cyrilzakka/clinical-trials huggingface dataset:
Ventilation of the Extremely Premature Infants Optimized by Dead Space Washout

The Continuous Tracheal Gas Insufflation (CTGI) is a ventilation option of conventional mechanical ventilation that is used to reduce or even eliminate the dead space caused by respiratory prostheses. This objective is of particular interest in the smallest preterm infants, where the volume of anatomical dead space due to prostheses is little different from the tidal volume. The principle of this option is to continuously blow an additional flow of 0.2 L/minute at the tip of the endotracheal tube to purge expired CO2 trapped in the prostheses, to have a CO2-free volume of gas available for subsequent insufflation.

The goal of this clinical trial is to learn if Continuous Tracheal Gas Insufflation (CTGI) works to reduce ventilatory dependence in preterm infants after mechanical ventilation. It will also learn about the safety of CTGI. The main questions it aims to answer are:

* Does Continuous Tracheal Gas Insufflation (CTGI) reduce the number of days of non-invasive ventilation in extremely preterm infants who needed mechanical ventilation?
* Does Continuous Tracheal Gas Insufflation (CTGI) reduce the age at the weaning of any ventilatory support and/or oxygen supplementation.

Researchers will compare the clinical outcome of patients mechanically ventilated with the CTGI-device to the outcome of patients ventilated without the CTGI device, to see if the CTGI ventilation works to reduce ventilation dependence.

Participants will:

• Be mechanically ventilated using CTGI (if randomly assigned in the CTGI-group), for the entire endotracheal ventilation period during their stay in the neonatal intensive care unit.


Eligibility Criteria:
Inclusion Criteria:

* Gestational Age at birth between 23 weeks gestation + 0 days and 26 weeks gestation + 6days
* Age between 0 and 7 days of life
* Need for intubation and mechanical ventilation before day 8 of life
* Availability of the Research-associated medical devices
* Beneficiary of a social security system (in France: CMU or securité sociale)
* Parental consent for their infant to participate in this trial

Exclusion Criteria:

* Known Severe Congenital Malformation (potential life-threatening malformation)
* Known Preexisting Severe Intraventricular Haemorrhage (grade 3 or 4) and/or other brain abnormality that can alter life prognosis
* Known Genetic Disorder (potential life-threatening malformation)
* Preexistent mechanical ventilation for a duration of more than 12 hours
* Participation in another interventional research trial before inclusion
Oral Antibiotics After 2-Stage Revision for Infected Total Hip Arthroplasty and Total Knee Arthroplasty

The primary purpose of this study is to compare the re-infection rates in patients undergoing 2-stage revision arthroplasty who receive additional oral antibiotic therapy to those patients who received in-hospital perioperative antibiotic only. Patients will be monitored for re-infection following hospital discharge, defined as deep infection of the joint space/capsule that requires return to the operating room within 24-months of the re-implantation procedure.


Eligibility Criteria:
Inclusion criteria:

Adult patients undergoing 2-stage revision arthroplasty of the knee or hip with the causative organism(s) identified using tissue culture and/or joint fluid analysis that is amenable to oral antibiotic therapy. Patients must be able to tolerate oral antibiotics and agree to participate in the study.

Exclusion criteria:

Patients with a fungal prosthetic joint infection, unable to tolerate or refuse to undergo oral antibiotic therapy, unable to follow-up at the specified intervals, allergic to the therapy of preference, or have an organism that is not amenable to oral antibiotic therapy.
Study of Cerebrospinal Fluid Samples in Diagnosing Carcinomatous Meningitis in Patients With Cancer or Meningeal Syndrome

RATIONALE: Studying samples of cerebrospinal fluid from patients with cancer or meningeal syndrome may help doctors identify biomarkers related to cancer.

PURPOSE: This clinical trial is studying cerebrospinal fluid samples in diagnosing carcinomatous meningitis in patients with cancer or meningeal syndrome.

OBJECTIVES:

Primary

* Evaluate the validity of determining CA 15-3 levels in the cerebrospinal fluid (CSF) using automated immuno-enzymatic methods.

Secondary

* Determine the sensitivity and specificity of these assays in assessing CA 15-3 in CSF.
* Assess favorability of intrathecal production of CA 15-3.
* Determine threshold interpretations of CA 15-3 levels in CSF.

