Kornimate/medical-research-clean huggingface dataset:
shared medical appointments for weight loss

Conditions: Obesity

Summary: randomized controlled trial to determine if a 6 months of shared medical appointments will results in clinically and statistically significant weight loss.

obese patients will be randomized to either the control or intervention group. the intervention group will participate in 90-minute group visits occurring weekly for 4 weeks, then biweekly for a total of 26 weeks/15 visits. each visit will focus on intensive lifestyle changes: calorie restriction to produce a 500-750 calorie deficit, increased physical activity, and behavioral therapies including regular self-monitoring of food intake, physical activity, and weight. additional behavioral therapies that will be offered include techniques for reducing stress, maximizing sleep, and controlling environments. further, these patients will each have the opportunity to meet one-on-one with a member of the research team at the end of each visit in order to discuss individual goals and progress.

Eligibility criteria:
inclusion criteria: * current patients of the usf family or general internal medicine clinics * bmi of 30 or greater * able to speak and read english exclusion criteria: * age over 75 years, patients with end-stage renal disease with estimated gfr less than 15 ml/min, diabetes mellitus with an a1c \> 9%, acute coronary syndrome (such as unstable angina, pacemaker or defibrillator due to impedance scale), recent history of weight loss (\>5% of body weight), pregnant or breastfeeding women, dementia or unstable psychiatric disorder, participation in any structured weight loss program currently or in the previous 3 months, cancer, or anyone unable to complete study protocol (exercise amounts, food intake).
improving mood and behavior in assisted living residents through skills training for their caregivers

Conditions: Dementia; Alzheimer Disease

Summary: this study will develop a treatment program to reduce mood and behavior problems in assisted living residents who have dementia.

assisted living is rapidly becoming one of the most common methods of caring for older adults with dementia in long-term care. over half of assisted living residents have dementia and many exhibit affective and behavioral problems related to the condition; residents' care and quality of life may suffer as a result of these problems. despite the seriousness of this condition, interventions to teach direct care staff how to care for these residents are limited. this study will develop a program for teaching assisted living staff how to deal with the issues of patients with dementia and reduce mood and behavioral problems among this population. caregivers will be randomly assigned to attend skills training sessions as two 4-hour workshops, four 30 minute individual training sessions, or two 30 minute in-services. training will focus on dementia, depression and anxiety, the incidence of behavior problems, and skills and techniques for alleviating care challenges associated with behavior problems. caregivers will complete self-report scales and questionnaires at the beginning and at the end of the study; these measures will assess job satisfaction, reactions to resident behavioral problems, and job skills. residents will also be recruited for this study; they will complete questionnaires about their depressive episodes, anxiety, behavioral problems, and quality of life at the beginning and at the end of the study.

Eligibility criteria:
inclusion criteria for assisted living staff * work in the assisted living residence for at least 6 months prior to study entry * work in the assisted living residence at least 5 days a week, for at least 4 hours a day on day or afternoon-evening shifts * provide direct care for at least 1 assisted living resident * agree to attend all training sessions and complete assessment forms * able to speak, read, and understand english at a 6th grade level inclusion criteria for assisted living residents: * diagnosis of dementia * identified by caregiving staff as having mood or behavioral problems * have lived at the assisted living residence for at least 3 months prior to study entry * have a family member with power of attorney exclusion criteria for assisted living residents: * plan to receive medication for affective or behavioral problems during the study * history of alcohol or drug abuse * have attempted suicide within 1 year prior to study entry

Keywords: assisted living facilities aged elderly caregivers
special investigation of genotropin long follow-up for patients with a small for gestational age "scoped for japanese"

Conditions: Small for Gestational Age (SGA)

Summary: the objective of this surveillance is to collect safety and effectiveness information for long term use of somatropin for patients with a small for gestational age (sga).

all the patients whom an investigator prescribes genotropin should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility criteria:
inclusion criteria: * a patient who was administered somatropin (genotropin). exclusion criteria: * n/a.

Keywords: genotropin somatropin long term follow-up special investigation small for gestational age sga
study in japan of the safety and antiviral activity in adults with chronic hepatitis b current lamivudine therapy

Conditions: Chronic Hepatitis B

Summary: the objectives are to demonstrate that entecavir has antiviral activity undetectable hbv dna measured, the roche amplicortm pcr at week 48, and to assess the safety and the pharmacokinetic of entecavir in japanese patients with hepatitis b who have an incomplete response to current lamivudine therapy


Eligibility criteria:
inclusion criteria: * documentation of chronic hepatitis b infection by all of the following: 1. positive for hbsag or, negative for igm core antibody and confirmation of chronic hepatitis b on liver biopsy 2. patient who have received lamivudine therapy for 24 weeks or more, or patient who have documented ymdd mutation or other lamivudine-resistant mutation while on lamivudine 3. documented hbv viremia ≥ 10\*5: copies/ml * alt in the range of 1.3 to 10 x uln * subjects must have well-compensated liver disease a) value exclusion criteria: -
diet, physical activity and glucose tolerance in cystic fibrosis. exploratory study.

