cyrilzakka/clinical-trials huggingface dataset:
Study of Atropine Therapeutic Effect on Myopic Progression

This study is to evaluate the therapeutic effect and safety of LPTAT in children with myopia.

The primary objective is to evaluate the superiority of LPTAT to placebo in slowing myopia progression through the change of SE(Spherical Equivalent), which is measured by cycloplegic autorefraction after 12-month treatment.

Eligibility Criteria:
Inclusion Criteria:

* Aged 5 to 12 years at the time of consent
* Refractive error of SE at least -1.0 D and no greater than -8.0 D in both eyes as measured by cycloplegic autorefraction at visit 1 and visit 2.
* Confirmed myopia progression of 0.5D or more within past 1year
* Astigmatism of 2.5D or less in both eyes
* Distance Best Corrective Visual Acuity to logMAR 0.2 or better in both eyes at visit1.
* Normal IOP under 21mmHg in both eyes.
* Anisometropia of SE less than 2.0D as measured by cycloplegic autorefraction at visit 1.
* Written informed consent willingly obtained by both subject and his/her parents

Exclusion Criteria:

* Hypersensitivity to atropine or other cycloplegic agent.
* History of the surgery of refractive correction
* Having ocular disease affect to visual function or refractive error: history of glaucoma, macula r degeneration, diabetic eye disease, uveitis, etc, or presence of conjunctivitis at screening visit.
* Having systemic diseases that affect to vision loss
* Having risk of IOP elevation such as narrow angle, Shallow Anterior Chambers, etc
* Presence of binocular function disorder or stereopsis disorder
* Amblyopia or manifest strabismus
* History of premature birth(less than 37weeks) or low birth weight(less than 2,500g)
* Previous or current use of atropine or Ortho-K lens for myopia
* Down syndrome, spastic paralysis, brain damage, spastic palsy, bladder
* Presence of neurological diseases like epilepsy, etc. which could expect difficulties in compliant to the ocular examinations.
* Presence of clinically significant cardiac and respiratory diseases
* Participation in any other clinical study of an investigational product within 3-month prior to current IP administration.
* Based on the investigator's discretion, subject who is not proper to participate in the trial.
Ethanol Lock for the Salvage of Infected Long-term Vascular Access

Long-term venous devices (e.g.Ports, tunneled catheters,...) may become infected. Sometimes it is very difficult to treat the infection and it is necessary to remove the device. The purpose of this study is to determine the efficacy of instilled ethanol ("ethanol lock therapy") versus instilled antibiotics ("antibiotic lock therapy") to save long-term venous device when infected, preventing their removal.


Eligibility Criteria:
Inclusion Criteria:

* Age: \>1 year and 10 Kgs
* Long-term vascular device in place at least for 7 days
* Catheter-related infection (at least presumed)
* Will to save the infected device (expected high risk access)

Exclusion Criteria:

* Known ethanol-allergy
* Known antabuse-like drugs in use
* Religious refusal
* S.aureus or Candida spp. as main pathogens (except in the unusual and documented scenarios when replacement of vascular access device proved to be very difficult)
* Tract or pocket infection
* Complicated infection (septic shock, infectious thrombosis, osteomyelitis, endocarditis)
Role of Serum Regucalcin in Diagnosis of Hepatocellular Carcinoma

Although the diagnosis and therapy of HCC have being improved, the poor prognosis still remains. To reduce the mortality and improve the effectiveness of diagnosis and therapy, it is important to detect the protein biomarkers which are associated with HCC tumor progression and may be useful as potential diagnosis or therapeutic targets.

