cyrilzakka/clinical-trials huggingface dataset:
CognivAiD Real-World Evidence Clinical Registry (CONNECT Registry)

This is an observational, prospective cohort of patients who were prescribed or have taken CognivAiD as prescribed by the attending physician. The safety and efficacy of CognivAiD have been established in clinical studies. The registry will assess the safe use and effectiveness of CognivAiD in a real-world setting. The registry is designed as a product registry in clinical practice. The design also takes into account the different scenarios of product use in the real world (e.g., switching therapies during follow-up, use of multiple products in combination or sequence, different dosing, and compliance).

While the safety and efficacy of CognivAiD is established in clinical studies, this registry will assess the safe use and effectiveness of CognivAiD in the real-world setting. The design also takes into account the different scenarios of product use in the real world (e.g., switching therapies duObjectivesThe primary objective of this registry is to evaluate the use, safety, and effectiveness of CognivAiD This project is not a clinical trial wherein an active intervention intended to change human subject's outcome is implemented and takes decision-making away from the physician and patient. This registry uses an observational study design that does not specify or assign treatments or therapies. The registry is designed by keeping as closely as possible to real-world practice and as unobtrusive as possible to closely reflect usual practice and normal standards of care.

There are few inclusion and exclusion criteria to include a broad range of participants to make the results more generalizable. Participants are observed as they present for care and the data collected reflects existing tests, measurements, and treatments a healthcare provider customarily uses. Participation in the registry is entirely voluntary.

The primary objective of the registry is to evaluate the use, safety, and effectiveness of CognivAiD in a real-world setting. The primary data elements include the reporting of side effects and adverse events. Data collection and includes demographics, education, number of years, past medical history, CognivAiD information and, neurological status by the standard clinical practice and normal standard of care. Cognitive Assessment will be performed as per routine clinical visit. Collected data will be entered into the online study database.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Legal age as per country requirement
* Already taking or having to receive a prescription for CognivAiD (decision must have been made before consideration to participate in the registry)
* Agrees to be included in the registry, provides written consent inclusion criteria
* Male or female
* Legal age as per country requirement
* Already taking or having to receive a prescription for CognivAiD (decision must have been made before consideration to participate in the registry)
* Agrees to be included in the registry, provides written consent, and allows retrieval and analysis of data by local requirements.
Exparel Versus Bupivacaine in Post-operative Pain Control

This is a prospective, randomized study to evaluate anaesthetic parameters, postoperative analgesia and oral analgesic consumption comparing exparel (liposomal bupivacaine) vs. standard bupivacaine

The main purpose of this prospective, randomized study was to evaluate anaesthetic parameters, postoperative analgesia and oral analgesic consumption comparing exparel (liposomal bupivacaine) vs. standard bupivacaine. At the end of the third molar extraction surgical procedure and at least fifteen minutes following the most recent administration of 2% lidocaine with 1:100,000 epinephrine (routine for this procedure), patients will, at random, receive mandibular and maxillary infiltrations with 3mL of 1.3% liposomal bupivacaine (Exparel) or with standard 3mL standard bupivacaine. Electronic home questionnaires will be completed by the patient following the procedure for 96 hours to evaluate these clinical parameters

Eligibility Criteria:
Inclusion Criteria:

* Male and nonpregnant female adults (≥18 years of age) with American Society of Anesthesiologists physical status classification 1, 2, or 3 who were scheduled to undergo bilateral third molar extraction (extraction of all 4 third molars) under local anesthesia and general anesthesia Study participants were required to have full or partial bony impaction of both mandibular third molars.

Exclusion Criteria:

* history of allergy or contraindication to amide-type local anesthetics, epinephrine, or opioids a history of any disease or condition or recent use of any drug that, in the opinion of the investigator, might increase the risk of surgery or interfere with study evaluations any use of long-acting opioids, nonsteroidal anti-inflammatory drugs, aspirin, or acetaminophen within 3 days before screening or use of opioids within 24 hours of screening Patient that is pregnant or suspected to be pregnant Adults that cannot speak English, adults that are unable to consent on their own, or persons that are listed as vulnerable individuals will not be part of the study
The Safety and Efficacy Assessment of Cosmetic Products Containing Assam Tea Extracts in Volunteers.

