cyrilzakka/clinical-trials huggingface dataset:
A 48 Week Observational Study of the Frequency of Symptomatic Herpes Virus I and II in HIV Infected Subjects

This study is an observational, cohort, prospective study looking at the frequency of Herpes Simplex Virus (HSV) 1 and or 2 outbreaks in HIV positive patients who's HIV virus is controlled on highly active anti-retroviral therapy. We will be enrolling fifty (50) patients.

We will be confirming that the patients are HIV positive and has antibodies to either HSV 1 or HSV 2 as part of the screening process. If so, we will then obtain patient baseline HIV-PCR, CD4, medial history including medications on day one. Whether the patient is on any or no herpes controlling medication. If the patient has what they feel is a flare up of HSV, they will come into clinic where the lesion will be culture and the patient's HIV-PCR and CD4 will also be obtained. Otherwise, the patient will receive phone follow ups every three months to see if there has been and change in their health or medications. The main endpoint is to see if there is a correlation between outbreaks in HIV patients and their CD4 cells and/or HIV and/or Herpes medication.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must be 18 years or older at the time of screening
2. Males, Females, Transgender Male and Transgender Females
3. HIV positive
4. Positive antibody to HSV- 1/and or HSV-2
5. If Female of child baring potential, documented negative pregnancy test at the time of screening.

Exclusion Criteria:

1. Active opportunistic infection
2. Current chemotherapy
3. Unable to give informed consent
Study to Investigate the Efficacy of Abrocitinib in Adult Participants with Severe Fatigue from Post COVID Condition/Long COVID

The primary purpose of this phase 2a study is to compare the efficacy of abrocitinib to placebo in improving severe fatigue in non-hospitalized adults with symptomatic Post-COVID Condition (PCC) (also called Long COVID). We are also interested in learning if abrocitinib is effective in improving overall health status in people suffering from severe fatigue from PCC. Eligible participants with a confirmed history of COVID19 infection who also have PCC according to the World Health Organization definition, will be randomized to receive abrocitinib at a dose of 50 mg, 100 mg, or placebo by mouth daily for 12 weeks (84 days).

Eligible volunteers will participate in six in-person visits over 4 months. These visits include review of medical and medication history, answering questionnaires, blood, urine, and nasal swab specimen collection, physical exams, and contraceptive and medication counseling.

Eligibility Criteria:
Inclusion Criteria:

* History of confirmed COVID-19 infection
* PCC diagnosis according to the WHO definition as occurring in individuals with a history of probable or confirmed SARS CoV-2 infection, usually 3 months from the onset of COVID-19 that lasts for at least 2 months and cannot be explained by an alternative diagnosis
* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
* Capable of giving signed informed consent

Exclusion Criteria:

* Participants with acute and chronic infections, history of specific recurrent infections
* Suspected or confirmed active SARS-CoV-2 infection within past 30 days
* Some cardiac conditions
* Current or former tobacco smoker within the last 12 months
* Known to be infected with Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C, Herpes Virus, or Tuberculosis
* History of immunodeficiency
* Blood clotting conditions
* Must meet general screening laboratory criteria
* Allergy or other contraindication to any of the components of the study intervention
* Known prior participation in this trial or other trial involving abrocitinib
* Concurrent therapy with a JAK or TYK2 inhibitor
* Other protocol criteria apply
Corneal Endothelial Cell Injury Induced by Mitomycin-C

our study will investigate the effecacy of Mitomycin-C in TransEpi single step photorefractive keratectomy (PRK) and alcohol assisted PRK


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years.
* Primary myopia or compound myopic astigmatism.
* Preoperative manifest refraction spherical equivalent (MRSE) within the range of -1.0 to 8 D
* Stable refractive error for at least 12 months before the surgery.
* Contact lens discontinuation for at least 3 weeks.
* Estimated corneal stromal bed thickness of more than 300mm at the thinnest point

Exclusion Criteria:

* Unwilling to participate in the study.
* Previous ocular surgery
* Any diagnosed ocular disease
* History of ocular trauma
Young, Empowered & Strong (YES): The Young Women's Breast Cancer Study 2- Focus on Intervention Pilot

This research study is piloting a new internet-based research tool (YES portal). The main purpose of this pilot study is to test the web-based interface.

