cyrilzakka/clinical-trials huggingface dataset:
Analysis of Volatile Organic Compounds in the Breath of Lung Transplant Rejection Patients Using Infrared Spectroscopy

This study will sample and analyze volatile organic compounds (VOCs) from participants considered to be at risk for developing rejection following lung transplant by using infrared spectroscopy.

The aim of this study is to sample and analyze volatile organic compounds (VOCs) from participants considered to be at risk for developing rejection following lung transplant. By using infrared spectroscopy, the breath sample analysis will help investigators describe and identify patterns of VOCs that are over- or under-represented in patients with post-lung transplant rejection when compared to the breath profiles of those without rejection. It is hypothesized that the profile of volatile chemicals in the breath of patients in the early stages of rejection will differ significantly from those individuals without rejection.

Primary objective

• To analyze the breath-born VOCs in breath profiles of lung transplant patients with rejection in comparison to lung transplant patients without rejection using infrared spectroscopy to determine the presence of lung rejection and to develop mathematical/statistical models of infrared absorption spectrum for identification of rejection.

Secondary objective

* To determine the best method to classify health status based on VOC data of breath samples
* To validate early test results on an additional infrared spectroscopic analyzer in post-lung transplant patients

The study is an unblinded, prospective case-control study. The study cohorts will include: 1) patients with confirmed post-lung transplant rejection via biopsy, and 2) control patients who have undergone lung transplant but are free from rejection as confirmed via biopsy. Breath samples collected from participants will be analyzed to characterize and further identify differences in infrared absorption profiles from each cohort using infrared spectroscopy. The data will be used to validate a previously developed machine learning algorithm.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Patient is able to give informed consent
* Lung transplant patient who had both lungs transplanted
* Patient is at least 90 days after their lung transplant
* Patient is able to provide a breath sample

Exclusion Criteria:

* Patient is less than 18 years old
* Patient received multiple organ transplants
* Patient had an organ transplant prior to their lung transplant
* Patients who received a single lung transplant
* Patient less than 90 days or more than 1 year from their lung transplant
* If patient has smoked 4 hours or less before breath sample or consumed alcohol (including mouthwash) 8 hours or less before breath sample
Efficacy of 448kilohertz Capacitive Resistive Monopolar Radiofrequency Stimulation in Chronic Shoulder Pain

448kilohertz capacitive resistive monopolar radiofrequency is a novel technique in physiotherapy and its usefulness and clinical relevance is still to be investigated. Current studies show promising results in different musculoskeletal disorders, however further studies with proper designs and conclusive findings are necessary.

Shoulder pain is is one of the most common musculoskeletal disorders, presenting a high prevalence in primary care centers. Many factors have been proposed as the cause of pain, however it is still controversial and the same regarding the best treatment option.

Treatments throw different techniques have been investigated, showing a variety of results in terms of pain and sensitivity. However, the use of 448kilohertz capacitive resistive monopolar radiofrequency as the focus of the treatment is to be explored.

The hypothesis of the present project is that focus treatments on 448kilohertz capacitive resistive monopolar radiofrequency on the shoulder will produce better outcomes in terms of ultrasound assessment, strength, pain, sensitivity and range of movement, when compared to traditional methods used like manual therapy and/or exercise.

The stimulus will be carried out on the shoulder region (suprascapular, axillar, subscapular, long thoracic or pectoralis nerves) and the thoracic region. All interventions will be developed by the same examiner, who is a physiotherapist with 6 years of clinical experience.

The outcome measures will be electromyography and dynamometry to measure strength and muscular activity. The movements required to the patient will be shoulder flexion, abduction, adduction, and extension.

To quantify sensitivity, pain pressure thresholds will be measured throw an algometer placed on the coracoid process, on the lateral area of the shoulder (two centimeters below the acromion and on the acromioclavicular joint).

To measure the range of movement, a goniometer will be used for both glenohumeral and scapular rotations.

