cyrilzakka/clinical-trials huggingface dataset:
The Effects of Healthy Beat Acupunch on Physical Fitness of Thai Older Adults in Residential Homes

The purpose of this study is to test the effects of the first three months of instructor-led HBA regimen on physical fitness (aerobic endurance, lung capacity, upper body flexibility, lower body flexibility, handgrip strength, upper body strength, and lower body strength) between the HBA intervention and control groups, to test the effects of another three months of DVD-led HBA regimen followed by the three months of instructor-led on physical fitness between the HBA intervention and control groups and to test the changes at three and six months of the HBA regimen in comparison to the baseline of the physical fitness in the HBA intervention group.

After the researcher meet the potential participants regarding the inclusion criteria, the researcher will inform purpose of study, human subjects protection, and termination in this study. Once participants receive all information and need to participate in this study, the researcher will ask permission participants to sign in their names in the informed consent and participant information sheet. If participants cannot sign their names, a thumbprint will be used instead of signatures. Therefore, the consent form will be completed by signatures or thumbprints.

This study will conduct in group exercise. The intervention group will receive the HBA program, 40 min/time, 3 times/week for 6 months. The control group will continue their routine activities of the residential homes.

Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate dependence or complete independence as defined by an Activity Daily Living assessment using the Barthel Index (BI Thai version) with a score of 61 or higher
* No cognitive impairment defined by a Short Portable Mental Status Questionnaire (SPMSQ Thai version) a score of ≥ 8
* No experience with the HBA regimen
* Able to communicate in Thai

Exclusion Criteria:

* Older adults whom physicians have advised not to exercise because of medical conditions, severe disease, such as severe cardiopulmonary disease (CVD, COPD), or severe musculoskeletal diseases, and have sensory impairments such as visual and auditory impairments.
KINO-DYSPNEA: Validation of Kinocardiography to Distinguish Dyspnea of Cardiac Origin From Others

Seismocardiography (SCG) measures the thoracic vibrations caused by the cardiac contraction and ejection of blood into the great vessels. Current smartphones with gyroscopes and accelerometers can measure these vibrations. Based on these components we measure and quantify the cardiac kinetic energy (kinocardiography) in order to differentiate dyspnea of cardiac origin from dyspnea of other origin. The study is conducted in an emergency service where a smartphone performs the measurement during 3 minutes. The results of the kinocardiography-based classification are then compared to the final diagnosis made by a physician. Currently, 235 patients have been included in the clinical study since May 2022. This rapid and non-invasive measurement allows the aid-to-diagnosis of heart failure without being influenced by other factors like the renal function for example that can be NT-pro BNP blood marker.


Eligibility Criteria:
Inclusion Criteria:

* Dyspnea.
* Adults aged above 18 years old.

Exclusion Criteria:

* Patients younger than 18 years old.
Validation of [18F]FES for Imaging of Brain Estrogen Receptors

Validation of \[18F\]-FES for imaging of estrogen receptors in the brain

The primary objective of the study is to determine if \[18F\]-FES Positron Emission Tomography (PET) can be used to quantify the estrogen receptor expression in the human brain.

Estrogens are the primary female sex hormones that play a major role in the development and maintenance of secondary sexual functions. In addition, estrogens play an important role in cardiovascular, musculoskeletal, immunological, bone development and central nervous system processes. Actions of estrogens are mediated by a group of specialized receptors, known as estrogen receptors. Estrogens were found to be neuroprotective and may thus protect against development of neurodegenerative disorders like Alzheimer's disease, Parkinson's disease and multiple sclerosis. In addition, estrogens may also play an important role in psychiatric disorders, like depression. To improve our understanding of the action of estrogens in the brain, it is important to study the expression of estrogen receptors in the brain. Positron emission tomography (PET) is the most suitable technique for non-invasive imaging of brain receptors. \[18F\]FES is a PET tracer that is regularly used in the UMCG to image the estrogen receptor expression in breast cancer patients, but has never been used for quantitative imaging of brain estrogen receptors. Quantification of the expression of brain receptors by PET usually requires arterial blood sampling to obtain the plasma input function of the tracer. Arterial blood sampling causes discomfort to the patient and therefore can be an obstacle especially in longitudinal studies. The aim of this study is therefore to investigate whether \[18F\]FES PET imaging for quantification of estrogen receptors in the human brain is feasible without arterial blood sampling, using a reference tissue model (SRTM) or an image derived input function (IDIF), so the discomfort associated with arterial blood sampling can be avoided.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age \> 18 years
* For postmenopausal women: at least 1 year after menopause
* For premenopausal women: a regular menstruation
* Signed written informed consent

