cyrilzakka/clinical-trials huggingface dataset:
Er:YAG Laser and Air Polishing Application in Periodontal Treatment

Periodontitis (gum disease) is an infection of the gums that can lead to tooth loss. In recent years, many types of dental lasers or other devices have been used for the non-surgical treatment of periodontal diseases. However, it remains unclear whether the combined application of laser and air polishing is effective as an adjuvant treatment for periodontitis. The purpose of this study is to compare the use of combined application of Er:YAG laser and sub-gingival air polishing powder, with the treatment of Er:YAG laser only, in periodontal diseases treatment in a Chinese population.

The study will use a split-mouth design, two quadrants (one quadrant from each jaw) were randomly allocated to either the test or control group. The quadrants in the test group received Er:YAG laser (ERL) plus sub-gingival air polishing treatment, while the quadrants in the control group received ERL only. Clinical periodontal examinations were evaluated at baseline, 3 months, 6 months, 1 year, and 2 years.

Eligibility Criteria:
Inclusion Criteria:

* 1) aged 35-65 years old, in good systemic healthy;
* 2) clinically diagnosed with generalized stage Ⅱ or stage Ⅲ periodontitis;
* 3) a minimum of 20 teeth

Exclusion Criteria:

* 1) pregnancy or recent pregnancy plans;
* 2) had received periodontal treatment within the previous 6 months;
* 3) taken antibiotics within the previous 3 months;
* 4) had diabetes;
* 5) obvious malocclusion, history of orthodontic treatment, or a habit of mouth breathing.
HAIC Plus Lenvatinib vs HAIC Plus Sorafenib for Advanced HCC

The purpose of this study is to evaluate the efficacy and safety of sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) compared with lenvatinib combined with HAIC in patients with advanced hepatocellular carcinoma (HCC)


Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
* Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
* Barcelona clinic liver cancer-stage C
* Eastern Cooperative Oncology Group performance status of 0 to 2
* with no previous treatment
* No Cirrhosis or cirrhotic status of Child-Pugh class A only
* Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
* The following laboratory parameters:
* Platelet count ≥ 75,000/μL
* Hemoglobin ≥ 8.5 g/dL
* Total bilirubin ≤ 30mmol/L
* Serum albumin ≥ 30 g/L
* ASL and AST ≤ 5 x upper limit of normal
* Serum creatinine ≤ 1.5 x upper limit of normal
* INR ≤ 1.5 or PT/APTT within normal limits
* Absolute neutrophil count (ANC) \>1,500/mm3
* Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
* Known history of HIV
* History of organ allograft
* Known or suspected allergy to the investigational agents or any agent given in association with this trial.
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Evidence of bleeding diathesis.
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* Known central nervous system tumors including metastatic brain disease
A Study of MEDI7352 in Painful Osteoarthritis of the Knee

The purpose of this study is to assess the safety, drug levels and effects on the body of MEDI7352, in subjects with painful osteoarthritis of the knee.

An interleaved SAD/MAD Study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MEDI7352 in subjects with painful osteoarthritis of the knee.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects with painful osteoarthritis (OA) of the knee. Female subjects must be postmenopausal or surgically sterile.
* Body weight between 50kg and 145kg
* Willing and able to comply with the requirements of the protocol

Exclusion Criteria:

* Current treatment with another biologic therapeutic agent
* Current of historical diagnosis of RA
* Current diagnosis of an immunological condition that is associated with another form of arthritis in addition to OA, including traumatic arthritis or a seronegative spondyloarthropathy
* At risk of destructive arthropathy, including Rapidly Progressive Osteoarthritis (RPOA), osteonecrosis, spontaneous osteonecrosis of the knee, subchondral insufficiency fractures, hip dislocation and pathological fracture
* Presence of clinically significant neuropathy or other clinically significant disorder involving abnormal peripheral sensation.
* Current serious or unstable clinically important illness.
Safety and Tolerability of IBI355 in Healthy Volunteers

