Kornimate/medical-research-clean huggingface dataset:
effectiveness of pulse-based foods combined with exercise for improving components of the metabolic syndrome

Conditions: Metabolic Syndrome

Summary: the investigators specific objective is to determine the effectiveness of a pulse-based diet combined with an exercise training program for reducing the risk of metabolic syndrome in older adults. the metabolic syndrome is a cluster of risk factors that predispose one to the development of diabetes and cardiovascular disease. these risk factors include increased abdominal obesity, high blood triglyceride levels, low blood high-density lipoproteins, high blood pressure, high blood glucose and insulin levels, and increased inflammation. the investigators hypothesize that a pulse-based diet combined with exercise training will be very effective for reducing the risks of the metabolic syndrome because each intervention acts on different components of the metabolic syndrome. the design will involve a randomized single-blind cross-over for the pulse-based diet, and a single blind randomized parallel group assignment for the exercise-based intervention. 100 subjects will be randomized to receive the pulse-based diet or their regular diet for 2 months and then cross-over to receive the opposite diet for 2 months, separated by a one-month "wash out". subjects will be further randomized to exercise or "exercise placebo" groups for the duration of the trial (i.e. 5 months). the exercise intervention will involve aerobic training as this is most effective for reducing metabolic syndrome risk. dependent variables will be measured at 4 time points: baseline, after the first 2-month diet, before the second 2-month diet (i.e. after the washout) and at the end of the second 2-month diet. these variables will include: serum triglycerides, high density lipoproteins, c-reactive protein (as an inflammatory marker), glucose, and insulin, trunk body fat, and blood pressure. a composite metabolic syndrome score will be determined by converting each of these variables into z-scores and determining the mean of these z-scores. secondary variables will include other serum lipids, including low density lipoproteins and total cholesterol.


Eligibility criteria:
inclusion criteria: * men and women over the age of 50y exclusion criteria: * allergies to beans, peas, lentils, chickpeas * currently taking medication for blood lipids * currently engaged in vigorous aerobic activity greater than 2 times per week

Keywords: metabolic syndrome lipids blood pressure body composition
leucotrichia in vitiligo

Conditions: Leucotrichia

Summary: the incidence of leucotrichia has been reported to range from 9 to 48.4% of all vitiligo patients.leucotrichia is more often observed in segmental vitiligo with a very high percentage. however, further studies considering the prevalence of leucotrichia in different types of vitiligo need to be conducted.


Eligibility criteria:
inclusion criteria: * age \> 18 * vitiligo patients with/ without leukotrichia within the vitiliginous areas exclusion criteria: * age \< 18 * premature hair graying in the trunk before the age of 30
thunder-fire moxibustion therapy for chronic fatigue syndrome on shenque acupoint: a randomized controlled trial

Conditions: Chronic Fatigue Syndrome

Summary: chronic fatigue syndrome is a group of syndrome and is prevalent in adult. thunder-fire moxibustion is a commentary therapy belonged to acupuncture therapy. to evaluate the effect and safety of thunder-fire moxibustion therapy for chronic fatigue syndrome, we apply a randomized controlled trial by recruiting chronic fatigue syndrome patient as subject, applying thunder-fire moxibustion on shenque acupoint contrasted to common moxa-stick moxibustion, taking fatigue rating scale score, the content of cd3+、cd4+、cd8+、cd4+/cd8+ as evaluation indexes. the treatment time is 20-30 minutes per session, 3-4 times a week, there are totally 15 sessions.


Eligibility criteria:
inclusion criteria: * 1.clinical diagnosis of chronic fatigue syndrome, 2.age between 18 to 65 years old. 3.must be able to accept moxibustion treatment 4.never receive any treatment or has suspended treatment over 2 weeks 5.patients with good adherence, signed informed consent by themselves exclusion criteria: * 1.other primary disease caused by chronic fatigue 2.pregnancy or breast-feeding women. 3.merge in other serious diseases, such as severe damage in heart, liver, kidney ,lung or mental illness 4.has took durg for insomnia treatment 5.has received acupuncture,massage for chronic fatigue syndrome treatment 6.suffered from infectious disease
gemcitabine,vincristine and cisplatin as second line combination therapy in patients with sarcoma

Conditions: Sarcoma; Chemotherapy

Summary: the primary objective of this study is to evaluate pfs of gemcitabine,vincristine and cisplatin as second line therapy in patients with sarcoma. 40 patients will be treated into this study.


