cyrilzakka/clinical-trials huggingface dataset:
Neonatal Pulse Oximetry Compared With Apgar Scores

Apgar score is a subjective measure to assess prognosis and future outcome of a newborn. Pulse oximetry taken at 1, 5 and 10 minutes will be correlated to apgar scores in respective times in an goal to assess the usability of pulse oximetry as an added tool in determining the newborn prognosis


Eligibility Criteria:
Inclusion Criteria:

Newborns delivered vaginaly or by C-section at Kern Medical Center labor and delivery ward

Exclusion Criteria:

known cardiopulmonary disease of the newborn
Workplace Intervention: Activity Monitoring as a Tool for Corporate Wellness and Weight Loss

Is a one-year intervention with Treadmill Desks associated with increased employee daily physical activity and decreased sedentariness.

36 employees with sedentary jobs (87 + 27 kg, BMI 29 + 7 kg/m2) used a Treadmill Desk for one year. Daily Physical Activity, work performance, body composition, and blood variables were measured at Baseline and 6 and 12 months after the Treadmill Desk intervention.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will be recruited regardless of race/ethnicity.

Exclusion Criteria:

* Definite termination criteria.

  * Request by subject to leave study.
  * Evidence of deliberate non-compliance (e.g.; placing activity instruments on another individual, deliberate destruction of instruments).
  * Pregnancy.
  * Alcohol abuse; elicit drug abuse.
  * Development of chronic condition that is likely to impact on metabolic variables or requiring medications likely to impact on metabolic variables or likely to result in subject being unable to participate (e.g., Grave's disease, hypothyroidism, rheumatoid arthritis requiring steroids or limiting mobility, congestive cardiac failure, neurological disorder such as multiple sclerosis or stroke).
  * Development of acute condition that is likely to impact on metabolic variables or requiring medications likely to impact on metabolic variables or likely to result in subject being unable to participate (e.g., motor vehicle accident with multiple fractures, myocardial infarction, major depression).

Potential termination criteria.

Development of acute or chronic condition that may impact on metabolic variables or requiring medications likely to impact on metabolic variables or likely to result in subject being unable to participate. Subjects will be reviewed on a subject-by-subject basis and will be reported to the Safety-Monitoring Panel. Specific action plans are pre-assigned for:

* Diabetes (two fasting plasma glucose values \>126 mg/dl). Here, glycosylated hemoglobin will be measured three monthly (by the study) and subjects referred to their local physician for preventative screening. Subjects will be excluded from further study with any glycosylated hemoglobin value of \>8% or symptomatic hyperglycemia.
* Depression or low mood. Here, all patients will be asked to be evaluated by their primary care physician and if appropriate referred to a psychiatrist. The opinion of the psychiatrist will be used to determine continuance or termination in the protocol.

This does not represent a comprehensive listing of criteria or causes. All subjects who withdraw or whom are withdrawn from the study or whom are considering/being considered for withdrawal will be referred to the Safety-Monitoring Panel. These subjects' data will be scrutinized (whether terminated or not) separately to assess for association of intervention with a specific adverse outcome.
A Study to Evaluate the Effectiveness of Essure Post-NovaSure Radiofrequency Endometrial Ablation Procedure Following a Successful Essure Confirmation Test

The purpose of the post approval study is to evaluate the effectiveness and safety of the Essure System when a NovaSure Endometrial Ablation procedure is performed following a successful Essure Confirmation Test.

