cyrilzakka/clinical-trials huggingface dataset:
HPV Integration Testing for Human Papillomavirus-Positive Women

Papanicolaou (Pap) triage, with high specificity, has been recommended for primary Human papillomavirus (HPV) testing but is flawed by poor sensitivity and cytologist dependence. the investigators evaluated the potential role of HPV Integration detection in cervical exfoliated cells in HPV-positive women from a clinic-based population.


Eligibility Criteria:
Inclusion Criteria:

Women aged 30-65 years old visiting the gynecologic clinic of hospital

Exclusion Criteria:

1. Not providing informed consent
2. previously confirmed CIN, cervical cancer, or other malignancies
3. previous therapeutic procedure to cervix
4. pregnancy
A Practical Nomogram Based on Systemic Inflammatory Markers for Predicting Portal Vein Thrombosis in Patients With Liver Cirrhosis

Immunothrombosis has recently been used to describe the responses/mechanisms in thrombosis. Systemic inflammatory markers are prognostic markers for a variety of thrombotic conditions; however, their potential value in predicting portal vein thrombosis (PVT) is unknown. This study aimed to establish an easy-to-use nomogram based on systemic inflammatory markers to predict portal vein thrombosis (PVT) in patients with liver cirrhosis.

This retrospective study included 478 patients with cirrhosis between January 2013 and January 2021. Reputed systemic inflammatory markers (systemic immune-inflammation index \[SII\], neutrophil-to-lymphocyte ratio \[NLR\], monocyte-to-lymphocyte ratio \[MLR\], and platelet-to-lymphocyte ratio (PLR)) were measured, and the clinical data were recorded. The independent risk factors for PVT were determined using univariate analyses and multivariate logistic regression analyses, and a nomogram to predict the occurrence of PVT was established. The concordance index, receiver operating characteristic curves, and calibration plots were used to evaluate the performance of the model.

Eligibility Criteria:
Inclusion Criteria:The diagnosis of LC was based on clinical, laboratory, and radiological analyses, and/or liver biopsies. PVT was diagnosed according to the consensus for management of PVT in LC (2020, Shanghai) \[1\]. The inclusion criteria were as follows: (I) age ≥18 years, (II) Doppler ultrasound was the first-choice imaging modality; however, enhanced computed tomography or magnetic resonance imaging could also be used for confirmation at the time of admission to our hospital, and (III) patients with PVT on imaging examination but with insufficient evidence for the diagnosis of cirrhosis, hepatic vein pressure gradient measurement, and liver biopsy. -

Exclusion Criteria:Patients with primary or secondary hepatic malignant tumors, other malignant tumors, hematologic diseases, Budd-Chiari syndrome, non-cirrhotic PVT, inflammatory diseases, and other severe diseases were excluded.

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[18F]FES PET/CT in PAH

In this study positron emission tomography (PET/CT) imaging will be used to evaluate evaluation of estrogen receptor heterogeneity and functionality in Pulmonary Arterial Hypertension (PAH) using the investigational radiotracer \[18F\]fluoroestradiol (FES).

This is a feasibility study of serial FES scanning in female patients with Pulmonary Arterial Hypertension (PAH) to determine whether patients have detectable changes in FES SUV following treatment with fulvestrant on the separate therapeutic protocol IRB# 824861 "Estrogen Receptor Antagonist in Patients with Pulmonary Arterial Hypertension (ERA PAH)". Subjects will undergo up to 2 \[18F\]FES PET/CT scans for this protocol. A baseline FES PET/CT will occur on Day 0 (-2 days) of the companion treatment trial prior to initiation of fulvestrant. The second FES PET/CT scan will occur on week 9 (63 ± 7 days) after initiation of fulvestrant. We will compare SUV values after fulvestrant to pre-treatment values.

Eligibility Criteria:
Inclusion Criteria:

* 1. Women who are post-menopausal, defined as one of the following

  1. \> 50 years old and a) have not menstruated during the preceding 12 months per medical record review or self-report or b) have follicle-stimulating hormone levels \> 40 IU/L at screening OR
  2. \< 50 years and follicle-stimulating hormone levels \> 40 IU/L at screening OR
  3. history of bilateral oophorectomy per medical record review or self-report.

