Kornimate/medical-research-clean huggingface dataset:
exploration of the pleural cavity using a flexible endoscope

Conditions: Pleural Effusion

Summary: explore is a first-in-human study of single port transdiaphragmatic thoracoscopy using a flexible gastro-intestinal endoscope under two-lung ventilation with controlled capnothorax.

thoracoscopy is usually performed either with rigid thoracoscopes, or with flexible bronchoscopes. the latter is less invasive and less expensive, but flexible bronchoscopes are difficult to manipulate within the pleural cavity and do not provide an adequate orientation within the pleural space. it is therefore associated with a lower diagnostic yield than thoracoscopy with rigid thoracoscopes. on the other hand, rigid thoracoscopes are associated with more pain, a higher cost, and usually require one-lung ventilation. gastro-intestinal endoscopes allow a better orientation than bronchoscopes in cavities, and have wider operative channels. the explore study investigates the feasibility and safety of single port transdiaphragmatic thoracoscopy using a flexible gastro-intestinal endoscope under two-lung ventilation with controlled capnothorax.

Eligibility criteria:
inclusion criteria: * diagnosis of pleural effusion affirmed by chest radiography, * indication thoracoscopy, asked by the pulmonologist or thoracic surgeon for diagnostic investigation and / or pleural symphysis * inpatient or outpatient, * women of childbearing age having an effective contraceptive coverage (combined oral contraceptives or intrauterine device or tubal ligation); a negative pregnancy test should be obtained, * for postmenopausal women, menopause confirmation of diagnosis, exclusion criteria: * pleural effusion compression, * pleural effusion infected or suspected of infection, * febrile patient (\> 38 ° c) * parapneumonic effusion * immunosuppression (eg, neutropenia \<1g / l, immunosuppressive therapy, ...) * portage known multidrug-resistant germ or s. aureus resistant to methicillin, * clinical suspicion of tuberculosis, * patients who have already been treated by pleurodesis, * contraindication to general anesthesia, * contraindication of prophylactic antibiotics, * contraindication to pleurodesis agent * increased bleeding risk, * no one deprived of liberty by an administrative or judicial decision or protected adult subject (under guardianship) * pregnant or breastfeeding women.

Keywords: flexible endoscopy
visual performance of prototype contact lens designs

Conditions: Presbyopia; Refractive Error

Summary: the aim of this study is to assess the visual performance of prototype soft contact lens designs compared to a commercially available contact lens

prospective, participant-masked, randomised, stratified, crossover, bilateral wear, dispensing clinical trial where participants will wear the prototype (test) and the commercial (control) lens. a minimum of an overnight washout period is required between the fitting /assessment visits.

Eligibility criteria:
inclusion criteria: * able to read and comprehend english and give informed consent as demonstrated by signing a record of informed consent. * be at least 7 years old, male or female. * willing to comply with the wearing and clinical trial visit schedule as directed by the investigator. * have ocular health findings considered to be "normal" and which would not prevent the participant from safely wearing contact lenses. * correctable to at least 6/12 (20/40) or better with both eyes with contact lenses. * be suitable and willing to wear contact lenses. exclusion criteria: * any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses. * any systemic disease that adversely affects ocular health e.g. diabetes, graves' disease, and auto immune diseases such as ankylosing spondylitis, multiple sclerosis, sjögrens syndrome and systemic lupus erythematosus. conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants. * use of or a need for concurrent category s3 and above ocular medication at enrolment and/or during the clinical trial. * use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant's ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and/or during the clinical trial. * eye surgery within 12 weeks immediately prior to enrolment for this trial. nb: systemic antihistamines are allowed on an "as needed basis", provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used.

