cyrilzakka/clinical-trials huggingface dataset:
The Effects of SGLTi on Diabetic Cardiomyopathy

Diabetic cardiomyopathy is associated with significant morbidity and mortality. It is considered as a cardiac muscle disorder secondary to diabetes mellitus (DM). Certain studies show the clinical benefit of SGLT-s inhibitors on reducing cardiovascular outcomes amongst patients with type II DM that go beyond the correction of hyperglycemic perse. Thus an observational imaging study is proposed to identify mechanistic insights of the drug group over cardiovascular events.

Diabetic cardiomyopathy is defined as ventricular dysfunction in diabetic patients in the absence of coronary artery disease and hypertension. It is considered as a cardiac muscle disorder due to the metabolic consequences of DM characterized by left ventricular hypertrophy, left ventricular diastolic dysfunction (in the early stage), and/or systolic dysfunction. To date, there is no specific treatment proven effective for the condition due to the incomplete understanding of the pathogenesis.

Recent studies however prove the efficacy of SGLT-2 inhibitors on reducing the primary composite end point of cardiovascular outcomes including hospitalization for heart failure, cardiovascular death, and all-cause death amongst patients with type II DM. Such clinical benefit is apparently mainly stemmed from the reduction in heart failure related mortality and sudden cardiac death rather than the macro-vascular events such as myocardial infarct and stroke, suggesting addition benefits going beyond the correction of hyperglycemia perse. These studies thus raise the possibility that the drug may have direct effects on the myocardium that conferring the clinical benefit not related the modification of traditional risk factors such as glycemic control, lipid, blood pressure, and obesity.

A single-arm, observational cardiac magnetic resonance imaging study is proposed in type II diabetic patients before and 2 months after initiation of dapagliflozin. The aim is to identify mechanistic insights leading to the unexpected clinical benefit of SGLT inhibition.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* 40-90 years old
* HbA1c \>= 6.5%
* history of heart failure with reduced ejection fraction
* indications for SGLT inhibition on clinical ground

Exclusion Criteria:

* angina pectoris or chest discomfort
* prior coronary artery bypass grafts
* coronary artery stenting within 6 months of study enrolment
* pervious myocardial infarct
* any contraindication for stress CMR testing
* renal impairment with eGFR \<45ml/min/1.73m2
* limited life expectancy \<5 years, for example due to pulmonary disease, cancer or
* significant hepatic failure
* contraindication to dapagliflozin or other SGLT2 inhibitors
* unable to take dapagliflozin
* patients currently on and SGLT2 inhibitor
* planned need for concomitant cardiac surgery or coronary intervention
* refusal or inability to sign an informed consent
* potential for on-compliance towards the requirements in the trial protocol (especially the medical treatment) or follow-up visits
Helicobacter Pylori Empiric Treatment in Ulcer Bleeding

The goal of the study is to compare the effectiveness of empirical Helicobacter pylori treatment compared with treatment depending on diagnostic tests for Helicobacter pylori in patients with Upper gastrointestinal bleeding due to peptic ulcer. Main hypothesis is that empirical treatment will reduce the number of patients lost to follow-up thus improving the cure rates of Hp infection.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18.
* Informed Consent signed.
* Diagnosis of no variceal upper gastrointestinal bleeding secondary to a duodenal ulcer, erosive duodenitis or gastric ulcer.
* Life expectancy longer than 6 months.
* Able to attend further clinical controls.
* Absence of the following exclusion criteria.

Exclusion Criteria:

* Previous eradication treatment.
* Use of antibiotics 2 weeks prior to inclusion.
* Need for Antisecretor treatment that cannot be stopped to perform the breath test.
* Pregnancy or breastfeeding.
Efficacy of Intravenous In-line Filter in Patient Undergoing Cardiac Surgery

The aim of this study is to demonstrated efficacy of in-line filtration to reduce systemic inflammatory response syndrome (SIRS) ,specific organ dysfunction and complications in adult cardiac surgery. 486 patients undergoing cardiac surgery for acquired heart disease are 1:1 randomized into in-line filtration (study group) and non-filtration (control group). The incidence of SIRS, complications, daily SOFA (sequential organ failure assessment) score are compared between groups.

This clinical trial is performed at Ramathibodi hospital, Mahidol university in Bangkok, Thailand. The protocol has been approved by institutional ethical committee (ref. ID 11-60-64) with informed consent required for all patients.

The incidences of SIRS between the control and the filter group in pediatrics population from previous study were 35% and 25.2% respectively (risk difference -11.3%, 95% CI -21.8 to -0.5%). The author estimated the sample size of 486 randomized patients to give 80% power at the 10% significant level (alpha 0.1, beta 0.8).

