cyrilzakka/clinical-trials huggingface dataset:
From ACute To Chronic Postoperative Pain in Patients for Elective Cholecystectomy

Chronic Pain is a wellknown complication after cholecystectomy. Intensity of the pain in the first week after the operation is a predictive factor for the development of chronic pain, but it is unknown whether the risk is more related to one of the different components of acute pain (ie somatic, visceral, referred). Furthermore the chronic pain has not been systematically described in terms of type of pain or sensory abnormalities etc. (allodynia, hyperalgesia etc.).

The purpose of the study is to examine whether intensity of components of acute pain is predictive for development of chronic pain after cholecystectomy and to characterize the chronic pain by quantitative sensory testing.

DNA-samples are collected to examine genetical factors, important for perception of pain, and the development of chronic pain.


Eligibility Criteria:
Inclusion Criteria:

* Patients for elective cholecystectomy
* 18 years or older at the day of the operation
* Capable of speaking, reading and writing danish

Exclusion Criteria:

* Previous abdominal operation
* Patients with preoperative neuropathies
* Patients with other diseases in the nervous system, preoperative paresthesias or other sensory disturbances.
Motor Outcomes to Validate Evaluations in Pediatric FSHD (MOVE Peds)

The primary goal of this study is to validate motor and functional outcomes and refine clinical trial strategies for pediatric-onset FSHD

MOVE Peds is a prospective 2-year study recruiting eighty pediatric participants to accelerate therapeutic development for pediatric-onset FSHD. The study aims to validate outcomes and refine clinical trial strategies. Previous cross-sectional studies suggest that younger age of onset is linked to greater clinical severity and that having 1-3 D4Z4 repeats is associated with extra-muscular complications in pediatric FSHD.

Prospective studies in early-onset FSHD have been limited by the small number of sites and low recruitment and follow-up rates. Early-onset pediatric FSHD is of high interest to drug companies because:

1. It results in a more significant disease burden than in adults.
2. Treating FSHD at earlier ages may have a more lasting and profound effect.
3. Genetic, molecular, and clinical factors may differ between pediatric and adult-onset FSHD.
4. Smaller body size and faster progression rates may make AAV-delivered gene therapies more feasible.

The FSHD CTRN's previous research showed that the FSHD composite functional measure (FSHD-COM), reachable workspace (RWS), and quantitative MRI measures (qMRI) are responsive to disease progression or treatment in adults with FSHD and correlate with performance. Investigators hypothesize that early changes in qMRI in pediatric subjects will predict 2-year changes in FSHD-COM Peds or RWS.

Eligibility Criteria:
Inclusion Criteria:

* Age 5-17 years.
* Genetically confirmed FSHD (types 1 or 2).
* Symptomatic weakness (facial, shoulder, core, or limb weakness)
* Able to complete a 10-meter walk without the support of another person in less than 12 seconds (canes, walking sticks, and braces allowed; no walker). In order to include early onset participants up to 8 individuals will be entered with baseline 10MWR \> 12 seconds or who are no longer ambulatory (≤10%)

Exclusion Criteria:

* Unwilling or unable to provide informed consent or assent. Any other medical condition which in the opinion of the investigator would interfere with study participation.
* Malignancy with ongoing treatment with chemotherapeutic agents or anabolic agents
* Use of immunosuppressants including prednisone or performance enhancing drugs including testosterone within 6 months
* Pregnancy
* Recent or ongoing infection
* Presence of contraindication to performance of MRI: pacemaker, metallic foreign body in eye, brain aneurysm clip (unless documented as MRI compatible)
* In the opinion of the investigator unable to follow directions for standardized testing

  * Note: Not being able to complete MRI will not result in a screen failure. If subject is not able to complete the procedure due to fear or anxiety, they will have the opportunity to try again at later visits. However, Subject must be willing to attempt to perform the MRI to meet inclusion/exclusion criteria
Human Papilloma Virus (HPV) Self-collection and Women Adherence

Despite declining mortality in high-income countries, cervical cancer continues to be a public health problem in low and middle -income countries. HPV tests have shown a better sensibility and a higher capacity of reducing mortality than cytology based-screening. Greater participation has been demonstrated with the use of HPV self-testing when it is offered to women with a poor screening history; however, it is not clear whether getting tested necessarily translates into a greater adherence to the entire clinical protocol, including diagnosis and treatment of precancerous lesions. The aim of this study is to evaluate the effect of the self-testing techniques on the participation and adherence of women to cervical cancer screening.

