cyrilzakka/clinical-trials huggingface dataset:
The Value of End-tidal Capnography in Gastrointestinal Bleeding

Gastrointestinal bleeding is a condition that frequently presents to emergency departments and can be fatal if diagnosis and treatment are delayed. The working mechanism of end tidal capnography is simply to detect the respiratory carbon dioxide level.

In our study, the investigators aimed to determine the severity of gastrointestinal bleeding by using the Glaskow Blachford Score and AIMS65 score in cases presenting with gastrointestinal bleeding, to determine the end tidal carbon dioxide value by capnography in these cases and to determine its effectiveness in evaluating mortality and morbidity in gastrointestinal bleeding.

Gastrointestinal (GI) bleeding is a condition that frequently presents to emergency departments and has a mortal course in case of delayed diagnosis and treatment. Upper GI bleeding accounts for 5% of emergency department admissions. Mortality rates vary between 2% and 15%. Mostly, GI bleeding stops spontaneously and does not require endoscopic intervention, blood transfusion or surgery. However, among patients with life-threatening bleeding, timely intervention is very important. For this purpose, there are widely used and validated risk stratification tools such as the Glasgow Blatchford Score (GBS) and the AIMS65 score.

Capnography involves the noninvasive measurement of CO2 partial pressure during the respiratory cycle. It provides information on ventilation (efficiency of carbon dioxide elimination), perfusion (vascular CO2 transport) and metabolism (CO2 production through cellular metabolism). The principle of end-tidal capnography (ETCO2) is to detect the level of carbon dioxide in the expiratory breath.ETCO2 waveform changes provide information to physicians in various situations such as assessment of disease severity, cardiac arrest (quality of compression, return of spontaneous circulation, endotracheal tube placement, prognosis) procedural sedation and prediction of critical illness.

In our study, the investigators aimed to determine the relationship of ETCO2 value with GBS and AIMS65 scores and its effectiveness on the evaluation of morbidity and mortality in patients admitted to the emergency department with GI bleeding.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting to the emergency department with symptoms and signs of gastrointestinal bleeding (hematochezia, melena, hematemesis).
* Patients with a presumptive diagnosis of gastrointestinal bleeding confirmed by endoscopy and colonoscopy.
* Patients who consent to participate in the study.
* Patients aged 18 and older.

Exclusion Criteria:

* Patients without symptoms and signs of gastrointestinal bleeding.
* Patients with a presumptive diagnosis of gastrointestinal bleeding ruled out by endoscopy and colonoscopy.
* Patients with respiratory pathologies that increase CO2 levels (such as asthma, COPD, pneumonia, etc.).
* Patients referred from external centers and underwent ERT replacement.
* Patients with heart failure.
* Patients who refuse to participate in the study.
Corneal Collagen Crosslinking With Riboflavin for Keratoconus Treatment: A Brazilian Study

Cross-linking of the cornea increases the mechanical and biochemical stability of the stromal tissue. The purpose of this study is to assess the effectiveness of riboflavin-ultraviolet light induced cross-linking of corneal collagen in improving visual acuity and reducing progression of keratoconus in the Brazilian population.


Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 35 years.
* Diagnosis of Keratoconus.
* Progression of Ametropia.
* Written informed consent.

Exclusion Criteria:

* Corneal Thickness \< 395 micra at thinnest point.
* Other active ocular disease than keratectasia.
* Cornea Guttata.
* Previous ocular surgery.
* Pregnancy.
* Known sensitivity to riboflavin.
Prospective Multi-centre Outcomes Study of Persona Knee System in Total Knee Arthroplasty

This is a prospective, multi-centre, non comparative, post market clinical follow-up study involving orthopaedic surgeons skilled in TKA and experienced implanting the devices included in this study.

The objectives of the study are to document the implant survivorship and clinical outcomes data for the Persona fixed bearing implants used in primary total knee arthroplasty (TKA). The study will include a maximum of 20 centres and up to 1000 implanted knees. Each centre may enrol up to a maximum of 100 implanted knees to permit assessment of the consistency of outcomes across a variety of investigators and clinical settings.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 80 years old, inclusive
* Qualifies for a primary TKA based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following:

  1. Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
  2. Collagen disorders and/ or avascular necrosis of femoral condyle.
  3. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
  4. Moderate valgus, varus or flexion deformities.
  5. The salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee.
* Participated in a study-related informed consent process.
* Willing and able to provide written informed consent by signing and dating the IRB/EC approved informed consent form.
* Willing and able to complete scheduled study procedures and follow-up evaluations.
* Independent of study participation, patient is a candidate for commercially available Persona fixed bearing knee system implanted in accordance with product labelling.

