cyrilzakka/clinical-trials huggingface dataset:
Pulmonary Artery Remodelling With Bosentan

The main purpose of this study is to investigate whether bosentan (Tracleer®) affects the wall thickness of the pulmonary arteries in patients with idiopathic pulmonary arterial hypertension (iPAH) and PAH related to systemic sclerosis (PAH-SSc).

The second purpose is to investigate if bosentan affects the enlargement of small vessels in the lungs in response to natural chemicals in patients with iPAH and PAH-SSc.


Eligibility Criteria:
Inclusion Criteria : · Men or women \>18 years of age.·

* Symptomatic (modified NYHA class III) iPAH or PAH-SSc·
* PAH confirmed by right heart catheterization performed within 3 months before enrolment mPAP \> 25 mmHg, PCWP \< 15 mmHg and PVR \> 3 mmHg/l/min.
* Women of childbearing potential must have a negative pre-treatment pregnancy test and use a reliable method of contraception during study treatment and for 3 months after study treatment termination.
* Bosentan naïve patients

Exclusion Criteria : · PAH other than iPAH or PAH-SSc

* Significant vasoreactivity during right heart catheterization defined as a fall in mPAP to \< 40 mmHg with a decrease \>= 10 mmHg and with a normal cardiac index (\>= 2.5 l/min.m2)· Severe obstructive lung disease: FEV1/FVC \< 0.5
* Severe restrictive lung disease: TLC \< 0.7 of normal predicted value
* Hemoglobin \<75% of the lower limit of the normal range· Systolic blood pressure \< 85 mmHg
* Body weight \< 40 kg
* Pregnancy or breast-feeding
* Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.
* Baseline aminotransferases, i.e., aspartate aminotransferases (AST) and/or alanine aminotransferases (ALT) \> 3 times the upper limit of the normal (ULN) range.
* Treatment for iPAH or PAH-SSc within 1 month before start of study treatment, excluding warfarin and acute administration of vasodilators for vascular reactivity testing during heart catheterization.
* Treatment with epoprostenol or other prostacyclin analogs for iPAH or PAH-SSc within 1 month before start of study treatment
* Treatment with glibenclamide (glyburide), fluconazole ketoconazole or ritonavir within 1 week before start of study treatment.
* Current treatment with cyclosporine A or tacrolimus
* Hypersensitivity to bosentan or any of the excipients of its formulation.
* Patient who received an investigational drug (such as sildenafil) within 3 months before start of study treatment
* Conditions that prevent compliance with the protocol or adherence to therapy.
Standard Patient Training Versus Vik Chatbot Guided Training: a Randomized Controlled Trial for Asthma Patients

The onset of smartphone usage has provided new opportunities for managing patients outside the walls of healthcare facilities. The development of asthma-specific smartphone applications represents an excellent area for partnership between developers and medical teams for delivering therapeutic education at the required time and in a personalised way. Within this context, the overall goal of the AsthmaTrain study is to perform a first, small pilot study comparing a new French-language chat-bot guided asthma patient education programme (the 'Vik' application) with the classic, authority-approved patient education program at the University Hospitals of Montpellier, Montpellier, France.

The primary objective is to compare a population of adult patients with asthma and participating in a standard patient education programme with a similar population participating in Vik-guided education programme in terms of change in overall scores on the Asthma Quality of Life Questionnaire (AQLQ).

Secondarily, the following will also be compared between the two study arms:

* the subdomains of the AQLQ score,
* lung function, overall asthma control and exacerbation rates,
* general health status via the Euroqol 5-domain 5-level questionnaire (EQ-5D-5L),
* adherence to the program and burden of the program for the medical team,
* major categories of direct health resource consumption.

Finally, because education intervention success may depend on patient-specific characteristics, an ancillary study will compare the following baseline traits between the 50% best intervention responders in either arm:

* the big five personality traits,
* the hospital anxiety and depression,
* coping mechanisms.

Eligibility Criteria:
Inclusion Criteria:

* Minimum age: 18
* Physician-confirmed diagnosis of asthma

Exclusion Criteria:

* Protected populations according to the French Public Health Code Articles L1121-6,8
* The subject has already participated in the present study
* Subject unable to comply with trial procedures/visits
* Potential for interference from another study
* Non-beneficiary of the French single-payer national medical insurance system
* Lack of informed consent
* Patients already using the Vik Asthma application in their daily lives or having already followed a therapeutic education program
Prospective Multidisciplinary Post-COVID-19 Registry Tyrol

Longitudinal, prospective observational cohort study enrolling patients with persisting symptoms (\> 12 weeks) after COVID-19 in a multidisciplinary care model.

