cyrilzakka/clinical-trials huggingface dataset:
Validation of a Personal Breath Analyzer for Diet and Energy Expenditure Assessment and Management

The purpose of the research is to determine energy expenditure rates and diet and/ physical activity metabolic features of an individual using current state technologies and a new technology created at the Center for Bioelectronics and Biosensors at ASU. This is a pilot study which intent is to validate this device for use in the weight loss patient population.

This study will involve research of metabolic physiological parameters that are measured through the breath of the individuals, together with other physical parameters (weight, height, date of birth, fat and lean body composition via bio-impedance, heart rate, blood pressure, and breathing rate) assessed in the clinic, and a questionnaire about diary physical activities. The study will involve withdrawn of breath samples at resting conditions, and under diets or physical activities regimes.

This instrument will assist our patients in terms of tailoring their diet/nutrition through their weight loss journey prior and after surgery. As a new technology, it will be an excellent tool for compliance assessment and engagement with the Weight Loss Program as well as for long term follow up.

The Breezing® device is a new technology locally invented in the state of Arizona that uses a sensor cartridge and a flow meter to determine the rate of consumed oxygen and produced carbon dioxide in the breath. The sensing technology of the new indirect calorimeter, which used a cell-phone camera as the optical detector. The current Breezing® device uses a code to carry calibration parameters of a single-use sensor cartridge, which can be scanned and recognized by the mobile application (app). The device is 6.0 oz. (170 g), and 1.8 in × 2.1 in × 4.8 in (4.7 cm × 5.4 cm × 12.3 cm), and connects wirelessly to an iOS mobile device, using Bluetooth 4.0 technology.

The mobile device (phone or tablet) receives data from the device, processes information, and then provides test results and summaries through a graphic user interface. It determines the energy expenditure from the measurement of VO2 and VCO2 according to the Weir equation, along with RQ. In addition to the sensor cartridge, the Breezing® device is used with a non-rebreathing 2-valvesmouthpiece.

This new device will provide a more precise information regarding metabolic rate in our Bariatric Patients to better tailor their preoperative diet and monitor their weight loss.

Up to date, this device was never used or validated before in the Bariatric population under this setting.

Eligibility Criteria:
Inclusion Criteria:

* Females or Males between 18 and 50 yo
* Class II and Class III Obesity (BMI 35 and above)

Exclusion Criteria:

- No Obesity. Patients with normal BMI
Spine of Caregivers of Children with Cerebral Palsy

The purpose of this study was to assess pain (rest, activity, and night pain using the Visual Analog Scale), disability (neck using the Neck Disability Index; lumbar using the Oswestry Disability Index), and curvature (cervical, thoracic, and lumbar using the Spinal Mouse) in primary caregivers of children with cerebral palsy.


Eligibility Criteria:
Inclusion Criteria:

* Primary caregiver between the ages of 25-54
* Has a child diagnosed with Cerebral Palsy between the ages of 0-18
* Does not have inflammatory pain
* Without pain originating from abdominal-pelvic organs
* Volunteer caregivers were included

Exclusion Criteria:

* Having acute fracture and malignancy
* Had a surgical operation (related to spine disorders)
* Having a care burden for more than one disabled individual
* Caregivers with chronic illnesses (such as neurological, psychological disorders) were excluded
Correlation Between Duration of Fasting and Response to Fluid Replenishment, Evaluated With Repeated Measures of VTI.

The investigators will study the correlation between the lenght of the fasting before surgery and the need to replenish with intra-venous fluids in children, evaluated with 3 measures of the aortic Integral Time Velocity with transthoracic echocardiography.


Eligibility Criteria:
Inclusion Criteria:

* Children aged between 3 and 6 years with a normal ponderal evolution.
* Children with good general status (ASA 1)
* Children whose parents have given the informed authorization to do the study.
* Children seen in the consultation of anesthesiology.
* Children programed to have ambulatory surgery (Amygdalectomy, dental care, dental extraction).

