cyrilzakka/clinical-trials huggingface dataset:
Preventing Diabetes in Those at Risk by Having a Facilitator and Family Doctor Encourage Healthy Activity and Eating Habits

Nearly six million Canadians are living with an increased risk of diabetes (prediabetes) and approximately 50% of these will develop type 2 diabetes within five years. The investigators wish to help these people change their lifestyle, to prevent them from getting diabetes. Trials have shown that by supporting people with prediabetes to be more active and have healthier eating habits they can halve their risk. However, these interventions were very costly and not performed in Canada. With the help of local Family Physicians and other health professionals (e.g. physiotherapy, psychology, endocrinology, nursing) the investigators have created a less expensive intervention suitable for the Canadian population and health system. The investigators need to perform a study to see whether these modified approaches are practical for Canadians and likely to be effective. People at risk will be invited to participate from family practices that have helped us in the initial stages of this program. Family practices will be randomized to giving either the study intervention or continue with the physician's usual care. People receiving the intervention will have an appointment with their family doctor to discuss their exercise and eating habits and agree changes that are necessary. A prescription detailing these changes will be completed and signed by the family physician and participant. Participants will be given the name of a lifestyle change facilitator (LCF) who will receive a copy of the prescription and contact the participant to help them set achievable goals. The LCF will contact participants once a month for six months to help them achieve these goals. The investigators eventual aim is to test this intervention in a large-scale randomized control trial. To achieve this it is necessary to pilot all aspects of the trial. Information from the pilot study can then be used to design and perform a large-scale study effectively. The investigators hope that eventually the numbers of Canadians progressing to having diabetes will be reduced.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥ 18 years
* HbA1c of 5.7 to 6.4% and/or FPG of 6.1 to 6.9 mmol/l and/or a 2hr 75g OGTT of between 7.8 and 11.0 mmol/l

Exclusion Criteria:

* People with Type I or II diabetes
* Unstable angina
* Uncontrolled congestive heart failure
* Unstable arrhythmia
* Heart valvular disease
* Severe hypertension (systolic ≥ 200 or diastolic ≥ 120)
* Pregnant women or planning pregnancy within two years
* Life expectancy \< 1 year
* Waiting for major surgery
* High risk of fracture
* Pregnancy or planning pregnancy
FOCUS-CI: A Preventive Intervention With Children and Families of the Combat Injured

The purpose of this study is to implement a unique evidence-based intervention program to help military families deal with the critical issue of combat injury and its impact on current and future family health and functioning. The study is a randomized study. The study will compare the effects of the newly designed FOCUS-CI (Families OverComing Under Stress - Combat Injury) with the existing standard of care (SoC) at three military medical rehabilitation sites (Walter Reed Amry Medical Center, Brooke Army Medical Center and Madigan Army Medical Center) on key aspects of family health and functioning.

Injured service members who have at least one child between the ages of 5 and 18 years who have sustained a combat injury severe enough to require at least two weeks of inpatient hospitalization and who are within 6 months of discharge from inpatient hospitalization and currently receiving outpatient care will be recruited into this study.

Eligibility Criteria:
Inclusion Criteria:

For a family to be eligible for the study, the injured service member must:

* have sustained a combat injury that was severe enough to require a minimum of two weeks inpatient hospitalization immediately after the injury;
* currently be participating in outpatient rehabilitation for the same combat injury;
* must be within 6 months of discharge from inpatient hospitalization at the start of the intervention;
* families must have at least one child between the ages of 5 and 18 and be fluent in English. English fluency will be determined by asking, "Is English spoken in your home?"
* pregnant women are eligible to participate.

Exclusion Criteria:

* families in which the service member did not sustain a qualifying injury or has been discharged from inpatient care for more than six months will not be eligible to participate
* families in which a member is actively psychotic
* families in which a service member's primary relationship is with a "significant other" who is not eligible for military medical care
* due to the limited ability of young children to comprehend the intervention activities, children under the age of 5 years will not be invited to participate in the intervention.
* no one will be excluded based on race, ethnicity, gender, pregnancy, medical status, or cognitive functioning.
Sex Differences in Vascular Responses to Exercise

A key early event in cardiovascular disease development is endothelial dysfunction, characterized by impaired flow-mediated dilation. Regular aerobic exercise ameliorates endothelial dysfunction in healthy older men, but the data in healthy postmenopausal women are inconsistent with many studies showing no effect. The primary objective of this study was to examine sex differences in acute and chronic endothelial responses to exercise training in older men vs. older postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* adults able to give consent
* men and women
* women must be postmenopausal (either natural or surgical)
* 60 to 79 years of age

Exclusion Criteria:

* any relevant cardiovascular diseases (e.g., history of coronary artery bypass surgery or angioplasty, or heart failure, myocardial infarction, angina pectoris, peripheral arterial disease)
* myocardial ischemia during maximal graded exercise test
* major chronic clinical disease (e.g., diabetes, renal or hepatic disease or infection with hepatitis B, C, or HIV)
* seizures, or other relevant on-going or recurrent illness
* recent (within 3 months) or recurrent hospitalizations
* systolic blood pressure \< 100 mmHg
* body mass index \> 35 kg/m\^2
* \>5% weight change in past 3 months or unwilling to remain weight stable during study participation
* use of tobacco products including smoking traditional or e-cigarettes
* use of hormone replacement therapy in women or men (e.g., estrogen, progesterone or testosterone)
* regular aerobic exercise training (≥30 min/session and ≥ 3 days/week)
sIPOM vs pIPOM in Incisional Hernia Patients

Nowadays, two intraperitoneal mesh approaches are commonly used in Laparoscopic Ventral Hernia Repair (LVHR): the simple intraperitoneal onlay mesh repair (sIPOM) and the intraperitoneal onlay mesh reinforcement with defect closure before placement of mesh (pIPOM). The pIPOM has been introduced to reduce adverse events in incisional hernia (IH) surgery (i.e., seroma formation, recurrences etc ) associated to laparoscopic hernia repair, and satisfactory outcomes has been reported in several studies. In details, sequelae such mesh bulging seems to be less associated to pIPOM than sIPOM, even if the latter topic is matter of intense debate. The pIPOM has been introduced in the guidelines for the laparoscopic treatment of ventral and incisional abdominal wall hernias published by the International Endohernia Society (IEHS) in 2014. Despite prospective studies on the quality of IPOM-Plus are available, the evidence level for the statements in these guidelines remains low. The aim of this prospective analysis is to compare the postoperative outcomes of patients treated for Incisional hernia (IH) with sIPOM and pIPOM after 36 months follow-up in terms of recurrence and wound events.


Eligibility Criteria:
Inclusion Criteria:

* Incisional Hernia whit length \>3 and \<12 in width or length (Medium size according to European Hernia Society classification incisional hernias
* Body mass index (BMI) \< 35 kg/m2
* Elective surgery setting
* Clean wound field according to the Centre for Disease Control and Prevention (CDC) wound classification (Grade I)

Exclusion Criteria:

* Incisional hernia \<3 or \>12 cm
* Abdominal aortic aneurysm disorders
* Pregnancy or lactation
* Psychiatric illness
* Multifocal hernia defect
* Life expectancy\<2 years
* Inflammatory bowel disease
* emergency setting
Kinematic Biofeedback on Gait Quality in Stroke

Walking disorder is the most common and concerning issue for individuals with stroke. Previous studies have often used improvements in walking speed and distance as reference indicators for the advancement of gait performance in individuals with stroke. However, for individuals with chronic stroke, considering gait symmetry and variability to enhance gait quality as the primary intervention target may be more crucial. According to a literature review, it can be inferred that the application of biofeedback to detect gait quality may be an effective approach to improve gait symmetry and variability in individuals with stroke. However, there is still insufficient research evidence on this issue. Therefore, this study aims to investigate the effects of a kinematic biofeedback device system, which detects hip joint angles, on gait quality in individuals with chronic stroke.


Eligibility Criteria:
Inclusion Criteria:

* First stroke
* Stroke onset time ≥ 6 months
* Functional Ambulation Category ≥3
* Passive range of motion of affected hip extension is at least 10 degrees
* Mini-Mental State Measurement score ≥ 24 points

Exclusion Criteria:

* Modified Ashworth Scale of affected ankle plantar flexors ≥ 2
* Muscle strength of affected ankle plantar flexors via Manual Muscle Testing ≤ 1
* Uncorrected auditory impairment
* Severe cardiovascular disease or uncontrolled hypertension
* Other orthopedic diseases that may affect walking ability
* Other neurological disease except stroke
Effect of Repeated Feedback to Registered Nurses Pain Nursing Documentation

The aim of the study is to find out how pain nursing documentation audit and educational feedback effect to RN's pain nursing documentation, the average level of pain nursing documentation knowledge of unit RN's, patient satisfaction of pain management and number of pain nursing incident reports. In addition, how background variables are related to the pain nursing documentation.

Research hypothesis:

Pain nursing documentation audit and educational feedback increased RNs' pain nursing documentation and knowledge, patient satisfaction to pain management and effect to number of pain nursing incident reports.


Eligibility Criteria:
Inclusion Criteria:

* Registered nurses (RN) who work at the Kuopio University Hospital in units of which patients potentially require pain management.

