cyrilzakka/clinical-trials huggingface dataset:
Virtual Reality in Rehabilitation of Executive Functions in Children With Attention Deficit Hyperactivity Disorder.

Attention deficit hyperactivity disorder (ADHD) is caused by an abnormality in the development of the central nervous system. Children with attention and executive function difficulties often need long-lasting rehabilitation and there is an increasing need for timely, cost-effective, and feasible rehabilitation interventions, where the training is targeted to support everyday life functional capacity. The use of Virtual Reality (VR) in the rehabilitation of children with attention and executive function deficits offers opportunities to practice skills required in everyday life in environments emulating real-life situations.

The major aim of this research project is to develop a novel effective VR rehabilitation method for children with deficits in attention, activity control and executive functions by using the virtual environment that corresponds to the typical everyday life. In this randomized control study VR glasses are used to present the tasks, and the levels of difficulty are adjusted according to the child's progress.

Researchers expect that; 1) Intensive training improves the attention regulation, activity control skills and executive functions of the children in the intervention group; 2) Training of executive skills with motivating tasks in a virtual environment that is built to meet challenging everyday situations transfers to the child's everyday life, 3) The duration of the training effect does not depend on the success of the VR training itself, but on how well the child adopts new strategies that make everyday life easier and how the parent is able to support the child's positive behaviour in everyday life.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ADHD (ICD-10 F90.0) and
* Methylphenidate medication and
* Age 8-12 years and
* Finnish as a native language

Exclusion Criteria:

* Sensitivity to flashing light,
* Epilepsy (ICD-10 G40),
* Mental retardation (ICD-10 F70-F79),
* Pervasive developmental disorders (ICD-10 F84),
* Inflammatory diseases of the central nervous system (ICD-10 G00-G09),
* Severe cerebral palsy syndrome (ICD-10 G80, GMFCS 4-5, MACS 3-5),
* Traumatic brain injury ((ICD-10 S06),
* Brain tumour, and
* Multiple pregnancy
Effect of Pentoxifylline on Tight Junctions (TJs) of Intestinal Mucosa in Patients With Irritable Bowel Syndrome(IBS)

The purpose of this study is to determine the therapeutics effectiveness of oral pentoxifylline treatment in patients with IBS.

Disruption of the intestinal epithelial barrier is part of the pathophysiology of IBS favoring immune activation present in the mucosa of these patients and the development of symptoms in IBS. To evaluate the effect of treatment with pentoxifylline (PTX) in patients with IBS related to clinical response and modulation of the components of the epithelial barrier at the level of intestinal mucosa.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years old
* Most of the patient with IBS will be chose between the patients who go to Digestive System ambulatory external medical office from our Center.
* Be studied and with clinical monitoring al least 6 months before be included.
* Fulfill with Roma III Criteria for IBS (Gastroenterology 2006;130:1377-90) with moderate-severe seriousness according to Modification Francis Scale

Exclusion Criteria:

* 2 weeks before colon biopsia, any patient cann´t take salicylates, NSAID, antibiotics,anticholinergics,opiates or any other medication / product for asintomatic treatment of diarrea.
* 3 months before colon biopsia, any patient cann´t take medicaments as corticoides, antihistamines or immunosuppressive
* 6 months before colon biopsia, any patient cann´t recive radiotherapy or chemotherapy.
* Pentoxifilina Alergic Reactions
* Pregnants
* Grave kidney failure
* Grave Hepatic failure
* Menthal or legal disability to sign the consent
Study for Comparing The Pharmacokinetics of A Pregabalin Controlled Release Tablet 300mg With Immediate Release Formulation and to Assess the Effect of High Fat Diet in Healthy Male Subjects

The purpose of this study is to:

1. Compare the pharmacokinetics profiles of pregabalin sustained release tablet (300mg) to immediate release capsule(150mg \* 2).
2. Evaluate the effectiveness of food to pharmacokinetics profile of Pregabalin sustained release tablet.