Conditions: Cystic Fibrosis

Summary: background : diabetes is correlated to an increase in patient morbidity and mortality. the pathophysiology of diabetes is still poorly understood. significant variations in blood sugar have been shown over time in patients with cystic fibrosis with or without diabetes. no study has evaluated the association between the nutritional profile and the glucose tolerance in adult with cystic fibrosis, by integrating data on energy consumption (detailed nutritional profile) and energy expenditure (rest energy expenditure, body composition, and physical activity). given the epidemiological changes in cystic fibrosis correlated to the increased prevalence of diabetes and the clinical impact of nutritional status, the association between these factors remains to be studied. objectives of the study : - main objective : to describe adult patients with cystic fibrosis in terms of : * nutritional profile * food behaviour * physical activity * rest energy expenditure * body composition - secondary objectives : to research the association between the nutritional profile and the glucose tolerance.

study design : the study will last 12 months. it's an observational cross-sectional study; patients are include during a scheduled review at the cystic fibrosis resource and competence centre (crcm de lyon) and their participation lasts only one day. the inclusion period will last 12 months. expected results the expected results are: * identify the inter-relationships between nutritional profile and glucose tolerance in adult patients with cystic fibrosis * describe the body composition and consumption on resting energy of adults with cystic fibrosis the perspectives are: * propose nutritional and dietetic measures to limit the deterioration of the glucose tolerance in adult patients with cystic fibrosis * develop equations for evaluating consumption on resting energy specific to adult patients with cystic fibrosis in order to more specifically adapt the nutritional recommendations to each patient the research perspectives are to compare adult patients with cystic fibrosis followed in france and quebec in terms of: * nutritional profiles, nutritional quality index of food and eating behaviours, resting energy expenditure, body composition * nutritional medical practices (dietary monitoring, recommendations given to patients, intake of pancreatic enzyme).

Eligibility criteria:
inclusion criteria: * patient (male or female) with cystic fibrosis aged 18 years and over * pancreatic insufficiency * followed at the crcm adult in lyon * patient able to understand the information given to him * patient having previously had a medical examination during the selection visit exclusion criteria: * fev \< 30% * lung transplant * patient treated with insulin * parenteral feeding on nasogastric tube or gastrostomy * patient under guardianship or protected by law * patient deprived of his liberty by judicial or administrative decision * patient currently in an another clinical study
preventing recurrent bleeding after eradication of esophageal varices

Conditions: Esophageal Varices

Summary: esophageal variceal bleeding is a severe complication of portal hypertension. banding ligation plus non-selective beta-blockers is the current recommendation for prevention of recurrent bleeding. however, the optimal duration of use of non-selective beta-blockers is not well defined. this study aims at comparing the rebleeding rate and adverse effects in patients using or without using propranolol after eradication of esophageal varices.

cirrhotic patients with acute or recent esophageal variceal bleeding undergo banding ligation at 1-month interval until eradication of esophageal varices. patients start propranolol (start with 30 mg daily) at 6th day after control of acute bleeding till eradication of esophageal varices, aiming at decreasing pulse rate to 25% or to 55 bpm while systolic pressure is above 85 mmhg. patients randomized to propranolol group continue propranolol after eradication of esophageal varices. patients randomized to banding ligation group discontinue propranolol after eradication of esophageal varices. patients are followed to evaluate the incidence of rebleeding, adverse effects and survival.

Eligibility criteria:
inclusion criteria: * age of 20 to 80 years * cirrhotic patients with acute or recent esophageal variceal bleeding proven by an endoscopy * stable hemodynamic condition for at least 3 days after banding ligation exclusion criteria: * hepatocellular carcinoma or other malignancy * stroke or active sepsis * chronic kidney disease under renal replacement therapy * contraindications to non-selective beta-blockers * a history of non-selective beta-blockers use, sclerotherapy, banding ligation, transjugular intrahepatic porto-systemic shunt, or shunt surgery * serum total bilirubin \>10 mg/dl * grade iii/iv hepatic encephalopathy * refractory ascites * hepato-renal syndrome * pregnancy * severe heart failure (nyha fc iii/iv) * bronchial asthma or chronic obstructive pulmonary disease * second or third degree atrioventricular block * sick sinus syndrome * pacemaker use * severe hypotension * refusal to participate

Keywords: esophageal varices; propranolol; banding ligation
the utility of pretracheal stethoscope in detecting respiratory abnormalities in sedated children

Conditions: Sedation

Summary: the purpose of the study is to validate the diagnostic performance of the amplified pretracheal stethoscope (aps) to detect sedation-related adverse acute respiratory events in propofol sedated nonintubated children. to determine the sensitivity/specificity and positive/negative predictive value of the aps in detecting sedation-related adverse acute respiratory events in propofol sedated nonintubated children.


