Kornimate/medical-research-clean huggingface dataset:
a study to evaluate and compare injections of autologous mixed population of dermal cells into the balding scalp of subjects with hair loss (ca-0005995)

Conditions: Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness

Summary: evaluate the ability of injections of ji gami(tm) cn to induce hair growth in male and female subjects with hair loss.


Eligibility criteria:
inclusion criteria: * male and female volunteers 18 to 65 years old, inclusive * hair loss consistent with ≥ grade iii-vertex, iv, va, v, and vi, based on norwood-hamilton scale providing there is bridging of hair in the anterior edge of the vertex circle. * able to provide informed consent after risks and benefits of the study have been explained. * be willing to undergo all study procedures. * ability to communicate effectively with study personnel. * have no clinically significant disease or abnormal laboratory evaluations taken at the screening visit. * agree to abstain from use of any hair growth affecting oral or topical medication including over the counter and herbal medications, minoxidil, finasteride or dutasteride during the course of this study. exclusion criteria: * known sensitivity to dmem/f-12 or any component of the study material. * known hypersensitivity to clindamycin hydrochloride, amphotericin b or streptomycin sulfate. * subjects who have used minoxidil or any oral or topical medication including over the counter and herbal medications for the treatment of hair loss within 6 months of study screening, or finasteride or dutasteride within 12 months of study screening. * a history of drug or alcohol abuse within 1 year of study enrollment. * participation in any other investigational study within 30 days or six half lives of its biologic activity, whichever is longer, before the scalp excision visit(s), and during the time enrolled in this study. * clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator. * clinically significant abnormal laboratory parameters. * a positive result at screening for human immunodeficiency virus (hiv 1 or 2), hepatitis b or c, htlv i/ii. * clinically significant dermatologic condition in donation or study areas. * prior surgery in the donor or study areas. * insufficient hair or scarring in the donor area that might impact cell growth. * any disease or condition (medical or surgical) that, in the opinion of the investigator, might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system function; or any condition that would place the subject at increased risk.

Keywords: androgenetic alopecia male pattern baldness female pattern baldness hair loss baldness
nationwide utilization of danish government electronic letter system for confirming the effectiveness of behavioral nudges in increasing influenza vaccine uptake among adults with chronic disease

Conditions: Influenza; Behavior and Behavior Mechanisms

Summary: in randomized clinical trials and observational studies, influenza vaccination has been shown to be effective in reducing influenza-related illness, hospitalizations, cardiovascular events, and mortality in select populations. however, the real-world effectiveness of influenza vaccination is limited by its uptake. conducted during the 2023/2024 influenza season, the first nudge-flu-chronic trial demonstrated the effectiveness of behavioral nudging letters in increasing influenza vaccination rates among adults aged 18-64 years with chronic diseases in denmark. this present study will once again investigate whether digital behavioral nudges delivered via the official, mandatory danish electronic letter system can increase influenza vaccine uptake among adults aged 18-64 years with chronic diseases including whether the effectiveness of the previously successful strategies can be confirmed during a subsequent influenza season.

the study is a prospective, randomized, open-label implementation trial. the study population will consist of persons aged 18-64 years identified as eligible for free-of-charge influenza vaccination due to a chronic condition. subjects will be identified through danish nationwide health registries using codes from the international classification of diseases, 10th revision (icd-10). individuals will be randomized to 1 of 7 arms (1 usual care arm and 6 intervention arms) with each testing different nudging strategies employing various behavioural economic principles. the interventions will be delivered through the official, mandatory danish electronic letter system. all subject data will be retrieved from the danish nationwide registries with the exception of information on intervention allocation. endpoints will be retrieved at prespecified dates using prespecified search algorithms.

