cyrilzakka/clinical-trials huggingface dataset:
The Effects of Simulation-based Ultrasound Training on Continuity of Care in Managing Pre-mature Onset of Labor

Simulation-based training lead to improvements in learning compared to no intervention but little is known of the effects on organizational improvements that are relevant to patient care. This study focused on the effects of training midwives in performing cervical ultrasound scans on continuity of care when managing pregnant women with symptoms of premature onset of labor. Our hypothesis is that simulation-based training can be used to decrease the number of shifts in primary responsible health care practitioner as midwives that are trained in cervical ultrasound scans may manage the patient encounter without engaging a second practitioner (i.e. an obstetrician).

Pregnant women with symptoms of premature onset of labor are typically managed by midwives and obstetricians but shifts in responsibility in patient care may result in lack of continuity of care. This may, in turn, result in threats to patient safety and delays in initiation of treatment due to long wait times.

This study examined the effects of simulation-based ultrasound training on the management of women with symptoms of pre-mature onset of labor. 12 midwives were randomized to simulation-based ultrasound training focusing on cervical assessment or no training (controls). The midwives in the intervention group were trained to an expert criterion on a high-fidelity transvaginal ultrasound simulator. Once this level was attained, they continued clinical training until proficiency in performing cervical scans independently. Proficiency was determined using a previously validated assessment instrument (the Objective Structured Assessment of Ultrasound Skills) and by sending in pictures for the Fetal Medicine Foundation certification programme.

The number of responsible health care practitioners providing care for pregnant women with acute onset of symptoms of premature onset of labor is registered along with time from arrival at the hospital to medical assessment and treatment is commenced. Differences between patients treated by the two groups of midwives are compared over a period of 6 months. During this period all patients with symptoms of premature onset of labor are included, of which only a small proportion are admitted for further examinations and treatment. The vast majority are expected to be scheduled for ambulatory follow-up.

Eligibility Criteria:
Inclusion Criteria:

All midwives who are taking shift on the maternity ward

Exclusion Criteria:

Any prior ultrasound training and planned maternity leave.
Enhancing Physical Activity and Healthy Aging Among Recent Retirees

The purpose of REACT project is to provide cost-effective way to promote physical activity and reduce sedentary time among older adults. This is done by examining the efficacy of activity tracker based intervention on wake-time physical activity, sedentary time, sleep and other health outcomes among recent retirees. REACT study will be the first randomized physical activity trial targeted to time window right after retirement.


Eligibility Criteria:
Inclusion Criteria:

* actual retirement date between Jan 2017 and Dec 2018
* maximum of 12 months from the actual retirement
* capable of doing exercise (able to walk 500 m continuously)
* basic knowledge on how to use computer and Internet access at home

Exclusion Criteria:

* current post-operative state or upcoming surgery within the next 6 months
* malign cancer or recent myocardial infraction
Thrombohemorrhagic Complications of COVID-19

The nature of the planned study:

The topic is of an applied nature and is aimed at improving the results of comprehensive treatment of patients with COVID-19, the course of whose disease was complicated by thrombotic or hemorrhagic catastrophes.

It is planned to analyze the results of treatment of this category of patients based on the work of several centers that provided surgical care to patients with COVID-19 during the pandemic (8 cities).

As a result of the analysis, it is planned to develop algorithms for the prevention and treatment of thrombotic and hemorrhagic complications in patients with COVID-19.

The proposed study will be multicenter, cohort, retrospective.

The purpose of the study:

Improvement of treatment results in COVID-19 patients with thrombotic or hemorrhagic complications

Scientific novelty:

For the first time, as a result of a multicenter study, it is expected to identify the most effective approach to the treatment and prevention of thrombotic and hemorrhagic complications in patients with COVID-19.

