cyrilzakka/clinical-trials huggingface dataset:
One-Month DAPT in CABG Patients

The purpose of this study is to compare the effect of ticagrelor plus low-dose aspirin versus low-dose aspirin alone in patients with chronic coronary disease undergoing coronary artery bypass grafting.

A multinational, randomized trial to evaluate the effect of one-month of ticagrelor plus low-dose aspirin, versus low-dose aspirin alone, on the incidence of death, myocardial infarction, stroke, repeat revascularization and graft failure in patients with chronic coronary disease undergoing coronary artery bypass grafting.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Elective first-time CABG with use of ≥1 saphenous vein graft;
* Ability to sign informed consent and comply with all study procedures, including follow-up for at least 5 years.

Exclusion Criteria:

* Any indication for dual antiplatelet therapy, including

  * Acute/recent (within 1 year) ACS (NSTE-ACS or STEMI)
  * Recent PCI requiring continuation of dual antiplatelet therapy after CABG
* Current or anticipated use of oral anticoagulation;
* Paroxysmal, persistent or permanent atrial fibrillation;
* Any concomitant cardiac or non-cardiac procedure;
* Planned cardiac or non-cardiac surgery within one year;
* Preoperative end-organ dysfunction (dialysis, moderate to severe liver failure, respiratory failure), cancer or other non-cardiac comorbidity with a life expectancy \<5 years;
* Inability to use the saphenous vein;
* Contraindications to the use of aspirin;
* Contraindications to the use of ticagrelor, including

  * Known hypersensitivity to ticagrelor
  * Active pathological bleeding (including, but not limited to gastrointestinal or intracranial bleeding)
  * History of intracranial hemorrhage
  * Concomitant therapy with strong CYP3A4 inhibitors (eg ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir)
* Inability to undergo coronary computed tomographic angiography (CCTA);
* Participating in another investigational device or drug study;
* Women of childbearing potential
* Any major perioperative complication including, but not limited to, stroke, TIA, MI, CABG-related bleeding (BARC type 4), sepsis.
Screening for Social Weaknesses and Coordination Course of Cancer Patients

The main objective of the study is to validate a methodology with Psychometric tool to measure levels of patients social fragility.

This tool will be dematerialized on a tablet. The answers will be then processed by a decision support algorithm, which automatically send an alert to detection of social fragility of the patient to the nurse navigators.


Eligibility Criteria:
Inclusion Criteria:

* All new patients enter ICLN for a diagnosis of cancer
* Patients who can read French or patients who can not read French, but accepting the translation by a close friend or family
* Patient having signed a free and informed consent

Exclusion Criteria:

* Refusal of participation, major patients protected under guardianship.
* Patient can not read French without possibility of translation by a close friend or family
A Brentuximab Vedotin Trial for Patients Who Have Previously Participated in a Brentuximab Vedotin Study

This is a multicenter, open-label study to evaluate the safety and efficacy of treatment with brentuximab vedotin (SGN-35) in patients who have previously participated in an brentuximab vedotin study.

This is a multicenter, open-label study to evaluate single-agent brentuximab vedotin (SGN-35) treatment in patients who previously participated in a brentuximab vedotin study, including Studies SGN35-005 (NCT01100502), SGN35-007 (NCT01026233), and SGN35-008 (NCT01026415). Patients treated on this study (SGN35-006) could re-enroll on study if eligible. The study consisted of 2 arms, as follows:

* Retreatment arm: Patients with CD30-positive hematologic malignancies who experienced a complete remission (CR) or partial remission (PR) with previous brentuximab vedotin treatment on a clinical study and subsequently experienced disease progression or relapse. The purpose of this arm was to assess safety and efficacy of retreatment with brentuximab vedotin.
* Extension treatment arm: Patients with either CD30-positive hematologic or nonhematologic malignancies who completed treatment in a prior brentuximab vedotin study without unacceptable toxicity and experienced clinical benefit as assessed by the investigator. The purpose of this arm was to enable patients who participated in certain prior brentuximab vedotin trials to receive extension treatment and to assess patient safety and survival in the extension treatment setting.

