Kornimate/medical-research-clean huggingface dataset:
omt as an adjunctive treatment in mdd

Conditions: Major Depressive Disorder

Summary: participants will be receiving omt 1x/week for 8 weeks. each appointment with be a duration of 30 minutes. patients will be required to fill out phq-9 and sss-8 questionnaires before beginning the study and following the conclusion of the study.

individuals will receive weekly omt for a duration of 8 weeks. primary assessment will be performed on initial visit, making note of the most severe somatic restrictions, but highest priority will be given to cervical and shoulder regions (most tension is noted here in patients with mdd). focusing on only the cranial, cervical, and shoulder regions will allow for a more standardized approach to treatment. osteopathic manipulative treatment (omt) is the manipulation of tissues (muscles, joints, fascia, etc.) that is used to help restore movement and function throughout the body by a combination of stretching, gentle pressure, and resistance. the techniques we have chosen to use will focus primarily on muscle and fascia in the cranial, cervical, and shoulder regions. cranial techniques used include: suboccipital release - this helps to relieve muscle and fascial tension surrounding the head and neck, patient is supine, physician places finger pads below occipital protuberance at the base of the occiput as patient's relaxes head and lets it rest on physician's finger pads, position is held until softening of musculature is felt vault hold - helps to restore cranial motion, patient is supine, physician places index finger on greater wing of sphenoid, middle finger on squamous portion of temporal bone, ring finger on mastoid process of temporal bone, and pinky finger on squamous portion of occipital bone, hands remain in this position to monitor cranial motion and determine if there is a dysfunction they will not be performing any high velocity low amplitude (hvla) techniques, which requires a rapid, therapeutic force within the motion of the joint (this is the technique that is often responsible for the "cracking" or "popping")

Eligibility criteria:
inclusion criteria: * patients 18-65, patients with diagnosis of mdd, phq-9 score \> 10 at screening and baseline exclusion criteria: * history of mania, hypomania, or psychosis as defined in dsm v * current substance abuse, including abuse within the previous 6 months * patients with a cognitive disorder or dementia * patients with other axis i diagnosis (anxiety disorders, dissociative disorders, etc.) that was primary in the past 6 months * receiving other forms of manual therapy during study * authors belief that there was significant suicidal risk * changes in medication or psychotherapy within 6 weeks of starting study or during study period * history of migraines * presence of any other significant organic disease (infectious, cardiac, pulmonary, gastrointestinal, renal, etc.) * other absolute contraindications to omt (malignancy, infection, myelopathy, severe osteoporosis, increased icp, intracranial bleeding, fractures, etc.)
quality of life in non-alcoholic fatty liver disease (qolnafld)

Conditions: Non-Alcoholic Fatty Liver Disease

Summary: non-alcoholic fatty liver disease (nafld) is a highly prevalent disorder which is directly linked to lifestyle patterns and is associated with poor quality of life, increased fatigue and psychological distress. the aim of the current study is to evaluate quality of life, fatigue and psychological functioning in nafld patients and assess the impact of systematic counseling on patients' psychosocial functioning.

introduction: the term non-alcoholic fatty liver disease (nafld) encompasses a spectrum of disorders ranging from simple steatosis to steatohepatitis, in the absence of other known causes of liver steatosis. nafld is a highly prevalent disorder which is directly linked to patients' lifestyle and is accompanied by severe co-morbidities. although there is a wealth of studies on nafld's pathogenesis, natural course and treatment, few investigations have focused on patients' quality of life (qol) and even fewer have evaluated the impact of therapeutic interventions on patients' quality of life and psychosocial functioning. in this context, there is a significant literature gap, given that modern research and clinical practice should aim at meeting patients' subjective physical and psychosocial needs and improving their overall quality of living. aim-methods: in this context, the aim of the present study is to assess the effect of systematic counseling on nafld patients' quality of life, psychological distress, fatigue and lifestyle habits. the current study will be conducted at the gastroenterology department of the university hospital of patras with the collaboration of the department of psychiatry. nafld patients will be invited to enrol to the study after being thoroughly informed about its aim and methods. eligible patients will be assessed at baseline and then will be randomized to receive either systematic counseling based on the principles of motivational interviewing or care as usual. all participants will be re-evaluated at 6 months after study initiation. in addition, all patients will be submitted to laboratory tests including complete blood count, serum albumin, hemoglobin, gamma-globulin, alt, ast, γgt, alp, bilirubin, pt, inr, urea, creatinine, total cholesterol, ldl, hdl, triglycerides both at baseline and at study completion

