cyrilzakka/clinical-trials huggingface dataset:
Satisfaction With Nurse Administered Propofol Sedation vs. Midazolam With Fentanyl Sedation for Endoscopy

Sedation for endoscopy is a service more than a necessity. Therefore it should be patient driven. Patients with inflammatory bowel disease (IBD) undergoes life long endoscopic control. Therefore, satisfaction with the procedure experience is paramount for patients with IBD. Investigators wish to study the feasibility and the effect on patient experience of two drugs. Propofol administered by endoscopy nurses (NAPS) and conventional therapy with a combination of fentanyl and midazolam. Investigators hypothesize that patients sedated with propofol has a better procedure experience, that a well performed sedation equals a better experience and that NAPS is as feasible as fentanyl with midazolam sedation.


Eligibility Criteria:
Inclusion Criteria:

* Inflammatory Bowel Disease (IBD) or suspected IBD
* Planned Endoscopy
* Candidate for propofol sedation
* willingness to be randomized
* Ability to complete questionnaire

Exclusion Criteria:

* Allergy to drugs
* American Society of Anesthesiologists Class III
* Body Mass Index \> 35
* Ventricular retention
* Acute condition
* Severe Chronic obstructive pulmonary disease
* Sleep apnea
* Potentially difficult airway or previous difficulty with anesthesia
* Pregnancy
* \<18 years
Comparison of the Effectiveness, Safety, and Satisfaction of Different Methods for Labor Induction

The objective of this interventional study is to compare the effectiveness, safety, and patient satisfaction associated with two commonly used methods of labor induction: low-dose oral misoprostol and the vaginal delivery system with dinoprostone.

The study aims to identify the most suitable induction method for specific subgroups of patients based on parity, body mass index (BMI), age, and cervical ripeness, as well as assess patient preferences for these induction methods.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 37 0/7 and 42 0/7 weeks
* Singleton pregnancy
* Viable fetus in cephalic presentation
* Bishop score ≤ 6
* Maximum parity of three
* Reactive CTG at admission without pathological findings

Exclusion Criteria:

* Age \< 18 years
* Gestational age \< 37 0/7 weeks
* Active labor
* Spontaneous rupture of membranes
* Non-reassuring CTG findings
* Suspected infection (e.g., fever \> 38°C, chorioamnionitis, or unexplained systemic infection)
* Contraindications to vaginal delivery or prostaglandin use
* Previous cesarean delivery or uterine surgery involving entry into the uterine cavity
* Significant fetal abnormalities
* Severe fetal growth restriction with an estimated fetal weight below the 3rd percentile
* Non-Slovenian-speaking participants
Effects of Cognitive Behavioral Therapy (CBT) on Weight Maintenance After Successful Weight Loss

The purpose of this study is to assess the effects of CBT after a successful weight loss by a comprehensive weight loss plan on weight maintenance in obese female adults.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 23-30 kg/ m² who lost at least 10% of her initial weight by the diet plan.
* Must be able to have moderate exercise.
* Must be interested to keep weight loss.

Exclusion Criteria:

* Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.
* Taking medications that could affect metabolism or change body weight.
* Report heart problems, chest pain, and cancer within the last five years.
* Smoking
* Menopause
* Diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.
Fosfomycin I.v. for Treatment of Severely Infected Patients

The purpose of this European, multicentric, prospective, non-interventional study is to document and evaluate the efficacy and safety of the treatment of severely infected patients with intravenously administered fosfomycin, including patients with osteomyelitis, complicated urinary tract infection, nosocomial lower respiratory tract infection, bacterial meningitis/central nervous system infection, bacteraemia/sepsis, skin and soft tissue infection, endocarditis or other infections, each as far as covered by the respective nationally relevant SmPC.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged ≥ 18 years
* Treatment with fosfomycin according to the (national) Summary of Product Characteristics (SmPC) of fosfomycin i.v.
* Patients with osteomyelitis, complicated urinary tract infection, nosocomial lower respiratory tract infection, bacterial meningitis/central nervous system infection, bacteraemia/sepsis, skin and soft tissue infection, endocarditis or other infection, each as far as covered by the respective nationally relevant SmPC
* Written informed consent of the participant (or person in charge in case of patients incapable of giving consent)

Exclusion Criteria:

* Previous documentation of the patient in the present study
* Patients participating in an interventional clinical trial
* Patients with known hypersensitivity to fosfomycin or any of the excipients
* Terminally ill patients
* Patients with "do not resuscitate order"
* Palliative treatment approach
* Failure of \> 3 of the following organ systems: respiratory system, nervous system, cardiovascular system, liver, coagulation, kidney
* Manifest Human Immunodeficiency Virus (HIV) disease (Acquired Immunodeficiency Syndrome, AIDS)
* Fosfomycin treatment as 4th line treatment or at later stage
* Patients with involvement of fungi or mycobacteria in the targeted infection
A Randomized Controlled Trial of a Bone Density Decision Aide

This research study is being conducted to determine if a modified bone mineral density (BMD) test report that contains additional fracture risk information will be a useful physician decision aide in selecting patients for pharmacological osteoporosis therapy. It is hypothesized that this supplementary information, provided in addition to the conventional BMD report, will increase the likelihood that patients at high risk for an osteoporotic fracture will receive prescribed therapy for osteoporosis.

