cyrilzakka/clinical-trials huggingface dataset:
Mitochondrial Bioenergetics and Role in Cellular Damage in Ischemic Myocardium

Cardiac ischemia is a common pathological condition, known to elicit multiple pathological processes at the cellular level. One of the most affected is thought to be cellular metabolism, key for the adequate cardiac function. The aim is to study mitochondrial bioenergetic function, interaction with other cellular systems and influence of several co-morbidities in myocardium of the affected patients.

Coronary artery disease, one of the most common pathologies in the developed world, causes hypoperfusion of myocardial tissue, usually evident by the presence of anginal pain. This myocardial ischemia elicits alterations in normal cardiomyocyte physiology, which gradually deteriorate cellular function, affecting the performance of the entire organ. The condition is frequently further complicated (and aggravated) by the presence of various co-morbidities, such as diabetes mellitus. The primary aim of this study is to investigate the cardiomyocyte bioenergetics and the consequences of potentially reduced mitochondrial metabolic function in ischemic heart, and evaluate the potential contribution of other conditions, primarily ones affecting metabolic homeostasis.

Eligibility Criteria:
Inclusion Criteria:

* Coronary artery disease
* Indication for coronary artery bypass grafting surgery

Exclusion Criteria:

* Emergency patients
* Patients with LV ejection fraction (LVEF) below 30%
* Patients with severe renal, hepatic or pulmonary disease
Parent Education and Medical Play: A Comparison of Psychological Preparation Strategies for Voiding Cystourethrogram

Hypothesis: The use of parent education and medical play will be able to reduce patient discomfort with potential uncomfortable medical procedures.

Children that have urinary tract infections and those diagnosed with vesicoureteral reflux undergo a procedure called a voiding cystourethrogram (VCUG) to identify and follow vesicoureteral reflux. For many children and parents this can lead to considerable distress. Pre-procedure preparation can potentially reduce anxiety and improve overall experience with the procedure.

Children that are evaluated medically and found to need a VCUG would be eligible for participation in this study. Children would be randomized to having play therapy or a parental education brochure. The study would have no impact on the child recieving the state of the art medical care.

Play therapy involves having the child play through the process of the study with a child life therapist, in an effort to prepare the child for the procedure. Parents/patients will be given a pre and post procedure evaluation form to objectively categorize the parental/patient perception of the experience with the study.

Eligibility Criteria:
Inclusion Criteria:

* Children that have been identified to need a voiding cystourethrogram

Exclusion Criteria:

* Significant medical conditions that preclude child from being able to understand play therapy or have been identified in the past to have so much discomfort from prior studies as to not be able to participate.
High-flow Nasal Oxygenation During Preoxygenation and Atelectasis

Atelectasis after induction of general anesthesia is common even in healthy patients and is clinically problematic, especially in obese patients. We aim to investigate whether preoxygenation with high-flow nasal oxygen during anesthesia induction reduces atelectasis in obese patients.


Eligibility Criteria:
Inclusion Criteria:

* Adults patients undergoinig surgery under general anesthesia with a BMI of 30 kg/m2 or greater who have given informed consent

Exclusion Criteria:

* surgery time less than 2 hours
* Nasotracheal intubation
* Severe cardiac or respiratory disease
* History of difficult airway
* History of a surgery or anatomical anomaly in the head and neck
* History of Inability to breathe through nose
* Gastric reflux disease
Turkish Validity-Reliability Study of the Diabetic Foot Self-Care Questionnaire

The aim of this study is to evaluate the translation, cross-cultural adaptation and psychometric properties of the Diabetic Foot Self-Care Questionnaire in patients with primary Type 2 Diabetes.

This study will be conducted in descriptive type. The population of the research will be patients with diabetic foot in the Endocrinology clinic and polyclinic of the University Hospital. The sample of the study will consist of patients who meet the research criteria and agree to participate in the research. The data collection tools of the study are the patient questionnaire (19 questions), the Diabetic Foot Self-Care Questionnaire (16 questions) and the Foot Care Behavior Scale, by scanning the literature by the researchers.

