cyrilzakka/clinical-trials huggingface dataset:
Effects of Goal-directed Fluid Therapy on Post-operative Outcomes in Children Undergoing Scoliosis Repair

Surgery for scoliosis correction, the abnormal curvature of the spine, is a major procedure often undertaken in adolescents. In adult anesthesia, there is a large volume of literature debating how to optimize fluids administered during surgery, as both too much fluid and too little fluid are associated with worse outcomes. The investigators will compare fluid administration based on the measured amount of blood pumped by the heart during each heart beat (goal-directed therapy), against standard anesthetic management. The main outcomes are a) post-surgical kidney dysfunction, b) prevalence of intraoperative hypotension, c) volumes of administered fluids, and d) length of hospitalization.

1. Written informed consent from parent/guardian and assent from the patient will be obtained.
2. Each patient will be randomized into either the control arm or Cardio Q directed fluid therapy arm.
3. The following standard monitors will be placed before induction of anesthesia: electrocardiography, non-invasive blood pressure and pulse oximetry. The patient is anesthetized in the supine position using a standardized anesthetic technique. All attempts will be made to maintain normothermia
4. Following induction of anesthesia, the following will be placed: invasive arterial cannula, large bore intravenous cannula, Bispectral index monitor, temperature probe and central venous cannula (if needed).
5. Cardiac output monitor: Following induction of anesthesia and after placement of appropriate lines and monitors, a transoesophageal doppler (TED) probe will be inserted through the mouth into the esophagus and positioned correctly. A normal saline infusion will be started once the patient is anesthetized at 0.5 ml/kg/hour in the line where the drugs will be infused.

   1. Control Group: In this group, fluid administration, using boluses of 5ml/kg of plasmalyte at the anesthesiologist's discretion will be used. Anesthesiologists will be blinded to the cardio-Q numerics on the monitor. The flow waveform and sound will be available to optimize probe position.
   2. Intervention groups: Boluses of 5ml/kg plasmalyte will be given when: either MAP drops 20% from baseline or stroke volume drops 15% from baseline. If the patient is fluid responsive, a further 5ml/kg of fluid will be given.
   3. Vasopressor use: MAP (and stroke volume) becomes unresponsive to a fluid bolus then a bolus of phenylephrine or ephedrine may be given at the anesthesiologist's discretion.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing scoliosis repair
* ASA physical status classification system (ASA) I-III

Exclusion Criteria:

* Pre-existing chronic kidney disease
* Oropharyngeal disease, e.g. pharyngitis
* Esophageal disease, e.g. heartburn, esophageal varices or hiatus hernia.
* Coagulopathy
* Scheduled for two stage procedures
SMARTCap Stroke Study: A Field Deployable Blood Test for Stroke

The hypothesis is that a stroke causes release of purines from brain into blood and that this is a very early biomarker of brain ischaemia. The investigators propose a simple blood test of substances (the purines) that result from cellular metabolism and are produced in excess when brain cells are starved of oxygen and glucose (as occurs during a stroke).

In this study, the investigators propose to use newly developed biosensor technology (SMARTCap) to directly address whether purines are indicators of real strokes, and can distinguish strokes from other conditions with similar symptoms, more rapidly.

Eligibility Criteria:
Inclusion Criteria:

1. Stroke patients: Admitted to the Hyperacute Stroke Unit having a suspected stroke within 1 hour of admission. Important to note that not all these patients will have suffered a stroke
2. Control participants: Relatives of patients admitted to the stroke treatment pathway, who are healthy and have no signs of cardiovascular illness
3. Healthy volunteers

Exclusion Criteria:

1. Stroke patients: Delay in admission exceeds the time window of 4 hours between stroke symptoms and admission
2. Control participants: Obvious signs or history of cerebrovascular disease
3. Unhealthy volunteers
Whole Blood Metal Ion Concentrations in Metal-on-metal Total Hip Arthroplasty and Hip Resurfacing

The investigators aimed to investigate the possible differences in metal ion concentrations in patients following one of two types of metal-on-metal articulating hip prosthesis regarding chromium and cobalt concentration, radiological findings, patient reported outcome measures and rate of revision at 5-years follow up.

