cyrilzakka/clinical-trials huggingface dataset:
Nonalcoholic Fatty Liver Disease and Atherosclerotic Risk in Children

Nonalcoholic fatty liver disease is a serious health condition in overweight children which can lead to heart disease. This project will examine the links between liver health and cardiovascular risk factors in overweight and obese children, and will test the effect of a long-term after-school exercise program.

Provision of comprehensive evidence for the benefits of exercise on children's health may reduce barriers to vigorous physical activity programs during a childhood obesity epidemic.

This is an ancillary study adding cardiometabolic outcome measures to an ongoing NIH-funded randomized trial of exercise in overweight children ("SMART study," R01 HL087923, P.I. Davis, NCT02227095). This presents the opportunity to obtain detailed measures of liver and vascular health to provide information about the effects of exercise on these conditions.

Eligibility Criteria:
Inclusion Criteria:

* 8-11 years of age
* Overweight or obese (BMI-for-age \>= 85th percentile)
* Able to participate in exercise testing and intervention
* Participating in the SMART Study

Exclusion Criteria:

* Medical condition or medications that would interfere with measurements
* Participation in weight control or formal exercise program outside physical education that meets more than 1 day/week
* T-score \> 75 on the BRIEF Behavior Regulation scale to avoid program disruption
* Unable to complete magnetic resonance imaging.
Treatment of Giardia Lamblia Infections in Children

This study investigates the efficacy and safety of rectally administered metronidazole for pediatric Giardia lamblia infection, as well as the acceptance of this treatment regimen by patients/caregivers. The investigators hypothesize that rectal metronidazole is non-inferior to single-dose of oral tinidazole and will cure at least 72% of patients, a well as will be tolerated as good as tinidazole.

Approximately 180 children (age 6 months to 10 years) whose clinical symptoms could be explained by giardiasis and whose fecal samples will test positive for the presence of G.lamblia in Uusimaa laboratory (HUSLAB) will be recruited.

The study will be performed as an open-label trial. Patients will be randomized during primary visits alternately into two groups by random allocation to receive either of the two study drugs.

Patients from group 1 will be treated with a standard regimen of oral tinidazole (Fasigyn) at a single dose of 50 mg/kg, maximum 2 g/dose. Patients from group 2 will be given rectal metronidazole (Flagyl) 500 mg/dose for children weighing 10-14,9 kg, 1000 mg/dose for those weighing 15-29,9 kg and 1500 mg/dose for those weighing 30-44,9 kg. Suppositories will not be halved. Patients will be given 1 dose/day for 3 days. The first dose of metronidazole will be administered during the primary clinical visit and 2 additional doses will be provided to the parents for home administration.

Fecal samples will be collected from the study patients on day 7-10 post-treatment and will be analyzed in HUSLAB for the presence of G.lamblia antigen by enzyme immunoassay (EIA). Early collection of samples on day 7-10 will help to avoid the risk of tests being positive due to reinfection.

If any of the patients will not clear the infection by day 10, he/she will be invited to a second visit and re-treated. Patients from group 1 will be re-treated by rectal metronidazole and patients from group 2 by oral tinidazole, thus performing a cross-over. Follow-up stool samples will be collected.

Criteria for clinical cure will be resolution of symptoms by day 10 and microbiological cure will be defined as negative G.lamblia antigen test from fecal samples collected on day 7-10 post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* clinical symptoms could be explained by giardiasis AND
* fecal samples will test positive for the presence of G.lamblia in Uusimaa laboratory (HUSLAB)

Exclusion Criteria:

* age \<6 mo or \>10 years
* weight \<9.5 kg
* the absence of symptoms
* co-infection with another pathogen, which may cause giardiasis-like symptoms
Costs and Benefits of ConforMIS iTotal® Knee Replacement System Versus Standard Total Knee

The purpose of this study is to evaluate the costs and benefits of the ConforMIS iTotal® total knee replacement system versus standard total knee arthroplasty.

