Kornimate/medical-research-clean huggingface dataset:
effects of totum-448 on liver fat content, cardiometabolic risk factors and gut microbiota among participants with masld

Conditions: Non-Alcoholic Fatty Liver Disease

Summary: this clinical trial aims to investigate the effects of totum-448, a mix of 5 plant extracts and choline, consumed at the daily regimen of two times per day, on liver fat content, cardiometabolic risk factors and gut microbiota among both men and women with masld.


Eligibility criteria:
main inclusion criteria: * men and women aged between 18 and 75 years (including ranges); * cap score ≥288db/m with liver stiffness results \<8kpa (corresponding to f0 to f1 fibrosis score) assessed by fibroscan®; * bmi ≥25 and \<40 kg/m2 and wc thresholds according to the nafld nomenclature consensus group (rinella. 2023. hepatology); * weight stable within ± 5% in the last three months. main exclusion criteria: * contraindications to mri, fibroscan® and dexa; * suffering from a metabolic disorder susceptible to significantly affect glucose metabolism or plasma lipid levels or that might affect the study outcomes according to the investigator; * suffering from an uncontrolled arterial hypertension (systolic blood pressure ≥ 160 mmhg and/or diastolic blood pressure ≥ 100 mmhg); * with a history of atherosclerotic cardiovascular disease (ascvd); * taking medication which may affect the study outcomes; * alcohol consumption over ≥10 drinks/week for women and ≥15 drinks/week for men (women consuming more than 3 drinks/day and men consuming more than 4 drinks/day will also be excluded) or not agreeing to keep their alcohol consumption habits unchanged throughout the study.

Keywords: masld cardiometabolic risk factors dietary supplement plant extracts polyphenols liver fat content magnetic resonance imaging overweight obesity glucose metabolism oral glucose tolerance test insulin sensitivity insulin secretion fibroscan health-related quality of life body composition liver function
influence of pramipexole extended release on medication adherence in parkinson´s disease

Conditions: Parkinson Disease

Summary: this is an open-label, prospective post marketing surveillance study to be performed in sweden. only data of patients idiopathic pd should be documented, in whom the treating physician plans to initiate a pharmacotherapy with ppx er independent of this observational study. the questionnaires (morisky medication adherence measure, patient preference scale, cgi-i, pgi-i) will be used to document routine care in a standardized way and thus ensure high validity of the observational data. as the degree medication adherence of patients is routinely evaluated by their physicians, as is patient preference and possible symptom improvement after initiation of a new therapy, the patient questionnaires will be used to standardise medical routine care and to ensure validity of observational data.


Eligibility criteria:
inclusion criteria: 1. patients suffering from idiopathic pd who before inclusion into the observation had been planned to be treated with ppx er according to the sp, and where decision of treatment was made independently of the patients¿ inclusion into this observational study 2. stable dose of ppx ir for at least 4 weeks before inclusion into the observation 3. male or female pd patients aged at least 30 4. ability to reliably complete self-rating scales (morisky medication adherence measure, patient preference scale) according to the physician¿s judgement 5. written informed consent by the patient for study participation. exclusion criteria: 1. patients who are not able to understand the questionnaires (e.g. due to mental impairment or language problems) according to the physician¿s judgement. 2. any contraindications against ppx er according to the summary of product characteristics (spc).
improving outcomes after picu admission: a pilot study

Conditions: Critical Illness

Summary: 1. evaluate the feasibility and acceptability of an information based intervention delivered to parents following their child's admission to paediatric intensive care; 2. evaluate the feasibility and acceptability of the study design and procedures; 3. explore the effects of the intervention on parent and child psychological outcomes 3-6 months post discharge from picu; 4. explore the effects of parental stress experienced during picu admission on the effectiveness of the intervention; 5. to provide data that, combined with results from other studies, could inform the sample size for a future multi-site rct.

most children are now expected to make a complete medical recovery following admission to picu. however, research suggests that some children will go on to develop psychological difficulties, such as problems with emotions, behaviour, and learning. in addition, parents themselves may suffer with emotional difficulties. although the follow-up of survivors is recommended, there are currently no specific guidelines in place. intervention in the early stages of recovery could help families pull through without long lasting after-effects.

