cyrilzakka/clinical-trials huggingface dataset:
Perfusion and Hypoxia Evaluation in Tumors Using 18F-FDG PET/CT

Investigators want to use 18F-FDG PET/CT imaging to reflect tumor perfusion and hypoxia.

Perfusion and hypoxia were independent prognositic parameters for tumor patients. Developing a method that can evaluate tumor perfusion and hypoxia noninvasively and conveniently was in urgent need. 18F-FDG PET/CT imaging could reflect tumor hypoxia in 60min balanced imaging was proved and accepted. Moreover, FDG could diffuse out of the vasculature and through cell membranes passively and rapidly due to its lipophilicity, its regional uptake at initial times is expected to reflect tumor perfusion. So, investigators want to use 18F-FDG PET/CT imaging to evaluate tumor perfusion and hypoxia simutaniously，in order to guide the clinical diagnosis and treatment.

Eligibility Criteria:
Inclusion Criteria:

* 1.solid tumor proved by pathology(d\>3.0cm);
* 2.age\>18-year-old;
* 3. Karnofsky performance status \>70;
* 4.sign the informed consent.

Exclusion Criteria:

* 1.There are obvious metal implants near the tumor;
* 2.Can not lie still for 15 minutes.
* 3.Pregnancy.
Lovenox With Aspirin in Thawed Blastocyst Transfer

This prospective randomized trial will compare outcomes in patients receiving aspirin in combination with a low-molecular weight heparin and those under this center's standard protocol receiving neither medication, in order to determine if these medications may improve success rates.

This prospective randomized trial will compare outcomes in patients receiving aspirin (81mg daily) in combination with a low-molecular weight heparin (LMWH) (enoxaparin (Lovenox®), 40mg daily subcutaneous injection) and those under this center's standard protocol receiving neither medication, in order to determine if these medications may improve success rates.

Eligibility Criteria:
Inclusion Criteria:

1. Female patient 18-42 years of age with frozen embryos or oocytes seeking embryo transfer.
2. Use of pre-implantation genetically tested (PGT) blastocysts is allowed but not required.
3. Use of donated embryos or embryos derived from donated eggs is allowed.
4. Prior history of successful, failed, and/or canceled IVF cycles are allowed.

Exclusion Criteria:

1. Minor (age\<18 years).
2. Currently pregnant.
3. Unable to provide informed consent in English.
4. Gestational carrier or "surrogate".
5. Blastocysts frozen at another center (Oocytes frozen elsewhere is acceptable).
6. Subject intending or having "natural cycle" thaw transfer with an active ovarian follicle present.
7. Currently participating in any other research study.
8. Subject already had an embryo transfer under this study.
9. History of thrombocytopenia (reduced platelets), bleeding disorders, or routinely using anti-coagulant medication.
10. Hypersensitivity to aspirin, heparin, or benzyl alcohol.
11. Anyone for whom the physician assesses this protocol is inappropriate or unsafe.
Characterization, Risk Factors and Outcome of Neonates Admitted to Neonatal Intensive Care Units (NICU) at Sohag University Hospitals

The neonatal period considered the time from birth up to the first 28 days of life \& further classified into:

* Very early birth (birth to \< 24 hours).
* Early birth (24 hours to \< 7 days).
* Late or last neonatal period (7 days to 28 days).

It is characterized by the transition from extra uterine life and rapid growth and development. It is the common vulnerable time or period of human life as it accounts for more high mortalities and morbidities, however, most of them are preventable.

The pattern of neonatal disease is a useful indicator of the availability, utilization and effectiveness of maternal and child health care services.

It varies from place to place and from time to time even in the same locality. Information on admission and mortality patterns of hospitalized neonates should reflect the major causes of illnesses and standard of care provided to neonates in a particular locality.

To improve neonatal services with better overall outcomes and less sever morbidities early identification of the risk factors is paramount so that appropriate interventions can be directed towards the most prevalent and treatable neonatal illnesses. To achieve this goal, it is important to study the pattern of neonatal admissions


Eligibility Criteria:
Inclusion Criteria:

* All neonates that will be admitted in Neonatal Intensive Care Units (NICU) including preterm, term and post term neonates.

