Kornimate/medical-research-clean huggingface dataset:
a study of ccx140-b in subjects with primary fsgs and nephrotic syndrome

Conditions: Focal Segmental Glomerulosclerosis

Summary: an open label, intra-subject dose escalation study of ccx140 b in subjects with primary fsgs and nephrotic syndrome

an open label, intra-subject dose escalation study of ccx140 b in subjects with primary focal segmental glomerulosclerosis (fsgs) and nephrotic syndrome. the aim of this study is to explore the effect of ccx140-b, a selective antagonist of c-c chemokine receptor type 2, on proteinuria in subjects with fsgs. study acquired by amgen and all disclosures were done by previous sponsor chemocentryx.

Eligibility criteria:
inclusion criteria: 1. male or female subjects aged 18 years and older 2. primary fsgs based on renal biopsy findings consistent with fsgs and based on presentation of histopathology, medical history and clinical course or subjects with genetic risk factors with presentations that are otherwise consistent with primary fsgs 3. urinary total protein:creatinine ratio (upcr) ≥ 3.5 g protein/g creatinine at screening exclusion criteria: 1. pregnant or nursing 2. history of organ transplantation, including renal transplantation 3. currently on an organ transplant waiting list or there's a reasonable possibility of getting an organ transplant within 6 months of screening 4. histological fsgs subtype of collapsing variant 5. subjects who initiated, discontinued or changed dose of anti-cd20 monoclonal antibodies within 16 weeks (4 months) prior to screening are excluded. subjects who initiated treatment with anti-cd20 monoclonal antibodies \>16 weeks (4 months) prior to screening are permitted if deemed safe by the investigator and only if they intend to remain on continued, unchanged therapy at a dosing interval that has been documented to achieve continuous b cell depletion for the given patient. 6. subjects who discontinued rituximab or other anti-cd20 monoclonal antibodies \>16 weeks (4 months) prior to screening without confirmed recovery of cd20+ b cell population to within normal range are excluded. subjects who discontinued rituximab or other anti-cd20 monoclonal antibodies \>16 weeks (4 months) prior to screening with confirmed recovery of cd20+ b cell population to within normal range are permitted in the study. upcr and other urine protein assessments up to 1 year prior to screening (if available) that were performed in these patients as part of the clinical routine should be recorded in the medical history. 7. body mass index (bmi) ≥ 40

Keywords: fsgs glomerulosclerosis proteinuria
clinical trial of inactivated sars-cov-2 vaccine for prevention of covid-19 in healthy adults

Conditions: COVID-19

Summary: this study is an open-label phase ⅳ clinical trial of the inactivated sars-cov-2 vaccine(coronavac)manufactured by sinovac research \& development co., ltd. the purpose of this study is to evaluate the immunogenicity and safety of the inactivated sars-cov-2 vaccine (vero cell) in healthy population aged from 18 to 59 years.

this study is an open-label phase ⅳ clinical trial in healthy adult aged 18-59 years. the experimental vaccine was manufactured by sinovac research and development co.,ltd.. a total of 1400 subjects will be enrolled,the safety and immunogenicity of booster immunization were evaluated in 400 subjects (group a) who received two doses of primary immunization at an interval of 21 to 31 days. and the safety of booster immunization was evaluated in the extended safety group (group b), which included 1000 subjects.

Eligibility criteria:
inclusion criteria: * healthy adults aged 18-59; * have been received two doses of inactivated sars-cov-2 vaccine(coronavac)manufactured by sinovac research \& development co., ltd at an interval of 21 to 31 days for group a.have been vaccination two doses of inactivated sars-cov-2 vaccine(coronavac)manufactured by sinovac research \& development co., ltd for group b; * the subjects can understand and voluntarily sign the informed consent form; * proven legal identity. exclusion criteria: * history of sars-cov-2 infection; * any serious adverse reactions that are causally related to vaccination during the primary immunization of the previous inactivated sars-cov-2 vaccine; * severe allergic reactions after primary immunization (including urticaria/rash within 30 minutes after vaccination); * autoimmune disease or immunodeficiency / immunosuppression; * severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc; * severe neurological disease (epilepsy, convulsions or convulsions) or mental illness; * immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) within 6 months before primary immunization and before booster immunization; * already pregnant or are breastfeeding, planning to get pregnant (according to subjects' self-report and urine pregnancy test results) * receipt of attenuated live vaccines within 14 days prior to booster vaccination; * receipt of inactivated or subunit vaccines within 7 days prior to booster vaccination; * acute diseases or acute exacerbation of chronic diseases within 7 days prior to booster vaccination; * axillary temperature \>37.0°c prior to booster vaccination; * according to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial
safety and tolerability of omalizumab in poorly controlled moderate to severe asthma patients

