Kornimate/medical-research-clean huggingface dataset:
pku easy microtabs plus - acceptability and tolerance

Conditions: Phenylketonuria (PKU)

Summary: pemp-at is a prospective, single-arm, open-label, 1-week acceptability study to evaluate pku easy microtabs plus for the dietary management of participants with phenylketonuria (pku). up to 10 participants aged 3 years and above will be recruited in a single-centre in the uk.

pku is a rare inborn error of metabolism with a prevalence of 1 in 10,000 in the uk population. the mainstay of treatment for most individuals is dietary therapy with a strict protein-restricted diet. we propose to recruit children with a diagnosis of pku aged 3 years and above. the study product, pku easy microtabs plus is a food for special medical purposes (fsmp), as defined by the delegated act eu 2016/128, used for the dietary management of phenylketonuria (pku). the study will be investigating the acceptability of pku easy microtabs plus, as defined by the advisory committee on borderline substances (acbs). this includes the following: participant adherence to recommended intakes gastrointestinal symptoms evaluations of palatability. each participant will be on the study for 1 week. the study consists of a 1 week period where participants introduce the study product into their diet. gastrointestinal tolerance, compliance and product acceptability will be evaluated. data collection will be performed using paper data collection forms completed by the investigators at the baseline and end of study visits. patients/parents/guardians, as appropriate, will also complete a brief daily questionnaire on each of the 7 study days. there will also be a questionnaire completed by the patient/parents/guardians over the course of the study, in relation to protein substitute intake, gastrointestinal tolerance, and product acceptability.

Eligibility criteria:
inclusion criteria: * diagnosis of pku requiring an appropriate protein substitute * subjects who are already taking an appropriate protein substitute and are willing to try the study product for 7 days * subjects aged 3 years and above * written informed consent obtained from subject or parent/legal guardian, depending on subject age exclusion criteria: * presence of serious concurrent illness * lead dietitian's uncertainty about the willingness or ability of the patient to comply with the protocol requirements * participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study, with the exception of sapropterin * any subject having taken antibiotics over the previous 2 weeks leading up to the study * subjects less than 3 years of age

Keywords: pku microtabs protein substitute amino acid
comminuted fractures of the midshaft of the tibia; (interlocking nail +/- blocking screws or locked plating with predicted distribution of locking screws) choice based on finite element analysis correlated with clinical outcome and union.

Conditions: Comminuted Fracture Tibia

Summary: study is to assess the clinical and radiological results of comminuted fractures of the midshaft of the tibia; treated with interlocking nail +/- blocking screws or locked plating with predicted distribution of locking screws, choice based on finite element analysis correlated with clinical outcome and union.

fe analyses will be performed using the finite element code cosmos/m. the three-dimensional "lower leg" fe model (ll fe model) will be used included the tibia and the fibula. the bony structures will be generated by segmentation of a data set of computed tomographies from the visible human project. analysis of data regarding clinical outcomes and radiological assessment of healing rate and union

Eligibility criteria:
inclusion criteria: 1. patients with closed comminuted fractures of the midshaft of the tibia 2. patients with age ranging from 25 to 45 years old exclusion criteria: * 1- simple fractures of the midshaft of the tibia. 2- patients with open comminuted fractures of the midshaft of the tibia. 3- critical and icu patients. 4- patients with ipsilateral lower limb fractures.

