cyrilzakka/clinical-trials huggingface dataset:
Effect of Fermented Oyster Extract on Musculoskeletal Biomarkers in Relative Sarcopenia Adults

The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of the fermented oyster extract on muscle strength, muscle mass, and muscle function in healthy adults for 12 weeks.

Previous studies have indicated that fermented oyster extract may have the ability to prevent skeletal muscle atrophy. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of the fermented oyster extract on muscle strength, muscle mass, and muscle function in healthy adults; the safety of the compound are also evaluate. The Investigators examine the peak torque/body weight at 60°/s knee extension, handgrip strength, skeletal muscle mass, physical performance, and metabolic parameters at baseline, as well as after 4 and 12 weeks of intervention. Fifty-four healthy adults were administered either 1,200 mg of fermented oyster extract or a placebo each day for 12 weeks;

Eligibility Criteria:
Inclusion Criteria:

* \<110% of the standard lean body mass as measured using the body composition analyzer
* Body-mass index (BMI) ranging from 18.5 to 30.0 kg/m2

Exclusion Criteria:

* Abnormal liver or renal function (i.e., serum aminotransferase activity \> 60 IU/L and serum creatinine concentrations \> 1.2 mg/dL)
* Diabetes (diagnosed clinically or fasting glucose level \> 126 mg/dL)
* History of fracture during the previous year
* Uncontrolled hypertension
* History of serious cardiac disease such as angina or myocardial infarction
* History of gastrectomy
* History of medication for psychiatric disease
* Administration of oriental medicine including herbs within the past 4 weeks Evidence of relatively high skeletal mass (more than 110% of the standard lean body mass as measured using the body composition analyzer
Assessment of Whole Body Cryotherapy in Treatment of Active Axial Spondylarthritis

Whole body cryotherpy (WBC) is a well-tolerated procedure that implies patients' exposition at a temperature of approximately -110 degrees.

A considerable increase in the popularity of WBC has occurred in rheumatologic patients, despite a lack of evidences of its efficiency.

Because of its interesting anti-inflammatory properties, the investigators think that WBC could be an alternative treatment to classical NSAIDs (Non Steroidal Anti Inflammatory Drugs) and corticosteroids, in patients suffering from axial spondyloarthritis.

This is a proof of concept study.


Eligibility Criteria:
Inclusion Criteria:

* patients suffering from axial spondyloarthritis diagnosed according to ASAS criteria, with sacroiliitis on X-rays or MRI, with active disease (BASDAI \> 4/10) despite a stable treatment will be included.

Exclusion Criteria:

* contra indication to cooling,
* previous WBC treatment,
* no social security cover
Pre-Exposure Prophylaxis (PrEP) Provision for Ugandan Fisherfolk

This study is a pilot test of enhancements to the standard of care for providing PrEP in Ugandan fishing communities. The specific aims are to conduct a mixed-methods study assessing enhancements to the standard of care for providing PrEP in fisherfolk communities in Lake Victoria, Uganda.

The study will take place at two landing sites at which PrEP is provided to fisherfolk through the Ugandan national PrEP program. The comparison site will receive the standard of care for PrEP provision. At the intervention site, the investigators will implement a three-pronged intervention:

1. During healthcare outreach events we will conduct PrEP workshops, in which people who want to know more about PrEP learn basic facts about PrEP and are taught skills about how to advocate for PrEP in their community.
2. Check-in Calls: To support PrEP adherence, healthcare workers will call PrEP users two weeks after initiation, and the week before refill events, to check in about any questions and to remind them of the next date and place to pick up refills. Calls after PrEP initiation will ask about side effects.
3. To support PrEP adherence, healthcare workers will encourage PrEP users to select an adherence supporter, who is a family member or friend to whom they disclose their PrEP use. The adherence supporter agrees to remind the PrEP user to adhere to PrEP and get refills. Healthcare workers will ask the PrEP user for the name and contact information for the adherence supporter, so that the adherence supporter can be contacted to remind them about refills, as well as if the PrEP user does not show up for a refill.

