cyrilzakka/clinical-trials huggingface dataset:
Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of TG-0054 With Single IV Doses Escalation in Healthy Volunteers

TG-0054 is a CXCR4 antagonist with stem cell mobilization effect as proven in animal model, this is the fist in human study to investigator the safety, tolerability and PK/PD in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female 18 to 45 years of age inclusive
* Body mass index (BMI) in the range of 19.0 to 30.0 kg/m² and body weight ≥ 50 kg inclusive
* Good physical and mental health status determined on the basis of the medical history and a general clinical examination
* Subjects must have used a consistent form of acceptable oral birth control or the double barrier method (intrauterine device (IUD) plus condom, spermicidal gel plus condom) for at least 3 months prior to study initiation

Exclusion Criteria:

* Any medical condition (other than a self-limited illness) that requires ongoing and current medical attention
* History of any other hematologic disorders including thromboembolic disease or anemia
* Severe trauma, fracture, major surgery, or biopsy of a parenchymal organ within the past 3 months
* Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
* Subjects who currently smoke (intake nicotine or nicotine-containing products) or have given up smoking for less than 6 months before the first administration of study drug
* Subjects who are carriers of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody or who are Human Immunodeficiency Virus (HIV) antibody positive
Ultrasonographical of Suprarenal Gland in High Risk Neonates

Observation study The aim is to study the suprarenal blood flow among high-risk neonates and its relation to the risk factors

Ultrasonographical study of the suprarenal gland in high risk newborn infants Al-Zhrraa University hospital Sample size 105 Inclusion criteria: 1- High-risk newborn 2- Need NICU admission Exclusion criteria: Cases with Major congenital anomalies and NEC Primary outcome: Abnormal suprarenal blood flow Informed consent will be obtained from all parents and mothers of the newborns enrolled in the study.

All cases will be subjected to - Full history taking: (prenatal -natal - postnatal). According to the routine admission sheet of NICU of Alzahraa University Hospital, Faculty of Medicine for girls, AL-Azhar University, Cairo, Egypt.

Through clinical examination (APGAR score -estimation of gestational age using modified Ballard score \&#34;Ballard, 1991\&#34; - body weight - severity of respiratory illness using Downs score and Silverman\&#39;s score).

Laboratory investigations:

* Blood gases.
* Serum electrolytes and blood glucose.
* CBC. CRP.
* Liver and kidney functions. Radiological evaluation: in the form of Abdominal and chest x-ray. Ultrasonographical studies were done for suprarenal gland blood flow. - Statistical Analysis, Data were collected, revised, coded, and entered into the statistical package for social science (SPSS)

Eligibility Criteria:
Inclusion Criteria:

* High risk neonates

Exclusion Criteria:

* congenital anomalies
Oral Administration of Colostrum to Premature Babies: Impact on the Oral Microbiota

Oropharyngeal administration of mother's colostrum to premature infants has been proposed as a stimulus to the oropharyngeal lymphatic tissues to decrease the incidence of pneumonia and sepsis, particularly in intubated babies. We propose to study the impact of this intervention on the composition of the oral microbiota.


Eligibility Criteria:
Inclusion Criteria:

* premature infant with birth weight \< 1500
* intubated in the first 48 hours of life
* available maternal colostrum

Exclusion Criteria:

* lethal condition
Antibiotic Prophylaxis for PEG in Children

The aim of this study is to evaluate if a single i.v. dose of co-amoxiclav before PEG can reduce the incidence of peristomal wound infection in the paediatric population.

Percutaneous Endoscopic Gastrostomy (PEG) is a common endoscopic procedure, performed to avoid malnutrition in various pathological conditions.

Gastrostomy tube placement is associated with intra and postoperative complications both in the adult and in the paediatric population.

Local infection is the most common complication following PEG.

Antibiotic prophylaxis is a well-established strategy to reduce peristomal wound infection rate in adult population.

The aim of this study is to evaluate if a single i.v. dose of co-amoxiclav before PEG can reduce the incidence of peristomal wound infection in the paediatric population.

