cyrilzakka/clinical-trials huggingface dataset:
Transgender Estradiol Affirming Therapy

The purpose of this open label, pilot, randomized clinical trial is to evaluate the effectiveness, safety and tolerability of estrogen use in transgender female and the degree of testosterone suppression achieved in this population when placed on gender affirming pharmacological therapy.

Transgender patients suffer from poor mental and medical health outcomes compared to their cisgender peers. Given the widespread acknowledgment of the health care needs of transgender people, priority should be given to those actions that will ensure safe and appropriate care in health centers.

The current hormone therapy is not uniform and depends on the health care system, cost considerations, and differences in the regional availability of estrogens and antiandrogens. A typical regimen includes estrogen to provide feminizing effects in conjunction with therapy to block testosterone (antiandrogens or gonadotropin-releasing hormone \[GnRH\] analogs). Estrogen also inhibits testosterone secretion.

Ethinyl estradiol was previously the mainstay of most estrogen-directed therapies; this is no longer the case due to its increased risk of cardiovascular death and increased incidence of deep venous thrombosis. 17-beta estradiol, which can be provided in tablet, patch, and injection, is currently the preferred formulation.

This open label, pilot, randomized clinical trial will evaluate the effectiveness and safety of gender affirming hormone therapy with estrogen and the degree of testosterone suppression achieved in transgender female patients when placed on daily sublingual 17-beta estradiol, twice daily sublingual 17-beta estradiol, or transdermal 17-beta estradiol. All patients will also receive spironolactone as antiandrogen.

One of the major complications from estradiol GAHT is thromboembolism. The investigators will also determine the effects of the different estradiol regimens on thrombosis markers. These studies will be the first to determine if the dosing regimen of estradiol affects risk markers in transgender women.

Eligibility Criteria:
Inclusion Criteria:

* Female transgender patients between the ages of 18 to 30 years of age who are seen at the Washington University Transgender Center. Patients must have met the eligibility and readiness criteria for gender-affirming hormone therapy.

Exclusion Criteria:

* GnRH agonist for the last 12 months
* History of liver disease
* Dyslipidemia requiring treatment
* Cigarette smoking
* Body mass index \>30 kg/m2
Methylphenidate Effect on Humphrey Visual Fields

Study will include adults with abnormal visual fields. Half of them will be given either methylphenidate 10mg 2 hours before repeating the visual field test. the rest will serve as controls. All Subjects will also have a complete eye examination, a short questionnaire and a questionnaire to screen for attention deficit disorder. The investigators will compare the visual field results between the 2 tests.

Healthy adults with abnormal visual fields will be offered to participate Subjects will have a complete ophthalmic examination including dilated fundus examination.

Subjects with clear explanation for a visual field defect (e.g. optic neuropathy or retinal disorder) will be excluded from the study the subjects will be randomly assigned to the study group and control group using a 1:1 allocation.

Subjects in the study group will be provided with a single tablet of methylphenidate 10 mg to be taken orally 2 hours before repeating their visual field test.

The control group will not receive any placebo Both groups will repeat their visual fields. Both groups will fill out a short questionnaire to evaluate their experience in the second visual field test.

The study group will also fill out a screening questionnaire to rule out previously undiagnosed attention deficit disorder.

Two experienced ophthalmologists will separately interpret the visual fields results and compare the first and second visual fields of each subject, while being blinded to which group he was in.

Subjects will be provided with their test results and the ophthalmologist interpretation.

Eligibility Criteria:
Inclusion Criteria:

* abnormal visual fields
* must be able to swallow pills

Exclusion Criteria:

* psychiatric disorder
* dementia
* ocular disorder which is known to cause abnormal visual fields
* prescription of psychoactive medications
* visual acuity lower than 20/100
* cardiac arrhythmia
* hypersensitivity to methylphenidate
* prescription of warfarin
Effectiveness and Cost-utility of a Complex Intervention for Fibromyalgia Patients

Fibromyalgia (FM) is a chronic disease characterized by chronic pain, fatigue and loss of function that leads to a significant deterioration in the quality of life. Despite controversies about the most appropriate treatment, studies indicate that a multidisciplinary treatment would be effective. This study aims to analyze the effectiveness and cost-utility of a complex intervention in the quality of life (main variable), the functional impact, the mood and the pain of people with FM treated in the Primary Care Teams (PCTs) of the Catalan Institute of Health (CIH).

Methods and analysis: Mixed methodology study following the recommendations of the Medical Research Council, with two phases. Phase 1: Randomized pragmatic clinical trial with patients diagnosed with FM and assigned to one of the 11 PCTs of the CIH (Territorial management of "Terras del Ebro"). A total sample of 336 patients is estimated.

