cyrilzakka/clinical-trials huggingface dataset:
Diagnostic Test for Endometrial Receptivity 24 Hours Before Embryo Transfer

This clinical validation study is being carried out to validate the efficacy of a test measuring the clinical application of prostaglandins present in the endometrial fluid in patients, 24 hours before the embryonic transfer. This test is capable of predicting endometrial receptivity without the need of performing a biopsy.


Eligibility Criteria:
Inclusion Criteria:

* Any IVF patient being treated for single or double embryo transfer
* BMI: 20 - 30
* Normal ovarian response (7 - 8 ovocitos) in IVF treatment with AFC ≥ 8, (AFC = Antral Follicle Count)
* Elective embryo transfer
* Normal uterine cavity
* Age: ≤ 38 years old for patients with own oocytes; ≤ 50 years old for patients with donated oocytes.

Exclusion Criteria:

* Patients with recurrent miscarriages ( ≥ 2 biochemical miscarriages; ≥ 2 clinical miscarriage)
* Patients with severe male factor ( ≥ 2\*106 espermatozoides/ml).
Study With Rituximab, Cyclophosphamide, Doxorubicin Liposomal (Myocet®), Vincristine, Prednisone, (R-COMP) to Treat Non-Hodgkin's Lymphoma

This is a multicenter study phase II, open-label for cardiopathic patients affected by Non-Hodgkin's lymphoma diffuse large B cell CD20 + grade IIIb follicular. The purpose is to study the feasibility of R-COMP in this cohort of patients.


Eligibility Criteria:
Inclusion Criteria:

* NHL histological diagnosis of diffuse large B cell CD20 + (de novo or shift from low-grade NHL if not pretreated), grade IIIb follicular NHL;
* Age \>= 18 years;
* Presence of at least 1 factor that defines the cardiopathy;
* Life expectancy \> 3 months;
* In the case of women of childbearing age absence of pregnancy at the beginning of the chemotherapy;
* Written informed consent.

Exclusion Criteria:

* Histology different from NHL diffuse large cell CD20 + or follicular IIIb
* Age \< 18 years
* Inability to sign informed consent;
* HIV positivity;
* Patients HBsAg positive;
* AST/ALT \> 2 times the standard;
* Bilirubin \> 2 times the standard;
* Creatinine \> 2.5 mg / dl;
* Location of CNS disease;
* Pregnancy ongoing;
* Damage to that organ or medical problems that could interfere with the therapy;
* Current uncontrolled infection;
* Senile dementia
Laparoscopic Bariatric Surgery: Two Regimens of Venous Thromboprophylaxis: Prospective Randomized Study

Obese patients undergoing bariatric surgery warrant VTE prophylaxis because they are at high risk for developing a fatal pulmonary embolism or postthrombotic syndrome. However, a consensus does not exist on the most effective prophylactic approach.

Two regimens of prophylaxis are supposed , the 1st one is to give enoxaparin 40mg 2 hours before surgery and continued daily for 10 days after, and the 2nd one is to start 12 hours before surgery and continued in the same way like the 1st one.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>40 OR \>35 with comorbidities

Exclusion Criteria:

* No
Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System

The objective of this study is to demonstrate safety and effectiveness using a percutaneous Delivery System of the Laminar Left Atrial Appendage Closure System to treat patients with NVAF to reduce the risk of thromboembolism from the left atrial appendage (LAA).


Eligibility Criteria:
Inclusion Criteria:

* 1. Subject must have a documented history of paroxysmal, persistent or permanent nonvalvular atrial fibrillation (AF).
* 2. Subject must be ≥18 years of age.
* 3. Subject has a calculated CHA2DS2-VASc score of 2 or greater.
* 4. Subject must be clinically stable on warfarin (or other anticoagulant) therapy for a minimum of three months.
* 5. Subject must have at least two International Normalized Ratios (INRs); 2-3, if on Warfarin.
* 6. Subject is eligible for the defined protocol pharmacologic regimen of anticoagulation and antiplatelet therapy.

