cyrilzakka/clinical-trials huggingface dataset:
Repeated Low-Level Red-Light Therapy for Shortening Axial Length

The purpose of this clinical trial is to confirm the incidence and magnitude of axial length shortening after RLRL therapy in Chinese high myopia children and teenagers.

High myopia has become a major public concern globally, which is characterized by excessive axial elongation of the eyeball. Axial elongation is accompanied by mechanical stretching and thinning of the choroid and sclera, causing vision-threatening complications. RLRL therapy is an emerging effective and safe therapy for myopia control. Previous clinical trials in China have observed clinically significant axial shortening after RLRL treatment.

The purpose of this study is to confirm and identify possible mechanism for axial length (AL) shortening after 12-month RLRL therapy in Chinese highly myopic children and teenagers aged 6-16 years. In addition to single vision spectacles, subjects will receive RLRL treatment at home under supervision of the parents according to a standard protocol. Axial length, visual acuity, cycloplegic spherical equivalent refraction, intraocular pressure, slit lamp, optical coherence tomography, optical coherence tomography angiography and ultrawide-field optical coherence tomography will be measured at 1-, 3-, 6- and 12-month follow-up visits. This trial will be extended to 3 years and follow-up visits are scheduled at 18-, 24-, 30- and 36-month.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of consent.
2. Age: ≥ 6 and ≤ 16 years at enrolment.
3. High myopia: cycloplegic sphere ≤ -6.00 diopters (D) in both eyes.
4. Willing and able to participate in all required activities of the study.
5. The children currently on myopia control treatment can be recruited if myopia control treatments (including but not limited to atropine, orthokeratology, rigid gas-permeable lenses, defocus spectacles, etc.) are discontinued for at least 2 weeks.
6. Normal fundus, tessellated fundus or with peripapillary diffuse chorioretinal atrophy.

Exclusion Criteria:

1. Secondary myopia, such as a history of retinopathy of prematurity or neonatal problems, or syndromic myopia with a known genetic disease or connective tissue disorders, such as Stickler or Marfan syndrome.
2. Pathologic myopia with signs of macula-involving diffuse chorioretinal atrophy, patchy chorioretinal atrophy, macular atrophy, lacquer cracks, myopic choroidal neovascularization or Fuchs' spots.
3. Strabismus and binocular vision abnormalities in either eye.
4. Previous any intraocular surgery affecting refractive status.
5. Other reasons, including but not limited to ocular or other systemic abnormalities, that the physician may consider inappropriate for enrolment.
Enhancing Emergency Practitioner (EP)-Performed Alcohol Interventions in the Emergency Department (ED)

The purpose of this study is to evaluate the effectiveness of an enhanced emergency practitioner (EP) performed brief intervention (BI), namely, the Enhanced Brief Negotiation Interview (E-BNI). This includes a basic BNI performed in the ED with referral to a primary care provider, followed by a telephone booster intervention performed by trained nurses 1-month post ED visit. The E-BNI will be compared to the basic BNI (without booster), and standard care with assessments (SC-A) and without (SC-NA). In a randomized, controlled clinical trial 900 hazardous and harmful (HH) drinkers will be randomly assigned to one of the 4 conditions. We, the researchers at Yale University, will conduct cost benefit analysis of the interventions. Follow-up assessments, at 6 and 12-months, will be obtained via interactive voice response (IVR).

A critical need exists to refine and test brief interventions (BI) for Emergency Department (ED) populations with hazardous and harmful (HH) drinking that can be translated into real-world settings; and to enhance the effects of these BIs so they can be maintained over time. The ED is an ideal setting for BIs, as many ED patients who exceed low-risk recommendations do not have contact with either alcohol treatment specialists or visit primary care medical practitioners. This includes a large segment of young adults ages 18-30 whose only contact with the health care system is often an ED visit. The purpose of this study is to evaluate the effectiveness of an enhanced Emergency Practitioner (EP) performed BI, namely, the Enhanced Brief Negotiation Interview (E-BNI). This includes a basic BNI performed in the ED with referral to a primary care provider, followed by a telephone booster intervention performed by trained nurses 1-month post ED visit. The E-BNI will be compared to the basic BNI (without booster), and standard care with assessments (SC-A) and without (SC-NA). In a randomized, controlled clinical trial 900 HH drinkers will be randomly assigned to one of the 4 conditions. We will conduct cost benefit analysis of the interventions. Follow-up assessments, at 6 and 12-months, will be obtained via interactive voice response (IVR).

