cyrilzakka/clinical-trials huggingface dataset:
Exercise and Nutritional Intervention for Deconditioned Older Adults

In this study we will evaluate whether the addition of a formal lower extremity resistance exercise training program and/or a nutritional supplement will improve the functional recovery of older adult veterans participating in a geriatric rehabilitation program for deconditioning. Specifically, subjects admitted to a geriatric inpatient rehabilitation program with a diagnosis of deconditioning will be randomly assigned to one of four groups; 1) Control/standard rehabilitation program, 2) Standard rehabilitation plus resistance exercise twice per week, 3) Standard rehabilitation plus a daily nutritional supplement, 4) Standard rehabilitation plus the resistance exercise and the nutritional supplement. Subjects will participate in each program for 12 weeks. At the beginning and end of the study we will measure lower extremity strength, walking speed, and overall function (using the standardized Functional Independence Measure), and compare the changes in each group.


Eligibility Criteria:
Inclusion Criteria:

* Veteran admitted to GEM rehabilitation unit
* Primary problem: Deconditioning/Generalized Weakness
* Age 65-90
* Self reported ability to report to the CAVHS GRECC twice per week after discharge from the GEM unit.
* Living in the community prior to recent acute care hospitalization
* Decision making capacity to be able to consent to the study as documented in the GEM attending or GEM APN's admission note

Exclusion Criteria:

* Conditions that are exclusionary criteria for GEM admission including the following: direct transfer from any ICU, end-stage chronic medical/surgical disorder with no rehabilitation potential, terminal diagnosis /hospice/respite care, hemodialysis, active radiation therapy. Also, Type I diabetes mellitus
* Any other condition considered exclusionary by the PI / study physician.

Prior to group assignment, subjects will be evaluated for contraindications to exercise training per the American College of Sports Medicine (ACSM)guidelines including the following:

* Myocardial infarction documented in the past 3 months
* Unstable angina (at rest in past 3 months, or increased angina pattern in past month)
* Uncorrected left main coronary obstruction \> 50%;
* Congestive heart failure exacerbation in past 3 months (symptoms at rest or worsening symptoms requiring change in baseline diuretic dose)
* Severe valvular heart disease (aortic or mitral stenosis with valve area \< 1 cm2 , mitral or aortic insufficiency with any degree of LV dysfunction, pulmonary hypertension \[PASP \> 50 mmHg\], or LV enlargement \[LVESD 40 mm, or LVEDD \> 55 mm\])
* Active pericarditis / myocarditis
* Malignant or unstable arrhythmias, third degree AV block without pacemaker
* Elevated resting blood pressure (systolic \> 200 mmHg, diastolic \> 110 mmHg)
* Known large (\> 4 cm) aortic aneurysm
* Known cerebral aneurysm or intracranial bleed in past 1 year
* Terminal cancer
* Acute retinal hemorrhage or ophthalmologic surgery within 3 months
Occupational Therapy Group Program on Falls Prevention and Patient Education for the Older Adults Hospitalized

The primary outcome is to assess the impact of the group program on falls prevention and patient education on home modifications and the implementation of technical assistance.

This study aims to demonstrate that a group program on falls prevention and patient education will improve the acceptance and the implementation of recommendations on technical assistance and home modifications following discharge after an hospitalization for fall.

The secondary outcome will measure the impact of the group program on the incidence of falls, the number of readmissions, fear of another fall and improvement in walking and balance skills.


Eligibility Criteria:
Inclusion Criteria:

* Male/Female over 70 years old living at home and not in a nursing home, hospitalized after a fall or for a falls evaluation.
* Mini mental state examination score over or even 20/30.
* The person is planning to return home after discharge.

Exclusion Criteria:

* Decompensated medical pathologies.
* Severe chronical diseases with symptoms that are not stabilized by medical or non-medical treatments.
* Dizziness/vertigo linked to a vestibular or cerebellar disorder.
* Sensory disability preventing communication and participation in the group.
TeamTRACS Pilot (CTSI)

In a previous research study, the investigators adapted an evidence-based team training intervention for healthcare settings (TeamSTEPPS) to fit the needs and context of Child Advocacy Center multidisciplinary teams. This study is a cluster-randomized controlled trial of the adapted training, TeamTRACS (Team Training in Roles, Awareness, Communication, and Support). This hybrid type 2 effectiveness-implementation study will test the effectiveness of TeamTRACS and pilot a self-guided approach to implementing TeamTRACS in low-resource settings.

This study is designed to test the effects of TeamTRACS on knowledge, skill use, and team functioning. It will also evaluate the acceptability, appropriateness, and feasibility of a self-guided implementation approach that requires few resources and builds local capacity for change. Six rural Child Advocacy Centers (CACs) will be randomized to TeamTRACS (4 CACs) or a waitlist comparison (2 CACs). The long-term goal of this research is to create an effective team training that can be rapidly scaled up and disseminated to rural CACs nationwide. Supporting rural teams can improve team performance, strengthen the workforce, and ultimately improve service quality and outcomes for rural children who experience child abuse.

