Kornimate/medical-research-clean huggingface dataset:
the banded mini gastric bypass trial: a prospective randomized controlled trial

Conditions: Bariatric Surgery; Weight Loss; Comorbidities and Coexisting Conditions

Summary: rationale: investigate if there is a significant weight reduction expressed in total body weight loss percentage (%tbwl) in patients 5 years after surgery, whom underwent a mini gastric bypass (mgb-oagb) with addition of the implantation of a minimizer ring. study design: a prospective non blinded single centre randomized controlled trial. sudy population: the study population will exist of patients eligible for mgb-oagb surgery. patients are invited to participate if body mass index (bmi) ≥ 35kg/m2 with a comorbidity related to morbid obesity, or a bmi exceeding 40kg/m2. intervention: insertion of the minimizer ring around the gastric pouch in addition to the 'standard' mgb-oagb. main study parameters/endpoints: primary objective: 1. %tbwl 5 years after surgery. secondary objectives: 2. percentage excess weight loss (%ewl) 5 years after surgery. 3. decrease or reduction of comorbidities (diabetes mellitus, hypertension, hyperlipidemia, sleep apnoea, and joint complaints). 4. improvement of quality of life: sf-36 and obesi-q questionnaires. 5. incidence and severity of dumping syndrome. 6. incidence and severity of reflux symptoms: gerd-hrqol questionnaire. 7. incidence and complications due to silicone band. measurement of objectives are before surgery and six times after surgery combined with the standard postoperative care for patients who undergo bariatric surgery: expected advantages of bolgb versus olgb: 1. increase of weight reduction, and due to that decrease of comorbidities and/or mortality related to overweight. 2. long term decrease of weight regain. 3. decrease of incidence of dumping. possible disadvantages of bolgb versus olgb: 1. band-related complications such as erosion, infection, stenosis, or pouch dilatation. 2. functional gastro-intestinal complains such as dysphagia and reflux.


Eligibility criteria:
inclusion criteria: * patients meet ifso criteria for bariatric surgery * age 18 and above exclusion criteria: * previous bariatric surgery * inability to read and understand written information * any genetic condition that can hamper the acceptance of medical advice * chronic bowel disease * severe kidney of liver disease * pregnancy at the start or during the research period * patients with pre-existing therapy refractory gerd * patients with an allergy to silicone

Keywords: mgb-oagb minimizer ring banded bypass
treatment with tnf blockade, infliximab, in patients with myositis

Conditions: Refractory Myositis

Summary: this is a 4 month open trial with tnf-blockade using infliximab (an antibody that blocks tnf) in adult patients with chronic myositis (polymyositis, dermatomyositis, inclusion body myositis) who have persisting muscle weakness and inflammatory active disease despite adequate treatment with immunosuppressives either currently or previously. infliximab is given as infusions, 5 mg/kg body weight, these infusions are repeated after 2, 6 and 14 weeks. the study involves 15 adult patients. primary outcome measure is muscle function assessed by muscle function index score. other outcome measures are myositis disease activity core set: patient's global assessment and physicians global assessment on visual analogue scales (vas). manual muscle test, health assessment questionnaire (haq), serum levels of cpk, ld and extra muscular disease activity score. muscle biopsy, magnetic resonance imaging (mri) of thigh muscles and health related quality of life, measured by sf-36.


Eligibility criteria:
inclusion criteria: * adult patients. * persisting muscle weakness defined as ≤ 80% of muscle strength as measured by functional index of myositis * signs of disease activity defined as muscle edema observed by magnetic resonance imaging (mri) or creatine kinase (ck) elevation, or inflammatory cell infiltrates on muscle biopsy, and failure to respond to treatment with glucocorticoids for a minimum of six months in combination with azathioprine or methotrexate. exclusion criteria: * pregnant women, nursing mothers or a planned pregnancy within one and a half years of enrolment. * prior administration of infliximab or any other therapeutic agent targeted at reducing tnf (e.g., etanercept, pentoxifylline, thalidomide or anti-cd4+ antibody) within the previous six months. * a history of known allergies to murine proteins. * serious infections, such as hepatitis, pneumonia, pyelonephritis in the previous 3 months. less serious infections in the previous 3 months, such as acute upper respiratory tract infection (colds) or uncomplicated urinary tract infection (colds) or uncomplicated urinary tract infection need not to considered exclusions at the discretion of the treating physician. * history of opportunistic infections such as herpes zoster within 2 months of screening. evidence of active cmv, active pneumocystis carinii, drug resistant atypical mycobacterium, etc. * documented hiv infection. * current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease. * any currently known malignancy or pre-malignant lesions or any history of malignancy within the past five years. * patients with alcoholism, alcoholic liver disease, or other chronic liver disease. * patients with a positive ppd and chest x-ray suggestive of active tb or a previous exposure to tb.

