cyrilzakka/clinical-trials huggingface dataset:
Prevention of the Hepatic Sinusoidal Obstruction Syndrome by Means of Anticoagulants

The purpose of the study is to determine whether anticoagulant use (i.e. salicylates, clopidogrel, low-molecular weight heparin, or coumarin derivates) is able to prevent the development of the sinusoidal obstruction syndrome secondary to oxaliplatin-based neoadjuvant chemotherapy in patients suffering from colorectal liver metastases.

Surgical resection remains the only curative treatment for patients suffering from colorectal liver metastases, but only 15-25% of patients are initially eligible for resection. The majority of patients suffering from colorectal liver metastases receives chemotherapy prior to liver surgery in order to downsize the colorectal liver metastases. Preoperative treatment with oxaliplatin-based chemotherapy is related to sinusoidal injury, the so-called sinusoidal obstruction syndrome. Patients with histologically proven sinusoidal injury undergoing liver surgery have a higher risk of post-resectional morbidity. Damage to the hepatic sinusoids is a key factor for the development of the sinusoidal obstruction syndrome. Anticoagulants (i.e. salicylates, clopidogrel, low-molecular weight heparin, or coumarin derivates) might be able to prevent this damage and, consequently, the development of the sinusoidal obstruction syndrome in patients suffering from colorectal liver metastases treated with neoadjuvant chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* colorectal liver metastases that are eligible for resection
* operated from January 2008 up until December 2009 at Maastricht University Medical Centre

Exclusion Criteria:

* irresectable colorectal liver metastases
Assessment of Admission to the ICU of Onco-hematological Patients.

Multicenter, observational and prospective study.

The data collection period will include 6 consecutive months, starting from the date of acceptance or conformity of the CEIC. Or, until an adequate sample size is reached that guarantees the statistical relevance of said analysis. All patients will subsequently be followed up 3 months after discharge from the ICU.

Eligibility Criteria:
Inclusion Criteria:

* Adults
* Solid organ tumor or hematological malignancy,

Exclusion Criteria:

-under 18 years old
Muscle Mass and Body Composition

ICUacquired weakness is a common complication of critical illness, particularly in patients receiving mechanical ventilation and/or suffering from conditions leading to the systemic inflammatory response syndrome.

The weakness and disability that result from these neuromuscular disorders can dominate the lont-term course and impede recovery.

In this observational study we try to measure muscle mass and body composition by echocardiography and BIVA at admission and on day 2, 5

Eligibility Criteria:
Inclusion Criteria:

* all acute admitted patients in ICU

Exclusion Criteria:

* age \< 18
* stay on ICU \< 48 hours
* use of corticosteroids
* neurological diseases
* acute kidney injure / nead of CVVH
Immersive Virtual Reality in Functional Motor Disorders

The study aims to demonstrate the effectiveness and superiority of a 5-day immersive VR-rehabilitation treatment versus a 5-day conventional rehabilitation treatment in reducing FMDs symptoms severity, assessed by the Simplified Functional Movement Disorders Rating Scale (S- FMDRS).

This is a single-blind, randomized controlled trial to evaluate the superiority of immersive VR distractors combined with graded physical exercises over conventional rehabilitation (without any VR distractors) to reduce FMDs symptoms and improve gait and balance. Patients will be randomized to receive the experimental training (VRG) or the control training (CRG) (allocation ratio 1:1). The primary and secondary outcomes will be measured by the same examiner before (T0), at the end of the treatment (T1), and at three-month follow-up after the end of the treatment (T2). The test order will be the same across all evaluation sessions. The examiner will be blinded to group assignments.

Eligibility Criteria:
Inclusion criteria were: established diagnosis of FMDs, age ≥ 18 years, and acceptance of the diagnosis.

Exclusion criteria were: prominent dissociative seizures, prominent cognitive and/or physical impairment that precluded signing the informed consent form for study participation based on clinical judgment, incomplete assessment, and questionnaire because of language comprehension difficulties.
Prevention of Neutropenia After Using G-CSF With TAC Chemotherapy

After resection of lymph node positive breast cancer, the injection duration and timing of Granulocyte-colony stimulating factor (G-CSF) could affect the neutropenia with TAC (Taxotere, Adriamycin, cyclophosphamide) chemotherapy.

