cyrilzakka/clinical-trials huggingface dataset:
Postop Pain in the MICS Patients Versus Sternotomy Patients

To adequately assess postoperative pain in the coronary artery bypass surgical population a multicentered retrospective chart review was carried out; the study utilized a nonexperimental comparative descriptive study design. The retrospective review was conducted over a six-month time frame, consisting of June 2017 through November 2017, at two hospitals within the same organization. The data collection process began in late December of 2017 and January of 2018. The assessment of postop pain was performed by using a standard 11-point numeric pain rating scale on post extubation day one and the day of discharge.


Eligibility Criteria:
Inclusion Criteria:

* Patients who had an isolated coronary artery bypass surgery at Charlotte Medical Center (CMC) and CMC-Pineville
* Minimally invasive cardiac surgery
* Traditional sternotomy cardiac surgery

Exclusion Criteria:

* Documented history of any chronic pain syndromes requiring active treatment
* The "relative" recent requirement of narcotic analgesic use for pain relief prior to operation
* Any CABG operation that inadvertently resulted in an operative surgical complication
* Patient cases that resulted in a readmission within 30 days from surgery.
Dexmedetomidine Sedation Versus General Anaesthesia for Inguinal Hernia Surgery in Infants

This is a prospective randomized controlled trial comparing dexmedetomidine sedation with caudal anaesthesia, and general sevoflurane anaesthesia with caudal anaesthesia for inguinal herniotomies in neonates and infants below 3 months of age.

The investigators will compare the efficacy and adverse events associated with each of these techniques and neurodevelopmental outcomes of the infants in each group at 6 months and 2 years of age.

Several epidemiologic studies have suggested that children exposed to general anaesthesia (GA) in early childhood may be at increased risk of subsequent learning disabilities and behavioural problems. Animal studies have shown that exposure to GA agents during critical neuro-developmental windows induces neuronal apoptosis. All commonly used anaesthetic agents induce neurotoxicity with the exception of dexmedetomidine, a highly specific alpha-2 agonist which has been shown to be neuroprotective.

GA is the current standard of care for inguinal hernia repair in infants at KKH. The investigators recently demonstrated that dexmedetomidine sedation with caudal block is a feasible alternative for inguinal hernia repair in infants below 3 months of age. This prospective randomized controlled trial will compare the early and long-term outcomes of infants following inguinal hernia surgery using dexmedetomidine sedation with caudal block versus GA with caudal block.

This study aims:

1. To compare the neurodevelopment at 6 months and 2years, of infants randomized to dexmedetomidine sedation with caudal block with those randomized to GA with caudal block for inguinal hernia surgery before 3 months of age.
2. To compare the efficacy of dexmedetomidine sedation with caudal block versus GA with caudal block for inguinal hernia surgery, in terms of duration of anaesthesia, duration of surgery and surgeon's satisfaction with intraoperative conditions.

Eligibility Criteria:
Inclusion Criteria:

* Infants below 3 months of age ( corrected age 54 weeks) presenting for elective inguinal hernia repair in KKH.

Exclusion Criteria:

* History of prematurity younger than 28 weeks gestation,
* Requirement for CPAP greater than 6 cmH20 at time of surgery
* Significant cardiac pathology or cardiac conduction defects
* Unusually large hernia sacs
* Any contraindication for caudal anesthesia
* Surgeon refusal on account of anticipated prolonged or difficult surgery.
Different Premedication in Pediatric Patients

The investigators studied the effects of intranasal dexmedetomidine compared with oral midazolam with different doses for premedication in children. One hundred and twenty children aged between 2 and 12 years were randomly allocated to one of four groups:2.5µg/kg intranasal dexmedetomidine group ; 0.5mg/kg oral midazolam group;0.05 mg/kg intravenous injection midazolam group; no premedication group.

