cyrilzakka/clinical-trials huggingface dataset:
Post-Operative Impact of Nasogastric Tubes on Rates of Emesis in Infants Diagnosed With Pyloric Stenosis

The overall objective of this research study is to determine the effect of a pre-operatively placed nasogastric tube compared to no nasogastric tube, on post-operative emesis rates and postoperative length of stay in infants with a primary diagnosis of pyloric stenosis treated with pyloromyotomy. This study will also examine the feasibility data of the pilot data to develop estimates of treatment effect of a pre-operative nasogastric tube on post-operative rate of emesis and length of stay to be used to determine the sample size of the definitive trial.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female infant ≤ 6 months of age
2. Primary diagnosis of Pyloric Stenosis confirmed by ultrasound
3. Amendable to circumumbilical pyloromyotomy
4. Amendable to a minimum size 10 French nasogastric tube
5. Able to undergo general anesthesia
6. Parent or legal guardian able to give free and informed consent

Exclusion Criteria:

1. Contraindicated for circumumbilical pyloromyotomy
2. Contraindicated for a size 10 French nasogastric tube
3. Prematurity before 35 weeks' gestation
4. Bronchopulmonary dysplasia
5. Viral infection in the past 7 days
6. Cardiac malformation
7. Patent ductus arteriosis
8. Previous abdominal surgery
9. Concurrent surgical procedure scheduled
10. Parent or legal guardian unable to read, speak and understand English
11. Co-enrolled in a different interventional trial
Validity and Reliability Study of the Pain Indicator Behavior Scale-Brain Damage (ESCID-DC)

A multicentre observational study to validate the adaptation of the Pain Indicator Behavior Scale (ESCID) for patients with acquired Brain Damage (ESCID-DC), as a measuring instrument.

Non-commercial study. The study complies with the ethical principles of the Declaration of Helsinki, the recommendations of Good Clinical Practice (GCP) and current legislation.

The study has been approved with a favorable opinion by the CEIm of the Hospital Universitario 12 de Octubre.

Written consent will be requested from the participants and / or their relatives / representatives to participate in the study.

Eligibility Criteria:
Inclusion Criteria:

1. Age equal to or greater than 18 years.
2. Inability to communicate verbally or motor.
3. Have a artificial airway.
4. Informed consent of the family member or representative of the patient.

Exclusion Criteria:

1. Previous pathology of cognitive impairment.
2. Previous brain injury.
3. Previous psychiatric disorder.
4. Previous dementia.
5. Previous chronic substance abuse.
6. Previous chronic diabetics.
7. Previous spinal cord injury.
8. Previous severe polyneuropathy (diagnosed or suspected).
9. Confirmed diagnosis of brain death.
10. Continuous infusion of muscle relaxants and / or barbiturate coma.
11. Level of deep sedation (RASS -5).
The Medical College of Georgia PLAY Project: Exercise Dose and Insulin Sensitivity in Obese Children

The study is a behavioral clinical trial of aerobic exercise to determine dose-response effects on risk for type 2 diabetes, fatness, fitness, blood cholesterol levels, and other cardiovascular risk factors in overweight elementary schoolchildren.

The hypothesis is that the more exercise a child does, the more benefit he or she will gain in reducing the risk of diabetes and other cardiovascular diseases.

An ancillary study examined effects on cognition and achievement.

The study is a behavioral clinical trial of aerobic exercise to determine dose-response effects on insulin response to the oral glucose tolerance test, body composition, fitness, lipid profile, inflammation and other metabolic syndrome components in overweight elementary schoolchildren.

Blinded psychological assessments of cognition and achievement were obtained.

Eligibility Criteria:
Inclusion Criteria:

* Overweight, sedentary children
* Black or white race
* Attending specific schools in Augusta, GA area from which this study is recruiting

Exclusion Criteria:

* Unable to participate in testing or vigorous exercise program
* Diabetes
* Taking medication that would affect study results
* Sibling enrolled in project
Vestibular Consequences of Blast-related Mild Traumatic Brain Injury (TBI)

The purpose of this project is to determine the effects of mild traumatic brain injury and blast exposure on the inner ear balance and central nervous systems.