Eligibility criteria:
inclusion criteria: * unplanned emergency admissions to picu for at least 12 hours * parent or primary carer speaks and can read english exclusion criteria: * child dies whilst on ward * child discharged with a terminal illness * child has had multiple picu admission in the past * staff feel it is inappropriate to approach family * family live overseas

Keywords: picu critical illness outcomes mental health education randomized controlled trial (rct) pilot feasibility
clinical outcomes of indocyanine green tracer using in laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer

Conditions: Gastric Cancer

Summary: patients with resectable remnant gastric cancer were selected as study subjects to investigate the safety, efficacy, and feasibility of icg near-infrared imaging tracing in guiding laparoscopic lymph node dissection for remnant gastric cancer by comparing injection icg group and non-injection icg group.

indocyanine green tracer is often applied in surgery for gastric cancer. its application in laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer is at the stage of cases accumulation, method studying and clinical research. there is no prospective studies to identify the clinical outcomes of indocyanine green tracer using in laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer. on the basis of more than 300 cases of laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer, we want to apply the indocyanine green tracer, a cheap, easy to operate and no radiation pollution way, to predict the positive lymph nodes in remnant gastric cancer, to guid the scope of laparoscopic lymph node dissection for remnant gastric cancer.

Eligibility criteria:
inclusion criteria: 1. age from 18 to 75 years 2. remnant gastric cancer (ct1-4a, n-/+, m0 at preoperative evaluation according to the american joint committee on cancer (ajcc) cancer staging manual seventh edition) (4) no distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations (5) performance status of 0 or 1 on the ecog (eastern cooperative oncology group) scale (6) asa (american society of anesthesiology) class i to iii (7) written informed consent exclusion criteria: 1. women during pregnancy or breast-feeding 2. severe mental disorder 3. history of previous upper abdominal surgery (except for laparoscopic cholecystectomy and gastrectomy) 4. history of previous gastric surgery (including esd/emr for gastric cancer) 5. rejection of laparoscopic resection 6. history of allergy to iodine agents 7. enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging 8. history of other malignant disease within past five years 9. history of previous neoadjuvant chemotherapy or radiotherapy 10. history of unstable angina or myocardial infarction within the past six months 11. history of unstable angina or myocardial infarction within past six months 12. history of continuous systematic administration of corticosteroids within one month 13. requirement of simultaneous surgery for another disease 14. emergency surgery due to complications (bleeding, obstruction or perforation) caused by gastric cancer 15. fev1\<50% of the predicted values 16. linitis plastica, widespread

Keywords: indocyanine green tracer laparoscopic gastrectomy remnant gastric cancer
the acute effect of kinesio tape on pain, joint range of motion and dynamic balance in patients with low back pain

Conditions: Low Back Pain

Summary: the aim of this study is to evaluate the acute effect of kinesio taping on pain, range of motion and dynamic balance in patients with chronic nonspecific low back pain. 48 patients were included in the study and were randomly divided into three groups by ordinal number randomization. all patients were evaluated of pain, joint range of motion and dynamic balance before and 45 minutes after the application. kinesio taping with elastic therapeutic tape was applied to the core muscles of the study group, and the same muscles of the placebo group were taped with plaster tape in the same way, and no application was made to the control group.

the aim of this study is to evaluate the acute effect of kinesio taping on pain, range of motion and dynamic balance in patients with chronic nonspecific low back pain. 48 patients were included in the study and were randomly divided into three groups by ordinal number randomization. all patients were evaluated by the same physiotherapist in terms of pain (visual analog scale), joint range of motion (gonyometric measurement) and dynamic balance (timed up and go test) before and 45 minutes after the application. kinesio taping with elastic therapeutic tape was applied to the transversus abdominis, rectus abdominis and iliocostal muscles of the study group, and the same muscles of the placebo group were taped with plaster tape in the same way, and no application was made to the control group.