Eligibility Criteria:
Inclusion Criteria:

* 19\~44 aged healthy adult.
* someone tho has at least 50kg body weight and ideal body weight ±20%

Exclusion Criteria:

* someone has acute symptom at screening phase
* someone has any disease or symptoms which is clinically significant
* someone had been determined during healthy examination in screening period
* AST or ALT \> 1.25 times than normal
* Total bilirubin \> 1.5 times than normal
* someone who has a history of allergy, anaphylaxis, drug abuse or misuse.
* someone who had enrolled to other clinical trial within the last 60 days.
* someone who had donated blood within the last 60 days.
* someone who can't take a meal derived from this trial.
* someone who has taken abnormal meals like which can affect to drug ADME
* someone who has taken other ETC drugs or oriental drugs within the last 14 days, Or OTC drugs within the last 7 days
* someone who has taken caffein continuously (coffee or green tea more than 5 cups per a day) or took caffein since 24hours before.
* someone who has taken alcohol more than 30g/day or smoked more than 10 piece of tobacco/day.
* someone who has galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Study of Addition of Panitumumab to Chemoradiation Therapy in Patients With Locally Advanced Head and Neck Cancer

The addition of chemotherapy to radiotherapy (chemoradiation) has improved outcomes for patients with locally advanced squamous cell carcinoma of the head and neck but additional improvements to treatment regimens are needed. The study is investigating if the addition of a targeted therapy (panitumumab) can improve the efficacy of chemoradiation without adding unmanageable toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Stage III or IVa-b (M0) squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (you must be well enough to receive chemoradiation therapy)
* You must be at least 18 years of age
* Your test results must show that your kidneys, liver and blood cells are working adequately and that, if you are female, you are not pregnant
* You must have measurable disease

Exclusion Criteria:

* Cancer of the nasopharynx, sinus, salivary gland or skin
* History of another cancer (other than head and neck) unless treated with curative intent and with no evidence of disease for more than 3 years, with the exception of non-melanoma skin cancer or in situ cervical cancer
* Previous treatment with anti-endothelial growth factor receptor (EGFr) antibody therapy or EGFr inhibitors
* Previous treatment for head and neck cancer, with chemotherapy, surgery (except nodal sampling or biopsy) or radiotherapy
* Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within one year before you join the study
* Chronic obstructive pulmonary disease (pneumonia or respiratory decompensation) resulting in hospitalization within 6 months of study screening
* History or evidence of interstitial lung disease (e.g. pneumonitis or pulmonary fibrosis)
* Major surgery within 28 days of screening
Monocentric Phase 1 Study With Escalation of Doses of Tocilizumab in Combination With Chemotherapy (Idarubicin and Cytarabine) in Patients With Acute Myeloblastic Leukemia (AML)

This is a phase 1 dose escalation study testing the addition of an anti-IL6 (tocilizumab) to standard induction chemotherapy for high-risk AML.

Administration of tocilizumab at day 8 of induction following a classical induction using idarubicin 8mg/m2/d for 5 days and cytarabine 100mg/m2/d for 7 days.

Eligibility Criteria:
Inclusion Criteria:

- AML with a poor prognosis defined according to the criteria below: LAM First line: Age \<60 years and unfavorable risk according to the 2017 ELN Age\> = 60 years old and intermediate or unfavorable risk according to the ELN 2017 LAM in Relapse: whatever the age

* ECOG \<= 2
* Patient eligible for intensive chemotherapy
* Informed consent
* Liver function tests: transaminases \<3x normal, bilirubin \<1.5X normal
* Creatinine clearance\> 60ml / min
* LVEF\> = 50%

Exclusion Criteria:

* Uncontrolled infection
* Hep B, C, HIV +
* History of diverticulosis / diverticulitis
* No social security or any other scheme
* Pregnant women or patient unable to take contraception(contraceptive pill, abstinence, IUD unauthorized) in case of fertility. A patient who cannot continue contraception for at least 3 months after the last injection of TOCILIZUMAB is not eligible.
* Lactating women
* Minors
* Adults under guardianship, curatorship or legal protection
* Hypersensitivity to one of the active substances or to one of the excipients
* Patients with tuberculosis
* Patients documented with active COVID
Sleep, Diabetic Retinopathy and Melatonin

