cyrilzakka/clinical-trials huggingface dataset:
Training and Calibration of Dental Examiners

Training and calibration of dental examiners


Eligibility Criteria:
Inclusion Criteria:

* Male or female volunteers 18-65 years of age
* Good general health
* Must sign informed consent form
* Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.
* No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.

Exclusion Criteria:

1. Subjects unable or unwilling to sign the informed consent form.
2. Medical condition which requires pre-medication prior to dental visits/procedures
3. Moderate or advanced periodontal disease or heavy dental tartar (calculus).
4. 2 or more decayed untreated dental sites at screening.
5. Other disease of the hard or soft oral tissues.
6. Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
7. Use of medications that can affect salivary flow (e.g. anticholinergics, adrenergics, antihistamines, vasoconstrictors or decongestants).
8. Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
9. Pregnant or nursing women.
10. Participation in any other clinical study within 1 week prior to enrollment into this study.
11. Allergy to chlorhexidine
12. Use of tobacco products
13. Subjects who must receive dental treatment during the study dates.
14. Current use of Antibiotics for any purpose.
15. Presence of an orthodontic appliance.
16. History of allergy to common dentifrice ingredients.
17. Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
The Effect of Tracheal Intubation on AC and DC Components of a Photoplethysmograph

Intraoperative stress responses (vasoconstriction and changes in heart rate) and postoperative pain can be monitored using photoplethysmography (PPG). PPG measures changes in tissue volume noninvasively. Therefore it can measure acute changes in arterial diameter (vasoconstriction). PPG signal has two components, AC and DC. Effects of noxious stimuli-induced stress responses (vasoconstriction) have not been studied on the DC component of PPG. The aim of this study was to investigate the effect of a known noxious stimulus (endotracheal intubation) on both the AC and DC components of PPG.


Eligibility Criteria:
Inclusion Criteria:

* Elective surgery
* General endotracheal anesthesia
* Over 18 years of age
* Healthy

Exclusion Criteria:

* Vascular disease
* Liver or kidney disease
* Overweight
SLEep APnea Screening Using Mobile Ambulatory Recorders After TIA/Stroke

Obstructive sleep apnea (OSA) is common after stroke/TIA and, left untreated, is associated with recurrent vascular events, poor functional outcomes, and long-term mortality. Despite its high prevalence, OSA often remains underdiagnosed after stroke. The purpose of this study is to evaluate portable sleep monitors (PSMs) as a broad screening tool for OSA after stroke/TIA. The study investigators hypothesize that the screening with PSMs will lead to an increase in the diagnosis of treatable OSA after stroke/TIA and an improvement in sleep-related and functional outcomes.

Obstructive sleep apnea (OSA) is common after stroke and, left untreated, is associated with recurrent vascular events, poor functional outcomes, and long-term mortality. Despite its high prevalence, OSA often remains underdiagnosed after stroke. While in-laboratory polysomnography studies are the gold standard for diagnosing OSA, their use is limited by the lack of availability, patient unwillingness to sleep overnight at a laboratory and high costs. Home-based PSMs can accurately diagnose OSA and are much more accessible, convenient and low-priced compared to in-laboratory sleep studies.

The primary purpose of this study is to determine whether broad screening for OSA using PSMs, as compared to usual care, increases the proportion of patients diagnosed with treatable OSA after stroke or TIA. Secondary aims include whether screening with PSMs increases the proportion of patients treated for OSA with continuous positive airway pressure (CPAP) and whether functional outcomes and sleep-related outcomes are improved. Finally, the study will also determine whether this approach is cost-effective.

Eligibility Criteria:
Inclusion Criteria:

* Imaging-confirmed stroke or stroke-neurologist diagnosed TIA in the past 6-months, and
* Outpatients being managed at the Sunnybrook Stroke Prevention clinic or inpatients on the Sunnybrook Stroke Unit.

