cyrilzakka/clinical-trials huggingface dataset:
GWPCARE2 A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome

To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome.

This study was a 2:2:1:1 randomized, double-blind, 14-week comparison of two dose levels of GWP42003-P (10 milligram/kilogram \[mg/kg\]/day and 20 mg/kg/day) versus placebo (10 mg/kg/day dose-volume equivalent and 20 mg/kg/day dose-volume equivalent; presented as pooled placebo in the study). A 28-day screening period prior to randomization (to establish baseline parameters) preceded the treatment period, which consisted of a 2-week titration period followed by a 12-week maintenance period. The study aimed to determine the efficacy, safety, and tolerability of GWP42003-P compared with placebo. 20 mg/kg/day was recommended by the Data Safety Monitoring Committee (DSMC) after assessment of safety and pharmacokinetic data from Part A of study GWEP1332 (NCT02091206). The first participant did not enroll into this study until the DSMC reviewed the safety data from Part A of study GWEP1332 (NCT02091206).

Following study completion, all participants were invited to continue to receive GWP42003-P in a separate open-label extension study (GWEP1415; NCT02224573).

Eligibility Criteria:
Key Inclusion Criteria:

* Participant must have been male or female, aged between 2 and 18 years (inclusive).
* Participant must have had a documented history of Dravet syndrome that was not completely controlled by current antiepileptic drugs.
* Participant must have been taking 1 or more antiepileptic drugs at a dose that had been stable for at least 4 weeks.
* All medications or interventions for epilepsy (including ketogenic diet and vagus nerve stimulation) must have been stable for 4 weeks prior to screening and participant was willing to maintain a stable regimen throughout the study.

Key Exclusion Criteria:

* Participant had clinically significant unstable medical conditions other than epilepsy.
* Participant had clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to screening or randomization, other than epilepsy.
* Participant was currently using or had in the past used recreational cannabis, medicinal cannabis, or synthetic cannabinoid-based medications (including Sativex®) within the 3 months prior to study entry and was unwilling to abstain for the duration for the study.
* Participant had any known or suspected hypersensitivity to cannabinoids or any of the excipients of the investigational medicinal products.
* There were plans for the participant to travel outside their country of residence during the study.
* Any history of suicidal behavior or any suicidal ideation of type four or five on the Columbia-Suicide Severity Rating Scale (Children's) at screening.
Outcome of URS in Fresh Versus Recurrent Cases of Stone Ureter

Comparison of Ureteroscopy in fresh versus recurrent cases of stone ureter

Urolithiasis is a common cause of both urology outpatient clinic and emergency room encounters. Approximately 75-90% of ureteral stones pass spontaneously. from this point of view other managements of ureteric stones either ESWL, ureteroscopy or open surgery according to location, site, size, and density. Ureteroscopy is commonly used to diagnose and treat kidney and ureteral stones, ureteral strictures, and urothelial cancers. Semirigid URS is the gold standard of treatment for ureteral stones. High success rates and low morbidity have been reported in semirigid URS. but complications still occur in some cases. The possibility to predict their occurrence should influence patient advisement and better case selection. there are many predictors of successful URS as age, gender, previous ESWL, and stone character. In addition, the impacted stone is a risk factor, and it is described in the literature as ureteral wall thickness, higher grades of hydronephrosis, ureteral stricture, polyp, inflammatory reaction, and difficulty to introduce the guide wire. the literature is very poor in illustrating the previous procedures as a predictor of successful URS only seen in very few original articles as second-time URS after any procedure decreases the rate of success, so it is a point of research that Amr Moustafa aims to clarify. Amr Moustafa will conduct a prospective study to evaluate the outcomes of URS for stones in the fresh and recurrent cases.

Eligibility Criteria:
Inclusion Criteria:

* • all cases with middle and lower ureteric stone candidate for endoscopy.

  * Stone 15mm or less.

Exclusion Criteria:

* • Patients with a ureteral stent.

