cyrilzakka/clinical-trials huggingface dataset:
Safe and Timely Antithrombotic Removal - Direct Oral Anticoagulants Apixaban & Rivaroxaban (STAR-D)

Prospective, Multicenter, Double-blind, Randomized, Study to Evaluate DrugSorb-ATR Removal of Apixaban and Rivaroxaban to Reduce Likelihood of Serious Bleeding in Patients Undergoing Urgent Cardiothoracic Surgery


Eligibility Criteria:
Inclusion Criteria:

1. Male or female age 18 years or older, with documented full, written informed consent
2. Requiring cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB) within 36 hours from last dose of either apixaban or rivaroxaban (\*note that patients must be taking apixaban or rivaroxaban for one of the following indications: a) reduction of stroke/systemic embolism in nonvalvular atrial fibrillation, or b) initial or extended treatment of venous thromboembolism)

Exclusion Criteria:

1. \>48hrs between last apixaban or rivaroxaban dose and start of CT surgery
2. Patients on low dose apixaban or rivaroxaban for prophylactic indications
3. Heart-lung transplant procedures
4. Procedures for ventricular assist device (i.e., implant or revision of LVAD or RVAD)
5. Any of the below conditions that pose a known risk for increased bleeding

   1. Heparin induced thrombocytopenia
   2. Preoperative platelet count \<50,000u/L
   3. Hemophelia
   4. INR greater than or equal to 1.8
6. Prohibited concomitant antithrombotic medications as defined in the study protocol
7. Acute sickle cell crisis
8. Known allergy to device components
9. Active (untreated) systemic infection
10. History of major organ transplantation and those currently receiving immunosuppressive medication or who are profoundly immune suppressed
11. Women with positive pregnancy test during current admission or who are breast-feeding
12. Life expectancy \<30 days
13. Inability to comply with requirements of the study protocol
14. Treatment with investigational drug or device within 30 days of current surgery
15. Previous enrollment in this trial
A Study to Compare Subcutaneous Versus Intravenous Administration of RoActemra/Actemra (Tocilizumab) in Participants With Moderate to Severe Active Rheumatoid Arthritis

This randomized, double-blind, parallel group study compares the efficacy and safety of subcutaneous (sc) versus intravenous (iv) administration of tocilizumab in participants with moderate to severe active rheumatoid arthritis. Participants were randomized to receive either tocilizumab 162 mg sc weekly plus iv placebo every 4 weeks, or tocilizumab 8 mg/kg iv every 4 weeks plus sc placebo weekly during the double-blind period from baseline to Week 24. The double-blind period was followed by a 72-week open-label treatment with some switching of sc and iv administration. No placebo was administered in the open-label phase. Participants continued on their stable dose of disease-modifying antirheumatic drugs (DMARDs) throughout the study. Anticipated time on study treatment was 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants, ≥ 18 years of age
* Rheumatoid arthritis of ≥ 6 months duration, according to American College of Rheumatology (ACR) criteria
* Swollen joint count (SJC) ≥ 4 (66 joint count), tender joint count (TJC) ≥ 4 (68 joint count) at screening and baseline
* Inadequate response to current DMARD therapy
* Permitted DMARDs must be at stable dose for ≥ 8 weeks prior to baseline
* Oral corticosteroids (≤ 10 mg/day prednisone or equivalent) and NSAIDs (up to maximum recommended dose) must be at stable dose for ≥ 4 weeks prior to baseline

Exclusion Criteria:

* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization
* Rheumatic autoimmune disease other than RA
* Functional class IV (ACR classification)
* Diagnosis of juvenile idiopathic arthritis (JIA) or juvenile rheumatoid arthritis (JRA) and/or RA before the age of 16
* Prior history of or current inflammatory joint disease other than RA
* Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
* Previous treatment with tocilizumab
* Active current or history of recurrent infection
PPG to Predict Ejection Fraction and Other Echographic Data in the General Population

The investigators are aiming to investigate the association between ejection fraction (EF) determined by echocardiography and signals obtained from Photoplethysmography (PPG) in the general population. The investigators are also aiming to investigate the association between blood pressure and signals obtained from PPG in the general population.

Finally, the investigators are also aiming to investigate the association between signals obtained from PPG in the general population to cardioechographic findings such as, valvular heart disease, structural heart diseases, cardiomyopathies, pericardial disease etc.

