cyrilzakka/clinical-trials huggingface dataset:
Ontogeny of Infantile Hemangiomas With Skin Imaging Modalities

A combined set of quantitative skin imaging methods will quantitatively describe the natural ontogeny and the response to standard treatments over time in patients with infantile hemangiomas.

Infantile hemangiomas (IH) are relatively common benign vascular neoplasms, which appear shortly after birth and grow rapidly in the following weeks and months. The proliferative phase involves a rapidly dividing endothelial cell proliferation. The tumors generally stabilize and then involute over time. They are usually clinically insignificant; however, a small percentage of them can be life threatening secondary to location, associated syndrome, and physical findings such as ulceration. Treatment options have included steroids, interferon, vincristine and more recently propranolol. There are few published prospective research studies on the effectiveness of these treatment options. Because of several factors, it has been difficult to objectively measure response of these lesions. The purpose is to determine (1) whether multiple quantitative skin imaging modalities can quantitatively describe the clinically relevant features of infantile hemangiomas, including color (red, blue), lightness, size (height, volume), biomechanical properties, temperature and perfusion and (2) the natural ontogeny and response to treatment over time. The treatments are oral propranolol, topical timolol and untreated (observation).

Eligibility Criteria:
Inclusion Criteria:

* Age ≤ 5 years of age
* Diagnosis of a cutaneous infantile hemangioma
* Diagnosis of hemangioma requiring treatment (treatment includes: propranolol or topical timolol) or diagnosis of an infantile hemangioma that will not be treated at the time of enrollment
* Able to tolerate imaging procedures

Exclusion Criteria:

* Age \> 5 years
* Non cutaneous infantile hemangioma
* Hemangioma on the lip
* Hemangioma on the eyelid
* Hemangioma located in areas whereby measurements cannot be made due to equipment limitations
* Deep hemangioma with no visible skin surface component
* Congenital hemangioma
* No available normal site for study control
* Other vascular anomaly
* Not able to tolerate imaging procedures
Universal- Versus Guidelines-Directed Genetic Testing for Germline Pathogenic Variants Utilizing a Multi-Gene Panel for Inherited Cancers in Non-Western Society.

The investigators aim to study the pattern and frequency of pathogenic variants among ALL newly diagnosed cancer patients in a genetically distinct population.

Additionally, the investigators will study the uptake rate of "cascade family screening", frequency of pathogenic variants and barriers against testing.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient, age ≥ 18 years at time of cancer diagnosis
* Pathology proven diagnosis of cancer; any site, any stage (prior history of cancer is allowed)
* Jordanian nationality
* Willingness to participate
* Signed consent form

Exclusion Criteria:

* Major psychiatric disorder (defined as: patients followed by a psychiatrist and on antipsychotic medications)
* Non-Jordanian
* Patients with Leukemia, Lymphoma and Myeloma
Effect of Dexamethasone and Epinephrine on the Duration of Sciatic Nerve Blocks With Ropivacaine

The aim of the present study is to test that adding dexamethasone or epinephrine significantly prolongs the duration of sciatic nerve blocks with ropivacaine and that the magnitude of the effect differs among dexamethasone and epinehrine.

In a double-blinded trial utilizing single-injection sciatic nerve block, patients are randomly assigned to one of three groups: control: 0.5% ropivacaine adding normal saline; epinephrine: 0.5% ropivacaine adding epinephrine; dexamethasone: 0.5% ropivacaine adding dexamethasone. We assess time to first analgesic request after post-anaesthesia care unit discharge.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status I and II
* patients undergoing elective hallux valgus repair

Exclusion Criteria:

* patients receiving chronic analgesic therapy
* diabetes
* peripheral neuropathies
* psychiatric disorders
* hypersensitivity to amide local anesthetics
* renal disorders
Intake Promoting Effects of Large Portions in Children

