cyrilzakka/clinical-trials huggingface dataset:
Enzalutamide Treatment in COVID-19

COVID-19 is a disease with high rate of morbidity if symptomatic. There is a great need of treatments to decrease the severity. The vast majority of patients needing intensive care are men, and this may be due to the androgens, either by regulation of TMPRSS2, necessary for virus internalization, or other mechanisms. Enzalutamide is an antiandrogen inhibiting the expression of androgen regulated proteins, such as TMPRSS2. The aim of this trial is to evaluate a possible beneficial effect of short-term enzalutamide treatment of COVID-19 patients.


Eligibility Criteria:
Inclusion Criteria:

* Positive COVID-19 test
* Mild to severe symptoms of COVID-19
* Hospitalization
* WHO performance status 0-3
* Age above or equal to 50 years
* Can understand all the requirements of the study, provide informed consent, and provide authorization of use and disclosure of personal health information.
* Estimated expected survival of 1 year (excluding symptoms due to COVID-19)

Exclusion Criteria:

* Severe allergy to Enzalutamide
* Pregnant or breast-feeding women
* Need of immediate mechanical ventilation
* Current medication includes enzalutamide treatment
* Stroke or Transitory Ischemic attack in medical history
* Treatment for HIV
* Treatment with tamoxifen
* Treatment with immunosuppressive agents
* Severe immunosuppressive disease
* Treatment with warfarin or NOAC (Non-vitamin K-antagonist anticoagulants)
* Previous seizure in medical history
* Other serious illness or medical condition
* Unstable cardiovascular disease
Network Pharmacology Prediction: Mechanism Study of Puerarin in the Treatment of Giant Cell Tumors of Bone

Based on network pharmacology analysis, this study aims to explore the potential therapeutic targets and molecular mechanisms of puerarin on giant cell tumor of bone (GCTB) genes.

The giant cell tumor of bone's pathological genes were discovered from DisGeNET and GeneCards databases. The therapeutic genes of puerarin were gathered from Swiss Target Prediction, CTD(Comparative Toxicogenomics Database), PharmMapper, and TCMSP databases (Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform). Cytoscape software was used with the MCODE algorithm to calculate key potential therapeutic targets of puerarin against GCTB. The bulk RNA-seq datasets (GSE102193) were used to identify differential expression of potential therapeutic genes. The sc RNA-seq (GSE168664) was utilized to determine the expression distribution of different cell clusters. Essential targets of puerarin against GCTB underwent function and pathway enrichment assays to elucidate biological processes and signaling pathways. Furthermore, the investigators conducted a comparison to determine if the primary biological processes and pathways following denosumab treatment exhibit resemblances to the potential mechanisms of puerarin action. Molecular docking and dynamics simulation were conducted to evaluate interactions between selected potential therapeutic targets and puerarin. Immunohistochemical (IHC) and immunofluorescence (IF) staining were performed to identify the expression of crucial markers in human GCTB tissue. Expression levels of pivotal genes in primary BMSC cells and primary GCTB cells and their alteration following puerarin treatment in primary GCTB cells were evaluated.The significance of differences between groups was estimated by the Student t-test or Wilcoxon test. In all the statistical analyses, data with two-tailed p \< 0.05 were considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed as a patient with giant cell tumor of bone;
2. Performing surgical treatment in 1st hospital of SYSU;
3. Having complete clinical registration information;
4. Preserve surgical or puncture specimens;

Exclusion Criteria:

1. Non bone giant cell tumor patients;
2. No surgical treatment was performed;
3. Incomplete clinical information registration;
4. No preserved surgical or puncture specimens.
Total-body PET / CT in the Evaluation of Treatment and Prognosis of Lymphoma

The prospective study aims to explore the value of total-body PET/CT dynamic imaging (uExplorer) in assessing the treatments and prognosis in patients affected with lymphoma. Total-body 18F-FDG PET/CT scans are being performed before treatment, after three cycles of chemotherapy and six weeks after the end of treatment. The plan of this study involves to evaluate the clinical application of total-body PET / CT in patients histopathologically-diagnosed as lymphoma, and to optimize the dynamic acquisition protocols with total-body 18F-FDG PET/CT.