Exclusion Criteria:

* Use of estrogen receptor ligands, such as tamoxifen or fulvestrant
* History of ER-positive malignancies or breast cancer
* Use of any contraceptive drugs (pill, injections or implanted)
* For postmenopausal women: (history of) estrogen replacement therapy
* Pregnancy
* History of removal of the ovaries and/or the uterus
* Current systemic diseases
* Major metabolic diseases (e.g. diabetes, hyper- or hypothyroidism)
* Somatic, organic or neurological disorders
* Recent participation in a scientific research study (\<1 year) involving radiation
* Claustrophobia
* Presence of materials in the body that can be magnetized, like: pacemaker, metallic implants/prostheses, metal fragments, shunts, artificial heart valves, vascular clips, fixed hearing aid, tattoos containing metal, hair implants, artificial dentures
Effects of the Mindful Self-Compassion (MSC) Program

The efficacy of the Mindfulness Based Stress Reduction (MBSR) program has been widely researched. However, research on the efficacy of a standardized program, specifically focused on self-compassion skills, such as the Mindful Self-Compassion (MSC) program remains scarce. Moreover, the use of long-term follow-ups and the analysis of regular practice of mindfulness and self-compassion over time to identify possible changes in inflammatory activity and in biomarkers associated with diseases has been even less analysed and represent a gap in this area. In this context, a main hypothesis is proposed: MSC training and the subsequent regular practice will contribute to improve mental health, self-reported health status, psychological wellbeing and health-related biomarkers. This research uses a RCT design to analyse our main hypothesis. Our RCT design includes three conditions, i.e. MSC group compared to a well-established protocol MBSR training group and to a waitlist control group (CG), and four moments of measure, i.e. pre- and post-training, 6-month, and 12-month follow-ups. Participants in the experimental conditions will receive, respectively, the MSC and MBSR 8-week trainings and afterwards they will go on with weekly MSC/MBSR guided practices over a 12-month period. In addition to an analysis of the relative efficacy of MSC compared to MBSR and CG, we will also study the mechanisms involved in the efficacy of MSC training.


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals
* Not having previous experience in mindfulness and/or self-compassion practices.

Exclusion Criteria:

* Having suffered or currently suffer from a psychiatric disorder, being in psychiatric or psychological treatment,
* Suffering from a severe medical disorder that could affect inflammatory response, as well as systemic inflammation (cancer, AIDS or any other chronic disease that occurs with inflammation, including COVID-19).
* Having received psychotropic medication within 2 weeks prior to blood extractions (as it interferes with the immune and neuroendocrine systems), or having signs of acute infection on the day of the blood extraction.
* The influence of variables that may affect some of the biomarkers (e.g., time of sample collection, seasonality, BMI, diet, omega-3, vitamin D, nutritional supplements, etc.) will also be taken into account.
Ambulatory Interdisciplinary Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD)

This randomised-controlled study is undertaken to investigate the effects of a long term low intensity outpatient training program on physical fitness and quality of life in moderate to severe COPD patients.

Broad evidence exists on the beneficial effects of pulmonary rehabilitation on exercise capabilities and quality of life in COPD patients. Clinically relevant effects have been achieved by training programs of differing design regarding setting (inpatient vs. outpatient vs. home-based), duration (short-term vs. long-term) and intensity (high vs. low intensity).

While there is sufficient evidence to propose pulmonary rehabilitation its use is generally low in clinical practice. One reason may be that it is unlikely that costly programs are offered to a significant proportion of eligible patients. The ideal training program will therefore at the same time accomplish the greatest improvements regarding physical capabilities and quality of life and sustain them for the longest period at the lowest cost.

