cyrilzakka/clinical-trials huggingface dataset:
Lifestyle Intervention in Obese Children Attending Special Primary Education.

The purpose of this study is to assess the prevalence of overweight and obesity in children attending special primary education and to evaluate the effects of a multidisciplinary school-based lifestyle intervention.

Lifestyle changes related to high-fat diets and low levels of physical activity have resulted in a rising prevalence of overweight and obesity in children and adolescents. Ten per cent of the world's school-aged children are estimated to have excess body fat. Overweight and obesity during childhood and adolescence tend to continue into adulthood, increasing the likelihood of a range of impaired health conditions including cardiovascular diseases, diabetes and some cancers. School-based interventions have been proposed to prevent or treat obesity and have been described as a promising approach to reducing obesity among youth. First the extent and the characteristics of the problem have to be assessed for different types of education.

Comparison(s): the prevalence of overweight and obesity in special primary education will be compared to the prevalence in regular primary education. In special primary education, obese and overweight children will be randomised into a experimentel group (6 months of lifestyle intervention including diet and physical activity) and a control group (6 months normal treatment, if any, e.g. exercises for motor skills).

Eligibility Criteria:
Inclusion Criteria:

* children attending special and regular primary education

Exclusion Criteria:

* endocrine conditions affecting bodyweight (e.g. thyroid disease, diabetes)
* mental or physical disabilities that make it impossible to participate in sports activities
Effects of Vitamin B3 Derivative Nicotinamide Riboside (NR) in Bone, Skeletal Muscle and Metabolic Functions in Aging

Researchers are trying to determine if the vitamin B3 derivative Nicotinamide Riboside (NR) has any effects in bone, skeletal muscle, and metabolic functions and structure in aging.

Primary Objective: To assess the effect of "NAD boosting" through NR intake in skeletal muscle and bone metabolism function, and biochemical evidence of improvement of DNA damage repair in healthy elderly female patients with and without exercise.

Secondary Objective: To assess the effect of NR in metabolic functions of glucose and lipid profile as well as to determine the safety of long term administration of NR in healthy elderly female patients with and without exercise.

Eligibility Criteria:
Inclusion Criteria:

* Healthy elderly female subjects between 65 and 80 years of age

Exclusion Criteria:

* General Exclusion Criteria

  * Subjects who participate in regular structured exercise more than 2 hours and 30 min per week or 1hour and 15 min of vigorous exercise per week.
  * Unwilling to comply with the follow-up schedule
  * Inability or refusal to give informed consent by the patient
  * Subject who takes multivitamins containing vitamin B3 derivatives in a dose \> 200 mg/day
  * Participation in another investigational drug study within 1 year of treatment
* Laboratory Exclusion Criteria

  * Serum 25-hydroxyvitamin D \< 15 ng/ml
  * Serum phosphorus \> 5 mg/dL
  * Serum alkaline phosphatase 50% above normal limit
  * Serum aspartate transaminase 50% above normal limit
  * Serum calcium \> 10.5 mg/dL
  * Estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min Creatinine Clearance \< 50%
  * Poorly controlled Diabetes Mellitus (HbA1c\>8)
* Clinical History Exclusion Criteria

  * Confirmed diagnosis of Diabetes Mellitus in use of insulin
  * Subjects presenting systolic BP\>180 mmHg or a diastolic BP\>90 mmHg on initial evaluation
  * Previous diagnosis of liver disease
  * Previous chronic kidney disease stages III and IV
  * Malignancy
  * Malabsorption syndrome
  * Hypo- or Hyperparathyroidism
  * Acromegaly
  * Cushing's syndrome
  * Hypopituitarism
  * Severe chronic obstructive pulmonary disease
  * Congestive heart failure
  * Musculoskeletal disorder
  * History of rheumatoid arthritis
  * Previous gastric bypass surgery
  * Clinical history of osteoporotic fracture (spine, hip, or distal forearm) within past year
  * Extreme of BMI (≤ 18.5 kg/m2 or ≥ 40 kg/m2)
* Medication Exclusion Criteria

