cyrilzakka/clinical-trials huggingface dataset:
Long-term Study With Clevudine

A open-labeled phase lV study with 96 weeks of treatment period. The purpose of this study is to investigate safety and efficacy of clevudine in patients chronically infected with hepatitis B virus, HBeAg positive or negative.


Eligibility Criteria:
Inclusion Criteria

* Patient with DNA levels \>=1 x 10\^5 copies/mL within 30 days of baseline.
* Patient is documented to be HBsAg positive for \> 6 months.
* Patient has ALT levels \>=80 IU/L
* Women of childbearing potential must have a negative urine (β-HCG) pregnancy test taken within 14 days of starting therapy.

Exclusion Criteria.

* Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
* Patients previously treated with interferon within the previous 6 months.
* Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.
* Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
* Patient is coinfected with HCV, HDV or HIV.
* Patient with clinical evidence of decompensated liver disease or hepatocellular carcinoma
* Patient is pregnant or breast-feeding.
* Patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases.
* Patient has a clinically relevant history of abuse of alcohol or drugs.
* Patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic(except HCC)or allergic disease or medical illness that in the investigator's opinion might interfere with therapy.
* Patient has creatinine clearance less than 60mL/min as estimated by the following formula: (140-age in years) (body weight \[kg\])/(72) (serum creatinine \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]
Non-Interventional, Postmarketing Surveillance Study of Nusinersen Sodium Injection

The primary objective of this study is to evaluate the safety of nusinersen sodium injection in the postmarketing setting in China.The secondary objectives are to collect data on the efficacy and the pharmacokinetics of nusinersen sodium injection in the post-marketing setting in China.


Eligibility Criteria:
Key Inclusion Criteria:

* Ability of the participant or his/her legally authorized representative (e.g., parent or legal guardian), as appropriate and applicable, to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations.
* The decision to newly prescribe nusinersen sodium injection according to the local marketing authorization, including documentation of 5q SMA diagnosis, has been made by the Investigator and agreed to by the participant (or legally authorized representative)

Key Exclusion Criteria:

* Hypersensitivity to the active substance or any of the excipients of nusinersen sodium injection.
* Current or past administration of nusinersen sodium injection, in either a commercial or a clinical study setting.
* Other unspecified reasons that, in the opinion of the Investigator or the Sponsor, make the participant unsuitable for enrollment.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Amino Acid and Acylcarnitine Profiles in Premature Neonates

Primary Hypotheses of the study include:

* Metabolic profiles are influenced by gestational age, chronological age, type and degree of nutritional support and illness
* Metabolic profiles differ between neonates who receive commercial formula and neonates who receive primarily human breast milk
* Neonates who develop parenteral associated cholestasis have metabolic markers that identify at risk patients (high serum urea nitrogen, citrulline, histidine, methionine, and succinyl carnitine and low thyroxine, serine and glutamate)
* Neonates that have hypothyroidism have abnormal metabolic profiles (low tyrosine levels)

Malnutrition is a common problem in the neonatal intensive care unit. Recent studies indicate that prematurely born neonates commonly develop a severe nutritional deficit during the first weeks after birth, referred to as extrauterine growth restriction. Despite an increase in growth during the second month of hospitalization, many neonates are ultimately discharged home having grown inadequately. The early nutritional deficit affects weight gain as well as growth in length and head circumference. Aggressive administration of parenteral amino acids to improve protein accretion rates in very preterm neonates has been supported in the literature. Although tolerance of high dose amino acids has been described, researchers acknowledge that sensitive tests to monitor amino acid toxicity are not readily available in the clinical setting.

The goals of this study are:

* To better define normal amino acid and acylcarnitine values and how they change in premature neonates
* To measure the effect nutritional support has (human breastmilk vs. formula) on amino acid and acylcarnitines profiles
* To measure the effect of illness (parenteral nutrition associated cholestasis) on amino acid and acylcarnitine profiles
* To better define abnormal metabolic profiles (low tyrosine levels) in neonates that have hypothyroidism.

Eligibility Criteria:
Inclusion Criteria

* Documentation of informed consent
* Inborn
* Less than or equal to twenty four (24) hours of age
* Gestational age between twenty three (23) weeks and 0/7 days and thirty one (31) weeks and 0/7 days as per the best estimate by the neonatologist
* If subject is transferred to another hospital, the ability to obtain follow-up data on outcomes
* No known major anomalies (inborn error of metabolism, chromosomal abnormalities, cyanotic congenital heart disease, gastroschisis, omphalocele, diaphragmatic hernia or other major gastrointestinal anomalies, major neurological injury or anomaly, and multiple congenital anomalies)

Exclusion Criteria

* Outborn (transferred for intensive care from another hospital)
* Greater than twenty four (24) hours of age
* Gestational age \< 23 weeks or \> 31 weeks
* Any known major congenital anomalies
Clinical Trial to Evaluate the Safety and Efficacy of Scarclinic™ Thin in Surgical Scars

Compare the efficacy and safety of Scarclinic™Thin and Scarclinic™ Normal for the treatment of surgical scars.