  * Patient refusing participation.
  * Pregnant woman.
  * Active urinary tract infection.
  * Comorbidities prevent intervention including bleeding tendency or uncorrectable coagulation profile.
Aranesp® Monthly Preference Study - 2

The purpose of this study was to evaluate subject preference for Aranesp® administered once monthly (i.e., every 4 weeks (Q4W)) or Procrit® administered once weekly (QW).


Eligibility Criteria:
Inclusion Criteria: - Subjects must have signed written informed consent - Be on Procrit® QW or Q2W for a minimum of 8 weeks - Must currently be on a stable dose of Procrit® (defined as less than 25% change in Procrit® dose over the 4 week period immediately prior to enrollment, with no missed doses) - Have Hgb 10-12 g/dL for at least 4 weeks prior to study start - Have 15 less than GFR less than 89 mL/min/1.73 m2 Exclusion Criteria: - Currently receiving investigational erythropoietic agents - Self-injecting at home with Procrit® - Expected to initiate renal replacement therapy (dialysis or transplantation) within 1 year of study start - Have less than 1 year life expectancy
Safety and Tolerability of Oat Containing Gluten-free Diet

The purpose of this study is to determine the safety and tolerability of oats in gluten free diet.


Eligibility Criteria:
Inclusion Criteria:

* Children over 4 years and adults with celiac disease (diagnosed according to current guidelines)
* Subject is able to fully participate in all aspects of this clinical trial

Exclusion Criteria:

* Known intolerance to oats
* Serious underlying disease other than CD which in the opinion of the investigator may interfere with the subject's ability to fully participate in the study
Acupuncture for Anxiety in Parkinson's Disease

This is a single-center, double-blind, placebo-controlled trial to see if acupuncture can safely and effectively manage anxiety in Parkinson's Disease. Eligible subjects will receive either real or sham acupuncture THREE times weekly for a total of SIX weeks.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Parkinson's Disease by authorized Neurologist.
* Patients 40-75 years of age
* Patients who have significant anxiety symptom
* Patients must be on a stable medication regimen for the treatment of PD

Exclusion Criteria:

* Patients who have had previous acupuncture within the past SIX months
* Patients with dementia, depression, or sleep disorder
* Patients who are currently taking medications known to affect anxiety
LITES Task Order 0005 Prehospital Airway Control Trial (PACT)

The Prehospital Airway Control Trial (PACT) is a proposed 5 year, open label, multi-center, stepped-wedge randomized trial comparing airway management strategies of prehospital trauma patients. The initial airway attempt will be randomized to either usual care (control) or a supraglottic airway management approach (intervention). The primary outcome will be 24 hour survival, with secondary outcomes to include survival to hospital discharge, expected clinical adverse events, airway management performance, ICU length of stay, ventilator days, incidence of ARDS, and incidence of ventilator associated pneumonia. Subjects will be enrolled across approximately 17 prehospital agencies at select LITES Network sites and will enroll a total of 2,009 subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Traumatic injury requiring advanced airway management. Indicators of need for advanced airway management include: a) GCS\<8, b) SpO2\<90 despite supplemental oxygen, b) ETCO2\>60 despite supplemental ventilation, or d) provider discretion.
2. Transport (or intended transport) to an enrolling LITES Trauma Center

Exclusion Criteria:

1. \< 15 years of age
2. Known pregnancy
3. Known prisoner
4. Initial advanced airway attempted by a non-PACT provider.
5. Cardiac Arrest without return of spontaneous circulation (ROSC) at the time of the intervention
6. Caustic substance ingestion
7. Airway burns
8. Objection to study voiced by subject or family member at the scene.

Inclusion and exclusion criteria will be assessed based on information available at the time of enrollment, defined as the time at which enrolling agency provides positive pressure ventilation support. Although all reasonable efforts will be made by the emergency medical crew to either directly witness or obtain documentation of inclusion criteria, due to the nature of the emergency prehospital setting, there may be occasions where the emergency medical crew must rely on verbal report of inclusion criteria from referring hospital or emergency crew. In these instances, if, after subsequent review of outside hospital and/or ground crew documentation, it is determined that the subject did not meet inclusion criteria and/or met exclusion criteria, the subject will remain enrolled in the study based on the intention-to-treat principle.