  * History of methotrexate therapy
  * History of denosumab therapy
  * History of oral or inhaled corticosteroid use \> 3 months
  * Current use of anticoagulants in general
  * Anticonvulsant therapy (within previous year)
  * Sodium fluoride (any history)
  * Treatment within the past 3 years with bisphosphonates
  * Treatment within the past 3 years with parathyroid hormone
  * Treatment within the past 3 years with calcitonin
  * Treatment within the past 3 years with estrogen
  * Treatment within the past 3 years with selective estrogen receptor modulator
Gravitas Feeding Tube System Placement in Neonates

The purpose of this study is to optimize the Gravitas Feeding Tube System Placement Algorithm for NICU patients and to evaluate the safety and effectiveness of the Gravitas Feeding Tube in the neonate population for the administration of nutrition, fluids and medications.


Eligibility Criteria:
Infants in the Newborn Intensive Care Unit requiring a 5Fr NG tube. The desired size of the feeding tube should be determined clinically, and the Gravitas 5Fr Feeding Tube should only be placed if that size is appropriate.

Inclusion Criteria:

* Age at enrollment: 0 to 18 weeks post-partum. Can be up to 12 weeks preterm (gestational age ≥ 28 weeks).
* Suitable to start enteral feeding
* Anticipated to receive enteral feeding (either bolus or continuous feeds) for more than 6 hours and conclude the enteral nutrition while in the care of the NICU. If enteral nutrition has already been initiated, indicated for replacement of an orogastric/nasogastric feeding tube.

Exclusion Criteria:

* Known major upper airway malformation (e.g. tracheoesophageal fistula)
* Known major GI malformation (e.g. malrotation)
* NPO status -neonate expected to remain NPO for the following 72 hours
* Has a medical condition that drastically affects gastric acid-secretion (e.g. Zollinger-Ellison Syndrome, congenital achlorhydria, gastrointestinal perforation/leak/obstruction)
* Has had removal of part of the stomach
* Critically ill, facing imminent death
* Neonate on ECMO
* Deemed unsuitable for enrollment in study by the site principal investigator based on the patients' medical history
* Ability to have a legally authorized representative provide informed consent

Both neonates on a ventilator (non-invasive or invasive ventilation) or not requiring a ventilator are eligible for this study.
Investigating the Feasibility and Preliminary Effects of Yoga on Excessive Gestational Weight Gain

This study will test the feasibility (i.e., acceptability, demand) of a 12-week prenatal yoga intervention on excessive gestational weight gain (GWG) in pregnant women in the second trimester (enrolled at 12-24 weeks). Participants will be randomized into the prenatal yoga intervention or a pregnancy education (e.g., information on preparing for motherhood, labor and delivery etc.) control group. Participants in both groups will be asked to attend one 75 minute class per week.

The investigators hypothesize that prenatal yoga intervention will be feasible for pregnant women.

The study aims are as follows:

Primary Aim: Determine the feasibility (i.e., acceptability, demand) of a 12-week prenatal yoga intervention in pregnant women. In a randomized controlled pilot study comparing prenatal yoga to a pregnancy education control condition, the investigators will assess 1) acceptability (defined as satisfaction, intent to continue use, perceived appropriateness) and 2) demand (defined as attendance/adherence).

Exploratory Aim 1: Ascertain the preliminary effects of prenatal yoga on excessive GWG \[i.e., weight gain exceeding Institute of Medicine (IOM) recommendations\]. The investigators will compare weight change between intervention and control groups.

Exploratory Aim 2: Explore the potential mediators (i.e., mindfulness, self-regulation) on the effect of prenatal yoga on excessive GWG.


Eligibility Criteria:
Inclusion Criteria:

* Women 18-46 years of age (childbearing age)
* Primiparous (women giving birth for the first time)
* 12-24 weeks gestation at onset of intervention
* Reside in the Phoenix Metropolitan area
* Singleton pregnancy
* English speaking
* Not planning on moving before giving birth
* Can attend at least one session per week

Exclusion Criteria:

* Current alcohol or substance abuse
* Engage in ≥150 min of physical activity
* Participation in ≥30 minutes/week of yoga or contemplative practice (i.e., meditation, qigong) for the previous six months
* Pre-pregnancy BMI ≥40 or \<18.5
* Denial of physical activity participation from a physician (PARmed-X for pregnancy)
Metastatic Breast Cancer-Specific Prognostic Tool