Conditions: Asthma

Summary: this study will assess the safety and tolerability of long-term treatment with omalizumab plus current asthma therapy in patients who participated in and successfully completed the treatment period of study cige025ia04e1. patients who participated in cige025ia04e1 were perceived by both the patient and the investigator to have benefited from receiving treatment with omalizumab plus current asthma therapy according to best medical practice


Eligibility criteria:
inclusion criteria: * patients who completed core study and extension study cige24ia05e1 up to and including visit 15, without experiencing any significant drug-related adverse events * patients who have given written informed consent exclusion criteria: * patients who had not received study medication for greater than 84 days since visit 15 of study cige24ia05e1 * pregnant females or nursing mothers * patients with know hypersensitivity to any ingredients of omalizumab or related drugs other protocol-defined inclusion/exclusion criteria may apply.

Keywords: asthma anti immunoglobulin e omalizumab
an open label phase i study of subcutaneously administered recombinant human gm-csf in patients with aids virus infection and leukopenia

Conditions: HIV Infections; Cytopenias

Summary: to determine the safety, immunogenicity, biological activity, ad pharmacokinetics of sargramostim ( recombinant granulocyte-macrophage colony-stimulating factor; gm-csf ) human granulocyte-macrophage colony-stimulating factor ( gm-csf ), given by subcutaneous ( sc ) injection to patients with leukopenia in association with hiv infection.


Eligibility criteria:
inclusion criteria patients must have: * serum antibody to hiv with or without evidence of hiv. * antigenemia. * anticipated survival of at least 6 months. * allowed: * kaposi's sarcoma. exclusion criteria co-existing condition: patients with the following conditions or symptoms are excluded: * malignancy other than kaposi's sarcoma. * excessive diarrhea (more than 5 liquid or non-liquid stools per day). * currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infection. * primary hematologic or infectious disorders unrelated to aids virus infection. * dementia or altered mental status that would prohibit the giving and understanding of informed consent. patients with the following are excluded: * history of malignancy other than kaposi's sarcoma. * currently hospitalized or hospitalized within 4 weeks for the treatment of opportunistic infection. prior medication: excluded within 3 weeks of study entry: * marrow suppressive medication. * excluded within 4 weeks of study entry: * any investigational drug. prior treatment: excluded within 4 weeks of study entry: * systemic cytotoxic chemotherapy. * irradiation. risk behavior: excluded within 3 months of study entry: * regular, excessive users of alcohol, hallucinogens, or agents which are addicting.

Keywords: leukopenia drug evaluation granulocyte-macrophage colony-stimulating factor
management of peyronie's disease with adipose tissue stem cell

Conditions: Erectile Dysfunction; Peyronie' Disease

Summary: erectile dysfunction is growing in prevalence all over the world and one of the most existing disease in old age patients there is many lines of treatment concerning the status of patient like psychosexual, medical, and surgical treatment but pyronie's disease is common now among people especially diabetics, and the role of treatment still controversial in results we can start conservative treatment and then surgical treatment if fail but the outcome still not convinced many patients refuse to fix penile prosthesis and to make operation like nesbite for probability of shortening of penis we start to use stem cell in patients have erectile dysfunction and peyronie's disease the injection of stem cell will be at corpora cavernosa and intra dorsal penile artery under doppler device guidance

peyronie's disease associated with erectile dysfunction nan be treated by different methods we start to treat such patients with adipose tissue stem cell harvesting stem cell from adipose tissue and injected into corpora cavernosa and penile artery and we assess quality of erection through patient history and penile duplex and also assess plaque size and other symptoms related to peyronie's disease

Eligibility criteria:
inclusion criteria: * erectile dysfunction associated with peyroni's diseas exclusion criteria: * nil

Keywords: erectile dysfunction, peyronie's disease, stem cell
retrospective study to describe carfilzomib use on patients with relapsed multiple myeloma in france in the context of carfilzomib nominative expanded access and compassionate use

Conditions: Relapsed Multiple Myeloma

Summary: this retrospective multicenter observational study will provide real-life efficacy and tolerance data for patients with relapsed multiple myeloma (rmm) treated with carfilzomib in the context of nominative expanded access and compassionate use in france, and will allow to evaluate healthcare practices from data obtained during the use of carfilzomib for routine care. nominative expanded access was open in february 2014 and stopped in march 2016, then relayed by the compassionate program (march 2016- february 2017).


