cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess NEU-627 in Healthy Participants

Phase 1, randomized, double-blind, placebo-controlled study of NEU-627 designed to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect.

This is a Phase 1 study that will utilize a randomized, double-blind placebo controlled single ascending dose schema, a 10-day multiple ascending dose schema, and open-label schemas to study food effect and to determine cerebrospinal fluid concentration of NEU-627. The study will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of NEU-627 in male and female healthy volunteers between 18 to 60 years old, inclusive.

Eligibility Criteria:
Inclusion criteria:

Participants are eligible to be included in the study only if all of the following criteria apply.

1. Male and female participants must be 18-60 years, inclusive, at the time of signing the informed consent;
2. Participants must be in good general health according to the judgment of the Investigator per local guidance;
3. Participants who have a body mass index (BMI) of 18-32 kg/m2 (inclusive);
4. When engaging in sex with a woman of child-bearing potential, both the male participant and his female partner must use highly effective contraception;
5. Legally and ethically capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply.

1. Clinically significant infection and/or dermatological, cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, neurological, or psychiatric disease which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the Investigator, unacceptably increase the participant's risk if he/she were to participate in the study;
2. Any history of malignant disease in the last 5 years;
3. Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions;
4. Use of or plans to use systemic immunosuppressive or immunomodulating medications during the study or within 3 months prior to the first study drug administration;
5. Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications;
6. Positive screen for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus antibody/antigen;
7. History of active, latent, or inadequately treated tuberculosis infection.

Additional details and criteria are outlined in the full study protocol.
The Safety and Efficacy of TET Enema in the Treatment of UC

Colonic Transendoscopic enteral Tubing(TET) is a novel, safe, convenient, and reliable procedure for Fecal Microbiota Transplantation(FMT).This clinical trail aims to evaluate the efficacy and safety of Mesalazine and Compound Glutamine enema in the treatment of Ulcerative Colitis through Colonic TET.

Enema is a conventional treatment for Ulcerative Colitis(UC). Mesalazine is suitable for the patients with mild to moderate UC.But for the UC with extending lesions, the conventional anema with Mesalazine or other medicine can not very effective.Colonic Transendoscopic enteral Tubing(TET) is a novel, safe, convenient, and reliable procedure for Fecal Microbiota Transplantation(FMT).Compared with the conventional enema, which is only used for local administration, the Colonic TET enema can achieve total colonic administration.This study aims to evaluate the efficacy and safety of Colonic TET for UC.Patients in this study will be divided into 5 groups according to certain criteria: the Mesalazine conventional enema group, the Mesalazine TET enema group, the Compound Glutamine conventional enema group, the Compound Glutamine TET enema group, the Mesalazine and Compound Glutamine TET enema group.Each group was given enema for 7 days.The primary outcome measure was the clinical remission efficacy rate in each group. The secondary outcome measure was the safety of TET.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients aged between 18 and 65
2. Patients with chronic relapsed mild to moderate active Ulcerative Colitis(left semicolon or extending colonic lesions)
3. Patients who can fully understand this study and voluntarily sign an informed consent;
4. Accept re-examination, follow-up examination and specimen retention in time
5. Suitable for colonoscopy and colonic TET;
6. A history of using Mesalazine and Compound Glutamine safely

Exclusion Criteria:

1. Anti-tumor necrosis factor or methotrexate was used within the first 8 weeks
2. Cyclosporine was used within 4 weeks
3. Antibiotics or probiotics was used within 4 weeks
4. Patients with risk of toxic megacolon, colon cancer or atypical hyperplasia found in pathology
5. History of colon surgery
6. Patients with moderate or severe renal impairment ,abnormal liver function,severe hypertension and cerebrovascular accident
7. Accompanied by other serious diseases, such as cancer or AIDS, that may hinder their enrollment or affect their survival
8. Patients with anxiety, depression, mental or legal disabilities
9. History of suspected or proven alcohol/drug abuse
10. Patients with explosive, massive bloody stools and severe illness who cannot tolerate the colonoscopy
11. Patients who are allergic to salicylic acid or aspirin
12. Patients with food allergies
13. Patients who are preparing to become pregnant during the study period
14. Patients considered by the researchers as unsuitable for enrollment
The Effect of Laughter Therapy on Students in the COVID-19 Pandemic

This study was designed as a randomized controlled, pre-test-post-test control group in order to determine the effect of laughter therapy on anxiety, life satisfaction and psychological well-being of nursing students. Laughter therapy was applied to the experimental group for at least 60 minutes, 10 sessions two days a week. For the evaluation, the state-continuity anxiety scale, life satisfaction scale, psychological well-being scale were applied at the pre-application stage (pre-test) and after the laughter therapy sessions (post-test). The following hypotheses were included in this study;

H1: Laughter therapy given during the Covid19 pandemic reduces the anxiety level of intern students.

