cyrilzakka/clinical-trials huggingface dataset:
The Use of Onexton in Moderate Acne Vulgaris for Patients With Skin of Color

This is a single-center, open label pilot study. The study is comprised of 5 study visits; Screening, Baseline, and Weeks 4, 8, and 16. All subjects will receive Onexton at Baseline and be instructed to apply the gel once daily to the face. The investigators will evaluate Investigator Global Assessment of acne (IGA), total lesion count, inflammatory lesion count, non-inflammatory lesion count, Investigator Global Assessment of Post-Inflammatory Hyperpigmentation and distribution of Post-Inflammatory Hyperpigmentation, adverse events and concomitant medications.


Eligibility Criteria:
Inclusion Criteria:

i. Outpatient, subjects of skin of color, age 12 or older. Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline and practice a reliable method of contraception throughout the study;

A female is considered of childbearing potential unless she is:

* postmenopausal for at least 12 months prior to study drug administration
* without a uterus and/or both ovaries; or
* has been surgically sterile for at least 6 months prior to study drug administration

Reliable methods of contraception are:

* intrauterine device in use ≥ 90 days prior to study drug administration;
* barrier methods plus spermicide in use at least 14 days prior to study drug administration; or
* vasectomized partner

\[Exception: Female subjects of childbearing potential who are not sexually active will not be required to practice a reliable method of contraception. These subjects may be enrolled at the Investigator's discretion if they are counseled to remain sexually inactive during the study and understand the possible risks in getting pregnant during the study.\]

ii. Facial acne vulgaris in patients with skin of color (Fitzpatrick Type V \& VI Supplement VI) characterized by the following:

* IGA Score for acne vulgaris 3
* IGA Score for PIH 3

iii. Able to understand and comply with the requirements of the study and sign Informed Consent /HIPAA Authorization forms

Exclusion Criteria:

i. Female subjects who are pregnant (positive urine pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control

ii. Allergy/sensitivity to any component of the test treatment

iii. IGA score for acne of 2 (mild) or 4 (severe)

iv. IGA score for Post Inflammatory Hyperpigmentation of 2 (mild) or 4 (severe)

v. Subjects who have not complied with the proper wash-out periods for prohibited medications (Supplement I).

vi. Medical condition that, in the opinion of the Investigator, contraindicates the subject's participation in the clinical study

vii. Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris

viii. Evidence of recent alcohol or drug abuse

ix. History of poor cooperation, non-compliance with medical treatment, or unreliability

x. Exposure to an investigational study drug within 30 days of the Baseline Visit
Comparison of Four Different Recruitment Maneuvers in Patients After Coronary Surgery

The risk of respiratory failure after cardiac surgery is high, and it may result in many complications. The maneuver of alveolar recruitment may improve the oxygen transport in the human organism. The investigators compare three different types of alveolar recruitment in patient after cardiac surgery, to reveal which one is better.

The study compares three different approaches to alveolar recruitment maneuvers in the immediate postoperative period after off-pump coronary bypass grafting.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75
* Off-pump coronary artery bypass grafting
* Possibility to discontinue respiratory support in the first day after intervention

Exclusion Criteria:

* Signs of ARDS
* COPD in decompensation phase
* Requirement for inotropic support(epinephrine \>0,1 mcg/kg/hr)
* Bronchiectases
* Pregnancy
* Morbid obesity
* Aortic aneurism
* AMI in previous month
Statin in Hip Fracture

Statins (or HMG-CoA reductase inhibitors) have largely proven their efficacy in the primary and secondary prevention of cardiovascular events. Many clinical and experimental studies support also a potential beneficial effect of statin therapy on venous thromboembolism (VTE). Patients with hip fracture are at high risk of VTE and cardiovascular events.

The aim of this study is to evaluate the efficacy and the tolerance of a statin (rosuvastatin) in hip fracture surgery on the occurrence of venous and atherothrombotic events and the global mortality at six months.

