cyrilzakka/clinical-trials huggingface dataset:
Umbilical Cord Mesenchymal Stem Cells Transplantation in the Treatment of Bronchopulmonary Dysplasia

To evaluate the safety and efficacy of human umbilical cord mesenchymal stem cells transplantation in patients with bronchopulmonary dysplasia

The purpose of this study is to evaluate the safety and effectiveness of human umbilical cord mesenchymal stem cells in 10 patients with bronchopulmonary dysplasia at Vinmec International Hospital, Hanoi, Vietnam

Eligibility Criteria:
Inclusion Criteria:

* The patient is diagnosis Bronchopulmonary Dysplasia (premature and depends on oxygen until 28 days old
* Gender: either sex
* Year old \< 6 months
* Weight ≥ 2 kg
* Agree to participate in the study.

Exclusion Criteria:

* Severe congenital malformation.
* Other severe conditions (active pulmonary bleeding, evidence of active infections).
Minimally Invasive Transthoracic Device Closure in Perimembranous Ventricular Septal Defect

The purpose of this study is to evaluate the efficacy and safety of minimally invasive transthoracic device closure of ventricular septal defect. This is a multi-center randomized controlled trial. Because of the characteristics of this surgical clinical trials, surgeons, ultrasonic department doctors, anesthesiologists, operating room nurses and intensive care unit nurses are all need to be informed. Therefore the results of this trial need to be system evaluated through objective methods to reduce bias.

Several examinations need to be done in all the patients, including X-ray, electrocardiogram, echocardiogram, blood routine examination, liver and kidney function, electrolytes, coagulation function and infectious index checks. And they will be divided into two groups after they have obtained informed consent: surgical group (50 cases); closure group (50 cases). If the closure failed, the patients in closure group will be converted to surgical repair with cardiopulmonary bypass .

Recheck X-ray, electrocardiogram, echocardiogram, blood routine examination, liver and kidney function and electrolytes need to be done in all the patients two days after operation. The patients were followed up by X-ray, electrocardiogram, echocardiogram at the first month, third month, sixth month and the first year.

Eligibility Criteria:
Inclusion Criteria:

* Age≥3 months
* Patients with isolated perimembranous ventricular septal defect with hemodynamic abnormalities. Diameter of the defect is greater than 3mm, and less than 10mm

Exclusion Criteria:

* Para adverse ventricular septal defect
* Muscular ventricular septal defect, subpulmonic ventricular septal defect and septal leaflet posterior atrioventricular canal ventricular septal defect
* Patients with severe pulmonary hypertension in right-to-left shunt
* Patients with obvious aortic valve prolapse, with moderate or severe aortic regurgitation
* Infective endocarditis, and heart cavity neoplasm
* Patients with other cardiovascular malformations, which require surgery with cardiopulmonary bypass to correct at the same period
Effect of Mother's Touch and Nurse's Therapeutic Touch on Pain Level and Crying Time During Heel Blood Collection

This prospective study is planned as a randomized controlled study with the purpose of determining the effect of Mother's Touch and Nurse's Therapeutic Touch on pain levels and crying times by newborns during heel blood collection.

Among the non-pharmacological methods frequently used to reduce the effects of invasive interventions on the newborn; Practices such as reducing environmental stimuli, individualized developmental care, music therapy, breast milk, pacifier giving, sucrose, non-nutritive sucking, oral sucrose, kangaroo care, facilitated tucking position, and sweet solutions, massage and touching, positioning, nesting, kangaroo care, fetal positioning are included.

This study is a prospective, randomized and controlled trial. In this study aim, the effect of Mother's Touch and Nurse's Therapeutic Touch applied during heel blood collection on the pain levels and crying times in newborns will be examined.

Sample of the study consisted of a total of 120 newborns who met the sample selection criteria and were selected via randomization method. Newborns were divided into three groups; Mother's Touch group, Nurse's Therapeutic Touch group, and Control group.

Data were collected using the Infant-family Information Form, NIPS-Neonatal Infant Pain Scale, and Crying Follow-up Form.