100 cases of lymphoma patients are enrolled in this study. Participation in this study involves three dynamic 18F-FDG PET/CT exams, which occur before the treatments start, two or three days before the fourth cycle of chemotherapy, and then six weeks after the end of last treatments. Progress Free Survival(PFS) and Overall Survival(OS) are used as the end points to study the value of metabolic parameters obtained from the dynamic PET/CT imaging. The differences of dynamic metabolic parameters and static SUV value are evaluated in patients with lymphoma from the perspective of diagnosis, staging, treatment and prognosis.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed, written and dated informed consent prior to any study specific procedures
* Had histologically confirmed lymphoma
* Patients aged 18\~75 years old

Exclusion Criteria:

* Female patients who are pregnant, breast-feeding
* Currently active second malignancy other than Lymphoma
* Any situation not suitable for this study judged by researchers
Effect of Changing Levels of Neurally Adjusted Ventilatory Assist (NAVA) in Newborns

To examine the effect of changing levels of support during NAVA-ventilation ("NAVA-level") on electrical diaphragm activity of the newborn on invasive or non-invasive NAVA ventilation.

The aim is to explore whether a so-called 'breakpoint', as defined in previous studies on NAVA ventilation in adults and children(1, 9), can be determined in newborn infants. Knowledge of this breakpoint will be used to optimise the settings of NAVA level at initiation of invasive or non-invasive NAVA ventilation.

This is an explorative study conducted in preparation of a randomized controlled trial that is planned in the near future to compare the effects of non-invasive NAVA with nasal continuous positive airway pressure (CPAP) in newborn infants.


Eligibility Criteria:
Inclusion Criteria:

* Newborns admitted to the NICU in need for respiratory support and put on invasive or non-invasive NAVA by the attending physician. Patients will be included when they are clinically stable and within 24h after starting NAVA or nivNAVA.

Exclusion Criteria:

* - Congenital malformations of the diaphragm or respiratory system, including congenital diaphragmatic hernia.
* Patients with abnormalities of the upper airway (e.g. vocal cord paralysis, post-extubation laryngeal edema, Pierre-Robin sequence...).
* More than 20% of time spent in back-up ventilationWhen a patient on NAVA ventilation is apneic for a certain period of time (apnea time), the ventilator switches tot backup-ventilation. Backup-ventilation is pressure controlled, the apnea time can variate between 2 and 10 seconds.
* Clinically unstable patients:
* hemodynamic instability as defined by need of inotropic support or
* rapid respiratory deterioration on NAVA ventilation.
* No informed consent.
Acute Effect of HMG-CoA Reductase Inhibition (Atorvastatin)on Renal Hemodynamics, Tubular Function and Vasoactive Hormones on Healthy Subjects

We wanted to test the acute effect of HMG-CoA reductase inhibition (atorvastatin) on renal hemodynamics, renal tubular function and vasoactive hormones on healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Both men and women
* Age: Between 20-50
* BMI\<30

Exclusion Criteria:

* Clinical signs or history of disease of heart, lungs, kidneys or endocrine organs.
* Abnormal lab. tests( haemoglobin, pl. sodium, pl. potassium, pl.creatinine, pl.bilirubin, pl.ALAT, pl. cholesterol, blood glucose)
* Albuminuria or glucosuria
* Cancer
* Art. hypertension
* Alcohol abuse
* Medical treatment, except oral contraceptives
* Pregnancy or breast feeding
* Blood donation less than 1 month before study
Twitter Based Social Support for Hispanic and Black Dementia Caregivers

The prevalence of dementia is higher in Hispanics and African Americans than non-Hispanic Whites. Moreover, dementia caregivers often experience loneliness as well decreased health status. The expansion of social media use among Hispanics and African Americans, particularly Twitter - a short message service - offers great promise for improving social support. This study aims to evaluate changes of discussion topics, sentiment and networking styles (i.e., number of followers) among anonymous followers of our two Twitter networks; the African American/Black dementia caregiver group and the Hispanic dementia caregiver group.

