cyrilzakka/clinical-trials huggingface dataset:
Prophylactic Peripheral Iridectomy Prevents Aphakic Angle-closure Glaucoma

This is a retrospective, nonrandomized comparative trial with historical control to investigate the safety and efficacy of a novel progressive grasping peripheral iridectomy (PGPI) surgical method in preventing aphakic angle-closure glaucoma (AACG) following congenital cataract surgery.

Aphakic angle-closure glaucoma (AACG) following congenital cataract surgery is a common and serious complication which can be prevented by prophylactic peripheral iridectomy (PPI). However, it is difficult to perform routine PPI via scleral tunnel incision especially when the pupil is dilated. Here, the investigators designed a novel progressive grasping peripheral iridectomy (PGPI) surgical method which can ensure the accurate iridectomy position and minimize the complication. The aim of this study is to assess the safety and efficacy of the PGPI in preventing AACG following congenital cataract surgery.

This is a retrospective, nonrandomized comparative trial with historical control. The congenital cataract patients performed with cataract extraction combined with PPI (PPI group) and the patients performed with cataract extraction alone and leaving the iris intact (historical control group) were enrolled and a retrospective medical chart review was conducted. The IOP, anterior chamber depth, corneal clarity, patency of peripheral iridectomy opening, and the rate of AACG, iris posterior synechia (IPS) and visual axis opacity (VAO) were compared between two groups.

Eligibility Criteria:
Inclusion Criteria:

1. patients less than 2 years old;
2. patients performed with congenital cataract surgery with or without PPI;
3. patients with routine follow-up at ZOC.

Exclusion Criteria:

1. patients with IOP ≥21 mm Hg or with congenital glaucoma or with a family history of glaucoma;
2. patients with keratopathy, retinopathy, ocular trauma, radiation therapy or intraocular surgery;
3. patients associated with other congenital ocular anomalies, such as anterior segment dysgenesis, microcornea/microphthalmia, persistent fetal vasculature, lens dislocation and iridocoloboma;
4. patients with systemic diseases, such as Down's syndrome, Lowe syndrome, Stickler syndrome, maternal rubella syndrome or trisomy 13.
Timing of Surgery and Chemotherapy in Treating Patients With Newly Diagnosed Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed; giving chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether giving chemotherapy before and after surgery is more effective than giving chemotherapy after surgery in treating ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer.

PURPOSE: This randomized phase II/III trial is studying how well giving chemotherapy before and after surgery works and compares it to giving chemotherapy after surgery alone in treating patients with newly diagnosed advanced ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer.

OBJECTIVES:

* Determine the feasibility of a randomized trial to determine the impact of the timing of surgery and chemotherapy in patients with newly diagnosed advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer.

OUTLINE: This is a randomized, pilot, multicenter study. Patients are randomized to 1 of 2 treatment arms.

* Arm I (primary surgery): Patients undergo radical surgery. Within 6 weeks after primary surgery, patients receive chemotherapy comprising carboplatin alone or in combination with paclitaxel or another chemotherapy agent on day 1. Chemotherapy repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo interval debulking surgery after the third course of chemotherapy.
* Arm II (neoadjuvant chemotherapy): Patients receive chemotherapy as in arm I for 3 courses. Within 3 weeks after chemotherapy, patients undergo radical surgery. Within 6 weeks after surgery, patients receive an additional 3 courses of chemotherapy as in arm I.

Patients are followed at 9 months after randomization, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 100-150 patients will be accrued for this study within 18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Newly diagnosed advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer
* Clinical and imaging evidence of a pelvic mass with extrapelvic metastases within the past 4 weeks
* Serum CA 125/CEA ratio \> 25
* Plans to receive carboplatin-based chemotherapy

PATIENT CHARACTERISTICS:

Age

* Adult

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* Considered fit to undergo protocol treatment and follow-up
* No other prior or concurrent malignancy that would preclude study treatment or comparisons

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* See Disease Characteristics

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
Insomnia in Primary Care

The goal of this clinical trial is to learn if training primary care providers on treatment of insomnia can improve insomnia symptoms in patients. Researchers will compare insomnia symptoms of patients receiving care from trained practices with patients receiving care from control practices (providing care-as-usual), to see if the training helps to provide improved insomnia care. Participants will be asked to complete four questionnaires and some participants will be invited for an insomnia consultation in primary care by their primary care providers (PCP).


