cyrilzakka/clinical-trials huggingface dataset:
Role of Multislice CT in Diagnosis of Inflammatory Bowel Disease

Aim of the work: To evaluate the role of CT in diagnosis of IBD

Inflammatory bowel disease (IBD): is a chronic idiopathic disease affecting the gastrointestinal (GI) tract that is comprised of two separate, but related intestinal disorders; Crohn s disease (CD) and ulcerative colitis (UC), IBD is thought to result from an exaggerated and inappropriate immune response to gut luminal microbes in genetically, susceptible individuals who are exposed to environmental risk factors. IBD is most common in North America and western and northern Europe, where incidence rates for UC and CD range from 2.2-24.3 per 100000 person years, It is estimated that more than 1.4 million Americans and as many as 2.5-3 million, Europeans have IBD. While UC and CD share some features, the diseases are distinct. Perhaps the most important differences are that while the chronic inflammation seen in UC is limited to the large intestine and affects only the intestinal mucosa, the inflammation in CD can occur at any location(s) along the GI tract and is often transmural, predisposing patients with CD to the development of penetrating (fistulizing) and fibro stenotic (stricturing) phenotypes that are not typically seen in UC. In some cases, UC and CD are not distinguishable and a diagnosis of IBD unclassified (IBD-U) is made although clinical features of IBD-U tend to mirror those of UC Clinical manifestations of UC include diarrhea, with or without blood, abdominal pain, tenesmus, and fecal urgency, while the manifestations of CD are more variable depending on the extent and location of the GI inflammation. CD with predominantly colonic involvement often presents in similar fashion to UC whereas in small bowel CD, diarrhea and rectal bleeding are seen less frequently and symptoms, fever, fatigue and weight loss are common.

Eligibility Criteria:
Inclusion Criteria:

* Patient in the age group between 15\&40 and another age group between 50\&80 with inflammatory bowel disease.

Exclusion Criteria:

* Patients with any general contraindication to Radiation of CT especially pregnant women.
* Patients with any general contraindication to contrast, impaired renal function \& hypersensitivity.
* Patients of the age group below 15 years old.
Outcome After 24 Months of Participants in the TOBY Xenon Study

The objective of this study is to document the outcome at 2-3 years of age of participants of the TOBY Xe trial, to provide preliminary information about the later clinical effects of treatment with Xenon gas combined with moderate hypothermia following perinatal asphyxia. The TOBY Xe trial was a randomised controlled trial of inhaled xenon gas combined with hypothermia for the treatment of perinatal asphyxia. The trial primary outcome was changes on magnetic resonance parameters examined prior to discharge from hospital.

Continuing clinical follow-up of trial participants is important following any therapeutic trial and is essential in early phase trials where information on the clinical effects of the intervention are lacking. Therefore, we have set up this study to determine the major clinical and neurological outcomes of participants of the TOBY Xe trial and to determine whether the magnetic resonance parameters in that trial are qualified to predict outcome following neural rescue therapy. This information is necessary for planning further studies of this intervention.


Eligibility Criteria:
Inclusion Criteria:

Surviving participants in the TOBY Xenon study

Exclusion Criteria:

Lack of consent to participate
Effects of Synbiotics on Obesity

Synbiotics are a combination of probiotics and prebiotics that can promote the survival of probiotics in the gut. Probiotics utilize prebiotics to produce various metabolites beneficial to human health, such as short-chain fatty acids. The purpose of this trial is to evaluate the impact of a synbiotics product developed by Leewenhoek Laboratories Co., Ltd., on human obesity and its related biomarkers. Participants will be randomly assigned to either the experimental group or the control group in a double-blind trial. The intervention involves the experimental group taking the synbiotics product twice daily, two capsules per dose, after meals for six weeks. The control group will take an equal amount of placebo daily. During the trial, participants' body weight will be recorded weekly, and their body weight, waist circumference, hip circumference, body fat composition, and skeletal muscle mass will be measured before and after the intervention. Additionally, fasting blood samples and blood samples collected at 30, 60, 90, and 120 minutes after consuming the nutritional supplements will be analyzed. The study will compare body fat percentage, body weight, BMI, waist circumference, hip circumference, skeletal muscle mass, and obesity-related biomarkers in blood between the experimental and control groups. The trial results will be used to assess the efficacy of the synbiotics product in improving obesity and its related biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20-60 years.
* Body weight ≥ 50 kg.
* Body Mass Index (BMI) ≥ 24.
* Body fat percentage ≥ 30% for females or ≥ 25% for males.
* Waist circumference ≥ 80 cm for females or ≥ 90 cm for males.
* No remarkable medical history within the past six months.
* Willing to comply with the nutritional instructions during the study period.
* Willing to report body weight once a week.
* Willing to report dietary and activity records.
* Willing to comply with the instruction of "not using" other products containing probiotics or enzymes (excluding yogurt and yogurt drinks).
* Willing to sign Clinical Trial Informed Consent Form before the trial.

Exclusion Criteria:

* Pregnant or breastfeeding.
* Without statutory notifiable diseases, including HIV, syphilis, hepatitis B, hepatitis C, etc.
* Judged by a physician to have "secondary obesity" (obesity caused by endocrine disorders or metabolic abnormalities).
* Presence of endocrine disorders, hypertension, diabetes, cerebrovascular diseases, cardiovascular diseases, liver diseases, kidney diseases, gastrointestinal diseases, or mental disorders.
* Currently taking medications for lipid-lowering, blood sugar control, or weight loss.
* Currently taking antibiotic-related medications.
* Determined unsuitable for participation in this trial by a physician.
A Comparison Between Physical and Virtual Simulation: A Randomized Controlled Trial

Nurse-physician communication skills can be improve through inter-professional team training. Simulation is often used to conduct these training. However, constraints to conduct these sessions such as scheduling and logistic arrangements have been widely reported. Thus with the advancement of technology in education, the use of virtual environment to conduct the team training is being explored and evaluated.

All recruited participants underwent a 3-hour nurse-physician communication training prior to the simulation session. Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) curriculum and pre-learning videos were introduced to the participants. Pre-test questionnaires were administered after the training. Participants were then randomized to the control (live simulation) or intervention group (virtual simulation).

Intervention group participants will undergo a virtual simulation session training via the multi-user virtual world by logging in into the 3D virtual environment while participants in the control group performed the simulations in a physical simulated ward setting. Each pair of 1 medical student and 1 nursing student participate in two role-playing simulation scenarios (15-20 minutes each) along with a facilitator who will provide a debrief (30-minutes). Prior to the simulation, participants were given a smart-watch to monitor their physiological parameters such as heart rate. Post-test questionnaires were administered after the simulation sessions.

After the simulation training, a 30-minutes team-based assessments were conducted based on a inter-professional bedside care scenario in pairs of one medical and one nursing student within their randomized group. The assessments were video recorded for evaluation by assessors who are blinded to the groupings. All participants were then invited to complete a follow-up questionnaire 2 months after the simulation training.

Eligibility Criteria:
Inclusion Criteria:

i) Full time students undertaking National University of Singapore's

* Third or fourth year Bachelor of Science (Nursing)
* Third or fourth year Bachelor of Medicine \& Bachelor of Surgery

ii) Completed acute care management modules

Exclusion Criteria:

i) Does not voluntarily agree to join the study

ii) Does not want their performance to be video-recorded
Safety and Efficacy Study of SHAPE Gel in Alopecia Areata

The purpose of this study is to evaluate the efficacy and safety of SHAPE Gel applied topically to adult patients with alopecia areata of the scalp.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of scalp alopecia areata and scalp hair loss due to alopecia areata for a minimum of six months and a maximum of two years.
* Patients taking thyroid medication or hormonal therapy must be on a stable dose for 6 months and maintain such throughout the study.
* Willingness to maintain same hair style, including shampoo and hair dye, throughout the study period.
* Willingness to have a small micro dot tattoo placed to allow for photographic analysis of treatment and application of study medication.