Eligibility criteria:
inclusion criteria: • non-alcoholic fatty liver disease according to the easl-easd-easo clinical practice guidelines for the management of non-alcoholic fatty liver disease exclusion criteria: * chronic viral hepatitis or any other severe chronic liver disease * major psychopathology * severe cognitive or neurological deficits * cancer or any other severe chronic disease not associated with nafld * inadequate knowledge of the greek language
helping people to exercise regularly

Conditions: Obesity; Heart Disease

Summary: this study tests two different incentive mechanisms to induce members of a particular urban senior center to attend more exercise classes. coupons for future use are given to participants who attend an exercise class and will be redeemable within either a one week or three month time period, depending on which experimental group the participant is assigned to. frequency of exercise class attendance at the end of 2 months will be the primary outcome.


Eligibility criteria:
inclusion criteria: * age 55 years or older * member of the philadelphia senior center exclusion criteria: * none

Keywords: obesity heart disease seniors elderly chronic disease prevention
a study of telitacicept for the treatment of generalized myasthenia gravis (rememg)

Conditions: Generalized Myasthenia Gravis

Summary: the purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of generalized myasthenia gravis.

myasthenia gravis (mg) is an autoimmune disease that affects the neuromuscular junction on the postsynaptic membrane. the predominant manifestation is muscle weakness, which typically worsens with repeated muscle exertion, such that function is usually the best in the morning with more pronounced weakness at the end of the day. a major challenge in mg is the lack of therapies that cure the disease. telitacicept is a fully human taci-fc fusion protein that targets b-lymphocyte stimulator (blys) and a proliferating-inducing ligand (april), neutralizing their interactions with receptors on b cells. the blockage of blys and april interaction with their respective cell membrane receptors (transmembrane activator and caml interactor \[taci\], b-cell maturation antigen, and blys receptors) by telitacicept would inhibit b-cell proliferation and maturation. this suppression at the proximal portion of the immune response could alleviate autoimmune symptoms. this study is a randomized, double-blind, placebo-controlled phase 3 study with an open-label extension to evaluate the efficacy and safety of telitacicept in a global patient population with gmg.

Eligibility criteria:
key inclusion criteria: 1. male or female patient aged ≥18 years at screening. 2. patients have prior confirmed diagnosis of gmg with generalized muscle weakness (typical pattern of weakness meeting the clinical criteria for diagnosis of mg as defined by the myasthenia gravis foundation of america (mgfa) clinical classification ii-iv. 3. patients have positive antibodies against achr or musk at screening. 4. mg-adl score ≥6 points at screening and baseline with ocular-related score \<50% of the total score. 5. qmg score ≥11 points at screening and baseline. key exclusion criteria: 1. patients have been diagnosed with any other autoimmune disease. 2. patients having acute or chronic infection. 3. patients having thymoma within 5 years or received thymectomy ≤6 months prior to screening. 4. patients having current or history of primary immunodeficiency. 5. patients having history of malignancy within the last 5 years. 6. patient having prior or continuing diagnosis of serious cardiovascular disease.

