Kornimate/medical-research-clean huggingface dataset:
hypoxic exercise in lower extremity artery disease

Conditions: Peripheral Arterial Disease

Summary: the aim of this randomized controlled trial is to: phase i: to explore, in a first pilot phase, the adequate combination of hypoxia severity and exercise intensity in patients with symptomatic lower extremity artery disease (lead). acute walking performances and physiological responses (vascular and muscular) to a normobaric hypoxic exercise performed will be assessed at two different altitudes (1500 m and 2500 m).

the results of this first phase will then be used to determine the optimal hypoxic level for the exercise training program which will be assessed during the phase ii.

Eligibility criteria:
inclusion criteria: * patients with symptomatic lead (fontaine stage ≥ iia) * abi ≤ 0.9 * tbi ≤ 0.6 if incompressible arteries (diabetes and renal insufficiency) * signed written informed consent form exclusion criteria: * neurological and neuromuscular disorders which can limit balance and walking * any history of altitude-related sickness * any health risks (assessed during clinical history) linked to hypoxia exposure * acclimatization or exposure to hypoxia of more than 2000 m for more than 48 h during a period of 6 months before the study * medication required for the treatment of migraines, claustrophobia that may interfere with the interpretation of the results * obstructive sleep apnea (\> 25 apnea-hypopnea index) * prior leg/foot amputation * pregnant women * cardiac contraindication to exercise

Keywords: exercise cardiovascular normobaric hypoxia
utility of versican and hyaluronan measurement in induced sputum as biomarkers of asthma

Conditions: Allergic Asthma

Summary: the purpose of this study is to determine the role of versican and hyaluronan measurements in induced sputum as biomarkers of asthma. enroll 10 subjects with mild persistent asthma who are not receiving treatment with a controller therapy.

we will compare spirometry, eno and sputum measurements of versican and hyaluronan before and after treatment with fluticasone 220 ug/bid.

Eligibility criteria:
inclusion criteria: * allergic asthma defined as a positive methacholine challenge exclusion criteria: * non-atopic patients

Keywords: versican hyaluronan sputum
evaluation of a smartphone-based screening tool (picterus jp) for neonatal jaundice (chicago)

Conditions: Neonatal Jaundice

Summary: a cross-sectional conductive study at the university of chicago medicine facilities (hospital and outreach clinics) to enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using picterus jp.

a cross-sectional conductive study at the university of chicago medicine facilities (hospital and outreach clinics) will be conducted to include a total of 250 newborns with a desired distribution of skin color according to neomar's scale : skin color 1 and 2: 20%, skin color 3: 30% and skin color 4: 50%. skin color may also be quantitatively assessed using a handheld spectrophotometer (cm-700d, konica minolta). the picterus calibration card will be placed on the chest of the newborn with the hole in the card placed over the infant's chest. a validated smartphone with picterus jp will be used to collect digital images, which are analysed to calculate a picterus bilirubin value.

Eligibility criteria:
inclusion criteria: * infants born with gestational age \&gt; 35 weeks. * birth weight ≥ 1800 grams * age 1 - 14 days * infants requiring a tsb blood sample for clinically suspected jaundice as part of standard care exclusion criteria: * infants showing signs of inborn disease. * infants with skin rash or other skin disease that affects the skin where measurements are performed. * infants transferred to the pediatric ward for medical treatment. * infants that have received phototherapy in the last 24 hours
psychosocial risk factors in stroke and myocardial infarction

Conditions: Myocardial Infarction; Stroke

Summary: the aim of this study is to identify groups of subjects at risk of recurrence in secondary prevention based on psychosocial factors. the aim is also to propose novel levers to reduce health inequalities in this population so as to develop new prevention strategies for neuro- and cardio-vascular health this study is based on data from questionnaires (quality of life at work, perceived stress, perceived disease severity) and on behavior indicators (factors related to lifestyle: alcohol, smoking, obesity, sedentarity). biomarkers of endothelial function (adma) will also be assayed. it's an interventional study because of blood sample