This study explores the use of melatonin in patients with diabetic retinopathy

This is a randomized controlled study using melatonin for 8 weeks in patients with diabetic retinopathy on outcomes of sleep and circadian regulation

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes (clinically diagnosed, taking anti-diabetes medications or history of elevated A1C≥6.5%)
* 40-65 years of age
* Diabetic retinopathy of at least moderate degree

Exclusion Criteria:

* use of melatonin
* antidepressants or antipsychotics
* illicit drug use
* night shift work or travel beyond 2 time zones in the month before enrollment
* end stage renal disease requiring renal replacement therapy
* history of stroke or transient ischemic attacks
* history of dementia or memory impairment
* uncontrolled congestive heart failure or recent hospitalization for cardiac condition (6 months)
* chronic obstructive pulmonary disease requiring oxygen
* severe chronic liver disease such as cirrhosis
* ongoing treatment for major medical problems such as cancer
* history of severe hypoglycemia defined as hypoglycemic episodes requiring assistance from others within the past six months.
* Significant depressive symptoms
* untreated severe OSA (AHI≥ 30 events/hour),
* uncontrolled hypertension (blood pressure ≥ 160/100 mmHg),
* uncontrolled diabetes (A1C ≥ 11%),
* abnormal TSH
* abnormal liver function (AST or ALT\>3x upper limits of normal
* use of sedatives and hypnotics.
* clinically significant epiretinal membranes, clinically significant lens opacities, or cystoid macular edema, iris neovascularization, iris atrophy, or an asymmetrically shaped pupil, nuclear sclerotic, posterior subcapsular, or cortical lens opacities greater than 2+, a history of pan-retinal photocoagulation.
* hemoglobin \<11.5 g/dL in women and \<13.5 g/dL in men.
Efficacy of Shitali Respiratory Rehabilitation Program in Obstructive Sleep Apnea

obstructive sleep apnea has a negative impact on blood pressure of patients, sleeping quality, and respiration

in this study, patients (n=40) with obstructive sleep apnea will participate in this study to be divided in to group I and group II with an equal number of patients (n = 20 for the group). Group I will administer six cycles of 5-min shitali respiratory pranayama exercise rehabilitation training (the rehabilitation will be repeated or applied at morning, afternoon, and also at evening) for 12 week as a daily performance, the other group, Group II, will act as control group.

Eligibility Criteria:
Inclusion Criteria:

* non-obese patients
* obstructive sleep apnea (mild and moderate form)

Exclusion Criteria:

* cardiac patients metabolic diseases kidney diseases
Does a Brief Intervention Decrease Patient Drop Out Rates?

The goal of this study is to determine a) if a follow-up email to selected patients who had an initial consult with an infertility specialist, but did not return for a second visit, would change return to care behavior and b) why patients had not returned.

From July 2017 to March 2018 all patients who had attended an initial visit with an infertility specialist at the clinic, but had not returned for at least three months were selected to receive a follow up email. Those selected for an email excluded patients who the Investigator's knew had achieved a pregnancy, already had a plan for treatment, had visited for an egg freeze and all LGTBQ patients. The email asked if the patient had any questions about that visit, offered support to the patient and included contact information for the patient liaison sending the email. The email also asked each participant to indicate why they had not returned and were provided 4 options and an opportunity to write in a response. From April 2018 to December 2018 no emails were sent to patients. No other change of patient contact practice was initiated during the trial period. This study will observe routine to care behavior of these patients after 11 months post initial consult date.

