cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetic Study of Aprepitant in BEP Treatment of Patients With Testis Carcinoma (A-BEP)

The purpose of the study is to investigate whether there is an interaction occurs between etoposide and aprepitant in patients with testis carcinoma treated with the standard BEP regimen.

Also to determine how long treatment with aprepitant is necessary in BEP regimen for 5 consecutive days.

Aprepitant is a novel, potent and selective nonpeptide neurokinin-1 receptor antagonist that was licensed in 2004 for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy.More recently the indication for use of aprepitant was extended to patients with moderately emetogenic chemotherapy. Based on experience with the use of aprepitant it appears rational to consider aprepitant as part of the anti-emetic regimen for patients treated with BEP. There are, however, no published data available for the use of aprepitant in this situation.

Eligibility Criteria:
Inclusion Criteria:

* between 18 and 75 years of age
* able and willing to sign Informed Consent Form
* subject has an indication for treatment with BEP regimen
* subject is expected to receive at least 2 cycles of BEP regimen
* subject is able to swallow capsules

Exclusion Criteria:

* documented history of sensitivity/idiosyncrasy to aprepitant or excipients
* relevant history or condition that might interfere with drug absorption
* history of or current abuse of drugs, alcohol or solvents
* inability to understand nature and extent of the trial and the procedures
* participation in a drug trial within 30 days prior to the first dose
* febrile illness within 3 days before the first dose
* use of agents that are known to interfere with aprepitant pharmacokinetics
* abnormal liver or renal function
Application of Ultrasound Artificial Intelligence and Elastography in Differential Diagnosis of Breast Nodules

The application of computer-aided diagnosis (CAD) technology "S-Detect" enables qualitative and quantitative automated analysis of ultrasound images to obtain objective, repeatable and more accurate diagnostic results. The Elastic Contrast Index (ECI) technique, unlike conventional strain-elastic imaging techniques, can evaluate the elastic distribution in the region of interest. The purpose of the study was to evaluate the differential diagnosis value of ultrasound S-Detect technology for benign and malignant breast nodules and evaluate the differential diagnosis consistency of the ultrasound S-Detect technique and the examiner for benign and malignant breast nodules and explore the differential diagnosis value of Samsung ultrasound elastic contrast Index (ECI) technique for benign and malignant breast nodules.

Breast cancer is the most common malignancy in women and the second leading cause of cancer deaths worldwide. Therefore, early detection of breast cancer and timely treatment are of great significance for controlling and reducing breast cancer mortality. Breast ultrasound is an adjunct to extensive use in the detection of breast cancer, but ultrasound is highly technically dependent on the examiner, and the results are greatly influenced by the subjective nature of the examiner, adding unnecessary surgery and puncture, which causes great problems for clinicians and patients.Moreover, the value of conventional ultrasound in the differential diagnosis of breast mass is still limited, and the emergence of new technologies such as artificial intelligence and elastography has improved the accuracy of ultrasound diagnosis to varying degrees.

S-Detect technology is a computer-aided (CAD) system recently developed by Samsung Medical Center for breast ultrasound to assist in morphological analysis based on the Breast Imaging Reporting and Data System (BI-RADS) description and final assessment.This provides a new way to identify the benign and malignant breast nodules.

The E-Breast technique, unlike conventional strain-elastic imaging technology, performs an elastic analysis of the entire two-dimensional image.Moreover, when measuring the elastic ratio, it is only necessary to place a region of interest (ROI) at the nodule.Compared with the average elasticity of the surrounding area, it is more reflective of the elastic ratio of the mass to the surrounding tissue.

Eligibility Criteria:
Inclusion Criteria:

1. Had breast lesions detected by ultrasound
2. Age 18 or older
3. Upcoming FNAB or surgery
4. Signing informed consent

Exclusion Criteria:

1. Patients who had received a biopsy of breast lesion before the ultrasound examination
2. Can not cooperate with the test operation
3. Patients who were pregnant or lactating
4. Patients who were undergoing neoadjuvant treatment.
Use of Oxygen Hoods in Patients Failing on Conventional High-flow Oxygen Delivery Systems, Effects on Oxygenation in Hypoxic COVID-19 Patients. Prospective Cohort Study.