Thailand has entered an aging society, prompting increased research on improving the elderly quality of life and preventing age-related diseases, with a particular focus on skin aging. Skin aging is linked to the degradation of dermal and epidermal tissue, leading to decreased collagen, elastin, and glycosaminoglycans, which causes reduced skin elasticity and wrinkles.

Assam tea is native to northern Thailand and is traditionally used in local products like fermented "Miang." Research shows that Assam tea contains high levels of polyphenols, particularly catechins, which have strong antioxidant properties that help combat conditions such as cancer, cardiovascular disease, and skin aging.

The study aims to study the effect of cosmetic products from Assam tea on irritation, moisturization, skin elasticity, wrinkles, and satisfaction in volunteers to enhance its value, particularly for the elderly. This effort is intended to boost the local economy, promote community-based tourism, and expand Assam tea products to national and international markets, ultimately improving livelihoods and addressing environmental concerns in northern Thailand.


Eligibility Criteria:
Inclusion Criteria:

* Aged 35 years and older
* Good physical and mental health
* Willing and able to provide informed consent to participate and complete the entire duration of the study

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Presence of existing dermatological conditions
* History of autoimmune disorders
* Prior use of products related to wrinkle reduction or those containing active ingredients that stimulate collagen or elastin production, including topical and oral products used within the past three months (e.g., coenzyme Q10, marine extracts, pine bark extract, glutathione, and vitamin C)
* Participation in any other volunteer study or program within the past three months
* Use of the following medications within the past three months: contraceptives, phenytoin, hydantoin, levodopa, chloroquine, cancer chemotherapy drugs, or medications containing heavy metals
* History of receiving dermatological or cosmetic procedures such as IPL (Intense Pulse Light) laser, phonophoresis, iontophoresis, laser treatments, Botox injections, fillers, or stem cell injections
* Volunteers who exhibit sensitivity or irritation to the test products used in the study
Association of Transversus Abdominis Plane Block (TAPB) with Postoperative Delirium (POD) in Elderly Patients Undergoing Major Gastrointestinal Surgery

Postoperative delirium can increase postoperative adverse reactions and prognosis in elderly patients undergoing gastrointestinal surgery. This study studied the effects of ultrasound-guided transversal plane block on postoperative delirium, opioid consumption and prognosis in elderly patients undergoing gastrointestinal surgery, comprehensively evaluated the effectiveness and safety of TAPB, and evaluated its clinical value.

Postoperative delirium (POD) is a common neurocognitive disorder in elderly patients after surgery, which is characterized by attention deficit, memory impairment and confusion, usually occurring within one week after surgery. It occurs in 11%-51% of elderly patients undergoing gastrointestinal surgery and is associated with long-term poor prognosis such as dementia and increased mortality. Risk factors include advanced age, high ASA grade, hypoalbuminemia, and prolonged anesthesia. Regional nerve block (NBs), as the core means of multimodal analgesia, has been shown to reduce the incidence of POD in orthopedic and thoracic surgery by reducing opioid use and stress response, but its effect in elderly gastrointestinal surgery still needs to be further explored. Transverse abdominal muscle plane block (TAPB) is a commonly used technique in abdominal surgery. It can effectively control pain and reduce inflammation and stress response by blocking sensory nerves in the abdominal wall. This study focused on the effect of TAPB on POD in elderly patients undergoing major gastrointestinal surgery, aiming to provide evidence-based evidence for optimizing perioperative anesthesia management.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥65 years;
2. major gastrointestinal surgery, defined as procedures lasting more than one hour and involving partial resection of the stomach or intestines;
3. general anesthesia with endotracheal intubation.

Exclusion Criteria:

1. emergency surgeries;
2. transanal endoscopic microsurgery (TEM);
3. patients with a history of preoperative delirium, altered consciousness, or psychiatric conditions, such as epilepsy, Alzheimer's disease, Parkinson's disease, schizophrenia, and anxiety or depressive disorders, as well as encephalopathies (hepatic, pulmonary, and renal) and hydrocephalus, along with those experiencing significant preoperative visual or auditory impairments;
4. patients who died within 24 h postoperatively or missing data of \>50% in their medical records.
Prognostic Model Heart Failure

This study aims to determine the prognosis of heart failure in our population by using multiple validated risk scores and to evaluate the strengths of these scores in assessing prognosis with better discrimination.

