cyrilzakka/clinical-trials huggingface dataset:
Pragmatic Randomized Control Trial of Telehealth vs Standard Care in Follow-up of Patients With Chronic Conditions

The Norwegian health authorities has initiated a three-year trial of telehealth solutions as part of the treatment of patients with chronic illness in the period 2018-2021. Within the trial, telehealth indicates that patients are followed-up outside health-care facilities using information and communication technologies (ICTs). Patients who are followed up using telehealth solutions can answer questions about their own health and/or perform measurements related to their health (e.g. blood pressure, blood glucose, oxygen measurement, weight) via a tablet according to a personalized schedule. The measurement values are transferred from the measuring devices to a tablet so that the users can easily see them and track their results over time. The results are also transmitted digitally to a follow-up service, a healthcare center with nurses, who contacts the patient when needed. The follow-up service provides medical support and guidance based on the patient's needs and planned follow-up, and will, in consultation with the user, evaluate whether the user should contact the general practitioner (GP) or emergency room.

The study population of the trial includes users with comprehensive medical needs, with medium to high risk of worsening of their condition, hospitalization or increased need for health and care services.

The evaluation includes three main parts: 1) An effect evaluation which is designed as a randomized control trial, 2) a cost-benefit analysis, and 3) a process evaluation which aims to provide recommendations for how to organize and implement telemedicine in clinical practice. The primary outcomes include physical and mental health state, patient experience and use of health services.

The effect evaluation is designed as a pragmatic open label multi-center randomized control trial, with two parallel arms with 300 patients in each arm. Patients are recruited between February 2019 and June 2020.


Eligibility Criteria:
Inclusion Criteria:

* The patient has a considerable disease burden and comprehensive medical needs
* The patient has a chronic disease
* The patient has medium to high risk of worsening of their condition, hospitalization or increased need for health and care services
* The patient has a high consumption of healthcare services
* The patient has a reduced level of function
* The patient is motivated to use telehealth solutions
* The patient is likely to benefit from the use of telehealth solutions

Exclusion Criteria:

* The patient is not competent to consent
* The patient is unable to handle the tablet and the measuring equipment to be used
* The patient has a substance abuse
Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Dry Eye

The purpose of this study is to assess the safety and efficacy of iontophoretic delivery of dexamethasone phosphate ophthalmic solution using the EyeGate® II Drug Delivery System in patients with dry eye.

The objective of this study is to assess the safety and efficacy of Ocular Iontophoresis with Dexamethasone Phosphate 40 mg/mL 7.5 mA-min at 2.5 mA and Ocular Iontophoresis with Dexamethasone Phosphate 40 mg/mL 10.5 mA-min at 3.5 mA compared to placebo for the treatment of the signs and symptoms of dry eye.

Eligibility Criteria:
Inclusion Criteria:

* Have a reported history of dry eye in each eye
* Be at least 12 years of age
* Demonstrate a response when exposed to the Controlled Adverse Environment model

Exclusion Criteria:

* Have contraindications to the use of the test articles
* Have known allergy or sensitivity to the study medication or their components (including corticosteroids)
* Have any ocular infections, active ocular inflammation or preauricular lymphadenopathy
* Be current contact lens wearers or wear contacts during the study
RCT - Assessing the Benefits of the Use of a Tension Night Splint in Patients With Plantar Fasciitis

To assess whether the provision of a tension night splint (TNS) device has any additional benefit in patients with chronic plantar fasciitis, compared to routine care comprising physiotherapy \& podiatry alone.