The purpose of this study is to test the effects of large food portions on children's eating. Experiment 1 will test the effect of portion size on children's consumption of sweetened beverages; we hypothesize that serving large beverage portions will increase the amount of energy children consume from this food. Experiment 2 will test the effects of portion size on children's intake of fruits and vegetables (FV) affect intake whether such effects are moderated by children's FV preferences and; we hypothesize that serving large fruit and vegetable portions will produce increases in children's intake of these foods, particularly for children who like fruit and vegetables. Experiment 3 will evaluate how food energy density affects children's response to large portions; we hypothesize that large portions will have the greatest influence on children's energy consumption when foods are energy dense. Experiment 4 will begin to address perceptual mechanisms by which large portions affect children's eating.

The emerging epidemic of overweight among underscores the need to identify contributing environmental factors. Marketplace trends for excessive and growing portion sizes in and outside the home have reinforced concerns that large portions may directly contribute by promoting excessive intake. To date, however, systematic investigation of portion size effects on children's eating has been extremely limited. Two laboratory studies have reported that serving large portions of macaroni and cheese to young children promoted energy consumption at meals. Whether portion size effects would be seen with other foods of varying energy content and preference is unknown. Of particular public health interest is whether serving large portions may affect children's intake of sweetened beverages, fruits and vegetables, and energy dense foods. This study will address these questions using an experimental approach to test the effects of portion size on children's eating.

Eligibility Criteria:
Inclusion Criteria:

* 5 to 6 years

Exclusion Criteria:

* severe food allergies
* chronic illnesses or medication use affecting food intake
* dislike of foods on the menu
Improving Patient Motivation and Participation in Rehabilitation Program Through Social Games

This 12-week randomized controlled trial involves two intervention groups (i.e., single-player game group, competition game group) and one control group (i.e., conventional checkerboard group). The main objective of this study is to examine the effects of game-based training on patient motivation, exercise duration, and functional outcomes in comparison with the control group.

A 12-week three-arm randomized controlled trial was conducted to compare the effects between the single-player game, competitive game and a control group (i.e. conventional training) on the motivation, exercise duration and functional improvement in a rehabilitation program. A mix of quantitative method (i.e., questionnaire) and qualitative methods (i.e., interview and observation) were used. The outcome measurements were: (1) motivation: Intrinsic Motivation Inventory (IMI), (2) participation: exercise duration, (3) functional improvement: nine-hole peg test (NHPT) and box and block test (BBT), and (4) user feedback.

Eligibility Criteria:
Inclusion Criteria:

1. Age≥65 years
2. Has neurological disorders (e.g. cerebrovascular accident) with the need of upper limb rehabilitation;
3. Able to stand or sit unsupported for 10 minutes;
4. Discharged from hospital and living in community;
5. Able to communicate either in English or Mandarin; and
6. Able to provide informed written consent.

Exclusion Criteria:

1. Has severe cognitive impairments (Mini-Mental State Examination (MMSE) score \<10),
2. With serious cardiorespiratory conditions,
3. With capacity but do not wish to sign the consent form.
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in IBS

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to IBS.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study

   a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent
2. Male or female of all ages
3. Diagnosis of IBS

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition
ALK33-101: A Study of RDC-0313 (ALKS 33) in Adults With Binge Eating Disorder

The purpose of this study is to evaluate the safety of daily doses of RDC-0313 (ALKS 33) compared with placebo in adults with binge-eating disorder (BED). An additional objective is to explore the efficacy of RDC-0313 treatment in comparison with placebo in adults with binge-eating disorder.

Following screening, eligible subjects will be randomized in a 1:1 ratio to RDC-0313 (ALKS 33) or matching placebo. Once-daily at-home dosing will begin at randomization and will continue for 6 weeks. There will be 8 study visits over a 12-week study period. On an ongoing basis, subjects will complete a take-home binge diary designed to record the number of binge-eating episodes (binge episodes) and binge-eating days (binge days, days during which at least 1 binge occurred), as well as snacks and meals consumed daily over each 7-day period.

