Kornimate/medical-research-clean huggingface dataset:
immunogenicity and safety of verorab™ in indian population

Conditions: Rabies

Summary: * to demonstrate that rabies vaccine administered according to the thai red cross, (trc)-id regimen (2-2-2-0-1-1) is not inferior to rabies vaccine administered according to the essen im regimen in terms of geometric mean titers (gmts) at d28, in subjects with a who category iii rabies exposure,or, * to demonstrate that rabies vaccine administered according to the zagreb-im regimen (2-1-1) is not inferior to rabies vaccine administered according to the essen im regimen in terms of gmts at d28, in subjects with a who category iii rabies exposure. secondary objectives: 1. to describe the immunogenicity profile of each regimen 2. to assess the safety of the vaccine in each group.


Eligibility criteria:
inclusion criteria: * subject with who category iii rabies exposure * subject aged at least 2 years old (day of second birthday) exclusion criteria: * subject unable to comply with the follow-up schedule of the protocol * delayed post-exposure treatment (\>72 hours between incident and treatment * subject bitten by an observable animal at the inclusion visit * subject with immune-compromised or underlying diseases which may lead to inferior immune response * subject with known pregnancy at the time of inclusion * subject enrolled or scheduled to be enrolled in another clinical study. * subject with acute febrile illness/ axillary temperature \> 37.5 degree celsius * subject in whom blood sampling will be difficult. * subject receiving chloroquine or other anti-malarial treatment * subject receiving immunosuppressive therapy, other immune-modifying drug or cytotoxic drugs * subject with known chronic illnesses (ie. heart, lung, kidney, liver) including immunosuppressive diseases (cancer, hiv, etc.) * previous rabies immunization * subject having received any vaccine within the previous 30 days, except tetanus toxoid and tetanus immunoglobulin * subject with clinical signs of rabies * subject with known allergy to vaccine components (e.g. neomycin) * subject who received blood and/or plasma transfusion within the past 3 months

Keywords: rabies; rabies post-exposure; category iii
neuromuscular control of the ankle with external support

Conditions: Chronic Ankle Instability

Summary: untreated ankle sprains often remain symptomatic and may end in chronic instability. the aim of our study is to quantify the stabilizing effect of different devices. through the combined use of the 3d motion analysis and the surface electromyography, the influence of the devices with respect to a mechanical effect and to an influence on the neuromuscular control are examined. the tests will simulate situations with a higher risk of injury. in the experimental set-up, an element of surprise will be integrated in order to analyze any muscular compensation mechanisms.


Eligibility criteria:
inclusion criteria: * chronic ankle instability * "giving way" * repeated ankle sprains exclusion criteria: * other injuries of the lower extremities * surgery on the lower extremities
study to evaluate the efficacy, safety, and tolerability of topical vda-1102 ointment in subjects with actinic keratosis

Conditions: Actinic Keratosis

Summary: this is a phase 2 clinical study in patients with actinic keratosis involving daily application of 1 of 2 strengths of vda-1102 topical ointment for approximately 12 weeks (84 days). this study has no placebo and the subjects enrolled in the study will know exactly what they are receiving. the objectives of the study are to evaluate the safety and benefit of these two strengths.

this phase 2 clinical trial is a 3-part, open-label, multi-center study involving a non-occluded, daily topical dermal application of 1 of 2 strengths of vda-1102 ointment for approximately 12 weeks (84 days) to an initial 2 cohorts of subjects. the first 40 eligible subjects will be enrolled into cohort 1 (part a). cohort 1 subjects will be assigned to receive approximately 200 mg of 10% vda-1102 twice-daily (bid). once approximately 40 subjects have been enrolled in cohort 1, cohort 1 will be closed to enrollment and cohort 2 (part b) will be opened for enrollment. cohort 2 subjects will be assigned to receive approximately 200 mg of 20% vda-1102 once-daily (qd). once approximately 40 subjects have been enrolled in cohort 2, an additional 70 subjects will be randomly assigned to cohort 1 or cohort 2 (part c) in a 1:1 ratio. to qualify for the study, subjects aged 18 (inclusive) or older must have signed informed consent and met the study enrollment criteria that include having 4-8 actinic keratosis (ak) lesions within an approximate 25 cm2 area on the cheek, forehead, or hairless scalp (the "treatment field").

