cyrilzakka/clinical-trials huggingface dataset:
Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia

Phase 3 study to evaluate the safety and effectiveness of LNZ101 for the treatment of Presbyopia.

Phase 3 study to evaluate the safety and effectiveness of LNZ101 compared with LNZ100 and Brimonidine for the treatment of Presbyopia.

Eligibility Criteria:
Inclusion Criteria:

1. Be able and willing to provide written informed consent and sign a Health Information Portability and Accountability Act (HIPAA) form prior to any study procedure being performed;
2. Be able and willing to follow all instructions and attend all study visits;
3. Be 45-75 years of age of either sex and any race or ethnicity at Visit 1;
4. Have +1.00 to -4.00 diopter (D) of sphere calculated in minus cylinder (so that spherical equivalent (SE) results in myopia no more severe than -4.00 D MRSE) in both eyes determined by manifest refraction documented at Visit 1;
5. Have ≤2.00 D of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at Visit 1;
6. Be presbyopic as determined at Visit 1

Exclusion Criteria:

Subjects must not:

1. Be a female of childbearing potential who is currently pregnant, nursing, or planning a pregnancy;
2. Have known contraindications or sensitivity to the use of any of the study medications or their components;
3. Have an active ocular infection at Visit 1 or at Visit 2 (bacterial, viral, or fungal), positive history of an ocular herpetic infection, preauricular lymphadenopathy, or ongoing, active ocular inflammation in either eye;
4. Have moderate or severe dry eye defined as total central corneal fluorescein staining in either eye at Visit 1;
5. Have clinically significant abnormal lens findings including early lens changes in either eye during dilated slit-lamp biomicroscopy and fundus exam documented within 3 months of Visit 1 or at Visit 1;
VAS-2 Vasectomy With the Vax-X

The purpose of this research study is to study an experimental vasectomy device called the Vas-X. This is an experimental study of this new approach to vasectomy.

The Vas-X works by stripping the lining of the vas deferens, the tube that sperm pass through during ejaculation. It is used in a way very similar to routine vasectomy, however, in a routine vasectomy, the vas is burned with an electrical device. With the Vas-X, there is no burning. The investigators are testing the Vas-X to determine whether it will offer a better way of performing a vasectomy.

The investigators will conduct this study at the University of Washington Medical Center, Seattle.

Eligibility Criteria:
Inclusion Criteria:

* healthy male with normal physical findings
* normal testicular volume (15-30mL)
* detectable sperm in ejaculates

Exclusion Criteria:

* Men with past history of

  * hypertension
  * significant cardiovascular
  * thromboembolic disorders
  * renal (including undiagnosed urinary tract bleeding)
  * hepatic, prostatic and testicular disease
  * prior vasectomy or scrotal surgery
  * infertility
* Men with a past history of drug abuse will also be excluded.
The Severity of Periodontitis at the Buccal and Palatal Site

To record and compare the periodontal conditions of buccal and palatal sites in patients


Eligibility Criteria:
Inclusion Criteria:

* patients with diagnosed periodontitis

Exclusion Criteria:

* compromised systematic health (uncontrolled hypertension, diabetes, impaired bone metabolism condition, etc.), uncontrolled periodontal disease, smoking \> 20 cigarettes/day or recent chemotherapy/radiotherapy in the oral and maxillofacial regions
Evaluation of Saccharomyces Boulardii Combined With Standard Quadruple Therapy for Eradication of Helicobacter Pylori

The eradication rate of standard quadruple therapy has become less successful due to low compliance and high resistance to the antibiotics. Therefore, it is necessary to develop new treatment strategies that increase the eradication rate and reduce adverse effects. The aims of this prospective study is to investigate the efficacy of Saccharomyces Boulardii sachets for eradication of Hp, compared with standard quadruple therap.

