cyrilzakka/clinical-trials huggingface dataset:
A Bioequivalence Study of Domestic (Made in China) and Imported Mizolastine Tablets in Healthy Volunteers

The purpose of the study is to evaluate the bioequivalence (the way in which different forms of the same drug are absorbed in the body) of single-dose administration of domestic (made in China) mizolastine tablets and imported mizolastine tablets given at the same dose in healthy volunteers

This is a single-center, open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), crossover (method used to switch patients from one treatment arm to another in a clinical study) study. Approximately, 24 healthy volunteers will be enrolled in the study. Eligible volunteers will be randomly allocated to either Sequence A group or Sequence B group. On Day 1, volunteers from Sequence A group will receive imported mizolastine tablets and volunteers from Sequence B group will receive domestic mizolastine tablets. There will be a washout period (no treatment) of 7 Days. On Day 8, the two sequence groups will be switched. Volunteers from Sequence A group will receive domestic mizolastine and volunteers from Sequence B group will receive imported mizolastine tablets. Safety evaluations will include assessments of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination, which will be measured throughout the study. The maximum study duration for each volunteer will be approximately 16 days.

Eligibility Criteria:
Inclusion Criteria:

* No history of smoking
* Body mass index between 18 and 28 kilogram per square meter
* Health status considered good by the investigator according to physical examination, medical history, vital signs, electrocardiogram and clinical laboratory results
* Must be able to read and understand the informed consent form and sign the informed consent form before carrying out any operation related to the study

Exclusion Criteria:

* Health examination does not comply with the inclusion criteria
* Serious alcohol abuse
* Known allergy to active ingredients or excipients
* Habitual use of any drug including Chinese medicine
Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) in Japanese Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection

This is a phase 3, double-blinded, multicenter study. The study will consist of 2 substudies: Substudy 1 (SS1) will be double-blinded and enroll non-cirrhotic subjects and Substudy 2 (SS2) will be open label and enroll subjects with compensated cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* Chronic HCV-infection prior to study enrollment
* Screening laboratory result indicating HCV subgenotype 1b infection
* Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening
* Voluntarily sign an informed consent
* Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile

Exclusion Criteria:

* Co-infection of Hepatitis B Virus (HBV), human immunodeficiency virus (HIV) or any HCV genotype other than subgenotype 1b
* Prior therapy with direct acting antiviral agents for the treatment of HCV, including telaprevir, simeprevir and boceprevir
* Any cause of liver disease other than chronic HCV-infection, including but not limited to the following: hemochromatosis; alpha-1 antitrypsin deficiency; Wilson's disease; autoimmune hepatitis; alcoholic liver disease; drug-related liver disease; clinically significant laboratory abnormalities; uncontrolled clinically significant disease, disorder or medical illness
Comparision of Different Methods of Enviromennt Disinfection

Multidrug resistance bacteria infection is common in ICU. Infection incidence is associated with age, organ dysfunction, invasive treatment and enviroment cleaning. According to hospital hygienic standard for disinfection, total numbers of colony of air and the object surface in ICU must be ≤4CFU/cm2（5min）and≤10CFU/cm2. in this study, the two different methods will be used to evaluate the disinfection effects in ICU enviroments.


Eligibility Criteria:
Inclusion Criteria:

no patients recruitment

Exclusion Criteria:

no patients recruitment
Implications of Biological and Procedural Factors of 18-f FDG Uptake by Normal Organs and Neoplastic Lesions

To evaluate implications of biological and procedural factors of 18-f FDG PET/CT uptake on normal organs and neoplastic lesions.

18-f FDG is used on oncological patients undergoing PET/CT study at our nuclear medicine unit , its uptake by the tissues depends on glucose blood level and consumption then we evaluate the implications of biological and procedural factors on the uptake by normal organs and neoplastic lesions using standardized uptake values SUVmax , mean and peak.

Eligibility Criteria:
Inclusion Criteria:

* cancer patients referred to nuclear medicine unit

Exclusion Criteria:

* patients with increased FDG uptake associated with non malignant causes such as diffuse bone marrow FDG uptake or lung infection or patients with extensive metastasis in target organs
Comparison of Efficacy of Less Invasive Surfactant Treatment Under Nasal CPAP and Nasal IPPV

Non invasive ventilation is important in the care of preterm infants with respiratory failure, and surfactant treatment can be use with non invasive ventilation. However, there is no consensus on the best non-invasive ventilation mode for surfactant treatment in preterm infants.