This study is designed to illustrate the difference in cost between standard total knee replacements and the ConforMIS iTotal at a single institution.

STUDY DESIGN The study is a two-arm single-center, consecutively enrolled retrospective study. Patients enrolled will have previously received either an iTotal CR knee replacement or a standard total knee replacement. The study site will be located in the United States. A minimum of 100 with a maximum of 120 patients will be enrolled in each study arm for a maximum of 200 - 240 patients.

STUDY DURATION This study involves retrospective data collection of operative and peri-operative information to determine the cost impact of several surgical variables. The study will be complete when the retrospective data has been collected on up to 120 patients per arm.

Eligibility Criteria:
Inclusion Criteria:

* Patient has received an iTotal or a standard total knee replacement
* Willingness to participate in the clinical study and to give informed consent, if necessary, as determined during IRB review
* \>18 years of age

Exclusion Criteria:

* Participation in another clinical study that could confound results
* Patient is less than 3 months post-op
ALGRX 4975 in the Treatment of Tennis Elbow

Tennis elbow is a painful condition that results from repetitive arm movement with overuse of muscles, e.g. when playing tennis. A single injection of ALGRX 4975 has the potential to reduce pain for a period of weeks to months. This study will test the efficacy and safety of ALGRX 4975 in the treatment of patients with tennis elbow.

Lateral epicondylitis (tennis elbow) is a painful condition that affects 4 to 7 adults per 1000 annually and tends to involve the subject's dominant side. It typically results from repetitive arm movement with over use of muscles leading to small tears in the tendons attaching muscles of the forearm to the epicondyles that may progress to tendonitis. Pain on or around the lateral epicondyle may radiate down the subject's arm. Gripping or extending the wrist often intensifies the pain.

More than 40 possible treatments have been proposed, reflecting a lack of consensus about optimal management. Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly used to treat tennis elbow, but there are no trials to date that have compared them with other painkillers and one study found no clinically important benefit over placebo. Use of corticosteroid injections provides mixed results in relief of pain and at times insufficient evidence to support their use. Although complications associated with steroid injection are relatively uncommon, when a complication does occur, it can result in severe and disabling consequences for the subject. A small proportion of subjects fail to respond to only one injection of corticosteroid and some subjects who initially improved at four weeks had worse symptoms by six months.

This study has been designed to evaluate the safety and efficacy of a single soft tissue injection of ALGRX 4975 at a dose of 100 µg in comparison to placebo in subjects with acute LE.

Eligibility Criteria:
Inclusion Criteria:

* Acute lateral epicondylitis (LE) of less than 3 months duration (subjects with recurrent acute LE may be included).
* A screening and baseline severity of pain on resisted wrist dorsiflexion score of moderate or greater intensity.
* Lidocaine responsive.
* A systolic and diastolic blood pressure not greater than 140 and 95 mm Hg, respectively.

Exclusion Criteria:

* Any clinically significant form of joint disease, elbow trauma or neuromuscular disorder at the elbow, other than acute LE.
* Physiotherapy treatment within the preceding 2 weeks, prior to Visit 1.
* Any systemic or local corticosteroids within the preceding 3 months, except nasal or inhaled steroids at less than or equal to 1000 mcg/day.
* A medical condition other than LE that requires the use of a pain medication.
* A peripheral sensory or motor neuropathy involving the upper extremities.
Giving Healthy Meal Kits and Cooking Lessons to Rural Families with Food Insecurity.

The goal of this clinical trial is to learn if providing healthy meal kits to food insecure families can help lessen the social and emotional impacts of food insecurity on kids and their caregivers in rural Maine. The main questions it aims to answer are:

1. Is receiving healthy meal kits delivered to homes feasible and acceptable to rural Maine families?
2. Does receiving meal kits (along with an app to help learn how to cook the food) improve food insecurity and diet quality in rural Maine families?
3. Does receiving meal kits (along with an app to help learn how to cook the food) improve family function in rural Maine families? We will look at caregivers' stress, family conflict, household chaos, and child emotional-behavioral symptoms.

