cyrilzakka/clinical-trials huggingface dataset:
RF Based QIMT & QAS Study on Chinese Adults

This study intends to establish the normal reference values of carotid artery intima-media thickness and vascular elasticity of Chinese adults based on ultrasound radio frequency technology through a multi-center large-sample study, which provides important information for the risk prediction and prognosis evaluation of Chinese adults' cardiovascular disease.

After being informed about the study, all participants giving written informed consent will undergo a one-time examination of vascular ultrasound, including general characteristics and the target ultrasound parameters.

To detect the smallest difference between adjacent age groups within the age range 18-79 (6 groups, α = 0.05, β = 0.20, Statistical Power = 0.80). Given the influence of multiple centers, the minimum sample size is 1800, the optimal sample size is 3500. The male to female ratio is 1:1.

Quality Control including the pre-study training and data monitoring during the study.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-79
* The blood pressure is normal: systolic blood pressure \<140 mmHg, and diastolic blood pressure \<90 mmHg
* The physical examination and electrocardiogram are normal

Exclusion Criteria:

* Subjects with carotid intima-media thickness ≥ 1.0 mm should be excluded;
* Subjects with previous cardiovascular disease history and medication history should be excluded. The main diseases include coronary heart disease, congenital heart disease, heart failure, hypertension, stroke, hyperlipidemia, diabetes, aortic arteritis, etc.;
* Subjects with past medical history and medication history of endocrine, rheumatism, chronic respiratory disease, liver and kidney disease should be excluded;
* Obese subjects (BMI ≥ 28 kg/m2), professional athletes, pregnant and lactating women should be excluded;
* Alcohol or drug addicts and smokers who have not quit smoking should be excluded.
Proton Therapy for Chordomas and/or Chondrosarcomas

The purpose of this study is to collect information from medical records to see what effects proton beam radiation has on cancer and analyze possible side effects.

Data collection will be obtained from the patient's medical records including initial evaluation, pathology report, dosimetry information, radiotherapy completion records and follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven chordoma or chondrosarcoma.
* Sites: base of skull and/or spine.
* Age 18 years or older.

Exclusion Criteria:

* Previous radiation to the head and neck or brain.
* Evidence of metastatic disease.
This Study Will Investigate How Food and Age Effect the Way the Body Handles the AZD5069 Drug Given as a Oral Dose

AZD5069 is a new drug being tested for the possible treatment of people with chronic obstructive pulmonary disease (COPD).

This is not the first time that AZD5069 will be administered to humans in clinical trials. We are conducting this study to determine whether AZD5069 is safe and well tolerated by healthy males and females in fed and fasted states. We will compare the way the body handles this drug in the fed and fasted states, in subjects in the age group of 18 to 65 years. We will compare the way the body handles this drug between the age groups of 18 to 65 years and above 65 years. We will also be studying how quickly AZD5069 is absorbed into and cleared by the body.


Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg.

Exclusion Criteria:

* Has participated in another clinical study and received drug treatment within 3 months of the first administration of drug in this study.
* Subjects with a past medical history of tuberculosis (TB).
* Subjects with latent or chronic infections
The Effect of Wound Edge Eversion on Cosmesis

Aesthetic appearance of repaired incisions is very important to surgical patients. It has been stated that if the edges of a wound are closed in such a manner that will result in eversion, or pouting of the edges that the end cosmetic result will be superior when compared to wound edges that are simply approximated. The purpose of this study is to compare cosmetic outcomes of incisions that are closed with everted edges to those in which the edges are simply approximated.

Surgical incisions will be split into two halfs and each half will be randomized to standard or everting sutures. 3 months later the cosmetic outcome of the healed wounds will be determined using a validated scar evaluation scale.

Eligibility Criteria:
Inclusion Criteria:

* age over 18.
* able to consent.
* scheduled for elective plastic or cardiothoracic surgery.

