cyrilzakka/clinical-trials huggingface dataset:
Endoscopic Ultrasound-guided Coil With Cyanoacrylate Injection Versus Balloon-Occluded Retrograde Transvenous Obliteration in Managing Patients With Gastric Varices

Gastrointestinal bleeding is a common complication of liver cirrhosis which caused by esophageal and gastric varices. The risk of bleeding from gastric varices is relatively low. However, the bleeding is usually significant and severe.

Current guidelines recommend endoscopic glue injection as the first line of treatment for gastric variceal bleeding.

Although this technique has been shown to be effective, it is associated with many severe adverse events including systemic embolization, fever, chest pain, and even death. The rate of hemostasis has been reported to be as high as 91-100% but the rebleeding rate from gastric varices still present.

Endoscopic ultrasound (EUS) guided therapy has recently been introduced as a more effective and safer option than endoscopic therapy for gastric varices. EUS-guided therapy includes EUS guided Cyanoacrylate injection alone or in combination with EUS-guided coiling. It offers the advantage of directly visualizing the varices and delivering targeted therapy.

A standard endoscopic examination only allows the evaluation of superficial varices. The use of Endoscopic ultrasound facilitates evaluation of peri-gastric and perforating vessels, which are directly involved in variceal development. EUS also facilitates accurate placement of the coil and preserves the naturally formed splenorenal shunt.

Balloon-occluded retrograde transvenous obliteration(BRTO) has been reported to achieve satisfactory bleeding control rates for isolated gastric varices with High hemostasis rates and low rebleeding rate.

Despite all these promising results, there are scarce studies describing and comparing the efficacy of EUS-guided therapy and BRTO in patients with gastric varices. Further prospective comparative studies are needed.


Eligibility Criteria:
Inclusion Criteria:

• Presence of fundal gastric varices either: High risk for rupture; diagnosed by upper endoscopy i.e. large size or presence of red color spot.

Bleeding varices; diagnosed by upper endoscopy with good hemostasis achieved with endoscopic treatment.

Bleeding varices; diagnosed by upper endoscopy but hemostasis could not be achieved with endoscopic treatment.

* Fundal gastric varices with Presence of contraindication for TIPS such as repeated attacks of hepatic encephalopathy due to Portosystemic shunt, Model of End Stage Liver disease score (MELD) \>18.
* Fundal varices with catheterizable portosystemic shunt such as gastrorenal shunt or gastrocaval shunt.

Exclusion Criteria:

* Complete portal vein thrombosis
* Splenic vein thrombosis
* Intractable ascites (TIPS is better)
* Uncontrolled esophageal varices (high risk for bleeding) and TIPS is better
In Vitro Activity of Ceftolozane/Tazobactam and Imipenem/Relebactam in Clinical Isolates of Pseudomonas Aeruginosa and Enterobacterales Collected From Hematology and Oncology Patients

The purpose of the ACTHEON Study is to evaluate the in vitro activity of ceftolozane-tazobactam, imipenem-relebactam and comparator agents (amoxicillin- clavulanate, piperacillin-tazobactam, ceftazidime, cefotaxime, cefepime, imipenem, meropenem, levofloxacin and amikacin; see list more details on page 7) against clinical isolates of P. aeruginosa and Enterobacterales prospectively collected from hematology and oncology patients with complicated intra-abdominal infections (cIAIs), complicated urinary infections (cUTIs), lower respiratory tract infections (LRTIs), and blood stream infections (BSIs) from 15 participating centers in Spain


Eligibility Criteria:
Inclusion Criteria:

* P. aeruginosa isolates
* Enterobacterales isolates

Exclusion Criteria:

* Non P. aeruginosa isolates
* Non Enterobacterales isolates
A Randomized, Placebo-Controlled, Two-Period, Crossover Study to Evaluate the Effect of Lurasidone HCl on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects

A Phase 1, drug, drug, interaction study between Lurasidone HCl and Ortho-tri cyclen


Eligibility Criteria:
Inclusion Criteria:

* Subject is female between 18 and 40 years of age
* Female subjects of reproductive potential will demonstrate a negative serum β-human chorionic gonadotropin level consistent with the non-gravid state at the screening visit
* Subject agrees to take the triphasic oral contraceptive, Ortho Tri-Cyclen™, throughout the study.
* Subject has a history of regular menstrual periods with no substantial breakthrough bleeding episodes while taking Ortho Tri-Cyclen™.
* Subject has a body mass index that is \< 33 kg/m2 (see Appendix 1).
* Subject is judged to be in good health
* Subject must have a negative hepatiti and HIV antibody at screening.
* Subject has no clinically significant abnormality on screening ECG.

