cyrilzakka/clinical-trials huggingface dataset:
Thoracoscopic Versus Endocardial Ablation in Patient With Paroxysmal AF After Failed Initial Endocardial Ablation

The investigators aimed to compare two approaches thoracoscopic epicardial ablation and endocardial catheter ablation after failed initial catheter ablation in patients with paroxysmal atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* failed initial catheter ablation
* paroxysmal atrial fibrillation

Exclusion Criteria:

* chronic lung disease
* body mass index \>35
* longstanding atrial fibrillation 1 year
* previous stroke or transient ischemic attack
* left atrial thrombus
* left atrial size \>65 mm
* left ventricular ejection fraction \<35%
Estrogen Replacement Therapy in Treating Women With Early-Stage Endometrial Cancer

RATIONALE: Estrogen replacement therapy may improve quality-of-life in postmenopausal women with endometrial cancer. It is not yet known whether estrogen replacement therapy will affect cancer recurrence.

PURPOSE: Randomized double-blinded phase III trial to determine the effectiveness of estrogen replacement therapy in treating women who have stage I or stage II endometrial cancer.

OBJECTIVES:

* Determine the effect of estrogen replacement therapy on recurrence free and overall survival in women with a history of stage I or II endometrial adenocarcinoma.

OUTLINE: This is a randomized, double blind study. Patients are stratified according to stage of endometrial cancer (IA vs IB/IC vs II). Patients are randomized to one of two treatment arms:

* Arm I: Patients receive oral conjugated estrogens (Premarin) daily for 3 years.
* Arm II: Patients receive oral placebo daily for 3 years. Patients are followed every 6 months for 3 years and then annually for 2 years.

PROJECTED ACCRUAL: Approximately 2,108 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed grade I, II or III endometrial adenocarcinoma (endometrioid, villoglandular, mucinous, adenosquamous, papillary serous, clear cell, or not otherwise specified)
* Must have had total hysterectomy and bilateral salpingo-oophorectomy within past 20 weeks

  * Surgical stage IA, IB, IC, IIA (occult), or IIB (occult) disease
* Must have had normal mammogram, or a negative breast biopsy after an abnormal mammogram, within past year

PATIENT CHARACTERISTICS:

Age:

* Not specified

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Bilirubin no greater than 1.5 times normal
* SGOT no greater than 3 times normal
* No acute liver disease

Renal:

* Not specified

Cardiovascular:

* No prior thromboembolic disease

Other:

* No prior or current carcinoma of the breast
* No other prior invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* No concurrent hormonal therapy

Radiotherapy:

* Not specified

Surgery:

* See Disease Characteristics
* Recovered from prior surgery

Other:

* No prior cancer treatment that would preclude study therapy
* Concurrent participation on GOG Lap-1 or GOG Lap-2 allowed
Virtual Reality in ICU - PARTNER

This project is designed to have patients participate in a virtual environment with various tasks such as breathing exercises, games to help the brain, and techniques that promote relaxation while hospitalized in the Intensive Care Unit (ICU). The participation in research will last about 5 days and take about 15 to 45 minutes each day.

This is a research study about interacting and engaging in strategies to promote relaxation, improve mood, and stimulate thinking in patients in the Intensive Care Unit (ICU) in the hospital; called PARTNER. PARTNER is played by using a readily available Virtual Reality headset while patients are in the ICU. The researchers hope to learn if engaging with exercises for emotional health and cognitive function reduces delirium and loneliness in the hospital. If patients agree, the patients will be asked to play PARNTER, with a Virtual Reality (VR) device to connect them to a virtual environment with games and/or relaxing scenes while in the ICU. The Virtual environment may include things such as breathing exercise, mindfulness training, and relaxation techniques.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to ICU at University of Kentucky for acute respiratory failure, sepsis or other

Exclusion Criteria:

* Are less than 18 years of age
* Have a pre-existing neurologic disorder
* Have a pre-existing emotional or personality disorder
* Have a history or active mental health disorder or disease
* Experienced an acute neurologic event (e.g., stroke)
* Are currently pregnant
* Are a prisoner
* Receiving hospice care
* Have existing open wounds or pressure ulcers on head or neck
Gastrostomy Tube Placed After Gastropexy Versus Gastrostomy Tube Placed Using the Traditional Push/Pull Techniques

Endoscopic placement of a percutaneous gastrostomy tube is a safe, efficient and well standardized technique. Two variants of this maneuver - the pull and the push techniques - are widespread worldwide. More recently different techniques, that allow the direct insertion of a gastrostomy tube has been described. The common characteristic shared by all these technique is the fact that the gastrostomy tube is inserted directly into the stomach (without passing through the pharynx), after the gastric and abdominal wall have been securely fasten together (gastropexy).

