Kornimate/medical-research-clean huggingface dataset:
clinical study to investigate the sleep quality enhancing effect of gaba

Conditions: Sleep Disturbance

Summary: the purpose of this study is to investigate the efficacy and safety of dietary supplement gaba in subjects with mild, transient sleep disorder.

the subjects will take gaba or placebo capsule once daily before sleep for 14 days.

Eligibility criteria:
inclusion criteria: * male and female subjects older than 19 years old * who is experiencing mild, transient sleep disturbance (pittsburgh sleep quality index ≥ 5, insomnia severity index ≥ 8) * who voluntarily agreed to participate in the study and signed an informed consent form. exclusion criteria: * who is suffering from severe sleep disorder including sleep disorders due to psychological or neurologic causes. * who has used sleeping pills or sleep related dietary supplements within 4 weeks before study participation * who is suffering from obstructive sleep apnea. * who has used or is expected to inevitably use prohibited concomitant medications during the study. * women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives. * who has dosed other study medications within 30 days before screening. * who is determined ineligible for study participation by investigators for any other reasons.
the potential for hpv self-testing to promote participation in cervical screening

Conditions: Cervix Diseases

Summary: to explore the potential for vaginal self-sampling to increase participation in cervical screening, we offer the option of self-sampling to a group of non-participants in cervical screening (intervention), in addition to the routine screening (smear) test. women in the control group will only receive the routine screening invitation letter. the total screening uptake rate, 2 months since the recruitment in each group will be compared.

the aim of this research is to assess the feasibility of making vaginal self sampling available to women who have declined smear testing (defaulters), through the nhs to prevent cervical cancer. we plan to identify all defaulters living in coventry between 30 and 40 years (n≈6000) from the cervical screening call-recall system. they will be randomized 1:1 to intervention and control arms. women in the control arm will be sent a routine screening letter reminding them to have a smear test. women in the intervention arm will be given the option of self-sampling for hpv testing, if they do not wish to have a smear test. they could order a self-hpv test by returning a slip in the pre-paid envelope. we then send the woman a vaginal self-collection kit. self-collected sample will be returned to the laboratory for hpv testing. whilst hpv positives (10-15%) will be advised to have a smear test, hpv negatives will be advised to accept their next smear test invitation.

Eligibility criteria:
inclusion criteria: * all cervical screening programme defaulters living in coventry exclusion criteria: 1. pregnancy 2. total hysterectomy (abdominal/laparoscopic/vaginal) 3. never been sexually active/ intimate 4. women who cannot give valid, informed, written consent 5. hpv self-sample returned without a signed consent form 6. women who request the research team to be excluded from the trial 7. women who have written to the screening services to record their refusal to take part in the nhscsp 8. women who are identified as becoming pregnant or undergoing hysterectomy following the initial test will be excluded from the analysis of data for secondary outcomes
performance evaluation of sars-cov-2 (covid-19) antigen rapid test

Conditions: SARS-CoV-2; Covid-19; Coronavirus

Summary: the sars-cov-2 antigen rapid test is a bioassay intended for rapid point-of-care detection of the sars-cov-2 virus. performance of the sars-cov-2 antigen rapid test assay will be assessed by comparison to a reference method.

the clinical performance of the sars-cov-2 antigen rapid test was evaluated in a prospective clinical study conducted at a single (1) clia waiver investigational site in miami, florida, u.s. consenting patients of any age, gender, or race/ethnicity who presented at the test site with covid-19 like symptoms during the 2021 covid-19 season were sequentially enrolled and tested. five (5) minimally trained operators with little laboratory experience and who received no training on use of the sars-cov-2 antigen rapid test and were, therefore, representative of the intended users performed the study test evaluations. a subject's participation in this study will consist of a single visit. following the completion of the informed consent process and a review of inclusion/exclusion criteria to determine eligibility, each subject will receive a unique study identification number.

