cyrilzakka/clinical-trials huggingface dataset:
Improving DEtection of Atrial fibriLlation in Primary Care With the MyDiagnostick

Atrial fibrillation (AF) is the most common arrhythmia and a common cause of stroke. AF can be asymptomatic and remain undiagnosed. Both the prevalence of AF and the proportion of strokes related to undetected AF increases with ageing. If AF is timely diagnosed and treated accordingly with anticoagulants, disabling strokes can be prevented. In order to help physicians in diagnosing atrial fibrillation, the MyDiagnostick was developed. It is a CE certified device that is safe, user friendly and easy to use. This device is capable of detecting or excluding AF within one minute by providing a registration of lead I of the ECG.

The investigators aim to perform a 2-arm cluster randomized diagnostic trial among patients aged 65 years and over who visit the general practice. In total the investigators will include 42 general practices of which they randomly assign 21 to the MyDiagnostick arm and 21 to the control arm. All persons aged 65 years and over who visit the general practice in the MyDiagnostick arm will be asked to hold the device every time they visit the surgery during one year.

The number of newly detected cases of AF with the diagnostic screening strategy with MyDiagnostick (MyDiagnostick arm) will be compared to care as usual (control arm). Also, the number of patients treated with anticoagulants according CHA2DS2-VASc score will be compared between both arms. Finally, the investigators will assess the number of major adverse cardiovascular events (MACE), intracerebral hemorrhages and other major hemorrhages, and all-cause mortality between the arms. End points will be assessed blinded to allocation.

The investigators hypothesise that the MyDiagnostick improves the diagnosis of atrial fibrillation in primary care and with accordingly treatment will reduce adverse outcomes.

In a recent validation study performed in 200 patients visiting a cardiology outpatient clinic, the sensitivity was 100%, and specificity 96.4% with the MyDiagnostics as compared to a 12-lead ECG. Adequate comparison of this device with accordingly treatment with care as usual is needed before large scale implementation in the primary care setting can be advocated.

Eligibility Criteria:
Inclusion Criteria:

* Community dwelling persons visit the GP and aged 65 years of over

Exclusion Criteria:

* Terminal illness of such severity that anticoagulation is considered to be not appropriate in case of newly detected atrial fibrillation
* Acute situation in which GP should act instantly
* Patients with a history of AF
PVI for TVC Response

Determine the ability of changes in Plethysmographic Variability Index during tidal volume challenge to predict fluid responsiveness

The change of Plethysmographic Variability Index after tidal volume challenge as a predictor of fluid responsiveness, confirmed with the change of SVV using Flotrac advance cardiac output monitor.

To determine whether the patient is fluid responder, Fluid challenge will be performed afterwards to confirm the patient's fluid responsiveness.

We also aim to calculate the least significant change for Plethysmographic Variability Index and Philips PPV system.

Eligibility Criteria:
Inclusion:

Patients undergoing elective major surgery (estimated \> 2-hr) with general anesthesia and mechanical ventilation in supine position

Exclusion:

1. BMI \< 18.5 or \>30 kg/m2
2. Pregnant patient
3. Allergy to starch solution
4. estimated glomerular filtration rate\< 60
Treatment of Tension-type Headache With Articulatory and Suboccipital Soft Tissue Therapy

Background. Headache is one of the most common causes of consultation in primary health care and neurology in Europe. Cervical muscle tension can maintain a restriction of joint motion at the suboccipital level, facilitating the referred head pain.

Objective. To evaluate the effectiveness of two manual therapy treatments for tension-type headache.

Methods. A randomized double-blind clinical trial was conducted, for a period of 4 weeks and a follow-up at one month post-treatment. Eighty-four patients with tension-type headache were assigned to 4 groups (3 treatment groups and 1 control group). Treatments included manual therapy of suboccipital soft tissue inhibition, occiput-atlas-axis global manipulation, and a combination of both techniques. Outcome measures were: impact of headache, disability caused by headache, ranges of motion of the craniocervical junction, frequency and intensity of headache, and associated headache symptoms.

