cyrilzakka/clinical-trials huggingface dataset:
Post Approval Study of the Commercially Available U-Motion II+ Acetabular System and UTF Reduced Stem

This is a prospective, single arm, multi-center, post-approval study designed to evaluate the short and long term clinical performance and safety in subjects receiving primary total hip arthroplasty (THA) with the U-Motion II+ Acetabular System and UTF Reduced Stem.

This is a prospective, single arm, multi-center, post-approval study designed to evaluate the short and long term clinical performance and safety in subjects receiving primary total hip arthroplasty (THA) with the U-Motion II+ Acetabular System and UTF Reduced Stem. The acetabular and femoral components will be uncemented. Study outcomes will be analyzed and published when 1.) all enrolled and implanted subjects complete their 6-week follow up, 2.) all implanted subjects complete their 2-year follow up, 3.) at the conclusion of the study.

It is anticipated that up to 200 subjects will be enrolled at up to 5 sites. The subjects will be evaluated at predetermined intervals: baseline, procedure/ discharge and 6 weeks, 3 months, 6 months, 12 months, and 24 months post treatment for primary analysis and annually up to 5 years for device survivorship. The estimated study duration from first enrollment through completion of the final report is expected to be approximately 7 years.

This study will be conducted at up to 5 investigational sites in the United States with previous clinical research experience and with adequate population of orthopedic patients requiring primary total hip arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all of the following criteria to be considered for inclusion in the study.

1. Subject is between 18 and 75 years of age
2. Subject is indicated for a unilateral or bilateral total hip arthroplasty (THA) based on the approved labeling of the device
3. Subject has no history of previous prosthetic replacement device or orthopedic surgeries on the operative hip
4. Subject is willing and able to provide informed consent to participate in the study;
5. Subject is willing and able to understand the purpose of the study, his/her role, and is available to return to the clinic/hospital for all required follow-up visits;

Exclusion Criteria:

* Subjects will be excluded if, in the opinion of the Investigator, the subject does not qualify based on approved labeling requirements or Subject Inclusion criteria.
Artificial Intelligence-Based Emergency Triage Education Tool in Enhancing Clinical Critical Thinking and Triage Practice

The study aims to develop an artificial intelligence (AI) based emergency triage education tool for providing critical thinking and questioning skills training to nursing students. It also aims to contribute valuable implications by collecting the knowledge, attitudes, and compassion aspects of nursing students toward AI-based education

The objectives of the study:

1. To evaluate the effectiveness of instructor-led and self-play pedagogy approaches in enhancing students' critical thinking by an AI-based emergency triage education tool.
2. To evaluate the effectiveness of instructor-led and self-play pedagogy approaches in enhancing students' triage skill retention by an AI-based emergency triage education tool.
3. To evaluate students' learning motivation, simulation-based experience, and usability towards AI-based technology learning.

Participants will

1. play the education tool in different pedagogy approaches
2. answer the questionnaires and receive a qualitative interview


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 or above;
2. Currently studying the NURS 225F of the Bachelor of Nursing (General) at Hong Kong Metropolitan University;
3. Able to use electronic devices to accomplish an online survey and participate in the AI-based emergency triage education tool

Exclusion Criteria:

* Currently working in emergency department
Assessing the Impact of Electronic Capture of Patient Reported Outcomes in Radiation Oncology

The goals of this study are to assess the feasibility of weekly administration of site specific patient reported assessments using an electronic platform and to explore the correlation between patient reported outcomes as well as known dosimetric prognostic factors in patients with lung, breast, head and neck, or pelvic malignancies


Eligibility Criteria:
Inclusion Criteria:

* Patients with breast cancer, lung cancer, head and neck cancer, or gynecologic cancer receiving definitive external beam radiotherapy.
* Must be ≥ 18 years of age
* Able to read, write, and speak English in order to complete patient reported outcomes.

