cyrilzakka/clinical-trials huggingface dataset:
Extended Adjuvant Treatment With Letrozole in Breast Cancer Who Complete 5 Years of Toremifene

The purpose of this study is to assess Efficacy and Safety of Extended Adjuvant Treatment With Letrozole in Postmenopausal Women With Hormone Receptor Positive Breast Cancer Who Complete 5 Years of Toremifene

1. Primary purpose To evaluate disease free survival rate (DFS) after taking 36 months with Letrozole in postmenopausal women with hormone receptor positive breast cancer who complete 5 years of Toremifene
2. Secondary purpose

   * To evaluate follows after taking 36 months with Letrozole in postmenopausal women with hormone receptor positive breast cancer who complete 5 years of Toremifene.

     1. Disease Free Survival rate(DFS)-12 months, 24 months
     2. Distant disease free survival rate(DDFS), Overall Survival(OS)
   * 12 months, 24 months, 36 months c. safety
   * Change of lipid profiles
   * Mortality and morbidity due to Cardiovascular disease
   * Incidence of Fracture
   * Change of Bone density
   * Common toxic effect

Eligibility Criteria:
Inclusion Criteria:

1. Patients have undergone surgery of the breast cancer and proven histologically to be invasive breast cancer.
2. Removed the breast cancer histologically or cytologically
3. No evidence of breast cancer in controlateral breast
4. No evidence of metastasis
5. Postmenopausal Women With Hormone Receptor Positive Breast Cancer Who Complete 5 Years of Toremifene in 30 months
6. Postmenopausal state was defined the following conditions, at least one of a, b

   1. Serum FSH ≥ 30 mIU/mL
   2. Amenorrhea ≥ 1 year
7. Estrogen receptor(+) or Progesterone receptor(+)
8. No Evidence of Recurrence

Exclusion Criteria:

1. Patient with hormone receptor negative
2. Patients with malignancies
3. Patients with other aromatase inhibitor and chemotherapy
4. Patients with Other hormone therapy and Hormonal replacement therapy
5. Patients with Hormone replacement therapy during taking Toremifene
6. Estimated life expectancy of \<12 months
7. WBC\<3,000/mm3 or Platelet count\<100,000/mm3
8. AST and/or ALT ≥2xUNL
9. Alkaline phosphatase ≥2xUNL
Congenital CYtoMEgalovirus Infection in VIEtnam (CYMEVIE)

To estimate the prevalence of congenital CMV infection in Vietnamese neonates and relating morbidity within 2-year follow-up. Along with evaluating the predictive value of the presence and the level of CMV replication in the first trimester in a highly seropositive population

Congenital cytomegalovirus infection (cCMV) is the main non-genetic cause of sensorineural hearing loss (SNHL), and a major cause of neuro-disability. High maternal CMV prevalence seems to be consistently associated with high prevalence of cCMV infection but the associated morbidity might be different from one population to another.

There exists no serologic marker useful to differentiate non-primary infection from primary infection. Since the morbidity of cCMV is similar between both primary and non-primary maternal infection, and to be infected in the first trimester is the major risk factor for long-term sequelae in neonates. Hence, it is needed to focus on finding markers that predict cCMV after maternal infection in the first trimester of pregnancy.

To date, the epidemiology of cCMV, the morbidity related to cCMV in Vietnamese population and the predictive value of Cytomegalovirus Polymerase Chain Reaction (CMV PCR) in maternal blood and urine in the first trimester remain unknown. Therefore, it is necessary to conduct this study.

Eligibility Criteria:
Inclusion Criteria:

* Vietnamese pregnant women in the first trimester of pregnancy and at delivery and subsequent live neonates at birth.
* Informed consent

Exclusion Criteria:

* Women under 18 years old.
* Miscarriages
* Stillbirths
* Premature delivery before 34th gestational week
* Loss to follow-up maternal monitoring.
* Participation in another interventional study that influences management of labour at delivery or perinatal morbidity or mortality.
Correlations Among Functional Performance, Muscle Strength and Weaning Rate in Mechanically Ventilated Patients

To assess the correlations among the physical functional performance, muscle strength, respiratory muscle strength and the ventilator weaning rate.