Exclusion Criteria:

* Professionals other than RN
* RN who do not use pain management strategies in their work
Hepatic Fibrosis Non-invasive Methods Questionnaire

Due to the limitations and the invasive nature of liver biopsy, there has been extensive interest in developing non-invasive tests to measure liver fibrosis (1). These are alternatives to liver biopsy that can be used in clinical practice, with benefits in terms of cost, risk, and patient convenience (2). Clinically applicable non-invasive tests include radiological studies, transient elastography (TE), and serum markers. We aim at studying acceptability, reliability, applicability and practical aspects of invasive and noninvasive methods for assessment of hepatic fibrosis and cirrhosis among hepatologists.

Due to the limitations and the invasive nature of liver biopsy, there has been extensive interest in developing non-invasive tests to measure liver fibrosis (1). These are alternatives to liver biopsy that can be used in clinical practice, with benefits in terms of cost, risk, and patient convenience (2). Clinically applicable non-invasive tests include radiological studies, transient elastography (TE), and serum markers. We aim at studying acceptability, reliability, applicability and practical aspects of invasive and noninvasive methods for assessment of hepatic fibrosis and cirrhosis among hepatologists.

Methods:

The study is a survey study among hepatologists. Four thousand hepatologists will be invited to participate in the questionnaire through e-mail invitations to answer 50 questions of the questionnaire. The questionnaire will be hosted on Survey monkey website and results will be analyzed to get the consensus opinion of participants for the use of invasive and non-invasive methods for assessment of hepatic fibrosis and cirrhosis and factors affecting their preferences.

Statistical analysis plan Analysis of data will be performed using Statistical Package for Scientific Studies 17 for Windows. Description of qualitative variables will be in the form of numbers (No.) and percent (%). Description of quantitative variables will be in the form of mean, standard deviation (SD). Questionnaire results will be compared against different baseline characteristics of the studied group. According to the type and distribution of data, suitable tests for inferential statistics will be used. Significance of the results will be presented in the form of P-value.

Eligibility Criteria:
Inclusion Criteria:

* hepatologists

Exclusion Criteria:

* Non hepatologists
Effect of Exenatide on Glucose Homeostasis Determinants in Type 2 Diabetes

The purpose of this study is to determine in type 2 diabetic patients in secondary failure to combined oral therapy whether, besides improvement in glycemic control, addition of exenatide, a new drug introduced to treat diabetes before addition of insulin to current therapy, over 6 months is associated with improvement in beta-cell function, insulin sensitivity following 24-hours discontinuation of the drug.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes subjects
* 40 to 80 years
* body mass index (BMI) between 25 and 40 kg/m²
* baseline glycated haemoglobin (HbA1c) \> 7.0 %, despite a maximally-tolerated combined oral therapy with a BCF stimulant (sulfonylurea or repaglinide) plus metformin

Exclusion Criteria:

* previous or current use of glitazone
* previous use of systemic glucocorticoids, weight-reducing drug(s) such as sibutramine
* previous exposure to GLP-1 receptor agonist or DPP-4 inhibitors
Placebo Controlled Dose-Response Study of Rivoglitazone in Type 2 Diabetes

The purpose of this study is to assess the efficacy response of rivoglitazone HCl on the change in HbA1c after 12 weeks of treatment in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes mellitus
* HbA1c \>6.5% and \<10%
* FPG \>126 mg/dL (7mmol/L) and \<270 mg/dL (15 mmol/L)

Exclusion Criteria:

* history of type 1 diabetes
* history of ketoacidosis
* current insulin therapy
* C-peptide \<0.5ng/mL
* impaired hepatic function
* CHF or history of CHF (NYHA stage I - IV)
* uncontrolled hypertension
Precision Pain Management for Major Abdominal Surgery in Colorectal Surgery

The primary objectives of this study are to evaluate the potential for preoperative pharmacogenomics (PGx) testing to positively influence postoperative opioid use through visual analog scale (VAS) guided administration of narcotic equivalent and lower pain scores as measured by OBAS in patients undergoing major abdominal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subject capable of giving consent
* Age 18-80
* Scheduled for open colorectal resection at Cleveland Clinic main campus (with preoperative appointment scheduled at least five days before date of surgery)

Exclusion Criteria:

* Patient does not speak English
* Patient with substance-use disorder (including alcohol)
* Patient diagnosed with major depression
* Patient currently taking opioids
* Previous long-term opioid use (\> 3 months)
* Previous opioid use with a dose of \>100 milligram morphine equivalent (MME)
* Patient has pain-related disorder (e.g. fibromyalgia, sympathetic dystrophy, etc.)
* Documented allergy to pain medication
The Effect of Pecha Kucha Presentation for Basic Life Support Training on Students' Knowledge and Practices Levels

Basic Life Support (BLS) is the practice performed to ensure oxygenation of the lungs and pumping of blood from the heart without medication or medical intervention in a person whose breathing and/or heart has stopped (Tiryaki and Doğu, 2018). In the vast majority of out-of-hospital cardiac arrest cases, the chance of survival is very low. Therefore, early, accurate and effective first aid application is vital (Shahrakivahed et al. 2015). The low survival rates after cardiac arrest indicate that basic life support skills still need to be developed and proficiency maintained during cardiopulmonary resuscitation (CPR) (Everett-Thomas et al. 2016).

