cyrilzakka/clinical-trials huggingface dataset:
Feasibility and Performance of Virtual Software for Virtual Bone Graft Planning in Cleft Patients

Objective: The investigators aim to compare the licensed Brainlab Iplan® software, considered the gold standard, to the 3D slicers and Blender freeware for the segmentation of the unilateral cleft defect, as well as the creation of individual 3D template for development of the bone graft.

Study design Retrospective, pilot study Patients presenting at the division of maxillofacial surgery at the AZ Sint-Jan Brugge-Oostende av (Belgium) or the 1st department of pediatrics at the USemmelweis (Hungary) for bone graft surgery of the unilateral cleft receive a complete routine work-up, including a cone-beam CT (CBCT). A single surgeon will run all the virtual planning steps with both the licensed software and the freeware. Timing of the four major steps will be measured with a digital chronometer (http://www.online-stopwatch.com/download-stopwatch/).

Ten children, 5 Belgian patients and 5 Hungarian patients, that already had a work-up and surgery for a unilateral cleft requiring a bone graft, will be planned. This based on the preoperative CBCT that is already present, by using both the licensed software and free software. The investigator will register patients' age, gender and cleft size and register the required time to complete the different planning steps, as well as list the number of actions to complete the planning, and the occurrence of software bugs. In addition, the learning effect will be examined through comparison of the different cases planned by the same surgeon. All patients will be planned twice with an interval of two weeks in order to measure intra-observer reliability. Moreover, a second surgeon will also plan the 10 cases to measure inter-observer reliability.

Main study endpoints The investigators hypothesize that the licensed software is more user-friendly, ensuring a significant shorter overall treatment planning time to create a model for accurate bone transfer from the iliac crest to the jawbone.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a unilateral cleft
* Patients of all genders
* Patients aged 7-12 years old
* Patients should have presented themselves at the division of maxillofacial surgery, at the participating hospital centers, for bone graft surgery
* Patients should have received standardized cone-beam computed tomography (CBCT) image acquisition as part of routine work-up, and all original DICOM files should be present
* Preoperative 3D virtual planning should be performed by the same investigator per center with both the licensed software and the freeware

Exclusion Criteria:

* All patients that do not fit the abovementioned description
* Patients with previous bone graft surgery
* Patients with posttraumatic deformity
* Patients with preprosthetic indication
Remote Monitoring of Patients With Functional Mitral Regurgitation Undergoing Mitraclip Transcatheter Repair

HERMES is a pilot study which aims at exploring the impact of remote monitoring in patients with severe functional mitral regurgitation undergoing transcatheter mitral valve edge-to-edge repair with the Mitraclip system.

The scope of the HERMES study is to investigate whether the information obtained by remote monitoring in patients with severe functional mitral regurgitation who have undergone transcatheter mitral valve edge-to-edge repair with the Mitraclip system may have the potential to guide treatment decisions at follow-up visits, and improve the quality of life. Candidates to the Mitraclip procedure on optimal medical therapy will be offered the opportunity to participate to the study by bringing home a tablet and a series of sensors and wearables to collect daily information on blood pressure, oxygen saturation, weight variation, heart rate, symptoms and compliance to therapy. These variables will be blinded, stored by the tablet and downloaded by the core institution at follow-up visits. Clinicians will be encouraged to use these data to guide their decisions, personalizing drug therapies and follow-up schedules to the individual patient's need. Patients that during the run-in phase (from enrollment to 30+-7 days) will have used the tablet for \>66% of the days will undergo the Mitraclip procedure and continue to keep the tablet for up to 12 months (active group). Patients that during the run-in phase (from enrollment to 30+-7 days) will have not used the tablet for \>66% of the days, will continue the study as a control group. Predefined clinical follow up assessments for collection of study endpoints will be at 1 month post Mitraclip, 6 months post Mitraclip and 12 months post Mitraclip. Quality of life, assessed by means of the SF36v2 questionnaire, will be assessed at enrollment, pre Mitraclip, at 1 month after Mitraclip and at 12 months after Mitraclip. A series of secondary endpoints, including 6MWT assessments and consumption of resources will be also assessed.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic while on optimal medical therapy (NYHA Class III-IV)
* Mitral regurgitation of functional etiology
* Suitable Mitraclip candidate
* Life expectancy \>12 months

