cyrilzakka/clinical-trials huggingface dataset:
Prevalence of Weight Related Complications Across Diverse Weight Classifications - A Large Study in India, Pakistan, Philippines and Vietnam

This study is investigating how common weight related health problems are in people of different weight categories in India, Pakistan, Philippines, and Vietnam. The purpose of the study is to understand the prevalence of weight related health problems in different weight groups. Participants will continue their normal care and will not get any treatment as part of this study; participants will continue receiving any treatments their doctor has prescribed. The study will last for about 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any study related activities (study-related activities are any procedure related to recording of data according to the protocol).
* Male or female aged 18 years or older at the time of signing informed consent.
* Presence of at least one Weight-related complication.

Exclusion Criteria:

* Participants less than 18 years of age at the time of signing informed consent.
* Pregnant women and individuals with recent weight loss due to illness, defined as more than 5 percent (%) weight loss in the past 6 months.
Meta-analysis - Eltrombopag

The purpose of the meta-analysis was to explore the efficacy of eltrombopag versus placebo (standard of care)

Meta-analysis of three studies: Bussell 2007 \& Bussell 2009 \& RAISE (TRA102537).

Eligibility Criteria:
Inclusion Criteria:

* Adults with ITP
* Received a pre-specified treatment
* Prospective clinical studies with at least 10 patients

Exclusion Criteria:

* Subjects with ITP due to other causes
Omega-6 to Omega-3 Fatty Acid Ratio and Higher Order Cognitive Function in 7-to 9-year-olds

The purpose of this study is to investigate the role of the ratio of omega-6 to omega-3 fatty acids on executive functions. The investigators hypothesize that participants ages 7-9 years with a ratio closer to 4:1 will do better on tests of executive function than participants with a ratio closer to the purported Western diet norm of 15:1.


Eligibility Criteria:
Inclusion Criteria:

* typically-developing

Exclusion Criteria:

* not fluent in English
Development of an Algorithm for Prediction of Onset of Hemodynamic Instability in Humans

The purpose for this study is to measure the physiology of human undergoing a Lower Body Negative Pressure usea non-invasive low-power optical technique, near-infrared diffuse optical spectroscopy measurement and compare these measurement to standard monitoring procedures delineated in the Brooke Army Medical Center.

The Brooke Army Medical Center can use near-infrared diffuse optical spectroscopy to provide functional physiologic tissue and organ information without ionizing radiation and without withdrawing any blood, in a cost-effective and rapid manner. Monitoring for the onset of circulatory shock in a wounded soldier on the battlefield is typically performed by measurement of arterial blood pressure, arterial oxygen saturation, or simple auscultation of the pulse. Shock is typically recognized by non-specific signs and subjective symptoms such as cold clammy skin, pallor, weak thready pulse, unstable vital signs, and diminished mentation.

The near-infrared diffuse optical spectroscopy can measure tissue regions deeper below the skin surface and reports on larger tissue volumes in muscle and brain. The near-infrared diffuse optical spectroscopy instrument generate harmless amounts of low-level non-ionizing near-infrared ligh can measure the tissue absorption and scattering properties at depths of 1 cm or more below the skin surface include larger tissue volumes in muscle and brain. The absorption properties of tissue provide and can determine absolute concentrations of deoxygenated hemoglobin, oxygenated hemoglobin, and water, as well as the total hemoglobin saturation.

Eligibility Criteria:
Inclusion Criteria:

* Healthy nonsmoking normotensive males or females.
* Age 18 to 55 years old, Military or civilian.
* Active duty military members who are 17 years old

Exclusion Criteria:

* Age \<18 and \>55 years, except for 17 year old active duty military members.
* History of hyperthyroidism,hypertension, cardiovascular abnormalitY, respiratory illnesses,anaphylaxis,pre-syncopal/syncopal episodes,abnormal blood clotting,
* Taking drugs to alter autonomic function
* History of alcohol or drug abuse
Evaluation of KGR Prescriptions in Suppressing COVID-19 Infection.

These studies offer valuable insights into the potential development of KGR as a novel herbal-based preventive and therapeutic strategy against COVID-19.