English Turkish translations will be made before starting the research. Afterwards, expert opinion will be taken for the suitability of the scale items. Then, the Turkish scale items will be translated back into English and the linguist's opinion will be taken that the scale can be applied. Language and content validity will be done for the scale form. The scale items will be translated into Turkish and expert opinions will be taken. Then, the Turkish scale items will be translated back into English and the linguist's opinion will be taken that the scale can be applied. Language validity and content validity will be done in the study. Explanatory Factor Analysis will be applied for the validity of the questionnaire. Kaiser Meyer Olkin(KMO) Test, which measures the adequacy of sample size as antecedent tests, and Bartlett's Test For Sphericity will be used to test sphericity. Factor Analysis Principal Component Analysis Method will be applied.

Eligibility Criteria:
Inclusion Criteria:

* be over 18 years old
* Having Type 2 Diabetes and having a diabetic foot ulcer.
* Volunteering to participate in the research.

Exclusion Criteria:

* Have a communication problem
* Presence of lower extremity amputation
* Presence of any ulcer other than diabetes
Preoperative Hypnosis in Gynecology

The research hypotheses that preoperative formal hypnosis session reduces perioperative anxiety among women undergoing a hysterectomy for pelvic gynecological cancer. The key objective is to estimate the effect of preoperative hypnosis on preoperative anxiety among this population

Anxiety is present preoperatively in 40% of patients. The operated subjects are on average 20% more anxious than the general population, according to a study of 2013. Cancer as well as surgery modifying the body pattern and impairing femininity are risk factors for preoperative anxiety. Recent work in both children and adults has shown that significant levels of preoperative anxiety increase the risk of postoperative complications and the occurrence of postoperative emotional and behavioral disorders. The consequences of hysterectomy increase patients' anxiety, for fear of affecting femininity, and the modification of the body regimen. The prevention of preoperative anxiety in such population is therefore a major issue.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18yrs with pelvic gynecological cancer (endometrium, cervix, ovary),
* at any stage of the disease;
* patient coming for anesthesia consultation before hysterectomy,
* informed signed consent,
* patient affiliated to or beneficiary of social security.

Exclusion Criteria:

* patient \<18yrs,
* patient with a pelvic gynecological cancer that does not require hysterectomy;
* patient with psychiatric history or a depressive syndrome;
* deaf patient (deafness makes the hypnosis session impossible),
* patient under legal protection.
Environments as Smoking Cues: Imaging Brain Substrates, Developing New Treatments (CameraCue)

The overarching goals of this proposal are to 1) identify the network of brain regions specifically activated by personal smoking environment cues and 2) to evaluate the effects of exposure to these cues on smoke self-administration and subjective reactivity. The results of this study will inform the development of novel and more efficacious cue-exposures therapies targeted at helping smokers quit smoking and will provide novel mechanism information regarding the influence of environmental context on drug taking.

The investigator hypothesizes that cue-exposure treatments (CETs), in which drug use is prevented during exposure to drug cues (e.g. lit cigarette) have been of limited efficacy in part because they have not included cues representative of the contexts in which drug use occurs. By demonstrating that context cues have a differential and robust influence on brain and behavioral responses, we will have provided a substantial basis for including such stimuli in the context of treatment. At the same time, we will have identified novel mechanisms by which such stimuli promote continued drug use and relapse.


Eligibility Criteria:
Inclusion Criteria:

* generally healthy
* between the ages of 18 and 55
* smoking an average of 5 cigarettes per day for at least one year
* breath CO (carbon monoxide) level \> 8 ppm (if ≤ 8 ppm, then NicAlert Strip \> 2)
* no interest in quitting smoking for the duration of time required for the experiment
* right-handed as measured by a three-item scale used in our laboratory
* ability to identify 4 personal smoking and 4 personal non-smoking places

Exclusion Criteria:

* inability to attend all required experimental sessions
* significant health problems
* use of psychoactive medications
* use of smokeless tobacco
* current alcohol or drug abuse
* use of illegal drugs as measured by urine drug screen
* current use of nicotine replacement therapy or other smoking cessation treatment
* presence of conditions that would make MRI unsafe (e.g., pacemaker)
Gastric Emptying After Sleeve Gastrectomy

Sleeve gastrectomy (SG) increases gastrointestinal motility, which influences feelings of fullness and satiety. By understanding the differences in gastric emptying (GE) between patients with sufficient weight loss (Total weight loss \[TWL\] \> 35%) and insufficient weight loss (TWL \< 25%), better insight in the aetiology of weight loss after sleeve gastrectomy may be obtained. GE will be measured with scintigraphy and MRI.

