cyrilzakka/clinical-trials huggingface dataset:
Dose Ranging Study of Combined Haemophilus Influenzae Type B-Meningococcal Serogroups CY (Hib-MenCY-TT) Vaccine

This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine compared to 2 control groups receiving licensed meningococcal serogroup C conjugate vaccine and/or licensed Hib conjugate vaccine administered at 2, 4, and 6 months of age. Antibody persistence and immune responses to polysaccharide vaccine boosters were additionally assessed at 11 to 14 months of age.


Eligibility Criteria:
Inclusion criteria:

* A male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination.
* Written informed consent obtained from the parent or guardian of the subject.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* Vaccinated against hepatitis B at birth.
* Born after a gestation period of 36 - 42 weeks.

Exclusion criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth
* Any chronic drug therapy to be continued during the study period.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the first dose of vaccine(s).
* Previous vaccination against diphtheria, tetanus, pertussis, polio, N. meningitidis of serogroups C and Y, Haemophilus influenzae type b or Streptococcus pneumoniae.
* History of or known exposure to diphtheria, tetanus, pertussis, polio, or invasive diseases due to N. meningitidis of serogroups C and Y, Haemophilus influenzae type b or Streptococcus pneumoniae.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* A family history of congenital or hereditary immunodeficiency.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures.
* Acute disease at the time of enrolment.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Nurse-led Integrated Care in COPD Patients With a Pulmonary Exacerbation

The aim of the study is to evaluate the effect and effectiveness of the nurse-led integrated care programme for the management of COPD (Chronic Obstructive Pulmonary Disease) exacerbations on patients' quality of life, rehospitalisation and exacerbation rate, illness-related emotional distress, selected health behaviours and cost-utility at three months. Furthermore, understanding barriers and facilitators to implementation success is of interest.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a confirmed diagnosis of COPD (GOLD 1-4)
* Hospitalisation due to a COPD exacerbation and decision to start with steroids and/or antibiotics (severe exacerbation)
* Age ≥ 18

Exclusion Criteria:

* Cognitive impairment (dementia, delirium)
* Not speaking German, French, Italian, English, Spanish, Portuguese, Serbian, Tamil, Hindi, Turkish or Slovakian
Trier Social Stress Test in Virtual Reality

Background The Trier Social Stress Test (TSST) is a valid and gold standard way for inducing psychosocial stress and is widely used in research and diagnostics. One of the downsides of the TSST is the difficulty to maintain the same experimental conditions repeatedly. A TSST in virtual reality (TSST-VR) is constant and requires far less time and personnel. Our TSST-VR version consist of three stress levels (no stress, moderate stress, high stress), a novelty in this field.

Aim The aim is to investigate whether there is a statistically significantly greater increase directly after the TSST-VR in psychological and physiological stress parameters in the moderate and high stress levels compared to the no stress condition (control).

Method A randomized controlled trial is conducted in healthy adults, with the three stress levels as conditions. Cortisol and questionnaires on anxiety and physical arousal are measured at baseline, during and after the TSST. Heart rate is measured continuously and adverse events are monitored.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants, not having a psychiatric diagnosis in the last three years or currently having an endocrine disorders
* Aged between 18 and 65 years
* Good understanding of the Dutch language
* Normal or corrected-to-normal vision and hearing

Exclusion Criteria:

* History of photosensitive epilepsy
* Hearing loss
* Pregnant woman
* Women who breastfeed
* Taking heart rate altering medication such as beta-blockers.

Pregnant woman and woman who breastfeed are excluded because they have a different hormone levels which can intervene with the stress reaction.
Evaluation of Extended Tear Film Break Up Time (TFBUT) With an Ocular Emulsion

The primary objective of this investigation will be to quantify the increase in tear film break-up time (TFBUT) associated with the instillation of a single eyedrop of an Ocular Emulsion in dry eye sufferers.

