cyrilzakka/clinical-trials huggingface dataset:
Advanced Therapy Registry of IBD Patients

The study is aim to detect common microbial profiles and metabolic pathways throughout IBD diagnosis and treatment with biological therapy.

The study is aim to detect common microbial profiles and metabolic pathways in patients belonging to the following groups:

1. Therapy naïve newly diagnosed Crohn's disease (CD), ulcerative colitis (UC) and pouchitis patients. Studying this group of patients will enable the detection of microbial profiles associated with disease onset.
2. Patients planned to commence biological therapy (with or without IBD). Studying this group of patients will enable the detection of microbial profiles associated with response to biological therapy.
3. IBD patients in complete remission (treated or untreated with biologics). Following this group of patients will enable the detection of microbial profiles associated with disease exacerbation.

Methods:

Study design: A prospective cohort study. Setting: The investigators will prospectively collect clinical, behavioral and environmental data of patients participating in the study. Data will be collected according to a uniform standardized protocol specifically adapted to the needs of the study and shared between the collaborators.

Study population: Eligible patients, who sign an informed consent form and answer to all the study inclusion criteria. Patients will be informed of the study by their treating physician, recruited and followed throughout the follow-up period by study coordinators.

sample size: sample size was estimated according to clinical capabilities of the researcher. We aim to collect data from a total of 1000 patients.

Schedule: Data will be collected between the years 2019-2024.

Study plan:

Patient and disease characteristics At baseline, demographic characteristics, medical history and specifically IBD phenotype, severity, extent and location, disease duration, previous medicinal treatment will be documented. Baseline and follow-up study visits which will include biological sample collection and questionnaires.

Patients will be asked to complete questionnaires to account for their lifestyle, sleep, quality of life and disease related symptoms and outcomes. Physician global assessment (PGA), disease severity using clinical scores (HBI and SCCAI scores for CD and UC patients) and biochemical data (CRP, fecal calprotectin) will be documented.

Eligibility Criteria:
Inclusion Criteria:

Patients who belong to one of the following sub-groups:

1. Newly diagnosed (\<1 years), therapy naïve IBD and pouchitis patients
2. IBD patients in complete remission (treated or untreated with biologics)
3. Patients (with and without IBD) scheduled to commence a biological therapy

Exclusion Criteria:

1. Age≤18 years
2. Inability to sign an informed consent
3. Abdominal surgery during the previous 3 months
4. Systemic antibiotic therapy in the previous 4 weeks
5. Severe systemic disease such as kidney, liver, neurologic, cardio-vascular disease
6. Primary sclerosing cholangitis
7. Pregnancy at recruitment
8. Cancer within the previous 5 years excluding local NMSC
Effect of Person-Centred-Care on Antipsychotic Drug Use in Nursing Homes: a Cluster-randomised Trial

Background: Up to 90% of nursing home residents with dementia experience behavioural and psychological symptoms like apathy, agitation, and anxiety. According to analyses of prescription prevalence in Germany, antipsychotic drugs seem to be prescribed as first line treatment of neuropsychiatric symptoms in persons with dementia. A huge number is prescribed for inappropriate reasons and too long without regular review. The use of antipsychotics is associated with adverse events like increased risk of falling, stroke, and mortality. This study aims to investigate whether a person-centered care approach developed in the United Kingdom can be adapted and implemented in German nursing homes. The aim of the investigators trial is to achieve a clinically relevant reduction of the proportion of residents with alt least one antipsychotic drug prescription.

Methods/Design: Cluster-randomised controlled trial comparing an intervention group (two-day initial skill training on person-centred care and on-going training and support programme) with a control group receiving optimised usual care. Both study groups will receive a medication review by an experienced psychiatrist with feedback to the prescribing physician. Overall, 36 nursing homes from East, North and West Germany will be included and randomised. The primary outcome is defined as the proportion of residents receiving at least one antipsychotic medication at 12 months. Secondary outcomes are residents' quality of life, behavioural and psychological symptoms of dementia as well as safety parameters like falls and fall-related medical attention. Cost parameters will be collected and process evaluation will be performed alongside the trial.


Eligibility Criteria:
On cluster level

Inclusion Criteria:

* nursing homes with at least 50 residents

Exclusion Criteria:

* other ongoing trial in the institution

On individual level

Inclusion Criteria:

* all residents within a cluster are eligible to participate in the study

Exclusion Criteria:

* diagnoses of schizophrenia, schizoaffective psychosis, or other forms of primary psychosis
* respite care
Restricted Intravenous Fluid Regime Effects on Immunological Indicators of Elderly Patients Operated for Abdominal Cancer

The purpose of this study is to find out whether perioperative fluid restriction influence on postoperative immunological function. And discuss the probable mechanism that fluid restriction regime effect on clinical data.

