cyrilzakka/clinical-trials huggingface dataset:
Touch Screen Usage Time In Relation To Visual Motor Integration and Quality of Life In Preschoolers

Recent literatures are associating digital technology extensive and addictive use with physical, psychosocial and cognitive inverse consequences. This research focuses more on number of touch screen devices; age started using devices and usage time in relation to cognitive function in preschoolers.

A hundred typically developing preschool children of both genders with age ranges from three to five years will be included in this study. Visual motor integration, quality of life and cognitive function were assessed by the Peabody Developmental Motor Scale, the Pediatric Quality of Life Inventory™ and the Pediatric Quality of Life Inventory™ cognitive functioning scale respectively

Sample size To avoid type II error, sample size calculation was based on data from a pilot study on correlation between touch screen usage time and visual motor integration. Using G\*POWER statistica software (version 3.1.9.2; Franz Faul, Universitat Kiel, Germany) \[Correlational study, α=0.05, β=0.2, and medium effect size = 0.3\] revealed that the appropriate sample size for this study was N=84 Therefore, one-hundred children were recruited for possible dropouts during assessment.

Eligibility Criteria:
Inclusion criteria:

Children were enrolled in this study according to the following criteria:

* Age ranges from three to five years.
* Both genders were included.

Exclusion criteria:

Children were excluded from the study if they had any of the following criteria:

* Diagnosed with attention deficit/hyperactivity disorder (ADD/ADHD) or developmental co-ordination disorder (DCD).
* Preterm children; children with major physical disabilities, genetic disorders; prenatal exposure to alcohol; children with a history of head trauma and infections.
* Diagnosed with psychiatric conditions such as autism and depression.
* Diagnosed with significant behavioral disorders
* Diagnosed with fine motor problems.
* Significant auditory or visual deficits.
The Impact Of Platelet Function on 1-year Outcome in Complex PCI Patients

To identify the optimal cut-off values in different platelet function testing to predict MACCE at 12-months in complex PCI patients of China

This study will observe the relationship between platelet function testing and clinical outcomes. Meanwhile we aim to identify optimal cut-off values in different platelet function testing, including IPF, TEG and VerifyNow, to predict MACCE during12-months in complex PCI patients.

Eligibility Criteria:
Inclusion Criteria:

* Documented undergoing complex PCI in 1 year prior to enrollment.

Exclusion Criteria:

* Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language where interpreter services are not reliably available, psychiatric disturbances, alcohol or drug abuse).
* Presence of serious/severe co-morbidities in the opinion of the investigator which may limit life expectancy (\<1 year).
* Current participation in a blinded randomized clinical trial.
Hyperbaric Oxygen Therapy in Chronic Traumatic Brain Injury or Post-Traumatic Stress Disorder

This is an observational research study whose purposes are to see:

1. if 40 Hyperbaric Oxygen Therapy sessions at 1.5 atmospheres (HBOT 1.5) or more (60, or 80 HBOT's) help, worsen, or have no effect on subjects with chronic TBI/PCS (Traumatic Brain Injury/Post-Concussion Syndrome) and/or PTSD (Post-Traumatic Stress Disorder).
2. if improvements or worsening of symptoms can be recorded with computerized and written tests for memory and thinking, and with questionnaires about the subject's quality of life and health.
3. determine the long-term outcome of the treatment.
4. confirm, in large numbers of study participants at multiple sites nationwide, the strong positive results obtained in pilot studies


Eligibility Criteria:
Inclusion Criteria:

1. Any 18-65 year-old patient with mild-moderate TBI or PTSD. (If a military injury, subject may be active duty or a veteran. If active duty, participants will have to voluntarily contact NBIRR.)
2. Have demonstrated a \>20% decrement (compared to pre-deployment baseline) in ANAM composite score or specific sub-score with regard to "simple reaction time" and/or "procedural reaction time".
3. Have a diagnosis of TBI, chronic TBI/PCS or TBI/PCS/PTSD or PTSD made by a military (military etiology of blast injury) or civilian specialist.
4. Negative pregnancy test in females.
5. Less than 90% on the Percent Back to Normal Rating Scale. (If patient is considered 100% normal before TBI, patient should be less than 90% normal for entry into the study).

