cyrilzakka/clinical-trials huggingface dataset:
Implitapide in Patients With Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-Lowering Therapy

The purpose of this study is to determine if implitapide is effective in lowering triglyceride (TG) levels in patients with Fredrickson Type I or V hypertriglyceridemia where the maximum tolerable medication and diet were not sufficient.


Eligibility Criteria:
Inclusion Criteria:

In order to participate in this study, patients must meet all of the following inclusion criteria:

* be between 8 and 70 years old with diagnosis of Fredrickson Type I or V HTG
* be stable on current maximum tolerated triglyceride lowering therapy
* have a fasting TG level of at least 880 mg/dL (10 mmol/L)
* be male or nonpregnant, nonbreastfeeding female. The women in the study must be surgically sterile, postmenopausal or must practice an effective method of birth control
* must be able to give informed consent or if under the age of 18, parents or legal guardians must give their informed consent
* meet body weight requirements

Exclusion Criteria:

* Recent heart attack, coronary artery intervention, coronary bypass surgery, or stroke.
* Patients with class 3 or 4 heart failure
* Uncontrolled hypothyroidism or other uncontrolled endocrine disease
* Known, clinically significant eye abnormalities, such as cataracts
* History of hepatic disease or AST or ALT levels greater than 1.5 x ULN at Visit 1
* Alkaline phosphatase greater than 2 times ULN
* Serum creatinine greater than 2.0 mg/dL
* Liver cirrhosis and severe liver steatosis
* Clinically significant infection, malignancy, or psychosis
* Use of oral anticoagulants or digoxin unless the dose is stable and is regularly monitored
* Participation in any other investigational study within the last 30 days
* Breastfeeding or pregnant
* Current drug or alcohol abuse
* Serious or unstable medical conditions that would compromise the patient's safety or successful participation in the study
* Unwillingness to comply with study procedures or unwillingness to cooperate fully
Analysis the Relationship Between the Abdomen CT and Outcomes in Acute Urinary Stone Patients

This is an observational study based on retrospectively collected data of ureter stone patients between 2011 and 2014. Aim of study is to determine radiologic findings of non-contrast abdominal computerized tomography as predicting clinical outcomes of suspect ureter stone patients in emergency department (ED).

Gennerally, non-contrast abdominal computerized tomography is a choice of diagnosis for a ureter stone patient.There was no known well of efficacy of CT for predicting the outcomes in ureter stone patient in ED.

Hypothesis of this study are some findings of non-contrast CT may be helpful to predict the clinical outcomes of pain severity (multidose of painkiller), admission and revisit to ED within 5 days after discharge. Investigators analyzed multiple variables including age, sex, initial clinical findings, and various CT findings to assess their association with outcomes; multidose of painkiller in ED, admission at ED and revisit to ED within 5 days.

Eligibility Criteria:
Inclusion Criteria:

* ED Patients
* Age \> 18 years
* Confirmed the ureter stone by Abdomen or Urinary CT

Exclusion Criteria:

* Known a uninary congenital or acquired anomaly
* combined other healthy preblem at the ED

  * infection, renal dysfunction et al
* Known the chronic disease : Hypertension ,Diabetes, Tuberculosis, Malignance et al
Gurney Journey: Virtual Reality Distraction

The aim of this study is to determine whether a software virtual reality (VR) program provided during transportation to anesthesia induction reduces anxiety before the procedure, and compliance in pediatric patients. This study aims to measure the anxiety of patients as they arrive before their procedure, when parting from their parents for transportation to the procedure room, and when anesthesia is provided. Compliance during anesthesia induction will also be monitored. Participants will be randomly placed into to one of two groups. Group 1 will receive standard care from a Certified Child Life Specialist prior to their surgery. Group 2 will receive standard care from a Certified Child Life Specialist and distraction with a novel virtual reality software program.