This study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of IBI355 in Healthy volunteers. This study also aims to evaluate the anti-Drug antibody after multiple ascending doses of IBI355 in Healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Understanding and Signing a written informed consent prior to selection;
2. Aged above 18 years old, male or female;
3. Body mass index (BMI) between 18-28kg/m2;
4. Normal label test;
5. No parenting plan for at least 6 months

Exclusion Criteria:

1. Subjects with a history of allergy；
2. Subjects participated in the other clinical trail in 1 month or less than 5 t1/2 since the previous clinical trial (which is longer)；
3. Subjects with an infection requiring systemic medication was present within 30 days prior to randomization;
4. HIV-Ab、RPR、HCV-Ab、HBV、HBeAg or HBcAb, one of them positive;
5. There have a clinical or imaging evidence that the subject with active tuberculosis, or there is evidence that the subject is in the incubation period for tuberculosis;
6. Patients with a history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders and other systemic diseases;
7. Subject with a hcg positive;
8. Patients with a history of neuropsychiatry or who are considered unfit to participate in this clinical trial
Sunphenon Epigallocatechin-gallate (EGCg) in Relapsing-remitting Multiple Sclerosis (SuniMS Study)

Hypothesis:

Sunphenon, a green tea extract containing 95% egcg, given daily as oral medication over a period of 18 months has anti-inflammatory and neuroprotective properties in patients with relapsing-remitting multiple sclerosis as assessed by magnetic resonance imaging and clinical examination (EDSS and MSFC).

This multicentric, national study investigates the efficacy and safety of EGCG in patients with relapsing-remitting multiple sclerosis.

Eligibility Criteria:
Inclusion Criteria:

* male and female subjects age 18 to 60
* relapsing-remitting course of MS
* stable treatment with glatiramer acetate at least 6 months prior to inclusion

Exclusion Criteria:

* primary or secondary progressive forms of MS
* clinically relevant heart, lung, liver, kidney diseases
* regular hepatotoxic co-medication
* drug addiction
* alcohol abuse
The Effect of Chiropractor-informed Triage on Low Back Pain Patient Outcomes and Trajectories

Almost everyone will have low back pain (LBP) at some point in their lives. LBP is a complex multifactorial condition for which diagnosis and clinical management remains a challenge. Factors such as wait times, delays in diagnosis or proper referral can result in Canadian patients having difficulty getting the care that they need. The overall objective of this project is to explore how chiropractors, who specialize in the diagnosis and clinical management of spinal conditions, can transform healthcare trajectories and improve the health of patients with LBP by integrating medical specialist team.To do so, patients with low back pain seeking medical care within the public health system will be first seen by chiropractors. Chiropractors will play a key role in identifying the type of low back pain and subsequently offering guidance to medical specialists with regard to the best treatment and management options that are currently recommended. Participating patients will be followed over a year while extensive health-related data will be collected and compared to non-triage patients with LBP.


Eligibility Criteria:
Inclusion Criteria:

* Being ≥ 18 years of age
* Being scheduled in the outpatient clinics with a primary complaint of LBP (either acute, chronic or recurring episodes), consistent with LBP definition (pain between the lower rib margins and the buttock creases, with or without associated symptoms in the lower limb(s)).
* Being able to comprehend and express oneself in French

Exclusion Criteria:

* Patients involved in litigation related to their LBP condition (i.e., worker's compensation, public automobile insurance plan or other litigations)
Clinical and Prognostic Value of Sarcopenia in Patients Older Than 70 Years With Diffuse Large B-cell Lymphoma

This clinical trial is a multicentric prospective study to assess the clinical and prognostic value of sarcopenia in patients older than 70 years with diffuse large B-cell lymphoma.