Results. After 8 weeks, there were significant improvements in impact of headache (p=0.01), disability (p=0.001), and craniocervical flexion (p=0.03) for the suboccipital soft tissue inhibition group; in headache impact and disability (p=0.000), pain intensity (p=0.02) and craniocervical flexion (p=0.004) and extension (p=0.04) for the occiput-atlas-axis group; and in impact (p=0.002), functional disability (p=0.000), headache frequency (p=0.002) and intensity (p=0.001), craniocervical flexion (p=0.008) and extension (p=0.003) and associated headache symptoms (p=0.01) for the combined therapy group, with effect sizes from medium to large.

Conclusions. Occiput-atlas-axis and combined therapy group treatments are more effective than suboccipital soft tissue inhibition for tension-type headache. The treatment with suboccipital soft tissue inhibition, despite producing less significant results, also has positive effects on different aspects of headache.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years, episodes of headaches lasting from 30 minutes to 7 days, headache having at least two of the following characteristics: \*bilateral location

  * pressing non-pulsating quality
  * mild or moderate intensity
  * not aggravated by routine physical activity.
* Participants may present photophobia or phonophobia, nausea or vomiting, pericranial tenderness, with evolution of more than three months, and they must be under pharmacological control.

Exclusion Criteria:

* Patients with other types of headache
* Headache that is aggravated by head movements
* Metabolic disorders or musculoskeletal complaints previous neck trauma
* Vertigo
* Dizziness
* Arterial hypertension
* Advanced degenerative osteoarthritis
* Neck joint stiffness
* Signs of malignancy
* Pregnancy
* Patients with cardiac devices
* Patients in process of pharmacological adaptation, and excessive emotional tension
Intensive Dietary Education to Lower Serum Phosphorus in Patients With Chronic Kidney Disease

A low phosphorus diet is recommended for patients with chronic kidney disease who exhibit high levels of phosphorus. The purpose of this study is to determine the effects of a more intensive, innovative dietary phosphorus educational intervention on reducing serum phosphorus levels, as well as improving dietary adherence, dietary satisfaction and phosphorus knowledge level in patients with chronic kidney disease.

High serum phosphorus concentration (hPhos) commonly occurs in chronic kidney disease (CKD) secondary to declining renal function. hPhos increases the risk of developing metastatic calcification, secondary hyperparathyroidism, renal osteodystrophy and cardiovascular complications. Patients with hPhos are advised to restrict their dietary phosphorus intake to 800-1000mg/d, as per National Kidney Foundations'Kidney Disease Quality Outcomes Initiative (KDOQI). Adherence to a phosphorus restricted diet is often challenging for CKD patients, as they may be required to follow various dietary restrictions, and there is significant quantities of hidden phosphorus in processed foods. This randomized controlled trial is designed to compare the effectiveness of more intensive phosphorus education (IPE) using the innovative Phosphorus Point System Tool© versus standard phosphorus education (SPE) using the Choose/Avoid list on 1) serum phosphorus levels (primary outcome) 2) dietary adherence, dietary knowledge and satisfaction in patients with pre-dialysis CKD. We hypothesize that patients receiving IPE will have lower serum phosphorus than those receiving SPE. Fifty patients attending a pre-dialysis CKD clinic with serum phosphorus \> 1.49 mmol/L will be randomly assigned to IPE or SPE and followed over 12 weeks. Serum phosphorus, dietary intakes using the 5-pass repeat 24-hour dietary recall method, dietary knowledge and satisfaction by validated questionnaires, will be measured at baseline, 6 weeks and 12 weeks. The study's findings on the impact of more intensive innovative dietary phosphorus education in patients with pre-dialysis CKD will serve towards developing best practice of care and potentially reduce long-term complications.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Patient with pre-dialysis CKD attending the Progressive Renal Disease Clinic (PRDC) at St. Michael's Hospital
* Six-month mean serum phosphorus \> 1.35 mmol/L
* Able to provide informed consent

Exclusion Criteria:

* Currently on dialysis
* Current malignancy
* Inability to use Phosphorus Point System (PPS) Tool
Matching Assessment and Treatment for Children With Disruptive Behaviour and Their Parents

This study will develop and test whether personalized profiles of children with Disruptive Behaviour Disorder (DBD) and their parents based on important psychological, emotional, and neuropsychological indicators predict their response to child cognitive behavioral treatment and Behavioral Parent Training.