The usual clinical practice will be carried out in the control group and the usual practice and the complex treatment, in the intervention group. The complex treatment will be based on health education, aerobic physical exercise and cognitive-behavioral therapy, during 12 weeks in sessions of 2 hours/week. Statistical analysis: Assessment of the standardized mean response and of the size of the standardized effect and multivariate logistic regression analysis will be performed. The economic analysis will be based on useful measures. Phase 2: Qualitative socio-constructivist study to identify the improvement aspects of the intervention according to the results obtained and the opinions and experiences of the participants (patients and professionals). The sampling will be theoretical with 2 discussion groups composed of participants in the intervention and 2 discussion groups of professionals from different PCTs.

Eligibility Criteria:
Inclusion Criteria (all criteria must be met):

* Have a clinical diagnosis of fibromyalgia
* Have a fixed or mobile telephone
* Voluntarily accept participation in the project

Exclusion Criteria:

* Active psychotic outbreak;
* Intellectual deficiency;
* Severe depression and personality disorder;
* Self and hetero-aggressive behaviors;
* Individual assessment of active consumption of psychoactive substances;
* Incompatibility with the group's schedule.
SOLX Gold Shunt Versus Control Implant: Randomized Trial for Refractory Glaucoma

Study Objective:

To establish the substantial equivalence of the SOLX Gold Shunt to commercially available aqueous shunts, specifically the Ahmed™ Glaucoma Valve Model FP7, in the ability to reduce intraocular pressure (IOP) associated with glaucoma in eyes where medical and conventional surgical treatments have failed.

This protocol is a randomized, controlled, multi-center, outpatient study to compare the IOP lowering ability and safety profile of the SOLX Gold Shunt to the selected, commercially available aqueous shunt product (i.e., Control shunt Model FP7 Ahmed™ Glaucoma Valve Flexible Plate™) for a period of up to one year. Extended follow up is scheduled for a period not to exceed two years, should this be necessary for regulatory purposes. Follow-up beyond one year will be expected unless other patients with SOLX Gold Shunt implants in earlier phase studies outside the US clearly show no significant adverse effects associated with the long-term use of the device for follow-up periods exceeding one year, and this information is deemed adequate to reduce the required follow-up period under this protocol to a shorter period, such as 6 months for the last-to-enter patients at the time of filing for 510(k) marketing clearance review with the FDA.

Eligibility Criteria:
Inclusion Criteria:

* Primary open-angle, pseudoexfoliative, or pigmentary glaucoma
* Age 21 or over
* refractory glaucoma, with IOP \>21 mmHg on medications and failed prior incisional glaucoma surgery
* detectable visual field defect (negative MD score)
* written consent
* available for up to 24 months follow-up

Exclusion Criteria:

* either eye with VA worse than count fingers
* recent angle closure glaucoma episode
* uveitic glaucoma, iridocorneal endothelial (ICE) syndrome, traumatic glaucoma, or neovascular glaucoma
* other significant ocular disease, except cataract
* active ocular infection
* expected ocular surgery in next 12 months
* no suitable quadrant for implant
* systemic corticosteroid therapy \> 5 mg/day prednisone
* intolerance to gonioscopy or other eye exams
* mental impairment interfering with consent or compliance
* pregnancy
* known sensitivity to anticipated medications used at surgery
* significant co-morbid disease
* concurrent enrollment in another drug or device study
Impact of Nociception Level (NOL)-Guided Remifentanil Infusion on Intraoperative Arterial Pressure and Vasopressor Necessity

The aim of this study is to determine if Nociception Level (NOL)-guided Remifentanil analgesia, combined with Entropy-guided Propofol anesthesia, has a significant beneficial effect on the incidence of intraoperative hypotension episodes and/or on vasopressor requirements, during long-lasting major surgeries for high risk patients. The investigator will also investigate the effects of guided anesthesia on postoperative Myocardial Injury in Non-cardiac Surgery (MINS) and Postoperative cognitive dysfunction (POCD), amongst other frequent postoperative complications, in this population.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18
* Elective high-risk head and neck or maxillo-facial surgery

Exclusion Criteria:

* Patient refusal
* Reduced ejection fraction below 40% and heart failure
* History of atrial Fibrillation, pulmonary embolism, recent cardioversion, recent cardiac ischemic episode, chronic hypotension, chronic kidney insufficiency (serum creatinine \> 1.5)
* Septic state
* Baseline heart-rate \< 50 or \> 90 bpm
* History of psychiatric disease or medication
Validation of New Tests for Gastrointestinal (GI) Permeability

Introduction: The primary function of the gastrointestinal (GI) wall is digestion and absorption of nutrients that are important for growth and development. The second important function of the GI wall is forming an effective barrier to prevent penetration of potentially harmful components from the inside of the gut (lumen), via the GI wall, into the body.

