cyrilzakka/clinical-trials huggingface dataset:
A Study of JNJ-64304500 in Participants With Alopecia Areata

The purpose of this study is to evaluate the clinical response of 22 weeks of study intervention with JNJ-64304500, compared with placebo, in participants with moderate to severe alopecia areata (AA).


Eligibility Criteria:
Key Inclusion Criteria:

* Participant has a physician confirmed diagnosis of moderate to severe Alopecia Areata (AA) (greater than or equal to \[\>=\] 50 percent \[%\] scalp involvement) as measured using the severity of Alopecia tool (SALT) score; or participant has \>=95% loss of scalp hair for enrollment as alopecia totalis (AT) or alopecia universalis (AU) subtypes at the time of screening and baseline
* Current episode of hair loss is greater than (\>) 6 months (without evidence of spontaneous terminal hair regrowth within 6 months at the time of screening and baseline), but less than or equal to (\<=8) years
* Medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at either screening or Week 0. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator
* Medically stable on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel or hematology are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator

Key Exclusion Criteria:

* History of liver or renal insufficiency (estimated creatinine clearance below 60 milliliters per minute (mL/min)); significant cardiac, vascular, pulmonary, gastrointestinal, endocrine (except stable thyroid diseases), neurologic, hematologic, rheumatologic, psychiatric disorders, or metabolic disturbances
* Currently has a malignancy or has a history of malignancy (with the exceptions of participants having adequately treated and cured basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ occurring more than 5 years prior to randomization)
* Known allergies, hypersensitivity, or intolerance to JNJ-64304500 or its excipients
* Participants with current episode of hair loss for \>8 years
* Has previous treatment with an oral janus kinase (JAK) inhibitor
Study to Characterize the Effects of Cytochrome p450 1A2 Inhibition on Systemic Exposure to BMS-986165

To compare the pharmacokinetic characteristics of BMS-986165 after a single-dose administration alone vs. in combination with fluvoxamine (CYP1A2 inhibitor)


Eligibility Criteria:
Inclusion Criteria:

* Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations in the opinion of the investigator.
* Body mass index of 18 to 32 kilograms per square meter (kg/m2), inclusive, and body weight ≥ 50 kg, at screening.
* Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) \> 80 milliliter/minute/1.732 meter square calculated with the Chronic Kidney Disease Epidemiology Collaboration formula.

Exclusion Criteria:

* Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study,
* Any major surgery within 4 weeks of study drug administration
* Participants who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on Day 1.
A Prospective, Multi-Center Evaluation of the ENSEAL X1 Large Jaw Tissue Sealer

This prospective, single-arm, multi-center, evaluation will collect clinical data in a post-market setting. The three types of procedures studied will be colectomy, gynecological, and thoracic. Investigators will perform each procedure using the device in compliance with their standard surgical approach and the ENSEAL X1 instructions for use.

The primary objective of this study is to prospectively generate device specific clinical data related to hemostasis in a post-market setting using the ENSEAL X1 per its instructions for use. There will be no blinding or planned interim analysis in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Elective procedure (colectomy, gynecological, or thoracic) where at least one vessel is planned to be transected by the ENSEAL X1 device per its instructions for use;
2. Willingness to give consent and comply with all study-related evaluations and treatment schedule; and
3. At least 18 years of age.

Exclusion Criteria:

1. Physical or psychological condition which would impair study participation; or
2. Enrollment in a concurrent clinical study.
Prescreening Study to Identify Potential Stargardt Participants for ACDN-01 Clinical Trials

This is an observational prescreening study. Individuals who are eligible for prescreening will undergo testing procedures that may be used to determine eligibility in ACDN-01 clinical trials.

The prescreening process will be used to help determine the initial eligibility and interest of potential participants in ACDN-01 clinical trials by conducting assessments of key eligibility criteria before the clinical trial screening procedures are performed.

Eligibility Criteria:
Key Inclusion Criteria:

* Presence of mutations in the ABCA4 gene
* ABCA4 retinopathy phenotype (Stargardt disease type 1 or cone-rod dystrophy)

Key Exclusion Criteria:

* The presence of pathogenic or likely pathogenic mutations in other genes known to cause cone-rod dystrophy or Stargardt maculopathy
* Retinal disease other than ABCA4-related retinopathy
* Presence of a medical condition (systemic or ophthalmic), psychiatric condition, including substance abuse disorder, or physical examination or laboratory finding that may in the opinion of the principal investigator and sponsor preclude adherence to the scheduled study visits, safe participation in the study, or affect the results of the study.
Analgesia of Fibula Free Flap Donor Site by Peri-Neuronal Catheter in Oro-Pharyngeal Carcinoma Surgery