  2. Diagnosis of Pulmonary Arterial Hypertension (PAH) per medical record review.

  3. Patients must be candidates to receive treatment on the companion therapeutic trial "Estrogen Receptor-α Inhibitor in Patients with Pulmonary Arterial Hypertension (ERA PAH)" (IRB# 824861 "ERA PAH")

  4. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion Criteria:

* 1. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician

  2. Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.

  3. Ineligible for the therapeutic trial IRB# 824861 "ERA PAH" entitled "Estrogen Receptor Antagonist in Patients with Pulmonary Arterial Hypertension (ERA PAH)" (IRB# 824861 "ERA PAH")
Technological Home Care: Improving HPN Care With Videophone And Internet Education

The purpose of this study is to help people with home parenteral nutrition (HPN) to avoid infections and feelings of depression or fatigue and to test how their health and quality of life change over time. Another purpose is to test the nurse teaching sessions and the method of obtaining support from the peer partner through videophone.

Aim #1 Hypothesis

1. Dyad (patient-caregiver) participation in health care management and problem-solving method use with professionals will be greater in the experimental group than the control group
2. Dyad reactive depression will be lower in the experimental group than the control group
3. Dyad quality of life will be higher in the experimental group than the control group
4. Dyad health status scores will be higher and the dyad sleepiness scale will be lower in experimental group than the control group
5. Dyad Health Services Use will be lower in the experimental group than the control group
6. Catheter-related infections will be lower in the experimental than control patients

Aim #2 Hypotheses:

1. What is the cost of using the FamTechCare system compared to traditional care?
2. Is there a difference between efficiency scores of the experimental and control groups intervention, boosters and relative to dyads long-term health services use at 24 months?
3. What are the relationships among patient outcome variables and caregivers' rating of virtual nurse caring and caregiver adaption?
4. What are the relationships among use of FamTechCare, dyad participation in health care management scale score and dyad access to the Internet Weighted Score?

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Caregivers of HPN patients short- or long-term HPN
* able to participate in writing and other intervention activities
* able to speak/read/write English or Spanish

Exclusion Criteria:

* Patients with psychiatric disorders (e.g., schizophrenia, hallucinations) and physical disabilities that prevent use of intervention
Clinical Evaluation of CEM-guided Biopsy

CEM-guided biopsy is an optional accessory of Senographe Pristina intended to provide accurate location of lesions in the breast in three dimensions, using information obtained from Contrast Enhanced Mammography (CEM) images. This information provides guidance for a variety of minimally invasive or interventional procedures in the breast such as vacuum assisted biopsy, core biopsy, presurgical localization (e.g. hook wire), and fine needle aspirations (FNA). This device cannot be used for reasons other than its intended use.

This evaluation is being done to learn more about the CEM-guided biopsy. Clinical user and operational feedback is a central part of the development process for medical devices in which information from real clinical use is required to optimize the device prior to commercial release.

Pristina Serena CEM is an option to the standard Pristina Serena breast biopsy unit. It is designed to allow the accurate localization of lesions in the breast in three dimensions, using information obtained from Contrast Enhanced Mammography (CEM) images. It is intended to provide guidance for histological purposes such as core or vacuum-assisted biopsies, for pre-surgical localization procedures, or Fine Needle Aspiration (FNA) for cytopathology analysis.

The main purpose of this evaluation is to collect feedback to assess image readability and look-and feel, usability, workflow and user preference information from physicians and technologists who use CEM-guided biopsy to perform minimally invasive interventional breast procedures under clinical conditions. All feedbacks are collected by observations, interviews and surveys.

The evaluation population consists of adult women, presenting with clinical indication for a breast biopsy procedure after a positive abnormal CEM or MRI examination, and considered eligible for this procedure as per standard of care.

Eligible subjects undergo the clinically indicated breast biopsy procedure using the Pristina Serena CEM-guided biopsy. Region of interest location is determined by using stereotactic pairs of CEM images after injection of iodinated contrast media. All necessary equipment and instrumentation, medications, or other devices required to complete the subject's clinically indicated procedure shall be used and are not expected to be influenced by evaluation participation.