Sedation levels 10, 20, and 30min after premedication were evaluated using a 5-point sedation scale. A 4-point emotional state score was used to evaluate participators when they were separated from their parents and their response to intravenous cannulation or facemask application. Agitation scores (Pediatric Anesthe-sia Emergence Delirium \[PAED\] scale) and POV were assessed in the postanesthetic care unit (PACU).Times to endotracheal tube or laryngeal mask airway removal, discharge from the PACU and patients' satisfaction degree were also assessed.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* a recent history of upper respiratory tract infection, a known allergy to dexmedetomidine or midazolam, inability to understand the consent process or parental refusal.
Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000

The purpose of this observational trial is to gather further clinical data to confirm the safety and performance of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 in this trial population.

This is a prospective, non-randomized, non-controlled observational clinical trial. Up to 200 subjects will be enrolled at up to 6 participating clinical sites. The trial will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic valve. Patients will be followed and assessed after implant for up to 5 years.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Require replacement of aortic valve
* Signed informed consent
* Willing to return to study site for follow-up visits

Exclusion Criteria:

* Active endocarditis/myocarditis (\< 3 months)
* Myocardial infarction (\< 30 days)
* Renal insufficiency/ End-stage renal disease
* Life expectancy (\< 1 year)
* Requires multiple valve replacement/repair
* Requiring emergent aortic valve surgery
* Pregnant or lactating
Evaluation of Compensatory Reserve in Obstetrical Patients

Using a pulse oximeter, the investigators have developed an algorithm that assesses central volume status. Pregnant women present some unique opportunities for us to investigate the algorithm under different circumstances. The investigators want to specifically investigate an algorithm with women who undergo regional anesthesia such as epidurals, with women who undergo fetal surgery, and with women in labor and giving birth (and the recovery time following delivery). This will help the investigators understand the central volume status changes that women experience in these unique circumstances. The Investigators also want to put the pulse oximeter on the fetal hand when possible during certain maternal fetal interventions. The Investigators would like to examine the algorithm with data from the fetuses.

The Investigators hypothesize that the Compensatory Reserve Index (CRI) algorithm will help to guide fluid management in women undergoing regional anesthesia, giving birth, and/or undergoing maternal fetal intervention surgery.

Specific aims:

Collect noninvasive physiological waveform data from patients undergoing regional anesthesia and either fetal intervention surgery or labor and delivery at Children's Hospital Colorado in order to:

1. Determine how regional anesthesia influences CRI algorithm calculations
2. Determine if the CRI algorithm is able to detect changes in central volume status associated with fetal surgery.
3. Determine if the CRI algorithm is able to detect changes in central volume status associated with labor and childbirth specifically at the time of delivery, when most women experience some amount of bleeding.
4. Examine CRI associated with induction of regional anesthesia and determine if there is a minimal CRI below which one can expect hypotension and if there is a trend down in CRI following induction of regional anesthesia that could anticipate/predict hypotension.
5. Determine if there is a correlation between fetal heart rate abnormalities and CRI.
6. Examine CRI associated with fetal monitoring.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 14 years - 44 years or 0 day old neonates born during the protocol
2. Pregnant
3. Patients undergoing regional anesthesia and either fetal intervention surgery or labor at Children's Hospital Colorado (CHCO) or University of Colorado Hospital (UCH)

Exclusion Criteria:

1. Incarcerated
2. Decisionally challenged
3. Patients who object at any time to participating in the study
Investigation of Kinesiophobia in Volleyball Players by Gender

Kinesiophobia is a form of behavior that includes fear and anxiety in which the person tends to stay away from the movement. . In the future, this may lead to a decrease in muscle strength and condition, leading to loss or decrease in physical adequacy, avoidance of exercise and, accordingly, psychological problems. Kinesiophobia also negatively affects the success of the treatment process in athletes or normal patients.

In athletes, this situation affects the sports activity that they place at the center of their lives, causing loss of performance and, accordingly, the emergence of psychological problems. Athletes are faced with the deterioration of bone integrity during training or matches according to their branches, or they are injured by structures such as muscles, tendons and ligaments.