Eligibility criteria:
inclusion criteria: * 4-8 grade 1 or grade 2 ak lesions in treatment field on face or scalp exclusion criteria: * subject has no clinically significant findings at baseline * subject is unable to demonstrate adequate precision applying the study drug to the treatment field at baseline * subject has in the opinion of the investigator (a) an unstable medical, psychiatric, social problem * subject has at any time been given a diagnosis or treatment associated with immunosuppression * subject has received vda-1102 in the past

Keywords: actinic keratosis efficacy safety vda-1102
beneficial effects of dietary and lifestyle change in overweight and obese subjects

Conditions: Overweight and Obesity; Cardiovascular Diseases; Metabolic Syndrome; Non-Alcoholic Fatty Liver Disease

Summary: obesity and overweight are noncommunicable diseases with increasing incidence in children, adolescents and adults. in 2016, more than 1.9 billion adults aged 18 and over were overweight and over 650 million were obese (who). in the eu-27 (eurostat data), 45.7% of women and 60.2% of men were overweight, while 16.3% and 16.8%, respectively, were obese. the growing incidence of overweight and obesity generate worldwide increasing incidence of related conditions as cardiovascular diseases, diabetes, metabolic disorders, and cancer, with relevant socio-economical (increase in health costs, increase in disabilities) and environmental consequences (unsustainability of food models, increase in ecological footprint, worsening of climate changes). a transformation of food systems and individual behaviours are necessary to improve the quality of life and the sustainability of lifestyle, which should be oriented at preventing o treating overweight and obesity.

the study is aimed to measure the beneficial effects of specific dietary models (i.e., mediterranean diet) and healthy lifestyle (i.e., controlled physical activity) in reducing body/organ fat accumulation and in the improvement of metabolic health. a comprehensive and combined analysis of these effects (mainly following personalized strategies and close follow-up) on pathogenic mechanisms affecting cardiovascular and metabolic risk, pro-inflammatory status and intestinal permeability in the medium-long term is still lacking. during the study, overweight/obese subjects (i.e. body mass index equal or higher to 25kg/m2) will be assessed at basal and monitored during a 24 months follow-up

Eligibility criteria:
inclusion criteria: * overweight or obese patients * patients who able to sign informed consent exclusion criteria: * failure to sign informed consent; * inclusion in other research protocols * normal weight patients

Keywords: overweight and obesity cardiovascular diseases mediterranean diet lifestyle physical activity metabolic disorders
incidence and risk factors of early onset colorectal cancer

Conditions: Colorectal Neoplasms

Summary: early onset colorectal cancer (cancer in person younger than 50 years) has increasing incidence last years. the aim of our study was to assess the real-life incidence of early onset colorectal cancer, advanced neoplasias (colorectal cancer and/or advanced adenoma) and all neoplastic lesions in total in a single non-university endoscopic center.

the investigators retrospectively assessed the incidence of all neoplastic lesions, advanced neoplasias and colorectal cancer in population under 50 years of age compared to population 50 years and older. the investigators collected the data from all colonoscopic examinations performed in non-university hospital frydek-mistek from january 2012 to the end of june 2021.

Eligibility criteria:
inclusion criteria: all patient who underwent colonoscopic examination clear indication for colonoscopy exclusion criteria: not able to underwent colonoscopy
nailfold capillaroscopic pattern changes and its correlation with interstitial lung disease (ild) in systemic sclerosis (ssc) patients.

Conditions: Systemic Sclerosis (SSc)

Summary: detection of different pattern of nail fold capillary changes in ssc patients. correlation of nail fold capillary changes in ssc patients with ild.

ssc is a connective tissue disease characterized by early microvascular damage and dysfunction and immune system activation, as well as progressive fibrosis in the skin and internal organs. nailfold videocapillaroscopy (nvc) is the validated technique to assess ssc microvascular damage and is useful for the early diagnosis and follow-up of ssc micro- angiopathy. several studies have demonstrated correlations between microvascular damage extent and the severity of internal organ involvement, showing that nvc abnormalities correlate with disease activity and severity and may be also predictive for disease worsening. furthermore, successful treatments have been shown to reduce nvc abnormalities in ssc cases, and these findings support the importance of nvc in monitoring ssc patients and also suggest its possible role as an outcome measure for microangiopathy in clinical trials. three different nvc patterns of microvascular damage have been described (\&#34;early\&#34; , \&#34;active\&#34; , \&#34;late\&#34; ).

Eligibility criteria:
inclusion criteria: * adult ssc patients exclusion criteria: - 1-ssc patients aged less than 18 years old. 2-individuals with other autoimmune diseases (rheumatoid arthritis, dermatomyositis, connective tissue disease). 3-congestive heart failure and presence of clubbing. 4-history of smoking. 5-patients unable to co-operate for nail fold capillaroscopic examination.
bi-ventricular epicardial activation in left bundle area pacing: a comparison study

Conditions: Bradyarrhythmia; Pacemaker Syndrome; Biventricular Cardiac Pacemaker Malfunction

Summary: study of the ventricular activation patterns during left bundle area pacing and compare it with baseline activation during normal sinus rhythm in patients with and without baseline bundle branch conduction disorder.