Exclusion Criteria:

* Failure to obtain consent.
* Neonates need preparation for advanced interventions not available in our unit like cardiac operations.
* Neonates require peritoneal dialysis.
* Traumatic injury.
Effects of Amino Acid Formulation on Healthy Men Undergoing Unilateral Knee Immobilization

This is a safety and tolerability study investigating the effect of an amino acid formulation in healthy volunteers during and after limb immobilization.


Eligibility Criteria:
Inclusion Criteria:

1. Generally healthy, non-smoking
2. Willing and able to provide informed consent
3. Men age 20-45 years
4. BMI between 25 and 35 kg/m2

Exclusion Criteria:

1. Smoker;
2. Subject has any concurrent medical, orthopedic, or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements;
3. History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years;
4. Significant orthopedic, cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder (requiring ongoing medical care), or metabolic/endocrine disorder (e.g., diabetes, high cholesterol, elevated fasting blood sugar) or other disease that would preclude oral protein supplement ingestion and/or assessment of safety and study objectives;
5. Any cachexia-related condition (e.g., relating to cancer, tuberculosis or human immunodeficiency virus infection and acquired immune deficiency syndrome) or any genetic muscle diseases or disorders;
6. Current illnesses which could interfere with the study (e.g. prolonged severe diarrhea, regurgitation, difficulty swallowing);
7. Subject participated in a study of an investigational product less than 60 days or 5 half-lives of the investigational product, whichever is longer, before enrollment in this study;
8. Hypersensitivity to any of the components of the test product;
9. Excessive alcohol consumption (\>21 units/week); (\> 21 standard drinks/wk); e.g., 18oz glass of 5% beer - 1.5 standard drinks, a 750 mL bottle of 12% wine = 5 standard drinks.
10. Known sensitivity or allergy to amino acids or any ingredient in the test formulations;
11. Prior gastrointestinal bypass surgery (Lapband, etc.), irritable bowel disease or irritable bowel syndrome;
12. History of bleeding diathesis, platelet or coagulation disorders, or antiplatelet/anticoagulation therapy (up to 81mg of baby aspirin per day taken as a prophylactic is permitted);
13. Personal or family history of clotting disorder or deep vein thrombosis. Deep vein thrombosis is a serious, and potentially lethal, medical condition, therefore, it is imperative if you have personal or family history it is disclosed this to the research staff.
14. Concomitant use of corticosteroids, testosterone replacement therapy (ingestion, injection, or transdermal), any anabolic steroid, creatine, whey protein supplements, casein or branched-chain amino acids (BCAAs) within 45 days prior to Screening;
15. Contraindications to an MRI scan (e.g. subjects with non-removable ferromagnetic implants, pacemakers, aneurysm clips or other foreign bodies, or subjects with claustrophobic symptoms that would contraindicate an MRI scan).
16. Hemoglobin \<11.5mg/dl at Screening;
17. Platelets \<150,000/uL (150x109/L) at Screening.
Safety of Short-term Hydroxychloroquine Plus Azithromycin Treatment in Critically Ill Patients With Severe COVID-19

Hydroxychloroquine and azithromycin have been proposed as treatment of COVID-19 patients, but few reports have assessed this combination therapy in critically ill COVID-19 patients.

Many raised concerns regarding the potential cardiac toxicity of this association.

The purpose of this monocenter retrospective observational study is to evaluate the safety of a short term treatment with hydroxychloroquine and azithromycin in critically ill patients admitted in ICU for severe COVID-19 with respiratory failure.

The main objective is to assess the incidence of severe cardiac arrhythmia e.g torsade de pointes and cardiac arrest or sudden death, during the treatment period.


Eligibility Criteria:
Inclusion Criteria:

* critically ill patients admitted in ICU for severe COVID-19 with respiratory failure for at least two days of treatment with hydroxychloroquine and azithromycin.

