cyrilzakka/clinical-trials huggingface dataset:
GnRH-a on Angiogenesis of Endometriosis

Purpose: Neo-angiogenesis is necessary for adhesion and invasiveness of endometriotic lesions in women affected by endometriosis. VEGF is one of the major components of angiogenesis and is part of the major pathway TF-PAR-2-VEGF that leads to neo-angiogenesis. SP1 is a transcriptional factor that has lately been studied for its crucial role in angiogenesis, via a distinct pathway. We hypothesize that by blocking angiogenetic pathways we can repress endometriotic lesions. GnRH-agonists are routinely used, especially pre-operatively, in endometriosis. It would be interesting to clarify which angiogenetic pathways are affected and pave the way for further research over anti-angiogenetic effects on endometriosis.

Methods: We used qRT-PCR to study mRNA expression levels of TF, PAR-2, VEGF and SP1 in endometriotic tissues of women who underwent surgery for endometriosis and received GnRH-a \[leuprolide acetate\] preoperatively.

The subjects in this study were women of reproductive age. From September 2015 to December 2022, sixty women with known endometriosis \[stage 2 and 3\], were recruited. Their mean age was 38 years. They were nulliparous and had a mean BMI of 27 kg/m2. The ovarian endometrioma, present in all the participants, was diagnosed by ultrasonography and/or magnetic resonance imaging.

This was a prospective randomized follow up study with analysis of ovarian samples derived from GnRH agonists-treated and non-treated women before surgery. The randomization was performed by accessing a central internet-based randomization program. The random allocation sequence and the assignment of the participants to interventions were made by 2 of the authors \[A.K. and S.K\].

After enrollment, patients were divided into 2 groups . During laparoscopy, biopsy specimens of the ovarian endometrioma were collected. The staging of endometriosis was based on the rASRM classification system. In group B, surgery was performed during the proliferative phase of the menstrual cycle. All biopsy specimens were collected in accordance with the guidelines of the Declaration of Helsinki and with the approval of the ethical committee of the General University Hospital of Patras. Informed consent was obtained from all women.

Eligibility Criteria:
Inclusion Criteria:

* reproductive age.
* endometriosis \[stage 2 and 3\]
* nulliparous

Exclusion Criteria:

* women who received any hormonal treatment within the 12 months before the surgical procedure
* obesity BMI\>32kg/m2
Predictability of the Effects of Facet Joint Infiltration in the Degenerate Lumbar Spine When Assessing MRI Scans

Fifty MRI scans of patients with chronic lumbar back pain were graded radiologically using a wide range of classification and measurement systems. The reported effect of facet joint injections at the site was recorded and a comparative analysis performed.


Eligibility Criteria:
Inclusion Criteria:

* patients who had received inpatient gradual diagnostics for chronic lumbar back pain
* monosegmental facet joint infiltration on the first day of inpatient gradual diagnostics
* clearly stated pain relief in percentage (%) for that specific infiltration in the medical documentation
* pain level prior to infiltration needed to be clearly documented
* a high-quality MRI available before infiltration.

Exclusion Criteria:

* ositive history of lumbar surgery or the presence of artificial implants in the area of interest
Telerehabilitation as an Alternative to Face-to-Face Rehabilitation After Total Hip Arthroplasty

The goal of this clinical trial is to learn if telerehabilitation in patients who had undergone total hip arthroplasty. The main questions it aims to answer are:

* Does telerehabilitation improve the functional level of the participants?
* Does telerehabilitation improve the locomotor performance of the participants? Researchers will compare telerehabilitation to face to face rehabilitation (traditional rehabilitation programme) to see if telerehabilitation works in total hip arthroplasty recovery.

Participants will:

* Attend physiotherapy and rehabilitation sessions supervised by a physiotherapist 2 days a week for 8 weeks.
* Participate in assessments (before surgery and at 6 weeks and 12 weeks after surgery).


