Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety and pharmacokinetics of ataluren in participants from ≥6 months to <2 years of age with nonsense mutation duchenne muscular dystrophy (nmdmd)

Conditions: Nonsene Mutation Duchenne Muscular Dystrophy

Summary: this study is designed to evaluate safety, tolerability, and pharmacokinetics (pk) in male children with nmdmd aged ≥6 months to \<2 years treated daily for 24 weeks with orally administered ataluren 10, 10, and 20 milligrams/kilogram (mg/kg) (morning, mid-day, and evening dose, respectively).

participants who complete the 24-week treatment period in this study will be offered participation to a follow-up extension period for at least 52 weeks from the date of first administration of ataluren in this parent study.

Eligibility criteria:
inclusion criteria: * body weight ≥7.5 kilograms (kg) * diagnosis of duchenne muscular dystrophy (dmd) based on an elevated serum creatine kinase and genotypic evidence of dystrophinopathy. * documentation of the presence of a nonsense mutation of the dystrophin gene as determined by gene sequencing prior to enrollment. exclusion criteria: * participation in any drug or device investigation or whose sibling is currently participating in a blinded portion of another ataluren study or received an investigational drug within three months prior to the screening visit or who anticipate participating in any other drug or device clinical investigation or receiving any other investigational drug within the duration of this study. * expectation of a major surgical procedure during the study period. * known hypersensitivity to any of the ingredients or excipients of the study drug (polydextrose, polyethylene glycol 3350, poloxamer 407, mannitol 25c, crospovidone xl10, hydroxyethyl cellulose, vanilla, colloidal silica, or magnesium stearate). * ongoing use of the following drugs: 1. systemic aminoglycoside therapy and/or intravenous (iv) vancomycin. 2. coumarin-based anticoagulants (for example, warfarin), phenytoin, tolbutamide, or paclitaxel. 3. inducers of ugt1a9 (for example, rifampicin), or substrates of oat1 or oat3 (for example, ciprofloxacin, adefovir, oseltamivir, aciclovir, captopril, furosemide, bumetanide, valsartan, pravastatin, rosuvastatin, atorvastatin, pitavastatin).
lower limb venous insufficiency and the effect of radiofrequency treatment versus open surgery

Conditions: Varicose Veins; Venous Insufficiency

Summary: 200 patients with insufficient great saphenous veins will be randomized to either radiofrequency ablation or high ligation/stripping (open surgery). they will be examined according to standardized examination protocol venous clinical severity score (vcss), with duplex ultrasound and plethysmography pre- and postoperatively (1-month, 1-, 3 and 5 years). they are to fill questionnaires euroqol 5 dimensions (eq-5d) and disease specific aberdeen varicose vein questionnaire (avvq).


Eligibility criteria:
inclusion criteria: * insufficient great saphenous vein * possible to treat with both radiofrequency ablation and high ligation/stripping * clinical etiological anatomical pathophysiological score (ceap) c2-c6 exclusion criteria: * previous intervention in the affected leg * insufficient accessory branch origin close to the great saphenous vein estuary in the femoral vein. * small saphenous vein insufficiency with diameter \>6 mm and/or flow \>100ml/min * patient that is not able to perform plethysmography

Keywords: radiofrequency ablation plethysmography duplex ultrasound high ligation/stripping
combined illness management and psychotherapy in treating depressed elders

Conditions: Depression; Heart Failure; Chronic Obstructive Pulmonary Disease

Summary: the purpose of this research study is to test a program developed to help patients with chronic heart or lung problems take care of themselves and cope with their illness or limitations.


Eligibility criteria:
inclusion criteria: * age 55 years or older * diagnosis of heart failure or copd * depressive symptoms indicated by a bdi-ii score of 10 or higher * functional impairment exclusion criteria: * current psychotherapy * cognitive impairment * psychiatric diagnosis * active suicidal thoughts * significant vision or hearing impairment * residence in long term care facility

Keywords: depression heart failure chronic obstructive pulmonary disease quality of life functional impairment
inhaled technosphere insulin in subjects with diabetes mellitus and asthma

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Asthma

Summary: the clinical trial is designed to evaluate the safety of inhaled technosphere/insulin compared with non-inhaled anti-diabetic therapies in subjects with type 1 or type 2 diabetes mellitus and concurrent asthma.


