cyrilzakka/clinical-trials huggingface dataset:
Tamsulosin for Thyroid Lid Retraction

The purpose of this study is to examine the effect of using Tamsulosin for treatment of eyelid retraction as part of thyroid eye disease. The treatment will be offered to all thyroid patients suffering from eyelid retraction who are treated at the thyroid clinic in Sheba's Ophthalmology department. All patient will receive information about the drug Tamsulosin, the possible side effects, and the alternative treatment options for retraction.

Patients recruited will take 0.4mg/day Tamsulosin for 3 months and will have follow-ups at 1 week, 1 month and 3 months to evaluate the retraction status.

Thyroid eye disease is a common autoimmune disorder caused by antibodies directed against receptors present in the thyroid cells and extra-ocular muscles and soft tissue of the orbit. The disorder is characterised by enlargement of the extra-ocular muscles, fatty and connective tissue volume.

Upper lid retraction is the most common sign of the eye disease (present in up to 92%). The causes for retraction are not fully understood. It may be related to inflammation of the Levator muscle and the Muller muscle, or related to over sympathetic activity causing overstimulation of the Muller muscle.

Upper lid retraction severity can range from very light to severe, with scleral show, eye dryness and even exposure keratopathy. Additionally it can have a very significant effect on the patient's appearance (a constant surprised look).

Treatments for lid retraction include aggressive lubrication and tarsorrhaphy if needed (sewing the eyelids together).

The Muller is a smooth muscle which elevates the upper eyelid and is sympathetically innervated (alpha receptor).

The drug Tamsulosin which is a selective alpha1 receptor antagonist is commonly used today for benign prostatic hyperplasia (relaxing the prostate muscle).

In this study we would like to test using Tamsulosin for treatment of lid retraction caused by thyroid eye disease. We hypothesise that the relaxation of the Muller muscle may have a beneficial effect on the retraction.

Eligibility Criteria:
Inclusion Criteria:

* Thyroid eye disease patients suffering from upper eyelid retraction in one or both eyes

Exclusion Criteria:

* pregnant/breastfeeding women
* previous eyelid surgery/trauma
Clinical Characteristics and Predictors of Adverse Outcomes in HFpEF

Heart failure with preserved ejection fraction (HFpEF) is a prevalent form of heart failure characterized by impaired left ventricle pressures and diastolic dysfunction. Despite its increasing prevalence, effective treatment options for HFpEF remain limited, probably due to its heterogenous underlying pathological etiology involving chronic systemic inflammation and metabolic dysregulation. Identifying new predictors of poor prognosis is crucial for risk stratification and tailored management.

The prognosis for HFpEF is concerning, marked by significant mortality and frequent hospital readmissions. The exact mechanisms underlying HFpEF remain unresolved. The clinical syndrome arises from intricate interactions among various risk factors, leading to organ dysfunction and clinical symptoms. Common co-morbidities, including atrial fibrillation, diabetes, chronic kidney disease, and obesity, may influence HFpEF pathophysiology. Recent discussions suggest an inflammatory-metabolic phenotype in HFpEF, characterized by heightened inflammatory biomarkers, insulin resistance, hyperglycemia, hyperlipidemia, microvascular endothelial and vascular dysfunction, atherosclerosis, consequently leading to significant myocardial damage. However, there is still a lack of clinical risk predictors associated with metabolic phenotype within HFpEF.

The aim of this study is to investigate the impact of parameters reflecting the metabolic phenotype, coronary microvascular dysfunction in HFpEF and establish their correlation with clinical outcomes. The objective is to identify novel predictors for adverse prognosis in HFpEF, potentially serving as targets for drug therapy. This research aims to pave the way for targeted drug interventions in cardiometabolic diseases, offering new avenues for therapeutic approaches.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with HFpEF; Diagnostic criteria for HFpEF

  * Presence of heart failure signs/symptoms symptoms
  * Preserved left ventricular ejection fraction (EF) ≥50%
  * BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL;
  * At least one additional criteria: presence of cardiac functional and structural abnormalities or diastolic dysfunction.