Eligibility Criteria:
Inclusion criteria for a patient to be eligible to participate in this study:

1. Patient registered with a participating primary care facility and willing to provide informed consent AND
2. Survey confirmed presence of insomnia symptoms at least 3 times a week during at least the last 3 weeks AND
3. Survey shown increased score on the Insomnia Severity Index (ISI ≥ 11) AND
4. Survey shown interference with daily functioning on the Insomnia Severity Scale.

Exclusion criteria:

Patients meeting any of the following criteria in the survey will be excluded from participation in this study:

1. Shift work for individuals awakening outside the hours 4:00 A.M. and 10:00 A.M. or going to bed outside the hours of 8:00 P.M. and 2:00 A.M. more than twice a week
2. Other sleep-wake disorders including chronic obstructive sleep apnea, bruxism and narcolepsy, restless leg syndrome and parasomnia.
3. Current pregnancy
4. Presence of epilepsy, schizophrenia, bipolar disorder, post-traumatic stress disorder or dementia in medical history
The Stress Reduction Intervention Study

The primary purpose of the present study is to investigate the relationship between mindfulness and stress habituation. The investigators propose to measure the effect of mindfulness on stress habituation by randomly assigning participants to a 6-week mindfulness-based stress reduction group intervention, a cognitive-behavioral skills group comparison intervention, or a waitlist control condition followed by repeated acute psychosocial stress testing (2 laboratory sessions on 2 separate days). Saliva will be collected from participants throughout both laboratory testing sessions to measure HPA axis activation (an essential stress-responsive system), along with other measures of physiological and psychological stress (e.g., heart rate, blood pressure, emotions). Mediators and moderators of treatment outcome will be examined. The cognitive-behavioral skills group condition is an appropriate comparison group due to the well-documented efficacy of cognitive-behavioral interventions on stress.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking adults who are between the ages of 18-50, who are in general good health
* Perceived stress scores (PSS) \> 3 on a screening survey

Exclusion Criteria:

* reported previous completion of a Mindfulness-Based Stress Reduction or Cognitive Behavioral Therapy program.
* reported pregnancy
* reported use of steroid medication
* presence of a major psychiatric or endocrine disorder (e.g., Major Depression, Cushings Disease; self-reported)
* reported regular wake time after 10:00 AM on a weekday
Physiotherapy, Nutritional Supplement and Anabolic Steroids in Rehabilitation of Patients With Hip Fracture.

This pilot trial investigates the preliminary effect and safety of a 12 week multi-modal intervention initiated during admission in the acute ward after hip fracture surgery. The intervention under investigation is a combination therapy consisting of physiotherapy, protein-rich nutritional supplement and nandrolone decanoate (Deca-Durabolin) supplement. The investigators expect the combination therapy to be a preliminary effective and safe treatment in elderly patients with hip fracture and that this combination therapy intervention program is more efficacious in improving muscle strength, and physical function 14 weeks after hip fracture surgery, compared to physiotherapy, protein-rich nutritional supplement plus placebo.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone surgery for a hip fracture at Amager-Hvidovre University Hospital and admitted at the Hip Fracture Unit at the hospital
* Age \>=60 years
* Ability to speak and understand Danish and with a Danish Social Security Number
* Able to give written informed consent
* Residing at home and with an independent pre-fracture indoor walking ability (NMS≥2)

Exclusion Criteria:

* Postoperative weight-bearing restrictions
* Multiple fractures
* Active cancer or suspected pathological fracture
* Patients unable/unwilling to cooperate to testing and rehabilitation
* Planned/elective hospitalization within the trial period.
* Cognitive dysfunction determined by chart review, reported by nursing staff, or observed by trained research staff (disoriented, dementia, active delirium)
* Uncontrolled blood pressure (systolic \> 150 mmHg, or diastolic \> 100 mmHg)
* Heart disease in the form of peri-, myo- or endocarditis.
* History of stroke with motor disability.
* Heart failure (NYHA class III and IV)
* Evidence of kidney failure or renal impairment (estimated glomerular filtration rate \< 30 mL/min/1.73 m2 or serum creatinine \>200μmol/L)
* Abnormal liver function tests (alanine aminotransferase, γ-glutamyltransferase, bilirubin, or alkaline phosphatase \>2 times the upper limit of normal) or history of hepatic tumor.
* Elevated hematocrit ≥ 50%
* History of breast or prostate cancer
* Abnormally elevated serum PSA assesed at the 3 week control corresponding to PSA \< 4.0 µg/L (60-70 years), PSA \< 5.0 µg/L (\>70 years).
* Allergic to any ingredient in the Deca-Durabolin solution (Nandrolone, benzyl alcohol, arachis oil (peanut-oil) and allergy to peanuts or soya) or milk protein allergy (related to the nutritional drink).
Role of Biomarkers to Screen for Obstructive Sleep Apnea

assess the relationship between obstructive sleep apnea and endocrine, inflammatory, and metabolic bio-markers in consecutively enrolled adult male patients with a clinical suspicion of obstructive sleep apnea.

Obstructive sleep apnea (OSA) is a disorder with high prevalence, estimated to occur in 34% of men and 17% of women , afflicting more than 100 million adults worldwide.

OSA is the third most common serious respiratory condition after Asthma and COPD.

Patients with untreated OSA are at increased risk for hypertension, cardiovascular disease, heart failure, stroke, obesity, metabolic dysregulation, diabetes mellitus, daytime sleepiness, depression, accidents and are a significant burden on the healthcare system.

Unfortunately, up to 90% of individuals with OSA remain without a diagnosis or therapy.

The association between OSA and adverse health consequences has led the American Heart Association and others to suggest that OSA screening be integrated into routine clinical care.

Current tools for OSA screening rely on questionnaires with low diagnostic accuracy from low-quality studies, as reported in meta-analyses, OSA screening measures that are frequently used include the Epworth Sleepiness Scale (ESS) and STOP-Bang questionnaires.

The ESS assesses subjective daytime sleepiness but is nonspecific for OSA, was not designed nor validated for OSA screening.

The recent American Academy of Sleep Medicine (AASM) clinical practice guidelines report that more accurate and user-friendly screening tools, such as blood bio-markers, are needed to better predict OSA diagnosis and severity, a recent review of potential OSA bio-markers concludes that an optimal screening test should be clinically sensitive, specific, simple, timely, inexpensive, and correlate to disease severity.

Furthermore, bio-markers should make pathophysiological sense, reflecting functional changes that accompany OSA.

Numerous individual OSA blood bio-markers have been studied previously dysfunctions in metabolic and endocrine systems induced by OSA, chronic inflammation, hypoxemia, sleep fragmentation, and stress are associated with alterations in bio-markers. These bio-markers include glycated hemoglobin (HbA1c), C-reactive protein (CRP), erythropoietin (EPO), and uric acid,Unfortunately, the diagnostic utility of individual bio-markers or combinations of markers is inconclusive in identifying OSA.

Eligibility Criteria:
Inclusion Criteria:

* All patients with a clinical suspicion of obstructive sleep apnea enrolled to the investigator's chest department.