Eligibility criteria:
inclusion criteria for the study: * having low back pain of at least 3 out of 10 points on the visual analog scale, * being between the ages of 30-55, * having low back pain for at least 3 months, * having been tested with a test piece beforehand and not having an allergy to kinesio taping. exclusion criteria for the study: * having had surgery for low back pain, * not complying with treatment, * having a neurological deficit, * being pregnant, * having received any treatment for low back pain in the last month.

Keywords: kinesio tape low back pain balance joint range of motion
analysis of the genotype/phenotype relationship in the fuchs' corneal endothelial dystrophy in france

Conditions: Corneal Dystrophies

Summary: the pathophysiology of the most common corneal endothelial dystrophies (fuchs' corneal endothelial dystrophy, fecd) is beginning to be dismembered. there is a significant heterogeneity in the clinical forms and the investigators have just highlighted a great diversity of histological forms that seem to define distinct groups.

the most frequent genetic abnormalities have been published since 10 years and can now be easily searched. this study is going to analyze the relationships between clinical, histological and genetic forms in a large population to better understand how histological abnormalities are formed.

Eligibility criteria:
inclusion criteria: * affiliated with or entitled to a social security scheme * consent form to participate in the study signed * with an fecd certified by slit lamp examination * requiring an endothelial keratoplasty exclusion criteria: - patients under guardianship or curators

Keywords: corneal dystrophies corneal endothelial dystrophy fuchs' corneal endothelial dystrophy, fecd
the role of the pulmonary vasculature in the fontan circulation

Conditions: Congenital Heart Disease; Fontan Operation; Pulmonary Vascular Resistance; Pulmonary Vascular Remodeling

Summary: this study aims to explore the structural and functional characteristics of the pulmonary vasculature in adult fontan patients. objectives: * determine the effect of pulmonary vasodilatation on indexed cardiac output during simulated exercise. * characterization of structural properties of small pulmonary arteries.

rationale: the fontan circulation is a palliation for patients with a functionally univentricular heart. the fontan circulation is characterized by impaired exercise capacity and gradual attrition over time. to date treatment options are extremely limited. it has been proposed that pulmonary vascular resistance (pvr) is the controlling and limiting factor of cardiac output in the fontan circulation. remodeling of the pulmonary vasculature and increasing pvr are possible key factors in the long term failure of the fontan circulation. optical coherence tomography (oct) is an intravascular imaging modality used for structural characterization of blood vessels. nitric oxide is a pulmonary vasodilator used in pulmonary vascular response tests, aimed at lowering pvr which may improve cardiac output in the fontan circulation. these two diagnostic procedures are tools to study the structural and functional characteristics of the pulmonary vasculature in the fontan circulation. the results of this study could identify the pulmonary circulation as a future treatment target in fontan patients and may provide clues for new therapeutic treatment strategies to improve the long term outcome of these patients. study procedure: the study protocol will be performed during a clinically indicated cardiac catheterization. in the context of this study additional measurements will be performed which will include a pulmonary vascular response test, trans-thoracic echocardiography and pulmonary artery oct measurements.

Eligibility criteria:
inclusion criteria: fontan group * written informed consent * clinical indication for cardiac catheterization control group * written informed consent * clinical indication for right heart catheterization * absence of pulmonary vascular disease * normal pulmonary vascular hemodynamic profile exclusion criteria: fontan group * standard exclusion criteria for cardiac catheterization * obstruction in fontan conduit * inability to measure a reliable cardiac index and pvr (rhythm instability, hemodynamic or anatomic reasons) control group - no specific exclusion criteria apart from the standard exclusion criteria for right heart catheterization.
effects of carbidopa/levodopa/entacapone on motor function and quality of life in patients with parkinson's disease

Conditions: Parkinson's Disease With End of Dose Wearing Off

Summary: to assess motor function and quality of life (qol) in parkinson's disease (pd) subjects with end-of-dose wearing off, comparing immediate and delayed switch to carbidopa/levodopa and entacapone.

this was a prospective, multi-center, randomized, open-label study with blinded raters to evaluate the effects of immediate versus delayed switch to carbidopa/levodopa/entacapone on motor function and quality of life in patients with parkinson's disease with end-of-dose wearing off.