Subjects aged 60 years or over who are scheduled to undergo surgery for fracture of the upper portion of the femur (hip fracture) are eligible to participate to this multicentre, randomized, double-blind placebo controlled trial. They will receive either rosuvastatin (5 or 20 mg) or placebo for 6 months. The primary efficacy outcome is the incidence of an adjudicated composite of non fatal VTE, acute coronary syndrome, non fatal stroke, other acute ischemic arterial event, or all-cause death.

Assuming a endpoint frequency of 20% in the control group, we calculated that 1200 patients will be required for the study to have 80% power to detect a 30% reduction in the relative risk with rosuvastatin (with a two-sided alpha level of 5%).

The investigators assumed that rosuvastatin could have a positive benefit-risk ratio in patients undergoing orthopaedic surgery for hip fracture, by reducing vascular events and global mortality at six months.


Eligibility Criteria:
Inclusion Criteria:

* 60 years old or older.
* fracture of the femoral neck or of the trochanteric mass
* undergoing surgery within 5 days for this fracture
* Signed written informed consent

Exclusion Criteria:

* contraindication to rosuvastatin:
* active liver disease including unexplained and prolonged elevations of serum transaminases and any increase of serum transaminases beyond 3 times the upper limit of normal
* severe renal impairment (creatinine clearance calculated by the formula MDRD \<30 ml / min)
* myopathy
* use of cyclosporine
* statin therapy ongoing at the admission for fracture
* curative anticoagulant therapy ongoing at the admission and expected to be maintained after the intervention
* Patients considered by the investigator to be unable to participate to the study
* Refuse to participate
Digital Assessment of a Full Digital Implant-Prosthetic Workflow for a Prefabricated Single Implant-Supported Restoration

The aim of the present study was to evaluate the accuracy of a prefabricated digitally planned provisional restoration on a single- implant placed with a fully guided surgical protocol.

Fifteen dental implants were placed in partially edentulous patients with single bounded lower posterior edentulous area selected from those admitted to the Prosthodontics Department, Faculty of Dentistry, Alexandria University. A full digital implant-prosthetic protocol was followed and a quantitative evaluation of the accuracy of the protocol was performed using computer software and superimposition of the planned and post-operative images was done.

Eligibility Criteria:
Inclusion Criteria:

* Patients missing lower first molar unilaterally or bilaterally.
* Presence of full or nearly full complement of opposing natural teeth.

Exclusion Criteria:

* If teeth adjacent to the planned implant site showed infections, endodontic or periodontal problems.
* Patients with a debilitating systemic disease, bone diseases, radiotherapy or chemotherapy.
Evaluating the Use of Patient-Reported Outcome Measures for Improving the Inter-Rater Reliability of Common Terminology Criteria for Adverse Event Ratings

This open randomized trial investigates, if clinicians complete CTCAE ratings differently when receiving patients' patient-reported outcome (PRO) data prior to their CTCAE completion. The primary objective is to demonstrate superior inter-rater reliability of CTCAE ratings from physicians relying on EORTC PRO data as additional data source over traditional CTCAE ratings not including PRO information.

In oncology, detection and tracking of adverse events (AEs) are a top priority in both clinical trials and routine care. The classification of AEs mostly relies on the Common Toxicity Terminology for Adverse Events (CTCAE) developed by the US-American National Institutes of Health and the National Cancer Institute.

It is known, however, that the assessment of AEs can greatly vary depending on whether they are assessed by patients or by clinicians.

Procedure: The patients (any oncological diagnosis, day clinic or inpatient for treatment with chemotherapy or immunotherapy; open 1:1 randomized) fill out an EORTC quality of life questionnaire electronically (C30 + further questions). These PRO data are immediately available for the clinicians. Independently of each other, two different clinicians conduct a medical consultation with the patient and electronically a CTCAE rating. For the intervention Group, clinicians see the PRO values directly next to the input options for the CTCAE rating. For the control Group, clinicians see the input options for the CTCAE rating. The similarity of the assessments is checked using intra-class correlation.

The combined use of PROs and CTCAE data makes particular sense for AEs/aspects that are directly experienced by the patient (fatigue, pain, cognitive problems, emotional functioning, ...) and can only be adequately recorded by the clinician through communication with the patient.