This trial examines the analgesia of the fibula free flap donor site by peri-neuronal catheter in oro-pharyngeal carcinoma surgery by comparing continuous infusion of a local anesthetic with systemic multimodal analgesia.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients scheduled for oro-pharyngeal carcinoma surgery with reconstruction by fibula free flap

Exclusion Criteria:

* Allergy to propofol or local anesthetic (ropivacaine)
* Severe renal or cardiac failure
MiSight 1 Day Safety Post-Approval Study

The purpose of this post-approval study is to confirm the safety of daily disposable soft contact lens wear among the intended patient population for the MiSight 1 Day lens in the US.

This prospective post-approval study of safety in a US study population is to confirm the safety of MiSight 1 day lenses. Consecutive subjects receiving the MiSight 1 Day lens, who meet the inclusion criteria, will be prospectively offered to participate in the study. Additionally, safety data from the MiSight 1 Day Post-Approval Study for Effectiveness and Visual Symptoms (PAS001) will be used to supplement this safety study.

Eligibility Criteria:
Inclusion Criteria:

1. Be between 8 and 12 years of age inclusive at the time of enrollment.
2. Manifest Refraction - Spherical Equivalent Refractive Error (SERE) at baseline between -0.50 D and -7.00 D inclusive (at the corneal plane).
3. Best-corrected visual acuity by manifest refraction of at least 20/25 bilaterally
4. Free of ocular disease or abnormalities (including any corneal scar)
5. The parent/guardian must be capable of comprehending the nature of the study and consent to the use and release of their child's de-identified health care encounter data to be used for purposes of this study. Assent will be obtained from the child in a manner specified by the IRB.
6. Parent/Guardian must sign the Release of Medical Records associated with the outcomes of interest identified from claims data.
7. Interested in wearing contact lenses for approximately 10 hours per day and 6 days per week.
8. Possesses, or obtains prior to dispensing, wearable and visually functional (20/40 or better) eyeglasses.

Exclusion Criteria:

1. Acute and subacute inflammation or infection of the anterior chamber of the eye.
2. Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids.
3. Severe insufficiency of lacrimal secretion (dry eyes).
4. Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic.
5. Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses.
6. Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions.
7. Any active corneal infection (bacterial, fungal, or viral).
8. If eyes are red or irritated.
9. The patient is unable to follow lens handling and wear regimen or unable to obtain assistance to do so.
10. In addition to the labeling contraindications, children who are under medication that would interfere with contact lens wear, or who are using any pharmaceuticals for control of myopia will not be included in the study.
Effectiveness of Glucose Control, β Cell Function in Response to Short-term Insulin Pump Therapy in Type 2 Diabetes

The purpose of this study is to investigate and evaluate the significance of intravenous glucose tolerance test in assessment of β-cell function improvement after short course of intensive insulin therapy, trying to illustrate the relationship between fasting plasma glucose and acute insulin release under different stage of type 2 diabetes with poor glycemic control.


Eligibility Criteria:
Inclusion Criteria: different course of type 2 diabetes with poor glycemic control

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Exclusion Criteria:

* acute complication or severe comorbidities
Telemonitoring in NIV MND (OptNIVent)

This is a feasibility study of telemonitoring system for people with MND/ALS, who are on NIV, via a call centre operated by a local clinical commissioning group.

This study will test the feasibility of previously developed Telehealth system, using a device called Careportal®, to monitor people with MND/ALS who are using non-invasive ventilation (NIV). The Careportal® is a CE marked portable tablet computer device allowing telecommunication between patients and their care team through bespoke question sets, overnight oximetry test, and patient-ventilator interaction(PVI) data. Previously, the weekly telemonitoring via Careportal® was found to be an effective method to monitor symptom changes, allowing clinicians to optimise the care of ventilated patients with MND. This study will assess the practicality of using Careportal® in the care of ventilated patients with MND by monitoring patients through a patient support call centre. The call centre will screen the data and liaise with appropriate clinicians regarding changes of symptoms.

Eligibility Criteria:
Inclusion Criteria (Patients):

* Confirmed diagnosis of MND with respiratory muscle weakness
* Adults who are capable of informed consent
* Patients for whom we anticipate survival of 6 months or more
* Able to communicate with an interviewer. Alternative communication methods will be used as required in order to mitigate communication difficulties.

Exclusion Criteria (Patients):

* Patients who have declined NIV
Corticosteroid Reduction in COPD

This study explores whether patients hospitalized with chronic obstructive pulmonary disease (COPD) exacerbation may have fewer days with prednisolone and with the same treatment effect by controlling the treatment by daily measurements of eosinophils.