This observational research study is being conducted to determine if a modified bone mineral density (BMD) test report that contains additional fracture risk information will be a useful physician decision aide in selecting patients for pharmacological osteoporosis therapy. It is hypothesized that this supplementary information, provided in addition to the conventional BMD report, will increase the likelihood that patients at high risk for an osteoporotic fracture will receive prescribed therapy for osteoporosis. Physicians who only receive the conventional BMD reports without the supplemental information will be the control group.

To compare the rates of pharmacological interventions for osteoporosis in post-menopausal women, family / primary care physicians are randomized to receive either:(i) a conventional BMD report (absolute bone density, T-score result, Z-score result, qualitative statement indicating the BMD results classification of risk for fracture from osteoporosis according to the World Health Organization (WHO) criteria) versus (ii) a conventional BMD report plus a supplemental information sheet (all the information contained in the conventional BMD report plus five-year estimated risks for future fractures calculated from the physician-supplied clinical risk factors and - for those who have osteoporosis according to the WHO criteria - the number needed to treat (in person years) to prevent one fracture.

Eligibility Criteria:
Inclusion Criteria:

* physicians involved in referring patients for DXA bone density testing

Exclusion Criteria:

* none
New Nasal Applicator / New Formulation - User Study

The purpose of this study is to compare the efficacy of once daily dosing with Rhinocort Aqua (new formulation) against Rhinocort Aqua (current formulation) and placebo in reliving the symptoms of seasonal allergic rhinitis (SAR).


Eligibility Criteria:
Inclusion Criteria:

* In the opinion of the investigator, is a candidate for treatment with nasal steroids based on a history of either a) inadequate control of symptoms with antihistamines, decongestants and/or immunotherapy, or b) prior successful treatment with nasal steroids.
* A documented history of at least one year of seasonal allergic rhinitis.
* A positive response to a skin prick test for grass allergens that must be present in the subject's environment throughout the study.

Exclusion Criteria:

* Primary or secondary adrenal insufficiency
* Nasal candidiasis, rhinitis medicamentosa, acute or chronic sinusitis, influenza, upper respiratory tract infection or structural abnormalities of the nose (e.g., septal deviation, nasal polyps) symptomatic enough to cause significant nasal obstruction as judged by the investigator.
* A diagnosis of asthma requiring treatment as specified in the protocol.
Study of FVIIa Variant BAY86-6150 (B0189) in Subjects With Moderate or Severe Hemophilia Types A or B With or Without Inhibitors

This is the first in humans study of BAY86-6150 (B0189) in non-bleeding subjects with moderate or severe congenital hemophilia A or B with or without inhibitors. This is a randomized, double-blind, placebo-controlled, single-dose, dose escalation study. It is designed to investigate the safety, tolerability, potential immunogenicity, pharmacokinetic and pharmacodynamic profile of BAY86-6150 (B0189) and to determine a dose or range of doses to be examined in subsequent studies.


Eligibility Criteria:
Inclusion Criteria:

* History of moderate or severe congenital hemophilia A or B with or without inhibitors to Factor VIII (FVIII) or Factor IX (FIX)
* Male subjects 18-65 years of age inclusive
* Able to dismiss factor replacement therapy during the course of the study unless required for the treatment of an acute bleeding episode
* Written informed consent
* Willing and able to comply with the requirements of the protocol
* Have adequate venous access
* Willing to use an effective method of contraception until Day 30 of their study participation

Exclusion Criteria:

* Received factor replacement therapy or treatment with any other procoagulant therapeutics, or any antifibrinolytic agents, including blood products, at anytime within 5 days prior to administration of investigational medicinal product (IMP)
* Planned administration of factor replacement therapy or treatment with any other procoagulant therapeutics or any antifibrinolytic agents, including blood products, at anytime during the study period
* Acute bleeding episode or any ongoing bleeding episode at any time within 7 days prior to administration IMP
* Clinically relevant coagulation disorder other than congenital hemophilia A or B
* History of angina or receiving treatment for angina
* History of coronary atherosclerotic disease, disseminated intravascular coagulopathy, or stage 2 hypertension defined as systolic blood pressure (SBP) \>/= 160 mmHg or diastolic blood pressure (DBP) \>/= 90 mmHg
* History of transient ischemic attack, stroke, myocardial infarction, coronary artery disease, congestive heart failure, or thromboembolic event
* Active infection on day of IMP administration or septicemia at any time within 30 days prior to administration of IMP
Endoscopic Treatment of Biliary Strictures After LTX: Balloon Dilatation Versus Stent Placement

