Kornimate/medical-research-clean huggingface dataset:
clinical study to evaluate the ibs symptoms improving effect and safety of gtb1

Conditions: Irritable Bowel Syndrome With Diarrhea

Summary: this study was conducted to investigate the effects of daily supplementation of l. plantarum apsulloc 331261(gtb1tm) on improvement of ibs symptoms.


Eligibility criteria:
inclusion criteria: * male and female subjects older than 19 years old * diagnosed case of ibs using rome iv criteria * who had type 6 or 7 stools according to the bsfs on at least 2 weeks ≥ 25% * who voluntarily agreed to participate in the study and signed an informed consent form exclusion criteria: * who had been ingesting products containing probiotics or prebiotics in the 4 weeks preceding entry into the trial * who had antibiotic agents during the 4 weeks prior to study entry * women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives * who is determined ineligible for study participation by investigators for any other reasons
ethanol gel versus steroid in refractory lumbar discogenic pain

Conditions: Lumbar Discogenic Pain (Disorder)

Summary: discogel® is on the market since 2007. about 20,000 kits were sold to date (october 2017). the device re-obtained its ce mark in 2017. a clinical evaluation was performed by bibliographic route in 2016. clinical data on more than 600 patients treated by discogel® were analyzed. these data should be confirmed by monitoring on the long term, with a large cohort of patients, over a two-year follow-up period. as part of the post-ce surveillance, the manufacturer gelscom is responsible of this "post-market clinical follow-up" (pmcf) study in accordance with directive 93/42/eec and meddev guide 2.12/2, to assess the efficacy and the long-term safety of discogel®. the study is comparative. the results will evaluate the performance and safety of the ce-marked medical device used in "real life", in comparison with a steroid infiltration, used according to its indication and to the current standards. it will include economic data. patients and evaluators will be blinded. both discogel® and hydrocortancyl 2,5 pour cent are authorized products used according to their intended use. this is an interventional, prospective, national, multi-center, comparative, randomized, single-blind (patient and evaluator) post-market clinical study. the primary objective is to compare the short-term efficacy profile of discogel® versus intradiscal steroid.


Eligibility criteria:
inclusion criteria: * patient 18 years of age or older; * 2-month refractory pain to conservative treatment, non-surgical patients; * chronic discogenic pain (1 or 2 lumbar discs) with concordant mr imaging; * symptomatic for at least 8 weeks despite appropriate medical treatment; * patient who agrees to participate in the study and who signed the informed consent form; * patient with social protection. exclusion criteria: * previous surgical treatment of the studied disc(s); * patient with pure radicular pain; * sick leave of more than 12 months secondary to the symptoms; * patients who cannot read or write french; * history of cognitive-behavioral disorders that could interact with assessment by self-questionnaire; * local or general infection, or suspicion of infection; * severe coagulation disorders; * other rheumatic inflammatory disease; * undercurrent serious pathology with life expectancy \< 2 years; * female of childbearing age that are known to be pregnant during inclusion visit or wishing to become pregnant before treatment; * subject who has forfeited their freedom by administrative or legal award, or is under guardianship or under limited judicial protection * patient participating in another interventional clinical trial or testing an experimental drug within 30 days of inclusion in the study.
occupational insertion and educational level of adult patients with pediatric early inflammatory bowel disease (ibd)

Conditions: Crohn Disease; Ulcerative Colitis

Summary: the main objective of this project is to assess the occupational insertion of these adult patients with pediatric-onset ibd and to compare it with the general population. the secondary objectives are: 1. to assess the level of education and compare it to that of the general population 2. to assess occupational insertion and the educational level according to: * the disease (crohn's disease, ulcerative colitis or unclassified colitis) * sex * age at diagnosis (\<or ≥ 10 years) * the occurence of surgery, the location of the disease, the treatments undertaken * quality of life 3. evaluate the patient's feelings about the impact of his illness on occupational insertion and the educational level 4. to describe the quality of life of patients in relation to disease activity and health states (qaly calculation) 5. to assess the responsivness to change of the functional handicap score ibd-di (n = 200 patients)

chronic inflammatory bowel diseases (ibd) are responsible for high morbidity and impaired quality of life of patients throughout disease course. numerous studies have shown the impact of the disease on the quality of life of patients with ibd. however, very little data is available on the level of education and professional integration of patients who started their ibd in childhood. the hypothesis behind the study project is that the level of education and consequently the professional integration of patients with early pediatric ibd: 1) could be different from those of the general population; 2) and that these differences could be influenced by the nature of ibd, the age of its onset and its main characteristics. the main objective of this project is to assess the professional integration of these adult patients with pediatric-onset ibd and to compare it with the general population.