To measure quality of life and psychological factors several questionnaires will be asked (Pain catastrophizing scale, Pain vigilance and awareness questionnaire, Self-efficacy, SPADI, Tampa Scale-11, McGill)

Eligibility Criteria:
Inclusion Criteria:

* To suffer from shoulder pain more than three months.
* Men or women aged between 18 to 65 years;
* Unilateral pain located in the anterior and/or lateral shoulder region;
* 2 out of 3 positive clinical tests (Hawkins-Kennedy; Jobe; Neer);
* Pain with normal activity ≥ 4/10 on a visual analogue scale;
* Nontraumatic onset of shoulder pain.

Exclusion Criteria:

* History of significant shoulder trauma, such as fracture or ultrasonography-clinically suspected full thickness cuff tear, following the classification of Wiener and Seitz
* Recent shoulder dislocation in the past two years
* Systemic illnesses such as rheumatoid arthritis
* Adhesive capsulitis of the shoulder
* Shoulder pain originating from the neck or if there was a neurological impairment, osteoporosis, hemophilia and/or malignancies.
The Study for Evaluate of Satety and Dfficacy of Hemostatic Device

The goal of this clinical trial is to compare the new pneumatic compression device TRAcelet with conventional compression method in patients undergone transradial coronary angiography. The main question it aims to answer is the achievement of successful hemostasis at 3 hours.

Researchers will compare conventional compression to see if new pneumatic device can provide better hemostasis.

Although there are several devices available for radial artery hemostasis, conventional compression with a gauze pad is thought to be the easiest method. One of the devices with a pneumatic compression balloon is the TRAcelet™, and there is not much research comparing the device and conventional compression method. Therefore, the investigators aimed to compare the pneumatic compression device TRAcelet with the conventional compression method in patients who underwent transradial coronary angiography/intervention.

The primary endpoint was the achievement of successful hemostasis at 3 hours. Successful hemostasis was defined as the absence of oozing and the absence of hematoma formation after the device was released. If incomplete hemostasis was observed after 3 hours, the achievement of hemostasis after an additional hour of compression was also considered successful. Conversely, if hemostasis could not be established, it was defined as unsuccessful hemostasis. The secondary endpoints included the total banding time, local vascular complications classified according to the EASY (Early Discharge After Transradial Stenting of Coronary Arteries) scale, pain or discomfort related to the transradial approach, which was assessed by the participants using the Wong-Baker Faces Pain Rating Scale and numeric pain rating scale, and the RAO at one month.

Eligibility Criteria:
Inclusion Criteria:

* aged over 20 years
* Underwent coronary angiography under suspicion of coronary artery disease
* Agreed to participate in the trial before the coronary angiography procedure

Exclusion Criteria:

* Bleeding tendency due to congenital or acquired disorders such as severe liver disease, thrombocytopenia (platelet count below 50,000 cells/μL)
* Those who were on anticoagulants.
* Patients who could not provide voluntary consent.
Heart Evaluation of Acute Ischemic Stroke with Reperfusion Therapy

Heart Evaluation of Acute ischemic stroke with Reperfusion Therapy (HEART) is a single-center observational registry evaluating the heart of patients hospitalized for acute ischemic stroke with reperfusion therapy.

This registry aims to establish quantified risk stratification and prognostic models, as well as suggest effective diagnostic and therapeutic strategies.

There is growing evidence pointing to close interactions between acute ischemic stroke (AIS) and heart diseases. Heart diseases may lead to AIS (heart-to-brain interactions), with many cardiac conditions have been proposed as potential sources of cerebral embolism, and studies have also shown that AIS can induce cardiac injury (brain-to-heart interactions), namely Stroke-Heart Syndrome. In addition, due to the commonly shared risk factors, AIS patients had a significantly higher frequency of coexisting prior known or unknown coronary heart disease (brain-and-heart interactions). These heart problems not only add complexity to the etiological diagnosis but also account for a great proportionate mortality in AIS patients with reperfusion therapy, which is the most effective treatment method for AIS. The interconnected and coexisting properties of AIS and heart diseases requires a comprehensive scheme to evaluate, prevent, and treat patients.

Heart Evaluation of Acute ischemic stroke with Reperfusion Therapy (HEART) is a single-center observational registry evaluating the heart of patients hospitalized for acute ischemic stroke with reperfusion therapy.

This registry aims to establish quantified risk stratification and prognostic models, as well as suggest effective diagnostic and therapeutic strategies.

