cyrilzakka/clinical-trials huggingface dataset:
Characterization and Management of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD)

The goal of this clinical trial is to improve the treatment of hepatic steatosis associated with obesity with pharmacological and nutritionnal approaches. The main question it aims to answer is:

Does an individualized nutritionnal approach with a dietician combined with medication targeting obesity is the most efficient way to treat hepatic steatosis associated with obesity?

Participants will either participate in one of three groups:

* Nutrition: Participant will only have a regular follow-up with a registered dietician;
* Nutrition + Semaglutide: Participants will start a new medication targeting obesity and will have a regular follow-up with a registered dietician;
* Semaglutide: Participants will start a new medication targeting obesity.

Participants in each group will be followed during a year for 4 timepoints (0, 3, 6 and 12 months). Blood and feces samples, anthropometric measures, transient elastography measurements and health questionnaires will be assessed at each timepoint.

The nutritionnal intervention targeting hepatic steastosis associated with obesity will use conclusions from a systematic review we conducted on nutritionnal approaches to treat liver steatosis.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 30 and 50 kg/m2;
* Stade 2 or 3 (S2 or S3) hepatic steatosis with or without liver fibrosis.

Exclusion Criteria:

* Type 1 diabetes diagnosis;
* Alcohol consumption exceeding recommendations \[\>140 g/week (women) and \>210 g/week (men)\];
* Known chronic hepatic disease non-steatotic at the entry of the study (Wilson's disease, hemochromatosis, alpha-1-antitrypsin deficiency, viral hepatitis, auto-immune hepatitis, etc.);
* Pharmacological treatment targeting obesity active or ended in the last 3 months;
* Bariatric surgery;
* Gastro-intestinal pathologies (GI cancers, IBD, etc.);
* Capsulated probiotics consumption;
* Antibiotic treatment in the last 3 months;
* Pregnancy;
* Cirrhosis diagnosis (hepatic decompensation).
Clinical Application Comparison of Two Femtosecond Laser Systems

The goal of this clinical trial is to compare the perioperative parameters of femtosecond laser-assisted cataract surgery (FLACS) using two laser systems.

Participants will:

Undergo FLACS using LenSx or Z8 femtosecond laser system Visit the clinic before the operation and 1 day, 1 week, and 1 month after the operation for checkups and tests Complete clinical measurements and dry eye questionnaires


Eligibility Criteria:
Inclusion Criteria:

1. Chinese Han patients aged 40 years or older
2. clinical diagnosis of age-related cataracts;
3. underwent FLACS with insertion of a posterior chamber IOL for the first eye.

Exclusion Criteria:

1. coexisting macular pathologies such as epiretinal membrane, macular hole or edema, or age-related macular degeneration. Patients with OCT scans of poor quality were excluded;
2. preoperative flare of more than 15ph/ms11, ECD\<2000cells/mm2 or any other corneal pathologies;
3. coexisting serious ocular diseases including uveitis, uncontrolled glaucoma, optic atrophy , amblyopia, retinopathies, or inflammatory pathology of the eye;
4. history of intraocular trauma, surgery, or retinal laser procedures;
5. usage of systemic or topical steroids or NSAIDs within one month prior to surgery;
6. patients with diabetes or any other systemic diseases that might confound the results or increase the risk for postoperative inflammation;
7. intraoperative complications such as capsule tear, hyphema, vitreous loss, iris manipulation, or miosis after laser pre treatment requiring intracameral injection of epinephrine;
8. ocular conditions contraindicating FLACS including poorly dilated pupils (\<5.0mm), narrow palpebral fissure, small hyperopic eyes with steep cornea (difficult to achieve suction), severe conjunctival chalasis, nystagmus, or lack of cooperation;
9. potentially pregnant women;
10. known sensitivity to concomitant medications used during perioperative period, participation in other clinical trial during the time of visit, or poor cooperation in diagnostic tests or non-compliance at follow-up.
Assessment of CSF Shunt Flow With Thermal Measurements B

This study evaluates the performance of a non-invasive thermal measurement device for assessing CSF shunt flow. Patients with an existing implanted shunt and symptoms of shunt malfunction will be evaluated with the study device.

