cyrilzakka/clinical-trials huggingface dataset:
High Intensity Resistance Training and Possible Sarcopenia

Studies conducted so far added the dietary supplements along with resistance training as an intervention, we could not determine whether the observed effects of the intervention were due to the training program and/or dietary supplements.

This study will investigate the effects of high intensity resistance training solely in the possible sarcopenia cases which has not done before, to author's knowledge. Furthermore this study will help clinicians to individualize and optimize the therapy for specific patient subgroups, improve the potential of this therapy to improve human function and well being, facilitate timely interventions in community healthcare and prevention settings, which will contribute to higher awareness of sarcopenia prevention and interventions in diverse health care settings.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female
* Age more than 60 years
* Possible sarcopenia cases as defined by Asian Working Group for Sarcopenia (Handgrip strength: Male less than 26kg and Female less than 18kg, 5 time chair stand test more than/equals to 12 seconds)

Exclusion Criteria:

* Orthopedic surgery in last one year
* Neurological disorders like stroke etc
* History of recent fractures
* Metabolic disorders like DM etc
* Actively involved in exercise programs
* Cognitive impairment that could confound the assessment
* Wheelchair or bed bound individuals
Diagnosis of Cancer Using Breath Samples

The purpose of this study is to collect breath samples from healthy and cancer sick patients. The breath, collected to special bags, will be transferred to laboratories in the Technion and analyzed using an electronic nose system developed in Hossam Haick's labs (Chemical Engineering, Technion). The hypothesis is that based on the analysis of the chemical bio-markers present in the exhaled breath, cancer states can be distinguished from healthy subjects or before and after treatment, allowing a technique for diagnosis of cancer and/or cancer treatment.


Eligibility Criteria:
Inclusion Criteria:

* The cancer is local or homeostatic
* The subject did not undergo surgery for tumor removal, chemotherapy or radiation treatment prior to first sampling
* The subject signed an informed consent form

Exclusion Criteria:

* The subject is addicted to drugs or alcohol
* The subject smoked in the last hour
* There are communication problems with the subject
Efficacy Study of Dialyzed Leukocytes Extracts to Treat Paediatric Moderate Atopic Dermatitis

Patients with atopic dermatitis treated with conventional treatment plus Dialyzed Leukocyte Extracts (DLE-oral Transferon) as adjuvant, have better clinical outcome than patients treated only with conventional treatment.


Eligibility Criteria:
Inclusion Criteria:

* Atopic dermatitis diagnosis by Hanifin and Rajka classification
* Dermatitis severity: Moderate, according with SCORAD index.
* Patients without treatment of topical steroids or immunosuppressants in the last 3 weeks.
* Patients with "informed consent form" signed by both parents, or advisor.
* Patients 7 years old or older whom have signed the assent form

Exclusion Criteria:

* Patient who were treated with topical, or systemic steroids and/or immunosuppressants and they cannot discontinue their treatment.
* Patients who lived far from the hospital and they could not go to the visits.
Pre-marketing Trial to Assess Safety and Efficacy of 'Volumizing Filler Based on Hyaluronic Acid and Recombinant Collagen'

Study to validate the safety and efficacy of the Hyaluronic Acid +Collagen filler 40 patients will undergo through 3 visits one to asses the health and apply the filler one after 4 weeks to check the results one after 16 weeks for the final check and results validation Safety assessed with analysis of the Adverse Events

The patients chosen with facial laxity characteristics, at the first visit will be assessed and will receive the treatment (microinjections) in the cheekbone area, over the lips and in the marionette lines. After 4 weeks the first visit will assess the change of the tissutal structure with non invasive measurements.

