cyrilzakka/clinical-trials huggingface dataset:
A New Optical Sweat Test Method Based on a Citric Acid-derived Multi-halide Sensor

Cystic Fibrosis (CF) is a hereditary multi-system disease affecting approximately 30,000n children and adults in the USA. The diagnosis of CF requires biochemical confirmation (either abnormal sweat chloride measurement and/or identification of two CF disease causing mutations) plus clinical symptomatology. Measurements of sweat chloride remain cumbersome and although most common methodology to confirm CF diagnosis with limitations especially in young children less than 6 months of age and in areas that lack ability for the complex testing. The study objectives of this current research proposal include: A) To expand upon previously obtained pilot study data "Evaluation of a fluorescent-based chloride sensor as an optical sweat test to diagnose cystic fibrosis" B) To add the exploratory measurement of sweat Bromide as a first in human assessment observation, C) To Evaluate the development of smartphone based point-of-care technology for chloride and bromide sensor measurements, D) To further expand the class of citrate-based sensors with improved fluorescence and sensing properties for the design of new fluorescence-based analytical and diagnostic solutions based on the automated multi-halide detection system, and E) To develop point-of-care systems that can successfully integrate into clinical settings to improve current practices and facilitate early detection of disease.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years of age or older capable of providing written informed consent AND
* Patients with an established diagnosis of Cystic Fibrosis (CF) OR Healthy volunteers

Exclusion Criteria:

* Participants under medications or with disorders known to cause a positive error in the sweat test will be excluded in the study. Common causes of positive error in sweat test are mineralocorticoid hormone therapy, adrenal insufficiency, glycogen storage diseases, hypothyroidism, hypoparathyroidism, nephrogenic diabetes insipidus, G6PD deficiency or ectodermal dysplasia OR
* Any other skin or soft tissue disorders that could affect obtaining the necessary volumes of sweat.
Coping Skills Training for Symptom Management and Daily Steps (Step Up)

The aim of this study is to test the efficacy of a hybrid in-person and mHealth coping skills training and activity coaching intervention (Step Up), to enable HCT patients to effectively cope with symptoms (pain, fatigue, and stress) to improve their ability to engage in physical activity that can improve physical disability.


Eligibility Criteria:
Inclusion Criteria:

* receipt of an autologous (auto) HCT due to a hematologic malignancy, such as a diagnosis of leukemia, lymphoma, multiple myeloma
* age \>18
* self-reported fatigue, pain, and psychological distress (confirmed at recruitment) - minimum two of three symptoms reported at \>3 on 0-10 scale
* life expectancy \> 12 months

Exclusion Criteria:

* cognitive impairment (e.g., dementia) recorded in the chart or suspected by provider
* metastases to the brain
* presence of a severe psychiatric condition (e.g., psychotic disorder) that would contraindicate safe participation as indicated by the medical chart, treating oncologist, or interactions with the medical/study staff
* inability to converse in English
Rehabilitative Ultrasound Imaging: Measurements of Articular Movement of the Shoulder

The purpose of this study is to measure the amount of movement between the bones of the shoulder joint when mobilization techniques are applied by a physical therapist.

The purpose of this study is to image the articular joint movement of the glenohumeral joint utilizing ultrasound imaging (USI). Specific aims include: 1) measurement of the distance between the articular surfaces at rest; 2) measurement of the distance between the articular surfaces during manually applied glides of those surfaces; and 3) analysis of any association between the amount of glide and reported joint mobility, force application, or joint position.

Subjects will be recruited from a population of convenience. After consenting to participate, eligible subjects will complete a demographic questionnaire and pretesting of scapular and shoulder mobility. Two days of testing will be scheduled. On the first day, three grades of glenohumeral mobilization will be applied in the following directions: distraction, posterior and inferior. A handheld dynamometer will measure force; ultrasound imaging will record glenohumeral joint position. Each grade and direction will be repeated three times on the right and the left shoulder. On the second day, the mobilizations will be repeated. Measurements of humeral movement will be calculated from the ultrasound images.

