cyrilzakka/clinical-trials huggingface dataset:
Treatment of Atraumatic Rotator Cuff Rupture in Elderly Patients

The purpose of the investigators study is to compare the effect of: 1) physiotherapy 2) arthroscopic acromioplasty and debridement or 3) arthroscopic rotator cuff reconstruction and acromioplasty in the treatment of degenerative, atraumatic rotator cuff rupture.

The study will be conducted according to the revised Declaration of Helsinki by The World Medical Association and the ICH-guidelines for good clinical trial practice. The study will be submitted for approval to the Ethics Committee of the Hospital District of Varsinais-Suomi, Finland. A written informed consent will be obtained from each patient.

This study will be conducted at three different hospitals i.e. Turku University Hospital, Tampere University Hospital (Hatanpää hospital) and Kuopio University Hospital as a multicenter study. A total of 180 patients, 60 patients at each hospital, will be included in this study. The patients are clinically examined and a routine x-ray and MRI-investigation are performed. Patients must have an atraumatic degenerative supraspinatus tendon rupture comprising less than 2/3 of the tendon insertion, i.e. 1/3 of the tendon insertion must be intact. The rupture must be documented by MRI investigation. Patients must be willing and give a written informed consent. After recruitment the patients are randomized in one of three studied treatment modalities. The randomization is made after clinical and MRI investigation by neutral attendant using sealed envelopes. 60 identical envelopes (20 per group) are made in each center.

The Constant score is used as a primary outcome measure. The Constant score is measured from each patient right before treatment intervention and at three and six months, one, two and five years after the intervention. The intervention groups are designed in a cumulative fashion: structured and standardized physiotherapy treatment proceeds gradually in all patients (groups 1,2,3), in addition to physiotherapy patients in group 2 are treated with acromioplasty, and patients in group 3 with acromioplasty and rotator cuff reconstruction.

Eligibility Criteria:
Inclusion Criteria:

1. age over 55 years
2. atraumatic penetrating supraspinatus tendon rupture comprising less than 2/3 of the tendon insertion and documented with MRI investigation.
3. full active range of motion
4. written informed consent from participating subject

Exclusion Criteria:

1. age under 55 years
2. existing significant malignant, haematological, endocrine, metabolic, rheumatoid or gastrointestinal disease
3. cytostatic or corticosteroid medication
4. glenohumeral osteoarthrosis grade III or above (X-ray evaluation with present osteophytes according to Kellgren-Lawrence classification)
5. history of alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent
6. previous same shoulder surgery
7. a massive tendon tear involving the whole supraspinatus tendon and/or combined tear of two - three tendons ie. supraspinatus with infraspinatus or subscapularis tendon tear.
8. patients denial
Assessment of Organ Failure Risk Predictions in ICU

During this observational study, the investigators aim to assess the ability of ICU clinicians to predict the risk of impending organ failure and retrospectively compare it to the performance of previously published machine learning models. The central hypothesis of this study is that the treating physician can predict impending organ failure in adult ICU patients with similar accuracy as the best previously publishes machine learning models.

In this observational study, clinician's (physicians and nurses) assessment of the estimated imminent organ failure risk in an ICU setting are prospectively collected. Circulatory failure is investigated in the primary objective, and respiratory failure, renal failure, and mortality are investigated in secondary objectives. These assessments investigate the predictive performance and influencing factors for clinician prediction. The assessments will be collected in questionnaires and be performed by the clinicians directly involved in the patient treatment and by clinicians who are not actively responsible for the patient treatment. Furthermore, this study aims to benchmark these risk assessments made by healthcare professionals against retrospectively generated AI risk scores for the same patients and timepoints. The AI risk scores will be calculated retrospectively from a set of models from a systematic search of the current literature. The AI models that will be employed for this analysis will be identified as indicated by a systematic review protocol and must satisfy the following two criteria: they do not require any data beyond what is routinely collected during an ICU stay and may be accessed as open source. Such a comparison is vital for the understanding of the relative accuracy and reliability of AI-based predictions in the context of organ failure risk compared to human performance. The data and findings from this study are anticipated to provide evidence for the clinical utility of AI-based risk scores and pave the way for future research into the optimization of AI systems for healthcare applications.