The purpose of the present study is to evaluate whether a continuous, low-intensity, low-cost, physiotherapist-led outpatient pulmonary rehabilitation program is a able to achieve significant long-term improvements of exercise tolerance and quality of life in moderate to severe COPD patients at a lower cost level than previously published programs.

Eligibility Criteria:
Inclusion Criteria:

* COPD GOLD stage II-IV
* smoking history of \>20 pack years
* adequate pharmacological therapy
* written informed consent

Exclusion Criteria:

* respiratory insufficiency, defined as PaO2\<55 mm Hg and/or PaCO2\>50 mm Hg breathing room air
* manifest cardiac insufficiency
* uncontrolled arterial hypertension
* malignant disease
* symptomatic coronary heart disease resp. pathological cycle ergometry results
* limited physical capabilities caused by musculoskeletal disorders
* unwillingness to return for follow-up
* previous or ongoing participation in exercise training programs
* unability to attend at least 75% of sessions
Interventional Study of Vosoritide for the Treatment of Children with Hypochondroplasia

The intent and design of this Phase 3 study is to assess vosoritide as a therapeutic option for the treatment of children with hypochondroplasia (HCH).

This is a Phase 3 randomized, stratified, placebo-controlled, double-blind multicenter study to evaluate the effect of 52 weeks of daily vosoritide administration on annualized growth velocity (AGV) in participants with HCH. Eligible participants with documented HCH confirmed by genetic testing will roll over from Study 111-902 and enter the 111-303 study. Participants will be randomly assigned to one of two treatment groups: Placebo or Vosoritide. The route of administration is subcutaneous injection, and the frequency of administration is daily.

Eligibility Criteria:
Inclusion Criteria:

1. Participants must be ≥ 3 to \< 18 years of age at enrollment
2. A confirmed genetic diagnosis of HCH
3. A height Z score of ≤ - 2.0 standard deviations (SDs) in reference to the general population of the same age and sex, as calculated using the Center for Disease Control and Prevention (CDC) growth charts
4. Males and females are eligible to participate in this clinical study.
5. Females ≥ 10 years old or who have begun menses must have a negative pregnancy test at the Screening Visit and be willing to have additional pregnancy tests during the study.
6. If sexually active, participants must be willing to use a highly effective method of contraception while participating in the study.

Exclusion Criteria:

1. Short stature condition other than HCH
2. Have an unstable condition likely to require surgical intervention during the study.
3. Evidence of decreased growth velocity and/or growth plate closure
4. Taking any of the prohibited medications
5. Treated with growth hormone, insulin-like growth factor 1 (IGF-1), or anabolic steroids
6. Planned or expected to have limb-lengthening surgery during the study period.
7. Planned or expected bone-related surgery (ie, surgery involving disruption of bone cortex, excluding tooth extraction), during the study period
8. Require any investigational agent prior to completion of study period.
9. Received vosoritide or another investigational product or investigational medical device in the past
10. Have used any investigational product or investigational medical device for the treatment of HCH or short stature at any time, including vosoritide
11. Have current malignancy, history of malignancy, or currently under work-up for suspected malignancy.
12. Have known hypersensitivity to vosoritide or its excipients.
13. Concurrent disease or condition that, in the view of the investigator, would interfere with study participation or safety evaluations, for any reason.
Health Coaching: A Pilot Trial Among Reintegrating Veterans

Health coaches help people focus on goals, identify strengths and values, and work towards building the life they wish to live. Health coaching may be especially helpful for people navigating a life transition, such as Veterans who recently separated from military service (i.e., reintegrating Veterans). In this pilot trial the investigators will 1) examine the feasibility of study procedures and acceptability of health coaching among reintegrating Veterans, 2) evaluate measures for suitability in a future trial that will examine efficacy of the intervention, 3) determine barriers and facilitators to implementing the intervention among reintegrating Veterans.