The duration and the injection timing of G-CSF are effective in the prevention of neutropenia, incidence of infection and non hematologic toxicity. With the TAC chemotherapy after resection of breast cancer, the G-CSF early injection versus late injection could change the frequency of neutropenia.

Eligibility Criteria:
Inclusion Criteria:

* primary invasive breast carcinoma with lymph node positive with curative surgery with TAC chemotherapy

Exclusion Criteria:

* pregnancy,
* cardiovascualr disease,
* abnormal renal function,
* hematologic disorder
Treatment of Coronary De-novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter

To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon

To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon. Prospective, multicenter, randomized, single-blind, 70 patients. Experimental intervention: Predilatation of coronary de-novo stenosis followed by a sirolimus coated SeQuent®SCB balloon (sirolimus 4.0 μg/mm²). Control intervention: Predilatation of coronary de-novo stenosis followed by a SeQuent®Please or SeQuent®Please Neo balloon (paclitaxel 3.0 μg/mm²). Follow-up per patient: 30 days telephone call; 6 months angiographic + 12 months. clinical follow up

Key inclusion criteria: \> 18 years of age, Clinical evidence of stable or unstable angina or a positive functional study, Patients with significant coronary de-novo stenosis (≥ 70% diameter stenosis or intermediate ≥ 50% to \<70% diameter stenosis with positive functional test or symptom of ischemia), Successful lesion preparation (no flow-limiting dissection or a residual stenosis \> 30%).

Key exclusion criteria: Acute myocardial infarction within the past 72 hours (STEMI or NSTEMI), Intolerance and / or allergy to Sirolimus, Intolerance or allergy to Paclitaxel and/or the delivery matrix (main ingredient: iopromide), Patients with an ejection fraction of \< 30 %, Reference vessel diameter (RVD) \< 2.5 mm, Contraindication for whichever necessary accompanying medication.

Primary efficacy endpoint: late lumen loss in-segment at 6 months. Key secondary endpoints: Procedural Success: \< 30% final diameter stenosis, no flow-limiting dissection (type C or higher), TIMI III flow, and the absence of in-hospital MACE. MACE: cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization in-hospital at 6 and at 12 months Individual clinical endpoints at 6 and at 12 months: cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, (stenosis ≥ 50% at follow-up angiography)

Eligibility Criteria:
Inclusion Criteria:

* Clinical evidence of stable or unstable angina or a positive functional study
* Patients with significant coronary de-novo stenosis (≥ 70% diameter stenosis or intermediate ≥ 50% to \<70% diameter stenosis with positive functional test or symptom of ischemia)
* Successful lesion preparation (no flow-limiting dissection or a residual stenosis \> 30%)

Exclusion Criteria:

* Acute myocardial infarction within the past 72 hours (STEMI or NSTEMI)
* Intolerance and / or allergy to Sirolimus
* Intolerance or allergy to Paclitaxel and/or the delivery matrix (main ingredient:

iopromide)

* Patients with an ejection fraction of \< 30 %
* Reference vessel diameter (RVD) \< 2.5 mm
* Contraindication for whichever necessary accompanying medication
Clinical Profiles And In Vitro Fertilization Success

This research was carried out to determine if the IVF patients' clinical profile were connected with how successful in their getting pregnant. This was a cross-sectional study which recruited all patients, performed at a major fertility clinic in Indonesia. Our data collection period spanned between January 2017 and December 2021.

This study was conducted to determine whether there is an association between the clinical profile of in vitro fertilization patients and the success of pregnancy after in vitro fertilization in infertility patients.

The research was a cross sectional study using total sampling method, conducted on 223 infertility patients who performed in vitro fertilization at a tertiary fertility center in Bandung, Indonesia within the period January 2017-December 2021. Secondary data using medical records was taken.

We aimed to identify associations between the patient's age, the male partner's age, infertility duration, IVF protocol, fresh/frozen embryo, various infertility etiologies and the pregnancy rate in IVF programs. A p-value \<0.05 is considered significant.

