cyrilzakka/clinical-trials huggingface dataset:
Tele-Support for Emergency Medical Technicians

In this manikin-based simulation study the impact of tele-support during a simulated pediatric out-of-hospital cardiac arrest scenario on emergency medical technicians' guideline adherence, on gaze behavior as well as on performance of resuscitation management and cognitive load will be analyzed.

80 emergency medical technicians (EMT) will take part in this simulation study. The participants will be confronted with a scenario of an 8-year old boy, while wearing eye tracking glasses. In a parallel group design, the teams will be randomly assigned to a group performing advanced life support (ALS) without further support (group 1) or with additional tele-support (group 2). In case of support, an emergency physician assists the team performing the cardiopulmonary resuscitation management via a real-time remote connection.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Active work as an emergency medical technician

Exclusion Criteria:

* Pregnancy
* Prior knowledge of study setting or simulation scenario
Psychological distREsS hipEc oR pelVic Exenteration

The purpose of this study is to describe type and extent of psychological distress (adverse effects) in patients undergoing surgery for colorectal cancer with peritoneal metastases and after surgery for colorectal cancer with involvement of the urinary bladder.

After being informed about the study all patients giving written informed consent will be distributed a questionnaire asking questions on depression, anxiety, self-reported cognitive issues, sleep issues, quality of life and 'fear of cancer recurrence'. All these aspects will be investigated using validated questionnaires.

Once the investigators have the preliminary results (type and extent of psychological distress developed after CRS+HIPEC or PE) the investigators plan to conduct a workshop. In this workshop experts in different areas regarding psychological distress, project leaders, professor from the 'National Center of Late Adverse Effects after Cancer in Pelvic Organs' (Denmark) and patients will participate. With the input of experts and patients, a treatment strategy will be developed, and also an assessment will be made concerning which patients are likely to benefit from treatment by these experts, and which patients could potentially benefit from counselling by their general practitioner or via self-helping tools at home. The investigators plan to conduct this workshop autumn 2021 and start counselling spring 2022.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone intended curative CRS+HIPEC for peritoneal metastases originated from colorectal cancer (HIPEC cohort) according to national Danish guidelines
* Patients who have undergone intended curative total or anterior pelvic exenteration (PE cohort) for advanced or recurrent colorectal cancer according to national Danish guidelines

Exclusion Criteria:

* Patients under 18 years
* Patients not speaking Danish or Swedish, respectively, in Denmark and Sweden
* Patients unable to give informed consent
* Patients undergoing CRS+HIPEC or PE for cancers others than CRC
* Terminally ill patients
ICS/LABA Adherence and COPD Exacerbation

The purpose of this retrospective, non-interventional sutdy is to compare the effectiveness of ICS/LABA combination therapy in the reduction of COPD exacerbations during the 12 months after initiation of therapy between COPD patients who are adherent to the index medication and those who are non-adherent.

This retrospective, observational study will assess the effectiveness of ICS/LABA combination therapies among COPD patients new to the ICS/LABA combination therapies in the US, comparing those who are adherent to the index medication and those who are non-adherent. Adherence will be measured using the proportion of days covered with the index medication. Medical and pharmacy claims data will be used as the data source.

Eligibility Criteria:
Inclusion Criteria:

* at least one prescription fill for ICS/LABA combination during identification period.
* COPD diagnosis
* 40 years or older at index date
* \> or = 12 months of continuous health plan enrollment prior to and following index date
* 1 or more prescription for SABA, SAMA or SABA/SAMA during the pre-index period.

Exclusion Criteria:

* Patients with prescription claim for ICS/LABA combination therapy during the 12 month pre-index period
* Patients receiving oral corticosteroid medication for more than 180 days during the 12 month pre-index period
* Patients with cancer diagnosis in 12 month pre-index period
Evaluation of the Effect of Changyou Probiotic Flavored Yogurt on Intestinal Health

This was a randomized, double-blind, single-center, placebo-controlled, three-arm study.

The objectives of this study were to evaluate the effect of the Bright Changyou Probiotic Flavored Yogurt on:

Improving gastrointestinal health; Relieving symptoms of functional constipation or functional diarrhea; Improving gut immunity; Adjusting microbiological flora in gastrointestinal tract.


