cyrilzakka/clinical-trials huggingface dataset:
Ovarian Tissue Cryopreservation and Subsequent Auto-Transplantation for Female Cancer Patients (HKCH)

Ovarian tissue freezing is an ideal option for these patients as it can be performed immediately and does not need any time for ovarian stimulation. We hope we can develop this service in our locality to allow more young female cancer patients to have their fertility preserved.

To date, transplantation of cryopreserved ovarian tissue has resulted in births of at least 130 children but data on transplantation of ovarian tissue removed before puberty are scarce.

During ovarian tissue cryopreservation (OTC), it is possible to freeze isolated oocytes. In 2003, Revel et al described for the first time oocyte isolation in children younger than 12 years with seven, eight and seven oocytes isolated from the ovarian cortex of patients aged 5, 8 and 10 years, respectively.

At this moment, financial constraint is another great hindrance to fertility preservation in Hong Kong as the procedure is not cheap. Cryopreservation of gametes and embryos involving assisted reproductive technology is expensive and the costs of fertility preservation impose a great burden to these cancer patients on top of the great expenses for their chemo- or radiotherapy. It is almost impossible for underprivileged families.

Young cancer patients may often need immediate gonadotoxic treatment for their cancer, just like those with haematological cancers. In these patients, egg or embryo freezing is not possible as it takes at least 8-12 days' time for ovarian stimulation. Ovarian tissue freezing is an ideal option for these patients as it can be performed immediately and does not need any time for ovarian stimulation. We hope we can develop this service in our locality to allow more young female cancer patients to have their fertility preserved.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged from 0-35 years old and diagnosed with cancer e.g., leukaemia, myeloproliferative or myelodysplastic diseases, lymphoma, bone tumours, neurological neoplasms and sarcoma, Paediatric bone marrow transplant patients
* Patients with any illness or who will undergo any type of treatment that may cause irreversible damage to their fertility, such as extensive abdominal surgery, high toxicity medication and treatments;
* Patients suffering from hormone-sensitive malignancies who will undergo medical treatment, such as radiotherapy and chemotherapy that is liable to damage their ovaries and deter them from conception in the future.

Exclusion Criteria:

Patients with no anticipated oncologic therapies Patients who are pregnant Children with one ovary Children deemed high risk for perioperative complications Patients unable to provide consent/assent (i.e. significant psychiatric problems/cognitive delay)

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Effects of Music Based Intervention (MBI) on Pain Response and Neurodevelopment in Preterm Infants

Pilot prospective randomized, double blinded, controlled study to test effect of music based intervention (MBI) on pain response and neurodevelopment in preterm infants.

Aim 1: Premature infant pain profiles (PIPP) include physiologic, behavioral, and contextual measures which identifies differences in pain responses between music-based intervention (MBI) and controls while still in the neonatal intensive care unit (NICU). Central EEG amplitude changes have been time-locked with painful procedures in term infants. We will explore if PIPP scores and central EEG amplitude changes are attenuated with MBI in comparison to controls.

Hypothesis 1: MBI will show improved pain responses, with lower PIPP scores and attenuated central EEG amplitude changes during painful procedures, in comparison to the control cohort.

Aim 2: EEG is a surrogate marker for real time brain function during sleep-wake cycles. Because preterm brain networks develop during sleep, sleep duration is a strong indicator of brain maturation. Serial biweekly EEGs of preterm infants can quantify sleep duration trends and track MBI's influence on sleep. To enhance objectivity, innovative EEG machine-learning tools will be applied to the analyses.

Hypothesis 2: MBI will enhance preterm EEG brain maturation in comparison to controls.

Due to the natural limitations of evaluating immature neonatal nervous systems, ERPs have been utilized to study early neurodevelopment. ERPs quantify electrical brain potentials changes time-locked with a stimulus. Auditory ERPs performed at 1 month corrected age evaluates attention and discrimination between familiar and novel stimuli - early neurodevelopmental signs of recognition memory function and perceptual learning.

