cyrilzakka/clinical-trials huggingface dataset:
Protecting With ARNI Against Cardiac Consequences of Coronavirus Disease 2019

The purpose of this study is to determine the effect of sacubitril/valsartan versus placebo on markers of cardiac injury, structure, and function among patients who recovered from acute COVID-19 infection.


Eligibility Criteria:
Inclusion Criteria:

1. Patient with a history of laboratory proven-diagnosis of COVID-19 who is 4-16 weeks from their last positive COVID-19 test
2. Systolic blood pressure ≥100 mmHg at screening
3. ≥18 years of age
4. Successful collection of baseline serum biomarkers
5. Successful completion of baseline EQ-5D questionnaire
6. Successful completion of baseline CMR study (CMR sub-study only)
7. High-sensitivity troponin T at or above the level of detection on screening labs
8. Presence of ≥1 of the following:

   1. Age ≥60
   2. History of atherosclerotic cardiovascular disease (ASCVD), including myocardial infarction, coronary artery disease, ischemic stroke/transient ischemic attack, or peripheral artery disease
   3. Diabetes mellitus (Type 1 or Type 2)
   4. Body mass index ≥35 kg/m2
   5. eGFR 30-60 ml/min/1.73m2
   6. History of atrial fibrillation/flutter

Exclusion Criteria:

1. Fever within the past 96 hours of \>100.3 degrees Fahrenheit
2. Actively receiving therapy with an angiotensin-converting enzyme inhibitor (ACEI), angiotensin II receptor blocker (ARB), aliskiren, or sacubitril/valsartan
3. Last known left ventricular ejection fraction of ≤40%
4. eGFR \<30 ml/min/1.73m2 on screening labs, including patients on dialysis therapy
5. Serum potassium \>5.0 mEq/L on screening labs
6. Prior intolerance, allergy or angioedema to ACEI, ARB, or sacubitril/valsartan
7. Pregnant or breast-feeding
8. In women of childbearing age, unwillingness to use birth control for the duration of the study
9. History of heart transplant or durable left ventricular assist device
10. Currently implanted permanent pacemaker, defibrillator, or other device that would preclude CMR testing (CMR sub-study only)
11. Currently participating in another trial of an investigational medication or device for COVID-19.
12. Any other condition that in the judgment of the investigator would jeopardize the patient's compliance with the study protocol
Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC

The primary goal of this study is to examine whether recurrence of HPV-associated OPSCC can be predicted by two factors: 1) mutations in genes called TRAF3 and CYLD, and 2) measurements of circulating HPV DNA in blood plasma. The study will also investigate whether HPV integration is associated with TRAF3 and CYLD mutations, and whether recurrence prediction improves when looking at HPV integration along with TRAF3 and CYLD mutations.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* T0-T2 N2a-N3 M0 or T3-T4 N0-N3 M0 (AJCC 7th edition)
* Biopsy proven squamous cell carcinoma of the oropharynx or unknown primary
* No prior therapy
* No evidence of distant metastatic disease
* p16 positive = diffuse ≥ 70% tumor cell expression, with at least moderate (2/3+) staining intensity
* Planned for receipt of definitive cancer treatment
* ECOG Performance Status 0-1
* Patients must be deemed able to comply with the treatment plan and follow-up schedule.
* Patients must provide study specific informed consent prior to study entry

Exclusion Criteria: All subjects meeting any of the exclusion criteria at baseline will be excluded from study participation:

* Prior history of radiation therapy to the head and neck
* Prior history of head and neck cancer.
* Inadequate pre-treatment tissue sample for tumor genomic analyses
Expression Analysis of the COPB 2 and Bcl-2 in Early Stages of Endometrial Carcinoma

COPB2 is a subunit of the intracellular transport system between cell organelles that participates in the regulation of cell division and differentiation. Bcl-2 is a protein that participates in regulating the process of apoptosis. Through the research,investigators tried to examine and establish the correlation of the expression of these two genes in endometrial cancer at an early stage.

The research was conducted as a prospective controlled clinical experimental study in the period from 2019-2022. in patients who were treated at the Gynecology and Obstetrics Clinic in Clinical Center Kragujevac. Sections of tissue deriving from the exploratory curettage and operative procedure were taken after obtaining informed consent of participants with the declaration of Helsinki and recommendations of the World Health Organization for experiments on human material and after getting approval of the Ethics Committee.

