cyrilzakka/clinical-trials huggingface dataset:
Reduction of AF Ablation Induced Thrombo-Embolic Incidence Pilot Study

The REDUCE-TE Pilot study is an international, multicenter, prospective, single arm study to compare the AlCath Flux eXtra Gold ablation catheter regarding the prevention of new subclinical cerebral thromboembolic lesions after Pulmonary Vein Isolation to historical data from the literature.


Eligibility Criteria:
Inclusion Criteria:

* Electrocardiographically documented, symptomatic paroxysmal AF.
* Patients with indication for left atrial ablation of AF according to ESC guidelines for the management of atrial fibrillation.
* Anticoagulation according to clinical routine using coumarin derivates with target INR between 2.0 and 3.0 at least 3 weeks prior to the scheduled ablation procedure or novel oral anticoagulants (NOACs).
* Geographically stable for the duration of the study.
* Willingness and ability to perform written informed consent

Exclusion Criteria:

* Long standing persistent or persistent AF
* CHA2DS2-VASc score ≥ 5
* Prior ischemic stroke or Transient Ischemic Attack
* Previous Pulmonary Vein ablation
* Contraindication for anticoagulation therapy
* Contraindication for Diffusion-Weighted MRI
* Claustrophobia
* Contraindication for transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE, if TEE not possible)
* Implanted cardiovascular device, including but not limited to an atrial or ventricular pacemaker or defibrillator leads, artificial valves, stents, septal or LAA occluders
* Acute coronary syndrome \< 3 months prior to scheduled ablation
* Moderate to severe valvular heart disease
* LA size \> 55 mm (confirming echo at maximum 3 months old)
* Patients with non-controlled heart failure or patients with current and recent (\< 1 month prior to ablation) heart failure
* Ejection fraction \< 35% (confirming echo at maximum 3 months old)
* Conditions that prevent patient's participation in neurocognitive assessment (at physician's discretion)
* Female patients who are pregnant or breast feeding or plan a pregnancy during the course of the study
* Any limitation to contractual capability
* Simultaneous participation in another study
* Age \< 18 years
Efficacy and Safety of Levalbuterol Versus Racemic Albuterol in Asthma

To investigate the Efficacy and Safety of Levalbuterol versus Racemic Albuterol in the Treatment of Acute Asthma.

This study is a double-blind, randomized, active-controlled, multicenter, parallel-group trial of levalbuterol in adult subjects with acute reversible airways disease. Approximately 600 subjects will be enrolled and study participation will consist of 2 periods: Period I (Acute Period): Double-blind treatment in the Emergency Department (ED) or Clinic until disposition, for a maximum of 24 hours of double-blind treatment and Period II (Post-Acute Period): Subjects discharged from the ED or Clinic will continue double blind treatment (with the same treatment provided as rescue medication as MDI) for approximately 10 days. Subjects will be contacted by telephone 30 days post discharge to assess relapse. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects must be at least greater than or equal to 18 years of age at the time of consent.
* Subjects must have history of asthma for at least 6 months.
* Subjects must present to the emergency department (ED) or clinic with forced expiratory volume in one second (FEV1) of 20 to 55% (inclusive) predicted at baseline
* Subjects must have O2 saturation greater than or equal to 90% at room air or with no more than 6 Liters/minute supplemental oxygen and no other cause of wheezing or shortness of breath other than asthma as determined by the physician.
* Prior use of a beta-agonist (e.g., Primatine Mist, albuterol, salmeterol, etc.) within 24 hours of presentation to the ED or Clinic.
* Smoked ≤ 10 pack-years or non-smoker.
* Be in good health with the exception of asthma and not suffering from any chronic condition which might affect their lung function, such as COPD or emphysema.
* Near-normal activity level between exacerbations.
* Subjects who are taking inhaled or systemic corticosteroids must be on a stable dose for at least 21 days prior to study entry.

