cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study of Topical Antiflammin-2 for Psoriasis

This study is a pilot trial designed to evaluate topical antiflammin-2, a phospholipase A2 (PLA2) inhibitor, in the treatment of chronic plaque psoriasis. Antiflammin-2 in an ointment base, or the vehicle alone will each be applied four times per day to a single plaque in a randomized, double-blinded fashion.

This study is a pilot trial designed to evaluate topical antiflammin-2, a phospholipase A2 (PLA2) inhibitor, in the treatment of chronic plaque psoriasis. Antiflammin-2 in an ointment base, or the vehicle alone will each be applied four times per day to a single plaque in a randomized, double-blinded fashion.

Eligibility Criteria:
Patients must be age 18 or older.

Patients male or female must use contraception if of childbearing age. No men and women actively attempting to conceive a child during the time of drug testing. No pregnant or nursing women.

Patients must be otherwise healthy, immunocompetent, ambulatory patients with psoriasis who have more than 5 percent of their body surface area involved with the disease or who have localized disabling psoriasis.

Have failed one prior topical treatment regimen including topical cortiscosteroids, coat tar preparations, or ultraviolet light.

An ambulatory performance status of 0,1,2 (ECOG Scale).

Ability to participate in an out -patient study and to provide informed consent.

Creatinine less than 2.0 mg/100ml. Bilirubin less than or equal to 1.5 mg/100ml; prothrombin time less than or equal to 1.3 times control. WBC greater than 3000/mm(3), granulocytes greater than 1500/mm(3), platelets greater than 100,000/mm(3).

No clinically significant cardiac disease.

No patients with previously documented serious infectious diseases such as pneumocystis pneumonia, mycobacterium avium infection, etc. which would suggest clinically evident immunodeficiency.

No systemic treatment for psoriasis (methotrexate, PUVA, UVB, cyclosporine, etc.) and topical treatments (corticosteroids, tar, anthralin, etc.) during the four weeks prior to study entry, and topical treatment during the two weeks prior to study entry.
PTNS Versus Sham Efficacy in Treatment of BPS

This is a prospective, single center, double-blind, randomized, controlled trial comparing the efficacy of percutaneous tibial nerve stimulation to sham in the treatment of Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC) through 12 weeks of therapy.

This is a pilot study to evaluate the efficacy of the systematic effects of posterior tibial nerve stimulation (PTNS) treatment compared to an inactive sham intervention in female subjects with interstitial cystitis/bladder pain syndrome (IC/BPS) in an intent-to-treat analysis. The primary outcome measure will be the Patient Global Impression of Improvement (PGI-I) a single item questionnaire assessing overall impression of improvement over time at the initial 12 weeks endpoint.

It is hypothesized that subjects randomized to the PTNS arm will demonstrate a greater improvement in both pain and quality of life scores, when compared with subjects who are randomized to the sham arm.

Eligibility Criteria:
Inclusion Criteria:

* Women ≥18 years old with visual analog scale \> 5
* Cessation of all analgesics or other medication for pain for at least 2 weeks prior to the PTNS intervention
* Discontinuation of any other electrical stimulation methods for 3 months prior to PTNS intervention.
* Capable of giving informed consent
* Ambulatory
* Capable and willing to follow all study-relation procedures

Exclusion Criteria:

* Patients pregnant or planning to become pregnant during the study duration
* Botox use in pelvic floor muscles within the last year
* Current urinary or vaginal infections
* Current use of Interstim device
* History of a cardiac pacemaker
* Diagnosis of neuropathy
Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis

This study will evaluate the efficacy and safety of plozasiran in approximately 140 adult participants with severe hypertriglyceridemia (SHTG) and history of at least two prior acute pancreatitis (AP) events not attributed to other etiologies, with at least one occurring within the last 12 months prior to screening. Eligible participants will be randomly assigned in a double-blind manner to either receive plozasiran 25 mg by subcutaneous (SC) injection every three months (Q3M) or matching placebo. Enrolled participants will be counseled to remain on the specified low-fat diet and background medications throughout the study. Following completion of the double-blind treatment period, or if the participant has a positively adjudicated AP event (whichever occurs first), participants will transition to the 12-month Open-Label Extension (OLE) treatment period receiving plozasiran 25 mg by SC injection Q3M.


