cyrilzakka/clinical-trials huggingface dataset:
Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination

The overall goal of this research study is to test the effectiveness of a multifaceted and multi-level prompting intervention in a real world urban primary care office setting on improving provider-delivered guideline-based asthma care and reducing asthma morbidity among urban children with persistent or uncontrolled asthma.

Investigators will conduct a cluster randomized trial comparing the intervention to enhanced usual care (eUC) in 20 Bronx practices serving over 5,000 children ages 2-12 years with persistent or uncontrolled asthma. Eleven eUC practices will receive guideline information and assess children's asthma severity and control, but active intervention components will not be provided. Practices will join the study in 4 waves over 4 years (4-6 practices per year). Provider adoption of guidelines and utilization of care in all patients (\~5,000) ages 2-12 years with persistent or uncontrolled asthma from intervention and eUC practices will be evaluated using Electronic Health Records (EHR) data and practice-based screening for asthma severity and control. Investigators will also enroll a random subset of 512 caregivers of children with persistent/uncontrolled asthma from both study arms to systematically evaluate caregiver-reported child morbidity outcomes and obtain measures not available in EHR.

Intervention consists of academic detailing in the EHR that follow national asthma guidelines and outreach worker care coordination for patients with persistent or uncontrolled asthma.

Eligibility Criteria:
Inclusion Criteria:

The criteria listed below will apply to \~5,000 children from eMPI and eUC practices:

* Physician-diagnosed asthma (based on EHR).
* Persistent or uncontrolled asthma as per clinic assessment. Based on NHLBI guidelines, any one of the following: in past month, \> 2 days/week with asthma symptoms, \>2 days/week with rescue medication use, \>2 days/month with nighttime symptoms, or \> 2 episodes in the past year that required systemic corticosteroids.
* Age 2 and 12 years, inclusive.

Additional inclusion criteria will apply to a subset of 512 of children whose caregivers will be interviewed to obtain caregiver-reported morbidity outcomes:

* Caregiver is able to speak and understand either English or Spanish. Participants unable to read will be eligible as all surveys will be administered verbally by research personnel.
* Consent from the primary caregiver, caregiver permission for the child to participate as well as assent from the child (\>7 years). If there are eligible siblings, only one child will be randomly selected.

Exclusion Criteria:

* The child has other significant medical conditions, such as congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures.

Additional exclusion criteria will apply to a subset of 512 children/caregivers as described above:

* No access to a telephone to conduct follow-up surveys.
* Children in foster care or other situations in which consent cannot be obtained from a guardian.
Evaluation of 8.5 vs 9.0 Base Curve for 1-DAY ACUVUE(r) TruEye(r) Brand Contact Lenses

The objective of this study is to determine if corneal diameter and keratometry readings correlate to subjective comfort and lens fitting characteristics.


Eligibility Criteria:
Inclusion Criteria:

* The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
* The subject must be no less than 18 and no more than 45 years of age with no presbyopic add.
* The subject must be willing and able to adhere to the instructions set out in the protocol.
* The subject must be an adapted soft contact lens wearer in both eyes.
* The subject must be willing to wear the study contact lenses up to 14 hours/day.
* The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 Diopters (D) to -6.00 D in each eye.
* The subject must have refractive cylinder less than or equal to 1.00 D in each eye.
* The subject must have best corrected visual acuity of 20/30 (6/9) or better in each eye.
* The subject must require a visual correction in both eyes (no monofit or monovision allowed).
* The subject must have normal eyes (i.e., no ocular medications or infections of any type).

Exclusion Criteria:

* Current 1-DAY ACUVUE® TruEye® wearers
* Anisometropia of 1.00 D or greater
* Any Ocular or systemic allergies or diseases which might interfere with contact lens wear.
* Any Systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear.
* Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
* Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
* Any ocular infection
* Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear
* Pregnancy or lactation
* Diabetes
* Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
* Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
Rotavirus Efficacy and Safety Trial (REST)(V260-006)

This study was designed to evaluate the safety of the investigational rotavirus vaccine and the efficacy to prevent rotavirus gastroenteritis.


Eligibility Criteria:
Inclusion Criteria:

* Healthy infants

Exclusion Criteria:

* None Specified
Non-Luer Butterfly Needle With One-way Valve for the Epidural Blood Patch: Does it Alter Blood Clotting?