Eligibility Criteria:
Inclusion Criteria:

* asymptomatic subjects with no history of neck, shoulder, or arm pain; full active pain free range of motion at the cervical spine and shoulders

Exclusion Criteria:

* neuromuscular or musculoskeletal disorders; connective tissue disorders such as rheumatoid arthritis; inflammatory conditions such as Crohns disease; Down's syndrome; Marfan's syndrome; medically diagnosed hypermobility; history of neck, shoulder or arm trauma, pain, or surgery including dislocation and rotator cuff tears; pregnancy; and metal implants
A Trial of the Urine LAM Strip Test for TB Diagnosis Amongst Hospitalized HIV-infected Patients

The novel urine LAM point-of-care strip test offers potential clinical utility to improve TB diagnosis in HIV co-infected patients. Urine LAM strip test performance improves with increasing illness severity and more advanced immunosuppression, thus offering the greatest potential utility in hospitalised HIV-infected patients with advanced immunosuppression (CD4 cell count less than 200). However, in the context of high rates of empiric treatment and the availability of other novel TB diagnostics, the clinical impact of the urine LAM strip test is unknown. This study will investigate the impact of the urine LAM strip test. The study hypothesis is that the urine LAM strip test, when combined with standard TB diagnostics (smear microscopy and culture) will significantly improve TB treatment-related outcomes (TB-related mortality, morbidity and length of hospital stay) in HIV-infected hospitalized patients when compared to standard TB diagnostics alone.


Eligibility Criteria:
Inclusion Criteria:

* HIV-infected (1x rapid HIV test positive)
* Considered TB suspect by attending doctor (must comprise at least 1 of the following: current fever or cough, drenching night sweats, self-reported LOW)
* Illness severity sufficient to warrant hospitalization
* ≥18 years old
* Provision of informed consent

Exclusion Criteria:

* HIV-uninfected
* Patients receiving any anti-TB medication in the 60 days prior to testing
* Unable to provide 30mls urine
* Inability to provide informed consent
Impact of A Mobile Game on Pediatric Nutrition and Physical Activity

Overweight and obesity in children is on the rise globally and is rapidly growing in urban India. Studies have revealed that obesity is on the rise among children in India with many of them suffering from the problem even before they reach adolescence.

As many as 30 million Indians are overweight, and obesity continues to rise. The National Family Health Survey (NFHS) found that 20% of school children are overweight. NFHS is a large-scale, multi-round survey conducted in a representative sample of households throughout India. The findings from the survey indicate that the prevalence of obesity is increasing in India along with the epidemic proportions worldwide especially in developed countries.

Overweight or obesity is the leading cause of type 2 diabetes, gestational diabetes, hypertension, osteoarthritis, various types of cancers in women like breast cancer and uterine cancer, menstrual disorder and infertility and many more diseases.

To decrease prevalence you have to decrease incidence. More and more young people are at risk of developing diseases like diabetes and if the number of children living with these diseases has to come down, focus has to be on addressing the risk factors and moving the population to a healthier lifestyle through health education/ communication and motivation. To design appropriate interventions for behaviour formation and change, we need to learn more about the underlying factors affecting these unhealthy behaviours.

This study was conducted by the Center for Communication and Change - India, in partnership with the Johns Hopkins Bloomberg School of Public Health Center for Communication Programs, and FriendsLearn (California).

Study Purpose

The specific aim of this research study is to assess the awareness levels among urban, Indian children, with respect to diet and lifestyle behaviours, while also evaluating the influence of a digital health education intervention - fooya!™ among school-age children in India. Specifically, the study objectives will be:

1. Quantify the effectiveness of a digital health education intervention- fooya (an application) on health awareness around eating right and physical activity
2. Find out the current diet and physical activity among urban, children in India and the factors that affect them
3. Assess the extent of their awareness about eating right and physical activity


Eligibility Criteria:
Inclusion Criteria:

* class (grade) 5 students

Exclusion Criteria:

* none
Longitudinal Study of Neighborhood Predictors of CVD

To examine how neighborhood-level factors interact with individual characteristics to predict incidence of cardiovascular disease and all-cause mortality.

BACKGROUND:

There are few comprehensive databases that allow for a longitudinal examination of how neighborhood-level factors may interact with individual characteristics to predict incident cases of cardiovascular disease (CVD) and all-cause mortality. This cross-institutional project joins investigators from Karolinska Institutet in Sweden and Stanford University, known for their expertise in immigrant health and social inequalities in CVD.

DESIGN NARRATIVE:

The study examines how neighborhood social characteristics (e.g., neighborhood socioeconomic status (SES), social disintegration, socioeconomic and ethnic segregation, social capital), physical environments (e.g., geocoded assets including goods and services contributing to health such as educational and recreational resources; barriers to health including pollution, industries, waste dumps, criminal activity, alcohol and fast food outlets) and individual factors (e.g., SES, cardiovascular disease {CVD} risk factors, country of birth and social networks) may interrelate to predict CVD \[morbidity and mortality\] and all-cause mortality. Data will be used from a newly created, comprehensive set of Swedish databases, MigMed and MigSALLS. MigMed (1990-2002) includes data for the entire Swedish population of 6 million women and men aged 25 and older, of whom 600,000 are first generation immigrants. Their addresses have been geocoded, yielding 9,677 neighborhoods, which will be reduced to a smaller number of defined units by cluster analyses. MigMed includes an annual assessment of individual-level sociodemographic and health indicators. Data will also be analyzed from MigSALLS (1988-2002), which includes more in-depth data from face-to-face interviews with a representative sample of approximately 18,000 women and men aged 25-74, of whom 2,000 are first generation immigrants. MigSALLS contains similar individual- and neighborhood-level factors as MigMed, as well as extensive information on factors that may mediate relationships between neighborhoods and CVD outcomes (e.g., CVD risk factors such as smoking, weight, physical activity, and blood pressure). Information from these two datasets will be matched to hospital and death records (300,000 deaths and 140,000 incidence cases of CVD expected between 1988-2002), thus creating one of the largest databases in the world involving men and women from diverse SES levels and countries of origin.

Eligibility Criteria:
No eligibility criteria
Aesthetic Outcome of Complex Linear Closure vs Second Intention Healing: Below the Knee

The purpose of this study is to determine whether complex linear closure vs second intention healing for cutaneous wounds below the knee affects esthetic outcomes (primary outcome). As secondary outcome, the study team plans to look at patient quality of life measures and complications. This will be a prospective, 2-arm, randomized, evaluator-blinded clinical trial. One half of the patients will receive repair by complex linear closure and the other half of the patients will undergo second intention healing. Three-months post-surgery, the scar will be evaluated via the patient observer scar assessment scale (POSAS), a validated scar instrument, as well as the trace-to-tape method, an objective outcome measure for linear postoperative scars. In addition, patients will be provided a validated quality of life survey to complete. Any adverse events will also be recorded.

When a cutaneous wound is created following Mohs micrographic surgery and standard excisions, a decision is made to either allow the wound to heal by second intention ("leave open") or repair the wound ("close"). The decision may depend on patient characteristics, wound location, wound size or wound characteristics.

When the decision is made to repair the wound, the majority of wounds are reconstructed using two layers of sutures: a deep (subcutaneous) layer and a top (cutaneous) layer.

This study aims to investigate whether complex linear closure versus second intention healing for cutaneous surgical procedures performed below the knee affects wound cosmesis. In other words, the study team would like to determine which of the following yields a more cosmetically appealing scar: below the knee wound that is closed in a linear fashion or below the knee wound that is left open to heal on its own. The study team also plans to look at quality of life measures via validated surveys and complications.

Randomized control trials comparing these two methods appear to be lacking. A randomized trial looked at second intention healing vs primary simple closure following 4mm or 8mm punch biopsies on the arm, back or thigh1. Besides this study, no other information could be found in the literature on randomized trials comparing linear closure vs second intent for cutaneous wounds below the knee. The study team hopes that this study will provide new insight in cutaneous surgery.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Able to give informed consent themselves
* Patient scheduled for cutaneous surgical procedure below the knee with a lesion excision diameter of at least 1 cm.
* Willing to return for follow up visit

Exclusion Criteria:

* Incarceration
* Under 18 years of age
* Pregnant Women
Effectiveness of Interactive Exergame in Older Adults With Sarcopenia

Sarcopenia has been defined as an age related, involuntary loss of skeletal muscle mass and strength. The prevalence of sarcopenia is about 10% globally, and risk factors of sarcopenia includes age, lower physical activity, and malnutrition. Sarcopenia can lead to many adverse health outcomes, particularly in physical and cognitive functions. Most of previous studies have reported that interactive exergame can improve cognitive and physical functions in older population but none of studies use of interactive exergame on older adults with sarcopenia. Therefore, the aim of study will investigate the effects of interactive exergame on older adults with sarcopenia.

A total of 60 older participants will be randomly assigned to the experimental and control groups. Participants in the experimental group will receive 40 minutes per session, 2 times a week for 12 weeks interactive exergame while those in the control group will maintain their regular activity. All participants will be assessed their physical and cognitive function, sarcopenia index and other health related outcome measurements before and after intervention program.

