Kornimate/medical-research-clean huggingface dataset:
comparison between rituximab treatment and general corticotherapy treatment in patients with pemphigus

Conditions: Pemphigus Disease

Summary: pemphigus is a severe and sometimes life-threatening disease with a mortality rate between 5 and 10 percent depending on the severity of disease and age of patients. the standard of care is high doses of corticosteroids (cs) (usually, prednisone, 1 to 1.5. mg/kg/day, which are often associated with immunosuppressive drugs i.e., azathioprine, mycophenolate mofetil, cyclophosphamide, cyclosporine, although only one randomised study has demonstrated the superiority of the combination of corticosteroids and immunosuppressive drugs as compared to corticosteroids alone (9). because of the low frequency of the disease, control trials are difficult to conduct. evaluation of the different treatment regimens proposed, i;e; corticosteroids alone, cs and immunosuppressive drugs, iv immunoglobulins or new therapeutic regimens such as rituximab (an anti-cd20 monoclonal antibody directed against b- lymphocytes) or immunoadsorbtion.


Eligibility criteria:
inclusion criteria: * age \>=18 and \<= 80years * consent obtained from patient * effective female contraceptive method for women in procreate age * new case of pemphigus vulgaris (pv) or pemphigus foliaceus (pf) exclusion criteria: * pemphigus vulgaris (pv) or pemphigus foliaceus (pf) treated * pregnant woman or nursing mother * woman able to have a baby and without contraception during the clinical trial period * age \ 80 * karnovsky \< 50% * serious antecedents of allergy or anaphylactic reaction with human monoclonal antibody * patient with depletion lymphocytic treatment in the next month * unstable angina or ischemic heart disease * cardiac insufficiency * cardiac rhythm trouble uncontrolled * positive hiv serology * positive hepatitis b and / or c serology * no consent

Keywords: corticothérapy rituximab therapeutic efficacity therapeutic tolerance
intrauterine adhesion rate after hysteroscopic myomectomy and application of hyalobarrier gel

Conditions: Myoma

Summary: the purpose of this study is to evaluate the intrauterine adhesion rate after the application of hyalobarrier gel at the end of hysteroscopic myomectomy. secondary endpoints were tolerance and side effect and subsequent fertility.

hysteroscopic myomectomy is the referent surgical treatment for submucous myoma. but intrauterine adhesion rate was evaluated about 7 to 15% after this procedure. the investigators hypothetically believe that application of hyalobarrier gel at the end of the procedure, could be reduce the mean intrauterine rate to 50%. thus, the investigators performed a multicenter (n = 20) prospective study non randomized in 220 patients with submucous myoma \< 3 cm of diameter, evaluated by preoperative ultrasound. the investigators prefer this study design, because the principal reason is the number of enrolled patient were more 200 patients in each group with a double blind randomized study. now, in all patients, after hysteroscopic myomectomy which performed with a same technique in each center (bipolar coagulation and physiologic serum), a diagnostic hysteroscopy was performed at 2 month to determinate the existence of intrauterine adhesion. secondary end points were in this study the tolerance and side effects of hyalobarrier gel and the subsequent fertility at 2 years.

Eligibility criteria:
inclusion criteria: * 18 to 45 aged-patients * hysteroscopic diagnosis of one submucous myoma with less than 3cm diameter requiring operative hysteroscopy with saline type 0, 1 or 2 * negative plasmatic βhcg test * non opposition * patients with social security exclusion criteria: * multiple submucous myomas type 0, 1 or 2 * presurgical embolization * presurgical impregnation with gnrh agonist * coagulative disorders * malignancies * uncontrolled diabetes * operative hysteroscopy with glycine * known hypersensitivity to hyalobarrierr gel endo * infection of the surgical area concerned

Keywords: uterine synechiae hyalobarrierr gel endo operative hysteroscopy submucous myoma
two different tranexamic acid regimens in coronary artery bypass surgery