Objective: To compare the effectiveness of nasal intermittent positive pressure ventilation (NIPPV) versus nasal continuous positive airway pressure (CPAP) in preterm infants ≤ 29 week gestational age.

This CURLISPAP study was a multicenter, randomized controlled study at six level III neonatal intensive care units (NICUs) in Turkey. The protocol was approved by the ethics committee of each participating centre and Turkish Ministry of Health, Turkish Medicines and Medical Devices Agency.

Non invasive ventilated preterm infants with respiratory distress syndrome and gestational age from 241/7 weeks to 296/7 weeks were enrolled within 6 h of birth. Infants with major congenital malformations, need of mechanical ventiation, need of entubation in delivery room and lack of parental consent were excluded. Enrolled infants will randomize into two study groups (NIPPV group and CPAP group). The short binasal prongs will use as interface. For all the groups, if the fraction of inspired oxygen (FiO2) requirement is persistently higher than 0.30 target SpO2 90-94%.

For all groups Surfactant by "LISA" technique and with special catheter (LISAcath, Chiesi Pharmaceutics) of surfactant (Curosurf, Chiesi Pharmaceutics) 200 mg/kg.

The primary end-point, need of mechanical ventilation within 72 hours following surfactant treatment, will compared between the groups. Short and long-term neonatal outcomes will also evaluate.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age 24 -29 week
* Clinical and radiological diagnosis of RDS
* Born in a hospital with a study center
* Spontaneous breathing
* Within the first 6 hours
* Non-invasive ventilation and FiO2 requirement \>0.30
* Parental concent

Exclusion Criteria:

* Major congenital malformations
* Need of mechanical ventiation
* Need of entubation in delivery room
* Air weak syndrome
* No parental concent
Stratified vs Routine Prophylaxis in Living Kidney Transplantation From HBsAg+ Donors to HBsAg- Recipients

This is a multicenter, prospective, observational study to compare the efficacy and safety of stratified prophylaxis based on donors' and recipients' risk factors vs routine prophylaxis bases on clinical experience in living kidney transplantation from HBsAg+ donors to HBsAg- recipients. The follow-up period was 2 years after renal transplantation. The primary outcome was prevention failure of HBV transmission (any one of HBsAg - → +, HBV DNA - → +, HBeAg - → +, HBeAb - → +, HBcAb - → +, active liver function damage and death in the recipient).


Eligibility Criteria:
Inclusion Criteria:

1. patients diagnosed with end-stage renal diseases and suitable for living kidney transplantation;
2. HBsAg+ donor was the only donor;
3. age and sex of donors and recipients were unrestricted;
4. ABO compatible or incompatible between the donor and recipient;
5. The living donor voluntarily donates one of their kidneys to the recipient free of charge;
6. The donor and recipient can understand the purpose and risk of living KT and sign informed consent;
7. Ethics committee approved.

Exclusion Criteria:

1. preoperative abnormal liver dysfunction in the donor or recipient (ALT \> 60IU/L for females, and \>75 IU/L for males; or total bilirubin \> 34 umol/L); or preoperative ultrasonography in the donor or recipient reported hepatic cirrhosis;
2. positive complement-dependent cytotoxicity cross-match test;
3. combined HCV or HIV infection in the donor or recipient;
4. diagnosed with malignancy or had a history of malignancy in the past 5 years;
5. non-kidney transplantation history.
Early Retinal Nerve Fiber Layer Change of Ethambutol Optic Neuropathy by Optical Coherence Tomography

Ethambutol is widely used as first-line drug, but has serious side effect of optic neuropathy. As previously reported, incidence of ethambutol optic neuropathy is about 1\~2%, there was considerable screening efforts and medical cost is increasing. However, there is no effective treatment of ethambutol optic neuropathy or no definite preventable measure. Moreover, multi-drug resistance tuberculosis or extensively drug resistance tuberculosis is emerging, more toxic secondary drug is used in the long-term.

It is known that retinal nerve fiber layer is increased early stage in ethambutol optic neuropathy. So we decide to evaluate the retinal nerve fiber layer thickness measured by optical coherence tomography in longitudinal manner.


