Kornimate/medical-research-clean huggingface dataset:
human umbilical-cord-derived mesenchymal stem cell therapy in active ulcerative colitis

Conditions: Ulcerative Colitis

Summary: phase i-ii clinical trial - safety and efficacy of umbilical-cord-derived mesenchymal stem cell (uc-msc) in patients with active ulcerative colitis，randomized, single blind, controlled prospective study.

phase i-ii clinical trial - safety and efficacy of umbilical-cord-derived mesenchymal stem cell (uc-msc) in patients with active ulcerative colitis，randomized, single blind, controlled prospective study. thirty patients will be selected and randomized into two groups: the first group of 15 patients will receive a sole injection of uc-msc and the remaining 15 patients will comprise the control group. every patient will maintain their standard treatment of active ulcerative colitis, with maximum tolerated dosage without side effects. the day of infusion will be considered day zero. from that moment, followup will be divided into 0-1 week, 1 week-2 week,2 week-3 week, 3 week-1 month, and 3 month-6 months. clinical results will be analyzed after completion of 6 months of followup.

Eligibility criteria:
inclusion criteria: * the diagnosis of active uc must have been confirmed by endoscopic and histological evidence. * with mild and moderate disease. * men and women 18-65 years of age. * signed informed consent * capable of good communication with researchers and follow the entire test requirements exclusion criteria: * patient with associated diseases such as diabetes mellitus, hypertension, dyslipidemia, atherosclerosis and malabsorption syndrome. * with autoimmune diseases (lupus, hiv, cancer and hepatitis), colitis (infectious, post-radiation, post-drug, indeterminate) and crohn's disease. * abnormal hepatic or renal function * prior history of malignancy * pregnant or unwilling to practice contraceptive therapy or breast feeding females

Keywords: cellular therapy active ulcerative colitis phase 1/2 clinical study human umbilical cord mesenchymal stem cell allogeneic stem cell transplantation uc
olive oil massage effect for reduction of preterm sepsis (omeps)

Conditions: Sepsis; Pre-Term; Late-Onset Neonatal Sepsis

Summary: the omeps trial is a randomized clinical trial in the western region of saudi arabia. conducted to assess the safety and feasibility of olive oil as massage for preterm infants and if associated with reduced risk of late-onset sepsis.


Eligibility criteria:
inclusion criteria: 1. preterm infants born at one of the participated centers. 2. preterm infants born at ≥24weeks gestation and ≤32weeks gestation 3. birth weight ≥ 500gm up to 2000 gm. exclusion criteria: 1. outborn infants. 2. preterm infants \ 32 wk 3. preterm infants \ 2000gm 4. critically ill patients, e.g., hemodynamic unstable, culture-confirmed neonatal sepsis, hydrops fetalis, life-threatening congenital anomalies. 5. congenital skin anomalies or infection 6. major surgical procedure 7. any patient whose parents refuse consent. 8. death within 48 hours of life.

Keywords: olive oil massage preterm late-onset sepsis
doxorubicin hci liposome injection versus weekly docetaxel in patients first relapse metastatic breast cancer

Conditions: Breast Cancer

Summary: the efficacy of single agent liposomal doxorubicin as compared to single agent docetaxel will be evaluated as first line treatment in metastatic breast cancer patients, with subsequent crossover to the opposite arm at disease progression or patient intolerance. we will explore this as well as any possible cross resistance between these two agents.

upon determination of eligibility, patients will be randomly assigned to one of two treatment arms: * liposomal doxorubicin * docetaxel for ever 2 patients treated, 1 will receive treatment a (liposomal doxorubicin) and 1 will receive treatment b (docetaxel). patients demonstrating progression on either arm will be eligible for cross over to treatment in the other arm, provided patient still meets the eligibility laboratory and performance status criteria. the study is not blinded so both the patient and the doctor will know which treatment has been assigned.

