cyrilzakka/clinical-trials huggingface dataset:
Study Into Genetic Influence on Cholesterol Response to Dietary Fat

Cardiovascular disease (CVD) is recognised as one of the main causes of death in the western world. LDL- cholesterol ('bad' cholesterol) and other lipids (fats) are important CVD risk factors. Apolipoprotein E (apoE) is an important transporter of fats in the blood. ApoE comes in E2, E3 and E4 forms, depending on your genetic make up. Approximately 60% of the UK population are E3/E3, 25% E4 carriers and 15% E2 carriers. There is some evidence to suggest that an E4 genotype may put you at modestly higher risk of CVD. Furthermore although very inconclusive previous studies have suggested that E4 individuals are slightly more sensitive to the LDL-cholesterol modifying effects of dietary fats (saturated fat, total fat, fish oil) showing slightly, greater reductions when low levels of these fat are consumed, and greater increases when high levels of these fat are consumed. Therefore, the aims of the Satgene study is to examine the impact of modifications in dietary total fat and saturated fat intakes, alone and in combination with fish oil supplement on LDL-cholesterol and other blood lipids, in individuals with an E3 and E4 genotype. The levels of total fat and saturated fat used in the current study are within the range observed in a typical UK population.


Eligibility Criteria:
Inclusion Criteria:

Men \& women 35-70 years BMI 20-32 kg/m2 Haemoglobin (anaemia): 12.5-18.0g/l (men) and \> 11.5-16g/l (women) Gamma GT (liver function) (\< 80 IU/l), Triglyceride (between 1-4 mmol/l), Plasma total cholesterol (4.5-8 mmol/l) Glucose (World Health organisation recommend \<7 mmol/L).

Exclusion Criteria:

* Females who are breast feeding, may be pregnant, or if child-bearing potential are not taking effective contraceptive precautions
* Likely to alter oral contraceptive or HRT usage during the course of the study
* Blood Pressure \> 160/100 mm Hg (UK guidelines for stage 2 hypertension)
* Had suffered a myocardial infarction or stroke in the previous 12 months
* Hypertensive medication
* Diabetics type I and II
* Any volunteers on a weight reducing diet, or vegan/vegetarians as study requires consumption of dairy products and fish oils
* On high dose fish oil supplements (\> 1g EPA + DHA per day)
* Elevated lipids requiring medication such as statins, fibrates, gall bladder problems or other abnormalities of fat metabolism
* Subjects not willing to make the necessary dietary changes during the study
* Subjects drinking excessive alcohol (UK recommendations/wk currently for men are, no more than 21 units of alcohol per week or more than four units in any one day. For women, no more than 14 units of alcohol per week or more than three units per day).
* Subjects who train at a high level, or attend more than 3 hours organised exercise classes per week
Post-Endoscopic Infection Rate Notifications to Improve the Delivery of Care

This project will notify centers of center's post-endoscopic infection rates and evaluate the effectiveness of this notification system to decrease infection rates. The investigators aim to notify centers of the number of patients and center's risk-adjusted rates of hospitalizations for infections after colonoscopy and esophagogastroduodenoscopy (EGD) procedures performed between January 2015 and September 2018. The investigators will randomize centers to two notification groups: (1) Ability to view center's rate compared with all other centers (ASCs and outpatient centers notified and compared separately) or (2) Ability to view center's rate compared with the other centers with a similar patient comorbidity profile and in addition to viewing option 1. Facilities will answer questions about center's infection control practices. The investigators hypothesize that centers with high rates of post-procedural infections will (1) be more likely to report that the center took action to investigate the center's infection control practices after the first notification and (2) observe a decrease in infections after the notification. The investigators anticipate that centers with high rates of post-procedural infections that are randomized to group 2 will have greater change. The investigators anticipate no change in rates of infection in the facilities that had zero or very low (n=1) event rates.


