Kornimate/medical-research-clean huggingface dataset:
rtsms and body weight-support treadmill training after incomplete spinal cord injury

Conditions: Spinal Cord Injuries (SCI)

Summary: the aim of this study is to assess the feasibility of combining rtsms with bwstt for gait and sensorimotor recovery in individuals with incomplete spinal cord injury.

a randomized, sham-controlled, triple-blinded and parallel group trial (10 therapeutic sessions). active or sham rtsms will be combined with body weight-support treadmill training to verify the improvement of gait and sensory-motor function in patients with incomplete spinal cord injury. assessments will be performed before, after 5 and 10 therapeutic sessions, though: (i) the wisci-ii index; (ii) asia impairment scale (ais), (iii) asia lower extremities motor scale (lems), (iv) ashworth modified scale; (v) the functional independence measure (scim-iii), (vi) the short form health survey 36 (sf-36) and (vii) the patient global impression of change scale - (pgics).

Eligibility criteria:
inclusion criteria: * diagnosed incomplete spinal cord injury established by a neurologist * chronic phase (\>1 year) * 18 and 60 years old, regardless of sex exclusion criteria: * community ambulators * could not maintain an orthostatic position for 30 seconds without assistance * associated neurological and/or orthopedic conditions * contraindications for rtsms * diagnosis of cardiac dysfunction, angina, or hemodynamic disorders

Keywords: spinal cord injury gait body weight- support treadmill training repetitive trans-spinal magnetic stimulation trans-spinal magnetic stimulation
immuno-persistence study of a recombinant human papillomavirus 16/18 bivalent vaccine in preadolescent girls (54m)

Conditions: Cervical Intraepithelial Neoplasia; Cervical Cancer; Vaginal Intraepithelial Neoplasia; Vulvar Intraepithelial Neoplasia; Persistent Infection

Summary: the primary objective of this study is to evaluate the immuno-persistence (type specific igg antibody) of the tested vaccine administered in girls aged 9-17 years,comparing to young healthy adults of 18-26 years who received the standard 3-dose schedule (0,1,6 months).

this is a follow-up study that is based on the bridging study of a recombinant human papillomavirus 16/18 bivalent vaccine in preadolescent girls(unique protocol id:hpv-pro-006,identifiers: nct02562508) .the investigators will recruit people who have participated in bridging study before and collect their serum samples to test the seroprevalence and geometric mean concentrations of anti-hpv16 and anti-hpv18 antibody on 54 months after dose 1

Eligibility criteria:
inclusion criteria: 1. participants who participated in the bridging study of a recombinant human papillomavirus 16/18 bivalent vaccine in preadolescent girls (unique protocol id: hpv-pro-006, identifiers: nct02562508) and received at least one dose; 2. participants or participants and their legal guardians can fully understand the study content and sign an informed consent form； 3. able to comply with the requests of the study; exclusion criteria: 1. participants with coagulation dysfunction (such as coagulation factor deficiency, blood-clotting disorder, or platelet disorder) or coagulation disorders, as diagnosed by a physician after vaccination ; 2. according to the investigator's judgment, there might be some medical, psychological, social or occupational factors which might impact on the individual to obey the protocol or sign the informed consent; 3. abnormal blood clotting function or coagulopathy

Keywords: human papilloma virus 16 human papilloma virus 18 adolescent girl non-inferiority immuno-persistence
molecular diagnosis of syndromic or isolated severe intellectual disability using whole exome sequencing : a pilot study

Conditions: Severe Intellectual Disability

Summary: evaluation of diagnostic whole exome sequencing in patients with syndromic or isolated severe intellectual disability without a molecular diagnostic, with suspected autosomal recessive inheritance, allowing accurate genetic counseling in this high risk of recurrence group of diseases


