cyrilzakka/clinical-trials huggingface dataset:
A Study of Guselkumab and Risankizumab in Healthy Participants and Participants With Psoriatic Arthritis

The purpose of this study is to assess the tissue distribution of guselkumab and risankizumab in healthy participants (Part 1) and psoriatic arthritis (PsA) participants (Part 2 and Part 3).


Eligibility Criteria:
Inclusion Criteria:

Part 1:

* Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. Any abnormalities, must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator
* Has a negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease 2019 \[COVID-19\]) reverse transcription polymerase chain reaction (RT-PCR) test within 72 hours prior to study intervention administration
* Body weight within 50 kilograms (kg) to 100 kg and body mass index (BMI) within the range 18 kilograms per meter square (kg/m\^2) to 30 kg/m\^2 (inclusive)

Parts 2 and 3:

* Have a diagnosis of psoriatic arthritis (PsA) for at least 3 months before the first administration of study agent and meet classification criteria for psoriatic arthritis (CASPAR) at screening
* Have active plaque psoriasis

Exclusion Criteria:

Part 1:

* History or current signs and symptoms of liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, genitourinary, or metabolic disturbances
* Had major illness or surgery (example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from illness or surgery, or has surgery planned during the time the participant is expected to participate in the study or within 21 weeks after the last dose of study intervention administration

Parts 2 and 3:

* History or current signs and symptoms of severe, progressive, or uncontrolled liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (with the exception of PsA), psychiatric, genitourinary, or metabolic disturbances
* A nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular)
Determinants of Obtaining Covid Vaccination Among Health Care Workers

Despite the global preventive efforts (physical distancing, face, mask, travel constraints, and quarantine) to contain the infection, COVID-19 is continuing with its devastating consequences on health, life, and economics. The world's hopes are attached to a successful preventive measure that is the vaccination which has proved its capability to stop infections and save lives over the years. World Health Organization (WHO) declared vaccination hesitancy as one of the top 10 obstacles for global health. Multicentric study involved Arab countries measure hesitancy of HCWs toward vaccine, it reported the highest rates of hesitancy were among participants from the western regions of the Arab world (Egypt, Morocco, Tunisia, and Algeria). This study aims to evaluate the attitude and the determinants of this attitude of HCWs towards receiving or refusing to have their first dose of vaccination.


Eligibility Criteria:
Inclusion Criteria:

* All staff how are working in AUH and offered to receive the first dose of AstraZeneca \& Sino pharm vaccine.

Exclusion Criteria:

* Those who are not eligible to receive the vaccine
* Those who are not freely offered to receive the vaccine
Behavioral Treatment for Substance Abuse

This pilot project will evaluate a new mind-body intervention called Mind-Body Bridging (MBB) for reducing substance abuse problems in women who are undergoing a substance abuse treatment program. The main hypothesis is that MBB will be more effective than the control (standard) intervention program in helping people reduce their craving for illicit substances and/or alcohol.

This is a randomized clinical pilot study in which MBB will be compared with a standard treatment program for substance abuse. Both groups will run concurrently over the course of a 10-week period, twice per week.

Eligibility Criteria:
Inclusion Criteria:

* Substance abuse or dependence
* Resident/day client in the House of Hope substance abuse treatment program
* Minimum stay in treatment at House of Hope for 3.5 months
* Fluent in English

Exclusion Criteria:

* Psychosis
* Suicide risk
* Dementia
* Significant withdrawal risk
* Severe, unstable depression
* Requires intensive mental health treatment
* Cognitive impairment
Coronary CT Angiography Using a Novel 3rd Generation Dual-Source CT System

