cyrilzakka/clinical-trials huggingface dataset:
Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Lennox-Gastaut Syndrome

This Phase 3 trial will enroll participants diagnosed with Lennox-Gastaut Syndrome (LGS) who are still experiencing at least 4 motor seizures involving the trunk or extremities per week, despite ongoing treatment with up to 3 antiepileptic drugs (AEDs) and who meet inclusion/exclusion criteria.

Following a 28-day baseline period, participants will begin an 84-day treatment period. Participants will be assigned to receive twice daily doses of placebo or cannabidiol oral solution at the highest dose determined to be safe in a previous trial.

Following study completion, all participants will be invited to receive Cannabidiol Oral Solution in an open label extension study (under a separate protocol).


Eligibility Criteria:
Inclusion Criteria:

* Meets protocol-specified criteria for qualification and contraception, including clinical diagnosis of refractory LGS and onset of seizures according to protocol-specified criteria
* Is able to speak and understand the language in which the study is being conducted, is able to understand the procedures and study requirements and has voluntarily signed and dated an informed consent form approved by the Institutional Review Board before the conduct of any study procedure
* In the opinion of the Investigator, the participants and parent(s)/caregiver(s) are willing and able to comply with the study procedures and visit schedules, including venipuncture, twice daily dosing, accurate diaries, and the Follow-up Visits (if applicable).

Exclusion Criteria:

* Medical history is outside protocol-specified parameters
* Clinically significant history of allergic reactions or significant sensitivities to cannabinoids or to any of the other ingredients in the study drug
* Inadequate supervision by parents or guardians
* History or current use of dietary supplements, drugs or over-the counter medications outside protocol-specified parameters
* Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1) the safety or well-being of the participant or study staff; 2) the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); 3) the analysis of results
Post Extubation Dysphagia

The investigators hypothesize that aspiration will be more prevalent at two to four hours post-extubation but will resolve in the majority of patients by 24 to 26 hours post-extubation.

The purpose of the research is to investigate whether there is a difference in swallow function two to four hours after extubation (removal of breathing tube) compared to 24 hours after extubation. This information will help healthcare providers decide if it is necessary for people to wait 24 hours after extubation before they start eating and drinking.


Eligibility Criteria:
Inclusion Criteria:

* Patients that were intubated for more than 48 hours.
* Adults, 18 and over
* All races
* Males and females
* Approval to participate in the study by the treating physician

Exclusion Criteria:

* Patients with a history of oropharyngeal dysphagia.
* Patients with neurological disorders associated with dysphagia including dementia, Parkinson's disease, multiple sclerosis, stroke, and ALS.
* Patients with a history of head and neck cancer or laryngeal surgery.
* Patients that are not candidate for FEES because of facial fractures, nothing by mouth (NPO) status for other procedures, elevated bleeding risk (patients on therapeutically dosed anticoagulant infusion or injection, platelet count less than 50,000, INR greater than 2.0, partial thromboplastin time greater than 1.5 times normal), decreased level of arousal/alertness, significant agitation, or inability to tolerate room air or nasal cannula oxygen for duration of FEES.
* Patients who are extubated after 1400 or on weekends (Friday, Saturday, or Sunday).
* Non-English Speakers will be excluded
Cognitive Behavior Therapy for Social Media Addiction, Insomnia, and Family Relationship Among Individuals With Social Media Addiction: A Randomized Control Tria

Objectives This study is designed to investigate the following objectives To manage the social media addiction in order to improve lifestyle, attitude and family relations of the individuals and explore related psychological problems which can arise because of this addiction.

To explore the effectiveness of cognitive behaviour therapy (CBT) in the management of social media addiction in individuals which is decreasing the health of their lifestyle, attitude and family bonding.

To explain how abusive use of social media can increase the risk of psychological and behavioural problems.

