cyrilzakka/clinical-trials huggingface dataset:
A Study, Comparing Ruxolitinib Topical Cream 1.5% (Taro Pharmaceuticals U.S.A, Inc.) to OPZELURA (Ruxolitinib) Cream for the Treatment of Mild-to-Moderate Atopic Dermatitis.

To demonstrate the therapeutic equivalence and safety of Ruxolitinib Topical Cream 1.5% (Taro Pharmaceuticals U.S.A, Inc.) and OPZELURA (Ruxolitinib) Cream in the treatment of mild-to-moderate atopic dermatitis

A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing Ruxolitinib Topical Cream 1.5% (Taro Pharmaceuticals U.S.A, Inc.) to OPZELURA (Ruxolitinib) Cream and both active treatments to a placebo control in the treatment of mild-to-moderate atopic dermatitis.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or non-pregnant female aged ≥ 12 years
* Subjects who are 18 years of age or older must have provided IRB approved written informed consent. Subjects 12 to 17 years of age, inclusive, must have provided IRB approved written assent; this written assent must be accompanied by an IRB approved written informed consent from the Subject's legally acceptable representative (i.e., parent or guardian).
* Subjects who have a clinical diagnosis of AD as defined by the criteria of Hanifin and Rajka.
* Subjects who have a clinical diagnosis of AD for at least 2 years.
* Subjects who have IGA Score of 2 (Mild) or 3 (Moderate) for AD severity.
* Subjects who have AD involvement of 3-20% of the body surface area (BSA) and does not include the scalp.

Exclusion Criteria:

* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
* Subjects with a history of hypersensitivity or allergy to Ruxolitinib and/or any of the study medication ingredients
* Subjects with unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline.
* Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of AD (e.g., other types of eczema, pigmentation, or extensive scarring).
Gamma-Irradiated Corneal Inlay for Keratoconus

Study objective is to evaluate the outcomes of placing gamma-irradiated corneal tissue (VisionGraft, CorneaGen, USA) within the cornea of patients with keratoconus, a procedure called Corneal Tissue Addition for Keratoconus (CTAK).

Using E gamma irradiated sterilized preserved corneal tissue, shaped corneal tissue inlays are placed in a keratoconic cornea. Preserved corneal tissue is currently available commercially from CorneaGen (VisionGraft,1200 6th Ave., STe.300, Seattle, WA 98101). Such tissue is currently used in a number of eye surgical procedures. It is considered suitable for corneal surgical procedures that do not require viable corneal endothelium, as is the case for a tissue enhancement procedure in keratoconus. The goal of the current protocol to evaluate the outcomes of placing gamma-irradiated preserved tissue within the keratoconic cornea in order to enhance corneal thickness, stability, and optical conformation.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age, male or female, of any race
* Provide written consent and sign a HIPAA form
* Willingness and ability to follow all instructions and comply with schedule for follow-up visits
* For females: must not be pregnant
* Having topographic evidence of keratoconus which is graded as moderate or severe keratoconus defined as the following:

  * Moderate Keratoconus: Axial topography consistent with keratoconus, Maximum keratometry on Pentacam greater than or equal to 51.01 D
  * Severe Keratoconus: Axial topography consistent with keratoconus with marked areas of steepening, Maximum keratometry on Pentacam greater than or equal to 56.01 D
* Presence of central or inferior steepening on the Pentacam map
* BSCVA less than or equal to 20/25
* Contact lens wearers only: remove contact lenses one week prior to the screening refraction

Exclusion Criteria:

* Contraindications, sensitivity or known allergy to the use of the test article(s) or their components
* If female, be pregnant
* Eyes classified as either normal, atypical normal, keratoconus suspect or mild keratoconus on the severity grading scheme
* Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications. For example:

  a) History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, corneal melt, corneal dystrophy, etc.)
* A history of delayed epithelial healing in the eye to be treated
* Have used an investigational drug or device within 30 days of the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study
Safety and Immunogenicity of Replication-Competent Adenovirus 4-vectored Vaccine for Avian Influenza H5N1

The purpose of this study is to compare the safety and immunogenicity over a 9-month period of five different dosages of Ad4-H5-Vtn in volunteers (Vaccinees) who receive three doses of the study vaccine or placebo. In addition, transmission of Ad4-H5-Vtn will be evaluated in all Household Contacts residing with the vaccinated volunteers.