Keywords: comminuted fracture, finite element analysis, tibia
opportunistic salpingectomy in non-gynecological surgeries

Conditions: Ovarian Cancer Prevention

Summary: the goal of this study is to evaluate patient's compliance for opportunistic salpingectomy (os) and procedure feasibility in non gynecological abdominal surgeries

patients who are candidate for non-gynecological abdominal surgery, are offered os. if agree, a general surgeon perform the procedure during the planned abdominal surgery

Eligibility criteria:
inclusion criteria: * women who were candidates for non-gynecological abdominal surgery * aged 45 or older, or aged 40 or older with a desire for bilateral salpingectomy exclusion criteria: * pregnant women * candidates for urgent surgery
biomarkers for early detection of lung cancer in patients with lung cancer, participants at high-risk for developing lung cancer, or healthy volunteers

Conditions: Lung Cancer; Tobacco Use Disorder

Summary: rationale: collecting and storing samples of sputum and tissue to study in the laboratory may help doctors identify biomarkers related to cancer. purpose: this research study is looking samples of sputum and tissue from lung cancer patients, participants at high risk for developing lung cancer, and from healthy volunteers (both smokers and non-smokers).

objectives: * to test and make a preliminary assessment of the sensitivity and specificity of fourier transform infrared technology (ftir) for use in the early detection of lung cancer in sputum samples from patients who have or participants at high risk for developing lung cancer and from non-high-risk smoking and non-smoking volunteers. * to permit identification of specific metabolic biomarkers within ftir spectra that can distinguish between lung cancer, high-risk, and non-high-risk cases. outline: this is a multicenter study. sputum samples and endobronchial biopsy tissue specimens are collected prior to routine bronchoscopy as part of a standard clinical assessment for the early detection of lung cancer. sputum samples are examined for levels of bronchial and non-bronchial cells using established cytological and immunohistochemical procedures. samples are also examined for metabolic biomarkers using fourier transform infrared spectroscopy (ftir) to generate complete metabolic fingerprints (i.e., spectra) that can distinguish metabolic differences between cancer, non-cancer, and early disease (i.e., dysplasia or metaplasia). these molecular biomarkers, which are detected within ftir spectra, may be further analyzed in matched endobronchial biopsy tissue samples for histological confirmation. additional clinico-pathological data is collected for each participant to allow development of predictive statistical models from the data. all study participants are followed annually.

Eligibility criteria:
disease characteristics: * meets 1 of the following criteria: * diagnosis of lung cancer * at high risk for developing lung cancer * non-high-risk smoking or non-smoking volunteer (control) patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: lung cancer tobacco use disorder
food choices in healthy weight women

Conditions: Addictive Behavior; Food Preferences; Food Habits; Healthy; Habituation

Summary: this study will examine differences in habituation to foods high in sugar and fat content versus those that are not, in normal weight women.

participants will complete two experimental sessions, in which habituation to chocolate cake and dried apricots will be measured, with each session measuring habituation rate to one food. upon arrival to the session, participants will write down what they have consumed and the minutes of physical activity they have engaged in during the previous 24 hours. participants will rate their feelings of hunger and fullness using a 100mm vas. they will also rank their liking of the food being used in the session using a 100mm vas. participants will be given a peanut butter flavored granola bar, containing 190 kcal, and be instructed to consume all of the bar. next, participants will complete a computer generated task to measure habituation to a food (chocolate cake or apricots). the computer task will be programmed at a variable interval of 120 ± 42 seconds (vi-120) reinforcement schedule, so that participants will be rewarded one point for the first response made after approximately 120s have passed. the computer task consists of two squares, one that flashes red every time a mouse button is pressed and another square that flashes green when a point is earned. the habituation phase will be 24 minutes, divided into 12, 2-minute trials, during which participants can earn points towards access to 75 kcal portions of the food that is being measured. participants will receive the food immediately after each point is earned to consume and can continue to play the computer task while eating. participants will be instructed that when they no longer want to earn access to the food they can go to another table and engage in the activities provided (i.e., reading magazines). after the computer task, participants will rate their feeling of hunger, fullness, and liking of the food. during the computer task the number of consecutive two-minute time blocks before responding ceases, as well as the overall pattern of responding, will be measured.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) 18.5 to 24.9 kg/m2 * nonsmokers * not allergic to the foods used in the investigation * must like the foods in the investigation (scoring \> 50 mm on a visual analogue scale \[vas\]) * be willing to consume the foods * not have dietary restrictions * not be a restrained eater (scoring \> 12 on the three factor eating scale) * not be on medications that influence appetite * not planning to change their diet or physical activity during the time frame of their study participation * not dieting or trying to lose weight. exclusion criteria: * bmi outside of the range 18.5-24.9 * smoker * food allergies * does not like the foods used in the study * has dietary restrictions * is a restrained eater * on medications that may influence appetite * planning on changing diet or physical activity during time frame of the study * dieting * trying to lose weight
impact of continuous non-invasive blood pressure monitoring on hypotension in patients having non-cardiac surgery