Exclusion Criteria:

* LVEF lower than 50%
* Patients with serious hepatic and renal failure,
* Non-cardiac causes of dyspnea, such as, asthma
* Primary pulmonary hypertension.
* Severe valvular heart disease.
* Pericardial disease.
* Recent history of myocardial infarction.
* Coronary artery disease (stenosis\>50).
* Reduced contrast opacification (for caIMR assessment).
Registry of Thrombosis & NEoplasia of "Sociedad Española de Oncología Médica"

Epidemiological, observational, non-interventional, multicentric study on patients diagnosed with cancer who develop a venous or arterial thromboembolic episode, symptomatic or incidental, within a month prior to cancer diagnosis or at anytime after such diagnosis


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age with a histologically confirmed diagnosis of malignant tumor.
* Venous or arterial thromboembolism episode, symptomatic or incidental, in the month prior or any time after the cancer diagnosis and in the three previous months to enrollment, confirmed with an imaging technique: Doppler echocardiography, computed tomography (CT) angiography, etc.
* Signing of informed consent.

Exclusion Criteria:

* Clinical diagnosis of thromboembolic event without radiological confirmation.
* Presenting a single episode of superficial thrombophlebitis without association with another thromboembolic event.
* Each patient will be recorded just once, and therefore a second thromboembolic event will be considered a rethrombosis and will be recorded as such. Patients with a rethrombosis and a previous thromboembolic event before the start of the study in each center will not be able to be included.
A Study of the Safety and Tolerability of BMS-986183 in Patients With Liver Cancer

The purpose of this study is to evaluate the safety and tolerability of BMS-986183 in patients with liver cancer.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Must have advanced liver cancer that cannot be treated with surgery or other local methods
* Liver cancer is confirmed by a microscopic examination of tissue
* Liver disease is classified as 'A' by a standard method called Child-Pugh score
* Daily living abilities are classified as '0 or 1' by a standard method from the Eastern Cooperative Oncology Group (ECOG)
* Women must use contraception

Exclusion Criteria:

* Prior liver transplant
* Increase in blood pressure in some of the veins entering the liver
* Cancer that has spread to the brain or the layers of tissue that cover the brain or spinal cord
* Infection with both hepatitis B and C, both hepatitis D and B, infection with HIV, or other infections
* Disease of the heart or blood vessels around the heart
* Active cancers within the last 2 years
* No more than 2 prior systemic treatments or other investigational agents except PD-1/PD-L1 or Ipilimumab (Part 2)
* Currently on anti-platelet or anti-coagulation therapy
* Radiotherapy within 4 weeks of treatment
* Any major allergies

Other protocol defined inclusion/exclusion criteria could apply
Use of Fish Skin Extracellular Matrix (ECM) to Facilitate Chronic Wound Healing

The clinical study is designed to assess the effectiveness, safety and non-immunogenicity of fish skin wound dressing extracellular matrix (ECM) in treating chronic wounds.

The wound dressing is indicated for the management of difficult to heal and chronic wounds. The matrix is cut to fit the wound and is applied to the wound bed. An absorptive secondary dressing is put on top. Further dressing of the wound depends on the etiology.

The indications for use are:

* partial and full-thickness wounds
* pressure ulcers
* venous ulcers
* diabetic ulcers
* chronic vascular ulcers
* tunneled/undermined wounds
* trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)


Eligibility Criteria:
Inclusion Criteria:

* Venous leg ulcer
* Arterial leg ulcer
* Rheumatic leg ulcer
* Hydrostatic leg ulcer
* Ulcer where healing is delayed because of drug therapy
* Non-healing ulcer due to known or unknown causes

Exclusion Criteria:

* Active infection
Evaluation of the Safety and Immunogenicity of Sequential Administration of Prevnar 13™ and Pneumovax™ 23 in Healthy Participants 50 Years of Age and Older (V110-029)