Patients with an existing implanted ventriculoperitoneal (VP) shunt and who are experiencing shunt malfunction symptoms will be recruited by the clinical investigators at each investigational site in accordance with the inclusion and exclusion criteria. Assessment of shunt flow will be performed non-invasively with the study device; physician and clinical staff will be blinded to the device result. Standard-of-care assessment of shunt function will be performed and surgical intervention will occur based on the judgement of the treating neurosurgeon without the use of study device data. This trial will evaluate the ability of the study device to identify shunt malfunctions.

Eligibility Criteria:
Inclusion criteria

1. Existing ventriculoperitoneal CSF shunt on which the patient is dependent
2. At least one symptom of shunt malfunction as determined by the investigator, such as but not limited to seizure, fever, headache, vision problems, dizziness, disorientation, confusion, vomiting, lethargy, irritability, difficulty waking or staying awake, swelling along shunt tract, enlargement of head, loss of balance, gait disturbance, and loss of sensory or motor function
3. Suspicion of shunt obstruction warrants the performance of a test for this condition in the investigator's judgement
4. Region of intact skin overlying an unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device
5. Available for follow-up for up to seven days
6. Signed informed consent by patient or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as "surrogates" in this protocol)
7. Verbal assent by minors four years of age and older who are able to understand the study and communicate their decision

Exclusion criteria

1. Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected obstruction
2. Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed
3. Presence of an interfering open wound or edema over any portion of the shunt
4. Patient-reported history of adverse skin reactions to adhesives
5. Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable
6. Participation in the study will interfere with, or be detrimental to, administration of optimal health-care to the subject
7. Prior enrollment in this study (multiple main study enrollments of the same patient are disallowed)
8. Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study
A Twelve Week Study of Virtually Supervised Mouth Rinse and Flossing

The purpose of this study is to evaluate the efficacy of brushing, flossing, and rinsing with an alcohol containing essential oil mouth rinse; brushing and flossing; versus brushing and rinsing with an alcohol containing essential oil mouth rinse; and brushing only for the prevention and reduction of plaque and gingivitis.


Eligibility Criteria:
Inclusion Criteria:

* Able to read and understand (participants capable of reading the documents)
* Adequate oral hygiene (that is brush teeth daily and exhibit no signs of oral neglect)
* Negative pregnancy urine tests (females of childbearing potential only)
* Females of childbearing potential must be using a medically-acceptable method of birth control for at least one month prior to Visit 1 and agree to continue using this method during their participation in the study
* A minimum of 20 natural teeth with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, or third molars will not be included in the tooth count
* A minimum of 10 percent (%) bleeding sites based on the expanded bleeding index (BI)
* Participants will have evidence of some gingivitis; there will be no minimum or maximum mean MGI score for gingivitis or TPI score for plaque; mild to severe gingivitis and mild to moderate periodontitis
* No more than 3 sites having pocket depths of 5 millimeter (mm) and no sites that are greater than 5 mm in depth

Exclusion Criteria:

* History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes, mouth rinses and red food dye; Known allergy or sensitivity or history of significant adverse effects to any of the investigational product and/or product ingredients (or other ingredients in the products)
* Dental prophylaxis within four weeks prior to Screening/Baseline visit
* History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
* Use of antibiotics, anti-inflammatory or anticoagulant therapy during the study or within the one month prior to the Baseline exam. Intermittent use of certain anti-inflammatory medication is acceptable at the discretion of the investigator
* Suspected alcohol or substance abuse (example., amphetamines, benzodiazepines, cocaine, marijuana, opiates
Describing Treatment Outcomes and Responses in Lymphoma-associated Hemophagocytic Lymphohistiocytosis

The purpose of the study is to describe Hemophagocytic lymphohistiocytosis (HLH) in patients with lymphoma to identify possible therapeutic strategies to improve overall survival of the patients with lymphoma associated hemophagocytic lymphohistiocytosis.