The secondary objective of this investigation will be to compare the tear film break up time measured with two different techniques.

Eligibility Criteria:
Inclusion Criteria:

1. The subject must be 18 years of age or older;
2. The subject must have a best corrected visual acuity of 0.6 LogMAR (\~6/24) or better in each eye
3. The subject must not have used any topical ocular drops for approximately 24 hours prior to the enrolment/screening visit
4. The subject must be classified as dry eye at enrolment/screening visit according to the following criteria:

   * Subjects' self-assessment of dry eye status (answer of at least "some of the time" to the question, "How often have your eyes felt dry enough to want to use eye drops?");
   * TFBUT measured with DET ≤ 5 seconds in at least one eye;
   * Grade 1 for meibomian gland expression in both eyes;
   * Evidence of missing meibomian glands in both eyes.

Exclusion Criteria:

1. History or evidence of ocular or intraocular surgery in either eye within the past six months.
2. History or evidence of serious ocular trauma in either eye within the past six months.
3. Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs).
4. History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye.
5. Use of any concomitant topical ocular medications during the study period.
6. Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of either drop under investigation.
7. Participation in an investigational drug or device study within 30 days of entering this study.
Lycopene in Treating Patients With Prostate Cancer or Benign Prostatic Hyperplasia

RATIONALE: Chemoprevention is the use of certain substances to keep cancer from forming, growing, or coming back. Eating a diet high in lycopene, a substance found in tomatoes and tomato products, may keep cancer from forming or growing. Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This randomized clinical trial is studying how well lycopene works in treating patients with prostate cancer or benign prostatic hyperplasia.

OBJECTIVES:

* Assess the ability of prostatic tissue to accumulate doses of lycopene in patients with prostate cancer or benign prostate hyperplasia.
* Determine whether the steady state level of DNA oxidation in blood and prostate tissue is responsive to lycopene dosing.
* Investigate the effect of lycopene dosing on the lipid peroxidation marker malondialdehyde in serum.
* Assess the importance of measuring multiple DNA oxidation products as biomarkers of oxidative stress and its chemoprevention.
* Determine the significance of DNA oxidation products in blood as an indicator of oxidative stress in the prostate.
* Measure prostate and blood uptake of the chemoprevention agent lycopene.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral lycopene once daily for 3 weeks.
* Arm II: Patients receive oral placebo once daily for 3 weeks. In both arms, patients undergo biopsy to confirm diagnosis of prostate cancer or benign prostatic hyperplasia after 3 weeks of study therapy.

Blood samples are collected at baseline and before surgery for biomarker/laboratory studies.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of 1 of the following:

  * Prostate cancer
  * Benign prostate hyperplasia
* High blood levels of prostate-specific antigen
* Enlarged prostate

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Electric and Manual Toothbrushes in Nursing Homes

Effect of electric toothbrush on oral hygiene in nursing home residents tested I randomized clinical trial for 2 months and followed up 12 months after baseline

Patients in nursing homes often have many natural teeth with exposed root surfaces, bifurcations, a complexity of dental restorations like partial prostheses, bridges/crowns, fillings and implants. In addition they have a limited physical ability, like reduced muscular strength, rigidness in the neck and spine. All these factors contribute to make it difficult, both for themselves and their nursing staff to maintain good oral hygiene.

Electrical toothbrushes have been proved effective in removal of dental plaque. There have also been reports from nursing homes that approves of electrical toothbrushes as a helpful aid among the nursing staff.

The present study examine if the overall oral hygiene actually improves with the use of electric toothbrush.

Material and method: The study is a randomized clinical trial (RCT) that includes patients from nursing homes in Oslo. The recording dentist is blind to the type of tooth brush Inclusion criteria.

* Patients living in nursing home in Oslo
* Provide written informed consent prior to enrolment (from relatives when patients were assessed by physician to be without ability to give written consent.