Eligibility Criteria:
Inclusion Criteria:

* patient minimum age of 18 years
* emergency admission to the ICU
* arterial line in place

Exclusion Criteria:

* documented refusal (on the general consent form) to participate to clinical research
* patients with neurologic conditions that impair the patient's level of consciousness (including, but not limited to stroke, traumatic brain injury, intracranial hemorrhage, CNS infections; except polytrauma)
* patients on mechanical circulatory support systems (IABP, VA-ECMO, Impella, VAD) or extracorporeal membrane oxygenation (VV-ECMO) at any time during their ICU stay;
* patients receiving end-of-life care or are admitted for the sole purpose of evaluating organ donation
Utility of a Supraaponeurotic Mesh as Prophylaxis of the Midline Eventration After an Oncological Colorrectal Resection

Randomized prospective experimental study, in which the effect of a prophylactic mesh is assessed in the eventration rate diagnosed by CT at one year after surgery in patients with CRC who underwent elective intervention for supra-infraumbilical midline laparotomy, considering as treatment the supra-aponeurotic mesh positioning (experimental group), and comparing it to the standard closing with a continuous suture using slow absorption monofilament.

Randomized prospective experimental study, in which we evaluate patients with CRC who underwent elective intervention for supra-infraumbilical midline laparotomy in order to:

Main objective:

- To assess the effect of the prophylactic mesh in the eventration rate diagnosed by CT at one year after surgery in patients with CRC who underwent elective intervention for supra-infraumbilical midline laparotomy.

Secondary objectives:

* To compare the appearance of complications in the control group and in the experimental group.
* Compare costs derived from short and long-term mesh placement in both groups.

We consider as treatment the supra-aponeurotic mesh positioning (experimental group), and compare it to the standard closing with slow absorption monofilament.

Eligibility Criteria:
Inclusion Criteria:

* Elective surgery for colorectal cancer.
* Surgery by middle laparotomy.
* Informed consent signed by the patient.
* Age \> 18 years.

Exclusion Criteria:

* Midline hernia or eventration.
* Presence of mesh in the abdominal wall because of a previous surgery.
* Palliative surgery.
* Synchronous metastases (Stage IV cancer according to TNM).
Short Term Treatment With BI 201335, Peginterferon-alpha 2a and Ribavirin in Hepatitis c Virus Genotype-1 Treatment-naïve Patients (SILEN-C3)

To compare the antiviral efficacy and safety of a 12-week with a 24-week treatment of BI 201335 at a dose of 120 mg once daily, with a 24-week background of pegylated interferon-alpha 2a (PegIFN) plus ribavirin (RBV), in treatment-naïve patients infected with hepatitis C virus (HCV) genotype 1


Eligibility Criteria:
Inclusion criteria:

1. Chronic hepatitis C infection of genotype 1
2. Therapy-naïve to interferon, pegylated interferon, and ribavirin
3. HCV viral load \> 100.000 IU/ml at screening
4. Liver biopsy or fibroscan within two years prior to screening that provides evidence of any degree of fibrosis or cirrhosis
5. Normal retinal finding on fundoscopy within 6 months prior to Day 1
6. Age 18 to 70 years

Exclusion criteria:

1. HCV of mixed genotype (1/2, 1/3, and 1/4) .
2. Patients who have been previously treated with at least one dose of any protease inhibitor
3. Evidence of liver disease due to causes other than chronic HCV infection
4. Positive for HIV-1 or HIV-2 antibodies
5. Hepatitis B virus (HBV) infection
6. Decompensated liver disease, or history of decompensated liver disease
7. Active malignancy or history of malignancy within the last 5 years
8. History of alcohol or drug abuse (except cannabis) within the past 12 months.
9. Body Mass Index \< 18 or \> 35 kg/m2.
10. Usage of any investigational drugs within 30 days prior to enrolment
11. Alpha fetoprotein value \>100ng/mL at screening;
12. Total bilirubin \> 1.5 x ULN with ratio of direct/indirect \> 1.
13. ALT or AST level \> 10 x ULN
Effectiveness and Safety of Niraparib as First-line Maintenance Therapy for Ovarian Cancer: a Real-world Study

In order to explore the real situation of niraparib in clinical application more comprehensively and deeply, we conducted the first multicenter, real-world study in China. This large observational study used real-world data to assess the effectiveness and safety of niraparib as maintenance therapy in patients with advanced ovarian cancer (AOC) in China and investigated clinical factors associated with prolonged benefits of niraparib so as to achieve the maximum clinical benefit of patients.

