cyrilzakka/clinical-trials huggingface dataset:
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women

The objective of this study is to assess the effects of ergothioneine at two doses, compared to placebo, on cognition, mood, and sleep in healthy adult men and women.

This will be a placebo-controlled, randomized, double-blind, parallel-arm trial. The study will consist of one screening (visit 1a, week 0), one baseline visit (visit 1b, week 0), and three treatment visits (visits 2, 3, and 4; weeks 4, 8, and 16).

Eligibility Criteria:
Inclusion Criteria:

* Individuals 55-79 years of age.
* Body mass index (BMI) 18.50-34.99 kg/m2
* Non-smoker defined as no smoking for at least 6 months.
* Willing to limit alcohol and caffeine consumption
* Generally, in good health based on medical history and laboratory assessments
* Agree to avoid consumption of mushrooms and excluded medications/supplements for the duration of the study
* Willing to commit to all study procedures

Exclusion Criteria:

* Consumption of mushrooms more than once per week
* History or presence of a psychiatric or neurologic disease including, but not limited to, epilepsy, cerebrovascular disturbance, traumatic injury, or clinically diagnosed dementia or Alzheimer's disease.
* Scores ≥17 on the Beck Depression Inventory
* History of cardiovascular complications, type 1 or type 2 diabetes mellitus, uncontrolled hypertension, or any other clinically significant disorder
* History of cancer except non-melanoma skin cancer or carcinoma in situ of the cervix within the past 2 years
* Use of any product containing marijuana (THC) and/or cannabidiol (CBD) including oral consumption, inhalation, \& other
* Any intolerance to any components of the study products
* Exposure to any non-registered drug product within the past 30 days
* History of drug or alcohol abuse
* Considered unfit for any reason as determined by the principal investigator
Intravenous Azithromycin Plus Intravenous Ceftriaxone Followed by Oral Azithromycin With Intravenous Levofloxacin Followed by Oral Levofloxacin for the Treatment of Moderate to Severely Ill Hospitalized Patients With Community Acquired Pneumonia

A trial in which patients over 18 years of age who are hospitalized with community acquired pneumonia and are otherwise eligible for entry into the study are randomly selected to receive one of two treatment regimens. After written informed consent is obtained, patients will receive one of the following two treatment regimens: 1) intravenous administration of azithromycin and ceftriaxone followed by azithromycin tablets, or 2) intravenous administration of levofloxacin followed by levofloxacin tablets. At least four study visits are normally conducted up to approximately one month after starting therapy. The objective of this study is to compare the safety and efficacy of the two treatment regimens.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be 18 years or older.
* Patient must be hospitalized and require intravenous therapy for treatment of pneumonia.
* Patient must have pneumonia as documented by relevant signs and symptoms and a positive chest X-ray.
* Patients cannot have certain underlying diseases or conditions as defined in the study protocol.

Exclusion Criteria:

* Pregnant women, nursing mothers, or women of childbearing potential not practicing adequate contraception.
* Known or suspected hypersensitivity or intolerance to any quinolone, penicillin, cephalosporin, or macrolide antibiotic.
* Treatment with any systemic antibiotic for 24 hours or longer within 72 hours prior to the baseline visit.
* Subjects with clinically significant renal dysfunction.
* Subjects with clinically significant hepatic dysfunction.
* Subjects with clinically significant cardiovascular disorders.
European Paediatric Non-Alcoholic Fatty Liver Disease Registry (EU-PNAFLD)

The EU-PNAFLD (The European Paediatric NALFD Registry) will be a network composed of European centres involved in the care of children with NAFLD, and will include Hepatologists, Endocrinologists, and Scientists, supported by relevant international specialists. This collaboration will build on existing infrastructure (local databases and bio-repositories) and will align with the adult European NAFLD Registry ("EPoS", Elucidating Pathways of Steatohepatitis study) to allow long-term follow-up supported by translational studies. Through an international, well-characterised large-scale cohort, we hope to: facilitate multi-centre clinical trials; extend our understanding of the key disease mechanisms of NAFLD; and establish the natural history of paediatric NAFLD.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis made under 18 years of age.
* Diagnosis of NAFLD spectrum disease (simple steatosis (NAFL), steatosis with abnormal transaminases, NASH ± fibrosis or cirrhosis)
* Diagnosis established by:

  * Radiological evidence of hepatic steatosis (e.g. increased hepatic echogenicity on ultrasound), with
  * Exclusion of secondary causes (negative serological liver screen for HBV/HCV, caeruloplasmin \>0.20g/L, no history of excess alcohol consumption, no evidence of iron overload, and no clinically significant alpha-1 antitrypsin (A1AT) phenotype (i.e. SZ, ZZ, SS), with or without
  * Histology (\>5% steatosis and histology consistent with paediatric NAFLD)

Exclusion Criteria:

* Secondary fatty liver disease (e.g. glycogen storage diseases, Wilson disease, viral hepatitis, drug-related, autoimmune hepatitis, type 1 diabetes mellitus)
* Post-transplant fatty liver
* \>20g/day ethanol intake
Development of Eating Disorders Symptoms Among Children

Randomized Clinical Trial, the research will be composed of two parts in order to examine the research question: a combination of controlled randomized retrospective research and prospective cohort research

Prospective Cohort Research:

The research groups - families coming for treatment in "Active Maccabi" clinics in the Northern Region, Israel. Approximately 30 families.

Retrospective Random Controlled Research

1. The research group - families that have completed an intervention program of "Active Maccabi" Northern Region, Israel,within the past two to three years. The families will be requested to attend a follow-up meeting of all family members in which they will answer questionnaires. Approximately 66 families.
2. The control groups - families who did not participate in the program who have a child between the age 7-14 who has suffered from obesity/weight (over the past 2-3 years), in correlation with the child in the intervention group. Approximately 66 families.

Hypotheses of the research:

1. Status of the weight of the child being treated and of his siblings will be higher than that at the end of the program.
2. Indication of the obesogenic environment of families participating in the program will be lower in comparison with families not participating in the program.
3. The rate of eating disorder symptoms among children who participated in the program will be lower in comparison with those of the obese/overweight child in families who were not the program.
4. The rate of eating disorder symptoms among siblings who participated in the program will be lower than that of siblings in families not in the program.

Duration of the Research -Prospective Cohort Research: 6 months of intervention. 8 months follow-up.

Research Instruments

1. Anthropometric measurements of all children in the family (height, weight and BMI). BMI per centile examinations according to age.
2. An acquaintance questionnaire and demographic details - to be answered by parents
3. A FEAQ_R questionnaire to be answered by the parents (only in the prospective research group). The questionnaire will examine the obesogenic burden in the family. A column will be added for each sibling of relevant age. The questionnaire will be valid in English and Hebrew. The psychometric characteristics of the questionnaire: Alpha cronbach - validity 0.84; Reliability 0.78 Trt
4. Eat-26 (cheat) questionnaire to be answered by the children and their siblings. The questionnaire will examine the risk of developing an eating disorder.

Eligibility Criteria:
Inclusion Criteria:

1. Families who participated in "Active Maccabi
2. Families who signed a consent form
3. Families who attended 80% of the sessions

exclusion criteria:

1. Families who don't fill in questionnaires at all stages of the research
2. Families in which the parents refuse to sign a consent form
3. Families in the control group who receive treatment in more than three sessions by a dietician in the community
Characterization of Airway Mucus in Bronchiectasis Patients and Healthy Controls

Analysis of mucus, mucin and DNA concentration, MUC5B/5AC ratio, rheology, osmotic pressure, cohesion and nucleotides in sputum on 30 individual samples of good quality in healthy individuals and those with bronchiectasis. (60 total)

In this study the investigators will investigate the mucus properties in individuals with idiopathic bronchiectasis and healthy individuals without a history of lung disease. In order to understand how mucus is abnormal in disease conditions, the investigators need to understand the mucus biochemical and biophysical properties in healthy individuals. In this study the investigators will prospectively recruit patients with bronchiectasis and healthy individuals from the community to provide airway sputum samples. In these samples the investigators will measure an array of mucus properties. This will help our understanding of the mucus-obstructive lung diseases and facilitate the development of appropriate and effective disease prevention strategies.

