cyrilzakka/clinical-trials huggingface dataset:
Clinical Outcomes of C3 Glomerulopathy and IC-MPGN in Russia: Hybrid Retrospective - Prospective Study

The study is planned to study specificity of the clinical course and treatment outcomes of C3 glomerulopathy (C3G) and Immune-complex membranoproliferative glomerulonephritis (IC-MPGN) in patients aged under 18 years and 18 years and older in the Russian population in 2025-2028. The primary objective of the study is to estimate the frequency of complete or partial remission 12 months after morphological verification of the diagnosis. Assessment of demographic, clinical and laboratory, morphological characteristics at diagnosis and their relationship with the disease outcomes, primarily the disease progression and development of chronic renal failure, will allow assessing the efficacy of treatment used in real clinical practice, disease prognosis and factors associated with unfavourable outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Willing to sign informed consent form. If the patient is under 18 years of age, the parent or legally acceptable representative of the child/adolescent who can participate in this study also signs the consent form.
2. Diagnosis of primary C3G or IC-MPGN confirmed by the results of morphological and clinical studies.
3. The results of serum creatinine level, proteinuria determination obtained not earlier than 4 weeks before the kidney biopsy
4. Index date (kidney biopsy) not earlier than March 2024 and not later than 11 months before signing the ICF
5. The estimated baseline GFR (using the CKD-EPI formula for persons aged over 18 years and the modified Schwarz formula for children) or the measured GFR is ≥30 mL/min per 1.73 m2.

Exclusion Criteria:

1. Patients participating in a clinical trial with the investigational product.
2. Patients with monoclonal gammopathies (myeloma, B-cell lymphoma/lymphocytic leukemia, lymphoplasmacytoma)
3. Patients with systemic autoimmune diseases and vasculitis (systemic lupus erythematosus, systemic sclerosis, dermatomyositis, mixed connective tissue disease, Sjogren syndrome, Henoch-Schönlein purpura, ANCA vasculitis, cryoglobulinemia)
4. Patients with current or recent infections (viral hepatitis B, viral hepatitis C, infective endocarditis or sepsis, infected ventriculoatrial shunts, abscesses, meningococcal and other bacterial infections, protozoan infections)
5. Patients with any clinically significant acute disease within 30 days prior to kidney biopsy
6. Clinically significant concomitant kidney disease
7. Treatment with pegcetacoplan

Other protocol-defined inclusion/exclusion criteria may apply.
Immunological Markers in Adult Patients With Immune Thrombocytopenic Purpura

The aim of this study is to determine histological immunological parameters, sought on splenectomy pieces that may explain the failure or success of splenectomy in patients with ITP who had a splenectomy to treat their ITP(Immune thrombocytopenic purpura).

Immune thrombocytopenic purpura (ITP) is a rare autoimmune thrombocytopenia whose incidence is 2 to 5 cases / 100,000 inhabitants / year. The potentially serious haemorrhagic risk is the major issue of management. A recent international consensus conference classifies PTI according to the duration of thrombocytopenia: acute ITP (\<3 months), persistent ITP (3-12 months) and chronic ITP (\> 12 months) (Rodeghiero 2009). In the acute or persistent phase, polyvalent immunoglobulins (IVIG) and / or corticosteroids are proposed. In the chronic phase, splenectomy is a possible cure for 70% of patients. No predictor of treatment response is known.

The pathophysiology of ITP is multifactorial: platelet phagocytosis, mediated by autoantibody, macrophages of the reticuloendothelial system, and destruction in the spleen, genetic background and / or environmental factor favoring the role of certain lymphocyte subpopulations, cytotoxic or regulatory T, via their cytokine environment, abnormalities of thrombopoiesis.

At present, no predictive factor of splenectomy success has been identified. The aim of this study is to determine histological immunological parameters, sought on splenectomy pieces that may explain the failure or success of splenectomy in patients with ITP who had a splenectomy to treat their ITP.

