cyrilzakka/clinical-trials huggingface dataset:
Study of the Orsiro Drug Eluting Stent System

The purpose of this study is to compare the BIOTRONIK Orsiro Drug Eluting Stent System with the Abbott Xience Prime™ Drug Eluting Stent System with respect to in-stent Late Lumen Loss in a non-inferiority study in de novo coronary lesions at 9 months.


Eligibility Criteria:
Main Inclusion Criteria:

* Subject has provided a written informed consent
* Single de novo lesion with ≥ 50% and \<100% stenosis in up to 2 coronary arteries
* The target lesion length is ≤ 26 mm
* The target reference vessel diameter is ≥ 2.25 mm and ≤ 4.0 mm

Main Exclusion Criteria:

* Evidence of myocardial infarction within 72 hours prior to index procedure
* Unprotected left main coronary artery disease (stenosis \>50%)
* Three-vessel coronary artery disease at time of procedure Thrombus in target vessel
* Target lesion involves a side branch \> 2.0 mm in diameter
* Heavily calcified lesion
* Target lesion is located in or supplied by an arterial or venous bypass graft
The Anti-oxidant Effects of N-Acetylcysteine in Chronic Obstructive Pulmonary Disease (COPD)

Chronic obstructive pulmonary disease (COPD) is a condition defined as a disease state characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of lungs to noxious particles or gases, primarily caused by cigarette smoking. The accelerated decline in lung function is closely associated with an increased number of neutrophils in the sputum and hence with higher level of airway inflammation. It becomes clear that the inflammatory process potentiates as COPD progresses and exerts damage which is irreversible. Oxidative stress is inextricably linked to the inflammatory response.

There is increasing evidence that an oxidant/antioxidant imbalance, in favor of oxidants, occurs in COPD.

NAC has been reported to reduce the viscosity of sputum in both cystic fibrosis and COPD, facilitating the removal of pulmonary secretions. Moreover, by maintaining the airway clearance, it prevents bacterial stimulation of mucin production and hence mucus hypersecretion.

The superiority of NAC over the other mucolytics may be in its anti-inflammatory and antioxidant properties and its mucolytic actions.

The aim of this study is to evaluate the effects of treatment with NAC long on oxidative stress marker change and also explore the effect of NAC to airway inflammatory, lung function test and CAT scores. Selected oxidative stress marker was defined as 8 - isoprostane, protein carbonyl, DNA damage.


Eligibility Criteria:
Inclusion Criteria:

* Eligible stable COPD patients who are currently treated with only short-acting bronchodilator (salbutamol or fenoterol/ipratropium bromide) or long-acting bronchodilator (LABA or LAMA) or inhaled corticosteroids/LABA
* Pre-bronchodilator FEV1 ≥ 80% and \< 80% predicted
* Current or ex-smokers (≥ 10 pack year)

Exclusion Criteria:

* Concomitant with active and old pulmonary TB, lung cancer, bronchiectasis, lung fibrosis, destroyed lung and other malignancies
* Recent acute coronary syndrome (within 12 weeks)
* Cerebrovascular disease without neurological recovery
* Cognitive impairment
* Recent acute exacerbation of COPD (within 4 weeks)
* Recent respiratory viral infection (within 4 weeks)
* Could not provide adequate sputum specimens
* Develop worsening of COPD symptoms during sputum induction
* Could not provide informed consent
ALIMTA(Pemetrexed)/Cisplatin and ALIMTA(Pemetrexed)/Carboplatin in Extensive Stage Small Cell Lung Cancer.

The purpose of this study is to evaluate the effects (good and bad) of ALIMTA plus Carboplatin or ALIMTA plus Cisplatin on you and your small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of extensive stage small cell lung cancer and can be treated with chemotherapy.
* Have received no prior chemotherapy for your disease.
* Have at least one measurable lesion.
* have an adequate performance status.
* Sign an informed consent form.