Exclusion Criteria:

* Currently participating in any other surgical intervention studies or pain management studies.
* Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint.
* Insufficient bone stock on femoral or tibial surfaces/
* Skeletal immaturity
* Neuropathic arthropathy
* Any loss of musculature or neuromuscular disease that compromises the affected limb.
* Stable, painless arthrodesis in a satisfactory functional position.
* Severe instability secondary to the absence of collateral ligament integrity.
* Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin.
* Known or suspected sensitivity or allergy to one or more of the implant materials.
* Pregnant or considered a member of a protected population (e.g. prisoner, mentally incompetent, etc.)
* Previously received partial or total knee arthroplasty for the ipsilateral knee.
Comparison of Chlorpromazine or Pentobarbital Premedications for Pediatric Imaging Procedures

Sedation is often required for pediatric medical imaging procedures to ensure compliance and quality images. Recommendations exist regarding pediatric sedation, but there are currently no guidelines regarding the choice of the sedative drug. We aim to compare the efficacy and adverse events of per os pentobarbital with intravenous chlorpromazine in children undergoing diagnostic imaging procedures.


Eligibility Criteria:
Inclusion Criteria:

* Children
* Sedation for the purpose of imaging
* Sedation using chlorpromazine or pentobarbital

Exclusion Criteria:

* Refusal to participate
HIV Exposure in Utero and Metabolic Disease Risk in HIV-Negative Young Adults

Globally, over 1 million babies are born to mothers with HIV each year. With the advent of prenatal antiretroviral therapy, up to 98% of these individuals may be HIV-exposed uninfected (HEU). A growing literature suggests that in utero HIV exposure - even in the absence of subsequent infection - may be associated with adverse health outcomes in infancy and childhood. However, there is little information about the long-term health implications of in utero HIV exposure later in life, such as into adulthood. In this study, for the first time, we seek to prospectively evaluate metabolic and immune indices among HEU young adults as compared to well-matched HIV-unexposed uninfected controls. This study serves as a necessary first step toward optimizing clinical care for this expanding and aging HEU population, including the implementation of novel screening and prevention strategies.


Eligibility Criteria:
INCLUSION CRITERIA:

HIV-Exposed Uninfected (HEU) Mother-Young Adult Dyads

1. Male or female young adult, 18-35 years old
2. Documentation of HIV infection in mother with date of diagnosis preceding young adult birth date
3. Negative HIV test in young adult

Control Mother-Young Adult Dyads

1. Matching to HEU dyad
2. Negative HIV test in mother and young adult

EXCLUSION CRITERIA:

All Young Adults

1. Pregnancy within 6 months or active nursing
2. Change in blood glucose or blood pressure medication within 3 months
3. Change in estrogen or testosterone therapy within 3 months
4. Chronic glucocorticoids (except steroid inhalers or creams) within 3 months
5. Antiretroviral therapy use within 6 months (i.e., prophylaxis)
6. Significant chronic illness judged by the investigator to represent a contraindication to participation
Have a Good Grasp of the Worldthe World

Brief Summary: In schizophrenia, dislocation of psychic functions involving a loss of contact with reality is frequently found. A fragmentation of motor and sensory perceptions could be held responsible. However, automatic integration between perception and action is the necessary condition to be in "relationship with the world." Affordance is the experimental link between object perception and potentially associated actions (Gibson, 1977, 1979) explored by Stimulus Response Compatibility (SRC) paradigm. With Tucker \& Ellis sensory motor compatibility task (1998), with a modified response device (responses given with grasp), we study the impact of motor activation on these affordance effects. In this study, a group of controls will also be included in order to understand, as precisely as possible, the mechanisms involved (i.e., interference between the perception of the object and the response gesture).

Schizophrenic patients will perform: Alert TEA, (Zimmermann and Fimm, 2005), Edinburgh laterality questionnaire (Oldfield, 1971), IQ test (IQ: PM38, Raven, 1960), and the PANSS (Positive and Negative Syndrome Scale, Kay et al., 1987). Controls will only perform the laterality questionnaire. Then all will perform the affordance task, in which photographs of 20 objects of everyday life, typically graspable with one hand, are presented in 4 orientations. Participants have to respond in a graspable device, as quickly as possible, if the object is presented upright or inverted.

