cyrilzakka/clinical-trials huggingface dataset:
Gaining Optimal Osteoporosis Assessments in Long-Term Care (GOAL)

The aim of this study is to disseminate the 2010 Osteoporosis Canada clinical practice guidelines, using a multi-faceted Knowledge Translation (KT) model, as KT aims to close the gap between knowledge generated from research and practice. The investigators' primary objective is to evaluate if this intervention can increase the percent of long-term care (LTC) residents receiving appropriate treatment for osteoporosis (i.e. treatment is considered appropriate for an individual over age 50 who has had a diagnosis of osteoporosis or a fragility fracture of the hip or vertebrae and those who have had more than one fragility fracture and is therefore considered high-risk). A secondary objective is to examine whether the intervention increases the percent of all LTC residents receiving Vitamin D equivalent to ≥800 IU/day.

Individuals who live in LTC are at high risk for osteoporosis and fractures, particularly hip fractures, which lead to pain and transfer to acute care. The investigators' previous work in LTC has shown that awareness and use of clinical practice guidelines in LTC are low. To successfully transfer knowledge, it is imperative to understand the needs of the LTC teams and to tailor KT interventions appropriately.

Interventions which focus on strategies to overcome barriers and on new ways to deliver and promote the uptake of best practices that are specific to both the learning needs of LTC health care providers and the operational/organizational culture in LTC are greatly needed. Interdisciplinary teams who participated in the Vitamin D and Osteoporosis Study (ViDOS) indicated several process barriers that may hinder the proper identification and treatment of fractures in LTC. There is a need to educate Ontario LTC practitioners on the osteoporosis guidelines. The investigators' aim is to facilitate the uptake of Osteoporosis Canada 2010 Clinical Practice Guidelines, across Ontario LTC homes using the ViDOS multi-faceted KT model. Furthermore, the investigators will have a greater emphasis on the implementation of guidelines which includes risk assessment and appropriate medication use.

Eligibility Criteria:
Inclusion Criteria:

* A minimum of 2 physicians for each LTC home served by a Pharmacy provider

Exclusion Criteria:

* LTC homes that have only one prescribing physician
Assessment of Minimal Residual Disease (MRD) After Antineoplastic Treatment in Patients With AL Amyloidosis

In this study, the investigators seek to evaluate bone marrow and blood samples and treatment responses to see if Minimal Residual Disease (MRD) can be used as a predictive method of response to treatment in amyloidosis.

In this study, the investigators seek to evaluate bone marrow and blood samples and treatment responses to see if Minimal Residual Disease (MRD) (as described below), can be used as a predictive method of response to treatment in amyloidosis.

Minimal residual disease (MRD) is a concept that has gained significant value as a prognostic predictor and has become an emerging constituent of complete response (CR) reassessment in multiple myeloma (MM) patients. Studies in MM have demonstrated that up to 30% of patients achieving a CR after high-dose therapy will still have detectable MRD in the bone marrow as measured by standard-sensitivity flow cytometry or by molecular assays. Virtually every study examining MRD in MM has reported that among patients achieving a CR, those who were MRD negative (MRD-) had a significantly superior progression-free survival, with some studies reporting superior overall survival.

As amyloidosis is a disease that is very similar to multiple myeloma, the investigators wish to evaluate the concept in this disease.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven systemic AL amyloidosis defined as
* At least one + Congo Red stain
* Proof of a clonal plasma cell dyscrasia by:
* Immunofixation electrophoresis (IFE) of the urine or serum
* Light chain restriction based on Immunohistochemistry (IHC) in bone marrow plasma cells or in the amyloid tissue
* Must be scheduled to undergo antineoplastic therapy (this may include high dose melphalan and Autologous Stem Cell Transplantation) for AL Amyloidosis (Part II enrollments only)

Exclusion Criteria:

* Co-existing Multiple Myeloma
* Prior antineoplastic treatment for AL amyloidosis at time of enrollment.
* Prior negative bone marrow biopsy showing no identifiable clone
Valsartan/Amlodipine As Compared to Losartan Treatment in Stage 2 Systolic Hypertension

This study will compare the antihypertensive efficacy and safety of a valsartan/amlodipine-based treatment with a losartan-based treatment in patients with Stage 2 systolic hypertension (high blood pressure, mean systolic blood pressure greater than 160 and less than 200 mmHg).


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatient of 18 years of age or greater
* Stage 2 systolic hypertension defined as office Mean Sitting Systolic blood pressure (MSSBP) greater than or equal to 160 and \< 200 mmHg at randomization
* Patients who were able to participate in the study, and who gave written informed consent before any study assessment was performed.

