cyrilzakka/clinical-trials huggingface dataset:
IDA (Immunothérapie de la Dermatite Atopique) Adult - Immunotherapy in Atopic Dermatitis

Atopic dermatitis (AD) is a chronic inflammatory disease of the skin. AD is very frequent, and involves T lymphocytes cells. Measles vaccination, as well as measles vaccine, induces a temporary immunosuppression; furthermore, an improvement of AD has been observed during measles infection.

This trial is aimed at demonstrating that measles vaccine is able to create an immunomodulation and to improve AD symptoms.

30 adult patients of both sexes with moderate to severe AD will be randomly assigned to measles vaccine (ROUVAX ®), or placebo (vehicle) and follow-up for 45 days.

The primary outcome is the effect of anti-measles vaccination on the T cell responses in patients; Other outcomes include: clinical evolution of AD, as measured by the SCORAD, the evolution of blood level of measles specific IgE and antibodies; evolution of other biomarkers and phenotypic characteristics of T lymphocytes.

Atopic dermatitis (AD) is a chronic inflammatory disease of the skin. AD is very frequent, and involves T lymphocytes cells. Measles vaccination, as well as measles vaccine, induces a temporary immunosuppression; furthermore, an improvement of AD has been observed during measles infection.

This trial is aimed at demonstrating that measles vaccine is able to create an immunomodulation and to improve AD symptoms.

Eligibility Criteria:
Inclusion Criteria:

* adults patients of both sexes, with moderate to severe Atopic Dermatitis (SCORAD (Score for Atopic Dermatitis) ≥ 15).

Exclusion Criteria:

* hypersensititvity or contra-indication to a Rouvax® component, Tubertest® component, to egg proteins, immunological deficiency, pregnancy, neomycin
* allergy,
* systemic immnosuppressive treatment in the previous 3 months,
* topic immunosuppressive treatment during the week preceeding the inclusion (gluco-corticoid, or immunosuppressive agent),
* fever or acute disease (the inclusion must be postpone in such cases).
Vitamin D Intervention in Infants

The study is a randomized, controlled, double blinded study evaluating the effect of recommended (400 IU) and 1 200 IU daily vitamin D substitution, given from 2 weeks to 2 years of age, on growth, bone development, neurologic and cognitive development, frequence of infectious diseases, allergic symptoms, and development of immunoregulation assessed at 2 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Infants born at term (37-42 wks, weight appropriate for gestational age) are included in the study

Exclusion Criteria:

* Non Caucasian mother
* Any continuous regular medication of mother
* Treatment at neonatal intensive care unit
* Antibiotic treatment of the infant
* Congenital malformations of the newborn
* Treatment with ventilation support (continuous nasal positive airway pressure) for over 24 hours
* Glucose infusion of the newborn
* Neurological symptoms of the newborn
* Phototherapy for jaundice of the newborn
* Need for nasogastric feeding of the newborn
Adaptive Therapy for Post-Second-Line Advanced Breast Cancer

The primary objective of this study is to explore the efficacy and safety of adaptive therapy in the treatment of post-second-line metastatic breast cancer.

This is a phase II, prospective, single arm clinical trial. The objective of the study is to evaluate the efficacy and safety of adaptive therapy in the treatment of post-second-line advanced breast cancer. The therapy regimen primarily including Gemcitabine, Vinorelbine, or Eribulin, will be selected by the investigator based on current guidelines, available treatments, and an assessment of the patient's clinical status, preferences, and financial situation. This study plans to recruit 10 subjects.

Eligibility Criteria:
Inclusion Criteria:

* Understands and voluntarily signs the informed consent form.
* Minimum life expectancy 16 weeks.
* Histologically or cytologically confirmed advanced invasive breast cancer.
* Histological type: human epidermal growth factor receptor 2 (HER2) negative.
* Prior failure of at least first-line treatment for metastatic disease.
* At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
* Adequate organ function including bone marrow, renal function, hepatic function, and cardiac reserve.
* Premenopausal women must use medically acceptable contraception during the study.
* Compliance with the study protocol.