Exclusion Criteria:

* Subjects who have received treatment for asthma in an ED, Clinic, or Urgent Care Center within 2 weeks prior to study entry.
* Based upon history or physical exam in the ED or Clinic, subjects with known or suspected cause of pulmonary symptoms other than asthma, such as COPD, CHF, pneumonia, pulmonary embolism, or angioedema.
* Subjects with a history of asthma episodes associated with hypercapnia, respiratory arrest, hypoxic seizures, or requiring intubation within 12 months prior to entry.
* Hospitalization for asthma within two months prior to entry.
* Female subjects who are pregnant or lactating.
* Subjects who have a history of a clinically significant psychiatric disorder within the last 3 months, with the exception of mild depression.
* Subjects who have participated in an investigational drug study within 30 days of study entry or have previously participated in the current trial.
Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease

To compare the efficacy of BF2.649 over placebo (12 week Double-Blind Phase) and assess the long term safety and the efficacy maintenance(9 months Open-Label Extension Phase) of BF2.649 in the improvement of excessive daytime sleepiness in patients diagnosed with Parkinson's Disease.

As measured by the change from baseline in the Epworth Scale Scores (ESS) at Week 12 and at Week 51, in patients diagnosed with EDS in Parkinson's Disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a documented history of Parkinson's disease according to UPDRS,fluctuator and non-fluctuator patients, Hoehn and Yahr score \<5;
* stabilized on optimal antiparkinsonian treatments unmodified for 4 weeks prior to study entry;
* presenting an Excessive Daytime Sleepiness as indicated by an ESS\>or=12

Exclusion Criteria:

* Patients with a known diagnosis of other degenerative parkinsonian syndromes (e.g. Progressive supra-nuclear palsy, multisystemic atrophy, corticobasal degenerescence, diffuse Lewy's Body dementia)
* Patients who have shift work, chronic or occasional sleep deprivation, circadian rhythm disorders
* Patients with a severe depression indicated by (BDI\>= 16)or at suicidal risk (BDI item G\>0) or depression treated for less than 8 weeks
* Patients with a cognitive impairment
PKU Low Calorie Drink Study

This study will evaluate the compliance, acceptability, gastrointestinal (GI) tolerance and safety of a lower calorie amino acid based liquid protein substitute for patients with Phenylketonuria (PKU) or hyperphenylalaninemia (HPA).


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 3 years of age or above
* Diagnosed with classical or variant type phenylketonuria (PKU), or hyperphenylalaninemia (HPA)
* Have been compliant in taking at least one amino acid-based, Phe-free protein substitute, providing at least 20g protein equivalent daily, for at least 1 month prior to study commencement
* Have a prescribed daily Phe allowance
* Written informed consent from patient, or from parent / carer if applicable

Exclusion Criteria:

* Pregnant or lactating
* Requiring enteral tube or parenteral nutrition
* Major hepatic or renal dysfunction
* Participation in other studies within 1 month prior to entry to this study
* Allergy to any of the study product ingredients
* Investigator concern around the patient being underweight (e.g.: BMI lower than 18.5kg/m2 for adults) and/or having an eating disorder
* Investigator concern around willingness/ability of patient or parent/carer to comply with protocol requirements
Impact of 0.1% and 0.2% Sodium Hyaluronate on Postoperative Discomfort Following Phacoemulsification Surgery

Primary objective of the study is the assessment of the patients' discomfort following cataract extraction surgery by means of phacoemulsification and intraocular lens implantation.

Participants will be recruited from the Cataract Service of the University Hospital of Alexandroupolis (UHA), the Naval Hospital in Athens, the Papanikolaou General Hospital in Thessaloniki, and Athinaiki General Clinic in Athens in a consecutive-if-eligible basis. By means of a custom computer randomization program all participants will randomly populate either study group \[who will receive fixed combination of tobramycin and dexamethasone (FCTD), (Tobradex, Alcon, Greece) quid for 3 weeks and 0.2 % sodium hyaluronate (Hylogel, Pharmex, Greece) quid for 6 weeks\], and control group \[who will receive Tobradex quid for 3 weeks and 0.1 % sodium hyaluronate (Hylocomod) quid for 6 weeks\].

