cyrilzakka/clinical-trials huggingface dataset:
Inhalational Anesthesia vs TIVA in Endoscopic Tympanoplasty

This study aims to prospectively compare surgical field quality and intraoperative blood loss between general inhalational anesthesia to total intravenous anesthesia (TIVA) alone in subjects undergoing endoscopic ear surgery. A secondary objective is to compare rates of emergence delirium and total recovery time between the two groups.

In sinus surgery, TIVA has been described as a possible advantage in the use of endoscopic ear surgery. However, to date, there are no studies that examine blood loss, surgical field quality, and recovery in TIVA compared to inhalational anesthesia in the setting of endoscopic ear surgery. The hypothesis is that in patients who undergo endoscopic tympanoplasty, those who receive TIVA will have reduced intraoperative blood loss, improved surgical field quality, and reduced emergence agitation than those who receive inhalational anesthesia. This study will be a prospective double-blinded randomized control trial consisting of subjects undergoing endoscopic tympanoplasty surgery to assess intraoperative blood loss, surgical field quality, rates of emergence delirium, and recovery time.

Eligibility Criteria:
Inclusion Criteria:

* Individuals of all ages
* Scheduled to undergo an endoscopic tympanoplasty

Exclusion Criteria:

* Individuals with anticoagulation disorders
* Those receiving anticoagulation therapy currently
Alcohol and Violence Prevention for College Students

Heavy episodic drinking and sexual assault (SA) are problematic on college campuses. This project will adapt already developed interventions targeting alcohol use and SA to a mHealth format and involve content that incorporates federal guidelines and CDC recommendations to integrate both bystander intervention and risk reduction content with new innovative personalized content for each risk group (cis-gender heterosexual men, cis-gender heterosexual women, and sexual/gender minorities). Alpha testing with key stakeholders, an open pilot trial, and a randomized pilot trial will be conducted to establish acceptability and to estimate sample size for a larger randomized controlled trial.

Specific aims are as follows:

Aim 1 (Stage IA): Modify Alcohol and Sexual Assault Prevention (ASAP) content to an eHealth format to include personalized content for each risk group (1. cisgender heterosexual men; 2. cisgender heterosexual women; and 3. sexual and gender minorities).

Aim 1a: Assess normative behaviors (n = 500) regarding alcohol use and SA for feedback.

Aim 1b: Adapt and assess initial acceptability of a workbook version of the intervention content among key stakeholders (college administrators and students from each risk group \[n=5 from each group\]).

Aim 2 (Stage IB): Open Pilot Trial. Obtain usability of ASAP among 30 students who engage in HED (10 from each risk group) in an open pilot trial.

Aim 3 (Stage IB): A pilot to assess effect size and variability for planning a randomized trial in the future. Randomize students who engage in HED to ASAP or control condition to observe preliminary effect sizes and estimate the variability using a 3-month follow-up. Sample size was determined to estimate the variability within a reasonable margin of error. This calculation also accounted the low base rates of SA and 20% attrition. This led to a sample size of 162 students (n=54 from each risk group).

Eligibility Criteria:
Inclusion Criteria:

* 18-25 years old
* Current student at university of study
* Valid email address at university of study
* Endorse engaging in heavy episodic drinking at least once in the past month on the screening survey

Exclusion Criteria:

* There are no exclusion criteria other than not meeting inclusion criteria
Atrovastatin for Preventing Atrial Fibrillation Following Open Cardiac Valve Repair

The purpose of the investigation is to determine whether Atrovastatin as anti-inflammatory agent can be effective in preventing from atrial fibrillation incidence in patients whom undergone open cardiac surgery for their heart valve repair.