In this qualitative study, Investigators will conduct semi-structured interviews with clinicians that are involved in the care of patients with breast cancer to evaluate the acceptability, appropriateness, and feasibility/usability of a metastatic breast cancer-specific prognostic tool. These interviews will be conducted by the UNC CHAI Core and will continue until thematic saturation (estimated 20-30 participants). The investigators will code the qualitative data using emerging themes, guided by a well-established implementation science theory, the Consolidated Framework for Implementation Research (CFIR). The information gained from these studies will inform an implementation approach to increase the usability and acceptability of a novel prognostic tool to assist oncologists in the prognosis of patients with metastatic breast cancer.

If this study is successful, Investigators will implement an MBC-specific prognostic tool to help clinicians identify patients who are at high risk of death in the next 30 days. Based on the input from clinicians in this proposal, as well as additional qualitative studies with patients and families, Investigators will design an implementation protocol to inform how to use this tool in clinical practice. Rather than simply publishing a prognostic tool that may not be adopted into practice, this project aims to ensure successful implementation of an evidence-based tool into the routine care of patients with MBC. Doing so will serve as an important step towards identifying high-risk patients and connecting ort to ensure high-quality, patient-centered end-of-life care.

Eligibility Criteria:
Inclusion Criteria:

1. In order to participate in this study a subject must meet ALL of the eligibility criteria outlined below.
2. Subjects is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
3. Diagnosis of metastatic breast cancer or primary caregiver for someone with a diagnosis of metastatic breast cancer
4. Age \> 18 years
5. Verbal informed consent obtained to participate in the study.
6. Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.

Exclusion Criteria:

1. Non-English speaking

-
The Effect of Exercise on Neurorecovery Following Mild Traumatic Brain Injury

The study is a "proof-of-principle" project to examine the safety and feasibility of implementing a 1-week aerobic exercise program in the post-acute phase after mild traumatic brain injury (mTBI). The study will define the extent to which the exercise program improves recovery from mTBI in terms of relevant functional outcomes (cognition, mood, and physical status) and biomarkers (peripheral brain-derived neurotrophic factor \[BDNF\] concentration).

This is a "proof-of-principle" project for human subjects to examine the safety and feasibility of implementing a 1-week aerobic exercise program in the post-acute phase after mild traumatic brain injury (mTBI). This study will define the extent to which the exercise program improves recovery from mTBI in terms of relevant functional outcomes (cognition, mood, and physical status) and biomarkers (peripheral brain-derived neurotrophic factor \[BDNF\] concentration). This project will also lay the foundation for understanding the relationship between exercise and BDNF in the area of mTBI neurorecovery, thereby allowing future studies to develop best-practice methods for implementing exercise interventions as a treatment option for brain injuries.

Eligibility Criteria:
Mild traumatic brain injury (mTBI) group:

Inclusion Criteria:

* Meet criteria for mTBI as set forth by the American Congress of Rehabilitation Medicine
* mTBI was sustained 14-25 days before beginning the exercise intervention

Exclusion Criteria:

* comorbid orthopaedic injury that inhibits movement
* history of serious psychiatric disturbance with hospitalization,
* prior history of neurologic disease,
* current or past history of substance abuse disorder,
* diabetes
* previous history of moderate or severe head injury,
* neurological disorder unrelated to TBI (e.g., seizure disorder)
* physician recommendations against exercise
* non-English speakers

Non-injured Group:

Inclusion Criteria:

- Gainesville, Florida community member

Exclusion Criteria:

* History of mTBI or other brain injury in the past year
* comorbid orthopaedic injury that inhibits movement
* history of serious psychiatric disturbance with hospitalization,
* prior history of neurologic disease,
* current or past history of substance abuse disorder,
* diabetes
* previous history of moderate or severe head injury,
* neurological disorder unrelated to TBI (e.g., seizure disorder)
* physician recommendations against exercise
* non-English speakers
COVID-19 and Vaccination Attitudes

The investigators want to study how the exposure to the covid-19 pandemic affects attitudes towards science and vaccination, and how other general attitudes and values are affected.