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of senile cataract with stage 2 or 3 nuclear opalescence according to the - Lens Opacities Classification System III (LOCS-3) grading scale

Exclusion Criteria:

1. Diagnosis or evidence of dry-eye-disease (DED)
2. IOP-lowering medications
3. Former incisional surgery
4. Former diagnosis of corneal disease
5. Diabetes
6. Autoimmune diseases
7. Mental diseases
Study of Infigratinib in Children with Achondroplasia

This is a Phase 2, multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, and efficacy of infigratinib, a fibroblast growth factor receptor (FGFR) 1-3-selective tyrosine kinase inhibitor, in children 3 to 11 years of age with Achondroplasia (ACH) who previously participated in the PROPEL study (Protocol QBGJ398-001) for at least 6 months. The study includes dose escalation with extended treatment, and dose expansion. The study also includes a PK Substudy to fully characterize the pharmacokinetics of infigratinib in children with ACH.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent by participant or parent(s) or legally authorized representative (LAR) and signed informed assent by the participant (when applicable).
2. Diagnosis of ACH, documented clinically and confirmed by genetic testing.
3. At least a 6-month period of growth assessment in the PROPEL study (Protocol QBGJ398-001) before study entry.
4. Ambulatory and able to stand without assistance
5. Able to swallow oral medication.

Exclusion Criteria:

1. Hypochondroplasia or short stature condition other than ACH.
2. In females, having had their menarche.
3. Height \< -2 or \> +2 standard deviations for age and sex based on reference tables on growth in children with ACH.
4. Significant concurrent disease or condition that, in the view of the Investigator and/or Sponsor, would confound assessment of efficacy or safety of infigratinib.
5. Current evidence of corneal or retinal disorder/keratopathy.
6. History of malignancy.
7. Currently receiving treatment with agents that are known strong inducers or inhibitors of CYP3A4 and medications which increase serum phosphorus and/or calcium concentration.
8. Treatment with growth hormone, insulin-like growth factor 1 (IGF-1), or anabolic steroids in the previous 6 months or long-term treatment (\>3 months) at any time.
9. Treatment with a C-type natriuretic peptide (CNP) analog, fibroblast growth factor (FGF) ligand trap, or treatment targeting FGFR inhibition at any time.
10. Regular long-term treatment (\>3 weeks) with oral corticosteroids (low-dose ongoing inhaled steroid for asthma is acceptable).
11. Treatment with any other investigational product or investigational medical device for the treatment of ACH or short stature.
12. Previous limb-lengthening surgery or guided growth surgery.
13. Fracture within 12 months of screening.
Performance and Safety of Bone Substitute MBCP-FS in Maxillary Sinus Lift Procedures

The purpose of this study is to evaluate the performance and to monitor the safety of the bone substitute Macroporous Biphasic Calcium Phosphate-Fibrin Sealant Vapor Heated Solvent/Detergent Treated 4 IU/ML Thrombin (MBCP-FS) in Sinus Lift Procedures . This study will be conducted in two parts: part A evaluates safety and performance of MBCP-FS in bone regeneration i.e. the amount of new bone that is formed and its suitability for dental implant placement. Part B is designed to evaluate long-term safety and performance of the product, i.e. whether the newly-formed bone is suitable to retain implants.


Eligibility Criteria:
Inclusion criteria:

* Written informed consent obtained from the subject prior to participation in the study
* At least 18 years of age
* Partially or totally edentulous with an atrophic posterior maxilla requiring unilateral or bilateral sinus lift before dental implant placement
* In case of bilateral sinus lifts, both sides are operated on the same day.
* Subjects with remaining minimal maxillary bone height between 2 mm and 5 mm at the site with minimal height in the area where implants are planned, and a remaining maxillary bone thickness \>= 5 mm in the area where implants are planned

Exclusion Criteria:

* Previous or coeval major surgical intervention in the targeted area, or major surgical intervention in the targeted area planned within the next 18 months (like Caldwell Luc) (minor interventions like surgical tooth extraction or root tip resections are allowed)
* Surgical tooth extraction in the targeted area less than three months before the SLP
* Maxillary and sinus disorders including: acute sinusitis, chronic sinus pathology, retained root tips, polyps, tumors, and cysts in antral cavity or odontogenic cysts, alveolar scar ablation
* Major occlusal disturbance, like severe bruxism
* Uncontrolled\* periodontal disease
* An inadequate interarch distance requiring an oppositional graft
* Immune system disorders, immunodeficiency or immunosuppression
* Known coagulation disorder
* Uncontrolled\* diabetes mellitus
* Severe hyperparathyroidism
* Receiving long-term anti-inflammatory treatment with NSAIDs or corticosteroids
* Chemotherapy current or in the last three months
* Having undergone maxillary radiation therapy
* Known hypersensitivity to aprotinin or to other components of the investigational product
* Abuse of alcohol or drugs or tobacco consumption of more than 5 cigarettes per day at study start
* Non-compliant for future dental hygiene
* Severely compromised physical and psychological health, that in the investigators opinion will affect patient compliance
* Any contra-indications to the use of MBCP, which are defined as osteomyelitis, degenerative bone disease or necrosis of the recipient site
* Concurrently participating in another clinical trial and having received another investigational drug or device within the last 30 days
* Pregnant or lactating, or intending to become pregnant during the study period

  * Uncontrolled = not treated or not stabilized after treatment
68Ga-NY104 PET/CT Guided Radiation Therapy in CcRCC.

Radiation therapy (RT) is an effective treatment for patients with advanced-stage clear cell renal cell carcinoma (ccRCC). Current evidence has shown promising outcomes combining radiation therapy and standard systemic therapy in patients with metastatic/recurrent ccRCC. CAIX is a highly sensitive and specific biomarker expressed on ccRCC and in previous studies the investigators have shown excellent diagnostic efficacy of 68Ga-NY104, a CAIX-targeted PET tracer, in patients with metastatic ccRCC. In this study, the investigators aim to investigate the effect of 68Ga-NY104, and 18F-FDG PET/CT guided RT combining standard systemic therapy in patients with metastatic ccRCC.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Histologically or cytologically confirmed clear cell renal cell carcinoma
* Eligible for radiation therapy: no more than 10 lesions in total
* Expected survival: over 3 months
* ECOG: 0 or 1
* Sufficient organ function
* Written informed consent

Exclusion Criteria:

* Brain metastasis/carcinomatous meningitis
* Other malignant tumors that are not controlled within 5 years, except for non-metastatic low-risk prostate cancer.
* Pregnant or breastfeeding.
* Active infection.
Foundational Ingredients of Robotic Gait Training for People with Spinal Cord Injury During Inpatient Therapy

The FIRST project compares the dose of robotic gait training (RGT) with usual care gait training for patients with spinal cord injury (SCI) undergoing rehabilitation at Baylor Scott \& White Institute for Rehabilitation (BSWIR).

Spinal cord injury (SCI) due to trauma is estimated to affect 288,000 - 500,000 Americans, with about 17,700 new cases annually. Recovery of walking is a primary rehabilitation goal for patients and encouraged by therapists due to its relationship to quality of life, impact on health, psychological profile, and social participation after SCI. Recent technological advances with exoskeleton devices specifically for gait training may yield better walking recovery outcomes compared with usual care intervention approaches, such as body-weight support treadmill training (BWSTT) and overground gait training with braces, yet limited evidence exists for those with SCI.

Aim 1: Use a Community-Based Participatory Research approach to develop an robotic gait training (RGT) program that meets the unique needs of people after incomplete SCI during inpatient rehabilitation. This will be achieved by establishing and engaging an Advisory Board of key stakeholders to review evidence-based literature, advise the research team on the unique aspects and goals of inpatient rehabilitation for people with SCI, review the RGT, and make recommendations for amendments to the RGT program based on our interim and final outcomes of the study over the funding period.

Aim 2: Prospectively examine the efficacy of RGT compared to usual care gait training during inpatient rehabilitation in people with incomplete SCI.

