cyrilzakka/clinical-trials huggingface dataset:
Fibrinolytic Therapy Versus Medical Thoracoscopy

The purpose of this prospective randomized clinical trial is to compare two currently accepted standard-of-care treatment strategies: medical thoracoscopy as compared to instillation of intrapleural tissue plasminogen activator (TPA) and human recombinant deoxyribonuclease (DNase) for the management of complicated pleural infections in adults as defined as complicated parapneumonic effusions or pleural empyema.

Pleural infection (empyema or complex parapneumonic effusion \[CPPE\]) represents one of the common clinical diagnoses encountered in clinical practice in the United States (US) and worldwide. The incidence of pleural infection continues to rise with an annual incidence of approximately 65,000 in the US and United Kingdom (UK). It is associated with substantial morbidity and mortality as well as increased hospital costs despite advances in medical diagnostic and therapeutic strategies. The overall mortality of pleural infection approaches 20% and it is above 30% in elderly patients over 65 years and immunocompromised patients.

Treatment of CPPE or empyema requires antibiotics and drainage of the pleural cavity.3 However, in about 30% of cases, it is difficult to remove the fluid due to loculations, septations and increased viscosity of the pleural fluid, and around 20% will need surgical intervention to adequately treat the pleural infection.

Specific Aim 1:

To compare the efficacy of early medical thoracoscopy versus fibrinolytic therapy (tPA/DNase) in patients with complicated parapneumonic effusions or pleural empyema.

CPPE is defined as non-purulent effusion in a patient with clinical evidence of infection such as fever and/or elevated blood leukocyte count and/or elevated CRP, with pleural fluid pH ≤ 7.2 (measured by blood-gas analyzer), or pleural fluid glucose \< 60 mg/dl or pleural fluid LDH \>1000 IU/L26. Empyema is defined as pus within the pleural space and/or presence of bacteria on pleural fluid Gram stain or culture.

For patients to be considered for the trial they need to fulfill one of the following criteria: 1) CPPE along with evidence of septated pleural effusion on pleural ultrasonography and/or chest CT scan or 2) empyema.

Eligibility Criteria:
Inclusion Criteria:

1. CPPE along with evidence of septated pleural effusion on pleural ultrasonography and/or chest CT scan
2. empyema.

Exclusion Criteria:

1. age \<18 years;
2. Pregnancy
3. inability to give informed written consent;
4. previous thoracic surgery or thrombolytic therapy for pleural infection;
5. medical thoracoscopy cannot be performed within 48 hours;
6. inability to tolerate procedure due to hemodynamic instability or severe hypoxemia;
7. inability to correct coagulopathy;
8. presence of a homogeneously echogenic effusion on pleural US27 -
Autobiographical Specificity

Autobiographical memory is diminished in patients with Alzheimer's Disease and those with behavioral variant of frontotemporal dementia, and research has focused on the hampered ability of patients in retrieving specific memories. However, this study proposes a detailed methodology to provide a qualitative analysis of autobiographical specificity.

Patients with Alzheimer's Disease and those with behavioral variant of frontotemporal dementia will be invited to retrieve autobiographical memories. Memories will be analyzed and categorized into specific, categoric, extended, or semantic autobiographical retrieval.

Eligibility Criteria:
Inclusion Criteria:

* Alzheimer' disease or avioral variant of frontotemporal dementia
* No opposition from the patient to be included in the study
* For Alzheimer's patients: a score of more than 24 out of 30 on the Mini Mental State Examination (McKhann et al., 1984)

Exclusion Criteria:

* Other psychiatric/neurological disorders
* Minor patients
* Adults under guardianship or protection.
Characterization of Changes in Ventricular Mechanics in Response to Lexiscan Stress Using Tagged Cine Cardiac Magnetic Resonance Imaging

The purpose of this study is to measure the changes in cardiac function during a Lexiscan pharmacologic stress test using cardiac magnetic resonance imaging test.


Eligibility Criteria:
Inclusion Criteria:

* Myocardial rest/regadenoson stress perfusion PET study within 60 days
* Normal rest LVEF (greater than or equal to 50%)
* No change in symptoms or treatment between the PET and the MRI study
* Willing to consent to the study
* Male or female who is either post-menopausal, surgically sterile, or if has a childbearing potential, a negative pregnancy test within 2 days prior to the MRI study.

