cyrilzakka/clinical-trials huggingface dataset:
Monitoring of Non-Surgical Treatment of Peri-implantitis

This study aimed to investigate the response to non-surgical treatment of peri-implantitis diseases during the maintenance phase. The patients underwent non-surgical implant maintenance treatment, and the success of the treatment was measured again after 30 days using the same criteria and methods.

For 40 patients, the aMMP-8 test was performed on the buccal gingival pocket of the implant teeth, gingival bleeding (BOP), implant pocket depth (PPD), and a periapical x-ray to measure radiologic bone level (RBL) were taken.

Eligibility Criteria:
Inclusion Criteria:

* implant patients arriving for a maintenance visit at a dental clinic
* a diagnosis of peri-implant healthy, peri-implant mucositis, or peri-implantitis by a dentist
* a written informed consent.

Exclusion Criteria

* Smoking
* age under 25
* antibiotic treatment within six months
* the maintenance treatment had been completed within 6 months.
A Deep Learning Method to Evaluate QT on Ribociclib

"Deep-learning" is a fast-growing method of machine learning (artificial intelligence, AI) which is arousing the interest of the scientific committee in many medical fields. These methods make it possible to generate matches between raw inputs (such as the digital signal from the ECG) and the desired outputs (for example, the measurement of QTc). Unlike traditional machine learning methods, which require manual extraction of structured and predefined data from raw input, deep-learning methods learn these functionalities directly from raw data, without pre-defined guidelines. With the advent of big-data and the recent exponential increase in computing power, these methods can produce models with exceptional performance. The investigators recently used this type of method using multi-layered artificial neural networks, to create an application based on a model that directly transforms the raw digital data of ECGs (.xml) into a measure of QTc comparable to those respecting the highest standards concerning reproducibility.

The main purpose of this trial is to study the performance of our DL-AI model for QTc measurement (vs. best standards of QTc measurements, TCM) applied to the recommended ECG monitoring following ribociclib prescription for breast cancer patients in routine clinical care. The investigators will acquire ECG with diverse devices including simplified devices (one/three lead acquisition, low frequency sampling rate: 125-500 Htz) to determine if they'll be equally performant versus 12-lead acquisition machine to evaluate QTc in this setting.


Eligibility Criteria:
Inclusion Criteria:

* Adult female patients requiring start of ribociclib based therapy for a breast cancer in their standard of care, as per their summary of product characteristic's indications
* Association with hormone-based therapy in combination is authorized (aromatase inhibitors or fulvestrant)
* Able to provide an informed consent

Exclusion Criteria:

* Any allergy or contra-indication to ribociclib as mentioned in their as summary of product characteristic's
* Patients presenting a condition precluding accurate QTc measurements on electrocardiogram, i.e paced ventricular rhythm, multiples premature ventricular or supra-ventricular contractions, ventricular tachycardia, supraventricular arrhythmia (including atrial fibrillation, flutter or junctional rhythm)
* Patients with an atrial pacing and sinus dysfunction
* Patients presenting a contra-indication for ECG measurement, or with a device rendering ECG measurements impossible (i.e. Diaphragmatic pacing)
* Patients presenting a contra-indication to ribociclib start; including association with prohibited drug potentializing the risk of TdP
Validation Study of Combined Positron Emission Tomography/Computer Tomography to Diagnose Infection and Inflammation

The overall aim is to validate the current use of FDG PET/CT for the diagnosis of infection and inflammation and examine the usefulness of PET/CT applying also other tracers.

The results should allow us to confirm our primary hypothesis: "FDG-PET/CT is better than established methods to confirm or exclude the diagnosis of infection/inflammation".

The study include several part projects, each contributing to the evaluation of the value of FDG-PET/CT in the diagnosis of infection and inflammation. The aims are to establish the diagnostic value in terms of sensitivity, specificity, positive and negative predictive values, interobserver and intraobserver variation.

Part project A FDG-PET/CT in patients with blood culture positive for staphylococcus aureus and unresolved origin of infection.

Part project B FDG-PET/CT in patients with fever of unknown origin.

Part project C FDG-PET/CT in patients suspected of vascular graft infection.

Additionally, we wish to establish an optimal imaging protocol (necessity of fasting, consequences of antibiotic therapy prior to imaging, and the need of contrast), interpretation criteria, and the value of standard uptake values (SUV).

Eligibility Criteria:
Inclusion Criteria:

Part project A

• Blood culture positive for staphylococcus aureus and unresolved origin of infection.

Part project B

* Fever of unknown origin
* Referred for FDG-PET/CT at the Department of Nuclear Medicine, Odense University Hospital.

Part project C

* Suspected vascular graft infection
* Referred for FDG-PET/CT at the Department of Nuclear Medicine, Odense University Hospital.