Exclusion Criteria:

* history of keloids, hypertrophic scarring, diabetes, or peripheral vascular disease.
* those requiring systemic steroids or undergoing chemotherapy, and those unable or unwilling to consent.
The Effect of Virtual Reality Glasses on Labor Pain

There are different medicinal and non medicinal methods to control labor pain. Today, much attention has been on non medicinal methods because of limitations and complications of medical procedures. Virtual reality is a new and promising method of diversion of mind that may have an impact on labor pain. This study was conducted to determine the effect of virtual reality on the first stage of labor pain.


Eligibility Criteria:
Inclusion Criteria:

* Iranian
* low risk pregnancy
* primipara

Exclusion Criteria:

* vision or ear disorders
* History of motion sickness or headaches
* psychological disease or Addiction
Safety and Efficacy of Grass Pollen Allergoid in the Treatment of Allergic Rhinoconjunctivitis

The trial is performed to assess efficacy and safety of the Grass Pollen Allergoid in Allergic Rhinoconjunctivitis

Pollen allergoids are prepared by chemical modification of partially purified native allergen aqueous extracts that have been depleted of components with a molecular mass of less than 5000 Daltons by diafiltration. Clinical studies have shown a good tolerance of aqueous grass, ragweed and tree pollen allergoids in comparison with allergen preparations. Adsorption of pollen allergoids onto aluminium hydroxide suspensions results in depot preparations which have been investigated in a series of clinical studies and shown to be well tolerated with good clinical efficacy. Depot pollen-allergoids were introduced into the German market in 1987 under the trade name Allergovit® and are now firmly established and recommended primarily for shortcourse preseasonal immunotherapy in pollinosis. Allergovit® is currently available in many European and non-European countries. A placebo-controlled study design was chosen as improvements in the symptoms of pollen allergies can not be shown over time, as pollen seasons of different years are not comparable. Due to the different mechanisms of action, specific immunotherapy can not be compared with anti-allergic drugs. Thus the only chance to prove efficacy for specific immunotherapy (SIT) is to test versus a parallel placebo group.

Eligibility Criteria:
Inclusion Criteria:

* Positive Skin Prick test to grass pollen
* Positive RAST to grass pollen
* Positive specific provocation test to grass pollen

Exclusion Criteria:

* Serious chronic diseases
* Other perennial allergies
Determination of the Characteristics of Isometric Gastric Motility Measurement in Healthy Volunteers

There is a clear need for a novel method that can readily assess gastric motility in daily clinical practice. Isometric determination of the stomach motility would avoid the use of a large flaccid balloon while still being affordable. The aim of this study was to determine the optimal balloon characteristics that enable to measure motility-induced pressure changes in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* They are between 18-60 years old.
* Male and female.
* Patients must provide witnessed written informed consent prior to any study procedures being performed.

Exclusion Criteria:

* They are older than 60 years old and younger than 18 years.
* They are taking medication.
* Have severely decreased kidney function.
* Have severely decreased liver function.
* Have severe heart disease, for example a history of irregular heartbeats, angina or heart attack.
* Have severe lung disease.
* Have severe psychiatric illness or neurological illness.
* Have any gastrointestinal disease.
* Have any dyspeptic symptoms.
* Women that are pregnant or breastfeeding.
Efficacy and Safety Evaluation of BCMA-UCART

This trial aims to evaluate the safety and efficacy of BCMA-UCART in treating patients with relapsed or refractory multiple myeloma.

BCMA(B-Cell maturation antigen) is a tumor antigen of multiple myeloma. Using a genetic engineering strategy to assemble an anti-BCMA CAR(chimeric antigen receptor) in T cells will help these CART cells to recognize and kill BCMA-expressing MM tumor cells. BCMA-UCART is a kind of allogeneic CART, originating from T cells of health donors. This open-label, dose-escalation study aims to evaluate the safety and anti-tumor efficacy of BCMA-UCART in treating relapsed or refractory multiple myeloma.