Eligibility Criteria:
Inclusion Criteria:

* Adult women presenting with clinical indication for a breast biopsy procedure after a positive abnormal CEM or MRI examination, and considered eligible for this procedure as per standard of care.
* Are able and willing to comply with study procedures
* Are able and willing to provide written informed consent to participate

Exclusion Criteria:

* Findings not accessible for stereotactic guidance biopsy
* Are currently lactating
* Have breast implants
Effect of Double Surgical Glove on Comfort, Sensitivity and Dexterity

This clinical trial aims to test the effect of double surgical gloves worn in different sizes on the surgical team's comfort, sensitivity, and dexterity.

The purpose of using surgical gloves is to create a protective barrier against blood-borne pathogens. According to studies, gloves can puncture during surgical procedures. Many studies recommend wearing double gloves. However, the World Health Organization reported that in the guideline for surgical site infections published in 2018, there is not enough evidence for wearing double or single gloves to prevent surgical site infections. However, he recommends that the surgical team prefer to use double gloves to protect themselves against punctures.

Although wearing double gloves is considered to be positive in terms of patient and employee safety, it is not preferred by the surgical team in some cases. The sense of touch and sensitivity of the human hand is at the center of surgical procedures. Finger pulp is extremely sensitive and contains many sensory receptors. Placing a barrier, such as a glove, between these sensory receptors and the touched surface may prevent tactile sensitivity in surgical applications. In addition to the advantages of double gloves in terms of patient and employee safety, there are disadvantages such as reduced dexterity and touch sensitivity. In the literature, it has been determined that there are few and old studies examining the effects of double glove use on performance and comfort. Therefore, this study, it was aimed to compare the effects of double surgical gloves worn in different procedures or usage habits (double gloves, large and small gloves) on the comfort, sensitivity, and dexterity of the surgical team.

The study will conduct as a prospective randomized controlled trial. After obtaining verbal and written consent from the participant, the study will conduct with various data collection forms. These forms are; the introductory information form, surgical glove evaluation form, and Visual Analogue Scale. Participants will randomize. After randomization, participants will be included in one of four groups. All procedures will be applied to participants in all groups. Group I (n=20), Group II (n=20), Group III (n=20), Group IV (n=20). Procedure A: Double gloves, participants will wear both gloves in their surgical glove size. Procedure B: Double gloves, participants will wear their own glove number and half a size bigger glove on top. Procedure C: Double gloves, participants will wear a half-size big glove and their own glove number on top. Procedure D: Participants will wear one glove (control procedure). Open surgeries with a duration of 90-120 minutes will be preferred for evaluation.

Eligibility Criteria:
Inclusion Criteria:

Taking part in the surgical team Six months or more of surgical experience

Exclusion Criteria:

Latex allergic
A Prospective Trial of Elective Extubation in Brain Injured Patients.

Identifying the optimal time of extubation in a brain injured population should improve patient outcome. Brain injured patients usually remain intubated due to concerns of airway maintenance. Current practice argues that unconscious patients need to remain intubated to protect their airways. More recent data however suggests that delaying extubation in this population increases pneumonias and worsens patient outcomes.

We designed a safety and feasibility study of randomizing brain injured patients into early or delayed extubation. The purpose was to gain insight into patient safety concerns and to obtain estimates of sample size needed for a larger study.


Eligibility Criteria:
Inclusion Criteria:

1. Resolution or improvement of any pulmonary process requiring mechanical ventilation.
2. Adequate gas exchange.
3. Adequate ventilation.
4. Respiratory rate to tidal volume ratio \<105.
5. Core body temperature \< 38 degrees celsius.
6. Hemoglobin \> 8 grams per deciliter.
7. No sedative medications for 2 hours.

Neurological requirements included:

1. GCS ≤ 8.
2. Intracranial pressure (ICP) \< 15 cm of water and a cerebral perfusion pressure (CPP) \> 60 mm Hg for patients with intracranial pressure monitors.

