cyrilzakka/clinical-trials huggingface dataset:
Memory Training in Patients With Amnestic Mild Cognitive Impairment

Preview research reports evidence of cognitive plasticity among individuals with amnestic Mild cognitive Impairment, and small-size studies have suggest that this population can benefit from memory training. This project intends to assess the efficacy of cognitive training in persons with MCI with a randomized controlled design.

The hypothesis is that cognitive training can improve memory performance for persons with amnestic mild cognitive impairment and this improvement can be maintained over time.

Mild Cognitive Impairment (MCI) often represents a transitional state between healthy aging and dementia, being considered a public health problem especially due to the increase of elder population in Brazil and in the World in general. Yet the conclusions of studies on pharmacological treatments for this population are still controversial, making imperative to invest on new efficient therapies such as non pharmacological interventions aimed at memory improvement.

One training mode that has benefited elders is the association between names and faces, which has a compelling clinical relevance considering that one of the main complains among elders is the difficulty in remembering names. However, the exact effects of this kind of training in elders (i.e. the eventual changes in cognition and in brain activation on Magnetic Resonance Imaging) are still unclear.

Therefore, this study aims to verify the effects of memory training (name-face association) compared with control intervention - psychoeducation, in 30 elders with amnestic MCI. We will request the participants with amnestic MCI to submit to a Cerebrospinal Fluid (CSF) in order to improve the accuracy of the diagnosis. Training and psychoeducation will be conducted in 4 sessions (two per week). To assess the effects, we will use cognitive instruments and MRI exams before and after the intervention. Also, one and three months after the conclusion of the training patients will again be submitted to cognitive tests.

Eligibility Criteria:
Inclusion Criteria:

Portuguese as native and preferred language; A minimum of 4 years of education; MRI-compatible; Right-handed individuals; Normal corrected vision and hearing; Estimated intelligence average or above (≥ 80 IQ); Amnestic Mild Cognitive Impairment identified by a doctor and neuropsychological tests; Able to give informed consent.

Exclusion Criteria:

History of neurological disorder; History of serious systemic disease; History of severe mental illness; Current untreated alcohol or substance abuse; Medical conditions that compromise in any way the central nervous system; Presence of visual impairment and / or hearing to preclude cognitive testing; Presence of contraindications to MRI exam; Findings in structural MRI that can interfere with the results of the study.
Chronic Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies

Systemic autoimmune myopathies are rheumatic diseases that affect the striatum skeletal muscles. The transcranial direct current stimulation technique has been frequent, for example, in patients with ischemic stroke or for the optimization of muscular performance in athletes. However, to date, there are no studies evaluating this technique in patients with systemic autoimmune myopathies. Therefore, the main objective of the present prospective, randomized, double-blind, placebo-controlled study is to evaluate the safety and efficacy of the application of chronic transcranial direct current stimulation sessions - associated with aerobic exercises - in the patients with systemic autoimmune myopathies.

Systemic autoimmune myopathies are rheumatic diseases that affect the striatum skeletal muscles. Depending on the clinical, pathophysiological and laboratory characteristics, they may be subdivided into polymyositis, dermatomyositis, antissintetase syndrome, immune-mediated necrotizing myopathy, and among others. Recently, the literature has been presenting better pharmacological treatment options to control these diseases. Despite these advances, this group of diseases still continues to be associated with high morbidity and functional disability, mainly due to the proximal muscular weakness of the scapular and pelvic girdles that may prevent the total recovery of these patients. On the other hand, the association of the transcranial current stimulation technique with motor recovery has been frequent, for example, in patients with ischemic stroke or for the optimization of muscular performance in athletes. However, to date, there are no studies evaluating this technique in patients with systemic autoimmune myopathies. Therefore, the main objective of the present prospective, randomized, double-blind, placebo-controlled study is to evaluate the safety and efficacy of the application of chronic transcranial current stimulation session - associated with aerobic exercises - in patients with systemic autoimmune myopathies.

Eligibility Criteria:
Inclusion Criteria:

* Classification criteria - EULAR/ACR 2017
* Classification critera - Connors et al.