Advantage of direct techniques are the followings:

1. the tube can placed also in the case of an oesophageal stenosis
2. studies suggest that the peristomal wound infection are less frequent using direct techniques
3. in some variants of these techniques, a balloon type gastrostomy tube or a button can be placed also in the case of first positioning. Both the balloon type tube and the button are easy to be changed also at the bed-side.

Drawbacks of the direct techniques are:

1. these technique are easy, but a little more cumbersome than classic push or pull maneuvers
2. operators are often not familiar with direct insertion
3. kits suited for direct insertion are generally more costly than available kits for push or pull placement of gastrostomy tube.

The kit manufactured by the Kimberly-Clark (MIC Introducer kit) allows direct insertion of a balloon type gastrostomy tube or of a button and it is interesting, because it makes simple to perform the gastropexy.

The study aim is to confirm that the use of the Kit Introducer MIC, may allow safe placement of a gastrostomy tube and may reduce the incidence of peristomal wound infection. Furthermore if a balloon type gastrostomy tube or a button are positioned, they may be changed at the bed-side, without referral of the patient to the endoscopic unit or to an other sanitary facility.


Eligibility Criteria:
Inclusion Criteria:

* all consecutive patients, candidates to percutaneous endoscopic gastrostomy placement for any common clinical indication, in the centres participating to the study.

Exclusion Criteria:

* age \< 18
* age \> 85 years old
* pregnancy
* coagulation deficit or anti-coagulant oral therapy
* total gastrectomy
* absence of trans-illumination, verified during esophagogastroduodenoscopy
* pharyngeal or esophageal stenosis, not allowing the passage of a standard scope;
* ascitis
* active gastric ulcer
* the patient or his tutor do not consent to the study
* documented allergy to penicillin
* ASA V.
Evaluation of Prognostic Monitoring for Women Who Have Completed Standard Treatment for Ovarian Cancer

The relationship between immune inflammation-related protein complexes inblood and recurrence or metastasis of ovarian cancer will be studied

100 cases in normal ovarian control group, 100 cases in benign ovarian disease group and 100 cases in malignant ovarian epithelial carcinoma group will be studied. Change regularity of ovarian cancer specific immune inflammation-related protein complexes in blood will be studied. The relationship between disease-specific protein complexes and pathological state of patients will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Normal ovary control
* Ovarian benign disease
* Ovarian malignant epithelial carcinoma

Exclusion Criteria:

* Male
* Age above 70
* Suffering from other malignant tumors
* Non-compliant patient
Digital Versus Analog Pleural Drainage in Patients With Pulmonary Air Leak

The amount of air leaking from a chest tube can be measured in two main ways:

1. electronic monitor connected to the chest tube
2. numerical (non-electronic) monitor connected to the chest tube

For people who have had lung surgery, it is important to understand the impact of measuring air leaks accurately in both the short term and the long term. An electronic medical device called Thopaz measures air leak electronically. Another medical device called Pleur-evac measures air leak numerically. The purpose of this study is to understand the accuracy of the method used by doctors and nurses to determine if a chest tube has an air leak. It is also important to determine the size or severity of an air leak.

Patients with air leaks following lung surgery will be assessed by a target number of 6 observers each (three nurses and three MDs) who will be randomly asked to participate. Patients will first be connected to the numerical air leak detector, followed by the electronic air leak detector. Observers will record their responses for each device. They will be blinded to responses from other observers.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or over
* Male and Female.
* Air leak occuring after any pulmonary resection
* Air leak persisting on or after the first post-op day of pleural drainage
* Air leak not entirely secondary to poor air seal at the pleural drainage incision site
* Pulmonary resection for benign or neoplastic diagnosis

Exclusion Criteria:

* Tension pneumothorax
* Traumatic or iatrogenic pneumothorax
* Primary or recurrent spontaneous pneumothorax awaiting surgery
* Pneumonectomy patient (history of or current)
Different Designs of Space Maintainer

Purpose: Evaluation of survival rate for three space maintainers (SMs) of different designs versus standard one.