Sarcopenia status is assessed by CT scan imaging on the overall survival at 18 months in patients older than 70 years with diffuse large B-cell lymphoma treated by R-CHOP.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>= 70 years
* DLBCL, grade IIIB follicular lymphoma or histologically proven transformed low grade lymphoma
* Whatever the IPI score and the performance status
* Treated by Rituximab-CHOP or Rituximab-mini-CHOP
* CT scan imaging performed one month or less before inclusion
* Signed informed consent

Exclusion Criteria:

* No initial CT scan imaging performed more than one month before inclusion
* Positivity for HCV, HBV and HIV
* Anthracycline contra-indication
ActionHealthNYC Research Study

The ActionHealthNYC program is a year-long demonstration program to improve access to high quality health care for NYC resident immigrants who do not qualify for public insurance with incomes at or below 200% of the Federal Poverty Level (FPL). The purpose of this study is to determine whether improved access and care coordination services provided through the ActionHealth NYC program allows participants to have easier access to healthcare (particularly primary care and preventive services) than non-participants.

The ActionHealthNYC program is a year-long demonstration program to improve access to high quality health care for NYC resident immigrants who do not qualify for public insurance with incomes at or below 200% of the Federal Poverty Level (FPL). Our goal in piloting the program and conducting the research study is to understand the following questions:

* For clients participating in the ActionHealthNYC program, do they report having easier access to health care?
* What are the differences in health care utilization for participants in the ActionHealthNYC program and those not in the program?
* Do the participants in the ActionHealthNYC program report fewer barriers to needed care when compared to those not in the program?
* Are the participants in the ActionHealthNYC program more likely to have received preventive services according to the United States Preventive Services Task Force (USPTF) or recommended services for those with a qualifying condition through their medical home?
* How does the likelihood of receiving a new diagnosis compare between the ActionHealthNYC member group and the study group?
* How does emergency department and hospital use compare between the ActionHealthNYC member group and the study group?

We will be conducting a randomized controlled trial (RCT) where we will be enrolling 2,400 people that meet the eligibility criteria and randomizing half into the ActionHealth NYC program. We will be employing a mixed methods approach to address differences between participants randomized to receive enhanced services through ActionHealthNYC (AHNYC) and those receiving usual care, utilizing surveys, secondary data analysis, key informant interviews and participant focus groups.

Eligibility Criteria:
Inclusion Criteria:

* New York City residents who are uninsured, 19 and older and
* Not currently eligible for Medicaid, Essential Plan, or
* Not currently eligible for private insurance via federal insurance marketplace subsidies due to their immigration status.

Exclusion Criteria:

* Not a New York City resident
* Currently eligible for Medicaid, Essential Plan or private insurance at state exchange with federal subsidies
* Income above 200% of the federal poverty level (FPL)

Enrollees are required to have the NYC Municipal identification card (IDNYC). If they do not have the card, however, they can obtain it and come back for enrollment.
Pharmacokinetics, Safety, and Efficacy of Intravenous Dosing of Buprenorphine in Pediatric Patients Who Require Opioid Analgesia for Acute Moderate to Severe Pain

The purpose of this study is to characterize the safety, pharmacokinetics (PK), and efficacy of intravenous (IV) buprenorphine in pediatric patients.

A study of the PK, safety, and efficacy of IV buprenorphine in acute moderate to severe pain in male and female pediatric patients aged from birth to 6 years, inclusive, requiring continuous opioid analgesic treatment for at least 24 hours and up to 72 hours.

Eligibility Criteria:
Inclusion Criteria include:

* Must have written informed consent provided by the parent or legal guardian and/or patient assent, when appropriate
* Male and female children, from birth to aged 6 years, inclusive, with minimum weight of 2.5 kg
* Have or are anticipated to have acute moderate to severe pain; requiring treatment with an intravenous (IV) opioid analgesic medication for at least 24 hours postoperatively or; due to prolonged endotracheal intubation requiring IV opioid analgesic treatment for at least 24 hours poststabilization
* Must have stable vital signs
* Must have stable respiratory status
* Must be inpatient for the treatment period of the study

Exclusion Criteria include:

* Have any known allergy or sensitivity to buprenorphine or other opioids (this criterion does not include patients who have experienced common opioid side effects \[eg, nausea, constipation\])
* Have evidence of impaired renal function
* Have hepatic impairment
* Have history of seizures
* Have a history of sleep apnea within the past year
* Have structural heart disease or a pacemaker
* Have clinically unstable cardiac disease
* Have used any investigational medication/therapy within 30 days prior to the first dose of study drug
* Are deemed to be unsuitable by the investigator for reason(s) not specifically stated in the exclusion criteria.

