cyrilzakka/clinical-trials huggingface dataset:
Intravenous Exenatide in Coronary Intensive Care Unit (ICU) Patients

The purpose of this study is to determine the efficacy of intravenous Exenatide therapy in hyperglycemic patients admitted to the coronary intensive care unit.

Diabetic patients with acute myocardial infarction (MI) have particularly poor outcomes. Clinical practice guidelines from the American College of Cardiology/American Heart Association for the treatment of patients with acute coronary syndromes call for treatment to achieve preprandial glucose \<110 mg/dL, a maximum daily target \<180 mg/dL, and a post-discharge hemoglobin A1c \<7%. Initiation of aggressive insulin therapy is also warranted to achieve blood glucose \<150 mg/dL during days 0-3 and 80-110 mg/dL when possible thereafter. To date, no studies have been conducted assessing the efficacy of intravenous exenatide administration on achieving glucose lowering in hyperglycemic coronary ICU patients.

Eligibility Criteria:
Inclusion Criteria:

* Admission to coronary ICU
* Admission blood glucose 140-299 mg/dL
* Primary cardiovascular diagnosis by attending physician
* Under primary care of cardiology service
* Age \> 18 years old
* Ventilator independent
* Able to provide informed consent

Exclusion Criteria:

* Admission blood glucose \< 140 or \> 300 mg/dL
* Ventilator dependent
* Unconscious sedation
* Type 1 diabetes
* Known pregnancy
* Admitted to coronary ICU for right heart cath to measure hemodynamics prior to transplant
* Post transplant procedure
* Currently enrolled in another clinical trial
* Unable to provide informed consent
* Creatinine clearance \< 30 mL/min
* On insulin treatment except for monotherapy with long-acting basal insulin (e.g., insulin glargine \[Lantus®\] or detemir \[Levemir®\])
* Gastroparesis
Taurine in Peripartum Cardiomyopathy

Taurine as an adjunct for early left ventricular recovery in peripartum cardiomyopathy


Eligibility Criteria:
Inclusion Criteria:

* Peripartum Cardiomyopathy

Exclusion Criteria:

* Other identifiable cause for heart failure
* low LVEF ≤ 25%
* sepsis
* autoimmune disease
* severe chronic disease
* malignancy
Training Dual-Task Walking After Stroke

Community ambulation is a highly complex skill requiring the ability to adapt to increased environmental complexity and perform multiple tasks simultaneously. Deficits in dual-tasking may severely compromise the ability to participate fully in community living. Unfortunately, current rehabilitation practice for stroke fails to adequately address dual-task limitations; individuals with stroke continue to exhibit clinically significant dual-task costs on gait at discharge. As a result, many stroke survivors are living in the community with residual deficits that may increase disability in the real world and lead to falls with devastating consequences. To address this issue, the proposed study investigates the efficacy of dual-task gait training on attention allocation and locomotor performance in community-dwelling stroke survivors. Because walking in the real world often requires time-critical tasks and obstacle avoidance, the investigators will test the impact of dual-task gait training on cognitive-motor interference during walking at preferred speed and at maximal speed (Aim 1), and on locomotor control during obstacle negotiation (Aim 2). The investigators will also evaluate the effects of the intervention on community reintegration and participation (Aim 3).


Eligibility Criteria:
Inclusion Criteria:

* Within 3 years of stroke onset
* Living in the community, operationally defined as living in one's own home, or the home of a friend, relative, or caregiver
* Walking speed 0.6-1.1 m/s determined during 10-meter walk test
* Walk without the assistance of another person
* Medically stable and approved for participation by study physician
* Intact global cognition indicated by score \> 23 on Montreal Cognitive Assessment
* Living in the community prior to stroke

Exclusion Criteria:

* Pre-existing neurological disorders (e.g., Parkinson's disease, Multiple Sclerosis, dementia, traumatic brain injury)
* Previous stroke with residual motor deficit
* Uncontrolled hypertension
* Inability to follow 3-step command
* Primary uncontrolled hearing impairment
* Severe uncontrolled visual impairment
* Any speech-language impairment affecting ability to respond verbally to auditory stimuli
* Timed Up and Go test \> 15 seconds
* Lower extremity amputation
* Any orthopedic problem affecting gait
* Concurrent participation in another clinical trial
Sarcosine or D-Serine Add-on Treatment for Chronic Schizophrenia

Both GlyT-1 inhibitors and NMDA-glycine site agonists have been demonstrated to be beneficial for chronic schizophrenia patients.