One of the important criteria in pain, kinesiophobia and exercise is sleep quality. Results such as sleep quality or increased stress level in insomnia and inattention may have an effect on pain or kinesiophobia. The deterioration in sleep quality leads to a decrease in the performance ability of the person, affecting the daily activity, decreasing the energy level and being in a daytime sleepy state.

Eligibility Criteria:
Inclusion criteria:

* Being between the ages of 18-30
* Taking part in Amateur Volleyball clubs

Exclusion criteria:

* Individuals under the age of 18
* Individuals who have had a surgical procedure in the last six months
* Use of NSAIDs and similar disease-modifying drugs (Diaserein, Glucosamine, etc.) in the last month.
Investigation of Instructional Approaches to Elementary Math

The overall aim of the proposed project is to test the efficacy of a relatively new, well-developed math program on the math achievement of elementary school students in mainstream classes in urban schools. Use of this program is increasing in Canada and the United Kingdom. Preliminary findings derived from uncontrolled trials and our own pilot, randomized controlled trial suggest it may yield meaningful gains in math achievement for both at-risk and achieving students, as indexed by their performance on national exams, in national math competitions, as well as on standardized measures of math achievement. However, the program has yet to be rigorously evaluated to determine its relative efficacy compared to the math programs typically used by school boards. The program provision of grade-specific teacher's guides and student workbooks (for grades 1 to 8), and minimal teacher training, points to its potential utility for full-scale implementation, should its efficacy be confirmed.


Eligibility Criteria:
Inclusion Criteria:

* The students must: have sufficient command of English to understand their teacher's instructions (as judged by their teacher, ELL students will be included provided they meet this criterion). They must have a signed parental consent form and also assent to participate in the study.

Exclusion Criteria:

* The students must have no uncorrected sensory, neurological, or physical impairments that would preclude the use of manipulatives, perceiving written math materials and figures, or hearing the teacher's instructions.
Determination of In-vivo Plasma AA Appearance From Plant Protein Fibre Products

This study aims to assess the digestibility and efficacy of the study groups previously developed innovative plant-based protein and fibre products.

Older people are at high risk of undernutrition, which leads to serious adverse health outcomes, but effective preventive strategies are lacking. Effective, new strategies should focus on the etiology of undernutrition and directly address potential causes and mechanisms underpinning undernutrition.

Reduced food intake and restricted dietary diversity are direct consequences of poor appetite. Recent studies have shown, that older persons with a poor appetite demonstrate lower intake of protein and dietary fibre, and of several nutrient-rich food groups (e.g. meat, fish, wholegrains, vegetables), after adjustment for energy intake and other potential confounders, but a higher consumption of food groups low in micronutrients (e.g. fats, oils, sweets, and sodas), compared to those with good appetite.

Enhancing dietary protein and fibre intake in older Europeans is a key objective because intake of both nutrients is sub- optimal, not only in those with poor appetite. Adequate protein intake prevents excessive decline in muscle mass and function (sarcopenia), a widespread health-issue in older persons, intensified by undernutrition. Adequate dietary fibre intake prevents constipation and impedes the development of many chronic diseases prevalent in older people. Thus, targeting adequate protein and fibre intake may be particularly beneficial in this vulnerable population.

A preparatory short-term study will be performed to assess in 10 healthy older adults the net peripheral Amino Acid (AA) appearance following ingestion of 3 selected Plant-based Proteins and Fibre (PPF) products previously developed by the wider study collaborators, compared to the reference of 30 g whey protein. Plasma concentrations of AA from arterialised blood will be measured by ion exchange chromatography in blood samples (1 drawn before and 6 during 3 hours postprandial). This step will allow the research group to compare in-vitro (previous work) and in-vivo digestibility of several PPF mixtures and identify the product with both optimal amino acid composition and sensory properties as well as optimal post-prandial plasma amino acid profile to be used in further studies.

Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling, Age 65+ years, not a heavy smoker (≤10/day), BMI 18-30 kg/m2

Exclusion Criteria:

* Medical condition or medication known to impact appetite or energy intake, consumes more than 14 (female) or 21 (male) units of alcohol per week, inability to come to study centre, self-reported cognitive impairment or diagnosis of clinical depression, heavy smoker (\>10/day)
Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity

This study will look at how the participants daily life is affected by their heart failure. The study will also look at the change in participants body weight from the start to the end of the study. This is to compare the effect on heart failure symptoms and on body weight in people taking semaglutide (a new medicine) to people taking "dummy" medicine.

Participants will either get semaglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach area, thigh or upper arm.

During the study participants will have talks with the study staff about healthy lifestyle choices including healthy food and physical activity.

The study will last for approximately 59 weeks. Participants will have 11 clinic visits and 1 phone call with the study doctor. Women: Women cannot take part if they are pregnant, breast-feeding or plan to become pregnant during the study period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age above or equal to 18 years at the time of signing informed consent.
* Body mass index (BMI) greater than or equal to 30.0 kg/m\^2
* New York Heart Association (NYHA) Class II-IV
* Left ventricular ejection fraction (LVEF) greater than or equal to 45 percentage at screening

Exclusion Criteria:

* A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
* Haemoglobin A1c (HbA1c) greater than or equal to 6.5 percentage (48 mmol/mol) based on latest available value from medical records, no older than 3 months or if unavailable a local measurement at screening
Testosterone in Metastatic Renal Cell Carcinoma Patients

Purpose

To determine efficacy and safety of Testosterone in male patients with metastatic renal cell carcinoma and fatigue receiving targeted therapy or checkpoint inhibitors.

Fatigue is a frequent symptom of metastatic renal cell carcinoma (RCC), and most common adverse event of targeted and immunotherapy.

In Phase 3 pivotal studies, 56% (9%, grade 3-4), 54% (11%, grade 3), 37% (10%, grade 3-4) and 20% (2%, grade 3) of patients had fatigue during the therapy of cabozantinib, sunitinib, axitinib or pazopanib, respectively. 59% (14%, grade 3) and 31% (5%, grade 3) of patients treated with lenvatinib/everolimus and everolimus had fatigue in registrational trials. Finally, 33% (2%, grade 3-4) of patients that received nivolumab had fatigue in CheckMate 025 study.

Testosterone may help to relieve fatigue associated with the use of tyrosine kinase, mTOR or checkpoint inhibitors. Additionally, testosterone could impact on poor prognostic factors of RCC (anemia, ECOG performance status, serum calcium). This will be first clinical trial which evaluates safety and efficacy of Testosterone in RCC patients.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically proven clear cell renal cell carcinoma;
2. CT-confirmed metastatic measurable disease;
3. First-line sunitinib or pazopanib treatment with fatigue;
4. Low level of testosterone;

4. Male, 18 years and older; 5. Normal PSA level

Exclusion Criteria:

1. Prostate and other cancers history
2. Hypothyroidism
3. History of serious cardiac arrhythmia, congestive heart failure, angina pectoris, or other severe cardiovascular disease (i.e., New York Heart Association class III or IV)
Anastomotic Leakage and Value Of Indocyanine Green in Decreasing Leakage Rates

Anastomotic leakage (AL) is one of the major complications after gastrointestinal surgery. Compromised tissue perfusion at the anastomosis site increases the risk of AL. Indocyanine green (ICG) combined with fluorescent near infrared imaging has proven to be a feasible and reproducible application for real-time intraoperative quantification of the tissue perfusion and cohort studies showed reduced leakage rate. Unfortunately, these studies were not randomized. Therefore, we propose a nationwide randomized controlled trial to identify the value of ICG for AL in colorectal anastomosis.


