cyrilzakka/clinical-trials huggingface dataset:
A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer

The reason for this study is to see if the study drug LY3484356 alone or in combination with other anticancer therapies is safe and effective in participants with advanced or metastatic breast cancer or endometrial cancer.


Eligibility Criteria:
Inclusion Criteria:

All study parts:

* Participants must be willing to provide adequate archival tissue sample
* Participants must be willing to use highly effective birth control
* Participants must have adequate organ function
* Participants must be able to swallow capsules

Dose escalation- Participants must have one of the following:

* Parts A and B: ER+ HER2- breast cancer with evidence of locally advanced unresectable or metastatic disease who have had the following:
* Part A: may have had up to 1 prior regimen of any kind for in the advanced/metastatic setting and no prior cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy.
* Part B: may have had up to 2 prior regimens, no more than 1 of which may be endocrine therapy in the advanced/metastatic setting, and must have received a prior CDK4/6 inhibitor
* Cohort E4: No prior everolimus.
* Cohort E5: No prior alpelisib and must have a phosphatidylinositol 3-kinase catalytic α (PIK3Cα) mutation as determined by local testing.
* Part C: ER+, human epidermal growth factor receptor 2 positive (HER2+) breast cancer with evidence of locally advanced unresectable or metastatic disease who have had at least 2 HER2-directed therapies in any setting.
* Part D: ER+, EEC that has progressed after platinum containing chemotherapy and no prior fulvestrant or aromatase inhibitor therapy.
* Part E: ER+ and HER2+ breast cancer with evidence of locally advanced, unresectable, or metastatic disease.
* Part E: Participants must have received induction taxane chemotherapy combined with trastuzumab + pertuzumab as first-line treatment for advanced/metastatic disease and must not have progressed on this regimen.
* Part E: Participants must not have received more than 1 HER2-directed regimen or any endocrine therapy for advanced disease or any prior CDK4/6 inhibitor therapy.

Participants with ER+/HER2- breast cancer enrolled in this study must have had evidence of clinical benefit while on endocrine therapy for at least 24 months in the adjuvant setting or at least 6 months in the advanced/metastatic setting or have untreated de novo metastatic breast cancer

Exclusion Criteria:

* Participants must not have certain infections such as hepatitis or tuberculosis or HIV that are not well controlled
* Participants must not have another serious medical condition
* Participants must not have cancer of the central nervous system that is unstable
* Participants must not be pregnant or breastfeeding
Inspiratory Muscle Endurance of Adults

The aim of this study is to determine the reference value ranges for healthy adults of the incremental threshold load test, which evaluates respiratory muscle endurance.

Since respiratory muscles are used in daily life at the submaximal level, evaluation of their endurance is more meaningful functionally. In addition, evaluation of endurance with respiratory muscle strength is effective in determining respiratory muscle dysfunction. Failure to routinely evaluate respiratory muscle endurance, which is one of the main components of respiratory muscle function, may lead to failure to identify respiratory muscle dysfunction in early stage respiratory patients who have not yet developed muscle strength loss. However, normal value ranges have not been determined for the respiratory muscle endurance test.

Determining the normal value ranges for this test will help determine muscle fatigue and investigate the physiological course in respiratory diseases.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-35
* Not having any disease
* Not exercising regularly
* Not smoking

Exclusion Criteria:

* Having a respiratory disease
* Have heart disease
* Have a neuromuscular disease
* Have Scoliosis
* Having had thoracic surgery
* Having experienced the respiratory muscle endurance protocol before
Anticoagulation for Aortic Bioprosthesis (ANTIPRO)

This study evaluates the clinical and hemodynamic outcome in patients after aortic valve replacement. Half of the patients will receive warfarin + aspirin and the other half will receive only aspirin. The investigators will focus mainly on early bioprosthesis degeneration.

Aortic bioprosthesis have the advantage that they do not require life-long anticoagulation. Current guidelines support the use of aspirin (AAS) 100 mg as a class I indication.

