cyrilzakka/clinical-trials huggingface dataset:
Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell Arteritis

The factors underlying the large interindividual variability in response to glucocorticoids in Giant Cell Arteritis are poorly understood. The investigators hypothesize that a part of this variability is related to pharmacokinetic factors determined by genetic polymorphism: hepatic clearance involving cytochromes P450 of the subfamily 3A (CYP3A) and drug efflux leukocyte conditioned by P-glycoprotein involved in multidrug resistance drugs (ABCB1). The investigators have designed a multicentric prospective pharmacokinetical and pharmacogenetic cohort study to assess the link between prednisolone clearance and the relapse risk in giant cell arteritis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of GCA, meeting at least 3 of the following 5 American College of Rheumatology (ACR) criteria for the diagnosis of GCA:

  1. At least 50 years of age at disease onset
  2. New onset or new type of localized pain in the head
  3. Temporal artery abnormality (i.e., temporal artery tenderness to palpation or decreased pulsation unrelated to arteriosclerosis of cervical arteries)
  4. ESR of greater than 40 mm in the first hour by the Westergren method
  5. Temporal artery biopsy showing vasculitis characterized by a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cells
* Corticoid treatment since less than 14 days
* Signed informed consent
* Affiliation to the social security system

Exclusion Criteria:

* Dementia
* Predictable non observance
* Neoplasia since less than 5 years
Theobromine from Cocoa and Cardiovascular Risk Factors

The goal of this clinical trial is to examine whether consumption of dark chocolate affects blood pressure and a cardiovascular risk factor called trimethylamine N-oxide in Thai male participants with hypertension. The main questions it aims to answer are:

Can consumption of dark chocolate lower blood pressure? Can consumption of dark chocolate lower blood trimethylamine N-oxide?

Researchers will compare dark chocolate to white chocolate to see if the effects are due to theobromine (a key bioactive compound in dark chocolate).

Participants will consume either 100 g 72% dark chocolate bar or 80 g white chocolate bar daily for 14 days, rest for 7 days, and then switch to the other type of chocolate.

This is a randomized cross-over trial conducted in Chiang Mai, Thailand. The goal of this clinical trial is to examine whether consumption of dark chocolate affects cardiovascular risk factors, with the primary outcomes being blood pressure and a cardiovascular risk factor called trimethylamine N-oxide. Participants are Thai males aged 35-70 years with hypertension who live in the Chiang Mai area.

42 Participants will consume either 100 g 72% dark chocolate bar (\~2.5 servings, providing \~900 mg theobromine) or 80 g white chocolate bar (\~2 servings, providing 0 mg theobromine) daily for 14 days. After a 7-day wash-out period, the participant will repeat the protocol with the other intervention.

Eligibility Criteria:
Inclusion criteria

* Male
* Age between 35 to 70 years
* BMI less than 30 kg/m\^2
* Systolic blood pressure between 130 to 159 mmHg or Diastolic blood pressure between 85 to 99 mmHg.
* Do not smoke.

Exclusion criteria

* Cannot drink beverages and consume foods that have caffeine.
* Take medicine to lower cholesterol and triglyceride levels, treat high blood pressure, or diabetes.
* Have liver and kidney inflammation.
* Use antibiotics within 1 month of study.
* Use choline or probiotic supplements regularly within 1 month of study.
* Consume more than 30 alcoholic drinks per week.
* Have chronic diseases.
Effect of Nebivolol on Oxidative Stress and Endothelial Progenitor Cells

Hypertension, or high blood pressure, is a common disease that affects many Americans, and can lead to devastating consequences such as heart attack, stroke, and death if not treated. Nebivolol is a medication that has been recently approved by the FDA for the treatment of hypertension. Nebivolol has an unusual profile compared to other medications, in that its effects may be related to release of a substance called nitric oxide. Nitric oxide is released from the cells lining the blood vessels, and nebivolol may stimulate these cells to release more nitric oxide. Our study will investigate whether treatment with nebivolol, as compared to another medication called metoprolol, in hypertensive subjects will be more effective in protecting blood vessels against the harmful effects of high blood pressure. The mechanisms we will investigate include oxidative stress markers and circulating levels of endothelial progenitor cells.


