Kornimate/medical-research-clean huggingface dataset:
effect of endoplasmic reticulum stress on metabolic function

Conditions: Insulin Resistance; Diabetes; Obesity

Summary: normally, the hormone insulin works to help keep blood sugar normal. however, as a person gains weight, insulin does not work as well and blood sugar tends to be a little higher than normal. this is called "insulin resistance". two investigational drugs (not approved by the food and drug administration) for the treatment of high lipid levels or insulin resistance are being examined in this study: one drug is called tauroursodeoxycholic acid (tudca), the other is called sodium phenylbutyrate (pba). this study is designed to test if tudca and/or pba is effective in people who are obese with insulin resistance and high lipids. we hypothesize that pharmacologically-induced decreases in er stress will improve insulin action and hepatic lipid metabolism in obese subjects.

a 4-week randomized, controlled trial will be conducted to evaluate the following specific aims in obese subjects: determine the effect of treatment with tudca or pba on: 1. body fat distribution: a) intrahepatic triglyceride (ihtg) content, b) intramyocellular triglyceride (imtg) content, and c) intra-abdominal fat content, assessed by using magnetic resonance spectroscopy and magnetic resonance imaging. 2. in vivo insulin sensitivity in adipose tissue (suppression of lipolysis), liver (suppression of glucose production), and skeletal muscle (stimulation of glucose uptake), assessed by using the hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope tracer infusion. 3. vldl-triglyceride (tg) and vldl-apolipoprotein-b100 (apob-100) secretion rates, assessed by stable isotopically labeled tracer infusion methods. 4. skeletal muscle intracellular insulin signaling, fatty acid oxidation, and markers of inflammation, assessed by evaluating skeletal muscle biopsies ex vivo. 5. adipose tissue insulin signaling, er stress, and inflammation, assessed by evaluating adipose tissue biopsies ex vivo.

Eligibility criteria:
inclusion criteria: * bmi range 30 to 45 * sedentary (defined as regular exercise \< 1 h per week or \< 2 x/week for the last 6 months) exclusion criteria: * active or previous infection with hepatitis b or c * liver diseases * history of alcohol abuse * current alcohol consumption \> 20 g/day * severe hypertriglyceridemia ( \> 400 mg/dl) * active peptic ulcer disease * taking cholestyramine or oral contraceptives * women who are pregnant or lactating

Keywords: obesity insulin resistance type ii diabetes
first experimental study of transference work - in teenagers (fest-it)

Conditions: Depression

Summary: the first experimental study on transference work - in teenagers (fest-it) will be a randomized clinical trial, which will be designed to explore effects of transference work in dynamic psychotherapy in adolescents with major depressive disorder (mdd). the design of the study is a so-called dismantling design, in which a single component is added and/or varied to an existent treatment method (psychodynamic psychotherapy). thus, the efficiency of a specific technique (transference interventions) can be identified. the primary hypothesis is that the transference group may have a more favorable course over time than will the comparison group. the second hypothesis is that patients with a history of low quality of object relations score and/or personality disorders-might benefit more from therapy with transference work than from therapy without. the third hypothesis is that female adolescents may have better treatment effect of transference work than male adolescents.

the effect of transference interventions in depressed adolescents and the moderator moderating effect of quality of object relations, personality disorder and gender will be explored. methods and study design: the first experimental study of transference work-in teenagers (fest-it) will be a randomized clinical trial with a dismantling design. the study is aimed to explore the effects of transference work in psychodynamic psychotherapy for adolescents with depression. one hundred patients ages 16 to 18 years old will be randomized to one of two treatment groups, in both of which general psychodynamic techniques will be used. the quality of adolescents' relationships will be a central focus of the study.the patients will be treated over 28 weeks with either a moderate level of transference intervention or no transference intervention. follow-up will be at 1 year after treatment termination. gender personality disorder (pd) and quality of object relations (qor) will be the preselected moderators. the object of this clinical trial is to explore the effect of transference interventions in psychodynamic psychotherapy in adolescents with a major depressive disorder. using a randomized and dismantling design, we hope that the study will add more specific knowledge to the evidence base.

Eligibility criteria:
inclusion criteria: * adolescents aged 16 - 18 years exclusion criteria: * pervasive developmental disorder, * psychosis, or substance abuse

Keywords: transference work psychodynamic depression treatment adolescent
changes in cerebral blood flow in patients treated with spinal cord stimulation for low back and leg pain

Conditions: Pain; Low Back Pain; Leg Pain

Summary: the primary objective of this study is to identify the brain regions in which activity is affected by scs. baseline cerebral blood flow scans with the device turned off will be generated compared to scans produced with the device operating at parameters which produce optimal coverage of the painful areas. the relationship between cerebral blood flow and pain rating scores will be evaluated in both conditions.

spinal cord stimulation (scs) is known to be effective in pain management. some evidence exists that scs may cause changes in cerebral blood flow. this study will be a novel pet examination of activity in brain regions affected by scs. this activity will be compared with the pain intensity and distribution. further, by examining cerebral blood flow at different doses of stimulation, relationships between scs, brain perfusion, and pain relief can be drawn. this study will contribute to the elucidation of the mechanism of action of scs.