In China, the first-line therapy to treat Helicobacter pylori (Hp) consists of a bismuth-based proton pump inhibitor (PPI) and two antibiotics for 14 days. But, eradication has become less successful due to low compliance and high resistance to the antibiotics. Therefore, it is necessary to develop new treatment strategies that increase the eradication rate and reduce adverse effects. Several studies previously suggested that probiotics could be effective for improving Hp eradication rate or reducing adverse events with PPI-based triple therapy. But, their effect for eradication of Hp is not yet conclusive. And the experiments now available about efficacy of Saccharomyces Boulardii were mainly combined with triple therapy. The aims of this prospective study is to investigate the efficacy of Saccharomyces Boulardii sachets for eradication of Hp, compared with standard quadruple therapy.

Eligibility Criteria:
Inclusion Criteria:

* Helicobacter pylori infected patients
* 13C DOB\>8
* age 22\~65

Exclusion Criteria:

* prior Hp eradication therapy including amoxicillin and clarithromycin
* previous gastric resection
* allergic to the drugs used in this study
* previous use of proton pump inhibitors, bismuth, H2 receptor antagonist or antibiotics, probiotics within 4 weeks of the study
* Patients who were pregnant or lactating
* Patients taking NSAIDs, alcoholic or with other serious disease (e.g. hepatopathy, heart disease, nephropathy，diabete mellitus, hypertension...) effect the evaluation of this study
* Can't express the complaint correctly
Extension Study to Evaluate the Long-term Outcomes of Subjects in the CLS-AX CLS1002-101 Study

This is an open-label, non-interventional extension study of up to 12 weeks in duration in subjects completing Cohorts 2, 3, and 4 of the Parent study, CLS1002-101.

This is an open-label, non-interventional extension study of up to 12 weeks in duration in subjects completing Cohorts 2. 3 and 4 of the Parent study, CLS1002-101. The Parent study is a 12-week, Phase 1/2a, multicenter study designed to assess the safety and tolerability of a single dose of CLS-AX administered suprachoroidally in subjects with neovascular age-related macular degeneration (nAMD) who show stable visual acuity following 3 or more injections with an intravitreal (IVT) anti-VEGF therapy in the preceding 5 months.

Summary analyses will include 12-weeks data from the Parent study, CLS1002-101, and 12-weeks data from this extension study, CLS1002-102, for a total of 24 weeks follow-up, for all participants enrolled into the extension study.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in and completed the Parent study, CLS1002-101, as part of Cohort 2 or Cohort 3 or Cohort 4.

Exclusion Criteria:

* Received prohibited medication in the Parent study, CLS1002-101.
* Enrolled in the Parent study CLS1002-101 as part of Cohort 1.
* Females of childbearing potential who are pregnant and or lactating.
Short and Long-term Effects of Adding Oral L-arginine to Standard Therapy in Patients With COVID-19 (SARS-CoV-2)

Single-center study with a parallel group scheme, double-blind, randomized, placebo-controlled, to evaluate whether the addition to the investigator's hospital standard therapy of two vials of Bioarginina® per day in subjects with SARS-CoV-2 is useful for treatment of this pathology.

Preliminary experiences conducted in patients affected by SARS-CoV-2 infection by adding the daily oral administration of two vials of Bioarginina® to the standard therapy have shown favorable effects on discharge times, on the recovery of the number of lymphocytes and on the P \\ F ratio between arterial pO2 and FiO2 breathed. In particular, for the latter parameter there is almost a doubling of the recovery speed.

The investigators therefore, decided to undertake the present spontaneous, single-center study with a parallel group scheme, double-blind randomized, placebo-controlled to evaluate whether the addition to the standard therapy of two vials per day of Bioarginina® in subjects of our hospital suffering from SARS-CoV-2 is useful for the treatment of this pathology.