Coronary CT angiography is used to examine the coronary arteries in a non-invasive way when a patient is suspected of having coronary artery disease. The test, however, requires relatively high levels of radiation, which have been linked to DNA damage and cancer, and the use of contrast material, which can affect kidney function. The SOMATOM Force, a new third-generation CT scanner manufactured by Siemens, was recently installed at MUSC and holds the potential to obtain quality images while also reducing radiation dose and contrast material. This study aims to test the diagnostic ability of the SOMATOM Force in detecting coronary artery disease and also see if radiation dose and contrast material are reduced compared to the previous 2nd generation scanners. It is suspected that the Force will provide clinical quality images while decreasing radiation dose and contrast material required.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be between 18-90 years of age.
* Subject must have been referred for a clinically indicated cardiac catheterization or nuclear cardiac perfusion study.
* Subject must provide written informed consent prior to any study-related procedures being performed.
* Subject must be willing to comply with all clinical study procedures.

Exclusion Criteria:

* Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:

  * By testing (urine βHCG) within 24 hours before contrast agent administration, or
  * By surgical sterilization, or
  * Post menopausal, with minimum one (1) year history without menses.
* Subject has an acute psychiatric disorder or is cognitively impaired.
* Subject is using or is dependent on substances of abuse.
* Subject is unwilling to comply with the requirements of the protocol.
* Subject has decreased renal function (eGFR \<45)
* Subject has an allergy against iodinated contrast agents.
* Subject is in acute unstable condition.
Exploration of the Efficacy and Mechanisms of Lymphaticovenous Anastomosis in the Treatment of Alzheimer's Disease

The aim of this clinical trial is to determine whether Lymphaticovenous Anastomosis can treat Alzheimer's disease，in AD patients aged 18-80.he main questions it aims to answer are:

1. Can Lymphaticovenous Anastomosis improve cognitive function, daily living ability, mood, or sleep status in patients with Alzheimer's dementia, demonstrating good therapeutic efficacy?
2. Does deep Lymphaticovenous Anastomosis lead to changes in peripheral blood biomarker levels, neuroinflammatory responses, and neuroimaging in patients with Alzheimer's dementia?


Eligibility Criteria:
Inclusion Criteria:

1. At least two deputy chief physicians or above, diagnosed with Alzheimer's dementia according to the DSM-5 diagnostic criteria;
2. Age between 18-80 years old;
3. The course of the disease is at least 1 year;
4. MMSE score ≤ 24 points; MoCA score \< 26
5. Brain MRI shows hippocampal atrophy;
6. Patients and their families agree to participate in this project for surgical treatment and sign an informed consent form.

Exclusion Criteria:

1. Individuals with contraindications for Lymphaticovenous Anastomosis; those allergic to anesthetics and contrast agents (indocyanine green);
2. Those unable to cooperate with cranial magnetic resonance imaging and scale testing;
3. Patients simultaneously suffering from schizophrenia, depression, bipolar disorder;
4. Patients with severe somatic diseases (such as cardiovascular, liver, kidney, gastrointestinal, etc.), infectious diseases, and immune system disorders;
5. Individuals with serious neurological diseases (such as epilepsy, cerebrovascular diseases, etc.), other types of dementia, mental retardation;
6. Pregnant or lactating women.
Evaluation Of The Potential Effect That The Administration Of Food Or Antacid Medication May Have In The Oral Absorption Of Dacomitinib (PF-00299804)

Evaluation of the potential effect that the administration of food or antacid medication may have in the oral absorption of dacomitinib relative to the administration of dacomitinib in absence of food or antacid medication


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects including males between the ages of 18 and 55 years. Females of non childbearing potential .
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* An informed consent document signed and dated by the subject.

Exclusion Criteria:

* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen.
* Treatment with an investigational drug within 30 days (or as determined by the local requirement) or the appropriate time based on the elimination characteristics of the study medication.
Characterization of T-cell Repertoire in Patients With Acute Myeloid Leukemia Undergoing Donor Stem Cell Transplant

This research trial studies characterization of T-cell repertoire through next-generation sequencing in patients with acute myeloid leukemia undergoing stem cell transplant. Characterizing T-cell repertoire may help to understand if immune system plays a significant role in high risk patients with acute myeloid leukemia.