After fulfilling the eligibility criteria, informed consent will be obtained from all the patients regarding using data for research while maintaining anonymity. All the included patients will be interviewed by the assigned physician to complete the detailed questionnaire, including patient demographics, risk factors, and validated questionnaires including the Acute Decompensated Heart Failure National Registry (ADHERE), The Get With The Guideline-Heart Failure (GWTG-HF) Risk Score, the Ottawa Heart Failure Risk Scale (OHFRS), and EHMRG30-ST score. All the patients will be followed after 30 days, and survival status will be obtained. The AUC of the GWTG-HF risk score for all-cause death was 0.687 (95% CI, 0.649-0.725) \[18\], at 95% confidence interval, ±3% margin of error, the sample size was calculated to be n=626 patients. The calculated sample size was inflated by a factor of 1.5 for the design effect; hence, the sample size for the study will be N=939.

For data verification, 10% of the data will be cross-checked with the source document (Patient file).

Eligibility Criteria:
Inclusion Criteria:

* Patients of age \> 18 years or more
* Either gender
* Patients visited the emergency department at NICVD, Karachi
* Newly/Already diagnosed with Heart Failure
* Giving informed consent
* Who can be followed in 30 days via Telephone or in OPD

Exclusion Criteria:

* Patients of age \<18 years
* Patients who do not give consent
* Patients who are mentally handicapped due to any neurological or psychiatric illness (excluding depression/anxiety)
Immunologic Memory (Supp. of ATN 024)

This is an exploratory, laboratory-based evaluation of cellular immune response to immunization with hepatitis B surface antigen in HIV-infected and HIV-uninfected adolescents. This is a substudy of ATN 024 and ATN 025. This substudy will compare cellular immune response in responders and nonresponders to immunization and also evaluate the relationship of these factors to the persistence of known correlates of serologic protection for the hepatitis B virus.

This substudy will enroll volunteers from participants of ATN 024 and ATN 025. Participants in ATN 024 are HIV-infected youths aged 12-24 years while participants in ATN 025 are HIV-uninfected youths aged 12-17 years. These youths must also be negative for HBV core antibody, HBV surface antigen, and HBV surface antibody to be eligible.

Blood will be drawn from study participants prior to immunization, 1 month after completion of primary immunization and at study exit (week 72 for ATN 024 and week 76 for ATN 025) for cytokine assays and enumeration of antibody-secreting cells. In addition, the antibody to HBV surface antigen will be determined 2 and 4 weeks after supplemental immunization in nonresponders to the primary series and at study exit.

This laboratory substudy is designed to evaluate some aspects of cellular immune response to hepatitis B vaccination that are directly related to the generation and durability of antibody response to HBV surface antigen in HIV-infected and HIV-uninfected adolescents. Cytokine production by peripheral mononuclear cells will be determined following in-vitro stimulation, and antibody-secreting cells will be enumerated.

Eligibility Criteria:
Inclusion Criteria:

* Subjects that are eligible for participation in ATN 024 and ATN 025 are eligible for ATN 048. Subjects consented for ATN 024 or ATN 025 should be consented for ATN 048 at the same time. A written informed assent/consent must be obtained from the subject along with written parental/legal guardian permission as determined by the local IRB before any study-related procedures are performed.
A Prospective Observational Trial to Determine Cardiovascular Diseases in HIV-infected Patients

The HIV/HEART study (HIVH) is an ongoing, prospective, multicentre trial that was conducted to assess the incidence, the prevalence and the clinical course of cardiovascular diseases (CVD) in HIV-infected patients. The study population includes outpatients from specialized HIV-care units of the German Ruhr region, who were at least 18 years of age, were known to have a HIV-infection and exhibited a stable disease status within 4 weeks before inclusion into the trial. From March 2004 (Pilot phase) to May 2014 (7,5 year Follow-up) 1481 HIV+ patients were recruited in a consecutive manner. The standardised examinations included a targeted assessment of medical history and physical examination. Blood was drawn for comprehensive laboratory tests including HIV specific parameters (CD4 cell count, HIV-1 RNA levels) and cardiovascular items (lipid concentrations, BNP values and renal parameters). Furthermore, non-invasive tests were performed during the initial visit, including additional heart rate and blood pressure measurements, electrocardiogram (ECGs) and transthoracic echocardiography (TTE). Examinations were completed in accordance with previously defined standard operating procedures. CVD were defined as coronary, cerebrovascular, peripheral arterial disease, heart failure or cardiac vitium.