Participants in the experimental group use an electrical toothbrush. Participants in the control group use a standard manual toothbrush.

Registration of oral hygiene and plaque score at baseline 0 and after 2 months intervention.

After the RCT trial the participants were free to choose toothbrush, electric or manual. The study includes a follow-up study 10 months after the end of the RCT trial.

The study is a part of the PhD programme for Katrine Gahre Fjeld Cand. Odont.

Supervisors:

Tiril Willumsen Dr Odont, The Dental Faculty, University of Oslo Hilde Eide Dr. Philos, Department of Nursing, Buskerud University College Morten Mowe Dr med, The Medical Faculty, University of Oslo

Eligibility Criteria:
Inclusion Criteria:

* Patients living in nursing home in Oslo
* Provide written informed consent prior to enrolment (from relatives when patients were assessed by physician to be without ability to give written consent.

Exclusion Criteria:

* Patients too weak to be examined
* Patients With life expectancy less then one year
Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine for Overactive Bladder (OAB)

To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder


Eligibility Criteria:
Inclusion Criteria:

* Adult overactive bladder (OAB) patients who present with OAB symptoms, including urinary frequency \>= 8 per day and urgency urinary incontinence \>=1 per day

Exclusion Criteria:

* Patients with conditions that would contraindicate for fesoterodine use, e.g, hypersensitivity to the active substance (fesoterodine) or to peanut or soya or any of the excipients, urinary retention, and gastric retention.
* Patients with significant hepatic and renal disease or other significant unstable diseases.
* OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
Low-dose Spinal Morphine for Post-Thoracotomy Pain After Video-Assisted Thoracoscopic Surgery

One-thirds of patients underwent video-assisted thorascopic surgery still have severe pain. Therefore we want to demonstrate weather 0.15 mg spinal morphine would reduce 24 hour postoperative requirement comparing to control group.


Eligibility Criteria:
Inclusion Criteria:

* ASA (American Society of Anesthesiologist) physical status I to III,
* Undergoing elective video-assisted thoracoscopic surgery at Siriraj and Thammasart Hospitals
* capable of using a patient-controlled analgesia (PCA) machine
* understanding the numeric rating scale (NRS) score for pain assessment.

Exclusion Criteria:

* history of allergy to the study drugs
* bleeding disorder
* infection of the back
* refusing spinal anesthesia
* history of cerebrovascular disease
* using postoperative ventilator support were excluded
A Study of Stereotactic Radiosurgery (SRS) to Treat Pain in the Chest and/or Stomach Wall

The researchers are doing this study to find out whether stereotactic radiosurgery (SRS) is a safe, practical (feasible), and effective treatment for people with chronic TAWP. The researchers will test different doses of SRS to find the highest dose that causes few or mild side effects.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have a documented history of chronic (≥ 3 months) thoracoabdominal wall pain (TAWP) attributable to ≤ 3 unilateral spinal levels as confirmed by diagnostic paravertebral nerve block or TENS (if results of the paravertebral nerve block are inconclusive) performed by an attending anesthesiologist specializing in pain management prior to study enrollment.
* Patients must have TAWP that is inadequately relieved by a trial of conventional pharmacologic therapy (defined as NRS pain score ≥ 4/10 while on treatment with conventional pharmacologic therapy for analgesia) as determined by an attending physician specializing in pain management.
* KPS ≥ 60%
* Age ≥ 18 years old

Exclusion Criteria:

* Patients with a life expectancy of \< 6 months as predicted by the Adult Comorbidity Index (ACE-27, see Appendix 1)
* Patients with active autoimmune connective tissue disease
* Patients with bilateral TAWP
* Patients with preexisting pneumothorax
* Patients with preexisting excessive pleural effusion (extending \> 3 vertebral levels)
* Systemic chemotherapy delivered or planned to be delivered within +/- 5 days of SRS
* Unable to undergo a diagnostic paravertebral nerve block
* Unable to undergo at least one of either a myelogram or spine MRI
* Patients for whom external beam treatment plans to deliver the prescription SRS dose to the lesion of interest cannot be safely designed as specified by the Dose Constraint Guidelines in Appendix 2

