cyrilzakka/clinical-trials huggingface dataset:
The Effect of Continuous Glucose Monitoring in Surgical Patients with Diabetes.

The goal of this randomised controlled trial to investigate the effect of continuous glucose monitoring (CGM) compared to standard point-of-care (POC) blood glucose measurements in surgical patients with diabetes in patients.

The main question it aims to answer is:

• Can the use of the CGM device Dexcom G7 with real-time alerts on dysglycaemia increase the time in range for glucose levels as compared with standard monitoring with point-of-care blood glucose in surgical patients with diabetes?

Participants will be asked to wear a CGM device (Dexcom G7, Dexcom Inc.) during their stay in the hospital. For patients in the intervention group, deviations of glucose levels will provide the nursing staff with alerts. All patients will receive standard care of their diabetes. The CGM device will be worn for up to 10 days or until discharge.

This is a prospective randomised controlled multicentre trial on patients living with diabetes who undergo surgery at Rigshospitalet, Copenhagen University, Bispebjerg and Frederiksberg Hospital, Copenhagen University, and Zealand University Hospital, Køge, Denmark

The study aims to investigate the effect of the CGM-device Dexcom G7 CGM in patients with diabetes undergoing surgery on the diabetic control. The Dexcom G7 provides glucose readings every 5 minutes and can send alerts on dysglycaemia (hypo- and hyperglycaemia) to mobile devices held by the nursing staff.

Patients will wear the CGM before, during and up to 10 days postoperatively.

The study will include 200 patients.

This study is part of an overall project that aims to investigate the use of CGM and continuous wireless monitoring of vital signs in patients with diabetes undergoing major surgery. Using this technology, postoperative complications including dysglycaemia can potentially be detected and treated earlier thus improving the perioperative care.

Eligibility Criteria:
Inclusion Criteria:

* Medical history with diabetes mellitus (DM1 or DM2 (insulin-dependent and non-insulin-dependent) requiring antidiabetic drug(s)
* Acute or elective abdominal, orthopaedic, urological, or vascular surgery with estimated duration of surgery \>45 minutes
* Expected stay for at least one night in the hospital postoperatively

Exclusion Criteria:

* Local skin symptoms including infection at the posterior aspect of the upper arm that does not allow the sensor to be placed on an unaffected skin area
* Known allergy to the equipment plaster
* Known pregnancy
* Patients with pacemaker or implantable cardioverter defibrillator (ICD) device
* Previous or currently scheduled for pancreatectomy (complete or partial)
* Patients receiving hydroxyurea (these drugs may interfere with CGM readings)
Perceived Barriers of Cervical Cancer Screening in Reunion Island and Key Levers for Improvment

FOSFORE study aims at identifying the barriers of cervical cancer screening in Reunion Island and key levers for improvment.

FOSFORE is a cross sectional KABP (Knowledge, Attitudes, Beliefs and Practices) telephone survey on cervical cancer screening from a sounding board of women aged between 25 and 65 years and living in Reunion Island.

Sample size was estimated from local datas on cervical cancer screening.

Eligibility Criteria:
Inclusion Criteria:

* Women aged between 25 and 65 yo
* living in Reunion Island
* speaking French, Creole or Shimaore language
* able to answer phone

Exclusion Criteria:

* history of hysterectomy
* history of incomplete or total conisation
Osteopathy Treatment and Cardiovascular Recovery After a Rugby Match

The purpose of this study was to explore the efficacy of osteopathic manipulative treatment (OMT), a form of non-invasive manual treatment, for a faster recovery of cardiovascular parameters after a rugby union match in professional male athletes. To this end, the effects of OMT on resting cardiovascular function and cardiovascular reactivity were evaluated in twenty-three male players 18-20 hours after a match and compared with a corresponding no-match (control) condition. Assessment of resting cardiovascular parameters 18-20 hours after a match revealed the presence of elevated mean arterial pressure and heart rate, and reduced vagally-mediated heart rate variability compared with a no-match condition. OMT provoked a significant reduction in mean arterial pressure and increased vagally-mediated heart rate variability at rest both in the after match and control conditions. Moreover, OMT favoured a larger vagal withdrawal in response to an orthostatic stress compared with a sham treatment. These results suggest that OMT may be implemented as a recovery strategy to restore athletes' cardiovascular homeostasis after a rugby union match.