Eligibility criteria:
inclusion criteria: * males or females 30-80 years of age (inclusive). patients aged 81-85 years were eligible to participate if the principal investigator considered the patient to be in otherwise good health. * clinical diagnosis of parkinson's disease exhibiting two of three symptoms (rigidity, resting tremor, bradykinesia). * all patients were required to have end-of dose wearing off (eodwo, re-emergence of pd symptoms at the end of at least two daily doses of levodopa during waking hours). * taking regular doses of immediate release carbidopa/levodopa exclusion criteria: * unstable parkinson's disease requiring booster doses or treatment with as needed dose regimens of levodopa * female subjects who are pregnant, trying to become pregnant or nursing an infant other protocol-defined inclusion/exclusion criteria applied to this study.

Keywords: parkinson's disease, tremor
transbronchial mediastinal cryobiopsy combined with ebus-tbna in the diagnosis of mediastinal lesions

Conditions: Mediastinal Lymphadenopathy

Summary: the clinical study is aimed to prospectively evaluate the diagnostic accuracy and the safety of adding transbronchial mediastinal cryobiopsy to standard sampling in mediastinal diseases.

a traditional method, endobronchial ultrasound-guided transbronchial needle aspiration (ebus-tbna) was used to be compared. the patients involved were randomly divided into two groups. in the experimental group, ebus-tbmcb was performed following ebus-tbna while in the other group, ebus-tbna was performed respectively. the samples obtained in the two groups were analyzed by the pathologists. patients were followed up for confirming the diagnosis and complications. the diagnostic accuracy and prevalence of procedure-related adverse events were compared between the 2 groups.

Eligibility criteria:
inclusion criteria: * age \>=15 years; * more than one mediastinal lesions with diameter \>= 1cm was detected by thoracic ct; * indication of biopsy to identify the etiology, including recently discovered mediastinal lesions or combination of clinical respiratory symptoms and complicated lung lesions implicated by thoracic image ; * completion of necessary preoperative laboratory examination and other examinations such as cardiac ultrasound or cta when necessary, in order to exclude potential contradictions; * informed consent form achievement. exclusion criteria: * contradictions to bronchoscopy examination such as severe cardiopulmonary diseases, coagulation disorders, intolerance to anesthesia or endoscopic operation and so on; * failure to detect the mediastinal lesions in ultrasonic landscape; * cysts or abscess; * requirements for additional procedures other than ebus examination (such as endobronchial biopsy); * psychiatric disorders or severe neurosis. * participation in other clinical experiments in recent 3 months; * any other conditions considered to be inappropriate to be involved in this study.
a study of sctt11 in healthy participants and participants with thyroid eye disease.

Conditions: TED

Summary: multicentre, randomized, double-blinded, phase i/ii clinical study to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of sctt11 in healthy participants and participants with thyroid eye disease


