cyrilzakka/clinical-trials huggingface dataset:
A Phase 2 Study of OPC-262 in Patients With Type 2 Diabetes

A multicenter, randomized, double-blind, placebo-controlled, group-comparison study to investigate the safety and efficacy of OPC-262 in patients with type 2 diabetes


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes patients with HbA1c above 7.0% and below 10%
* Patients who are capable of giving informed consent
* Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner

Exclusion Criteria:

* Patients with type1 diabetes mellitus, patients with diabetes mellitus or impaired glucose tolerance (IGT) due to other specified mechanism or diseases, and patients with gestational diabetes mellitus
* Patients with a medical history of diabetes coma
* Patients with poorly-controlled hypertension
* Patients with heart failure
* Patients with a complication of active hepatitis or hepatic cirrhosis
* Patients undergoing treatment of glomeruler diseases other than diabetic nephropathy
* Patients with a history or complication of malignant tumor
Fatigue, Psychological Comorbidity and Quality of Life Among Patients With Chronic Pancreatitis in China.

This study will investigate the status of fatigue, psychological comorbidity and quality of life among patients with chronic pancreatitis in China and analyze their influencing factors.

Chronic pancreatitis (CP) is an inflammatory disease characterized by pancreatic fibrosis. Available studies suggested that the incidence of CP in China was about 13.5 per 100,000 people. Patients with CP often have symptoms of pancreatic endocrine and exocrine insufficiency such as elevated blood sugar, weight loss, muscle loss, combined with complications such as pancreatic duct stones, pancreatic duct stenosis, pancreatic pseudocysts, and have a higher risk of pancreatic cancer, which seriously affects the quality of life of patients.

Psychological comorbidities represented by anxiety and depression were thought to be widespread in CP patients, with available epidemiological studies indicating that the prevalence of anxiety and depression in CP patients in the United States was 36.8% and 46.8%, respectively. In addition, fatigue, as a subjective perception of decreased ability to perform physical and/or intellectual tasks, has also been founded among CP patients.

However, to date, there is a lack of epidemiological studies on fatigue, anxiety, depression and quality of life in Chinese patients with CP. This study will investigate the epidemiological status of fatigue, anxiety, depression, and quality of life in Chinese patients with CP and analyze the factors influencing them.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of chronic pancreatitis

Exclusion Criteria:

* Illiterate
* Having communication difficulties
* Unable to complete the questionnaires
* Having a history of psychiatric disorders
* Recent history of psychotropic and sedative drug use
* Pregnancy
* Rejected participants
Study of Impact of Art Therapy Sessions Given to Family Caregivers of Children With Type 1 Diabetes

Diagnostic of diabetes in childhood brought modification of family way of life, particularly in child and caregivers lifes.

The education patient programs are in France centered on curative competencies of care.

It is possible that art-therapy improve psycho-social competencies The aim of the study is to evaluate art-therapy sessions on quality of life of caregivers


Eligibility Criteria:
Inclusion Criteria:

* one of the family caregivers of child with diabetes enrolled in patient education programs of 3 hospitals (Hospital of Poitiers, Hospital of Niort and Hospital of La Rochelle)
* who accept the study
* ≥ 18 years
* free, with protection of vulnerable adult
* caregivers of child with who have insurance
* with free, enlightened, signed consent

Exclusion Criteria:

* other research participation
* \< 18 years
* host family
* with protection of vulnerable adult
* caregivers of child with who have not insurance
Multi-Drug Resistant Bacteria Carriage After Travel

During one month, from 1st to 30th November 2016, all patients admitted in one of the medical Dpt of our Hospital (Internal Medicine Dpt, Endocrinology, ICU) will be screened for multi-drug resistant bacteria carriage (after written consent). They will answer to a questionnaire about previous travel in a foreign country during the previous year, hospitalization or not during this travel.