H2: Laughter therapy given during the Covid19 pandemic affects the life satisfaction of intern students.

H3: During the Covid19 pandemic process, the laughter therapy given to interns affects the relationship between anxiety levels and life satisfaction.

H4: Laughter therapy given to intern students during the Covid19 pandemic process affects psychological well-being.

Today, all countries are struggling with COVID-19, which typically presents with mild symptoms but causes serious mortality in the world population. In addition to the routine changes due to the pandemic, face-to-face education has been switched to online education. The integration of online education and more technology into the curriculum than ever before has increased students' anxiety towards learning. It was also found to cause high levels of anxiety and stress, characterized by feelings of risk, insecurity, and unhappiness. Studies show that high levels of anxiety negatively affect students' adaptation to daily life and their life satisfaction levels. In recent years, non-pharmacological techniques have been widely used in reducing anxiety and stress. One of them is laughter therapy. Laughter therapy reduces feelings of negative stress, anxiety, and depression by increasing the body's readiness to deal with different types of problems. The aim of this study is to examine the effects of online laughter therapy on anxiety, life satisfaction and psychological well-being levels of nursing students, who have switched to online education during the pandemic process.

Eligibility Criteria:
Inclusion Criteria:

* A student of the Faculty of Health Sciences, Department of Nursing and enrolled in the fall semester,
* Who has not studied laughter yoga before or did not do laughter yoga,
* It will create students who agree to participate in the research.

Exclusion Criteria:

* Being a foreign national,
* Having a situation where laughter yoga is not recommended (having surgery in the abdominal region in the last three months, uncontrolled hypertension, chronic cough, incontinence, acute back pain, acute mental disorders, consumption of antipsychotic drugs, glaucoma, hernia, epilepsy),
* Students with simultaneous participation in any complementary treatment methods will be excluded.
SYREN Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Copegus (Ribavirin) in Non-Responder Patients With Chronic Hepatitis C (CHC) Genotype 1.

This study will evaluate the efficacy and safety of 4 regimens of PEGASYS plus Copegus, in patients with chronic hepatitis C (CHC) genotype 1 who have failed to respond to previous treatment with standard doses of PEGASYS plus ribavirin. Patients will be randomized to one of 4 groups, to receive a)PEGASYS 360 micrograms/week plus Copegus 1000-1200mg/day, b)PEGASYS 180 micrograms twice weekly plus Copegus 1000-1200mg/day, c)PEGASYS 360micrograms/week plus Copegus 1200-1600mg/day, or d)PEGASYS 180 micrograms twice weekly plus Copegus 1200-1600mg/day. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>=18 years of age, with CHC genotype 1;
* patients who have failed to respond to previous treatment with PEGASYS plus ribavirin for \>=12 weeks;
* patients who have discontinued PEGASYS/ribavirin \>=4 weeks prior to enrollment;
* compensated liver disease.

Exclusion Criteria:

* other forms of liver disease;
* infection with HIV, HAV, HBV;
* hepatocellular cancer.
Robot Assisted Supraomohyoid Neck Dissection Via Retroauricular Approach

In this study we introduce and evaluate the feasibility of our surgical technique to hide the external scar of neck dissection using the robotic system via a modified facelift or retroauricular approach.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as squamous cell carcinoma of the oral cavity
* no clinically identified cervical lymph node metastasis
* surgery as initial treatment

Exclusion Criteria:

* suspicious neck metastasis
* radiation or chemotherapy before the surgery
* past history of neck surgery
Virtual Reality Training for Trauma Resuscitation

This study individual training with an immersive virtual reality Trauma Simulator was compared to live mannequin-based simulation training in a facilitated group. The results showed that virtual reality simulator led to non-inferior effects on trauma resuscitation skills to mannequin-based simulation. Trauma Simulator had good usability, was well received by the participants, and had minimal adverse effects.

Background: Despite its high potential, the effect of immersive virtual reality simulation (VRS) in trauma resuscitation training has not been studied. The aim of this study was to test the hypothesis that VRS is non-inferior to mannequin-based simulation (MBS) in trauma resuscitation training.

Methods: In a single-center, randomized controlled non-inferiority trial, we compared individual training with an immersive virtual reality Trauma Simulator to live MBS training in a facilitated group. The primary outcome was the Trauma Score (ranging from 55 (worse) to 177 (best outcome)) during the MBS assessment. The secondary outcomes were the Trauma Score VRS assessment, System Usability Scale (ranging from 0 (worse) -100 (best outcome)), and Simulation Sickness Questionnaire (ranging from 0 (worse) to 235.62 (best outcome)).

Eligibility Criteria:
Inclusion Criteria: fluency in English. Exclusion Criteria: history of motion sickness
Treatment of Patients With Major Depressive Disorder With MK0869 (0869-059)

A clinical study to determine the efficacy and safety of MK0869 in the treatment of depression

The duration of treatment is 8 weeks.