Eligibility criteria:
inclusion criteria: 1. age 18-64 years 2. must be registered in the danish nationwide registries as meeting at least one of the following eligibility criteria for free-of-charge influenza vaccination in the danish public health system: 1. chronic lung disease 2. chronic cardiovascular disease other than hypertension 3. type 1 or type 2 diabetes mellitus 4. congenital or acquired immunodeficiency 5. impaired breathing due to muscular weakness 6. chronic renal or hepatic insufficiency 7. other chronic conditions with an increased risk of severe influenza as determined by the treating physician 3. access to the official, mandatory danish electronic mailbox system exclusion criteria: none

Keywords: influenza vaccination nudging behavioral science randomized trial registry
effect of different bandage interface pressures on breast cancer related lymphedema

Conditions: Lymphedema of Upper Limb; Breast Cancer Lymphedema; Edema Arm

Summary: the goal of this randomised comparison study is to compare different bandage interface pressures in individuals with breast cancer related lymphedema the main questions it aims to answer are: * is high or low bandage pressure effective in reducing edema and soft tissue thickness? * do bandages applied with high or low bandage pressure comprimise sleep, comfort or subjective benefit from treatment? participants will recieve complex decongestive physiotherapy. bandage will apply high or low pressure. effects of high and low bandage interface pressures will compare

the aim of this study was to evaluate the effect of compression bandage applied with different pressures on skin and subcutaneous thickness in individuals with breast cancer-related lymphedema. individuals with stage 2 unilateral lymphedema participated in the study. skin and subcutaneous thicknesses, extremity volumes, sleep quality, treatment benefit, comfort during treatment were evaluated respectively by ultrasound from 6 reference points as dorsum of hand, wrist volar, forearm dorsum, forearm volar, arm dorsum, arm volar, volumetric measurement, pittsburgh sleep quality index, patient benefit index-lymphedema, and visual analog scale. complex decongestive physiotherapy was applied to individuals randomly divided into two groups: low (20-30 mmhg) and high bandage pressure (45-55 mmhg). individuals were evaluated before treatment, at 1st, 10th session, end of treatment, and at 3 months follow-up.

Eligibility criteria:
inclusion criteria: * stage 2 unilateral bcrl involving whole extremity according to isl * to be volunteer. exclusion criteria: * acute deep vein thrombosis * acute soft tissue infection * peripheral artery disease in upper extremity * systemic diseases with peripheral edema (kidney, hearth insufficiency etc.), * allergy to materials used for treatment * mental diseases effect cooperation * sensory loss in the effected limb * open wound in the effected limb.

Keywords: compelex decongestive physiotherapy bandage interface pressure compression therapy
an study of patidegib topical gel, 2%, for the reduction of disease burden of persistently developing basal cell carcinomas in patients with non-gorlin high frequency bcc

Conditions: Recurrent Basal Cell Carcinoma

Summary: this is a multicenter, randomized, double-blind, stratified, vehicle-controlled study of the efficacy and safety of patidegib topical gel, 2%, applied topically twice daily to the face of adult participants with non-gorlin hf-bcc (high-frequency basal cell carcinoma). participants will be randomized (1:1) to receive either patidegib topical gel, 2%, or vehicle for 9 months. randomization will be stratified by gender. the primary endpoint is the number of nseb (surgically eligible basal cell carcinoma) that develop on the face over the 9 month period. the primary end point will be assessed by imaging and tracking of bccs consistently throughout the study in order to identify nsebs.


Eligibility criteria:
inclusion criteria: 1. the subject must have had at least 10 (with at least 3 on the face) clinically typical bccs present within 24 months prior to screening and randomization (baseline/day 1). additionally, the subject must have at least 2 bccs with longest diameter \<5 mm present on the face prior to screening and randomization (baseline/day 1). 2. the subject must be willing to abstain from application of a non-study topical medication (prescription or over the counter) to facial skin for the duration of the trial except as prescribed by the investigator. exclusion criteria: 1. the subject has been previously diagnosed with gorlin syndrome 2. on medical history, family history or clinical examination there is a suspicion that the patient has gorlin syndrome. 3. patients with a family history of medulloblastoma 4. the subject has used topical treatment to the face or systemic therapies that might interfere with the evaluation of the study ip. 5. the subject has uncontrolled systemic disease. 6. the subject has been treated for invasive cancer within the past 5 years excluding non-melanoma skin cancer, stage i cervical cancer, ductal carcinoma in situ of the breast, or chronic lymphocytic leukemia (cll) stage 0.