Eligibility Criteria:
Inclusion Criteria:

* Have the capacity to give informed consent;
* Confirmed diagnosis of active MM as defined by NCCN and IMWG criteria;
* Have a diagnosis of BCMA+ multiple myeloma (MM), (≥ 5% BCMA+ in CD138+ plasma cells by flow cytometry obtained within 45 days of study enrollment);
* Refractory and relapsed MM patients after \> 2 cycles of induction therapy,or,have relapsed or treatment refractory disease following autologous stem cell transplant (ASCT);
* ECOG score=0-2.
* Subjects according with any of the following options:

  * Age≥50;
  * Failure with separation of T cells during autologous CART processing; or,
  * Failure with expansion of autologous CART; or,
  * The proportion of T cells in PBMC \<10%; or,
  * Won't benefit from autologous CART therapy because of disease progress.

Exclusion Criteria:

* Pregnant or nursing women; Women of reproductive potential must have a negative serum pregnancy test performed within 48 hours of starting conditioning chemotherapy
* Active infection, HIV infection, syphilis serology reaction positive;
* Active hepatitis B, hepatitis C at the time of screening
* Significant hepatic dysfunction as following, SGOT(serum glutamic-oxaloacetic transaminase)\> 5 x upper limit of normal; bilirubin \> 3.0 mg/dL;
* Lymphotoxic chemotherapeutic agents within 2 weeks of leukapheresis
* serious mental disorder;
* With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
* Participate in other clinical research in the past three months; previously treatment with any gene therapy products
* Contraindication to cyclophosphamide or fludarabine chemotherapy
Etanercept Withdrawal And Retreament Study In Subjects With Nr-ax SpA

The purpose of this study is to study the benefits and risks of etanercept withdrawal in patients who have achieved a significant clinical response.

This multcenter, open-label, three period study will evaluate withdrawal and retreatment of etanercept in subjects with nr-ax SpA who achieved adequate response following 24 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of axial SpA duration of symptoms \>3 months and \<5 years back pain with a less than favorable response to NSAIDs

Exclusion Criteria:

* radiological sacroiliitis previous treatment with TNF inhibitor, biologic, immunosuppressive
Drum Circle Synchrony Study 2c.a.

Mental health vulnerability due to stress is increased in People of African Descent (PADs) in America due to disproportionate effects of racism, poverty, education, and criminal justice sentencing. Various meditation and mindfulness approaches have provided evidence of measured reductions in multiple negative dimensions of stress. However, the majority of these studies do not have an adequate representation of PADs or other marginalized groups and are not designed to be culturally relevant or community based. Music has been shown to alleviate multiple symptoms of stress and has been shown to be a preferred and effective support for meditation and mindfulness. However, its role in stress management in PADs engaged in meditation or mindfulness is seldom studied. This study aims to evaluate the effects of a virtual, community-based music mindfulness program on stress management in PAD community members with anxiety and depression during COVID19.

2c.a. Drum Circle Synchrony Study: This study will investigate the role that synchrony plays in subjective feelings of connection.

The investigators also propose a study to investigate the effects of communal drumming in reducing anxiety and increasing connectedness within drum circle community. Investigators hypothesize that these intervention will lead to reductions in scores on stress scales and will provide preliminary data for studies evaluating these types of community programs as an adjunct to the standard of care.

Musicians and non-musicians will listen to segments (\~30 sec duration) of recordings taken from the music made during a previous arm of drum circle and answer a survey. Segments will be categorized as highly synchronized or not synchronized.

Eligibility Criteria:
Inclusion Criteria:

* ages 18 and older

Exclusion Criteria:

* ages 17 and younger
Effect of olmesaRtan on Walking distancE and quaLIty of lifE in Peripheral Artery Disease Patients With Hypertension Treated For Intermittent Claudication (RELIEF)

To study the effect of olmesartan on walking distance and quality of life in peripheral artery disease patients with hypertension treated For intermittent claudication.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 20 and 85 years at visit 1
* Patients with ankle-brachial index (ABI) of less than 0.9 in one or both legs with history of intermittent claudication stable for the previous 6 months
* Patients whose statins, anti hypertensive medications and antiplatelet medications are stable for the past 6 months. Statins and cilostazol are allowed but needs to be stable for the past 6 months (diabetic medications may be changed)
* Patients whose blood pressure is more than 140/90 mmHg with/without anti-hypertension treatment