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 25-45 years old;
* Functional constipation or diarrhea diagnosed by Rome III criteria;
* Agree not to take any dietary supplements or dairy products other than the study products during the study period;
* Agree not to take any supplements or dairy products containing prebiotics/probiotics other than the study products during the study period;
* Agree not to participant in other interventional studies during the study period;
* Fully understand the property, purpose, benefits and potential risk and side effect from the study;
* Agree to follow all study requirements and procedures;
* Signed informed consent.

Exclusion Criteria:

* Currently receiving treatment for gastrointestinal symptoms;
* Lactose intolerance;
* Having diseases or conditions that may affect intestinal function, such as history of gastrointestinal resection, colon or rectal cancer, inflammatory bowel disease, diabetes, hyperthyroidism or hypothyroidism, Hirschsprung's disease, scleroderma, or Anorexia nervosa;
* Currently under diet control or in use of medicine or supplements for weight control or that might affect appetite;
* Have had laxatives or other substance that will enhance digestion within two weeks before the study begins;
* Have had dairy products or other food containing probiotics within 10 days before the study begins;
* Currently having diarrhea;
* Currently pregnant or breast-feeding, or plan to be pregnant during the study period;
* Not be able to follow study procedures according to investigators evaluation.
Examination of Left Atrial Fibrosis Using MRI

This study evaluates images obtained from a standard clinical cardiac MRI for evidence of fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* 18+ years of age
* being scheduled for a standard of care MRI

Exclusion Criteria:

- patient unable to provide informed consent
Comparing Patient Comfort and Safety Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography

The purpose of this study is to evaluate and compare overall patient comfort profile between an Iso-osmolar contrast media (IOCM), iodixanol 320 mg I/mL, and a Low-osmolar contrast media (LOCM), iopamidol 370 mg I/mL in patients undergoing arteriography of peripheral arteries.


Eligibility Criteria:
Inclusion Criteria:

* The subject is over 18 years old.
* Subjects are referred to undergo a peripheral arteriography as part of their routine clinical care.

Exclusion Criteria:

* The subject has known allergies to iodine or any prior history of adverse reaction to iodinated CM.
* The subject received another administration of CM within 24 hours prior to baseline or is scheduled to receive one within the 24 hour follow-up period.
* The subject is pregnant or lactating.
* The subject is taking metformin (e.g., Glucophage®) but is not willing or unable to discontinue at the time of the study procedure.
* The subject manifests thyrotoxicosis or is on dialysis.
Board Game Intervention to Improve Cognitive and Daily Functioning

Background:

With the rapid rise of the aging population, the number of seniors with mild cognitive impairment (MCI) has increased, and without timely interventions, participants are at high risk of developing dementia. Board games have become a popular tool for cognitive training, but many board games may not be appropriate for seniors and lack the support of empirical research.

Objectives:

To examine the effectiveness of a 12-week board game intervention for MCI seniors in improving cognitive functioning and scores on the instrumental activities of daily living (IADL) scale.

Methods:

A single-blind randomized controlled trial was conducted to collect data from a long-term care facility in central Taiwan. Sixty-eight MCI seniors were recruited and randomized into a board game group (trial group) and a health promotion group (control group). Participants in both groups received a 2-hour intervention once a week for 12 weeks, with the trial group receiving 12 weeks of board games and the control group receiving 12 weeks of health promotion activities. Before and after the intervention, the primary assessment was conducted using the Saint Louis University Mental Status Exam, Contextual Memory Test, and Trail Making Test part-A; the secondary assessment was conducted using the IADL scale.


Eligibility Criteria:
Inclusion Criteria:

* aged 65 years or older without a diagnosis of dementia
* mild neurocognitive impairment

Exclusion Criteria:

* non-national senior citizens
* unable to understand the content and complete the questionnaire
* unable to participate in the full 12-week intervention
* had an acute illness such as a cold during the trial.
GON-block in Chronic Migraine: a Randomized, Double- Blind, Placebo-controlled Study

Infiltration of the greater occipital nerve (GON) with local anaesthetics and corticosteroids is a treatment option for cluster headache. Corticosteroids may be helpful in reducing the pain intensity and frequency in chronic migrtaine. This RCT is set up to assess efficacy and safety of sub-occipital steroid injections with local anesthetic in patients with chronic migraine.