Exclusion Criteria:

* Neoplasia
* Using heart pacemarker
* Using visceral metalic clips
* Infections (HIV, HTLV-1, Hepatitis, etc)
* Pregnance
* Previous historical of convulsions or epilepsies
Protective Effect of Statin Against Negative Cardiovascular Remodeling and Organ Dysfunction After Acute Aortic Syndrome Surgery (PANDA III)

Acute Aortic Syndrome (AAS)/Aortic Aneurysm is a common feature of aortic wall events, including aortic dissection, intramural hematoma, aortic ulceration and aortic trauma, and occurs in up to 35 cases per 100,000 cases per year between the ages of 65 and 75 years. Increased levels of the inflammatory biomarker high-sensitivity C-reactive protein predict cardiovascular events. Since statins lower levels of high-sensitivity C-reactive protein as well as cholesterol, the authors hypothesized that people with acute aortic syndrome but without hyperlipidemia might benefit from statin treatment.


Eligibility Criteria:
Inclusion Criteria:

* (1) Patients with aortic dissection/ulceration/intermural hematoma/aortic aneurysm who underwent aortic arch replacement or endoluminal isolation or hybrid therapy;
* (2) Paitents without clinically significant hyperlipidemia but with cardiovascular disease risk factors (such as male ≥45 years old, female ≥55 years old, hypertension, diabetes, chronic kidney disease, obesity, low HDL cholesterol, smoking, alcohol consumption, family history of early onset ischemic cardiovascular disease) and no previous use of statins;
* (3) Patients are between 18 and 85 years old, male or female;
* (4) Agree to participate in the study and sign the informed consent.

Exclusion Criteria:

* (1) Patients with allergy to statins;
* (2) patients with active liver disease;
* (3) patients with myopathy;
* (4) Lactating women and pregnant women;
* (5) Patients with mental diseases, drug and alcohol dependence;
* (6) Refuse to participate in the study or sign the informed consent.
Low-level Laser Therapy Versus Offloading Exercises on Foot Ulcer Healing in Patients with Type 2 Diabetes

The goal of this clinical trial is to evaluate the effect of extravascular Low-level laser therapy (LLLT) versus offloading exercises on foot ulcers healing (DFUs) in type 2 diabetic patients. could include sixty patients with type 2 diabetes associated with diabetic foot ulcer as a complication, their ages ranging from 45 - 55 years. Patients will be selected from Faculty of Medicine (Kasr Al-Aini) Cairo University. They will be referred by the physician after a complete medical evaluation. . The main question it aims to answer is there any significant difference between extravascular low-level laser therapy and offloading exercise on diabetic foot ulcer healing in type 2 diabetic patients ?

After clinical assessment patients will be randomly allocated into three groups equal in number:

Group (A) (Experimental A): will receive extravascular low level laser therapy LLLT (laser watch device) combined with their prescribed hypoglycaemic medications(oral and insulin) and usual wound care for 12 weeks (3 sessions/ week).

Group (B) (Experimental B): will receive Offloading exercise inform of burger allen exercise combined with their prescribed hypoglycaemic medications(oral and insulin) and usual wound care for 12 weeks (3 sessions/ week).

Group (C) Control group will receive their prescribed hypoglycaemic medications(oral and insulin) and usual wound care only for 12 weeks (3 sessions/ week).


Eligibility Criteria:
Inclusion Criteria:

* Body mass index of 25-34.9 kg/m2.
* Glycated hemoglobin (HbA1c) \&gt;7 %.
* ABP index absolute normal (1-1.3)
* Patient with polyneuropathy.
* Patient suffer from diabetes more than 5 years.
* Patient has chronic unhealed diabetic ulcer from 4 weeks up to 6 weeks.