Eligibility Criteria:
Inclusion Criteria:

* Participated in a previous brentuximab vedotin study.
* CD30-positive hematologic malignancy.
* At a minimum, experienced clinical benefit in the prior brentuximab vedotin study. For retreatment, patients must have previously achieved either complete or partial remission with brentuximab vedotin and experienced disease progression after discontinuing the prior brentuximab vedotin study.

Exclusion Criteria:

Withdrew consent to participate in any prior brentuximab vedotin study.
Intravitreal Triamcinolone for Clinically Significant Diabetic Macular Oedema That Persists After Laser Treatment (TDMO)

The trial will test the hypothesis that an intravitreal injection of triamcinolone is safe and efficacious for patients with clinically significant diabetic macular oedema that is recalcitrant to conventional laser therapy

Diabetic retinopathy is a common cause of severe loss of visual and the most common cause of legal blindness in individuals between the ages of 20 and 65 years in developed countries. Swelling of the central retina, or "macular oedema" is the commonest cause of visual loss in diabetic retinopathy.

Diabetic macular oedema is treated with laser coagulation to the macular area according to established guidelines which take into account the extent of the leak and its proximity to the centre of the macula, the "fovea". This treatment does not, however, always work and is inherently destructive.

Intravitreal injection of crystalline steroids has been proposed as a new modality to treat clinically significant diabetic macular oedema.

To determine by means of a prospective, double-masked, randomised, placebo-controlled trial to determine whether an intravitreal injection of triamcinolone three months or more after focal or grid laser photocoagulation for clinically significant diabetic macular oedema will improve the visual acuity of eligible eyes. OCT will be used in addition to visual acuity testing as an objective measurement of macular oedema.

Eligibility Criteria:
Inclusion Criteria:

* Clinically significant diabetic macular oedema involving the fovea in one or both eyes (phakic and/or pseudophakic) which persists at least 3 months after adequate macular photocoagulation.
* best corrected visual acuity in the affected eye(s) 6/9 or worse

Exclusion Criteria:

* Glaucoma which is uncontrolled or is controlled but with glaucomatous visual field defects
* Loss of vision due to other causes (e.g. age related macular degeneration, myopic macular degeneration)
* Significant macular ischemia (FFA)
* No useful vision in fellow eye
* Known allergies to triamcinolone acetate or steroids
* Patient is already under systemic treatment with \> 5mg prednisolone (or equivalent) daily.
* Intercurrent severe disease such as septicaemia
* Any condition which would affect follow-up or photographic documentation (e.g. geographical, psycho-social, media opacities)
Singapore Neurologic Infections Program

Worldwide, central nervous system infections such as inflammation of brain (encephalitis), inflammation of meninges (meningitis) and sudden onset of weakness of muscles which maybe infectious in origin result in significant illness and death and healthcare costs. Vast majority of central nervous system infections remain without an identifiable cause. There is also concern about new and emerging infections.

This study thus intends to fill in the gaps in knowledge with regards to central nervous system infections in Singapore to give a thorough description of burden of causes of central nervous system infections and detection of outbreaks of new pathogens. Patients suspected of central nervous system infection will be recruited from 5 restructured Singapore hospitals and their blood and other clinical specimens will be sent for testing. Patients will also be followed up to assess long term outcomes and socio-economic costs of these infections. This will help clinicians, policymakers and public health officials in estimating financial and societal costs of CNs infections in Singapore.

The study aims to:

1. To describe the epidemiology of CNS infections in Singapore.
2. To improve the diagnosis of aetiologies of CNS infections through a systematic clinical, laboratory and neuro-radiological evaluation and extensive diagnostic testing.
3. To evaluate the prognosis, long-term outcomes and socio-economic costs of CNS infections.
4. To establish an archive of biological tissues from patients with encephalitis and CNS infections that can be utilized for future testing for emerging novel pathogens or non-infectious aetiologies.

The study will recruit 400 patients over 2 years from 5 restructured hospitals in Singapore. As this is not a comparative study, sample size was not determined.