The ongoing coronavirus disease 2019 (COVID-19) pandemic continues to present challenges despite widespread vaccination efforts, with breakthrough infections remaining a concern. This has led to increased interest in exploring alternative preventive measures, including dietary and natural product-based interventions. Previous studies have demonstrated the potential of herbal medicines in inhibiting viral infections and as therapies for COVID-19. Additionally, research has identified various herbal medicines with inhibitory properties against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, highlighting their potential in combating the virus. Here Researchers found that novel herbal medicine formula Kang Guan Recipe (KGR) is a potent inhibitor against SARS-CoV-2 viral infection. Researchers demonstrated that KGR showed inhibitory activity against variants of concern (VOCs) of SARS-CoV-2 infection. Moreover, they also found that KGR can block the interaction of viral Spike and human angiotensin-converting enzyme 2 (ACE2). Furthermore, Researchers assessed the inhibitory effect of KGR on SARS-CoV-2 viral entry in vivo and observed that serum samples from healthy human subjects exhibited suppressive activity against various SARS-CoV-2 variants after consuming KGR. These studies offer valuable insights into the potential development of KGR as a novel herbal-based preventive and therapeutic strategy against COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* Healthy participants aged 20-60 with a body weight of over 50 kilograms.
* Individuals who have never been diagnosed with COVID-19 or have recovered from COVID-19 for more than three months.
* No consumption of any traditional Chinese medicine or food containing Chinese medicine within the preceding 36 hours before the experiment.
* Vaccinated individuals who received their vaccine more than three months ago.
* Willingness to undergo venous blood tests (approximately 10 cc of blood to be drawn three times).

Exclusion Criteria:

* History of major internal medical conditions, including diabetes, hypertension, chronic obstructive pulmonary disease (COPD), asthma, abnormal liver function (AST levels exceeding 5 times the normal value), renal dysfunction (eGFR \<60), cancer, etc.
* Brain disorders such as trauma, stroke, tumors, epilepsy, or dementia.
* Mental health disorders such as depression, anorexia nervosa, or schizophrenia.
* Pregnant or lactating women. If there is suspicion of pregnancy, a commercial urine pregnancy test will be conducted.
* Smokers, alcoholics, or betel nut addicts.
* Inability to comply with the trial procedures.
* Inability to sign the informed consent form.
* Within three months of a confirmed COVID-19 diagnosis.
* Within three months of receiving a vaccine shot.
Neurodevelopmental Rehabilitation for Toddlers With Complex Heart Defects

The purpose of this project is to investigate the feasibility of using a home-based, parent-delivered model for providing neurodevelopmental rehabilitation programmes to infants who have had surgery for a complex heart defect.

Neurodevelopmental deficits are a common morbidity among children who receive surgical treatment for complex congenital heart defects in infancy. Over 40% of children with complex heart defects will have neurodevelopmental deficits that persist throughout childhood even after a successful surgical procedure in infancy1. These deficits are typically related to basic motor perceptual motor or visual motor skills. Problems integrating what is seen (visual perceptions) with body movement (motor skills) makes it difficult for children to participate in peer play and limits their ability to succeed in school, thereby having a significant impact on the child's quality of life.

Traditional, therapist-delivered rehabilitation programmes to address these delays in neurodevelopment have not previously been attempted. It would be difficult to provide direct rehabilitation programmes to these patients given that their defects are rare and few patients are located within the same geographical area. Home-based, parent-delivered rehabilitation programmes have previously been shown to be effective at improving the motor skills of school-age children with complex heart defects5. Since a home-based parent delivered model would enable the participation of infants regardless of geographic location, the feasibility of using such a model for delivering neurodevelopmental rehabilitation should be investigated.

Eligibility Criteria:
Inclusion Criteria:

Families will be eligible to participate in this study if the child:

* Had the arterial switch operation (for transposition of the great arteries) or has had a Glenn procedure (for functional single ventricle).
* Is medically stable for normal infant activities.
* Is between 12 and 24 months of age in January 2010.