Background and Study Aims: Biliary strictures are a major cause of morbidity following liver transplantation with an overall incidence between 10 and 30 %. Up to now biliary strictures were dilated subsequently one to three plastic stents with a diameter of eight to ten F were inserted. In general, stents were exchanged in two to three months intervals over one year. In the present prospective controlled study, efficacy and complication rates of balloon dilation have been compared with dilation plus stenting.

Patients and Methods: XY patients with high-grade biliary strictures (anastomotic and non-anastomotic) were enrolled in this prospective study in random order. X patients were treated by endoscopic balloon dilatation and Y by balloon dilatation plus plastic stent placement in six to eight weeks intervals. The primary end point was permanent opening of the biliary obstruction of 12 months. Number of endoscopic interventions and complications of the procedures were monitored.

Endoscopic treatment was performed by experienced endoscopists who had each performed more than 1000 ERCP procedures. The procedure was performed with the patient under general anesthesia with propofol. A stenosis was considered to be present if the cholangiogram showed strictures with a narrowing of the anastomosis or the proximal donor duct site of the anastomosis and incomplete distal runoff of the contrast agent.

The patients were divided into two groups: 1) balloon dilatation of the stricture, 2) balloon dilatation plus plastic stent placement.

In both groups, endoscopic treatment of the patients comprised sphincterotomy, consecutive dilation of stenosis up to 10 F, removement of occluding material from choledochus duct using a balloon catheter if necessary, and repetitive balloon dilatation of the anastomosis stricture or of the non-anastomotic proximal donor duct stricture to 18 F at the first intervention and to 24 F in the following interventions.

The second group of the patients were additionally treated by large-diameter (10 F) plastic stent placement after balloon dilatation. This procedure was repeated in 6 - 8 weeks intervals in both groups.

Eligibility Criteria:
Inclusion Criteria:

* liver transplanted patients with diagnosis of biliary obstruction based on endoscopic cholangiopancreaticography older than 18 years male and female

Exclusion Criteria:

* patients with multiple organ transplantation
The Effects of Marijuana on Orientation and Motor Coordination and Brain Metabolism in Regular Smokers of Marijuana

This study investigates the effects of 17mg and 13mg Delta THC on orientation and motor coordination and brain metabolic activity in regular users of marijuana. Subjects were tested twice, after smoking cigarettes with marijuana and after smoking cigarettes without marijuana.On both occasions they performed on a virtual reality maze task. They were afterwards scanned in Positron Emission Tomography (PET) with Fluoro-deoxy-glucose (FDG).

This study investigates the effects of 17mg and 13mg Delta THC on orientation and motor coordination and brain metabolic activity in regular users of marijuana. Subjects were tested twice, after smoking cigarettes with marijuana and after smoking cigarettes without marijuana. On both occasions they performed on a virtual reality maze task. They were afterwards scanned in Positron Emission Tomography (PET) with Fluoro-deoxy-glucose (FDG). 12 subjects were tested so far on both conditions.

Eligibility Criteria:
Inclusion Criteria:

* Marijuana dependence
* Age 20-65
* Male and female

Exclusion Criteria:

* Pregnant women
* Dependence on other substances
* Psychiatric diagnosis apart from marijuana dependence
* Neurological disorder
* Young persons
A Patient Education Video Program for Post-Operative Recovery After Upper Extremity Surgery

Adult patients undergoing elective outpatient, upper extremity, orthopedic surgeries will be randomized to view one of two educational programs: 1) a 2-video series regarding post-operative pain management or 2) a video regarding wound care and activity. The effect of this educational program on pain medications used, pain control efficacy, and other measures of satisfaction and recovery will be assessed.

Four hundred (400) adult patients undergoing elective outpatient, upper extremity, orthopedic surgeries will be recruited by the surgeon-investigators. Patients will be randomized to view one of two educational programs: 1) a 2-video series regarding post-operative pain management or 2) a video regarding wound care and activity.

These patients will be encouraged to review the video online in the week before surgery. An intake enrollment form will be completed by an investigator using demographic information available in the chart.

Participants in both arms will complete their Patient Education Study Diary daily, for 7 days following their surgery. There are two versions of this diary: the Wound Education Version asks patients to report daily pain mediation use. The Pain Education Version does not include this section as patients in the pain management arm of the study record this information in their Recovery Diary.