A comprehensive detailed description of the study procedures had been previously published (European Journal of medical research 2007;12:243-248).

Comprehensive non invasive cardiovascular examination

* Anamnesis
* File recherche,Physical examination
* Documentation of the cardiovascular and antiretroviral medical therapy
* Electrocardiogram
* Transthoracic echocardiography
* Exercise electrocardiogram
* Exercise Montreal Cognitive Assessment test
* Exercise the Grooved Pegboard test
* Blood collection
* Questionnaire to quality of life and health economics

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Known HIV-infection
* Written informed consent

Exclusion Criteria:

* Acute cardiovascular disease
* Unstable hemodynamic status in the three weeks before inclusion
* Pregnancy
A Study of Orally Administered Pimodivir in Adult Participants With Hepatic Impairment

The purpose is to evaluate the pharmacokinetics (PK) of a single oral dose of 600 milligram (mg) pimodivir in adult participants with impaired hepatic function compared to adult participants with normal hepatic function.


Eligibility Criteria:
Inclusion Criteria:

* Participant must have a stable hepatic function as confirmed by albumin levels, prothrombin time (PT), International Normalized Ratio (INR), and platelet count measured during screening and those measured within 24 hours prior to study drug administration. Participants with a Transjugular Intrahepatic Portosystemic Shunt procedure will be allowed to participate in the study
* Participant must have a body mass index (BMI; weight \[Kilogram {kg}/height\^2 \[meter {m}\^2\]) between 18.0 and 38.0 kg/m\^2, extremes included, and body weight not less than 50 kg at screening
* Participant must have a 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function at screening, including: (a) Sinus rhythm; (b) Pulse rate between 45 and 100 beats per minute (bpm); (c) QT interval corrected for heart rate (QTc) according to Fridericia formula (QTcF) less than or equal to (\<=) 450 millisecond (ms) for male participant and \<= 470 ms for female participant; (d) QRS interval of less than (\<) 120 ms; (e) PR interval \<= 220 ms and (f) Electrocardiogram morphology consistent with healthy cardiac conduction and function. Participant with pacemaker is eligible as long as all criteria mentioned above are met
* A woman, except if postmenopausal, must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin \[beta-hCG\]) at screening and a negative urine pregnancy test on Day -1
* Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies

Exclusion Criteria:

* Participant has known allergies, hypersensitivity, or intolerance to pimodivir or its excipients
* Participant has donated blood or blood products or had substantial loss of blood (more than 500 milliliter \[mL\]) within 3 months before administration of the study drug or intention to donate blood or blood products during the study
* Participant has received an experimental drug (including investigational vaccines) or used an experimental medical device within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before administration of the study drug is scheduled
* Participant has preplanned surgery or procedures that would interfere with the conduct of the study
* Participant is a woman who is pregnant, breast-feeding, or planning to become pregnant while enrolled in this study or a woman of childbearing potential who is unwilling to use an acceptable method of contraception
Analysis of the Mechanisms of Protective Humoral Immunity in Response to the Pneumococcal Vaccine

The lack of clear guidelines and studies addressing the proper response to the pneumococcal vaccine (Pneumovax ®) has hampered our ability to diagnosis and care for our immunodeficiency patients. Should an age matched normal response range to the Pneumovax ® be established, it would have a profound impact in the diagnosis, safety and care of immunodeficiency patients. Moreover, characterizing the B cell compartments response to the Pneumovax ® may better delineate the mechanism of protective immunity from Pneumovax ® and provide an additional tool for the diagnosis and care for immunodeficiency patients.