Perioperative fluid administration is a common therapy in clinical practice, and recent regime has a history about 50 years. Recently, clinicians found that traditional regime had some disadvantages, for example, pulmonary edema, increased cardiac load, increased body weight. And thus, perioperative fluid restriction regimen has been suggested and proved could reduce cardiopulmonary complications and mortality rates after major elective gastrointestinal surgery.

Patients were divided into two groups randomly and underwent restricted fluid regimen or traditional fluid regimen. We determined the complications and immunological function in two groups, and analyzed the relationship between complications and immunological changes. Based on this we decide the probable mechanism that perioperative fluid restriction effects on complications.

Eligibility Criteria:
Inclusion Criteria:

* All patients(age≧65y) who was admitted for gastrointestinal cancer surgery were considered eligible if they had no life-threatening systemic disease (ASA groups 1\~3)

Exclusion Criteria:

* lactation
* mental disorders
* language problems
* smoking within two weeks
* diabetes mellitus
* renal insufficiency
* disseminated cancer
* secondary cancers
* inflammatory bowel disease, or diseases hindering epidural analgesia
A Clinical Trial to Evaluate the Pharmacokinetics and Safety/Tolerability of Fimasartan and Atorvastatin in Healthy Male Volunteers.

The purpose of this study is to evaluate the Pharmacokinetics and Safety / Tolerability of Fimasartan and Atorvastatin in Healthy Male volunteers.

This is a randomized, open-label, single dose, 3x3 partial replicated crossover study to evaluate the pharmacokinetics and safety/tolerability. Within each period, randomized subjects will be 2 dosing regimens with a fixed dose combination of Fimasartan/Atorvastatin and co-administration of Fimasartan and Atorvastatin.

Eligibility Criteria:
Inclusion Criteria:

* A Healthy male aged 19-50 years
* Body weight is over 55kg and BMI 18 \~ 27(kg/m2).
* A subject provide written informed consent which he voluntarily confirms willingness to participate in a study, having been informed of the full details of the study and comply with the protocol.
* A subject who is eligible according to investigator's assessment

Exclusion Criteria:

* History or presence of clinically significant medical or psychiatric condition or disease.
* History of gastrointestinal disease and resection
* Hypersensitivity to ingredient of investigational product(IP) and other medication, food.
* Genetic Problem such as Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption.
* A subject who take a drug that inhibit or induce significantly Drug-Metabolizing Enzyme within 1months.
* Positive results for serum examination(HIV, B and C viral test, Syphilis).
* Seated BP is less than 100/65 mmHg or greater than 140/90 mmHg at screening.
* Participation in any other study within 3months.
* History of whole blood donation within 2months and Apheresis 2 weeks.
DNA Methylation Dynamics Underlying Arterial Remodeling in PAH Patients: CLEOPAHTRA Clinical Trial

To identify epigenetic-sensitive modifications and novel biomarkers linked to pathogenesis of pulmonary arterial hypertension (PAH), we will perform the first study analyzing differentially-methylated regions (DMRs) in circulating T cells (CD04+ and CD08+) isolated from peripheral blood of patients undergoing right heart catheterization. Moreover, we will perform RNA deep sequencing on lung tissue biopsies to validate if DNA methylation signatures in circulating T cells could reflect perturbations of gene expression in lung tissues.

Pulmonary arterial hypertension (PAH) is characterized by remodeling of pulmonary arteries caused by an inbalance of proliferation/apoptosis rate within the vascular wall. This pathological phenotype seems to be triggered by different environmental stress and injury events such as increased inflammation, DNA damage, and epigenetic deregulation. Many immune cells are increased in PAH, such as T and B lymphocytes. Remarkably, T cells are essential players of adaptive immunity and may be relevant initiators ("initial hit") of vascular remodelling. We will perform the first multi-omics study to: 1) investigate DNA methylome of circulating T cells isolated from peripheral blood of PAH patients, 2) detect transcriptomic profiles of lung tissues, 3) to assess if DNA methylation of distinct genomic regions in circulating T cells could reflect modifications of lung gene expression programs.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed patients with World Health Organization (WHO) Group I PAH.
* ≥ 18 years
* Documentation of the following hemodynamic parameters by right heart catheterization, performed at time of study enrolment:
* Mean pulmonary arterial pressure (mPAP) \> 25 mmHg at rest or mPAP \> 30 mm Hg with exercise.
* Pulmonary arterial wedge pressure (PAWP) ≤ 15 mm Hg.
* Pulmonary vascular resistance (PVR) ≥ 240 dynes.sec.cm-5 (e.g., ≥ 3.0 Wood units)

Exclusion Criteria:

* Patients who meet the criteria for inclusion into WHO Groups II, III, IV or V.
* Do not meet the required hemodynamic criteria for entry into the study.
* Patients with known history of cancer, malignancy disorders, active infections, and chronic or immune-mediated diseases.
Therapeutic Effect of Crizotinib for Rearrangement-negative, High Phosphorylated ALK Patients

Patients with histologically or cytologically confirmed stage IIIB or IV ALK-negative non-small-cell lung cancer (NSCLC) participated in this study following the failure of initial treatments. The ALK phosphorylation expression was detected in histologic samples of patients. patients with positive ALK phosphorylation expression were treated with crizotinib .