A sample of 150 individuals (male and female N=150) was recruited from different universities of Faisalabad for the purpose. A strategy of non-probability sampling of purposive technique was used for the recruitment of sample. The age range for the sample will be 18-22 as young adults and adults was targeted. Firstly individuals were screened out through social media addiction scale from which (n=60) participants were excluded because they did not meet the inclusion criteria of the study. Some participants left because lack of interest. After excluding (n=60) from the study rest of the participants (n=90) were randomized and allocated to experimental (n=45) and control group (n=45). After allocation of participants in the relevant group some participants were lost from the follow up from experimental (n=21) due to decline to participate and control group (n=20) due to lack of interest. Final analysis was conducted on experimental group and (n=24) control group (n=25) for the study.

Eligibility Criteria:
Inclusion Criteria:

* Individuals screened out through social media addiction scale will be used for the experimental study. Both male and female participants will be taken for the study. People with even mild score on social media addiction will be considered eligible for the study. Only people in the age range of 18-22 will be taken as participants in the study

Exclusion Criteria:

* Individuals not within the age range of 18-22 will not be taken as participants.
Effects of a Chewing Gum Containing POs-Ca and Fluoride on Enamel

There were no differences in the degree of enamel remineralization of subsurface lesions among the chewing gums containing or not containing POs-Ca and fluoride.


Eligibility Criteria:
Inclusion Criteria:

* healthy adult subjects
* More than 22 permanent teeth

Exclusion Criteria:

* Alcohol addiction
* Smoking
* Active caries
* Periodontal pockets
* Low-saliva flow (less than 0.3ml/min)
Efficacy of Adding Topiramate to Current Treatment in Treatment-Resistant Generalized Social Phobia (GSP)

SSRI's are considered first-line treatments for GSP, however many patients continue to have significant symptoms despite an adequate trial of an SSRI. Topiramate, a drug, which targets the glutamate system in the brain, has been shown to improve symptoms of social phobia when used on its own and has also been used as an additive treatment in other anxiety disorders. This study will test the efficacy of adding topiramate to a subject's current SSRI in cases of GSP which are considered to be treatment-resistant.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient with primary DSM-IV GSP
* Completion of an adequate trial (14 wks) of open, flexible dose SSRI treatment (fluoxetine 80mg/day, paroxetine 60mg/day, fluvoxamine 300 mg/day, sertraline 200mg/day, citalopram 60mg/day, escitalopram 30mg/day)
* Non or partial response to SSRI treatment (CGI-S \> 4, LSAS \> 40)

Exclusion Criteria:

* Any other DSM-IV Axis I primary diagnosis
* Meeting DSM-IV criteria for body dysmorphic disorder, eating disorder or current alcohol/substance abuse
* A lifetime history of bipolar affective disorder
* A Hx of schizophrenia/psychotic disorders, delirium, dementia, or amnestic/other cognitive disorders
* Borderline/antisocial personality disorder
* A comorbid Axis II cluster A personality disorder
* Hx of \> 3 adequate trials with an SSRI
* score of \> 4 on MADRS q.10
* Current increased risk of suicide
* Prior use of or an allergy to topiramate
* Participation in any clinical trial 30 days prior to entering the study
* Unable to tolerate being free of or shows signs of withdrawal benzodiazepines for 4 weeks
* Hx of seizures, kidney stones or thyroid problems
* BMI \< 20
A Study to Assess Selected Biomarkers in Subjects Requiring Daily Inhaled Corticosteroids for Persistent Asthma

The rationale for conducting this study is to explore potential clinical and peripheral biomarkers in subjects requiring daily medium to high dose inhaled corticosteroids for persistent asthma


Eligibility Criteria:
Inclusion Criteria:

* Age 18 through 75 at the time of screening
* Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
* History of physician-diagnosed asthma for at least 12 months prior to screening
* Stable Medium- to high-dose ICS divided twice daily as outlined by the NHLBI Asthma Guidelines, 2007

Exclusion Criteria:

* Any medical condition that, in the opinion of the investigator or medical monitor, would interfere with interpretation of subject safety or study results
* Concurrent enrollment in another clinical study
* Use of immunosuppressive medication within 3 months prior to screening
* Acute upper or lower respiratory infections requiring antibiotics or antiviral medications with in 30 days prior to screening or during screning period.
* Receipt of immunoglobulin or blood products within 30 days prior to screening or during the screening period
* Receipt of any investigational non-biological drug therapy within 30 days or 5 half-lives prior to screening whichever is longer; or receipt of any marketed or investigational biologic within 6 months or 5 half-lives prior to screening whichever is longer
* Pregnant, lactating, or breastfeeding woman
* Diagnosis of lung disease other than persistent asthma
* History of smoking ≥10 pack years or any smoking within 12 months prior to screening
* History of active, infectious hepatitis A, B, C or human immunodeficiency virus (HIV)
Identifying Risks of COVID-19 Outbreaks in Work Settings and the Implications for Control Measures

Objectives: To identify core and cross-time workplace hazards and worker's exposure prevention profile towards outbreaks in three non-healthcare work settings; to evaluate effectiveness of a theory-based educational programme on improving attitude to vaccination and virus testing in workplace; to longitudinally compare attitude of willingness to vaccination, testing of SARS-CoV-2 and changes of risk profile toward outbreaks among workers.

Design: A 5-year study comprising a randomized controlled trial (RCT) and 3 parallel longitudinal studies with baseline and follow-up repeated measurements.

Setting: Non-office, mobile and office work settings. Participants: Part I is a RCT, 294 workers will be randomised to an intervention group (a theory-based education programme) and a control group with measurements repeated at 3rd, 6th and 9th month. Part II is a longitudinal quantitative study (i.e., prospective cohort study) involving 1,495 workers recruited at the baseline and followed up for 2 years. Part III is a longitudinal qualitative study involving 26 management and frontline workers. Part IV is a longitudinal workplace hygiene study involving 6 workplaces enrolled at the baseline and followed up to conduct ventilation investigation.

Intervention: Theory-based education intervention to build positive attitude of control measures towards SARS-CoV-2 outbreak.

Main outcome measure: Workplace hygiene data (airflow, air volume, etc.); willingness to vaccination and virus tests; actual uptake of SARS-CoV-2 antibody testing.

Data analyses: Multivariate regression logistic model and thematically analysed will be performed for quantitative and qualitative analysis. Intention-to-treat analysis will be employed for RCT.

Expected results: Large dataset of longitudinal measurement of willingness to vaccination/testing and actual uptake will be documented to inform policy. Educational intervention will be developed to mitigate risks of outbreaks in workplace.


Eligibility Criteria:
Inclusion Criteria:

* currently being employed in Hong Kong

Exclusion Criteria:

* who have history of physician-diagnosed cancer and sever chronic diseases
Study on Glucocorticoid Combined With Gamma Globulin and Ropristine N01 in Treatment of Initial Severe ITP

The goal of this clinical trial is to learn if romiplostim N01 works to treat severe primary immune thrombocytopenia in adults. It will also learn about the safety of romiplostim N01. The main question it aims to answer is:

TO evaluate the effectiveness of the combination treatment of glucocorticoids, gamma globulin and romiplostim N01 in patients with severe primary immune thrombocytopenia during the initial treatment period for one month.

Participants will:

Romiplostim N01, starting dose of 1 µg/kg, subcutaneous injection, given on the third day of IVIG, once a week, for up to one month.

IVIG, 400mg/kg/d, intravenous administration, continuous administration for 3-5 days.

Prednisone, 0.8mg/kg/d, taken orally or intravenously, for up to one month.


Eligibility Criteria:
Inclusion Criteria:

1. Participants must sign a written informed consent prior to enrollment;
2. Ages 18-75;
3. Platelet count \<10×10\^9/L with active bleeding or bleeding score ≥5;
4. No contraindications to the use of steroids, romiplostim, or IVIG, and willingness to receive these treatments;
5. No prior splenectomy or at least one first-line ITP treatment or emergency treatment;
6. No prior romiplostim treatment;
7. ECOG PS score: 0-2;
8. Female participants of childbearing potential must agree to use reliable contraception (including male or female condoms, contraceptive foam, contraceptive jelly, contraceptive patches, contraceptive cream, contraceptive suppositories, abstinence, and placement of intrauterine contraceptive devices) throughout the study; women who have had a hysterectomy, bilateral oophorectomy, bilateral salpingo-oophorectomy, or have been postmenopausal for more than 1 year, and men who have had bilateral vasectomy or vasectomy are excluded;
9. Voluntary participation in this study and good compliance.

