cyrilzakka/clinical-trials huggingface dataset:
Cognitive Process-based Real-time fMRI Neurofeedback in MDD and Rumination

The purpose of this study is to assess the feasibility and efficacy of real-time fMRI neurofeedback for rumination.

Neuroimaging MRI techniques for measuring brain structure, tissue composition, and Blood Oxygenation Level Dependent functional Magnetic Resonance imaging (BOLD fMRI) will be used to measure task-dependent and task-independent brain hemodynamic and electrophysiological changes in human subjects with major depressive disorders (MDD).

After being informed about the study and potential risks, all participants giving written informed consent will undergo one session of the cognitive process-based fMRI neurofeedback (CNF) targeting the rumination-related brain functional connectivity, and a one-week follow-up. Participants will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to Active (receiving feedback from their own brain activity) or Sham (receiving artificially generated feedback).

Eligibility Criteria:
Inclusion Criteria:

* Good general health
* DSM-5 diagnosis of major depressive disorder (MDD)

Exclusion Criteria:

General Exclusion Criteria:

* Pregnancy

Medical Conditions:

* Moderate to severe traumatic brain injury (\>30 min. loss of consciousness or \>24 hours posttraumatic amnesia) or other neurocognitive disorder with evidence of neurological deficits.
* Presence of co-morbid medical conditions not limited to but including cardiovascular (e.g., history of acute coronary event, stroke) and neurological diseases (e.g., Parkinson's disease), as well as pain disorders.
* Presence of an uncontrolled medical condition that is deemed by the investigators to interfere with the proposed study procedures, or to put the study participant at undue risk.

Psychiatric Disorders:

* Current severe suicidal ideation or attempt within the past 12 months.
* Psychosis
* Bipolar disorder
* Substance abuse or dependence within the previous 6 months

Contraindications for MRI:

* Bodily implants of unsafe paramagnetic materials such as pace-makers and aneurysm clips.
* Claustrophobia that is severe enough to preclude MRI scanning.

Medications:

* Evidence of recreational drug use from a urine test.
Tricuspid RegUrgitaTion Hamburg Cohort

Tricuspid regurgitation (TR) is frequent and has been directly related to high mortality rates. The pathophysiology of TR is mainly functional as it occurs predominantly in the context of left-sided heart disease, pulmonary hypertension, or atrial fibrillation. Surgery is currently the primary treatment option in patients with functional TR. However, isolated tricuspid valve surgery is associated with an intolerable high risk of operative mortality and poor outcomes. New transcatheter options could be used in high-surgical risk patients. However, with often severely dilated annuli with a non-planar and elliptical shape, absence of calcification, and proximity of structures, the tricuspid valve anatomy poses many challenges.

Predictors of outcome are yet to be defined in patients with TR in order to improve risk prediction for the different treatment modalities (medical, surgical, interventional). The Tricuspid Regurgitation Hamburg Cohort (TRUTH) aims to monitor patients with relevant TR, irrespective of the underlying etiology or therapeutic approach. In addition to available evidence from previously published clinical trials, elaborate prospective clinical registries, such as TRUTH, that monitor clinical routine and current practice, will be of significant importance to further enhance therapeutic options.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent in accordance with Good Epidemiological Practice and local legislation.
* Individuals over the age of 18 years.
* Patients with clinically relevant tricuspid regurgitation (≥ severe TR, at least Grade III of V)

Exclusion Criteria:

* Insufficient knowledge of the German language, to understand study documents and interview without translation
* Physical or psychological incapability to cooperate in the investigation
Absolute Quantification in Bone Scintigraphy

While absolute quantification in 18F-FDG PET (Positon Emission Tomography) is widely used in clinical routine, absolute quantification in SPECT (Single Photon Emission Computed Tomography) is under development and its clinical interest remains to be demonstrated. Recent studies carried out on bone scan recordings show the potential interest of quantification indexes such as SUV (Standard Uptake Value).

In oncology, bone scan studies have reported significantly higher SUV values for secondary bone lesions compared with benign osteoarticular lesions , and some have even defined an SUVmax threshold value that points to prostatic bone metastases.

Eligibility Criteria:
Inclusion Criteria:

* Patients with recent vertebral fractures:

  1. who have had at least two SPECT/CT scan scans of the spine as part of a pre-vertebroplasty check-up,
  2. for which fracture dates were known.

Exclusion Criteria:

1. Minor person
2. Person opposing the use of their data (Posters in waiting rooms explaining that the patient must object if they do not wish their data to be used)
Spinal Muscular Atrophy on Wheels, Using Power Mobility

The group of children diagnosed with Spinal Muscular Atrophy (SMA) has serious restrictions on participation. SMA is a neuromuscular disease that leads to neuromusculoskeletal disorders that limit functional activities, sometimes making it impossible to sit down autonomously and to walk.