Eligibility Criteria:
Inclusion Criteria:

* Greater than 25 y/o
* No occurrence of intra- or post-operative cardiopulmonary arrest
* Not consuming drugs affecting atrial rhythm
* Having sinus rhythm before surgery
* Lack of paroxysmal atrial fibrillation history
* Only undergo heart valve surgery
* Lack of considerable heart ischemia needed atorvastatin use
* Routine cares in ward, post-operative ward, and intensive care unit were done

Exclusion Criteria:

* Lesser than 25 y/o
* History of atrial fibrillation
* History of taking anti-arrhythmic drugs
* History of implementing pacemakers
* Severe heart failure
* Renal failure
* Hepatic failure
* Severe pulmonary diseases
* Heart block or bradyarrhythmia
* Routine cares in ward, post-operative ward, and intensive care unit were not done
* Performing concomitant cardiac surgery except valve repair
* Having considerable heart ischemia needed atorvastatin use
Accuracy of Gastric Ultrasound to Diagnose a "Full Stomach". A Bayesian Framework

During surgery, there is a risk that food or liquid in the stomach might be forced back up the throat where it could enter the lungs (aspirate) and result in serious complications or even death. This is why people going for surgery are required not to eat before their surgery. However, in emergency situations it is often not possible to know whether a patient has recently eaten or not. Anesthesiologists have recently developed an ultrasound test to determine if there is content in a patient's stomach and how much. This test involves an ultrasound examination of the abdomen and taking some measurements on the ultrasound screen.

The purpose of this study is to determine how accurate these measurements are. In other words, how good are we at detecting an empty stomach from one that has liquids, or solids in it. You are being asked to participate in this study because we require non-pregnant volunteers in order to answer the aforementioned study question.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers aged 18 to 85 years
* Male or female
* American Society of Anesthesia physical status classification I and II
* Height greater than 145 cm
* Ability to understand the study protocol and provide informed consent

Exclusion Criteria:

* Subjects predisposed to have an increased residual gastric volume at baseline (eg. Diabetes or any known dysmotility)
* History of major upper gastrointestinal disease (including hiatus hernia or prior gastroduodenal surgery)
Patient Reported Outcomes (PROs) in Anal Cancer Patient Treated by Intensity Modulated Radiotherapy (IMRT).

Radiochemotherapy is the standard treatment for neoplasms of the anal canal with excellent rates of local control and preservation of the anal sphincter. However, patients may experience a deterioration of quality of life related to sequelae of the treatment particularly at intestinal, anal sphincter and sexual level. Few studies to date have documented patient-reported outcomes (PROs) in this area. The aim of this observational study is to verify the quality of life (QOL) of the patients by means of self-completed questionnaires.

In recent times, the focus on collecting patient-reported outcomes (PROs) has increased in healthcare. The Food and Drug Administration defines PROs as a -measurement of any aspect of a health status of the patient that comes directly from the patient-. These includes disease symptoms, functional aspects and quality of life (QOL). The collection of PROs, combined with physician-assessed toxicity, is constantly being incorporated into clinical practice and studies to provide a more holistic picture of the impact of treatment on patients and prove useful for planning future interventions. Although the use of PROs has now become the standard for measuring quality of life of patients there are still few studies on the self-reported long-term QOL of anal cancer patients and on disease or therapy related symptoms that affect QOL. Therefore, the EORTC (European Organisation for Research and Treatment of Cancer) has recently developed the specific Quality of Life Questionnaire for anal cancer (QLQ-AN27) module to explore typical symptoms of anal cancer and its therapy. In this study, the QLQ-AN27 questionnaire will be administered together with the EORTC Quality of Life 30 (QLQ 30) in patients with anal cancer who have undergone radio-chemotherapy. The questionnaire may be administered before treatment, after treatment and during follow-ups until completion of the fifth year. This is an observational study both retrospective and prospective.

Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) 0-3
* minimum 18 years old
* squamous cell carcinoma of the anal canal
* low burden of metastatic disease at diagnosis
* indication for radiochemotherapy treatment
* informed consent

Exclusion Criteria:

* age under 18 years
* Eastern Cooperative Oncology Group (ECOG) higher than 3
* metastatic disease at diagnosis not amenable to radiochemotherapy treatment
Postural Control, Grip Strength and Body Posture in Children With Intellectual Disability and Dyslexia

This study investigates physical changes in children with Dyslexia and Intellectual Disability. Participants divided into three groups and Body Posture, Postural Control and Hand Grip Strengths was evaluated.

Children with Intellectual Disability and Dyslexia have academic and behavioral problems but also they might have physical changes related to poor motor development.