The study will utilize Twitter networks to post a daily message for dementia caregivers for a year, and set up a monthly group chat.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Black or Hispanic, living in the U.S. including the U.S. territories
* a dementia caregiver with any duration, able to speak English or Spanish/bilingual
* must agree to terms of conditions of use and privacy policy and rules of one of the two dementia caregiver network (Hispanic @dcnh, Black @dcnaab), the Twitter user agreement of the terms of service, Twitter privacy policy and Twitter rules including intellectual property, violence, misconduct, abuse behavior, private information and spam and security
* use a smartphone or a feature phone (i.e., a cell phone with text messaging)

Exclusion Criteria:

* do not have de-identified Twitter account, children, not a dementia family caregiver
Aerobic Exercise to Improve Memory in TBI

Aerobic exercise holds a multitude of health benefits. Studies in mice have shown that aerobic exercise improves memory, and increases the volume of the hippocampus, the brain's primary memory center. Only two studies have been conducted in humans, one in healthy elders, and the other in a schizophrenia population. So far, there has never been an aerobic exercise trial in traumatic brain injury (TBI) to look at hippocampal volume and memory as outcomes of interest. The proposed project is a randomized controlled trial of aerobic exercise in persons with TBI. We will conduct a 12-week (36 sessions) program of aerobic exercise (stationary cycling), versus a control condition of non-aerobic exercise (stretching), in memory-impaired TBI patients to a) increase hippocampal volume and b) improve memory. Importantly, we also expect benefits of aerobic exercise on the level of brain function. Specifically, we will look at 'functional connectivity,' which refers to how efficiently remote regions of the brain 'talk' to each other. TBI is an ideal population to benefit from aerobic exercise, given the young age at which many individuals sustain TBI, which allows for benefits of aerobic exercise to be maximally realized in a population with sufficient neurofunctional reserve. The expected benefits of aerobic exercise (increased hippocampal volume, improved memory) from this intervention stand to have a meaningful impact on people with TBI, including improved health, productivity, independence, and quality of life. And, unlike current treatments for memory impairment (e.g., pharmacological agents, cognitive rehabilitation), aerobic exercise is a cost-effective, all natural, readily-available treatment for memory problems.


Eligibility Criteria:
Inclusion Criteria:

* TBI greater than or equal to 1 year
* MRI compatibility
* Right Handed

Exclusion Criteria:

* Reported lower body weakness or use of an assistive device for walking
* History of pulmonary disease, heart disease, vascular disease of the legs, high blood pressure
* History of stroke, other neurological disease/disorder, serious psychiatric illness
* Engaging in more than 30 minutes of aerobic exercise per week
* Current use of steroids, benzodiazepines, and/or neuroleptics
* History of substance abuse
Optimizing Nutrition and Milk (Opti-NuM) Project

Early nutrition critically influences growth, neurodevelopment and morbidity among infants born of very low birth weight (VLBW), but current one-size-fits-all feeding regimes do not optimally support these vulnerable infants. There is increasing interest in "precision nutrition" approaches, but it is unclear which Human Milk (HM) components require personalized adjustment of doses. Previous efforts have focused on macronutrients, but HM also contains essential micronutrients as well as non-nutrient bioactive components that shape the gut microbiome. Further, it is unclear if or how parental factors (e.g. body mass index, diet) and infant factors (e.g. genetics, gut microbiota, sex, acuity) influence relationships between early nutrition and growth, neurodevelopment and morbidity. Understanding these complex relationships is paramount to developing effective personalized HM feeding strategies for VLBW infants. This is the overarching goal of the proposed Optimizing Nutrition and Milk (Opti-NuM) Project.

The Opti-NuM Project brings together two established research platforms with complementary expertise and resources: 1) the MaxiMoM Program\* with its clinically embedded translational neonatal feeding trial network in Toronto (Dr. Deborah O'Connor, Dr. Sharon Unger) and 2) the International Milk Composition (IMiC) Consortium, a world-renowned multidisciplinary network of HM researchers and data scientists collaborating to understand how the myriad of HM components contribute "as a whole" to infant growth and development, using systems biology and machine learning approaches. Members of the IMiC Corsortium that will work with on this study are located at the University of Manitoba (Dr. Meghan Azad), University of California (Dr. Lars Bode) and Stanford (Dr. Nima Aghaeepour).