Methods: 52 extraction sites in children of age group of 4-7 years with prematurely-lost 1st primary molar were selected for this study. The whole sample was divided into four groups (13 each). In Group I, Band and loop (B\&L), Group II: Single-sided band and loop (Ss B\&L), Group III: Direct bonded wire (DBW), Group IV: Tube and loop (T\&L). children were recalled at 3, 6, 9, 12,15-month.

Purpose: Evaluation of survival rate for three space maintainers (SMs) of different designs versus standard one.

Methods: 52 extraction sites in children of age group of 4-7 years with prematurely-lost 1st primary molar were selected for this study. The whole sample was divided into four groups (13 each). In Group I, Band and loop (B\&L), Group II: Single-sided band and loop (Ss B\&L), Group III: Direct bonded wire (DBW), Group IV: Tube and loop (T\&L). children were recalled at 3, 6, 9, 12,15-month. Cumulative survival rates of SMs were estimated by means of Kaplan-Meier method with log rank test. Cumulative survival rates of SMs were estimated by means of Kaplan-Meier method with log rank test. Sample size: The total sample size was calculated using Sampsize application with anticipated success on treatment with conventional band and loop 86% , anticipated response on treatment with direct bonded wire 33% 12, at 80% power, and significant level 0.05.

Eligibility Criteria:
Inclusion Criteria:

1. Children and their parents showed cooperation and compliance.
2. Extraction of the first primary molar was not exceeding three months.
3. Angle's class 1 occlusion with normal deciduous molar relation
4. Child not complaining from any systemic disease.
5. The extraction space was of only one missing first deciduous molar with remaining teeth present on mesial and distal side of extraction space.
6. Absence of para-functional habits or abnormal occlusion conditions such as crossbite, open bite, deep bite.
7. No restorative application on the buccal surfaces of abutment teeth, otherwise extra-coronal complete coverage, as stainless-steel crown, was applied only in banded groups.
8. Radiographically, presence of permanent successor.
9. Absence of any pathological evidence on the eruption track of the permanent tooth.
10. Ability to attend follow-up appointments as required.

Exclusion Criteria:

1. Child complaining from any systemic disease.
2. Prescence of para-functional habits or abnormal occlusion conditions such as crossbite, open bite, deep bite
3. Extraction of the first primary molar was exceeding three months.
4. The extraction space resulted from more than one missing deciduous molar
5. Radiographically, absence of permanent successor.
Examining The Effects of Core Stabilization Exercises and Myofascial Release Technique in Individuals With Chronic Neck Pain: A Randomized Clinical Trial

Chronic neck pain is a musculoskeletal disorder that affects people frequently in life.

Postural control is based on the process of correctly identifying and selectively focusing the incoming afferent input of the Central Nervous System (CNS).

The main treatment options for people with neck pain include soft tissue and joint mobilizations, stabilization exercises for the neck, trunk and shoulder muscles, cervical Deckings, relaxation training, strengthening exercises and body awareness and posture training.

In this study, it was aimed to investigate the effects of myofascial relaxation on balance, pain, joint range of motion and functionality in individuals with chronic neck pain by dividing them into two groups in the form of core stabilization and core stabilization and myofascial relaxation.

The study included 45 people between the ages of 18 and 65. In two groups, the core stabilization group will be 22 people, and the core stabilization and myofascial relaxation group will be 23 people. The study period is planned as 6 weeks and 3 sessions per week.


Eligibility Criteria:
Inclusion Criteria:

* Having neck pain that has been going on for at least three months
* The mean pain intensity according to the Visual Analog Scale (GAS) is moderate \[4-6.9 centimeters (cm)
* December\] or be at a severe (7 cm and above) level
* To be between the ages of Dec 18-65
* To be literate and to be a writer
* Volunteering to participate in the study

Exclusion Criteria:

* Having severe degenerative arthritis
* Having a neurological finding due to spinal root compression (Positive upper limb stretching tests,cervical compression test)
* To have a finding due to pressure of the spinal cord (Positive L'hermitte sign, Babinski sign) is
* Having undergone cervical spine surgery
* Having a cervical neck fracture and/or joint subluxation/dislocation
* Having osteoporosis and/or neck pain due to a tumor
* Having a history of primary malignancy
* Being pregnant
* The title refers to neurological disease (Parkinson's, Multiple Sclerosis, etc.)
* Having received physiotherapy and rehabilitation in the last three months
Testing a Reduced Conditioning Regimen FB2A2 Preceded by a Fractionated Radio-immunotherapy (RIT) With 90Y-Epratuzumab Before Allogeneic Stem Cell Transplantation for Patients With Lymphocyte B CD22 Positive Acute Lymphoblastic Leukemia

Determination of the maximum tolerated dose (MTD) of fractionated RIT with epratuzumab radiolabeled with yttrium-90 (90Y-epratuzumab) preceding a reduced conditioning regimen FB2A2 before allogeneic stem cell transplantation.

* Physical examination (screening and follow-up)
* Complete blood counts (screening and follow-up)
* Dosage of FLT3-ligand in plasma (screening and follow-up)
* Blood ionogramme, creatinine hepatic work-up (screening and follow-up)
* Left ventricular ejection fraction at pre-implant assessment
* Immunization test (screening and follow-up)
* Bone marrow aspiration or/and blood CD 22 immunophenotype for minimal residual disease evaluation (screening and follow-up)
* All exams which were initially abnormal and which are necessary for response evaluation and All exams which are needed in case of relapse suspicion.
* Pharmacokinetic of 90Y-hLL2

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Acute lymphoblastic Leukemia (ALL) CD22 + B-type in RC1 with high risk
* B-Cell Acute Lymphoblastic Leukemia (ALL) CD22+ beyond RC1.
* Expression of CD22 ≥ 30% in tumor population evaluated by flow cytometry or immunohistochemistry at diagnosis stage or relapse stage.
* HLA-identical donor intra family or not, without major HLA mismatch (9 / 10th accepted) without contra-indication for stem cell mobilization
* ECOG (Eastern Cooperative Oncology Group) ≤ 2
* Having or not received previously Epratuzumab
* Eligible for an allograft with reduced conditioning regimen
* With a signed informed consent
* Patient in age of children bearing with adequate contraception
* Patient affiliated to or beneficiary of the National Health Service

Exclusion Criteria:

* T-cell ALL
* Known hypersensibility to 90Y-DOTA-hLL2
* Immunization against hLL2 for patients having already received one or several injections of this antibody
* Patient eligible for myeloablative conditioning regimen
* Other prior malignancies must have had at least a 2-year disease-free interval with the exception of successfully treated carcinoma skin cancer or carcinoma in situ of the cervix.
* Patient with progressive psychiatric condition.
* HIV positive, hepatitis B-antigen positive, or hepatitis C positive patients who need a treatment
* Pregnant or breast-feeding women
* Women with childbearing potential without effective contraception
* Serious concomitant and uncontrolled infection
* Usual contraindications in the allogeneic transplant:
* Adult patient protected by the French law
Cahnge in Management of Suspected Early Onset Neonetal Sepsis After Assimilation of Early Onset Sepsis Calculator

Early neonatal sepsis requires rapid and efficient intervention to prevent morbidity and mortality. Management of such a case includes invasive blood examinations, elongation of maternal and neonatal length of stay, and empiric antibiotic therapy. These actions has major side effects. On 2017, Kaiser-Permanente started using a calculator that weighs the chances for early onset neonatal sepsis, and states the best investigation and follow-up regimn for the specific newborn infant. Eversince, policy of managing neonatal suspected early onset sepsis has chaged globally, including in Israel. Current knowledge regarding the local outcome since the use of the calculatir is scarce.

The goal of the study is to evaluate the change in management of suspected neonatal early onset sepsis, including its economic value, between periods before and after assimilation of the calculator in Hillel Yaffe nedica l center.

Early neonatal sepsis requires rapid and efficient intervention to prevent morbidity and mortality. Management of such a case includes invasive blood examinations, elongation of maternal and neonatal length of stay, and empiric antibiotic therapy. These actions has major side effects. On 2017, Kaiser-Permanente started using a calculator that weighs the chances for early onset neonatal sepsis, and states the best investigation and follow-up regimn for the specific newborn infant. Eversince, policy of managing neonatal suspected early onset sepsis has chaged globally, including in Israel. Current knowledge regarding the local outcome since the use of the calculatir is scarce.