To determine whether the use of oxygen hoods as compared to conventional high-flow oxygen delivery systems, and the effects on oxygenation, mechanical ventilation and mortality rates in hypoxic patients with COVID-19.

To determine whether Oxygen hoods improve O2-saturation (SaO2), and how they effect length of hospitalization, and in-hospital mechanical ventilation and mortality rates in Covid-19 patients when compared to conventional high-flow oxygen delivery systems. Oxy-hemoglobin saturation is continuously measured by pulse-oximetry including immediately before and after oxygen hood placement, and will be measured in controls.

Comparison/Control Group The control cohort includes COVID-19 patients presenting for treatment prior to 4/3/20 when hyperbaric oxygen hoods were not available. Patients maintained on, or those failing on conventional O2- delivery systems and subsequently receiving mechanical ventilation will be studied.

All patients included must have tested positive using PCR swabs and/or been diagnosed based on clinical/laboratory standard diagnostic criteria. Medical management will include evolving treatment regimens and other standard medical treatments widely used at time of study in all hypoxic COVID-19 patients.

Prognostic/confounding covariates are to be collected through Electronic Medical Record (EMR) chart review and compared between intervention and control cohorts. including: Age, Body Mass Index (BMI), Gender, Chronic Lung disease - COPD, Asthma (CLD), cardiovascular disease - CAD, CHF, Chronic Dysrhythmia (CVD), chronic kidney disease (CKD), Immunosuppression - History of Cancer, Immunosuppressive medication, HIV (Immunosuppression), Diabetes Mellitus (DM), and pertinent lab markers.

Routine follow-up evaluation is maintained until final in-hospital outcomes are known including:

1. Oxygen Difference pre/post-hood (SaO2 difference, %)
2. Intubation/MV status (Intubated)
3. Survival/Mortality (Expired)
4. Hospital Length of Stay (LOS, days)

Randomization/Blinding Randomization is not possible as it is unethical to deny a hypoxic patient an alternative approved means of oxygenation for patients failing on conventional oxygen delivery systems. No blinding of participants or investigators.

Eligibility Criteria:
Inclusion Criteria

* Hospital census is reviewed for ALL patients seen in the Emergency Department admitted with COVID -19 diagnosis and experiencing hypoxia requiring supplemental high-flow oxygen delivery or who have required mechanical ventilation.
* Consent (native language services provided).
* No limitations/restrictions on age, sex, race/ethnicity, comorbidities, pregnancy status, DNR/DNI status.

Exclusion Criteria

* SaO2 \> 90% on conventional high-flow O2-delivery system.
* Confinement anxiety post-oxygen hood placement with request for removal.
Treatment Strategy for Alcohol Use Disorders in Veterans With TBI

The purpose of this research study is to understand the effectiveness of valproate (a common mood stabilizer) to further reduce alcohol misuse when given in addition to attending an alcohol rehabilitation program as well as the treatment of mood disorders or PTSD. The main goal of this project is to understand if people receiving valproate will have a better recovery than people receiving the standard treatment for alcohol dependence: naltrexone.

Veterans are vulnerable to develop complex forms of addictive disorders characterized by the presence of traumatic brain injury and psychiatric conditions such as post-traumatic stress disorder and mood disturbances. Alcohol use disorders are frequently observed among veterans and exert a detrimental effect on community reintegration after deployment. Attending to this veteran health problem, the VA is devoting extraordinary efforts to develop adequate treatment strategies. In this study we will evaluate treatment outcomes and identify specific factors that influence alcohol use disorders treatment response in a VA Intensive Outpatient Program offering rehabilitation treatment to the growing number of veterans with alcohol use disorders. Cooperation between researchers and clinical staff will allow optimizing treatment strategies that enhance the recovery of veterans with alcohol use disorders.