Eligibility Criteria:
Inclusion Criteria:

* Patients, 18 years or older, who present to the adult ED at Yale-New Haven Hospital will be screened for exceeding the NIAAA criteria for low-risk drinking
* Patients may be hazardous "at-risk" drinkers who screen over the limits, but do not currently exhibit medical, social or legal problems as a result of their drinking, or they may be harmful drinkers, presenting with an alcohol associated injury or illness.

Exclusion Criteria:

Patients will be excluded for the following reasons:

* Non-English speaking;
* Alcohol dependence;
* Current enrollment in a substance abuse treatment program;
* Current ED visit for acute psychiatric complaint;
* Condition that precludes interview i.e., life threatening injury/illness;
* In police custody; or
* Inability to provide two contact numbers for follow-up.
Phase 2a Placebo-Controlled Study of VTX3232 Alone or in Combination With Semaglutide in Obesity

This is a study to understand if taking VTX3232 alone or in combination with semaglutide is safe in participants diagnosed with Obesity. Approximately 160 patients will take VTX3232 Dose A, Placebo, VTX3232 Dose A in combination with semaglutide, or Placebo in combination with semaglutide.

This study consists of a 30-day Screening Period (to see if a participant qualifies for a study), a 12-week double-blind treatment period (a participant receives VTX3232 Dose A, Placebo, VTX3232 Dose A in combination with semaglutide, or Placebo in combination with semaglutide), and a 30-day Follow-Up Period. The maximum duration of treatment will be approximately 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Participants are male or female ≥ 18 years up to ≤ 80 years of age.
* Ability to comply with study requirements.
* BMI ≥ 30.0 to ≤ 42.0 kg/m2 at screening.
* Stable body weight (± 5%) for at least 3 months prior to screening.
* hs-CRP ≥ 2 mg/L at screening.
* Hypertension or hyperlipidemia which are known to be associated with increased risk of cardiovascular events, if present, must be controlled with stable dose/therapy.
* History of at least one self-reported unsuccessful dietary effort to lose body weight.

Exclusion Criteria:

* Obesity induced by endocrinologic disorders, or diagnosed genetic or syndromic forms of obesity
* Have any prior diagnosis of diabetes mellitus
* Current participation (or within the last 3 months) in an organized weight reduction program.
* History or presence of clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction) or chronically take drugs that directly affect GI motility, have undergone prior surgical treatment for obesity (e.g., gastric bypass \[bariatric\] surgery or restrictive bariatric surgery), or have an endoscopic and/or device-based therapy for obesity.
* Clinically relevant medical condition(s) that put the participant at risk or will make implementation of the protocol or interpretation of the study difficult.
* Use of any medication (e.g., GLP-1 agonists), nutritional supplement, or over the counter product for weight loss within the previous 6 months or during study participation, unless administered as a part of assigned study treatment in this study.
* Receipt of the following medications:

  1. Any immunosuppressive biologic or targeted therapy within 90 days prior to Day 1.
  2. Use of anti-inflammatory medications within 30 days prior to Day 1
  3. Colchicine within 30 days prior to Day 1.
  4. Glucose-lowering agent(s) administered for conditions other than diabetes within 90 days before screening.
Lidocaine as an Anesthetic Adjuvant in Liver and Gastric Laparoscopic Surgery

The aim is to analyze the effect of intravenous lidocaine administration on postoperative opioid use in patients undergoing upper abdominal cancer surgery. Specifically, those patients undergoing gastric cancer surgery and liver cancer surgery using a laparoscopic approach

In a recent Cochrane Library review, despite the apparent positive results reported by intravenous administration of lidocaine as a perioperative analgesic adjuvant, the quality of the evidence is low, since the studies carried out to date present small samples, great variability in the designs and different surgical techniques studied.