Exclusion Criteria:

* Patients who previously treated as obstructive sleep apnea, or receiving opioid pain medications.
Prospective Performance Analysis of the Exair(TM) Prolapse Repair System in the Treatment of Pelvic Organ Prolapse

The aim of the study was to assess the role of the Exair transvaginal mesh system to correct pelvic organ prolapse from a subjective and objective standpoint. Subjects treated with the Exair transvaginal mesh for prolapse between June 2013 and August 2015 was analyzed. Subjects with uterine prolapse underwent vaginal mesh hysteropexy. There were no hysterectomies done for uterine prolapse in this study. A composite score that included subjective criteria of absence of a bothersome bulge, no prolapse below the hymen and no retreatment was used to assess success.Transvaginal Exair mesh hysteropexy offers a good option for the management of large uterine prolapses precluding the need for a hysterectomy.


Eligibility Criteria:
Inclusion Criteria:

* subjects desiring surgery for stage II or greater prolapse on the Pelvic Organ Prolapse Quantification System Assessment (POP-Q) and symptoms specific to pelvic organ prolapse mainly bothersome perception of a vaginal bulge

Exclusion Criteria:

* any physical or mental limitation that precluded their participation or inability to give informed consent
Protein Expression in Samples From Young Patients With Rhabdomyosarcoma

RATIONALE: Studying tissue samples from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer.

PURPOSE: This research trial studies protein expression in samples from young patients with rhabdomyosarcoma.

OBJECTIVES:

* To measure the protein expression of candidate proteins in human rhabdomyosarcoma (RMS) tumor samples.

OUTLINE: Archived tumor tissue samples are analyzed for protein expression (i.e., Notch1, Hey1, FGFR4, and Sp1) by IHC techniques and standard commercially available antibodies. Candidate proteins are then correlated with each patient age, gender, rhabdomyosarcoma (RMS) tumor stage, and RMS tumor subtype.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Tumor tissue samples from children with rhabdomyosarcoma (RMS) enrolled in the Children's Oncology Group clinical trials

  * Alveolar rhabdomyosarcoma (ARMS)
  * Embryonal rhabdomyosarcoma (ERMS)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
STRIVE - Resilience Curriculum for Novice Physicians-In-Training

The goal of this trial is to compare self-reported resilience scores in junior physicians-in-training after completion of formal resilience training. The main questions this trial aims to answer are:

* Does formal resilience training improve self-reported resilience scores?
* Does the timing of resilience training (i.e., first vs second year of residency training) impact the effect of training? All participants will be provided with resources on resilience and learner support as per usual institutional practice. The intervention group will also participate in a formal resilience training program.

Researchers will compare self-reported resilience scores 3 months after training to determine the effect of the training program.

Physician wellness has gained much attention over recent years due to growing concerns regarding mental illness and burnout. The COVID-19 pandemic further highlighted the importance of physician health.

Resilience, defined as the capacity of an individual to adapt well and even thrive in the setting of adversity and stress, has been identified as an indicator of physician wellness. Resilience is a multidimensional concept that integrates personal factors, such as personality, with previous challenging experiences, leading to positive adaptation.

Simulation Training for Resilience in Various Environments (STRIVE) is an adaptation of a formal resilience curriculum developed by the Department of National Defense in Canada for military personnel. Fundamental skills learned during the course are applied and reinforced through experiential learning with high-fidelity simulation accompanied by effective debriefing.

Physicians-in-training have been identified as a population cohort with a high prevalence of burnout, depersonalization, and fatigue. Research demonstrates that institutional culture on wellbeing has a greater impact on resident satisfaction compared to the area of specialization. Therefore, we propose that institutional curricula and training in physician wellness may improve self-reported resilience in physicians-in-training.

The study will be conducted at London Health Sciences Centre, University Hospital in London, Ontario. A total of 60 participants will be recruited from the PGY-1 and PGY-2 residents from the Anesthesia and Emergency Medicine residency programs at the commencement of the academic year 2023.