Exclusion Criteria:

* Children with more than 6 years of age.
* Children whose parents didn't agree with the study.
* Children enrolled in another study on the 3 months before.
* Children with hearth or lung conditions.
LiquiBand Versus Dermabond Versus Sutures for Closure of Surgical Wounds

To evaluate the cosmetic outcome, effectiveness, user and subject satisfaction, and safety of LiquiBand® Flex in relation to DermaBond Advanced™ and conventional sutures for the topical closure of surgical wounds.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female aged 18 or older on day of enrollment
* Scheduled for surgical procedure by a delegated study surgeon
* Fresh surgical wound with evenly distributed tension over length of incision
* Willing and able to sign informed consent
* Agree to return for 2 week (+/- 7 days) and 3 month (90 days +/- 7 days) post-procedure follow-up visit

Exclusion Criteria:

* Known sensitivity to cyanoacrylates, formaldehyde or acetone products
* Wounds in which incision edges are under high tension or not easily apposed (after deep layer suture), or over joints (unless immobilized)
* Wounds less than 15mm in length
* Wounds in which haemostasis is not able to be achieved, eg, drain is placed or Warfarin level \>2.5 prior to surgery
* Wounds in which deep closure could not be achieved
* Surgical procedures involving mucus membranes or eyes
* Mental incapacity, dementia, or inability to give informed consent
* Pregnant or nursing
* Disease related or pharmacologically immuno-compromised
Evaluation of a Brief, Online Intervention for Military Personnel

This randomized controlled trial will compare the effectiveness and acceptability of a computerized treatment targeting anxiety sensitivity compared to an active control: Physical Health Education Treatment (PHET) to determine efficacy among military personnel when delivered over the Internet.

Purpose: To investigate the efficacy and acceptability of a computerized stress sensitivity treatment delivered online among a population of U.S. military personnel.

The objective of the current proposal is to evaluate the efficacy of the Cognitive Anxiety Sensitivity Treatment (CAST) program in an online RCT through Amazon's Mechanical Turk with Veterans and military personnel. The primary outcome variables will be traumatic stress, anxiety, and depressive symptoms. The study is being conducted at Florida State University.

Specific Aims: (1) Evaluate the efficacy of the CAST program delivered over the Internet among Veterans and military personnel; (2) Assess acceptability and usability of the CAST program delivered over the Internet without in person appointments; (3) Determine the feasibility of using Amazon's Mechanical Turk to recruit and conduct a fully online randomized controlled trial of a computerized treatment.

Veterans or active duty personnel (N = 100) who are at increased risk for mental health problems, as indicated by elevated anxiety sensitivity, will be recruited through Amazon's Mechanical Turk. Mechanical Turk is an online marketplace for individuals interested in completing computerized tasks, such as research surveys, for compensation. Participants will complete self-report symptom measures before and after the intervention as well as at a 4-month follow-up appointment. The intervention is a single session and lasts approximately 45 minutes. The intervention contains educational material to dispel commonly held false beliefs about the dangerousness of experiencing anxiety symptoms, for example elevated heart rate or a difficulty concentrating. Then participants are guided through an exercise designed to bring on these uncomfortable bodily sensations to help participants reduce the amount of distress these symptoms cause. Participants will also be asked to provide feedback related to acceptability and usability of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* current or past member of the U.S. military
* elevated anxiety sensitivity as indexed by ASI-3 cognitive concerns subscale

Exclusion Criteria:

* none
Effect of Tactile and Kinesthetic Stimulation on Very Low Birth Weight Preterm Infants

Two groups of preterm infants with birth weight equal to or less than 1500 grams will be studied. One group will receive the standard care and the other will receive standard care plus maternal special tactile stimulation. Gain of weight, length and head circumference, date of the beginning of enteral feedings, length of time to recover birth weight and age of hospital discharge will be recorded and compared between both groups.