The goal of this project is to determine the effects of mild traumatic brain injury (mTBI) and blast exposure on the vestibular system and CNS. Dizziness and balance disorders are common symptoms associated with mTBI or head injury. Numerous studies have provided significant evidence that mTBI or head injury can cause damage to the vestibular system; however, most have limited the vestibular evaluation to assessment of horizontal semicircular canal function. Recently, methods have been developed to assess otolith function, and there is some evidence that head injury may affect the otolith organs to a greater degree than the semicircular canals.

mTBI has been called the signature condition of Veterans returning from Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF), and the cause is often related to blast exposure from improvised explosive devices, mortars or rocket-propelled grenades. Some investigators have presumed that dizziness and balance disorders following blast exposure are related to CNS damage caused by the TBI rather than the pressure wave from the blast injury. Thus, most research has focused on the vestibular consequences of TBI (or head injury), and there is limited data on the effects of blast exposure on vestibular function or balance. Recently, magnetic resonance imaging techniques have been developed that may allow for testing the assumption that the symptoms of dizziness or imbalance related to head injury or blast exposure are often due to central vestibular or CNS involvement.

Specific aims of this project are to determine the effect of mTBI and blast exposure on (1) peripheral vestibular system function (specifically, horizontal semicircular canal function, and otolith organ function), (2) central vestibular/CNS function, (3) postural stability, and (4) dizziness-related quality of life. Four subject groups will include Veterans complaining of dizziness/imbalance with (1) a history of blast exposure, (2) with mTBI, (3) with blast exposure and mTBI, and (4) a control group. Each subject will undergo tests of horizontal semicircular canal function (caloric and rotary chair), tests of otolith function (vestibular evoked myogenic potentials, subjective visual vertical), central vestibular function/CNS function (ocular motor tests, diffusion tensor and susceptibility weighting imaging), gait and balance testing, and the Dizziness Handicap Inventory.

Eligibility Criteria:
Inclusion Criteria:

* Complaint of dizziness and/or imbalance
* History of blast exposure
* Diagnosis of mild traumatic brain injury

Exclusion Criteria:

* Prior history of vestibular or neurological disorder
* Presence of internal metal
* Pregnancy
Acquired Resistant Mechanism of the First-generation EGFR TKIs

Patients with advanced non-small-cell lung cancer (NSCLC) harboring sensitive epithelial growth factor receptor (EGFR) mutations invariably develop acquired resistance to EGFR tyrosine kinase inhibitors (TKIs). Identification of actionable genetic mutations can be helpful for guiding the subsequent treatment. This study aimed to analyze the genetic profile of NSCLC harboring acquired resistance to the first-generation EGFR TKIs using next generation sequencing (NGS).


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven stage IIIB or IV non-small cell lung cancer
* patients harboring sensitive EGFR mutations and received first-generation EGFR-TKIs who developed acquired drug resistance
* patients who can provide pre-treatment (EGFR TKIs) tumor tissues
* patients with tumor lesions to be re-biopsy after drug resistance
* patients must sign an informed consent indicating that they are aware of the .investigational nature of the study in keeping with the policy of the hospital.

Exclusion Criteria:

* History of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
* patients with other systemic diseases
The Effect of Lipitor on Aortic Stenosis

The purpose of this study is to find out if an approved medicine that is used to lower cholesterol called Lipitor can slow or stop progressive narrowing of the aortic heart valve in patients with a condition called aortic stenosis. Patients who have aortic stenosis who volunteer for this study will take Lipitor for 2 years and will undergo a brief exam by a physician, labwork to measure cholesterol, and a routine heart ultrasound (sound picture of the heart) at the start of the study and every 6 months, stopping at 2 years.

This is a prospective, single-center study assessing the effect of atorvastatin 40 mg/day (Lipitor, Pfizer) on the progression of calcific aortic stenosis in approximately 70 patients with mild to moderate calcific AS of a tricuspid or bicuspid aortic valve. As a control population, published data on historical AS cohorts will be used, employing the accepted rate of progression of a decrease in aortic valve area of 0.1 cm²/year. Additionally, also for comparison, we will prospectively study a registry of AS patients who meet our entry criteria but are either currently already being treated with or refuse to take an HMG-CoA reductase inhibitor (referred to as the "standard care" group).

