cyrilzakka/clinical-trials huggingface dataset:
Changes in DNA After Radiation Therapy in Patients With Prostate Cancer

RATIONALE: Collecting and storing samples of tissue from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA after radiation therapy and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at changes in DNA after radiation therapy in patients with prostate cancer.

OBJECTIVES:

Primary

* Demonstrate the feasibility of acquiring specimens, both frozen and paraffin-embedded, to yield RNA of adequate quality to perform DNA microarray studies on markers of radiotherapy outcome in patients with intermediate-risk prostate cancer.

Secondary

* Compare the gene expression results from frozen tissue and paraffin-embedded tissue to see the correlation between the 2 methods in patients treated on the brachytherapy alone arm of protocol RTOG-0232.
* Find genes that are expressed differentially before and after radiation therapy in patients treated on the brachytherapy plus external-beam radiation therapy arm of protocol RTOG-0232.
* Find gene expression patterns in patients treated on either arm of protocol RTOG-0232 who have significant associations with biochemically as well as clinically apparent local and distant failure.

OUTLINE: This is a multicenter, pilot study.

Frozen and paraffin-embedded tissue samples are studied for biomarker/laboratory analysis. DNA microarray analysis is performed on the samples to assess markers of radiotherapy outcome.

PROJECTED ACCRUAL: A total of 156 patients will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed, locally confined adenocarcinoma of the prostate
* Zubrod performance 0-1
* Clinical stages T1c - T2b, N0, M0
* Combined Gleason score 7 if prostate specific antigen (PSA) \< 10, combined Gleason score \< 7 if PSA 10 - 20; PSA must be ≤ 20 ng/mL, before hormone therapy, if given, and a prostate volume by transrectal ultrasound (TRUS) ≤ 60 cc.
* American Urological Association (AUA) score ≤ 15 (alpha blockers are allowed).
* Age ≥ 18 years old and must sign a study-specific informed consent form

Exclusion Criteria:

* No clinically or pathologically involved lymph nodes
* No distant metastases or significant obstructive symptoms
* No prior chemotherapy, pelvic radiation, transurethral prostatectomy (TURP), cryosurgery, TUNA, transurethral microwave thermotherapy (TUMT) or radical surgery for carcinoma of the prostate is allowed.
* No previous hormonal therapy beginning \< 2 months or \> 6 months prior to registration is allowed.
* No previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers unless the patient is disease free for ≥ 5 years.
* No hip prosthesis or major medical or psychiatric illnesses are allowed. prior to study entry.
Effect of Airway Pressure Release Ventilation on Right Ventricular Function Assessed by Transthoracic Echocardiography

Effects of APRV on right ventricular function in patients with acute respiratory distress syndrome by transthoracic echocardiography

Effects of APRV on right ventricular function in patients with acute respiratory distress syndrome(ARDS) by transthoracic echocardiography，which includes TAPSE, S' by TDI, RV FAC, tricuspid regurgitation,RVEDA/LVEDA,RV, Velocity time integration(VTI) of the left ventricular outflow tract blood flow.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who meet the 2012 Berlin ARDS diagnostic criteria and undergo invasive mechanical ventilation
2. PEEP≥5cmH2O, oxygenation index≤200mmHg
3. Endotracheal intubation and mechanical ventilation time \<48h
4. Age ≥18 years old and ≤80 years old

Exclusion Criteria:

1. Aged less than 18 years old or older than 80 years old
2. Obese patients with BMI≥35kg/m2;
3. Pregnant and lactating women
4. The expected time of invasive mechanical ventilation is expected to be less than 48h
5. Neuromuscular disease known to require prolonged mechanical ventilation
6. Severe chronic obstructive pulmonary disease
7. Intracranial hypertension
8. Bullae or pneumothorax, subcutaneous emphysema, mediastinal emphysema
9. extracorporeal membrane oxygenation(ECMO) has been performed when entering the ICU
10. Refractory shock
11. Severe cardiac dysfunction (New York Heart Association class III or IV, acute coronary syndrome or persistent ventricular tachyarrhythmia), right heart enlargement due to chronic cardiopulmonary disease, cardiogenic shock or heart enlargement postoperative;
12. Failure to sign informed consent
Highly Processed Foods and Vascular Health