The purpose of this study is to compare efficacy and safety of add-on treatment of sarcosine, a GlyT-1 inhibitor, and D-serine, an NMDA-glycine site agonist, in chronically stable schizophrenia patients who have been stabilized with antipsychotics.

The etiology of schizophrenia remains unclear. Schizophrenia patients reveal positive symptoms, negative symptoms, and cognitive impairments. In addition to dopamine system hyperactivity, hypofunction of N-methyl-D-aspartate (NMDA) receptor plays a role in the pathophysiology of schizophrenia. Consequently, enhancing NMDA receptor neurotransmission has been regarded as a novel treatment approach. To date, there have been several reported trials on NMDA enhancers. Both sarcosine (N-methylglycine, a glycine transporter I inhibitor) and D-serine (a potent NMDA-glycine site agonist) showed therapeutic effects in chronically stable patients. Interestingly, sarcosine appeared more efficacious than D-serine in acutely exacerbated ones when added-on to antipsychotics. Both sarcosine and D-serine yielded excellent safety profiles.

It remains unclear whether sarcosine can be also more efficacious than D-serine in the treatment for chronically stable schizophrenia. The aim of this project is to examine the efficacy and safety of add-on treatment of sarcosine vs. D-serine in chronically stable schizophrenia patients who have been stabilized with antipsychotics.

In the study, 60-75 schizophrenic patients are recruited into the 6-week trial and randomly assigned into the three groups (2 gm/d sarcosine, 2 gm/d D-serine, or placebo) with a double-blind manner. Clinical manifestation (Positive and Negative Syndrome Scale \[PANSS\], side effects and quality of life (QOL) are evaluated every two weeks during the trial.. The efficacies of three groups are compared.

Eligibility Criteria:
Inclusion Criteria:

* Fulfill the criteria of schizophrenia according to the Diagnostic and Statistic Manual, fourth edition (DSM-IV).
* Agree to participate in the study and provide informed consent.

Exclusion Criteria:

* Meet DSM-IV criteria of major mood disorder, current substance dependence or mental retardation
* History of epilepsy, head trauma or CNS diseases
* Major, untreated medical diseases
* Pregnancy or lactation
A Phase II Study to Assess Changes in Physical Function in Elderly Patients With Chronic Anemia

The purpose of this study is to assess changes in physical function in elderly patients (\>= 65 years of age) with chronic anemia (Hb \<= 11.0 g/dL) due to anemia of unknown cause and receiving weekly subcutaneous doses of Epoetin alfa (PROCRITÂ®) versus placebo.

.Some elderly patients have anemia (reduction in hemoglobin level, or low red cell count) without obvious cause. Anemia occurs commonly with aging and is a frequent medical condition in individuals over the age of 65. Physical performance and function is worse in individuals who are anemic. This is a randomized, double-blind, placebo-controlled, multi-center study to assess physical function (to include falls) and fatigue in approximately 80 elderly patients with chronic anemia (anemia present for at least 3 months) and who are receiving weekly Epoetin alfa. The study will also evaluate hemoglobin levels (oxygen carrying protein in red blood cells), safety, fatigue and cognitive function. The study hypothesis is to demonstrate the study drug will be more effective in treatment of chronic anemia than placebo, resulting in the improvement of physical function and subsequent disabilities, with minimal adverse events and the study drug is generally well-tolerated. The patients will receive weekly injections of Epoetin alfa (PROCRIT®) or placebo at a starting dose of 10,000 units administered subcutaneously (under the skin).