Exclusion Criteria:

* Patients incapable of giving, refusing or revoking consent
* Patients less than 18 years of age
* Patients from other regions than the Region of Southern Denmark
* Patients who cannot cooperate to PET/CT scan.
A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma

The purpose of this study is to characterize the safety and tolerability of talquetamab when administered in different combination regimens and to identify the safe dose(s) of talquetamab combination regimens.


Eligibility Criteria:
Inclusion Criteria:

* Have documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
* Have measurable disease at screening as defined by at least 1 of the following: a. Serum monoclonal protein (M-protein) level greater than or equal to (\>=) 1.0 gram per deciliter (g/dL); or b. Urine M-protein level \>= 200 milligrams (mg)/24 hours; or c. Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) \>=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
* Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at screening and immediately before the start of study treatment administration
* A woman of childbearing potential must have a negative highly sensitive serum beta human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours before the start of study treatment administration
* Be willing and able to adhere to the lifestyle restrictions specified in the protocol, including adherence to the applicable immunomodulatory drug (IMiD) global Pregnancy Prevention Plan (PPP) or local PPP/Risk Evaluation and Mitigation Strategy (REMS) program

Exclusion Criteria:

* Live, attenuated vaccine within 4 weeks before the first dose of study treatment
* Received a cumulative dose of corticosteroids equivalent to \>=140 mg of prednisone within the 14-day period before the start of study treatment administration
* Active central nervous system (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
* Known to be seropositive for human immunodeficiency virus
* History of stroke or seizure within 6 months prior to the first dose of study treatment
Tailored Therapy for Helicobacter Pylori in Children

This study is designed to compare the eradication rates，safety and compliance of tailored therapy to those of standard triple therapy in children with H. pylori infection. The primary purpose is to compare the eradication rates of children with H. pylori infection treated with tailored therapy to those treated with standard triple therapy. The secondary purpose is to evaluate the safety, compliance and factors that might affect eradication rates.

Between March 2014 and March 2016, 200 children with upper gastrointestinal symptoms (4-18 years) and H. pylori infection will be recruited at Beijing Children Hospital.After the informed consents are obtained from the guardians, the children will be randomly classified into the two group: 10 days standard triple therapy (Omeprazole 0.8-1.0mg/kg.d,bid, Amoxicillin 30-50mg/kg.d bid， Clarithromycin 15-20mg/kg.d bid), or 10 days tailored therapy including one Proton Pump Inhibitor ( Rabeprazole 0.4-0.5mg/kg.d,bid. or Esomeprazole 0.8-1.0mg/kg.d,bid) and two antibiotics (Amoxicillin 30-50mg/kg.d bid, Clarithromycin 15-20mg/kg.d bid, Metronidazole15-20mg/kg.d bid) based on antibiotics susceptibility and cytochrome P450 isoenzyme 2C19 genotype. Eradication status will be reassessed in four weeks after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of H. pylori infection.
* Presence of upper gastrointestinal symptoms.
* Referred for upper endoscopy at Beijing Children's Hospital

Exclusion Criteria:

* Presence of endoscopy contraindications
* The administration of any drug that could influence the study results including proton pump inhibitors, H2-receptor blockers, bismuth salts and antibiotics within the previous four weeks;
* Gastrointestinal malignancy;
* Previous gastric or esophageal surgery;
* Severe concomitant diseases
* History of allergy to any of the study drugs;
Assessment of the Effectiveness and Tolerability of Ovarian Hyperstimulation

The aim of the study is to assess the effectiveness of 5 mixed protocols of ovarian hyperstimulation with urinary gonadotrophins to achieve clinical pregnancy in females undergoing assisted reproductive techniques (IVF/ICSI) (in-vitro fertilisation/intracytoplasmic sperm injection).

Study hypothesis: mixed protocols with urinary FSH (follicle-stimulating hormone) and urinary hMG (human menopausal gonadotropin)should be more effective than monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18 and 30
* Prolactin within the laboratory normal range
* Couples affected by sterility able to treat by IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection)
* Patients undergoing Menopur® and/or Bravelle® treatment
* Normal thyroid function
* Women not receiving clomifen citrate or gonadotrophins within one month prior study start
* Couples willing to participate in the study that have signed the informed consent form

Exclusion Criteria:

* Failure in 3 previous cycles of assisted reproduction IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection)
* Policystic ovarian syndrome
* Seminal samples not apt for IVF-ICSI (according to the criteria of each center)
* Evidence of significant bacterial infection in the seminogram of the couple in the preceding 6 months
* Antecedents of severe ovarian hyperstimulation syndrome (OHSS)
* Important systemic disease
* Pregnancy or contraindication to pregnancy
Study to Evaluate the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for Coronavirus Disease 2019 (COVID-19)

The primary objective of this study is to evaluate whether remdesivir (RDV, GS-5734™) reduces the composite risk of death or invasive mechanical ventilation (IMV) through Day 29 in participants with severely reduced kidney function who are hospitalized for coronavirus disease 2019 (COVID-19).