Eligibility criteria:
inclusion criteria: * give written informed consent prior to study, with understanding that the patient has the right to withdraw from the study at any time without prejudice * be female of male and ≥18 and ≤75 years of age * be ambulatory and have ecog performance status of ≤1 * have histological confirmed sarcoma * locally advanced or metastatic sarcoma who receive first-line chemotherapy. * have at least one target lesion according to the recist criteria. exclusion criteria: * pregnant or lactating women * patient has received chemotherapy drugs including gemcitabine,vincristine and cisplatin * chemotherapy within four weeks preceding treatment start * ecog ≥ 2 * radiotherapy to the axial skeleton within the 4 weeks preceding study treatment start or insufficient recovery from the effects of prior radiotherapy * participation in any investigational drug study within 4 weeks preceding treatment start * history of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix .abnormal laboratory values: hemoglobin \< 8. 0g/dl, neutrophil\< 1.5×109/l, platelet\< 100×109/l. * serum creatine \> upper limit of normal (uln) * serum bilirubin \> uln * alanine aminotransferase(alt) and aspartate aminotransferase(ast)\>5×uln * alkaline phosphatase(akp)\>5×uln * serious uncontrolled intercurrence infection * life expectancy of less than 3 months

Keywords: sarcoma gemcitabine vincristine cisplatin chemotherapy
multi-center registry for ccsvi testing and treatment

Conditions: CCSVI; Chronic Cerebrospinal Venous Insufficiency; Venous Malformations of CNS Draining Veins

Summary: patients suspected of ccsvi (chronic cerebrospinal venous insufficiency) may be tested and if appropriate treated with catheter venoplasty by an interventional radiologist in their local community who has been credentialled either by the local hospital's irb or a national irb if the procedure is done in an outpatient facility. catheter angioplasty is a long-established and accepted medical procedure, patients' insurance should but may not cover the testing or treatment.

more to follow

Eligibility criteria:
inclusion criteria: referral by patients primary treating physician for suspected ccsvi exclusion criteria: abnormal kidney function allergy to either or both of the imaging contrast agents pacemaker or other implantable device ferrous metal in or on the body claustrophobia pregnancy -

Keywords: neurodegenerative disease neurovascular disease fatigue hubbard foundation angioplasty
iphone app compared to standard riva-rocci (rr)-measurement during stress testing

Conditions: Blood Pressure

Summary: the iparr delta bp study is designed to evaluate whether a new smartphone app using the photoplethysmography signal of the inbuilt camera can measure blood pressure (bp) fluctuations with sufficient correlation compared to the goldstandard oscillometric bp measurements. investigators will recruit patients who are scheduled for a routine treadmill stress test and assess their blood pressure before and right after the test with the smartphone app and the standard bp measurements on the opposite upper extremity. pronounced bp fluctuations are encountered during vigorous activities. the primary endpoint of the iparr delta bp study is the correlation of the absolute difference of subsequent measurements between both techniques. if the relative chances of bp fluctuations are sufficiently assessed with this new device, bp fluctuations could be monitored continuously after calibration.


Eligibility criteria:
inclusion criteria: - able to give informed consent exclusion criteria: * atrial fibrillation * medical reasons why blood pressure measurement is not possible at the upper extremity (shunt, lymphedema)

Keywords: blood pressure smartphone app hypertension stress testing prevention cardiovascular risk factors
diagnosis value of sema4c in breast cancer

Conditions: Breast Neoplasm Female

Summary: breast cancer remains the most common cancer in women worldwide. early diagnosis can greatly improve the prognosis. to date, imaging examination is still the most important diagnostic and grading tool for breast cancer. semaphorin4c (sema4c) has previously been identified as a highly expressed protein by breast cancer-associated lymphatic endothelial cells (lecs). the study is undertaken to evaluate the diagnostic efficiency of sema4c.