  * Evaluation of any radiation doses previously delivered to spinal cord/cauda equina and other critical structures (bowel, esophagus, lungs, kidneys, rectum) will be taken into consideration
  * If radiation dose from SRS would exceed any normal tissue constraint as noted in Appendix 2, the patient will be ineligible
* Abnormal complete blood count. Any of the following:

  * Platelet count \< 75 K/µL
  * Hgb level \< 9 g/dl
  * WBC \< 3.5 K/µl
* Abnormal coagulation profile: INR \> 2.5 INR and/or APTT \> 80 seconds. Patients who are on anticoagulation medication that may not be safely held for the myelogram procedure (≥ 5 days for antiplatelet agents and warfarin; ≥ 24 hours for low-molecular weight heparin formulations) will be excluded.
* Allergy to local anesthestics
* Local infection at the site of injection of anesthetic
* Severe spinal deformities with anatomic distortion (severe scoliosis/kyphoscoliosis)
* Severe respiratory disease (i.e. oxygen dependent)
Effects of High-Frequency In Situ Simulation-based Team Training on Clinical Performance During Pediatric Cardiac Arrest

Cardiac arrest in hospitalized children is a rare occurrence in general and for each healthcare professional in particular, making lack of routine in performing cardiopulmonary resuscitation a challenge. Mortality and morbidity following cardiac arrest depend on the technical (medical knowledge, procedures, etc.) and non-technical (team leadership, communication, etc.) skills performed by the medical team. Simulation-based team training is a well-known and effective method to improve team performance in high-stake and time-sensitive situations, without putting actual patients at risk. Unfortunately, studies show that skills obtained during simulation-based team training decline within a few months. However, recent observational studies have demonstrated improved technical pediatric basic life support skills after short simulation sessions with a high frequency of repeat. The healthcare professionals in these studies are limited to selected groups and tests are performed exclusively on skill stations.

In this study, the effects of a novel high-frequency training program will be investigated. A controlled intervention study in two comparable Danish regions will be conducted. Healthcare professionals in four pediatric departments in the intervention region will participate in the high-frequency training program. Healthcare professionals in four pediatric departments in the control region will continue simulation-based team training with no changes - "as usual" and at a two to three times lower frequency (based on unpublished data). Both groups consist of approximately 600 healthcare professionals, contributing to a total of 1,200 participants included in this project.

Hypotheses: high-frequency training will improve primary outcomes during in-situ simulated pediatric in-hospital cardiac arrest as specified:

1. Teamwork competencies measured by the team emergency assessment measure (TEAM),
2. Time (seconds) to recognition of cardiac arrest.
3. Time (seconds) to initiation of cardiopulmonary resuscitation.
4. Longest chest compression pause duration.

Data collection. To assess clinical performance in both regions unannounced in-situ (in own department with usage of own equipment) simulations of pediatric cardiac arrest will be performed and recorded on video.


Eligibility Criteria:
Inclusion Criteria:

* Healthcare professionals (doctor or nurse) employed in one of the eight pediatric departments in Central Denmark Region og Southern Denmark Region during the project period April 1st 2023 to April 1st 2024.