Patients will be approached about the study at the time of consultation or at the time of simulation by their treating physicians or by a research coordinator. All patients must sign a study-specific informed consent to participate. All patients, including those who do not choose to consent to the study, will be provided with a short survey to assess health literacy using the eHealth Literacy Scale (eHEALS).

For those not consenting to the study, the survey will be de-identified and will also ask for basic demographic information including age grouping, race, education level, and type of cancer.
Cardiac Rehab Post-atrial Fib Ablation

The aim of this study is to examine the effect of a 12-week exercise-based cardiac rehabilitation intervention on the recurrence of atrial fibrillation (AF) in patients at six- and twelve-months post-ablation procedure.


Eligibility Criteria:
Inclusion Criteria:

* ● Adult patients 18 years and older.

  * Willing to participate in the study after randomization to either an intervention group (cardiac rehabilitation exercise) or a control group (usual care).
  * Able to attend two pre and post study clinic visits at a local designated Pulse Heart Institute cardiac rehab program.
  * If randomized to the cardiac rehab intervention group can attend exercise rehab visits for 3 x per week for 12 weeks (36 visits) at a designated Pulse cardiac rehab program.
  * Has an active email address and phone number.
  * Documented diagnosis of Paroxysmal and persistent Atrial Fibrillation.
  * Undergone ablation treatment and is at a minimum of 2 weeks post ablation status.
  * Compliant with medication therapy including medications for heart rate control and anticoagulant(s).

Exclusion Criteria:

* ● Does not speak English.

  * Does not have clearance to participate in the study by their attending cardiologist.
  * Documented cardiovascular disease or pulmonary/respiratory disease that would qualify the patient for Cardiac, Pulmonary or Vascular Rehabilitation at a Pulse Heart Institute rehabilitation program.
  * Dementia or cognitive impairment.
  * Unable to participate in rehabilitation exercise due to physical limitations.
  * Greater than one prior ablation procedure
  * Long standing, chronic Atrial Fibrillation
  * Patients who have undergone posterior wall isolation ablation.
Inpatient Diabetes on Corticosteroids

Despite a significant problem with out-of-control glucose levels in patients with diabetes receiving corticosteroids for a variety of illnesses, there are no published protocols addressing how to adequately treat corticosteroid-induced hyperglycemia. Investigators propose to test a protocol using scheduled dosing of NPH (Neutral protamine Hagedorn) insulin for inpatients with diabetes receiving corticosteroids. NPH insulin action is ideally timed to counteract corticosteroid-induced hyperglycemia, and the dose is added to the patient's usual insulin regimen and timed to correspond to the corticosteroid dosing regimen. Investigators will prospectively enroll eligible consented patients with diabetes who are receiving corticosteroids as part of their treatment in a large county hospital, will randomize them to intervention or control groups, and will monitor their glucose levels during their inpatient stay. The protocol will demonstrate improved control of glucose levels with minimal risk of hypoglycemia, and will provide a practical and readily implementable protocol using NPH insulin as therapy for corticosteroid-induced diabetes.

As above.

Eligibility Criteria:
Inclusion Criteria:

* Prior history of diabetes
* Able to provide informed consent
* Receiving corticosteroids while hospitalized of greater than 10 mg/d prednisone or the equivalent of dexamethasone or methylprednisolone
* Expect to be hospitalized for 48 hours

Exclusion Criteria:

* Renal failure with GFR (glomerular filtration rate) \< 30 ml/min/1.73m2
* ALT (alanine aminotransferase) \> 2 times upper normal for laboratory
Six Month Clinical Trial Assessing Efficacy and Safety of Inhaled Insulin in Type 1 Diabetes

To determine in subjects with Type 1 Diabetes Mellitus:

1. Whether glycemic control can be achieved at least as effectively with a) an intensive insulin regimen involving pre-meal inhaled insulin plus twice daily subcutaneous NPH insulin as with b) an intensive subcutaneous insulin regimen involving pre-meal regular insulin plus twice daily NPH, given as 4 injections per day. The treatment regimens differ only by the route of delivery of the short acting insulin.
2. The toleration and safety of inhaled insulin therapy and its effects after 6months, if any, on measures of pulmonary function.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 Diabetes for more than 1 year
* Stable insulin regimen of at least 2 injections per day