breast cancer remains the most common cancer in women worldwide, with approximately 1.68 million new cases, and 0.52 million deaths, annually. meanwhile the incidence of breast cancer continues to increase. early diagnosis and access to optimum treatment are crucial to reduce mortality associated with breast cancer. currently, mammography and breast ultrasonography are essential for the detection and diagnosis of disease, and breast magnetic resonance imaging is the choice to estimate the extent of disease and guide appropriate treatment. however, there is no robust biomarkers for early detection of breast cancer. semaphorin4c (sema4c) has been previously identified as a highly expressed protein by breast cancer-associated lymphatic endothelial cells (lecs) using in situ laser capture microdissection of lymphatic vessels, followed by cdna microarray analysis. moreover, membrane-bound sema4c is cleaved by matrix metalloproteinase (mmps) to release a soluble form of this protein. therefore, this prospective project aims to assess the early diagnostic value of sema4c as a biomarker for breast cancer.

Eligibility criteria:
inclusion criteria: * receiving no treatment before diagnosis * establishing diagnosis according to biopsy or surgery exclusion criteria: * patients who are not mentally capable of giving written informed consent * clinical data missing * serum samples doesn't qualified * patients with a diagnosis of other severe acute or chronic medical conditions that may interfere with the interpretation of the study results
comparative genomic and genetic analysis of paired primary breast - metastatic tumor specimens using high-throughput platforms

Conditions: Breast Cancer

Summary: adequate quality and quantity of rna may be extracted from paraffin-embedded tumor blocks for gene expression analysis. this has clinical relevance as gene expression signatures may then be profiled using archival tumor blocks, which are more readily available than frozen tissues.


Eligibility criteria:
inclusion criteria: no participants are involved. exclusion criteria: no participants are involved.
pre-lens tear film performance of silicone hydrogel daily disposable contact lenses

Conditions: Myopia

Summary: the purpose of this study was to compare the pre-lens tear film stability of dailies total1® silicone hydrogel daily disposable contact lenses with that of two other silicone hydrogel daily disposable contact lenses.


Eligibility criteria:
inclusion criteria: * be of legal age of consent and sign written informed consent document, or if under legal age, have written consent of parent or guardian to participate. * require vision correction in both eyes. * wear either daily disposable contact lenses or weekly/monthly replacement contact lenses in powers between -0.50 and -10.00 diopters, cylinder ≤0.75 diopter, no add correction. * wear habitual contact lenses an average of 12-14 hours per day, at least 5 days per week. * willing and able to wear study contact lenses 16 hours per day. * able to achieve visual acuity of at least 6/7.5 in each eye with study lenses. * other protocol-defined inclusion criteria may apply. exclusion criteria: * currently wearing dailies total1®, 1-day acuvue® trueye™, or clariti™ 1day contact lenses. * require monovision correction. * any systemic or ocular disease or disorder (refractive disorder allowed and dry eye permitted), complicating factors, or structural abnormality that would negatively affect the conduct or outcome of the study. * ocular surgery/trauma within the last 6 months. * topical or systemic antibiotic use within 7 days of enrollment. * topical ocular or systemic corticosteroid use within 14 days of enrollment. * pregnant and nursing women. * participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment. * other protocol-defined exclusion criteria may apply.

Keywords: myopia contact lenses
a study to collect pre-existing data on the administration of cabozantinib in participants with advanced renal cell carcinoma (arcc) who initiated cabozantinib in 2nd line in a real-life clinical setting in france.