Eligibility Criteria:
Inclusion Criteria:

* Female patients attending an initial consult with a physician at Boston IVF and were recommended to continue care with the clinic

Exclusion Criteria:

* Patients who the Investigators knew had achieved a pregnancy
* Patients who already had a plan for treatment in place after their initial consult
* Patients who had visited for an egg freeze
* LGTBQ patients
A Study to Evaluate the Use of Mobile-phone Based Patient Support in Patients Diagnosed With Myocardial Infarction

The purpose of this study is to evaluate whether the mobile-phone based patient support has an impact on the adherence and persistence of ticagrelor treatment or on lifestyle changes that will have a positive impact on the cardiovascular risk factors.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of written patient informed consent.
2. Patients must have a smart phone at their disposal and use it on a daily basis.
3. Female or male aged \>18 years, diagnosed with a ST elevation Myocardial Infarction (STEMI) or non ST elevation Myocardial Infarction (NSTEMI) and treated with ticagrelor prior to inclusion into this study and for which the treating physician intend to continue prescribing ticagrelor according to the prescription recommendation.
4. Ability to read, understand and write Swedish.

Exclusion Criteria:

1. Participation in any clinical trial or device study in the last 30 days excluding prospective/retrospective register based studies that do not require any extra visits in addition to ordinary health care.
2. Patients not suitable for participation based on the investigators judgment for example:

   * Patients on treatment with triple antithrombotic treatment.
   * Patients on treatment with anticoagulantia.
   * Patients accepted/with a plan for thoracic surgery (CABG) or any other elective surgery that cannot be postponed until after study participation.
   * Patients with a life expectancy of less than 12 months.
   * Patients judged to be unable to follow a structured physical activity program.
3. Patients those are pregnant or lactating.
4. Patients involved in the planning and/or conduct of the study (applies to AstraZeneca staff and/or staff at the study site and application developer).
Local Administration of Tranexamic Acid in Upper Gastrointestinal Hemorrhage

Upper gastrointestinal hemorrhage is a frequently diagnosis in emergency departments. Although new drugs and endoscopic techniques were easily applied in various settings in this condition, the role of local administered therapies such as antifibrinolytic agents remain unclear. The investigators aimed to compare standard therapy (proton pump inhibitors, endoscopic treatments etc.) and standard therapy + local administered tranexamic acid in upper gastrointestinal hemorrhage in a double-blind, randomized trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with upper gastrointestinal hemorrhage to the ED
* Patients older than 18 years
* Patients who agree to participate the study by reading and signing the informed consent form

Exclusion Criteria:

* Patients younger than 18 years
* Patients who do not agree to participate the study
* Documented or declared allergy to tranexamic acid
* Upper gastrointestinal hemorrhage secondary to trauma
* Upper gastrointestinal hemorrhage secondary to esophageal varices
* Patients who cannot undergo to endoscopy for any reason
* History for thromboembolic disease
* Patients with renal impairment
Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of 5.6 mg TNX-102 SL (2 x 2.8 mg tablets)-a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible patients will have a telephonic visit at week 2 and then return regularly to the study clinic for monthly visits for assessments of efficacy and safety.


Eligibility Criteria:
Inclusion Criteria:

* Male or female between 18 and 75 years of age, who have served in any branch of the military.
* Diagnosed with current PTSD as determined by the Clinician-Administered PTSD Scale (CAPS-5) for DSM-5.
* Index trauma(s) resulting in PTSD must meet DSM-5 criterion A for PTSD as described in CAPS-5, have occurred in 2001 or later, be military service related.
* Willing to refrain from use of all other formulations of cyclobenzaprine.
* Willing and able to refrain from antidepressants and other excluded medications.
* Capable of reading and understanding English and able to provide written informed consent.
* If female, either not of childbearing potential or practicing a medically acceptable method of birth control throughout the study.
* Willing and able to comply with all protocol-specified requirements.

