Kornimate/medical-research-clean huggingface dataset:
insulin resistance and substrate metabolism after acute erythropoietin (epo) administration

Conditions: Insulin Sensitivity

Summary: recently epo receptors have been found in human muscle tissue, but what is still not known is the physiological role of these receptors. in this study the researchers want to investigate if there is any effect of a acute administration of epo on insulin resistance and/or substrate metabolism in muscle tissue.

recently epo receptors have been found in human muscle tissue, but what is still not known is what the physiological role of these receptors are. it has previously been shown that growth hormone mediate insulin resistance. the gh receptor and epo receptor belong to the same family of cytokine receptors, and thereby share many of the same signalling pathways. in this study we want to investigate if there is a similar effect on insulin resistance and/or substrate metabolism after acute administration of epo in human muscle tissue. different signalling pathways are investigated på western blotting, and insulin sensitivity are measured be a hyperinsulinemic euglycemic clamp, and substrate metabolism is measured by the forearm model.

Eligibility criteria:
inclusion criteria: * healthy persons * between 18 and 30 years * normal weight (bmi: 18-25) exclusion criteria: * severe heart disease (nyha 3) * uncontrolled hypertension * previous cerebrovascular disease * proliferative retinopathy * diabetes * musculo-skeletal diseases

Keywords: erythropoietin human muscle tissue insulin sensitivity substrate metabolism
pilot of pragmatic sbirt study

Conditions: Substance Use Disorders; Pain

Summary: veterans seeking compensation for musculoskeletal (msd) conditions often develop chronic pain and are at high risk for substance misuse. this study is designed to pilot test the screening, brief intervention and referral to treatment for pain management (sbirt-pm) intervention. sbirt-pm is designed to reduce pain and reduce risky substance use among veterans applying for va benefits for a musculoskeletal condition, in part by helping veterans get connected to comprehensive pain treatment. this pilot will involve a 2-year period to arrange for sbirt counselors at a single site to counsel veterans throughout new england by phone with sbirt-pm to test the acceptability and feasibility of the intervention.

in 2015 alone, 97,223 new veterans under age 35 began receiving compensation for injuries related to their military service. in total, there are 559,999 post-9/11 veterans being compensated for back or neck conditions, and a partially overlapping 596,250 for limitation of flexion in joints. veterans seeking compensation for musculoskeletal conditions often develop chronic pain and are at high risk for substance misuse. early intervention is needed to arrest worsening pain and risky substance use, particularly among post-9/11 veterans for whom engagement in non-pharmacological pain treatment has the potential to improve their overall quality of life and spare them the complications of opioid treatments. the service-connection application is an ideal point-of-contact for initiating early intervention treatments for these at-risk veterans. this study is designed to pilot test the screening, brief intervention and referral to treatment for pain management (sbirt-pm) intervention. sbirt-pm is designed to reduce pain and reduce risky substance use among veterans applying for va benefits for a musculoskeletal condition, in part by helping veterans get connected to comprehensive pain treatment. this pilot will involve a 2-year period to arrange for sbirt counselors at a single site to counsel veterans throughout new england by phone with sbirt-pm to test the acceptability and feasibility of the intervention. during the two-years pilot trial, the team will prepare sbirt-pm for implementation by establishing communication (relational coordination is the theoretical framework) between the "hub" where the sbirt-pm clinician is sited and the "spoke" sites, establishing study-related procedures, and piloting the intervention at each of the eight va medical centers in new england.

Eligibility criteria:
inclusion criteria: * post-9/11 veteran applying for msd-related compensation, as ascertained from filed claim, * reports pain ≥4 on the pain numerical rating scale (threshold for moderately severe pain); * availability of a landline or cellular telephone for sbirt-pm. exclusion criteria: * reports inability to participate during the study enrollment call * received three or more non-pharmacological pain treatment modalities (as previously categorized within the last 12 weeks from va.
post-market surveillance study to evaluate the quality of life and the safety and effectiveness of the tigr® matrix after reconstructive breast surgery

Conditions: Implant Based Breast Reconstruction

Summary: the goal of this observational study is to evaluate the quality of life of participants who have undergone implant-based breast surgery. this will be done using the breast-q questionnaire. the study also aims to demonstrate that the fully resorbable tigr® matrix is safe and effective.

this national, multicentre, prospective, non-randomized post market surveillance clinical device investigation will be performed to obtain information on the resorbable surgical mesh tigr® matrix used during an implant-based breast surgery. data will be collected on the participants' quality of life as well as on the rate of complications of the device under investigation.

