cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Brolucizumab vs Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema

The purpose of this study was to evaluate the efficacy and safety of brolucizumab vs. aflibercept in the treatment of patients with visual impairment due to diabetic macular edema (DME).

This study was designed as a Phase III, multi-center, randomized, double-masked, active controlled, parallel group prospective study to evaluate if brolucizumab 6 mg dosed q4w is safe and effective in the treatment of subjects with visual impairment due to diabetic macular edema (DME). Subjects who met all the inclusion and none of the exclusion criteria were randomized in a 2:1 ratio to one of two treatment arms i.e., brolucizumab 6 mg and aflibercept 2 mg. Only one eye was selected as study eye and treated with study medication.

The study included a screening period of up to 2 weeks to assess eligibility, followed by a double-masked treatment period (Day 1 to Week 48). For all subjects, the last study assessment was performed at the Week 52/end of study (EOS) visit. All subjects had study visits q4w through Week 52. The primary analysis was performed at the EOS visit (Week 52).

To ensure masking was maintained, the investigational site had both masked and unmasked staff to perform the masked and unmasked study assessments/procedures accordingly.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent must be obtained prior to participation in the study.
* Patients with type 1 or type 2 diabetes mellitus (DM) and Hemoglobin A1c (HbA1c) ≤ 12% at screening.
* Study eye: Visual impairment due to DME with:

  * Best-corrected visual acuity (BCVA) score between 73 and 23 letters, inclusive, using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters
  * DME involving the center of the macula, with Central Subfield Thickness (CSFT) ≥ 320 µm on Spectral Domain Optical Coherence Tomography (SD-OCT)

Exclusion Criteria:

* High-risk proliferative diabetic retinopathy (PDR) in the study eye
* Concomitant conditions or ocular disorders in the study eye which confound interpretation of study results, compromise visual acuity or require medical or surgical intervention
* Any active intraocular or periocular infection or active intraocular inflammation in the either eye
* Uncontrolled glaucoma in the study eye
* Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA \<20/200
* Use of anti-VEGF therapies, intraocular surgery or laser photocoagulation (macular or panretinal) in the study eye during the 3-month period prior to baseline
* Use of intraocular or periocular corticosteroids in the study eye during the 6-month period prior to baseline, and use of fluocinolone acetonide intravitreal (IVT) implant (Iluvien) at any time prior to baseline
* Prior investigational drugs in either eye, vitreoretinal surgery in the study eye at any time prior to baseline
MxA-Guided Antiviral Treatment in Respiratory Viral Infections

This pilot randomized controlled trial (RCT) will investigate the clinical impact of Myxovirus Resistance Protein A (MxA)-guided antiviral treatment versus standard treatment in patients with respiratory viral infections.

Effective antiviral treatment would shorten the time to symptom resolution, accelerate the cessation of viral shedding, and improve the prognosis of respiratory viral infections. However, the optimal timing for antiviral treatment remains undetermined, and the current lack of objective biomarkers for respiratory viral infections often leads to either prolonged or insufficient antiviral treatment. Thus, there is a need for strategies that incorporate novel diagnostics to guide antiviral treatment and provide more individualized therapy.

Myxovirus resistance protein A (MxA), a novel marker of viral infection, may hold potential in guiding antiviral therapy. In this pilot randomized controlled clinical study, we aim to evaluate whether MxA-guided antiviral treatment, as compared to standard care, can reduce the recurrence rate of respiratory viral infections and improve clinical outcomes

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* With a primary diagnosis of influenza or COVID-19 infection, diagnosed by a rapid antigen test or RT-PCR
* Duration of infection ≤14 days for non-severe patients and \< 28 days for patients with severe infections
* Currently receiving or planned to receive antiviral treatment, with the attending physician yet to decide on the discontinuation of the antiviral treatment

Exclusion Criteria:

* Current endotracheal intubation and mechanical ventilation
* Current vasopressor use
* Known immunosuppression
* Received interferon therapy within 30 days before screening
* Systemic inflammatory responses within 30 days prior to screening, such as cerebral infarction, myocardial infarction, or surgery
* Received vaccine in the past 30 days
* Active tuberculosis
* With contraindications for antiviral treatment
* Unable to obtain eligible samples
* Co-infected with influenza and COVID-19
Age 12 Follow-up of Early Preventive Intervention (Memphis)

To examine the impact of prenatal and infancy home visiting by nurses from child age 2 through 12.

This study is a longitudinal follow-up of 679 low-income women (89% African American) and their firstborn and subsequent children who have participated in a randomized trial of prenatal and infancy home visiting by nurses in Memphis, Tennessee since 1988. The study was conducted when the first-born children completed sixth grade, at around their 12th birthday.