Eligibility Criteria:
Inclusion Criteria:

1. Patients age \>18 with symptoms of plantar fasciitis for \>3 months
2. Diagnostic imaging confirming plantar fasciitis (either US or MRI acceptable)

Exclusion Criteria:

1. Current or previous partial or full-thickness tear of the Achilles tendon or plantar fascia (either clinically suspected or proven on imaging)
2. Current or previous calf muscle injury
3. Previous use of tension night splint
4. Diabetic neuropathy, or other sensory / sensorimotor disturbance
5. Lower limb vascular compromise
6. Fragile skin, or skin wounds on lower leg
7. Subjects with impaired mobility which prevents safe and effective application of the Tension Night Splint
8. Any other condition which it is thought may be aggravated by the use of a tension night splint
9. Subjects unable to give valid consent for the study
10. Subjects who state that they are unable or unwilling to undergo the home-based structured rehabilitation programme as a part of the study process
11. Subjects who are unable to attend the follow-up appointment required at the end of the study
Impact of MK-0954A on Uric Acid in the Management of Hypertension (MK-0954A-366)

This was a retrospective, chart review, observational study to assess the effect of MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg \[Hyzaar(R)\]) treatment for a period of at least three months on serum uric acid levels.


Eligibility Criteria:
Inclusion criteria:

* Participant was \>20 years and \<75 years of age on the index date (i.e., the date of initiating MK-0954A therapy)
* Diagnosed with hypertension and had received MK-0954A 50/12.5 mg for at least 3 months
* Had at least one serum uric acid measurements at baseline and one at 3 months after using MK-0954A 50/12.5 mg
* Had the following records documented in the chart during the data collection period:

  * medical history and co-morbidities (if available)
  * sitting blood pressure, serum uric acid, lipid profile test results before and after using MK-0954A 50/12.5 mg
  * serum electrolytes, serum creatinine, and pre-meal sugar (if available)
  * prescription information of all antihypertensive regimens

Exclusion criteria:

* Had been treated with diuretic or angiotensin-receptor blockers (ARBs) 2 weeks before initiated treatment with MK-0954A 50/12.5 mg
* Serum creatinine \>2 mg/dL
Remotely Administered Diet Intervention to Impact Symptom Burden in Myeloproliferative Neoplasm

Myeloproliferative Neoplasm (MPN) is a chronic blood cancer without cure. The major clinical issues in MPN are 1) an increased risk of blood clots 2) symptoms thought to be driven by chronic inflammation which in some cases can be debilitating and 3) progression to acute leukemia. The current management of MPN focuses on preventing blood clots and relieving symptoms. However, treatments that reduce symptoms such as JAK inhibitors are limited to late stage MPN patients and have significant side effects including immunosuppression, reduction in platelets, and increased risk of skin cancer. Therefore, low risk interventions are sorely needed for MPN patients that can reduce symptoms. Diet represents a low risk way to reduce inflammation, specifically a Mediterranean diet has been found to reduce inflammation in cardiovascular disease. There has been a recently completed clinical trial that demonstrated MPN patients can adopt a Mediterranean diet if given dietician counseling and curriculum. However, in order to reach a larger group of people a fully remotely administered study is necessary. This is a feasibility study to determine.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 with a diagnosis of a Philadelphia chromosome negative Myeloproliferative Neoplasm (MPN) including Essential Thrombocythemia (ET), Polycythemia Vera (PV), or Myelofibrosis (MF)
* Has access to the internet and email
* MPN-Total Symptom Score (MPN-TSS) score of ≥10 on screening survey
* Mediterranean Adherence score of ≤10 on screening survey
* English fluency (intervention requires conversations with study staff)
* In the opinion of the study team is amenable to changing one's diet

Exclusion Criteria:

* Pregnant or planning to become pregnant over the course of the study
* Has food allergies, intolerances, or other dietary restrictions which would severely limit changes to their diet toward a Mediterranean style diet (such as allergies to ALL tree nuts or olive oil)
Reminerlization Potential of GSE Gel versusCPP-ACP in Carious White Spot Lesions in Post Orthodontic Patients

Assess the effectiveness of applying grape seed extract (GSE) gel versus casein phosphopeptide-amorphous calcium phosphate (MI) paste on remineralization of white spot lesion (WSLs) in post orthodontic patients.

The development of WSLs is a challenging problem in the track of orthodontic treatment. Especially in patients wearing fixed orthodontic appliances, plaque accumulation increases around brackets and bands and the pH on dental surfaces becomes acidic.

