Kornimate/medical-research-clean huggingface dataset:
integrative and complementary health practices (pics)

Conditions: Neoplasms; Epilepsy

Summary: complementary medicine, considered an unconventional approach, is performed in conjunction with conventional medicine. in brazil, integrative and complementary practices in health have been inserted by the national ordinance of integrative and complementary practices. the aim of this study is to evaluate the effects of laying on of hands with spiritual connection by the spiritist passe about mental and physical health and quality of life of individuals.

type of study: randomized controlled trial. the sample will consist of cancer and epileptic patients including individuals aged eigtheen years and over. patients will be referred by health professionals and social workers from lar da charidade, clinics hospital and attachments, as well as from the general community and will be invited to participate in the study at the center for integrative and complementary practices of the clinics hospital. participants will answer the questionnaires before the start of the study, after eight sessions and fiveteen days or the end of the research according to the group. the participants will be submitted to blood collection, when necessary.

Eligibility criteria:
inclusion criteria: * cancer patients: diagnosis of neoplasia receiving parenteral chemotherapy. * epileptic patients: clinical diagnosis of focal epilepsy exclusion criteria: * cancer patients: pregnant women, unable to understand the questionnaires; non-attendance of 3 sessions of therapy application and refusal to sign the consent form. * epileptic patients: people unable to understand the questionnaires; non-attendance of 3 sessions of therapy application and refusal to sign the consent form, as well as special groups (pregnant women, newly diagnosed epilepsy).

Keywords: complementary medicine laying on of hands cancer epilepsy complementary therapies
chase registry of patients with pulmonary hypertension receiving targeted therapy

Conditions: Pulmonary Hypertension

Summary: china registry for the characteristics and management strategies of patients with pulmonary hypertension using targeted therapy (chase study)

the purpose of this study was to establish the clinical characteristics and treatment strategies of targeted pulmonary hypertension patients in china: a multicenter, prospective case registry (chase) study to describe the clinical characteristics, treatment used, disease progression, and outcomes (e.g., death, hospitalization) of patients taking targeted drugs in real-world clinical practice. this study will collect high-quality real-world data that can be used as a standalone dataset or combined with other data sources to address critical issues in the ph field. this is a prospective, observational, multicenter study. the expected number of enrolled cases for the entire study: at least 5000; no experimental group and control group were divided. patients were followed up every 6 months ±2 weeks after enrollment for 3 years. the study selected patients who signed informed consent, aged 18-25 years, clinically diagnosed with pulmonary hypertension, and were applying or planning to apply targeted drugs for pulmonary hypertension as the study objects. the primary endpoint was the incidence of clinical exacerbations at 1 year after enrollment. secondary endpoints were all-cause mortality at 1, 2, and 3 years after enrollment, rate of lung transplantation or combined cardiopulmonary transplantation, 6-minute walking distance, nt-probnp level, who cardiac function grade, ratio of right ventricular end-diastolic diameter to left ventricular end-diastolic diameter, pulmonary hypertension targeted drug regimen, and incidence of associated adverse reactions.

Eligibility criteria:
inclusion criteria: * sign informed consent; * between the ages of 18 and 85; * clinical diagnosis of pulmonary hypertension, using or planning to use pulmonary hypertension targeted drugs (including any one or more of the following: prostacyclin analogues, endothelin receptor antagonists, phosphodiesterase inhibitors, soluble guanylate cyclase agonists and prostacyclin receptor agonists). exclusion criteria: * have a history of mental illness or drug or poison addiction, and can not sign informed consent or can not cooperate with the experimental study; * patients with malignant tumor and other diseases and life expectancy of less than half a year; * short-term (less than 2 weeks) patients taking targeted drugs for pulmonary hypertension
evaluation of intestinal brush border enzyme function in critically ill patients

Conditions: Critical Illness; Septic Shock; SIRS

Summary: the purpose of this study is to evaluate the role of several enzymes of the gut mucosa in preventing invasion of gastrointestinal bacteria.