Keywords: high frequency basal cell carcinoma non-gorlin hf-bcc bazex-dupré-christol syndrome rombo syndrome oley syndrome xeroderma pigmentosum (xp) syndrome bcc seb hedgehog inhibitor basal cell nevus syndrome basal cell carcinoma surgically eligible basal cell carcinoma patidegib hfbcc hhi
tibiopedal access for crossing of infrainguinal artery occlusions

Conditions: Peripheral Arterial Disease; Critical Limb Ischemia

Summary: the objective of this prospective, non-randomized, multicenter, post-market, observational study is to compile clinical data on percutaneous techniques used to obtain tibiopedal access and to cross infrainguinal arterial occlusions.


Eligibility criteria:
inclusion criteria: * patient has a totally occluded infrainguinal artery, due to peripheral arterial atherosclerotic disease, for which a previous attempt to cross the occlusion using an antegrade approach was unsuccessful. for institutions where tibiopedal access is performed as a primary standard-of-care procedure, a prior unsuccessful antegrade approach attempt is not required. exclusion criteria: * patient will not sign the informed consent
effect of high-protein high-fiber diet in patients with autoimmune hepatitis

Conditions: Autoimmune Hepatitis; Cirrhosis

Summary: autoimmune hepatitis is a chronic disease of the liver caused by an alteration of the immune response that attacks the body's own hepatocytes, progressively, leading to cirrhosis and liver failure. there are few studies on dietary management in hepatitis and most of theme have focused on micronutrients specifically vitamin d to prevent osteoporosis, and decreased symptoms of other diseases associated, but few recommendations have been made regarding a complete dietary approach. fiber has been proven to increase the excretion of nitrogen products and consequently reduce its blood levels and an adequate protein intake (1.2g/kg) has shown to decrease endogenous catabolism in cirrhotics patients. the implementation of a high protein high fiber nutrition plan and improves nutritional status of patients with autoimmune cirrhosis.

each participant will receive a high protein (1.2g/kg/day) and high fiber (30g/day) dietary plan. the monitoring of adherence to the diet will be once a month for the duration of the study period. there will be an nutritional assessment by anthropometric techniques: arm circumference, triceps skinfold, weight, height and body mass index as parameters of malnutrition by taking the standard for cirrhotic patients. body composition was measured by bioelectric impedance to obtain fat mass, lean and total fluid content. the presence of minimal hepatic encephalopathy will be assessed by phes and cff and applied three times during the study and the quality of life questionnaire sf-36 cldq and will be held in direct interview at the first visit and at study end. were also measured serum concentrations of ammonium, tnf-alpha, il-1, il-6, il-10, renin, angiotensin and aldosterone.

Eligibility criteria:
inclusion criteria: autoimmune hepatitis (non cirrhotic) * diagnose of autoimmune hepatitis * presence of antinuclear antibody (ana, sma) * biochemical evidence, based on elevation of transaminases * biopsy compatible with autoimmune hepatitis * ambulatory patients autoimmune hepatitis (cirrhotic) * presence of antinuclear antibody (ana, sma) * biochemical evidence, based on elevation of transaminases * biopsy compatible with autoimmune cirrhosis * hepatic cirrhosis by usd * ambulatory patients * diagnose of autoimmune cirrhosis by two or more of the following criteria: * albumin \<3.4g/dl * inr\>1.2 * total bilirubin \>2mg/dl * presence of esophageal varices by endoscopy exclusion criteria: * hospitalized patients * overlapping syndrome with predominant primary biliary cirrhosis * chronic renal failure * hepatocellular carcinoma * neuropsychiatric disorders
radiomics and metabolomics in the follow-up of car t-cells for refractory or relapsed non-hodgkin's lymphoma