Hypothesis 3: ERPs at 1 month corrected age will show that MBI has a greater impact on early neurodevelopment when compared to controls.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infant born at 30 weeks (+/- 2 weeks)
* Medically stable

Exclusion Criteria:

* Treatment for major organ system disease
* Significant neurological disorder including, but not limited to, abnormal neurological examination, neonatal abstinence syndrome, intraventricular hemorrhage, seizures, meningitis, or congenital brain malformations
* Scalp lesions affecting EEG placement
Sickle Cell Disease (SCD) Bone Pain Study

A prospective study to determine how low bone mineral density and/or vertebral compression fractures associate with pain in adults with sickle cell disease

The investigators hypothesize that adults with sickle cell disease (SCD) and low bone density and/or vertebral compression fractures on a dual X-ray absorptiometry (DXA) scan (adjusted for age, sex, SCD genotype, relevant labs, presence of osteonecrosis, and SCD-modifying therapies) will report more severe pain than those with normal bone density or no vertebral fractures. The Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me) is a validated patient-reported outcome measure of physical, mental, and social health in adults with SCD. This cross-sectional observational study involves obtaining a baseline DXA scan, vertebral fracture analysis (VFA) and pain assessment using ASCQ-Me pain impact scores. The investigators plan to recruit 50 adults with SCD followed at University of California Davis Medical Center between Nov 2022- Dec 2023 and anticipate enrolling up to 4 adults with SCD per month. The study endpoints are listed below:

* To determine the association between bone density Z-scores and ASCQ-Me pain impact scores in a prospective cohort of adults with SCD
* To study the association between Spine Deformity Index scores (SDI, a proxy for vertebral fracture analysis) and ASCQ-Me pain impact scores in a prospective cohort of adults with SCD
* To assess the correlation between baseline hematological and biochemical laboratory parameters (including bone biomarkers), bone density, and/or vertebral fractures in a prospective cohort of adults with SCD

The investigators' goal is to complete primary data analysis by Mar 2024. As an exploratory endpoint, 1cc of serum and 5cc of urine will be collected from each study participant once (at baseline), after an overnight fast, for bone biomarker analyses.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years with SCD (any genotype, confirmed by hemoglobin electrophoresis or high performance liquid chromatography)
* Ability to provide written informed consent
* Ability to lay on a DXA scanner
* Negative urine pregnancy test for women of childbearing potential at study entry

Exclusion Criteria:

* Pregnant women
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Prisoners
* Hospitalizations (any cause) within 2 weeks of study entry
Study of Rehabilitation Therapy on Patients After Acute Myocardial Infarction

The purpose of this study is to determine whether exercise rehabilitation can reduce mortality, reinfarction or heart failure of patients after acute myocardial infarction.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ST-elevated myocardial infarction
* Heart function class I-II(killip classification)
* Agree to take cardiopulmonary exercise testing before discharge
* Signature of the informed consent document

Exclusion Criteria:

* History of myocardial infarction
* Acute myocardial infarction with severe complications(such as pulmonary edema, severe cardiac arrhythmia or cardiogenic shock)
* Atrial fibrillation
* Other severe diseases, such as HIV infection, malignant tumor or chronic diseases of liver, kidney or pulmonary
* Not be capable of exercise training
Prospective Multicenter Registry Study to Assess the Frequency of Lynch Syndrome Among Patients With Colorectal Cancer

Prospective multicenter registry study to assess the frequency of Lynch syndrome among patients with colorectal cancer in Russia

Blood and tumor samples will be obtained from enrolled patients. 4 ml of venous blood samples will be taken into a tube with EDTA and stored at -20 0C. Tumor samples will be taken during endoscopy or surgical treatment, embedded in paraffin and stored at room temperature.

Microsatellite instability in the tumor tissue will be determined by any method available in the participating center (immunohistochemical or molecular genetic study). In case of detection of microsatellite instability/deficiency in the repair system of unpaired bases blood samples will be analyzed for the fact that germinal mutations in the DNA mismatch repair genes.