Eligibility criteria:
inclusion criteria: * patients 2 years to 18 years of age undergoing induction and maintenance of propofol sedation at the american family children's hospital (afch) pediatric sedation clinic * american society of anesthesiology score (asa) of 1-2 exclusion criteria: * asa scoring \> 3 * oxygen requirement and cardiorespiratory instability * allergy to propofol or its components * patients requiring propofol sedation outside the afch pediatric sedation clinic

Keywords: propofol sedation children procedure sedation
european trial into mpox infection

Conditions: Monkeypox

Summary: the goal of this randomized controlled double-blind clinical trial is to test the drug tecovirimat in patients with mpox (previously known as monkeypox) disease. the main questions it aims to answer are: * is tecovirimat effective in treating mpox infection. * is tecovirimat safe to treat patients with mpox infection. participants will receive either the drug tecovirimat orally, 600 mg twice per day, or a matching placebo. the outcome of the infection and the side effect experienced will be compared between the two groups.


Eligibility criteria:
inclusion criteria: * polymerase chain reaction (pcr) /nucleic acid amplification test (naat) -confirmed mpox infection * the presence of active skin or mucosal lesion(s) * signed informed consent form exclusion criteria: * age \<18 years. * body weight \<40 kg * pregnant and breastfeeding patients are not eligible for inclusion in this study. * lack of mental capacity to provide informed consent * trial participation is considered not in the best interest of patient * known hypersensitivity to the active substance or to any of the excipients of the study drug. * use of contraindicated treatment repaglinide. (repaglinide, an oral treatment for diabetes mellitus, may be discontinued while taking study treatment with the agreement of the patient's general practitioner, who may start alternate diabetes treatment if considered necessary.) * previous, current or planned use of another investigational drug (tecovirimat) at any point during study participation. * the patient's own doctor considers there to be a definite indication for the patient to receive tecovirimat or the local guidelines establish that tecovirimat treatment should be initiated * the patient's own doctor considers there to be a definite contraindication to the patient receiving tecovirimat. * the patient suffers from hereditary problems of galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption.

Keywords: tecovirimat mpox tpoxx
individual patient compassionate use of mirdametinib

Conditions: Neurofibromatosis Type 1-Associated Plexiform Neurofibromas; Histiocytic Neoplasm; Other MAP-K Pathway Driven Diseases

Summary: this program is being offered on a patient by patient basis and will require company, institutional review board/independent ethics committee, and applicable competent authority approval.


Eligibility criteria:
inclusion criteria: * patient has a serious, debilitating or life-threatening medical condition that cannot be treated satisfactorily with an authorized medicinal product or other available standard treatment options, or all other treatment options have been exhausted. * patient does not qualify to participate in an ongoing clinical trial.

Keywords: rasopathies nf1 neurofibromatosis plexiform neurofibromas langerhans
feasibility of etco₂ changes during passive leg raise for fluid management in lung surgery

Conditions: Lung Cancer

Summary: aim: end tidal carbondioxide pressure (etco2) is an indirect indicator of cardiac output (co) which is monitored in every patient at perioperative setting. the investigators aimed to use increase of etco2 as a response to passive leg raising maneuver (plr) to indicate fluid responsiveness in patients who underwent lung resection with video-assisted thoracoscopic surgery (vats).

materials and methods: 50 patients included who are eligible according to inclusion criteria of the study who underwent lung resection operation via vats between agust 2020-march 2021. after a standardized anesthesia induction protocol and intubation, plr is applied to all patients as soon as anesthesia depth and ventilation stabilized. an increase of 2 mmhg at etco2 at first minute of plr evaluated as "fluid responsive" due to an increase of venous return. responsive patients divided into two groups as "study" and "control" when unresponsive patiens inclueded into "unresponsive" group. patients at study group received a fluid bolus (250 ml (and an additional 250 ml if mean arterial pressure remained below 65 mmhg )) in addition to maintainence fluid as control group and unresponsive group received only maintainence fluid. hemodynamic data, surgery duration, total iv fluid administration, use of blood products, bleeding and urine output during surgery of all patients recorded. preopretive and postoperative urea, creatinine and lactate levels of all patiens compared. total iv fluid administration and urine output recorded during postoperative 24 hours.