Eligibility Criteria:
Inclusion Criteria:

* Veterans attending alcohol use disorders rehabilitation treatment within the VA
* Presence of a diagnosis of alcohol dependence according to DSM-IV
* A history of heavy drinking
* Absence of withdrawal symptoms

Exclusion Criteria:

* Evidence of other substance abuse different from nicotine or cannabis (DSM-IV criteria) or by 2 consecutive positive urine drug screens
* Unstable medical conditions such as severe heart disease, liver or renal failure or evidence of neoplasia.
* Liver Enzymes (ALT, AST) serum levels \>3 times the upper limit of normal
* Unstable psychiatric conditions that requires treatment in a more structured setting (i.e. active SI, worsening psychotic symptoms or acute mania)
* Diagnosis of schizophrenia or schizoaffective disorder
* Requiring therapy with valproate or naltrexone or has a history of significant side effects from either study drug
* Requiring therapy with topiramate, lamotrigine or carbamazepine
* Requiring chronic treatment with opioid analgesics for refractory pain
* Failed 3 previous intensive alcohol rehabilitation programs in the past 2 years
* Females
Detection and Biopsy Guidance of Nasopharyngeal Carcinoma Based on Artificial Intelligence and Endoscopic Images

Due to the occult anatomic location of the nasopharynx and frequent presence of adenoid hyperplasia, the positive rate for nasopharyngeal carcinoma identification during biopsy is low, thus leading to delayed or missed diagnosis for nasopharyngeal carcinoma upon initial attempt. Here, we aimed to develop an artificial intelligence tool to detect nasopharyngeal malignancies and guide biopsy under endoscopic examination based on deep learning.

Due to the occult anatomic location of the nasopharynx and frequent presence of adenoid hyperplasia, the positive rate for nasopharyngeal carcinoma identification during biopsy is low, thus leading to delayed or missed diagnosis for nasopharyngeal carcinoma upon initial attempt. Here, we aimed to develop an artificial intelligence tool to detect nasopharyngeal malignancies and guide biopsy under endoscopic examination based on deep learning.

Eligibility Criteria:
Inclusion Criteria:

* The patient was found to have a nasopharyngeal lesion through the nasopharyngeal endoscopy and the clinicans considered it necessary to perform an biopsy.
* Hemilateral lesion with limited size.

Exclusion Criteria:

* Patients with nasopharyngeal cancer, oropharyngeal cancer, hypopharyngeal cancer, etc. who have already been treated.
Propiverine in Children Suffering From Non-Neurogenic Overactive Bladder and Urinary Incontinence

The study was conducted between 2004 and 2006 to prove efficacy and tolerability of the antimuscarinic propiverine compared to placebo in children suffering from non-neurogenic overactive bladder and urinary incontinence.

This clinical trial showed superior efficacy of propiverine over placebo and convincing tolerability for the treatment of children suffering from OAB and urinary incontinence.

Eligibility Criteria:
Inclusion Criteria:

* voiding frequency 8 or above per day
* at least one incontinence episode per day
* age between 5-10 years
* body weight between 17 and 45 kg

Exclusion Criteria:

* normal age expected bladder capacity
* PVR more than 10 ml
* dysfunctional voiding
* neurogenic disorders
* UTI, constipation
SSRI Effects on Semen Parameters in Men

According to the National Institute of Mental Health, depressive disorders afflict over six million U.S. men annually. Most cases of moderate or severe depression are treated with antidepressants, including monoamine oxidase inhibitors, tricyclic antidepressants, and, more recently, selective serotonin reuptake inhibitors (SSRIs) and antidepressants with modest serotonin and norepinephrine reuptake inhibition but unknown mechanism-of-action. Over the past two years, prescribing data show a steady increase in antidepressant dispensing rates (especially including serotonin reuptake inhibitors) for adults. SSRIs are known to have an effect on ejaculatory function and are therapeutically used for treatment of premature (rapid) ejaculation. However, few studies have evaluated the potential impact of antidepressant medications on male fertility, and no studies have been published with respect to the impact of newer antidepressants, such as SSRIs, on male fertility. In the high-volume male infertility practice at New York Hospital-Cornell Medical Center, several patients have presented who have had a clear temporal association between SSRI use and impairment in sperm motility and/or sperm transport (emission). These men have shown improvement in sperm counts and motility after discontinuation of antidepressant medications.