Exclusion Criteria:

* Office systolic blood pressure \>200 and/or mean sitting diastolic blood pressure (MSDBP) greater than or equal to 110 mmHg at Visit 1.
* Use of four (4) or more antihypertensive medications within 30 days of Visit 1.
* Refractory hypertension, defined as blood pressure \>140/90 mmHg while taking three (3) drugs at the maximum dose of each drug, one of which must be a diuretic. (Therapy with a fixed-dose combination of two active medications represents two drugs).
* Inability to safely discontinue all antihypertensive medications for 1-2 weeks prior to randomization.

Other protocol-defined inclusion/exclusion criteria may apply
REmotely Monitored, Mobile Health Supported Multidomain Rehabilitation Program With High Intensity Interval Training for COVID-19

Multicenter, prospective, randomized controlled trial providing mobile health supported physical rehabilitation to 120 patients who have been critically ill with COVID-19 and who complete at least one exercise session.

REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT) to improve recovery after hospital discharge in patients with COVID-19 will evaluate the feasibility of clinical-, physiological- and patient-centered outcomes associated with a remotely monitored, mobile health-supported high intensity interval rehabilitation exercise training to improve the functional recovery of survivors who have experienced critical illness with COVID-19 and have been discharged home from the hospital.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of COVID-19 requiring hospital admission
* Discharged or expected to be discharged directly home from the hospital (not to a skilled nursing facility, inpatient rehabilitation center, or long-term acute care hospital)
* Able to ambulate with or without a gait aid prior to hospital discharge
* Age ≥ 18 years

Exclusion Criteria:

* Hospital discharge \> 60 days unless readmitted to hospital in first 30 days, then 60 day window restarts and new exclusion is last hospital discharge \> 60 days
* Not ambulating independently prior to COVID-19 illness (use of a gait aid permitted)
* Functional impairment resulting in inability to exercise at baseline
* Inability or unwillingness to comply with the study requirements or unable or unwilling to follow coaching via mobile-health iPhone interaction
* Any absolute contraindications to exercise, including but not limited to:

  * Recent (\< 5 days) acute primary cardiac event
  * Unstable Angina
  * Uncontrolled dysrhythmias causing symptoms or hemodynamic compromise
  * Uncontrolled hypertension over 255 mmHg Systolic or 155 diastolic blood pressure
  * Symptomatic aortic stenosis
  * Uncontrolled symptomatic heart failure
  * Acute myocarditis or pericarditis
  * Suspected or known dissecting aneurysm
* Any adverse changes during GXT (i.e., persistent oxygen saturation drop below 88% while on prescribed oxygen therapy or significant hypotension such as mean arterial blood pressure \< 60 mmHg on 2 consecutive readings within 1 minute)
* High risk for non-adherence as determined by screening evaluation
* Any condition, including cognitive impairment, that, in the judgment of the investigator, precludes participation because it could affect subject safety or ability of subject to complete the study
* Pregnant
Effects of Music and Dance on Cognition, Frailty, and Burden in Elderly Caregivers Living in Rural Communities

This research aims to analyze the effects of senior dance on the cognition, frailty, and burden in elderly caregivers of rural communities. This is a randomized clinical trial to be conducted with a sample of 58 elderly caregivers residing in rural communities. Data collection will be performed in the homes of the elderly and/or in the dependencies of the Family Health units (USFs - primary health care systems). They will answer Socio-demographic characterization instrument, ACE-R Battery, and electroencephalography for cognitive evaluation, five Fragility criteria proposed by Fried et al and Zarit Burden Inventory. The dance protocol will be applied to the experimental group (n=29) in the USFs and the control group (n=29) will receive health care, including guidance on health care and practices. The protocols include 24 interventions, 60 minutes each, weekly, during 6 months. Analysis of effects comparisons will be conducted between groups and be comparing baseline with final measurements. Dance intervention is expected to exert important positive effects on all study variables (cognitive performance, fragility assessment, and caregiver burden), compared to the group. The intervention of the control group is expected to exert positive effects on some variables of the study (mainly, caregiver burden).

Sample Variables above described of 58 participants will be measured. The participants will be randomized to the dance group (experimental) and to the health care guidance group (control). The group will be paired by age, sex, and schooling. This study focused on prevention of cognitive performance decline, frailty and burden.

Eligibility Criteria:
Inclusion Criteria:

1. - Caregivers of elderly registered in Units of Family Health system in rural communities of São Carlos, Brazil.
2. - Over 60 years old.
3. - Living rural area.