The investigators are proposing a cross-sectional cohort study, where any individual, 18 years old or older, scheduled for an echocardiography at Tulane University's outpatient cardiology clinic can be included. After consenting participants, information on their demographics, personal health habits, medications, and medical history will be collected via reviewing, their electronic medical health records. All participants will undergo an echocardiography as part of their routine medical care by their treating physician. Important echocardiographic findings will be noted such as, EF, valvular heart disease, pericardial disease, cardiomyopathies and structural heart disease. Additionally, PPG recordings will be collected simultaneously while performing echography using the Biostrap wristband.

The investigators will analyze the association between each echographic imaging feature, and the PPG waveform obtained. PPG waveform features will be used to develop a predictive model capable of calculating an estimate of ventricular ejection fraction without echocardiography. All echocardiograms will be performed by experienced operators at Tulane Medical Center facilities. The study will occur at a single study site Tulane Medical Center and clinics, with appropriate facilities and equipment to conduct the study accurately and safely.

An experienced echocardiogram technician or cardiology fellow will collect the PPG recordings using the Biostrap application. De-identified echocardiogram reports, including information on LVEF will be matched with the participant's pulse report.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female aged18 years or older.
* Patients scheduled to undergo an echocardiogram at Tulane Medical Center.

Exclusion Criteria:

* Participants under 18 years of age.
* Participants with cognitive impairments.
* Participants with a physical inability to wear the Biostrap during the echocardiogram.
* Individuals who cannot read, speak, and/or understand English.
Zephyr Valve Japan Post-Marketing Surveillance

This is a multicenter, prospective, observational surveillance enrolling 140 consecutive patients with severe emphysema who are candidates for bronchoscopic lung volume reduction using Zephyr Endobronchial Valve at up to 20 centers across Japan and followed for 12 months.

This is a multicenter, prospective, observational surveillance across 20 centers in Japan enrolling 140 consecutive adult patients with hyperinflation of the lungs due to severe emphysema who are considered to be appropriate candidates for BLVR using Zephyr Endobronchial Valve (EBV, Pulmonx Corporation) and confirmed to have little to no collateral ventilation in the target lobe.

Enrolled (consented) subjects will undergo a bronchoscopy procedure with the Chartis assessment to confirm that little to no collateral ventilation is present (CV- status) followed by EBV placement in the most diseased lobe. Subject will be hospitalized for a minimum of 3 nights for observation and followed up for 12 months.

Subjects with collateral ventilation will be exited from the surveillance without treatment.

The primary endpoint is incidence rate of pneumothorax at Day 45 post-index procedure.

The effectiveness will be evaluated from Baseline to specified timepoint based on changes in lung function, exercise capacity, dyspnea and quality of life. A high-resolution computed tomography (HRCT) will be performed at Day 45 and Month 12 to determine Treated Lobe Volume Reduction (TLVR). Lung function will be assessed at Month 3, 6 and 12 by measuring post-bronchodilator forced expiratory volume in 1 second (FEV1), residual volume (RV) and 6 Minutes Walking Distance. The safety will be evaluated based on incident rate of treatment emergent adverse events through Month 12.

Subjects will be required to complete a pulmonary rehabilitation program between Day 45 and Month 3 per local/national guidelines.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is deemed eligible for BLVR using Zephyr Valve, as determined by their treating physician in accordance with Japanese guidelines and approved instruction for use. These include:

   * Recent respiratory rehabilitation completed within the last 6 months
   * Not actively smoking (for at least 4 months)
   * TLC ≥ 100%
   * RV ≥ 175%
   * FEV1 15-45% post-bronchodilator
   * 6MWD 100-500 m
   * mMRC score ≥ 2
   * No coagulation disorder
   * No evidence of active respiratory infection
2. Patient has little to no collateral ventilation (CV-) between the target and ipsilateral lobe as confirmed by Chartis prior to undergoing BLVR.
3. Patient is willing and able to provide informed consent to allow data collection.

Exclusion Criteria: None
Real-time Continuous Cardiac Output Measurements

Study to assess the feasibility of real-time automatic cardiac output measurements using transthoracic echocardiography (TTE)

Rationale: Study to assess the feasibility of real-time automatic cardiac output measurements using transthoracic echocardiography (TTE)

Objective: To assess the correlation and feasibility of real-time automatic continuous cardiac output measurements using transthoracic ultrasound (TTE) in adult ICU-patients in comparison to Flotrac measurements

Study design: prospective, feasibility study

Study population: Adult Intensive Care patients ( \> 18 years)

Intervention (if applicable):

Consecutive adult patients on the ICU in which the there is an indication for continuous cardiac output measurements.