Eligibility Criteria:
Inclusion Criteria:

* Patients with a history of chronic anemia defined as a documented Hb value of \<= 11.0 g/dL
* No active cancer
* At least 65 years of age with life expectancy of \> 6 months
* Community dwelling patients
* Patients with a Short Physical Performance (SPPB) Summary Score of 4-10 at screening and baseline
* Patients with a Mini Mental State Examination (MMSE) score \>= 24

Exclusion Criteria:

* Positive stool guaiac test
* Diagnosis of multiple myeloma and/or MGUS
* History of venous thromboembolytic disease
* Previous treatment with Epoetin alfa, Darbepoetin or any form of erythropoietin recently
* Uncontrolled or severe cardiovascular disease
Transcranial Static Magnetic Stimulation (tSMS) and Potential Theranostic Biomarkers in Amyotrophic Lateral Sclerosis.

The objective of the present study is to assess the efficacy of tSMS in ALS patients. This will be achieved by monitoring:

* levels of NF-L and other potential innovative biomarkers,
* clinical progression, trough ALSFRS-R. After at least three-month follow-up, participants will be recruited to undergo biemispheric tSMS for two daily sessions of 120 minutes each, at home, for 12 months. Together with clinical status, which will be evalueted each three months, blood and urine samples will be collected before the start of the tSMS administration (M0) and during the treatment (M3, M6, M9, M12), to detect potential theranostic biomarkers. In a subgroup of patients, ad additional blood and urine sample will be collected 3 months before M0 (M-3).

Moreover, cortical excitability will be tested through transcranial magnetic stimulation (TMS) before and after the tSMS stimulation period.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18
* diagnosis of possible, probable or definite ALS according to revised El Escorial criteria and Awaji-Shima criteria
* disease duration \< 24 months
* ALSFRS-R \> 30 at the recruitment
* ALSFRS-R decline \> 1 in the at least 3-months period before the intervention
* normal respiratory functionality at the preliminary evaluation (M-3), assessed in the previous month (FVC ≥ 75% and ALSFRS-R items 10,11,12 \> 4)
* treatment with riluzole 50 mg x 2/die

Exclusion Criteria:

* inclusion in other clinical trials
* presence of tracheotomy or/and PEG (percutaneous endoscopic gastrostomy)
* unable to perform spirometry due to severe bulbar involvement
* contraindications to magnetic fields exposure
* pregnancy or breastfeeding
* history of epilepsy or seizures
* use of drugs acting on central nervous system, except for antidepressive drugs and benzodiazepines.
* cognitive impairment
* lack of informed consent
Measuring Brain Activity of School Age Children

This observational study will investigate whether differences in birth events and oxygen levels during the newborn period affects the brain activity of children during the middle childhood years.

The investigators will conduct an observational study comparing two groups of children to determine whether differences in birth events and oxygen levels during the newborn period lead to structural and functional impairment within the brain's dopaminergic pathways and the cortical regions innervated by those pathways. The dopaminergic system is involved in modulating motor control and cognitive function.

Using magnetic resonance diffusion tensor imaging, structural integrity of dopaminergic circuits will be quantified and compared in post-hypoxic former preterm children versus healthy control children born at term closely matched by age/sex/race.

Functional activity during executive function tasks will be quantified and compared in post-hypoxic former preterm children versus healthy control children born at term using functional magnetic resonance imaging-blood oxygen level dependent (fMRI-BOLD). Assessment of motor function (grooved pegboard task) will also be performed.