Exclusion Criteria:

* Prior diagnosis of OSA
* Current use of CPAP
* Life expectancy less than 12 months
* The presence of conditions known to compromise the accuracy of portable sleep monitoring, such as moderate to severe pulmonary disease or congestive heart failure
* Oxygen therapy (eg. nasal prongs), a nasogastric tube, or other medical devices that would interfere with the placement of the sensors of the sleep monitoring device and/or CPAP
* Physical impairment, aphasia, or language barrier restricting ability to complete study assessments, overnight sleep monitoring, and/or comply with CPAP therapy, and no caregiver available to assist the patient with the study requirements
* Facial or bulbar weakness or trauma restricting the ability to create a seal with a CPAP mask
* Pregnancy
* Occupation that would make randomization to the standard of care arm unethical
* Not covered by Ontario health insurance plan (OHIP)
* Unable to attend follow-up assessments
A Multi-Centre Clinical Study in Chronic Spinal Cord Injury Patients

To establish a solid foundation, e.g. network and a coordinating centre for testing new SCI therapies in forthcoming randomized controlled multi-centre clinical trials following international standards and guidelines


Eligibility Criteria:
Inclusion Criteria:

1. Male or female adult subjects, 18 to 60 years of age;
2. Have a clinical diagnosis of chronic SCI (defined as a history of ≥ 12 months suffering SCI);
3. The diagnosis of SCI was confirmed by MRI; and
4. Voluntarily signs and dates an Informed Consent Form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to any study-specific procedures

Exclusion Criteria:

1. Severe head injury;
2. Is medically or mentally unstable according to the judgement of the Investigator;
3. History of Multiple Sclerosis or peripheral demyelinating disease;
4. Likely to have experimental therapy;
5. Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol
Incidence of Significant Mitral Regurgitation in Acute Heart Failure Patients

The purpose of this study is to determine the prevalence of moderate-to-severe Mitral Regurgitation (MR) in acute Heart Failure (HF) patients requiring hospital admission.

All patients admitted with symptoms of HF- (shortness of breath (SOB), peripheral oedema, palpitations and irregular heart beats) will be assessed by the Research Team. The level of BNP will be checked using a small device (i-STAT BNP) at the bedside. If results of the test suggest HF they will undergo special procedure called transthoracic echocardiography (TTE). TTE is an ultrasound scan of the heart which will enable the investigators' to grade severity of Mitral Regurgitation (MR) as well as strength of the heart muscle. The investigators will use bi-plane Simpton's method to calculate left ventricular (LV) ejection fraction (EF). Colour Doppler and PISA method will be used to quantify severity of MR or valve leak. Simultaneously there will be recording of heart sounds to find out if auscultation is reliable in identifying leaky valves.

Eligibility Criteria:
Inclusion Criteria:

* Acute Heart Failure patients admitted to the Hospital
* Elevated BNP level (\>30pg/ml)

Exclusion Criteria:

* Patients with BNP level (\< 30pg/ml)
Impact Evaluation of Different Micturition Modes on Patients With Medullar Injury of Quality of Life and Their Occupations

The primary objective of the study is to analysis the personal determination factors (age, sex, stage of injury, pain, urinary continence and durations of spinal cord injury) and environmental determination factors (need for medical devices, nurse care and adaptation of accommodations) which affect the quality of life and their occupations on patients with medullar injury.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with spinal cord injury;
* Live at home or in long-term care facility definitively;
* Have one of the following urination modes:

  1. urine with indwelling catheter in place
  2. catheter in suprapubic area
  3. intermittent catheterization by urethra
  4. intermittent catheterization by incontinent cystostomy
  5. sphincterotomy
  6. incontinent stomia (Bricker)

Exclusion Criteria:
SLI MANEUVER and RESPIRATORY MORBIDITIES

Purpose: The investigators hypothesis is that, as compared to the only nCPAP-applied group, application of SLI maneuver followed by respiratory support with nCPAP immediately afterwards in preterm infants at high risk for RDS would reduce the need for intubation and mechanical ventilation in early period and ultimately will improve respiratory outcomes.