The purpose of this study is to evaluate the safety and immunogenicity of sequential administration of Prevnar 13™ and Pneumovax™ 23 in healthy participants 50 years of age and older. The primary hypotheses in the study are that 1) geometric mean titers (GMTs) to pneumococcal serotypes 22F and 33F (serotypes in Pneumovax™ 23 but not in Prevnar 13™) as measured at Week 12 are superior in participants administered Prevnar 13™ on Day 1 and Pneumovax™ 23 at Week 8, as compared with participants administered Prevnar 13™ on Day 1 and placebo at Week 8 and 2) GMTs to pneumococcal serotypes shared by the two vaccines as measured at Week 12 are non-inferior in participants administered Prevnar 13™ followed by Pneumovax™ 23 as compared with participants administered Prevnar 13™ followed by placebo.


Eligibility Criteria:
Inclusion Criteria:

* Any chronic illness must be documented to be in stable condition
* Male, or a female agrees to remain abstinent, or use, or have their partner use, 2 acceptable methods of contraception through 6 weeks after receiving study vaccination; or a female who is not of reproductive potential

Exclusion Criteria:

* Is or has an immediate family member who is investigational site or sponsor staff directly involved with this trial
* Prior administration of any pneumococcal vaccine
* History of invasive pneumococcal disease
* Known hypersensitivity to any component of the pneumococcal polysaccharide vaccine, of the pneumococcal conjugate vaccine, or any diphtheria toxoid-containing vaccine
* Known or suspected impairment of immunological function, documented Human Immunodeficiency Virus (HIV) infection, asplenia, or history of autoimmune disease
* Received systemic corticosteroids (equivalent of \>=2 mg/kg total daily dose of prednisone or \>=20 mg/kg for persons weighing \>10 kg) for \>=14 consecutive days and has not completed treatment \<=30 days before study vaccination, or has received systemic corticosteroids exceeding physiological doses (\~5 mg/day prednisone equivalent) within 14 days before study vaccination (topical, ophthalmic, intra-articular, and inhaled/nebulized steroids are permitted).
* Has a coagulation disorder contraindicating intramuscular vaccination
* Receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation or autoimmune disease
* Received a blood transfusion or blood products, including immunoglobulins \<=6 months before receiving study vaccine, or is scheduled to receive them within 30 days
* Participated in another clinical study of an investigational product \<=2 months before or during the current study
* Is breast-feeding
A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft Versus Host Disease (EQUATOR)

This is a multi-center study to compare the efficacy and safety of itolizumab versus placebo as first-line therapy for subjects with Grade III-IV aGVHD or Grade II with LGI involvement, in combination with corticosteroids

This study will enroll 200 subjects at approximately 125 sites globally. Subjects will be randomized in a 1:1 ratio to active or placebo and will receive a total of 7 doses administered intravenously approximately every 2 weeks. The study follows the patients for a total of approximately 365 days.

Eligibility Criteria:
Inclusion Criteria:

1. Is willing and able to provide written informed consent/assent and to comply with all protocol procedures and assessments required for the study.
2. Is age ≥12 years and \>40kg at informed consent/assent.
3. Has had an initial allogeneic HSCT for any indication using any graft source, donor source, conditioning regimen intensity or prophylaxis.
4. Has evidence of myeloid engraftment
5. Has a clinical diagnosis of aGVHD Grades III-IV or Grade II with LGI involvement based on Mount Sinai Acute GVHD International Consortium (MAGIC) grading criteria.
6. Began systemic corticosteroid treatment for aGVHD ≤72 hours prior to the start of study drug dosing AND must receive 2 mg/kg/day methylprednisolone or equivalent on Day 1.

