Kornimate/medical-research-clean huggingface dataset:
eu post market clinical follow-up study of the venclose system for saphenous vein incompetence

Conditions: Chronic Venous Insufficiency

Summary: this is a prospective, non-randomized study in which patients who meet eligibility criteria and consent to participate will undergo a minimally invasive procedure using radiofrequency (rf) energy for ablation of the great saphenous vein (gsv).

subjects who meet eligibility criteria will undergo a procedure using the venclose radiofrequency (rf) system to treat the great saphenous vein. the technique involves percutaneous access and insertion of the endovenous sectional radiofrequency (evsrf™) catheter into the target vein under ultrasound guidance and relies on the use of local anesthesia and thermal energy, from a radiofrequency generator, applied to the target vein. after each treatment, the evsrf™ catheter is withdrawn a single length of the heating coil and another treatment is performed, until the entire vessel has been treated. after the treatment procedure, subjects will be evaluated four (4) times to assess vein recanalization and reflux, and to determine the incidence of adverse events.

Eligibility criteria:
inclusion criteria: * subject is male or female and 18 to 80 years old (inclusive) at time of enrollment (signing of consent). * subject has significant venous reflux by duplex ultrasound (dus), defined as reverse flow with reflux duration greater than 0.5 seconds after the valsalva maneuver or distal augmentation while the patient is standing or in reverse trendelenburg position. * subject is eligible for endovascular treatment, as determined by the treating investigator. * subject's general physical condition allows for a significant amount of ambulation after the procedure, as determined by the treating investigator. * subject is willing and able to complete study requirements, including all follow-up visits and assessments. * subject voluntarily provides written informed consent to participate in this study. exclusion criteria: * there is evidence of old or fresh thrombus in the subject's diseased vein segment to be treated, as determined by duplex ultrasound (dus) within 2 weeks prior to the index procedure. * in the judgment of the treating investigator heat energy delivery to the subject would be contraindicated. * subject is concurrently participating in another interventional clinical trial. * subject is pregnant or plans to be pregnant or lactating at the time of the treatment procedure. * subject has known or suspected allergies or contraindications to any general or local anesthetic agents and/or any antibiotic medication that cannot be adequately pre-treated.

Keywords: gsv superficial vein reflux venous reflux venous insufficiency varicose veins
topical 5% tranexamic acid as a treatment for postinflammatory hyperpigmentation due to acne vulgaris

Conditions: Postinflammatory Hyperpigmentation

Summary: the goal of this study is to determine if topical tranexamic acid is capable of decreasing the pigment of the dark spots left from acne bumps. the first line medication used for this often is not tolerated well by patients, and topical tranexamic acid has minimal reported side effects thus far.


Eligibility criteria:
inclusion criteria: * age 18 to 65 * patients with bilateral involvement of facial postinflammatory hyperpigmentation due to acne vulgaris. exclusion criteria: * pregnant patients or patients planning to become pregnant during the time of the study. * patients with a history of use of hydroquinone, kojic acid, tretinoin, adapalene, tazarotene or azaleic acid in the previous 3 months.

Keywords: postinflammatory hyperpigmentation acne
alto-300 in depression (alto-300-004)

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to collect biologically-based data for defining predictors and correlates of the effects of alto-300.


Eligibility criteria:
inclusion criteria: * have a diagnosis of moderate to severe major depressive disorder * currently taking a ssri, snri, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks * must have failed to adequately respond to the current antidepressant medication * willing to comply with all study assessments and procedures * must not be pregnant or breastfeeding at time of enrollment or throughout study exclusion criteria: * evidence of liver impairment or disease * active suicidal ideation * moderate to severe alcohol use disorder * diagnosed bipolar disorder or psychotic disorder * has a history of hypersensitivity or allergic reaction to alto-300 or any of its components/excipients * concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device
effects of different ventilatory strategy on intraoperative atelectasis during bronchoscopy under general anesthesia.