This study is being done to pilot a web-based research intervention tool. The investigators hope that by piloting it with the participants they can improve the tool and the other processes. The main purpose of this pilot study is to test the web-based interface, the participant's engagement with the platform, and the recruitment procedures. This initial pilot study will inform the design of a larger study intended to monitor common symptoms and behavior, and to provide supportive care information and research opportunities in an iterative manner for young women who have been diagnosed with breast cancer using the YES portal, built for smartphones, tablets, and computers.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Between the ages of 18-44 years
* A history of breast cancer; we will pilot in 3 separate cohorts consisting of 10 patients each: newly diagnosed patients receiving care at DFCI, prevalent survivors who have completed early active therapy (surgery, chemotherapy and/or radiotherapy) and are being followed at DFCI, and women living with advanced breast cancer receiving care at DFCI
* Be fluent in and able to read English
* Have internet access on a regular basis at the time of consent that can support the web-based platform

Exclusion Criteria:

N/A
Citrulline Allo. Evaluation of Citrullinemia as a Marker of Bowel Damage After Allogeneic Bone Marrow Transplantation in Children

determine the interest of the dosage of citrullinemia to monitor the bowel damage after allogeneic bone marrow transplantation in children.

30 children included. Dosage of citrullinemia on day -7, day 0 and every week up to 100 days after BMT. Histological examination and extensive infectious screening in case of persistent digestive symptoms (more than 3 days).

Two groups of patients regarding on digestive involvement. Comparison of the values of citrullinemia between these two groups.

Eligibility Criteria:
Inclusion Criteria:

* 0 to 18 years
* allogeneic bone marrow transplantation for malignant or benign disease
* affiliation to French sécurité sociale
* parent's consent

Exclusion Criteria:

* severe gastro-intestinal involvement before transplant
* previous digestive surgery
Hypertension DASH Diet and Salt Free Diet

Background: In the management of hypertension lifestyle changes are recommended along with pharmacological treatment.

Aims: This randomized controlled intervention study aimed to compare the effects of a Dietary Approaches to Stop Hypertension (DASH) diet and a salt-free diet on blood pressure in hypertension patients. Methods: This study was conducted with 60 patients with primary hypertension. One group (n=30) was given an individualized DASH diet, the other group was given a salt-free diet (n=30), and the participants were followed for two months. The patients' blood pressures were monitored daily throughout the study, and their biochemical parameters were monitored at the beginning of the study, in the first and second months.

This study, which was planned as a randomized controlled intervention study, was conducted to compare the effects of the Dietary Approaches to Stop Hypertension (DASH) and salt-free diet on blood pressure in patients with hypertension. The study was complited with the participation of 60 hypertensive individuals (46 females, 14 males) who applied to between July 2019 and March 2020. Patients with hypertension who were living in Kayseri province, at least elementary school graduate, in the 20-65 age group, able to communicate with the researcher face to face and by phone, diagnosed with hypertension at least 4 weeks ago, and whose medication did not change were included in the study. One group (n = 30) received the DASH diet and the other group received a salt-free diet (n = 30) and was followed for 2 months. Research data was repeated during application with the face-to-face interview method. Research data was collected through a questionnaire containing questions about the sociodemographic characteristics, nutritional habits, chronic diseases, and medications of the individuals. Anthropometric measurements of the patients were made and blood and urine samples were taken. Food consumption frequency was noted, DASH diet compliance scale and International Physical Activity Questionnaire (IPAQ) short form were applied.

Eligibility Criteria:
Inclusion Criteria:

* Hypertension at least four weeks prior and had not changed their drug regimen in the previous four weeks
* 20-65 age group
* At least primary school graduate
* Able to express himself verbally
* Volunteer to participate in the dietary intervention
* Able to communicate with the researcher face to face and by phone

Exclusion Criteria:

* Those with chronic diseases other than cardiovascular diseases (such as Type II diabetes, kidney disease, cancer disease)
* Using alcohol or smoking
Assessment of the Relative Increase in Bioavailability of (Non-) Nutrients From a Mixed Salad by Adding Fat Containing Dressing

The hypothesis will be tested that fat can also increase absorption of (non)-nutrients from a salad. Therefore we designed the current study to show an increase in relative absorption (bioavailability) of (non-) nutrients from a mixed salad by adding fat containing dressing.


Eligibility Criteria:
Main inclusion Criteria:

* Body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2.
* Apparently healthy: no medical conditions, no use of prescribed or over the counter drugs, which might affect study measurements (as judged by study physician)
* Haemoglobin within normal reference range as judged by the study physician.
* Total cholesterol, LDL cholesterol, HDL cholesterol and fasting triglycerides within the normal reference range, as judged by the study physician.