Exclusion Criteria:

* Have previously received chemotherapy for your lung cancer.
* Have been treated with a investigational drug within the last 30 days. Have previously completed or withdrawn from this study or any other study investigating ALIMTA.
* Have received radiation therapy within the last 1-2 weeks.
* Have brain metastasis that is uncontrolled.
* Have active infection or other serious condition.
Extension to Study 200952 to Evaluate the Long-term Safety, Tolerability and Pharmacodynamics of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus Subjects

Albiglutide has been developed for the treatment of type 2 diabetes mellitus (T2DM) as an adjunct to diet and exercise, as monotherapy, or in combination with existing therapies and has been approved by the United States (US) Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other regulatory agencies. This is a 26 week, open-label, single group, multicenter, extension study to Study 200952. This extension study will provide extended safety, tolerability and immunogenicity data for the albiglutide liquid drug product. This extension study will comprise 2 study periods: treatment (26 weeks) and post-treatment follow-up (8 weeks). A maximum of 300 subjects will be eligible to take part in this extension study.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have completed the 26 week Treatment Phase of Study 200952
* Male or female
* Able and willing to provide informed consent.

Exclusion Criteria:

* Subject meets one or more of the withdrawal stopping criteria at Visit 1 (Week 26)
Pharmacist Case Finding and Intervention for Vascular Prevention Trial

Heart disease is a common and serious medical condition which causes nearly one in every three deaths worldwide every year.

The factors which increase people's risk for heart disease are well-known, but there needs to be more support given to people to reduce their risk of heart disease. Pharmacists are front line primary healthcare providers who see patients more frequently than any other healthcare provider and can help people reduce their risk of heart disease.

This research project aims to see whether a pharmacist-led intervention can help people reduce their risk of heart disease. The potential impact of this project is to empower people to understand how to reduce their risk of heart disease and reduce the burden of heart disease on the community.


Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years or older)
* Clinical diagnosis of at least one of the following conditions:

  * Diabetes,
  * Chronic kidney disease,
  * Chronic inflammatory condition (e.g., rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gout, systemic lupus erythematosus or psoriasis),
  * Atherosclerotic vascular disease,
  * Hypertension,
  * Obesity (defined as body mass index greater than 30),
  * Current tobacco or vape use

Exclusion Criteria:

* Unwilling to participate/sign consent form;
* Unwilling or unable to participate in regular follow-up visits; or
* Pregnant
Obstructive Sleep Apnea and Comprehensive Remotely-supervised Rehabilitation Program

The purpose of this study is to investigate the feasibility and effect of a 12-week remotely-supervised rehabilitation program in male patients between 25-65 years old with newly diagnosed obstructive sleep apnea with Apnea-Hypopnea Index greater than 15 episodes per hour indicated to CPAP therapy.

The intervention group will undergo comprehensive remotely-supervised rehabilitaiton program in home conditions with teleconsultation (contains telecoaching, telemonitoring) via regular phone calls and e-mails at least 2 times a week. The intervention will include nutrition, health-related lifestyle and behavioral changes recommendations, and at least 5 times a week 30 minutes of moderate-intensity aerobic training, 10 minutes of inspiratory and expiratory muscle training with breathing device and 10 minutes of oropharyngeal exercise along with individually titrated CPAP therapy.

The control group will undergo individually titrated CPAP therapy only. The participants in both groups will go through the following assessments before and after this study: polysomnography, spirometry, anthropometry and body composition examination, laboratory values examination, quality of life questionnaires, Epworth sleepiness scale, 6-min walking test.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* newly diagnosed obstructive sleep apnea
* Apnea-Hypopnea Index greater than 15 episodes/hour
* indicated for CPAP therapy

Exclusion Criteria:

* severe pulmonary hypertension
* severe heart valve disease
* COPD III or IV
* central sleep apnea
* chronic corticosteroid therapy
* long-term oxygen therapy
* heart failure
* left ventricular ejection fraction lower than 40 %
* NYHA III or IV
* cerebrovascular disease
* psychiatric disease
* another type of obstructive sleep apnea treatment
* acute coronary syndrome in anamnesis
Comparison of the Analgesic Effectiveness of Pericapsular Nerve Block and Suprainguinal Fascia Iliac Block Application

Suprainguinal Fascia iliac compartment outlet and Pericapsular nerve reduction, which is a routinely successful method for postoperative analgesia in anesthesia practice; the aim is to investigate information regarding postoperative pain level, analgesic consumption, patient satisfaction and discharge time after arm arthroscopy.

