cyrilzakka/clinical-trials huggingface dataset:
Can Biomarkers Aid in the Prediction of Postoperative Pain and Circulatory Instability After Major Abdominal Surgery?

Patients undergoing major surgery are exposed to extensive damage of tissues, which induces widespread activation of the inflammatory system, called 'systemic inflammatory response syndrome' (SIRS).This activation of the inflammatory system may induce instability of the heart and respiration in the postoperative period. The degree of physiologic response to postoperative SIRS as well as the degree of postoperative pain differ between patients. Therefore, patients undergoing anesthesia and major surgery are treated in a 'post anesthesia care unit' (PACU) after end of surgery.Admittance to a PACU is expensive. The time patients need to stay in a PACU after major surgery has not been extensively studied, and more appropriate tools for prediction of length of stay are needed.

The main aim of this study is to assess whether clinical observations, inflammatory biomarkers or genetic markers may aid in the prediction of physiological instability and/or pain after major surgery. Such predictors would help clinicians planning the length of PACU-stays.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing major abdominal surgery (e.g. Whipple's operation, liver resection, abdominoperineal resection, vascular abdominal surgery etc.)
* Scheduled for PACU stay first 24 hours

Exclusion Criteria:

* Pregnancy
* Jehovah's witness
* Dementia
Gastrointestinal Myoelectric Activity Protocol, the G-Tech EEnG Protocol

A feasibility study for monitoring and recording gastrointestinal (GI) myoelectric activity in subjects with suspected or diagnosed irritable bowel syndrome (IBS) and reports of GI pain and asymptomatic subjects without IBS and GI pain.

This single arm, prospectively enrolling, non-randomized feasibility study has been designed to transcutaneously detect and monitor myoelectric intestinal signals temporally associated with the symptoms of patients who report pain and have suspected or diagnosed IBS, and in controls \[subjects without suspected IBS or diagnosis of IBS and prior and/or current complaints of pain\].

Eligibility Criteria:
General Eligibility Criteria:

General Inclusion Criteria

* Willing and able to provide informed consent;
* Eighteen (18) years of age or older;
* Willing and able to follow a specified study procedure regimen;
* No known allergy to commercially available food or drink required by specified study procedure regimen;
* Willing and able to recline and remain still during the recordings.

General Exclusion Criteria

* Subject has an implantable device such as a pacemaker, defibrillator, nerve stimulator, insulin pump, automatic analgesic pump, or other automated implanted medical device;
* Known allergy to isopropyl (rubbing) alcohol;
* Known allergy to Ag/AgCl electrodes;
* Known allergy to glue adhesive (electrode adhesive);
* Dietary restrictions not permitting intake of food or drink required by this protocol;
* Dietary restrictions not permitting four (4) hour fasting period prior to start of myoelectric recording;
* Subject is pregnant or suspects pregnancy;
* Open sores or wounds on the abdomen;
* Any injury in or around the area of electrode placement that would cause pain with gentle pressure required for electrode and lead wire placement;
* Weight \> 300 lbs (136 Kg) (excess weight can interfere with quality of the signals).

IBS With Complaints of GI Pain Eligibility Criteria IBS With Complaints of Pain Inclusion Criteria All answers must be "YES" to the All of the Following Inclusion Criteria Prior diagnosis of IBS and complaints of GI pain IBS With Complaints of Pain Exclusion Criteria All answers must be "NO" to the All of the Following Exclusion Criteria Functional dyspepsia; No reports of GI pain, past or present.

Control Subjects Eligibility Criteria Subjects who do NOT have a prior diagnosis of functional GI disorder

Control Subjects Inclusion Criteria All answers must be "YES" to the All of the Following Inclusion Criteria

No prior diagnosis IBS; No complaints of GI pain.

Control Subjects Exclusion Criteria All answers must be "NO" to the All of the Following Exclusion Criteria Current diagnosis of any GI disorder; Current or recent complaints of GI pain.
The Characteristics of Prepulse Inhibition in Children and Adolescents Suffering From Attention Deficit Disorder

The purpose of this study is to show that Prepulse inhibition test of acoustic startle response is an indicator of objective diagnostic characteristics of attention deficit disorder in children and adolescents.

by demonstrating that Prepulse inhibition test of acoustic startle response is impaired in children and adolescents suffering from attention deficit disorder in the relation to the normal function described in the literature.

The investigators will try to prove our hypothesis by an experiment that consists of two phases:

Phase I (about 25 minutes):

The patient will enter the room, will be asked to sit on a chair, and will be asked to look at a computer screen showing silent video of aquarium fish, then the patient will be connected to both the Prepulse inhibition test device and the Galvanic skin response device and pass the tests.

