cyrilzakka/clinical-trials huggingface dataset:
Role of Lung Ultrasound In Assessment Of Recruitment Maneuvers In Ventilated Preterms With Respiratory Distress Syndrome and Its Correlation With Tracheal IL-6 Level

This work is designed to:

1. Evaluate the efficacy of lung ultrasonography in detecting opening and closing lung pressures in ventilated preterm neonates with respiratory distress syndrome.
2. Determine the efficacy of lung ultrasonography in optimizing lung volume and its correlation with pulmonary inflammatory reaction as evidenced by IL-6 level in tracheal aspirate.

The studied population included 44 preterm infants. Anthropometric measurements, gestational age, sex, mode of delivery, maternal disease and Apgar score were found to be matched in the two studied groups indicating successful randomization as seen in these balanced demographic variables between the groups.

The studied population included 44 preterm infants. Then they were allocated randomly to one of 2 groups in order by admission:

Group A: included 22 patients on whom the recruitment maneuver was applied guided by lung ultrasonography.

Group B: included 22 patients on whom the recruitment maneuver was not ultrasound guided. This is considered the control group.

Anthropometric measurements, gestational age, sex, mode of delivery, maternal disease and Apgar score were found to be matched in the two studied groups indicating successful randomization as seen in these balanced demographic variables between the groups.

Eligibility Criteria:
Inclusion Criteria:

1. Gestational age ≤ 36 weeks.
2. In need for invasive mechanical ventilation for RDS according to Downes Score .

Exclusion Criteria:

* excluded:

  1. Major upper or lower airway anomalies.
  2. Significant congenital anomalies including cardiac, abdominal or respiratory.
  3. Surgical cases
  4. Inborn errors of metabolism
  5. Early onset sepsis.
  6. Meconium aspiration syndrome.
  7. Hypoxic ischemic encephalopathy.
Evaluation of Long-Term Continuity of Exercises in Low Back Pain Individuals

Identification of the long term effects of exercises in individuals with low back pain.

Individuals with low back pain who will participate in the study will be divided into two groups. In the stabilization exercise group will be instructed to perform spinal stabilization exercises and in the yoga group will be instructed to perform yoga program consisting of breathing, relaxation and flexibility exercises. The intensity of the pain will be evaluated through visual analog scale, functional status and quality of life will be evaluated through Oswestry Disability Index(ODI), Nottingham Health Profile (NHP), respectively. The exercise adherence will evaluated Exercise Adherence Rating Scale (EARS). The time-distance characteristics of the gait will be evaluated by the OPTOGAIT photoelectric cell (OPTOGait, Microgate, Italy, 2010) and the treadmill system. Assessments will be repeated before, after the treatment, 6 and 12 month follow-up. Also,the number of back pain attacks of the individuals will be questioned and recorded.

Eligibility Criteria:
Inclusion Criteria:

* Must be low back pain at least 3 months
* Must be visual analog scale rating 3 or more

Exclusion Criteria:

* History of any lumbar spine surgery
* Severe/progressive scoliosis
* Spinal stenosis
* Spondylolisthesis
* Cancer
* Diabetes
* Metabolic syndrome
* History of exercise programs or yoga at least 12 weeks before the onset of study
Volume Estimation of the Limb After VEnous Treatment

Chronic venous disease encompasses a broad spectrum of clinical presentations and is considered the most common vascular disease. Its causes are diverse, including primary defects of the wall or valves, chronic venous insufficiency, or lesions secondary to thrombosis, a post-thrombotic venous disease, affecting the superficial or deep venous network or both. The major symptom of venous disease is the enlargement of the lower limbs, which can result in edema. The evaluation of the volume of the lower limbs is very important in the diagnosis and follow-up of the venous pathology. There is a great variability of clinical pictures making it difficult to choose the therapeutic gesture. Endovascular venous interventions and conventional venous surgery are major advances in the treatment of venous disease. The variation of lower limb volume in pre and post procedure is a determining factor; thus orienting clinicians for post interventional therapeutic monitoring. Indeed the management of venous disease is multidisciplinary, it involves the cooperation of several specialists as part of its monitoring and its therapeutic management. Our collaborative group includes the Adult and Child Vascular Investigations Department, the Vascular Clinic, the Cardiovascular and Thoracic Surgery Department, and the Interventional Radiology Department. The evaluation of the variation of the volumes of the lower limbs is a capital data for the various specialists for the care in pre and post procedure. A volumetric 3D scanner system guarantees a reliable measurement ensuring optimal evolution and therapeutic follow-up.