Exclusion Criteria:

* 1. Subject who requires anticoagulation for a condition other than AF.
* 2. Subject with a New York Heart Association (NYHA) classification equal to IV.
* 3. Subject with a history of or implanted atrial septal defect (ASD) device or patent foramen ovale (PFO) device that would interfere with the investigational device placement.
* 4. Subject with valvular disease.
Defining Volume Status in Sepsis with Extracellular Water Measurement

The goal of this observational study is to learn about the influence of extracellular water on volume status in adult sepsis patients presenting with hemodynamic instability. The main question it aims to answer is:

• Can measurement of extracellular water (MoistureMeterD, Delfin Technologies Ltd, Kuopio, Finland) contribute to the description of hemodynamic instability in adult sepsis patients.

Patients with sepsis admitted to intensive care will receive standard care with the addition of measurement of extracellular water.

Adult patients with sepsis admitted to any of our ICUs will be recruited. During the first three days after inclusion blood samples and extended non-invasive monitoring, including monitoring of the microcirculation (CytoCam) and measurement of extracellular water (dielectronic constant), will be added to routine care and monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Adults with sepsis.

Exclusion Criteria:

* Pregnancy, palliative care, other than sepsis known cause of shock.
Circumcision Versus Preputioplasty for BXO in Children

Traditionally, BXO is managed with circumcision (surgical removal of the foreskin) and this approach has long been held as the 'gold standard. Whilst this may be curative in many cases, it has been shown that 20% of boys require a further operative procedure on their penis to widen the urethral opening (to treat meatal stenosis)

An alternative to circumcision was proposed: a preputioplasty (surgery to widen the opening of the foreskin) was combined with injection of steroids into the affected foreskin. Subsequently, the same group compared the outcomes of this technique with circumcision, and reported circumcision was successfully avoided in 92% of the preputioplasty group. In addition, the rate of meatal stenosis (narrowing of the urethral opening requiring surgery) was significantly lower (6% vs 19%, P = .034 ). Preputioplasty may therefore: (i) offer protection against meatal stenosis and reduce the requirement for further surgery; and (ii) offer the benefit of retaining the foreskin, the function of which, while debated, likely includes sexual function. In view of these potential benefits, authors have called for a randomised trial to compare circumcision to preputioplasty and injection of steroids.

The interventions to be compared are operations to treat BXO called:

(i) circumcision: this will be a standard surgical circumcision whereby the prepuce (foreskin of the penis) is excised and the cut edge of the outer prepuce sutured to the cut edge of the inner prepuce. The two study team members performing the surgery in this trial (HC and SK) will be free to choose the method of circumcision (e.g. guillotine vs. sleeve) as this is not thought to influence outcome. The foreskin will be sent for histological analysis.

(ii) preputioplasty with intralesional injection of triamcinolone. Briefly, longitudinal incisions will be placed in the area of phimosis, and these will be sutured transversely to allow the prepuce to become retractile. A biopsy of an area of affected foreskin will be sent for histological analysis. The intention will be to perform three incisions (tri-radiate) but the final decision on how many will be made by the operating surgeon and based on the appearance of the prepuce and result of initial incision(s). Once the prepuce is felt to be freely retractile, 1 - 3 mL of triamcinolone (Adcortyl Bristol-Myers Squibb 10 mg/mL) will be injected intradermally around the circumference of the affected foreskin using a 25-gauge needle.

These procedures are established treatments for BXO and currently in use by the trial surgeons in the same setting as the trial.The preputioplasty with injection of triamcinolone procedure has previously been approved by the Alder Hey Children's Hospital NHS Trust Clinical Development Evaluation Group (CDEG).

