cyrilzakka/clinical-trials huggingface dataset:
Compare Pharmacokinetics, Safety, and Immunogenicity of HLX11 vs. Perjeta in Healthy Chinese Male Subjects

This is a randomised, double-blind, intravenous single-dose, four-arm parallel study designed to compare the PK of HLX11 and US, EU, and CN-sourced Perjeta® in healthy Chinese adult male subjects, and to assess the safety, tolerability, and immunogenicity of these 4 drugs.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Chinese males
* aged ≥ 18 and ≤ 45
* body mass index (BMI) ≥ 19 and ≤ 26 kg/m2
* LVEF≥ 55%

Exclusion Criteria:

* A history of any serious clinical disease such as haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, mental, neurological diseases, and tumour, or allergic diseases
* Use of a monoclonal antibody or any biological product within 6 months before study drug administration
* A history of allergic reactions or anaphylaxis, including such reactions to any drug or excipient in the clinical study
* Use of prescription drugs, over-the-counter drugs (OTC), or traditional Chinese medicine (TCM) (excluding vitamins, mineral supplements, and dietary supplements) within 28 days before study drug administration
* A history of blood donation within 3 months before study drug administration
* Participation in other clinical study and use of the investigational product/comparator within 3 months before study drug administration
* Positive for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or treponema pallidum antibody
* A history of drug abuse
* Failure to comply with protocol requirements, instructions, and study limitations, such as uncooperative attitude, failure to return to the study site for follow-up visits, or failure to complete the entire clinical study, as judged by investigators
ColoAssist vs. MEI

Colonoscopy aims to investigate the entire colon by advancing the colonoscope tip from the rectum to the cecum, a process called cecal intubation. Cecal intubation may be difficult for different reasons, and features of the colonoscope and the use of imaging devices may influence the success rate. We want to compare the performance of a new colonoscope with novel features including gradual stiffness with that of a colonoscope supplied with a magnetic endoscope imaging (MEI) device. The hypothesis is that the performance of the new instrument is non-inferior to the MEI system.

The recommended cecal intubation rate in colorectal cancer (CRC) screening is 95%. The MEI system allows real time monitoring of the colonoscope position within the colon and is considered to be a useful supplement to achieve cecal intubation. However, the MEI system is costly, and trial results are equivocal regarding the actual benefits. A newly designed colonoscope (ColoAssist) with gradual stiffness throughout the colonoscope shaft has been developed to improve insertability. We want to investigate if we can achieve equal performance results with the ColoAssist instrument as with the MEI system in CRC screening. The study is designed as a two-center, single-blinded, randomized, controlled non-inferiority trial.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion in an ongoing colorectal cancer screening trial (NCT 00883792)

Exclusion Criteria:

* Excluded from the ongoing screening trial (NCT 00883792)
* Inability or unwilling to provide informed consent
The Role of Audiovisual Biofeedback on Image Quality During 4D Anatomic and Functional Imaging

This study will investigate whether audiovisual biofeedback, in which visual and audio cues are used to regulate the patient's breathing, can increase the image quality of 4D CT and 4D PET scans.


Eligibility Criteria:
Inclusion Criteria:

Required for inclusion in this study are:

* Informed consent
* Diagnosis of AJCC Stage I-III lung cancer of any histology to be treated using radiotherapy at Stanford Cancer Center
* Age 18 or greater
* Painfree in supine position
* Karnofsky performance status 50 or greater

The inclusion of educationally disadvantaged, decisionally impaired or homeless people are allowed if informed consent, in the opinion of the consenting investigator (study PI, co-PI or research nurse), is obtained.

Exclusion Criteria:

No

* Pregnant women
* Stanford employees
* Stanford students
* Prisoners will be eligible for the study.
RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular Surgery

This study assesses the efficacy and safety of two concentrations of RTA 408 Ophthalmic Suspension in the treatment of patients who have inflammation and pain following ocular surgery.

