cyrilzakka/clinical-trials huggingface dataset:
Study Evaluating SRA-333 in Mild to Moderate Alzheimer's Disease (AD)

To determine the safety and tolerability of multiple ascending fixed oral doses of SRA-333 in subjects with mild to moderate Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable AD according to the NINCDS-ADRDA criteria.
* Men and postmenopausal or surgically sterile women aged from 50 to 85 inclusive.
* Able to give informed consent. Patient's caregiver must consent to participate in the study.

Exclusion Criteria:

* Significant neurologic disease other than AD that may affect cognition.
* Current clinically significant systemic illness which is likely to deteriorate or affect the subject's safety during the study.

Other exclusions apply
Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse

The study aims to investigate whether behavioral interventions promote cessation in adult smokers by ameliorating negative emotions and improving self-control and identify the neural markers of these effects.

The primary objectives of this study are to compare the effectiveness of two types of behavioral interventions, when combined with varenicline medication, in promoting tobacco cessation among treatment-seeking adults and to elucidate the underlying mechanisms. The secondary objective of this study is to examine sex differences.

Investigators will recruit from two primary sources: 1) community-based recruitment strategies including web and social media ads, lay community members to recruit, and local communication channels; 2) investigators will invite referred patients to the outpatient Tobacco Treatment Service (TTS) at Yale-New Haven Hospital.

All participants will be assigned to one of two behavioral interventions. Both groups will receive treatment with varenicline and attend weekly individual counseling sessions (standard care or cognitive behavioral therapy for insomnia) and wear research-grade sleep actiwatches for passive sleep monitoring.

Participants will have a total of five expected research visits with a scheduled target quit date for Week 4. Participants will undergo MRI at baseline and at Week 4, and attend follow-ups at week 8, 12, and 26.

Eligibility Criteria:
Inclusion Criteria:

* English literate
* report heavy tobacco use (including nicotine e-cigarettes) for \>1 year
* meet biochemical cut off for recent cigarette smoking or e-cigarette use
* optimal body mass index

Exclusion Criteria:

* currently enrolled in other treatments
* neuropsychiatric exclusions that could interfere with study participation, increase risk of adverse events, and/or induce deficient sleep
* medical contraindications for fMRI, varenicline, and/or behavioral treatment
* factors that cause deficient sleep and for which behavioral treatment has less benefit
* women who are pregnant or nursing
Beating Versus Arrested Heart for Mitral Valve Replacement

The purpose of this study is to evaluate the immediately clinic and ultramicroscopic myocardial cellular ischemia and reperfusion to replace of the mitral valve using arrested heart versus on-pump empty beating heart surgical techniques.

During open-heart surgery prevention of ischemia and reperfusion following cardioplegic arrest are essential for myocardial protection. Beating heart surgery on normothermic bypass simulates physiologic cardiac status and is good method for myocardial protection. A comparison of both available techniques for valve replacement arrested heart versus on-pump empty beating heart of the clinical and ultramicroscopic myocardial alterations will allowed to better understand myocardial protection because eliminated the use of cardioplegia and the corollary risk of ischemic reperfusion injury.

Eligibility Criteria:
Inclusion Criteria:

* all patient included into the study were adults 18-60 years old,
* with an echocardiography diagnosis of mitral and/or tricuspid valve disease due to inflammatory acquired diseases,
* no previous history of cardiac surgery and d) elective indication for valve replacement.

Exclusion Criteria:

* with metabolic diseases such as diabetes mellitus and uremia,
* with coronary artery diseases,
* dilated myocardiopathy,
* with severe chronic pulmonary obstructive diseases,
* with present or past history of malignant diseases,
* acute endocarditis
* with severe pre-operatory laboratory parameters such as creatinine levels \> 3mg/dL, Hemoglobin ≤ 7.0 g/dL, Prothrombin time/activity ≤ 70% and clotting time ≥ 10 minutes.
Study on the Mechanism of Eating Disorder

Eating disorders (EDs) are severe chronic psychiatric disorders with a not fully understood etiopathogenesis. Previous studies have revealed some biological mechanisms of EDs. However, the etiology and maintenance mechanism of EDs, especially the neuro-mechanisms is still unknown. To explore the pathogenic mechanism and treatment biomarkers of EDs, we design this study. the multidimensional data including the clinicopathological features, neuroimaging data (functional and structural magnetic resonance imaging), electroencephalogram and inflammatory cytokines will be used to investigate the biomarkers for diagnosis and treatment effectiveness.