Eligibility Criteria:
Inclusion Criteria:

* Having hip arthroplasty surgery
* To be able to understand verbal and written information
* No cognitive impairment
* To be able to speak and understand Turkish

Exclusion Criteria:

* Having a neurological disease
* Having a psychiatric disorder
* Visual or hearing loss that cannot be corrected with any assistive device
Promoting the Psychological Health of Women With SCI: A Virtual World Intervention

The purpose of this project is to test the efficacy of an internet-based psychological health enhancement program for women with spinal cord injury. The intervention will occur in Second Life (SL), which is an online virtual word simulator with a group of women with spinal cord injury.


Eligibility Criteria:
Inclusion Criteria:

* have a traumatic spinal cord injury
* be at least one year post injury
* be able to speak and read English (to participate in the group intervention and complete study questionnaires in English).
* have access to a phone, an email account, and a computer and high-speed Internet connection that meets minimum SL computing requirements.

Exclusion Criteria:

* have a cognitive impairment that significantly limits their ability to give informed consent, participate in the intervention, or complete study assessments as determined by an inability to correctly answer questions on a comprehension of consent questionnaire
* have a significant visual or hearing impairment that would prohibit their ability to participate in the virtual intervention
* report active suicidality
* live in institutions. Individuals living in community-based group and adult foster homes will be invited to participate.
Telemonitoring in Home Mechanical Ventilation

Multicentric, observational and longitudinal prospective evaluation of build-in-software data telemonitoring of home ventilators in patients using Home Mechanical Ventilation in Belgium.

OBJECTIVES : Use of a decisional algorithm (developed by La Citadelle/Liège) to assess Telemonitoring (AirView type, ResMed) of data in the ventilators of patients using Home Mechanical Ventilation (HMV), and registered in the Belgian agreement for HMV at 1/ the Citadelle hospital in Liège and 2/HUB-Erasme, Brussels, Belgium.

BACKGROUND: HMV initiated in the hospital is used at home. Patients who benefit from HMV present significant functional limitations of cardio-respiratory, neurological and/or physical origin. Such limitations compromise the ability of patients to travel to the referring hospital. As a result, good treatment follow-up is difficult to assess both from quantity and quality points of view. This is why Telemonitoring systems have been developed to access ventilator build-in-software data at through dedicated online systems. In other words, data from devices operating at home can be sent to the hospital and analyzed in real time by professionnals in the hospital. This project aims to evaluate the impact of Telemonitoring ventilator's data on the quality of HMV-monitoring in patients living and using HMV at home.

METHODS: A one-year multicentric, observational, longitudinal and prospective evaluation of build-in-software data telemonitoring of home ventilators in patients using HMV in Belgium. The two Belgian hospitals will each follow 10 patients for one year (2024). The data from the ventilator as well as the actions to be taken in response to Airview Telemonitoring alerts will be carried out using a decision-making algorithm created by the Citadelle Hospital in Liège.

Eligibility Criteria:
Inclusion Criteria:

* All patients starting HMV in 2024, followed up in 1/ Liège or 2/ Brussels, and using devices from the ResMed company (Astral 150 ou Lumis 150).

Exclusion Criteria:

* Individuals refusing to sign the consent form
* Presence of acute pathology requiring hospitalization and close monitoring of ventilation
* Patients using a tracheostomy
The Safety and Immunogenicity Research of Live Attenuated Varicella Vaccine After the 2 Doses Vaccination

Through evaluating the immunogenicity and safety for Varicella vaccine two doses immune procedure we could supply scientific and practical evidence for this two doses immune procedure promotion and management.

Healthy participants aged 1 to 12 years old who had never received Varicella Vaccine are divided into three age groups, 1 to 3 years old group, 4 to 6 years old group and 7-12 years old group. In each age group, participants are randomly divided into experiment group and control groups.

Eligibility Criteria:
Inclusion Criteria:

-Participants from Shanxi province are between 1-12 years old are in good healthy determined through medical inquiry, physical examination, clinical judgment of the investor.