If a verbal report must be used in lieu of physical documentation or directly witnessing inclusion criteria, documentation of the verbal report will serve as the source documentation for determining eligibility. Verbal reports will be documented in the emergency medical record and will detail the information provided and by whom.
Effects of Cervical Manipulation on Cervical Rotation Motion and Shoulder Rotational Motion and Strength in Overhead Athletes

This study will examine the effects of a single session of a quick stretch technique delivered to the neck on neck and shoulder motion as well as shoulder strength in collegiate overhead athletes.

Athletes participating in sports such as baseball, softball, tennis, swimming, and volleyball, are uniquely predisposed to cervical and shoulder dysfunction due to repetitive, high-intensity movements that require coordination between the cervical spine, shoulder, and upper extremities. These repetitive motions involve extreme glenohumeral (GH) range of motion (ROM) as well as high angular velocities, often leading to adaptations such as Glenohumeral Internal Rotation Deficit (GIRD). Overhead athletes with GIRD are at a higher risk of developing shoulder injuries.

This study aims to assess the effects of cervical spinal manipulation on cervical rotation ROM, GH rotational ROM and strength in overhead athletes. The current body of literature suggests an association between cervical rotation ROM deficits and arm injury risk in professional and collegiate-level baseball players. Restrictions in the cervical spine may alter neural and muscular pathways, potentially contributing to decreased shoulder ROM, compromised strength, and impaired performance. Given the complex interplay of cervical spine and shoulder function, understanding how cervical manipulation impacts the kinetic chain can play a vital role in developing shoulder rehabilitation and preventative programs for overhead athletes.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old and above
* Current overhead college athlete
* No mental health considerations such as generalized anxiety disorder, PTSD, and schizophrenia

Exclusion Criteria:

* Upper extremity surgery in the last year
* Current shoulder pain
* Current neck pain
* Recent episodes of vertigo, dizziness, and migraines
* Recent motor vehicle accident
* History of cardiovascular disease such as hypertension, heart attack, stroke, coronary artery disease, peripheral artery disease, arrhythmias, heart valve disease, congenital heart defects, and aortic aneurysm
* Fear or unwillingness to undergo cervical manipulation
YASU Research Registry: for Young Adults with Cancer

The goal of this observational research registry is to learn about health, wellbeing, and needs of survivors of young adult cancer (diagnosed between the ages of 18 and 39). The main question\[s\] it aims to understand are:

* What are the levels of depression, anxiety, social support, and financial distress
* Determine effectiveness of YASU programming by measuring changes over time

With this registry, the investigators also plan to identify survivors who may be eligible for participation in future research studies pertaining to young adult cancer.

Participants will be asked to complete electronic surveys every 6 to 12 months during participation in the registry.

The study will be conducted online.

Eligibility Criteria:
Inclusion Criteria:

1. Cancer diagnosis received between the ages of 18 and 39.
2. Able to speak and read English

Exclusion Criteria:

1. Inability to provide consent (such as neurological illness or mental incapacity)
2. Has not registered as a member of YASU
Effect of Continuous Anterior Chest Compression on Ventilation/Perfusion Ratio and Hemodynamics

Intro:

The mortality of acute respiratory distress syndrome (ARDS) remains high (40%), and may be aggravated by ventilation-induced lung injury (VILI), the main mechanisms of which are:

1. Anterior region overdistension,
2. Atelectrauma in the posterior regions. Positive expiratory pressure (PEEP) adjusted on the ventilator during ARDS aims to recruit posterior pulmonary territories in order to limit atelectrauma but is accompanied by a concomitant risk of overdistension of anterior territories.

Recent data suggest that continuous anterior chest compression (CACC) could limit the overdistension of the anterior regions by decreasing the compliance of the anterior chest wall and thus the regional transpulmonary pressure, while promoting the redistribution of ventilation to the posterior territories.

The effects of CCAC on ventilation/perfusion ratios and hemodynamics are unknown.