Age is the primary risk factor for cardiovascular disease (CVD) and age-related vascular dysfunction is considered the key process linking the two. Middle age is a particularly vulnerable period when risk factors exceed diagnostic thresholds and clinical expression of CVD first becomes evident. Ultra-processed foods (UPF) comprise almost 60% of total energy in the standard American diet. The results of observational studies suggest that UPF consumption increases CVD risk, independent of overall diet quality (i.e., saturated fat, sodium, sugar, and dietary fiber intake). The "industrialized microbiota" may link diet, particularly UPF, to increased inflammation and CVD in middle-aged adults. High intake of UPF increases the likelihood of an excess heart age \>10 years and doubles the risk of subclinical coronary atherosclerosis in middle-aged adults. However, the impact of reducing UPF consumption on vascular function in middle-aged adults is unknown. The overall objective of this study is to establish proof-of-concept for an improvement in vascular function following reductions in UPF consumption in mid-life adults, in order to conduct a larger, more comprehensive and mechanistic trial in the future. In addition, changes in gut microbial composition and function, intestinal inflammation and permeability, serum endotoxin concentrations, and inflammatory cytokines as potential mechanisms by which UPF consumption influences vascular function will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Weight stable for previous 6 months (\<2 kg change)
* Sedentary to recreationally active
* No plans to gain/lose weight or change physical activity level
* Willing to pick up food daily and consume foods provided for an 8-week period
* Verbal and written informed consent
* Approval by Medical Director
* Usual UPF intake +/-15% of US average of 60% total energy
* Estrogen or testosterone usage is acceptable, if on stable dose for \>6 months
* Lipid-lowering medication usage is acceptable, if on a stable dose for \>6 months

Exclusion Criteria:

* BMI \>35 kg/m2
* Diabetes or diabetes medication
* Antibiotic, prebiotic or prebiotic use in prior 3 months
* Total Cholesterol \>6.2 mmol/L; Triglycerides \>4.5 mmol/L
* Blood pressure (BP) \> 159/99 mmHg (Stable BP on antihypertensive medications is acceptable)
* Diagnosed inflammatory bowel disease
* Past or current heart diseases, stroke, respiratory disease, endocrine or metabolic disease, or hematological-oncological disease
* Vegetarian or vegan
* Pregnant or plans to become pregnant
* Food allergies or aversions
* 3 or fewer stools per week or regular laxative use
* Lipid-lowering medication usage \<6 months
Evaluation of Add on Enstilar in Patients Using Otezla for Psoriasis

Add-on Enstilar to Otezla therapy.

50 adult patients with moderate to severe plaque psoriasis will be given OTEZLA® for 16 weeks with add-on Enstilar.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female adult ≥ 18 years of age;
2. Diagnosis of chronic plaque-type psoriasis
3. Moderate to severe plaque type psoriasis as defined at baseline by:

   * PGA score of 3 or greater
   * BSA affected by plaque-type psoriasis of 10% or greater
   * PASI ≥ 12
4. Able and willing to give written informed consent prior to performance of any study-related procedures
5. Must be in general good health (except for disease under study) as judged by the Investigator, based on medical history, physical examination, clinical laboratories, and urinalysis. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).

Exclusion Criteria:

1. Other than psoriasis, any clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is uncontrolled.
2. Forms of psoriasis other than chronic plaque-type (e.g., Pustular erythrodermic and/or guttate psoriasis) or drug induced psoriasis
3. Subjects who previously used any biologic agent for psoriasis.
4. Use of oral systemic medications for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin and cyclosporine).
5. Patient used topical therapies to treat psoriasis on the hands and/or feet within 2 weeks of the Baseline Visit (includes, but not limited to, topical corticosteroids, vitamin D analogs, or retinoids).
6. Patient received UVB phototherapy within 2 weeks of Baseline.
Effect of Metformin on Patients With Polycystic Ovary Syndrome

The purpose of the study is to understand the effect of Metformin on patients with PCOS.