This pilot study is designed to provide data to inform the design and procedures of a future efficacy trial of health coaching among reintegrating Veterans. An enrollment rate 30% and an assessment completion rate 65% at 9 months will be considered feasible enrollment and assessment completion rates for a future efficacy trial. An intervention completion rate 70% and mean score 27 on the Client Satisfaction Questionnaire-8 will indicate acceptability. Evaluation of measures will entail quantifying the mean levels in this population, characterizing typical variation in the outcomes, descriptive analyses of within-person change across time, and adjusted estimates of treatment effect sizes with 95% confidence intervals to calibrate the sample size needs of a fully powered trial. Qualitative interviews with participants will provide information on barriers and facilitators to implementation as well as perceived benefits and potential harms.

Eligibility Criteria:
Inclusion Criteria:

* United States military Veterans recently separated from service

Exclusion Criteria:

* Currently living in an institution (e.g., nursing home, prison)
* Cognitive impairment as indicated by a score equal to or greater than 10 on the Short Blessed Test
* Currently experiencing psychosis as indicated by endorsing thought interference or hallucinations on the Psychosis Screening Questionnaire
* At acute risk for suicide as indicated by the P4 screener
* Unable to read or understand English
Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension

Primary aldosteronism (PA) is common but rarely recognized cause of hypertension that carries excess cardiovascular and renal risk and has approved targeted treatments. Despite current clinical guidelines that recommend screening in a defined set of high-risk populations, less than 5% of eligible patients are ever screened for PA. This study aims to evaluate the impact of a computer decision support Best Practice Advisory (BPA) alert on rates of screening for PA in guideline-eligible patients, referral to specialist PA care, and treatment with mineralocorticoid receptor antagonists.

The study protocol is a single-center Quality Improvement initiative performed as a cluster-randomized controlled trial designed to evaluate the impact of an EPIC electronic health record Best Practice Advisory (BPA) alert on rates of screening for PA in guideline-eligible patients. 1600 patients meeting inclusion/exclusion criteria for Primary Aldosteronism (PA) screening will comprise the study population, with randomization of alert/no alert occurring at the level of their treating clinician (Attending Physician, Nurse Practitioner, or Physician Assistant) to minimize spillover/contamination effects of the BPA onto other patients treated by the same clinician. Treating clinicians within primary care and relevant specialties including endocrinology, nephrology, and cardiology will be randomized 1:1 to receive or not receive a BPA prompting screening for PA with laboratory testing of plasma aldosterone, plasma renin activity, and a basic metabolic panel, as well as an order for an e-consult to provide guidance on interpretation of results, for eligible patients. Outcomes will be ascertained by electronic health record review at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18+
* Seen by clinician at one of the intervention practices at least once in the prior 2 years
* History of Hypertension (ICD Code) PLUS ≥1 of the below:

  * Outpatient BP \>150/100 on 2 or more occasions
  * Three or more current antihypertensive medication prescriptions
  * Potassium level \<3.5mEq/L or potassium supplement prescription in the last 5 years
  * History of Atrial Fibrillation or Atrial Flutter (ICD Code)

Exclusion Criteria:

* History of Primary Aldosteronism (ICD Code)
* Prescription for a Mineralocorticoid Receptor Antagonist (MRA) within the last 3 months
Non-comparative Trial of the Combination of HCQ and AZI in the Treatment of ICU Patients

This research is designed as an open-label,non-comparative prospective trial.

The objects of this research are as follows:

(1) To measure the duration of viral shedding in respiratory secretions of patients with moderate or severe COVID-19 infection treated with the combination of Hydroxychloroquine and azithromycin. (2) Evaluate the case fatality rate, the clinical response and length of stay in hospitalized patients with moderate and severe COVID-19 infection. (3) To report the safety of the drug combination in hospitalized patients with moderate and severe COVID-19 infection.

