cyrilzakka/clinical-trials huggingface dataset:
The Influence of Oral Vibrational Stimulation on Cognitive Function of Elderly Individuals

The purpose of this study is to investigate the effect of oral vibratory stimulus on the brain activity and cognitive function of elderly people with non-dementia subjects (cognitive normal, mild cognitive impairment)

Evaluating the effect of oral vibratory stimulus on the brain activity and cognitive function of elderly people with mild cognitive impairment

◇ Test design: Open-labeled, prospective, pre-post study

○ Oral vibratory stimulus: As an optimal algorithm drawn through the first year study, the vibratory stimulus is applied 10 times for 15 days (a 5-minute stimulus is applied two times a day for 10 days, and it is composed of repeated 15-second vibratory and 15-second non-vibratory stimulus with a strength of 3.3V).

Eligibility Criteria:
Inclusion Criteria

* A person who has at least 20 natural teeth, including the first molars (including fixed prostheses and implants, excluding removable prostheses)
* A person who has systemic health, including controlled hypertension/hypotension and diabetes patients
* An elderly person who has been diagnosed with normal cognition or mild cognitive impairment in a neuropsychological test and CERAD clinical evaluation (refer to separate inclusion criteria)

Exclusion Criteria

* A person who has medical history of nervous system disease
* A person who is has ever been allergic to resin
* A person who has untreated periodontal disease and/or severely loose teeth
* A person who has a medical treatment history of temporomandibular disorders, who has an occurrence of stomatitis once or more per month within the last 6 months, or who currently has stomatitis
* A person who is receiving or has received treatment for major mental diseases such as dementia, major depression, or mania based on the DSM-IV diagnosis
* A person who has a medical disease that can have a serious effect on cognitive function or is taking related medicine
* A person who has a transplant that is electrically or mechanically operated or a cerebrovascular clip or who has claustrophobia so that an MRI scan is impossible
A Study to Evaluate Mavacamten Impact on Myocardial Structure in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy

The purpose of this study is to evaluate the mavacamten impact on myocardial structure with cardiac magnetic resonance imaging (CMR) in adult participants with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) \[New York Heart Association (NYHA) Functional Class II or III\].


Eligibility Criteria:
Inclusion Criteria

* Diagnosed with obstructive hypertrophic cardiomyopathy (oHCM), in accordance with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines as below:.
* Left ventricular outflow tract (LVOT) peak gradient ≥ 30 mmHg and ≥ 50 mmHg after Valsalva or after exercise.
* Left ventricular ejection fraction (LVEF) ≥ 55% at rest.
* New York Heart Association (NYHA) functional class II or III symptoms.

Exclusion Criteria

* A known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM.
* Documented obstructive coronary artery disease or history of myocardial infarction.
* A history of resuscitated sudden cardiac arrest or life-threatening ventricular arrhythmia within 6 months prior to screening.
* An implantable cardioverter defibrillator (ICD) or pacemaker, or another contraindication for cardiac magnetic resonance imaging (CMR).
* Other protocol-defined inclusion/exclusion criteria apply.
Acute Kidney Injury as a Risk Factor for Myocardial Injury and Ventricular Dysfunction

Acute kidney injury (AKI) is classically described as an abrupt or rapidly reversible reduction in the excretion of nitrogenous waste products, including urea, nitrogen and creatinine. Acute kidney injury definition emphasizes on the filtration function of the kidney, a measure that is unique and easily and routinely measured .

Acute kidney injury is associated with significantly increased resource utilization and health care costs.

Major adverse cardiac events (MACE) after non cardiac surgery are a leading cause of morbidity and mortality. The reported incidence of postoperative myocardial infarction (POMI) among patients undergoing non cardiac surgery is between 3% and 6%.