Conditions: Lung Disorder

Summary: this trial compares two different types of ventilation for the prevention of partial or complete collapsed lung (atelectasis) in patients undergoing interventional pulmonology procedures under general anesthesia. ventilatory strategy to prevent reduce the intra-procedural development of atelectasis during interventional pulmonology procedures under general anesthesia.


Eligibility criteria:
inclusion criteria: * adult patients undergoing interventional pulmonology procedures with radial probe endobronchial ultrasound (rp-ebus) for peripheral lung lesions * recent (\< 4 weeks) chest computed tomography (ct) performed prior to the bronchoscopy exclusion criteria: * patients with baseline lung consolidation, interstitial changes or lung masses (\> 3 cm in diameter) in dependent areas of the lung (right/left \[r/l\] b6, 9, or 10 bronchial segments) as seen on most recent ct * history of primary or secondary spontaneous pneumothorax

Keywords: atelectasis general anesthesia
sarcopenia and short bowel syndrome

Conditions: Short Bowel Syndrome

Summary: sarcopenia or the loss of skeletal muscle is highly prevalent in many diseases, including short bowel syndrome (sbs). while adaptation is more likely in sbs patients with a colon-in-continuity, the consequences and underlying mechanisms are unclear. an overabundance of fecal lactobacillus was found but not yet linked to adaptation or sarcopenia. the objectives are to study the evolution of sarcopenia and the link with intestinal adaptation in sbs.

patients with short bowel syndrome (sbs) will be screened and included in longitudinal or cross-sectional studies if eligible. the longitudinal study will follow patients with type 1 sbs (enterostomy) before and every 3 months after continuity surgery for 1 year. cross-sectional studies will follow patients with type 2 or 3 sbs (jejunocolonic or -ileal anastomosis) for 1 year (every 3 months during the first 2 years after continuity surgery or every 6 months after). study visits will include clinical examination, nutritional assessment, endoscopy with biopsies and/or intestinal absorption assessment planned as part of routine follow-up. in addition, questionnaires will be completed (gpaq, sarqol, eq-5d -3l, sf36), with collection of stool (for routine and research) and urine samples (for research). the objective are to study the evolution of sarcopenia and the link with intestinal adaptation in sbs. the results may identify metabolic or microbial biomarkers and predictors of nutritional optimisation in sbs, which is a complex and costly orphan disease.

Eligibility criteria:
inclusion criteria: * age ≥18 years old * sbs diagnosis validated by small bowel length and either type 1 (enterostomy), type 2 or 3 (jejuno-colic or -ileal anastomosis) * patient not objecting to the collection of personal data as part of the study exclusion criteria: * pregnancy * remaining hail length unknown * patient expressing opposition to participating in the cohort * patients who are unable to express themselves

Keywords: sarcopenia short bowel syndrome adaptation
food effects on the relative bioavailability of different dosages of risedronate

Conditions: Postmenopausal; Non-lactating; Surgically Sterile

Summary: randomized, open-label, multi-center, 4-treatment, 4-period crossover study. the study will consist of a screening visit, study center admission (preceding treatment periods 1, 2, 3, and 4), 4 treatment periods (4 days each), 3 washout periods (14 to 17 days in duration separating each treatment period), and exit procedures.


Eligibility criteria:
inclusion criteria: * non-lactating and either surgically sterile or postmenopausal: * body mass index less than or equal to 32 kg/m2 at screening exclusion criteria: * no use of a bisphosphonate within 1 month * no history of gi disease * no use of any medications within 7-14 days prior to scheduled dosing day

Keywords: bioequivalence
preliminary study concerning the validity of parathyroid exploration on a czt camera

Conditions: Primary Hyperparathyroidism

Summary: the goal of this study is to assess the performance of parathyroid imaging on a cardiac-dedicated czt camera, compared to planar pinhole imaging, in patients referred for primary hyperparathyroidism.

the goal is to determine if parathyroid tomoscintigraphy on a czt camera can provide at least equivalent diagnostic performance, compared with planar pinhole imaging.