Eligibility Criteria:
Inclusion Criteria:

* Facilities that bill to fee for service Medicare for gastrointestinal endoscopy

Exclusion Criteria:

-
The Impact of App-based Cognitive Training on Post-stroke Upper Extremity Rehabilitation

To find out the impact of app-based cognitive training on upper extremity function in patients with sub-acute stroke.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 45-70 years.
* Both male and female gender.
* Patients of sub-acute stroke patients with impaired upper extremity function
* Stroke patients suffering from mild to moderate cognitive impairment.
* Patients with the ability to fulfill and comprehend commands

Exclusion Criteria:

* Patients of neurodegenerative diseases like Parkinson's, multiple sclerosis etc.
* Patients suffering from any severe psychological disorder.
* Patients with severe contracture due to orthopedic disease of the shoulder, elbow, and wrist joints
Erector Spinae Plane Blocks (ESP) for Postoperative Pain in Lumbo-sacral Spine Surgery

The goal of this study is to evaluate the analgesic efficacy of bilateral erector spinae plane (ESP) blocks after lumbar and lumbo-sacral spine surgery by assessing postoperative pain scores and opiate requirements as the primary outcome measures. We are aiming to investigate how ESP blocks, performed under ultrasound guidance at the T12 vertebral level, contribute to postoperative pain control. This will be determined by measuring numerical rating pain scores repeatedly following surgery and opiate consumption until patient discharge from hospital. These primary outcome measures will be compared between a treatment group of participants, who will receive ESP blocks and a control group who will receive a sham block. Our primary hypothesis is that ESP blocks significantly reduce postoperative pain and opiate requirements


Eligibility Criteria:
Inclusion Criteria:

* Spine surgery at or below the L1 vertebral level
* Midline surgical approach

Exclusion Criteria:

* Previous lumbar or lumbo-sacral surgery with or without hardware placement
* Evidence of dura pathology (including CSF leak)
* Spine tumor
* Non-English speaking
Evaluation of Alternative Transfusion Triggers in Hemodynamically Stable, Non-Ventilated Cancer Patients: A Prospective Observational Study

This is a prospective, single-center observational study conducted at the Kazakh Institute of Oncology and Radiology. The study included 107 clinically stable adult patients with cancer who required red blood cell transfusion based on a restrictive hemoglobin threshold. The aim of the study was to evaluate alternative physiological indicators of transfusion need and effectiveness. Measurements included oxygen extraction ratio (O₂ER), central venous oxygen saturation (ScvO₂), partial pressure of oxygen in central venous blood (PvO₂), arterio-venous oxygen difference (A-VO₂diff), lactate, and veno-arterial carbon dioxide difference (ΔCO₂). These parameters were assessed before and one hour after transfusion. For data analysis, patients were stratified into two groups based on their baseline O₂ER (≤35.4% and \>35.4%) to evaluate whether higher O₂ER is associated with more pronounced physiological response to transfusion.


Eligibility Criteria:
Inclusion Criteria:

* Adult cancer patients, with anemia who required red blood cell transfusion, who were hemodynamically stable and without any respiratory support, with a central venous catheter in vena cava superior were included.

Exclusion Criteria:

* Acute bleeding, shock of any etiology, patient refusal to participate in the study, hematological malignancies, childhood (age under 18 years), and pregnancy.
A Study Investigating Tablet Formulations of Lu AF11167 in Healthy Subjects

The purpose of this study is to investigate the extent to which Lu AF11167 enters the bloodstream following tablet intake and the influence of food on uptake in healthy men and women

This study will be split into Part A and Part B. Part A will happen first and will look at new tablet formulations of the test medicine compared to a previously known formulation (reference tablet). The results from Part A of the study will be used to decide which formulation will be tested in Part B of the study. Part B of the study will look at the food effect, variability between participants, and absolute bioavailability of the test medicine i.e. how much of the test medicine is taken up by the body when dosed by mouth compared to when dosed once by injection directly into the vein. Safety and tolerability will be assessed throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) of ≥18.5 and ≤30.0 kg/m2
* (Part B only) Women of child-bearing potential will have a confirmed non-pregnant and non-lactating status

Exclusion Criteria:

* The subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the investigational medical product

Other in- and exclusion criteria may apply
Effects of Parental Holding on Pain Response in Young Children During Cystometry

Cystometry is essential for diagnosis and treatment plans by identifying the causes of lower urinary tract symptoms and objectively evaluating bladder functions in diseases such as neurogenic bladder, voiding dysfunction, and vesicoureteral reflux. Children may experience pain during this invasive procedure of inserting the urethra catheter. Furthermore, infants aged ≥ 6 months may feel pain from an unfamiliar and unnatural environment as they experience stranger anxiety. This experience can have a negative physical and emotional impact on children, and uncooperative behavioral reactions caused by pain can hinder the procedure. In this regard, parental holding is known as effective non-pharmacological procedural pain management in children. Although the International Children's Continence Society has advised performing cystometry while holding the infant as an effective non-pharmacological pain management method, there is insufficient evidence to support this. So, this study aimed to analyze the effect of parental holding on reducing pain in children during cystometry.

This is an experimental study in a randomized controlled pre-posttest design. During cystometry, participants in the experimental group are placed on the parents' laps and held in the parents' arms. Participants in the control group are laid down on the examination table. The behavioral (FLACC scale) and physiological (oxygen saturation and heart rate) pain responses are measured at three time points (immediately, 3 min, and 10 min after urethral catheter insertion).

Eligibility Criteria:
Inclusion Criteria:

1. The children aged 6-18 months.
2. The children who undergo cystometry for the first time.
3. The children who undergo cystometry with their parents.

Exclusion Criteria:

1. The child who is premature or has a low birth weight
2. The primary caregiver is not the participant's parent
3. The child who has unstable vital signs
4. The child is expected to have neurological or sensory impairments (e.g., spinal cord inflammation, spina bifida).
Neonatal Precursors of Neurodevelopment

The NEOPRENE project proposes to examine processes that are among the earliest precursors of cognitive functions and assess 1) the relationship between neonatal cognitive precursors and cortical structure, structural connectivity and functional connectivity at birth and 2) the relationship between neonatal cognitive precursors and neurodevelopment.


Eligibility Criteria:
Inclusion Criteria:

* Preterm newborn (born \< 34 weeks + 6days)

Exclusion Criteria:

* Brain injury
* Respiratory assistance on measurement day
* Infection on measurement day
* Sedation on measurement day
* Parents \< 18 years old or unable to give informed consent
A Phase I Study of TS-172 in Healthy Adult Subjects (Single and Multiple Doses)

A Phase 1, Single-Center, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending and Multiple Dose of TS-172 in Healthy Adult Subjects


Eligibility Criteria:
Inclusion Criteria:

1. Japanese healthy males aged 20 years or older but less than 40 years at the time of informed consent
2. Those with a BMI of 18.5 or more and less than 25.0 at screening test
3. Those who are able to receive the explanation before participating in the study, understand the content of the study, and provide written informed consent by the subjects themselves.

Exclusion Criteria:

1. Subjects who have any disease and are not considered healthy subjects based on the medical judgment of the principal investigator or sub-investigator.
2. Those who correspond to any of the following about bowel movements;

   * Repeated diarrhea (Bristol Stool Form Score \[BSFS\] score of 6 or higher) on a daily basis
   * Repeated constipation (no defecation for 2 days or more in a week) on a daily basis
3. Those who correspond to any of the following about bowel movements in the 7 days before administration;

   * Diarrhea on 2 or more days in 7 days
   * 2 or more days without a bowel movement in 7 days
4. Those who have a history of gastrointestinal ulceration
5. Those who correspond to any of the following about infection;

   * Positive for SARS-CoV-2 in the nucleic acid amplification test performed at the time of admission
   * Suspected of having COVID-19
Sedatives' Effects on Neurological Function in Patients With Eloquent Area Glioma

Sedation in the operating room, the Post Anesthesia Care Unit and the Intensive Care Unit is common and often necessary for patients with intracranial brain tumor. Repeated neurological function assessments is needed in those locations, especially in patients with tumors in or near eloquent regions, this is to monitor their neurologic performance to determine if there are alterations that require treatment. Some slowly infiltrative low-grade gliomas near eloquent regions do not show any detectable neurologic deficits, perhaps from reorganization, but with sedation by some sedatives such as benzodiazepine midazolam and anesthetic hypnotic propofol, the disease may seem much worse resulting in inappropriately aggressive treatment. This may be especially problematic in patients undergoing awake craniotomy for tumors in eloquent regions.