The study aims to compare self-reported resilience of participants before and after the training, to determine if there is a statistically significant improvement in resilience scores, based on the CD-RISC-10 scores at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* All first- and second-year medical residents enrolled in the Schulich School of Medicine \& Dentistry Anesthesia and Emergency Medicine postgraduate residency programs will be eligible to participate, regardless of age, gender, health status, or race. The respective residency program directors have approved study content and procedure.

Exclusion Criteria:

* None
Impact of Hepatitis B Virus on Inflammatory Bowel Disease

The goal of this observational retrospective study is to assess the impact of hepatitis B virus (HBV) infection on the clinical course and outcomes of inflammatory bowel disease (IBD) in Egyptian patients.

Researchers will compare the IBD extent, location, severity, and behavior between IBD patients with and without HBV infection.

Participants will be subjected to history-taking (history of hospital admission and disease flare, surgical history, medication history, follow-up duration, and mortality), clinical examination, laboratory investigations, abdominal ultrasonography, and endoscopic examination.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients older than 18 years.
* Patients with IBD are diagnosed by clinical, radiological, endoscopic, and histological criteria.

Exclusion Criteria:

* Patients aged \< 18 years
* Unwilling to participate in our study
Beetroot Extract and Its Influence on Cardiovascular and Autonomic Recovery From the Effort in Healthy Males

There is no evidence that beetroot extract (Beta vulgaris L.) is advantageous for the recovery of cardiovascular parameters and the autonomic nervous system (ANS) after submaximal aerobic exercise. The objective of this study is to evaluate the effect of beetroot extract supplementation on the recovery of cardiorespiratory and autonomic parameters after a submaximal aerobic exercise session. Healthy male adults will perform a cross-over, randomized, double-blind, and placebo-controlled trial. Beetroot extract (600mg) or placebo (600mg) will be ingested 90 minutes before evaluation in randomized days. Systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse pressure (PP), mean arterial pressure (MAP), heart rate (HR), and HR variability (HRV) indexes will be recorded at Rest and during 60 minutes of recovery from exercise.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males;
* Physically active according to International Physical Activity Questionnaire (IPAQ);
* 18 to 30 old years.

Exclusion Criteria:

* Body mass index BMI \<18.5kg/m² and \>29.9kg/m²;
* Smokers;
* Subjects undergoing pharmacotherapies;
* Musculoskeletal, metabolic, renal diseases;
* Root mean squared standard deviation of R-R intervals \<15 milliseconds.
A Comparison of Peak Aqueous Penetration of Acuvail (Ketorolac 0.45%), Xibrom (Bromfenac 0.09%), and Nevanac (Nepafenac 0.1%)in Patients Undergoing Phacoemulsification

Approximately 126 subjects scheduled to undergo cataract surgery by phacoemulsification, will be randomized in an even allocation (1:1:1) to either Acuvail, Xibrom, or Nevanac. Subjects will be instructed to begin dosing the study medication in the operative eye the day before surgery and continue dosing on the day of surgery. Beginning one hour before surgery, 1 drop of study medication will be instilled by operating room staff approximately every 15 minutes for a total of 3 doses. At the designated time a paracentesis will be performed at the start of the cataract procedure and at least 0.15 cc of aqueous humor will be collected. The sample will be immediately stored on dry ice and shipped to a laboratory for analysis.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be 18 years of age or older.
* Scheduled for cataract surgery by phacoemulsification.
* Subject must be willing to comply with all study requirements and be willing to give informed consent.

Exclusion Criteria:

* Any subject that has a history of uveitis or active iritis.
* Subject can have no previous eye surgery, with the exception of refractive surgery, but not within 6 months.
* No ocular use of prostaglandins within 2 weeks of surgery.
* Use of oral, injectable or topical ophthalmic steroids, nonsteroidal anti-inflammatory (NSAIDS) or immunosuppressants within 14 days prior to surgery.
* Contraindications to NSAIDS.
* Active ocular infection.