Eligibility criteria:
inclusion criteria: * patients who have provided oral consent to participate * patients over 18 years * patients hospitalized for type 1 mi or ischemic stroke/tia \< 24h after symptom onset * age \< 65 years * with a professional activity (insee definition) at the time of the neuro or cardiovascular event * at least one of the following risk factors: current smoking, obesity (waist circumference \> 88 cm (w)/102 cm (m) or a waist/hip ratio 0.85(w)/0.9(m), sedentarity (physical activity \ 3 standard glasses per day for men, \> 2 standard glasses/d for women) exclusion criteria: * adult under guardianship * patients without national health insurance cover * pregnant or breast-feeding women * clinical state making it impossible to use questionnaires or to measure risk factors * stroke or tia not related to atheroma or cardioembolism (dissection, hemopathy...) * type \> 1 mi
study of efficacy of a vasopressin 2 receptor antagonist m0002 for treatment of ascites in cirrhotic subjects with hypo- or normonatraemia

Conditions: Cirrhotic Ascites

Summary: m0002, an orally active, selective non-peptidergic antagonist of the vasopressin v2 receptor inhibits vasopressin-induced water reabsorption from the kidney. therefore the aquaretic effect of m0002 has a potential clinical benefit in the treatment of ascites and hyponatreamia in cirrhotic patients.


Eligibility criteria:
main inclusion criteria: 1. subjects with any form of cirrhosis with ascites and who had at least 1 paracentesis of at least 4 liter in the last 6 months. 2. dose of diuretics of spironolactone and furosemide was to be stable for at least one week prior to the screening visit or subject was refractory to diuretics. 3. subjects had to have been on a salt restricted diet (\< 5.2 grams sodium/day, 90 mmol) during the screening period prior to the trial drug administration. 4. other treatment for the management of cirrhosis and ascites should be stable for at least 2 weeks prior to trial drug administration. 5. child-pugh b and c liver cirrhosis score lower than 12. 6. subjects with hyponatraemia with sodium level between 120 and 132 mmol/l or normonatraemia with sodium level between 133 and 145 mmol/l measured at screening visit and day 1. main exclusion criteria: 1. women of child bearing potential (wocbp) 2. functional transjugular intrahepatic portasystemic stent shunt (tips), peritoneovenous shunt 3. liver transplantation 4. budd-chiari syndrome 5. unstable hepatic disease (acute hepatitis, ast or alt \> 5 x upper limit of normal, bilirubin \> 10 mg/dl)
social support intervention for addiction recovery

Conditions: Alcohol; Harmful Use; Alcohol

Summary: the purpose of this research study is to determine whether using a web-based intervention is feasible, acceptable, and helpful for people who engage in hazardous alcohol use and want to cut down or quit.

this pilot study will determine the feasibility and acceptability of a novel online social support intervention (let's do addiction recovery together!, abbreviated as ldart) that uses pre-recorded videos created by members of recovery support services to help individuals in early recovery from hazardous alcohol use sustain motivation during recovery and introduce them to freely available recovery support services in the community. the investigators will recruit participants to use the web-based intervention daily for a month; they will also fill in questionnaires about their substance use and engagement with recovery support services at the beginning and end of the study to determine preliminary efficacy.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * is at the time of study participation residing in connecticut, usa * is fluent in english and has a 6th grade reading level or higher * alcohol use disorders identification test (audit) score of ≥8 * has had at least one heavy drinking day in the past month * has some desire to cut down or quit their alcohol use * has a smartphone or computer with access to internet exclusion criteria: * has vulnerable population status (e.g., pregnant people, prisoners) * is at the time of study participation receiving in-patient psychiatric treatment involving hospitalization
open-label study of axs-07 for the acute treatment of migraine in adults with a prior inadequate response to an oral cgrp inhibitor (emerge)

Conditions: Migraine

Summary: this is a multicenter, open-label trial to evaluate the efficacy and safety of axs-07 in subjects with migraine attacks and prior inadequate response to oral cgrp inhibitors.

eligible subjects will receive open-label axs-07 for up to 8 weeks for at-home treatment of their next 4 migraine attacks.

