cyrilzakka/clinical-trials huggingface dataset:
Exploration of Dyspnea at Non-high Brain Natriuretic Peptide (BNP)

Patients with unexplained stress dyspnea ( ≥ stage 2 NYHA), no significant underlying lung disease, with an ejection fraction \> 50%, normal resting filling pressures, NTproBNP \< 220 pg/ml in \< 75 years, and \< 450 pg/ml in ≥ 75 years will be studied with stress echocardiography and cardiometabolic stress test (VO2). These patients may have abnormal adaptation during exercise, suggesting that chronic symptoms may be related to a heart failure with preserved ejection fraction (HFPEF). More accurate and earlier diagnosis of HFPEF using stress echocardiography and VO2 may better manage stress dyspnea in patients and prevent progression of HFPEF.

A clinical assessment will be offered to people with unexplained stress dyspnea. The procedures and products used in this study are usually used as part of HFpEF's diagnostic strategy. During this assessment, carried out on an outpatient basis, an anamnesis collection, a cardiovascular clinical examination, an evaluation of dyspnea by the NYHA functional class and by 2 questionnaires, an electrocardiogram will be carried out, a 6-minute walk test, a biological blood test, a trans thoracic rest and stress cardiac ultrasound, respiratory functional tests (with diffusion capacity of lung for carbon monoxide (DLCO) and blood gas), and a metabolic stress test. A follow-up at 1 and 2 years is planned (visit, sampling and resting echocardiography).


Eligibility Criteria:
Inclusion Criteria:

* Patient over 40 years of age, and under 80 years of age with unexplained effort dyspnea, able to pedal.
* Echocardiographic ejection fraction \> 50%
* NTproBNP \< 220 pg/ml in \< 75 years, and \< 450 pg/ml in ≥ 75 years

Exclusion Criteria:

* Patient with coronary, valve, hypertrophic, hypertensive, infiltrative, constrictive, or rhythmic, significant and/or progressive heart disease.

BMI \> 35 kg/m².

* Unstable patient (systolic blood pressure \< 90 mmHg, resting pulse \> 100 BPM) or clinically congested (edema of the lower limbs, crackling in the lungs).
* Patient with Pulmonary function testing (EFR) showing significant respiratory disease (FEV1/ vital capacity (CV) max \< 0.7, total lung capacities (CPT)\< LIN)
* Chronic renal failure with creatinine clearance \< 30 ml/min (MDRD) or dialysis
* Patient with anemia (Hb \< 12 g/dl)
* Patient with hypo or hyperthyroidism on thyreostimulating hormone (TSH) value
* Patient under justice safeguard measure or guardianship
Improving the Quality of Life of Elderly Individuals Living in Nursing Homes

The development of physical activity (PA) and exercise habits improves strength, flexibility, balance and coordination, activities such as walking, sleep quality and cognitive status in elderly people and supports their participation in social life. The aim of the study is to examine the effects of web-based Brain Breaks® (BB) video exercises (study group-WG) and posture and balance exercises (control group-CG) on the general physical condition, sleep quality and life satisfaction of elderly individuals. We expect this situation to improve the healthy lifestyle behaviors of elderly individuals.

This study, planned to be conducted in two nursing homes, was planned as Evaluation-BB Physical Activity/Posture and Balance Exercises-Evaluation-1 month follow-up. Participants' sociodemographic characteristics, blood pressure, pulse, respiration, height, weight, muscle strength and flexibility, walking performance, posture, sleep and quality of life and life satisfaction will be evaluated. After the first evaluation, 2-3 BB video exercises will be applied to the study group (total n = 140 videos, t = 3-4 min) and posture and balance exercises (t = 20 min) to the control group, two days a week for 8 weeks, for a total of 16 sessions. During the follow-up period, physical activity habits will be questioned through weekly telephone calls (n = 4). All statistical analyzes will be performed in SPSS 26.0 program, and p value \<0.05 will be considered statistically significant. Differences within and between groups and relationships between data and factors affecting these data will be examined.


Eligibility Criteria:
Inclusion Criteria:

* Being 65 years or older,
* There is no health problem determined by the doctor that prevents physical activity,
* Volunteering to participate in the study.