More studies will be needed to help improve the grade and quality of evidence in the management of acute postoperative pain and its role in opioid sparing, an especially beneficial effect in tumor pathology For this reason, the investigators have designed a randomized, double-blind, phase IV clinical trial with two treatment arms, parallel groups, in which 96 patients who underwent liver and gastric cancer surgery through laparoscopic approach participated.

This study will include 2 different population groups: patients undergoing liver cancer surgery and patients undergoing gastric cancer surgery

Eligibility Criteria:
Inclusion Criteria:

* Men and women over 18 years of age scheduled for gastric or liver cancer surgery through a laparoscopic approach at the University of Girona Dr Josep Trueta.
* Accept and sign the informed consent

Exclusion Criteria:

* decline participating in the study at any stage of its development.
* History of allergic or adverse reactions to Amide-type anesthetics.
* Pregnancy or lactation period
* Diagnosis of Child-Pugh stage B or C liver failure.
* Acute renal failure (GFR \<60 ml / min).
* Concomitant treatment with opioids for chronic pain.
* Any condition that, in the clinical judgment of the researchers, may interfere with the object of the research.
Study of Artelon FLEXBAND® for Patients Undergoing Soft Tissue Reconstruction of the Anterior Talofibular Ligament (ATFL) to Treat Lateral Ankle Instability

The goal of this clinical trial is to analzye return to pre-injury activity level on study participants with lateral ankle instability undergoing a modified Bröstrom reconstruction procedure for repair of the ATFL. Study participants undergoing ATFL reconstructive procedure using the ARTELON FLEXBAND System as an augmentation device will be compared to study participants undergoing a standard modified Bröstrom procedure alone. Clinician reported safety and functional outcomes measures will be collected at baseline; and at 2-, 6-, 12-, 18 and 26-weeks and 1- and 2-years post-surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects between and including the age of 18-75 at the time of surgery.
2. Subjects who were diagnosed with lateral ankle instability by physician clinical assessment.
3. Subjects who will undergo a modified Bröstrom procedure for an ATFL repair with or without FLEXBAND augmentation device (does not require an isolated repair).
4. Subjects that are able to understand, complete and sign the Consent Form.

Exclusion Criteria:

1. Significant secondary procedures done at the time of repair, including significant osteochondral lesions and/or significant microfracture of the talus or tibia that warrant modifying the typical lateral ligament repair post-op rehab protocol (minor microfractures and OCD lesions that do not warrant major bone debridement, synovectomies, and bone spur/osteophyte removals are allowed).
2. Any concomitant orthopedic procedure that will extend the post-op rehabilitation (e.g., casting/immobilization) beyond the routinely prescribed rehab protocol following an ATFL reconstructive procedure.
3. Subjects undergoing a Calcaneal osteotomy.
4. Subjects requiring major additional tendon surgery (i.e., peroneal tendon repair or tenodesis).
5. Neuropathy.
6. Subjects with diabetes, who, in the opinion of the investigator, are not sufficiently controlled.
7. BMI greater than 40 kg/m2.
8. Subjects with active Worker's Compensation Cases
9. Any subject with a history of infection of the ankle predating the ankle repair.
10. Subjects with a systemic ligament laxity disorder (i.e., Ehlers-Danlos Syndrome).
11. Any orthopedic issue outside of the ankle that the Investigator feels may impede functional endpoint outcome measures.
12. Subjects who have a medical history that would likely make the subject an unreliable research participant.
13. Subjects that are nursing or pregnant at the time of surgery.
14. Subjects with physician assessed untreated alcohol or substance abuse at the time of screening.
15. Subjects who are currently enrolled or participated in another investigational device, drug, or biological trial within 60 days of screening.
Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis

Primary objective:

- to evaluate the efficacy of Sarilumab in participants with Ankylosing Spondylitis (AS) using the assessment in AS working group criteria (ASAS) 20% response criteria (ASAS20)

Secondary objectives:

* to demonstrate that Sarilumab was effective on:

  * assessment of higher level of response \[ASAS 40% response criteria (ASAS40)\]
  * partial remission
  * disease activity
  * range of motion
  * Magnetic Resonance Imaging (MRI) of the spine
* to assess the safety and tolerability of Sarilumab in participants with AS as well as the pharmacokinetic profile of Sarilumab in participants with AS

The duration of participation in this study for each participant was approximately 22 weeks; including up to 4 weeks screening period, 12-weeks double-blind treatment period and 6-weeks safety follow-up period.

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of AS according to the New York modified criteria
* Participants must had an adequate trial of at least 2 different Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) taken for at least 2 weeks in each case and, on a stable dose for ≥2 weeks or be intolerant to NSAIDs
* Participants must had active AS for ≥3 months before screening and active disease must be present at screening and at baseline; Active AS being defined by:

  * Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of ≥4 (Numerical Rating Scale 0-10)
  * Total back pain score ≥4 (Numerical Rating Scale 0-10)

Participants treated with corticosteroid must be on a stable dose for ≥2 weeks prior to baseline

Participants treated with the Disease Modifying Anti-Rheumatic Drugs (DMARDs) hydroxychloroquine, sulfasalazine and methotrexate (MTX) must be on stable dose ≥12 weeks prior to baseline

Exclusion criteria:

* \<18 years old or ≥75 years old
* Complete fusion of the spine
* Past history of non response to any anti-Tumor Necrosis Factors (TNFs) treatment or non response to any other biological treatment for AS
* Any past or current treatment with anti-TNF's or any biological agent within 3 months prior to screening
* Treatment with DMARDs except for hydroxychloroquine, sulfasalazine and MTX
* MTX \>25 mg/week
* hydroxychloroquine \>400 mg/day
* Sulfasalazine \>3 g/day
* Treatment with oral prednisone or equivalent corticosteroids \>10 mg/day within 6 weeks prior to screening
* Use of intramuscular or intra-articular corticosteroids within the last 4 weeks before screening
* Previous treatment with cyclosporine, azathioprine

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Evaluation of the INDICAID™ COVID-19 Rapid Antigen Test

The INDICAID™ Rapid Antigen Test was used in real-world outbreak testing. The antigen test was used together with PCR testing. This study was designed to evaluate whether the addition of a rapid antigen test decreased time to results in a real-world setting.

Description of the INDICAID™ COVID-19 Rapid Antigen Test The INDICAID™ Rapid Test by PHASE Scientific is a LFA designed for the qualitative detection of SARS-CoV-2 nucleocapsid protein in nasal swab samples.

Sample collection and procedure To collect a sample, a nasal swab sample is collected by inserting the provided swab 1 inch into the nasal cavity. The swab is rubbed against the inside walls of both nostrils 5 times in a large circular path. The swab is then dipped into a buffer solution to elute the sample. Finally, three drops of the buffer solution-specimen mix are applied to the LFA test device. After 20 minutes, the user observes the test device for the presence or absence of a test line that indicates detection of the SARS-CoV-2 antigen. An Internal Quality Control line is included to indicate whether the test has been performed correctly.

COVID-19 outbreak screening with the LFA In this Dual-Track testing approach, the LFA is used to identify preliminary positives to trigger prioritization of sample processing for subsequent RT-PCR confirmatory testing.

In Approach A, a preliminary positive result from the LFA would expedite the corresponding patient VTM sample for laboratory-based RT-PCR. Expedited testing would obtain results. In Approach B, a preliminary positive result from the LFA result would trigger the testing of the corresponding patient VTM sample with an onsite rapid nucleic acid amplification test (cobas® SARS-CoV-2 \& Influenza A/B Nucleic acid test on the cobas® Liat system, Roche Molecular Diagnostics). In addition to the onsite rapid RT-PCR test, the corresponding patient VTM sample was also sent for expedited laboratory-based RT-PCR testing. All samples testing negative with the LFA were sent for RT-PCR testing.