Phase II (about 25 minutes):

After completion of Phase I, each participant will receive his daily regular dose of methylphenidate and after an hour and a half from taking the drug, will repeat the tests, both the Prepulse inhibition test and the Galvanic skin response test.

Duration of the entire experiment is 140 minutes (two hours and twenty minutes).


Eligibility Criteria:
Inclusion Criteria:

1. Between the ages of 7-18
2. Diagnosed with attention deficit hyperactivity disorder according to Diagnostic and statistical manual of mental disorders, fifth edition- Clinical diagnostic interview was performed.
3. Receive drug therapy with methylphenidate doses ranging from 0.3 mg / kg to 1 mg / kg.
4. The participant is treated with methylphenidate at least two months prior to the experiment.

Exclusion Criteria:

1. Autism.
2. Chronic neurological diseases.
3. Developmental delay.
4. Psychotic or major effective disorder (psychotic state now or in the past, schizophrenia, schizoaffective, depression, bipolar disorder)
5. Substance abuse.
6. Mental retardation.
7. Contraindicated for the treatment of methylphenidate.
8. Hearing problems.
9. Pregnancy week 20 and thereafter
Heart and Ischemic STrOke Relationship studY

Although cardio-embolic etiology of ischemic stroke (IS) is largely respected, there is still no clear recommendation for routine complex cardiological examination in all IS patients. Using complex cardiological examination the investigators expect:

1. more accurate detection of patients with concomitant heart disease (cardiac rhythm disorder, valve disorders, acute coronary syndrome, cardiac thrombus and myxoma, atrial and ventricle septum defects)
2. higher number of etiologically determinated IS, which is crucial for accurate secondary prevention.

The investigators expect significant changes of biochemical parameters (NT pro B-type of natriuretic peptide, pro-atrial natriuretic peptide, creatinkinase MB, troponin T), inflammatory markers (interleukine 6, procalcitonin, high sensitive C-reactive protein), and coagulation parameters in patients with CE IS compared to other causes of IS.

Assessing the glomerular filtration of cystatin C, glycated haemoglobin and serum lipids and its correlation with prior medicament use will allow to evaluate the long-term compensation of arterial hypertension, diabetes mellitus and dyslipidemia in IS patients.

In addition to the above mentioned comprehensive cardiological examinations, 1- and 3-week ECG-Holter will be performed in subpopulation of patients old up to 50 years and with cryptogenic ischemic stroke in the period from 1st May 2013 to 31st December 2015. These patients will also fill in a special epidemiologic questionnaire. Anticipated enrollment in this substudy of HISTORY study is 40 - 80 patients.

In selected young cryptogenic stroke patients, a subcutaneous cardiac monitor was implanted for the detection of paroxysmal atrial fibrillation in the period from 1st January 2014 to 31st December 2015.

From 2016 in young ischemic stroke (IS) patients under 50 years, a standard perfusion/ventilation scintigraphy of lungs will be performed to exclude acute pulmonary embolization (coincidental) in case of elevated serum D-dimers after admission.

In all enrolled young IS patients, a BP Holter will be performed after the discharge home to exclude possible arterial hypertension, which did not presented during hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic stroke admitted within 12 hours from stroke onset at stroke center

Exclusion Criteria:

* none
Effect of Caloric Restriction and Protein Intake on Metabolism and Anabolic Sensitivity

The purpose of this study is to determine if an increased protein intake can attenuate the suppression of metabolic and anabolic hormones during caloric restriction

1. Preliminary testing

   Prior to the study start, participants will be weighed and body composition will be determined using calipermetry (7 sites) and bioelectrical impedance. Peak oxygen uptake (VO2peak) will be assessed using an incremental exercise test on a bicycle ergometer.
2. Randomization

   Participants will proceed through each of the following conditions lasting 5 days:

   CR-LP: Participants will be restricted to 30 kcal/kg FFM/day and protein intake will be low (0.8 g/kg BW/day).

   CR-HP: Participants will be restricted to 30 kcal/kg FFM/day and protein intake will be high (1.7 g/kg BW/day).

   CON: Participants will be in energy balance and consume 1.7 g protein/kg BW/day.
3. Diet Prescription

   Dietary energy intake will be controlled using clinical products and maltodextrin to meet target energy intakes. Participants will received calcium and Vitamin D supplementation throughout the study.
4. Exercise Prescription

   During all conditions, participants will conduct daily supervised exercise on a bicycle ergometer at an exercise intensity of 60% VO2peak. Exercise duration will be adjusted individually such that exercise energy expenditure will amount to 15 kcal/kg FFM/day. Additional exercise and intense physical activity will be prohibited.
5. Assessments

   The following assessments will be conducted prior to the start of each condition as well as upon completion of each condition: body weight and composition (impedance), fasting blood draw for assessment of metabolic and anabolic hormones, resting metabolic rate, aerobic fitness (VO2peak), and questionnaires.
6. Washout

Once a participant has completed a study condition, participant will be allowed a washout of at least 14 days to allow protein balance to return to baseline (Hoffer \& Forse, 1990). During this time, participants will resume their regular diet and physical activity.

