cyrilzakka/clinical-trials huggingface dataset:
The Effect of Tranexamic Acid (TXA) on Visualization During Shoulder Arthroscopy

Tranexamic acid has seen an increase in use over the past decade in hip and knee arthroplasty as well as spine surgery with more recent use seen in total shoulder arthroplasty (TSA). The mechanism of action of TXA is as a lysine analogue that competitively inhibits the conversion of plasminogen to plasmin thus resulting in its antifibrinolytic activity. Investigators have showed that compared with placebo TXA had a statistically significant effect on blood and postoperative hemoglobin levels in TSA. To date there are no studies investigating the effect of TXA in arthroscopy of any kind or studies examining the ability of TXA to aid in surgeon visualization in arthroscopic procedures. The investigators of this study will use change in pump pressure as a surrogate objective measure for surgeon visualization. The hypothesis is that participants who receive TXA will have a lower change in pump pressure compared to participants who do not receive TXA.


Eligibility Criteria:
Inclusion Criteria:

* participants aged 18-80
* participants with an ASA (American Society of Anesthesiologists) score 1-3
* participants with a surgical indication of full thickness small to massive rotator cuff tear.

Exclusion Criteria:

* pregnant females,
* participants with a known allergy to tranexamic acid,
* participants with active thromboembolic disease,
* participants with seizure disorder,
* participants with prior cerebrovascular accident (CVA),
* history of cardiac stents or past history of thromboembolic disease,
* presence of full-thickness subscapularis tear (\>50%),
* participants with irreparable rotator cuff tears.
BIIR Gene to Manage Heart Allograft Patients

This is a single center observational study. Duration of the study is 1 year. Participants will be followed in 2 groups. Group 1 will include all patients who have undergone a heart transplant, through the first year post transplant. Group 2 will include heart transplant recipients from 1 year to 2 years post transplant. Groups will be enrolled simultaneously. It is anticipated each group will have 25 participants.

Application of the BIIR gene expression profile approach to heart transplantation clinical diagnostic issues is likely to create new means to detect rejection at the earliest stages, to help prevent progression through earlier treatment, to discover new avenues targets for treatment of heart graft rejection, and to reduce the cost of post-transplant health care

Eligibility Criteria:
Inclusion Criteria:

* Patients who will have or have already received a heart transplant.
* Patients who have no other transplant history.
* Men and Women ages 18 to 73

Exclusion Criteria:

* Patients who are pregnant or lactating will not be eligible for this protocol.
* Patients who are cognitively impaired
PREVENT Tool Study: Late Effects Clinic

The purpose of this study is to test the feasibility of a novel, Health Information Technology behavior change tool in a single clinic setting. The PREVENT tool is the first electronic health record (EHR)-compatible tool that both tailors evidence-based behavior change strategies and incorporates community-level data specific to each patient into routine care. The central hypothesis is that PREVENT will improve patient's attitudes towards behavior change recommendations, increase adherence to recommended behavior change and improve cardiovascular health. Fifty adolescents will be randomized to intervention or wait-list, routine care control to assess the preliminary effectiveness of PREVENT. Qualitative and quantitative methods will be used among patients, parents and providers to examine barriers to current and future implementation of the PREVENT tool to inform adoption and maintenance.


Eligibility Criteria:
Inclusion Criteria:

Patient Eligibility Criteria:

* Adolescents 12 to 19 years
* Prior diagnosis of pediatric cancer (diagnosed \<21 years of age)
* Not receiving active therapy for their cancer
* Receiving care from the Pediatric Hematology/Oncology staff and physicians at St. Louis Children's Hospital or the St. Louis Children's Specialty Care Center (CSCC)
* At risk for poor cardiovascular health (CVH) (BMI greater than or equal to 85th percentile)

Provider Eligibility Criteria -All providers and staff (physicians, nurses, clinic staff, clinical research associates) in the Pediatric Hematology/Oncology program at St. Louis Children's Hospital and the CSCC

Parent Eligibility Criteria

-A parent or legal guardian of a study participant. The parent or legal guardian must have been present at the clinic visit in which the PREVENT tool was administered to the study participant.
Telematic Dance Intervention on Quality of Life of Older

The aim of this study is to analyse the effectiveness of a telematic dance intervention on the quality of life of older people.