Following ophthalmic surgery, the current standard of care includes a topical ophthalmic corticosteroid or other anti-inflammatory agent to treat ocular inflammation and improve patient comfort. If left untreated, inflammation of the eye may result in further ocular complications including scarring, vision loss, or blindness. Although the exact dosing regimen is physician-dependent, patients are typically prescribed a topical corticosteroid for a period of 2-4 weeks following surgery, being tapered over the course of delivery as the inflammation subsides. Topical anti-inflammatory agents are usually administered multiple times per day, particularly in the early period following ophthalmic surgery. Continuing efforts in drug development aim to identify alternatives to ophthalmic corticosteroid use, due to their well-known local and systemic negative side effects.

Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.

Eligibility Criteria:
Inclusion Criteria:

1. Be greater than or equal to 18 years of age of either sex or any race;
2. Have undergone unilateral cataract extraction via phacoemulsification on the day prior to study enrollment/randomization;
3. Have a grade of ≥2 in anterior chamber cell score on day after surgery (Day 1);
4. Have a potential post-operative pin-hole visual acuity (VA) of greater than 1.0 logarithm of the minimum angle of resolution (logMAR) in the operative eye and fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart;

Exclusion Criteria:

1. Have any intraocular inflammation present in the study eye during the screening slit lamp examination;
2. Have a score greater than "0" on the Ocular Pain Assessment at Screening in the study eye;
3. Have an immunosuppressive disease or an autoimmune disease that in the opinion of the Investigator could affect the quality of the ocular surface;
4. Have active or chronic/recurrent ocular or systemic disease that is uncontrolled and will likely affect wound healing;
5. Have an intraocular pressure (IOP) ≤ 5 mmHg in either eye;
6. Require the use of a contact lens or a collagen shield within 72 hours of investigational drug treatment or during the study period in the study eye; be unwilling to discontinue use of contact lenses during study period in the study eye;
7. Require use of non-diagnostic topical ophthalmic solutions (other than perioperative mydriatics, anesthetics and antiseptics, prophylactic antibiotics, lid scrubs for mild blepharitis, or artificial tears for the management of dry eye) in the study eye for the duration of the study;
Very Early Surfactant and NCPAP for Premature Infants With RDS

The present study will test the use of very early nasal continuous airway pressure(NCPAP)with and without surfactant in premature infants with clinical evidence or respiratory distress syndrome. We hypothesize that premature infants exposed to very early NCPAP and surfactant will require less mechanical ventilation compared to those premature infants exposed to NCPAP alone.

Premature infants who are not intubated during the first 15 minutes of life and who develop clinical evidence of respiratory distress or need for oxygen requirement between 15 and 60 minutes of life, will be placed on bubble NCPAP of 6 cm H2O. Randomization envelops will them be opened and patients will be assigned to continuation on NCPAP alone (Control Group) or to NCPAP plus very early surfactant therapy (Treatment Group). Patients assigned to the treatment group will be transiently intubated for surfactant administration, extubated, and placed back on NCPAP of 6 cm H2O. Both groups will then be followed over time to determine which infants meet treatment failure criteria defined as: Treatment failure was defined a priori by either failure of adequate oxygenation or ventilation as follows: "1" FiO2 greater than 0.75 for more than 30 minutes to maintain SpO2 within the pre-established target ranges, "2" persistent or recurrent desaturation below 80% that did not respond to suctioning of the airways and PPV, "3" PCO2\>65 mmHg and pH\<7.22 on an arterial or capillary blood gas analysis, in association with increased work of breathing. Infants in the Treatment Group who cannot be extubated after their initial dose of surfactant because of clinical instability will be analyzed as treatment failures. Premature infants that meet treatment failure criteria on either arm will be intubated and placed on mechanical ventilation and given surfactant rescue doses according to the criteria of the participating institutions. Premature infants with respiratory distress syndrome who do not meet treatment failure criteria in both groups will remain on NCPAP until their respiratory failure improves.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age of 27 to 31 6/7 weeks,
* Postnatal age between 15 and 60 minutes,
* Supplemental oxygen requirement or evidence of increased work of breathing (tachypnea, intercostal retractions, nasal flaring, or grunting), and
* Prenatal consent.