The presence of cardiovascular autonomic alterations in the aftermath of an intense exercise performed during a competitive match may indicate incomplete recovery and prolonged fatigue.Therefore, the implementation of effective interventions aimed at favoring a faster recovery of athletes' cardiovascular homeostasis in the aftermath of a competitive match may be beneficial for greater adaptations to subsequent training and enhanced overall performance. In this regard, osteopathic manipulative treatment (OMT) is a form of non-invasive manual treatment that uses a set of touch, manipulation and mobilization procedures to diagnose, treat, and prevent illness or injury. In the present study, the investigators sought to explore the efficacy of a single session of OMT in restoring alterations in cardiovascular parameters at rest and in response to an orthostatic challenge in trained adult male athletes long after (18-20 hours) a rugby union match.

Eligibility Criteria:
Inclusion Criteria:

* being healthy and injury-free
* age ≥ 18 years old
* being Caucasian
* regular participation in competitive matches of rugby union consisting of 2, 40-min halves
* regular training for an average of six hours/week during the last four weeks

Exclusion Criteria:

* history of cardiovascular disease or traumatic brain injury
* chronic drug treatment
* use of any medications during the last week
* having received osteopathic manipulative treatment before
Episodic Future Thinking and Compassion

During the COVID-19 (Coronavirus Disease 2019) pandemic, public health departments have issued guidelines to limit viral transmission. In this environment, people will feel urges to engage in activities that violate these guidelines, but research on guideline adherence has been reliant on surveys asking people to self-report their typical behaviour, which may fail to capture these urges as they unfold. Guideline adherence could be improved through behaviour change interventions, but considering the wide range of behaviours that COVID-19 guidelines prescribe, there are few methods that allow observing changes of aggregate guideline adherence in the 'wild'. In order to administer interventions and to obtain contemporaneous data on a wide range of behaviours, the researchers use ecological momentary assessment. In this preregistered parallel randomised trial, 95 participants aged 18-65 from the United Kingdom were assigned to three conditions using blinded block randomisation, and engage in episodic future thinking (n = 33), compassion exercises (n = 31), or a sham procedure (n = 31) and report regularly on the intensity of their occurrent urges (min. 1, max. 10) and their ability to control them. The researchers investigate whether state impulsivity and vaccine attitudes predict guideline adherence, while assessing through which mechanism these predictors affect behaviour.


Eligibility Criteria:
Inclusion Criteria:

* Resides in the United Kingdom
* Fluent in English
* Must pass attention check in eligibility survey

Exclusion Criteria:

* Less than 50% compliance with ecological momentary assessment surveys
Ticagrelor China Pharmacokinetic/Pharmacodynamic Study

open label, single centre, randomised, Phase IV, pharmacokinetic, pharmacodynamic, and safety study to evaluate single and multiple doses of 45, 60, and 90 mg of ticagrelor in Chinese patients with stable coronary heart disease

Up to 36 patients will be randomized in order to ensure 10 patients per treatment are evaluable.Ticagrelor will be supplied as 45 mg, 60mg, and 90mg tablets. Following an 8 hour fast on single dose on Day 1 and Day 7; on multiple doses from Day 3 to Day 6. Prior to the first dose of study drug there will be a screening period of maximum of 19 days. Patients will report to the clinical pharmacology unit (CPU) on Day -2 and will remain confined there until completion of study procedures on Day 7, the patients will be discharged on Day 8. In addition, patients will return to the CPU for a follow up visit 2 to 5 days after the last dose. Each patients participation, including the screening period, will take approximately 33 days.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated written informed consent prior to any study specific procedures.
2. Female or male Chinese (as defined by Chinese Regulatory) patients aged 18 years or older with suitable veins for cannulations or repeated venipunctures.
3. Documented stable coronary heart disease (CHD) fulfilling all of the following, and taking 75-100 mg ASA daily treatment:

   Diagnosed stable angina pectoris per the guidance of Chinese Society of Cardiology published in 2007, patients with angina severity classified as I and II of Canadian Cardiovascular Society grading of angina pectoris.
4. Female patients without pregnant potential

Exclusion Criteria:

1. Any indication for oral anticoagulant or dual antiplatelet treatment and chronic ASA with doses greater than 100 mg/day.
2. Concomitant therapy with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic index, or strong CYP3A inducers within 14 days preceding the first dose of study medication and during study treatment.
3. Increased bleeding risk.
4. Contraindication or other reason that ASA or ticagrelor should not be administered
5. Patients that are scheduled for revascularization (eg, PCI, CABG) during the study period
Multicentre Study on Diabetic Foot Treatment

With a rapidly growing incidence rate and a high disability rate,The Diabetic Foot has long been difficult to treatment, which has caused a huge burden to patients and society. The blood supply disorder is one of the main reasons that lead to the morbidity and difficulty in healing of diabetes feet, but there is still a lack of particularly effective treatment to improve the blood supply of diabetes feet. Both transverse bone transport and bone marrow cell transplantation have shown some clinical effects. However, the difference in efficacy between the two has not been reported. In this study, investigators compared the therapeutic effects of these two methods on the healing of diabetes foot ulcers through a controlled clinical study.

In this study, investigators compared the therapeutic effects of Tibial Transportation Combined With Autologous mesenchymal stem cells Local Infusion on the healing of diabetes foot ulcers through a controlled clinical study.

Eligibility Criteria:
Inclusion Criteria:

* Symptoms: Wagner stage 2 or above foot ulcer (deep ulcer, abscess or osteomyelitis; localized gangrene, characterized by ischemic gangrene, usually with neuropathy; gangrene of the whole foot), may be accompanied by chronic limb pain, intermittent claudication, cold sensation, abnormal skin sensation and other symptoms
* Have not taken reserpine in the past week or can change to other antihypertensive drugs
* Voluntary participation and signing of informed consent

Exclusion Criteria:

* Patients with organ failure diagnosed by doctors in the past: such as heart failure, liver and kidney failure
* Patients with myocardial infarction diagnosed by doctors in the past
* With congenital or acquired organic heart disease
* With basic disease is in the active stage, such as newly diagnosed leukemia patients, or leukemia patients with relapse and refractory
* Active infection: pulmonary infection, intestinal infection and other existing infections
* Severe anemia
* Severe osteoporosis
* Have undergone amputation of both lower limbs
* The investigator judged that it was not suitable to participate in this study, including the existence of abnormal laboratory test results or clinical abnormal symptoms/signs
* There are any of the following conditions that may limit the patient's compliance or hinder data collection: dementia; Serious mental disorder, unable to express will; Unable to complete the research evaluation as required
* Other contraindications of anesthesia or surgery
Protect Yourself: Abuse Prevention for People With Intellectual Disabilities

The purpose of this study is to help individuals and their caregivers develop a plan on how to recognize, deal with and respond to abusive situations.

The goal of this project is to address the current deficiencies by creating a program that will guide individuals who have intellectual disabilities and a Learning Partner (LP - care provider, relative, group home staff) in developing a comprehensive Individual Response Plan (IRP) that can be used before, during, and after an abusive event. Behavioral skills training and behavioral relaxation training -- two instructional approaches with evidence for effectiveness in this population -- will be included to address the unique learning needs of people who have intellectual disabilities and to maximize opportunities for skill-based learning. Video and workbook activities will train the LP to effectively implement the abuse prevention and response strategies, thus increasing the potential for generalization in the natural environment and long-term maintenance of skills.

Eligibility Criteria:
Inclusion Criteria:

* has moderate to mild mental retardation based on IQ scores ranging from 40-70
* is over 18 years old. --the participant must be able to do three of the following four skills (1) complete a simple worksheet with assistance, (2) go on simple errands alone, (3) recognize 10 or more words by site, (4) read a digital clock.