Current evidence, mainly derived from transaortic valve implantation (TAVI) patients, have shown that aortic bioprosthesis suffer subclinical thrombosis which may explain the increase in gradient and bioprosthetic degeneration. Anticoagulation in this cases improve leaflet mobility and decrease in gradient. Evidence supporting early anticoagulation in patients with aortic bioprosthesis is not as strong as in the case of mitral bioprosthesis. Nonetheless, current American Heart Association/American College of Cardiology (AHA/ACC) guidelines recommend (IIa) the use of warfarin for at least 3 months after aortic valve replacement.

The aim is to conduct a single blinded (echocardiographist) randomized control study in patients who receive an aortic bioprosthesis. Comparison will be performed between the use of warfarin + aspirin vs aspirin alone. Duration of anticoagulation will be for 3 months and patients follow-up for 1 year. Clinical and echocardiographic evaluation will be performed in every patients. Some patients will undergo Positron Emission Tomography (PET-Scan).

Eligibility Criteria:
Inclusion Criteria:

* Patients with indication of aortic valve replacement with porcine bioprosthesis

Exclusion Criteria:

* Concomitant mitral valve replacement
* Previous atrial fibrillation
* Previous use oral anticoagulation
* Contraindication for the use of oral anticoagulation (high risk of bleeding, intolerance, allergy)
* Jehovah witness
* Platelet count below 90,000.
* Liver disease
Impact Of Timing Of Drainage Of Massive Ascites On Operative And Post-Operative Course In Living-Donor Liver Transplant Recipients. A Prospective Randomized Controlled Trial.

Massive ascites is usually controlled over several weeks pre-operatively in liver transplant recipients with the risk of encephalopathy and peritonitis. We hypothesized that intra-operative drainage of ascites will be safe and avoids the inherent risks of pre-operative drainage.


Eligibility Criteria:
Inclusion Criteria:

* liver transplant candidates with tense acsites

Exclusion Criteria:

* severe coagulpathy (INR more than 2 or platlet count less than 50) MELD more than 20
Pilot Study of a Suprachoroidal Retinal Prosthesis

This study will be an initial proof of concept study, to evaluate safety and efficacy of a prototype suprachoroidal retinal implant


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Either gender
* A confirmed history of outer retinal degenerative disease such as retinitis pigmentosa or choroideremia
* Remaining visual acuity of bare light perception or less in both eyes
* Functional inner retina (ganglion cells and optic nerve), as shown by the ability to perceive light and/or a measurable corneal electrically evoked visual response
* A history of at least 10 years of useful form vision in the worse seeing eye
* Must be willing and able to comply with the testing and follow-up protocol demands (preferably residing within 1.5 hours of the investigational site)

Exclusion Criteria:

* Optic nerve disease (history of glaucoma of more than 1 month, or history of any other optic neuropathy)
* Diseases of the inner retina including, but not limited to, central retinal artery or vein occlusion (CRAO, CRVO), end stage diabetic retinopathy, retinal detachment, traumatic retinal damage, infectious retinal disease, inflammatory retinal disease.
* Inability to visualise the retina due to corneal or other ocular media opacities (corneal degenerations, dense cataracts, trauma, lid malpositions)
* Any ocular condition that predisposes the subject to rubbing their eyes
* Cognitive deficiencies, including dementia or progressive neurological disease
* Psychiatric disorders, including depression, as diagnosed by a qualified psychologist
* Deafness or significant hearing loss
* Inability to speak or understand English
* Pregnancy
* Presence of a cochlear implant
* Subject enrolled in another investigational drug or device trial for the treatment of their ocular condition
* Poor general health, which would exclude them from obtaining a general anaesthetic
* Unrealistic expectations of the bionic eye device
Inflammation Following Mepolizumab and Oral Corticosteroids in Asthma

The aim of the project is to study the persistence of inflammation after addition of an interleukin-5 (IL-5) blocker in severe eosinophilic asthma as a study of untreated pathways in these patients.

Mepolizumab, a humanized monoclonal antibody (mAb) antagonizes IL-5 and through a selective inhibition of eosinophilic inflammation, reduces the number of eosinophils in sputum and blood, leading to a reduction in asthma exacerbations and a need for systemic glucocorticoids. Once this therapy has been initiated for severe eosinophilic asthma, the additional role of oral corticosteroids is questionable as their main target is reduction of eosinophils and hence responsiveness to oral corticosteroids in patients in a stable state of asthma may reduce.