Exclusion Criteria:

* Apgar score less than 2 at 5 minutes,
* Intubation prior to randomization,
* Prenatal diagnosis of major congenital anomalies,
* Prolonged rupture of membranes of greater than 3 weeks duration, and
* Infants who were likely to be transferred to another center soon after birth were not enrolled in the study.
Wear Behavior of Milled Posterior Crowns Fabricated From the New Monolithic Zirconia 5Y-TZP/3Y-TZP Compared to Lithium Disilicate

In-vitro studies do not represent the actual masticatory environment and cannot simulate the intricate chewing pattern. Hence, there is a need for an in vivo study evaluating the wear potential of the newly introduced strength - color gradient multilayered zirconia IPS e.max ZirCAD Prime (5Y-TZP/3Y-TZP) and compare it to Lithium Disilicate IPS e.max CAD which has proven to have favorable wear patterns.

* There will be no difference in wear caused by monolithic Zirconia (5Y-TZP/3Y-TZP) IPS E-max ZirCad Prime and Lithium Disilicate IPS e.max CAD to the antagonist.
* There will be no difference in the wear of the new monolithic zirconia IPS e.max ZirCAD Prime and lithium disilicate IPS e.max CAD.

Eligibility Criteria:
Inclusion Criteria:

* All subjects are required to:

  1- Be aged 21-50 years old, be able to read and sign the informed consent document. 2- Psychologically and physically able to withstand conventional dental procedures.

  3- Patients with mutilated posterior teeth indicated for full coverage restorations.

  4- Patients with sound natural antagonists. 5- Able to attend punctually for preplanned visits and evaluation. 6- Have no active periodontal or pulpal diseases.

  7- There should be no apparent loss or wear in opposing enamel.

Exclusion Criteria:

1. Patient with active resistant periodontal diseases.
2. Patients with parafunctional habits and bruxism.
3. Patients with poor oral hygiene, high caries risk and uncooperative patients. 3- Pregnant women.
4. Patients in the growth stage with partially erupted teeth. 5- Psychiatric problems or unrealistic expectations.

6- Lack of opposing dentition in the area of interest. 7- Restored occlusal surface opposing the planned restoration. 8- The presence of a removable or fixed orthodontic appliance.
Functional Medicine Health Coaching

The goal of this research is to evaluate the feasibility and self-reported health outcomes of functional medicine health coaching in elimination diets among clinicians receiving training in functional medicine.

A randomized controlled clinical trial of a 5-session functional medicine coaching and elimination diet intervention will be conducted to achieve the purpose of this study. The research team hypothesizes that functional medicine health coaching to support the elimination diet will improve physical and mental health outcomes better than the control condition of a self-guided elimination diet.


Eligibility Criteria:
Inclusion Criteria:

* Agree to adopt the elimination diet as outlined by study sponsor with no pre-planned interruption
* Able to understand and write English
* Voluntarily consent to the study and understand its nature and purpose including potential risks and side effects

Exclusion Criteria:

* Eating disorders within the past 10 years
* Currently pregnant or breastfeeding
* Nursing home residents, other institutionalized persons, prisoners, any other vulnerable participants
Use of Surface Electromyography Biofeedback to Improve Reaching in Children With Cerebral Palsy

A newly-developed device for biofeedback of surface EMG will be used to either increase or decrease activity in the muscles of children with poor reaching due to cerebral palsy.

Children ages newborn to 21 with a diagnosis of arm weakness, hypertonia, or hyperkinesia due to cerebral palsy will be recruited. A muscle that is either over-active or under-active will be selected for each child. The child will be provided with the device to wear for 1 month in order to call attention to the identified muscle. At the beginning and end of the month, reaching will be assessed using three-dimensional kinematic motion capture. The outcome measure will be the speed and curvature of reaching to a target in front of the child.