Participant: 40 Treatment period : 3 months Medical device: Scarclinic™Thin , Scarclinic™ Normal Randomization: Table of random number

For evaluating the efficacy

* The investigator check Vancouver Scar Scale at 1 and 3 month after application to evaluate vascularity, pigmentation, elasticity, height, pain and itchiness
* The participant filled out survey included questions regarding convenience in use at 1 and 3 month after application.

Eligibility Criteria:
Inclusion Criteria:

* Patient who aged more than 18 years and less 55 years
* Patient who has a surgical scar that is not over 3 months after the surgery
* Patient who sign informed consent form for the study

Exclusion Criteria:

* need wound dressing for exudate
* wound infection
* general malaise
* history of mental disorders
* taking anticancer drugs or antiphlogistics or steroid
4Kscore Using Serum Stored Uncentrifuged

The purpose of the study is to evaluate whether storage of serum uncentrifuged is an allowable preanalytical procedure


Eligibility Criteria:
Inclusion Criteria:

* Men capable of donating five 5 mL tubes of whole blood
* 40 to 80 years old
* No prior diagnosis of prostate cancer; prior negative prostate biopsy included
* Total PSA (tPSA) value measured within last year to be: at 1.5 ng/mL to 4 ng/mL, 4.1 ng/mL to 10 ng/mL and 10 ng/mL and above

Exclusion Criteria:

* In the previous 96 hours (4 days), underwent a digital rectal exam
* Any invasive urologic procedure in the 6 months prior to study participation
* Underwent any procedure to treat symptomatic benign prostatic hyperplasia in the last 6 months
* Radical prostatectomy since tPSA measurement
* Received within the previous 6 months 5-alpha reductase inhibitor (5-ARI) therapy such as Avodart (dutasteride) or Proscar (finasteride)
Laser Treatment in Early Wound Healing to Promote Physiological Skin Remodeling

The primary objective of this study is to explore the potential clinical effect of targeting surgical wounds in all three wound healing phases by non ablative fractional laser (NAFL) to reduce scar formation in a randomized controlled trial. Thus, NAFL will be applied during 1) inflammation phase (0-3 days) as represented by NAFL-treatment adjacent to surgical wounding, 2) proliferation phase (4-21 days) by NAFL-treatment immediately after suture removal and 3) remodeling phase (21 days-1 year) by NAFL-treatment six weeks after surgery.

This is a prospective, randomized, controlled, assessor - blinded, intra-individual trial comparing laser exposed skin lesions to untreated control skin lesions in a split scar set-up to investigate efficacy. The study will be performed on patients undergoing an excision at Bispebjerg Dermatological Department. One randomly allocated part of each included wound will receive three NAFL-treatments and the other part will serve as untreated control wound. Scars will be evaluated clinically on-site by blinded evaluator immediately before third treatment and 3 months after NAFL-treatments. The clinical data will be supplemented by blinded photo-evaluation, patients' evaluation and non-invasive measurements.

Eligibility Criteria:
Inclusion Criteria:

* o Subjects referred to excision of either benign, pre malignant or malignant non-melanoma skin cancer (NMSC) lesions.

  * The length of postoperative wound should be estimated to minimum 2.5 cm and may be located on any region of the body
  * Minimum 18 years old
  * Presenting full medical record report at study initiation
  * Fitzpatrick skin type I-III
  * Non-smokers
  * Written informed consent obtained from subject
  * Understanding of investigation procedures and willingness to abide to all procedures during the course of the investigation

Exclusion Criteria:

* o History of or presenting with a keloid scar

  * A subject with a systemic disease not yet stabilized
  * If the patient is pregnant
  * Visible recent sun exposure in test area
  * Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study
  * Current use of topical treatment and lack of willingness to refrain from future use of topical treatment, such as i.e. silicone products, that potentially can interfere with the test results
  * Unable to follow the outlined study protocol
Study of Cefditoren Pivoxil in Treatment of Childhood With Acute Rhinosinusitis

Cefditoren pivoxil has been used in rhinosinusitis treatment. However, little is known about the efficacy of this drug at low and high doses.

The investigation was a randomized, investigator-blinded, and parallel study, conducted in patients (age 1-15 years) with acute rhinosinusitis. Two groups of patients were randomized received low (10 MKD) or high (20 MKD) of drug for 14 days. Changes in sinus symptoms scores, response rate and adverse effect were evaluated at days 7 and 14. Relapse rate was recorded at days 21 and 28. Recurrence of sinus symptoms at day 60 were assessed.