The investigators will carry out a survey in the UK, asking the same 3 questions on vaccination as in a past survey in late 2019 to the same previous respondents, supplementing this with further questions on covid-19 exposure and attitudes towards, among others, individualism-collectivism, health policy as well as trust in science and institutions.

Eligibility Criteria:
Inclusion Criteria:

* All volunteers who participated in the November 2019 survey on vaccination will be contacted.

Exclusion Criteria:

* People who have not participated in the November 2019 survey
* People unwilling to participate again
Gemcitabine Monotherapy for Metastatic Breast Cancer After Anthracycline and Taxane Regimen

To investigate efficacy, safety and PK of GEM monotherapy after prior chemotherapy with anthracycline and taxane regimen for patients with metastatic breast cancer


Eligibility Criteria:
Inclusion Criteria:

* Histologically and/or cytologically confirmed breast cancer
* Received prior chemotherapy for metastatic breast cancer with anthracycline and taxane regimen
* To have at least one measurable region
* PS: 0-1
* To have adequate organ function (bone marrow, liver and renal function)

Exclusion Criteria:

* To have Interstitial pneumonia or pulmonary fibrosis
* To have inflammatory carcinoma
* Within 28 days after the latest chemotherapy or radiotherapy, 14 days after the latest hormonal/immunotherapy or 7 days after surgery
* To have brain metastasis with symptom
* To have severe complication (cardiac infarction, infection, drug hyper sensitivity or diabetes)
Plasma Amino Acid Levels After Protein Ingestion or Amino Acid Injection During Dialysis

The aim of the study is to compare intradialytic plasma kinetics of amino acids after administration per os of Renoral or intravenous administration of amino acids in patients with end-stage renal disease treated with hemodialysis maintenance.


Eligibility Criteria:
Inclusion Criteria:

* Men and women over 18 (limit included),
* Patients treated with hemodialysis for at least 3 months (limit included),
* Patient with normal albuminemia ≥ 35 g/L
* Patient capable and willing to comply with the protocol and willing to give written informed consent,
* Patient affiliated to a social security scheme.

Exclusion Criteria:

* Patient with a known food allergy or intolerance,
* Patient with alcohol consumption ≥ 20 g/day (equivalent to 2 glasses per day),
* Patient following a specific diet (vegetarian, hypocaloric, restrictive gluten-free diet....) outside the high-protein diet of the patient with terminal renal insufficiency or deviant behavior,
* Pregnant or breastfeeding woman or intending to become pregnant within the next 3 months
* Patient taking vitamin or mineral supplementation for less than one month,
* Patient participating in another clinical study or in a period of exclusion from a previous clinical study;
* Patient refusing to give written consent,
* Patient not able to read and understand information, consent or other study related documents (self-administered questionnaires),
* Patient unable to give informed consent,
* Patient deprived of liberty by administrative or judicial decision, under guardianship or curatorship.
Effect of Dexmedetomidine on Perfusion Index and Microcirculation in Severe Sepsis and Septic Shock Patients

Septic shock is one of the major causes of death worldwide with in-hospital mortality rates varying between (11.9% to 47.2 %). Alterations in microcirculatory blood flow were associated with high risk of organ dysfunction and death. Experimental studies on septic rats revealed that dexmedetomidine treatment can effectively reduce the generation of inflammatory mediators and yields beneficial effects on endotoxemic animals' microcirculation.

Prospective randomized double blinded study. Investigators planned to enroll (40 cases diagnosed with severe sepsis and/or septic shock ) admitted in 50-bed trauma and surgical ICU Cairo University hospital. Demographic data, cause of ICU admission, source of sepsis, APACHE II score, SOFA score 24 hours after admission. Microcirculatory variables (MFI), peripheral perfusion (PI) and metabolic variables will be measured before drugs administrations and at 2, 4, 6, 24 hours thereafter. The total dose of the infused drugs, The requirement of vasopressor will be evaluated as yes/no and total dose of vasopressor will be calculated.