Eligibility criteria:
inclusion criteria: * clinical diagnosis of syndromic or isolated severe intellectual disability (iq \<50) without a molecular diagnosis * recurrence in siblings (multiplex families) suggesting autosomal recessive inheritance (with or without parental consanguinity) or sporadic cases from a consanguineous union * conventional genetic tests performed (including array-cgh) and mri/ct-scan available * dna samples from parents and from both unaffected or affected siblings available, for parental segregation and confirmation of candidate variations identified. * availability of a signed informed consent * to be affiliated or beneficiary of french social security/healthcare system exclusion criteria: * parents in the exclusion period of another study or as provided by the national register of volunteers * high-probability diagnostic hypothesis for which a molecular test is available at lower cost than exome sequencing

Keywords: whole exome sequencing molecular diagnostic genetic counselling
hyperbaric oxygen therapy in diabetics with chronic foot ulcers and improvement of quality of life

Conditions: Diabetic Foot Ulcer; Diabetes

Summary: this study evaluated the effect of hyperbaric oxygen therapy (hbot) on wound healing, inflammation index, glycemic control, amputation rate, survival rate of tissue, bacterial wound cultures, and quality of life (qol) in diabetic foot ulcer (dfu) patients with diabetes.

objective - this study evaluated the effect of hyperbaric oxygen therapy (hbot) on wound healing, inflammation index, glycemic control, amputation rate, survival rate of tissue, bacterial wound cultures, and quality of life (qol) in diabetic foot ulcer (dfu) patients with diabetes. research design and methods - this study was a randomized, single-center clinical trial. the effects of hbot on patients in the experimental group were compared with the control group received only routine care. hbot was carried out in a hyperbaric chamber for 120-min per session, five days a week for four consecutive weeks (20 treatment sessions). data were collected at 4 segments: pre-treatment (before first administration of hbot; t1), during treatment (at the tenth administration of hbot; t2), post-treatment (at the twentieth administration of hbot; t3), and treatment follow-up (two weeks after the last therapy ended; t4).

Eligibility criteria:
inclusion criteria: * over 20 years of age * a history of diabetes and a diagnosis of diabetic foot * a wound classification of grade 3 or below * clear conscious and willing to participate in this study * a signed consent form exclusion criteria: * less than 20 years of age, unwilling to participate

Keywords: hyperbaric oxygen therapy diabetic foot ulcer wound healing inflammation glycemic control amputation bacterial infection quality of life
clinical trial of human allogenic culture-expanded bone marrow-derived mesenchymal stem cells

Conditions: Heart Failure, Systolic

Summary: this clinical study will utilize allogenic bone marrow-derived culture-expanded msc that are expanded from mesenchymal stem cells and delivered using the investigational helix transendocardial delivery catheter as a therapy for ischemic hfref with reduced ejection fraction.

chronic heart failure is in need of new therapies. over the past few years, cardiovascular regenerative medicine using bone marrow-derived cells has emerged as a new treatment strategy that could have tremendous benefit in treating heart failure. at present, several types of adult bone marrow derived stem cells hold great promise to treat heart failure. allogenic culture-expanded bone marrow-derived human mesenchymal stem cells (msc) are the subject of the current study as having potential to provide a safe and effective treatment for patients with ischemic heart failure. mesenchymal stem cells are multipotent stromal cells that can differentiate into a variety of cell types, including osteoblasts (bone cells), chondrocytes (cartilage cells), myocytes (muscle cells) and adipocytes (fat cells which give rise to marrow adipose tissue). the cardiallo cell therapy is an allogenic bone marrow-derived cell treatment which is delivered intramyocardially using the investigational helix delivery catheter. the purpose of this study is to determine the safety, optimal dose and efficacy of cardiallo cell therapy system in patients with ischemic heart failure with reduced ejection fraction (hfref). phase i is designed to determine effective dose and phase ii is designed to evaluate effectiveness for improving clinical outcomes.