To accomplish these goals, the investigators will collect psychological, emotional, and neuropsychological measures before and following cognitive behavioural therapy (CBT) for both children and parents. The investigators will use statistical modeling to determine profiles of parents of children and children aged 6-12 years with DBD based on key domains of mental health, emotion regulation, cognition, and parent-child behaviour, and observe whether these profiles allow the study team to predict which sub-groups of parents and children are most and least likely to benefit from child CBT and Behavioural Parent Training (BPT).

Eligibility Criteria:
Inclusion Criteria:

* Child is borderline/clinically at risk on the Child Behaviour Checklist (CBCL) or Teacher Report Form (TRF) (T-score greater than or equal to 60 on Externalizing Problems composite scale or a T-score greater than or equal to 65 on the Oppositional Defiant Disorder and/or Conduct Disorder scales)
* Child has clinically severe impairment in the interpersonal relations (greater than 3), functioning in schoolwork (greater than 3), or total domains (greater than 15) on the Columbia Impairment scale.
* Parent is able and willing to participate in a group treatment

Exclusion Criteria:

* Child has an ongoing query or diagnosis of Pervasive Developmental Disorder or Autism or Asperger's Disorder
* Evidence of cognitive delays or an intellectual disability (based on the Kauffman Brief Intelligence Test-2 (KBIT-2), verbal and/or IQ composite standard score below 80 or collateral information)
* Child behaviour or emotional functioning that make group participation not possible
* Child preference for individual treatment.
* Parent behaviour or emotional functioning that make group participation not possible
* Parent preference for individual treatment.
Bimatoprost Ocular Insert Compared to Topical Timolol Solution in Patients With Glaucoma or Ocular Hypertension

The objective of this Phase 2 study is to evaluate whether the Bimatoprost Ocular Insert is non-inferior to that of timolol ophthalmic solution (0.5%) at 12 weeks.


Eligibility Criteria:
Key Inclusion Criteria:

* Written informed consent
* Primary open-angle glaucoma or ocular hypertension in both eyes
* Best-corrected distance vision of 20/80 or better
* Stable visual field
* corneal thickness between 490-620 micrometers

Key Exclusion Criteria:

* Cup-to-disc ratio greater than 0.8
* significant risk of angle closure due to pupil dilation, defined as a Shaffer classification of less than grade 2 based on gonioscopy
* laser surgery for glaucoma/ocular hypertension on one or both eyes within the last 12 months
* past history of corneal refractive surgery
* past history of any incisional surgery for glaucoma at any time
* corneal abnormalities that would interfere with tonometry readings
* current participation in an investigational drug or device study or participation in such a study within 30 days of screening
* Inability to accurately evaluate the retina
Post Prandial Glucose Control Proof-of-Principle

The purpose of this study is to compare the postprandial glycemic response of subjects with type 2 diabetes when consuming a meal along with beverages containing various combinations of nutritional ingredients and fibers versus control beverage.


Eligibility Criteria:
Inclusion Criteria:

1. type 2 diabetes
2. between 21 and 75 years of age
3. male or a non-pregnant, non-lactating female, at least 6 weeks postpartum or postmenopausal or surgically sterile
4. BMI is \> 18.5 kg/m2 and \<35 kg/m2
5. HbA1c \< 9.0%

Exclusion Criteria:

1. Subject uses exogenous insulin, exenatide, or sitagliptin phosphate
2. type 1 diabetes.
3. history of diabetic ketoacidosis.
4. current infection
5. active malignancy
6. has had a significant cardiovascular event or history of congestive heart failure.
7. end-stage organ failure or post organ transplant.
8. history of renal disease.
9. hepatic disease.
10. history of gastrointestinal disorders
11. chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
12. taking any herbals, dietary supplements, or medications, other than oral hypoglycemic medications
13. clotting or bleeding disorders.
14. allergic or intolerant to any ingredient found in the study products.
Single Dose, Dose Escalation Healthy Volunteers Study Of PF-05105679

This is a two part study. The purpose of the first part (Part A) is the evaluation of the pharmacokinetics, safety and tolerability after single ascending dose of PF-05105679. The second part (Part B) of this study will focus on the exploratory pharmacodynamics of PF-05105679 using pharmacodynamics markers (cold detection) in healthy volunteers. The doses selected in Part B will have been administered previously in the Part A of the study.


Eligibility Criteria:
Inclusion Criteria:

Healthy Volunteers

Exclusion Criteria:

Standard Healthy Volunteers
Registry on WATCHMAN Outcomes in Real-Life Utilization WASP Registry

This is an observational, prospective, non-randomized, multicenter study with the following objectives: (1) to compile real-world clinical outcomes data for WATCHMAN Left Atrial Appendage Closure Technology in patients who are implanted with the WATCHMAN device in a commercial clinical setting and (2) to collect health care usage data that may be needed for reimbursement of WATCHMAN technology in certain countries.

Approximately 200 subjects will be enrolled in the study. Up to 10 sites in the Asia Pacific and Middle East regions will participate.

Primary analyses may include, but will not be limited to, the following: procedural complications, incidence of stroke and death. Descriptive statistics will be used for baseline, procedure and follow-up data collected through the study.

Each patient will be followed for a period of two years after implant according to the schedule and standard practice at the enrolling centers. There will be no additional visits, nor procedures, for subjects who participate in the study. Subjects are expected to be followed at implant, then at one post-implant visit (typically between 1-3 months of implant), and then annually through 2 years post implant. An intermediate visit may be scheduled in a number of patients, per physician discretion. In order to reliably capture patient status at study end, a follow-up window of 24 +/- 3 months will be considered acceptable for scheduling the last visit. For subjects who are not scheduled to visit the clinical for a follow-up, a subject contact (e.g. phone call) will ensure capture of the endpoint related information; however, it is recommended to perform an in-office visit for at least the first annual visit.

Enrollment is expected to be completed in 21 months; therefore the total study duration is estimated to be 48 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are eligible for a WATCHMAN device according to current international and local guidelines (and future revisions) and per physician discretion;
* Patients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center;
* Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law.

Exclusion Criteria:

* Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.
* Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion);
* The subject is unable or not willing to complete follow-up visits and examination for the duration of the study.
Registry of Patients Diagnosed With Lysosomal Storage Diseases

This is an international prospective and retrospective registry of patients with Lysosomal Storage Diseases (LSDs) to understand the natural history of the disease and the outcomes of fetal therapies, with the overall goal of improving the prenatal management of patients with LSDs.

The need for methods to track patient outcomes, clinical management, medical decision making, and quality of care are all part of current national mandates in patient safety and quality of care delivery.

The aim of this registry is to prospectively and retrospectively collect data on patients who are diagnosed with Lysosomal Storage Disease and other LSD mutations. Data collected will be used to:

1. Identify patient outcomes of therapies.
2. Improve clinical management of patients with LSDs.
3. Improve medical decision making.
4. Improve quality of care.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 0-64 with a diagnosis of a lysosomal storage disease
* Pregnant patients whose fetus has a diagnosis of a lysosomal storage disease

Exclusion Criteria:

* There are no current exclusion criteria
Alveolar Microperforation for Inflammation-Enhanced Tooth Movement During Orthodontic Treatment

The purpose of this research study is to assess the clinical effectiveness of the procedure of a minimally invasive alveolar microperforation procedure to achieve accelerated tooth movement in patients undergoing orthodontic treatment. "Accelerated tooth movement" means that using the PROPEL™ device may help complete your treatment with braces on one side of your mouth sooner than would be expected if the device were not to be used.