Exclusion Criteria:

1 - Sufficient sensory or language difficulties that impede the participation of the intervention and the measurement of the variables
Effect of Left Atrial Ablation on Left Atrial Appendage Emptying Flow Velocity

Consecutive patients with paroxysmal AFib scheduled to undergo pulmonary vein isolation either with radiofrequency (RF) or cryoballoon will be included. Left atrial appendage emptying flow velocity (LAA-EFV) will be measured with transesophageal echocardiography (TEE) immediately before and following left atrial ablation (1 month post). The change in LAA-EFV will be compared between the two groups (RF versus Cryo).


Eligibility Criteria:
Inclusion Criteria:

Paroxysmal atrial fibrillation, no absolute contraindication for anticoagulation

Exclusion Criteria:

Previous cardiac surgery Previous left atrial ablation History of cerebrovascular event Presence of LAA thrombus Inability to provide informed consent
The Value of Aritficial Diet and Complex Care in Home Nutrition

Home enteral nutrition (HEN) has always been recognized as a life-saving procedure, but with the ongoing economic crisis influencing health care, its cost-effectiveness has been questioned recently.

Objective: The unique reimbursement situation in Poland enabled the otherwise ethically unacceptable, hence unavailable, comparison of the period of no-feeding and the long-term feeding and the subsequent analyses of the clinical value of the latter and its cost-effectiveness.

Background: Home enteral nutrition (HEN) has always been recognized as a life-saving procedure, but with the ongoing economic crisis influencing health care, its cost-effectiveness has been questioned recently.

Objective: The unique reimbursement situation in Poland enabled the otherwise ethically unacceptable, hence unavailable, comparison of the period of no-feeding and the long-term feeding and the subsequent analyses of the clinical value of the latter and its cost-effectiveness.

Design: The observational multicentre study in the group of 456 HEN patients was performed between January 2007 and July 2013. Two twelve-month periods were compared. During the first one patients were tube fed with home-made diet without monitoring, while during the other the complex HEN was carried out. The latter included tube feeding and complex monitoring by nutrition support team. Number of complications, hospital admissions, length of hospital stay (LOS), biochemical and anthropometric parameters and costs of hospitalization were compared.

Eligibility Criteria:
Inclusion Criteria:

* indications for home tube feeding (HTF),
* complete present and past medical history,
* tube feeding for at least twelve months before HEN and at least twelve months afterwards.

Exclusion Criteria:

* doubtful indications for HEN, no access or an incomplete medical record,
* treatment period shorter than 12 months either before or after enrolment
Approach to Predict Steroid Sensitivity in Patients With Asthma

Inhaled corticosteroids are widely used as the primary therapy for asthma, which affects approximately 20 million people in the United States. While many patients respond to corticosteroid therapy, as many as 25-30% of patients with severe asthma have asthma that is difficult to treat or steroid insensitive. Predictive biomarkers for the rapid identification of patients with asthma who will achieve adequate control of their symptoms with inhaled corticosteroids has the potential to significantly improve asthma management. This proposal is based on the hypothesis that alterations in gene expression in epithelial cells of the buccal mucosa can be used as a reliable biomarker to predict corticosteroid response in patients with asthma. The goals of this proposal will determine if gene expression in epithelial cells of the buccal mucosa from patients with asthma is in concordance with gene expression profiles that have been identified through more invasive sampling techniques of the airway epithelium of asthma patients. The Specific Aims of this proposal are to 1) investigate the level of variability in gene expression of a subset of inflammatory markers in buccal epithelium from adult patients with asthma. Aim 1 will be carried out by collecting buccal samples from three cohorts of subjects (18-55 years of age) from the Pulmonology and Allergy Clinics at Truman Medical Center during regularly scheduled outpatient visits as follows: 1) healthy control adult subjects (n=10), 2) patients with asthma treated only with a short-acting beta2-agonist (SABA, n=10), and 3) patients with asthma treated with low-dose ICS (n=10). Relative gene expression of inflammatory markers will be determined using quantitative RT (reverse transcription)-PCR and variability in gene expression will be determined within and between the three cohorts. Data from the pilot studies described in this proposal will aid in the determination of appropriate study population sizes for future investigations with the long-term objective to use changes in gene expression (in buccal epithelial cells) as a dynamic biomarker for determining corticosteroid response in patients with asthma.


Eligibility Criteria:
Inclusion Criteria:

1. healthy control adult subjects (n=10),
2. patients with mild to moderate asthma (n=20) (Table 2, Appendix 4).

A diagnosis of asthma will be defined as episodic airflow obstruction which is reversible (improvement in FEV1 \>12% when measured via spirometry) after administration of a SABA.