Main exclusion Criteria:

* Reported use of any medically- or self-prescribed diet at the moment of screening, or the intention to use any kind of diet in the period between screening and the end of the study.
* Reported weight loss or gain ≥ 10 % of bodyweight during a period of six months before screening.
* A known food allergy or intolerance.
* A dislike to the foods supplied during the study.
* Use of vitamins or supplements enriched with carotenoid and/or vitamin A and/of vitamin K.
* Known hypothyroidism or hyperthyroidism.
Treatment Patterns in Gastrointestinal Stromal Tumors in the Community Oncology Setting

This is a retrospective medical record abstraction to evaluate the patterns of care for Gastrointestinal stromal tumors (GIST) in the community setting. Patient demographics and characteristics along with the treatments received will be described. Investigators will establish the percentage of patients who undergo surgery, the percentage of patients who are treated with kinase inhibitors as well as in what setting (adjuvant or metastatic) as well as the duration of therapy. Physician information will also be collected to assess for differences in treatment based on physician or geographical differences.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with GIST based on ICD-9 code from January 2005 to present will be eligible. This will include current active patients as well as patients who have expired and have medical chart available.
Bariatric Surgery and Exercise Interventions: Effects on Muscle

The purpose of this project is to assess the effects of bariatric surgery on muscle structure and function as well as investigating the feasibility of undertaking an exercise intervention post-surgery.

A single-centre feasibility research programme based at the Royal Derby Hospital centre of the University of Nottingham. This is an exploratory and feasibility study. Muscle structure and function of 12 patients will be assessed before bariatric surgery and at 6 weeks, and then 10 weeks, after surgery. After 6 weeks, participants will be randomised into two groups. Group 1 will undergo a 4 week Resistance Exercise Training (RET). Group 2 will undergo standard care procedure. The total duration of programme we are aiming for is 13-14 weeks prior to bariatric surgery and exercise intervention for 4 weeks after bariatric surgery.

Eligibility Criteria:
Inclusion Criteria:

* Obese adults (BMI greater than or equal to 35 kg/m2)
* Age range 18-70 years old
* Scheduled for RYGB surgery or sleeve gastrectomy surgery.
* Ability to give informed consent

Exclusion Criteria:

* Patients who are not fit or not suitable for RYGB or Sleeve Gastrectomy as per Tier 4 Bariatric Surgery MDT.
* For those high-risk patients who are fast tracked to surgery, we will exclude patients with a NYHA \>3 or 4 heart failure status and those with end stage renal failure.
* BMI greater than or equal to 60
Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone in Healthy Volunteers

The purpose of this study is assess the safety and bioequivalence of a single oral dose of carbidopa+levodopa+entacapone combination versus a single oral dose of carbidopa+levodopa combination plus a single oral dose of entacapone under fasting conditions in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects age 18 to 55 years of age included, and in good health
* At Screening, and Baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed after the subject has rested for at least five (5) minutes, and again when required after three (3) minutes in the standing position. Vital signs should be within the normal ranges
* Body mass index (BMI) within the range of 18 to 27 and weigh at least 50 kg
* Female subjects must have undergone hysterectomy, or must be postmenopausal.

Exclusion Criteria:

* History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
* History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
* Receiving monoamine oxidase (MAO) inhibitors within 28 days prior to the first dose
* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
* History of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug.
* Significant illness within two weeks prior to dosing
* Subjects who, through completion of the study, would have donated in excess of: 500 mL of blood in 14 days; 1500 mL of blood in 180 days; 2500 mL of blood in 1 year.
* History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
* History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
* Women of child bearing potential ( WOCBP)
* History or presence of glaucoma or any suspicious undiagnosed skin lesions

Other protocol-defined inclusion/exclusion criteria may apply
Evaluating the Effect of Perioperative Caloric Restriction Program on Perioperative Outcomes in Patients With Obesity and Endometrial Cancer

80% of endometrial cancer patients are overweight or obese. Preclinical and clinical data have shown that caloric restriction (CR) protects against organ injury and decreases perioperative morbidity. This is a feasibility trial to evaluate the effect of a 6 week perioperative CR on surgical and patient-reported outcomes in 20 obese newly diagnosed endometrial cancer patients. The intervention will provide individualized CR program, meal replacement products and nutritional counselling sessions.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed with Endometrial Cancer
* BMI30 kg/m2
* 18 year of age or older
* Scheduled for definitive surgical intervention (hysterectomy, bilateral salpingoopherectomy with or without lymphadenectomy) in the following 2-3 weeks as part of the standard of care
* Have ECOG performance status of 0-1
* Have a life expectancy of at least 1 year

Exclusion Criteria:

* Inability to communicate in English
* BMI30 kg/m2
* Age18
* Have any uncontrolled serious medical or psychiatric conditions that would affect their ability to participate in an intervention study, (e.g., severe/uncontrolled diabetes mellitus, severe cardiac and/or pulmonary disease and/or depression)
* Diagnosed with any other invasive malignancy currently, in the last five years or expected to undergo active treatment with either cytotoxic chemotherapy or radiation during the 6 week caloric restriction period
CATS Tonometer IOP Reduction Latanoprost Verses Timolol

Topical Prostaglandin Analog vs Betablocker - Corneal Biomechanical Evaluation using CATS Tonometer Prism

This clinical trial is a prospective, controlled, study and will be performed at one clinical investigative site in Tucson Arizona1. The purpose of this study is to determine if the device, CATS tonometer prism, measures intraocular pressure significantly differently than the current standard of care tonometer prism (Goldmann) before and after institution of topical prostaglandin analogs (PGA) for glaucoma treatment. Fifty percent of patients will be randomly placed on topical beta blockers as a control. The difference PGAs and beta blockers would be a measurement of the amount of corneal biomechanical changes made due to the PGA controlled for the effect of IOP lowering by the beta -blocker group.