Eligibility criteria:
inclusion criteria: * have had one or more back surgery procedures. * have used an active precision scs device for chronic low back and bilateral leg pain for at least 6 weeks. * have bilateral leg pain. * have a baseline vas of \>4 (without stimulation). * have greater than 50% reduction in pain with scs at optimal settings * be 18 years of age or older. * have the cognitive and functional capability to operate the controls for the device, to comply with directions during the study, and willing to participate in all study activities. * be capable of reading and understanding patient information materials and giving written informed consent. exclusion criteria: * have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints. * have undergone a surgical lead revision or had any precision components replaced after initial implantation. * are allergic to any of the injected media. * are pregnant or lactating. * have any contraindication to the pet scan procedure itself or exposure to the intravenous radioactive tracer (h215o). * have participated in any drug or device trial in the last 4 weeks or are currently participating in another drug or device trial.

Keywords: pain neurostimulation
evaluating the addition of hemodiafiltration to evlp - impact on the regeneration of marginal donor lungs

Conditions: Lung Diseases

Summary: the primary objective of the study is the evaluation of the effect of hemodiafiltration during ex vivo lung perfusion in marginal donor lungs, and its feasibility. the hypothesis of this study is that this therapy could stabilize perfusate electrolyte composition, remove toxins and waste products, normalize ph levels and prevent edema formation, thereby reconditioning marginal donor lungs for transplantation. the proposed pilot study addresses the unmet clinical needs in several aspects: a) for the first time a homeostatic device will be introduced in evlp to reach stable perfusate composition; b) the proposed modification of the standard evlp could lead to longer perfusion times, making elective transplantation possible and setting the base for possible ex vivo lung treatments; c) the ultimate effect of the proposed study is to increase organ availability through reconditioning of marginal donor lungs.


Eligibility criteria:
inclusion criteria: * marginal donor lungs according to the ishlt criteria (18) * pao2/fio2 ratio \< 400 (with fio2=1.0 and peep=5-8cmh2o) * donor age ≥ 55 years * smoking history ≥ 20 pack-years * infiltrates in chest radiograph * significant secretions in bronchoscopy * organisms on sputum gram stain * donor age \> 18 years exclusion criteria: for donor organs: * bilateral consolidations in donor lungs * lungs from donors with chest trauma * lungs from drowned donors for patients receiving lung transplantation: * inclusions in other interventional studies * patients on the intensive care unit (icu) prior to transplantation, with mechanical ventilation and/or extracorporeal membrane oxygenation (ecmo) support * re-transplantations
genetic analysis of liver cancer

Conditions: Liver Cancer; Hepatitis B; Hepatitis C; Hepatobiliary Cancers; Hepatobiliary Cancers Liver

Summary: liver cancer is a leading cause of cancer deaths worldwide. while the molecular pathogenesis of liver cancer has been extensively studied, less is known about how the molecular biology of liver cancer influences clinical outcome and treatment response. we are developing a translational research program that will characterize molecular changes in liver cancer. we plan to use molecular information obtained from studying liver tumor tissues to develop new diagnostics and treatment regimens for patients with these cancers. the experimental approach will require freezing fresh tumor tissues obtained from surgical procedures, which will be subsequently used for analysis of dna, protein and mrna expression. many patients with liver cancer are referred to the stanford liver tumor board for consultation and treatment recommendations. we propose to gather tissue samples from those who subsequently undergo biopsy, liver resection surgery, or transplant surgery.


Eligibility criteria:
inclusion criteria:3.1.1 male or female patients 18 years of age and above. 3.1.2 patients diagnosed with liver cancer based on biopsy or serum alpha-fetoprotein level, associated with characteristic hypervascular liver tumors on triphasic spiral ct scan or mri. patients with non-cancer liver conditions such as cirrhosis, adenoma, cholangioma, or nodular hyperplasia. patients with metastatic tumor from anther organ, such as metastatic colon cancer. 3.13 ability to understand and the willingness to sign a written informed consent document. exclusion criteria:3.2.1female patients who are pregnant or nursing will be excluded from the study.
toward understanding drivers of patient engagement with digital mental health interventions - part i

Conditions: Depression, Anxiety

Summary: this pilot study is a precursor to a subsequent clinical trial that will test the impact of a set of automated motivational messages on patient engagement with a digital mental health intervention. the pilot study aims to systematically employ patient feedback to develop the automated motivational messages that will be used in the subsequent clinical trial.