Eligibility criteria:
inclusion criteria: * new york heart association (nyha) class ii or iii * diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction * left ventricular ejection fraction between 20% and 40% * on stable, guideline-directed medical and device therapy, as appropriate * ntprobnp level of \>500 pg/ml. * have inflammation \> 2 mg/l as measured by high-sensitivity c-reactive protein (hs-crp) test. exclusion criteria: * other cardiovascular or medical history parameters, as appropriate, that may preclude safe administration of the study treatment.
immunogenicity and safety of a combined vaccine to prevent measles, mumps, rubella and chickenpox diseases

Conditions: Mumps; Varicella; Rubella; Measles

Summary: this is a study to evaluate the immunogenicity and safety of glaxosmithkline (gsk) biologicals combined measles-mumps-rubella varicella candidate vaccine given to healthy children in their second year of life.

separate injections of the licensed priorix (mmr vaccine) and varilrix (chickenpox vaccine) serve as control.

Eligibility criteria:
inclusion criteria: * a male or female subject between 11-13 months of age (i.e. from 11 month birthday until the day before the 14 month birthday) at the time of the first vaccination. exclusion criteria: * history of previous measles, mumps, rubella and/or varicella vaccination or disease, or known exposure to any of these diseases within 30 days prior to the start of the trial * planned administration of a vaccine not foreseen by the study protocol from 30 days prior to each vaccination until 42-56 days after each vaccination

Keywords: prophylaxis measles, mumps, rubella and chickenpox
perioperative smoking cessation trial

Conditions: Smoking (Tobacco) Addiction; Smoking Cessation

Summary: prevent is a multicentre, 2x2 factorial, randomized clinical trial that aims to determine the effect of cytisine versus placebo, as well as the effect of video messaging to support smoking cessation versus standard of care in perioperative patients. this trial aims to investigate the effects of cytisine and text messaging on 6-month continuous abstinence rates. prevent will also assess secondary outcomes at 30 days, 56 days and 6 months post-randomization: 7-day point prevalence abstinence, urge to smoke, time to first lapse, time to relapse, number of cigarettes smoking if still smoking, pulmonary complications, vascular complications, wound and infectious complications, stroke, time in hospital and acute hospital care.


Eligibility criteria:
inclusion criteria: 1. are ≥18 years of age 2. are scheduled to undergo surgery within 28 days 3. are a current smoker and not currently using any smoking cessation treatment and, 4. have a smart mobile phone with an active, up to date data plan and with internet access 5. provide informed consent to participate. exclusion criteria: 1. are pregnant or breastfeeding or expecting to become pregnant during the study follow-up period 2. are deemed unreliable for study procedures or follow-up 3. have a documented allergic reaction to cytisine, or its components (non-medicinal ingredients) or to the non-medicinal ingredients of the placebo. 4. had myocardial infarction, unstable angina, or stroke/transient ischemic attack within the preceding 2 weeks. 5. will have surgery with expected nil intake by mouth for 2 or more days 6. have previously participated in prevent 7. have a known diagnosis of untreated pheochromocytoma; schizophrenia/bipolar psychiatric illness and currently psychotic; currently having suicidal ideation or risk of suicide as determined by the site physician, known history of moderate to severe depression; currently uncontrolled severe hypertension (≥180/120 mmhg) despite treatment; known history of uncontrolled hyperthyroidism (thyrotoxicosis), severe renal impairment i.e., creatinine clearance of less than 30 ml per minute (cockcroft- gault equation) or receiving long-term dialysis, or known diagnosis of severe liver disease as determined by the site physician or documented in the clinical history.
self-management interventions for long covid-19

Conditions: COVID-19

Summary: the purpose of this study is to investigate and compare the feasibility and efficacy of two group-based interventions (education vs. mindfulness) to help self-manage long-covid symptoms.