To assess the correlations among the physical functional performance, muscle strength, respiratory muscle strength and the ventilator weaning rate. Investigators use the DEMMI and FSS-ICU to evaluation the physical functional performance. And MRC score and hand dynamometer to record the muscle strength. The weaning parameters include Pi, PE, RSI,minute ventilation, tidal volume and cuff leak will be recorded. After the participant enters the Respiration Care Center, Doctor and physical therapist evaluate the consciousness and meet the inclusion criteria and the participant will received the first evaluation. The second evaluation will be held before the ventilator weaning timing.

Eligibility Criteria:
Inclusion Criteria:

* respiratory failure with mechanical ventilator use
* 48 hours after transferring to respiratory care center
* consciousness clear and can obey orders
* vital signs stable

Exclusion Criteria:

* conscious disturbance
* neuromuscular disease
* stroke
* fracture
* patho fracture
* BMI\>45
Study of Triostat in Infants During Heart Surgery

This is a study to determine the safety and efficacy of liothyronine sodium/triiodothyronine (Triostat), a synthetic thyroid hormone, when given to infants with congenital heart disease during cardiopulmonary bypass surgery.

Patients will be randomized to receive study drug or placebo and randomization will occur stratified to each diagnostic category. All patients undergo preoperative echocardiograms to provide preoperative cardiac function data. The study drug or placebo will be provided in the operating room as an iv bolus just prior to cardiopulmonary bypass and as a bolus delivered on release of the aortic cross-clamp. This will be followed by iv for 12 hours. Operative data will be collected including CPB time, aortic cross-clamp time, length and degree of hypothermia. These data will be extracted from the anesthesia record.

Eligibility Criteria:
Inclusion criteria:

Diagnosis of one of the following:

* Ventricular septal defect (VSD)
* Infant coarctation of the aorta
* Transposition of the great arteries
* Tetralogy of Fallot
* Complete atrioventricular canal defect
* Hypoplastic left heart, including patients who undergo a Norwood type procedure for aortic or mitral atresia

Patient must be scheduled for surgery.

Exclusion criteria:

* Certain additional defects and/or requirement for additional surgery.
Evaluation of Clinical Outcomes After the Use of SYSTANE® HYDRATION

The purpose of this study is to compare SYSTANE® HYDRATION to Hyabak 0.15% based on total ocular surface staining scores (TOSS) at Day 42.

Subjects will first be dispensed preservative-free 0.9% saline eye drops (saline eye drops) to be used during the Run-in phase between Screening Visit and Day 0 (Visit 1). Subjects who qualify will be randomized in a 1:1 manner to receive either treatment with SYSTANE® HYDRATION Lubricant Eye Drops or Hyabak 0.15% Eye Drops.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to attend all study visits;
* Use of non-BAK (Benzalkonium Chloride) artificial tears at least once a day, for at least 3 months prior to Screening Visit;
* Diagnosis of Dry Eye (by a health care professional) for at least 3 months prior to Screening Visit;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Women of childbearing potential who are pregnant or breast feeding;
* Any hypersensitivity to the use of the study products or an allergy to any ingredient(s) contained within study products;
* Ocular abnormalities in either eye that could adversely affect the safety or efficacy outcome;
* Active ocular infection (bacterial, viral, or fungal) or active inflammation not associated with dry eye;
* Use of chronic systemic medications: (prescription, over the counter, vitamins/supplements) on a stable dose for less than 30 days prior to Screening Visit, or any anticipated change in dosing regimen during the course of the study;
* History of ocular or intraocular surgery or serious ocular trauma in either eye within 6 months prior to Screening Visit;
* Any medical condition (systemic or ophthalmic) that may, in the opinion of the Investigator, preclude the safe administration of study products or safe participation in the study;
* Use of any topical ocular over-the-counter or prescribed medications in either eye (with the exception of artificial tears/gels/ lubricants) 2 weeks prior to Screening Visit;
* Contact lens use within 2 weeks prior to Screening Visit and unwilling to avoid contact lens use during the course of the study;
* Unwilling to avoid the use of additional artificial tears (other than the study products) throughout the study;
* Other protocol-defined exclusion criteria may apply.
TAP Block With Liposomal Bupivacaine Versus Bupivacaine in Robotic Hysterectomy

The purpose of the study is to compare pain control after robotic hysterectomy surgery using either liposomal bupivacaine or Bupivacaine when injected during a transversus abdominis plane (TAP) block. Robotic hysterectomy is when a patient is electively having robotic assisted removal of one's uterus. Both medications liposomal bupivacaine and Bupivacaine are standard of care in these types of surgeries.

