cyrilzakka/clinical-trials huggingface dataset:
Neighborhoods and CVD Risk in a Multiethnic Cohort - Ancillary to MESA

To investigate if neighborhood characteristics are related to disease risk in a multiethnic cohort.

BACKGROUND:

Recent epidemiologic studies have found that living in socioeconomically disadvantaged neighborhoods is associated with increased prevalence and incidence of coronary heart disease, even after controlling for measures of personal income, education, and occupation. Although this suggests that features of neighborhoods may be relevant to cardiovascular risk, important questions remain regarding whether the associations observed reflect causal processes. Two important unresolved issues are the role of selection factors in generating these associations and the need to identify the specific characteristics of neighborhoods that are relevant.

DESIGN NARRATIVE:

The study uses publicly available and newly collected neighborhood data linked to the Multi-Ethnic Study of Atherosclerosis (MESA) to: (1) examine the relationship between neighborhood socioeconomic characteristics and the prevalence and progression of subclinical atherosclerosis; (2) examine associations of neighborhood socioeconomic characteristics with specific individual-level factors which may mediate neighborhood differences in disease risk; (3) develop measures of specific characteristics of neighborhood environments (such as measures of resource availability, neighborhood social cohesion and neighborhood stress) and examine their relation to selected individual-level risk factors; (4) determine if these specific neighborhood characteristics explain differences in cardiovascular risk between socioeconomically advantaged and socioeconomically disadvantaged neighborhoods; and (5) examine if neighborhood characteristics contribute to race/ethnic differences in cardiovascular risk. Measures of neighborhood attributes will be based on Year 2000 Census data, surveys of area residents, and the use of GIS methods to link data on area resources to MESA neighborhoods. The examination of subclinical disease as outcomes avoids problems related to selection of persons into neighborhoods based on their health status. The project will use two innovative approaches (residential surveys and ecometric techniques and GIS-based methods) to develop direct measures of specific neighborhood attributes in order to test their relationship to disease risk. Confirming that specific features of neighborhoods are causally related to disease would have important implications for prevention.

Eligibility Criteria:
No eligibility criteria
Sensitivity and Specificity of Serum and Salivary CYFRA21-1 in the Detection of Malignant Transformation in Oral Potentially Malignant Mucosal Lesions (Diagnostic Accuracy Study)

The study is designed to measure serum and salivary CYFRA21-1 levels using enzyme linked immunosorbent assay (ELISA) in patients with oral malignancy, oral potentially malignant lesions, and control subjects to evaluate the potential of CYFRA21-1 as a diagnostic marker for malignant transformation in potentially malignant oral mucosal lesions.


Eligibility Criteria:
Inclusion Criteria:

participants will be divided into 3 groups:

* Group I: patients suffering from oral potentially malignant lesions (PML) as defined by World Health Organization.
* Group II: patients suffering from diagnosed oral malignant lesions
* Group III: healthy subjects who are systemically free, non-smokers, and not suffering from any oral mucosal lesions.

Exclusion Criteria:

* Subjects taking any drugs inducing any changes that could affect the salivary flow.
* Pregnant females.
* Subjects have any allergies, infectious diseases or active dental abscesses during one month before saliva sampling.
* Patients receiving any drugs related to the oral lesions in the past 6 month prior to sample collection.
Effects of a Single Bout of Resistance Training Session on Hormonal Response in Pre-pubertal and Pubertal Boys

: Resistance training induces strength gains in both children and adolescents. Exercise training is linked to anabolic functions through the GH-IGF-I axis. This has been demonstrated in studies showing a higher activity of GH and IGF-I in fitter adolescents and adults. Exercise also stimulates pro-inflammatory cytokines (IL-1β, IL-6, TNF-α) that suppress the GH-IGF-I axis. This has been observed in endurance-type training, while resistance training has received less attention.

Boys experience a significant physiological muscle-growth change during puberty that is associated with increases in boys androgen levels. How maturation affects the hormonal response to resistance training in boys is unclear. Therefore, the purpose of the study is to compare the acute effects of a single bout of resistance training on hormones and pro-inflammatory cytokines in pre-pubertal and pubertal boys.