Three evaluation method was used in study. Postural Deformities were evaluated by PostureScreen Mobile App which is a mobile app allows to assess photographic body posture in four aspects (anterior, posterior, lateral) Postural Control was tested by Wii Balance Board. Wii balance board is a force plate that can measure person's center of gravity displacements Hand grip strength tested by Jamar Hand Dynamometer. It was completed according to American Hand Therapist's Association guidelines.

All data collected from participants have analysed within the control group (typical developed children)

Eligibility Criteria:
Inclusion Criteria:

1. no comorbid diagnosis alongside ID and Dyslexia (dysgraphia, dyscalculia, attention deficit hyperactivity disorder, etc.)
2. no orthopedic/physical disability

Exclusion Criteria

1. Presence of previous training for physical or motor development
2. Previous surgery.
Study of the Efficacy of Losartan on Aortic Dilatation in Patients With Marfan Syndrome

The purpose of this study is to evaluate if losartan limits aortic dilatation in patients with Marfan syndrome.

Aim : evaluate the efficacy of losartan for limiting aortic dilatation in patients with marfan syndrome receiving standard therapy

Inclusion criteria :

10 years or older Marfan syndrome according to international criteria Signed informed consent

Non inclusion :

Previous surgery of the ascending aorta, or surgery planned Non echogenicity Contre-indication lactose Pregnancy on going or planned within 3 years Breast feeding Participation in another clinical study Non member of the social security or CMU

Number of subjects : the number of subjects (150 per group) is derived from the study from Shores et al (1994) demonstrating the benefit of beta-blockade in Marfan patient and uses a decrease by half of the aortic dilatation with losartan

Follow-up is 3 years, after inclusion period of 2 years. A total of 5 years is expected

Methods : randomised double blind vs placebo study. All French centres de competence for marfan syndrome and the centre de reference are participating in the study.

End points : main endpoint is evolution of normalised aortic diameter. Secondary endpoints include clinical events (cardiac surgery or aortic dissection, hospitalisation in cardiology department, death), tolerance of the drug, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* 10 years or older
* Marfan syndrome according to international criteria Signed informed consent

Exclusion Criteria:

* Previous surgery of the ascending aorta, or surgery planned
* Non echogenicity
* Contre-indication lactose
* Pregnancy on going or planned within 3 years
* Breast feeding
* Participation in another clinical study
* Non member of the social security or CMU
Improving Screening and Therapy for Hispanic/Latinx at Risk for CKD

In this study, the investigators will utilize community organizations to screen Hispanics/Latino(a)s for kidney disease, diabetes, and other risk factors, and refer them for care with a PCP. Additionally, the investigators will implement an intervention in local health clinics to assist PCPs with screening and treating patients with diabetes.

Completion of the project will hopefully slow progression of kidney disease among Hispanic/Latino(a) patients in Durham, and the information gained will allow the investigators to eventually perform the intervention on a larger scale.

The goals of this study are to (1) Increase rates of screening and monitoring of CKD and CKD risk factors for Hispanic/Latinx community members in Durham by utilizing existing community resources and screening events and (2) Pilot test a PCP-facing intervention to promote guideline concordant testing and evidence-based therapy provision for Hispanics/Latinx with T2D at community health centers, utilizing clinical champions and pharmacists. The investigators anticipate the study will identify patients with CKD or CKD risk factors and establish feasibility of the pilot intervention, which the investigators plan to ultimately apply on a large scale to reduce inequities and improve clinical outcomes among Hispanics/Latinx.

Eligibility Criteria:
Aim 1:

Inclusion Criteria:

* Age 18 or older at time of screening
* Self-identifying as Hispanic/Latinx ethnicity.

Exclusion Criteria:

* Unable to be reached by telephone
Translational Analysis In Longitudinal Series of Ovarian Cancer ORganoids

This is a longitudinal observational phase II, single center, single arm study on the reliability of high grade serous ovarian carcinoma organoids obtained from primary debulking surgery (PDS)+adjuvant chemotherapy and neoadjuvant chemotherapy + interval debulking surgery (NACT+IDS) cases as model for the patients' response to treatments. Since organoids represent a model system comparable to patient-derived xenografts, the investigators tested the null hypothesis that the possibility of correctly identifying the drug-sensitivity could improve from 80%, as assessed by xenografts to at least 95%. The first step was planned to include 7 patients; if 5 or more patients do not respond, the trial will be terminated. If the trial goes on to the second stage, a total of 43 patients will be studied. Considering a patient dropout of approximately 10%, the study was planned to enroll at least 48 patients.