Eligibility Criteria:
Inclusion Criteria:

* Parents who volunteered and gave consent to participate in the research
* Full term neonates (38-42 weeks of gestation)
* Underwent heel stick blood drawing for routine metabolic screening
* Aged 1 to 4 days
* Passed the hearing screening
* Birth weight between 2500-4400 grams
* Parents who know how to read, write and speak Turkish.

Exclusion Criteria:

* Parents with any mental problems
* Infants with any chronic disease and congenital anomalies.
Non-operative Management of Early Appendicitis in Children

The purpose of this study is to determine the feasibility of non-operative management of early appendicitis in children. We hypothesize that non-operative management of early appendicitis in children with antibiotics alone will be successful in 80% of children at 1 year follow-up.

Non-operative management of appendicitis with antibiotics alone has recently emerged as a viable treatment alternative to appendectomy. There have been several clinical trials in adults which conclude that antibiotics alone are a safe initial treatment for appendicitis; none of these studies included children.

The primary objective of this study is to determine: conversion to surgery (failure of nonoperative management), 30 day, 6 month and 1 year recurrence rate of appendicitis in children treated with non-operative management. Recurrence is defined as need for appendectomy. The secondary objective is to compare adverse outcomes, length of stay, days to return to school, costs of care and quality of life measures between the study group and those that receive standard of care.We hypothesize that non-operative management of early appendicitis in children with antibiotics alone will be successful in 80% of children at 1 year follow-up.

This is a prospective, non-randomized single-site trial measuring the feasibility of treating children (7-17 years old) with early appendicitis with antibiotics only (non-operative management). There will be two cohorts; those who agree to receive non-operative management (Non-Operative Group) and those that permit us to track their standard treatment course (Surgery Group).

Eligibility Criteria:
Inclusion Criteria:

* Age : 7-17 years
* Ultrasound (US) or CT scan confirmed early appendicitis (US: hyperemia, \<1.1 cm in diameter, compressible or non-compressible, no abscess, no fecalith, no phlegmon; CT: hyperemia, fat stranding, \<1.1 cm in diameter, no abscess, no fecalith, no phlegmon)
* White blood cell count (WBC) \< 15,000
* C reactive protein (CRP) \<4 (if obtained)
* Focal abdominal pain \</= 36 hours prior to receiving antibiotics

Exclusion Criteria:

* English is not the primary language of either the child or parent/guardian
* Other significant co-morbidities: cardiovascular disease, malignancy, pulmonary disease, diabetes, obesity (BMI ≥ 95th percentile for age and sex), severe developmental delay
* Positive urine pregnancy test
* Diffuse peritonitis
* Fecalith
* History of chronic intermittent abdominal pain
* WBC \>/= 15
* CRP\>/= 4 (if obtained)
* Pain \> 36 hours prior to first antibiotic dose or any evidence on imaging studies concerning for evolving perforated appendicitis including abscess or phlegmon
Study of Celecoxib Bioavailability in Healthy Subjects

To evaluate the bioavailability of celecoxib administered as capsule contents sprinkled onto applesauce relative to intact capsule


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects

Exclusion Criteria:

* Standard criteria for healthy volunteer studies
Early Intervention in Allergic Patients

As many as 250 million people suffer from allergic rhinitis in China, which has a large population, early use of drugs may help better control the symptoms.This study aimed to investigate the effects of early interventional treatment with the leukotriene receptor antagonist (LTRA) montelukast on seasonal allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* patients showed distinct nasal symptoms (rhinorrhea, congestion, itching, and sneezing), and demonstrated sensitization to one of the grass pollen allergens (Artemisia, Chenopodium, and Humulus scandens) with an immunoglobulin (Ig) E ≥ 0.7 IU/mL, measured using the Pharmacia UniCAP system (Thermo Fisher Scientific China Co., Ltd., Shanghai, China).
* had not received any therapies for AR or antibiotics for at least 4 weeks before their outpatient clinic visit prior to the study
* all of the subjects in the study reside in Beijing.