Eligibility Criteria:
Inclusion Criteria:

* Patients with normal kidney functions and free normal heart functions, were enrolled to this study

Exclusion Criteria:

* patients with chronic kidney disease, cardiac disease, who with minor operations, or emergency, were excluded from the study.
A Prospective Natural History Study in Uveal Melanoma

The overall objective of this proposal is to develop and utilize a multicenter UM registry that will, in a longitudinal fashion, capture prospective data in order to characterize the natural history of UM and provide data that will be used to support the development of novel therapies for this disease. The care of patients with UM requires a multi-disciplinary team of physicians that commonly requires the involvement of both radiation oncology and interventional radiology, and is typically directed by an ophthalmologic oncologist at time of initial diagnosis of primary disease. Overall management is transitioned to a medical oncologist when distant recurrence is identified. In the case that a patient presents with metastasis at the time of diagnosis, a medical oncologist typically directs overall management. The management of surveillance for the development of metastasis following the treatment of primary disease is variable and, if performed at all, is managed by either an ophthalmologic oncologist or medical oncologist. Thus, the successful development of a registry that aims to capture the data regarding the full natural history of UM requires a collaborative effort including leaders from both the UM ophthalmologic oncology and medical oncology fields. To this end, the investigators have built an initial consortium of key ophthalmologic oncology and medical oncology leaders from multiple major UM centers in the United States.

Uveal melanoma (UM) is the most common primary intraocular malignancy in adults, accounting for 85% to 95% of ocular melanoma cases. However, UM represents only about 3% to 5% of all melanomas in the United States (US). UM most commonly arises from choroidal melanocytes (85-90%), but can also arise from the iris (3-5%) and ciliary body (5-8%). The median age of diagnosis is approximately 62; however, the peak range for diagnosis is between 70 and 79. Males have a 30% greater incidence than females. A variety of putative risk factors have been identified, including the presence of light eyes, fair skin, an inability to tan, ocular melanocytosis, dysplastic nevus syndrome, and germline BRCA1-associated protein 1 (BAP1) mutations.

Importantly, there are no recent or on-going multi-center natural history studies being conducted in this disease, and this effort is the only one to be launched with the goal of capturing the complete course of this disease, from diagnosis, initial management, surveillance, and treatment of recurrent disease in a national and international setting. This registry is especially important in providing such needed data.

Eligibility Criteria:
Inclusion Criteria

* Diagnosis of uveal melanoma
* Ability to provide written informed consent for participation in the prospective registry OR an institutional waiver by the IRB/ethics committee for retrospective data collection without written informed consent

Exclusion Criteria

\*None
Use of Mobile-based Technologies to Improve Diabetes Self-management and Postprandial Glucose Control

The project involve evaluation of a web-based nutrition education program and pilot-testing of a new smartphone app for real-time data logging to identify factors causing glycemic variability.

The intervention will be three (3) months in duration and will entail use of a smart phone app for real-time data logging to identify factors causing glycemic variability, as well as use of a web-based nutrition education program. The investigators postulate that the interactive nutrition education curriculum - which will provide feedback to patients about the inter-relationship between their food intake and postprandial glucose profiles, as well as practical guidance for improvements - will lead to a change in food choices and improved post-prandial glucose control.

Eligibility Criteria:
Inclusion Criteria

Individuals that satisfy all of the following conditions will be considered for participation:

1. Must be between the ages of 25 - 75 years of age (inclusive)
2. Type 1 diabetes diagnosis at least 1 year, treated with multiple daily injections or insulin pump.
3. A1c 7.5-9.0%

Exclusion Criteria

1. Current or past use of real-time CGM for more than 2 months.
2. Pregnancy (self-reported) or planning conception in next 6 months.
3. History of disordered eating, actively trying to lose weight or planning to do so, BMI \> 30 kg/m2 (to limit participation by individuals who are actively trying to lose weight),
4. Medical conditions or medications that would affect gastric emptying such as gastroparesis, bariatric surgery, medications such as pramlinitide, liraglutide or exenatide.
Network Connectivity and Temporal Processing in Adolescents Who Stutter

The specific purpose of this clinical trial is to compare performance on rhythm perception and production tasks between children who stutter and children who do not stutter. The overall project also aims to investigate how performance on rhythm tasks may be related to brain activity (non-clinical trial).