Exclusion Criteria:

* Renal dysfunction (estimated glomerular filtration rate \< 60 mL/min/1.73m2) within 6 months
* Metallic implants, pacemaker, blood vessel clip (contra-indicated for MRI)
* Patient size exceeds MRI bore/table limits: (Max body diameter \> 60 cm, weight \> 136 kg)
* History of gadolinium contrast allergy or intolerance
* Second or third degree AV block
* Sinus node dysfunction
* Acute myocardial infarction (past 3 months)
* Actively wheezing or with acute asthma or bronchospastic attacks requiring changes in therapy within the past 30 days
* Patients that have experienced a previous hypersensitivity reaction thought to be related to regadenoson
Characterization and Causative Factors of Negative Dysphotopsia

The present study is designed as an exploratory study, seeking to investigate the correlation of patient complaints to subjective or objective measurement methods. Better understanding of causative factors of negative dysphotopsia will improve detection and maybe prediction of this optical phenomenon.


Eligibility Criteria:
Inclusion Criteria:

* Pseudophakic
* Recurrently and persistently reporting about negative dysphotopsia
* Age 21 and older
* written informed consent prior to entering the study

Exclusion Criteria:

* Relevant ophthalmic diseases such as: glaucoma, (previous) traumatic cataract, corneal scars, age-related macular degeneration and other pathologies resulting in visual field defects
* Pregnancy
Refining and Testing the Electronic Social Network Assessment Program (eSNAP)

The purpose of the study is to learn more about neuro-oncology caregivers' quality of life and how friends and families help neuro-oncology cancer caregivers at different times during treatment.

Former Aim 1: Refine eSNAP data-gathering and visualization prototypes based on evaluations of user experience, including usability, satisfaction and applicability. The refining process was completed at the University of Utah.

Aim 2: Test the feasibility of implementing eSNAP in a neuro-oncology clinical setting and collect preliminary effectiveness data of eSNAP on Family Caregiver outcomes, including quality of life and stress, and mediators (Family Caregiver social support utilization and burden). The feasibility process will take place at Moffitt Cancer Center.

This study will be a 2x2 longitudinal design. Caregivers of primary brain tumor patients will be compared to caregivers of patients with secondary brain tumors (brain metastases) to determine if there is something unique about the cancer-specific duties of primary versus secondary brain tumors that could impact the effectiveness of the eSNAP application. An intervention group will be compared to a control group for both types of caregivers. Participants will be randomized 2:1 for the intervention and control. All caregivers will be followed for 6 weeks and will be asked to complete questionnaires at 3 time points; caregivers in the intervention group will also be asked to use the eSNAP application at time 1, which will be available to them for the duration of the study.

Eligibility Criteria:
Inclusion Criteria:

* Family caregiver of a patient with primary or secondary brain tumor
* Age 18 years or older
* Able to speak and write English

Exclusion Criteria:

* Does not meet the Inclusion Criteria
OLE of Phase 2b/3 Study ANAVEX2-73-AD-004

This is a Phase 2b/3 open-label extension study to evaluate the effects of ANAVEX2-73 on safety and effficacy of daily treatment.

This is a Phase 2b/3 open-label extension study to evaluate the effects of ANAVEX2-73 on safety and effficacy of daily treatment.

Eligibility Criteria:
Inclusion Criteria:

* Previous completion of participation in the ANAVEX2-73-AD-004 double-blind study.
* Participants may be either outpatients, or residents of an assisted-living facility.
* Participants must have a designated study partner, who spends at least 10hrs per week with the participant, in order that assessments e.g. carer burden instruments are completed with true knowledge of the participant.
* No suicidal ideation of type 4 or 5 in the Columbia Suicide Severity Rating Scale (C-SSRS) in the past 3 months (i.e. active suicidal thought(s) with intent but without specific plan, or active suicidal thought(s) with plan and intent) OR suicidal behavior in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior).
* Confirmation from the participant that, if of childbearing potential is not pregnant through urine pregnancy testing.