Eligibility Criteria:
Inclusion Criteria:

* age\> 18 years
* Diagnosis of COVID 19, confirmed by RT-PCR on a nasopharyngeal swab
* COVID 19 pneumonia with the following clinical characteristics: SpO2 in ambient air \<93% and Alveolar pressure of oxygen / inspiratory fraction of oxygen (PaO2 / FiO2 - P / F \<300 mmHg.
* Lymphocytopenia defined as lymphocytes \<1500 / mcL or \<20% of white blood cells

Exclusion Criteria:

* History of intolerance to L-arginine
* Severe chronic pulmonary disease
* Pregnancy or breastfeeding
* Neutropenia due to neoplasms of the haematopoietic system or other organs with invasion of the bone marrow
* Use of immunosuppressive drugs or cytotoxic chemotherapies within the previous three weeks
* Refusal to give consent to participate in the study
Study of Immune Responses After Vaccination Against Seasonal Influenza Virus and Against Influenza H1N1-v Pandemic Virus in a Medical Staff.

This project may help to answer several fundamental questions related to public health regarding vaccination against influenza viruses and regarding the influenza A(H1N1)v pandemy:

What is the immunologic efficacy in terms of antibodies response of the vaccination against the seasonal (2009-2010) influenza virus and against the A(H1N1)v virus in the clinical staff?

Moreover, it may help to answer questions related to the use of a vaccine against influenza virus variants emerging in the French population:

1. Before the vaccination:

   * What is the status of the residual anti-H1N1 seasonal viruses immunity and of the anti-A(H1N1)v immunity in the population stratified by age and taking into account the multiplicity of the prior seasonal vaccinations?
   * What is the level of the cellular and humoral cross-reactivity between the different H1N1 strains?
2. After the vaccination:

   * What is the intensity of the anti-vaccine immune response as a function of the age of the population ad of the prior seasonal vaccinations?
   * What is the level of the cellular and humoral cross-reactivity after vaccination as a function of the age of the population and of the multiplicity of the prior seasonal vaccinations?


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Age superior or equal to 20 years
* Women with childbearing potential using contraception

Exclusion Criteria:

* Documented immune depression
* Current immunosuppressive therapy
* Pregnancy (documented by a positive pregnancy test)
* Breast feeding women
* Documented allergy or hypersensitivity to vaccines
* Documented acute or chronic inflammatory disease
* Concomitant participation to another clinical trial
Effect of Blood Flow Restriction Technique on Delayed Onset Muscle Soreness

The aim of our study is to determine and evaluate the effects of blood flow restriction technique on pain, biomechanical properties and strength of the muscle in delayed onset muscle pain in healthy individuals. A Double Blind, Randomized Controlled, prospective study was planned.

All participants will be taken into the DOMS creation protocol. Participants will then be divided into 80% intensity BFR and 20% intensity Blood Flow Restriction technique (BFR) groups and will be included in an exercise protocol accompanied by BFR application.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals between the ages of 18-35 (who have not participated in any resistance training program for at least 6 months)

Exclusion Criteria:

* Having a previous musculoskeletal system injury
* Having a condition that prevents resistance exercise
* Having cardiovascular disease
* Using medication for blood pressure control
Distance for Interscalene Block

Patients experience significant postoperative pain following shoulder surgery, Single shot interscalene block is used in ambulatory shoulder surgery for its advantages that include significant reduction in acute pain and analgesic requirements, prolonged time to first analgesic request, decreased incidence of nausea, as well as earlier hospital discharge.The process of nerve block requires several needle passes, with each of them being at risk of causing nerve injury either by direct trauma or intraneural injection even with the use of the ultrasound. These facts raised concerns and several authors stated that maybe the anesthesiologists should be more careful, keep a safe distance from the nerve, and inject the local anesthetics into fascial planes containing the nerve and not attempt to place the needle in close proximity to the nerve. This study is designed to determine the maximal effective distance away from the nerve for the injection to be effective.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-III
* 18-85 years of age, inclusive
* surgery less than 3 hours

Exclusion Criteria:

* contraindications to brachial plexus block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area)
* existing neurological deficit in the area to be blocked
* pregnancy
* history of neck surgery or radiotherapy
* severe respiratory disease
* inability to understand the informed consent and demands of the study
Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus

Study D5553C00002 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 3 study to compare the safety and efficacy of exenatide once weekly (EQW) added to titrated basal insulin glargine with or without metformin to placebo added to titrated basal insulin glargine with or without metformin in patients with type 2 diabetes mellitus (T2DM). Eligible patients will be randomized at Visit 5 (Day 1) to receive either EQW added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, or placebo added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, during the 28-week treatment period.