Eligibility criteria:
inclusion criteria: * women with histologically confirmed breast cancer or precancerosis or genetic pre- existing conditions with increased risk of breast cancer or with a family history all with an indication for skin sparing or nipple sparing mastectomy (ssm or nsm); or women with indication of prophylactic operation * the health of women must comply with ecog performance status 0-2 * the decision for the implementation of the tigr® matrix was made before and independently from study enrollment * participant is mentally able to understand the nature, aims, or possible consequences of the clinical investigation * patient information has been handed out and subject signed informed consent * participant has attained full age of 18 years exclusion criteria: * pregnancy or breast-feeding patients * known intolerance to the material, mesh-implants under investigation * metastatic breast cancer (with a life expectancy \< 5 years) * medicinal dis-regulated diabetes * inadequate bone marrow function with neutrophil granulocytes\<1500 and blood plates \< 100.000/µl * lack or withdrawn of written patients informed consent * lack of patient compliance regarding data collection, treatment or follow-up investigations in the scope of the protocol * participant is institutionalized by court or official order (mpdg §27) * participation in another surgical clinical investigation that influence the surgical technique or outcome.

Keywords: tigr® matrix quality of life
effects of imagery therapy vs progressive muscle relaxation therapy on patients with functional abdominal bloating

Conditions: Functional Gastrointestinal Disorders

Summary: 65% of the general population reported experiencing moderate to severe bloating symptoms. bloating could be disturbing to patients and frustrating to the physicians as an effective treatment is still lacking. guided imagery (gi) involves the structured visualisation of mental images with somatic sensory; whereas progressive muscle relaxation (pmr) focuses on tightening and relaxing the body's specific muscle groups. the development and validation of gi or pmr interventions to treat patients with functional abdominal bloating are relatively novel.

the baseline variables of the patient would be obtained at the outpatient gastrointestinal medical clinic. a thorough general clinical interview that encompasses medical and psychological history, discussion of the nature and severity of the current symptoms, and review of past treatments and conclusions of any medical evaluation and tests. this is to make sure that the patients have been comprehensively evaluated medically and to rule out other causes of abdominal bloating before reaching a firm diagnosis of functional abdominal bloating as suggested in rome iv criteria. questionnaires will be given out and patients were asked to fill it up on the spot. electrical activity and abdominal circumference would be measured at an enclosed space with appropriate privacy and accompanied by a chaperone.

Eligibility criteria:
inclusion criteria: * participants with abdominal bloating as determined using the malay version rome iii criteria which was validated and translated by past researchers (lee et al, 2012) and/or patients who were suggested by clinicians. * participants must be 18 years and above, and of either gender. * participants are able to read, write, or understand the malay language. exclusion criteria: * patients with abdominal bloating due to organic disorder * patients with recent abdominal surgeries (within 3 months) or previous major abdominal surgeries * patients with major neurological and psychological disorders including stroke, schizophrenia, major depression. * patients with medical history which may be the red flag for other fgids and organic disorders . * patients who are on psychotropic medications or psychotherapy which may confound outcome of imagery of sham intervention.

Keywords: guided imagery progressive muscle relaxation relaxation techniques psychotherapy hypnosis sports psychology bloating gastrointestinal disease distention
water-aided colonoscopy in inflammatory bowel disease patients

Conditions: Inflammatory Bowel Disease

Summary: water-aided insertion of the colonoscope has been repeatedly proven to beneficial in terms of lower discomfort and need for sedation during colonoscopy. patients with inflammatory bowel diseases (ibd) undergo repeated colonoscopy in course of their disease. according to our preliminary experience, water immersion could be beneficial while scoping these patients. as far as the investigators know, water-aided colonoscopy has never been studied in this indication. results of our trial might support use of water-aided colonoscopy in common practice and decrease associated discomfort in ibd patients.


Eligibility criteria:
inclusion criteria: * known diagnosis of inflammatory bowel disease * planned diagnostic outpatient colonoscopy * signed informed consent * willingness to undergo unsedated colonoscopy exclusion criteria: * ulcerative proctitis * bowel resection longer than ileocecal resection * requirement for sedation

Keywords: water colonoscopy crohn´s disease ulcerative colitis
national survey on hypertension

Conditions: Hypertension

Summary: describe the clinical characteristics of hypertensive patients aged of 75 years and older seen in general practitioner consultation according to their renal damage


Eligibility criteria:
inclusion criteria: * male or female aged 75 years or older * with a diagnosis of hypertension treated or not, seen in general practitioner consultation * who has given his/her consent to participate to the study. exclusion criteria: * patient who participated to a clinical trial

Keywords: hypertensive patients aged of 75 years and older renal damage clinical characteristics of hypertensive patients aged of 75 years and older seen in general practitioner consultation according to their renal damage
an observational research of crizotinib's hepatic toxicity in non-small cell lung cancer patients

Conditions: Non-Small Cell Lung Cancer

Summary: crizotinib, an inhibitor of anaplastic lymphoma kinase (alk), was approved by food and drug administration (fda) for the treatment of patients with alk-positive non-small cell lung cancer (nsclc) and its administration has achieved considerable success. however, adverse effects inevitably occurred and the most common one was hepatic toxicity, appearing as elevating alanine aminotransferase(alt) and aspartate aminotransferase(ast). therefore, the investigators try to figure out the mechanism of crizotinib-inducing hepatic toxicity, and explore whether there is any biological marker to diagnose this side effect in an early stage, which may realize individualized therapy with more efficacy and less side effects.