Eligibility Criteria:
Inclusion Criteria:

* Meet the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, text revised (DSM-IV-TR) criteria for a diagnosis of binge eating disorder (BED)
* Display greater than or equal to 3 binge eating days per week
* Body mass index (BMI) greater than or equal to 30 kg/m2
* Age of 18 years or older
* Women of childbearing potential must agree to use an approved method of birth control for the duration of the study

Exclusion Criteria:

* Concurrent symptoms of bulimia nervosa or anorexia nervosa
* Suicidal ideation
* DSM-IV-TR diagnosis of substance abuse or dependence (except nicotine or caffeine) within 6 months prior to randomization
* Positive urine toxicological screen for benzodiazepines, opioids, amphetamine/methamphetamine, or cocaine at screening or randomization
* Women who are pregnant or breastfeeding
* Participation in a psychological or weight loss intervention for BED that was initiated within the 3 months prior to screening
* Clinically unstable medical disease
* History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
* History of seizures, including clinically significant febrile seizures in childhood
* Current or anticipated need for prescribed opioid medication during the study period
* Use of any psychotropic medications (other than hypnotics)
* Participation in a clinical trial of a pharmacological agent within 30 days prior to screening
Clinical Study on the Safety and Preliminary Efficacy of hUC-MSCs Intravenous Infusion Therapy for ARDS

The object of this study is to observe the safety of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome, consisting with two phases.

The secondary objectives are to observe the preliminary efficacy of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome. Phase One is an open-label, dose-escalation clinical study. Following safety and tolerability conclusions from Phase One, and upon evaluation and approval by the data safety committee and ethics committee, conduct Phase Two study, which will be a randomized, double-blind, placebo-controlled study. Dosage selection will be based on the safest and most effective dosage determined from Phase One results.

Eligibility Criteria:
Inclusion Criteria:

1. Age greater than 18 years, regardless of gender;
2. Meeting the ARDS Berlin diagnostic criteria;
3. Definite diagnosis within 72 hours;
4. P/F \< 150mmHg;
5. Understanding and signing informed consent.

Exclusion Criteria:

1. Women of childbearing potential with a positive serum pregnancy test before medication, pregnant women, or lactating women;
2. ARDS directly caused by physical or chemical factors;
3. Moderate to severe liver damage (Child-Pugh score \>12);
4. Chronic heart failure, New York Heart Association functional class IV;
5. Severe kidney disease undergoing renal replacement therapy;
6. Severe lung disease, Grade III or IV pulmonary hypertension, receiving oxygen therapy or ventilator support for more than one month in the six months prior to screening, end-stage lung disease, or severe physical limitations due to chest wall deformity;
7. Immunodeficiency, receiving immunosuppressive therapy within 2 weeks (except for low-dose corticosteroids), or with lymphoma, leukemia, or acquired immune deficiency syndrome; history of organ transplantation, bone marrow transplantation, or autologous hematopoietic stem cell suppression;
8. Expected survival time of less than 48 hours due to terminal illness;
9. Patients diagnosed with deep vein thrombosis (DVT) or pulmonary embolism (PE) in the past three months;
10. Patients receiving ECMO therapy;
11. Hepatitis B, hepatitis C, syphilis, or HIV infection.
12. eGFR \< 30ml/min/BSA;
13. ALT \> 5 × ULN;
14. Absolute neutrophil count \< 1500/μL;
15. Subjects who have participated in other clinical studies within the past month (excluding those who have not received intervention), or are currently participating in other experimental treatments;
16. Subjects deemed unlikely to benefit from the study by the investigator, or deemed unsuitable for participation in this study.
Effect of Myofascial Release on Dysphagia in Stroke Survivors

The goal of this clinical trial is to explore Clinical Effect of Myofascial Release Therapy in Dysphagic Stroke Survivors. The main question it aims to answer is:

• Can Myofascial Release Therapy improve swallowing function in Stroke Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Myofascial Release Therapy. The study lasts 21 days for each patient. Researchers will compare the Functional Oral Intake Scale, Penetration-Aspiration Scale, Swallowing Quality of Life to see if the Myofascial Release Therapy can help improve the situation.