Eligibility Criteria:
Inclusion Criteria:

* aged between 2 and 16 years
* diagnosed with BXO
* require surgery to treat BXO

Exclusion Criteria:

* previous penile surgery
* circumcision or preputioplasty medically contraindicated
Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2020_09

Participants will perform two different listening tasks: (1) listening to, and repeating back, sentence lists presented in noise, and (2) Subjective rating of effort \& performance following each condition. During this study, continuous, non-invasive physiological measurements (skin conductance, changes in pupil dilation) will be recorded from participants. Using this paradigm we will be assessing the effect of different hearing aid processing algorithms on listening effort. The study takes the form of a one factor (algorithm), within-subjects design.

Each participant performs the Speech perception task with each algorithm (reference, noise reduction I, noise reduction II, noise reduction III), at two individualized signal-to-noise ratios (SRT90 and SRT50). Additionally subjective performance ratings in real-life will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Healthy outer ear (without previous surgical procedures)
* Ability to fill in a questionnaire conscientiously
* Informed Consent as documented by signature
* Minimum 1 year hearing aid experience
* Moderate-Severe (N3-N5) hearing loss or Normal Hearing

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments
* Inability to produce a reliable hearing test result
* Massively limited dexterity
* Known psychological problems
* Known central hearing disorders
Evaluation of Safety and Pharmacokinetics of Single Doses of VBY-376 in Healthy Adults

The study will evaluate the safety and pharmacokinetics of single doses of VBY-376 in healthy subjects.

Single dose escalation study of 5 dose levels of VBY-376. Eight subjects per group will receive one dose of VBY-376 then have multiple blood draws for pharmacokinetic evaluation and followed for safety with laboratory evaluations, ECG's, vital signs, and adverse events. Safety data will be reviewed before proceeding to the next dose.

Eligibility Criteria:
Inclusion Criteria:

* males and females between 18 and 45 years of age
* screening body mass index between 20 and 29 kg/m2
* in good health with no clinically significant medical conditions
* able to comprehend and willing to sign an informed consent

Exclusion Criteria:

* history of renal, hepatic impairment, stomach or intestinal surgery or resection, malabsorption syndrome
* anemia or blood donation within 8 weeks of check-in
* plasma donation within 4 weeks of check-in
* history of alcoholism or drug addiction within 1 year prior to check-in
* use of drugs of abuse
* no tobacco-containing products within 6 months of study
* participation of any clinical trial within 30 days
* history or presence of abnormal ECG
* no prescription or over-the-counter medications within 14 days of study and during the study
* history of Gilbert's syndrome
Serratus Anterior Plane Block for Management of Post Thoracotomy Pain

This is a single-center, randomized, prospective study evaluating the effect of serratus anterior plane block performed after induction of anesthesia, but before the start of surgery on postoperative opioid requirements. The hypothesis of the study is that serratus anterior plane blocks are relatively simple to perform, provide good postoperative analgesia, facilitate early tracheal extubation, and reduce the length of hospital stay after pediatric cardiac surgery through a thoracotomy.

This is a single-center, randomized, prospective study evaluating the effect of serratus anterior plane block performed after induction of anesthesia, but before the start of surgery on postoperative opioid requirements. There is already a postoperative protocol for the management of pain in the pediatric cardiac intensive care unit. This protocol will be maintained so all patients will be receiving clinically accepted and standard postoperative pain management.

Routine preoperative evaluation will be performed to establish eligibility for study inclusion. All patients will receive anesthesia by a pediatric cardiac anesthesiologist according to the clinical protocol established for these patients. The serratus anterior plane block will be performed by a pediatric anesthesiologist on the acute pain service team who routinely perform pain blocks at this institution.

Group 1 will receive an ultra-sound guided serratus anterior block after induction of general anesthesia. Group 2 will not receive a serratus anterior block.

Postoperative pain will be managed by a pediatric cardiac intensivist according to a standard pain protocol.