right ventricular (rv) pacing has long been the gold standard treatment for symptomatic brady arrhythmias. right ventricular apical pacing has shown to cause electrical and mechanical desynchrony resulting in left ventricular (lv) dysfunction, and, in some cases, clinical heart failure together with other mechanical and arrhythmic complications. hence, it was necessary to find a more physiologic method of pacing that ensures synchrony. his bundle pacing was first described in 2000, and is more recently adapted as a pacing method with less deleterious effects on the rv. however, lead dislodgement, high pacing thresholds, battery depletion, and difficulty identifying the exact location of his bundle were the most significant concerns related to this method. subsequently, left bundle branch area pacing (lbb-ap), first described in 2017 by huang et al, has emerged as safe alternative with excellent lead stability and capture threshold, and more ability to correct distal conduction disease as compared to his bundle pacing. recent studies report promising mid-term outcome concerning left ventricular desynchrony. to the best of our knowledge, bi-ventricular activation was never studied in patients with lbb-ap. multiple tools have been used to assess biventricular (biv) synchrony specially with chronic resynchronization therapy (crt) including echocardiography and 12 lead ecg. eschalier et al. found that epicardial noninvasive ecg mapping, was better at predicting clinical crt response than qrs duration or the presence of lbbb. activation patterns and timings with rv apical pacing, native lbbb, and biv pacing have been well studied using this tool. with lbbp, however, these activation parameters have not yet been described. this study aims to evaluate bi-ventricular activation in patients equipped with lbb-ap using non-invasive 3d mapping system in patients with or without baseline ventricular conduction disorder.

Eligibility criteria:
inclusion criteria: * 30 patients with a functional lbb-ap pacemaker exclusion criteria: * age \< 18 years * previous cardiac surgery * cardiomyopathy with documented ventricular scar * patients with prior pacemaker

Keywords: left bundle area pacing pacemaker wide qrs
cross-condition validation of the steroid pro

Conditions: Inflammatory Disease; Immune System Disorder; Gastrointestinal Diseases; Dermatologic Disease; Respiratory Disease

Summary: testing a questionnaire about treatment with steroids for skin, lung or gastric conditions

glucocorticoid drugs, also known as 'steroids', are used to treat a range of diseases. it is well-known that steroids can cause many unwanted side-effects. the investigators are interested in measuring the impact of steroids on quality of life, from the patients' perspective. in a previous part of this study, the investigators interviewed participants treated with steroids for a range of rheumatic conditions. the participants were asked how taking steroids affects their everyday lives. a patient questionnaire (the 'steroid pro') was then created focused on the topics identified as being most important to participants. now the investigators would like to test this questionnaire with new participants, aged 18 or over, who are taking steroids for other conditions. this could include participants who have inflammation in the lungs, skin, or bowels. the investigators will also ask for feedback from the medical teams who care for those who have these conditions. the study involves a single interview with a researcher, either online or by telephone. participants who want to take part will be given information about the study and asked to give written consent. participants will be asked to talk about the wording of the questionnaire and how relevant and feasible it is to them. this part of the study is funded by sanofi research and development. the work is being carried out by independent researchers at the university of the west of england (uwe, bristol). participants will be recruited from hospitals in the uk and usa. the investigators hope that the steroid pro questionnaire will be used in future research trials about steroid treatment and alternatives to steroids. the steroid pro questionnaire could also be used in clinics to improve communication between clinicians and patients.

Eligibility criteria:
inclusion criteria: * aged ≥ 18 years old * diagnosed with an autoimmune or inflammatory respiratory, gastroenterology or dermatology condition * treatment with glucocorticoids with intravenous or oral glucocorticoids for an autoimmune or inflammatory condition within the previous year (or longer duration). * ability to give consent. exclusion criteria: * aged \<18 years old * no autoimmune or inflammatory respiratory, gastroenterology or dermatology diagnosis * not treated with glucocorticoids with intravenous or oral glucocorticoids for an autoimmune or inflammatory condition within the previous year (or longer duration) * unable to give consent

Keywords: glucocorticoids steroids health-related quality of life rheumatology respiratory gastroenterology dermatology pulmonology patient patient reported outcomes
risk factors for diabetes after stem cell transplantation

Conditions: Diabetes Mellitus

Summary: this study is proposed to investigate the incidence of post transplant diabetes mellitus (ptdm) as well as associated risk factors for the development of ptdm in patients undergoing allogenic stem cell transplantation.

allogenic stem cell transplantation from related or unrelated donors has been used successfully to cure patients with a variety of hematological malignancies. graft-versus-host disease (gvhd) is an alloreactive immune phenomenon, where the activated donor t cells recognizes the recipient as being foreign and effects a cytotoxic response. gvhd occurring in the first 100 days after transplantation is termed acute gvhd and is characterized by hepatitis, dermatitis, and enteritis. high dose corticosteroids remain one of the cornerstone therapies to treat acute gvhd. however, an association between corticosteroid therapy and the development of diabetes mellitus after solid organ transplantation has become widely recognized. similarly, post transplant diabetes mellitus (ptdm) has been increasingly noted in the allogenic stem cell transplant population, however, to date, no systematic study has been completed to identify the incidence of ptdm and associated risk factors. we propose to investigate the incidence of ptdm as well as associated risk factors for the development of ptdm in patients undergoing allogenic stem cell transplantation.