A key question is whether mucus is hyper-concentrated and has abnormal biophysical properties in individuals with mucus-obstructive lung disease. To answer this question, the investigators need to understand the properties of the mucus in individuals with idiopathic bronchiectasis and no history of lung disease. This study will allow us to collect airway mucus (sputum) from individuals with bronchiectasis and healthy individuals with no history of lung disease.

Eligibility Criteria:
Participants who meet all the following criteria are eligible for the study:

* Written informed consent
* Bronchiectasis patients: Available CT of the chest that shows evidence of dilated airways fulfilling radiographic criteria for bronchiectasis in more than one lobe and chronic cough.

Participants who meet any of the following criteria will not be eligible for the study:

* Healthy individuals: A history of lung disease, current asthma symptoms or medication use, premature birth (\<37 week gestation), a history of lung disease of infancy, or neurological or cardiovascular illness, current smoker or a history of smoking tobacco products.
* Bronchiectasis patients: Premature birth (\<37 week gestation), a history of lung disease of infancy, or neurological or cardiovascular illness.
* Younger than 18 years of age
Nodal Staging in Breast Cancer With MRL

The aim of this study is to examine the diagnostic performance of gadofosveset enhanced magnetic resonance imaging lymphography (MRL).

The diagnostic performance of MRL will be determined on the basis of a node-to-node matching of imaged nodes to the definitive histopathology. The pathologic examination of the sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) will be regarded as the golden standard for nodal involvement.


Eligibility Criteria:
Inclusion Criteria:

1. Female patient with histopathologically confirmed breast cancer about to undergo nodal staging.
2. Willing and able to undergo all study procedures
3. Has personally provided written informed consent.

Exclusion Criteria:

1. Age \<18,
2. Pregnancy
3. Contra indications for MRL such as pacemaker, aneurysm clips or severe claustrophobia.
4. Allergy to any of the ingredients of Gadofosveset (Vasovist® /Ablavar®)
5. Being unable to give informed consent in person
6. Acute or chronic severe renal insufficiency (glomerular filtration rate \<45 mL/min/1.73m2)1.
7. Acute renal insufficiency of any severity due to the hepato-renal syndrome.
8. Known (or suspicion of) QT- prolongation
Effects of Whole-body Vibration Training on Body Composition in Adolescents With and Without Down Syndrome

The main aims of the present project include 1) to study the longitudinal effects of whole-body vibratory exercise on bone metabolism in adolescents with and without DS and 2) to evaluate whether a low frequency vibratory training program consisting of 3 sessions per week for 9 months (each vibratory session last approximately 10 minutes and includes 5-6 bouts of 1 min with 1 min rest between bouts) can improve bone development in these populations. Finally, and additional aim of the project is 3) to determine how long these effects may last after the end of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Both groups: Ages 10 - 19.
* Both groups: Parental/guardian permission (informed consent) and if appropriate, child verbal assent.
* Down syndrome group only: Diagnosis of Down syndrome.

Exclusion Criteria:

* Taking medication affecting bone.
* Non-caucasian.
Effects of Levothyroxine on Endothelial Function of Patients With Subclinical Hypothyroidism

Hypothyroidism is risk factor in atherosclerotic cardiovascular diseases, but there is a controversy in effect of subclinical hypothyroidism on cardiovascular diseases. We aim to estimate the relation between subclinical hypothyroidism and endothelial dysfunction and the effects of levothyroxine therapy on it. Patients with confirmed subclinical hypothyroidism by lab results will be randomized to two groups of treatment with one daily dose of 100 mg Levothyroxine or placebo. The flow-mediated dilation and intima media thickness are evaluated before and after the study.


