cyrilzakka/clinical-trials huggingface dataset:
The Impact of Patient Safety Incidents on Patients' Quality of Life

This study estimates the impact of patient safety events on QoL in elective surgery patients using a secondary data set

Background: The burden of patient safety incidents (PSIs) is often characterised by their impact on mortality, morbidity and treatment costs. Few studies have attempted to estimate the impact of PSIs on patients' health-related quality of life (HRQoL) and the studies that have made such estimates primarily focus on a narrow set of incidents. The aim of this paper is to estimate the impact of PSIs on HRQoL of patients undergoing elective surgery in England.

Materials and Methods: A unique linked longitudinal data set consisting of Patient Reported Outcome Measures (PROMS) for patients with hip and knee replacements linked to Hospital Episode Statistics (HES) collected between 2013/14 and 2016/17 is examined. Patients with any of nine US Agency for Healthcare Research and Quality (AHRQ) PSI indicators are identified. HRQoL is measured using the general EuroQol five dimensions questionnaire (EQ-5D) before and after surgery. Exploiting the longitudinal structure of the data, exact matching combined with difference in differences to estimate the impact of experiencing a PSI on HRQoL and its individual dimensions, comparing HRQoL improvements after surgery in similar patients with and without a PSI.

Eligibility Criteria:
Inclusion Criteria:

* no

Exclusion Criteria:

* Patients for which health related quality of life is not observed both before and after surgery.
Exercise in Health and Chronic Obstructive Pulmonary Disease

The purpose of this study is to find out more about the effects of chronic obstructive pulmonary disease (COPD) on the function of blood vessels, the heart, and muscle at rest and during exercise.

Oxidative stress, defined as an imbalance between pro and antioxidant molecular species in favor of the former, has recently been recognized as a potential mechanism in the peripheral muscle dysfunction associated with COPD. a series of studies are proposed to better understand the role and source of oxidative stress in the skeletal muscle of patients with COPD. Specifically, three main aims will address the following questions regarding COPD, skeletal muscle, and oxidative stress: where is oxidative stress most prevalent, why does oxidative stress occur, and what are the consequences of oxidative stress in COPD? the overall hypothesis to be tested is that COPD results in a shift toward greater intramuscular oxidative stress and this is, at least in part, responsible for the diminished mechanical efficiency and greater peripheral muscle fatiguability during muscular work often associated with this disease. The vascular consequence of this augmented free radical load is altered vascular function and a disruption of the local matching of perfusion and metabolism in skeletal muscle during exercise. These crucial changes result in a cascade of factors such as local hypoxia and elevated vascular shear stress, entering a vicious cycle that leads to the generation of more free radicals, especially during physical work. It is proposed that this imbalance between pro and antioxidant potential, toward oxidative stress, plays a significant role in the attenuated exercise capacity and reduced muscle fatigue resistance associated with COPD.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Obstructive Pulmonary Disease (COPD) patients (over 18 years old) and
* age-matched healthy controls (over 18 years old)

Exclusion Criteria:

* Severe Chronic Obstructive Pulmonary Disease (volume exhaled at the end of the first section of forced expiration is predicted to be under 30 percent),
* Severe Heart Failure
Study of d-MAPPS™ Ophthalmic Solution, Safety, Tolerability, and Efficacy in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGVHD)

A Double-Masked, Randomized, Placebo-Controlled Study of the Safety and Tolerability and Efficacy of d-Mapps™ Opthalmic Solution in the Treatment of Chronic Oscular Graft-Versus-Host Disease (oGHVD)


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Willing and able to provide written informed consent.
* Willing and able to comply with study assessments for the full duration of the study.
* Patients may be using bilateral scleral lenses and/or bilateral punctal plugs at the time of accrual.
* Minimum Oxford Schema grad of ≥ 1 in at least one eye.
* OSDI scored of ≥ 22.
* UNC DEMS score of ≥ 3.
* In good stable overall health.

