cyrilzakka/clinical-trials huggingface dataset:
Hyperbaric Oxygen Therapy Registry

The purpose of the Hyperbaric Oxygen Therapy Registry (HBOTR) is to provide real world patient outcome and side effect information from electronic health records submitted to a specialty specific hyperbaric registry as part of "Stage 2 of Meaningful Use," including data provided to meet PQRS requirements via the registry's QCDR mission.

Goals include understanding the value of HBOT among patients treated for a variety of conditions in relation to the frequency and severity of HBOT side effects. While randomized, controlled trials can establish the efficacy of treatments like HBOT, because they routinely exclude patients with co-morbid conditions common to those patients seen in usual clinical practice, the results of RCTs are usually non-generalizable. Real world data can be used to better understand the effectiveness of HBOT among typical patients, as well as the risks associated with treatment.

The goal of the Hyperbaric Oxygen Therapy Registry (HBOTR) for Wounds is to provide comparative effectiveness data for patients and to understand whether clinical practice guidelines are followed in the use of HBOT.

Hyperbaric Oxygen Therapy (HBOT) is the use of oxygen at greater than one atmosphere (sea level) pressures and is administered by placing the entire patient in a pressurized vessel and having the patient breathe 100% oxygen. The minimum treatment pressure with evidence to support its use among the conditions approved by the Undersea and Hyperbaric Medical society is 2.0 atmospheres absolute (2 ATA) which is an inspired partial pressure of oxygen of approximately 1,520 mmHg. Hyperbaric treatments which provide less than 100% inspired oxygen at the treatment pressure and/or which provide an inspired partial pressure of oxygen less than 760 mmHg are not hyperbaric therapy. Topically applied oxygen is not hyperbaric oxygen therapy. Oxygen is a drug with a well-defined dose response curve as well as acute and chronic drug effects. HBOT also has side effects including oxygen toxicity to many organ systems. The physiological effects of hyperbaric oxygen therapy are well studied. Effectiveness in real world patients is the best current option to understand the role of HBOT in wound healing.

Hospital based outpatient wound centers participating in the US Wound Registry agree to provide data as part of quality initiatives and to meet their Stage 2 Meaningful use criteria. The HBOTR is a subset of the USWR (Chronic Disease Registry) data. All patient data from all participating hyperbaric centers are transmitted to the USWR where data are then used as designated for benchmarking, to satisfy the requirements of PQRS for advanced practitioners, and for data needed by the UHMS to respond to governmental agencies. Data used for effectiveness research are HIPAA de-identified.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving Hyperbaric Oxygen Therapy for any UHMS Approved indication

Exclusion Criteria:

* None
LINE: Treatment Patterns in postmenopausaL Women With Hormone Receptor Positive Breast Cancer

This is the first study focused on features/stereotypes of the first and second-line treatment patterns in Russia, comparison of different treatments, and determination of effective hormone treatment patterns in real-life practice with evaluation of pharmacoeconomic aspects. Study LINE is designed for collection of data on clinical effectiveness of second-line hormone treatment and quality of life in patients with breast cancer(BC).

LINE: Treatment patterns in postmenopausaL women wIth hormone receptor positive breast caNcEr

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women with hormone receptor-positive breast cancer:
* Recurrence after the adjuvant hormone therapy;
* Or initially inoperable locally advanced or metastatic breast cancer progressed after the first line hormone therapy;
* Ability to read and write and complete questionnaires Provision of written informed consent
* Patients who have already been prescribed therapy with the above-mentioned lines and who can continue on the prescribed therapy in the investigator's opinion according to his/her regular clinical practice and cure

Exclusion Criteria:

* As per study design, to ensure high validity of data and to obtain accurate information on real-life practice,
* Patients currently participating in other clinical studies will not be included in this study
Comparative Efficacy and Safety of Extensive Electro-Anatomical Guided Pulsed Field Ablation Versus Radiofrequency Ablation in Persistent Atrial Fibrillation

This multicenter, randomized controlled trial aims to compare the efficacy and safety of extensive electro-anatomical guided pulsed field ablation (EXT-PFA) with traditional radiofrequency ablation (RF) in treating persistent atrial fibrillation (PeAF). The trial seeks to determine if EXT-PFA, which integrates anatomical and electrogram-guided strategies, can provide superior outcomes in terms of safety and effectiveness compared to the standard RF ablation approach.