Eligibility Criteria:
Inclusion Criteria:

* 4 hours/week of purposeful aerobic exercise over the last 3 months
* Body mass index: 19-25 kg/m2
* \< 15% body fat

Exclusion Criteria:

* Cardiovascular disease risk factors that would result in greater than low risk
* Smoking
* Type I, type II diabetes, or history of high fasting glucose;
* History of high blood pressure and/or use of medication for hypertension;
* History of Dyslipidemia, or on lipid-lowering medication;
* Underlying health condition and/or use of medication that could interfere with any of our study outcomes.
* History or current diagnosis of a clinical eating disorder
* Failure to adhere to study protocol
A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

The primary purpose of the study is to assess how well amivantamab subcutaneous (SC) administration in combination with lazertinib or in combination with chemotherapy works (antitumor activity) in participants with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC; that is one of the major types of lung cancer).


Eligibility Criteria:
Inclusion Criteria:

* Have histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) that is not amenable to curative intent therapy
* Epidermal growth factor resistance-mutation (EGFRm) must be an Ex19del or Ex21 L858R substitution, as detected by food and drug administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA)-certified laboratory in accordance with site standard of care
* Have at least 1 measurable lesion, according to RECIST version (v)1.1, that has not been previously irradiated
* Any toxicities from prior systemic anticancer therapy must have resolved to national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0 grade 1 or baseline level (except for alopecia \[any grade\], grade \<=2 peripheral neuropathy, or grade \<=2 hypothyroidism stable on hormone replacement)
* Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1

Exclusion Criteria:

* Medical history of active interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis
* Had major surgery excluding placement of vascular access or tumor biopsy or had significant traumatic injury within 4 weeks before the first dose of anticancer treatments or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
* Participant has uncontrolled tumor-related pain (symptomatic lesions amenable to palliative radiotherapy should be treated prior to first dosing)
* Received an investigational treatment that has not been cleared (based on at least 5 half lives of any pharmaceutical treatment) or within 12 months before the planned first dose of study treatment or is currently enrolled in an investigational study
* Has a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s)
Open-Label Trial of Atomoxetine to Evaluate Academic Outcome in Children Ages 8-11 Years With Attention Deficit/Hyperactivity Disorder

Open-label trial of Atomoxetine to Evaluate Academic Outcome in Children Ages 8-11 years with Attention- Deficit/Hyperactivity Disorder


Eligibility Criteria:
Inclusion Criteria:

-Patients must have ADHD, be psychotropic medication naive and be outpatients who are at least 8 years of age and not more than 10 years of age at Visit 1 (that is, not yet reached their 11 birthday) so that all year testing will be completed before the child reaches age 12.

Exclusion Criteria:

-Patients with current or past history of Bipolar I or II disorder, psychosis, autism, Asperger's syndrome, pervasive developmental disorder, conduct disorder, seizure disorder or serious suicidal risk are excluded
Prospective Study of Video-assisted Rib Planting in Chest Wall Stabilization

The purpose of this study is to compare the advantages and disadvantages of video-assisted rib planting and traditional internal fixation of rib fractures in chest wall stabilization.

The investigators design a new surgical method of video-assisted thoracoscopic surgery for rib fractures, evaluate the advantages and disadvantages of the new surgical techniques with a prospective study.


Eligibility Criteria:
Inclusion Criteria:

-≥3 unilateral rib displacement fractures

* 18-70 years old
* ASA score I-II
* Preoperative arterial oxygen partial pressure \>60mmHg
* Carbon dioxide partial pressure \<50mmHg

Exclusion Criteria:

* The distance from the broken end of the posterior rib fracture to the spine is less than 2cm
* Airway stenosis
* Abnormal coagulation system
* History of peptic ulcer or bleeding
* History of allergy to anesthesia related drugs
* History of asthma or chronic obstructive pulmonary emphysema
* Pregnant women
Exercise and Motor Learning After Stroke (Study #3)

Subjects with chronic stroke (\> 6 months post-stroke) will learn a new walking pattern through distorted visual feedback. Retention of the pattern will be tested without visual feedback immediately after learning and 24 hours later. Subjects will be randomly assigned to the control group or the exercise group. The control group will simply complete the learning task. The exercise group will complete 5 minutes of exercise immediately following the first retention test to test for the effects of exercise on retention 24 hours later.

