Kornimate/medical-research-clean huggingface dataset:
tdcs-potentiated generalization of cognitive training in the rehabilitation of long covid symptoms

Conditions: Post-acute Sequelae SARS-CoV-2 Infection (PASC)

Summary: the overarching goals of this study are to employ cognitive testing to understand how transcranial direct current stimulation (tdcs), when used concurrently with cognitive training tasks, can affect cognitive impairment symptoms in individuals with long covid, or post-acute sequelae sars-cov-2 infection (pasc), and to examine variability in response between active and sham tdcs treatment groups.


Eligibility criteria:
inclusion criteria: * ability to provide consent and comply with study procedures * age 18 to 60 years old * estimated iq within the specified range (70 \&lt;= iq e \&lt;= 115) * current post-acute sequelae sars-cov-2 infection (pasc) as defined by the national center for health statistics post-covid-19 conditions survey ((long covid 2022), including impaired cognition symptoms, for at least 3 months post-infection * ability to participate in four weekly 40' training sessions over four weeks and participate in two assessments * english speaking exclusion criteria: * any medical condition or treatment with neurological sequelae (e.g. stroke, tumor, loss of consciousness \&gt;30 min, concussion involving hospital admission, hiv) * contraindications for tdcs (e.g. history of seizures) * five or more sessions of neuromodulation (such as tdcs) or cognitive training in the past 6 months
clinical study of cll1 car-t cells in the treatment of hematological malignancies

Conditions: AML

Summary: clinical study on the safety and effectiveness of cll1 car-t cells in the treatment of cll1-positive hematological malignancies

human c-type lectin-like molecule 1 (cll1) is a type ii transmembrane glycoprotein ，cll1 expression is restricted to bone marrow cells and most aml blasts. in addition, cll1 is expressed in leukemia stem cells (lsc) but not in hematopoietic stem cells (hsc), may provide a potential therapeutic target for the treatment of aml.the car-t cell injection uses immune cells from healthy donors, and is the final product obtained after car genetic modification, cell expansion, culture, screening, preparation, sub-packaging, and release inspection. the center intends to apply for a clinical trial of cll1 car-t cells to treat cll1-positive hematological malignancies on the basis of preliminary research.

Eligibility criteria:
inclusion criteria: * 1. patients is histologically diagnosed with cll1-positive aml according to the nccn clinical practice guidelines in oncology：acute myeloid leukemia（version 2.2021） 2. the diagnosis is consistent with r/r cll1 + aml, and includes any of the following conditions: 1. no cr was obtained after 2 courses of standard chemotherapy 2. the first induction was cr, but the duration of cr was less than 12 months 3. no cr was obtained after the first or multiple remedial treatment; 4. relapse twice or more; 3. the number of blast cells in bone marrow was more than 5% (morphology) and / or \> 1% (flow cytometry). 4. no active lung infection, inhaled air oxygen saturation ≥92% 5. the estimated survival time is more than 3 months 6. ecog score was 0-2 7. the patients or their legal guardians voluntarily participated in the trial and signed the informed consent. exclusion criteria: * 1. patients with history of epilepsy or other central nervous system diseases; 2. patients with prolonged qt or severe heart disease; 3. pregnant or lactating women (the safety of this therapy for unborn children is unknown); 4. the patients with uncontrolled active infection; 5. active hepatitis b or hepatitis c virus infection; 6. previous application of gene therapy; 7. the proiferation rate is less than 5 times response to cd3/cd28 co-stimulation signal; 8. serum creatinine \> 2.5mg/dl or alt / ast \> 3 times uln or bilirubin \> 2.0mg/dl; 9. those who suffer from other uncontrolled diseases are not suitable to join the study; 10. hiv infection; 11. any situation that the researchers believe may increase the risk of patients or interfere with the test results.