Eligibility Criteria:
Inclusion Criteria:

* all sexes
* caucasic
* 18 to 70 years
* non smoker

Exclusion Criteria:

* Pregnancy
* milking
* smoker
* alcohol or drugs abuse
* change of BMI during the study
* previous facial surgery, implants, permanent treatments
* sensitivity to the product
* dermatological difficult frame
* health weakness
* treated with anticoagulants, antihistaminics, corticosteroids, antidepressants and other drugs impacting on the results
Virtual Reality for Tibial Eminence Fractures

Tibial eminence fracture, a bony avulsion of the anterior cruciate ligament (ACL) from its insertion on the intercondylar eminence,1 was first described by Poncet in 1875. 2 Also known as tibial spine fractures, these injuries occur most commonly in skeletally immature patients between the ages of 8 and 14 years


Eligibility Criteria:
Inclusion Criteria:

* age of children from five to nine
* children have fracture in tibial eminence

Exclusion Criteria:

* children have fracture in tibial eminence grade III
Collection of Bone Marrow From Donors Treated With or Without Filgrastim

This randomized clinical trial is studying the side effects of collection of bone marrow from donors treated with or without filgrastim. Giving colony-stimulating factors, such as filgrastim (G-CSF), to donors helps the stem cells move from the bone marrow to the blood so they can be collected and stored.

PRIMARY OBJECTIVES:

I. To evaluate short- and long-term toxicities in bone marrow donors treated with vs without filgrastim before harvest.

II. To compare 10-year mortality and cancer in donors treated with vs without filgrastim.

SECONDARY OBJECTIVES:

I. To correlate the incidence of acute and chronic graft-vs-host disease in the marrow recipients enrolled on COG-ASCT0631 with four parameters assessed in the bone marrow harvests: absolute T-cell numbers, Th1 vs Th2 profile of T-cells, dendritic cell populations, and T-regulatory cell content.

OUTLINE: Donors are randomized to 1 of 2 treatment arms.

ARM I (unstimulated harvest): Donors undergo conventional (i.e., unstimulated) bone marrow harvest on day 0.

ARM II (stimulated harvest): Donors receive filgrastim subcutaneously on days -4 through 0. Donors then undergo bone marrow harvest on day 0.

After completion of study treatment, donors are followed up at 1, 6, and 12 months and then annually for up to 10 years.

Eligibility Criteria:
Inclusion Criteria:

* Appropriately human leukocyte antigen (HLA)-matched (HLA, A, B, DRB1 identical or antigen mismatched \[i.e., 5/6 or 6/6 antigens matched\]) sibling of the bone marrow recipient enrolled on COG-ASCT0631
* Adequate size relative to the recipient (i.e., harvesting the maximum of 20 cc/kg from the donor would result in a bone marrow graft that will provide an adequate cell and volume dose to the recipient, in the opinion of the treating physician)
* Enrolled on the COG Umbrella Long-Term Follow-Up Study COG-ALTE05N1
* Not pregnant or nursing
* No human immunodeficiency virus (HIV) positivity
* No sickle cell trait or sickle cell anemia/disease
* Not at an increased risk from bone marrow donation after filgrastim administration due to a pre-existing medical condition, as determined by an independent physician separate from the research team
* None of the following:

  * Active infection, especially pulmonary
  * Splenomegaly or a history of splenic injury
  * Active or recent pulmonary disease (i.e., pneumonia within the past 4 weeks)
  * A condition that would make the donor unsuitable to donate, as determined by an independent physician separate from the research team
* No autoimmune disease
Dynamic Presentation of Calorie Information

Participants will be asked to select a hypothetical lunch from a menu that features entrees, sides, and drinks. Participants will be able to select a maximum of 1 item from each category. Following this meal selection, participants will complete a short survey about their demographics, their estimates of information about the meal and about recommended eating habits.

The presence or absence of calorie labels on the hypothetical lunch menu will be randomly assigned to participants. Participants will first be randomly assigned to either the numeric label survey or the light label survey, and then within that survey, participants will be randomly assigned to either a control (no label), an item-level label, or an item-level and meal-level label condition.

Participants will select a hypothetical lunch from a menu that features entrees, sides, and drinks. Participants will be able to select a maximum of 1 item from each category. Following this meal selection, participants will complete a short survey about their demographics, their estimates of information about the meal and about recommended eating habits.

Eligibility Criteria:
Inclusion Criteria:

* 18 or older
* US resident

Exclusion Criteria:

* Unable to complete survey on computer
Biomarkers of Developmental Trajectories and Treatment in Autism Spectrum Disorder (ASD)

The study will evaluate the efficacy of a novel intervention implemented in a classroom setting aimed at improving joint attention and joint engagement skills with infants who are at risk of developing an Autism Spectrum Disorder.