Exclusion Criteria:

* Having a serious life-threatening chronic disease or dementia,
* Having chronic or acute pain that prevents you from continuing to work,
* Having uncontrolled hypotension/hypertension, cardiovascular problems, metabolic and chronic diseases
A Study of an Anti-KIR Antibody Lirilumab in Combination With an Anti-PD1 Antibody Nivolumab and Nivolumab Plus an Anti-CTLA-4 Ipilimumab Antibody in Patients With Advanced Solid Tumors

To assess the safety and tolerability and preliminary anti-tumor activity of lirilumab (BMS-986015) given in combination with nivolumab (BMS-936558) and to identify dose limiting toxicities (DLTs) and the maximally tolerated dose (MTD) of the combination. In addition, to assess the combinations of lirilumab and nivolumab or lirilumab and nivolumab plus ipilimumab (BMS-734016) in subjects with advanced (metastatic and/or unresectable) refractory solid tumors.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* During dose escalation, subjects with advanced solid tumors (except for primary CNS metastases) that have progressed following at least one standard regimen
* During cohort expansion, subjects with various solid tumors that have received at least one and no more than 5 prior treatment regimens
* Subjects must have measurable disease
* Subject must consent to provide previously collected tumor tissue
* Women and men ≥18 years of age with performance status of 0 or 1
* At least 4 weeks since any previous treatment for cancer

Exclusion Criteria:

* Active or chronic autoimmune diseases
* Uncontrolled or significant cardiovascular disease
* Chronic hepatitis (except for subjects with hepatocellular carcinoma)
* Active infection
* Active Central nervous system (CNS) metastases
* Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome((HIV/AIDS)
* Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except for subjects with hepatocellular carcinoma)

Other protocol defined inclusion/exclusion criteria could apply
Effects of Oral Sildenafil on Mortality in Adults With PAH

This is a blinded study in adult patients with PAH evaluating the relative effects of sildenafil on mortality when administered at the three doses (80 mg, 20 mg or 5 mg, all three times per day \[TID\]). In addition, the relative effects on clinical worsening and 6-minute walking distance (6MWD) will be assessed.


Eligibility Criteria:
Inclusion Criteria:

Subjects ≥ 18 \<75 years of age with any of the following conditions:

* Idiopathic Primary Pulmonary Arterial Hypertension (IPAH)
* PAH secondary to connective tissue disease
* PAH with surgical repair (at least 5 years previously) of atrial septal defect (ASD),ventricular septal defect (VSD), patent ductus arteriosus (PDA) and aorto-pulmonary window
* PAH diagnosis confirmed by right heart catheterization performed within 12 months prior to randomization
* Functional Class II-IV; Baseline 6MWD ≥ 50 m.

Exclusion Criteria:

* Significant (ie, \>2+) valvular disease other than tricuspid regurgitation or pulmonary regurgitation
* History of cardiac arrest, respiratory arrest, hemodynamic collapse, CPR, ventricular tachycardia, ventricular fibrillation, or uncontrolled atrial fibrillation
* History of pulmonary embolism; History of chronic lung disease / restrictive lung disease (eg, chronic obstructive pulmonary disease (COPD) or scleroderma) with impairment of lung function
* No prior long term treatment with PDE-5 inhibitors
* Treatment with bosentan OR riociguat within 3 months of randomization
* Current treatment with nitrates or nitric oxide
Randomized Controlled Trial of Higher-Volume Feedings in Preterm Neonates

The primary hypothesis is that preterm infants who are less than or equal to 32 weeks gestation and weigh 1001-2500 grams at birth will have an increase in weight gain with a feeding goal of 180-200 ml/kg/day more than the commonly used feeding goal of 140-160 ml/kg/day

The proposed trial is designed to test the primary hypothesis that in preterm infants weighing 1001-2500 grams at birth and who are less than or equal to 32 weeks gestation, feeding goals of 180-200 ml/kg/day will increase weight gain (g/k/day) from time of enrollment to discharge home or 36 weeks post-menstrual age (PMA)(whichever comes first) more than the commonly used feeding goal volume of 140-160 ml/kg/day (usual feeding goal). This is a pilot study to determine the safety of increased volumes of feedings as opposed to fortification of feedings.