Eligibility criteria:
inclusion criteria: * male or female patients over the age of 18 years * patients beginning carfilzomib treatment in the framework of expanded access or compassionate use in france (krd or kd regimen) * patients who received carfilzomib in first or second mm relapse * patients receiving at least one complete course of carfilzomib exclusion criteria: * patients already included in an interventional research protocol using carfilzomib at the time of treatment initiation * patients refusing to allow the computerization of their data * patients for whom hospital medical records are not accessible

Keywords: relapsed multiple myeloma carfilzomib
impact of an e-learning coaching for parents of young children with autism

Conditions: Autism Spectrum Disorder

Summary: the goal of this study is to evaluate the impact of a parental coaching based on e-learning (el), intended for parents of children with autism spectrum disorder (asd). population: parents of young children (2 to 4 years old) with an asd diagnosis. the main questions that our study will answer are: * has parental coaching via e-learning a significant impact compared to no coaching? * if so, is that impact comparable to standard parental coaching such as pact? the impact will be evaluated in three domains: * child development: behavior, sleep, eating behavior * parental competences: stress, coping, feeling of parental competencies * parent-child interaction: communication, visual attention the investigators will compare 3 groups: 1. asd children whose parents will follow a parental coaching via e-learning, 2. asd children whose parents will follow a standard parental coaching (pact) 3. asd children whose parents will not follow any specific coaching program


Eligibility criteria:
inclusion criteria: * children with asd * age 2 years to 4 years and 6 months * family speaking french * parent who signed the consent form exclusion criteria: * children with known genetic syndrome * children with visual or auditive deficit * children with epilepsy * no internet access * no french speaking

Keywords: autism parental coaching
the study of short-range antiviral treatment during pregnancy to block mother-to-child transmission of hepatitis b virus and withdrawal time

Conditions: Chronic Hepatitis B

Summary: pregnant women carry high hbv dna loads before delivery, which is the most important factor leading to mother-to-child transmission of hbv. nucleoside analogue antiviral treatment during late pregnancy can significantly reduce the incidence of hbv mtct, but security problems of using na treatment during pregnancy has not been eliminated, therefore, the aim of our study is to explore the effect of starting to use tenofovir disoproxil fumarate(tdf) antiviral treatment from the 32 weeks of gestation to block mother-to-child transmission of hepatitis b virus(hbv mtct).

hbv mtct is the important reason to keep high prevalence of chronic hbv infection in china; high hbv dna loads of pregnant women before delivery is the most important factor resulting in mother-to-child transmission of hbv, therefore, how to drop hbv dna levels of pregnant women before delivery to the level that can markedly decrease the rate of hbv mtct on the base of hbig combined hepatitis b vaccine injection for newborns, which is the most important method to improve hbv mtct. although nucleoside analogue antiviral treatment during late pregnancy can dramatically reduce the rate of hbv mtct, security problems of na treatment during pregnancy has not been demonstrated, on account of the above problems, our study is to investigate the effect of starting to use tenofovir disoproxil fumarate(tdf) antiviral treatment from the 32 weeks of gestation to block mother-to-child transmission of hepatitis b virus(hbv mtct).

Eligibility criteria:
inclusion criteria: * pregnant women who were chronic hepatitis b and had achieved hbeag positive and hbv dna \> 106 copies/ml exclusion criteria: * active consumption of alcohol and/or drugs * co-infection with human immunodeficiency virus, hepatitis c virus, or hepatitis d virus, hiv, etc. * history of autoimmune hepatitis * psychiatric disease * evidence of neoplastic diseases of the liver * without gestational hypertension, premature rupture of membranes, antepartum haemorrhage diseases or amniotic fluid piercing history during pregnancy.

Keywords: antiviral treatment hepatitis b virus mother-to-child transmission tenofovir disoproxil fumarate
detection and characterisation of varicella zoster virus from dermal lesions of chickenpox-infected patients

Conditions: Varicella

Summary: this study is conducted in order to collect clinical samples from patients who are diagnosed of having chickenpox infection. the results of this study will provide basic scientific information about chickenpox disease.

the study involves no therapeutic or prophylactic treatment nor further observation of the patients. there is no product to be tested in this study.

Eligibility criteria:
pediatric patients who are diagnosed of having varicella and are presenting varicella dermal lesions.
influence of indoor air filtration strategies on occupant health indicators

Conditions: Risk Factors for Respiratory and Cardiovascular Disease

Summary: the purpose of this study is to evaluate whether two different central air purification technologies reduce air pollutant exposure and beneficially influence health as evaluated with a suite of biological markers related to cardiovascular and respiratory disease risk.