The Department of Health recommends using equipment which prevents wrong route drug administration. However, the epidural blood patch requires equipment that connects to the intravenous and epidural route. To comply with these recommendations a non-Luer butterfly needle with one-way valve has been produced. The one-way valve and length of tubing has the potential to activate the clotting cascade. This could reduce the time clinicians have to utilise the blood in the syringe. Also any alteration in clotting could affect the therapeutic value of the epidural blood patch. The primary objective of this research was to determine if phlebotomy using this new 21G needle altered blood clotting, determined by thromboelastograph analysis, compared to a standard 21G hypodermic needle.

Ethical approval was gained from the Health Research Authority (North West - Greater Manchester South Research Ethics Committee, REC Reference Number: 16/NW/0570). After informed consent, we enrolled participants

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female.
* Aged 18 years or above.
* Within first 2 days postnatal for postnatal group
* Healthy participants must be in good health.
* Able (in the Investigators opinion) and willing to comply with all study requirements.
* Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.

Exclusion Criteria:

* Any medical condition
* In postnatal group, women with haemorrhage greater than 1L
* In postnatal group, less than 12 hours post prophylactic dalteparin
* Any clotting abnormality
* On any medication including herbal medication (vitamins taken during pregnancy are acceptable)
* Age less than 18 years at recruitment
* Adults who are not capable of giving valid consent
* Adults with learning disabilities/ difficulties
* Adults in emergency situations
* Unable to speak or read English
* Prisoners
* Adults unable to consent for themselves
* Any person considered to have a particularly dependent relationship with investigators
* Any others deemed to belong to a vulnerable group.
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
* Participants who have participated in another research study involving an investigational product in the past 12 weeks
A1c Discordance in Diabetes Patients

HbA1c is used as a gold standard to see whether patients have optimal glycemic control. Today, many physicians rely solely on HbA1c to change medication. However, there is a select group of patients that have low average glucose levels but high HbA1c levels. The investigators believe that these patients are fast glycators meaning that they incorporate sugar into their hemoglobin faster than normal. The investigators want to determine whether these patients are fast glycators.


Eligibility Criteria:
Inclusion Criteria:

* Patient with diabetes
* Patients who test their sugar levels at least 3 times daily
* Recorded diary of sugar levels for the past month
* Willingness to have blood drawn
* Willingness to allow their blood sugar diary to be photocopied
* Estimated average glucose as derived from A1c is ≥ 4 mmol from measured glucose from self-monitoring blood glucose testing

Exclusion Criteria:

* Patient with medical conditions that may affect their study participation or results will be excluded.
* Patients who are anemic
* Renal insufficient with a serum creatinine level \> 200 μmol/L
Intensive Combination Approach to Rollback the Epidemic in Nigerian Adolescents: UH3 Phase

Combination interventions with mHealth and Peer Navigation components will be evaluated in a randomized, stepped wedge trial among youth in Ibadan, Lagos, Sagamu, and Jos, Nigeria. Study findings will demonstrate whether or not the combination interventions for HIV testing and linkage to care and for HIV treatment outcomes, which were found to be efficacious in our prior pilot UG3 trial, will remain efficacious if scaled as proposed in this UH3 trial, across multiple sites.

A randomized stepped wedge (cluster) trial will be conducted to investigate two combination interventions (each with mHealth + Peer Navigation components) among youth in Ibadan, Lagos, Sagamu, and Jos, Nigeria. Study 1 (Testing and Linkage to Care) will test a combination intervention that targets HIV testing and linkage to care. Study 2 (Treatment Intervention) will test a combination intervention that targets HIV treatment outcomes (retention, adherence and viral suppression).

Eligibility Criteria:
Inclusion Criteria:

* Living with HIV infection
* Registered in the study clinics or their satellite clinics
* On antiretroviral therapy (ART) for at least 3 months
* Intention to remain a study clinic patient during the study observation and intervention period

Exclusion Criteria:

* Inability to provide informed consent
* Youths who are 15 years old and not emancipated, who do not have parental consent
Clinical Performance Evaluation of 3D Ear Canal Scanning Technology

Study participants will undergo ear canal impressions in a standard of care protocol utilizing two methodologies: 3D ear scanning using a commercially-available ear scanning device, and conventional silicone impression material. The elapsed time of each procedure will be captured for each participant, and the average duration of the two methodologies will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Hearing impairment (any degree, type, and configuration)

Exclusion Criteria:

* Absent or abnormal external auditory canal and/or external auditory meatus.
* Positive history of external/middle ear surgery.
Effect of the Food Supplement TOTUM-070 on Lipid Metabolism

This clinical trial is to confirm the effects of TOTUM-070, a mix of 5 plants extracts, consumed at the daily regimen of two times per day, on fasting blood LDL cholesterol concentrations in moderately hypercholesterolemic subjects after 12 weeks of consumption (V3).