Eligibility Criteria:
Inclusion Criteria:

* Individuals at least 18 years of age who are members of the multidisciplinary team at the participating CACs.

Exclusion Criteria:

* Under 18 years old
A Structuralised Sick-leave Program Compared to Usual Care Sick Leave Management in Patients After an Acute Myocardial Infarction

In this study the investigators aim at comparing the effect on quality of life and the cost-effectiveness of a structuralised sick-leave program compared to usual care sick leave management in patients after an acute non ST myocardial infarction(NSTEMI).The investigators hypothesize that a structuralised sick-leave program after an acute NSTEMI is cost-effective without a negative effect on quality of life compared to usual care management in this patient group.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute NSTEMI who are revascularized.
* 65 years old or less
* Self caring
* Adequately literate in Norwegian
* Have a regular work in at least 50% position.

Exclusion Criteria:

* Patients not willing to participate
* Professional drivers
* Patients with alcohol or drug abuse
* Severe complications after the myocardial infarction such as malignant arrythmias, heart failure and major bleedings.
* Patients with recent CABG ( coronary artery bypass graft operation) within the last 6 months.
Effects of Neurodynamic Mobilization and Stretching Exercises for Chronic Discogenic Sciatica

This study compares between neurodynamic mobilization and stretching exercises in treatment of chronic dicogenic sciatica

This study was conducted at the outpatient clinics, faculty of physical Therapy, Kafrelsheikh University to compare between the effects of slider, tensioner neurodynamic mobilization techniques and stretching exercises on pain, Range of motion (ROM) and functional disability for patients with chronic discogenic sciatica.

Design of the study:

A pre-test post-test three-armed comparative study design was used for comparison between the effects of slider, tensioner neurodynamic mobilization techniques and stretching exercises for patients with chronic discogenic sciatica.

Selection of patients:

Sample size:

Using G-power software program and regarding F test study , alpha level of 0.05, confidence interval 95% and effect size of 0.25 (to detect small effects ), three groups and 6 dependent variables, the total sample size will be 36 patient (twelve in each group).

To reach the specific sample size, forty-three patients were screened regarding the inclusion/exclusion criteria. Thirty-six patient with unilateral chronic discogenic sciatica from both sexes (....male and ... female) were recruited from the outpatient clinics, faculty of physical Therapy, Kafrelsheikh University. Their age ranged between 21-50 years.

They were randomly allocated by simple random method; to avoid selection bias, patients were asked to choose a card of three wrapped cards representing the three treatment groups:

Group (A): received Slider technique only. Group (B): received Tensioner technique only. Group (C): received Stretching exercises of back extensors, hamstrings and gastrocnemius muscles only.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed by magnetic resonance imaging (MRI) confirming disc lesion.
2. Radicular pain for at least twelve weeks up to one year with no acute episodes for the last four weeks.
3. Positive slump test, with reproduction of neurological symptoms.
4. Ages of 21-50 years of both sexes.
5. Patients with functional disabilities e.g. during lifting or walking

Exclusion Criteria:

1. Patients with sciatica due to other pathologies e.g. lumbar canal stenosis or piriformis syndrome.
2. Patients after any spinal surgery e.g. unilateral hemilaminectomy or microdiscectomy
3. Negative slump test.
4. Progressive neurological symptoms e.g. hyperirritable and unstable symptoms.
5. History of vertebral fracture or trauma.
6. Systemic disorder e.g. diabetes mellitus.
7. Pregnant women.
Biomarker Analysis of Tislelizumab Combined With Chemotherapy for Perioperative Treatment of G/GEJ Adenocarcinoma