this is an in situ user-centered design pilot study to generate feedback on the automated motivational messaging the investigators are developing. participants will download a digital mental health intervention (intellicare) to use for three weeks. during this three-week period, participants will receive automated motivational messages on a randomized schedule. that is, each day they will be randomized to either receive an automated motivational message (60% likelihood) or not receive an automated motivational message (40% likelihood). on days when a participant receives a message, the participant will be prompted to complete a brief survey on their reaction to the message received. at the end of three weeks, participants will be asked to complete a qualitative interview to provide further feedback on messages under development. the primary outcome in this study is participant ratings from the brief surveys provided after automated motivational message delivery. we will also, however, look at participant feedback on messages under development in the qualitative interview as well as whether receiving a message makes users more likely to engage with the dmhi (intellicare) during the three hours following message delivery.

Eligibility criteria:
inclusion criteria: * age 18-80 * patient health questionnaire-8 (phq-9) score≥10 and/or generalized anxiety disorder-7 (gad-7) score≥8 indicating clinically significant depression or anxiety respectively * owns a smartphone * fluent in english * individual has a mass general brigham primary care provider exclusion criteria: * diagnosis of bipolar disorder, any psychotic disorder, or a current substance use disorder per patient's report or medical record. * acute and/or unstable medical problem that may interfere with participation (e.g., scheduled for surgery in the next two months).

Keywords: mhealth engagement depression anxiety
efficacy of delayed coloanal anastomosis for medium and lower rectum cancer treatment. phase 2 clinical trial (cascador)

Conditions: Medium and Lower Rectal Cancer

Summary: hypothesis: in france, approximately 12,000 new rectal cancers are diagnosed each year. frequency is one and a half times higher in men than in women. the average age of diagnosis is 65. unlike colon cancer, technical management remains challenging with unresolved operating difficulties. morbidity of surgical procedures remains high with a very large number of preventive or curative stoma derivations. reference in surgical treatment is total excision of the rectum and its mesentery, followed by continuity restoration by immediate coloanal anastomosis (acai). in this procedure, rate of fistula that results is reported in the literature between 15 and 25%. an alternative to acai is delayed coloanal anastomosis without reservoir (acad). based on retrospective experiences, we form the hypothesis that acad offers a much lower rate of fistula (\<5%) and allows diminution of preventive stoma derivation practice. morbidity and mortality are reduced, and patient's quality of life greatly improved. direct costs (consumables intraoperative, hospitalization, stoma complications) and indirect (pocket-fitting stoma) are greatly reduced. this study is a multicentre, two arms, phase 2 clinical trial.


Eligibility criteria:
inclusion criteria: * histologically proven rectal adenocarcinoma. * medium or lower rectum tumour requiring removal of the entire rectum and its mesorectum. * t1 n+ or t2 n+ or t3 n+ or t3 n0 and m0 tumour. * age between 18 and 75 years . * asa ≤ 2. * sphincter continence compatible with coloanal anastomosis. * patients who received preoperative radiotherapy alone or chemotherapy and radiotherapy. * patient affiliated to social security. * for patients of childbearing age, use of contraception. * patient information and consent for study participation exclusion criteria: * other histology of rectal cancer. * t1 n0 or t2 n0 or t4 tumour. * metastatic disease m1. * history of cancer except cervix in situ carcinoma or skin basal cell carcinoma. * patient with psychological, social, family or geographical reasons who couldn't be treated or monitored regularly by the criteria of the study * patients deprived of liberty or under guardianship. * pregnant or nursing women.

Keywords: rectal cancer coloanal anastomosis phase 2 clinical trial
mallampati score for prediction and prognosis of postoperative mortality and morbidity and safety profiles of patients undergoing laparoscopic cholecystectomy in qassim region

Conditions: Mallampati Score; Difficult Intubation; Patient Satisfaction; Cholestasis; Cholecystitis

Summary: to predict the majority of mallampati score for the patients in qassim region who undergoing laparoscopic cholecystectomy surgery.

a preoperative assessment by anaesthetic staff should include the mallampati score, as there is a direct correlation between the amount of space in the pharynx and the laryngoscopic view during intubation which has been refined by cormack and lehane (1984) clinical diagnosis one of most important factor indicating the postoperative complications like mallampati score. as the mallampati class zero per se is not indicating with any difficulty of airway management unless other airway characteristics indicating to the difficulty. as well as if the epiglottis may be large and overhanging, it's not common with airway difficulty in mallampati class zero airway. the mallampati score idea is to estimate the size of the tongue related to the oral cavity and the displacement of the tongue by the laryngoscope blade was likely to be easy or difficult. it also assessed whether the mouth could be opened adequately to permit intubation research objectives to predict the majority of mallampati score for the patients in qassim region who undergoing laparoscopic cholecystectomy surgery. method: observational, multi hospital, regional study inclusion criteria: 1. age: 20 - 50 years 2. laparoscopic cholecystectomy surgery 3. body mass index (bmi): ≤ 35 exclusion criteria: 1. age less than 20 years 2. age more than 50 years 3. body mass index (bmi) \> 35 data management and analysis plan: all data will be entered and analyzed using spss v28© (ibm corp., armonk, ny, usa). categorical variables will have expressed as frequencies and percentages, while continuous variables will have presented as means ± standard deviations (sds). the chi-squared test will have used to evaluate demographic and health-related characteristics associated with name of the clinic as well as type of service provided to the patient. a p-value of less than 0.05 was considered to be statistically significant ethical considerations: * all investigators completed the bioethics certificate from the national committee of bioethics at king abdulaziz city for science and technology. * all investigators declare there is no conflict of interest.