All patient visits, laboratory studies, and echocardiograms will be performed at the Cleveland Clinic Foundation in Cleveland, Ohio with the exception of the 12-week visit ALT measurement which may be done at the patient's local doctor's office and the results faxed to Imaging Research. The 12-week follow-up assessment may be completed over the phone to establish any change in patient status since baseline, study medication compliance, concomitant medication use and to ascertain whether or not the appropriate laboratory test was obtained. Over a 2-year period, assessments will be conducted at baseline, 6, 12, 18, and 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate calcific AS of a tricuspid or bicuspid aortic valve
* Echocardiographic derived mean pressure gradient \>10 mmHg and an aortic valve area of 0.9 to 1.7 cm2 by continuity equation.
* Laboratory evidence of LDL-c\>70 mg/dl within 12 months prior to recruitment.

Exclusion Criteria:

* Left ventricular ejection fraction \<50%
* Valvular area of 0.9 cm2 and a mean gradient \>30 mmHg
* Rheumatic heart disease
* \>Moderate (2+) aortic insufficiency
* Prior statin therapy to include: \>10 mg of atorvastatin (Lipitor) or \>20 mg of other HMG-CoA Reductase Inhibitors (statins)
* End-stage renal disease (ESRD)
* History of thoracic radiation
* Unable or unwilling to sign informed consent
* Unable to unwilling to return for follow-up
* Other clinically important renal, pulmonary, hepatic, neurological, endocrine, or hematological disorders, vasculitis, or any other situation or medical condition that, in the investigator's opinion, would make survival for the duration of the study unlikely, or would otherwise interfere with optimal participation in the study or produce a significant risk to the patient
* Severe pulmonary hypertension (\>55 mmHg)
Evaluation of Integrated Versus Parallel Connection for Renal Replacement Therapy in ECMO Patients

Extracorporeal membrane oxygenation (ECMO) is an extra-corporeal assistance used in case of respiratory or circulatory failure. In case of circulatory failure, ECMO is in the veno-arterial configuration (VA-ECMO). VA-ECMO patients are at high risk of developing acute kidney injury (AKI) and renal replacement therapy (RRT) may be needed in 50% of ECMO patients. Although the administration of RRT in ECMO patients has major implications, no specific recommendations are currently available. The 2020 Kidney Disease: Improving Global Outcomes (KDIGO) international conference identified the evaluation of RRT in these ECMO patients as a research priority.

In 2023, the two main configurations used to administer RRT in ECMO patients are an independent delivery on a separate vascular access (parallel connection) or an integration of the RRT machine directly into the ECMO circuit (integrated connection). The integrated connection may reduce infectious and bleeding complications associated with the use of a second vascular access. However, it can expose the hemofilter and circuit to excessive positive pressures that can trigger pressure alarms in the RRT machine and expose the patient to a theoretical risk of air embolism or hemolysis. Furthermore, there is currently no robust data comparing the hemofilter lifespan with the parallel or with the integrated connection, although the filter lifespan is a crucial parameter to assess the quality of the RRT delivery in the ICU. The investigators recently performed a survey of practices in this context of ECMO patients. The investigators found that both strategies (parallel and integrated connection) are widely used and can be seen as common patient care.

The hypothesis tested in this study is the following: when RRT is integrated to the ECMO circuit, the hemofilter lifespan is non inferior to the one when RRT is delivered on a separate vascular access. Only VA-ECMO patients will be enrolled in this trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 75 years of age
* Patient on VA-ECMO who requires the initiation of continuous RRT during VA-ECMO treatment
* Patient with a foreseeable length of stay in intensive care greater than 24 hours

Exclusion Criteria:

* Patient who does not have a vascular capital allowing for the insertion of a new dialysis catheter to administer RRT and therefore cannot be randomized to the parallel connection group
* High pressures monitored on ECMO not allowing direct RRT catherter on ECMO
* Pregnant, parturient, or breastfeeding women
* Patient deprived of liberty by a judicial or administrative decision
* Patient under psychiatric care
* Patient subject to a legal protection measure (guardianship, curators)
* Patient not affiliated to a social security system
* Patient participating in another interventional research study in the field of extra purification renal
Satraplatin for Locally Advanced Non-Small Cell Lung Cancer With Simultaneous Radiotherapy

PURPOSE: This trial is designed to compare the combination of the investigational oral cytotoxic drug, satraplatin, and radiation therapy for patients with locally advanced Non-Small Cell Lung Cancer (NSCLC) with no prior chemotherapy or radiation therapy treatment. Please refer to the Eligibility Criteria below for key inclusion and exclusion criteria.