Keywords: presbyopia refractive error correction contact lenses
viral epidemiology of bronchiolitis after nirsevimab implementation and respiratory evolution in infants

Conditions: Acute Bronchiolitis

Summary: acute bronchiolitis in infants, mainly caused by the respiratory syncytial virus (rsv), is a public health issue, in terms of morbidity and hospital costs. nirsevimab, a long-acting antibody against rsv available for all infants under 12 months, could profoundly modify the epidemiology of the next epidemic seasons, with the increase of the frequency of the other respiratory viruses (endemic coronaviruses, metapneumovirus, etc) monitoring viral ecology is important, as the impact of respiratory infections on morbidity in the short, medium and long term, but also in economic terms. infants under the age 12 months with a first episode of bronchiolitis and consulting the emergency pediatric department will be included. a nasopharyngeal swab will be performed as routine care, and clinical data will be collected. multiplex polymerase chain reaction will be performed to identify respiratory virus(es) responsible for the bronchiolitis. in hospitalized infants with rsv or rhinovirus positive polymerase chain reaction (pcr), daily nasal washes will be collected to perform viral loads with specific quantitative pcr (nasal washes biobank), associated with daily clinical data. a 12-month follow-up is planned for every infant included, consisting with 4 phone calls, to identify factors associated with the onset of preschool wheezing. the main objective is to describe the viral epidemiology associated with acute bronchiolitis leading to a pediatric emergency department visit the implementation of nirsevimab.


Eligibility criteria:
inclusion criteria: * infant aged 12 months or less * admitted to the pediatric emergencies services during one of the three epidemic years: 2024-2025, 2025-2026 and 2026-2027 * with clinical diagnosis of first episode of acute bronchiolitis by the emergency pediatrician * with nasopharyngeal swab for virological diagnosis exclusion criteria: * refusal of one or more of the infants parents to participate in the study * infants parents refused to be called back for follow-up * no nasopharyngeal swab taken

Keywords: nirsevimab passive immunization pediatric emergencies viral epidemiology acute bronchilitis
hot water immersion after myocardial infarction

Conditions: Cardiac Disease; Cardiac Rehabilitation

Summary: myocardial infarction (mi) is a leading cause of death in developed countries, including sweden. standard treatment for patients after mi includes exercise-based cardiac rehabilitation which contributes to improved cardiovascular function and reduces the risk of hospital readmissions, new cardiovascular events and mortality. thermotherapy may also have beneficial effects on cardiovascular disease by a reduction in inflammatory status and improved metabolism and vascular function. given the well-documented effects of exercise training on cardiac rehabilitation and recent evidence that thermotherapy may improve cardiovascular function, we wish to investigate the effect of exercise combined with hot water immersion (hwi) in cardiac rehabilitation post-mi. this is a single-centre, randomized controlled clinical trial in patients with recent mi. our aim is to investigate whether exercise training combined with hwi improves inflammatory and metabolic status, cardiovascular function as well as psychological well-being, compared with exercise training alone. patients will be randomized 1:1 to an 8 week intervention with exercise training 2 times per week followed by 15 minutes of hot water immersion, or to a control group with exercise training alone. the primary endpoint is changes in the inflammatory marker interleukin (il-) 6 between groups at 8 weeks. secondary endpoints include other biomarkers of inflammation, metabolism, effects on cardiovascular function and psychological benefits. secondary prevention after mi has improved during the last decades but readmissions and death following acute mi remain large health challenges. if hwi in addition to standard cardiac rehabilitation can lower inflammation more than standard therapy alone, and improve metabolic, cardiovascular and psychological status, it could be a cost-effective and safe complementary strategy for secondary prevention after mi, particularly for those with limited exercise capability.


