cyrilzakka/clinical-trials huggingface dataset:
A Study of Opevesostat (MK-5684) in China Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (MK-5684-001)

The primary objectives of this study are to evaluate the safety and tolerability of opevesostat in the treatment of male Chinese participants with metastatic castration-resistant prostate cancer (mCRPC) and to characterize the pharmacokinetic profile of opevesostat. There are no formal hypotheses to be tested in this study.


Eligibility Criteria:
The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

* Has histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology.
* Has prostate cancer while receiving androgen deprivation therapy (ADT), or post-bilateral orchiectomy, within 6 months before screening.
* Has evidence of progression \>4 weeks since last flutamide treatment or \>6 weeks since last bicalutamide or nilutamide treatment.
* Has evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue shown by CT/MRI.
* Has disease that progressed during or after treatment with at least 1 line of next-generation hormonal agents (NHAs) for hormone-sensitive prostate cancer (HSPC) or castration-resistant prostate cancer (CRPC) for at least 8 weeks (at least 14 weeks for participants with bone progression).
* Has received at least 1 line of taxane-based chemotherapy for HSPC or CRPC and have had progressed disease during or on treatment, or refused or ineligible to receive chemotherapy.
* Has a life expectancy of \>3 months.

Exclusion Criteria:

* Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.
* Has presence of gastrointestinal condition, e.g. malabsorption, that might affect the adsorption of study intervention.
* Has a history of pituitary dysfunction.
* Has poorly controlled diabetes mellitus.
* Has active or unstable cardio/cerebro-vascular disease, including thromboembolic events.
* Has undergone major surgery, including local prostate intervention (except prostate biopsy), within 4 weeks of the date of allocation.
* Has received an anticancer monoclonal antibody (mAb) within 4 weeks of allocation, or has not recovered from adverse events (AEs) due to mAbs administered more than 4 weeks before the date of allocation.
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before the date of allocation.
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any form of immunosuppressive therapy within 7 days prior to the start of study intervention.
* Has a known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Has an active autoimmune disease that has required systemic treatment in the past 2 years.
* Has a history of or current human immunodeficiency virus (HIV) infection.
* Has a concurrent Hepatitis B or Hepatitis C virus infection.
* Has a history of allogenic tissue or solid organ transplant.
Remote Ischemic Conditioning of the Human Brain in Dementia Patients

The study investigates the incidence of remote ischemic conditioning in mild cognitive impairment and dementia patients

The investigators will study the potential neuroprotection of ischemia/reperfusion (I/R) of a peripheral organ or tissue against cerebral I/R injury in people with mild cognitive impairment as well as early and middle stage dementia.

This crossover study will be held with individuals suffering from peripheral arteriopathy that can cause intermittent claudication after structured exercise, thus inducing extensive transient leg's ischemia.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of mild cognitive impairment
* Clinical diagnosis of mild dementia
* Clinical diagnosis of moderate dementia
* Peripheral arteriopathy

Exclusion Criteria:

* Clinical diagnosis of severe dementia
* Not being able to follow the exercise program for more than two days for any reason
Monitoring Patients for Developing Communicable and Opportunistic Infections and for Responding to Therapy

Patients are exposed to infectious agents regularly, regardless of their immunologic status. Traditionally clinicians have decided to institute prophylaxis based on epidemiologic factors, skin test (i.e. PPD), or immunologic parameters. A quantitative and specific method that is non-invasive, such as quantitative PCR, would be desirable to more precisely define those who would benefit from prophylaxis. Similarly, when patients develop disease and are being treated, quantitative, non-invasive techniques are needed to assess response to therapy. This project is designed to develop and test quantitative tests using blood, urine, or sputum samples.

Patients are exposed to infectious agents regularly, regardless of their immunologic status. Traditionally clinicians have decided to institute prophylaxis based on epidemiologic factors, skin test (i.e. PPD), or immunologic parameters. A quantitative and specific method that is non-invasive, such as quantitative PCR, would be desirable to more precisely define those who would benefit from prophylaxis. Similarly, when patients develop disease and are being treated, quantitative, non-invasive techniques are needed to assess response to therapy. This project is designed to develop and test quantitative tests using blood, urine, or sputum samples.

