cyrilzakka/clinical-trials huggingface dataset:
Causal Associations Between Allergic Rhinitis and Asthma

This study investigates the causal relationship between allergic rhinitis and asthma using a bidirectional two-sample Mendelian randomization approach. Genetic data were derived from UK Biobank for allergic rhinitis and from Finnish biobank for asthma. This analysis aims to clarify the potential causal link between these two conditions.

This observational study utilizes a bidirectional two-sample Mendelian randomization (MR) analysis to examine the causal association between allergic rhinitis and asthma. The genetic data for allergic rhinitis were obtained from the UK Biobank, encompassing 18,934 cases and 64,595 controls, while asthma data were derived from a Finnish biobank, including 20,629 cases and 135,449 controls. The Mendelian randomization analysis was performed using inverse-variance weighting (IVW), Mendelian randomization-Egger (MR-Egger), and weighted median methods to ensure robust causal inference. Additional tests, such as Cochrane's Q test and Mendelian randomization pleiotropy residual sum and outlier (MR-PRESSO), were applied to assess heterogeneity and pleiotropy, enhancing the reliability of the findings. The results are expected to provide insights into the bidirectional causal relationship between allergic rhinitis and asthma, potentially informing future prevention and treatment strategies.

Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with allergic rhinitis or asthma.
* Availability of genetic data in the UK Biobank or Finnish biobank.

Exclusion Criteria:

* Individuals without genetic data.
* Participants with incomplete phenotype or genotype data.
The Effect of Pregabalin Given Preoperatively on the Tourniquet Induced Ischemia-reperfusion

The application of tourniquet is indispensable for a bloodless surgical area in total knee arthroplasty surgery. The release of tourniquet produces reactive oxygen species which can cause injury and then ischemia-reperfusion injury emerge. Our aim in this study is to investigate effects of pregabalin, GABA analog drug, on the tourniquet induced ischemia-reperfusion injury.

Investigators will randomize patients into two groups. 1) Pregabalin group 2) Control group.

Investigators will give orally pregabalin 150 mg to the pregabalin group patients two times (first dose 1 day before surgery., second dose 1 hour before surgery). On the other hand placebo drug will give to the control group at the same times. Investigators will perform combined spinal epidural anesthesia for surgery and inject 3 cc 0.5% hyperbaric bupivacaine to subarachnoid space. Investigators will take blood samples for measurement of ischemia-reperfusion determinants, immediately before surgery, shortly before tourniquet deflation, and 20 minutes after tourniquet deflation. Then these samples will be analysed by ELISA method.

Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status I-II
2. Undergoing a total knee arthroplasty surgery
3. Accept neuroaxial anesthesia for surgery

Exclusion Criteria:

1. Any antiepileptic drug use
2. Allergic reaction to pregabalin
3. Severe hepatic, renal or gastrointestinal disorders
4. Psychiatric disorders
5. Pregnant women or breastfeeding
6. NSAID or opioid drug use for a long time
7. Diabetic or other neuropathic pain
Ultrasound-Guided Sciatic Popliteal Nerve Block vs. Erector Spinae Plane Block in Endovascular Management of CLI

Comparison of popliteal sciatic nerve block and erector spinae plane block (ESPB) in patients undergoing endovascular management of critical lower limb ischemia (CLI).

Nerve blocks, particularly regional anesthesia techniques, have been increasingly used in the endovascular management of critical lower limb ischemia (CLI). These techniques offer numerous advantages over general and local anesthesia.

Primary Advantages of Nerve Blocks:

1. Superior Pain Control

   Nerve blocks, such as femoral and sciatic nerve blocks, provide effective pain relief by anesthetizing the nerve supply to the lower limb.

   They offer more comprehensive analgesia than local anesthesia alone, as they numb the entire area around the puncture site.
2. Enhanced Patient Comfort

   Nerve blocks allow patients to remain pain-free during and after the procedure.

   They minimize discomfort even in lengthy or complex cases.
3. Reduction in Systemic Analgesic Requirements

   By providing localized anesthesia, nerve blocks significantly reduce the need for systemic analgesics, particularly opioids.