Eligibility Criteria:
Inclusion Criteria:

* All pediatric patients (0-18 years) who will refer for PEG placement to the endoscopy unit

Exclusion Criteria:

* Controindications for PEG
* Ongoing antibiotic treatment
* Antibiotic use within the past 4 days
* Illness too severe to allow the patient to participate
* Allergy to penicillin
Trial of Docetaxel Versus Vinorelbine as 1st Line Treatment in Elderly Patients With Non-Small-Cell Lung Cancer (NSCLC)

This trial will compare the efficacy of docetaxel versus vinorelbine as first-line treatment in elderly patients with advanced NSCLC.

Docetaxel and vinorelbine are well known active agents in the treatment of NSCLC. The standard treatment of elderly patients with advanced NSCLC is monotherapy with a third generation agent. The role of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation.

Eligibility Criteria:
Inclusion Criteria:

* Histologically- or cytologically- confirmed Non-Small-Cell Lung Cancer
* Stage IIIB/IV
* No prior chemotherapy
* Existence of two-dimensional measurable disease. The measurable disease should not have been irradiated
* Life expectancy of more than 3 months
* Age ≥ 65 years
* Performance status (WHO) ≤ 3
* Adequate bone marrow function (absolute neutrophil count \> 1000/mm\^3, platelet count \> 100000/mm\^3, Hemoglobin \> 9 gr/mm\^3)
* Adequate liver (bilirubin \< 1.5 times upper limit of normal and SGOT/SGPT \< 2 times upper limit of normal), and renal function (creatinine \< 2 mg/dl)
* Informed consent

Exclusion Criteria:

* Psychiatric illness or social situation that would preclude study compliance.
* Other concurrent uncontrolled illness
* Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
* No absence or irradiated and stable central nervous system metastatic disease.
* No presence of a reliable care giver
* Other concurrent investigational agents
For Patients with Stones in Gallbladder and Bile Duct Stones At the Same Time, Surgical Removal of the Gallbladder with the Laparoscope is Done in the Same Admission Compared to Its Removal After 6 Weeks Following Successful Removel of the Stones from the Bile Ducts by the Side View Endoscope

The goal of this clinical trial is to learn if early laparoscopic cholecystectomy is safe and feasible when performed during the same admission for patients with concomitant gallbladder and common bile duct stones after clearance of CBD stones via ERCP in comparison to Late laparoscopic cholecystectomy 6 weeks after ERCP. The main questions it aims to answer are: laparoscopic cholecystectomy

* Does index laparoscopic cholecystectomy associate with less recurrence of biliary complications?
* Is index laparoscopic cholecystectomy feasible and safe for the patients in terms of intraoperative difficulties, conversion to open, hospital stay, and postoperative complications than late laparoscopic cholecystectomy? the investigator will compare index laparoscopic cholecystectomy with late laparoscopic cholecystectomy 6 weeks after ERCP to see if index laparoscopic cholecystectomy is safe and feasible and associated with better outcomes.

Participants will:

Come to the outpatient clinic every week after intervention for follow-up for 3 months after surgery.

The study population of this randomized controlled trial study is those who underwent CBD stone clearance by ERCP. The included fifty patients were stratified randomly into two groups: early and delayed.

Randomization was done using computer-generated random number sequences in concealed envelopes with a block randomization design. Laparoscopic cholecystectomy is performed on the next day after successful clearance of stones from CBD while, the patient is still admitted, for the early group and postponed 4 to 6 weeks for the delayed group after the patient is discharged home.

Laparoscopic cholecystectomy was performed by the same surgical team for both groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients with concomitant gallbladder and common bile duct stone who underwent clearance of common bile duct stones by ERCP

Exclusion Criteria: patients with any of the following:

* Severe pancreatitis
* Suspicion of post-ERCP bleeding or perforation,
* Associated malignancy
* Those in whom ERCP failed to clear the CBD stones
NEURESCUE Device as an Adjunct to Cardiac Arrest

The NEURESCUE device is the first intelligent balloon catheter for aortic occlusion, an emergency technique that supercharges blood flow to the heart and brain within one minute from deployment.

The catheter-based device is delivered via the femoral artery, temporarily inflating a soft balloon in the descending to redirect blood flow towards the upper body.