Exclusion Criteria:

* Missing consent to be recorded
Body Weight, Aspirin Dose and Pro-resolving Mediators

This study employs a placebo-controlled randomized cross-over design to investigate the impact of body weight and aspirin dose on levels of specialized pro-resolving lipid mediators in blood and neutrophils.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 40 and 70 years

Exclusion Criteria:

1. Anti-platelet medication use in the past 7 days
2. Aspirin intolerance or allergy
3. Known bleeding or clotting disorder
4. Chronic inflammatory or connective tissue disease
5. Immunological deficiency
6. Diabetes mellitus
7. Prior gastric or bariatric surgery
8. Active smoking
9. Platelet count \<100,000
10. Use of omega-3 fatty acid supplementation
11. Use of drugs or supplements known to inhibit COX-1/COX-2/lipoxygenases
12. Corticosteroid use
13. Recent initiation or change in dose of statin therapy
14. Pregnancy
The Negative Pressure Wound Therapy in Flap Enhancement: Clinical Evaluation Study

The goal of this study is to compare the clinical outcomes of using NPWT dressing versus conventional dressing in improving flaps outcome

The cases will be divided into 3 major study groups:

1st group will be managed with high negative pressure wound therapy The 2nd group will be managed with low negative pressure wound therapy The 3rd group will be managed with conventional dressing

Eligibility Criteria:
Inclusion Criteria:

- Adult patients skin and soft tissue defects that need flap coverage

Exclusion Criteria:

* associated severe regional injuries uncontrolled comorbidities
Amelioration of Adverse Ocular Side Effects of Glaucoma Medications in Glaucoma Patients Using Topical GL101

To evaluate the safety and efficacy of 0.5% GL101 topical gel administered twice daily for 28 days in ameliorating adverse ocular side effects in patients under ongoing treatment with glaucoma medications.

The study is to assess the safety and efficacy of a new treatment for ocular surface disease associated with the use of glaucoma medications.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female of any race, at least 18 years of age at Visit 1 Screening.
2. Has provided verbal and written informed consent.
3. Be able and willing to follow instructions, including participation in all study assessments and visits.
4. Currently being treated for glaucoma using at least two medications, and be willing to continue on the same regime.
5. Suffers from at least two of the symptoms in the GLIA™ Glaucoma Medication Ocular Side Effect Symptoms Questionnaire at a severity of 2 (moderate) or more.
6. If a woman of childbearing potential, have a negative urine pregnancy test at Visit 1 and be using an adequate method of birth control throughout the study period.

Exclusion Criteria:

1. Comorbidity with other severe or chronic eye conditions that in the judgment of the investigator will interfere with study assessments, such as corneal opacities and scars, dystrophies, epithelial scarring, infections, blood clots, etc.
2. Best corrected visual acuity (BCVA) at baseline \<20/200.
3. Has a condition or history that, in the opinion of the investigator, may interfere significantly with the subject's participation in the study.
4. A woman who is pregnant, nursing an infant, or planning a pregnancy.
5. Has a known adverse reaction and/or sensitivity to the study drug or its components.
6. Routine use (more than twice a week) of a chlorinated swimming pool.
7. Unwilling or unable to cease using the following medications during the study period: Topical ocular cyclosporine (e.g. Restasis®), anti-histamines, antipsychotics, or eye gels.
8. Currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to Visit 1.
Metaxa Hospital THromboprophylaxis Program in Oncological & Surgical Patients

During MeTHOS study will be collected Real World Data the clinical practice regarding Thromboprophylaxis in high thrombotic risk solid tumors patients undergoing surgical and /or chemotherapeutical treatment, for one year following the protocol initiation date.

Specifically focus will be on the following:

* Number of thrombotic events
* Anti-thrombotic management dosage \& duration
* Any bleedings related to anticoagulation
* Patients' adherence and compliance


Eligibility Criteria:
Inclusion Criteria:

1. Patients who were diagnosed with histological confirmed high thrombotic risk cancers (GI, thoracic, gynecologic and genitourinary) undergoing surgery
2. Age ≥ 18 years
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
4. Life expectancy \>6 months
5. Signed informed consent

Exclusion Criteria

1. Patients who were not diagnosed with histological confirmed high thrombotic risk cancers (GI, thoracic, gynecologic and genitourinary) undergoing surgery
2. Age \< 18 years
3. ECOG performance status \>2
4. Life expectancy \<6 months
5. Not signed informed consent