Eligibility Criteria:
Inclusion Criteria:

* Males, or nonpregnant (who do not plan to become pregnant) nonlactating females
* Established diagnosis of SHTG and prior documented evidence of fasting TG levels of ≥ 880 mg/dL (≥ 10 mmol/L)
* Documented evidence of at least 2 prior AP events not attributed to other etiologies with at least 1 occurring within the last 12 months prior to Screening.
* Fasting low-density lipoprotein cholesterol (LDL-C) ≤ 130 mg/dL (≤ 3.37 mmol/L) at Screening
* Screening hemoglobin A1c (HbA1c) ≤ 9.0%
* Willing to follow diet counseling and maintain a stable low-fat diet
* Must be on standard of care lipid and TG-lowering medications per local guidelines (unless documented as intolerant, or a treatment failure as determined by the Investigator)

Exclusion Criteria:

* AP ≤ 4 weeks prior to Randomization/Day 1
* Body mass index (BMI) \> 45 kg/m\^2
* Any planned bariatric surgery or similar procedures to induce weight lost starting at consent through End of Study (EOS)
* Planned coronary intervention (e.g. stent placement or heart bypass) during the study
* History of arterial revascularization within 16 weeks of Screening
* History of acute coronary syndrome event within 24 weeks of Screening
* Recent atherosclerotic cardiovascular disease (ASCVD) event within 24 weeks of Screening
* Recent unstable or symptomatic cardiac arrhythmia (including any associated medication changes) within 90 days of Screening. Individuals with stable well-controlled atrial arrhythmia will be allowed to participate in the study
* History of pacemaker or automatic implantable cardioverter defibrillators implant within 30 days before Screening
* New York Heart Association Class III-IV heart failure or last known ejection fraction of \< 30%
* Current diagnosis of nephrotic syndrome
* Chronic kidney disease, defined by an estimated glomerular filtration rate (eGFR) \< 20 mL/min/1.73 m\^2
* Liver disease defined as cirrhosis or Child-Pugh Class B and C, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5× Upper Limit of Normal (ULN) at Screening

Note: Additional Inclusion/Exclusion Criteria may apply per protocol
Treatment of CD19 Chimeric Antigen Receptor T Cells for Pediatric Patients With CD19-positive B-cell Acute Lymphoblastic Leukemia Who Are Indicated for Hematopoietic Stem Cell Transplantation

This is a phase 2 clinical trial targeting pediatric and adolescent patients diagnosed with CD19-positive B-ALL, considered very high-risk group. The study aims to administer CD19 CAR-T therapy as an alternative to hematopoietic stem cell transplantation in patients eligible for such transplantation. The trial includes patients aged 25 or younger.


Eligibility Criteria:
Inclusion Criteria:

* Subject eligibility criteria include individuals who are under the age of 25 at the time of SNUH-CD19-CAR-T administration. Confirmation of B-cell acute lymphoblastic leukemia diagnosed at the initial assessment by a treating physician for the first diagnosis is required. Immunophenotypic analysis of CD19 expression on leukemia cells must be confirmed through immune profiling at the time of the initial diagnosis of B-cell acute lymphoblastic leukemia. In patients experiencing hematologic relapse of B-cell acute lymphoblastic leukemia, CD19 expression should also be confirmed at the time of relapse confirmation.

Patients must achieve hematologic complete remission defined as less than 5% blasts in the bone marrow after the first-line or second-line chemotherapy (first salvage therapy). Eligible patients for hematopoietic stem cell transplantation, defined by indications for transplantation, include those meeting at least one of the following criteria:

1. Philadelphia chromosome-positive due to t(9;22)(q34;q11) translocation.
2. Hypodiploidy defined by fewer than 44 chromosomes.
3. E2A-HLF gene fusion due to t(17;19) translocation.
4. Detection of minimal residual disease (MRD) positive at 0.01% or higher by next-generation sequencing confirmed after consolidation therapy and maintenance therapy.
5. Failure of the first-line therapy.
6. Cases not meeting any of the above criteria but deemed eligible for hematopoietic stem cell transplantation based on the investigator's judgment.