Preliminary measurements:

Preliminary testing will include anthropometric measurements of body mass, height, body fat percentage, and lean leg volume (LLV). The maturation stage will be determined according to the Tanner scale. There will also be an assessment of maximal strength testing to determine exercise intensity for each individual. Two familiarization sessions will be conducted for muscular strength before the muscular strength testing session.

Main trial A venous blood sample will be collected pre-exercise at resting condition. The trial will start with a standardized warm-up followed by a short (20-30 min), high-intensity whole-body resistance training session. Venous blood samples will be collected immediately after the completion of the training session and during the recovery period.

Eligibility Criteria:
Inclusion Criteria:

* Healthy boys (n=40)
* Physically active, defined as a minimum of 2 years experience in a sports club
* Biological age range: 20 pre-pubertal (Tanner I-II) - 20 pubertal (Tanner III-IV) boys
* No previous experience of structured resistance training

Exclusion Criteria:

* Chronic diseases that affect full participation
* Injuries that limit full participation
Comparison of the Effect of NN5401 With the Effect of NN1250 and Insulin Aspart in Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of this trial is to compare the blood glucose-lowering effect of NN5401 (insulin degludec/insulin aspart, IDegAsp) with NN1250 (insulin degludec, IDeg) and insulin aspart (IAsp) in subjects with type 1 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months.
* Body mass index 18.0-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day).
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
Study of a New Technique for Imaging Pancreatic Cancer

The purpose of this study is to see how well the experimental imaging agent 89Zr-DFO-HuMab-5B1 attaches to pancreatic tumors, and to find out whether PET/CT scans done with this imaging agent produce better images of cancer.


Eligibility Criteria:
Inclusion Criteria:

PART I : ESCALATION, EXPANSION, RE-ENTRY COHORTS:

* Histologically confirmed, locally-advanced, or metastatic pancreatic ductal adenocarcinoma (PDAC) or other malignancies known to express CA19-9 positive malignancies

PART II: PRE-SURGERY COHORT ONLY:

* Patients with biopsy-proven or high suspicion on imaging for pancreatic ductal adenocarcinoma (PDAC) (Stage T2 and T3)
* Patients scheduled referred to surgery or biopsy as standard of care for their pancreatic adenocarcinoma OR
* Patients with Intraductal papillary mucinous neoplasm (IPMN) referred to surgery or biopsy as standard of care.

The suspicion for pancreatic carcinoma and decision for surgery or biopsy will be based on review of imaging and clinical findings in the disease management team discussion including surgeon and radiologist.

PART I and II:

* Signed, informed consent
* Age 18 or more years
* At least one lesion by CT or MRI ≥ 2 cm, unless determine otherwise for pre-surgery cohort subjects
* CA19-9 serum level:

  * For Part I: \>ULN or CA19-9 positive biopsy (optional);
  * For Part II ( presurgical cohort): CA19-9 serum level (normal or high levels are allowed) or CA19-9 positive biopsy (optional)
* ECOG performance status of 0 to 2
* Adequate laboratory parameters including:

  * Absolute neutrophil count (ANC) ≥1.5 x 10\^9/L
  * Hemoglobin ≥ 9.0 g/dL (in the absence of red blood cell transfusions in the prior 14 days)
  * Platelet count \>75,000/ mm\^3
  * AST/SGOT, ALT/SGPT ≤2.5 x ULN, unless liver metastases are clearly present, then ≤5.0 x ULN
  * Total bilirubin ≤1.5x the upper limit of normal unless considered due to Gilbert's syndrome in which case, ≤3x the upper limit of normal
  * Creatinine (serum or plasma) ≤ 1.5 x ULN or eGFR\>50 mL/min

PART I: ESCALATION, EXPANSION, RE-ENTRY COHORTS:

* Willingness to participate in collection of pharmacokinetic samples

Exclusion Criteria:

* Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
* Major surgery other than diagnostic surgery within 4 weeks of Study Day 1
* History of anaphylactic reaction to human, or humanized, antibody
* Other on-going cancer therapy or investigational agents (except MVT-5873)
* Known history of HIV
* Pregnant or currently breast-feeding
* Psychiatric illness/social situations that would interfere with compliance with study requirements
* Prior entry onto this protocol 3 or more times (e.g., subjects may enter this protocol and be imaged up to 3 times)
Prevention of Endotracheal Tube Migration by Cuff Palpation During Robotic Surgical Procedure

After intubation, the endotracheal tube was finally fixed after palpating endotracheal cuff at three sites (just below the cricoid cartilage, at suprasternal level and just below suprasternal notch). Fibre optic bronchoscopy will be done to find distance between tip of endotracheal tube and carina. This distance will be measured repeatedly, after pneumoperitoneum, after trendelenburg position and after making the patient supine at the end of surgery. Change in the distance will be noted.

The endotracheal tube (ETT) will be placed according to the black mark on the tube, post-intubation, the tube will be finally fixed after palpating endotracheal cuff at three sites (below cricoid cartilage, at suprasternal level and just below suprasternal notch). ETT cuff position will be scanned by sonography of airway to confirm the position of the proximal end of the ETT cuff. Fibre optic bronchoscopy will be done to find distance between tip of endotracheal tube and carina. This distance will be measured repeatedly 5 minutes after pneumoperitoneum, 10 minutes after trendelenburg position and 10 minutes after making the patient supine at the end of surgery. Change in the distance will be noted to confirm the migration of ETT.

Eligibility Criteria:
Inclusion Criteria:

* Robotic uro-oncological surgical procedures of perineum
* Robotic gynae-oncological surgical procedures of perineum

Exclusion Criteria:

* Upper airway fibrosis or tracheal stenosis
* Large neck swelling distorting or deviating the trachea.
* Head and neck surgeries
* Laryngeal and tracheal tumour
* Tracheal surgery
* Previous tracheostomy
* previous radiation treatment of neck
Wound-healing Improvement by Resurfacing Split-Thickness Skin Donor Sites With Thin Split-thickness Grafting

Split-thickness skin grafting remains fundamental treatment of patients with deep burns and other traumatic injuries. However, the split-thickness skin graft (STSG) donor site dressing has been controversial until now. Our study here aimed to assess patient comfort and wound-healing efficacy with the application of thin split-thickness grafting on STSG donor sites.

Background：Split-thickness skin grafting remains fundamental treatment of patients with deep burns and other traumatic injuries. However, the split-thickness skin graft (STSG) donor site dressing has been controversial until now. Our study here aimed to assess patient comfort and wound-healing efficacy with the application of thin split-thickness grafting on STSG donor sites.

Methods: 192 consecutive patients undergoing split-thickness skin grafting were included in the study and the participants were randomly divided into three groups: Group A was regrafted with thin STSG, while, Group B and Group C were covered with the occlusive hydrocellular dressing and paraffin gauze, respectively. The three groups were compared regarding to the time of epithelialization, pain sensed by the patients and the scar formation.

Eligibility Criteria:
Inclusion Criteria:

* patients who continuously received an STSG from January 2002 to December 2010 in Department of Burn and Plastic Surgery, Tangdu Hospital, Fourth Military Medical University

Exclusion Criteria:

* The patients who were significant psychiatric, hypersensitive to silver, and not be followed up were excluded
Examination of the Impact of CalmiGo's Stress Management Device on Vascular Heath and Cardiovascular Disease Risk.

The primary purpose of this study is to determine if there are significant differences with respect to baseline between those randomized to CGo and standard-of-care versus standard-of-care alone after completing 12-weeks of therapy in terms of peripheral endothelial function measured by EndoPAT.

