cyrilzakka/clinical-trials huggingface dataset:
A Clinical Evaluation of the ProNOVA XR Polymer Free Drug Eluting Coronary Stent System

The objective of this study is the assessment of the performance, safety and efficacy of the ProNOVA XR Polymer Free Drug Eluting Stent System in the treatment of patients with de novo native coronary artery lesions.

This study is a prospective, single arm, multicenter registry of approximately 50 patients undergoing PCI with the ProNOVA Drug Eluting Coronary Stent System according to its Instructions for Use.

The purpose of this registry is the evaluation of the performance, safety and efficacy of ProNOVA XR DES in real-world patients. Following initial stent implantation, all patients will have clinical follow up at 30 days, at 6 and 12 months. Additionally all patients will have a angiographic F/U at 6 months to assess the late luminal loss by QCA measurements and the neointimal volume including stent apposition by intravascular ultrasound.

Eligibility Criteria:
General Inclusion Criteria:

* Patient must be at least 18 years of age.
* Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the ProNOVA XR DES and she or her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site.
* Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia)
* Patient must agree to undergo all required follow-up examinations.
* Patients of childbearing potential must have had a negative pregnancy test within 7 days before treatment, and must not be nursing at the time of treatment.

Angiographic Inclusion Criteria:

* Target lesions must be de novo lesions (no prior stent implant, no prior brachytherapy)
* Target vessel reference diameter must be between 2.25 mm and 4.0 mm by visual estimate
* Target lesion ≤ 28 mm in length by visual estimate

Exclusion Criteria:

* Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year)
* Patient has a known hypersensitivity or contraindication to aspirin, either heparin or bivalirudin, both clopidogrel and ticlopidine, cobalt, chromium, nickel, or contrast sensitivity that cannot be adequately pre-medicated
* Participation in another device or drug study or has completed the follow-up phase of another study within the last 30 days
* Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon.
Antiphospholipid Antibodies and Early Severe Preeclampsia.

The Antiphospholipid Syndrome is an immune disease where the presence of antibodies directed against cell membrane phospholipids (antiphospholipid antibodies) can cause an hypercoagulable state that causes thrombosis and obstetric complications (miscarriages, stillbirths). Since 1999 the Sapporo Criteria for Antiphospholipid Syndrome diagnosis includes the development of severe preeclampsia before 34 weeks of gestation, but this was done without solid evidence of a relation between the two. Our study will try to add information to this particular point.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 24-34 weeks
* Diagnosis of severe preeclampsia

Exclusion Criteria:

* Known antiphospholipid syndrome.
* Known presence of antiphospholipid antibodies.
* Patients with systemic lupus erythematosus.
Study of Effects of Preoperative Oral Domperidone on Gastric Residual Volume After Clear Fluid Ingestion in Patients Scheduled for Elective Surgeries

General Anesthesia requires preoperative fasting according to specific instructions. Regarding Fasting Guidelines, The American Society of Anesthesiologists (ASA) recommends patients to fast from fatty food or meat eight hours prior to surgery, non-human milk or light meal for six hours prior, breast milk for four hours prior, and clear liquids including water, pulp-free juice, and tea without milk for two hours prior to the anesthetic. ASA fasting guidelines application represents the primary method to avoid aspiration as it ensures that stomach is empty before induction of anesthesia. These guidelines cannot be applied on all cases as in urgent or emergent situations or in morbidities associated with delayed gastric emptying, like Diabetes mellitus and some neurological disorders (


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes
* aged between 18-65 years
* who are categorized by ASA physical status as I or II
* undergoing elective surgeries under general anesthesia

Exclusion Criteria:

* Patients with known or suspected delayed gastric emptying (e.g. Diabetes mellitus) -psychiatric disorders
* hypersensitivity to the study medications
* peoples undergoing surgeries that associated with high incidence of Post operative nausea and vomiting (PONV) (e.g. Cholecystectomy, gynecological, ophthalmological, otorhinolaryngological, and laparoscopic surgeries).
Management Of Patellar Fractures By Craniofacial Mesh Plate Osteosynthesis Augmented by Screws

Patellar fractures are challenging orthopedic injuries. Fractures that result in disruption of the extensor mechanism led to significant functional deficits. The goals of treatment for patella fractures include restoration of articular congruity, painless full range of motion of the knee, and recovery of extensor mechanism function.