Eligibility Criteria:
Inclusion Criteria:

* at least 5 years of age and report onset
* at least two of the following COVID-19 symptoms within 5 days or less: fever or chills, fatigue, sore throat, congestion or runny nose, cough, headache, diarrhea, shortness of breath or difficulty breathing, muscle or body aches, new loss of taste or smell, nausea, or vomiting.

Exclusion Criteria:

* That do not fit inclusion criteria or vulnerable populations
Nebulized Dexmedetomidine Versus Neostigmine/Atropine in Postdural Puncture Headache

In our study, we will compare a new route of nebulization for effectiveness between dexmedetomidine, neostigmine/atropine and saline placebo for females complained of postdural puncture headache (PDPH) after cesarean section.

A written informed consent will be taken from the patients. The study will involve female adults (age 18-40years) of American society of anesthesiologists (ASA) I-II who are listed for elective cesarean section under spinal anesthesia and suffer from postoperative postdural puncture headache (PDPH). Patients will be assigned randomly to three groups (30 subjects each) after PDPH diagnosis was established. First 90 patients developed PDPH will be assessed for study eligibility.

Group D (patients will receive ultrasonic nebulization of dexmedetomidine (1 mg/kg diluted in 4 mL saline) twice daily for three days. Group N (patients will receive nebulization of 20 µ/kg neostigmine and 10 µ/kg atropine mixed in 4 ml) twice daily for three days. Group S (patients will receive nebulization of saline placebo in 4 ml) twice daily for three days.

Eligibility Criteria:
Inclusion Criteria:

- Clinical diagnosis of postdural puncture headache (PDPH) after elective cesarean section under spinal anesthesia.

Exclusion Criteria:

* Hypersensitivity of dexmedetomidine, neostigmine or atropine
* Overactive thyroid gland
* Myasthenia gravis
* Closed angle glaucoma
* High blood pressure and coronary artery disease.
* withdrawal of consent
Evaluation of the LDL-C Lowering Effects of Ezetimibe Achieved in Co-administration Therapy With Statins in an Indonesian Population (Study P04276)(COMPLETED)

The purpose of this study is to evaluate the safety and tolerability of the low-density lipoprotein-cholesterol (LDL-C) lowering in an Indonesian population treated with ezetimibe co-administered with a statin in routine daily practice. In addition, the study will investigate whether and to what extent the target levels set by the participating doctors are achieved by the co-administration therapy.

Sampling method: invitation to the physician's patients.

Eligibility Criteria:
Inclusion Criteria:

* All subjects that were to receive ezetimibe 10 mg as prescribed in daily practice

Exclusion Criteria:

* N/A
Alcohol Consumption and Gallbladder Cancer

This case-control study matched by age and sex was performed to evaluate the region specific risk factors for gallbladder cancer in Jeju island, Korea.

In order to estimate region-specific risk factors for gallbladder cancer (GBC) in Jeju island, Korea the investigators performed a case-control study. Among 124 GBC patients and 7088 health controls, the investigators randomly selected 78 cases and 78 age-sex matched controls (1:1 matching) and compared their demographic features, combined diseases, and personal histories about known risk factors until now.

Eligibility Criteria:
Inclusion Criteria:

* Case group : newly diagnosed gallbladder cancer patients in Digestive Disease Center, Department of Internal Medicine in Cheju Halla General Hospitalduring 2008-2013
* Control group : 1:1 age-sex matched controls underwent health care screening program in Department of Health Promotion Center in Cheju Halla General Hospital for 2008-2012.

Exclusion Criteria:

* Case group Ambiguous diagnosis primary tumor involving common bile duct follow up loss without pathologic confirmation Incomplete clinical records Couldn't be assessed the results of operation or radiologic imaging.
* Control group Cases unavailable for gallbladder imaging (abdominal ultrasonography ,computed tomography, or magnetic resonance imaging) Cases underwent previous cholecystectomy before enrollment.