Using two weeks of high dose prednisolone versus placebo in a crossover design after 12 weeks of mepolizumab therapy will allow an understanding of the pathways that remain steroid responsive following IL-5 suppression.

This is an exploratory study with no single primary end point. The objective of the study is to assess the change in airway inflammation following oral corticosteroids versus placebo and the airway inflammation while on mepolizumab in stable state of asthma.

Note: Mepolizumab is not an intervention in this study; it is initiated as part of usual NHS care.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and ≤ 80 years at consent.
* Able and willing to provide written informed consent and to comply with the study protocol.
* Severe asthma diagnosis confirmed after assessment by an asthma specialist.
* Suitable for mepolizumab as per NICE/SMC Clinical Guidelines.

Exclusion Criteria:

* Maintenance oral corticosteroid treatment within the past four weeks.
* Acute exacerbation requiring oral corticosteroids in the four weeks prior to consent.
* Other clinically significant medical disease or uncontrolled concomitant disease despite treatment that is likely, in the opinion of the investigator, to require a change in therapy or impact the ability to participate in the study or be significantly worsened by oral corticosteroids.
* History of current alcohol, drug, or chemical abuse or past abuse that would impair or risk the subject's full participation in the study, in the opinion of the investigator.
* Treatment with an investigational agent within 30 days of Visit 1 (or five half-lives of the investigational agent, whichever is longer).
* Women of child-bearing potential who are pregnant, lactating, planning pregnancy during the study period or are unwilling to use a highly effective form of contraception.
* Known hypersensitivity to prednisolone or its excipients.
* Previous psychiatric adverse reactions to steroid therapy in the past.
* Concomitant medication with systemic anti-fungals such as ketoconazole, retinoids, tetracycline, other systemic immunosuppressants e.g. ciclosporin, azathioprine, mycophenolate and live vaccines during the crossover trial.
Azilsartan in Chinese Patients With Mild and Moderate Hypertension

A phase 3 clinical study to evaluate the safety and efficacy of Azilsartan in Chinese hypertension patients


Eligibility Criteria:
Inclusion Criteria:

1. 18-70 years of age (including 18 and 70 years of age), male or female;
2. diagnosed with mild to moderate essential hypertension;
3. clinic diastolic and systolic blood pressure need to meet the following two conditions: 3 times mean sitting diastolic blood pressure measurements at 95mmHg-110mmHg (not including 110mmHg); 3 times sitting systolic blood pressure measured and mean value between150mmHg-180mmHg (not including 180mmHg);
4. understand clearly that voluntary to participate in the study, sign informed consent.

Exclusion Criteria:

1. severe essential hypertension (sitting systolic ≥180mmHg and / or sitting diastolic pressure ≥110mmHg), malignant hypertension, hypertensive emergency, hypertensive crisis and high blood pressure encephalopathy.
2. secondary hypertension.
3. The following hypertension and diseases: acute myocardial infarction within 6 months, the cerebral artery accident, transient ischemic attack; or dissecting aortic aneurysm, angina, II-IVClass (NYHA classification) history of heart failure Ⅱ degree atrioventricular block, sick sinus integrated disease, bradycardia (heart rate \<50 beats / min) or other antiarrhythmic drugs needed.
4. significant laboratory abnormalities include: serum potassium\> 5.5mmol / L; blood ALT or AST\> 2.5ULN; serum creatinine\> 1.5ULN.
5. unilateral or bilateral renal artery stenosis.
6. Type 1 diabetes and poor glycemic control of type 2 diabetes (HbA1c values ≥ 8%).
7. gastrointestinal lesions or gastrointestinal surgery may affect drug absorption or excretion, such as stomach-bowel resection, nearly one year activity of gastrointestinal inflammation, ulcers or gastrointestinal bleeding.
8. azilsartan sheet or olmesartan medoxomil tablets and related drugs (ARB, ACEI And renin inhibitors) allergies.
9. pregnant, lactating female patients, or during the test does not guarantee the effective collision pregnant person.
10. Obesity, body mass index (BMI)\> 30kg / m2.
11. Import of use in addition to import other types of medication trials of antihypertensive drugs, Anti-angina drugs, lithium agents, corticosteroids, licorice, estrogen, digitalis Drugs and drugs were potassium.
12. Variance of diastolic blood pressure ≥8mmHg.
13. drug or alcohol abuse within 6 months Are drinking more than two units of alcohol (1 unit = 360mL or 45mL alcohol content of 40%).