Exclusion Criteria:

1. Having a fever (axillary temperature\>37.0℃) before enrollment;
2. Having a disease history of seizures, brain disease and the vaccination history of allergies and convulsions;
3. Antibiotics allergy;
4. Having a problem of intramuscular injection because thrombocytopenia or other blood coagulation disorder;
5. Having immunodeficiency or under immunosuppression therapy, radiation therapy;
6. Having respiratory diseases, acute infection, chronic disease and HIV infection;
7. Having systemic skin rash, skin tinea, herpes;
8. Chronic liver and kidney disease;
9. Heart disease, and severe hypertension;
10. Have received whole blood, plasma or immunoglobulin therapy 3 months before enrollment;
11. Have received other live attenuated vaccine vaccination in 30 days before enrollment;
12. Had been infected with Varicella virus and displayed symptom;
13. Have received one or two dose of Varicella vaccine before enrollment;
14. Congenital malformations, growth disorders such as Down's syndrome, diabetes, sickle cell anemia and nervous disorders
15. Guillain-barre syndrome
16. Thyroid resection history or thyroid disease treatment in the past 12 months;
17. Asthma
18. Have participated in other clinical research;
19. Have serious adverse reactions after vaccination, such as allergies, hives, breathing difficulties, angioneurotic edema.
i-Minds Professional Stakeholders Qualitative Study

The main aim of this study is to understand healthcare professionals' perceptions, as well as the barriers and enablers (and unintended consequences), relevant to the uptake of the digital intervention and its future integration into existing NHS infrastructure. We will use a qualitative study design and utilise semi-structured interviews and focus groups to gather the views and opinions from up to 30 healthcare professionals who work with young people to provide mental health and / or sexual assault care across two sites: Greater Manchester, UK and Edinburgh, Scotland.


Eligibility Criteria:
Inclusion Criteria:

* Participants will be up to 30 healthcare professionals who work within NHS services that provide mental health and / or sexual assault support to young people (for example, Child and Adolescent Mental Health Services (CAMHS) and Sexual Assault Referral Centres (SARC)) or organisations that provide digital mental health support to young people (e.g. Kooth).

Exclusion Criteria:

* None
The Diagnostic Value of Staging Laparoscopy and Computed Tomography Response Assessment in Patients With Gastric Adenocarcinoma

SUMMARY

Rationale: Diagnostic laparoscopy (DL) and response assessment after neoadjuvant chemotherapy with computed tomography (CT) are two diagnostic modalities used to assess metastatic spread in gastric cancer patients. It is still unclear in what proportion of patients clinically relevant metastases or other significant findings (e.g. contra-indications of surgery) are detected that impact on the treatment.

Objective: To determine the clinical value of diagnostic laparoscopy and computed tomography response assessment after neoadjuvant chemotherapy in patients with gastric and esophagogastric junction adenocarcinoma.

Study design: Multicentre retrospective cohort study.

Study population: All Patients with gastric and gastro-oesophageal adenocarcinoma who underwent clinical staging and were discussed at multidisciplinary team meetings (MDT) between January 2016 and December 2018.

Intervention (if applicable): Not applicable.

Main study parameters/endpoints: The main study parameter is the proportion (%) of patients who do not proceed with treatment as planned after a DL and CT response assessment (i.e. the proportion of patients in which metastasized disease or other contra-indications for surgery is found).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Since this is an observational study, no burden or risks are associated with participation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically proven gastric and esophagogastric junction adenocarcinoma.
* Patients who have had (either) DLS and/or CT response assessment (after chemotherapy).
* Discussed at MDT from January 2016 - December 2018
* ≥18 years

Exclusion Criteria:

* Patients with esophagogastric junction adenocarcinoma with the tumour bulk located in the oesophagus that receive neoadjuvant chemoradiation;
* Patients with recurrent/residual disease after earlier treatment of gastric cancer.
Transcranial Doppler Ultrasonography and Brain Death

In France the diagnosis of brain death relies on electroencephalography (EEG) or cerebral angiography. Concerning the latter a time of 6 hours is mandatory between the clinical diagnosis and the realization of the cerebral computed tomography (CT) angiography. Transcranial doppler (TCD) is not recommended in the french guidelines for the diagnosis of brain death. In other countries, some flow patterns allow to confirm the diagnosis of brain death. The hypothesis of our study is that TCD could shorten the time between the clinical diagnosis of brain death and the realization of the CT angiography.


