cyrilzakka/clinical-trials huggingface dataset:
Spire Medical Health Tag Actigraphy and Sleep Validation in Adults

The purpose of this study is to collect data to validate the step- (actigraphy) and sleep-tracking performance of the Medical Health Tag device developed by Spire Health.

The purpose of this study is to collect data to validate the step- (actigraphy) and sleep-tracking performance of the Medical Health Tag device developed by Spire Health. The step data will be evaluated in a controlled environment over a range of approximately 1.0-2.5 miles per hour (i.e., slow to moderate walking) via Reference manual counting and pedometer. The sleep data will be evaluated in a natural environment (i.e., the participant's daily life and home) over one afternoon and night with Reference sleep/wake data.

Eligibility Criteria:
Inclusion Criteria:

Subject must have the ability to understand and provide written informed consent Subject is over 18 years of age Subject must be willing and able to comply with study procedures and duration Subject is a non-smoker Male or female of any race

Exclusion Criteria:

* Subject is considered as being morbidly obese (defined as BMI \>39.5)
* Any medical condition that may prevent successful completion of the tasks in a healthy manner.

  * those requiring a wheelchair or who are housebound (haven't left their home without assistance in the last week)
  * Sleep disorder
  * Gait issue
* Subjects with known respiratory conditions such as severe asthma, flu, bronchitis, or shortness of breath.
* Subjects with self-reported heart or cardiovascular conditions such as congestive heart failure (CHF) or history of stroke or heart attack.
* Any neurological condition such as Parkinson's, Alzheimer's, and Epilepsy
* Subjects experiencing significant sleep impairment or sleep disturbances
* Those with insufficient English language skills to either fully evaluate their understanding of these exclusion criteria during screening or that would otherwise impair their ability to fully participate
* Pregnant at the time of the study
* Unwilling to commit, in writing, to:

  * be on-time for the study
  * be on-time returning the devices the following day
  * avoid alcohol or intoxicants before and during the study
Relationship Between High-Density Lipoprotein Subtypes and Coronary Heart Disease Prognosis.

Cardiovascular disease (CVD) is the leading cause of human mortality worldwide, imposing substantial societal and economic burdens. Traditionally, high-density lipoprotein (HDL) has been branded as the "beneficial" lipoprotein. The Framingham study found that for every 1mg/dl increase in HDL, the risk of coronary heart disease (CHD) was reduced by 2% in men and 3% in women. Subsequent studies further affirmed the inverse correlation between HDL and the risk of CHD. However, these findings were first challenged by Mendelian randomization studies which failed to identify a causal relationship between HDL and CHD. Moreover, randomized controlled trials demonstrated that therapeutically increasing plasma HDL concentrations did not reduce the risk of CHD events, prompting doubts about HDL's status as "good cholesterol." The relationship between HDL and CHD might be more intricate than previously believed, possibly not just mediated by the quantity of HDL but also intimately linked with its function.

Several cross-sectional studies have confirmed the relationship between HDL subtypes and the severity of disease in CHD patients, yet findings are inconsistent. Conventional testing methods lack a universally accepted standard for defining or describing HDL subfractions, with issues like expensive equipment, poor repeatability, cumbersome operation, slow analysis, and low throughput. Microfluidic electrophoresis technology combines the merits of electrophoresis with microfluidic chip technology. This method facilitates efficient separation of substances in microchannels on a substrate, providing rapid and consistent results. Utilizing the latest microfluidic chip technology for HDL subfraction detection offers quick, accurate, and straightforward analysis with minimal sample volume and automation. It precisely reflects the serum concentrations of HDL subfractions HDL2b and HDL3, addressing the current pitfalls of clinical HDL subfraction analysis methods. This approach is poised to become the standard method for HDL subfraction testing.

In conclusion, existing studies on the association between HDL subtypes and CHD remain inconsistent, with most having a small sample size. Our study, leveraging microfluidic chip technology for HDL subfraction detection, aims to further investigate: the prognostic value of HDL subtypes for the long-term outcomes of CHD patients, building a risk prediction model for adverse cardiovascular events that includes HDL subtypes.