14 patients with malignant tumors. 15. hemodialysis patients or strictly limit salt therapy. 16. Participated in other clinical trials within 30 days.
Enhancing Rural Health Via Cardiovascular Telehealth for Rural Patients Implementation (E-VICTORS)

This pre-post study will evaluate the implementation of a cardiovascular telehealth platform, which will connect experts from the Wake Forest University Health Sciences (WFUHS) tertiary care center with Wilkes County Emergency Medical Services (WC-EMS) system, Wilkes Medical Center Emergency Department (ED), and The Wilkes County Health Department Public Health Community Clinic (PHCC) to improve cardiovascular care in this rural community.

This program aims to improve cardiovascular care for patients in Wilkes County by implementing a cardiovascular telehealth program designed to; a) assist WC- EMS paramedics with the early risk stratification (electrocardiogram (EKG) interpretation, vital signs, and risk scores), treatment, and transportation destination decisions in patients with acute chest pain or dyspnea, b) support Wilkes Medical Center (WMC) Emergency Department (ED) providers (physicians and advanced practice clinicians) in the evaluation, management, and disposition of patients with acute cardiovascular symptoms, and c) provide consultative expertise to the Primary Health Care Centers (PHCC) for patients seen following an EMS or ED encounter for cardiovascular symptoms.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years at time of index encounter
* Cardiovascular symptoms (chest discomfort or dyspnea consistent with possible ACS) as indicated by the treating provider

Exclusion Criteria:

* Age \<18
* Traumatic chest pain
* Dyspnea that is clearly from a non-cardiac etiology
* Patients with hemodynamic instability SBP \< 90 mmHg, HR\>160 or \<40 bpm
* Patients requiring intubation/mechanical ventilation
A Trial on the Effectiveness of Screening and Brief Problem-Solving Therapy (PST) for Elderly Patients With Psychological Problems

The aim of this study was to determine whether screening followed by brief PSC provided by primary care doctors could improve the quality of life of elderly patients with unrecognized psychological problems in primary care. The following hypotheses were tested:

1. Elderly patients screened positive of psychological problems had poorer health-related quality of life (HRQOL) than those who were screened negative.
2. Primary care doctors could be trained to provide brief PST.
3. Brief PST by a trained primary care doctor could improve the HRQOL of the elderly who were screened positive for psychological problems.

Design \& methods: A prospective single-blind randomised controlled trial (RCT) on 299 patients aged 60 or above without any known psychological diseases but screened positive for psychological problems by the Hospital Anxiety and Depression Scale (HADS). Subjects were randomised to problem-solving (PST) or video-viewing (placebo). All subjects continued with their usual care and were followed up by telephone at 6, 12, 26 and 52 weeks.Changes in SF-36 HRQOL scores, HADS scores and monthly consultation rates at 6, 12, 26 and 52 weeks within groups and between groups.

Eligibility Criteria:
Inclusion Criteria:

* Aged 60 or above
* not known to have any psychological problem
* HADS Depression score 6 or above, or Anxiety Score 3 or above
* Written consent to study

Exclusion Criteria:

* known psychological disease diagnosed by a registered doctor
* history of taking any psychotropic drug prescribed by a registered doctor within the last year;
* suicidal plan or strong suicidal thought;
* psychotic symptom;
* impairment in cognitive function; or
* communication problem.
Safety and Efficacy of Hypothermia to Treat Neonatal Hypoxic-Ischemic Encephalopathy

The purpose of this study is to investigate the effectiveness and safety of selective head cooling (SHC) in neonatal hypoxic-ischemic encephalopathy (HIE).