OUTLINE: This is a multicenter study.

Within 15 days of suspected meningeal involvement, blood and cerebrospinal fluid samples are collected. Samples are examined by immunoenzyme assays. Patients with suspected cases of carcinomatous meningitis undergo cerebrospinal MRI.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Diagnosis of metastatic breast cancer with evidence suggestive of carcinomatous meningitis, with or without brain metastasis
  * Other type of cancer with evidence suggestive of carcinomatous meningitis
  * Meningeal syndrome without context of cancer

PATIENT CHARACTERISTICS:

* No other prior cancers
* Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

* No prior intrathecal treatment
* At least 4 weeks since prior interferon
* No concurrent participation in another clinical trial
Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)

A global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy in participants with BTC after surgical resection with curative intent.

This is a Phase III, randomized, double-blind, placebo-controlled, multicenter, global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy (capecitabine, S-1(tegafur/ gimeracil/ oteracil) or gemcitabine/cisplatin) as adjuvant treatment in participants with BTC after resection with curative intent. This study will be conducted in patients with BTC who are at risk of recurrence after resection with curative intent.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or extrahepatic cholangiocarcinoma (CCA) or muscle invasive gallbladder cancer (GBC)) after macroscopically complete resection (R0 or R1)
* Provision of a tumor sample collected at surgical resection.
* Randomization within 12 weeks after resection with adequate healing and removal of drains.
* Confirmed to be disease-free by imaging within 28 days prior to randomization.
* Eastern Cooperative Oncology Group performance status of 0 or 1

Exclusion Criteria:

* Participants with locally-advanced, unresectable, or metastatic disease at initial diagnosis.
* Ampullary cancer, neuroendocrine, mixed neuroendocrine and non-neuroendocrine neoplasms and nonepithelial tumors.
* Any anti-cancer therapy for BTC prior to surgery
* Active or prior documented autoimmune or inflammatory disorders or any severe or uncontrolled systemic disease
* Current or prior use of immunosuppressive medication within 14 days before the first dose
* Thromboembolic event within 3 months
* Active HBV or HCV infection unless treated.
Healthy Life Centers - Municipal Health Care Service for Lifestyle Changes - a Multicenter Intervention Study

A Healthy Life Center (HLC, 'Frisklivssentrale') is a public community-based health service providing lifestyle support programs for physical activity, smoking cessation and diet, to inhabitants with increased risk for development of non-communicable diseases. HLCs intention is to reach physically inactive people who need guidance to get more physically active, and offer them a lifestyle program for three months or more.

The main aim of this study is to study whether the HLCs, organized according to the Norwegian Directorate of Health's guidelines for municipal healthy life centers, affects the participants short term (3 months) and long term (15 months) physical activity level. Also changes in diet, tobacco use, health related quality of life, physical fitness, anthropometry, self-efficacy, motivation, drug use, use of health services and work participation will be assessed. Secondary aim is to study whether there are any moderators, such as HLCs capacity, expertise, and collaboration with other services, that have significance for participants' change. Also it will be studied whether the HLCs result in larger changes in some subgroups (e.g. socioeconomic) of participants than in others.


Eligibility Criteria:
Inclusion Criteria:

* about to start structural support for lifestyle change (regarding physical activity, diet and/or tobacco cessation
* referred to a Healthy Life Center (HLC) from either primary physician, from other health care services or social services, or participants seeking contact themselves without a specific referral.

Exclusion Criteria:

* having participated in an HLC the previous 6 months
Pilot Study of Neo-Adjuvant Everolimus to Treat Advanced Renal Cell Carcinoma - Analysis of Biomarkers

This study will gather data on potential biomarkers in the treatment of advanced renal cell carcinoma (kidney cancer) and investigate their use as indicators of disease response. The results could eventually enable doctors to match levels of therapy to levels of biomarker on an individual basis and to increase the chance of disease response in patients. This study will also test a new paradigm in the treatment approach of advanced kidney cancer by using the drug everolimus in a neo-adjuvant setting, with the overarching goal of decreasing cancer recurrence rates and improving patient outcomes and survival.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age and capable of giving informed consent
* Radiological evidence of RCC consisting of: CT scan with stage T2, T3, T3a, T3b, T4, or any stage T with N1/ 2 and/ or metastatic disease
* Having a nephrectomy and willing to have a kidney biopsy
* ECOG score 0 or 1
* Clear cell histology
* Negative for HIV, Hepatitis B, and Hepatitis C
* Negative pregnancy test for women of child-bearing potential

