cyrilzakka/clinical-trials huggingface dataset:
A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)

The main objective of this study was to evaluate the safety and efficacy of elsubrutinib, upadacitinib (UPA), and ABBV-599 (elsubrutinib/upadacitinib) High Dose and Low Dose combinations vs placebo for the treatment of signs and symptoms of Systemic Lupus Erythematosus (SLE) in participants with moderately to severely active SLE and to define doses for further development.


Eligibility Criteria:
Inclusion Criteria:

* Participant has clinical diagnosis of Systemic Lupus Erythematosus (SLE) at least 24 weeks prior to Screening, meeting at least 4 of the 11 revised Criteria for Classification of SLE according to the 1997 Update of the 1982 American College of Rheumatology (ACR) OR meeting at least 4 of the 2012 SLICC classification criteria, including at least 1 clinical criterion and 1 immunologic criterion.
* At Screening, must have at least one of the following:

  * antinuclear antibody (ANA)+ (titer ≥ 1:80)
  * anti-dsDNA+
  * anti-Smith+
* SLEDAI-2K (SLE Disease Activity Index) ≥ 6 despite background therapy as reported and independently adjudicated (clinical score ≥ 4, excluding lupus headache and/or organic brain syndrome) at Screening:

  * If 4 points of the required entry points are for arthritis, there must also be a minimum of 3 tender and 3 swollen joints.
  * If participant has rash and Principal Investigator (PI) considers it to be attributable to SLE, participant must consent to skin photograph collection for adjudication.
  * Score must be re-confirmed at the Baseline visit.
* Physician's Global Assessment (PhGA) ≥ 1 during screening period.
* Must be on background treatment, stable for 30 days prior to Baseline and throughout the study with antimalarial(s), prednisone (or prednisone equivalent) (≤ 20 mg), azathioprine (≤ 150 mg), mycophenolate (\<2 g), leflunomide (≤ 20 mg), cyclosporine, tacrolimus, and/or methotrexate (MTX) (≤ 20 mg).

  * No combinations of the above with immunomodulators other than prednisone (or equivalents) and antimalarials.

Exclusion Criteria:

- Participant using intravenous (IV) or intramuscular (IM) corticosteroids greater than or equal to a 40 mg prednisone-equivalent bolus within 30 days of planned randomization.
French Observatory on the Management of Cardiogenic Shock in 2016

Cardiogenic shock (CS) is defined as an organ hypoperfusion secondary to low cardiac output. Catches diagnostic management, and therapeutic monitoring of these patients remain highly variable from one center to another and even from one doctor to another within the same team. The management protocols are often not standardized or non-existent.

It appears therefore necessary to make an inventory of the management practices of the CS in France in 2016, prerequisite to a common work of standardization of practices and the creation of specialized networks to support these complex patients.

The Observatory FRENSHOCK proposes to set up a cohort of 500 patients recruited prospectively over a period of 6 months.

Patients will be followed up at 1 month and 1 year Patients should have agreed to participate in the observatory, knowing that participation or refusal to participate will not alter the therapeutic attitude of the physician responsible for the patient. The study of phenotypic characteristics will not change the therapeutic approach of the medical teams.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Cardiogenic shock authenticated by the existence of at least one positive test for each of the following three parts:

(A) Low cardiac output (1 criterion necessary and sufficient):

* Clinic: SBP \<90mmHg and / or need to maintain inotropic or vasopressor to maintain SBP\> 90 mmHg
* Echocardiography: IC \<2.2L / min / m2 and / or LVEF \<30%
* Hemodynamics by Swan Ganz catheterization or right: IC 2.2 l / min / m2 (B) elevation of pulmonary pressure / left surcharge (1 criterion necessary and sufficient):
* Clinical (IVD and abortion);
* Radiological (Surcharge on RT or chest CT);
* Organic (NTproBNP\> 900pg / ml or BNP\> 400pg / ml);
* Echocardiography (E / A\> 2 if LVEF \<45% or E / Ea\> 13 if normal LVEF, or PAPS\> 35mmHg and / or TDE \<150ms and / or Ap-Am\> 30ms and / or E / 2 Vp≥ , 5);
* Right Swan Ganz catheterization or (pulmonary capillary pressures\> 15mmHg and / or mPAP\> 25mmHg)

(C) Organs malperfusion (1 criterion necessary and sufficient):

* Clinic: oliguria \<30ml / kg / h, mottling, consciousness disorders)
* Organic: arterial lactate\> 2 mmol / L, liver failure, kidney failure

Exclusion Criteria:

* Final diagnosis retained other than cardiogenic shock
* Cardiac arrest without spontaneous activity in the hospital management
* Post-cardiotomy cardiogenic shock
* Deprived of liberty patient
* Refusal or lack of consent
Antimicrobial Resistance of Bacteria in Burn Patients

The purpose of this study is to test the resistance of pathogenic bacteria in infected tissues of burn patients to various antimicrobials and enzyme debriders.