Conditions: Blood Pressure; Perioperative Hypotension

Summary: this is a randomized trial (1) investigating whether continuous non-invasive finger-cuff blood pressure monitoring reduces the area under a mean arterial pressure (map) of 65 mmhg within the first 15 minutes of anesthetic induction compared to intermittent blood pressure monitoring using upper-arm cuff oscillometry in patients having non-cardiac surgery; and (2) investigating whether continuous non-invasive finger-cuff blood pressure monitoring reduces the time-weighted average for map \<65 mmhg during the intraoperative period compared to intermittent blood pressure monitoring using upper-arm cuff oscillometry in patients having non-cardiac surgery.

not provided

Eligibility criteria:
inclusion criteria: * patients at least 45 years of age scheduled for elective non-cardiac surgery with general anesthesia are eligible for study inclusion if blood pressure monitoring using intermittent upper-arm cuff oscillometry is planned. exclusion criteria: * emergency surgery, * pregnancy, * american society of anesthesiologists (asa) physical status classification v or vi, blood pressure differences between the right and left arm of more than 20 mmhg, intraoperative invasive blood pressure monitoring, heart rhythms other than sinus rhythm.
safety study of sd-101 (a novel c type toll-like receptor 9 (tlr9) agonist) for the treatment of chronic hepatitis c virus (hcv) infection

Conditions: Chronic Hepatitis C

Summary: to determine safety, tolerability, and preliminary efficacy of escalating doses of sd-101 alone and sd-101 plus ribavirin in subjects with chronic hepatitis c and no prior therapy.


Eligibility criteria:
inclusion criteria: * signed, written, informed consent * male or female subjects, 18 to 55 years of age. * subject must have chronic infection hcv, genotype 1. * serum hcv-rna concentrations 100,000 iu/ml to 10,000,000 iu/ml * no prior treatment for hcv. * must be negative for hepatitis b (hbv) and human immunodeficiency virus (hiv). * must be willing to use dual method of contraception (i.e., barrier and spermicide; birth control pills and barrier) during the study. * no known hypersensitivity to study medication or to drugs chemically related to the study. exclusion criteria: * prior treatment with ifn-based therapies and/or anti-viral therapies. * women with ongoing pregnancy or breast feeding and male partners of women who are pregnant. * reduced kidney function. * presence of concomitant liver diseases * signs or symptoms of hepatocellular carcinoma. * thyroid disease currently poorly controlled on prescribed medications. * history of hemoglobinopathy. * evidence of severe retinopathy. * other serious medical conditions, including human immunodeficiency virus, cancer (excluding non-melanoma skin cancer), or evidence of drug or alcohol abuse. * subjects with documented or presumed coronary artery disease, pulmonary disease, or cerebrovascular disease * clinically significant acute or chronic illnesses. * history of severe psychiatric disease, especially depression, characterized by a suicide attempt, hospitalization for psychiatric disease, or a period of disability as a result of psychiatric disease.