Exclusion Criteria:

1. Pulmonary disease that precludes HBOT (e.g., asthma unresponsive to medication, bullous emphysema).
2. Unstable medical conditions that are contraindicated in HBOT (e.g. severe congestive heart failure or heart failure requiring hospital emergency evaluation or admission in the previous year).
3. Severe confinement anxiety (claustrophobia; e.g., patients who require anesthesia conscious sedation for MRI or who cannot go in elevators).
4. Pregnancy.
5. Other pre-TBI neurological diagnoses.(seizure disorders, multiple sclerosis, Parkinson's, Lyme, etc.)
6. Participation in another experimental trial with active intervention.
7. High probability of inability to complete the experimental protocol (e.g. terminal condition).
8. Past or current history of mental retardation unless diagnosed post TBI (baseline IQ ≤ 70).
9. Pre- or post-TBI history of systemic illness with impact on central nervous system. (Principal Investigator in consultation with study sponsor Medical Officer will make the ultimate decision).
10. Any pre-existing chronic infection not related to battlefield injuries or government service.
Electromyographic Control of the Response in the Application of Vojta Therapy in People With Brain Injury.

A non-randomized clinical trial on a cohort of healthy subjects of legal age, both sexes, recruited from the university community and who will be randomly distributed into two groups (experimental and control). The objective will be to determine the feasibility of the standardized intervention protocol on the stabilizing muscles of the trunk (external oblique and internal oblique) before, during and after the application of Vojta Therapy, and to know the effects produced on the Musculature studied after performing the intervention.


Eligibility Criteria:
Brain injury group

Inclusion Criteria :

* Over 18 and under 80 years of age
* Persons with a medical diagnosis of brain damage secondary to stroke
* Have preserved the ability to walk, even with some type of orthopedic some type of orthopedic aid,

Exclusion Criteria:

* Over 80 years
* Healthy people

Group without brain damage

Inclusion Criteria :

* Over 18 and under 80 years of age
* Healthy people
* Full cognitive capacity.

Exclusion Criteria:

* Subjects with neuro-muscular pathologies that affect the abdominal muscles, previous surgeries in the area or any chronic neurological or organic disorder that may alter the results.
* Fever
Prevalence and Associated Factors of Functional Gastrointestinal Disorders Among Children

The definition of Functional Gastrointestinal Disorders (FGIDs) has changed over time from the absence of organic disease to a stress-related or psychiatric disorder to a motility disorder, and with Rome III, to a disorder of GI functioning, then Rome iv in 2016 defined FGIDs as : disorders of gut-brain interaction. It is a group of disorders classified by GI symptoms related to any combination of the following: motility disturbance, visceral hypersensitivity,altered mucosal and immune function, altered gut microbiota, and altered central nervous system (CNS) processing. FGIDs are observed in infants and young children worldwide with variable frequency related studies done in variable places around the worled show the following results : the prevalence of FGIDs in Chinese infants and young children is 27.3%.and 40 % in south american infants and 30 % of african infants and 35.1 % of infants presented to tertiary care hospital in Istunbul.Turkey.

The etiology of these disorders remains uncertain and thought to be due to subtle alteration of the normal development or maladaptive behavioral response to a variety of internal or external stimuli .As a group of disorders; FGIDs in young children are a major challenge to the already overstretched pediatric gastroenterology services across the world .Infants and young children with FGIDs visit medical professionals more frequently and experience poor quality of life . In addition, FGIDs in infancy are linked with detrimental repercussions such as maternal depression, poor infant and mother bonding,and poor physical growth .

Eligibility Criteria:
Inclusion Criteria:

* Age group 1 to 18 years old

Exclusion Criteria:

* Age group bwlow 1 year and above 18 years

Having other git problem as :

* GIT bleeding
* H pylori infection
* Cow's milk protein allergy or IBD or any other symptoms suggestive to organic GI disease
Long Term Outcomes of Venous Thromboembolism

This prospective observational follow-up study is designed to assess the long-term outcomes after Venous thromboembolism (VTE) and to assess the effect of the new oral anticoagulant (NOAC) rivaroxaban on the prevalence of post-thrombotic syndrome (PTS).

The study will not be testing any formal hypothesis.

This prospective observational follow-up study is designed to assess the long-term outcomes after VTE and to assess the effect of NOAC (rivaroxaban) on the prevalence of PTS. All patients diagnosed and treated for VTE at SØF from 01.01.2011 will be invited to participate in this study. Newly diagnosed patients will be recruited and followed-up according to the study schedule which is based on state of the art international guidelines.

First follow-up will be performed at the end of treatment period, which is usually 3 or 6 months after an event of VTE, or at one year if patients will be put on permanent AC. Thereafter, patients will be followed-up annually for at least 5 years or up to the end of the study, i.e for 10 years.

The primary endpoints of the study are the development of PTS and CTEPH after VTE. There will be 3 visits: at 3 or 6 months depending on the duration of AC, at 2 and 5 years, in addition to a visit for TTE at 6 months. Remaining follow-ups will be performed by phone or by mail. All patients with PE will be examined by TTE 6 months after the diagnosis of PE. Those with signs of PAH will be referred for further work-up to establish the presence or absence of CTEPH at specialized centres. Patients with DVT will be evaluated for PTS at 2 and 5 years and for CTEPH if they develop dyspnoea. As for part b of the primary objective, the study will allow inclusion of patients with previous DVT diagnosed after 01.01.11.