The investigators will perform a randomized clinical trial with three arms including: regular HPV with cytology triage, colpo/biopsy, and treatment if indicated; HPV self-collection without cytology triage but with colpo/biopsy and treatment if indicated, HPV self-collection with immediate treatment for women with positive test results. This study will be carried out in two different settings with differential access to diagnosis and treatment. Two methods will be used for inviting women and collecting samples: mail and door-to-door. Participation (screening uptake) and adherence to the clinical protocol (compliance with diagnosis and treatment) will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Women 30-65 years old
* No history of cytology or any other screening test for cancer of the cervix in the past 5 years
* Be linked to one of the health providing entities participating in the study
* Women who sign the informed consent.

Exclusion Criteria:

* Women 30-65 years old
* No history of cytology or any other screening test for cancer of the cervix in the past 5 years
* Be linked to one of the health providing entities participating in the study
* Women who sign the informed consent.
Drug Elution and Distal Protection During Percutaneous Coronary Intervention in ST Elevation Myocardial Infarction

The purpose of this study is to evaluate the clinical, echocardiographic and angiographic outcome of distal protection in the infarct related coronary artery and implantation of drug eluting versus bare metal stents in patients with ST-elevation myocardial infarctions treated acutely with percutaneous coronary intervention.


Eligibility Criteria:
Inclusion Criteria:

* Acute onset typical chest pain of \< 12 hours' duration
* ST-elevation of \> 4 mm (1mm = 0.1 mV) in contiguous leads of the electrocardiogram
* High grade stenosis or occlusion of a native major coronary artery that can be crossed with a soft or intermediate tip guidewire
* Possibility to perform distal protection of the infarct-related artery

Exclusion Criteria:

* History of previous myocardial infarction
* Use of fibrinolytic agents for the index infarction
* Left main stenosis
* Heavily calcification of abdominal aorta or occlusive iliofemoral disease hampering access to the coronary ostias by the femoral route
* Known renal failure
* Other significant cardiac disease
* Other severe disease with an expected survival \< 1 year
* Known allergy against clopidogrel or contrast media that can not be avoided/limited by medication
* Linguistic difficulties needing an interpreter
* Gastrointestinal bleeding within 1 month
* Childbearing potential or pregnancy
* Participation in another study
Research on the Application of Electrical Impedance Tomography in Bronchial Challenge Testing

The purpose of this study was to examine whether electrical impedance tomography (EIT) was capable of identifying the deteriorated lung function on a regional level during bronchial challenge testing and whether EIT may provide additional information during bronchial challenge testing and identify spatial and temporal heterogeneity of regional lung function.

The content of this study includes:

1. Can EIT identify the uneven ventilation caused by airway contraction in patients during bronchial provocation tests.
2. Can EIT monitor airway contraction in patients before Spirometer examination after inhaling activators.
3. Can EIT observe uneven ventilation caused by airway contraction through tidal breathing after the patient inhales activator.

Eligibility Criteria:
Inclusion Criteria：

1. Patients suspected of asthma who require bronchial challenge testing.
2. The Bronchodilator responsiveness testing is negative.
3. patients with a pre-bronchodilator FEV1 \>60% predicted.
4. No contraindications for bronchial provocation test examination.
5. Fully understand the purpose and significance of this study, and voluntarily participate in the research.

Exclusion Criteria:

1. patients with a pre-bronchodilator FEV1≤60% predicted.