At admission eligible patients are proposed to participate. Written consent is signed after complete oral and written explanation of the protocol is signed. No register of non-included patients will be kept.

In included patients, in parallel to the routine ultrasound investigation for which the patient is referred, the evaluation of the variation of the volumes of the lower limbs with the volumetric 3D scanner will be performed as explained later in arm description.

Usual ongoing treatments are obtained by history and recorded. The end of the visit is the end of the participation of the subjects.

Eligibility Criteria:
Inclusion Criteria:

* subjects referred for investigation of a preoperative venous assessment
* affiliation to the French National healthcare system
* french speaking patients

Exclusion Criteria:

* pregnancy
* inability to understand the study goal
* patients protected by decision of law
Effects of the Concentrated Extract of Soy on Coagulation Factors After Menopause

Hypoestrogenism, common in menopause, is responsible for systemic and metabolic changes affecting women's wellness, favoring hot flashes, urogenital atrophy and bone mass loss. Hormone reposition therapy (HRT) with estrogen or estrogen associated to progesterone is administered to minimize these effects. Meanwhile, the beneficial effects of HRT are known, there is still concern about its adverse effects such as thromboembolic and cardiovascular effects, increased risk of breast and endometrial cancer. Thus, there is an increasing interest in the development of phytohormonal HRT. The aim of the investigators' study is to evaluate the effects of concentrated extract of soy on hypercoagulation markers in menopausal women.


Eligibility Criteria:
Inclusion Criteria:

* \> 1 year of amenorrhea
* 45 to 65 years old
* without hormone reposition treatment or herbal medications in the 6 months preceding the research

Exclusion Criteria:

* history of thromboembolism
* history of cardiovascular disease
* presence of estrogen dependent neoplasia
* presence of abnormal genital bleeding
* uncontrolled metabolic diseases
* smoking or drinking habits
* use of anticoagulants or acetyl salicylic acid
"Normal Coronary Artery" With Slow Flow Improved by Adenosine Injection, Dipyridamole Treatment and Clinical Follow-up

The investigators will investigate patients undergoing coronary angiography with normal coronary but slow blood flow that was normalized after adenosine injection into the coronary artery. The investigators believe that they have small vessel coronary disease which is the initial presentation of coronary disease prior to anatomical narrowing. To alleviate this phenomenon the investigators intend to examine the long-term clinical response of these patients to treatment with dipyridamole, a well-known medication with almost no side-effects that increases the level of adenosine in the tissue.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing coronary angiography and who have normal coronary artery with slow blood flow that normalized with adenosine injection into the coronary artery

Exclusion Criteria:

* Significant coronary disease
* Unstable patients
* Patients with known sensitivity to dipyridamole
Phenotyping and Genotyping of Duffy Antigen

Malaria remains the world's leading parasitic endemic. Almost half of the world's population lives in endemic areas. Many at-risk people in African countries remain without access to malaria control. Malaria kills approximately 400,000 people each year, most of whom are children under the age of 5 in Africa. Since 2005, an increasing number of Plasmodium vivax infections have been observed in Duffy-negative populations in South America and Africa, calling into question the essential role of the PvDBP-DARC interaction. The objective of the investigators is therefore to study and understand the invasion pathways used by Plasmodium vivax in Duffy-negative subjects.


Eligibility Criteria:
Inclusion Criteria:

* Major subjects
* with malaria and willing to have their blood samples analyzed for this research

Exclusion Criteria:

* Subjects refusing to participate in the study
Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer

RATIONALE: Collecting and storing samples of tissue, blood, and body fluid from patients with cancer to study in the laboratory may help the study of cancer in the future.

PURPOSE: This research study is collecting and storing blood and tissue samples from patients being evaluated for hematologic cancer.