Eligibility Criteria:
Inclusion Criteria:

Anorexia nervosa

1. Anorexia nervosa according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5);
2. Age: 13-35 (including 13 and 35)
3. BMI: 13-17.5kg/m\^2
4. The participants and/or their legal guardians ( for participants who are younger than 18-year-old) sign the informed consent form voluntarily and agree to participate in all visits and examinations as required by the trial protocol.
5. Do not take any psychiatric medications in past one month.

Bulimia nervosa

1. Bulimia nervosa according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5);
2. Age: 13-35 years old (including 13 and 35)
3. The participants and/or their legal guardians ( for participants who are younger than 18-year-old) sign the informed consent form voluntarily and agree to participate in all visits and examinations as required by the trial protocol.
4. Do not take any psychiatric medications in past one month.

Exclusion Criteria:

1. Patients who meet DSM-5 diagnostic criteria for other mental disorders: Major depressive disorder, anxiety, obsessive-compulsive disorder, personality disorder, mental retardation; drug and/or alcohol dependence;
2. Patients who receive repetitive Transcranial Magnetic Stimulation (rTMS) or modified electroconvulsive therapy (MECT) treatment in past six months.
3. Patients with severe suicidal tendencies or suicidal behavior
4. Pregnant or lactating women;
5. Patients with MRI contraindications;
6. Patients who are regarded as unsuitable by investigators for this clinical trial.
Volume Challenge Added to DSE in the Diagnosis of Severe LFLGAS

The aim of this study is to test the diagnostic added value of Volume Challenge (VC) to low-dose dobutamine stress echocardiography (LDDSE) in patients with a low-flow, low-gradient aortic stenosis (LFLGAS). This study will assess if LDDSE plus VC allows to increase the proportion of patients in whom a true severe AS can be differentiated from a pseudo severe AS.

The design of the study is a monocentric prospective non-randomized pilot clinical trial. A standard LDDSE will be performed. The stroke volume (SV) will be recorded. The addition of VC with the passive leg raise method at peak dobutamine dose will be performed. A transesophageal echocardiography (TEE) with low dose dobutamine and a bolus of normal saline will be performed as a validation method to measure AVA with the planimetry method. The SV will be recorded. Proportion of patient receiving the diagnosis of true severe AS defined as a combination of AVA \<1.0 cm2 and ∆SV ≥ 20% will be compared between standard LDDSE and LDDSE with addition of VC. Calculating sensitivity, specificity, performing ROC curve analysis and calculating the Youden-index, the accuracy of the test method (LDDSE plus passive leg raising) for the detection of truly severe AS in comparison with the reference method (TEE) will be determined.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Written informed consent
* Patients with LFLGAS (mean Gradient: \< 40 mmHg, AVA ≤ 1.0 cm2 (by continuity equation using LVOT diameter) SVI ≤ 35 ml/m2), by rest TTE

Exclusion Criteria:

* Hypersensitivity to dobutamine or midazolam
* Lack of safe contraception defined as: Female participants of childbearing potential not using and not willing to continue contraception for study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices.
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.,
* Enrolment of the investigator, his/her family members, employees and other dependent persons
* Previous enrolment into the current study,

ADDITIONAL SPECIFIC EXCLUSION CRITERIA REGARDING STRESS ECHOCARDIOGRAPHY:

* Systolic left ventricular ejection fraction (LVEF) \< 20%
* More than mild aortic regurgitation
* Mitral valve disease, defined by mitral valve area \< 2.0 cm2 or more than mild mitral regurgitation
* Unstable angina
* Acute pulmonary oedema
* Signs of relevant left ventricular heart failure defined as crackles more than one fourth of lung field on auscultation
* Signs of relevant right ventricular heart failure defined as central venous pressure (CVP) \> 15 mmHg estimated with dilatation and collapsibility of vena cava inferior (VCI)
* Severe pulmonary, renal or hepatic disease

ADDITIONAL SPECIFIC EXCLUSION CRITERIA REGARDING TRANSESOPHAGEAL ECHOCARDIOGRAPHY:

* Oesophageal varices
* History of bariatric surgery
Fascial Closure Techniques Post-Operative Pain Laparoscopy

This study compares post-operative incisional pain on post-operative days 1 and 7 who will undergo gynecologic laparoscopic operations. Half of participants will undergo conventional fascial closure, while the other will undergo fascial closure by Berci Fascial Closure (Karl Storz, Belgium).