Patients will be monitored with routine monitoring under operating room conditions. After the patient's baseline VAS score and vital signs are recorded, patients will be intubated after induction of general anesthesia. After the site is cleaned, a pericapsular nerve block (PENG) or suprainguinal fascia iliac block (SFIB) will be performed under USG guidance. After the procedure, the patient will be transferred to the surgical team for positioning. Blood pressure and pulse values will be recorded after the procedure and at the 30th minute of surgery.

After the patients wake up, another anesthesiologist in the recovery unit will rate the pain of patients in both groups on a scale of 0-10, using the Visual Analogue Scale (VAS) to describe their pain intensity. Heart rates and noninvasive blood pressures of patients taken to the recovery unit will be measured and recorded. Patient-controlled Analgesia (PCA) will be used for postoperative analgesia for all patients, as is routinely done, and total analgesic consumption will be evaluated. Hemodynamic data, VAS pain scores, and observed hemodynamic data of the patients were examined at 30 minutes, 60 minutes, 90 minutes, 120 minutes, and 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours in the postoperative period. Side effects will be recorded. The evaluation of the pain occurring when the hip is immobilized (VASd) and when it is moved (VASh) will be made by the anesthesiologist with VAS.

Patients' 24-hour postoperative satisfaction will be evaluated. Within the scope of the study, patients' gender, age, height, weight, ASA risk scores and operation times will be recorded.

In the statistical evaluation of the study; Analgesic consumption during the procedure, VAS scores, and analgesic consumption and patient satisfaction in the postoperative period will be evaluated and compared between groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 and under the age of 65 who will undergo hip arthroscopy
* ASA I-II group patients
* Patients without allergies

  * Patients without psychiatric disorders
* Patients without opioid addiction
* Patients who have the ability to use the patient-controlled analgesia (PCA) device and perform VAS scoring
* Patients with no contraindications for peripheral blocks

Exclusion Criteria:

* Patients who do not want to participate in the study
* Patients with uncontrolled hypertension
* Patients with chronic pain or receiving pain treatment,
* Significant Cardiac Disorder (Coronary Artery Disease, Arrhythmia, Electrocardiography Anomaly, Heart Failure, etc.)
* Patients with Diabetes Mellitus
Effect of Osseodensification on the Peri-implant Condition

The goal of this clinical trial is to evaluate the effects of osseodensification vs. traditional implant site preparation clinically , radiographically, bio-chemically. in patients of both sexes, ages 25 to 45, who had bilaterally missed maxillary teeth. The main questions it aims to answer are :which technique was the better results give at implant placement? Researchers will compare Osseodensification maneuver in implant placement to see if implant stability increased also peri-implant tissue accurately formed or the same in traditional implant site preparation. Participants will receiving dental implants in narrow maxillary posterior ridge via small diameter implant in conventional method in first entity while in second entity implant by osseodensification technique using densah bur.


Eligibility Criteria:
Inclusion Criteria:

* All patients were free from any systemic diseases
* Individuals above age of 18 who have thin ridges and missing bilateral maxillary posterior teeth

Exclusion Criteria:

* Severe skeletal discrepancy.
* Para functional habits.
* Patients who had already received or lost implants in the potential implantation site.
* Smoker patients.
The Efficacy of Honey on Improving the Post Surgical Course After Tonsillectomy in Children-prospective Study

The aim of this study is to investigate the effect of honey administration on pain following pediatric tonsillectomy or adenotonsilectomy.

The patients( children 2-18 years old) will divide into two groups by simple randomization method( the control group and the case group).

After surgery the case group: would instructed to use honey twice a day( 5 ml- one tea spoon each time)+acetaminophen syrup+ syrup oxycode( as necessary).

the control group would get as is customary in our ENT department :acetaminophen syrup+ syrup oxycode( as necessary).

The families would ask to follow treatment protocols for 7 days. From the first to the 7th day after the operation , the parents would ask to fill a questionnaire every day for assessment of pain intensity by visual analouge scale(VAS) , the numbers of painkillers taken daily, the number of times the child awaking at night due to pain, the amount of fluids intake daily, the time of commencement of regular oral intake.

patient would follow up 7-14 days after surgery.