Eligibility Criteria:
Inclusion Criteria:

1.Adults aged 18-80 years diagnosed with persistent atrial fibrillation. 2.Ineffectiveness or intolerance to at least one Class I or III anti-arrhythmic drug.

Exclusion Criteria:

1. Major valvular diseases needing surgical intervention.
2. Presence of a left atrial thrombus on recent imaging.
3. Recent myocardial infarction or severe heart failure (LVEF ≤ 30%).
4. Current Severe Infection.
Protein Hydrolyzation and Glycemic Control

The insulinotropic effects of protein hydrolysate/amino acid ingestion have been shown to regulate blood glucose homeostasis in both type 2 diabetes patients and normoglycemic controls. The objective of the study is to investigate the optimal dose of such an insulinotropic mixture.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Age between 40 and 70 years
* Oral blood glucose lowering medication
* BMI \< 35 kg/m2

Exclusion Criteria:

* Exogenous insulin use
* Cardiac disease (any cardiac event in the last 5 years)
* Diabetic complications (microvascular complications, microalbuminuria: albumin:creatinine ratio \>2,5)
Anaesthetic Management Guided by COMET Measurements

Surgical site infection (SSI) is a significant cause of morbidity and mortality, prolonged hospital stays and healthcare costs. Perioperative low tissue oxygen tension is associated with a high risk of SSI. Standard anaesthetic management guided by continuous monitoring of oxygen delivery with a non-invasive method of measuring mitochondrial oxygenation tension (mitoPO2) using the Cellular Oxygen METabolism (COMET) monitor may benefit the intraoperative oxygenation on the tissue level. This randomised, controlled, single-centre, parallel-arm, patient-blinded trial aims to investigate if standard anaesthetic management guided by mitoPO2 monitoring results in higher tissue oxygen tension including patients undergoing elective abdominal surgery. Anaesthetists in the intervention group strive to a minimum mitoPO2 of 66 mmHg. Patients in the control group receive standard care. The primary outcome is the difference in means of the mean mitoPO2 during surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients are at least 18 years old
* Patients undergo elective open or laparoscopic abdominal surgery with an expected minimal total incision size of 5 cm
* Patients are able and willing to give written informed consent

Exclusion Criteria:

* Known photodermatoses of varying pathology and frequency
* Mitochondrial disease
* Porphyria
* Skin lesions on the upper arm which impede measurements
* Hypersensitivity to the active substance or the 5-ALA medicated plaster material
* Emergency surgery
* Reoperation for complications from recent surgery (within last three months)
* Participation in another study with interference with this study
* Pregnancy or breastfeeding
Six Months DHEA Treatment in Female Adrenal Failure

DHEA is an adrenal deriven androgen precourser. The impact of DHEA substitution therapy in adrenal failure is unknown as well as the physiologically effects of DHEA is unknown. Effects of physiologically DHEA substitution is investigated in the model of female adrenal failure.


Eligibility Criteria:
Inclusion Criteria:

* Female,
* Adrenal insuficiency,
* Stable and safe anticonception,
* Stable hydrocortison substituation treatment.

Exclusion Criteria:

* Neoplastic and thromboembolic disease,
* Diabetes mellitus.
Advanced Endoscopic Imaging in Colonoscopy

The aim of the study is to evaluate the usefulness of high-tech endoscopy in clinical practice.