Exclusion Criteria:

* Patients with history of hypo- hyperglycemic coma.
* Uncontrolled cardiovascular complications.
* Malignancy, Anemia, Hemorrhagic diseases.
* Cardiac peace maker.
* Deep venous thrombosis.
* Osteomyelitis.
* Patients with Monckeberg sclerosis.
* Photosensitivity to laser.
Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet

The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by \> 30% from baseline among patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Eligible subjects must be receiving adequate thrice weekly maintenance hemodialysis with a dialysate calcium concentration ≥ 2.5 mEq/L for at least 3 months prior to screening laboratory assessments
* Subjects must have SHPT as defined by one central laboratory screening predialysis serum PTH value \> 500 pg/mL, measured on separate days within 2 weeks prior to randomization
* Subjects must have one serum cCa value ≥ 8.3 mg/dL obtained before dialysis within 2 weeks of the date of randomization
* Subjects receiving calcium supplements must have no more than a maximum dose change of 50% within 2 weeks before screening laboratory assessments are obtained, and the dose must remain unchanged through randomization

Exclusion Criteria:

* Eligible subjects cannot have received cinacalcet during the 3 months preceding the first screening laboratory assessment
* Other criteria may apply
A Prospective Study Comparing VivAer to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction.

The purpose of this study is to compare the clinical outcomes of the VivAer procedure to functional rhinoplasty and septoplasty surgery for the treatment of nasal airway obstruction (NAO) to establish non-inferiority.

The purpose of this study is to compare the clinical outcomes of the VivAer procedure to functional rhinoplasty and septoplasty surgery for the treatment of nasal airway obstruction (NAO) to establish non-inferiority by using the NOSE scale to evaluate the significance of a patient's nasal obstruction both before and after the procedure for the primary endpoint.

Eligibility Criteria:
Inclusion Criteria:

* Age 22 to 85 years old (inclusively).
* Willing and able to provide consent.
* Willing and able to comply with the patient-specific requirements outlined in the study protocol.
* Has access to a mobile device, tablet, or computer with internet access and has access to an email address.
* Seeking treatment for NAO
* Has a NOSE Score of ≥55 indicating severe to extreme NAO.
* Have a positive modified Cottle maneuver.
* Planning either to undergo an intervention for NAO that includes one of the following as the primary approach.
* VivAer procedure for repair of nasal valve dysfunction (may include inferior turbinate and septal swell body as additional treated areas)
* Functional rhinoplasty surgery addressing the nasal valve and/or lateral nasal wall (may be combined with septoplasty and/or turbinoplasty performed alone or in combination).
* Septoplasty alone or in combination with turbinate reduction.

Exclusion Criteria:

* Has had nasal surgery (including sinus surgery) within the last 3 months.
* Has had a previous rhinoplasty (functional or cosmetic), septoplasty, inferior turbinate reduction, or VivAer procedure to address NAO symptoms.
* Has extreme nasal pathology, a history of extreme nasal injuries, or an abnormal nasal condition (e.g. septal perforation or empty nose syndrome) that may be exacerbated by surgery.
* Has a medical condition(s) that may impair normal healing processes or be exacerbated by the stress of surgery.
* Has chronic rhinitis that is refractory to medications or rhinitis medicamentosa.
* Has poorly controlled chronic rhinosinusitis disease.
* Rhinoplasty is being performed primarily for cosmesis.
* Is receiving, planning to receive, or has received a Latera absorbable nasal implant at any time.
* Planning to have sinus or cosmetic surgery (e.g., functional endoscopic sinus surgery, cosmetic rhinoplasty) or a surgery involving the airway (e.g., hypoglossal nerve stimulation surgery, uvuloplasty, tonsillectomy, tongue base or soft palate interventions) within 6 months following enrollment.
Physical Activity, Weight and Fitness Outcomes in Children in After-Care

The purpose of this study is to compare the effect of two after-school programs on children's physical activity, fitness, body composition, and academic performance.