This study has previously been posted by Conceptus, Inc. After acquiring Conceptus, Inc., Bayer is now the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* All inclusion criteria from the Essure Permanent Birth Control System Instructions for Use and/or the NovaSure Impedance Controlled Endometrial Ablation (EA) System Instructions for Use and Controller Operator's Manual will apply.
* Women experiencing menorrhagia due to benign causes
* Women who are relying on the Essure micro-inserts for permanent contraception following a successful Essure Confirmation Test (as applicable to the Post Approval Study)
* Women willing to accept the risk of pregnancy while relying on the Essure micro-inserts for prevention of pregnancy following a NovaSure ablation procedure for menorrhagia

Exclusion Criteria:

* All exclusion criteria from the Essure Permanent Birth Control System Instructions for Use and/or the NovaSure Impedance Controlled Endometrial Ablation System Instructions for Use and Controller Operator's Manual will apply.
* Women who previously underwent a fallopian tube sterilization procedure (other than Essure placement)
* Women who present with any other medical complaints, conditions or symptoms unrelated to the Essure System and/or subsequent NovaSure EA including, but not limited to:

  * Gynecological co-morbidities (e.g., pelvic infection, cervicitis, undiagnosed vaginal bleeding, endometrial cancer, myomas, and polyps)
  * Reproductive tract anatomical variants and/or pathology which could make the subject unsuitable for the Essure and/or NovaSure transcervical procedures
* Women currently wearing an intrauterine device and unwilling to have it removed before NovaSure
Assessment of Physical Performance With A Supplementation Containing HMB in a Sample of Old Women in Good Health

The purpose of this study is to determine whether a supplementation containing β-Hydroxy-β-methylbutyrate is effective in the treatment of age-related muscle loss in a group of older women compared to a non interventional group


Eligibility Criteria:
Inclusion Criteria:

* People over 65 years, not residents in nursing home, in good health
* Mini Mental State Examination (corrected for scholarity) more than 23

Exclusion Criteria:

* Previous oral supplementation with proteins or minerals
* important co-mordidities, such renal or hepatic failure
OCS DCD Heart + CAP Continued Follow-Up

The objective of this post-approval study is to evaluate long-term outcomes of patients enrolled in the OCS DCD Heart and OCS DCD Heart CAP studies.


Eligibility Criteria:
Inclusion Criteria:

* Patients transplanted in the OCS DCD Heart Trial and OCS DCD Heart CAP trials.
The Effect of Intra-abdominal Pressure on Peritoneal Perfusion During Laparoscopic Colorectal Surgery

Peritoneal perfusion during laparoscopic surgery is quantified by video recording after intravenous injection of indocyanine green at a pneumoperitoneum pressure of 8, 12 and 16 mmHg.


Eligibility Criteria:
Inclusion Criteria:

* Adults (≥ 18 years old)
* Scheduled for robot-assisted colorectal laparoscopic surgery

Exclusion Criteria:

* Severe liver- or renal disease
* Pregnancy or lactation
* Planned diagnostics or treatment with radioactive iodine \< 1 week after surgery
* BMI \>35 kg/m2
* Known or suspected hypersensitivity to indocyanine green, sodium iodide or iodine
* Hyperthyroidism or thyroid adenomas
* Use of medication interfering with ICG absorption as listed in the summary of product characteristics.
Biochemical and Physiological Response to Stressogenic Stimuli

Post-traumatic stress disorder (PTSD) is characterized by physiological changes, some of which are thought to be chronic, while others are observed in response to stressogenic stimuli. A psychiatric diagnosis of PTSD is currently based mainly on non-quantitative elements, such as interviews and subjective impressions. Discernable patterns of stress-related measures may constitute a physiological and biochemical phenotype characteristic of PTSD, which may serve as a biomarker and support diagnostic decisions, as well as personalized treatment plans.

The current study is aimed at examining the possibility of basing a psychiatric diagnosis by measuring changes in the biochemical phenotype of participants with PTSD. Physiological and biochemical data will be collected from participants with and without PTSD using wearable sensors and adhesive biosensor patches. The data will be collected in two conditions: in a neutral, quiet situation, and during and following exposure to controlled stressogenic stimuli.