Exclusion Criteria:

* Patients who have undergone hematopoietic stem cell transplantation.
* Individuals for whom an adequate or sufficient leukapheresis product suitable for the production of SNUH-CD19-CAR-T cannot be obtained or is unavailable.
* Those known to be infected with the human immunodeficiency virus (HIV).
* Presence of uncontrolled active infections, determined by the investigator's assessment. If appropriate treatment has been administered for the infection, and there are no signs of progression at the time of enrollment, it is considered controlled. Persistent fever without other symptoms is not interpreted as progressive infection.
* Women who are pregnant or breastfeeding.
* Individuals deemed clinically inappropriate for participation in the clinical trial based on the investigator's clinical judgment.
Impact of the Type of Interface in Neuromuscular Patients Treated With Nocturnal Noninvasive Ventilation

Nocturnal Non Invasive Ventilation (NIV) is the reference treatment for chronic alveolar hypoventilation in patients with neuro-muscular diseases. NIV can be provided by using different types of interfaces: Nasal masks are the most frequent type of interface used at home but oronasal masks are used by at least 25% of neuro-muscular patients mainly because of persistent unintentional mouth leaks. However, oronasal mask may cause persistent upper airway obstructive respiratory events because of the mechanical constraint on the chin induced by the traction of the straps that may push the mandible posteriorly during sleep.

No randomized study has specifically addressed the question of the impact of type of interface in patients with neuromuscular diseases treated by nocturnal NIV.

The investigators hypothesize that:

1. the application of oronasal mask may jeopardize the pharyngeal patency in patients already proned to upper airway obstruction;
2. the use of a nasal mask may improve upper airway stability and NIV efficacy while reducing side effects.

Authors objective will be to compare the impact of nasal mask versus oronasal mask on NIV efficacy and side-effects. Eligible patients are those with nocturnal NIV and neuromuscular disease.

After a scheduled hospital visit, patients willing to participate will undergo in random order 2 unattended nocturnal polygraphies under NIV at home: one polygraphy with nasal mask; one with an oronasal mask. Each polygraphy ans side effects assessment will be performed after one week of familiarization with each mask.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years old)
* Affected by slowly progressive neuro-muscular diseases (Becker muscular dystrophy, facio-scapulo-humeral dystrophy, limb-girdle dystrophy, myotonic dystrophy...) or relatively rapid progression (Duchenne muscular dystrophy).
* Treated with nocturnal non-invasive ventilation (\<15 hours/day)
* In stable state (no cardiorespiratory or ear-nose-throat event for at least 1 month before inclusion)

Exclusion Criteria:

* Rapidly progressive neuro-muscular diseases (such as ALS)
* Severe nasal obstruction, maxillofacial deformities or previous upper airway surgery preventing the usage of one type of mask (nasal or oronasal), or, at the discretion of investigator, any other contraindication for using the other type of mask
* NIV Daily use \>15h/day
* Unwillingness or inability to provide consent to participation
* Curatorship
* Subject in exclusion period of another study
* Vulnerable person or legally protected adult.
DERCOS DS DANDRUFF TREATMENT OBSERVATIONAL STUDY 2022

The aim of this study is to evaluate the satisfaction / tolerance / cosmeticity of Dercos DS


Eligibility Criteria:
Inclusion Criteria:

* Patients with dandruff or seborrheic dermatitis
* All hair types
* All ethnicities (Asian, Caucasian, Afro-American, African, Hispanic)
* Including patients with specific occlusion habits (for instance veil use at least 8 hours per day, hat use)
* Patients willing to provide written informed consent

Exclusion Criteria:

* Under 12 years old
* Pregnancy, breast feeding, childbearing potential without adequate contraception, or irregular menstrual cycles.
* History of allergy, anaphylaxis or hypersensitivity to any of the ingredients of Shampoo any of the ingredients of DERCOS ANTI-DANDRUFF normal to oily hair shampoo
* History of allergic contact dermatitis secondary to shampoo, conditioner, mask, and/or leave-in.
* Has any clinical manifestations in the treatment(s) or other disorders that, in the opinion of the investigator, may affect the evaluations or results of the study products.- Inability to stay the study period (56 days +-5 days) without performing any hair/scalp procedure, including coloring, straightening and cutting.
* Inability to attend all study visits and follow treatment regimen
Safety, Tolerability and Immunogenicity of Pneumovax 23 in Healthy Adults in India (V110-011)

To describe the safety, tolerability and immunogenicity of pneumovax 23 (V110) in healthy adults in India.