systemic inflammatory response syndrome (sirs), sepsis, septic shock and concomitant multiorgan failure are major causes of morbidity and mortality in intensive care units. during sirs and septic shock the role of the gut seems to be uncertain. as it serves as an intestinal barrier which allows the symbiotic relationship between man and enteric bacteria, increased gut permeability during critical illness is accused to promote sepsis. brush border enzymes have the ability to detoxify lipopolysaccharides and prevent bacterial invasion across the gut mucosal barrier. a reduced brush border enzyme function could contribute to the gastrointestinal intolerance in critically ill patients, which is frequently observed. the aim of this study is to assess the influence of sirs and septic shock on brush border enzyme morphology and function in men.

Eligibility criteria:
septic shock: recruitment and inclusion criteria * 15 mechanically ventilated critically ill patients fulfilling criteria of sirs (2 symptoms: rr \> 20/min, hr \> 90/min, temp. \> 38°/\< 36°, 12g/l\< wbc \< 4g/l; assumed or proven infection, persistent hypotension refractory to fluid therapy and need for vasopressors. * time window for inclusion: up to 72h after onset of symptoms exclusion criteria * plt \< 50g/l, * pt \< 50%, * continuous therapeutic anticoagulation, * dic, st. p. mci within 14 days, * gastrointestinal perforation, * age \< 18 years, * age \> 80 years sirs: recruitment and inclusion criteria * 15 mechanically ventilated critically ill patients fulfilling criteria of sirs (2 symptoms: rr \> 20/min, hr \> 90/min, temp. \> 38°/\< 36°, 12g/l \< wbc \< 4g/l; assumed or proven infection * time window for inclusion: up to 72h after onset of symptoms exclusion criteria: * plt \< 50g/l, * pt \< 50%, continuous therapeutic anticoagulation, * dic, st. p. mci within 14 days, * gastrointestinal perforation, * age \< 18 years, * age \> 80 years healthy/controls: * 15 control subjects will be recruited from the outpatient ward referred to the endoscopy of the department of medicine iii - division of gastroenterology and hepatology for upper gi-endoscopy because of epigastric pain or reflux symptoms. inclusion criteria: * signed informed consent exclusion criteria: * patients with diarrhea of unknown origin, ibd or known celiac disease * age \< 18 years * age \> 80 years * plt \< 50g/l, pt \< 50% * therapeutic oral anticoagulation
measuring and modulating changes in eeg resting state functional connectivity during short-term and long-term pain

Conditions: Prolonged Pain, EEG, Resting State Functional Connectivity

Summary: background and aims: experimental prolonged pain models can shed more light on the cortical mechanisms involved in the transition from acute to chronic pain including changes in resting state functional connectivity (rsfc). this experiment aimed at examining the effect of 24-hour-capsaicin application on the rsfc of the default mode network (dmn), a prominent network in the dynamic pain connectome. methods: electroencephalographic (eeg) rsfc measured by granger causality was acquired at baseline, 1-hour, and 24-hour following the initial patch application (placebo or capsaicin). after 24 hours, the patch was cooled down then heated up to assess rsfc changes in response to pain relief and facilitation. pain was induced using a topical capsaicin patch (or placebo as control) on the right forearm and assessed on a 0-10 numerical rating scale (nrs).


Eligibility criteria:
inclusion criteria: healthy men and women, age 19-44, right-handed (assessed using the edinburgh handedness inventory, speak and understand english. exclusion criteria: 1. chili allergies 2. history of chronic pain or current acute pain 3. present or previous neurologic such as epilepsy, alzheimer disease, dementia, stroke, migraine and other headache disorders, multiple sclerosis, parkinson's disease, neuroinfections, brain tumours and head trauma. 4. present or previous musculoskeletal disorders such muscle/tendon strain, ligament sprain tension,tendonitis, degenerative disc disease, mechanical back syndrome, and ruptured/herniated disc. 5. present or previous mental illnesses such as depression, bipolar disorder, and schizophrenia. 6. pregnancy 7. current use of medications that may affect the trial (e.g. pain relieving medication and anti-inflammatory medication) 8. using hair products that may interfere with eeg conductance such as gel, except for shampoo, prior to the trial. 9. drug addiction defined as the use of cannabis, opioids or other drugs 10. consumption of alcohol, caffeine, or tobacco 6 hours before the experimental onset 11. lack of ability to cooperate -
gp chemotherapy in combination with anti-pd-1 and anti-tigit in unresectable advanced btc