Retrospective, multi-institutional study focused on describing the clinical features, laboratory parameters, treatments, and outcomes among individuals presenting with HLH in the setting of a lymphoma

Eligibility Criteria:
Inclusion Criteria:

* Patients with lymphoma that are fulfilling at least one of the following:

A. Meeting 5 of 8 HLH-2004 diagnostic criteria OR B. Are OHI index positive (sCD25\>3,900 U/mL and ferritin\>1,000 ng/mL)

Exclusion Criteria:

* Patients developing HLH\> 1 month after lymphoma diagnosis (for aggressive lymphomas)
* Patients with incomplete treatment and response documentation
Implementation of an Evidence Based Smoking Cessation Strategy (SMOCC) for Patients With COPD in Primary Care

A controlled study demonstrated that a smoking cessation protocol in routine primary care, specifically targeted at patients with COPD (SMOCC), doubled the quit rates. The protocol was tested under optimal trial conditions, but it is unclear if a large-scale implementation strategy is (cost-)effective. Therefore the present study investigates a large scale implementation strategy in a 2-armed community intervention trial. The research question is how (cost-)effective this implementation strategy is compared to usual implementation procedures.

COPD is an increasing cause of death and morbidity and smoking is its primary cause. Professional smoking cessation treatment is very cost-effective and therefore recommended by national guidelines. A controlled study demonstrated that a smoking cessation protocol in routine primary care, specifically targeted at patients with COPD (SMOCC), doubled the quit rates. The incremental cost-effectiveness ratio (ICER) was Euro 1012 showing that the protocol was cost-effective. The protocol was tested under optimal trial conditions, but it is unclear if a large-scale implementation strategy is (cost-)effective. Therefore the present study investigates an implementation strategy in a 2-armed community intervention trial. General practices (N=150, 2700 smoking patients with COPD) will be randomly allocated to the intervention or control condition. In the control condition the usual dissemination strategy of distributing guidelines and subsequent products through the professional channels (journals, postgraduate education) will take place. In the intervention condition a multifaceted implementation strategy wil be executed aimed at support of the general practice team (outreach education by a facilitator, support for detecting smoking patients with COPD, provision of patient education materials, help desk/website, telephone and e-mail reminders). The research question is how (cost-)effective this implementation strategy is compared to usual implementation procedures. Primary outcome measures will be biochemically validated smoking abstinence at 12 and 18 months. Secondary outcome measures will be counseling contacts and counseling behaviour of professionals and cessation attempts of patients. A process analysis and evaluations by patients and professionals are an integral part of the study. A cost-effectiveness analysis taking a health care sector perspective will be performed and will show the expected costs per practice and an incremental cost-effectiveness ratio (ICER). The study will last 34 months, the intervention period will take 18 months per practice.

Eligibility Criteria:
Inclusion Criteria:

* COPD
* Smoking
* Age 40 years or over

Exclusion Criteria:

* Under control of lung specialist
* Not Dutch-speaking
* Serious physical of psychiatric comorbidity
* Under 40 years of age
Evaluating the Clinical Effectiveness of "Endotracheal Tube Position Anomaly Alerting System"

The goal of this clinical trial is to determine whether the Endotracheal Tube Position Anomaly Alerting System (ETPAAS) effectively reduces the duration of endotracheal tube malposition in patients admitted to the intensive care unit (ICU). Additionally, the study will assess the clinical impact, usability, and user satisfaction of ETPAAS.

The main questions it aims to answer are:

* Does ETPAAS reduce the duration of endotracheal tube malposition?
* What are healthcare workers' perspectives on the usability and satisfaction of ETPAAS?

Participants will receive standard care, with or without ETPAAS, in the intensive care unit.