This study aims to evaluate the effects of Metformin on reproductive endocrine and reproductive outcomes in women with PCOS, and to explore its underlying mechanisms to provide the intervention strategies for PCOS.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals who are 20 to 40 years old, planning to become pregnant or infertile women.
2. Individuals who are diagnosed as PCOS according to the revised 2003 Rotterdam diagnostic criteria: if 2 out of 3 criteria are met: 1) Oligo- and/or anovulation; 2) Clinical and/or biochemical signs of hyperandrogenism; 3) Polycystic ovaries, and exclusion of other aetiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome).
3. Individuals who can insist on continuous monitoring in the outpatient clinic. Individuals who are not participating in other research projects currently or 3 months before the intervention.

Exclusion Criteria:

1. Individuals who suffering from other diseases that may cause hyperandrogenism and ovulation abnormalities.
2. Individuals who are during pregnant, lactation or menopause.
3. Individuals who currently receiving weight-loss drugs or surgery or within the past 2 months.
4. Individuals who take niacin, nicotinamide, or other vitamin B3-related supplementation currently or within the past 2 months.
5. Individuals who need regular medication to treat chronic diseases such as diabetes, hypertension, gout, hyperuricemia, etc.
6. Use of medications that affect hormone levels, appetite, carbohydrate absorption, and metabolism within the past 2 months.
7. Individuals with severe liver diseases or kidney disease that are ineligible to participate in the study.
8. A medical history of severe cardiovascular and cerebrovascular diseases.
9. Individuals who currently suffer from severe gastrointestinal diseases or undergo gastrointestinal resection that may affect nutrient absorption.
10. Individuals who drink more than 15g of alcohol per day or have a smoking habit.
11. Individuals who need drug treatment for any mental illness such as epilepsy and depression.
12. Cancer patients.
13. Individuals who suffer from infectious diseases such as hepatitis B, active tuberculosis, AIDS, etc.
Discontinuation of Lens Wear in New Ortho-k Children (DOEE2)

This study aims at investigating the efficacy of myopic control using ortho-k in younger and older children.

Children wearing ortho-k have been shown to have slower rate of myopic progression than those wearing single-vision spectacles (Cho et al. 2005) or soft lenses (Walline et al. 2009). Younger myopic children (aged 6-10 years old) may have the faster increase in myopia than old myopic children (aged 11-15 years old), i.e. the rate of myopic progression may be different in different age groups and in children with different refractive status (Edwards 1999; Fan et al. 2004; Cheng et al. 2007). Although the refractive correction with ortho-k has been well documented, it is unknown whether the efficiency and reversibility of ortho-k for myopic reduction as well as myopic control are similar in children of different age and refractive groups.

In this 14-month study, the eyeball length in 45 younger (6-10 years old) and 45 older (11-15 years old) myopic children before and after ortho-k will be evaluated. Eyeball elongation will be determined for the first 7 months when single-vision glasses will be prescribed (Phase I) and the next 7 months when ortho-k will be prescribed (Phase I). Rate of myopic progression will be determined and compared between the two groups of children in the two phases.

Eligibility Criteria:
Inclusion Criteria:

* Age: between 6 to 15 years old
* Myopia: between 1.50D and 4.50D in at least one eye
* Spherical equivalent (SE): between -1.00D to -4.50D in both eyes
* Astigmatism: ≤ 3.00D of axes 180 +/- 30 or ≤ 1.00D of other axes; and the amount is less than refractive sphere
* Anisometropia: ≤ 1.50D in both refractive sphere, refractive cylinder and SE
* Best corrected monocular visual acuity: equal to or better than 0.10 in logMAR scale in both eyes
* Willingness to wear contact lenses or spectacles on a daily basis
* Can obtain good ortho-k results with the study lenses
* Availability for follow-up for at least 14 months

Exclusion Criteria:

* Strabismus at distance or near
* Contraindication for contact lens wear and ortho-k (e.g. limbus to limbus corneal cylinder and dislocated corneal apex
* Systemic or ocular conditions which may affect contact lens wear (e.g. allergy and medication)
* Systemic or ocular conditions which may affect refractive development (e.g. Down syndrome, ptosis)
* Prior experience with the use of rigid lenses (including ortho-k)
* Prior experience with myopia control treatment (e.g. refractive therapy or progressive spectacles)
* Non-compliance to the follow up schedule
* Non-compliance to the use of the prescribed optical correction
* Poor ocular response to ortho-k lens wear
* Significant residual refractive error after ortho-k treatment resulting in poor unaided vision (worse than 0.18 in logMAR scale)
Risk Factors for Severe Morbidity and Mortality in Mothers and Neonates

