cyrilzakka/clinical-trials huggingface dataset:
Statin Effects on Beta-Amyloid and Cerebral Perfusion in Adults at Risk for Alzheimer's Disease

The purpose of the research is to see how simvastatin affects a substance in the body called beta-amyloid. Beta-amyloid is found in the brain and in the liquid around the brain and spinal cord. High amounts of beta-amyloid may be associated with a greater risk of getting Alzheimer's disease. This study will see if simvastatin can lower the amount of beta-amyloid in the spinal fluid. This study will also see if simvastatin affects memory and thinking, blood flow in the brain, and blood vessel function. The investigators hope that future studies show whether simvastatin might prevent memory loss and decrease the chance of developing Alzheimer's disease.

Studies show that some medicines that lower cholesterol may reduce the risk of developing Alzheimer's disease, but this has not yet been proven in humans. We are looking for individuals to participate in this study to see if a cholesterol-lowering medication, called simvastatin affects blood flow to the brain, blood vessel function and a substance in the spinal fluid related to the changes in Alzheimer's disease.

The SHARP study included 88 adults ages 40-72 with parental history of documented Alzheimer's disease. The study had 9 visits over the course of 18 months. Participants had fasting blood tests collected, completed a medical history questionnaire and medication side effect review, underwent lumbar puncture procedure, completed memory testing, and had ultrasound and MRI procedures. Participants were randomly assigned to receive either simvastatin or a placebo each night for 18 months.

Eligibility Criteria:
Inclusion Criteria:

* Parent diagnosed with Alzheimer's disease
* Age 40-72

Exclusion Criteria:

* Active liver disease
* History of adverse reaction to statins
* Contraindication to lumbar puncture
* Elevated creatine kinase and creatinine lab values
* Use of medications known to interact with statins
* History of dementia or mild cognitive impairment
* Currently pregnant or planning to become pregnant
* Use of large quantities of grapefruit juice (more than 1 quart per day)
* Contraindications to MRI (for MRI sub-study)
* Currently on cholesterol-lowering medication or use in past 4 months
* History of heart attack, heart problems, stroke and/or diabetes
* Drinking more than a quart of grapefruit juice per day
* Metal implants, or metal debris in body (MRI)
* List of medications that interact with simvastatin
Evaluation of the Safety and Efficacy of Infantile-onset Pompe Disease Gene Therapy Drug

This study is being conducted to evaluate the safety and effectiveness of GC301 adeno-associated virus vector expressing codon-optimized human acid alpha-glucosidase (GAA) as potential gene therapy for Pompe disease. Patients diagnosed with infantile-onset Pompe disease who are younger than 6 months old will be studied.


Eligibility Criteria:
Inclusion Criteria:

* Age \< 6 months
* Patient has diagnosis of infantile onset Pompe disease
* The patient's legal guardian(s) must be able to understand the purpose and risks of the study and voluntarily provide signed and dated informed consent prior to any study-related procedures being performed.

Exclusion Criteria:

* Left ventricle ejection fraction (LVEF) \< 40%;
* Patient who has AAV9 neutralizing antibody titer ≥ 1:100；
* Patient who has received enzyme replacement therapy (ERT) more than twice;
* Patient who has respiratory dysfunction before enrollment, including the blood oxygen (O2) saturation level \< 90%, or the partial pressure of carbon dioxide (PCO2) in venous blood \> 55 mmHg, or PCO2 in arterial blood \> 40 mmHg;
* Patient who has laboratory abnormalities of: creatinine \> Upper Limit of Normal (ULN), hemoglobin \< 90 g/L;
* Patient with congenital organ absence;
* Patient with a history of glucocorticoid allergy;
* Patient who is positive for human immunodeficiency (HIV) antibody, hepatitis B surface antigen, hepatitis C antibody, or treponema pallidum antibody;
* Patient who has participated in a previous gene therapy research trial;
* Patient who has any concurrent clinically significant major disease or any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in the study.
TIA Scores' Mortality Predictions and Recurrent TIA and Stroke Prediction

Our study adopts a prospective design. Our research aims to determine the significance of ABCD2, ABCD3-I, Canadian TIA Score, and NIHSS Score in predicting the likelihood of ischemic stroke within 30 days in patients presenting to the emergency department with transient ischemic attack (TIA)

Our study is planned as follows: Patients diagnosed with transient ischemic attack (TIA) presenting to the emergency department will undergo scoring by researchers, although they will not intervene the treatment process of the patients. Patients will be contacted by researchers or their families to ascertain whether they experience a recurrent stroke or TIA within 30 days, and their current health status will be assessed. The collected information will be recorded.

