cyrilzakka/clinical-trials huggingface dataset:
Brain Function Predictors And Outcome Of Weight Loss And Weight Loss Maintenance

By doing this study, researchers hope to learn whether a person's motivation for food is different after he or she loses weight, and if imaging techniques such as fMRI can be used to predict whether the person will maintain that weight loss over time.


Eligibility Criteria:
Inclusion Criteria:

* BMI equal to or greater than 30 kg/m2 or 18 to 24.9
* declaration they do not have plans to move out of the Greater Kansas City area for at least 1 year
* willingness to be randomized
* Individuals undergoing weight loss will have to present written approval from a licensed physician that they are healthy enough to participate in a program of moderate diet restriction and moderate physical activity.

Exclusion Criteria:

* Participation in a research project involving weight loss or PA in the previous 6 months, as these proximal experiences may impact the results of this study.
* Subjects who smoke
* Subjects who use special diets (i.e. vegetarian, Adkins, etc.), use medications that affect metabolism (i.e. thyroid, beta blockers), use medications that affect appetite (i.e. Meridia) or cannot exercise (i.e. walk).
* Exhibit signs of eating disorders, restraint, depression
* Participant has any metabolic disease that would affect energy balance (e.g. diabetes mellitus or hypothyroidism).
* Individuals who report being pregnant during the previous 6 months, are lactating, or planned pregnancy within 12 months
* Individuals who are not weight stable (± 4.5kg) within the previous 3 months or have more than 500 kcal/wk of planned physical activity
* Serious medical risk such as type 1 diabetes, cancer, recent cardiac event (i.e. heart attack, angioplasty, etc.)
Safety and Efficacy of Remote Ischemic Conditioning Combined EDAS on Ischemic Moyamoya Disease

Encephaloduroarteriosynangiosis (EDAS) is widely used as an indirect technique for treatment of moyamoya disease. Nevertheless, this indirect surgery tends to establish insufficient collateral circulation in most adult MMD patients. Nowadays, there is a lack of adjuvant therapies for improving collateral circulation induced by indirect revascularization. This study aims to explore whether remote ischemic conditioning can improve the collateral circulation after indirect revascularization.

Encephaloduroarteriosynangiosis (EDAS) is widely used as an indirect technique for treatment of moyamoya disease. Nevertheless, this indirect surgery tends to establish insufficient collateral circulation in most adult MMD patients. Nowadays, there is a lack of adjuvant therapies for improving collateral circulation induced by indirect revascularization. Remote ischemic conditioning (RIC) is a noninvasive approach protecting the brain by inflating and deflating blood-pressure cuff placed on the upper limbs. It has been confirmed to improve cerebral perfusion by promoting angiogenesis and arteriogenesis in ischemic animal brain. In addition, daily remote ischemic conditioning is a promising technique to ameliorate chronic cerebrovascular disease like intracranial atherosclerotic stenosis, small-vessel disease.

Thus, this study aims to explore whether remote ischemic conditioning can improve the collateral circulation after indirect revascularization.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who were diagnosed as moyamoya disease by the diagnostic criteria recommended by the Research Committee on MMD of the Ministry of Health and Welfare of Japan in 2012.
2. Suzuki stage: 2-5 stage
3. Age: between 18 and 65 years old
4. Subjects present with ischemic stroke or transient ischemic attack.
5. Subjects who plan to accept the first EDAS surgery.
6. Informed consent obtained from patient or patient's surrogate

Exclusion Criteria:

1. Acute ischemic stroke occurred within one month.
2. Suffered Intracranial hemorrhage before
3. Subjects with large infarction spread widely over the territory of a main arterial trunk
4. Aneurysms in the main arterial trunk
5. Severe cardiac diseases like atrial fibrillation，valvular disease，heart failure, infective endocarditis and so on.
6. Malignant tumors or severe disordered function of the heart, lung, liver or kidney.
7. Severe hemostatic disorder or severe coagulation dysfunction.
8. Uncontrolled diabetes mellitus with a serum fasting blood glucose level\>300 mg/dL, or requires insulin; hypertension with a systolic blood pressure over 180 mmHg or a diastolic blood pressure over 110 mmHg.
9. Severe injury on upper limbs.
10. Pregnant or lactating women.
11. Life expectancy is less than 3 years.
12. Patients who are not suitable for this trial considered by researchers for other reasons
Pharmacokinetics of Levetiracetam (Keppra) in Neonates