PRIMARY OBJECTIVES:

I. Characterize the T cell receptor (TCR) repertoire in acute myeloid leukemia (AML) patients before and after receiving hematologic stem cell transplantation (HSCT).

II. Identify molecular changes (germline variants and somatic mutations) that contribute to shaping the TCR repertoire.

OUTLINE:

Patents undergo collection of blood samples before, on day 100, and 1 year after HSCT. Donors undergo collection of blood at the time of HSCT for ribonucleic acid (RNA)-based next generation sequencing of TCRA and TCRB genes.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AML scheduled to undergo HSCT at University of Southern California (USC)

Exclusion Criteria:

* Inability to provide consent because of severe mental disorders
* Donor unwilling to provide consent
Role of the Protein Matrix in the Anabolic Response to a Ground Beef Patty as Opposed to the Impossible (Vegi-) Burger

Several of the investigator's recent studies have shown that all dietary proteins are not equal when it comes to making proteins in human bodies. Generally, foods made from animal muscle tissue are much more efficient at making new proteins in the body that those from plant sources. This study will measure the amount of protein growth in participants after consuming either one beef patty, one vegi-burger, or two vegi-burgers. By using stable isotope infusions and collecting blood and leg muscle samples, the investigator's lab can determine the rate of muscle metabolism that happens after a participant eats a protein-containing food. The investigator wants to determine if the vegi-burger is as efficient as the beef patty at creating proteins in a participants. The investigator will measure this metabolism over a 10-hour period, with the food being eaten at the 4 hour mark. The investigator plans to perform this procedure on up to 8 participants per food option (24 total).

According to the USDA Economic Research Service Food Availability Data, beef consumption has been on a general decline for the past 40 years, with current per capita consumption approximately 35% lower in 2020 than in 1980. Some of this decline over the past few years can be attributed to politically motivated claims that carbon emissions from cattle represent a major threat to the global environment. However, the major reason for declining beef consumption is the widely promulgated claim that beef is unhealthy. The hamburger in particular has become a poster child for the notion that beef consumption is responsible for the increasing occurrence of obesity in the United States. The trend of decreasing beef consumption due to perceived health concerns, particularly obesity and associated health problems, has led major fast-food chains such as Burger King and McDonalds, to offer vegetarian burgers as healthy alternatives to the traditional beef burger. However, examination of the components of the macronutrient matrix of a typical vegetarian burger gives reason to question the health benefits as compared to a traditional beef patty-hamburger.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 - 40 yrs.
* Body Mass Index of 20-32 inclusive

Exclusion Criteria:

* Unwilling to eat animal proteins
* History of diabetes that requires medication for control of blood glucose
* History of malignancy or chemo/radiation therapy in the 6 months prior to enrollment
* History of gastrointestinal bypass/reduction surgery (Lapband, gastric sleeve, etc.)
* Pregnant females
* Hemoglobin less than 12 g/dL at screening
* Platelets less than 150,000 at screening
* Subjects who cannot refrain from using protein or amino acid supplements for 7 days prior to Visit 3
* Concomitant use of oral or injectable corticosteroids
* Concomitant use of testosterone, IGF-1, or similar anabolic agent
* Any other disease or condition that would place the subject at increased risk of harm if they were to participate, at the discretion of the study physician
Follow-up Evaluation of Photo-Dynamic Therapy for Pituitary Tumours

A study to followup patients that have previously been treated for pituitary tumours with either photodynamic therapy or placebo in a previous trial. The study aims to determine whether photodynamic therapy has any long term effect on tumour size, visual fields or endocrinological function.

No patients will receive any medical or procedural treatments in this study, since these have been administered in a previous trial. The previous trial participants will be contacted and asked to attend a clinic or to have a telephone interview, where they will answer a questionnaire. They will be assessed clinically for visual fields, as well as undergoing an MRI scan of their head to assess tumour size (unless they have had a scan anyway in the previous 12 months), these tests would ordinarily form part of the routine outpatient workup for patients with pituitary tumours. There is no significant risk to the physical well-being of the patients with any of the methods to be used.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were previously included in the initial pituitary PDT trial, in addition to those who were randomised as part of the RCT arm of the study. These patients have already participated in phase I/II trials. Of note, these patients all have pituitary tumours.