Vaccinees also may participate in a substudy in which they receive a booster vaccination with the licensed Influenza Virus Vaccine, H5N1 (Sanofi Pasteur).

At least 160 healthy Vaccinees will be randomized into 5 ascending dosage cohorts each consisting of at least 32 volunteers. In each dosage cohort Vaccinees will be randomly assigned to receive 3 doses of either Ad4-H5-Vtn or placebo separated by approximately 56 days. Volunteers will be followed for 168 days post-third vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults and their healthy adult household contacts.

Exclusion Criteria:

* Healthcare workers who have direct contact with patients who are immunodeficient, are HIV-positive, have an unstable medical condition, or are under the age of 18.
* Childcare workers who have direct contact with children 5 years old and younger.
* Resides with Household Contacts who are under the age of 18 or over the age of 65.
* Received or plans to receive licensed inactivated 2009 H1N1 influenza vaccine from 14 days prior to 14 days after any study vaccination.
* Received or plans to receive any other licensed vaccines from 30 days prior to the first study vaccination until 30 days after the third study vaccination.
Present- Versus Past-focused Therapy for PTSD and Substance Use Disorder

This study compares Creating Change, a new past-focused behavioral therapy for posttraumatic stress disorder (PTSD)/substance use disorder (SUD), to Seeking Safety, an evidence-based present-focused behavioral therapy for PTSD/SUD.

This study evaluates a new behavioral therapy model, Creating Change (CC) for PTSD/SUD. CC helps clients explore the past as a step in their recovery process. It has major public health relevance in that it is a low-cost, flexible model designed for all trauma and substance abuse types, both genders, and all clinical settings. It has particular relevance for VA in that many veterans suffer from PTSD and SUD. The new model demonstrated positive results in two pilot studies.

Eligibility Criteria:
Inclusion Criteria:

* Meet Diagnostic and Statistical Manual (DSM-IV) criteria for current PTSD and current substance use disorder
* Have used a substance in the 60 days prior to intake
* Outpatient
* Plan to stay in Boston for the next 6 months
* If on psychiatric medication, are on a stable regimen for at least 4 weeks prior to participation in the study
* Have a stable mailing address and live nearby enough to come to VA Boston for treatment
* Able to sign informed consent
* Willing to participate in all assessments and urine testing
* Willing to provide a release of information for study staff to contact treaters as needed for clinical concerns

Exclusion Criteria:

* Any current acute medical condition that would either interfere with the patient's ability to attend treatment, or would be of such severity as to affect the patient's psychological functioning
* Current bipolar I disorder, schizophrenia or other psychotic disorders, mental retardation, or organic mental disorder
* Any obvious clinical sign that the patient is not sufficiently stable to participate in the treatment, or notification by the patient's primary providers that participation would be contraindicated
* Dangerousness that would present a threat to staff or patients (e.g., history of assault within the past 6 months)
* The patient is mandated to treatment
Early Use of Polymyxin B Hemoperfusion in Abdominal Sepsis

This clinical study designed as a prospective, open labelled, multi-centre, RCT will be carried out to evaluate if direct hemoperfusion with polymyxin B immobilized fiber column (PMX) is superior to conventional medical therapy for sepsis, for patients with sepsis arising from abdominal cavity infection, accompanied by the failure of one or more organs. 120 patients (60 treatment/60 control) will be considered in this study. Those patients fulfilling inclusion criteria and not having exclusion criteria will be randomly allocated to one of two study groups. One group will be treated with PMX (PMX group) and the other will receive a "standard therapy" for sepsis (control group). All patients will receive full intensive care management, including fluid resuscitation, vasopressors, antimicrobial chemotherapy, ventilatory support, and renal replacement therapy, if required. Each patient will be followed up for 28 days after study entry.


