cyrilzakka/clinical-trials huggingface dataset:
Impact of a Technology Platform Based on Enhanced Recovery After(ERAS) Surgery on Length of Stay After Coronary Artery Bypass Grafting: Timely Project

Cardiovascular diseases continue to be the leading cause of death worldwide. Among them, coronary artery disease has the greatest impact, being characterized as one of the main causes of death in Brazil over the last decade. One of the well-established treatments is coronary artery bypass grafting, which is the most performed among cardiac surgeries and, in our scenario, is primarily funded by the Unified Health System (SUS). The information obtained from the Paulista Registry of Cardiovascular Surgeries (REPLICCAR), in partnership with FAPESP, has been important for implementing improvements in the landscape of cardiac surgeries in the state of São Paulo. Although outcomes in cardiac surgery have improved due to the structuring and organization of quality programs, this is still not a reality at the national level. In a situation where data collection and quality initiatives play a central role in continuous improvement, generating value becomes essential for the sustainability of cardiac surgery programs. In this sense, the concept of Enhanced Recovery After Surgery (ERAS) has gained increasing traction. This concept is based on multidisciplinary protocols and scientific evidence, which help prepare patients for rapid recovery, resulting in reduced complications, shorter hospital stays, and, primarily, lower hospital costs. On the other hand, the increase in surgical waiting lists has also led to a rise in home mortality due to cardiac causes. Thus, among the various challenges imposed by the current scenario, the investigators believe that preparing patients for rapid recovery after coronary artery bypass grafting presents an opportunity for the sustainability of the healthcare system. Therefore, the aim of this project is to evaluate the impact of a technology platform based on ERAS on the postoperative recovery time of patients undergoing coronary artery bypass grafting in reference centers in the state of São Paulo, Timely Project - REPLICCAR III.


Eligibility Criteria:
Inclusion Criteria:

* Adults over 18 years old
* Indication for primary isolated CABG (elective or urgent status)
* Own a personal cell phone
* Have internet access
* Knowledgeable in using the device
* Full understanding and agreement regarding the informed consent form (ICF)

Exclusion Criteria:

* Indication for associated surgery
* Glycosylated hemoglobin level greater than 8%
* Creatinine clearance less than 30 mL/min
* Pre-operative atrial fibrillation or use of pre-operative anticoagulation
* Hemoglobin less than 12 g/dL
* Users of illicit drugs
* STS score greater than 4%
* Physical or mental disabilities that prevent adherence to the protocol
* Refusal by the patient or family member
Central Executive Training and Parent Training for ADHD

The goal of the current project is to combine two evidence- based treatments for school-aged children with ADHD: Central Executive Training (CET) and Behavioral Parent Training (BPT). CET is a computerized training intervention that improves ADHD symptoms and academic functioning by improving children's working memory abilities. BPT is a therapeutic intervention that improves family functioning and child oppositional-defiant (ODD) symptoms by changing parenting behaviors. Their combined use is expected to provide complementary and additive benefits, particularly if CET is delivered before BPT.


Eligibility Criteria:
Inclusion:

1. Children ages 8-12 with principal ADHD diagnoses (via K-SADS); and
2. parent AND teacher ratings in clinical/borderline range based on age and sex on ADHD Rating Scale (ADHD-5) or Behavior Assessment Scale for Children (BASC-3) Attention Problems/Hyperactivity subscales (i.e., 90th percentile or higher based on both informants).

All DSM-5 ADHD presentations will be eligible.

Exclusion:

1. gross neurological, sensory, or motor impairment;
2. history of seizure disorder, psychosis, bipolar, or severe dysregulation disorders that may interfere with participation (e.g., disruptive mood dysregulation, intermittent explosive, reactive attachment, substance use);
3. intellectual disability or Wechsler Intelligence Scale for Children (WISC-V) short-form standard score \<70;
4. conditions requiring acute intervention, e.g., active suicidality; and
5. non-English speaking child or parent.
Using Personalized Assessments in the Treatment of Childhood OCD

The primary purpose of this study is to learn whether personalized assessment of obsessive-compulsive disorder (OCD) symptoms in childhood OCD using mobile health technology are feasible and acceptable for youth and parents. The investigators will also examine whether personalized cognitive-behavioral therapy (CBT) that is informed by personalized OCD assessments yields better clinical outcomes when compared to standard CBT for youth with OCD


Eligibility Criteria:
Inclusion Criteria:

1. be 8-17 years of age;
2. meet diagnostic criteria for a primary diagnosis of OCD on a structured clinical interview;
3. have moderate OCD severity as evidenced by a CY-BOCS total score of ≥16;
4. medication free and/or on a stable dose of medication 8 weeks prior to study participation;
5. be English speaking.