Eligibility criteria:
inclusion criteria: * suffering from sporadic primary hyperparathyroidism * referred to the nuclear medicine dept for a pre-operative scintigraphy of the parathyroid glands * who have given their written consent * who benefit from the french government medical insurance exclusion criteria: * pregnant women * ages \ 80 years * hyperparathyroidism recidive after a first surgery * secondary or tertiary hyperparathyroidism * multiple endocrine neoplasia (men) type i context or familial history of hyperparathyroidism * absence of written consent * non-beneficiary of the french government medical insurance

Keywords: czt camera pinhole
evaluate the effect of growth hormone (gh) treatment on fibroblast growth factor 23, a known phosphaturic agent

Conditions: Growth Disorders

Summary: the purpose of this study is to evaluate the effect of growth hormone treatment on phosphorus levels in the body. phosphorus is an important mineral for bone growth. it is well known that growth hormone treatment improves bone density and bone mineral content. the amount of phosphorus is maintained by the kidneys. fibroblast growth factor 23 has recently been recognized to help kidneys control phosphate levels.

this study will compare fibroblast growth factor 23 levels in children with and without growth hormone deficiency. children with growth hormone deficiency will have levels taken before starting growth hormone replacement and after it has been initiated.

Eligibility criteria:
inclusion criteria: * twenty children with significant short stature \< 3rd percentile, ages 3-14 years, and referred to children's hospital of alabama * normal healthy volunteer children 3-18 years with normal stature exclusion criteria: * patients on medication including gh * patients with concomitant hormonal abnormalities * patients with disorders of calcium and phosphate metabolism * active neoplasms * closed epiphysis * known bone disorders

Keywords: fibroblast growth factors bone development
skin dressings versus lubrication to prevent pressure ulcers: a randomized trial

Conditions: Pressure Ulcer

Summary: study purpose: to assess if - in adult patients admitted to hospital with surgical or medical conditions at high/very high risk of developing pressure ulcers (pu) according to braden scale - using skin dressing protection versus conventional care (lubricant or moisturizer cream) may prevent the incidence of in-hospital pu

participants will receive, in addition to the experimental/control interventions, background skin care measures, including anti- bedsore mattresses; body position changes every two hours, and shear/friction reduction. trained nurses will review all participants' charts and verify any report of pu until the first ambulation, discharge or death. patients with a verified pu are referred to the institutional wound care group. for the purpose of outcome adjudication, study personnel will email digital pictures to 2 independent, blinded outcome assessors (experts in skin care). skin lesions will be rated in 4-level scale (epuap/npuap). in case of disagreement, a single, independent referee will confirm the presence/absence of any potential pu. the unit for analysis will be patients developing (first occurrence, in a time-to-event analysis) pus in the areas covered by the interventions. see further details on eligibility, interventions and study outcomes below

Eligibility criteria:
inpatients will be eligible if meeting two criteria: * intact skin on hospital admission * high/very high risk of pu (braden´s scale ≤ 20 points) will be eligible. exclusion criteria: * treating physician disagree with participation * need for chronic use of diapers

Keywords: prevention pressure ulcers clinical trial nursing
evaluation of a combined strategy addressed to practitioners and chronic obstructive pulmonary disease (copd) patients to improve clinical control and quality of life

Conditions: Chronic Obstructive Pulmonary Disease

Summary: main objective: evaluate the effectiveness of a combined strategy addressed to health care workers and patients, in relation to improving clinical control and patient's quality of life.it includes a feed-back about the health status of the patients, an education plan addressed to practitioners based in a cpg and in health education

method/design: design: multicenter intervention study(before-after), quasi-experimental, prospective, with a control group and 12 month's follow-up setting: 21 primary health care centres in barcelona (spain) sample: 801 patients (≥ 40 years old) with a register of copd diagnostic,with one visit motivated by copd during 2003 and that accept to participate at the study, after having read and signed the informed consent. intervention: the program includes giving clinical results to the health care workers(doctor and nurse), from the medical records and interview. a training course (20h)that deals with aspects related to gpc, motivational interview and health education (tobacco, inhalers, alimentation, exercise and physiotherapy). main variables: socio-demographic characteristics, quality of life, dyspnea, pharmacological treatment, exacerbations and hospital admissions, evaluation of inhalers technique, tobacco consumption, lifestyles and health resources used. measures: quality of life was evaluated with the saint george's respiratory questionnaire (sgrq) and dyspnea with the modified scale of the medical research council (mrc). the variables are obtained at the beginning of the intervention and at the end (12 months after). information about possible changes in lifestyle is gathered during the follow-up visits.

Eligibility criteria:
inclusion criteria: * patients of both genders aged ≥40 years of age, recorded as having copd, receiving attention in the pcc or at home, who have had at least one clinical visit for copd management, and who provide written informed consent to participation in the study. exclusion criteria: * patients who have any psychiatric disturbances, severe visual or auditory impairment that would impede compliance with the study protocol. * patients with asthma, tuberculosis or other chronic respiratory pathologies, or any end-stage disease, or not having access to a telephone.

Keywords: chronic obstructive pulmonary disease quality of life primary health care
multi-reader retrospective study examining carebot ai cxr 2.0.21-v2.01 implementation in everyday radiology clinical practice

Conditions: Pneumothorax; Pulmonary Nodule, Solitary; Atelectasis; Subcutaneous Emphysema; Cardiomegaly; Consolidation; Pleural Effusion

Summary: the primary objective is to evaluate the performance parameters of the proposed dlad (carebot ai cxr) in comparison to individual radiologists.

in the period between october 18th, 2022, and november 17th, 2022, anonymized chest x-ray images of patients were collected at the radiodiagnostic department of the havířov hospital, p.o. the collection process involved utilizing the cloudpacs imaging and archiving system provided by or-cz spol. s r.o. the collected x-ray images were subjected to the proposed dlad (carebot ai cxr) for analysis. subsequently, the dlad's performance was compared with the standard clinical practice, where radiologists assessed the cxr images in the simulated hospital setting with access to standard viewing tools (e.g., pan, zoom, ww/wl) and were given an unlimited amount of time to complete the review. each radiologist determined the presence or absence of 7 indicated radiological findings, including atelectasis (ate), consolidation (con), pleural effusion (eff), pulmonary lesion (les), subcutaneous emphysema (sce), cardiomegaly (cmg), and pneumothorax (pno).

Eligibility criteria:
inclusion criteria: * hospital patients \> 18 years who were referred for chest radiography october 18th, 2022, and november 17th, 2022 at the radiodiagnostic department of the havířov hospital, p.o. exclusion criteria: * patients \< 18 years * chest x-ray images in lateral positions * duplicated chest x-ray images

Keywords: artificial intelligence computer-aided detection deep learning chest x-ray radiology
unraveling a potential connection between bilirubin metabolism, gut microbiota and inflammatory bowel diseases

Conditions: Colitis, Ulcerative; Crohn Disease

Summary: inflammatory bowel diseases (ibds) are a set of recurrent inflammatory conditions that include the colon and small intestine. the two principal conditions include crohn's disease (cd) and ulcerative colitis (uc). the etiology of which is likely to stem from the interplay of gut microbial imbalances and host. in this study stool cultures, saliva and skin samples will be taken from all participants.

recent studies have shown that certain cd patients harbor microbial communities that are distinct from those of healthy individuals. these studies suggest a central role of the gut microbial population in cd. the high complexity of the gut microbiome, which is the most densely populated bacterial niche, makes the identification of these bacteria a significant challenge. the bacterial population is comprised from 1013 - 1014 individuals, all belonging roughly to a thousand different species, mostly anaerobic, and most of them (roughly 70% - 80%) are uncultivable. the goals of this project are to examine a potential link between bilirubin metabolism and ibd, by comparing fecal extracts from healthy humans and ibd patients, and to investigate the underlying mechanism explaining these differences.