Exclusion Criteria:

* cardiac conduction disorders
* continuous anti-arrhythmic therapy
* heart failure
* chronic renal failure
Study of Screening Brain MRIs in Stage IV Breast Cancer

The study is a single arm, nonrandomized phase II prospective study, with the goal of investigating the role of screening brain MRIs in neurologically asymptomatic patients with metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of breast cancer with documentation of ER/PR/HER2 status
* Radiographic evidence of stage IV extracranial diease having progressed past first line therapy in HR+/HER2- patients
* Radiographic evidence of stage IV extracranial disease in TN and HER2+ patients
* Age ≥ 18
* Life expectancy ≥ 6 months
* Eastern Cooperative Oncology Group performance status 0 to 2
* Patients must be able to understand and the willingness to sign an informed consent for study procedures
* Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

* Prior diagnosis or treatment of brain metastases or leptomeningeal disease
* Patients with prior history of non-breast cancer malignancies should have no evidence of disease ≥ 2 years
* Neurologic symptoms warranting standard screening brain MRI in the judgement of the treating physician at time of enrollment
* Indications warranting brain MRI for other neurologic conditions at time of study entry
* Contraindication towards MRI imaging with contrast
* Chronic kidney disease stage IV or V or end stage renal disease
Local Tolerability and Safety of Povidone K25 Eye Drops (Artificial Tears Containing Povidone) Versus Placebo in Healthy Volunteers

Instillation of artificial tears is standard treatment in dry eye syndrome and in patients experiencing dry eye symptoms when wearing contact lenses. Povidone K25 eye drops (povidone) is an isotonic solution containing povidone to simulate normal tears viscosity. Safety and local tolerability of Povidone K25 is evaluated in healthy volunteers in comparison to placebo eye drops.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Older than 18 years
* Ocular discomfort less than 20 mm on 100 mm visual analogue scale (VAS) prior to treatment

Exclusion Criteria:

* Known hypersensitivity to any of the constituents of the medications
* Known allergic disposition (e.g. hay fever)
* Wearing of contact lenses
* Any kind of current eye disease (e.g. dry eye)

Additional exclusion criteria are defined in the protocol
Study on the Rule and Mechanism of Treating Functional Gastrointestinal Diseases From the Perspective of Liver and Spleen

To clarify the changes of intestinal flora - gut - brain axis in FGIDs patients represented by NERD disharmony of liver and stomach and IBS-D disharmony of liver and spleen, and confirm that the imbalance between intestinal flora and host co-metabolism is the key to the pathogenesis of functional gastrointestinal disease. To reveal the common mechanism of regulating liver and spleen (stomach) in treating FGIDs dynamic disorder and visceral hypersensitivity by regulating intestinal flora - intestine - brain axis disorder.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy volunteers with no abnormal clinical manifestations;
2. Meet the diagnostic criteria of NERD syndrome of disharmony of liver and stomach and IBS-D syndrome of liver depression and spleen deficiency.
3. Aged between 18 and 70.
4. Did not take antibiotics, steroids or other hormones, Chinese herbal preparations (including oral and intravenous administration), microecological preparations or probiotics such as yogurt for nearly a week;
5. Subjects are informed and sign informed consent voluntarily;
6. Have certain reading ability.

Exclusion Criteria:

1. Patients with severe lesions of the heart, liver, kidney and other major organs, hematopoietic system, nervous system or mental diseases;
2. Complicated with other organic diseases of the digestive system (such as peptic ulcer), or systemic diseases that affect the dynamics of the digestive tract (such as hyperthyroidism and diabetes);
3. Ongoing or ongoing use of drugs that may affect gastrointestinal function (antidiarrals, antidepressants, anti-anxiety drugs, intestinal microflora regulation drugs, antibiotics, etc.);
4. Those with a history of allergy to related drugs or severe food allergy used in the research.
5. The body is colonized with metal medical devices. (6) Having a pregnancy plan within three months.

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Randomized Placebo Controlled Trial of IVIg in Glycine Receptor Antibody Positive Stiff-person Syndrome

This is a randomized double-blind controlled trial of intravenous immunoglobulin (IVIg) for glycine receptor antibody positive (GlyRα1) antibody Stiff Person Syndrome (SPS) spectrum disorders. Adult patients will be enrolled over the course of 36 months. Study duration per patient will be 11 weeks. Total study duration will be 39 months. All treatment and study visits will occur at Mayo Clinic in Rochester, MN.