This is a retrospective multicentric study including advanced ovarian cancer patients that have used niraparib as first-line maintenance therapy after chemotherapy from fourteen hospitals in China between January 2019 and December 2021. The database lock-time was on December 31, 2022. All data were retrieved from the patients' medical records. Clinical data, including patient demographics, clinicopathological characteristics, residual disease after primary surgery, genetic-testing results and so on, were collected. Missing information was supplemented by telephone follow-up or face-to-face inquiries (only for patients who were alive and accessible). The incidence of AEs, as well as dose reductions, dose interruption, and discontinuation of treatment due to AEs were recorded.All analyses were performed on the safety population. The categorical variables were described as a frequency and percentage, and the continuous variables were described as a median and range. No formal sample size calculation was performed since the study was exploratory. Survival analyses were conducted using the Kaplan-Meier method and log-rank test. 95% confidence intervals (CIs) were calculated using the Clopper-Pearson method. Univariate and multivariate Cox regression models were established to determine factors that could affect the PFS for patients receiving niraparib maintenance treatment. Missing data were assigned as unknown for the univariate and multivariate analysis. The method of cox analysis was stepwise regression, and the screening criterion was Akaike Information Criterion (AIC). A P-value of \<0.05 was considered statistically significant. Descriptive statistics (number and percentage) were used to summarize the safety data by treatment. Statistical analyses were performed using the R software version 4.2.2 (R Project for Statistical Computing).

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* diagnosed with histologically confirmed ovarian cancer (International Federation of Gynecology and Obstetrics \[FIGO\] Stage II-IV)
* underwent surgery and first-line chemotherapy and were treated with niraparib as maintenance therapy
* the date to start maintenance therapy with niraparib is from January 2019 to December 2021

Exclusion Criteria:

* had experienced other malignancies within the previous 5 years
* enrolled in clinical trials in which investigators were blinded to the treatments
* with a previous or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
Study of Osteogenesis Imperfecta Tendon

Osteogenesis imperfecta (OI) is a rare genetic disease due to a mutation in one of the genes encoding either type I collagen or a protein involved in its synthesis. This leads to bone fragility with fractures and deformities. However, other tissues rich in type I collagen can also be affected, such as teeth or vessel walls.

In the literature, several case reports describe tendon ruptures in OI patients, but no original study has really addressed this issue, which is likely to impact the quality of life through a reduction in mobility and pain.

Recent work carried out by the investigators shows an alteration of the osteotendinous unit in the osteogenesis imperfecta mouse (oim), a validated model of the most severe form of OI. Consequently, the project aims to study the damage of tendon and ligament in patients suffering from osteogenesis imperfecta.

This project aims to study the damage of tendon and ligament in a cohort of patients suffering from osteogenesis imperfecta. The data collected will be put into perspective with those of our first experimental work on mice. They will also make it possible to complete the specific care of these patients. Indeed, during the anamnesis, particular attention will be paid to the description of tendon-ligament pain in order to propose the most effective treatment for this kind of disorder, mainly in physiotherapy. Prevention work will surely be necessary with patients and caregivers.

Eligibility Criteria:
Inclusion Criteria:

* to have an osteogenesis imperfecta

Exclusion Criteria:

* none, since we want to study different types of osteogenesis imperfecta and consider the effect of age.
Disease and Biomarker Profiling of Chinese Lupus Nephritis