Eligibility Criteria:
Inclusion Criteria:

* For patients:

  * a DSM-IV diagnosis of schizophrenia (men or women),
  * no change in antipsychotic medication and clinical status within four weeks prior to the study
* For patients and control group • Age ≥ 18 years et ≤ 55 years

Exclusion Criteria:

* History of head trauma,
* neurological disease with cerebral repercussion or not stabilized serious physical illness;
* psychotropic medication
* disorders related to the use of a psychoactive substance (abuse, dependence or withdrawal);

Exclusion Criteria:

* For patients:

  • IQ \< 70
* For patients and control group

  * History of head trauma,
  * neurological disease with cerebral repercussion or not stabilized serious physical illness;
  * psychotropic medication
  * disorders related to the use of a psychoactive substance (abuse, dependence or withdrawal);
"Immunoregulation in Atherosclerosis: A Single-Cell RNA Sequencing Study"

Atherosclerosis is the leading cause of acute cardiovascular events, such as myocardial infarction and stroke, and is a significant risk factor for cardiovascular mortality. The detailed understanding of the immune mechanisms and cellular transformations involved in the pathogenesis of atherosclerosis is still limited, and the use of single-cell RNA sequencing (scRNAseq) has revealed new cellular functions and subpopulations associated with disease progression. This study aims to identify cellular subpopulations, molecular pathways, and changes in gene expression related to the development of atherosclerosis in human coronary arteries. Using scRNAseq, the study seeks to characterize the transcriptomic landscape of cells present in atherosclerotic plaques and identify molecular signatures that reveal individual predispositions to specific phenotypes, such as disease susceptibility and response to therapies. The research will be conducted at the Albert Einstein Israeli Hospital in São Paulo and will involve samples from coronary arteries and atherosclerotic plaques of the explanted hearts of patients who have undergone heart transplants as well as from discarded material of coronary artery bypass graft surgery (CABG). With an estimated sample size of 20-30 plaques, the data obtained will allow for a detailed analysis of the molecular mechanisms involved in atherosclerosis, contributing to the development of specific therapeutic targets.

This is a prospective observational study that will be conducted with samples of coronary arteries and atherosclerotic plaques from the explanted hearts of patients with ischemic cardiomyopathy who have undergone heart transplants as well as from discarded material of coronary artery bypass graft surgery . The atherosclerotic plaque samples will be retrieved from the coronary arteries during the transplant surgery or the CABG procedure and transported to the laboratory within 2 hours. The selected arteries will be dissected and microscopically evaluated, and the samples will be fixed in formalin, embedded in paraffin, and stained for histological analysis. The tissue will be enzymatically dissociated to obtain individual cells, which will then be filtered and assessed for cell viability. The cells will undergo single-cell RNA sequencing (scRNAseq) with the aim of analyzing around 5,000-10,000 cells per sample. The sample size will be 20-30 plaques, with the goal of capturing the main cellular populations and performing a robust analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with ischemic cardiomyopathy due to advanced atherosclerosis, undergoing heart transplantation;
* Patients with coronary artery disease submitted to coronary artery bypass graft surgery (CABG)."
* Aged between 40 and 75 years;
* Signed informed consent form.

Exclusion Criteria:

* Patients with systemic inflammatory or autoimmune diseases;
* History of cancer within the last 5 years or active malignancy;
* Recent use (within the last 6 months) of immunosuppressive therapy.
High Intensity Focused Ultrasound in PAtients With Varicose Veins in Singapore

The aim of the study is to evaluate the efficacy of non-invasive echotherapy for the treatment of varicose veins, within local population, using the Sonovein® device. The quality of life scores at baseline, 2 weeks, 3 months, 6 months and 12 months will be assessed using the EQ-50D, AVVQ and CIVIQ scores. Patient satisfaction at these time points will also be assessed.

Sonovein® is a unique echotherapy solution, combining therapeutic ultrasound and ultrasound for monitoring. The high-intensity ultrasound beam is focused on the vein through a magnifying glass. As thermal energy is delivered, the thermocoagulation property of ultrasound energy affects the vein wall, causing shrinking and collapsing of the target vein. Thus creating a fibrotic seal and occluding the vessel. The treated vein is immediately closed after the procedure, and its diameter will continuously reduce over time, becoming a fibrotic chord. The treatment along the vein is steered automatically via a touch screen monitor. In-beam linear ultrasound probe allows visualisation of the vein in real-time and insures optimal accuracy. The study involves prospective data collection of 30 patients that will be undergoing HIFU as choice of treatment for their varicose veins / CVI. Questionnaires will be conducted at 5 timepoints - baseline before procedure, 2 weeks, 3 months, 6 months and 12 months. Subjects will be seen at outpatient clinic post-procedure. Besides questionnaires, physical examination and duplex ultrasound scan will be conducted at 2 weeks, 3 months, 6 months and 12 months to ensure occlusion of treated vein.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>21 years, able to understand the requirements of the study and provide informed consent.
2. C2 - C5 varicose veins / CVI
3. Symptomatic primary GSV, SSV or AASV incompetence, with reflux \>0.5 seconds on colour duplex, including one or more of the following symptoms: aching, throbbing, heaviness, fatigue, pruritus, night cramps, restlessness, generalized pain or discomfort, swelling.
4. Patients who has GSV, SSV or AASV diameters of 3mm to 12mm in the standing position.