Exclusion Criteria:

* Mitral regurgitation of primary etiology
* Refusal to sign the informed consent
* Dementia or neurological disorders that prevent the proper use of the tablet
* Inability to use the tablet, the sensors and/or the wearables, even with the assistance of family members
* Expected non-compliance with follow-up visits
* End-stage chronic kidney disease on dialysis
HF Patients With LVADs Being Treated With SGLT2i

The main purpose of this study is to observe outcomes of sodium-glucose co-transporter 2 inhibitors (SGLT2i) in heart failure (HF) patients with left ventricular assist devices (LVAD).

The exact mechanism of cardiovascular benefit from SGLT2i continues to be the source of further research. The investigators hypothesize that heart failure patients with LVADs will similarly benefit from the SGLT2i-associated natriuresis and diuresis, which in turn reduces preload. This is further associated with reduced heart failure readmissions and right ventricular failure. Additionally, the animal models indicating reduced cardiac work and remodeling in this population may benefit these patients as one of the goals of LVAD implantation is to reduce cardiac energy expenditure and promote remodeling and recovery in these patients.

This is a prospective, randomized controlled study to assess cardiac benefit of SGLT2i in 40 consecutive patients with heart failure undergoing LVAD implantation. After routine LVAD implantation, patients will be randomized 1:1 to one of two routine care arms: management with an SGLT2i \[empagliflozin 10 milligram (mg) daily or dapagliflozin 10 mg daily, based on formulary coverage\] or no SGLT2i. The patient's treating physician will be able to override randomization assignment if they determine that the assignment is not in the patient's best interest. SGLT2i management (if applicable) and follow-up care will be dictated by routine care. Data will be collected from the subject's medical record for 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. LVAD implantation
2. Have not already been prescribed management with an SGLT2i
3. Estimated glomerular filtration rate (eGFR) ≥ 30 milliliters(ml)/minute(min)/1.73 meter(m)2
4. Age ≥ 18 years-old
5. Able to provide informed consent

Exclusion Criteria:

1. Diagnosis of Type 1 diabetes mellitus
2. eGFR \< 30 ml/min/1.73 m2
3. Age \< 18 years-old
Repeatability of X-Ray, MRI, and Gait Analysis

The purpose of this preliminary substudy to the parent study "Aerobic Exercise Intervention for Knee Osteoarthritis" is to determine the repeatability and reproducibility of various measurement techniques.

The purpose of this preliminary substudy to the parent study "Aerobic Exercise Intervention for Knee Osteoarthritis" is to determine the repeatability and reproducibility of various measurement techniques. The study will enroll healthy volunteers. All participants will receive x-rays and MRI examinations of the knees. Walking characteristics will be evaluated in a Motion Analysis Lab; this will involve taping reflective markers to participants' skin and having them walk on a level surface and up and down stairs. All participants will be evaluated two times, with a 1-week period between evaluations.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* Previous knee injury, knee pain, or knee osteoarthritis
The Effects of Time Points to Cease Parenteral Nutrition and IGF-1 on Very Low Birth Weight Infants

This study aims to estimate short-term and long-term effects of time points to cease parenteral nutrition on very preterm infants, such as growth; to estimate the role of insulin-like growth factor 1 in the growth.

At present, it is unclear when to cease parenteral nutrition, the effects of cessation times on preterm infants' growth, and whether insulin-like growth factor 1 (IGF-1) has a mediation effect in the procedure that nutrients regulate the growth in preterm infants.

Therefore, a prospective cohort study was designed with the aims:

1. to estimate the association between the time to cease parenteral nutrition and the growth in very low birth weight;
2. to investigate the relationship between nutrient volume in parenteral nutrition and growth in very low birth weight;
3. to analyze the IGF-1 mediation effect between nutrient volume and growth regulations.