Eligibility criteria:
inclusion criteria: * a clinical diagnosis of step 1 to 3 asthma as per the naepp guidelines * clinical diagnosis of type 1 or type 2 diabetes mellitus for at least 1 year * current stable anti-diabetic regimen (insulin alone or in combination with oral anti-hyperglycemic agents) * subjects must exhibit \<30% variability in pef measurements during the 2 week run in period. * subjects must not meet any criteria for exacerbations of asthma during the 2 week run in period * body mass index (bmi) \< 40kg/m2 * hba1c \>6.0% to \<11.5% exclusion criteria: * severe complications of diabetes in the opinion of the investigator * seizure disorder * significant cardiovascular dysfunction and/or history within 3 months of screening * hypertension with systolic blood pressure of !80 mm hg and/or diastolic blood pressure \>110 mm hg at screening despite pharmacologic therapy. * clinical nephrotic syndrome or renal dysfunction or disease * total daily insulin requirement of \>1.4 u/kg body weight * clinical diagnosis of step 4 asthma * use of \>6 puffs/day of fast acting bronchodilator * currently using an insulin delivery pump * use of pramlintide acetate or any incretins must be discontinued 8 weeks prior to screening * two or more severe hypoglycemic episodes within the past 6 months. * any hospitalization or emergency room visit due to poor diabetic control with 6 months of screening. * current use of systemic steroids * subjects who currently smoke tobacco or who have smoked within the past 6 months * urine cotinine test of \> 100ng/ml * current drug or alcohol abuse * clinically significant abnormalities on screening laboratory evaluation * cancer within the past 5 years or any history of lung neoplasms * history of active and/or cirrhotic hepatic disease and/or abnormal liver enzymes. * active infection or history of severe infection with 30 days of screening. * anemia * history of anaphylaxis and/or angioneurotic edema * diagnosis of chronic obstructive pulmonary disease (cope) * previous exposure to any inhaled insulin product

Keywords: inhaled insulin diabetes type i and ii with asthma
functional and sexual outcomes after laparoscopic ventral mesh rectopexy for complex rectocele

Conditions: Rectocele; Obstructive Defecation Syndrome

Summary: the ideal surgical strategy for treating complex rectocele remains a topic for debate, with the transanal, transperineal, and transvaginal approach and the abdominal approach being at conflict with one another. while the transvaginal repair is more popular among gynecologists, the trans abdominal approach has become increasingly common among colorectal surgeons, in part due to the rising demand for minimally invasive surgery.

for the treatment of rectoceles and ods in general, the laparoscopic method has recently come to light as a promising alternative. laparoscopic ventral mesh rectopexy (lvmr) was originally described for the management of rectal prolapse. however, it was also recommended with encouraging results for the treatment of large symptomatic rectocele. the present study aims to evaluate the safety and efficacy of lvmr for complex rectocele.

Eligibility criteria:
inclusion criteria: * multiparous female patients. * aged between 30 and 60 years * who were diagnosed with complex anterior rectocele- more than 3cm after failed medical treatment- with history of either vaginal delivery or caesarian section. * complex rectocele was one having any of the following features: size \> 3 cm in diameter, associated enterocoele or internal rectal prolapse exclusion criteria: * paradoxical contraction of puborectalis muscle (anismus), * complete external rectal prolapse * fecal incontinence * other benign anal conditions * those who are unfit for surgery due to associated severe co-morbidities

Keywords: anterior rectocele laparoscopic ventral mesh rectopexy
role of mdscs and cancer stem cells and their cross talks in nsclc