Sleeve gastrectomy (SG) increases gastrointestinal motility, which influences feelings of fullness and satiety. Patients' weight loss response on SG varies widely and is difficult to predict. By understanding the differences in gastric emptying (GE) between patients with sufficient weight loss (Total weight loss \[TWL\] \> 35%) and insufficient weight loss (TWL \< 25%), better insight in the aetiology of weight loss after sleeve gastrectomy may be obtained. GE will be measured with scintigraphy and MRI. MRI is a non-invasive imaging method which provides more detailed images of the SG compared to the conventionally used scintigraphy scans.

Eligibility Criteria:
Inclusion Criteria:

* Women aged between 20 and 55 years who underwent sleeve gastrectomy as primary procedure with either TWL \< 25% or TWL \> 35%.
* Patients who had a follow-up period of 2-3 years after sleeve gastrectomy

Exclusion Criteria:

* Maximum BMI \>50 kg/m2
* Patients with a disease known to affect appetite, gastric emptying or gastrointestinal motility
* Patients who are unable to stop medications that affect gastric emptying and/or motility prior to measurements. It is depending on t1/2 for how long they need to stop medication
* Patients who started menopause
* Patients with gastrointestinal problems or, gastric or intestinal diseases
* Patients with a drug or alcohol addiction
* Patients who are unable to stop smoking for 24h
* Patients who are pregnant or lactating
* Patients who have an intolerance or allergy for one of the components of the test product
* Patients who have a contra-indication to MRI scanning
A Study of LY3303560 in Participants With Early Symptomatic Alzheimer's Disease

The purpose of this study is to evaluate the safety and efficacy of a study drug that targets an abnormal protein in the brain found in people with Alzheimer's Disease (AD).


Eligibility Criteria:
Inclusion Criteria:

* Participants must have gradual and progressive change in memory function for \>6 months.
* Participants must have a family member or close friend who is with you at least 10 hours per week and can attend study appointments.

Exclusion Criteria:

* Participants must not have significant neurological disease affecting the nervous system, other than AD, that affects cognition or may affect completion of the study.
* Participants must not have serious or unstable illness that could interfere with the analysis of the study or has a life expectancy \<24 months.
* Participants must not have history of cancer within the last 5 years with the exception of certain types of skin, cervical, prostate, and other cancers that are not likely to recur or spread.
* Participants must not have serious risk for suicide.
* Participants must not have history of drug or alcohol use disorder within the last 2 years.
* Participants must not have multiple severe drug allergies
* Participants must not have HIV, Hepatitis B or Hepatitis C
* Participants must not be receiving gamma globulin (IgG) or intravenous immunoglobulin (IVIG) therapy
Efficacy and Safety of Linperlisib in Relapsed/Refractory Large Granular T Lymphocytic Leukemia

This is a prospective, multicenter, single-arm, phase 2 study. This study aims to evaluate the efficacy and safety of Linperlisib, the PI3K delta inhibitor for patients with relapsed/refractory large granular T lymphocytic leukemia.


Eligibility Criteria:
Inclusion Criteria:

* Male or female age ≥ 18 years
* Diagnosis of T-cell large granular lymphocytic leukemia (T-LGLL)
* Meet any of the following indications for treatment： 1. Hemoglobin \< 100g/L or RBC transfusion dependence 2. Neutrophil count \<0.5×10\^9/L or neutrophil count decreased with recurrent infection 3. Progressive splenomegaly and/or Massive Splenomegaly 4. Combined with autoimmune diseases requiring treatment, such as rheumatoid arthritis, autoimmune thyroiditis, etc. 5. Severe B symptoms
* Failure or intolerance to a first-line therapy
* ECOG performance status ≤2
* Expected survival ≥ 6 months
* Willing and able to comply with the requirements for this study and written informed consent