Participants in the clinical trial portion of this study will complete rhythm discrimination and finger tapping experiments once a year for 3 years. The study team will compare performance between groups. Participants will also participate in the non-trial portion of the project that includes having magnetic resonance imaging (MRI) each year for 3 years.

Eligibility Criteria:
Inclusion Criteria Children who stutter:

* English as primary language
* Current or past stuttering diagnosis

Inclusion Criteria Children who do not stutter:

* English as primary language

Exclusion Criteria Children who stutter:

* Diagnosed/under treatment for any neurological or psychiatric conditions
* Head trauma with loss of consciousness
* Major medical illness
* Hearing loss- Language/motor delay (below -2 standard deviations on standardized assessments)
* Face, motor, or reflex abnormalities

Exclusion Criteria Children who do not stutter:

* Personal or family history of stuttering
* Diagnosed/under treatment for any neurological or psychiatric conditions
* Head trauma with loss of consciousness
* Major medical illness
* Hearing loss
* Language/motor delay (below -2 standard deviations on standardized assessments
* Face, motor, or reflex abnormalities
Brief Internet Based Treatment for PTSD

The goal of the project is to overcome some of the common barriers to treatment amongst recent survivors of traumatic events, by combining the world of evidence-based intervention with that of modern Internet technology. Specifically, it aims to test the feasibility and effectiveness of an Internet delivery of early-intervention trauma-focused cognitive behavioral therapy (CBT) for preventing post-traumatic stress disorder (PTSD). Over the course of the study the following objectives will be achieved:

1. The development of an Internet-based Virtual Reality intervention for preventing PTSD among patients who have recently experienced a traumatic event.
2. The evaluation of the feasibility of administering this intervention, and
3. The evaluation of the efficacy of this Internet based intervention in the prevention of PTSD in recent trauma survivors.


Eligibility Criteria:
Inclusion Criteria:

* Exposed to a traumatic event that meets DSM Criteria (objectively could cause physical injury;
* Subjectively involves helplessness or fear);
* Aged over 18; Aged under 65;
* Hebrew speaking; Suffering from PTSD (without the time criteria i.e. less than one month of symptoms);
* Able to give informed consent.

Exclusion Criteria:

* Suffering from, or have suffered from in the past, bipolar disorder;
* Suffering from, or have suffered from in the past, psychotic disorder;
* Suffering from, or have suffered from in the past, substance abuse;
* Suffering from PTSD;
* Suffering from another Axis I anxiety disorder that requires immediate treatment;
* Currently presents as a suicide risk, requiring hospitalization.
A Trial Comparing Moxifloxacin Versus Levofloxacin Plus Metronidazole In Uncomplicated Pelvic Inflammatory Disease

To assess the efficacy and safety of oral moxifloxacin compared to oral levofloxacin plus oral metronidazole in uncomplicated pelvic inflammatory disease (PID)


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of uncomplicated PID based on the absence of pelvic or tubo-ovarian abscess at pelvic ultrasound and/or laparoscopic examination.

Exclusion Criteria:

* Subjects with impaired liver and renal function; known hypersensitivity to study drugs, related compounds or any of the excipients.
Glycemic and Metabolic Responses of Frozen Yogurt Containing Saskatoon Berry Powder in Healthy Males and Females

A single site, blinded, randomized, controlled study designed to examine the glycemic and metabolic response of frozen yogurt containing Saskatoon berry powder in healthy males and females.

A single site, blinded, randomized, controlled study designed to examine the glycemic and metabolic response of frozen yogurt containing Saskatoon berry powder in healthy males and females. Eligible participants will be asked to attend 4 in-person clinic visits for comparative testing of the frozen yogurt and frozen yogurt containing Saskatoon berry powder versus white bread. Separate visits for screening and for a fasting blood sample will also be requested (total of 6 visits).