Eligibility Criteria:
Inclusion Criteria:

1. The age of the patients is over 18 years old;
2. Coronary artery disease was confirmed by coronary angiography.

Exclusion Criteria:

1. Severe valvular disease, severe myocarditis, severe hepatic and renal insufficiency, thyroid insufficiency, severe infectious or systemic inflammatory diseases, severe blood diseases, malignant tumors.
2. Lack of data on HDL subtypes.
Effects of Manual Diaphragmatic Technique Versus Lateral Coastal Breathing Exercises Among COPD Patients.

Chronic obstructive pulmonary disease is a common, preventable as well treatable disorder, which is also one of the main reasons of high mortality and morbidity characterized by irreversible airflow limitation and has respiratory system involved. The aim of this study is to evaluate the comparative effects of manual diaphragmatic technique and lateral coastal breathing on COPD patients, that these exercises will have beneficial effects or not on COPD patients. Manual diaphragmatic technique and lateral coastal breathing will increase the functional capacity and relieve the symptoms dyspnea, enhance the chest wall expansion.

This study will be a randomized clinical trial to determine the effects of both techniques on COPD patients and disease severity in patients who falls into the inclusion criteria, who are willing to participate, patients with age limit between 45 to 65 years, GOLD stage II, and patients will be excluded who have cardiac disease, abdominal or thoracic surgeries and in critical condition by taking sample of patients through non probability convenient sampling and randomly allocating them to two groups A and B out of which A will receive manual diaphragmatic techniques, B will receive lateral coastal breathing exercise up to the duration of 2 times a day, 3 days per week for up to 3 weeks. Pre and post exercise outcomes will be assessed. The data will be analyzed through SPSS 26

Eligibility Criteria:
Inclusion Criteria:

Age 45-65 years(12). Both gender female and male. Patients willing to be the part of the research. Patients with moderate level of COPD Patients with GOLD II stage(13). Patients who response to bronchodilators Patients with history of smoking(14).

Exclusion criteria:

Patients having other cardiac diseases. Patients having thoracic or abdominal surgeries. Exacerbation of symptoms before or during study. Inability of Patient to understand instructions due to mental disorder Lack of medical record Coronary artery disease (coronary angiography with stenting or bypass) Malignant tumor Patients with gastrointestinal abnormalities Patients who are in critical condition
Performance and Safety of Restylane Lidocaine for Treatment of Depressed Facial Acne Scars

The purpose of this study is to evaluate performance and safety of Restylane Lidocaine for treatment of depressed facial acne scars


Eligibility Criteria:
Inclusion Criteria:

* Intent to undergo treatment of depressed acne scars
* Presence of 5-20 scars with a diameter of up to approximately 4 mm within the treatment area
* Similar type, size and number of scars on both cheeks
* Men or non-pregnant, non-breast feeding women
* Fitzpatrick skin type I-IV
* Signed and dated informed consent to participate in the study

Exclusion Criteria:

* Presence of more than 3 scars per cheek (within the treatment area) of the following types: icepick scars or atrophic acne scars with a diameter of \> 4 mm.
* Active acne with inflammatory component
* Use of per oral or topical (facial) substances containing retinoids, bensoyl peroxide, alpha-hydroxy acid at concentrations above 10%, beta-hydroxy acid at a concentration above 2%, or antibiotic treatment for active acne within 4 months before treatment
* Use of isotretinoin within 6 months before treatment
* Post-surgical scars in the treatment area
* Previous tissue augmenting therapy or contouring with permanent filler or fat-injection in the treatment area
* Previous tissue augmenting therapy, contouring or revitalisation treatment with Calcium Hydroxyapatite (CaHa), or Poly L-Lactic Acid (PLLA), in the treatment area within 24 months before treatment
* Previous tissue augmenting therapy, contouring or revitalisation treatment with non-permanent filler such as hyaluronic acid (HA) or collagen in the treatment area within 12 months before treatment
* Previous tissue revitalisation treatment with neurotoxin, laser or light, mesotherapy, chemical peeling or dermabrasion in the treatment area within 6 months before treatment
* Previous surgery including aesthetic facial surgical therapy, liposuction, or tattoo in the treatment area
* Any medical condition that, in the opinion of the treating Investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study)
Efficacy of Brief Mindfulness Based Self- Compassion Intervention for Management of Anger Among Adolescents