Exclusion Criteria:

* Any smoking within the last 6 months. Smoking is not permitted at any time during this study.
* Subjects on insulin pump during 2 months prior to screening.
* Subjects with poorly-controlled asthma, clinically significant chronic obstructive pulmonary disease, or other significant respiratory disease.
A Clinical Study to Evaluate the Safety and Effectiveness of an Investigational Product Called CT Gel

The purpose of this study is to demonstrate the safety and effectiveness of CT Gel in subjects with acne vulgaris. The hypothesis is that CT Gel is superior to Clindamycin Gel, Tretinoin Gel and Vehicle Gel for the treatment of acne vulgaris.

CT Gel is a fixed-combination product that addresses the multifactorial factors of acne vulgaris pathogenesis. Based on numerous nonclinical pharmacology studies of each active ingredient, it is expected that this new product will have three biological actions: 1) comedolytic, 2) antimicrobial, and 3) anti-inflammatory.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 12 years of age or older in good general health
* Investigator's Static Global Assessment (ISGA) score of 2 or greater at Baseline

Exclusion Criteria:

* Any nodulo-cystic lesions at Baseline
* Pregnancy or breast feeding
* History or presence of regional enteritis or inflammatory bowel disease or similar symptoms.
* Treatment with estrogens, including oral, implanted and topical contraceptives, androgens, or anti-androgenic agents for 12 weeks or less prior to study start.
* Use of topical anti-acne medications within the past 2 weeks.
* Use of topical or systemic antibiotics on the face within the past 2 weeks.
* Use of topical or systemic corticosteroids within the past 2 weeks.
* Use of systemic retinoids within the past 3 months.
* Use of astringents, toners and skin cleansers for less than 2 weeks prior to the start of the study.
* Concomitant use of facial product containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide or salicylic acid, non mild cleansers or moisturizers containing retinol, salicylic or α- or β-hydroxy acids.
* Concomitant use of mega-doses of certain vitamins, such as vitamin D (\>2000IU QD) vitamin B12, haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital.
* Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 2 weeks or during the study.
* Concomitant use of tanning booths or sunbathing.
* Known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, retinoids or excipients of the study product
* A significant medical history of or are currently immunocompromised
* Current drug or alcohol abuse. (Drug screening not required.)
* Use of any investigational therapy within 4 weeks of enrollment.
* Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.
Defining the Utility of PET/CT in the Follow-up of Patients With Solid Tumors

This is a comparison, at this VA Hospital,of routine multi-visit and multi-testing for solid tumor recurrence in four tumor groups to a limited scheduled 5 visit history/physical with PET/CT only, over a five year period. The purpose is to show through utilization of the single most sensitive and specific test currently available-PET/CT-that survival for patients in follow-up can be improved.(Plus lowering medical costs and increasing patient confidence and compliance with follow-up appointments).

Routine visits would include COLON:14 visits with cea and 6 CTs over a 5 year period plus PET/CT at last visit RECTAL: 14 visits with cea and 6 CTs and 4 procto exams over 5 year period plus PET/CT at last visit HEAD/NECK: 14 visits with 4 CTs and PET/CT at last visit LUNG:12 visits plus 4 CTs and PET/CT at last visit

Limited follow-up ALL GROUPS: a history and physical plus PET/CT at 3 month, 9 month, 18 month, 36 month and 60 month only

Eligibility Criteria:
Inclusion Criteria:

* Completed primary therapy such that no disease is evident at the time of enrollment in the study

Exclusion Criteria:

* Patients unable to consent
* Without diagnosis of colorectal cancer
* Non-small cell lung cancer or squamous cell cancer of the head and neck
* Unwilling or unable to participate in the assigned follow-up program
* Having a serum glucose at time of PET/CT greater than 180mg/dl
* Stage IV disease or with evidence of disease recurrence post treatment
* Who are not a candidate for further treatment should a recurrence of disease be identified
Study of Screening Self-management Goals on Short Term Behavior Change