Eligibility Criteria:
Inclusion Criteria:

* PTSD diagnosis (excluding controls)
* Proper ability to give informed consent

Exclusion Criteria:

* Active oncological/cardiovascular condition
* Dialysis patients
* Active psychotic or suicidal symptoms
* Severe dissociative symptoms
* A traumatic brain injury (TBI) diagnosis
* Pregnancy
Valvosoft First-In-Human Study in Severe Symptomatic Aortic Stenosis

This is a prospective, controlled, single-arm clinical investigation for the treatment of subjects with severe symptomatic aortic valve stenosis using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-Human

CARDIAWAVE has developed a new non-invasive, real-time image-guided, therapeutic approach to treat patients suffering from Calcified Aortic Stenosis. CARDIAWAVE's Valvosoft device is a new ultrasound therapy based on a disruptive technology involving delivering an extremely precise and focused ultrasound beam to perform a reparative effect on the aortic valve leaflets, softening the valve's tissues, restoring leaflet mobility, and therefore improving the overall clinical status related to the aortic valve stenosis. In this study, a brai-MRI is performed before the procedure and 24-72 hours after the procedure to detect cerebrovascular events.This is a FIM study

Eligibility Criteria:
Inclusion Criteria:

* Subjects suffering from severe symptomatic aortic valve stenosis according to ESC 2017 definition, including subjects with a bicuspid valve.
* Patient is not eligible for TAVR/SAVR according to local Heart Team.
* Age ≥18 years.
* Subjects who are willing to provide a written informed consent prior to participating in the study.
* Subjects who can comply with the study follow up or other study requirements.
* Patient is eligible for the Valvosoft procedure according to CRC.

Exclusion Criteria:

* Subjects with any electrical device implanted.
* Subjects with unstable arrhythmia not controlled by medical treatment.
* Subjects with implanted mechanical valve in any position or bio prosthetic valve in aortic position.
* Subjects with complex congenital heart disease.
* Chest deformity.
* Cardiogenic shock.
* History of heart transplant.
* Subjects requiring other cardiac surgery procedures (bypass graft surgery, mitral valve procedure, tricuspid valve procedure) within one month after treatment.
* Thrombus in heart.
* Acute myocardial infarction (MI), stroke or transient ischemic attack (TIA) within one month prior to enrolment\*.
* Subjects who are pregnant or nursing.
* Subjects who are participating in another research study for which the primary endpoint has not been reached.
Atrioventricular Junction Ablation and Biventricular Pacing for Atrial Fibrillation and Heart Failure

There is evidence of superiority of AV junction ablation strategy over pharmacological therapy only for symptoms of atrial fibrillation, but not for heart failure, hospitalization, morbidity and mortality. Hypothesis of trial is that AV junction ablation is superior to pharmacological therapy as regard hospitalization and mortality

Prospective randomized, controlled, investigator-initiated trial which consists of two specific consecutive(overlapped) phases:

"Morbidity trial" (APAF-CRT morbidity). Small size (280 pts), follow-up 24 months. Primary endpoint: combined of mortality due to heartfailure, hospitalization for heart failure or atrial fibrillation or worsening heart failure. Predefined subgroup analysis for patients with ejection fraction ≤35% versus \>35%

"Mortality trial" (APAF-CRT mortality). Large size (pts included in morbidity trial plus additional \~1500 pts, long-term follow-up (at least 4 years). Primary endpoint: total mortality. Predefined subgroup analysis for patients with ejection fraction ≤35% versus \>35%

Eligibility Criteria:
Inclusion Criteria:

To be eligible, each patient must be in the following condition:

1. Permanent atrial fibrillation (\>6 months) which has been considered unsuitable for ablation or failed ablation
2. Narrow QRS ≤ 110 ms
3. Severely symptomatic (atrial fibrillation-related symptoms), refractory to drug therapy for rate control
4. At least one hospitalization related to atrial fibrillation and/or heart failure in the previous year (see definition below)

Exclusion Criteria:

1. New York Heart Association (NYHA) class IV and systolic blood pressure \<80 mmHg despite optimized therapy;
2. severe concomitant non-cardiac disease;
3. need for surgical intervention;
4. myocardial infarction within the previous 3 months;
5. previous implanted devices (PM/ICD/CRT)
Long-term Neurocognitive Sequelae of Subclinical Microembolization During Carotid Interventions