Eligibility criteria:
inclusion criteria: * male or female, aged 25 and over at the time of the study * subject listed in the epimad registry suffering from certain or probable crohn's disease, or certain or probable ulcerative colitis, or certain or probable ulcerated proctitis, unclassified colitis, diagnosed between 01/01 / 1988 and 12/31/2011, with an age at diagnosis of less than 17 years (definition of the pediatric cohort of the epimad registry) * patient residing in the area of the epimad registry: nord, pas-de-calais, somme or seine-maritime * patient not opposed to the research * patient not having objected to the use of their data for ancillary studies when registering in the epimad register exclusion criteria: * none
cyberbullying awareness training for secondary school students

Conditions: Cyberbullying

Summary: the study will be conducted with the randomized controlled experimental method. the purpose of this research is to determine the cyberbullying awareness training given to 7th-grade secondary school students' awareness levels of cyberbullying. students will be randomly assigned to groups by lottery method. after the randomization students in the intervention group will be given 'cyberbullying awareness training'. the cyberbullying awareness level of all students will be determined with the 'cyberbullying awareness scale' before and 3 months after the training. students in the control group will not be educated. the cyberbullying awareness level of the students in the control group will be determined with the 'cyberbullying awareness scale' when they are included in the research and 3 months later.


Eligibility criteria:
inclusion criteria: * being between the ages of 12 and 14, * no auditory, visual, or mental problems that would affect communication * speaking and understanding turkish at native level exclusion criteria: * being younger than 12 years old and older than 14 years old, * having auditory, visual, or mental problems that would affect communication * not speaking and understanding turkish at native level

Keywords: cyberbullying students school
immune dysfunction in allergic asthma

Conditions: Asthma

Summary: we are using anti-ige to investigate the role of pulmonary mast cells in asthma.

subjects with mild allergic asthma are examined before, immediately after and 2 months after a course of treatment with anti-ige. the following are examined: allergen skin tests, allergen induced asthma, peripheral blood basophils, pulmonary bronchial mucosal mast cells.

Eligibility criteria:
inclusion criteria: mild asthma, adults - exclusion criteria: children. on inhaled or systemic steroids -
vnotes in elective bilateral salpingectomy for sterilization

Conditions: Sterility, Female

Summary: objective: to compare the vnotes approach versus conventional laparoscopic approach to be used in elective bilateral salpingectomy for sterilisation as an opportunistic cancer prevention strategy. study design: prospective cohort, two-centred trial. study population: all women aged over 18 who are planned to undergo for definitive surgical sterilisation regardless of parity with a non-prolapsed uterus. primary outcomes: (1) patient satisfaction (at 1st week and 1st month of the surgery) measured by the patient global imression of improvement (pgi-i), (2) postoperative early pain (visual analog score (vas) at 6th and 24th hours of the surgery). secondary outcomes: (1) conversion to laparoscopy or laparotomy, (2) duration of the procedure, (3)total amount of analgesics used, (4) new-onset dyspareunia at first coitus measured by the pain subdomain of female sexual function index (fsfi), (5) intraoperative complications, (6) postoperative complications

women who are indicated or seek for surgical sterilisation are routinely offered salpingectomy rather than tubal ligation for cancer prevention purposes as a local protocol. those patients will be offered for vnotes approach after detailed patient counselling and will be enrolled to the study upon acceptation.

Eligibility criteria:
inclusion criteria: * women aged over 18 years regardless of parity with a non-prolapsed uterus * patients who are indicated or seek for definitive surgical sterilisation * patients who prefers salpingectomy over tubal ligation after considering its possible cancer prevention effect * written informed consent obtained prior to surgery exclusion criteria: * any malignancy * suspected rectovaginal endometriosis * history of pelvic inflammatory disease, pouch of douglas abscess * being virgo or pregnant * failure to provide written informed consent prior to surgery

Keywords: vnotes scarless surgery cancer prevention
evaluation of inspiratory muscle strength early after coronary artery bypass

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to evaluate the effects of a 6-day postoperative in hospital cardiopulmonary rehabilitation program on inspiratory muscle strength and its potential association with improved functional capacity after coronary artery bypass grafting surgery.

eligible patients were randomized to a cardiopulmonary rehabilitation program (rehab; n = 10) or to usual care (control; n = 10). the randomization was done by the graphpad statmate computerized program. those patients assigned to control were followed by their own physicians, received routine nursing assistance, were visited daily by the one of the investigators (cpm), but were not exposed to any specific respiratory or motor physical intervention. those randomized to rehab received the same medical and nursing care, but followed a structured physical therapy program twice a day.