The metal-on-metal large-diameter-head (MoM-LDH) hip replacements increased in popularity during the start of the 21st century. Subsequently reports raised concerns regarding adverse reactions due to elevated chromium (Cr) and cobalt (Co) concentrations as well as high rates of other complications and revisions.

This was a single center parallel-group randomized controlled trial. The primary outcome was to compare Cr and Co concentrations at 5-years follow up following MoM-LDH total hip arthroplasty (MoM-LDH-THA) or MoM-LDH hip resurfacing (MoM-LDH-HR).

Secondary outcomes were radiological findings, patient reported outcome measures and revision rate at 5-years follow up.

The study was prematurely terminated in 2012 due to alerts and safety communications from the Danish national regulatory agency regarding early failure rates and high incidence of ARMD in patients with MoM hip implants \[13\]. At that time the study population consisted of 75 patients out of 200 planned for inclusion.

Eligibility Criteria:
Inclusion Criteria:

* Primary or secondary hip osteoarthritis eligible for hip replacement surgery
* Able to give informed consent
* Able to complete follow up consultations

Exclusion Criteria:

* Earlier or present infection of the hip
* Severe systemic or metabolic disease leading to weakening of the bone
* Severe congenital hip dysplasia
* Osteoporosis and/or renal disease
Effectiveness of Kaltenborn Mobilizations Versus Muscle Energy Technique in Adhesive Capsulitis.

Total of 30 patients are selected according to inclusion criteria by convenient sampling and randomly allocated by sealed envelop method into two groups. Group 1 is treated with Muscle energy technique(Post isometric relaxation) and Group 2 is treated with Grade II,III Kaltenborn mobilizations and both groups also receives conventional therapy in form of Codman exercise and Wall ladder exercises.Data will be collected at baseline then after 2 weeks and after 4 weeks of intervention.

The purpose of study is to determine effectiveness of muscle energy techniques(Post Isometric relaxation) and Kaltenborn mobilizations and to compare the effectiveness of both techniques on pain and functional disability in patients with Adhesive capsulitis.Several studies about the effects of Maitland mobilizations and Muscle energy technique have been conducted. Evidence regarding the comparison of Kaltenborn mobilizatuons and post isometric relaxation is sparse. There has been no work regarding effectiveness of these two techniques in improving pain and functional disability in patients of Adhesive capsulitis.

Kaltonborn Mobilizations involves the application of a passive sustained stretch technique to enhance joint mobility without articular surface suppression. The forces applied to increase joint mobility are graded from I-III. Grade I applies a distraction of minor intensity that hardly causes stress within the joint capsule; it is often used to decrease pain. Grade II refers to a force that stretches the periarticular tissue; such stimulus is colloquially referred to as "taking up the slack." Finally, Grade III force causes enough distraction or gliding so that joint capsule can sufficiently stretch; it is often used for enhancing ROM.

MET is unique in its application as the client provides the initial effort while the practitioner facilitates the process. One of the main uses of this method is to normalize joint range, rather than increase flexibility, and techniques can be used on any joints with restricted Range of Motion (ROM) identified during the passive assessment. The main effects of MET can be explained by two distinct physiological processes: Post Isometric Relaxation (PIR) and Reciprocal Inhibition (RI). Post isometric contraction decrease muscle tone in single group of muscle after brief period of submaximal isometric contraction of same muscle.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 60 years.
* Duration of complaint for more than 3 months.
* Gender: Both Male and Female.
* Patients with idiopathic frozen shoulder
* Patients having restriction in more than 2 ranges
* Patients with diabetes

Exclusion Criteria:

* Shoulder dislocation, fracture or labral tear.
* Shoulder girdle motor control deficit associated with neurological disorder.
* Any bony deformities acquired or congenital in glenohumeral joint.
* Patients with language barrier.
Effect of Remote Ischemic Postcondioning on Glymphatic System in Acute Stroke

Investigators aimed to investigate the changes of glymphatic function after remote ischemic postcondioning treatment in acute ischemic stroke .


