cyrilzakka/clinical-trials huggingface dataset:
Effects of the Combination of RRT With tDCS on Dyslexic Adults

The purpose of the study is to evaluate the effectiveness of the combination of Rhythmic Reading Training (RRT), a computer-assisted intervention method that combines sublexical reading exercises with rhythm processing, and transcranial direct current stimulation (tDCS) on reading abilities of a group of Italian undergraduate students with dyslexia. Two experimental conditions (active vs. sham) will be compared. Finally, the effects of the intervention on other cognitive functions involved in the process of reading (i.e., rapid automatized naming, verbal working memory, rhythm perception abilities) will be measured.


Eligibility Criteria:
Inclusion Criteria:

* having been diagnosed with DD (ICD-10 code: F81.0) on the basis of standard inclusion and exclusion criteria (ICD-10: World Health Organization, 1992) and of the diagnosis procedure followed in the Italian practice

Exclusion Criteria:

* presence of comorbidity with other neuropsychiatric or psychopathological conditions (whereas comorbidity with other learning disabilities were allowed)
* exclusion criteria for the use of tDCS (e.g. epilepsy, pregnancy).
Safety and Efficacy of Varicella Zoster Immune Globulin (Human) VariZIG in Patients at Risk of Varicella Infection

This study is to assess VariZIG™ for the treatment of patients at risk for developing serious complications from chicken pox.

In most individuals, chicken pox or varicella zoster (VZV) infections are benign; however, in certain at-risk populations such as immunocompromised patients or infants VZV disease can produce significant morbidity and mortality. In such patients, varicella zoster immune globulin (VZIG) has been used to prevent or reduce the severity of VZV infections in at-risk patients exposed to individuals with active infections. Massachusetts Public Health Biologic Laboratories (Boston, MA) has discontinued manufacture of the only FDA approved VZIG product. Cangene Corporation (Winnipeg, Canada) is conducting this expanded access IND protocol for VariZIG™, which is a purified human immune globulin preparation made from plasma of donors with high anti-varicella antibody titers.

This study is an open label, non-randomized, expanded access study that will make VariZIG™ available to eligible patients for whom there is no alternative licensed treatment while a pivotal study is conducted. The study will begin recruiting in February 2006 and will collect safety and basic efficacy data over 42 days following VariZIG™ administration. Physicians will be required to assess measures of varicella infection as well as provide study specific documentation.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.
* Cangene Corporation VariZIG™ release requirement.
* Any of the following at-risk patients exposed to varicella within the previous 96 hours:

  * Immunocompromised pediatric or adult patients.
  * Neonates (less than 1 year of age) and pre-term infants.
  * Pregnant women.
  * Newborns whose mothers had VZV infection shortly before delivery (\< 5 days) or after (\< 2 days) delivery.
  * Healthy non-immune adults

Exclusion Criteria:

* Hypersensitivity to blood or blood products, including intravenous (IV) or intramuscular (IM) human immunoglobulin preparations.
* Selective immunoglobulin A (IgA) deficiency.
* Evidence of VZV infection.
* Evidence of zoster infection.
* Known immunity to VZV(previous varicella infection or varicella vaccination)
* Severely thrombocytopenic ( platelets \< 50 x 10x9 / L )
Accuracy of the Transpatellar Tendon Approach to Knee Arthrocentesis

The purpose of this study is:

* To determine the accuracy of intraarticular placement with the transpatellar tendon approach as compared to the suprapatellar approach. Patients undergoing knee arthroscopy will be consented for study of the injection of the fluid into the joint prior to portal placement or commencement of knee replacement. Patients will be randomized to receive injections via the transpatellar tendon or superolateral approach. Using injectable contrast and fluoroscopy, the placement of injections into the knee will be evaluated for accuracy. Injection attempts with contrast fluid that uniformly coats the articular surface on sagittal and coronal radiographs will be counted as successful. A concentration of contrast fluid in extraarticular fat will be counted as a failure.

Hypothesis: The rate of accuracy of intraarticular placement of the needle tip via the transpatellar tendon approach to knee aspiration is greater than that of the superolateral approach.

* To determine the distribution of contrast material with the transpatellar tendon and superolateral apporaches. Using a previously described evaluation technique of dividing the knee into seven compartments, sagittal and coronal fluoroscopy images will be evaluated to determine the distribution of contrast fluid.

Hypothesis: Contrast injected into the knee via the trasnpatellar tendon approach will penetrate as many compartments of the knee as contrast injected via the superolateral approach.