Eligibility Criteria:
Inclusion Criteria:

* brain death patients

Exclusion Criteria:

* craniectomy
* post anoxia encephalopathy
* no TCD performed before the clinical diagnosis of brain death
* transtemporal approach impossible
The Effects of Elmore Oil on Patients With Osteoarthritis

The treatment of osteoarthritis, a disease that eventually affects the majority of the older population, involves the alleviation of symptoms such as pain and stiffness, and the reduction of inflammation. A double-blind, placebo-controlled, crossover study will be performed to examine the effect of topical application of Elmore Oil, a herbal remedy (containing Eucalyptus oil, Tea tree oil, Olive oil and Vanilla), which has recently been reported to have anti-inflammatory properties, on the symptoms of osteoarthritis.

Sixty patients were randomly selected and approved for the study, 30 patients with even numbers received the blue dotted Elmore oil and 30 patients with odd numbers got the orange dotted Elmore and were advised to apply 3x daily on the affected knees respectively for four weeks. On the fifth week, they stopped application for 7 days as flush out period. Then on the 6th week a cross over was done on the patients - the blue dotted patients, this time received the orange dotted Elmore Oil and vice-versa and did the application three times daily for another 4 weeks. All throughout the usage, they filled out their diaries (noting the degree of pain, feeling of well being (improved sleep, mobility, ability to do their daily activities at home or at work). A pre-application base line laboratory tests were done, after 4 weeks and after 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed osteoarthritis based on the criteria developed by the American College of Rheumatology.

Exclusion Criteria:

* Using other forms of topical pain relief.
Stereotype Threat Effect on CPR Performance in Covid-19 Intensive Care Units: A Randomised Controlled Mannequin Study

Stereotype threat (ST) is an important issue that has been studied repeatedly in the psychology literature. ST is the thought that a person will be negatively evaluated and judged regarding a negative stereotype that belongs to the group to which he/she belongs. Most people are members of a social group associated with at least one negative stereotype. Therefore, many people in society may be the target of stereotype threat. Previous research has shown that the individual performance of people in groups identified with negative stereotypes, who are exposed to stereotype threat, decreases. The ST may arise when there is an environment in which the skills of the person that may be affected by a stereotype associated with his/her group can be measured, or if this stereotype has become evident.

In Covid-19, there has been a rapid increase in the number of intensive care patients in our country and around the World. Due to this rapid increase, the number of intensivist physicians is insufficient, and non-intensivist physicians from various branches are assigned to intensive care units. In social media and newspaper reports, it was stated that non-intensivist physicians have insufficient knowledge and skills in intubation and in the treatment of lung infection, and the public was asked to take precautions. However, these physicians were expected to treat lung infections and intubate the patients in intensive care units during pandemics. It is unknown to what extent such negative stereotypes, established or already existing, affect the performance of non-intensivist physicians during their appointment to the intensive care units during the pandemic.

As in all other departments, the most basic task expected from doctors in intensive care units is effective basic life support applied for the treatment of cardiopulmonary arrest. Cardiopulmonary resuscitation (CPR) is a basic life support model that is mandatory taught in medical schools. For this reason, it is expected that all doctors, regardless of their specialties, will be able to perform CPR effectively. The use of manikins is quite common in order to standardize CPR training and performance measurement. The aim of this study is to evaluate how non-intensivist physicians assigned to intensive care units during the pandemic are affected by stereotype threat and to investigate the necessary conditions to prevent a possible decrease in performance in these physicians.