Eligibility Criteria:
Key Inclusion Criteria:

* Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) positive as determined by Polymerase Chain Reaction (PCR) or other commercially available or public health assay (eg, Nucleic Acid Amplification Test (NAAT) and antigen tests) in any respiratory specimen
* Hospitalized for COVID-19
* Weighing at least 40 kilograms (kg)
* Oxygen (O2) saturation ≤ 94% on room air or requiring O2 supplement or Radiographic evidence of pulmonary infiltrates for COVID-19
* Have either:

  * a) Severely reduced kidney function (estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min/1.73 m\^2), including people with end-stage kidney disease (ESKD) requiring chronic dialysis
  * b) Ongoing acute kidney injury (AKI): defined as a 50% increase in serum creatinine (SCr) within a 48-hour period that is sustained (ie, requires confirmatory SCr) for ≥ 6 hours despite supportive care
* The interval between COVID-19 symptoms onset and randomization is no more than 10 days

Key Exclusion Criteria:

* Received any investigational drug, RDV, or other antiviral treatment for COVID-19
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 times the upper limit of normal
* Invasive mechanical ventilation, noninvasive mechanical ventilation, extracorporeal membrane oxygenation (ECMO), or renal replacement therapy (RRT) for acute kidney injury (AKI)
* Positive serum pregnancy test at screening for women of childbearing potential or currently breastfeeding
* Known hypersensitivity to the study drug, metabolites, or formulation sulfobutylether-beta-cyclodextrin (SBECD)

Note: Other protocol defined Inclusion/Exclusion criteria may apply
Safety of Undenatured Collagen Type II (UCII) Supplement in Healthy Volunteer

This study will be evaluated safety of undenatured collagen type II (UCII) supplement in 60 healthy volunteer. Liver function test, renal function test, and adverse event will be assessed.

This study will be evaluated safety of undenatured collagen type II (UCII) supplement in 60 healthy volunteer. The undenatured collagen type II (UCII) supplement 40 mg will be taken once daily for 2 months. Liver function test, renal function test, and adverse event will be assessed before and after taking for 1 and 2 months.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-60 years
* No taking collagen supplement more than 2 weeks
* No collagen and protein allergy
* No liver and renal disease
* Have a willingness to participate in the study

Exclusion Criteria:

* Uncontrolled disease
* Have complication symptom during study
* Pregnancy or lactation
* Cannot follow the protocol
* During participated in other studies
Trying a New Device for Performing Capsulorhexis in Cataract Surgery Surgery

During cataract operations a capsulorhexis is being performed. This is done in order to enable the removal of lens material while keeping the capsule intact in order to put inside the lens capsule an artificial intra ocular lens.

The capsulorhexis must be round and with regular edge and no tears. While performing a cataract surgery we use phako emulsification machine that sends an ultrasonic wave that creaks the lens nucleus and at the same time irrigates the anterior chamber of the eye and sucks the fluid and the lens material of the creaked lens.

The round shape and the regularity of the capsulorhexis are a must in these surgeries since the lens capsule must stay intact and stable in order to enable the phacoemulsification and the implant of the artificial lens.

Today capsulorhexis are done with a bent needle or with special forceps; the act of capsulorhexis is delicate, sometime un predicted and difficult to teach. The learning curve is relatively long and difficult.

The proposed device enables a capsulorhexis which is round and has regular edges, done almost automatically and is predicted. The learning curve is short and easy. The capsulorhexis is done through the original operating wound with no need to widen it.

Planed Procedure

20 patients will be tested in this trail.

Consecutive patients that have senile cataract will be examined preoperatively as is done usually and the data of the examination will be collected/ a special attention will be given to the type of cataract and lens stability.

Systemic diseases will not be considered as exclusion criteria.

Patients with dens or mature cataract will be excluded.

Patients will be explained about the new device and those who will agree will sign a consent form.

During the cataract surgery all steps will be done as usually except of the capsulorhexis which will be done by using the new device.

The capsulorhexis will be photographed for further evaluation by a microscope camera.

After the operation the surgeon will record his impression about the convenience of using the new device, the shape and form of the capsulorhexis and its stability and any other relevant information.

Post operative follow up will be done as usually, one day, one week, 3 weeks and six weeks after operation. The results of those examinations will be recorded and collected with special attention of IOL stability, the shape of capsulorhexis and intra ocular post operative inflammation if will occur.

The data, including the surgeons' comments, shape and form of capsulorhexis IOL stability and the rest will be collected and processed.

