cyrilzakka/clinical-trials huggingface dataset:
Vessel Imaging Using Optical Coherence Tomography for Plaque Morphology and Vessel Fractional Flow Reserve

The aim of this prospective, investigator-initiated study is to evaluate the diagnostic accuracy and correlations between mopphometric indices: luminal and qualitative parameters assessed by optical coherence tomography (OCT) including minimal lumen area, plaque type, presence of thin cap fibroatheroma and a functional index - angiography based vessel fractional flow reserve (vFFR) among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis.

This is a prospective, single center, non-randomized, single-arm, investigator-initiated study evaluating diagnostic accuracy and correlations between morphometric indices: luminal and qualitative parameters evaluated by optical coherence tomography (OCT) including minimal lumen area, plaque stratification into fibrotic, calcific, lipidic plaque, or thin cap fibroatheroma and a functional index - angiography based vessel fractional flow reserve (vFFR) among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis.

The additional objectives encompass assessing the influence of age, sex, diabetes mellitus, renal dysfunction on the relationship between vFFR results and morphometric indices of intermediate coronary stenosis.

We hypothesized that in patients with intermediate grade coronary stenosis in chronic coronary syndrome a positive correlation exists between vFFR and the morphometric parameters associated with coronary stenosis.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Chronic coronary syndrome defined as presence of chest pain ranked 2-3 in the Canadian Cardiovascular Society classification or positive ischemia test (exercise test, single photon emission tomography (SPECT)
* Intermediate grade coronary stenosis of 40-80% assessed visually in coronary angiography and OCT examination The patient is willing to participate in the study and has provided a written informed consent

Exclusion Criteria:

* Acute coronary syndrome
* Proximal left main lesion
* Ostial right coronary artery lesion
* Bypass of the assessed vessel
* Contraindications for adenosine administration
* Hemodynamic instability
* Heart insufficiency in New York Heart Association (NYHA) class IV scale
* Acute renal insufficiency
* Pregnancy
Clozapine and Haematologic Malignancies: Observational and Retrospective Study Using the WHO Pharmacovigilance Database

Clozapine may lead to various adverse reactions, including neutropenia and agranulocytosis. This study investigates reports of lymphoma and leukaemias for clozapine in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).

Clozapine is responsible of a wide range of adverse side effects.The investigators use VigiBase, the World Health Organization (WHO) database of individual safety case reports, to identify cases of haematologic malignancies following treatment with clozapine.

Eligibility Criteria:
Inclusion Criteria:

* Case reported in the World Health Organization (WHO) database of individual safety case reports to 03/05/2019
* Adverse events reported were including the MedDRA terms: Malignant Lymphoma (SMQ), Leukaemia (HLGT)
* Patients treated with at least one liable antipsychotic drug (ATC class N05A)

Exclusion Criteria:

* Chronology not compatible between the drug and the toxicity
Ozurdex Implant for Macular Edema After Treatment Failure With Anti-VEGF

To determine if Ozurdex implant can offer an effective treatment for macular edema associated with retinal vein occlusion when treatment with intravitreal Avastin, Lucentis, or Eylea have not demonstrated a significant response.

To determine whether Ozurdex implant can offer an efficacious alternative for treatment of macular edema in the setting of retinal vein occlusion when treatment with intravitreal bevacizumab (Avastin),ranibizumab (Lucentis), and/or aflibercept (Eylea) have not demonstrated significant response.

Eligibility Criteria:
Inclusion Criteria:

All patients with Retinal Vein Occlusion (RVO) with available initial imaging and documented treatment failure with bevacizumab, ranibizumab, or aflibercept. Treatment failure is defined as lack of anatomic improvement (persistent intraretinal cystic changes/macular edema with central subfield thickness greater than 250 microns on time-domain OCT or greater than 275 microns on spectral domain OCT) with lack of visual improvement (less than 2 lines of visual gain by Snellen acuity), despite 3 to 6 intravitreal anti-VEGF treatments over the preceding 6 months.