This study investigates the effectiveness of a short self-compassion mental intervention in reducing aggression among adolescents. Although they display potential, current solutions are arduous and time-consuming. The study provides preliminary results on the effectiveness of this method in addressing the lack of information. The intervention's simplicity and precision have the potential to greatly influence the treatment of teenage violence. This could lead to the general acceptance and implementation of mindfulness-based self-compassion, making it accessible at a reasonable cost. The study's brevity and specificity hold promise for broader implementation. A significant gap exists in the literature concerning brief mindfulness-based self-compassion interventions tailored specifically to address adolescent aggression. Most existing studies have explored more extended interventions or general mindfulness programs, leaving a dearth of research on the effectiveness of concise, targeted interventions for adolescents dealing with aggression.

The study's focus on a brief mindfulness-based self-compassion intervention stands out as a resource-efficient and practical approach to addressing aggression in adolescents. This concise intervention's potential effectiveness offers the promise of a more accessible and cost-effective approach to addressing adolescent aggression, which is critical in our resource-constrained world. The study determined that the brief intervention is efficacious, enabling its adaptation and implementation in educational institutions, juvenile justice programs, and community organizations that work with belligerent adolescents. Due to its versatility, the conclusions of the study can be directly applied to real-world issues. The salient feature of this method is in its explicit targeting of adolescent aggression. By prioritizing self-compassion and mindfulness, this program aids in the regulation of emotions and reduces aggression among young individuals. Effective interventions have the potential to improve the psychological well-being, emotional control, and interpersonal connections of adolescents who display aggressive behavior. This study has the potential to make mindfulness-based self-compassion practices more easily available to a greater number of adolescents. This might lead to the development of practical and cost-effective solutions that promote emotional well-being and decrease aggressiveness. These strategies would have long-lasting advantages.

Eligibility Criteria:
Inclusion Criteria:

1. Students' age range of 13 to 19 years
2. symptoms of aggression.

Exclusion Criteria:

Students who are not willing to participate
Quality of Life Assessment Between Internal Endoscopic Versus Percutaneous Drainage in Biliary Obstruction

The aim of this study is to compare the quality of life in subjects with benign and malignant biliary obstruction who have or will undergo endoscopic retrograde cholangiopancreatography (ERCP) and/or percutaneous trans-hepatic biliary drainage (PTBD).


Eligibility Criteria:
Inclusion Criteria:

* Patients with benign biliary obstruction
* Patients with malignant biliary obstruction
* Patients undergoing ERCP and/or PTBD

Exclusion Criteria:

* Patients with gallstone disease
* Patients who will undergo ERCP who have previously underwent a PTBD
* Patients who will undergo PTBD who have previously underwent an ERCP
* Female patients who are pregnant
* Prisoners and other vulnerable populations
Treatment With Probiotics (Saccharomyces Boulardii) and Its Role in Bacterial Translocation and Immune Reconstitution in VIH Infection.

Objectives: MAIN: To evaluate the parameters of microbial translocation after treatment with probiotics (Saccharomyces boulardii) in HIV+ patients and its role on immune reconstitution and the changes in gut microbiota composition.

SECONDARY OBJECTIVES: 1) To analyze the progress of immune activity markers after the administration of probiotics. 2) To determine the improvement of CD4+ lymphocytes and HIV viral load in patients after taking probiotics.