Scientific evidence has highlighted the importance of implementing physiotherapy interventions in pediatrics that facilitate the integration and participation of children with reduced mobility in their natural environment through the use of different assisted mobility devices that allow the child to acquire a degree of independence and motivation according to their potential and needs.

For some time, with the aim of offering independent movement opportunities for children with severe motor impairment, adapted electric cars have been used, as they are simple to use and easy for the child and family to incorporate into daily tasks within natural environments. These low-cost motorized devices can generate a very positive impact on the participation of children diagnosed with SMA type I from an early age, after training the family and/or the child himself, guaranteeing the maximum possible safety, comfort, motivation and autonomy.

Due to the above, there is a need to carry out the research project defined below, to generate opportunities for the inclusion of children diagnosed with SMA type I through the use of low-cost electric cars that encourage their participation, motivation and quality of life.

OBJECTIVES

1. To know the acceptability of an intervention with motorized mobility through electric cars for young children diagnosed with SMA type I.
2. To check the effectiveness of the motorized mobility intervention with electric cars with respect to: (a) mobility and (b) participation of young children with SMA type I with respect to the control group of children who do not use such devices.
3. To identify the barriers and facilitators of the child's participation in their natural environment of a motorized mobility intervention with electric cars in young children with SMA type I.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of SMA type I
* Ages between 10 months to 5 years.
* No previous experience with motorized mobility.

Exclusion Criteria:

* severe visual problems
* Associated disorders that do not correspond to the diagnosis of SMA type I.
* Families who do not agree to have training in the use of the electric car and continuous monitoring by the corresponding researcher.
"Let's Get Organized" in Adult Psychiatric/habilitation Care

This project aims to evaluate and establish evidence for a novel, group-based intervention that can help people with cognitive limitations due to mental or neurodevelopmental disorders to improve their ability to manage time and organize activities. This might provide an important step towards establishing healthy life habits, getting or maintaining employment, and managing family life. Time management is a necessary skill for maintaining healthy life habits and daily occupations in modern society. People with limited cognitive function due to, for example, mental or neurodevelopmental disorders, have documented difficulties in time management, which is also related to issues with self-efficacy. Common interventions for persons with poor time management are time-assistive devices and products, but studies show that these devices alone are not enough to cover these people's needs. Structured training is needed, but there is a lack of structured interventions to enhance time management skills. The intervention program "Let's get organized" (LGO) is a manual-based group intervention aiming to enhance time management, targeted to persons with mental or neurodevelopmental disorders. In a recent feasibility study the LGO showed promising results.

This project aims to evaluate to what extent the LGO intervention is effective in improving time management, and satisfaction with daily occupations. The proposed project is a randomized-controlled trial carried out in ten psychiatric units in Sweden. Participants (n=104) will be randomly assigned to either LGO group intervention or individual Occupational Therapy intervention for ten weeks .The primary outcome of the study is self-reported time management measured by the Assessment of Time Management Skills. Secondary outcomes are occupational balance, self-efficacy, parental competence and cost-effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* confirmed or suspected diagnosis of a mental disorder, such as affective disorder or schizophrenia, or neurodevelopment disorder, such as autism spectrum disorder or attention deficit hyperactivity disorder/attention deficit disorder
* self-reported difficulties in time management in daily life to an extent that affects functioning in daily life negatively

Exclusion Criteria:

* intellectual disability
AZD8566 Food Effect/Microtracer Study

A study designed to look at how the drug AZD8566 is taken up by the body when given with or without food. In some subjects a comparison will be made with a very small labelled microdose given into a vein.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent
* Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG
* Females who are permanently or surgically sterile or post-menopausal and males

Exclusion Criteria:

* History of any convulsions or seizures
* History of infection or risk of infection due to recent surgery or trauma
* History or presence of conditions know to interfere with the absorption, distribution, metabolism and excretion of the study drug
A Clinical Trial With a New Needle Device Comparing Two Needles for EUS_FNA of Solid Lesions.

Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNA) is a reliable, safe, and effective technique for obtaining samples from the GI wall lesions and from organs adjacent to the GI tract (pancreas, nodes...).Needles available for EUS-FNA include 25G, 22G and 19G. Some studies have suggested that the 25G needle could be equal or even better than the 22G needle.

The BXN system and neddles are is a newly developed for EUS-FNA. This trial is developed for testing the accuracy of the new neddle system for EUS-FNA and for comparing the two needles types, 25G and 22G.


Eligibility Criteria:
Inclusion Criteria:

* endosonographic appearance of a solid lesions
* age \>18 years
* informed consent.