Eligibility Criteria:
Inclusion Criteria:

* children age 1-15 years old diagnosed acute rhinosinusitis

Exclusion Criteria:

* poor compliance
* other infections
Keto Drinks as a Meal Primer in Patients With Type 2 Diabetes

The main objective of this clinical trial is to study the effects of orally administered ketone drinks containing the ketone body, 3-hydroxybutyrate (3-OHB), just before a meal in patients with type 2 diabetes. Moreover the investigators will compare the effects of two different ketone drinks.

The hypothesis is:

3-OHB as a pre-meal may:

* Lower postprandial blood glucose and lipids.
* Mediate release of intestinal hormones and affect gastric emptying.
* Affect appetite and other subjective measures related to food intake.

The effects of 3-OHB as a pre-meal will be investigated by blood samples, isotopic tracers examinations, paracetamol test, questionnaires and meal test.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes diagnosis, metformin treated or dietary treated
* HbA1C \< 80 mmol/mol
* 25 \< BMI \< 35
* Written consent

Exclusion Criteria:

* Severe comorbidity
* Treatment with insulin, GLP-1 analogues, SGLT-2-inhibitors or sulfonylureas
* Specific diets, e.g. ketogenic diet
* PI finds the patient not fit (e.g. mental illness, too nervous, unacceptable screening blood tests or other)
MRI Assessment of Patient Suitability for Cardiac Resynchronization Therapy (CRT)

The goals of this project are to: 1) explore the potential use of magnetic resonance imaging (MRI) data for improved prediction of response to cardiac resynchronization (CRT), and 2) use the MRI-derived data together with a computer model of the cardiovascular system to study the relative roles of different factors in the mechanical effects of dyssynchrony in failure, and in the response (or lack thereof) to CRT.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients ages 18 and over scheduled by conventional criteria (symptomatic impairment of cardiac function with broadened QRS) for clinical CRT procedures at NYULMC.
* Normal kidney function as determined by GFR levels.

Inclusion Criteria for Controls

* Normal kidney function as determined by GFR levels
* No significant cardiovascular disease or risk factors.

Exclusion Criteria:

* electrical implants such as cardiac pacemakers or perfusion pumps
* ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
* ferromagnetic objects such as jewelry or metal clips in clothing (which will be removed)
* pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest.
Meditation as Complementary Treatment for Chronic Hypertension in Pregnancy

Pregnancy relates to arterial hypertension; it is an aggravating factor for pre-existing chronic arterial hypertension or a trigger for preeclampsia in normotensive women. The gestational hypertensive disease is managed conventionally with the pregnant woman's hospitalization and/or the use of antihypertensive medications. Nevertheless, this treatment may present some risks. The investigators seek to determine whether the intervention compared to the control can reduce the increase in blood pressure that pregnant women in the transition from the 2nd to the 3rd trimester.

Primary research question:

Can meditation decrease the mean increase in diastolic blood pressure in pregnant hypertensive women at the transition from the second to the third trimester of gestation?

Secondary research question:

Can meditation decrease the mean increase in systolic blood pressure in pregnant hypertensive women at the transition from the second to the third trimester of gestation?

Does meditation practice increases (or decreases) the likelihood of change in Resilience indicators?

Does meditation practice increase (or decrease) the likelihood of change in anxiety and depression indicators?

Does meditation practice increase (or decrease) the likelihood of change in mindfulness indicators?

Does meditation practice increase (or decrease) the likelihood of change in quality of life indicators?

Eligibility Criteria:
Inclusion Criteria:

1. Pre-existing hypertension.
2. Single pregnancy, with gestational age between 20th and 24th weeks, with uncomplicated systemic arterial hypertension.
3. Prenatal follow-up in a high-risk pregnancy clinic.
4. No personal background of depression or psychiatric disorders.
5. No serious heart disease.
6. No illicit drugs and/or alcohol use.
7. Acceptance of the informed consent.
8. To follow the practice used in the study, the subjects are required to have an available phone in order to download an app which contains an audio guide for this purpose.

Exclusion Criteria:

1. Diagnosis of depression and psychiatric disorders during pregnancy.
2. Patients who do not return to follow-up or who want to quit the study.
3. To practice meditation.
Psychometric Validation of the "Antillanisée" Version of the Mini Mental State Examination (MMSEa)

The main objective of the study is to analyze the psychometric properties of the "antillanisée" version of the Mini Mental State Examination (MMSEa).

The methodology used will permit to explore the feasibility, acceptability, validity and reliability of the tool.

The psychometric validation of a version adapted transculturally will increase the value of the results obtained with this test and will make it possible to refine the screening of existing cognitive disorders for elderly subjects with Alzheiner's disease or related disorders.

Patients will be recruited at the Geriatric Day Hospital.

These patients came to a geriatric day hospital for examination without restriction on the reason for the hospitalization.