WHAT IS SATRAPLATIN: Satraplatin is an oral, investigational anticancer drug that is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally.

RATIONALE: Intravenously administered platinum-based drugs are currently used in combination with radiation therapy in the treatment of patients with locally advanced NSCLC. The purpose of this Phase I trial is to determine a tolerable dose and schedule for the oral platinum drug (satraplatin) when given to NSCLC patients throughout the course of their radiotherapy treatment.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or medically inoperable NSCLC (stage II or III)
* ECOG performance status score 0-2
* Adequate bone marrow, liver, and pulmonary functions
* Life expectancy \> three months.

Exclusion Criteria:

* Prior malignancy
* Serious concurrent uncontrolled medical disorder.
* Uncontrolled or significant cardiovascular disease
* History of mastectomy
* Pregnant or breast-feeding patients are not eligible
* Prior radiotherapy to the primary tumor site or cytotoxic chemotherapy
INVSENSOR00011 Clinical Performance Study

This study assesses the investigational sensor's (INVSENSOR00011) performance for detection of subjects' position and posture in bed, along with heart rate and respiratory rate.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 80 years old
* Physical status of ASA I or II
* Must be able to read and communicate in English
* Has signed all necessary related documents, e.g. written informed consent, health assessment questionnaire, gender and ethnicity form, confidentiality agreement
* Passed health assessment screening

Exclusion Criteria:

* Subject has any medical condition which in the judgement of the investigator, renders them inappropriate for participation in the study
* Inability to tolerate sitting still or minimal movement for at least 30 minutes
* Nursing female volunteers
* Excluded at the Principal Investigator's discretion
* Refusal to take pregnancy test (for female subjects)
* Positive pregnancy tests for female subjects of child bearing potential.
* Refusal to shave hair off areas where sensors will be applied (male subjects)
Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.

The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use.

The trial is an open-label safety and efficacy study of subjects with fibromyalgia who completed either study 06-008 or 06-009. Total duration is up to 40 weeks of trial participation.

Eligibility Criteria:
Inclusion Criteria:

* Subject has qualified for and completed either study 06-009 (NCT00423813) or 06-008 (NCT00371137).
* Subject is able, in the opinion of the investigator, to take Xyrem® for approximately 9-1/2 months.

Exclusion Criteria:

* Subject terminated early from either study 06-009 or 06-008.
* Subject experienced any serious adverse event related to study drug in either study 06-009 or 06-008.
* Subject, in the opinion of the investigator, experienced an adverse event in 06-009 or 06-008 that may prevent him/her from safely participating in this study.
Clinical Investigation to Evaluate the Tolerance of T10070 on Healthy Volunteers

The goal of this clinical trial investigation is to evaluate the tolerance of the T10070 on healthy volunteers by clinical examination under ophthalmological control.

Participants will attend 2 visits (inclusion at day 0 and follow-up/final at D7/D9. After inclusion, subjects will have to apply T10070 6 times a day during 7 to 9 days. The following tasks will be asked to participants:

* ophtalmological examination
* diary completion to record T10070 applications, potential discomfort/reactions observed and medication taken.
* complete subject questionnaire about usability of the product


Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed and dated
* Subject ≥ 18 years old
* Healthy volunteer
* Normal ocular examination in both eyes
* Normal skin examination in both eyes

Main Exclusion Criteria:

* Far best-corrected visual acuity (BCVA) ≥ +0.1 LogMar (e.g., ≤ 0.8 in decimal value or ≤ 80/100 Snellen equivalent)
* Known or suspected hypersensitivity to one of the components of the T10070
* History of trauma, infection, clinically significant inflammation within the 3 previous months
* Ongoing or know history of ocular allergy and/or uveitis and/or viral infection
* Diagnosed keratoconus
* Any palpebral abnormality
Aortic Stenosis Evaluated Via Modern Ballistocardiography and Seismocardiography

