Kornimate/medical-research-clean huggingface dataset:
studies of the pathogenesis of hiv infection in human peripheral blood cells and/or body fluids in people living with and without hiv

Conditions: HIV; Immunodeficiencies; Infectious Diseases

Summary: we are studying virologic and/or immunologic parameters of hiv infection and other infectious or non-infectious immune deficiency diseases in order to better understand the pathogenesis of hiv. because of the lack of an adequate animal model it is generally necessary to utilize human peripheral blood cells for studying aspects of either in vivo or in vitro hiv infection. we wish to be able to continue to elucidate many pathogenic aspects of hiv infection in relation to other infectious or non-infectious immune regulation and dysregulation using human peripheral blood mononuclear cells as a model.

we are studying virologic and/or immunologic parameters of hiv infection and other infectious or non-infectious immune deficiency diseases in order to better understand the pathogenesis of hiv. because of the lack of an adequate animal model it is generally necessary to utilize human peripheral blood cells for studying aspects of either in vivo or in vitro hiv infection. we wish to be able to continue to elucidate many pathogenic aspects of hiv infection in relation to other infectious or non-infectious immune regulation and dysregulation using human peripheral blood mononuclear cells as a model.

Eligibility criteria:
* inclusion criteria: * 18 years of age or older. * adequate venous access. * have a blood pressure less than or equal to 180/100: pulse rate 50-100, unless a lower pulse rate is considered normal for the volunteer. * have adequate blood counts (volunteers living with hiv: hemoglobin greater than or equal to 9.0 g/dl, platelets greater than or equal to 50,000; volunteers living without hiv: hemoglobin greater than or equal to 9.0 g/dl, platelets greater than or equal to 50,000 * be willing and able to provide written informed consent on screening, comply with study requirements and procedures, and comply with clinic policies * willingness to allow blood samples to be used for future studies of hiv infection/pathogenesis, and undergo hepatitis screening exclusion criteria: * pregnant and/or breastfeeding females. * active substance abuse or history of prior substance abuse that may interfere with protocol compliance or compromise volunteer safety.

Keywords: lymphocytes venipuncture mononuclear cells natural history
ngs screening protocol to detect mutation of keap1 or nrf2/nfe2l2 genes for the keapsake (cx-839-014) trial

Conditions: Non-Small Cell Lung Cancer; Non-squamous Non-small-cell Lung Cancer; Non-Squamous Non-Small Cell Neoplasm of Lung; KEAP1 Gene Mutation; NRF2 Mutation; NFE2L2 Gene Mutation

Summary: this is a multicenter screening protocol designed to identify patients with nsclc who have tumor mutations in the keap1 or nrf2/nfe2l2 genes in order to determine potential eligibility for a biomarker selected clinical trial (cx-839-014, otherwise known as the keapsake trial). circulating tumor dna (ctdna) present in blood samples collected from eligible patients will be analyzed by next generation sequencing (ngs) for selected biomarkers. a commercial liquid biopsy ngs test will be provided to study participants free of charge.


Eligibility criteria:
inclusion criteria: patients with stage iv non-squamous non-small-cell lung cancer (nsclc) who have not been previously treated with systemic therapy for metastatic disease, and meet all of the following: 1. signed and dated ngs informed consent form (icf) by the patient (or legally acceptable representative (lar), if applicable). 2. biopsy-confirmed or clinically suspected stage iv nsclc not previously treated with systemic therapy for metastatic disease. 3. eastern cooperative oncology group (ecog) performance status of 0 or 1. 4. age ≥ 18 years old on the day of signing informed consent. 5. estimated life expectancy \> 3 months. 6. at least one radiographically measurable lesion per recist v1.1 defined as a lesion that is ≥ 10 mm in longest diameter or lymph node that is ≥ 15 mm in short axis imaged by computed tomography (ct) scan or magnetic resonance imaging (mri). 7. clinically eligible to receive standard-of-care combination therapy with pemetrexed + carboplatin + pembrolizumab (pcp) for stage iv disease. exclusion criteria: any contraindication to pemetrexed, carboplatin, and pembrolizumab treatment.

