cyrilzakka/clinical-trials huggingface dataset:
Markers in Follicular Fluid and in Embryo Culture Medium as a Marker of Oocyte and Embryo Quality

Assessment of the quality of follicular fluid and early embryo via chemical markers.

The selectin of an embryo for transfer is currently based on detailed morphological assessment and scoring system. morhpokinetics introduced recently to IVF laboratories can define annotations and provide an algorithm for optimal cleavage rates and embryonic development. however more data and validations are requested when it comes to choosing the best single embryo from a cohort of available similarly graded embryos. Consequently, non-invasive quantitative methods for embryo selection prior to transfer have been sought. In the current study metabolic profile of follicular fluid and the embryos produced in IVF procedure will be assessed

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing IVF procedures at Carmel Medical Center and are able to sign an informed consent form.
* Female patients age 18-45

Exclusion Criteria:

* Women with any malignancy
* Patient's request to be withdrawn from the study.
The Effect of Oral and Intravenous Ramosetron During Laparoscopic Cholecystectomy

Patients undergoing general anesthesia for laparoscopic cholecystectomy have a high risk of postoperative nausea and vomiting (PONV). The investigators investigated the effect of oral and IV ramosetron on PONV prophylaxis after laparoscopic cholecystectomy.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II patients, 25-65 years, electivelaparoscopic cholecystectomy under general anesthesia

Exclusion Criteria:

* GI disease, pregnant or menstruating, history of motion sickness and/or postoperative emesis, antiemetics within 24 h before surgery
Nano-crystalline Megestrol Acetate for Adjuvant Treatment in High-risk Head and Neck Squamous Cell Carcinoma After Surgery.

This study is a prospective, randomized, parallel-controlled clinical trial, with the primary objective to evaluate the efficacy and safety of nano-crystalline megestrol acetate combined with standard treatment compared to standard treatment alone for adjuvant therapy in patients with high-risk squamous cell carcinoma of the head and neck (excluding nasopharyngeal carcinoma) after surgery.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years at the time of enrollment.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
* Life expectancy ≥6 months.
* Patients with histologically or cytologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx, and hypopharynx).
* Patients who have undergone surgery for head and neck squamous cell carcinoma within 6 weeks and are assessed postoperatively as having high-risk factors requiring radiotherapy ± chemotherapy.

Exclusion Criteria:

* Suffering from tumors in areas other than the oral cavity, oropharynx, larynx, and hypopharynx, such as nasopharyngeal carcinoma or other unknown primary head and neck tumors.
* Having any condition that affects gastrointestinal absorption, such as dysphagia, malabsorption, or uncontrollable vomiting; currently undergoing tube feeding or parenteral nutrition.
* Suffering from anorexia due to neurosis, mental illness, or difficulty eating due to pain.
* Suffering from Acquired Immune Deficiency Syndrome (AIDS).
Influence of nCPAP on Metabolic Consequences Associated With OSAS

Context: Obstructive sleep apnea syndrome (OSAS) is associated with cardiovascular morbidity. Recurrent episodes of occlusion of upper airways during sleep result in hormonal changes that may predispose to high cardiovascular risk.These risks can rapidly be reduced by effective nasal continuous positive airway pressure (nCPAP) therapy Objective: To evaluate hypothalamic pituitary adrenal axis, insulin resistance, blood pressure values and adipokines in severe obese patients with and without OSAS and to determine if continuous positive airway pressure therapy (nCPAP) influenced responses.

Background: There is evidence that obstructive sleep apnea syndrome (OSAS) increases the risk of cardiovascular events. Sympathetic nervous system and hypothalamic-pituitary-adrenal (HPA) axis activation may be the mechanism of this relationship. We evaluate HPA axis and metabolic consequences in obese patients with and without OSAS and we determine if continuous positive airway pressure therapy (nCPAP) influenced responses.

Methods: Plasma inflammatory cytokines, insulin resistance index, 24-hour ambulatory blood pressure monitoring and overnight cortisol suppression test with 0.25 mg of dexamethasone were performed in 22 severe obese patients with OSAS and 23 obese controls. Ten patients with severe apnea were re-evaluated three months after nCPAP therapy.

Results: Body mass index, abdominal circumference, blood pressure levels and insulin resistance indexes of OSAS patients and obese controls were very similar. In OSAS patients, adiponectin (p\<0.05) and salivary cortisol suppression pos DEX (p\<0.05) were lower, while heart rate (p\<0.05) and TNF-alpha levels (p\<0.05) were higher compared with obese controls. After nCPAP therapy, patients showed a reduction in heart rate (p=0.036) and a higher cortisol suppression after dexamethasone (p=0.001) and there were no differences in insulin resistance (HOMA p=0.139), arterial blood pressure (p=0.183) and adipokines compared with baseline. Cortisol suppression was positively correlated with the improvement of apnea hypopnea index while on nCPAP therapy (r= 0.799, p=0.010).