Eligibility Criteria:
Inclusion Criteria:

* The patient was 18-80 years old;
* The NIHSS score was ≤ 25 and NIHSS \> 5，Glasgow coma score ≥ 8;
* The patients were diagnosed as anterior circulation cerebral infarction and could start remote ischemic postcondioning within 24 hours after onset
* Normal to random time within 24 hours
* Written informed consent signed by patients or their families

Exclusion criteria:

* patients receiving thrombolysis or endovascular therapy;
* modified Rankin scale (mRS) score ≥ 2 before this attack;
* other intracranial lesions, such as cerebral hemorrhage, cerebral venous disease, severe subclavian artery stenosis and other diseases involving the brain;
* Arterial blood pressure ≤ 90/60mmHg or ≥ 180/100mmHg after treatment.
Ultrasound Evaluation of the Jugular Venous Pulse (US-JVP)

The jugular venous pulse (JVP) reflects changes in the right atrial pressure and its evaluation can be useful in managing many emergency conditions for guiding the fluid administration as well as in the diagnosis and/or prognosis of many heart and lung diseases. The present study aims: i) To validate a novel ultrasonographic (US) technique for obtaining the JVP from a high-resolution B-mode sonograms sequence, recording the changes of the cross-sectional area (CSA) of the internal jugular veins (IJV) over the cardiac cycle; ii) To develop physical and mathematical models capable of providing an indirect estimate of central venous pressure (CVP) from the changes in IJV-CSA acquired through the US investigation, and iii) To test the transferability of the novel US-JVP technique in a clinical setting.

The study will be articulated in different phases, encompassing data collection, development of physical and mathematical models, statistical evaluations, and software implementation. The clinical experimental phase of the study (data collection) will involve hospitalized adult patients requiring a scheduled central venous catheterization and measurement of the CVP as part of their usual care. The latter will be used as the gold standard measure of CVP for the subsequent data processing and analysis. A small sample of healthy adult volunteers will also be recruited only for the non-invasive US evaluation of the JVP. The validation processes will include assessment of the diagnostic power of the US-JVP estimated CVP values and US-JVP waveforms, including evaluation of sensibility, specificity, predictive positive and negative values, accuracy and precision.

Eligibility Criteria:
Inclusion criteria:

* Adult (age ≥18 years) hospitalized patients, spontaneous breathing, requiring a scheduled central venous catheterization and measurement of the central venous pressure as part of their usual care;
* Capacity to give informed consent.

Exclusion criteria:

* Central venous catheterization via the internal jugular venous access
Assess Vitamin D Levels in Those With & Without Thyroid Cancer

The purpose of this study is to evaluate Vitamin D levels in thyroid cancer patients with active disease compared with thyroid cancer patients in remission and patients with thyroid nodules.

Thyroid cancer is the most common endocrine related malignancy, increasing in incidence in recent years. There are relatively few, well known factors, both genetic and environmental, which predispose to the development of thyroid cancer. Vitamin D deficiency has been associated with other cancers, but the association between vitamin D and thyroid cancer is unknown. We plan to do a case control, pilot study to evaluate the relationship between vitamin D levels and thyroid nodules, thyroid cancer in remission, and active thyroid cancer.

Eligibility Criteria:
Inclusion Criteria:

* Cases: History of Papillary, Follicular, Follicular Variant of Papillary, or Hurthle cell thyroid cancer (both active disease and in remission).
* Controls: Individuals with a thyroid nodule, matched to cases for age, BMI, season of vitamin D measurement.
* Participating in University of Nebraska Medical Center Thyroid Tumor and Cancer Collaborative Registry database.

Exclusion Criteria:

* Pregnant or breast feeding women
* Medullary thyroid cancer
* Anaplastic thyroid cancer
Study to Determine the Effect of Efavirenz on the ECG QTcF Interval in Healthy Subjects

The purpose of this study is to determine whether multiple doses of Efavirenz has an effect on the QTc interval (corrected by Fridericia) in CYP2B6 \*1/\*6 and \*6/\*6 healthy subjects.