The study will include patients diagnosed with transient ischemic attack (TIA) based on tests and imaging conducted at Ankara Etlik City Hospital's emergency department. The planned duration for data collection and analysis is one year.

Parameters to be examined:

Age Gender Physical examination findings Comorbidities (hypertension, coronary artery disease, valvular heart disease, COPD, asthma, diabetes, others) Neurological examination findings Time of symptom onset Admission status (intensive care unit / ward) Findings from ultrasound, computed tomography, and MRI imaging Length of hospital stay Mortality (yes/no)

We aim to collect data from approximately 300 patients within the course of one year for our study

Eligibility Criteria:
Inclusion Criteria:

Patients presenting to the emergency department and diagnosed with TIA Patients diagnosed with ischemic stroke who did not receive thrombolytic therapy based on NIHSS score Patients aged 18 and above Patients who consented by signing the informed consent form

Exclusion Criteria:

Patients diagnosed with hemorrhagic stroke Patients unwilling to participate in the study Patients with a history of trauma Patients unable to receive thrombolytic therapy for any reason (trauma, malignancy, etc.) Patients under the age of 18 Patients transferred from another hospital Patients who experienced cardiac arrest Patients who died for any reason other than ischemic stroke within 30 days Patients wishing to withdraw from the study at any time during the study period
Three-level Network Rehabilitation Model

The objective of this clinical trial was to compare the effects of different interventions on the recovery of stroke patients. The main question it aims to answer are: whether the intervention mode of integrated Chinese and western medicine is more valuable to implement.

Researchers randomly assigned 90 patients to either group A or Group B, 45 in each group. Group A adopted the conventional three-level rehabilitation model; Group B adopted the three-level network rehabilitation model under the medical alliance for rehabilitation treatment with combination of Chinese and Western medicine. Fugl-Meyer motor score was used to assess the patient's motor ability, Berg balance scale was used to assess the patient's balance ability, National Institute of Health stroke scale was used to assess the patient's neurological function, and modified Barthel index was used to assess the patient's ability of daily living.


Eligibility Criteria:
Inclusion Criteria:

* Patients whose primary disease is stroke, whose diagnosis conforms to the "Chinese and Western Medicine Emergency Diagnosis and Treatment Expert Consensus for Acute Ischemic Stroke";
* confirmed by imaging MRI or CT;
* hemiplegia symptoms; clear-headed, able to actively cooperate with the doctor's treatment, the basic vital signs are stable, and the neurological signs basically do not develop.

Exclusion Criteria:

* Patients with lower extremity joint disease, osteoarthritis or ankle joint injury in the past;
* patients with lumbar spine or sacral spinal stenosis in the past;
* patients with previous epilepsy;
* patients with previous history of stroke;
* patients with heart and renal failure;
* Patients who cannot cooperate with treatment.
Building a Community-based Network to Promote Smoking Cessation

This study describes the development of a community-based network to promote smoking cessation among female smokers in Hong Kong.

There is growing concern about the use of tobacco among women in Hong Kong. Nevertheless, nearly all of them reported that they had not attended smoking cessation services provided by the government and other organizations, of which only 6.7% indicated that they would like to attend, demonstrating the need for population-based smoking cessation interventions targeting female smokers in Hong Kong. In response to the increased number of female smokers and their low usage rates of smoking cessation services, the first smoking cessation hotline for female smokers in Hong Kong was established in 2006 by the University of Hong Kong. The aim of this study was to describe the development of a community-based network to promote the smoking cessation hotline among female smokers in Hong Kong.