SMP30 (senescence marker protein 30)(serum regucalcin), which we have previously identiﬁed from Guangxi HCC cDNA expression library by the SEREX approach, is one of the hepatocellular carcinoma associated antigens \[4\]

Serum antibody response to SMP30 in various patients using the methods of Western-blot and ELISA and showed that antibody to SMP30 existed mainly in HCC patients (39.8%), especially in the one with alpha-fetoprotein (AFP) negative


Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed cases of HCC (be based on NCCN guidelines triphasic CT and AFP or liver biopsy)
2. Adult patients
3. Both genders are eligible.
4. Informed consent obtained from subject or subject's legal representative

Exclusion Criteria:

1. Patient with other malignancies.
2. Patients with advanced comorbidities except for renal failure.
3. Prior chemotherapy
Extension Study to Assess Tolerability and Safety of Enteric-coated Mycophenolate Sodium in Renal Transplant Recipients Who Received Mycophenolate Mofetil

This extension study is considered to allow patients being treated with EC-MPS to collect further information on the long-term safety of this drug.


Eligibility Criteria:
Inclusion/ Exclusion criteria

- Only patients who were participating in study CERL080A2405-DE02 and have completed the first 6 months of the core study can be included in this additional extension study.

Other protocol-defined inclusion/exclusion criteria may apply.
Can Recombinant Human Intrinsic Factor Be Used for Evaluation of the Vitamin B12 Absorption?

Vitamin B12 is an essential nutrient for normal DNA-synthesis and must be supplied by animal products. Vitamin B12 deficiency may cause anemia and irreverible neurological damage. Laboratory tests are used for diagnosis of vitamin B12 deficiency, and following the diagnosis, the cause of the vitamin B12 deficiency has to be clarified. For years a test called Shilling's test has been used for evaluation of the vitamin B12 absorption. However, the Schilling's test is no longer easy accessible because of increasing difficulties to obtain the radioactively labeled vitamin B12 requested, and native human intrinsic factor for Schilling's test II (absorption of vitamin B12 attached to intrinsic factor) is no longer available in most countries. Recently, human intrinsic factor unsaturated with vitamin B12 has been expressed in the plant Arabidopsis thaliana. The purpose of this study was to examine whether recombinant human intrinsic factor is able to promote the uptake of vitamin B12 in patients with evident vitamin B12 deficiency.

Vitamin B12 is an essential nutrient for normal DNA-synthesis and must be supplied by animal products. Vitamin B12 deficiency may cause anemia and irreverible neurological damage. Laboratory tests are used for diagnosis of vitamin B12 deficiency, and following the diagnosis, the cause of the vitamin B12 deficiency has to be clarified. For years a test called Shilling's test has been used for evaluation of the vitamin B12 absorption. However, the Schilling's test is no longer easy accessible because of increasing difficulties to obtain the radioactively labeled vitamin B12 requested, and native human intrinsic factor for Schilling's test II (absorption of vitamin B12 attached to intrinsic factor) is no longer available in most countries. Recently, human intrinsic factor unsaturated with vitamin B12 has been expressed in the plant Arabidopsis thaliana. The purpose of this study was to examine whether recombinant human intrinsic factor is able to promote the uptake of vitamin B12 in patients with evident vitamin B12 deficiency.

Eligibility Criteria:
Inclusion Criteria:

Patients suspected to have vitamin B12 deficiency defined as a plasma vitamin B12 below the reference interval (\<200 pmol/L).

Exclusion Criteria:

Patients who were pregnant, nursing or not able to give written informed consent were excluded.
Laser Acupuncture and Acupressure for Low Back Pain

Background: Low back pain (LBP) is a common, huge health and socioeconomic health problem that affects physiological functions and reduces work efficiency in nurses.

Objective: This study aimed to evaluate the effect of low-level laser acupuncture combined with acupressure (LAA) on pain intensity, pain interference and life dysfunction in hospital nurses with LBP.

Methods: This single-blinded randomized controlled trial enrolled a convenience sample of nurses from one teaching hospital. Seventy-six participants were randomly assigned to the LAA group (n=38) receiving low-level laser acupuncture and auricular acupressure for four weeks, and a control group (n=38) receiving a similar intervention but without laser energy and acupressure. Data were collected using the Short Form of the Brief Pain Inventory (BPI-SF) and Roland-Morris Disability Questionnaire (RDQ) at three time points: baseline before the intervention, and Week 2 and Week 4 during the intervention.