Eligibility Criteria:
Inclusion Criteria:

* any Cancer diagnosis
* current treatment with chemotherapy or immunotherapy
* symptom burden equal or greater score 3 of the screening question "On a scale of 0 to 10, to what degree did you experience physical or emotional symptoms/problems during the last week?"
* ability to understand the questions linguistically and cognitively
* written informed consent

Exclusion Criterion:

* psychiatric diagnosis or mental health problems
Kosmos Trio and Ejection Fraction Pivotal Study

This is a single-group, observational study which will involve obtaining two echo scans of recruited patients. All recruited patients will undergo echo scans by both novice users (nurses) and experts (echo sonographers). Image quality between novices and experts as well as the ability to calculate LVEF from novice and expert scans and the quality of the LVEF calculated via KOSMOS-EF compared to LVEF calculations by expert cardiologists will occur in post-hoc Echo image analysis


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-89 years of age
* Have capacity to provide written consent either themselves or via healthcare proxy as determined by subjects' clinical care teams
* Have an anticipated timeline in the EDOU long enough to allow for completion of study procedures without causing delay to subjects' usual clinical care

Exclusion Criteria:

* Heart rate \> 110 beats per minute at the time of recruitment
* Pregnant women
* Prior chest surgery
* Chest wall deformities or injuries (i.e. wounds, infections, etc)
* Limited mobility precluding them from turning in bed independently
* Speak a primary language other than English or Spanish
* Vulnerable populations including: patients being evaluated for psychiatric crises, incarcerated individuals
* Unwilling or unable to consent to study procedures
Study of Lumasiran in Healthy Adults and Patients With Primary Hyperoxaluria Type 1

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single-ascending doses (SAD) and multiple-ascending doses (MAD) of lumasiran in healthy adult volunteers and subjects with primary hyperoxaluria type 1 (PH1). In Part A, single ascending dose (SAD) part, healthy adults were dosed with lumasiran or placebo once. In Part B, multiple ascending doses (MAD) part, patients with primary hyperoxaluria type 1 (PH1) were dosed with lumasiran or placebo. All patients that initially received placebo received lumasiran after completing placebo dosing.


Eligibility Criteria:
Inclusion Criteria for Parts A and B:

* Women of child bearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception.
* Willing to provide written informed consent and to comply with study requirements.

Additional Inclusion Criteria for Part B:

* Confirmation of PH1 disease
* Meet 24 hour urine oxalate excretion requirements
* Estimated glomerular filtration rate (GFR) of \>45 mL/min/1.73m\^2
* If taking Vitamin B6 (pyridoxine), must have been on stable regimen for at least 90 days

Exclusion Criteria for Parts A and B:

* Clinically significant health concerns (with the exception of PH1 for patients in Part B)
* Clinically significant electrocardiogram (ECG) abnormalities
* Abnormal for aspartate aminotransferase (AST)/alanine aminotransferase (ALT) and any other clinical safety laboratory result considered clinically significant
* Received an investigational agent within 3 months before the first dose of study drug or are in follow-up of another clinical study
* Known history of allergic reaction to an oligonucleotide or N-acetylgalactosamine (GalNAc)
* History of intolerance to subcutaneous injection
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AJM347 in Healthy Male Caucasian and Japanese Subjects in the Fasted and Fed State

This study will be conducted to determine the safety and tolerability of single and multiple oral ascending doses of AJM347 in healthy male participants, and to assess the pharmacodynamic response following single and multiple oral ascending doses of AJM347 in the same population. This study will also aim to determine the single and multiple oral ascending dose pharmacokinetics of AJM347 and its metabolite in healthy male participants, and to determine the effect of food on the single and multiple oral dose pharmacokinetics of AJM347 and its metabolite in the same population.