Treatment technique:

The patient will be in the supine position. The transversus abdominis muscle layer will be identified with the ultrasound. Using sterile technique, skin infiltration with 2% lidocaine will occur, 2 cm medial to the ultrasound probe. An 22g Nerve block needle will then be inserted and advanced under ultrasound guidance until it is below the fascial covering of the transversus abdominis muscle layer. Gentle aspiration for air, or blood will be performed and either 30 cc of 0.25% bupivacaine with 1/200,000 parts epinephrine or 30 mL of liposomal bupivacaine mixed 1:1 with normal saline will be injected under ultrasound guidance. For each 5cc of local anesthetic injected, aspiration will be performed. Upon completion of the injection, the needle will then be removed. This will then be completed on the contralateral side. The patient will be monitored in the preoperative area until he/she is brought into the operating room for their procedure.

When the operation is complete the patient will either be discharged home or brought to the ward where each day a member of the research team will evaluate the patient for signs of complications and ask the patient their minimum and maximum pain score.

If patients have met criterion for discharge to home including pain \<4/10, independence of intravenous analgesia, and are stable for discharge medically, but are awaiting placement, the time of discharge for the purposes of the study will be the day they have met such criterion as opposed to the day of actual discharge, as this can vary depending on patient placement.

If the patient is discharged prior to 72 hours post injection, then the patient will receive one phone call at 24 hours post injection, 48 hours post injection , and 72 hours post injection +/- 5 hours. During this phone call the patient will be asked about pain score, narcotic use, overall satisfaction via a recorded patient questionnaire, quality of recovery via a quality of recovery survey, and assessed if any adverse events have occurred.

Adequate analgesia will be defined as \<3 VAS at rest, and if VAS is greater than 3 adjustments in oral or intravenous pain medications will be given as determined by the nurse.

Eligibility Criteria:
Inclusion Criteria:

* those who present for elective robotic assisted hysterectomy

Exclusion Criteria:

* non english speaking
* chronic pain
* on opioids greater than 1 weeks
* chronic anticoagulation
* allergy to local anesthetics
* use of spinal or epidural for surgery
* lack of patient cooperation
* contraindication to regional anesthesia
Oral Diclofenac for Retinal Photocoagulation in Diabetic Retinopathy

The purpose of this study was to evaluate the analgesic effect of oral potassium diclofenac in patients with proliferative diabetic retinopathy submitted to retinal photocoagulation.

Two groups of patients were followed and the effect of the treatment (diclofenac plus laser) was compared to placebo (placebo plus laser). Pain associated with treatment was recorded using a Visual Analog Scale 15 minutes after the procedure.


Eligibility Criteria:
Inclusion Criteria:

* 1)high-risk proliferative diabetic retinopathy in both eyes

Exclusion Criteria:

* 1)history of prior laser treatment or vitrectomy; 2) allergy to non-steroidal anti-inflammatory drugs; 3) any condition affecting comprehension of VAS pain score test; 4) Contra-indications for diclofenac use such as pregnancy, bleeding disorders, asthma, or renal failure; 5) use of any analgesic drug for the last 24 hours.
Study of Nivolumab in Combination With GM.CD40L Vaccine in Adenocarcinoma of the Lung

The purpose of this study is to find out what effects (good and bad) a tumor vaccine (GM.CD40L) used in combination with Nivolumab will have on participants and their cancer. Another purpose of the study is to find out the maximum tolerated dose of nivolumab in combination with GM.CD40L vaccine. Investigators also want to find out if the combination of GM.CD40L and nivolumab can boost the immune system of participants like you, and how their immune system reacts, both before and after the treatment.

This study has two parts and participants may be involved in either Phase I part or Phase II.