OBJECTIVES:

* Provide source of patient tissue, blood, and body fluid samples for ongoing diagnostic, prognostic, or immune-monitoring studies.
* Support and enhance translational, clinical and basic research for Lineberger Comprehensive Cancer Center (LCCC) members (and non-members who have an LCCC member as sponsor and collaborator) with IRB-approved studies.
* Maintain responsible and appropriate policies and procedures that ensure good patient care and responsible conduct of research.
* Address medical and legal issues, and protect participant and patient privacy and confidentiality.
* Provide a responsible and uniform mechanism for the integrated coordination of the hemato-pathologist and surgeon or hematology/oncology staff, researcher, and protocol office to obtain appropriate specimens for researchers.
* Support young investigators to obtain pilot data for grant funding.

OUTLINE: Patients undergo tissue, blood, and body fluid collection during diagnostic or routine procedures for future correlative studies. Tissue samples may include, but are not limited to, lymph node or non-nodal biopsies, bone marrow biopsy and/or aspirate, blood and serum, and buccal swabs for germline DNA analysis.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of abnormal hematopoietic/lymphoid cancer, including any of the following:

  * Acute myeloid leukemia
  * Acute lymphoblastic leukemia
  * Chronic myelogenous leukemia
  * Chronic lymphoid leukemia
  * Non-Hodgkin lymphoma
  * Hodgkin lymphoma
  * Myelodysplastic syndromes
  * Myeloproliferative disorders
  * Multiple myeloma
  * Waldenstrom macroglobulinemia
  * Aplastic anemia
  * Any other diseases that generate abnormalities in either number, function, or both of any cell type of hematolymphoid lineage
* Patients who are being evaluated at the hematology/oncology clinics of the University of North Carolina Hospitals, at the stem cell transplant clinic, or in the hospital

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Analysis of the Incidence and Risk Factors of Chronic Pain After Cesarean Section

Persistent postoperative pain is a globally recognized issue that deserves attention. Cesarean section is one of the surgeries that may cause persistent postoperative pain. PSPP may affect communication between mother and baby, and may lead to postpartum depression, which has a negative impact on the daily activities and quality of life of mothers. It is an important clinical issue.

The main purpose of this study is to (1) prospectively investigate the overall incidence and characteristics of persistent pain after cesarean section at 3, 6, and 12 months after surgery; (2) Use regression analysis and data modeling analysis to evaluate the relationship between perioperative variables and chronic pain in postpartum women undergoing cesarean section; (3) Analyze the relationship between chronic pain after cesarean section and postpartum depression in postpartum women.


Eligibility Criteria:
Inclusion Criteria:

* Age range from 20 to 50 years old;
* ASA grades I to III;
* Full term pregnancy and planned cesarean section with transverse incision in the lower segment of the uterus;
* Pregnant women who are willing to participate in this study and sign informed consent forms.

Exclusion Criteria:

* Have a history of dementia, mental illness, or any central nervous system disorder;
* Pregnant women who are addicted to alcohol and drugs;
* Difficulty in follow-up or poor patient compliance;
* Has taken other investigational drugs or participated in other clinical trials in the three months prior to being selected for the study;
* Serious complications occur during delivery;
* Unable to cooperate with the research for any reason.
Establish the Couple Intervention Program for Adults With Autism Spectrum Disorder

The development of adult intimate relationships and the transition into couplehood are part of most people's life cycles, but these transitions become very challenging for individuals diagnosed with autism spectrum disorder (ASD) in as much as social interactions, emotional communication, and reciprocity, which are essential for interpersonal relationships, are made more difficult due to the condition itself. In the Adult ASD Clinic of National Taiwan University Hospital, we observe that the wives of the ASD husband suffer from long-term frustration, loneliness and helplessness, and are frequently experience anxiety and depression, that in turns changes the family's function and impacts on children's mental health. To date, there are limited intervention models focusing on couple therapy for ASD adults (or neurodiverse couple). Given the strong needs of clinical service, this study aims to identify the common problems of the ASD couples and develop a program to improve their partner relationships.