The clinical, laboratory and imaging information will be collected at the baseline. During an estimated 3-year follow-up, the diagnostic or monitoring procedures, treatment, functional status and new vascular events will be recorded by web-based patients' self-reports, investigators' regular telephone visits.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent by patient
2. Age ≥ 18 years
3. Acute ischemic stroke (with matching brain lesion on MR imaging)
4. Enrolment within 24 h after onset of stroke-related symptoms.

Exclusion Criteria:

1. Pregnancy and / or breast-feeding.
2. Participation in an interventional study.
3. Patients refuse to participate in the research.
Evaluation of Persistent Postsurgical Pain After Breast Surgery With a Pectoral Nerves Block (Pecs) Type II

Background and objectives The Pectoral Nerves Block (Pecs) Type II is a regional anesthesia technique that provides post-surgical pain relief for patients undergoing breast surgery. Post-procedural pain relief is known to diminish persistent pain. In this prospective follow-up, the investigators evaluated whether the Pecs II block, compared to placebo, is effective in reducing persistent post-procedural pain after breast cancer surgery in female patients.

Patients and methods 140 breast cancer stage 1-3 patients undergoing mastectomy or tumorectomy with sentinel node or axillary node dissection under general anesthesia were randomized to receive a Pecs block (levobupivacaine 0.25%) or placebo (saline 0.9%). Patients were invited between 9 and 31 months after surgery to complete a persistent postsurgical pain survey.

Breast cancer is the most common cancer in women. For breast cancer patients, surgery is the most effective therapeutic intervention. Up to two thirds of female patients undergoing breast cancer surgery develop chronic post-procedural pain. This can be best understood by the fact that chronic post-procedural pain is strongly associated with acute post-procedural pain and that even minimal breast surgery can result in significant post-procedural pain.

Regional anesthesia techniques can improve acute and chronic post-procedural pain outcomes. In the prospective double blind placebo-controlled randomized controlled trial, the investigators found that the pectoral nerves (Pecs) block type II, as described by Blanco et al., provides reliable and effective post-procedural analgesia for patients undergoing breast surgery.

In this prospective follow-up, the investigators evaluate whether the Pecs II block is effective in reducing chronic post-procedural pain in female adult patients undergoing breast cancer surgery compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* participated in the Large-scale Prospective Double-blind Randomized Controlled Trial of Pecs II Block for Breast Surgery (NCT02544282)

Exclusion Criteria:

* patient refusal
Use of Mesenchymal Stem Cells in Pre-term Patients With Bronchopulmonary Dysplasia.

Bronchopulmonary dysplasia (BPD) is a disease that affects preterm newborn patients, preventing their lungs from developing properly. Allogeneic fetal stem mesenchymal cells from umbilical cord could reduce the prevalence of BPD in this patients.

Bronchopulmonary dysplasia (BPD) is a disease that affects preterm newborn patients, preventing their lungs from developing properly, and it is a disease that is nowadays increasing due to the improvement in the survival of this patients (affecting 15-50% of them).

In the Fase I Clinical Trial, the use of allogeneic fetal stem mesenchymal cells from umbilical cord proved to be safe, with no mortality or Adverse Events reported. The Fase II Clinical Trial is based in the hypothesis that the administation of mesenchymal stem cells is not only safe but feasible and can help reducing the chance of a preterm newborn patient developing BPD.

Eligibility Criteria:
Inclusion Criteria:

* Alive newborns weighing ≤ 1250 grams and GA ≤ 28 weeks, who are on mechanical ventilation with a FiO2 ≥0.3 between days 5 and 14 of life, with no immediate extubation foreseeable.