Exclusion Criteria:

* Blood pressure of more than 180/110 mmHg
* Patients taking ARBs or ACE inhibitors treatment for at least 6 months before
* Patients taking aldosterone receptor antagonists at least 6 months before
* Patients with serum creatinine of more than 3 mg/dL
* serum potassium (K+) \> 5.5mg/dl
* History of bilateral renal artery stenosis
* History of acute coronary syndrome or heart failure hospitalization within 6 months
* Peripheral arterial revascularization planned within 1 month
* Critical limb ischemia
* Patients with impaired cognition (e.g. dementia)
* pregnancy or women at age of childbearing potential
Effect of Prolonged Nightly Fasting on Immunotherapy Outcomes in HNSCC - Role of Gut Microbiome

This study aims to evaluate if eating within an 8-10-hour window during the day, without any caloric restriction, can lead to better response rates to immunotherapy in head and neck cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed recurrent /metastatic head and neck squamous cell cancer that is not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy) and initiating standard of care immune checkpoint blocker- (Nivolumab, pembrolizumab, Atezolizumab, Avelumab or Durvalumab with or without chemotherapy), for the first time.
* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as outlined in RECIST version 1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

Exclusion Criteria:

* BMI\< 18.5.
* Diabetes mellitus, hyperthyroidism, pregnancy, any eating disorder including anorexia nervosa or bulimia, metabolic disorders that may affect gluconeogenesis or adaptation to short fasting periods
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, autoimmune disease requiring systemic steroids, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Patients who have known leptomeningeal metastases or untreated or symptomatic brain metastases. Treated, asymptomatic brain metastasis can be included.
Molecular Basis of Food Allergy

The Study examines the molecular basis of food allergy. It explores the interaction between T cells, InKT cells, basophils and cytokines in the development of food allergy. The study also explores these factors in development of tolerance "outgrowing" food allergy. It will also explore the genetic factors that lead to the development of food allergy.

The study examines all type of food allergy including IgE mediated reactions, Eosinophilic Esophagitis and Food Protein Induced Enterocolitis

Food Allergy (FA) is a common pediatric atopic disease. Characteristically children affected by FA become sensitized to food in the first few months of life and spontaneously outgrow the disease by 5-6 years of age in about 80% of cases. At the present time, diagnosis of FA is made by a combination of history, skin testing and food challenge. The pathogenic mechanisms leading to food sensitization and subsequent spontaneous tolerance development are not understood.

Eligibility Criteria:
Inclusion Criteria for Study Group:

1. Males or females age 1 month to 65 years.
2. Diagnosis of Food Allergy. Food Allergy can be either IgE or non-IgE mediated food allergy including Eosinophilic Esophagitis and Food Protein Induced Enterocolitis.

Inclusion Criteria for Control group:

1. Age and sex matched patients without food allergies
2. Sibling and parents of patients with food allergies

Inclusion Criteria for Control group with atopy:

1. Age and sex matched patients without food allergies
2. Sibling and parents of patients with food allergies
3. Patients with atopy

Exclusion Criteria

1. Underlying disease or medical problem that is judged to serious or risky to allow 3 ml/kg of blood to be drawn from a vein (such as serious anemia, cancer, poor vein abscess, serious infections).
2. Subjects that do not meet the enrollment criteria may not be enrolled. Any violations of these criteria will be reported in accordance with Institutional Review Board (IRB) policies and procedures study procedures.
Translation of Obesity and Cognitive Program by Lay Health Educators