Microembolization is commonly associated with carotid artery stenting (CAS), but our understanding of subclinical microembolization is superficial. Through collaborative effects of multidisciplinary team-experts, novel approaches, and longitudinal evaluations, we hope to better understand the clinical significance and long-term cognitive effects of microemboli. This proposal may change our current clinical practice by providing a better outcome measure for carotid interventions and improving outcomes of CAS procedures through risk factor stratification. Our central hypothesis is that development of subclinical microemboli is associated with decline in cognitive function following CAS and that the risk of development of microemboli themselves is associated with patient- and procedure-related factors. We hope that this prospective study will help to clarify these important issues in the era of rapidly evolving percutaneous interventions.


Eligibility Criteria:
Inclusion Criteria:

* Patient is male or female \>40 yrs of age.
* Patient has occlusive extracranial carotid stenosis (≥70%)
* Patient is scheduled to undergo an endovascular intervention of a lesion in the extracranial carotid artery
* Patient agrees to voluntarily participate and signs an informed consent.
* Patient agrees to be available for follow-up and is able to participate in all study testing procedures.
* Patient has sufficient visual and auditory acuity for cognitive testing.

Exclusion Criteria:

* Patient is unable to safely and comfortably undergo magnetic resonance imaging procedures (e.g., claustrophobia, implanted medical devices that are MRI incompatible such as pacemaker, defibrillator, neural stimulator etc)
* Patient has an untreated or unsuccessfully controlled psychiatric disease (schizophrenia, bipolar disorder).
* Patient has prominent suicidal or homicidal ideation.
* Patient has acute illness or unstable chronic illness (e.g. uncontrolled hypertension, hepatic encephalopathy, portal hypertension, ascites, and esophageal varices, pancreatitis).
* Patient with a history of neurological (e.g., multiple sclerosis, seizure disorder, Parkinson's disease) or systemic illness affecting central nervous system function.
* Patient has prior closed head injury with ≥24 hours of amnesia.
* Patient is unable to understand or sign the informed consent.
The Effect of Fibrate Therapy in Two Patients With Neutral Lipid Storage Disease With Myopathy (NLSDM)

Neutral Lipid Storage Disease With Myopath (NLSDM) is a disease caused by a defect in the PNPLA2 gene encoding ATGL. Patients with NLSDM accumulate triglycerides and exhibit muscle weakness, cardiac failure and hepatosteatosis. Most of these patients die at young age due to cardiac failure. Not much is known about the underlying mechanisms, though recently it was discovered that PPAR activation in ATGL-/- mice was impaired leading to decreased mitochondrial function, lipid accumulation and cardiac failure resulting in death at young age. Activation of PPARs, by treatment with fibrates rescued the phenotype and reduced mortality rates in these mice. These findings may have a major impact for patients with NLSDM if these results can be translated to humans. Therefore, the investigators would like to evaluate the beneficial effects of fibrate treatment on muscle mitochondrial and cardiac function in patients with NLSDM.

Patients will be treated with fibrates during a period of 28 weeks. Baseline measurements will be performed prior to the study and after treatment. Cardiac and muscular lipid accumulation, cardiac function, mitochondrial function and insulin sensitivity will be assessed during these baseline measurements.


Eligibility Criteria:
Inclusion Criteria:

* suffering from NLSDM
Sexual Health on Antidepressants Through Physical Exercise

Preliminary findings from a trial in the investigators laboratory suggest that acute exercise may ameliorate deficits in sexual arousal associated with use of antidepressants. The goal of this project is to evaluate the real-world effectiveness of an exercise-based intervention for these side effects in a community-based sample. The investigators hypothesize that general exercise will help improve sexual functioning in women taking antidepressants, and that exercise immediately before sexual activity - that is, acute exercise - will have an additional beneficial effect above and beyond that of general exercise.