Main study parameters/endpoints:

* Percentage of patients in which continuous cardiac output can be measured using TTE
* Correlation between continuous TTE and Flotrac measurements

Eligibility Criteria:
Inclusion Criteria:

* Adult Intensive Care patients ( \> 18 years)

Exclusion Criteria:

* Pregnancy
* Atrial fibrillation or other irregular heart rhythm
Bile Duct Drainage After ERCP Failure: EUS-BD vs PTBD

The vast majority of patients with distal biliary, pancreatic head or uncinate process cancer have jaundice caused by distal malignant obstruction (DMO) of the common bile duct. Biliary drainage by Endoscopic Retrograde Cholangiopancreatography (ERCP) with trans-papillary stent placement is the treatment of choice.

ERCP has a failure rate ranging from 12 - 25 percent. Percutaneous transhepatic biliary drainage (PTBD) is the alternative conventional way to drain the biliary tree after ERCP failure, which is related with substantial morbidity (62%) and mortality (17%). Endoscopic ultrasound (EUS)-guided biliary drainage (EUS-BD) is a novel promising drainage modality with reported excellent outcomes in terms of clinical success and complications.

The implementation of EUS-BD besides ERCP and PTBD into Dutch daily clinical practice raises many questions related to performance, costs, QoL, training, implementation and overall oncological treatment success. This structured learning/proctoring program with an additional national registry provides insights into EUS-BD and how to implement EUS-BD in the Dutch standard of care.

The study is designed as a prospective multicenter registry. The data obtained in this study will enable the EUS-BD procedure to progress to larger multicenter and preferably randomized control trials.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Distal malignant CBD obstruction (from ampulla to 1cm distal to the hilum)
* Indication for biliary drainage after failed ERCP-guided biliary drainage

Exclusion Criteria:

* Previous PTBD and/or EUS-BD
* Inability to provide informed consent
* Pregnancy
* American Society of Anesthesiology (ASA) Grade IV-V
Study of Corneas Undergoing Balanced Salt Solution(BSS ®) Versus Glucose-bicarbonate-Ringer Lactate in Cataract Surgery

This is a study aimed at evaluating the effectiveness and impact of two intraocular irrigating solution (BSS ® versus glucose-bicarbonate-Ringer Lactate - GBRL) on the health of the cornea after cataract surgery by phacoemulsification.


Eligibility Criteria:
Inclusion Criteria:

* Uncomplicated senile cataract
* Visual acuity (VA) between 20/40 and 20/400
* Healthy corneas

Exclusion Criteria:

* Mental incapacity
* Patients with coexisting diseases of the cornea
* Presence of corneal opacity
* Uncontrolled glaucoma
* Uncontrolled diabetes mellitus
* Uveitis
* Cells or flare in the anterior chamber
* Prior intraocular surgery
* Patients using topical steroids or systemic
* Traumatic cataract, hereditary or toxic
Investigation of Drug-drug Interaction Between Clopidogrel and Fluoxetine

Clopidogrel is a platelet aggregation inhibitor witch prevents thrombotic events in patients with atherosclerotic vascular disease. To date, 4 to 30 % of patients are considered as poor, low or non-responder to this therapeutic. However, drug-drug interactions may lead to decrease the clopidogrel responsiveness. Many arguments are in support to a drug-drug interaction between clopidogrel and fluoxetine (selective serotonin reuptake inhibitor). On the pharmacokinetic level, fluoxetine inhibits the cytochroms involved in the production of clopidogrel active metabolite. On the pharmacodynamic level fluoxetine could increase the risk of hemorrhage by inhibiting the serotonin platelet reuptake and thus enhance the antiplatelet effect of clopidogrel.

The purpose of this study is to investigate the influence of fluoxetine on pharmacokinetic and pharmacodynamic of clopidogrel.