The enrollment criteria were age more than 20 years, low back pain with visual analogue scale (LBP_VAS) ≧3, no regular treatment for low back pain within six weeks, and willing to participate in this study. Exclusion criteria were open wounds on lower back, tumor on the back, ankylosing spondylitis, previous lumbar surgery, coagulopathy or bleeding tendency, or pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* age more than 20 years, low back pain with visual analogue scale (LBP_VAS) ≧3
* no regular treatment for low back pain within six weeks
* willing to participate in this study

Exclusion Criteria:

* open wounds on lower back
* tumor on the back
* ankylosing spondylitis
* previous lumbar surgery
* coagulopathy or bleeding tendency
* pregnancy
Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo

This is multicenter, randomised, placebo controlled, parallel, double blinded , superiority clinical study comparing ozenoxacin cream versus placebo, in patients with a clinical diagnosis of non-bullous or bullous impetigo.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of bullous or non bullous impetigo. The patient has a total affected area comprised between 1-100 cm2 with surrounding erythema not extending more than 2 cm from the edge of any affected area. In case of multiple affected areas the total area will be the sum of each affected area and will not exceed 100 cm2. Additionally for patients \< 12 years the total area will not exceed a maximum of 2% of the body surface area.
* Total Skin Infection Rating Scale (SIRS) score of at least 3, including pus/exudate score of at least 1

Exclusion Criteria:

* Has a bacterial infection, which in the opinion of the investigator, could not be appropriately treated by a topical antibiotic.
* Has systemic signs and symptoms of infection (e.g. a fever; defined as an axillary temperature over 37.2 °C (99.0 °F)
Effects of Postoperative Pain Management on Immune Function After Laparoscopic Resection of Colorectal Cancer

The purpose of this study is to compare postoperative immune function (e.g. NK cell activity) of fentanyl-based analgesic regimen versus local anesthetic wound infiltration-based anlagesic regimen after laparoscopic colorectal surgery


Eligibility Criteria:
Inclusion Criteria:

* ASA class I-III
* 20-80 years old
* elective laparoscopic colorectal surgery for cancer

Exclusion Criteria:

* drug allergy
* significant renal or hepatic impairment
* sign of infection
Acceptability of an Out-patient Regimen of Medical Abortion With Mifepristone and 800 Mcg Misoprostol Administered at 78-84 Days Gestation

These pilot studies are designed as open label studies to investigate the acceptability of 200 mg mifepristone followed 24-48 hours later by either 1) 800 µg misoprostol administered buccally or 2) 800 µg misoprostol administered sublingually for medical abortion in gestations 78-84 days' LMP. They will be done consecutively.

Findings from the pilot studies will guide the development of a larger, multi-site study to investigate the efficacy of outpatient medical abortion regimens for women with gestations from 78 - 84 days LMP. In that end, the pilots seek to collect information on the acceptability of an outpatient medical abortion regimen of 200 mg oral mifepristone followed by either 800 mcg misoprostol delivered either buccally or sublingually safe acceptable? Women's rating of the tolerability of any side effects will also be documented.


Eligibility Criteria:
Inclusion Criteria:

* Seeking abortion services
* Have an intrauterine pregnancy 78 days through 84 days' LMP
* Be willing and able to sign consent forms
* Agree to comply with study procedures and visit schedule
* Be living with 30 minutes from the hospital

Exclusion Criteria:

* Does not meet the inclusion criteria outlined above
Efficacy and Safety of MP-513 in Combination With Metformin in Patients With Type 2 Diabetes

The purpose of this study is to evaluate the safety and efficacy of MP-513 in combination with Metformin in patients with type 2 diabetes for 24 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with Metformin with an extension treatment for up to 52 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are aged ≧ 18 years old.
* Patients whose HbA1c is ≧ 7.0 % and \< 10.0%.
* Patients whose BMI is ≧ 20.0 and ≦40.0 ㎏/㎡.
* Patients who took metformin monotherapy for at least 56 consecutive days at the screening visit.