These early lesions are willing to remineralization, arrest, reharden and revert to healthy enamel condition through a remineralization process involving the diffusion of minerals into the defective tooth structure. For this purpose various remineralizing agents such as casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) and grape seed extract (GSE) have been used.

This research is conducted for early intervention and treatment of the white spot lesions by non-invasive method.

Eligibility Criteria:
Inclusion Criteria:

* Presence of at least two WSLs on the labial surfaces of six maxillary anterior teeth that were not present before orthodontic therapy.

Exclusion Criteria:

* Severe or active periodontal disease.
* Patients had received therapeutic irradiation to the head and neck region.
* Patients had participated in a clinical trial within 6 months before commencement of this trial.
* Patients unable to return for recall appointments
* Presence of abnormal oral, medical, or mental condition (including any milk-related allergies or any medical condition involving kidneys or salivary glands).
* Presence of restorations or cavities in any anterior teeth or enamel hypoplasia, dental fluorosis, or intrinsic and extrinsic pigmentation.
Perfusion Imaging and CT -Understanding Relative Efficacy

To determine the relative efficacy of Cardiac Computed Tomography Angiography (CCTA) and Single Positron Emission Computed Tomography (SPECT) in patients with an intermediate risk of CAD.

This study is a prospective, multi-center, within-subject comparative study. One hundred fifty (150) subjects with CATH procedures are needed in the study. Approximately 300 subjects who meet all of the inclusion/exclusion criteria will be enrolled. The study population will consist of subjects with symptoms suspected of and at intermediate-risk for ischemic heart disease, which are referred for MPS for a definitive diagnosis of CAD.

Each subject will undergo the following procedures:

* A Myocardial Perfusion Study (MPS) procedure, as standard of care;
* An IV contrast-enhanced cardiac CT (CCTA) procedure;
* A CATH procedure when the MPS and/or cardiac CT examination is deemed positive or equivocal and at the discretion of the referring physicians, as a standard-of-care procedure.

When both the MPS and CCTA are normal, the subject is not required to undergo a CATH procedure, but will enter into follow-up. The research staff at each site will perform follow-up for each subject at 12 months (± 15 days) and 24 months (± 15 days) and 36 months (± 15 days) after the completion of the cardiac CT procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an intermediate probability risk for coronary artery disease.
* Subject has symptoms of suspected ischemic heart disease.
* Subject is at intermediate risk for coronary artery disease

Exclusion Criteria:

* The subject has undergone a prior CCTA within 6 months prior to entering the study.
* The subject has a documented history of CAD by CATH, myocardial infarction (MI), metal stent placement in any of the coronary vessels, or a previous coronary artery bypass graft (CABG) procedure
* The subject has hemodynamic or active clinical instability:

  * Acute chest pain (sudden onset);
  * Cardiac shock;
  * Unstable blood pressure (BP);
  * Severe congestive heart failure or acute pulmonary edema.
Physiotherapist-guided Home Exercise in Moderate to Severe MS

Physical activity is a crucial component to wellness and is associated with multiple health benefits. Persons with MS may find it challenging to participate in regular physical activity or exercise, which is activity done to improve health and/or fitness. This research will test an innovative web-based intervention to help persons with moderate-to-severe disability manage their condition through a maintenance exercise program with specialized physiotherapist guidance and support. The researchers will examine adherence to the web-based physiotherapy program compared to standard physiotherapy care. Forty-five people with MS will be randomly assigned to the web group or standard care group at a rate of 2:1. Participants in the web group will receive supported and individualized web-based physiotherapy. Participants in the standard care group will receive a written exercise program. Regular participation (adherence) in the exercise programs will be evaluated in both groups over six months. The research will also examine participant satisfaction with the programs, safety, MS symptoms, and physical function. A web-based approach may be widely accessible to persons with MS in their own homes and could support long-term participation in physical activity important to wellness.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with MS
* moderate to severe disability (PDDS 2-7)
* able to access the internet in your current living environment

Exclusion Criteria:

* already doing structured exercise more than once per week
* residing \>300km from Saskatoon (unless able to travel to Saskatoon for the appointments)
* unable to understand the intent and process of this study
Improved Pain Management in Knee Osteoarthritis-related Surgeries

In recent years, pain management coordinated with enhanced recovery after surgery (ERAS) has been widely applied and rapidly developed in orthopedics, showing promising prospects. Since 2016, our hospital has used a series of continuously improved pain management schemes for patients with knee OA who underwent total knee arthroplasty (TKA), unicompartmental knee arthroplasty (UKA), and high tibial osteotomy (HTO). Here, we retrospectively analyze these patients' clinical data to compare the effects of different pain intervention measures during the perioperative period on postoperative pain, functional exercise, hospital stay, and prognosis of the three surgical methods in an attempt to provide a feasible solution for pain management of these patients.

We retrospectively analyzed the clinical data of patients with knee osteoarthritis (OA) who received surgical treatment to provide a feasible solution for perioperative pain management of these patients. The medical records of 714 patients with knee OA who had undergone total knee arthroplasty (n=551), unicompartmental knee arthroplasty (n=92) and high tibial osteotomy (n=71) were retrospectively analyzed and the cases were divided into Groups A, B, and C, according to the continuously optimized pain management. Clinical data including anesthesia grade, surgery time, functional exercise, hospital stay, pain, emotion, complications and prognosis were compared.

Eligibility Criteria:
Inclusion Criteria:

* first knee surgery were 50-80 years old had complete clinical and follow-up data

Exclusion Criteria:

* American Society of Anesthesiologists Physical Status grade≥4 comorbidity with three or more systemic diseases long-term anxiety and depression, contraindications of painkillers, long-term alcoholism, or taking painkillers concomitant limb pain caused by spinal degeneration
A Study to Evaluate the Pharmacokinetics (PK) of Medroxyprogesterone Acetate Following an Injection of TV-46046 in Healthy Women of Reproductive Age

The primary objective of this study is to evaluate and compare the pharmacokinetic profile of Medroxyprogesterone acetate following subcutaneous administration of 3 different doses of TV-46046 and a dose of Depo-subQ Provera in healthy female participants.

The secondary objectives of the study are to evaluate and compare the safety, local tolerability, and acceptability of a subcutaneous injection of 3 different doses of TV-46046 and a dose of Depo-subQ Provera in healthy female participants.

The total duration of the study for each participant is expected to be up to 19.5 months.


Eligibility Criteria:
Inclusion Criteria:

* has regular menstrual cycle (21 to 35 days)
* has a low risk of pregnancy (ie, sterilized, in exclusively same-sex partnership, abstinent, in monogamous relationship with vasectomized partner, using nonhormonal intrauterine device (IUD), or consistently using barrier methods of contraception)
* had a normal mammogram within the last year, if 40 years of age or older

NOTE- Additional criteria apply, please contact the investigator for more information.

Exclusion Criteria:

* has multiple risk factors for cardiovascular disease (eg, smoking, obesity, hypertension, known low HDL, high LDL, or high triglyceride levels)
* has current or history of ischemic heart disease
* has active thrombophlebitis, current or past history of thromboembolic disorders, cerebral vascular disease or stroke
* has systemic lupus erythematosus
* has rheumatoid arthritis on immunosuppressive therapy
* has unexplained vaginal bleeding
* has diabetes
* has strong family history of breast cancer (defined as one or more first degree relatives with breast cancer, breast cancer occurring before menopause in three or more family members, regardless of degree of relationship, and any male family member with breast cancer)
* has current or history of breast cancer, or undiagnosed mass detected by breast exam
* has current or history of cervical cancer
* has cirrhosis or liver tumors
* has known osteoporosis or osteopenia
* has history of diagnosed clinical depression or bipolar disorder, with or without suicidal ideation, and/or history of suicide attempt, except short-lived situational depression that did not require medication and has not recurred in last five years
* used MPA-containing injectable products in the past 12 months
* used a combined injectable contraceptive in the past 6 months
* used any of the following medications within 1 month prior to enrollment:
* any investigational drug
* oral contraceptives, contraceptive ring or patch
* levonorgestrel intrauterine system (LNG IUS) or contraceptive implant
* is participating in another clinical trial
* is pregnant
* desires to become pregnant in subsequent 24 months
* has been pregnant in last 3 months
* is currently lactating