This is a single-center perspective study. Patients will be mildly sedated to keep them responsive and cooperative. Motor and sensory function will be evaluated before and after mild sedation. Specific benzodiazepine antagonist will be used if sedated by midazolam.

The purpose of this study is to observe if commonly used benzodiazepine midazolam exacerbates or unmasks motor and sensory function in patients with intracranial eloquent area gliomas.

Hypothesis:

mild sedation can unmasks or exacerbate motor and sensory deficits in patients with eloquent area glioma but not in non-neurosurgical patients/healthy volunteers. If the neurologic deficits induced by benzodiazepine agonist, then can be reversed by flumazenil.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-60 year-old
* American Society of Anesthesiology(ASA) status I\~II
* Elective craniotomy patients with supratentorial eloquent glioma diagnosed by MRI (In control group: volunteers without neuro-diseases)

Exclusion Criteria:

* Unable to comprehend and cooperate with the neurologic examination
* Impaired mental status
* Taking sedative drugs in the past 24 hours
* Taking pain reliever in the past 24 hours
* Drug and/or alcohol abuse
* Pregnant and/o lactating women
* Recurrent brain tumors
* Multiple brain tumors
* Accepting radiotherapy or chemotherapy
* Complicated with intracranial trauma and vascular diseases
* Complicated with grand mal epilepsy ( in midazolam group)
* Complicated with neuromuscular diseases
* Complicated with cutaneous paresthesia
Simulation Based Training in Colonoscopy

The aim of this study is to create simulation-based tests with credible pass/fail-standards for two different fidelities of colonoscopy models

1. virtual reality simulator
2. physical model simulator To create pass/ fail standards for certification

Twenty-five physicians (10 consultants with endoscopic experience and 15 fellows in the first year of fellowship without endoscopic experience) will be tested twice on each of the two different simulator models.

Metrics with discriminatory ability will be identified for both modalities. Reliability will be determined A pass/ fail standard will be determined and the concequences explored.

Eligibility Criteria:
Inclusion Criteria: For the two groups

Experienced endoscopists :

Having performed \>350 colonoscopy procedures

Novice endoscopists:

First or second year of fellowship in gastroenterology Having performed less than 3 colonoscopies

Exclusion Criteria: For the two groups

Experienced endoscopists:

Prior simulator training

Novice endoscopists:

Prior simulator training
Diagnostic Accuracy of Quantitative Flow Ratio

The aim of this study was to investigate the accuracy of quantitative flow ratio (QFR) for predicting fractional flow reserve (FFR) ≤0.80 in an independent core laboratory.

FFR is an invasive physiological index used to define coronary stenosis that causes ischemia. Several studies have suggested that FFR-based percutaneous coronary intervention (PCI) can reduce adverse clinical outcomes compared to angiography-guided PCI. Although FFR is highly recommended in current guidelines, it is underused in real-world practice. QFR is a method for evaluating fractional flow reserve FFR without the use of an invasive coronary pressure wire or pharmacological hyperemic agent.

The aims of this study were:

1. To investigate diagnostic accuracy of angiography-based QFR for hemodynamic assessment of coronary artery stenosis compared to pressure wire-based FFR.
2. To compare the diagnostic performance of QFR versus % diameter stenosis (DS) in identifying physiologically significant coronary artery disease (CAD) using FFR as the reference standard.
3. To identify factors affecting QFR accuracy.
4. To compare the coronary CT data with QFR.