Conclusions: Patients with OSAS present nocturnal hypercortisolism, hyperactivity of sympathetic central nervous system, a higher degree of inflammation and hypoadiponectinemia independent of the body mass index. Furthermore, hyperactivity of HPA axis and sympathetic nervous system are recovered by nCPAP.

Eligibility Criteria:
Inclusion Criteria:

* Aged from 18 to 65 years
* Body mass index between 35-60 who were submitted to polysomnography

Exclusion Criteria:

* History of smoking
* Sleep apnea treatment
* Cardiovascular disease
* Malignancies tumor
* Thyroid disorders
* Depression
* Subjects with known diabetes mellitus on medications
* Chronic renal or hepatic failure
* On hormonal replacement therapy, as well as use of medication that could potentially affect steroid hormone or cytokines secretion (alcohol, psychotropics, steroids, sympathomimetics, beta-blockers).
Validation of Continuous Transcutaneous Carbon Dioxide Monitoring in VA-ECMO Patients

Carbon dioxide in patients on veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is eliminated via respirator as well as via the oxygenator's membrane of the ECMO machine. Consequently, monitoring of end-tidal carbon dioxide tensions is limited, which can result in marked swings towards non-physiological values. Hyper- and hypocapnia, however, can have detrimental effects on organ perfusion in a great number of patients supported with VA-ECMO. Continuous, rapidly applicable monitoring of reliable carbon dioxide measures would therefore be extremely helpful to prevent harmful deviations from the norm. The investigators therefore try to assess the accuracy and the precision of continuously measured non-invasive transcutaneous carbon dioxide partial pressures when compared with tensions determined by blood gas analysis.

After documenting the characteristics of participants, cannulation site, and the cause for ECMO support, transcutaneous, arterial, venous, as well as end-tidal carbon dioxide partial pressure values are measured simultaneously at steady state conditions and compared with each other at various time points over a four-hour observation period. In addition, oxygen tensions are registered transcutaneously and in arterial and venous blood while respirator settings, sweep gas flow, ECMO flow, body temperature, volume status, and the dosage of vasopressors are also being recorded.

Eligibility Criteria:
Inclusion Criteria:

* Low cardiac output requiring VA-ECMO support.

Exclusion Criteria:

* Age \< 18 years
Uremic Toxin Removal With a New High Flux Cellulose Triacetate Membrane

Comparison of the uremic toxin removal by haemodialysis either with a low flux or a new high flux cellulose triacetate membrane

Comparison of the uremic toxin removal by haemodialysis either with a low flux or a new high flux cellulose triacetate membrane

Eligibility Criteria:
Inclusion Criteria:

* Chronic haemodialysis patient
* Serum albumin \> 3.6 g/dl

Exclusion Criteria:

* \< 18 years
Vaginal Elasticity Assessment Before and After Vaginal Carbon Dioxide Laser Treatment.

Female patients with either stress urinary incontinence (SUI) or vaginal wall weakness and prolapse will be evaluated for vaginal elasticity using vaginal tactile imaging both before and after Carbon Dioxide laser treatment.

Patients will be recruited and sign a consent form. The patients included are patients with SUI or vaginal wall weakness and prolapse. Each participant undergoes 3 laser treatments 4 weeks apart.

Assessment of vaginal elasticity via vaginal tactile imaging will be performed at 3 different points:

* Before the first treatment session (baseline).
* Before and after each treatment session.
* 3 months post final treatment. Every patient will serve as her own control. Demographic, gynecologic and obstetric history will be obtained from patients' electronic files.

Eligibility Criteria:
Inclusion Criteria:

* Any woman undergoing vaginal Carbon Dioxide laser treatment.

Exclusion Criteria:

* Women that are not in the age range.
A Study of the Effect of Tirzepatide on How the Body Handles Birth Control Pills in Healthy Female Participants

The purpose of this study is to look at how the body processes the commonly prescribed birth control pill, ethinylestradiol + norgestimate (EE/NGM), in healthy female participants and the effect of tirzepatide on how EE/NGM is processed by the body. Information about any side effects that may occur will also be collected.