Following informed consent and satisfying the screening/enrollment assessments, a panoramic and periapical radiograph of the teeth designated for micro-osteoperforation treatment is to be taken. Prior to the intervention the subjects will swish 5cc of chlorhexidine for one minute, twice. Micro-osteoperforation, PROPEL™, is conducted under local or topical anesthesia AFTER the subject is banded and bonded. The procedure will be randomized to either the left or right side in each subject. Following the procedure, Chlorhexidine rinses are to begin twice a day for a week.

The subjects will be advised to take Tylenol only in case of significant pain. Subjects will be seen four to six weeks after completion of treatment for the first follow-up. Subjects will be followed up with a telephone consult 24 hours after micro-osteoperforation is performed. They will be asked if any pain medication was taken after being dismissed from the research center and if so, they will be asked the name and dose of medication taken.

Study will conclude at the 6 month follow up visit or when space on the treating side is closed.

Eligibility Criteria:
Inclusion Criteria:

* Adolescent and adult subjects ages 18-55 years old, in good general health, with adult or mixed dentition, regardless of presence of third molars.
* Subjects are American Society of Anesthesiologists (ASA) class I (ASA class I - Patients are considered to be normal and healthy).
* Periodontal or gingivitis diseases must be addressed prior to study enrollments: Probing Depth(PD)\<5mm,Gingival Index (GI)\<1,Plaque Index(PI)=1
* If any caries is present, patient will be referred to dentist for treatment and maintenance before beginning treatment
* Able to understand English, follow simple instructions and sign informed consent

Exclusion Criteria:

* Subjects who have taken any local or systemic antibiotics, corticosteroids or periodontal medications in the previous six weeks.
* Subjects with extreme skeletal class II malocclusion: Overjet\>10mm, (Pogonion to Nasion Perpendicular line)Pg-Nper\>18mm, A point Nasion B point (ANB)\>7, Sella Nasion line to Gonion Gnathion Line (SN-GoGN)\>38
* Vulnerable subjects who unable to consent for themselves
Study Evaluating Safety, Tolerability, and Immunogenicity of Meningococcal B Vaccine in Healthy Infants

The primary purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B vaccine in healthy infants.


Eligibility Criteria:
Inclusion Criteria:

* Investigators should always use good clinical judgment in considering a subject's overall fitness for trial participation. In addition, any condition that in the opinion of the investigator may interfere with the evaluation of study objectives should be carefully considered prior to enrolling subjects.
* Male or female subjects aged 2 months (42 to 98 days of age) at the time of enrollment.
* Available for the entire consented period and whose parent/legal guardian can be reached by telephone.
* Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
* Parent/legal guardian must be able to complete all relevant study procedures during study participation.

Exclusion Criteria:

* Previous vaccination with licensed or investigational vaccines: meningococcal B, meningococcal C, pneumococcal, Hib, diphtheria, tetanus, acellular pertussis, poliovirus, rotavirus, varicella, measles, mumps, or rubella.

Any of the following illnesses/conditions that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study:

* A previous anaphylactic reaction to any vaccine or vaccine-related component.
* Contraindication to vaccination with meningococcal B, meningococcal C, pneumococcal, Hib, diphtheria, tetanus, acellular pertussis, Hepatitis B (HBV), poliovirus, rotavirus, varicella, measles, mumps, or rubella.
* Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
* Known or suspected immune deficiency or suppression.
* History of culture-proven invasive disease caused by N meningitidis or Neisseria gonorrhoea.
* Major known congenital malformation or serious chronic disorder.
* Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorder such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorder.

Does not include resolving syndromes due to birth trauma such as Erb palsy.

* Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies).
* Received any investigational drugs, vaccines or devices (aside from those specified in the protocol) within 4 weeks before administration of the first dose of test article or at any time throughout the study.
* Participation in purely observational studies is acceptable.
* Infant who is a direct descendant (child, grandchild) of the study site personnel.