Myofascial release, also known as fascial release or fascial manipulation, is a physical therapy used to treat muscle and fascial tissue tension or pain. It involves applying appropriate pressure and stretching to release tight fascia and soft tissues, improving blood circulation, alleviating pain, and promoting rehabilitation.

The goal of this clinical trial is to explore Clinical Effect of Myofascial Release Therapy in Dysphagic Stroke Survivors. The main question it aims to answer is:

• Can Myofascial Release Therapy improve swallowing function in Stroke Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Myofascial Release Therapy. The study lasts 21 days for each patient. Researchers will compare the Functional Oral Intake Scale, Penetration-Aspiration Scale, Swallowing Quality of Life to see if the Myofascial Release Therapy can help improve the situation.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years;
* meeting the diagnostic criteria of stroke;
* any degree of dysphagia at admission;
* steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment.
* transferred out within three weeks of hospitalization in the neurology department.

Exclusion Criteria:

* complicated with other neurological diseases;
* damaged mucosa or incomplete structure in nasopharynx;
* tracheostomy tube plugged;
* unfeasible to Myofascial Release;
* simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.
Role of Lung Ultrasonography in Detecting Extravascular Lung Water in Major Oncosurgeries

During major surgeries optimal intravenous fluid administration is essential , conventional method may cause fluid overload , increased extravascular Lung water can lead to postoperative cardio-respiratory complications , this study was designed to detect immediate postoperative EVLW with Lung Ultrasonography in patients receiving Central venous pressure Guided and Pleth variability Index (PVI) guided fluids intraoperatively .

Standard General Anaesthesia with Endotracheal Tube and Intermittent Positive Pressure Ventilation (IPPV) was given to all patients,Monitoring included 5 lead ECG, Oxygen Saturation (SPO2), End tidal Carbon di oxide (ETCO2), Invasive Blood Pressure (IBP) , Central venous Pressure (CVP), Pleth variability Index (PVI) in study group and Bispectral Index (BIS) , Core temperature .Postintubation before commencement of surgery baseline Lung Ultrasonography will be performed with non-linear probe in 4 zones on Right and Left Lung-- Zone I Right Midclavicular in second intercostal space , Zone II Right Parasternal in third intercostal space, Zone III Anterior axillary line in fourth intercostal space Zone IV Posterior axillary line in the V intercostal space. Zone V to VIII in Corresponding spaces on the Left side . In the control Group CVP Guided IV fluids were given during surgery CVP will be maintained between 10-16 cms H20 , for CVP values \< 10 cms H20 colloid bolus 200ml was given.In the Study Group PVI guided IV Fluids will be given to maintain PVI \<12 for increase in PVI value \> 12 Colloid bolus 200 ml will be given. After the completion of surgery and before extubation Lung Ultrasonography will be performed in all 8 Zones in both lungs to identify B Lines and total number of B lines will be calculated , Extra Vascular Lung Water (EVLW) Grading will be done as B Lines \<5 Mild, between 5-15 moderate , \> 15 severe .Total IV Fluids along with colloid boluses will be calculated , Postintubation as Baseline and after the completion of surgery Arterial blood gas analysis will be done for Alveolar-Arterial Oxygenation Pa02 (A-a) and blood Lactate values . After completion of surgery neuromuscular blockade will be reversed and trachea extubated .