In case in which the use of the device will not perform a round and regular capsulorhexis, or instability of the capsule will occur or a un predicted intraocular inflammation will be seen the trail will be stopped immediately

Eligibility Criteria:
Inclusion Criteria:

* senile cataract

Exclusion Criteria:

* dens or mature cataract trauma congenital instability of the lens(phacodonesis,TXF)
Respiratory Outbreak Mitigation in Long-Term Care Using Point-of-Care Testing

Outbreaks of seasonal respiratory viruses can spread rapidly in long-term care homes. Timely results for diagnostic tests remains a challenge for respiratory viruses due to the logistics of using a reference laboratory with delays leading to missed opportunities to implement virus-specific control measures to interrupt transmission resulting in larger outbreaks. Use of a point-of-care testing platform is a potential solution that provides faster results, but it is uncertain whether this translates into benefits for long-term care residents. This trial aims to assess whether rapid test results for respiratory pathogens (Influenza, COVID-19 and Respiratory Syncytial Virus) can impact the number and size of respiratory virus outbreaks in long-term care homes.


Eligibility Criteria:
Inclusion Criteria:

- Long-term care facility engaged with an Ontario Health Team overseen by Sunnybrook Health Science Centre, Michael Garron Hospital or Humber River Health

Exclusion Criteria:

* No signed statement of agreement for study participation
* Pre-existing use of a point-of-care testing platform
Testing P2Y12 Platelet Inhibitors Generics Beyond Bioequivalence

This is a pilot study that was conducted to prove the efficacy and safety of ticagrelor generically named Ticaloguard® compared to its brand Brilique® in healthy volunteers. we advocate comparing the clinical efficacy rather than simple bioequivalence comparison.

Cardiovascular diseases are the leading cause of death worldwide. Ticagrelor, is an oral antiplatelet drug used in acute coronary syndrome. Although generic drugs are approved for their bioequivalence to the original product, they are not necessarily to be therapeutically equivalent. This study was conducted to prove the efficacy and safety of ticagrelor generically named Ticaloguard® compared to its brand Brilique® in healthy volunteers. A loading dose of 180 mg ticagrelor named Brilique® or Ticaloguard® followed by a 90 mg twice daily regimen as maintenance dose was given to 14 and 15 volunteers in Ticaloguard and Brilique groups, respectively. The platelet aggregation on adenosine diphosphate (ADP) agonist was assessed at different time intervals .

Eligibility Criteria:
Inclusion Criteria:

volunteers of both sexes, aged between 18-64 years old

Exclusion Criteria:

* volunteers with any abnormalities in the complete blood count (CBC) at entry time
* those with any medical conditions contraindicated with antiplatelet therapy
* those taking aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), or any over the counter medications (OTC) that contain medication such as, antihistamines, antibiotics in the previous month
* volunteers with history of blood disorders or bleeding diathesis.
Evaluating the Utility of Continuous Positive Airway Pressure in the Treatment of High Altitude Pulmonary Edema

The primary objective is to evaluate the efficacy of continuous positive pressure on resolution of high-altitude pulmonary edema vs high flow oxygen. The secondary objective is to derive an incidence of high-altitude pulmonary edema based on the elevation and timing from which the subject arrives. Additionally, in a convenience sample of the base study population, an ultrasound evaluation for the presence of B lines in the lungs will be conducted after 2 hours.

Multicenter, double-blinded, randomized control trial. Enrollment is based on presentation to one of the treating facilities with clinical signs and symptoms of high-altitude pulmonary edema with a recent arrival at high altitude, an oxygen saturation below 85%, and radiographic evidence of noncardiogenic pulmonary edema. A total of 264 patients will be randomized 1:1 across 2 study arms: a CPAP mask set to 15cm H2O and an altered CPAP mask in which the pressure valve has been modified to deliver no positive pressure. All patients will be treated with 30mg nifedipine XR. Except for the application of positive pressure, all other interventions are performed in the context of everyday clinical practice, and thus will be equivalent for participants in both arms. Patients will be evaluated every 30 minutes for their ability to maintain an oxygen saturation of 92% with a normal respiratory rate and no signs of increased work of breathing on 2 liters of nasal cannula oxygen for a total of up to a maximum treatment length of 2 hours. The primary efficacy endpoint will be assessed every 30 minutes for 2 hours.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18 years or greater
* Oxygen saturation below 85%
* Recent arrival to high altitude
* Dyspnea and cough
* Xray revealing non-cardiogenic pulmonary edema

Exclusion Criteria:

* Pregnancy
* Age below 18
* Patients with respiratory failure requiring intubation
* Patients with altered mental status
* Patients with impaired decision-making capacity
* Patients with a history of congestive heart failure, CAD, COPD, asthma, known current pneumonia
* Extreme facial hair precluding application of CPAP