The proposed intervention adapts a parent-mediated intervention that successfully improved outcomes in toddlers with autism. The intervention model (a) targets the foundations of social-communication (joint attention, imitation, play), (b) uses naturalistic strategies to increase the rate and complexity of social-communication and (c) includes parents as implementers of the intervention to promote generalization across settings and activities and to ensure maintenance over time.

In addition to testing the primary effects of this early intervention on the developmental outcomes of children with signs of autism, we will examine whether this method is superior to an early intervention focused on global infant development. Because brain development occurs rapidly in infants and toddlers, we will use high density EEG to investigate (1) biomarkers of change in these infants as a result of intervention and (2) biomarkers predicting response to treatment, with focus on the neural correlates of social attention and learning from joint engagement.

Study Aims:

AIM 1: To examine the effects of the experimental intervention (Baby JASPER) on primary (joint attention) and secondary outcomes (receptive language, play, symbol-infused joint engagement and parent use of social communication support strategies).

AIM 2: To examine maintenance and generalization of the effects of the experimental intervention on children and their parents.

AIM 3: To examine electrophysiological biomarkers of change with treatment as well as predictors of social communication outcomes in children after intervention.

AIM 4 (exploratory): To examine the effect of potential child level and parent level moderators on the primary and secondary outcomes of the study across the two conditions.

Eligibility Criteria:
Inclusion Criteria:

* Have elevated scores on the ADOS-Toddler version and clinical concern from professional (Pediatrician, Psychologist, etc). Because of the young age of children, we expect to intervene with children who do not yet have a diagnosis of ASD but may only show some risk by virtue of elevated scores on the ADOS-T.
* Have a parent available for parent-mediated sessions 2 times per week in the classroom
* Do not have seizures
* Do not have associated sensory or physical disorders
* Are not co-morbid with other syndromes or diseases

Exclusion Criteria:

* Other co-morbid syndromes or diseases
* Seizure activity
* Other sensory or physical disorders
Dextrose, Corticosteroids and Surgical Release in Carpal Tunnel Syndrome

The objective of the present study is to compare the effectiveness of 5% dextrose, local corticosteroids injections and surgical release in patients with electrodiagnostically (EDx) mild to moderate carpal tunnel syndrome (CTS). The investigators hypothesize that in patients with mild to moderate CTS (1) local 5% dextrose injections is non-inferior to local corticosteroid injections at 12 months after treatment, and that (2) local 5% dextrose injections are of non-inferior effectiveness compared to surgical release at 6 months.

Surgical release of the carpal ligament is a standard treatment of the median nerve entrapment at the wrist. Local corticosteroid injections are also an established alternative, particularly for EDx mild or moderate CTS, although majority of patients still needs surgical decompression within 1 year. Majority of studies concluded that after more than 6 months of treatment surgical decompression is better than local corticosteroids injections. Furthermore, corticosteroids also have a number of side effects, including crystal induced synovitis, tendon rupture, axon and myelin degeneration, soft tissue atrophy, skin thinning, steroid flare and hot flushes. Therefore, it would be very useful to have an effective alternative substance for injections, without these problems. Perineural injection of dextrose also seems to be a promising treatment for entrapment neuropathies. To date only two studies investigated the effectiveness of 5% dextrose injections in patients with CTS. Authors concluded that this is an effective treatment, that is for patients with mild or moderate CTS even more beneficial than corticosteroid injections at 6 months follow-up. It was suggested that perineural injection of 5% dextrose decreases neurogenic inflammation. As 5% dextrose has osmolarity similar to normal saline, this formulation seems particularly promising. These expectations were supported in studies including animals and humans reporting no harmful effects.

Eligibility Criteria:
Inclusion Criteria (subject diagnosed as CTS if meeting criterion 1 + at least one of criteria 2 or 3):

1. numbness and tingling in at least two out of the first four digits;
2. symptoms exacerbated during the night or in the morning, on holding the objects or repetitive use of the hand;
3. symptoms relieved by shaking the hand or reposition of the arm.

In addition to these clinical criteria for recruitment EDx confirmation will also be needed. Only patients with bilateral EDx mild to moderate CTS will be included.