Eligibility Criteria:
Inclusion Criteria:

* weakness, hypertonia, or hyperkinetic disorder affecting one or both arms
* reduced speed or quality of reaching

Exclusion Criteria:

* any condition that would increase the risk of participation
Bipolar Cohort Neunkirchen, Final Statement

monitoring system and data base for long term follow up of various treatment strategies in a naturalistic setting of recurrent affective disorders (unipolar, bipolar) open study design, prospective \& retrospective

all hospitalized patients of a defined mixed urban and more rural area were consecutively interviewed at admission and entered into the data base. at discharge they gave written informed consent for further tracking and interviews.

Eligibility Criteria:
Inclusion Criteria:

* bipolar

Exclusion Criteria:

* all other diagnoses
Brain Maturation in Children With Localization Related Epilepsy

This project intends to investigate children with idiopathic and cryptogenic localization related epilepsies, using a longitudinal assessment of structural and functional MRI data, in relation to neuropsychological evaluation. The rationale is primarily based on: 1) the frequent observation of selective cognitive dysfunctions in such children, the pathophysiology of which remains largely uncertain; 2) the recent major advances in the MRI investigation of brain maturation showing striking age and region dependant patterns.

The primary hypothesis is that some children with localization related epilepsies suffer from altered maturation in the epileptic brain regions, and that this abnormal maturation affects their cognitive abilities. 100 children with localization related epilepsies and 100 matched controls will be prospectively enrolled during the first two years of the disease (for patients) and benefit from a comprehensive phenotypic and neuropsychological evaluation once a year for 5 years. The brain maturation of these children will be longitudinally assessed using structural and functional MRI, and correlated with neuropsychological data. Investigators hope to demonstrate that children with localization related epilepsies and cognitive dysfunctions suffer from an abnormal brain maturation in regions underlying the epileptic activity and the altered cognitive processes. The finding could partly bridge the gap between these two abnormalities and help better understand their interaction and respective dynamic. Once validated, the study of regional brain maturation in children with epilepsy might be further used as a reliable surrogate marker or predictor of associated cognitive dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* motivation to participate in the study for 5 years
* for patients - one of the following diagnostics - BCECTS (benign childhood epilepsy with centro-temporal spikes), focal cryptogenic epilepsy of childhood, Panayiotopoulos syndrome, diagnosis established according to the current diagnostic criteria (ILAE, 1989)
* for patients - no anti-epileptic drug for 24 months
* normal MRI if available before inclusion
* signed consent by on of the parents

Exclusion Criteria:

* associated neurological and psychiatric diseases
* other epileptic syndromes
* other chronic severe disease
* contra-indication for performing an MRI examination
* claustrophobia
A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With PNH

Evaluation of the Efficacy and Safety of Pegcetacoplan in Patients with Paroxysmal Nocturnal Hemoglobinuria .


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years old (inclusive).
* Have LDH ≥1.5 x ULN at the screening visit.
* Have PNH diagnosis, confirmed by high sensitivity flow cytometry (granulocyte or monocyte clone \>10%).
* Have Hb less than the lower limit of normal (LLN) at the screening visit.
* Have ferritin greater than/equal to the LLN, or total iron binding capacity (TIBC) less than/equal to ULN at the screening visit, based on central laboratory reference ranges. If a subject is receiving iron supplements at screening, the Investigator must ensure that the subject's dose has been stable for 4 weeks prior to screening, and it must be maintained throughout the study. Subjects not receiving iron at screening must not start iron supplementation during the course of the study.
* Body mass index (BMI) ≤ 35 kg/m2 at the screening visit.
* Have a platelet count of \>50,000/mm3 at the screening visit.
* Have an absolute neutrophil count \>500/mm3 at the screening visit.