Obesity is a major public health problem among older adults, with 31% of non-institutionalized older persons (60 years+) in the US obese and projections indicating that this will rise to 40% by 2010. A second public health challenge on the horizon for the aging US population is the increasing number of individuals experiencing cognitive decline, dementia or Alzheimer 's disease. Recent clinical trials have demonstrated efficacy in reducing risks associated with both of these significant and increasingly pervasive health problems, which are more common among rural, low income and ethnic minority populations. The Diabetes Prevention Program (DPP) Lifestyle Intervention produced sustained weight losses in a large, diverse population of high-risk individuals and dramatically reduced rates of type 2 diabetes onset, particularly among older adults. SeniorWISE produced improvements in memory in community dwelling older persons. Transferring these exciting technologies to community settings where they can benefit older adults is a pressing public health need. Therefore, the current project seeks to transfer these two evidence-based interventions to older adults in a rural state using senior centers as the venue for dissemination and lay health educators to deliver the interventions. Senior centers are a particularly attractive context for translation of evidence-based health promotion technologies in predominantly rural states like Arkansas because they have a well-established infrastructure in communities and share a common goal of promoting healthy aging and reducing health care costs. The 3-year randomized, controlled trial will evaluate translation of the interventions by randomizing senior centers (N=16) across Arkansas to implement either (1) the DPP Lifestyle Weight Loss Program or (2) the SeniorWISE Cognitive Training Program. Older (age \> 60) adults (N=288) nested within senior centers will receive the programs delivered in a group format by a trained lay health educator. Primary outcomes are changes in body weight and cognitive functioning at 12 months. The multi-level evaluation plan will characterize reach, effectiveness, adoption, implementation and maintenance of the interventions, with a cost effectiveness component.


Eligibility Criteria:
Inclusion Criteria for senior centers (unit of randomization):

* located in the state of Arkansas
* agree to be randomized
* able to identify two or three volunteers or staff members willing to be trained (including IRB certification) and deliver the programs within the senior center over the course of a year
* have adequate space for group meetings and for private data collection visits
* agreement that it would be likely that they could identify 18 interested and eligible (obese and not cognitively impaired) senior adults willing to attend the program over the course of 12 months

Exclusion Criteria:

* inability to identify and secure lay health educator from within their community
* concerns of inability to recruit the requisite 18 senior adult participants who met minimal inclusion criteria
High Intensity Interval Training and Skeletal Muscle Insulin Sensitivity

This human intervention study will test if 12 weeks of supervised HIIT-based intervention improves skeletal muscle NOGD capacity in obese subjects.

19 overweight-obese (BMI =\> 27kg/m2), sedentary females and males aged 45-75yr will be enrolled in this study.

Participants will train 3 times/week under supervision during 12 weeks. Before, after and during this 12-week training period, there will be multiple metabolic measurements.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age 45 - 75 years old
* Overweight to obese (BMI =\> 27kg/m2)
* Sedentary - subjects do not perform any regular physical activity weekly(\<3 times per week, \<150 min/week).

Exclusion Criteria:

* Unstable body weight (weight gain or loss \> 3 kg in the past three months)
* Participation in an intensive weight-loss program or in vigorous exercise program during the last year before starting the study.
* HbA1c \> 6.5% and glucose clearance rate \>350 ml/kg/min (by OGTT).
* Previously diagnosed with type 2 diabetes
* Active cardiovascular disease. This will be determined by the questionnaires and by screening on medication.
* Use of beta-blockers
* Anticoagulant therapy
* Systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg
* Abuse of alcohol (\> 3 units (1 unit = 10 gr ethanol) per day)
* Any contra-indication to Magnetic Resonance Imaging (MRI) scanning
* Participation in another biomedical study within 1 month before the first study visit, which may interfere with the outcomes of the present study.
* Use of any medication affecting the glucose homeostasis and whole body metabolism or diseases that may significantly interfere with the main aim of the study.
* Chronic renal dysfunction (creatinine \>2 increased (normal value 64-104 µmol/l)
* Subjects who do not want to be informed about unexpected medical findings during the screening / study, or do not wish that their physician is informed, cannot participate in the study.
* Subjects will be included only when the dependent medical doctor of this study approves participation after evaluating all data obtained during the screening.