Researchers will evaluate the duration of endotracheal tube malposition. Healthcare workers will complete a questionnaire assessing the usability and satisfaction of ETPAAS.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the intensive care unit
* At least 18 years old

Exclusion Criteria:

* Patients disagree to participate in the study
Upper Extremity Robot-Assisted Therapy in Stroke Patients

Upper extremity hemiparesis is one of the most common symptoms after stroke. Robot-assisted therapies have been used as an approach to rehabilitation of upper extremity hemiplegia in recent years. Robot-assisted therapy is an approach to post-stroke rehabilitation that uses robotic devices to provide motor or task-oriented training to patients. When the literature is examined, there are studies showing that robot-assisted therapies are similar or superior to conventional methods. In order to provide the most effective rehabilitation approach in upper extremity robots, it is suggested that it may be more accurate to consider the robotic device as a training platform consisting of various therapeutic techniques and principles, not as a tool alone. A robotic system will be used to overcome the disadvantages of the existing robotic systems in the literature such as not providing support to the patient at the time of need, not providing fluidity in shoulder movements by not taking into account the scapulohumeral rhythm in upper extremity movements, long installation times, and ignoring task-oriented training. The system to be used is a self-aligning exoskeleton system for robot-assisted upper extremity rehabilitation. The system provides safe and versatile rehabilitation at increasing intensity and also allows for objective assessments. The aim of this clinical study was to evaluate the efficacy of robot-assisted upper limb rehabilitation in stroke patients.


Eligibility Criteria:
Inclusion Criteria:

* Spasticity of the upper extremity muscles is 2 or less according to the Modified Ashworth Scale
* Stroke patients with a Mini Mental State Examination score of 24 and above will be included in the study

Exclusion Criteria:

* Have a neurological disease other than stroke that may affect upper extremity movements
* Surgery or botox application for upper extremity spasticity in the last 6 months
* History of upper extremity fracture or surgery
* Attending another rehabilitation program
* Individuals who do not agree to participate in the study and do not give written informed consent will be excluded from the study.
A Study to Collect Information About the Use of Redifferentiating Medications as a Standard Treatment for Thyroid Cancer

The purpose of this study to learn more about the use of redifferentiating medications as a standard treatment for radioactive iodine/RAI-refractory thyroid cancer. This study is a registry study.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old at time of consent

Inclusion Criteria:

* Patients diagnosed with RAI refractory thyroid cancer or unlikely to respond to RAI.
* Patients who will receive redifferentiation agents prior to planned diagnostic and/or therapeutic use of radioactive iodine as part of routine clinical care.
* Patients who have never received redifferentiation agents outside of a clinical trial or have received redifferentiation agents in the context of a clinical trial will be enrolled after the clinical team has decided to proceed with a redifferentiation agent as part of routine clinical care prior to diagnostic and/or therapeutic radioactive iodine administration.
* Patients previously treated with redifferentiation agents as part of clinical care prior to diagnostic and/or therapeutic radioactive iodine administration who are willing to provide retrospectively collected data surrounding the time of the previous treatment and will provide prospective data from the time of consent.

Exclusion Criteria:

* RAI refractory thyroid cancer patients that will receive redifferentiation agents prior to diagnostic and/or therapeutic use of radioactive iodine as part of a prospective clinical trial.
Electromagnetic Transduction Therapy on Osteoarthritis in the Foot and Ankle

The purpose of this study is to determine if Electromagnetic Transduction Therapy (EMTT) is a viable treatment option in patients with osteoarthritis of the foot and/or ankle.


Eligibility Criteria:
Inclusion Criteria:

• Men and women with osteoarthritis of the foot and/or ankle confirmed via radiographs.

Exclusion Criteria:

• Pacemaker, active cancer, shrapnel, metal in eye, implantable devices that are not compatible with MRIs, concurrent foot or ankle condition or injury, prior foot or ankle surgery for osteoarthritis, steroid, platelet rich plasma, or hyaluronic acid injection within 2 months of the treatment.
Study of Inhaling Carbon Monoxide to Treat Patients With Intestinal Paralysis After Colon Surgery.