For the first time, it is planned to develop and put into practice algorithms for the application of the most effective methods of treatment and prevention of thrombohemorrhagic complications of COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Patients with thrombohemorrhagic complications who were treated in a covid hospital

Exclusion Criteria:

* Cancer patients
* Patients who had thrombohemorrhagic disorders before admission to the hospital
* Pregnant women
* Patients receiving routine anticoagulant and antiplatelet therapy before admission to the hospital
Endovascular Treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI)

The aim of this study is to assess the efficacy of endovascular treatment (balloon angioplasty and/or stenting) for the improvement of clinical symptoms in multiple sclerosis patients.

The aim of this study is to assess the efficacy of endovascular treatment (balloon angioplasty and/or stenting) for the improvement of clinical symptoms in multiple sclerosis patients measured by Extended Disability Severity Score (EDSS), Multiple Sclerosis Impact Scale-29 (MSIS-29), Fatigue Severity Scale (FSS) and heat intolerance

Eligibility Criteria:
Inclusion Criteria:

* patients with clinically defined multiple sclerosis

Exclusion Criteria:

* contraindication for endovascular procedure performed in local anesthesia
A Supervised Clinic-to-Community Exercise Intervention to Improve Cardiometabolic Health in Survivors of AYA Cancer

The main goal of this clinical trial is to use a novel exercise intervention to improve cardiometabolic and biopsychosocial health outcomes in overweight/obese sedentary survivors of AYA cancers at risk for chronic comorbid conditions. The investigator's hypothesis is that an exercise intervention will improve: cardiometabolic health; body composition; physical fitness and biopsychosocial outcomes when compared to the attention control group.


Eligibility Criteria:
Inclusion Criteria:

* AYA cancer survivors (18-39) Must be 12 months after treatment No metastatic disease

Exclusion Criteria:

* Metastatic disease Pregnancy
A Post-marketing Observational Study Of The Use Of Zonisamide (ZNS) in the Adjunctive Treatment Of Adult Patients With Partial Onset Seizures (Study E2090-E044-410) (ZOOM)

This is a Non-interventional Prospective Study. Centres will enroll adult patients with partial onset seizures for whom the clinician has decided to initiate ZNS as an adjunctive therapy prior to the decision to take part in this study. Patients to be enrolled into the study are not sufficiently controlled with one dug licensed for the use of monotherapy in partial onset seizures. Patients will be seen at baseline and then during normal clinical visits at intervals which are appropriate to the typical practice of the treating clinician. Patients will be assessed at baseline and then at least 3 and 6 months after the baseline.

Open-label, Multi-centre, Multi-national Post-marketing, Non-interventional Observational Study

Eligibility Criteria:
Inclusion Criteria:

* The decision to prescribe ZNS was made by the physician before and independently of his/her decision to include the patient in the study
* Patients treated with one drug licensed for the use as monotherapy in partial onset seizures
* Based on the physician's clinical judgment, the patient seizure activity is not controlled sufficiently with the current monotherapy and it is in the patient's best interest to be prescribed adjunctive ZNS
* Patient was prescribed ZNS no longer than 2 weeks before baseline
* Treatment with ZNS has to be commenced in line with the drug's license and ZNS SmPC (Summary of Product Characteristics)
* Aged 18 years or older
* Capable of understanding the purpose of the study, fully informed and having given written informed consent.

Exclusion Criteria:

* Patients that have started ZNS outside the approved SmPC at enrolment
* Simultaneous participation in an interventional clinical trial and/or taking an investigational drug
* Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the patient.
Acute Phase Reactions and Thrombophilia in Pediatric Patients With Migraine

Acute Migraine attacks can be related to vascular or coagulation activation. Previous studies found relative high incidence of prothrombotic events in Migraine. The present study intends to assess the coagulation system and activation in patients with Migraine during steady state phase and at the beginning of attacks and after 72 hours. A control group of patients with another acute neurologic event like convulsions will be also studied. Patients will be at pediatric age and teenagers.


Eligibility Criteria:
Inclusion Criteria:

* Patients at the pediatric age (5 to 20 ys old) suffering from Migraine attacks diagnosed by a neurologist.

