cyrilzakka/clinical-trials huggingface dataset:
Re-mineralization Effects of Sugar Free Chewing Gum Sweetened With Different Sugar-substitutes

The purpose of this study is to evaluate the clinical effect of chewing gum containing maltitol, on re-mineralization of early caries following daily chewing for 6 months by school children, compared to a xylitol gum, gum base and a no gum group.


Eligibility Criteria:
Inclusion Criteria:

* Consent Informed Consent Form signed by parent or legal guardian permitting participation of their children.
* Be cooperative and able to be examined in the whole study duration.
* Aged from 8 to 13 years.
* General Health: Good general health (in the opinion of the investigator) without clinically significant and relevant abnormalities of medical history such as diabetic, etc.
* Oral Health: Display 6 permanent front teeth and two maxillary buccal surfaces with visual evidence of active initial enamel carious lesions (de-mineralized but not cavitated); No any form of intraoral prostheses or appliances, clinical signs of severe gingivitis or periodontitis, temporomandibular joint disorders, and malocclusions or chronic onychophagia
* Oral Hygiene: have good oral health habits, brushing teeth at least once per day
* No medical or pharmacotherapy history that might affect the outcomes of the study, e.g. use of mouthwash, gels, or chewing gum containing antimicrobial agents during the previous 3 months

Exclusion Criteria:

* Disease: Presence of chronic debilitating disease, or any condition or other chronic disease which the investigators think not suitable for the study.
* Allergy/Intolerance: Be allergic to both maltitol and xylitol, oral care products, personal care consumer products, or their ingredients.
* Current Product Use: usual chewing-gum (of any kind) consumer or sugars-free candies consumer
* Clinical Study/Experiment: Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
Shamrock - Ultrasound/MR Image Fusion Guided Lumbar Plexus Block

The main objective is to complete a double-blinded randomized controlled crossover trial of lumbar plexus block with the Shamrock technique guided by ultrasound (US)/magnetic resonance imaging (MRI) image fusion vs. the Shamrock technique guided by ultrasound in healthy volunteers.

The investigators will assess block procedure-related parameters, anatomical spread of local anesthetic, and motor and sensory effects.


Eligibility Criteria:
Inclusion Criteria

* Age ≥ 18 years
* Body mass index (BMI): 18.5 ≤ BMI ≤30
* Written and oral consent to participate
* Normal healthy person (American Society of Anesthesiology Classification I)

Exclusion Criteria:

* Volunteers not abel to speak or understand Danish
* Volunteers not able to cooperate
* Allergy against the medicines used in the study
* Daily use of analgesics
* Drug abuse - according to the investigator's judgment
* Alcohol consumption greater than the recommendations of the Danish National Board of Health
* Contraindication for MRI scan (including pregnancy)
* Volunteers in whom nerve blocks are impossible due to technical reasons or infection
* Volunteers who are incompetent, eg. surrogate consent is unaccepted
Study to Assess the Pharmacokinetics of CT1812 in Older Healthy Volunteers

This an open label study to assess the pharmacokinetics of CT1812 in normal healthy volunteers.

Open label study to assess PK in 36 older healthy volunteers. Subjects will be screened 35 days prior dose to determine eligibility. On day -1 subjects will be admitted to the clinical research unit and on day 1 will be randomized to receive one of the following doses: 150 mg BID, 150 mg QD or 300 mg QD in the fed state. Subjects will be confined in the Clinical Research Unit where they will continue to receive study drug and complete safety assessments, PK and CSF draws, until day 16 when they will be discharged.