Exclusion Criteria:

* Adverse events (AEs) from the previous study (ANAVEX2-73-AD-004) that have not resolved, are moderate or severe, judged to be possibly related or related to study drug, and considered by the investigator to be a contraindication to extension study participation
* Any condition or laboratory abnormality that would make the subject, in the judgment of the investigator, unsuitable for the study
* Significant history of drug addiction (with the exception of nicotine dependence) or abuse (including alcohol, as defined in DSM-V or in the opinion of the investigator) within the last two years prior to informed consent, or a positive urine drug screen for cocaine, opioid, phencyclidine (PCP), amphetamine or marijuana at screening. Prescription medication yielding a positive drug screen are acceptable except for tricyclic antidepressants (e.g. Amitriptyline, Amoxapine, Desipramine, (Norpramin) Doxepin, Imipramine (Tofranil), Nortriptyline (Pamelor), Protriptyline (Vivactil), Trimipramine (Surmontil)).
* Any known hypersensitivity to any of the excipients contained in the study drug formulation.
Effects of Dexmedetomidine on Stress Response and Postoperative Analgesia

Dexmedetomidine is a highly selective α2 adrenoreceptor agonist approved by the US FDA for short-term postoperative sedation and analgesia.It can also reduce the stress response without respiratory depression.

In this prospective, randomized, double-blind, placebo-controlled study，we gave dexmedetomidine or saline placebo 1h before operations were over and assessed the effects of dexmedetomidine on stress response and postoperative analgesia in patients undergoing thoracotomy during anesthesia recovery period.

Dexmedetomidine can significantly reduce the emergence agitation and postoperative pain in patients who received chest surgery

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anaesthesiologists Physical Status (ASA-PS) I or II
* undergoing selective thoracotomy
* weight between 45 and 75kg
* operation time 2-4 hours

Exclusion Criteria:

* history of neurologic disease
* history of chronic analgesics intake
* history of allergic reactions to the experimental durgs
* history of renal insufficiency
* history of hepatic dysfunction
* history of coagulation disorders
* women in lactation
* participating in other studies
Optimizing a Wellbeing Program for Care-partners of Those With SCI

Spinal cord injuries (SCI) have a devastating effect not only on individuals incurring the life changing event, but also on those who are involved in their care. Family care-partners of those with SCI (fcSCI) may experience significant negative effects including impaired mental health, high levels of burden, poor adjustment to role, decreased quality of life and strain on relationships. Cognitive behaviour therapy (CBT) is an evidence-based treatment strategy that helps individuals recognize and challenge their unhelpful thoughts and behaviours that contribute to their mental health concerns. However, barriers such as availability to specialized care, costs, rural and remote location, or concerns about stigma may limit access to care. Internet delivered CBT (ICBT) has the potential to reach a much wider group of people that may have unequal access to health care.

In a previous feasibility study, the team demonstrated the preliminary effectiveness of a tailored ICBT Wellbeing program for fcSCI. However, our understanding of which components of the program can result in optimal management is limited. The main purpose of this study is to evaluate the effectiveness of different components of the Wellbeing program including: therapist guidance, peer support groups, and booster sessions on symptoms of depression among fcSCI. The team will evaluate which intervention components result in meaningful improvement in symptoms of depression. Through collaborations with SCI community organizations and rehabilitation institutions, participants will be recruited across Canada. The researchers will also develop a model to examine the most cost-effective intervention package from the different components. The Wellbeing for fcSCI program can provide personalized service to individuals while being flexible and easily accessible, improving overall wellbeing and access to health care services.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Canadian residents
3. identify as fcSCI
4. living in the community
5. endorsing symptoms of depression (PHQ-9≥5);
6. suicide risk score \<8 (Suicide Behaviours Questionnaire (SBQ) (Osman et al. 2001)
7. speak and read English
8. able to access and be comfortable using computers and the internet
9. willing to provide the name of a physician as an emergency contact.

Exclusion Criteria:

1. are currently involved in another psychotherapeutic intervention
2. present with severe mental health disorder requiring face-to-face therapy (e.g., severe suicide ideation, severe substance abuse, recent history of psychosis, mania).