Eligibility Criteria:
Inclusion Criteria:

1. 65-99 years old
2. able to walk 6 meters without assistance devices
3. older adults with possible sarcopenia, sarcopenia or severe sarcopenia

Exclusion Criteria:

1. people with hemodialysis
2. people with built-in electronic medical equipment
3. people with central nervous system disease such as stroke or Parkinson's disease
4. score in ascertain dementia 8 more than 2
5. people with mental illness
Study of U101 for Bladder Pain and/or Urgency

The purpose of this study is to determine whether intravesical U101 (alkalinized lidocaine-heparin) treatment reduces the symptoms of pelvic pain and/or urgency of bladder origin.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects at least 18 years of age.
* Subjects must have given written informed consent to participate in this trial.
* All female subjects, except those who are post-menopausal and/or surgically sterilized, must consent to use two medically acceptable methods of contraception throughout the entire study period. Medically acceptable methods of contraception that may be used by the subject and/or her partner include: abstinence, birth control pills, diaphragm with spermicide, intrauterine device (IUD), condom and foam, vaginal spermicidal suppository, progestin implant, and Depo-Provera injections.
* Subjects must have had symptoms of pelvic pain and/or urgency.
* Medical history and physical examination results must be clinically acceptable to the Investigator. Medical Monitor may evaluate subjects who don't meet eligibility criteria.
* Female subjects currently using hormone therapy (HT) must have been using HT for at least 3 months.

Exclusion Criteria:

* Subjects less than 18 years of age.
* Subjects with known hypersensitivity to heparin or lidocaine.
* Female subjects who have a positive pregnancy test at the time of screening, who are pregnant or lactating, or who are planning to become pregnant during the study period.
* Subjects who are chronic users of narcotics or who are using any narcotics at the time of study entry.
* Subjects who have hepatic disease or clinically significant abnormal liver function tests (more than twice the upper limit of the normal range).
* Subjects who do not expect to be available for the entire duration of the study.
* Subjects with any coexisting significant medical condition that is likely to interfere with study procedures (cardiovascular, hematological, central nervous system, pulmonary, renal, etc.)
* Subjects who have been treated with dimethyl sulfoxide (DMSO) or other bladder instillation therapies within three months prior to study entry.
* Subjects who have had cystoscopic dilatation of their bladder or urethra within three months of study entry.
* Subjects who have taken or used any investigational drug or device within 30 days before the start of the study, or who are currently enrolled in another investigational study.
* Subjects contemplating having or scheduled for any invasive surgical procedures during the study period.
* Subjects who are unwilling or unable to abide by the requirements of the study.
* History of gastrointestinal (GI) bleeding
* Active bleeding from any source
* Screening activated partial thromboplastin time (aPTT) above normal limits
* Systolic blood pressure (BP) \> 180 mmHg or \< 90 mmHg at Screening.
* Subjects with an actively bleeding lesion/area in the bladder as detected by urinalysis
Calypso-based Deep Inspiration Breath Hold (DIBH) Radiation Treatments of Lung Cancer

The purpose of this study is to test the use of Calypso beacon implants as a way to determine where the lung tumor is located during radiation treatment. The Calypso beacons are small devices that are implanted in the lungs, near the tumor. They are able to send a signal to a tracking system to show where they are, and where the tumor is, as the patient holds their breath for the radiation treatment. The investigators want to find out what effects, good and/or bad, that this has on the patient and the way they treat the cancer in your lungs.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologic proof of malignancy suitable for thoracic radiation therapy
* Patients planning to undergo radiation therapy for primary or recurrent malignancy of the lung or metastatic malignancy to the lung.
* Age ≥ 18 years old
* KPS ≥ 60%
* Ability to hold their breath for \>20 seconds for 5 times
* Patients who are able to tolerate flexible bronchoscopy
* Patients with life expectancy of at least 12 months
* Patients able to have bronchoscopic placement of Calypso as confirmed on a recent (within the past 8 weeks) CT scan.
* Patients who are able to comply with the protocol follow-up schedule.

Exclusion Criteria:

* Patients unable to comply with instructions for DIBH
* Patients with implants in the chest region that contain metal or conductive materials (e.g., metal implants, rods, or plates) which Calypso Medical considers will interfere with the Calypso System's electromagnetic localization.
* Patients with active implanted devices, such as pacemakers, defibrillators, and drug infusion pumps since the effects of the Calypso System operation on these devices are unknown.
* Patients with clinically significant active infections.
* Patients with bronchiectasis in the region of the intended implantation sites.
* Patients with a history of hypersensitivity to nickel.
* Patients whose lung tumors are being monitored with MR imaging (MR imaging of the anchored transponders is safe but yields an image artifact around the anchored transponders).
* Posterior lesions that would be \>19cm distance from Calypso detector plate. Patients may be treated in the prone position in order to meet the required minimum distance.
* Patients with any other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in this clinical study.
* Patients who are deemed unable to safely undergo or tolerate flexible bronchoscopy
* Patients who are unable to tolerate anesthesia or sedation
* Patients enrolled in any other clinical studies the investigator believes to be in conflict with this investigation.
* Female patients who are pregnant or nursing