Eligibility criteria:
inclusion criteria for healthy participants: 1. healthy male or female participants aged between18 and 45 inclusive 2. all participants must agree to not fall pregnant and voluntarily use highly effective double method contraception during the study for at least 180 days after the last dose; female participants must have a negative pregnancy test prior to dosing and must not be breastfeeding exclusion criteriafor healthy participants: 1.with any other disease or medical condition of clinical significance (e.g., past medical history of chronic hepatic, renal, cardiovascular, neurological/psychiatric, gastrointestinal, respiratory, urological, endocrinological, or other systemic diseases, etc.) as assessed by the investigator. inclusion criteria for ted participants: 1. male or female participants aged between 18 and 70 inclusive 2. participants with moderate-to-severe (has an appreciable impact on daily life and requires intervention, but is not sight-threatening) ted 3. normal thyroid function, or only mild hyperthyroidism or hypothyroidism (defined as screening free triiodothyronine \[ft3\] and free thyroxine \[ft4\] levels \< 50% above or below the normal limits). exclusion criteria for ted participants: 1. decreased best corrected visual acuity of the study eye due to optic neuropathy within 6 months prior to the first dose 2. corneal abnormalities in study eye with no relief from treatment, as evaluated by the investigator 3. a reduction of ≥2 points in the cas value or a reduction of ≥2 mm in proptosis in the study eye from the screening assessment period to study baseline period 4. presence of other ocular conditions that, in the judgement of the investigator, may affect the evaluation of the study results 5. presence of poorly controlled diabetes mellitus 6. the current presence of other uncontrolled clinical diseases or conditions 7. abnormalities in any of the following laboratory examinations during the screening phase 8. poorly controlled hypertension 9. with past medical histories of major surgery and/or trauma within 1 month prior to the first dose 10. with past medical histories of severe allergies, histories of severe drug allergies, known or suspected allergy to any component of this investigational product 11. vaccination with live or live attenuated vaccine within 1 month prior to the first dose or expected during the study 12. participation in a clinical study of any drug or device within 3 months prior to the first dose and have used the investigational product or have been treated with the device 13. pregnant, lactating females; or participants of childbearing potential who are unwilling to use effective contraception during the study and within 180 days after the last dose 14. other conditions evaluated by the investigator to be unsuitable for enrolment
study of farnesyl protein transferase inhibitor (fpti) in patients with leukemia (study p00701)

Conditions: Leukemia; Myelodysplastic Syndromes; Leukemia, Myeloid, Chronic; Blast Crisis; Leukemia, Lymphocytic

Summary: the purpose of this study is to determine the safety and tolerability of an oral farnesyl protein transferase inhibitor (sch 66336) as a single agent in patients with advanced myelodysplastic syndrome, acute myelogenous leukemia, chronic myelogenous leukemia in blast crisis, or acute lymphoblastic leukemia.


Eligibility criteria:
inclusion criteria: * pathologically documented chronic myelogenous leukemia in blast crisis, myelodysplasia, acute myelogenous leukemia, or acute lymphocytic leukemia. * life expectancy of 12 weeks or greater. * ecog performance status less than or equal to 2. * meets protocol requirements for specified laboratory values. * no manifestations of a malabsorption syndrome. exclusion criteria: * patients who have received more than three chemotherapy regimens for more than three recurrences of the disease. * poor medical risks because of nonmalignant systemic disease as well as those with active uncontrolled conditions. * patients who have received investigational therapy of any type within 30 days prior to administration.

Keywords: leukemia myelodysplastic syndromes leukemia, myeloid leukemia, lymphocytic
physical activity and chronic acquired brain injury

Conditions: Brain Injuries; Motor Activity; Quality of Life

Summary: most individuals who have survived an acquired brain injury (abi) present consequences affecting the sensorimotor, cognitive, affective or behavioural components. the conditions can vary from mild to extreme. the consequences of an abi may have a considerable impact on their functioning, and secondary conditions like depression or sedentary behaviours, so they suffer changes in their health-related quality of life (hrqol). the purpose of this project is to determine the effect of a physical activity group program on hrqol. as well as to identify factors that facilitate or act as a barrier to practice physical activity.

this study is a quasi experimental pre-post test with nonequivalent group design. there were two groups: 30 subjects with chronic abi took part in a physical activity group program designed by a sport club in madrid, spain; and 30 subjects with chronic abi which did not practice physical activity.

Eligibility criteria:
inclusion criteria: * individuals with mild to moderate chronic acquired brain injury from any cause. * being over 18 years of age. * being practice two or more sessions per week. * ability to understand and complete questionnaires in spanish. * voluntary participation in the study. * signed informed consent by the patient and/or their primary caregiver. exclusion criteria: * return to work * aphasia