Other protocol-specific inclusion/exclusion criteria may apply.
Clinical Trial to Evaluate CERC-002 in Adults With COVID-19 Pneumonia and Acute Lung Injury

The study is a prospective, randomized, placebo-controlled, double-blind phase 2 clinical study of the efficacy and safety of CERC-002, a potent inhibitor of LIGHT (Lymphotoxin-like, exhibits Inducible expression, and competes with Herpes Virus Glycoprotein D for Herpesvirus Entry Mediator, a receptor expressed by T lymphocytes), for the treatment of patients with 2019 novel coronavirus disease (COVID-19) pneumonia who have mild to moderate Acute Respiratory Distress Syndrome (ARDS).

LIGHT is a cytokine in the tumor necrosis factor super family (TNFSF14) which drives inflammation and induces many other cytokines including IL-1, IL-6 and GM-CSF. LIGHT levels have been shown to be elevated in COVID-19 infected patients and inhibiting LIGHT is hypothesized to ameliorate the cytokine storm which has shown to be a major factor in progression of ARDS.

The study will assess the efficacy and safety of CERC-002 in patients with severe COVID-19 over a 28 day period as single dose on top of standard of care.


Eligibility Criteria:
Inclusion Criteria:

1. Subject/legally authorized representative (LAR) is able to understand and provide written informed consent, and assent (as applicable) to participate in this study.
2. Subject is ≥18 years of age at the time of informed consent and assent (as applicable).
3. Subject is male or non-pregnant, non-lactating female, who if of childbearing potential agrees to comply with any applicable contraceptive requirements if. discharged from the hospital prior to completing the study.
4. Subject has a diagnosis of COVID-19 infection through an approved testing method.
5. Subject has been hospitalized due to clinical diagnosis of pneumonia with acute lung injury defined as diffuse bilateral radiographic infiltrates with partial pressure of arterial oxygen/percentage of inspired oxygen (PaO2/FiO2) \>100 and \<300.
6. Subject's oxygen saturation at rest in ambient air \<93%

Exclusion Criteria:

1. Subject is intubated.
2. Subject is currently taking immunomodulators or anti-rejection drugs.
3. Subject has been administered an immunomodulating biologic drug within 60 days of baseline.
4. Subject is in septic shock defined as persistent hypotension requiring vasopressors to maintain mean arterial pressure (MAP) of 65 mm Hg or higher and a serum lactate level greater than 2 mmol/L (18 mg/dL) despite adequate volume resuscitation.
5. Subject has received any live attenuated vaccine, such as varicella-zoster, oral polio, or rubella, within 3 months prior to the baseline visit.
Screening MRI for Cancer Recurrence in Patients Treated With Breast Conserving Therapy

A prospective, multicenter study:

* Primary objective: to assess the diagnostic yield of screening MRI compared to physical examination, mammography or ultrasonography in the detection of recurrence in patients treated with breast conserving therapy
* Secondary objective: to describe the size, type, grade, and nodal status of cancers seen only on MRI and to estimate the rate of benign biopsies and short interval follow-up induced only by MRI in this population.