Eligibility Criteria:
Patients older than 18 years of age.

Ability to give informed consent.

No medical contraindication to phlebotomy.

Epidemiologically at risk for tuberculosis or for an opportunistic infection.

Patients who can identify a responsible health care provider as someone willing to provide clinical information and to receive medically important information.
Pilot Study of the Effects of Playing Golf on People With Dementia

The research question for this study is whether golf is a suitable physical activity for people with dementia (PWD). It follows a qualitative pilot study in Lincoln where PWD enjoyed the activity and caregivers appreciated the service. Golf combines many desirable elements in a physical activity programme that include being outdoors, social, cognitively challenging, no reaction-time component, and being a typical everyday activity. The length of time that golf sessions last could also offer a potential respite from care for caregivers.

Participants will be people with dementia and their caregivers. Eligibility criteria will include having been clinically diagnosed with dementia, being able to stand on one leg for at least six seconds to ensure participants are able to balance sufficiently well to be able to play golf. The study will be undertaken at The London Shire Golf Club, with the golf training provided by the Golf Trust, which is a charitable foundation experienced in providing golf training to people with a range of different disabilities.

The randomised controlled trial study will last 16 weeks, with a partial crossover design. The experimental group with have two eight-week periods of golf while the control group will have eight weeks without golf, then the golf intervention. There will be two 150-min sessions each week, starting with 30 minutes socialising, then 90 minutes playing golf, then 30 minutes socialising. The golf sessions will progress from putting, to chipping, and then a full swing, with sessions taking place on a nine-hole golf course. Participants will be evaluated before and after each eight-week period for physical function, physical activity level, cognitive function, and quality of life. Their caregivers will also provide information related to the PWD in terms of quality of life and psychopathology in dementia, as well as their own quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed with dementia (any dementia)
* Receiving post-diagnostic support
* The capacity to give informed consent
* The physical capacity to play golf as determined by a single-leg stance test of balance

Exclusion Criteria:

* Unable to give informed consent
* Without the physical capacity to play golf, as determined by a single-leg stance test of balance
A Phase I Clinical Trial of SyB L-0501 in Combination With Rituximab to Patients With Aggressive B-cell Non-Hodgkin's Lymphoma

The purpose of this study is to assess the safety of SyB L-0501 in combination with Rituximab to patients with aggressive B-cell non-Hodgkin's lymphoma, and to explore the recommended dose for the Phase II clinical trial.


Eligibility Criteria:
Inclusion Criteria:

Aggressive B-cell non-Hodgkin's lymphoma patients with prior therapy who satisfy the conditions listed below. No restrictions regarding gender.

* Patients with the following histologically confirmed CD20(+) B-cell non-Hodgkin's lymphoma:

  1. Diffuse large B-cell lymphoma
  2. Mantle cell lymphoma
  3. Transformed lymphoma
  4. Follicular lymphoma (Grade 3)
* Fail to CR in prior chemotherapy, or relapse following CR or recurrence following PR.
* Patients who are judged to carry no effect from the prior therapy (cancer chemotherapy, antibody therapy and radiation/ radiotherapy.
* Patients aged from 20 to 75 years at the time informed consent is obtained
* Patients with adequately maintained organ functions (e.g., bone marrow, heart, lung, liver, and kidney functions)
* Patients who can be hospitalized during the first cycle
* Patients capable of personally giving voluntary informed consent in writing to participate in the study

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded.

* Patients with serious complications (hepatic or renal failure)
* Patients with complications or medical history of serious cardiac disease (e.g., myocardial infarction, ischemic heart disease)
* Patients with serious gastrointestinal symptoms (e.g., severe nausea, vomiting, or diarrhea)
* Patients positive for HBs antigen, HCV antibody, or HIV antibody
* Patients who received other investigational drug or unapproved medication within 3 months before registration in this study
* Patients who had history of hematopoietic stem cell transplantation or radioimmunotherapy
* Patients who are pregnant, of childbearing potential, or lactating
* Patients, whether male or female, who do not agree to contraception
* Patients otherwise judged by investigator or sub investigator to be unsuitable
A Study to Assess the Safety, Tolerability, and Efficacy of Namilumab in Participants With Active Cardiac Sarcoidosis

A Randomized, Double-blind, Placebo-controlled, Study with an Open-label Cohort.

