cyrilzakka/clinical-trials huggingface dataset:
To Evaluate the Efficacy and Safety in Patients With Primary Hypercholesterolemia

To Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia.

A Multi-center, Randomized, Double-blinded, Active-controlled, Factorial Design Phase 3 Clinical Trial

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary hypercholesterolemia

Exclusion Criteria:

* The subject not meet the specified LDL-C level
Factors Affecting Outcomes of Using Diode Laser Both 980 nm Wave Length and 450 Wavelength on Benign Laryngeal Lesions in Comparison to Traditional Cold Instrumentations as Regard Parameters of Laser Device, Nature of Lesion and Patient Factors

Studying the different Factors affecting the outcomes of using diode laser both 980 nm wave length and 450 wavelength on benign laryngeal lesions in comparison to traditional cold instrumentations


Eligibility Criteria:
Inclusion Criteria:

- All patients with benign laryngeal lesions

Exclusion Criteria:

* patients presenting with or have history of malignant laryngeal lesion
Vaccine Confidence Study Among Historically Marginalized Racial and Ethnic Groups

Achieving optimal vaccination rates is vital for protecting the health and well-being of all individuals. This specific study focuses on the MMR and RSV vaccines in pregnancy and early childhood, which have been shown to reduce RSV and MMR-related illnesses, hospitalizations, and deaths. Efforts to improve vaccination rates have not been equally effective across the entire population; this has resulted in poorer outcomes from interventions for certain populations who are vaccine-hesitant.

This study seeks to understand how to best increase vaccine confidence in marginalized populations. To do this, the investigators will interview parents of children who receive care at Boston Medical Center (BMC), Community Health Workers and other Clinical providers at BMC, leading experts in the fields of vaccine confidence and implementation science, and key public health stakeholders/officials.


Eligibility Criteria:
Inclusion Criteria:

Parent and child-

* The birthing parent of any age of a child (aged 12-24 months) who receives primary care at Boston Medical Center
* A birthing parent who is registered as a patient at Boston Medical Center
* The birthing parent must have been pregnant between the months of October and February (RSV season)
* The birthing parent must be comfortable completing an interview in English, Spanish, or Haitian Creole.

Clinician

* Clinical provider (including Community Health Workers, Physicians, Physician Assistants and Nurse Practitioners) aged 18+ years at Boston Medical Center within Pediatrics, Family Medicine, or OB/GYN. These clinicians will have been involved in past or current successful vaccine-specific Evidence Based Interventions (EBI) beyond BMC and its affiliated Community Health Center (CHC).

EBI Expert

* Content experts (aged 18+ years) in the areas of Implementation Science, Vaccine-specific EBIs, and Prenatal genetic counseling

Exclusion Criteria:

* Clinical provider (including Community Health Workers, Physicians, Physician Assistants and Nurse Practitioners) at NON-BMC clinic/Community Health Center
* Content experts - NON-Vaccine evidence based interventions (EBIs)
Yeast Mannans and Stool Frequency

Findings from an open-label pilot study of 20 adults suggested that supplementation with 15 g/day of yeast mannans was highly tolerable and demonstrated specific modulation of the microbiota and increased stool frequency in a subset of subjects reporting ≤1 stool per day at baseline. The primary aim of this randomized, double-blind, controlled trial is to determine if yeast mannan supplementation at 12 g/day will increase stool frequency in generally healthy adults reporting ≤1 stool per day. Secondary aims will determine the effect of yeast mannans on intestinal transit time, gastrointestinal symptoms, fecal microbiota composition, and urinary and fecal metabolomics.


Eligibility Criteria:
Inclusion Criteria:

* Adults who report a stool frequency of ≤ 1 per day.
* Able to provide written informed consent in English.
* Willingness to consume 1 supplement (12 g of yeast mannans or control) daily for 28 days.
* Willingness to maintain their usual diet and physical activity patterns throughout the study and refrain from the consumption of any yeast-based foods (e.g. Marmite or Vegemite) or yeast extract supplements.
* Willing to comply with study procedures, including stool and urine colle

Exclusion Criteria:

* Stool frequency of \< 3 per week
* Yeast allergy
* Vegan dietary pattern
* Self-reported kidney disease
* Elite athletes or long-distance runners
* Use of antibiotic drugs within 1 month of screening
* Current use of laxatives or antidiarrheal medications
* Use of other investigational products within 3 months of the screening
* Previously or currently being treated for intestinal diseases or conditions, including irritable bowel disease (i.e., IBS-D or IBS-mixed), Crohn's disease, ulcerative colitis, celiac disease, or gastrointestinal cancer.
* Previous gastrointestinal surgery (e.g., gastric bypass, fundoplication, bowel resection).
* Current cancer treatment.
* Currently pregnant.
Ex-vivo Adhesion of Bacteria to Different Contact Lens Materials

This is a single-site, 4-visit, contralateral, dispensing, open-label, randomized study. Each eligible subject will be randomized into one of two sequence groups to wear two lens types contralaterally (Test on the right eye and Control on left eye or vice versa).