Exclusion Criteria:

* History of systemic or cutaneous malignancy and/or lymphoproliferative disease, other than patients with: up to 3 basal cell carcinoma; up to three well differentiated cutaneous squamous cell carcinoma; and/or cervical intraepithelial neoplasm (CIN), treated successfully with no evidence of disease, and treated for greater than 6 months prior to study entry.
* Current actinic keratosis on the scalp and/or face
* Nevi or cutaneous lesions thought suspicious for malignancy.
* History of or current gastrointestinal, pulmonary, cardiovascular, genitourinary or hematological disease, CNS disorders, infectious disease or coagulation disorders that would preclude participation in and completion of study assessments.
* Positive for hepatitis B surface antigen, HIV or hepatitis C.
* Co-existent androgenetic alopecia: in males: Norwood-Hamilton stage IV, V or VI; in females: Ludwig stage II or III.
* Unwillingness to discontinue use of non-breathable wigs, weaves or shaving of scalp throughout course of study.
IVIG Trial for the Treatment of Bronchopulmonary Dysplasia

It is intended to examine the efficacy and safety of intravenous immunoglobulin(IVIG) for the bronchopulmonary dysplasia in preterms. Participants will received continuous infusion IVIG 1 g/kg/day for the first 2 days, 0.5 g/kg/day for next 3 days (total does 3.5 g/kg), repeatable 1\~2 times if necessary (5 days after the last infusion).


Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 25 weeks and 31 weeks + 6 days
* Admission within 24 hours after birth.
* Clinical symptoms and chest X-ray results show a highly suspicion of BPD.Clinical symptoms develop in several days or weeks after birth, including respiratory symptoms and signs such as shortness of breath, cyanosis or pulmonary rales, intermittent hypoxic attacks, and chronic oxygen dependence (increased oxygen concentration and assisted ventilation) .One of the following signs present in chest X-ray: lung texture thickening or ground glass opacity in early stage, diffuse lung texture blurred, lung hyperinflation, shadow of linear density increased, and shadow of triangular density increased under the pleura.

Exclusion Criteria:

* Major congenital anomalies(e.g., congenital heart disease, congenital craniocerebral deformity, congenital structural abnormality of respiratory system, congenital hereditary metabolic disease)
* Chromosomal defects (e.g., trisomy 13, 18, 21)
* Severe intracranial hemorrhage
* Multiple organ failure
* Infants who received hydrocortisone or other systemic glucocorticoids for at least 14 cumulative days or within 7 days before trial entry
* With severe lung infections
* Other circumstances that the investigator determines are not suitable for participation in this study
Pain Management for Head and Neck Cancer Survivors

This clinical trial improves an existing pain management program and tests its effect on head and neck cancer survivors. This trial aims to find a better program to improve pain-related physical functioning, mood, and quality of life in a sample of individuals who have undergone treatment for head and neck cancer.

PRIMARY OBJECTIVES:

I. Adapt an existing telehealth pain management intervention to target improvement of pain-related physical functioning, mood, substance use, and quality of life in a local sample of veteran head and neck cancer (HNC) survivors.

II. Conduct a pilot of the adapted intervention to examine the feasibility (accrual, adherence, attrition) and acceptability (participant satisfaction) that will form the basis of a well-powered, randomized clinical trial submitted for funding to the National Institutes of Health (NIH), American Cancer Society (ACS), or Veterans Affairs (VA).

OUTLINE:

Patients attend 5 sessions of Mobile Pain Coping Skills Training for 45 minutes each over 8 weeks.

After completion of study, patients are followed up at 2 months.