Exclusion Criteria:

1. Age \< 18 years.
2. Lack of informed consent by the patients' surrogate.
3. Dependence on mechanical ventilation for at least two weeks prior to enrollment.
4. Patients with tracheostomies.
5. Intubation instituted for therapeutic hyperventilation.
6. Planned surgical or radiological intervention within the next 72 hours.
7. Anticipated neurological or medically worsening conditions (i.e develop cerebral edema or vasospasm).
8. Patients intubated for airway preservation due to airway edema (cervical neck injuries or surgery) as opposed to airway protection.
Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results

This trial is conducted in Africa, Asia, Europe, and North and South America. The aim of this trial is to determine the long term effect of liraglutide on cardiovascular events in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria: - Type 2 diabetes - Age min. 50 years at screening and concomitant cardiovascular, cerebrovascular or peripheral vascular disease or chronic renal failure or chronic heart failure OR age min. 60 years at screening and other specified risk factors of cardiovascular disease - HbA1c: 7.0% or above - Anti-diabetic drug naive or treated with one or more oral anti-diabetic drugs (OADs) or treated with human NPH insulin or long-acting insulin analogue or premixed insulin, alone or in combination with OAD(s) Exclusion Criteria: - Type 1 diabetes - Use of a glucagon-like peptide-1 (GLP-1) receptor agonist (exenatide, liraglutide or other) or pramlintide or any dipeptidyl peptidase 4 (DPP-4) inhibitor within the 3 months prior to screening (trial start) - Use of insulin other than human NPH insulin or long-acting insulin analogue or premixed insulin within 3 months prior to screening. Short-term use of other insulin during this period in connection with intercurrent illness is allowed, at Investigator's discretion
Assessing the HERV-W Env ANtagonist GNbAC1 for Evaluation in an Open Label Long-term Safety Study in Patients With Multiple Sclerosis

The humanised IgG4 monoclonal antibody GNbAC1 targets the envelope protein (Env) of the human endogenous multiple sclerosis-associated retrovirus (HERV-W MSRV), which may play a critical role in multiple sclerosis.

The study assesses the long-term safety of GNbAC1 in patients with RRMS and the long-term efficacy of GNbAC1 in terms of MRI outcomes, relapse rate, disability and disease progression.


Eligibility Criteria:
Main Inclusion Criteria:

* Patients must have completed Period 2 of study GNC-003 and must meet all eligibility criteria for the GNC-004 study
* Patients (male or female with reproductive potential) must agree to use highly effective methods of birth control
* Provision of written informed consent to participate prior to any trial procedure as shown by signature on the subject consent form.

Main Exclusion Criteria:

* Patients not having completed the study GNC-003
* Pregnancy
* The emergence of any disease diagnosis during the course of study GNC-003 that is not MS and could better explain the patient's neurological signs and symptoms
Subarachnoid Hemorrhage Recovery And Galantamine

The purpose of this study is to examine the effects of the study drug--Galantamine-on patients with subarachnoid hemorrhage (SAH). The study will examine how patients with SAH will tolerate the study drug and how it may improve brain functioning in patients after SAH.


Eligibility Criteria:
Inclusion Criteria:

* Spontaneous subarachnoid hemorrhage
* Presentation to hospital within 72 hours of symptoms
* Fisher grade 3 hemorrhage (thick subarachnoid clot) on initial computed tomography (CT) scan
* Hunt and Hess grade 1-5 at time of randomization
* Presence of a cerebral aneurysm on computed tomographic angiography (CTA) or Angiogram for which clipping or coiling is possible
* Ability to obtain medication within 36 hours of presentation

Exclusion Criteria:

* subarachnoid hemorrhage (SAH) due to causes other than aneurysm rupture (trauma, arteriovenous malformation (AVM), mycotic aneurysms, Moyamoya)
* Pre-existing disability with modified Rankin Scale (mRS) score ≥2,
* Renal disease as defined by creatinine clearance less than 9 milliliters/min
* History of severe hepatic impairment (Child-Pugh score of 10-15)
* History of chronic obstructive pulmonary disease (COPD) or asthma
* History of dementia
* Co-morbid conditions likely to complicate therapy, including clinically significant arrhythmia, acquired immune deficiency syndrome (AIDS), autoimmune disease, malignancy, and expected mortality within 72 hours
* Expected mortality within 72 hours as determined by PI, treating neurointensivist and neurosurgeon. (Clinically manifested by no attempt at securing aneurysm)
* Females who are pregnant.
Safety, Tolerability and Pharmacokinetics of MORAb-003 in Subjects With Advanced Ovarian Cancer

The purpose of this study is to establish the safest dose of MORAb-003 in subjects with advanced ovarian cancer. MORAb-003 is an antibody directed to an antigen on the surface of ovarian cancer cells.


