cyrilzakka/clinical-trials huggingface dataset:
Fast-Track in Cardiac Anesthesia

The introduction of fast-track extubation procedures following cardiac surgery has significantly shortened hospitalization times in intensive care units. In this study, it was aimed to determine the obstacles to the early recovery of patients who underwent cardiac surgery in the crisis environment that developed with the pandemic.

After the time we struggled to overcome the many crises that the pandemic period brought to our lives, it has been clearly seen that the decrease in the number of nurses and doctors and the limitation of the number of beds allocated for postoperative intensive care have been mandatory attempts due to the shift of personnel to areas to fight the pandemic. The fact that cardiac surgery operations are not elective and cardiac patients cannot wait for a long time due to their existing pathologies has led physicians to strive to provide the best service with available resources. To ensure that the cardiac surgery operating room and intensive care beds of our hospital can be used more efficiently and to take initiatives to optimize the recovery in the postoperative period are among the important goals of today and the future. The reason for this is not only to reduce costs and loss of workforce but also to be ready for any crisis time. In addition, it is aimed to perform the operations of critical patients without delay and to successfully discharge them. In the postoperative period, if the functions of many basic organ systems can provide the necessary ideal conditions, the patients can be extubated within 8 hours in fast-track cardiac anesthesia (FTCA) programs. Some problems persist or occur in patients with functional problems such as hemodynamics, cardiac, and respiration who do not meet the extubation criteria. For all these reasons, a prospective, cross-sectional study was planned to focus on daily standard practices and improve areas of failure.

Accordingly, this study aimed to examine the preoperative, intraoperative, and postoperative characteristics of patients who underwent cardiac surgery, and to investigate the factors in patients who could not be extubated within 8 hours after surgery.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients who underwent elective or emergency cardiac surgery

Exclusion Criteria:

* Patients undergoing pediatric cardiac surgeries
Medrol Dose Packs for Post-Operative Pain Control

The investigators primary purpose of this study is to determine if the addition of a short course use of steroids following surgery for Adolescent Idiopathic Scoliosis (AIS) will improve post-operative pain management and shorten hospital length of stay.

Post-operative pain control following AIS surgery is challenging. Sub-optimal pain management results in emotional distress and prolonged hospital length of stay. Previous studies have shown that a short course of steroids following spine surgery is safe and improves pain control. To better understand the effects of the addition of steroids to a routine pain management strategy, a randomized prospective study with and without steroids will determine the benefit, if any, to the addition of steroids to the investigators already used pain protocol.

Eligibility Criteria:
Inclusion Criteria:

* age range of 10-21
* received AIS surgery

Exclusion Criteria:

* participants out of the age range 10-21
* other forms of scoliosis (not AIS)
Education Against Tobacco Randomized Trial

A two armed randomized trial is evaluating the effect of the medical-student-delivered school-based intervention Education Against Tobacco on the smoking behavior of adolescents in 7th grade of secondary school. The primary endpoint is the change in smoking prevalence between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Pupils of 7th grade of regular secondary schools in Germany

Exclusion Criteria:

* Not fulfilling the inclusion criteria
Safety Study of Mocetinostat in Combination With Azacitidine in Subjects With MDS

Mocetinostat is an orally administered histone deacetylase (HDAC) inhibitor. Azacitidine is a hypomethylating agent (HMA) used to treat MDS. In this study, patients with intermediate- or high-risk MDS will receive treatment with mocetinostat and azacitidine to evaluate the safety of the study treatment. Safety assessments will include echocardiograms, electrocardiograms and routine safety laboratory studies (hematology and serum chemistry). In addition, clinical response to treatment will be monitored using bone marrow aspirates or biopsies, and other routine methods.

The study will include multiple cohorts of patients. In the first cohort, patients may have previously received treatment with hypomethylating agents such as azacitidine. In later cohorts, prior treatment with this class of anti-cancer agents will be excluded. Later cohorts will include patients that are receiving this class of agents, specifically azacitidine, for the first time.

Eligibility Criteria:
Inclusion Criteria:

Diagnosis of intermediate- or high-risk (IPSS criteria) myelodysplastic syndrome.