Eligibility Criteria:
Inclusion Criteria:

* Female Hong Kong Chinese current smokers
* Aged 15 years or above
* Able to speak and understand Cantonese
* Willing to receive face-to-face or telephone counseling

Exclusion Criteria:

* Those who were participating in other smoking cessation programs or services
Efficacy and Safety of Armodafinil for Adults With Excessive Sleepiness Obstructive Sleep Apnea/Hypopnea and Depression

The primary objective of the study is to evaluate whether armodafinil at a target dosage of 200 mg/day is more effective than placebo treatment in improving excessive sleepiness in patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) who have comorbid major depressive disorder or dysthymic disorder.


Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of obstructive sleep apnea/hypopnea syndrome (OSAHS)
* Complaint of residual excessive sleepiness despite nasal continuous positive airway pressure (nCPAP) therapy being effective
* Current or prior diagnosis of major depressive disorder or dysthymic disorder
* Clinically stable with regard to depressed mood and has shown a treatment response to selective serotonin reuptake inhibitor (SSRI) therapy or serotonin and norepinephrine reuptake inhibitor (SNRI) therapy
* Patient has been on a stable monotherapy dose of an allowed SSRI or SNRI for at least 8 weeks at the time of screening
* Women of childbearing potential must use a medically accepted method of contraception.

Exclusion Criteria:

* Confirmed or suspected diagnosis of a currently active sleep disorder other than obstructive sleep apnea/hypopnea syndrome (OSAHS)
* Current episode of major depression that is considered to be treatment-resistant
* A primary diagnosis of: eating disorder, psychotic disorder, delirium, dementia, substance-related disorders, or moderate to severe hypochondriasis
* Patient has a history of bipolar disorder, psychotic depression, schizophrenia, schizoaffective disorder, any other psychotic disorder, or other clinically significant uncontrolled psychiatric condition.
* Patient has a history of homicidal ideation or significant aggression
* Patient has a diagnosis of severe antisocial or borderline personality disorder
* Has a history of significant suicidal ideation, or has current active suicidal ideation, or is considered at imminent risk of self harm.
* Patient has a history consistent with fibromyalgia or chronic fatigue syndrome
* A high consumption of caffeinated products, approximately equivalent to 5 or more cups of coffee per day
* Patient history of any clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction
* Has a past or present seizure disorder
* Patient has a history of alcohol, narcotic, or any other substance abuse or dependence (with the exception of nicotine)
* Psychotherapeutic intervention for the patient was initiated within 8 weeks of the screening visit.
* Patient has known human immunodeficiency virus (HIV)
* Patient has any clinically significant uncontrolled medical condition (including illnesses related to the cardiovascular, renal, or hepatic systems) or surgical condition (treated or untreated)
* Patient is a pregnant or lactating woman
* Patient has previously received armodafinil; or, patient has used modafinil or any investigational product within 28 days of the baseline visit.
Spectroscopic Magnetic Resonance Imaging of Glioma

The study is designed to develop and test new Magnetic Resonance Imaging methods that can improve the characterization of brain cancer and facilitate improved clinical care of these participants.

The primary objective of this study is to develop and test new Magnetic Resonance Imaging methods that can improve the characterization of brain cancer and facilitate improved clinical care of these participants. More specifically, investigators are interested in applying novel spectroscopic and quantitative MR methods that give information beyond what is produced by a clinical brain MRI study and to understand the clinical correlates of the imaging findings. Investigators have tested these sequences in healthy volunteers. The investigators now wish to test these sequences in brain cancer participants in order to understand how these sequences can best be applied in a clinical setting.

To acquire these data, investigators intend to perform additional MRI acquisitions on participants who are scheduled to receive a clinical MRI at the UMN Center for Clinical Imaging Research (CCIR), a facility located at the Center for Magnetic Resonance Research (CMRR). Since these MRIs are required for the participants' clinical care, the participant will not be making additional visits to the CCIR. Based on published data and pilot experiences reported from other institutions, the sequences are well-tolerated. The only imposition for the participant is that the participant will spend additional time in the scanner after completion of the imaging required for clinical care. An informed consent form describing the additional MR sequences performed will be presented to the participant.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women scheduled who are diagnosed with glioma who is seeking clinical care for their conditions at the UMN Masonic cancer center.
2. Passed the safety screen for MRI
3. Age 18 or older
4. Ability to read and understand English
5. Ability to provide informed consent