Exclusion Criteria:

Families will be excluded from study participation if:

* The child has a recognized syndrome or other disability affecting neurodevelopment.
* The child has had a medical procedure in the 3 months preceding the baseline study assessment.
* The cardiologist responsible for the child's care refuses to allow the child's participation.
* The child performs substantially above age-appropriate developmental milestones during the initial assessment (in which case an intervention is unlikely to have a detectable additional benefit).
EmploYEd Antithrombotic Therapies in Patients With Acute Coronary Syndromes HOspitalized in iTalian CCUs

This registry has the aim to assess the use of different antithrombotic therapies, including untested drug combinations, routinely used during the hospitalization phase, with their timing, route and dose of administration, in consecutive patients discharged with a diagnosis NSTEMI or STEMI in Italian Cardiac care Units (CCUs) during a four-week study period.

EYESHOT-2 is a prospective, multicenter, observational, nationwide survey of patients discharged with a diagnosis NSTEMI or STEMI admitted to Italian CCUs.

The survey will be designed to include all consecutive patients, who met the eligibility criteria, admitted in hospitals with or without cardiac catheterization laboratories and cardiac surgery facilities during a period of 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients aged 18 years or more, discharged with diagnosis of myocardial infarction (NSTEMI or STEMI) admitted to CCUs undergoing myocardial revascularization (PCI or CABG) or conservative treatment. At presentation, the diagnosis of NSTEMI will be based on the measurement of troponins and assessment of ECG changes, as suggested by European Society of Cardiology (ESC) guidelines; the diagnosis of STEMI will be characterized by an acute chest pain and persistent (\>20 min) ST-segment elevation ≥ 1mm in two or more limb leads, or contiguous pre-cordial leads or left bundle branch block.
* Written informed consent signed. Patients who cannot provide the informed consent due to very severe clinical conditions can give their consent some hours/days after admission, when more favourable clinical conditions allow them to receive the appropriate information. Patients having died before giving informed consent may also be included unless the local Institutional Review Board (IRB) does not allow this procedure. In that case, it is strongly suggested to obtain relative(s) agreement through the collect of a signed informed consent.

Exclusion Criteria:

* Patients with a diagnosis of Unstable Angina,
* Patients developing MI after PCI or CABG,
* MI following non-cardiac surgery or traumatic causes,
* Patients with chest pain without elevation of troponin,
* Patients enrolled in Randomized Controlled Trial (RCTs),
* Patients already enrolled into the study from another CCU
Phamacokinetics and Safety Profiles of DA-1229_01 5/1000mg in Healthy Subjects at Fed State

This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229_01(5/1000 mg x1 tablets) at fed state.


Eligibility Criteria:
Inclusive Criteria:

* Healthy Volunteers
* BMI between 18 and 30 kg/m2
* Body weight : Male≥50kg, Female≥45kg

Exclusion Criteria:

* Allergy or Drug hypersensitivity
* Clinically significant Medical History
Positional Device Aimed at Patients With Low Back Pain

The project aims to idealize a pelvic suspension device as an auxiliary physiotherapeutic resource for patients with reduced mobility and functional capacity, which should favor autonomous and independent performance in personal, social and work tasks of the target population. This is a controlled clinical trial study. The research sample will be composed of patients of both sexes, aged 21 to 65 years, diagnosed with low back pain, referred to UEAFTO/UEPA, through the SUS care network. The research participants will be evaluated by posture, active mobility and muscle strength of the spine, evaluation of pain intensity and functional capacity. A device will be built with the function of keeping the user in position of pelvic suspension promoting lumbar traction that will consist of a structure of pvc pipes and connections and padded material. Participants will be submitted to 10 sessions of use of the device, after which they will be reevaluated through the same procedures. The information collected will be analyzed through the Graphpad prism software. To compare measured values, the Shapiro-Wilk test will be used for normality distribution. Student's t-tests will be used for the treatment of variables with normal distribution, and Fisher's and Mann-Whitney's exact tests for variables without normal distribution. It is expected to collaborate in the social integration, labor and quality of life of people affected by low back pain, as well as to promote the development of low-cost technologies in the routine of Physiotherapy and public health in the State of Pará.