Keywords: myasthenia gravis gmg
bioequivalency study of ibuprofen 200 mg and pseudoephedrine hcl 30 mg tablets of dr. reddy's under fasting conditions

Conditions: Healthy

Summary: the purpose of this study is to assess the bioequivalence of ibuprofen 200 mg + pseudoephedrine hcl 30 mg under fasting conditions.

this study assess the bioequivalence of ibuprofen 200 mg + pseudoephedrine hcl 30 mg tablets of dr. reddy's and advil® cold and sinus caplets of wyeth consumer healthcare in healthy human adult subjects with the single oral administration under fasting conditions with a washout period of 7 days.

Eligibility criteria:
inclusion criteria: * healthy human subjects between 18-50 years of age (inclusive), weighing as per the standard height and weight chart of life insurance corporation of india (ii underweight and overweight min. \& max. chart) * subjects who have no evidence of underlying disease during screening medical history and whose physical examination is performed within 21 days to commencement of the study. * subjects whose screening laboratory values are within normal limits or considered by the physician/principal investigator to be of no clinical significance. * informed consent given in written form according to section 10.3 of the protocol. * female subjects: 1. of child bearing potential practicing an acceptable method of birth control for the duration of study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (iud), or abstinence. 2. postmenopausal for at least 1 year. 3. surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject. exclusion criteria: 1. history or presence of significant: * cardiovascular, pulmonary, hepatic, renal hematological; gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease. * alcohol dependence, alcohol abuse or drug abuse within past one year. * moderate to heavy smoking (\> 10 cigarettes/day) or on assumption of tobacco products. * history of difficulty in swallowing. * clinically significant illness within 4 weeks before the start of the study * asthma, urticaria or other allergic type reactions after taking any medication. 2. subjects who, through completion of the study, would have donated in excess of: * 500ml of blood in 14 days, or * 500 - 800 m l of blood in 14 days (unless approved by the principal investigator) * 1000 ml of blood in 90 days * 1250 ml of blood in 120 days * 1500 ml of blood in 180 days * 2000 ml of blood in 270 days * 2500 ml of blood in 1 year 3. participation in another clinical trial within the preceding 28 days of study start. 4. subjects who have: * systolic blood pressure less than 90 mm of hg and more than 150 mm of hg * diastolic blood pressure less than 60 m of hg and more than 95 mm of hg. minor deviations (1-3 mm hg) at check-in may be acceptable at the discretion of the physician/investigator * pulse rate below 50/min. and above 105/min. 5. female volunteers demonstrating a positive pregnancy screen or currently breast-feeding.

Keywords: bioequivalence crossover ibuprofen and pseudoephedrine
study of perifosine + capecitabine for colon cancer patients

Conditions: Colon Cancer

Summary: this is a phase i study of perifosine + capecitabine for patients with advanced colon cancer.

this study is a phase i trial. a total of 3 - 9 patients will be enrolled. three patients will initially be enrolled. there will be no dose escalation in this study as only one dose for perifosine (50 mg) in combination with one dose of capecitabine (1000 mg/m2 bid) will be evaluated. the maximum tolerated dose (mtd) is defined in which fewer than 33% of patients experienced dlt attributable to the study drug(s), when at least six patients have been treated at that dose and are evaluable for toxicity. pharmacokinetic (pk) data will also be evaluated from all enrolled patients.

Eligibility criteria:
inclusion criteria: * patients with 3rd line or \> metastatic colon cancer * patients must have received or not be candidates for regimens containing 5- fu, oxaliplatin, irinotecan, bevacizumab, and cetuximab or panitumumab * no prior exposure to perifosine * adequate bone marrow, liver, and renal function * patients must have at least one measurable lesion * patients must agree to have extra blood drawn for pk analyses exclusion criteria: * patients with prior exposure to perifosine. * patients receiving any other investigational agents or devices. * history of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine). * patients with known dipyrimidine dehydrogenase (dpd) deficiency or prior severe reaction to 5-fu. * patients with known central nervous system cns metastases. * patients with known hiv, hepatitis b, or hepatitis c seropositivity. * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection and psychiatric illness/social situations that would limit compliance with study requirements. * patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment), or new york heart association class ii-iv congestive heart failure. * female patients who are pregnant or lactating are ineligible.