Participants are divided into two groups. Investigators stored the sample (endometrial tissue) in liquid nitrogen under adequate conditions at the Kragujevac Clinical Center, department for Gynecology and Obstetrics and examined the expression of the COPB2 and Bcl-2 gene in endometrial tissue cells of these two groups of patients. In order to examine the relative expression of the gene for the COPB2 subunit and Bcl-2, investigators sampled endometrial tissue from patients with endometrial cancer - experimental group and from patients without cancer - control group. All participants of the experimental group had initial stages of cancer, without the existence of metastases at the time of taking the sample for the study. Gene expression was performed using the Polymerase Chain Reaction method at the Faculty of Science and Mathematics in Kragujevac.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent of the patient
* pathohistological confirmation of endometrial carcinoma for the experimental group
* normal endometrial tissue and hyperplasia simplex endometrii for the control group.

Exclusion Criteria:

* malignant disease in the patient whose treatment is still ongoing
* pathohistological determination of atypical hyperplasia of the endometrial tissue
Immediate Postpartum Glucose Tolerance Testing

The objective of this study is to compare the accuracy of a 2hr glucose tolerance test administered during the postpartum hospitalization with the standard of care glucose tolerance testing (administered at 6 weeks postpartum). The primary hypothesis is that the glucose tolerance test administered in the postpartum period will be accurate and will improve compliance with postpartum testing for gestational diabetics.

Gestational diabetes affects approximately 5-10% of pregnancies and its prevalence continues to increase as rates of obesity and metabolic disease increase in reproductive age women. Women diagnosed with gestational diabetes carry an increased risk of developing type 2 diabetes later in life, even if their glucose tolerance initially normalizes following delivery.

The gold standard assessment of glucose tolerance postpartum is a two hour glucose tolerance test (GTT) that is completed between six and twelve weeks' postpartum. Unfortunately, the compliance rate with this test is low, ranging from 30 - 50% by most reports. As a result, a large number of women with glucose intolerance are missed due to noncompliance with postpartum testing, thereby forfeiting the opportunity for diagnosis, treatment and prevention of longterm health consequences. The postpartum hospital stay provides a unique opportunity to increase compliance with glucose tolerance testing due to an increased rate of patient capture. However, it is unknown if administration of a glucose tolerance test in the immediate postpartum period would adequately identify women with persistent glucose intolerance.

The current study aims to provide data towards the accuracy of an immediate postpartum GTT in a population of women with gestational diabetes and provide follow-up data on women with abnormal testing.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant or recently postpartum (postpartum day 0 or 1)
* ≥ 18 years of age
* Gestational age ≥34 weeks
* A1 or A2 gestational diabetes

Exclusion Criteria:

* Medical exclusion from completing glucose tolerance testing
* Steroid administration within 10 days prior to enrollment
* Chronic steroid use
Full Disclosure Observational Cardiac Rhythm Documentation Follow-up After Surgical Atrial Fibrillation Therapy

24 hour Holter monitoring (24HM) is commonly used to assess cardiac rhythm after surgical therapy of atrial fibrillation. This "snapshot" rhythm documentation leaves a large diagnostic window of non recorded atrial arrhythmias and as such a large amount of uncertainty in follow-up result assessment. To improve accuracy of rhythm surveillance thus gaining a more "real-life" scenario of post surgical ablation therapy cardiac rhythm a new insertable cardiac rhythm monitor device (Reveal® XT 9525, Medtronic Inc., Minneapolis, MN, USA) with full observational continuous heart rhythm documentation is implanted.

In order to verify different follow-up strategies after surgical atrial fibrillation therapy, a comparison of different follow-up scenarios (symptoms, different cardiac documentation devices i.e. ECG and 24 hour Holter monitor, at different follow-up time points) is performed intraindividually. Thus the reliability of these devices and follow-up strategies to define success after ablation therapy is evaluated.


Eligibility Criteria:
Inclusion Criteria:

* patients in atrial fibrillation (AF duration \>4 months)being scheduled for cardiac surgery
* patients with lone atrial fibrillation being scheduled for surgical AF treatment

Exclusion Criteria:

* failure to provide informed consent
* current participation in another clinical trial
* organic cause of atrial fibrillation (hyperthyroidism etc.)
The Effects of Yoga on Body Image in College Women

The purpose of this study is to assess the effects of a regular yoga practice on body image in college women.

