cyrilzakka/clinical-trials huggingface dataset:
Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sjögren's Syndrome

The primary objective of this study is to evaluate the efficacy of treatment with either lulizumab or BMS-986142 versus placebo in subjects with moderate to severe primary Sjögren's syndrome as measured by the change from baseline in ESSDAI at Week 12 between active treatment arms (lulizumab or BMS-986142, respectively) and the placebo arm.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Subjects diagnosed or classified as having moderate to severe primary Sjögren's Syndrome based on the 2016 ACR-EULAR Sjögren's Syndrome Classification Criteria for at least 16 weeks prior to screening
* ESSDAI ≥ 5 including disease activity (any score \> 0) in at least one of the following domains: Glandular, Articular, Hematological, Biological, Lymphadenopathy
* Positive anti-SS-A/Ro and/or anti-SS-B/La autoantibody
* Unstimulated whole saliva secretion \> 0.01 ml/min
* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug and must not be pregnant or breastfeeding. Male and female subjects must be willing to adhere to protocol-mandated highly effective contraception for the duration of the study and for the protocol-specified follow up period. Hormone-based contraceptive methods are not permitted

Exclusion Criteria:

* Secondary Sjögren's syndrome or the presence of any other systemic autoimmune disease (eg, RA, SLE, multiple sclerosis, vasculitis)
* Very severe primary Sjögren's syndrome or severe complications of primary Sjögren's syndrome at the time of the screening visit
* Active systemic or latent bacterial (including tuberculosis), viral or fungal infection, evidence of current or chronic Hepatitis B or C infection, or HIV infection
* Any significant concurrent medical condition at the time of screening or baseline visit
* Use of methotrexate, cyclophosphamide, cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil (MMF) or leflunomide within 12 weeks of screening visit
* Previous treatment with biologics therapies either marketed or in development within 6 months prior to screening visit
* Treatment started or an unstable dose of hydroxychloroquine within 8 weeks of screening visit
* Oral corticosteroids \> 10 mg/day within 14 days of dosing (Day 1), corticosteroid therapy ≥ 1 mg/kg during the 4 weeks preceding enrollment, or intravenous, intramuscular or intra-articular corticosteroids within 4 weeks of screening visit

Other protocol defined inclusion/exclusion criteria could apply
Endodontic Microsurgery With the Use of L-PRF and an Occlusive Membrane: a Randomized Controlled Clinical Trial

This study evaluates the effect of leucocyte and platelet rich fibrin (L-PRF) during endodontic microsurgery (EMS) on patient's post-operative comfort and periapical bone healing. Also the influence of an occlusive membrane barrier in EMS on the periapical bone healing will be studied. The trial design is an open randomized controlled clinical trial with a 2x2 factorial design. Half of the participants will receive EMS with L-PRF (experimental group), the other half without (control group). The control and experimental group will be divided in 2 subsequent groups: half of the participants will receive an occlusive membrane during EMS, the other half not.


Eligibility Criteria:
Inclusion Criteria:

* Provision of Informed Consent
* Patients in need of an EMS
* EMS is the only option to cure the periapical lesion

Exclusion Criteria:

* Unlikely to be able to comply with the study procedures, as judged by the investigator
* Orthograde endodontic (re)treatment is indicated
* Known or suspected current malignancy
* History of chemotherapy within 5 years prior to study
* History of radiation in the head and neck region
* History of other metabolic bone diseases
* History of bleeding disorders
* HIV disease
Evaluation of the Prevalence of Functional Digestive Disorders During Primary Sjögren Gougerot Syndrome

the investigators propose to carry out a prospective study consisting of a systematic research of digestive symptoms in patients with SGSp with the validated Global symptom score (GSS) questionnaire, which allowed to grades severity of 10 digestive symptoms (absent, mild, moderate, or severe), asthenia and fever.