Eligibility Criteria:
Inclusion Criteria:

1. Infants with a birth weight less than 1500 grams
2. Infants admitted within 72 hours after birth
3. Infants born from July 1, 2023, to June 30, 2024
4. Written informed consent from parents or guardians

Exclusion Criteria:

1. Infants with congenital abnormality
2. Infants surviving \<7 days after birth
Comparison Between a 1L of Polyethylene Glycol+Ascorbic Acid as a Split Dose Bowel Preparation for Colonoscopy

Comparison between a 1L of polyethylene glycol+ascorbic acid as a split dose and oral sulfate solution bowel preparation for colonoscopy

study design: prospective, randomized, parallel, multi-center trial in 3 hospitals in Korea ( Seoul National University hospital, Seoul National University Bundang hospital, Seoul Metropolitan Government-Seoul National University )

patient inclusion criteria

- aged 20-75 adults (out-clinic patients) scheduled for colonoscopy for any indication within the normal process of care


Eligibility Criteria:
Inclusion Criteria:

* Adult out clinic patients scheduled for colonoscopy for any indication within the normal process of care

Exclusion Criteria:

* previous history of significant gastrointestinal surgeries (except for appendectomy)
* known or clinically suspicious Inflammatory bowel disease patients
* known or suspected ileus/ GI obstruction
* previous history of major cancer or currently on treating cancer
* Major cardiovascular disease, respiratory disease, liver, hematologic diseases with complication
* severe cognitive impairment / dementia / confusion state
* past history within the last 12 months or current episode of severe constipation severe constipation
* Regular use of laxatives or colon motility-altering drugs (i. e. more than 2 - 3 times per week) in the last 28 days prior to screening and/or laxative use within 72 hours prior to administration of the preparation)
* women who are pregnant or lactating
* known phenylketonuria, glucose-6-phosphate dehydrogenase deficiency
* those who were allergic to any preparation components.
* those who, in the opinion of the investigator, should not be included in the study for any reason
Negative Venous Line Pressure in a Miniaturised Cardiopulmonary Bypass Circuit (CPB)

Study to measure the ability of a 'fenestrated' venous line cannula to reduce the negative line pressure seen with kinetic-assist active venous drainage (KAVD) in a standard miniaturised cardiopulmonary bypass circuit and thereby increase the flow characteristics of the bypass pump.

To investigate whether a new venous drainage pipe (cannula) which has three sets of drainage holes (three-stage) compared with the standard two-stage cannula, or a three-stage which also has additional windows (fenestrations), can improve the drainage of blood into the circuit, reducing the negative pressure produced and increase the blood flow delivered to the patient. Patients who consent to participate will be randomly assigned to one of three types of venous cannula:

1. Standard venous cannulation with a two-stage venous cannula
2. The three-stage cannula (91437C, Medtronic)
3. The fenestrated three-stage cannula (MC2X, Medtronic)

Eligibility Criteria:
Inclusion Criteria:

* All patients over the age of 18 years of age scheduled to undergo isolated Coronary Artery Bypass Grafting (CABG) or isolated Aortic Valve Replacement (AVR), who are able and willing to consent.
* Consultant surgeon willing to operate using either Mini-CPB for CABG or AVR surgery.

Exclusion Criteria:

* Re-operation and emergency surgery
* Patients refusing or unable to provide informed consent
Effects of TENS on Myocardial Protection in Patients Undergoing AVR

Patients undergoing aortic valve replacement are randomized to receive TENS (transcutaneous electrical nerve stimulation) or sham stimulation at one arm for 30 min under various anesthetic conditions: no anesthesia (preanesthesia), sevoflurane or propofol anesthesia. Cardioprotective effects of TENS are compared through Langendorff rat heart perfusion system using plasma dialysate from patients.

Patients undergoing aortic valve replacement are randomized to one of six groups: preanesthesia-TENS (transcutaneous electrical nerve stimulation), preanesthesia-sham, sevoflurane-TENS, sevoflurane-sham, propofol-TENS, propofol-sham. Patients receive TENS or sham stimulation (without electrical pulse generation) at one arm for 30 min under no anesthesia (preanesthesia) or sevoflurane or propofol anesthesia.