Eligibility criteria:
inclusion criteria * patients with a diagnosis of st-elevation myocardial infarction (stemi) or non-stemi * concomitant participation in standard care exercise-based cardiac rehabilitation * male or female patients ≥ 18 years * written informed consent exclusion criteria * regularly performing hot water immersion, sauna or other types of thermotherapy * not willing to perform hot water immersion regularly * febrile illness or acute, ongoing infection * \<18 years of age * inability to provide informed consent
efficacy and safety of alirocumab (sar236553/regn727) versus placebo on top of lipid-modifying therapy in patients with heterozygous familial hypercholesterolemia (odyssey high fh)

Conditions: Hypercholesterolaemia

Summary: alirocumab (sar236553/regn727) is a fully human monoclonal antibody that binds pcsk9 (proprotein convertase subtilisin/kexin type 9). primary objective of the study: to evaluate the effect of alirocumab on low-density lipoprotein cholesterol (ldl-c) levels after 24 weeks of treatment in comparison with placebo. secondary objectives: * to evaluate the effect of alirocumab in comparison with placebo on ldl-c at other time points * to evaluate the effects of alirocumab on other lipid parameters * to evaluate the safety and tolerability of alirocumab

the maximum study duration was planned to be 89 weeks per participant including participants who successfully completed the 78-week treatment period had the possibility to join an open-label extension study (lts13463, nct01954394) at the end of the treatment period.

Eligibility criteria:
inclusion criteria: * participants with heterozygous familial hypercholesterolemia who were not adequately controlled with their lipid-modifying therapy. exclusion criteria: * age \< 18 years * ldl-c \< 160 mg/dl (\< 4.14 mmol/l) at the screening visit (week-3). * fasting serum triglycerides \> 400 mg/dl (\> 4.52 mmol/l) during the screening period. * known history of homozygous familial hypercholesterolemia. the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
analgesic efficacy of intravenous ibuprofen in biliary colic

Conditions: Biliary Colic

Summary: the aim of this study is to assess the analgesic efficacy of intravenous ibuprofen given in the emergency department for the treatment of biliary colic. we hypothesize that intravenous ibuprofen will provide a clinically significant drop in self-reported patient pain level as measured by the visual analog scale.

it is estimated over 20 million people aged 20-74 have gallbladder disease, with biliary colic being a common and painful symptom in these patients. likely due to the relatively recent approval of intravenous ibuprofen use for fever and pain in adults, no assessment of its analgesic efficacy for biliary colic currently exists in the literature. utilizing a visual analog scale (vas) for patient self-assessment of pain, this study will address this lack of evidence and identify intravenous ibuprofen's value as a novel analgesic in the treatment of biliary colic. patients will be given a vas at the time of study therapy administration, at 15-minute intervals during the first hour post-administration, and 30-minute intervals in the second hour. though nsaid's have been extensively studied in the management of this phenomenon, this study aims to help optimize pain treatment of patients presenting to the emergency department with biliary colic, and potentially pave the way for future analgesic treatment comparison studies.

Eligibility criteria:
inclusion criteria: * patients ages 18-55 * present to ed with right upper quadrant (ruq) abdominal pain * suspected diagnosis of biliary colic * negative pregnancy test for women of childbearing potential (complete poc testing form) * no history of cholecystectomy exclusion criteria: * patient age \ 55 * incarcerated * hemodynamic instability * inability to reliably self-report or communicate pain intensity and pain relief * taking warfarin * cannot consent of are not competent to consent * hepatic, renal, cardiac failure * nsaid or morphine allergy * history congenital bleeding diathesis or platelet dysfunction * peptic ulcer diseases * are otherwise unsuitable for the study in the opinion of the investigator/sub-investigators

Keywords: biliary colic abdominal pain intravenous ibuprofen
immunogenicity of dtap-ipv-hep b-prp~t combined vaccine compared with pentaxim™ and engerix b® at 2-3-4 months schedule

Conditions: Hepatitis B; Polio; Diphtheria; Pertussis

Summary: to demonstrate that the immune response to hepatitis b antigen of the dtap-ipv-hep b-prp\~t is non-inferior to that of the association of pentaxim™ and engerix b® one month after a three dose (2-3-4 month) primary series. immunogenicity * to assess pre- and post-primary series * to assess pre- and post-booster series.