Eligibility Criteria:
Inclusion Criteria:

* patients with low back pain

Exclusion Criteria:

* patients with a history of vertebral surgery
* patients with spinal tumors
* patients with intervertebral disc infections
* patients with vertebral fractures
* patients with severe osteoporosis
* patients with ankylosing processes of the spine
* patients with heart diseases
Identification of Circulating Tumor Cells in the Peripheral Blood of Lung Cancer Patients

The primary aim of this study is to determine whether we can identify human lung cancer tumor cells in the peripheral blood of lung cancer patients.

The purpose of this study is to determine whether we can identify lung cancer cells circulating in the peripheral blood of lung cancer patients using cell surface markers found on cancer cells such as CD44 and epithelial specific antigen.

Eligibility Criteria:
Inclusion Criteria:Inclusion Criteria:Inclusion Criteria (Cases):

1. Advanced stage (IIIB with malignant effusion or IV) histologically or cytologically confirmed NSCLC
2. Patients must be newly diagnosed (untreated) or have evidence of disease progression at the time of sample collection
3. ability to sign informed consent
4. at least 18 years of age

Inclusion Criteria (Controls):

1. no known prior or active malignancy
2. ability to sign informed consent
3. at least 18 years of age Exclusion Criteria:1. history of any other cancer other than non-melanoma skin cancer within the last 5 years Exclusion Criteria:1. history of any other cancer other than non-melanoma skin cancer within the last 5 years

2. pregnant women
The Effect of Remote Ischemic Postconditioning on Postoperative Renal Dysfunction in Patients Undergoing Valvular Heart Surgery

Ischemic reperfusion injury of cardiopulmonary bypass and postoperative renal dysfunction is a common problem which influence poor outcome in subjects undergoing valvular heart surgery. The incidence of postoperative renal dysfunction was reported as high as 7\~8% in heart surgery using bypass, and is thought to be caused by ischemia/reperfusion injury. Remote ischemic postconditioning was also reported to be protective for ischemic/reperfusion injury in previous animal studies and stoke patients. Therefore, the investigators are trying to evaluate the clinical effect of remote ischemic postconditioning on postoperative renal dysfunction in subjects undergoing valvular heart surgery with bypass.


Eligibility Criteria:
Inclusion Criteria:

* patients who are undergoing valvular heart surgery
* Adult
* age 19-80

Exclusion Criteria:

* peripheral vascular disease with circulation deterioration
* Renal replacement therapy
* preconditioning medication
* Myocardiac infarction within 3 weeks
* active infective endocarditis
* high dosage steroid therapy
* mental retardation
* unlettered person
Bioequivalence Study Of PHENYTOIN Suspension Made By Pfizer, Versus EPAMIN® Made By McNeil LA LLC In Healthy Volunteers Under Fasting Conditions

To investigate the bioequivalence between two compounds (phenytoin and epamin) by a randomized, single dose study under fasting conditions in healthy volunteers.

Bioequivalence study in healthy volunteers

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years
* Body Mass Index (BMI) of 18 to 26.9 kg/m2 or ± 10% variation of the ideal weight; and a total body weight \>50 kg (110 lbs).
* An informed consent document signed and dated by the subject or a legally acceptable representative.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen.
Influence of Treatment for Patent Ductus Arteriosus on Cerebral Oxygenation in Preterm Infants

The purpose of this study is to examine the influence medical or surgical treatment for patent ductus arteriosus in preterm infants on cerebral and renal tissue oxygenation and on cardiac output.

In this observational trial the investigators want to examine whether clinical or echocardiographic parameters of patent ductus arteriosus are related to

* cerebral tissue oxygen saturation, total hemoglobin, fractional tissue oxygen extraction and HbD
* renal tissue oxygen saturation, total hemoglobin, fractional tissue oxygen extraction and HbD

as measured by near infrared spectroscopy

and to

* stroke volume
* cardiac output

as measured by electrical cardiometry.

The investigators want to examine the impact of surgical and medical treatment for patent ductus on these parameters. The investigators want to compare the change of these parameters between responders to medical treatment and nonresponders.