Conditions: Advanced Renal Cell Carcinoma

Summary: cabozantinib is an orally bioavailable tyrosine kinase inhibitor (tki) approved in patients with arcc previously treated with a vascular endothelial growth factor (vegf)-targeted therapy. cabozantinib has been increasingly used in routine care in second line and more in advanced or metastatic rcc in france. cabozantinib effectiveness and safety notably in a real-word setting are now well known, but too many questions that arise during the routine care of patients with arcc remain unanswered by the current literature. obtaining data on cabozantinib effectiveness and treatment pattern in those participants subpopulations will allow physicians to improve patients care. the aims of this study are to describe the effectiveness - in terms of duration of treatment (dot), best overall response (bor) and progression-free survival (pfs) - and the safety of second line cabozantinib a real-life setting in france and to address the unanswered questions that arise during the routine care of patients with arcc treated with cabozantinib in order to improve the care of these participants.

since 2018, cabozantinib has been increasingly used in routine care in second line and more in advanced or metastatic rcc in france. cabozantinib effectiveness and safety notably in a real-word setting are now well known, but too many questions that arise during the routine care of patients with arcc remain unanswered by the current literature. as an example, there is currently no real-world data on cabozantinib in elderly patients (≥ 75 years old); in patients with a systemic therapy after progression under cabozantinib (only one published monocentric retrospective study on 56 participants); or in long responder patients (with a disease controlled after \> 12 months of cabozantinib). obtaining data on cabozantinib effectiveness and treatment pattern in those patient subpopulations will allow physicians to improve patients care.

Eligibility criteria:
inclusion criteria: * male or female ≥ 18 age at the time of cabozantinib initiation. * pathologically confirmed diagnosis of renal cell carcinoma (rcc) considered as advanced at the time of cabozantinib initiation. * cabozantinib initiated from 1st march 2018 to 1st march 2021 for an advanced rcc. * cabozantinib initiated in 2nd line according to local summary of product characteristics (smpc). exclusion criteria: * participant medical file without documented follow-up visits (post-cabozantinib initiation). * participant alive at study initiation who is opposed to data collection. * participant who died before study initiation and who was opposed to data collection for research purposes when alive.
effectiveness of recovery protocols combination in soccer players

Conditions: Soccer; Physical Stress; Fatigue

Summary: the main objective of this project is to compare the effectiveness of combining different recovery methods on perceptual and physical performance on soccer players.

a crossover study will be performed and players will be assigned to different recovery methods combinations after their participation in a football game. the investigators will take baseline measures before the game and post-competition measures 24 hours after the game (one hour before the recovery intervention). moreover, another two measure moments will be used, 24 and 48 hours after the recovery intervention.

Eligibility criteria:
inclusion criteria: * semi-professional soccer players * 75 minutes game participation (minimum) * 5 years of experience practicing soccer exclusion criteria: * goalkeepers * injured players

Keywords: performance recovery fatigue soccer
ganglion impar block with physical therapy vs caudal epidural steroid injection with pt for patients with coccydynia

Conditions: Coccyx Disorder

Summary: the study aims to evaluate the efficacy of two treatment modalities for patients suffering from coccydynia: ganglion impar block (gib) combined with physical therapy, and caudal epidural steroid injection (cesi) also accompanied by physical therapy. coccydynia, characterized by pain in the coccygeal region, can significantly impair daily functioning and quality of life.

participants were assessed using various outcome measures, including the sf-12, oswestry disability index (odi), and numeric pain rating scale (nprs). data collection will occur at baseline and through four follow-up points over 16 weeks, allowing for a comprehensive evaluation of both immediate and long-term treatment effects. by comparing these two interventions, the study seeks to determine which approach yields superior results in alleviating pain and improving functional outcomes for patients with coccydynia, thereby contributing valuable insights into the management of this condition.

Eligibility criteria:
inclusion criteria: * adult patients with age 18-65 diagnosed with chronic coccydynia for at least 3 months were recruited. * participants who will be willing \& able to adhere to the study protocol. * including participants who will be attending follow-up appointments \& completing outcome measures. * participants who will be able to understand \& provide written informed consent. * participants with a complete screening of other medical conditions and previous medical records. exclusion criteria: * participants with previous surgery on the coccyx or lumbosacral spine, pregnancy or breastfeeding, history of bleeding disorders or anticoagulant use, active infection, or significant medical condition that could pose a safety risk during the procedures (gib or cesi) was omitted. * patients above the age of 65 were eliminated to reduce confounding by age-related health concerns and to provide a more homogenous study population for more accurate treatment outcomes. * participants with neurological conditions affecting pain perception or sensation were excluded. * participants with known allergies to medications used in the study (local anesthetic, steroid for injections) were not part of the study.
prodrome-based early intervention with antipsychotics vs. benzodiazepines in first-episode schizophrenia

