Kornimate/medical-research-clean huggingface dataset:
respiratory function at preschool age of children detected of cystic fibrosis in neonatal period

Conditions: Cystic Fibrosis

Summary: the widespread neonatal detection of cystic fibrosis in france since 2002 permits to treat children from birth. new treatments used for young children involve to assess efficacy criteria specific to this population. standard respiratory function criteria for older children and adults is forced expiratory volume/second. this technique is not suited for preschool aged children (3 to 6 years old) because they are too old to be sedated and too young and immature to be able to make forced expiration technique that are correct, reproducible and prolonged during more than 1 second. for preschool aged children, in order to assess distal damage and her consequence, the evaluations are: airway resistance by debit interruption technic (rint), plethysmographic measure of specific resistance (sraw), functional residual capacity by helium dilution technique (crf he), arterial blood gas measurement, pulmonary clearance index. all these methods have a better success rate and can be used in alternative or with forced spirometry. however, each of them gives only a part of information on airway and lung damage of detected children. it is necessary to combine them for a better information on overall respiratory damage. in france, each respiratory function test laboratory uses one or any of these methods in addition to flow-volume curve, in function of his practices and his equipment. so, respiratory function test of preschool aged children is going to diversify more and more to the detriment of an homogeneity of practices between different centers. a referent population during a longitudinal multicenter monitoring on large cohorts that describe the evolution of pulmonary function, obtained by a standardized methodology is necessary to assess the efficacy of any new treatment. and, with the homogenization of care of children detected of cystic fibrosis in different centers, the description of natural evolution of pulmonary function by a standardized methodology will improve the discriminative power of measure of respiratory function to assess the presence of a worsening in preschool-aged children.


Eligibility criteria:
inclusion criteria: * patient suffering from cystic fibrosis * height between 90 et 130cm * no respiratory exacerbation since 4 weeks * benefit from an insurance disease regime exclusion criteria: * law-protected patient * patient's parent don't understand french language * opposition to participation

Keywords: time evolution of respiratory function longitudinal multicenter monitoring of large cohorts preschool aged children detection of cystic fibrosis in neonatal period
neural mechanisms of obsessive-compulsive disorder (ocd) treatment failure

Conditions: Obsessive-Compulsive Disorder

Summary: the aim of this study is to understand why patients with obsessive-compulsive disorder (ocd) fail in therapy. to understand the neural mechanisms involved in exposure therapy that support success and clinical improvement in order to improve therapy outcomes for ocd patients.

a course of therapy is recommended for individuals with obsessive-compulsive disorder (ocd). it is usually a type of cognitive behavioural therapy (cbt) with exposure and response prevention (erp). in this study the investigators assess patients pre-therapy and post-therapy evaluating symptom severity (measured by the y-bocs) and decision-making (measured by online questionnaires and computer-based behavioural tasks). to examine how decisions are formed in patients undergoing ocd cbt, how behaviour changes after a non-pharmacological therapy module and how it is associated to the alleviation of ocd symptoms. the study, which will recruit 90 patients, is based at university college london - wellcome centre for human neuroimaging. this study is a part of the cognitive and neural networks in psychiatry (cnnp) study.

Eligibility criteria:
inclusion criteria: * diagnosis of obsessive-compulsive disorder (ocd) * fluent in written and spoken english * normal/corrected to normal vision * expecting to start ocd therapy exclusion criteria: * autism spectrum disorder, psychosis, schizophrenia, addiction, substance abuse, bipolar, hoarding, or tourette disorder * hearing conditions: tinnitus, ear inflammation, hearing sensitivity, hearing loss, requires hearing aids * colour blindness * severe learning disabilities
comparison of pelvic floor therapy and yoga on stres urinary incontinence incontinence

Conditions: Urinary Incontinence; Urinary Tract Disorders

Summary: the aim of this study is to compare the effectiveness of pelvic floor physical therapy (pft) and therapeutic yoga training (tyt) for women who have postnatal stress urinary incontinence (sui).