Eligibility Criteria:
Inclusion Criteria:

Main Inclusion Criteria for all participants:

* Participants will be male
* Participants will be in good health

Main Inclusion Criteria for Japanese participants:

* Be ≥20 to ≤45 years of age
* Have body mass index (BMI) ≥18.5 to ≤25.0 kilograms per meters squared (kg/m\^2)
* Be Japanese

Main Inclusion Criteria for Caucasian participants:

* Be ≥18 to ≤45 years of age
* Have a BMI ≥18.5 to ≤30.0 kg/m\^2
* Be Caucasian

Exclusion Criteria:

Main Exclusion Criteria for all participants:

Participants will be excluded from the study if they satisfy any of the following criteria at the Screening visit, unless otherwise stated.

* Participants who have donated or lost ≥200 milliliters (mL) blood within 1 month or ≥400 mL within 3 months prior to Check-in
* Participants who have an abnormality in heart rate, blood pressure, temperature, or respiration rate at Screening
* Participants who have:

  * a positive urine drugs of abuse screen;
  * a positive alcohol breath test
* Participants who have an abnormality in the 12-lead electrocardiogram (ECG) at Screening
* Participants who are still participating in another clinical study (eg, attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months prior to first dose administration
* Participants who have a significant history of drug allergy, as determined by the Investigator
* Participants who have any clinically significant abnormal physical examination finding
* Participants who:

  * are carriers of the hepatitis B surface antigen (HBsAg);
  * are carriers of the hepatitis C antibody;
  * have a positive result for the test for human immunodeficiency virus (HIV) antibodies
* Participants who, in the opinion of the Investigator, should not participate in this study
Muscle Energy Technique and Facet Joint Mobilization in Chronic Neck Pain.

The purpose of the study is to compare the muscle energy technique, facet joint mobilization and conventional physical therapy in individuals with chronic neck pain on cervical lordosis, cervical range of motions, numeric pain rating scale and NDI. A randomized control trial was conducted at physiotherapy department of HIT hospital, Taxila Cantt. The sample size was 105 calculated through open-epi tool. The participants were divided into three interventional groups, experimental group (1), experimental group (2), and control group (3) each having 35 participants. The study duration was six months. Sampling technique applied was Purposive sampling for recruitment and group randomization using sealed envelope method. Only 35 to 50 years participants with 4-8 pain intensity on NPRS in cervical region were included in the study. Goniometer, Posterior tangent method on lateral radiographs for cervical curve and Self structured Questionnaire. Data was collected at baseline then 2 and 4 weeks after the application of interventions. Data analyzed through SPSS version 21.


Eligibility Criteria:
Inclusion Criteria:

* Chronic patients (more than 12 weeks)
* Male and female patients
* Patients having recurrence of neck pain at least once in the last month.
* Patients from the age group of 35-50 years.
* Patients having mechanical neck pain ranging from 4-8 on Numeric Pain Rating Scale (NPRS).
* Cervical straightening on X-rays.
* Limited \&painful cervical Rang of motion (ROMs)

Exclusion Criteria:

* Any recent history of trauma, active inflammation, Tumor, vertebra-basilar insufficiency and cervical myelopathy \& radiculopathy.
* No history of serious underlying pathology, nerve root compromise, structural changes and deformities, genetic spinal disorders or previous spinal surgery
Artificial Intelligence to Assess the Association Between Facial Characteristics and Coronary Artery Diseases

The purposes of this study are 1) to explore the association between facial characteristics and the increased risk of coronary artery diseases; 2) to evaluate the diagnostic efficacy of appearance factors for coronary artery diseases.

Several age-related appearance factors were described associated with increased risk of coronary artery diseases (CAD). However, several limitations made these facial risk factors hard to be utilized in clinical practice, including 1) low prevalence in CAD patients, 2) lack of specific definition, 3) poor reproducibility in artificial recognition.