CYP = Cytochrome p-450

Primary Purpose: Other: This is a Phase 1 clinical pharmacology thorough QT study being conducted as a post marketing requirement

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy volunteers, ages 18 to 49 years old
* BMI 18 to 32 kg/m2
* Women must not be pregnant or breastfeeding

Exclusion Criteria:

* A personal history of clinically relevant cardiac disease, symptomatic or asymptomatic arrhythmias, presyncope or syncopal episodes, or additional risk factors for torsades de pointes (eg, heart failure)
* History of hypokalemia, personal history or family history of prolonged QT interval, or family history of sudden cardiac death at a young age
* Any of the following on 12-lead electrocardiogram (ECG) prior to study drug administration: PR ≥210 msec, QRS ≥120 msec, QT ≥500 msec, QTcF ≥450 msec, HR \<45 bpm
* Second or third degree heart block prior to study drug
* Positive urine screen for drugs of abuse
* Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or Human Immunodeficiency Virus (HIV)-1, -2 antibody
* Any of the following lab results outside of the ranges specified below prior to dosing: Alanine aminotransferase (ALT) \>upper limit of normal (ULN), aspartate aminotransferase (AST) \>ULN, Total bilirubin \>ULN, Direct bilirubin \>ULN, Creatinine \>ULN, Serum potassium \<lower limit of normal (LLN), Serum magnesium \<LLN
* History of allergy to Moxifloxacin, Efavirenz or related compounds
Retrolaminar Block Versus Tab Block in Abdomioasty

The aim of the study is to compare the analgesic efficacy of Us guided retrolaminar block versus transversus abdominis plane block in patient under going abdominal plastic surgery

Pain from intra abdominal surgery is a combination of somatic and visceral pain visceral pain transmitted by autonomic nervous system via sympathetic fibers from plexuses in close proximity to the viscera them selves Regional anesthetic are commonly used to prevent or minimize these side effect the use of ultra sound nerve block are commonly use as apart of multimodal post operative analgesia The tab block is used to decrease the need of post operative analgesia in patient undergoing abdominal plastic surgery It was found an alternative approach to para vertebral block the retro laminar block is performed with us guided imaging to reduce pain post operative and need analgesia

Eligibility Criteria:
Inclusion Criteria:

- 90patients aged 18/65years of both sexes and asa physical status one two and three undergoing abdominal plastic surgery

Exclusion Criteria:

* patient refusal Patient taking analgesia of chronic illness or have history of substance abuse Patient who are unable to describe their post operative pain Patient with history of coagulabathy Un cooperative patient Patient with known allergy to study drug Patient with infection at site needle puncture Patient with decompensated hepatic renal respiratory or cardiac disorder
Aqueous Vs Alcohol Chlorhexidine Skin Preparation for Prevention of Cesarean Section Wound Infections

This will be a single-center randomized control trial comparing the efficacy of two different formulations of Chlorhexidine surgical skin preparation in preventing cesarean section wound infections. Participants will be randomized to either 4% Chlorhexidine Gluconate aqueous solution (CHG) or 2% Chlorhexidine with isopropyl alcohol (CHG-IPA) 70% to examine the risk of infectious morbidity in those undergoing cesarean delivery. There will also be a cost-effectiveness analysis of the two preoperative skin preparations.


Eligibility Criteria:
Inclusion Criteria:

* Women undergoing cesarean delivery at Magee Women's Hospital

Exclusion Criteria:

* Inability to obtain consent (language barrier, emergency cesarean section etc.)
* Allergy to chlorhexidine or alcohol
* Chorioamnionitis
* Emergency cesareans where cannot wait for chlorhexidine alcohol to dry
* bowel injury at time of cesarean section
* Women who are delivered at another institution and are transferred postpartum to Magees Women's Hospital
The Impact of Hormonal Contraceptive Use and Lifestyle Factors on Fracture Risk and Bone Quality in Young Female Adults

The study on hand is based on a cross-sectional design and aims to acquire 1) descriptive data on the physical state and health condition of female soldiers in the German armed forces. 2) a possible influence of different contraceptive methods as well as physical activity, body composition, strength, nutrition, and hemoglobin levels on bone health should be investigated.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 35 years
* female
* willing to participate under a pseudonym
* occupational soldiers
* free from chronic or acute musculoskeletal injury