Infiltration of the greater occipital nerve (GON) with local anaesthetics and corticosteroids is a treatment option for cluster headache. In general, there is a marked paucity of evidence concerning GON blocks in migraine. Corticosteroids may be helpful in reducing the pain intensity and frequency in these patients. This is an RCT to assess efficacy and safety of sub-occipital steroid injections with local anesthetic in patients with chronic migraine.

Eligibility Criteria:
Inclusion Criteria:

* Chronic migraine

Exclusion Criteria:

* Medication overuse headache
"Effectiveness of the Ultrasound - Guided Lengthening of the Gastrocsoleus Complex"

The study analyzes the effectiveness of different ultrasound-guided surgical techniques to treat gastrocnemius contracture and equinus deformity, conditions that affect ankle dorsiflexion and can cause problems such as plantar fasciitis and metatarsalgia. Four techniques were compared: Strayer, Plantaris, Baumann and Gastro-soleo, evaluating their impact on the improvement of ankle motion.

Equinus deformity is a common deformity caused by contracture of the triceps suralis, especially the gastrocnemius. This causes limitation of ankle dorsiflexion, pain and gait incompetence. Treatment includes surgical lengthening techniques such as gastrocnemius tendon recession (Strayer) or isolated plantar tendon transection.

The minimally invasive Strayer technique is effective but carries morbidity. Ultrasound-guided plantar tendon transection is a new minimally invasive technique but its effectiveness has not been well established.

The study will evaluate the effectiveness of four ultrasound-guided surgical techniques in improving ankle dorsiflexion in patients with equinus due to gastrocnemius contracture. The Strayer, Plantaris, Baumann, and Gastro-soleo techniques will be compared, analyzing their impact on mobility before and after surgery.

Patients will be assigned to different groups based on the applied technique, following specific inclusion and exclusion criteria for each procedure. For statistical analysis, Wilcoxon and paired Student's t-tests will be used, depending on data distribution. Additionally, a repeated-measures ANOVA with Tukey's post-hoc tests will be applied to compare the results between techniques and determine which achieves the greatest increase in dorsiflexion range.

All techniques are expected to significantly improve dorsiflexion, with differences in the magnitude of change. The Gastro-soleo technique is anticipated to show the highest absolute increase, while Strayer may be the most statistically effective.

The study complies with ethical requirements and has the approval of the ethics committee of the Catholic University of Valencia.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and radiological diagnosis of clubfoot.
* Limitation of passive dorsiflexion of the ankle (\<10°).
* Associated pain and functional limitation
* Absence of previous ankle/foot surgeries

Exclusion criteria:

* Neurologic or congenital disease.
* Advanced ankle joint osteoarthritis
* Peripheral vascular insufficiency
* Uncontrolled diabetes mellitus
* Severe hepatic or renal disease
* Coagulopathies or anticoagulant therapy
IGF-I Stimulation of Collagen Synthesis in Ehlers-Danlos Patients

The investigators want to inject insulin-like growth factor-I (IGF-I) into the patella tendon of Ehlers-Danlos patients and healthy controls to evaluate the response in collagen synthesis. Furthermore collagen synthesis is measured in muscle connective tissue and in skin.

The hypothesis is that the connective tissue in Ehlers-Danlos patients is more compliant and poorer in collagen than healthy controls, but that collagen synthesis can be stimulated by IGF-I.

IGF-I will be injected with ultrasound guidance to one patella tendon and the other one will be injected with saline as control. Injections will be performed double blinded and timed 24 hours and 6 hours before tissue sampling.

Collagen synthesis will be measured as fractional synthesis rate based on stabile isotope technique using labelled proline.

10 patients diagnosed with Classical form of Ehlers-Danlos syndrome will be included and matched with 10 healthy controls based on age, gender, BMI and activity level.

The muscle biopsy will be taken from vastus lateralis muscle and the skin biopsy from the buttocks. The biopsies will if the size permits it also be used for histology and mRNA analyses.