Keywords: infliximab polymyositis dermatomyositis inclusion body myositis
alterations in cognitive function and cerebral blood flow after conversion from calcineurin inhibitors (cnis) to everolimus

Conditions: End Stage Renal Disease

Summary: the purpose of this study is to learn if changing from tacrolimus to everolimus will improve cognitive function by having less effect on brain blood flow.


Eligibility criteria:
inclusion criteria: * english speaking * able to sign informed consent * able to arrange transportation to and from study site * without acute stroke, concussion or traumatic brain injury * without acute medical issues at the time of participation * at least 12 weeks post kidney transplant surgery exclusion criteria: * are claustrophobic or have other contra-indication for magnetic resonance imaging (mri) * have hearing or visual impairment * are unable to read, write, speak or understand english * have uncontrolled psychosis or seizure disorder or are currently using antipsychotics or anti-epileptics * taking envarsus at the time of recruitment

Keywords: kidney transplant cognitive function
mhealth mood management tool (actify) to improve population-level smoking cessation

Conditions: Cigarette Smoking-Related Carcinoma

Summary: this phase i trial investigates a new smartphone application (called actify) for improving population-level smoking cessation and mood management. actify delivers behavioral activation therapy for depression as part of a smoking cessation intervention and will be compared to another smoking cessation smartphone application that is based on current clinical practice guidelines. participants will be randomly assigned to receive one of two smartphone applications and accompanying text notifications to help with quitting smoking and improved mood.

outline: participants are randomized to 1 of 2 arms. arm i: participants use actify app for smoking cessation for 8 weeks. participants also receive motivational messages and smoking cessation information via text notifications. arm ii: participants use united states (us) clinical practice guidelines (uscpg) app for smoking cessation for 8 weeks. participants also receive motivational messages and smoking cessation information via text notifications. after completion of study, participants are followed up at 6 months.

Eligibility criteria:
inclusion criteria: * current smoker, averaging at least 5 cigarettes/day for the last 30 days * interested in quitting smoking in the next 30 days * experience downloading and using one or more apps on their smartphone * either screens negative (patient health questionnaire - 9 item \[phq-9\] score 0-4) for depression or screens positive for mild to moderate current depressive symptoms (phq-9 score 5-19) * willing and able to complete all study activities * comfortable reading and writing in english * have a mobile data plan and/or access to wifi to support the use of the actify app * reside in the us * have a smartphone either an iphone (running ios version 11 or higher) or an android phone (running version 5.0 or higher) exclusion criteria: * currently receiving behavioral treatment for depression (e.g., psychotherapy) * current use of a depression app * severe depression (phq-9 \>= 20) * receiving other treatment for smoking cessation * previous use of the quitguide app * current or recent (within the past year) enrollment in a fred hutch smoking cessation study * employees/family of investigator or study center * member of the same household as another participant * woman who is pregnant or breastfeeding, or planning to become pregnant * currently incarcerated * is ineligible per fraud prevention protocol
digestive dysmotility in mitochondrial neurogastrointestinal encephalomyopathy

Conditions: MNGIE; Dysmotility

Summary: mitochondrial neurogastrointestinal encephalopathy (mngie) is an ultra-rare mitochondrial disease caused by mutations of the gen that codifies the enzyme thymidine phosphorylase the genetic defect results in systemic accumulation of the nucleosides thymidine and deoxyuridine. clinically mngie is characterized by a combination of gastrointestinal and neurological manifestations, including severe gastrointestinal dysmotility, cachexia, ptosis, external ophthalmoplegia and sensorimotor neuropathy. gastrointestinal symptoms are the most frequent first manifestation of the disease, and include early satiety, nausea, dysphagia, postprandial emesis, abdominal pain, abdominal distention, and diarrhea. the disease is relentlessly progressive and the cause of death is primarily related to digestive dysmotility. however, the specific motor dysfunctions that produce the symptoms, i.e., the underlying mechanisms, remain uncertain.