Keywords: nsclc keap1 nrf2 nfe2l2 lkb1 stk11 next generation sequencing ngs mutation gene pembrolizumab pemetrexed carboplatin placebo randomized chemotherapy immunotherapy targeted therapy telaglenastat glutamine glutaminase glutathione front-line first-line non-squamous keytruda alimta guardant360 ldt liquid biopsy ctdna biomarker
the effect of vitamin d supplementation on the pulmonary functions of adult asthmatic egyptian patients

Conditions: Asthma

Summary: this study evaluates the effect of vitamin d supplementation in the form of alfacalcidol on the the pulmonary function of adult asthmatic egyptian patients

asthmatic patients are recruited and divided into two groups. one receives alfacalcidol beside their normal medications while the other acts as a control group receiving the normal asthma medication. both groups are followed up for four months.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed with asthma 2. non-smokers exclusion criteria: 1. liver impairment 2. kidney impairment 3. patients receiving digoxin 4. known hypersensitivity to 1α-hydroxyvitamin d3, vitamin d or any of its analogues and derivatives 5. hypercalcaemia 6. hyperphosphatemia 7. pregnancy and breast-feeding 8. patients on nutritional supplements with a potential effect on 25(oh)d serum concentrations 9. had a history of stones in the urinary tract or diseases of calcium or bone metabolism
eye detection to identify novel coronavirus infection

Conditions: Covid19

Summary: the eye characteristics of patients with covid-19 and those without the disease were analyzed, and whether they had the disease or not was judged according to the eye characteristics.

to test the accuracy of a non-invasive eye monitoring that can be widely used for screening in judging patients with novel coronavirus infection.

Eligibility criteria:
inclusion criteria: 1. all participants were provided with written informed consent at the time of recruitment； 2. age ≥ 18 and ≤ 75 (informed consent signed by guardian under 18) 3. meet the diagnostic criteria of novel coronavirus (2019-covid-19) infection exclusion criteria: does not meet any of the inclusion criteria
evaluating the efficacy of cpap therapy for the treatment of fatty liver

Conditions: Non-alcoholic Fatty Liver Disease

Summary: we are doing this research study to evaluate whether continuous positive airway pressure (cpap), a treatment for sleep apnea, will also help treat fatty liver disease. sleep apnea is a disease where a person has interruptions in their breathing while they are sleep. this can lead to low oxygen levels in the blood. cpap is a mask that delivers oxygen at high pressure to the lungs to prevent a decrease in blood oxygen levels. cpap is a known treatment for sleep apnea.


Eligibility criteria:
inclusion criteria: * adults 18 years of age or older with a previous liver biopsy showing nash and at least grade 2 steatosis * obstructive sleep apnea diagnosed by sleep study. exclusion criteria: * other causes of chronic liver disease * cirrhosis * less than 33% steatosis identified on magnetic resonance spectroscopy (mrs) * alcohol use \>2 units per day for women or \>3 units per day for men * intolerance to or refusal of cpap therapy * overnight desaturation (more than 10% of the sleep time with oxygen desaturation below 85%) * underlying sever sleepiness (epworth scale more than 15) * uncontrolled hypertension * severe heart failure (ejection fracture less than 30%) * cardiac arrhythmias (atrial fibrillation or history of ventricular tachycardia) * those who are commercial drivers

Keywords: non-alcoholic fatty liver disease obstructive sleep apnea
luspatercept in metastatic agct of the ovary

Conditions: Adult Granulosa Cell Tumor of the Ovary

Summary: this is a single participant study of luspatercept for the treatment of a patient with dult granulosa cell tumor (agct) of the ovary.

this patient has agct driven by a somatic oncogenic foxl2 mutation identified through a molecular profiling study. one of the ways in which this mutation drives tumorigenesis is via increased activity of smad3, which results in decreased expression of follistatin and allows increased signalling of activin, a tgfb ligand that activates the tgfb pathway. anti-tgfb approaches have shown promise in preclinical studies of agcts and several early phase trials are investigating different levels of tgfb pathway inhibition1. as an activin receptor ligand trap, luspatercept has been shown to reduce smad2/3 signaling and improve anemia in disorders characterized by ineffective erythropoiesis, such as b-thalassemia and myelodysplastic syndromes (mdss). this study aims to determine if we can apply this rationale to a patient with recurrent agct with oncogenic foxl2 mutation known to drive tgfb/smad pathway overactivity. luspatercept has not been investigated in agct and therefore the efficacy of this specific agent as a cancer therapeutic is not yet known. other tfgb ligand-trapping agents are in development and early phase clinical trials. one such example is avid200, a tgfb ligand trap and selective inhibitor of tgfb1 and advanced solid tumors. there were 19 patients included in a phase i study of avid200 monotherapy in patients with advanced solid tumors. a best response of stable disease for over 12 weeks seen in two patients (adenoid cystic carcinoma and breast carcinoma). the maximum tolerated dose was not reached; no grade 3 adverse events were seen and only three adverse events were reported overall including diarrhea and lipase elevation.

Eligibility criteria:
inclusion criteria: * n/a exclusion criteria: * n/a this patient's case was recently discussed in the hospital expert molecular tumor board rounds consisting of representatives from specialist genomic profiling and gynecologic medical oncology departments. the discussion surrounded the best next therapeutic option in this rare cancer subtype without clear standard of care guidelines. the recommendation from this discussion was to investigate targets of the tgfβ pathway, such as luspatercept. therefore, specific eligibility criteria aside from individual patient's medical history is not applicable.
a study to assess the safety, pharmacokinetics, and antiviral activity of abi-h3733 in subjects with chronic hepatitis b virus infection

Conditions: Chronic Hepatitis B

Summary: this is a randomized, blinded, placebo-controlled, dose-ranging phase 1b study of the safety, pk, and antiviral activity of abi-h3733 in treatment-naïve or off-treatment chronic hepatitis b virus (chbv) subjects that are hepatitis b e antigen (hbeag) positive or negative. the study will enroll up to 5 sequential cohorts of 10 subjects each, for a total of up to 50 subjects, randomized 8:2 to receive abi-h3733 or placebo.


Eligibility criteria:
inclusion criteria: 1. body mass index (bmi) ≥ 18.0 and \< 35.0 kg/m(2), where bmi = weight (kg)/(height \[m\])(2) with a minimum body weight of 45 kg. 2. chronic hepatitis b infection, defined as hbv infection for ≥6 months documented 3. treatment-naïve or off-antiviral therapy for ≥24 weeks prior to screening 4. lack of bridging fibrosis or cirrhosis exclusion criteria: 1. co-infection with human immunodeficiency virus (hiv), hepatitis c virus (hcv), hepatitis d virus (hdv), acute hepatitis a virus (hav), or acute hepatitis e virus (hev) 2. history of liver transplant or evidence of advanced liver disease, cirrhosis, or hepatic decompensation 3. clinically significant diseases or conditions 4. history of hepatocellular carcinoma 5. current or prior treatment for chbv

Keywords: chbv hbv hepatitis b
transcranial direct current stimulation (tdcs) as treatment method for pain in fibromyalgia

Conditions: Fibromyalgia

Summary: the purpose of this study is to investigate transcranial direct current stimulation as treatment method for pain in fibromyalgia.

fibromyalgia (fim) is a chronic pain condition with high prevalence. studies involving neuroimaging techniques have identified functional differences in cerebral pain processing in patients with fim, as compared to healthy controls. this may support that fim do have a functional cns component. transcranial direct current stimulation (tdcs) is a non-invasive and safe method for inducing changes in cortical excitability. previous studies showed that anodal stimulation of m1 may change pain perception, possibly by modulating functional anomalies in the fim brain. the present study has two main goals: 1. to investigate if tdcs may provide fim patients with symptom relief due to reduction of pain. 2. to investigate tdcs induced functional changes in the brain by using fmri.

Eligibility criteria:
inclusion criteria: * fibromyalgia (acr-90 criteria, m79.7 icd10) * mean vas \> 4 daily 2 weeks prior to study). exclusion criteria: * severe mental disease * cns disease * mental retardation * age \< 18
retrospective study chimaera long nail in adult patient

Conditions: Pertrochanteric Fracture of Femur; Intertrochanteric Fracture of Femur; Subtrochanteric Fracture of Femur

Summary: the chimera study intends to evaluate the clinical benefits of the study medical device in the standard clinical practice.

the chimera study intends to evaluate the clinical benefits of the study medical/investigational device in the standard clinical practice. the study will be conducted in two sites located in italy; both considered reference sites for the treatment of adult patients with pertrochanteric, intertrochanteric and subtrochanteric fractures of the femur, where the usage of orthofix® chimaera hip fracture systemtm (from now on chimaera) was part of the normal clinical practice. the chimaera, is an internal fixation system intended for insertion into the medullary canal of a femur in individuals suffering from stable and unstable pertrochanteric, intertrochanteric and subtrochanteric fractures of the femur alone or when these fractures occur in combination with shaft fractures extending distally to a point approximately 10cm proximal to the intercondylar notch. the participant investigators will retrospectively include a maximum of 44 patients meeting inclusion and exclusion criteria (considering an imprecision of 5%) that will contribute for approximately 44 patients in which chimaera was used. the study is designed to analyze medical records of adult patients who underwent chimaera implantation from 2018 to 2023 in the standard clinical practice setting.

Eligibility criteria:
inclusion criteria: 1. the patient expressed his willingness to participate in the study by signing and dating informed consent. 2. patients who had a regular indication for surgical intervention with the long variant of chimaeratm according to the manufacturer's ifu. 3. patients equal or older than 18 years at the time of surgery. 4. patients who underwent surgery performed with chimaeratm. 5. patients with clinical data registered in her/his medical records sufficient to assess the safety and efficacy endpoints of the study. exclusion criteria: 1. patient who had/has a medical condition that is a contraindication according to the manufacturer's ifu leaflet. 2. patient has been diagnosed with bilateral proximal femur fractures. 3. patient who needed the application of, or ha already in-situ a concomitant not permitted device which cannot be safely removed. 4. patient with other concurrent medical or non-medical condition that in the opinion of the participating investigator may prevent participation or otherwise render the patient ineligible for the study. 5. the patient is participating in other clinical studies, or he/she has participated in other clinical studies in the 3 months prior signing the informed consent .

Keywords: intramedullary nail chimaera orthofix fractures femur
a study to evaluate fecal microbiota transplantation engraftment in ibs

Conditions: Irritable Bowel Syndrome

Summary: this is a randomized pilot study to characterize engraftment of a donor's microflora onto patients with irritable bowel syndrome with diarrhea following fecal microbiota transplantation.


Eligibility criteria:
inclusion criteria: * ibs with diarrhea

Keywords: fecal microbiota transplantation
appropriate timing of haart in co-infected hiv/tb patients

Conditions: HIV Infections; Tuberculosis

Summary: to study the optimal timing to initiate antiretroviral therapy in hiv-infected patients who are receiving tuberculosis treatment between at 4 weeks and at 12 weeks after tuberculosis treatment by comparing the composite end point of death rate, hospitalization rate and adverse drug reactions at week 48, 96 and 144.

the growing epidemic of hiv poses a serious public health threat in many countries, including thailand. mortality is clearly reduced in hiv and tuberculosis (tb) co-infected patients who initiate antiretroviral therapy (art) after the treatment of tb, but the optimal timing to initiate art is one of the major concern for patients concurrently receiving both therapies. to date, the prospective, randomized, control trial to study the optimal timing to initiate art in the patients is still limited. in addition, the current recommendation to start art in patients co-infected with hiv and tb is still based on expert opinions. here, the investigators plan to investigate the optimal timing to initiate antiretroviral therapy in hiv-infected patients who are receiving tuberculosis treatment between at 4 weeks and at 12 weeks after tuberculosis treatment by comparing the composite end point of death rate, hospitalization rate and adverse drug reactions at week 48, 96 and 144 at bamrasnaradura infectious diseases institute, ministry of public health, nonthaburi, thailand.

Eligibility criteria:
inclusion criteria: 1. 18-65 years of age 2. hiv-1 infected patients 3. naïve to antiretroviral treatment 4. baseline cd4 cell count \<350 cells/mm3 at enrolment 5. diagnosed as having active tuberculosis by clinical features or positive acid fast stain or positive tb culture; and receiving rifampicin containing antituberculous regimen 6. signed inform consent exclusion criteria: 1. serum transaminase enzymes ≥ 5 times of upper normal limit or total bilirubin ≥ 3 times of upper normal limit 2. serum creatinine ≥ 2 times of upper normal limit 3. lactation or pregnancy 4. receiving any immunosuppressive agents

Keywords: hiv tuberculosis antiretroviral treatment timing
japanese p iii vs voglibose and placebo

Conditions: Diabetes Mellitus, Type 2

Summary: the objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (bi 1356) (5 mg or 10 mg / once daily) compared to placebo given for 12 weeks and voglibose for 26 weeks as mono therapy in patients with type 2 diabetes mellitus with insufficient glycaemic control. furthermore, long-term safety is evaluated with an extension treatment to 52 weeks.


Eligibility criteria:
inclusion criteria: 1. japanese patients with a diagnosis of type 2 diabetes mellitus. antidiabetic therapy has to be stable for at least 10 weeks before visit 1. 2. glycosylated haemoglobin a1 (hba1c) 7.0 - 10.0% at visit 3 (beginning of the 2-week placebo run-in phase) 3. age: \>= 20 and \<= 80 4. body mass index (bmi) \<= 40 kg/m2 exclusion criteria: 1. myocardial infarction, stroke or transient ischemic attack (tia) within 6 months before visit 1 2. impaired hepatic function 3. history of severe allergy/hypersensitivity 4. treatment with anti-diabetic, anti obesity drugs, etc 3 months before visit 1 5. fasting blood glucose \>240 mg/dl (=13.3 mmol/l) at visits 2 or 3
study to assess function and satisfaction of oral ubrogepant in adult participants after multiple migraine attacks in canada

Conditions: Migraine

Summary: migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. this study will evaluate function and satisfaction with oral ubrogepant in treating adult participants after multiple migraine attacks. ubrogepant is a drug approved for the acute treatment of migraine in adults. approximately 167 participants will be enrolled in approximately 10-15 sites across canada. participants will receive ubrogepant as prescribed by their physician according to their routine clinical practice and local label. participants will be followed for up to 12 weeks. there is expected to be no additional burden for participants in this trial. participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.


Eligibility criteria:
inclusion criteria: * participants able to give voluntary informed consent before starting any study-related assessments or procedures (to be obtained/documented as per local regulations). * adults (≥18 years of age) at time of informed consent. * participants with at least 1-year history of migraine with or without aura consistent with a diagnosis according to the ichd-3 (2018). * participants with history of experiencing at least 3 migraine attacks per month with moderate to severe symptoms * participants prescribed ubrogepant by investigator for the acute treatment of migraine according to local product label, independent of and prior to study participation * participants willing and able to comply with the requirements of the study. * participants with access to an electronic device (mobile phone, tablet, laptop, etc.) with internet access. exclusion criteria: * participants previously exposed to a ubrogepant or rimegepant as routine therapy or through a clinical trial. * participants with history of known contraindications to ubrogepant as per local labeling. * participants pregnant or planning to be pregnant or of childbearing potential not using contraception * participants enrolled in any interventional studies that may include investigational compounds for migraine or non-abbvie observational studies. * history or current evidence of any condition that might interfere with their ability to comply with the study requirements, in the opinion of the investigator.

Keywords: migraine ubrogepant ubrelvy
safety of transarterial chemoembolization (tace) in the setting of an elevated bilirubin

Conditions: Hepatocellular Carcinoma; Bilirubinemia

Summary: the aim of this study is to evaluate the safety of selective transarterial chemoembolization (tace) of hepatocellular carcinoma (hcc) in the setting of an elevated total bilirubin, but relatively normal direct bilirubin.


Eligibility criteria:
inclusion criteria: * hepatocellular carcinoma (hcc) * direct or conjugated bilirubin \< 3 mg/dl * total bilirubin \> 3 mg/dl * willing and able to provide informed consent * \>18 years of age exclusion criteria: * currently pregnant * patients who are surgical or ablation candidates as determined by multidisciplinary hepatobiliary tumor conference. * arterial anatomy which would preclude selective transarterial chemoembolization * patients who have a inr or platelet count which are not correctable to \ 35,000 respectively * patients with extrahepatic metastases * patients with portal vein invasion

Keywords: transarterial chemoembolization