Studies have demonstrated that laparoscopic surgery has numerous advantages over laparotomy. The patients who undergo laparoscopic surgery acquired fewer doses of analgesics than who undergo laparotomy. This point is also one of the advantages of the laparoscopic surgery. The fascia closure in fascial defects larger than 10 mm diameters in laparoscopic surgery is an important issue. Incisional hernias may occur after laparoscopic surgery. The surgeons prefer the techniques in fascial closure which is more safe and cause less pain. In current study, investigators aim to compare the post-operative incisional pain in two different techniques in gynecologic laparoscopic surgery; conventional versus by 'Berci Fascial Closure'.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-65 years
2. Ability to understand the inform consent
3. No conversion from laparoscopy to laparotomy

Exclusion Criteria:

1. No-ability to understand the inform consent
2. Conversion to laparotomy from laparoscopy
Sitosterolemia Metabolism

Ezetimibe has become the treatment choice for patients with sitosterolemia. Ezetimibe is an inhibitor of cholesterol absorption from the gastrointestinal tract. The purpose of this study is to determine if ezetimibe improves whole body plant sterol and cholesterol homeostasis.


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of homozygous sitosterolemia as established by genotyping and clinical parameters

Exclusion Criteria:

* pregnant
* intellectual disability
* major infectious diseases
* immunodeficiency
* cancer
* renal failure
* diabetes
Autologous Platelet-Rich Plasma in the Management of Asherman Syndrome

The aim of the study is to find out the benefit of the platelet-rich plasma in preventing reformation of intrauterine adhesions after adhesiolysis in cases of Asherman syndrome

Patients fulfilling criteria will be randomized into three equal groups. The patients who are diagnosed previously with severe AS will choose an envelope which determines the treatment method. There will be 60 envelops assigning for the groups mixed together in one box. This will ensure a randomized allocation of patients to either group of this study.

Hysteroscopy adhesiolysis will be done to all participants in the study. in the first group, Adhesiolysis will be followed by intrauterine use of PRP then insertion of intrauterine Foley balloon catheter that will be inflated and left for 2 weeks. in the second group, adhesiolysis will be followed by insertion of intrauterine Foley balloon catheter covered by freeze-dried amniotic graft and will be inflated and left for 2 weeks. In the third group, Adhesiolysis will be followed by insertion of intrauterine Foley balloon catheter that will be inflated and left for 2 weeks. All patients will be given antibiotics and hormonal treatment. Also, they will be given low dose aspirin and sildenafil 50mg daily.

Eligibility Criteria:
Inclusion Criteria: Severe intrauterine synechia confirmed by hysteroscopy

* age group from 20 to 40 years

Exclusion Criteria:

* Hemoglobin less than 11 g/dl
* Platelet less than 150000/mm3
* Patients taking anticoagulants
* Patients taking NSAID in the 15 days prior to the procedure
* Active cervical or uterine infection
The Effect of Artificial Sweeteners on Blood Glucose Response

The purpose of this study is to determine whether the presece of the artificial sweeteners aspartame, saccharin and asceulfame-k affect the blood glucose responses to an orally incested glucose solution.