The objective of the study is to investigate the safety and performance of the NEURESCUE device as an adjunct to Advanced Life Support (ALS) in adults with cardiac arrest.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 and ≤79 years
2. Witnessed cardiac arrest
3. CPR initiated within 7 min of presumed arrest
4. Cardiac arrest not responding to standard ALS
5. Total CPR time ≤ 40 min at the time of screening for enrollment

Exclusion Criteria:

1. Traumatic cardiac arrest
2. Known pregnancy
3. Known terminal disease
4. Known Do-Not-Resuscitate (DNR) order
5. Subjects whose femoral arterial access site cannot accommodate an 8 Fr introducer sheath
6. Subjects currently on mechanical circulatory support
A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer

The purpose of this study is to learn about the effects of three study medicines (encorafenib, cetuximab, and pembrolizumab) given together for the treatment of colorectal cancer that:

* is metastatic (spread to other parts of the body);
* has the condition of genetic hypermutability (tendency to mutation) or impaired DNA mismatch repair (MMR)
* has a certain type of abnormal gene called "BRAF" and;
* has not received prior treatment.

All participants in this study will receive pembrolizumab at the study clinic as an intravenous (IV) infusion (given directly into a vein) at the study clinic.

In addition, half of the participants will take encorafenib by mouth at home every day and cetuximab by IV infusion at the study clinic.

The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.


Eligibility Criteria:
Inclusion Criteria:

* Locally confirmed microsatellite instability-high/ deficient mismatch repair (MSI-H/dMMR) stage IV colorectal carcinoma
* Locally confirmed BRAF V600E mutation in tumor tissue or blood
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Have not received prior systemic regimens for metastatic disease.
* Measurable disease per RECIST 1.1
* Adequate organ function

Exclusion Criteria:

* Colorectal adenocarcinoma that is RAS mutant or for which RAS mutation status is unknown
* Known active central nervous system metastases and/or carcinomatous meningitis; leptomeningeal disease
* Immunodeficiency or active autoimmune disease requiring systemic treatment in the past 2 years
* Presence of acute or chronic pancreatitis
* Clinically significant cardiovascular diseases (eg, thromboembolic or cerebrovascular accident events ≤ 12 wks prior)
* Received a live or live-attenuated vaccine within 30 days of planned start of study medication
* Previous treatment with any selective BRAF inhibitor (eg, encorafenib, dabrafenib, vemurafenib, XL281/BMS-908662) or any epidermal growth factor receptor (EGFR) inhibitor (eg, cetuximab, panitumumab).
* Previous treatment with an immune checkpoint inhibitor (eg, anti-programmed cell death \[PD-1\], anti-PD-L1 or anti-PD-L2 agent); or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
The Effect of Triflusal on Peripheral Microcirculation Dysfunction

To explore the efficacy of triflusal in patients with symptomatic peripheral microcirculation dysfunction. Triflusal is a salicylate compound approved in several countries as antithrombotic agent and it additionally has vasodilatory effect. The hypothesis is to explore if there is a improvement of peripheral microcirculation by triflusal.


Eligibility Criteria:
Inclusion Criteria:

* Between 40 and 70 years of age
* Diagnosed vasospastic syndrome with nailfold capillaroscopy (Fingertip is subjected to carbon dioxide at -15°C for 60 seconds. People found to have a blood-flow standstill of at least 12s in one or more capillaries were defined as having vasospasticity)
* More than seven points in 10-question interview provided by Nagashima et al.
* Written informed consent

Exclusion Criteria:

* Prior documented diabetes
* Overt peripheral artery disease
* Pregnant or nursing
* bleeding tendency
* Any contraindication of antiplatelet agent
* Thrombocytopenia (platelet \< 100,000mm3)
* Chronic liver disease (ALT \> 100 IU/L or AST \> 100 IU/L) or renal dysfunction (creatinine \> 4.0 mg/dl)
* Patients who can not stop to take aspirin
Study IL- 35 Level and Fibronectin Type Ⅲ Domain Containing Protein 5 \ Irsin (FNDC5 rs3480) Gene Variations in Chronic Hepatitis B.