Eligibility Criteria:
Inclusion Criteria:

* Patients with severe sepsis due to intra-abdominal cavity infection after emergency surgery with at least 2 SIRS criteria and 1 organ dysfunction (as defined by SCCM)

Exclusion Criteria:

* Less than 18 years of age
* Females with a positive pregnancy test
* Treated with another investigational drug or device within the 30 days immediately preceding enrolment in this study
* Undergone organ transplantation during the past one year
* Documented history of sensitivity to Polymyxin-B, anticoagulant (heparin)
* Terminally ill, including metastases or hematological malignancy, with a life expectancy less than 30 days (as assessed by the attending physician) or have been classified as "Do Not Resuscitate"
* Diagnosed with HIV
* Previous history of end stage chronic organ failure(s)
* Uncontrolled hemorrhage within the last 24 h
* Diagnosed with granulocytopenia (leukocyte count of less than 500 cells/mm3) and/or thrombocytopenia (platelet count of less than 30,000 cells/mm3)
* More than 4 failed organs at entry
* An APACHE II score of more than 30 at entry to the study
High (100IU/Kg) Versus Standard (50IU/Kg) Heparin Dose for Prevention of Forearm Artery Occlusion

This is a prospective, multi-center, superiority study of parallel design. Patients are enrolled if they are older than 18 years old, are scheduled for 5 or 6 Fr diagnostic coronary angiography and the interventional cardiologist is willing to proceed with radial access. Patients are randomized before diagnostic catheterization to receive intravenously either 100IU/Kg or 50 IU/Kg of unfractionated heparin (UFH) in a 1:1 ratio. Patients are discharged usually within 4 to 6 hours after coronary angiography.

Radial artery in each patient is evaluated either in-hospital or during a subsequent visit by one physician who is blinded to the actual antithrombotic treatment given. Radial artery is considered occluded if it exhibits ultrasonographically no antegrade flow signal both at baseline and after reevaluation on a second occasion, within 30 days after the index procedure. Initially patent arteries will not be reexamined and are thought to remain permanently patent. The investigators also monitor major bleeding (defined as ≥ 5g/dL decrease in hemoglobin or ≥15% decrease in hematocrit or any life-threatening bleeding (confirmed by MRI or computed tomography) and large local hematomas of the forearm (defined as those extending beyond the forearm).


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years old
* Scheduled for 5 or 6 Fr diagnostic coronary angiography
* The interventional cardiologist is willing to proceed with radial access
* Written informed consent

Exclusion Criteria:

Before randomization

* chronic hemodialysis
* oral anticoagulation
* hemodynamic instability
* severe dermo-myoskeletal forearm deformities
* history of CABG and bilateral use of either the internal mammary or radial artery
* history of CABG and ipsilateral use of both the internal mammary and radial artery
* admission for elective PCI After randomization
* crossover to another arterial access site is required
* ad hoc PCI
Study of the Effects of Bronchoalveolar Lavage Liquid in the ARDS on the Functioning of the Neutrophil Polynuclear System

Firstly, the study assesses the effect of bronchoalveolar lavage fluid (BAL) from patients in (acute respiratory distress syndrome (ARDS) on the life span of PNNs and on the phagocytosis of apoptotic cells by macrophages and polynuclear neutrophil (PNN).

Then, the effect of an antibody directed against "high-mobility group box 1" protein (HMGB1) and the effect of metformin on efferocytosis are studied.

ARDS (acute respiratory distress syndrome) is a syndrome that causes significant mortality and morbidity. This syndrome is characterized by an alveolitis with polynuclear neutrophil (PNN). PNNs play an important role in the persistence and in injuries induced by ARDS. Several animal studies have shown that lesional edema can be increased by two important mechanisms: the increase in the lifespan of PNNs in the lung and the decrease in the phagocytosis capacities of apoptotic cells (efferocytosis) by macrophages and PNNs.

However, confirmation of these data in humans does not exist, and knowledge of the mechanisms that may increase lung damage during ARDS will limit it and thus reduce the mechanical ventilation time of these patients as well as the mortality associated with ARDS.

" high-mobility group box 1 " (HMGB1) protein may be involved in reducing efferocytosis capacity. Similarly, activation of AMP-activated protein kinase (AMPk) could restore the clearance capacity of apoptotic cells in macrophages and PNNs.