Exclusion Criteria:

1. Individuals with the following hematological disorders other than ITP, including but not limited to leukemia, thrombocytopenia caused by cancer treatment, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndrome;
2. Individuals with a history of thrombosis;
3. Pregnant or lactating individuals;
4. Individuals with severe cardiopulmonary insufficiency;
5. Individuals with severe or uncontrollable infections;
6. Individuals with viral infections;
7. Individuals who cannot comply due to psychological reasons;
8. Individuals who are deemed unsuitable for participation in the study by the investigator.
Effect of IKERVIS® Eye Drops Once Daily on the Quality of Vision in Dry Eye Disease Patients With Severe Keratitis

The proposed 3-month study is a prospective, open-label, multicentre, phase IV, proof of concept study. The study is designed to assess the effect on the quality of vision of IKERVIS® (1mg/mL ciclosporin) eye drops administered once daily in dry eye disease (DED) patients with severe keratitis, as well as its safety and efficacy.

In this phase IV clinical trial the Month 3 visit assessments will be used to assess the efficacy (quality of vision and other parameters) and safety of IKERVIS® in DED patients with severe keratitis.

To assess the effect on the quality of vision of IKERVIS® (1mg/ml ciclosporin) eye drops administered once daily in adult dry eye disease (DED) patients with severe keratitis over 3 months of treatment.

To assess the safety of DED patients with severe keratitis treated with IKERVIS® (1mg/mL ciclosporin) for 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Patient eligibility is determined according to the following criteria:

  1. In the opinion of the investigator, the patient is capable of understanding and complying with protocol requirements.
  2. The patient signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures
  3. Male or female patient is aged 18 years or above.
  4. DED patients with persistent severe keratitis at the Screening and

     Baseline Visits defined as the following:

     • CFS score of 3, 4 or 5 on the modified Oxford scale
  5. Patient must be willing and able to undergo and return for scheduled study-related examinations.
  6. The same eye (eligible eye) should fulfill all the above criteria.

Exclusion Criteria:

* Patients with history of ocular trauma or ocular infection (viral, bacterial, fungal, protozoal) within 90 days before the Screening Visit and any ocular diseases other than dry eye disease requiring topical ocular treatment during the course of the study.
CMR Features in Patients With Suspected Myocarditis

Presentation of myocarditis is heterogeneous, often ranges from being asymptomatic, to chest pain, dyspnoea, palpitations, and even sudden cardiac death. Diagnosing myocarditis is challenging with no current uniform clinical gold-standard. CMR is a key investigative tool, however the predictive value of CMR features is unknown. In this study we assess 670 consecutive patients with suspected myocarditis who were referred for CMR between 2002 and 2015 at the BWH. CMR features such as late gadolinium sizing, T1 mapping, extracellular volume fraction assessment, strain analysis (feature tracking), clinical data, labortory tetsings and electrocardiogramm are linked to the outcome in order to assess its predictive value.


Eligibility Criteria:
Inclusion Criteria:

* patients referred by their treating physician to undergo CMR for "suspected myocarditis" as the primary clinical question

Exclusion criteria

* evidence of coronary artery disease
* hypertrophic cardiomyopathy
* arrhythmogenic right ventricular cardiomyopathy
* cardiac sarcoidosis
* cardiac amyloidosis
* takotsubo cardiomyopathy
* constrictive pericarditis
* Loeffler endocarditis
* ventricular non-compaction
* cardiac tumor
* pulmonary embolism
* severe valve disease
Evaluating the Occurence of New and Progression of Existing Peripheral Venous Disease in Leg Veins

Peripheral venous disease occurs when a vein becomes damaged or blocked. It can occur almost anywhere in the body, but is most common in the arms and legs. This study will examine people who participated in a previous venous disease study to evaluate changes in leg veins and venous disease status over a period of 11 years.