Eligibility Criteria:
Inclusion Criteria:

* Men and Women 50-80 years of age, inclusively
* In good health as determined by the Investigator with no clinically significant abnormalities
* Weight between 50.0 and 100.0 kg, inclusive at Screening
* No suicidal ideation
* No active depression
* Living independently at home or in a community setting
* Able to swallow CT1812 capsule or capsules
* Non-smoker with no history of using tobacco or any nicotine-containing products
* Subjects with negative serology for HIV, Hepatitis B, and C
* Negative results for drugs of abuse, cotinine, and alcohol
* Negative test results for COVID-19
* Willing to comply with Clinical Pharmacology Unit's COVID-19 policies

Exclusion Criteria:

* Any chronic medical condition which, in the opinion of the investigator, might pose a safety risk to the subject or interfere with study interpretation
* Subject with active or recent infection requiring antibiotic therapy
* Medical history of vasculitis or any autoimmune disease
* Any recent hospitalization
* Subjects living in a continuous care nursing facility
* Any contraindication to a lumbar puncture
* Subjects with self-reported history of major depression
* History of diabetes
* Intake of drugs or substances potentially involved in clinically significant induction or inhibition of CYP3A4 or P-gp mediated drug interactions with CT1812
* Intake of investigational drug prior to study drug administration on Day 1
* Participation in an investigational device study prior to study drug administration on Day 1
* Grapefruit, grapefruit juice, and Seville oranges/juice must be avoided within 14 days prior to dosing and throughout the course of the study
* Suspected or known drug or alcohol abuse,
* Excessive consumption of coffee, tea, cola, or other caffeinated beverages
* Loss or donation of blood; nation of bone marrow or peripheral stem cells; or donation of plasma
* Venous access considered inadequate; history or evidence of adverse symptoms associated with phlebotomy or blood donation
* Suspected or known allergy to any component of the study treatments
* Employee or family member of the Investigator, study site personnel, or Sponsor
* A subject with any condition that, in the opinion of the Investigator, makes the subject unsuitable for study participation will be excluded
Effects of Glucagon-Like Peptide-1 Analogs on Sexuality

This placebo-controlled, double-blind crossover study is to evaluate the GLP-1 analogue dulaglutide regarding changes in sexuality, the mood and the reproductive axis in healthy men.

This placebo-controlled, double-blind crossover study is to evaluate the GLP-1 analogue dulaglutide regarding changes in sexuality, the mood and the reproductive axis in healthy men.

The study consists of following two phases:

* Phase a (V1a-Ev2a): baseline evaluation (V1a), application of the trial medication (dulaglutide or placebo) during 4 weeks (V1a-V4a), evaluation of the primary and secondary outcomes (V2a-V4a, Ev1a), followed by a washout period of at minimum 28 days before evaluation of the last secondary outcome (Ev2a) and cross-over
* Phase b (V1b-Ev2b): baseline evaluation (V1b), application of the trial medication (dulaglutide or placebo) during further 4 weeks (V1b-V4b), evaluation of the primary and secondary outcomes (V2b-V4b, Ev1b), followed by a washout period of at minimum 28 days before evaluation of the last secondary outcome (Ev2b) and study end after study termination visit (STV).

Eligibility Criteria:
Inclusion Criteria:

* Healthy men with normal weight (BMI 18.5-25kg/m2 or BMI 25.1-30kg/m2 and waist circumference \<102cm)
* Written informed consent
* Active sex life (sex with partner or masturbation ≥2x/week)
* Satisfactory sex life
* No Hypogonadism (morning total testosterone ≥12mmol/l)

Exclusion Criteria:

* History of pancreatitis
* History of psychiatric disease (by questioning the participant, also regarding current psychiatric treatment)
* Daily nicotine abuse
* Alcohol consumption (\>1 glass/day)
* Substance abuse (as eg cannabis, anabolic steroids, benzodiazepines, opiates, psychostimulants)
* Regular intake of medication at any time
clOpidogrel "resIstaNce" in a Selected Population of Patients at a Tertiary Cardiovascular Center in Trinidad

The aim of this study was to determine the prevalence of clopidogrel resistance among a selected group of patients undergoing elective percutaneous coronary intervention and to observe whether there was any south-Asian (Indo-Trinidadian) predilection for HPR considering the well-established epidemiologic trends for accelerated CAD within this subgroup.