Eligibility Criteria:
Inclusion Criteria:

* The analyzed spleens belong to the collection of biological samples declared to the ministry by the Laboratory of Pathology of Haut-Lévêque Hospital (Dr Parrens).

Exclusion Criteria:

* Opposition of the patient.
Osteoporosis Associated Vertebral Fractures - Medical and Socio-economic Aspects in Austria

The purposes of this study were to analyse demographic, medical, gender and socio-economic aspects of osteoporosis associated vertebral fractures.


Eligibility Criteria:
Inclusion Criteria:

-patients older than 50 years of age with vertebral fractures at the thoracic or lumbar spine caused by a low-energy trauma or without any trauma, or with vertebral fractures at the thoracic or lumbar spine with typical osteoporotic deformity of the vertebrae (wedge, fish, or flat)

Exclusion Criteria:

* patients younger than 50 years of age
* vertebral fractures at the cervical spine
* vertebral fractures at the thoracic or lumbar spine caused by a high-energy trauma (motor-vehicle accident, sports-related accident, fall from a considerable height)
* patients suffering from a malignancy, making a pathological fracture presumably, patients with vertebral fractures, whose dataset of follow-up monitoring was lacking, to make an evaluation of osteoporotic involvement impossible
Comparison of Efficacy and Safety of Rimonabant 20mg/Day Versus Placebo in Smoking Cessation

The primary objective is to assess the efficacy a 20mg/day fixed dose of rimonabant versus placebo on abstinence from tobacco use in cigarette smoker.

The secondary objective is to evaluate the effects of rimonabant on craving and weight and on the clinical and biological safety and tolerability of rimonabant in a population of cigarette tobacco smokers during a 10-week treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Smokers smoking at least 10 cigarettes/day as a mean within the 2 months preceding the screening visit
* Motivated to quit with a score greater than or equal to 6 on the ten-point Motivation Scale

Exclusion Criteria:

* Non tobacco cigarettes consumption
* Chronic use of marijuana
* Pregnancy, breastfeeding
* Any clinically significant disease that might interfere with the efficacy or safety evaluation of the study drug
* Concomitant use of drugs as an aid to smoking cessation or that might induce weight change
Effect of Acetaminophen on Neurological Outcome in Acute Ischemic Stroke Patients Undergoing Endovascular Treatment

Neuro-inflammation response plays an important role in the development of acute ischemic stroke(AIS). The aim of this study was to conduct a prospective randomized controlled study on the effect of acetaminophen on long-term neurological prognosis in AIS patients undergoing endovascular treatment(EVT). The primary outcome was the incidence of neurological independence (mRS 0-2, modified Rankin scale) at 90 days after surgery. The secondary outcome measures were early neurological outcome (NIHSS score at 7 days after surgery or at discharge) and the incidence of symptomatic intracerebral hemorrhage during hospitalization. This study explored the effect of acetaminophen on the prognosis of neurological function of patients, and the expected results provide evidence of safety and effectiveness for acetaminophen to improve the prognosis of neurological function of patients, and provide theoretical and practical basis for the subsequent "new use of old drugs" of acetaminophen and large sample and multi-center clinical research or clinical application.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old; computer tomography angiogram (CTA), Magnetic Resonance Angiography (MRA), MRA) or digital subtraction angiography (DSA) confirmed the presence of large intracranial artery occlusion (intracranial internal carotid artery, anterior cerebral artery, M1 and M2 segments of middle cerebral artery, basilar artery, posterior cerebral artery); Endovascular treatment including intra-arterial thrombolysis, mechanical thrombectomy, angioplasty, etc. was performed (within 24 hours of onset). The NIHSS score at admission was 6-26. The mRS Score before onset was less than 2. Patients or their legal representatives provided written informed consent

Exclusion Criteria:

The mRS Score before the stroke was ≥2. Intracranial hemorrhagic diseases: cerebral hemorrhage, subarachnoid hemorrhage, etc. Patients had a history of coagulopathy, systemic bleeding, thrombocytopenia or neutropenia. Renal insufficiency with elevated serum creatinine (\> 2 times the upper limit of normal); Severe hepatic insufficiency or liver disease, with elevations in liver enzymes (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, or gamma-glutamyl transpeptidase) of more than twice the upper limit of the normal range; Patients with severe active liver disease; Patients with severe heart and lung diseases considered by the investigator to be ineligible for the study; DSA examination is contraindicated, severe contrast agent allergy or iodine contrast agent is absolutely contraindicated; Women of childbearing age, pregnant or lactating women who have a negative pregnancy test but refuse to use effective contraception; Inability to complete the study due to mental disorders, cognitive or emotional disorders; Allergy to acetaminophen; Other patients who were not included in the study in the opinion of the investigator (reasons indicated)

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Development and Validation of a Health-related Quality of Life Tool for Patients With Cardiac Sarcoidosis

What is the purpose of this research?

This study includes two parts based in two NHS specialist centres for cardiac sarcoidosis:

* Development of the CARD-SARC: Development of the new questionnaire to measure quality of life in cardiac sarcoidosis patients (the CARD-SARC questionnaire)
* Validation of the CARD-SARC: Evaluation of how good the CARD-SARC questionnaire is at measuring quality of life changes in patients with cardiac sarcoidosis.

What would taking part involve?

First, we would like to talk with a group of patients (between 6 to 20) about the impact of cardiac sarcoidosis in their quality of life during an interview. We will review and analysed these interviews. Then, we will compare with what is already know about cardiac sarcoidosis and its impact on quality of life. Also, we will ask healthcare professionals working with cardiac sarcoidosis patients to review our results. Finally, we will use this information to create the first draft of the new questionnaire (CARD-SARC questionnaire)to measure quality of life in cardiac sarcoidosis patients.

Second, we will ask 20 patients with cardiac sarcoidosis to complete the draft version of the CARD-SARC questionnaire. Also, they will complete validated quality of life questionnaires (for general population or sarcoidosis patients) and questionnaires that explore potential symptoms of fatigue, anxiety and depression. We will compare an review these results to confirm that the CARD-SARC questionnaire is ready for evaluation.

Third, we will ask 100 cardiac sarcoidosis patients to complete the CARD-SARC questionnaire and the validated questionnaires (for quality of life and potential sarcoidosis symptoms) to evaluate how good the CARD-SARC is at measuring quality of life changes in cardiac sarcoidosis patients.

How will patients or the public help guide the research?

This work has been influenced and designed with people living with cardiac sarcoidosis. SarcoidosisUK, the UK sarcoidosis charity, has been supportive and engaged on this work. Likewise, five expert patients with cardiac sarcoidosis have also agreed to lead, contribute and advice on relevant aspects of the study, and to participate sharing the results to the public, patients and professional groups.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 18 years)
* Patients with a probable (50-90% likelihood) or highly probable (\>90% likelihood) diagnosis of cardiac sarcoidosis (CS) by a multidisciplinary team meeting in a CS-specialist centre as per the WASOG criteria
* Patients attending outpatient clinics in a CS-specialist centre

Exclusion Criteria:

* Unable or unwilling to give informed consent
* Unable or unwilling to give and/or complete the study questionnaires • Inability to understand written and/or verbal English
A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human Hyaluronidase

The objectives of the study are to:

1. Evaluate the safety and tolerability of subcutaneously administered CINRYZE with recombinant human hyaluronidase (rHuPH20) in subjects with hereditary angioedema (HAE) who previously participated in CINRYZE Study 0624-200 (NCT01095497)
2. Characterize the pharmacokinetics and pharmacodynamics of subcutaneously administered CINRYZE with rHuPH20
3. Assess the immunogenicity of CINRYZE following subcutaneous (SC) administration of CINRYZE with rHuPH20


Eligibility Criteria:
Inclusion Criteria:

To be eligible for this protocol, a subject must:

1. Provide informed consent/assent, as appropriate.
2. Have previously participated in CINRYZE Study 0624-200 and completed the subcutaneous therapy period in that study.
3. During the 3 consecutive months prior to screening, have a history of less than 1 HAE attack per month (average) that required treatment with C1 INH therapy or other blood products.
4. Agree to avoid his/her known HAE triggers during the study to the best of his/her ability.