after a covid-19 infection, more than 75% of patients report ongoing somatic, cognitive, and psychiatric symptoms. at this time, research is needed to help develop treatments that limit the impact of these symptoms on people who have had covid-19. the present study investigates the feasibility and efficacy of two group-based interventions in a single-centre, 3-arm, pragmatic rct comprising (i) an education intervention group arm, (ii) a mindfulness skills intervention group arm, and (iii) a no-treatment control group arm. phase 1 is a pilot rct and will employ a mixed methods design with qualitative post-treatment interviews in a subset of participants in the education intervention group arm only. phase 2 is a full-scale, quantitative-only rct, with refinements and power analysis based on the results of phase 1. sessions of both groups are delivered by licensed therapists and clinicians. sessions last 1.5 hours per week for 8 weeks, with 10-15 patients/group in an online format. the education group participants will learn about the nature of long-covid symptoms and discuss strategies for self-care/self-management of symptoms in recovery. the mindfulness skills intervention group participants will receive an introduction to some basic mindfulness skills and practice strategies such as mindfulness of breath, body, sounds, thoughts, and choiceless awareness.

Eligibility criteria:
inclusion criteria: * clinically diagnosed long-covid plus pcr positivity with and without hospitalization * 3-12 months post-diagnosis of covid-19 * \>2 self-reported persisting symptoms in \>1 mood, cognitive and/or somatic symptom domain * age \>18 * english speaking * private access to computer/internet exclusion criteria: * acute ventilator support * diagnosed dementia * past/present history of psychotic illness or mania and, because of potential overlap in symptoms, diagnosis of chronic fatigue syndrome, fibromyalgia, chronic lyme disease or traumatic brain injury * long-covid symptom severity (i.e., physical, cognitive, emotional symptoms) at a level that would significantly interfere with attendance/adherence to the intervention protocol

Keywords: long-term effects self-management group therapy telerehabilitation
multicenter comparative study of the activity of the medial prefrontal cortex in vulnerability to depression

Conditions: Major Depression

Summary: to examine whether the medial prefrontal cortex displays an increased activity during self-referential processing among remitted depressed patients compared to healthy controls


Eligibility criteria:
inclusion criteria (patients) * history of at least one major depressive episode * in clinical remission for at least 6 months (bdi-21 ≤ 10 \& montgomery and asberg depression rating scale ≤ 7) * aged 20-65 exclusion criteria : * first depressive episode after the age of 59 * last episode treated by cognitive behavior therapy * currently receiving a antipsychotic or mood-stabilizing drug * personal history of: major depressive episode with psychotic features, other axis-i disorder (except generalized anxiety disorder), substance-related disorder (except nicotine dependence), bipolar disorder * first-degree familial history of bipolar disorder * cognitive impairment due to another central nervous system disease * contra-indication to mri * pregnancy * refusal to be informed of abnormal findings during the mri

Keywords: depression
study of hispanics to assess risk prevention in prehypertension

Conditions: Pre-Hypertension

Summary: the purpose of this study is to assess the efficacy of lifestyle modification in reducing blood pressure values in hispanics at risk for hypertension.

in this study participants (who have prehypertension as defined as systolic blood pressure - the upper number- 130-139 mmhg and diastolic blood pressure 85-89mmhg- the lower number-) are randomly assigned to one of two groups: the minimal intervention group- participants receive advice and printed guidelines only but no counseling or personalized instruction, or the enhanced intervention group- participants receive advice and the same printed guidelines as the minimal intervention group, together with dietary and physical activity counseling provided by a dietician and/or coordinator, periodic professional reviews of their progress and personalized instructions.