The biomechanical construct chosen to fix patellar fractures is very important because of the subcutaneous location of the patella and the high level of force transmission that occurs through the patella during flexion and extension of the knee. Some studies have shown that during specific actions like walking or climbing downhill, the patella can see forces as high as 3200 N, equaling four to five times the standard body weight of a person. Achieving biomechanical stability during patellar fracture fixation is imperative as the stability of fixation is tested thousands of times as the knee is put through numerous cycles of flexion and extension during the recovery period. While tension band wiring with or without -K- wire, screw, or cerclage wire augmentation the most widely accepted form of treatment for patellar fractures, plate osteosynthesis is gaining popularity for certain fracture patterns. We present below a novel form of patellar fracture fixation using MatrixNEURO Contourable Mesh plates (Synthes®). Made of titanium with an incredibly low profile, these plates were initially designed for use in midface and craniofacial skeletal trauma.

However, we found that using these plates in treatment of patellar fractures has allowed stable fixation of complex, severely comminuted injuries The benefit of plate is adequate and stable reduction and maintenance of this reduction


Eligibility Criteria:
Inclusion Criteria:

patient with simple patella fractues more than 16 years.

Exclusion Criteria:

* Open fractures
* Preexisting deformity
* Ipsilateral femoral injuries
Assessing the Effectiveness of Self- and Clinician-administered Crisis Response Planning for Suicide Risk

The aim of the current project is to compare the use and preliminary effectiveness of a self-administered version of the Crisis Response Plan (CRP) in decreasing suicidal/death ideation and distress and increasing positive affect when compared to a clinician-administered version of the protocol in a sample of 150 military Veterans experiencing current death or suicidal ideation.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* US military veteran
* death or suicidal ideation/suicide attempt within the past month

Exclusion Criteria:

* non-Veteran status
* acute intoxication or active psychosis precluding provision of informed consent
* inability to communicate and comprehend English
* residence outside the United States
* lack of past-month death/suicide ideation or attempt
* lack of device connected to webcam or internet
Nutritional Intakes in Burn Patients Treated as Outpatients

Nutrition is a key component of burn care. The primary goal of nutrition is to provide adequate supply in macro and micronutrients that are necessary to maintain organ function but also to wound healing, infection control and muscle preservation.

Studies about nutrition and burn care are mainly focused on severe burn patients. There is a few or no data regarding nutrition in minor burns. Those patients rarely receive a multidisciplinary approach, at least in Belgium.

The present study aimed to describe the nutritional condition of less severe burn patients treated as outpatients in a Belgian burn center. The ultimate goal was to determine whether this population needs specific dietetics follow-up or not.


Eligibility Criteria:
Inclusion Criteria:

* Burn treated exclusively in an outpatient clinic

Exclusion Criteria:

* Not french speaking
* Psychiatric disorders
* Patient refusal
Different Methods to Minimize Blood Loss During Laparoscopic Myomectomy; A Randomized Controlled Clinical Trial

Laparoscopic myomectomy with temporary bilateral uterine artery occlusion or intramyometrial injection of diluted epinephrine will be important to reduce intraoperative bleeding, time of operation and hospitalization period after laparoscopic myomectomy.

Laparoscopic myomectomy with temporary bilateral uterine artery occlusion or intramyometrial injection of diluted epinephrine will be important to reduce intraoperative bleeding, time of operation, and hospitalization period after laparoscopic myomectomy.

This will be the first study to investigate the efficacy of Laparoscopic myomectomy with temporary bilateral uterine artery occlusion or intramyometrial injection of diluted epinephrine in minimizing blood loss during Laparoscopic myomectomy at our university.

Can Laparoscopic myomectomy with temporary bilateral uterine artery occlusion or intramyometrial injection of diluted epinephrine give better outcomes regarding intraoperative bleeding when compared to traditional laparoscopic myomectomy?

Eligibility Criteria:
Inclusion Criteria:

1. Women aged from 18 to 39 years.
2. Symptomatizing Women (heavy menstrual bleeding or subfertility).
3. FIGO stage (3-7) by ultrasound.
4. Only uterine corpus fibroid.
5. Up to three fibroids by ultrasound.
6. No previous hormonal treatment.

Exclusion Criteria:

1. Patients with bleeding tendency.
2. Patients who refuse to participate in the study or uncooperative patients.
3. Current pregnancy.
4. Any retroperitoneal surgery at pararectal space.
5. More than one cesarean delivery.
Participation Restrictions in Rheumatoid Arthritis

Objective: To evaluate what factors contribute to social participation restrictions in subjects with Rheumatoid Arthritis (RA), considering the model International Classification of Functioning (ICF).

Methods: Cross-sectional study with 81 individuals with Rheumatoid Arthritis, using instruments to measure two constructs of component social participation.