Peripheral venous disease is a general term for damage, defects, or blockage that occurs in the peripheral veins, which carry blood from the hands and feet back to the heart to receive oxygen. The most common cause of peripheral venous disease is a blood clot that blocks a vein. Varicose veins, which are swollen blood vessels near the surface of the skin, and chronic venous insufficiency, a condition in which blood in the leg veins does not drain properly, are two other common types of peripheral venous disease. From 1996 to 2000, the San Diego Population Study (SDPS) evaluated a group of individuals to gather information on the prevalence of venous disease. This current study will re-evaluate the SDPS participants to document changes that have occurred in their leg veins over the past 11 years, including any new venous disease and any progression of existing venous disease. Study researchers will also evaluate how venous disease relates to risk factors, symptoms, and quality of life issues.

This study will enroll people who participated in the SDPS study. Each participant will attend one study visit. Study staff will conduct a 1-hour interview with each participant to collect information on their medical history, disease-related symptoms, risk factors for venous disease, family health history, health habits, and quality of life. Blood collection will occur, participant's leg veins will be examined and photographed, and blood flow in the legs will be measured with an ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Participated in the SDPS study
Bioequivalence of 5 Tablets of 100 mg Versus 2 Tablets of 250 mg TF3 of Tepotinib

This study investigated the bioequivalence of the 100 milligrams (mg) and 250 mg dose strengths of tepotinib tablet formulation 3 (TF3) when administered at the same dose under fasted condition.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants of non-child bearing potential
* Body weight between 50 to 100 kilogram (kg)
* Body mass index (BMI) between 18.5 and 29.9 kilogram per meter square (kg/m\^2)
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Participation in a clinical study within 60 days prior to first drug administration
* Whole blood donation or loss of greater than 450 milliliter (mL) within 60 days prior to first drug administration
* Any surgical or medical condition, or any other significant disease that could interfere with the study objectives, conduct, or evaluation
* Other protocol defined exclusion criteria could apply
Reconstructions of Chest Wall Defects: a Retrospective Study

Patients requiring thoracic reconstruction often suffer from numerous comorbidities, such as obesity, diabetes, atherosclerosis and cardiovascular diseases, respiratory diseases. The clinical picture of these patients must be carefully stabilized in the preoperative period since the listed diseases are associated with a poor reconstructive outcome. Furthermore, it is necessary to preoperatively determine the spirometric characteristics in cases where the intervention may alter the respiratory dynamics to evaluate the patient's ability to tolerate the procedure. The primary objective of the study is to identify the best diagnostic-therapeutic approach in cases of complex chest wall defects, retrospectively evaluating the outcomes and therapeutic choices implemented, through a reassessment of the interventions performed and the clinical progress of patients undergoing complex thoracic and sternal reconstruction interventions managed in a multidisciplinary and non-multidisciplinary manner

Currently there are no univocal universally accepted guidelines regarding the intervention to be performed in case of complex chest wall reconstructions or for the treatment of sternal wound dehiscences. Different options are described, both for the demolition phase and for the reconstructive phase in the thoracic and sternal area. The choice of one method rather than the other is currently largely based on the experience and preference of the specific working group. The importance of the study lies in the attempt to analyze the choices made in the diagnostic and therapeutic phase (demolitive, reconstructive, pharmacological) on patients treated at the AOU Sant'Orsola (now IRCCS) in past years. The secondary objective of the study is to improve the multidisciplinary management of patients who are candidates for complex chest reconstructions.

In particular, the drafting of a multidisciplinary therapeutic protocol that uses algorithms to optimize the choice of surgical procedure and medical therapy in terms of resolution of the problem, hospitalization times, and patient quality of life.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing sternal or thoracic reconstruction in collaboration or not with the Reconstructive Plastic Surgery Unit
* Obtaining informed consent

Exclusion Criteria:

-