Keywords: hcv immunostimulatory sequence (iss) tlr9 (toll-like receptor 9) interferon (ifn) ribavirin
prospective randomized comparison of bipolar hemiarthroplasty and total hip arthroplasty with large femoral heads for the treatment of displaced intracapsular femoral neck fractures in the elderly

Conditions: Femoral Neck Fractures

Summary: the purpose of this study is to compare hemiarthroplasty (hap) with total hip arthroplasty (tha), performed by trained arthroplasty surgeons with the use of large femoral heads for the treatment of displaced femoral neck fractures in mobile independent elderly patients, to determine the impact of these surgical options on the short term functional outcomes and complication rates, namely dislocation and the need for further surgery. this is a single-blinded prospective randomized clinical trial comparing functional outcome and complication rates of 40 patients treated with all cemented tha to a control group of 40 patients treated with cemented bipolar hap, in a 2 years followup. the primary endpoint is the oxford hip score (ohs) at last followup as a measure of functional outcome. secondary endpoints include the sf-36 score, walking distance and rates of postoperative dislocation, component loosening, need for revision and postoperative mortality.


Eligibility criteria:
inclusion criteria: * 1. acute femoral neck fracture. * 2. age between 70 and 90 years old. * 3. independent community ambulator (more than 0.5km, without the aid of another person. the use of a cane is permitted) prior to fracture. * 4. abbreviated mental test score \> 6 . exclusion criteria: * 1. pathological fracture (excluding osteoporosis). * 2. rheumatoid arthritis. * 3. symptomatic arthrosis of the involved hip. * 4. neurological disorder that may significantly influence walking ability and/or tendency to dislocate. * 5. chronic corticosteroid use. * 6. concomitant other fracture. * 7. very high surgical risk.

Keywords: femoral neck fractures hip fractures elderly total hip arthroplasty bipolar hemiarthroplasty
improving weight loss outcomes for binge eating disorder.

Conditions: Eating Disorder; Binge-Eating Disorder; Weight Loss; Binge Eating

Summary: this study aims to develop and evaluate the efficacy of a behavioral weight loss treatment approach for individuals with binge eating disorder to both reduce their binge eating behaviors and lose weight.

in the current study, we propose to (a) compare the efficacy of an acceptance-based behavioral treatment (abbt) that targets both binge eating and weight loss in patients with binge eating disorder (bed) to a standard behavioral weight loss treatment (sbt), (b) evaluate the extent to which abbt and sbt target shared maintenance factors for binge eating and overeating episodes, and (c) assess whether treatment efficacy is moderated by baseline values of constructs targeted in abbt. our study will be the first to evaluate an abbt for bed designed to 1) address maintenance factors that give rise to both binge eating episodes and overeating episodes without loss of control and 2) increase adherence to bwl prescriptions.

Eligibility criteria:
inclusion criteria: * meet the dsm-5 criteria for binge eating disorder * have a bmi range of 27-50kg/m2 exclusion criteria: * are unable to fluently speak, write, and read english * are currently experiencing severe psychopathology that would limit their ability to engage in study (e.g., suicidality, substance use disorder, psychotic disorder) * are unable to engage in moderate physical activity (i.e., walk 2 blocks without rest) * have a medical condition (e.g., acute coronary syndrome, type i diabetes) that would pose a risk to the participant during intervention, cause a change in weight, or limit ability to comply with the recommendations of the program * pregnant or planning to become pregnant in the next 2 years * recently began a course of or changed the dosage of medication that can cause significant change in weight * have a history of bariatric surgery * have had weight loss of \> 5% in the past 6 months

Keywords: eating disorder binge eating binge eating disorder weight loss
stroke volume optimisation in patients with hip fracture

Conditions: Hip Fractures

Summary: the aim of this study is to assess whether intra-operative fluid supplementation (to improve tissue perfusion) can reduce the incidence of postoperative complications in elderly patients with hip fracture.