Tennessee ranks 4th for the highest prevalence of adult obesity in the nation (30.2%), and ranks 5th for the highest rate of youth obesity (36.5%). The Division of General Pediatrics at Vanderbilt has a specific research focus to develop community engagement projects that measurably reduce childhood obesity. Metro Parks and Recreation has been showcased by the National Recreation and Parks Association (NRPA) as a national model for its leadership role in community health and wellness. The two have created a unique academic-community partnership, guided by principals of community-based participatory research (CBPR), that is working to test and disseminate effective Metro Parks-based programs to reduce pediatric obesity. The proposed study will examine the impact of the Coleman Community Center after-school program on routine physical activity, weight and fitness outcomes in children who belong to the low-income and racial and ethnic minority populations at highest risk for childhood obesity. This study was requested by Metro Parks and has significant policy implications: If the program is deemed effective in improving daily physical activity, weight and/or fitness outcomes in students, the proposed study will serve as the rationale to expand the program to Metro Parks' 22 community centers, all of which are located in under-resourced neighborhoods.

Eligibility Criteria:
Inclusion Criteria:

* 5 - 15 years
* enrolled in public school district
* parental permission to access school records

Exclusion Criteria:

* under 5 or over 15
* no parental permission to access school records
Experiences and Needs of Patients, Their Informal Caregiver and Healthcare Professionals Regarding LARS

Exploration of the experiences and needs of patients with the low anterior resection syndrome, their informal caregiver and health care professionals. This is a qualitative study where semi-structured interviews will be conducted with patients and informal caregivers. next to that focus groups will be performed with healthcare professionals from different professions.


Eligibility Criteria:
PATIENTS

Inclusion Criteria:

* adult patients (18+)
* confronted with major low anterior resection syndrome after rectal cancer surgery

Exclusion Criteria:

* stoma at time interview
* abdominal perineal resection

INFORMAL CAREGIVERS Inclusion criteria

* Adults (18+)
* Nominated by the participating patient as their principal caregiver Exclusion criteria None

HEALTHCARE PROFESSIONALS inclusion criteria

* Adults (18+)
* Caring for patients with LARS Exclusion criteria None
Safety and Tolerability Study of SNS-314 for Advanced Solid Tumors

This is a study to assess the safety and tolerability of SNS-314 in advanced solid tumors in humans.

Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the blood).

Eligibility Criteria:
Inclusion Criteria:

* Advanced solid tumor and that is measurable by a scan

Exclusion Criteria:

* Uncontrolled or untreated central nervous system metastases
* Cerebrovascular accident/transient ischemic attack up to 6 months before Cycle 1 Day 1
* Any of the following cardiac conditions:
* History of myocardial infarction, acute coronary syndromes up to 12 weeks before Cycle 1 Day 1
* Class III or IV heart failure up to 6 months before Cycle 1 Day 1
* Baseline heart rate corrected QT interval (QTc)\> 450 msec
* History of ventricular arrhythmias up to 6 months before Cycle 1 Day 1
* Use of medications that prolong the QTc interval and are associated with Torsades de Pointe (TdP)
* Previous cancer treatment up to 21 days before first dose
* Any investigational therapy up to 28 days before Cycle 1 Day 1
* Known allergy to cyclodextrins

Please note: There are additional inclusion/exclusion criteria for this study. Please contact the study center for additional information and to determine if all study criteria are met.
Brazilian Reality of Urinary Bladder Cancers - BRA-BLADDER

A national, multicenter, non-randomized, retrospective, observational study (Real-World Evidence-RWE) aimed at analyzing clinical presentation profiles and demographic characteristics of patients with early urothelial bladder cancer (high-risk non-muscle invasive and localized muscle-invasive) treated with standard therapies in national cancer treatment reference centers within the last 6 years (between 2017 and 2022).

Urothelial carcinoma has several histological types, extensive genetic diversity and a wide array of risk factors related to disease development. Moreover, the treatment effectiveness may be widely impacted by factors such as age, previous comorbidities, socio-economic factors, late diagnosis and access to treatment. In the last decade, the treatment profile has evolved worldwide with the incorporation of new technologies, however, there is no data on Brazilian reality in this period. In a continent-sized country and such heterogeneous health services as Brazil, preparing such knowledge becomes more important and challenging. This paper proposed to describe early urothelial carcinoma presentation pattern and treatment in Brazilian population (high-risk non-muscle-invasive and localized muscle-invasive) in several sites spread throughout the national territory. Thus, data will be generated to provide a more appropriate understanding of the current landscape and, consequently, the better design of public policies to face this disease.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old;
* Diagnosis of high-risk non-muscle invasive urothelial carcinoma, defined as:
* T1 tumor and/or high-grade lesion (G3) and/or presence of CIS.
* Multifocal relapsed tumor and with at least one large lesion (diameter ≥ 3 cm);
* Diagnosis of early muscle-invasive urothelial bladder carcinoma (cT2, cT3 or cT4a N0);
* Consent to participate in the study.