Sweet taste receptors, similar to those located on the lingual taste buds have been located along in the lining of the gut. Recent studies have demonstrated that activation of these sweetness taste receptors, either by sugars such as glucose, fructose, lactose, or artificial sweeteners such as saccharin and aspartame can influence the way nutrients, including glucose are absorbed from the gut into the bloodstream. Studies in animal models have shown that activation of the sweet taste receptors can increase the expression of the sodium-dependant glucose transporter 1 (SGLT1) and glucose transporter 2 (GLUT2) which transport glucose from the lumen into the bloodstream. Thus providing a potential mechanism by which glucose uptake can be regulated. Although artificial sweeteners stimulate the sweet taste receptors, they have little nutritive value, so that when they are consumed in the absence of any other nutrients there is little effect on blood glucose response. However, the effects of consuming artificial sweeteners in combination with sugars such as glucose is unclear. The purpose of this study is to investigate whether the addition of artificial sweeteners to an orally consumed glucose solution affects the rate at which the glucose appears in the blood.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Aged 18-45 years
* BMI (19-25 kg/m2)
* Weight stable in past 3 months

Exclusion Criteria:

* Smoking
* Females who are pregnant of breastfeeding
* Regular intake of emdication, other than females taking oral contraceptives
* Medical illness
* Gastrointestinal disorders
* Food allergies
Gemcitabine Plus Bevacizumab in Locally Recurrent or Metastatic Breast Cancer

To determine how long Gemcitabine and Bevacizumab will stop the cancer from growing in patients with advanced breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Must be female and greater than or equal to 18 yrs of age
* Participants must have confirmed cancer with measurable or evaluable, locally recurrent or metastatic disease.
* Participants must have received a taxane as neo-adjuvant and/or adjuvant therapy
* Participants may have received prior hormone therapy for locally recurrent or metastatic disease

Exclusion Criteria:

* Participants with breast cancer overexpressing Human Epidermal growth factor Receptor 2 (HER2) gene amplification
* Prior chemotherapy or targeted therapy for metastatic breast cancer
* Prior treatment with gemcitabine, trastuzumab, lapatinib or bevacizumab in any setting
* History of, or active brain mets
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to treatment, or anticipation of need for major surgical procedure during course of study
* Prior history of high blood pressure crisis
* Have a serious, nonhealing wound, ulcer, or bone fracture
Mitral Splay Sign, Its Mechanism and Association With Severity of Regurgitation

To study echocardiography splay sign in mitral regurgitation and its association with mitral regurgitation severity and doppler band artifact ('seagull cry').


Eligibility Criteria:
Inclusion Criteria:

* any patient undergoing echocardiography for clinical indications

Exclusion Criteria:

* poor quality of recorded echocardiography study
* inability to ascertain severity of mitral regurgitation
A Quantitative Study to Assess the Construct Validity of the Prescription Opioid Misuse and Abuse Questionnaire

The purposes of this study are to evaluate the validity and reproducibility of the POMAQ to identify opioid abuse and misuse behaviors among participants who have chronic pain which requires long-term opioid use.

The Food and Drug Administration (FDA) has requested, as part of a Post-marketing requirement (PMR) for new drug application (NDA) holders of extended release/long-acting (ER/LA) opioids, to conduct a study to develop and validate a measure of the opioid-related adverse events misuse and abuse among patients with chronic pain prescribed long-term opioid therapy. This measure will be used to assess misuse and abuse in PMR Study 2065-1A and PMR Study 2065-4B.

To date, no tool currently exists to address the needs of the PMR except for the Self-Report Misuse, Abuse and Diversion of Prescription (Rx) Opioids questionnaire (SR-MAD) which has undergone several rounds of content validation but requires further validation. The SR-MAD has been substantially modified to meet the needs of PMR Studies 2065-1A and 2065-4B and has been renamed the Prescription Opioid Misuse and Abuse Questionnaire (POMAQ). The POMAQ will undergo content validation via qualitative interviews (Protocol 2065-2A \[Qualitative\]) prior to use in this validation study (Protocol 2065-2A \[Quantitative\]).

This quantitative study will seek to further develop and validate the POMAQ following the general tenants according to the Food and Drug Administration (FDA) Guidance for Industry, Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (FDA 2009) which emphasizes the importance of conducting sound psychometric evaluation of patient-reported instruments through quantitative research methods. However, it should be noted that the POMAQ is not a typical PRO measure capturing a specific latent construct and the specified analytic approach to the POMAQ reflects this difference in theoretical frameworks.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years;
2. Diagnosed chronic pain (≥ 3 months) condition which requires long-term treatment with opioids;
3. Willingness to provide written informed consent; and
4. Able to participate in and complete an Internet-based survey and a telephone interview in English.