Exclusion Criteria:

* Pregnant or breast feeding.
* Uncontrolled medical problems.
* Evidence of active acute or chronic infection.
* Hepatic, renal, cardiac, or bone marrow dysfunction.
* Concurrent malignancy or history of other malignancy within the last five years.
* Patients were unable or unwilling to comply with program requirements.
* Concurrent use of any other anti-cancer therapy.
Investigation of Inflammation in Alzheimer's Disease and Related Dementias (ADRD) Using [11C]-CS1P1

This study involves a brain positron emission tomography (PET) scan with a new, investigational radioactive tracer called \[11C\]-CS1P1 to identify inflammation in the brain by testing with healthy older adults and with cognitively impaired older adults.

The primary objective of this IND study is to further evaluate the \[11C\]-CS1P1 for PET imaging of S1P1 expression in healthy older adults and in adults with Alzheimer's disease and Related Dementia (ADRD). Investigators will complete imaging of the brain and neck in older adults with normal cognition and those with clinically diagnosed cognitive impairment from ADRD to characterize \[11C\]-CS1P1 uptake in the brain. Investigators will compare the normal cognition participants to patients with ADRD to collect preliminary data that will subsequently test the hypothesis that \[11C\]-CS1P1 uptake is elevated in patients with ADRD.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, any race;
* Age ≥ 50 years;
* Capable of providing written informed consent OR having a legally authorized representative (LAR) to provide informed consent for volunteering to undergo research procedure;
* Additional inclusion for ADRD group: clinical diagnosis of mild cognitive impairment or early dementia due to ADRD, OR biomarker diagnosis of Alzheimer's disease, with or without symptoms.

Exclusion Criteria:

* Hypersensitivity to \[11C\]-CS1P1 or any of its excipients;
* Contraindications to PET, CT, or MRI (e.g. certain incompatible electronic medical devices, inability to lie still for extended periods) that make it potentially unsafe for the individual to participate;
* Severe claustrophobia;
* Women who are currently pregnant or breast-feeding;
* Currently undergoing radiation therapy;
* Any condition that, in the opinion of the Sponsor-Investigator or designee could increase risk to the participant, limit the participant's ability to tolerate the research procedures or interfere with collection of the data (e.g., renal or liver failure, advanced cancer);
* Participants who in the last 6 months experienced any of the following cardiovascular conditions or findings in the screening electrocardiogram (ECG): clinically significant cardiac arrhythmias including high grade heart block (type 2 or greater), unstable angina, or decompensated heart failure requiring hospitalization or Class III/IV heart failure;
* Moderate to Severe anemia with Hemoglobin \< than 9.9 in both males and females.
* Current or recent (within 12 months prior to screening) participation in research studies involving radioactive agents such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the U.S. Code of Federal Regulations (CFR) Title 21 Section 361.1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=361.1
Intervention Targeting Substance Using Older Adults With HIV

The proposed study uses a randomized controlled experimental design to evaluate the efficacy of a brief intervention using spiritual self schema (3S+) counseling to simultaneously target HIV health outcomes, and substance use among alcohol and/or drug dependent HIV positive older adults (age 50+), relative to an attention control condition. Participants will be randomly assigned to receive either: (1) 12 sessions of 3S+ counseling, adapted for the present study to target both non-injection drug use, drinking, and HIV health; or (2) 12 sessions of education about HIV health and the associated with alcohol and drug use that will serve as an attention-control.


Eligibility Criteria:
Inclusion Criteria:

* HIV+ (provide HIV medication bottle with name on it)
* Age 50 or older (provide picture ID with DOB at baseline)
* Report current alcohol/drug dependence (AUDIT score of 8 or DAST-10 score of 4 on screener; C-DIS at baseline)
* On a prescribed HAART medication regimen and reports sub-optimal adherence (self-report missed at least 3 days in last 30 at 1 pill/day that is 90%)
* Communicate with staff and complete a survey in English or Spanish (English only for the pilot)

Exclusion Criteria:

* Current intravenous drug use (self-report at screener and baseline)
* Currently in a methadone drug treatment program (screener self-report)
* Unstable, serious psychiatric symptoms (SCID-Psych at baseline)
* Currently suicidal/homicidal (SCID-Psych at baseline)
* Gross cognitive impairment (Mini-Mental at baseline)
* Current enrollment in alcohol/drug treatment or HIV study (screener self-report)
Comparison of 18-F Sodium Fluoride Uptake in Culprit Plaques Between Acute Coronary Syndrome and Stable Angina

The purpose of this study is to evaluate the correlations between active calcification and vulnerable plaque.