Eligibility Criteria:
Inclusion Criteria:

* 12 months of age or less
* Infants undergoing cardiac surgery through a thoracotomy incision
* Infants having surgery performed by a Pediatric Cardiac Surgeon at Riley Hospital

Exclusion Criteria:

* Infants requiring sternotomy or emergency surgery
* Allergy to local anesthetics
* Neonates less that 37 weeks gestation
* Infants intubated prior to surgery
* Infection at the site of the Serratus Anterior Plane Block 6. Bleeding diathesis with increased risk of hematoma at the block site 7. Allergy to morphine 8. Active pulmonary infection
The Relationship of Psychological Factors and Sleep Quality With the Severity of Carpal Tunnel Syndrome

The most common entrapment neuropathy symptoms, the diagnosis of CTS, is determined by examination findings and by means of the results of electro-diagnostic test. With an increase in disease severity, trap neuropathy, whose symptoms are more pronounced at night, negatively affects the daily life of the person. Deterioration in sleep quality may cause depression and anxiety. Conflicting results have been found in the studies related to these findings. However, no study was found in which daytime sleepiness was evaluated in terms of CTS. The investigators aim in this study is to evaluate the relationship between CTS severity and depression, anxiety, sleep quality and daytime sleepiness.

Carpal tunnel syndrome (CTS) is the most common peripheral neuropathy with an incidence of 2.7-4%. CTS, resulting from compression of the median nerve in the wrist, clinically progresses with tingling, numbness matching the nerve trace, and motor deficit in the presence of progressive nerve damage. Accordingly, the incidence of neuropathic pain is increasing. In addition to these symptoms mentioned, electro-diagnostic tests are used for diagnostic purposes and to determine the severity of nerve compression, and as a result, there are different types of classification, but most commonly CTS is classified as mild, moderate and severe. This classification is of great importance for the regulation of the follow-up and treatment protocol and making the association of existing complaints with the disease. Studies have shown that approximately 80% of CTS patients wake up at night due to numbness in the hand, resulting in deterioration in sleep quality. Impairment of sleep quality may cause increased sympathetic nervous system activity and awakening of physical and psychological stressors. Deterioration in sleep quality may cause depression and anxiety. Conflicting results have been found in the studies related to these findings. However, no study was found in which daytime sleepiness was evaluated in terms of CTS. The investigators aim in this study is to evaluate the relationship between CTS severity and depression, anxiety, sleep quality and daytime sleepiness. This study;149 patients with a diagnosis of CTS were prospectively included in the study. Electro-diagnostic test results were used to determine the severity of the disease. In this context, Boston CTS rating scale was used to evaluate the functional and symptomatic effects, Pittsburgh sleep quality scale and Epworth sleepiness scale were used to evaluate sleep quality and daytime sleepiness, and pain DETECT questionnaire was used to evaluate pain type.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-75 years diagnosed with CTS.
* Patients who were mentally able to respond to the assessment questionnaires were also included

Exclusion Criteria:

* Clinical diagnosis of cervical radiculopathy/plexopathy findings
* Pregnancy
* Diabetes mellitus
* thyroid diseases
* amyloidosis
* collagen tissue diseases
* Obstructive sleep apnea
* History of the upper extremity trauma
A Clinical Trial to Evaluate Pharmacokinetics and Safety Between DWC20151 and DWC20152

A randomized, open-labeled, oral dose, crossover design clinical trial to evaluate pharmacokinetics and safety between DWC20151 and DWC20152 in healthy male subjects.

This study is to evaluate pharmacokinetics and safety between DWC20151 and DWC20152 in healthy male subjects.

Study design is randomized, open-labeled, oral dose, crossover design. This study will conducted with 2 separated part (Part A, Part B).

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects (18\~55 years)

Exclusion Criteria:

* Who has allergy to investigational product
The Effect of Exenatide on Fasting Bile Acids

Newly diagnosed T2DM participants without hypoglycemic drugs intake were retrospective analyzed. Plasma total bile acids in fasting state (FTBAs) and other parameters were compared before and after exenatide treatment and correlation analysis between changes of FTBAs and glycemic parameters.