Eligibility criteria:
inclusion criteria: 1. up to 200 subjects will be screened, consented, and enrolled to obtain a minimum of 60 eligible candidates. in order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. provision of informed consent 2. subject is a suspected case of covid-19 by clinical criteria: a patient with acute respiratory tract infection (sudden onset of at least one of the following: cough, fever, shortness of breath, fatigue, decreased appetite, myalgia) and with no other etiology that fully explains the clinical presentation, with or without a history of close contact with a confirmed or probable covid-19 case in the 14 days prior to onset of symptoms. 3. subject is an appropriate candidate for nasopharyngeal sample collection. d/. subject is willing to provide nasopharyngeal swab samples. exclusion criteria:an individual who meets the following criterion will be excluded from participation in this study: 1. individuals who present with 10 or greater days of covid-19 related symptoms, (fever, cough, fatigue, decreased appetite, shortness of breath, myalgia) or post-defervescence and/or convalescence.

Keywords: poc antigen
role of calcium chloride injection in alleviating atrial fibrillation post cabg

Conditions: Atrial Fibrillation

Summary: this study hypothesize that injecting calcium chloride (cacl2) into the major atrial ganglionated plexus (gps) during on pump coronary artery bypass graft (cabg) can reduce the incidence of post operative atrial fibrillation in the first 7 days after surgery.the study is designed to be prospective interventional study two armed rct for on pump cabg patient. the intervention arm will be injected with calcium chloride in the four major atrial ganglionic plexus the control arm will be injected with sodium chloride to determine the effect of calcium chloride on post cabg atrial fibrillation

this study hypothesize that injecting calcium chloride into the major atrial ganglionic plexus (gps) during on pump coronary artery bypass graft (cabg) can reduce the incidence of post operative atrial fibrillation by calcium-induced autonomic neurotoxicity, the incidence of post operative atrial fibrillation can be reduced by suppressing the function of the major atrial gps and the surrounding neural network that play an important role in initiating post operative atrial fibrillation. the study is designed to be prospective interventional study two armed rct for on pump cabg patient. the plan of work will include dividing the patients into 2 randomized control groups in the intervention group patients will be injected with 5% calcium chloride in the 4 major atrial ganglionic plexus the other arm will be coronary artery bypass graft patients who will be injected with sodium chloride 0.9% to compare the two groups to evaluate to evaluate the effect of calcium chloride in post cabg atrial fibrillation between the 2 arms of the study.

Eligibility criteria:
inclusion criteria: 1) patients more than 18 years old 2 ) patients undergoing on pump cabg exclusion criteria: 1. patients \>75 years of age 2. patients with pre operative atrial fibrillation 3. patients with significant valvular disease 5. ejection fraction \<30% 6. combined surgery of any kind 7. congenital heart disease 8. abnormal severe liver or kidney dysfunction. 9. patients undergoing off-pump cabg 10. poorly controlled hyperthyroidism 11. refusal to enrollment.

Keywords: atrial fibrillation calcium chloride on pump coronary artery bypass graft
divestment for artery-involved pancreatic cancer

Conditions: Pancreatic Cancer; Locally Advanced Pancreatic Cancer; Neoadjuvant Therapy; Borderline Resectable Pancreatic Cancer

Summary: pancreatic cancer is the most lethal malignancy of human being. surgery is the only potential cure of pancreatic cancer. the invasion of major abdominal arteries is one of the most important factor restricting surgical intervention. for artery-involved pancreatic cancer (ai-pc) patients, pre-operative adjuvant therapies, especially the neoadjuvant chemotherapy, has brought exciting postoperative survival. yet due to the potential screening effect of this treatment strategy, nearly half of ai-pc patients failed to benefit from surgery because of disease progression, adverse reactions of adjuvant treatment and other reasons. artery divestment for the treatment of ai-pc firstly reported by our center, can significantly increase resection rate and produce overall survival benefit in some patients. this study is to explore whether up-front surgery with artery divestment combined curative pancreatectomy or the chemotherapy-first strategy would be more beneficial for ai-pc patients' survival. subjects will be randomized to treatment group either receiving up-front artery divestment combined pancreatectomy (surgery group) or adjuvant chemotherapies (chemo group). in surgery group, an artery divestment combined pancreatectomy will be performed if no pre-operative contra-indication or intra-operative metastasis were revealed. post-operative adjuvant chemotherapies were prescribed according to performance status. in chemo group, adjuvant chemotherapy of gemcitabine or gemcitabine + cisplatin will be utilized according to performance status. after 2 circles of adjuvant chemotherapies, patients will be reevaluated and curative operation would be attempted if without disease progression. overall mortality at one year after randomization will be the primary endpoint. other parameters as overall survival after 2 and 3 years, median survival, disease-free survival, margin status of subjects receiving curative surgery, etc. will also be observed.