The patient will be contacted again by phone and/or mail 1 year after surgery (12-14 months) using the contact information available in EPIC to determine the self-reported prevalence of chronic pain and pain medication use.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients planning elective outpatient orthopedic surgery procedures by a Carilion Clinic hand surgeon will be eligible for the study.

Exclusion Criteria:

1. Patients unable or unwilling to provide informed consent
2. Patients unable to unwilling to participate in the trial (poor English language skills, blindness, cognitively disadvantaged, poor literacy skills, other barriers to participation)
3. Patients who are or suspect they may be pregnant.
4. Patients for whom the medical provider, in his professional judgment, does not feel that the study protocol would be appropriate. (to be tracked)
Post-Market CorPath Registry on the CorPath 200 System in Percutaneous Coronary Interventions

To collect data on the routine patterns of use, safety and effectiveness, including the clinical and technical performance of the CorPath 200 System, in the delivery and manipulation of coronary guidewires and stent/balloon catheters during PCI procedures.

This is a prospective, single-arm, open-label, multi-center patient registry of the CorPath 200 System to examine its performance during PCI procedure and patient outcomes through 72 hours post-procedure or hospital discharge, whichever occurs first.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years.
2. Patients with coronary artery disease undergoing Percutaneous Coronary Intervention (PCI) with the CorPath 200 system.
3. The subject or the legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

1. Concurrent enrollment in another device or drug study protocol that specifically excludes concurrent enrollment or that prevents collection of data required in this registry (concurrent participation in another registry is not an automatic exclusion criterion for this study).
2. Failure/inability/unwillingness to provide informed consent.
Comprehensibility of Colorectal Cancer Screening Educational Materials: Effects on Patient Knowledge and Motivation

The purpose of this study is to determine whether a newly developed patient education document concerning colorectal cancer screening will be better understood and have greater effects on patient knowledge of and motivation for screening than a standard educational document.


Eligibility Criteria:
Inclusion Criteria:

* Receive primary care at one of the participating outpatient offices
* Age 50-75
* Able to read and speak English
* Adequate vision, hearing, and hand function to read printed documents, communicate with research staff, answer questionnaires, and otherwise participate
* Not up to date for colorectal cancer screening (defined as fecal occult blood test within 1 year, flexible sigmoidoscopy within 5 years, or colonoscopy within 10 years)
The Train Study: Parental Understanding of Informed Consent

Project Summary: One of the challenges facing pediatric researchers is the need to balance decreasing funding with the time and human resource costs associated with enrolling children. In order to address this, the Emergency Department (ED) research team developed an innovative model for subject enrollment and consent using highly trained and supervised undergraduate students. From a human resources perspective, utilizing students is more cost effective than the traditional research nurse model. However, a concern with this method is the adequacy of parental understanding of study information for informed consent. The aim of this project is to determine if the use of students is at least as good as the more costly "gold standard" of experienced research nurses. The validation of this innovative student model will enable child health investigators to better meet parent's needs and increase the efficiency of pediatric research.

The primary objective of this study is to measure parental comprehension of informed consent information using an innovative undergraduate research assistant program compared to consent using the traditional research nurse model. We hypothesize that parental comprehension of the informed consent information process when approached by undergraduate students will be comparable (or not worse) than when consent is obtained by a research nurse.


Eligibility Criteria:
Inclusion Criteria:

* Parent's child must be eligible for an interventional study in the Alberta Children's Hospital Emergency Department
* Parent or accompanying adult must be the legal guardian
* One independent trained research student and one research nurse must be available for randomization
* Parent must be exposed to entire informed consent process

Exclusion Criteria:

* Previous participant in the TRAIN study
* Parental language barrier
Pilot Study on The Effectiveness of Relative Motion Orthosis in Finger Motion

The purpose of this feasibility pilot study is to determine the effectiveness of Relative Motion Orthosis (RMO) in regaining finger range of motion compared to standard care in patients diagnosed with Proximal Interphalangeal (PIP) stiffness with an extension lag secondary to finger injury. Participants will be enrolled and randomized into groups receiving either standard conservative interventions or standard interventions in addition to the RMO. The primary endpoint is to evaluate the efficacy of relative motion orthosis in PIP ROM using clinical scoring and physical exam findings.


Eligibility Criteria:
Inclusion Criteria:

* Age range 18-80
* Any gender
* Any Proximal Interphalangeal (PIP) injury that causes reduced PIP Active Range of Motion (AROM) in extension
* Right or left hand injury
* Level of Chronicity (4 weeks - 6 months)
* Able to follow instructions

Exclusion Criteria:

* PIP with hard end feel (feels they need serial casting) - level of chronicity
* Any digital nerve injury / skin laceration that can prevent the patient from using the orthosis
* Severe arthropathy
* Literacy deficits: patients need to be able to follow verbal and written instructions independently to minimize risks and improve outcomes from care.