Kornimate/medical-research-clean huggingface dataset:
residual replication of hiv-1 in the gut associated lymphoid tissue (galt) of patients on highly active antiretroviral therapy (haart): the anrs ep 44 study

Conditions: HIV Infection

Summary: hiv-1 cannot be eradicated from infected individuals by current antiretroviral regimens. cellular reservoirs and tissue sanctuary sites allow latent hiv-1 persistence and ongoing low-level virus replication. this project aims to characterize the residual replication of hiv-1 in subjects on antiretroviral therapy, particularly in the gut-associated lymphoid tissue.

highly active antiretroviral therapy (haart) successfully controls hiv-1 replication in most individuals, resulting in substantial immune restoration and decreased morbidity and mortality. however hiv-1 cannot be eradicated from infected individuals by current regimens. cellular reservoirs and tissue sanctuary sites allow latent hiv-1 persistence and ongoing low-level virus replication, despite maximum virus suppression on haart. this project aims to characterize the residual replication of hiv-1 in subjects on haart, particularly in the gut-associated lymphoid tissue (galt). a group of 20 hiv-1-infected patients on effective haart will undergo gi endoscopy and galt biopsies will be taken. a sample of venous blood will also be collected. these samples will be use to characterize the residual viral populations on effective haart in three compartments, plasma, monocytes, and galt. hiv-1 coreceptor usage and its evolution on haart will be characterized in virus reservoirs. this project could provide further insights into the residual replication of hiv-1 in subjects receiving haart.

Eligibility criteria:
inclusion criteria: * hiv-1 infection (elisa and western-blot tests) * continuous antiretroviral therapy \>= 12 months * plasma hiv-1 rna =\ = 6 months * indication of gastro-intestinal endoscopy * age \>= 18-year old * physical examination * informed consent exclusion criteria: * plasma hiv-1 rna \> 40 copies/ml in the last 6 months * involvement in a hiv vaccine study * treatment with interferon-alpha or peg- interferon-alpha in the last 6 months * treatment with interleukin-2 in the last 6 months * decompensated cirrhosis * abnormal hemostasis tests * inflammatory bowel disease ; coeliac disease * lymphoma * blood transfusion in the last 6 months * absence of social security (health insurance) * pregnant or breastfeeding woman * incapable adult

Keywords: hiv infection haart viral dna test positive-10063306 blood hiv rna 10049826 treatment experienced
effectiveness trial of temperament based therapy with support (tbt-s)

Conditions: Anorexia Nervosa

Summary: the main aim of this project is to determine the short and long-term effectiveness of an out-patient treatment for patients with anorexia nervosa. specifically, we will measure whether tbt-s in addition to treatment as usual (tau) will be more effective than tau alone in reducing eating disorder psychopathology. assessments will be conducted at four timepoints; pre and post tbt-s, and at 3 and 12 months follow-up. primary outcome measure is eating disorder psychopathology, with the hypothesis that patients receiving tbt-s in addition to tau will show significantly greater reduction in eating disorder psychopathology from tbt-s treatment admission to 3 month follow-up, compared to controls.

participants in the intervention arm will receive five days of tbt-s in addition to treatment as usual. tbt-s is administered to three to six adult anorexia nervosa patients with up to four supports per patient. the treatment structure consists of five consecutive days of treatment, up to 7,5 hours each day. staff requirements for tbt-s are three clinicians, one dietician and one medical staff. adults referred to a local psychiatric centre (dps) for out-patient anorexia nervosa treatment, and their supports, will be eligible to participate in the study.

Eligibility criteria:
inclusion criteria: * age ≥18, all genders * a diagnostic and statistical manual of mental disorders (dsm-5) diagnosed anorexia nervosa disorder (f50.0, f50.01, f50.02, also including f50.9 - atypical anorexia nervosa) * willingness to have support(s) participate in treatment * medically stable exclusion criteria: * developmental, intellectual or psychotic disorder * diagnosis of alcohol or drug abuse or dependence in the 3 months prior to the study * receiving in-patient treatment at time of study entry * presence of other psychopathology that might interfere with ability to participate in the study
development of prognostic models for response and toxicity to car-t cell therapy in patients with relapsed/refractory non hodgkin's lymphoma.