Exclusion Criteria:

* Patients with type 1 diabetes or secondary form of diabetes.
* Patients with heart failure symptoms.
* Patients with serious diabetic complications.
* Patients with severe hepatic disorder or severe renal disorder.
* Patients who are the excessive alcohol addicts.
* Patients who are pregnant, lactating and probably pregnant patients and patients who can not agree to contraception.
Resilience and Mentoring in German-speaking Intensive Care Providers and Anesthesiologists

The aim of this study is to identify factors influencing work engagement and wellbeing in German-speaking intensive-care providers and anesthesiologists.


Eligibility Criteria:
Inclusion Criteria:

* resident or staff anesthetist
* since more than 6 months working for the same institution

Exclusion Criteria:

* no informed-consent
Safety and Performance Study of the Nyxoah SAT System for Treating OSA

A prospective open-label, single treatment study to assess the safety and the performance of the Nyxoah SAT system for the treatment of Obstructive Sleep Apnea


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with moderate to severe Obstructive Sleep Apnea
* Have failed or have not tolerated CPAP treatment
* Willing and capable of providing informed consent
* Willing and capable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires

Exclusion Criteria:

* BMI limits
* Subjects with complete concentric collapse at the soft palate level per endoscopy
Head Pulse for Ischemic Stroke Detection

Accurate diagnosis of stroke due to large vessel occlusion (LVO) is an essential step in providing acute stroke care to a community. The gold-standard for diagnosis LVO is brain imaging, which is impractical in the pre-hospital setting. A non-invasive method to detect LVO is needed. Using highly sensitive accelerometers, one can measure the "HeadPulse"- tiny forces exerted on the skull from the cardiac contraction. This study tests the hypothesis that LVO alters the HeadPulse characteristically. Analysis of these data along with the subjects vascular status (LVO vs. non-LVO as measured by CT angiography) will be used to create a model that can predict LVO status in suspect stroke subjects.

Large vessel occlusion (LVO) ischemic stroke is a treatable disease at specialized centers. Clinical outcomes of patients with LVO is time-dependent. To maximize clinical benefit of thrombectomy, stroke systems of care need accurate methods to triage patients with LVO to comprehensive stroke centers or thrombectomy ready centers rather than closer primary stroke centers.

EPISODE will evaluate whether measurements of the HeadPulse can predict the presence or absence of LVO based on recordings from a consecutive series of patients undergoing CTA for suspected stroke. Recordings from patients pre- and post-thrombectomy will also be compared to investigate whether a systematic change in cranial forces exists during LVO.

Eligibility Criteria:
Inclusion Criteria:

* Suspected acute stroke
* CTA or MRA performed

Exclusion Criteria:

* Any patient in whom obtaining a non-invasive recording is judged by the treating team to interfere with clinical assessment or treatment of the patient.
Bioequivalence of Metformin Under Fed Conditions After Administration of Linagliptin / Metformin Fixed Dose Combination Tablet and Single Tablets

To establish bioequivalence (BE) under fed conditions between metformin in linagliptin/metformin fixed dose combination tablet and metformin reference product administered in free combination togther with linagliptin


Eligibility Criteria:
Inclusion criteria:

1. Healthy male and female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions
Peak Study - A Study of Pegasys (Peginterferon Alfa-2a (40KD)) in Combination With Copegus (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC).

This study will examine the viral kinetics and pharmacokinetics of Pegasys plus ribavirin and PEG-Intron plus ribavirin in interferon-naive patients with CHC. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients at least 18 years of age
* CHC infection, genotype 1
* use of 2 forms of contraception during study in both men and women

Exclusion Criteria:

* previous systemic therapy with anti-viral, anti-neoplastic, or immunomodulatory agents
* medical condition associated with chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposure)
* decompensated liver disease
* women who are pregnant or breastfeeding
12 Week Evaluation of the Safety and Efficacy of 4 Dosing Strategies of CP-526,555 and Placebo for Smoking Cessation.

The purpose of the study is to measure the safety and efficacy of four dosing strategies of CP-526,555 for 12 weeks compared with placebo for smoking cessation. Post-treatment follow-up of smoking status to one year from randomization was performed in a non-treatment extension Protocol A3051018


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have smoked on average of at least ten cigarettes per day during the past year
* Subjects must have no period of abstinence greater than three months in the past year

Exclusion Criteria:

* Subjects with any history of clinically significant cardiovascular disease
* Uncontrolled hypertension
Study of a Novel Non-invasive Glucose Monitoring Device

This explorative clinical study has been launched to collect spectral Raman data paired with validated glucose reference values in diabetic patients.