Phase I: Investigators plan to enroll participants in cohorts of 6 and monitor side effects over a 21 day period to determine the maximum tolerated dose (MTD) of nivolumab, which will be given in combination with GM.CD40L. This is being done since this study involves a combination of treatments that have not been studied in humans before and to find the best dose for the Phase II part of the study.

Phase II: Investigators plan to compare any clinical benefit in the participants who receive the combination of GM.CD40L vaccine with nivolumab, to participants that receive only nivolumab.

Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic diagnosis of advanced/metastatic adenocarcinoma of the lung
* Eastern Cooperative Oncology Group (ECOG) performance status of 0/1
* Chemotherapy naïve or have completed adjuvant chemotherapy for non-small cell lung cancer (NSCLC) \>6 months prior
* Adequate bone marrow, renal and hepatic function
* Must have measurable metastatic disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
* Mandatory archival tissue or willingness to undergo a fresh biopsy
* Life expectancy of greater than 6 months

Exclusion Criteria:

* Symptomatic brain metastasis or uncontrolled central nervous system (CNS) metastasis
* Pregnancy or breast feeding
* Serious uncontrolled medical disorder or active infection that would impair the participant's ability to receive study treatment
* Prior use of a PD1 or PDL1 inhibitor
* Concurrent use of other anticancer approved or investigational agents is not allowed
* Autoimmune disorders
* Prior malignancy in past 2 years
* Systemic steroids at doses greater than 10 mg/day of prednisone or the equivalent
* Any other pre-existing immunodeficiency condition (including known HIV infection)
Chloroquine + Losartan Compared to Chloroquine Alone for the Treatment of COVID-19 Pneumonia

Study design Phase 2, double blinded, single-center, 1:1 randomized clinical trial of Chloroquine vs Chloroquine/losartan for the treatment of SARS-CoV-2 pneumonia in non-critically ill subjects

Study design Phase 2, blinded, single-center, 1: 1 randomized clinical trial for the treatment of SARS-CoV-2 pneumonia in non-critically ill subjects. Two of the co-investigators and the data analyst will remain blind to group allocation until after statistical analysis.

The groups will consist of subjects receiving in one arm PO Chloroquine 450mg every 12 hours and in the other arm, in addition to chloroquine, PO Losartan 25mg every 24 hours. Study drugs will be administered for a total of 10 days enterally.

Baseline demographics and clinical characteristics will be registered and periodically during the study.

nasopharyngeal swabs will be taken every 48hrs during hospitalization to determine the presences and viral load of SARS-CoV-2, and daily EKG for QT interval monitoring.

Eligibility Criteria:
Inclusion Criteria:

1. Men or women ≥18 years.
2. Oral tolerance or access for enteral administration of medication.
3. PCR or IgM for SARS-CoV-2 positive.
4. Negative pregnancy test in case of a woman of reproductive age.
5. Signature of a document proving informed consent.
6. Hospital admission for SARS-CoV-2 pneumonia.

Exclusion Criteria:

1. New alteration of the state of alert that does not revert after interventions 60 minutes after hospital admission.
2. Mean Arterial Pressure (MAP) ≤ 65mmHg despite initial resuscitation on arrival at the centre.
3. History of allergy to chloroquine, hydroxychloroquine, piperaquine or primaquine.
4. Known patient with hearing loss.
5. Received chloroquine or hydroxychloroquine in the last 3 months.
6. Patients with cirrhosis or elevation of aspartate transaminase (AST) or alanine transaminase (ALT) greater than three times the upper normal limit.
7. Patients with calculated glomerular filtration rate by Modification of Diet in Renal Disease study equation (MDRD) \< 30ml/min 1.73 m2.
8. Patients known to be deficient in 6-phosphate dehydrogenase
9. Patients known to have retinopathy or macular disease.
10. History of acute myocardial infarction in the last 6 months, unstable angina, ventricular tachycardia, ventricular fibrillation or class III-IV heart failure according to New York Heart Association.
11. Electrocardiogram QTc interval ≥ 480 ms.
12. Patients with hypomagnesemia or uncorrected hypokalemia.
13. Patients with a history of psychiatric illness.
14. Patients who are pregnant or nursing.
15. Patients taking quinolones, dextropropoxyphene, amiodarone, flecainide, cisapride, domperidone, atazanavir or lopinavir.
16. Patients with acute pancreatitis.
17. Patients who the investigators deem unsuitable for participation in the clinical trial.
Influence of Luteolin for Two Weeks on Memory in Healthy Subjects

The goal of this clinical trial is to learn about the effect of the dietary supplement luteolin in healthy people. The main question it aims to answer is: Does luteolin have an influence on memory functions?