Clopidogrel, a second generation oral thienopyridine, remains an integral component of dual antiplatelet therapy (DAPT) in the management of cardiovascular disease (CVD) for almost two decades. Several studies underscore the importance of high on-treatment platelet reactivity (HPR) as a prognosticator for cardiovascular events including stent thrombosis. This phenomenon is often alluded to as "clopidogrel resistance" and yet to be clearly defined. Generally, it reflects the failure to achieve its antiaggregatory effect. Clopidogrel response is both complex and multifactorial, determined by a multitude of intrinsic and extrinsic mechanisms including genetic polymorphisms of the P2Y12 receptor, drug-drug interactions, and clinical factors such as suboptimal dosing regimens, acute coronary syndromes, diabetes mellitus, and possibly smoking.

High pre-treatment platelet reactivity may lead to mitigated clopidogrel-induced antiplatelet effects and are more commonly observed in specific clinical scenarios such as ACS, increased body mass index, and diabetes mellitus, in particular, insulin-dependent diabetes mellitus. Matetzky et al also surmised that nearly one-quarter of ST-segment elevation acute coronary syndrome patients would incur stent thrombosis due to this phenomenon.

Overall, HPR prevalence in various studies is estimated at 5%-44%, however, these are based on largely Caucasian populations and yet to be ascertained in a Caribbean subpopulation. Trinidad and Tobago has an ethnically diverse population with approximately one-third South Asian (Indo-Trinidadian), one-third Caribbean Black (Afro-Trinidadian) and the remaining one-third, mostly interracial and mixed. CVD is currently the leading cause of mortality in Trinidad and Tobago, accounting for up to 60% of all deaths annually.

Eligibility Criteria:
Inclusion Criteria:

* above 18 years of age
* diagnosed with stable angina awaiting elective coronary angiography on dual antiplatelet therapy for at least 3 months with aspirin 81 mg per day maintenance dose and "brand name" clopidogrel 75 mg per day maintenance dose

Exclusion Criteria:

* generic clopidogrel, i.e. not "brand name,"
* recent acute coronary syndrome within 6 months
* active bleeding
* prior cerebrovascular event
* clinical instability after an index event
* use of an oral anticoagulation agent (coumadin derivative or other anticoagulant therapy (such as dabigatran, rivaroxaban or apixaban)
* platelet count \< 100 x 106/µL
* hemoglobin \< 10 g/dL
* serum creatinine \> 2.5 mg/dL
Intraarterial Stem Cells in Subacute Ischemic Stroke

Stroke is a leading cause of morbidity and mortality.Acute ischemia causes irreversible damage to neurons and glial cells, leading to functional deficits and chronic sequelae with variable degrees of spontaneous recovery of function. Stem cells have been shown to enhance recovery through multiple immunomodulatory effects, neoangiogenesis and neurogenesis.

We conducted a prospective randomised end observer blinded study to evaluate primarily the safety of intraarterial autologous stem cells delivered to ipsilateral middle cerebral artery in acute and subacute stroke patients (0-15 days post ictus).Secondarily we aimed to evaluate the outcome on the basis of clinical evaluation and follow up imaging

1. This study was done over a period of one and a half years from July 2015 to December 2016. A total of 229 patients who presented with acute middle cerebral artery stroke and admitted at Post graduate institute of medical education and research were evaluated for recruitment into this study.
2. Participants who satisfied the inclusion criteria were randomized at 1 week into control and stem cell infusion test group within 15 days of stroke onset.
3. Investigators evaluated 20 patients, with 10 each in control and stem cell infusion test group.
4. Participants in the test group were infused autologous bone marrow mononuclear cells through intraarterial route using a microcatheter which was placed in proximal ipsilateral M1 segment of MCA. Participants in the control group did not receive stem cell therapy. Rest of the pharmacological treatment and physiotherapy were similar in both groups for the period of 6 months.

5,Participants were evaluated with clinical and radiological follow up at 6 months.