Exclusion Criteria:

* Increased risk of suicide, based on the investigator's judgment that is of a severity that is not appropriate for outpatient management, or that warrants additional therapy excluded by the protocol.
* Significant (e.g., moderate or severe) comorbid traumatic brain injury (TBI) by history.
* Severe depressive symptoms at screening or baseline.
* Clinically significant laboratory abnormalities based on screening laboratory tests and/or medical history in the investigator's opinion.
* Use of antidepressant medication within 2 months of baseline.
* Female patients who are pregnant or lactating.
* History of serotonin syndrome, severe allergic reaction or bronchospasm or known hypersensitivity to cyclobenzaprine or the excipients.
* Seizure disorder.
* Patients with a body mass index (BMI) \> 45.
* Has received any other investigational drug within 30 days before Screening.
* Previous participation in any other study with TNX-102 SL.
* Family member of investigative staff.
Evaluating the Incidence of Pseudo-Acute Kidney Injuries in Patients With Metastatic Breast Cancer on CDK4/6 Inhibitors Trough Cystatin C Analysis

CDK4/6 inhibitors have led to an improvement of both progression free survival (PFS) and overall survival (OS) in patients with advanced estrogen positive (ER+)/HER2- breast cancer when applied in the first or second line of treatment. Despite the advantages of CDK4/6 inhibitors, these medications can lead to adverse effects. One of the adverse events observed across all types of CDK4/6 inhibitors is an elevation in creatinine levels. An elevation in plasma creatinine during treatment with abemaciclib is not always indicative of a reduction in renal function; it can also be attributed to the inhibition of active tubular secretion of creatinine. This phenomenon is known as pseudo acute kidney injury (pseudo-AKI).

The incidence of pseudo-AKI in patients using CDK4/6 inhibitors is currently unknown. A method to distinguish pseudo-AKI from AKI is measuring the level of an alternative filtration marker in blood, for example cystatin C. Cystatin C is also filtered at the glomerulus but not secreted intro the renal tubulus or reabsorbed into the bloodstream. Also, there is no affection by muscle mass or diet. In this study the investigators will explore the incidence of both AKI and pseudo-AKI in patients who are treated with CDK4/6 inhibitor treatment by assessing both creatinine and cystatin C in plasma.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients who are receiving CDK4/6 inhibitors for metastatic breast cancer
* Patients must have used the CDK4/6 inhibitor for a minimum duration of one month
* Patients must have undergone at least one measurement of creatinine after the initiation of CDK4/6 inhibitor treatment

Exclusion Criteria:

- Patients who are undergoing dialysis therapy for kidney failure.
Evaluation of Lidocaine Spray Versus Dexmetomidine Spray on Stress Response

Many studies discussed attenuating stress response by various measures but to the interest of our study , No one compared topical spray of both lidocaine and dexmedetomidine in attenuating the haemodynamic stress responses of laryngoscopy and endotracheal intubation, avoiding undesired systemic effects of drugs ,

This study will be conducted in the operating theatres of Cairo university hospitals.

Patients undergoing any surgery under general anesthesia and needs endotracheal intubation using direct laryngoscopy will be assigned to one of the three groups:

Group C: will receive 5ml of normal saline sprayed via long nostril syringe into oropharynx, the vocal cords and tracheobronchial tree 5 minutes before intubation Group L: : will receive 5ml of lidocaine 2% (100mg) sprayed via long nostril syringe into oropharynx , the vocal cords and tracheobronchial tree 5 minutes before intubation Group D: : will receive dexmedetomidine (1 μg/kg) diluted in 5ml normal saline sprayed via long nostril syringe into oropharynx , the vocal cords and tracheobronchial tree 5 minutes before intubation.

Eligibility Criteria:
Inclusion Criteria:

* • ASA I,II

  * Age 18-60y
  * Patients scheduled for any operations under general anesthesia and needs endotracheal intubation using direct laryngoscopy in the operating theatre.

Exclusion Criteria:

* • Uncontrolled high blood pressure \> 160/100 heart disease in the form of ischemic heart disease and severe valvular disease.

  * Patients with the history of allergy to lidocaine or dexmedetomidine.
  * ASA III \& IV.
  * Patients refuse to share in this study
  * Suspected difficult intubation that needs more than 2 trials.