* Patients treated with breast conserving therapy will be followed for recurrence in the ipsilateral or contralateral breast by physical examination every six month and imaging studies performed annually.
* The imaging including mammography, physician-performed bilateral whole breast ultrasonography and a dynamic breast MRI with gadolinium-containing contrast medium will be performed according to a standard protocol. Interpretation will be conducted independently and classified according to the Breast Imaging Reporting and Data System (BI-RADS) by experienced radiologists.
* Definitive information about the presence of malignancy will be obtained by biopsy directed by the imaging method best depicting the lesion with 14-g or 11-g needle devices or needle localized excision. The absence of breast cancer was determined by means of biopsy, the absence of positive findings on repeat imaging and clinical examination, or both at follow-up.
* After three rounds of annual screening, the diagnostic yield of screening MRI compared to physical examination, mammography or ultrasonography will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Women ≥ 20 years in age;
* Women who underwent breast-conserving surgery for invasive breast cancer, whose final margins were negative and who finished radiation therapy at least 6 months prior to this study;
* No history of breast biopsy of the breast within 6 months prior to this study;
* Signed study-specific informed consent prior to registration;
* Has not had contralateral mastectomy;
* No known metastatic disease;
* Not pregnant or lactating;
* No present signs or symptoms of breast cancer \[no palpable mass(es), bloody or spontaneous clear nipple discharge, axillary mass, or abnormal skin changes in the breast(s) or nipple(s)\].
* No contraindications to MRI examination.
* No prior MRI, US or mammography within the 6 months prior to the study.

Exclusion Criteria:

* Had a screening contrast-enhanced breast MRI within the past 24 months or diagnostic contrast-enhanced MRI on any study breasts within the past 12 months;
* Had breast surgery and/or a core biopsy on the study breast(s) performed within the prior 6 months on the study
* Currently receiving chemotherapy \[with exception to participant with personal history of cancer, and on chemoprevention with Tamoxifen, Evista (Raloxifene), Arimidex (Anastrozole), Aromasin (Exemestane) or other aromatase inhibitor\];
* Participant with severely impaired renal function with estimated glomerular filtration rate (GFR) \< 30 mL/min/1.73m2 and/or on dialysis.
Comparative Effectiveness of Acupuncture and Nonsteroidal Anti-inflammatory Drugs for the Management of Aromatase Inhibitor Induced Arthralgia Among Breast Cancer Survivors

Hormone therapy is used to treat women with hormone receptor-positive breast cancer and aromatase inhibitor (AI) is administered after menopause. AI therapy has been proven to be effective in improving the disease-free survival rate, decreasing the recurrence rates and a lower incidence of contralateral breast cancer. However, arthralgia frequently reported as an important adverse event of AI therapy and sometimes resulted in noncompliance with AI therapy. The prevalence of AI induced arthralgia rates ranged from 20 to 74%. Inadequately managed AI induced arthralgia remains a major unmet need in oncology practice in breast cancer survivors.

The goal of this project is to conduct a crossover designed pragmatic clinical trial to evaluate the effectiveness of acupuncture versus NSAID (Diclofenac) for the management of aromatase inhibitor induced arthralgia.

The third group was set to use non-steroidal analgesics plus acupuncture to evaluate the effectiveness of joint pain.


Eligibility Criteria:
Inclusion Criteria:

* Women who were postmenopausal aged more than 20 years old.
* history of stage 0 to III hormone receptor-positive breast cancer, and currently taking a third-generation AI (anastrozole, letrozole, or exemestane) for at least 3 month.
* Those who reported pain and/or stiffness in one or more joints, which started or worsened after initiation of AI therapy had worst joint pain rated at least three or greater on a 0-10 numerical rating scale in the preceding week.

Exclusion Criteria:

* any prior acupuncture use for AI-induced joint symptoms or acupuncture within 1 months before entry
* inflammatory, metabolic, or neuropathic arthropathies
* bone fracture/surgery of an afflicted extremity during the preceding 6 months
* allergy to NSAID
* current use of narcotics
* bleeding or coagulation disorders
* localized skin infections
* needle phobia
* intra-articular corticosteroid within 4 weeks preceding the study
* any severe chronic or uncontrolled comorbid disease