This project is a controlled, randomized clinical trial. 54 people (Intervention Group, n=27; Control Group, n=27) between the ages of 60-80 will participate in the study.

Intervention Group participants will perform a 3-month telematic dance program based on choreographic work. The participants shall be measured 3 times, at baseline, post-intervention, and at 6-month post-intervention follow-up. Aside from the quality of life, variables of balance, risk of falling, number of falls, level of physical activity, mood, functionality, comorbidity, and quadriceps strength will also be measured.


Eligibility Criteria:
Inclusion Criteria:

* Aged 60-80.
* Owning a device that can connect to internet to visualize videos and do videocalls, in case a session to resolve doubts is necessary.

Exclusion Criteria:

* Subjects with degenerative or cognitive pathologies
* Subjects with severe visual deficiencies.
* Subjects with any acute pain.
* Subjects with inability to stand.
* Subjects with any medical contraindication to exercise (cardiovascular risk factors).
* Subjects incapable of managing telematic devices to follow the sessions.
* Subjects who refuse to sign the informed consent.
Evaluation of a Workplace Smoking Cessation Program in Hong Kong (Phase VI)

This study aims to test, by a 2-arm RCT, the effectiveness of an intervention that includes mobile phone-supported simple physical exercise for smoking cessation in workplaces in Hong Kong.


Eligibility Criteria:
Inclusion Criteria:

1. Hong Kong residents aged 18 or above
2. Smoke at least 1 cigarette per day or use other tobacco products (EC, HTP and others) daily
3. Able to communicate in Cantonese/Mandarin and read Chinese
4. Able to use instant messaging tools (e.g. WhatsApp) for communication
5. Stay in Hong Kong during the intervention and follow-up periods (12 months)

Exclusion Criteria:

1. Smokers who are psychologically or physically unable to communicate
2. Currently joining other smoking cessation program(s)
3. Smokers who cannot tolerate the proposed exercise program
4. Smokers who have severe mental illnesses
Clinical Utility of Selected Circulating Tumor DNA Assays in Patients With Advanced Malignancy

Circulating tumor DNA assays are becoming relevant for routine diagnostics, but many related aspects are yet unresolved. With this project, the investigators aim to develop pragmatic molecular diagnostic pathways of liquid biopsies relevant in advanced gastrointestinal malignancies with focus on clinical utility and sensible use of resources. They want to evaluate the ctDNA assays on a fully automated "low-cost" multiplex platform which is already implemented in routine molecular diagnostics of solid biopsies. The project will evaluate to what extent these ctDNA assays are relevant for clinical decision-making.

Advanced pancreatic cancer (PDAC) and cholangiocarcinoma (CCA): -Could the Idylla ctKRAS test select the \~10% of PDAC patients with KRASwt eligible for more extensive diagnostics? In PDAC and CCA, is it possible to detect patient samples with KRAS G12C or BRAF mutation for study inclusion? Could the ΔCq-value of the tests be used as a semi-quantitative tumor marker? What is the clinical value compared to the current tumor marker CA19-9?

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Metastatic Colorectal Cancer: Are the ctDNA assays useful in detecting primary resistance and/or monitoring for secondary/acquired resistance to EGFR antibody treatment? How does the sensitivity, specificity and turnaround time of the ctDNA assays compare to tissue-based analysis? Could the Idylla ctDNA assays accelerate detection of KRAS G12C or BRAF mutations, and hence facilitate study inclusion in the first line setting? Could the ctDNA assays guide rechallenge with EGFR treatment?

Can the information of liver metastases or prognostic markers (s-CEA, s-CRP) guide timing of ctDNA sampling?

Eligibility Criteria:
Inclusion Criteria:

Newly referred patients with advanced pancreatic cancer (\~20/year), Cholangiocarcinoma (\~20/year), metastatic colorectal cancer (mCRC) (\~50/year) and anti-EGFR-treated mCRC patients (\~10/year) to Oslo University Hospital are eligible for inclusion.
A Study Exploring Two Strategies of Rivaroxaban (JNJ39039039; BAY-59-7939) and One of Oral Vitamin K Antagonist in Patients With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention

The primary purpose of this study is to evaluate the safety for 2 different rivaroxaban treatment strategies and one Vitamin K Antagonist (VKA) treatment strategy utilizing various combinations of dual antiplatelet therapy (DAPT) or low-dose aspirin (ASA) or clopidogrel (or prasugrel or ticagrelor).