rationale : hip fracture patients frequently develop postoperative complications that increase their hospital length of stay and the cost of care. these complications are also associated with increased mortality. perioperative tissue hypoperfusion may participate in the development of postoperative complications. hypovolemia is secondary to many factors in hip fracture patients (including blood loss, fasting and dehydration) and can result in low cardiac output and tissue hypoperfusion. two single-center, randomized, double-blind studies have demonstrated that peroperative fluid titration guided by esophageal doppler measurements of stroke volume could improve patient outcome. interpretation of these results was that such a stroke volume "optimisation" strategy could help the anesthesiologist give more fluids to his patient and reduce the risk of hypoperfusion without the risk of congestion, thereby reducing postoperative complications and improving patient outcome. we want to test the same hypothesis in a multicenter trial to confirm with a high level of proof the usefulness of this strategy. if previous results are confirmed, this could lead to a change in current anesthetic management of hip fracture patients and potentially have a very important economical impact on health costs.goals : primary endpoint is to demonstrate that colloid (voluven®) titration, guided using esophageal doppler estimation of stroke volume, during the surgical repair of hip fracture reduces the incidence of postoperative complications (composite criteria). secondary endpoints in the "optimised group" include : 1) reduced delay to walk without help ; 2) increased number of days " out-of-hospital " at 3 months after the fracture ; and 3) reduced 1-year mortality.

Eligibility criteria:
inclusion criteria: * elderly subjects (≥ 70 year old) with hip fracture exclusion criteria: * patient or legal representative unwilling to give informed consent * patient with other trauma lesions associated to hip fracture * patient with esophageal disease or chronic dissection of the descending aorta (contra-indications to esophageal doppler monitoring) * patient with known active neoplasia or with obvious metastatic hip fracture * allergy to hydroxy-ethyl starches * congenital hemostatic disorder

Keywords: hemodynamic optimisation esophageal doppler hydroxy ethyl starch hip fracture outcome elderly subjects (≥ 70 year old) general anesthesia
ali/ards clinical sub-phenotyping study

Conditions: Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)

Summary: 1. construct a structured clinical data and biosample information platform for chinese patients with acute lung injury/ acute respiratory distress syndrome. 2. by deciphering the heterogeneity of patients with acute lung injury/ acute respiratory distress syndrome, achieve clinical, longitudinal physiological, and biological sub-phenotyping to guide individualized precision treatment and improve prognosis.

acute lung injury/ acute respiratory distress syndrome is one of the most common and complex critical illnesses in clinical practice, with a high mortality rate of 45% to 50%. currently, effective therapeutic strategies for this condition are still lacking. increasing evidence suggests that the significant heterogeneity of this disease plays a crucial role in the poor treatment outcomes and high mortality rates observed in patients. therefore, this study aims to analyze the heterogeneity of acute lung injury/ acute respiratory distress syndrome patients and establish a clinical classification system for acute lung and extrapulmonary organ injuries. the objectives of this study include establishing a nationwide clinical database and biobank for acute lung injury / acute respiratory distress syndrome by collecting clinical data and biological samples from various provinces. by overcoming the barriers posed by diverse and heterogeneous data sources, mathematical and machine learning models will be utilized to construct clinical, physiological, and biological classification systems for acute lung and extrapulmonary organ injuries. the proposed classification model will be validated multiple times using international public databases and prospective acute lung injury/acute respiratory distress syndrome cohorts to ensure its stability and generalizability. the mapping relationship between different classifications and patient prognosis as well as treatment responsiveness will be explored. moreover, a machine learning-based supervised technique will be applied to develop a bedside simplified model (point-of-care model) and establish a bedside clinical classification decision system. ultimately, this research aims to provide a foundation for standardized and precision-guided clinical diagnostic and therapeutic pathways, promoting improved treatment outcomes and overall prognosis in acute lung injury/ acute respiratory distress syndrome.

Eligibility criteria:
inclusion criteria: * meet the diagnostic criteria for acute respiratory distress syndrome (ards) according to the updated global definition in 2023. * the patient or their legal representative signs an informed consent form. exclusion criteria: * individuals aged less than 18 years old. * those who refuse to participate in the study.

Keywords: acute lung injury/acute respiratory distress syndrome (ards) sub-phenotypes treatment strategies