Conditions: Refractory or Relapsed Non-Hodgkin's Lymphoma

Summary: this is an interventionnal pilot study to investigate whether 18fdg radiomics or serum metabolomic signatures could be predictive or prognostic factors in the follow-up of patients receiving car t-cell therapy for refractory non-hodgkin's lymphoma or in relapse.

in this study the search for relevant radiomic signature will be carried out for each patient benefiting from an 18fdg pet-ct during the pre-treatment assessment and then in the follow-up at 1 month, 3 months, 6 months, 9 months and 12 months post treatment. the search for circulating metabolites in serum (mass spectrometry) will be carried out during the pre-therapeutic assessment, then in the follow-up at 7 days, 1 month, 3 months, 6 months, 9 months and 12 months post treatment. the main objective of the study is the comparison of signatures from radiomics and early serum metabolomic indices according to progression-free survival at 12 months of patients treated with car t-cells for refractory or relapsed non-hodgkin's lymphoma, in correlation with clinical and biological monitoring, to predict tumor response. the secondary objective is the comparison of the signatures of early serum radiomic and metabolic indices according to the occurrence of serious clinical and/or biological side effects in the 12 months following treatment with car t cells.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years old * patients with histologically proven, refractory or relapsed, non-hodgkin's lymphoma as indicated for car t-cell therapy * ecog score 0 to 2 * affiliated patient or beneficiary of a social security scheme * patient having signed prior informed consent. exclusion criteria: * be under 18 years old, * contraindication to performing 18fdg pet-ct examinations: severe claustrophobia, unbalanced diabetes during pet-ct examinations (young capillary blood sugar ≥ 11 mmol), * any participation in other biomedical studies relating to drugs, medical devices or imaging techniques is prohibited, with the exception of so-called non-health product biomedical studies. * hypersensitivity to the active substance or to any of the excipients in the composition of car t-cells preparations * pregnant or breastfeeding women
comparison of the non-rebreather mask with the double-trunk mask

Conditions: Hypoxemia

Summary: this study will compare the impact of the double-trunk mask (dtm) with the non-rebreather mask (nrm) on the blood gases of patients with severe hypoxemia.

the double-trunk mask (dtm) is a device designed to increase the fraction of inspired oxygen in patients who receive oxygen therapy. the mask is composed of a regular aerosol mask with corrugated tubing (15 cm length) inserted into two lateral holes. each included patient will wear the standard non-rebreather mask (nrm) which is the standard delivery oxygen system for patients with acute severe hypoxemia. then the patients will wear the dtm for 30 minutes. finally the dtm will be replaced by the nrm for the next 30 minutes. the impact of both oxygen delivery system will be assessed by measuring the change of blood gases with each system.

Eligibility criteria:
inclusion criteria: • acute hypoxemia not corrected with nasal cannula exclusion criteria: * chronic obstructive pulmonary disease or other chronic respiratory disease with hypercapnia * confusion * contra-indications to arterial blood gas sampling (peripheral arteriopathy, bleeding disorder)
evaluation of the safety and efficacy of fbpm10 system in the treatment of post-surgical wounds

Conditions: Post-surgical Wounds

Summary: this is a prospective randomized controlled case series in patients having a surgery for bilateral breast reduction. objectives of the case series are to evaluate the safety and efficacy of the fbpm10 system when compared with standard of care (massages with vitamin e cream) in the treatment of post-surgical wounds.