Eligibility Criteria:
Inclusion Criteria:

1. Adults aged \>18 years of age with lower respiratory infection with SARSCo2 documented by a positive RT-PCR in nasopharyngeal sample admitted to the University of New Mexico Hospital, with an oxygen saturation of less than 94%, on room air, or a respiratory rate \>24 per minute, or HR\>125 per minute of a PaO2/FIO2\<150.
2. Patient with life expectancy \>48 hours.
3. Pregnant women may be included if deemed necessary. There is insufficient information regarding the safety of hydroxychloroquine and azithromycin during pregnancy. Consequently, these medications are not recommended when pregnant or planning to become pregnant. However, investigators may prescribe hydroxychloroquine and azithromycin if deemed necessary.
4. Azithromycin is excreted in human milk, therefore participants should not breast-feed whilst taking Azithromycin, because it may cause side effects including diarrhoea and infection to a baby. It is recommended to discard the milk during treatment and up until 2 days after discontinuation of treatment. Additionally, hydroxychloroquine should not be taken whilst breast-feeding. However, investigators may prescribe hydroxychloroquine and azithromycin if deemed necessary. Page 6 of 23 Version Date: 04.16.2020
5. Adults unable to consent will be included with the consent of their Legally Authorized Representative (LAR). Assent will be pursued from cognitively impaired participants if they are able to provide assent. Note that this does not preclude the enrollment of cognitively impaired participants that cannot provide assent, but would allow those that can the opportunity to do so.

Exclusion Criteria:

1. Prisoners
2. Pre-/co-existing medical conditions, including any of the following:

   Known allergy to study drugs. Contraindication to treatment with study drugs, including retinopathy, and QTc prolongation defined by QTc\>450 in males and \>470 in females. Unless, it is the opinion of the treating physician(s) that the benefits to treat with medications outweigh the risks. Known chronic kidney disease, stage 4 or 5 or receiving dialysis. Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
3. Weight \<40 kg.
4. Current use of: hydrocholoroquine or cardiac medicines of: flecainade, Tambocor; amiodarone Cordarone, Pacerone; digoxin or Digox, Digitek, Lanoxin; procainamide or Procan,Procanbid, propafenone, Rythmal.
Assessment of PD-1 and PD-L1Tissue Expression Levels in Lichen Planus Patients: A Case-Control Study

Assessment of Programmed Cell Death Protein 1 (PD-1) and Programmed Cell Death Ligand 1 (PD-L1) Tissue Expression Levels in Lichen Planus Patients: A Case-Control Study

This prospective Case Control study will be conducted at Kasr Al-Aini Dermatology Outpatient Clinics and will include 30 LP patients and 30 normal healthy controls which will be recruited and assessed for eligibility for inclusion according to the above criteria.

All participants (patients \& controls) will be subjected to the following:

* Written informed consent.
* Detailed history including onset, course, duration of the disease and history of drug intake within 1 month before the eruption.
* Clinical assessment of the Severity by using LP Severity Index (LPSI) (Kaur et al., 2020).
* Skin biopsy will be taken under local anesthesia :
* From each normal control; a 3 mm punch skin biopsy from a sun protected area will be taken and preserved in PBS and kept frozen at -80 degrees Celsius for ELISA study.
* From each LP patient; two punch skin biopsies will be taken and preserved in PBS and kept frozen at -80 degrees Celsius for ELISA study:

  i. The first biopsy will be a 3 mm punch biopsy from the center of LP lesional skin of sun protected area ii. The second biopsy will be a 3 mm punch biopsy from non lesional skin at least 15 cm away from the edge of any existing LP lesion of sun protected area
* The level of PD1 and PD-L1 will be detected using ELISA technique.
* The lesional biopsy will be assessed by routine hematoxylin and eosin (H\&E) to confirm the diagnosis of LP
* Patients' serial numbers only will be used on data collection sheets and ELISA specimens' labels. Data will be entered on a computer with access limited to the researchers in order to ensure confidentiality of patients' information and lab results.

Eligibility Criteria:
Inclusion Criteria:

* Age group above 18 years old
* Patients of both genders
* Classic type of cutaneous LP.

Exclusion criteria:

* Topical treatment for LP 2 weeks before enrollment in the study or systemic treatment for LP 4 weeks before enrollment in the study and 3 years for systemic retenoids.
* Actinic LP , LP pigmentosus and Mucosal only LP
* Drug induced lichenoid eruption
* Conditions precluding taking skin biopsy : bleeding tendency , lidocaine allergy
* PD-1 associated-diseases e.g.: SLE, Cancers including melanoma and non-melanoma skin cancers, and Bullous Pemphigoid