Screening is required within 28 days prior to the start of the study. For each participant, the study will last about 20 weeks, including screening.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy females as determined by medical history, physical examination, and other screening procedures
* Have a body mass index (BMI) equal to or above 18.5 kilograms per meter squared (kg/m²), at screening
* Are not intending to start a family within 2 months after the study

Exclusion Criteria:

* Have known allergies to either tirzepatide or ethinylestradiol or norgestimate or related compounds
* Have a medical condition or medical history that precludes the taking of combined oral contraceptives
* Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase or gastrointestinal (GI) disorder (eg, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (eg, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors
* Have used hormonal implants or received hormonal injections in the past 12 months
* Unwilling to comply with smoking restrictions during the study
* Is a known user of drugs of abuse
The Effect of a Carbohydrate Drink on Cognitive Function and Exercise Performance

This study will investigate the effects of hydrothermally modified starch (SuperStarch) in adults. SuperStarch, originally developed as a drink for children with glycogen storage disease, is a slow digestible carbohydrate, maintaining blood sugar levels over extended periods. Therefore, it could be beneficial to exercise and mental performance, and could possibly have fat loss effects by increasing feelings of fullness. In this study, measures will be taken in 25 men to assess mental function, appetite, and metabolism to determine the processes involved in possible fat loss.


Eligibility Criteria:
Inclusion Criteria:

* healthy, 18 to 35 year old man or woman.

Exclusion Criteria:

* smoker
* pregnancy
* taking part in other research.
* followed a weight loss diet in the previous 6 months.
* history of gastrointestinal, endocrine, cardiovascular disease or diabetes.
* neurological or psychiatric condition that may cause cognitive dysfunction.
Bone Marrow Derived Mononuclear Cells for Ischemic Cardiomyopathy

This is an evaluative, monocentric study in patients with chronic ischemic heart disease and left bundle branch block who received an ICD-CRT. It is an early investigation on the safety and effects of a single administration of bone marrow derived mononuclear cells after implantation of an ICD-CRT device as an adjunct to CRT and usual drug treatment.


Eligibility Criteria:
Inclusion Criteria:

* chronic left ventricular dysfunction (ejection fraction \<35 %) in chronic ischemic heart disease and asynchronic contraction with indication for a biventricular stimulation (CRT, chronic resynchronization therapy), who do not have an improvement of \>15% of LVEF 3 months after CRT-device implantation
* wall motion dysfunction of any territory
* left bundle branch block
* Patients were on individual optimal treatment for chronic ischemic heart disease with one or a combination of the following drug types: diuretics, ß-blockers, ACE-inhibitors, AT1 blockers and/or lipid lowering agents for at least 30 days before CRT Implantation

Exclusion Criteria:

* patients with left ventricular dysfunction due to other reasons than ischemic cardiomyopathy, e.g. hypertension, dilatative cardiomyopathy
* with relevant valvular disease;
* Aneurysma of the anterior myocardial wall or myocardial wall thickness of \< 5 mm,
* with overt heart failure, other than ischemic cardiomyopathy,
* with history of stroke and/or transient ischemic attack (TIA),
* with history of thromboembolic event (e.g. phlebothrombosis, pulmonary embolism), bleeding disorders and known disease of the coagulation system;
* with extensive deviations of baseline laboratory values and significant findings at physical examination which in the opinion of the investigator may worsen under treatment;
* with severe systemic disease - (e.g. known or suspected anaphylaxia, intolerance against X-ray or contrast agent and, pre-malignant and malignant disease)
* atrial fibrillation with average heart rate \>70 bpm
* pregnant women and women of childbearing potential who have not had a negative pregnancy test within 48 hours before treatment;
* with any disease or condition that seriously compromises the function of other body systems than the heart and/or might interfere with conduct of the study and interpretation of the results;
* patients with a chronic or acute HIV-, HBV-, HCV-infection;
* improvement of more than 15% of LVEF 3 months after CRT-device implantation
* patients who have a ICD Implantation for secondary prophylactic indication. These patients show a history of resuscitation, VT or syncope.
* patients who are currently participating in another investigational drug or device study
Assessment of Functional and Symptom Outcomes for Survivors of Paranasal Sinus, Nasopharyngeal and Skull Base Tumors

To learn about the symptoms and changes our patients experience while receiving treatment for sinonasal or nasopharyngeal cancer

Objectives:

* To estimate the prevalence and severity of adverse and functional outcomes in survivors of benign and malignant paranasal sinus, nasopharynx and skull base tumors.
* To estimate the prevalence of health promotion behaviors during skull base tumor survivorship
* To identify possible mediators or predictors of survivorship outcomes and health behaviors in survivors of skull base tumors.
* To develop a database of demographic, clinicopathologic, recurrence, survival, functional and patient reported outcomes (PROS) for patients with benign and malignant paranasal sinus, nasopharyngeal and skull base tumors.
* To assess the utility and limitations of PROs in evaluating functional impairments and symptom burden in skull base patients.