Conditions: Non-Hodgkin Lymphoma

Summary: observational, single-center, tissue-based cohort study involving both retrospective and prospective enrollment of patients undergoing car-t cell therapy and up to 1 year of prospective follow-up necessary to detect the outcomes required by the study

this is a pharmacological observational study, with collection of biological material, single-centre, no-profit, involving both retrospective and prospective enrolment of patients undergoing car-t cell therapy and up to 1 year of prospective follow-up necessary to detect the outcomes required by the study.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patients with relapsed/refractory non-hodgkin lymphoma, candidates to receive car-t cell therapy according to clinical indication * acquisition of informed consent for participation in the study * acquisition of consent to the processing of personal data. exclusion criteria: none

Keywords: car-t therapy
financial incentives to increase colorectal cancer screening in priority populations

Conditions: Colorectal Cancer

Summary: the investigators propose to build on the success of the systems of support to increase colorectal cancer trial (sos, r01ca121125, green) and focus on disparity groups who are less likely to be current for colorectal cancer (crc) screening. we will test whether financial incentives increases screening uptake and decreases screening disparities. the investigators hypothesize that crc screening rates will be higher in patients offered mailed fecal kits and financial incentives than those offered mailed fecal kits alone.

study staff will send invitation letters and a questionnaire to 5,000 patients aged 50-75 not current for crc screening, two-thirds who are identified in the electronic data as being from a non-white race, ethnicity, or who have medicaid coverage. those returning the survey and remaining eligible (estimated n = 1150) will be randomized to either (1) mailed fecal kit only, or mailed fecal kit plus one of 2 types of financial incentives for completing testing: (2) a guaranteed monetary incentive or (3) a probabilistic lottery incentive.

Eligibility criteria:
inclusion criteria: * no evidence in electronic data of fit screening in past year or a colonoscopy in the prior 9 years. * continuously enrolled in group health cooperative (ghc) for at least one year. * patients who have medicaid coverage or are non-white race or hispanic any race. exclusion criteria: * known high risk for crc * history of crc * history of inflammatory bowel disease * current anticoagulation therapy * organ failure * serious illness * debilitating disease * dementia * nursing home resident

Keywords: behavioral: automated mailing
holter of movement in patients with amyotrophic lateral sclerosis.

Conditions: Amyotrophic Lateral Sclerosis

Summary: actials is a multicentric academic study. patients with amyotrophic lateral sclerosis (als) may be included on a voluntary basis. the investigators plan to include a group of approximately 30 patients with als. the investigators have planned to assess patient every three months for a year. after each visit, participants will wear actimyo for one month daily.

on each visit, participants will undergo a clinical examination with mrc sum score and ashworth scores. participants will perform few tests (6-minutes walk test (6mwt), dynamometric measure, electromyography, and will answer to some questionaires (dysphagia handicap scale, revised amyotrophic lateral sclerosis functional rating scale). actimyo is an innovative device intended to be used in a home-based environment. it is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.the two watches can be worn as wristwatch or placed near the ankle.

Eligibility criteria:
inclusion criteria: * clinically defined or probable diagnosis of als according to el escorial criteria revised with awaji's electro-diagnostic algorithm. * over 18 years old. * signed informed consent * if patient on riluzole, the dosage should be stable for 1 month and continued throughout the study period. exclusion criteria: * patients with excessive cognitive disorders, limiting the understanding of task or with apparent communication difficulties hindering data collection. * any other previous or present pathology having an impact on motor function. * recent surgery or trauma (less than 6 months) in the upper or lower limbs. * prior neurological, endocrine, infectious, allergic, or chronic or acute inflammatory pathology in the three weeks preceding inclusion. * patients participating in an interventional clinical trial.

Keywords: actimyo accelerometry daily living
collection of ocular surface impressions cytology of the living eye from patients with dry eyes or limbal stem cell deficiency.

Conditions: Eye Diseases

Summary: in order to develop innovative biomarkers for the diagnosis of two ocular surface pathologies, dry syndrome (ds) and limbic stem cell deficiency (lscd), human cells from the ocular surface will be collected in order to test these biomarkers ex vivo.

to collect them, cytological fingerprints of the ocular surface are made using filter paper applied to the surface using a commercially available ec (european conformity)-marked medical device, called eyeprim.