This is an open-label (both physician and participant know the treatment that the participant receives), randomized (study medication is assigned by chance), multicenter clinical study assessing the safety of 2 rivaroxaban treatment strategies and one vitamin K antagonist (VKA) treatment strategy in participants, who have paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF) and have had a percutaneous coronary intervention (PCI) with stent placement.

A target of 2,100 participants will be randomized into the study, with approximately 700 participants in each treatment strategy group. The randomization will be stratified by the intended duration of DAPT (1, 6, or 12 months).

The study consists of a screening phase, a 12-month open-label treatment phase, and an end-of-treatment/early withdrawal visit. The total duration of participation in the study for each participant is approximately 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Have a documented medical history of paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF)
* Have undergone percutaneous coronary intervention (PCI) procedure (with stent placement) for primary atherosclerotic disease
* Must have an international normalized ratio (INR) of 2.5 or below to be randomized
* Women must be postmenopausal before entry or practicing a highly effective method of birth control when heterosexually active
* Be willing and able to adhere to the prohibitions and restrictions specified in the study protocol

Exclusion Criteria:

* Have any condition that contraindicates anticoagulant or antiplatelet therapy or would have an unacceptable risk of bleeding, such as, but not limited to: platelet count \<90,000/microliter at screening, history of intracranial hemorrhage, 12 month history of clinically significant gastrointestinal bleeding, non-VKA induced elevated prothrombin time (PT) at screening
* Have anemia of unknown cause with a hemoglobin level \<10 g/dL (\<6.21 mmol/L)
* Have a history of stroke or Transient Ischemic Attack (TIA)
* Have a calculated Creatinine Clearance (CrCl) \<30 mL/min at screening
* Have known significant liver disease or liver function test (LFT) abnormalities
* Have any severe condition that would limit life expectancy to less than 12 months
The Relationship Between Physical Activity Level and Fear of Birth (Tokophobia) in Pregnant Women

The aim of this study is to determine the effects of physical activity on fear of childbirth (tokophobia) in pregnant women.

Fear of childbirth is defined as the fear felt and experienced before, during and after birth. Fear of childbirth is an acceptable level of fear and motivates the woman to prepare for the birth. However, if the fear developed before pregnancy and/or the severity of the fear increased during pregnancy, this situation is called "Tokophobia".

Physical activity is defined as body movements that are performed by using the body's muscles and joints, require energy expenditure above the basal level, can be performed at different intensities, increase heart rate and respiration, and occur with the contraction of large muscle groups.

It has been shown in the literature that physical activity in pregnant women contributes to the health of both the mother and the infant.

Several studies have reported the benefits of physical activity and exercise in preventing many risks of pregnancy, including lowering the risks of excess weight gain, preeclampsia, gestational diabetes, gestational hypertension, prenatal depression and macrosomia, and improving psychological well-being.

Despite the reported benefits of regular physical activity in the literature, it has been reported that the level of physical activity during pregnancy is lower compared to the pre-pregnancy period.

Eligibility Criteria:
Inclusion Criteria:

Having difficulty in communicating in order to understand and answer the evaluation questions correctly, Being at 14-40 weeks of gestation, Pregnancies with regular perinatal control.

Exclusion Criteria:

Being chronically ill or obese Individuals with a history of orthopedic, neurological, rheumatological or cardiopulmonary disease or surgery, Having 2 or more miscarriages, Multiple pregnancy, High-risk pregnancy Continuous vaginal bleeding Pre-pregnancy Body Mass Index (BMI) less than 17.5.
Impact of Crew Resource Management Training to Improve the Effectiveness of Surgical Safety Checklist (IDILIC)

This multicenter cluster-randomized trial will evaluate the impact of Crew Resource Management training on the occurrence of postoperative complications and the adherence to a surgical safety checklist, among a large sample of French surgical departments.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Hospitalization ≥ 24 hours
* Available medical file

Exclusion Criteria:

* Patient refusal
Comparative Real World Effectiveness of SQ Sublingual Immunotherapy (SLIT)-Tablets vs. Controls in Allergic Rhinitis and Asthma

To assess the impact of SQ SLIT-tablets (SQ Grass SLIT-tablet and SQ HDM SLIT-tablet) in Danish and Swedish allergic rhinitis (AR) patients, with or without asthma, between 2007-2020.