Exclusion Criteria:

* History of other lymphoproliferative neoplasms
* Had malignant tumor within 5 years before enrollment, exclusive of cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial tumor, cervical carcinoma in situ or other indolent tumors
* Previously received organ or stem cell transplantation
* Patients with active infection within 2 weeks before giving the first dose of medication
* Patients with HBV, HCV, HIV or other infections that require treatment
* History of immunodeficiency, or congenital immunodeficiency disorders
* Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study, including clinically significant cardiac diseases, refractory hypertension, metabolic disorders and other diseases that seriously affect the function of the gastrointestinal tract.
* Abnormal liver function: two consecutive examinations with an interval of ≥1 week suggest that ALT and AST are 2.5 times higher than the upper limit of normal values
* Renal impairment: creatinine clearance \<30ml/min
* History of mental illness
* History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe impairment of lung function, etc.
* Received attenuated vaccine 4 in weeks before enrollment
* Participation in another clinical trial within 4 weeks before the start of this trial
* Have an allergy to Linperlisib or any other part of this medicine.
* Pregnant or breast-feeding patients
* Patients considered to be ineligible for the study by the investigator for reasons other than the above
Influence of Pioglitazone for Renal Transplant Function in Diabetics

The purpose of this study is to test whether pioglitazone is able to prevent the progression of diabetic nephropathy in kidney transplant recipients with diabetes mellitus.

About 30 % of kidney transplant recipients will develop diabetes mellitus. This condition is a risk factor for graft dysfunction, graft loss and increased mortality of patients. Inflammatory reactions within the graft and proteinuria are considered as pathogenetic mechanisms.

Recent studies indicated that pioglitazone might have beneficial effects on the urinary protein excretion of type 2 diabetic patients with diabetic nephropathy and was able to reduce systemic inflammation.

This lead to the hypothesis that pioglitazone could improve proteinuria of kidney transplant patients with diabetes.

Comparison: Effects of pioglitazone vs. placebo on proteinuria and renal function of kidney transplant recipients in a cross over study.

Eligibility Criteria:
Inclusion Criteria:

* kidney transplantation(\> 6 months ago) ; stable graft function
* diabetes mellitus type 2
* acceptable glycemia (HbA1c \< 8%)
* creatinin clearance (MDRD)\>30 ml/min 1,73m²)
* proteinuria \> 30 mg/24 hr

Exclusion Criteria:

* type 1 diabetes
* pregnant or breast feeding women
* congestive heart failure (\>stage 1 NYHA)
* creeping creatinin
* treatment for rejection within 3 months prior to inclusion
* ALT, AST \> 2.5 fold the upper limit of normal
* uncontrolled hypertension
* hypo- or hyperthyroidism
The Microvascular Function of GLP-1 and Its Analogues

Incretins have become a successful drug target in the repertoire of medications used for the treatment of type 2 diabetes. However little is known about a potential benefit of GLP-1 on the vascular system in humans, independent of their glucose lowering actions and data are only derived from ex vivo studies in animals. Particularly little is known about clinically relevant benefits of GLP-1 and its analogues on the microvascular system of individuals with type 2 diabetes.

The vascular effect could be medicated by endogenous GLP-1 (9,36) amide, the breakdown product of GLP-1 (7,36) amide which has a low affinity for the GLP-1 receptor. The investigators hypothesis is that the co-administration of DPP-IV inhibitors will lack the beneficial effects of GLP-1 on the vascular system as GLP-1 (9,36) amide will not be produced by the body.