Eligibility criteria:
inclusion criteria: * hispanic men and women age 18 or older * mean baseline sbp 130-139 mmhg and dbp 85-89 mmhg on screening visits 1\&2 * subjects who have access to a telephone * subjects who have read, signed and received a copy of the informed consent form prior to the initiation of any study procedures and who agree to participate in all aspects of the study * subjects who are willing and capable of complying with the requirements of the study exclusion criteria: * bmi \> 35 * pregnant or breast feeding * currently taking any anti-hypertensive medications * history of cardiovascular disease (stroke, mi, pci, cabg) * current symptoms of angina or peripheral vascular disease by rose questionnaire * fasting glucose ≥ 126mg/dl) or a history of diabetes and use of antidiabetic medication * use of oral corticosteroids \> 5days/month on average * consumption of more than 21 alcoholic drinks per week or consumption of 6 or more drinks on one occasion twice or more per week in the past 3 months prior to screening visit * use of weight loss medications (prescription or over the counter) in the past 3 months prior to screening visit 1 or body weight change \> 15 pounds in the 3 months prior to screening visit * currently undergoing or planning to undergo treatment for a neoplastic disease * clinical significant laboratory test results that are indicative of a serious medical condition * renal insufficiency (gfr\<60ml/min as estimated using cockcroft -gault formula) * any orthopedic or rheumatologic problems that might limit a subject's ability to participate in the physical activity component of the intervention * any medical condition which in the judgment of the investigator places the subject at risk due to his/her participation in the study, is likely to prevent the subject from complying with the requirements of the study or completing the study or which may jeopardize the evaluation of efficacy or safety * planning to leave area prior to the anticipated end of participation * current participation in another research study

Keywords: pre hypertension lifestyle modification dash diet
triple assay of rectal mucus in the diagnosis of colorectal cancer

Conditions: Colorectal Cancer; Adenoma Colon Polyp

Summary: development of a multiomics assay for use on oricoltm sampled rectal mucus for detection of cancer and significant polyps in symptomatic patients on the colorectal urgent suspected cancer pathway.

the primary objectives of the study are: 1. confirm the presence of established genetic, epigenetic and microbiome based biomarker signatures associated with crc and high-risk adenoma (defined as \>10mm in diameter or the presence of high-grade dysplasia) in colorectal urgent suspected cancer referrals, who are triaged for colonoscopy. 2. to expand and refine the genomic, epigenetic and microbiome biomarker signature profiles associated with colorectal cancer and high-risk adenoma to identify rarer biomarkers in addition to those previously established. 3. to generate indicative performance metrics, including an assessment of discriminatory power, sensitivity, specificity and negative predictive values for the clinical application of oricol™ multiomics assay. the secondary objectives of the study are: 1. to assess the health economics of delivering a diagnostic service to patients referred to the urgent suspected cancer (usc) pathway via a community diagnostic centre (cdc) in comparison to the current delivery mechanisms through the two-week wait (tww) pathway.

Eligibility criteria:
inclusion criteria: 1. patients 18 years and over 2. patients referred from primary care to the 'urgent suspected cancer' crc pathway during the study period. 3. patients who provide voluntary written informed consent to participate in the study. exclusion criteria: 1. patients who are unable to undergo digital rectal examination (dre). 2. patients with peri-anal/anal symptoms that may limit dre and proctoscopy examination and it would be clinically inappropriate to attempt to assess these patients. this may include conditions such as: * patients who have undergone radiotherapy. * an acute or chronic anal fissure * perianal haematoma * acute thrombosed haemorrhoids * post- operative anal stenosis * the presence of an obstructing anal/low rectal tumour or discomfort as a result of previous pelvic radiotherapy 3. current pregnancy or suspicion of pregnancy.

Keywords: colon rectum mucus adenoma microbiome
a study of experimental medication bms-986036 given to healthy participants

Conditions: Hepatic Cirrhosis; Liver Fibrosis; Nonalcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis

Summary: this is a study of experimental medication bms-986036 given to healthy participants.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * healthy participant, as determined by no clinically significant deviations from normal in medical history, physical examination, ecgs, and clinical laboratory determinations * bmi of 18 to ≤ 40 kg/m2 exclusion criteria: * presence of any factors that would predispose the participant to infection (eg, extensive periodontal disease that warrants surgical or medical treatment, unhealed open wounds) * any bone trauma (fracture) or bone surgery (i.e. hardware placement, joint replacement, bone grafting, or amputation) within 3 months of study drug administration * known or suspected autoimmune disorder, excluding vitiligo * any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status * any significant acute or chronic medical illness * current or recent (within 3 months of study drug administration) gastrointestinal disease * any major surgery within 6 weeks of study drug administration * history of diabetes mellitus other protocol defined inclusion/exclusion criteria could apply