Patients will be followed up for 5 years after enrollment. During follow up correlation of spectrum of germinal mutations with clinical data, effectiveness of therapy with immune checkpoint inhibitors, the spectrum of malignant neoplasms in the families of patients with Lynch syndrome, the impact of the presence of microsatellite instability/deficiency in the DNA mismatch repair genes on treatment tactics in the Russian Federation will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent;
* Patients with histologically verified colon adenocarcinoma or patients with histologically verified synchronous neoplasms who have not previously received treatment for a second tumor;
* Age ≥ 18 years;
* Absence of antitumor treatment for a real tumor (it is allowed to include patients who have a history of antitumor treatment for other malignant tumors, if the period after treatment is more than 12 months).
* The ability of the patient, according to the Researcher, to fulfill the requirements of the Protocol;

Exclusion Criteria:

- Patients receiving chemotherapy or radiotherapy for colon cancer at the time of screening
Trevo® Retriever Registry (China)

Trevo® Retriever Registry (China) is to assess real world performance of the FDA cleared Trevo Retriever intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke in China.

Trevo Registry (China) is a prospective, open-label, multi-center study, and it is the first Stryker China trial. This trial assesses real world performance of the Trevo® Retriever which is intended to restore blood flow in the neurovasculature by removing thrombus in subjects experiencing ischemic stroke. Total of 200 subjects among up to 15 sites in China local will participate in this trial. The primary endpoint is revascularization status assessment at the end of the procedure using the modified TICI score.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18
2. Subjects experiencing acute ischemic stroke due to a large vessel occlusion who are eligible and suitable for restoration of blood flow using any approved Trevo Retriever in the neurovasculature to remove thrombus
3. Trevo Retriever is planned to be the primary mechanical neuro-thrombectomy device to remove the thrombus
4. Subject or subject's legally authorized Representative (LAR) has signed the study Informed Consent Form
5. Subject willing to comply with the protocol follow-up requirements

Exclusion Criteria:

1. mRS \>2
2. Any known coagulopathy
3. Anticipated life expectancy less than 3 months
4. Known absolute contraindications to the use of required study medications or agents (e.g., heparin, aspirin, clopidogrel, radiographic contrast agents, etc.)
5. Preexisting neurological or psychiatric disease that would prevent complete the study required evaluations
6. The subject is participating in another mechanical neuro-thrombectomy device trial or any other clinical trial where the study procedure or treatment might confound the study end point.
A Study of LY3209590 in Japanese Participants With Type 2 Diabetes

The main purpose of this study is to evaluate the safety of a study drug known as LY3209590 in Japanese participants with type 2 diabetes. Side effects and tolerability will be documented. Blood samples will be taken to compare how the body handles the drug and how it affects blood sugar levels. The study will last about four weeks, not including screening. Screening is required within 4 weeks before the start of the study.


Eligibility Criteria:
Inclusion Criteria:

* Have T2DM diagnosed at least 1 year ago
* Have hemoglobin A1c (HbA1c) ≥7.0% and ≤10.0% with fasting plasma glucose (FPG) ≥126 milligrams per deciliter (mg/dL) or HbA1c ≥6.5% and \<7.0% with FPG ≥144 mg/dL at screening
* Have body weight ≥54 kilograms and a body mass index \>18.5 and ≤40.0 kilograms per square meter at screening

Exclusion Criteria:

* Have received a total daily dose of insulin \>1.2 units per kilogram at screening
* Have taken any glucose-lowering medications, other than basal insulin, metformin and dipeptidyl peptidase-IV inhibitor, in the past 3 months before screening
* Have a history of multiple and/or severe allergies to drugs or foods, or a history of severe anaphylactic reaction
* Have a history of heart block or a repeated demonstration of abnormality in the 12-lead electrocardiogram at screening, which in the opinion of the investigator, increases the risks associated with participating in the study
PD of VAY736 in Patients With Primary Sjögren's Syndrome