1. Contraindications for bronchial challenge testing.
2. Pregnant or lactating women.
3. After pacemaker surgery.
Asthma Symptom Perception Study

Asthma affects 8% of the United States population ages \>60 years and causes considerable harm: older adults are 4 times more likely to die from asthma and have twice the risk of hospitalization. The burden of asthma is notably greater among minoritized older adults. Research suggests that perception of expiratory airflow limitation may be a major determinant of asthma outcomes in older adults, and that older adults are substantially less aware of airway obstruction than younger adults. These observations suggest that perception of airflow limitation is a potential target for improving outcomes of older patients with asthma. The research team completed a pilot randomized controlled trial (RCT) of an intervention that trains older adults with asthma to better perceive expiratory airway obstruction through feedback via peak expiratory flow (PEF) prediction and couples this feedback with motivational interviewing (MI) to promote change in asthma self-management behaviors. Compared to an attention control, the intervention improved PEF, perception of airflow limitation and asthma control. In this project, the research team will conduct a fully powered RCT to test the intervention's efficacy among 300 adults ages ≥60 years with uncontrolled asthma who are on controller medications (daily maintenance or as needed) recruited from underserved inner-city medical practices in New York City. Patients will be randomized to the intervention or a time and attention matched educational control. The intervention and control will be delivered in 3 sessions over 6 weeks. The study will test the impact of the intervention on perception of expiratory airflow limitation in older adults with asthma, examine the efficacy of the intervention for improvements in lung function (PEF), self-reported asthma control (Asthma Control Questionnaire \[ACQ\] scores), quality of life (Asthma Quality of Life Questionnaire \[AQLQ\] scores), and emergency department and hospital use, and test the intervention's impact on mean daily ICS dose used (daily maintenance and as needed). Data will be collected at baseline, 1-month, 6-months (primary analyses of effectiveness) and 12-months post-intervention. In secondary analyses, the research team will test the sustainability of treatment effects with vs. without the booster treatment session (active booster vs. attention control booster) delivered immediately after the 6-month assessment on outcomes at 12-months.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 60 years
* English or Spanish speaking
* Self-report or physician diagnosis of asthma \>1 year ago
* Uncontrolled asthma

Exclusion Criteria:

* Dementia
* Chronic obstructive pulmonary disease (COPD), or other chronic respiratory illnesses,
* Congestive Heart Failure (CHF, New York Heart Association \[NYHA\] stages 4-5)
* Cigarette smoking \>15 packs-years
Needs Assessment of Knowledge, Beliefs, and Attitudes of Patients With Hemophilia B About Gene Therapy

Gene therapy is a paradigm-shifting treatment for hemophilia B patients, particularly in resource-limited countries where factor availability remains low. Transparent and culturally sensitive communication around gene therapy is vital to the success of a high-quality consenting process. Current literature on knowledge, beliefs and attitudes about gene therapy in resource-limited countries is inadequate. In addition, few educational resources to explain basic gene therapy concepts exist in languages other than English. This study aims to address these gaps in knowledge and aid for the development of educational resources to assist the informed consent processes for gene therapy in resource-limited countries.

Primary Objective:

To assess baseline knowledge, beliefs, and attitudes about gene therapy held by hemophilia B patients globally

Secondary Objectives:

1. To explore healthcare workers' (i.e., physicians, nurses, social workers, educators/academic coordinators) perspectives regarding the education needs of hemophilia B patients globally
2. To explore healthcare workers beliefs and attitudes about gene therapy
3. To identify preferences of patients with hemophilia B and their healthcare workers on how/by what method or pathway educational content should be provided.

This prospective cohort study will use qualitative methods, specifically semi structured interviews to evaluate knowledge, beliefs, and attitude about gene therapy in patients 12 years and older with a diagnosis of moderate and severe hemophilia B (≤2% FIX activity only), caregivers/parents and healthcare workers who care for them at St. Jude and other global countries. Participants will be interviewed virtually using an online video-conferencing platform, phone or in person.