The most commonly used treatment for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) is a 5-day treatment with corticosteroids in moderate-high dose. Some patients receive repeated treatments, although it has been shown that corticosteroids only have temporary beneficial effects and no effect in relation to serious incidents or mortality. It has been found that the higher accumulated prednisolone dose disables patients due to serious side effects, including pneumonia, dysregulated diabetes, bone fracture in the context of osteoporosis, mental disorder and adrenal insufficiency etc. However, the extent of the side effects is unknown. Recent research has shown that it is presumably only a small subset of COPD patients who benefit from corticosteroid therapy. This group can be identified by the biomarker "blood-eosinophils" as already measured on most AECOPD patients during hospitalization.

This is a randomized, controlled, multi-center, non-Inferiority trial evaluating the effect of eosinophil guided corticosteroid therapy to patients with AECOPD. The aim of the study is to investigate whether the accumulated dose corticosteroid treatment during admissions for AECOPD can be reduced, including the presumed side effects, while (still) remaining the optimal treatment effect.

Eligibility Criteria:
Inclusion criteria:

* Patients hospitalized with AECOPD
* Age ≥ 40 years
* Spirometry-verified COPD (defined as FEV1 / FVC ≤ 70%)
* Chronic Obstructive Lung Disease (GOLD) class C or D
* Inclusion within 24 hours after admission

Exclusion criteria:

* Known with a diagnosis of asthma
* Life expectancy less than 30 days
* Serious exacerbation requiring invasive ventilation or admission to ICU
* Allergy to systemic corticosteroids
* Severe mental illness, which is not controlled by medication
* People who are detained under the act on the use of coercion in psychiatry
* Severe language problems or inability to provide written informed consent
* Pregnancy and lactation
* Systemic fungal infections
More Effective Violence Risk Management - eDASA+APP FI

The main goal of this study is to evaluate if the Finnish version of eDASA+APP (electronic Dynamic Appraisal of Situational Aggression + Aggression Prevention Protocol), a clinical decision support system (CDSS), has an impact on reducing workplace violence, use of coercive measures and increasing nurses' job satisfaction in adult psychiatric inpatient care.

The study includes three phases: 1) exploring attitudes of nurses and nurse managers towards validated tools, violence risk assessment and management, 2) a pre-implementation including a co-design process of the eDASA+APP to ensure optimal integration and adaptation to local context and integration into the local EPIC based EHR system together with relevant stakeholders (health care staff and expert-by-experience), and 3) a quasi-experimental implementation study to evaluate the impact of the intervention (eDASA+APP FI).

Eligibility Criteria:
Inclusion Criteria:

* adult psychiatric wards

Exclusion Criteria:

* psychiatric wards specialized only for the care of people with intellectual disabilities, wards providing care for both adults and underaged patients (eating disorder units)
Impact of Ketoflex 12/3 Diet on Parkinson's Disease Symptoms: A Clinical Study

This study aims to investigate the effects of the Ketoflex 12/3 diet on motor and non-motor symptoms in patients with Parkinson's disease. Participants will follow the Ketoflex 12/3 dietary regimen, and their cognitive function, motor symptoms, sleep patterns, gastrointestinal health, and overall well-being will be assessed through standardized clinical scales. The study will help determine whether a plant-based ketogenic diet combined with intermittent fasting can have a beneficial impact on Parkinson's disease progression.

Parkinson's disease is a progressive neurodegenerative disorder characterized by motor and non-motor symptoms. Emerging evidence suggests that dietary interventions, particularly ketogenic diets and intermittent fasting, may play a role in neuroprotection and symptom management. This study investigates the effects of the Ketoflex 12/3 diet, a plant-based ketogenic dietary approach combined with intermittent fasting, on Parkinson's disease progression. Clinical assessments will include Unified Parkinson's Disease Rating Scale (UPDRS), Mini-Mental State Examination (MMSE), depression and anxiety scales, sleep quality assessments, and gastrointestinal health evaluations. The study aims to provide new insights into the potential benefits of metabolic-based nutritional interventions in Parkinson's disease patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Parkinson's disease
* Age between 40-85 years
* Native Turkish speakers
* Able to comply with the study protocol

Exclusion Criteria:

* History of alcohol or substance dependence
* Diagnosis of chronic renal failure
* Presence of neuromuscular disorders
* Having amalgam dental fillings and/or failure to remove them according to the SMART protocol
* Severe vitamin deficiencies that have not been corrected prior to the study
Transcriptomal and Molecular Characterization of Tumor Associated Monocytes/Macrophages in Human Cancers