Eligibility Criteria:
Inclusion Criteria:

* one person of each couple has either Autism Spectrum Disorder diagnosis or the autism spectrum quotient scoring above or equal to 26
* able to communicate in Chinese
* Wechsler Intelligence scoring above 70

Exclusion Criteria:

* Psychiatric disorder (i.e. schizophrenia, substance abuse)
* unable to communication (i.e. visual or auditory impairment)
Fontan Circulation and Cardiopulmonary Function: Prognostic Factors, Hemodynamics and Long-term Effects

Cross-sectional study of a national cohort of adolescents with univentricular congenital heart defects and Fontan type palliation.

A study group of 40-50 individuals will be investigated by non-invasive and invasive methods, including echocardiography at rest and during exercise, heart catheterization with advanced hemodynamic studies, cardiac and abdominal MRI, abdominal ultrasound and transient elastography, quality of life assessment and cardiopulmonary exercise testing. A selection of tests will be performed in a healthy control group as well.

Eligibility Criteria:
Inclusion Criteria:

* age, heart defect, heart surgery and type of palliation/correction, informed consent

Exclusion Criteria:

* non-consenting, contraindications or increased risk to perform study tests (i.e. metal parts prohibiting MRI, motoric impairment prohibiting CPET)
RT-310 Dose Escalation BPH Study

RT-310, a novel implant, is intended to minimally invasive treat locally the prostate gland for the management of prostate disease, while minimizing side-effects. The objectives of the study are to assess whether RT-310 is safe and feasible for the participant population.

The RT-310 study is a first in human Phase 1 multi-center prospective, non-randomized dose escalation study to evaluate the safety and feasibility of RT-310 for treatment of Benign Prostatic Hyperplasia (BPH). Study participants will have placement of RT-310 and be followed through 180 days.

Eligibility Criteria:
Key Inclusion Criteria:

* Male gender
* Diagnosis of symptomatic BPH
* Age ≥ 50 years up to 80 years
* International Prostate Symptom Score (IPSS) ≥ 13
* Prostate volume 30 to 80 cc per ultrasound
* Inadequate response and/or refusal of medical therapy for LUTS

Key Exclusion Criteria:

* Current urinary retention or at significant risk of urinary retention after drug washout
* Have an obstructive or protruding median lobe of the prostate
* Previous BPH surgical procedure or implants, urethral stricture, Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate
* Previous pelvic surgery or irradiation
* History of neurogenic or atonic bladder
* Stress urinary incontinence, mixed or urge incontinence
* History of prostate or bladder cancer, confirmed or suspected malignancy of prostate or bladder
* History of compromised renal function or upper urinary tract disease
* Other co-morbidities that could impact the study results such as: severe cardiac arrhythmias uncontrolled by medications or pacemaker; congestive heart failure New York Heart Association (NYHA) III or IV; History of uncontrolled diabetes mellitus; significant respiratory disease in which hospitalization may be required
* Known immunosuppression (i.e. AIDS, post-transplant, undergoing chemotherapy)
* No more than two documented active urinary tract infections (UTI) by culture or bacterial prostatitis within last year documented by culture (UTI is defined as \>100,000 colonies per ml urine from midstream clean catch or catheterization specimen)
* Current gross hematuria and/or visible hematuria with participant urine sample without known contributing factor
* Presence of a penile implant or stent(s) in the urethra or prostate
* PSA \> 10 ng/ml unless prostate cancer is ruled out by biopsy. If PSA is \> 4 ng/ml and ≤ 10 ng/ml, prostate cancer must be ruled out to the satisfaction of the investigator via additional tests including digital rectal exam (DRE) and/or biopsy
* Sensitivity to RT-310
* Unable to undergo magnetic resonance imaging (MRI) such as presence of cardiac pacemaker or implanted cardiac defibrillator
* Parkinson's disease or other neurologic disease that may impact bladder function such as stroke, TIA, multiple sclerosis
The Impact of Vitamin D on Disease Activity in Crohn's Disease

The purpose for this study is to determine the effect of vitamin D supplementation on disease activity in Crohn's disease patients in Canada and Saudi Arabia

Hypothesis 1: Patients who are suffering from Crohn's disease are at risk of vitamin D deficiency.