   This is essential because CLI patients often have comorbidities that make opioid use risky.
4. Fewer Opioid-Related Side Effects

   Nerve blocks reduce the incidence of opioid-related side effects, including nausea, vomiting, respiratory depression, and sedation.
5. Improved Hemodynamic Stability

Nerve blocks preserve autonomic nervous system function, reducing fluctuations in blood pressure and heart rate compared to general anesthesia.

This is especially beneficial for CLI patients, who frequently have underlying cardiovascular disease.

Eligibility Criteria:
Inclusion Criteria:

1. Patient age will be 20-70 years.
2. Patients will be diagnosed with critical lower limb ischemia by clinical presentations and investigations.
3. ASA physical status 2-3

Exclusion Criteria:

1. Patient refusal to participate in this study.
2. Patient inability to understand the scales or to describe to the investigators.
3. Coagulation disorder.
4. Sever renal or kidney dysfunction.
5. Taking opioids before admission.
6. Morbid obesity .
Gait Parameters and Balance in Patients With Obstructive Lung Diseases

In the literature, most of the studies examining the gait characteristics and balance separately or examining the relationship between them are on patients with COPD.

No study examining gait parameters in other obstructive pulmonary patients such as bronchiectasis and asthma was found.A convincing link between gait disturbances and falls in COPD patients is still unknown and further research is needed. Therefore, the purpose of our study; gait parameters and balance in individuals with obstructive pulmonary disease. We will also examine the relationship between gait parameters and extrapulmonary clinical indicators of these individuals.

Patients with COPD call walking as one of the most problematic activities in daily life. Patients with COPD walk less in daily life than their healthy peers. Gait characteristics of extrapulmonary comorbidities that probably affect the musculoskeletal and cardiovascular system vary. The gait assessment gives an idea about the biomechanical factors associated with a reduction in walking distance in COPD patients. In patients with COPD, after the onset of shortness of breath or leg fatigue, a decrease in cadence during walking, shortened stride length, an increase in the time spent in the double support period, an increase in the peak ankle dorsi flexion moment is observed. During gait, there is an increase in balance disorders in the mediolateral direction. In addition, patients with COPD walk on a constant speed treadmill with more stride time and less step width variability. Studies have shown that patients with COPD have increased temporal walking characteristics, decreased step and stride length, and increased walking variability.

In the literature, most of the studies that examine gait characteristics and balance separately or examine the relationship between them are on patients with COPD. No study examining gait parameters in other obstructive pulmonary patients such as bronchiectasis and asthma has been found. A persuasive link between walking disorders and falls in COPD patients is still unknown and further research is needed. This study will contribute to clarifying the mechanisms of why the balance studied in patients with COPD is adversely affected.

Eligibility Criteria:
Inclusion Criteria for Obstructive Lung Diseases

1. Being diagnosed with obstructive lung disease,
2. Have not experienced acute exacerbation or infection in the last 1 week,
3. To be between 18-65 years,
4. Volunteering for research,
5. To be able to walk and cooperate.

Exclusion Criteria for Obstructive Lung Diseases:

1. Use walking aid or be chronic oxygen support
2. To have orthopedic or neuromuscular comorbidities that may affect walking patterns.
3. Having had lung cancer, sarcoidosis, tuberculosis disease or lung surgery.

Inclusion Criteria for Healthy People 1.18-65 years of age, 2. Volunteer to participate in the research, 3. To be able to walk and cooperate.

Exclusion Criteria for Healthy People

1. Having any cardiopulmonary disease,
2. To have an advanced orthopedic disease that may affect functional capacity measurement and gait patterns.
The RECORD Asia-Pacific Atrial Fibrillation Registry

The Primary objective of this registry is to assess the control of Atrial Fibrillation (AF) over one year in patients attending clinical or specialized practices.