Eligibility Criteria:
Inclusion Criteria:

* Signed an informed consent
* Body mass: 60 to 85 Kg
* Platelet count: 180 to 350 G/L
* % platelet aggregation \> 70%
* Subjects are to be in good health as determined by a medical history, physical examination including vital signs, and clinical laboratory test results including liver function, renal and full blood count

Exclusion Criteria:

* Subject with an history of seizure disorder
* Subject with a known allergy fluoxetine or clopidogrel
* Cigarette smoking
* Subject with a history of hemorrhagic disease
* Peptic ulcer
* Psychiatric disorders
* Participation in another clinical or device trial within the three previous months
* Subject who is currently taking medications
* Subject who is currently taking medications for depression
* Subject with an history of depression (MADRS score \< 15)
* Hepatic insufficiency
Efficacy and Safety Study of Glucosamine/Chondroitin Sulfate to Patients Treatment With Osteoarthrosis of the Knee

The purpose of this study is to assess the efficacy and safety of glucosamine and chondroitin sulfate association in the treatment of patients with osteoarthrosis of the knee.

To assess the efficacy and safety of the association of glucosamine sulphate 500 mg/chondroitin sulphate 400 mg (Eurofarma) in the treatment of osteoarthritis, compared to Cosamin DS® (Nutramax) in same presentation and pharmaceutical form.

Some eligibility criteria:

Osteoarthritis of the knee confirmed by radiological examination; Visual analogue scale (VAS) \> 40 mm; Clinical diagnosis of pain and functional limitation

Eligibility Criteria:
Inclusion Criteria:

* Subjects have to read and sign the approved the Informed Consent form prior to any participation in the study.
* Male or female Subjects, aged upper to 40 years.
* Osteoarthritis of the knee confirmed by radiological examination.
* Visual analogue scale (VAS) \> 40 mm.
* Kellgren and Lawrence grade 1 to 3.
* Clinical diagnosis of pain and functional limitation.

Exclusion Criteria:

* History of significant trauma or surgery in the affected joint.
* Pregnant women, lactating or not using appropriate contraceptive method.
* History or presence of active rheumatic disease that may be responsible for secondary osteoarthritis.
* Severe inflammation of the joint confirmed by physical examination (excluding also erythrocyte sedimentation \<40mm/h and rheumatoid factor \<1:40).
* Body mass index \> 30.
* Hematologic abnormalities, liver, renal or metabolic functions which undermine the serious participation of the patient (at investigator's criteria).
* Systemic administration and/or intra-articular corticosteroids in the last 3 months.
* Have made use of glucosamine and/or chondroitin.
* Lequesne index of \> 12.
* Arthroplasty in the affected joint.
* Use of narcotic analgesics.
* Any condition that, in the opinion of the investigator, renders the patient unable to participate in the study.
Prospective Pilot Trial to Address Feasibility and Safety of Oral Zinc in GNAO1 Associated Disorders

The goal of this clinical trial is to investigate feasibility and safety of an oral therapy with zinc in patients affected by Guanine nucleotide-binding protein G(o) subunit alpha (GNAO1) associated disorders.

The main questions it aims to answer are:

* Is a daily oral therapy with zinc in GNAO1 associated disorders a safe and feasible therapy?
* Are there potential changes in general motor skills, general behaviour and well being, day/night rhythm, level of dyskinesia and dystonia, frequency of seizures, quality of life and changes in the microbiome of the patients.

Participants with GNAO1 associated disorders will be given an oral zinc therapy for 6 month and will be assessed in 3 visits and 2 phone calls within this trial.


Eligibility Criteria:
Inclusion Criteria:

* GNAO1 associated neurological disorder, documented by either

  * Proven pathogenic or likely pathogenic mutation in GNAO1 or
  * a variant of unknown significance in GNAO1 and clinical symptoms likely to be consistent with GNAO1 as determined by the investigators and
  * at least one of the common symptoms of GNAO1: Movement disorder (Dystonia, Chorea, Ataxia, clonic), central muscular hypotonia, epilepsy, global developmental delay
* Age: 6 month - 30 years
* GMFM ≤ 75
* written informed consent prior to any trial-related procedure (according to age and status of psycho-intellectual development)

  * of parents or legal guardian
  * of parents or legal guardian and patient
  * of the patient
* stable on following concomitant treatments for at least 3 months prior to trial inclusion: anti-seizure drugs (ASD); baclofen, Deep brain stimulation settings

Exclusion Criteria:

* Treatment of Zinc in the last 4 months before inclusion
* known other genetic variants that are known to cause symptoms like observed in GNAO1-related disorders, additional to the proven GNAO1 mutation
* implantation of Deep brain stimulation planned during the duration of the trial, i.e. in the six months after inclusion
* start of intrathecal baclofen therapy planned during the duration of the trial, i.e. in the six months after inclusion
* Known allergy/hypersensitivity to the scheduled trial drug
* Concomitant participation in other clinical drugs with investigational drugs or with competing interventions
* sexually active patients who are not willing to use/ not using a highly effective contraception method with a pearl-index \< 1. Sexually active patients, unless surgically sterile, must be using a highly effective contraception method (including oral, transdermal, injectable or implanted contraceptives, intrauterine device (IUD), using a condom of the sexual partner or sterile sexual partner) and must agree to continue using such precautions during the whole study period.
* Pregnant women and nursing mothers
Effects of Laser Therapy and LED Therapy on Elderly Individuals With Temporomandibular Disorder

Temporomandibular disorder (TMD) is described as a subgroup of orofacial pain with a set of signs and symptoms that involve the temporomandibular joint, masticatory muscles, ears and neck. TMD can occur unilaterally or bilaterally and approximately 70% of the population is affected with at least one sign. The disorder progresses with orofacial pain, muscle pain involving the masticatory and cervical muscles, joint noises (clicks and pops), joint block, mandibular dysfunction and headache. The etiology can be abnormal occlusion and/or posture, trauma involving local tissues, repetitive microtrauma, parafunctional habits and an increase in emotional stress. Studies have demonstrated that phototherapy is an efficient option for the treatment of TMD, leading to improvements in pain and orofacial function. The aim of the proposed study is to analyze the effects of low-level laser therapy and light-emitting diode (LED) therapy on pain and function in patients with TMD. Methods: A randomized, controlled, double-blind, clinical trial is proposed, which will involve 80 individuals between 40 and 70 years of age allocated to either a laser group or LED group submitted to twelve sessions of phototherapy. The Research Diagnostic Criteria for TMDs will be used to evaluate all participants. Pain will be measured using the visual analog scale. Orofacial function will be measured based on maximum vertical mandibular movement and muscle tension (determined through palpation of the masseter, temporal, frontal, sternocleidomastoid, suboccipital and trapezius muscles). Electromyographic analysis of the masseter and anterior temporal muscles will also be performed.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of TMD based on the RDC/TMD;
* Age between 40 and 70 years.

Exclusion Criteria:

* Dentofacial anomalies;
* Currently in orthodontic or orthopedic treatment for the jaw;
* Currently undergoing physical therapy;
* Currently undergoing psychological treatment;
* Use of muscle relaxant or anti-inflammatory agent.
Varicocelectomy: Can Sex-hormones Predict Improvements in Semen Quality?

The purpose of this study is to determine if the pre-operative levels of sex-hormones can be used to identify the varicocele patients who can expect improvements in their semen parameters following varicocelectomy.


Eligibility Criteria:
Inclusion Criteria:

* Varicocele (grade 1-3) and surgery planned for this condition
* At least 18 years of age

Exclusion Criteria:

* Fever within 3 months before the first semen sample
* Malformations of the uro-genital tract
* Karyotype other than 46, XY or Y micro deletions
* Endocrine disease
* Chronic disease
* Medications which reduce semen quality
* Epididymitis within 6 months before surgery
Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis

Matrix metalloproteinases (MMPs) have been implicated in the cartilage degradation. PG-530742 inhibits some MMPs, potentially limiting cartilage degradation and disease progression. This study will test the efficacy and safety of PG-530742 in the treatment of mild to moderate knee osteoarthritis.

Matrix metalloproteinases have been implicated in the cartilage degradation that occurs in osteoarthritis. PG-530742 inhibits some of these matrix metalloproteinases, thus potentially limiting cartilage degradation and disease progression. This study will test the efficacy and safety of PG-530742 in the treatment of mild to moderate knee osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

* mild to moderate knee osteoarthritis confirmed by a radiographic technique.

Exclusion Criteria:

* secondary knee osteoarthritis;
* diseases other than osteoarthritis that could cause knee pain;
* any disease or intervention (surgery, intra-articular injection) that would have an impact on knee pain or mobility;
* drugs that act potentially on the bone or cartilage component of the knee joint.