Exclusion Criteria:

* Stage T1 disease without metastases
* Abnormal laboratory values at screening within the following ranges:
* Absolute neutrophil count ≤ 1.5 × 109/ L; Platelet count ≤ 100 × 109/ L
* Leukocyte count ≤ 3 × 109/ L; Hemoglobin ≤ 80 g/ L; Serum creatinine ≥ 2.0 × the upper normal limit (UNL); Total bilirubin ≤ 1.5 × UNL; AST and ALT ≤ 3.0 × UNL
* Fasting serum cholesterol ≤ 9.0 mmol/ L; Fasting serum triglycerides ≥ 5.0 mmol/L
* Any major illness that, based on the investigator's judgment, will substantially increase the risk associated with a subject's participation in this study
* Other currently active malignancies
* Currently taking any medications known to interfere with the metabolism of everolimus
* Receiving anticoagulation with warfarin
* A history of pulmonary hypertension or interstitial lung disease
Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Heart Transplant Recipients

This purpose of this extension study of patients being treated with EC-MPS is to assess the long term safety of this medication.


Eligibility Criteria:
Inclusion Criteria:

Patients who were participating in the core study CERL080A2401 and have successfully completed the first 12 months of the core study

Exclusion Criteria:

Patients who did not complete the 12-month core study CERL080A2401

Other protocol-defined inclusion/exclusion criteria may apply.
Reliability, Validity, and Cross-cultural Adaptation of the Turkish Version of the Victorian Institute of Sports Assessment for Gluteal Tendinopathy (VISA-G) Questionnaire

The purpose of this study was to investigate adaptation, validity, and reliability of the Turkish version of the Victorian Institute of Sports Assessment for Gluteal Tendinopathy (VISA-G) Questionnaire.

Gluteal tendinopathy, also known as greater trochanteric pain syndrome, interferes with physical function and sleep, and is characterized by pain and tenderness over the greater trochanter.Clinical risk factors for the development of this condition include advanced age, female gender, back pain, overweight / obesity, poor abductor hip function, altered gait parameters, and psychological distress. The Victorian Institute of Sports Assessment for Gluteal tendinopathy (VISA-G) Questionnaire has recently designed as a patient-reported condition-specific outcome measurement tool to assess disability due to tendinopathy. VISA-G is scored between 0 and 100 (a higher score is expected) and consists of eight items covering three main areas (pain, function, and current activity level). Visual analog score for pain (0-10), the effect of pain on weight-bearing activities (0-30), and difficulty and / or function-related stairs use, including lying on the symptomatic side (0-10), climbing ramps (0-10), standing up without sitting (0-10), home or garden work (0-10) and regular exercise (0-10), physical activity and sports participation (0-10) are evaluated. The study is planned with 40 individuals with gluteal tendinopathy. After questioning the sociodemographic characteristics of the individuals, the patients will be asked to fill in VISA-G, Short Form-36, International Physical Activity Questionnaire, Numeric Rating Scale, Oswestry Disability Index, Oxford Hip Score and modified Harris Hip Score.Test-retest will be re-applied to those of the same individuals who can be reached after 1 week. The results will be analyzed using the SPSS version 22.0 computer package program.

Eligibility Criteria:
Inclusion Criteria:

* Trochanteric bursitis and/or gluteal tendinopathy,
* Lateral hip pain,
* Pain on palpation of the greater trochanter,
* History of pain when lying on the ipsilateral side or during weight-bearing activities, aggravated by activity for more than 3 months.