Eligibility criteria:
inclusion criteria: to be included in this study, you must meet the following criteria: * metastatic breast cancer confirmed by biopsy * prior adjuvant/neoadjuvant treatment allowed * measurable disease * able to perform activities of daily living with minimal assistance * age 18 years or older * adequate bone marrow, liver and kidney function * normal heart function * written informed consent exclusion criteria: you cannot participate in this study if any of the following apply to you: * pre-existing moderate peripheral neuropathy * history of significant heart disease * meningeal metastases. * prior chemotherapy for metastatic breast cancer * no measurable disease (including bone only, pleural effusions, etc.) * receiving herceptin therapy. * women who are pregnant or lactating. please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Keywords: breast cancer
development of patient tailored guideline of physical activity for lung cancer

Conditions: Lung Cancer

Summary: this study aims to propose a perioperative comprehensive intervention based on health behavior model to improve cardiopulmonary function and quality of life among lung cancer patients following

this study aims to propose a perioperative comprehensive intervention based on health behavior model to improve cardiopulmonary function and quality of life among lung cancer patients following: 1. understanding multi-dimensional factors affecting cardiopulmonary function and quality of life 2. development of multidisciplinary comprehensive intervention 3. evaluation the effects of comprehensive intervention using cluster design

Eligibility criteria:
inclusion criteria: * lung cancer patients before surgery exclusion criteria: * eastern cooperative oncology group performance status \<1 * neoadjuvant therapy * multiple cancer * recurrent lung cancer.

Keywords: physical activity cardiopulmonary function quality of life perioperative management comprehensive intervention health behavior model
nesp pediatric study

Conditions: Pre-dialysis; End Stage Renal Disease

Summary: open-label, randomized study of nesp in pediatric subjects 18 years of age or younger. subjects will receive study drug (nesp or rhuepo) for 28 weeks after a 2 week screening and baseline period. during the study, procedures include bloodwork for laboratory assessments and vital signs. dose titration determined by hemoglobin values taken weekly during the study. antibody samples taken at baseline and during the end of study assessments. a physical examination and laboratory tests will conclude the study.


Eligibility criteria:
inclusion criteria: * 1 to 18 years of age * esrd receiving dialysis or cri with egfr less than 30 ml/min * baseline hemoglobin 9.5 - 12.5 g/dl and iron replete * stable rhuepo therapy for 8 weeks exclusion criteria: * scheduled for a living-related kidney transplant * uncontrolled blood pressure * seizure activity * hyperparathyroidism * major surgery within 12 weeks or active inflammatory disease * currently receiving antibiotics * clinical evidence of malignancy * pregnant or breast-feeding
ccta improves clinical management of stable chest pain

Conditions: Coronary Computed Tomography Angiography; Stable Chest Pain; Optimal Medical Therapy; Invasive Coronary Angiography; Revascularization; Major Adverse Cardiovascular Events; Coronary Artery Disease

Summary: the investigator aims to prospectively enroll patients who were referred for coronary computed tomography angiography (ccta) for the assessment of stable chest pain (scp) suspected of obstructive coronary artery disease (cad). all patients underwent ccta according to established guidelines and local institutional protocols. the imaging data were evaluated using different image post-processing software to comprehensively analyse anatomical, functional and histological information of coronary. this study will determine if ccta-based imaging evaluation can provide more informaton to improve clinical management for scp, including fewer mace and better decision-making of downstream investigations and therapeutic interventions.


Eligibility criteria:
inclusion criteria: * symptomatic patients with scp suspected of obstructive cad. * referred for ccta for the assessment of scp. * ≥18 years of age. * signed informed consent. exclusion criteria: * acute coronary syndromes * previous cad or coronary revascularization * nonsinus rhythm * cardiomyopathy, valvular disease, congenital heart disease or left cardiac insufficiency because of other reasons
bosentan therapy in children with functional single ventricle

Conditions: Congenital Heart Defects; Functional Single Ventricle

Summary: bosentan is a kind of dual endothelin receptor antagonist.the purpose of this study is to investigate if bosentan therapy can modify the outcome of children with functional single ventricle.

increased pulmonary vascular resistance (pvr) is a serous issues in children with functional single ventricle during the staged operative period. the purpose of this study is to investigate if bosentan therapy can improve the survival and life quality after staged fontan procedure in the children with high risk of increased pvr.