In this study the definition of social participation considered several areas, such as marriage and family, work, leisure, religion, economy, and politics which are based in the social scales of the questionnaires SF-36 and AIMS2.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years of age
* Mental capacity as assessed by the Brazilian version of Mini Mental State Examination
* Diagnosis of RA according to the American College of Rheumatology (ACR) 1987 criteria established by attending service rheumatologist.

Exclusion Criteria:

* Individuals who had undergone surgery of the upper limbs, were unable to comply with the protocol for data collection, or with non-corrected visual deficits that could interfere with their functionality were excluded
Characterization and Progression of Minor Phenomena in Parkinson's Disease (PD)

Parkinson's disease psychosis encompasses a range of symptoms, including minor phenomena, frank hallucinations, and delusions. Minor phenomena include passage hallucinations (fleeting sense of a person, animal or object passing in the periphery), presence hallucinations (feeling of nearby presence), and illusions (misrepresentation of external stimuli). Some forms of PD psychosis may be progressive. The primary objective of this study is to:

1) To determine the cumulative probability of developing hallucinations or delusions over time in individuals with PD minor phenomena followed for 36 months.


Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease (as determined by Movement Disorders Society diagnostic criteria for clinically probable Parkinson's disease)
* Parkinson's disease minor phenomena
* ≥30 years of age
* Proficient in English
* Willing and able to provide informed consent

Exclusion Criteria:

* Any current or prior history of formed hallucinations or delusions
* Current or prior treatment with an antipsychotic medication (regardless of indication)
* Diagnosis of mania with psychotic features, bipolar or related disorder, depression with psychotic features, or a psychotic disorder
* Unable or unwilling to complete study activities
* Any medical or psychiatric comorbidity that, in the opinion of the investigator, would compromise study participation
Darbepoetin Alfa Treatment of Anemia in Hemodialysis Subjects

The purpose of this study is to compare once a week and once every other week darbepoetin alfa on the change in hemoglobin levels between the screening/baseline period and the evaluation period (weeks 25-30). This study will also assess the change in mean hemoglobin over 4 week intervals, instability of hemoglobin concentrations, darbepoetin alfa dosing requirements and red blood cell transfusions.


Eligibility Criteria:
Inclusion Criteria: - -Receiving hemodialysis for at least 6 months before screening - -Clinically stable as judged by the investigator - Stable IV rHuEPO therapy administered 1, 2 or 3 times per week for at least 8 weeks before screening (stable is defined as less than or equal to 25% change \[up or down\] in weekly dose and no change in frequency over 8 weeks) - Adequate iron stores (serum ferritin greater than or equal to 100μg/L) during the screening period - Available for follow up assessments - Before any study specific procedure is carried out, the subject, or his/her legally acceptable representative must give informed consent for participation in the study Exclusion Criteria: - -Treatment for grand mal epilepsy in the last 6 months - Congestive heart failure (New York Heart Association \[NYHA\] class III or IV)- - Uncontrolled hypertension, defined as a predialysis diastolic blood pressure measurement greater than or equal to 110mmHg during the screening period - Clinical evidence of current uncontrolled hyperparathyroidism (e.g., serum parathyroid hormone greater than 1500pg/mL) within the past 12 months - Major surgery within 3 months before screening (excludes vascular access surgery) - Previously diagnosed HIV or chronic hepatitis B infection - Clinical evidence of current malignancy excluding basal cell or squamous cell carcinoma of the skin - Systemic hematological disease (e.g., sickle cell anemia, myelodysplastic syndromes, hematological malignancy); myeloma; hemolytic anemia - Alanine transaminase (ALT) and aspartate transaminase (AST) greater than 2 times the upper limit of the normal range - RBC transfusion(s) within 12 weeks before screening or during the screening/baseline period, or active bleeding - Clinical evidence of current systemic infections - Androgen therapy within 12 weeks before screening - No prior treatment with darbepoetin alfa - Currently enrolled in, or has not yet completed a period of at least 30 days since ending, other investigational device or drug trial(s). Subjects receiving other investigational agent(s) may only enter the study after discussion and agreement with Amgen - Pregnancy (women of child-bearing potential must be using adequate contraception) - Breast feeding - Psychiatric, addictive, or other disorder that compromises ability to give truly informed consent or is likely to alter compliance - Anticipating or scheduled for a living-related kidney transplant
Impact of Personality on Adherence to Tyrosine Kinase Inhibitor Therapy in Pts W/Chronic Myeloid Leukemia

This is an observational pilot study to examine the association between a patient's personality and adherence to tyrosine kinase inhibitor therapy in patients with chronic myeloid leukemia.