Conditions: Lung Neoplasms; Myeloid-Derived Suppressor Cells; Immunosuppression

Summary: immunotherapy have revolutionized the field of oncology, but response rates are low and all patients relapse, due to cellular and soluble immunosuppressive mechanisms. mdsc are one of the most important immunosuppressive cells, that also harbour non immunologic functions, favouring cancer invasion. these non immunologic functions of mdsc in lung cancer will be better characterized. indeed, cellular mechanisms will be analysed by in vitro studies, assessing the effect of immunosuppressive cells, provided by fresh tumor samples, on phenotype and functions of lung cancer cell lines. the aim of this study is to better characterize immunosuppressive landscape of nsclc and mechanisms involved in their protumor functions.

in recent years, immune-based therapies have revolutionized the field of oncology by significantly improving survival of cancer patients. despite sustained responses, only 20% to 40% of cancer patients respond. it has become clear that the immunosuppressive environment induced by tumor through cellular and/or soluble pathways critically contribute to hinder efficient antitumor immunity. the inhibition of these immunosuppressive networks thus represents an essential prerequisite for the improvement of responses to anticancer immunotherapies. several immune cell populations have been identified as key actors of tumor-induced immunosuppression, among which are myeloid-derived suppressor cells (mdsc) and regulatory t lymphocytes (treg). however, in non-small cell lung cancers (nsclc), the prognostic role of these cells, the mechanisms underlying their immunosuppressive functions, their "non-immunological" protumoral functions and their role in dampening the efficacy of immunotherapies in clinical practice are less characterized. the aim of this project is to better characterize the non immunologic functions of mdsc. we propose to assess in vitro the non-immunological pro-tumor functions of mdsc isolated from lung cancer patients

Eligibility criteria:
inclusion criteria: * consecutive patients * lung carcinoma surgically treated by surgery only exclusion criteria: * patient receiving chemotherapy, radiotherapy or immunotherapy in the neoadjuvant setting (all objectives) * patient with concomitant or previous cancer (in the 2 years)

Keywords: lung cancer immunosuppression immuno-oncology antitumor immune escape invasion
comparison of the efficacy of granulocyte-macrophage colony stimulating factor (gm-csf) and norfloxacin in secondary prophylaxis for spontaneous bacterial peritonitis

Conditions: Spontaneous Bacterial Peritonitis

Summary: -consecutive patients of decompensated cirrhosis of any etiology, presenting to the institute of liver and biliary sciences hospital with spontaneous bacterial peritonitis will be evaluated


Eligibility criteria:
inclusion criteria: * age 18 - 70years * patients of decompensated liver cirrhosis who present with spontaneous bacterial peritonitis (presence of more than 250 neutrophils per cc of ascitic fluid, in the absence of a surgical abdomen, in the presence of decompensated cirrhosis and portal hypertension) that has responded to standard medical care. exclusion criteria: * allergic to quinolones * advanced hcc (hepatocellular carcinoma) * post liver transplant * hiv (human immunodeficiency virus) positive patients * patients on immunosuppressive therapy * pregnancy * acute liver failure * history of hematological malignancy or bone marrow transplantation * no informed consent
adamtsl4 in idiopathic pulmonary hypertension and cteph

Conditions: Pulmonary Hypertension

Summary: adamtsl4 (a disintegrin and metalloproteinase with thrombospondin motifs like) is a member of the adamtsl family. adamtsl4 is one of the family of 7 adamts-like proteins, themselves part of the thrombospondin type 1 repeat (tsr) superfamily of proteins. these 7 proteins are divided into two distinct clades, of which adamtsl4 and adamts-like 6 form part of one clade, differing from adamts-like 1, adamts-like 3 and adamts-like 7 by lacking immunoglobulin repeat regions. adamtsl4 is widely expressed in brain, colon, heart, kidney, liver, lung, pancreas and spleen, yet, its precise role is unclear. in addition, adamtsl4 protein high expression to the medial layer of the arterial wall, and medial vascular smooth muscle cells specifically.

the objectives of the present study aimed to confirm adamtsl4 levels in the proteomics between healthy control population and patients with ipah，to analyze the expression levels of adamtsl4 between patients with ipah and cteph, and to investigate whether serum levels of adamtsl4 might be used as biomarkers of disease severity in these patient populations.