Eligibility criteria:
inclusion criteria: 1. age: 20 - 50 years 2. laparoscopic cholecystectomy surgery 3. body mass index (bmi): ≤ 35 exclusion criteria: 1. age less than 20 years 2. age more than 50 years 3. body mass index (bmi) \> 35

Keywords: mallampati score surgery anesthesia
clinical evaluation of pet-ct for staging of colorectal lung metastases

Conditions: Metastatic Colorectal Cancer

Summary: surgery has been available for the treatment of pulmonary metastases in metastatic colorectal cancer and promising overall survival was observed in retrospective studies with selected patients. this study investigated whether the preoperative fdg- pet/ct scan influences survival in this patient group. furthermore, we tried to identify other prognostic factors associated with overall survival and progression-free survival.


Eligibility criteria:
inclusion criteria: * patients over 18 years with pulmonary metastases eligible for pulmonary metastasectomy exclusion criteria: * second primary cancer within the last 2 years (exception basal cell carcinoma of the skin) * pregnancy, * drug addiction, * renal dialysis

Keywords: pet-ct pulmonary metstasectomy
e-cigarette aerosol, conventional cigarette smoke, and myocardial perfusion

Conditions: Coronary Artery Disease; Myocardial Perfusion

Summary: e-cigarettes deliver nicotine by creating an aerosol of ultrafine particles. many questions remain about the size and composition and especially about the potential toxicity of these particles. thus, a key unanswered question-and the research question proposed-is whether e-cigarette aerosol triggers the same acute impairment in coronary microvessel function as does conventional cigarette smoke, which delivers a very well-defined exposure to fine particles and many fold greater exposure to toxic (combustion) products including volatile organic compounds (such as acrolein) that have been implicated in the pathogenesis of tobacco-related coronary disease. because the effects of nicotine on the human coronary microcirculation remain incompletely defined-with multiple potential vasodilator and vasoconstrictor actions each of which may vary by dose-we will determine the comparative effects of conventional cigarette smoke against e-cigarette aerosol with no nicotine, with low-dose nicotine, and with high-dose nicotine.


Eligibility criteria:
inclusion criteria: * age 18-49 * regular cigarette smoker defined as at least 1 pack year and ≥ 5/day * e-cigarette smoker defined as ≥ 1/week in the last 6 months. exclusion criteria: * sub-optimal echocardiography images as determined by the sonographer and/or investigators. * history of cardiopulmonary (including asthma or use of inhalers), * history of diabetes or dyslipidemia * history of psychiatric illness * blood pressure \> 140/90 * body mass index ≤ 18.5 or ≥ 30 kg•m2 * evidence of any of the above by physical examination, electrocardiogram (ecg) or echocardiogram * resting heart rate \> 100 beats/min * cardiac rhythm disorder, specifically: rhythm other than sinus, supraventricular tachycardia (svt), atrial fibrillation, ventricular tachycardia * use of prescription medication except oral contraceptive pills * history of illicit drug use (self-stated) * pregnant * any other condition(s) deemed by the physician investigators that put subjects at risk for participating in the study

Keywords: myocardial perfusion electronic cigarettes cigarettes cigarette smoking
bioequivalence of two insulatard® formulations in healthy subjects

Conditions: Diabetes; Healthy

Summary: this trial is conducted in europe. the aim of this trial is to test for bioequivalence between two formulations of insulatard® in healthy subjects.


Eligibility criteria:
inclusion criteria: * considered generally healthy upon completion of medical history and physical examination as judged by the investigator * body mass index (bmi) between 18.0 and 27.0 kg/m\^2, inclusive * non-smoker, defined as no nicotine consumption for at least one year * fasting plasma glucose below or equal to 100 mg/dl (5.6 mmol/l) exclusion criteria: * previous participation in this trial or other clinical trials within the last 3 months * body weight above 87.5 kg * pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (iud) that has been in place for at least 3 months, or sterilisation, or the oral contraceptive pill, which should have been taken without difficulty for at least 3 months, an approved hormonal implant) * history of alcohol or drug abuse