32 subjects with postnatal stress urinary incontinence will be included in the study after a voluntary consent form will be filled out. subjects will randomly be divided into two groups according to the order. pelvic floor physical therapy (pft) (n=16) will be group 1, and therapeutic yoga training (tyt) (n=16) will be the group 2. pft group will be received sessions twice a week and a special home exercise program once a week for 8 weeks. each session will include warm-up exercises, pelvic floor muscle contractions in different positions, and abdominal breathing techniques. each session is planned for 45 minutes. tyt group will be received sessions twice a week and a special home exercise program once a week for 8 weeks. each session will include warm-up exercises, different asanas, and yogi breathing exercises. each session is planned for 45 minutes.

Eligibility criteria:
inclusion criteria: * women ages between 18 and 50 years old, * women who have sui 45 days and above after giving birth * patients who accept to join the group sessions and will participate regularly in the treatment program exclusion criteria: * women who have pelvic organ prolapsus and fecal incontinence * women who have undergone surgery for the lower urinary system * those who receive medication treatment for incontinence in the last 3 months * those with acute infection and bladder stones or tumors will not be included in the study.

Keywords: urinary incontinence postnatal yoga pelvic floor muscle rehabilitation quality of life
japanese pradaxa pms, long term

Conditions: Atrial Fibrillation

Summary: the study objective is to confirm appropriate use and safety profile of prazaxa® capsules in real-world setting after the availability of idarucizumab

the study is post-marketing surveillance on the long-term use of prazaxa® capsules in japanese patients with nonvalvular atrial fibrillation after the availability of idarucizumab. even after the availability of idarucizumab in real clinical practice, appropriate use of prazaxa® capsules will continue. the patient population who receive prazaxa® capsules and the safety profile of prazaxa® capsules is not expected to change. this study investigates appropriate use with prospective investigation in the routine medical practice

Eligibility criteria:
inclusion criteria: * male and female patients with nonvalvular atrial fibrillation who have never received prazaxa® capsules / dabigatran etexilate for preventing the occurrence of ischemic stroke and systemic embolism before enrolment in japan exclusion criteria: * none
effectiveness of app-based relaxation for patients with chronic low back pain (relaxback)

Conditions: Chronic Low Back Pain

Summary: the aim of the pragmatic randomized study is to evaluate whether additional relaxation technique is more effective in the reduction of chronic low back pain compared to usual care alone.

objective: to evaluate whether additional relaxation technique is more effective in the reduction of chronic low back pain compared to usual care alone. study design: open single-centered randomized two-armed pragmatic trial. participants: 220 patients aged 18-65 years with chronic (\>12 weeks) low back pain and a mean pain score ≥ 4 on a numeric rating scale (nrs) in the last week before randomization who will be randomly allocated to two groups (relaxation, usual care alone as waiting list) intervention: participants apply either a daily 15-minute relaxation exercise guided by a smartphone application ("app"). or apply no additional intervention. the exercise should be applied daily, (minimally five days per week) for 6 months. the app contains audios to guide autogenic training, muscle relaxation training and guided imagery. on a daily basis, participants can select one of the three exercises which they want to apply. main outcome measure: the primary outcome is the mean pain intensity after 3 months measured by the daily pain intensity on the nrs.

Eligibility criteria:
inclusion criteria: * female or male * 18-65 years of age * chronic low back pain for at least 12 weeks * if additional back pain is reported, low back pain has to be predominant * intensity of the average low back pain ≥ 4 on the numeric rating scale (nrs) in the last week * presence of a smartphone (iphone, android phone) and willingness to do data entry through a smart phone application (app) * willingness to be randomized, to apply study intervention according to the protocol, to complete the baseline questionnaire in paper form and electronic questionnaires and diaries provided by an app physical and mental ability to participate in the study * written and oral informed consent exclusion criteria: * low back pain caused by a known malignant disease * neck pain caused by trauma * known rheumatic disorder * history or planned surgery of the spinal column of the low back in the next 6 months * known neurological symptoms e.g radicular symptoms because of prolapsed vertebral disc * regular intake of analgesics (\>1x per week) because of additional diseases * intake of centrally acting analgesics * known severe acute or chronic disorder, that do not allow participation in the therapy * other known diseases, that do not allow participation in the therapy * known alcohol or substance abuse * no sufficient german language skills * current application for a benefit * participation in another clinical trial during six months before the study and parallel to the study * conducting regular relaxation techniques, mindfulness training or meditation six weeks before the study or planned in the next 6 months