Exclusion Criteria:

* Patients diagnosed with bronchial asthma, suffering from rhinitis outside the pollen season, chronic sinusitis, deviated nasal septum, using specific immunotherapy, or participating in another drug efficacy trial during the 4-week period preceding the study.
* pregnant women and minors
Dose-Escalation Safety Study of HPN-100 to Treat Urea Cycle Disorders

The purpose of this study is to determine whether HPN-100 is safe and tolerable in subjects with Urea Cycle Disorders.

When protein is broken down in the body, nitrogen is formed. In healthy individuals, the body combines this nitrogen with other molecules to create a harmless substance called urea, which is excreted in the urine. Patients with Urea Cycle Disorders (UCD) are unable to create as much urea from nitrogen, and therefore, toxic levels of nitrogen can accumulate in the body, causing harm. To treat these patients, doctors usually have the patient consume less protein and supplement certain amino acids that may be lacking. A drug called Buphenyl® is sometimes prescribed as an adjunctive treatment for the chronic maintenance of UCD patients in order to keep ammonia levels down. Some issues with Buphenyl® include a high pill burden (up to 40 pills per day), bad taste and odor, and high sodium content. Like Buphenyl®, HPN-100 provides an alternate way for the body to dispose of nitrogen, other than through the urea cycle. Unlike Buphenyl®, HPN-100 is an odorless, tasteless, concentrated oil that does not contain large amounts of sodium.

Study acquired from Horizon in 2024.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients at least 18 years old
* Signed written informed consent by patient or patient's representative
* Diagnosis of urea cycle enzyme deficiency confirmed via enzymatic or genetic testing
* Currently treated with Buphenyl® TID for a minimum of 2 weeks prior to Visit 1
* Able to perform study activities (including the ability to collect all urine in the clinic, i.e., no patients in diapers)
* Negative pregnancy test for all females of childbearing potential. All females of childbearing potential must agree to use an acceptable method of contraception throughout the study

Exclusion Criteria:

* Use of any investigational drug within 30 days of Buphenyl® Visit 1
* Active infection (viral or bacterial) or any other condition that may increase ammonia levels
* Laboratory values outside the normal range that are determined to be clinically significant by the investigator
* Any clinical or laboratory abnormality of Grade 3 or greater severity according to the Common Terminology Criteria for Adverse Events v3.0 (CTCAE) (or for conditions not covered by the CTCAE, a severe or life-threatening toxicity); except that Grade 3 elevations in liver enzymes are allowed in an otherwise clinically stable patient
* Use of any medication known to significantly affect renal clearance (e.g., probenecid) or to increase protein catabolism (e.g., corticosteroids), or other medication (e.g., valproate) known to increase ammonia levels, within the 24 hours prior to Visit 1
* Preexisting QTc interval prolongation (\> 450 msec for males or \> 460 msec for females)
* Other severe chronic medical conditions
* Known hypersensitivity to PAA, PBA, or benzoate
* Creatinine levels equal to or greater than 1.5 × ULN
* Liver transplant
Is Early Second Trimester Vaginal Ultrasound Scan Associated With Adverse Perinatal Outcomes?

Many pregnant women have an ultrasound done of their fetus in the beginning of the second trimester of pregnancy. Some have a transvaginal sonography while others have a transabdominal one, depending on clinical parameters such as weight, scars etc. In the transvaginal ultrasound there is some amount of version of the fetus done by the examiner to maintain a better aspect of the fetus, while this is not done in a transabdominal sonography.

The objective of this trail is to determine whether having a transvaginal ultrasound as opposed to a transabdominal one has an association to adverse perinatal outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who choose to have a ultrasound done in the early second trimester.

Exclusion Criteria:

* More than one fetus,
* No agreement to participate in the study,
* Malformative fetus.
Docetaxel Plus Bevacizumab in Metastatic Non Small Cell Lung Cancer

This trial will evaluate the efficacy and safety of docetaxel plus bevacizumab in patients with pretreated, advanced non small cell lung cancer (NSCLC).