We propose a crossover pilot study of normal healthy males to ascertain possible effects of SSRIs on semen parameters. After initial screening semen analyses, subjects will take the SSRI paroxetine for five weeks. Serial semen analyses will be obtained while on medication and one month after discontinuation of medication. Comparisons between semen parameters on and off medication will be used to evaluate the frequency and significance of semen analysis changes during SSRI treatment.

Eligibility Criteria:
Inclusion Criteria:

* Normal, healthy male volunteers, ages 18-65
* Must be able to swallow pills

Exclusion Criteria:

* Known sexual dysfunction
* Tobacco use
* Prescription medications
* History of psychiatric disorders
* Previous chemotherapy or radiation treatment
* History of seizure disorder
* Alcohol use greater than 2 ounces daily
* Illicit drug use
* Azoospermia on screening semen analysis
* Varicocele
* Currently attempting to achieve pregnancy
Effects of Cannabis on Prescription Drug Abuse Liability and Analgesia

The purpose of this research is to assess the impact of cannabis on the analgesic and abuse-liability effects of a sub-threshold dose of a commonly used analgesic.


Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant female aged 21-53 years
* Previous cannabis use
* Previous opioid use
* Urine test positive for recent cannabis use
* Being able to perform all study procedures
* Currently practicing an effective form of birth control (women only)

Exclusion Criteria:

* Meeting criteria for some Use Disorders
* Report regular illicit drug use
* If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process revealed any significant illness
Awake Prone Positioning for Severe Acute Chest Syndrome

Acute chest syndrome (ACS) is the leading cause of admission to intensive care and the leading cause of death in patients with sickle cell disease. Irrespective of the cause of ACS, there is an heterogeneity in pulmonary ventilation/perfusion ratios, leading to worsening of the disease.

Efficiency of awake prone positioning (APP) in acute respiratory failure (ARF) was particularly highlighted during the COVID-19 pandemic. Several physiological factors contribute to this benefit including an improvement in ventilatory drive and gas exchange.

The investigator hypothesize that APP could lead to clinical improvement in ACS in terms of oxygenation and ventilatory drive, by improving the heterogeneity of ventilation

* Several physiological mechanisms contribute to the benefit of APP during ARF. In addition to hypoxemia improvement, there is also an effect on ventilatory drive, notably in terms of polypnea, ROX index and inspiratory effort.
* Considering that hypoxemia in ACS contributes to the physiopathological process: deoxygenation of haemoglobin S - red blood cells falciformisation - vaso-occlusive event, APP could be an additional therapy in severe ACS. In addition, improving ventilation-perfusion ratios, mainly by recruiting dorsal zones, could be particularly useful in ACS, where pulmonary damage predominates in gravito-dependent zones.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Major sickle cell anemia (SS, SC, Sβ)
* Admission in intensive care unit for ACS
* Registered in the French social insurance regime.
* Written, informed consent

Exclusion Criteria:

* Pregnant or breastfeeding women
* Immediate need for intubation
* Impaired vigilance status (Glasgow scale score \< 12)
* Pneumothorax
* Haemodynamically unstable
* Thoracic trauma admission
* Severely obese with body-mass index higher than 40 kg/m²
* EIT contraindication: pacemaker, automatic implantable defibrillators, skin lesions facing the EIT belt, unstable rachis fracture or medullary lesions
Preterm Labor Prediction by Cervical Contour in Ultrasound

Cervical length is a already known predictor for preterm labor. In this study the investigators want to examining the hypothesis that cervical curvature is also a predictor for preterm labor and that moderate transducer pressure influence cervical length.

study population: 200 consecutive pregnant women between 14-34w, visiting in the ultrasound unit ether for routine screening or because of preterm labor.