Interviews will be performed by experienced qualitative interviewers in the official language of each participating site. Interviews will last approximately 45-60 minutes and will be performed only once. All interviews will be audio recorded and obtained information will be analyzed using semantic content analysis to identify common themes.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥12 years of age
* Diagnosis of moderate (FIX ≥1% and ≤2%) or severe (\<1%) hemophilia B
* Parents or caregivers to patients with hemophilia 12-17 years of age

Inclusion Criteria - Healthcare worker:

- Doctors, nurses, social workers, pharmacists and educators who participate in the care of hemophilia B patients

Exclusion Criteria:

* Diagnosis of Hemophilia A
* Diagnosis of other non-Hemophilia B bleeding disorders

Exclusion Criteria - Healthcare worker:

* Health care workers who do not participate in the care of hemophilia B patients
* Healthcare worker who is conducting the interviews
Emergency Department Targeted Ultrasound for the Detection of Hydronephrosis

An Emergency Department Targeted Ultrasound (EDTU) is an ultrasound examination performed by an emergency department physician, instead of a radiologist or ultrasound technician. EDTU is intended to be a readily assessable test performed at the bedside, to quickly and safely determine the presence of a disease state; it answers a binary question, as compared to formal ultrasound imaging which seeks to determine the cause of a patient's symptoms.

The objective of this study is to determine the accuracy of EDTU in patients suspected of renal colic. By demonstrating excellent test characteristics, these investigators hope that this research will be used to incorporate EDTU for hydronephrosis into standard emergency care in Canada.


Eligibility Criteria:
Inclusion Criteria:

* Emergency Department patients
* Males and Females
* Age 16-65
* Undergoing CT scan of the abdomen or formal ultrasound of the abdomen at Kingston General Hospital or Hotel Dieu Hospital in Kingston, Ontario.

Exclusion Criteria:

* Hemodynamic instability
* Fever
* Leukocytes or nitrites on dipstick urinalysis
* Pregnancy
* Renal failure
* Single functioning kidney or renal transplant
The Effect of Yoga Exercises and Callisthenic Exercises on the Quality of Life in Healthy Individuals

In this study, healthy individuals will be asked to do yoga exercises or a calisthenic exercise program. The effect of different exercise programs on quality of life will be investigated.

While yoga was a part of the philosophy of life in India, today it has become widespread as a physical and mental practice and has become a preferred approach to protect and improve physical functions, especially in healthy individuals. The word yoga means "union" and "unity". It is a group of practices or disciplines that mainly include physical movements , special breathing techniques and deep concentration. A study on this subject has shown that Yoga training applied to healthy individuals increases muscle strength, muscle endurance and flexibility, and reduces stress levels.

Calisthenic exercises; These are exercises that are performed by creating resistance only with your body weight, without the need for any equipment or gym. Calisthenic exercises are aerobic and dynamic exercises. Calisthenics exercises are a useful and useful exercise method that can be done at a fast pace, at different intensities, and can also be modified. Calisthenic exercises should be rhythmic and performed by counting. A study on this subject has shown that calisthenic exercises improve muscle strength and balance.

In this study, healthy individuals will be asked to do yoga exercises or a calisthenic exercise program. The effect of different exercise programs on quality of life will be investigated.

Eligibility Criteria:
Inclusion Criteria:

1. The ages of 18 - 45
2. No communication problems
3. Not having had a surgical operation in the last 6 months

Exclusion Criteria:

1. Individuals with musculoskeletal system problems that prevent them from exercising
2. Individuals who have respiratory problems when their physical activity increases
3. Individuals with a history of chest pain related and unrelated to physical activity
4. Individuals with chronic diseases
D-Light Intervention

