cyrilzakka/clinical-trials huggingface dataset:
CholGate - The Effect of Alerting Versus on Demand Computer Based Decision Support on Treatment of Dyslipidaemia by General Practitioners

Indirect evidence show alerting physicians with clinical decision support systems (CDSS) seem to change behaviour more than requiring users to actively initiate the system. However, randomized trials comparing these methods in a clinical setting are lacking. In this study we compare the effect of Alerting physicians with a CDSS or actively requiring initiation of CDSS on the adherence of Dutch general practitioners to the Cholesterol guideline of the Dutch college of General Practitioners.

Indirect evidence show alerting physicians with clinical decision support systems (CDSS) seem to change behaviour more than requiring users to actively initiate the system. However, randomized trials comparing these methods in a clinical setting are lacking. In this study we compare the effect of Alerting physicians with a CDSS or actively requiring initiation of CDSS on the adherence of Dutch general practitioners to the Cholesterol guideline of the Dutch college of General Practitioners, using a clinical decsion support system called CholGate. This system has the functionality to provide both Alerting and On-Demand decision support. Users are free to negate the advise provided by the decision support system. The trial will have a cluster randomized structure.

Eligibility Criteria:
Inclusion Criteria:

* All general practices using only Elias electronic patient records (ISOFT b.V)
* All patients meeting the screening and treatment criteria of the Dutch college of general practitioners cholesterol guideline

Exclusion Criteria:

* Practices that used paper based records
The Effects of Flow Settings During High Flow Nasal Cannula for Adult Hypoxemia Patients

High flow nasal cannula (HFNC) delivers oxygen at a flow which exceeds the patient's inspiratory flow demand in order to improve oxygenation. Numerous randomized control trials and meta-analyses have shown that HFNC improves oxygenation and helps avoid intubation in hypoxemic patients, as well as reduce work of breathing, improve ventilation, and decrease hypercapnia in COPD patients. Flow settings play a critical role when using HFNC, as increased flow can reduce inspiratory effort, improve ventilation, and dynamic lung compliance. However, flow rates used in many studies vary widely. The clinical effects of different HFNC flow setting, specifically to match or over than a patients' own inspiratory flow, is still unknown.

High flow nasal cannula (HFNC) delivers oxygen at a flow which exceeds the patient's inspiratory flow demand in order to improve oxygenation. Numerous randomized control trials and meta-analyses have shown that HFNC improves oxygenation and helps avoid intubation in hypoxemic patients, as well as reduce work of breathing, improve ventilation, and decrease hypercapnia in COPD patients. Flow settings play a critical role when using HFNC, as increased flow can reduce inspiratory effort, improve ventilation, and dynamic lung compliance. However, flow rates used in many studies vary widely, from 20-40 LPM in COPD patients and 30-60 LPM in hypoxemic patients. The clinical effects of different HFNC flow setting, specifically to match or over than a patients' own inspiratory flow, is still unknown.

Eligibility Criteria:
Inclusion Criteria:

Adult patients (Age \> 18yrs and \< 90yrs) who need nasal cannula oxygen flow ≥ 5 L/min to maintain SpO2 at 90-97%.

Exclusion Criteria (Common): - Unable to use resuscitation mask, such as facial trauma, claustrophobia

* Inability to verbally communicate;
* Pregnant
* Inability to breathe via nose, such as nasosinusitis, stuffy nose or nasal obstruction, etc.
* Ordered SpO2 goal is above 97%
* FIO2 needs ≤ 0.4
* Using inhaled pulmonary vasodilator via HFNC
Effects of Probiotics Supplementation on Intestinal Microbiome in Malignancy Pts(Get Pelvic/Abdominal Rtx)

The purpose of this study is to evaluate the effect of probiotics to improve the intestinal microbiome in malignancy patients who get pelvic/abdominal radiotherapy.

Pelvic/abdominal radiotherapy carries a risk of complications. Acute complications include diarrhea, abdominal pain, inflammatory change in the small intestine. Radiation creates changes in bacterial microbiome, the vascular permeability of the mucosal cells and in intestinal motility. Probiotics were known to improve gastrointestinal function. This is a randomized, double-blind, placebo-controlled study involving 26 patients designed to evaluate the effect of probiotics to change the intestinal microbiome in in patients undergoing concurrent pelvic/abdominal RT.