Exclusion Criteria:

1. Participants who are excluded from the base MRI scan, as determined by the CMRR/CCIR clinical policies are necessarily excluded from this study, as the MRI scan will not be performed.
2. Pregnant women
Turkish Version of Multidimensional Outcome Expectations For Exercise Scale (MOEES

The Multidimensional Outcome Expectations For Exercise Scale (MOEES) was developed to assess the multidimensional outcome expectations of exercise. The Turkish validity and reliability study of the scale, originally in English, has not been conducted before. The aim of this study is to develop the Turkish version of the Multidimensional Outcome Expectations For Exercise Scale (MOEES), and to report its reliability assessment.

The Turkish version of The Multidimensional Outcome Expectations For Exercise Scale (MOEES) will be asked face to face with patients diagnosed with cardiac disease.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years.
* Be diagnosed with heart disease.
* Having at least one of the cardiac risk factors (hypertension, diabetes mellitus, hyperlipidemia/dyslipidemia, overweight or obesity (BMI\>25), physical inactivity (less than 150 minutes of moderate-intensity exercise per week).
* To agree to participate in the study.
* Being able to write and speak in Turkish.

Exclusion Criteria:

* \< 18 years.
* Lack of cooperation.
* No heart disease.
* Mental retardation.
High Frequency Oscillatory Ventilation Versus High Frequency Jet Ventilation for Congenital Diaphragmatic Hernia

The purpose of this study is to conduct a prospective study of all congenital diaphragmatic hernia (CDH) neonates managed at the University of Utah newborn intensive care unit (NICU) and Primary Children's Hospital NICU that required mechanical ventilation at birth. As both high frequency jet ventilation (HFJV) and high frequency oscillatory ventilation (HFOV) are standard approaches to ventilatory support of all neonates including CDH, CDH infants will be randomized at the time of birth or admission to either HFJV or HFOV as initial ventilator mode, stratified by position of the liver in the abdomen or thorax (if known) by 24 hours of age. Measures of oxygenation, ventilation and hemodynamics of the CDH cohort managed on HFOV compared to those on HFJV.


Eligibility Criteria:
Inclusion Criteria:

1. Admitted to either the University of Utah and/or Primary Children's Hospital NICU within 24 hours of birth
2. Requiring mechanical ventilation
3. Umbilical arterial line or peripheral arterial line in place
4. Obtained signed consent
5. Infant is ≤ 24 hours of age

Exclusion Criteria:

1. Severe anomaly

   1. Chromosomal abnormalities
   2. Major congenital anomalies, including cardiac, central nervous system and syndromes
2. Post-natal diagnosis \> 24 hours of life
3. Unable to obtain consent for participation
4. Unable to randomize within 24 hours of life
Comparison of Effectiveness of Home Based Sensory Interventions Along With Standard Therapy Versus Standard Therapy Alone in Autistic Children With Sensory Processing Abnormalities

Around 69-95% of children with Autistic Spectrum Disorder are known to have sensory processing abnormalities .Tackling these problems would help in better quality of life, both for the parents and the children. Sensory integration therapy, an individualized clinic based therapy have been shown to have a positive effect on those children with sensory abnormalities. Hence the investigators are doing this study , to primarily look into the efficacy and feasibility of home based sensory interventions in autistic children with sensory processing abnormalities.


Eligibility Criteria:
Inclusion Criteria:

1. Children between the age group of 3-12years with autistic spectrum disorder as per DSM -V criteria along with CARS and those having sensory abnormalities as screened by short sensory profile 2 will be included in the study group
2. Parents who agreed for home based sensory intervention therapy with strict adherence to same and to refrain from initiation of any new treatments including medications during study period

Exclusion Criteria:

1. Children with epileptic syndromes with language regression(LKS)
2. Children with features of ASD but having underlying structural(TS), neurometabolic or primary epilepsy as etiology
3. Children with uncontrolled seizures (seizures in the last 06 months)
4. Children whose parents do not give consent for the study
5. Children for whom follow up would not be feasible
Polyglactin Sutures Versus Nylon Sutures for Suturing of Conjunctival Autograft in Pterygium Surgery: a Randomised Controlled Trial

To compare the use of polyglactin sutures versus nylon sutures for conjunctival autograft suturing in pterygium surgery.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria included patients with primary nasal pterygium, aged 18 years or older, and able to cooperate surgery under local anaesthesia.