Eligibility Criteria:
Inclusion Criteria:

* medical record data for in vitro fertilization patients at our facility from January 1,2017 to December 31, 2021

Exclusion Criteria:

* incomplete patient medical record data.
HighLife™ Transcatheter Mitral Valve Replacement System Study

Multicenter feasibility study of the HighLife™ TMVR system.

This is an exploratory clinical study designed to evaluate the feasibility, safety and performance of the Highlife TMVR System in a population of patients with severe symptomatic mitral regurgitation, who are not suitable for surgical or approved percutaneous treatments according to the judgement of the Heart Team. The data gathered in this study will allow to evaluate the feasibility of mitral replacement using the HighLife™ TMVR system and characterize the safety and performance profile of the HighLife™ TMVR System.

All patients will be followed periodically up to 12 months after the intervention and long term safety and performance will be collected annually up to 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Severe mitral regurgitation
* New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.
* Patient is under maximally tolerated GDMT (incl. CRT) for at least 3 months
* Multidisciplinary Heart Team consensus that the patient is inoperable or at high-risk for surgical repair/replacement due to significant co-morbid conditions
* Multidisciplinary Heart Team consensus that the patient is not a suitable candidate for other approved percutaneous repair therapy due to anatomical or medical conditions
* Patient meets the anatomical criteria for HighLife valve sizing as determined by CT and TEE

Main Exclusion Criteria:

* Mitral stenosis
* Rheumatic valve disease
* Severe calcifications of the mitral annulus and/or mitral leaflets
* Prior surgical or interventional treatment of the mitral valve
* Unsuitable anatomy for the transapical access
* Unsuitable anatomy of the aorta and ilio-femoral vessels for the transfemoral access
* Untreated clinically significant coronary artery disease requiring revascularization
* LVEF \< 30%
* LVEDD \> 70mm
* Echocardiographic evidence of intracardiac mass, thrombus or vegetation
* Hypertrophic Obstructive Cardiomyopathy (HOCM)
* Any surgical or interventional procedure (including PCI) done in the past 30 days prior to procedure
Preoperative Ultrasound as a Predictor for Difficulty in Bariatric Surgery

the left lobe of the liver in obese patient usually fatty and enlarged and may cause difficulty during bariatric surgery. the aim of this study is to test the impact of routine preoperative ultrasound to evaluate the size of left lobe of the liver as a preoperative predictor for difficulty

the left lobe of the liver in obese patient usually fatty and enlarged and may cause difficulty during bariatric surgery. the aim of this study is to test the impact of routine preoperative ultrasound to evaluate the size of left lobe of the liver as a preoperative predictor for difficulty. two equal groups of patients are operated by laparoscopic sleeve gastrectomy with loop bipartition, in one group routine abdominal ultrasound is done, in the other group ultrasound not routinely done.

Eligibility Criteria:
Inclusion Criteria:

* Morbidly obese patient with BMI more than 40 with or without co-morbidity
* Morbidly obese patient with BMI more than 35 with co-morbidity

Exclusion Criteria:

* Unfit patients for laparoscopy
* patients refuse to share in the study
* revisional surgery for obesity
* previous upper abdominal surgery
Prognostic Value of Circulating Tumoral Free DNA Versus Circulating Tumoral Cells in Patients With Colorectal Cancer Stage II-III

After curative surgical resection, detection of metastatic lymph node remains the main prognostic validated criteria on which is based the decision of adjuvant therapy. To date, none of the molecular alterations, identified as potentially predictive factor, are used in routine for therapeutic decision. The circulating markers, either in the form of free circulating DNA or in the form of circulating tumoral cells seems important potential candidates. To investigators knowledge, only one study estimated with several interesting results the prognostic interest of a coupled detection of the free circulating mutant DNA (gene KRAS) and by the hypermethylation of the p16 gene. Definitive conclusions remain however difficult to achieve because of the small number of patient included (n=58) and the fact that this study included different stages. For colorectal cancer a Chinese team presented a series of results suggesting that the presence of CTC during the postoperative course is a factor significantly related to the risk of recurrence. In multivariate analysis integrating the lymph node status and the vascular invasion, the presence of CTC appeared as an independent factor for recurrence with a hazard ratio of 29.5.