Bacteria that is present in infected burn wounds will be isolated and identified. The isolates will be tested for resistance to commercially available antimicrobials.

Eligibility Criteria:
Inclusion Criteria:

* Males and females of any age
* Have open, unhealed wounds(s) that will be cultured per standard of care
* Subject or authorized representative provide informed consent

Exclusion Criteria:

* Informed consent not provided or able to be obtained
Autologous Platelets Rich Plasma (APRP) Treatment Vs Saline Dressing for the Management of Diabetic Foot Ulcer

The aim of this study is to compare between the platelet rich plasma and normal saline dressing in the healing diabetic foot ulcers. It will be a randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic foot wound less than 5cm in greatest diameter Non healing duration greater than 3 months Non infected Palpable distal pulses

Exclusion Criteria:

* Infected wound Wound greater than 5 cm Patient having HBa1c greater than 8% Renal failure Wound with bone exposed or having osteomyelitis
Efficacy of Focused Shockwave Therapy in Patients With CTS

Carpal tunnel syndrome (CTS) is the most common entrapment of upper extremity. Patients with CTS will experience symptoms of pain, numbness of tingling sensation along the median nerve distribution. In more severe case, patients may have difficult manipulating objects that disturb function and patient's quality of life. Extracorporeal Shockwave Therapy (ESWT) is one of physical modalities that uses to treat many musculoskeletal disorders. For CTS, previous evidence showed that ESWT can improve symptoms, function as well as electrophysiologic parameters. However, standardized guidelines as well as the study in patients with moderate to severe CTS has not been established. Thus, the objective of the present study was to evaluate efficacy of ESWT in term of symptoms, function, electrophysiologic parameters, as well as sonography of median nerve in patients with moderate to severe CTS.

* The present study was a single-blinded randomized controlled trial comparing the efficacy of focused ESWT (F-ESWT) to conservative treatment in patients with CTS.
* 24 patients who was diagnosed as CTS based on symptoms of CTS and physical examination. They were randomly allocated into two groups (21 patients per group), mainly F-ESWT plus conservative treatment and conservative treatment only.
* Outcome measures were BCTQ including symptom and function subscales, electrophysiologic parameters, and sonography to evaluate cross-sectional area (CSA) of the median nerve. All measures were recorded at baseline, 3 weeks and 6 weeks of treatment.
* Statistical analysis was performed to determine changes within the same group and compare difference between the two groups.

Eligibility Criteria:
Inclusion Criteria:

1. Participants who were diagnosed as CTS based on the American Academy of neurology
2. Participants who have electrodiagnostic evidence of CTS according to American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) guidelines for diagnosis of CTS. The severity of median nerve compression at wrist was moderate to severe degree.
3. Patients who were not treated by NSAIDs within 2 weeks prior to participating in the study.

Exclusion Criteria: The below exclusion criteria were applied only on the affected hand that were enrolled to the study

1. History of previous carpal tunnel release.
2. Receiving steroid injections for the treatment of CTS
3. History of infection or severe inflammation on the wrist
4. Contraindications for focused ESWT, such as arrhythmias, pacemakers, bleeding disorders, pregnancy, severe osteoporosis, and cancer.
5. Participants who refused or requested withdrawal from the study.
Brief Mental Health First Aid Program (bMHFA) for Parents to Improve Mental Health Literacy in Low-Income Families: A Three-Arm Cluster Randomized Controlled Trial

The goal of this Randomized Controlled Trial study is to test the effectiveness of the brief Mental Health First Aid Program (bMHFA) for parents to improve Mental Health Literacy in Low-Income families. The main questions it aims to answer are:

* Does the brief MHFA program improve mental health literacy among parents in low-income families?
* Does the brief MHFA program improve mental well-being among children in low-income families?

Participants will be randomly assigned to two groups, intervention and control group.

* Intervention group: attend a 2-hour training program on brief MHFA
* Intervention group: complete a set of questionnaire
* Intervention group: Interviews will be conducted at 12-month follow up
* Control: no need to attend any workshop
* Control: complete a set of questionnaire

The traditional MHFA program covers many more mental disorders. Parents in the intervention group will receive a 2-hour workshop delivered by a registered nurse who has a MHFA training certificate from the Mental Health Association of Hong Kong. The first part includes an introduction that defines mental health and identifies mental health crises and symptoms, risk factors, and impacts. The second part of the workshop involves teaching parents the five key ALGEE techniques. The final part of the workshop concerns application of ALGEE in common types of mental disorders, including depression, anxiety, suicidal thoughts and behaviors, and substance abuse. Interviews will be held after 12-month of the intervention.