Exclusion Criteria:

* Patients with recurrent pterygium, scarred superior conjunctiva, previous surgery involving the superior bulbar conjunctiva, history of glaucoma, and cicatricial ocular surface disease were excluded
TDCS in Acute Stroke

The purpose of this study is to determine the safety of transcranial direct current stimulation in aphasia therapy in acute and post-acute stroke.

TDCS has been shown to have a positive effect on clinical outcome in both motor rehabilitation and aphasia treatment in chronic aphasic patients. In healthy subjects the method sped up reaction times in naming and language learning tasks. In TDCS a weak current is applied to the subjects head increasing excitatory activity which might lead to improved brain function.

Eligibility Criteria:
Inclusion Criteria:

* first media stroke
* language impairment
* informed consent
* right handedness
* NIHSS \< 20

Exclusion Criteria:

* previous Epilepsy oder epileptogenic events
* epilepsy typical elements in EEG
* hypersensitive skin (head)
* metal implants (head)
* pace maker or other electronic implants
* previous head/brain surgery
* medication reducing seizure threshold
* previous psychiatric events
A WrapAround Case Management Program for Youth Injured by Violence

This is a feasibility study of a WrapAround Case Management Program for Youth Injured by Violence. Youth (aged 10-24) who have been injured by violence and visit the emergency department will be offered a support worker who will provide WrapAround Case Management. This study is designed to assess the feasibility of recruitment, enrollment and follow-up.


Eligibility Criteria:
Inclusion Criteria:

1. Age 10 - 24 and
2. Presentation to an ED or trauma floor with an injury caused by violence (defined as an injury inflicted by someone else and one of a gunshot wound, stab wound, injury due to blunt object, or injury due to bodily force).

Exclusion Criteria:

1. Unable to consent due to language or brain injury,
2. Sexual assault,
3. Child Abuse
4. Self-Inflicted Injury,
5. Subject is under arrest or
6. Non-resident of Winnipeg.
Age-related Changes in Retinal Oxygen Extraction in Healthy Subjects

It has been found that several systemic and ocular diseases are associated with impaired retinal oxygen extraction. In the present study, retinal oxygen extraction will be measured in different age groups in order to identify age related changes in otherwise healthy subjects. In addition, the study will explore short-term changes in retinal metabolism induced by breathing pure oxygen. Measurements will be performed with dynamic vessel analyzer and laser speckle flowgraphy to evaluate retinal blood flow and retinal oxygen saturation, in order to calculate retinal oxygen extraction.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18 and 80 years
* Signed informed consent
* Normal ophthalmic findings, unless the investigator considers an abnormality to be clinically irrelevant for the purpose of the study
* Normal findings in the medical history, unless the investigator considers an abnormality to be clinically irrelevant for the purpose of the study
* Nonsmokers

Exclusion Criteria:

* Abuse of alcoholic beverages or drugs
* Participation in a clinical trial in the 3 weeks preceding the study
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Blood donation during the previous 3 weeks
* Pregnant or breast-feeding women
Pulsed Electromagnetic Fields for Multiple Chemical Sensitivity

The purpose of this study is to determine whether pulsed electromagnetic fields(PEMF) is effective in the treatment of multiple chemical sensitivity in terms of life impact, symptoms, psychological distress, markers of central sensitization and the immune system, and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Lacour's criteria for multiple chemical sensitivity
* Lifestyle or functional impairments that score ≥ 35 on the Life Impact scale of the Quick Environmental Exposure and Sensitivity Inventory
* Signed informed consent

Exclusion Criteria:

* previous PEMF therapy
* psychosis or a comparable disorder
* epilepsy
* cerebral tumours
* leukaemia or malignancies in the head or neck region
* having a pacemaker or other active implants
* pregnancy or nursing
* unreliable contraception
* drug or alcohol abuse
* a pending application or intentions to apply for early retirement
* initiation of pharmacological treatment which have not steadied
* participation in another research study