Exclusion Criteria:

* History of Rheumatoid Arthritis, Lupus, Scleroderma.
* Ocular or periocular malignancy.
* Significant change, as judged by the principal investigator, in systemic immunosuppressive regimen within 2 weeks of study entry.
* Any history of topical tacrolimus use.
* Any change in dosage of tetracycline compounds (tetracycline, doxycycline, and minocycline) within the last month.
* Any change in frequency of preserved anti-glaucoma medications within 2 weeks of study entry.
* Current use of topical steroids more than twice a day.
* Corneal epithelial defect \> 1mm2.
* Any history of herpetic keratitis.
* Participation in another simultaneous medical research study.
* Signs of current infection, including fever and current treatment with antibiotics.
* All vaccination including COVID are prohibited during this study.
* Signs of current infection, including fever and current treatment with antibiotics.
* All vaccinations including COVID are prohibited during this study.
* Intra-ocular surgery or ocular laser surgery within 3 months.
* Women who are pregnant, breastfeeding, or plan to become pregnant while participating in the study. If of childbearing potential, unwillingness to use effective birth control while participating in the study.
* Any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study.
A Trial of an Augmented Exercise Program in the Prevention of Deconditioning Among Survivors of Severe Burns

Burn injuries can affect how well you are able to perform daily activities. The reason this study is being done is to find out if aerobic exercise helps burn patients recover function, strength and stamina.

Participants will come to Johns Hopkins Bayview Medical Center, Burn Rehabilitation Gym for treadmill exercise sessions 3 days per week for 12 weeks. Participants will be tested for strength and stamina before the start of the 12 week program, at the end of the 12 week program, as well as 6 months, 1 year and 2 years after the end of the 12 week program.

Patients who recently suffered a burn injury and who were discharged from the hospital in the past six months may be eligible to participate.


Eligibility Criteria:
Inclusion Criteria:

* Patients who recently suffered a burn injury and who were discharged from the hospital in the past six months may be eligible to participate

Exclusion Criteria:

* History of heart-related health problems
* Foot burns
Correlation of Particulate Matter and Heme Oxygenase-1 Protein Activity in Asthmatic Children by Induced Sputum Analysis.

Samples of sputum from asthmatic children, between 5-17 years, will be collected during two years of the study period to perform tests Particle Size Distribution (PSD) and Shape Analysis (SA) of the particulate matter in the sputum and a biochemical reaction to evaluate the activity of Heme Oxygenase-1 protein in sputum cell supernatants.

Each child will perform Pulmonary Function Testing (PFT) and Induced Sputum (IS) as a routine part of diagnosis of asthma.

Parents will be asked to complete a questionnaire including questions on their child's respiratory symptoms in the last 12 months as well as socioeconomic factors. Parents will be asked to give informed written consent for their child's participation in the study.


Eligibility Criteria:
Inclusion Criteria:

* •All children, between 5-17 years, performing a routine diagnosis of asthma in Tel Aviv Sourasky Medical Center that there parents gave informed written consent for their child's participation in the study.

Exclusion Criteria:

* None.
Use of Low-cost Molecular Diagnostic Techniques as a New Surveillance Model for Diseases Preventable by Vaccinations.

Vaccine-preventable disease (VPD) surveillance should be a priority throughout the world. In Italy, however, there is limited attention to the epidemiology of VPDs, with the consequence that their incidence is largely underestimated. Although notification of vaccine-preventable diseases is mandatory, very often the etiologic agents causing VPDs are not identified the etiological agents causing the major and most severe infectious diseases in childhood. Several reasons underlie the underestimation. For example, not having a good surveillance system does not allow us to organize a sustainable prevention project for example based on on the introduction of new vaccinations. For example the limited use of low-cost high-sensitivity techniques such as real-time PCR, which could, if more widely used, improve pathogen identification with 3 times the sensitivity of standard cultural methods. Therefore, the idea of this multicenter, biological sample study is to take advantage of the regional pediatric network with the goal of improving VPD surveillance and increase awareness of the importance of surveillance of preventable diseases with the vaccine within the pediatric network.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 0-18 years with infectious disease (bacterial or viral) diagnosed by molecular techniques at the AOU Meyer Immunology Laboratory
* Obtaining informed consent

Exclusion Criteria:

* Individuals with concomitant diseases such as cystic fibrosis, known immunodeficiency, or with infection suspected nosocomial (hospitalization or hospital admission within 15 days prior to the onset of symptoms) will be excluded from the study
Study of BC3195 Monotherapy in Patients With Advanced Solid Tumors

This is a phase I study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of BC3195 in Patients with Locally Advanced or Metastatic Solid Tumors.