The Secondary objectives are:

* To describe key demographics and treatment features in AF patients visiting cardiologists in various countries in Asia-Pacific.
* To establish correlation between control of AF and clinical outcomes.
* To establish correlation between treatment strategies and AF control.


Eligibility Criteria:
Inclusion Criteria:

* Patient presenting with either:

  * History of atrial fibrillation diagnosed \< 1 year by standard Electro-Cardiogram (ECG) or by ECG-Holter monitoring (treated or not or whatever rhythm at inclusion).
  * New atrial fibrillation diagnosed by standard ECG or by ECG-Holter monitoring at inclusion visit.
* Patient eligible for a pharmacological treatment of AF (by rhythm or rate control agent).

Exclusion Criteria:

* AF due to transient cause (thyrotoxicosis, alcohol intoxication, acute phase of myocardial infarction, pericarditis, myocarditis, electrocution, pulmonary embolism or other pulmonary disease, hydroelectrolytic disorder, metabolic disorder, etc.).
* Post cardiac surgery AF (≤3 months).
* Mentally disabled patients unable to understand or sign the written informed consent.
* Patients unable to comply with follow-up visits.
* Patients with pacemaker, Implantable Cardioverter Defibrillator (ICD).
* Patients scheduled for pulmonary vein ablation, AV node/His bundle ablation, or pacemaker implantation.
* Patient included in any clinical trial in the previous 3 months.
* Pregnant or breastfeeding women.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ABBV-181 (Budigalimab) in Adult Participants With Human Immunodeficiency Virus (HIV)-1

This study will be conducted in two stages and will test the safety/tolerability, pharmacokinetics (how the body handles study drug) and pharmacodynamics (effects on the immune system and the virus) of the study drug ABBV-181 in Human immunodeficiency virus (HIV)-1 infected participants undergoing Antiretroviral therapy (ART) interruption.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) between 18.0 and 35 kg/m2.
* HIV-1 infected on antiretroviral therapy (ART) for at least 12 months prior to screening and on current ART regimen for at least 8 weeks prior to screening.
* Meets HIV-specific laboratory parameters as below:

  * Plasma HIV-1 RNA below lower limit of quantification (LLOQ) at screening and at least 6 months prior to screening.
  * CD4+ T cell count \>= 500 cells/uL at screening and at least once during the 12 months prior to screening.
  * CD4+ T cell nadir of \>= 200 cells/uL during chronic infection.
* Willing to undergo ART interruption.
* Agrees to use an effective barrier method of protection (male and/or female condoms) during sexual activity for protection against HIV-1 transmission throughout the entire study.

Exclusion Criteria:

* Known resistance to at least 2 classes of ART.
* History of AIDS-defining illness.
* Active or suspected malignancy or history of malignancy (other than basal cell skin cancer or cervical carcinoma in situ) in the past 5 years.
* History of or active immunodeficiency (other than HIV).
* Active autoimmune disease or history of autoimmune disease that has required systemic treatment.
* Prior receipt of immunomodulatory or immunosuppressive (including intravenous infusion or oral steroids at any dose, but excluding steroids that are inhaled, topical or by local injection) therapy within 24 weeks prior to the first dose of study drug.
* Prior therapy/exposure to ABBV-181 or any other immune checkpoint inhibitor.
* Current hepatitis B virus or hepatitis C virus infection.
* Clinically significant medical disorders that might expose the participants to undue risk of harm, confound study outcomes, or prevent the participant from completing the study (including but not limited to significant or unstable cardiac, neurologic or pulmonary disease, chronic active infectious disease except for HIV, chronic liver disease, poorly controlled diabetes mellitus and history of Stevens Johnson Syndrome toxic epidermal necrolysis (TEN), or drug reaction with eosinophilia and systemic symptoms (DRESS)).
* Known psychiatric or substance abuse disorders that would interfere with adherence to study requirements.
* Female participants must not be pregnant, breastfeeding, or considering becoming pregnant during the study.
Correlation of Perioperative Brain Metabolites With Postoperative Delirium in Elderly Oral Craniomaxillofacial Surgery Patients