Conditions: Postoperative Hemorrhage

Summary: the primary aim of this study is to observe the effects of two different methods of administering tranexamic acid (i.v. bolus and i.v. infusion) routinely used intraoperatively in cardiovascular surgery, on patients' postoperative bleeding amounts. according to the hypothesis established in this study, it is anticipated that administering tranexamic acid as an i.v. bolus dose followed by an 8-hour continuous infusion will result in a more stable blood level compared to the sole i.v. bolus application, thereby being more effective in influencing postoperative bleeding levels. the study has been designed as a prospective observational research. the outcomes of two different tranexamic acid protocols applied during cardiovascular surgical procedures will be compared. the first group will consist of patients who receive a 10 mg/kg i.v. bolus of tranexamic acid after anesthesia induction, followed by an 8-hour i.v. tranexamic acid infusion at a dose of 2 mg/kg/hour. group 2 will consist of patients who receive three doses of tranexamic acid, 10 mg/kg i.v. bolus after anesthesia induction, in the pump, and after protamine sulfate administration. the cases collected over a period of 14 months will be divided into two groups and compared in terms of intraoperative and postoperative bleeding levels, as well as their need for blood products.


Eligibility criteria:
inclusion criteria: * patients who have coronary artery disease requiring coronary artery bypass surgery with cardiopulmonary bypass and received intravenous tranexamic acid either as a bolus or infusion during the intraoperative period will be included in the study. * writen consent obtained exclusion criteria: * patients operated on for reasons other than coronary artery bypass surgery * patients who operated on as emergencies * patients who have preoperative liver/renal dysfunction or a history of cerebrovascular events * patients under the age of 18 * patients who have coagulation disorder * patients who have a history of allergies * pregnancy or lactation * disabled in spirit or law

Keywords: tranexamic acid coronary artery bypass hemorrhage
stress reduction in improving quality of life in patients with recurrent gynecologic or breast cancer

Conditions: Anxiety Disorder; Depression; Fatigue; Leydig Cell Tumor; Ovarian Sarcoma; Ovarian Stromal Cancer; Pain; Peritoneal Carcinomatosis; Pseudomyxoma Peritonei; Recurrent Breast Cancer; Recurrent Cervical Cancer; Recurrent Endometrial Carcinoma; Recurrent Fallopian Tube Cancer; Recurrent Gestational Trophoblastic Tumor; Recurrent Ovarian Epithelial Cancer; Recurrent Ovarian Germ Cell Tumor; Recurrent Primary Peritoneal Cavity Cancer; Recurrent Uterine Sarcoma; Recurrent Vaginal Cancer; Recurrent Vulvar Cancer

Summary: this pilot clinical trial studies stress reduction in improving quality of life in patients with recurrent gynecologic or breast cancer. participating in a stress reduction program may help improve quality of life in patients with gynecologic or breast cancer.

primary objectives: i. to refine the intervention. ii. test the acceptability, feasibility, and clinical appropriateness of the intervention. iii. to provide a preliminary test of its efficacy. outline: patients participate in a multi-component intervention based on cognitive and behavioral principles comprising mindfulness-based stress reduction (mbsr), an intervention to promote hopefulness, and a problem solving approach which navigates around obstacles or generates alternatives when goals become blocked. additional topics may be covered as indicated by clinical need and patients goals. biobehavioral components include addressing social and disease-specific quality of life, and pain education. intensive treatment sessions continue weekly for 16 weeks followed by 2 biweekly and 2 monthly maintenance sessions. after completion of study treatment, patients are followed up at 28 weeks.

Eligibility criteria:
inclusion criteria: * diagnosis of recurrent breast or gynecologic cancer (any site) with any disease-free interval; second primary cancers do not meet this criterion * english speaking * able and willing to give informed consent * to be considered for the blood and saliva collection, women must fulfill the following secondary criteria: * diagnosis of recurrent breast or ovarian cancer with any disease-free interval exclusion criteria: * residence \> 70 miles from research site * subnormal intellectual potential (diagnosis of mental retardation) * progressive neurological or chronic, progressive, debilitating condition (e.g., dementia) * non-ambulatory * life expectancy less than 160 days, per the treating oncologist * current suicide risk sufficient to preclude treatment on an outpatient basis * chronic inflammatory or autoimmune disorder (e.g., rheumatoid arthritis, lupus)

Keywords: psychological intervention breast cancer gynecologic cancer
the effects of thymopentin on hiv infectivity of blood cells and semen in hiv-infected patients

Conditions: HIV Infections

Summary: examine the ability of timunox (thymopentin) to reduce the amount and/or frequency of virus isolation. examine the ability of thymopentin to stimulate the immune system and alter the clinical findings in patients infected with hiv who do not yet have aids.