Eligibility Criteria:
Inclusion Criteria:

1. Males or post-menopausal females aged 21-80 years.
2. Hypertensive patients (BP \>135/85) will be eligible to participate.
3. Patients on current anti-hypertensive therapy that does not include beta blockade should have BP \>135/85.
4. Patients on anti-hypertensive therapy including beta blockade will have their beta blockers discontinued gradually over 2 weeks before enrolment.
5. Concomitant therapy: Patients will be allowed to be on comcomitant therapy with aspirin, statins, thiazide diuretics, calcium antagonists (for treatment of hypertension), clonidine, vasodilators, or angiotensin antagonists. Patients will be on stable medical therapy for at least 2 months before recruitment. Patients with previous treatment with beta adrenergic blockers (metoprolol, propranolol, atenolol, and labetalol) will also be eligible to participate, but will be randomized to the study beta blocker.

Exclusion Criteria:

1. Age \< 21 or \>80 years
2. Initiation or change in dose of statin or anti-hypertensive therapy within 2 months before the study
3. Premenopausal females with potential for pregnancy
4. Acute infection in previous 2 weeks
5. History of substance abuse
6. Current neoplasm
7. Chronic renal failure \[creatinine \> 2.5 mg/dL\] or liver failure (Liver enzymes \>2X normal)
8. Acute coronary syndrome, Class IV heart failure, CVA, coronary intervention within 2 months
9. Known aortic stenosis, hypertrophic cardiomyopathy.
10. Inability to give informed consent
11. Inability to return to Emory for follow-up testing
Sexual Health and Sexual Myths During Pregnancy

The aim of this experimental study is to learn the effects of sexual health education during pregnancy on sexual myths, sexual function and quality of sexual life. The main question it aims to answer is:

Is sexual health education effective in correcting sexual myths? Is sexual health education intervention effective in improving quality of sexual life? Is sexual health education intervention effective in improving sexual function? Participants who received the educational intervention prepared to improve quality of sexual life, sexual myths and sexual function will answer the survey questions after the completion of the training program.

Pregnancy, birth and the postpartum period are important processes in which expectant mothers and fathers experience many physiological, psychological and social changes. Pregnancy is also one of the periods when sexuality is most affected and sexual dysfunctions are commonly seen during this period. Despite the age of information and technology, sexual inexperience or lack of knowledge, growing up in a conservative society, deficiencies in sexual education and false beliefs and myths about sexuality are among the common causes of sexual dysfunction in women. These factors affect couples' attitudes and behaviors regarding sexuality during a sensitive period such as pregnancy, causing couples to experience negativities in their sexual lives.

Sexual dysfunction in women is a complex problem affected by many biological, psychological and individual factors. It is stated that sexual dysfunction in women is a common problem that increases with age and affects 30% to 50% of women, but it is known that its prevalence is quite high among young women.

Sexual life quality can be defined as the individual's perception of their own sexual life in a culture and value system according to their personal goals, expectations, criteria and earnings. Almost all sexual myths consist of negative attitudes such as sexual intercourse during pregnancy being harmful, and these attitudes also negatively affect the quality of sexual life.

By receiving consultancy services on how to have sexual life during pregnancy and obtaining information from the right sources, the prevalence of sexual myths during pregnancy will decrease and the effect on the quality of sexual life during pregnancy will be minimized.

This study aims to provide training to the target group of pregnant women on issues such as reproductive health, changes that may occur due to pregnancy, sexual activity during pregnancy and the postpartum period, and hygiene. The aim of these trainings is to inform pregnant women about sexual health and to increase the quality of their sexual life.