The ability to respond to a polysaccharide vaccine antigen is an integral part of evaluating a patient with immunodeficiency. The pneumococcal vaccine (Pneumovax ®) remains the only readily available and the most widely used unconjugated polysaccharide vaccine. Although the pneumococcal vaccine is widely used test the immune systems response to a polysaccharide antigen, no clear guidelines or studies exist to what is considered a proper response to the Pneumovax ®. Immunoglobulin M (IgM) memory B cells are thought to play an important role in protection against pneumococcal disease. It is not known to what extent the ability of B cells to be activated in response to pneumococcal vaccination contributes to protective immunity. To address these issues, the following two specific aims are proposed:

Specific Aim 1. Assess Immunoglobulin G (IgG) antibodies to pneumococcus pre- and post-pneumococcal immunization in healthy controls Specific Aim 2. Analysis of B cell subsets in blood of healthy controls pre-and post-pneumococcal immunization to identify changes in memory B cell, class switched and activated B cells.

Eligibility Criteria:
Inclusion Criteria:

* Patients from 20 to 70 years of age

Exclusion Criteria:

* Previous or current diagnosis of an immunodeficiency (primary and secondary)
* Previous or current diagnosis of a rheumatological disorders (Rheumatoid arthritis, Lupus, Sjögren, vasculitis), cancer, diabetes, active infection and/or other chronic diseases (multiple sclerosis, etc)
* Current or previous use (within that last 6 months) of systemic/inhaled corticosteroids, sulfasalazine, and other immunosuppressive agents (cyclosporin, methotrexate, CellCept) anti-convulsants (phenytoin, carbamazepine), gold, d-penicillamine, and anti-malarials (quinine, chloroquine, hydroxychloroquine)
* Pregnancy
Efficacy of Topical Cyclosporin for Ocular Rosacea

The purpose of this study is to determine whether Restasis (topical cyclosporin) is effective in the treatment of ocular rosacea

The study is designed to compare the efficacy of topical cyclosporin (Restasis) with that of Refresh Endura for the treatment of the signs and symptoms of ocular rosacea in patients presently controlled on topical corticosteroids

Eligibility Criteria:
Inclusion Criteria:

* Patient at least 18 years old, but younger than 65
* Diagnosis of acne rosacea
* Active ocular rosacea based on lid findings of meibomian gland dysfunction with lid telangiectasia and hyperemia of at least 2+
* Schirmers test of greater than 5mm in at least 1 eye
* If patient currently using lid hygiene must maintain regimen during study
* Stop oral antibiotics at least 4 weeks prior

Exclusion Criteria:

* Use of topical cyclosporin within last 90 days
* Visual acuity of 20/100 or better in both eyes
* Pregnant or lactating females
* Active ocular infection
* Scarring of central cornea
* Eyelid defects,abnormal lid positioning or lagophthalmos
* Flax seed or Fish oil supplements within last 30 days
Diagnostic Potential of PET/MRI in Cardiac Sarcoidosis

The aim of the study is to find better and more specific non-invasive methods to diagnose and stage cardiac sarcoidosis with the use of advanced imaging modalities, simultaneous 3T MRI and PET. Cardiac sarcoidosis is a disease of possibly fatal outcome in young people. The use of a combined PET/MRI system with 18F-FDG and a new inflammation-tracer (18F-GE180) can become a future game changer.

Sarcoid induced focal inflammation in myocardium should show high 18F-GE180 uptake. 18F-GE180 PET scans will give reliable data about inflammatory sarcoidosis activity in the myocardium. 18F-GE180 PET is expected to improve diagnostic accuracy compared to 18F-FDG-PET and/or contrast enhanced MRI.


Eligibility Criteria:
Inclusion Criteria:

* Heart department: Suspicion of myocardial sarcoidosis after contrast enhanced cardiac MRI
* Lung department: Clinically verified lung and/or mediastinal sarcoidosis

Exclusion Criteria:

* Known malignancies
* Treatment for sarcoidosis started
* Severe arrhythmia
* Patients with pacemakers or defibrillator
* Claustrophobia
* Known alcohol or drug abuse
* Kidney failure (eGFR \< 30)
* Weight \> 120 kg
* Diabetes Mellitus type I and II
* Patients that take immunosuppressive or immunomodulatory medication for any reason