Exclusion Criteria:

* Low-risk non-muscle invasive urothelial carcinoma (single lesion, pTa and low-grade);
* Locally advanced muscle-invasive urothelial carcinoma (suspected lymph node impairment in staging imaging tests) or metastatic at diagnosis;
* Bladder carcinoma with non-urothelial histology (adenocarcinoma, squamous-cell carcinoma or small cell carcinoma);
Treatment of SSRI-Resistant Depression In Adolescents (TORDIA)

The purpose of the study is to determine how best to treat adolescents with depression that is "resistant" to the first SSRI antidepressant they have tried. Participants receive one of three other antidepressant medications, either alone or in combination with cognitive behavioral therapy.

The TORDIA study aims to develop useful clinical guidelines for the care and management of adolescent depression. Adolescents ages 12 to 18, currently taking a prescribed selective serotonin reuptake inhibitor (SSRI) and still experiencing depression, participate in a 12-week randomized treatment study that includes one of four conditions: (1) switching to an alternative SSRI, (2) switching to a different non-SSRI antidepressant, (3) switching to an alternative SSRI and receiving cognitive behavioral therapy (CBT), or (4) switching to a different non-SSRI antidepressant and receiving CBT. This is a double-blind study, which means that neither the participant nor the clinical staff will know which of the three possible medications has been assigned. Participants who respond to the assigned treatment will receive 12 additional weeks of the same treatment. Those who do not appear to be getting better will be offered 12 weeks of an alternative, individualized treatment plan based on each participant's particular needs. All participants will receive follow-up psychiatric evaluations for 12 months after the 12-week continuation phase of the study, regardless of treatment adherence.

Eligibility Criteria:
* between the ages of 12 and 18 years 11 months
* currently in treatment for depression
* taking Prozac,Zoloft, Luvox, Lexapro, Celexa or Paxil (Oregon and Rhode Island sites only)
* still feeling depressed
The Safety, Tolerability And Metabolism Of GSK221149A, In Pregnant Women (30-36 Weeks), In Pre-Term Labor

Pre-Term Labor (prior to 37 weeks gestation) is the largest single cause of infant morbidity and mortality and is frequently associated with long-term disability. Oxytocin is a hormone produced by the body during labor. GSK221149A is an experimental drug that will be used to block the effects of oxytocin, and therefore pause or prevent contractions. In this study, patients with preterm labor will be given an intravenous infusion of GSK221149A over approximately 12 hours followed by an oral tablet in Parts A and B. In part C of this study, patients with preterm labor will be give an intravenous infusion of GSK221149A over approximately 48 hours. The use of a rescue tocolytic is allowed in the study.

A randomized, double-blind, placebo-controlled, dose ranging study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK221149A administered intravenously and to investigate the pharmacokinetics of GSK221149A administered orally to healthy, pregnant females with uncomplicated pre-term labor between 300/7 and 356/7 weeks' gestation

Eligibility Criteria:
Inclusion criteria:

* Healthy pregnant females, 30 -36 weeks pregnant, without ruptured membranes
* 18-45 inclusive
* Symptoms of pre-term labor, (greater than or equal to 6 uterine contractions per hour, each of which at least 30 sec in duration, with cervical dilatation of less than or equal to 4 cm, (measured by tocodynamometry).

Exclusion criteria:

* Any clinically relevant abnormality identified on the screening examination or any other medical condition or circumstance making the patient (mother and/or fetus) unsuitable for participation in the study
* Any clinically relevant pre-existing or pregnancy-related co-morbid condition that may affect maternal pregnancy outcome or neonatal outcome (eg. hypertension, diabetes mellitus, bleeding/clotting diathesis)