cyrilzakka/clinical-trials huggingface dataset:
Cardea SOLOTM for Paroxysmal Atrial Fibrillation Diagnosis in ESUS Patients With Left Atrial Enlargement

The aim of the study is to evaluate the efficacy and safety of the Cardea SOLO Compared to 12 lead EKG for Paroxysmal Atrial Fibrillation Diagnosis in ESUS patients with Left Atrial Enlargement.

The Prospective, Multi-center, Open-label, Randomized, Controlled, Investigator-Initiated Trial will be started on June 2022. Randomized patients in two arms will receive Cardea SOLO or 12 lead EKG respectively. Cardea SOLO received patients will keep it for 7 days. 12 lead EKG received patients will discharge home. After 7 days, Results of Cardea SOLO auto reading will be evaluated by dependent committee including cardiologist.

Eligibility Criteria:
Inclusion Criteria:

Inclusion NO. 3 or 4 must be satisfied, and No. 2, 5 and 6 must be satisfied.

2. On the Screening date, Stroke onset date is not over 60 days.

3. ESUS Diagnosis : all of a\~e must be satisfied.

* a. Ischemic stroke detected by CT or MRI that is not lacunar
* b. A person without arteriosclerosis which causes at least 50% stenosis of the intracranial/external arteries supplied to the ischemic site
* c. During continuous monitoring or halter monitoring In the stroke intensive care unit, Person without atrial fibrillation and persistent atrial fibrillation
* d. When checked the Transthoracic echocardiography, No major risk cardioembolic source of embolism. (ex. Myocardial infarction within 4 weeks, mitral stenosis, artificial heart valve and so on)
* e. NO other specific cause of stroke identified(et, arteritis, dissection and drug abuse)

  4. cardioembolism is classified by TOAST classification.

  5. Left ventricle Enlargement(male \>40mm, female \>38mm, LAVI \>35ml/m2

  6. Voluntarily sign the consent form

Exclusion Criteria:

1. Transient cerebral ischemic attack
2. Active cancer
3. Heart embolism, stroke of major heart embolism, stroke high-risk disease
4. Left atrial thrombus
5. Left ventricular thrombus
6. Sick sinus syndrome
7. Myocardiac infarction in 1 month
8. Rheumatic left atrioventricular valve or aortic valve disease
9. Artificial heart valve
10. Myocardiac infarction (EF\<28%)
11. Congestive heart failure (EF\<30%)
12. Dilated cardiomyopathy
13. Nonbacterial thrombotic endocarditis
14. Endocarditis
15. Intracardiac mass
16. Atrial fibrillation
17. Restriction for echocardiography (obesity, lung disease etc)
18. High risk PFO
19. Patch apply difficulty(skin allergy, ulticaria, atopic dermatitis, hyperhidrosis)
20. Implant cardiac pacemaker
21. Life-threatening arrhythmia
22. Radiation therapy or MRI scan
23. Restriction for Cardia SOLO attachment
24. The person who investigator judged unsuitable for the trial
Safety and Efficacy Study of the Z-Lig Medical Device Compared to Allograft

The purpose of this Trial is to demonstrate the safety and efficacy of the Investigational Device for the treatment of ruptured Anterior Cruciate Ligament (ACL) of the knee compared to Allograft.

Current techniques to reconstruct ruptured ACLs utilize either autologous tissue or allograft (cadaver) tissue. Both treatments have well-documented shortcomings (i.e., autologous tissue exposes patients to increased morbidity and allograft tissue use is limited by global availability and quality).

There are currently no effective artificial materials or xenograft tissue substitutes widely available. The purpose of this multicenter clinical trial is to evaluate the safety and efficacy of the Z-Lig in Subjects who require reconstruction of primary ruptured anterior cruciate ligaments and compare those results to allograft.