Eligibility criteria:
inclusion criteria: * previous history of more than one vessel coronary artery disease * lifelong abstinence from tobacco * formal indication for cabg exclusion criteria: * patients older than 75 years of age * chronic renal failure (dialysis for more than 3 months) * unstable angina in the 48 hours prior to cabg * moderate or severe valve disease * complex cardiac arrhythmia's * stroke * inability to exercise the lower limbs * previous pulmonary disease (forced vital capacity \[fvc\] \< 80% of predicted and/or forced expiratory volume in 1 s \[fev1\] \< 70% of predicted) * previous history of asthma.

Keywords: physical therapy inspiratory muscles exercise
evaluation of ocular lens proteins in cataract from individuals with down syndrome

Conditions: Cataract; Down Syndrome

Summary: this study involves the collection ocular lens tissue from individuals with down syndrome and age-matched controls at the time of cataract surgery.

individuals with down syndrome have an increased rate of cataract. the reason for this increase is unclear. normally, once cataracts become a significant impairment, an ophthalmologist will determine when cataract surgery should be performed. when this surgery is performed, cataractous tissues are cut out and discarded with medical waste. in this study, these tissue will be collected and protein analysis performed to determine what changes in different proteins are found in down syndrome lenses as compared to normal cataractous lenses.

Eligibility criteria:
inclusion criteria: * undergoing cataract surgery for lens extraction. exclusion criteria: * known genetic cause other than down syndrome causing cataract.
assessment of long-term clinical response to bont in cervical dystonia

Conditions: Cervical Dystonia

Summary: the goal of this retrospective, international, multi-center chart abstraction is to learn about the long-term impact of product-specific immunogenicity-related factors in different botulinum neurotoxin type a formulations in patients suffering from cervical dystonia. the main question it aims to answer is: do complex-containing (cc) botulinum toxin formulations impact the long-term clinical outcome in cervical dystonia patients compared to a complex-free (cf) formulation? researchers will compare differences observed in years 2 and 7 between two toxin groups, i.e., botulinum neurotoxins type a containing complexing proteins (cc) and without complexing proteins (cf).

botulinum neurotoxin type a (bont/a) is first-line treatment in patients suffering from cervical dystonia. effect of bont/a is temporary and must be repeated to maintain clinical effect. as for all biologics, repeated treatment bears the risk of activating an immune response due to the immunogenic nature of foreign proteins. clinical signs of a potential immune response are reduced, or loss of efficacy, decreased duration of effect, and the need of a dose increase to maintain effect. due to the different degree of purity and protein content, it is reasonable to assume that commercial bont/a formulations differ in immunogenic properties. pivotal clinical trials and monocentric real-world studies demonstrated an increased incidence of neutralizing antibodies (nabs) and nab-associated partial or complete secondary non-response. however, the clinical relevance of potential immunogenicity-related mechanisms has not been demonstrated in a larger multicentric cohort in a real-world setting. this chart abstraction is designed to address this gap.

Eligibility criteria:
* clinical diagnosis of cervical dystonia * adults (m/f) 18-64 years of age at start of bont/a treatment * patient's written informed consent if required by local and/or national law.

Keywords: spasmodic torticollis, focal dystonia
comparison of inhaled nitric oxide and oxygen in participants reactivity during acute pulmonary vasodilator testing

Conditions: Idiopathic Pulmonary Arterial Hypertension; Cardiomyopathy

Summary: the primary purpose of this study is to compare the number of participants with reversible pulmonary hypertension (vasoreactivity) due to nitric oxide for inhalation and oxygen as compared to 100% oxygen.


Eligibility criteria:
inclusion criteria: 1. must have any one of these three disease categories: * idiopathic pulmonary arterial hypertension * mean pulmonary arterial pressure (papm) \> 25 millimeters of mercury (mmhg) at rest, pulmonary capillary wedge pressure (pcwp) ≤ 15 mmhg, and pvri\> 3 u•m\^2 or diagnosed clinically with no previous catheterization * congenital heart disease (chd) with pulmonary hypertension repaired and unrepaired * papm \> 25 mmhg at rest and pvri\> 3 u•m\^2 or diagnosed clinically with no previous catheterization * cardiomyopathy * papm \> 25 mmhg at rest and pulmonary vascular resistance index (pvri)\> 3 u•m\^2 or diagnosed clinically with no previous catheterization 2. scheduled to undergo right heart catheterization to assess pulmonary vasoreactivity by acute pulmonary vasodilation testing. 3. male or female, ages 4 weeks to 18 years, inclusive 4. signed informed consent/assent exclusion criteria: 1. focal pulmonary infiltrates on chest radiograph. 2. diagnosed with severe obstructive or restrictive pulmonary disease that is significantly contributing to the patient's pulmonary hypertension. 3. received treatment with nitric oxide for inhalation within 30 days prior to study initiation, are on other investigational medications, nitroglycerin, sodium nitroprusside, sildenafil, other phosphodiesterase type 5 (pde-5) inhibitors, or prostacyclin 4. pregnant \[urine human chorionic gonadotropin positive (hcg +)\] 5. baseline pulmonary capillary wedge pressure (pcwp) \> 20 mmhg