Preterm infants birth weight equal or less than 1500 grams and gestational age equal or less than 32 weeks will be randomized in two groups: standard care that will receive the usual treatment applied to all infants admitted to our unit and a second groups that will receive standard care plus maternal tactile and kinesthetic stimuli that will be taught to the mothers. Randomization will be performed among those that accept to participate in the study. Growth (birth, length and head circumference), age of life to start receiving enteral feedings, length of hospital stay, time to recover birth weight will be recorded and compared between both groups.

Eligibility Criteria:
Inclusion Criteria:

* Preterm newborns with birth weight equal to or less than 1500 grams and gestational age equal to or less than 32 weeks.
* Mother willing to participate in study.

Exclusion Criteria:

* Major congenital malformations
* Congenital infectious diseases
* Mother not willing to participate in study
Patient Recall of Cancer Screening and Diagnosis

The purpose of this research is to try to better understand how much information relating to cancer screening and diagnoses that people can recall on their own and to better understand how to help people get better information. In this study, investigators will see if giving time or other resources help individuals remember more and more accurate details about their cancer screening and care.

This is a randomized controlled trial of an intervention to encourage use of online medical records for filling out a cancer screening, diagnosis and treatment questionnaire. Participants will be asked to self-report on cancer screening and treatment. They will then be asked the same questions again a week later.

The control group will have had one week to reflect on the questions, and investigators anticipate some influence of this on responses. The intervention group will be prompted about accessing their medical records from the major local health systems online, with links to directions provided by each hospital system. They will then be asked to fill out the same questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with breast or prostate cancer within the last 10 years
* have access to the internet with a working email address
* reside in Northeast Ohio

Exclusion Criteria:

-
Physiotherapy Following Disc Surgery: Long Term Follow-up of a RCT

Hitherto no comprehensive long-term follow-up data of 10 years and more have been obtained from survivors of disc surgery that would have considered the type of postoperative care.

Objectives: 1) To evaluate the long-term effects of postoperative comprehensive physiotherapy starting 1 week after lumbar disc surgery. 2) To assess the relative risk of segmental instability in the operated segment 12 years following lumbar disc surgery.

Design: Twelve years' follow-up of a three-armed, randomized, controlled, single blinded clinical trial. Setting: Outpatient department of Physical Medicine \& Rehabilitation. Participants: Of 120 patients following first-time, uncomplicated lumbar disc surgery who participated in the original study are invited to a 12 years follow-up examination. Interventions: In the original study, patients had been randomly assigned to "comprehensive physiotherapy", "sham intervention" (neck massage), or no therapy. Measurements: Low Back Pain Rating Score (LBPRS; Manniche 1993), functional X-rays of the lumbar spine. All data are collected by blinded students and physicians at the Department of PM\&R, Vienna Medical University.

Eligibility Criteria:
Inclusion Criteria:

* all patients who had undergone a first time uncomplicated disc surgery for lumbar vertebral disc herniation who had taken part in the original RCT and had completed the treatment originally allocated
* all patients who had undergone a first time uncomplicated disc surgery for lumbar vertebral disc herniation who had taken part in the original RCT and had not completed the treatment originally allocated

Exclusion Criteria:

* n.a.
Vinegar-induced Collection of Duodenal Pancreatic Juice Via Endoscopic Ultrasound

The goal of this clinical trial is to learn about the feasibility of collecting pancreatic juice through duodenal aspiration by ultrasound endoscopy (EUS) for molecular marker testing after intraduodenal infusion of vinegar in patients with suspected pancreatic cancer and who are scheduled to have endoscopic ultrasound with fine needle aspiration (EUS-FNA). The main questions it aims to answer are:

* Is vinegar-induced collection of duodenal pancreatic juice via endoscopic ultrasound feasible?
* What is the best operating condition (amount of vinegar, collection time, etc.) of vinegar-induced collection of duodenal pancreatic juice via endoscopic ultrasound?