The Investigational Medical Device (IMD) for this investigation is the Prototype 0.5 (P0.5) developed and manufactured by RSP Systems (RSP). The device is intended for non-invasive interstitial intermittent glucose monitoring in persons (age 18 and older) with diabetes. The technology relies on the well-established capacities of Raman spectroscopy for directly detecting glucose subcutaneously. The Raman spectroscopy physical principle relies on the fact that when laser light of a given wavelength interferes with a molecule, a small fraction of the incident light will interact with the vibrational states of the molecule, causing the photons to lose a portion of their energy which will change the wavelength of the light. The scattered light will be collected by the optical probe head and analyzed with advanced algorithms to correlate the signal to glucose concentrations. Data collected from the IMD will be paired with validated glucose reference values collected by the finger sticking method.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects ≥18 years of age
* Diagnosed with diabetes, all types except gestational diabetes
* HbA1c distribution \> 60 mmol/mol at baseline visit
* Skin phototype 1-4
* Willing to perform a minimum of 8 finger sticks during each day of home-based measurements and 30 finger sticks at the two in-clinic study days
* Subject has a wireless internet connection at home to be used in the study

Exclusion Criteria:

* For female subjects: Pregnancy or subject is attempting to conceive or not willing and able to practice birth control during the study duration
* For female subjects: Breastfeeding
* Subject currently participating in another study
* Subject not able to understand and read Danish
* In investigator's opinion, subject is not able to follow instructions provided and as specified in the protocol
* Subject not able to hold hand/arm steady (including tremors and Parkinson's Disease)
* Reduced circulation in right hand evaluated by Allen's test
* Extensive skin changes, tattoos or diseases on right hand thenar (probe application site)
* Known allergy to medical grade alcohol used to clean the skin
* Medical history or any condition that may, in the opinion of the investigator compromise the subject's ability to participate
* Comorbidity or concomitant medical condition which, in the opinion of the Investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff
Clinical Follow-up and Outcomes of Pregnancies Exposed to Ella

The study is aimed at assessing the clinical follow-up and the outcomes of pregnancies exposed to ella, whether due to failure of the emergency contraception or inadvertent exposure during pregnancy.


Eligibility Criteria:
* Pregnant women, exposed to ella during the menstrual cycle in which the pregnancy started (treatment failure) or at any time during pregnancy (inadvertent exposure during pregnancy)
* Adolescents and/or adults in the USA, depending on the respective State law
Neuro-Orthopedic Registry of the University Hospital of Toulouse

Neuro-orthopedics corresponds to the evaluation and therapeutic management of the orthopedic consequences of damage to the central or peripheral nervous system. In case of neurological impairment, there may be joint, motor, sensory and cognitive impairments that limit the patient's activities. The management of these orthopedic problems falls within the specific framework of neuro-orthopedics because in the presence of neurological, problems are different and more complex than in classical orthopedics. In this context, a well-conducted evaluation is a prerequisite for appropriate treatment.


Eligibility Criteria:
Inclusion Criteria:

Patient with a neurological condition that benefits:

* An injection of botulinum toxin in the context of spasticity : about 20 / week
* Pre or post-therapeutic clinical evaluation (botulinum toxin or surgery): approximately 10 / week
* Clinical or instrumental evaluation of the walking or upper limb (Physiological Functional Explorations): about 10 / week
* A medical and surgical multidisciplinary consultation about spasticity : about 15 / month
* A discussion during neuroorthopedic multidisciplinary consultation meeting about the patient's file and anomalies of walking: about 8 / month
* Implementation of a Baclofen pump (Neurosurgery): about 2 / month
* Functional surgery of the upper or lower limb (locomotor institute, orthopedic surgery and traumatology): about 4 / sem

Exclusion Criteria:

Patient (or the legal representative) who opposes the data collection.