Exclusion Criteria:

* alteration of the coagulation (INR \>1.5, PLT \<50 x 103 /µL)
* inability to express consent
Myocardial Perfusion MRI

The object of this study is to compare four different dosages of Gadavist 1.0 in cardiac Magnetic Resonance Tomography (MRT) imaging with the imaging results of a cardiac SPECT examination in terms of diagnostic quality.

For this purpose Gadavist dosages of 0.01 mmol/kg, 0.025 mmol/kg, 0.05 mmol/kg or 0.1mmol/kg body weight are administered. A study participant receives the respective dose twice i.e. at rest and at stress using Adenosine (which puts circulation into a state of stress similar to that of physical exercise). The time between both injections is 10-15 min.

The total imaging time is about 45 min.


Eligibility Criteria:
Inclusion Criteria:

* Males or females of any ethnic group with reversible focal hypoperfusion in at least 2 adjoining segments in SPECT
* The SPECT examination had been performed within 4 weeks prior to the MRI examination and had been performed for clinical reasons only

Exclusion Criteria:

* Generalized myocardial hypoperfusion (e.g. severe 3 vessel disease)
* Recent myocardial infarction (MI) (within 1 week prior to the study procedure)
* Event that significantly altered cardiac performance between SPECT and MRI imaging, e.g. myocardial infarction, unstable angina, alteration of cardiac medication
* Non-sinus rhythm
* Sinus node disease or symptomatic bradycardia
* Second or third degree atrial ventricular (AV) block
* Complete left bundle branch block (LBBB)
* Known congenital long QT syndrome or a family history of congenital long QT syndrome
* Known previous arrhythmias on drugs that prolong cardiac repolarization
* Uncorrected hypokalemia
* Uncontrolled hypertension (e.g. systolic blood pressure \>185 mm Hg, diastolic blood pressure \>110 mm Hg)
* Baseline hypotension (e.g. mean arterial pressure \<60 mm Hg)
* Ejection fraction below 35%
* Cardiomyopathy, congenital heart defect or higher degree valvular pathology
* Coronary artery stent placement within 4 weeks prior to the MRI procedure
* Previous heart transplantation
Assessment of Left Ventricular Torsion by Echocardiography Study

The purpose of this study is to learn about the twisting or wringing motion of the heartbeat called Left Ventricular Torsion (LV Torsion) which can be seen on ultrasound.

This study is designed to characterize the myocardial torsional behavior in patients with a variety of cardiac pathologies.

Simple and inexpensive methods for measurement of LV torsion could facilitate more widespread investigation of LV torsion, which might reveal significant relationships between torsional alterations and clinical outcomes and eventually lead to routine clinical application. Recently, Doppler tissue imaging (DTI) has been shown to accurately reflect myocardial velocity24,25 with better temporal resolution than MRI.26 Investigators hypothesize therefore that DTI might be used for quantification of LV rotation and torsion of the human heart. The purpose of the present study was to examine the accuracy of a novel method with DTI for quantifying the LV torsion in humans and tagged MRI as the reference standard.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients age 18 to 70 years
* Patients with hypertrophic cardiomyopathy
* Patients with the ability to exercise using a supine bicycle
* Ability to provide informed consent

Exclusion Criteria:

* Aortic valve stenosis classified as moderate to severe
* Severe left ventricular obstruction at rest (high gradients \> 4m/second)
* Uncontrolled arrhythmias including atrial fibrillation, atrial flutter, frequent premature ventricular ectopic beats
* History of sustained ventricular tachyarrhythmia at any time
Cluster RCT of Co-administration Azithromycin, Albendazole & Ivermectin

Cluster-randomised trial comparing co-administration of Azithromycin/Ivermectin/Albendazole with separate administration of Azithromycin and Ivermectin/Albendazole.

The study will be conducted in Beneshangul-Gumuz region, Ethiopia. Within this district, a study group of 8,000 people (in approximately 40 clusters) will receive the azithromycin, ivermectin \& albendazole at a single time. A control group of 8,000 people (in approximately 40 clusters) within the same district will receive the current MDA treatment schedule beginning with Ivermectin/Albendazole followed two weeks later with azithromycin. All drug dosing will be in line with standard FMOH and WHO Guidelines for MDA for trachoma and lymphatic filariasis.

The study will randomly sort subdistrict communities (Gotes) into the trial arm and the control arm. The study will compare the number of adverse events (AEs) and severe adverse events (SAEs) between the two arms to determine if co-administration is not inferior to the standard treatment. The primary outcome will be to demonstrate the safety of the triple-drug administration as measured by incidence of AEs/SAEs following the MDA.