Eligibility Criteria:
Inclusion Criteria for PrEP initiation:

* Tests HIV-negative at a healthcare outreach/HIV testing event in one of the two selected fishing communities and is PrEP-eligible

Exclusion Criteria:

* Not meeting the inclusion criteria
Validity and Reliability of Vietnamese Version of 17items-Hamilton Depression Rating Scale

this reseach examines the reliability and validity of 17 items- Hamilton Depression rating scale in Vietnamese population, which has been commonly used in clinical depression practice and study.

- Cross-sectional study

Eligibility Criteria:
Inclusion Criteria:

* patients accept paticipating in reasearch

Exclusion Criteria:

* patients don't answer full HRDS
Non-invasive Nerve Stimulation and Sleep

People often have difficulty sleeping. Reasons are many. But, difficulty falling and staying asleep are common issues. Sleep difficulties are common in disorders such as Post Traumatic Stress Disorder. Current treatments for sleep difficulties are not effective for everyone. Better treatments are needed. In this study, the investigators are testing two nerve stimulation locations that may impact brain function in such a way that sleep is improved.

People often have difficulty sleeping. Reasons are many. But, difficulty falling and staying asleep are common issues. Sleep difficulties are common in disorders such as Post Traumatic Stress Disorder. Current treatments for sleep difficulties are not effective for everyone. Better treatments are needed. In this study, the investigators are testing two nerve stimulation locations that may impact brain function in such a way that sleep is improved.

Eligibility Criteria:
Inclusion Criteria:

* Condition: Hx VA/DOD criteria PTSD w or w/o mTBI and current sig symptoms of PTSD
* English fluency

Exclusion Criteria:

* Neurological injuries or conditions aside from mTBI that may affect outcome variables and/or other variables in the study
* Psychiatric issues that are unlikely to be related to trauma that may affect outcomes and/or other variables in the

  * e.g., schizophrenia
* Untreated sleep apnea

  * CPAP controlled sleep apnea is okay
* Major uncorrected sensory deficit
* Current drug or alcohol abuse

  * Drug abuse within the last two months will result in exclusion or delay
  * Marijuana use or alcohol intoxication within 2 weeks of study will be acceptable
* No pregnancy
Developing a Physically More Active Lifestyle Based on One's Own Values - RCT Among Sedentary Adults

The main objective of the study is to provide data of the effectiveness and feasibility of the Acceptance and Commitment Therapy in enhancing the physically active lifestyle among sedentary adults. The psychological and motivational factors related to physical activity and behavior change will also be evaluated.

In more detailed the study aimed to investigate the effectiveness of the acceptance- and commitment-based behavioural intervention concerning physical activity level and self-efficacy, as well as regarding planning and the acceptance of psychological and physical discomfort related to physical activity after 3 and 6 months compared to providing only individual written feedback on their physical activity. A further aim was to explore stability and maintenance of changes in physical activity at the 6 months follow-up. It was hypothesised that acceptance- and commitment-based behavioural intervention is more effective than feedback only in improving physical activity and related beliefs and cognitions.

Eligibility Criteria:
Inclusion Criteria:

* age 30-50 years, working status, and don´t meet the current physical activity recommendations.

Exclusion Criteria:

-
Tacrolimus, Sirolimus and Ustekinumab vs. Tacrolimus and Sirolimus for the Prevention of Acute Graft-Versus-Host Disease

To determine whether treatment with ustekinumab will alter the ratio of T Regulatory Cell (Treg)/total cluster of differentiation 4 (CD4)+ cells in peripheral blood at day 30 post-hematopoietic cell transplantation (HCT).

This is a comparative study to assess the biologic and clinical activity of the agent ustekinumab when given in concert with our established regimen of SIR/TAC. Patients will be randomly assigned between the standard regimen of tacrolimus/sirolimus (TAC/SIR + placebo) vs. the investigational regimen of tacrolimus/sirolimus/ustekinumab (TAC/SIR/U) in a 1:1 scheme.