This study was designed to evaluate the safety, tolerability, pharmacokinetics and therapeutic efficacy of a single intravenous infusion of VAY7346 monoclonal antibody in pSS patients

Patients were enrolled in 2 sequential cohorts:

Cohort 1: 6 patients received 3 mg/kg or Placebo (2:1 ratio) Cohort 2: 21 patients received 10 mg/kg, 3 mg/kg or Placebo (6:1:3 ratio)

At week 24 the blind was broken to assess continuation in the trial:

* If a patient received VAY736 and their B cell recovery was demonstrated at Week 24, then patients completed the trial.
* If a patient received VAY736 and their B cell recovery was NOT demonstrated at Week 24, then patients were followed up until B cell recovery was demonstrated
* If a patient received placebo, they were offered the option of receiving open-label VAY736 (10 mg/kg) in a separate treatment arm.

Eligibility Criteria:
INCLUSION CRITERIA:

* Fulfilled revised European US consensus criteria for pSS
* ESSDAI value ≥ 6
* Elevated serum titers at screening of ANA (≥ 1:160)
* Seropositive at screening for anti-SSA and/or anti-SSB antibodies
* Stimulated whole salivary flow rate at screening of \> 0 mL/min

EXCLUSION CRITERIA:

- Prior or previous use of (specific dosages and intervals prior to study start may apply): B-cell depleting therapy (e.g., rituximab), Prednisone, anti-BAFF mAb, CTLA4-Fc Ig (abatacept), anti-TNF-α mAb, cyclophosphamide, azathioprine and medications known to cause dry mouth.

Hydroxychloroquine or methotrexate in a consistent dose for ≥ 3 months prior to randomization is allowed

* Active or recent history of clinically significant infection
* Vaccination within 2 month prior to study
* History of primary or secondary immunodeficiency
Effect of Large Volume Paracentesis on Fatigue in Cirrhosis

The purposeof this study is to determine the effect of a large volume paracentesis (procedure in whihc a catheter is placed to remove fluid from the abdomen) on the severity of fatigue i patients with cirrhosis (severe scarring of the liver) and large volume ascites (fluid in the abdomen).


Eligibility Criteria:
Inclusion Criteria:

* ambulatory patient with cirrhosis
* baseline Cr \<2
* ability to complete psychometric testing
* refractory ascites

Exclusion Criteria:

* Cr \>2
* history of Gastrointestinal bleed
* history of infection
* history of renal failure
Study to Compare the Anti-tetanus Neutralizing Antibody Titers and Safety of TNM002 Injection With Human Tetanus Immunoglobulin or Placebo in Adult Volunteers

The primary objective is to compare the anti-tetanus neutralizing antibody titers of TNM002 Injection with human tetanus immunoglobulin (HTIG) following a single intramuscular (IM) injection in Chinese adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Chinese male or female adults aged ≥ 18 years;
2. Healthy volunteers or volunteers with stable chronic diseases;
3. Volunteers who provide signed written informed consent form.

Exclusion Criteria:

1. History of allergy to the investigational product, human immunoglobulin preparation or any component of other therapeutic monoclonal immunoglobulins;
2. Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation;
3. History of alcohol or other substance abuse.
A Phase I Study of TAS-102 in Patients With Advanced Gastrointestinal Tumors.

The purpose of this study is to investigate the safety and determine the maximum tolerated dose of TAS-102 administered in combination with CPT-11 in patients with advanced gastrointestinal tumors.

This is an open-label, non-randomized, dose-escalation, Phase 1 study of TAS-102 administered in combination with CPT-11. The study will be conducted in 2 parts: a Dose Escalation Phase (Part 1) to determine the maximum tolerated dose and an Expansion Phase (Part 2) to further evaluate the safety, pharmacokinetics, and preliminary efficacy of the maximum tolerated dose. Patients will be assigned to sequential dose-level cohorts with each cohort corresponding to a pre-specified dose of TAS-102 and CPT-11 combination. Escalation to the subsequent dose level will occur only after the previous dose level is determined to be safe.