The aim of this study is to determine whether a novel software virtual reality (VR) program provided during transition from periop to the procedure room and anesthesia induction reduces preoperative anxiety, and induction compliance in pediatric patients. This study aims to specifically monitor and measure the anxiety of patients as they arrive at the preoperative suite, when parting from their parents for transportation to the procedure room, and at induction of anesthesia. Compliance during anesthesia induction will also be monitored. Participants will be randomized to one of two groups. Group 1 will receive standard care during their surgery. Group 2 will receive standard care and distraction with a novel virtual reality software program. We hypothesize that anxiety will be reduced, and anesthesia compliance will improve for participants in Group 2.

Eligibility Criteria:
Inclusion Criteria:

* Ages 5-17 years old.
* Patients undergoing general anesthesia with mask induction for dental procedures.

Exclusion Criteria:

* Cognitive impairment that will impact the use of the VR headset or interaction with the game.
* Participants who cannot comfortably wear the VR headset.
* Visual impairment that would hinder use of software program.
* Patients receiving general anesthesia via IV.
* Parent accompanies patient back for anesthesia induction.
An Open Label, Double-blind Discontinuation Study of Quetiapine Extended Release(XR)

Purpose of Study: To examine 1) the short and long-term effectiveness and tolerability of quetiapine (extended release) XR for the treatment of social anxiety disorder (SAD); and 2) continuation effects of quetiapine XR in preventing SAD relapse.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18-65 years of age
* A primary diagnosis of SAD,using Diagnostic Standard Manual IV(DSM-IV) criteria
* Minimum CGI severity score of 4 and minimum Brief Social Phobia Scale (BSPS) score of 20 at baseline
* Written informed consent
* A negative serum pregnancy test for women of childbearing potential.

Exclusion Criteria:

* Current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder, or cognitive disorder due to a general medical condition
* Any current primary anxiety disorder other than SAD or current primary depression
* History of substance abuse or dependence within the last 6 months
* Suicide risk or serious suicide attempt within the last year
* Clinically significant medical condition or laboratory abnormality
* Women of childbearing potential who are unwilling to practice an acceptable method of contraception
* Subjects needing concurrent use of psychotropic medications
* History of hypersensitivity to quetiapine
* History of cataracts.
A Comparative Study of Mefloquine and S-P as Prophylaxis Against Malaria in Pregnant HIV + Patients

Randomized controlled single blind prospective comparative study.

This study is intended to be a randomized controlled single blind prospective comparative study conducted to compare the efficacy of three, monthly doses of sulphadoxine-pyrimethamine as intermittent preventive therapy with Mefloquine as-intermittent preventive therapy in HIV-infected pregnant women.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant HIV positive patients
* Gestational age 16 weeks and above
* No history of use of Mefloquine or Sulphadoxine
* Pyrimethamine four weeks prior to recruitment.

Exclusion Criteria:

* Anaemia packed cell volume less than 30%
* Pre -existing medical conditions- Diabetes Mellitus, -Hypertension
* Allergy to Sulphadoxine- Pyrimethamine or Mefloquine
* Non-consenting patients
* Multiple gestation
* Known psychiatric illness
* Known seizure disorder
* History of severe renal or hepatic disease
Impact of Increased Parent Presence in the Neonatal Intensive Care Unit on Parent & Infant Outcomes

The purpose of this pilot study is to compare parent and infant outcomes and unit outcomes pre and post a planned unit-wide intervention aimed at increasing parent presence in the Neonatal Intensive Care Unit (NICU). The FCC intervention will consist of communicating an expectation that all NICU parents be present at minimum 4 hours/day versus the current practice of telling families to "come as much as they can" that has resulted in inconsistent parent presence.