Eligibility Criteria:
Inclusion Criteria:

* At least primary school graduate
* Being in the 18-49 age group
* Being pregnant

Exclusion Criteria:

* Having a condition that prevents communication
* Receiving hospital treatment during the data collection process
Analysis of Cataract Surgery Induced Dry Eye

This is a retrospective study to determine if rates of osmolarity and dry eye disease symptoms increase following cataract surgery.

The objective of this study is to determine if tear osmolarity is a good predictor for dry eye following cataract surgery.

The practice will retrospectively identify patients that have had cataract surgery from billing records. This will be cross referenced with patients that have had the diagnosis of dry eye and have had tear osmolarity testing, also from billing or electronic records analysis. The studies will be done at sites that have inclusion of a general statement about record review for research in the patient intake information at the practice. Information will be taken from the baseline visit at the final pre-operative examination prior to cataract surgery from these patients who have had tear osmolarity measured on each eye using the TearLab osmolarity device.

Because this is a retrospective study, patients will have followed each surgeon's typical pre-operative and post-operative protocol (i.e., lid cleansing, topical antibiotics, steroids, NSAIDS, etc.) without other peri-surgical complications, and followed at the normal post-operative follow-up appointments. Whenever tear osmolarity measurements had been taken and recorded in the patient's chart, this information will be collected from the patient's chart and recorded in a database. Information from visits up to and including the 3 month postoperative interval will be recorded. Additional information recorded will be demographic information such as age, corrected vision before and after the cataract surgery at the one month visit as well as at any time that tear osmolarity is measured. Additionally, any comments made in the history of present illness statement regarding dryness will be recorded in the database. Presence of other ocular surface disease present such as blepharitis, allergic disease, or anterior basement membrane dystrophy will be recorded. Systemic medications that the patient is taking will also be recorded. Presence or absence of diabetes mellitus will also be recorded. The database will be kept in a password protected computer in a locked office location, and every precaution will be taken to prevent identification of any patient specific identifiers. Information will be de-identified as soon as possible by using codes to identify the data rather than patient names or chart numbers.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, eighteen years of age or older
2. Confirmed diagnosis of cataract with cataract surgery performed in at least one eye

Exclusion Criteria:

1. Any complications of cataract surgery that have required a sclera incision rather than a clear corneal incision.
Safety and Performance of Miami InnFocus Drainage Implant (MIDI Arrow) Glaucoma Drainage Implant

To assess the safety and performance of the MIDI Arrow in patients suffering from glaucoma that is inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 40 mm Hg

This will be a monocentric, non-randomized, single arm clinical study in which each patient meeting the inclusion criteria and not excluded per the exclusion criteria will be implanted with a MIDI Arrow in the anterior chamber of the eye. Patients will be followed for at least 24 months with an expected enrollment period of up to 24 months. Safety of the shunt will be evaluated with indirect and direct microscopic evaluation of the implanted and non-implanted eyes pre and post operatively, and at defined follow-up intervals for hypotony, inflammation, infection, migration of the shunt, visual acuity, as well as a number of other defined potential complications. The effectiveness of the shunt will be evaluated by measurement of intraocular pressure at defined intervals.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patient, age 18 to 85 years, inclusive
2. Patient has primary open angle glaucoma that is inadequately controlled on tolerated medical therapy with intraocular pressure greater than or equal to 18 mm Hg and less than or equal to 40 mm Hg
3. Patient must have signed and dated the Informed Consent form

Exclusion Criteria:

1. Unwilling or unable to give informed consent or unable to return for scheduled protocol visits.
2. Pregnant or nursing women.
3. No light perception.
4. Active iris neovascularization or active proliferative retinopathy.
5. Iridocorneal endothelial syndrome.
6. Epithelial or fibrous downgrowth.
7. Pseudoexfoliative glaucoma
8. Aphakia.
9. Vitreous in anterior chamber for which a vitrectomy is anticipated.
10. Corneal disease
11. Acute, chronic or recurrent uveitis.
12. Severe posterior blepharitis.
13. Unwilling to discontinue contact lens use after surgery.
14. Previous ophthalmic surgery, excluding phacoemulsification (cataract) surgery or corneal refractive surgery.
15. Prior cataract surgery involving a conjunctival incision
16. Need for glaucoma surgery combined with other ocular procedures except for cataract surgery or anticipated need for additional ocular surgery during the investigational period.
17. Less than 0.1 (20/200) visual acuity in the non-test eye.
18. Infectious conjunctivitis, a narrow-angle glaucoma, endophthalmitis, orbital cellulitis one, infection, severe dry eye, severe myopia, conjunctivitis fine.
Blood Flow, Muscle Regeneration and Sarcopenia