Eligibility Criteria:
Inclusion Criteria:

1. For Study Group Children: Birth gestational age between 23-28 weeks and birth weight appropriate for gestational age (AGA) with available oxygen saturation level data recorded continuously from the first day of life to 8 weeks postnatal age (n=11)
2. For Healthy Control Children: Birth gestational age ≥ 38 weeks gestation and birth weight appropriate for term gestation (n=10) matched by age/sex/race to participating cohort children.
3. Born in years 2005-2009 (age range will be 8-15 years during the funding period)
4. Ability of the child to provide assent, with the parent/legal guardian able to provide written informed consent for study procedures.
5. Sensory and motor capability to complete study tasks (i.e. Grooved Pegboard test). Mental Development index must be \> 80 at 2-year-old follow-up for preterm cohort.

Exclusion Criteria:

1. Past history of concussion requiring medical treatment to avoid confounding of MRI data
2. Current diagnosis of autism.
3. Child who suffers from claustrophobia (per parent report).
4. Unable to participate in neuroimaging due to claustrophobia, or medical contraindication to MRI including any implanted medical device, dental braces, surgical clips for aneurysms in the head, heart valve prostheses, electrodes or other metallic objects, pregnancy.
5. Healthy control children who were treated in the Neonatal ICU in the newborn period for breathing difficulties.
6. Healthy control children who were hospitalized for breathing problems in the first 3 months of infancy.
Efficacy of Hyaluronic-acid and Hydrogen-Peroxide Mouthwash in Gingivitis Treatment

A clinical study to evaluate the efficacy and safety of a mouthwash containing Hydrogen Peroxide, Sodium Hyaluronate and Glycine in the prevention and management of complications associated gingivitis by film forming action.

50 subjects will be enrolled, who show with gingivitis caused by accumulation of plaque and/or tartar selected consecutively. Subsequently, subjects will be equally divided and randomized into the test group or control group.

During the three examinations, the subjects will undergo the collection of bleeding and plaque indices according to Silness J \& Loe H 3,4. Four surfaces per tooth (vestibular, lingual/palatal, mesial, distal) will be considered.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged between 12 and 50 years
* Presence of gingivitis caused by accumulation of plaque/tartar
* Acceptance of informed consent

Exclusion Criteria:

* subjects suffering from HIV
* subjects suffering from hepatitis
* serious systemic diseases preventing the use of specific dental therapies
* acute and/or chronic infectious diseases
* inability to provide consent
* use of topical or systemic drugs
* inability to follow post-intervention hygiene instructions
* smokers
Genomic Signatures for Patients With Initially Unresectable Colorectal Liver Metastases

A retrospective cohort of 286 patients with synchronous CRLM underwent conversion therapies based on next-generation sequencing (NGS) results. All cases were categorized into a successful conversion therapy group (SCTG) if they achieved no evidence of disease (NED) status through surgery after conversion therapy, and a failed conversion therapy group (FCTG) otherwise. Clinical risk factors and genomic mutations were analyzed for association with conversion therapy outcomes and survival.

All procedures involving human participants in this study adhered to ethical standards set by institutional and/or national research committees, as well as the 1964 Helsinki Declaration and its later amendments or similar ethical standards. This cohort study has been reported in line with the STROCSS criteria.

This study enrolled 286 patients initially diagnosed with colorectal cancer (CRC) concomitant with synchronous liver metastases. All patients received comprehensive treatment and follow-up at the Department of Colorectal Surgery, First Affiliated Hospital of Nanjing Medical University between 2016 and 2018. At diagnosis, all patients met the criteria for preoperative conversion therapy, with a Cancer Recurrence Score (CRS) of ≥3. Patients were excluded if they: i) could not tolerate a full course of systemic therapy; ii) had a history of other malignancies; iii) had previously undergone cancer treatment; or iv) Patients who were not rendered disease-free at time of hepatic resection (i.e., primary intact, unresected extrahepatic disease, or gross \[R2\] residual hepatic disease) were excluded. Next-generation sequencing (NGS) was conducted on biopsy tissues obtained via colonoscopy prior to treatment initiation, and conversion therapies were subsequently administered. Systemic treatment regimens, based on NGS results, included FOLFOX/FOLFIRI or FOLFOXIRI combined with anti-EGFR or anti-VEGF agents, excluding those who received Selective Internal Radiation Therapy (SIRT) or Stereotactic Body Radiation Therapy (SBRT). All patients were microsatellite stable (MSS) and did not receive any immune checkpoint therapies such as PD-1 inhibitors. Patients with locally advanced rectal cancer received additional neoadjuvant radiotherapy to the rectal area. Treatment response was assessed every two cycles, and resectability of the primary tumor and metastases were evaluated post-treatment using abdominal contrast-enhanced CT and MRI.