Improving maternal and infant mortality are key priorities in Kenya and internationally. This study aims to establish a hospital-based surveillance system for pregnant women so that the contribution of risk factors (HIV and other infections, maternal nutrition, sepsis, malaria and anaemia) to maternal and infant morbidity and mortality can be accurately assessed. All mothers who are admitted to Kilifi District Hospital will be invited to enrol in the study. Routine clinical data from maternal admissions for delivery will be systematically collected using a standardised admissions procedure. Analysis will be carried out for the risk factor effects of HIV, maternal nutrition, malaria infection, bacterial infection, and anaemia on maternal and infant outcomes after adjusting for other factors (mode of delivery, age, and parity etc). Subsequent morbidity and survival of mothers and infants, and the later consequences to children's health will be monitored through the Kilifi epi-DSS. Samples for research purposes will be collected for detailed future studies of particular pathogens and risk factors, such as malaria parasite strain, bacterial species and HIV-induced immunological impairment. This will be the first prospective study in sub-Saharan Africa (sSA) to assess the effect of these risk factors on both maternal and infant health together, and that considers both short and long term outcomes. Information generated by the study will be used by the maternity department in a rolling audit that will help improve care. The study will therefore improve care of new mothers and infants attending the Kilifi District Hospital as well as informing health planning so that future interventions for maternal and child health are targeted more effectively.


Eligibility Criteria:
Inclusion Criteria:

* All mothers admitted for delivery at Kilifi District Hospital (KDH), Kilifi, Kenya

Exclusion Criteria:

* Consent refusal
Use of Metabolomics to Differentiate the Antihypertensive Effect of Acupuncture From Sham Acupuncture in Hypertensives

To assess the effect of acupuncture versus sham acupuncture on regulating the targeted metabolome of hypertensive patients.

Acupuncture has been widely used for blood pressure management. Its effect on the cardiovascular-related targeted metabolome is still unknown. This pilot study aimed to assess the effect of acupuncture versus sham acupuncture on regulating the targeted metabolome of hypertensive patients.

Eligibility Criteria:
Inclusion Criteria:

* aged between 45 and 75 years;
* were diagnosed as stage I hypertension in the first visit, or used to be diagnosed with stage I hypertension in recent 1 year, but without any medication history;
* without neurological, other cardiovascular, hepatic and renal disease, and other visceral diseases;
* the basal metabolism rate of a patient, which was measured by the retrospective dietary questionnaire at baseline, should be approximately 1:1.4;
* didn't administer any drugs or herbs in at 15 days before the start of the study;
* didn't participate in any study other than this;
* agreed to cooperate with researchers in all research procedures after they were introduced this study; and
* provided with written informed consent.

Exclusion Criteria:

* age≤45 or age≥75;
* with hypertension which was secondary to other diseases, such as renal vascular disease, Cushing's syndrome, hyperadrenocorticism and drug-induced hypertension;
* had complicated cardiovascular, digestive, respiratory, urinary, blood, nervous, endocrine system and other severe primary diseases and failed to effectively control in clinic;
* accompanied by epilepsy, sleep apnea, hypopnea syndrome, etc.;
* with psychiatric symptoms such as severe depression or anxiety (SAS≥70, or SDS≥72);
* pregnant or lactating woman, or woman of reproductive age who was intended to conceive in recent 1 year;
* with abnormality in laboratory test of blood biochemistry, or with contagious risks, such as HIV virus carrier, or patient with positive Hepatitis B Virus (HBV) superficial antigen;
* with malignant tumor or other severe consuming diseases, or patients with infections or bleeding disorders;
* alcoholics or drug abusers, or vegetarians;
* used to suffer from acute diseases in recent 2 weeks, such as high fever, or gastritis;
* used to administer any drug that may potentially impaired renal or hepatic function;
* with cardiovascular disease that had been treated with acupuncture within recent three months; or
* undergoing other clinical trials.
Diagnostic Accuracy for Hemodynamically ICAS of MR-FFR Comparing With Pressure-wire-based FFR.