Exclusion Criteria:

* Presence of another concomitant congenital pathology at the time of inclusion: pulmonary malformations with compromised pulmonary function, active pulmonary haemorrhage, severe pulmonary hypoplasia, renal malformations with systemic compromise, congenital heart disease, polymalformative syndromes, chromosomopathies.
* Presence of refractory haemodynamic instability of any cause at the time of inclusion.
* Presence of severe neurological damage at the time of inclusion (HIV grade III or higher).
* Patients who have required major surgery in the 72 hours prior to inclusion.
* Patients who have necrotising enterocolitis (NEC) grades ≥II at the time of inclusion, according to the Bell classification.
* Patients who are children of a mother with HIV
Relationship Between CETP Deficiency and Atherosclerosis in Patients With Hyperalphalipoproteinemia

The aim of this study is to determine whether high high density lipoprotein-cholesterol(HDL-C) level and low Cholesteryl Ester Transfer Protein(CETP) activity is atherogenic or not in subjects who received health checkups. We investigate the association between CETP activities and the severity of atherosclerosis assessed by intima-media thickness (IMT) and compare the atherogenic change between in subjects with high HDL-C level, low HDL-C level, high CETP activities and low CETP activities by examining the morbidity rate of atherogenic diseases, the rate of ischemic electrocardiography(ECG) change, Calc Score of artery from chest X-ray, Ankle Brachial Index/Pulse Wave Velocity and various serum atherogenic markers. And we also examine the correlation between normal lipid profile and concentration, activity and function of surface lipoprotein in subjects with variety of lipoprotein levels, including patients with hyper-LDL-cholesterolemia, hyper-HDL-cholesterolemia with low or no CETP activity, patients with high level of remnant cholesterol or hyperlipoproteinemia of apolipoprotein(Apo)B-48.


Eligibility Criteria:
Inclusion criteria:

Subjects who are at the age of 40 and above and undergo annual health check in Omagari area including Daisen city and Yokote city and who provide written informed consent.

Exclusion criteria:

1. Those who do not provide written informed consent.
2. Those who are not able to take tests.
3. Those who are regarded not adequate as subject of this study by their physicians.
Assessment of Individual Risk of Cardiovascular Events by Platelet FcGammaRIIa

This is a Prospective, Observational Multicenter Non-Interventional Cohort Study. The primary objective is to determine whether platelet expression of FcγRIIa is associated with risk of myocardial infarction (MI), stroke and death. Secondary objectives include: 1) Develop a score that combines clinical characteristics plus platelet expression of FcγRIIa to determine the risk of MI, stroke, and death; and 2) Determine whether platelet expression of FcγRIIa is associated with risk of major bleeding. The primary endpoint is the composite of death, MI and stroke. A secondary endpoint is the incidence of clinically significant bleeding according to the Bleeding Academic Research Consortium (BARC) scale type 2-5. Approximately 800 male and female subjects with confirmed MI \[ST-segment elevation MI (STEMI) or non-ST-segment elevation MI (NSTEMI)\] will be enrolled before hospital discharge for the index event. Approximately 10 sites in the United States will participate in this study. It is anticipated that it will take approximately 12 months to enroll approximately 800 subjects. The study and subject follow-up will continue until 1) at least 80 ischemic events (MI, stroke, and death) have occurred, and 2) the last subject enrolled has completed 18 months of follow-up.


Eligibility Criteria:
Inclusion Criteria:

1. Type 1 Myocardial Infarction (STEMI and NSTEMI)
2. Must have ≥ 2 of the following risk factors:

   1. Age ≥ 65
   2. Multi-vessel coronary artery disease (MVD) defined as ≥2 vessels or left main with a stenosis ≥50%
   3. Chronic kidney disease (CKD) defined as estimated glomerular filtration rate (GFR) ˂ 60 mL/min/1.73 m2
   4. Diabetes mellitus (DM)
   5. Prior MI
3. Must agree to participate in the study, to comply with all study procedures and follow-up contact
4. Signed the informed consent form

Exclusion Criteria:

1. Requirement for treatment with full dose anticoagulant therapy (e.g., for atrial fibrillation)
2. Participation in another trial in which the subject is known to receive or could receive anticoagulant or antiplatelet treatment as part of the trial intervention.
3. Non-cardiovascular conditions that, in the judgment of the investigator, will limit survival to less than 2 years
Multi-component Real-time Remote Rehabilitation in Sarcopenia

This study is designed as a single center, non blinded, randomized controlled, dual arm trial. We designed to allocate participants in a 1:1 ratio to compare the effects of real-time remote rehabilitation and self rehabilitation with multiple components on muscle strength, muscle mass, balance, and walking ability in patients with sarcopenia. Each participant signs an informed consent form before registering for the study. This protocol follows the 2013 Standard Protocol Project: Intervention Trial Recommendation Guidelines.