Eligibility Criteria:
Inclusion Criteria:

* Inborn or outborn infants born at a gestational age of 32 weeks or less; Birthweight 1001-2500; Feeding volume of at least 120 ml/kg/day; Enrolled prior to 28 days of age and prior to exceeding 32 weeks

Exclusion Criteria:

* Hemodynamically significant patent ductus arteriosis; History of necrotizing enterocolitis Bell Stage II or greater; Known gastrointestinal or neurologic malformations; Prior or planned enrollment into the NICHD MILK Trial; Terminal illness or decision to withhold or limit support
Pelvic Alignment in Relation to Standing Balance and Selective Motor Control in Children With Spastic Diplegia

This study will be conducted to identify the relation between pelvic alignment and standing balance and also the relation between pelvic alignment and selective motor control in children with spastic diplegic cerebral palsy.

In this study, pelvic alignment of children with diplegia will be evaluated using the Formetric instrument system. Their standing balance will be evaluated using the Biodex balance system, while selective voluntary motor control of lower extremities will be assessed using the Selective Control Assessment of the Lower Extremity scale (SCALE).

Results will be compared to find the correlation between pelvic alignment and standing balance and the correlation between pelvic alignment and selective motor control. Results can help clinicians to better address the problems of pelvic asymmetry in children with spastic diplegia to improve their overall balance and functional abilities.

Eligibility Criteria:
Forty children with spastic diplegia of both sexes will be selected with the following criteria:

Inclusion Criteria:

1. Their age will be ranged from 6 to 8 years.
2. The degree of their spasticity will be ranged from 1 to 1+ according to Modified Ashworth' Scale.
3. They will be on level Ⅰ or Ⅱ on Growth Motor Function Classification System (GMFCS).

Exclusion Criteria:

The Children will be excluded if they have one of the following:

1. Severe visual or hearing impairment.
2. Fixed deformities or surgical interventions in the lower extremities.
3. Botulinum toxin injections in the last 6 months.
Power Production in Older Adults With Knee Osteoarthritis

Knee osteoarthritis is an important cause of functional disabilities at old age. Previous research has demonstrated that individuals with knee osteoarthritis have reduced knee-extensor strength in comparison to healthy individuals. However, rapid power production declines more than strength as a consequence of ageing and is more predictive of functional capacity. However, limited research has investigated whether individuals with knee osteoarthritis have reduced ability to develop strength and power rapidly on top of reduced maximal strength capacities, which is the primary aim of the current study.


Eligibility Criteria:
Inclusion Criteria:

Group with knee osteoarthritis:

- Diagnosed with knee osteoarthritis based on RX.

Exclusion Criteria:

Healthy group:

* Systematic engagement in (resistance) exercise in the 12-months prior to participation
* Cardiovascular disease
* Neurological disorders
* Cognitive malfunctioning
* Severe knee or hip problems

Group with knee osteoarthritis:

* Systematic engagement in (resistance) exercise in the 12-months prior to participation
* Cardiovascular disease
* Neurological disorders
* Cognitive malfunctioning
* Severe hip problems
The Prevalence of Metabolic Liver Disorders in Children

Aim of study :

To detect the prevalence of metabolic liver disease in patients attending gastroenterology and hepatology unit at assuit university children hospital.

Metabolic Liver Disease is a group of metabolic disorders that stops the liver to function or fail. These metabolic conditions affect the pathways in the liver cells - the pathways that help the body break down, absorb, process, transport, and store nutrients like amino acids, carbohydrates and fats.

Metabolic liver diseases (MLD), an inborn error of metabolism, is caused by defect of single enzyme or transport protein resulting into abnormality in synthesis or catabolism of carbohydrate, protein and fat.

The pathogenesis of MLD can be divided into three groups:

1. Defect in the intermediary metabolic pathway leading to accumulation of toxic metabolite (ex : Galactosemia, Tyrosinemia type 1)
2. Involvement of cellular organelles : (Wolman's disease and Zellweger's syndrome)
3. Energy deficiency states (Mitochondrial or Cytoplasmic):(ex : fatty acid oxidation defects (FAOD) and the congenital lactic acidemias) The MLDs can present at any age, from prenatal, neonatal, infancy to adolescence and even adulthood, coinciding with the time of maximum catabolism. From the therapeutic point of view, the MLDs can be divided into four time periods e.g., neonatal age, at the time of infections, puberty and pregnancy. The diagnosis is often delayed as the symptoms may be intermittent, and in the period between episodes of decompensation, the patient may be free of clinical or biochemical abnormalities.