Exclusion Criteria:

* Co-existing or pre-existing macular degeneration, diabetic macular edema, or other confounding disease processes
* Interval surgical intervention, such as cataract surgery, that may confound visual outcomes.
* Pregnancy
* Coexisting conditions that would represent relative or absolute contraindications usage of ozurdex implant, including:
* Ocular or periocular infections (including viral disease of the cornea and conjunctiva such as active epithelial herpes simplex keratitis, vaccinia, varicella, mycobacterial infection, and fungal diseases)
* Advanced glaucoma
* Aphakic eyes with rupture or missing posterior lens capsule
* Eyes with anterior chamber intraocular lens and missing posterior lens capsule
* Patients with known hypersensitivity to components of this product
Extracorporeal Shock Wave Versus Local Corticosteroid Injection for Carpal Tunnel Syndrome

This RCT is to investigate the clinical effect of extracorporeal shock wave therapy (ESWT) compared to the local corticosteroid injection (LCI) in managing mild to moderate carpal tunnel syndrome (CTS).

To investigate the effect of extracorporeal shock wave therapy (ESWT) compared to the local corticosteroid injection (LCI) in managing mild to moderate carpal tunnel syndrome (CTS). About 50-60 patients with mild to moderate CTS are supposed to be randomly allocated into either ESWT group or LCI group. The outcomes include the visual analog scale (VAS), the Boston Carpal Tunnel Questionnaire (BCTQ), and nerve conduction study at baseline and at 3 weeks, 9 weeks, 12 weeks, 6 months, and 12 months after the treatments.

Eligibility Criteria:
Inclusion Criteria:

The patients aged ≥18 years

1. Should present a new episode of CTS with symptoms lasting for ≥ six weeks
2. Symptoms include wrist pain, numbness, and paraesthesia on the hands
3. Tested postive by the Phalen test and Tinel test
4. Electrodiagnostically diagnosed with mild to moderate CTS

Exclusion Criteria:

1. A lack of consent information
2. A history of a CTS surgery or LCI in the carpal tunnel
3. Asystemic disease that may interfere with the study
Periotome Versus Peizotome as an Aid of Atraumatic Extraction.

This study aims to compare between periotome and piezotome in terms of efficiency and durability in procedures of simple extractions as an alternative atraumatic extraction technique.

Teeth extraction is one of the commonly preformed procedures in the dental clinics, and one of the most important precautions followed during the different techniques of teeth extraction is tissue preservation and the avoidance of tissue trauma. So, for the preservation of bone and tissues integrity and elimination of post operative pain and discomfort, atraumatic extraction techniques are presented.

A claim has risen that due to its thin tips which is inserted vertically to the PDL avoiding the leveraging forces caused by conventional elevators, Periotome will aid in the reduction of soft tissue injury and the preservation of bone integrity. While Piezotome which is a newer and innovative device using ultrasonic vibrations mainly for the purpose of osteotomy is considered very efficient due to its selective cutting and being inert against soft tissues, including nerves and blood vessels. leading to lesser cell necrosis and faster bone regeneration providing a minimally invasive atraumatic extraction technique.

And with the rapid development of implantology and painless dentistry, the demands on more efficient, minimally invasive and more durable atraumatic extraction techniques has increased.

This study aims to compare between periotome and piezotome in terms of efficiency and durability in procedures of simple extractions as an alternative atraumatic extraction technique.

Eligibility Criteria:
Inclusion Criteria:

* Grade I or II patients according to ASA
* Teeth indicated for simple extraction
* Teeth indicated for extraction and immediate implant placement
* Teeth of grade 0-I Mobility
* Remaining roots with sound form

Exclusion Criteria:

* Grade III-VI patients according to ASA
* Mobility Grade ≥ II
* Teeth indicated for surgical extraction

  * ASA: American Society of Anesthesiologists Physical Status Classification System 2020
Method of Exit Site Care in Chronic Peritoneal Dialysis Patients

Peritoneal dialysis accounts for more than 70% of the dialysis modality in Hong Kong. Exit site infection (ESI) is one of the causes leading to peritoneal catheter removal. Appropriate exit-site care can prevent ESI. As the presence of a causative organism is essential in ESI, eliminating organism invasion may be useful in preventing ESI. In the present study, an exit site care method aiming at preventing organism invasion is developed to investigate its effectiveness in reducing ESI. It is also hoped the present study can help to develop an exit site care method that can reduce the frequency of exit site dressing so as to reduce the burden of patients and to improve their quality of life.