They are referred by their general practitionner or referred by a specialist physician, live at home or in an institution and are representative of the geriatric population addressed by the MMSEa.

* The main objective of the study is to analyze the psychometric properties of the "antillanisée" version of the Mini Mental State Examination (MMSEa).
* The ancillary objective of this study will be to carry out the psychometric validation of the Short Physical Performance Battery (SPPB) in people aged 65 years or older.

It is an instrument for measuring the physical performance of subjects whose transcultural adaptation and psychometric validation have already been performed in subjects aged 65 to 74 years.

SPPB is used routinely in our routine practice in a day hospital, with no psychometric validation performed on this population. This ancillary objective will not modify the course of the MMSEa validation study since the SPPB is part of the evaluation tools.

Eligibility Criteria:
Inclusion Criteria:

* Subject of 65 years old and over
* Subject admitted in a geriatric day hospital
* Patients of creole culture
* Subject having French and/or Creole as mother tongue
* Subject able to undergo neuropsychological tests
* Subject having given informed consent or, informed consent given by his or her primary caregiver
* Subject affiliated to a social security scheme

Exclusion Criteria:

* Subject with a disability seriously compromising oral communication (understanding and expression)
* Subject with behavioral disorder that does not allow for testing
* Subject in general condition not allowing its participation in the tests
* Subject involved in another study including an exclusion period still in progress at the time of inclusion
Real World Registry Assessing the Clinical Use of the Bard UltraScore Forced Focus PTA Balloon

The objective of this study is to assess the clinical use of the Bard® UltraScore™ Focused Force PTA balloon in a heterogeneous patient population in a real world, on-label clinical application.

The registry is a prospective, multi-center, single-arm, real-world study to assess the clinical use of the Bard® UltraScore™ Focused Force PTA balloon for the treatment of stenotic lesions of the superficial femoral artery (SFA), popliteal artery, and infra-popliteal arteries (posterior tibial, anterior tibial and peroneal arteries). Follow-up for all treated subjects will be performed at hospital discharge, 30 days, and 6 and 12 months post-index procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures.
2. Subject must be either a male or non-pregnant female ≥ 21 years of age with an expected lifespan sufficient to allow for completion of all study procedures.
3. Subject must be willing to comply with the protocol requirements, including the follow-up procedures.
4. Subject must have a target lesion (de novo lesion or prior failed treatment) that can be treated with the UltraScore™ Focused Force PTA balloon according to the Instructions for Use (IFU). Only a target lesion in the SFA, popliteal, or infra-popliteal arteries (posterior tibial, anterior tibial, or peroneal arteries) may be treated for this study.
5. Subject must have an Above the Knee (ATK) or Below the Knee (BTK) target lesion with at least one vessel run-off.
6. The target lesion must be able to be crossed using a guidewire (use of chronic total occlusion (CTO) or atherectomy is allowed).

Exclusion Criteria:

1. Subjects that are to receive one or more stents as adjunctive therapy at the target lesion (bail out stenting is allowed).
2. The subject has a single target lesion that involves both ATK and BTK arteries.
3. The subject has a target lesion in a previously placed stent or stent graft (in-stent restenosis).
4. The subject has a lesion, which in the opinion of the Investigator, would preclude safe use of the UltraScore™ Focused Force PTA balloon.
5. The subject has a flow limiting dissection at the target lesion prior to use of the UltraScore™ Focused Force PTA balloon.
6. The subject has acute limb ischemia.
7. The subject has been assessed Rutherford category 6.
8. The subject has a known allergy or sensitivity to contrast media, which cannot be adequately pre-medicated.
9. The subject has another medical condition or is currently participating in an investigational drug or another device study that, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up.
Effects of Singing in Chronic Obstructive Pulmonary Disease

The purpose of this study is to investigate the effects of the practice of singing for a long period of time on pulmonary function data, quality of life, and dyspnea sensation of patients with COPD in stable clinical conditions. As singing is a type of respiratory training, the study hypothesis is that singing would improve maximal respiratory pressures, dyspnea sensation, and overall quality of life of these patients.

Thirty COPD patients in stable clinical conditions are going to be randomized in two groups: the first one is going to have singing classes for six months; the other one is going to have classes of general manual arts for a similar period of time. The patients of both groups are going to perform spirometry, measurements of maximal respiratory pressures and answer the health related quality of life questionnaires SF-36 and Saint George's before the beginning of practice and after 6 months.Both singing and manual arts practices are going to be administered one hour a week by specialized teachers.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD according GOLD criteria
* Stable clinical conditions for the previous two months

Exclusion Criteria:

* Severe comorbidities other than COPD
* Hypoxemia with partial arterial oxygen pressure lower than 50 mmHg
* Incapacity to come to the research center in a weekly basis.