Exclusion Criteria:

* Hip osteoarthritis,
* Systemic inflammatory disease such as rheumatoid arthritis,
* Lumbar spine nerve root findings,
* History of lumbar spine or ipsilateral hip joint surgery,
* Osteogenic disease such as Paget's disease,
* Corticosteroid injection to the ipsilateral hip in the past 3 months,
* Hip surgery.
A Study of Tarceva (Erlotinib) or Placebo in Combination With Platinum-Based Therapy as First Line Treatment in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

This 2 arm study will compare the efficacy and safety of sequential treatment with Tarceva or placebo, plus platinum-based therapy, as first line treatment in patients with advanced or recurrent non-small cell lung cancer. Patients will be randomized to receive gemcitabine (1250mg/m2 iv) on days 1 and 8, and cisplatin (75mg/m2) or carboplatin (5xAUC)on day 1, followed by Tarceva 150mg/day or placebo from day 15 to day 28 of each 4 week cycle for a total of 6 cycles,then followed by Tarceva or placebo monotherapy.The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* advanced (stage IIIB/IV)non-small cell lung cancer;
* measurable disease;
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.

Exclusion Criteria:

* prior exposure to agents directed at the HER axis;
* prior chemotherapy or systemic anti-tumor therapy after advanced disease;
* unstable systemic disease;
* any other malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix;
* brain metastasis or spinal cord compression.
Clinical Use and Safety of the Fentanyl Transdermal Therapeutic System (TTS) in the Management of Pain in Patients With Cancer

The purpose of this study is to establish the clinical utility and safety of fentanyl TTS (a transdermal patch delivering the narcotic pain reliever fentanyl) in the treatment of pain in patients with cancer.

This is a single-arm, non-randomized, open-label, multi-center trial to assess the safety and clinical utility of the fentanyl Transdermal Therapeutic System (TTS) for the treatment of pain in patients with cancer. Patients requiring narcotics for pain management are converted from conventional analgesics to oral morphine, and titrated to a stable dose prior to the initiation of fentanyl TTS. The stabilized morphine dose provides the basis for the calculation of the equi-analgesic dose of fentanyl TTS based on established analgesic potency ratios. Patients replace the fentanyl TTS patch every 3 days. Immediate-release morphine is available as rescue medication for breakthrough pain. The adequacy of analgesia, use of morphine rescue medication, and routine safety evaluations are obtained at scheduled intervals throughout the trial.

fentanyl patch

Eligibility Criteria:
Inclusion Criteria:

* Patients currently taking narcotic analgesics for relief of cancer pain
* Able to communicate effectively
* Living with a constant caretaker
* Who have achieved a stabilized morphine dose that provides adequate pain control

Exclusion Criteria:

* Patients with a life expectancy of less than 30 days
* Having history of carbon dioxide (CO2) retention or other cardiac, respiratory or nervous system disease (precludes participation because of the potential for respiratory depression)
* Has severe renal or hepatic insufficiency, active skin disease, a history of allergic reactions to narcotics, or a history of narcotic abuse prior to treatment with narcotics for cancer-related pain
* Has a mental or psychiatric disease
* If female of child-bearing potential, currently pregnant or not practicing an acceptable method contraception
Evaluating Illustrated Vs. Traditional Pamphlets for Enhancing Self-Care in Radiation Therapy Patients

This quasi-experimental study utilized a pre- and post-test design with experimental and control groups to assess the effectiveness of optimized illustrated educational pamphlets in enhancing patient self-care cognition, satisfaction, and reducing anxiety. The experimental group received pamphlets with a combination of images and highlighted text, while the control group received traditional text-based pamphlets. The study targeted patients undergoing radiation therapy (RT) for head and neck or breast cancer for the first time. Pre-tests assessed baseline self-care cognition, and post-tests were conducted two weeks after treatment completion. The primary objective was to improve patient awareness and understanding of self-care, aiming to support both mental and physical well-being during RT.

This quasi-experimental, pre- and post-test comparison study was conducted from November 2, 2023, to August 31, 2024, at a medical center in Central Taiwan, following Institutional Review Board approval (IRB No. CS2-23058). A total of 200 first-time RT patients with head and neck or breast cancer were enrolled and randomized into two groups of 100 patients each. The experimental group received optimized illustrated pamphlets covering essential RT information, common side effects, and self-care principles, while the control group received traditional text-based pamphlets.