Participants will:

1. Recieve and prepare a dietitian-designed meal kit with 10 meals per week for 4 weeks.
2. Receive free culinary medicine education via an app that they will continue to have access to after the study ends.
3. Complete a 1-1.5 hour virtual visit at the beginning of and end of the study.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Legal caregiver for a child between the ages of 6-12 with whom they live at least 75% of the time.
* Reside in rural county in Maine as designated by the Health Resources and Services Administration.
* Endorse food insufficiency within the past month on their screening questionnaire.
* Able to speak and read in English.
* Stable address with the ability to receive packages

Exclusion Criteria:

* Inadequate access (\<5 days/week) to a kitchen with refrigeration and heating elements to prepare meals.
* Food-restrictive diet (i.e., veganism, gluten-free, dialysis-dependent, severe heart failure).
* A household member with any anaphylactic food allergy.
* No access to a smartphone with texting capabilities.
Fluorescence Versus Intraoperative Cholangiography in the Visualization of Biliary Tree Anatomy

The burden of iatrogenic bile duct injury (BDI), the most feared complication of laparoscopic cholecystectomy (LC), is extremely high and the repercussions on the patient's outcomes may be severe ranging from intraoperative repair to liver transplant or patient's death. Different techniques have been proposed to prevent BDI.

Our hypothesis is that a fluorescence-based Imaging would allow visualization of the biliary tree anatomy as good as with the Intraoperative Cholangiogram with several main advantages:

1. ease of use
2. lack of invasiveness
3. absence of ionizing radiation to the patient and the operating staff
4. performed prior to any dissection (prior to "critical view of safety")

Capacity of enhanced-reality based on virtual cholangiography (computer treatment of MRI images) to guide biliary tree anatomy visualization will be also evaluated in this study.

The study requires a 2-month patient participation.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman \> 18 years old
* Symptomatic gallbladder lithiasis or gallbladder polyps
* Clinical, biological ou medical imaging history leading to suspicion of gallstones migration
* Absence of contra-indication to anesthesia and cholecystectomy procedure
* Ability to understand the study related information and to provide written informed consent
* Registered with the French social security regime

Non inclusion Criteria:

* Inability to give informed consent
* Acute Cholecystitis
* Contraindications to MRI exam (claustrophobia, implantable devices)
* Potential risk of allergic reactions to iodine-containing contrast agents, to indocyanine green or other fluorescent compounds
* Pregnancy or breast-feeding
* Exclusion period from other clinical trial
* Forfeit freedom from an administrative or legal obligation
* Under guardianship
Healthcare Decisions Post-Testing, Risk-reducing and Preventative Strategies Using LYNCH Genetic Testing Reducing, and Preventative Strategies Using LYNCH Genetic Testing

Increase surveillance for LYNCH Syndrome

The purpose of this minimal risk, observational survey is to increase surveillance for Lynch Syndrome (hereditary non-polyposis colon cancer), Colorectal, and Endometrial cancer, also to determine targeted risk-reducing and preventative strategies.

Eligibility Criteria:
Inclusion Criteria:

* Must be a Medical Practitioner

  * Medical Doctor (MD)
  * Doctor of Osteopathic (DO)
  * Physician Assistant (PA)
  * Advanced Practice Registered Nurse (APRN)
  * Nurse Practitioner (NP)
* Must have a current standard operating procedure that includes obtaining/reviewing medical history and family medical history.

Exclusion Criteria:

* Government-funded insurance data cannot be included in the study.
Evaluation of the Surfacer System Approach to Central Venous Access

Pre-market Investigational device exemption study evaluating the safety and efficacy of the Surfacer System to facilitate stable upper body central venous access suitable for any conventional catheter.

This prospective, single arm, multi-center study is to demonstrate the safety and efficacy of the Surfacer System. Safety will be evaluated based on the overall rate of acute complications using the study device as compared to historical rates of device/procedure related safety events using conventional central venous access methods. Efficacy will be evaluated by the rate of transient successful central venous accesses created by the study device. A total of 30 patients are planned to be enrolled, with 10 patients initially following review of safety data. Duration expected to be through 7 days. A minimum of 3 sites will participate in the study in the United States.