We'll recruit one hundred new chronic peritoneal dialysis patients into the study. The patients will be divided into two groups. One group of the patients will use film-dressing method (F) and the other group will use simple gauze dressing method (G). F group patients will have the exit site covered with a dressing film and keep it intact for 7 days after having the exit site cleaned with antiseptic solution. G group patients will clean the exit site with antiseptic solution and change the simple gauze dressing daily.

The outcomes of the two groups will be compared. The outcome will be expressed in terms of exit site infection free period, peritonitis free period and exit site condition classification. Patient subjective quality of life will also be compared at first and twelfth month.


Eligibility Criteria:
Inclusion Criteria:

* chronic renal failure patients with peritoneal catheter newly inserted

Exclusion Criteria:

* Patients have exit-site infection before stitches removal or presence of signs and symptoms of exit-site infection at the time of remove stitches.
* Patients plan to move out of PWH or transplant soon after catheter insertion.
* Patients have known history of allergy to adhesives / tapes.
* Extremely non-compliant patients.
Enhanced FoCUS in Patients With Shortness of Breath

Retrospective observational study performed in a internal medicine ward of a French university hospital. Included patients were hospitalized for acute shortness of breath who have benefited from a eFOCUS which was defined as a focused cardiac Ultrasound with utilization of Doppler measurements.

The objectives were the therapeutic and diagnosis changes induced by eFoCUS. The primary endpoint was defined by the pooled introduction or discontinuation of diuretics, antibiotics or anticoagulants associated with eFoCUS results.

It was a retrospective observational study performed in a internal medicine ward of a French University Hospital. Patients were identified in the hospital database, pertinent features and eFoCUS findings were extracted and anonymized.

Inclusion criteria:

* Adult patients admitted to an internal medicine ward from the ED for acute shortness of breath.
* Realization of an eFoCUS prescribed by the physician in charge of the patient

Exclusion criteria:

• Comprehensive echocardiography already performed Methods For each identified patient, pertinent data (demography, initial diagnosis and treatment (diuretics, antibiotics, anticoagulants)) and eFoCUS findings were extracted from the hospital files, anonymized and entered in a LibreOffice spreadsheet. Extracted diagnosis were gathered into the following categories: Community-acquired pneumonia (CAP), Acute cardiogenic pulmonary edema (ACPE), Pulmonary embolism (PE), Chronic Obstructive Pulmonary Disease (COPD) and other (OTHER).

Objectives and endpoints

* The main objective was the therapeutic change induced by eFoCUS. The primary endpoint was defined by the pooled introduction or discontinuation of diuretics, antibiotics or anticoagulants associated with eFoCUS results.
* The secondary objectives were diagnosis modifications induced by eFoCUS. Data analysis
* Numerical data were presented as mean ± SD or as median with interquartile range depending on the normality. The paired Student's t-test was used to compare normally distributed data. The chi-square test was used for the comparison of noncontinuous variables expressed as proportions. A p-value \<0.05 was considered significant. All p-values were two-sided. Statistical analysis was realized with R (4.03.3) in the Rstudio® environment.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients admitted to a internal medicine ward from the ED for acute shortness of breath.
* Realization of an eFoCUS prescribed by the physician in charge of the patient

Exclusion Criteria:

* Comprehensive echocardiography already performed
Safety and Efficacy of NMD670 in Adult Patients with Type 1 and Type 2 Charcot-Marie-Tooth Disease

This Phase 2a study aims to evaluate the efficacy, safety and tolerability of NMD670 vs placebo administered twice a day (BID) for 21 days in ambulatory adult patients with Charcot-Marie-Tooth disease type 1 and type.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants must be 18 to 70 years inclusive at the time of signing the ICF.
* Diagnosis of CMT type 1 or 2 confirmed by genetic testing.
* Body mass index between 18 and 35 kg/m2, inclusive, at screening, and with a minimum weight of 40 kg
* Contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
* Participant is capable of and has given signed informed consent