Conditions: Schizophrenia; Psychoses

Summary: prodrome based early intervention with an antipsychotic drug vs. benzodiazepine was applied in patients with first episode schizophrenia after one year neuroleptic maintenance treatment. two groups of patients were followed over a period of 1 year: one further on under maintenance neuroleptic treatment, the other one after stepwise drug discontinuation.

in case of early signs of a relapse prodrome based early intervention with an antipsychotic drug (haloperidol, risperidone and other) vs. benzodiazepine (lorazepam) was applied in patients with first episode schizophrenia after one year neuroleptic maintenance treatment. two groups of patients were followed over a period of 1 year: one further on under maintenance neuroleptic treatment (haloperidol, risperidone and other) , the other one after stepwise drug discontinuation.

Eligibility criteria:
inclusion criteria: * first-episode in schizophrenia (according icd-10 f20) * age between 18 and 55 * informed consent * one year neuroleptic maintenance treatment exclusion criteria: * residence outside of the catchment area * legal reasons * insufficient knowledge of the german language * substance abuse or addiction * pregnancy * serious physical illness * organic brain disease * contraindication to neuroleptic treatment

Keywords: schizophrenia first episode prodrome based early intervention antipsychotics - benzodiazepine maintenance treatment drug discontinuation
a non interventional study to investigating the ratio of mis-diagnosed bipolar symptoms in patient with major depressive disorder (mdd)

Conditions: Major Depressive Disorder; MDD

Summary: the study will only detect hypomanic symptoms in treatment resistant mdd patients by mean of hcl-32 administration. further re-evaluation of mdd diagnosis is not a direct aim of the study. no efficacy and tolerability of pharmacological treatments will be assessed. patients matching inclusion and exclusion criteria will be enrolled consecutively; each investigator will include the first 10 to 40 patients that will be visited as treatment resistant mdd.


Eligibility criteria:
inclusion criteria: * written informed consent form * male and female age: 18-65 years * diagnosis of mdd according to dsm-iv tr (296.3 x major depressive disorder, recurrent) * treatment resistance defined as non-response to at least 2 antidepressants given in an ade exclusion criteria: * patients already participating in clinical trial or any other interventional study * patients unable to understand hcl-32 item meaning

Keywords: major depressive disorder mdd
helicobacter pylori sample collection protocol post therapy subjects

Conditions: Helicobacter Pylori Infection; Gastric Ulcer; Nausea; Abdominal Pain; Weight Loss; Stomach Ulcer; Loss of Appetite; Bloating

Summary: the primary objective is to obtain stool samples from post-therapy subjects already undergoing evaluation for an h. pylori infection by upper esophagogastroduodenoscopy (egd) and gastric biopsy.

stools will be collected and tested, at a later date, in a clinical performance study with an investigational h. pylori antigen assay. this study will be coordinated by the sponsor.

Eligibility criteria:
inclusion criteria: * adult ≥ 22 years, either gender * subject previously diagnosed with h. pylori infection * subject received and completed fda approved treatment option * minimum of 4 weeks to one year has lapsed after completion of fda approved treatment option * subject with a post therapy positive result from a fda cleared ubt or fda cleared fecal antigen test * subject will undergo egd and gastric biopsy as part of routine care to measure h. pylori post-therapy response * biopsy is obtained from antrum and/or corpus and is tested by crm * at least two of the three crm tests are performed * subject whose egd with biopsy occurred ≤ 7 days prior to stool collection * willing and able to sign the irb approved informed consent form for this study project exclusion criteria: * subject with current severe h. pylori infection * subject ingested compounds that may interfere with detecting of h. pylori, e.g. 4 weeks for antibiotics and 2 weeks for bismuth preparations or proton pump inhibitors prior to collection * pregnant or lactating * inability or unwilling to perform required study procedures * subject is unable or unwilling to provide informed consent