Eligibility criteria:
inclusion criteria: * patient affiliated or entitled to a social security scheme * age 18 years or older * presenting a dry syndrome, a limbic stem cell deficiency (clinical diagnosis) or another pathology (control). * signature of consent exclusion criteria: * major blepharospasm making examination impossible * pregnant women * breastfeeding women * protected persons

Keywords: biomarkers limbic stem cell deficiency dry syndrome eyeprim
randomized controlled clinical investigation evaluating the effect of adipose tissue processed with the syntrfuge™ system in the healing of diabetic foot ulcers

Conditions: Diabetic Foot Ulcer

Summary: this is a randomized controlled multi center study on diabetic patients with the aim of evaluating the efficacy of the adipose tissue processed with the syntrfuge™ system in diabetic patients with diabetic foot ulcers. in particular, it will be evaluated whether the microsized fat graft will be able to shorten the healing times of these wounds. patients will be randomized to the treatment group with adipose tissue processed with the syntrfuge™ system (injection of autologous microsized adipose tissue) or to the control group represented by the standard of care.


Eligibility criteria:
inclusion criteria: 1. subjects who have diabetic foot ulcer located at the plantar or dorsal aspect of the foot or the heel with a surface area of 1.0cm2 - 25cm2 2. index ulcer has been present for greater than four weeks 3. diabetics included will be those with hba1c ≤ 12% 4. subjects aged 18 - 85, inclusive 5. the target ulcer has been offloaded for at least 14 days exclusion criteria: 1. subjects without decisional capacity 2. subjects unable to give informed, written consent 3. subjects with active infection (redness, swelling, pain, suppuration) 4. subjects with active osteomyelitis to the index ulcer 5. subjects with previous treatment with negative pressure wound therapy, growth factors, radiation, hyperbaric o2, or bioengineered tissue product within 30 days of screening 6. subjects with a previous diagnosis of hiv or hep c 7. subject is pregnant or breast feeding 8. subjects receiving oncological treatments ongoing or previous (past 5 years) and/or neoplastic lesions 9. subjects under corticosteroid therapy, unless taking dose of 5mg/dl or less 10. subjects with any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study

Keywords: microsized fat tissue adipose tissue dfu wound management
study to evaluate the efficacy and safety of hepastem in patients with acute on chronic liver failure (aclf)

Conditions: Acute on Chronic Liver Failure

Summary: this is an interventional, double blind, randomized (2:1), and placebo-controlled study of 2 infusions of a 1 dose regimen of hepastem in patients recently diagnosed (≤1 week) with aclf grade 1 or 2 on top of standard of care (soc), and for whom the diagnosis is not resolved on the day of infusion.


Eligibility criteria:
inclusion criteria: 1. are adults aged between 18 and 75 years old. 2. have an initial diagnosis of aclf at the investigational site. 3. have aclf grade 1 or 2 according to the easl-clif consortium definition. 4. have a total bilirubin ≥ 5 mg/dl. 5. are able to read, understand and give written informed consent. main exclusion criteria: 1. have a meld-na score \> 35. 2. have underlying cirrhosis due to biliary disease. 3. have underlying cirrhosis due to autoimmune hepatitis. 4. have active bleeding at a non-compressible site or at a compressible site that, in the opinion of the investigator, poses an unacceptable risk for the patient's participation in the study. 5. have received treatment for bleeding complications during the current hospitalization and has a persistent high risk for re-bleeding that, in the opinion of the investigator, poses an unacceptable risk for the patient's participation in the study. 6. have a complete portal vein thrombosis. 7. have coagulation disturbances defined as: * fibrinogen \< 80 mg/dl * platelets \< 50 x 10³/mm³ 8. are requiring chronic dialysis therapy. 9. have had a cerebrovascular, myocardial, limb arterial thrombotic event, or history for both thrombotic and hemorrhagic cerebrovascular events within 12 months prior to the screening and not considered stabilized by the investigator. 10. have a previous history of myocardial infarction and/or cardiac failure, with an ejection fraction rate (efr) ≤ 40%.