Exclusion Criteria:

* Patients with other underlying neurological conditions of coagulation diseases
The Effect of Intensive Insulin Therapy in the Surgical Critical Care Unit

We sought to determine if there is a benefit to using an insulin drip to control hyperglycemia in the surgical critical care unit for patients who undergo general and vascular surgery.

While evidence exists for using tight glycemic control in the critically ill cardiac surgical patient, other patient populations have yet to be studied. We performed a prospective randomized trial for using intensive insulin therapy in the general and vascular critically ill surgical patient population. We will compare tight glycemic control versus conventional glycemic control to determine if there is a benefit to the normalization of blood glucose levels in this patient population

Eligibility Criteria:
Inclusion Criteria: Patients undergoing a general or vascular surgical procedure requiring admission to the surgical intensive care unit as a result of ventilatory requirement, vasopressor support, or physiologic instability

-

Exclusion Criteria:

* Under age 18
Expanded Access Protocol for Subjects With Relapsed or Refractory Advanced Solid Tumors Receiving TJ210001

This EAP was designed to provide TJ210001 to the remaining subjects with relapsed or refractory solid tumors who were enrolled on the parent study, TJ210001STM101 (NCT04678921), and plan to continue with treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females, of any race, age ≥ 18 years;
2. Participation in the parent TJ210001STM101 study and thought to have potential to derive clinical benefit from continued treatment in the opinion of the parent study investigator from uninterrupted dosing of TJ210001;
3. Willingness and ability to comply study treatment and standard of care testing and procedures;
4. Women of childbearing potential (WOCBP) must:

   1. Agree to use at least 2 effective contraceptive methods (1 highly effective method in combination with a barrier method; oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner), one of which must be barrier, from signing the ICF, throughout the study, and for up to 12 weeks following the last dose of TJ210001;
   2. Avoid conceiving for 12 weeks after the last dose of TJ210001;
   3. Avoid donation of ova until 12 weeks after the last dose of TJ210001;
   4. Agree to ongoing urine pregnancy testing, if clinically indicated, during the course of the study.
5. Males must agree to use a condom (a latex condom is recommended) during sexual contact with a pregnant female or a female of childbearing potential and will avoid donation of sperm or having a female partner conceive from the time of signing the ICF, while participating in the study, during dose interruptions, and for at least 12 weeks after the last dose of study treatment, even if he has undergone a successful vasectomy;
6. Patient or patient's health care proxy is able and willing to provide written informed consent and able to follow study instructions.

Exclusion Criteria:

* Any unresolved ongoing toxicity or clinical event that would make continued treatment with TJ210001 inappropriate; 2. Current treatment on another therapeutic clinical trial; 3. Currently pregnant; 4. Current evidence of any condition (including medical, psychiatric or substance abuse disorder), therapy, or laboratory abnormality that might interfere with the patient's participation or is not in the best interest of the patient to participate, in the opinion of the treating Investigator
A PK/PD Study of Fospropofol Disodium Compared With Propofol Injectable Emulsion

This study is designed to characterize the pharmacokinetic and pharmacodynamic effect of fospropofol disodium in comparison to propofol. In addition, the study will compare the maximum sedative effect, safety and tolerability of fospropofol disodium and propofol.


Eligibility Criteria:
Inclusion

* Males or females greater than or equal to 18 or less than or equal to 45 years old
* Non-smokers for at least 18 months prior to Screening
* Body Mass Index (BMI) less than or equal to 30 Exclusion
* Subjects having a past or current medical history of any respiratory illness including asthma
* Subjects currently taking any medications (birth control will be allowed if the subject has been taking it for at least 12 weeks prior to dosing and during the entire study), including over-the-counter (OTC) medication, within 14 days of Screening
* Subjects with a known or suspected history of drug or alcohol misuse within 6 months prior to Screening, or who have a positive urine drug test at Screening and pre-dose at Visit 2 and Visit 3
* Subjectw who are allergic to eggs, egg products, soybeans, or soy products
* Subjects with a positive pregnancy test at Screening or breastfeeding
* Subjects who are unwilling or unable to abide by the requirements of the study
* Subjects who have any condition that would make him/her, in the opinion of the investigator, unsuitable for the study or who, in the opinion of the investigator, are not likely to complete the study for any reason
Home Improvement Initiative of the TRaitement Optimisé Medicamenteux After Hospitalization