Eligibility criteria:
inclusion criteria: * signed informed consent obtained from patient's legally acceptable representative. * pediatric patients waiting for staged fontan procedure with high risk of increased pvr after bidirectional cavopulmonary connection (bcpc) * transpulmonary pressure gradiant (tpg) \> 10mmhg when the obstruction of anastomosis and lung problem were excluded. * with the diagnosis of high risk of increased pvr, such as associated with tapvc, after pulmonary artery banding, after systemic to pulmonary shunt more than 6 months, and et al. * diagnosed as increased pvr with catheterization. exclusion criteria: * pah associated with conditions other than those mentioned above, e.g., ipah, pah secondary to portal hypertension, hiv patient with opportunistic infection * psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements * ast and/or alt \> 3 times the upper limit of normal ranges. * hemoglobin concentration \< 75% the lower limit of normal ranges * treatment or planned treatment with another investigational drug within 3 months of screening * treatment with calcineurin-inhibitors (e.g., cyclosporine a and tacrolimus), fluconazole, glibenclamide (glyburide) within 1 week of enrollment of this study * known hypersensitivity to bosentan or any of the excipients

Keywords: pulmonary vascular resistance heart defects, congenital receptors, endothelin bosentan
use of the efisiotrack system for monitoring patients with shoulder orthopedic injuries

Conditions: Shoulder Injuries

Summary: to evaluate the effect on clinical variables of monitoring exercises prescribed for shoulder injury rehabilitation with the efisiotrack platform in patients of the rehabilitation service at university hospital of elche.

patients who be referred to the rehabilitation service of the university hospital of elche (spain) for physiotherapy treatment (manual therapy, exercise, stretching, and electrotherapy) after suffering orthopedic injury or surgery in the shoulder joint complex will be considered for enrollment in the study. patients will performed the prescribed physical therapy treatment, at least three times per week in sessions of 45 minutes in the hospital setting (application of manual therapy and physical modalities as ultrasound, heat/cold, laser, magnetic field therapy) together with completion of the exercise program for functional recovery of the upper extremity (exercises for muscle strength, scapular stability, joint mobility, and proprioception). following baseline examination, patients will be randomly assigned to either physiotherapist-supervised exercise (control group) or monitoring by the efisiotrack system (experimental group) to perform active exercises as part of their shoulder rehabilitation. these will be performed independently by each patient in a hospital room without supervision by the physiotherapist. the following patient-reported outcome measures will be used to assess participants' shoulder pain and function: the disabilities of arm, shoulder and hand (dash) score and the constant-murley (cm) score. all participants will be assessed at baseline on their first visit to the physical therapy area and at one-month follow-up.

Eligibility criteria:
inclusion criteria: * be at least 18 years old and be able to read and understand spanish. * suffer a traumatic or degenerative shoulder injury, with or without surgical treatment. * have a prescription for rehabilitative physical therapy that includes active exercises. exclusion criteria: -had a concomitant injury on an upper extremity or the cervical spine at the time of participation or sequelae of previous injuries in the area.

Keywords: rehabilitation shoulder injury monitoring device adherence
a multifaceted intervention to improve hand hygiene

Conditions: Handwashing; Infection

Summary: this randomized controlled trial will evaluate the effect of a multifaceted intervention including performance feedback on adherence to hand hygiene among healthcare workers. a key component of the study is to demonstrate whether improved adherence to hand hygiene leads to a reduction in rates of infection.

a cluster randomized controlled trial of the intervention will be conducted where hospital units (wards) in three hospitals will be allocated to either the intervention or usual practise. we will stratify by hospital site in order to minimize confounding by hospital-level factors. the unit of allocation, intervention, and analysis will be at the level of the hospital unit. thirty hospital units will be randomized to either the intervention or comparison arm. we will compare adherence to hand hygiene, mrsa rates, and other outcomes between the two study arms.