Exclusion Criteria:

* for the bioelectrical impedance: electronic implants like defibrillator, pregnancy
Effect of Repaglinide Versus Metformin Treatment in Non-Obese Patients With Type-2-Diabetes

Aim:

The United Kingdom Prospective Diabetes Study (UKPDS) showed a reduction in cardiovascular events in obese patients with type-2-diabetes treated with metformin compared with other hypoglycaemic treatments with no difference in glycemic control between treatments. Non-obese patients with type-2-diabetes are usually treated with insulin-secretagogues or insulin when diet fails. Since non-obese patients with type-2-diabetes also carry a high risk of cardiovascular events, the use of metformin for this sub-group of patients might be more beneficial. Moreover, when insulin-treatment is initiated ongoing oral hypoglycaemic agents (OHA) are often continued, but in non-obese patients with type-2 diabetes little evidence exist for choosing the optimal class of OHA to be combined with insulin. The aim of the project is therefore to investigate the effect of metformin vs. an insulin-secretagogue (repaglinide) in combination with insulin on glycemic control and non-glycemic cardiovascular risk-factors in non-obese patients with type-2-diabetes, uncontrolled on diet alone.

Methodology:

Single-center, double-blind, double-dummy, randomized, parallel study involving 100 non-obese (BMI 27 kg/m2 or lower) patients with type-2-diabetes investigating the effect of treatment with metformin vs. repaglinide each in combination with biphasic insulin (Insulin-aspart 30/70, BIAsp30) for a period of 12 months.

After four months run-in with repaglinide plus metformin combination-therapy, patients with HemoglobinA1c ≥6.5% will be randomized (baseline=0 month) to repaglinide 2 mg thrice-daily or metformin 1g twice-daily, both in combination with BIAsp30 (30% insulin-aspart; 70% protaminated insulin-aspart) (6U once-daily, pre-dinner) for 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Non-obese patients (BMI \< 27 kg/m2)
* Type 2 diabetes
* Age 40 years or older
* HbA1c = 6.5% or higher at baseline.

Exclusion Criteria:

* No known contraindications for either of the study-drugs (known allergy to the study-drugs; heart-, liver- or kidney-failure)
* Pregnancy
* Other serious physical or mental illnesses with a life-shortening prognosis.
* Drug or alcohol abuse.
* Weight-loss of more than 5 kg during the last 6 month prior to enrollment.
Comparing the Extent to Which Three Different Formulations of LY4100511 (DC-853) Are Made Available in the Body, Alone and in the Presence of a Drug That Reduces Stomach Acid

The main purpose of this study is to compare the bioavailability of 3 different formulations of LY4100511 and if the use of a proton pump inhibitor (PPI) alters the bioavailability of the 3 different formulations.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 18.0 and 32.0 kilograms per meter squared (kg/m2), inclusive, and a body weight of ≥50 kg.
* In good health, as determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG) and vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[e.g., suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable) at screening and check-in, and from the physical examination at check-in, as assessed by the Investigator (or designee).

Exclusion Criteria:

* Have a 12-lead ECG abnormality that, in the opinion of the Investigator,

  * increases the risk associated with participating in the study
  * may confound ECG data analysis
  * a QTcF: \>450 millisecond (msec) for males, or \>470 msec for females
  * short PR interval \<120 msec or PR interval \>220 msec
  * second or third degree atrioventricular block
  * intraventricular conduction delay with QRS \>120 msec
  * complete right bundle branch block
  * left bundle branch block, or
  * Wolff Parkinson-White syndrome
* Have a current or recent acute, active infection (for example, for a least 30 days before screening and up to Day -1, participants must have no symptoms or signs of infection in the absence of any anti-infective treatment).
* Had any malignancy within the past 5 years. Exceptions: successfully treated basal cell skin carcinoma or squamous cell skin carcinoma, with no evidence of recurrence or metastatic disease within the 3 years prior to baseline.
* Have inflammatory bowel disease (IBD), including ulcerative colitis or Crohn's disease.