In this project, the investigators propose to employ the patients-derived organoid technology to test HGSOC organoids obtained from PDS+adjuvant chemotherapy and NACT+IDS cases to predict patients' response to treatments; moreover, the investigators aim to study genomic and phenotypic evolution of HGSOC organoids from PDS+adjuvant chemotherapy and NACT+IDS patients undergoing relapse. Finally, the investigators intend to investigate splicing-targeting technologies as new potential therapeutic treatments to increase vulnerability of HGSOCs. FIGO stage IIIC or IV ovarian, fallopian tube, or primary peritoneal cancer patients will be included if disease at metastatic sites is supposed to be completely resectable and they will be triaged for staging laparoscopy to obtain histologic diagnosis and to provide the tumor load assessment through the laparoscopic score. If PDS is chosen, open cytoreduction will be performed at the same time and bioptic tissue will be collected for organoids; otherwise, women will be submitted to NACT followed by IDS and tissue for organoids will be collected from both staging LPS biopsy (pre-) and subsequent surgery (post-NACT). Part of each surgical specimen will be used to obtain organoids, whereas part will be frozen for direct comparative analysis of the original tumor. 1-6 organoids from each patient will be prepared from PDS or NACT-IDS patients (pre- and post-NACT) and blood samples will also be collected to purify extracellular circulating RNA (cRNAs).

Eligibility Criteria:
Inclusion Criteria:

1. age between 18 and 75 years
2. estimated life expectancy of at least 4 weeks
3. performance status (PS) according to Eastern Cooperative Oncology Group (ECOG) \< 2
4. adequate bone marrow, respiratory, hepatic, cardiologic medullary and renal function (creatinine clearance \< 60 ml/min according to Cockroft formula)
5. histologic diagnose of epithelial ovarian cancer at frozen section and laparoscopic score ≥ 8 or ≤ 12 (considered HTL) with no evidence of mesenteric retraction

Exclusion Criteria:

1. Pregnancy or breast-feeding
2. History of concomitant or previous malignancy in the last 5 years
Meleis's Transition Theory on Postpartum Difficulties and Quality of Life in Primipara Mothers

The randomized controlled experimental study sought to determine the impact of the training structured according to Meleis's Transition Theory on postpartum difficulties and quality of life in primipara mothers.

In the study, the intervention group (39 mothers) was given face-to-face training in the hospital, which was structured according to Meleis' Transition theory, 24 hours after the cesarean section.Telephone counseling was provided on the 5th, 15th and 42nd days after discharge. Thus, these mothers were followed up 4 times in the postpartum period. No intervention was made in the control group (40 mothers).

Eligibility Criteria:
Inclusion Criteria: Mothers with the following criteria were included in the study;

* Primiparous
* Cesarean delivery
* Over 18 years old
* At least primary school graduate
* Communicating verbally
* Using mobile phone and whatsapp application
* Married and living with spouse

Exclusion Criteria: Mothers with the following criteria were excluded from the study;

* Having a risky pregnancy history
* Having a history of chronic disease
* Diagnosed with a psychiatric illness
* Having a health problem in herself or her baby that requires separation from each other
* Having a baby with any congenital anomaly or severe disease detected at birth
Effects of a Single Oral Dose of KETone Ester ON Exercise Performance in Patients With Chronic Heart Failure

In a randomized, double-blind, placebo-controlled cross-over design, subjects will either receive a supplemental drink containing a commercially available ketone ester (DeltaG®, 500 mg/kg body weight), or a taste matched, isovolumic placebodrink and will then perform the 31phosphorus Magnetic Resonance Spectroscopy (31P MRS) exercise protocol. After 1-2 weeks, subjects will cross-over and repeat the 31P MRS exercise protocol, this time receiving the other treatment.