Keywords: aml cll1 car t-cell therapy
covid-19 patients with hypertension and/or kidney diseases

Conditions: COVID-19; Hypertension; Kidney Diseases

Summary: 1. correlation between covid-19 and hypertension and/or kidney diseases. 2. assess assess the effect of covid-19 on patients with hypertension and/or kidney diseases. 3. assess the effect of hypertension and/or kidney diseases on covid-19 presentation. 4. assess the outcome of covid-19 in patients with hypertension and/or kidney diseases

the pandemic situation with the emergence of severe acute respiratory syndrome coronavirus 2 (sars-cov-2) from china has endangered human lives. coronavirus disease 2019 (covid-19) is presented with asymptomatic, mild, or severe pneumonia-like symptoms¹.sars-cov-2 has infected humans in all age groups, of all ethnicities, both males and females while spreading through communities at an alarming rate². covid-19 patients with hypertension, chronic kidney disease, diabetes, malignancies, hiv, and other comorbidities could develop a life-threatening situation. from the data have reported the characteristics of comorbidities in patients with covid-19, hypertension was present in nearly 21%, followed by diabetes in nearly 11%, and established cardiovascular disease (cvd) in approximately 7% of patients³. hypertension posed an increased risk of severe morbidity (approx. 4-fold) and death (approx. 7-fold) from covid-19 in the presence of multiple comorbidities⁴. the patients with underlying kidney problems are vulnerable to developing covid-19 infection.the disease also has had consequences on longitudinal management of patients with chronic kidney disease and end stage kidney disease.

Eligibility criteria:
inclusion criteria: patients above 18 years old. patients who diagnosed as covid-19 pcr positive with hypertension and/or kidney diseases. exclusion criteria: young patients below 18 years old. patients who refused to participate in reseach
cell therapy by bone marrow-derived mononuclear cells (bmc) for large bone defect repair: phase-i clinical trial

Conditions: Humerus Fracture Displaced Proximal

Summary: in the present phase-i clinical trial we investigate safety and feasibility of an augmentation with preoperatively isolated autologous bmc cells seeded onto ß-tcp in combination with an angle stable fixation (philos plate®) for the therapy of proximal humeral fractures.


Eligibility criteria:
inclusion criteria: * patients aged between 50. and 90. years with proximal humerus fractures * indication for open reposition and internal stabilisation with a proximal fixed- angle plate for humerus (philos, synthes, oberdorf, swiss): * 2-, 3- or 4-fragment fracture according to neer * dislocation of \>10 mm between fragments and/or * angle of \> 45° between fragments and/or * dislocation of tuberculum major \> 5 mm * negative pregnancy test of premenopausal women * signed informed consent for surgery and participation in the clinical trial exclusion criteria: * contraindications against administration of investigational medicinal product (imp) is pregnancy and nursing * dislocation fracture * known psychic disorder that leads to incompliance (e.g. dementia, schizophrenia, major depression) * pathologic fractures caused by other underlying diseases * fracture-induced nerve damage * tumor disease with recent adjuvant therapy or treatment during the last 3 months (e.g. chemotherapy, radiotherapy), untreated tumor diseases * known hypersensibility against components of the transplant * participation in a clinical trial during the last 3 months prior to this study

Keywords: large bone defect, bone marrow-derived mononuclear cells
evaluating dose-proportionality of dilatrend suspended-release capsule

Conditions: Chronic Stable Angina

Summary: this study is designed to evaluate dose-proportionality of dilatrend sr 8mg, 16mg, 32mg, 64mg, 128mg in healthy male volunteers.