Keywords: perifosine capecitabine colon cancer
a study to evaluate the safety of flumist in healthy children and healthy adults

Conditions: Healthy

Summary: the purpose of this study was to expand the data describing the safety profile of flumist in the indicated populations (5-8, 9-17, and 18-49 years of age) and to assess the safety of annual revaccination in those who received flumist in 2 or more consecutive years.

the primary objective of this study was to assess the safety of flumist vaccination by comparing the rates of medically attended events (maes) (including serious adverse events \[saes\], anaphylaxis, urticaria, asthma, wheezing, pre-specified grouped diagnoses, and rare events potentially related to wild-type influenza) in flumist recipients to rates in multiple non-randomized control groups.

Eligibility criteria:
inclusion criteria: * 5-49 years of age * members of the kaiser permanente (kp) health care plan within kp of northern california, kp of colorado, and kp of hawaii exclusion criteria: * must not have had any high risk underlying medical conditions, includig asthma
determination of analgesic effect from one transcranial magnetic stimulation(tms)treatment following vaginal reconstructive surgery.

Conditions: Pain

Summary: to determine whether real tms is more effective than sham tms in reducing pain following surgery

to determine the amount of opiate and pain medication administered in the week following surgery. subjects will receive an identical pain control regimen. participants will undergo tms motor threshold assessment at the etsu innovation lab prior to the planned surgery. at this appointment a baseline beck depression inventory (bdi), center for epidemiological studies 10-item depression scale (ces-d) and visual analog scale (vas) ratings of pain and mood will be obtained.vas ratings will also be done each evening over the following week. one day after surgery, the subject will return to the innovation lab for tms. a total of 22 subjects will be recruited for the study. at the return visit, 11 will receive 40 minutes of 10 hz repetitive tms at 120% of rmt (4-second stimulation trains with 26-second interstimulus intervals). the other 11 participants will receive sham treatment under identical settings. participants, medical staff providing clinical care to patients and raters will not know whether participants receive real or sham tms. patients will keep a log of pain medications used over the following week in addition to the vas ratings. follow-up will occur one week after the tms therapy. the subject will turn in logs and repeat bdi and ces-d scales.

Eligibility criteria:
inclusion criteria: dental fillings, implants, and bridge work are permitted. - exclusion criteria: metal objects within 30 cm of the brain. these include cochlear implants, stents, vagus nerve stimulators, heart devices, bullet fragments, or jewelry. monitors, earrings, hearing aids, eyeglasses, jewelry, hair barrettes, cell phones, and digital sound recording device players will be removed. actively suicidal. older than 70 years. seizures, strokes, dementia, or movement disorders. pregnant or nursing. permanent makeup with metal ink. medication known to increase risk of seizures. -
early warning system

Conditions: Congestive Heart Failure; Chronic Obstructive Pulmonary Disease; Cancer; Diabetes Mellitus; Obstructive Sleep Apnea

Summary: the study will begin in 2013 whereby patients having an early warning system (ews) alert will be randomized to be seen by the rapid response team (rrt) for triage versus usual care. a rrt is usually made up of a nurse and/or a physician who respond to a requested activation of the rrt (called an "act"). the intervention will occur as follows:

the study will begin in 2013 whereby patients having an early warning system (ews) alert will be randomized to be seen by the rapid response team (rrt) for triage versus usual care. a rrt is usually made up of a nurse and/or a physician who respond to a requested activation of the rrt (called an "act"). the intervention will occur as follows: 1. real-time monitoring of the eight general hospital wards (ghws)((10100, 10200, 11100,11200, 12100, 12200, 14400, 14500)will occur 24 hours daily. through multiple past collaborative efforts and studies involving interventions at bjh, informatics personnel have already demonstrated that they can accomplish this task using their computing and algorithmic resources. the prediction tool (pt) employed is a validated pt aimed at identifying any form of clinical deterioration occurring on a ghw requiring icu transfer or leading to patient death. 2. patients meeting the prediction criteria for an increased risk of clinical deterioration will be identified on the ghws. an automated text message will be generated that provides the patient's name, their room number, the date and time of the message, and text indicating that they meet the criteria for risk of deterioration. messages will only be generated for patients assigned to the intervention group. 3. the ews text message will be sent to the on-call rrt nurse's phone. these are phones that are transferred from one rrt nurse to the other as changes of shift occur. it is their primary means of communicating with the hospital. 4. the rrt nurse for the intervention patients will go into the flagged patient's room within 10 to 15 minutes of receiving the message and perform a clinical assessment. based on the rrt nurse's assessment either no additional action need occur or he/she will call either the physician on duty or activate an act as well as apply the "four d's", which was internally established at barnes-jewish hospital (bjh) for treatment of patients on ghws identified to have impending clinical deterioration. the four "d's" refer to the following: discuss level of care, drugs for treatment (e.g., antibiotics), diagnostics (lab tests, cultures), and damage control (e.g., use of intravenous fluids, oxygen).

Eligibility criteria:
inclusion criteria: * patients hospitalized on the general hospitals wards of barnes-jewish hospital. exclusion criteria: * patients with a do-not-resuscitate order, * patients not expected to survive their hospitalization.

Keywords: outcomes early warning systems icu transfer
pediatric virtual visits as a strategy for access to care during the covid-19 pandemic in a pediatric hospital

Conditions: Telehealth

Summary: in this study we will describe the factors associated with missed virtual visit appointments in an academic children´s hospital during the covid-19 pandemic and we will develop a predictive model that serves as the basis for improving the telehealth program.

pediatric visits are a fundamental axis of health policies because actions to promote and protect health have a maximum effect on children. due to the covid-19 pandemic a marked decrease in pediatric visits was observed in scheduled and on-call visits. this fact can be explained by the restriction on people's circulation necessary to contain covid-19 dissemination. in this context, the population that attends the hospital general de niños pedro de elizalde was especially affected, since 91% of the patients attending the institution live in another district. in order to overcome this barrier in access to care, we decided to implement a telehealth program that uses virtual visits as a tool for access to care. little is known about the effects that these programs can have on patients with exclusive public health coverage. although virtual visits could be a solution for access to care in an oversaturated system, there is the possibility that virtual visits could not be carried out and that a significant proportion will be lost, increasing inequity and difficulties in access to health. due to the relevance of the topic and the little information available, we propose in this study to estimate the proportion of virtual visits appointments lost. on the other hand, considering the possibility of avoiding the loss of virtual visits appointments, we propose to describe the factors associated with missed appointments and develop a predictive model that serves as the basis for improving the telehealth program.

Eligibility criteria:
inclusion criteria: * all scheduled virtual visits exclusion criteria: * on-call virtual visits

Keywords: telehealth children covid-19 virtual visit lost appointments
effect of virtual reality training by novices on laparoscopic cholecystectomy in a porcine model

Conditions: Gallstones

Summary: this study proposes evaluation of an educational tool, a laparoscopic virtual reality simulator. the purpose of this study is to determine whether training on the lapsim simulator transfers to improved laparoscopic cholecystectomy operative performance in an animal model.

this is study protocol involves the training and evaluation of general surgery interns on a laparoscopic simulator (lapsim®, surgical science ltd, göteborg, sweden, version 3.0.

Eligibility criteria:
inclusion criteria: * surgical interns (pgy 1) are eligible * twenty-five (25) participants will comprise this group exclusion criteria: * prior clinical experience with laparoscopic surgery as the assistant surgeon. * prior simulation training (mechanical, pc-based or otherwise).

Keywords: resident training laparoscopic skills surgical skills assessment