Exclusion Criteria:

To be eligible for this protocol, a subject must not:

1. Have received C1 INH therapy or any blood products for treatment or prevention of an HAE attack within 14 days prior to the first dose of study drug.
2. Have received any ecallantide (Kalbitor), icatibant (Firazyr), or antifibrinolytics (e.g., tranexamic acid) within 14 days prior to the first dose of study drug.
3. Have any change (start, stop, or change in dose) in androgen therapy (e.g., danazol, oxandrolone, stanozolol, testosterone) within 14 days prior to the first dose of study drug.
4. If female, have started taking or changed the dose of any hormonal contraceptive regimen or hormone replacement therapy (i.e., estrogen/progestin containing products) within 3 months prior to the first dose of study drug.
5. Have a history of abnormal blood clotting.
6. Have a history of allergic reaction to products containing C1 INH or other blood products.
7. Have a known allergy to hyaluronidase or any other ingredient in rHuPH20.
8. Be pregnant or breastfeeding.
9. Have received an investigational study drug within 30 days prior to the first dose of study drug.
Plaque Modification And Impact On Microcirculatory Territory After Drug-Coated Balloon Percutaneous Coronary Intervention (PLAMI).

Coronary artery disease (CAD) is one of the most common causes of mortality worldwide. Despite drug eluting stents (DES) are the most common treatment strategy, drug-coated balloons (DCB) represent an appealing alternative to DES as they eliminate the risk of stent thrombosis and do not leave any type of metallic structure in the vessel wall. However, the evidence of the vessel wall healing processes, plaque remodeling, plaque composition and impact on coronary microcirculation after PCI with DCB have not yet been characterized.

The purpose of this study is to assess the changes in percentage atheroma volume evaluated by intravascular ultrasound (IVUS) in patients undergoing DCB-PCI.

The study will be an investigator-initiated, single-arm, open-label, pilot study in patients undergoing PCI with DCB for the novo lesion.

Because of the exploratory nature of this study, no formal sample size calculation is required. On the basis of previous pilot studies with similar designs, a sample of 30 lesions is planned to be evaluated.

After being informed about the study and the potential risks, all patients meeting all the inclusion criteria and none of exclusion criteria will give written informed consent. Patients will go DCB-PCI. IVUS will be evaluated prior to PCI-DCB, immediately after and at 3-month follow-up. Angiography-derived coronary physiology will be assessed after the procedure using Angio Plus software (Pulse Medical Imaging Technology, Shanghai, China). The angiography images will be used to obtain the IMRangio values, prior, post to DCB-PCI and 3 month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patient with coronary artery disease undergoing percutaneous coronary intervention with DCB.

Exclusion Criteria:

* Aged \< 18 years.
* Cardiogenic shock.
* ST-segment elevation myocardial infarction.
* Use of mechanical circulatory support.
* Chronic total occlusions, bifurcation lesions, left main coronary artery disease, severe calcified lesions, graft interventions and in-stent restenosis.
* Inability to provide informed consent.
* Unable to understand and follow study-related instructions or unable to comply with study protocol.
* Currently participating in another trial.
* Pregnant women.
Bioequivalence (BE) Study Between YHP2205 and YHR2401 in Healthy Volunteers

A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2205 and YHR2401 in healthy volunteers

60 healthy subjects will be randomized to one of the 2 groups in the same ratio.

Subjects in group 1 will be administered "YHP2205" and "comparator" by crossover design on day 1, 8 Subjects in group 2 will be administered "comparator" and "YHP2205" by crossover design on day 1, 8.