Hypothesis/Objective :

The participants hypothesize that during ARDS, CCAC:

1. Improves ventilation/perfusion ratios by decreasing both anterior territory dead space effect and posterior territory shunt,
2. Induce an improvement in cardiac output by decreasing right ventricular afterload (decrease in capillary compression related to the overdistension of the anterior territories and decrease in hypoxic vasoconstriction of the condensed territories).

Objective:

Primary outcome :

To evaluate the effects of CCAC on ventilation/perfusion ratios during moderate to severe ARDS.

Secondary outcome :

To evaluate the effects of CCAC on hemodynamics : left heart morphology, systolic and diastolic function, cardiac output, right heart morphology, systolic function, pulmonary hypertension, volemia.

Method In patient with moderate to severe ARDS, CACC is performed manually and the pressure applied will be maintained between 60 and 80 cmH2O.

Electrical impedance tomography of ventilation and perfusion will be used for the measurement of the percentage of areas with normal VA/Q ratios, areas of shunt and areas of dead space effect.

Left heart morphology, systolic and diastolic function, cardiac output, right heart morphology, systolic function, pulmonary hypertension, volemia will be evaluated by using echocardiography.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* ARDS moderate to severe according to the Berlin criteria
* Patient receiving continuous sedation and curarization
* Free and informed consent from the patient or family member

Exclusion Criteria:

* Pregnancy
* Adult patient subject to a legal protection measure (tutor, curator, etc.)
* Patients with a pacemaker, automatic implantable cardioverter defibrillator,
* Contraindications to thoracic belt placement (e.g., thoracic or spinal cord trauma, recent thoracic surgery)
* Undrained pneumothorax, bronchopleural fistula
* Hemodynamic instability (i.e., use of intravenous fluids of more than 10 mL/kg or vasopressors 2 mg/h of norepinephrine or 0.5 mg/h of epinephrine)
A Study of Early Robotic Ablation by Substrate Elimination of Ventricular Tachycardia

Ventricular tachycardia (VT) is an abnormal rapid heartbeat which occurs after a heart attack and can cause sudden death. Patients at risk of this rhythm disturbance usually receive an implantable cardioverter defibrillator (ICD) that can prevent death by returning the heart's rhythm back to normal by electrically stimulating the heart but in doing so gives the patient painful and debilitating shocks. The first ICD shock after implantation appears to be a powerful predictor of subsequent shock therapy as well as being a predictor of of increased mortality in patients with primary prevention ICDs. In patients who receive repeated shocks VT ablation is performed to 'burn' the abnormal area of the heart that causes the problem. However, it is often only performed as a last resort as it is technically challenging. We believe that performing VT ablation using the robotic system early after the first episode of VT after ICD implantation, may reduce the number of painful shocks received by the patient and possibly increase life expectancy and quality of life.

200 patients from 5 european countries will be recruited in a prospective, open, randomised trial. Eligible, consenting patients who have experienced their first episode of VT since ICD implantation, will be randomised in a 1:1 manner into treatment arms of either VT ablation or standard 'conventional' therapy and followed-up every 4 months over two years to assess the number of subsequent ICD shocks, hospitalisation, mortality and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Males or females eighteen (18) to eighty-five (85) years old
* ICD implantation for post-infarct primary or secondary prophylaxis
* First episode of VT detected (within monitor zone or therapy (ATP /shock delivered) or by 12 lead ECG if the rate below the detection level of the device.
* Suitable candidate for catheter ablation
* Signed informed consent

Exclusion Criteria:

* Contraindication to catheter ablation
* Ventricular tachycardia due to transient, reversible causes
* Presence of a left ventricular thrombus
* Severe cerebrovascular disease
* Active gastrointestinal bleeding
* Renal failure (on dialysis or at risk of requiring dialysis)
* Active infection or fever
* Life expectancy shorter than the duration of the trial
* Allergy to contrast
* Intractable heart failure (NYHA Class IV)
* Bleeding or clotting disorders or inability to receive heparin
* Serum \[K+\] \<3.5 or \>5.0mmol/L
* Serum Creatinine \>200umol/L
* Uncontrolled diabetes (HbA1c ≥73mmol/mol or HbA1c ≤64mmol/mol and Fasting Blood Glucose ≥9.2mmol/L)
* Malignancy needing therapy
* Pregnancy or women of child-bearing potential not using a highly effective method of contraception
* Unable to give informed consent
* Unable to attend follow-up in ICD clinics
18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery

This is a pilot imaging study in participants treated with stereotactic radiosurgery (SRS) to treat brain metastasis. The purpose of this study is to see whether 18F-Fluciclovine positron emission tomography (PET) can be used as a biomarker to measure response or progression of brain metastasis after SRS.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cancer with radiographic finding of brain metastasis
* Any number of brain metastasis, with all lesions ≤ 2 cm in maximum dimension
* Planned treatment with SRS as per the treating physician team
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Individuals of reproductive potential need to employ two highly effective and acceptable forms of contraception for at least 4 weeks prior to screening and agree to use such a method during study participation up to an additional 1 week following the last 18F-fluciclovine PET

Exclusion Criteria:

* Prior anaphylactic reaction to 18F-fluciclovine
* Radiographic evidence of leptomeningeal disease
* Prior whole-brain radiation therapy
* Inability to undergo MRI (e.g., due to safety reasons, such as presence of a pacemaker)
* Pregnant or positive serum pregnancy test within 14 days of registration
* Individuals expecting to be breastfeeding at the time of 18F-fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation of breastfeeding for 24 hours after the time of imaging is allowed.
* Major medical illness or psychiatric/cognitive impairments, which in the investigator's opinion, will prevent completion of protocol and/or preclude informed consent\*

  * A legally authorized representative (LAR) may consent on a potential participant's behalf in the case of cognitive impairment, if in the investigator's opinion, that impairment would not prevent completion of the protocol.
Developing Microbials to Fight Extended-spectrum Beta-lactamase (ESBL)-Producing Escherichia Coli

This study is to identify and isolate well-defined microbials (non-ESBL E. coli) in an observational setting exploring natural gastrointestinal decolonization of humans colonized with ESBL E. coli.

Antibiotic resistance is a severe threat to contemporary medicine. Effective approaches to fight multi-drug resistant pathogenic bacteria are needed.

This clinical observational study is to investigate whether express extended spectrum beta lactamases (ESBL) E. coli colonizing the human gut can be out-competed by other, ideally pan-sensitive strains (non-ESBL E. coli).

Eligibility Criteria:
Inclusion Criteria:

* travelling to Southeast Asia (India, Bhutan, Nepal, Bangladesh, Myanmar, Thailand, Laos, Cambodia, Vietnam) for a maximum of 4 weeks.

Exclusion Criteria:

* other travelling destinations than mentioned above
* antibiotic use at the first sampling time
* Participants who are not colonized will serve as a control group for microbiome comparison
The Effect of Neuromuscular Electrical Stimulation

The effect of neuromuscular electrical stimulation on muscle atrophy in sedated patients on intensive care was studied. The aim of this study was to explore if electrical stimulation could prevent muscle atrophy.

Patients were included in the study one day after administration when prolonged sedation and ventilation were expected. They were divided into intervention (n=7) and control (n=14) groups. For the intervention group, an intermittent neuromuscular electrical stimulation was applied daily for 30 minutes on the right thigh whereas the left thigh was used as a control. Heart rate, respiration rate, systolic and diastolic blood pressure and oxygen saturation were monitored before, during and after the electrostimulation. Perimeter of the right and left thighs was measured in both groups every 3 days at 5 cm above the upper edge of the kneecap.

Eligibility Criteria:
Inclusion Criteria:

* . Prior to inclusion in the study, an informed consent was given by the family of the patients which was approved by the local Ethics Committee of the Virga Jesse Hospital and was performed in accordance with the standards of the 1964 Declaration of Helsinki.

Exclusion Criteria:

* Patients were excluded from the study if they were still able to move their limb actively in spite of the sedation. Patients were also excluded if they had signs of recent ischemia or infarction for less then seven days. Patients with severe orthopaedic or vascular damage, i.e., fractures or oedema in the lower limbs were also excluded. Patients with an augmented risk for neuro electrical stimulation such as open wounds, hemodialysis or an arterial catheter at the stimulation area were also excluded.