Eligibility Criteria:
Inclusion criteria:

* Has a diagnosis of Type 2 Diabetes Mellitus (T2DM)
* Has HbA1c of 7.5% to 12.0%, inclusive, at Visit 1 (Screening).
* Has fasting plasma glucose (FPG) concentration \<280 mg/dL (15.6 mmol/L) at Visit 1 (Screening)
* Treated with basal insulin glargine at a dose of ≥20 units/day once daily for at least 6 weeks prior to Screening, in combination with diet and exercise alone or in combination with:

  1. a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to Visit 1
  2. a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to Visit 1 (Screening) and a stable dose of sulfonylurea for at least 8 weeks prior to the Screening visit

Exclusion criteria:

* Serum calcitonin concentration ≥40 pg/mL (≥40 ng/L) at Visit 1 (Screening)
* History of, or currently have, acute or chronic pancreatitis, or have triglyceride concentrations ≥500 mg/dL (≥5.65 mmol/L) at Visit 1
* Positive serological test for hepatitis B or hepatitis C
Jawline Improvement Using Patient-specific Angle Implants With Virtual Planning in Orthognathic Surgery

Background: Jawline improvement is nowadays a strong patients' demand. Among patients undergoing orthognathic surgery, it remains sometimes a challenge to manage angle definition due to the classic mandibular osteotomy trait which mostly allows sagittal mandibular movements but can't modify the ramus height. A few types of osteotomies can be used to improve jawline's shape while correcting malocclusion, but they remain technically difficult and often imply the necessity for bone grafting and/or the use of a specific saw and screwdriver. The advent of computer-assisted surgical planning and computer-aided design/ computer-aided manufacturing (CAD-CAM) techniques for patient-specific implant (PSI) fabrication has enabled new methods for managing the jawline in orthognathic surgery. The aim of this study was to assess jawline improvement with patient-specific angle implants in patients undergoing orthognathic surgery with standard osteotomies.Methods: A virtual simulation of a Le Fort I osteotomy (if needed), a sagittal split ramus osteotomy with patient-specific titanium angle implants, and a genioplasty (if needed) was conducted on a preoperative three-dimensional (3D) model of each patient's skull using ProPlan CMF software (Materialise, Leuven, Belgium). Computer-assisted osteotomy saw-and-drill guides and patient-specific implants (PSIs, titanium plates and angle implants) were produced and used during the surgery. The investigators chose to focus on jawline improvement by comparing the preoperative and the post-operative 3D-photographs using the VECTRA H2 3D imagine system (Canfield Scientific, \*\*).


Eligibility Criteria:
* Inclusion Criteria: patients undergoing orthognathic surgery and jawline correction with patient-specific angle implants at Head and Neck Institute, Nice, France
* Exclusion Criteria: None
Internet-Based Cognitive-Behavioral Therapy for Insomnia

The aim of this study is to develop an Internet-based self-help therapy program for insomnia in Chinese language, and to conduct a randomized waiting-list controlled trial on the efficacy of Internet-based self-help therapy for insomnia.

This study is a randomized controlled trial in patients with insomnia. Eligible subjects will be randomly assigned to self-help treatment with telephone consultation (SHTC), self-help treatment without telephone consultation (SH), or waiting-list control. The subjects will receive self-help treatment once per week for 6 consecutive weeks. In addition to self-help treatment, the subjects in SHTC group will receive telephone consultation once per week for 6 consecutive weeks.