In all patients, blood samples are obtained before and after TENS or sham procedure to make plasma dialysate to perfuse rat hearts subjected to ischemia-reperfusion injury through Langendorff system.

Cardioprotective effects are determined by comparing infarct sizes of rat hearts perfused with human plasma dialysate, which reflects cardioprotective effects of TENS in human subjects. By comparing infarct size differences, the myocardial protective effects of TENS in various anesthetic conditions can be determined in human subjects undergoing aortic valve replacement.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing aortic valve replacement

Exclusion Criteria:

* co-medications: metformin, nitroglycerine, nicorandil
* discomfort at TENS or loss of intact skin
* uncontrolled hypertension or diabetes mellitus
* severely impaired renal or hepatic function
* peripheral vasculopathy or neuropathy
* did not consent to participate
* pregnancy
Addition of Ondansetron to Ongoing Antipsychotic Treatment for Schizophrenia

This study will examine the effects of ondansetron on auditory nerve activity in people with schizophrenia who are being treated with new antipsychotics.

Schizophrenia is a devastating brain disorder. Most people with schizophrenia have difficulty filtering out unimportant auditory information. They have an inability to appropriately inhibit, or gate, sensory information that enters the ear. Standard treatments do not address this problem. When the drug ondansetron is taken in addition to typical antipsychotic drugs, P50 auditory gating improves. However, ondansetron has not been used with some of the newer, atypical antipsychotic drugs. This study will evaluate the effect of combining ondansetron with newer, atypical antipsychotic drugs on P50 auditory gating.

Participants in this double-blind study will be randomly assigned to receive either ondansetron or placebo for 3 months. Upon completion of the first 3 months, participants will be crossed over to receive the other treatment for an additional 3 months. All participants will also take an atypical antipsychotic drug, including olanzapine, quetiapine, or aripiprazole. Auditory gating will be assessed using computerized cognitive testing and functional magnetic resonance imaging (fMRI) at baseline and Months 3 and 6. Vital signs and evoked potentials will be assessed at Weeks 1, 3, and 6. Clinical symptoms and cognitive abilities will also be evaluated to determine the effectiveness of ondansetron.

Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-IV criteria for schizophrenia
* Stable, chronic schizophrenia
* Currently taking atypical medications
* Use of effective form of contraception throughout study

Exclusion Criteria:

* History of any alcohol or drug abuse within 3 months of study start date
* Any other major neurological disorders
* History of or current head trauma
* Any medical conditions affecting the central nervous system
* Current epilepsy, asthma, migraine headache, previous myocardial infarction, stroke, diabetes, hypertension, narrow angle glaucoma, or neuromuscular illnesses
* Pregnant
Schroth Treatment and Proprioception Pathway

Adolescent idiopathic scoliosis (AIS): It is the type of structural scoliosis whose etiology is unknown and is most common in female individuals between the ages of 10-18. In addition to spinal deformity, postural asymmetry, proprioceptive sense, and dysfunctions in the vestibular and vestibulospinal systems can also be seen in AIS. The Schroth method is a scoliosis-specific exercise approach that uses postural, scoliosis-specific sensorimotor and breathing exercises and is widely used in scoliosis rehabilitation. The treatment program consists of scoliotic posture correction with the help of exteroceptive and proprioceptive stimulation and mirrors, isometrics and other exercises to lengthen or strengthen asymmetric muscles while maintaining a certain breathing pattern. Various studies have shown that the Schroth method improves Cobb angles, slows curve progression, reduces the need for surgery, increases back muscle strength, and increases respiratory function. However, although the Schroth method is widely used in AIS rehabilitation, no studies have been found investigating the effects of Schroth exercises on proprioceptive sense and corticospinal pathways.

The purpose of this study is to examine the effect of the Schroth method on proprioceptive sense and corticospinal pathways in individuals with AIS.