The primary objective of this study is to determine the pharmacokinetic profile of a loading dose of intravenous levetiracetam, given for clinical reasons, in term and late preterm infants with seizures. Secondary objectives are to evaluate the safety and efficacy of levetiracetam in term and preterm infants with seizures.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age ≥ 32 weeks
* Postnatal age ≤ 30 days
* Birth weight ≥ 2000 grams
* Admitted to the NICU at Cincinnati Children's Hospital or Good Samaritan Hospital
* Clinical or electrographic seizures of any etiology
* Seizures or seizure prophylaxis requiring treatment with levetiracetam
* Parental consent obtained

Exclusion Criteria:

* Infants with renal insufficiency indicated by serum creatinine \> 2.0 at any time
* Infants who have previously received levetiracetam
* Parents refuse consent
* Attending physician does not wish the infant to be enrolled in the study
* Infants who are currently receiving an investigational drug
Effects of Low and High Intensity Exercise in Improving Working Memory Among Students With Anxiety Symptoms

Anxiety levels among the younger generation especially students have been increasing drastically in recent years. This severely affects a student's academics as previous studies have shown a strong correlation between high anxiety levels and poor working memory. Working memory, also known as short term memory is an important component in studying as it aids in holding important information needed to understand following information for a short period of time. This concerning phenomenon has drawn the attention of researchers to find solutions to this issue where recent studies have found physical exercise to contribute in the improvement of cognition which also includes working memory. Hence, the aim of this study is to compare the effects of low and high intensity exercises on working memory among students with high anxiety levels. Thirty female undergraduate students from UTAR with relatively high levels of anxiety will be conveniently sampled using Beck Anxiety Inventory. Participants will then be randomly allocated into 2 groups to undergo low and high intensity exercise on a treadmill according to Balke's Protocol. 2 memory assessments involving Verbal Memory Task will be conducted for each participant before and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Female students (Age group: 18-25 years)
* Participants with mild to severe anxiety levels (Score of \>8)

Exclusion Criteria:

* Participants with Cardiorespiratory problems (e.g. Asthma, Congestive heart disorders) or severe Musculoskeletal problems that prevent them from carrying out any physical exercise or advised by personal physician not to.
* Participants that have had a recent head injury (recent 5 years)
Postoperative Analgesia After Video-Assisted Thoracoscopic Surgery

Video-assisted thoracoscopic surgery (VATS) is a commonly performed minimally invasive procedure that has lead to lower levels of pain. However, VATS require analgesia that blocks both visceral and somatic nerve fibers for more effective pain control.

In this study investigators will compare the analgesic effect of ultrasound guided erector spinae plane block (ESPB) and thoracic paravertebral block (TPVB) after VATS.

All patients will be assessed preoperatively by careful history taking, full physical examination, laboratory evaluation and other appropriate investigations.

At the preoperative visit, all patients will be instructed on how to evaluate their own pain by using a 10-cm visual analog pain scale (0= no pain, 10= maximum pain imaginable).

The nerve block will be performed in the preoperative block area following standardized monitoring, including noninvasive blood pressure (BP), electrocardiogram (ECG), and pulse oximetry (PO). Oxygen 23 L/min was applied through the nasal cannula, and midazolam 0.025 mg/kg iv, will be given.

All blocks will be performed by the same two experienced senior attending doctors in ultrasound-guided nerve blocks. Patients will be randomly assigned into one of the following groups using computer generated codes and closed opaque sealed envelopes and patient and anesthesiologist who collect data will not know which type of block administered (as block will be done in holding area):

Group 1 (TPVB group): patients will receive TPVB. Group 2 (ESPB group): patients will receive ESPB block. The patient will be placed in the lateral position. Both blocks will be performed under complete aseptic precautions using ultrasound machine with high frequency linear probe covered with sterile sheath .

The blocks will be performed unilateral at the T5-T6 level of the spine using an in-plane approach.