Eligibility Criteria:
Inclusion Criteria:

* ARDS Group : Inpatients hospitalized in medical intensive care with an ARDS defined according to the Berlin criteria and requiring an BAL(for diagnostic purpose in suspicion of pneumopathy acquired under mechanical ventilation).
* Control group : The control population is made up with patients with a BAL considered normal (endoscopy patients from the pneumology department). The normality of the BAL is defined by a normocellular wash with cellularity: \< 150,000 to 200,000 cells/mL Cell composition (formula): macrophages: 80-90%, lymphocytes 5 to 10% (\< 20%), neutrophils: \< 5%, eosinophils: \< 2%.

Exclusion Criteria:

* Age \< 18 years;
* Pregnant women ;
* Persons deprived of their liberty by judicial or administrative decision;
* Persons legally incapable;
* Persons not affiliated to a social security system;
* Previously immunocompromised patients (HIV infection, hematopathy, organ transplantation, immunosuppression);
* Patients who do not require a lung sample.
Adjuvant ChemoRadiotherapy Prior to Surgery in Stage IVa Oral Cancers

Oral cancer is the single largest cancer in males in India. 90-95% cases of oral cancer are Squamous cell carcinomas and many of them present at late stages (T3 and above). Treatment of OSCC includes single modality surgery, radiotherapy, or combinations of these modalities with or without systemic therapy. For unresectable cases, radiotherapy and/or chemotherapy is the treatment modality. Efficacy of neoadjuvant chemoradiotherapy for resectable stage IV tumors (late stage) needs to be evaluated to assess its benefit before surgery.

This study will assess the benefit of preoperative adjuvant chemoradiotherapy in patients with an Stage IVa oral squamous cell carcinoma (OSCC). The study population will consist of patients who have not been treated previously. Patients satisfying the inclusion-exclusion criteria will be included in the study after obtaining a valid, written and informed consent. After reviewing the histopathological report, the patients will be treated as per the study protocol. The patients will be under regular follow-up with 3 monthly intervals for a period of one year and 6 monthly period in the following years. At each follow-up, patients will be evaluated clinically for evidence of locoregional tumor recurrence. The locoregional recurrence-free survival will be calculated based on the difference between the date of inclusion and the date of biopsy-proven recurrence. We will also record the overall survival, parameters like trismus, osteonecrosis and xerostomia. Quality of life will be assessed at a regular interval of 1 year using the University of Washington Quality of Life Questionnaire (UW-QOL v.4)

Study protocol:

1. Preoperative radiotherapy over 5 weeks- Dose 180-200cgys per day/ total 4500 cgys
2. Three weekly concurrent chemotherapy with cisplatin 100 mg /m2
3. Initial surgery in leg for Prefabrication of fibula - 2 weeks after starting of radiotherapy treatment. Delay is required for planning of implant position in the fibula.
4. Definitive surgical procedure with reconstruction by prefabricated flap, 6 weeks post radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed stage IVa squamous cell carcinoma of the oral cavity.
2. Surgically resectable oral squamous carcinoma with invasion of mandible or maxilla.
3. Newly diagnosed or previously untreated squamous cell carcinoma of the oral cavity.

Exclusion Criteria:

1. Patients with distant metastases.
2. Patients with contraindication to radiotherapy.
3. Patients with vascular disorders or ischemic heart disease. -
Interactive Guided Ultrasound Examinations Done by Non-experts of Ultrasound Imaging

This prospective study is a pilot study for evaluating a guidance system that aims to facilitate high-quality echocardiographic acquisitions.

The primary objective of this study is to assess the feasibility for non-expert users (medical professionals but non-certified sonographers) to acquire parasternal, apical and subcostal views of suitable quality by using an existing ultrasound device (CE-marked, available in the market) and an additional guidance system (software prototype + probe motion tracking device). Such a system will help the user to place the probe on the patient and provide guidance for optimal acquisition of parasternal, apical and subcostal views.

The secondary objective of this study is to assess the feasibility for non-expert users to reproduce a simple clinical protocol by using an existing ultrasound device and the same additional guidance system.

Eligibility Criteria:
Inclusion Criteria:

* All volunteers must have the ability to provide informed consent.
* All volunteers should be affiliated to the French Social Security.
* All volunteers will be scheduled for a routine transthoracic echocardiography exam in the echocardiography laboratory at the investigation site as part of standard care.