The aim of this study was to determine the diagnostic accuracy of MR-FFR to detect functionally significant ICAS comparing with pressure-wire-based FFR.

This study will perform a head-to-head comparison between MR-FFR and pressure-wire-based FFR in patients with ICAS. Pressure-wire-based FFR will be used as the gold standard for intravascular pressure gradient measurement. The efficacy and safety of non-invasive FFR will be assessed in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 years or older.
2. Patients with transient ischemic attack (TIA) or nondisabling ischemic stroke caused by a focal ICAS lesion located in intracranial anterior circulation (intracranial internal carotid artery and their major branches).
3. 50% to 99% stenosis (calculated by modified WASID method) of responsible arterial occlusion, confirmed by digital subtraction angiography (DSA).
4. Informed of the study protocol and objectives.

Exclusion Criteria:

1. Non-atherosclerotic MCA stenosis
2. Combined with moderate or severe stenosis of other extracranial and intracranial arteries
3. Previous endovascular treatment or surgery for cerebrovascular diseases
4. Large cerebral infarction (more than 1/2 MCA perfusion area)
5. Combined with other neurological diseases, such as aneurysm, arteriovenous malformation, tumor, hydrocephalus, cerebral trauma, cerebral hemorrhage, multiple sclerosis, epilepsy and intracranial infection.
6. Vascular abnormality or stunting, resulting in the impossibility of endovascular intervention
7. Liver and kidney dysfunction, or severe allergy to the contrast agent
8. Severe coagulation dysfunction
9. Pregnancy or in the preparation for pregnancy
10. Patients who cannot tolerate or do not allow MR screening, including metal implanting and claustrophobia
11. Patients with severe dementia or mental disorders, who cannot cooperate with examination
Structural and Intermediary Social Determinants of Oral Health Among Egyptian Women

Globally, there is substantial evidence indicating that low household income, lack of education, poor living conditions and inadequate psycho-social social support are potential risk factors for morbidity and premature death. Despite that, worldwide, there is scarcity in evidence on potential social determinants of oral health among different population groups.The study aims To identify the potential social determinants with an influence on oral health status of Egyptian women.

Statement of problem

Globally, there is substantial evidence indicating that low household income, lack of education, poor living conditions and inadequate psychosocial social support are potential risk factors for morbidity and premature death. Despite that, worldwide, there is scarcity in evidence on potential social determinants of oral health among different population groups.

Aim of study

To identify the potential social determinants with an influence on oral health status of Egyptian women.

Materials and methods

A total of 300 Egyptian women in childbearing age (18-49 years) will be recruited from 4 Primary healthcare units in Qalyubia governorate in Egypt. Four trained investigators will conduct a face-to face interview with study participants to gather data on potential structural and intermediary social determinants of health using a questionnaire. The questionnaire is based upon The Commission on Social Determinants of Health (CSDH) conceptual framework which was set up by the World Health Organization in 2005. This tool includes questions on socioeconomic position, material factors and living conditions, psychosocial factors and behavioral factors. Caries experience and gingival health of participants will be determined using DMFT, DMFS and CPITN indices respectively.

Eligibility Criteria:
Inclusion Criteria:

* Egyptian women in child bearing age (18-49 years) attending one of the governmental primary healthcare units.

Exclusion Criteria:

* Women who recently moved from one place of residence to another.
* Women attending the dental clinic at one of the primary health units selected for the survey.
* Pregnant Women.
* Completely Edentulous Women.
* Women with mental or psychological issues.
SPECT/CT in the Diagnosis of Dementia

Aim of the study is to evaluate whether Tc-99m-ECD-SPECT/CT enhances early diagnosis of dementia in two specific patient groups: (1) patient with mild cognitive impairment, and (2) patient with possible symptoms and signs of frontotemporal dementia. Evaluation of SPECT/CT data is performed both by visual and quantitative voxel-based analyses (Statistical Parametric Mapping). The final diagnosis is based on up to four years clinical follow-up.


Eligibility Criteria:
Inclusion Criteria (one of these):

* healthy control
* mild cognitive impairment (recruited from a population based data)
* clinically suspected frontotemporal dementia (unset diagnosis)

Exclusion Criteria:

* unable to be scanned with SPECT/CT