Eligibility Criteria:
Inclusion Criteria:

1. Male, or non-pregnant, non-lactating female, ≥18 and ≤35 years;
2. Normal blood lipid profile, creatinine \<1.5× upper limit of normal (ULN) where the normal range is ≥7 units/L and ≤56 units/L, alanine aminotransferase (ALT) \<2× ULN where the normal range is ≥0.7 mg/dL and ≤1.3 mg/dL, and glycated hemoglobin \<6%;
3. Blood pressure \<140/90
4. Body mass index (BMI) ≥20 and \<30;
5. Stable regime for the past 3 months if taking vitamin and mineral/dietary/ herbal supplements;
6. Agree not to eat Saskatoon berries or foods containing Saskatoon berries while participating in this study;
7. Willing to comply with the protocol requirements;
8. Willing to provide informed consent.

Exclusion Criteria:

1. Not able to consume yogurt or allergies to Saskatoon berries or ingredients in yogurt or bread;
2. Presence of a clinically diagnosed disease affecting the circulatory, respiratory, immune, skeletal, urinary, muscular, endocrine, digestive, nervous or reproductive system that requires medical treatment;
3. Taking any prescribed medication in the last 3 months or supplements that affect gastrointestinal function in the last 3 months;
4. Weight loss of ≥3 kg of body weight within the 6 months prior to enrolling in the study;
5. Current (within the last month) bacterial, viral or fungal infection, or over-the-counter medication within the past 72 hours;
6. Unable to obtain blood samples at the screening or the first study visit.
Anesthesia and Perioperative Neurocognitive Disorders in the Elderly Patients Undergoing Hip Fracture Surgery Platform Trial (ANDES Platform Trial)

Anesthesia and perioperative Neurocognitive Disorders in the Elderly patients undergoing hip fracture Surgery platform trial (ANDES platform trial): A pragmatic multi-arm, adaptive, open label, multicenter randomized controlled platform trial to assess the effect of different enhance anesthesia technique in perioperative neurocognitive function, as compared to standard anesthesia care in the elderly patients undergoing hip fracture


Eligibility Criteria:
Inclusion Criteria:

1. Aged 65 years and older.
2. Patients with unilateral hip fracture (including femoral neck, femoral head, intertrochanteric and subtrochanteric fractures) are scheduled for surgical treatment.
3. American Society of Anesthesiologists (ASA) physical status IV or below.
4. The patients or family members provide written informed consent.
5. Additional inclusion criteria may pertain to specific interventions and will be described in relevant sub-protocols.

Exclusion Criteria:

1. Patients with multiple trauma or fractures (excluding trauma that the researcher judges will not affect the patient's overall recovery, such as simple spinal compression fractures, mild soft tissue contusions, fractures of hands and feet, etc.);
2. Two or more anesthetic surgeries are required.
3. Petients with an obvious history of head trauma (such as loss of consciousness for more than 5 minutes, post-traumatic amnesia, etc.);
4. Patients who the researcher believes are unable to complete the assessment of primary outcome;
5. Additional exclusion criteria may pertain to specific interventions and will be described in relevant sub-protocols.
Exploration of the Deep Transcranial Magnetic Stimulation for Treatment Resistant Schizophrenia

Negative symptoms and cognitive dysfunction are of importance for the prognosis of the patients of schizophrenia. Based on the hypothesis that deep transcranial magnetic stimulation(dTMS) on prefrontal cortex #PFC# could down-regulate the glutamate level of PFC and regulate the functional network in patients with treatment resistance schizophrenia,this research plan to utilise multimodal functional magnetic imaging method(including structural MRI,resting-state functional magnetic resonance imaging and 1H-MRS) to investigate therapeutic efficacy of high-frequency deep transcranial magnetic stimulation on SZ patients symptoms,as well as to elucidate the correlation between treatment effects and glutamate level of PFC

This study includes 87 treatment resistance schizophrenia patients. This study will investigate 1)abnormalities of the glutamate level of PFC in patients with schizophrenia compared to healthy controls by using 1H-MRS technique. 2)potential modulation effects of deep transcranial magnetic stimulation(dTMS) on prefrontal cortex function of patients with schizophrenia. 3)the therapeutic efficacy of dTMS on cognitive impairments and other psychotic symptoms of patients with schizophrenia by adopting cognitive function and psychotic symptoms evaluation,as well as to explore the optimal dTMS treatment pattern on cognitive function.