Eligibility Criteria:
Inclusion Criteria:

* Patients who current diagnosis of gynecologic cancer or rectal cancer and never previously received radiation therapy and will use for the first time radiotherapy at department of radiation oncology, Seoul National University Hospital.
* ECOG performance status (PS) of 0, 1, or 2.
* signed written informed consent.
* Patients who get pelvic/abdominal radiotherapy.

Exclusion Criteria:

* People who use antibiotics that can affect intestinal microorganism growth within one month before the study.
* Patients who use probiotics within one month before the study.
* Patients received neoadjuvant chemotherapy.
* Acute enteritis symptoms (diarrhea, abdominal pain, nausea, vomiting) for the patient.
* Patients diagnosed with inflammatory bowel disease.
* Patients suspected gastrointestinal infections and other infectious diseases.
* Suspected infections from blood tests : Excessive rise in WBC, ESR, CRP
* Suspected renal insufficiency from blood tests
Effects of Yakson Method and Swaddling on Pain and Physiological Parameters

Type of Study: The study was planned to be conducted in a randomized controlled experimental design.

Place and Time of the Research: Institutional permission will be obtained from the Balcalı Training and Research Hospital in Adana for the collection of research data. Researchers commit to start data collection after obtaining institutional permission. The data collection process will take 1 year after obtaining the institutional permission.

48 newborns who are suited the inclusion criteria will be included in the study. Participants will be assigned to 3 groups according to randomization: Swaddling, Yakson Method, and Control.

Total processing time and baby's crying time are calculated by watching video recordings. In order to find the total procedure time, starting from the puncture of the baby's heel, the time until the dry cotton is placed on the baby's heel after the blood collection process is completed is calculated. The heart rate and SpO2 are noted by the investigator during the heel lancing procedure. Pain assessment of infants is done by two independent neonatal nurses, apart from the researcher, by watching video recordings. The scores given by the two observers will be evaluated by making inter-observer harmony. Before the evaluation, the nurses will be trained about the scale and its evaluation.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria for Newborn:

* Born at term (38-42 weeks)
* Healthy newborn
* Absence of congenital anomaly
* No analgesic or sedative medication has been administered in the last 6 hours
* Parent's consent for inclusion in the study in accordance with the consent form

Inclusion Criteria for Mother:

* Mother's willingness to participate in the study
* The mother can be mobilized and not have a physical disability (so that she can appyl Yakson therapy for her baby)
* Being communicative

Exclusion Criteria:

* Babies whose blood cannot be drawn on the first try
Efficacy and Safety of Low-dose Conbercept for Retinopathy of Prematurity Therapy

Evaluating the Optimal Effective Dose and Safety of Conbercept in Treating Retinopathy of Prematurity (ROP)


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants with less than or equal to 2000 grams of birth weight or less than or equal to 32 weeks of gestational age
* Bilateral type 1 ROP with one of the following retinal findings in each eye
* Zone I, stage 1+, 2+, 3+/- disease, or
* Zone II, stage 2+, 3+, disease, or
* A-ROP

Exclusion Criteria:

* Preterm infants with stage 4 or 5 ROP in one or both eyes
* Have received any previous surgical or nonsurgical treatment for ROP, including laser photocoagulation, anti-VEGF therapy, vitrectomy
* Have been previously exposed to any intravitreal or systemic anti-VEGF agent (either the patient or the mother during this child's pregnancy)
* Have used (either the patient or the mother) other investigational drugs as part of another clinical study (other than vitamins and minerals) within 30 days or within 5 half-lives of the other investigational drug, whichever is longer
* Have active ocular infection within 5 days before or on the day of first investigational treatment
* Have a history of hypersensitivity (either the patient or the mother) to any of the investigational treatments or to drugs of similar chemical classes
* Have any contraindication for intravitreal injection clearly stated in the instructions
* Have any ocular structural abnormality that may affect efficacy assessments
* Have a history of any other congenital or systemic conditions that are assessed by the investigator to have a significant risk of severe impact on visual function
* Have any other medical conditions or clinically significant comorbidities or personal circumstances that are assessed by the investigator to have a clinically relevant impact on study participation, any of the study procedures, or on efficacy assessments
Vitamin D Supplementation and CD4 Count in HIV-Infected Children