Eligibility criteria:
inclusion criteria concurrent medication: allowed: * aerosolized pentamidine. patients must have the following: * seropositive for hiv-1 (elisa assay) confirmed by western blot. * hiv-1 p24 antigen must be detected in supernatant fluids from co-cultures of patients' peripheral blood monocytes (pbmc) on two separate occasions. * voluntarily sign consent. * patients with hiv "wasting syndrome" are allowed. prior medication: allowed: * aerosolized pentamidine. exclusion criteria co-existing condition: patients with the following are excluded: * aids as defined by the cdc. * significant hepatic disease. * thrombocytopenia. * hypersensitivity to thymopentin. * hemophilia a or b or other hematologic disorders requiring current or previous administration of blood products. * abnormal chest x-ray (indicative of active disease (opportunistic infection)) within 30 days prior to study entry. patients with the following are excluded: * aids as defined by the cdc. * significant hepatic disease. * thrombocytopenia. * hypersensitivity to thymopentin. * hemophilia a or b or other hematologic disorders requiring current or previous administration of blood products. * abnormal chest x-ray (indicative of active disease (opportunistic infection)) within 30 days prior to study entry. prior medication: excluded within 30 days of study entry: * immunomodulatory or experimental therapy. * excluded within 90 days of study entry: * zidovudine (azt). intravenous drug abuse.

Keywords: semen thymopentin leukocytes, mononuclear hiv seropositivity aids-related complex
quality of life after poem for achalasia

Conditions: Esophageal Achalasia

Summary: achalasia is an esophageal motility disorder, characterized by insufficient lower esophageal sphincter relaxation and loss of esophageal peristalsis. patients with achalasia experience distressing gastrointestinal symptoms, including dysphagia, reflux and chest pain, which lead to weight loss and malnutrition. undoubtedly, health-related quality of life can be significantly diminished in patients with achalasia. at present, poem has become one of the standard therapies for achalasia. limited studies have focused on the patient's quality of life before and after poem. the present study aimed to assess the changes in quality of life of patients with achalasia using the validated achalasia severity questionnaire (asq) and the short form (sf)-36 scale.


Eligibility criteria:
inclusion criteria: * diagnosed as achalasia base on high resolution manometry, barium esophagram and upper endoscopy * scheduled to undergo poem for treatment of achalasia exclusion criteria: * coagulopathy and systemic disorders that precluded safe general anesthesia

Keywords: esophageal achalasia, peroral endoscopic myotomy, quality of life
assessment of interstitial lung disease in rheumatoid arthritis by lung ultrasound

Conditions: Lung Diseases; Lung Diseases, Interstitial; Rheumatoid Arthritis

Summary: the high resolution chest scan is the gold standard for the screening of interstitial lung disease, but this remains an onerous examination, and irradiating. ultrasound could be used to detect these disorders with a very good sensitivity and specificity. this exam offers the advantage of being non radiating, inexpensive, and accessible to the rheumatologist who already uses it in their daily practice. the investigators want to assess the lung ultrasound performance compared with the gold standard. patients will be included during a regular follow-up consultation with their referent rheumatologist. if there is an indication of first line biotherapy or targeted therapy the doctor will propose to the patient to participate in the study, give him the information leaflet, collect orally non-opposition, and will complete a survey for evaluation of the general health and potential risk factors for interstitial lung.