Patients aged 18 years or older undergoing elective cardiac surgery for acquired heart disease (including isolated coronary artery bypass grafting (CABG), isolated valve surgery, combined valve surgery, or concomitant CABG and valve surgery) are randomized 1:1 into in-line filtration (study group) and non-filtration (control group).

For patients randomized to in-line filtration, in-line filters (Pall, Dreieich, Germany) are used for all intravenous access during operation and postoperative period in intensive care unit (ICU).

For patients randomized to control group, All intravenous access is managed routinely according to local standard care without filtration during operation and postoperative period in ICU.

Primary endpoint of this study is the incidence of SIRS after cardiac surgery. SIRS is diagnosed when patients have two or more of these criteria: 1.Heart rate \>90/min, 2.Temperature \>38 °C or \<36 °C, 3.Respiratory rate \>20/min or Paco2 \<32 mm Hg (4.3 kPa), and 4.White blood cell count \>12000/mm3 or \<4000/mm3 or \>10% immature band.

Secondary endpoints are complications as defined by Society of Thoracic Surgeons (STS) Adult Cardiac Surgical Database, daily SOFA score and organ dysfunction as defined by The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).

Continuous data were reported as mean (standard deviation, SD) or median (interquartile range, IQR) and compared by independent sample t-test or the Mann-Whitney U test. Categorical variables were presented as frequency (%) and analyzed by chi-squared or Fisher's exact test. Statistical significance was defined as a P-value \< 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 18 years or older undergoing elective adult cardiac surgery

Exclusion Criteria:

* Emergency surgery
* Patient who does not want to participate in the study
Comparison Study of Electrocardiogram Indexes in Patients With Epilepsy, Patients With First Seizure and Normal Population

According to recent advances in epileptic heart and sudden unexplained death in epilepsy, in this study the investigators aimed to compare ECG findings in patients with epilepsy, patients who had experienced their first seizure and patients without history of seizure.


Eligibility Criteria:
Inclusion Criteria for group 1:

* History of epilepsy for at least 2 years
* Taking antiseizure medications

Inclusion Criteria for group 2:

- Solid history of first seizure confirmed by a neurologist

Inclusion Criteria for group 3:

- No history of seizure

Exclusion Criteria:

* History of known cardiac disease or medical condition precipitating cardiac disease
* Electrolyte imbalance Taking medications with significant effect on ECG indexes
Real World Data Analysis: Impact of High-Frequency REN Treatments As Migraine Preventive Therapy in Adolescence

This is a post-marketing study investigating the safety and efficacy of the REN device (Nerivio by Theranica, ISRAEL) in adolescents with migraine. The data analysis will test the ability of Frequent use of REN for the acute treatment of migraine to reduce the number of monthly migraine days in subsequent months, suggesting potential preventive benefits.

The REN device (Nerivio by Theranica, ISRAEL) is a neuromodulation device approved by the FDA for acute and/or preventive treatment of migraine in patients of 12 years old and above. It is a wearable device applied to the upper arm. It stimulates C and Aδ noxious fibers using a modulated, symmetrical, biphasic, square pulse with a pulse width of 400 μs, modulated frequency of 100-120 Hz, and up to 40 mA output current which the patient can adjust. The REN device is operated by a designated app that is downloaded to the user's phone prior first use of the Nerivio device.

As part of the sign-up process to the Nerivio app, all patients accept the terms of use which specify that providing personal information is done by their own free will and that their de-identified data may be used for research purposes. Users are not obligated to provide personal information and could treat without providing any feedback. The app includes a secured, personal migraine diary, which enables patients to record and track their migraines and other headaches. At the beginning of each treatment, and again 2 hours after the start of treatment, patients are prompted to record their symptoms, including pain level (none, mild, moderate, severe), functional disability (No limitation, Some limitation, Moderate limitation, Severe limitation), and an indication of which medications, if any, were taken within that 2-hour time window.

This post-marketing RWE study investigates the potential of high usage of Nerivio for the acute treatment of migraine on migraine prevention, using the following outcomes:

1. - reduction in mean monthly migraine treatment days (MMTD),
2. - acute treatment efficacy measured 2 h post-treatment
3. - improve in functional disability
4. - Device safety

Together, these objectives may provide a comprehensive evaluation of the impact of the high usage of Nerivio for acute treatment as a migraine preventive tool in the migraine adolescent population.

Eligibility Criteria:
Inclusion Criteria:

* patient age is 12 Years to 18 Years
* Patient is using the Nerivio device for acute treatment of migraine
* Patient treated at least 10 treatments in his first month of using Nerivio and at least 3 treatments in each of the two consecutive months (months 2 and 3

Exclusion Criteria:

* Treatments shorter than 30 minutes
Effects of a 60-min Repeated Trunk Flexion Protocol on Trunk Neuromuscular Properties.