Eligibility criteria:
inclusion criteria: * 18 - 65 years or age * fulfills institutional criteria for and is scheduled to undergo an allogenic stem cell transplantation at vumc exclusion criteria: * younger than 18 years or older than 65 years * pre-existing diabetes mellitus * positive pregnancy test * unable to complete the conditioning regimen prior to stem cell transplantation * unable to give informed consent

Keywords: allogenic stem cell transplantation diabetes mellitus
refined fecal microbiota transplantation (fmt) for ulcerative colitis (uc)

Conditions: Ulcerative Colitis; FMT; Fecal Microbiota Transplant

Summary: the researchers intend to prospectively study the safety, clinical efficacy and microbial outcomes in patients with recently diagnosed uc with fmt capsule therapy derived from pre-defined donors. donors will be specifically screened for fusobacterium and sutterella species as well as for global diversity. it is unknown if treatment with antibiotics before fmt improves the engraftment and/or efficacy of fmt in uc, therefore the researchers plan to randomize subjects to receive pre-treatment with antibiotics or not before fmt therapy. the research team enroll patients from the susan and leonard feinstein ibd center and our established early diagnosis clinic at mount sinai hospital (msh).

this is an open-label two arm pilot study to measure the safety, microbiological and clinical impacts of fmt in patients with ulcerative colitis. the researchers will prospectively enroll 16 uc patients (up to 20 subjects accounting for subjects dropping out) with moderate-severe disease from one tertiary care referral center. the overall objective of the study is to collect robust clinical data and create a tissue repository including blood, stool and biopsies to understand the safety, efficacy and microbial changes fmt has on uc patients. the central hypothesis is that pre-defined oral capsule administered fmt is safe and effective for the treatment of uc. objectives: to determine the tolerability, feasibility, and safety of using fecal microbiota transplantation orally as an induction agent for patients with ulcerative colitis. to determine whether fecal microbiota transplantation (fmt) delivered via oral capsules can induce clinical remission in patients with mild to moderate ulcerative colitis. assess whether pretreatment with antibiotics improves engraftment and efficacy of fmt in uc. to characterize the impact of orally administered fmt on the microbiota of patients with ulcerative colitis, particularly those changes associated with response or lack of response. study outcomes: clinical remission at week 8, defined as: steroid-free clinical remission (total mayo less 2) and endoscopic remission (mayo endoscopic subscore 0 or 1)

Eligibility criteria:
* adults aged 18 to 75 with uc, with initial diagnosis of uc \>3 months prior to time of study enrollment visit * partial mayo score of 4-10 with endoscopic subscore ≥2 on flexible sigmoidoscopy * permissible uc medications include oral or rectal administered mesalamines * corticosteroids must be discontinued at least 4 weeks before enrollment * documented negative c. difficile and gi pcr for enteric pathogens (biofire) testing before commencement of fecal microbiota transplantation * previous documentation of ulcerative colitis based on colonoscopy/flexible sigmoidoscopy with compatible histology

Keywords: fmt fecal microbiota transplantation fecal microbiota transplant fecal matter transplant ulcerative colitis uc
observational trial of a therapeutic platelet transfusion regimen

Conditions: Acute Myeloid Leukemia; Thrombocytopenia

Summary: application of a therapeutic platelet transfusion regimen in patients with acute myeloid leukemia in complete remission (consolidation therapy)

for the participants a therapeutic regimen for platelet transfusions will be applied: for clinically stable patients platelet transfusion will be given in case of bleeding who ii° or higher, for clinically instable patients platelet transfusion will be given at the decretion of the attending physician. patients with sepsis, septic shock or infections with infiltration of organs (e.g. invasive aspergillosis), plasmatic coagulation disorders or sudden or increasing headache with or without neurologic symptoms should receive prophylactic platelet transfusion, if their platelet count is less then 10/nl. otherwise no prophylactic platelet transfusion will be given irrespective of the actual platelet count. as primary study endpoint the incidence of bleeding episodes who grade iii an iv will be documented. the bleeding incidence will then be compared to a historic cohort.

Eligibility criteria:
inclusion criteria: * acute myeloid leukemia in complete remission exclusion criteria: * plasmatic coagulopathy * history of severe bleeding complications in chemotherapy induced thrombocytopenia * no increment in platelets after platelet transfusion