Eligibility Criteria:
Inclusion Criteria:

1. Female subjects, ≥18 years of age, with a histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal adenocarcinoma, with or without elevation of CA 125, confirmed at the Department of Pathology, Memorial Sloan-Kettering Cancer Center.
2. Subject must have disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) or evaluable by clinical signs/symptoms (e.g., ascites, pleural effusion, or lesions of less than 2 cm) supported by CA-125, radiologic, or pathologic studies conducted within 4 weeks prior to study entry.
3. Subject must have failed at least a standard (platinum-containing) chemotherapy regimen and be considered platinum refractory or resistant.
4. Life expectancy ≥3 months, as estimated by the investigator.
5. Karnofsky performance status ≥70%.
6. Subjects must be surgically sterile, postmenopausal, or using an effective form of contraception.
7. Subjects undergoing treatment with other medications must have been on a stable medication regimen for at least 30 days prior to Study Day 1.
8. Laboratory and clinical results within the 2 weeks prior to Study Day 1 as follows:

   Absolute neutrophil count (ANC) ≥1.5 x 109/L Platelet count ≥100 x 109/L Hemoglobin ≥10 g/dL Serum bilirubin ≤2.0 mg/dL Aspartate transaminase (AST) ≤2.5 x upper limit of normal (ULN) Alanine transaminase (ALT) ≤2.5 x ULN Serum creatinine ≤2.0 mg/dL Amylase ≤1.5 x ULN Lipase ≤1.5 x ULN
9. Spirometry indicating a FEV1 of \>79% of predicted.
10. Subject must be willing and able to provide written informed consent.

Exclusion Criteria:

1. Known central nervous system (CNS) tumor involvement.
2. Evidence of other active malignancy.
3. Active asthma or other chronic lung disease.
4. Clinically significant heart disease (e.g., congestive heart failure of New York Heart Association Class III or IV, angina not well controlled by medication, or myocardial infarction within 6 months).
5. ECG demonstrating clinically significant arrhythmias (Note: Subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal SVT, are eligible).
6. Active serious systemic disease, including active bacterial or fungal infection.
7. Chronic inflammatory bowel disease.
8. Chemotherapy, biologic therapy, or immunotherapy within 3 weeks prior to enrollment.
9. Breast-feeding, pregnant, or likely to become pregnant during the study.
10. Active hepatitis or HIV infection.
11. Subjects who have received a previous monoclonal antibody therapy and have evidence of an immune or allergic reaction, or documented HAHA.
12. Subjects with large ascites (≥500 cc based on results of most recent CT scan).
Efficacy and Safety Study on Agilis NxT Introducer in AF Patients

To prove if the success rate of curative treatment of atrial fibrillation in left atrial circumferential pulmonary vein ablation is higher by using a steerable transseptal introducer giving access to the left atrium then by using a conventionally introducer with fixed curve.

To prove if the success rate of curative treatment of atrial fibrillation in left atrial circumferential pulmonary vein ablation is higher by using a steerable transseptal introducer giving access to the left atrium then by using a conventionally introducer with fixed curve; in patients with paroxysmal or persistent symptomatic Atrial Fibrillation.

Primary Endpoint: rate of patients in stable sinus rhythm at 6 Month Follow Up

Eligibility Criteria:
Inclusion Criteria:

* Paroxysmal or persistent symptomatic atrial fibrillation
* Resistant to at least 1 anti arrhythmic drug
* Left atrial diameter less then 60 mm (TTE, parasternal)
* Atrial fibrillation documented by ECG
* Patient is willing and available to perform all Follow Ups

Exclusion Criteria:

* Permanent atrial fibrillation
* Pre existing left atrial fibrillation ablation
* Atrial fibrillation due to reversible cause
* Known intracardiac or other thrombi
* Pregnancy
* Women of child bearing potential without negative pregnancy test within 48 hours prior to ablation
* Contraindication for anticoagulation