Eligibility criteria:
inclusion criteria: * two-month old infants of either gender on the day of inclusion * born at full term of pregnancy (\>=37 weeks) with a birth weight \>=2.5 kg * informed consent form signed by the parent(s) or other legal representative(s) and an institution official other than an investigator * able to attend all scheduled visits and to comply with all trial procedures. exclusion criteria: * participation in another clinical trial in the 4 weeks preceding the first trial vaccination * planned participation in another clinical trial during the present trial period * congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid therapy * systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to a vaccine containing the same substances * chronic illness at a stage that could interfere with trial conduct or completion * blood or blood-derived products received since birth * any vaccination (except bcg) in the 4 weeks preceding the first trial vaccination * vaccination planned in the 4 weeks following trial vaccination * history of documented pertussis, tetanus, diphtheria, polio, haemophilus influenzae type b or hepatitis b infection(s) (confirmed either clinically, serologically or microbiologically) * known personal or maternal history of hiv, hepatitis b or hepatitis c seropositivity * previous vaccination against pertussis, tetanus, diphtheria, polio or hib, and hb infection(s) * coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination * history of seizures * febrile (axillary temperature 37.4°c \[rectal equivalent temperature \>=38.0°c\]) or acute illness on the day of inclusion.

Keywords: hepatitis b polio diphtheria pertussis h influenzae type b
the effectiveness of mindfulness based cognitive group therapy for social anxiety symptoms in people living with alopecia areata

Conditions: Alopecia Areata; Social Anxiety

Summary: this study investigates the impact of mindfulness based cognitive therapy (mbct) on social anxiety in adults with alopecia areata. a single-group case-series design will be adopted.

alopecia areata (aa) is an immunological disorder which is characterised by round/oval patches of non-scarring hair loss. people living with aa are at higher risk of developing depression, anxiety and social phobia than the general population (koo et al., 1994; ruiz-doblado, carrizosa, \& garcía-hernández, 2003). interventions that aim to reduce engagement in negative appearance related thoughts, and attentional bias towards negative self-referential information may be helpful for this population. mindfulness-based cognitive therapy (mbct) offers one potential method of reducing social anxiety in individuals with aa. mbc is a structured eight-week programme that has been recommended by the national institute of clinical excellence as an effective intervention to reduce the risk of relapse in depression since 2009. the main aim of the current study is to investigate whether an mbct course can reduce social anxiety in individuals with aa. a single-group case-series design will be adopted, whereby participants will act as their own control; data collected from participants during and after they have received the intervention will be compared to data collected before they have received the intervention. semi-structured interviews will be carried out at the end of the study to investigate participants experiences of the intervention. the investigators predict that mbct will reduce social anxiety in individuals with aa. more specifically, the hypothesis are: (i) participants will experience an increase in mindfulness during the intervention period, relative to the baseline phase and this will be maintained at follow-up (ii) increases in mindfulness will be associated with decreases in social anxiety, anxiety and depression, and increases in dermatology quality of life.

Eligibility criteria:
inclusion criteria: * aa is the main presenting physical health problem * participant self-identifies as experiencing social anxiety * sufficient english to participate in group sessions and discussion. * aged 16 and over exclusion criteria: * primary psychiatric diagnosis affecting skin (e.g., trichotillomania) * hair loss as a result of medical intervention or surgery (e.g., chemotherapy) * the skin condition is secondary to other physical health problems (e.g., arthritis, cancer, chronic pain) * patient does not report any social distress as a result of their aa * currently undergoing other psychological therapy
a trial of bedside placement of nasal jejunal tube confirmed by ultrasound compared to placement by endoscope in patients with sap