The current follow-up was designed to determine whether: a) nurse-visited women differ from comparison group women in their life-course outcomes (the number and spacing of subsequent pregnancies and births; the rates of marriage and cohabitation with the father of the child; their employment, career growth, economic self-sufficiency, and welfare dependence; and behavioral problems due to substance abuse; arrests for serious misdemeanors and felonies); b) children of nurse-visited women differ from comparison-children in their academic achievement, placements in special education, rates of grade retention, conduct in school, and academic achievement; c) there are lower rates of developmental disability, grade retention, placement in special education, and school disciplinary actions among subsequent children born to nurse-visited women; d) nurse-visited families have fewer government expenditures and higher taxes paid; e) the effects of the program on child outcomes are concentrated on children born to women with low psychological resources; f) the effects of the program on maternal life course and government costs are concentrated on women with high psychological resources; g) the effects of the program on children are greater in schools and neighborhoods that contain greater risks for academic and behavioral problems; h) the effect of the program on children's disruptive behavior problems is explained by the combined effects of the program on maternal life-course, qualities of parental care-giving, and children's sequential processing skills, and aggressive and violent themes, reliance on adults, and story incoherence in their responses to the McArthur Story Stem Battery at earlier assessments. Data will be derived from maternal interviews and reviews of state administrative and school records. Results from this trial will provide policy makers with an estimate of likely long-term effects of this program when it is conducted in close to real-life conditions.

Eligibility Criteria:
Inclusion Criteria:

* Women \<29 weeks gestation
* No previous live births
* At least 2 socio-demographic risk characteristics; e.g. unmarried, \<12 years of education, unemployed.
The Evaluation of Artificial Intelligence in Lifestyle Management of Diabetic Patients in Community

The goal of this clinical trial is to learn about the application and effectiveness evaluation of artificial intelligence (AI) in lifestyle management of diabetic patients in community.

To determine the effectiveness of lifestyle intervention through AI on diabetic patients, whether it can improve blood sugar/ blood pressure/ body weight/ blood lipid control in people with type 1 or type 2 diabetes? Then find related risk factors. Participants will complete the basic information, diet structure, use of dietary supplements, living habits, and exercise according to the AI scale (AI scale can be entered through we-chat mini program search), and provided personalized lifestyle intervention plan according to the survey result, while the control group received routine lifestyle guidance. All included patients would fill in the patient's medication information according to the information content of the machine reading card, and follow up whether the medication is adjusted. The patient was included in the diabetes management we-chat group, followed up for 3 months /6 months according to the visit plan. The experimental group filled in the lifestyle assessment scale again, and personalized lifestyle intervention programs were provided according to the survey results, while the control group received routine follow-up and lifestyle guidance. Researchers will compare the two groups to see if the control of blood glucose, blood pressure, blood lipids and BMI of the experimental group after 6 months of AI-based lifestyle intervention was better than the control group.

Eligibility Criteria:
Inclusion Criteria:

* Well informed of the procedures of this trial and informed consent is obtained
* 18-80 years old, gender is not limited
* Diagnosed diabetes (according to WHO1999 diagnostic criteria)
* Well compliance

Exclusion Criteria:

* Pregnant or lactating
* Poor blood glucose control (HbA1c\>11%)
* A history of malignant tumor
* Abnormal liver or renal function \[defined as alanine aminotransferase (ALT)\>2.5 times higher than normal range, or eGFR\<30 mL/min per 1.73 m2\]
* Poor blood pressure control \[systolic blood pressure (SBP)\>180mmHg, or diastolic blood pressure (DBP)\>110mmHg
* With severe heart disease, cardiac function worse than grade II, anemia (Hb\<9.0g/d1)
* Blood routine test indicates that the white blood cell count (WBC) \<3\*109/L
* Body Mass Index (BMI)\<18.5 or ≥35kg/m2
* Drug or alcohol abuse
* Accompanying mental disorder who can't collaborate
* Abnormal digestion and absorption function
* Other endocrine diseases
* Other chronic diseases needed long-term glucocorticoid treatment
* With severe infection, immune dysfunction
A Study Comparison of Clinical Outcome After Different Rate of Infusion in Caudal Epidural Steroid Injection

The purpose of this study is to determine the effects of different rates of Caudal Epidural Steroid Injection (CESI) on clinical outcomes of the patients.