Nowadays, with technological developments, the use of new presentation techniques in addition to the methods used to develop knowledge, skills and practices in health sciences education is becoming increasingly widespread .Pecha kucha (PK) is an innovative form of presentation used around the world. PK, derived from the Japanese word meaning "chat", helps present creative works with visual images. Pecha kucha is a compact and effective presentation method consisting of 20 slides, each presented in 20 seconds This "20×20" format, which requires careful editing and develops the use of critical communication skills, serves as an innovative and valuable tool that allows the presenter to dynamically and systematically present important information worth sharing to the audience. Thanks to Pecha Kucha, the presenter conveys the topic quickly and clearly without deviating from the essence of the topic. PK may be superior to traditional PowerPoint presentations in terms of learning function. PK is as effective as traditional PowerPoint presentations in retaining information. It is stated that with the pecha kucha method, information can be presented in a more concise way, without any difference in quality, compared to a longer PowerPoint presentation. PK presentation, including visual and narrative presentation, does not take more than 7-8 minutes. It is stated that teachers and students prefer this technique due to its good presentation quality, increased eye contact and visual appeal, and attractiveness. In the literature, there is a lack of studies examining the knowledge and application skills of students regarding BLS education given using the Pecha Kucha method. In addition to contributing to the existing literature, this research will also contribute to determining the effect of basic life support training given with Pecha Kucha, a current presentation technique, on the learning and practice level of students studying in the field of health services.

Eligibility Criteria:
Inclusion Criteria:

* Having a stoma for the first time,
* Able to speak and understand Turkish,

Exclusion Criteria:

* Having previously had a stoma,
* Having difficulty speaking and understanding Turkish
Tislelizumab Plus TP as Neoadjuvant Therapy for Local Advanced Cervical Carcinoma

The goal of this clinical trail is to investigate the efficacy and safety of PD-1 antibody Tislelizumab plus TP regimen (taxane combined with platinum) as neoadjuvant therapy for patients diagnosed as local advanced cervical carcinoma (FIGO staging IB2-IIB).

This phase I study is being conducted to establish efficacy and safety of Tislelizumab plus TP regimen (taxane combined with platinum) as neoadjuvant therapy for patients diagnosed as local advanced cervical carcinoma (FIGO staging IB2-IIB).

All enrolled patients will receive same intervention. Treatment naïve patients who are diagnosed as local advanced cervical squamous cell carcinoma will receive Tislelizumab plus TP regimen before surgery for 3 cycles. After treatment, radiographic evaluation will be performed to assess clinical efficacy. Patients who have objective response will undergo radical surgery. Patients who are disease stable or progression will undergo radical chemoradiotherapy. The primary endpoint is major pathological response rate (MPR).

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed cervical squamous cell carcinoma.
2. Clinical staging FIGO IB2-IIB, treatment naive.
3. Female patients aged≥18 years.
4. ECOG performance status 0 or 1, expected lifetime≥3 months.
5. Adequate organ function: Absolute neutrophil count (ANC) ≥1.5x109/L, White blood count ≥3.5x109/L, Platelets ≥75x109/L, Hemoglobin (Hb) ≥90g/L, ALT/AST ≤2.5x ULN, Serum bilirubin ≤1.5x ULN, Serum creatinine ≤1.5x ULN.
6. HBV infected patients (inactive/asymptomatic carrier, chronic or active) with HBV DNA\<500IU/ml (or 2500 copies/ml).
7. Pregnancy test of female patients with fertile activity should be negative within 7 days before enrollment. Patients should keep contraception during treatment.
8. Willingness and ability to comply with the protocol for the duration of the study including scheduled visits, examinations, investigations and treatment plans with informed consent form.

Exclusion Criteria:

1. Pregnancy or children bearing potential.
2. brain or meningeal metastasis.
3. With second primary malignant diseases.
4. With uncontrolled auto-immune diseases, interstitial pneumonia, ulcerative colitis, or patients who should receive long-term glucocorticoid treatment (\>10mg/d prednisone).
5. With uncontrollable complications
6. Inadequate organ function
7. Known hypersensitivity reaction to any of the study drugs or components.

9. Other unsuitable conditions determined by investigators.