Eligibility Criteria:
Inclusion Criteria:

* undergoing elective arthroscopic surgery of the knee
* age greater than 18 years old and less than 80 years old
* able to consent to a research study

Exclusion Criteria:

* allergy to contrast dye, iodine or shellfish
* currently pregnant
* acute fracture or dislocation
Effect of Word Characteristics and Orthography on Vocabulary Learning

The purpose of the study is to investigate how word characteristics (e.g., phonotactic probability) and orthography affect vocabulary by children with low oral language levels. The investigators will use a 2 x 2 within-subjects factorial design where every participant receives the treatment. This 12-week study aims to improve vocabulary learning efficiency for children with low oral language levels. The study's findings will uniquely contribute to the field in that this is the first research study using real words instead of nonwords while combining word learning research with vocabulary learning.

The investigators are proposing a vocabulary intervention that analyzes word sounds and sound segments. This analysis offers valuable insights into how children at risk for specific learning disabilities, such as dyslexia or speech and language impairments, learn words differently from typically developing children.

Eligibility Criteria:
Inclusion Criteria:

Score of 85 or lower on the Clinical Evaluation of Language Fundamentals - CELF (4) Enrolled in or just completed third grade.

Exclusion Criteria:

Any diagnosis of sensory impairments A diagnosis of autism or traumatic brain injury
Clinical Characteristics and Associations of the "Good Fontan" Patient

This study aims to determine what are some of the clinical characteristics and associations of Fontan patients who are doing well, as well as how accurate cardiology providers are at predicting the likelihood of future adverse event in their Fontan patients.

This is a multi-center prospective study that involves collecting data from patients as well as their cardiology providers in order to determine whether there is correlation between patient-reported quality of life assessments and clinician-identified assessments of their patients. The study also involves collecting data from the medical records of participating patients and entering it into our study database.

Eligibility Criteria:
Inclusion Criteria:

* Extracardiac or Lateral Funnel Fontan

Exclusion Criteria:

* Currently being evaluated for or listed for cardiac transplant
* Underwent Fontan revision or conversion
* Currently pregnant
Mechanisms of Anaphylaxis

The purpose of this study is to explore different mechanisms for anaphylaxis and find novel biomarkers for this hypersensitivity syndrome. The study participants are patients with anaphylaxis, patients with mild allergic reactions, and patients with febrile transfusion reactions. The investigators will also include a group of healthy controls.


Eligibility Criteria:
Inclusion Criteria:

According to the specific cohort:

1. Diagnosis of anaphylaxis
2. Mild allergic reaction
3. Febrile transfusion reaction
4. Healthy, no known allergic disease

Exclusion Criteria:

Suspicion or diagnosed sepsis Children
Muscle Pressure in the Flank Position

Using healthy volunteers, participants will lay on an operating room table in various positions employed during kidney surgery. Using a pressure sensor mat, we hope to determine which areas of the body are subject to higher pressures. Using padding devices (foam, gel, water mattress)which are currently used in the operating room will be employed and measurements will be taken to determine which padding material and configurations is optimal to reduce the pressure to those body parts at risk for excessive pressure subject during laparoscopic surgery.


Eligibility Criteria:
Exclusion Criteria:

* Subjects with musculoskeletal disabilities
Accuracy of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic Cancer

In recent years, template guidance has been applied and developed in the field of puncture related operations, such as template-assisted radioactive seed implantation. With the guidance of template, needle pathway of seed implantation, biopsy and fiducial marker implantation can be precisely planned actual operation, which is conducive to the accurate proceeding. Templates can be divided into coplanar templates and non-coplanar templates. The digital coplanar template coordinate puncture system has been developed in China and has been applied in clinical practice.

In previous studies, coplanar template assisted CT-guided radioactive seed implantation has good clinical feasibility for head and neck cancer. However, the accuracy of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic cancer are lacking in prospective studies. The study aims to prospectively observe the accuracy and safety of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Ages 18 to 85
2. Single or multiple abdominal or pelvic tumors (solid, partially solid)
3. Without taking drugs affecting coagulation and/or platelet aggregation are used; If used, the drug has been discontinued for a sufficient period of time (e.g. 1 week)
4. KPS\>60 points with expected survival \>3 months, no serious or uncontrolled underlying diseases, clinical evaluation patients can tolerate puncture
5. Planned seed implantation with applicable puncture path
6. With informed consent.