Eligibility Criteria:
Inclusion Criteria:

* age 18 to 65
* confirmed subclinical hypothyroidism

Exclusion Criteria:

* receiving of other treatments for hypothyroidism
* patients with other major medical disorders
* smoking
* hyperlipidemia
* obesity
Impact of Prisma on Donor Site Pain

The purpose of this study is to assess the feasibility of evaluating the use of a composite collagen, silver-oxidized regenerated cellulose matrix compared to the standard of care dressing on donor site pain for patients undergoing split-thickness skin grafting in preparation for a larger study.


Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled to undergo STSG for any reason
* Patient, or designated healthcare proxy, has read and signed the IRB-approved informed consent form.

Exclusion Criteria:

* Active infection or history of radiation to the donor site
* Patient has a known sensitivity to Promogran Prisma™ or silver
* Elevated INR \>3.0
* Insensate at the donor site
* Chronic narcotic use (\>6 months of daily use)
Adapting Lifestyle Offloading for DFUs

The goal of this pilot clinical trial is to develop and test a tailored occupational therapist-led lifestyle-focused intervention to aid patients in improving diabetic foot ulcer care. The main questions it aims to answer are to determine the acceptability and feasibility of taking a tailored lifestyle-focused approach as part of comprehensive diabetic foot ulcer management. Patient participants with DFUs who require offloading treatment will receive the tailored lifestyle-focused self-management intervention.

Diabetic foot ulcers (DFUs) frequently lead to major amputation and mortality. While relieving foot pressure (i.e., offloading) is vital for healing, many patients struggle to adhere to recommended offloading treatments. Participants with DFUs who require offloading treatment will receive the tailored lifestyle-focused self-management intervention. This occupational therapist-led lifestyle-focused intervention will be co-developed with participants, caregivers, family members, and DFU care team members.

Participants with DFUs will be offered lifestyle-based treatment sessions for up to 8 weeks (virtually) with a licensed occupational therapist. Participants will complete pre/post surveys and a subset will take part in an interview to clarify key findings from surveys and obtain patients' perspective of the effectiveness of the intervention. Investigators will also offer focus group interviews to the DFU care team members and occupational therapist to learn their perceptions on the intervention's acceptability, appropriateness, efficiency, and feasibility at the conclusion of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Age 21 years or older
* History of active DFU necessitating offloading
* Capacity to provide informed consent
* Access to telehealth (internet connection and equipment)
* Ability to walk independently or with an assistive device
* Self-reported life expectancy of more than one year

Exclusion Criteria:

* Self-reported deafness or blindness
* history of lower extremity amputation besides toes
Assessing Cirrhosis Quality of Care While Accounting for Cost

The objective of this study is to determine what influences the patient and caregiver perception of care, and if this perception associates with the percentage of and what quality metrics are being met and outcomes. The investigators also plan to capture the cost of providing quality metrics and the cost of monitoring adherence to quality metrics.

This study will be conducted using mixed-methods. The qualitative part will consist of in person, 1:1, open ended in depth interviews using a standard interview guide with probes. The quantitative part will document subjects meeting or not meeting the quality metrics supported by strong evidence, clinical outcomes, and medical bills.

Eligibility Criteria:
Inclusion Criteria:

* primary liver cirrhosis
* receiving care at the study cite
* no evidence of hepatic encephalopathy if the subject is providing consent

Exclusion Criteria:

* no documentation of cirrhosis
* unable to confirm diagnosis of cirrhosis by imaging or pathology
Study of a New Catheter Using Force Sensing Capabilities for the Treatment of Atrial Fibrillation and Ventricular Tachycardia

The purpose of this study is to study the treatment of Atrial Fibrillation and ischemic Ventricular Tachycardia using a RF ablation catheter with contact force sensing capabilities.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic atrial fibrillation or ischemic ventricular tachycardia

Exclusion Criteria:

* Longstanding persistent AF
* Idiopathic VT
* Congestive Heart Failure
Incidence and Risk Factors of Central Line Catheter Related Thrombosis

Central venous catheters are frequently used for monitoring haemodynamic status and rapidly delivering fluid therapy during the peri- and postoperative periods. Indwelling central venous catheters are typically used 7-14 days postoperatively for additional monitoring and treatment, but patients may develop asymptomatic catheter-related thrombosis, leading to life-threatening pulmonary embolism and death. Early detection helps to avoid such complications. This prospective observational study investigated the risk factors associated with catheter-related right internal jugular vein thrombosis in pediatric patients. The study enrolled 80 pediatric patients who were scheduled to receive central venous catheter. To detect thrombus formation, Doppler ultrasound examinations from the thyroid cartilage level to the supraclavicular region were used after CVC placement and on each of the following days until the catheter was removed.