Conditions: Biliary Tract Carcinoma

Summary: this is an open label, multi-center, phaseⅱstudy to evaluate the efficacy and safety of gp (gemcitabine/cisplatin) in combination with tislelizumab and ociperlimab as first-line treatment in participants with unresectable advanced biliary tract carcinoma (btc).

biliary tract carcinoma (btc) has an insidious onset, invasiveness, high malignancy, and no specific symptoms in the early stage, and most of them are in the middle and advanced stages at the time of diagnosis and have lost the chance of surgery. for patients with advanced btc, systemic therapy is currently the main choice, and gemcitabine/cisplatin (gp) is currently the "gold standard" for first-line treatment of advanced btc, but the efficacy is still unsatisfactory, and more and more clinical practice has found that gp-based combination therapy may have better efficacy. previous studies have shown that chemotherapy can improve the immunotherapy microenvironment and may have a synergistic anti-tumor effect in combination with immunotherapy. this study is to explore the efficacy and safety of gp in combination with anti-pd1 antibody (tislelizumab) and anti-tigit antibody (ociperlimab) as first-line treatment in participants with unresectable advanced btc.

Eligibility criteria:
inclusion criteria: * • subjects with a histopathological or cytologically diagnosis of btc * the participants must be required to sign an informed consent * at least one measurable lesion (recist 1.1) * no previous systematic treatment for btc * child-pugh score, class a * ecog performance status 0 or 1 * adequate organ function * life expectancy of at least 3 months exclusion criteria: * • diagnosis of mixed ampullary, hepatocellular, and cholangiocarcinoma * known history of a serious allergy to any monoclonal antibody * known central nervous system metastases and/or leptomeningeal disease prior to treatment * portal hypertension with esophageal or gastric varices within 6 months prior to initiation of treatment * any bleeding or thrombotic disorder within 6 months prior to initiation of treatment * any active malignancy prior to the start of treatment * active or history of autoimmune disease * other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation * pregnant or lactating women
efficacy and safety of dhea for myotonic dystrophy

Conditions: Myotonic Dystrophy

Summary: to test the efficacy and safety of two doses of dehydroepiandrosterone (dhea) in adults with myotonic dystrophy

myotonic dystrophy is an inherited disorder that affects 1 per 8000 adults. the disease is characterize by muscular dystrophy, myotonia, cardiac disorders, cognitive function impairment, hypersomnia, hair loss, endocrine disorders. recent small studies suggested that dhea treatment may improve muscle strength in adults with myotonic dystrophy. thus, the current study aims at investigating the safety and efficacy of a prolonged treatment with dhea in adults with myotonic dystrophy.

Eligibility criteria:
inclusion criteria: * myotonic dystrophy (genetically proven) * mdrs score of 3 or 4 exclusion criteria: * age \ 70 years * pregnancy or breastfeeding * poor compliance to treatment and follow up * inclusion in any other clinical trial * severe cardiac disease: acute myocardial infarction in the preceding 6 months, unstable heart failure, uncontrolled hypertension (systolic blood pressure \>180 mmhg or diastolic blood pressure \>100 mmhg after 10 minutes of rest in the lying position), severe arteritis, any past history of thrombose or embolic event, any past history of symptomatic arrhythmia) * chronic renal failure * chronic liver disease * long term mechanical ventilation * any ongoing cancer * any underlying endocrine disorders * impaired swallowing * previous treatment with dhea

Keywords: myotonic dystrophy hypersomnia dehydroepiandrosterone
elimination of antibiotics during citrate-anticoagulated continuous-veno-venous-haemodialysis