Eligibility Criteria:
Inclusion Criteria:

* Age more than 20
* Acute coronary syndrome or stable angina

Exclusion Criteria:

* Contraindications to the use of heparin, aspirin, clopidogrel, stainless metal, contrast media
* Acute ST segment elevation myocardial infarction within 12hours, heart failure, cardiac shock
* Any serious medical comorbidity such that the subject's life expectancy is less than 24 months
* Ejection fraction less than 30
* Serum creatinine level of 1.5mg/dl and over
* Vasculitis
* Unwillingness or inability to cooperate or to give informed consent
Melphalan, Lenalidomide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis

RATIONALE: Drugs used in chemotherapy, such as melphalan and dexamethasone, work in different ways to stop the growth of abnormal plasma cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop the abnormal plasma cells from growing. Giving melphalan together with lenalidomide and dexamethasone may be an effective treatment for primary systemic amyloidosis.

PURPOSE: This phase II trial is studying the side effects and how well giving melphalan together with lenalidomide and dexamethasone works in treating patients with primary systemic amyloidosis.

OBJECTIVES:

Primary

* To determine the tolerability and safety of melphalan, lenalidomide, and dexamethasone, in terms of toxicity, in patients with primary systemic amyloidosis.
* To determine the hematologic response rate in patients treated with this regimen.

Secondary

* To assess organ response in patients treated with this regimen.

OUTLINE: Patients receive oral lenalidomide once daily on days 1-21, oral melphalan once daily on days 1-4, and oral dexamethasone once on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 3 months until disease progression and then annually thereafter.

Eligibility Criteria:
Inclusion Criteria:

DISEASE CHARACTERISTICS:

* Diagnosis of primary systemic amyloidosis

PATIENT CHARACTERISTICS:

* Not pregnant
* Negative pregnancy test
* Able to tolerate an anticoagulation regimen (e.g., 325 mg of aspirin per day, therapeutic warfarin, or low molecular weight heparin)

PRIOR CONCURRENT THERAPY:

* Recovered from prior therapy

  * Permanent or stable side effects/changes allowed
* Prior chemotherapy, thalidomide, lenalidomide, or steroids for amyloidosis allowed
* More than 4 weeks since prior and no other concurrent cytotoxic chemotherapy or radiotherapy

Exclusion Criteria:

* No secondary or familial amyloidosis
* No multiple myeloma (≥ 30% plasma cells in bone marrow biopsy or lytic bone lesions)
* No prior cumulative doses of oral melphalan \> 200 mg
* No more than one prior course of high-dose melphalan with stem cell transplant
The Effect of Modified Constraint Induced Movement Therapy on Upper Extremity Function in Stroke Rehabilitation

The purpose of the study is to determine the effect of Modified Constraint-Induced Movement Therapy and trunk restraint contrasted with conventional physical therapy treatment on improving upper extremity function, balance, and quality of life among chronic hemiplegic patients.

* To find out the effectiveness of conventional physical therapy treatment on improving upper extremity function, balance, and quality of life among chronic hemiplegic patients.
* To find out the effectiveness of modified constraint induced movement therapy (mCIMT) and trunk restraint along with conventional physical therapy treatment on improving upper extremity function, balance, and quality of life among chronic hemiplegic patients.
* To find out the effectiveness of modified constraint induced movement therapy (mCIMT) and trunk restraint combined with conventional physical therapy treatment versus conventional physical therapy treatment alone on improving upper extremity function, balance, and quality of life among chronic hemiplegic patients.


Eligibility Criteria:
Inclusion Criteria:

* Right or left-sided chronic hemiplegic patients.
* Onset of stroke More than six months.
* Age between 45 to 65 years of both genders.
* Mini-Mental State Examination - Scored more than 24/30.
* Modified Ashworth Scale for spasticity 1 or 1+.
* Have at least 20° wrist active extension and at least 10° of metacarpophalangeal active extension of the paretic upper extremity.
* Have at least grade 2/5 of muscle power on upper extremity especially in wrist extensors.
* Have normal visual perception.
* With no other neurological disorders.