Allergic rhinitis (AR) is an inflammatory disorder, characterised by pruritus, sneezing, rhinorrhoea, and nasal congestion. It is one of the most common disorders worldwide, with an estimated global prevalence of 10-30%. AR is a chronic and progressive disease, as the underlying respiratory allergy can progress into allergic asthma. The prevalence of asthma in patients with AR is high and estimated between 10-40%. The presence of AR commonly exacerbates asthma, increasing the risk of asthma exacerbations, emergency visits and hospitalisations for asthma.

Recently, the high-quality retrospective cohort REACT study (ClinicalTrial.gov: NCT04125888) found that allergy immunotherapy (AIT) was associated with long-term reduction in AR medication use as well as significant reductions in both controller and reliever asthma medication and concurrent lower risk of asthma exacerbation and pneumonia in subjects with pre-existing asthma. The SQ sublingual immunotherapy (SLIT)-tablets have robust evidence from randomised controlled trials (RCTs), but real-world evidence (RWE) is needed to complement the findings from RCTs by looking at e.g. longer time horizons and broader patient populations. As the REACT study was not designed to specifically look at evidence-based AIT treatments like the SQ SLIT-tablets, the real-world effectiveness of SQ SLIT tablets remain to be further elucidated.

Eligibility Criteria:
Inclusion Criteria:

AR-patients identified by dispensations of prescribed AR medications and/or ICD10-codes of AR in specialty care

For the SQ SLIT-tablet cohort:

- at least 2 dispensings within 365 days of SQ SLIT-tablets (ATC: V01AA02 and V01AA03)

For the control cohort:

- unexposed subjects will be identified from the study population of AR-patients that may be eligible to receive SQ SLIT-tablets, but have not dispensed a prescription of SQ SLIT-tablets during the index year of the case or prior to that year

Exclusion Criteria:

- allergy immunotherapy treatment with grass or HDM allergens prior to the index event
Diagnostic Research in Patients With Rare Diseases - Solving the Unsolved Rare Diseases

The DiRiP study will enroll patients (n = 3500) with unclear rare diseases and suspected genetic reasons. In group 1 (n = 500) subjects are clinically characterized in the context of outpatient/ inpatient standard care at the UKT or cooperating location, NGS analyzes and other omics analyzes (transcriptomics, proteomics, metabolomics), functional cell biology studies will be performed. In group 2 diagnostics is already performed.

The DiRiP-study fully integrates with the newly formed European Reference Networks (ERNs) for rare diseases, and in particular the ERN-RND, -EURO-NMD, -ITHACA, and -GENTURIS.

In the DiRiP-RD study (monocentric, prospective, open-label diagnostic study), patients with genetically unexplained diseases will be analyzed or re-analyzed from existing datasets for further omics analysis. These are evaluated with regard to the following questions:

Primary:

* Verification of the genetic causes of unclear genetic diseases

Secondary:

* Improve number of diagnoses of unclear syndromes
* Further characterization of the identified gene defects
* Number of patients receiving appropriate therapy after successful diagnosis. In addition, patient phenotype and genotype data can be collected using a software tool for collecting and analyzing phenotypic information of patients with genetic disorders ( PhenoTips®) software to facilitate data exchange within the UKT, with external collaborators and data transfer to the Solve-RD project.

Eligibility Criteria:
Inclusion Criteria:

* Unclear diagnosis
* Suspected genetic cause of the disease

Exclusion Criteria:

* Missing informed consent of the patient/ legal guardian
Safety and Efficacy of PF-04217329 in Patients With Glaucoma or Elevated Eye Pressure.

To evaluate the safety and efficacy of PF-04217329.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary open-angle glaucoma (including pigmentary or pseudoexfoliative) or ocular hypertension in 1 or both eyes.
* Qualifying intraocular pressure (IOP) in the same eye at the Eligibility 1 and 2 measurements.