Participants will go trough two treatment phases. In one phase they will take 250mg luteolin twice daily for two weeks. In the other phase they will take a placebo twice daily for two weeks. A placebo is a look-alike substance that contains no active drug.

At the start and end of teach treatment phase, participants will undergo different memory testing exercises in our research facility.


Eligibility Criteria:
Inclusion Criteria:

* healthy
* male or female
* able to give written informed consent as documented by signature
* Aged: 18 to 40 years
* normotensive (BP 90/60mmHg to 140/90mmHg)
* BMI ≤ 30 kg/m2

Exclusion Criteria:

* bodyweight \<50 kg
* pregnant or lactating women
* intention to become pregnant during the course of the study
* known or suspected non-compliance, drug or alcohol abuse
* MADRS-S total score \> 12 or MADRS-S item 9 \>1
* inability to follow the procedures of the study, e.g. due to language problems, psychological disorders
* participation in another study with investigational drug within the 30 days preceding and during the present study
* participation in one of our previous studies using the same memory tests in the past 2 years or participation in our first luteolin study in 2020
* enrolment of the investigator, his/her family members, employees and other dependent persons
Trial to Evaluate the Efficacy of a Zinc, Selenium, and L-Tyrosine Supplement in the Prevention of Thyrotoxicosis in Subjects With r25191G/A SEPP1 Polymorphism

This randomized, double-blind, placebo-controlled trial evaluates the efficacy of a zinc, selenium, and L-tyrosine supplement in preventing thyrotoxicosis among adults aged 18-85 with elevated TPOAb levels and the r25191G/A SEPP1 polymorphism. The study excludes those with thyroid disease, pregnant/breastfeeding women, and individuals allergic to the supplement. Key endpoints include changes in thyroid antibodies and hormones over a 6-month period. With an estimated sample size of 150 participants per group, accounting for a 20% dropout rate, the trial seeks to demonstrate the supplement's potential in reducing thyrotoxicosis risk through a genetically-informed approach.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed presence of one or more specified gene polymorphism r25191G/A SEPP1
* TPOAb levels \> 300 IU/mL

Exclusion Criteria:

* Age \< 18 years and \>85
* Pregnant or breastfeeding woman
* Subjects with allergy to any of the supplementation component patients with any established diagnosis of thyroid disease
First-Line Treatment for Locally Advanced or Metastatic Mesenchymal Epithelial Transition Factor (MET) - Positive Gastric, Lower Esophageal, or Gastroesophageal Junction (GEJ) Adenocarcinoma

This is a phase 3, multicenter, randomized, double-blind, placebo controlled study of epirubicin, cisplatin \& capecitabine (ECX) with rilotumumab or placebo for untreated advanced MET-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma


Eligibility Criteria:
Key Inclusion Criteria:

* Pathologically confirmed unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma •Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1)
* Tumor MET-positive by immunohistochemistry (IHC)
* Evaluable (measurable or non-measurable) disease by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria

Key exclusion criteria:

* Human Epidermal Growth Factor Receptor 2 (HER2) -overexpressing locally advanced or metastatic gastric or GEJ adenocarcinoma •Previous systemic therapy for locally advanced or metastatic gastric or GEJ adenocarcinoma
* Less than 6 months have elapsed from completion of prior neoadjuvant or adjuvant chemotherapy or chemoradiotherapy to randomization
* Previous treatment with anthracyclines must not exceed total cumulative dose of epirubicin of 400 mg/m2
* Squamous cell histology
* Left ventricular ejection fraction (LVEF) \< 50%
Predictive Values of Serotonergic Alterations for Outcome - 2

The purpose of this study is to evaluate the predictive value of serotonergic alterations for outcome.


Eligibility Criteria:
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