Family centered care (FCC) is becoming the standard of care in the Neonatal Intensive Care Unit (NICU) and many benefits of FCC programs are reported in the literature. However, the integration of FCC practices remains inconsistent in NICUs and many families do not fully access available FCC supports. As a result NICU families continue to report feelings of powerlessness, stress, depression and lack of confidence in their ability to care for their infants at home. Studies of increased family presence in the NICU (8hours/day and 24/hours/day) have reported promising results for infants and families, but these studies report on programs implemented outside of the US. It is not known whether a program requiring fewer hours/day of parent presence, which may be a better fit with current US family demographics and policies, would demonstrate similar benefits. The purpose of this pilot study is to compare parent and infant outcomes and unit outcomes pre and post a planned unit-wide intervention aimed at increasing parent presence in the NICU. The FCC intervention will consist of communicating an expectation that all NICU parents be present at minimum 4 hours/day versus the current practice of telling families to "come as much as they can" that has resulted in inconsistent parent presence. Following informed consent, data will be collected on up to 45 NICU infants and families pre- and post- the intervention for a total sample of up to 90. Infant measures will include Salivary Cortisol levels, Infant weight gain, Length of Stay and Feeding route at discharge as well as rates of Family Visiting, Traditional Holding, Kangaroo Care (KC), and Breastfeeding. Parent measures will include Salivary Cortisol Levels and reported stress using the Parent Stress Scale: NICU. Unit-wide data will also be collected pre- and post- the intervention. Unit wide measures will include rates of Visitation, KC, Breastfeeding, Nosocomial Infections, IV infiltrates, Medication Errors and Incident (SERS) report rates.

Eligibility Criteria:
Inclusion Criteria:

* Less than 2 weeks of age
* Must be admitted to NICU

Exclusion Criteria:

* Previously discharged home
* \<28 weeks gestation
* Anticipated hospital stay \> 3 months
Leipzig Exercise Intervention in Chronic Heart Failure and Aging

In both ageing and heart failure progressive exercise intolerance is observed. The Leipzig Exercise Intervention in Chronic heart failure and Aging (LEICA) study aims to investigate how aerobic short-term training interventions affect exercise capacity, left ventricular systolic and diastolic function, biomarkers of heart failure, skeletal muscle metabolism, and endothelial function in chronis heart failure patients (CHF-patients) and healthy subjects (HS) in two different age strata: Above 65 years and below 55 years.

Aim of the trial is therefore to compare the effects of aerobic exercise training in young and old healthy subjects as well as in young and old heart failure patients. To our knowledge this study is the first to prospectively investigate age differences of training responses in both CHF patients and age-matched healthy controls.

Because of the extensive clinical and molecular assessment the results of this trial will be made public in predefined substudies:

* LEICA-Echo
* LEICA-Biomarkers
* LEICA-Endothelium
* LEICA-Cardiopulmonary Exercise Function
* LEICA-Muscle

A total of 60 healthy subjects and 60 heart failure patients (in each group 30 \<55 years, 30 \>65 years) are prospectively randomized to either 4 weeks of aerobic ergometer training or control group.

Before and after the intervention period maximal exercise tolerance is determined by ergospirometry, endothelial function is measured by high-resolution A-mode ultrasound, left ventricular function by echocardiography including tissue Doppler imaging, and thigh muscle mass is assessed by CT. Skeletal muscle biopsies are obtained at both time-points and are analysed for inflammatory cytokines and markers of catabolism/anabolism.

Eligibility Criteria:
Inclusion Criteria:

Group 1: Healthy subjects

* normal left ventricular ejection fraction (EF) \>55%
* normal coronary artery disease (cardiac catheterization)

Group 2: CHF patients

* reduced left ventricular ejection fraction (EF) \<40%
* stable clinical condition (NYHA II-III)

Exclusion Criteria:

* COLD
* cardiac decompensation \<3 months
* ventricular arrhythmias \>Lown IVb
* myocardial infarction \< 4 weeks
* valvular heart disease \>II°
* insulin-dependent diabetes mellitus
* arterial hypertension
* orthopedic conditions prohibiting training participation
Multimodal Neurobiological Approaches to Explore the Gene-Environment Interactions in ADHD

Previous studies have demonstrated significant associations of attention-deficit hyperactivity disorder (ADHD) with monoamine transporter genes, including dopamine transporter gene (DAT1), norepinephrine transporter gene (SLC6A2), and serotonin transporter gene (SLC6A4) as well as the important role of environmental factors in the pathogenesis of ADHD. Hence, investigating how genes and environments interact with each other may contribute to the understanding of the pathophysiological mechanisms of ADHD. In this 3-year project, investigators will explore the complex gene-environment interplay in ADHD with multimodal neurobiological approaches, including neuropsychology, neuroimaging, and metabolites, in order to identify the crucial pathophysiological pathways from genes to the brain.