Keywords: aclf hepastem halpc
to compare the efficacy and safety of bp102 vs. avastin® in combination with paclitaxel/carboplatin in first-line treatment of advanced or relapsed nsclc

Conditions: Non-small Cell Lung Cancer(NSCLC)

Summary: this is a randomized, double-blind, positive parallel control, multicentre phase iii clinical trial, a clinical trial of biosimilar drugs, so the type of comparison is equivalence test.


Eligibility criteria:
inclusion criteria: 1. aged from 18 to 75 (including 18 and 75), male or female; 2. patients with locally advanced and unresectable nsclc that has been histologically or cytologically proven, metastatic, or recurrent nsclc. 3. no previous systematic antitumor therapy for current stage diseases. if previous adjuvant therapy has been received, it is necessary to ensure that the interval between the end of adjuvant therapy and the first administration of this study is more than 6 months, and that all adjuvant treating-related toxic reactions have recovered. 4. patients must be able to document the egfr mutation and alk fusion gene status, and alk must be negative. patients who have not previously been tested for egfr and alk genes should be tested during screening; 5. there must be at least one measurable lesion as a target (according to recist v1.1); 6. ecog: 0\~1; 7. life expectancy ≥24 weeks; 8. major organs' function well. exclusion criteria: 1. patients with non-small cell lung cancer of other pathological tissue types; 2. tumor histology or cytology confirmed positive alk fusion gene; 3. patients with imaging evidence of tumor invasion of large blood vessels; 4. patients with uncontrolled pleural effusion and pericardial effusion that require repeated drainage; 5. patients with abdominal effusion; 6. during the screening period, chest ct showed tumor cavity formation, or ct scan was highly suspected of idiopathic pulmonary fibrosis, mechanized pneumonia, drug-associated pneumonia, idiopathic pneumonia or active pneumonia; 7. patients with hypertension whose blood pressure has not been satisfactorily controlled by antihypertensive drugs, and patients with previous hypertensive crisis or hypertensive encephalopathy; 8. have heart disease or clinical symptoms that are not well controlled; 9. patients with unhealed wounds, active gastric ulcers or fractures; 10. patients diagnosed with esophagotracheal fistula; 11. people with known hereditary bleeding tendency or coagulation disorder; 12. patients with known central nervous system metastases.
hepatitis d virus infection among hepatitis b virus surface antigen positive individuals

Conditions: HDV Infection; HBV Infection

Summary: globally, about 248 million people are chronic hbv surface antigen carriers, and about 5% of them also had hepatitis delta virus (hdv) infection as well. the prevalence of hbsag in egypt is intermediate (2-7%) . hepatitis d virus (hdv) is an incomplete rna virus that needs hepatitis b surface antigen (hbsag) to help its replication. hdv is considered a subviral particle because it depends on hbv for its propagation. combined hdv- hbv infection produces more severe liver affection than hbv alone. hdv infection leads to both of acute and chronic liver illnesses. acute hdv infection can occur at the same time with acute hbv infection (coinfection) or can be superimposed on the top of chronic hbv infection. about 20% to 30% of coinfections of hdv and hbv in humans develop fatal fulminant hepatitis versus 2% of patients with acute hepatitis b mono-infection. worldwide, hepatitis d virus (hdv) infection present in more than 15 million people and it is endemic in the middle east . in upper egypt, data about the prevalence, clinical, laboratory and virological characters of hepatitis d virus-infected patients is rare. this study aims were: 1. to estimate the prevalence of hepatitis d virus infection among hbsag positive individuals. 2. to determine the clinical, laboratory and virological characters of hdv infected patients.


Eligibility criteria:
inclusion criteria: * hbv related liver disorder, aged 18-60 years. * hbsag positive individuals were divided into different clinical categories according to easl 2012 and we revised this classification according to easl 2017. hbeag negative chronic infection; hbeag positive chronic infection), acute hepatitis, fulminant hepatitis, chronic hepatitis (hbeag positive and hbeag negative), liver cirrhosis, and primary hcc. exclusion criteria: * dual infection with other viruses as hcv and/or hiv, auto-immune or alcoholic hepatitis.