The purpose of this study is to test whether having patients identify a self-management goal (health goal), prior to a visit with their primary care provider, leads to health behavior improvement over six weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years of age)
* Attending primary care visit at Lowry Family Health Center or Level One Physicians
* English- or Spanish-Speaking

Exclusion Criteria:

* Exhibit signs of cognitive impairment or significant hearing impairment
* Provider recommendation against enrolling in study
METhotrexate Therapy Effects in the Physical Capacity of Patients With ISchemic Heart Failure (METIS Trial)

The aim of the study is to evaluate the efficacy of methotrexate to improve physical capacity in patients with symptomatic ischemic heart failure.

Recent studies have showed the importance of proinflammatory mediators in the heart failure. However, there is a lack of benefit of therapies that tried to neutralize these mediators.

Methotrexate has adenosine-mediated anti-inflammatory effects in rheumatoid arthritis and psoriasis. Methotrexate limits infarct size via this adenosine-dependent mechanisms in heart of dogs (J Cardiovasc Pharmacol. 2004 Apr;43(4):574-9). A recent trial showed that this drug reduced proinflammatory mediators in patients with heart failure (Am Heart J. 2006 Jan;151(1):62-8).

These data suggest that methotrexate may improve physical capacity in patients ischemic heart failure reducing inflammation, but a randomized clinical trial is necessary to prove it.

Eligibility Criteria:
Inclusion Criteria:

* Heart failure functional class measured using the New York Heart Association classification class II, III or IV
* Left ventricular fraction \<0.45 at the ventriculography
* Angiographic coronary lesions higher than 50% or coronary lesion revascularized (coronary artery bypass or percutaneous transluminal coronary angioplasty)

Exclusion Criteria:

* Myocardial infarction in the past four months
* Coronary artery bypass or percutaneous transluminal coronary angioplasty in the past four months
* Left ventricular disfunction diagnosed during a acute coronary syndrome
* Those who require revascularization in the following 12 weeks
* Hepatic disease (ALT and AST higher than the upper limit of the reference value)
* Renal failure (plasma creatinine higher than 2.0mg/dl)
* Alcoholism (20 doses per week or more)
* Illegal drug use
* Rheumatoid arthritis or other inflammatory diseases
* Infectious disease
* Neoplasm
* Anemia (hematocrit lower than 30%)
* Currently on any anti-inflammatory drugs
* Difficulty in walking
* Unable to understand/complete the 36-item Short Form health survey (SF-36)
* Those who do not give informed consent
Study of CP-751,871 in Combination With Docetaxel and Prednisone in Patients With Hormone Insensitive Prostate Cancer (HRPC)

To test the efficacy of CP-751,871 combined with docetaxel and prednisone in the treatment of prostate cancer that is refractory to hormone therapy


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of metastatic, progressive hormone refractory prostate cancer
* Adequate bone marrow, liver and kidney function

Exclusion Criteria:

* Previous treatment with chemotherapy
Informative Exhibition for Deprescribing Benzodiazepines

The goal of this trial is to determine if an interactive and informative exhibition in the waiting room of a Primary Care Clinic can reduce the use of benzodiazepines in adults. The main question it aims to answer is:

• Does an interactive and informative exhibition reduce the number of participants using benzodiazepines? Researchers will compare benzodiazepine consumption before and after the interactive and informative exhibition implementation at study center.

Participants will receive an informative and interactive exhibition on the risks of chronic benzodiazepine use. A single informative session on the same topic will be conducted for health professionals.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between 18 and 99 years of age.
* Attended at the Baix-a-Mar Primary Care Center during the study period.