Exclusion Criteria:

* Patients who were not included in the above mentioned trials. Patients included in the original trials who have subsequently died (of any cause).
Evaluation of Factors That Cause Secondary Brain Damage on Mortality and Morbidity in Patients Undergoing Emergency Surgery Due to Head Trauma.

Traumatic brain injury is combination damage that occurs as a result of a chain reaction of various metabolic events that develop after primary damage caused by trauma. Pathological events such as lactic acidosis, electrolyte imbalance, increased inflammation that occur during traumatic brain injury leads to poor prognosis in patients.

The retrospective study was conducted to investigate the effect of factors that may cause secondary damage, especially electrolyte imbalance and blood glucose levels, on mortality and morbidity in patients undergoing emergency surgery due to head trauma.


Eligibility Criteria:
Inclusion Criteria:

* patients who admitted to Bursa Uludag University hospital between 2013 and 2018
* patients diagnosed with traumatic brain injury and operated within the first 24 hours after admission

Exclusion Criteria:

* pediatric patients
* patients that operated after 24 hour of admission
Causes of Pneumonia in Yangon

This study will evaluate a new point of care diagnostic test for the diagnosis of melioidosis pneumonia in patients attending outpatient clinics in Yangon, Myanmar

Melioidosis is caused by Burkholderia pseudomallei, a Gram-negative saprophytic environmental bacterium that is an important emerging tropical infection. There are an estimated 165,000 cases and 89,000 deaths world-wide each year. Eighty-four percent of cases are in SE Asia where mortality is 40%; far exceeding most recognised neglected tropical diseases. Pneumonia, secondary to either inhalation of B.pseudomallei or to bacteraemic spread to the lung is the commonest presentation (51%). Annually the highest burden (75%) of infection occurs in the rainy season in (75% in Thailand). Up to 80% patients have at least one recognised risk factor for melioidosis including; diabetes, alcohol-dependence, glucocorticoid therapy, chronic obstructive pulmonary disease (COPD), chronic renal disease and cancer. COPD and diabetes mellitus are amongst the top ten causes of death in Myanmar (2018). Patients with HIV have not been shown to have greater risk of B. pseudomallei than immunocompetent patients.

Melioidosis was discovered in Myanmar in 1911 by British pathologist Alfred Whitmore and his assistant CS Krishnaswami. Yet since 1949 there have been few published cases. Under-reporting is partly due to difficulty in diagnosing melioidosis. Clinical and radiological findings are indistinguishable from tuberculosis. Laboratory diagnosis is challenging, lack of facilities, expertise and awareness of B.pseudomallei results in missed diagnostic opportunities.

Culture is the gold-standard diagnostic method but requires appropriate facilities and expertise which are not readily available in many developing countries like Myanmar. A rapid diagnostic (RDT) test has been developed for low resource settings that has been evaluated in Laos and India. The InBios® Active Melioidosis DetectTM-Lateral Flow Assay (AMD-LFA) detects B.pseudomallei 6-deoxyheptan capsular polysaccharide antigen. Shaw et al demonstrated sensitivity 85.71% (CI:74.61% to 93.25%) and specificity 93.62% (CI:88.23% to 97.04%), with positive predictive value of 85.71% (CI: 75.98% to 91.92%) compared to culture. We propose to evaluate this test for the diagnosis of melioidosis pneumonia in Myanmar.

Eligibility Criteria:
Inclusion Criteria:

1. \>18 years old
2. Reported fever or axillary temperature \> 37.5 °C
3. Productive cough
4. Written informed consent

Exclusion Criteria:

1. Inability to provide a sputum specimen
Topical Palm Tocotrienols on Blemish-prone Skin

A single-center, double-blind, randomised, placebo-controlled parallel-group study.