Eligibility criteria:
inclusion criteria: 1. signed and dated written informed consent form; 2. female 18 years of age and older; 3. good general health, stable weight, free of systemic diseases such as diabetes, arthritis, hiv infection or genetic disorder that could influence the outcome of the treatment; 4. fitzpatrick skin type i to iii; 5. patients with bilateral breast reduction, expected to have newly formed post-surgery breast incisions of comparable length and of comparable appearance, located on comparable skin area; 6. patients able to understand, willing and able to comply with all study requirements and post-operative instructions. exclusion criteria: 1. inability to understand the study and its requirements or to give informed consent; 2. systemic antibiotic therapy or anti-inflammatory drugs or any other medication(s) that might interfere with healing within the last three months prior to treatment initiation; 3. current use of anticoagulants such as (but not limited to) warfarin, clopidogrel, enoxaparin or high doses of aspirin (\> 162 mg daily); 4. female pregnant patient (by medical history or as ascertained by a pregnancy test); 5. patient with current alcohol use or actively consuming drugs (addiction) as it may interfere with patient's ability to comply with study procedures; 6. patient with known photosensitivity, taking drug(s) to treat photosensitivity, with concurrent disease (such as porphyria) or drug(s) (such as methotrexate or chloroquine) known to induce severe photosensitivity of the skin; 7. patients who are immunocompromised or taking immunosuppressive therapy; 8. any concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study investigational device; 9. patient has ongoing malignant disease of any type, active systemic, local skin infection or disease, autoimmune disease or any significant chronic disease which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or would result in non-compliance with the study protocol; 10. patients having had surgery in the area to be incised within one year of study screening; 11. patients with tattoos in the areas of incisions; 12. patients with history or familial history of keloids or hypertrophic scars; 13. patients with incisions that are actively bleeding; 14. patients with known skin hypersensitivity; 15. patients with known allergic reactions to silicone. 16. patients that cannot start the treatment within 14 days of the surgery.
a retrospective study to validate bioep as an assessment aid for seizure susceptibility

Conditions: Epilepsy

Summary: the goal of this retrospective study is to validate bioep during routine adult eeg recording in an outpatient setting, using patients with a known epilepsy diagnosis. the main objectives of the study are: * to validate bioep during routine adult eeg recording in an outpatient setting, using patients with a known diagnosis * to examine whether the use of bioep could support a more efficient patient pathway to diagnosis (thus adding economic value), by reducing time to final diagnosis and/or the number of clinical appointments needed.


Eligibility criteria:
inclusion criteria: * adults (age 22 and above) who had a routine eeg in an outpatient setting, following a suspected seizure. * a diagnosis of epilepsy or alternate condition has been reached. a period of at least 3 years has passed since ultimate diagnosis, which itself has remained stable. * eegs performed to abret \& ifcn standards using a minimum of 19 electrodes and additional technical requirements. exclusion criteria: * subject was not suspected of having had a seizure or epilepsy. * subject has a dual diagnosis of epilepsy and non-epileptic seizures. * subject's final diagnosis unknown, unstable, or less than three years passed since an unchanged diagnosis was made. * incomplete or unreliable metadata, such as the age, sex, and treatment status at the time of the eeg recording. * sleep deprived eeg recordings in the outpatient setting. * encephalopathic subjects. * poor quality eegs (multiple artefacts) that do not fulfil technical criteria for analysis. * known structural abnormalities or skull breaches, including historical cases, or with people with metal or plastic implants in their brain or skull.
study of mra for polyarticular juvenile idiopathic arthritis (pjia)

Conditions: Systemic Juvenile Idiopathic Arthritis

Summary: this is an open-label, phase iii study to evaluate the efficacy, safety and pk of mra in patients with pjia.


Eligibility criteria:
inclusion criteria * patients who are diagnosed with rheumatoid factor (rf) positive or negative polyarthritic or oligoarthritic jia according to the ilar standards (1997) * patients aged at least 2 years old and less than 20. * patients aged less than 16 years old at time of onset exclusion criteria * patients with class iv steinbrocker functional disorder at evaluation within 2 weeks before initiation of treatment with the investigational product * patients who have been treated for the underlying disease with a biological agent, such as infliximab or etanercept, within 12 weeks before initiation of treatment with the investigational product