Eligibility criteria:
inclusion criteria: 1. diagnosed with pancreatic cancer staged at ct4nxm0(ajcc cancer staging manual, 8th edition) based on contrast enhanced ct\&mri scan and tumor markers; 2. age \> 18 year and \<80 year; 3. agree to participate in the study with signed informed consent. exclusion criteria: 1. evidence of metastasis based on physical examination, enhanced ct or enhanced mri; 2. poor performance status and/or co-morbidity precluding pancreatectomy and chemotherapy; 3. focal vessel narrowing or contour irregularity revealed by radiology examinations; 4. economic situations cannot afford designed treatment.

Keywords: artery divestment technique locally advanced pancreatic cancer neoadjuvant therapy borderline resectable pancreatic cancer
oral ginkgo biloba and narrow band uvb in the treatment of vitiligo

Conditions: Vitiligo

Summary: vitiligo is a common chronic skin disease with 1-4% prevalence. it has a significant psychosocial impact on patients and society. different treatment modalities with variable success rates are available. phototherapy is among the successful treatments but gives modest results. some reports documented the usefulness of ginkgo biloba (gb) when used alone in vitiligo treatment.

adding gb to phototherapy, especially the most commonly used one; narrow-band uvb (nbuvb) might give better results than using either one alone. this might improve repigmentation as well as patients' quality-of-life. (qol). this will be a prospective double-blind randomized controlled clinical trial. one-hundred-sixty vitiligo patients will be randomly divided into 2 groups( 80 patients per group). one group will receive oral gb (2 tablets of 60 mgs twice daily) with nbuvb twice weekly. the other group will receive placebo tablets( identical in size, shape and color) to gb twice daily with nbuvb twice weekly. both groups will be treated for 6 months. standard protocol of phototherapy will be used for both groups. our aim here is to see whether adding gb to nbuvb will lead to better repigmentation than placebo or not.

Eligibility criteria:
inclusion criteria: * any vitiligo patient (age 12 years and above) with non-segmental vitiligo. * body surface area (bsa) involvement ≥ 3%. exclusion criteria: * unable to consent * any topical, systemic or phototherapy for vitiligo in the previous 2 months. * pregnancy, breast feeding. * liver or kidney disease. * epilepsy * bleeding disorder or anticoagulant treatment

Keywords: phototherapy gingko biloba repigmentation
an efficacy, safety, and pharmacokinetics study of beloranib in obese subjects with prader-willi syndrome

Conditions: Obesity; Over-weight; Prader-Willi Syndrome

Summary: the purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics for certain doses of beloranib in obese subjects with prader-willi syndrome.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of prader-willi syndrome due to chromosome 15 micro-deletion, maternal uniparental disomy, or imprinting defect * bmi ≥25 kg/m2 * type 2 diabetes mellitus is allowed * subject must agree to stay at the group home or under supervision of the group home or site staff (i.e. no home visits) for the duration of the study * stable body weight during the past 3 months, except for during home visits exclusion criteria: * use of weight loss agents in the past 3 months * type 1 diabetes mellitus * current or anticipated chronic use of narcotics or opiates

Keywords: beloranib zgn-440 zgn-440 for injectable suspension zgn-433
evaluation of effectiveness of nutritional practical counseling for elderly patients at risk of malnutrition on nutritional status at home