Exclusion Criteria:

* Severe mental health disease
* Displaced patients or those who do not have an assigned doctor at the center.
* Participation in another study involving an experimental intervention during the period of the present study that affects benzodiazepine prescription.
Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Asian Patients With Essential Hypertension

This study will assess the efficacy and safety of multiple doses of LCZ696 compared to olmesartan in Asian patients with essential hypertension


Eligibility Criteria:
Inclusion Criteria:

* Patients with mild-to-moderate hypertension, untreated or currently taking antihypertensive therapy.
* Treated patients (using antihypertensive treatments within 4 weeks prior to Visit 1) must have an msSBP≥150 mmHg and \<180 mmHg at the randomization visit (Visit 201) and msSBP≥140 mmHg \<180 mmHg at the visit immediately preceding Visit 201 (Visit 102 or 103).
* Untreated patients (newly diagnosed with essential hypertension or having a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to Visit 1) must have an msSBP≥150 mmHg and \<180 mmHg at both Visit 1 and Visit 201.
* Patients must have an absolute difference of ≤15 mmHg in msSBP between Visit 201 and the immediately preceding visit.

Exclusion Criteria:

* Patients with severe hypertension (msDBP ≥110 mmHg and or msSBP ≥180 mmHg).
* History of angioedema, drug-related or otherwise, as reported by the patient.
* History or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension.
* Patients who previously entered a LCZ696 study and had been randomized or enrolled into the active drug treatment epoch.

Other protocol-defined inclusion/exclusion criteria may apply.
Optimal Level of PEEP in Protective One-lung Ventilation

Protective ventilation strategy has been widely applied in the field of thoracic surgery requiring one-lung ventilation to reduce postoperative pulmonary complications. Low tidal volume, positive end-expiratory pressure (PEEP), and intermittent recruitment maneuver are key components of protective ventilation strategy. Recent evidence suggests that a tidal volume of 4-5 ml/kg should be applied during protective one-lung ventilation. However, optimal level of PEEP is still unclear. This study aims to investigate optimal level of PEEP to minimize postoperative atelectasis by comparing modified lung ultrasound score in patients applied protective one-lung ventilation using PEEP of 3, 6, or 9 cm of water during thoracic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing Video-assisted Thoracic Surgery under one-lung ventilation

Exclusion Criteria:

* Moderate to severe obstructive/restrictive pattern in preoperative pulmonary function test
* Chronic kidney disease
* Coronary artery disease
* Pulmonary hypertension
* Bilateral lung surgery
* Conversion to thoracotomy
* American Society of Anesthesiologists physical status IV or more
* Refusal to participate
Comparison of Antimicrobial Action of Sodium Hypochlorite and Polyhexamethylene Biguanide as Root Canal Irrigants

The aim of this randomized clinical trial is to compare the antibacterial effects of sodium hypochlorite (NaOCl) and Polyhexamethylene biguanide during root canal treatment .

This study will compare the antibacterial effectiveness of sodium hypochlorite and PHMB, to find out whether PHMB can be used as a substitute to NaOCL. Polyhexamethylene biguanide (PHMB), is a disinfectant solution having a broad spectrum of antimicrobial activity and is investigated as an endodontic irrigant. It is non-corrosive, non-toxic and acts by disrupting cell membrane integrity.

Eligibility Criteria:
Inclusion Criteria:

* • Patients aged 18 to 50 years

  * Both male and female patients
  * Periodontally healthy teeth as determined by Periodontal Probing
  * Patients with non-vital necrotic pulps as determined by Cold Test
  * Patients with acute apical periodontitis determined by history and clinical examination
  * Clinical Findings:

Visual: Carious tooth decay Occlusion: Hyperocclusion Pulp vitality test: Negative Periapical radiograph: Caries involving pulp space and PDL widening Percussion Test: Positive Palpation Test: Negative

• Single rooted teeth as determined radiographically

Exclusion Criteria:

* • Multirooted teeth

  * Teeth undergoing Re-endo treatments
  * Teeth with root fractures and/ non restorable determined by clinical and radiographic examination
  * Patients receiving antibiotic treatment in the past 3 months determined by history
  * Patient with Diabetes determined by history
  * Patient with history of smoking