Conditions: Acute Kidney Injury; Bacterial Infection

Summary: acute kidney injury (aki) requiring renal replacement therapy is common in critically ill patients. the major causes of aki are severe sepsis and septic shock requiring effective antibiotic treatment. patients with sepsis on icus usually are haemodynamically instable so that renal replacement therapy is applied using continuous techniques. in recent years, the efficacy of renal replacement therapies has improved, namely by using regional citrate anticoagulation which improves filter lifetime and filter patency. at present, the extent of removal of antibiotic drugs using citrate-anticoagulated cvvhd in critically ill patients has not been investigated thoroughly. thus, the investigators want to investigate 1. whether and to what extent antibiotic drugs (piperacillin/tazobactam and imipenem/cilastatin) are removed during citrate-anticoagulated cvvhd per se 2. whether filter patency during citrate-anticoagulated cvvd remains stable during a treatment period of 72 h


Eligibility criteria:
inclusion criteria: * intensive care patients with acute kidney injury requiring continous renal replacement therapy with citrate-anticoagulation * age \> 18 y exclusion criteria: * \< 18 y * pregnancy * contraindications against citrate-anticoagulation or continous renal replacement therapy
hepatitis c treatment to prevent hiv, initiate opioid substitution therapy, and reduce risky behavior

Conditions: HCV; Buprenorphine; PreP

Summary: this is an open label, non-randomized, observational pilot study to evaluate a model of care for treatment of hepatitis c in people with ongoing injection drug use. participants will be treated with direct-acting antivirals (daa) as per standard of care and will concomittantly be offered pre-exposure prophylaxis for hiv prevention and buprenorphine for treatment of opioid use disorder when clinically indicated.

hepatitis c (hcv) is a chronic infection with significant morbidity and mortality. the development of directly acting antivirals (daa) has dramatically improved the cure rate of hcv treatment. however, despite the availability of effective therapy, the global epidemic of hcv infection continues to be driven by people with ongoing injection drug use (pwid), who are largely excluded from hcv therapy. several critical barriers exist preventing high-risk patients' entry to care, including (1) lack of engagement in the traditional healthcare system by marginalized patient populations, and (2) insurance restrictions due to concerns regarding treatment adherence and hcv reinfection. furthermore, ongoing injection drug use places these individuals at high risk of hiv acquisition. however, studies have repeatedly demonstrated that pre-exposure prophylaxis (prep) reduces hiv acquisition and opioid substitution therapy with buprenorphine reduces hiv and hcv acquisition in pwid. as such, we propose a comprehensive model of care to engage individuals with ongoing injection drug use in treatment of hcv, in conjunction with collocated services to prevent hiv acquisition and hcv reinfection, including pre-exposure prophylaxis and opioid substitution therapy. this pilot trial will demonstrate whether a comprehensive model of care can simultaneously treat hcv, and prevent hcv reinfection, hiv acquisition and effectively treat opioid use disorder.

Eligibility criteria:
inclusion criteria: 1. age 18 years old 2. able and willing to sign informed consent 3. chronically infected with hcv, defined as any individual with documentation of positive hcv antibody and positive hcv rna test (hcv rna of 2,000 iu/ml or greater). 4. willing to have samples stored for future use 5. ongoing injection drug use, defined as self-report of either: 1. phase 1 (first 100 enrolled participants) injection non-prescription drug use within three months of screening visit or 2. phase 2 (enrolled participants 101-200) use of non-prescription opioids within twelve months of screening visit exclusion criteria: 1. decompensated liver disease (childs pugh b or c) 2. unable to comply with research study visits 3. poor venous access not allowing screening laboratory collection 4. have any condition that the investigator considers a contraindication to study participation 5. pregnant or breastfeeding woman
stimulating self management in patients with fibromyalgia through web-based situational feedback