Exclusion Criteria:

* Participants with other significant disease that may interfere with the interpretation of study data (e.g., other neuromuscular diseases) and/or ability to complete the tests, in the opinion of the Investigator.
* Participants with laboratory test result abnormalities at screening considered clinically significant by the Investigator.
* Participants who have received treatment with another IMP within 30 days (or 5 half-lives of the medication, whichever is longer) prior to day 1.
* Participants with history of poor compliance with relevant therapy in the opinion of the Investigator.
* Female participants who plan to become pregnant during the study or are currently pregnant or breastfeeding.
A Study of Barzolvolimab in Patients With Atopic Dermatitis

The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with Atopic Dermatitis

This is a multicenter, randomized, double-blind, parallel group, placebo controlled phase 2 study to assess the efficacy and safety of barzolvolimab (CDX-0159) in adult participants with Atopic Dermatitis.

There is a screening period of up to 28 days, a 16-week double-blind, placebo-controlled treatment period, a 16-week double-blind, active treatment period, and a 16-week follow-up period. On Day 1, participants will be randomly assigned on a 1:1:1 ratio to receive barzolvolimab (CDX-0159) by subcutaneous injections of 150 mg every 4 weeks (Q4W) after an initial loading dose of 450 mg \[Arm 1\], 300 mg Q4W after an initial loading dose of 450 mg \[Arm 2\], or placebo Q4W \[Arm 3\]. At Week 16, participants on placebo will be re-randomized on a 1:1 ratio to receive barzolvolimab by subcutaneous injections of 150 mg every 4 weeks (Q4W) after an initial loading dose of 450 mg, 300 mg Q4W after an initial loading dose of 450 mg. Participants on Arms 1 and 2 will undergo a mock re-randomization at Week 16 to maintain the blind.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 18 years of age
2. Diagnosis of chronic atopic dermatitis (AD) for at least 1 year
3. Onset of symptoms at least 1 year prior and current symptoms consistent with moderate to severe AD as defined by:

   1. EASI ≥ 12 at Visit 1 and EASI ≥ 16 at Visit 2
   2. Body Surface Area of Involvement (BSA) ≥ 10% at Visit 1 and Visit 2
   3. IGA score ≥ 3 at Visit 1 and Visit 2
   4. Severe itch, defined by weekly average of daily PP-NRS score of ≥ 5, during the 7 days prior to treatment
4. Documented history of inadequate response to treatment with topical medications or for whom topical medications are otherwise medically inadvisable.
5. Willing and able to complete a daily symptom electronic diary for the duration of the study and adhere to the study visit schedule.

Exclusion Criteria:

1. Any other active pruritic skin diseases that would confound AD assessments based on the Investigator's clinical judgment.
2. Phototherapy with ultraviolet (UV) A or UVB within 4 weeks of Visit 1.
3. Planned or anticipated use of any prohibited medications at any time during the study.
4. Prior receipt of barzolvolimab or other anti-KIT therapy. There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
Sequential Versus Single O2 Levels on Human Embryo Development

Myriads of elements affect human embryo culture in vitro. These include, but not limited to, air quality, culture media, culture temperature, incubator humidity, pH, and O2 levels. O2 tension has been thoroughly investigated and, to date, 5% O2 level is superior to 20%. Reports showed that lowering the O2 from Day 3 of embryo culture seems to be physiological.


Eligibility Criteria:
Inclusion Criteria:

* ICSI cycles undergoing their first ICSI attempt

Exclusion Criteria:

* ICSI cycles with a previous failure
Combined Colloid Preload And Crystalloid Coload Versus Crystalloid Coload During Spinal Anesthesia for Cesarean Delivery

The study will compare one technique of fluid administration (combined colloid preload and crystalloid colaod) with another one (crystalloid coload) during elective cesarean delivery performed under spinal anesthesia.