Thus, the investigators designed a multi-center, cross-sectional study to explore the association between facial characteristics and CAD and evaluate the diagnostic efficacy of appearance factors for CAD. The investigators will recruit patients undergoing coronary angiography or coronary computer tomography angiography. Patients' baseline information and facial images will be collected. First, the investigators will explore the facial factors associated with CAD by using artificial intelligence technology to compare facial photographs between patients with CAD and without CAD. Secondary, the investigators will evaluate the dose-response relationship between facial characteristics and CAD. Third, the investigators will establish a CAD risk model based on facial factors, and evaluate the diagnostic effect of the model.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing coronary angiography or coronary computer tomography angiography
* Written informed consent

Exclusion Criteria:

* Prior percutaneous coronary intervention (PCI)
* Prior coronary artery bypass graft (CABG)
* Screening coronary artery disease before treating other heart diseases
* Without blood biochemistry outcome
* With artificially facial alteration (i.e. cosmetic surgery, facial trauma or make-up)
* Other situations which make patients fail to be photographed
CLEANer Aspiration for Pulmonary Embolism

To evaluate the safety and efficacy of the Cleaner™ Pro Thrombectomy System for aspiration thrombectomy in patients with acute pulmonary embolism (PE).


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age at the time of consent
* Clinical signs, symptoms, and presentation consistent with acute PE
* Onset of PE symptoms occurred within 14 days of presentation
* Filling defect in at least one main or lobar pulmonary artery evidenced by CTA
* RV dysfunction on CTA or echocardiography defined as RV/LV ratio \>0.9

Exclusion Criteria:

* tPA use within 14 days prior to baseline CTA
* Systolic BP \<90 mmHg for 15 min or the requirement of inotropic support to maintain systolic BP ≥90 mmHg
* Diagnosis of pulmonary hypertension or suspected undiagnosed pulmonary hypertension with peak PA \>70 mmHg by right heart catheterization or elevated main pulmonary artery to aorta ratio (MPA:A)
* History of severe or chronic pulmonary hypertension
* FiO2 requirement \>40% or \>6 LPM to keep oxygen saturations \>90%
* Hematocrit \<28%
* Platelets \<100,000/µL
* Serum creatinine \>1.8 mg/dL
* INR \>3
* aPTT (or PTT) \>50 seconds on no anticoagulation
* History of heparin-induced thrombocytopenia (HIT)
* Recent (within six months) history of stroke, transient ischemic attack (TIA), or intracranial bleeding
* Recent (within one month) history of active bleeding from a major organ
* Absolute contraindication to anticoagulation
* Major trauma such as head trauma, or other active intracranial, or intraspinal disease within 14 days
* Morbidly obese (BMI \>45 kg/m2) patient who by the judgement of the investigator is high risk for bleeding
* Presence of intracardiac lead in the right ventricle or right atrium placed within 6 months
* Cardiovascular or pulmonary surgery within last 7 days
* Cancer which requires active chemotherapy
* Known serious, uncontrolled sensitivity to radiographic agents
* Life expectancy \<90 days, as determined by investigator
* Female who is pregnant
* Intracardiac thrombus
* Patients who present with cardiac arrest and/or are on extracorporeal membrane oxygenation (ECMO) or ECMO required to perform interventional procedure
* Simultaneous participation in another investigational study
* Patients with known coagulation disorders such as antiphospholipid, Protein C, and Protein S
* Presentation of PE with paradoxical emboli which may be diagnosed by concurrent stroke or concurrent arterialization
An Observational Study of Dosage Patterns in Routine Clinical Practice in Patients With Rheumatoid Arthritis (ACT-LIFE)

This observational study will evaluate the dosage patterns, safety and efficacy of RoActemra/Actemra (tocilizumab) in clinical practice in patients with moderate to severe rheumatoid arthritis who have not responded or are intolerant to at least one disease-modifying antirheumatic drug (DMARD) or TNF inhibitor. Data will be collected from each patients for 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Moderate to severe rheumatoid arthritis (RA) of at least 6 months duration
* Non-responder or intolerant to at least one DMARD or TNF inhibitor treatment
* Initiated on treatment with RoActemra according to Summary of Product Characteristics (SPC) indications

Exclusion Criteria:

* History of autoimmune disease or of any joint inflammatory disease other than RA
* Pregnant or lactating women
* Patients who have started RoActemra treatment in a clinical trial or for compassionate use
* Treatment with any investigational drug in the previous 4 weeks (or at least 5 times the half-life of the drug)