Post operative ileus (POI), a temporary paralysis of the intestines, is a serious health care problem. It normally occurs in all patients after surgery to the abdomen but in some cases can result in serious complications. The objective of this study is to determine if inhaling very low doses of carbon monoxide (CO) before and after colon surgery will shorten the duration of normal POI and/or prevent the development of POI complications in patients undergoing colon surgery.

A preliminary study will be conducted in six healthy volunteers to monitor for blood levels and adverse effects that occur at 3 different doses of inhaled CO to establish a safe dose for patients in the main trial. For the main trial, patients requiring surgery to their colon will be assigned randomly to receive one hour treatments of either CO or oxygen by face mask before and after their operation. Length of normal POI and occurrence of POI complications will be compared between the two groups. Side effects that occur from inhaling CO or oxygen will also be recorded.

We hypothesize that inhaling CO before and after colon surgery will shorten the length of normal POI and decrease the occurrence of POI complications with minimal side effects.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, age \> 18 years.
* Women must be using acceptable contraceptives, post-menopausal or surgically sterile.
* No prior smoking history.
* BMI between 16 and 30 inclusive.
* No significant abnormalities on history, physical examination or laboratory parameters.

Exclusion Criteria:

* Exposure to any carbon monoxide source during the 48 hours prior to the study day or occupational exposure to CO.
* Significant disease or disorder (as explained in Study B).
* Complete bowel obstruction.
* Intra-abdominal inflammation (diverticulitis, inflammatory bowel disease, colitis).
* Retroperitoneal hematomas.
* Known GI motility disorder.
* Underlying lung disease such as pneumonia, asthma or COPD.
* Sepsis.
* Planned pregnancy, already pregnant or breastfeeding.
* Electrolyte disturbance (hypokalemia, hypomagnesemia, hyponatremia).
* Significant opioid and laxative use 4 weeks prior to surgery.
* Anti-inflammatory use 2 days prior to surgery.
* Drugs such as antacids, Coumadin, amitriptyline, chlorpromazine.
* Baseline oxygen saturation \<92% on room air.
* Baseline blood level of COHb \>2%.
* Baseline hemoglobin \<90 g/dL.
* Participation in another clinical trial within 2 months prior to study.
Comparing Patient Satisfaction & Stress Distribution on Mandibular Ridge by Three Posterior Occlusal Scheme in Complete Denture

In this randomized clinical trial to compare the patients' satisfaction of complete dentures with different occlusal forms, after simple randomized sampling of 15 participant that will be signed informed consent and their latest teeth was extracted 3 month ago, will be selected. For each participant, it will be made 3 set of complete dentures that are variable in occlusion only. During the study, dissatisfied participants can leave it. Each set will be inserted for 1month in 5 participant randomly. The participants will be examined in two stages, after a day and after a week. At the end of month the questionaire will be filled out and the pressure under the mandibular denture base will be measured with the pressure sensors. Then the second and third denture will be inserted simultaneously.


Eligibility Criteria:
Inclusion Criteria:

* edentulous patients
* at least 3 month ago the latest teeth was extracted
* ideal jaw relation
* signing the informed consent

Exclusion Criteria:

* uncontrolled systemic disease
* mentally problem
* dissatisfaction for keeping on the study
Repeatability and Feasibility of Infant Spirometry

This is a study examining repeatability and feasibility of a new method for measurement of lung function in babies. A flexible vest is placed around the torso of the baby, and changes in tidal volume and flow is measured. The study will enable a better understanding of the usefulness of this equipment in a neonatal intensive care unit. The equipment is made by VOLUSENSE Norway AS, and marketed under the name FloRight. The equipment is owned by Volusense Norway AS during the study period.


Eligibility Criteria:
Inclusion Criteria:

* Being a Term born and preterm born babies

Exclusion Criteria:

* Being in an unstable clinical condition