Keywords: low back pain relaxation
effect of oral combined berberine and curcumin pharmacological therapy on ibs

Conditions: Irritable Bowel Syndrome

Summary: irritable bowel syndrome (ibs) is a prevalent, chronic functional gastrointestinal (gi) disorder, characterized by recurrent abdominal discomfort (pain) associated with altered bowel movements. ibs has a considerable negative impact on people's quality of life (qol). there is currently no specific treatment available for ibs; most of the therapeutic management is symptomatic. reported evidence suggest that bbr and cur can alleviate symptoms of ibs through their multiple pharmacological effects including preventing stress-induced intestinal inflammation and visceral hypersensitivity, reducing bowel motility, and regulating intestinal permeability, gut microme and gut-brain axis.

aim of the study: the present clinical study aimed to assess the synergestic therapeutic effect of a combined supplement of standardised extract of bbr and cur (enterophytol® plus, 200 mg bbr, 49 mg cur) in the management of ibs. method : this was an in real-life setting pragmatic, observational, retrospective, non-controlled and non-randomized clinical trial involving 146 patients with ibs, enrolled in general practitioner clinics and pharmacies in belgium from aug 2020 to may 2022. the supplement was used as two tablets daily for 2-months, alongside routine ibs care.

Eligibility criteria:
inclusion criteria: * self-completion of simplified form of the rome iv ibs diagnostic criteria * had ibs symptoms that appeared before the age of 50 * used enterophytol® plus as complementary therapy as two tablets a day for 2-months exclusion criteria: * those with involuntary weight loss * family history of chronic inflammatory bowel disease, colorectal cancer, celiac disease, rectal discharge, nocturnal symptoms, fever, and abnormalities on clinical examination (abdominal mass, signs of anaemia).
a comparison of prasugrel and clopidogrel in acute coronary syndrome subjects

Conditions: Acute Coronary Syndrome

Summary: this study will evaluate the relative efficacy and safety of prasugrel and clopidogrel in a medically managed unstable angina/non-st-elevation myocardial infarction (ua/nstemi) acute coronary syndrome (acs) population (that is, patients who are not managed with acute coronary revascularization).

based upon the significant number of subjects with ua/nstemi acs who are managed medically and their high risk for future cardiovascular events, further exploration of novel treatment strategies for this population, who are under-represented in large clinical trials, is warranted. potential subjects will be those with a recent ua/nstemi event who are to be medically managed. eligibility for this study will be determined by both the timing of the medical management decision and by prior commercial clopidogrel treatment at the time of randomization. the targeted platelet inhibition to clarify the optimal strategy to medically manage acute coronary syndromes (trilogy acs) study will assess the efficacy and safety of prasugrel and aspirin compared to the current standard of care, clopidogrel and aspirin, for long-term treatment of medically managed ua/nstemi acs subjects.

Eligibility criteria:
key inclusion criteria: * have had a unstable angina/non-st-elevation myocardial infarction (ua/nstemi) index event within 10 days prior to randomization * had a medical management strategy decision made with reasonable certainty that neither percutaneous coronary intervention (pci) nor coronary artery bypass graft (cabg) is planned for treatment of the index event * had at least 1 of 4 specified high-risk features at the time of the ua/nstemi event key exclusion criteria: * decision for medical management greater than 72 hours after onset of index event without commercial clopidogrel treatment within 72 hours following onset of the index event. * insignificant coronary artery disease (cad) on coronary angiography if performed for index event (absence of greater than or equal to 30% stenosis in at least one native vessel) * previous or planned pci or cabg as treatment for the index event * pci/cabg within previous 30 days * st-segment elevation myocardial infarction (stemi) as the index event * cardiogenic shock, refractory ventricular arrhythmias, new york heart association (nyha) class iv congestive heart failure (chf) within the previous 24 hours * history of ischemic or hemorrhagic stroke, transient ischemic attack (tia), intracranial neoplasm, arteriovenous malformation, or aneurysm * history of spontaneous gastrointestinal (gi) or non-gi bleeding requiring hospitalization for treatment, unless definitive treatment has occurred and there is low likelihood of recurrence * hemodialysis or peritoneal dialysis