Eligibility Criteria:
Inclusion Criteria:

* • Male and female patients, at least 18 years of age

  * Subject has a clear understanding and agrees to all the conditions of the informed consent form

Exclusion Criteria:

* Subjects shall be selected in accordance with the following exclusion criteria

  * Subject has undergone ocular surgery within the last 3 months
  * Uncontrolled systemic disease that in the opinion of the Investigator would put the subject's heath at risk
  * Pregnant or nursing women
  * Those who have had corneal surgery including corneal laser surgery
  * Microphthalmos
  * Buphthalmos
  * Severe Dry eyes
  * Lid squeezers - blepharospasm
  * Nystagmus
  * corneal or conjunctival infection.
The Effect of Sevoflurane on Haemodynamics

Cardiac output (CO) is measured using Mostcare. Mean systemic filling pressure (MSFP) and vascular resistances are calculated using venous return curves constructed by measuring steady-state arterial and venous pressures and cardiac output (CO) during inspiratory hold manoeuvres at increasing plateau pressures. Measurements are performed at three incremental levels of targeted sevoflurane concentrations.

Tracheal intubation is performed after anesthesia induction with sevoflurane. Radial arterial is cannulated and pressure transducer is connected to MostCare (core technique PRAM). HR, MAP, CVP, CO, SVR, PPV, and dp/dt are recorded at three incremental levels of targeted sevoflurane concentrations. MSFP and vascular resistances are calculated.

Eligibility Criteria:
Inclusion Criteria:

* American Association of Anesthesiologists (ASA)physical status score I-III
* major elective surgery that dictates the use of invasive hemodynamic monitoring including CVP and continuous arterial blood pressure monitoring.

Exclusion Criteria:

* symptomatic peripheral vascular disease or pulmonary disease
* aberrant cardiovascular anatomy
* significant valvular regurgitation
* severe arrhythmia
A Study to Evaluate the Effect of JNJ-53718678 on the Cardiac Repolarization Interval in Healthy Adult Participants

The purpose of this study is to assess the effect of JNJ-53718678 on QT interval corrected for heart rate (QTc) changes using exposure response analysis in healthy adult participants (Part 2).


Eligibility Criteria:
Inclusion Criteria:

* Participants must have a Body mass index (BMI) between 18 and 30 kilogram per square meter (kg/m\^2) (inclusive), and body weight not less than (\<) 50 kg at screening
* Participants must have a blood pressure between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic at screening
* Participants must have a 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function at screening, including: a) Normal sinus rhythm (heart rate (HR) between 45 and 100 beats per minute (bpm), inclusive); b) QT interval corrected for HR according to Fridericia's formula (QTcF) between 350 milliseconds (ms) and 430 ms for male participants, and between 350 ms and 450 ms for female participants (inclusive); c) QRS interval of ECG \<110 ms; d) PR interval of the ECG less-than or equal to (\<=) 200 ms; e) Morphology consistent with healthy cardiac conduction and function
* A female participant must be of non-childbearing potential, defined as: a) Postmenopausal or b) Permanently sterile
* A female participant must have a negative serum beta-human chorionic gonadotropin (b-hCG) pregnancy test at screening and a negative urine pregnancy test (except if postmenopausal) on Day -1 (or Day -2 in the first treatment period in Part 2)

Exclusion Criteria:

* Participants has a history of current clinically significant medical illness or certain laboratory abnormalities at screening
* Participant has a history of hepatitis A virus immunoglobulin M (IgM) antibody, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody positive, or other clinically active liver disease, or tests positive for hepatitis A virus IgM antibody, HBsAg or HCV antibody at screening
* Participants with unusual T wave morphology (such as bifid T wave) likely to interfere with QTc measurements
* Participants with a past history of heart arrhythmias or with a history of risk factors for Torsade de Pointes syndrome (for example, hypokalemia or family history of short/long QT syndrome, or sudden unexplained death at a young age \[\<=40 years\], drowning or sudden infant death in a first degree relative \[that is, sibling, offspring, or biological parent\])
* Participants with any skin condition likely to interfere with ECG electrode placement or adhesion