Primary Outcome Measures:

Surfactant need, intubation and mechanical ventilation needs within the first 72 hours of life in SLI (Sustained Lung Inflation) maneuver-applied preterm infants and non-SLI-applied preterm infants.

Secondary Outcome Measures:

* Heart rate, fractional inspiratory oxygen, CPAP pressure and oxygen saturation within the first 72 hours of life in preterm infants
* Total non-invasive, invasive respiratory support time
* The presence of and the degree of BPD (Bronchopulmonary dysplasia)
* Premature morbidities such as PDA (patent ductus arteriosus), IVH (intraventricular hemorrhage), NEC (necrotizing enterocolitis), ROP (retinopathy of prematurity)
* Feeding intolerance, reaching birth weight and transition to full oral feeding time

Study Design Randomization Group 1: Group that received SLI maneuver immediately after birth followed by nCPAP.

Group 2: Group that received nCPAP after birth. Following the oral and nasal aspirates, SLI at 25 cm H2O pressure will be applied for 15 seconds by using t-piece refreshing and binasal prongs and 5-cm nCPAP at H2O pressure will be applied.

Patients will be observed for 5-10 seconds in terms of cardiorespiratory functions following SLI maneuver. If respiratory failure continues during nCPAP (such as apnea, gasping) and/or heart rate is \> 60 / min but \< 100 / min , SLI maneuver will be repeated at the same pressure for the same time period. If heart rate \> 60 / min but \<100 / min persists after the second SLI maneuver, resuscitation will be applied in line with the guidelines of American Academy of Pediatrics.

The control group of infants will receive nCPAP support at 5 cm H2O pressure and be supported in line with the guidelines of American Academy of Pediatrics.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infant with gestational age of 26 weeks 0 days and 29 weeks 6 days will be included.

Exclusion Criteria:

1. Presence of major congenital anomaly,
2. Patients with hydrops fetalis and pulmonary hypoplasia
3. Consent not provided or refused
The Benefits of Early Initiation of Continual Renal Replacement Therapy in Patients With Severe Sepsis

The study will evaluate the benefit of early initiation of CRRT in the initial phase of severe sepsis in patients admitted to the ICU. Primary evaluated end-point is 28-day mortality. Secondarily evaluated end-point is length of ICU-stay, length of stay in hospital, duration of mechanical ventilation. There are two groups. One group of participants with early CRRT initiation and another group with late CRRT initiation. Reference group no CRRT.

The aim is to determine the optimal timing of initiation of CRRT with respect to the degree and duration of acute kidney injury (AKI) in ICU patients. The CRRT parameters and the duration of therapy will be monitored, depending on initial biochemical and clinical values of the patient. Part of the study is the follow-up of patients with a 3-month delay.

Eligibility Criteria:
Inclusion Criteria:

* reaching criteria of severe sepsis, ICU admission

Exclusion Criteria:

* pregnant women, younger than 18 years, reaching contraindications for initiation of renal replacement therapy
Examining the Effects of Removable Denture Use in Patients Over 60 Years of Age

Patients over the age of 60 who do not currently have any removable dentures but require them will be included in the study. Patients who will receive complete dentures and those who will receive partial dentures will be assessed in separate groups. Before the fabrication of the dentures, the Mini-Mental State Examination Test (MMSE), the physical normative value test (TUG), and the Oral Functional Capacity (OFC) scoring will be conducted. No intervention will be made to the treatment during the prosthetic treatment process.

The same questionnaires will be administered again three weeks after the completion of the prosthetic treatments. The impact of the use of removable dentures on test results will be evaluated. Additionally, during this session, patients will complete a patient satisfaction test regarding their dentures (OHIP-14 for patients with a removable partial denture indication, and OHIP-edent for patients with a complete denture indication). Patients will be called back after three months, and all tests will be repeated. The relationship between the Mini-Mental State Examination, the TUG test, and the OFC test with patient satisfaction will be assessed and any changes in test scores related to denture use will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 60
* No systemic condition that would prevent the fabrication of removable dentures
* Need for new removable dentures for both jaws
* Ability to read and understand the questions in the tests and surveys
* No barriers to communication or self-expression
* No significant physical disability affecting functionality
* No history of cancer or surgical operation in the head and neck region
* No conditions or medications that could limit test performance (e.g., Parkinson's disease)

