. objective control of physical activity and body composition is also provided.

Eligibility criteria:
inclusion criteria: persons with fasting blood glucose level \>=6.1 mmol/l; persons aged 18-79 who signed an informed consent for the study. exclusion criteria: known diabetes; acute infectious diseases; other serious diseases

Keywords: lifestyle modification type 2 diabetes prevention ukraine rural
the mad study of ssgj-613 in healthy subjects

Conditions: Arthritis, Gouty

Summary: to evaluate the safety and tolerability of ssgj-613 after multiple subcutaneous injections in healthy subjects.

the purposes of this study are to evaluate the safety and tolerability, pk characteristics and immunogenicity of ssgj-613 after multiple subcutaneous injections in healthy subjects.

Eligibility criteria:
inclusion criteria: 1. chinese healthy participants, male or female, aged 18 to 45 (including both ends) 2. the body mass index (bmi) is in the range of 19.0\~28.0 kg•m-2 (including both ends), and the weight of men is generally not less than 50kg, while the women is generally not less than 45kg 3. participants should fully understand the purpose, nature, methods and possible adverse reactions of the trial, volunteer to participate in the trial and sign the informed consent exclusion criteria: 1. those who are allergic to the study drug and any of its excipients. subjects who have a history of allergy to monoclonal antibodies 2. subjects who have or are currently suffering from any serious clinical diseases before screening, 3. abnormal vital signs or abnormal ecgor physical examination are clinically significant 4. clinical laboratory examinations found to be abnormal and have clinical significance 5. positive for hepatitis b surface antigen (hbsag), hepatitis b core antibody (hbcab), anti- hepatitis c virus antibodies (hcv), or anti-human immunodeficiency virus (hiv) 6. alcoholics or frequent drinkers within 3 months before the trial, drinking more than 14 units per week (1 unit alcohol ≈360 ml beer or 45 ml spirits or 150 ml wine), or those who have a positive alcohol breath test (screening period or baseline period) or couldn't prohibit alcohol during the trial 7. drug abusers or those who have used soft drugs (such as marijuana) within 3 months or took hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before the trial, or have positive drug abuse screening 8. has taken any prescription medicine, non-prescription medicine, chinese patent medicine within 2 weeks before administration 9. has known or suspected pregnancy or lactation 10. subjects who are unsuited to the study for any reason, judged by the investigators
effect of hbot on femoral head avascular necrosis (avn)

Conditions: Osteonecrosis; Avascular Necrosis

Summary: the primary objective of this study is to determine whether the hyperbaric oxygen therapy (hbot) conducted under the marx protocol improves pain outcomes when combined with core decompression with autologous bone marrow aspirate concentrate to treat patients with femoral head avascular necrosis.


Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study * diagnosed with femoral head avascular necrosis * enrolled into yale avascular necrosis program * avascular necrosis lesion is classified as arco i or arco ii by investigator * surgical candidate for core decompression using 3d image guidance with bone marrow aspirate concentrate exclusion criteria: * hip has already collapsed due to severe avascular necrosis (arco iii or arco iv) * medical comorbidities that prevent them from being a surgical candidate (example: obesity) * absolute contraindications to hbot, including severe decompensated cardiac failure or lung disease putting them at high risk for pneumothorax * pregnant * prisoner * does not sign informed consent form
impact of artificial intelligence (ai) on adenoma detection during colonoscopy in fit+ patients.

Conditions: Polyp of Colon

Summary: the italian screening program invites the resident population aged 50-74 for fecal immunochemical test (fit) every 2 years. subjects who test positive are referred for colonoscopy. maximizing adenoma detection during colonoscopy is of paramount importance in the framework of an organized screening program, in which colonoscopy represent the key examination. initial studies consistently show that artificial iintelligence-based systems support the endoscopist in evaluating colonoscopy images potentially increasing the identification of colonic polyps. however, the studies on ai and polyp detection performed so far are mostly focused on technical issues, are based on still images analysis or recorded video segments and includes patients with different indications for colonoscopy. at the best of our knowledge, data on the impact on ai system in adenoma detection in a fit-based screening program are lacking. the present prospective randomized controlled trial is aimed at evaluating whether the use of an ai system increases the adr (per patient analysis) and/or the mean number of adenomas per colonoscopy in fit-positive subjects undergoing screening colonoscopy. therefore patients fulfilling the inclusion criteria are randomized (1:1) in two arms: a) patients receive standard colonoscopy (with high definition-hd endoscopes) with white light (wl) in both insertion and withdrawal phase; all polyps identified are removed and sent for histopathology examination; b) patients receive colonoscopy examinations (with hd endoscopes) equipped with an ai system (in both insertion and withdrawal phase); all polyps identified are removed and sent for histopathology examination. in the present study histopathology represents the reference standard.


Eligibility criteria:
inclusion criteria: * consecutive adult (50-74 yrs.) outpatients undergoing colonoscopy in the frame of the fit-based screening program. exclusion criteria: * patients with crc history or hereditary polyposis syndromes or hereditary non-polyposis colorectal cancer * patients with inadequate bowel preparation * patients in which cecal intubation was not achieved or scheduled for partial examinations * patients with gastrointestinal symptoms * polyps could not be resected due to ongoing anticoagulation preventing resection and pathological assessment

Keywords: adenoma detection
patient preferences for leadless pacemakers

Conditions: Cardiac Rhythm Disorder; Bradycardia; Cardiac Pacemaker Artificial

Summary: prospective, non-randomized, multi-center study designed to quantify patient preferences pertaining to risks and features of conventional transvenous pacemakers and leadless pacemakers

the purpose of this study is to quantify patient preferences pertaining to risks and features of conventional transvenous pacemakers and leadless pacemakers. the preference study is designed to elicit patient preferences for risks and features that vary between a dual chamber leadless pacemaker system and a dual chamber transvenous pacemaker system, to quantify their relative importance.

Eligibility criteria:
inclusion criteria: * able to read and speak english to consent to participate in the survey * willing and able to use a tablet or computer to complete the survey * scheduled to undergo evaluation for a de novo cardiac pacemaker at the study site (patient may or may not have a known indication for a pacemaker at the time) exclusion criteria: * none