Eligibility Criteria:
Inclusion Criteria:

* lumbosacral spinal stenosis with radiculopathy
* no improvement after conservative treatment for 6 weeks

Exclusion Criteria:

* previous CESI or spinal surgery
* skin infection at injection site
* uncontrolled diabetes mellitus
* abnormal coagulogram
* vertebral fracture
* previous history of allergy to steroid or anesthetic agent
Effect of a Life Coaching Intervention on the Well-being and Distress of Physicians

There is a widespread epidemic of distress and burnout (i.e., extreme distress) among Canadian physicians. Burnout is costly to physicians, patients, and healthcare organizations as it compromises physicians' own health and reduces their capacity to deliver high quality, safe care to patients. Life coaching delivered by certified coaches is a personal development tool. Life coaching has been proven to help individuals maximize their strengths and skills to handle stressors, regain control over their lives, act according to their core values, and achieve their full potential, consequently reducing their vulnerability to burnout. The investigators will evaluate life coaching for physicians' well-being in the current Canadian context. Physicians from centres in Canada will be randomly assigned to life coaching (intervention) or no coaching (control) group. The coaching group will receive a 1-hour initial coaching session followed by five 30-minute coaching sessions occurring at a frequency of every 2 to 3 weeks within 5 months (total of 3.5 coaching hours). All coaching sessions will be delivered virtually by certified life coaches. The investigators will assess the impact of coaching on physician distress and quality of life before and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Registered staff physician, resident, or fellow
* Currently practicing in Canada
* (For the 'Francophone minority patients' group only) Sometimes conducts thorough consultations completely in French for French-speaking patients outside Quebec

Exclusion Criteria:

* Previously received life coaching in the last 5 years
* Currently receiving psychotherapy
Prospective Evaluation of the Non-invasive ICP HeadSense Monitor in TBI Patients Undergoing Invasive ICP Monitoring

Patients with severe traumatic brain injury (TBI) are admitted to the intensive care unit (ICU). Under certain condition (such as a impaired consciousness) the intracranial pressure (ICP) is measured. An increase in the intracranial pressure might suggest secondary neurological deterioration and is considered an alarming symptom. Current practice is to insert an invasive monitor through a burr hole in the skull with the risk of bleeding and infection. Using a new type of ICP monitor (HeadSense) it is possible to measure ICP non-invasively through an acoustic signal.

In this pilot study, the investigators will prospectively collect relevant clinical data on 15 TBI patients with an inserted invasive ICP monitor. Each enrolled patient will be monitored in parallel to the invasive ICP monitor with the HeadSense's ICP monitor. Subjects who meet the study's inclusion and exclusion criteria will be enrolled in the study. Family members will be asked for consent. The patient's clinical condition will be recorded in a case record form (CRF).

Once the patient is inclined with his upper body 30 degrees to the bed and the invasive ICP monitor displays the pressure values, the clinical procedure can begin. Once the HeadSense's monitor is calibrated it is connected to the front end that is placed on the patient's ears. Each recording session will be ½-48 hours long, depending on the patient's clinical condition. In case the ICP monitor is still inserted to the patient's brain in the following day, recording sessions will continue until the ICP monitor is removed.

After the study, the patient's ears will be examined for internal ear infection or irritation that might be caused by the ear buds. Patient adverse events will be documented on the case report forms in case they occurred, and the family or advocate of the patient will be informed. In case of clinical relevant adverse event, appropriate clinical action will be taken.

As the procedure does not affect the patient management, there is no need to provide any specific medical care related to the trial. Patients will receive the relevant clinical care related to their clinical management, without any consideration to their participation in the trial.

Once the data collection is done, results will be analyzed by comparing ICP readings from both devices. The end point of the study is to collect at least half an hour of ICP monitoring for each participant.

Eligibility Criteria:
Inclusion Criteria:

* Have an invasive ICP monitoring
* Male or Female in the age range of 18 years and older

Exclusion Criteria:

* Local infection in the ear.
* Pregnant/lactating women
Evaluation of an Intensive Education Program on the Treatment of Tobacco Use Disorder for Pharmacists: a Randomized Controlled Trial

In Qatar, tobacco use is one of the main causes of premature deaths and preventable diseases. As per the 2013 Global Adult Tobacco Survey (GATS), 12.1% of adults and 20.2% of men in Qatar smoke tobacco, and 55.4% of this smoke an average of 16 cigarettes or more per day. Moreover, 15.7% of school students aged 13 to 15 years currently use some form of tobacco according to the 2013 Global Youth Tobacco Survey (GYTS). In Qatar, tobacco-related diseases including cardiovascular diseases and cancers are highly prevalent. In an effort to reduce tobacco use, Qatar has ratified the WHO Framework Convention on Tobacco Control (FCTC) and has implemented many tobacco control initiatives. In spite of these measures, tobacco use is still rising in Qatar. Pharmacists practicing in retail/community pharmacy are often the first port of call for individuals requiring health advice in general. Evidence has proven that they have a pivotal role in health promotion and disease prevention including tobacco cessation. Hence, pharmacists have excellent opportunities to reduce tobacco use in Qatar. Yet, ambulatory and community pharmacists in Qatar are not sufficiently contributing to tobacco control. Based on published data, only 21% of community pharmacists in Qatar always or most of the time ask patients about their smoking status. Furthermore, when asked about their smoking cessation training, 89% of pharmacists did not receive any kind of education or training about smoking cessation counseling in the past. In an effort to build the capacity of pharmacists in Qatar, the aim of the proposed study is to design, implement and evaluate an intensive education program on tobacco treatment for pharmacists in Qatar. The study will be a prospective randomized controlled trial comparing the effectiveness of the education program on pharmacists' tobacco cessation-related knowledge, attitudes, self-efficacy, and skills.