Exclusion Criteria:

1. the presence of psychotic disorder, bipolar disorder, or autism spectrum disorders;
2. significant suicidal ideation that warrants medical intervention;
3. concurrent psychotherapy for OCD;
4. inability to complete scales, or attend visits.
Metformin and Transient Hyperglycemia

The purpose of this study is to determine whether metformin is an effective adjunctive treatment for transient hyperglycemia in patients with acute lymphoblastic leukemia (ALL) undergoing induction chemotherapy

ALL is the most common childhood cancer, representing one fourth of all cancers diagnosed under the age of 15 years. One of the most common side effects of ALL chemotherapy is transient hyperglycemia. Patients that develop this complication require treatment with insulin via injections to prevent severe medical complications such as dehydration, weight loss, ketoacidosis and life-threatening infections. Although insulin therapy is effective, it adds a lot of physical and psychological burden to patients because multiple daily insulin injections are required to achieve adequate blood glucose control.

In this pilot study, investigators aim to examine the effectiveness of metformin as an adjunctive treatment for transient hyperglycemia. Investigators will be comparing two groups of subjects (up to 40 subjects per group). Patients in the treatment group will be prospectively recruited, and they will be treated with metformin in addition to insulin therapy. Investigators will compare the treatment group to a historical control group acquired via chart review. These patients will have been treated with insulin alone.

Statistical comparison will be made between the two groups in terms of the length of insulin treatment, the total daily dose of insulin required, number of insulin injections, hemoglobin A1c level (measure of glycemic control over preceding 8- 12 weeks), and fructosamine level (measure of glycemic control over preceding 2-3 weeks).

Investigators hypothesize that the use of metformin will result in fewer numbers of insulin injections and fewer days of insulin therapy.

Eligibility Criteria:
Inclusion Criteria:

* ALL patients on induction chemotherapy who develop transient hyperglycemia(definition of transient hyperglycemia: random blood glucose \> 200 mg/dL x 2)
* Adequate renal function (serum Cr \< 1.5 mg/dL in males, \< 1.2 mg/dL in females)
* Adequate hepatic function (AST \< 5x upper limit of normal)

Exclusion Criteria:

* Patients with known diagnosis of diabetes or those that are already on oral hypoglycemic agents or insulin
* Allergy to metformin or any component of the formulation
* Patients with pancreatitis (lipase level \> 300 Units/L)
* Patients with active infection (positive blood culture within 48 hours of study registration)
* Patients with hemodynamic instability (PICU status, need for vasopressors within 48 hours of study entry)
* Elevated hemoglobin A1c (greater than 6.0%)
Difference Between Inhalation Anesthesia and Total Intravenous Anesthesia in Free Flap Surgery

The purpose of this study is to compare the difference between total intravenous anesthesia to inhaled anesthesia in free flap surgery.

The aim of this study is to perform a randomized controlled trial to examine the effects of different anesthetics on intraoperative hemodynamic stability during free flap surgery and postoperative complications

Eligibility Criteria:
Inclusion criteria:

Patients who need head and neck cancer excision and free flap reconstruction surgery

Exclusion criteria:

1. preoperative cognitive dysfunction, NYHA CHF \> III or LVEF \< 30%
2. preoperative documented obstructive or restrictive lung disease
3. liver cirrhosis; severe chronic renal insufficiency (GFR \< 30 ml·min-1·1.73 m-2.)
4. peripheral arterial occlusive disease expected to be a contraindication for PiCCO catheter insertion
5. Active cardiac arrhythmias that were assumed to preclude valid assessment using arterial pulse contour analysis
6. anticipated bilateral femoral arterial and central venous catheterization when the jugular and subclavian veins were not available due to surgical extent
Trial of Alpha One Antitrypsin Inhalation in Treating Patient With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