Keywords: acs
tace combined surgery for the resectable huge hcc

Conditions: Hepatocellular Carcinoma; Hepatic Chemotherapy; Liver Cancer; Surgery

Summary: huge hepatocellular carcinoma (hcc) is defined as a tumor with a maximum diameter greater than 10 cm. with advancements in surgical techniques, hepatectomy can be performed safely in some patients with huge hcc without vascular invasion or distant metastasis and with preserved liver function. the high risk of recurrence after surgery is another challenge for surgeons. neoadjuvant tace has been shown to improve the clinical outcomes of patients with hcc, especially those with a high risk of recurrence, such as those with multinodular tumors, large tumors, and tumor thrombus. the present multicenter study aimed to evaluate the efficacy of neoadjuvant tace in patients with huge hcc who underwent liver resection.

huge hepatocellular carcinoma (hcc) is defined as a tumor with a maximum diameter greater than 10 cm. with advancements in surgical techniques, hepatectomy can be performed safely in some patients with huge hcc without vascular invasion or distant metastasis and with preserved liver function. however, the 2-year recurrence rate in such cases is as high as 70%, indicating the need for more effective interventions to improve outcomes. neoadjuvant tace has been shown to improve the clinical outcomes of patients with hcc, especially those with a high risk of recurrence, such as those with multinodular tumors, large tumors, and tumor thrombus. the impact of neoadjuvant tace on the long-term oncological outcomes of huge hcc requires investigation. the present multicenter study aimed to evaluate the efficacy of neoadjuvant tace in patients with huge hcc who underwent liver resection.

Eligibility criteria:
inclusion criteria: 1. clinical or pathological diagnosis of primary hcc; 2. tumor diameter \> 10 cm on images before inclusion; 3. age 18 to 75 years; 4. no macrovascular invasion or extrahepatic metastasis; 5. liver resection with complete removal of the tumor and adequate remnant liver volume; 6. albumin-bilirubin (albi) grade i and ii; 7. eastern cooperative oncology group performance status (ecog) score of 0-1; 8. hemoglobin level ≥ 8.5 g/dl, total bilirubin level ≤ 30 mmol/l, alanine transaminase (alt) and aspartate aminotransferase (ast) levels ≤ 5 × upper limit of normal, serum creatinine level ≤ 1.5 × upper limit of normal; 9. prothrombin time ≤ 18 s or international normalized ratio \< 1.7. exclusion criteria: 1. hcc with macrovascular invasion or extrahepatic metastasis; 2. tumor with a maximum diameter ≤ 10 cm on images before inclusion; 3. recurrent hcc; 4. serious medical comorbidities; 5. portal hypertension, including presence of either esophageal varices or splenomegaly with a platelet count less than 109/l; 6. cardiac ventricular arrhythmias requiring anti-arrhythmic therapy; 7. incomplete data or lost to follow-up within three months.

Keywords: huge hepatocellular carcinoma tace surgery
prospective registry of immediate/delayed loading of implants in the cranial bone-grafted severely atrophic jaw