Eligibility Criteria:
Inclusion Criteria:

* Patients with schizophrenia who meet the dsm-5 diagnostic criteria
* Aged from 18 to 55
* Right-handedness, normal hearing, visual acuity or corrected visual acuity
* Written informed consent of the patient and his/her family
* All patients received MINI 7.0 structured interviews

Exclusion Criteria:

* Patients who are currently taking clozapine or who have failed to respond to a full course of treatment with clozapine
* Current or past neurological illness,severe physical illness,substance abuse or addiction,alcohol dependence,mental retardation,pregnancy or lactation,extreme agitation, stupor, negative suicide,or those who can not cooperate
* Medically unstable for at least 1 month
Digital Psychological Intervention for Pediatric Functional Abdominal Pain Disorders in Primary Care

The project involves researching two psychological treatments for functional abdominal pain in children. The treatments will be offered to children as an early intervention, at primary care level. The study will aim to find out if the treatments are effective and which children the different treatments are effective for.

The research project involves evaluating the efficacy of a collaborative care pathway with a two-level stepped-care model for pediatric FAPD where specialist level community-based pediatric clinics (CPC, Swedish Barn- och ungdomsmedicinsk mottagning) provide consultation and intervention to primary care health centers (HC). As children with FAPD benefit from early intervention, a stepped-care model of delivery at primary care level via a collaborative pathway could potentially be a way to divert more resources to those who need it most. The model explores a collaboration whereby an initial diagnosis of FAPD will be made by a general practitioner at a participating HC, following which digital interventions with two levels, managed by CPC, will be provided. The aim of the study is to explore the effectiveness of the two levels in the stepped-care model, where level 1 involves digitally provided psychoeducation and enhanced information about FAPD, and level 2 is a digitally delivered cognitive behavior therapy (CBT) based psychological intervention for FAPD. The CBT intervention is a fully digital version of the Aim to Decrease Anxiety and Pain Treatment (ADAPT), which has been developed into a Swedish language version through a project funded by the innovation fund in Region Vastragotaland (VGR).

Eligibility Criteria:
Inclusion Criteria:

* Eligible participants are children and young people aged 8-14.
* Diagnosed with functional abdominal pain disorders by their physician.
* Diagnosed at one of the participating primary care health centres.

Exclusion Criteria:

* Children and young people with scores above the clinical cut-off on the Revised Child Anxiety and Depression Scale (RCADS).
* Children who do not follow the mainstream Swedish National Curriculum due to learning disabilities.
Effects of a High-fat Meal on Exercise-mediated Sympatholysis

The goal of this trial is to examine the effects of a single high-fat meal with or without the co-ingestion of dietary nitrate on exercise-mediated sympatholysis. The main questions it aims to answer are:

1. What are the mechanisms responsible for reduced exercise-mediated sympatholysis following a high-fat meal
2. Can dietary nitrate prevent the declines in exercise-mediated sympatholysis

Participants will be asked to complete three study visits in a randomized order:

1. Low-fat meal
2. High-fat meal
3. High-fat meal plus dietary nitrate

Exercise-mediated sympatholysis will be measured using Doppler ultrasound via a protocol involving rhythmic handgrip exercise and a lower body negative pressure stimulus. Sympatholysis will be assessed before each meal, and at 1, 2, and 3 hours post-prandial.


Eligibility Criteria:
Inclusion Criteria:

* 18-30 years of age
* Healthy, free of known cardiovascular, metabolic, or musculoskeletal disease

Exclusion Criteria:

* Diagnosed cardiovascular or metabolic disease, injury preventing handgrip exercise, prescription of chronic medications other than oral contraceptives.
* Inability to abstain from drugs (except oral contraceptives), caffeine, alcohol, strenuous physical activity, mouthwash, and multivitamins prior to study