The important elements of this evaluation are:

* Evaluation of the character of neoplastic lesions in the colon based on different imaging techniques
* Verification of the endoscopic image with histopathologic descriptions
* Establishing the type of the lesion on the basis of Kudo and NICE classifications
* Comparison of the result of histopathological examination with the macroscopic type of the lesion
* Determination of the most advanced lesions (MAL)
* Comparison of the cecal intubation time
* Evaluation of the type of anesthesia used during colonoscopy
* Subjective assessment of the severity of pain according to VAS (visual analogue scale)
* Comparison of the accuracy of the location of lesions on the basis of endoscopic navigation
* Comparison of the total examination time
* Comparison of adenoma detection rate

A total of 400 consecutive patients undergoing unsedated colonoscopy as a part of a national colorectal cancer screening program will be randomly assigned to innovative or conventional examination. Randomization will be based on computer-generated randomization lists. All patients will be blinded so they will not know which techniques will be used to assess lesions found in colon. In innovative colonoscopy group narrow band imaging (NBI) and Dual Focus (DF) function will be used to identify and classify all lesions according. to Kudo and NICE classification. Endoscopic biopsy samples will be taken from all lesions and in vivo endoscopic diagnosis will be compared with final histopathological result. Thus, sensitivity, specificity, diagnostic accuracy, predictive values, likelihood ratio and Youden index will be calculated. As secondary endpoints total examination time, cecal intubation rate and pain intensity (VAS) will be determined. This study will help to establish whether advanced imaging technologies used during colonoscopy may improve diagnostic possibilities and whether they prolong examination time or lead to increase of pain intensity afterwards.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* no previous abdominal surgery
* no colonoscopy during last 10 years

Exclusion Criteria:

* age \< 40 and \> 65 years
* large bowel resection in history
* colonoscopy performed during last 10 years
* contraindications for general anaesthesia
* ASA \> IV
* pregnancy
* confirmed neoplastic disease
* cirrhosis (Child B or C) or ascites
* immunosuppressive therapy or steroids intake
* malabsorption syndrome
* IBD
* GI neoplastic disease
Investigation of Muscle Oxygenation in Patients With Rheumatoid Arthritis

The aim of this study is to investigate respiratory muscle strength, respiratory muscle endurance, muscle oxygenation, upper extremity and lower extremity exercise capacity in rheumatoid arthritis patients compared with healthy individuals.

Rheumatoid arthritis (RA) is a chronic progressive autoimmune disease of unknown etiology with symmetric erosive synovitis and multisystem involvement. The disease causes significant long-term morbidity, reduced functional capacity, and increased mortality rates. Patients with rheumatoid arthritis avoid physical activity due to pain and fatigue. Despite the advances in pharmacological treatments in recent years, functional losses due to rheumatic diseases the resulting deterioration in quality of life, and loss of work continue. Physical inactivity is known to have detrimental effects on the cardiovascular and pulmonary systems by reducing muscle strength and aerobic capacity. The physiological reasons underlying skeletal muscle oxygenation that may cause muscle dysfunction in rheumatoid arthritis have not been investigated. In these patients, decreased arterial oxygen may reduce exercise capacity and cause muscle deoxygenation.

In rheumatoid arthritis patients, decreases in respiratory muscle strength, lung volumes, oxygen consumption, and six minute walk test distance cause cardiopulmonary deconditioning. Decreased exercise capacity increases the risk of cardiovascular disease and causes mortality in patients with RA.

This study aimed to, the effects of respiratory muscle strength, respiratory muscle endurance, upper and lower extremity muscle oxygenation, and upper and lower extremity exercise capacity in patients with stable disease activity.

Eligibility Criteria:
Rheumatoid Arthritis Group

Inclusion Criteria:

* Patients diagnosed with rheumatoid arthritis,
* The ages of 18-65 years,
* Volunteer to participate in the study will be included in the study.

Exclusion Criteria:

* Serious cardiopulmonary, neurological, neuromuscular, orthopedic and other systemic diseases or other diseases affecting physical functions,
* Participated in a planned exercise program in the last three months,
* Cognitive impairment that will cause difficulty in understanding and following exercise test instructions,
* Contraindications to exercise testing or exercise training according to the American Sports Medicine Association will not be included in the study.

Control Group

Inclusion Criteria:

* The ages of 18-65 years,
* Volunteer to participate in the study will be included in the study.