Eligibility Criteria:
Inclusion Criteria:

* Clinically confirmed diagnosis of HNC for which the participants have completed curative cancer treatment at the VA hospital or Oregon Health \& Science University (OHSU) within the 3-12 months following treatment
* Self-reported current pain of 4 or higher, using the 0-10 Numeric Pain Rating (NRS) (0="no pain" to 10="the worst pain imaginable")
* Self-report of pain 4 or higher on two occasions, more than three weeks apart, since the completion of curative treatment

Exclusion Criteria:

* Enrolled in hospice
* Have substantial hearing or visual difficulties that would impair ability to participate
* Have inadequate cognitive functioning as indicated by medical record review and/or interactions with clinical staff. If needed the investigators can follow up with the St. Louis University Mental State Examination (score of \< 22/30) (SLUMS); or
* Have untreated severe psychiatric illness that would impact the ability to consent and participate in the intervention
* Had only surgical treatment for their HNC
Pilot Trial of a Behavioral Treatment for Epilepsy

The purpose of this research study is to see if a behavioral program which includes a relaxation technique and lifestyle changes can improve seizure control and well-being in epilepsy patients.

The behavioral treatment approach studied aims to help epilepsy patients discover which circumstances and behaviors trigger their seizures. The most common seizure precipitants are irregularities of sleep, sensory triggers such as flashing lights and emotional stress. Patients will learn how to avoid seizure precipitants and how to stop seizures in their first beginnings. Study participants will continue their prior medications.

Eligibility Criteria:
Inclusion Criteria:

* Age 16-50 years.
* Reliable diagnosis of partial epilepsy, including simple or complex partial or secondarily generalized tonic-clonic seizures.
* Average seizure frequency of at least one partial seizure per month for at least one year.
* Willing not to begin another new treatment other than anticonvulsants (acupuncture, botanicals or other mind-body interventions, ketogenic diet, vagus nerve stimulator, or epilepsy surgery) while enrolled in the study.

Exclusion Criteria:

* Unreliable history of seizure semiology.
* Average seizure frequency less than one seizure per month.
* Patients in whom it is anticipated that current standard of care would mandate a change in their conventional epilepsy treatment during the time period of the study will be excluded.
* Patients taking more than 2 anticonvulsant medications will be excluded.
* Patients with serious other medical problems, such as brain tumors, cancer, stroke, significant heart disease or psychiatric disorders will be excluded.
* Patients with a high likelihood of psychogenic or nonepileptic seizures will be excluded.
* Patients with progressive epilepsy syndromes, neurodegenerative disorders or significant mental retardation will be excluded.
Procalcitonin in Cirrhotic Patients at High Risk for Sepsis

Infections are frequent life-threatening events in patients with cirrhosis, occurring at least in 35% of hospitalized patients and accounting for 20% of inpatients death. Among cirrhotics, ascitic patients have the highest risk of death for sepsis. At the admission, no clear-cut clinical and biochemical features are helpful in diagnosing and prognostically stratifying those patients with sepsis. Procalcitonin (PCT)is a breakthrough marker presenting high sensibility and specificity in diagnosing bacterial infections in different clinical settings. The purpose of this study is to evaluate PCT as a diagnostic and prognostic tool for sepsis in hospitalized cirrhotic patients with ascitic decompensation.


Eligibility Criteria:
Inclusion Criteria:

* liver cirrhosis regardless of aetiology
* clinically relevant ascitic decompensation at time of hospital admission

Exclusion Criteria:

* high haematic ascites
* ongoing antimicrobial therapy or stopped less than 7 days before admission
* last hospital discharge within 7 days
* surgery or trauma within 30 days from enrolment
* hepatocellular carcinoma out of Milan criteria
* extra hepatic malignancies
* immunodeficiency syndrome
* pregnancy
Effects of Functional Electrical Stimulation in Patients Undergoing Coronary Artery Bypass Grafting Surgery

Even with major advances in clinical therapy and percutaneous interventions, coronary artery bypass grafting (CABG) is the most common cardiac surgery performed worldwide and is an effective treatment in reducing symptoms and mortality in patients with coronary artery disease (CAD). However, CABG is a complex procedure that triggers a series of clinical and functional complications, such as series postoperative repercussions as muscle wasting in the first four hours after surgery. For quantification of changes in muscle structure and morphology ultrasonography has been used.