The purpose of this pilot study is to explore the association between personality and adherence to a specific type of oral cancer medication - tyrosine kinase inhibitor (TKI) - in patients with chronic myeloid leukemia (CML). 75 individuals with chronic phase CML who are being treated with TKIs will be recruited. Consenting patients will participate in a focused interview where TKI adherence, personality type, and quality of life and symptom burden will be assessed using validated questionnaires. Information on treatment response and the treating physician's perception of TKI adherence will be obtained from the electronic health record.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Diagnosed with chronic myeloid leukemia (CML) and in the chronic phase (CML-CP)
* Currently being treated with one of four cancer medications - imatinib, dasatinib, bosutinib, or nilotinib
* A patient at the UCI Chao Family Comprehensive Cancer Center (CFCCC), or
* A member of a patient support group organized by the CML Buster Foundation
* Do not meet any of the criteria listed under "Exclusion Requirements"

Exclusion Criteria:

* Unable to read and speak English
* Impaired decisional capacity to consent
Mass Balance and Metabolism Study of 14C-Z-215

The aim of this Phase I study is to determine the absorption, metabolism, and excretion of 14C-Z-215 in healthy male subjects following a single oral administration at a therapeutically relevant dose level (20 mg).


Eligibility Criteria:
Inclusion Criteria:

* Any race/ethnic origin
* Subjects will have a body mass index (BMI) between 18.5 and 30.0 kg/m2
* Subjects will have a body weight between 50 and 110 kg
* Subjects will have given their written informed consent to participate in the study, and to abide by the study restrictions.

Exclusion Criteria:

* Subjects who have a significant history of drug allergy, as determined by the Investigator.
* Subjects who have serum hepatitis or are carriers of the hepatitis B surface antigen (HBsAg) or the hepatitis C antibody.
* Subjects who have a positive result for the test for human immunodeficiency virus (HIV) antibodies.
* Subjects who are exposed to radiation as a result of their occupation.
* Subjects who, in the opinion of the Investigator, should not participate in this study.
Progressive Muscle Relaxation Exercises on Sleep, Fatigue, Pain in Lymphoma Patients

With regular practice, relaxation has been found to have many benefits such as reducing sensitivity to pain and fatigue, facilitating the transition to sleep, and improving quality of life. Therefore, this study was planned to examine the effects of progressive muscle relaxation exercises applied to lymphoma patients on sleep, fatigue, and pain.

A total of 18 sessions of progressive relaxation were performed, 3 days a week for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years of age
* Being able to communicate adequately
* Not having a psychiatric problem
* Those who are determined by a physician to have no physical obstacle to exercise
* Individuals who can use technological devices
* Patients who have had at least 3 cycles

Exclusion Criteria:

* Those with communication problems
* Those with psychiatric problems
* Patients doing any exercise
* Individuals with phones that do not have a voice recording feature
* Individuals with phones that do not have a WhatsApp feature
Examining the Effectiveness of a Wait List Intervention for the Management of Adolescent Eating Disorders

The current application targets patient education and enablement, implementation of best practices, continuity of care, and an improvement model to improve efficiencies by investigating whether a brief targeted intervention prior to the first formal ED assessment is efficacious in altering outcome and treatment course.

The Eating Disorder Program at the Children's Hospital of Eastern Ontario (CHEO) offers a continuum of treatment options to child and adolescent patients with eating disorders (EDs). Although our own funding has increased in recent years, so too have the number of referrals, which has resulted in lengthy wait times for therapeutic assessments by our team. The current application targets patient education and enablement, implementation of best practices, continuity of care, and an improvement model to improve efficiencies by investigating whether a brief targeted intervention prior to the first formal ED assessment is efficacious in altering outcome and treatment course. It is well known that early recognition and implementation of treatment as soon as possible after the onset of symptoms is protective in eating disorders and leads to better success rates and recovery (APA Treatment Guidelines for EDs). It is hoped that the outcome of this study will influence the way in which centers look to address the ongoing issue of lengthy wait times in hopes of offering cost-effective interventions that ultimately improve patient outcomes. By offering an added level of support to families whose referral has been initiated, we hope to ease the burden of primary care providers and increase their satisfaction as it relates to patient safety concerns and complex case management.

Eligibility Criteria:
Inclusion Criteria:

* medical stability at time of referral
* completed referral to the Eating Disorders Program

Exclusion Criteria:

* patients deemed medically unstable are triaged urgently and not eligible for study inclusion