Exclusion Criteria:

1. Evidence of morphological relapsed, progressive, persistent, or untreated malignancy, with the exception of nonmelanoma skin cancer and in situ ductal carcinoma of the breast.
2. An unplanned donor lymphocyte infusion for persistent or recurrent malignancy after HSCT.
3. Evidence of persistent molecular disease requiring treatment that was not specified prior to HSCT.
4. Evidence of cGVHD or overlap syndrome
5. Use of immunosuppressants other than corticosteroids for the treatment of aGVHD.
6. Use of any systemic corticosteroids of \>0.5 mg/kg/day methylprednisolone or equivalent for any indication other than aGVHD within 7 days before the onset of aGVHD.
"Hyaluronan" Formulation for Dry Mouth in Sleep Apnea Patients

During routine clinical practice, it is observed that patients with suspected obstructive sleep apnea (OSA) often reported waking up with a dry mouth during the night or in the morning. This 9 week, cross-over group, randomized, single center, study will evaluate the efficacy of a proprietary formulation in comforting dry mouth in Sleep Apnea patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patient should be above 18 years of age.
2. Patients who have been initiated on CPAP therapy after an initial diagnosis of OSAS and have developed dry mouth or have worsening of pre-existing dry mouth condition, as an effect of CPAP therapy.
3. Ability to attend visits at the research site
4. Patient should be able to read and/or understand and sign the consent form and be willing to participate in the research study
5. Have a negative history of radiation therapy to head and neck
6. Agree to abstain from the use of any products for xerostomia other than those provided in the study.
7. Agree to comply with the conditions and schedule of the study.

Exclusion Criteria:

1. Subjects with open mouth sores at study entry.
2. Any pathology that, based on the judgement of the researcher, could negatively affect the oral mucosa and subsequent treatment for xerostomia (immune disorders, etc.)
3. Subjects who are nursing, becoming pregnant or plan to become pregnant during the study period
4. Subjects currently on medication or treatment for dry mouth/xerostomia
5. Subjects \< 18 years of age
6. Hypersensitivity to any of the following ingredients- HA ,xylitol and Sodium Benzoate.
7. Subjects with soft or hard tissue tumor of the oral cavity.
8. Presence of severe gingivitis
9. Chronic disease with concomitant oral manifestations other than xerostomia
10. Subjects with conditions the investigator may feel will interfere with the condition under study.
T-cell Responses to Concurrent HIV and Herpesvirus Infections

This is a research study in which we are trying to discover new information about how HIV and herpes viruses interact with the immune system. The goal of the study is to learn more about how T-cells in your immune system respond to and fight off long-term (chronic) viruses, in order to improve medical care in the future.

HIV-uninfected \& HIV-infected participants who enroll on this study will be asked to provide blood samples for 18 months. These samples will be used to assess T-cell responses and presence of herpesvirus(es).

Primary Objective

Characterize phenotypic and functional features, including TCR repertoires of HIV-specific CD8 T-cell responses and exhaustion in HIV-positive humans with and without concomitant herpesvirus infections.

Eligibility Criteria:
Inclusion Criteria:

* Criteria • Participant is greater than or equal to 18 years of age.

Group 1 (HIV Uninfected) Only

* Participant is HIV negative per antibody screen conducted on premises
* Participant is enrolled on HPTN 083 study (receiving HIV-PrEP) (see Recruitment and Screening).

Group 2 (HIV Infected) Only

* Participant has initiated ART therapy as a patient at St Jude Children's Research Hospital

  \*Note: participants will be allowed to continue on study and have data analyzed regardless of presence of detectable HIV or CD4+ counts.

  a) Newly diagnosed HIV
* Participant is HIV-1 positive per medical record documentation or positive antibody screen conducted on premises, with initial diagnosis within 90 days prior to enrollment

  b) Prolonged HIV
* Participant is HIV-1 positive per medical record documentation or positive antibody screen conducted on premises, with initial diagnosis more than 365 days prior to enrollment

Exclusion Criteria:

* Participant is unable or unwilling to provide informed consent.
* If female of child bearing potential, participant has a positive urine pregnancy test at screening. Note: if participant becomes pregnant while on study, they may not continue on study.
* Concurrent enrollment on a research study or receiving treatment for concurrent medical diagnosis with any of the following interventions which may impact study outcomes: high dose or prolonged steroids, chemotherapy to treat malignancy, radiation therapy, biologic pharmaceutical treatments that induce immunosuppression.
* If in the opinion of the investigator, participation in the blood draw would endanger the health of the participant.
* Participant is enrolled in other clinical trials that include any blood sampling such that the cumulative blood draws would exceed that established as constituting minimal risk (e.g., more than 550 ml in an 8 week period with collection more frequently than 2 times per week).
Dexmedetomidine and Propofol in Children With History of Obstructive Sleep Apnea

The purpose of this research study is to examine the effects of two commonly used anesthetic drugs, dexmedetomidine and propofol, have on the shape and muscle tone of the upper airway in children, adolescents, and young adults with a history of obstructive sleep apnea (OSA) having an MRI scan.

The results of this study will help in making the best decisions regarding the anesthesia medications that are most appropriate for children, adolescents, and young adults with OSA during MRI studies.

Patients with OSA are at risk for airway obstruction (a condition that makes it difficult to breath) during sedation and anesthesia. Dexmedetomidine and propofol are safe and effective drugs regularly used by anesthesiologists. These drugs are used to put patients to sleep for operations and certain studies like MRI scans. However, there have been no studies describing the effects these drugs have on the upper airway of children, adolescents, and young adults with OSA.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with documented history of OSA by polysomnography who require anesthesia for MRI sleep study or MRI brain imaging study.
2. Subjects must be 12 months to 25 years of age (inclusive)
3. Either the subject (if subject's age is 18-25) or the subject's legally authorized representative has given written informed consent to participate in the study

Exclusion Criteria:

1. The subject has life-threatening medical conditions (American Society of Anesthesiologists Physical Status 4, 5 or 6). The American Society of Anesthesiologists (ASA) classification scale is a measure of physical status or how healthy the patient is. For our study, we will focus on children which are defined as ASA I, II or III which means a healthy child (ASA I), a child with a systemic disease that is mild and well controlled (ASA II) or a child with systemic disease that is severe and controlled (ASA III).
2. The subject is allergic to or has a contraindication to propofol or dexmedetomidine.
3. The subject has a tracheostomy or other mechanical airway device
4. The subject is not scheduled to receive anesthesia-sedation care for the MRI
5. The subject has a history or a family (parent or sibling) history of malignant hyperthermia.
NPC-12G Gel 0.2% Sirolimus PK Bridging Study

This study is designed to describe the relative systemic bioavailability of topical and oral sirolimus formulations.


Eligibility Criteria:
Inclusion Criteria

* Male or female, non-smoker (no use within 3 months prior to screening), ≥ 18 and ≤ 65 years of age, with BMI \> 18.5 and \< 30.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females
* Females of childbearing potential who are sexually active with a male partner must be willing to use one of acceptable contraceptive method throughout the study and for 12 weeks after the last study drug administration

Exclusion Criteria

* Any sign of eczema/dermatitis, skin lesion, wound, or infection at the application site, or any other conditions that would prevent a safe application of the gel formulation.
* Laser or surgery at the gel application site within 2 weeks before the gel application.
* Positive alcohol breath test, urine drug screen or urine cotinine test at screeningation
* History of allergic reactions or hypersensitivity to sirolimus, sirolimus derivatives, or excipient of NPC-12G Gel
* Use of any drugs known to induce or inhibit CYP3A4 metabolism within 30 days prior to the first study drug administration
* Positive pregnancy test at screening
* Breast-feeding subject
* History of active tuberculosis or exposure to endemic areas within 8 weeks prior to QuantiFERON®-TB testing performed at screening
* Positive QuantiFERON®-TB test with positive chest X-ray, indicating possible tuberculosis infection
* Immunization with a live attenuated vaccine within 1 month prior to dosing or planned vaccination during the study and up to 3 weeks after the last study drug administration