In the present project, investigators aim to explore the complex gene-environment interplay in children with ADHD to identify the crucial pathophysiological pathways from genes to the brain. To achieve our objective, investigators will use multimodal neurobiological approaches to effectively resolve the four major challenges in exploring gene-environment interactions on ADHD.

1. investigators will use multiple levels of neurobiological approaches to identify the interactions between monoamine transporter genes and environment on ADHD, including neuropsychology, neuroimaging, and neuroactive metabolites in plasma, which will provide larger effects than clinical diagnosis.
2. investigators will employ correlation analyses to test for the presence of correlations between the monoamine transporter genotypes and the environmental factors.
3. investigators will use both categorical (diagnosis of ADHD) and dimensional (inattention and hyperactivity-impulsivity symptoms of ADHD) approaches to assess the interaction effects between monoamine transporter genes and environment.
4. investigators will conduct interactions with ageitems to model more accurately the effects of age, which may be non-linearly related to the neurobiological basis of ADHD.

Eligibility Criteria:
Inclusion Criteria:

* Children or adolescents, between 7 and 16 years of age, must have clinical diagnosis of ADHD according to the DSM-5 diagnostic criteria.
* They have to be medication-naïve. They never receive any medication for the treatment of ADHD.
* They and their parents must understand sufficiently to communicate properly with the investigators.
* They must have a Full-Scale Intelligence Quotient(FIQ) score greater than 80.

Exclusion Criteria:

* They have a major psychiatric comorbid disorder, including schizophrenia, schizoaffective disorder, affective disorders, or autism spectrum disorder.
* They have a past history of seizure, or they are taking antiepileptic drugs.
* They have a past history of substance dependence or abuse, including nicotine, alcohol, amphetamine, or any over-the-counter medication.
* They have a past history of major systemic disease.
* They are using Chinese herbs or health supplements.
Living Well With Lymphoma

In this study the investigators are proposing to evaluate the efficacy, sustainability, and mechanisms of 3 months of individualized counseling of the FRD delivered by registered dietitians, over 8 sessions by phone/video conferencing on fatigue, quality of life, and associated symptoms in persistently fatigued lymphoma cancer survivors compared to 3 months of individualized counseling of the attention control (matched for time and frequency of interactions with the FRD) the General Health Curriculum (GHC). The investigators will randomize and follow 68 lymphoma cancer survivors; accounting for a \~10% drop out rate to achieve a target of 60 patients that will complete the study. The investigators hypothesize that persistently fatigued lymphoma cancer survivors will experience improvements in fatigue, quality of life, and symptoms commonly associated with fatigue, which are then maintained at 15-months post-enrollment; and decreased CRP and alterations in inflammation-associated DNA methylation consistent with reduced inflammation from following the FRD as compared to the GHC.


Eligibility Criteria:
Inclusion Criteria:

* Women and men aged 18 years and older
* Diagnosis of lymphoma (Hodgkin and non-Hodgkin)
* Have an average persistent fatigue defined as ≥ 4 on the Brief Fatigue Inventory
* Fatigue must be attributed to lymphoma diagnosis
* Fatigue onset must be between 12months before diagnosis and any time after diagnosis
* Fatigue must not be attributed to other disease diagnoses
* Fruit and vegetable intake ≤5.5 servings/day
* Have, or be willing to create, an email address to receive study questionnaires electronically.