100 patients who have recently had an acute Myocardial Infarction ( heart attack) and are under going clinically indicated cardiac rehabilitation will undergo baseline testing including EndoPAT testing, mental stress testing, blood tests for cardiovascular disease biomarkers , physical assessments \& survey questionnaires. Patients then will be randomized to either CalmioGO stress management device + standard of care treatment or just standard of care treatment. Those randomized to CalmiGO stress management device treatment will be instructed to use the hand device much like an inhaler once a day for 12 weeks. After 12 weeks of rehabilitation both groups will return for reassessment of baseline tests.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Ability to use the CamliGo device for 12-weeks
* Willingness to complete study questionnaires, blood tests,\& EndoPat testing at the beginning and end of study
* Patients who have had a recent MI who will be undergoing clinically indicated Cardiac Rehabilitation
* Patients who have had a coronary or structural intervention performed in the cardiac catheterization laboratory within the last month, including: coronary stenting; coronary balloon angioplasty; transcatheter aortic valve replacement; mitral valve interventions; patent foramen ovale closures; alcohol septal ablation; paravalvular leak closure.
* Patients being seen in the Chest Pain Clinic for Atypical chest pain

Exclusion Criteria:

* Cognitively impaired patients
* Patient with Bipolar disorder, psychosis or delusional disorder
* History of substance abuse or dependence
* History of suicidality
* Unstable cardiovascular or pulmonary disease
* History of seizures
* Latex allergy
Comparison of Microneedling vs. Autologous Concentrated Growth Factor for the Treatment of Female Androgenetic Alopecia

Microneedling and autologous concentrated growth factor (CGF) have established their potential effect in inducing hair regrowth. No study has compared the effect of microneedling and CGF in the treatment of female androgenetic alopecia (AGA).

Microneedling is a minimally invasive technique consisting of sterile microneedles for repetitive cutaneous puncturing that increase hair regrowth by growth factor release. Concentrated growth factor (CGF) is a form of platelet concentrate (PC) and concentrates higher levels of growth factors because of its varying programmed centrifugation process. Previous studies have showed that CGF injection in hairless scalp could enhance the hair density and optimize the hairless appearance in AGA patients. Both microneedling and CGF have established their potential effect in inducing hair regrowth. No study has compared the effect of microneedling and CGF in the treatment of female androgenetic alopecia.

Eligibility Criteria:
Inclusion Criteria:

1. age between 18 and 65 years;；
2. clinical diagnosis of female pattern hair loss；
3. no previous laser treatments for AGA in the past six months before enrollment； 4) willingness to provide pictures and follow-up studies.

Exclusion Criteria:

1. if presented with severe diseases of internal organs, eyes, or skin;
2. inflammation, infection, or unhealed wounds on the skin around the site of treatment on the head;
3. systematic treatment with corticosteroids or other immunosuppressants and immunomodulators in the past 3 months.
Awareness and Knowledge of the Surgical Safety Checklist Among Operational Staff in University Teaching Hospital, Kathmandu, Nepal: A Cross-sectional Questionnaire

The introduction of the World Health Organization Surgical Safety Checklist (WHO SSC) is a priority to promote surgical safety. However, little is known regarding awareness and knowledge of the WHO SSC in developing countries. This study aimed to obtain region-specific information for the introduction of the checklist in a core medical institution in Nepal.

The present research was a cross-sectional study using data from a survey conducted at the Tribhuvan University Teaching Hospital (TUTH) in Kathmandu, Nepal. A questionnaire was distributed to 150 healthcare professionals working in the operating theatre. Responses to the questionnaire were analysed descriptively and regression analyses identified factors associated with awareness of the checklist.


Eligibility Criteria:
Inclusion Criteria:

* have optimal experience

Exclusion Criteria:

* less experience
Pharmacological Profile of Different Berberine Formulations, and Effects on Blood Sugar Levels

The primary objective of this study is to evaluate the gastrointestinal absorption of berberine (hydrochloride) in a novel formulation in healthy adult volunteers by comparing it with free berberine (hydrochloride) formulation. Several pharmacokinetic parameters are compared.

As secondary objective, the immediate or short-term effects of Berberine supplementation on blood sugar levels in healthy volunteers are evaluated via a glucose tolerance test (OGTT) using a portable glucometer.