Eligibility Criteria:
Inclusion Criteria:

* Classic form of Ehlers-Danlos syndrome OR healthy matched control

Exclusion Criteria:

* Malignity, cardiac diseases, diabetes, tendinopathy in patella tendons
Communication During Medical Consultations in Singapore -Pilot

Despite advanced cancer patients and their caregivers frequently experiencing psychological distress and wanting to know about their prognosis, oncologists rarely respond with empathy and provide adequate information regarding patient prognosis. We aim to address the communication gap during consultations by developing an Oncologist E-Learning Communications Skills Training Program guiding physicians on how to recognize and respond to patient/caregiver distress and to disclose prognosis; and a Patient Prompt Sheet to encourage discussions of psychological distress and prognosis. We will assess the feasibility of delivering this two-component intervention program within a cancer center in Singapore through a 2-arm randomized controlled trial in which 8 oncologists will be randomly assigned to Control Arm (n=4) and Intervention Arm (n=4). Oncologists in the intervention arm will receive the E-Learning Program. Their patients will also receive the Patient Prompt Sheet before their consultation with oncologist. After completion of oncologist intervention we will audio-record and survey 3 patients with Stage IV cancer and their caregivers per oncologist before and after their consultations. If the study is shown to be feasible and acceptable, then its effectiveness will be assessed in a larger trial.


Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria for oncologists are

1. All consultants and senior residents/registrars in the Departments of Medical Oncology at National Cancer Centre, Singapore
2. Able to allow audio-recording during consultation

The inclusion criteria for patients are

1. Age ≥ 21 years old
2. Patients who are consulting an oncologist who is participating in the study
3. Patients who are Singaporeans or Singapore Permanent Residents
4. Diagnosis of stage IV cancer (with metastasis to visceral organs)
5. Able to allow audio-recording during consultation

Exclusion Criteria:

The exclusion criteria for oncologists are

a. Rejecting audio-recording during consultation

The exclusion criteria for patients are

1. Age ≤ 21 years old
2. Patients who are not Singaporeans or Singapore Permanent Residents
3. Rejecting audio-recording during consultation
4. Patients with psychiatric or cognitive disorder.
Improving Antibiotic Prescribing Practices in Mexican Primary Care Clinics

The purpose of this study is to improve antibiotic prescribing practices of Mexican primary care physicians for patients seeking care for acute respiratory tract infections (ARIs). The investigators will employ a combination of qualitative and quantitative methods to develop and evaluate a patient education and physician decision-support intervention.

Hypothesis 1: The investigators will identify barriers and facilitators of appropriate antibiotic use for ARIs that can be addressed through patient education and physician decision-support.

Hypothesis 2: The proportion of patients who report desire for antibiotics as a "very important" reason for seeking care will decrease from 50% to 30% following exposure to the educational intervention; and 90% (95% confidence interval: 80% to 100%) of patients will report that they trust the information provided by the computer.

Hypothesis 3: Antibiotic prescribing for adults with uncomplicated acute bronchitis will decrease from 80 percent to 40 percent following the introduction of a real-time clinical decision support tool.


Eligibility Criteria:
Inclusion Criteria:

* adults age 18 years or greater

Exclusion Criteria:

* mental disability; severe illness
Observational Study of Biomarker During Liver Surgery

The investigators would like to study whether Sirtuin 1 (SIRT1) plays a cytoprotective role in liver ischemia/reperfusion, and ultimately to develop therapeutic strategies to improve hepatic function of patients with liver diseases.

If asked to participate in this research study, it is because a liver resection/liver transplantation surgery has been scheduled. During the procedure a small section will be collected for additional testing of Sirtuin 1. In addition, information concerning the liver disease, laboratory and pathology results after surgery will be collected by the investigators.

Eligibility Criteria:
Inclusion Criteria:

* liver resection \> 2 segments,
* plate count \> 100 x 109/L, and
* prothrombin activity \>60%.