A compromised barrier function may play an important role in the development of a range of inflammatory GI diseases such as coeliac disease, Inflammatory Bowel Disease (IBD), food allergy, but also in the pathophysiology of postoperative complications. It is important and clinically relevant to have reliable GI permeability tests, however the existing test leave room for improvement.

Rationale/aim: Three new tests are developed to assess gastrointestinal permeability in both normal controls with and without raised permeability, and in patients with coeliac disease. In the current study these new permeability tests will be evaluated and compared with the golden standard permeability test, the dual sugar test.


Eligibility Criteria:
Inclusion Criteria:

* healthy controls, female/male, 18-75 years of age, OR:
* coeliac disease without taking medicine, female/male, 18-75 years of age

Exclusion Criteria:

* cardiac and/or vascular disease
* chronic obstructive pulmonary disease (COPD)
* rheumatic arthritis (RA)
* Inflammatory bowel disease(IBD); Crohn's colitis or colitis ulcerosa
* Irritable bowel syndrome (IBS)
* Inflammatory systemic disease
* Obesity (Body Mass Index ≥ 30 kg/m²)
* Diabetes Mellitus
* Thyroid disease
* Kidney disease
* Cancer
* Smoking
* Substance abuse (alcohol, drug, cocain, opioids, and others)
* Use of drugs
* Operations to the GI system, apart from appendectomy
* Allergy to eggs or milk
* Hypersensitivity to any of the following: lactulose, l-rhamnose, sucrose, sucralose of erythritol
* Acute porphyria or phenylketonuria (PKU)
* Pregnancy
Immune Response to Third Dose of COVID-19 Vaccine in Solid Organ Transplant

The Coronavirus Disease 2019 (COVID-19) pandemic has claimed over 5 million lives globally. Fortunately, a substantial and growing number of SARS-CoV-2 vaccines with very high efficacy have been developed, manufactured, and rapidly approved. Novel mRNA vaccines such as the BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) have reported a stunning \>94% efficacy against COVID-19. However, global access has not been equitable, with many low- and middle-income countries having no vaccine access or access under emergency use mainly to traditional inactivated SARS-CoV2-2 vaccines such as BBIBP-CorV (Sinopharm Beijing), CoronaVac (Sinovac) and BBV152 (Bharat Biotech). Emerging studies have shown that lower concentrations of neutralizing antibodies (Nab) are attained after CoronaVac than after an mRNA-based vaccine in healthy individuals. This difference seems to be more pronounced in immunocompromised patients who are at higher risk of severe COVID-19 and death from COVID-19. As such, several countries including the United States, Israel and Chile have recommended a third vaccine dose for high-risk populations. However, it is not currently known which is the best vaccine combination regarding immunogenicity, particularly in these vulnerable patients.

This observational study will explore the humoral and cellular response to a SARS-CoV-2 BNT162b2 vaccine booster in solid organ transplant patients who received two previous doses of the inactivated Coronavac or two doses of BNT162b2 vaccines.


Eligibility Criteria:
Inclusion Criteria:

* Solid organ transplant patients in the last 10 years and currently under immunosuppressive therapy
* Vaccination with two doses of Coronavac vaccine or BNT162b2 vaccines, followed by a booster dose (3d dose) of BNT162b2 vaccine administered in the previous 8-12 weeks.

Exclusion Criteria:

* Previous SARS-CoV-2 infection
* Booster vaccine (3rd dose) administered less than 8 weeks or more than 12 weeks before enrolment
* Intravenous immunoglobulin therapy 60 days before enrolment
* Previous SARS-CoV-2 vaccine different from CoronaVac or BNT162b2
Evaluation of the Efficacy of Rosuvastatin in Daily Practice in Untreated High Risk Patients (CHALLENGE)

In an observational multi-centre study (CHALLENGE), the effects were assessed of starting treatment with low doses of rosuvastatin in statin naive patients with a history of coronary heart disease (CHD), peripheral vascular disease (PVD), cerebrovascular accident (CVA), transient ischemic attack (TIA) or diabetes (DM), on low-density lipoprotein cholesterol (LDL-C) goal achievement. Also proportional changes in LDL-C, high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), triglycerides (TG) and the ratio TC/HDL-C were studied.


Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for the study were high-risk patients with a documented history of CHD, PVD, cerebrovascular atherosclerotic disease, DM II or DM I with microalbuminuria. LDL-C had to be \> 2.5 mmol/l and the patient did not use any cholesterol lowering medication during the last 3 months preceding inclusion. The specialist made the decision to start treatment with rosuvastatin irrespective of study participation. Patient approved to place anonymous results at the disposal of AstraZeneca

Exclusion Criteria:

* Exclusion criteria included patients familiar with muscular pain, myopathy or liver function disorders (inclusive elevation of serum transaminases), patients with familial dyslipideamia like familial hypercholesterolaemia and familial combined hyperlipid
Dual-focus Soft Contact Lenses for Controlling Rapid Progressive Myopia in Young Adults

This study aims to evaluate the effectiveness and acceptability of dual-focus soft contact lenses in controlling rapid myopia progression in adults through a randomized controlled trial. By applying myopia control measures to the adult population, we hope to provide scientific evidence for the effective control of adult myopia progression and offer insights into the understanding of myopia progression during early adulthood.