Eligibility Criteria:
Inclusion Criteria:

* Hematologic disorder requiring allogeneic hematopoietic cell transplantation
* Adequate vital organ function:
* Left ventricular ejection fraction (LVEF) \>/= 45% by multigated acquisition (MUGA) scan
* FEV1, FVC, and diffusing lung capacity oxygenation (DLCO) \>/= 50% of predicted values on pulmonary function tests
* Transaminases (AST, ALT) \< 3 times upper limit of normal values
* Creatinine clearance \>/= 50 cc/min.
* Performance status: Karnofsky Performance Status Score \>/= 60%.

Exclusion Criteria:

* Active infection not controlled with appropriate antimicrobial therapy
* HIV, hepatitis B, or hepatitis C infection
* Sorror's co-morbidity factors with total score \> 3
* Important modification to co-morbidity index calculation: DLCO will not be included in assessment of pulmonary risk, excepting those with DLCO \< 50%, who will merit a score of 3 and thereby be excluded from the trial.
* Anti-thymocyte globulin (ATG) as part of the conditioning regimen
* Cyclophosphamide as part of the conditioning regimens
Information to Parents of Children With Cancer. An Exploratory Study

The aim of this study is to explore whether an intensified informational intervention built upon the Representational approach framework can reduce stress in parents of children with cancer.

BACKGROUND

Parents of children with cancer have great information needs and report that these are not always met. Psychosocial suffering such as stress and anxiety is also common in this group.

HYPOTHESIS

An informational intervention emanating from the needs identified by parents is associated to decreased perceived stress, decreased depressive symptoms, decreased anxiety, increased satisfaction with information and decreased use of health care contacts in parents.

INTERVENTION

The intervention builds upon the Representational approach. This approach emanates from Leventhal's theories of illness representations and theories of conceptual change. Central qualities in the approach is that parents identify the area where information is needed themselves and that a thorough assessment of their current representation of that area is performed before information is given.

Each participating parent receives three rounds that consist of two meetings. Each round starts with a meeting where the parent identifies an area where he/she needs more information. The nurse and the parent jointly survey the parent's representation of the area and discusses consequences of knowledge gaps or misunderstandings. Then, new information is introduced and benefits from the new information is discussed. After some days, a follow-up meeting takes place.

DESIGN AND METHODS

The intervention will be evaluated using a single-case design (A-B-A-B-A-B-A) with 10 parents. All parents will receive the intervention, and repeated measures of the outcome variables both before and after will be used to assess the effect of the intervention. Data will be collected by web questionnaires with SMS- and e-mail reminders.

In parallel, a process evaluation aiming at describing treatment fidelity, experiences of participation and impact of contextual factors on the results. For this aim, qualitative interviews with participants and audio recording of intervention sessions will be used.

Eligibility Criteria:
Inclusion Criteria:

* Being a parent of a child that

  1. is diagnosed with a first occurrence of a malignancy that is curatively treated
  2. was diagnosed two months ago
* Able to talk, read and write Swedish enough to be able to participate without an interpreter
* Have access to a computer and an internet connection.
Early Rehabilitation After Hand or Wrist Ambulatory Surgery : How to Preserve Locomotion at Home Without Rebound Pain?

The purpose of this retrospective study is to compare the analgesic efficacy of Walant " Wide Awake Local Anesthesia No Tourniquet " with lidocaine and bupivacaine versus axillary brachial plexus block using mepivacaïne, both performed by anesthesiologists, after hand or wrist ambulatory surgery.

The main objective is to prove that Walant block improve pain relief at home measuring time to first analgesic request.

The secondary objectives are to compare maximal pain, consumption of supplementary analgesics, and the duratin of sensory block between groups.

data will be collected on patient records and will be compared between groups of regional anesthesia.