Eligibility Criteria:
Major Depressive Disorder
Measurement of Joint Attention Fluency

The purpose of this research is to study joint attention. Joint attention plays a critical role in social and language development in children with and without autism. Joint attention is the shared attention between a child and another person. This study seeks to set a standard benchmark of frequency scores for joint attention. Finding a rate of engaging in joint attention behavior would offer a benchmark for all researchers and practitioners working with learners with and without autism.


Eligibility Criteria:
Inclusion Criteria:

* autism spectrum disorder

Exclusion Criteria:

* hearing or vision problems
* behaviors that are a danger to self or others
Fat Injection for Rectocele Treatment: A Novel Approach

This clinical trial aims to evaluate the effectiveness of autologous fat grafting as a novel treatment for rectocele, a condition characterized by the herniation of rectal tissue into the posterior vaginal wall. Women aged 18 to 60 years with mild to moderate rectocele, presenting with symptoms such as obstructive defecation or vaginal bulge, will undergo submucosal fat injections. The study will assess the procedure\&#39;s ability to alleviate symptoms and reduce prolapse recurrence. This prospective, single-arm trial will be conducted at Cairo University Hospitals.


Eligibility Criteria:
Inclusion Criteria:

* Female patients aged between 18 and 60 years.
* Diagnosis of rectocele confirmed by defecography, with a rectocele size of 2 cm (mild) to 4 cm (moderate).
* Presenting with symptoms of obstructive defecation syndrome, including constipation, incomplete defecation, and/or vaginal bulge.
* Able to provide written informed consent to participate in the study.

Exclusion Criteria:

* Patients who have previously undergone surgical repair of rectocele.
* Presence of thrombosed hemorrhoids.
* History of sclerotherapy injection for rectocele.
* Diagnosis of anal stenosis.
* History of coagulopathy or current use of anticoagulant or antiplatelet medications.
* Refusal or inability to provide informed consent.
Delivering Telemetry-Triggered Educational Content Using MyChart in Mood Disorders

Mood disorders - principally major depressive disorder and bipolar disorder - are a significant public health issue affecting one in four people during their lives in total, over 8 million Canadians are affected by mood disorders, costing the economy over $6 billion annually. At Sunnybrook, 75% of inpatient mental health admissions are due to mood disorders. Mood disorders are generally recurrent: approximately half of depression is recurrent; chronic bipolar disorder is typical. Use of ratings scales by patients and clinicians to track symptoms has also been shown to enhance outcomes such as remission, medication adherence, and patient engagement. Education is considered a key component of treating mood disorders. However, which educational information is useful can vary: in depression, changes in illness severity have been shown to affect what information is absorbed, and timing is also important.To address this, this project will deliver, for the first time ever, a system for using data from patients with mood disorders' electronic mood journals, integrated into Sunnybrook's "MyChart" personal health record system, to drive just-in-time delivery of educational interventions, using feedback from users to maximize its usefulness.

This project will integrate mood-journaling software ("MHT") developed here at Sunnybrook (SHSC) into SHSC's "MyChart" patient portal system. Next, using alternating expert input and input from focus groups of patients, we will develop a library of educational content and rules to select and drive delivery of content that will, for the first time, allow patients with mood disorders to receive customized, just-in-time educational content using their own self-report data to drive selection and timing of the delivery of the content. While we expect that this innovation should be beneficial to its users, we cannot assess this without adequate numbers of users. So, in this project, we will make this system available to MyChart users for six months and collect ongoing feedback on user satisfaction, continuously refining the system over the six months with the goal of steadily increasing the number of users frequently using this system.

Eligibility Criteria:
Inclusion Criteria:

i) Registered user of Sunnybrook Health Sciences Centre "MyChart" electronic patient portal

Exclusion Criteria:

-
Food and Nutrition Education in Quilombolas Communities With Food Insecurity: Multi-sector Intervention

To optimize the food security in quilombolas communities with high prevalence of food insecurity and obesity, the present study proposes to test a multi-sector intervention including agriculture sectors, health professionals and family members of communities, based on promotion of traditional food practices, health eating and enforceability of human right to adequate food.

The present study proposes to develop nutrition education strategies through multi-sector intervention in order to promote the consumption of healthy foods and improvements in the health status of the quilombola population.This is a non-randomized cluster trial in four quilombolas communities in Southern Brazil (Passo do Lorenço, Algodão, Serrinha do Cristal and Nova Palma), combining qualitative and quantitative methodologies.

Eligibility Criteria:
Inclusion Criteria:

Quilombolas certified communities in Rio Grande do Sul, Brazil, with higher prevalence of food insecurity and obesity.