Eligibility Criteria:
Inclusion Criteria:

* referred for placement of central venous access catheter
* have limited or diminishing upper body venous access
* have pathology impeding standard access methods
* willing to give written informed consent

Exclusion Criteria:

* occlusion of the right femoral vein
* occlusion of the iliac vein
* occlusion of the inferior vena cava
* contraindicated by physician
* acute thrombosis within any vessel planned to be crossed by the Surfacer \*tortuous anatomy which precludes a straight line from femoral vein to subclavian
* diagnosed with active pericarditis
* diagnosed with active endocarditis
* suspected pericardial effusion
* known or suspected aneurysm or ectasia of ascending aorta
* innominate artery or subclavian artery
* pregnant or of childbearing potential not taking adequate contraceptive measures or nursing during study
An Integrated Online Program Using Psychoeducation and Expressive Writing for People With Probable Post-traumatic Stress Disorder and Coexisting Dissociative Symptoms

Objectives:

To evaluate the feasibility, acceptability, safety, and preliminary effects of an integrated online program with psychoeducation and expressive writing components for people with probable post-traumatic stress disorder (PTSD) and coexisting dissociative symptoms.

Hypotheses to be tested:

The program will be feasible, acceptable, and safe to participants. When compared with the waitlist control group, participants in the treatment group will report significantly lower PTSD symptom severity, lower dissociative symptom severity, and greater improvement on coping immediately post-intervention.

Design and subjects:

An assessor-blind, two-arm, randomised waitlist-controlled pilot study is proposed; 90 community adults with significant PTSD and dissociative symptoms will be recruited.

Instruments:

The PTSD Checklist 5, Dissociative Experiences Scale-Taxon, and Brief Coping Orientation to Problems Experienced inventory will be used. Semi-structured interviews will be conducted for process evaluation.

Intervention:

A 10-week integrated online program with psychoeducational and expressive writing components.

Main outcome measures:

The primary outcome is PTSD symptom severity. The secondary outcomes are dissociative symptom severity and coping. The feasibility, acceptability, and safety of the program will also be examined.

Data analysis: Feasibility and acceptability of the program will be assessed by examining the attrition rate, adherence rate, duration of subject recruitment, and post-program individual interviews. Generalised estimating equations with covariate adjustments will be used to examine the preliminary effects of the program.

Expected results:

Adults in the community who experienced significant PTSD and dissociative symptoms will become more resourceful to cope with their traumatic experiences and show more improvements on PTSD and dissociative symptoms.


Eligibility Criteria:
Inclusion Criteria:

(a) be Hong Kong Chinese residents between the ages of 18 and 65; (b) be able to read, write, and speak in Chinese/Cantonese; (c) meet the operational definitions of "probable PTSD" and "coexisting dissociative symptoms" in screening \[score ≥31 on the Chinese version of the PTSD Checklist 5 (PCL-5) and ≥20 on the Chinese version of the Dissociative Experiences Scale-Taxon (DES-T)\]; and (d) have access to a digital device with internet connectivity, such as a smartphone, tablet, or computer.

Exclusion Criteria:

(a) having participated in or currently receiving other psychoeducation/psychotherapies for PTSD or dissociative symptoms; (b) having clinically significant medical conditions that may interfere with safe study participation; (c) concurrent substance dependence, acute suicidality, psychosis, or gross cognitive impairment; and (d) visual, language, or communication difficulties.
Exosome Effect on Prevention of Hairloss

Many people suffer from alopecia, which is caused by hereditary factors, emotional stress, and psychiatric disorders. There are devastating physical and psychological consequences as a result. Exosomes are isolated from donated human amniotic mesenchymal stem cells and purified using specific processing. Exosomes are unique in that they are derived from stem cells and contain a wide range of growth factors. The latest generation of natural products for treating hair loss is exosomes.