Exclusion Criteria:

* individuals who have experienced traumatic abuse and experiences symptoms suggestive of trauma, such as flashbacks, nightmares, and chronic anxiety and/or depression that is resistant to standard pharmacological and psychotherapy/behavior interventions.
Safety and Efficacy of Ciclesonide in Pediatric Patients (6 to 11 Years of Age) With Seasonal Allergic Rhinitis (BY9010/M1-417)

The aim of the study is to determine the efficacy and safety of ciclesonide nasal spray in children with seasonal allergic rhinitis. Ciclesonide will be administered intranasally at two dose levels once daily. The study consists of a baseline period (1 to 3 weeks) and a treatment period (2 weeks).


Eligibility Criteria:
Main Inclusion Criteria:

* Written informed consent
* General good health other than seasonal allergic rhinitis
* Positive standard skin prick test

Main Exclusion Criteria:

* Pregnancy, nursing, or plans to become pregnant or donate gametes for in vitro fertilization
* Participation in any investigational drug trial within the 30 days preceding the Screening Visit
* A known hypersensitivity to any corticosteroid or any of the ingredients in the study drug formulation
* Plans to travel outside the study area (the known pollen area for the investigative site) for 24 hours or more during the final 7 days of the baseline period
* Plans to travel outside the study area (the known pollen area for the investigative site) for more than 2 consecutive days OR more than 3 days total during the treatment period
* Use of any prohibited concomitant medications
* Non-vaccinated exposure to or active infection with chickenpox or measles within the 21 days preceding the Screening Visit
* Use of antiepileptic drugs for epilepsy within 30 days of the Screening Visit
* Study participation by more than one patient from the same household
Kinesiotape Treatment for Postoperative Edema After Joint Replacement Surgery of the Knee- The KNEETAPE Study

Postoperative edema is a common condition affecting wound healing and function. Traditionally, manual lymphatic drainage and compressive bandages have been employed to reduce swelling. Kinesiotaping might be an alternative approach. To analyse the efficacy, cost-effectiveness, satisfaction, quality of life, functional outcome and and morbidity of the use of kinesiotape for the treatment of postoperative edema after knee replacement surgery, compared to standard manual lymphatic drainage with compression (i.e. compressive stockings or bandages) or sham taping.


Eligibility Criteria:
Inclusion Criteria:

* Joint replacement surgery of the knee including conversion from partial to total joint replacement or revision surgery
* Informed Consent as documented by signature

Exclusion Criteria:

* Isolated retropatellar replacement or revision surgery for infection
* Contraindications to manual lymphatic drainage and compression treatment (i.e. compressive stockings or bandages) e.g. heart failure
* Contraindication to kinesiotape treatment, e.g. hypersensitivity to medical glue
* Dermatoses at or around the surgical site
* Suspected or confirmed local infection
* Participation in another trial with investigational drug within the 30 days preceding and during the present trial
* Enrolment of the investigator, his/her family members, employees and other dependent persons
* Inability for consent or assent by the patient, or lack of proxy consent in assenting patients with signs of incapacity.
Tislelizumab Combined With Apatinib and Oxaliplatin Plus S1 Vs Oxaliplatin Plus S1 as Neoadjuvant Therapy for Borrmann IV、Large Borrmann III Type and Bulky N Positive Advanced Gastric Cancer

To evaluate the clinical efficacy and safety of Tislelizumab combined with apatinib mesylate, oxaliplatin plus S1 Vs oxaliplatin plus S1.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-70 years of age.
* Histologically confirmed gastric adenocarcinoma was diagnosed in patients with locally advanced gastric cancer with tumor volume \>5cm Borrmann III, Borrmann IV and BulkyN according to AJCC Version 8.
* Measurable lesions at least should be detected by CT/MRI examination in accordance with the RECIST1.1.
* ECOG（Eastern Cooperative Oncology Group）PS（Performance Status）:0-1 scores.
* No previous surgical treatment, anti-tumor chemoradiotherapy/immunotherapy was performed.
* Preoperative endoscopic examination confirmed no positive peritoneal implantation metastasis and exfoliated cells.
* The expected survival time is more than 6 months.
* For women of reproductive age, a urine or serum pregnancy test with negative results should be performed within 3 days prior to receiving the first study drug administration (day 1 of cycle 1).If a urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is requested.Women of childbearing age were defined as at least 1 year after menopause or having undergone surgical sterilization or hysterectomy.