This is a phase I study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of BC3195 in Patients with Locally Advanced or Metastatic Solid Tumors.

The patients in whom standard treatment has failed (either due to disease progression or intolerance), who meet the criteria will receive BC3195 via intravenous (IV) in 21-day treatment cycles.

A Safety Monitoring Committee (SMC) will be established to decide the dose levels to be administered and dose regimen during dose escalation based on a thorough review of all the safety, PK (if applicable), and other relevant data from the previous dose cohort, and to determine the MTD and the putative RP2D for dose expansion.

Eligibility Criteria:
Inclusion Criteria:

1. Patients voluntarily participate in the study and should provide a written informed consent.
2. Male or female patients ≥ 18 years of age.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Subjects with locally advanced or metastatic solid tumors failed to prior SOCs and no appropriate SOC to treat the current disease per investigator's judgement.
5. Life expectancy ≥ 3 months.
6. Subjects with adequate organ function.
7. Men or women of childbearing potential (which refer to men or women who have not been surgically sterilized and pre-menopausal women) must use a highly effective method of contraception during the study and continue to take contraception measures for 6 months after the last dose of the study drug.

Exclusion Criteria:

1. Pregnant or lactating women.
2. Prior systemic anticancer treatment within 5 half-lives or 4 weeks before the first dose (whichever is shorter).
3. Active viral infection requiring systemic therapy during the screening period.
4. Hypertension that cannot be well-controlled with medical treatment.
5. Cardiovascular disease of clinical significance.
6. Subjects with any active infection that requires anti-infective therapy judged by the investigators.
7. Subjects are not suitable for participating the study judged by the investigators.
8. Subjects with poor compliance, who are unwilling to or unable to follow study procedures.
Pediatric Normative Markerless Movement Analysis

The objective of this project is to collect baseline data from a normative population of children that gender and age matches the population of patients expected to be treated by Mary Bridge Children's Research \& Movement Lab. This project seeks to recruit 20 male and 20 female typically developing individuals, between the ages of 3 and 25 years of age. Non-invasive measurements of movement patterns (motion analysis and force plate data) will be collected during bipedal gait.


Eligibility Criteria:
Inclusion Criteria:

* Age: 3-25 years of age (with 3 and 25 year olds considered for inclusion).
* Ambulate independently and without the use of assistive devices or orthoses.
* Willing and interested in participating.

Exclusion Criteria:

* Neuromuscular disorders such as cerebral palsy, muscular dystrophy, myotonic dystrophy, spinal muscular atrophy, peripheral neuropathy, or other generalized muscle and/or nerve issues.
* Evidence of developmental delays, muscle weakness, decreased muscle tone, joint stiffness, muscle or bone deformity.
* Currently using or has a history of using assistive technology devices, bracing/orthoses, manual or powered mobility equipment.
* History of premature birth.
* Currently or has a history of taking medication or pharmaceutical treatment related to musculoskeletal side-effects/scenario/diagnosis.
Tailored Internet-delivered Cognitive Behaviour Therapy in Primary Care

A tailored Internet-based cognitive-behavioural intervention is tested within a primary care clinic. Weekly measures of symptoms of depression and anxiety are obtained. Significant within-group effects are expected.

This Internet-based cognitive-behavioural therapy intervention contains 8-10 text-based self-help modules in which 4 modules are fixed (the first three and the last) and the rest are "prescribed" following the diagnostic interview. These modules contain material on panic disorder, social phobia, stress management, assertiveness training, concentration, relaxation among other things.

The intervention is tested within a primary care clinic. Weekly measures of symptoms of depression and anxiety are obtained.