Eligibility Criteria:
Contact Sponsor
Efficacy and Safety of Telmisartan/Rosuvastatin Co-administration in Hypertensive Patients With Hyperlipidemia

To identify efficacy and safety of Telmisartan/Rosuvastatin co-administration in hyperlipidemia control in hypertensive patients with hyperlipidemia compared to each monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* Men and women \>18 years of age
* Subject who has one of 3 conditions classifed by Cardiovascular Risk Factors, 10-Year Risk, Blood Pressure, LDL-C, Coronary Artery Disease and Equivalent

Exclusion Criteria:

* Female who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study,.
* Other exclusions applied
Therapeutic Effect of Transcranial Magnetic Stimulation on Memory Impairment in Patients After Stroke

The goal of this clinical trial is to test the therapeutic effect of theta burst stimulation (TBS), which is one of stimulus pattern of repetitive transcranial magnetic stimulation, in patients with post stroke cognition impairment (PSCI). The main questions it aims to answer are:

1. To explore the therapeutic effect of TBS to patients with PSCI.
2. To compare effect of TBS with different dose.
3. To explore the mechanism of TBS by functional magnetic resonance imaging (fMRI).

Participants will be asked to do:

1. Treated with TBS and cognitive training for 3 weeks (15 days).
2. Assessed with several scales, including Mini-mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Loewenstein Occupational Therapy Cognitive Assessment (LOTCA), Wechsler Adult Intelligence Scale-revised in China (WAIS-RC), Wechsler Memory Scale (WMS) before and after treatment.
3. Perform the resting fMRI, electroencephalogram (EEG) and event related potential before and after treatment.

Researchers will compare high-dose group, low-dose group and sham group to see if TBS play a role in PSCI and if the effect of high dose TBS was stronger than low dose.

the procedure of study

1. Patients were recruited and agreed with Informed Consent.
2. All patients were assessed with MMSE, MoCA, LOTCA, WAIS and WMS, meanwhile they conduct fMRI and EEG. Target of TBS set at dorsolateral prefrontal cortex (DLPFC).
3. TBS was performed for 15 days (5 days \* 3 weeks).
4. Within 3 days after TBS, all patients were assessed with MMSE, MoCA, LOTCA, WAIS and WMS, meanwhile they conduct fMRI and EEG.
5. Data acquisition and analysis.

Eligibility Criteria:
Inclusion Criteria:

* First-time stroke patients, meeting the diagnostic criteria set by the Fourth National Conference of Cerebrovascular Diseases in 1995, and the course of stroke
* range from 1 to 12 months;
* The vital signs are stable and no progress in neurological signs;
* Education level: Primary school or above, and meeting one of the following conditions: MMSE scale ≥ 10 points, and indicating memory decline, with digit span or delayed memory defects.
* Patients or their family members sign the informed consent form.

Exclusion Criteria:

* Contraindications or high risks for TBS, such as epilepsy, intracranial metal implants, skull repair;
* Contraindications for fMRI, such as metal implants or claustrophobia; refuse fMRI;
* drug/alcohol dependence;
* Cognition or memory dysfunction before the onset;
* Patients who refuse to cooperate, or can't complete cognitive assessment due to other reasons, such as visual and auditory disturbance, aphasia, agnosia, apraxia.
Comparing Clinical Outcomes of Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries

This project consists of a randomized controlled study design. Study candidates will include all patients 18 years or older, who were evaluated at UCSD and found to have an acute ankle syndesmosis injury requiring surgery. Patients who consent to study participation will be randomized to receive one of two standard of care procedures - either a suture button or Fibulink implant. Outcome measures, including the Olerud-Molander and American Orthopaedic Foot and Ankle Society scores, pain, range of motion, time to return to work, and radiographic evaluation will be collected for each participant. Given the potential degenerative changes and poor radiographic and clinical outcomes with inadequate repair of the syndesmosis, it is imperative to evaluate existing and emerging methods of fixation for patients with acute ankle fractures with syndesmosis injuries.


Eligibility Criteria:
Inclusion Criteria:

* Ankle fracture with associated syndesmotic injury requiring surgery
* Age 18 years or older
* Ability to understand the content of the patient information/informed consent form

Exclusion Criteria:

* Any not medically managed severe systemic disease
* Patient preference for specific implant
* Refusal of randomization
* Pregnant patients
* Prisoners
* Participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study
Neuromuscular-Blocking Agents and Hypoxemia During Intubation in Infants (ROC-HYPOX)

The prevention of the occurrence of respiratory events is a constant concern in pediatric anesthesia, as these represent the main cause of the anesthesic mortality. These events occur partly during induction of anesthesia and are all the more frequent as the child is young.