Exclusion Criteria:

* Diagnosis of malignant diseases other than gastric cancer within 5 years prior to first administration (excluding radical basal cell carcinoma of the skin, squamous carcinoma of the skin, and/or radical resectable carcinoma in situ).
* Significant clinical bleeding symptoms or clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer or vasculitis, etc. occurred within 3 months before enrollment. If fecal occult blood was positive at baseline, reexamination could be performed，if it was still positive after reexamination, gastroscopy was required.
* Prior treatment: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target another stimulating or co-inhibiting T-cell receptor (e.g., CTLA-4, OX-40, CD137).
* A history of immunodeficiency, including HIV testing positive.
* Is currently participating in an interventional clinical study or has been treated with another study drug or study device in the 4 weeks prior to initial dosing.
* Patients who had a history of cardiovascular and cerebrovascular diseases and were still taking thrombolytic drugs or anticoagulants orally.
* HER2 positive is known.
* Patients with previous gastrointestinal perforation, abdominal abscess or recent intestinal obstruction (within 3 months) or imaging or clinical symptoms suggesting intestinal obstruction.
Anti-phobic and Safety Behaviors in the Treatment of Acrophobia

This study tests whether a single session of exposure therapy may be enhanced by the addition of anti-phobic actions beyond the mere fading of safety behaviors. A total of 100 acrophobic participants will be randomly assigned to receive standard exposure therapy (EXP), exposure therapy with safety behavior fading (EXP + SBF), exposure with safety behavior fading and anti-phobic actions (EXP + SBF + AA), or to a wait-list control group (WL).

This study tests whether a single session of exposure therapy may be enhanced by the addition of one of two augmentation strategies, including engagement in anti-phobic actions and fading of safety behaviors. Because utilization of safety behaviors is functionally precluded by anti-phobic action, the present study design will both replicate and extend prior research by addressing whether anti-phobic actions enhance exposure therapy beyond the mere fading of safety behaviors. A total of 100 individuals between the ages of 18 and 65 meeting DSM-IV criteria for acrophobia (fear of heights) will be randomly assigned to one of four conditions including (1) standard exposure therapy, (2) exposure therapy with safety behavior fading, (3) exposure therapy with safety behavior fading and anti-phobic actions, and (4) a wait-list control condition. All participants will complete an online prescreen and face-to-face screening assessment to determine eligibility and pre-treatment symptom severity. Participants will also complete assessments at post-treatment and 1-month follow-up assessments. Subjective fear during two behavioral approach tests (in the treatment and generalization context, respectively) conducted at pre-treatment, post-treatment, and 1-month follow-up assessments will serve as the primary measure of treatment outcome. Additionally, a battery of self-report questionnaires will be completed at pre-treatment, during treatment, at post-treatment, and at a 1-month follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 65.
2. Fluent in English (written and spoken). This is required because assessment instruments are validated only in English.
3. Meet DSM-IV criteria for specific phobia, natural environment type, with acrophobic concerns, based on the Composite International Diagnostic Interview (CIDI-Auto; World Health Organization, 1997).
4. Report moderate fear or avoidance (i.e., a score of 30 or higher) on a modified version of the Acrophobia Questionnaire (AQ; Cohen, 1977).
5. Exhibit at least moderate fear (i.e., a fear score of 50 or higher, where 0 = no fear and 100 = extreme fear) during two behavioral approach tests (BATs) consisting of ascending two moderately challenging flights of stairs.

Exclusion Criteria:

1. Medical condition(s) which may prevent safely climbing or descending stairs or walking for more than 15 minutes at a time (It will be necessary to walk to different sites for the behavioral approach tests).