Study was terminated after a single participant had received 2 doses.

Eligibility Criteria:
Inclusion Criteria:

* Male or female age ≥18 years
* Able and willing to provide written informed consent, which includes compliance with study requirements and restrictions listed in the consent form
* History of documented sarcoidosis (must include histological confirmation, from any organ, in the subject's medical history or records)
* Meet Heart Rhythm Society Cardiac Sarcoid Diagnostic Criteria (modified)
* Female subjects must agree to use an approved highly effective birth control (BC) method
* Male subjects must agree to, and attest that, female partners of childbearing potential are using one of the allowed highly effective methods of contraception
* Body Mass Index (BMI) \<40 kg/m2 at Screening.
* Vaccination for COVID-19 with completion of the primary series at least 2 weeks prior to randomization

Exclusion Criteria:

* Hospitalized for any respiratory or cardiac illness ≤30 days prior to Screening
* Known pulmonary hypertension requiring therapy
* Autoimmune disease other than sarcoidosis likely to require treatment during the subject's participation in this study
* Symptoms and/or signs of extracardiac sarcoidosis that are likely to warrant treatment in addition to that required for the subject's cardiac disease
* Estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73 m2 (Modification of Diet in Renal Disease \[MDRD\] equation) or requiring renal replacement therapy
* Hemoglobin ≤9.5 g/dL
* Participation in another interventional clinical trial within 6 months prior to Screening and throughout the duration of participation in this study
* Systolic blood pressure (SBP) \<90 or \>180 mm Hg; Diastolic blood pressure (DBP) \<60 or \>110 mm Hg at Screening
* Has documented laboratory-confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR) or other approved clinical testing ≤3 months prior to randomization
* Significant valvular heart disease known or anticipated to require surgical repair or replacement during the subjects' participation in this study
* Female subjects who are pregnant or breastfeeding or intend to be, during the study
* History of severe allergic or anaphylactic reactions to therapeutic proteins or known sensitivity to namilumab or to its inactive components
* Any other acute or chronic medical condition, that in the judgment of the Investigator or Sponsor, may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results, and would make the participant inappropriate for entry into this study

Other protocol-defined inclusion/exclusion criteria may apply.
Evaluation of Fetal Cardiac Function in Rheumatic Heart Disease (RHD) Patients

The goal of this study is to evaluate fetal myocardial performance in patients with heart diseases in comparison to normal pregnant patients.

Cardiac diseases affect 1-4% of pregnancies of industrialized countries,and the number of patients who develop cardiac problems during pregnancy is increasing.

Congenital heart diseases, ischemic heart and cardiac arrhythmias are the most dominant causes. In developing countries, rheumatic heart disease remains prevalent. Pregnancy induces haemodynamic changes with increased intravascular volume which may not only poses a risk of maternal death but also of serious morbidity such as heart failure, stroke and cardiac arrhythmia.

The fetus is not spared.Previous reports revealed a significant reduction in fetal growth rates associated with maternal heart disease.There is also association with preterm delivery and reduced birth weight. The presence of maternal cyanosis and a reduced cardiac output are the most significant predictors.

Accurate and reliable measurement of fetal cardiac function could be valuable for making the diagnosis and for fetal surveillanceThe most suitable parameters for assessing fetal cardiac function will mainly be determined by the cause of the dysfunction. Abnormal values of ejection fraction or cardiac output are usually found in the late stages of deterioration, and therefore more sensitive parameters have been proposed for earlier diagnosis and monitoring of fetal cardiac dysfunction. In most cases of cardiac dysfunction, diastolic parameters (such as DV or IRT) are the first to be altered, reflecting impaired relaxation and compliance due to a stiffer or less effective heart. Similarly, parameters reflecting longitudinal function (such as annular displacement or velocities) are typically affected in the early stages as compared to radial function (such as ejection fraction).