While the other group (control) will just have to complete a set of questionnaire, same set also need to complete by the intervention group.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 years or above
* able to speak Cantonese and read Chinese
* parenting at least one child aged 8-13 years
* receiving Comprehensive Social Security Assistance or have a household income less than the half of the median
* Children must be able to speak Cantonese and read Chinese

Exclusion Criteria:

* Parents and children with identified cognitive, behavioral, or mental problems will be excluded
Effect of Dietary Phospholipids on Atopic Dermatitis

The aim of the study is to investigate the influence of a milk phospholipid enriched dairy product on subjects with atopic dermatitis determining parameters of the immune status, the plasma lipid profile and the skin texture.

Based on the facts, that on the one hand milk phospholipids are characterized by a high sphingolipid content and on the other hand a disturbed sphingolipid metabolism in the epidermis of patients with atopic dermatitis was verified, a double blinded, controlled, randomized, cross-over study with a daily supplementation of 3 g milk phospholipids to subjects with a mild to moderate atopic dermatitis will be conducted.

Forty patients will be randomized between two groups of each 20 patients. After an individual checkup and a run-in period of 2 weeks, the one group will receive the phospholipid enriched dairy product and the second group will be given a placebo dairy product over two month. A wash out-period of 4 weeks will follow, and the patients will consume the contrary dairy products over two month after a 2-week run-in period again.

Eligibility Criteria:
Inclusion Criteria:

* mild to moderate atopic dermatitis (SCORAD \< 30)
* age: 18 - 60 years

Exclusion Criteria:

* intolerance against milk proteins
* systemic medication with corticosteroids or antihistamines
* immune mediated disease
* atherosclerosis
* hyperlipidaemia
* diabetes mellitus
* angina pectoris
* adipositas
* pregnancy and breast feeding
Investigation of Other Predictive Properties of the ACTA PORT Score

In the scope of this study, it will be determined whether the ACTA-PORT (Association of Cardiothoracic Anesthetists perioperative risk of blood transfusion) scoring system can predict the incidence of events in other organ systems, and the feasibility of conducting multiple assessments using a single simple score will be investigated.

ACTA-PORT (Association of Cardiothoracic Anesthetists perioperative risk of blood transfusion) score is a simple, reliable, and validated tool used to predict the risk of transfusion in patients undergoing heart surgery. In calculating ACTA-PORT score, age, gender, hemoglobin, body surface area, EuroSCORE, creatinine, and type of operation are used.

In this study, it will be determined whether the ACTA-PORT (Association of Cardiothoracic Anesthetists perioperative risk of blood transfusion) scoring system can predict the incidence of events in other organ systems, and the feasibility of conducting multiple assessments using a single simple score will be investigated.

The files of patients undergoing open heart surgery in the cardiovascular surgical operating rooms of Ankara Bilkent City Hospital, along with anesthesia records, transfusion records, and test results identified through the Hospital Information Management System, will be prospectively evaluated. Data will be collected after patients are admitted to the intraoperative and postoperative intensive care unit.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* Patients having open heart surgery
* Patients undergoing surgery by using cardiopulmonary bypass pump

Exclusion Criteria:

* Patients under 18 years old
* Patients diagnosed with kidney disease
Dynamic Decompressive Craniotomy

Prospective observational study on patients undergoing decompressive craniotomy

A prospective study of 20 neurosurgical patients evaluating the dynamic decompressive craniotomy technique using NeuroVention, LLC craniotomy bone flap fixation plates. The plates allow for rigid and semi-rigid bone flap fixation dependent on the implantation technique. A dynamic craniotomy involves bone flap fixation wherein a limited transient outward bone flap movement is allowed by the plates to compensate for an increase in intracranial pressure from brain swelling. The plates also prevent the craniotomy bone flap from sinking inside the skull and compressing on the brain. Cerebral decompression surgery is undertaken for patients with cerebral swelling from malignant strokes, medically intractable intracranial pressure elevation in traumatic brain injuries and brain tumors. The dynamic craniotomy technique eliminates or reduces the need for a cranioplasty surgery with a potentially significant improvement in outcome.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing craniotomy who are at an increased risk for developing post- operative brain swelling or increased intracranial pressure from a malignant stroke
* Patients undergoing craniotomy who are at an increased risk for developing post- operative brain swelling or increased intracranial pressure from traumatic brain injury
* Patients undergoing craniotomy who are at an increased risk for developing post- operative brain swelling or increased intracranial pressure from brain tumors.