This was an open-label non-randomized study to assess the safety and immunogenicity of PNEUMOVAXTM 23 in healthy adults in India. The participants enrolled in this study were healthy Indian adults, 50 years of age or older, with no prior history of having received a pneumococcal vaccination (14-valent or 23-valent) and no prior history of Pneumococcal disease. All participants enrolled in the study received one 0.5 mL dose of PNEUMOVAXTM 23 by intramuscular (deltoid) injection on Day 1. Serum samples were obtained prior to vaccination on Day 1 and on Day 28 (+/-7 days) postvaccination. The duration of participation for each participant was approximately one month, with the study completion at the Day 28 postvaccination bleed and return of the Vaccination Report Card (VRC). Enrollment was completed within approximately 2 months. The last postvaccination blood sample was collected within 3 months of study initiation.

Eligibility Criteria:
Inclusion Criteria:

* Healthy indian adults of 50 years of age
* In good health; any underlying chronic illness must be documented to be in stable condition
* Signed and dated informed consent prior to receipt of the study vaccine

Exclusion Criteria:

* Functional or anatomic asplenia
* History of auto immune disease
* Hypersensitivity to any of the components of the study vaccine,including phenol
* Known or suspected immune dysfunction, including persons with congenital immunodeficiency
* Prior vaccination with any pneumococcal vaccine
A Study in North Macedonia Investigating Retrospective Data of Glucagon-like Peptide-1 (GLP-1) Participants With Type 2 Diabetes (T2D) in Real World Environment (RWE) Setting (MIRAGE)

The purpose of this study is to investigate glycaemic control and other clinical parameters in glucagon like peptide -1 (GLP-1) naive adult participants with type 2 diabetes (T2D) who initiated once weekly (OW) semaglutide in local clinical practice in North Macedonia. The participants were treated according to current clinical practice, applicable local labels, and standard of care as per physicians' discretion. The total duration of the study is planned to be approximately 30 weeks which is the period from OW semaglutide initiation to end of follow up.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age above or equal to 18 years at the time of once weekly (OW) semaglutide initiation.
* The decision to initiate treatment with commercially available OW semaglutide has been made by the participant and the treating physician before and independently from the decision to include the participant in this study.
* Adult participants with type 2 diabetes (T2D) initiated with OW semaglutide at least 30 +- 4 weeks prior to data collection.
* Participants should have baseline glycated haemoglobin (HbA1c) measurement and at least one HbA1c measurement after baseline. For baseline HbA1c measurement, the most recent value less than 12 weeks prior to OW semaglutide initiation will be used.

Exclusion Criteria:

* Previous participation in this study.
* Prior use of GLP-1 within last one year.
* Participants with type-1 diabetes and gestational diabetes.
SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study

The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the absence of antihypertensive medications.


Eligibility Criteria:
Inclusion Criteria:

* Individual has office systolic blood pressure (SBP) ≥ 150 mmHg and \<180 mmHg and a diastolic blood pressure (DBP) ≥ 90 mmHg after being off medications.
* Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP ≥ 140 mmHg and \< 170 mmHg.
* Individual is willing to discontinue current antihypertensive medications.

Exclusion Criteria:

* Individual lacks appropriate renal artery anatomy.
* Individual has estimated glomerular filtration rate (eGFR) of \<45.
* Individual has type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus.
* Individual has one or more episodes of orthostatic hypotension.
* Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
* Individual has primary pulmonary hypertension.
* Individual is pregnant, nursing or planning to become pregnant.
* Individual has frequent intermittent or chronic pain that results in treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for two or more days per week over the month prior to enrollment.
* Individual has stable or unstable angina within 3 months of enrollment, myocardial infarction within 3 months of enrollment; heart failure, cerebrovascular accident or transient ischemic attack, or atrial fibrillation at any time.
* Individual works night shifts.
Hand Eczema in the Health Care Sector

This project aims to investigate the prevalence of bacterial colonization and associated factors in health care workers with hand eczema with focus on Staphylococcus aureus.