Eligibility Criteria:
Inclusion Criteria:

* female
* age 18 or older
* currently receiving a consistent dosage of escitalopram, citalopram, sertraline, desvenlafaxine, venlafaxine, or duloxetine
* currently sexually active
* willing and able to exercise
* experiencing regular menstrual cycles
* not currently pregnant and not intending to become pregnant during trial

Exclusion Criteria:

* currently taking more than one psychoactive medication
* factors indicating risk of cardiovascular activity, including acute or chronic cardiovascular illness, including clinically significant hypertension (defined as self-reported hypertension or "blood pressure greater than 140/90" or receiving medications designed to treat hypertension); recent chest pain; frequent or recurrent faint or dizzy spells; severe or untreated exercise-related asthma; or musculoskeletal illness or injury that would be expected to worsen with physical exercise. Additionally, women will be excluded if they are found to have any of the following as measured during the fitness assessment of the first session: a BMI over 40, waist circumference over 40 inches, waist-to-hip ratio of greater than 0.9, systolic blood pressure greater than 150 or diastolic pressure over 95, or resting heart rate over 90.
* factors associated with significant genital nerve damage, including: previous major pelvic surgery that may have caused nerve damage, including hysterectomy, vulvectomy, circumcision, colostomy, cystostomy, or serious bladder, rectal, or abdominal surgery; or neurological impairment due to diabetes, stroke, pelvic nerve damage secondary to trauma, cancer treatments, myasthenia gravis, multiple sclerosis or spinal cord damage.
* factors associated with non-normative endocrine function, including: perimenopausal or menopausal status, or \>1 missed menstrual period in the previous 6 months; or currently pregnant, breastfeeding, or having breastfed within the past 3 months; or reporting clinically significant untreated renal or endocrine disease
* untreated serious mental health conditions
* sexual aversion or distress due to history of unwanted sexual contact
Ovarian Tumor Organotypic Slices Cultures for functionAl Drug Testing and Therapy Response Prediction

Ex vivo organotypic tumor slice cultures (OTSC) have unique characteristics in terms of tissue processing time and the maintenance of original microenvironment. Moreover, drug screening has been successfully performed on OTSC in a clinically meaningful time window.

For these reasons, we designed a study to assess the feasibility of establishing OTSC in OC patients and the concordance between ex vivo sensitivity and in vivo treatment response. If proven effective and reliable, OTSC could be introduced into clinical practice as empirical predictor of patients' response to platinum.

Most patients with ovarian cancer (OC) present with advanced stage and severe symptoms. The standard of care is based on an association between surgery and platinum-based chemotherapy, to which targeted therapies have been added since 2014. Despite significantly improved outcomes, there are still 15-20% of patients resistant to platinum-based chemotherapy without many therapeutic options and poor prognosis. It is urgent to select this population thus limiting useless undesirable effects and exploring more effective therapeutic options before clinical conditions worsen. To date, there are no validated predictive markers of primary platinum refractory or resistant disease and traditional cancer models are currently incompatible with treatment time window in this clinical setting.

Among cancer models, ex vivo organotypic tumor slice cultures (OTSC) have unique characteristics in terms of tissue processing time and the maintenance of original microenvironment. Moreover, drug screening has been successfully performed on OTSC in a clinically meaningful time window.

For these reasons, we designed a study to assess the feasibility of establishing OTSC in OC patients and the concordance between ex vivo sensitivity and in vivo treatment response. If proven effective and reliable, OTSC could be introduced into clinical practice as empirical predictor of patients' response to platinum.

Eligibility Criteria:
Inclusion Criteria:

1. Preoperative clinical, serological and radiologic suspicion of International Federation of Gynecology and Obstetrics (FIGO) stage IIIC or greater ovarian, fallopian tube, or primary peritoneal cancer;
2. Age over 18 years;
3. Estimated life expectancy of at least 4 weeks;
4. Fagotti score (PIV) \> 8 or patients not considered operable in the first place for any reasons;
5. Histologic diagnoses of epithelial ovarian cancer at frozen section.

Exclusion Criteria:

1. Non- epithelial histology at frozen section;
2. Patients enrolled in other clinical trials.