The purpose of Schroth exercises is to rotate, lengthen and stabilize the spine in a three-dimensional plane. It is aimed to increase the patient's body awareness, to rotate the spine by inflating the deflated parts of the lungs with breathing, and to correct muscle posture asymmetries.

With different stimuli from the environment, some changes occur in the reorganization ability and strength of neurons and the synapses that neurons make with each other. This phenomenon, which is necessary for the adaptation of the organism to the environment, is called neuroplasticity. Thanks to neuroplasticity, some differences in brain structures are observed. Thanks to Schroth exercises, there is an intense proprioception sensory input to the body. At the same time, muscle strengthening occurs with controlled loading. Schroth exercises produce some effects on the brain with these features. In the study, the possible effects of Schroth exercises on the brain will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Being a female individual between the ages of 10-18
* Being diagnosed with AIS
* Cobb angle should be maximum 25º
* All participants do not have any disease that affects the nervous system.
* All participants must use their right hand as the dominant hand
* All participants do not have any chronic disease requiring the use of any neurological or psychiatric medication.
* Permission to participate in the study is given by the parents of all participants.

Exclusion Criteria:

* MRI of individuals who do not have any mental problems, neurological, psychiatric, muscular, rheumatic or orthopedic diseases will be included in the study.
SBS DISK- Creation of a Quality of Life Tool for Short Bowel Patients Compared with a Validated Quality of Life Questionnaire (SBS QoL)

Patients with short bowel syndrome have an impact on their quality of life because they need temporary or permanent parenteral nutritional support. The quality of life of these patients has been the subject of several studies and assessment tools exist, such as the Short Bowel Syndrome Quality of Life (SBS QoL). This tool may seem complex and tedious to use in everyday practice. However, it is important to regularly assess the quality of life of these patients. This is why the investigators are proposing to create a new tool for more rapid assessment of the quality of life of patients with short bowel syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or over
* Patient able to read and speak French
* Patient suffering from short bowel syndrome

Exclusion Criteria:

* Known cognitive disorders
Study Of The Safety Of CE 224,545 And Methotrexate In Patients With Rheumatoid Arthritis

CE 224,535 is being developed for the treatment of rheumatoid arthritis. The purpose of this study is to evaluate the safety and tolerability of CE 224,535 after 4 weeks of treatment in subjects with rheumatoid arthritis already receiving methotrexate


Eligibility Criteria:
Inclusion Criteria:

* Adults patients with rheumatoid arthritis
* Patients who have received stable weekly doses of oral methotrexate (5 to 25 mg/week administered as a single dose) for a minimum of 28 days (4 weeks/4 doses)

Exclusion Criteria:

* History of chronic infectious disease such as genitourinary, pulmonary or sinus infections.
* Any current or known malignancy or history of malignancy within the previous 5 years
* Pregnant or lactating women; women of child-bearing potential who are unwilling to unable to use an acceptable method of birth control during the study
Measurement of Core Temperatures During Therapeutic Hypothermia

The purpose of this study is to determine that the measurements of rectal and bladder temperature are correctly consistent with core temperature by using the pulmonary artery catheter during therapeutic hypothermia; rapid cooling, maintenance, and slow rewarming phase.

The guidelines of therapeutic hypothermia(TH)are rapid cooling, from normothermia to mild hypothermia(32\~34 degree), maintenance, and slow rewarming phase. If core temperature maintained below 32 degree during TH, som complications will be developed, such as arrythmia, hypotension, cold diuresis, coagulopathy, and so on. Therefore correct measurement of core temperature during TH is very important process for successful post cardiac arrest care. we will know that rectal or bladder temperature are really reflect the core temperature during TH for post cardiac arrest care, especially rapid cooling phase, maintenance phase, and slow rewarming phase, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Out of cardiac arrest patient who is 18 years old.
* Mean arterial pressure must be over 65 mmHg after return of spontaneous circulation.
* Family consent to this study.

Exclusion Criteria:

* In hospital arrest.
* Arrest due to trauma
* Arrest due to intracranial hemorrhage.
* Below 30 degree at initial core temperature.
* Pregnancy.
* Family do not agree with our study.
* Active bleeding patient.