Exclusion Criteria:

* Patients under the age of 60
* Patients who do not require new removable dentures
* Patients whose missing teeth can be restored with fixed prosthetic restorations and who do not need removable dentures
* Patients who are illiterate
* Patients with systemic conditions that prevent the fabrication of removable dentures
* Patients with conditions like Parkinson's disease that could restrict test performance or who use medications with side effects causing unwanted convulsions
* Patients with significant balance issues, who frequently lose balance while walking
* Geriatric patients with temporary or permanent memory loss
* Patients with any history of cancer in the head and neck region
* Patients with severe difficulty in communication and self-expression
* Patients who are not willing to participate in the study
Transdiagnostic Internet-delivered REBT Intervention for Adolescents' Internalizing Problems

To investigate the efficacy and mechanisms of change of an Internet-delivered transdiagnostic REBT intervention for adolescents with internalizing problems.

The main objectives of this study are to evaluate the efficacy and mechanisms of change of an Internet-delivered Rational Emotive Behavior Therapy for adolescents (12-15 years) diagnosed with a principal anxiety or depressive disorder according to DSM-5 criteria. Participants will be randomly allocated to one of the two groups: experimental (REBTonAd) and waitlist control. The intervention is structured in 8 modules and will be delivered over six weeks. Assessments will be conducted at four time points: baseline, post-treatment, 3-month follow-up, and 6-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age between 12 and 15 years
* A principal diagnosis of Social Anxiety Disorder, Generalized Anxiety Disorder, Panic Disorder, Persistent Depressive Disorder, or Major Depressive Disorder as defined by DSM-5 (APA, 2013)
* Not currently following another treatment (psychotherapy, pharmacological treatment);
* Internet access
* Ability to read and write Romanian

Exclusion Criteria:

* Suicidal ideation
* Severe depression
* Any physical and mental health acute problem that requires hospitalization
* Diagnosed with autism spectrum disorder, psychosis, bipolar disorder or mental disability
Growth Response in Girls With Turner Syndrome

This trial is conducted in Europe. The aim of the trial is to evaluate growth response of two somatropin dose regimens in girls with Turner Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Turner syndrome
* If age below 3 years, either body height below - 1 SD (standard deviation) with average growth velocity according to chronological age or body height below 0 SD with growth velocity below -1 SD according to chronological age
* If age above 3 years, body height below - 1 SD with average growth velocity according to chronological age
* Measured parental height available
* Written informed consent
Extension Study of Patients Successfully Treated by Ziprasidone in Study A1281031

Open label extension study of Ziprasidone, evaluation of safety of long term use of ziprasidone


Eligibility Criteria:
Inclusion Criteria:

* Patients who successfully completed study A1281031 (CGI score of 1 or 2 at final visit) or ZIP-NY-98035 and with QTc \<= 500 msec.

Exclusion Criteria:

* All other patients who do not fit the inclusion criteria as stated above.
The Associations of Microribonucleic Acid Gene Polymorphisms With the Risk of Ulcerative Colitis

From January 2020 to December 2024, diagnosed ulcerative colitis(UC) patients and gender- and age-matched normal controls were enrolled from the Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University. Our aim is to investigate the associations of microribonucleic acid(miRNA) gene polymorphisms with the risk and clinicopathological characteristics of UC, and to analyze the effects of miRNAs gene variations on the clinical response of vedolizumab(VDZ) treatment in UC patients.