An interventional study on the effects of repeated trunk flexion exposure on trunk neuromuscular properties.

An interventional study will include 16 healthy young adults. All participants will complete a 60-min protocol of intermittent trunk flexion. Measurements of trunk neuromuscular properties will be performed prior to and following the 60-min protocol.

Eligibility Criteria:
Inclusion Criteria:

* Physically active at least 3 hours a week

Exclusion Criteria:

* Low back pain in the past 6 months
* History of chronic low back pain
* History of spinal or pelvic operation
* Hypermobility, more than 4 points on Beighton scale
* Cardiovascular or systemic diseases
* Pregnancy
Pilot Study for Thyroid Surgery by Preoperative Video Support and Personalized and Secure Web Platform

The medical information delivered to the patient before any surgery constitutes an essential and compulsory step during the initial management of the operated patient.

There are different reasons for the quantity and quality of medical information retained by the patient. An internet platform with personalized and secure access has been developed. This platform contains, among other things, an explanatory video of thyroid surgery and allows the patient to have access to information on surgical management at any time.

The investigators believe that unlimited access for the duration of the study to this platform could reduce the preoperative anxiety level of patients.

The objective is to assess the impact of additional, personalized and accessible preoperative medical information via a secure internet platform on the anxiety level of patients before their surgery. For this, patients agreeing to participate in the study will be randomized (drawn at random) during the inclusion visit and divided into one of the following two groups:

* The control group: patients included in this group will receive the usual medical information as part of the surgery performed;
* The experimental group: the patients included in this group will have, in addition to the usual medical information, personalized and secure access to a platform so that they can have additional information on the surgery performed.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75,
* Indication of lobo-isthmectomy or total thyroidectomy
* Compliance for the completion of self-questionnaires
* Person affiliated or beneficiary of a social security scheme.
* Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).

Exclusion Criteria:

* Difficulty understanding the French language
* Lack of internet access
* Persons placed under the protection of justice,
* Person under guardianship or curatorship
* Person participating in another research including an exclusion period still in progress,
* Subject with severely impaired physical and / or psychological health, which, according to the investigator, may affect the compliance of the study participant
* Pregnant / lactating woman
Outcomes of Early Versus Delayed Oral Feeding After Cesarean Section in Korle-bu Teaching Hospital

study compares the outcomes of feeding mothers early (4 hours ) after cesarean section compared to delayed feeding (on post operation day 1) in terms of gastrointestinal function and maternal satisfaction with the feeding schedule.

patients who are scheduled to undergo elective cesarean section are randomised to two groups, one group will be allowed to feed 4 hours after cesarean section while the other group will be fed traditionally by feeding on the first post op day. gastrointestinal signs and symptoms will be measured such as post operative ileus, vomiting, nausea, abdminal distension. other parameters to be measured include time to ambulate out of bed after surgery, time to start breastfeeding after surgery. satisfaction with both feeding regimes will be assessed after surgery and the incedence of wound infecion will be compared between the two groups after two weeks durung the post natal review.

Eligibility Criteria:
Inclusion Criteria:

Uncomplicated elective Cesarean sections performed under regional anaesthesia without extensive intra operative bowel adhesions.

Women who give consent to participate in the study.

Exclusion Criteria:

* Elective Cesarean sections complicated by severe haemorrhage, bowel injury requiring bowel manipulation, repair, resection and anastomosis or colostomy.

Women who require a Cesarean hysterectomy. Women who require a Post-partum hysterectomy. Mothers with severe pre-eclampsia. Mothers with sickle cell disease. Mothers with pregestational or gestational diabetes. Mothers who have been scheduled for Cesarean section and require general anaesthesia.

Women who have had a previous laparotomy other than a Cesarean section.
Effects of Electrotherapy on Pain, Anxiety, Motion and Disability in Adults With Neck or Upper Body Pain.

This will be a prospective randomized controlled trial with sixty adults, 20 to 40 years of age. There will be three groups as follows: the normal group, control group, and intervention group where subjects will receive instructions for home use of TENS for pain reduction. The aim is for an equal distribution of males and females in each group.

This will be a prospective randomized controlled trial with sixty adults, 20 to 40 years of age. There will be three groups as follows: twenty subjects with no pain in the normal group; forty subjects with chronic subclinical neck or upper quadrant pain will be randomized into two groups: twenty subjects in the control group, and twenty subjects in the intervention group. The aim is for an equal distribution of males and females in each group.

Data will be collected for each subject using the NORAXON® myoMOTION™ System, the visual analog scale (VAS), the State-Trait Anxiety Inventory (STAI), and the Neck Disability Index (NDI); all assessments will be made by a clinician.