The hypothesis is that the intervention of an operational clinical pharmacy team (EOPC), targeting both patients and hospital and health care professionals, allows: i) to initiate a therapeutic review during hospitalization, ii) to accompany the patients upon hospital discharge, iii) to maintain, in outpatient care, the drug treatments that have been optimized during hospitalization.

The main objective of the study is to demonstrate that the intervention of an EOPC in surgical departments and then in outpatient care makes it possible to maintain, 45 days after the discharge of the patients aged 65 years and over, the chronic outpatient treatments revised and optimized during the hospital stay.

The secondary objectives are to measure the impacts of EOPC's intervention on:

* unexpected readmissions, emergency use, medical complications and adverse drug reactions;
* patient and health professional satisfactions (community pharmacists and physicians);
* the costs of drug treatments in ambulatory care.


Eligibility Criteria:
Inclusion Criteria:

* Patient (man or woman)
* age ≥ 65 years with more than 3 drugs taken for 3 months, stay in surgery with a duration of ≥ 1 days including urgent surgery;
* affiliated to a social health insurance scheme;
* for whom a return home is possible;
* able to understand the objectives of the research and give informed, dated and signed consent.

Exclusion Criteria:

* Patient (man or woman)
* with as a hospital discharge an entry into a nursing home or long-term care called "important medical and technical care (SMTI);
* with cognitive or other problems preventing consent (at the discretion of the geriatric expertise team);
* under the safeguard of justice;
* under tutorship or curatorship.
Protein Synthesis in Midthigh Muscles PET/CT

The purpose of this study is to test a new imaging technique to help scientists study sarcopenia, the process by which muscle becomes weaker with age.


Eligibility Criteria:
Inclusion Criteria:

* young healthy women aged 25-35 years and older healthy women above 70 years old.

Exclusion Criteria:

* no cardiac disease, not taking medication for high blood pressure Asthma HIV any other cardiac conditions
Evaluating the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan

The purpose of this study is to evaluate the efficacy and safety of co-administrated Rosuvastatin/Ezetimibe and Telmisartan in patients with primary hypercholesterolemia and essential hypertension.

This trial is a phase 3 study to evaluate efficacy and safety of co-administrated Rosuvastatin/Ezetimibe and Telmisartan in patients with primary hypercholesterolemia and essential hypertension.

In "Rosuvastatin/Ezetimibe+Telmisartan" treatment group, 60 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe+Telmisartan" for 8 weeks.

In "Rosuvastatin/Ezetimibe" treatment group, 60 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe" for 8 weeks.

In "Telmisartan" treatment group, 60 subjects will be assigned and the subjects administer "Telmisartan" for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Subjects with hypertension and hyperlipidemia

Exclusion Criteria:

* Patient with known or suspected secondary hypertension
* Other exclusions applied
Food-based Solutions for Optimal Vitamin D Nutrition and Health

This project aims at proving the efficacy and safety of food based solutions to prevent vitamin D deficiency in high risk populations of Caucasian and South Asian origin living in Denmark.

The study is a 12 week double-blinded, randomised, placebo-controlled food-based intervention trial in a real-life setting. 140 (18-50 y) women in risk of vitamin D deficiency and with Caucasian or South Asian origin. The two ethnic groups of women will each be randomised into two groups. One receiving vitamin D fortified foods and the other receiving the same kind of foods non-fortified. Foods given in the study period are free of charge for the participants and will be handed out every second week. The foods are eggs, yoghurt, cheese and crisp bread.