Due to the rapid aging of the population, sarcopenia is among the greatest challenges facing the health care system over the next quarter century. This age-related loss of skeletal muscle mass and strength directly contributes to the incidence of functional disability, thereby reducing independence and quality of life for the elderly. Despite increasing efforts to combat sarcopenia, its etiology remains incompletely described. Subsequently, limited progress has been made in developing comprehensive preventative and therapeutic strategies to combat the problem. A decreased ability to regenerate skeletal muscle fibers through the donation of skeletal muscle stem cells (satellite cells) is thought to contribute to sarcopenia. However, the upstream physiological mediators that regulate this impairment are poorly delineated.

Reduced muscle blood flow in advanced age appears to be a significant factor in reducing skeletal muscle regenerative capacity, but few data exist to confirm this hypothesis. Thus to test this hypothesis we aim to conduct a translational pilot trial which examines regeneration in both young and old adults. Furthermore, we aim to determine if muscle blood flow and satellite cell number are associated with muscle function. The central hypothesis of this proposal is that age-related declines in skeletal muscle angiogenesis and perfusion are significant causal factors in age-related losses of skeletal muscle mass. The specific aims and hypotheses of the project are as follows:


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18-30 years
* Men and women aged \> 70 years
* Body mass index \< 35
* Willing and able to participate in all aspects of the study
* Sedentary to moderately active lifestyle \<120 min physical activity/week \< 30 min moderate aerobic exercise/week \< 30 min resistance training/week OR Participates in regular structured exercise \> 120 min/week
* Non-smoking

Exclusion Criteria:

* Active treatment for cancer, stroke (\< 6 mo), peripheral vascular disease, coronary artery disease (myocardial infarction \<6 mo), state III, IV Congestive Heart Failure, valvular heart disease, major psychiatric disease, severe anemia, liver or renal disease, diabetes, severe osteoarthritis, blindness or deafness, fracture in upper or lower extremity within the last 6 months, upper or lower extremity amputation, anticoagulant therapy (aspirin use is permitted), parkinsons disease
* Failure to give consent
* Anabolic medications (growth hormone or testosterone)
* High amounts of physical activity (i.e. running, bicycling etc \> 120 min/week).
* Dementing illness
* Smoking
* Pregnant
* Significant cognitive impairment; Mini-Mental State (MMSE) exam \< 24
* Statin Usage
* Excessive alcohol use (\>2 drinks per day)
* Resting heart rate \> 120 bpm
* Systolic blood pressure \> 180 mmHg
* Diastolic blood pressure \> 110 mmHg
* History of significant head injury
* Anticholinesterase inhibitor (such as Aricept)
* Contraindications to MRI (e.g. cardiac pacemaker, implanted cardiac defibrillator, aneurysm clip, claustrophobia, etc.)
* Current Use of Antidepressant Medications
Incidence and Risk Factors of Parastomal Hernia in Patients With Permanent Colostomy in China

Parastomal hernia refers to the protrusion of the area around the stoma or the ectopic protrusion of abdominal contents from the stoma (colostomy, ileostomy, ileostomy for bladder) in the abdominal wall defect. Parastomal hernia is one of the common complications after permanent colostomy. According to guidelines published by the European Hernia Society, the overall incidence of parastomal hernia is unknown, but it can be predicted to be over 30% at 12 months, over 40% at 2 years, and over 50% at longer follow-up periods. Parastomal hernia may have no obvious symptoms at the beginning or only protrusion around the stoma. However, with the progression of the disease, the protrusion site may gradually increase, resulting in leakage, skin ulcers, perforation, incarceration, obstruction, strangulation and other serious complications. It will seriously affect the quality of life of patients and increase the medical burden and cost.