Eligibility criteria:
inclusion criteria: 1. age range 20 to 54 years, body mass index of ≥19 and ≤26 healthy male volunteers 2. able to participate in all procedure 3. sbp 90-140 mmhg, dbp 60-90 mmhg, pulse rate 55-95 times/min 4. have given written informed consent exclusion criteria: 1. have history of significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, musculoskeletal neurologic disease 2. have history of gastrointestinal disease(crohn's disease, gastrointestinal ulcer) or surgery(except for appendectomy, hernia) 3. have allergy or hypersensitivity to carvedilol or any component of the formulation(aspirin, antibiotics) 4. have history of drug abuse. a positive test for any drug(amphetamine, barbiturates, cocaine, opiates, benzodiazepines, thc, methadone, ect.) included in the urine drug screen. 5. have herbal drug within 30days prior to the first ip administration, have etc within 14days prior to the first ip administration, have otc 7days prior to the first ip administration. 6. have diet which may influence on the absorption, distribution, metabolism or excretion of drug(s), (drinking over 1l of grapefruit juice within 7days prior to the first ip administration) 7. have received an investigational drug within 60 days prior to the first ip administration 8. have donated whole blood within 60 days prior or donation plasma within 30 days prior to the first ip administration 9. have any metabolic enzyme including or inhibiting drugs like barbiturates within 30 days prior to the first ip administration. 10. a heavy caffeine/alcohol consumer or a heavy smoker(caffeine \> 5 units/days. alcohol \>21 units/week (1 unit=pure alcohol 10ml), cigarette \> 10 cigarettes/day) or alcohol abuse. 11. positive for hepatitis b, hepatitis c, hiv or syphilis
twelve month clinical evaluation of kerasoft ic soft contact lenses

Conditions: Keratoconus

Summary: the objective of this twelve month dispensing study is to evaluate the clinical performance, particularly comfort and vision, of kerasoft ic soft contact lenses.


Eligibility criteria:
inclusion criteria: * have participated and completed a previous study (roc2-10-078). * is keratoconic exclusion criteria: * has any systemic disease affecting ocular health. * is using any systemic or topical medications that will, in the investigator's opinion, affect ocular physiology or lens performance. * is not correctable to 20/50 or better in each eye with contact lenses. * has greater than grade 2 slit lamp exam findings. * has any atypical scar for a keratoconic or neovascularization within the central 4mm of the cornea. subjects with minor peripheral corneal scarring that, in the investigator's judgment, does not interfere with contact lens wear are eligible for this study. * has any neovascularization within the central 4mm of the cornea.
effect of atazanavir-ritonavir on the pharmacokinetics and toxicity of lumefantrine

Conditions: Drug Interaction

Summary: a case control pharmacokinetic study evaluating the effects of atazanavir-ritonavir on the pharmacokinetics and toxicity of lumefantrine in people living with hiv attending apin clinic of the lagos university teaching hospital

atazanavir-ritonavir (atvr) based antiretroviral therapy and artemether-lumefantrine (al) are commonly used drugs for the treatment of human immune deficiency virus (hiv) infection and malaria respectively in nigeria. however, both drugs interact with cytochrome p 3a4 (cyp 3a4) isoenzymes which may spawn clinically significant pharmacokinetic interactions. the study was aimed at evaluating the effects of atazanavir-ritonavir on the pharmacokinetics and toxicity of lumefantrine. in a case control pharmacokinetic study, twenty participants who tested positive for plasmodium falciparum malaria were recruited and divided into two groups (atvr-arm, n=10; and control-arm, n= 10). all the participants were administered with 6 doses of al 80-480 mg (coartem). thereafter, blood samples were collected from them at different time intervals over seven days. the lumefantrine concentration in each sample was determined with high-performance liquid chromatography (hplc) and entered into winnonlin® software to determine the pharmacokinetic parameters of lumefantrine which were compared between the test and control groups. toxicity was evaluated with adverse events monitoring, electrocardiography, haematological and blood chemistry tests at pre and post doses of artemether-lumefantrine.

Eligibility criteria:
inclusion criteria: * adult male or non-gravid female ≥18 years of age, * informed written consent, * malaria parasitaemia * axillary temperature ≥37.5°c or history of fever within 24 hours before visiting the clinic and with, at least, any of the following signs and symptoms of uncomplicated malaria: chills, sweats, headaches, muscle aches, nausea, vomiting, diarrhoea, body weakness, poor appetite and pallor. * hemoglobin (hb) ≥8 g/dl * body weight ≥35 kg * hiv positive (atvr arm), hiv negative (al/control arm) exclusion criteria: * severe anaemia' (haemoglobin levels \< 8g/dl) * smokers/alcoholics and users of substances which inhibit or induce cyp3a4 iso enzymes * withdrawal of consent * known allergy to any of the study drugs * development of complications or severe adverse effects * smokers/alcoholics and users of caffeine, drugs which induce or inhibit cyp3a4 and cyp2b6 * evidence of chronic illnesses such as diabetes, hypertension, psychiatric illnesses * subject taking any drugs or having any condition known to prolong qt-intervals * signs of severe malaria * use of anti-tubercular drugs for at least three months prior to enrolment * being on anti-malarial drugs within four weeks prior to enrolment * pregnant or nursing mother.