Eligibility Criteria:
Inclusion Criteria:

* Those who are 19 years old or older at the screening visit
* Those whose weight is \> 60kg and their body mass index (BMI) shall be between 18.0 kg/m2 and 30.0 kg/m2
* Those without clinically significant congenital or chronic diseases at the screening visit and without any pathological symptom or opinion after an internal medicine examination
* Those who express their voluntary consent to participate in the trial by signing a written consent

Exclusion Criteria:

* Those who have participated in a bioequivalence study or other clinical trials and have been administered with investigational products in 6 months prior to the first administration.
* Others who are judged ineligible to participate in the trial by the principal investigator.
* Female volunteers who are pregnant, suspected to be pregnant or breastfeeding.
Prospective, Multi-Center, Observational, Whole Blood Specimen Collection Study in Participants with Rheumatoid Arthritis with Inadequate Response or Intolerance to a DMARD Starting a New BDMARD or TsDMARD Treatment +/- CsDMARD

The primary goal of this study is to assess a cfDNA-based blood test using genetic, transcriptomic and/or epigenetic information to help doctors predict the best treatment options for rheumatoid arthritis (RA) patients with inadequate response or intolerance to previous therapies.

PRIMA - 102 aims to predict response to bDMARD or tsDMARD therapy through analysis of cfDNA in blood. PRIMA - 102 will enroll participants with inadequate response or intolerance to previous therapies. Participants will undergo screening and baseline visits, followed by the initiation of new bDMARD or tsDMARD therapy per standard of care. The study will evaluate treatment response and disease activity at a 12-week follow-up visit. Blood will be drawn and Clinical Outcome Assessments performed at baseline and at the 12-week follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and provide written informed consent.
* Male or female ≥18 years of age at enrollment.
* Diagnosis of Rheumatoid Arthritis at the time of enrollment.
* Prior treatment with at least 1 csDMARD, bDMARD, or tsDMARD
* Planning to initiate a new bDMARD (+/- csDMARD) or tsDMARD (+/- csDMARD), within 1 month after enrollment.
* Moderate to high Clinical Disease Activity Index (CDAI) of (\>10) with a minimum 4 tender joints and 4 swollen joints at the time of screening.

Exclusion Criteria:

* Unsuitable for participation in the opinion of the principal investigator.
Irreversible Electroporation(IRE) For Unresectable Extremities Neoplasms

The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Extremities Neoplasms.

By enrolling patients with unresectable Extremites Neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Extremities Neoplasms.

Eligibility Criteria:
Inclusion Criteria:

* Extremities Neoplasms diagnosed by positive biopsy or non-invasive criteria,
* Not suitable for surgical resection,
* Eastern Cooperative Oncology Group (ECOG) score of 0-1,
* A prothrombin time ratio \> 50%,
* Platelet count \> 80x10\^9/L,
* Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
* Able to comprehend and willing to sign the written informed consent form (ICF),
* Have a life expectancy of at least 3 months.

Exclusion Criteria:

* Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
* Any active implanted device (eg Pacemaker),
* Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
* Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
* Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.
Virtual Patient Behavioral Response Training for Family Caregivers

Our study is designed to help caregivers of someone with Alzheimer's Disease and related dementia to understand and deal with the difficult behaviors of a person with dementia.

The goal of this study is to develop and evaluate the Caring Response mobile app, containing a training that builds skills and stimulates practice. The investigators are evaluating different materials, which may encourage caregiver participation, enable user interaction, and promote better assimilation of concepts. The research team is designing the program to help to enhance caregivers' skills to deal with difficult behaviors, reduce distress, and improve quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Care for an individual with Alzheimer's Disease or other dementia.
* Own a smartphone or tablet and have Internet access.
* Minimum age of 18 years old.
* Spend at least 8 hours/week caring for a person with dementia.

Exclusion Criteria:

* Severe psychological or physical illness.
* Inability to read and follow English instructions.
* High level of depressive symptoms.
* Unwillingness to participate in all aspects of the study.