The aim of the present study is to compare the prognostic value of two circulating tumoral markers KRAS point mutations and RASSF2A methylation (free tumoral DNA) and Circulating tumoral cells (CTC). The primary objective is to compare sensibility and specificity of two circulating markers (free tumoral DNA and tumoral cells) on 2 years disease free survival rate. Secondary objective is to confirm the prognostic value of circulating free tumoral DNA and circulating tumoral cells in localised colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age superior to 18 years.
* Histologically confirmed colonic or rectal adenocarcinoma.
* stage II or III (TNM classification).
* Curative resection (R0)
* Absence of metastasis (abdominal ultrasonography or CTscan and pulmonary Rx or CTscan) in exams performed within 4 weeks.
* ECOG performance status \<3.
* Signed and dated informed consent document.

Exclusion Criteria:

* Metastatic disease.
* Familial adenomatous polyposis
* Prior chemotherapy and or radiotherapy within 6 weeks
* Medical history of cancer within 5 years except: basocellular cutaneous neoplasia and intraepithelial neoplasia of the cervix
A Study About Modified RNA Vaccines Against Influenza in Healthy Adults

The purpose of this study is to learn if modified RNA (modRNA) vaccines for the prevention of influenza are:

* safe; and
* how these vaccines produce an immune response in generally healthy adults. Immune response is the way the body protects itself against things it sees as harmful or foreign.

RNA (also called ribonucleic acid) is one of two types of nucleic acid made by cells. RNA contains information that has been copied from DNA (the other type of nucleic acid). Cells make several different forms of RNA, and each form has a specific job in the cell. Many forms of RNA have functions related to making proteins. RNA is also the genetic material of some viruses instead of DNA. RNA can be made in the laboratory and used in research studies. Also called ribonucleic acid.

Influenza is term used for flu illness. It is an infection caused by a virus that affects your mouth, nose, and throat.

The study is seeking for participants who:

* are at least 18 years of age
* have not received an influenza vaccine within the last 6 months
* are generally healthy

This study will be divided into three sub-studies: Substudy A (SSA), Substudy B (SSB), and Substudy C (SSC).

All participants, regardless of sub-study, will receive 1 dose of either of the following vaccines as an injection into their arm:

* 1 of the modRNA influenza vaccines that is being studied; or
* an approved influenza vaccine approved for use in their respective age group.

Participants will be involved in this study for about 6 months. During this time, participants will have at least 3 clinic visits.


Eligibility Criteria:
Key Inclusion Criteria

Applies to all 3 substudies:

* participants ≥18 years of age.
* generally healthy participants.

Substudy C ONLY:

- receipt of licensed influenza vaccination for the 2023-2024 flu season at least 6 months ago.

Key Exclusion Criteria

All 3 substudies:

* diagnosis of influenza (by clinical testing) in the last 6 months.
* immunocompromised individuals with known or suspected immunodeficiency
* receipt of any investigational or licensed influenza vaccines within 6 months.
ROX Index and ROX Vector to Predict Nasal High Flow / Continuous Positive Airway Pressure Failure in Neonates

Nasal continuous positive airway pressure (CPAP) and Nasal High Flow (NHF) therapy are two primary therapies for the treatment of respiratory distress in newborns. However, a considerable number of infants, who are initially treated with CPAP and NHF, will develop worsening respiratory failure and eventually require intubation for mechanical ventilation and the administration of surfactant. Infants who fail noninvasive respiratory therapy may suffer the consequences of delayed intubation, surfactant administration and other adverse outcomes. The most challenging decisions in the management of respiratory distress after birth is to decide when to move from a noninvasive respiratory support to invasive mechanical ventilation and give surfactant to decrease pulmonary damage and improve outcomes. There are no clinically adequate predictors of early CPAP failure at the time of admission to the neonatal intensive care unit. Many measurements have been investigated for their ability to predict CPAP failure in infants such as fraction of inspired oxygen (FiO2), partial pressure of oxygen (PaO2), PaO2/FiO2 and the stable micro bubble test as soon as possible after birth. Roca and colleagues first established the ROX index to predict the success of NHF therapy in adults with pneumonia. The ROX index combines three common measurements: FiO2, peripheral oxygen saturation (SpO2) and respiratory rate. Combining the ROX values with the change in the respiratory rate and FiO2 can indicate whether escalation is required. It was proposed that XY plot of the key components of ROX may show the direction of changes in vector form.