Primary Sjögren syndrome (SGSp) is an autoimmune disease defined by the association of sicca syndrome in the absence of other connective tissues (ie rheumatoid arthritis, systemic lupus erythematosus, scleroderma, dermatopolymyositis). SGSp is complicated by several visceral involvements (pulmonary, renal, neurological, systemic vasculitis ...) and by a chronic alteration of the quality of life related to asthenia, chronic pain and sicca syndrome. Two European-validated scales are currently used in daily clinical practice to assess these two facets of the disease, respectively EUSSAR Sjogren's Syndrome Patient Reported Index (ESSPRI) and ESSDAI (EULAR Sjögren's Syndrome Disease Activity Index). Neither of these two scores evaluate the digestive impairment. Indeed, digestive complaints have been evaluated in a few studies, with a prevalence of 30 to 65%. The precise etiopathogeny of such digestive involvements remains unknown.

Eligibility Criteria:
Inclusion Criteria:

* Patients with SGSp according to revised American-European criteria
* Patients 18 years of age or older
* Patients affiliated to the French social security care system.

Exclusion Criteria:

* Patients under measure of maintenance of justice.
* Patients unable to understand or to participate to the study.
* Child and major patients making the object of a measure of lawful protection.
* Patients deprived of freedom.
* Concomitant interventional clinical trial
Effect of Lactoferrin Supplementation on Urinary Tract Infections in Infants.

The aim of the study was to evaluate the efficacy of orally administered bovine lactoferrin (bLF) on Urinary Tract Infections in neonates and infants. Fifty-five patients with urinary tract infection were randomized to receive either bLF (n = 27) or an identical placebo (n = 28) for 4 weeks. The patients were assessed clinically and laboratory.

This study was a prospective randomized controlled trial at a single university medical center. Participants were neonates or infants with Urinary Tract Infection (UTI) admitted to the Neonatal and Infant Pathology Department of Children's University Hospital in the period from July 2015 to December 2017. The intervention was bovine lactoferrin at a dosage of 100 mg/day for a period of 4 weeks compared with placebo in a control group.

During hospital treatment, laboratory tests were performed to evaluate the activity of inflammatory markers (C-reactive protein, procalcitonin, Interleukin-6 and Interleukin-8 levels and white blood cell count).

Fifty-five patients heve been included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Neonates and infants with symptoms of Urinary Tract Infection.
* Active infection at enrollment, confirmed and documented in medical record.
* Children with Urinary Tract Infection treated according to current recommendations.

Exclusion Criteria:

* Unconfirmed Urinary Tract Infection.
* Critical illness and/or hemodynamic instability.
* Allergy or sensitivity to lactoferrin or bovine derived proteins or bovine milk.
* Children whose parents/guardians decline to participate.
Feasibility of a Smartphone Application for Asthma Self-management

The primary goal of this project is to determine the feasibility, acceptability, and adherence of a smartphone application for improving asthma self-management in a pilot randomized controlled trial (RCT). The app is specifically designed to appeal to adolescents. Adolescents with persistent asthma will be randomized to receive: 1) standard-of-care or 2) the self-management app in addition to standard-of-care. Feasibility will be assessed by the ability to recruit and retain subjects, technical barriers to implementation, and the appropriateness of the intervention among adolescents and providers. The acceptability of the intervention will be determined by appraising perceived usefulness, entertainment, and ease of use of the app. Adherence to usage of the app over a 6-month period will be assessed by examining the frequency of app usage and the features that were used, and the extent of data regarding self-management that was entered. A secondary objective is to obtain preliminary estimates of effectiveness of the app on clinical outcomes (ACT score, spirometry, CHSA-C, exacerbations, and medication adherence) relative to standard-of-care. It is hypothesized that the app will result in a high level of adherence and will be a feasible and acceptable intervention to improve self-management among adolescents with persistent asthma.