Eligibility Criteria:
Inclusion Criteria:

* Age 21-65
* healthy, good physical condition

Exclusion Criteria:

* Pregnancy or breast-feeding
* Gastrointestinal conditions
* Acute or chronic liver disease
* Acute or chronic kidney disease
* Acute or chronic cardiovascular disease
* Hematological disease
* Diabetes
* Allergy or Intolerance to gluten
* Allergy or Intolerance to Berberine
* Use of any form of nicotine or tobacco
* Alcohol and substance abuse history
* Use of medications (e.g., blood sugar-lowering agents, or statins)
* Use of Berberine supplements
* Participation in another investigational study
Testing the Effect of a Caution for Drugs Approved on Surrogate Outcomes Alone

The purpose of this study is to test whether cautions about the evidence, in this case an "open questions" statement, decreases enthusiasm for drugs that are approved on surrogate outcomes (compared to patient outcomes) alone.


Eligibility Criteria:
Inclusion criteria

* Participants will be randomly selected from a research panel of more than 60,000 U.S. households (Knowledge Networks).
Long-term Effect of Hypnosis in Spinal Cord Injury Patients

Coping-oriented hypnotic suggestions aimed at reducing pain catastrophizing was shown to reduce pain in people with chronic tension-type headache and experimental pain in healthy volunteers during hypnosis (Kjøgx et al., 2016). However, the duration of the effect on pain post-hypnosis is unknown.

The aim is to investigate the durational effect of a single session of coping-oriented hypnotic suggestions on chronic pain in patients with spinal cord injury. If effective for a longer period post-hypnosis, this form of hypnosis may provide an alternative to medicine or may be used in conjunction with lower medicine dosages.

Methods: 75 patients with spinal cord injury and pain is randomized into one of three conditions; coping-oriented hypnosis plus current treatment, neutral hypnosis plus current treatment or current treatment only. Pain intensity, coping strategies, pain catastrophizing, anxiety and depression is assessed before intervention and over a period of 14 days post-intervention.


Eligibility Criteria:
Inclusion Criteria:

* Spinal cord injury (tetraplegia or paraplegia) with some preservation of hand functioning
* Baseline pain level of ≥ 3 on a Numeric Rating Scale (NRS; 0-10 where 10 is extremely severe pain)
* Pain duration of at least 8 weeks.

Exclusion Criteria:

* Severe mental or psychiatric illness
* Substance abuse (drugs, alcohol or medicine)
* Lack of ability to cooperate during the experiment
* Severe high cervical lesions
* Severe autonomic dysautonomia
AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer

This study will evaluate AMG 162 in the treatment of bone loss in subjects undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer.


Eligibility Criteria:
Other criteria also apply
Clinical Trial of Autologous Intravitreal Bone-marrow CD34+ Stem Cells for Retinopathy

This pilot study is to determine whether it would be safe and feasible to inject CD34+ stem cells from bone marrow into the eye as treatment for patients who are irreversibly blind from various retinal conditions.

In this pilot clinical trial, eyes with irreversible vision loss from retinal degenerative conditions (macular degeneration or retinitis pigmentosa) or retinal vascular disease (diabetic retinopathy or retinal vein occlusion) will be treated with intravitreal injection of autologous CD34+ stem cells isolated from bone marrow aspirate under Good Manufacturing Practice conditions. This study will determine whether there are any major safety and feasibility concerns using this therapy. Patients will be followed for 6 months after treatment by serial comprehensive eye examination supplemented with various retinal imaging and diagnostic tests.

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years of age
* visual acuity 20/100 to CF
* duration of vision loss \> 3 months
* vision loss from macular degeneration, retinitis pigmentosa, retinal vein occlusion or diabetic retinopathy
* the study eye has the worse visual acuity
* no active eye or systemic disease
* no history of macular edema or retinal/choroidal neovascularization requiring treatment within 6 months
* no significant media opacity
* no coagulopathy or other hematologic abnormality
* no concurrent immunosuppressive therapy
* able to keep follow-up for 6 months

Exclusion Criteria:

* allergy to fluorescein dye
* other concurrent retinal or optic nerve disease affecting vision