Eligibility criteria:
inclusion criteria: * has an established diagnosis of migraine with or without aura * has experienced an inadequate response to oral cgrp inhibitors for the acute treatment of migraine exclusion criteria: * pregnant, breastfeeding, or planning to become pregnant during the study * has previously received any investigational drug or device or investigational therapy within 30 days before screening

Keywords: migraine axs-07 meloxicam rizatriptan oral cgrp inhibitor
iron-fortified flavoured skimmed milk with or without vitamin d in iron deficient women

Conditions: Iron Deficiency

Summary: iron deficiency and vitamin d deficiencies are common in menstruating women. the present assay studied the influence of the consumption of a flavoured skimmed milk with iron (iron pyrophosphate) or with iron and vitamin d3 in iron deficient women on: * iron metabolism * biomarkers of bone remodelling * cardiovascular risk indexes


Eligibility criteria:
inclusion criteria: * non-smoker or smokers of ≤ 3 cigarettes/day * non-pregnant * non-breast-feeding * serum ferritin \<30ng/ml * haemoglobin ≥11g/dl exclusion criteria: * amenorrhea * menopause * any known health problems likely to influence iron status including iron-metabolism-related diseases (iron deficiency anaemia, thalassaemia, haemochromatosis) * chronic gastric diseases (inflammatory bowel disease, crohn disease, gastric ulcers, celiac disease, hemorrhagic diseases) * renal disease or allergy to some of the components of the assay diary product. * blood donors * have regularly consumed iron or ascorbic acid supplements within the four months prior to participating in the intervention.

Keywords: iron deficiency menstruating women vitamin d functional food
a study to investigate the safety and effect of the study drug (fe 204205) in patients with cirrhotic portal hypertension

Conditions: Portal Hypertension

Summary: the purpose of this trial is to investigate safety, tolerability, pharmacodynamics (pd), and pharmacokinetics (pk) after intravenous (iv) administration of fe 204205 in patients with cirrhotic portal hypertension.

the trial aimed to evaluate the safety, tolerability, pk and pd of iv fe 204205 in cirrhotic patients with portal hypertension and was planned in 2 parts: part 1 of the trial was open-label where six subjects were planned to receive three ascending doses of fe 204205, given as infusion over 2 hours on three consecutive days. part 2 was planned as a randomised, placebo-controlled, double-blind investigation evaluating the effects of a single dose of fe 204205 on portal haemodynamics in 20 subjects who would have received either the maximum tolerated dose (as defined in part 1) of fe 204205 (n=16) or placebo (n=4).

Eligibility criteria:
inclusion criteria: * confirmed evidence of cirrhosis * from medical history anticipated hepatic venous pressure gradient greater than equal to (≥)12 mmhg exclusion criteria: * co-existing disease e.g. significant organ failure and decompensated cirrhosis * type 1 hepatorenal syndrome * acute-on-chronic liver failure * hepatic encephalopathy ≥grade 2 * hepatocellular carcinoma * history of underlying chronic heart disease * use of vasopressin or terlipressin within 7 days prior to dosing
study of laparoscopic inguinal hernia repair

Conditions: Hernia, Inguinal; Inguinal Hernia, Direct; Inguinal Hernia, Indirect; Hernia, Femoral; Recurrence; Neuralgia, Atypical; Neuralgia, Ilioinguinal; Neuralgia, Iliohypogastric Nerve

Summary: although mesh fixation has been associated to an increased incidence of nerve injury and involves increased operative costs, many surgeons feel that fixation is necessary to reduce the risk of hernia recurrence. the aim of this study is to evaluate the outcomes of laparoscopic herniorrhaphies performed with and without mesh fixation at our institution.

a randomized prospective study was conducted. four groups of patients were constituted: (1) tep with mesh fixation (2) tep without fixation, (3) tapp with mesh fixation, (4) tapp without fixation. 120 patients were randomized to each group. the principal outcomes assessed were postoperative chronic groin pain assessed by visual analogue pain scale (vas), hernia recurrence, other morbidity rates and hospital costs. patients were reviewed in outpatient unit at 1 week and at 1, 6, 12 and 24 months.