It is clear now that SARS-CoV-2 could use angiotensin-converting enzyme 2 (ACE2), the same receptor as SARS-CoV Transmembrane protease serine type 2 (TMPRSS2), a protease belonging to the type II transmembrane serine protease family, cleaves the coronavirus spike protein Serine proteases are inhibited by a diverse group of inhibitors, The best-studied serpins are antithrombin and alpha 1-antitrypsin


Eligibility Criteria:
Inclusion Criteria:

1. Positive RT-PCR) assay for SARS-CoV-2
2. Age \>18 years
3. Hospitalized
4. Able to give informed consent

Exclusion Criteria:

1. Known allergy to AAT
2. imminent death within next 24 hours
Investigating Temporal Improvements in Survival Following ST-elevation Myocardial Infarction.

The aim of the study was to use data from the Myocardial Ischaemia National Audit Project (MINAP) to investigate whether temporal improvements in survival were associated with changes in patients' baseline clinical risk or use of guideline-indicated treatments for the management of STEMI, and to determine the extent to which associations explained the temporal improvements in survival.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 years or more
* patients hospitalised with ST-elevation myocardial infarction

Exclusion Criteria:

* patients hospitalised with phenotypes other than ST-elevation myocardial infarction
Megadyne Ace Incision/Dissection Study

The Megadyne Ace™ Incision/ Dissection study is a post market, prospective assessment of the E-Z Clean ACE electrosurgical electrodes using the ACE Blade in the ACE Mode for targeted procedures such as abdominoplasty, bilateral breast reduction, bilateral breast lifts, bilateral brachioplasty, bilateral lateral thigh and buttocks lifts, or any combination thereof.


Eligibility Criteria:
Inclusion Criteria:

* Subject is \>18 years of age or \< 60 years old
* Subject is undergoing abdominoplasty, bilateral breast reduction, bilateral breast lift, bilateral brachioplasty, bilateral lateral thigh and buttocks lift, or any combination thereof
* Subject is able to discontinue anticoagulant therapy (including Aspirin)
* Subject is willing and able to comply with study follow-up procedures
* Subject is willing to provide written informed consent for their participation in the study

Exclusion Criteria:

* Subject has a history of smoking in the last 6 months prior to surgery.
* Subject has a history of type I or type II Diabetes.
* Subject has an active infection of any kind at the time of enrollment
* Subject has a known coagulopathy
Use of Eylea for the Treatment of an Optic Nerve Hemangioma

This is a single patient investigative treatment study. The patient was diagnosed with a retinal tumor in one eye. In the last 2 years, the patient has been treated with all available and conventional therapies, including intraocular injections of Avastin and Lucentis, steroids, and photodynamic therapy. Any positive results were short-term, and caused an eventual decline in central vision. Aflibercept has been shown to be effective against the growth of new vessels, secondary to macular degeneration. This study proposes that it may also be more effective in treating this particular patient and case. The study treatment plan is for 6 months initially, with the intention to continue treatment.

The treatment plan will be to administer aflibercept 2.0 mg intravitreally every two to four weeks for at least six consecutive injections. Prior to initiation of therapy and at each study visit, a full ophthalmic examination, best-corrected visual acuity, and a complete review of systems to monitor for any toxicity will be performed. In addition, the investigators will perform fluorescein and indocyanine green angiography at baseline and obtain color fundus photographs as well as spectral domain OCT images to properly document the extent and degree of activity of the vascular tumor at baseline and at all study visits.

Eligibility Criteria:
Inclusion Criteria:

* retinal hemangioma
* previously treated with conventional therapies, including Avastin, Lucentis, steroid, and photodynamic therapy, with less than ideal results

Exclusion Criteria:

* ongoing reevaluation of adverse events, including inflammation, elevated intraocular pressure, or any suspected toxicity from aflibercept
An Evaluation of a Web-based Intervention Program for Parents and Teens to Promote Safe Driving

The long-term goal of this research is to increase safe driving among novice teen drivers by increasing the quantity, quality and diversity of driving practice while accompanied by an adult. In order to achieve the long term goal of the study, the investigators have developed a web-based intervention program known as Teen Driving Plan (TDP) intended to support high quality driving practice.