This study was approved by the regional ethics committe of the Hospital. The participants would be: Children (2-18 years old, male and female), who will have the indication of tonsillectomy and will undergo classic tonsillectomy with or without adenoidectom in otolaryngology departement in HaEmek Hospital and they ate already honey in their lives.

Exclusion criteria:

* Allergy to honey
* Allergy to Acetaminophen
* Patients with Diabeties mellitus
* pregnent/breast feeding patients
* patients with coagulation disorders
* patients who undrego another operation in addition to tonsillectomy with or without adenoidectomy ( except insertion of ventilation tubes surgery).

Eligibility Criteria:
Inclusion Criteria:

* children ages 2-18 years old that candidates for Tonsillectomy with or without adenoidectomy surgery, in otolaryngolgy department , HaEmek Hospital, Afula.
* Parents' signature on informed consent form.

Exclusion Criteria:

* Allergy to honey
* Allergy to Acetaminophen
* Patients with Diabeties mellitus
* pregnent/breast feeding patients
* patients with coagulation disorders
* patients who undrego another operation in addition to tonsillectomy with or without adenoidectomy ( except insertion of ventilation tubes surgery).
Lung Nodule Imaging Biobank for Radiomics and AI Research

This study will collect retrospective CT scan images and clinical data from participants with incidental lung nodules seen in hospitals across London. The investigators will research whether machine learning can be used to predict which participants will develop lung cancer, to improve early diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Baseline CT thorax imaging reported as having pulmonary nodule(s) between 5 and 30mm in the last 10 years.
* Ground truth known (either scan data showing stability for 2 years (based on diameter) or one year (based on volumetry), complete resolution, or biopsy-proven malignancy.
* Slice thickness \< 2.5mm.

Exclusion Criteria:

* • Absence of at least one technically adequate CT thorax imaging series (defined by visual inspection of presence of imaging data of the thorax in the DICOM record).

  * Slice thickness \> 2.5mm.
  * Imaging \> 10 years old.
  * Ground truth unknown.
Bipolar Sealer Aquamantys Use in Total Knee Replacement

This study will compare the clinical outcomes for patients undergoing a total knee replacement using a bipolar sealer, the Aquamantys® System, as compared to standard electrocautery. Total blood loss during the hospital stay and knee mobility and discharge factors will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥18 years of age
* Patient has failed conservative therapy of osteoarthritis of the knee and has been listed to undergo primary TKA
* Patient is willing and able to provide written informed consent.
* Pre-assessment Haemoglobin ≥ 11.0g/dl
* Patient is suitable to receive spinal anaesthesia with no peripheral nerve blocks
* Patients willing to undergo blood transfusion

Exclusion Criteria:

* Patients that are listed for unicondylar or revision TKA
* Patients who are being converted from a previous high tibial osteotomy and a previous unicondylar knee arthroplasty
* Fixed motor deficit thus affecting functional assessment of the knee
* Patients presenting with a non-osteoarthritis degenerative knee diagnosis
* Patients presenting with known contralateral knee osteoarthritis requiring simultaneous bilateral TKA
* Patients presenting with a history of previous knee infection
* Patients presenting with a pre-operative knee range of motion \< 85°
* Knee deformity greater than 20 degrees varus or valgus
* Patients presenting with a history of bleeding disorders and/or are on chronic blood anticoagulation therapy
* Patients with significantly impaired renal function (defined by EGFR \>30)
* Patients with allergy or sensitivity to non-steroidal anti-inflammatory drugs, ropivacaine, ketoprofen or adrenaline
* Patients presenting with an internal cardiac defibrillator
* Women who are pregnant
* Evidence of active (systemic or local) infection at time of surgery
* Patients who have habitual opioid use
* Patients who have a psychiatric or mental illness which could impair the consent process or ability to complete patient-report questionnaires
* Morbid obesity \[BMI \> 40\]
* Patients who are unwilling to undergo blood transfusion, if necessary
* Patients who are receiving any implant used in conjunction with a customised-cutting block system
* Any patient who cannot or will not provide written informed consent for participation in the study
* Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems
Breath-Actuated Nebulizer Versus Conventional Continuous-Output Nebulizer in Pediatric Asthma Patients

A Breath-Actuated Nebulizer is a newer type of nebulizer device that creates aerosol only when a patient is inhaling, rather than creating aerosol continuously. It is thought that breath-actuated nebulizer devices may deliver asthma rescue medications to patients' lungs more effectively and therefore lead them to recover from asthma attacks faster than conventional continuous-output nebulizer devices. This study compares outcomes including hospital admission rates, number of nebulized treatments required, and patient/family satisfaction when a breath-actuated nebulizer device versus a conventional continuous-output nebulizer is used to deliver asthma medications to pediatric asthma patients in the emergency department.