During one month, from 1st to 30th November 2016, all patients admitted in one of the medical Dpt of our Hospital (Internal Medicine Dpt, Endocrinology, ICU) will be screened for multi-drug resistant bacteria carriage (after written consent), regardless a travel in a foreign country during the past year, or not. They will answer to a questionnaire about previous travel in a foreign country during the previous year, hospitalization or not during this travel. The aim of the study will be to compare the rate of carriage of multi-drug resistant bacteria among previous travelers, or not.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted in one of the medical Dpt of our Hospital who have travelled in a foreign country during the previous year

Exclusion Criteria:

* patients who were unable to give written consent
Perioperative Outcomes of Common Methods of Minimally Invasive Contained Tissue Extraction

The goal of this study is to compare common methods of tissue extraction at the time of minimally invasive surgery.

The goal of this study is to compare common methods of tissue extraction at the time of minimally invasive surgery, including vaginal extraction and mini-laparotomy; both performed within a containment system. The primary aim is to assess return to normal daily activities after each of the surgical techniques. Return to daily activities will be recorded on a post-operative patient activity diary recording the following tasks: a) work (if applicable), b) domestic tasks, c) driving a vehicle (if applicable) and d) physical exercise (if applicable). Additional information regarding post-operative pain (measured on a Likert scale), potential complications of each technique, such as tearing of the bag or leakage, and peri- and post-operative outcomes will be collected. In order to aid in detection of leakage, blue dye (either indigo carmine or methylene blue) will be added to the containment bag prior to morcellation.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or greater
* eligible to undergo laparoscopic Hysterectomy, as determined clinically by the operating surgeon

Exclusion Criteria:

* suspected malignancy
* medical illness precluding laparoscopy
* inability to give informed consent
* allergy to indigo carmine or methylene blue dye
Video-visit Behavior Therapy for Anxiety and Depression in Youth

This project focuses on adapting and pilot testing an efficacious brief behavioral therapy (STEP-UP) for youths with anxiety or depression to be delivered as a telehealth intervention by clinic staff in low-resource community health centers (CHCs).


Eligibility Criteria:
Inclusion Criteria:

* Youth is a patient at a participating community health center (CHC) site
* Youth is clinically referred by a provider and / or has anxiety and / or depression as a diagnosis or target problem in their medical record
* Youth is in the physical and legal custody of the caretaker and is not currently involved in the foster care system
* Youth is able and willing to conduct study assessments and intervention sessions in English
* Primary caretaker is able and willing to conduct study assessments and intervention sessions in English or in Spanish
* Youth is functioning at or above the academic level of a typical 8-year-old child (i.e., placed in at least the second-grade level school across all subjects in a general education classroom)
* Primary caretaker agrees that focusing on anxiety and / or depression would be a useful primary target for treatment
* Youth has clinically significant symptoms of anxiety and / or depression by youth or caretaker report

Exclusion Criteria:

* Youth is receiving an alternate intervention for anxiety or depression
* Youth or parent reports that the youth is experiencing active suicidal ideation with plan or intent (i.e., within last three months) and / or has made a suicide attempt within the last six months
* Youth or parent reports that the youth is currently engaging in non-suicidal self-injury (i.e., within last three months)
* Youth or parent reports that the youth has experienced recent physical or sexual abuse (i.e., within last three months).
Split-face Tolerability Comparison Between MetroGel® 1% vs Finacea® 15% in Subjects With Healthy Skin

The purpose of this study is to compare the tolerability of MetroGel® 1% to Finacea® 15% in subjects with healthy skin applied according to product labeling for three weeks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female adults (ages 18 years or older)
* Subjects with healthy skin as determined by the clinical grader

Exclusion Criteria:

* Subjects with a degree of skin pigmentation that interferes with the reading of skin reactions
* Subjects with known allergy to one of the components of the study drugs (refer to the package inserts for MetroGel® 1% and Finacea® Gel 15%)
* Subjects who have participated in another investigational drug or device research study within 30 days of enrollment
* Subjects with a washout period for topical treatment on the treated area less than 1 week for corticosteroids and/or 4 weeks for retinoids
* Subjects with a washout period for systemic treatment less than 1 week for medications that may increase photosensitivity and/or 4 weeks for corticosteroids and/or 6 months for retinoids
* Subjects with current sunburn, eczema, atopic dermatitis, perioral dermatitis, rosacea, or other topical conditions on the area to be treated
* Subjects who foresee unprotected and intense UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.)
Methotrexate - Inadequate Response Device Sub-Study