Eligibility Criteria:
Inclusion Criteria:

* Patients with objectively verified first time DVT diagnosed after 01.01.11 for study A, OR objectively verified DVT and/or PE dignosed after 01.04.14 for study B.

  * 18 years of age
* Signed informed written consent

Exclusion Criteria:

* Patients who refuse to consent
* Patients who have been treated with other anticoagulants than thoose included in the study
* Patients who can not participate due to logistic reasons
Sling vs No Sling After Reverse Total Shoulder Arthroplasty

This study involves patients who will be undergoing a reverse total shoulder replacement at Duke University. 100 eligible will be randomly assigned into one of two groups, a sling or no sling group. Patients in the sling group will wear a sling for three weeks after their surgery while the no sling group will only wear a sling three days after their surgery. Patients will follow their doctors normal follow up visit schedule after surgery, with visits at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years.

The purpose of this study is to determine whether or not a sling is necessary after the nerve block has worn off postoperatively for patients undergoing reverse total shoulder arthroplasty. Patients who are scheduled for a reverse total shoulder with the participating investigators will be approached for potential participation in the study.

Before the surgery, subjects will be randomly assigned to either the Sling (control) group or the No-Sling (investigational) group. The Sling, or control, group will wear a sling through 3 weeks postoperatively. The No Sling (investigational) group, will wear a sling either through 3 days postoperatively.

Following surgery, patients will be followed at their standard of care visits at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years after their surgical date. The investigators will collect data from these standard of care visits including PROs (including but not limited to ASES and SANE), Adverse events data, and physical exam data including range of motion. Patients will be followed through their two-year visit and then taken off study.

Eligibility Criteria:
Inclusion Criteria:

* Patient is scheduled to undergo a primary reverse shoulder arthroplasty procedure
* Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy
* Patient meets indications for primary reverse shoulder arthroplasty for the following diagnosis
* Rotator cuff arthropathy
* Glenohumeral arthritis
* Patient is between 18-100 years old
* Patient is English speaking

Exclusion Criteria:

* A history of ipsilateral shoulder arthroplasty
* A history of shoulder septic arthritis
* A history of a proximal humeral fracture
* Chronic locked dislocation
* Rheumatoid arthritis
* Tumors
* Axillary nerve damage
* Non-functioning deltoid muscle
* Glenoid vault deficiency precluding baseplate fixation
* Infection and neuropathic joints
* Known or suspected non-compliance, drug or alcohol abuse
* Patients incapable of judgement or under tutelage
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for imaging etc.
* The subject is related to investigator as family members, employees, or other dependent persons
An Investigation on the Effect of Age and BMI on the Pharmacokinetics of Transdermal Granisetron

This study aims to evaluate the effect of age and BMI on the pharmacokinetics and safety of Sancuso®.

Sancuso® (granisetron transdermal system \[TDS\] or patch) was approved by the United States (US) Food and Drug Administration (FDA) in September 2008, indicated for the prevention of nausea and vomiting in patients receiving moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days' duration.

While in vivo pharmacokinetic studies with Sancuso® in healthy adults and in subjects receiving chemotherapy have been conducted, there are limited data from subjects who have altered skin integrity due to advanced age or poor nutritional status related to chronic illness. In addition, available data suggest that granisetron is delivered into subcutaneous fat and is released from that compartment over time. It is possible that individuals with varying nutritional status and resultant differences in subcutaneous fat would have differences in pharmacokinetics.

Eligibility Criteria:
Inclusion Criteria:

-- Healthy male or female subjects:

Part I

* Aged ≥ 65 years at screening
* Control group: aged ≥ 18 to 45 years at screening

Part II -- Aged between 18 and 60 years, inclusive, at screening

Part I

-- BMI between 20.0 and 29.9 kg/m², inclusive

Part II

* Underweight (BMI \< 18.5 kg/m²) or obese (BMI between 30.0 and 39.9 kg/m², inclusive)
* Control group: BMI between 20.0 and 24.9 kg/m², inclusive

Exclusion Criteria:

* Current or previous disease, disorder, allergy or condition that could affect study conduct or laboratory assessments, or that presents undue risk from study medication or procedures.
* Physical examination or screening investigation result that indicates subject is unfit for study.
* Scarring on upper arms.
* Positive virology, urine drugs of abuse or pregnancy test result (female subjects of childbearing potential only).
* Recent use of prescribed or over-the-counter medication.
* Received an investigational drug within 3 months (90 days) prior to patch application.
* Loss of ≥ 400 mL of blood (e.g. been a blood donor) within the previous 3 months.
* Average weekly alcohol consumption \> 21 units (males) or 14 units (females), or habitually smokes ≥ 5 cigarettes or equivalent tobacco per day within the 6 months before patch application.
* Lactating female subjects and female subjects of childbearing potential not willing to use an acceptable form of contraception during and for 90 days after the study.
* Employee of the investigator or study centre, with direct involvement in the proposed study or other studies under the direction of that investigator or study centre, as well as family members of the employees or the investigator.
Respiratory Function Monitoring of Mechanical Ventilation in Patients With Chest Blunt Injury

The goal of this observational study is to learn about EIT in observing the application of lung protective ventilation strategies in patients with pulmonary contusion, particularly the impact on pulmonary ventilation blood flow ratio, oxygen, and condition. The main question it aims to answer is:

Can lung protective ventilation strategies improve respiratory function in patients with severe chest contusion? We will collect clinical data of participants who already taking lung protective ventilation strategies as part of their regular medical care.

Trauma is the leading cause of death among middle-aged and young people in China, with over 25% of patients dying from chest trauma. The incidence of pulmonary contusion in severe chest trauma is over 70%, and it is an important cause of respiratory failure and even death in patients. The occurrence of pulmonary contusion and respiratory failure in patients with chest contusion is a dynamic process, and Regional inhomogeneities of the damaged lung should be taken into consideration to develop improved ventilation strategies. Currently, there is no ideal monitoring method to evaluate the severity of injury, and guide the ventilation strategies. Electrical impedance tomography (EIT) is a non-invasive, radiation-free imaging technique. It measures regional lung ventilation and aeration distribution by means of changes in electrical potentials at the skin surface of the chest wall during breathing cycles, which has been proven to have good practicality in patients with non-invasive ARDS and pulmonary embolism. In this study, we aim to characterize the physiologic effects of positive end expiratory pressure (PEEP) on key mechanisms of regional lung protection, namely: recruitment, reduced atelectrauma, and improved ventilation-perfusion matching, by CT scan and EIT

Eligibility Criteria:
Inclusion Criteria:

* Patients with severe chest contusion admitted to the intensive care unit (ICU);
* Abbreviated Injury Scale (AIS) ≥ 3 and/or Blunt Pulmonary Contusion 18 score (BPC18) ≥ 3;
* Age range from 18 to 90 years old;
* Mechanical ventilation;
* Stay in the ICU for less than 12 hours.

Exclusion Criteria:

* Perinatal women;
* Expected to be mechanically ventilated for less than 48 h;
* Expected duration of stay in the ICU is less than 24 hours;
* There are contraindications for the use of EIT (pacemaker implantation, local skin wounds after chest surgery, etc.);
* Accept extracorporeal membrane oxygenator;
* Mechanical ventilation\>7 days;
* Confirmed ventilator-associated pneumonia;
* Pneumothorax without drainage or presence of subcutaneous emphysema.
TMS in Treatment of Schizophrenia Negative Symptoms

Primary objective: to examine the efficacy and safety of high frequency repetitive transcranial magnetic stimulation (HF rTMS) with H7-coil applied once daily during the twenty days, augmentative to the standard antipsychotic pharmacotherapy and other treatment of negative symptoms in schizophrenia.

Targeted population: patients diagnosed with schizophrenia, 18-55 years old with predominant negative symptoms, stable condition for \>3 months and unchanged antipsychotic therapy for \>1 months and no treatment with antidepressants.

Study design: industry independent, multicenter, prospective randomized sham-controlled, two-arms, triple-blind superiority clinical trial with concealed allocation and masked independent outcome assessment.

Primary outcome: adjusted median of differences in total SANS score. Adjustment for age, gender, baseline total SANS score, duration of the disorder, and antipsychotic therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmation diagnosis of schizophrenia (ICD-10 F20) using the Mini-International Neuropsychiatric Interview (MINI) (Lecrubier et al., 1997; Sheehan et al., 1998),
2. Age 18-55 years,
3. Both genders,
4. PANSS negative symptoms subscale score \>24,
5. PANSS positive symptoms subscale score \<20,
6. Stable condition (no acute psychosis exacerbation, no psychiatric hospitalization because of relapse or worsening of symptoms) during at least three months,
7. Stable antipsychotic therapy with no change of drugs or doses during the one months before the enrollment.

Exclusion Criteria:

1. Antipsychotics dose change or change of antipsychotic drug,
2. Hospitalization for somatic illness in another institution,
3. Termination of treatment in a Psychiatric Hospital "Sveti Ivan",
4. Pregnancy,
5. Missed more than three consecutive interventions,
6. Withdrawal of consent to participate for the sake of intolerance of TMS or for other reasons.