Data will be :

* time to first analgesic request
* sensory block
* rescue analgesia during the first 24 hours after surgery
* maximal pain score during the first 24 hours after surgery
* patient satisfaction of managing care

Eligibility Criteria:
Inclusion Criteria:

- All adults patients scheduled for hand or wrist ambulatory surgery since 2016

Exclusion criteria:

- NA
Alternate Dosing Regimens of BG00012 in Healthy Volunteers

The purpose of this study is to evaluate the safety, tolerability, and PK of different doses and dosing regimens of BG00012 administered with and without ASA compared to placebo

Preclinical safety margins for BG00012 allow for a maximum daily dose of 720 mg daily. The study will use a variety of clinical scales, including a flushing scale derived from a validated questionnaire \[Norquist 2007\], to better understand the safety and tolerability of several doses and dosing regimens of BG00012 up to a total daily dose of 720 mg. The etiology of BG00012-induced flushing will be assessed by collecting relevant biomarker data and the impact of ASA on flushing will be evaluated. Assessments relating to GI symptoms will also be performed.

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
* Aged 18 to 55 years old, inclusive, at the time of informed consent.
* Must be in good health, as determined by the Investigator, based on medical history and screening evaluations.
* Must have a body mass index of 18 to 34 kg/m2, inclusive.
* Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.

Exclusion Criteria:

* History of any clinically significant cardiac, endocrinologic, GI, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the Investigator.
* History of malignant disease, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).
* Serious infection (e.g., pneumonia, septicemia) as determined by the Investigator within the 3 months prior to Day 1.
* Diarrhea, constipation, abdominal pain, flushing, or nausea within 28 days prior to Day 1.
* History of severe allergic or anaphylactic reactions. Additionally, subjects with a history of intolerance to ASA or non-steroidal anti-inflammatory drugs (NSAIDS) must be excluded.
A Study to Assess the Effect of Diets With Different Protein Composition - Mainly Coming From Lean Red Meat - in Body Weight and Lipid Profile in Overweight and Obese Women

The objective of the study is to assess the effect of diets with different protein composition (20%, 27% and 35%), mainly coming from animal proteins such as lean red meat, on body weight and lipid profile in overweight and obese women. A dietary intervention is carried out during 3 months in 90 women who are individually randomized to an hypocaloric diet with three types of macronutrient composition: 1) 35% proteins, 30% fat and 35% carbohydrates; 2) 27% proteins, 30% fat and 43% carbohydrates and 3) 20% proteins, 30% fat and 50% carbohydrates. Around 50% of total proteins in diet come from lean red meat (leg or shoulder of lamb) by providing up to 15 different recipes to participants to use them as part of the diet. At the beginning of the study, after 6 weeks and at the end of the intervention, the following parameters are determined: anthropometric (weight, waist circumference, body mass index and body composition), blood pressure, dietary (72-hours dietary registry) and exercise assessments and biochemical analysis (total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, apolipoprotein A1, apolipoprotein B, iron, transferrin, ferritin, uric acid, glucose, HbA1c, insulin and adipokines). In 3-months visit, participants will be advised to follow the prescribed diets during the next 3 months. Monitoring visits with the nutritionist will not be performed. A follow-up visit will be done after 3-months of end of intervention (at 6-months after beginning the study) to assess the long-time efficacy on main endpoint of each diet. In this visit only anthropometric parameters (weight, waist circumference, body mass index and body composition) will be determined.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-80 years old.
* Body mass index between 27.5 - 40.
* Steady weight in last 3 months (±3 kg).
* Informed consent provided.

Exclusion Criteria:

* Presence of uncontrolled endocrinological pathology (including hypothyroidism).
* Type 2 diabetes mellitus with bad metabolic control (HbA1c \> 8%).
* Lipid-lowering drugs in the last 3 months.
* Intake of functional foods with plant sterols in the past 6 weeks.
* Vitamin supplements intake.
* Hormone replacement therapy.
* Consumption of Orlistat in the last 2 months
* High intake of alcohol (\> 30 gr./day).
* Any serious disease which involves less than 1 year life expectancy or, in investigators judgment, limit the follow-up of an homogeneous diet throughout the study.
* Pregnancy or intention of pregnancy during the study.
Preschoolers Learning and Active in PlaY

The overall aim of this proposal is to develop and test early childhood education setting-based physical activity (PA) interventions that are innovative by using wearable technology to facilitate monitoring, feedback and motivation for physical activity across multiple levels (child, parent, educator). We posit that our intervention strategies will promote behavior changes in parents and educators, leading to greater awareness and communication about physical activity, more active play opportunities, and ultimately more physical activity for preschoolers. In the R21, we will test the acceptability, feasibility and initial efficacy of three 6 month early childhood education setting- based, multi-level interventions to promote preschoolers' PA using wearable technology and additional behavior change techniques to engage educators and parents. The results of this study will inform a larger intervention trial.