A randomized controlled design will be used to study the effects of a regular yoga practice on body image in young adult women. Fifty female freshman, sophomores, and juniors between the ages of 18 and 26 years will be recruited from the University of Delaware student population, specifically targeting those new to yoga. Age, academic standing, availability and prior yoga experience will be evaluated.

Consented individuals will be randomized to one of two conditions: (1) yoga (offered 3 times per week) for 10 weeks; or (2) a control group. Baseline assessments, midpoint assessments, and end-of-study assessments will be conducted on all participants. Participants will be compensated for their attendance at assessment visits.

Eligibility Criteria:
Inclusion Criteria:

* Freshman, sophomore, or junior at the University of Delaware
* Available Spring 2017 on Mondays, Wednesdays, and Fridays from 1:25-2:15pm
* Physically able to participate in yoga

Exclusion Criteria:

* Females who are seniors at the University of Delaware (This is because participants in the control condition will be given a pass to participate in group fitness at the end of the study, and would not be able to use this incentive if they are seniors)
A Single-Blind, Placebo-Controlled, Dose-Ranging Trial of Oral HDV-Insulin in Patients With Type 2 Diabetes Mellitus

A study designed to determine the appropriate doses of Oral HDV Insulin at meal times.


Eligibility Criteria:
Inclusion Criteria:

Patients must satisfy all of the following inclusion criteria to be included in the study:

1. be male or female between the ages of18 and 65 years, inclusive;
2. have a current diagnosis of type 2 DM, which is currently managed with oral hypoglycemic agents for at least 3 months;
3. have a current physical examination that reveals no clinically significant abnormalities;
4. have no clinically significant abnormalities in vital signs;
5. have a body mass index (BMI) \<38;
6. have a glycosylated hemoglobin (HbA1c) \> 8 and \<12;
7. have a C-peptide level \>3 ng/mL;
8. have a typical fasting blood glucose levels of \< 200 mg/dl (+/- 25 mg/dl);
9. be available for the entire study period, and be able and willing to adhere to protocol requirements;
10. if female of childbearing potential, must be using a reliable form of birth control; and,
11. provide written informed consent prior to admission into the study.

Exclusion Criteria:

1. have a history or presence of significant cardiac, gastrointestinal, endocrine, neurological, liver, or kidney disease, or conditions known to interfere with the absorption, distribution, metabolism, or excretion of insulin;
2. have a history of drug or alcohol dependency or psychological disease;
3. have any clinically significant illness during the 4 weeks prior to admission into the study;
4. require regular use of medication that interferes with the absorption and/or metabolism of insulin;
5. recent use (within 48 hours) of medications that interfere with blood glucose analyses, i.e., mannose, acetaminophen, dopamine, and ascorbic acid, which are all reported to alter glucose-oxidase type blood glucose analytical methods;
6. use of Avandia or Actos for treating diabetes;
7. participation in a clinical trial or use of an investigational drug within 30 days prior to admission to this study;
8. use of MAO inhibitors or enzyme-inducing or enzyme-inhibiting agents (eg, phenobarbital or carbamazepine) within 30 days prior to admission to this study;
9. are pregnant or lactating; 10. have an episode of severe hypoglycemia with seizure or coma within the past year;

11. have a history of ketoacidosis;

12. have any acute illness within 2 weeks prior to Screening; or,

13. have elevated liver enzymes (ALT, AST, alkaline phosphatase) \>1.5 times the upper limit of normal.
Increasing Teen Access to Sexual and Mental Health Care

Investigators will form community partnership with community sites that will disseminate curated educational information on Sexual and Reproductive Health/Mental Health (SRH/MH). Investigators will attend a series of outreach events hosted by community partners community and community leaders that provide/demonstrate telemedicine and the Children's Mercy Mobile Unit which is equipped to provide direct patient care. Investigators will engage up to 40 teen peer leaders to encourage healthcare-seeking behaviors and mobilize their social networks to attend outreach events. At all events, the mobile unit will be available for teens to (a) demonstrate the mobile; (b) learn about Sexual and Reproductive Health/Mental Health (SRH/MH) and local care resources; (d) acquire free over-the-counter emergency contraception, birth control, condoms, and pregnancy tests.