Cohort 1: Any prior treatment, enrollment complete. Cohort 2: Limited or no prior treatment for MDS. Prior treatment should not include hypomethylating agents such as azacitidine or decitabine, or HDAC inhibitors.

ECOG Performance Status 0 or 1.

Exclusion Criteria:

Current or history of small, moderate or large pericardial effusion, tamponade and/or pericarditis.

Significant cardiac abnormalities such as recent myocardial infarction, congestive heart failure ≥ Class 3, or symptomatic, uncontrolled atrial fibrillation, atrial flutter or sinus tachycardia.

Prolonged QT/QTc interval.

Other active cancer excluding basal cell carcinoma or cervical intraepithelial neoplasia.
The Study of Massively Parallel Sequencing in Early Detection for Gynecologic Malignant Tumor

As human aging, 50% of women will be faced with the threat of cancer, especially gynecological malignancies. Ovarian, cervical and endometrial cancer are three major gynecological malignancies. In recent years, the incidence of cervical cancer, especially in young women significantly increased; ovarian cancer, although the incidence of malignant tumors in the female reproductive system ranked second, but its mortality rate already in the first place; and the morbidity and mortality of endometrial cancer is also rising.

The key to gynecologic malignancies is how to early diagnose and treat. With the advancement of science and technology, such as molecular biology techniques widely used in the medical field, early diagnosis, proper treatment and other aspects in gynecologic malignancies is expected to achieve a breakthrough. Genome-wide scan strategy, making the whole genome for linkage analysis for gynecological malignancies possible. Therefore, the investigators intend to find specific mutations to provide a new early screening approach for gynecological malignancies, which in later result in early diagnosis and specific treatment for gynecological malignant tumors.


Eligibility Criteria:
Inclusion Criteria:

* Female aging from 16 to 75-year old;
* Preoperative diagnosis of gynecologic malignancies;
* Have the ability to comply with Research programs;
* Voluntarily participate in the study and signed an informed consent form

Exclusion Criteria:

* The cases do not meet the inclusion criteria should be removed from,indicating the reason for excluding.
Dexamethasone Reduces Postoperative Emesis by Decreasing PGF2α and LTC4 Levels

Hypothesis: Dexamethasone reduces postoperative emesis in thyroidectomy and mastectomy patients.

This study has been done to further study the effectiveness of dexamethasone in the prevention of postoperative emesis after breast and thyroid surgery and at the same time, the mechanism of action was investigated. In this prospective, randomized controlled trial it was hypothesized that corticosteroids exert their antiemetic effects in postoperative period via plasma prostaglandin F2 alpha (PGF2 α) and plasma leukotriene C4 (LTC4) inhibition.

Eligibility Criteria:
Inclusion Criteria:

* breast and thyroid cancer patients no neoadjuvant treated no NSAID or steroid usage heallthy volunteers, signed the informed consent

Exclusion Criteria:

* ones who did not sign the consent form NSAID or steroid users
Therapeutic Riding and Neuromuscular Disease

The purpose of this current prospective study is to assess the effects of a Therapeutic Riding exercise program conducted in patients suffering from neuromuscular disease. The exercise intervention aims at improving gross motor function, gross motor performance, balance, spasticity, posture and quality of life. Patients were randomized according to age, sex, mental ability and gross motor function. Furthermore, patients will be subdivided into categories of central nervous system (brain/ spinal cord) and peripheral (peripheral nerve or muscle) diseases. The exercise program duration will be 12 weeks, once a week with 30-40 minutes sessions. Six measurements will be conducted: the Gross Motor Function Measure, the Gross Motor Performance Measure, the Quality of life Questionnaire for Children, the Pediatric Balance Scale, the dynamic plate in combination with x-ray for posture control, the Modified Ashworth Scale for spasticity and the Wisc 3 for mental ability. The results will be collected and evaluated using the statistical programme SPSS.