Find a possible association between Fibronectin type Ⅲ domain containing protein 5 \\ Irsin (FNDC5 rs3480) gene single nucleotide polymorphism with chronic hepatitis B and the distribution of its alleles, in relation to many clinical parameters of the chronic hepatitis B group.

* Asses the correlation between IL-35 serum level and the risk of chronic hepatitis B.
* Asses the correlation between SOD serum level and the risk of chronic hepatitis B.

Hepatitis B virus (HBV) infection is a serious public health problem worldwide, with approximately 2 billion people having a history of HBV infection and 350 million of them suffering from chronic HBV infection (1).

Although the host factors (such as infection age, gender and immune status), viral and environmental factors are thought to be involved in affecting the development of CHB. The mechanisms underlying the different clinical outcomes of HBV infection have not been fully understood. Studies indicated that host genetic factors play a critical role in the development of HBV infection, especially single nucleotide polymorphisms (SNPs), is regarded to be one of the determinants for this clinical heterogeneity(2,3). Some polymorphisms have been reported to be involved in susceptibility to CHB in disease severity and progression, or disease prognosis (4,5).

Irisin is encoded by the FNDC5 gene, whose expression is controlled by the peroxi- some proliferator activated receptor gamma coactivator 1 alpha (PGC-1α). PGC-1α is a transcriptional co-activator which does not bind directly to DNA. Studies indicated that the estrogen-related receptor alpha (ERRα) could be a factor that plays a role in PGC-1α binding to DNA. ERRα is encoded by the ESRRA gene and is an orphan nuclear receptor, which has two domains. One of them allows the interaction with DNA, and the second one with a ligand. The ERRα structure is similar to that of the estrogen receptor alpha (ERα), but this receptor does not bind to natural estrogens. ERRα interacts with a canonical sequence of the estrogen response elements (ERRE). ERRα and ERα could compete with each other to bind to similar DNA elements. Together, ERRα binds to DNA, in complex with PGC-1α, to regulate the activity of genes such as FNDC5 (6).

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed as a clinical disease of CHB according to the diagnostic criteria of CHB based on, HBsAg, HBeAg serostatus ,HBV DNA level, biochemical liver function, and ultrasonography

Exclusion Criteria:

* The chronic HBV patients on antiviral therapy will be excluded.
Genetics of Hyperuricemia Therapy in Hmong

To pursue this objective, we will be measuring uric acid at baseline and post 14 days of twice daily allopurinol therapy in 30 Hmong participants with documented gout or hyperuricemia and known genotype for key renal transporters of uric acid.

Minnesota Hmong are a unique population of individuals of South East Asian descent who have been noted to have a higher prevalence of gout and gout related comorbidities compared to non-Hmong. Elevated levels of uric acid are thought to be at the root cause of gout. Elevated levels of serum uric acid can result from either overproduction and or under-excretion. Xanthine oxidase plays a key role in the breakdown of purines to form uric acid. Transporters in the kidney also play a key role in excretion and/or re-absorption of uric acid. The objective of this study is to explore whether genetic variations in renal transporters may influence the disposition of serum uric acid in response to a drug (allopurinol) as well as the disposition of its active metabolite (oxipurinol) which may also be a substrate for these same transporters responsible for uric acid disposition. Genetic variations unique to the Hmong population may explain their increased prevalence in gout and or perceived lack of responsiveness to the drug (allopurinol) used to treat the condition.

Eligibility Criteria:
Inclusion Criteria:

* Both parents are Hmong (self report)
* Self report history of gout, or
* History (within one year) of active use of xanthine oxidase inhibitors, or
* Evidence of serum uric acid ≥ 6mg/dL , or
* Serum uric acid \< 6mg/dL with history of ≥ 2 gout episodes within the last 6 months
* Ability to provide informed consent for participation in the study
* Demonstrate understanding of the study procedures and ability to comply with the study drug for the entire length of the study
* Ability to obtain permission from treating clinician to allow stopping the drug for 10 days

Exclusion Criteria:

* Pregnant women or women of childbearing age sexually active and not using any contraception
* estimated creatinine clearance (eCrCl) \<30ml/min
* Elevated liver enzymes (3 x upper normal limit of liver function tests (AST and ALT))
* Contraindication to receiving allopurinol
* Active participation in other clinical trial (or within 30 days)
Inflammation and Co-Infections in D²EFT

i2-D²EFT substudy is an observational cohort nested within the parent D²EFT study (NCT03017872). D²EFT goal is to compare the standard of care second-line antiretroviral therapy in people living with HIV whose first-line non nucleoside reverse transcriptase-based regimen failed, to two simpler regimens. Approximately 1,000 participants will be enrolled in D²EFT.