Post-COVID-19 syndrome comprises a set of persistent physical, cognitive and/or psychological symptoms that continue for more than 12 weeks after illness and are not attributable to alternative diagnoses. As these symptoms may manifest in all COVID-19 severity grades, even in patients with mild or moderate disease, there is an urgent need for resource allocation in the health care system and accompanied research proposals to understand disease phenotypes and clinical trajectories.

With this prospective multidisciplinary registry, the investigators aim to establish a clinical and researchbased system by providing optimized medical diagnostic and therapeutic approaches in a model region in Austria (Tyrol).

Eligibility Criteria:
Inclusion Criteria:

* Individuals with persistent post COVID symptoms ≥ 12 weeks
* post COVID functional status scale (PCFS) ≥ 2

Exclusion Criteria:

* observation time after infection \< 12 weeks
* PCFS \< 2
Safety and Immunogenicity Study of Eastern Equine Encephalitis (EEE) Vaccine

This study is designed to determine the safety and immunogenicity of Eastern Equine Encephalitis (EEE) Vaccine.

This was an open-label, vaccine study of Eastern Equine Encephalitis Vaccine, Inactivated Dried, EEE, TSI-GSD 104 in healthy, adult subjects. No concurrent control group was used. The controls used in this study to assess immunogenicity were historical PRNT80 values obtained in past studies of the EEE vaccine. Rates of adverse events (AEs) were tabulated by relationship to product administration and severity.

The primary objectives are to assess the safety of Eastern Equine Encephalitis Vaccine, Inactivated, Dried EEE, TSI GSD 104, and to assess immunogenicity of Eastern Equine Encephalitis Vaccine, Inactivated, Dried EEE, TSI GSD 104.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old.
* EEE PRNT80 ≤ 1:20.
* EEE PRNT80 ≤ 1:40 for booster series
* (females) Negative pregnancy test on the same day before vaccination.
* Not planning pregnancy for 3 months.
* At risk for exposure to virulent EEE virus (with up-to-date risk assessment).
* Up-to-date (within 1 year) physical examination/tests.
* Sign and date the approved informed consent.
* Willing to return for all follow-up visits.
* Agree to report adverse events (AE) up to 28 days after each vaccination.

Exclusion Criteria:

* Over 65 years of age (for Primary Immunization).
* Clinically significant abnormal lab results including evidence of Hepatitis C, Hepatitis B carrier state, or elevated (2X normal) liver function tests.
* History of immunodeficiency or current treatment with immunosuppressive medication.
* (females) Currently breastfeeding.
* Confirmed human immunodeficiency virus (HIV) titer.
* Any known allergies to components of the vaccine.
* A medical condition that, in the judgment of the Principal Investigator (PI), would impact subject safety (i.e.-vaccination or exposure to another Alphavirus).
* Administration of any IND product or live vaccine within 28 days of EEE.
* Any unresolved AEs resulting from a previous immunization.
"Step by Step": A Feasibility Study of the Promotion of Lunchtime Walking to Increase Physical Activity and Improve Mental Well-being in Sedentary Employees

Increasing rates of sedentary living, often complemented by obesity, among large segments of the adult population are associated with costs to individual health and well-being and thereby to society as a whole. Although some workplaces offer physical activity opportunities, those employees who tend to need it the most (i.e., the health needy) are often not attracted. In this project, the investigators propose to develop and evaluate a programme that is targeted to the sedentary health needy employees. The investigators will work with the corporate partner (a large university) to attract such employees through an extensive social marketing driven campaign. A 16-week lunchtime walking programme is proposed in which walking groups are offered followed by support and motivational strategies for longer term independent walking. The investigators will examine the effects of the programme on total amount of walking (including a follow-up assessment 4 months later) and will use innovative technology (Smartphones) to also examine the effect of lunchtime walks on well-being and work performance within and between participants.