Eligibility criteria:
inclusion criteria: 1. patients who were histologically and cytologically confirmed nsclc at stage iii or iv 2. harbored alk fusion gene and took crizotinib 3. age:18\~75years 4. eastern cooperative oncology group performance status(ecog ps): 0\~2 points 5. the expected lifetime is more than 12 weeks after being recruited exclusion criteria: 1. patients who also suffered from other malignant tumor 2. uncontrolled systemic diseases,central nervous system (cns) metastasis 3. clinically active interstitial lung diseases 4. severe liver dysfunction caused by hepatic cirrhosis or hepatitis （child-pugh class c, total index score 10-15 points） 5. taking drugs that interact with crizotinib

Keywords: non-small cell lung cancer crizotinib hepatic toxicity
acupuncture for pain control after elective caesarean section

Conditions: Postoperative Pain

Summary: the study entitled "acupuncture vs. placebo acupuncture and vs. standard therapy for pain control after elective caesarian section - a randomized controlled trial" aims to investigate whether acupuncture with indwelling fixed needles reduces pain and analgesic requirement as compared to placebo and standard therapy in patients after after elective caesarian section (cs) in the period from january 2015 to may 2016. for that purpose 180 adult patients scheduled to elective elective cs in spinal anesthesia will be recruited according to eligibility criteria. 120 patients will be randomized either to verum or placebo acupuncture, 60 patients will be included in non-randomized "standard therapy" arm. the outcome measures are: postoperative analgesic requirement, pain intensity, incidence of side effects and physiological parameters.


Eligibility criteria:
inclusion criteria: * patients with an american society of anaesthesiologists physical status of i to iii scheduled for elective caesarean section in spinal anaesthesia * surgery time does not exceed 60 minutes * patients without previous opioid and psychotropic medication * patients ranged 19-45 years old * patients who have given written informed consent exclusion criteria: * recidivist alcoholics * local skin infection at the sites of acupuncture * age \ 45 years * switching to general anaesthesia in cases where spinal anaesthesia fails * surgery time more than 60 minutes * intraoperative complications (bleeding, required blood transfusion more than 6 units of packed cells, cardiovascular instability, required catecholamines except for short hypotension after induction of spinal anaesthesia ) * patients who consumed opioid medication at least 6 months before surgery * patients who are unable to understand the consent form and fill in the study questionnaire * history of psychiatric disease
trial of bilateral tdcs for depression

Conditions: Depression

Summary: transcranial direct current stimulation (tdcs) is a novel treatment approach for depression that has shown promising efficacy in four recent double-blind, randomized, sham-controlled trials (rct) and a meta-analysis. mood, cognitive test performance and biomarkers will be measured during the trial.


Eligibility criteria:
inclusion criteria: 1. participant meets criteria for a dsm-iv major depressive episode. 2. madrs score of 20 or more. exclusion criteria: 1. diagnosis (as defined by dsm-iv) of: any psychotic disorder (lifetime); eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder (current or within the past year); mental retardation. 2. history of drug or alcohol abuse or dependence (as per dsm-iv criteria) within the last 3 months (except nicotine and caffeine). 3. inadequate response to ect in the current episode of depression. 4. participant is on regular benzodiazepine medication which is not clinically appropriate to discontinue. 5. participant requires a rapid clinical response due to inanition, psychosis or high suicide risk. 6. neurological disorder or insult, e.g., recent stroke (cva), which places participant at risk of seizure or neuronal damage with tdcs. 7. participant has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites. 8. female participant who is pregnant, or of child-bearing age, sexually active and not using reliable contraception (urine test for pregnancy will be used). 9. participants who are not fluent in english will not be included in the trial for safety reasons.
using diffuse noxious inhibitory control (dnic) to predict acupuncture therapy outcome: a pilot study

Conditions: Pain

Summary: the investigators hypothesize that acupuncture modifies the dnic efficiency and that dnic can serve as a predictor to identify 'good responders' to acupuncture early in therapy.


Eligibility criteria:
inclusion criteria: * healthy women with a progesterone-coated intrauterine device (mirena), and * men greater than or equal to 18 years old. exclusion criteria: * acupuncture treatment in the previous six weeks, to discount any persisting effect of acupuncture. * treatment of a pain condition with pain medication. * regular use of benzodiazepines. * skin diseases, such as scleroderma, psoriasis or eczema. * an adverse event due to acupuncture therapy. * pregnant women. * women without a progesterone-coated intrauterine device (mirena). * anyone older than 60 years of age, fatigued, with a pacemaker icd, artificial joint, prolonged bleeding time/hemophilia, open wounds, or a known susceptibility to profound analgesia after acupuncture treatment.