Pre-operative chest ultrasound will be done by the anesthesiologist to detect complications after the blockade (hematoma in the puncture site by direct visualization and pneumothorax by Barcode/Stratosphere sign).

Eligibility Criteria:
Inclusion Criteria:

* Age eligible \>20 - \<70 yrs.
* Sex eligible both sex.
* Patients with American Society of Anesthesiologists (ASA) physical status 13 who will be scheduled for VATS, with three trochar ports. The trochar ports will be made at the fifth and sixth to intercostal levels. The chest drain will be inserted before the skin closure at the seventh or eighth intercostal level.

Exclusion Criteria:

* ≤20 or ≥70 years old.
* Declining to give written informed consent.
* History of allergy to the medications used in the study.
* Contraindication to regional anesthesia (including coagulopathy (platelet count ≤ 80,000, INR ≥ 1.5) and local infection).
* hepatic impairment (INR ≥1.5, Bilirubin ≥2, Albumin ≤2).
* Renal dysfunction (GFR \<50ml/min).
* Psychiatric disorder.
* Pregnancy.
* Body mass index (BMI) ≥40 or ≤18 kg/m2.
* VATS procedure converted to open.
* Patient with history of thoracic spine surgery.
iPeer2Peer Pediatric Thoracic Transplantation

With the on-going presence of a chronic illness, daily immunosuppressive medications, and the need for continuous medical supervision, pediatric transplant recipients face considerable psychosocial stresses. Treatment nonadherence is a major issue in pediatric transplantation and can lead to increased rates of hospitalization, rejection episodes, graft loss and death. An online peer support mentorship program (iPeer2Peer) is proposed as one intervention that could enhance patient care management, increase treatment adherence, reduce social isolation and improve health outcomes for this highly vulnerable population. The proposed trial will determine 1) implementation outcomes of the iPeer2Peer intervention in terms of: (a) feasibility and adoption, (b) acceptability and appropriateness and (c) level of engagement with the program, and 2) effectiveness of the iPeer2Peer intervention on improving health outcomes including disease self-management skills, treatment adherence, quality of life, perceived social support, stress and coping.


Eligibility Criteria:
Inclusion Criteria:

1. heart and/or lung transplant recipient,
2. at least 4 months post-transplant,
3. between the ages of 12 and 25 years,
4. able to speak and read English,
5. willingness to commit to 5-10 texts and/or calls of 20-30 minutes each over a period of 15 weeks.

Exclusion Criteria:

1. have a significant cognitive impairments as assessed by a qualified healthcare provider,
2. have a diagnosis of an active psychological disorder (e.g., Major Depressive Disorder, Generalized Anxiety Disorder) likely to influence assessment of health-related quality of life and/or interfere with their ability to manage their transplant regimen (a diagnosis of an active psychological disorder will be determined for mentees through medical chart review and self-reported by mentors), and
3. are participating in other peer support or self-management interventions
4D-flow Cardiac MRI to Assess Pulmonary Arterial Pressure in Pulmonary Hypertension

Due to radiation exposure and low but real risk of morbidity and mortality associated with right heart catheterization, non-invasive procedures to estimate mPAP are desired for the diagnosis of PH or to monitor treatment effectiveness. Echocardiography is used as a screening tool to estimate systolic pulmonary arterial pressure (sPAP), but due various limitations, this technique is not considered to be sufficiently accurate for the diagnosis of PH. The aim of 4D flow MRI is to evaluate the complete time-varying tridirectional velocity field in a volume of interest. It enables flow and velocity measurements in a vascular region of interest and visualization of vector plots of blood flow velocity fields. Previous studies have shown on the one hand, correlations between mPAP and hemodynamic parameters obtained by phase contrast MRI and, on the other hand, appearance of a vortical blood flow in the pulmonary artery in PH. More studies are required to confirm 4D MRI as a valuable tool for mPAP estimation in PH.