The purpose of this study is to determine the safety and acceptability of a device used in place of traditional syringes for abatacept self-injection.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, ages ≥ 18
* Participants who are considered methotrexate inadequate responders (MTX-IR)
* 10 or more swollen joints (66 joint count) and 12 or more tender joints (68 joint count)
* Participants were to have been enrolled in the main MTX-IR study and been treated with open label abatacept for at least 3 months in the long term period

Exclusion Criteria:

* Participants who failed one or multiple anti-tumor necrosis factor (TNF) therapies
* Participants who meet diagnostic criteria for any other rheumatic disease (e.g., lupus erythematosus)
* Participants with active vasculitis of a major organ system (except for subcutaneous rheumatoid nodules)
* Participants with severe chronic or recurrent bacterial infections
* Participants who have received treatment with rituximab
Analysis of I-Trace High Order Aberrations Induced by Wavefront Optimized Ablation Profiles

This work aims at the analysis of ocular aberrations induced by wave front optimized ablation profiles WFO using I-Trace aberrometer (Ray -Tracing)

The iTrace (Tracey Technologies, Houston, Tx) is uniquely designed to combine Placido corneal topography with a ray tracing aberrometer to measure quality of vision in a patient. This work aims at the analysis of ocular aberrations induced by wave front optimized ablation profiles WFO using I-Trace aberrometer (Ray -Tracing)

Eligibility Criteria:
Inclusion Criteria:

1. Myopia up to -8.0 D and astigmatism up to -2.0D.
2. Cases above 18 years of age with a stable refraction for at least one year.

Exclusion Criteria:

1. Keratoconus.
2. Patients with collagen diseases.
3. Previous LASIK or any other refractive surgery.
4. Severe dry eye syndrome.
A Study to Determine the Optimal Dose of Tildrakizumab (SCH 900222/MK-3222) for the Treatment of Moderate-to-severe Chronic Plaque Psoriasis (P05495) (MK-3222-003)

This is a response-driven study of tildrakuzumab for the treatment of moderate to severe chronic plaque psoriasis. The primary study hypothesis is that one or more doses of tildrakizumab will be superior to placebo for the treatment of psoriasis.

Each participant will be enrolled in the trial for approximately 72-76 weeks. Each participant will receive assigned treatment at Weeks 0 and 4 in Part I. At Week 16, the dosage of treatment the patient is assigned to may be adjusted based on the Psoriasis Area and Severity Index (PASI) 75 response (responder vs non-responder). Participants will receive study medication once every 12 weeks during Part 2 (Weeks 16 to 52); no participants will receive placebo in Part 2. Part 3 is an observational period and each subject will continue to be monitored on a monthly basis through Week 72. Subjects will not receive any study medication during Part 3.

Eligibility Criteria:
Inclusion Criteria:

* Adult participants (≥18 years of age) with a diagnosis of moderate-to-severe chronic plaque psoriasis (defined by ≥10% body surface area \[BSA\] involvement, "moderate" or greater score on the Physician's Global Assessment \[PGA\] scale, and PASI score ≥12 at Baseline)
* Participants must have a diagnosis of predominantly plaque psoriasis for ≥6 months (as determined by interview and confirmation of diagnosis through physical examination by investigator) and be considered candidates for phototherapy or systemic therapy. Participants with psoriatic arthritis may be included in the study

Exclusion Criteria:

* Nonplaque forms of psoriasis specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis
* Participants who will require oral or injectable corticosteroids during the trial
* Presence of any infection requiring treatment with systemic antibiotics within 2 weeks prior to Screening, or serious infection (eg, pneumonia, cellulitis, bone or joint infections) requiring hospitalization or treatment with intravenous antibiotics within 8 weeks prior to Screening
* Participants with evidence of active or untreated latent tuberculosis (TB) according to Screening criteria specified in the protocol. (Prophylactic treatment for latent TB as per local guidelines must be initiated at least 4 weeks prior to treatment with study medication)
* Previous exposure to any agents targeting interleukin-12 (IL-12) and/or Interleukin-23 (IL-23)
* Participants with prior exposure to two or more tumor necrosis factor (TNF) antagonists with discontinuation due to lack of efficacy.
Efficacy of Electrical Dry Needling in Pain, Sensitivity, Functionality and Quality of Life of Patients With Chronic Non-specific Low Back Pain

The main objective of this study is to determine the efficacy of electrical dry needling versus ischemic compression, analytical stretching and postural habits educational dossier in active myofascial trigger points in patients with chronic non-specific low back pain.