Eligibility Criteria:
Inclusion Criteria:

* Patients suspected with CAD undergoing diagnostic coronary angiography with an indication for to perform invasive FFR

Exclusion Criteria:

* Suboptimal angiographic image quality for QFR analysis
* Primary myocardial or valvular disease
* Left ventricular ejection fraction ≤40%
* Patients with cardiogenic shock
Surgical Versus Nonsurgical Treatment for Spinal Stenosis

Lumbar spinal stenosis (a narrowing of spaces in the backbone that results in pressure on the spinal cord and/or nerve roots) is a condition that occurs frequently, particularly in the elderly. This condition can lead to significant pain and limit a person's ability to function. Moreover, doctors disagree about the best way to treat people with lumbar spinal stenosis.

In this study we will compare surgical treatment of lumbar spinal stenosis with nonsurgical treatment using physical therapy. The results of this study should help clarify which treatment strategies are the most effective for patients with lumbar spinal stenosis.

Lumbar spinal stenosis is a frequently encountered condition, particularly in the elderly, which can lead to significant pain and functional limitations. The prevalence of this condition is growing as the population continues to age. Substantial controversy exists regarding the management of lumbar spinal stenosis. Surgery has traditionally been the treatment of choice, although physicians typically recommend a trial of nonsurgical care prior to surgery. The most effective means of nonsurgical treatment has not been identified, although a "standard" regimen has been developed.

There is presently no evidence in the literature regarding the relative effectiveness of surgical versus nonsurgical treatment of lumbar spinal stenosis, or the efficacy of the standard nonsurgical treatment approach. This randomized clinical trial will compare surgical decompression versus nonsurgical treatment (i.e., physical therapy) of lumbar spinal stenosis. The results of this study should help clarify which treatment strategies are the most effective for patients with lumbar spinal stenosis.

Eligibility Criteria:
Inclusion Criteria:

* Imaging evidence of stenosis
* Unable to walk more than 1/4 of a mile
* No prior surgery for stenosis
* Consents to surgery
* Speaks English

Exclusion Criteria:

* Presence of dementia or organic brain syndrome
* Coronary artery disease, recent myocardial infarction, pulmonary or vascular disease
* Spondylolisthesis (\> 5 mm slippage)
* Severe osteoporosis
* Metastatic cancer
Upper Extremity paın and Ultrasound Use

The relationship between perinatologists' ultrasound use and upper limb joint pain will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Those who have received specialization training in the branch of perinatology and have completed their specialty in the branch and worked as a perinatologist
* Those who want to participate in the study

Exclusion Criteria:

* Patients with discomfort and operation in the upper limb prior to perinatology training
* Physicians in other branches
Axillary Block or Wide-awake Local Anesthesia for Complex Regional Pain Syndrome (CRPS) Following Common Hand Surgeries

Flare reaction, characterized by excessive erythema, stiffness, and edema postoperatively, can lead to complex regional pain syndrome (CRPS) when pain is present. This study compares flare and CRPS incidence following hand surgeries performed under regional anesthesia with axillary block (RAAB) and WALANT (Wide-Awake Local Anesthesia No Tourniquet).

This two-center prospective study included patients undergoing Dupuytren contracture (DC), DeQuervain tenosynovitis (DQS), carpal tunnel syndrome (CTS), and trigger finger (TF) surgeries under RAAB or WALANT. Diagnostic criteria for flare and CRPS (pain, weakness, scar issues, erythema, and swelling) were assessed, and comorbidities were noted. The incidence of flare reactions and CRPS was compared for RAAB and WALANT.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with and operated on for Dupuytren contracture (DC),
* Patients diagnosed with and operated on for De Quervain tenosynovitis (DQS),
* Patients diagnosed with and operated on for carpal tunnel syndrome (CTS),
* Patients diagnosed with and operated on for trigger finger (TF)

Exclusion Criteria:

* Patients operated under general anesthesia,
* Patients operated with other types of regional anesthesia (eg: supraclavicular block),
* Patients operated with other types of local anesthesia (only prilocaine or bupivacaine)
* Patients less than 3 months follow up