Normal group (20 subjects): Initial assessment on day one and post assessments on day eight and on day thirty. Control group (20 subjects): Initial assessment on day one and post assessments on day eight and on day thirty. Intervention group (20 subjects): Initial assessment on day one pre-intervention and post-intervention assessment of high-frequency sensory TENS (gate control theory of pain) for thirty minutes followed by post-assessments in day eight and day thirty.

The intervention group will receive a thirty-minute high frequency TENS (gate control theory of pain) once a day for seven days and twenty-one days after the initial seven days to measure immediate and short-term effects on the dependent variables further described below. Subjects will be educated on TENS usage by a licensed physical therapist. A daily log will be given to all subjects in the intervention group to assure compliance with treatment. In addition, the TENS device will keep track of date, time and day of usage, and TENS parameters.

Eligibility Criteria:
Inclusion Criteria for Subjects without Pain Group:

* \> 19 and \<41 years of age
* Currently enrolled as students at Loma Linda University.
* No pain

Exclusion Criteria for Control Group:

* Neck and/or upper quadrant pain
* \<20 years or \>40 years of age

Inclusion Criteria for Subjects with Pain Groups:

* \>19 and \<41 years of age
* Currently enrolled as students at Loma Linda University
* No acute pain
* With neck and/or upper quadrant chronic pain
* With \<5/10 pain on the Visual Analog Scale (VAS)

Exclusion Criteria for Subjects with Pain Groups:

* \<20 years or \>40 years of age
* Acute pain
* With \>5/10 pain on the Visual Analog Scale (VAS)
* Currently receiving clinical pain treatment
* Pain medications within six hours of data collection
* Contraindications for the use of electrotherapy
MRI Perfusion on T1 and T2 Brain Lesion(s)

This study therefore aims to assess current treatment recommended by scientific societies \[ 6-13 \] , brain MRI with injection of contrast for the diagnosis and monitoring of brain metastases . The recommended dose of this examination gadolinium is from 0.1 to 0.3 mmol / kg \[ 14 \] . Sequences infusion different from one center to the other made : some use the infusion T1, other infusion T2 \* . No recommendation establishes whether it is preferable to use one or the other of these sequences.

No examination is added for the purposes of protocol. Indications for MRI and the number and timing of MRI checks under this protocol are consistent with what is done in practice . The used type of gadolinium and the injected dose will be identical for both sequences infusion . The assessment shall not in any case the contrast but the interpretation of the sequence itself. Special procedures monitoring implemented embodiment correspond to the two sequences instead of infusion (one of T1-weighted and T2 \* in the other ) , in the original MRI and MRI of the first control , in order to compare their effectiveness

Eligibility criteria:

* Major Patients
* Addressed MRI for initial assessment of brain metastases
* At a suspicion of one or more brain metastases in the brain scanner routine screening
* Follow for lung cancer histologically documented
* In the Thoracic Oncology Service Professor Lafitte (contact: Dr Cortot)
* To whom treatment with chemotherapy or targeted therapy (including anti-angiogenic) is considered
* Be socially insured

Main Outcomes measures:

Comparing the area under the ROC curve of different parameters evaluated in T1 and T2 \* perfusion during the initial assessment for the diagnosis of maximal tumor response evaluated at 1 year

Eligibility Criteria:
Inclusion Criteria:

* Major Patients
* Addressed to MRI for initial assessment of brain metastases
* At a suspicion of one or more brain metastases in the brain scanner routine screening
* Followed for lung cancer histologically documented in the Thoracic Oncology Service of Professor Lafitte (contact: Dr Cortot)
* To whom treatment with chemotherapy or targeted therapy (including anti-angiogenic) is considered
* Be socially insured-

Exclusion Criteria:

* Absolute contraindication to MRI (pacemaker, implantable pacemaker, metallic foreign body intraorbital)
* Patients minors under guardianship / curatorship
* Patients with impaired judgment skills or unable to receive information
* Pregnant Women
* Patients for which lesions are not compatible with lung metastases
* Patients with brain metastases or already known and explored MRI
* Patients for whom treatment by surgical excision of brain metastases is considered
A Phase I Study to Determine the Effect of Food on Brivanib (BMS-582664)

The purpose of this trial is to determine the effect of food versus a fasted state on single-dose pharmacokinetics of BMS-540215, the active metabolite of Brivanib alaninate


Eligibility Criteria:
For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:

* Histologic/cytologic diagnosis of advanced or metastatic solid tumors
* ECOG 0-2
* 4/6 weeks since prior therapy

Exclusion Criteria:

* Brain metastases
* Second primary malignancy
* Thromboembolic disease requiring full anticoagulation within 6 months
* Inability to swallow or absorb oral therapy