Eligibility Criteria:
Inclusion Criteria:

* healthy, mobile, 18-65 year old employees who report they are engaging in less than 30 minutes of moderate intensity physical activity per week

Exclusion Criteria:

* employees with significant auditory or visual problems and those who have severe musculoskeletal disorders that prevent them from engaging in physical activity. Medical clearance will be requested for those who report any cardiovascular disease.
The Application of Sterile Water to the Skin of Extremely Low Birth Weight (ELBW) Infants

Extremely low birth weight infants have significant water loss through their skin immediately after birth. This significant fluid loss is because they have large amounts of fluids, have immature skin and large surface area. Loss of fluids is associated with many complications. The investigators hypothesize that application of sterile water to the skin of these infants is associated with decreased fluid requirements in the first week of life , improve skin integrity and decrease some complications of prematurity.

Extremely low birth weight (ELBW) infants have significant transepidermal water loss immediately after birth. This significant fluid loss is related to proportionally large extracellular pool of fluids, the immaturity of the skin barrier, and the relatively large surface area exposed to evaporation. Water depletion in this population is associated with development of significant electrolyte imbalance in the form of hypernatremia, hyperkalemia, hyperglycemia and hyperosmolarity. In order to compensate for these losses, clinicians have to progressively increase fluid intake. Excessive fluid intake in the first days of life is associated with worsening patent ductus artriosus (PDA), necrotizing enterocolitis (NEC), bronchopulmonary dysplasia (BPD) and mortality. Also skin integrity is important to protect against skin infection and secondary sepsis. Based on recent studies and relevant data, the risk of sepsis in ELBW is up to 40% nationwide, but only about 25% at GWUH Water application is a benign treatment that is routinely applied to the skin of premature babies and was shown to decrease skin colonization. The current practice at GWUH is to clean the bodies of premature infants using a piece of damp cloth with warm water. This is performed at birth and consequently every other days. The study group will receive more frequent and standardized applications. The investigators hypothesize that application of sterile water in ELBW infants is associated with decreased fluid requirements in the first week of life. As a secondary outcome, the investigators hypothesize that sterile water application is associated with improved skin integrity, decreased incidence of BPD with no increased incidence of skin or systemic infections.

Eligibility Criteria:
Inclusion Criteria:

1. Extremely Low Birth Weight (less than 1000 grams at birth), and
2. Less than 24 hours of life

Exclusion Criteria:

1. Major congenital anomalies
2. Malformations or other surgical emergencies requiring immediate transfer.
3. Major skin abnormalities
Enhancing Performance of Cognitive Behavioral Therapy for Insomnia With an Integrative Mobile Platform

Cognitive Behavioral Therapy for Insomnia (CBT-I) has been proven as an effective intervention for the non-pharmacological treatment of insomnia. This study hypothesizes app programs of smart phone would enhance the compliance and performance of behavioral intervention of CBT-I. During a 3-year study period, 3 app modules, including electronic sleep diary along with message reminder system, social persuasion system and Tai-Chi practice system will be tested subsequently for their efficacy.

This study comprises 3 parts which are designed as an open-label, active-control study. In each year, the participants in the experimental arm receive app-assisted CBT-I. In the first year, participants with primary insomnia are recruited and assigned to the experimental arm or the active-control arm with matched age, gender and education status. The subject number in each arm is 20. Participants in each arm receive a 6-week standard CBT-I. In the experimental arm, the participants use electronic sleep diary and message reminder to record sleep pattern. In the active-control group, the participants use traditional paper-pencil sleep diary instead. In the second year, participants with primary insomnia are recruited and assigned to the experimental arm or the active-control arm with matched age, gender and education status. The subject number in each arm is 20. Participants in each arm receive a 6-week standard CBT-I. In the experimental arm, the participants use app with function of social persuasion to encourage each other. In the active-control group, no social persuasion is given beyond the treatment sessions. In the third year, participants with comorbid depressive disorder and insomnia are recruited and assigned to the experimental arm or the active-control arm with matched age, gender and education status. The subject number in each arm is 20. Participants in each arm receive a 6-week standard CBT-I. In the experimental arm, the participants use app module that provides a multi-media assisted Tai-Chi video to practice Tai-Chi. In the active-control group, a traditional Tai-CHi teaching digital video disc is provided to help the participants practice Tai-Chi.