Newly diagnosed T2DM participants without hypoglycemic drugs intake were retrospective analyzed. Plasma total bile acids in fasting state (FTBAs) and other parameters were tested at baseline. Then exenatide were applied to the T2DM participants for 12 weeks. FTBAs and glycemic parameters were measured again after exenatide treatment, and correlation analysis between changes of FTBAs and glycemic parameters were conducted to investigate the role of BAs in the glycemic control effect of exenatide.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed T2DM patients

Exclusion Criteria:

* History of hepatobiliary or pancreatic diseases
* History of anti-diabetic drugs intake
* Change of anti-dyslipidemia therapy regimen
* Estimated glomerular filtration rate less than 60 mL/min/1.73 m\^2
* Pregnancy
Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain

The objectives of the study are to 1) Conduct telemetric biosignals (EDA, ECG, and EMG) recording in healthy controls and IBS participants experiencing cutaneous and visceral pain; and 2) Validate the OIME index as a biomarker for quantifying pain in IBS participants and its capability to assess the treatment of IBS pain via an ambulatory trial.

In part 1, data collection for training the OIME model, we will collect autonomic and muscular activities with integrated biosignal device and visceral pain level in both healthy controls and IBS participants. These data will be used to train a machine learning model to produce an objective integrated multimodal electrophysiological (OIME) index.

In part 2, the ambulatory trial, we will collect data to validate the OIME index as a biomarker of pain in IBS participants. We will run an ambulatory trial to validate the OIME index as a biomarker to assess the treatment of IBS pain.

Eligibility Criteria:
Inclusion Criteria:

* Participants need to be diagnosed with IBS by a healthcare provider according to Rome-III or -IV criteria, with a current report of abdominal pain.
* Men and women 18-50 years old
* Able to read and speak English
* Daily access to a computer with internet access.

Exclusion Criteria:

* Other chronic pains that are usually not comorbid with IBS, e.g., diabetic neuropathy, myofascial pain, low back pain, peripheral neuropathy etc.
* Celiac disease or inflammatory bowel disease
* Diabetes mellitus; d) Serious mental health conditions
* Women during pregnancy or within 3 months post-partum period
* Self- reported Regular use of opioids or other illicit substances.
* Participants who have had COVID-19 should be fully recovered, and will be asked if their medical provider has made any restriction on activities.
Study Examining PrEP-001 in Subjects With Asthma

Phase 2 study, to examine the prophylactic efficacy, safety and tolerability of PrEP-001 in asthmatics who have been infected with the human rhinovirus (HRV16) after receiving two doses of the study drug/placebo.

Screening took place up to 90 days before quarantine, where volunteers were asked to complete an informed consent and undergo scheduled screening assessments to determine their eligibility.

Eligible volunteers were invited to test and record their respiratory symptoms and peak expiratory flow (PEF), medications and any adverse events in diary cards from Day -14 to Day -5.

They attended Quarantine on Day -4/-3, received the study drug/placebo intra nasally on Day -2 and Day -1 and subsequently challenged with HRV16 on Day 0. Randomisation to receive study drug/placebo was 1:1.

Volunteers remained in the quarantine unit for 8 days after inoculation.

PEF self-testing continued from Day 9 to Day 28.

On Day 20 (±3 days) and Day 28 (±5 days), volunteers attended follow up visits where they were assessed by a study physician for well-being, on-going symptoms and adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 55 years on the day of first dosing with IMP.
* Physician diagnosed asthma for at least 6 months prior to Screening and using treatment equivalent up to and including Global Initiative for Asthma (GINA) Stage 3.
* In good health with no history of major medical conditions (other than asthma) that will interfere with subject safety, as defined by medical history, physical examination, and routine laboratory tests as determined by the Investigator at a screening evaluation.

Exclusion Criteria:

* Any ex-smoker or smoker with a history of more than 10 pack-years.
* History of life-threatening asthma, Diagnosis of COPD as defined by the current Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2014 guidelines.
* Any history or evidence of any clinically significant medical and psychiatric conditions