The goal of this study is to investigate if oral ketone supplementation stimulates mitochondrial ATP production and improves exercise performance in patients with chronic HF. In a randomized, double-blind, placebo-controlled cross-over design, subjects will either receive a supplemental drink containing a commercially available ketone ester (DeltaG®, 500 mg/kg body weight), or a taste matched, isovolumic placebodrink and will then perform the 31P MRS exercise protocol. After 1-2 weeks, subjects will cross-over and repeat the 31P MRS exercise protocol, this time receiving the other treatment. Endpoints include rate and magnitude of change in phosphocreatine (PCr) and inorganic phosphate (Pi) concentrations from baseline to maximum exercise, rate and magnitude of change in PCr and Pi concentrations during recovery, rates and magnitude of change in intramuscular pH during exercise and recovery, maximal exercise performance and change in concentrations of beta-hydroxybutyrate and other metabolites before consumption of the supplemental drink, after consumption of the supplemental drink and after exercise.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Heart Failure NYHA II - III
* LVEF ≤40%
* Stable for the last 1 month prior to the study

Exclusion Criteria:

* Age \<18 years;
* Unable or unwilling to undergo exercise MRI (physical disabilities, claustrophobia);
* Unable to complete the exercise protocol during the screening visit according to the professional opinion of the investigators;
* Comorbidities which can influence study results such as muscular dystrophies, peripheral artery disease, diabetes mellitus, severe anaemia (defined as Hb ≤6 mmol/L);
* Pregnant/trying to get pregnant/breastfeeding during the period from the first exercise test until 4 weeks after the last exercise test);
* Absolute contra-indications to undergo MRI according to the current UMCG protocols and guidelines (e.g. non-conditional medical device, recent device implantation, incompatible ferromagnetic objects in the body).
* BMI \< 16 kg/m2; BMI \> 35 kg/m2
* Unable to understand study procedures;
* Unable or unwilling to provide informed consent.
A Trial of Tadalafil and Glycemic Traits

The purpose of this study is to find out if tadalafil can help overweight and obese people metabolize blood sugar more efficiently. The investigators also want to find out if 20 mg/day of tadalafil for 3 months is safe to take without causing too many side effects. The investigators are plan to enroll 100 subjects at Massachusetts General Hospital (MGH).

This study is examining changes in insulin resistance and glucose tolerance following 3 months of treatment with oral, once daily tadalafil.

The investigators primary hypotheses are that measurable decreases in insulin resistance (as measured by HOMA-IR) and increases in insulin sensitivity (as measured by the Matsuda index) will occur following 3 months of treatment with oral tadalafil 20 mg daily compared to placebo.

The investigators secondary hypotheses are that improvements in average glycemia (as measured by hemoglobin A1C), pancreatic beta cell function (as measured by the oral disposition index), and body composition (including weight, waist circumference, body mass index, and waist-hip ratio) will occur as a result of tadalafil-mediated changes in the cGMP pathway.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years and \< 50 years
* BMI \> 30 kg/m2
* Fasting insulin \> 10 uU/mL

Exclusion Criteria:

* Systolic blood pressure (SBP) \< 100, \> 150 mmHg
* Current anti-hypertensive medication use, including diuretics
* Current use of organic nitrates
* Current use of PDE-5 inhibitors (sildenafil, tadalafil, vardenafil)
* History of reaction to PDE-5 inhibitors
* Known HIV infection
* Use of medications that strongly alter CYP3A4 activity
* History of myocardial infarction, angina, uncontrolled cardiac arrhythmia, stroke, transient ischemic attack, or seizure
* Known non-arteritic ischemic optic retinopathy (NAIOR)
* History of hearing loss
* Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73 m2 by the modified diet in renal disease (MDRD) equation
* Hepatic transaminase (AST and ALT) levels greater than three times the upper limit of normal
* Known pregnancy or those unwilling to avoid pregnancy during the course of the study
* History of priapism
* Use in excess of four alcoholic drinks daily
* History of diabetes mellitus or use of anti-diabetic medications
* Known anemia (men, Hct \< 38% and women, Hct \< 36%)