Observational study mode:

The Opti-NuM Project is a retrospective secondary data/sample use study.

Time perspective:

Secondary use data and biospecimens accruing from the 2 completed studies DoMINO and OptiMOM (NCT02137473) and 1 ongoing RCT MaxiMoM (NCT05308134) are included in this project.

Sampling method:

This project is a secondary use of data/samples, from a cohort consisting of participants of the MaxiMoM Platform RCTs.

Eligibility Criteria:
Inclusion Criteria:

• Secondary data and biospecimens from participants of the MaxiMoM Platform RCTs

Exclusion Criteria:

• Data and biospecimens from infants who are not enrolled in the three trials are eligible for this project.
Stone Clearance in Patients With Upper Ureteric Stones Using Extracorporeal Shock Wave Lithotripsy Compared With Extracorporeal Shock Wave Lithotripsy Combined With Tamsulosin Therapy

Extracorporeal shock wave lithotripsy (ESWL) is the least invasive and effective treatment for upper ureteric stones with a stone clearance rate of 60-90%. Tamsulosin is an alpha-blocker widely used in urological practice to relax smooth muscle of the prostate and bladder neck. Its role as part of medical expulsion therapy for the treatment of patients with kidney and ureteric stones has proved to be of considerable success. However, its role in clearing upper ureteric stones as an adjunct to ESWL is controversial. Therefore, this study will be conducted to evaluate its role in stone clearance along with extracorporeal shock wave lithotripsy in patients with upper ureteric stones


Eligibility Criteria:
Inclusion Criteria:

* single upper ureteric stone
* size ranging from 6-15 mm
* stones history less than 6 months

Exclusion Criteria:

* Patients with urinary tract infection
* multiple ureteric stones,
* presence of a ureteric stricture distal to the stone,
* previous unsuccessful ESWL,
* concomitant use of calcium channel blockers or alpha-adrenergic antagonists
* patients with abnormal coagulation profile
The Pilot Clinical Study of PG2 Injection on Hemorrhagic Stroke

Astragalus membranaceus (AM) is used to treat stroke for a long time, and a number of studies have shown that AM can reduce cerebral infarction area and has anti-oxidation activity. PG2, a sterile powder of polysaccharides isolated from the root of astragulus (Huang-Chi) for intravenous injection, has been approved as a botanical drug by TFDA. Hemorrhagic stroke will induce secondary peri-blood clot edema and that may increase intracranial pressure to exacerbate clinical symptom. Therefore, the purpose of the present study was to investigate the efficacy of PG2 on hemorrhagic stroke.

This will be a double-blind, randomized, placebo-controlled study. An estimated 60 (at least 48 evaluable) first hemorrhagic stroke patients will be randomly divided into the control and treatment groups. Each group will be treated as follows: 1) control group will accept placebo t.i.w treatment for 14 days from second day of admission, in addition to standard ordinary treatment.; 2) treatment group will accept PG2 t.i.w treatment for 14 days from second day of admission, in addition to standard ordinary treatment. Inflammatory index including the levels of C-Reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), S-100 protein, IL-1, IL-6, and TNF-beta levels will be measured and clinical symptoms including Glasgow outcome scale (GOS), modified rankin scale (MRS), Functional Independence Measure (FIM) and Barthel Index (BI) will be evaluated during this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients who confirmed diagnosis of first spontaneous hemorrhagic stroke
* Patients with hemorrhagic stroke in Putamen
* Patients who admitted to the hospital within 24 hours of onset of hemorrhagic stroke
* Patients who signed the informed consent form

Exclusion Criteria:

* Patient with hemorrhage in the area out of Putamen or primary subarachnoid hemorrhage, Arteriovenous malformation (AVM) or brain tumor hemorrhage
* Patient who performed craniotomy
* Patient who suffering from cirrhosis, uremia with dialysis, bleeding tendency, severe cardiopulmonary disease or mental disorders would be unable to comply with the study by investigators' decision.
* Patients have enrolled or have not yet completed other investigational drug trials within 1 month before screening.
* Female patients are pregnant or breast-feeding.
Clinical Effect of Phenytoin Mucoadhesive Paste on Wound Healing After Oral Biopsy

several studies have investigated healing effect of phenytoin.In this study we investigate healing effect of phenytoin mucoadhesive paste comparing to the usual mucoadhesive paste after oral biopsy.