The main objective is to confirm the efficacy of a 4.995g/day dose of TOTUM-070 versus placebo on fasting blood LDL cholesterol level (Ultracentrifugation (UC) method) in moderately hypercholesterolemic subjects following 12 weeks of consumption (V3).

The proposed double-blinded, placebo-controlled, clinical study will provide further insight into the safety and efficacy of TOTUM-070 at the same dose (4.995g/day) on a shorter supplementation period (3 months) than the previous one (6 months), as well as assess the effect after the follow-up period without product intake.

Eligibility Criteria:
Main Inclusion Criteria:

* I1. From 18 to 70 years (including ranges);
* I2. BMI of ≥18.5 and ≤35 kg/m²;
* I3. Moderately hypercholesterolemic subject without any clinical symptoms of hypercholesterolemia (xanthoma, recurrent chest and/or leg pain...) and not requiring immediate pharmacological lipid-lowering treatment;
* I4. Weight stable within ± 5% in the last three months before V0;
* I5. SCORE2 - SCORE2-OP (Older Persons) Cardiovascular Risk Chart

Main Exclusion Criteria:

* E1. Suffering from a metabolic disorder such as diabetes, uncontrolled thyroidal dysfunction or other metabolic disorder needing a dose adjustment in drug intervention according to the professional recommendations;
* E2. Suffering from an uncontrolled arterial hypertension;
* E3. With a history of ischemic cardiovascular event;
* E4. Having undergone recent surgical procedure in the past 6 months before V0 or planned in the 5 months to come;
* E5. History of bariatric surgery;
* E6. Suffering from a severe chronic disease;
* E7. For women: ongoing pregnancy (as evidenced by a positive test for β-Human Chorionic Gonadotropin, i.e. \> 5 mUI/mL, realized at V0) or breastfeeding or finished since less than 6 months before V0 or intending to become pregnant within 5 months ahead;
* E8. Under cholesterol and/or lipid-lowering treatment or stopped less than 3 months before the inclusion visit V0;
* E9. Under medication which could affect blood lipid parameters or stopped less than 3 months before the inclusion visit V0 (antihypertensive stable long-term treatment tolerated);
* E10. Consuming more than 3 standard drinks daily of alcoholic beverage for men or 2 standard drinks daily for women
Evaluation of Pancreatic Pseudocyst Drainage With a Metal Stent

The purpose of this study is to study the evaluation of the effectiveness of endoscopic Pancreatic Pseudocyst drainage using a metal stent.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is 18 years or older
2. Subject has pancreatic pseudocyst
3. Subject has medical indication for drainage of the pancreatic pseudocyst
4. Subject must be able to give informed consent

Exclusion Criteria:

1. Any contraindication to endoscopic pseudocyst drainage
2. Subject is unable to give informed consent
International Multisite Transcatheter Tricuspid Valve Therapies Registry

For a long time, tricuspid valve disease has been considered as less important than left-sided valvular heart disease. If treated in an advanced stage and simultaneously with other cardiac diseases, it is associated with significant morbidity and mortality. Hence, physicians tend to refer patients more aggressively to surgery (1).

Transcatheter procedures are an attractive alternative in high-risk patients. The field of transcatheter tricuspid devices has rapidly advanced over the last few years (2). Limited knowledge is available regarding the epidemiologic and anatomical settings in which these therapies are preferentially applied.

The main purpose of this registry is the collection of baseline clinical and anatomical data of the patients treated with transcatheter tricuspid valve therapies, and their outcomes, whenever feasible. Apart from more knowledge regarding the current status in this field, the results could also help the establishment of guidelines with respect to the choice of the transcatheter device selected and to understand which therapy can provide the better outcome in the different anatomies. Moreover, this study will provide important information about the epidemiology of severe tricuspid regurgitation, which is at the moment an undertreated disease.


Eligibility Criteria:
Inclusion Criteria:

* All the patients undergoing transcatheter tricuspid valve intervention.

General inclusion criteria:

* Minimal age: 18 years
* Patient is able to give written informed consent to the procedure

Exclusion Criteria:

* Patients not fulfilling the indications for transcatheter tricuspid intervention
Use of Continuous Wound Infusion of Bupivacaine for Analgesia Following Axillary Clearance Surgery

Axillary clearance forms part of the surgical armamentarium for the treatment of breast cancer. Although the introduction of sentinel lymph node mapping and dissection has allowed for the decreased use of axillary clearance, it remains a frequently performed operation. Axillary clearance is associated with moderate postoperative pain.