The study aims to examine the response of GLP-1 and its analogues on small blood vessels and examine the effect of the addition of DPP-IV inhibition in healthy lean individuals, obese individuals and subjects with Type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Lean BMI ≤ 25.0 kg/m2
* Obese BMI ≥30.0kg/m2
* Non diabetic subjects and subjects with Type 2 diabetes on stable medication for at least 3 months

Exclusion Criteria:

* cardiovascular disease
* Raynaud's disease
* current treatment with any anti-hypertensive
* lipid lowering therapies
* severe hepatic impairment
* pregnancy and lactation
* subjects with Type 2 diabetes on insulin therapy
* subjects with Type 2 diabetes on sulphonylureas
* subjects with Type 2 diabetes on incretin based therapies
* subjects with Type 2 diabetes and peripheral vascular disease
* subjects with Type 2 diabetes and history of advanced retinopathy
* subjects with Type 2 diabetes and advanced nephropathy
* subjects with Type 2 diabetes with uncontrolled diabetes (HbA1c \> 8.5%)
Discovering Factors in Narcolepsy Patients' Clinical Research Experiences

An observational trial can provide a platform for patients to share experiences and perspectives on living with narcolepsy, which can inform the development of new treatments and support programs.

Overall, an observational clinical trial is an important tool for advancing the understanding of narcolepsy and improving outcomes for patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years of age
* Patient is able and willing to comply with the treatment/follow-up schedule and requirements
* Patient must provide written informed consent

Exclusion Criteria:

* Women who are pregnant, intend to become pregnant, or are lactating
* Inability to perform regular electronic reporting
* Participants who are vulnerable to any intervention
Heart Failure in Norway: Clinical Characteristics, Mortality and Health Care Resource Use

The prevalence of Heart failure above 70 years of age is 10% and 5 year mortality rate above 60%, higher than for cancer. The readmission rate first after hospitalisation is 44% despite the availability of life prolonging and life quality enhancing treatment. There is a lack of resources for adequate diagnostic workup necessary for implementing evidence-based treatment. This projects aims at assessing the impact of guidelines based diagnostic workup and guidelines based treatment of heart failure on mortality and readmission rates. As the symptoms defining the degree of heart failure and the discharge medication only is available in the electronic patient files, artificial intelligence is used to retrieve this information to assess if treatment is according to guidelines.

The project is using first a rule based text processing approach using IBM Watson, then advancing to a machine learning approach using readmission and mortality as endpoints.

The project has access to digitally stored echocardiographic measurements as well as digital ECG's and lab data on 15 000 patients admitted with a diagnosis of Heart failure. If the retrieval of symptoms and function by artificial intelligence is successful, the next step is to assess if those benefitting the most from echocardiography can be identified using information from the ECG's, lab data or symptoms and functional capacity as described in the Electronic Health Records.


Eligibility Criteria:
Inclusion Criteria: Diagnosis with ICD10 codes as follows; I50.\*, I42.3, I11.\* and COPD J44.\* from 2007 through 2019.

In addition all subjects with NT-proBNP above age specific normal range in same period.

Exclusion Criteria:

none
Clinical and Radiological Evaluation of ACL Reconstruction Results

The study is intended to include all patients who will undergo surgical reconstruction of the anterior cruciate ligament (ACL). The patients will be monitored and evaluated preoperatively and also at 6 months and 1 years after the intervention through a clinical visit. Such assessments will include the patient reported outcomes, the objective examination of the knee during a medical examination to quantify its stability and the radiological examination.

The literature presents a number of studies on the reconstruction of the anterior cruciate ligament, as well as numerous registers, but the identification of factors and parameters determining the outcomes remains largely debated. The study aims to analyze the potentially individual and operative parameters and identify the factors responsible for the clinical and radiological outcomes. In addition to collecting patient data in terms of features and clinical-radiological status, objective data will be documented and correlated.

The study is intended to include all patients who will undergo surgical reconstruction of the anterior cruciate ligament (ACL). These patients will be followed and evaluated preoperatively, at 6 months and at 1 years after surgery during a clinical visit. Such assessments will include the patient reported outcomes, the objective examination of the knee during a medical examination to quantify its stability and the radiological examination.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have provided informed written written consent;
* Patients aged between 18 and 45;;
* Patients undergoing reconstructive surgical treatment of the anterior cruciate ligament (ACL)

Exclusion Criteria:

* Patients who have not signed informed consent;
* Patients undergoing any additional concomitant ligament repair or reconstruction at the same surgery
* Revision procedures
* Patients unable to lay still in an MRI or CT scanner
* Patients with a torn ACL or previous ACL reconstruction in the contralateral knee.