Calcific aortic stenosis (AS) (formerly "senile" or "degenerative") is a frequent disease of heart valves and is characterized by a thickness and calcification of leaflets with a significant increase of the pressure gradient, defined as an aortic jet velocity of \> 2 m/s. Whenever the aortic jet velocity is \> 4 m/s, in association with an aortic valve area of \< 1 cm2, the disease is classified as severe and cardiac outflow obstruction develops. AS affects 1-2% of population aged of \> 65 years and 12% of those aged \> 75 years. Among those aged \> 75 years, it is estimated that 3.5% has severe AS. With the aging of population, the prevalence of AS is expected to increase in the forthcoming years. Transcatheter Aortic Valve Implantation (TAVI) has been introduced in 2004 and consists in percutaneous replacement of the aortic valve. It is indicated in those patients with severe AS who cannot undergo surgical replacement because of high surgical risk. TAVI seems to be a good alternative to surgical intervention also for patients deemed at intermediate risk, especially if they are frail or aged. Ballistocardiography (BCG) consists of the measurement of the body's accelerations as a consequence of the recoil forces generated by the blood mass ejection at each cardiac contraction and recorded on the body's surface close to the subject's center of mass. Seismocardiography (SCG) records the heart-induced accelerations generated at each cardiac contraction and transmitted to the local chest surface. Thanks to specific algorithms applied to the SCG and BCG waves, it is possible to compute the kinetic energy (KE) and Power (P) of a single cardiac contractile cycle.

The aims of our study are to demonstrate that: LVOT Vmax and LVOT VTI changes obtained with echocardiography can be estimated reliably throught BCG and SCG signals, before and after TAVI procedure; Pmax and KE computed from the BCG and SCG signals could predict the severity of the AS before the TAVI procedure.

KE and P computed from non invasively recorded BCG and SCG waves may prove useful in the evaluation of AS severity and its evolution before and after TAVI procedure, respectively.


Eligibility Criteria:
Inclusion Criteria:

* Severe aortic stenosis, planned to undergo TAVI procedure

Exclusion Criteria:

* Concomitant heart valve disease other than AS
* C2 and D2 stages of AS according to the current definition (see table I for further details)
* Heart failure regardless to the etiology
* Arrhythmias
* Severe kidney disease
* Denied consent to participate
N-Force Screws Augmented With N-Force Blue in Hip Fractures

The objective of this prospective study is to confirm safety and performance of N-Force Screws augmented with N-Force Blue applied in intracapsular proximal femur fracture treatment.

Primary Endpoint:

• Re-operation within 12 months after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function.

Secondary Endpoints:

* Radiographic and clinical fracture healing of the proximal femur using standard scoring methods and patient satisfaction.
* Cost effectiveness

Eligibility Criteria:
Inclusion Criteria:

* Patient has primary Garden I or II intracapsular proximal femur fracture requiring surgical intervention and is eligible for fixation by three cannulated screws augmented with N-Force Blue.
* Patient receives operative treatment within 7 days of injury.
* Patient was ambulatory before injury.
* Patient is 50 years of age or older.

Exclusion Criteria:

* Patient has Garden III or IV intracapsular proximal femur fracture.
* Patient has major cognitive impairment (including dementia).
* Patient is on dialysis.
* Patient is not expected to survive follow-up schedule.
* Patient is expected to have problems maintaining follow-up compliance, i.e. patients with no fixed address, patients not mentally competent to give informed consent, etc. (Investigator's discretion).
* Patient is a prisoner.
* Patient is known to be pregnant and/or breastfeeding.
* Patient is a known alcohol or drug abuser.
* Patient had previous/has active acute or chronic infections, especially at the site of operation.
* Patient has non-viable bone, or has areas where surrounding bone is not viable or capable of supporting and anchoring the implant.
* Patient has traumatic injuries with open wounds or close to the proximal femur fracture, which are likely to become infected.
* Patient is expected to be non-compliant with recommended post-operative weight-bearing instructions.
* Physical conditions, in the opinion of the investigator, that would prohibit adequate implant support or impede healing.