The goal of the study is to evaluate the change in management of suspected neonatal early onset sepsis, including its economic value, between periods before and after assimilation of the calculator in Hillel Yaffe nedical center.

Eligibility Criteria:
Inclusion Criteria:

* Newborn unfants born in Hillel Yaffe medical center
* 35 weeks of gestation or more
* Blood culture was taken

Exclusion Criteria:

* Sepsis workup for other reason
* 34 weeks of gestation or less
Feasibility Study of Biobehavioral Stress Reduction Intervention in Patients with Triple Negative Breast Cancer

This clinical trial aims to see if patients with triple negative breast cancer can complete a biobehavioral stress reduction program that also addresses health related social needs (e.g., utilities, transportation, etc.). The stress reduction program is over ten weeks and includes stress reduction (e.g., progressive muscle relaxation), coping, problem solving, communication, and social support. Health related social needs will be evaluated at the beginning of the study, and referrals will be made to social work to help address those needs. The study will examine stress as reported by the patients and also use biological markers.

PRIMARY OBJECTIVES:

I Acceptability of the biobehavioral intervention will be determined using the Client Satisfaction Questionnaire (CSQ). CSQ is an 8-item self-report measure with item assessing different aspects of treatment satisfaction (e.g., quality of service, the degree to which needs were met, overall satisfaction).

III Tolerability of the biobehavioral intervention will be assessed by analyzing pre to post treatment change on the Profile of Mood States.

III Feasibility of the biobehavioral intervention will be assessed using three metrics: 1) accrual number as a percentage of available patients approached; 2) number/percent of patients completing each BBI session; and, 3) number/percent of patients retained and completing 10 BBI sessions.

SECONDARY OBJECTIVE:

I. To examine the feasibility of collecting biomarkers--white blood cell count, C-reactive protein, Interleukin-6, TNF-alpha (α), systolic blood pressure, diastolic blood pressure, heart rate, total cholesterol, high-density lipoprotein; albumin, hemoglobin A1C, body mass index (BMI).

EXPLORATORY OBJECTIVE:

I. To test for pre/post effects of the biobehavioral stress reduction intervention on measures of stress (Impact of Events Scale), mood and psychological symptoms, and allostatic load.

OUTLINE:

Patients receive biobehavioral stress reduction intervention while on study. Patients undergo blood specimen collection at baseline and follow up, and have their medical records reviewed.

Eligibility Criteria:
Inclusion Criteria:

* Age \>=18 years
* Untreated newly diagnosed triple negative breast cancer
* Stages I-III

Exclusion Criteria:

* Prisoners
* Male
* Identifying as American Indian, Alaska Native, Asian, Native Hawaiian or Other Pacific Islander
* Individuals not able to speak and understand English
* Known personal history of ductal carcinoma in situ (DCIS) or invasive breast cancer
* Stage IV breast cancer
Multicenter Clinical Trial for Adult Ph-negative ALL. Non-intensive But Non-iterruptive Treatment

1. evaluation of blast clearance in b/m after 7 days of prednisolone prephase and the efficacy of its substitution by dexamethasone if blast count is 25% and more
2. feasibility for adults of "no interruptions" protocol with 8 weeks induction and 14 weeks consolidation followed by 2-years maintenance.
3. tolerability and efficacy in adults of the prolonged L-asparaginase application (total proposed dose 560.000 IU)
4. feasibility and efficacy of autologous stem cell transplantation for T-cell ALL

1. The blast count in b/m after 7 days of prednisolone \>25% was shown in 64% of patients. The substitution of prednisolone by dexamethasone did not influence survival.
2. "no interruptions" induction was performed in 48% of patients.
3. In 19% of patients the L-asparaginase therapy was stopped due to toxicity.
4. Autologous stem cell transplantation was done in 20% of T-cell ALL patients.

Eligibility Criteria:
Inclusion Criteria:

* Ph-negative precursors ALL
* age 15-55 years
* nontreated
* Eastern Cooperative Oncology Group criterion status 0-3

Exclusion Criteria:

* B-mature ALL
* Ph-positivity
* pretreatment
* Eastern Cooperative Oncology Group criterion status 4