Risk factors related to parastomal hernia are currently considered to be mainly related to the patient's own factors and surgical factors. Studies have shown that female, old age, obesity, cardiopulmonary diseases, diabetes, long-term use of cortisol and other factors can increase the incidence of parastomal hernia in patients . Methods of stoma including extraperitoneal stoma, appropriate aperture of stoma and preventive mesh placement can reduce the incidence of parastomal hernia in patients.

In this study, patients with permanent colostomy and relevant information of surgery as well as the current incidence of parastomal hernia will be retrospectively collected in some high-level and high-volume tertiary hospitals in China. This study will be helpful to provide data reference for subsequent studies in this field.


Eligibility Criteria:
Inclusion Criteria:

* permanent colostomy after colorectal surgery for benign or malignant diseases
* No previous colostomy history

Exclusion Criteria:

* No CT scan follow-up at 1 year after surgery
* Another ileocolonic diversion was performed except for the cause of parastomal hernia
House Dust Mite SLIT in Elderly Patients

The safety and efficacy of specific sublingual immunotherapy for house dust mite allergens in patients over 60 years of age with allergic rhinitis and a confirmed allergy to house dust mites were the focus of the stu First, 111 patients, ages 60-75 years, with allergic rhinitis and with a confirmed allergy to D. pteronyssinus and D. farinae by the use of skin prick tests, serum-specific IgE and nasal provocation tests were included. Patients were individually randomised to groups: active or placebo using a double-blind method. A total of 51 subjects in the sublingual allergen-specific immunotherapy (SLIT) group (Staloral 300R, Stallergens, France) and 57 in the placebo group were monitored for three years. The patients had to record on a diary card whenever they used anti-allergic medications.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with allergic rhinitis who fulfilled the ARIA criterion and had a positive skin prick test (SPT), were positive for specific immunoglobulin E (sIgE) and had positive nasal provocation tests (NPTs) by Dermatophagoides pteronyssinus (Der p) and Dermatophagoides farinae (Der f) were included in the study

Exclusion Criteria:

* Patients with any of the following characteristics were excluded:

  * hypersensitivity to other allergens,
  * non-allergic rhinitis (especially senile or vasomotor rhinitis) or
  * severe non-stable diseases (especially bronchial asthma). However, stable coronary disease, diabetes, arterial hypertension and well-controlled, mild or atopic bronchial asthma were permitted.
Neoadjuvant Sintilimab Plus Chemoradiotherapy for Locally Advanced Adenocarcinoma of Esophagogastric Junction

The purpose of this study is to access the safety and efficacy of neoadjuvant Immunotherapy (Sintilimab, PD-1 inhibitor) combined with chemotherapy (S-1+Oxaliplatin) and radiotherapy for locally advanced esophagogastric junction adenocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70, male and female.
* Histologically confirmed locally advanced esophagogastric junction Adenocarcinoma cT3-4aNxM0 (AJCC v8), Siewert typed as type II-III.
* No previous anti-tumor treatment.
* ECOG score was 0-1.
* Expected survival of ≥ 6 months
* Adequate organ reserve function.

Exclusion Criteria:

* Malignant disease other than gastric cancer (excluding radically treated basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or radically resected carcinoma in situ) diagnosed within 5 years.
* Known Her-2 positive( IHC 3+ or FISH positve).
* Patients have received immunotherapy, such as PD-1 antibody, PD-L1 antibody and CTLA4 antibody
* Severe allergic reaction to monoclonal antibody.
* Receiving systemic glucocorticoid therapy within 7 days prior to the first dose of the study
* Known endoscopic signs of active bleeding from the lesion