Eligibility Criteria:
Inclusion Criteria:

1. Scheduled for laparoscopic or robotic-assisted colorectal resection with primary anastomosis;
2. Patients aged over 18 years old;
3. Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions;
4. Signed informed consent prior to any study-mandated procedure;

Exclusion Criteria:

1. Known allergy or history of adverse reaction to ICG, iodine or iodine dyes;
2. Severe liver or kidney insufficiency;
3. Hyperthyroidism or a benign thyroid tumour;
4. Pregnant or breastfeeding women;
5. Scheduled for palliative surgery or terminal ill
6. Scheduled for a diverting stoma
7. Any condition that the investigator considers to be potentially jeopardizing the patients well-being or the study objectives (following a detailed medical history and physical examination;
8. Subject taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol, nitrofurantoin, probenecid;
9. Emergency surgery
Hydoxycarbamide and L-Carnitine Therapy in Sickle Cell Anemia

The role of the combination therapy of hydroxyurea and L-Carnitine was studied in thalassemic patients. nevertheless its role in sickle cell anemia patients was not investigated

Sickle cell disease (SCD) is a common monogenic disorder affecting over 100,000 people in the United States alone, and millions more worldwide. This often devastating disease is characterized by red blood cell (RBC) sickling; chronic hemolytic anemia; episodic vaso-occlusion associated with severe pain and inflammation; acute and cumulative organ damage that manifests as stroke, acute chest syndrome, sickle lung disease, pulmonary hypertension nephropathy and end-stage renal disease; and other chronic morbidities.

Lives of patients with SCD are characterized by frequent episodes of severe pain (vaso-occlusive events or "crises"); acute organ dysfunction, including a pneumonia-like syndrome termed acute chest syndrome, and strokes starting in childhood; and progressive multi-organ damage. Not surprisingly, patients with SCD have very high health care utilization (over $1 billion/year in healthcare costs in the United States alone, and a median life-expectancy of only \~45-58 years, compared to the life expectancy of 78.2 years overall in the United States.

Although it is licensed in the United States for administration to sickle cell patients who have ≥ 3 crises a year in steady state, hydroxyurea (HU) remains unlicensed in most countries where it is regarded as an experimental drug In those areas, where HU is unlicensed for SCD, it is offered to patients who have ≥ 5 crises a year; or 3-4 crises a year with either neutrophil count ≥ 10 × 109/L or platelet count ≥ 500 × 109/L in steady state ; bearing in mind that the reference range for neutrophil count in black people is 1-3 × 109/L, and is 100-300 × 109/L for platelets .

Since high neutrophil count in steady state is a marker of severe SCD , these criteria usually identify individuals who have a clinical course sufficiently severe to ensure that the benefits of hydroxyurea therapy justify the potential risks. HU therapy is offered if the patient does not want to have (more) children, and is weighed against any severe impairment of liver or kidney function, or blood cytopenia. HU is unlicensed in most countries because the long-term adverse effects are unknown, not because the clinical efficacy is in doubt. In fact, after over 9 years of follow-up, HbSS subjects who received HU in the US placebo-controlled trial, had significantly less painful crises, acute chest syndrome, and mortality . Potential long-term toxic effects that reduce enthusiasm for HU include teratogenicity, carcinogenesis and, for young children, impaired cognitive development.

Eligibility Criteria:
Inclusion Criteria:

* Patients with sickle cell disease
* Not welling for pregnancy in females or to father a baby in males
* Frequent episodes
* Non-compliance to transfusion

Exclusion Criteria:

* \<18 years
* Hypersensitivity to hydroxycarbamide or L-Carnitine
* Pregnancy
* Other chronic infection or inflammation
Patient Registry: Radio Frequency Ablation of Barrett's Esophagus Using HALO System

The purpose of this study is to provide a tool for physicians to compare outcome data related to the use of the HALO Ablation Systems. This study is a single-center patient registry which will contribute to a framework for treatment and follow-up of patients with Barrett's Esophagus.


Eligibility Criteria:
Inclusion Criteria:

* candidate for ablation of Barrett's Esophagus with the HALO Ablation System (Prospective)
* received an ablation with the HALO Ablation System to treat Barrett's Esophagus (Retrospective)
* candidate agrees to proposed follow-up schedule of yearly surveillance following treatment
* signs consent

Exclusion Criteria:

* has not been diagnosed with Barrett's Esophagus