Exclusion Criteria:

1. Poor organ function (e.g. Liver decompensation)
2. The lesion close to blood vessels and intestine, or there is portal vein hypertension and superior vena cava compression, etc., which are expected to have high risks of puncture bleeding and intestinal injury
3. Poor compliance, unable to complete coordination
4. Paticipant who is considered inappropriate or unwilling to participate in this clinical trial for other reasons.
Bioequivalence Study Between "Dong-A Atorvastatin Tab" and "Lipitor Tab"

An Open-Label, Randomized, 2-sequence, 4-period, Fasting Condition, Single-dose, Per Oral, Cross-over Study to Evaluate the Bioequivalence between "Dong-A Atorvastatin 80mg Tab" and "Lipitor 80mg Tab" in Healthy Volunteers

1. Study design: An open-Label, randomized, 2-sequence, 4-period, fasting condition, single-dose, per oral, cross-over study
2. Administration method:

   The subject should maintain a minimum of 10 hours of empty stomach before administration, and give an oral dose of 1 tablets (Dong-A Atorvastatin 80mg or Lipitor 80mg) with 150 mL of water at around 8 a.m. on the day of the test. The subject should not chew or break the drug, but should swallow in whole with water. The difference in administration time between the test subjects is about one minute apart, considering the blood collection time.
3. Wash out period: at least 7 days
4. Blood collection time: Before the administration, 0.17, 0.33, 0.5, 0.75, 1, 1.33, 1.67, 2, 3, 4, 6, 8, 12, 24, 36 hr after the administration (total 16 times)
5. Analysis: Measurement of the concentration of an unchangeable substance of Atorvastatin in plasma

Eligibility Criteria:
Inclusion Criteria:

1. A person who aged 19 or older at the time of screening
2. BMI of 18 to 30 (BMI calculation: kg/m2)

   * Males weighing 50kg or more
   * Females weighing 45kg or more
3. No congenital or chronic diseases or pathological symptoms
4. A person who is judged to be suitable for the study by the investigator based on the clinical laboratory examination
5. A person who has fully understood the contents of the consent form for the study and signed the consent form voluntarily and recorded the date of signature
6. A person who agreed to use contraception from the first administration of IP to a week after the last administration of IP

Exclusion Criteria:

1. A person who has taken a drug that significantly induces (e.g., barbital) or inhibits the drug metabolic enzyme within 30 days prior to the first administration of IP
2. A person who has participated in other clinical trials within six months prior to the first administration of the IP
3. A person who has had whole blood transfusion within 2 months or the apheresis within 2 weeks before the first administration of IP
4. A person who has medical history of gastric resection that can affect the drug absorption
5. A person with a history of regular alcohol intake within a month prior to the first administration of the IP:

   * Male: More than 21 cups/week
   * Female: More than 14 cups/week (1 cup: 50 ml of soju, 250 ml of beer, 30ml of spirits)
6. A person who is hypersensitive to any of the IP components, taking glecaprevir, pibrentasvir, has active hepatic disease, Blood AST (GOT) or ALT (GPT) levels exceed the upper reference range limit by 3 times, muscle disease, or any genetic symtoms such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
7. A person who has medical history of mental disease
8. A person who is judged not to be suitable for the study by the investigator
9. Lactating or possibly pregnant women
Evaluation of PD 0348292 for Preventing Blood Clots in the Lungs or Deep Leg Veins of Patients After Knee Surgery

To study the safety and effectiveness of several doses of PD 0348292 compared to enoxaparin in preventing blood clots in the lungs or deep leg veins of patients after knee surgery


Eligibility Criteria:
Inclusion Criteria:

* Adult men or women scheduled for an elective, unilateral total knee replacement who are otherwise healthy.

Exclusion Criteria:

* History of deep vein thrombosis or pulmonary embolism, suspected postthrombotic state, bleeding or clotting disorders, or cardiovascular, renal or liver disease within the past year
Comparison of Two Types of Biopsy Forceps for Obtaining Cold Biopsy Polypectomy for Small Sessile Colorectal Polyps Less Than 6 mm in Diameter

The purpose of this study is to evaluate the efficacy of the new RJ4 compare with the standard RJ3 biopsy forceps for performing polypectomy for small colorectal polyps.


Eligibility Criteria:
Inclusion Criteria:

* colon polyps less than 6 mm

Exclusion Criteria:

* no colon polyps
The Effects of Dual Task Training with Different Task Priorities on Physical Performance and Cognitive Status in Patients with Parkinson's Disease

This study was planned to investigate and compare the effects of variable and fixed priority dual task training on balance, walking skills, mobility and cognition in patients with Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

* Having agreed to participate in the research after being given detailed information about the research.
* Having been diagnosed with Parkinson's disease by a specialist neurologist according to the UK Brain Bank criteria
* Being in stage 1-3 according to Hoehn \& Yahr
* Being 40 years of age or older

Exclusion Criteria:

* Having a neurological condition other than Parkinson's disease
* Cognitive impairment
* Have undergone deep brain stimulation surgery
* Having a visual, auditory or perceptual problem
* Having any orthopedic, rheumatological or other disease that may affect walking and balance.
Stroke Patients' Preferences for an Exoskeleton for Lower Limb Rehabilitation Using the DCE Method (EXOPREF)

The main aim of this study is to investigate the preferences of individual stroke patients for key features of an exoskeleton, intended for lower limb rehabilitation, with a view to its potential integration into the design of future exoskeletons. This will be a multicenter study. Patients will be presented different scenarios of choices about the attributes about gait exoskeleton.