Eligibility criteria:
a. study units inclusion: medical and subspecialty units, surgical units, critical care units exclusion: pediatric units, neonatal intensive care units b. healthcare workers inclusion: any hospital staff with direct patient care who are affiliated with a single unit (includes registered nurses, nursing assistants, environmental aides, allied health professionals (occupational, physical, and respiratory therapists), and some physicians c. patients clinical outcomes will be measured in patients on study units.

Keywords: hand washing cluster randomized trial performance feedback healthcare workers hand hygiene hand washing adherence
fluoxetine as a quit smoking aid for depression prone

Conditions: Cardiovascular Diseases; Heart Diseases

Summary: to test whether adding fluoxetine pharmacotherapy to behavioral cessation treatment improves the depression-prone smoker's ability to quit.

design narrative: the research was a treatment-matching study to test whether adding fluoxetine pharmacotherapy to behavioral cessation treatment improved the depression-prone smoker's ability to quit. the investigators randomized 144 smokers with a prior history of depression and 206 smokers who lack such a history to a double-blind treatment with either 60 mg fluoxetine or placebo, while they underwent cognitive behavioral treatment to quit smoking. the main study outcome was biologically verified abstinence 6 months after treatment. the administration of placebo and fluoxetine began 3 weeks before the quit smoke date and continued for 2 months post-quit date (totaling 11 weeks on drug/placebo). cognitive behavioral treatment were weekly before quitting and biweekly after quitting. there were monthly follow-up evaluations for six months after the quit date. the research tested both the selective benefit hypothesis and the generalized benefit hypothesis of fluoxetine's effects. the hypothesis of the mechanism of action was that the drug diminished compulsive smoking behavior, obsessional cigarette craving, and nicotine withdrawal dysphoria that occurred independently of depressive vulnerability. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
an estimated 144 smokers with a prior history of depression and 206 smokers who lacked such a history.
transmuscular quadratus lumborum block for postoperative pain after laparoscopic adrenalectomy

Conditions: Pain Management; Nerve Block; Laparoscopic Adrenalectomy

Summary: this prospective, randomized control study aims to compare the analgesic effect, satisfaction with anesthesia and analgesia between single-injection qlb (quadratus lumborum block)+general anesthesia (ga) and general anesthesia (ga) alone in patients undergoing laparoscopic adrenalectomy.


Eligibility criteria:
inclusion criteria: * age 18-70 yrs * american society of anesthesiologists physical statusⅰ-ⅲ * undergo laparoscopic adrenalectomy * informed consent exclusion criteria: * a known allergy to the medications being used for anesthesia * coagulopathy or on anticoagulants * chronic opioid therapy or history of substance abuse * participating in another rct * inability to properly describe postoperative pain to investigators (e.g., language barrier, neuropsychiatric disorder).

Keywords: transmuscular quadratus lumborum block adrenalectomy
belimumab corticosteroids sparing treatment in systemic lupus erythematosus

Conditions: SLE (Systemic Lupus)

Summary: belimumab, anti-blys human monoclonal antibody, is the first immunotherapy used for the treatment of systemic lupus erythematosus (sle) which was licensed in 2011 in france. currently, belimumab is reimbursed for the treatment of active slewith autoantibody-positive after intolerant or initial failure of first-line traitment (anti malaria, non-steroidal anti-inflammatory drugs, glucocorticoids and/ou immunomodulatory agents). european league against rheumatism (eular) suggest the following terminology of "low dose" when steroids are less than 7.5 mg/day (prednisone equivalent) because this dose range is often used for maintenance therapy for many rheumatic diseases requiring glucocorticoids and it is relatively few adverse effects. in patients with sle, a significant proportion of the damage could be attributed to corticosteroid therapy, and this damage accumulated over time. thanks to randomised and subgroups trials, post-hoc analysis , belimumab seems to be interesting in the maintain of lowest possible dose of glucocorticoids. however, these studies were not design with this aim, so it is impossible to conclude. thus, belimumab seems to be very interesting treatment to redcuce glucocorticoids level. we conduce a multicentric french study in real-life settings, to assess the ability of belimumab to achieve low-dose of steroids.