Eligibility Criteria:
Inclusion Criteria:

1- To have worked in the Covid-19 intensive care unit during the pandemic

Exclusion Criteria:

1. Not meeting the above criteria
2. Not willing to participate in the study
A Study of MHB039A for Advanced Solid Tumor

Phase I/II open label, multicenter study to evaluate the efficacy and safety of MHB039A in advanced malignant tumors.

This first-in-human, dose escalation and dose expansion study is to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of MHB039A in patients with advanced solid tumor. The Phase I stage （dose escalation）is to determine the maximum tolerated dose (MTD). The phase II stage （dose expansion）is to determine the recommended Phase 2 dose (RP2D) according to safety and efficacy in specific tumor types.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented advanced or metastatic solid tumor that is refractory/relapsed to standard therapies, or for which no effective standard therapy is available, or the subject refuses standard therapy.
* Written and signed informed consent
* Aged 18 years or older
* Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
* Life expectancy \>=3 months

Exclusion Criteria:

* Prior malignancy active within the previous 5 years except for the tumor for which a subject is enrolled in the study, and locally curable cancers that have been apparently cured, (e.g. basal cell skin cancer, or carcinoma in situ of the cervix or others)
* Receiving any chemotherapy within 3 weeks prior to the first dose；or other systemic anticancer therapy within 4 weeks prior to the first dose
* Receiving prior anti-PD-1, anti-PD-L1, anti-CTLA(cytotoxic T-lymphocyte-associated protein)-4 or any other immunotherapy or immune-oncology (IO) agent within 28 days of first dose with MHB039A or experienced a toxicity that led to permanent discontinuation of prior immunotherapy
* Unresolved toxicities from prior anticancer therapy
Engage Psychosocial Intervention for Cancer Symptoms

The goal of this clinical trial is to test the efficacy a new psychosocial symptom management intervention called ENGAGE for patients with Stage IV breast, prostate, lung, or colorectal cancer. Participants will be randomized to ENGAGE or a Supportive Care intervention. Patient-reported outcomes will be assessed at baseline, 2 months, and 4 months.

Pain, fatigue, and distress are highly prevalent, co-occurring, and interfering symptoms in patients with advanced cancer. This trial will test a brief telehealth delivered psychosocial intervention called ENGAGE. ENGAGE aims to help patients decrease symptom interference and improve their quality of life. Patients with Stage IV cancer (breast, prostate, lung, or colorectal) and moderate-to-severe symptom interference will be randomized to ENGAGE or Supportive Care. Patient-reported outcomes will be assessed at baseline, 2 months, and 4 months. Aim 1 is to determine ENGAGE's efficacy for reducing symptom interference (primary outcome) at 2 months (primary endpoint). Aim 2 is to determine ENGAGE's efficacy for improving secondary outcomes at 2 months. Aim 3 is to test the maintenance of ENGAGE's effects on primary and secondary outcomes at 4 months. An exploratory aim seeks insights for future implementation efforts using mixed-methods data collection from patients, oncology providers, and clinic leaders.

Eligibility Criteria:
Inclusion Criteria:

* Receiving cancer care at a Duke Cancer Network (DCN) clinic
* Oncologist confirmed Stage IV breast, prostate, lung, or colorectal cancer
* Worst pain, fatigue, or distress rated at \>/= 3 out of 10 in the past 7 days for at least 2 symptoms
* MD Anderson Symptom Inventory (MDASI) Interference with Daily Living Scale average score of \>/= 3 out of 10 in the past 7 days
* Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower
* At least 18 years old
* Ability to speak and read English
* Hearing and vision that allows for successful completion of telehealth sessions

Exclusion Criteria:

* Significant cognitive impairment indicated in medical chart or during telephone screening on a mental status questionnaire
* Serious psychiatric condition (e.g., schizophrenia, suicidal intent) that would contraindicate safe study participation
* Participation in the last 6 months in Cognitive-Behavioral Therapy or Acceptance and Commitment Therapy for cancer symptom management
* Enrollment in hospice at screening