MLD can have varied presentations in infants and children, most common of them being: (i) organomegaly, (ii) encephalopathy due to hyperammonemia and/or primary lactic acidemia, (iii) pediatric acute liver failure (ALF), (iv) cirrhosis with or without portal hypertension, and (v) cholestatic liver disease.A high index of suspicion for MLD is important as urgent intervention such as dietary manipulation or disease-specific treatment may be life- saving.The outcome of patients undergoing liver transplantation for MLD has improved considerably over the last decade.Moreover, it is important to establish the correct diagnosis, so that appropriate genetic counselling can be offered to the family.MLD merit special attention in differential diagnosis of pediatric ALF, especially in infants and young children in whom they constitute 13- 43% of all cases .

MLDs represent 10-15% of all causes of acute liver failure in children \<18 years old, with a mortality of 22-65%. In children \<2-3 years of age, the percentage of acute liver failure caused by MLD rises to 33-53%.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with undiagnosed chronic hepatomegaly
2. Patients with unexplained chronic increased liver enzymes
3. Patients with undiagnosed chronic hepatomegaly or unexplained chronic increased liver enzymes and multi organ affection ( convulsions , coarse features

Exclusion Criteria:

* Patients with hepatic disorder or hepatitis with diagnosis other than metabolic ( infection ,toxic and etc ...)
Green Propolis Extract and Royal Jelly in Hypertensive Patients and/or With Chronic Kidney Disease

This work aims to evaluate the effects of the association of green propolis extract with royal jelly on inflammation and oxidative stress in participants with chronic kidney diseases (CKD) and Systemic arterial hypertension (SAH), in a longitudinal, randomized, double-blind, placebo-controlled clinical trial that will be carried out for 2 months.

Propolis and royal jelly are bee products. Propolis is a resinous mixture produced by bees with their saliva and the addition of wax, from exudates collected from buds and plant sap. Royal jelly is a substance produced in the hypopharyngeal glands of young worker bees. Both products are rich in bioactive compounds such as polyphenols. The combination of propolis extract and royal jelly, substances constituted by the combination of several chemical components with potential biological activity, may emerge as a promising adjuvant therapeutic alternative for patients with CKD and SAH.

Eligibility Criteria:
Inclusion Criteria:

* patients in stages 3 and 5 of CKD (GFR from 15 to 59 mL/min),
* patients receiving ambulatorial nutrition treatment at least 6 months
* patients on regular Hemodialysis treatment for at least 6 months
* patients using one to three antihypertensive drugs

Exclusion Criteria:

* autoimmune and infectious diseases,
* diabetes
* cancer
* AIDS
* pregnant women
* patients using catabolic drugs or antibiotics;
* patients with catheter access to hemodialysis;
* patients using antioxidant vitamin supplements, prebiotics, probiotics, symbiotic,
* Patients on regular intake of propolis who are allergic to corn starch or report being allergic to bee stings.
* patients with acute myocardial infarction (AMI) and/or cerebrovascular accident (CVA)
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - Nested Registry 3/Valve-in-Valve

To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients with a failing surgical aortic bioprosthetic valve.

A prospective, single-arm, multicenter clinical trial. The trial will enroll patients with a failing surgical bioprosthetic valve in the aortic position demonstrating stenosis and/or insufficiency. This is a PARTNER II nested registry.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient \>40 mmHg or jet velocity greater than 4.0 m/s and an initial aortic valve area (AVA) of ≤0.8 cm2 or indexed EOA \< 0.5 cm2/m2. Qualifying echo must be within 60 days of the date of the procedure.
2. Patient was symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
3. The heart team agreed (and verified in the case review process) that valve implantation would likely benefit the patient.
4. The study patient or the study patient's legal representative was informed of the nature of the study, agreed to its provisions and had provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
5. Heart team consensus that the risk of surgical mortality or major morbidity ≥ 50%.
6. Stenosed or insufficient surgically implanted bioprosthetic valve in the aortic position.

Exclusion Criteria:

1. Bioprosthetic valve labeled external diameter \< 21mm.
2. Surgical or transcatheter valve in another position on the same side of the heart (mitral and tricuspid rings are not an exclusion).
3. Infectious endocarditis within 6 months.
4. Acute myocardial infarction ≤ 1 month (30 days) before the intended treatment.
177Lu-DTPA-Omburtamab Radioimmunotherapy for Recurrent or Refractory Medulloblastoma

Children and adolescents diagnosed with medullablastoma and with recurrent or refractory to frontline therapy will be treated with 177Lu-DTPA-omburtamab, which is a radioactive labelling of a murine monoclonal antibody targeting B7-H3.