AccessKCTeen is a pilot clinical outreach program that uses Children Mercy's Mobile Unit and Telemedicine to demonstrate and increase access to SRH and MH.

AccessKCTeen intends to focus on these central activities:

1. Education based on a peer-leader model: In collaboration with community-based partners, investigators will identify and train approximately 40 peer leaders in disseminating information and resources for Sexual and Reproductive Health/Mental Health (SRH/MH) MH/SRH to their social networks. Peer leaders may disseminate information in the form of sharing curated online resources or mobilizing friends to attend live educational events. Peer leaders will also help connect their friends to resources by spreading information and encouraging friends to attend CM mobile unit demonstrations. Investigators will use text messaging to engage peers in these educational events and share general health resources.
2. Mobile Unit and Telemedicine Demonstration Events: The mobile unit will be present at community events to demonstrate how in-person care could work on the unit as well as how telemedicine works. Investigators will answer questions and help adolescents get registered for telemedicine.

Eligibility Criteria:
1. INTERVENTION TRIAL PARTICIPANTS and Peer Leaders (ADOLECENTS) Inclusion Criteria

   * Aged 14-18 years and 364 days old

     a. Exclusion Criteria
   * Younger than 14 years old or older than 18 years and 364 days at the time of enrollment
   * Does not speak/understand English
   * Not recruited from an already nominated or enrolled adolescent
2. Event Day Trail PARTICIPANTS (ADOLECENTS) Inclusion Criteria

   * Aged 14-18 years and 364 days old

     a. Exclusion Criteria
   * Younger than 14 years old or older than 18 years and 364 days at the time of enrollment
   * Does not speak/understand English
   * Not recruited from an already nominated or enrolled adolescent
Effects of High Load Strength Training With and Without Tissue Specific Planter Facia Stretching With Planter Fasciitis

The rationale behind examining the synergistic impacts of high load strength training and tissues pecific plantar fascia stretching activities in athletes diagnosed with plantar fasciitis arises from an acknowledged deficiency in the existing body of scholarly research.Study design will be Randomized Control Trial. The study will be completed in 10 months after Synopsis Approval.The study will be carried in sports clubs of MOTH Mirpur AJK. Convenient Sampling will be used. Data Collection Tools will be used named as VAS, Functional foot index (FFI), and Goniometry used for Pain, functional disability and range of motion will be measured respectively before and after the intervention

Population is divided into 2 groups: Group A and Group B. Both groups will be given a patient evaluation sheet and thickness of planter fascia will be already measured by Ultrasound. Group A will then receive high load strength training and routine physiotherapy. Group B will receive high load strength training and Tissue-specific plantar fascia stretching exercise and routine physiotherapy. Pain, range of motion and functional disability will be measured before session, immediate effect after first session, then after 06 weeks (18 session) with high load strength training maximum repetition 12 RM with 3 sets in alternative days in each set minimum 2 mint rest interval and tissue specific plantar fascia stretching exercise perform for 10 times for 10 sec, after 12 weeks (36 sessions) with high load strength training maximum repetition 10 RM with 4 sets in alternative days in each set minimum 2 mint rest interval tissue specific plantar fascia stretching exercise perform for 10 times for 10 sedate will be entered and analyzed by SPSS version 21. Statistical significance will be p=0.05 Descriptive statistics: Frequency tables, pie charts, bar charts will be used.

Eligibility Criteria:
Inclusion Criteria:

* Only Male Athletes
* Prediagnosed Patients suffering from Plantar fasciitis referred from Orthopedic.
* History of inferior heel pain atleast 2 weeks before enrollement.
* Pain on palpation of Medial calcaneal Tubercle/proximal Plantar Fascia.
* All participants with in the age group between 20-35 yrs.
* Patients who are willing to particiapate in the study.
* Heel pain syndrome

Exclusion Criteria:

* History of any systemic disease
* Heel and skin infection
* History of prior Surgery
* Corticosteroid injection for Plantar fasciitis within previous 06 momths;
* Any known malignancy /neoplasma involved side.
* Diagnosed/known psychiatric illness
Immune Status in Solid Organ Transplantation

Immunosuppressive therapy protocols in solid organ transplantation are rudimentary, differ by transplant center and no practical strategies are available to guide an individuals' response to immune suppression. In this study we will conduct research to assess immunologic status in solid organ transplant recipients, predicting immune reconstitution and outcomes after transplant to better guide the use of immunosuppressive medications.