Eligibility Criteria:
Inclusion Criteria:

* patients undergone oral biopsy

Exclusion Criteria:

* systemic disease
A New Revolutionary 3-Injection- Protocol in Infertile Women

This is a prospective randomised study of the evaluation of the clinical IVF results after following a new revolutionary 3-Injection- Protocol for controlled ovarian stimulation in infertile women.

A randomized prospective study focusing on infertile women undergoing ovarian stimulation for IVF, using Elonva (corifollitropin alfa) as part of two different stimulation protocols.

Women assigned to Protocol A receive a bolus late luteal dose of Degarelix, a new long acting GnRH antagonist, a sole Elonva injection in the evening of day 3 of the cycle, followed by the administration of a single dose of triggering agent (GnRH agonist or hCG a, according to the individual response).

Women assigned to Protocol B are administered a single dose of Elonva (corifollitropin alfa) on day 2 of the cycle, followed by daily GnRH antagonist doses, fixed on day 7 of the cycle. Ovulation triggering is the same as in group A, with either GnRH agonist or hCG a, accordingly.

Live Birth Rates are estimated for both groups of patients. The number of the formed blastocysts in each group is measured, as well.

Eligibility Criteria:
Inclusion Criteria:

* primary infertility
* age 22-39 years;
* body mass index (BMI) 18-29kg/m2;
* regular menstrual cycle of 26-35 days,
* presumed to be ovulatory;
* early follicular- phase serum concentration of FSH within normal limits (1-12 IU/l).

Exclusion Criteria:

* women with diabetes and other metabolic disease
* women with heart disease, QT prolongation, heart failure
* elevated liver enzymes, liver failure, hepatitis
* women with inflammatory or autoimmune disease
* abnormal karyotype
* polycystic ovarian syndrome
* endometriosis stage III/IV
Animal Assisted Therapy in Dentistry

A cross-sectional prospective study measuring physiologic biometrics and perceptions of stress during a dental procedure with or without a therapy dog present.

Patients will be consented, enrolled, and assigned to a control group (no dog) or to an experimental group (dog). The patient assigned to the experimental group will be exposed to the therapy animal prior to the dental appointment. Pre-dental procedure and post-dental procedure surveys will be given to all the subjects asking the same questions. Biometric data will be collected by measuring heart rates of the patient/subject during the dental appointment with a Shimmer or Polar device.

Eligibility Criteria:
Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:

* 7-17 years of age
* Patient undergoing 1 quadrant restorative dental procedure requiring a handpiece (e.g. multiple fillings, sealants and/or stainless-steel crowns) and/or extraction(s)
* History of moderate dental anxiety with a Frankl score of 2-3 based on Epic chart review

Exclusion Criteria Subjects presenting with any of the following will not be included in the study:

* Patients with developmental delay/special needs, Autism Spectrum Disorders (ASDs), craniofacial defects, chronic pain conditions, and/or dental syndromes
* No history of dental anxiety
* Moderate to severe allergy to dogs
* Previous traumatic experience with a dog and/or self-reported fear of dogs
* Patients who are not receiving dental care requiring a handpiece (for ex, prophylaxis only)
* Patients with severe, documented xerostomia
* Patients receiving sedation (pharmacological and conscious sedation) or general anesthesia
* Patients who will have physical restraints placed during the dental procedure
* Patient scheduled to have sedation or general anesthesia
* Severe acute or chronic medical or psychiatric condition(s) that would interfere with the interpretation of results, and in the judgement of the Investigator, would make the subject inappropriate for entry into the trial
* Patient with developmental/cognitive disability that cannot self-assent, comprehend and follow the requirements of the study based on research site personnel's assessment.
* Inability or unwillingness of individual and legal guardian/representative to give written informed assent (from child) and consent (from adult).