Keywords: pulmonary vasculature nitric oxide inomax® acute lung injury pulmonary vasodilator testing idiopathic pulmonary arterial hypertension congenital heart disease reversible pulmonary hypertension vasoreactivity congenital heart disease with pulmonary hypertension
effects of transvenous vagus nerve stimulation on immune response: a pilot study

Conditions: Inflammation

Summary: the purpose of this study is to assess the effect of transvenous vagus nerve stimulation (tvns) on the immune response. in the human endotoxemia model, intravenously administered endotoxin (lipopolysaccharide \[lps\]) elicits a systemic immune response with release of pro-inflammatory cytokines, such as tnf α. this trial will determine if an anti-inflammatory effect can be produced by acute vns using a minimally invasive delivery method.


Eligibility criteria:
inclusion criteria: 1. written informed consent to participate in this trial 2. male subjects aged 18 to 35 years inclusive 3. healthy as determined by medical history, physical examination, vital signs, 12 lead electrocardiogram, and clinical laboratory parameters exclusion criteria: * use of any medication(including herbal remedies and vitamin/mineral supplements) or recreational drugs within 7 days prior to profiling day * smoking * use of caffeine, or alcohol or within 1 day prior to profiling day * previous participation in a trial where lps was administered * surgery or trauma with significant blood loss or blood donation within 3 months prior to profiling day * participation in another clinical trial within 3 months prior to profiling day. * history, signs or symptoms of cardiovascular disease * an implant that in the opinion of the investigator may make invasive procedures risky for the subject due to the increased risks associated with a possible infection. * subject has an implanted active cardiac device (icd, ipg and/or crt) * implanted active neurostimulation device * subject has internal jugular vein that cannot be accessed * history of vaso-vagal collapse or of orthostatic hypotension * history of atrial or ventricular arrhythmia * resting pulse rate ≤45 or ≥100 beats / min * hypertension (rr systolic \>160 or rr diastolic \>90) * hypotension (rr systolic \<100 or rr diastolic \<50) * conduction abnormalities on the ecg consisting of a 1st degree atrioventricular block or a complex bundle branch block * subject is diagnosed with epilepsy or history of seizures * renal impairment: plasma creatinine \>120 µmol/l * liver function abnormality: alkaline phosphatase\>230 u/l and/or alt\>90 u/l * coagulation abnormalities: aptt or pt \> 1.5 times the reference range * history of asthma * immuno-deficiency * crp \> 20 mg/l, wbc \> 12x109/l, or clinically significant acute illness, including infections, within 2 weeks before profiling day * known or suspected of not being able to comply with the trial protocol * inability to personally provide written informed consent (e.g. for linguistic or mental reasons) and/or take part in the study.

Keywords: inflammation vagus nerve stimulation chronic heart failure systemic inflammatory response syndrome sepsis auto-immune diseases
biomarkers and postoperative delirium in elderly patients

Conditions: Postoperative Delirium

Summary: this study intends to verify and explore the correlation of neuroinflammation biomarkers in cerebrospinal fluid and plasma of elderly patients undergoing hip replacement with postoperative delirium, so as to achieve a new method to predict whether patients will develop postoperative delirium and improve the prognosis of elderly patients with postoperative delirium. reduce the probability of postoperative complications, improve the long-term survival rate of patients after surgery.


Eligibility criteria:
inclusion criteria: 1. age≥65 2. patients undergoing hip replacement under spinal anesthesia 3. asa grade i\~iii; 4. voluntarily participate in this study, and informed consent was signed by the patients themselves and their families exclusion criteria: 1. patients with multiple fractures and trauma 2. patients with preoperative cognitive dysfunction determined by mmse scale; 3. severe impairment of hearing, visual and language system functions; 4. not suitable for or unwilling to undergo subarachnoid anesthesia 5. patients who refuse to participate or cannot cooperate.