Exclusion Criteria:

1. currently smokers or have been smokers in the past 6 months
2. a diagnosis of COPD, bronchiectasis, Allergic Bronchopulmonary Aspergillosis, diagnosis of bacterial, fungal, or viral pneumonia in the past 6 months, or other diagnoses of chronic lung disease.
3. subjects being treated with oral systemic corticosteroids for other diseases, those using intranasal steroids in a 2 week period preceding the study, or those requiring an oral corticosteroid burst in the past 6 weeks, or who are receiving treatment with immune modulator medications will also be excluded from the study.
Observational Study on the Weight Effect of Insulin Detemir (Levemir®) in Type 2 Diabetics

This study is conducted in Europe. Observational study evaluating the body weight progress during the treatment with insulin detemir (Levemir®) in Type 2 patients, previously treated with other basal insulins


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Current treatment with insulin NPH or glargine
* The selection of the subjects will be at the discretion of the individual physician

Exclusion Criteria:

* Current treatment with insulin detemir
* Previous enrolment in this study
* Hypersensitivity to insulin detemir or to any of the excipients.
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months
A Trial Evaluating a 7-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants.

Subjects will be randomly assigned to 1 of 2 groups to receive the following vaccines: Group 1: 7-valent pneumococcal conjugate vaccine (7vPnC) and diphtheria, tetanus, and accelular pertussis vaccine (DTaP), Group 2: DTaP alone. Group 2 subjects will also receive catch-up doses of 7vPnC. The study vaccines will be open-label. The main purpose of the study is to demonstrate that the immune responses as measured by serum antibody responses to diphtheria toxin, tetanus toxin, pertussis toxin (PT) and filamentous haemagglutinin (FHA) induced by DTaP given concomitantly with 7vPnC are comparable to the immune responses induced by DTaP given alone. In addition, the study aims to evaluate the side effects (safety profile) after vaccination of 7vPnC when given with DTaP in healthy Japanese infants.


Eligibility Criteria:
Inclusion Criteria:

* Aged 3 to 6 months (defined as the first day the subject is 3 months of age to the last day the subject is 6 months of age) at time of enrollment.
* Available for entire study 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.

Exclusion Criteria:

* Previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus, or pertussis vaccines.
* A previous anaphylactic reaction to any vaccine or vaccine-related component.
* Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection.
* History of culture-proven invasive disease caused by S pneumoniae (eg, meningitis, bacteremia, osteomyelitis, arthritis).
* Subjects who are direct descendants (child, grandchild) of investigational site staff members or subjects who are direct descendants (child, grandchild) of Pfizer employees directly involved in the conduct of the trial.
Atorvastatin in Myeloma

The purpose of this trial is to study the effects of a medication already widely used to treat cardiovascular disease and diabetes, in reducing the progression of myeloma.


Eligibility Criteria:
Inclusion Criteria:

* Myeloma in remission

Exclusion Criteria:

* Adverse events (AEs) to statin, already on a statin, or contraindication to statin
New IMPLANTARY SURGERY Protocol ASSISTED BY PASSIVE ROBOTIQUE: Pilot Study

The use of a passive robotic system allows the practitioner to widen the field of indications of flapless surgical access to the implant with an increased operative security and the possibility of an operative modification of the surgical protocol.

In recent decades, the placement of dental implants has become a common procedure for the rehabilitation of partially or completely edentulous patients. The placement of implants requires good visibility of the bone support to avoid accidents such as bone fenestration. This is why, except in very favourable cases where the bone crest is wide, unconcavated and with an ideal periodontal support, it was until then necessary to proceed with a flap before placing the implant. This invasive surgical protocol necessary for implant placement with good visual access has negative parameters such as :

* detachment of the periosteum and therefore risk of bone resorption
* longer intervention time
* need for sutures
* post-operative pain. On the other hand, flapless techniques, which respect the periosteum and periodontium, offer simpler surgical outcomes, reduced risk of bleeding and infection, less bone resorption, and overall better healing. However, the absence of an access flap to the implant site requires special anatomical conditions to avoid any risk of bone fenestration during drilling, and this technique is directly related to the operator's experience. Increasing the number of cases treated by flap-free implant surgery with increased safety is now possible thanks to computer-assisted surgery and passive robotics.

The main objective is to compare the patient's post-operative pain outcomes between passive robotic implant surgery and conventional implant surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patient at least 21 years old
* Favorable diagnosis of implant placement regardless of technique (ambivalence clause)
* Radiological situation with sufficient bone volume but requiring a muco-gingival flap or the help of passive robotics.
* Affiliated or beneficiary of a social security
* Signed informed consent

Exclusion Criteria:

* Patient eligible for one or more implants and having a broad bone crest, with no marked concavity, and covered with a sufficient amount of keratinized attached gum.
* Patient with limited oral opening
* Patient with contraindications to implant placement (valve prostheses, unbalanced diabetes)
* Photosensitive epileptic patient
* Patient refusal to participate in the study
* Pregnant or breastfeeding woman
* Patients under guardianship or curatorship