Eligibility Criteria:
Inclusion Criteria:

* At least 12 and less than 18 years at enrollment
* Established mild, moderate, or severe persistent asthma with a diagnosis verified by clinic physicians
* Speak English
* Not planning on moving out of the Tampa Bay area during the trial period
* Must have a suitable iPhone or Android device available to use with the app

Exclusion Criteria:

* Having mental or other development disorder that may make self-management of a chronic condition difficult
* Having other chronic lung disease or one or more of the following disorders including cystic fibrosis, neuromuscular disease, immunodeficiency or autoimmune disorders, blindness or severe vision impairment that may interfere with the ability to use the mobile app
* Having participated in the app development phase of the funded project
Auricular Acupressure Therapy for Patients With IC/BPS

The purpose of this study is to determine the feasibility of administering auricular acupressure for patients with interstitial cystitis/bladder pain syndrome (IC/BPS), and evaluating the efficacy of auricular acupressure to reduce pain scores and decrease pain medication usage over time.

Eligible participants will be asked to complete baseline questionnaires. After completion, a study interventionist will place 10 adhesive acupressure pads/seeds on the participant's ears (5 on each ear). Each seed will be placed on a specific site on the ear believed to help with pain and overall well-being. Over the course of 5 days, participants will be asked to apply a small amount of manual pressure with their fingers to each of the ear pads and answer daily study questionnaires.

This feasibility trial is being conducted in collaboration with the Battlefield Auricular Acupressure (BAApress) Training and Intervention Fidelity study (IRB00084011).

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* History of documented interstitial cystitis/bladder pain syndrome (IC/BPS)
* Able to read and understand informed consent form in English

Exclusion Criteria:

* Patients with a history of skin disease (e.g. psoriasis) involving the ear, adhesive allergy, recent scar tissue on ear, or current abrasions or cuts on the ear
* Cognitive impairment (e.g. delirium, dementia)
* Physical impairment preventing them from applying daily pressure/stimulation to ear seeds
* Patients with cardiac pacemakers (contraindication to POINTER PAL)
* Use of some types of hearing aids (which could potentially obstruct placements of ear seeds)
* Any acute illness or psychiatric conditions that would impact adherence to the study requirements
Comparative Effects of Tai Chi vs Full Body Vibrator Among Athletic Players

The aim of this study is to find out the Comparative effects of Tai chi and dynamic stretching exercises in reducing stress and insomnia among ameature athletics player's.

In previous researches, little literature is available regarding comparison of the effectiveness of tai chi on insomnia and static balance among players.There is a dire need to explore the comparative effects of Tai chi and dynamic stretching exercises in reducing stress and insomnia among ameature athletics player's.

Eligibility Criteria:
Inclusion criteria:

* Female
* 17-35 years age
* Players with 2-3 years of experience in sports
* Minimum sports activity 1 hour 4 times a week

Exclusion criteria:

* Recreational players
* Players with recent injuries in the past 6 months
* Any neurological problem
* Player addicted to any drug or alcohol will be excluded
Evaluation of an IgG Deficiency Rapid Screening Test: A Performance Study With Primary Immunodeficiency (PID) Patients in Tunisia

To evaluate the usability and utility of the device, % agreement between the PID-RDT and the referent assay (serum/plasma), and % agreement between capillary blood and venous blood samples using the PID-RDT within confirmed PID patients prior to receipt of their monthly IV-Ig treatment.


Eligibility Criteria:
Inclusion Criteria:

* Must be 6 months of age.
* The types of PID presenting for IV-Ig therapy will include Evaluation of PID RDT with human capillary blood (version 1.0) \| 8agammaglobulinemia (AG), hypogammaglobulinemia (HAG), common variable immunodeficiency (CVID), and hyper IgM syndrome (HIGM).

Exclusion Criteria:

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Multimodal Prehabilitation in Colorectal Cancer Patients

Postoperative complications can occur in up to 50% of individuals undergoing colorectal resection and are associated with poor prognosis, increased costs, and lower health-related quality of life. Even in the absence of complications, after major surgery, patients reduce their physiological and functional capacity by 20-40% and show a higher level of fatigue for 6-8 weeks. Many of these negative effects can be decreased by applying specific ERAS (Enhanced Recovery After Surgery) programs which, by attenuating the neuro-endocrine response induced by surgical trauma, accelerate patients\&#39; post-operative convalescence and facilitate their return to functional activities.