Eligibility criteria:
inclusion criteria: - healthy people，patients with ipah，patients with cteph exclusion criteria: - tumour，infection，pregnancy, suckling period， mental disorders， other types of pah except cteph and ipah
naïve hiv poc monotherapy trial

Conditions: HIV Infections

Summary: the primary objective of the trial is: • to evaluate the change from baseline in plasma viral load with placebo and one of up to 4 dose regimens of rdea806. the secondary objectives are: efficacy * to describe the nadir of the plasma viral load * to describe the davg * to assess the proportion of subjects who reached a drop in viral load of 0.5 log, 1 log, or reach an undetectable viral load * to assess the plasma viral load decay rate * to evaluate immunologic changes (as measured by cd4 and cd8 cells) * to evaluate the genotypic and phenotypic pattern of the virus pharmacokinetics * to evaluate the pharmacokinetics and the pharmacokinetic/pharmacodynamic relationship of rdea806 safety * to evaluate the safety and tolerability of bid and qd dosing of rdea806 as monotherapy


Eligibility criteria:
inclusion criteria: * documented chronic hiv-1 infection * hiv-1 plasma viral load at screening visit above 5000 hiv-1 rna copies/ml * male, aged above 18 years and less than 65 years of age * adequate method of birth control * subject has never received an antiretroviral agent (nrti, nnrti, pi, entry inhibitor or integrase inhibitor) for the treatment of hiv and agrees not to start antiretroviral therapy prior to enrollment or subject has only received a short course of treatment for less than 14 days and has been off treatment for at least 8 weeks * subject has no primary mutation in the reverse transcriptase (rt) gene associated with resistance to rt inhibitors and no major mutation in the protease gene associated with resistance to pis determined by genotypic resistance testing at screening exclusion criteria: * history or suspicion of alcohol or drug abuse which in the investigator's opinion may lead to non-compliance * cd4 count \< 350 cells/mm3 * life expectancy of less than 6 months * receipt of an investigational drug within 30 days prior to the trial drug administration * receipt of any vaccine within 30 days of screening visit * acute hiv-1 infection (seroconversion illness) * acute hepatitis a or acute or chronic hepatitis b or c infection * currently active acquired immune deficiency syndrome (aids)-defining illness (category c conditions according to the centers for disease control \[cdc\] classification system for hiv infection 1993) * no clinically relevant laboratory abnormalities renal impairment: serum creatinine \> 1.5 x uln * febrile illness within 120 hours prior to dosing * history of severe drug allergy or hypersensitivity * significant cardiac dysfunction

Keywords: hiv treatment naïve
pelvic floor symptoms and quality of life in elderly women - a population-based pilot study

Conditions: Urinary Incontinence; Quality of Life

Summary: to assess pelvic floor symptoms and quality of life in elderly women.

the aim is to assess pelvic floor symptoms and quality of life in elderly women. the study is conducted as population-based in 100-130 women at the age of 64-66 years. all study objects are examined gynecologically and with vaginal ultrasound. subjective symptoms are evaluated with validated questionnaires concerning pelvic floor symptoms, sexual symptoms and quality of life. this is a pilot study before a larger scale population-based study.

Eligibility criteria:
inclusion criteria: * all women in one municipality aged 64-66 years who are willing to participate in the study. exclusion criteria: * persons under guardianship or who does not understand the used questionnaires.