A double-blind clinical trial will be developed in a sample of 80 subjects with chronic low back pain. Patients in the experimental group will receive electrical dry needling at the active myofascial trigger points (PGM) of the quadratus lumbar, multifidus, and iliocostal muscles (following the PGM maps described by Travell and Simons). The technique will be performed using needle electrodes, the generated current will be produced by a TENS device with a frequency of 2 Hz and a pulse width of 250 μs, during 30 min of application. The therapeutic intervention will be 1 weekly session for a total of 6 weeks.

The control group will perform an ischemic compression technique in active PGM with a time between 20 seconds and 1 minute until pain inhibition is achieved, and finally, analytical stretching will be carried out on the quadratus lumbar, multifidus and iliocostal muscles. The treatment will consist of 1 weekly session for 6 weeks, in addition they will be provided with a training dossier on postural education in their activities of daily life.

A baseline assessment of the primary and secondary outcome measures will be carried out before randomization of the participants to the different groups, an immediate post-treatment assessment (1 day after the last intervention) and an assessment two month after the end of the intervention ( short-term follow-up).

The objectives of this study are to compare the repercussions of dry electropuncture versus ischemic compression in active PGM plus stretching in terms of pain, functionality, mobility of the spine, and quality of life in patients with non-specific chronic low back pain; and analyze the impact on active myofascial trigger points in terms of pressure tolerance threshold.

Eligibility Criteria:
Inclusion Criteria:

* Low back pain ≥ 3 months.
* Age between 30 and 67 years old.
* Not being receiving physical therapy.

Exclusion Criteria:

* Presence of lumbar stenosis.
* Diagnosis of spondylolisthesis.
* Diagnosis of fibromyalgia.
* Treatment with corticosteroids or oral medication in recent weeks.
* History of spine surgery.
* Contraindication of analgesic electrical therapy.
* Have previously received a treatment of electrical analgesia or exercise.
* Central or peripheral nervous system disease.
the Effect of Three Different Analgesic Techniques on the Incidence of Postoperative Nausea and Vomiting

Postoperative nausea and vomiting (PONV) is a distressing adverse effect that may result in postoperative complications including bleeding, wound dehiscence, aspiration pneumonitis, as well as fluid and electrolyte imbalances Incidence of PONV after general anesthesia is about 30% in all post-surgical patients but up to 80% in high-risk patients despite advances in anesthetics and anesthesia techniques

Postoperative nausea and vomiting (PONV) is a distressing adverse effect that may result in postoperative complications including bleeding, wound dehiscence, aspiration pneumonitis, as well as fluid and electrolyte imbalances.

The incidence of PONV after general anesthesia is about 30% in all post-surgical patients but up to 80% in high-risk patients despite advances in anesthetics and anesthesia techniques.

Despite new antiemetic drugs the overall incidences remain high especially in subjects with increased patient-related risk-factors such as in female gender, non-smoking status, a history of motion sickness or previous PONV, inhalational anesthetics, certain types of surgery, and opioid use. Scleral buckling (SB) which is still thought to be the most efficacious and cost-effective primary procedure for the treatment of uncomplicated retinal detachment is often associated with postoperative pain as well as nausea and vomiting. Preoperative injections of local anesthetics via retrobulbar, peribulbar, or subtenon routes in patients undergoing vitreoretinal surgery under general anesthesia (GA) have been reported to reduce postoperative pain, nausea, and vomiting.

Topical lidocaine drops have also has been used intraoperatively to decrease the incidence and severity of the OCR and to prevent pain and PONV after strabismus surgery and vitrectomy without scleral buckling .