In this context, cardiac rehabilitation program (CRP) is an essential component of care in CABG patients, because this intervention can prevent muscle weakness and wasting. Among different treatment modalities, functional electrical stimulation (FES) is a feasible therapy for neuromuscular activation and prevent muscle weakness and wasting in patients in phase I CRP, however the effect of this intervention in phase II CRP not been fully elucidated. The purpose of this study will to assess the effects of FES plus combined aerobic and resistance training on muscle thickness of quadriceps femoris, lower limbs muscle strength, functional capacity, QoL in in CABG patients enrolled in a phase II CR program.


Eligibility Criteria:
Inclusion Criteria: Patients undergoing CABG up to three weeks before the initiation of the study, a clinical course without complications during hospitalization

* Clinically stable
* The absence of smoking (previous or current).

Exclusion Criteria:

* Unstable angina
* Myocardial infarction and heart surgery up to three months before the survey
* Chronic respiratory diseases
* Hemodynamic instability
* Orthopedic and neurological diseases that may preclude the achievement of the cardiopulmonary test and Cardiac Rehabilitation exercises
* Psychological and/or cognitive impairment that restrict them to respond to questionnaires
* Changes of skin sensitivity,skin lesion and allergic skin problems
* Severe lymphedema
* Uncontrolled diabetes mellitus
* Acute superficial venous thrombophlebitis
* Systemic arterial hypertension
Cardiovascular Effects of Marathon Running

The aim of this study is the investigation of acute cardiovascular responses of marathon runners after the completion of a marathon race (42.2 km), as well as of the determinants of these changes.


Eligibility Criteria:
Inclusion Criteria:

* Marathon runner

Exclusion Criteria:

* Chronic disease, Drugs
Multitarget Strategy for Primary Podocytopathies

The goal of this clinical trial is to verify whether a cell culture system can be used to evaluate the presence of a factor capable of causing proteinuria in the serum of patients with primary podocytopathies. This system will also be used to evaluate the in vitro efficacy of a combined therapy for the treatment of this disorder.

Researchers will compare samples from patients with primary podocytopathies with those obtained from healthy subjects and patients with other renal disorders.

Participants will be asked to visit the clinic at regular intervals for up to 36 months, and to provide blood and urine samples (and a sample of the discarded plasmapheresis effluent in case the procedure is performed).


Eligibility Criteria:
Inclusion Criteria:

* Signature of informed consent for study participation
* One of the following conditions:

  1. Patients with primary podocytopathies (with a histological diagnosis of FSGS or MCD) showing clinical and/or histological evidence of post-transplant recurrence.
  2. Patients with primary podocytopathies (with a histological diagnosis of FSGS or MCD) without clinical and/or histological evidence of post-transplant recurrence.
  3. Patients with primary podocytopathies in their native kidneys in an active clinical phase of the disease.
  4. Patients with podocytopathies presenting clinical features compatible with a secondary form due to another condition.
  5. Patients with glomerulonephritis other than primary podocytopathies (e.g., IgA nephropathy, systemic lupus erythematosus, membranous nephropathy).
  6. Patients with no history of renal diseases

Exclusion Criteria:

* Subjects affected by primary podocytopathies or other glomerulonephritides in clinical remission or with ESRD (eGFR \< 15 ml/min) and/or on renal replacement therapy
* Individuals unable to understand and consent to the study procedures
* Any clinical condition that, according to the investigator's judgment, could compromise patient safety during study participation