Conditions: Malnutrition

Summary: at hospital, short term actions are used (adaptation of meals, oral supplementation...) to fight malnutrition. oral supplementation can have a positive impact on weight gain. but actions should continue at home, particularly to maintain autonomy for elderly. the hypothesis is that practical workshop about enrichment and interest of foods can help malnourished patients to change their eating habits. the main goal of this study is to evaluate the effects of this workshop on improving nutritional status, measured by mini nutritional assessment

this is a mono center cohort study of a 4-months follow-up on elderly patients after hospitalization. nutritional parameters and evaluation of the quality of life will be collected during hospitalization and output during a visit at 4 months at home. these parameters will be studied in two groups : nutritional workshop vs usual dietary counseling

Eligibility criteria:
inclusion criteria: * malnourished patients or at risk of malnutrition * coming back home after hospitalization * affiliated to a social security system * having given free, informed written consent exclusion criteria: * mini mental score \<18 * incapacitated adults and psychiatric inpatients * diet indication requiring strict salt restriction * severe swallowing difficulties * patients with artificial nutrition (enteral or parenteral) * impossibility to measure weight at home * severe digestive or intestinal malabsorption * iterative nausea and vomiting * patients with rapidly progressive diseases (life expectancy less than 6 months)

Keywords: malnutrition aging diet therapy
comparison of different refraction measurements in adults

Conditions: Vision Loss Night

Summary: the combatant is likely to carry out missions any time, any place, day or night. the very strong degradation of natural vision performance in these conditions justifies the use of visual replacement means, based on optronic sensors whose sensitivity is more adapted to these luminous environments than that of the human eye. the duration and repetition of missions carried out with night vision sensors lead to visual complaints from users. the literature on night vision binoculars adjustment states that a binocular adjustment of the equipment provides more convex settings. the latter would then limit the strain on the accommodative component, which is one of the possible sources of operator visual fatigue. in order to allow a more appropriate adjustment, it is proposed to rely on a measurement of the refraction (optical defect of the eye) of each operator. like binocular adjustments, binocular refractive methods would limit accommodative stimulation and thus visual fatigue. however, these methods are little used in favour of conventional methods. it is therefore necessary to evaluate the interest of binocular refraction for the adjustment of night vision binoculars. the purpose of this study is to compare refraction measurements by procedure in adult subjects free of ophthalmological disorders.


Eligibility criteria:
inclusion criteria: * age over 18 ; * non-presbyopic subject; * stereoscopic acuity ≤ 60 arc seconds. exclusion criteria: * accommodative insufficiency; * accommodative inertia; * compensation by orthokeratology (i.e. night lenses); * present or past binocular pathology (strabismus or amblyopia); * pregnant or nursing woman; * incomprehension of french (written and spoken).
penetration-enhanced direct dbd non-thermal plasma for hair loss

Conditions: Androgenetic Alopecia

Summary: in-office applied non-thermal atmospheric pressure plasma treatment on ns pretreated scalp


Eligibility criteria:
inclusion criteria: * diagnosis of mild-to moderate androgenetic alopecia * ability to keep in-person follow-up appointments exclusion criteria: * any inflammatory scalp condition * starting or discontinuing any hair loss treatments within 6 months of start date * allergy to any components of the carrier solution
biomarker for friedreich's ataxia (biofrida)

Conditions: FXN Gene; FRDA; Hereditary Diseases

Summary: international, multicenter, observational, longitudinal monitoring study to identify biomarker/s for friedreich's ataxia and to explore the clinical robustness, specificity, and long-term variability of these biomarker/s