Participants will have EUS as scheduled, during which different amount of vinegar will be infused into duodenum and then pancreatic juice be collected for different time via suction by EUS.

Researchers will compare the amount of collected pancreatic juice and molecular marker level in different groups to determine the best operating condition for vinegar-induced collection of duodenal pancreatic juice via endoscopic ultrasound.

This is a single center, prospective, randomized-controlled study. Participants who are diagnosed as suspected pancreatic cancer and are schedule to have EUS-FNA will have saline or different amount of vinegar infused into duodenum and pancreatic juiced collected via EUS suction during different period of time under intravenous anesthesia.

The collected pancreatic juice will be weighed instantly and frozen in 10 minutes under -80℃ for further tests.

Researchers will compare the weight, cfDNA (cell free DNA) concentration, PLA2G1B (Phosphatidylcholine 2-acylhydrolase 1B) concentration, immunoglobulin concentration and KRAS (Kirsten rat sarcoma viral oncogene) mutation load of collected pancreatic juice from different arms.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 years old or older
* Diagnosis: CT, MRI, transabdominal ultrasound or other imaging examinations showed a pancreatic mass, and 3 endoscopists agreed on the diagnosis of suspected pancreatic cancer
* EUS-FNA is required to perform further treatment strategy
* The patient can understand the study protocol, is willing to participate in the study and can provide written informed consent

Exclusion Criteria:

* The patient's clinical and imaging features do not support the diagnosis of suspected pancreatic cancer, judged by 3 endoscopists
* The patient refuses to have EUS-FNA
* The patient is unsuitable for EUS-FNA because of his/her general condition, or contraindicated for anesthesia
* The patient's imaging suggests severe pancreatic duct obstruction
* The patient cannot understand the conditions and objectives of this study, or refuse to participate in the study
Deep Brain Stimulation for Treatment Resistant Depression

This study will investigate the safety and efficacy of deep brain stimulation (DBS) in lateral habenula (LH) for patients with treatment-resistant depression.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70, regardless of gender;
2. Diagnostic And Statistical Manual Of Mental Disorders 5th Ed (DSM-V), for Psychiatrists' Examination of Severe Depressive Disorders;
3. Same diagnostic conclusions based on DSM-V made by two independent psychiatrists;
4. A minimum of 24 months of depressive history, over 2 or more adequate antidepressant trials with Hamilton Depression Rating Scale (HAMD) reduction rate ≤20% (including MECT) ;
5. HAMD-17 scores ⩾ 20 at screening;
6. Functional General Assessment Table (GAF) rating ≤50;
7. Able to comply with the operational and administrative requirements of participation in the study, and able to give written informed consent.

Exclusion Criteria:

1. Patients with severe or unstable mental, liver, kidney, endocrine, hematological diseases, or those with psychotic co-morbidities, including personality disorders;
2. History of substance abuse in the past 12 months; history of epilepsy, or febrile seizure in childhood;
3. Patients who have attempted suicide within the past 6 months, or have had a secondary suicide attempt within the past 2 years;
4. Women who are breastfeeding, pregnant, or intend to be pregnant during the clinical study;
5. Any surgical contraindications to undergoing deep brain stimulation (DBS);
6. Patients who cannot give full informed consent.
Tear Osmolarity Over Time With Artificial Tears

The effect of artificial tears on tear osmolarity

Tear osmolarity measures the amount of solutes in the human tear film. The higher the reading, the more likely the patient has dry eyes. Some say it has "potential to be the gold standard" of dry eye testing. The investigators study the tear osmolarity at different time points after instillation of artificial tears.

Eligibility Criteria:
Inclusion Criteria:

Between the ages of 18 and over inclusive. Males or females Any race or ethnic background Patient is in generally good \& stable overall health. Patient likely to comply with study guidelines \& study visits. Informed consent signed. Subjective evaluation of symptom of dryness (SESoD): Score 2 (Mild)

-

Exclusion Criteria:

Corneal refractive surgery within 6 months of this study. Intra-ocular surgery within 6 months or ocular laser surgery within 6 months. Pregnant or lactating women. Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.

