Kornimate/medical-research-clean huggingface dataset:
a study to learn about effects of living with covid-19 and the use of the medicines nirmatrelvir-ritonavir in treating covid-19.

Conditions: COVID-19

Summary: the purpose of this study is to learn about: * effects of living with covid-19 and * how effective is nirmatrelvir-ritonavir in treating covid-19. this is a study of two groups of covid-19 patients in taiwan. in group 1 the below participants were included in the study: * patients of all ages. * patients who were confirmed to have covid-19 infection between 01 january 2021 and 31 december 2021. * cases of patients registered in the databases. in group 2 the below participants were included in the study: * participants who are 12 years or older. * confirmed to have covid-19 between 01 january 2022 and 31 december 2022. nirmatrelvir-ritonavir is taken by mouth and is used to treat covid-19. the study will look at: * the nature of covid-19 disease. * as well as the experiences of people receiving the nirmatrelvir-ritonavir. this study will help to: * understand what type of patients will need to be admitted to hospitals. * see severe results due to covid 19 infection. * have more knowledge on the use of nirmatrelvir/ritonavir on covid-19.


Eligibility criteria:
cohort 1: inclusion criteria: * patients of all ages * patients with a diagnosis of covid-19 infection between 01 january 2021 and 31 december 2021 * cases of patients registered in the databases exclusion criteria: * patients without covid-19 diagnosis cohort 2: inclusion criteria: * ≥12 years of age * have covid-19 diagnosis with international classification of diseases (icd) code between 01 january 2022 and 31 december 2022 exclusion criteria: * patients without covid-19 diagnosis

Keywords: covid-19 real world evaluation on covid-19 burden
cd19-targeting 3rd generation car t cells for refractory b cell malignancy - a phase i/iia trial.

Conditions: B Cell Lymphoma; B Cell Leukemia

Summary: chimeric antigen receptor (car) t cells targeting cd19 will be evaluated for safety and efficacy in patients with b cell lymphoma or leukemia. the car consists of a cd19 targeting antibody scfv with three intracellular signaling domains derived from cd3 zeta, cd28 and 4-1bb. autologous t cells will be gene engineered with the car gene using a retrovirus vector. prior to t cell infusion, the patients will be subjected to preconditioning treatment. after t cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of car t cells and efficacy.


Eligibility criteria:
inclusion criteria: * relapsed or refractory cd19+ b-cell lymphoma or leukemia. * measurable disease. * performance status ecog 0-2. * \>18 years old. * fertile females/males must consent to use contraceptives during participation of the trial. * signed informed consent. exclusion criteria: * any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures. * patients with primary cns lymphoma. * known human immunodeficiency virus (hiv) infection. * active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis b virus (hbv) or active hepatitis c virus (hcv) infection). * other serious underlying medical conditions, which, in the investigator's judgment, could impair the ability of the patient. * treatment with an investigational product within 30 days prior to enrollment, or at least 5 half lives of that drug, which is longest. * patients that do not consent to that tissue and blood samples are stored in a biobank. * pregnancy
maternal oxygen supplementation for intrauterine resuscitation

Conditions: Fetal Distress; Fetal Hypoxia; Labor and Delivery Complication

Summary: more than 80% of the 3 million women who labor and deliver each year in the united states undergo continuous electronic fetal monitoring (efm) during labor in order to fetal hypoxia and prevent the transition to acidemia, expedited operative delivery, and/or neonatal morbidity. category ii efm is the most commonly observed group of fetal heart rate features in labor. one common response to category ii efm is maternal oxygen (o2) supplementation. the theoretic rationale for o2 administration is that it increases o2 transfer to a hypoxic fetus. there are conflicting national guidelines regarding o2 administration - the american college of obstetricians and gynecologists suggest o2 is ineffective, whereas the association of women's health, obstetric, and neonatal nurses recommend continued use given lack of definitive data on safety and efficacy. a recent national survey of nearly 600 labor \& delivery providers in february 2022 revealed that 49% still use o2 . thus, there remains equipoise on the topic and high-quality data on the safety of intrapartum o2 is needed. none of the trials to date have studied the effect of intrapartum o2 on important clinical measures of neonatal or maternal morbidity. this safety data is imperative because the field of obstetrics must hold supplemental o2 to the same rigorous standards applied to any drug used in pregnancy. without data on these definitive outcomes, it will be challenging to implement evidence-based recommendations for supplemental o2 use on labor \& delivery. the investigators will conduct a large, multicenter, randomized noninferiority trial of o2 supplementation versus room air in patients with category ii efm in labor.


Eligibility criteria:
inclusion criteria: * singleton gestation * gestational age\>=37 weeks * spontaneous labor or induction of labor * english or spanish speaking * planned continuous fetal monitoring exclusion criteria: * preterm gestation * major fetal anomaly * multiple gestation * category iii fetal monitoring at time of admission * maternal hypoxia \<95% * planned or scheduled cesarean delivery excluded from randomization if receiving nitrous oxide for analgesia at time of randomization.
neuropsychological evaluation for early diagnosis of psp

Conditions: Progressive Supranuclear Palsy; Cognitive Impairment

Summary: the aim of this study is to better understand the nature of the cognitive decline in progressive supranuclear palsy, the time of its development and the relation with the other cardinal features of the disease.

progressive supranuclear palsy (psp) is a neurodegenerative disease characterized by vertical supranuclear gaze palsy, early balance dysfunction and falls. tau-protein aggregation, mainly in the brainstem, is the disease hallmark. because of the similarities with parkinson's disease (pd), the diagnosis is made approximately 4 years after the symptoms onset. cognitive deficits are a leading feature of psp and they actually represent one of the four functional core domains in the revised diagnostic criteria. the aim of this study is to better understand the nature of this cognitive decline, the time of its development and the relation with the other cardinal features of the disease.

Eligibility criteria:
inclusion criteria: * patients fulfilling the criteria for idiopathic pd * patients fulfilling the criteria for psp exclusion criteria: * any other neurodegenerative disorders or medical conditions different from pd / psp
anti-glomerular basement membrane disease

Conditions: Anti-Glomerular Basement Membrane Disease

Summary: this study aims to clarify the prognosis of the rare but severe condition anti-glomerular basement membrane disease (anti-gbm disease also known as goodpastures disease). specifically, we aim to investigate how the prognosis is affected by treatment options and disease severity at presentation measured using biomarkers in blood and urine. the study has two arms, one focusing on treatment (a) and one focusing on biomarkers (b). data from a research subject (patient) can be included in both arms. for inclusion in arm a patients must be diagnosed after 01-01-2010 with available information about treatment and the participating clinic must have a search strategy enabling inclusion of \> 80% of their patients. for inclusion in arm b there is no time limit, but there must be blood and/or urine samples available from the time of diagnosis and information about if the patient was alive six months after diagnosis. due to the rarity of anti-gbm disease, very few clinical trials have been conducted. instead, available information comes from observational studies, most of which are relatively small and/or includes patients treated during the previous millenium, sometimes with sparse information about treatment. with this study we aim to collect more information about initial treatment. today, treament is based on three pharmaceutical groups; corticosteroids, cytotoxic agents and plasma exchange. presently available data indicates that all three groups are needed, but all three can be used with variations in administration and intensity. at this time, it is not clear how intense the treatment needs to be, while it is clear that an intense treatment increases the risk of infections. at present, two factors seem to be able to predict the possibility to preserve kidney function; kidney function at diagnosis measured as plasma creatinine concentration and the degree of kidney damage measured as the proportion of healthy renal corpuscles (glomeruli) in a tissue sample (biopsy). there is also data indicating that the amount of anti-gbm autoantibodies is prognostic, but this is less clear. in recent years, several other types of autoantibodies such as anti-laminin and anti-myeloperoxidase has been proposed to affect prognosis, but their importance remains unclear. likewise, autoantibody characteristics such as subclass and exact binding site, can be evaluated, but the clinical significance of this is not known. this is also the case for markers of inflammation and renal damage in blood and urine.


Eligibility criteria:
arm a: inclusion criteria: * anti-gbm disease diagnosed 01-01-2010 - 31-12-2027 * available information about initial treatment arm b: inclusion criteria: * anti-gbm disease diagnosis (no time limit) * available blood and/or urine sample at the time of diagnosis * available information about patient survival at six months
the global vitamin d study. a genomic, transcriptomic, proteomic and metabolomic approach

Conditions: Vitamin D Deficiency

Summary: the effect of vitamin d supplementation on genetic, proteomic , and metabolomic profile in adipose tissue will be studied in 50 subjects.

vitamin d is a hormone with effects not only on the skeleton, but on most tissues in the body. lack of vitamin d is associated with coronary heart disease, cancer and immunological diseases, and also with obesity, hypertension and glucose intolerance. however, to see the full effect of vitamin d, one should not only look at single diseases or risk factors, but have a global approach using a combined clinical index. a similar line of thinking can be applied to genetic, proteomic and metabolomic studies on vitamin d. thus, in the present study 50 subjects will be included and randomized to vitamin d 40.000 iu per week versus placebo for 2 months. blood and adipose tissue samples will be collected before and after the intervention and analyzed for gene expression. based on these results the investigators will proceed with the relevant proteomic and metabolomic profile analyses. if successful, this may reveal new aspects of vitamin d's physiology and metabolic effects.

Eligibility criteria:
inclusion criteria: * serum 25ohd in the range 20 - 40 nmol/l * no change in medication last 4 weeks exclusion criteria: * women \< 60 yrs of age (to avoid influence of menstrual cycle) * reduced kidney function * serious diseases (cardio-vascular, diabetes, etc) * taking vitamin d supplementation

Keywords: vitamin d genomics proteomics metabolomics adipose tissue
a retrospective evaluation of superficial radiation therapy (srt) and keloid scars.

Conditions: Keloid Scar

Summary: keloid formation in response to skin trauma inflicts about 18 million individuals. a key impediment in successful treatment of keloids is that the predominant treatments, particularly surgical excision and shaving, tend to initiate the regrowth of the keloid at the excision site, and therefore, recurrence rates are high. there is much evidence to demonstrate that following surgical excision procedures with a course of radiation therapy can significantly reduce recurrence rates to as little as 10% or below. this retrospective study is to evaluate this claim.

a keloid is an unsightly non-malignant tumor comprised of an abnormal proliferation of scar tissue that forms at the site of cutaneous injury (e.g. skin trauma such as cuts, abrasions and puncture wounds, burns or surgical incisions). it appears as a raised scar and does not regress and grows beyond the original margins of the scar. keloids most commonly develop on the earlobes, neck, shoulders, chest, back, upper arms and cheeks. keloids tends to grow slowly and continue to spread for weeks, months or even years. as a keloid grows, it may cause significant itching, pain, and tenderness upon touch, reduced mobility and emotional distress. about 18 million people worldwide are genetically prone to form keloids in response to skin trauma, with equal gender distribution and greater susceptibility for darker-skinned individuals and those aged 10 to 30 years. the greatest obstacle in treating keloids with many available surgical and non-surgical methods is that new keloids typically recur at the site of excision due to the treatment itself. for example, the recurrence rate using surgical excision alone is 45 to 100 percent. surgical excision followed by radiotherapy is a helpful treatment option for large and more difficult-to-treat keloids that cannot otherwise be treated by, or have failed, more conservative measures. it is thought that because keloid fibroblasts are sensitive to x-ray irradiation, it may prevent the recurrence of keloids by controlling fibroblast proliferation, arresting the cell cycle, and inducing premature cellular senescence. when surgical keloid excision is followed by radiation therapy, recurrence drops dramatically to 10% or below. the srt-100™ is a united states food and drug administration (u.s. fda) approved device for delivering a precise, calibrated dose of superficial radiation therapy (srt) to treat keloids caused by surgery or injury. this retrospective study has been designed to focus on efficacy and safety of the srt-100™ for the treatment of recurrent keloid scars.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of keloid(s). * treatment with srt-100™ of one or more keloids. * at least 1 year since treatment end. * required retrospective data is existing and sufficient. exclusion criteria * lesions of etiology other than keloids.
a phase i clinical trial to evaluate the effect of renal impairment on pharmacokinetics of nox-e36

Conditions: Renal Impairment

Summary: this is a multi center, open label, parallel group, single administration, phase i trial, in subjects with mild, moderate or severe renal impairment and a control group with normal renal function.

current diabetes therapy does not stop progression of the disease and the development of diabetes mellitus (dm)-associated complications. a major concern in dm-patients is renal impairment due to nephropathy leading to a reduced glomerular filtration rate (gfr). it has been established that chronic (sub)clinical inflammation is crucial for the onset and progression of dm. ccl2, also known as monocyte chemoattractant protein 1 (mcp 1) is a chemokine from the cysteine-cysteine family, secreted by leukocytes or tissue cells. ccl2 promotes monocyte emigration from the bone marrow, activates monocytes and macrophages and directs their migration to sites of inflammation. recent animal studies and clinical trials indicate a critical involvement of ccl2 in dm and diabetic nephropathy, suggesting that ccl2 may be a potential target for therapeutic intervention in dm. finally, protein overload and oxidative challenge of the diseased kidney was suggested to stimulate ccl2 expression in renal tubuli, thereby accelerating the progression of diabetic nephropathy. as nox e36 is designed to specifically target human mcp-1/ccl2. this study is performed to evaluate the role of renal impairment for adequate dosing recommendations in the planned target population.

Eligibility criteria:
inclusion criteria: 1. male and female subjects (age 18-75 years, both inclusive) 2. male subjects who agree to sexual abstinence and/or use a highly effective method of birth control. female partners of male subjects must be of non-child bearing potential or must practice an adequate non-hormonal contraceptive method to prevent pregnancies. 3. subjects will be categorized as follows based on creatinine clearance(ml/min/1.73m2): normal renal function: crcl \> 80; mild renal impairment: 50 ≤ crcl ≤ 80; moderate renal impairment: 30 ≤ crcl ≤ 50; severe renal impairment: crcl \< 30 4. body mass index (bmi) between 22 and 40 kg/m², both inclusive. exclusion criteria: 1. women of childbearing potential 2. patients who have received kidney transplantation. 3. patients receiving hemodialysis to control their disease. 4. any clinically significant abnormality other than related to the renal impairment following the investigator's review of the physical examination, ecg and clinical laboratory tests at screening. 5. not able to communicate meaningfully with the investigator and staff.

Keywords: renal impairment nox-e36
effect of acetazolamide on right heart function during exercise in lowlanders older than 40 years at altitude

Conditions: Altitude Hypoxia

Summary: randomized, placebo controlled trial evaluating efficacy of acetazolamide on right heart function during exercise in lowlanders older than 40 years travelling from 760 m to 3'100 m.

this is a randomized, placebo-controlled, double-blind parallel trial evaluating the efficacy of acetazolamide prophylaxis on right heart function during exercise in lowlanders older than 40 years travelling to altitude. participants living in the bishkek area, kyrgyzstan (760m), will be transferred by car within 4h to the tuja ashu high altitude clinic (3'100 m), and stay there for 2 days. acetazolamide 375mg/day (or placebo), will be administered before departure at 760 m and during the stay at altitude. outcomes will be assessed during the stay at 3'100 m. an interim analysis will be carried out when 200 participants will have completed the study and/or after the first year. the peto's method will be used and the trial will be stopped when pre-specified futility boundaries were crossed.

Eligibility criteria:
inclusion criteria: * healthy men and women, age 40-75 yrs, without any disease and need of medication. * born, raised and currently living at low altitude (\<800m). * written informed consent. * kyrgyz ethnicity exclusion criteria: * any active respiratory, cardiovascular or other disease requiring regular treatment or being otherwise relevant for tolerance of hypoxia or altitude exposure. * any condition that may interfere with protocol compliance including current heavy smoking (\>20 cigarettes per day or \>20 pack-years with active smoking during the last 10 years), regular use of alcohol. * allergy to acetazolamide and other sulfonamides.

Keywords: healthy participants older than 40 years right heart function during exercise prevention acetazolamide
observational study on the outcome of patients with itp who underwent splenectomy after 2010

Conditions: Primary Immune Thrombocytopenia

Summary: retrospective data collection on itp patients who underwent splenectomy from 01/01/2010 to 12/31/2022. the expected enrollment period is 6 months. the observation period of the enrolled patients is at least 1 year.

observational, longitudinal, retrospective study on itp patients. patients with itp who underwent splenectomy from 01/01/2010 to 12/31/2022 will be enrolled. all useful data will be collected exclusively through consultation of outpatient medical records. the expected enrollment period is 6 months. the observation period of the enrolled patients is at least 1 year.

Eligibility criteria:
inclusion criteria: * patients aged ≥ 18 years * patients with primary itp according to international criteria \[2\], who underwent to splenectomy from 01/01/2010 to 12/31/2022. * obtaining informed consent. exclusion criteria: * none

Keywords: splenectomy
assessing prevalence of beta lactamase production from clinical isolates of hospitalized patients and comparison of antibiotic susceptibility patterns

Conditions: Infection

Summary: egast 2008 is a prospective, non interventional, multicentric study (approximately 2000 isolates from 15- 20 sites). objectives: * comparison of antimicrobial susceptibility using disc-diffusion method * assessing prevalence of beta-lactamase producing strains among clinical isolates obtained from hospital in-patients

n/a n/a

Eligibility criteria:
inclusion criteria: isolates (as specified in the observational plan) from hospitalised patients exclusion criteria: isolates obtained from outpatients will not be included for the study. isolates from repeat cultures performed during in-patient follow-up that were previously recruited into the study will be excluded. isolates identified as commensals or contaminants will be excluded

Keywords: antibiotic susceptibility; beta lactamase; esbls
telehealth-massed imaginal exposure for ptsd

Conditions: Posttraumatic Stress Disorder

Summary: the purpose of this study is to establish the safety, feasibility, and acceptability of very brief imaginal exposure therapy for post-traumatic stress disorder (ptsd) delivered by telehealth over the course of six-daily 60-minute sessions within a 10-day window. all study visits occur remotely, by telehealth. you will be asked to complete a pre-treatment assessment involving a clinical interview, video-based measures of emotional and physical reactions, such as heart rate and breathing rate, and self-report questionnaires to measure the severity and impact of trauma-related symptoms. these assessments are completed again 1-week, and 1-month after completing treatment. the researchers propose that massed exposure-based therapy delivered via telehealth will advance telemental health treatment options and personalized care for veterans with ptsd.


Eligibility criteria:
inclusion criteria: * age 18-65. * ability to speak, read, and write english. * diagnosis of ptsd based on caps-5 (\> 3 mo. post-trauma). * seeking treatment for ptsd at the charleston va. * willingness and ability to engage in assessment and treatment visits through vvc, or another va-approved telehealth videoconferencing platform. exclusion criteria: * currently receiving psychotherapy for another anxiety- or stress-related condition. * current substance use disorder diagnosis with repeated abuse or dependence within 3 months of study entry and unwillingness to abstain for 24 hours prior to study visits. * unstable dose of psychotropic medications within 6 weeks prior to baseline assessment (based on the dmsc; see measures). * medical condition that would contraindicate participation in treatment or assessment activities (e.g., severe cardiovascular problems; dmsc, and chart review; see measures). * current, or history of bipolar i disorder * current, or history of psychotic symptoms * serious suicidal risk or a suicide attempt in the past year, as determined by self-report (phq-9) and clinical interview (c-ssrs; see measures). * active neurological conditions, e.g., seizures, stroke, loss of consciousness or concussion (dmsc, and chart review; see measures)

Keywords: veterans