Eligibility Criteria:
Inclusion criteria:

1. Previously untreated patients with or suspected to have sinonasal malignancy or nasopharyngeal malignancy diagnosis based on either outside pathology report or MD Anderson pathology report.
2. Age ≥ 18 years
3. Plan to obtain the majority of treatment at MDACC including surgery and radiotherapy
4. Ability to understand and willingness to sign written informed consent

Exclusion criteria:

1. History of the previous solid or liquid malignancies, apart from skin cancers treated with local therapy.
2. Existing neurocognitive impairment that is not the result of sinonasal and nasopharyngeal cancers or is treatment.
3. Previous treatment for sinonasal or nasopharyngeal carcinomas, apart from biopsy.
The Validity and Reliability of the Turkish Version of the CPAQ-8

Acceptance of chronic pain is becoming an increasingly important issue in the field of pain management. Many researchers argue that patients who accept pain better function better both physically and psychologically. In many countries, the Chronic Pain Acceptance Questionnaire - 8 (CPAQ-8) has been frequently validated and used to measure the pain acceptance of patients with chronic pain.1 However, the CPAQ-8 has not yet been introduced and validated in Turkey. In this study, we aimed to translate the English version of CPAQ-8 into Turkish, make correct cross-cultural adaptations, and validate the psychometric properties of the Turkish version of CPAQ-8 by testing it in Turkish fibromyalgia patients.

Chronic pain is an undesirable condition that affects a large part of the society and increases the psychological and economic burden of the population it affects. Psychological variables are known to be strong in the perception of pain and especially cause patients to avoid activity in order to reduce pain. Individuals prefer to avoid painful experiences when they are worn out in repetitive attempts to control and prevent pain, which ultimately causes pain to become more dominant and destructive, and activities that are valuable to the individual are neglected.1 At this point, accepting pain can be seen as the antithesis of avoiding painful experiences. Acceptance of pain is a strong predictor of low disability in chronic pain.2 The Chronic Pain Acceptance Questionnaire (CPAQ) represents one of the ways in which pain acceptance is functionalized and measured in the context of chronic pain. The short form of CPAQ, CPAQ-8, was developed and validated recently and shows the same factor structure, reliability and validity as the 20-factor version. Given that psychometric testing is an incremental process, further evaluation of the questionnaire is desirable, including test-retest reliability and replication of results reported by Fish et al.

Eligibility Criteria:
Inclusion Criteria:

* Patients who applied to our physical medicine and rehabilitation outpatient clinic,
* Agreed to participate in the study, were over the age of 18,
* Had at least primary school education, were diagnosed with fibromyalgia syndrome according to the 2016 American College of Rheumatology (ACR) criteria,
* Could speak and communicate in Turkish were included in the study.

Exclusion Criteria:

* Those who did not agree to participate in the study,
* \<18 years old, and could not communicate in Turkish
INSPIRE Pipeline™ Shield Post Approval Study

The purpose of the Pipeline™ Flex Embolization Device with Shield Technology™ Post Approval Study (PAS) ("Pipeline™ Shield PAS") is to collect on-label use data in patients undergoing treatment for intracranial aneurysms (IA) using the Pipeline™ Flex Embolization Device with Shield Technology™ ("Pipeline™ Shield Device") in a real-world post approval setting within the United States.

The INSPIRE Pipeline™ Shield Post Approval Study is an observational, prospective, multi-center, single-arm registry to collect on-label use data in patients undergoing treatment for intracranial aneurysms using the Pipeline™ Flex Embolization Device with Shield Technology™ according to the intended use.

The primary objective of this study is to evaluate the on-label use of the Pipeline™ Shield Device in patients undergoing treatment for intracranial aneurysms per institutional routine clinical care in a real-world post approval study setting in the U.S.

This study is conducted under the Product Surveillance Registry (NCT01524276) and is a sub-study to the therapy specific Neurovascular Product Surveillance Registry (NCT02988128).

Eligibility Criteria:
Inclusion Criteria:

1. Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements.
2. Patient is intended to receive or be treated with an eligible Medtronic product.
3. Patient is consented within the enrollment window of the therapy received, as applicable.
4. Patient or patient's legally authorized representative (LAR) has provided written informed consent using the IRB and Medtronic approved Informed Consent Form and agrees to comply with the study requirements. HIPAA/data protection authorization has been provided and signed by the patient (or patient's LAR).
5. Patient has already been selected for endovascular treatment of the target aneurysm with the Pipeline™ Shield Device as the appropriate treatment per the Pipeline™ Shield Device Instructions For Use (IFU).

Exclusion Criteria:

1. Patient who is, or is expected to be, inaccessible for follow-up.
2. Participation is excluded by local law.
3. Patient is currently enrolled or plans to enroll in a concurrent drug/device study that may confound the PSR results (i.e. no required intervention that could affect interpretation of all-around product safety and/or effectiveness).
4. Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study.
5. Patient is contraindicated for the device or procedure per the Pipeline™ Shield Device IFU.
6. The Investigator determined that the health of the patient may be compromised by the patient's enrollment.
7. Patient is enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval was obtained from Medtronic.