an ataxia is neurological disorder of balance and coordination resulting from dysfunctions of the cerebellum. friedreich's ataxia (frda) is most common ataxia in white population, with an estimated prevalence of 2-4 cases per 100,000 individuals. with an average age of onset of 10-15 years, the disease is characterized by dysarthria, deep sensory loss, hypertrophic cardiomyopathy, spinocerebellar ataxia, pyramidal weakness, diabetes mellitus, and skeletal abnormalities. frda is an autosomal recessive disorder caused by pathogenic variant/s in the fxn gene, which encodes the mitochondrial protein frataxin. in 98% of cases these are homozygous guanine-adenine-adenine (gaa) triplet repeat expansions in the ﬁrst intron of the fxn gene. the remaining cases are compound heterozygotes for a gaa repeat expansion plus a fxn point mutation or deletion. gaa repeat expansions suppress transcription of the fxn gene, leading to frataxin deﬁciency. until now there is no fda-approved therapy for frda, but potential agents for treatment are in developing phases. as such, especially antioxidants like idebenone are tested in clinical trials as frta medication, whereas another study identified p38 inhibitors as potential therapeutic agents. various clinical rating scales including the scale for the assessment and rating of ataxia (sara), friedreich's ataxia rating scale (fars), and the international cooperative ataxia rating scale (icars) have been used as trial endpoints in frda, but these measurements have limited sensitivity to disease progression over 12 months. furthermore, there are no validated, objective central or peripheral nervous system biomarkers of disease progression for use in clinical trials as intermediate endpoints. it is the goal of the biofrida study to identify, validate, and monitor frda biomarker/s.

Eligibility criteria:
inclusion criteria: * informed consent is obtained from the participant or parent/ legal guardian * the participant is aged between 2 and 50 years of age * the diagnosis of friedreich's ataxia (frda) is genetically confirmed by centogene exclusion criteria: * informed consent is not obtained from the participant and parent/ legal guardian * the participant is younger than 2 years or older than 50 years of age * the diagnosis of frda is not genetically confirmed by centogene

Keywords: friedreich's ataxia biomarker
study with biocool footcare in subjects with tinea pedis interdigitalis and heel cracks, calluses and/or dry feet

Conditions: Foot Fungus; Tinea; Tinea Pedis; Mycoses; Skin Diseases

Summary: a prospective, open, post-market study that will enroll male and female subjects diagnosed with foot fungus and at least one of the following conditions: heel cracks, calluses and/or dry feet. the investigation will consist of approximately 48 subjects (considering a 10% drop-out/screening failure rate) fulfilling the eligibility criteria for the study. each subject will be treated with the study product, biocool footcare (footbath), for 3 weeks. the study duration is estimated to 5 months including recruiting, treatment and follow-up period.


Eligibility criteria:
inclusion criteria: the subjects have to meet all of the following criteria to be eligible to participate in the clinical investigation: 1. signed informed consent form 2. \> 18 years of age 3. males and females 4. tinea pedis (athlete's foot) confirmed with total symptom score graded between 6-16 (erythema, erosions, macerations, pruritus, fissures, burning/stinging, hyperkeratosis and odour) using a 4-point severity scale (0=absent, 1=mild, 2=moderate and 3=severe). note! maximum total score is 24. - score of 2 (moderate) of higher required in at least 1 of the following; erythema, macerations, pruritus or odur. 5. score of at least 2 (moderate) required in at least one of the following: heel cracks (rhagades), calluses (hyperkeratosis) and dry feet using a 5-point severity scale (0=absent, 1=mild, 2=moderate, 3=advanced and 4=severe). 6. patient with confirmed mycological culture exclusion criteria: subjects meeting any of the following criteria will not be permitted to participate in the clinical investigation: 1. severe tinea pedis interdigitalis (athlete's foot) total score of severity grading \>16 (signs and symptoms) 2. women pregnant or lactation at time of enrolment 3. diagnosed with diabetes type i or ii 4. topical medicinal antifungal therapy within 4 weeks prior to study start 5. treatment with systemic anti fungal therapy including terbinafine, itraconazole or fluconazole within 6 months prior to study start 6. treatment with local amd/or systemic corticosteroids or immunosuppressant's within 6 weeks prior to study start 7. any other open wounds/lesions in the area treated with the investigational device 8. participated in another clinical investigation/trial the last 3 months 9. any other medical condition, judged by the investigator may make follow-up or investigation inappropriate