Eligibility Criteria:
Inclusion Criteria:

At diagnosis, all patients met the criteria for preoperative conversion therapy, with a Cancer Recurrence Score (CRS) of ≥3

Exclusion Criteria:

Patients were excluded if they: i) could not tolerate a full course of systemic therapy; ii) had a history of other malignancies; iii) had previously undergone cancer treatment; or iv) Patients who were not rendered disease-free at time of hepatic resection (i.e., primary intact, unresected extrahepatic disease, or gross \[R2\] residual hepatic disease) were excluded.
Surgical Treatment of Lower Eyelid Involutional Entropion and Dermatochalasis

lower eyelid involutional entropion and dermatochalasis are common associated problems. combined approaches give good results.

traditional lower eyelid transcutaneous blepharoplasty ; subciliary incision followed by proper dissection then lower eyelid retractors plication after orbital fat removal . pentagon wedge resection of lateral lower eyelid is done

Eligibility Criteria:
Inclusion Criteria:

1. Lower eyelid involutional entropion
2. dermatochalasis

Exclusion Criteria:

1. Other eyelid disease,
2. Other causes of entropion
3. Previous eyelid surgery
Retrospective Observational Study of Patients With a Sutureless Aortic Valve Implanted in the Cardiovascular and Thoracic Surgery Department of Dijon CHU

The incidence of aortic valve disease is increasing steadily because of the ageing of the population. At a certain stage, replacement of the aortic valve improves symptoms and thus the quality of life of patients.

Surgical aortic valve replacement is the " gold standard ". The procedure involves stopping the heart and setting up cardiopulmonary bypass (CPB) to ensure the oxygenation of tissues.

The reference technique consists in suturing a prosthetic valve to the aortic annulus so as to restore normal function. This technique has very good results in the long term. The elective approach is sternotomy, which has certain drawbacks: post-operative pain, risk of infection, psychological trauma of a major incision. In recent years an alternative approach, right minithoracotomy, has been proposed. The drawback to this approach is that it increases aortic cross-clamp time and CPB time.

More recently, new prosthetic valves, so-called "sutureless" or "rapid deployment" valves have become available. The main advantage of these valves is that they are easy to implant, as they do not require or need just a few sutures. As a result heart-arrest time is shorter, post-operative inflammatory syndrome is less frequent and transfusion needs are reduced.

However, these valves have a metallic stent to fix the valve in place by pressing against the aortic annulus, which may give rise to intra-cardiac conduction disorders. Yet, very few studies have been conducted on this subject.

The investigators wish to evaluate these conduction disorders in a cohort of patients operated on in this Department with this sutureless or rapid deployment valve technique.


Eligibility Criteria:
Inclusion Criteria:

All patients who underwent implantation of a Suturless valve since 2015 (Intuity Elite Edwards or Perceval S Liva Nova)

Exclusion Criteria:

* patients with a pacemaker
* patients who underwent double valve replacement
Prediction of Mortality After CIED Implantation (PM-CIED)

The study aims to develop and validate predictive models for the mortality of patients receiving CIED (including CRT and ICD) implantation.

The study aims to develop and validate predictive models for the mortality of patients receiving cardiovascular implantable electronic devices (CIED) \[including cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillator (ICD)\] implantation, with traditional statistical analysis and machine learning algorithms.

Eligibility Criteria:
Inclusion Criteria:

* all patients who received implantation of CRT/ICD

Exclusion Criteria:

* patients who received generator placement of CRT/ICD