Eligibility criteria:
inclusion criteria: * patients undergoing lung resection surgery via vats * asa i-ii-iii * patients older than 18 years exclusion criteria: * asa iv or more * post operative icu stay * resections greater than lobectomy * history of renal and heart failure * patients younger than 18 years.
neoviderm skin emulsion in the prevention of radiation dermatitis

Conditions: Head and Neck Cancer; Breast Cancer

Summary: the purpose of this study is to determine whether neoviderm is effective at preventing radiation dermatitis in patients receiving external beam radiation therapy to the head and neck or breast areas.


Eligibility criteria:
inclusion criteria: for patients receiving radiation to the breast 1. patients receiving a dose of at least 50 gy in 25 fractions with concomitant chemotherapy or treated with the mcgill technique. 2. patients able to understand and sign an informed consent form. 3. patients that do not have active connective tissue disorders. 4. patients 18 years or older. 5. patients that did not receive any previous radiation. 6. patients that do not have any known allergy to any ingredients of the neoviderm cream 7. patients need to be able to apply the creams themselves or have help with applying the creams. inclusion criteria: for patients receiving radiation to the head and neck 1. patients receiving radiotherapy on fields that include both sides of the neck 2. patients able to understand and sign an informed consent form. 3. patients that do not have active connective tissue disorders. 4. patients 18 years or older. 5. patients that did not receive any previous radiation. 6. patients that do not have any known allergy to any ingredients of the neoviderm cream 7. patients need to be able to apply the creams themselves or have help with applying the creams. exclusion criteria: for patients receiving radiation to the breast or the head and neck 1. patients that have a type v or type vi skin type according to the fitzpatrick scale (because these patients will likely have less radiodermatitis and if they do, it will be harder to evaluate it). the fitzpatrick scale: * type i (scores 0-7) white; very fair; freckles. always burns, never tans * type ii (scores 8-16) white; fair. usually burns, tans with difficulty * type iii (scores 17-25) beige; very common. sometimes mild burn, gradually tans * type iv (scores 25-30) beige with a brown tint; typical mediterranean caucasian skin. rarely burns, tans with ease * type v (scores over 30) dark brown. very rarely burns, tans very easily * type vi black. never burns, tans very easily 2. allergic to any ingredient in neoviderm cream

Keywords: patients with
palliative care in pulmonary fibrosis

Conditions: Idiophatic Pulmonary Fibrosis

Summary: the investigators will examine the effect of introducing palliative in patients with end-stage idiopathic pulmonary fibrosis, refractory to the pharmacological treatment or not deemed to be treated, on patient-reported outcomes and end-of-life care. the investigators will randomly assign patients who receive either early palliative care integrated with standard respiratory care or standard respiratory care alone. quality of life and symptoms will assessed at baseline and at 12 weeks the primary outcome will be the change in the quality of life and symptoms at 12 months.

advanced fibrosing interstitial lung disease (ild) is a group of often progressive and incurable conditions. the most common form of ild, idiopathic pulmonary fibrosis (ipf), is associated with poor survival, and high symptom burden and poor quality of life as the disease progresses. ild represents an increasing proportion of patients with chronic hypoxemic respiratory failure. despite this poor prognosis, palliative care remains underused in patients with ild. this may be due to under-recognition of the palliative care needs and symptom burden, or unfamiliarity and discomfort with palliative therapies. though oncology has largely embraced earlier integration of palliative care, which has translated into improvements in end-of-life (eol) care for patients with lung cancer,palliative and eol care for non-malignant diseases are now gaining increased attention. in pulmonary disease, this research has mainly focused on copd and demonstrated a significant burden of unmet palliative care needs and lower quality of eol care compared with patients with cancer. similar attention is only beginning to be paid to ild, but symptom burden and quality of eol care in patients with ild have yet to be quantified, and furthermore none has so far investigated the possible role of palliative care in these patients. the investigators will examine with the present study the effect of introducing palliative in patients with end-stage idiopathic pulmonary fibrosis, refractory to the pharmacological treatment or not deemed to be treated, on patient-reported outcomes and end-of-life care. the investigators will randomly assign patients who receive either early palliative care integrated with standard respiratory care or standard respiratory care alone. quality of life and symptoms will assessed at baseline and at 12 weeks the primary outcome will be the change in the quality of life and symptoms at 12 months.

Eligibility criteria:
inclusion criteria: * diagnosis of idiophatic pulmonary fibrosis * resting partial arterial oxygen pressure (pao2) \< 60 mmhg * decline in forced vital capacity (fvc) \> 10% in the last 6 months * stage 3 according to the gap index exclusion criteria: * active treatment with antifibrotic drug * concomitant cancer