Exclusion Criteria:

* liver cirrhosis,
* portal hypertension,
* steatohepatitis or severe steatosis,
* patients receiving additional ablation therapies,
* laparoscopic resection, and
* simultaneous extrahepatic procedures such as colorectal resection or pancreatoduodenectomy
Ocular Comfort and Inflammation in Lid Hygiene Therapy

The primary study objectives are: to evaluate (1) the change in ocular discomfort at 30 days and (2) the change in signs and symptoms of ocular surface disease in demodex-positive subjects beginning the use of Avenova.

This is a prospective study of subjects who have been diagnosed with bilateral demodex blepharitis. Qualified symptomatic eyes will be randomized and monitored for 30 days; one eye will undergo Avenova treatment twice daily and one eye will not undergo any study treatment.

Eligibility Criteria:
Inclusion Criteria:

* Subject signed and dated a IRB-approved informed consent document
* Mild or greater Demodex (minimum 15 observable mites in six lashes)
* Score of 20 or more on the OSDI Questionnaire
* Score of 20 or more on the Eyelid Inflammation Questionnaire

Exclusion Criteria:

* Currently enrolled in another prospective research study
* Unable to attend two follow-up visits over 30 days
* Current allergic conjunctivitis of the cornea, conjunctiva, or eyelid in either eye
* Prior ocular trauma where surgery was indicated
* Prior corneal transplant in either eye
* Any ocular surgery within the past six months
* Abnormal corneal scarring, erosions, or Stevens-Johnson syndrome
* Anticipation of ocular surgery within the next 30 days
* Non-English speaking
* Pregnant, nursing, or expect to become pregnant within the next 30 days
* Known sensitivity to chlorine or Avenova
* Moderate, or severe conjunctivochalasis
* Contact lenses within the last 30 days and unwilling to discontinue for 30 days
* Use of topical cyclosporine for less than 6 continuous months prior to baseline
* Procedure such as pulsed light or commercial lid massage in last 30 days
* Known history of autoimmune disease
* Punctal plugs placed within the last 30 days
* Use of Avenova or other lid cleansers within the last 30 days
* Changes in systemic or ocular medications in the last 30 days
* Unwilling to commit to the same ocular and systemic medications for 30 days
Effect of Hypocaloric Diet and Exercise in Obese Women Who Are Subjected to IVF Cycle

The purpose of this study is to determine the impact of diet and physical exercise program on pregnancy rate and live birth in obese women who undergo an IVF cycle.

The objective of this study is showing that obesity significantly affects the in vitro fertilization cycles lowering the reproductive capacity. The study is been performed in Hospital de la Santa Creu i Sant Pau and Fundació Puigvert of Barcelona. Patients recluted are obese women with sterility problems that require in vitro fertilization (IVF) with a body mass index BMI between 30-35. It´s a randomised study in which half of the patients undergo to a 6 weeks program of diet and exercice. We will analyse the response to ovaric stimulation, the results of the egg retrieval (ovocyte number and quality), rates of fecundation, embryo implantation and clinical gestation.

Eligibility Criteria:
Inclusion Criteria:

* Women who want pregnancy.
* Basal FSH levels ≤ 10 IU / l.
* Infertility to justify treatment with IVF/ICSI.
* Being included in a long protocol with GnRH agonist.
* Presence of both ovaries and uterus able to support embryo implantation and pregnancy.
* Body mass index (BMI) ≥ 30 kg/m2 and ≤ 35 kg/m2.
* Absence of pregnancy before starting ovarian stimulation.
* Having given their written consent.

Exclusion Criteria:

* Female age ≤ 18 years and ≥ 35 years.
* Severe male factor not permit an IVF-ICSI with ejaculated sample.
* Patients with low ovarian reserve (basal FSH levels ≥ 10 IU / l or lower antral follicle count to 6 follicles in both ovaries).
* HIV seropositivity, HBV or HCV.
* Clinically important disease.
* Having frozen embryos from previous cycles of assisted reproduction.
* Unexplained vaginal bleeding.
* Poor response in previous IVF cycles with standard stimulation protocols
* Any contraindication to become pregnant.
* Known allergy to preparations of gonadotropins or its excipients.
* High consumption of alcohol, drugs or psychotropic drugs.
* Concurrent participation in another study.
* Patients who have done previous cycles of IVF / ICSI without success