Conditional logistic regression models will be used to define the preferences of the subjects.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* informed consent to participate in the study
* motor impairment secondary to stroke
* ability to answer the questionnaire with or without assistance from a relative or interviewer

Exclusion Criteria:

- history of lower-limb exoskeleton use
Mindfulness Based Intervention on the COVID-19 Related Distress and Mobile Addiction

The interventional study would be conducted to investigate the efficacy of mindfulness based intervention in order to treat psychological stress(anxiety, depression, and stress related COVID-19), and mobile phone addiction during COVID-19 pandemic.

In the current study the data was collected from the young adults (age range 19-35 years). The high scorer from the sample selected from the participants in both control and experimental groups. furthermore, the mindfulness based stress reduction intervention was given to the experimental group. The mindfulness based stress reduction intervention comprised eight weeks period. After the provision of intervention the data for the second phase would be collected.

Eligibility Criteria:
Inclusion Criteria:

* The participants fulfil the age criteria, students from public and private universities, and provided signed informed consent.

Exclusion Criteria:

* Participant suffering from chronic physical or psychological disorder. In addition participant who experience death of loved ones during COVID-19 pandemic.
Medtronic RevElution Trial

The purpose of this trial is to evaluate the clinical safety and efficacy of the Polymer-Free Drug-Eluting coronary stent system for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) that allows use of stents between 2.25 and 3.50 mm in diameter.


Eligibility Criteria:
Inclusion Criteria:

* Must be an acceptable candidate for percutaneous coronary intervention, stenting, \& emergent coronary artery bypass graft (CABG) surgery
* Must have evidence of ischemic heart disease
* Must require treatment of either a) a single target lesion amenable to treatment with a 2.25 mm - 3.50 mm stent OR b) two target lesions located in separate target vessels, with at least one of the target lesions amenable to treatment with a 2.25 mm - 3.50 mm mm study stent
* Target lesion(s) must be de novo lesion(s) in native coronary artery(ies)

Exclusion Criteria:

* Known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, thienopyridines, cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated
* History of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
* History of a stroke or transient ischemic attack (TIA) within the prior 6 months
* Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months
* History of bleeding diathesis or coagulopathy or will refuse blood transfusions
* Concurrent medical condition with a life expectancy of less than 5 years
* Currently participating in an investigational drug or another device trial that has not completed the primary endpoint
* Documented left ventricular ejection fraction (LVEF) \< 30% at the most recent evaluation
Efficacy of Sodium Heparin for Prophylaxis of Venous Thromboembolism in Surgical Patients

The aim of this study is to verify, through clinical examination and doppler, the non-inferiority of the drug test (heparin sodium 5.000UI/0.25 mL - HIPOLABOR) in relation to the drug compared (heparin sodium 5.000USP/mL - APP) in preventing the development of venous thromboembolism (VTE) in patients undergoing surgery for medium risk for the development of this pathology.


Eligibility Criteria:
Inclusion Criteria:

* Accept all items described in IC signing it in two ways;
* Be aged between 18 and 60;
* Be alert to the need for surgery antithrombotic prophylaxis;
* Be classified as "moderate risk" for developing VTE, according to the protocol of prophylaxis of deep vein thrombosis of the Brazilian Society of Angiology and Vascular Surgery.

Exclusion Criteria:

* Acute coronary syndrome, it will make use of anticoagulation;
* Immobilization of the lower limbs due to fractures, because in this way will be considered as high risk;
* History of recent stroke;
* Patients at high risk of bleeding in which the use of heparin is contra-indicated;
* General Surgery in patients over 60 years in the case of patients at high risk for VTE;
* general surgery in patients 40 to 60 years with additional risk factors for development of VTE;
* Major amputations;
* More orthopedic surgeries;
* Patients with pre-surgical diagnosis of malignant neoplasms;
* Patients with a platelet level below 100x109 / L;
* Use of anticoagulants 48 hours before randomization;
* Severe liver failure;
* Be classified as "Low Risk" or "high risk" for developing VTE, according to Maffei et al. (2005);
* Pregnancy and lactation.