Exclusion Criteria:

* Treatment with any complement inhibitor (eg, eculizumab) within 3 months prior to screening.
* Hereditary complement deficiency.
* History of bone marrow transplantation.
* Concomitant use of any of the following medications is prohibited if not on a stable regimen for the time period indicated below prior to screening:

  * Erythropoietin or immunosuppressants for at least 8 weeks
  * Systemic corticosteroids for at least 4 weeks
  * Vitamin K antagonists (eg, warfarin) with a stable international normalized ratio (INR) for at least 4 weeks
  * Iron supplements, vitamin B12, or folic acid for at least 4 weeks
  * Low-molecular-weight heparin for at least 4 weeks
A Medication Plan for Safer Medication Treatment in Older Persons

Harm from medications is still a concern in an aged population. As medication treatment for older persons many times are complex, a feasibility study can be helpful to support decisions about future evaluation and implementation of an intervention.

In this study, the overall aim is to assess feasibility, acceptability and potential effects of usage of a co-designed medication plan for older persons with medication treatment.

The study will take place in the primary care setting in Sweden, and involve persons 75 years or older using five or more medications on daily basis, physicians at primary care centers and persons supporting the older person in their medication use a home.

During an appointment, the physician and older person will agree on a medication plan, that will be documented in the older person's electronic health record and printed out on paper.

After three month, the potential outcomes of a medication plan will be collected, together with data about feasibility and acceptability of the intervention. Two questionnaires will be used, addressing usability and patient safety. Moreover, remote interviews with participants will be performed to address usability and patient safety. Information about the medication plan will be collected from the electronic health record. Data analysis will be done with descriptive statistics and qualitative content analysis.

Expected outcomes are an assessment of feasibility and acceptability, and potential outcomes, to support decision on a future evaluation of the medication plan.


Eligibility Criteria:
Inclusion Criteria:

* Physicians and nurses: regular contact with the older person regarding medications, employment at a primary care center and ability to understand and communicate in Swedish
* Older persons: age \>75 years old, five or more medications on a regular basis and ability to understand and communicate in Swedish
* Next-of-kin: age \> 18 years old, regular contact with the older person regarding medications, ability to understand and communicate in Swedish

Exclusion Criteria:

* Older persons: impaired cognitive ability affecting the ability to provide informed consent (Diagnosis code for dementia) and late palliative phase, here defined as estimated life expectancy shorter than six months
* Next-of-kin: impaired cognitive ability affecting the ability to provide informed consent
Metformin Use in Rheumatoid Arthritis

Metformin has been used clinically for over 50 years, as a glucose lowering agent.

Direct and indirect anti-inflammatory effects of metformin have been reported in animal and clinical studies, and this effect is independent of its hypoglycemic effect.

Animal studies showed that metformin decreased serum C-reactive protein (CRP) level in atherogenic rabbits and decreased proinflammatory cytokines (interleukin (IL)-1β, IL-6 and tumor necrosis factor (TNF-α) in obese mice .

Moreover, metformin also suppressed osteoclastogenesis ; this may partially result from decreased expression of inflammatory cytokines that promote osteoclastogenesis in the arthritic joint.

The objective of this study is to evaluate the efficacy and safety of addition of metformin to standard disease modifying anti-rheumatic drugs (DMARDs) in patients with rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years (of both sexes) diagnosed with rheumatoid arthritis according to ACR / EULAR 2010 criteria .
* Patients with moderate to high disease activity (DAS - 28 . score greater than 3.2)
* Patients received the standard therapy (i.e. one or more conventional DMARDs) for at least three months.

Exclusion Criteria:

* Known hypersensitivity to metformin.
* Patients who have a prior diagnosis with diabetes mellitus.
* Patients receive metformin for any other indications.
* Patients with congestive heart failure.
* Patients with a history of myocardial infarction.
* Patients with severe anemia.
* Patients with active infections or other inflammatory diseases.
* Patients receiving biological therapy.
* Pregnancy or lactation.
* Patients with impaired liver functions.
* Patients with impaired kidney functions (serum creatinine concentrations ≥1.5 and ≥1.4 mg/dL in males and females respectively).
* Patients with malignancies.