Some patients with histologically or cytologically confirmed stage IIIB or IV ALK-negative non-small-cell lung cancer (NSCLC) participated in this study following the failure of initial treatments. The ALK phosphorylation expression was detected in histologic samples of patients. patients with positive ALK phosphorylation expression were treated with crizotinib 250 mg/day orally. A treatment cycle was defined as 30 days of once-daily crizotinib treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 years and 80 years
2. Histologically or cytologically confirmed stage IIIB or IV ALK-negative NSCLC by NGS
3. Disease staging determined according to the International Association for the Study of Lung Cancer 8th edition TNM staging system
4. All measurable Response Evaluation Criteria in Solid Tumors (RECIST) target lesions
5. Treatment failure at the end of the most recent treatment episode
6. World Health Organization/Eastern Cooperative Oncology Group (ECOG) performance status 0-2
7. Consent of patients for participation in this study
8. Complete clinical data
9. High ALK phosphorylation level

Exclusion Criteria:

1. Patients with cognitive impairment, severe psychiatric diseases, or other disorders likely to impact informed consent
2. Patients with uncontrolled systemic disease
3. Patients with other malignant tumors
Micro-dosing Indocyanine Green (ICG) in Children

The goal of this cohort study is to identify the lowest dose of Indocyanine Green (ICG) that achieves satisfactory intra-operative fluorescence for the assessment of gastrointestinal or genitourinary tract perfusion in children.

Indocyanine Green (ICG) fluorescence-guided surgery (FGS) can be used to assess gastrointestinal and genitourinary tract perfusion intra-operatively. In adults, the use of ICG has been shown to improve surgical outcomes. ICG is safely used intra-operatively in children, but there is a lack of evidence regarding the lowest clinically useful dose of ICG.

This is a single centre open-label dose escalation study that aims to:

1. identify the minimal clinically useful dose of ICG for intra-operative perfusion assessment in children (0 - 18 years old)
2. assess the safety profile of intra-operative ICG in children
3. characterise the intra-operative fluorescence of ICG in children

Eligibility Criteria:
Inclusion Criteria:

* Children aged ≤18 years of age
* Elective surgery including gastrointestinal or genitourinary tract perfusion assessment

Exclusion Criteria:

* Renal and liver dysfunction
* Active infection
* Coagulopathy
* Complex congenital heart defect
* Previous documented allergy to ICG injection or other iodinated contrast agents
* Patients suffering from hyperthyroidism or autonomic thyroid adenomas
* Premature infants or neonates in whom exchange transfusion is indicated, due to the hyperbilirubinaemia risk
* Concurrent use of sodium bisulphite-containing preparations, such as certain heparin preparations
Predictive Factors of a Successful Implant of the CapsureFix MRI Model 5086

Pacing leads are key elements of a pacing system as their proper functioning is one of the major factors affecting the long term performance of the whole system.

Success of a pacing lead implant can be defined considering 3 items: ease of lead implant, lead stability and lead electrical performances.

These factors may be related to the physician experience (global implant experience, experience with a given lead), to the implant procedure (lead access, lead position, implant time, scopy time) to the lead (handling and mechanical characteristics) and to the patient (ischemic history).

Even though implant success rate is quite high with currently available leads, the weight of the different factors influencing success has never been studied systematically. The objective of the current study is then to define the predictive factors of an implant success with the CapsureFix MRI model 5086.

This lead has been selected because it has been available for a short period, so the investigators have a limited experience of it and it has a unique design which makes it conditionally safe in an MRI environment and which may be associated with specific handling characteristics.


Eligibility Criteria:
Inclusion Criteria:

* Patient older than 18
* Patient implanted with a fully automatic ICD and remotely followed-up,
* Patient geographically stable and able to attend FU at investigative site
* Patient who signed a data release authorization form,

Exclusion Criteria:

* Patient whose mental or physical capacity impedes to give an informed data release authorization,
* Patient already enrolled in a clinical study whose procedures may interfere with the results of the present study,
* Patients in New York Heart Association (NYHA) class IV
Can a Simple Trephination Increase the Heeling Potential for All-inside Meniscal Repair in the Vascular Zone?