Eligibility Criteria:
Inclusion Criteria:

* Hong Kong residents aged ≥18 years
* Predominant complaint of difficulty initiating or maintaining sleep or early morning awakening or nonrestorative sleep with associated distress or impairment in social, occupational and other important areas of functioning for at least 3 nights per week for at least 3 months based on self- administered questionnaire
* Able to read Chinese and type Chinese or English
* Have Internet access (PC/ mobile phone), and with an email address
* Willing to give informed consent and comply with the trial protocol

Exclusion Criteria:

* Have suicidal ideas based on self-report
Hati Salama (Secure Voucher)

The use of long-lasting insecticide treated nets (LLINs) is shown to reduce malaria prevalence. The Tanzania Net Voucher Scheme has been an active component of bed net distribution to pregnant women in Tanzania since 2004. The transition from paper vouchers to electronic vouchers in this program has increased efficiency and the ability to track and distribute nets since 2007. Although the program has been successful, to date, electronic voucher redemption varies widely across the country and it has not been clearly established as to what barriers exist for women who receive electronic vouchers in the program. This cluster-randomized trial was designed to examine perceived barriers to electronic voucher redemption among pregnant women and to evaluate if educational and personalized text messages around electronic voucher redemption and bed net usage will increase electronic voucher redemption when directed at pregnant women who receive electronic vouchers in the currently existing program.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women capable of providing informed consent
Platelet Rich Plasma (PRP) One-Shot Injection For Supraspinatus Tendinosis

It was conducted a prospective study with a series of 50 patients treated with PRP one-shot injection in patient affected by Supraspinatus Tendinosis. One independent observer performed clinical and functional evaluations at T0 (recruitment), T1 (one month after the injection), T2 (three months after the last injection) and T3 (six months after the last injection).

Constant Score, The Disabilites of the Arm,Shoulder and Hand Score (DASH) And Visual Analogue Scale (VAS) were administered at each evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old;
* Supraspinatus tendinosis detected by MRI.

Exclusion Criteria:

* Supraspinatus rupture;
* Previous shoulder surgery;
* Rotator cuff tears secondary to fracture;
* Hemoglobin \<7 g/dL or Platelets \< 30,000 microL;
* Active infection;
* Pregnant patients;
* Patients with hematologic and oncologic diseases.
Application of Artificial Intelligence Deep Learning Technology in Magnetic Resonance Lumbar Imaging

To study the comparative analysis of artificial intelligence deep learning technology in the image quality of under-artificial intelligence (AI) reconstruction images and the original acquisition images of magnetic resonance lumbar spine


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes, aged ≥18 years, with no history of lumbar surgery, underwent lumbar magnetic resonance imaging examination.

Exclusion Criteria:

* With metal implants in the body, claustrophobic, unable to lie flat for 15 minutes, with a history of lumbar surgery.
ARIA (Atacand Renoprotection In NephropAthy Pt.)

To determine the effective dose of candesartan cilexetil for reduction of urinary protein excretion in hypertensive patients with non-diabetic chronic kidney disease with baseline urinary protein/creatinine ratio between 500mg/g and 5000mg/g, by assessing the change in urinary protein/creatinine ratio from baseline to the end of 28-week treatment


Eligibility Criteria:
Inclusion Criteria:

* hypertension; a)135mmHg \< Systolic Blood Pressure \<180mmHg and/or 85 mmHg \< Diastolic Blood Pressure \<100 mmHg. or b) The subject has been treated with antihypertensive medication
* proteinuria (urinary protein/creatinine ratio between 500 mg/g and 5000 mg/g)

Exclusion Criteria:

* Current serum-creatinine \> 265 mmol/L (\>3 mg/dL).
* Current serum-potassium \> 5.5 mmol/L
* Known hypersensitivity to angiotensin (AT)1-receptor blocker
Pharmacokinetic/Pharmacodynamic Characteristics and Safety/Tolerability of MT921 in Healthy Subjects

To determine the pharmacokinetic/pharmacodynamic characteristics and safety/tolerability of MT921 in Healthy Subjects


Eligibility Criteria:
Inclusion Criteria:

* Adults aged between 20 and 65 years

Exclusion Criteria:

* Subject not appropriate for participating in this study according to the investigator's opinion