In this study, the research group hypothesizes that a prehabilitation program based on physical exercise, nutritional optimization and psychological support (trimodal) carried out by patients in the 4 weeks before elective colorectal resection surgery can determine: 1) better physical performance 8 weeks after surgery (measured by the 6-minute walk test), 2) a possible decrease in postoperative complications, and 3) a reduction in in-hospital (direct) and post-hospital discharge (indirect) costs.

This study aims to determine the effect of prehabilitation on patients\&#39; functional capacity and postoperative complications. It is a randomized trial including 112 patients undergoing colorectal surgery for cancer. Patients will be allocated to intervention group receiving 4 weeks trimodal prehabilitation (N=56) or control group receiving no prehabilitation (N=56). After surgery, both groups will follow 8 weeks rehabilitation based on Enhanced Recovery After Surgery (ERAS) guidelines. The primary endpoint is functional capacity, secondary outcomes include postoperative complications and a cost-effectiveness analysis. Multimodal prehabilitation is expected to increase functional capacity and lower postoperative complications.

Eligibility Criteria:
Inclusion Criteria:

* patients of age \&gt;18 years;
* elective colorectal resection for colonic cancer.

Exclusion Criteria:

* metastatic disease;
* severe walking impairments;
* renal failure stage \&gt;2;
* ASA score \&gt;3;
* preoperative chemo-radiation therapy.
Autologous Tolerogenic Dendritic Cells for Treatment of Patients With Rheumatoid Arthritis

Tolerogenic dendritic cell (tDC)-based clinical trials for the treatment of autoimmune diseases are now a reality. Clinical trials are currently exploring the effectiveness of tDC to treat of type 1 diabetes mellitus, rheumatoid arthritis, multiple sclerosis and Crohn's disease. The general objective of this study is to evaluate the safety and tolerability of a single intra-articular injection (into the knee joint) of autologous monocyte-derived dendritic cells generated in the presence of interferon-alpha (IFN-α)/granulocyte-macrophage colony-stimulating factor (GM-CSF) and tolerized with Dexamethasone in rheumatoid arthritis (RA) patients.

A phase I dose-escalating clinical trial will be conducted to determine the safety and tolerability of a single intra-articular injection (into the knee joint) of autologous tolerogenic dendritic cells, and to enable selection of a suitable dose regimen for phase II trial. The primary objective of the phase I study will be to determine whether tDC-based therapy is safe and well tolerated and to establish the dose-response with disease activity measured over 6 months. Patients will serve as their own controls (pre- and post-treatment). Five doses of tDCs will be tested. The Study will start with intra-articular injection (into the knee joint) of 1x106 cells. Depending on safety/tolerability outcomes, the dose will gradually increase to 3x106, 5x106, 8x106 and 10x106 cells. The safety will be determined by the evaluation of the number of participants with adverse events (AEs) and severe adverse events (SAEs) following the intra-articular administration of tDC (within 6 months of injection). Systemic RA disease activity will be measured using DAS28 (Disease Activity Score using 28 joints) and the Health Assessment Questionnaire (HAQ), a standard instruments used in RA. Patients will be monitored at baseline and at 3, 7 days and 1, 3, 6 months post treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 75 Years
* Patients with moderate to severe active RA (DAS28 \>=3.2)
* At least 6 month's disease duration
* Synovitis of large joints (knee, elbow)
* Morning stiffness in the target joint ≥ 30 minutes
* Stable dose of disease-modifying anti-rheumatic drugs (DMARD) for ≥16 weeks
* Patients must be able to tolerate all study procedures
* Patients must be willing to voluntarily give written Informed Consent to participate in the study before any procedures are performed
* Patients must be willing to be available for all baseline, treatment and follow-up examinations required by protocol

Exclusion Criteria:

* Injection of target joint with glucocorticoids within 6 weeks of baseline
* Known hypersensitivity to gentamicin or local anaesthetics
* Dementia, psychiatric disorders
* Renal dysfunctions
* Hemodynamic or respiratory instability
* HIV or uncontrolled bacterial, fungal, or viral infections
* Pregnancy
* Malignancy
* Participation in other clinical trials
A Study for Obstructive Sleep Apnea Using a New At-Home Sleep Test

The purpose of the study is to test the workflow of an auto-titrating mandibular positioner in its intended setting. Participants with obstructive sleep apnea will use the device to determine their eligibility for oral appliance therapy and provide feedback on usability of the device.

One treatment for obstructive sleep apnea is oral appliance therapy during sleep, in which an appliance that covers the upper and lower teeth acts to pull the lower jaw forward, opening the throat passage and allowing for normal breathing. However, oral appliance therapy does not treat sleep apnea effectively in all individuals. In order to identify those individuals for whom oral appliance therapy will work, the study sponsor has developed an investigational device called an auto-titrating mandibular positioner.

The device automatically pulls the lower jaw forward in response to respiratory events while the individual sleeps. Study participants will learn the outcome of their sleep tests and will provide feedback on the ease of use of the device.

Eligibility Criteria:
Inclusion Criteria:

1. Minimum 18 years of age
2. Participant has been deemed suitable for oral appliance therapy
3. Prescription for oral appliance
4. Adequate range of motion
5. Adequate dentition
6. Ability to understand and provide informed consent
7. Ability and willingness to meet the required schedule

Exclusion Criteria:

1. Loose teeth or advanced periodontal disease
2. Full dentures
The Role of miRNA in Group 3 Pulmonary Hypertension

This study recognizes the substantial value of lung tissue obtained from explanted lungs for fundamental research purposes.By analyzing pulmonary tissue affected by pulmonary hypertension, it is possible to discover shared pathogenetic mechanisms between these two groups and to gain a deeper understanding of the mechanisms underlying pulmonary hypertension.

Lung transplantation serves as the sole therapeutic approach targeting the enhancement of life expectancy and quality of life for individuals afflicted with advanced parenchymal or vascular lung diseases. The current study aligns with this objective, recognizing the substantial value of lung tissue obtained from explanted lungs for fundamental research purposes. By investigating lung tissue affected by both group 3 and group 1 pulmonary hypertension, it becomes possible to uncover shared pathogenic mechanisms between these two groups and gain a more profound understanding of the underlying mechanisms driving group 3 pulmonary hypertension. Furthermore, delving into the cells responsible for the expression of dysregulated miRNAs offers the potential to identify novel target mechanisms for the clinical management of group 3 pulmonary hypertension, an area currently limited in therapeutic options. Through a comparative analysis of the quantitative expression patterns of each miRNA among distinct groups, it becomes feasible to determine the extent of involvement of specific pathogenic pathways in the various forms of pulmonary hypertension. Consequently, this approach provides guidance for future research, directing focus towards the most relevant mechanisms of interest.

Eligibility Criteria:
Inclusion criteria

* Patients who underwent lung transplantation at the AOU IRCCS Policlinico Sant'Orsola in Bologna and the IRCCS Fondazione Policlinico San Matteo in Pavia (satellite center) from January 1, 2010, to December 31, 2021.
* Diagnosis of idiopathic pulmonary arterial hypertension, idiopathic pulmonary fibrosis, or chronic obstructive pulmonary disease.
* Patients who underwent at least one pre-transplant right heart catheterization in clinically stable conditions, with findings of mPAP ≥ 25 mmHg, PVR \> 3 WU, and PCP \< 15 mmHg.
* Suitability of lung explant tissue available in the archives of the participating pathology departments: presence of at least 3 pulmonary arterioles in each specimen.
* Acquisition of informed consent. Exclusion criteria
* Unsuitability of lung tissue for molecular biology investigations (due to preservation issues or deterioration of the necessary arteriolar structures).
* Patients with active neoplastic diseases.