Exclusion Criteria:

1. polyneuropathy, symptoms of polyneuropathy, and all conditions causing polyneuropathy (e.g., diabetes);
2. multiple mononeuropathy (e.g., hereditary neuropathy with liability to pressure palsies, syndrome Lewis Sumner);
3. motor neuron disorders (e.g., monomelic amyotrophy, amyotrophic lateral sclerosis - ALS);
4. brachial plexopathy;
5. other focal neuropathies affecting upper limbs (e.g., other median neuropathies, ulnar neuropathies, thoracic outlet syndrome); or
6. previous surgery or local injections for CTS.
Patient Perception of Visual Quality and Function

The purpose of this study is to evaluate the visual quality and function of pseudophakic patients.


Eligibility Criteria:
Inclusion Criteria:

* Minimum 22 years of age
* Pseudophakic patients who have been bilaterally implanted with the same type of intraocular lenses in both eyes
* Ability to understand, read and write English to give consent and complete the study questionnaires
* Availability, willingness, and sufficient cognitive awareness to comply with examination procedures and study visits
* Signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
* Other protocol-defined inclusion criteria might apply

Exclusion Criteria:

* Any ocular pathology of clinical significance, as determined by the investigator, that may affect visual outcomes or influence subjective ocular/visual symptoms
* Patient is pregnant or is lactating
* Concurrent participation or participation within 30 days prior in any other clinical trial
* Other protocol-defined exclusion criteria might apply
Chidamide Plus R-CHOP in Newly Diagnosed Double-Expressor Diffuse Large B-Cell Lymphoma With Other Molecular Subtypes

Evaluation of the Safety and Efficacy of CR-CHOP Treatment in Newly Diagnosed Double-Expressor DLBCL with Other Molecular Subtypes

Patients with the Other Molecular Subtype of double-expressor diffuse large B-cell lymphoma (DEL-DLBCL) demonstrate significantly poorer survival outcomes. The DEB trial demonstrated that chidamide combined with R-CHOP significantly improves the complete response (CR) rate in DEL patients and shows a definitive trend toward benefit in event-free survival (EFS). Therefore, we plan to evaluate the efficacy and safety of C-R-CHOP (chidamide plus R-CHOP) in treating DLBCL patients with the DEL Other molecular subtype.

Eligibility Criteria:
Inclusion Criteria:

* Patients must meet all of the following inclusion criteria to be eligible for enrollment:

  1. ≥18 years of age;
  2. Diffuse large B-cell lymphoma diagnosed by pathological diagnosis according to WHO 2016 classification criteria;
  3. Molecular subtyping, determined through high-throughput sequencing of pathological tissue or peripheral blood, is categorized as the "Other" subtype;
  4. Immunohistochemistry revealed overexpression of MYC and BCL2: MYC ≥ 40%, BCL2 ≥ 50%;
  5. Measurable lesions identified on cross-sectional imaging through diagnostic modalities (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) are defined as the presence of at least one two-dimensional lesion with a maximum cross-sectional diameter (GTD) ≥1.5 cm, irrespective of the short-axis diameter;
  6. The Eastern Cooperative Oncology Group (ECOG) performance status score is ≤2；
  7. Adequate hepatic function is defined as: total bilirubin (TBIL) ≤ 3 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 × ULN; alkaline phosphatase (ALP) ≤ 5 × ULN; serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 35 mL/min as calculated by the Cockcroft-Gault formula;
  8. Voluntary participation with willingness to provide the aforementioned treatment data, accompanied by a signed and dated informed consent form.

     Exclusion Criteria:
* Patients who meet any of the following criteria will be excluded from the study：

  1. Currently enrolled in another clinical trial；
  2. Received prior lymphoma treatment with alternative regimens before enrollment;
  3. Presence of concurrent malignant tumors;
  4. Deemed ineligible for participation by the investigator's judgment；
  5. Presence of severe psychiatric or neurological disorders that may impair the ability to provide informed consent and/or affect the reporting or observation of adverse events；
  6. Patients unable to comply with follow-up requirements；
  7. Pregnant or lactating women, and patients of childbearing potential unwilling to use contraception;
  8. Active infection or uncontrolled HBV (HBsAg positive and/or HBcAb positive and HBV DNA positive), HCV positive
Complex Large-bore Radial Percutaneous Coronary Intervention (PCI) Trial

The COLOR trial is a Multicenter Randomized trial. Patients are eligible for study participation when PCI is indicated for complex coronary lesions. If patients comply with inclusion and exclusion and provide written informed consent they will be randomized in a 1:1 fashion between the two study treatments, (7 Fr. radial access with a Glideslender sheath or 7 Fr. femoral access with a standard femoral sheath) , in a 1:1 ratio.