The goal of this study is to evaluate fetal myocardial performance in patients with heart diseases in comparison to normal pregnant patients.

Eligibility Criteria:
Inclusion Criteria:

1. Compensated heart disease.
2. singleton pregnancy
3. Normal placental location
4. Have no associated hypertension, diabetes or any other medical disorders affecting pregnancy

Exclusion Criteria:

The patients have hypertension, diabetes or any other medical disorders affecting pregnancy.
Study to Compare the Oestradiol Suppression, Clinical Efficacy and Safety of Two Formulations of Triptorelin (Triptorelin Pamoate PR 3-month and Triptorelin Acetate PR 1-month) in Chinese Subjects With Endometriosis

To assess the efficacy of triptorelin pamoate prolonged release (PR) 3-month formulation in Chinese female subjects with endometriosis by demonstrating the non-inferiority of triptorelin pamoate PR 3-month formulation injected once as compared to triptorelin acetate PR 1-month formulation injected 3 times consecutively.


Eligibility Criteria:
Inclusion Criteria:

* Female subjects aged from 18 to 45 years inclusive at the date of informed consent.
* A history of active and regular menstrual cycles of 21 to 35 days (inclusive) in the 6 months prior to the screening visit.
* A diagnosis of endometriosis, confirmed by laparoscopy or laparotomy within10 years prior to the screening visit.
* Requires treatment with a Gonadotrophin releasing hormone (GnRH) agonist for a period of 6 months in the judgement of the investigator.

Exclusion Criteria:

* A current history of undiagnosed abnormal genital bleeding.
* Received treatment with a GnRH agonist within 6 months prior to the screening visit.
* Received any other hormonal treatment within 3 months prior to the screening visit (oestrogens, progestogens, danazol, gestrinone and cyproterone acetate etc).
* Chronic pelvic pain that is not caused by endometriosis, that would interfere with the assessment of endometriosis-associated pelvic pain.
A Study of Bone Marrow Transplantation Using Fully-Matched Relatives as Donors for Patients With Hematological Malignancies

This research study uses a drug called cyclophosphamide to decrease the incidence of GVHD in matched sibling hematopoietic stem cell transplant. In doing so, the goal of the study is to increase overall survival.

This research protocol has been developed for patients undergoing matched-sibling hematopoietic stem cell transplant (HSCT). The patients who are treated according to this 2 step allogeneic HSCT protocol will receive cyclophosphamide to induce in-vivo tolerization of both autologous and allogeneic lymphocytes, followed by an allogeneic CD34-selected HSCT. The primary research questions relate to immune reconstitution, incidence of GVHD, and relapse in patients who receive lymphocyte treatment of this type in allogeneic HSCT and how it impacts overall survival.

Eligibility Criteria:
Inclusion Criteria:

1. Any patient with a hematologic or oncologic diagnosis in which allogeneic HSCT is thought to be beneficial, and in whom front-line therapy has already been applied. Patients will be considered high-risk if they have any of the following:

   1. Age \> 50 years
   2. ECOG Performance status of \<2
   3. Acute leukemia: requiring more than one chemotherapy regimen to obtain 1st CR; second or greater CR, 1st relapse; any ph+ ALL
   4. CML 2nd chronic phase, accelerated phase, or blastic phase
   5. MDS with IPS of Intermediate 2 or greater
   6. Any myeloproliferative disorder
   7. Hodgkin lymphoma: relapsed, refractory, or primary induction failure
   8. Non-Hodgkin lymphoma: relapsed, refractory, primary treatment failure, or not eligible for an autologous HSCT
   9. Other conditions not listed will be assessed as high-risk by the PI
2. Patients must have a related donor who is either HLA-identical or a one antigen mismatch at the HLA- A; B; C; and DR loci.
3. Patients must adequate organ function:

   1. LVEF of \>45%
   2. DLCO (adjusted for hemoglobin) \>45% of predicted
   3. Adequate liver function as defined by a serum bilirubin \<1.8, AST or ALT \< 2.5X upper limit of normal
   4. Creatinine clearance of \> 60 ml/min
4. Patients must be willing to use contraception if they have childbearing potential
5. Able to give informed consent

Exclusion Criteria:

1. ECOG performance status of 3 or 4.
2. HIV positive
3. Active involvement of the central nervous system with malignancy
4. Psychiatric disorder that would preclude patients from signing an informed consent
5. Pregnancy
6. Patients with life expectancy of \< 6 months for reasons other than their underlying hematologic/oncologic disorder.
Anthocyanin-Rich Table Grape Powder for Prophylaxis of Post-Operative Atrial Fibrillation

Postoperative atrial fibrillation (POAF) is a common complication following cardiac surgery and leads to worse outcomes. POAF is thought to be caused by the inflammatory state following cardiac surgery. It may be that anti-inflammatory medications could lower the occurrence of POAF, however many typical anti-inflammatory medications, such as ibuprofen, are contraindicated in the post cardiac surgery patient due to increased risks of bleeding. If a drug was identified with anti-inflammatory properties with minimal deleterious side effects, this could be broadly applied to cardiac surgery patients for the prevention of POAF. Interestingly, several small trials have shown that medications that alter transcription of inflammatory markers lead to decreased POAF. Furthermore, we have shown that phytochemicals, such as those found in grapes, have excellent bioavailability and can affect cardiac gene transcription related to inflammation. In this study, we propose to evaluate the efficacy of preoperative administration of concentrated grape powder in the prevention of POAF.


Eligibility Criteria:
Inclusion Criteria:

* Males and female patients (age 50-79) at the Mitral Valve Clinic/CVC undergoing elective cardiac surgery for mitral valve repair without the Cox MAZE procedure (MVR patients also undergoing CABG and/or tricuspid valve repair are also eligible)
* In sinus rhythm (no pre-operative atrial fibrillation)

Exclusion Criteria:

* Age ≥ 80 years
* Diagnosed pre-operative chronic or paroxysmal AF
* Prior ablation procedure for AF
* Previous cardiac surgery
* Implanted pacemaker
* Active smoker
* Comorbidities such as congenital or cardiac re-operation
* Use of antiarrhythmic agents
* Active inflammatory or infectious disease or malignancy
* Diagnosed autoimmune disease
* Corticosteroid or other immunomodulatory or immunosuppressive medication
* Risk factors for POAF including low ejection fraction (EF) (EF\<50%), left atrial (LA) dilation (LA\>5.0 cm), and high degree of mitral regurgitation (grade 3-4).
Combivent® CFC Metered Dose Inhaler (MDI) in Moderate to Severe Asthma

The purpose of this study is to demonstrate the superior bronchodilator efficacy of inhaled Combivent® CFC MDI vs. Albuterol HFA MDI in moderate to severe asthma patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient greater than or equal to 18 years of age,
* non-smokers,
* diagnosed with asthma, with an FEV1 less than or equal to 70 percent of predicted normal,
* stable use of Beta agonist
* daily use of inhaled steroids for one year

Exclusion Criteria:

* Patients with other significant diseases other than asthma, requiring oxygen,
* intubated within 5 years,
* asthma exacerbation within 6 weeks of trial,
* use of unstable doses (greater than 10 mg/day of prednisone or equivalent) of steroids,
* participating in another interventional trial
Morphine Added to Ropivacaine for FICB for Postoperative Analgesia

prospective, randomized double blinded study to investigate the effects of morphine as an adjuvant to ropivacaine on FICB


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing elective femur surgery under spinal anaesthesia

  * Age group (18-65 years)
  * ASA physical status I and II

Exclusion Criteria:

* • Not willing to participate in the study

  * Other painful co-morbidities (neuropathies)
  * Allergy or any contraindication to study medication
  * Psychiatric disorder
  * Coagulopathy
  * Infection at the site of the block
  * Use of other modes of anaesthesia or analgesia besides spinal anaesthesia.