The purpose of this study is to determine whether intravenous immunoglobulin (IVIG) treatment reduces stiffness and spasms in patients with SPS spectrum disorders compared to patients who do not receive any treatment. In this study, investigators want to compare the effects, good and/or bad, of IVIG with placebo on participants with SPS to find out which is better. This is a "randomized, double-blind" study. Which treatment participants will receive is randomly determined. Participants have an equal chance of receiving IVIG or the placebo.

SPS spectrum cohort will include any from the SPS spectrum patient (stiff-limbs, stiff-trunk, stiff-limbs and trunk, and PERM). Study visits will be considered part of clinical care and will occur at: enrollment (will coincide with screening visit), and 11 weeks. IVIg/placebo (saline) treatments will be administered on 2 consecutive days in week 1, week 5, week 9 in all patients.

Eligibility Criteria:
Inclusion Criteria

* Patient must be 18 years of age or older
* Must have symptoms of SPS for less than 3 years
* If taking corticosteroids, the patients must be on a stabile dose for 30 days prior to enrolment
* Patients will have a diagnosis of SPS spectrum disorder based on both of clinical and serological status

Exclusion Criteria

* Patients on immune suppressants initiated/dose increased in the prior 6 months
* History of thrombotic episodes within the 2 years prior to enrollment
* Known allergic or other severe reactions to blood products including intolerability to previous IVIG
* Previous adequate trial of IVIG as determined by the Principal Investigator
* IgA deficiency
* Reproductive status:

  * Women who are pregnant, breastfeeding
  * Women and men of childbearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period, as evaluated by the investigator.
* Any surgical procedure within 4 weeks prior to baseline.
* Evidence of serious uncontrolled concomitant diseases that may preclude patient participation; Other nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency
* Known active infection within 4 weeks prior to baseline.
* Evidence of chronic active hepatitis B or C.
* Active ischemic heart disease in the past year prior to baseline.
* Patients should not have severe renal or hepatic disease
* Severe hypertension
Phase II Study of Bevacizumab, Capecitabine and Oxaliplatin in Colon Cancer

The purpose of this study is to determine the efficacy and safety of bevacizumab/capecitabine/oxaliplatin combination in metastatic or recurrent Korean colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented colorectal adenocarcinoma
* ECOG performance status of 2 or lower
* Adequate bone marrow function
* Adequate kidney function
* Adequate liver function
* Informed consent

Exclusion Criteria:

* Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start
* Known allergy to study drugs
Impact of Vitamin D Supplementation on COVID-19 Vaccine Response and IgG Antibodies in Deficient Women.

Decreased immunity in individuals causes a decrease in vaccine response, and vitamin D worsens this course. Vitamin D is thought to be a vitamin that can strengthen the innate immune response, inhibit the adaptive system, and modulate the vaccine response.

The effect of vitamin D intake on antibodies was studied.


Eligibility Criteria:
Inclusion Criteria:

* The study consisted of young volunteer women who completed 2 doses of COVID-19 vaccines, did not receive the 3rd dose, and spent an average of 65 days over the 2nd dose. Participants were included in the study when IgM value was negative, IgG value was positive, they were not older than 25 years, and serum 25-Hydroxy (25(OH)) vitamin D was below 30 ng/mL.

Exclusion Criteria:

* In addition, individuals participating in the research who were pregnant, had physician-diagnosed cardiovascular diseases, had kidney or liver failure, and had the chronic obstructive pulmonary disease were not included in the study.
Immediate Implant Placement With Immediate Loading With and Without Connective Tissue Graft

extraction of badely decayed anterior teeth immediate implant placement with immediate temporaization

Intra-operative procedure:

Local anesthesia will be injected intra-orally at the implant site. Atraumatic extraction of badley decayed teeth in the aesthetic area .

For group A :

traditional drilling for immediate implant placement . immediate temporization .

For group B :

traditional drilling for immediate implant placement . immediate temporization . subepithelial connective tissue graft from the palate .

Eligibility Criteria:
Inclusion Criteria:

* Patients with non-restorable maxillary anterior teeth indicated for implant placement.
* Both sexes.
* No intraoral soft and hard tissue pathology.
* No systemic condition that contraindicate implant placement.