Eligibility Criteria:
Inclusion Criteria:

* Newborn infant below 34 weeks postmenstrual age at the time of birth
* Patent ductus arteriosus with signs of hemodynamic relevance (as judged by the attending neonatologist)
* parental informed consent

Exclusion Criteria:

* Patent ductus arteriosus as part of malformation syndrome
* Additional major cardiovascular malformations
The Effectiveness of Guided Imagery on PCL-5 Scores in Adult Women With Post-Traumatic Stress Disorder

Post-Traumatic Stress Disorder (PTSD) affects a significant portion of the population, with about 13 million Americans diagnosed in 2020. Women are twice as likely to have PTSD than men. PTSD will affect 8%, or 8 out of every 100 women, at some stage in their lives. This study will check the effects of guided imagery mindfulness on PCL-5 scores in adult women with PTSD. Participants in this study will complete a PCL-5 pre-test and post-test to check PTSD symptoms before and after 6-weeks of mindfulness sessions. Each participant will engage in 15-minute sessions of guided imagery mindfulness once a week for 6 weeks. Before and after PCL-5 scores will show the effect of guided imagery mindfulness on PTSD symptom severity.

Background: Post-Traumatic Stress Disorder (PTSD) affects a significant portion of the population, with approximately 13 million Americans diagnosed in 2020. Women are twice as likely to have PTSD than men. PTSD will affect 8%, or 8 out of every 100 women, at some stage in their lives.

Purpose: This project aims to investigate the effectiveness of guided imagery, a mindfulness technique, on PCL-5 scores in adult women with PTSD.

Theoretical Framework: The Cognitive model of PTSD was developed to explain why some people do not recover after trauma and to identify maintaining factors that can be modified in treatment. This model suggests negative appraisals, disjointed trauma memories, and unhelpful coping strategies maintain PTSD.

Methods: Participants in this qualitative study will complete pre- and post-intervention PCL--5 questionnaires, a validated 20-item structured interview designed to assess PTSD symptoms. They will also engage in 15-minute sessions of guided imagery mindfulness interventions. Post-intervention, participants will complete a second PCL-5 questionnaire to evaluate any changes in symptom severity.

Results: Analysis of PCL-5 scores will provide insight into the effect of guided imagery mindfulness interventions on PTSD symptom severity.

Conclusions: Mindfulness has the potential to serve as a viable alternative or supplemental intervention for women diagnosed with PTSD. Through exploring the potential benefits of mindfulness-based interventions in managing PTSD symptoms, this study seeks to aid in the advancement of more effective treatment options.

Eligibility Criteria:
Inclusion Criteria:

* Females
* PTSD diagnosis (ICD 10: F43.1)
* 18 to 99 years old
* Not pregnant
* No suicidal ideations
* No homicidal ideations
* No audio-visual hallucinations
* A mobile device, smart phone, laptop
* Resident at the Residential Treatment Facility

Exclusion Criteria:

* Males
* Under 18 years old
* Above 99 years old
* Pregnant women
* Active suicidal ideation
* Active homicidal ideation
* Do not have mobile device
* Active audio-visual hallucinations
Single-lumen 5Fr and Triple-lumen 6Fr PICCs Are Accurate for Hemodynamic Measurement by Transpulmonary Thermodilution.

Peripherally inserted central catheters (PICCs) are increasingly used in intensive care unit (ICU) as an alternative to centrally inserted central catheters (CICCs) for intravenous infusion. In the present study the investigators try to assess their reliability for measuring cardiac index (CI) with trans-pulmonary thermodilution (TPTD) technique.


Eligibility Criteria:
Inclusion Criteria:

* adult patients (≥18 years) admitted to the ICU
* Patients requiring hemodynamic monitoring using EV1000TM
* Patients having both PICC and CICC in place (these patients had their PICC replaced with a CICC, usually at the time of ICU admission, or vice versa, usually at the end of their ICU stay, and were enrolled immediately after the placement of the new device before the previous one was removed)

Exclusion Criteria:

* body weight \<40 kg
* severe aortic regurgitation or intra-cardiac shunt
* treatment with an intra-aortic balloon pump
* contraindication for placement of PICC, CICC or a femoral arterial catheter
* abdominal aneurism
* extracorporeal circulation
* pregnancy
* lack of informed consent