Following screening echocardiography, all patients will undergo right heart catheterization for PH assessment. Then, all patients will be referred for a complete cardiac MRI exam with the addition of a 4D Flow sequence (does not require supplementary injection of a contrast agent and does not extend the duration of the examination) followed promptly (within the same hour) by a Doppler-echocardiography. The data from each examination will be blindly interpreted from the results of the other one. No follow-up will be required for the study.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old,
* Patient referred for cardiac MRI who previously underwent right heart catheterization for pulmonary hypertension assessment,
* Affiliation to a social security program,
* Ability of the subject to understand and express opposition

Exclusion Criteria:

* Age \<18 years old,
* Major obesity (\> 140 kg) not allowing the patient to enter the tunnel of the machine whose diameter is less than 70 cm,
* Person under guardianship or curators,
* Pregnant woman,
* Allergy to gadolinium chelates,
* Claustrophobia,
* Any contraindications to MRI
Efficacy and Safety of Meteospasmyl® in Irritable Bowel Syndrome

To assess the effectiveness of alverine citrate and simeticone on IBS symptoms according to the latest recommended design


Eligibility Criteria:
Inclusion Criteria:

* male or female ambulatory patients, aged 18-75 years
* with IBS as defined by Rome III criteria

Exclusion Criteria:

* Functional bowel disorder other than IBS,
* Underlying cause for symptomatology, which excludes IBS diagnosis,
* Gastro-intestinal cancer or significant gastro-intestinal surgical background,
* Any acute/uncontrolled systemic pathology
A Study to Evaluate Pharmacokinetics, Safety and Tolerability of MEDI0382 in Renal Impairment Subjects

A phase 1 open-label, single-dose study to evaluate the pharmacokinetics (PK), safety, tolerability and immunogenicity of MEDI0382 in subjects with renal impairment.

This is an open-label, single-dose, parallel group study to evaluate the PK, safety, tolerability, and immunogenicity of MEDI0382 in subjects with renal impairment. Enrollment of approximately 40 subjects across multiple sites is planned. Subjects will be divided into 4 groups based on renal function.

Eligibility Criteria:
Inclusion Criteria:

* Must provide written informed consent
* BMI greater than or equal to 17 and less than or equal to 40 kg/m2
* Creatinine clearance rate greater than or equal to 90 (healthy); or renally impaired (less than 60 mL/min)
* Females of childbearing potential must use a highly effective form of contraception.

Exclusion Criteria:

* Any history of or concurrent condition that in the opinion of the investigator would compromise the subjects safety.
* Subjects on dialysis
* Subjects with pancreatitis
* Renal transplant subjects
* Females pregnant or lactating
Esophagectomy for Patients With Esophageal Cancer and Cervical Lymph Node Metastases

There is no world-wide consensus on the oncological benefit versus increased morbidity associated with three field lymphadenectomy in patients with esophageal cancer and cervical lymph node metastases. In Asian countries, esophagectomy is commonly combined with a three field lymphadenectomy, including resection of cervical, thoracic and abdominal lymph nodes. However, in Western countries patients with cervical lymph node metastases are generally precluded from curative treatment.

Objective: To assess the safety and feasibility of curative esophagectomy combined with three field lymphadenectomy after chemo-radiation in Western patients with resectable thoracic esophageal carcinoma and cervical lymph node metastases. Secondary objective is to determine the effect on survival and recurrence.

Study design: Mono centre prospective phase II single-arm feasibility study. Study population: Western patients diagnosed with resectable (cT1-4a, N1-3) intra thoracic esophageal carcinoma with histological or cytological proven cervical lymph node metastases in level III and/ or IV.

Intervention: Transthoracic esophageal resection combined with three field lymphadenectomy after neoadjuvant chemo-radiation.

Main study parameters/ endpoints: Primary outcome is the percentage of overall surgical complications grade 3b and higher as stated by the Modified Clavien-Dindo classification. Secondary outcomes are mortality, operation related events and postoperative recovery, including quality of life, disease free survival, overall survival and if applicable the location of recurrent disease.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven squamous cell carcinoma or adenocarcinoma of the esophagus.
* Surgical resectable carcinoma (T1-4a, N1-3) (table 1)
* Histologically/ cytologically proven resectable cervical lymph node metastases level III and/ or IV
* Age ≥ 18
* European Clinical Oncology Group (ECOG) performance status 0,1 or 2
* Written informed consent

Exclusion Criteria:

* Distant metastases
* Esophageal carcinoma \< 3 cm beneath UES
* Carcinoma of the gastro-esophageal junction (GEJ) with major tumor in the gastric cardia (Siewert III)
* Former radiotherapy or chemotherapy for esophageal carcinoma
* Former radiotherapy precluding radiotherapy according the CROSS protocol
* Inadequate pulmonary function disabling transthoracic resection
* \>10% loss of weight in the last six months
* Previous neck dissection
* New York heart association class III/IV and no history of active angina. Patients with a history of significant ventricular arrhythmia requiring medication or congestive heart failure. History of 2nd or 3rd degree heart blocks
Study on the Medical Education Capability of the EyeTeacher Artificial Intelligence Platform

With the rise of generative artificial intelligence and large language models, medical education is undergoing a significant transformation. Numerous studies have highlighted the limitations of traditional educational knowledge acquisition and the potential impact of artificial intelligence on medical education, resident training, and continuing education for clinical practitioners. However, there is a lack of real-world experiments on the effectiveness of AI-integrated education.

Artificial intelligence can provide extensive educational resources and tools that are not limited by geographical location or language, thereby lowering the barrier to accessing high-quality medical education and promoting educational equity. Nevertheless, the performance of AI models trained by different medical institutions or healthcare systems may vary.

To offer a more universal, accessible, high-quality, and interconnected educational journey. We have developed a virtual ophthalmology teacher, which developed based on foundational model and large language models. This model, named EyeTeacher provide comprehensive theoretical knowledge and clinical skills enhancement for untrained medical students. To verify the effectiveness of our EyeTeacher across different national ophthalmology education systems and languages, we plan to implement a randomized controlled trial. This trial will assess the clinical capabilities of all participants and explore the advantages and disadvantages of the system compared to traditional teaching methods.


Eligibility Criteria:
Inclusion Criteria:

* Clinical medical students who have not taken ophthalmology courses
* Age 21-40
* Gender not restricted
* Sign the informed consent form

Exclusion Criteria:

* Refusal of the research protocol.
* Participants unwilling or unable to understand and complete the questionnaire.
Difference in Central Fatigue During Two Ultra-endurance Practices: Running vs. Cycling

The mechanisms contributing to muscle fatigue in extreme long-duration exercise bouts are poorly understood. Ultra-endurance exercise is an excellent model for the study of adaptive responses to extreme loads and stress and it is an especially useful model for documenting the origins of central fatigue. This protocol will compare fatigue during and after ultra-endurance exercise bouts that result in moderate lower-limb tissue damage (i.e. cycling) or significant damage (i.e. running). The results of this protocol will allow us to further understanding of the reasons for major central fatigue, i.e. within the central nervous system, in ultra-endurance.


Eligibility Criteria:
Inclusion Criteria:

* Specialist in endurance and ultra-endurance. in the 2 disciplines: running and cycling (triathletes, duathletes or trailers achieving at least 30% of their training volume in cycling), and having at least finished one long distance event in the last 2 years,
* Affiliated or beneficiary of a social security scheme.
* Signature of the consent form

Exclusion Criteria:

* Any subject who has been injured in the 3 months prior to the protocol
* Anyone with chronic joint pathologies (e.g.: repetitive sprains, patellar or ligament problems).
* Any subject with chronic or central neurological pathologies
* Any subject with a contraindication to magnetic stimulation
* Use of neuro-active substances likely to alter cortico-spinal excitability (hypnotics, antiepileptics, psychotropic drugs, muscle relaxants) on the study.
* Contraindication to the application of a magnetic field:

  * Heart or respiratory insufficiency.
  * Subject with a cardiac pace maker.
  * Cardiac valve wear and serious cardiovascular diseases.
  * Presence of prosthetic material or ferromagnetic foreign bodies in the head.
  * Presence of cochlear implants or ocular prosthetic material.
  * History of neurosurgical interventions.
  * Neurological diseases that may affect brain structures and cognitive abilities (e.g., intracranial tumour, multiple sclerosis, history of stroke or traumatic brain injury).
  * History of comitiality, contralateral knee disease or musculoskeletal disease.
* Any subject participating at the same time in another interventional experiment requiring physical exercise.
* Any subject who has taken corticosteroids within 3 months (inhalation, infiltration or history of prolonged corticosteroid therapy).
* Any subject under guardianship or curatorship