The COLOR trial is a Multicenter Randomized trial. Patients are eligible for study participation when PCI is indicated for complex coronary lesions. If patients comply with inclusion and exclusion and provide written informed consent they will be randomized in a 1:1 fashion between the two study treatments, (7 Fr. radial access with a Glideslender sheath or 7 Fr. femoral access with a standard femoral sheath) , in a 1:1 ratio.

During hospitalization (before discharge) the access site(s) will be checked for bleeding and vascular complications. All access sites should be checked for absent pulsations and hematomas and the size should be defined (length and width, cm) and accompanied complaints. Radial artery occlusion should be checked with the reverse Barbeau test. The femoral access site should be checked for murmurs and absence of pulsations. Ultrasound or Doppler of the access sites should be performed in those patients with suspected radial or femoral occlusion and the presence of other vascular complications, like (pseudo) aneurysms or arteriovenous (AV) fistula within 1 month.

Patient-reported extremity dysfunction will be evaluated at baseline (before the procedure) and 1-month follow-up. Upper extremity function will be evaluated with the Quick Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH) and lower extremity function with Lower Extremity Functional Scale questionnaire (LEFS). The occurrence of Major Adverse Cardiac Events (MACE) will be evaluated at discharge and 1-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Use of 7 Fr guiding catheter is indicated for complex PCI, according to the expertise of the treating physician.
2. Age 18 years or older.

Exclusion Criteria:

1. Inability to obtain informed consent
2. contra-indication for radial or femoral access
3. Cardiogenic shock
4. ST-elevation myocardial infarction
Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (RCC)

This trial has two parts. The purpose of the first part of the trial is to determine the doses of 2 drugs, sunitinib malate and interferon alfa-2b, that can be given safely in combination. This part is currently closed to enrollment.

The purpose of the second part of the trial is to see if sunitinib malate given on a 4/2 schedule (4 weeks on treatment, 2 weeks off treatment cycle) is any better at delaying progression of renal cell cancer than sunitinib malate given on a continuous dosing schedule. The trial will also determine the number of patients whose cancer responds to the treatments, whether life of patients can be extended, what the side effects are of the treatments, how bothersome disease or treatment-related symptoms are to patients, and whether tests can be found that will predict which patients may or may not respond to these treatments in the future.


Eligibility Criteria:
Inclusion Criteria:

* Advanced renal cell carcinoma of clear cell origin or a component of clear cell histology.
* Measurable disease

Exclusion Criteria:

* Prior systemic therapy of any kind for advanced renal cell cancer
* History of brain metastases
* Uncontrolled hypertension
Visceral Stiffness Measurement Using Acoustic Radiation Force Impulse

The acoustic radiation force impulse (ARFI) technology provides real-time measurements of tissue stiffness.

Aim: Using the ARFI ultrasonography, the investigators aims are to complete the correlation and validity studies between visceral ARFI quantification and the referenced Metavir fibrosis scoring and to conduct subsequent innovative studies on liver diseases.

Using ARFI technology, we are establishing a complete hepatic and visceral shear wave spectrum to correspond to the entire METAVIR fibrosis scoring and various functional stratifications.

Eligibility Criteria:
Inclusion Criteria:

* patients with chronic liver diseases who underwent liver biopsy
* patients with pathologically or radiologically proven cirrhosis

Exclusion Criteria:

* Post major abdominal surgery
* After interferon or neucleos(t)ides treatment
* PBC,PSC,WD,AIH,viral coinfections
* Liver abscess
* Exposure to hepatotoxic drugs or chemicals
* Thrombosis of splenic vein, portal veins
* After resection or embolism of the spleen
* Acute or chronic pancreatitis
* Biopsy contraindications (not exclusive)
* ARFI measurements low quality
* Fibrotest contraindications:

Acute hepatitides, Extrahepatic cholestasis, e.g., pancreatic cancer, gallstones, CBD\>0.7cm Severe hemolysis

* Cardiac congestion
* Liver cancer other than HCC
* Treated HCC