Exclusion Criteria:

* Diagnosed chronic or systemic disease,
* Regular exercise (physical activity) 3 days a week, 150 minutes/week of moderate intensity
* Smoking 10 packs x years or more,
* Pneumonia or any acute infection,
* Healthy individuals with any psychiatric disorder will not be included in the study.
Peritonitis and Loss of Residual Renal Function, Technique Failure and Mortality in Peritoneal Dialysis Patients

The primary objective is to analyze peritonitis rate and peritonitis bacteriology as risk factors for loss of residual renal function, technique failure and mortality in chronic kidney disease patients.

Secondary objectives are: To know the current rate of peritonitis in peritoneal dialysis population and to understand the bacteriological profile of peritonitis.

To know the rate and risk factors other than peritonitis involved in the loss of residual renal function.

To analyze the utility of alternative diagnostic tests, such as reagent strips, for early detection of peritonitis when traditional tests are not available.

To analyze the simultaneous measurement of serum creatinine and cystatin-C as alternative measurements of peritoneal clearance and residual renal function.


Eligibility Criteria:
Inclusion Criteria:Inclusion criteria include: adult patients with signed informed consent given; there should not be selection for age, gender, primary cause of renal disease.

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Exclusion Criteria:Patients will not be included if they were previously in hemodialysis or received renal transplant. Patients will also be excluded if they are on immunosuppressive therapy, have diagnosis of cancer, or are seropositive for HIV or hepatitis.

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Four-limb Blood Pressures in Infants With High Risk of Congenital Malformation of Aorta

Pulse oximetry screening (POS) for critical congenital heart diseases (CCHD) could identify 90% of these infants. However, this approach is not designed to detect cardiac defects without hypoxemia, especially congenital malformations of aorta (CMoA). More than 60% of CMoA was late diagnosed.

Infants with CMoA were supposed to present with blood pressure (BP) gradient between four limbs. But a large sample size retrospective study of four-limb BP screening showed a negative result. The possible reason is that this study ran in population with a very low risk of CMoA. Whether four-limb BPs measurement could be used in infants with high risk of congenital malformation of aorta is still to be determined.

The investigators retrospectively collected four-limb BPs, which was prospectively measured, in infants with high risk of CMoA. These data were divided into two groups, the discovery group and the validation group. The best cutoff of four-limb BP gradient was generated by Youden Index. The BP gradients by age were analyzed. Pre-operative hypotension and post-operative hypertension were also analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Infants admitted to the Guangdong Provincial People's Hospital between January 1st, 2013 and December 31st, 2019, who were suspected as having congenital heart disease, were enrolled in the study.

Exclusion Criteria:

* Infants without four-limb blood pressures measurement or without echocardiogram and cardiac computed tomography results were excluded.
Global CALM Implementation Study

This study seeks to evaluate the implementation of the Managing Cancer and Living Meaningfully (CALM) Program in diverse cultural settings, including its feasibility, fidelity, and acceptability. It will also assess the cross-cultural generalizability of the CALM intervention with a particular focus on patient-reported outcomes with regard to psychological well-being and quality of life.

CALM is a semi-structured, manualized, individual psychotherapy designed for patients with advanced cancer and their loved ones. Research conducted over the past decade has shown that CALM is a feasible, acceptable, and effective therapy for patients with advanced or metastatic cancer.

The CALM Training Program was developed to train oncology clinicians in the delivery of CALM. The training program consists of: 1) introductory workshops, which provide foundational training in the intervention; 2) advanced workshops, which support the development of advanced therapeutic skills; and 3) ongoing case supervision, delivered in small-group format, either in-person or online, which provides an opportunity for continuing improvement and refinement in the delivery of CALM.

To evaluate the implementation of the CALM Program at the clinician and organization levels, we will approach clinicians engaging in the CALM Training Program and invite them to participate in this research study, which includes completion of quantitative measures at baseline, 1 year (primary endpoint) and 2 years (study endpoint), participation in qualitative interviews, and collection of feasibility data. Implementation science frameworks will be applied to assess participants' perceived individual- and contextual-level barriers and facilitators to implementing CALM through qualitative interviews.