Those participants taking antidepressants will be included in the trial; medication use will be tracked.
Comparison of RCA and RACD in Extra-renal Purification by SLED

One of the main RRT issues is anticoagulation of the ECC, because blood contact with biomaterials causes bio-incompatibility reactions, including activation of the coagulation cascade. Based on Regional Citrate Anticoagulation (RCA) protocols, an ionized calcium (Ca-ion) concentration around 0.25 to 0.35mmol / L prevents fibrino formation and allows anticoagulation for the ECC. During RCA, metabolic side effects may occur due to systemic flow of citrate. Our postulate is that reduction of ionized calcemia related to the use of a calcium-free dialysate and haemofilter performance makes it possible to avoid citrate infusion. Our study aim to compare intermittent RRT using 4% Citrate infusion and without Citrate.

Background: Renal Replacement Therapy (RRT), requires anticoagulation of the extracorporal circuit (ECC) using heparin, citrate or repeated rinsing. Difficulties of implementation or exposition to complications (thrombosis, hemorrhage or electrolyte disorder) are frequent.

Purpose: Regional anticoagulation of the ECC based on ionized calcemia reduction, as using citrate, but induced by the use of a calcium-free dialysate associated with the performance of the hemofilter could reduce these risks and the cost of intermittent RRT. This study aims to compare the efficiency of a regional anticoagulation technique based on the reduction of Ionized Calcium in the extracorporal circuit, without the use of Citrate and with Citrate during intermittent RRT.

Abstract: One of the main RRT issue is anticoagulation of the ECC, because blood contact with biomaterials causes bio-incompatibility reactions, including activation of the coagulation cascade. Based on Regional Citrate anticoagulation (RCA) protocols, an ionized calcium (Ca-ion) concentration around 0.25 to 0.35mmol/L prevents fibrino formation and allows anticoagulation for the ECC. During RCA, metabolic side effects may occur due to systemic passage of citrate. Our postulate is that reduction of ionized calcemia related to the use of a calcium-free dialysate and haemofilter performance makes it possible to avoid citrate infusion. Our study aims at comparing intermittent RRT using 4% Citrate infusion and without Citrate.

Eligibility Criteria:
Inclusion Criteria:

* All patient requiring Renal replacement Therapy

Exclusion Criteria:

* Age \< 18 years
* Pregnancy
* Hypercalcemia ≥ 3 mmol/L.
* Major under guardianship
* Major deprived of freedom
* Impossible to obtain free and informed consent
* Presence of hemostasis or coagulation disorders:
* Thrombocytopenia \< 30 G/L.
* Curative anticoagulation.
* Severe liver disease with Prothrombin rate \<30%.
* Coagulation factor deficit.
* Not registered to a social security system.
An OCT-Guided Variable Dosing Regimen With Ranibizumab for the Treatment of Neovascular AMD

This study was designed to evaluate a variable dosing regimen with intravitreal ranibizumab for the treatment of patients with neovascular age-related macular degeneration (AMD) in the Prospective OCT Imaging of Patients with Neovascular AMD Treated with Intra-Ocular Ranibizumab (PrONTO) study.

In this 2-year open-label, prospective, single-center, uncontrolled, investigator sponsored clinical study, neovascular AMD patients with subfoveal CNV (N=40) and a central retinal thickness of at least 300 µm as measured by optical coherence tomography (OCT) were enrolled to receive 3 consecutive monthly intravitreal injections of ranibizumab (0.5 mg). Thereafter, retreatment with ranibizumab was performed if one of the following changes were observed between visits: a loss of 5 letters in conjunction with fluid in the macula as detected by OCT, an increase in OCT central retinal thickness of at least 100 μm, new onset classic CNV, new macular hemorrhage, or persistent macular fluid following an injection of ranibizumab at the prior study visit.

Eligibility Criteria:
Inclusion Criteria:

* Age 50 years or older
* Active primary or recurrent macular neovascularization secondary to age-related macular degeneration (AMD) involving the central fovea in the study eye with evidence of disease progression
* OCT central retinal thickness ≥ 300 microns
* Best corrected visual acuity, using ETDRS charts, of 20/40 to 20/400 (Snellen equivalent) in the study eye

Exclusion Criteria:

* More than 3 prior treatments with verteporfin photodynamic therapy
* Previous participation in a clinical trial (for either eye) involving antiangiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors)
* Previous subfoveal focal laser photocoagulation in the study eye
* Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding day 0
* Subfoveal fibrosis or atrophy in the study eye
* History of vitrectomy surgery in the study eye
* Aphakia or absence of the posterior capsule in the study eye
* History of idiopathic or autoimmune-associated uveitis in either eye
A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201)

The purpose of this study is to evaluate the overall response rate (ORR) of pemigatinib as a monotherapy in the treatment of metastatic or surgically unresectable urothelial carcinoma harboring FGF/FGFR alterations.