Exclusion Criteria:

* Unable to follow visual and oral commands.
* Unilateral neglect.
* Severe cognitive, or language deficits.
Clinical Trial of a Supporter-Targeted Intervention to Improve Outcomes in Recent Sexual Assault Survivors

Communication and Recovery Enhancement (CARE) is a 2-session early intervention for survivors of recent sexual assault and their supporters that aims to improve supporters' ability to respond effectively. The goal of this pilot trial is to understand the acceptability and preliminary efficacy of two versions of CARE: a version in which survivors and supporters attend both sessions together (dyadic CARE) and a version in which supporters attend sessions alone (supporter-only CARE). Survivors aged 14+ with elevated posttraumatic stress symptoms will enroll with a supporter of their choosing. Dyads will be randomized to dyadic CARE, supporter-only CARE, or waitlist control, and will complete self-report assessments at baseline, post-session-1, and follow-ups (1, 2, and 3 months post-baseline). Results will be used to inform future changes to CARE and determine whether a fully-powered randomized controlled trial is warranted.


Eligibility Criteria:
Inclusion Criteria (Survivors):

* Age 14+ years
* Can speak/read English or Spanish
* Have access to a Zoom-capable device
* Screened for eligibility within 10 weeks of sexual assault, defined as any unwanted, distressing sexual contact (e.g., unwanted touching, coerced sexual activity, rape)
* Able to attend first study session within 2 weeks of screening
* Elevated PTSD symptoms at screening as operationalized by a Primary Care PTSD Screen score of 2/5 or above
* Able to identify an eligible supporter
* Have a way to receive survey links and complete surveys privately (i.e., without potential device or account access by the supporter)

Inclusion Criteria (Supporters):

* Age 14+ years
* Can speak/read English or Spanish
* Have access to a Zoom-capable device
* Able to attend first study session within 2 weeks of survivor's screening
* Are in contact with the survivor at least once a week
* In the opinion of the survivor, are able to make an independent decision about whether or not to participate in the study
* Have a way to receive survey links and complete surveys privately (i.e., without potential device or account access by the survivor)

Exclusion Criteria (Survivors):

* Active psychosis
* Active suicidal intent

Exclusion Criteria (Supporters):

* Perpetrated the sexual assault
* Engaged in severe past-year violence or abuse (as defined by the survivor) against the survivor
* The survivor has not told the supporter about the sexual assault at the time of screening and was not already planning to tell the supporter
* In the opinion of the survivor, relational conflict exists between the survivor and supporter that potentially could be exacerbated by program participation
Safety and Efficacy Study of Bimatoprost, Latanoprost, and Travoprost in Patients With Elevated Intraocular Pressure (IOP) and Open-angle Glaucoma (OAG)

To investigate the effectiveness of the newer IOP-lowering therapies, as prescribed in normal clinical practice, in larger patient numbers. Patients will be assessed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of Primary Open-Angle Glaucoma or Ocular Hypertension newly diagnosed OR presenting with insufficiently controlled IOP on current medication (in the opinion of the treating physician)
* Patient is having both eyes treated

Exclusion Criteria:

* Contraindications per product labelling will apply.
* Patients with any ophthalmic co-morbidity with an influence on visual field deterioration or optic nerve head damage.
Maintain Respiratory Muscle Function and Reduce Pneumonia Risk in Cancer Patients

This research is intended to begin to explore the impact of inspiratory muscle resistance exercise and/or 1,25(OH)2D3 for improving respiratory muscle strength in cancer patients (subjects).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cancer
* Renal and hepatic function (creatinine \</= 2 x the institutional upper limit of normal; bilirubin \</= 2 x the institutional upper limit of normal)
* No contraindication to receive either of the planned interventions of inspiratory resistance training or 1,25(OH)2D3 in the opinion of the healthcare provider
* No difficulties with swallowing oral medications in the opinion of the enrolling physician

Exclusion Criteria:

* Patient is taking calcium or Vitamin D supplements and is unwilling to stop for 8 weeks
* Severe chronic obstructive pulmonary disease (oxygen dependent or patient self-reports unable to walk one block without difficulty)
* Calcium or phosphorus level above the institutional upper limit of normal
Wavefront-guided vs. Topography-guided LASIK

The study is comparing outcomes of wavefront-guided LASIK to topography-guided LASIK in a randomized contralateral fellow eye study in myopic participants.