Conditions: Fibromyalgia

Summary: the overall objective of this randomized controlled study (rct) financed by the norwegian research council (grant no. 182012/v50) is to establish the effectiveness of situational feedback to the self-management of fibromyalgia syndrome (fms) using innovative means of patient-provider communication in a randomized controlled study (rct). thereby this project will contribute to the knowledge of treatment of patients with fms. the effectiveness of the intervention will be expressed in terms of a) reduced pain, b) psychometric outcomes, c) quality of life, d) improved engagement in daily activities and e) prevented transition to chronic disability. we furthermore aim to 1) determine the effectiveness of providing regular situational feedback in enhancing self-management and, consequently 2) study the effectiveness of enhancing self-management in reducing pain and physical disability. self-management of chronic pain is increasingly seen as an important tool in providing adequate care to patients with fms and other types of chronic non-malignant pain. enhancing the patient's self-management of her/his condition is thought to be effective in reducing pain and disability. however, sufficient empirical evidence to support this is yet unavailable. this may be due to the non-situational nature of many interventions studied so far: patients are taught management skills in a clinical setting, and may not be able to successfully use these skills in daily care. therefore, enhancing self-management of chronic pain, by providing immediate feedback that is directly related to patient's daily life ("situational" feedback) complementary to care-as usual, is thought to be more effective than conventional interventions in a clinical setting. this may even be even more effective when the patient receives quick response feedback using mobile communication technology, i.e. any place any time.


Eligibility criteria:
inclusion criteria: * female, having wide spread pain like fms (ipcs codes cd-10, 79.0 - coded) for at least three months ,\> 18 years, able to understand norwegian; able to use the webenabled mobile phone. exclusion criteria: * substantial psychological problems in need of treatment with intensive psychotherapy.
safety, tolerability and pharmacokinetic study of kl1333 in healthy male volunteers

Conditions: MELAS Syndrome; Mitochondrial Respiratory Chain Deficiencies

Summary: the purpose of this first in human study is to investigate the safety and tolerability of kl1333 after a single oral dose and to investigate the pharmacokinetic characteristics of kl1333 after a single oral dose.


Eligibility criteria:
inclusion criteria: * 19 - 45 years of age at the time of screening * subjects weighing ≥55 and ≤90 kg with bmi between 18 and 27 kg/m2 * subjects who agreed to voluntarily participate in this study and comply with all the study requirements by signing informed consent form after being informed of the nature of this study and understanding all aspects of this study exclusion criteria: * history of clinically significant hepatic, renal, neurologic, immunologic, respiratory, endocrine disease or hematologic•oncologic disease, cardiovascular, psychiatric disease * history of disease or surgery of the gastrointestinal tract that could interfere with kinetics of the study drug. simple hernia repair or appendectomy are excepted. * history of clinically significant or relevant allergy/hypersensitivity * blood ast (sgot), alt (sgpt) \>1.5 of upper limit * egfr value of ≤90ml/min/1.73m2 * systolic blood pressure of \ 160 mmhg * diastolic blood pressure of \ 100 mmhg * any abnormalities in 12-lead ecg at screening visit * subjects who showed positive result in drug abuse tests, or who has history of drug abuse within 60 days prior to the time of screening * subjects who took prescribed medications or oriental medicine within 14 days or over-the-counter (otc) medications or vitamins within 7 days prior to the dose of the study drug (however, the subject can be included if other criteria are met according to the discretion of the investigator) * subjects who were administered any investigational products within 3 months from the first dose of the study drug * subjects who have donated whole blood (60 days) or partial blood (30 days), or received blood transfusion * subjects who have had alcohol consistently (\>21units/week, 1unit=10 g of pure alcohol) or who is not able to stop drinking alcohol throughout the study period * subjects who have smoked until 90 days prior to the study initiation or who are not able to stop smoking throughout the study period * subjects who are not able to stop taking grapefruit/caffeine from 3 days prior to the first dose of the study drug throughout the study period * subjects who plan for pregnancy during the study period or who are not able to use established contraceptive method * subject who judged not eligible for study participation by investigator

Keywords: mitochondrial dna trnaleu(uur) m.3243a<g mutation