Eligibility Criteria:
Inclusion Criteria:

* Symptoms of depression and anxiety

Exclusion Criteria:

* Severe depression (based on interview)
* Severe psychiatric condition (e.g. psychosis or bipolar disorder)
* Suicidal (measured in diagnostic interview)
Trans-inguinal Pre-peritoneal Hernioplasty Versus Lichtnestein's Technique in Inguinal Hernia Repair

Mesh repair of inguinal hernia is the most common operation performed on general surgical patients. Approximately 20 million groin hernioplasties are performed each year worldwide. Countless studies have been reported in the medical literature in attempts to improve the overall outcomes following hernia operations and, due to this fact, the procedure has evolved immensely, especially over the last few decades. Recurrence of inguinal hernia was initially a significant problem. Lichtenstein repair (LR), recurrence rate has consistently been reported as low as 1-4%\[2\], a drop from up to 10%. But increased incidence of chronic groin pain following LR.

Transinguinal preperitoneal (TIPP) inguinal hernia repair with soft mesh has been reported as a safe anterior approach with a preperitoneal mesh position .

Theoretically, TIPP repair may be associated with lesser chronic postoperative pain than Lichtenstein's technique due to the placement of mesh in the preperitoneal space to avoid direct regional nerves dissection and their exposure to bio-reactive synthetic mesh. The placement of mesh in this plane without using any suture for fixation and lack of mesh exposure to regional nerves was assumed to result in the reduced risk of developing chronic groin pain. So aim of our study to prove less hospital stay and complication and cost effectiveness for preperitoneal meshplasty

This study is a prospective randomized study including all Patients with unilateral non complicated inguinal hernia who will undergo hernioplasty in surgery department at AUH during the period from 3- 2018 to 6- 2020

Methodology:

Patients will be classified into two groups according to the surgical procedure performed as follows:

* Group A: Patients undergoing TIPP hernioplasty
* Group B: Patients undergoing lichtnestein's technique hernioplasty

Sample size:15 patients for each group.

D) Exclusion criteria:

1. Patients who were unfit for operation.
2. Patients with bilateral or recurrent inguinal hernia
3. Patients aged below 18 years,
4. Patients undergoing emergency hernia repairs

Eligibility Criteria:
Inclusion Criteria:

* . Patients with unilateral non complicated inguinal hernia who will undergo hernioplasty in surgery department at AUH

Exclusion Criteria:

1. Patients who were unfit for operation.
2. Patients with bilateral or recurrent inguinal hernia
3. Patients aged below 18 years,
4. Patients undergoing emergency hernia repairs
A Study to Evaluate the Incrediwear Products Immediately After ACL Repair

To assess the benefits of using the Incrediwear knee products after ACL or ACL+MCL arthroscopic surgery, on the postoperative pain, range of motion and effusion. The study team will compare patients with Incrediwear products, or placebo Incrediwear products, or no products during the first 6-month postoperative period. The group that does not wear the Incrediwear or placebo products is considered the standard of care control group and will proceed with the normal standard of care compression hose.

After knee surgery, the participant will be randomly assigned to one of the three groups. The participant will have a 1-in-3 chance of being assigned to each group. The products will be placed on the participant by the hospital staff according to the random assignment sent with the surgical packet.

Study Screening/pre-operative appointment

* The surgeon confirms the participant meets the inclusion criteria and are scheduled for surgery in the next few weeks, and how the participant may be eligible to participate in the study.
* The surgeon will discuss the study and possible risks/benefits of being in the research.

  • Day of surgery
* The study packet will be sent to the hospital by the clinical staff. The packet will include a study number assignment, the products assigned the study number, and the patient study journal. The participant, surgeon, and hospital staff will not know which group the participant are in, with the exception of the standard of care control group, as this group will wear the hospital-issued compression hose.

  • Postoperative Recovery
* Subjective: Patient rates surgical site pain, on a 0-10 VAS pain scale. Patients will record pain medication type and quantity taken in a daily pain diary.
* Objective: Surgical extremity range of motion, and surgical extremity knee effusion, measured by either the Physical Therapist or the surgeon at the postop appointment.
* Measurements will be taken at; Preop appointment, Postop Day 0, Day 3, Day 7, Day 14, Day 21, Day 30 (1 month), Day 45, Day 60 (2 month), Day 100 (3 month), and Day 180 (6 month).