G/GEJ adenocarcinoma is one of the most common malignant tumors in China, ranking the fifth highest incidence and third highest mortality worldwide. Currently, surgical resection is the preferred treatment for G/GEJ adenocarcinoma, while the 5-year survival rate of patients is lower than 25%. Compared with surgical resection, immunotherapy is proved to be able to effectively prolong the survival time of patients. On one hand, with the continuous promotion of immunotherapy drugs, the exploration of neoadjuvant application of immunotherapy in G/GEJ adenocarcinoma has become a hotspot in recent years. It's also on their way that clinical trials of programmed death receptor-1 (PD-1), programmed death ligand-1 (PD-L1) and other immune checkpoints are carried out. On the other hand, the research found that although the curative effect of immune therapy seems better, the present G/GEJ adenocarcinoma immunotherapy marker researches mainly focused on the late stage of the cancer, with few studies of immune markers of neoadjuvant therapy for G/GEJ adenocarcinoma. Additionally, it's not quite feasible for single biomarkers to predict the immune treatment effect precisely. Therefore, combined with clinicopathology and therapeutic effects, this study is aimed to construct the efficacy prediction model of anti-PD-1 antibody together with chemotherapy for G/GEJ adenocarcinoma, by detecting RNA expression. Furthermore, this study will perform drug sensitivity test and bio-molecular test on patient derived organoid model to validate the biomarkers found from biological specimens.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-80 (including 18 and 80);
2. G/GEJ adenocarcinoma confirmed by basic ultrasound gastroscopy, enhanced CT (PET/CT), MRI or diagnostic laparoscopy;
3. Biopsy histologically confirmed adenocarcinoma
4. As assessed by the investigator, patients who are qualified for receiving PD-1 mab combined with chemotherapy neoadjuvant therapy;
5. Patients who volunteer to participate in this study and sign the informed consent, with good compliance and cooperation in the acquisition of biological specimens.

Exclusion Criteria:

1. Patients whose biological specimens do not meet the detection standards;
2. In the judgment of the investigator, the patients with factors that might have caused the study to be terminated.
Pilot-testing the Effect of Magnetic Mitohormesis Therapy for Treating Frailty in Older Adults

Thirty (30) adults with limited physical function will be recruited to participate in a double-blind pilot randomized controlled crossover trial in which all participants will receive 12-weeks of twice weekly MMT treatment in the first (Phase 1) or second half (Phase 2) of the study period; during the control period, participants will receive sham treatment and will be blinded to the randomization.


Eligibility Criteria:
Inclusion Criteria:

* physical frailty or pre-frailty, indicated by Short Physical Performance Battery Score \<10;
* intact cognition indicated by a Mini-Cog Screening Test Score \> 2;
* able to read and write in English; and
* access to a telephone.

Exclusion Criteria:

* active malignancy;
* neuro-degenerative disease
* active electronic implants;
* any health conditions that would prevent performing the testing and intervention procedures;
* major surgical procedures within the last 6 months;
* major change in prescription medications within the last 3 months
Interventional Radiology Liver Directed Therapies and Hypofractionated Image-Guided Radiation Therapy in Veteran and Non-Veteran, Non-surgical Hepatocellular Carcinoma Patients

This is a research study to evaluate change in Quality of Life, as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC C-30), from baseline to 1 month post treatment in two patient cohorts receiving Interventional Radiology Liver Directed Therapies or Hypofractionated Image-Guided Radiation Therapy.


Eligibility Criteria:
Inclusion Criteria:

* HCC diagnosed either by histology/pathology or Liver Imaging Reporting and Data System (LIRADs 5 per the ACR's LIRADs criteria 10) by CT or MRI
* Patient is 18 years or older
* ECOG Performance status of 0-2
* Child Pugh score A5, A6, B7 or B8 (see Appendix)
* Lesion ≤ 5cm in size
* ≤ 3 lesions in the liver to be treated on protocol
* Lesion amenable to treatment with both Interventional Radiology Liver Directed Therapies and HIGRT.

Exclusion Criteria:

* Child Pugh score B9 or Class C
* Fluctuating ascites
* Inability to complete baseline Quality of Life survey forms
* Concurrent administration of systemic therapy for hepatocellular carcinoma
* Prior liver radiation therapy is an exclusion unless subject participation is approved by the PI
Gut Hormones and Bone Remodeling in Humans (KS-2)

Effects of GLP-2 and GIP on bone remodeling in healthy young men.

We will investigate acute effects of GLP-2 and GIP on bone remodeling in healthy young men.

Eligibility Criteria:
Inclusion Criteria:

Age between 20 and 40 years old Caucasian Healthy BMI between 18.5 and 24.9 kg/m2.

Exclusion Criteria:

Chronic disease Smoking Medication Weight change more than 3 kg whitin the last 3 months Overweight surgery Intestinal surgery Hgb\<8,0 mmol/L Decreased renal function.
Non-Crossover Study of the LMA Protector Versus Ambu AuraGain

The LMA ProtectorTM is a new extraglottic airway device which brings together features of both the LMA ProSealTM (high seal cuff, gastric access and bite block - to facilitate ventilation, airway protection and airway obstruction, respectively) and the LMA UniqueTM (single use - prevention of disease transmission). In the following randomized study the investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the LMA ProtectorTM and the Ambu AuraGainTM in paralyzed, anesthetized patients.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1 or 2
* Age 19-65 yr
* Written informed consent

Exclusion Criteria:

* Difficult airway
* Non fasted
* BMI \> 35
Reducing Attention Deficit Hyperactivity Disorder in Kindergarten and Pre-Kindergarten Children

This study will determine the effectiveness of an intervention for preventing at-risk kindergarten and pre-kindergarten children from developing attention deficit hyperactivity disorder.