Part 1 is a dose-escalation phase with a 3+3 sequential-group design in which patients will receive a dosimetry dose followed by maximum of two 5-week cycles of treatment doses of intracerebroventricular 177Lu-DTPA-omburtamab.

Part 2 is a cohort-expansion phase in which patients will receive a maximum of five 5-week cycles of intracerebroventricular 177Lu-DTPA-omburtamab at the recommended dose determined in Part 1.

End of treatment will take place within 5 weeks after the last cycle and thereafter the patients will be enter the follow-up period. The patients will be followed for up to 2 years after last dose.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of medulloblastoma.
* SHH, Group 3, or Group 4 according to World Health Organisation (WHO) 2016 classification.
* Recurrent (maximum of 2 recurrences for Part 1 and 1 recurrence for Part 2) or refractory to frontline therapy. Prior frontline or second line therapy may involve surgery, craniospinal irradiation, stereotactic radiosurgery, and multi-agent chemotherapy regimens.
* Have refractory disease, focal or multifocal recurrent disease, or pure leptomeningeal disease. Cytological or radiographic remission is allowed; however, not simultaneously.
* Performance status score of 50 to 100 on Lansky (less than 16 years) or Karnofsky (16 years or older) scales.
* Life expectancy of at least 3 months, as judged by the Investigator.
* Acceptable hematological status and liver and kidney function.

Exclusion Criteria:

* Obstructive or symptomatic communicating hydrocephalus as determined by Ommaya patency/cerebrospinal fluid (CSF) flow study.
* Residual disease (nodular or linear) measuring \> 15 mm in the smallest diameter.
* Ventriculoperitoneal shunts without programmable valves. Ventriculo-atrial or ventriculo-pleural shunts.
* Grade 4 nervous system disorder. Stable neurological deficits (due to brain tumor or surgery) or hearing loss are allowed.
* Uncontrolled life-threatening infection.
* Received radiation therapy less than 3 weeks prior to the screening visit.
* Received systemic or intrathecal cytotoxic chemotherapy or intrathecal immunotherapy (corticosteroids not included) less than 3 weeks prior to the screening visit.
* Received any prior anti-B7-H3 treatment.
* Non-hematologic organ toxicity Grade 3 or above; specifically, any renal, cardiac, hepatic, pulmonary, and gastrointestinal system toxicity.
* Other significant disease or condition that in the investigator's opinion would exclude the patient from the trial.
Monocyte Subsets Altered by Anesthesia

The impact of different anesthetic techniques on the immune system remains unclear.

Aim of this ex vivo / in vitro study was to determine the effects of general and neuraxial anesthesia on monocyte subset alteration and the release of prototypical pro- and anti-inflammatory cytokines. Twenty patients undergoing total knee replacement surgery were randomly assigned to receive either general anesthesia (ITN) or combined spinal/epidural anesthesia (CSE). CD14 and HLA-DR expression patterns on monocytes and intracellular TNF-alpha production were quantified via flow cytometry. TNF-α and IL-10 release were measured via enzyme linked immunosorbent assay (ELISA).

Numerous of factors affect the immunological response during surgery. Despite intensive research, the impact of different anesthetic techniques on the immune system remains unclear.

Aim of this ex vivo / in vitro study was to determine the effects of general and neuraxial anesthesia on monocyte subset alteration and the release of prototypical pro- and anti-inflammatory cytokines. Twenty patients undergoing total knee replacement surgery were randomly assigned to receive either general anesthesia (ITN) or combined spinal/epidural anesthesia (CSE). Samples of venous blood were taken from the patients before and after induction of anesthesia, immediately, 6 hours, 24 hours, and 48 hours after surgery. All blood samples were incubated in presence or absence of LPS (lipopolysaccharide; 1 µg/ml) for 24 hours. CD14 and HLA-DR expression patterns on monocytes and intracellular TNF-alpha production were quantified via flow cytometry. TNF-α and IL-10 release were measured via enzyme linked immunosorbent assay (ELISA).

Eligibility Criteria:
Inclusion Criteria:

* Total knee replacement surgery
* 18 years or older

Exclusion Criteria:

* clinical signs of infection,
* neoplasia
* treatment with immunomodulatory agents
* any kind of immune mediated disease.