We hypothesize that a continuous wound infusion of 0.2% Bupivacaine at 4ml/hr would provide superior analgesia, when compared to standard opioid-based analgesia, in patients undergoing axillary lymph node clearance surgery.

The study will take the form of a prospective randomised clinical trial. The following assessment tools will be used

* The visual analogue scale (VAS) consists of a 100 mm horizontal line with the two end points labelled "no pain" and "worst pain ever". Patients are asked to mark on the line a point that corresponds to the level of pain intensity they feel. The score is obtained by measuring the distance (mm) from the left end of the line.
* The short-form McGill Pain Questionnaire (SF-MPQ) consists of 15 representative words from the sensory and affective categories of the standard McGill Pain Questionnaire. It also includes the present pain intensity and a VAS to provide overall indices of pain intensity. It has been shown to be sensitive to clinical changes brought about by various interventions, postoperative analgesic drugs (6).
* The Pain Catastrophising Score (PCS) is a 13 item instrument which asks patient to reflect on past painful experiences, and to indicate the degree to which they experienced each of these 13 thoughts or feelings, on 5-point scales with the end points; 0 = not at all, 4 = all the time. The PCS yields a total score and three subscale scores assessing rumination, magnification and helplessness (7).
* The Hospital Anxiety and Depression Score (HADS) is a 14-item scale, which screens for these, the two most common disturbances encountered in a medical setting (8).

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing axillary clearance surgery
* ASA physical status I - III

Exclusion Criteria:

* Patient refusal
* Pre-existing pain conditions
* Regular use of opioid analgesia
* Pregnancy
* Severe cardiac, renal or hepatic disease
* Psychiatric illness precluding ability to give informed consent
* Intercurrent neurological disease
* Contraindications to bupivacaine or morphine use
Swallowing Evaluation in VF Immobility

Vocal fold immobility (VFI) often results in significant problems with dysphonia, dysphagia, and decreased cough strength. As one element of the dysphagia potentially associated with vocal fold immobility,

aspiration may create significant morbidity for these patients. An estimated 38% to 53% of patients with

untreated VFI have swallowing difficulties with aspiration.

Vocal fold immobility has important implication on the laryngeal airway protection during respiration,

phonation and swallowing. It is the most common neurological laryngeal disorder.

The immobility may be caused by neck and thoracic surgery. which can impair the innervation of the pharynx,

upper esophageal sphincter (U.E.S) and proximal esophagus but may also be due to malignancy,trauma,

Intracranial causes,or may be idiopathic

Besides the voice alteration, the lesion that causes of vocal fold immobility should also affect the pharyngeal phase of swallowing.

It was suggested that dysphagia in patient with vocal fold immobility has multifactor causes ; including limited airway protection and decrease laryngopharyngeal sensation based on the finding of the flexible endoscopy.

Another study revealed that pharyngeal phase abnormalities such as delayed initiation of swallowing, reduced laryngeal elevation, and reduced upper esophageal sphincter (UES) opening were found in video fluoroscopic swallowing studies (VFSS).

Several studies on the swallowing difficulties of patient with vocal fold immobility has been performed and reported that nearly 56% of these patients immobility have swallowing dysfunction.

Eligibility Criteria:
Inclusion Criteria:

1. Age:above 18.
2. Gender:both sexes will be included in the study.

Exclusion Criteria:

1. patients with structural abnormalities of oral cavity, pharynx or larynx.
2. previous vocal fold injection or voice therapy.
3. other causes of dysphagia: esophageal cancer or spasm , gastric cancer, cancer larynx,or radio therapy .
4. . Patients with history of heart burn , acid regurgitation ,
5. other neurological disease ,stroke, hypothyroidism or dyspnea.
Efficacy and Safety of Increased Dose of TA-650(Infliximab) in Patients With Rheumatoid Arthritis

The purpose of this study is to assess the efficacy, safety and pharmacokinetics of maintenance treatment with 3mg/kg, 6mg/kg or 10mg/kg of TA-650 in combination with methotrexate (MTX) after three infusions (weeks-0, 2, 6) of 3mg/kg in Rheumatoid Arthritis (RA) showing an insufficient response to MTX.


Eligibility Criteria:
Inclusion Criteria:

* Patients with active RA in spite of stable dose of MTX

Exclusion Criteria:

* Having received infliximab in the past
* Having a history of serious infection which caused hospitalization within 6 months before the registration
* Having an active tuberculosis
* Having a complication or a history of malignancy within 5 years before the registration