Eligibility Criteria:
Inclusion Criteria:

* Retail/community pharmacists practicing in Qatar will be eligible for participation in the study.

Exclusion Criteria:

* None
Effectiveness and Handling of Spiolto® Respimat ® in COPD Patients - Italy

The purpose of the study is to measure changes in physical functioning in chronic obstructive pulmonary disease (COPD) patients being treated with Spiolto® Respimat® after approximately 6 weeks in routine clinical practice.

Purpose:

Eligibility Criteria:
Inclusion criteria:

1. Written informed consent prior to participation
2. Female and male patients = 40 years of age
3. Patients diagnosed with COPD and requiring long-acting dual bronchodilation (LAMA + LABA) treatment according to approved Spiolto® Respimat® SmPC and therapeutic plan recommendation

Exclusion criteria:

1. Patients with contraindications according to Spiolto® Respimat® Summary of Product Characteristics (SmPC)
2. Patients who have been treated with a LABA/LAMA combination (free and fixed dose) in the previous 6 months
3. Patients continuing LABA-Inhalative Corticosteroids (ICS) treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta-agonists
4. Patients for whom further follow-up is not possible at the enrolling site during the planned study period of approx. 6 weeks
5. Pregnancy and lactation
6. Patients currently listed for lung transplantation
7. Current participation in any clinical trial or any other non-interventional study of a drug or device
The Safety/Efficacy of Rifaximin With/Without Lactulose in Participants With A History of Recurrent Hepatic Encephalopathy

The purpose of the study is to evaluate if rifaximin alone or rifaximin plus lactulose delays the onset of hepatic encephalopathy (HE) in participants with cirrhosis who have had a previous episode of HE.


Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-lactating females greater than or equal to (≥) 18 years old.
* In remission from demonstrated overt HE (Conn score 0 or 1).
* Have had one or more episodes of overt HE associated with cirrhosis within 6 months prior to screening visit (Day -7 to -1).
* Participant has a close family member or other personal contact who is familiar with the participant's HE and can provide continuing oversight to the participant and is willing to perform as caregiver for the participant during the conduct of the trial.

Exclusion Criteria:

* Participant has been diagnosed with human immunodeficiency virus (HIV) as determined by medical history.
* History of tuberculosis infection.
* Participant has been diagnosed with chronic respiratory insufficiency.
* Participant has been diagnosed with a current infection for which they are currently taking oral or parenteral antibiotics.
* Renal insufficiency requiring routine dialysis.
* Participant has an active spontaneous bacterial peritonitis(SBP) infection.
* Intestinal obstruction or inflammatory bowel disease.
* Participant has active malignancy within the last 5 years prior to screening visit, except basal cell carcinoma of the skin, or if female, in situ cervical carcinoma that has been surgically excised.
* Current gastrointestinal (GI) bleeding or has a history of a GI hemorrhage of sufficient severity to require hospitalization and a transfusion of ≥2 units of blood within 3 months prior to screening visit.
* Participant is anemic, as defined by a hemoglobin of less than (\<) 8 grams/deciliter (g/dL).
* Scheduled to receive a liver transplant within 1 month of screening.
Clinical Performance of One-shade Universal Dental Resin Composite as Posterior Restoration

This study is aimed to evaluate the clinical performance of new One-shade universal composite resin as posterior restoration using US Public Health Service "USPSH" criteria for color match, marginal adaptation, surface texture, retention, recurrent caries and others after 1, 3, 6 and 9 months.

One operator will place all restorations under rubber-dam isolation. The patients will receive restorations with both materials, randomly after shade selection (The shade of single shade universal resin composite "Omnichroma" will be taken before and after placement into the cavity). During the referred period, only the two composites in study will be placed in posterior teeth in the dental office. The various materials' application procedure will be applied according to manufacturer's instructions.

Eligibility Criteria:
Inclusion Criteria:

* • They should have an acceptable oral hygiene level.

  * Presence of at least two occlusal carious lesions to be restored with two different types of composite.
  * The two studied materials restorations should be used in approximately the same sized lesions or within the same extension.
  * Age range between 25 and 45years.

Exclusion Criteria:

* • Severe or active periodontal or carious disease and heavy bruxism or a traumatic occlusion

  * Patients with a compromised medical history, or had received therapeutic irradiation to the head and neck region.
  * Alcoholic and smoker patients.
  * Patients had participated in a clinical trial within 6 months before commencement of this trial.
  * Patients unable to return for recall appointment