Exclusion Criteria:

* Subjects with congenital heart diseases (except bicuspid aortic valve)
* Pregnant women
* Adults lacking decisional capacity
* Adults placed under a legal protection regime (guardianship, curatorship, judicial protection)
* Adults not affiliated to the French Social Security
* Adults in emergent or critical condition
* Adults with active pain in the intended scanning region
* Adults with active skin disease or lesions in the intended scanning region
* Adults with allergy/sensitivity to ultrasound gel
Motor-Cognitive Interactive Upper Limb Robot Rehabilitation for Post-Stroke Motor Dysfunction

This study aims to investigate the effects of motor-cognitive interactive robot-assisted training on improving upper limb motor dysfunction after stroke. By observing different combinations of motor and cognitive components in the training, the study will clarify the relationship between the proportion of motor and cognitive elements and the recovery of upper limb motor function. The goal is to optimize the training protocol for upper limb rehabilitation robots and enhance their therapeutic outcomes.

Participants will be randomly assigned to one of three groups: motor-cognitive interactive robot-assisted training, motor-focused robot-assisted training, or conventional rehabilitation training. Training sessions will last 60 minutes, occur 5 times per week, and continue for 4 weeks. Researchers will measure changes in upper limb function and monitor for any adverse events during the training.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of stroke confirmed by CT or MRI.
2. Age between 40 and 80 years, with no gender restrictions.
3. First-ever stroke with unilateral limb paralysis.
4. Onset of stroke between 2 weeks and 6 months prior, with an FMA-UE score of 8-44.
5. Willingness to participate and provide written informed consent.

Exclusion Criteria:

1. History of neuromuscular diseases, malignant tumors, or other severe uncontrolled conditions, including cardiac, renal, or hepatic diseases.
2. Seated balance score \< 2, or inability to maintain a sitting position for more than 60 minutes.
3. Modified Ashworth Scale score \> 2.
4. Visual Analog Scale (VAS) score \> 3 for hemiplegic shoulder pain.
5. Boston Diagnostic Aphasia Examination score \< 3.
6. Severe visual impairment preventing participation in upper limb robot-assisted rehabilitation training.
7. Hamilton Depression Scale score \>17, indicating moderate to severe depressive symptoms.
8. Participation in other clinical trials that may interfere with the results of this study.
UVB-induced Treg Cells Exert Antigen-specific Suppression Through LAG-3

The goal of this clinical trial is to compare the immune cell population in blood of the participants with psoriasis/atopic dermatitis before and after UVB treatment. The main questions it aims to answer are:

1. how immune cells in the PBMCs from blood of participants are affected by UVB treatment
2. will UVB treatment expand the antigen-specific Treg cell population
3. will UVB treatment enhance the suppressive function of Treg cells

Participants giving written informed consent will donate their blood (20 ml) before UVB treatment begins. After 8 to 10-week treatment course, the participants will donate their blood (20 ml) again.

Researchers will compare immune cell population changes in the PBMCs of participants before and after UVB treatment. In addition, researchers will purify Treg cells from participant blood before and after UVB treatment to test their suppressive activity by ex vivo suppression assay.

UVB irradiation suppresses immune responses partly via the induction of Treg cells. However, it is still not clear whether the therapeutic effect of UVB to treat skin inflammatory diseases (such as psoriasis and atopic dermatitis) results from the increase of Treg cell population. In addition, how UVB induces antigen-specific Treg cells needs to be elucidated.

In this study, researchers will examine the Treg cell population in the blood of participants with psoriasis or atopic dermatitis under UVB treatment. We will analyse changes of immune cell populations in the blood of participants using mess cytometry. We will also investigate the suppressive function of Treg cells sorted from peripheral blood mononuclear cells (PBMCs) to see whether UVB treatment will affect the function of Treg cells.

Enrolled participants will donate 20 ml of blood before UVB treatment begins. They will receive UVB irradiation 2 to 3 times per week, and the treatment course will last 8 to 10 weeks, which is defined as a complete treatment. After a complete treatment, the participants will donate 20 ml of blood again, and the trial ends.

Eligibility Criteria:
Inclusion Criteria:

1. At least 20 years of age
2. Able and willing to provide written informed consent

Exclusion Criteria:

1. UV exposure in the last 8 weeks before study entry
2. Patients with contraindications for UV-treatment
3. History of cancer and primary immunodeficiency
4. pregnant or nursing mother
5. participating in another clinical trial