Exclusion Criteria:

* Medically unstable
* BMI\<18.5 kg/m2
* Have a current untreated diagnosis of mood disorder, e.g., bipolar or major depressive disorder
* Have a current untreated diagnosis of anemia
* Have a current untreated diagnosis of hypothyroidism
* Have an initiation, a cessation or change of treatment of any chronic medications, dietary supplements, behavioral therapy, physical therapy etc., or any planned change of medications, supplements, or therapies during the study
* Have a current diagnoses of cachexia
* Planning on becoming pregnant, currently pregnant or lactating
Brief Cognitive Behavioral Therapy for People with Physical Disabilities

The purpose of this study is to examine the effectiveness of a psychotherapy (non-medication) treatment, Brief Cognitive Behavioral Therapy for Suicide Prevention, in reducing suicide ideation and attempts for people with physical disabilities.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* Disability impacting vision, hearing, or mobility
* Past-week suicidal ideation or past-month suicide attempt

Exclusion Criteria:

* Inability to provide informed consent
* Lack of internet connection and web camera
Sitagliptin Metformin/PPARg Agonist Combination Therapy Add-on (0431-052)

A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin/peroxisome proliferator-activated receptor gamma (PPARg) agonist combination therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patient has type 2 diabetes mellitus
* Patient is inadequately controlled while taking two oral antidiabetic medications

Exclusion Criteria:

* Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
* Patient required insulin therapy within the prior 3 months
* Patient has been taking Byetta (R) (exenatide) within the prior 3 months
Evaluation and Treatment of Adhesive Capsulitis Using Non-invasive Neurostimulation Devices

The goal of this randomized controlled trial is to compare the integrity of somatosensory processing with transcranial magnetique stimulation (TMS) and corticospinal excitability of the affected shoulder in individuals with adhesive capsulitis versus healthy controls.

The secondary objective is to compare the clinical and neurophysiological effects of an intervention using tendon vibration (VIB) to induced kinesthetic illusions. This will involve comparing two groups: one receiving a real intervention versus a placebo intervention protocol, both coupled with standardized exercises in individuals with capsulitis. The hypotheses are that the proprioceptive processing and corticospinal excitability are impaired in the presence of capsulitis, and that the VIB + exercises intervention will result in greater improvements than the placebo VIB + exercises.

To goal is to establish the first empirical foundations for understanding adhesive capsulitis, using cutting-edge neurophysiological investigation technologies.

TMS will be used to explore the presence of maladaptive plasticity in motor networks by assessing the excitability and integrity of the primary motor cortex (M1) and the corticospinal tract.

Recruitement:

30 healthy participants and 30 participants with a diagnosis of adhesive capsulitis will undergo 2 baselines assesments, 6 interventions with tendon vibration and 2 follow-up evaluation. Participants will be age- and sex-matched.

Baseline and follw-up include:

* Questionnaires : SPADI, QuickDASH, French version of the Mcgill Pain Questionnaire;
* Active and passive range of motion;
* Ultrasound for diagnosing capsulitis.

Comparison parameters:

* active motor threshold (aMT)
* Motor evoked potential (MEP) latency and amplitude
* Standardized kinesthetic illusion procedure (SKIP) : direction of illusion, clearness, amplitude/speed.

Interventions :

* 2 baselines including all questionnaires, ultrasound, active and passive range of motion, TMS procedure and SKIP;
* 2 VIB interventions per week, for 3 weeks

  * Real VIB : 80Hz of vibration to induce kinesthetic illusions,
  * Placebo VIB : 40Hz of vibration that does not induce kinesthetic illusions
* 2 follow-up including all questionnaires, ultrasound, active and passive range of motion, TMS procedure and SKIP.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old and over
* Good general health
* Adhesive capsulitis (experimental group) or
* No shoulder pain (placebo group)

Exclusion Criteria:

* Cognitive disorders;
* Any neurological disease/injury affecting the upper limbs;
* History or diagnosis of muscle, tendon, or capsular tear;
* Shoulder surgery/prosthesis;
* Pregnant woman;
* Presence of metal in the skull or jaw;
* History of epilepsy.