The French recommendations do not propose the use of neuromuscular-blocking agents in pediatric anesthesia. This recommendation is controversial In a recently published study, it has been shown that the use of neuromuscular blocking agents during induction in children under 2 years improves intubating conditions and reduces the incidence of hemodynamic and respiratory events. This monocentric study, centered on intubating conditions, does not allow to conclude on the influence of muscle relaxants on reduction of the respiratory morbidity.

The objective of study is to demonstrate that, in children under 2 years, changing the anesthesia protocol can reduce the incidence and severity of episodes of hypoxemia associated with respiratory events occurring during induction


Eligibility Criteria:
Inclusion Criteria:

* age \<2 years
* indication of general anesthesia with tracheal intubation
* inhalational induction scheduled
* written informed consent of both parents

Exclusion Criteria:

* contra-indication to inhalational induction (full stomach)
* contra-indication to the use of rocuronium
* American Society of Anesthesiologists score (ASA) III or IV
* intracranial surgery
* parental refusal
* absence of affiliation to social security
Anxiety Disorders in Children - Association With Neurodevelopmental Delay/Disorder

The main objective of the study is to examine the relationship between anxiety disorders and neurodevelopmental disorder/delay in children aged 7- 13 years.

Project summary Anxiety disorders (AD's) in childhood are common and may cause great suffering.Childhood AD's may persist into adulthood and knowledge of important risk factors for development and maintenance of these disorders is essential.The development of AD's is due to a complex interaction between biological and environmental factors.This study will examine the relationship between AD's and two biological risk factors:1.Neurodevelopmental delays/disorders (NDD'S) in motor and cognitive function and 2.Temperament/personality.To date a few studies have consistently found that motor impairment is associated with childhood anxiety and predicts persistent anxiety in adolescence.The association between AD's and NDD's in cognitive functions such as language and attention is far less studied. In contrast, there is a huge research literature on temperament as a risk factor for AD's.The temperamental trait "behavioural inhibition" has been shown to be particularly associated with AD's.However, very few studies have examined the interplay between NDD's, temperament and anxiety.The study is a clinical case-control study of children aged 7-13 years with AD's referred to three different out-patient clinics.The participants will be assessed by diagnostic interviews, neuropsychological tests and temperament/personality instruments.Comparison groups are:1.children with ADHD (to compare AD's with another mental disorder related to NDD's) and 2.Non-referred children without a mental disorder. Follow-up at 6 months,1 and 5 years.A pilot study at two of the three out-patient clinics to be included,showed a sufficient sample size.Anticipated implications of the study include increased knowledge of biological risk factors and of latent neurological brain correlates,as well as treatment implications.Children with NDD's are often met with demands they cannot cope with due to their neurodevelopmental immaturity.To adjust the demands to the child's actual level of functioning is important.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of anxiety disorder or ADHD or no diagnosis

Exclusion Criteria:

* Clinical diagnosis of PDD
* mental retardation
* children whose both parents do not speak Norwegian
Improving Heart Failure Care in Minority Communities

For congestive heart failure (CHF) patients with systolic dysfunction, a randomized controlled trial compared nurse-based disease management to address problems in patient and clinician management with usual care for effects on hospitalization and functioning among ethnically-diverse patients in ambulatory practices.

Congestive heart failure (CHF) disproportionately afflicts Black and elderly people, and is a leading cause of hospitalization \> 65 years. Although effective therapies can improve functioning and survival in patients with systolic dysfunction, many may not be receiving the full benefit of existing knowledge, including counseling on self-management and appropriate doses of medications. Patients play a critical role in managing a chronic condition such as CHF, but may not have the skills to do so. Clinicians may not provide counseling or medications consistent with evidence-based guidelines.

Systematic reviews of clinical-behavior change have suggested that interventions targeted to specific problems are more likely to be successful. Based on shortfalls identified in patient self-management and clinical care in Harlem, a predominately non-white area in northern Manhattan, we tailored a nurse-management intervention to address the problems documented, and evaluated its effectiveness in a randomized controlled trial. This trial among primarily-minority patients addresses important gaps in this literature: the study targeted problems documented among CHF patients in Harlem, enrolled patients from ambulatory practices, randomly assigned patients between nurse-management and usual care, and evaluated their subsequent health-related outcomes. Hypothesis: the nurse-management program would result in nurse patients' having fewer hospitalizations and reporting better functioning.