Exclusion Criteria:

* Patients with blown pupil (cerebral herniation),
* Massive brain swelling
* Dismal outcome not expected to survive more than 1-2 weeks.
Effect of Low-viscosity Resin Infiltration on Color Change of Enamel White Spot Lesions

this study aimed to assess the effect of the application of the low-viscosity Icon resin infiltrate on the color change of the diagnosed white spot enamel lesions (WSLs) over 3-, 6-, and 12-m follow-up periods. The ICDAS scoring system was used to visually diagnose WSLs in a total of 96 anterior teeth in 49 participants and the teeth were then were evaluated for their color change using a spectrophotometer. According to the manufacturer directions the Icon kit was applied to the WSLs-diagnosed teeth as follows: the WSLs were treated with 15% hydrofluoric acid (Icon-Etch) was applied to the lesions for 120 seconds then it was rinsed for 30 seconds. Next, the etched WSLs were treated with 99% ethanol (Icon-dry) and for 30 seconds. Then the Icon-Resin was applied and light cured for 40 seconds. The change of color was done after 3-, 6- and 12-month . The mean and standard deviation values were statistically analyzed with the repeated measure ANOVA test and the Paired sample t-test.

The early caries may not be noticeable till it appears as rough enamel surface that might has chalky-white or even dark spots of brown color with no cavities formed. These spots reported were referred to as the white spot enamel lesions, that can be visually diagnosed with the ICDAS scoring method (International Caries Detection and Assessment System) that was proposed for the assessment of caries including early enamel lesions that are not yet cavitated and appear after through dryness of the enamel surface.

Remineralization of the white spots enamel lesion presents the first choice treatment option. Still it has some short-outcomes, such as the staining-ability and unreliable esthetic results. It was reported that the Icon resin infiltration to masking the white spot enamel lesion at the minute of its application without a detectable change of color up to a period of six months. The Icon resin infiltration technique depends on its low-viscosity that enables its penetration into enamel surface through capillary action, occluding the micro porosities created in the enamel as a result of the white enamel lesions development. So that, the progression of the lesion would be stopped.

Therefore, this clinical study was conducted to assess the effectiveness of the application of the Icon resin infiltration on the change of the color change of the white spot enamel lesions at follow-up periods of 3-, 6-, and 12-months.

Eligibility Criteria:
Inclusion Criteria:

* Age range 14-18 years,
* Good general health,
* Permanent dentition,
* Sound anterior teeth,
* Non-cavitated white spot enamel lesions.

Exclusion Criteria:

* Presence of current orthodontic treatments,
* Presence of retained teeth,
* Presence of congenital or developmental anomalies in the permanent dentition,
* Students having systematic conditions,
* Smoking,
* Bad oral hygiene,
* General health problems,
* Missed anterior teeth,
* Carious anterior teeth,
* Intrinsic and extrinsic staining
* Presence of anterior restorations.
Open-Label Pharmacokinetics (PK)/Safety Study of Luliconazole Solution, 10% in Distal Subungual Onychomycosis

To determine the safety, tolerability, systemic exposure and pharmacokinetics of luliconazole after repeat daily topical application of Luliconazole Solution, 10% in a maximal use setting in adults with distal subungual onychomycosis of the toenails.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years
* Distal Subungual Onychomycosis(DSO)on both great toenails with \>=50%involvement of at least 1 great toenail
* At least 4 additional toenails with DSO
* Positive KOH and culture
* Normal renal and hepatic function

Exclusion Criteria:

* Subjects with hypersensitivity to imidazole compounds or any other ingredient
* Subjects unwilling to refrain from use of nail cosmetics until end of study
* Subjects with symptomatic tinea pedis
* Subjects with any history of cardiac disease of cardiac rhythm abnormalities
* Female subjects who are pregnant, nursing, or planning a pregnancy
* Subjects who have not undergone the specified washout period(s) for the following or requiring the concurrent use of: topical antifungal within 4 weeks; topical anti-inflammatory, corticosteroids, topical immunomodulators within 2 weeks; systemic corticosteroids within 2 weeks; systemic immunomodulators within 4 weeks.
* Subjects receiving systemic antifungals for treatment of onychomycosis or any systemic antifungal with known activity against dermatophytes within the previous 12 weeks or 5 half-lives of the drug, whichever is longer
* Subjects receiving any other treatment/therapy for the onychomycosis not previously mentioned (e.g., laser treatment) within 4 weeks
* Subjects with a history of significant internal disease or with a life threatening condition within the last 6 months
* Subjects with anatomic abnormalities of the toe(s) and or toenails
* Subject who have donated or lost a large volume of blood (\~500 mL or more, during the previous 6 weeks
* Subjects with a recent history of or currently known to abuse drugs or alcohol
* Subjects currently participating in another investigational medication or device study or have participated in a clinical trial within 30 days or five half-lives of the test medication