It has long been believed that the progression of myopia mainly occurs during the elementary to high school stages. However, some studies and clinical practice suggest that a considerable proportion of adults still experience myopia progression in their adulthood, especially in those who have prolonged near work or screen usage time. At present, there is insufficient evidence on whether these population needs myopia control intervention. Most adults experiencing myopia progression do not receive appropriate myopic intervention measures, leading to an increase of dioptre, which may affect the quality of daily life, and raise the risk of high myopia and blinding myopia complications.

This study aims to evaluate the effectiveness and acceptability of dual-focus soft contact lenses in controlling rapid myopia progression in adults through a randomized controlled trial. By applying myopia control measures to the adult population, we hope to provide scientific evidence for the effective control of adult myopia progression and offer insights into the understanding of myopia progression during early adulthood.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-25 years;
* Myopia progression \<= -0.50D in either eye in the past year (evaluated by -manifest refraction);
* The subject eye: cycloplegic spherical equivalent ranges from -2.00D to -6.0D and cylinder power doesn't exceed -1.50D;
* The subject eye's best corrected visual acuity \<= logMAR 0.1;
* Anisometropia does not exceed 1.50D.

Exclusion Criteria:

* Current use of MC interventions or prior use of MC interventions within the past 6 months;
* Disease or anatomical factors that affect the wearing of contact lenses;
* History of myopia correction surgery;
* Suffering from ocular or systemic diseases that may be related to myopia, such as Marfan syndrome, retinopathy of prematurity, diabetes, etc.;
* pregnant female;
* Other conditions deemed unsuitable by the investigators.
Strengths and Weaknesses of Physiotherapy in the Daily Work of an Intensive Care Unit

Background. A stay in the Intensive Care Unit can cause long-term problems and physiological changes at the neuromuscular and respiratory levels in critically ill patients. Early physiotherapy in these patients is safe and feasible to avoid or reduce the adverse musculoskeletal and respiratory effects of the stay in this hospital unit.

Objective. To identify the strengths and barriers of Physiotherapy in an Intensive Care Unit, according to the vision of different Health Science professionals.

Method. Qualitative observational study using individual interviews and focus groups. 18 people (6 doctors, 6 nurses and 6 physiotherapists) will be included in the study. The 18 health professionals will participate in personal interviews and focus groups (3 focus groups with 6 participants each). Participants will be recruited from the Intensive Care Unit of the Hospital Universitario Central de Asturias. Data will be analysed using the thematic analysis approach according to Braun and Clarke's method. We will use face-to-face interviews and focus groups to collect data and analyse them through thematic analysis. Purposive sampling will be used to recruit our participants. We will continue to recruit participants, if necessary, until saturation of data from the thematic analysis is reached.

Expected outcomes. To assess the knowledge, perceptions and expectations of the healthcare staff in the Intensive Care Unit regarding Physiotherapy in the management of patients admitted to this Unit. To identify the strengths of Physiotherapy in the management of these patients.


Eligibility Criteria:
Inclusion Criteria:

* Professionals from the Intensive Care Unit of the Hospital Universitario Central de Asturias.
* With clinical experience of at least 2 years.
* Currently working or having worked in coordination with physiotherapists in the Intensive Care Unit.

Exclusion Criteria:

* Professionals who are unfamiliar with the usual physiotherapy therapy in an Intensive Care Unit.
* Resident interns in their first year of training.
Effect of Helicobacter Pylori Treatment on Idiopathic Central Serous Chorioretinopathy (ICSCR)

Etiology of ICSCR is not known however recent studies regard the role of immunologic and infectious processes in the pathogenesis of ICSCR.one of these hypothesis is the role of helicobacter pylori in the pathogenesis of ICSCR so perhaps treatment of h pylori have positive effect on the remission of ICSCR.

we will choose 50 cases of patients with ICSCR who are infected with h.pylori.25 cases will receive anti h.pylori regiment and 25 cases as controls will receive no medication.then we will compare the time of submacular fluid resorption and macular thickness and visual acuity among these two groups.

Eligibility Criteria:
Inclusion Criteria:

* the persons who are infected with helicobacter pylori and have ICSCR

Exclusion Criteria:

* history of previous eye surgery ,to have indication of laser therapy,corticosteroid therapy,pregnancy,