mitochondrial neurogastrointestinal encephalopathy (mngie) is an ultra-rare mitochondrial disease caused by mutations of the gen that codifies the enzyme thymidine phosphorylase the genetic defect results in systemic accumulation of the nucleosides thymidine and deoxyuridine. clinically mngie is characterized by a combination of gastrointestinal and neurological manifestations, including severe gastrointestinal dysmotility, cachexia, ptosis, external ophthalmoplegia and sensorimotor neuropathy. gastrointestinal symptoms are the most frequent first manifestation of the disease, and include early satiety, nausea, dysphagia, postprandial emesis, abdominal pain, abdominal distention, and diarrhea. the disease is relentlessly progressive and the cause of death is primarily related to digestive dysmotility. however, the specific motor dysfunctions that produce the symptoms, i.e., the underlying mechanisms, remain uncertain, because so far, no studies on gastrointestinal motility in mngie have been published. the aims of this study were to identify the upper gi motor dysfunction in mngie patients, and to determine their relation to the clinical manifestations. since the life-threatening consequences of the disease involve the upper gastrointestinal tract, all patients, after a thorough clinical and neurological evaluation, fulfilled a structured clinical questionnaire on digestive manifestations, and underwent state-of-the-art evaluation of the esophagus and the small bowel by high-resolution manometry (hrm), and gastric emptying by scintigraphy

Eligibility criteria:
inclusion criteria: * diagnosis of mngie disease established by thymidine phosphorylase activity and mitochondrial mutation analysis.

Keywords: intestinal manometry motility
efficacy of ultrasound-guided transversalis fascia plane block (tfpb) in controlling postoperative pain after transverse incision in gynecologic surgery

Conditions: Transversalis Fascia Plane Block; Gynecologic Surgical Procedures

Summary: transversalis fascia plane block (tfpb) has been studied and has shown to be very effective in controlling postoperative pain after caesarean section but has not been studied in open gynecologic surgery with transverse incision. inadequate pain control after open gynecologic surgery is associated with negative consequences such as chronic pelvic pain. we would like to study the efficacy of tfpb in controlling postoperative pain after open gynecologic surgery with transverse incision.


Eligibility criteria:
inclusion criteria: * patients who undergoing open gynecologic surgery under general anesthesia * age 18 - 70 years * asa physical status i-iii * transverse incision exclusion criteria: * creatinine clearance is less than 30 ml/min * body weight \< 50 kg * re-open surgery * persistent chronic pelvic pain * allergic to medications used in this study

Keywords: transversalis fascia plane block open gynecologic surgery transverse incision
therapeutic exercise and vegan diet on pain and quality of life

Conditions: Chronic Idiopathic Neck Pain

Summary: 45 sedentary volunteer female individuals whose age range is between 18-25 years and diagnosed with chronic idiopathic neck pain by a specialist physical therapy doctor will participate in the study. participants will be randomly divided into three groups: vegan diet group (n=15), therapeutic exercise group (n=15) and control group (n=15). participants with chronic neck pain who will be on a vegan diet will follow a diet program prepared by an expert dietitian under the supervision of an endocrinologist. in this diet program, a diet that includes grains, fruits, vegetables, legumes, as well as dairy products and eggs, known as lacto-ovo vegetarian, will be applied. consumption of meat, poultry, fish, seafood and processed food and beverages will not be allowed. there will be no calorie restriction in the diet, and the diet will be arranged according to the amount of calories calculated by the expert dietitian according to bmi. the diet will last eight weeks. individuals who follow a diet will be constantly checked by the workers with the mobile device application (my fitness pal®). individuals in the therapeutic exercise group will perform therapeutic exercises for eight weeks, 3 days a week, accompanied by a specialist physiotherapist.the aim of this study is to compare the effect of therapeutic exercise and vegan diet on pain and quality of life in young women with chronic idiopathic neck pain.


Eligibility criteria:
inclusion criteria: * individuals aged 18-25, * neck pain for at least 3 months, * vas score greater than 5 exclusion criteria: * using regular analgesic, * having had neck surgery, * the presence of neurological or specific problems in the neck (vertebral fracture, inflammation, infection, etc.), * cortisone use, * pregnancy, * serious chronic diseases, * those with serious psychiatric disorders * individuals who received physical therapy within 3 months * antidepressant use
effects of low frequency magnetic field on exercise induced angina

Conditions: Angina Exacerbation Acute

Summary: the investigators have previously shown that a frequency of 15.95-16.00 hz protects against acute myocardial infarction in rats. in the current study the investigators would like to investigate whether this frequency enables cardiac patients with exercise-induced chest pain to exercise at higher workload and heart rate. therefore, patients will undergo two exercise stress tests, one test after being exposed to 30 minutes of the above mentioned frequency and another test after being exposed to sham (no frequency is turned on). the investigators will measure changes in the electrocardiogram (ecg), workload, exercise time, and subjective measure of chest pain (angina).