The investigators hypothesized that the ROX index and ROX vector can be used for predicting the failure of CPAP and NHF in neonates.

The objective is to explore the usefulness of ROX index to predict treatment failure of NHF and CPAP therapies in neonates.

The primary outcome is treatment failure within 72 h after start of the therapy with NHF or CPAP

Treatment failure criteria is reached once an infant is receiving maximal therapy for their treatment (NHF 8 L/min) or CPAP 7 cm H2O plus at least one of:

1. Sustained increase in oxygen requirement ≥50% to maintain peripheral oxygen saturation (SpO2) 90%-94%.
2. Any infant requiring urgent intubation and the subsequent mechanical ventilation, as determined by the physician.

Eligibility Criteria:
Inclusion criteria:

* They are admitted to a NICU when \<24 h old, AND
* The decision has been made by the attending clinician, to commence or continue (from stabilization at birth) non-invasive respiratory support (this does not include the provision of supplemental oxygen alone), AND
* They have not previously been intubated or received surfactant

Exclusion criteria:

* They immediately require intubation and ventilation (determined by attending clinician), OR
* They already satisfy 'treatment failure' criteria, OR
* They have a known major congenital anomaly or air leak
a 10-year Follow-up Study of a Randomized Clinical Trial

In this study, the investigators propose a 10-year follow up study of participants in a randomized clinical trial to compare the oral health-related quality of life (OHRQoL), as well as general and related satisfaction of conventional complete dentures fabricated using two different procedures.

Study design A 10-year follow-up study of a randomized controlled clinical trial (RCT) carried out from 2001 to 2003, including assessment of patient satisfaction, denture repair/replacement and OHRQoL. Data will be gathered through telephone interviews. Since the contacts were last used a decade ago, the phone number may have been changed, but we will make every effort to find new numbers for any participant those contact information is no longer valid .

Subjects Patients who participated and completed 6-month follow-ups in the RCT (T group: 50, and S group: 54; total 104 subjects) will be contacted by telephone.

Interviews and blinding Potential subjects will be told that we are investigating conditions of their dentures 10-years after the delivery and that we will ask general questions, as well as for their ratings of satisfaction and OHRQoL regarding their dentures. After this, the subjects will be asked whether they are willing to respond to the interviews. If they agree, the interviewer will ask the questions according to a flow chart (Appendix 1a, b). The subjects will not be told to which group they had been assigned, and a blinded research assistant will carry out the interviews and data gathering. The research assistant worked with these participants during the active study 10 years before. Patients will be excluded if they cannot respond properly to the questions.

Questionnaires Data will be gathered by four questionnaires: socio-demographic (Q1: Appendix 2), denture history/oral health (Q2: Appendix 3), general and related satisfaction outcomes by answering VAS (visual analog scale) scores out of 100 (Q3: Appendix 4), and OHQOL measures (OHIP-EDENT) 12, 13 (Q4: Appendix 5).

Analysis Denture history The difference in number of people who keep and use the dentures at 10 years will be calculated in percentages. A Chi-squared test will be employed for the statistical analyses. Finally, the prevalence of problems associated with the dentures will be calculated.

Satisfaction The differences between the treatment groups in their general satisfaction ratings on 100mm VAS after the prostheses are worn for 10 years. A two-sample independent t-test will be employed. VAS items of comfort, stability, esthetics, retention, function and ease of cleaning are also included. These will be compared between the groups using t-tests.

OHRQoL OHIP-EDENT consists of 19 statements and responses varying from 0 to 4 on a Likert scale. The possible range between 0 and 76 will be derived individually and compared between the two groups. A two-sample independent t-test will be employed.

Eligibility Criteria:
Inclusion Criteria:

* Who can be contact with telephone call and accept the interview

Exclusion Criteria:

* The line is closed, no response, who have deceased.
* Refused to answer