this study will test two common types of central air handling unit filtration technologies, high-efficiency particulate air (hepa) filters and electrostatic precipitators (esps), to evaluate the impacts of these technologies on personal exposure to air pollutants and the associated cardiovascular and respiratory health outcomes. hepa filters remove a high percentage of the particulate matter in the air, as do esps, but esps also generate ozone, which may have its own detrimental health effects. these air purification technologies will be placed in different combinations with a coarse pre-filter to protect the air exchange machinery (combinations: pre-filter only, pre-filter + hepa, and pre-filter + hepa + esp) in both the residences and offices of study participants living on a factory campus in changsha, hunan province, china. large dormitories and office buildings with central air handling units are common in china and around the world, and so adding air purification into the central ducts represents a practical strategy to reducing personal exposure to air pollution and related health outcomes. the changsha area commonly suffers from high air pollution, and the dormitories and offices on this workspace are already outfitted with both hepa filters and esps. therefore, testing these technologies in this environment presents a natural experimental condition to test the benefits of air purification. the study investigators hypothesize that both the pre-filter + hepa and pre-filter + hepa + esp conditions will reduce particulate matter exposure and reduce biological markers of cardiovascular and respiratory disease compared to the pre-filter alone, but that the esp will generate enough ozone to lead to lower health benefits than hepa+pre-filter condition.

Eligibility criteria:
inclusion criteria: * healthy adults; * live and work at the broad town work campus in eastern changsha, hunan province, china exclusion criteria: * has any of the following diseases: chronic respiratory, cardiovascular, liver, renal, hematological disease; diabetes mellitus; * has any other diseases that may confound or complicate the effects of the intervention * pregnant females

Keywords: air pollution air filtration exposure assessment hepa filter electrostatic precipitator cardiovascular disease biomarkers respiratory disease biomarkers
transfer of cardioprotection during ripc

Conditions: CABG

Summary: remote ischemic preconditioning (ripc) with transient upper limb ischemia/reperfusion provides peri-operative myocardial protection, is safe and improves prognosis in patients undergoing elective cabg surgery. the signal transfer from limb to heart is unknown. thus, the aim of this study is to identify the pathways which transfer the cardioprotective signal from the ischemic/reperfused extremity to the heart in humans undergoing surgical coronary revascularization.

the investigators will obtain arterial blood samples before skin incision and 1-72 h after the remote ischemic preconditioning protocol and analyze them biochemically. the investigators focus on those ligands that have been previously implicated in conditioning protocols at any organ. in addition, the investigators will use a bioassay system, consisting of a langendorff-perfused isolated heart with coronary occlusion/reperfusion and infarct size by ttc staining as endpoint, and then expose this bioassay system to arterial plasma obtained after the remote ischemic preconditioning stimulus or placebo. this approach will allow us to further characterize any potential transfer signal candidate with a pharmacological antagonist approach. the investigators will also obtain human atrial appendages after the remote ischemic preconditioning protocol or placebo and before patients were connected to the extracorporeal circulation. contractile function of isolated trabeculae and vasomotor function of isolated arterial vessels will be analyzed in a bioassay system.

Eligibility criteria:
inclusion criteria: * consecutive patients \> 18 years after written informed consent * elective, isolated cabg surgery with and without valvuloplastic surgery * two-stage cannulation, cardiopulmonary bypass * antegrade bretschneider cardioplegia * mild hypothermia (32°c) * preoperative standard medication (statins, betablocker, aspirin) * standard anesthesia (see above) * intraoperative standard protocol (full heparinization with act, aprotinin, protamin) * postoperative standard protocol (500 mg aspirin after 2 h, low-dose heparin after 4 h) exclusion criteria: preoperative * prior percutaneous coronary intervention (pci) within 6 weeks * any preoperative troponin t elevation * renal insufficiency (creatinine \>200 µmol/l) * reoperation * emergency surgery * acute coronary syndrome (unstable angina, stemi, nstemi) within 4 weeks * dual anti-platelet therapy (clopidogrel+aspirin) intraoperative * harvesting of a. radialis * coronary thrombendarterectomy * complications (bypass-low flow/ -occlusion) * antithrombotic therapy (intraoperative clopidogrel + aspirin) * retrograde cardioplegia
intrarater and interrater reliability physical function measures in hd bcn

Conditions: End Stage Renal Disease on Dialysis

Summary: the investigators will calculate values of absolute and relative reliability for intrarater reliability when the measures are taken during a hemodialysis treatment day and during a non-dialysis day. interrater reliability between two different observers will be also calculated

patients suffering from end stage renal disease are commonly involved in haemodialysis treatment, which is the most common treatment at this stage. haemodialysis substitutes the renal function but is associated with several alterations that lead to decrease in functional capacity. many studies show that functional capacity is significantly worse than their healthy sedentary age - matched counterparts. the purpose of the present study is to calculate values of absolute and relative intrarater reliability (dialysis vs non dialysis day) and interrater reliability of different physical function measures (short physical performance battery, one-leg balance, timed up and go, sit to stand to sit tests, triceps and handgrip strength, six-minute walking test).

Eligibility criteria:
inclusion criteria: * at least 3 months in hemodialysis treatment * clinically stable exclusion criteria: * recent cardiac events (less than 3 months) * unable to exercise