The current study was designed to compare the effect of three different analgesic techniques ; IV analgesia , peribulbar block and topical xylocaine jel on the incidence of ponv after scleral buckling under general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* males or females
* aged between 18-80 years
* ASA physical status Ι\&II -indicated for repair of retinal detachment with scleral buckling. -

Exclusion Criteria:

* Patients with cardiac, liver and/or kidney diseases
* coagulation defects or receiving anticoagulants
* hypersensitivity to the used drugs
* history of motion sickness or PONV
* diabetes mellitus
* gastrointestinal disease
* smokers
* menstruating ladies
* ASA status more than II
Local Anaesthetic Infusion For Laparoscopic Hysterectomy

More hysterectomies are performed laparoscopically either as a total laparoscopic hysterectomy or as a laparoscopically assisted vaginal hysterectomy. The advantages of laparoscopic surgery include quicker hospital discharge, a shorter convalescence and cost effectiveness when compared to open procedures. Laparoscopic hysterectomies (both total and vaginally assisted) can lead to discomfort which may lead to a delay in discharge from hospital. Continuous infusions of local anaesthetic agents given post operatively to the site of operation have the been subject of trials for several operative procedures. To date however there have not been any properly controlled studies evaluating whether there are benefits of giving a local anaesthetic infusion for 48 hours into the pelvis following a total or vaginally assisted laparoscopic hysterectomy. The investigators therefore propose to investigate whether giving a local anaesthetic infusion in this fashion decreases the amount of rescue and patient controlled analgesia needed, and length of hospital stay. In order to do this the investigators wish to conduct a randomised placebo controlled double blind trial.


Eligibility Criteria:
Inclusion Criteria:

All women undergoing a total laparoscopic or laparoscopically assisted vaginal hysterectomy

Exclusion Criteria:

Women undergoing surgery for cancer, or are known to be allergic to local anaesthetic agents.
Safety and Efficacy Trial of AAV Gene Therapy in Patients With CNGB3 Achromatopsia (A Clarity Clinical Trial)

This will be a non-randomized, open-label, Phase 1/2 study of the safety and efficacy of AGTC-401 administered to one eye by subretinal injection in individuals with achromatopsia caused by mutations in the CNGB3 gene. The primary study endpoint will be safety and the secondary study endpoint will be efficacy.

This will be a non-randomized, open-label, Phase 1/2 study of the safety and efficacy of AGTC-401 administered to one eye by subretinal injection in individuals with achromatopsia caused by mutations in the CNGB3 gene. The primary study endpoint will be safety and the secondary study endpoint will be efficacy.

Subjects will be enrolled sequentially in seven dosing groups. Subjects in Groups 1, 2, 3, 4, 5, and 6 will be at least 18 years of age and will receive varying dose levels of study agent. Subjects in Group 4a will be 6 to 17 years of age and will receive the same dose as Group 4. Subjects in Groups 5a and 7 will be between 4 and 8 years of age. Subjects in Group 5a will receive the same dose as Group 5, and subjects in Group 7 will receive the maximum tolerated dose identified in Groups 1, 2, 3, 4, 4a, 5, 5a, and 6.

Safety will be monitored by evaluation of ocular and non-ocular adverse events and hematology and clinical chemistry parameters. Efficacy parameters will include visual acuity, light discomfort testing, color vision, static visual field, ERG, adaptive optics retinal imaging, functional MRI (fMRI), color brightness test and OCT.

Eligibility Criteria:
Inclusion Criteria include:

1. Male or female subjects with documented mutations in both alleles of the CNGB3 gene;
2. Retinal disease consistent with a clinical diagnosis of achromatopsia;
3. At least 18 years of age for Groups 1, 2, 3, 4, 5 and 6. At least 6 years of age for Group 4a, and 4-8 years of age for Groups 5a and 7;
4. Able to perform tests of visual and retinal function;
5. Visual acuity in the study eye not better than 55 ETDRS letters (Snellen equivalent 20/80) based on the average of two examinations at the baseline visit;
6. Acceptable laboratory parameters;
7. For females of childbearing potential: A negative pregnancy test within 2 days before administration of study agent.

Exclusion Criteria include:

1. Best-corrected visual acuity difference between the two eyes of \> 15 ETDRS letters (3 lines);
2. Evidence of degenerative myopia in the study eye;
3. Pre-existing eye conditions that would contribute to vision loss in either eye or increase the risk of subretinal injection in the study eye.