Methods: Design: A prospective randomized open controlled double-blinded trial, to be performed at a tertiary care hospital in Barcelona. Subjects: Chronic HIV infected patients. Sample size: 44 cases. They´ll be divided in 2 groups: (1) Patients with CD4 +\> 400 cells / ml and undetectable viral load for more than two years (22 cases) and (2) Patients with immunodiscordancy, defined as patients with CD4 + T cells lower than 350 cells / ml despite 4-7 years of effective antiretroviral therapy. (22 cases). Intervention: Patients were randomized in 2 subgroups: (A) they´ll receive daily oral supplementation with S. boulardii for 3 months and (B) they ´ll receive placebo. Variables: bacterial lipopolisaccharide levels measured by the Lipid-Binding protein (LBP), parameters of immune activation in plasma (soluble CD14, IFN-Υ, TNF-Alpha, IL (interleukine)-2, IL-5, IL-6, IL-12)and gut microbiota composition prior to the use of probiotics (baseline), at 3 and 6 months. Immunological and clinical data. Outcome measures: quantification of bacterial translocation levels, markers of activity and immune recovery. Analysis: Comparison of variables before and after the intervention. The analysis will be performed by biological and immunological effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic HIV infection and viral load undetectable \> two years with stable ART CD4\> 400 cells / ml.
* Patients with chronic HIV infection and viral load undetectable\> two years with stable ART CD4 \<350 cells / ml.
* Inform consent signed.
* Aged between 18- No limit.

Exclusion Criteria:

* Patients who receive or have received in the past 6 months food supplements containing probiotics.
* Patients who have received antibiotic treatment in the last two months
* Patients who are poor presupposes adherence to dietary supplements.
* Patients who have changed the TAR in the last three months.
to evaluate188Re-BMEDA-liposome in Patient With Primary Solid Tumor in Advanced or Metastatic Stage

This is a study to determine the maximum tolerance dose (MTD) and to evaluate the safety of 188Re-BMEDA-liposome in patient with primary solid tumor in advanced or metastatic stage.

Rhenium-188 is an ideal radionuclide for therapeutic use due to its maximum beta emission of 2.12MeV, short physical half-life of 16.9 hours, and its 155-keV gamma emission for imaging purposes. 188Re-BMEDA-liposome consists of 2 separate components (Rhenium-188 and liposome) and BMEDA as a linker. This study aims to find the MTD, evaluate the safety, efficacy profiles and investigate the biodistribution, radioactivity and radiation dosimetry of 188Re-BMEDA-liposome on primary solid tumor in metastatic stage patient by a single intravenous injection course.

Eligibility Criteria:
Inclusion Criteria:

* Patient with histologically confirmed diagnosis of primary solid tumor, and with pathologically or radiologically documented metastases
* Disease that is measurable or evaluable by RECIST 1.1 criteria (for Solid Tumors)
* Patient with metastatic cancer that are refractory to current standard/available therapies

Exclusion Criteria:

* brain metastases
* serious concurrent infection or nonmalignant illness that is uncontrolled
* uncontrolled intercurrent illness
* Immunocompromised
* significant traumatic injury within 3 weeks before Day 0
* History of hypersensitivity to any component of study drug
Median Nerve Function During Phalen's Test

This study will use electromyography and nerve conduction studies to evaluate median nerve function during the Phalen's wrist flexion test in different wrist positions.

The Phalen's test is commonly used to assess carpal tunnel syndrome. However, it is unclear which wrist position during this test best isolates median nerve function. This study will measure thenar muscle activation and median nerve conduction in 30 healthy participants performing the Phalen's test. Different wrist flexion angles will be evaluated to determine which position optimally targets the median nerve. Results may enhance utilization of the Phalen's test in clinical practice and research.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 18-45 years
* No history of hand/wrist disorders

Exclusion Criteria:

* Contraindications to EMG or NCV
* Neurological or muscular disorders
Evaluation of a Ascensia ONYX NEXT Investigational Blood Glucose Monitoring System

The purpose of this study was to determine if untrained subjects with diabetes and without diabetes could operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18 years of age and older
* Able to speak, read, and understand English
* Willing to complete all study procedures

Exclusion Criteria:

* Hemophilia or any other bleeding disorder
* Pregnancy
* Physical, visual or neurological impairments that would make the person unable to perform testing with the BGM
* Previously participated in a blood glucose monitoring study using the ONYX NEXT or ONYX PLUS BGMS
* Working for a medical laboratory, hospital, or other clinical setting that involves training on or clinical use of blood glucose monitors
* Working for a competitive medical device company, or having an immediate family member who works for such a company
* A condition which, in the opinion of the investigator or designee, would put the person or study conduct at risk