The study involves clinical and laboratory data collection. Data will also be collected on quality of life and for health economic analysis. The quality of data and its integrity will be periodically reviewed by the Principal Investigator and members of the study team. All samples stored will be de-identified and all data will be de-identified during analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical suspicion for Central Nervous system (CNS) infections, OR
2. Any two of the following,

   1. Fever or history of fever (≥ 38 °C) during the presenting illness
   2. Seizures of new onset
   3. Focal neurological deficits
   4. Cerebrospinal fluid white cell count pleocytosis (\> 4 White blood cells (WBC)/uL)
   5. Abnormal neuroimaging suggestive of CNS infection.
   6. Abnormal electroencephalogram (EEG) suggestive of CNS infection
   7. Depressed or altered level of consciousness, OR
3. No alternative aetiology for acute paralysis identified (e.g stroke, trauma, myopathy etc)

Exclusion Criteria:

1. Patient or next of kin unwilling to give consent
2. Patients with indwelling ventricular devices such as EVD (external ventricular drain), VP (ventriculo-peritoneal) shunts
N-Acetylcysteine and Arginine Administration in Diabetic Patients

It has been demonstrated that the nitric oxide production is reduced in type 2 diabetic patients and that cardiovascular complications represent 80% of the causes of death in these patients. As nitric oxide is able to reduce platelet aggregation, increase the relaxation of smooth muscle cells, and reduce plasminogen activator inhibitor-1 and endothelin, we hypothesized that nitric oxide deficiency is responsable for the cardiovascular disease in type 2 diabetes mellitus. Arginine and N-acetylcysteine, precursor and enhancer of the nitric oxide synthesis respectively, are able to increase nitric oxide production.

Aim of the study is to evaluate the effect of arginine and N-acetylcysteine administration on arterial blood pressure and different metabolic parameters in patients with type 2 diabetes mellitus and hypertension.

Subjects and methods. 24 male subjects, randomly divided in two groups, will be studied. These subjects will undergo a treatment with arginine (1200 mg once a day) plus N-acetylcysteine (600 mg twice a day) or placebo for six months. Basal and final evaluations include:

* general examination
* ABPM (ambulatory blood pressure monitoring)
* HbA1c, total-cholesterol, HDL-cholesterol, LDL-cholesterol, oxidized LDLs, triglycerides, reduced/oxidized glutathione ratio in red blood cells, nitrites/nitrates, asymmetrical and symmetrical dimethyl-arginine, nitrotyrosine, arginine, homocysteine, C-reactive protein, interleukin-6, tumor necrosis factor-α, intercellular and vascular-cell adhesion molecules, plasminogen activator inhibitor-1 and fibrinogen
* the ultrasound assessment of the intima-media thickness after endothelium-dependent flow-mediated vasodilation of the brachial artery

Expected results. Increase of nitric oxide production and reduction of arterial blood pressure and oxidative parameters.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects
* Age between 40 and 70 years
* Type 2 diabetes mellitus and hypertension
* Mean 24h arterial blood pressure after the wash-out period: systolic \>136mmHg and/or diastolic \>86 mmHh
* Written informed consent

Exclusion Criteria:

* Female subjects
* Mean 24h arterial blood pressure after the wash-out period: systolic \>180 mmHg and/or diastolic \>110 mmHg
* Secondary hypertension
* Significative cardiovascular complications of diabetes
* Cancer or severe systemic, hepatic, pulmonary, cardiovascular or diseases
* Actual treatment with nitrates, acetylcysteine or arginine
* Acetylcysteine hypersensitivity
* Psychiatric disturbs, abuse of drugs or alcohol
* Low compliance
* Absence of written informed consent
LCAR-B4822M-02 Cells in Treating Relapsed/Refractory (R/R) Multiple Myeloma

This is a single arm, open-label, phase 1 study, to determine the safety and efficacy of LCAR-B4822M CAR-T cells in treating patients diagnosed with refractory/relapsed multiple myeloma (r/r MM).

Multiple myeloma (MM) is a usually incurable malignancy of plasma cells. Current therapies for multiple myeloma often cause remissions, but nearly all patients eventually relapse, there is an unmet clinical needs for these patients. B-cell maturation antigen (BCMA) is a protein expressed by normal plasma cells and the malignant plasma cells of multiple myeloma, and it was supposed to be a promising target for r/r MM.