Eligibility Criteria:
Inclusion Criteria:

* attends preschool in a child care center participating in this study
* no physical/health restrictions on participating in physical activities

Exclusion Criteria:

* unable to participate in all physical activities
CardioMEMS HF System Post Approval Study

The purpose of the CardioMEMS HF System Post Approval Study (PAS) is to evaluate the use of the CardioMEMS HF System in patients with NYHA class III heart failure in a commercial setting.

The primary objective of this study is to demonstrate the safety and to report clinical performance of the CardioMEMS™ HF System in real world setting.

Prospective, non-randomized, open-label, multi-center, post-market study designed to characterize the use of the CardioMEMS™ HF System in a real-world setting in the US; N=1200. It is the condition of approval study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of NYHA class III heart failure
* At least 1 heart failure hospitalization within previous 12 months
* Patients with reduced LVEF heart failure should be receiving a beta blocker for 3 months and an ACE-I or ARB for one month unless in the investigator's opinion, the patient is intolerant to beta blockers, ACE-I or ARB
* BMI ≤ 35. Patients with BMI \>35 will require their chest circumference to be measured at the axillary level. If \> 65 inches the patient will not be eligible for the study.
* Pulmonary artery branch diameter ≥ 7mm - (implant target artery - assessed during the right heart catheterization)

Exclusion Criteria:

* Active infection
* History of recurrent (\> 1) pulmonary embolism or deep vein thrombosis
* Inability to tolerate a right heart catheterization
* A major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within previous 2 months
* Cardiac resynchronization device (CRT) implanted within previous 3 months
* Glomerular Filtration Rate (GFR) \< 25 ml/min (obtained within 2 weeks of implant) who are non-responsive to diuretic therapy or who are on chronic renal dialysis
* Congenital heart disease or mechanical right heart valve
* Likely to undergo heart transplantation or VAD within the next 6 months
* Known coagulation disorders
* Hypersensitivity or allergy to aspirin, and/or clopidogrel
Evaluation of POC Lung Ultrasound Combined With Pressure-volume Curve to Titration Adjust PEEP for ARDS Lung Recruitment

Using lung ultrasound re-aeration score(LUS-RAS) combined with pressure-volume curve(PVC) adjust maintain positive end-expiratory pressure(PEEP) after recruitment maneuver, to achieve real-time adjustment, reduce ventilation-associated lung injury and the purpose of effective lung recruitment.

The traditional method, set PEEP according to PVC in ARDS mechanical ventilation, lacks morphological evaluation. For point-of-care lung ultrasound(POC-LUS) is non-invasive, real-time, visualization, no need transport patients, getting more and more attention in the ARDS treatment. It has been reported that LUS-RAS is a meaningful assessment in recruitment maneuver. This study will combine POC-LUS with PVC in set the initial peep, and then dynamic record LUS-RAS to feedback regulate PEEP. Using the POC-LUS and maximum oxygenation method to assess lung recruitment effect in experimental group and control group prospectively. The ventilator parameters, state of hemodynamic, arterial blood gas(ABG) in each group will be recorded; Statistical methods will be performed in term to understand the correlation.

Eligibility Criteria:
Inclusion Criteria:

* patient aged 18 years and older
* ARDS patients with invasive mechanical ventilation

Exclusion Criteria:

* Intracranial hypertension
* Pneumothorax and mediastinal emphysema
* Severe hypoxemia (oxygenation index \<100)
* Hemodynamic instability
* Chest deformity or surgical history
* Affect Lung-ultrasound conditions: subcutaneous emphysema, chest wound etc.