This randomized, controlled, double-blind study will be conducted on ASA physical status II parturients with full-term singleton pregnancy undergoing elective cesarean delivery under spinal anesthesia. Participants will receive either 500 mL colloid preload and 500 mL crystalloid coload (Combination group) or 1000 mL crystalloid coload (Coload group). Systolic blood pressure will be recorded every minute and ephedrine will be administered when hypotension occurs according to a predefined protocol. The total ephedrine dose, time to the first ephedrine dose, heart rate, inferior vena cava diameter, nausea/vomiting, and neonatal Apgar scores will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status II parturients
* Full term, singleton pregnancy
* Elective cesarean delivery under spinal anesthesia

Exclusion Criteria:

* Age \<19 or \> 40 years
* Height \<150 cm
* Weight \<60 kg
* Body mass index ≥40 kg/m2
* Contraindications to spinal anesthesia (increased intracranial pressure, coagulopathy, or local skin infection)
* Chronic or pregnancy-induced hypertension
* Hemoglobin \<10 gm/dL.
* Diabetes mellitus, cardiovascular, cerebrovascular, or renal disease
* Polyhydramnios or known fetal abnormalities
A Phase I Study to Evaluate the Safety, Reactogenicity, and Humoral Immune Responses to an Inactivated H5N1 Influenza Vaccine

The focus of this study is to evaluate the safety, reactogenicity and humoral immune responses of the study vaccine when administered at the dose of 7.5 µg HA, 15 µg HA, or 30 µg HA to human subjects.

Since 1997, avian H5N1 influenza in Southeast Asia has caused several human infections and has a high mortality rate. Experts warn that the next influenza pandemic is imminent and could be severe and prevention and control will depend on the rapid production and worldwide distribution of specific pandemic influenza candidate vaccines. An H5N1 influenza vaccine was successfully produced from whole virus grown in MDCK (Madin-Darby canine kidney) cells. These purified inactivated vaccine antigens were safe and could induce immune responses in animal studies. Moreover, when formulated in aluminum phosphate a stronger response was generated even at low doses in animals (Chong et al., 2008; Hu et al., 2008). However, further investigations are necessary before their human safety and immunogenicity can be established. This human phase I clinical study, therefore, evaluates the safety and immunogenicity of adjuvanted H5N1 virion influenza vaccine.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥20 and ≤60 years of age
* In good health as determined by medical history, physical examination, and clinical judgment of the investigator
* Willing and able to comply with all required study visits and follow-up required by this protocol
* Must provide written informed consent

Exclusion Criteria:

* Known or potential exposure to avian influenza virus or any H5N1 HA antigen vaccine
* Had any influenza vaccine within 6 months
* Administered with any vaccine within 30 days
* A history of hypersensitivity to vaccines or inflammatory or degenerative neurological disease
* Receiving chronic administration of immunosuppressants or other immune-modifying drugs within 6 months
* Known HIV, hepatitis B (HBsAg) or hepatitis C seropositivity
* Any medical illness including clinically significant acute pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests
* Receiving immunoglobulins and/or any blood products within the three months
* Acute disease at the time of enrolment
* Psychiatric, addictive, or any disorder, which may compromise the ability to give a truly informed consent for participation of this study or adequate compliance
* Breast feeding or pregnant women
Dual-Energy CT on Plan Quality, Dose-delivery Accuracy, and Simulated Outcomes of Patients Treated With Proton or Photon Therapy

The aim of this protocol is to refine the accuracy of proton beam therapy (PT) by the use of dual energy computed tomography (DECT), in conjunction with novel iterative image reconstruction algorithms, to more precisely determine the tissue properties through which the proton beam path travels.


Eligibility Criteria:
Eligibility Criteria:

Inclusion Criteria:

* Diagnosis of histologically proven primary or metastatic cancer requiring thoracic radiation therapy OR radiation therapy to the head and neck or brain
* At least 18 years of age.
* Planning to undergo proton or photon beam radiation therapy as part of the clinical management of the diagnosed cancer.
* Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

* Implanted metallic objects in the region to be scanned excepting dental prostheses
* IV or oral contrast medium within 24 hours prior to DECT image acqusition
* Pregnant.