Eligibility Criteria:
Inclusion Criteria:

- Patients must have a confirmed prior diagnosis of active multiple myeloma as defined by the updated IMWG criteria.

Patients with refractory multiple myeloma. Clear BCMA expression must be detected on malignant plasma cells from either bone marrow or a plasmacytoma by flow cytometry or immunohistochemistry.

Refractory disease：1) At least 3 prior regimens, which must at least have contained bortezomi. or 2) other circumstances identified by clinical doctors.

Relapse criteria in NCCN clinical practice guidelines in Oncology: Multiple Myeloma (2016.V2)

Exclusion Criteria:

- Women of child-bearing potential or who are pregnant or breastfeeding. Have any active and uncontrolled infection: hepatitis B, hepatitis C, HIV, or other fatal viral and bacterial infection.

Systemic corticosteroid steroid therapy of greater than 5 mg/day of prednisone or equivalent dose of another corticosteroid are not allowed within 2 weeks prior to either the required leukapheresis or the initiation of the conditioning chemotherapy regimen.

Patients with any uncontrolled intercurrent illness or serious uncontrolled medical disorder.

Patients with CNS metastases or symptomatic CNS involvement (including cranial neuropathies or mass lesions and spinal cord compression).

History of allogeneic stem cell transplantation. Have active acute or chronic graft-versus-host-disease (GVHD), or require immunosuppressant medications for GVHD, within 6 months of enrollment.

Patients with active autoimmune skin diseases such as psoriasis or other active autoimmune diseases such as rheumatoid arthritis.
Vitamin C Depigmenattion Versus Conventional Technique

Although physiologic gingival hyperpigmentation is not a pathologic condition, it is considered one of the main esthetic problems in dentistry. It was found that the attached gingiva is the most frequently pigmented intraoral tissues followed by the papillary gingiva and the alveolar mucosa

In addition to all of the previously mentioned actions of vitamin C, it was found to be involved in depigmentation due to several factors that not only depend on its direct effect on melanin and melanocytes but also due to the overall effect on the applied tissues. Melanin is one of the main reservoir for ROS, copper and calcium in the tissue cells . Once vitamin C is introduced to the target tissue, it binds efficiently to melanin due to the ROS, calcium and copper content which causes intracellular deficiency of these items and the inability of the cells to produce melanin. Calcium deficiency causes failure of melanocytes to perform cellular adhesion to keratinocytes as calcium is essential to form cadherins . Adhesion to keratinocytes is important stimulator to melanocytes in order to produce melanin, format dendrites and transfer the produced melanin to neighboring cells . Shortage of the intercellular copper limits the formation of tyrosin, tyrosinase enzyme and peroxidase enzyme which in turn stops the melanin production .

Therefore, the aim of the present study is to compare the clinical efficiency of the non-surgical intraepidermal injection of vitamin C in comparison to the gold standard surgical technique (scalpel technique) for gingival depigmentation.

Eligibility Criteria:
Inclusion Criteria:

* aged 18-50 y
* medically free;
* physiologic gingival hyperpigmentation related to esthetic region were selected.

Exclusion Criteria:

All the reasons that could provoke an inflammatory reaction were excluded such as:

* systemic diseases (especially auto-immune diseases and chemotherapy uptake);
* pregnant and lactating mothers;
* usage of chlorhexidine or povidone iodine;
* Local causes (smoking and periodontitis).
A Study to Assess Efficacy and Safety of the Ketoprofen vs Diclofenac

Primary objective:

• To assess therapeutic efficacy of the Ketoprofen compared with Diclofenac based on the assessment of primary endpoint : Mean change in walking arthritis pain intensity score

Secondary objectives:

* To assess therapeutic efficacy of the Ketoprofen compared with Diclofenac based on the assessment of secondary endpoints.
* To assess safety and tolerability of the Ketoprofen compared with Diclofenac based on the nature and frequency of adverse events in treatment groups

This trial is designed as an open-label, multicenter, randomized, clinical study for assessment of efficacy and safety of Ketoprofen plaster and Diclofenac plaster in patients with osteoarthritis

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 40-75 years
* Compliance to ACR diagnostic criteria of OA of the knee
* Patients with Kellgren-Lawrence grade 1-3
* Index knee pain should be ≥40 mm on VAS (100mm) scale