Conditions: Jaw, Edentulous; Jaw, Partially Edentulous

Summary: edentulism is often associated with a negative psychosocial impact. the concept of prosthetic rehabilitation in which a prosthesis is supported by osseointegrated implants, was first introduced in the late 1960s by brånemark et al. and offers an interesting alternative to removable prosthesis. however, for patients with a severely atrophic maxilla or mandible, cranial bone grafting of the jaw is required to increase bone width and height necessary for implant insertion. an active collaboration between the surgeons from the oral and maxillofacial department and the prosthodontist from the department of dentistry has been established for continuous quality improvement of the concept of (immediate/delayed) implant loading in patients requiring cranial bone grafts to augment their severely atrophic jawbone. the investigators aim to develop a prospective database registering (immediate/delayed) implant loading data of all patients eligible according to the protocol. patient demographics, surgical, dental, prosthetic and patient satisfaction parameters are collected during consecutive visits within the framework of routine practice. development of a database registering immediate functional loading data secondary to cranial bone-grafting of a severely atrophic jaw, will provide more information about potential patient, surgical and prosthetic factors influencing long-term biological and mechanical stability, as well as patient satisfaction. moreover, registration of those results could function as a measurement of quality of care, and could be used for sample size calculation for future large prospective trials.


Eligibility criteria:
inclusion criteria: * patients of all ages * patients of all genders * patients with moderate to extreme bone atrophy of the jaw (class iv to vi according to cawood and howell (cawood \& howell, 1988), caused by terminal periodontitis or edentulism * patients requiring bone augmentation procedures through cranial bone grafting for jaw reconstruction * patients ineligible for conventional removable prosthetic rehabilitation exclusion criteria: * patients not eligible according to abovementioned criteria * patients with severe uncontrolled diabetes * patients with cranial vault without diploe and/or cranial vault thickness \<3mm, as defined with cone-beam ct (de ceulaer, et al., 2012)

Keywords: severely atrophic jaw cranial bone-graft dental implants immediate loading augmentation maxilla/mandible sinus-floor elevation/sinuslift dental prosthesis implant supported provisional implants temporary implants one-stage surgery alveolar ridge augmentation maxilla
prevention of relapse study of sr58611a in improved patients with generalized anxiety disorder

Conditions: Anxiety Disorders

Summary: the purpose of the study is to evaluate the efficacy and safety of sr58611a (350 mg bid) compared to placebo in the prevention of relapse of anxiety, in patients with generalized anxiety disorder improved after 12 weeks of treatment with sr58611a. the primary objective is to evaluate the efficacy of sr58611a 350mg bid compared to placebo over a 24 to 52-week treatment period. the secondary objective is to assess the safety and tolerability of sr58611a in patients with gad.


Eligibility criteria:
inclusion criteria: for entry into the open phase: * patients suffering from generalized anxiety disorder, according to diagnostic and statistical manual of mental disorders (dsm-iv-tr) criteria and assessed with the mini international neuropsychiatric interview (mini) plus generalized anxiety disorder (gad) module. * with a total score on the 14-item hamilton anxiety rating scale (ham-a) \> 20 at v1(d-4) and v2 (d-1). for entry into the double-blind randomized phase: * improved patients with ham-a score \< 11 at v7 (w12). exclusion criteria: * inpatients. * patients with a diagnosis of major depressive disorder (dsm iv-tr) within 6 months of screening. * patients with a madrs total score \> 18 at screening or baseline. * patients at immediate risk for suicidal behaviour. * patients with other current (within 6 months) anxiety disorder according to the mini * patients with a lifetime history according to the mini of: bipolar disorder, psychotic disorder, antisocial personality disorder. * patients with a current history according to the mini of: anorexia nervosa or bulimia nervosa in the past 6 months, alcohol or substance dependence or abuse in the past 12 months, except nicotine or caffeine dependence. the investigator will evaluate whether there are other reasons why a patient may not participate.

Keywords: anxiety disorders, relapse prevention
the accuracy of swallowing disturbance questionnaire in screening inpatient elderly

Conditions: Deglutition Disorders

Summary: the aim of this research was to examine the accuracy of translated chinese version of swallowing dysphagia questionnaire and to evaluate the prevalence of dysphagia and its clinical manifestation in patients over 65 years old.


Eligibility criteria:
inclusion criteria: * (1) age over 65 years old; (2) does not use enteral tube feeding; (3) no serious mental or cognitive conditions; no aphasia exclusion criteria: * (1) age under 65; (2) use enteral tube feeding; (3) subjects with serious mental or cognitive conditions or aphasia (4) allergy to barium sulfate suspension

Keywords: elderly screening