Keywords: pain acupuncture dnic electroacupuncture
long-term safety and efficacy study of deucravacitinib in participants with systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: the main objective of the trial is to characterize the long-term safety and tolerability of bms-986165 in subjects with systemic lupus erythematosus (sle).


Eligibility criteria:
inclusion criteria: * completion of sle study (nct03252587) through the protocol-required treatment period, and currently receiving blinded study drug. note: if a subject is not receiving blinded study drug due to exceptional circumstances (eg, missed investigational product \[ip\] due to covid-19 pandemic, delays in study approval, etc), the subject may be allowed to enroll with approval from the bms clinical trial physician or designee. exclusion criteria: * any disease or medical condition that, in the opinion of the investigator, would make the subject unsuitable for this study, would interfere with the interpretation of subject safety or study results, or considered unsuitable by the investigator for any other reason * evidence of active tuberculosis (tb) other protocol-defined inclusion/exclusion criteria apply

Keywords: systemic lupus erythematosus
partnership to improve nutrition and adiposity in prenatal clinical care: a pilot and feasibility study

Conditions: Pregnancy

Summary: this study will pilot and assess feasibility of a prenatal intervention for obese pregnant women based on the diabetes prevention program (dpp). intervention group participants will meet with a clinic dietitian for 15 minutes at every prenatal appointment to complete a dpp-based curriculum and receive breastfeeding education. control group participants will receive usual prenatal care. outcomes include reach and dose of the intervention, gestational weight gain, dietary intake, physical activity, and breastfeeding in the first 6 weeks postpartum.

this study will pilot and test feasibility of a prenatal lifestyle intervention designed to limit gestational weight gain and prevent gestational diabetes. the intervention is based on the diabetes prevention program lifestyle intervention, will include prenatal breastfeeding education and online peer group support, and will be integrated into the participants' regular prenatal appointments. women (n=24) will be enrolled in early pregnancy. after baseline assessments (demographics, maternal diet, physical activity, mental health), women randomized equally to the intervention or usual care conditions. further data collection will occur at approximately 24 weeks gestation, 36 weeks gestation, and 6 weeks postpartum, and clinical data (weight, pregnancy and obstetric complications) will be abstracted from medical records at the end of the study. outcomes include reach and dose of the intervention, gestational weight gain, dietary intake, physical activity, and breastfeeding in the first 6 weeks postpartum. the investigators hypothesize that the intervention will reduce gestational weight gain, improve maternal dietary intake, increase total energy expenditure, and increase breastfeeding exclusivity in the first 6 weeks postpartum.

Eligibility criteria:
inclusion criteria: * singleton pregnancies of \<12 weeks gestation * pre-pregnant body mass index \>=30 * speak and understand english * plan to continue care at the clinic through pregnancy and postpartum exclusion criteria: * pre-existing diabetes * history of serious chronic illnesses * history of prior gestational diabetes * prior delivery at \<37 weeks gestation * prior delivery of infant weighing \<2500g

Keywords: gestational weight gain
the effectiveness of a mechanical debridement instrument in reducing bioburden in chronic wounds

Conditions: Acute Wounds; Chronic Wounds

Summary: this prospective clinical trial will compare the bacterial burden in the wound bed and on the periwound skin before and after mechanical debridement with ez debride using fluorescence imaging. after consenting, the ulcers of eligible subjects are measured, photographed and undergo the moleculight imaging procedure (mlix). the ulcer is mechanically debridement with the ez debride device after which a second mlix procedure is performed. the investigator will then compare the two images.

acute and chronic wounds burden healthcare systems across the globe. in the united states the cost of nonhealing wounds approximates 100 billion dollars.1-3 the presence of bacteria in and around the wound impedes wound healing. clinicians treat elevated wound bacterial levels with mechanical and sharp debridement, topical antiseptics and systemic antibiotics. however, evidence on the best methods to reduce bacterial load is lacking. the ez-1 clinical trial will utilize the latest fluorescence imaging technology to investigate whether mechanical debridement using the ez debride® tool reduces bacterial burden.

Eligibility criteria:
inclusion criteria: 1. adult patients with acute or chronic wounds that have been present for a minimum of 4 weeks. 2. a signed and dated informed consent form. 3. subject is willing and able to comply with instructions and scheduled visits. exclusion criteria: 1. the subject has other concurrent conditions that in the opinion of the investigator may compromise subject safety. 2. the subject's wound has not been present for at least 4 weeks.