Exclusion Criteria:

* Subject has a history of major GI abnormalities/peptic ulceration, hematological, genitourinary, cardiovascular (including hypertension), renal, hepatic, pulmonary, psychiatric, endocrine (including diabetes) or metabolic (including glaucoma), neurologic or cerebrovascular disease, or any history of cancer.
* Subject has systolic blood pressure ≥ 140 mm Hg and/or diastolic blood pressure ≥ 90 mm Hg at screening.
* Subject has a history of any chronic and/or active hepatic disease including elevations of serum transaminases, hepatitis, biliary tract disease, or a history of any gastrointestinal surgery.
* Subject has any other acute or chronic medical or psychiatric condition that, in the opinion of the investigator, would limit the patient safety or confound the results of the study.
* Subject has an ECG at screening with PR \> 240 msec; QRS complex \> 120 msec; QTcB \> 450; or any significant morphologic changes other than nonspecific T-wave changes.
* Subject is currently a user of any illicit drugs (including "recreational use") including marijuana, or has recently used illicit drugs, or has a history of drug or alcohol dependence in the past year or abuse within the last 3 months.
* Subject consumes excessive amounts of alcohol
* Subject has had surgery within last 12 weeks, donated a unit of blood (within 4 weeks), or participated in another clinical study within 30 days of screening.
* Subjects with hypertension, hyperlipidemia, and diabetes should also be excluded. (See package circular under "Contraindications")
* Subject has clinically significant abnormalities at screening clinical examination or laboratory safety tests
* Subject has a prolactin level of over 200 ng/mL at screening.
A Retrospective Study of Anti-Vascular Endothelial Growth Factor (VEGF) Injections for Retinal Vein Occlusion or Diabetic Macular Edema

This retrospective data review study will evaluate anti-VEGF injections for retinal vein occlusion (RVO) or diabetic macular edema (DME).


Eligibility Criteria:
Inclusion Criteria:

* Macular edema in the study eye due to RVO or DME
* Received an anti-VEGF injection in the study eye on or after June 2010 for RVO and on or after August 2012 for DME

Exclusion Criteria:

* None
Tolerance of Healthy Term Infants Fed Infant Formulas

The objective of the study is to assess comparative gastrointestinal tolerance of normal term infants to various milk-protein infant formulas.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, term infants; singleton birth; 37-42 weeks of age; \>2490gms at birth; 0-8 days of age

Exclusion Criteria:

* medications/foods/formulas affecting GI tolerance;adverse medical history with possible effect on tolerance or growth
Improving Care for Patients With Diabetes and Poor Numeracy Skills

The aim of this research will be to perform a randomized controlled trial (RCT) of a new diabetes educational intervention that teaches self-management skills that compensate for poor numeracy skills among a sample of patients with diabetes and low numeracy.

Results of the National Adult Literacy Survey (NALS) suggest that over 90 million adult Americans have poor quantitative skills. Numeracy, the ability to understand and use numbers and math skills in daily life, may be particularly important to patients with diabetes because caring for diabetes often requires self-management skills that rely on the daily application of math skills, such as counting carbohydrates, interpreting blood glucose monitoring, applying sliding scale insulin regimens, and calculating insulin to carbohydrate ratios. Presumably diabetes patients with poor numeracy have more difficulty with self-management and are at risk for poorer clinical outcomes, but to date, there are no published studies that rigorously examine the role of numeracy in diabetes. We have recently completed the initial development of a new scale to measure numeracy in patients with diabetes: the Diabetes Numeracy Test (DNT).