Exclusion Criteria:

* Intolerance or allergic reactions to the study therapy
* Usage of NSAIDs within 3 days
* Open skin lesions or dermatological conditions at the site of plaster application
* Surgery or major trauma of the index knee within the previous 12 months
* Pregnant or breast-feeding women
* Alcohol addiction, drug addiction or drug abuse in the past
Clinical Study of mRNA Vaccine in Patients With Liver Cancer After Operation

This is an open, one-arm study to evaluate the safety and efficacy of mRNA personalized tumor vaccine (tumor vaccine) encoding neonatal antigen in combination with Sintilimab injection for adjuvant prevention of postoperative recurrence of hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Are ≥18 years old (including boundary values), without limitation of sex at time of consent.
* The patient was confirmed as hepatocellular carcinoma by histopathology or cytology after surgery, and the lesion was completely resected by surgery R0 (no residual tumor under postoperative microscope and naked eye), and no residual lesion or extrahepatic metastasis was confirmed by postoperative imaging (CT/MRI).
* The patient is at high risk of postoperative recurrence, and the tumor must meet the following characteristics: Patients with hepatocellular carcinoma IIb/IIIa as defined by the 2019 Chinese Staging System.
* The Eastern Oncology Consortium Physical State Score (ECOG PS) is 0 or 1, and the Child-Pugh rating is A

Exclusion Criteria:

* Known allergy to any tumor vaccine, adjuvant, Stintilimab Injection formulation, fluorouracil inj, oxaliplatin injcalcies;
* Tumor mutation load (TMB) was less than 2.0/Mb or neonatal antigen load (TNB) was less than 0.5/Mb or the predicted number of neonatal antigens was less than 15;
Earlier Diagnosis and Better Treatment Mission Related to the Cohort Programme

The Luxembourg Parkinson's Study is an ongoing longitudinal nationwide monocentric observational study. It collects extensive clinical, molecular, genetic, and digital device-based longitudinal data, as well as foreseen post-mortem diagnostic validation (Hipp et al., 2018). The cohort consists of more than 1,600 participants from Luxembourg and the Greater Region, comprising patients with typical PD or atypical parkinsonism - irrespective of disease stage, age, cognitive status, comorbidities, or linguistic background - followed-up annually and age- and sex-matched healthy control subjects followed-up every 4 years. To provide a large, longitudinally followed, and deeply phenotyped set of patients and controls for clinical and fundamental research on PD, the investigators have implemented an open-source digital platform that has been partly harmonized with other international PD cohort studies. This effort is flanked by comprehensive biosampling efforts assuring high quality and sustained availability of body liquids and tissue biopsies (including blood, urine, stool, saliva, hair, skin biopsy and cerebrospinal fluid). All data and samples are stored, curated, and integrated into state-of-the-art data and biobank facilities.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with neurodegenerative disease or having Parkinson's disease (typical PD or atypical parkinsonism)
* Subjects of all genders with a full capacity of consent
* Subjects with a limited consent capacity if the legal guardian/authorised representative is in agreement
* Subjects of at least 18 years of age at the time of inclusion

Exclusion Criteria:

* Refusal to sign the informed consent
* Limited capacity of consent on the part of the donor, if there is no legally determined guardian/authorised representative, or the latter is not present or does not agree with the inclusion
* Active cancer
* Pregnant women
* Underage subjects of less than 18 years of age
* Refusal to comply with mandatory sample collection
* For invasive procedures, i.e., lumbar puncture and skin biopsy: relevant blood clotting impairment, e.g., anamnestic evidence of frequent or prolonged bleedings.
Pharmacokinetics of Curcumin in Healthy Volunteers

This study looks to describe the pharmacokinetics of curcumin delivered as a single oral dose in healthy female volunteers. The impact of piperine and silybin on the pharmacokinetics of curcumin is also studied.

Healthy volunteers are seen on three separate visits and receive 4 gm of curcumin as a single oral dose either alone or with piperine or with silybin. Serial timed blood draws then are collected for pharmacokinetic analysis.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer
* On no medications except for birth control pills
* Signed informed consent

Exclusion Criteria:

* Pregnant
* Comorbid disease