Corneal staining Grade 3 or higher No Restasis for past 3 months Discontinue topical medications for at least 1 week
Diffusion Study on Patients With Osteosarcoma

The aim of the study is to assess the accuracy of dynamic contrast enhanced and diffusion-weighted MR Imaging in evaluating response to chemotherapy in osteosarcoma.

Dynamic contrast-enhanced and diffusion-weighted magnetic resonance imaging have the potential to measure early cellular and vascular changes that occur in response to chemotherapy and could therefore be early predictors of therapeutic response.

Aim of our study is to assess the accuracy of dynamic contrast enhanced and diffusion-weighted MR imaging in evaluating response to chemotherapy during the preoperative treatment of osteosarcoma. Patients will undergo dynamic contrast-enhanced and diffusion-weighted magnetic resonance imaging before, during and after chemotherapy.

Our long-term goal is to use these imaging techniques to develop non-invasive methodologies that would be better predictors of tumor response than the current clinical standard and earlier predictors than histological evaluation of the whole tumor.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of osteosarcoma of all entities
* Written informed consent of patient

Exclusion Criteria:

* No written informed consent
* Contraindications to MRI (pacemaker, aneurysm clip, mechanical and/or electrical device or metallic fragment, severe claustrophobia)
* Severe, active co-morbidity
* Major medical illnesses or psychiatric impairments
Stimulating Deep Brain Regions With a Magnetic Stimulator

The purpose of this study is to determine whether a special coil designed for magnetic stimulation of areas deep in the brain can affect mood and emotion in healthy volunteers. Researchers hope to better understand how the brain controls mood and motivation and what goes wrong with this process in disease.

For transcranial magnetic stimulation (TMS), a wire coil is held over the scalp. A brief electrical current passes through the coil and creates a magnetic pulse that stimulates the brain.

Eighteen participants, 9 men and 9 women, will be enrolled in this study. They will be assigned to one or both of the following two experiments.

Experiment 1

In this experiment, researchers will test the effectiveness of a new type of wire coil. They will deliver magnetic impulses of varying strength. Approximately 150 stimulations will be given over of about 20 minutes. To determine whether the coil causes any problem with hearing, participants will undergo a hearing test immediately before and after the experiment.

Experiment 2

This experiment, which has two parts, is designed to determine whether TMS can affect mood. In the first part, participants will be asked to report any changes in mood before, during and after the magnetic stimulation. In the second part, they will be asked to choose between sets of 2 identical pictures-choosing one will result in full magnetic stimulation, choosing the other will result in stimulation at 10 percent of full intensity.

Participants will be compensated up to $100 for their involvement in this study.

Current magnetic stimulation techniques permit only superficial stimulation of brain, but for some purposes deeper stimulation would be helpful. The purpose of this study is to determine whether a special coil designed for magnetic stimulation of deep brain regions can affect mood and emotion in healthy human volunteers. The special coil was designed to stimulate neuronal pathways related to the control of motivation and reward, specifically, fibers connecting the cingulated or prefrontal cortex with the nucleus accumbens. Computerized theoretical calculations were made in order to optimize the coil design for maximizing the percentage of stimulation in depth relative to the cortical regions. The present study will look first at the influence of the coil on the response from motor cortex. Should there be good evidence the coil can truly be more effective in stimulating deep structures, then we will explore whether it can indeed affect mood and emotion when single pulses are applied.

Eligibility Criteria:
INCLUSION CRITERIA:

The study is planned for adult subjects with normal neurologic and psychiatric examinations.

Healthy male and female volunteers will be included in this protocol.

EXCLUSION CRITERIA:

History of surgery with metallic implants or known history of metallic particles in the eye, cardiac pacemaker, neurostimulators, cochlear implants, history of drug abuse, psychiatric illness, hypertension, or concurrent medication.

Children are also excluded.