Eligibility Criteria:
Inclusion Criteria:

* Children with neuromuscular disease
* Parental consent
* Sitting posture capability
* Hip abduction capability on horseback
* Ability to communicate and collaborate with the researcher

Exclusion Criteria:

* Children with Scheuermann disease
* uncontrolled seizures (A) child with generalized seizure over 2 minutes in the last three months (B) Children who are not well-adjusted levels of antiepileptic drugs.
* musculoskeletal disorder that may be aggravated by the movement of the horse such as atlantoaxial instability, osteoporosis etc.
* Scoliosis \> 30 degree
* Allergy to dust
A Quality Improvement Approach to the Management of Chronic Lymphocytic Leukemia

This project addresses the need to improve physician knowledge and clinical practice patterns related to quality of life (QoL) concerns for patients with chronic lymphocytic leukemia (CLL).

This multifaceted initiative will include evaluating patient perspectives on their QoL, evaluating provider perspectives on managing QoL, and providing education to the whole CLL care team (hematologists/oncologists, nurse practitioners, physician assistants, and nurses) on contemporary approaches for individualized, patient-centered management of CLL. Providers, including physicians, nurse practitioners, and physician assistants will participate in educational initiatives geared towards enhancing their knowledge and confidence with managing QoL concerns for patients with CLL. Pre and post surveys will be conducted with providers to evaluate change in these areas. The project aims to train this team on how to enhance communication with patients and caregivers as a means to increase patient engagement in care and QoL in this population.

Eligibility Criteria:
Inclusion Criteria: Clinician

* Participant must be a hematologist, oncologist, nurse practitioner, or physician assistant who practices medicine in the Duke Cancer Network
* Participant treats patients with CLL
* Participant is willing to participate in the educational component of this project

Inclusion Criteria: Patient

* Patient has a diagnosis of Chronic Lymphocytic Leukemia
* Patient is over the age of 18
* Patient is being treated at a Duke Cancer Network affiliate site,
* Patient is expected to see their physician or another member of their care team at least 3 times annually.
* Signed informed consent

Exclusion Criteria: Clinician

* None

Exclusion Criteria: Patient

* Patient is Non-English speaking
* Patient diagnosed with CLL \< 60 days ago
A Study of MTP-131 Topical Ophthalmic Solution in Subjects With Diabetic Macular Edema and Non-Exudative Intermediate Age-related Macular Degeneration

This is a Phase 1/2, open-label, dose-escalation clinical study, enrolling 21 subjects in one of the two treatment groups to determine the effects of topical ocular administration of low dose or high dose MTP-131 given twice a day in subjects with Diabetic Macular Edema and Age-Related Macular Degeneration.


Eligibility Criteria:
Inclusion Criteria:

* General:

  1. Adults aged ≥18 and ≤ 80 years
  2. Women of childbearing potential must have a negative urine pregnancy test at Baseline and agree to use a highly effective method of contraception throughout the study and 60 days after the last dose of study drug.
* DME Treatment Group:

  1. Central subfield thickness (CST) ≥325 microns as measured by spectral domain optical coherence tomography (SD-OCT) at Screening and Baseline Visits
  2. BCVA (ETDRS) no better than 20/25 in the study eye
  3. BCVA (ETDRS) no worse than 20/640 in either eye
* AMD Treatment Group:

  1. Non-exudative, intermediate age-related macular degeneration defined as an eye(s) having extensive intermediate drusen (10 or more drusen 63μm - 124μm) or large drusen (1 or more ≥125 μm) with no evidence of advanced AMD (i.e., no choroidal neovascularization or macular atrophy)
  2. BCVA (ETDRS) no worse than 20/400 in either eye

Exclusion Criteria:

* General:

  1. Inability to self-administer eye drops
  2. Current use of or likely need for systemic medications known to be toxic to the lens, retina or optic nerve (for example deferoxamine, chloroquine/hydroxychloroquine \[Plaquenil\], tamoxifen, phenothiazines and ethambutol)
  3. Any medical condition that, in the opinion of the investigator, would preclude safe participation in the study or completion of all study requirements and examinations
  4. Have a glycosylated hemoglobin (HbA1c) ≥ 12%
* Ocular Conditions:

  1. Any ocular condition in the study eye that in the opinion of the investigator would prevent improvement in visual acuity or successful completion of any study examination
  2. Ocular hypertension or glaucoma, dry eye, and any other ocular pathology in the study eye requiring treatment with topical ophthalmic drops

     * Other protocol-defined inclusion/exclusion criteria may apply
Icariin to Prevent Corticosteroid-related Memory Changes

The purpose of this study is to investigate the pharmacokinetic properties of icariin, an active ingredient in the over-the-counter supplement, Horny Goat Weed.