From January 2020 to December 2024, diagnosed UC patients and gender- and age-matched normal controls were enrolled from the Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University. Genotypes of miRNAs were determined by multiplex polymerase chain reaction-ligase detection reaction technique. Chi-square test and unconditional logistic regression model were used to analyze the difference in distribution of miRNAs gene polymorphisms between UC group and normal control group, as well as the effects of miRNAs gene variations on the clinicopathological characteristics and 14-week clinical response to VDZ treatment of UC patients.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed UC based on comprehensive clinical, colonoscopy, histopathological, laboratory, and radiographic examination results

Exclusion Criteria:

* rheumatoid arthritis, systemic lupus erythematosus, intestinal tuberculosis, ischemic enteritis, radiation enteritis, tumors, etc.
Construction of a Risk Screening Tool for New Psychoactive Substance Misuse Among Adolescents and Young Adults

The goal of this observational study is to construct a risk tool available for screening young adults and adolescents at high risk of drug misuse and provides a chance for early intervention to young adults and adolescents at high risk of drug misuse, which prevent the onset and development of drug addiction in the future.The main question it aims to answer is:

1. Explore the occurrence and influencing factors of new psychoactive substance misuse among young adults and adolescents;
2. Construct a risk prediction model for new psychoactive substance misuse among young adults and adolescents and conduct internal verification of the model;
3. Based on the results of the prediction model, select the optimal model to initially form a concise scale "Screening Tool for the Risk of New Psychoactive Substance Misuse among Young Adults and Adolescents";
4. Conduct external verification of the tool, and revise and improve the screening tool, form the final version of the screening tool, and verify the application performance of the screening tool.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents and young adults who were aged 14-35 years;
* Adolescents and young adults could read and communicate in Chinese were invited to participate in this study

Exclusion Criteria:

* Adolescents and young adults who were unable to complete the questionnaire due to physical or psychological reasons.
Safety and Pharmacokinetics Study of Linzagolix in Female Subjects With Normal and Impaired Hepatic Function

The primary objective of this study is to assess the pharmacokinetics (PK) of linzagolix in subjects with varying degrees of impaired hepatic function compared to match control subjects with normal hepatic function

This is a Phase 1, non-randomized, open label, single-dose study to evaluate the effect of varying degrees of impaired hepatic function (i.e., mild, moderate, and severe Hepatic Impairment (HI)) on the PK, safety, and tolerability of linzagolix and its major metabolite, KP017.

Up to 28 adult female participants will be enrolled.

Eligibility Criteria:
Key Inclusion Criteria:

Hepatic Impaired Subjects

1. Adult female, 18-75 years of age, inclusive, at screening
2. Has a BMI ≥ 18.0 and ≤ 42.0 kg/m\^2 and weight ≥ 40 kg, at screening
3. Aside from HI, be sufficiently healthy for study participation based upon medical history, physical examination, vital signs, electrocardiograms (ECGs), and screening clinical laboratory profiles, as deemed by the Principal Investigator (PI) or designee
4. Has a score on the Child-Pugh scale at screening as follows:

   * Severe HI: ≥ 10 and ≤ 15
   * Moderate HI: ≥ 7 and ≤ 9
   * Mild HI: ≥ 5 and ≤ 6
5. Has a diagnosis of chronic (\> 6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency with features of cirrhosis due to any etiology

Healthy Subjects

1. Healthy adult female will be matched based upon age and BMI
2. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.

Key Exclusion Criteria:

Hepatic Impaired Subjects

1. Has a clinically active Grade 3 or 4 encephalopathy
2. Has fluctuating or rapidly deteriorating hepatic function within the screening period, and up to 30 days prior to Day 1, in the opinion of the PI and Sponsor
3. Has history of liver or other solid organ transplant
4. Had any major surgery within 4 weeks prior to dosing
5. Has a surgical (e.g., hepatectomy, nephrectomy, digestive organ resection) or medical condition other than HI which might significantly alter the absorption, distribution, metabolism, or excretion of linzagolix and its metabolites, or which may jeopardize the subject's safety in case of participation in the study in the opinion of the PI or designee

Healthy Subjects

1. Has any clinically significant illness, as judged by the PI or designee, within 4 weeks prior to dosing
2. Has laboratory values at screening or check-in which are deemed to be clinically significant (especially derangement within liver function test), unless agreed in advance by the PI and the Sponsor