Eligibility Criteria:
First and second year:

Inclusion criteria:

* 20 and more years old
* meet Diagnostic and Statistical Manual-IV diagnostic criteria for primary insomnia

Exclusion criteria:

* not current smart phone users

Third year:

Inclusion criteria:

* 20 and more years old
* meet Diagnostic and Statistical Manual-IV diagnostic criteria for depressive disorders (major depressive disorder or dysthymic disorder)
* mild to moderate severity of depression (Beck Depression Inventory: 13 and more but less than 29)
* mild anxiety symptoms (Bexk Anxiety Inventory: less than 10)

Exclusion criteria:

* with high suicide risk
* not current smart phone users
A Real-world Retrospective Study of Disease Outcomes in Non-severe COVID-19 Patient

Retrospective analysis of real-world disease outcomes in non-severe COVID-19 patients with high risk factors of progression to severe disease, including death, without definitive anti-SARS-CoV-2 treatment

This is a retrospective, observational, real-world study to review outcomes of Mild to Moderate COVID-19 patients admitted to Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine (hereinafter referred to as Ruijin Hospital) from March to June 2022. These patients should be with risk factors for progression to severe disease (including death) and without definitive anti-novel coronavirus (SARS-CoV-2) treatment. The database of this study will be the hospital information system (HIS) of Ruijin Hospital.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old;
2. A record of positive SARS-CoV-2 nucleic acid test results on the day of admission or on the second day;
3. Diagnosed as mild or common novel coronavirus pneumonia on admission, or with at least one of the following COVID-19-related symptoms on admission: fever, cough, sore throat, nasal congestion or runny nose, headache, muscle pain, nausea, vomiting, diarrhea , shortness of breath or difficulty breathing, chills or chills;
4. Documented or diagnosed high risk factors for progression to severe COVID-19 (including death) with one or more of the following:

   * Age ≥ 60 years
   * Cardiovascular disease (including congenital heart disease) or high blood pressure
   * Chronic lung disease (eg chronic obstructive pulmonary disease \[COPD\], asthma \[moderate to severe\], interstitial lung disease, cystic fibrosis and pulmonary hypertension)
   * diabetes
   * Has an immunosuppressive disorder or is receiving immunosuppressive therapy (eg, long-term use of corticosteroids or other immunosuppressive drugs leading to decreased immune function)
   * Obese or overweight (BMI\>25 kg/m2)
   * Sickle cell disease
   * Active cancer
   * Chronic kidney disease
   * Current smokers
   * Neurodevelopmental disorders (eg, cerebral palsy, Down syndrome) or other conditions that cause medical complexity (eg, genetic or metabolic syndrome and severe congenital anomalies)
   * Need for relevant medical support (not related to COVID-19) (eg tracheostomy, gastrostomy or positive pressure ventilation, etc.)

Exclusion Criteria:

1. Diagnosed with severe/critical COVID-19 before or on the day of admission;
2. There is a data record of having received the following treatments before progression to severe/critical COVID-19:

   * Nematicavir/ritonavir combination package (ie Paxlovid)
   * SARS-CoV-2 monoclonal antibody (Ambavirumab/Romisevirumab)
   * Convalescent COVID-19 plasma
   * Other anti-SARS-CoV-2 drugs under investigation
Safety, Tolerability and Efficacy of MK0773 in Healthy Postmenopausal Women (0773-003)

This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamic efficacy of MK0773 in healthy postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a nonsurgical postmenopausal female
* Subject is neither grossly overweight nor underweight for her height
* Subject is in good health
* Subject is willing to avoid excess alcohol and strenuous physical activity during the study
* Subject agrees to refrain from consuming St. John's Wort, grapefruit or grapefruit juice during the study

Exclusion Criteria:

* Subject has significant drug allergies
* Subject has donated blood or taken an investigational drug in another clinical trial within the last 4 weeks
* Subject is a regular user or past abuser of any illicit drug (including alcohol)
* Subject drinks excessive amounts of caffeinated beverages
* Subject has a history of cancer
The RESET Clinical Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Back Pain

The purpose of this study is to compare standard of care treatments for back pain to electrical stimulation. Stimulation is delivering small amounts of electricity to the nerves in your low back. This study will use a device called the SPRINT Peripheral Nerve Stimulation (PNS) System. The device is cleared by the FDA for up to 60 days of use for the relief of chronic or acute pain (including back pain)