Motor vehicle crashes remain the number one cause of death among teens in the United States. Teen drivers (ages 16 to 19) are four times more likely to be involved in fatal crashes than adult drivers (ages 25 to 69). Inexperience is a fundamental factor in the high crash rate for novice teens. Safe and skilled driving is a complex task that involves behaviors (e.g., skills and actions) that vary and become increasingly challenging with increasing speed, unsafe road conditions and other hazards of the driving environment. Because teens are at their lowest lifetime risk of crashing when accompanied by an adult, adult-supervised practice provides a safe way for teens to gain needed experience under a variety of driving conditions. Unfortunately, few teens receive sufficient quantity, quality and diversity of adult-supervised practice prior to licensure.

The objective of the proposed research is to compare how the driving training process and the results of that training process differ between a group of young learning permit holders in families that have access to TDP (the intervention group) from the training process and the results of that process in an otherwise similar group of teens in families with no TDP access (the control group). The investigators hypothesize that teens given access to TDP will demonstrate greater competence and safety in a standardized on-road driving assessment than teens with no TDP access.

Eligibility Criteria:
Inclusion Criteria:

* Teen 16 or 17 years of age who holds a Pennsylvania (PA) learner permit, or plans to obtain a learner permit in \< 1 month.
* Parent(s) or legal guardian(s) of a teen with his or her learner permit.
* Internet connection at home and other technical requirements to launch web program if needed.

Exclusion Criteria:

* Non-English speaking.
* Teen has practiced more than 5 hours behind the wheel or has taken more than 5 practice drives with a supervising adult prior to enrollment.
* Teen has received formal behind-the-wheel driver education instruction prior to enrollment with a certified driving instructor at a professional driver education company or in his/her school.
* Pregnant female teen subjects.
* Teen requires handicapped placard or license plate in order to drive.
Clinical Impact of Altitude Level on Surgical Outcomes of Pancreaticoduodenectomy

Very few papers examine the effect of living at high altitudes on surgical results of major operations. This research is designed to determine the surgical outcomes of PD for periampullary tumour in high altitudes and normal altitudes.

Many recent studies have suggested multiple risk factors affecting postoperative surgical outcomes of PD; THE research is designed to determine the surgical outcomes of PD for periampullary tumour in high altitudes and normal altitude.

it is a multicenter study Aseer central hospital, Saudia and from Egypt two centers Mansoura university and el Menia university

Eligibility Criteria:
Inclusion Criteria:

* periampulary tumour

Exclusion Criteria:

* liver cirrhosis,
* PG,
* advanced tumour,
* vascular resection
Functional Organization of Somatosensory Responses in the Secondary Somatosensitive Area and Insula

The implication of the second somatosensory area (SII) and the insular cortex in the processing of somatosensory inputs is now well established. However the functional anatomy of these areas hidden in the depth of the sylvian scissure remain mostly unknown.

The aim of this fMRI study is to determine the functional cartography of SII and insula. The localization of responses to different somatosensory stimuli (slight touch, warm, cold, heat pain and arthrokinesia) applied on the left hand of 25 healthy volunteers, will be compared.

Aims : Demonstrate that localization of the several types of somatosensory stimuli is different into SII and into insula. If possible, we'll determine a functional cartography of these areas.

Eligibility Criteria:
Inclusion Criteria:

* 25 healthy volunteers will be included ranging in age from 18 to 50 years
* contraception needed for women
* right handed
* All the subjects have to give their written informed consent.

Exclusion Criteria:

* pregnancy
* neurological or psychiatric disease
* drugs taken \<12h before fMRI
* contra-indications to fMRI : pacemaker, clip, metallic device
* Refusing to be informed of the presence of a cerebral abnormality, detected during MRI.
Municipality-based Post-discharge Follow-up Visits

The purpose of this study is to determine whether discharge follow-up visit by primary physician and community-based nurse affects the risk of early re-hospitalisation among high risk older people discharged from a medical ward.


Eligibility Criteria:
Inclusion Criteria:

* Patient geography (The participant live in; Holbæk Kommune, Odsherred Kommune or Kalundborg Kommune.)
* Discharged from medical ward Holbæk Sygehus.
* Frailty (Rated by following criterion: dementia or a minimum of two of the following conditions; two or more hospitalisations within 12 month prior to follow up, los of physical function, treatment of two or more concurrent medical and/or surgical conditions, psychiatric disease, multi-pharmacy of more than 6 prescription medication, suspicious of congenital disturbances, substance abuse problem, disadvantaged social network, need for increasing home care following index hospitalization.)