Eligibility Criteria:
Inclusion Criteria:

* pediatric patients who were scheduled to catheterize central venous catheter

Exclusion Criteria:

* patients who had skin infections on the right side of the neck, making them unsuitable for placement of the catheter via the right side of the neck
* patients who had blood coagulation lesions or bleeding tendencies
* patients with thrombocytopenia
* patients with a history of right internal jugular vein thrombosis
* patients who presented right internal jugular vein thrombosis or stenosis on preoperative Doppler ultrasound examination
Mirror-image Study of Paliperidone Palmitate and Risperidone Long-acting Injection

The primary objective of this single-center multi-site retrospective chart review is to determine if paliperidone palmitate and/or risperidone long-acting injection can decrease the number of psychiatric relapses following their initiation in an inpatient acute psychiatric unit compared to oral antipsychotic therapy and determine if one treatment is superior to the other in this regard. This study will utilize a mirror-image design and incorporate up to a 3 years of follow-up following the index admission. Secondary objectives of this study will be to determine the change in hospital resource utilization for psychiatric reasons following treatment initiation, and to determine the difference in time to relapse.


Eligibility Criteria:
Inclusion Criteria:

• Patients who were initiated on either Risperidone long-acting injection or Paliperidone palmitate during an acute psychiatric admission for schizophrenia or other psychotic related disorders.

Exclusion Criteria:

* Patients who had their long-acting injection stopped prior to the discharge date of their index admission.
* Patients who received a long-acting injection in the year prior to the index admission.
* Patients who had a psychiatric admission to a forensic, rehabilitation or high dependency unit during the observation period prior to or following their index admission.
A Clinical Trial to Evaluate the Safety and Efficacy of Rreproxalap in Adults With Dry Eye Disease

A Randomized, Double-Masked, Vehicle-Controlled Crossover Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease


Eligibility Criteria:
Inclusion Criteria:

1. Eighteen (18) to 70 years of age at the time of screening (either gender and any race)
2. Ability to provide written informed consent
3. Reported history of dry eye for at least 6 months prior to screening
4. Reported history of the use of eye drops for dry eye disease between 2 weeks to 6 months prior to screening

Exclusion Criteria:

1. Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), active ocular inflammation, or history of inflammatory disease (that, in the opinion of the Investigator, could interfere with study conduct or assessments) at screening
2. Contact lens use within 7 days of screening or anticipate using contact lenses during the trial
3. Systemic corticosteroid or other immunomodulatory therapy (not including inhaled corticosteroids) within 60 days of screening, or any planned immunomodulatory therapy throughout the study period
4. Women of childbearing potential (WOCBP) who are pregnant and nursing
5. If participant is of childbearing potential (female or male), unwillingness to use an acceptable means of birth control.
6. Known allergy and/or sensitivity to reproxalap or the drug product vehicle
7. A condition that the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the trial
8. Inability or unwillingness to follow instructions, including participation in all study assessments/procedures and visits
Video Assisted Ablation of Pilonidal Sinus

The investigators supposed that the complete video assisted ablation of pilonidal sinus (VAAPS) could be an effective minimally invasive treatment of pilonidal sinus. This new minimally invasive treatment allows the identification of the sinus cavity with its lateral tracks, the destruction and the removal of all infected tissue and the removing of any hair.


Eligibility Criteria:
Inclusion Criteria:

Diagnosis of chronic pilonidal sinus

Exclusion Criteria:

Inability to consent to the study Recurrent pilonidal sinus after an outmidline technique