Sites involved in the Global CALM Program will conduct pilot studies of CALM in their setting to evaluate CALM at the patient- and caregiver-levels. We will not be involved in the collection of prospective patient- and caregiver-level data, however data will be pooled and analyzed to assess the cross-cultural generalizability of the CALM intervention.

Eligibility Criteria:
Inclusion Criteria:

The research team will approach clinicians who:

* have expressed interest in taking part in the Global CALM Program;
* able to deliver psychotherapeutic care according to the legislation/organizational policy that regulates their profession;
* ≥18 years of age;
* able to provide informed consent;
* fluent in English (or other language(s) in which training and supervision will be offered);
* fluent in the main language spoken in the country where their centre is located (to be able to deliver CALM sessions); and
* willing/able to engage with training in the CALM therapy and attend in-person or online supervision meetings (based on feasibility).

Exclusion Criteria:

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Facial Skin Health Tracking Feasibility in Breast Cancer Patients

This feasibility study will assess if tracking objective and subjective facial skin changes over time is acceptable to pre and perimenopausal women undergoing chemotherapy and/or endocrine therapy for breast cancer. There is no intervention arm and no control group. Skin health will be assessed through the instruments described below, and subjective data will be collected with self-administered questionnaires.

There are no studies objectively assessing changes to facial skin health in this population, but tools exist to objectively measure changes thus we have chosen to use those tools to measure skin health. Before embarking on an intervention study showing improvement in skin health and patients' self-image and QOL, we first need to see if 1) it is feasible to measure changes in skin health in this population and 2) if skin health does objectively change over the course of therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Provision to sign and date the consent form
2. Stated willingness to comply with all study procedures and be available for the duration of the study
3. Be a pre or perimenopausal woman age 18 or over
4. Be a patient with a new diagnosis of breast cancer who plans to undergo systemic chemotherapy or endocrine therapy, but who has not yet started treatment

Exclusion Criteria:

1. Postmenopausal status (one year without a menstrual period)
2. Pregnant women (pregnancy test not required)
3. Prior cancer diagnosis of any type other than breast cancer
4. History of prior treatment with chemotherapy or radiation therapy
5. Chronic skin disease including scleroderma, discoid lupus, atopic dermatitis, rosacea, eczema, or psoriasis
6. Use of a retinoid-based prescription facial skin product within the past 11 month
Persistent Pain Among Elderly Experiencing Motor Vehicle Collision

Chronic problems after traumatic events are common in non-elderly adults. Previous studies have shown that after minor motor vehicle collision (MVC), 10-30% of non-elderly adult patients develop chronic regional pain (neck or back pain). In addition, up to 1/3 of non-elderly adults will develop psychological sequelae, including posttraumatic stress disorder, depression, and anxiety disorders. There have been no prospective studies examining the frequency or predictors of persistent pain or psychological sequelae in older adults. The proposed study seeks to determine the frequency of persistent pain, psychological sequelae, and associated disability in older adults after minor MVC trauma and to identify candidate predictors for a model of adverse outcomes after MVC in this population. 200 individuals over 65 years of age will be recruited from emergency departments in four states with no-fault accident laws. Patients who meet inclusion criteria and who consent to the emergency department (ED) study will undergo a 30-45 minute ED assessment of crash-related, psychosocial, and biological factors, and complete telephone follow-ups at 2 weeks, 6 weeks 6 months, and 12 months. The wealth of information gained from this study will be used to determine the frequency of adverse events in older adults after MVC and to identify high risk elderly patients. These results will inform subsequent development of secondary pharmacologic and/or behavioral interventions to prevent chronic pain and psychological sequelae after traumatic events in older adults.


Eligibility Criteria:
Inclusion Criteria:

* Patient speaks English, presented to ER less than 24 hours after an MVC, patient has an address and telephone

Exclusion Criteria:

* Patient
* is a prisoner,
* has fractures or an intracranial injury,
* has injuries that are life threatening or expected to result in hospitalization for more than 72 hours,
* is receiving end of life, hospice, or comfort care, or
* is considered ineligible by treating physician.