Docetaxel is and an effective cytotoxic agent in \> 1st line treatment of advanced or metastatic non small cell lung cancer (NSCLC). Recently, a phase III study of 1st line treatment in patients with advanced or metastatic NSCLC showed that the addition of bevacizumab to a platinum-based regimen provided a survival benefit. There are patients with NSCLC who have not received bevacizumab and have relapsed after 1st and/or 2nd line therapy. The evaluation of bevacizumab plus chemotherapy in such patients is justified. This study will evaluate the combination of docetaxel and bevacizumab as 2nd or 3rd line treatment of NSCLC.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed,
* Unresectable locally advanced (stage IIIB) or metastatic (stage IV) non-squamous NSCLC
* At least one and no more than two previous chemotherapy regimens for advanced - or metastatic NSCLC
* Measurable disease, defined as at least 1 bidimensionally measurable lesion ≥ 20 X 10 mm.
* Age ≥ 18 years.
* Performance status (WHO) 0-2.
* Life expectancy of at least 12 weeks.
* Adequate bone marrow (ANC ≥ 1,500/mm3, PLT ≥ 100,000/mm3, Hgb ≥ 11 g/dL), liver (Bilirubin ≤ 1.5 Upper normal limit, SGOT/SGPT ≤ 2.5 Upper normal limit in the absence of liver metastases or ≤ 5 Upper normal limit in the presence of liver metastases), and renal function (Creatinine ≤ 1,5 Upper normal limit).
* Patients must be able to understand the nature of this study and give written informed consent

Exclusion Criteria:

* Previous therapy with docetaxel
* Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
* Pregnant or lactating women
* Any serious, uncontrolled comorbidity on the investigator's judgment. Uncontrolled infection
* Any sustained chronic toxicity \> grade 2 according to the NCI CTCAE (version 3.0)
* Symptomatic neuropathy \> grade 2 according to the NCI CTCAE (version 3.0)
* Brain metastases, except if radiated and asymptomatic
* Radiotherapy within the previous 4 weeks
* Previous radiotherapy to the only measurable lesion
* Proteinuria ≥ 500 mgr of protein daily
* Hemoptysis \> 10 cc per event
* Clinically significant hematemesis
* Centrally located lesion or in contact with major vessels
* Pulmonary lesion with cavitation
* Documented hemorrhagic diathesis or coagulation disorder
* Cardiovascular disease (class II-IV NYHA congestive heart failure, myocardial infarction within the previous 4 months, unstable angina, LVEF \< normal, ventricular arrhythmia, uncontrolled hypertension)
* Thrombotic event within the previous 6 months
* Concurrent use of aspirin \> 325 mgr daily, low molecular weight heparin in therapeutic dose, warfarin or acenocoumarol, non-steroid anti-inflammatory agents
* Concurrent treatment with other anti-cancer drug
* Major surgical procedure within the previous 4 weeks
Prevalence of Asthma and Rhinitis Symptoms Among Secondary School Students in Saudi Arabia

The purpose of this cross-sectional survey study is to describe the prevalence of asthma and Rhinitis symptoms among secondary school students in Saudi Arabia.

Cross sectional survey based on ISAAC protocol to characterize the symptoms of asthma and rhinitis and measure their frequency and its prevalence among secondary schools students (age 15 to 18 years, boys and girls) in Riyadh city, Saudi Arabia in period from 1st of April 2010 to 31st of May 2010.

The ISAAC protocol stated that the study population should consist of at least 3,000 students aged 15-18 years- in this case, enrolled in at least 40 randomly selected schools.

The 15-18 year age group was chosen because it is the age most adolescents go to school regularly, making data collection easier. Once requested by the research team, the education authority will provide a list of all secondary schools in Riyadh city and the number of students by school and their grades.

There are 400 secondary schools for boys and 400 school for girls (total number of boys and girls students 50,000).

A two stage stratified random sample of 4000 students will be selected out of secondary schools for boys and girls , Their ages range from 16 to 18 years.

Eligibility Criteria:
Inclusion Criteria:

* 15:18 year age group

Exclusion Criteria:

* Younger than 15 years or older than 18 years
Virtual Reality in Reducing Pain and Anxiety in Cancer Participants Undergoing Painful Procedures

This trial studies how well virtual reality (VR) works in reducing pain and anxiety in cancer participants undergoing bone marrow biopsy or lumbar puncture. Virtual reality may impact pain and anxiety during and after the procedure.