During their examination cervical length and curvature measurements will be taken. Another measurement will be taken after applying moderate cervical pressure.

The investigators will compere cervical contour and pressure influence between groups and according to cervical length Demographic data will be taken at the time of recruitment and pregnancy outcome measures in a later telephone interview.


Eligibility Criteria:
Inclusion Criteria:

* pregnancy

Exclusion Criteria:

* cervical cerclage
* pre term rupture on membrane in current pregnancy
* unknown dating of pregnancy
Gastrointestinal Microbiome Study of Appendiceal Cancer

This study analyzes the gastrointestinal microbiome of appendiceal cancer patients with peritoneal spread scheduled to undergo cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC). Participants will provide fecal samples pre- and post-operatively.

Analysis of the human microbiome is an attempt to define how changes in the human microbiome are associated with health or disease.

Eligible participants scheduled to undergo cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) for appendiceal cancer will provide fecal samples pre- and post-operatively. Investigators will analyze potential changes in the gastrointestinal microbiome and make comparisons to an age-matched healthy sample.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of appendiceal cancer with peritoneal spread
* Candidate for cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC)
* ≥18 and ≤ 80 years of age
* Eastern Cooperative Oncology Group performance status score of ≤2/Karnofsky performance status (KPS) ≥70%
* Signed Institutional Review Board approved informed consent

Exclusion Criteria:

* \<18 years of age
* Pregnant women
* Concurrent severe medical problems unrelated to malignancy
Comparison Of Outcome Of Microneedling With Autologous PRP Vs Microneedling With Topical Insulin In Treatment Of Post Acne Atrophic Scars.

Microneedling with topical INSULIN is a simple, effective tool for building body's new collagen layers and thus an alternative to all erosive techniques such as lasers, peels. The skin responds to fine punctures with the release of growth factors. 8 It is a safe procedure that can be performed in the office without complications, with a good cost-benefit because it is economically viable without any effect on patient's daily activities. 9


Eligibility Criteria:
Inclusion Criteria:

* postacne atrophic scars ≥ 2 on Goodman and Baron's acne scar-grading system
* Either gender.
* Age 20-50 years.

Exclusion Criteria:

* lactation and pregnancy
* skin cancers and infection
* photosensitivity like SLE ,XP
* use of RETINOIDS in last 6 months.
Percutaneous Cryoablation of Intercostal Nerves for the Treatment of Rib Fractures

The goal of this double blinded randomized control trial is to learn if percutaneous cryoablation of traumatic rib fractures improves outcomes. The main questions it aims to answer are:

Does percutaneous cryoablation improve short and long term pain scores? Does percutaneous cryoablation improve short and long term respiratory mechanics? Does percutaneous cryoablation improve long term quality of life? Does percutaneous cryoablation decrease delirium?

Researchers will compare cryoablation to standard multimodal pain therapy to see if this impacts respiratory recovery.

Participants will undergo randomization, percutaneous cryoablative procedure, and participate in tests at pre-determined intervals to evaluate their pulmonary recovery.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* \> 2 rib fractures
* Verbal Pain score \> 5
* Incentive Spirometry \< 60% of predicted

Exclusion Criteria:

* Isolated Fractures of Ribs 1-3 and/or 10-12
* Posterior Rib Fracture \< 4 cm from costovertebral joint
* Sternal, Clavicle, Scapula Fracture
* Thoracic Spinal Fracture of any type
* Open Abdominothoracic Surgery
* Unstable Spine
* Extensive Subcutaneous Emphysema
* BMI \> 35
* Plan for Rib Plating
* Chronic Opioid Use
* Prior to study enrollment: Intubated, Traumatic Brain Injury, Dementia, Cognitive Impairment, Encephalopathy
* Coagulopathy, Shock at time of ablation
* Inability to participate in activities of daily living prior to injury
* Home O2 use prior to trauma
* Inhalation Injury
* Rib Fractures due to cardiopulmonary resuscitation
* Life Expectancy \< 6 months
* \> 48 hours from injury
* Pregnant, Incarcerated