In the proposed study , Novartis Institutes of Biomedical Research ( NIBR ) collaborates with Reni HospitalAffiated to Shanghai Jiaotong University School of Medicine ( Ren ) , aiming to identify particular LNendotype , and to discover novel biomarkers which link the endotype to disease phenotype , especially todisease monitorng , treatment response and prognosis prediction . The study proposes to take bothcandidate approach ( reported biomarkers ) and unbiased high-throughput proteomics profiling tools( Somascan measures up to 7,000 protein analytes ) to analyze 100 Class I / V LN patients with welldocumented clinical annotation , treatment schedule and disease follow up . Both serum / plasma and urrpatients will be extensively characterized with a focus on non-invasive biomarkediscovery and validation . Integrated analysis will be performed to associate patient molecular signature withtheir clinical annotation , renal pathology features , and response to Soc treatment . We will generahypothesis from these analyses to propose molecular markers to predict patient response to Soc treatmentand to endotype the disease , discover the mechanisms that could contrbute to unsatisfactory response toSoc , and identity more specific and sensitive non-invasive biomarkers in serum or urine that can be used in disease monitoring , disease prognosis and patient stratificationproposed study Will help usunderstand the heterogeneity of LN at the molecular level , which could be an essential first step towardsLN precision medicine . It will provide scientific rationale for improved LN clinical diagnosis , novel therapeutichypothesis , patient stratification , clinical study design and combination strategy.


Eligibility Criteria:
Inclusion Criteria:

* 1. Able to communicate well with investigator, understand the study procedures and provide writteninformed consent before any study-related sample/data are accesse 2. Men and women with systemic lupus erythematosus (see below), aged 18 years and 75 years fulfilling 1997 ACR classification criteria for SLE, or 2012 SLICC classification criteria for SLE,OI2020 eularacr classification criteria for sstological diagnosis of proliferative lupusnephritis wealth OrganizationO)ISN/RPS (Weening et al 2004) Class I or class IV,with soc treatment anddisease monitoringleast one year 3. Serum/plasma and urine samples were collected at baseline of the treatme

Exclusion Criteria:

* 1.Presence of another autoimmune rheumatic disease that is active and constitutes the principalIllness , except for rheumatoid arthritis , Sjogrens syndrome and autoimmune thyroiditis 2 . Any glomerulonephritis other than WHO Class l or V lupus nephritis Patients with proliferativenephritis ( Class l or V ) who , in addition , have overlapping histological signs for other glomerulonephritis , e.g. , Class V are eligible at the investigator s discretion 3. History of malignancy with the exception of basal cell or squamous cell carcinoma of the skin orsitu carcinoma of the cervix within the last 2 vears 4 . Urinary system infection 5 . Pregnant women
Molecular Signatures of Relapse in Tissue Samples From Patients With Small Cell Lung Cancer Who Are Receiving Cisplatin and Etoposide

This pilot research trial studies molecular signatures of the return of cancer after a period of improvement (relapse) in tissue samples from patients with small cell lung cancer who are receiving or planning to receive cisplatin and etoposide. Studying samples of tissue from patients with small cell lung cancer in the laboratory may help doctors learn more about the changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer relapse.

PRIMARY OBJECTIVES:

I. To collect and analyze small cell lung cancer (SCLC) tumor DNA and ribonucleic acid (RNA) from 3 human patients before and after relapse to identify the molecular signatures of relapse.

OUTLINE:

Previously collected tissue samples are analyzed via RNA sequencing and DNA methylation at baseline. Patients also undergo collection of tissue samples for analysis at relapse.

Eligibility Criteria:
Inclusion Criteria:

* Any patient seen at Norris or County with histologically confirmed SCLC, with tissue in the Norris Cancer Center Tumor Repository
* Patients must be undergoing or about to start first line treatment with cisplatin and etoposide
* Patients may not have a second malignancy
Clinical Study for the Impact of Bio-absorbable Felt (NEOVEIL®) With Fibrin Sealant on Removal of Drainage Tube After Minimally Invasive Gastrectomy for Gastric Cancer

This study is to evaluate if Bio-absorbable Felt(NEOVEIL®) makes the amount of exudate reduce and shortens time until drain removal after minimally invasive surgery for early gastric cancer.

We investigate the effect on drainage amount of Bio-absorbable Felt(NEOVEIL®) after D1+b or D2 lymphadenectomy with distal gastrectomy for early gastric cancer.

This study is an randomised controlled trial undertaken in 7 centers in South Korea. Patients with stage I-II gastric cancer who is going to have curative distal gastrectomy with D1+b or D2 lymphadenectomy are randomly assigned to use bio-absorbable felt(NEOVEIL®) or not to use it. Block randomisation will be done by a central interactive computerised system, stratified by center.