Eligibility Criteria:
Inclusion Criteria:

* 20 years and older in Japan
* Histologically documented metastatic or surgically unresectable urothelial carcinoma; may include primary site from urethra, ureters, upper tract, renal pelvis, and bladder.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* Life expectancy ≥ 12 weeks.
* Radiographically measurable per RECIST v1.1.
* Documented FGF/FGFR alteration and have either 1a) failed at least 1 previous treatment for their metastatic or surgically unresectable urothelial carcinoma (ie, chemotherapy, immunotherapy) or 1b) have not received chemotherapy due to poor ECOG status or 2) have insufficient renal function.

Exclusion Criteria:

* Prior receipt of a selective FGFR inhibitor.
* Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug.
* Inability or unwillingness to swallow pemigatinib or significant gastrointestinal disorder(s) that could interfere with the absorption, metabolism, or excretion of pemigatinib.
A Pharmacovigilance Study of Torsade de Pointes

Many cardiac and non-cardiac drugs are associated with TdP that may constitute a significant problem because of sudden cardiac death. This study aims to present a comprehensive overview and disproportionality analysis of TdP cases reported to the Food and Drug Administration Adverse Event Reporting System (FAERS) in order to identify new signals of TdP.

Drug-induced Torsade de Pointes (TdP) is a serious but an overlooked adverse drug reaction because a wide range of marketed drugs associated with TdP are commonly prescribed in routine practice. Owing to the heightened concern of a vast number of drug-TdP associations including newly approved drugs, the investigators, therefore, aims to investigate drug-TdP associations by performing disproportionality analysis in order to identify new signals of TdP utilizing the individual case reports of TdP in the FAERS database.

Eligibility Criteria:
Inclusion Criteria:

* TdP cases reported in the FAERS database till 31/03/2019
* Adverse event reported was including the MedDRA term: Torsade de Pointes

Exclusion Criteria:

* Drugs with less than 10 TdP reports
BAY81-8781, I.V. Aspirin in the Indication of Acute Coronary Syndrome (ACS)

The objective of this study is to investigate whether intravenous administration (injected into a vein) of acetylsalicylic acid (Aspirin) in doses of 250 and 500 mg is superior to oral treatment of ACS with tablets containing 300 mg of Aspirin.

In November 2009 it was the company's decision to cancel this study as an international trial. However, to support the local MA application of Aspirin i.v. for the indication "For the initial treatment in case of suspicion of acute coronary syndrome", Bayer decided to perform this trial in Germany as a domestic trial, with changed number of participants and study dates.

Eligibility Criteria:
Inclusion Criteria:

* Angina pectoris lasting for more than 20 minutes within the last 24 hours before study drug treatment (or equivalent acute symptoms such as increasing dyspnea, diaphoresis, nausea, abdominal/epigastric pain, syncope etc.)
* ECG change suggestive for ischemia:
* ST elevation or T-wave change or ST depression, new or presumed left bundle-branch block (LBBB)
* Elevated troponin T level \> 0.01 ng/ml, levels according to local laboratory reference values
* Risk factors for ACS such as known coronary artery disease (CAD), diabetes mellitus, impaired renal function, peripheral artery or cerebrovascular disease, current smoking.

Exclusion Criteria:

* Treatment with acetylsalicylic acid (ASA) within 48 hours prior to study drug treatment
* Treatment with glycoprotein IIa/IIIb inhibitors within 48 hours prior to study drug treatment and before the 20 minutes blood samples for thromboxane, prostacycline and platelet aggregation measurement have been taken
* Thrombolytic therapy within 24 hours before study drug treatment
* Obligation for tracheal intubation and mechanical ventilation
* Contraindications to ASA treatment
* Known haemorrhagic diathesis
* Evidence of an active gastrointestinal or urogenital bleeding
* Stroke within 3 months prior to study drug treatment
* Major surgery including coronary artery bypass graft (CABG) within 6 weeks prior to study drug treatment
* Known severe hepatic or renal insufficiency
* Pregnant or breast-feeding women