Eligibility Criteria:
Inclusion Criteria:

* Impending kidney transplant
* Age \>18
* Able to provide informed consent and comply with the study procedures

Exclusion Criteria:

* Age\<18
* Concomitant illness, which by decision of investigator, may compromise the ability to perform this trial
Cognitive Fusion Prostate Biopsy With Biparametric Magnetic Resonance in the Detection of Prostate Cancer

The goal of this prospective observational study is to evaluate the diagnostic precision of the Biparametric Magnetic Resonance Imaging (bpMRI) in the detection of clinically significant prostate cancer (PCa) in patients with biochemical suspicion of prostate cancer with PSA (Prostate Specific Antigen) \> 4 ng/mL and a normal digital rectal examination and without a biopsy previous to the MRI. Secondary aims are:

* Determine the validity as a diagnostic test of the first directed transrectal prostatic biopsy (cognitive fusion) versus systematic biopsy of 12 cylinders in patients with suspicious lesions in the bpMRI.
* Develop a predictive nomogram that permits the reduction of the number of prostatic biopsies performed to patients with a low suspicion of prostate cancer in the bpMRI.

In Spain, PCa is the most common cancer independently from gender and the third cause of death in man, below lung and colorectal cancer. Incidence and mortality increase progressively as age increases, hence, due to an older population, this is an outstanding sociosanitary concern.

PCa generally is asymptomatic, diagnosis is based on prostate biopsy in man with an elevated Prostate Specific Antigen (PSA) in blood test and/or a pathologic digital rectal examination.

Multiparametric Magnetic Resonance Imaging (MRImp) plays an important role in the diagnosis. It allows the visualization of the tumor, it values its agresitivity with a scale named "Prostate Imaging-Reporting and Data System" (PI-RADS v2 scale), and permits a directed biopsy to the suspicious lesion.

This tecnique is expensive and very uncomfortable for the patient due its duration (40 minutes) and because it uses intravenous (iv) contrast. Due to these reasons, it is difficult to assume by the sanitary system to perform this technique to every patient with PCa suspicion.

Biparametric MRI emerges as an alternative with a new protocol, performed with less image sequences (T2 and diffusion), cheaper, lasting less (just 15 minutes), and without the administration of iv contrast. Thus, this technique is more assumable by a public sanitary system.

Eligibility Criteria:
Inclusion Criteria:

* Male patients between 18 and 80 years
* BpMRI performed in a 3 months period before the prostatic biopsy
* First transrectal prostatic biopsy
* PSA \> 4 ng/mL and \< 20 ng/mL
* Patients acceptance to participate in the study signing a written specific informed consent

Exclusion Criteria:

* Not having all the inclusion criteria described
* Suspicious digital rectal examination of prostate cancer
* Previous urinary tract infection in the last six months, acute urinary retention or being a chronic carrier of bladder catheter
* Previous prostatic surgery in any of its variants
* Concomitant treatment with Luteinizing hormone-releasing hormone (LHRH) analogue, antiandrogens or 5-alfa-reductase inhibitors
Pulmonary Functions in Sickle Cell Disease: Response to Acu-TENS

pulmonary complications are common in sickle cell disease patients. Respiratory training using inspiratory muscle trainer (IMT) is usually a good choice to improve these complications. Recently, acupuncture like transcutaneous electrical nerve stimulation (AC-tens) may also improve these complications.

sickle cell disease patients whose number will be forty patients will be divided to group I who will trained with IMT (threshold inspiratory muscle training) and treated with AC-tens (the number of patients will be 20) or group II who will trained with IMT (the number of patients will be 20) . The number of sessions per week will be three sessions for IMT or AC-tens for 12 weeks. the IMT will be performed for six sets of respiratory training cycles and the set will contain 10 respiratory cycles. Also the session of AC-tens will be 45 minute on bilateral Ex-B1 acupoint. the parameters of AC-tens will be four hertz and 200 microsecond pulse duration.

Eligibility Criteria:
Inclusion Criteria:

* sickle cell disease patients
* non obese patients

Exclusion Criteria:

* patients with any systemic or chest or renal or hepatic or neurological diseases
* women with lactation or pregnancy
* patients atacks of vasoocclusive crisis