PRIMARY OBJECTIVES:

I. To determine the feasibility of VR in patients undergoing procedural intervention.

SECONDARY OBJECTIVES:

I. To estimate differences between the two arms in terms of pain and anxiety. II. To document any adverse events that could possibly be attributed to the VR intervention.

EXPLORATORY OBJECTIVES:

I. Explore the use of biomarkers as a tool to reflect the impact of intervention.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants undergo VR intervention peri-procedure (bone marrow biopsy or lumbar puncture) lasting until completion of the procedure.

ARM II: Participants receive standard of care during procedure (bone marrow biopsy or lumbar puncture).

Eligibility Criteria:
Inclusion Criteria:

* Patient has been diagnosed with any cancer
* Patient is currently hospitalized and receiving treatment for a primary or secondary cancer at University of Southern California (USC) Norris Comprehensive Cancer Center and Hospital
* Patient is undergoing a bone marrow biopsy or lumbar puncture

Exclusion Criteria:

* Inability to sign informed assent and/or consent
* Patient with an underlying diagnosis of epilepsy, dementia, Parkinson?s disease, primary central nervous system malignancy, brain metastasis, underlying inflammatory or infectious central nervous system disorder, inner ear infection, history of vertigo, baseline visual or hearing impairment, macular degeneration, untreated glaucoma, implantable medical devices or any medical condition that investigator deems contraindicated
* Patient with an underlying chronic pain disorder, anxiety disorder, depressive disorder, or other psychiatric illness unspecified
* Patient with active Clostridium difficile infection
* Patient on any acute (within last \< 24 hour \[hr\]) or chronic pain medication (opioid, nonsteroidal anti-inflammatory drug \[NSAID\], steroid)
* Patient on chronic steroids \> 10 mg prednisone equivalent daily or other immunosuppressant \> 1 week
* Patient who is post bone marrow transplant
* Patient with a body mass index (BMI) \> 35
Choroid In Coronary Artery Disease

Purpose: To investigate any relationship between choroid thickness (CTh) and coronary artery disease (CAD), particularly in its earlier stages before clinically evident.

Design: Retrospective, cross-sectional observational study

Methods:

Setting: The study was performed in two institutions; patients were recruited in Balikesir City Hospital. The ophthalmological examinations and coronary angiograms were performed in Balikesir City Hospital. The analysis of the coronary angiograms including Gensini scoring were conducted in Bursa Education and Research Hospital.

Study Population: The study group comprised 68 patients with documented CAD and 60 healthy control subjects. Patients with high myopia, cataracts, retinal vascular disease, retinal surgery, retinal dystrophy, laser photocoagulation, intravitreal anti-VEGF treatment, glaucoma, uveitis, retinal disorders, any systemic diseases were excluded from the study groups.

Observation Procedure: Refractive examination, corrected visual acuity, intraocular pressure measurements, anterior and posterior segment examinations. Following measurements of macular thickness and retinal nerve fiber layer, choroidal thickness of both eyes was assessed by enhanced depth imaging optical coherence tomography.


Eligibility Criteria:
Inclusion Criteria:

* Normal coronaries at coronary angiography for healthy control group
* Without any coronary artery disease equivalent diseases such as peripheral artery disease, cerebrovascular disease and stroke for healthy control group
* Ability to give informed consent for the study
* Coronary artery disease with stenosis detected in coronary angiogram for coronary artery disease group

Exclusion Criteria:

* High myopia (\> 6D)
* Cataracts
* Retinal vascular disease
* Retinal surgery
* Retinal dystrophy
* Laser photocoagulation
* Intravitreal anti-VEGF treatment
* Glaucoma
* Uveitis
* Retinal disorders (comprising diabetic macular edema, diabetic/hypertensive retinopathy, vein occlusions, retinal dystrophy, epiretinal membrane, vitreomacular traction, age-related macular degeneration)
* Any systemic diseases
* Obesity (body-mass index ≥30 kg/m²)