Two groups will be examined in this study: health care workers with HE and matched controls invited through a questionnaire study which will be sent to approximately 4000 health care workers in Capital Region. Samples from health care workers with and without hand eczema will be collected after obtaining their written informed consent. Collection of samples: Swabs will be rubbed on the skin for 30 seconds on lesional and non-lesional skin on the dominating hand and from the nostrils. The swabs will immediately be stored in -80 C° (research biobank) for subsequent analysis at Statens Serum Institute.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of hand eczema (for group with hand eczema)

Exclusion Criteria:

* Other skin diseases (in both groups)
An Individual-specific Synchrony Signature

This study aims to establish synchrony as an individual-specific mechanism of therapeutic change and offers novel insights into the mechanisms of curative interpersonal processes. The study identifies individual-specific trait-like synchrony signature and investigates the associations between synchrony signature, the individual's trait-like characteristics, and mental health, among participants diagnosed with Major Depressive Disorder. The study further investigates how deterministic the trait-like synchrony signature is by identifying for whom, how, and when changes are anticipated. Additionally, it examines whether synchrony signature transfers to relationships with the therapist, whether and how it changes throughout treatment, and whether such potential changes are associated with improvements in mental health. Synchrony is recognized as a key driver of collaborative, affiliative, and curative relationships. While its potential role in improving mental health through interpersonal relationships has sparked growing interest, particularly in psychotherapy, the field is at a crossroads, with mixed findings challenging the widespread theoretical assumption that "more synchrony is better." This study introduces a personalized framework that emphasizes individual-specific synchrony signatures, shifting from generalized assumptions to tailored understanding and interventions. The study explores how synchrony can transform relationships into curative ones by leveraging individual-tailored changes in synchrony signatures in psychotherapy. The potential impact is vast. Tailoring synchrony to individual-specific signatures represents a paradigm shift from a one-size-fits-all approach to personalized interventions. This personalized framework could revolutionize mental health care by facilitating the development of targeted strategies that enhance treatment outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Current major depressive disorder based on the Diagnostic and Statistical Manual of Mental Disorders-5, and scores above 14 on the 17-item Hamilton rating scale for depression at two consecutive assessments, one week apart.
* For participants using psychiatric medication, the dosage must be stable for at least three months before the beginning of the study, and they will be asked to maintain stable dosage during the treatment
* Age between 18 and 65 years
* Hebrew language proficiency
* Provision of written informed consent.

Exclusion Criteria:

* Current risk of suicide or self-harm
* Current substance abuse disorders
* Current or past schizophrenia or psychosis, bipolar disorder, or severe eating disorder requiring medical monitoring
* History of organic mental disease
* Currently in psychotherapy
Effects of a Resistance Training Period on Blood Pressure of Hypertensive Elderlies: Influence of the Polymorphism of the Angiotensin Converting Enzyme

The study aimed to evaluate the chronic effects of resistance training on blood pressure and biochemical exams in hypertensive elderlies and the influence of the polymorphism of the angiotensin converting enzyme in these response.

To investigate the chronic effects of resistance training on blood pressure and biochemical exams in elderly, 135 hypertensive elderlies were divided into 2 groups: trained and control. The trained group was submitted to a resistance training period. Before the 16 weeks ACE gene was genotyped (PCR). Before and after 16 weeks, blood pressure (ambulatory), HDL-cholesterol, Total cholesterol, Glycemia, Triacylglycerol (colorimetric assay) and plasminogen activator inhibition (PAI-1), intercellular adhesion molecule (ICAM-1), vascular endothelial cell adhesion molecule (VCAM-1), Adiponectin, tumor necrosis factor alpha (TNF-alpha), C Reactive Protein, Angiotensin II, Angiotensin Converting Enzyme, Angiotensin 1-7, (ELISA assay) were measured.

Eligibility Criteria:
Inclusion Criteria:

* Hypertensives
* Age 60 to 85 years
* Nonactive

Exclusion Criteria:

* Orthopedic problems or other problem that prevented the exercises
* Change in drug treatment during protocol
* Absence in more than 25% of the exercise sessions