Eligibility Criteria:
Inclusion Criteria:

* histologic confirmed gastric adenocarcinoma
* Patients who underwent laparoscopic distal gastrectomy.
* preoperative clinical stage I diagnosed with esophagogastroduodenoscopy,endoscopic ultrasonography and computerized tomography.
* patients who underwent more than D1+b lymphadenectomy

Exclusion Criteria:

* Vulnerable participants (pregnant women, under 20 year old, and so on)
* liver or renal disease (Ex. liver cirrhosis, end stage renal disease)
* Transfusion is needed preoperatively or postoperatively due to bleeding
* Preoperative or intraoperative evaluation confirm ascites.
* Patients who use anticoagulant preoperatively or postoperatively
Integration of NAVOY® Sepsis in an Electronic Health Record System

The study aims to evaluate the performance of NAVOY® Sepsis in predicting the sepsis risk in adult ICU patients. Data collection is performed via automatic retrieval from the electronic health record system to AlgoDx proprietary cloud service where it is analysed in a simulated environment.


Eligibility Criteria:
Inclusion Criteria:

* The subject is admitted to the ICU during the enrolment period.
* The subject is 18 years of age or older at the time of admission to the ICU.

Exclusion Criteria:

* None.
SmartGlass-Guided ERCP with Cannulation of Native Papilla 1.0

The aim of this prospective randomized study is to evaluate whether telemedical assistance via SmartGlasses is equivalent to physical presence in teaching Endoscopic Retrograde Cholangiopancreaticography (ERCP) in terms of examination success and safety. Endoscopic papilla cannulation is a key skill for successful ERCP and therefore a measurable primary endpoint of the study. This can be measured as the time (in seconds/minutes) between stable visualization of the papilla and successful endoscopic cannulation of the target structure (bile duct or pancreatic duct).

In sparsely populated regions of a country and where there is a lack of experienced specialists, it may not always be possible to have an experienced ERCP examiner present during an examination. Therefore, telemedical examination assistance via a connection to data glasses worn by the examiner is a possible option to replace the physical presence of an instructor or experienced ERCP examiner.

The aim of this prospective randomized study is to evaluate whether telemedical assistance via smart glasses is equivalent to physical presence in terms of examination success and safety. Endoscopic papilla cannulation is a key skill for successful ERCP and therefore a measurable primary endpoint of the study. This can be measured as the time (in seconds/minutes) between stable visualization of the papilla and successful endoscopic cannulation of the target structure (bile duct or pancreatic duct).

In addition to other efficacy endpoints, adverse events, which are expected to be rare, will be documented at 48-hour intervals and calculated as a rate. Telemedical 'live' support of an ERCP via data glasses has not yet been demonstrated or tested in a trial. To ensure the safety of the examination under these circumstances, the training examiner is present in the neighbouring room and can physically assist or take over the examination at any time if necessary.

Eligibility Criteria:
Inclusion criteria

* Adult patients aged ≥ 18 years without previous papillotomy Exclusion criteria
* Cannulation of the minor papilla necessary
* Significant comorbidity
* Haemodynamic instability
* Pregnant women
* Refusal or inability to give written informed consent for the study
* Instructor had to perform the examination himself/herself
Influence of an Exercise for Trunk Stabilization Performed in Stable and Unstable Surfaces for Chronic Low Back Pain.

Motor control exercises have demonstrated a good option for recovery from chronic low back pain. The purpose of this study is investigated the effectiveness of an exercise program for trunk stabilization performed in stable and unstable surfaces for people with nonspecific chronic low back pain (NCLBP). Patients will be randomly divided into 3 groups; control group will receive placebo treatment with shortwave; stable group will receive an exercise protocol to stabilize the trunk on a stable surface and unstable group will receive the same exercise protocol but performed on an unstable surface.

We hypothesized the unstable group will present pain reduction and functional improvement.


Eligibility Criteria:
Inclusion Criteria:

* Non-specific low back pain
* Sedentary
* Previous low back pain last 6 months

Exclusion Criteria:

* Traumatic, inflammatory, infectious or tumours etiology
* Positive neurological findings (leg pain)
* Pregnancy
* Previous spine or lower limb surgery
* Contraindicated for short-waves aplication