Exclusion Criteria:

* Patients with systemic disease that may affect bone quality.
* Patients with poor oral hygiene and active periodontal diseases.
* Heavy smokers more than 20 cigarettes per day.
In Vitro Analysis of Human Urine With the CloudCath Device

This is a multi-center feasibility study to assess the in vitro function of the CloudCath Device that is being developed to derive clinically-relevant information from the optical characteristics of urine.

Specimens will be obtained from participants with indwelling catheters in hospital or home settings, who are suspected to be at high risk for urinary tract infection.

To evaluate the performance of the CloudCath Device in repeated measurements over time, multiple specimens may be obtained from the same patients over multiple days or months.

Each sample will be divided into multiple aliquots. One part will be analyzed using the CloudCath Device and reference devices. Another part may be submitted to an independent lab for standard analytical tests.

Eligibility Criteria:
Inclusion Criteria:

* provide a signed informed consent
* patient has an implanted urinary catheter (i.e., Foley, Texas, ureteral)

Exclusion Criteria:

* any condition that the investigator feels may confound the study results or place the participant at risk by participating in the study
* currently taking antibiotics for any reason other than for treatment of urinary tract infection (UTI)
* suprapubic bladder catheter implanted
Cybercycling for Cognitive Health

Exercise has been linked to cognitive health, but few older adults exercise at recommended levels. Cybercycling may provide additional cognitive benefits due to increased motivation to ride the interactive 3D tours. Participants will be randomly assigned to three months of either cybercycling or traditional stationary biking; and they will complete comprehensive evaluations before and after exercise. Older adults are expected to show significant neuropsychological, physiological and behavioral gains.

The purpose of this study is to test the following hypotheses: (1) stationary cycling with virtual reality tours ("cybercyle") will enhance executive function and clinical status more than traditional exercise; (2) exercise effort will explain improvement; and (3) brain-derived neurotrophic growth factor (BDNF) will increase.

Eligibility Criteria:
Inclusion Criteria:

* age 50+
* able to participate in cycling
* physician permission

Exclusion Criteria:

* unstable heart condition
* physician denial
* neurological condition
Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries

To compare intraoperative and immediate postoperative outcomes of mini-sternotomy versus mini-thoracotomy as less invasive techniques in patients with isolated aortic valvular and subvalvular disease requiring surgery according to inclusion criteria.

1. It has been demonstrated that minimally invasive aortic valve replacement (MIAVR) approaches are safe and effective for the treatment of aortic valve diseases. To date, the main advantage of these approaches is represented by the reduced surgical trauma, with a subsequent reduced complication rate and faster recovery. This makes such approaches an appealing choice also for frail patients \[obese, aged, chronic obstructive pulmonary disease (COPD)(1).
2. Minimally invasive aortic valve replacement (MIAVR) has been increasingly accepted in the surgical community as a potential alternative to conventional sternotomy, with advantages of reduced trauma, improved cosmotic and reduced hospitalization(2).
3. The Mini sternotomy (MS) approach represents the most common technique used for Minimally invasive AVR. The MS approach is achieved through 6 to 10cm midline vertical skin incision, performing a partial J sternotomy at the third to fifth intercostal space (3). MIAVR via right mini thoracotomy (RT) is performed through five to seven cm skin incision placed at the level of the second intercostal space without rib resection. After sacrificing the right internal thoracic artery(4).
4. Despite these excellent results, there have been an increasing number of cases performed via minimally invasive aortic valve replacement (MIAVR). This approach has now become an established alternative to FS in order to reduce the "invasiveness" of the surgical procedure, while maintaining the same efficacy, quality and safety of a conventional approach (5).

Eligibility Criteria:
Inclusion Criteria:

1. Patients with isolated Aortic valve and subvalvular disease.
2. sexes included with acceptance of patients to participate in this study and approval of Ethical Committee.

Exclusion Criteria:

1. Patients ages who less than 16 yrs and more than 60yrs.
2. Emergent open heart surgery.
3. Patients with current Infective endocarditis.
4. Patients with chest deformity pectus excavatum or carinatum due to difficult access.
5. The patient refused to sign the informed consent to participate in the research.
6. Patients with Aortic root abscess or Aortic dilatation at root or ascending parts.