Eligibility Criteria:
Inclusion Criteria:

* Age more than 18 years old
* All mechanically ventilated patients who will be clinically suspected of having severe sepsis/septic shock defined by the criteria of the American College of Chest Physicians/ Society of Critical Care Medicine Consensus Conference

Exclusion Criteria:

* Age \< 18 years old
* Pregnant patient
* Acute hepatitis or severe liver disease (Child-Pugh class C)
* Left ventricular ejection fraction less than 30%
* Heart rate less than 50 beats/min
* Second or third degree heart block
* Systolic pressure \< 90 mmHg despite of infusion of 2 vasopressors
Safety and Efficacy Study of Mix Vaccine in Prostate Carcinoma Patient

The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV). Enrolled patients will receive standard treatment according to National Comprehensive Cancer Network (NCCN) guide line with or without combining MV injection. The efficacy and side effect will be compared between the two groups.

In the study, after evaluation of the general and physical status, eligible patients will be enrolled and randomly assigned into two arms at an 1:1 ratio. In the control arm patients will be receiving standard therapy according to National Comprehensive Cancer Network (NCCN) guide line (control group) and in experimental arm, patients will be receiving simultaneous standard therapy and injection of mix vaccine (MV). MV will be injected weekly till disease progression.

Blood sample will be obtained at baseline and every week before MV injection for the assessment of clinical hematology, biochemistry measurements and immunology index (including immunoglobin, interleukin and interferon). Patients will be evaluated for toxicity throughout the study. Side effect, progression free survival, immunology index and general status will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with prostate carcinoma based on histology
* Evaluable lesions on imaging study
* Without known immunodeficiency
* Age \>18 and \<80 years ago

Exclusion Criteria:

* Patients is unable or unwilling to sign informed consent
* Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication
* Positive HIV and/or RPR (rapid plasma reagin)
* Female patient who is pregnant or breast feeding
* Patients, based on the opinion pf the investigator, should not be enrolled into this study
* Prior anti-cancer vaccine or biological immunotherapy
* Allergic to any known ingredient of the MV compound
Clinical Study of MAK Immune Cells in the Treatment of PHC

The investigators will plan to recruit 20 patients with liver cancer CNLC stage Ⅲa and Ⅲb who are older than 18 years old. Peripheral blood mononuclear cells were obtained and then the MAK(Mixed-activated Killer) cells were injected, and then the safety and efficacy were observed.

The investigators will plan to recruit 20 patients with liver cancer CNLC stage Ⅲa and Ⅲb who are older than 18 years old. Peripheral venous blood was collected twice (50-60ml/time, 2 times, 1 week apart) from each patient. Peripheral blood mononuclear cells were separated, induced, expanded, and cultured in vitro for a total of 1 week to obtain physiological conditions Immune cell populations with tumor-killing activity (mainly MAK immune cells mainly CD3-CD16 + CD56 + and CD3 + CD56 +), and then the MAK(Mixed-activated Killer) cells were injected intravenously for three days. Observe that the patient received cell therapy 24h, The safety and efficacy of 1 month, 2 months, and 3 months, and monitoring of adverse reactions.

Eligibility Criteria:
Inclusion Criteria:

1. Age over 18 years old, regardless of gender.
2. Patients with primary hepatocellular carcinoma.
3. According to the "Regulations for Diagnosis and Treatment of Primary Liver Cancer (2019 Edition)" by the Health Commission of the People's Republic of China Liver cancer staging scheme, patients with Ⅲa and Ⅲb.
4. The expected survival time is ≥6 months.
5. Peripheral blood white blood cell count ≥3×10\^9 /L.
6. Understand and voluntarily sign the informed consent form.

Exclusion Criteria:

1. Patients with immunodeficiency or autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus, multiple Primary sclerosis, insulin dependent diabetes, etc.).
2. Patients with a history of other malignant tumors in the past 5 years.
3. Patients who participated in other clinical trials or clinical research treatments within 3 months before this clinical study By.
4. Patients who have received other cell therapy within the past 6 months.
5. Patients with fever who have not effectively controlled the infection.
6. Patients with high allergies or a history of severe allergies.
7. Patients who are allergic to albumin.
8. Patients after organ transplantation; patients who have been using or are using immunosuppressive agents for a long time.