Eligibility Criteria:
Inclusion Criteria:

* children 1-17 years old with known history of asthma
* children must be presenting to the emergency department for treatment of acute asthma
* children must qualify to be treated for acute asthma according to an existing standardized asthma care algorithm

Exclusion Criteria:

* concomitant chronic respiratory or cardiac disease such as cystic fibrosis, congenital heart disease, or bronchopulmonary dysplasia
* no prior history of asthma
* pregnancy
* reported history of drug allergy to albuterol or ipratropium bromide
* previous participation in the study within the preceding three weeks
* vital sign instability/need for immediate emergency intervention to prevent clinical deterioration
Virtual Reality Biofeedback for Postpartum Anxiety and Depression

The purpose of this study is to test patient feasibility and acceptability of virtual reality biofeedback program in postpartum women for anxiety and depression outcomes.

In an open-label pilot trial, women will undergo a single session using the virtual reality biofeedback program. The objective of this study is to assess feasibility and acceptability of virtual reality biofeedback program in postpartum women with specific assessments of anxiety and depression outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Currently pregnant or postpartum (delivery within 3 months)
* 18 years or older

Exclusion Criteria:

* Unable to participate in study procedures
* English illiterate (surveys validated in English)
Home Outpatient Monitoring and Engagement to Predict HF Exacerbation

The HOME PREDICT HF study looks at new ways to predict hospitalizations for heart failure. We will use a set of devices at home and surveys to collect information about patient's health. This study uses the Eureka app, a new study app developed by the University of California, San Francisco. The study is designed to happen remotely, using this application on a patient's smartphone, so that is as convenient as possible to participate.

HOME PREDICT HF is single center, prospective, unblinded, randomly assigned training and validation observational cohorts to develop machine learning algorithms from an in-home suite of sensors in order to predict 3-month heart failure hospitalization and/or emergency department visits. Study population includes adults presenting with a diagnosis of reduced ejection fraction (LVEF \<= 40%), NYHA class II-IV) who have had a hospitalization for HF in the previous 6 months. The study objectives include (1) To collect observational data from multiple sensors, patient-reported outcomes, and medical record data to develop (train) machine-learning algorithms (2) To validate trained algorithms in a separate validation cohort (3) To collect data to inform the design of a future intervention study. The primary outcome is Ninety-day heart failure hospitalization/emergency department visit for heart failure.

Eligibility Criteria:
Inclusion Criteria:

1. Outpatient and cared for by a PINNACLE Registry practice
2. Age ≥ 18 years old
3. Has a diagnosis of HF in the PINNACLE Registry/Medical Record
4. Seen by PINNACLE practice within the last 12 months
5. Has an LVEF ≤40% on their last data entry (within 1 year) in the PINNACLE Registry
6. NYHA Class II-IV by self-report
7. Has had a hospitalization for HF in the previous 6 months by self-report
8. Owns an Android or iOS smartphone, within Verizon cellular coverage zone in order to allow for data submission.
9. Sleep in the same bed at least 5 days per week
10. Willingness to complete the required surveys, measurements and study activities.

Exclusion Criteria:

1. Home oxygen use
2. Current or planned ventricular assist device
3. Previously or currently on a heart transplant list
4. Chronic dialysis
5. A diagnosis of any cancer and undergoing active treatment
6. In hospice or palliative care
7. Planned surgery/procedure in the next 3 months
8. Planned extended time away from home (\>2 weeks) in the next 3 months
9. Living in a skilled nursing facility or other chronic care facility
10. Pregnancy or planned pregnancy in the next 3 months
11. Inability or unwillingness to consent and/or follow requirements of the study