Eligibility criteria:
inclusion criteria: * men and women over the age of 18 * with rheumatoid arthritis meeting the criteria acr (american college of rheumatology)/ eular (european league against rheumatism) 2010 * never received any biotherapy or targeted therapy * having an indication of introduction of biotherapy or therapy targeted (jak inhibitors) (jak : janus kinase) exclusion criteria: * refusal to participate in the study * known pulmonary disease that can alter lung interstitium: cardiac decompensation, copd (chronic obstructive pulmonary disease), thoracic surgery, infection pulmonary * patient with respiratory functional signs suggestive of pid (diffuse interstitial lung disease) * patient with signs of cardiac decompensation * patient with pulmonary auscultation suggestive of pid * pregnant or lactating woman * psychiatric pathology seriously hindering understanding * difficulty understanding oral french * person deprived of liberty or under legal protection
investigation on safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of a long acting glp-1 analogue (nnc0113-0987) in healthy male subjects

Conditions: Diabetes; Healthy

Summary: this trial is conducted in europe. the aim of the trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of multiple doses of a long acting glp-1 analogue (nnc0113-0987) in healthy male subjects.


Eligibility criteria:
inclusion criteria: * male, who is considered to be generally healthy, based on the medical history, physical examination and the results of vital signs, electrocardiogram (ecg) and laboratory safety tests performed during the screening visit, as judged by the investigator * age 18-64 years (both inclusive) at the time of signing informed consent * bmi (body mass index) 20.0-29.9 kg/m\^2 (both inclusive) exclusion criteria: * history of, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal (gi), endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator * personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 * history of chronic pancreatitis or idiopathic acute pancreatitis * use of prescription or non-prescription medicinal and herbal products (except routine vitamins) within three weeks preceding the dosing period. occasional use of paracetamol or acetylsalicylic acid is permitted * subject with previous gi surgery, except subjects that underwent uncomplicated surgical procedures such as appendectomy, hernia surgery, biopsies, as well as colonic and gastric endoscopy
rivaroxaban versus warfarin for antithrombotic therapy in patients with left ventricular thrombus after acute stemi

Conditions: Left Ventricular Thrombus; ST Segment Elevation Myocardial Infarction

Summary: the purpose of the study is to assess the safety and efficacy of rivaroxaban-based versus warfarin-based antithrombotic regimens on outcomes of patients with left ventricle thrombosis following acute st elevation myocardial infarction at 3 months from enrollment in an open-label parallel groups pilot randomized clinical trial

direct oral anticoagulants (doacs), are currently recognized as the first-line treatment of af and vte in most clinical scenarios, distinguished by their short half-life, fast onset of action, fewer medication interactions, rare food interactions, and the lack of a need for frequent laboratory monitoring, compared with vitamin k antagonists. although the use of doacs has earned a class iii recommendation for patients with mechanical prosthetic valves, moderate-to-severe mitral stenosis, and antiphospholipid syndrome, their application in some situations, such as acute limb ischemia and lvt, remains uncertain. until now, no completed randomized clinical trial has compared the efficacy and safety of left ventricle thrombosis in patients with acute stemi and the existing evidence is limited to observational studies.

Eligibility criteria:
inclusion criteria 1. adult patients aged 18-80 years 2. admission with acute stemi in past 2 weeks 3. acute lvt confirmed by non-contrast tte 4. willingness to participate and to provide a signed informed consent form exclusion criteria 1. history of the mechanical prosthetic heart valve, rheumatic heart disease, and confirmed case of antiphospholipid syndrome 2. active bleeding 3. cardiogenic shock defined as persistent hypotension (systolic blood pressure \ 90 mm hg) and clinical signs of hypoperfusion (cold, sweated extremities, oliguria, mental confusion, dizziness, narrow pulse pressure) 4. acute kidney injury or chronic kidney disease with a glomerular filtration rate \<30 ml/min (calculated based on the cockcroft-gault formula) 5. liver failure (child-pugh class c) 6. other indications for chronic anticoagulation (e.g., af, vte, etc.) 7. sensitivity or intolerance to rivaroxaban/warfarin