Conditions: Bedside Placement of Nasal Jejunal Tube

Summary: the investigators assessed the utility of ultrasonography in confirming the position of nasal jejunal tube after bedside placement when compared with endoscopic placement in patients with severe acute pancreatitis. primary endpoint: success rate. secondary endpoint: adverse effects, change of intra-abdominal pressure (1h before, 1h after and 3 days after placement), tolerance of enteral nutrition, time to approach the target calories.

we set this randomised trial to assess the safety and utility of ultrasonography in confirming the position of nasal jejunal tube after bedside placement when compared with endoscopic placement in patients with severe acute pancreatitis. primary endpoint: success rate. secondary endpoint: adverse effects, change of intra-abdominal pressure (1h before, 1h after and 3 days after placement), tolerance of enteral nutrition, time to approach the target calories.

Eligibility criteria:
inclusion criteria: * acute pancreatitis patients who need enteral nutrition; * patients in acute phase of pancreatitis (within 2 weeks from onset); * the severity of pancreatitis is equal to or above moderate (according to the revised classification of pancreatitis). exclusion criteria: * diagnosed with iah(intra-abdominal pressure) iv grade, abdominal compartment syndrome (acs); * patients who have circulatory failure; * patients who have gastrointestinal bleeding; * patients who have specific diseases such as chronic digestive diseases and autoimmune diseases; * patients in pregnancy.

Keywords: bedside placement nasal jejunal tube ultrasound severe acute pancreatitis endoscope efficacy safety
analysis of chilblains profile during covid-19 epidemic (acrovid)

Conditions: COVID-19; Chilblains

Summary: cases of chilblains have been reported with an unusual frequency in france in the context of the coronavirus infectious disease 2019 (covid-19) epidemic. some of these cases have been linked to a virological status in favour of a recent severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection. chilblains are acral inflammatory lesion typically reactive to cold (primary form). there are secondary forms acquired during autoimmune connectivitis such as lupus chilblain or hereditary forms related to type i interferonopathy. an interferon type i signature has been described in these secondary forms of frostbite but also during the cytokine storm of severe forms of cov-2 sars infection. if cases of frostbite are indeed secondary to an sars-cov-2 infection, comparative analysis of their immunopathological profiles could provide a better understanding of the inflammatory mechanisms during covid-19.


Eligibility criteria:
inclusion criteria: * patient over the age of majority or a minor over 12 years of age accompanied by his/her legal representative * benefiting from a social security scheme * informed consent signed by the patient (if major) or by his legal representative (if minor) after clear, fair and appropriate information about the study. * red and swollen lesions of the hands and/or feet evolving for more than 24 hours in the context of a covid-19 epidemic. * pcr sars-cov-2 pcr on nasopharyngeal swab with results available, prior to the inclusion visit. * absence of fever or respiratory signs suggestive of covid-19 for at least 14 days exclusion criteria: * a person who does not benefit from a social security scheme or who does not benefit from it through a third party. * patient who is subject to a judicial safeguard measure * allergy to local anaesthetic products * fever or respiratory signs suggestive of covid-19 within 14 days
fluorescent thoracoscopy used in surgery for palmar hyperhidrosis

Conditions: Palmar Hyperhidrosis

Summary: t3/t4 endoscopic thoracic sympathicotomy is a widely accepted and effective treatment for primary palmar hyperhidrosis. however, sympathetic ganglions are invisible with traditional thoracoscopy and until now, the location of ganglions are confirmed by rib indirectly. the team from thoracic department of peking university people's hospital discovered that the sympathetic ganglions can be visualized with fluorescent thoracoscopy. thus, investigators want to apply fluorescent thoracoscopy in sympathicotomy of palmar hyperhidrosis, to conduct a more precise operation and compare the efficiency of the novel and traditional methods.


Eligibility criteria:
inclusion criteria: 1. diagnosed with primary palmar hyperhydrosis. 2. accept surgical treatment and signed informed consent. exclusion criteria: 1. liver dysfunction. 2. allergic to indocyanine green. 3. can't tolerate thoracoscopic surgery.