The aim of this research will be to perform a randomized controlled trial (RCT) of a new diabetes educational intervention that teaches self-management skills that compensate for poor numeracy skills among a sample of patients with diabetes and low numeracy. We hypothesize that a group of patients with poor numeracy who are taught self-management skills that accommodate their poor numeracy will have: (1) improved treatment satisfaction and perceived self-efficacy, (2) improved performance in self-management tasks, and (3) improved glycemic control compared to a control group that receives usual education.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of Type 1 or 2 Diabetes;
2. most recent A1C greater than or equal to 7.0%;
3. Referred to the Diabetes Improvement Program for diabetes care;
4. Age 18-80;
5. English Speaking.

Exclusion Criteria:

1. Patients with corrected visual Acuity \>20/50 using a Rosenbaum Pocket Vision Screener, or
2. Patients with a diagnosis of significant dementia, psychosis, or blindness.
Imaging Malignant Glioma With 68Ga-DOTATOC PET/CT

The purpose of this study is to characterize tumour uptake of somatostatin analog 68Ga-DOTATOC in patients with either primary or recurrent malignant glioma. The investigators hypothesis is that some primary and recurrent malignant gliomas overexpress SST2 receptor which can be imaged with 68Ga-DOTATOC PET/CT. The investigators also hypothesize that tumor uptake of 68Ga-DOTATOC correlates with immunohistochemically determined SST2 receptor status of the tumor specimen.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 to 70 years old
* Language spoken: Finnish or Swedish
* Performance status: Karnofsky score 70 or better or WHO performance status 2 or better
* Supratentorial malignant glioma based on MRI imaging
* Supratentorial recurrent glioma based on MRI and/or \[11C\]methionine PET imaging
* Patients must be able to understand the meaning of the study and sign the appropriate Ethical Committee approved informed consent documents in the presence of the designated staff

Exclusion Criteria:

* Any medical or psychiatric condition that compromises the subject´s ability to participate in the study
* Any other significant disease including liver or renal disease
* Pregnant or lactating women
Standing Cognition and Co-morbidities of POTS Evaluation

The purpose of this study is to evaluate cognition in patients with postural tachycardia syndrome (POTS) while lying down and standing and to assess the prevalence of hypermobile Ehlers-Danlos Syndrome in POTS.


Eligibility Criteria:
Inclusion Criteria:

* Previously diagnosed with POTS, or healthy control
* Age between 13-60 years
* Participants may be any race, ethnicity, sex, or gender
* Able and willing to provide informed consent

Exclusion Criteria:

* Inability to give, or withdrawal of, informed consent
* Age ≤ 13 or ≥ 61 years
* Prisoners
* Unable to stand
Frequency and Risk Factors of Congestive Heart Failure in Dialysis Patients

This study aims :

To assess the frequency of heart failure in patients with end-stage renal disease on regular dialysis.

To identify the risk factors of heart failure in patients with end-stage renal disease.

To assess the impact of duration of dialysis on heart failure and its prognosis

Heart Failure is defined as a complex clinical syndrome that can result from any structural or functional cardiac disorder that impairs the ability of the ventricle to fill or eject blood with diagnosis relying on clinical examination and associated with significant mortality and morbidity. Congestive heart failure (CHF) is a cardiovascular complication in which the heart becomes unable to supply a sufficient amount of blood to meet the metabolic requirements and fulfill the body's oxygen demand.

CHF is an independent risk factor for early mortality in ESRD patients. More than half of all deaths among ESRD patients are due to cardiovascular disease (CVD). Cardiovascular changes secondary to renal dysfunction, including fluid overload, uremic cardiomyopathy, secondary hyperparathyroidism, anemia, altered lipid metabolism, and accumulation of gut microbiota-derived uremic toxins like trimethylamine N-oxidase (TMAO), contribute to the high risk for CVD in the ESRD population. Also, conventional hemodialysis (HD) itself poses myocardial stress and injury to the already compromised cardiovascular system in uremic patients.

The characteristics of cardiovascular dysfunction observed in dialysis patients are distinct from those noted in the general population. Although traditional cardiovascular risk factors in patients with end-stage renal disease (ESRD) are highly prevalent, they play only a partial role in the excessive cardiovascular morbidity and mortality of this population. The paradoxical association between several traditional risk factors, such as body mass index, blood pressure (BP) and serum cholesterol, and mortality have been previously reported.

In the ESRD population, Hemodialysis (HD) contributes itself to the development of CHF with sustained fluid overload a major cause of hypertension, heart failure, and mortality in patients with ESRD. We postulate that repeated myocardial micro-injury during maintenance hemodialysis may lead to irreversible cardiac dysfunction and subsequent heart failure and death in some patients.