Eligibility criteria:
inclusion criteria: * unilateral hernia * uncomplicated hernia * medical fitness for general anesthesia exclusion criteria: * unfit for general anesthesia * complicated hernia * uncorrectable coagulopathy * bmi \> 35 * concomitant pathologies requiring simultaneous surgery * bilateral hernia

Keywords: laparoscopic inguinal hernia repair total extraperitoneoscopic hernia repair transabdominal preperitoneal hernia repair inguinal hernia laparoscopy hernia repair herniorraphy laparoscopic surgery
scarpa´s fascia in the formation of seroma post abdominoplasty after bariatric surgery

Conditions: Seroma

Summary: 46 female postbariatric patients will be submitted to anchor-line abdominoplasty with drains insertion. patients will be randomized to two groups. one group will have the fascia scarpa removed and in the other the fascia scarpa will be preserved. the drains will be removed when the volume is less than 30 ml in 24 hours. the primary outcome will be the volume of total drainage obtained in the drains of the abdominal region. secondary outcomes will be the length of time the drains remain and the presence of seroma assessed by ultrasound on the twentieth postoperative day.

morbid obesity has been increasing in brazil and the world and bariatric surgery is the most effective and long-lasting treatment. this leads to large weight losses leading to large body deformities due to excess skin and subcutaneous tissue. the most common post-bariatric plastic surgery is post-bariatric abdominoplasty which main complication is seroma. purpose: to evaluate the effect of scarpa fascia preservation in seroma reduction. methods: a total of 46 patients were randomly assigned to two groups. one group will have the fascia scarpa removed and in the other the fascia scarpa will be preserved. the drains will be removed when the volume is less than 30 ml in 24 hours. the primary outcome will be the volume of total drainage obtained in the drains of the abdominal region. secondary outcomes will be the length of time the drains remain and the presence of seroma assessed by ultrasound on the twentieth postoperative day.

Eligibility criteria:
inclusion criteria: * bmi between 22 and 30 kg/m2 * female post-bariatric patient exclusion criteria: * neoplasms * diabetes * lymphatic system diseases * abdominal scars except c section and bariatric surgery scars * mental disorders

Keywords: abdominoplasty,seroma,bariatric surgery
risk factors for failure after single-incision sling procedure in women with stress urinary incontinence

Conditions: Stress Urinary Incontinence

Summary: the main risk factors for failure after single-incision slings are reduced urethral mobility and stress urinary incontinence severity in long-term follow-up.

the medical records of the 132 patients were retrospectively analyzed. preoperative assessment included medical history and urogynecological examination. patients were asked to answer validated questionnaires such as urinary distress inventory (udi-6) and incontinence impact questionnaire (iiq-7). objective cure of sui was defined as the absence of demonstrable leakage of urine on the cough stress test. subjective cure was based on negative response to udi-6, question 3. patients were divided according to objective cure rate into two groups: cured (group a) and failed patients (group b).

Eligibility criteria:
inclusion criteria: women who underwent single-incision sling procedure for stress urinary incontinence exclusion criteria: urodinamically proven detrusor overactivity neurogenic bladder previous anti-incontinence surgery including midurethral slings postvoidal residual volume (pvr) \>100ml previous radical pelvic surgery anterior pelvic organ prolapse greater than stage i

Keywords: single-incision sling stress urinary incontinence failure
study to evaluate the effect of slv320 in addition to chronic furosemide treatment on renal function in subjects with congestive heart failure and impaired renal function

Conditions: Congestive Heart Failure

Summary: this is a randomized, double-blind, placebo-controlled, multi-center, sequential cohort study in subjects with congestive heart failure (chf) and impaired renal function who are on stable furosemide treatment (³ 40 mg daily). a total of 50 subjects will be randomized to each increasing dose level of slv320 or placebo in a sequential fashion.


Eligibility criteria:
inclusion criteria: * male and female subjects aged 18 to85 years who gave written informed consent. * subjects must have a history of chronic, symptomatic, new york heart association (nyha) class ii-iii chf and impaired renal function (baseline egfr of 20 to 75 ml/min/1.73m2). * congestive heart failure should have been diagnosed at least 3 months before visit 1 (day 1) and the subjects should be on chronic treatment with furosemide (40 mg daily) for at least 3 weeks before visit 1 (day 1). * subjects must be on stable doses of their individually optimized medication regimen for at least 4 weeks before visit 1 (day 1). exclusion criteria: * any history of a convulsive disorder or pre-convulsive state and any risk for a convulsive disorder or pre-convulsive state (for example any past brain trauma, abuse of alcohol) will lead to an exclusion from the study. * females of childbearing potential not using specified contraception, subjects with malignant tumors with a short life expectancy, subjects with known severe reactions to drugs and subjects with bilateral renal artery stenosis will be excluded from the study.