Vitamin D insufficiency has become a global concern, with low vitamin D status associated with bone disorders, cardiovascular disease and certain cancers. The United Kingdom (UK) and Ireland are at particular risk of vitamin D deficiency owing to the northerly latitude, increased use of sunscreen, decreased sun exposure and a high level of cloud cover. A recent survey in the UK showed that more than 50% of UK adults have insufficient vitamin D status, with lower levels noted in the winter months. Variations in vitamin D status have been known to vary between summer and winter, owing to our northern latitude (52-55°N) the Ultraviolet (UV)-B intensity in Northern Ireland is inadequate to promote the dermal synthesis of vitamin D during the winter months, causing us to rely on dietary sources. The aim of this intervention is to investigate the main effects of vitamin D3-fortified milk and supplemental vitamin D3 on vitamin D status and functional health outcomes during the winter, and how this intervention will affect subsequent dermal synthesis of vitamin D from UV exposure. Participants will be recruited from the local community. Blood samples will be collected from each participant at two timepoints (September/October and March/April). Pre- and post-intervention blood pressure, grip strength, height, weight, waist and hip circumferences will be measured, in addition participants will undergo a dual energy x-ray absorptiometry (DXA) scan to assess body composition and bone mineral density. Information on general health, lifestyle, physical activity, dietary intake and typical behaviours in the sun will be collected. Following the dietary intervention, a subset of participants will be invited to participate in a follow-up study, examining UV exposure during the summer months, when they will wear a personal wrist dosimeter for 1 month, complete a sun dairy and provide 2 additional blood samples.


Eligibility Criteria:
Inclusion Criteria:

* 20-40 years old
* Apparently healthy
* Living on the island of Ireland

Exclusion Criteria:

* Below 20 years and aged 40 years or above
* Not living on the island of Ireland
* Pregnant or lactating women and those planning to become pregnant
* Individuals who have been taking a vitamin D or calcium containing supplement in the previous three months
* Those with food intolerances or allergies that would affect their ability to consume study milk
* Individuals following a diet which excludes milk (e.g. vegans)
* Those with a diagnosed chronic medical condition or on prescribed medication known to effect vitamin D metabolism
* Those who are planning a sun holiday during the winter months (Oct-Mar)
* Adults with learning, or any other difficulties that would prevent them from completing the study protocol
Perioperative Insulin Glargine Dosing Study

The main objective of this study is to compare three strategies of evening insulin glargine dosing to preoperative glucose values in patients with diabetes undergoing surgery to determine which dosing strategies most often achieves the admission target study values of 100-179 mg/dl.

There are no evidence-based guidelines for insulin glargine (Lantus) dosing in the perioperative setting. Insulin glargine provides peakless 24-hour coverage of basal insulin needs for people with both Type 1 and Type 2 diabetes. Insulin glargine may be used as the sole insulin or in combination with other rapid-acting insulin to achieve glycemic control.

Anesthesia literature recommends that blood sugar values on insulin-dependent patients be maintained between 120-180 mg/dl in most surgeries. Symptoms of low blood sugar are undetectable in anesthetized patients, and blood glucose is tested at least hourly. Since patients are still awake and alert toward hypoglycemic symptoms in the preoperative area, the admission target study values are 100-179 mg/dl. Glucose values greater than 200 mg/dl have been associated with increased rates of infection, and exacerbated complications if a major cardiovascular event happens.

Frequently insulin glargine is administered in the evening. Patients who are scheduled for surgery in the morning are asked not to eat or drink after midnight. Some endocrinology experts recommend that all or part of the patient's usual insulin glargine should be given to avoid high blood sugar; however, whenever insulin is given without food, the possibility of low blood sugar exists.

1. Patients in Group 1 will administer 80% of their usual insulin glargine dose.
2. Group 2 patients will contact their own diabetes care physician and follow those recommendations for the dose.
3. Group 3 patients will take 50%, 80%, or 100% of their usual insulin glargine dose. Which of those three percentages will be determined by the midpoint of the patient's usual self-reported fasting blood sugar (FBS) range and whether the patients is also taking a rapid-acting insulin.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for Surgical Procedure
* Self Management of Diabetes
* Currently on Evening Insulin Glargine prescribed by Primary Care Physician
* Age 18 or over
* Able to Communicate Clearly over the Phone
* Pre-screened by Anesthesia Department \> 48 hours prior to Surgery

Exclusion Criteria:

* On Glucocorticoid Medication
* On Insulin Glargine Dual Dosing or Sliding Scale Regimen
* History of Hypoglycemia Unawareness
* Pregnancy or Lactating Female
* On Insulin Glargine for \< 3 months