Eligibility Criteria:
Inclusion Criteria:

1. Has provided written informed consent
2. Has advanced gastrointestinal tumors refractory to at least 1 chemotherapy
3. ECOG performance status of 0 or 1
4. Is able to take medications orally
5. Has adequate organ function (bone marrow, kidney and liver)
6. Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.

Exclusion Criteria:

1. Has had certain other recent treatment e.g. major surgery, extended field radiation, anticancer therapy, received investigational agent, within the specified time frames prior to study drug administration
2. Presence of serious illnesses or medical condition(s) e.g. brain metastases, systemic infection, heart failure
3. Has unresolved toxicity of greater than or equal to CTCAE Grade 1 attributed to any prior therapies
4. Known sensitivity to TAS-102, CPT-11, Bevacizumab, or their components
5. Is a pregnant or lactating female
6. Has had either partial or total gastrectomy
Vitamin D Supplementation And Varicella Zoster Virus Vaccine Responsiveness In Older Long-Term Care Residents

This is an ancillary study to a randomized controlled trial of high dose vitamin D in older long-term care residents (NCT01102374). In this study, a subset of trial subjects will receive the zoster vaccine and the investigators will determine the immunological response to the vaccine in this older, frail population, as well as the association between vitamin D and immunological outcomes.

Objectives

1. To determine the increase in Varicella-zoster virus (VZV)-specific cell-mediated immune response from pre-zoster vaccination to 3 weeks post-vaccination in nursing home residents after 4 months of high dose vs. standard dose vitamin D3 supplementation.
2. In the same participants as Aim 1, to measure the association between pre-zoster vaccination 25-hydroxyvitamin D \[25(OH)D\] levels and the increase in VZV-specific cell-mediated immune response from pre- vaccination to 3 weeks post-vaccination.
3. Characterize the phenotypic and functional VZV-specific T cell responses to Zostavax, including memory, effector, Th1/Th2, and homing receptor-bearing T cells in the high compared to low ELISPOT responders.

Hypotheses

1. At baseline, higher serum 25(OH)D levels will be associated with higher levels of VZV-specific cell-mediated immunity (cross-sectional).
2. At baseline, higher serum 25(OH)D levels, independent of vitamin D supplementation dose, will be associated with greater increases in VZV-specific cell-mediated immune responses to Zostavax, as measured by the interferon (IFN)-γ ELISPOT assay.
3. Compared to standard dose, high dose vitamin D3 supplementation will enhance VZV-specific cell-mediated immune response to vaccination independent of baseline serum 25(OH)D levels.

Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥ 60 years;
2. Residing in a long-term care facility;
3. Have not yet received VZV vaccine

Exclusion Criteria:

1. terminal illness (expected survival \<6 months);
2. anticipated discharge within 12 months;
3. unable to take whole or crushed tablets;
4. active cancer, except squamous/basal cell carcinoma;
5. severe malnutrition (body mass index \<18 kg/m2);
6. current immunosuppressive medications (including corticosteroids);
7. renal failure (eGFR\<15 mL/min/1.73m2);
8. currently taking \>800 IU/d vitamin D supplementation;
9. history (or strong family history) of kidney stones;
10. history of sarcoidosis or other granulomatous disorders associated with hypercalcemia;
11. elevated baseline hypercalcemia (albumin-adjusted serum calcium \>10.5 mg/dL);
12. serum 25 (OH)D level ≥40 ngl/ml at baseline;
13. inability to provide informed consent and no available healthcare proxy;
14. inability of participant or proxy to speak/understand English.
15. previous receipt of the Zostavax (anticipate \<10% of trial;
16. known allergy to gelatin, neomycin, or any other component of the vaccine.