The study includes a baseline visit and a final visit, at both visits blood samples will be drawn, anthropometrics, muscle strengths, dietary and background questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* 18-50 year old women
* Low consumption of fish and fish products
* Low intake of vitamin D containing supplements
* No use of sunning facilities
* No planned sun-holiday between October 2015 and May 2016

Exclusion Criteria:

* Pregnancy and breastfeeding
* Menopause
* Serious diseases (cancer, server liver or kidney insufficiencies, sarcoidosis and other granulomatous diseases) and medicines affecting the vitamin D metabolism (steroids, antiepileptic, thyroid hormones, bisphosphonates, oestrogen).
Estimation of the Difference Between the Temperature of the Peritoneal Microenvironment and the Central Body Temperature During Laparoscopic Surgery. Prospective Observational Study

Estimation of the difference between the temperature of the peritoneal microenvironment and the central body temperature during laparoscopic surgery. Prospective observational study.

Prospective unblinded observational study to measure the difference between central and peritoneal temperature during laparoscopic surgery.

CO2 insufflation at the peritoneal level to generate the pneumoperitoneum necessary to perform laparoscopic surgery results in a decrease in peritoneal temperature greater than that generated at the central level (esophageal temperature).

The potential long-term advantages of maintaining normothermia at the peritoneal level during laparoscopic surgery may derive from the reversal of the harmful effects of hypothermia at the level of the peritoneal microenvironment since the regional hypoxia resulting from vasoconstriction and the inhibition of functionality cellular that can favor complications such as bleeding or suture dehiscence.

On the other hand, the immune system can be affected by regional hypothermia in several ways. First, postoperative vasoconstriction restricts metabolic heat to the central regions of the body and accelerates overheating, but can simultaneously reduce tissue perfusion by inhibiting oxidative destruction of neutrophils, which is the first line of defense against bacterial contamination. Second, hypothermia reduces systemic immunity and decreases macrophage motility. Third, hypothermia reduces the recovery capacity necessary for wound contamination.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years.
* Classification of the American Society of Anesthesiologists (ASA I-III).
* Patients who do not have cognitive deficits.
* Prior signed informed consent.

Exclusion Criteria:

* Pregnancy or breastfeeding.
* Refusal of the patient to participate in the study.
Longitudinal Study of Chronic Wounds Using Novel Wound Measurement Technologies

An open, non-randomised longitudinal study of diabetic foot ulcers receiving standardised treatment, over a 16 week period conducted at out-patient level, utilising novel optical wound measurement technologies.

Diabetic foot ulcers are a major burden on the healthcare system, and it is highly desirable to develop a practical, reliable, non-invasive means of diagnosing, assessing and measuring wound healing, so as to provide wound care specialists with key data with which to make effective decisions for clinical management.

Optical coherence tomography (OCT) is a novel technique of imaging of cutaneous tissue. Using low-power infrared light, it is a non-invasive in-vivo imaging technique which provides resolution of \<10microns to a depth of 1 - 1.25 mm in skin, (adequate to resolve capillaries) utilizing the optical scattering characteristics of tissue to provide imaging contrast.

This open, non-randomised, observational study will assess the feasibility of using OCT to diagnose chronic diabetic foot ulcers. One cohort of 15 patients will be scanned over a 16 week period and results studied to determine whether there is an association between rate of wound healing and OCT measurements.

Eligibility Criteria:
Inclusion Criteria:

* Defining ABPI ≥0.5 - \<1.2
* Patients with DFU for over 4 weeks but less than 1 year duration. DFU resulting from neuropathy will be included.
* Neuropathy scores defined by 10g Semmes-Weinstein monofilament tests at 10 sites on plantar and dorsal surfaces

Exclusion Criteria:

* Patients with uncontrolled diabetes, the Charcot Foot, cancer (except non-melanoma skin cancer in the limb), decompensated cardiac failure, clinically significant renal failure, history of stroke or significant peripheral arterial disease, or those who are pregnant, or on a waiting list for interventional therapy.