Exclusion Criteria:

1. Current DVT or history of DVT
2. Recurrent varicose veins
3. Pregnant patients
4. Arterial disease (ABPI\<0.8)
5. Sepsis
6. Patients who are unwilling to participate
7. Inability or unwillingness to complete questionnaires
8. Adverse reaction to sclerosant or cyanoacrylate
9. GSV, SSV or AASV severely tortuous
10. Life expectancy \< 1 year
11. Active treatment for malignancy other than non-melanoma skin cancer
12. Current, regular use of systemic anticoagulation (e.g. warfarin, heparin)
13. Daily use of narcotic analgesia or NSAIDS to control pain associated with venous disease
The Effectiveness of Virtual Reality Based Rehabilitation in Patients With Knee Osteoarthritis

We aimed to investigate the effects of virtual reality based rehabilitation program on patients with knee osteoarthritis.

Sixty volunteer participants with knee osteoarthritis aged 40 to 65 years who were at stage of 2-3 according to the Kellgren Lawrence radiological evaluation were included in the study.

Participants were randomly divided into two groups as virtual and control group. While a conventional physiotherapy program consisting of electrotherapy and exercise program was applied to both groups 5 days a week for 6 weeks, a virtual reality program was added to the virtual group for 6 weeks, 5 days a week. At the beginning of the treatment and at the end of the sixth week, ROM, pain, kinesiophobia, proprioception, balance, muscle strength and functional status were evaluated between groups.

Eligibility Criteria:
Inclusion Criteria:

* knee osteoarhritis aged 40 to 75 years who were at stage of 2-3 according to the Kellegren Lawrence radiological evaluation were included in the study.

Exclusion Criteria:

* Those who have received physical therapy in the last 6 months
* Having serious systemic and cardiovascular diseases that may prevent exercise
* Neurological and orthopedic problems affecting gait
* Those with sensory defects
* Malignancy diagnosed
* Those who have received PRP (Platelet-Rich Plasma) treatment or intra-articular steroid injection treatment in the last 6 months
* With metal implants
* Serious hearing loss or visual impairment
* Communication problems
Study of AZD2811 + Durvalumab in ES-SCLC

A Phase II Multicenter, Open-Label, Single Arm Study to Determine the Efficacy, Safety and Tolerability of AZD2811 and Durvalumab Combination as Maintenance Therapy After Induction with Platinum-Based Chemotherapy Combined with Durvalumab, for the First-Line Treatment of Patients with Extensive Stage Small-Cell Lung Cancer.

Primary objective of this study is to evaluate the efficacy of AZD2811 and durvalumab in patients who have not progressed following induction therapy with platinum-based chemotherapy combined with durvalumab.

This is an open-label, single arm study. Patients will be treated in an induction phase with platinum-based induction therapy and durvalumab. At the end of this induction period, participants will be assessed for disease progression, per RECIST v1.1.

Participants who have not progressed per RECIST v1.1 at the end of the induction phase will roll over into the maintenance phase of the trial, where patients will commence AZD2811 and durvalumab combination.

Participants will be treated with AZD2811 and durvalumab as maintenance therapy until confirmed progressive disease, start of non-protocol defined anticancer therapy, unacceptable toxicity, or withdrawal of consent.

If study intervention is permanently discontinued, the participant will remain in the study to be evaluated for safety assessment, as well as for confirmed disease progression and for survival.

Targeted population are adult patients (aged ≥18 years) with histologically or cytologically documented extensive disease (American Joint Committee on Cancer Stage (7th edition) IV SCLC \[T any, N any,M1 a/b\]), or T3-4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan. Patients must have WHO/ECOG performance status of 0 or 1.

Tumor assessments will be performed at Screening as baseline with follow-up every 6 weeks ± 1 week for the first 36 weeks, and then every 8 weeks ±1 week until confirmed objective disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Documented evidence of extensive stage SCLC (ES-SCLC)
* Participants must be considered suitable to receive an induction platinum-based chemotherapy regimen, combined with durvalumab, as first-line treatment for ES-SCLC
* No prior exposure to immune-mediated therapy
* Life expectancy ≥12 weeks at Day 1.
* ECOG 0 or 1 at enrolment.

Exclusion Criteria:

* Any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy
* Has a paraneoplastic syndrome (PNS) of autoimmune nature, requiring systemic treatment (systemic steroids or immunosuppressive agents) or has a clinical symptomatology suggesting worsening of PNS
* Active infection including tuberculosis, HIV, hepatitis B and C
* Active or prior documented autoimmune or inflammatory disorders
* Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.