Eligibility criteria:
inclusion criteria: * person aged ≥ 18 years * with sle according to acr/eular criteria 2019 * started treatment by belimumab between 13 / july / 2011 to 13 / july / 2020 * following in an hospital center in poitiers, la rochelle, rochefort, niort, angoulême, nantes, rennes, tours, angers * affiliate or beneficiary of a social security scheme exclusion criteria: * persons under guardianship or curatorship or without civil law * pregnant and breastfeeding * persons who refused to participate * patients who stoppped belimumab before 6 months
caduet vs usual care in subjects with hypertension and additional risk factors

Conditions: Hypertension; Hypercholesterolemia

Summary: to investigate whether a caduet based treatment strategy might result in greater reduction in total cardiovascular risk as compared to usual care in subjects with hypertension and additional risk factors.


Eligibility criteria:
inclusion criteria: * hypertension with three additional risks factors (for example: smoking, type 2 diabetes, family history of early heart disease, history of stroke, age over 55 (men) and 65 (women) exclusion criteria: * subjects currently receiving a statin or stopped statin within 6 months prior to enrollment. * subjects with a history of myocardial infarction and subjects with coronary bypass graft or intra-coronary interventions.
paracoracoid subscapularis plane block versus iso block for shoulder surgery for shoulder surgery

Conditions: Post Operative Pain

Summary: shoulder surgery is the second orthopedic operation cause post operative pain interscalene block is the standard block for shoulder surgery but it cause phrenic nerve block and diaphragmatic hemipareses iso block is the block used to block the brachial plexuses cord and suprascapular nerve and paracoracoid subscapularis block supra scapular nerve in supra scapular fosa and axillary nerve as it curves around humeral head

two groups group s for paracoracoid subscapularis block group i for iso block twenty patients for para coracoid subscapularis block with ultra sonography 50 mm 22g needle inserted anterior to the fascia and 15ml o.5% bupivicaine injected another twenty patients for iso block a linear probe of ultrasound is placed in the infraclavicular region to identify the cords the needle is inserted 2-3cm superior to the clavicle and advanced in.plane posterior to the clavicle toward the cods and 25ml local anaesthesia is injected

Eligibility criteria:
inclusion criteria: * male or female patient \>20year for shoulder surgery american society of anaesthesiologist physical state 1 to2 exclusion criteria: * refusal of patient systemic infection local infection neurological or respiratory disease
oral microbiome and pancreatic cancer

Conditions: Pancreatic Cancer

Summary: this is a prospective population based study to examine the relationship of oral and pancreatic microbiome, and their functions, to pancreatic cancer risk. the identification of specific oral bacteria and their functional relationship to pancreatic cancer will advance scientific knowledge on the etiology of pancreatic cancer. this could provide a new microbially-based research paradigm, possibly leading to new drug targets for this disease. second, the oral bacteria may serve as a readily accessible, non-invasive biomarker for subsequent pancreatic cancer risk, which help to identify people at high risk of this disease. finally, the identified oral bacteria may lead to microbial prophylactic preventions, with antibiotic therapy aimed at eradicating the specific species associated with increased cancer risk or, alternatively, combined with probiotics to introduce species that are associated with a decreased cancer risk. thus, the study outcomes will lead to actionable means for pancreatic cancer prevention.

a history of periodontal disease and the presence of circulating antibodies to selected oral pathogens have been associated with increased risk of pancreatic cancer; however, direct relationships of oral microbes with pancreatic cancer have not been evaluated in prospective studies. investigators examine the relationship of oral microbiota with subsequent risk of pancreatic cancer in a large nested case-control study.

Eligibility criteria:
inclusion criteria: * dna extracted from oral wash samples from nih-plco and acs-cps cohorts exclusion criteria: -