Keywords: drug interaction, artemether-lumefantrine, atazanavir-ritonavir, luth
smoking and body weight: analysis of hhanes

Conditions: Cardiovascular Diseases; Heart Diseases

Summary: to evaluate the relationships between smoking rate, gender, and body weight in the hispanic health and nutrition examination i survey (hhanes) i. also, to evaluate the independent and additive contribution of smoking rate and fasting glucose on body weight in hhanes i and nhanes ii.

background: the study was supported by the small grants program established by the national heart, lung, and blood institute in january 1990 to provide limited support to extend analyses of research data generated by clinical trials, population research, and demonstration and education research studies. design narrative: the first study used hhanes i data and analysis of variance to determine the possible body composition differences between subgroups of gender and smoking categories. caloric differences in dietary intake were analyzed in a second anova design. the second study used data from hhanes i and nhanes ii to evaluate the independent and additive or synergistic contribution of smoking rate and fasting glucose on body weight.

Eligibility criteria:
no eligibility criteria
gore viabahn endoprosthesis versus percutaneous transluminal angioplasty (pta) to revise av grafts in hemodialysis

Conditions: Renal Failure; Hemodialysis

Summary: the objective of the study is to establish efficacy and safety of the gore viabahn® endoprosthesis with propaten bioactive surface when used to revise arteriovenous (av) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis.

the primary effectiveness hypothesis is to demonstrate that the gore viabahn® endoprosthesis with propaten bioactive surface will extend the period of target lesion primary patency as compared to pta. the primary safety hypothesis is to demonstrate that the proportion of subjects remaining free from major device, procedure, and treatment site-related adverse events through 30 days post-procedure in the gore® viabahn® device group is not inferior to that of the pta group.

Eligibility criteria:
inclusion criteria: * hemodialysis patient with a dysfunctional or thrombosed forearm or upper arm prosthetic vascular access graft. * the target lesion starts less than or equal to 30 mm from the venous anastomosis. * the target lesion has \> 50% stenosis as measured per protocol. * the patient has a maximum of one secondary stenosis. exclusion criteria: * the age of the hemodialysis access graft is less than or equal to 30 days old from the date of the study procedure. * the patient has undergone an intervention (surgical or percutaneous) of the vascular access circuit less than or equal to 30 days from the date of the study procedure. * the secondary lesion is an occlusion.

Keywords: hemodialysis stent graft venous anastomosis arteriovenous grafts
spi-1005 for the treatment of meniere's disease

Conditions: Meniere Disease; Ménière

Summary: the study is a randomized, double-blind, placebo-controlled, multi-center clinical trial (rct) with open-label extension study (ole), of spi-1005 in adult subjects with definite meniere's disease with active symptoms within three months preceding study enrollment.


Eligibility criteria:
inclusion criteria: * adult males/females, 18-75 years of age at the time of enrollment. * diagnosis of definite meniere's disease by aao-hns amended 2015 criteria. * hearing loss of ≥30 db at 250, 500, or 1000 hz at study enrollment. * at least two of three active symptoms (tinnitus; aural fullness; vertigo or dizziness) of meniere's disease by aao-hns amended 2015 criteria, within 3 months of study enrollment. exclusion criteria: * current, or within 60 days prior to study enrollment, use of iv ototoxic medications * history of otosclerosis or vestibular schwannoma. * history of significant middle ear or inner ear surgery in the affected ear. * conductive hearing loss with air-bone gap ≥15 db, otitis media, or mixed hearing loss. * significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, neurological, or psychiatric disease. * current use or within 30 days prior to study enrollment systemic steroids. * current use or within 7 days prior to study enrollment intratympanic steroids.

Keywords: ebselen hearing loss tinnitus vertigo dizziness spi-1005
immunogenicity, safety and tolerability of the typhoid fever vaccine candidate m01zh09 in healthy adults

Conditions: Typhoid

Summary: this study is to investigate the safety, tolerability and immunogenicity of the typhoid fever vaccine candidate m01zh09 manufactured at commercial scale, at a new manufacturing facility. the vaccine will be delivered as a single oral dose to healthy, typhoid vaccine-naïve adults.

this was a randomised, double-blind, placebo-controlled, single dose, dose escalation study with 4 dosing cohorts. within each cohort, 45 evaluable subjects were planned (36 subjects receiving m01zh09, 9 receiving placebo).

Eligibility criteria:
inclusion criteria: * healthy adult subjects aged 18 to 50 years inclusive, who are able and willing to give informed consent, following a detailed explanation of participation in protocol * available for the duration of the study and available for scheduled and potential additional visits exclusion criteria: * women who are pregnant, breast-feeding or of childbearing potential and unwilling to use a reliable method of contraception throughout the study period * history of anaphylactic shock following vaccination by any route have phenylketonuria * hypersensitivity to any component of the vaccine or are hypersensitive to two of the following antibiotics: ciprofloxacin, azithromycin, ampicillin, trimethoprim sulfamethoxazole * received antibiotic medication within 14 days prior to dosing * received any vaccine within 4 weeks prior to dosing or plan to receive a vaccine within 4 weeks after dosing * received any vaccine against salmonella typhi (licensed or investigational) or ever suffered from typhoid fever * subjects who test positive for hepatitis b, hepatitis c, hiv or human leucocyte antigen b-27 * known or suspected history of liver or active gall bladder disease, ongoing gastro-intestinal disease or abnormality * commercial food handlers or health care workers with direct contact with high risk patients or who have household contacts with immuno-compromised individuals, pregnant women or children less than 2 years of age * subjects who have a clinically significant amount of protein or haemoglobin in their urine or abnormality of their haematology or serum biochemistry parameters * impairment of immune function or those receiving or have received cytotoxic drugs in the 6 months prior to study entry * subjects who use antacids, proton pump inhibitors or h2 blockers on a regular basis or have consumed proton pump inhibitors or h2 blockers within 24 hours prior to dosing * acute infections (including fever of 37.5 degrees celsius or greater) on the day of dosing. * subjects with chronic disease (e.g crohn's disease, inflammatory bowel disease, diabetes) who cannot withstand a 3 hour fast * substance abuse or a history of substance abuse that might interfere with participation in the study * body mass index (bmi) is less than 19 or greater than 34 kg per m2 * clinically significant medical condition that precludes participation in the study * subjects who have participated in an interventional clinical trial within 60 days of dosing
syndrome and aspiration pneumonia in intensive care

Conditions: ICU Patients; Under Mechanical Ventilation; In State of Coma (Define by Glasgow ≤ 8); No Antibiotic Treatment

Summary: inhalation is a common condition in patients with impaired their awareness requiring protection of the upper airway by endotracheal intubation. this inhalation may lead to chemical pneumonitis and/or bacterial pneumonia. only the latter requires the administration of antibiotics. patients developing such a bacterial pneumonia, has a mortality, duration of mechanical ventilation and length of icu stay increased. however, the proportion of patients with such bacterial pneumonia, bacterial ecology and morbidity that are little known. the aim of this study is to determine the frequency of bacterial pneumonia in patients admitted to the icu for coma and treated with mechanical ventilation


Eligibility criteria:
inclusion criteria: * altered consciousness defined by a glasgow coma scale score less than or equal to 8 before protection of the upper airway by endotracheal intubation * patient under mechanical ventilation exclusion criteria: * patient with pre-existing impairment of laryngeal function in parkinson's disease, alzheimer's disease, amyotrophic lateral sclerosis, laryngeal cancer, radiotherapy laryngeal * patient under guardianship * inpatient without consent * pregnant woman * patient previously treated with antibiotics for more than 24 hours at the time of icu admission * patient with infection at icu admission which justified probabilist antibiotic treatment * lack of social security * refusal of the patient or their next of kind

Keywords: aspiration pneumonia coma mechanical ventilation