Kornimate/medical-research-clean huggingface dataset:
the effectiveness of well-being therapy on mental health and self-efficacy of patients with ulcerative colitis

Conditions: Ulcerative Colitis

Summary: ulcerative colitis (uc) is a chronic and lifelong disease that causes disabilities for sufferers and causes mental health disorders in the patients. for this reason, it is important to know which psychotherapy is more effective for uc patient's problems, and since no research has been done on the effectiveness of well-being therapy on the mental health problems of these patients, this research can help psychologists and other specialists in this field to help patients with uc and other chronic disease. the present study is conducted with the aim of determining the effectiveness of mental well-being on the mental health and quality of life of patients with ulcerative colitis. the research method was a semi-experimental type with a pre-test-post-test design with a control group. the study population included all patients with ulcerative colitis who were previously diagnosed with ulcerative colitis by a gastroenterologist and referred to one of the gastroenterology centers for treatment. the criteria for entering the patients into the study were: definitive diagnosis of ulcerative colitis according to the opinion of a gastroenterologist, consent to participate in the study, having at least a high-school education and an age range of 18 to 60 years. the patients who were excluded from the study were: patients who have acute psychiatric or other medical disorders , patients who have participated in counseling or psychotherapy sessions in the last six months and patients who lose motivation to participate in the interview or are absent for more than two sessions. the convenience sampling method was used. the list of patients with inflammatory bowel diseases was provided to the researcher after the consent of the head of the digestive disease research institute. 300 ulcerative colitis patients of this list were contacted according to the criteria for entering the study, and they were invited to participate in the treatment sessions after a brief explanation about the objectives of the sessions, sessions duration and time. finally, 32 patients volunteered and were randomly assigned to one of the following groups: 16 people (9 women and 7 men) were in the well-being therapy group and 16 people (8 men and 8 women) were in the control group. in the post-test phase, one person in the study group stopped working, and in the follow-up phase, which was done 6 months later , the study did face any shortages.


Eligibility criteria:
inclusion criteria: - definitive diagnosis of ulcerative colitis according to the opinion of a gastroenterologist, consent to participate in the study, having at least a high-school education and an age range of 16 to 60 years. exclusion criteria: patients who have acute psychiatric or other medical disorders , patients who have participated in counseling or psychotherapy sessions in the last six months and patients who lose motivation to participate in the interview or are absent for more than two sessions
impact of the 'reserved therapeutic space' nursing intervention: an intervention study in acute mental health units

Conditions: Nurse-Patient Relations; Psychiatric Hospitalization

Summary: aims: to evaluate the effectiveness of the "reserved therapeutic space" intervention for improving the nurse-patient therapeutic relationship in acute mental health units in spain, as well as its impact in terms of quality of care and patients' perceptions of coercion. design: multicenter intervention study with control group. methods: the study will be carried out in 12 mental health units in spain. given the conditions of evaluation in real clinical practice, paired randomization will be performed to assign centers to intervention and control groups. the "reserved therapeutic space" intervention to be tested has been co-designed and validated by both nurses and patients. the quality of the therapeutic relationship, the care received, and perceived coercion among patients will be assessed at baseline and at discharge using instruments validated in our context. an estimated 131 patients per group are expected to participate. funding was granted in july 2021 by the institute of health carlos iii (pi21/00605, ministry of science and innovation) and in october 2021 by the college of nurses of barcelona (pr-487/2021). the proposal was approved by all the research ethics committees of participating centers. discussion: this study is expected to demonstrate the effectiveness of a specific nursing intervention on patient health outcomes including the level of the therapeutic relationship, the quality of care, the level of coercion and other specific indicators for acute mental health units. impact: this project will lead to changes in clinical practice, transforming the current models of organization and care management in mental health hospitalization units, promoting the quality of the therapeutic relationship and, ultimately, the quality of person-centered care.


Eligibility criteria:
inclusion criteria: * adults hospitalized in mental health inpatient units who voluntarily consent to participate in the study exclusion criteria: * adults hospitalized in mental health inpatient units who present a language barrier, mechanical restraint, contraindication by the clinical referent, cognitive impairment, or intellectual disability at the time of recruitment.

Keywords: nurse-patient therapeutic relationship quality of psychiatric care mental health nursing acute psychiatric care
treatment of pneumonia, diarrhoea and fever in children by community health workers

Conditions: Pneumonia, Diarrhea, Fever

Summary: the investigators propose to test the feasibility and acceptability of community health workers (ashas and anms) being able to treat sick children in the community. there is a national policy for treatment for children aged 2-59 months with illnesses such as pneumonia, diarrhea and fever by community health workers (chws), this policy has not been implemented as yet in haryana. this research will identify barriers and opportunities for use of chws as treatment sources.

using indepth interviews, focus group discussions and other qualitative research methods barriers and opportunities for promoting use of ashas as a treatment source for diarrhea, pneumonia and fever will be identified. an intervention package which includes training of ashas and anms to treat uncomplicated cases of pneumonia, diarrhea and fever, ensuring they have required supplies, creating awareness in community and monitoring and supervising the treatment provided by them will be implemented in primary health centre areas in haryana, india. ashas will treat cases of fast breathing pneumonia with amoxicillin and refer children with danger signs or chest indrawing pneumonia. three rounds of cross sectional surveys will be conducted to ascertain prevalence of morbidity, careseeking and hospitalizations in children aged 2 to 59 months.

Eligibility criteria:
inclusion criteria: * children aged 2-59 months with uncomplicated pneumonia or diarrhoea or fever exclusion criteria: * refusal for participation * diarrhea with dehydration * danger signs * chest indrawing pneumonia

Keywords: pneumonia fever diarrhoea
study evaluating the long-term safety and efficacy of vx-445 combination therapy

Conditions: Cystic Fibrosis

Summary: this study evaluated the long-term safety, efficacy, and pharmacodynamics of elexacaftor (elx, vx-445) in triple combination (tc) with tezacaftor (tez) and ivacaftor (iva) in subjects with cystic fibrosis (cf) who are heterozygous for the f508del mutation and a gating or residual function mutation (f/g and f/rf genotypes).


Eligibility criteria:
key inclusion criteria: * completed study drug treatment in parent study (vx18-445-104); or had study drug interruption(s) in parent study but completed study visits up to the last scheduled visit of the treatment period in the parent study key exclusion criteria: * history of study drug intolerance in parent study other protocol defined inclusion/exclusion criteria may apply.
effect of intravenous lidocaine, used to attenuate pain with propofol injection, on defibrillation threshold testing

Conditions: Pain

Summary: the use of lidocaine, as an anesthetic drug, during implantation of an implantable cardioverter-defibrillator(icd)will not result in a clinically significant alteration of the defibrillation threshold during icd placement.

summary: the purpose is to observe the incidence of successful defibrillation on the first attempt during implantation of an implantable cardioverter-defibrillator (icd) among patients who receive a standard dose of intravenous lidocaine (for attenuation of pain associated with propofol injection) versus patients who do not receive an intravenous lidocaine dose. during implantation of an icd, defibrillation threshold (dft) testing is performed. dft is calibrated as the lowest energy delivered by the icd that will successfully terminate malignant arrhythmia. lidocaine, a routine anesthetic agent, is also identified as an antiarrhythmic drug. experimentally, lidocaine has been shown to increase thresholds during dft' testing due to the drugs dual effect. the rationale behind this project is that the lidocaine may yield falsely elevated dft, resulting in higher calibration of the icd device. this alteration can affect icd battery and overall icd life. comparisons between study groups may elucidate effects of iv lidocaine on dft.

Eligibility criteria:
inclusion criteria: * any person referred to the hahnemann university hospital electrophysiology laboratory for a clinically indicated icd implant exclusion criteria: * any person under the age of 18 years * inability to give an informed consent * allergy to lidocaine * receiving lidocaine treatment for pain or arrhythmia * contraindication for dft testing * not consenting for dft testing * receiving energy other than 10-12.5 joules as initial dft test * implant of icd on the right side * dft not planned to be performed during icd implant * epicardial placement of icd leads * use of single coil icd lead * subpectoral icd implantation * cephalic cutdown used for central venous access * require more than 3mg/kg of 1% sq lidocaine for local anesthesia * pregnant women or prisoners

Keywords: lidocaine implantation icd
epidrum for thoracic epidural analgesia

Conditions: Pain

Summary: the purpose of this study is to evaluate the use of the epidrum device to identify the epidural space in patients requiring thoracic epidural analgesia.


Eligibility criteria:
inclusion criteria: * elective major thoracic surgery requiring thoracic epidural analgesia exclusion criteria: * contraindication to epidural anesthesia * marked spinal deformities or a history of spinal instrumentation
immunglobulin m enriched intra venous immunoglobulin (ivig) therapy in adult respiratory distress syndrom (ards) patients

Conditions: Respiratory Distress Syndrome, Adult; Septic Shock

Summary: 57 patients with adult respiratory distress syndrome (ards) requiring extracorporeal membrane oxygenation (ecmo) therapy were analyzed retrospectively. 28 patients had received immunglobulin m-enriched immunoglobulin therapy (ivig); 29 patients did not receive ivig therapy. these patients were analyzed regarding length of stay in intensive care unit (los icu), length of stay (los) in hospital and regarding mortality.

57 patients with ards requiring ecmo therapy were analyzed retrospectively. 28 patients had received igm-enriched immunoglobulin therapy (ivig); 29 patients did not receive ivig therapy. patient characteristics, like acute physiology and chronic health evaluation (apache) and sepsis-related organ failure assessment (saps) score, preexisting diseases, origin of infection, duration of ecmo therapy were analyzed in these patients. these patients were further analyzed regarding los icu, los in hospital and regarding mortality.

Eligibility criteria:
inclusion criteria: * all data available * ards with ecmo therapy exclusion criteria: * data missing

Keywords: ivig ards ecmo
a study of a bivalent influenza peptide conjugate vaccine in healthy adults

Conditions: Influenza

Summary: this is a first in man study evaluating the tolerability and immunogenicity of bipcv/imx (v512) at increasing concentrations of influenza viral peptides a/m2+b/ha0 peptides and imx, a saponin-based adjuvant.


Eligibility criteria:
inclusion criteria: * subject is in good physical health * subject is not in the category of individuals recommended by the cdc to receive influenza vaccine for the upcoming 2 influenza seasons * subject agrees not to seek vaccination with licensed influenza vaccines during the study * female subjects agree to use acceptable birth control for 6 weeks prior to first dose of vaccine until 1 month post dose 3 exclusion criteria: * subject has a history of allergic reaction to the vaccine components * subject has has a fever within 3 days of screening * subject had a vaccination with an inactive virus within 14 days of dose 1 * subject had a vaccination with a live virus within 30 days of dose 1
initial pilot study to evaluate the safety and temporary symptom improvement efficacy of ckd-981

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to prove that the temporary symptom improvement effect on knee osteoarthritis using ckd-981

the aim of this pilot study is to evaluate the efficacy and safety of ckd-981 in patients with mild to moderate degenerative knee osteoarthritis who have been experiencing pain more than 8 weeks

Eligibility criteria:
inclusion criteria: * patients between 40 years and 80 years old * patients who have experiencing knee pain more than 8 weeks * vas more than 40 mm * kellgren and lawrence grade 2 and 3 in x' ray knee joint exclusion criteria: * previous knee surgery in affected side * patients with rheumatoid arthritis, connective tissue disease, paget's disease * infection of knee joint * bmi more than 35kg/m2

Keywords: ckd-981
a community-based depression screening intervention for middle-aged suicide

Conditions: Suicide

Summary: the purpose of this study is to examine the effectiveness of a community-based depression-screening program for suicide prevention among middle-aged adults, the investigators conducted a quasi-experimental intervention study, using a parallel cluster design with communities at municipal level as the unit of allocation and individuals as the unit of analysis.

suicide is a major cause of premature death, particularly among middle-aged adults, in the majority of western and asian countries. a strong association of suicide and depression often indicates the necessity of a high-risk approach for suicide prevention. improvements in identification and treatment can lead to better depression outcomes and suicide prevention. the investigators hypothesize that a 4-year community-based intervention, consisting of universal depression screening and subsequent care support in the target areas and health education programs, would result in reduced suicide rates among the middle-aged adult population in areas with a high suicide rate.

Eligibility criteria:
inclusion criteria: * a municipal area located in the following 4 aomori second medical zones: hachinohe, kamitosan, aomori, and tsugaru. * a municipal area with the higher suicide rate than the prefectural average. * a municipal area having the sufficient and coverable size to serve the intervention (population 10,000-99,999). exclusion criteria: * a municipal area receiving further intervention including a depression screening for middle-aged adults.

Keywords: suicide prevention
atlantis:extensive type a dissections and thoracic/ thoraco-abdominal aneurysms repair with lupiae hybrid technique

Conditions: Aortic Aneurysm

Summary: to prospectively evaluate the safety and efficacy of the lupiae hybrid technique for the treatment of * thoracic or thoraco-abdominal aortic aneurysms * thoracic aortic type a dissections 2. to compare the safety and efficacy of the lupiae hybrid technique with historical groups (literature review, other hybrid techniques, lupiae retrospective patients)

lupiae technique: hybrid repair of thoracic or thoraco-abdominal aneurysms of different etiology and type a dissections with a two-stage procedure: 1. surgical arch reconstruction with a dacron multibranched surgical prothesis 2. endovascular implantation of a thoracic stent graft

Eligibility criteria:
inclusion criteria: 1. patient willing to sign the informed consent, or in case of acute patients that should arrive at the hospital in unconsciousness status, patient's first degree relatives willingness to sign the informed consent and patient's willingness to re-consent for the study participation once he/she is again conscious. and 2. patients with extensive thoracic or thoraco-abdominal aortic aneurysms (\>55 mm diameter), involving the ascending, arch and descending aortic segments, but not involving the renal arteries (at least 15 mm of healthy tissue above the most proximal renal artery). or 3. patients with extensive type a aortic dissection (debakey type i) with at least one of the following minimum criteria: * an initial false lumen diameter measured in the upper descending thoracic aorta \>22 mm; * total aortic diameter measured in the descending thoracic aorta \>45 mm; * true lumen's compression (true lumen \<10% of total aortic lumen); * non-controlled hypertension; * persistent pain; * rupture or imminent rupture; exclusion criteria: 1. patient has a standard contraindication to the implant of thoracic stent graft; 2. patient unable to commit to follow-up schedule; 3. patient has medical conditions that preclude protocol required testing or limit study participation; 4. patient is enrolled or intend to participate in another clinical trial during the course of this study; 5. less than 18 years of age; 6. pregnancy; 7. a life expectancy of less than one year, except for patients with extensive type a aortic dissection (debakey type i)

Keywords: lupiae techinque aortic aneurism aortic dissection
third-generation car-t-cell therapy in individuals with hiv-1 infection

Conditions: HIV-1

Summary: to evaluate the safety of autologous car-t-cell therapy in individuals lived with hiv-1 infection, car t cells are infused after ex vivo expansion and transduction with lentiviral vectors encoding a broadly neutralizing hiv-1 scfv antibody.

this study is a prospective, single-center, single-arm, open-label and phase i clinical trial. subjects with cd4+t cell counts greater than 350/μl and viral loads of \<50 copies/ml over 1 year by antiviral treatment are enrolled. t cells are stimulated with cd3 and cd28, transduced with lentiviral vectors encoding a broadly neutralizing hiv-1 scfv antibody and expanded for approximately 2 weeks. then, patients are infused with car t cells at a dosage of 1×10\^5 car-t cells/kg body weight. if this dose is well tolerated, dosing will be increased to 5×10\^5 car t cells/kg body weight. after infusion, adverse events, and hiv-1 latent reservoir size and car levels in peripheral blood will be monitored to assess the safety of car-t-cell treatment, potential therapeutic efficacy and kinetics of car t cells.

Eligibility criteria:
inclusion criteria: 1. aged 18 to 70 years 2. hiv-1 infection by confirmed test; 3. receiving antiviral treatment ≥ 1 years; 4. current cd4+ t cell count \> 350 cells/μl; 5. hiv-1 rna levels of \< 50 copies/ml for at least a year; 6. patients who agrees to use two effective methods of contraception to avoid pregnancy during the study period. 7. patients who sign the informed consent form prior to inclusion in the study. exclusion criteria: 1. patients with concomitant hav, hbv, hcv, hdv, hev, ebv, cmv or syphilis infection; 2. a history of aids-related opportunistic infections and tumors within 1 year prior to enrollment; 3. a history of corticosteroids or immunosuppressive drugs for autoimmune diseases by physicians within the last 2 years; 4. participants with clinically significant laboratory abnormalities as follows: * hemoglobin ≤ 10 gm/dl (female), \<11g/dl (male) * absolute neutrophil count ≤ 1×10\^9/l * platelet count ≤100×10\^9/l * alanine aminotransferase (alt)≥ 2.5 x uln * aspartate aminotransferase (ast) ≥ 2.5 x uln * total bilirubin \> 1.5 uln * serum creatinine \>110 μmol/l * international normalized ratio (inr) \>1.5 or activated partial thromboplastin time (aptt) \>45 s 5. patients with severe psychiatric illness, drugs or alcohol abuse; 6. a woman who is in pregnancy or lactation; 7. a history of central nervous system disease, such as cerebral hemorrhage, dementia, epilepsy and autoimmune diseases; 8. patients with a non-aids-related serious underlying disease; 9. patients who participate in another clinical study currently which may affect the results of this study.

Keywords: car t cells hiv-1 infection safety hiv latent reservoir
brain excitability during self-paced voluntary movements

Conditions: Movement Disorder; Healthy

Summary: this study will use transcranial magnetic stimulation to examine how the brain controls movement by sending messages to the spinal cord and muscles and what goes wrong with this process in disease. normal healthy volunteers 18 years of age and older may be eligible to participate. in transcranial magnetic stimulation, an insulated wire coil is placed on the subject's scalp or skin. brief electrical currents are passed through the coil, creating magnetic pulses that stimulate the brain. during the stimulation, participants will be asked to tense certain muscles slightly or perform other simple actions. the electrical activity of the muscle will be recorded on a computer through electrodes applied to the skin over the muscle. in most cases, the study will last less than 3 hours.

the purpose of this study is to investigate the influence of volitional movement on excitability of ipsilateral as well as contralateral motor cortical neurons controlling homologous and surrounding muscles. transcallosal and surrounding inhibitions are well known phenomenon to suppress unwanted movements during voluntary action, which is often disturbed in various movement disorders. transcranial magnetic stimulation (tms) has been used to investigate these inhibitory mechanisms, but the inhibitory influence during and after voluntary movement has not been well elucidated yet. in normal volunteers, we plan to determine if voluntary movements of one finger influence the cortical excitability responsible for surrounding as well as contralateral homologous muscles, using voluntary movement-triggered tms. the primary outcome measures would be any changes in motor evoked potential (mep) size and intracortical inhibition (ici) parameters.

Eligibility criteria:
normal adult volunteers 18 or more years old. subjects must not have medico-surgical illness. subjects must not have neurological illness. subjects must not have psychiatric illness. subjects must not be taking any medication with potential influence on nervous system function. subjects must not have a pacemaker. subject must not have an implanted medical pump. subjects must not have a metal plate or a metal object in the skull or eye. subjects must not have a history of seizure disorder.

Keywords: transcranial magnetic stimulation motor cortex cerebral inhibition corpus callosum evoked potential healthy volunteer normal control