Keywords: left ventricle ventricle, left thrombosis thromboses blood clot st segment elevation myocardial infarction st elevated myocardial infarction stemi
gait pattern and experienced global change after shunt surgery in idiopathic normal pressure hydrocephalus

Conditions: Idiopathic Normal Pressure Hydrocephalus

Summary: part 1 patients with idiopathic normal pressure hydrocephalus (inph) have variable disabilities regarding gait, balance, cognition and continence. analysis of the gait pattern in inph has an important part in clinical diagnosing and evaluation of outcome after shunt surgery. the gait pattern is only partly explained and more detailed information about gait in inph is needed in relation with ordinary clinical measurements. part 2 approximately 70 % of patients with inph improve after shunt surgery. commonly different grading scales and measurements regarding functions are used in the evaluation. to some extent, patients improve in quality of life after surgery (qol). in this study, the patient´s own grading of improvements in relation with qol, sense of coherence (soc) and symptoms of depression and anxiety are analyzed.

consecutive patients with inph, which are planed for shunt surgery at the neurological and neurosurgical departments of university hospital of linköping, are included. before operation and 3 months postoperatively, the patient´s gait pattern are analyzed with rehagait analysis system. the patients also fill in a questionnaire about soc, qol and symptoms of depression and anxiety at these assessment sessions. additionally at the follow up, the patients are grading their overall experienced change and specified changes in gait, balance, continence and neuropsychology with the global rating of change scale (grc-scale). at baseline and at follow up, the patients also perform the ordinary clinical assessments with measurements covering the domains gait, balance, continence and neuropsychology in the inph-scale. a convenience sample of healthy individuals aged \> 60 years, conduct the same questionnaires: soc, qol and symptoms of depression and anxiety and perform the rehagait analysis system once.

Eligibility criteria:
inclusion criteria for patients: * inph-diagnosis according to the international guidelines (2005) * planed for shunt surgery exclusion criteria for patients: * cognitive impairment that makes it impossible to participate * not able to walk 20 meters without walking aids (part 1) inclusion criteria for healthy individuals: * \> 60 years of age * subjectively healthy without any serious disease exclusion criteria healthy individuals: * visible gait- or balance disturbance * dementia diagnosis

Keywords: gait analysis outcome surgery
a research study on how well semaglutide works in adolescents with overweight or obesity

Conditions: Overweight; Obesity

Summary: this study will look at the change in teenagers' body weight from the start to the end of the study. this is to compare the effect on body weight in teenagers taking semaglutide (a new medicine) and teenagers taking "dummy" medicine. the teenagers in the study and their parents will also have talks with study staff about healthy food choices, how to be more physically active and what they can do to help the teenagers lose weight. the teenagers will either get semaglutide or "dummy" medicine - which treatment is decided by chance. the teenagers will take 1 injection every week, on the same day of the week for about 15 months. the study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. the teenagers will have 17 clinic visits, will have blood samples taken and will have to complete questionnaires and keep a diary. all this will be explained before study start.


Eligibility criteria:
inclusion criteria: * informed consent of parent(s) or legally acceptable representative of subject and child assent, as appropriate obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * male or female, ages 12 to below 18 years at the time of signing informed consent * bmi equal to or above 95th percentile or equal to or above 85th percentile (on gender and age-specific growth charts (cdc.gov)) with 1 or more weight related comorbidity (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or type 2 diabetes * history of at least one self-reported unsuccessful dietary effort to lose weight for subjects with type 2 diabetes at screening the following inclusion criteria apply in addition: - hba1c equal to or below 10.0% (86 mmol/mol) as measured by central laboratory at screening exclusion criteria: * prepubertal subjects (tanner stage 1) * history of type 1 diabetes * a self-reported (or by parent(s)/legally acceptable representative where applicable) change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records * subjects with secondary causes of obesity (i.e., hypothalamic, monogenic or endocrine causes) * for subjects with type 2 diabetes only: uncontrolled and potentially unstable diabetic retinopathy or maculopathy. verified by a fundus examination performed within the past 90 days prior to screening. pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination