Kornimate/medical-research-clean huggingface dataset:
ra-4: 13-cis retinoic acid for treatment of men with azoospermia

Conditions: Male Infertility, Azoospermia

Summary: men with infertility and normal hormone levels have few options for fertility treatment. previous research suggests that men with infertility may have low levels of the active form of vitamin a, called retinoic acid, in their testes. in a pilot study of 20 men with low numbers of sperm (\<10 million motile sperm), roughly half the men showed improvement in sperm production. thus, we want to see if retinoic acid administration to men with azoospermia (no sperm present) can initiate sperm production.

twenty men with infertility, aged 21 - 60, due to azoospermia (no apparent sperm in the ejaculate on two separate occasions) will be enrolled in a single-arm pilot trial of daily oral therapy of 20 mg twice daily of 13-cis retinoic acid for 32 weeks. the impact of treatment on the appearance of sperm in the ejaculate will be determined by monthly semen analyses. note: the outcome measure of serum and seminal plasma 13-cis-retinoic acid concentrations was entered in error and not intended to be reported for this study. information on these levels is available in our earlier study of 13-cis-retinoic acid in men with sub-fertility. amory et al. andrology 2017 5:1115-1123.

Eligibility criteria:
inclusion criteria: infertile men with azoospermia on at least two semen analyses separated by at least one week, and no pregnancy with partner with normal cycles and normal hysterosalpingogram despite \>1 year of unprotected intercourse. - exclusion criteria: hypogonadotropic hypogonadism (that might respond to gonadotropin injections); use of anabolic steroids,illicit drugs, or consumption of more than 4 alcoholic beverages daily; current therapy with retinoic acid (eg accutane) or vitamin a- of use of isotretinoin within eight weeks of start of dosing;phenytoin, or medication containing tetracycline; personal history of serious psychiatric disorders, score of greater than 15 on the phq9 (mood) questionnaire; elevated serum serum triglycerides or other abnormal serum chemistry values; history of inflammatory bowel disease or bone disease; not living within catchment area; participation in another clinical trial -

Keywords: infertility
inferior vena cava and lung ultrasound-guided therapy in acute heart failure

Conditions: Heart Failure; Acute Heart Failure

Summary: between 25% and 30% of patients hospitalized for acute heart failure (ahf) are readmitted within 90 days after discharge. mostly due to persistent congestion on discharge. however, as the optimal evaluation of decongestion is not clearly defined, it is necessary to implement new tools to identify subclinical congestion to guide treatment.


Eligibility criteria:
inclusion criteria: - hospitalization of 24 hours or greater for decompensated heart failure defined as new-onset of symptoms or worsening of previous symptoms (including orthopnea, progression to fc iii-iv, bendopnea or fatigue) or signs of volume overload. and - jugular venous distension, hepatojugular reflux, lower extremity edema or signs of pulmonary congestion. and * chest x-ray with signs suggestive of pulmonary congestion. and * elevated ´pro-b-type natriuretic peptide (nt-probnp) levels of 450 pg/ml, 900 pg/ml, and 1800 pg/ml for ages \ 75 years, respectively, within 24 hours of admission (53,54). and - sufficient ultrasound visualization to assess ivc and lungs. exclusion criteria: * not willing to participate. * life expectancy of less than 6 months. * uninterpretable lung or inferior vena cava ultrasound. * transfer to another hospital before hospital discharge. * sbp \< 90 mm hg. * chronic kidney disease (creatinine clearance \<30 ml/min calculated with the mdrd equation or hemodialysis). * requirement for invasive or noninvasive ventilator support. * pregnancy. * low cardiac output syndrome/cardiogenic shock. * death during index hospitalization. * acute coronary syndrome, myocardial revascularization or heart valve replacement within the previous 3 months. * being on heart transplant waiting list. * cardiac resynchronization therapy device implanted within the previous 3 months. * severe tricuspid valve regurgitation. * heart failure secondary to causes amenable to invasive correction: cardiac surgery, percutaneous interventions or pacemaker implantation. * heart failure secondary to significant arrhythmias (advanced atrioventricular block or sinus arrest, sustained ventricular tachycardia or any sustained arrhythmia other than atrial fibrillation causing hemodynamic instability according to the discretion of the treating physician). * heart failure secondary to severe systemic infection * severe psychiatric illness * palliative care * sars-cov-2 infection
dual target car-t cells in b-cell acute lymphoblastic leukemia

Conditions: Dual-target CAR-T Cells; B ALL; Relapse; Refractory B Acute Lymphoblastic Leukemia

Summary: prospectively evaluate the safety and effectiveness of cd19/cd22 dual-target car-t cells in the treatment of relapsed/refractory b-cell acute lymphoblastic leukemia.

prospectively evaluate the safety and effectiveness of cd19/cd22 dual-target car-t cells in the treatment of relapsed/refractory b-cell acute lymphoblastic leukemia. strictly follow the inclusion criteria to screen eligible subjects for inclusion in clinical trials. the selected patients received cd19/cd22 dual-target car-t cell therapy. after the treatment is over, follow-up regularly to determine the survival status and follow-up treatment.

Eligibility criteria:
inclusion criteria: * subjects must meet the following criteria to participate in this study: 1. 14-75 years old, no gender limit; 2. according to the 2020 world health organization (who) diagnostic criteria, it is diagnosed as relapsed/refractory b-cell acute lymphoblastic leukemia (r/r b-all); 3. ecog behavior status score is 0-2 points; 4. expected survival time ≥ 3 months; 5. no contraindications to peripheral apheresis; 6. flow cytometry confirms that the original cells express cd22; 7. those who are tolerant to cd19 car-t cell therapy or those with low cd19 expression; 8. no serious heart, lung, liver or kidney disease; 9. ability to understand and willing to sign the informed consent form for this trial. exclusion criteria: * patients with any of the following cannot be included in this study: 1. the original cells expressing cd19 and cd22 are negative; 2. there is active infection; 3. abnormal liver function ( glutamic-pyruvic transaminase\>1.5×uln, glutamic oxalacetic transaminase\>2.5×uln), abnormal renal function (serum creatinine\>1.5×uln); 4. people with unstable angina or new york heart association class 3/4 congestive heart failure, multiple organ dysfunction; 5. hiv/aids patients; 6. those who need long-term anticoagulation (warfarin or heparin), antiplatelet (aspirin, dose\>300mg/d; clopidogrel, dose\>75mg/d) treatment; 7. those who received radiotherapy within 4 weeks before the start of the study (blood sampling); 8. known or suspected drug abuse or alcohol dependence; 9. people with mental illness or other conditions cannot obtain informed consent, and cannot cooperate with the requirements for completing the experimental treatment and inspection procedures; 10. those who have participated in other clinical trials within 30 days; 11. pregnant or lactating women, male subjects (or their partners) or female subjects have a pregnancy plan during the study period to 6 months after the end of the test, and are unwilling to use a medically approved effective contraceptive measure during the test period (such as intrauterine device or condom); 12. the investigator judged that it is not suitable to participate in this trial.
safety, tolerability, pharmacokinetics and pharmacodynamics of oral insulin (in-105) in type 1 diabetes patients

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of this study is to see whether in-105 (oral insulin) is able to control increase in blood glucose after eating a meal. this study will also tell whether single tablet of in-105 is safe for patients with type 1 diabetes mellitus who are currently taking insulin injections.


Eligibility criteria:
inclusion criteria: 1. male and female patients between the ages of 18-45 years inclusive 2. established diagnosis of t1dm for at least 1-year 3. body mass index of 18.5-29.9 kg/m2 inclusive 4. stable weight with no more than 5 kg gain or loss within 3 months of screening 5. hba1c ≤ 8.0% 6. on stable insulin or an insulin analogue regimen for at least 3 months exclusion criteria: 1. any hypersensitivity or allergy 2. positive urine ketones test at screening visit. 3. ecg abnormality 4. total daily insulin \>1 iu/kg and/or \>0.7 iu/kg of basal insulin and/or \>0.6 iu/kg of prandial insulin. 5. patient with a clinically significant abnormality 6. evidence of severe secondary complications of diabetes 7. history of drug or alcohol dependence or abuse 8. patients currently on systemic or inhaled glucocorticoids or other drugs, which may affect glycemic control. 9. patients treated with blood-glucose lowering drugs other than insulin or insulin analogues in the last 4 weeks prior to screening or during the study 10. history of two or more severe episodes of hypoglycemia (defined by ada criteria) within 6 months prior to screening and/or patients with history of low blood glucose level episodes suggestive of hypoglycemia unawareness (loss of warning symptoms of hypoglycemia). investigator to assess this criterion based on the subject filled questionnaire. 11. any hospitalization or emergency room visit due to poor diabetes control within 6 months prior to screening. 12. impaired hepatic function (alt or ast value greater than 2 x upper limit of reference range and/or serum bilirubin ≥1.5 x upper limit of reference range at the screening visit). 13. impaired renal function (serum creatinine ≥1.5 x upper limit of reference range at screening). 14. hemoglobinopathies, haemolytic anaemia, anaemia of chronic disease, or any factor affecting the measurement of hba1c. 15. any electively planned surgery requiring hospitalization during the study period. 16. pregnancy, lactation, or planned pregnancy during the study duration. 17. the patient has received another investigational drug within 6 weeks prior to screening 18. mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
proton therapy to reduce acute normal tissue toxicity in locally advanced non-small-cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: the aims of the study are to reduce acute radiation induced side effects, i.e. pneumonitis and esophagitis grade ii or higher by the use of proton therapy compared to photon radiotherapy of equal total dose. secondary endpoints include evaluation of quality of life, loco-regional control, survival and late radiation induced side effects.

patients in this trial undergo primary radiochemotherapy for locally advanced nsclc. as early and intermediate late effects of radiotherapy do not only hamper quality of life but can, in the case of radiation induced pneumonitis, be potentially lethal, a reduction of these side effects is desirable. patients in this trial are 1:1 randomised to intensity modulated radiotherapy with photons or proton therapy. the primary aim of the study is to show a decrease of pneumonitis and or esophagitis grade 2 or higher by proton therapy. the observed incidence of both these side effects is 39% with photon therapy. the estimated incidence with proton therapy is around 12 %. simultaneous chemotherapy will be applied to current clinical standards.

Eligibility criteria:
inclusion criteria: * nsclc (confirmed by cytology or histology) staged uicc iiia or iiib or uicc ii if the patient declines surgery * no distant metastases (m1) * patient' age between 18 and 70 years * patient medically suited for primary radiochemotherapy with curative intent * signed declaration of informed consent * adequate compliance for treatment and clinical follow up * adequate contraception during and after therapy if indicated exclusion criteria: * participation in other interventional trial * t1 or t2 n0 tumours that are candidates for stereotactic radiotherapy * relevant neurological or psychiatric disorders that hinder treatment, follow-up or understanding of the procedures * pregnant or breastfeeding women * prior thoracic radiotherapy * history of other malignancies during the last 5 years (exceptions can be made for tumours with excellent outcome) * weight loss greater than 15% before therapy * serological alterations (liver, kidney) prohibiting application of simultaneous chemotherapy * respiratory motion of the tumour \> 10 mm (evaluated by 4d ct), also when methods for motion reduction (abdominal compression) are used
efficacy & safety of tenofovir disoproxil fumarate (tdf) plus peginterferon α-2a (peg-ifn) versus tdf or peg-ifn monotherapy in chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: the primary objective of this study is to evaluate the efficacy of tenofovir disoproxil fumarate (tdf) plus peginterferon α-2a (peg-ifn) combination therapy for 48 weeks versus standard of care tdf monotherapy or peg-ifn monotherapy for 48 weeks in non-cirrhotic adults with chronic hepatitis b virus (hbv) as determined by loss of hepatitis b surface antigen (hbsag). the study will consist of 2 phases for participants in the tdf+peg-ifn 48 weeks, tdf 48 weeks + peg-ifn 16 weeks, and peg-ifn 48 weeks groups. following an initial 48 weeks of treatment, participants in these groups will be monitored for 24 weeks for signs of worsening hbv, and those meeting tdf retreatment and flare management criteria will be eligible to receive tdf monotherapy during a retreatment phase, up to week 120.


Eligibility criteria:
inclusion criteria: * adults (age 18-75) with chronic hbv (positive for serum hepatitis b surface antigen (hbsag) or hbv dna for at least 6 months) prior to baseline * anti-hbv treatment-naive adults; adults who have taken oral anti-hbv nucleoside therapy with the last dose ≥ 24 weeks prior to screening are also eligible. * positive or negative for hepatitis b e antigen (hbeag) * hbv dna ≥ 20,000 iu/ml (hbeag-positive participants) and ≥ 2,000 iu/ml (hbeag-negative participants) * alanine aminotransferase (alt) \> 54 u/l and ≤ 400 u/l for men and \> 36 u/l and ≤ 300 u/l for women * creatinine clearance ≥ 70 ml/min * negative serum pregnancy test for females of childbearing potential * sexually active females of childbearing potential must agree to use a protocol-recommended method of contraception throughout the study and for 30 days following the last dose of study medication * lactating females must agree to discontinue nursing before initiation of study investigational medicinal product exclusion criteria: * known bridging fibrosis or cirrhosis and/or decompensated liver disease * evidence of hepatocellular carcinoma * significant kidney, heart, lung, neurological, autoimmune disease, or bone disease (eg, osteomalacia,chronic osteomyelitis, osteogenesis imperfecta, osteochondrosis, multiple bone fractures) * absolute neutrophil count \< 1,500/mm\^3, platelet \< 100,000/mm\^3, hemoglobin \< 10 g/dl (female) or \< 11 g/dl (male) * history of severe depression or severe psychiatric disease * thyroid dysfunction * coinfection with hiv, hepatitis c virus (hcv) or hepatitis d virus (hdv) * pregnant

Keywords: chronic hepatitis b hep b non cirrhotic tenofovir disoproxil fumarate (tdf) peginterferon α-2a (peg-ifn)
primary vaccination course in children receiving the pneumococcal vaccine gsk 1024850a, zilbrix™ hib and polio sabin™

Conditions: Infections, Streptococcal

Summary: the purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of african sub-saharan infants with pneumococcal conjugate vaccine gsk 1024850a co-administered with a diphtheria, tetanus, whole cell pertussis (dtpw)-combined vaccine and oral polio vaccine in children during the first 4 months of life.

vaccination course at 6, 10, 14 weeks of age.

Eligibility criteria:
inclusion criteria: * male or female subjects between, and including 6-10 weeks of age at the time of the first vaccination. * subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study. * written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness. * free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study), that would contraindicate the initiation of routine immunizations outside a clinical trial context. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * chronic administration of immunosuppressants or other immune-modifying drugs since birth. * a family history of congenital or hereditary immunodeficiency. * any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (hepatitis b immunoglobulins at birth are allowed). * previous vaccination against, diphtheria, tetanus, pertussis, haemophilus influenzae type b and/or streptococcus pneumoniae. * history of, or intercurrent diphtheria, tetanus, pertussis, hepatitis b, streptococcus and haemophilus influenzae type b disease. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * history of any neurological disorders or seizures. * major congenital defects or serious chronic illness. * acute disease at the time of enrolment. study entry should be delayed until the illness has improved. * babies for which birth weight is \< 2 kilogram (if known) at visit 1

Keywords: pneumococcal conjugate vaccine streptococcus pneumoniae
a cross-sectional study to assess walking performance in subjects with peripheral artery and end stage kidney disease

Conditions: Peripheral Artery Disease; End Stage Renal Disease on Dialysis

Summary: a cross-sectional, non-interventional study to assess walking performance, vascular function, and lower limb calcification in subjects with peripheral artery disease and end-stage kidney disease (pad-eskd) receiving hemodialysis.


Eligibility criteria:
inclusion criteria: * ≥55 years of age or ≥45 years of age with diabetes * receiving maintenance hd in a clinical setting for at least 2 weeks prior to screening * resting abi \<0.90 in either leg or resting tbi \<0.70 in either leg * symptomatic as characterized by a limitation in exercise performance exclusion criteria: * above-ankle amputation * chronic limb-threatening ischemia (rutherford 4-6) * non-ambulatory status * a condition other than pad that limits ability to walk * open or endovascular revascularization within 3 months prior to baseline. * illnesses, conditions, or planned surgeries within the study period that will interfere with the interpretation of the study results

Keywords: pad peripheral artery disease end stage kidney disease end stage renal disease dialysis
correlation of carotid flow time and cardiac output.

Conditions: Volume Responsiveness

Summary: assessment of common carotid artery flow is more easily done and can be taught more broadly than transthoracic echocardiography, providing a greater number of clinicians a tool to assess volume responsiveness. these assessments are of great importance to patients with covid-19, who often present with hypotension requiring fluids, which must be balanced against limiting fluid administration to minimize pulmonary edema.

optimizing volume status for patients in shock is of critical importance to their outcomes, both in the provision of helpful, and avoidance of harmful fluid volumes. as such, much work has been done to develop and assess measures of volume responsiveness; that is, tests that indicate whether additional fluid administration will increase cardiac output by at least 10%. the passive leg raise (plr) providing a reversible "auto-bolus" has been demonstrated to be the most predictive assessment of fluid responsiveness. recent studies of changes in carotid artery blood flow suggest it can be used as a surrogate for changes in cardiac output with moderate reliability. this has been assessed in several populations with anticipated changes in volume status (e.g. before/after blood donation), and more recently assessed by sidor et al. against several preload augmenting maneuvers. interestingly, while decreasing preload resulted in a decrease in cardiac output and systolic carotid blood flow, it did not result in a decrease in corrected carotid flow time, although a plr produced an expected increase in all measures. in our study we seek to validate these results, questioning if there is a lower limit of corrected carotid flow time that de-couples the relationship between carotid systolic flow and corrected carotid flow time.

Eligibility criteria:
inclusion criteria: * adult patient admitted to hospital with diagnosed covid-19, on up to 6l oxygen, and able to undergo leg compression testing and passive leg raise. exclusion criteria: * known cardiac disease, carotid atherosclerosis, prior right-sided neck surgery, chest wall deformity, or deep-venous thrombosis identified on admission

Keywords: volume responsiveness, ultrasound, fluid responsiveness
remote ischemic conditioning in necrotizing enterocolitis

Conditions: Enterocolitis, Necrotizing

Summary: necrotizing enterocolitis (nec) affects up to 10% of very preterm infants. nec mortality is high (30-50 %) and has remained unchanged over the last decades. new treatments are urgently needed. nec pathogenesis is multifactorial, but bowel ischemia plays an essential role in nec development. remote ischemic conditioning (ric) consists in inducing brief periods of non-lethal ischemia in a limb distant to an organ suffering from ischemia. ric has been used in adults, children and term neonates with a variety of diagnosis. however, no study has been done including preterm infants with nec.

an appropriately sized blood pressure cuff will be applied to an arm or leg and inflated to promote ric. this study will be conducted in three phases to assess the feasibility and safety of ric in relation to duration of ischemia time, number of cycles of ric and whether it is feasible and safe to perform ric on consecutive days.

Eligibility criteria:
inclusion criteria: * patients with nec (stages i-iii bell's classification) * weight greater or equal to 750 g. * gestational age \< 36 weeks. * patients whose parents consent to participate in the study. exclusion criteria: * patients with major congenital anomalies * no antecedent of limb ischemia/limb thrombotic events. * no antecedent diagnosis of occlusive arterial or venous thrombosis * hemodynamic instability