Eligibility Criteria:
Key Inclusion Criteria:

* Chronic low back pain

Key Exclusion Criteria:

* Body Mass Index (BMI) \> 40
* Prior lumbar surgery
* Implanted electronic device
* Pregnant
Investigation of the Effect of Geriatric Massage

There is no study has been found to examine the effect of geriatric massage applied to the elderly with type 2 diabetes on diabetes symptoms and blood parameters. This study was planned as a pretest-posttest randomized controlled single-center study to examine the effect of geriatric massage on diabetes symptoms and blood parameters in the elderly with type 2 diabetes. 60 elderly people who type 2 diabetes who applied to the Internal Medicine Polyclinic of Bayburt State Hospital in the city center of Bayburt will the diagnosis of Type 2 diabetes will form the sample of the study. The sample will consist of two groups, the geriatric massage group and the control group. Data will be collected with the "Elderly Information Form", "Standardized Mini-Mental Test", "Diabetes Symptoms Checklist Scale", "Blood Parameters Monitoring Form". "Geriatric Massage" will be applied as an intervention. The geriatric massage group will receive 20 minutes (10 minutes on each foot) foot massage and 10 minutes back massage, two days a week for eight weeks. The control group will receive the institution's standard of care. Frequency, number, mean, Student's t test and/or Mann-Whitney U test, ANOVA and/or Kruskal-Wallis test, Chi-square test and/or Correlation and Regression Analysis will be used in the analysis of the data. As a result of this study, it is anticipated that the effects of geriatric massage on diabetes symptoms and blood parameters in the elderly with Type 2 diabetes will be determined and these effects will be included in evidence-based guidelines.


Eligibility Criteria:
Inclusion Criteria:

* Age 65-84
* No visual or hearing impairment
* Ability to communicate verbally
* Applying to Bayburt State Hospital Internal Medicine Polyclinic
* Having a diagnosis of Type 2 diabetes for at least six months
* A score of 25 and above on the Standardized Mini Mental Test
* Agreeing to participate in the research

Exclusion Criteria:

* Having vascular disease (thrombus, phlebitis, arterial embolism, severe venous ulceration)
* Having heart failure, pacemaker and neurological disease
* Body temperature being higher than 37.5°C for more than two days, suspected or diagnosed with inflammation
* Having acute pain
* Cancer and undiagnosed malignancies, receiving chemotherapy and radiotherapy
* Presence of any scar tissue, chronic inflammatory skin diseases on the back
* Having foot amputation, fracture, infection, wound, skin disease, pathology and neuropathy related to muscles and bones
Improvement of Cardiac Function in Patients With Ischemic Cardiomyopathy by Extracorporeal Shock Wave Therapy: a Multicenter Clinical Study

Cardiac shock wave therapy (CSWT) is a noninvasive new therapeutic option in the treatment of chronic refractory angina pectoris. Many domestic and international researches have revealed that CSWT contributes to revascularization by stimulating angiogenesis. We were aimed to evaluate the safety and efficiency of CSWT in the treatment of refractory angina.


Eligibility Criteria:
Inclusion Criteria:

* Patients were 18 to 80 years old;
* Coronary angiography (CA) or multi-slice CT coronary angiography (CTCA) suggestive of moderate to severe coronary artery stenosis;
* Chest tightness, onset of shortness of breath, and poor exercise tolerance after receiving formal drug treatment (with or without stent or bypass graft);
* Hospitalized more than 2 times within 1 year due to the aforementioned problems;
* CCS angina grading higher than grade II, and New York Heart Association (NYHA) class I-III;
* More than 1 month after acute myocardial infarction (AMI) and 1 month after percutaneous coronary intervention (PCI) surgery.

Exclusion Criteria:

* AMI、PCI or coronary artery bypass graft (CABG) within the 4 weeks prior to the study;
* History of heart transplantation;
* History of metal valve replacement surgery;
* Intra-cardiac thrombus;
* Left Ventricular Ejection Fraction (LVEF) \< 30 % and unstable hemodynamics;
* Arrhythmia with a rate \< 40 bpm or \> 120 bpm;
* Skin ulceration or infection in the treatment area;
* Severe obstructive lung disease.