Eligibility Criteria:
Inclusion Criteria:

* Potential subjects must satisfy all of the following criteria to be enrolled in the study.

  1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. Between 18 and 45 (inclusive) years of age at the time of screening.
  4. Be a current spherical soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week wear time over the last 30 days by self-report.
  5. Have a pair of spectacles with corrected vision of 20/40 or better in each eye or uncorrected vision is 20/40 or better in each eye
  6. The subject's vertex-corrected spherical equivalent distance refraction must be in the range of -1.00 through -6.00 D in each eye.
  7. The subject has a best-corrected visual acuity of 20/25 or better in each eye.

     Exclusion Criteria:
* Potential subjects who meet any of the following criteria will be excluded from participating in the study.

  1. Currently pregnant or breastfeeding.
  2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
  3. Any autoimmune disease or use of medication, which may interfere with contact lens wear. Habitual medications used by successful soft contact lens wearers are considered acceptable.
  4. Any ocular abnormalities such as entropion, ectropion, extrusions, chalazia, recurrent styes, history of recurrent corneal erosions.
  5. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
  6. Multifocal, toric or extended wear contact lens correction.
  7. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
  8. History of binocular vision abnormality or strabismus.
  9. Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.
  10. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
  11. Any ocular infection.
  12. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the EFRON scale (Appendix G), any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
  13. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
Single Oral Dose of Dexamethasone Versus Five Days of Prednisone in Adult Asthma

This study seeks to compare the effectiveness of a single dose of oral dexamethasone versus 5 days of oral prednisone in the treatment of mild to moderate asthma exacerbations to prevent relapse with an unscheduled return visit to a health care provider for additional asthma treatment within 14 days. The investigators hypothesize that the two treatments will be equally effective in relapse prevention.

Dexamethasone and Prednisone are both systemic corticosteroids. The study will compare a single dose of oral dexamethasone to 5 days of oral prednisone in the treatment of asthma. Oral corticosteroids are commonly prescribed following an asthma exacerbation as it has been demonstrated that these medications prevent relapse.

Oral prednisone is the most common corticosteroid prescribed for asthma relapse prevention. The half life is around 4 hours and is typically prescribed for minimally 5 days.

The study is evaluating the efficacy of a single dose of dexmethasone. The drug's efficicacy has been shown to be longer acting and up to 72 hours. A single dose would eliminate the need for a prescription for a drug like prednisone to hopefully improve compliance.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-55yo
* History of asthma
* Requires \> 1 albuterol nebulizer
* Valid phone number

Exclusion Criteria:

* declines participation
* Past allergic reaction to corticosteroids
* Use of Oral steroids in the last 2 weeks
* Pregnant
* History of COPD, pulmonary fibrosis, cystic fibrosis, or other chronic lung disease
* History of HIV
* History of CHF
* History of Diabetes mellitus
* Active chickenpox (varicella) or shingles (herpes zoster)
* Active TB
* Requires admission to the Hospital
* Requires immediate airway intervention
Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices

The primary objective of the study is to assess the chronic safety of MicroPort CRM market-released systems.

PIANO Post Market Surveillance (PMS) investigation will cover MicroPort CRM systems CE- market and released since 2018.

Continuous monitoring of MicroPort CRM market-released systems will also enable to:

* confirm the safety and performance of the device throughout the study duration
* identify previously unknown side-effects and monitoring the identified side-effects and contraindications,
* identify and analyse emergent risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio
* identify possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct

Eligibility Criteria:
Inclusion Criteria:

Subjects who meet all the following criteria at the time of the inclusion visit may be enrolled in the study:

1. Subject implanted with one of the following MicroPort CRM market-released system:

   * ENO, TEO, OTO, ALIZEA, BOREA, or CELEA PM single chamber (SR) or dual chamber (DR) implanted after 01 January 2020 in combination with at least one XFINE or VEGA pacing lead
   * ULYS, EDIS ICD single chamber (VR) or dual chamber (DR) system in combination with an INVICTA defibrillation lead. Additional XFINE or VEGA atrial pacing lead is optional.
   * GALI CRT-D implanted in combination with an INVICTA defibrillation lead. Additional NAVIGO left ventricular pacing lead is optional.
   * GALI SONR CRT-D in combination with an INVICTA defibrillation lead and with either a NAVIGO left ventricular or a SONRTIP atrial pacing lead.
   * Future generation of market approved MicroPort CRM PM, ICD or CRT-D device associated with existing or future generation of MicroPort CRM lead
2. Subject equipped with Remote Monitoring System (RMS) (only for subject implanted with ICD or CRT-D system)
3. Subject followed yearly per standard practice by investigational site: in-clinic visit or remote visit through remote monitoring system
4. Subject reviewed, signed and dated the Informed Consent Form (ICF) if applicable per country regulation

Exclusion Criteria:

Subjects who meet any of the following criteria are not eligible to be enrolled in the study:

1. Age less than 18 years old or more than 90 years at time of inclusion, incapacitated or under guardianship or kept in detention
2. Life expectancy less than 1 year
3. Currently enrolled in an active study of MicroPort CRM
The Incidence of Hepatitis B Reactivations in Patients Affected by Chronic Lymphocytic Leukemia With Ibrutinib

This observational retrospective study will enroll at least 158 patients affected by Chronic Lymphoid Leukemia (CLL) with previous HBV exposure (HBsAg negative, anti-HBc positive with or without anti-HBs) treated with Ibrutinib single agent according to the IWCLL criteria 2008. Patients will be divided into two cohorts, one encompassing patients who received lamivudine and the second one including patients who received no prophylaxis. Each patient will be observed for one year from the first administration of Ibrutinib.

This observational retrospective study will enroll at least 158 patients affected by CLL with previous HBV exposure (HBsAg negative, anti HBc positive with or without anti-HBs) treated with Ibrutinib single agent according to the IWCLL criteria 2008. Patients will be divided in two cohorts one encompassing patients receiving lamivudine and the second one including patients who will not be given any prophylaxis. Each patient will be observed for one year from the first administration of Ibrutinib.

The aim of the Study is to evaluate the incidence of HBV reactivation cases in patients affected by CLL treated with Ibrutinib.

Eligibility Criteria:
Inclusion Criteria:

* CLL/small lymphocytic lymphoma (SLL) patients.
* Patients treated with single-agent Ibrutinib (at least one dose) outside interventional clinical trials before January 31, 2019.
* Serology positive with previous HBV/OBI (HBsAg negatives, anti-HBc positives with or without anti-HBs) infection.
* Signed written informed consent, if applicable, indicating study scope and procedure understanding.

Exclusion Criteria:

* Patients who did not undergo hepatitis B screening before starting the Ibrutinib therapy.
* Patients affected by CLL treated with Ibrutinib vaccinated against hepatitis B or with serology not compatible with a previous infection.
* Patients affected by HCV, HIV or with other causes of liver disease.
* Patients enrolled in clinical trials including Ibrutinib administered in combination with other drugs.
* Patients positive for active hepatitis B.
Heavy Slow Resistance Training in Adults With Frozen Shoulder

The aim of the study is to evaluate the efficacy of Heavy Slow Resistance exercise in patients diagnosed with frozen shoulder using randomized controlled trial design


Eligibility Criteria:
Inclusion Criteria:

* Unilateral painful, restricted active and passive range of motion of the shoulder, with loss of passive external rotation of at least 50% compared to opposite side at 0 deg of abduction
* Symptoms present for at least 3 months
* Normal x-rays on anteroposterior, axillary and lateral views

Exclusion Criteria:

* Severe degeneration, or trauma involving the shoulder
* Inflammatory joint disease affecting the shoulder.
* Pain or disorders of the cervical spine, elbow, wrist, or hand
* Stroke or peripheral nerve neuropathy Injection with corticosteroids in the affected shoulder in the preceding 4 weeks.
Safety and Tolerability of 4975 in Patients Undergoing Arthroscopic Surgery to Repair the Rotator Cuff of the Shoulder

The purpose of this study is to evaluate the safety, tolerability and explore the efficacy of a single intraoperative injection of 4975 in patients undergoing arthroscopic surgery for rotator cuff repair of the shoulder

This is a multicenter, randomized, double-blind, placebo-controlled, two-stage exploratory study in patients undergoing arthroscopic rotator cuff repair surgery.

Stage 1) Patients will be randomized to receive either 4975 or placebo. The dose of 4975 will be escalated in a protocolized manner based on safety and tolerability.

Stage 2) Patients will be randomized in a 1:1 ratio to receive either the selected dose of 4975 or placebo. All patients will be observed in the hospital for at least two days following surgery for safety, tolerability, and efficacy assessments. In addition there will be two planned follow-up visits after hospital discharge.