Eligibility Criteria:
Inclusion Criteria:

* • adults \>18 years,

  * systolic dysfunction documented on a cardiac test (echocardiography, radionuclide ventriculography, myocardial stress sestamibi/thallium testing, or left-heart catheterization),
  * English- or Spanish-speaking,
  * community-dwelling at enrollment, and
  * current patient in a general medicine, geriatrics, or cardiology clinic or office at a participating site.

Exclusion Criteria:

* • medical conditions that prevented a patient's interacting with the nurse, including blindness, deafness, and cognitive impairment;

  * medical conditions that required individualized management that might differ from standard protocol, namely pregnancy, renal dialysis, and terminal illness; and
  * procedures that corrected systolic dysfunction, such as heart transplantation.
Onion, Cardiovascular Risk Markers and Gene Expression

AIMS:

The aims are to investigate whether:

* Increased intake of onion (powder) affects plasma lipid profile, blood pressure, indices of insulin sensitivity and blood coagulation.
* Increased intake of onion (powder) affects the expression/activity of enzymes in the defence against foreign substances, e.g. reactive oxygen species, and whether polymorphisms in some of the involved genes may modulate the effect.
* Polymorphisms involved in the metabolism/effect of bioactive components in onion modulate the excretion of metabolites or modulate some of the outcome variables in the study.

Other aims are to try to identify biomarkers for onion consumption in plasma, urine and feces and to investigate whether onion affects the secretion of fat and bile acids.

HYPOTHESES:

The investigators hypothesize that:

* 2 weeks of increased onion intake will improve the plasma lipid profile
* 2 weeks of increased onion intake will increase the metabolism of potentially harmful substances (such as ROS and free radicals) through a change in the expression or activity of certain enzymes.
* That these effects are modulated by common gene variants (polymorphisms)

In a randomized controlled crossover design, participants will receive 2 daily meals with or without onion powder for 2 weeks. Between the two 2-week period is a 4-week wash-out period. One week before and during each intervention period, the participants will be instructed to avoid consumption of onion, garlic and all foodstuffs containing the same bioactive components (polyphenols, sulfur-molecules)as in onion. This includes a number of vegetables and fruits, condiments, tea, chocolate, red wine etc.

Fasting blood samples will be drawn before and after (on 2 separate days) each intervention period, where also weight and blood pressure are measured.

Participants will collect 24-hour urine and feces samples twice before and at completion of each intervention period.

After the fasting blood sampling on the first blood sampling day in each period, participants will receive a test meal (with 10 g onion powder or placebo, i.e. 8.5 g sucrose+ 2 g soy protein isolate). The acute effects will be studied by blood sampling and urine sampling 0, 2, 4 and 24 hours after the test meal.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* BMI 25-40
* No daily medication (except thyroid hormone, stomach acid lowering drugs, mild blood pressure lowering drugs and anti-depressants)
* Not strenuous exercise \>10 hours/week
* No blood donation 3 months before or during the study

Exclusion Criteria:

* Diabetes, CVD, hepatitis, HIV/AIDS
* Cancer or cancer treatment within last 6 months
* Smoking
* Simultaneous participation in other research projects
PIEB vs CEI for Labor Analgesia: An MLAC Study

Utilizing a 'minimal local analgesic concentration (MLAC) study' design to first determine the relative potency of Programmed Intermittent Epidural Bolus (PIEB) compared to Continuous Epidural Infusion (CEI) and secondly to determine the mechanism to explain the potential PIEB efficacy advantage.

Pregnant women who present to Labor and Delivery for an anticipated vaginal delivery will be identified as potential participants based on inclusion/exclusion criteria and their desire for labor epidural analgesia. Once identified, interested candidates will be fully informed of the study procedures, have all questions answered, and informed consent obtained. Pregnant participants will receive a labor epidural upon the patient's request and dosed per protocol to adequate analgesic level.

Patients will be randomized into 1 of 4 groups. Either group I or II in Study Part A and group III or IV in Study Part B in a double-blinded design. Each study part will run in parallel and independently.

Each group will have a varying concentration of bupivicaine infusion; continuous or intermittent bolus administration. In addition each group will have continuous or intermittent bolus administration of sufentanil. These concentrations and forms of administration will be blinded to both the patient and study administrator.