To find out if vitamin D supplementing can lead to an improvement in immunological status in HIV-infected children as part of routine clinical care

The objective of this study is to determine the impact of vitamin D on immunological status in HIV-infected children as measured by CD4 count (CD4 percent). We will determine if vitamin D supplementation leads to a measurable change in CD4 count (CD4 percent) in HIV-infected children in the context of routine clinical care.

Specific study questions are:

1. Does vitamin D supplementation lead to a change in CD4 percent (CD4 count) in HIV-infected children?
2. Do the serum levels of the active form of vitamin D \[1, 25(OH)2D and 25(OH)D\] correlate with CD4 percent (CD4 count) in HIV-infected children?

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected children as defined by ≥ 2 positive HIV DNA PCRs and/or HIV cultures of blood for children less than 18 months of age, or by positive screening and confirmatory serologic testing in those older than 18 months of age
* Stable HIV disease, defined by the absence of change in HIV clinical or immunologic category during the preceding 6 month period, prior to commencing the study
* Age 3 years through 18 years
* Voluntary informed consent

Exclusion Criteria:

* Any antiretroviral medication change in the 6 months prior to the study, or any anticipated antiretroviral medication change during the duration of the study
* Active participation in another treatment trial
* Serum calcium \< 2mmol/L at baseline
A Safety and Tolerability Study of INCAGN02385 in Select Advanced Malignancies

The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02385 in participants with advanced malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
* Disease progression after treatment with available therapies that are known to confer clinical benefit, or intolerant to treatment, or refuse noncurative standard treatment. There is no limit to the number of prior treatment regimens.
* Participants with advanced or metastatic cervical cancer, MSI-high endometrial cancer, gastric cancer (including stomach and GEJ), esophageal cancer, hepatocellular carcinoma, melanoma (uveal melanoma excluded), Merkel cell carcinoma, mesothelioma, MSI-high colorectal cancer, NSCLC, ovarian cancer, SCCHN, SCLC, RCC, triple-negative breast cancer, and urothelial carcinoma, or alternative immunogenic tumor types with medical monitor approval. Participants with DLBCL may participate in Part 2 of the study.
* Presence of measureable disease based on RECIST v1.1 for solid tumors or the Lugano classification for DLBCL.
* Willingness and ability to safely undergo pretreatment and on-treatment tumor biopsies.
* Eastern Cooperative Oncology Group performance status 0 or 1.

Exclusion Criteria:

* Laboratory and medical history parameters outside the protocol-defined range.
* Transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 14 days before study Day 1.
* Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
* Receipt of a live vaccine within 30 days of planned start of study drug.
* Active autoimmune disease that required systemic treatment in the past.
* Known active CNS metastases and/or carcinomatous meningitis.
* Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry. See protocol-defined exceptions.
* Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.
* Active infection requiring systemic therapy.
* Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
* Known history of HIV (HIV 1/2 antibodies).
* Prior treatment with an anti-LAG-3 antibody for any indication.
Evaluation Of The GE Monitor Product Line

This investigation is a multi-center study that will demonstrate that the GE Monitor meets equivalency and/or accuracy and/or performance criteria. This investigation will compare the test device(s) to itself, or one of the reference parameters, or a combination of parameters, including NIBP, temperature, SpO2, respirations, and ECG.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent from subject and/or guardian
* Ability to maintain proper placement of cuff and/or probe and/or sensor
* Presence of atrial fibrillation or other irregular heart rhythm (when applicable)
* Ability to single or dual monitor NIBP, ECG, and/or SpO2, whether or not already being monitored for any or all of these parameters (SuperSTAT development study only)

Exclusion Criteria:

* Any subject deemed too unstable, by clinician's discretion, or for another reason deemed unacceptable for study by the clinician
* Known dysrhythmias (when applicable)
* Known disease state or medical condition that A) compromises circulation to the extremity, B) compromises musculo-skeletal integrity, or C) otherwise contraindicates use of a NIBP cuff and/or SpO2 sensor on an extremity or ECG patches on skin
* Vigorous exercise prior to participating in the study
* Excessive movement or excitability causing false values or no determinations
* Known allergy to latex when latex products will be in contact with subject
* Subjects who have eaten, drank, smoked or chewed gum in the preceding half hour (temperature parameter only)
* Nasal/septal defects, cold and/or allergies that would not allow the subject to breathe through their nose (temperature parameter only)
* Subjects with whom flammable anesthetics will be used.
* Adult/pediatric subjects,(greater than 1 year of age) who, at the clinician's discretion, could not tolerate approximately 12, but no more than 25 blood pressures on each extremity
* Pediatric/neonatal subjects,(less than 1 year of age) who, at the clinician's discretion, could not tolerate approximately 10, but no more than 12 blood pressures on each extremity
* Presence of pacemaker which makes the atrial fibrillation rhythm indistinguishable
* Subject's limb circumference is outside of the manufacturer's recommended cuff range
* Subject has Korotkoff sounds that persist to nearly zero (when applicable)
A Study on the Use of CorMatrix® ECM® for Femoral Arterial Reconstruction

To gather information on the use of CorMatrix ECM for Vascular Repair in the reconstruction of the femoral artery.

OBJECTIVE The objective of the study is to actively gather additional information on the use of CorMatrix ECM for vascular repair in the reconstruction of the femoral artery. The CorMatrix ECM for Vascular Repair may be used for patch closure of vessels, as a pledget, or for suture line buttressing when repairing peripheral vessels.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be undergoing femoral arterial reconstruction with patch angioplasty closure
2. Surgeon intends to use CorMatrix ECM per FDA cleared Indications for Use
3. Subject possesses ability to provide informed consent
4. Subject expresses understanding and willingness to fulfill all expected requirements of protocol

Exclusion Criteria:

1. Known sensitivity to porcine material
Study to Assess Safety and Pharmacokinetics of Double-Blind S-707106 Alone and in Combination With Open-Label Metformin in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to determine the safety and pharmacokinetics of double-blind S-707106 alone and in combination with open-label metformin in patients with type 2 diabetes mellitus

Safety will be evaluated by monitoring of treatment-emergent adverse events, clinical laboratory evaluations, vital signs, 12-lead electrocardiograms, 24-hour telemetry monitoring, and physical exams. Specific study withdrawal criteria during washout periods of metformin have been established for loss of glycemic control, i.e., glucose monitoring. Pharmacokinetic assessments of monotherapy cohort versus add-on therapy will be performed

Eligibility Criteria:
Inclusion Criteria:

* Body mass index range (25.0-38 kg/m2) with type 2 diabetes mellitus receiving stable dose of metformin BID for the previous 60 days for glucose control
* Patients sterile or agree to use approved method of contraception
* No clinically significant abnormal tests
* Hemoglobin A1c level ≤10.5%

Exclusion Criteria:

* History of clinical manifestations of significant metabolic, hepatic, renal, and hematological pulmonary, cardiovascular, gastrointestinal, urological, neurological, or psychiatric disorders other than type 2 diabetes mellitus
* Uncontrolled diabetes
* Exclusionary labs - fasting blood sugar, low hemoglobin, elevated liver function tests, positive result for human immunodeficiency virus, hepatitis B surface antigen, and anti-hepatitis C virus
* Low creatinine clearance
* History of myocardial infarction within past 90 days or other cardiovascular conditions
* Prior exposure to S-707106
* Treatment with investigational study drug within 30 days of study admission day
Clinical and Radiological Outcomes of Medacta Shoulder System (BE)

This is a post-market surveillance study on Medacta Shoulder System


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Patient with one of the following diagnosis:

  1. Primary osteoarthritis
  2. Secondary osteoarthritis
  3. Cuff tear arthropathy; insufficient rotator cuff
  4. Acute fracture (\<21d)
  5. Rheumatoid or inflammatory arthritis
  6. Avascular necrosis
  7. Other posttraumatic condition
  8. Revision of shoulder arthroplasty

Exclusion Criteria:

* Patients with malignant diseases (at the time of surgery)
* Patients with proven or suspect infections (at the time of surgery)
* Patients with functional deficits other than dysfunction of the shoulder (at the time of surgery)
* Patients with known incompatibility or allergy to products materials (at the time of surgery)
A Drug Interaction Study of Lanabecestat (LY3314814) and Warfarin in Healthy Participants

The purpose of this study is to look at how much warfarin gets into the blood stream and how long it takes the body to get rid of it when given both with and without lanabecestat. Another purpose is to evaluate the effectiveness of warfarin therapy to prevent blood clots when given with lanabecestat by measuring international normalized ratio (INR). INR measures the time it takes for blood to clot and compares it to an average. Information about any side effects that may occur will also be collected. The study will last about 5 weeks from the first dose to follow-up for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Male participants: will be sterile (including vasectomy) or agree to use an effective method of birth control and will not donate sperm during the study and for 3 months following the last dose of the investigational product
* Female participants: women not of childbearing potential

Exclusion Criteria:

* Have a history of or current, significant ophthalmic disease, as determined by the investigator or ophthalmologist
* Have vitiligo or any other clinically significant disorder of skin pigmentation as determined by the investigator or dermatologist
* Have a history or presence of significant bleeding disorders
* Have a history of gastrointestinal ulcers with hemorrhage
* Have a personal or family history of coagulation or bleeding disorders or reasonable suspicion of vascular malformations
* Self-reported history of increased bleeding from trauma
* Have a history of major head trauma (with loss of consciousness) within the past year or minor head trauma (without loss of consciousness) within the last 3 months prior to screening
* History of major surgery within 3 months of screening
* Planned surgery within 14 days after the last day of dosing
* International Normalized Ratio (INR)/ Prothrombin Time (PT) or activated partial thromboplastin time above the normal reference range at screening
* Abnormal Protein S antigen and/or Protein C activity as determined by the investigator
* History of deep vein thrombosis and/or pulmonary embolism
Air Optix Daily Wear Contact Lenses

The purpose of this Post-Market Clinical Follow-Up (PMCF) study is to assess long term performance and safety of Air Optix Aqua, Air Optix plus HydraGlyde Sphere, and Air Optix plus HydraGlyde Toric soft contact lenses in a real-world setting when worn as daily wear.

This is a non-interventional/observational study designed as a retrospective chart review. Study sites will identify charts within their existing databases in a fair and consistent manner, e.g., reviewing all eligible charts in reverse chronological order by year of baseline visit. The baseline visit will be defined as the first office visit where an eye care practitioner provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for the study or comparator contact lenses was released. Subjects meeting the eligibility criteria will be enrolled in the study.

Eligibility Criteria:
Key Inclusion Criteria:

* Manifest refraction cylinder less than or equal to 0.75 diopter (D) in each eye at baseline (sphere wearers only);
* Best corrected visual acuity (BCVA) of 20/25 Snellen or better in each eye at baseline;
* Must have worn or be wearing Air Optix Aqua Sphere, Air Optix plus HydraGlyde Sphere, Air Optix plus HydraGlyde Toric, Biofinity Sphere or Biofinity Toric for at least 1 year in a daily wear modality, as determined by the Investigator;
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Have worn or be wearing Air Optix Aqua Sphere, Air Optix plus HydraGlyde Sphere, Air Optix plus HydraGlyde Toric, Biofinity Sphere, or Biofinity Toric contact lenses in an extended wear modality;
* Any recurrent history or active anterior segment infection, inflammation or abnormality contraindicating regular contact lens wear at baseline;
* Use of systemic or ocular medications contraindicating regular contact lens wear at baseline and/or during the period of the retrospective chart collection;
* Slit lamp findings, including signs of pathological dry eye, that would contraindicate regular contact lens wear;
* Other protocol-defined exclusion criteria may apply.