Keywords: hdv hbsag prevalence upper egypt
adjuvant immunotherapy with toripalimab following curative-intent ablation for recurrent hepatocarcinoma

Conditions: Hepatocellular Carcinoma

Summary: this phase ii study is to evaluate the efficacy of the adjuvant immunotherapy after curative-intent ablation for recurrent hepatocarcinoma


Eligibility criteria:
inclusion criteria: hcc diagnosed as (i) the presence of risk factors including hepatitis b or c virus and liver cirrhosis, a serum a-fetoprotein (afp) level greater than 200 iu/ml and a radiologically compatible feature with hcc in one or more ct/mri/angiograms, or (ii) the presence of risk factors including hepatitis b or c virus and liver cirrhosis, a serum a-fetoprotein (afp) level less than 200 iu/ml, and a radiologically compatible feature with hcc in two or more ct/mri/angiograms or (iii) histological confirmation. hcc patients who had recurrent or residual tumor after other treatments without evidence of extrahepatic metastasis the largest diameter of tumor should be less than 3cm, and the number of tumor ≤2 no previous treatment to target tumors by other forms of rt. liver function of child-pugh class a or b7 (child-pugh score of ≤7). performance status of 0 to 2 on the eastern cooperative oncology group (ecog) score. wbc count ≥ 2,000/mm3; hemoglobin level ≥ 7.5 g/dl; platelet count ≥ 50,000/mm3; and adequate hepatic function (total bilirubin ≤ 3.0 mg/dl; ast and alt \< 5.0× upper limit of normal; no ascites). no serious comorbidities other than liver cirrhosis. written informed consent. exclusion criteria: hcc diagnosed as (i) the presence of risk factors including hepatitis b or c virus and liver cirrhosis, a serum a-fetoprotein (afp) level greater than 200 iu/ml and a radiologically compatible feature with hcc in one or more ct/mri/angiograms, or (ii) the presence of risk factors including hepatitis b or c virus and liver cirrhosis, a serum a-fetoprotein (afp) level less than 200 iu/ml, and a radiologically compatible feature with hcc in two or more ct/mri/angiograms or (iii) histological confirmation. hcc patients who had recurrent or residual tumor after other treatments without evidence of extrahepatic metastasis the largest diameter of tumor should be less than 3cm, and the number of tumor ≤2 no previous treatment to target tumors by other forms of rt. liver function of child-pugh class a or b7 (child-pugh score of ≤7). performance status of 0 to 2 on the eastern cooperative oncology group (ecog) score. wbc count ≥ 2,000/mm3; hemoglobin level ≥ 7.5 g/dl; platelet count ≥ 50,000/mm3; and adequate hepatic function (total bilirubin ≤ 3.0 mg/dl; ast and alt \< 5.0× upper limit. written informed consent. exlusion criteria: evidence of extrahepatic metastasis. liver function of child-pugh class b8-9 and c (child-pugh score of \>7). previous history of other forms of rt adjacent to target tumors. poor performance status of 3 to 4 on the eastern cooperative oncology group (ecog) score. pregnant or breast feeding status. previous history uncontrolled other malignancies within 2 years.

Keywords: immunotherapy toripalimab
the gastrointestinal microbiome of infants with gerd and ppi therapy: a pilot study

Conditions: Gastroesophageal Reflux

Summary: proton pump inhibitors (ppi) are standard in the therapy of pediatric gerd. in the past it has been hypothesized, that either direct inhibition of bacterial atpase or elevation of the ph may lead to changes in the intestinal microbiome. small series published in adults suggest a predominance of streptococci, a possible reason for increased incidences of pneumonia under ppi therapy. studies in children are yet scarce. this study will include 20 infants. gerd will be verified by 24h-intraluminal impedance monitoring. all patients will have undergone conservative measures prior to initiation of ppi therapy (due to persisting symptoms). children will receive a commercial ppi for 8 weeks (esomeprazole 1mg/kg/day). stool samples will be collected before initiation of ppi, under ppi (4 weeks after initiation) and 8 weeks after discontinuing ppi therapy. the intestinal microbiome will be determined by 16s rdna-based microbial community profiling by high-throughput pyrosequencing. data will be compared by dependent non parametric test (wilcoxon). p-values \<0.05 will be considered statistically significant.


Eligibility criteria:
inclusion criteria: symptomatic gerd (proved by impedance monitoring) despite conservative treatment requiring ppi therapy exclusion criteria: neurological impairments

Keywords: infant ppi proton pump inhibitor microbiome microbiota