To determine vitamin D status and disease activity in Crohn's disease cases in Canada and Saudi Arabia.

Hypothesis 2: Providing vitamin D in doses higher than RDA (Recommended Dietary Allowance) reduces disease activity in Crohn's disease cases.

To evaluate the impact vitamin D in doses higher than RDA (Recommended Dietary Allowance) on disease activity in Crohn's disease patients.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosis with an active Crohn's disease,
* age above of 16 years

Exclusion Criteria:

* remission or the duration of disease is more than 2 years,
* pregnancy,
* liver or kidney failure,
* inability to take oral supplements or medicine
Monitoring of Adequate Course of General Anesthesia

Clinical monitoring is the most common method of adjustment of the appropriate level of general anesthesia. However, the episodes of intraoperative awareness are still reported, suggesting that clinical observations may not be sufficient in some cases. The objective of the study was to compare the efficacy of clinical and instrumental neuromonitoring with auditory evoked potentials in intraoperative analysis of the proper level of general anesthesia.

The patients scheduled for elective surgery were included into the study, and randomly divided into two groups. Patients in the first group (TIVA group) underwent intravenous, in the second group (VA group) underwent volatile anesthesia. The adequacy of anesthesia was analyzed with standard clinical parameters. All the participants were instrumentally monitored with AAI index. After the anesthesia patients received a questionnaire with the questions regarding possible intraoperative awareness.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for ENT procedures or discectomy,
* preoperative health status I or II according to ASA score.

Exclusion Criteria:

* patients below 18 or above 61 year old,
* ASA status III or higher,
* patients suffering from: (i) hearing problems or tinnitus, (ii) chronic inflammation of the ear, (iii) epilepsy, and (iv) mental disorders,
* pregnancy.
Validation of Useful Markers Generated by Next Generation Bio-data Based Genome Research and Cohort Study

Multiple biomarker development through validation of useful markers generated by next generation bio-data based genome research and cohort study

1. Objectives The study will be performed to develop the integrated analytical methods of genomic data and clinical data and the bio-control network analysis, through which knowledge-based integrated analysis system can be developed and then biomarker for early diagnosis and treatment of pancreatic cancer and bile duct cancer, and finally the customized disease management system. Also, it is to confirm the effectiveness of diagnostic chip for research purpose by applying pancreatic/bile duct cancer-specific biomarker, miRNA, found through the integrated analysis of genomic data and clinical data of patients with pancreatic/bile duct cancer to the blood of patients with pancreatic/bile duct cancer.
2. Effective evaluation method

The discrimination and calibration for algorithm through the diagnostic chip of each cancer type will all be examined using 10-fold cross-validation (100 repetitions). In the 10-fold cross-validation, the data is randomly divided into 10 same sized data, among which 9 are used in making a model for training and the remaining 1 is applied for test, and this process is randomly and independently repeated for 100 times.

The 10-fold cross-validated AUC is calculated to see the discrimination of diagnostic chip of each cancer type, and the 95% confidence interval is presented by non-parametric method.

The 10-fold cross-validated calibration plot is presented to see the calibration of diagnostic chip of each cancer type. The calibration plot visually demonstrate the degree of prediction by comparing the prediction probability of each group and the ratio of actual cancer patients after listing the prediction probability in the order and dividing it with regular intervals.

Then, for the same subjects, the AUC of the CA 19-9, the existing cancer diagnostic tool, is calculated and the 95% confidence interval is presented. To compare the diagnostic chip of each cancer type and the AUC of CA 19-9, p-value is calculated by non-parametric method of 10-fold cross-validated AUC.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically or cytologically diagnosed pancreatic cancer or bile duct cancer
* Patient age: 20\~80 years old
* Patients who voluntarily determined to participate in the clinical trial and signed the informed consent for compliance
* Korean race

Exclusion Criteria:

* Patients with previous history of chemotherapy or radiation therapy for pancreatic cancer and/or bile duct cancer
* Patients who had treatment or surgery for cancer of other organ within 5 years before the clinical trial