Eligibility Criteria:
Key Inclusion Criteria:

* Male or female between the ages of 18 and 75 inclusive
* In overall good health and planning to undergo unilateral arthroscopic shoulder surgery to repair at least one rotator cuff tendon involving humeral attachment
* Willing and able to complete the study procedures, pain assessments, and medication diaries, and to communicate in Korean or English with study personnel

Key Exclusion Criteria:

* Shoulder surgery requiring concomitant repair of biceps muscle or associated tendon(s)
* Planning to undergo shoulder surgery on both shoulders
* Use of disallowed pain medications prior to the surgery
* Female patients who are pregnant or lactating or who plan to get pregnant
* Diabetes mellitus with a known HbA1C\>9.5
Use Of SB-705498 In The Acute Treatment Of Migraine

Despite the success of the triptan class of drugs, approximately 60% of patients who take medication at the moderate to severe pain stage of acute migraine, still have pain of mild or greater degree at 2 hrs post dose. SB-705498 is a novel, first in class TRPV1 receptor antagonist under development for the treatment of migraine pain. Preclinical experiments have demonstrated that the TRPV1 receptor is expressed both centrally and peripherally in the trigeminal system and inhibition of TRPV1 with SB-705498 can both prevent and reverse established central sensitisation.


Eligibility Criteria:
Inclusion criteria:

* Healthy subjects suffering from moderate to severe migraine headache with or without aura.
* Women of child bearing potential must use an effective method of contraception.
* Have had at least a 1 year history of migraine and the age of onset was prior to 50 years.
* Suffering 1 to 6 migraine attacks per month for at least the last 3 months and should have at least 48 hours free of headache between migraine attacks.

Exclusion criteria:

* Headache for 15 days/month or greater in any of the three months (90 days) preceding entry into the study.
* Use of migraine medications (e.g., ergotamine, triptan, opioid, or combination medication) on \>/= 10 days per month on a regular basis for \>/= 3 months.
* Use of analgesics \>/=15 days per month for \>/=3 months, uses an opiate (except codeine) as first line treatment for migraine.
* Migraine symptoms do not respond to any of the triptan drugs (e.g., Imitrex, Relpax, Maxalt).
* Have uncontrolled hypertension or a history/ presence of multiple cardiovascular risk factors such as, but not limited to family history, myocardial infarction, coronary artery disease, vasospastic angina, heart failure, cardiac arrhythmias or history or presence of cerebrovascular disease, including transient ischemic attack, stroke or peripheral arterial disease.
* History of alcohol, substance or drug abuse within the last year.
* Participation in a trial with a new chemical entity within 3 months before the start of the study.
* Participation in any other research trial within 30 days prior to the first dose of current study medication is not permitted.
Marinobufagenin as a Target for DIGIBIND in Hypertensive Patients With End-stage Renal Disease

The purpose of this study is to examine the effects of the digibind drug on hemodialysis patients with high blood pressure. Digibind is used to treat toxicity from digoxin and digoxin-like molecules which may contribute to high blood pressure.

High blood pressure is a very common problem in patients with kidney disease. Researchers have noted that there are certain molecules in the blood of these patients that may be contributing to the high blood pressure. In particular these molecules have been labeled as "digoxin-like substances." Digoxin is a drug made from a certain plant that may contribute to high blood pressure. In research animals with kidney failure, it has been noted that the use of Digibind helps to lower the blood pressure in these animals. Digibind is a drug made from sheep that is used to treat the toxicity from digoxin as well as toxicity from molecules similar to digoxin.

In this study, volunteers that are on hemodialysis and have high blood pressure will be given a placebo or the digibind drug intravenously on two separate visits. The volunteers will then wear a 24-hour blood pressure monitor and return the following day. Volunteers will receive the Digibind at one visit during the study, and the placebo on the other visit.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-75 years of age
* On hemodialysis with predialysis BP \> 150/90 but ≤ 180/110
* On at least one anti-hypertensive medication for 6 consecutive readings
* Able to have blood pressure measured in an arm
* Women of child bearing potential must not be pregnant; must use contraception during the study and for one month after the study
* Receiving adequate dialysis (KT/V \> 1.2)
* Compliant with the dialysis schedule and duration

Exclusion Criteria:

* Pregnant or nursing women
* Arm blood pressure is not possible to obtain
* Currently on digitalis
* On any Digibind-type product in the past
* History of allergies to antibiotics
* History of asthma
* Medical or psychiatric disorders which are unstable or which might interfere with study assessments or safe participation in the study
* History of use of, or evidence of need for, digitalis-like products
* Inability to understand or provide informed consent