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing major Oncosurgeries under General Anaesthesia

Exclusion Criteria:

* Left ventricular ejection fraction (LVEF )\< 40%
* Chronic Obstructive Pulmonary Disease (COPD)
* BMI \>30
* Lung fibrosis
* Previous lung surgery
Improvement in Wound Healing With Negative Pressure Wound Therapy for Postoperative Total Hip Arthroplasty

For the target population of adult patients following primary total hip arthroplasty, the randomized clinical trial will be used to evaluate the efficacy of the use of a mobile negative pressure wound therapy(NPWT) device compared to a standard absorptive dressing in the immediate postoperative period. We will apply two dressing types and evaluate the postoperative wounds with a wound scoring system (ASEPSIS) that incorporates multiple variables of wound infection risk.


Eligibility Criteria:
Inclusion Criteria:

- Adult patients undergoing primary total hip arthroplasty.

Exclusion Criteria:

* age less than 18 y/o
* Total hip arthroplasty for fracture
* Revision or conversion total hip arthroplasty
* inability to personally consent to participation due to cognitive impairment, intoxication or sedation
* multiple surgical procedures
* Patients taking immune modulating medication(prednisone, methotrexate, anakinra, etc.)
* skin hypersensitivity to acrylic adhesive or silver.
* Inability to care for dressing due to physical or mental incapacitation
Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis

This study evaluated the safety, tolerability and effect on MRI lesion parameters of FTY720 in patients with relapsing multiple sclerosis.


Eligibility Criteria:
Core Study

Inclusion Criteria:

* Diagnosis of relapsing multiple Sclerosis (MS)
* Patients with at least two documented relapses in the previous 2 years or one documented relapse in the last year
* Patients with an Expanded Disability Status Scale (EDSS) score of 0-6

Extension Study

* A positive Gd-enhanced MRI scan at screening (in case the first MRI scan obtained at screening was negative, a second scan could have been obtained 1 month later)
* Neurologically stable with no evidence of relapse within 30 days prior to randomization,or during the Screening and Baseline periods.
* Female patients either post-menopausal, surgically incapable of bearing children, or practicing an acceptable method of birth control. Females of childbearing potential with a negative pregnancy test at baseline prior to entry into the treatment period.

Exclusion Criteria:

Core Study

* Patients with other chronic disease of the immune system, malignancies, pulmonary or heart disease, etc
* Pregnant or nursing women

Extension Study

* Patients who had permanently discontinued study drug prior to the Month 6 visit of the core study
* Patients with diabetes mellitus (to reduce the risk of ME), and therefore ongoing patients with diabetes mellitus or who developed diabetes mellitus were discontinued from the study)

Other protocol-defined inclusion/exclusion criteria may apply
Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With History of Inadequate Response to Oral Preventive Medications

This study is being conducted to evaluate the efficacy and tolerability of rimegepant for migraine prophylaxis in adults with a history of inadequate response to oral preventive medications


Eligibility Criteria:
Inclusion Criteria:

1. Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age.
2. Migraine attacks, on average, lasting about 4 - 72 hours, if untreated.
3. 4 to 14 migraine days per month, on average, across the 3 months prior to the Screening Visit (month is defined as 28-days for the purpose of this protocol).
4. Less than15 headache days (migraine or non-migraine) per month in each of the 3-months prior to the Screening Visit and throughout the Screening Phase.
5. Subjects must be able to distinguish migraine attacks from tension/cluster headaches. Prior inadequate response, within 10 years of the Screening Visit, to agents across 2-4 categories of recognized, orally-administered, migraine-preventive medications where at least one example of prior inadequate response is due to lack of efficacy or prior intolerance (not contraindication).

Exclusion Criteria:

1. History of cluster headaches, basilar migraine (migraine with brainstem aura), or hemiplegic migraine.
2. Current medication overuse headaches.
3. 15 or more headache days (migraine or non-migraine) per month in any of the 3-months prior to the Screening Visit or during the first 28- days of the Observation Phase.
4. Inadequate response (due to lack of efficacy, prior intolerance, or contraindication) to agents across \> 4 categories of recognized, orally administered, migraine-preventive medications.
5. Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex regional pain syndrome \[CRPS\]).
6. Other pain syndromes (including trigeminal neuralgia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, interfere with study assessments of safety or efficacy.