General enrollment guidelines:

* At least 70% of subjects will be younger than age 65
* At least 10% (approximately 10-15%) of subjects will be naive users
* At least 20% of subjects with diabetes will have type 1 diabetes
A Phase 1/2, Randomized, Placebo-controlled, Observer-blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Adults 18 To 49 Years Of Age

This is the Phase 1/2 first-in-human, randomized, placebo-controlled, observer-blinded study evaluating the investigational multivalent group B streptococcus vaccine. Healthy adults aged 18 to 49 years of age with no history of group B streptococcal vaccination will be randomized to receive either a single intramuscular dose of multivalent group B streptococcus vaccine (various formulations at 3 dose levels) or a placebo (saline control).


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults (male and female) 18 to 49 years of age at enrollment who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
2. Negative urine pregnancy test at Visit 1 for all female subjects who are of childbearing potential.

Exclusion Criteria:

1. Male subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for at least 3 months after the last dose of investigational product.
2. Acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. Chronic medical conditions include human immunodeficiency virus, chronic hepatitis B virus (HBV) infection (HBV surface antigen positive), and/or hepatitis C virus infection.
3. History of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis) to any vaccine.
4. History of microbiologically proven invasive disease caused by group B streptococcus (Streptococcus agalactiae).
5. Previous vaccination with any licensed or investigational group B streptococcus vaccine, or planned receipt during the subject's participation in the study (through the last blood draw).
Desflurane and Sevoflurane in Pediatrics With Elevated Liver Enzymes

It is designed to compare effects of inhaled anaesthetic desflurane and sevoflurane on liver functions in pediatric cancer patients

Patients will be randomly allocated into two groups using a sealed envelope technique: desflurane group (Des group, n = 30) and sevoflurane group (sevo group, n = 30).

Anesthesia monitoring included electrocardiogram, continuous arterial and pulse oximetry, capnography, urine output, nerve stimulator, and esophageal core temperature.

Anesthesia will be induced with Propofol 2 mg/kg ,FentanyL 2 μg/kg and atracurium (0.5 mg/kg) was administered to achieve muscle relaxation before endotracheal intubation. End-tidal desflurane or sevoflurane concentrations during the induction were limited to 2 minimal alveolar concentration (MAC). Concentrations of inhalational anesthetics were measured using an anesthetic gas analyser (Datex-Ohmeda, Helsinki, Finland). For the maintenance of anesthesia, the inspired desflurane or sevoflurane concentration was carefully titrated to maintain the end-tidal concentration of 1 MAC. A constant fresh gas flow of 3 l/min (medical-grade air in oxygen to make inspiratory oxygen fraction 0.5) was used during the maintenance of anesthesia. Ventilation was controlled with a tidal volume of 7-10 ml/kg and ventilatory rate was adjusted to maintain an end tidal carbon dioxide ( CO2 )of 35-40 mmHg. to maintain intraoperative blood pressure (BP) and heart rate (HR) within 20% of preoperative values. additional Atracurium will be administered as appropriate. Nerve stimulator was used to monitor neuromuscular blockade on the right adductor pollicis. Hypotension (a drop in systolic BP to the extent of 30% or more or the systolic BP being less than the preoperative values) was treated with volume replacement and, when necessary, with intravenous ephedrine in incremental doses .Bradycardia (HR \< 50 beats per min) was treated with atropine if needed.

Aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT) expressed in international normalized ratio (INR), albumin, platelet count (PLT), and hemoglobin (Hb) were analysed at preoperative period, immediately after operation, and on the 1st, 2nd, 3rd, 5th and 7th, postoperative days (PODs).

Eligibility Criteria:
Inclusion Criteria:

* Age \>1 year and \< 12 years old.
* Estimated time of surgeries within 1-3 hours.
* Elevated liver enzymes less than triple folds.

Exclusion Criteria:

* Patient refusal.
* Hepatitis positive patients.
* Raising liver enzymes.
* Hepatic surgeries.