Hypoxic-ischemic encephalopathy (HIE) remains a major cause of neonatal death and long term disabilities. Data from animal studies have shown protective effects of mild hypothermia to both the mature and immature brain. Recently research priorities have moved from bench to bedside. Several studies have shown a trend for brain protection of mild to moderate hypothermia and mild hypothermia has emerged as a promising treatment for HIE. Therefore,the investigators organized a multi-centered randomized controlled trial of selective head cooling (SHC) combined with mild systemic hypothermia in HIE newborn infants.

Eligibility Criteria:
Inclusion Criteria:

* Age up to 6 hours
* Gestational age ≥ 36 weeks and birth weight ≥ 2500 g
* Apgar score ≤ 3 at 1 minute and ≤ 5 at 5 minutes, and/or cord blood gas pH \< 7.0 or base deficit ≤ 16 mmol/L, and/or need for resuscitation or ventilation at 5 minutes of age
* Clinical signs of encephalopathy (seizures, coma, abnormal muscle tone and irregular breathing, etc)

Exclusion Criteria:

* Major congenital abnormalities
* Infection
* Other etiology of induced brain injury
* Severe anemia (Hb \< 120 g/L)

Eligible infants assessed for the severity of HIE according to criteria of the Neonatal Association of Chinese Academy of Pediatrics 25 modified from Sarnat and Sarnat 26 in 1986
Photobiomodulation and Parkinson

This study aimed to assess the effects of transcranial photobiomodulation in patients with Parkinson's disease (PD).

Thirty-five patients with idiopathic PD were randomly assigned to a photobiomodulation (n=17, \[mean±SD\] 72±7 years) or sham group (n=18, 70±8 years) during 9 weeks (2 sessions/week). The primary endpoint was the motor portion of the Movement Disorders Society-United PD Rating Scale. Secondary endpoints were the Scales for Outcomes in PD, static posturography, walking ability (ten-meter walk test \[TMWT\]) and functional mobility (timed up and go \[TUG\] test).

Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with idiopathic PD.
* Stage 1-2 on the Hoehn and Yahr Scale.
* Having no neurological condition other than PD.
* Being able to stand for 2 minutes and walk 10 meters without assistance.
* Having no severe dyskinesias or "ON-OFF" phases.

Exclusion Criteria:

- Do not follow inclusion criteria.
A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia

This is a Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Determine the the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants with Schizophrenia


Eligibility Criteria:
Key Inclusion Criteria:

Male or female participants between 18 to 65 years of age (inclusive) at the time of consent.

Participant is experiencing an acute exacerbation or relapse of symptoms, with onset (≤) 2 months prior to screening

1. The participant requires hospitalization for this acute exacerbation or relapse of symptoms.
2. If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening.

Participants who are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by meeting ALL of the following criteria at the screening and baseline visits:

1. Participant must have a PANSS total score ≥ 80, AND a PANSS item score ≥ 4, moderate or greater, for ≥ 2 of the following Positive Scale (P) items: i. Item 1 (P1; delusions) ii. Item 2 (P2; conceptual disorganization) iii. Item 3 (P3; hallucinatory behavior) iv. Item 6 (P6; suspiciousness/persecution);

   AND
2. Participant must have a CGI-S score ≥ 4.

Participants who have received previous outpatient antipsychotic treatment at an adequate dose (minimal recommended dose for the treatment of schizophrenia according to the manufacturer labeling) for an adequate duration (at least 6 weeks) and who showed a previous good response to such antipsychotic treatment (other than clozapine) in the last 12 months, according to the investigator's opinion.

Key Exclusion Criteria:

Sexually active participants or persons of childbearing potential (POCBP) who do not agree to practice 2 different clinical trial sponsor approved methods of birth control or remain abstinent during the course of the trial and for 30 days after the last dose of study drug.

Participant has had a decrease (improvement of symptoms) of ≥ 20% on the PANSS total score between screening and baseline.

Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia. Exclusionary disorders include, but are not limited to, alcohol use disorder (within past 12 months), substance (other than nicotine or caffeine) use disorder within past 12 months, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and posttraumatic stress disorder. Symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms are not the primary focus of treatment.

Participant has had psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days prior to screening.