Eligibility criteria:
inclusion criteria: * uc * cd * healthy volunteers exclusion criteria: • n/a
double-blind placebo controlled study of oxytocin in fragile x syndrome

Conditions: Fragile X Syndrome

Summary: the purpose of this study is to determine whether the medication oxytocin is an effective and tolerable treatment in adolescent males with fragile x syndrome (frax) for improving socially appropriate behaviors and reducing social anxiety.

twelve male adolescent (13-24 years) subjects with confirmed genetic diagnosis of frax (full mutation) will participate in this randomized double-blind placebo-controlled study. they will receive a dose of either 24 iu oxytocin, 48 iu oxytocin or placebo at each of three visits to the lab, with each visit spaced one week apart. the efficacy of each dose will be evaluated using behavioral, cognitive and physiological metrics. if individual subject results suggest that either of the oxytocin dosage levels (24 iu or 48 iu) is superior to placebo in the double-blind phase, a single-blind trial using the optimal dosage of oxytocin will then be administered daily for 14 days by parents at home. subjects will then come into the lab for a final assessment on day 30. determination of beneficial response to oxytocin will be based on a 20% change (improvement) in behavior or test performance (see below). if both oxytocin dosage levels provide similar benefits compared to placebo, the lower dose will be chosen for the 14 day single-blind trial.

Eligibility criteria:
inclusion criteria: 1. confirmed genetic diagnosis of fragile x (frax) (full mutation). 2. male (who have more serious effects due to the x chromosome nature of the disorder) 3. age 13-29 years. 4. parent of adolescent must be willing to sign informed consent. 5. intelligence quotient (iq) \> 42. exclusion criteria: 1. cardiac risk factors. 2. medication exclusions: opiates or opiate antagonists, corticosteroids, typical or atypical antipsychotics.
study to compare the effect of ropinirole prolonged release once-daily versus twice-daily

Conditions: Parkinson Disease

Summary: 1. in order to compare the benefit, side effects, and patient preference of ropinirole prolonged release when used in once-daily or twice-daily dosing 2. in order to estimate the conversion rate of dopamine agonists into ropinirole prolonged release

1. study subjects : parkinson disease who are on ropinirole immediate release or pramipexole immediate release and are considering to change into ropinirole prolonged release 2. cross over study design: * group 1: once daily dose for 2 month then into twice daily in divided dose for 2 months * group 2: twice daily in divided dose for 2 months then into once daily dose for 2 months 3. dose adjustment may be done in the first 4 weeks. 4. compare the benefit,side effects, and patient preference between the once daily vs twice daily dosing.

Eligibility criteria:
inclusion criteria: 1. age: 30-80 2. parkinson disease 3. on dopamine agonists (ropinirole ir or pramipexole ir) and are considering to change into ropinirole pr 4. on stable antiparkinsonian medication for at least 4 weeks 5. who signed consent to the study exclusion criteria: 1. who are on less than 2 mg of ropinirole ir or 0.375 mg of pramipexole ir 2. who have dementia, psychosis, major depression and other serious neurological or medical problems 3. who are allergic to the similar medications 4. who has history of heavy metal poisoning 5. who were on othe clinical trials of other medications within the last 4 weeks 6. whoa re pregnant or lactating 7. who are considered not eligible by the investigator

Keywords: parkinson disease ropinirole
open or keyhole surgery through the chest for newborn babies: effect on blood gases

Conditions: Esophageal Atresia With Tracheo-esophageal Fistula; Congenital Diaphragmatic Hernia

Summary: this is a pilot randomised controlled trial comparing open versus thoracoscopic surgery for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates. thoracoscopic surgery involves insufflation of carbon dioxide into the thoracic cavity and may therefore cause hypercapnia and acidosis.


Eligibility criteria:
inclusion criteria: * neonates with diagnosis of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia -\>1.6 kg * conventional ventilation (no high frequency ventilation or ino) for at least 24 hours. * fio2 \<0.4 * no requirement for inotropes for at least 24 hours exclusion criteria: * late diagnosis (after 1 month of age) * major congenital heart defects or pulmonary hypertension * bilateral grade iv intraventricular haemorrhage * previous ecmo * fio2 ≥ 0.4

Keywords: thoracoscopy congenital diaphragmatic hernia oesophageal atresia hypercapnia acidosis cerebral oxygenation neonates