several studies have shown that low frequency electromagnetic field has biological and therapeutic potential on the human body, however, to very limited extent on the heart. in the current study cardiac patients suffering from exercise-induced-angina will undergo two consecutive stress tests, one test after being exposed for 30 minutes to the magnetic field and the other test after being exposed to placebo (magnetic field not operated). the order of which the magnet will be operated will be randomly assigned for the patients so a group of patients will be exposed to the magnetic field at their first stress test and another groups of patients will be exposed to the magnetic field at their second stress test. during resting period, and while the patients are subjected to the magnetic field, a 12 lead electrocardiogram (ecg) will be monitored. thereafter the magnetic field and frequency will be turned off and the patients will be subjected to graded exercise stress test during which they will be monitored for ecg and blood pressure changes. similar monitoring will be documented during the recovery period following the stress test. in addition, the patients will grade their angina score as documented during the stress test. the data will be compared between the two stress tests and to document any advantageous of the magnetic field on exercise time, workload, ecg changes and/or chest pain.

Eligibility criteria:
inclusion criteria: patients with known exercise-induced-angina exclusion criteria: patients that changed treatment course between the two exercise stress tests patients that decided to drop from the second exercise stress test

Keywords: exercise stress test effort angina exercise induced angina
capsule microbiota sampling in ibs/functional gastrointestinal disease

Conditions: IBS - Irritable Bowel Syndrome; Healthy; Functional Bloating; Functional Gastrointestinal Disorders

Summary: we will sample intestinal microbiota using a microbiome sampling capsule in healthy, irritable bowel syndrome (ibs), and functional gastrointestinal disease.


Eligibility criteria:
inclusion criteria: * males or females 18 years of age or older and 70 years of age or younger at the time of the first screening visit. * american society of anesthesiologists (asa) physical status classification system 1 or 2 (1-a normal healthy patient or 2-a patient with mild systemic disease) * for women of childbearing potential, negative urine pregnancy test within 7 days of screening visit. willingness to use highly effective contraception during the entire study period (e.g.: implants, injectables, oral contraceptives, intra-uterine device or declared abstinence). * subject is fluent in english and understands the study protocol and informed consent and is willing and able to comply with study requirements and sign the informed consent form. * positive for at least one clinical symptoms consistent with sibo and or ibs and or a rome diagnosis of functional gi disorder (rome iv criteria) exclusion criteria: * history of any of the following: * prior gastric or esophageal surgery, including lap banding or bariatric surgery * bowel obstruction * gastric outlet obstruction * diverticulitis * inflammatory bowel disease * ileostomy or colostomy * gastric or esophageal cancer * achalasia * esophageal diverticulum * active dysphagia or odynophagia * active medication use for any gastrointestinal conditions * pregnancy or planned pregnancy within 30 days from screening visit, or breast-feeding * any form of active substance abuse or dependence (including drug or alcohol abuse), unstable medical or psychiatric disorder, or any chronic condition susceptible, in the opinion of the investigator, to interfere with the conduct of the study

Keywords: microbiome small intestine
effects on social and cognition functions of blonanserin in first episode schizophrenia patients

Conditions: First Episode Schizophrenia; Social Function; Cognition Function; Blonanserin

Summary: this is an open label, multi-center study to explore the effects on social functions of blonanserin in first episode schizophrenia patients


Eligibility criteria:
inclusion criteria: * schizophrenia patients diagnosis either with dsm-5 criteria or icd-10; * panss total score ≥70; * males or females aged 18-45 years; * with disease course less than 5 years and during their first episode; * ≥9 years of education; * without receiving systematic antipsychotic treatment, or receiving continuous antipsychotic treatment for less than 6 weeks and receiving antipsychotic treatment for less than 6 months in total; * ability to read and understand chinese; * provision of written informed consent exclusion criteria: * severe or unstable physical diseases judged by investigators; * loss of consciousness more than 1 hour due to any reason in the past 1 year; * current substance misuse (in 3 months) or any substance dependence; * pregnant or lactating woman; * patients with attempted suicide history, severe suicidal ideation or behaviour; * mental retardation; * contradict to the study drugs; * patients taken other investigation products in the past 30 days before entry; * patients ever taken blonanserin before; * any current medical condition that would interfere with the assessment of efficacy; * physical symptoms of acute deterioration requiring hospitalization or increased intensive care; * significant muscle tension or parkinson's disease; * clinically significant abnormal laboratory test results (blood, urine, and blood biochemical analysis); * clinically significant abnormal electrocardiogram as judged by researchers; * participants continuously using sedative drugs, or anticholinergic agents within 3 months of the study; * those who had undergone electroconvulsive therapy within 3 month of the study; * those who had received long-acting injection treatment within 3 month of the study; * those who could not swallow medication with water; * subjects judged by the investigator in charge as inappropriate for the study