The purpose of this study is to investigate the pharmacokinetic properties of icariin, an active ingredient in the over-the-counter supplement, Horny Goat Weed.

Healthy volunteers will be randomly assigned to a 5 day course of icariin at 100 mg/day, 200 mg/day, 400 mg/day, or 800 mg/day, or a matching placebo.

24 hours of blood samples will be drawn for pharmacokinetic analysis. Side effects will be assessed for the full 5 days.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* Ages 18 - 50 years
* BMI between 18.5 and 30
* Ability to read and speak English
* Education of 12 or more years or equivalent (at least GED received)

Exclusion Criteria:

* Medication changes in the past 30 days
* History of psychotropic medication therapy in the past 30 days
* Current or past 30 days opioid therapy
* Current or past 30 days erectile dysfunction therapy
* Significant medical conditions
* Hypertensive blood pressure, defined as either systolic pressure \> 140 or diastolic pressure \> 90
* Baseline heart rate \> 100 bpm or \< 50 bpm
* History of major psychiatric illness
* History of drug/alcohol abuse or current tobacco use
* Vulnerable populations including pregnant or nursing women, the incarcerated, or individuals with severe cognitive disorders
* History of allergic reaction or contraindication to icariin
* Baseline QIDS score \> 7, current suicidal ideation, or history of suicide attempt
* Education history that includes Special Education or history of mental disability
* Clinically significant abnormalities on baseline labs and ECG results
* Current participation in any other pharmacotherapy studies
Short-term Regulation of Energy and Macronutrient Balance: Impact of Energy Flux

Aim of the study is to investigate the impact of energy flux (achieved by changes in physical activity) under the conditions of energy balance, caloric restriction and overfeeding in healthy subjects.

A low energy flux is achieved by low energy expenditure, equivalent to low physical activity and with a corresponding low energy intake. A high energy flux is achieved by high energy expenditure, equivalent to high physical activity and with a corresponding high energy intake, respectively.

The protocol of this randomized, intra-individual nutrition intervention includes 12 one-day interventions with 3 different levels of energy flux and 4 different diet conditions.

Eligibility Criteria:
Inclusion Criteria:

* 20-40 years of age
* healthy
* BMI between 18.5 and 31 kg/m2

Exclusion Criteria:

* smoking
* food allergies
* alternative nutrition habits like vegetarian / vegan
* chronic diseases
* regular medication intake
* claustrophobia
* weight loss \> 5 kg in the last 3 years
Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner

The purpose of this project is to compare the performance of the Pediatric Vision Scanner (PVS) with the Gold Standard Examination to determine the effectiveness of the PVS at detecting amblyopia and strabismus.


Eligibility Criteria:
Inclusion:

* 2-6 years old
* complete ophthalmic examination including cycloplegic refraction conducted on the same day or within 3 months
* strabismic, anisometropic, or normal (normal eye examination and refractive error according to AAPOS guidelines)
* parent provides informed consent

Exclusion:

* other ocular disease (includes media opacities, anomalous optic nerve, ptosis, lid hemangioma, conjunctivitis, blepharitis, symptomatic NLD) or systemic disease (JIA, JRA, neurofibromatosis)
* developmental delay
* strabismus surgery in the past 6 months
Physical Activity in Pediatric Cancer (PAPEC)

The aim of this randomized controlled trial on Physical Activity and Pediatric Cancer (PAPEC) is to assess the impact of an exercise program intervention in pediatric cancer patients undergoing chemotherapy for solid tumors. The investigators hypothesized the intervention will have a beneficial effect on the study outcomes.

Sixty patients, of both sexes, children will be recruited for this trial with an age range between 4 to 16 years old, undergoing treatment for primary tumors (excluding central nervous system tumors). Each participant will be assigned randomly (with blocking on sex) to either intervention or control (usual care) group.

The intervention group will participate in combined inpatient physical training (aerobic + strength) over neoadjuvant chemotherapy. The intervention will include three weekly exercise sessions of 60-90 minutes, and will be held in child's room or in a pediatric gym specifically enabled on the aforementioned hospital, depending on the children's health status.