Eligibility Criteria:
Inclusion Criteria:

* ESRD patient on regular hemodialysis

Exclusion Criteria:

* AKI patients on HD
* Patients discontinued therapy during the study period will be excluded.
* Patients with structural heart disease (congenital or valvular heart disease)
* Patients with obstructive or restrictive lung diseases.
Using Dexmedetomidine Prior to Intubation in Neonates

Neonatal intubations are performed routinely in a NICU. Most intubations are still performed without the administration of medications (awake intubations). Some of the reasons are unavailability of a single good medication, the ease of administration, the physicians comfort level, side effects of medications including apnea, bradycardia, hypotension. Some units use a cocktail of different medications, each with their own side effects We are proposing to study the effects of a single medication, dexmedetomidine (precedex) for the purpose of sedation prior to intubation in neonates.

This study will compare the efficacy of a single dose of dexmedetomidine to controls.

This is an interventional un-blinded, randomized, prospective pilot study to examine the efficacy of dexmedetomidine in reducing time to intubation, pain/discomfort associated with intubation and maintaining better oxygen saturations in neonates during intubation. The study will be done in the Neonatal Intensive Care Unit at Maimonides Medical Center.

Parents of babies requiring intubation will be approached by the Neonatal attending / fellow to obtain consent for the study. If a consent is obtained, babies will be randomized to a control or study group. Babies in the control group will undergo routine intubation by a neonatologist but with monitoring of the vital signs, those in the study group will receive the study drug 10 minutes prior to intubation.

Data Collection Procedures:

The research data will reside in an encrypted laptop issued by MIS that is housed in the Division of Newborn Medicine, within the medical center.

The data will be accessible to all researchers. If needed, de-identified data will be stored/shared on the Maimonides share point website for statistical and backup purposes.

The data that will be collected are heart rate, respiratory rate, oxygen saturation, measured continuously, and blood pressure measurement every five minutes. Data will be collected 15 minutes before, during and 30 minutes after intubation.

Eligibility Criteria:
Inclusion Criteria:

* neonates
* elective intubation
* admitted to the NICU
* Less than 44 weeks corrected gestational age requiring intubation

Exclusion Criteria:

* babies requiring emergent intubation
* Neonates with birth weight\<1250 grams and \<1 week of postnatal age
* Neonates with major congenital malformations
* Neonates with preexisting hypotension (MAP \< Gest Age)
* Neonates with complex congenital heart disease and heart block
Pycnogenol for the Treatment of Lymphedema

The objectives of this study are to evaluate the effectiveness of Pycnogenol (French maritime pine bark extract) for arm lymphedema in women following treatment for breast cancer, to evaluate the accuracy and sensitivity of bioelectric impedence as a measurement of lymphedema of the arm, and to validate the proposed arm lymphedema quality-of-life questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* \> 6 months from last surgical and/or radiation treatment to the affected axilla
* Unilateral lymphedema of the upper extremity

Exclusion Criteria:

* May not be receiving or be scheduled to receive cytotoxic or radiation chemotherapy treatment while on this study
Prediction of Back Disability in Adults With Low Back Pain

Low back pain (LBP) is one of the most enormous and challenging disorders. LBP represents a leading cause of disability worldwide. A number of variables (clinical, functional and mechanical) may predispose to back disability. Clinical variables such as pain may affect the patient ability to move and also may result in muscle spasm that led to more pain and movement restriction. Further, functional capabilities may affect the patient and when reduced may lead to disability. Moreover, biomechanical factors such as abnormal posture creates abnormal stress and strain in many spinal structures which are considered predisposing factors for pain and disability.

There is a gab of evidence to examine the relationships between those variables and to predict disability in patients with chronic nonspecific low back pain using various variables.


Eligibility Criteria:
Inclusion Criteria:

- age between 20 and 40 years, either sex, and symptoms lasting longer than three months, which imply chronicity

Exclusion Criteria:

* Pregnancy, Spinal pathologies or surgery, or any other deformities or visual or auditory issues, as well as ongoing physical or medical treatment for LBP
Non-Inferiority Study Comparing the Subunit Vaccines Influvac and Agrippal in China

In the study Influvac will be compared to Agrippal, another subunit influenza vaccine that is already on the market in China. The main objective of the study is to show that both vaccines are comparable with regard to efficacy. In addition, safety and efficacy data with Influvac will be assessed in the Chinese population.