Recent studies from both human and mice cancer models have demonstrated a crucial role for monocytes/macrophages in contributing to cancer progression and disease prognosis. However, since each cancer subtypes is associated with a unique tumor microenvironment in terms of its anatomical location, cytokine/chemokine profiles and stromal components, the functional contribution of tumor infiltrating cells such as the monocytes/macrophages can be equally diverse, depending on the type of cancer. Therefore to obtain a global understanding of the role of host immune cells in cancer progression, it is necessary to accurately characterize these cells in the context of the tumor microenvironment for several cancer subtypes rather than a single cancer. In view of this, this pilot proposal aims to carryout a systems approach in characterizing the functional phenotype of monocyte/macrophage lineage in 4 diverse human cancer types \[e.g., Colorectal Cancer, Nasopharyngeal carcinoma, Hepatocellular (liver) cancer and Renal cell carcinoma (kidney cancer)\] and the molecular basis of tumor-induced immunosuppression in each of these conditions. Besides providing a global view of the host innate immunity and its molecular basis in these human cancer, the outcome of this investigation will be crucial in defining the scopes of specific immunotherapy strategies to overcome tumor-induced immunosuppression and induce monocyte/macrophage-mediated antitumor response.


Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all of the inclusion criteria to participate in this study:

* Diagnosed NPC, RCC, HCC or colorectal cancer patients. (Preoperative histologic diagnosis is not required for RCC and HCC.)
* All stages of disease are eligible.
* Adult patients above 21.
* Ability to provide informed consent.

Exclusion Criteria:

Subjects meeting any of the exclusion criteria at baseline will be excluded:

* Active infection.
* Immunocompromised or other active immune disorders.
* Have received chemotherapy or other immunomodulating therapy in the past 6 months.
Anecortave Acetate in Patients With Open-angle Glaucoma

The purpose of this study is to evaluate the safety, efficacy, and duration of effect of a single administration of Anecortave Acetate Depot for treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older with open-angle glaucoma.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Patients with open-angle glaucoma with a pseudoexfoliation or pigment dispersion component.
* Other protocol-defined exclusion criteria may apply.
Multicenter, Open, Prospective, 48 Weeks, Observational Study ,Evaluate the Safety and Efficacy of Nephoxil Capsule

The purpose of this study is to evaluate the safety and efficacy of Nephoxil capsule administration for the improvement of hyperphosphatemia in CKD patients undergoing hemodialysis under actual conditions of routine medical care.

This study is a prospective observational study, and only observable information is collected during Visits 1 to 13 of the subjects' routine outpatient visits. Therefore, no further visits related to this study are planned, and all treatments, examinations, and evaluations necessary for the subjects shall be conducted at the discretion of the investigator.

The initial dose of Nephoxil capsules for the subjects participating in this study shall be determined at the investigator's discretion, and subjects shall be classified into either the low-dose group (1.5 g/day) or the standard-dose group (4 g/day) according to the initial dose. During the observation period, dose titration within 1 g may be performed at the investigator's discretion, and in such cases, the maximum dose per day shall not exceed 6 g.

Eligibility Criteria:
Inclusion Criteria:

1. Adults 19 years of age or older as of the ICF date
2. CKD patients undergoing hemodialysis to whom Nephoxil capsule shall be administered for the first time for the treatment of hyperphosphatemia as per the determination of the investigator
3. Patients who voluntarily decide to participate in this study and complete the ICF

Exclusion Criteria:

1. Those who fall under the "Do not administer to the following patients" criteria according to Nephoxil capsule indication approval
2. Those who require concomitant administration of aluminum-containing medication
3. Others determined by the investigator to be unsuitable for participation in this study
Preventing Esophageal Stent Migration in Esophageal Strictures

This study aims to assess the efficacy and rate of stent migration in standard of care esophageal stents that are not fixed, compared to those that are fixed with either standard of care OTSC stentfix or standard of care stent placement with suturing in both benign and malignant esophageal strictures.


Eligibility Criteria:
Inclusion Criteria:

1. The study population will include any adult (18 years +) who will undergo standard of care esophageal stent placement for benign or malignant esophageal strictures as either an inpatient or outpatient at NYULH.
2. The participant is able to consent to stent placements with fixation or without fixation and study procedures, verified by signature on the informed consent form.
3. Willing to comply with all study procedures and be available for the duration of the study.
4. English and Non-English speaking participants.

Exclusion Criteria:

1. Patients who have strictures treated with luman apposing stents.