Keywords: congestive heart failure impaired renal function
bifidobacterium supplementation for very low birth weight infants

Conditions: Preterm Infants

Summary: probiotic supplementation to preterm infants have been reported to be beneficial in neonatal intensive care unit (nicu). our pilot study also showed accelerated feeding in preterm infants who received bifidobacterium bifidum early after birth. in order to evaluate these beneficial effects of bifidobacterium bifidum, a prospective randomized control study is conducted. the hypothesis of the study is that bifidobacterium bifidum supplementation to preterm infants improve enteral feeding and growth in very low birth weight infants.


Eligibility criteria:
inclusion criteria: * infants with birth weight less than 1500g exclusion criteria: * sever bacteremia * congenital anomaly * not suitable for the trial defined by an attending neonatologist

Keywords: probiotics preterm infants enteral feeding bifidobacterium on enteral feeding
efficacy and safety of ly451395 in patients with probable alzheimer's disease

Conditions: Alzheimer's Disease

Summary: study of an investigational medication for the treatment of alzheimer's disease in patients who are not taking aricept, reminyl, exelon.


Eligibility criteria:
inclusion criteria: * must have a clinical diagnosis of alzheimer's disease * must be at least 50 years of age * must fluently read and speak english * must have a reliable caregiver exclusion criteria: * has serious health problems other than alzheimer's disease * cannot swallow whole pills * has had a menstrual period in the last two years * takes insulin for diabetes * has taken aricept, reminyl, or exelon in the last 5 weeks

Keywords: alzheimer's disease
screening of gastric cancer via breath volatile organic compounds by hybrid sensing approach

Conditions: Gastric Cancer; Atrophic Gastritis; Gastric Dysplasia; H.Pylori Infection

Summary: the study is aimed to determine the potential of volatile marker testing for gastric cancer screening. the study will be addressing the role of confounding factors, including lifestyle factors, diet, smoking as well as addressing the potential role of microbiota in the composition of exhaled volatile markers.

patients with established disease (gastric cancer, precancerous lesions) as well as patients investigated for the lesions and having been documented lack of the lesions will be enrolled to the study at clinical sites in europe (latvia, ukraine) and latin america (colombia, chile, brazil). in addition, group of persons from general population at average risk for developing the target disease and individuals being referred for upper endoscopy according to clinical indications will be also enrolled. testing of volatile markers will be conducted by one of two methods: 1) gas chromatography coupled to mass spectroscopy (gs-ms) and 2) sensor technology. various sensors will be used and evaluated for the purpose. the potential sources of volatile organic compounds (vocs) in the breath will be addressed by studying voc emission by using headspace analysis from cancer tissue, gastric contents, cancer cell cultures and h.pylori. the potential role of gastric and faecal microbiota in the origin of vocs in the breath will be addressed. metabolome in the circulation will also get correlated to vocs in the breath and with microbiome.

Eligibility criteria:
inclusion criteria: * patients with verified gastric cancer (group 1 \& 2) * patients undergoing or having undergone upper endoscopy according to clinical indications (group 3 \& 5) * average-risk population group aged 40-64 at inclusion without alarm symptoms (group 4) * motivation to participate in the study * physical status allowing volatile marker sampling and other procedures within the protocol * signed consent exclusion criteria: * known other active cancer * ventilation problems, airway obstruction * unwillingness or inability to co-operate

Keywords: volatile organic compounds breath testing gastric cancer atrophic gastritis precancerous lesions screening nanosensor technology gc-ms
safety and efficacy of spd503 in treating attention-deficit/hyperactivity disorder (adhd) in children aged 6-17

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: the purpose of this study is to assess the safety and efficacy of spd503 (guanfacine hydrochloride) compared to placebo in the treatment of adhd in children and adolescents aged 6-17


Eligibility criteria:
inclusion criteria: * subjects with a primary diagnosis of adhd * male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements exclusion criteria: * subject has current uncontrolled comorbid psychiatric diagnosis (except odd) with significant symptoms * history of seizure during the last 2 years * subject has any specific cardiac condition or family history of significant cardiac condition * subject is pregnant or lactating