Exclusion Criteria:

Community leaders with no interest in study intervention.
Safety Study of Fenofibrate During Pregnancy

The purpose of this study is to evaluate the safety of fenofibrate in severe hypertriglyceridemia pregnant women.

Due to changes in various hormone levels during pregnancy, triglyceride (TG) levels will increase physiologically. When TG\>10mM, the risk of pancreatitis increases, thereby threaten the maternal and fetal health. Therefore, when TG\>10mM, in addition to life interventions such as diet and exercise, drug treatment is required. Fenofibrate is the first-line TG-lowering drug, however, information on its safety during pregnancy is insufficient. According to the instruction, fenofibrate can only be used when the benefits outweigh the risks, that is, dietary control cannot effectively reduce TG (\>10g/L) and increase the risk of acute pancreatitis in the mother. This study involves two aspects. On the one hand, it evaluates the effect of fenofibrate on pregnancy outcomes through a retrospective study, and on the other hand, it evaluates its effect on children's growth and development, placental penetration, and milk excretion through a prospective study. 200 pregnant women with TG level\>10mM exposed to fenofibrate for more than one week will be recruited. The pregnancy outcomes will be compared to the unexposed women with TG level\>10mM. 50 TG level\>10mM pregnant women will be enrolled on receive fenofibrate treatment between weeks 24-39 of gestation and delivery for more than one week. According to the mother's wishes, maternal blood, cord blood, amniotic fluid at delivery and breast milk through 7 days after delivery will be collected and for fenofibric acid concentration determination. Moreover, in a one-year follow-up, the physical growth parameters of infants will be collected. The primary endpoint is the effect of fenofibrate on pregnancy outcomes and infant physical growth. The secondary endpoint is placental transfer and milk penetration of fenofibric acid.

Eligibility Criteria:
Inclusion Criteria:

* 20-45 years pregnant women; TG level ≥10mM； Voluntary signed informed consent (prospective study) or voluntary consent to use of medical information (retrospective analysis)

Exclusion Criteria:

* Evidence of decompensated liver disease; Pregnant women with major organ lesions; Has a history of kidney injury, creatinine clearance \<50ml/min, positive urine protein (\>300mg/L); Combined with other chronic diseases (epilepsy, severe intrahepatic cholestasis of pregnancy, severe preeclampsia, systemic lupus erythematosus, antiphospholipid antibody syndrome); B-ultrasound and other examinations during pregnancy have found fetal malformations, or suggested intrauterine growth retardation, or had birth defects or congenital malformations in the previous pregnancy; Pregnant women are participating in other studies or taking other fibrate lipid-lowering drugs
Does Frailty Help Predict Postoperative Outcomes in Cardiac Surgery?

This study will assess the benefit in using a frailty score to quantify accurate risk pre-operatively in patients undergoing major cardiac surgery in order to predict morbidity and disability-free survival post-operatively.

Increasingly, the group of patients undergoing cardiac surgery are older. Patients that are more elderly and frail are known to have an increase risk of injury to major organs following surgery including the heart, kidneys, and brain, all of which are associated with worse survival or diminished quality of life. It is becoming more important to be able to predict how well patients will fair in cardiac surgery, including predicting risk of complications (such as stroke or heart attacks) as well as long-term survival and quality of life. Currently, scores such as EUROscore can be used with good effect in predicting survival and major complications in cardiac surgery patients. However, frailty - the severity of a patient's weakness or fragility - has emerged as a potential candidate in predicting risk. Recent research has shown frailty score to predict risk of survival and complications following cardiac surgery and suggested to be possibly superior to pre-existing scores. The investigators wish to investigate the possible link between frailty and outcomes following cardiac surgery, in addition to current risk scores. The investigators also wish to determine whether frailty can effectively predict longer-term outcomes such as 'disability-free survival' - a patient-centred score that measures the ability of a patient to lead normal life activities. Patients undergoing major cardiac surgery at King's College Hospital will be recruited, following consent. The study will mainly involve questionnaires at various stages, starting at a pre-operative clinic. After surgery, follow up of patient's progress will be carried out at 3 days in hospital; and at 1 month, 3 months, and 6 months and 1 year via telephone. The investigators expect the results of this observational study to influence further research into the use of frailty risk scoring prior to clinical decisions, and add to the evidence in assessing risk-related outcomes in cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or over
* Due to undergo elective cardiac surgery: coronary artery bypass graft (CABG); valve replacement/repair; or transcatheter aortic valve implantation (TAVI) surgery
* Able to give informed consent
* Fluency in English

Exclusion Criteria:

* Emergency cardiac surgery and non-cardiac surgery
* Inadequate knowledge of English that will prevent patients from completing the consent or undertaking study assessments
* Severe visual, auditory, or motor handicap
* Concurrent diseases of the central nervous system,
* Patients at the extremes of frailty, in whom it would be unethical to perform a full assessment.