Exclusion Criteria:

* Not discharged to home (If the patient are not discharged to home.)
* No written consent (If the patient does not wish to participate / written consent are not signed.)
Tocolysis in Prevention of Preterm Labor

Preterm birth is defined as birth before 37 completed weeks of gestation .it occurs in 11.1%of birth globally affecting an estimated 14.9 million babies every year . It is generally accepted that approximately 65%-70%of preterm births are spontaneous,40%-45% of them due to spontaneous preterm labor and 25%-30%following preterm rupture of membranes.preterm birth represents the single largest cause of morbidity and mortality for newborn and is estimated for 29%of deaths in the first four weeks of life and also is estimated for of major cause of morbidity for pregnant women .

Tocolytic agents include a wide range of drugs that can slow or suppress uterine contractions . Tocolytic are considered advantages in spontaneous preterm labor to : (a) allow time for the fetus to mature ,potentially avoiding deleterious effects of pre-maturity . (b)allow time for antenatal corticosteroids to be administered and have clinical effect. (c) allow time for intrauterine transfer to higher-care center where neonatal intensive care facilities are available . the ideal Tocolytic agent should be effective , easy to administer , without significant material ,fetal or neonatal side effects and permit time for antenatal corticosteroids to be administered and take effect . a variety of Tocolytic treatments have been used to inhibit uterine activity in women in spontaneous preterm labor , including betamimetics , calcium channel blockers , magnesium sulfate , prostaglandin inhibitors and oxytocin receptor antagonists however there is considerable global variation in types , doses and regimens of tocolytic agents uses to manage preterm labor .

A comparison study between Ritodrine, magnesium sulfate and Nifedipine in terms of effect and morbidity will be conducted.


Eligibility Criteria:
Inclusion Criteria:

* . Gestational age between 24-37weeks

  * Symptoms such as low backache , cramping ,pelvic pressure, excessive vaginal discharge and vaginal spotting .
  * Regular uterine contractions at least of 30 seconds duration at a rate of more than 4/30 minutes
  * Cervical changes dilatation less than 3cm,effacement lessthan50%.
  * Intact membranes.

Exclusion criteria

* Active vaginal bleeding and placental abruption.
* Chorioamnionitis and intrauterine infection
* Fetal conditions : fetal death or distress, lethal congenital or chromosomal abnormalities and intra uterine growth restriction
* Maternal conditions indicate that pregnancy shouldn't be continued: eclampsia , severe preeclampsia and cardiac diseases
* Drug specific contraindications(contraindication of tocolysis)
SRS Sequential Sindilimab in Brain Metastasis of NSLSC

A phase II study on the treatment of advanced non-small cell lung cancer with brain metastasis by SRS sequential sintilimab


Eligibility Criteria:
Inclusion Criteria:

* non-small cell lung cancer patients with less than brain metastases
* Patients must have received at least the first-line anti-tumor treatment, and the front-line treatment must include chemotherapy or targeted treatment with a platinum containing combination scheme, but not anti-PD-1 / L1 treatment
* Patients who have not received intracranial local treatment before

Exclusion Criteria:

* Patients who toke major surgery within 4 weeks prior to enrollment or had ununited wounds
* Patients with hemorrhage in intracranial metastasis
Effect of Cuff Pressure of Endotracheal Tube on POST

The main objective of this study is to evaluate the association between the duration of intraoperative cuff overpressure and the development of postoperative sore throat.

For patients undergoing laparoscopic surgery after tracheal intubation, continuous cuff pressure monitoring is performed by connecting a pressure monitor to the cuff of the endotracheal tube. The incidence of postoperative sore throat was evaluated via direct questioning in all patients. This study aimed to investigate the association between the development of postoperative sore throat and the duration of overpressure in the cuff of the endotracheal tube.

Eligibility Criteria:
Inclusion Criteria:

- Patients undergoing laparoscopic surgery and endotracheal intubation under general anesthesia

Exclusion Criteria:

* Patients who already had sore throat and hoarseness before surgery
* Patients who were expected to have anticipated difficult airway
* Surgery duration \< 1 hour