Eligibility Criteria:
Inclusion Criteria:

* signed and dated informed consent
* being healthy
* mental health enough to understand the study, the informed consent form and the questionnaire

Exclusion Criteria:

* known to be allergic to constituents of the vaccine
* having an autoimmune disorder, taking immunomodulating drugs or having immune disfunction secondary to HIV
* having had a documented serious adverse reaction to previous influenza vaccination
* having had documented influenza infection or vaccination in the six months prior to the start of the study
* having received any other vaccines, immunoglobulins or investigational drugs in the month prior to the start of the study
Local Anesthetic Wound Infusion and Functional Recovery After Colon Surgery

This is a double blinded randomized controlled trial in patients undergoing colon open surgery. The purpose is to evaluate the effectiveness of two different analgesic techniques on functional recovery after surgery.

Twenty five patients will receive thoracic epidural analgesia plus patient controlled analgesia (PCA) (epidural analgesia group) and 25 patients wound infiltration of local anesthetic plus PCA (wound infusion group).

Hypothesis: the postoperative recovery of patients receiving local anesthetic wound infusion will be faster than patients receiving thoracic epidural analgesia.

Functional recovery, pain intensity, opioid consumption and side effects, length of hospital stay and biological markers of inflammation after surgery will be measured in both groups.

This is double blinded randomised study of patients undergoing colon open surgery. One group of patients will receive thoracic epidural analgesia plus patient controlled analgesia (PCA) (epidural analgesia group) and the other group will receive infiltration of local anesthetic plus PCA (wound infusion group). Functional restoration, assessed by self-administered quality of Life questionnaires (SF-36, CHAMPS, ICFS) and 2 and 6 min walking test will be assessed in the two groups at 3 and 8 weeks after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective open colon surgery

Exclusion Criteria:

* ASA physical status 4
* history of:

  * hepatic failure (liver enzymes abnormally elevated)
  * renal failure (creatinine over 150 mmol/L)
  * cardiac failure
  * organ transplant
  * diabetes
  * morbid obesity (BMI \> 40 kg/m-2)
  * chronic use of opioids
  * allergy to local anaesthetics
* History of seizure
* contraindications to the insertion of epidural
* INR \> 1.3, PTT \> 44 second, platelets \< 150.000 per microliter,
* previous spinal surgery limiting the insertion)
* inability to comprehend pain assessment
COVID-19 Recovered Volunteer Research Participant Pool Registry

This is a prospective observational registry of COVID-19 recovered patients who are no longer symptomatic. This Registry is intended to serve as a pool of individuals that can participate in studies associated with serological testing, characterization of immunity and immune response, vaccine development, and convalescent plasma donors.


Eligibility Criteria:
Inclusion Criteria:

* All patients seen the in emergency room, admitted patients, or seen in outpatient clinics that are:

  * Tested Positive for COVID-19 and recovered
  * Suspected to have COVID 19 and validated with serological testing
  * Suspected to have COVID 19 by symptoms, clinical course, and laboratory testing ruling out other respiratory viral disease
Safety and Efficacy of Entospletinib With Vincristine and Dexamethasone in Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)

The primary objective of this study is to evaluate the safety of entospletinib in combination with vincristine (VCR), and dexamethasone (DEX) in adults with previously treated relapsed or refractory B-cell lineage acute lymphoblastic leukemia (ALL).

This is a dose escalation study in which after 2 induction cycles participants may be put on maintenance for up to 36 cycles if they have obtained clinical benefit from the treatment.


Eligibility Criteria:
Key Inclusion Criteria:

* Adults with ALL in need of treatment

Key Exclusion Criteria:

* Diagnosis of Burkitt's Leukemia, or lymphoid blast crisis of chronic myelogenous leukemia (CML)
* History of myelodysplastic syndrome or solid organ transplantation
* Prior allogeneic bone marrow progenitor cell transplant within 100 days or on active immunosuppression for graft versus host disease (GVHD) treatment or prophylaxis within 28 days prior to enrollment

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.