The purpose of the study is to compare the results of wavefront-guided LASIK surgery to topography-guided LASIK surgery in participants with nearsightedness with or without astigmatism

Three FDA-approved laser devices are being used for the study.

Two excimer lasers are being used for the study. The excimer laser is used to perform the reshaping of the cornea under a LASIK flap to correct nearsightedness, farsightedness and astigmatism. The two lasers being utilized are the Johnson and Johnson Visx CustomVue excimer laser and the Alcon Allegretto laser in the study. Both have received FDA-approval via a PMA pathway.

One femtosecond laser is being used in the study. The femtosecond laser is used to create the LASIK flap during the first part of the LASIK procedure. The Intralase iFS150 femtosecond laser is being used in the study. The femtosecond laser received FDA- approval via a 510k pathway.

All three lasers are being used according to their approved indications.

Eligibility Criteria:
Inclusion criteria.

* Subjects ages 22 to 59with healthy eyes. Nearsightedness between -1.00 diopters and -9.00 diopters.
* Subjects with less than or equal to 3.00 diopters of astigmatism.

Exclusion criteria.

* Subjects under the age of 22 and over the age of 59
* Subjects with excessively thin corneas.
* Subjects with topographic evidence of keratoconus.
* Subjects with ectactic eye disorders.
* Subjects with autoimmune diseases.
* Subjects who are pregnant or nursing.
* Subjects must have similar levels of nearsightedness in each eye. They cannot be more than 1.5 diopter of difference between eyes.
* Subjects with more than 3.00 diopters of astigmatism
* Subjects must have similar levels of astigmatism in each eye. They cannot have more than 1.00 diopters of difference between eyes.
Correlation Between Parameters and Prognosis of Cervical Single Open-door Surgery

The aim of study was evaluated the relationship between the relevant evaluation indexes of cervical spine open-door surgery, prognosis and complication rate, and provided theoretical basis for personalized surgical program through multi-center retrospective clinical study


Eligibility Criteria:
Inclusion Criteria:

* Symptoms and signs of the patients were typical. MRI showed single or multiple central herniation of C3-C7 intervertebral discs or spinal stenosis at corresponding levels, which confirmed cervical myeloid cervical spondylosis or cervical spinal stenosis.
* Conservative treatment for more than 3 months before surgery was ineffective.
* The patients underwent cervical single open-door surgery.
* Informed consent was obtained from the patient and his family, informed consent was signed, and a complete follow-up was completed after surgery

Exclusion Criteria:

* Cervical spondylotic radiculopathy.
* Cervical kyphosis or instability.
* Cervical spondylosis caused by trauma, tumor, tuberculosis and metabolic diseases.
* Revision surgery or combined anterior-posterior surgery is required.
* The patients had severe neurological diseases affecting the evaluation of postoperative results.
* Psychopath.
* MRI or CT for contraindications.
Open Lung Strategy During Non-Invasive Respiratory Support of Very Preterm Infants in the Delivery Room

The opening and aeration of the lung is critical for a successful transition from fetal to neonatal life. Early nasal CPAP in the delivery room in spontaneously breathing premature babies with a gestational age of 30 weeks or less is a standard treatment approach since it reduces the need for invasive mechanical ventilation and surfactant therapy. In respiratory distress syndrome (RDS) management, providing optimal lung volumes in the very early period from the beginning of delivery room approaches probably augments the expected lung protective effect. Although the benefits of CPAP support are well known, standart CPAP pressures recommended in the guidelines may not meet the needs of individual babies. Maintaining lung patency in the delivery room is the main mechanism of action of CPAP and the requirement may vary individually depending on lung physiology.

In this multicenter randomized controlled study, we aimed to compare the effects of CPAP therapy applied with a personalized open lung strategy (openCPAP), and standard CPAP therapy (standardCPAP) on oxygenation, respiratory support need and surfactant treatment requirement in preterm babies with RDS in the delivery room.


Eligibility Criteria:
Inclusion Criteria:

* Infants born before 30 completed weeks of gestation and received early nCPAP immediately after birth in delivery room

Exclusion Criteria:

* Requirement of surfactant or endotracheal intubation or positive pressure ventilation before the completion of interventions
* Major congenital anomaly
* Transportation to another hospital