Selected subjects will be randomised into active and control groups in a ratio of 1:1. Investigational products assigned will be applied on the facial skin as part of daily skin care routine. The effects will be observed during the 12-weeks of use.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy individuals, aged 18 years and above
2. Fitzpatrick skin type II to IV
3. Blemish-prone skin with acne of severity grade 2 or 3 based on Comprehensive Acne Severity Scale (CASS)

Exclusion Criteria:

1. Has a history of chronic drug or alcohol abuse
2. Is a current smoker
3. History of severe allergic reactions to topical products or vitamin E
4. Participant with severe and uncontrollable comorbidities (including but not limited to e.g. diabetes, hypertension, kidney failure)
5. Pregnant, breastfeeding, or planning pregnancy
6. Participant with known skin conditions (including but not limited to e.g. sensitive skin, eczema and diseased skin e.g. contact dermatitis), uncontrolled medical conditions, or any other condition that could interfere with the study evaluations or increase risk to the participant (such as polycystic ovary syndrome and contact dermatitis)
7. Participant with compromised/broken skin, tattoos, scarring, excessive hair growth, very uneven skin tone, or other conditions that would interfere with evaluations or increase risk
8. Participation in another study within 4 weeks of screening visit
9. Has severe acne or acne conglobata
10. Use of systemic treatment for acne such as isotretinoin, contraceptive pills, or spironolactone within 4 weeks of screening visit
11. Use of topical treatments like antibiotics, corticosteroids, benzoyl peroxide, azelaic acid, salicylic acid, alpha hydroxy acids (AHAs), vitamins A (retinol) or C (ascorbic acid) or their analogs or derivatives and other anti-inflammatory drugs within 2 weeks of screening visit
12. Use of scrub, alpha-hydroxy acid (AHA), skin irritant products in the 2 days before study treatment start
13. Participant with active bacterial/fungal/viral skin infections or susceptibility to such infections within 2 weeks of Screening visit
14. Use oral antibiotics
Prevalence of Mental Health Disorders in Junior Anesthetists and Intensivists

Mental health disorders are rapidly growing nowadays and it is well known that people who are subjected to a long term stress are among the highly vulnerable group. Of those, doctors come first specially those working in anesthesia and ICU field owing to the nature of their work where heavy work load, exposure to occupational hazards and competitive environment predominate. More care is needed to identify the magnitude of the ongoing problem and to stand on its determinants to be able to prevent or treat the negative impact on their health and patients as well.

The mental health of physicians is a concern that is gaining popularity and international attention nowadays. Physicians are not immune to mental disorders and even we can say that they are more vulnerable. Mental disorders increases as stress increases, and working as a physician carries stressors like other highly skilled occupations and that unique to the medical field

Work demands are always high and the work environment is relatively poor with insufficient support. They work for long hours with little appreciation and more blaming. Many of them also share the feeling of mental illness stigma that keep them away from seeking help

Usually physicians face most of the stress in their first years of experience that require more learning and working time accompanied by more financial burden with more incidence of mental illness in those working in the frontline as anesthetists and intensivists. Common mental disorders that frequently affect junior anesthetists and intensivists include burn out, anxiety and depression .

Caring for the mental health of physicians goes beyond caring for a colleague, it is a requisite for a powerful functioning health system. Suffering from mental disorders may lead to more sick absences, less productivity, substance abuse and even suicidal thoughts. Patients are at risk of negligence and more medication errors. This requires structured approach to clarify the misinformation regarding physician well-being, and which individual or intervention that should be prioritized.

This is not an easy task as the problem is complex and needs systematic approach to know the magnitude of the problem in reality and study its determinants and put applicable solutions.

Eligibility Criteria:
Inclusion Criteria:

* working as anesthetist or intensivist
* working experience less than or equal 5 years

Exclusion Criteria:

* personality disorders
* psychiatric diseases