Exclusion Criteria:

* Closed/barely open anterior chamber angle or a history of acute angle closure in either eye.
* Anticipate the need to initiate or modify medication (systemic or topical) that is known to affect intraocular pressure (IOP) during the study period.
Artificial Intelligence in Lung Ultrasound for Preeclampsia

A total of eight quadrants of standard lung US examination was performed to all pregnant women with preeclampsia within the scope of the study by the same anesthesiologist, dividing each hemithorax into four regions through the parasternal, anterior axillary, posterior axillary vertical lines, and the horizontal line assumed to pass under the nipple. The resulting images were stored in digital media. A Lung US examination was performed once for an average of 5-10 minutes. The presence of B lines was investigated in the examination.

The case was defined as interstitial edema when the B lines, which are defined as vertical linear hyperechoic reverberation artifacts representing the edematous interlobular septa/alveoli, extend posteriorly from below the pleural line and moving in sync with lung movements, are found in two or more lung areas. B-lines were determined for each case and reported in standard form in terms of number and morphology. The diagnostic accuracy of B lines was determined with the artificial intelligence supported SmartAlpha Rievi 1300 software program. B-lines validated by artificial intelligence assisted algorithm in all stored digital images were reported blindly by another anesthesiologist experienced in lung US. The clinical features, laboratory parameters, and intraoperative hemodynamic data of the cases were recorded to be evaluated in terms of relationship with lung US data.

We predict that the application of lung US with artificial intelligence software will provide an opportunity to quickly evaluate the clinic of preeclamptic pregnant women who are frequently operated on in emergency conditions.

After ethics committee approval, standard lung ultrasound (US) examination in eight quadrants was performed to search presence of B lines in 35 ASA III-IV parturients with preeclampsia by the same anesthesiologist. Interstitial edema was defined by recognition of the B lines in two or more lung regions. The digital images of B-lines verified with artificial intelligence (AI) were evaluated blindly by another anesthesiologist experienced in lung US.

After assigning preeclamptic patients as mild or severe; demographic, hemodynamic and labarotary results were compared. Then, lung US findings (A pattern, 3 B lines and 1 or 2 B lines) were documented. Additionally, amount of protein / 24 hr, amount of fluid infusion (crystalloid or colloid) and hemodynamic parameters acording to lung US findings were compared.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who underwent cesarean section with a diagnosis of preeclampsia

Exclusion Criteria:

* Preeclamptic parturients who have another lung disease
* Preeclamptic parturients whose optimal lung US image could not be obtained
Safety and Efficacy Study Using 5-ALA Oral Administration as an Adjuvant Therapy on the Rate of Local Tumor Recurrence in Patients Who Have Desmoids Tumors

The purpose of this study is to evaluate the efficacy of preoperative 5-ALA oral administration and subsequently intraoperative tumor bed phototherapy with red light laser, as an adjuvant therapy on the 3 years rate of local tumor recurrence in patients with desmoid tumors. To evaluate the Safety of 5-ALA administration. 5 years local recurrence rate.


Eligibility Criteria:
Inclusion Criteria:

1. Patient has a resectable histologically confirmed desmoid tumor.
2. Previously treated (by chemotherapy, irradiation or surgery) patients are eligible.
3. Age \> 18 years
4. Signed informed consent prior to patient recruitment. -

Exclusion Criteria:

1. Hepatic enzymes or bilirubin \> 2X upper limit of normal.
2. Serum creatinine \> 2.5 x upper limit of normal.
3. Suspected /documented metastatic disease.
4. Active or uncontrolled infections.
5. Active second malignant disease (excluding non-melanoma skin cancer, or in situ cervix or breast carcinoma) \< 2 years prior to the study.
6. Use of other investigational agents \< 30 days prior to the study.
7. Patients who are mentally or physically unable to comply with all aspects of the study.
8. Any serious medical condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he or she participates in this study or confounds the experimental ability to interpret data from the study.
9. Pregnant or lactating females.
10. Known intolerance or allergy to 5-ALA
11. Suspicious or documented acute or chronic porphyria