Despite significant time and money spent on post-stroke rehabilitation, stroke survivors are left with reduced walking capacity and significant disability. After stroke, individuals must relearn movements that have been disrupted due to damage to the brain, therefore, enhancing motor learning is critical to improving the rehabilitation of walking after stroke. In this project investigators will examine how individual factors influence motor learning after stroke and use this information to personalize post-stroke rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

Age 18-85 Single, unilateral, chronic stroke (\>6 months post-stroke), confirmed by MRI or CT scan Score \>1 on question 1b and \>0 on question 1c of the NIH Stroke Scale Able to walk at self-selected speed without assistance from another person Resting heart rate between 40-100 beats per minute Resting blood pressure between 90/60 to 185/100

Exclusion Criteria:

Evidence of cerebellar stroke on clinical MRI or CT scan, because of role of cerebellum in learning Other neurologic conditions in addition to stroke Inability to walk outside the home prior to the stroke Coronary artery bypass graft or myocardial infarction within past 3 months, Musculoskeletal pain that limits walking Inability to communicate with investigators Visual field cut Neglect Unexplained dizziness in last 6 months
Safety, Efficacy and PK of BIVV001 in Pediatric Patients With Hemophilia A

Primary Objective:

- To evaluate the safety of BIVV001 in previously treated pediatric participants with hemophilia A.

Secondary Objectives:

* To evaluate the efficacy of BIVV001 as a prophylaxis treatment.
* To evaluate the efficacy of BIVV001 in the treatment of bleeding episodes.
* To evaluate BIVV001 consumption for prevention and treatment of bleeding episodes.
* To evaluate the effect of BIVV001 prophylaxis on joint health outcomes.
* To evaluate the effect of BIVV001 prophylaxis on Quality of Life (QoL) outcomes.
* To evaluate the efficacy of BIVV001 for perioperative management.
* To evaluate the safety and tolerability of BIVV001 treatment.
* To assess the pharmacokinetics (PK) of BIVV001.

Study duration per participants was approximately 60 weeks (maximum 8 weeks for screening and 52 weeks of treatment).

All participants completing or remaining at the end of study were offered participation in the planned extension trial.

Eligibility Criteria:
Inclusion criteria :

* Participant must be younger than 12 years of age, at the time of signing the informed consent.
* Severe hemophilia A defined as \<1 international units per deciliter (IU/dL) (\<1 percent \[%\]) endogenous Factor VIII (FVIII) as documented either by central laboratory testing at Screening or in historical medical records from a clinical laboratory demonstrating \<1% FVIII coagulant activity (FVIII:C) or a documented genotype known to produce severe hemophilia A.
* Previous treatment for hemophilia A (prophylaxis or on-demand) with any recombinant and/or plasma-derived FVIII, or cryoprecipitate for at least 150 exposure days (EDs) for participants aged 6 to \<12 years and above 50 EDs for participants aged \<6 years.
* Weight above or equal to 10 kg.

Exclusion criteria:

* History of hypersensitivity or anaphylaxis associated with any FVIII product.
* History of a positive inhibitor (to FVIII) test defined as greater than or equal to (\>=) 0.6 Bethesda units (BU/mL), or any value greater than or equal to the lower sensitivity cut-off for laboratories with cut-offs for inhibitor detection between 0.7 and 1.0 BU/mL, or clinical signs or symptoms of decreased response to FVIII administrations. Family history of inhibitors would not exclude the participant.
* Positive inhibitor test result, defined as \>=0.6 BU/mL at Screening.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Cytokines and Cognitive Decline in Alzheimer's Disease

Amyloid plaques and neurofibrillary tangles are the 2 well-known etiopathological hallmarks of Alzheimer's disease (AD). Beside these 2 lesions, inflammation response is described in the brain of patients with AD.

The main objective of our study is to analyse the correlation between the value of plasma cytokines (interleukin 1, 6, TNFα and chemochine Rantes) and the rapidity of the cognitive decline in AD over a 2-year follow-up.

Secondary objectives include:

* the predictive value of the cytokines on the cognitive decline after 6 months and one year of follow-up., of the patients include 150 patients with AD (MMSE: 16-25)
* correlation between plasma cytokines levels and expression of the protein kinase PKR (involved in death cell) in blood mononuclear cells.


Eligibility Criteria:
Inclusion Criteria:

* Alzheimer's disease (AD)patients
* MMSE score: 16-25
* Written informed consent

Exclusion Criteria:

* AD patients with specific treatment for AD before inclusion MMSE score under 16 or over 25 at inclusion
* patients with anti-inflammatory drugs (non steroids or corticosteroids) or immunosuppressive agents
* Patients with acute disease (infectious disease, rheumatologic disease) or chronic disease (malignancy, infectious, rheumatologic disease) that could interact with plasma cytokines level
* Patients with a life threatening disease