Exosomes contain a variety of growth factors that are derived from stem cells. As they are so small, they can be hidden in the bloodstream and carry different types of proteins.

The Wnt-β-catenin pathway is thought to play a major role in the pathogenesis of hair loss. The only FDA-approved medications for the treatment of hair loss are minoxidil (a vasodilator) and finasteride (a selective inhibitor of 5α reductase type II and III isoforms). However, these drugs have not been very perfect. Both have been associated with limited efficacy, duration of effect, and several significant side effects. Regenerative medicine using cell products is looking for a way to heal faster and less cost. Present research focus on Exosome efficacy on hairloss.

Eligibility Criteria:
Inclusion Criteria:

subjects able to read the documents and have medical coverage

Subjects have a "hair loss grade" as below criteria:

1. BASP grade: Basic type (M2 to M3, or C2 to C3, or U1 to U3) or Specific type (V1 to V3, or F1 to F3)
2. For female: Ludwig grade: Ⅰ to Ⅱ
3. For male: Norwood-Hamilton grade: III to IV
4. Hair density by phototrichogram: 60 to 190 hair/cm2
5. Telogen hair ≥ 5% Subject agreeing not to apply any topical treatment Subject agreeing to use a neutral shampoo

Exclusion Criteria:

1. Sick subject in situation of emergency.
2. Subjects who have hereditary history of hairloss
3. Pregnant Females
4. Subject using topic cosmetic treatment or oral nutritional supplement likely to interfere on hair loss parameters during the last 3 months prior to the start of the study (screening)
5. Subjects who have a medical treatment for alopecia or having stopped it from than 3 months
Cardiac Rehabilitation in Cardiomyopathies

This quantitative study aimed to evaluate the respiratory muscle strength, pulmonary function, cardiovascular function, and impact on quality of life in patients after cardiac rehabilitation associated with the diaphragmatic muscle training.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Cardiomyopathies in functional class III or IV (New York Heart Association)
* Aged over 18 years
* Body mass index below 30 kg/m2

Exclusion Criteria:

* Confused and depressed patients
* Cardiac instability and worsening dyspnea after initiation of treatment
Study of VP301 in Patients With Multiple Myeloma, Lymphoma, or Solid Tumors

This study will test the safety, tolerability, and pharmacokinetics of VP301 in patients with relapsed or refractory multiple myeloma, lymphoma, or solid tumors.

This study will test the safety, tolerability, and pharmacokinetics of VP301 in patients with relapsed or refractory multiple myeloma, lymphoma, or solid tumors. This study will be conducted in two parts:

Dose Escalation - This part will evaluate increasing doses of VP301 to identify the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D). The first patient enrolled on the study will receive the lowest dose of VP301. Once this dose is shown to be safe, an additional patient will be enrolled at the next higher dose. Patients will continue to be enrolled into either single or multiple patient groups receiving increasing doses until the MTD or RP2D is reached.

Dose Expansion - Patients with relapsed myeloma and lymphoma will be enrolled and treated with VP301 at the MTD or RP2D.

Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of a refractory solid tumor, refractory myeloma or lymphoma with measurable or evaluable disease
* Patients must have progressed following all therapies of known, potential clinical benefit, or for whom treatments of known clinical benefit are contraindicated.
* Adequate kidney, liver, and hematologic function
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

Exclusion Criteria:

* Active brain metastases and history of leptomeningeal metastases.
* Myeloma patients with plasmacytoma as only measurable disease
* Non-secretory myeloma
* Patients with advanced metastatic, symptomatic, visceral spread who are at risk of life-threatening complications
* Active or chronic, uncontrolled bacterial, viral, or fungal infection(s)
* Abnormal ECG
* Has clinically significant cardiovascular disease
* Additional active malignancy that may confound the assessment of the study endpoints
* Pregnancy or lactation
* Known seropositivity for HIV (human immunodeficiency virus) or active hepatitis B or hepatitis C