Aim 3: Compare the intensity of RGT and usual care gait training during inpatient rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* 16 - 85 Years of Age
* All types of incomplete Spinal Cord Injury (SCI) (traumatic and non-traumatic)
* Acute/Subacute phase of recovery
* Medically stable as deemed by physician
* Undergoing medical care and inpatient rehabilitation at BSW
* Both genders and all races and ethnicities
* Meet the Ekso robotic exoskeleton frame limitations
* Continence of or a program for bladder and bowel management

Exclusion Criteria

* Moderate to Severe Traumatic Brain Injury (TBI)
* Degenerative diagnoses
* Wound located in proximity to the exoskeleton frame
* Severe osteoporosis/-penia as shown with dual energy x-ray absorptiometry (DXA)
* Pre-morbid developmental disability, significant psychological diagnosis, or other cognitive impairment
Study of Positive Psychology and Effects on Well-being of Anaesthesiologists in Hong Kong

This clinical trial aims to evaluate whether positive psychology interventions via a hybrid approach will enhance well-being and resilience amongst anaesthesiologists in Hong Kong.

The main questions it aims to answer are:

* Is app-based positive psychology intervention effective in improving well-being of physicians?
* Is app-based positive psychology intervention feasible amongst busy healthcare professionals?

Participants will be randomized to one of the two groups:

* Four-week web-based interventions
* Control group

Researchers will compare the intervention and control groups to see if the participants' benefit from the positive psychology intervention compared with not receiving it.


Eligibility Criteria:
Inclusion Criteria:

* Fellows/members of The Hong Kong College of Anaesthesiologists

Exclusion Criteria:

* No exclusion criteria is applied
Comparison of the Efficacy of Double Monopolar Versus Interleaving Stimulation Modes for Pallidal Deep Brain Stimulation

The aim of the study is to compare the efficacy and the safety profile of the newly introduced interleaving stimulation mode to those of the standard double monopolar stimulation mode during pallidal deep brain stimulation of primary generalized or segmental dystonia.

Background:

For the treatment of drug-refractory dystonia, bilateral pallidal deep brain stimulation (GPi-DBS) is proven to be an efficient option. On average, 40-55% improvement on dystonia rating scales (DRS) could be achieved according to the results of multicenter trials lasting for years. However, a considerable portion (10-25%) of the patients experience minimal alleviation despite of good electrode placement. These patients can be regarded as non-responders to GPi-DBS defined as having either limited improvement (\< 25% on DRS) or worsening. Besides adjusting the amplitude, frequency or pulse-width of stimulation, one can change the electrode configuration from the commonly applied single monopolar stimulation mode (one contact on the electrode is negative) to either double monopolar stimulation (two -usually adjacent- negative contacts on the electrode are stimulated with same amplitude and pulse-width values) or bipolar stimulation mode (one contact on the electrode is positive) in case of unsatisfactory outcomes. Although these techniques had been utilized in multicenter trials, non-responsiveness to GPi-DBS did occur. Recently the investigators have reported in the Movement Disorders that the newly introduced interleaving stimulation mode was superior to single or double monopolar stimulation in four patients who had initially (6-12 months after implantation) limited response to GPi DBS.

Aims of the study:

To systematically compare the efficacy and the side-effect profile of double monopolar stimulation mode to those of interleaving stimulation mode in a prospective, randomized, double-blind, and cross-over study.

Methods:

The investigators would enroll 20-25 patients with drug refractory segmental or generalized primary dystonia undergoing bilateral GPi-DBS implantation within a 2-3 year time frame. The inclusion and exclusion criteria would follow those of the study of Kupsch et al.

Eligibility Criteria:
Inclusion Criteria:

* ages of 7 and 75 years
* marked disability owing to primary generalized or segmental dystonia, despite optimal pharmacologic treatment
* disease duration of at least 5 years.

Exclusion Criteria:

* previous brain surgery;
* cognitive impairment (\< 120 points on the Mattis Dementia Rating Scale)
* moderate-to-severe depression (\> 25 points on the Beck Depression Inventory)
* marked brain atrophy as detected by magnetic resonance imaging
* other medical or psychiatric coexisting disorders that could increase the surgical risk or interfere with completion of the trial