Keywords: urinary incontinence pelvic floor quality of life elderly women
comparing the efficacy of the alcohol help centre and check your drinking to a no intervention control condition

Conditions: Alcohol Consumption

Summary: alcohol is one of the leading contributors to premature mortality and disability. most people with alcohol problems will never seek treatment. there is a need to develop alternate ways to help problem drinkers outside of formal treatment settings. one promising strategy is internet-based interventions for problem drinkers. our recently completed rct comparing a brief (check your drinking; cyd) versus an extended (alcohol help centre; ahc) internet intervention for problem drinkers found that, while there was a reduction in drinking across time for both interventions, there was no significant (p \> .05) difference in reductions in drinking between the two interventions. based on these results, it is not justifiable to say that either intervention 'worked' as there was no comparison condition of participants who received no active intervention. the current trial proposes to address this limitation by conducting an rct comparing the cyd, ahc, and a no intervention control condition. participants will be recruited through amazon's mturk crowdsourcing platform. participants identified as problem drinkers based on an initial survey will be invited to complete another survey in 6 months time. those who are interested will be randomized to receive access to the check your drinking screener (cyd condition), alcohol help centre (ahc condition) or a feedback questionnaire (control condition). at six-months post-baseline, the mturk portal will be used to send invitation emails that contain a link to the follow-up survey. the primary hypothesis to be tested is that participants receiving access to the ahc intervention will report a greater reduction in audit-c scores and in number of drinks in a typical week than participants in the cyd intervention. further, participants in the cyd condition will report a greater level of reduction audit-c scores and in number of drinks in a typical week between the baseline survey and six-month follow-up as compared to participants in the no intervention control condition.


Eligibility criteria:
inclusion criteria: * 18 years of age or over * a score of 8 or over on the alcohol use disorders identification test (audit) * typically consumes 15 or more drinks per week, * willingness to complete a 6-month follow-up survey exclusion criteria:none -
safety and immunogenicity of covi-vac as a booster dose in adults previously vaccinated against covid-19

Conditions: COVID-19; SARS-CoV-2

Summary: the purpose of this study is to to evaluate the safety and immune response of covi-vac given as a single booster dose in healthy adults previously vaccinated against covid-19 with an authorised mrna or adenovirus-vectored vaccine. approximately 30 participants who have been fully vaccinated ≥ 3 months ago will be enrolled and receive one dose of covi-vac. covi-vac is administered by drops into each nostril. to assess the safety of the vaccine, each participant will record symptoms and oral temperature in a diary daily for 7 days after receiving covi-vac or placebo. during the full study safety laboratory tests, physical exams, and vital signs (including oxygen saturation) will be conducted periodically for safety. adverse events and medication use will be recorded. blood samples and intranasal samples will be collected periodically to assess the immune response from the vaccine.


Eligibility criteria:
inclusion criteria: 1. men and women aged 18 to 65 years of age, inclusive, on the day of signing the icf 2. body mass index (bmi) ≤ 35 kg/m2 3. in good health with no history, or current evidence, of clinically significant medical conditions with particular reference to, but not restricted to, thromboembolic disorders, coronary heart disease, chronic obstructive lung disease, and no clinically significant test abnormalities that will interfere with participant safety, as defined by medical history, physical examination, vital signs (including oxygen saturation), and safety laboratory tests as determined by the investigator 4. previous receipt of an authorised mrna or adenovirus-vectored covid-19 vaccine with completion of vaccine regimen ≥ 3 months before day 1 exclusion criteria: 1. residents of residential care facilities 2. pregnant or lactating women 3. inadequate venous access for repeated phlebotomy 4. history of confirmed or suspected sars-cov-2 infection

Keywords: covid-19 vaccines covid-19 vaccine booster shot heterologous prime boost covid-19 vaccination vaccines, attenuated
fetal and maternal outcome in preterm premature rupture of membranes (pprom)

Conditions: Premature Rupture of Membrane

Summary: the aim of this study is to compare fetal and maternal outcome in cases of pprom before 34 weeks versus after 34 weeks.

the data will be retrieved from the archival files and analyzed

Eligibility criteria:
inclusion criteria: * rupture of membrane exclusion criteria: * medical disorder