Eligibility Criteria:
Inclusion Criteria: Requires presence of all of the following

1. Age range 20-80 years symptoms
2. Signs of clinically definite MCA stroke (0 to 14 days post ictus)
3. National Institute of Health Stroke Scale (NIHSS)\> 7,
4. Stroke clinically and on imaging conforming to the MCA territory,
5. Recanalization/patency of involved M1 segment of MCA on imaging
6. Patency of carotid arteries for intra-arterial access of cerebral circulation

Exclusion Criteria: Requires presence of any of the following

1. cerebral hemorrhage on CT/MRI
2. Imaging evidence of M1-MCA segment complete occlusion
3. Hemodynamic instability
4. Known defect of clotting or platelet function
5. Severe co-morbidity precluding intra-arterial intervention
6. Hepatic or renal dysfunction
7. Pregnant patients
8. Patient likely to be unavailable for follow-up
9. Patients with evidence of chronic illness or advanced cancer
10. Patient already dependent in activities of daily living before the present acute stroke i.e. pre stroke mRS \>3
11. Refusal to give informed consent
Exercise Training in Patients With Hypertrophic Cardiomyopathy

Exercise training (ET) is highly beneficial in heart failure patients and has been suggested to confer significant symptomatic and functional improvements in patients with diastolic dysfunction. Accordingly, the aim of this study was to examine the safety, feasibility of a structured ET program in symptomatic HCM patients.


Eligibility Criteria:
Inclusion Criteria:

* Hypertrophic Cardiomyopathy
* NYHA 3
* Maximal left ventricular wall thickness \> 20 mm
* Age \>18

Exclusion Criteria:

* Severe non-cardiac limitations of functional capacity such as neurological illness, lung disease, peripheral vascular or orthopedic problem, etc.
* Patients state post resuscitation for malignant ventricular arrhythmia.
* History of effort induced syncope, complex ventricular arrhythmia or atrial fibrillation.
* An exercise-induced decrease in blood pressure
* Severe left ventricular outflow obstruction defined as resting outflow gradient \> 50 mmHg on maximal therapy
* Atrial fibrillation with a poorly controlled ventricular response
* Advanced hypokinetic stage of HCM defined as LVEF \< 40%
* Congestive heart failure of angina FC IV according to NYHA or CCS respectively.
Corestability Training in Overweight Children

A total of 52 overweight children aged between eight and sixteen years will be recruited by criterion based purposive sampling to participate in the two groups pretest post test randomized clinical study. Random allocation of the eligible subjects for treatment will be done by the block randomization method with matrix of thirteen rows and four columns (13x4). The subject will be allotted to the group randomly, based on the chit selected by the person other the primary researcher.Once the block is filled, the next row block will be opened. Thus equal distribution of overweight children in the each group will be ensured.

Group A will be receiving actual core stability training (Level 1 - Mat exercises and Level 2 - Swiss Ball exercises) for 6 weeks with a frequency of three sessions per week.Group B will receive no training. Each session will last for 30 minutes of duration. The static and dynamic balance, foot pressure distribution and core strength will be assessed at the baseline and at the end of the treatment sessions.


Eligibility Criteria:
Inclusion Criteria:

1. Children of age 8- 16 years old.
2. Both Boys and Girls.
3. Child with BMI-for-age percentile growth between 85th to less than 95th percentile.

Exclusion Criteria:

1. Uncooperative participants.
2. Upper or lower limb fracture or injury in recent 6 months.
3. Any musculoskeletal or neurological disorder affecting core strength and balance.
4. Refuse to participate because not able to understand the researcher instructions.
5. Unable to attend the whole sessions during the research period.
Holistic Needs Assessment in Outpatient Cancer Care

This study evaluates the impact of holistic needs assessment (HNA) on patient/clinician communication in outpatient cancer care. Half of the participants will complete a HNA prior to their clinical consultation. They will then take it into the consultation and it will inform a discussion around any identified areas of need. Half of the participants will be in the control group meaning there will be no additional intervention they will receive care as normal. The consultations will be audio-recorded. The patient will complete two outcome measures following the consultation.

Holistic needs assessment is a checklist completed by the patient prior to consultation. It signposts issues of emotional, practical, financial and clinical concern. The purpose of a HNA is to identify patient's individual needs in order to facilitate better collaboration. During consultation the HNA facilitates a dialogue that will have the patient's concerns at the centre. In conjunction with a subsequent care plan the process supports timely intervention based on a collaborative, person centred discussion. However, there is little evidence on how HNA impacts upon the dynamics of the clinical consultation. This study aims to establish a) how HNA affects the type of conversation that goes on during a clinical consultation and b) how these putative changes impact on shared decision-making and self-efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Over 18, capable of informed consent and expresses a wish to participate.
* Diagnosed with cancer and attending a post-treatment out-patient oncology clinic.