NOTE- Additional criteria apply, please contact the investigator for more information.
Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With STEMI

The objective is to compare a reduced stent strategy based on drug-coated balloon (DCB) percutaneous coronary intervention (PCI) with conventional drug-eluting stent (DES) coronary revascularization in patients presenting with ST-segment myocardial infarction (STEMI).

Randomization will be performed after successful culprit-lesion guidewire crossing and flow restoration. Random allocation in a 1:1 fashion to one of the following strategies:

* Study group: reduced stent PCI strategy (DCB-based)
* Control group: conventional PCI strategy (DES-based).


Eligibility Criteria:
Inclusion Criteria:

- Patients presenting with STEMI and indication to undergo pPCI.

Exclusion Criteria:

* Life expectancy \<1 year due 1 to non-cardiac disease.
* Inability to provide informed consent.
* Cardiogenic shock.
* Left ventricular ejection fraction \<15%.
* Left main disease.
* Stent thrombosis
* Patients with prior bypass graft lesions requiring PCI (culprit or non culprit lesions).
* Patients with chronic total occlusions.
* Untreatable coronary disease.
* Non-identified culprit lesion.
* Known allergy to aspirin, ticagrelor, prasugrel, clopidogrel, paclitaxel or sirolimus.
Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical Imaging

The use of MDS to access the presence of melanoma in the skin.

A topical agent is applied to suspicious skin lesions and imaged. The images are analyzed to provide a score that correlates with the probability for the presence of melanoma in the lesion.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with skin lesion with one or more of the ABCDE features and recommended for a skin biopsy.
* The lesion is accessible to the imaging device, with at least 1 cm of skin around the lesion that is accessible to the MDS.
* Male and female ≥ 21 years old.
* Subject is capable of giving written informed consent.
* Primary excision.

Exclusion Criteria:

* The lesion is less than 1 cm from the eyes.
* The lesion is on the palms of hands or soles of the feet.
* Mucosal lesion.
* Pregnant females.
* Low study procedure compliance.
* Patients who are mentally or physically unable to comply with all aspects of the study.
* Undergoing chemotherapy.
* Minor or legally incompetent and not able to sign the consent form.
* Patient previously tested by MDS and was diagnosed with melanoma during the study.
A Study of MK0777 Gel Extrusion Module (GEM) in the Treatment of Outpatients With Generalized Anxiety Disorder (0777-019)

The study will look at the effectiveness of MK0777 in patients with Generalized Anxiety Disorder.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Current diagnosis of Generalized Anxiety Disorder
* Age 18 - 70

Exclusion Criteria:

* Women who are pregnant, or breast-feeding
* Use of illicit drugs
* History of drug or alcohol dependence
Effect of Intake of Pyrus Pyrifolia Var. Culta(Makino) NaKai Peel Extract on Body Fat and Blood Lipid.

The investigators performed a 8-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Pyrus pyrifolia var. culta(Makino) NaKai peel extract on decrement of body fat. The investigators measured decrement of body fat parameters , including Body Fat Mass, Percent Body Fat, weight and BMI(body mass index), and monitored their blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 19-65 years old
* BMI(body mass index) 25\~29.9 kg/m\^2 or WC(Waist Circumference) ≥ 90(men), WC ≥ 85(women)
* Able to give informed consent

Exclusion Criteria:

* BMI(body mass index) ≥ 30 kg/m\^2
* Significant variation in weight(more 10%) in the past 3 months
* Allergic or hypersensitive to any of the ingredients in the test products
* History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
* History of alcohol or substance abuse
* Participation in any other clinical trials within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* Pregnant or lactating women etc.