Meniscus does not always heal when sutured. The investigators will make small holes in the meniscus before repair to promote more bleeding. The investigators expect that will help the meniscus to heal better.

RCT study to evaluate the effect on trephination together with meniscal repair on meniscus healing after repair.

Eligibility Criteria:
Inclusion Criteria:

* Adults who have a meniscus repaired.

Exclusion Criteria:

* Meniscus not fit for repair.
* Patients not fit for the repair regime.
* Arthrosis \> stadie 2 (ICRS).
* Prior attempt of repair of the meniscus.
Mitral Annuloplasty Rings RCT

Recently published work has suggested that mitral valve annuloplasty ring type may affect the development of post-repair mitral stenosis resulting in adverse intracardiac hemodynamics and poor functional status. However, these results have not been comprehensively determined in a systematic manner on a general mitral valve repair population. As well, an underlying mechanism for these findings is not understood.

The investigators hypothesize that mitral valve repair with a complete annuloplasty ring (Carpentier-Edwards Physio II) when compared to repair with a partial annuloplasty ring (Simplici- T) may not necessarily result in elevated mitral gradients consistent with functional mitral stenosis (FMS). Currently no prospective data exists to test the hypothesis that a correctly sized, flexible complete annuloplasty ring has detrimental effects.

As 60% of annuloplasty rings used in surgical repair of degenerative mitral valve disease in North America utilizes one of the many forms of complete flexible rings available, this information is urgently required.

The investigators will evaluate: 1) the effect on mitral valve hemodynamics, 2) changes to mitral annular, valvular and subvalvular structure and function with 3D echocardiography, and 3) the effect on patient functional capacity at 1 year.

If FMS early post repair is a real phenomenon, the investigators hope to better understand the mechanisms through the use of advanced imaging techniques-namely 3D modeling of the mitral valvular apparatus, aortic mitral interactions and LV remodeling.


Eligibility Criteria:
Inclusion Criteria:

* Mitral regurgitation secondary to degenerative valve disease referred to Prof Tirone David (Co-investigator) will be invited to take part.
* The mitral valve anatomy must be anatomy suitable for repair.
* The patient must be able to perform treadmill exercise echocardiography.
* The patient must be over 18 years of age.

Exclusion Criteria:

* Any presence of life-limiting disease process, for example advanced malignancy.
* Hemodynamically unstable patients in cardiogenic shock
* Concomitant aortic valve disease/surgery
* Previous mitral valve repair
* Impaired left ventricular systolic function as defined by a left ventricular ejection fraction of ≤ 50%.
* If the patient lives out of state or cannot attend follow up visits.
Use of Hand-held Dynamometry to Obtain Objective Measures of Lower Extremity Force Production With Chronic Stroke

This study wants to know if using handheld dynamometry (HHD) to test leg strength in persons who have had a stroke, will reduce mistakes and give therapists better information to use for therapy. This study will collect normal values of leg muscle peak force production, cumulative peak force production, and sustained peak force production in patients with chronic stroke.

The Activbody Activ5 device will be used for data collection with all information logged and stored through the device's app and transferred to secure files. Assessment of isometric muscle strength and power will be performed as follows:

* Hip flexors with the participant seated and hips and knees flexed at 90 degrees
* Knee extensors with the participant seated and hips and knees flexed at 90 degrees
* Knee flexors with the participant seated and hips and knees flexed at 90 degrees
* Ankle plantarflexors with the participant lying supine with the ankle in plantargrade and hips and knees extended
* Ankle dorsiflexors with the participant lying supine with the ankle relaxed and hips and knees extended
* Hip abductors with the participant lying supine and hips and knees extended
* Hip adductors with the participant lying supine and hips and knees extended
* Hip extensors with the participant lying prone and hips and knees extended 1 session, two trials per side

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Stroke \> 3 months
* Ability to follow two-step commands
* Ability to assume all test positions and maintain for duration of testing (i.e. upright seated, prone, side lying, supine)

Exclusion Criteria:

* Lower extremity contractures preventing full passive range of motion (ROM)
* Vital signs contraindicated for exercise (i.e. resting heart rate \> 100 bpm \< 50 bpm, resting systolic blood pressure \> 200 mmHg or \< 90 mmHg, resting diastolic blood pressure \> 110 mmHg, oxygen saturation \< 90%)
* Symptoms contraindicated for testing (i.e. shortness of breath, angina, dizziness, severe headache, sudden onset of numbness or weakness, painful calf suggestive of deep vein thrombosis)
* Active infection and/or injury at location of testing site
* Other diagnosed co-morbidities that would impact physical participation