Primary outcomes \[cardio-respiratory capacity (peak oxygen uptake), muscle strength (6RM leg and bench press, and lateral row), functional capacity ('Timed Up and Down Stairs test', and '3 m and 10m Time Up and Go tests'), physical activity levels (determined by accelerometry) and quality of life "Child Report Form of the Child's Health and Illness Profile-Child Edition", Adolescent Edition and Parents Report Form )\] and secondary outcomes \[immune function (immune cell subpopulations, natural killer cells' cytotoxicity), inflammatory profile (blood levels of 47 cytokines) and leukocyte telomere length\] will be measured in both groups in the following time points:

(i) before the exercise intervention (immediately after diagnosis and before the start of treatment); (ii) after the exercise intervention (upon termination of neoadjuvant chemotherapy); and iii) after a detraining period (2 months after the intervention).

Eligibility Criteria:
Inclusion Criteria:

* age range between 4 to 16 years old, undergoing treatment for primary tumors (excluding central nervous system tumors) treated in the Hospital Infantul Niño jesús and residents in Madrid community. -

Exclusion Criteria:

* age\<4 years or \>16 years, other tumours
Prognostic Factors Affecting Recurrence and Disease-Free Survival After Surgical Resection for Cancer Rectum

Tumor recurrence after curative surgical resection for rectal cancer is a serious complication that greatly affects the overall morbidity and the outcome. This study aims to identify the different prognostic factors affecting recurrence and disease-free survival after surgery.

A retrospective analysis of patients operated for cancer rectum with curative intent from.

Exclusion criteria will include patients with familial adenomatous polyposis, multiple synchronous or metachronous rectal cancers, and death within 3 months. Incomplete patients' files and patients that lost follow-up will be excluded.

Demographic, histopathological, follow up and outcome data will be collected from completed patients' files. Demographics include age, gender, family history, and chief complaint at the presentation. Histopathological data include tumor grade, vascular-perineural invasion, the total number of lymph nodes removed, and positive lymph nodes.

Lymph node ratio will be defined as the ratio of positive lymph nodes to the total number of retrieved lymph nodes in a histopathology specimen. Disease-free survival will be calculated for each patient based on the time of surgery to the time of recurrence detection.

Eligibility Criteria:
Inclusion Criteria:

* Patients who had curative surgery for cancer rectum.

Exclusion Criteria:

* Patients with familial adenomatous polyposis (FAP), multiple synchronous or metachronous rectal cancers, and death within 3 months
* Patients that lost follow-up will be excluded.
Differential Effects of Oral and Intranasal Oxytocin on Attention Control

The main aim of the present study is to investigate whether oxytocin (24IU) via different routes have divergent effects on attention control in a social-emotional saccade/antisaccade eye-tracking paradigm.

Previous studies have demonstrated oral and intranasal oxytocin's divergent effects on arousal rating and neural responses to emotional faces, however, it remains unclear whether different routes of oxytocin treatment would have differential effects on attention processing to social stimuli. Based on the previous registered studies (ClinicalTrials.gov ID: NCT04493515 and NCT03486925) from our group using a validated emotional anti-saccade task with social stimuli (emotional faces) and non-social stimuli (oval shape) have separately explored oral and intranasal oxytocin's modulatory effects on attention processing, the present study aims to conduct a secondary analysis of the previously acquired data to directly compare oxytocin's effects on attention control to social emotional stimuli via different routes. To this end data from subjects who underwent intranasal oxytocin administration (n = 33, NCT03486925) will be compared with data from subjects who underwent oral oxytocin or placebo administration (n = 36, or 37 respectively; NCT04493515). To further control for non-treatment related factors the intranasal placebo and oral placebo groups from the previous studies (ClinicalTrials.gov ID: NCT03486925 and NCT04493515) will be compared with respect to primary and secondary outcome measures of the trial, in particular general and emotion-specific effects on attentional control.

Eligibility Criteria:
Inclusion Criteria:

* Male, healthy participants
* Non smokers

Exclusion Criteria:

* Previous or current medical, psychiatric, neurological disorder
* Regular medication
* Use of any psychoactive substances in the 24 hours before experiment
* Contra-indications for eye-tracking data acquisition