In view of the increasingly severe aging situation in China, the perioperative brain health of elderly patients has received increasing attention. Postoperative delirium (POD) is a common postoperative complication characterized by acute consciousness and cognitive dysfunction. The incidence of POD in elderly patients undergoing elective non cardiac surgery is 20%\~45%, which often indicates poor cognitive recovery and becomes a heavy burden for family and society. Although the weight of human brain only accounts for 2% of body weight, the oxygen consumption accounts for 20% of the total oxygen consumption of the whole body. On July 2, 2022, the British Journal of Anaesthesia (Chinese Academy of Sciences Division 1, Anesthesiology Division 1, IF11.719), the top international Journal in the field of anesthesiology, published the scientific research achievements of the first author of the applicant. It was found for the first time that sevoflurane, the most commonly used inhalation anesthetic in clinical practice, can cause the activation of glycolysis and the increase of lactic acid in the brain of elderly non-human primate marmosets, which suggests that general anesthetics will affect brain metabolism in the perioperative period. Therefore, we hypothesized that perioperative changes in brain metabolism might be related to the occurrence of POD in elderly patients. The purpose of this study was to study the relationship between the changes of brain metabolites and POD during perioperative period by noninvasive monitoring of the characteristics of brain tissue metabolites 24 hours before and 24 hours after the operation with hydrogen ion proton magnetic resonance spectroscopy (1-HMRS). In order to complete this purpose, this study plans to collect subjects aged 65\~90 years who are scheduled to undergo oral and maxillofacial surgery under general anesthesia. The changes of brain metabolites before and after operation were collected by 1-HMRS, and the postoperative delirium related scale was evaluated to analyze the relationship between perioperative changes of brain metabolites and POD.


Eligibility Criteria:
Inclusion Criteria:

* The ASA grade of the subject is Ⅰ - Ⅲ;
* 65-90 years old;
* Oral craniomaxillofacial surgery under combined general anesthesia

Exclusion Criteria:

* The following medical devices have been installed in the body or are to be installed or implanted in the hospital: various cardiac pacemakers; Metal implants (non titanium), ferromagnetic vascular clips in the body
* The patient is left-handed;
* Patients with claustrophobia;
* People with vision and hearing impairment, illiterate or difficult to communicate;
* The operation plan includes patients with tracheotomy or postoperative catheterization;
* Refusing to sign the clinical trial consent form.
3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer

RATIONALE: Diagnostic procedures, such as 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) PET imaging, may help find and diagnose cancer. It may also help doctors predict a patient's response to treatment and help plan the best treatment.

PURPOSE: This phase I trial is studying FLT PET imaging in patients with cancer.

OBJECTIVES:

Primary

* Evaluate the use of 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) positron emission tomography (PET) imaging to measure tumor proliferation and the DNA synthetic pathway (thymidine kinase levels) in patients with cancer.

Secondary

* Determine the efficacy of FLT PET imaging in detecting lesions and estimating response to treatment.

OUTLINE: Patients undergo up to four 3'-deoxy-3'-\[18F\] fluorothymidine positron emission tomography imaging procedures.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets one of the following criteria:

  * Histologically confirmed solid tumor or hematologic malignancy
  * Awaiting biopsy or surgery for cancer evaluation of a mass detected on exam or standard imaging

PATIENT CHARACTERISTICS:

* Able to lie still in the PET scanner
* Girth and weight must be suitable to enter the gantry
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

* Not specified
Replication of the LEAD-2 Diabetes Trial in Healthcare Claims Data

Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates through standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type 2 Diabetes mellitus \[0,0\] days
* 3 or more recorded HbA1c values \[-365, 0\] days
* At least two dispensing claims for metformin \[-180,0\] days
* 1 or more recorded HbA1c values \[-90,0\] days
* Age between 18-80 \[0,0\] days

Exclusion Criteria:

* Cancer, malignant neoplasm, or MEN2 \[-1,825,0\] days
* Use of other anti-diabetic medications \[-180,0\] days
* Cirrhosis or Hepatic decompensation \[-180,0\] days
* Viral hepatitis B or C \[-180,0\] days
* Stage 5 CKD, ESRD, dialysis or renal transplant \[-180,0\] days
* MI or HF \[-180,0\] days
* Treatment with Anti-VEGFi or Photocoagulation \[-180,0\] days
* Hypertensive crisis or uncontrolled hypertension \[-180,0\] days
* Two diagnoses of hypoglycemia \[-180,0\] days
* Alcohol/drug abuse/dependence \[-180,0\] days
* Dementia and brain damages or non-compliance \[-180,0\] days
* Pregnancy \[-180,0\] days
* Type 1 DM, DKA, or other metabolic acidosis \[-180,0\] days
* Systemic corticosteroids \[-90,0\] days
Artificial Intelligence Delivered Cardiac Magnetic Resonance - Prospective Validation

Cardiac MRI (CMR) scanning allows doctors to create detailed images of the heart. However, the need for experienced cardiac radiographers to perform each scan can make CMR's delivery difficult, and some patients in the UK wait more than half a year for a scan. These radiographers must take pictures of different part of the heart, termed "views", each of which must be precisely positioned.

The investigators believe they can revolutionise CMR, by using artificial intelligence to automatically position the views so radiographers can focus on more difficult tasks.

The investigators have used a retrospective database of pseudonymised (anonymised and linked) CMR scans at our hospital to create these artificial intelligence (AI) algorithms, and they have validated them retrospectively on previous studies. The investigators now wish to test the algorithms prospectively.

In this study, the investigators will recruit patients undergoing clinical CMR scans. In addition to the routine images acquired by expert radiographers, the investigators will require a duplicate set of images, positioned and planned by the AI algorithms.

The investigators will then compare, within each patient, the AI-planned and expert-radiographer-planned scanning in terms of both speed and image quality.


Eligibility Criteria:
Inclusion Criteria:

* Adult (aged at least 18 years)

Exclusion Criteria:

* Children (patients below age 18).
* Pregnant patients.
Comparative Study of Cardiopulmonary Exercise Test Land Versus Water

At the neck level immersion, the water pressure causes significant displacement of blood from the lower limbs to the Intrathoracic circulation, triggering adaptive physiological responses due to the increase in central blood volume and consequent cardiovascular burdens. Immersion in warm water breaks the homeostasis, stimulates regulation mechanisms and responses of organs and systems beneficial to healthy and heart failure individuals. In literature there are a growing number of studies demonstrating the efficacy of exercises performed in the water.

This study is about to compare the responses of one effort in two different environment. A group of 90 men, age between 55 to 75 years old recruited after a medical consultation, with the diagnostic of Congestive Heart Failure (CHF), under treatment at the Institute of Medicine and Rehabilitation and Institute Dante Pazzanesi, considered clinically stable (no cardiac symptoms or changes in medication for at least 30 days) and Funcional Class I, II, III according to NYHA.

Experimental Design: Patients will perform an test, first on land, and in a week time in a underwater treadmill. The data will be collected in four distinct moments: 1- anaerobic threshold (AT), 2- respiratory compensation point (RCP), 3- maximal effort (ME) and recovery (R). We will compare the following variables: test total time; perceived exertion scale (Borg); Heart rate (HR); Oxygen consumption (VO2); Carbon Dioxide production (VCO2); Oxygen pulse (VO2/FC); the ventilatory efficiency (VE/VO2) and (VE/VCO2); Respiratory quotient (VCO2/VO2); Systolic and Diastolic blood pressure; electrocardiographic changes, compatible with ischemia or arrhythmia.

Eligibility Criteria:
Inclusion Criteria: Patientes, 55 - 75 year, with Congestive Heart Failure (CHF)Functional class I - II and III according to the New York Heart Association (NYHA) and Injection Fracion 32% to 38%

Exclusion Criteria: Any peripheral artery disease, diabetes, pulmonary disease, hypertension (blood pressure \>160/90) or significant cardiovascular morbidity.