This study is designed as a single center, non blinded, randomized controlled, dual arm trial. We designed to allocate participants in a 1:1 ratio to compare the effects of real-time remote rehabilitation and self rehabilitation with multiple components on muscle strength, muscle mass, balance, and walking ability in patients with sarcopenia. Each participant signs an informed consent form before registering for the study. This protocol follows the 2013 Standard Protocol Project: Intervention Trial Recommendation Guidelines.

Eligibility Criteria:
Inclusion Criteria:

According to the diagnostic criteria for sarcopenia established by the Asian Working Group for Sarcopenia (AWGS):

1. Low muscle strength:

   Handgrip strength \< 28 kg for men, \< 18 kg for women; and/or
2. Low physical performance:

   Usual gait speed (6-Meter Gait Speed, 6MGS) ≤ 1.0 m/s; and/or
3. Low muscle mass:

Skeletal Muscle Mass Index (SMI) \< 7.0 kg/m² for men, \< 5.7 kg/m² for women.

Exclusion Criteria:

1. Unable or unwilling to undergo body composition measurement.
2. Regular exercise habits within the past 6 months (resistance training ≥ 2 times/week, moderate-intensity aerobic exercise ≥ 3 times/week).
3. History of unstable cardiovascular disease, stroke, diabetes, psychiatric disorders, or other contraindications to exercise in the past 6 months.
4. Previously diagnosed with rheumatoid arthritis.
5. History of conditions affecting motor coordination, such as poliomyelitis sequelae, epilepsy, or stroke sequelae.
6. Presence of implanted medical devices due to previous fractures, heart disease, or other conditions.
7. Diagnosis of malignant tumors.
8. Unable to independently use the WeChat mini program used in this study.
Remote Monitoring with Health-Coaching to Improve Quality of Life in Older Patients with Multiple Myeloma

This clinical trial tests the effectiveness of a home-based mindfulness physical activity program with remote monitoring combined with structured telephone-based health coaching to decrease fatigue and improve quality of life in older patients with multiple myeloma (MM). Studies have shown that MM patients have the highest symptom burden among all blood cancers, with older patients experiencing more symptoms and problems, such as fatigue and decreased quality of life, compared to younger patients. There is some data to support that physical activity may have beneficial effects on fatigue, physical function, and quality of life in older cancer patients. Studies have also shown that older patients prefer activities that are gentle, holistic, and home-based. Mindfulness-based interventions have been shown to have positive effects on sleep, depression, anxiety and cancer-related fatigue. Health coaching is a patient centered behavioral change intervention that is delivered by various healthcare professionals and involves goal-setting, self-discovery, and accountability. Health coaching interventions have been shown to increase physical activity levels and improve quality of life. A home-based mindfulness physical activity program with remote monitoring combined with structured telephone-based health coaching may decrease fatigue and improve the quality of life in older patients with MM.

PRIMARY OBJECTIVE:

I. To assess the effect-size of a novel combined home-based mindfulness physical activity program with telephonic health coaching on 1) patient-reported fatigue assessed by the Brief Fatigue Inventory (BFI) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaires and 2) Health-related quality of life assessed by the Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS Global-10) questionnaire, and 3) physical activity levels measured by steps per day.

OUTLINE:

Patients participate in remote monitored home-based physical activity sessions including flexibility practice, slow walking and breathing exercises daily on 6 out of 7 days a week and receive telephone health coaching over 5-20 minutes once a week for 12 weeks. Patients also participate in a brief telephone interview at the end of 12 weeks. Additionally, patients wear a monitor on the wrist to monitor physical activity for 7 days during enrollment and at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with MM and has received treatment with \>= 1 prior lines of treatment, and currently on maintenance treatment with a proteasome inhibitor and/or immunomodulatory agent, and/or anti-C38 antibody
* The ability to read and respond to questions in English
* Age ≥ 65 years
* Moderate or higher fatigue ( \> 4) on a scale of 0-10 based on fatigue rating to question: - Rate your average fatigue over the last week, where 0 is no fatigue and 10 is extreme fatigue
* Have wi-fi connection, as the program requires wi-fi to operate

Exclusion Criteria:

* Does not meet listed inclusion criteria