Commencing a second-line ART is an important moment when the level of inflammation in participants may be elevated due to first-line ART failure; this level of inflammation should then decrease with the commencement of a new second-line treatment and would be expected to normalise by 48 weeks of second-line treatment, if successful.

The investigators propose to study other factors which can influence the decrease of inflammation. The investigators hypothesise that co-infections may play a role in persistent inflammation. The key-infections of interest will be common frequent infections encounter throughout the world: Human Herpes virus 8, Epstein-Barr virus, Cytomegalovirus and Human papillomavirus, tuberculosis, malaria and other key opportunistic infections. Possible changes of level of inflammation (using the serum level of Interleukin 6) in approximately 200 participants of the D²EFT study will be investigated and measured. The hypothesis is that the presence of other infections than HIV may influence the level of inflammation in participants in therapeutic success.

i2-D²EFT substudy an observational cohort nested within the parent open label phase III/IV randomised controlled trial of simplified second-line therapy, D²EFT (NCT03017872). Participants consenting to D²EFT study will be randomised within the three arms: either ritonavir-boosted darunavir plus two nucleosides or dolutegravir plus two predetermined nucleosides (tenofovir disoproxil fumarate plus lamivudine or emtricitabine) or ritonavir-boosted darunavir plus dolutegravir. Enrolment into the i2-D²EFT substudy is voluntary and optional for participants in D²EFT. Parameters relevant to i2-D²EFT substudy including demographics, arm of randomised ART, HIV history, physical examination, immunological and virological results, episodes of co-infections and adverse events due to any infection or malignancies at required time points will be collected as part of D²EFT study. Substudy specific assessments performed at baseline and at weeks 48 include sample collection for IL-6 dosage plus EBV/CMV/HHV8 testing, and optional anal/cervical HPV screening.

Eligibility Criteria:
Inclusion Criteria:

* Fulfil the eligibility criteria for D²EFT randomisation;
* Being able to give a written informed consent for the i2-D²EFT sub-study.

Exclusion Criteria:

* Unwilling to comply with the i2-D²EFT protocol requirements.
Optimising FSH Dosage During in Vitro Fertilization Fertilization (IVF)

During in vitro fertilisation (IVF) treatment, women receive hormone stimulation with gonadotropins to induce growth of several ovarian follicles. Selecting the optimal dosage of gonadotropin is important to avoid maturation of too few or too many follicles, which may impair the chances of treatment success, lead to treatment cancellation, or serious side effects.

Motivated by the lack of standardised procedures to estimate the optimal dosage of gonadotropins, a patient-specific test has been developed to predict the optimal hormone dosage. By measuring internalisation of gonadotropin by the patient's monocytes isolated form the peripheral blood ex vivo, the Gonadotropin Removal Test determines whether a patient needs increased or reduced hormon doses.

In this clinical study the investigators compare deviation from optimal outcome at oocyte pick-up day in two patient groups. Optimal outcome of stimulation is defined as 10 oocytes collected in the group of patients matching the inclusion criteria of the study.

The control group receives starting hormone dosage assigned by the clinician according to standard clinical procedures. The intervention group receives starting hormone dosage adjusted according to the results of the Gonadotropin Removal Test.


Eligibility Criteria:
Inclusion Criteria:

* Stimulation according to the mid-luteal phase gonadotropin-releasing hormone-agonist protocol
* Pre-selected starting dose \<110 IU or \>270 IU FSH

Exclusion Criteria:

* Risk for hyperstimulation
* Polycystic ovary syndrome
* Endometriosis stage \>III
* BMI\>33
* Anti-mullerian hormone value missing