Exclusion Criteria:

* Individuals not diagnosed with cancer.
* Non English speaker
* Person deemed incapable of consenting to participate as defined by the Adults with Incapacity Act (2000)
* Any reason which in the opinion of the clinician/investigator interferes with the ability of the patient to participate in the study
Prospective Clinical Trial of the LensAR Laser System

The LensAR Laser System is used to create an opening in the anterior capsule of the lens and fragments the cataractous lens. The study will evaluate clinical outcomes compared to the contra-lateral eye treated with conventional phacoemulsification surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must sign and be given a copy of the written informed consent form
* Subjects must have elected to undergo lens extraction and IOL implantation and then elect to have the LensAR laser surgery as part of the procedure.
* Subjects must be willing and able to return for scheduled follow-up examinations for 6 months after surgery.
* Subjects must have central 7 mm of clear cornea without vascularization.

Exclusion Criteria:

* Subjects who have undergone previous corneal or intraocular surgery in the eye to be treated.
* Subjects with a history, signs or symptoms of ocular disease or atypical finding which would be contraindicated under standard of care for cataract surgery.
* Diabetic or hypertensive subjects with clinical evidence of retinal pathology.
* Subjects with macular degenerative pathology.
* Subjects with a history of steroid-responsive rise in IOP or uncontrolled glaucoma in either eye.
* Subjects with known lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.
* Subjects with corneal disease or pathology that precludes applanation of the cornea or transmission of laser wavelength or distortion of laser light.
Ultrafast Ultrasonographic Oro-laryngeal Measurement in Critically Ill Patients During Weaning From Mechanical Ventilation

In ICU, ventilatory weaning failure is common, accounting for up to 25% of extubations. These failures are largely due to swallowing disorders and laryngeal edema. Edema prevalence in ICU varies between 4 and 37%.

Post-extubation stridor is a clinical sign of upper airway obstruction and may require urgent reintubation, which is associated with increased patient length of stay, morbidity and mortality.

Identifying patients at risk is critical, and the need for reliable tools to predict the occurence of laryngeal edema is still relevant.


Eligibility Criteria:
Inclusion Criteria:

* Adults,
* Intubated and ventilated for more than 24h,
* Filing mechanical ventilation weaning criteria.

Exclusion Criteria:

* Pregnant of breast-feeding woman,
* Under guardianship patient,
* History of laryngeal tumor, stroke, paralysis of recurrent nerve, swallowing disorders,
* History of surgical laryngeal intervention or radiotherapy,
* Unplanned extubation,
* Opposition to take part in the study.
A Study To Learn About The Effects Of Pneumococcal Vaccine In People With HIV

The purpose of this study is to learn about how well a vaccine (Prevnar 13, PCV13) works in preventing disease in adults with HIV.

The diseases studied are pneumonia. Mostly the ones caused by the bacteria - pneumococcus. This study also evaluates the type of pneumonia that is spread into the bloodstream.

All participants in the study will be identified in health care databases. Adults with HIV will be identified by looking for a medical diagnosis that has confirmed HIV from the databases. Vaccination will be identified in the databases by looking for vaccine administration or for PCV13.

Participants will be followed in the databases to see if they have one of the diseases mentioned above or not. The number of vaccinated participants with the diseases will be compared to the number participants without the vaccines but with the diseases. This will help to understand how well the vaccine worked.


Eligibility Criteria:
Inclusion Criteria:

1. HIV infection defined as at least one inpatient or ≥2 outpatient codes related to HIV at least 30 days but no more than 730 days apart
2. At least 18 years of age at the time of the first HIV-related code
3. At least six months of continuous enrollment in medical and pharmacy plans after the first HIV-related code

Exclusion Criteria:

1. Evidence of PCV13 vaccination before the first HIV-related code