Eligibility Criteria:
Inclusion Criteria:

* participants with clear consciousness.
* participants could understand and comprehend Mandarin Chinese.

Exclusion Criteria:

* participants with impaired consciousness or decreased cognitive abilities.
Effect of Orthopedic Blocking on Cervical Spine Flexion and Extension Strength

A few studies concerning the effects of joint manipulation have shown muscle responses distal to the site of manipulation. The purpose of this study is to determine if pelvic orthopedic blocking, a low force method of manipulating the sacroiliac joint, can have produce changes to cervical spine function.

All mechanoreceptor types are found in diarthrodial joints. Mechanoreceptor afferents have reflexive connections to motor neurons. Stimulation of muscle and joint afferents are known to produce reflexive muscle changes. Orthopedic blocking applies a gentle compression to the sacroiliac joints. The current study seeks to determine if orthopedic blocking of the sacroiliac joint can affect cervical spine function thereby serving as a useful adjunctive procedure in the treatment of cervical spine joint dysfunction. The current study will compare pre \& post treatment cervical isometric strength readings from an orthopedic blocking group, a trochanter belt group (another type of compression), and a sham group.

Eligibility Criteria:
Inclusion Criteria:

* Logan faculty, students, or staff 18-30 years of age with a leg-length inequality of 5mm or more.

Exclusion Criteria:

* Fractures
* Tumors
* Myopathies
* Consumption of prescription drugs that affect nervous system function
* Recent cervical spine injuries or surgeries
* Cervical pain
Mind-Body Program for Cancer Patients

The purpose of this study is to find out if Mind-Body groups can help improve the physical and emotional well-being of people facing cancer or its treatment.

Pain, fatigue, anxiety, depression, nausea, sexual impairment, body image disturbance, relationship strains, existential distress and role losses are all potential "side-effects" of living with cancer and its treatment. Behavioral interventions have shown some success in mitigating distress and QOL impairment among cancer patients. The purpose of this randomized-controlled study is to compare the effects of Mind-body group interventions on the quality of life of patients with advanced cancer. Patients are randomized to one of two psychotherapy groups, which occur weekly for eight weeks. Quality of life assessments are conducted at baseline and two and four-month intervals.

Eligibility Criteria:
Inclusion Criteria:

* On Active Treatment for:

Breast Cancer Stage IV, Colorectal Cancer Stage IV, Lung Cancer Stages III \& IV, or All Other Cancers (ANY stage on treatment)

* Language is English or Spanish

Exclusion Criteria:

* Patient is currently attending other support/psychotherapy group
* Significant Cognitive Impairment
* ECOG performance status = 3 or 4
* Current major untreated psychiatric disorder
* Unable to attend intervention in following 8 weeks due to medical or practical restrictions
The Effect of Simple Needle Guide Device for Ultrasound-guided Internal Jugular Vein Catheterization in Surgical Patients: a Randomized-controlled Trial

The purpose of this study is to evaluate the effect of simple needle guide device for ultrasound-guided internal jugular vein catheterization in surgical patients


Eligibility Criteria:
Inclusion Criteria:

1. adult ( ≧19 years old)
2. patients undergoing elective surgery

Exclusion Criteria:

1. emergency surgery
2. patients under cervical immobilization
3. anatomical abnormality for Right internal jugular vein catheterization
4. infection or hematoma at puncture site
5. patients who did not need internal jugular vein catheterization
Arthroscopic Rotator Cuff Tear Repair: Single Versus Double Layer Fixation

Retear rates after arthroscopic rotator cuff repairs remain unsatisfactorily high. Recently, attention has been paid to restore the rotator cuff's native anatomy by reconstructing the superior joint capsule. However, the debate whether to reconstruct only the superficial tendinous part or also the deeper capsulo-ligamentous part of the rotator cuff is ongoing. Thus, the intention of the present study is to compare double-layer versus single-layer arthroscopic rotator cuff repair regarding retear rate and clinical outcome.


Eligibility Criteria:
Inclusion Criteria:

* patients with repairable supra- and infraspinatus tears scheduled for arthroscopic rotator cuff fixation
* tear size of at least 2.5 cm and up to 4.0 cm
* signed informed consent

Exclusion Criteria:

* axillary nerve palsy