Eligibility Criteria:
Inclusion Criteria:

* Consented to protocol
* Compliant protocol
* BMI less than 35
* Undergoing ACL or ACL+MCL within 30 days

Exclusion Criteria:

* Pregnancy
* Rheumatoid Arthritis
* Poorly controlled diabetes (HgA1c \> 7.5)
* Previous blood clots
* BMI greater than 35
* Varicosities on operative leg
* Pain management patient
* Prior knee surgery to the operative / study knee
* Worker's Comp patients
Research Evaluating the Value of Augmenting Medication With Psychotherapy

This 24-week study, with a 12-month follow up period, will compare the effectiveness of antidepressant medication alone to the combination of psychotherapy and antidepressant medication in patients with chronic depression.

Chronic depression affects approximately 5% of adults in the United States and is associated with significant functional impairment and high health care utilization. The combination of drug treatment and psychotherapy may be most effective in treating depression. This study will determine the effects of adjunctive psychotherapy in depressed patients who have failed to respond or have responded only partially to an initial trial medication.

Participants receive an initial trial of antidepressant medication for 8 to 12 weeks. Participants who continue to have depressive symptoms are randomly assigned to add Cognitive Behavioral Analysis System of Psychotherapy (CBASP) or supportive therapy to their medication regimens or to continue pharmacotherapy alone for an additional 12 weeks. Assessments are made at 6 and 12 months post-treatment.

Eligibility Criteria:
Inclusion Criteria

* Major depressive episode
* Depressive symptoms \> 2 years without remission
* Hamilton Depression Scale (HAM-D) score \> 20
* Fluent in English

Exclusion Criteria

* Psychotic disorders, bipolar disorder, post traumatic stress disorder, obsessive compulsive disorder, or eating disorder
* Serious, unstable, or terminal medical condition
* Axis II diagnosis of antisocial, schizotypal, or severe borderline personality disorder
* Previous treatment with CBASP
* Previous ineffective treatment with 4 of the medication treatments used in the study
* Substance abuse
* Pregnancy
* Not willing to end other psychiatric treatment
Thermal Pulsation Versus Warm Compress Treatment for Meibomian Gland Dysfunction

This study aimed to assess the treatment outcome differences between a single, in-office bilateral treatment with the thermal pulsation system and twice-daily, 10-minute applications of the warm compress mask at home for 8 weeks.

This prospective, single-center, single-masked, randomized, controlled clinical trial compared the Systane iLux handheld thermal pulsation system with a warm compress mask (Bruder Moist Heat Eye Compress, Bruder Healthcare, Alpharetta, GA, USA) for the treatment of meibomian gland dysfunction (MGD).

Subjects aged 18 or older were randomized 1:1 to either a single in-office thermal pulsation treatment or twice-daily use of the warm compress mask, with both eyes undergoing the same treatment. Enrollment criteria included Ocular Surface Disease Index (OSDI) score \>23, total meibomian gland secretion (MGS) score \< or =12 in the lower lid of each eye, and tear break-up time (TBUT) \< 10 seconds. TBUT, MGS, and corneal staining scores were evaluated at baseline, 2 weeks, and 8 weeks. Symptoms were evaluated using the OSDI questionnaire at baseline, 2 weeks, and 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* history of self-reported dry eye symptoms for 3 months prior to study enrollment
* baseline OSDI score of 23 or greater (
* MGS score of 12 ior less in the lower eyelid of each eye
* TBUT \<10 seconds
* willing and able to abstain from using any new ocular lubricants

Exclusion Criteria:

* diagnosis of thyroid dysfunction or rheumatoid arthritis
* history of laser-assisted in situ keratomileusis (LASIK); any other ocular surgery within the previous 12 months
* abnormal lid anatomy or active lid lesions
* use of topical glaucoma medications, medications affecting the central nervous system, or hormonal drugs within the previous month
* active ocular infection
* pterygium
* planned use of contact lenses, topical antibiotics, steroids, or immunomodulating drops
* CDVA worse than 0.2 logMAR