Attention deficit hyperactivity disorder (ADHD) is characterized by inattention, impulsiveness, and hyperactivity. ADHD is not commonly diagnosed until a child has entered formal schooling and shown academic and behavioral adjustment difficulties, but developmental research suggests that risk factors for developing ADHD are evident earlier. A significant number of children start school with high levels of disorganized and inattentive behaviors, which are symptoms of emerging ADHD. This study will test an intervention aimed at preventing the development of ADHD by identifying those at risk for developing ADHD in kindergarten and pre-kindergarten and teaching them self-regulation skills through socialization. These skills have been associated with school success, and they may reduce the likelihood of children developing ADHD.

Participation in this study will last for 4 months, with a follow-up assessment after 1 year. To enroll, child participants will undergo a screening process that will include assessments by their teachers and parents. Eligible child participants will also be assessed by researchers in a classroom setting. They will then be randomly assigned to receive either a play-based intervention, called the Friendship Group, or an individual pre-academic tutoring intervention. Both groups will meet at school. The Friendship Group, which will focus on strengthening attention and self-regulation through social skills, will involve 30 sessions twice a week for 15 weeks. The tutoring intervention, which will focus on strengthening academic skills, will involve one or two sessions a week for 4 months. Participants will be assessed at three time points: pre-intervention, post-intervention, and after 1 year. Assessments will include teacher ratings and direct testing of child attention, language, and pre-academic skills.

Eligibility Criteria:
Inclusion Criteria:

* Clinical or subclinical levels of ADHD symptomatology, based upon teacher and parent report

Exclusion Criteria:

* Presence of sensorimotor disability, frank neurological disorder, or psychosis
* Estimated Full Scale Intelligence Quotient (FSIQ) less than 70
* Very low levels of English proficiency that preclude completion of the assessment battery
* In a temporary custody situation with uncertain outcome
177Lu-DOTA-EB-TATE in Patients With Advanced Neuroendocrine Tumors

This is an open-label, non-controlled, non-randomized study to investigate the long-lasting radiolabeled somatostatin analogue based peptide receptor radionuclide therapy and evaluation safety and dosimetry of 177Lu-DOTA-EB-TATE in patients with advanced metastatic neuroendocrine tumors. A single dose of 0.50GBq-0.70GBq (13.5-18.9 mCi) of 177Lu-DOTA-EB-TATE will be injected intravenously. and monitored at 2, 24, 72,120 and 168 hours post-injection with semiquantitative method based on quantitative single-photon emission computed tomography/computed tomography (SPECT/CT) performance.

Neuroendocrine tumors (NETs) are a heterogeneous group of neoplasms that can develop anywhere in the body and arise from neuroendocrine cells throughout the endocrine system. The most recent NCCN guidelines for unresectable and metastatic NET recommend somatostatin analogues as first-line treatment, but do not recommend a particular treatment sequence for the remaining therapies. Radiolabeled somatostatin analogue therapy, also known as peptide receptor radionuclide therapy has become a well-accepted treatment for patients with well to moderately differentiated unresectable or metastatic NETs and disease progression after first-line treatment. However, a major problem in the therapeutic use of 177Lu-Dotatate has been its short half-life and fast rate of clearance. This study was designed to investigate the safety, dosimetry and preliminary effects of a long-lasting radiolabeled somatostatin analogue 177Lu-DOTA-EB-TATE in patients with advanced metastatic neuroendocrine tumors.

Eligibility Criteria:
Inclusion Criteria:

* Adults who had neuroendocrine tumors and had metastasized, that were with histologically confirmed, inoperable and had showed disease progression according to Response Evaluation Criteria in Solid Tumors \[RECIST\]. Tumors were with well-differentiated histologic features and a Ki67 index of 0 to 20%. Target tumors were selected from CT, MRI, and 68Ga-DOTA-TATE PET/CT, with confirmed somatostatin receptor-expressing and at least one lesion has higher uptake than that of normal liver parenchyma on 68Ga-DOTA-TATE PET imaging within 1 weeks.

Exclusion Criteria:

* The exclusion criteria were a serum creatinine level of more than 150 μmol per liter, baseline measured GFR of less than 50 mL/min/1.73 m2, determined by 99mTc-DTPA renal function examination, a hemoglobin level of less than 8.0 g/dl, a white-cell count of less than 2.0× 109/L, a platelet count of less than 75 × 109/L, a total bilirubin level of more than 3 times the upper limit of the normal range and a serum albumin level of more than 3.0 g per deciliter, cardiac insufficiency including carcinoid heart valve disease, a severe allergy or hypersensitivity to radiographic contrast material, claustrophobia, and pregnancy or breastfeeding.