Each epidural infusion concentration and continuous or bolus administration will be determined to be a success or failure based on analgesic scores. The investigators' primary outcome will be the minimal local anesthetic concentration of the final participants in each respective group upon study completion.

DATA SAFETY MONITORING PLAN will follow standard of clinical care. Any adverse events will be reported to the PI and necessary adjustments to the protocol will be immediately instituted.

Eligibility Criteria:
Inclusion Criteria:

* ASA I \& II, Nulliparous and Multiparous, Spontaneous/Induced/Augmented Labor, Early active labor (cervix \<5 cm (if known)), Pain (VPS) \> 3, 18-45 years of age

Exclusion Criteria:

* \<37 weeks gestation, H/o Cesarean Section, Multiple Gestation, Pre-eclampsia, Narcotics within 3 hours prior to labor epidural placement, Chronic Pain (as defined by chronic opiate consumption), Women who are participating in another study that will impact protocol
Virtual Reality and Congenital Diaphragmatic Hernia

The study has been designed to investigate the effect of 12 weeks of using virtual reality based exercises on pulmonary functions, exercise capacity, functional performance, and quality of life in children with surgically-repaired congenital diaphragmatic hernia.

Children with CDH have significant disruptions in their quality of life (QoL) due to their poor health, in this randomized controlled clinical trial, one important aspect of virtual reality is the interactivity of children and their interests in choosing the exercised game. Each child in two groups perform a specific virtual reality based respiratory exercises for 3 months.

Eligibility Criteria:
Inclusion Criteria:

* age between 6 and 10 years.
* BMI was between 20 and 24 kg/m2.
* surgically-repaired congenital diaphragmatic hernia.
* respiratory distress symptoms.
* under follow-up care in pediatric and physical therapy clinic.

Exclusion Criteria:

* Children were excluded if they have growth abnormality.
* neuromotor disorders.
* children with cardiac problems.
* unable to do understand all procedures.
Autonomic and Enteric Profiling

Autonomic, inflammatory, enteric, electrophysiologic and hormonal.

Patients were evaluated by two methods in each of five areas: inflammatory, autonomic, enteric, electrophysiologic, and hormonal.

In part one, patients had similar GI Symptoms regardless of baseline gastric emptying or diabetic/non-diabetic status and all patients demonstrated abnormalities in each of the 5 areas studied.

In part two, patients showed early and late effects of electrical stimulation with changes noted in multiple areas, categorized by improvement status.

Eligibility Criteria:
Inclusion Criteria:

1. Willingness to participate in study and sign informed consent.
2. Age 18 or older.
3. Symptoms of gastroparesis for at least 6 months.
4. Refractory or intolerant to antiemetic drugs.
5. Refractory or intolerant to prokinetic drugs.
6. If Diabetic, documentation of medication for diabetes for at least 6 months.
7. No evidence of anatomic obstruction of GI tract. -

Exclusion Criteria:

1. Previous gastric surgery.
2. History or evidence of rumination syndrome, eating disorder of primary psychiatric disorder.
3. No know collagen vascular disease.
4. Inability or unwillingness to participate in the study.
5. Current active gastric stimulation or other gastrointestinal neurostimulation implant or device.
6. Pregnancy.
Effects of Low Dose Naltrexone in Fibromyalgia

Low Dose Naltrexone (LDN) has been reported anecdotally to reduce the symptoms of Fibromyalgia, a Chronic Multisystem Illness. The drug may work by regulating natural pain-reducing systems. In this study, we will administer both LDN and placebo to a small group of individuals with Fibromyalgia and Gulf War Syndrome, both Chronic Multisymptom Illnesses, to assess the drug's efficacy in treating the condition.

This study will be a placebo-controlled, double-blind, cross-over drug tria. Patients with Primary Fibromyalgia or Gulf War Syndrome will be recruited from the Stanford University Pain Management Center and the surrounding community. Participation in the study will cover 22 weeks. Participants will attend a laboratory session 12 times for progress checkups, and will complete daily measures of symptoms.

Eligibility Criteria:
Inclusion Criteria:

Currently suffering from moderate to severe Fibromyalgia or symptoms of Gulf War Syndrome Age 18-65. Not taking any opioid analgesic Not pregnant or planning to become pregnant.

Exclusion Criteria:

Any known allergy to naltrexone or naloxone. Actual or planned pregnancy.