Exclusion Criteria:

1. Cognitive or other impairment based on the Principal Investigator's judgment that would interfere with the ability of a participant to complete the validation study
2. Terminal illness with life expectancy \<6 months.
The Effect of Breastfeeding Experience With Virtual Reality Glasses on Breastfeeding Self-efficacy and Motivation

In this study, it was aimed to investigate the effect of breastfeeding experience on breastfeeding self-efficacy and motivation in women with virtual reality simulation. The main question it aims to answer is:

Is breastfeeding experience with virtual reality glasses effective in increasing breastfeeding self-efficacy and motivation? They completed the Socio-Demographic and Pregnancy Information Form and the Prenatal Breastfeeding Self-efficacy Scale. Standard breastfeeding training was given. The application group also experienced breastfeeding with a virtual reality simulation. At the end of the application, they filled out the Prenatal Breastfeeding Self-efficacy Scale again. They completed the postpartum Primiparous Breastfeeding Motivation Scale.

Aim: In this study, it was aimed to investigate the effect of breastfeeding experience on breastfeeding self-efficacy and motivation in women with virtual reality simulation.

Desing: This study is a randomized controlled trial. Method: A total of 52 people were included in the study, 26 in the control group and 26 in the intervention group. They completed the Socio-Demographic and Pregnancy Information Form and the Prenatal Breastfeeding Self-efficacy Scale. Standard breastfeeding training was given. The application group also experienced breastfeeding with a virtual reality simulation. At the end of the application, they filled out the Prenatal Breastfeeding Self-efficacy Scale again. They completed the postpartum Primiparous Breastfeeding Motivation Scale.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women aged 18 and over,
* Which is the primiparous,
* 36. during the week of pregnancy,
* Women whose pregnancy is not in the risky group,
* The person who knows how to read and write,
* Without visual and auditory disabilities,
* There is no breastfeeding barrier,
* Pregnant women who have experienced virtual reality breastfeeding experience and filled out the survey forms completely have been included in the research.

Exclusion Criteria:

* Individuals who did not meet the inclusion criteria were not included in the study.
The Post-operative Analgesia of the Virtual Reality Using a Mirror Therapy After Total Knee Arthroplasty

It was well known that the mirror therapy could decrease pain of upper-limb amputated patients.

The mirror therapy is known to make a plastic change some parts of the brain perceiving the painful body part and modulating its signal by feedback of visual information mirrored with the corresponding contra-lateral normal parts.

In this study, post-operative analgesic efficiency of the virtual reality using a mirror therapy after total knee arthroplasty will be evaluated.

This clinical trial will be performed in the form of prospective, single-blind (i.e. assessor-blind), parallel group, randomized (allocation ratio 1:1), single cohort.


Eligibility Criteria:
Inclusion Criteria:

* patients who were transferred to RM after unilateral TKA

Exclusion Criteria:

* patients cannot freely move the contralat. leg d/t neurologic or musculoskeletal problems
* patients are not enough clear to indicate VAS
* patients cannot look at the virtual reality monitor d/t visual problem
* refusal of the participation
Role of Dietary Fatty Acids in Fatty Liver and Insulin Resistance

The purpose of this study is to investigate whether substituting saturated fats with polyunsaturated fats reduces fatty liver and improves insulin action and other metabolic variables in abdominally obese subjects

Specific goals:

1. Investigate if substituting saturated fats with polyunsaturated fats reduces steatosis and improves hepatic and/or peripheral insulin action in abdominally obese subjects with type 2 diabetes
2. Investigate if changes of lipogenic enzymes in response to dietary fat intervention are associated with changes in hepatic/peripheral insulin sensitivity or liver fat content
3. Investigate potential mechanism of the effects of dietary fatty acids; e.g. gene expression and lipogenic enzyme activity

Eligibility Criteria:
Inclusion Criteria:

* abdominal obese subjects with or without type 2 diabetes
* sagittal abdominal diameter \>25cm

Exclusion Criteria:

* insulin treatment
* history of serious cardiovascular events
* morbid obesity
* claustrophobia (relative criterion)