Eligibility Criteria:
Inclusion Criteria:

1. Residing in the community for at least three months;
2. Eligible to receive all three agents according to standard MDA criteria

Exclusion Criteria:

1. Not eligible to receive one or more drugs according to standard MDA criteria;
2. Less than 5 years of age (not eligible for ivermectin)\*\*
3. Pregnant women (azithromycin only, not eligible for albendazole and ivermectin)
4. Lactating women (Only administered azithromycin and albendazole, not eligible for ivermectin)\*\*
5. History of allergies to the drugs being studied (azithromycin, ivermectin, albendazole)
6. Residents who cannot swallow tablets

   * Note that patients that are not eligible for IVM, will receive azithromycin and albendazole. Patients that receive azithromycin and albendazole will be followed up through the same procedure as the triple drug therapy to try to track any AEs attributed to the two drug combination.
Using Feedback Reports to Improve Medication Adherence

The purpose of this research study is to improve statin medication adherence among Veterans with coronary artery disease with poor adherence to medications. The investigators are testing if newer technology pill bottle devices linked with individual feedback and/or social incentive strategies can improve medication taking behavior.

Patients with coronary artery disease and previous poor adherence to statin medications will be recruited at Philadelphia VA Medical Center. Enrolled participants will be randomly assigned to one of three arms:

1. Control Group
2. Individual Alarm device and feedback report
3. Individual plus patient-selected Feedback Friend report

Patients will be given a medication-monitoring device (Vitality GlowCaps) to monitor the statin medication that is being currently prescribed by their primary care physician. In first group, the control arm (Arm 1), the device reminders will be turned off but the device will continue recording adherence to the medications. In second group, reminder arm (Arm 2), the device will be programmed as an alarm that will be activated if the patient does not take the medication at the time set by the patient. In addition the patient will get a weekly report of his/her adherence. In the third group, patient-selected family/friend/or reciprocal peer feedback arm (Arm 3), in addition to the activation of the alarm function the device will be linked to a weekly report on adherence to medications. This report will be delivered to the patient and to the patient identified family/friend/ or reciprocal peer.

Eligibility Criteria:
Inclusion Criteria:

* All participants will have a diagnosis of CAD
* To be eligible they must be between the ages of 30-75 years of age-to ensure we are targeting those most likely to benefit from improving control to these medications
* Patients must have been prescribed a statin by their provider and a documented poor adherence as measured by a 16-month medication adherence rate (Medication Possession Ratio) of \<80%

Exclusion Criteria:

* Due to the use of the medication adherence reminder device, patients must speak English
* Have a home address
* Telephone number
* Be willing and able to identify a friend or family member
* The investigators will exclude atients with active substance abuse, significant hearing loss, or reduced cognitive ability as determined from the patient's problem list
Corticosteroid Injection Versus Nerve Block

The purpose of this study is to evaluate conservative pain relief measures for patients suffering from glenohumeral arthritis or rotator cuff arthropathy. Conservative management of osteoarthritis is often first line treatment, and while a corticosteroid injection is frequently used, suprascapular nerve blocks have not often been described as an analgesic option in this population.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of glenohumeral osteoarthritis, rheumatoid arthritis, or rotator cuff arthropathy who are being offered injection

Exclusion Criteria:

* uncontrolled diabetes (patients will be excluded if no HbA1c within a year or if it is 8 or greater"
* known allergy to steroid or anesthetic
* pregnant women
* prisoners
* patients with diminished capacity to consent to participation
* children under 18 years of age
* non-English speakers
Deep Learning Algorithm for Recognition of Colonic Segments.

The purpose of this study is to develop and validate a deep learning algorithm to realize automatic recognition of colonic segments under conventional colonoscopy. Then, evaluate the accuracy this new artificial intelligence(AI) assisted recognition system in clinic practice.

Colonoscopy is recommended as a routine examination for colorectal cancer screening. Complete inspection of all colon segments is the basis of colonoscopy quality control, and furthermore improves the detection rates of small adenomas. Recently, deep learning algorithm based on central neural networks (CNN) has shown multiple potential in computer-aided detection and computer-aided diagnose of gastrointestinal lesions. However, there is still a blank in recognition of anatomic sites, which restricts the realization of AI-aided lesions detection and disease severity scoring. This study aim to train an algorithm to recognize key colonic segments, and testify the accuracy of each segments recognition as compared to endoscopic physicians.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-70 years undergoing conventional colonoscopy

Exclusion Criteria:

* Known or suspected bowel obstruction, stricture or perforation
* Compromised swallowing reflex or mental status
* Severe chronic renal failure(creatinine clearance \< 30 ml/min)
* Severe congestive heart failure (New York Heart Association class III or IV)
* Uncontrolled hypertension (systolic blood pressure \> 170 mm Hg, diastolic blood pressure \> 100 mm Hg)
* Dehydration
* Disturbance of electrolytes
* Pregnancy or lactation
* Hemodynamically unstable
* Unable to give informed consent