Eligibility Criteria:
Inclusion Criteria:

1. Primary lung tuberculosis who has not previously treated
2. Age more than 19 years and less than 70 years old

Exclusion Criteria:

1. spherical equivalent more than +6.00 diopter or less than -6.00 diopter by autorefraction
2. Closed angel or intraocular pressure more than 21 mmHg
3. Best corrected visual acuity less than 0.5 with severe cataract
4. Retinal disorder include branch retinal vein occlusion, diabetic macular edema, wet-type age-related macular degeneration
5. Age less than 20 years or older than 70 years old
6. Any intraocular surgery less than 3 months
7. Intellectual problems or illiterate whom could not obtained informed consent
Volume Dependent Effect of Pericapsular Nerve Block

In PENG block technique, the local anesthetic agent is injected between the psoas tendon and the pubic ramus to block the sensory branches of the nerves which innervates the hip capsule for providing analgesia without causing muscle weakness. Since the PENG block is a facial plane block, it causes a volume dependent distribution. There are a few case reposts and cadaveric studies on volume dependent effect of analgesia and motor weakness of PENG block.

In our study, we aimed to evaluate the clinical effects of the volume-dependent efficacy of PENG block.

Femur fracture is the one of the most common case groups and it is seen mostly in the elderly patient population with comorbidities. For these patients, perioperative, postoperative analgesia and early mobilization are important to reduce cardiopulmonary complications and morbidity. Femoral fracture operations are mostly performed under spinal anesthesia especially under unilateral spinal anesthesia to sustain more stable hemodynamics. The lateral decubitus position, which is used for unilateral spinal anesthesia, is a painful position for these patients. Intravenous opioids are used for this procedure, however they have possible side-effects, such as sedation, inhibition of respiratory, lower blood pressure. Because of these reasons, pericapsular nerve block (PENG) has been applied recently to avoid complications. By using PENG block , positioning for spinal anesthesia is easier for patients and anesthesiologists, and postoperative analgesia can be provided.

By PENG block, the local anesthetic agent is injected between the psoas tendon and the pubic ramus to block the sensory branches of the nerves innervating the hip capsule, thus providing analgesia in patients, but muscle weakness is not expected. Becacuse PENG block is a facial plane block, it shows a volume dependent distribution. There are a few case reposts and cadaveric studies, which are showing volume depend effect of analgesia and motor weakness of PENG block.

In our study, we aimed to evaluate the clinical effects of the volume-dependent efficacy of PENG block.

Eligibility Criteria:
Inclusion Criteria:

* Patients who will undergoing hip arthroplasty surgery
* Patients over the age of 18
* ASA I-II-III patients
* Patients who will be operated under spinal anesthesia

Exclusion Criteria:

* ASA IV patients, Pregnant women
* Patients who are not suitable for spinal anesthesia
* Patients diagnosed with Alzheimer's and dementia who cannot cooperate
* Patients who are not suitable for peripheral nerve block (patients with infection in the injection area, with local anesthetic allergy, with coagulopathy)
* Patients who do not want to participate in the study
* Patients under the age of 18
* Patients switched to general anesthesia
Ranolazine Loading to Prevent PCI-induced Myocardial Injury

It has previously been shown that pretreatment with ranolazine 1,000 mg twice daily for 7 days can significantly reduce procedural myocardial injury in elective percutaneous coronary intervention (PCI). The investigators tested the hypothesis that twice overnight high-dose ranolazine loading before PCI can reduce the peri-procedural myocardial ischemic damage similarly to long-term pre-treatment with standard doses.

Background

Ranolazine is a novel antianginal drug that reduces intracellular sodium and calcium accumulation during ischemia thus limiting ischemic injury.

It has previously been shown that pretreatment with ranolazine 1,000 mg twice daily for 7 days can significantly reduce procedural myocardial injury in elective percutaneous coronary intervention.

It remains unknown, however, which of these two therapeutic approaches is more effective after PCI.

Purpose

The primary objective of this study is to test the hypothesis that twice overnight high-dose ranolazine loading before PCI can reduce the peri-procedural myocardial ischemic damage similarly to long-term pre-treatment with standard doses.

Eligibility Criteria:
Inclusion Criteria:

* Angiographically-proven coronary artery disease
* Class I indication to elective percutaneous coronary intervention
* Stable conditions
* No recent acute coronary syndromes
* Normal baseline values of markers of myocardial damage (creatine kinase, creatine kinase-MB, myoglobin, and troponin I)
* Able to understand and willing to sign the informed consent form

Exclusion Criteria:

• Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before
Alveolar Ridge Changes With Biologically Oriented Alveolar Ridge Preservation (BARP) After Tooth Extraction

After tooth extraction, the alveolar process undergoes substantial horizontal and vertical resorption specifically in non-molar sites, where horizontal, vertical mid- facial, and mid-lingual ridge reduction could occur . These dimensional changes are clinically relevant, as they may affect dental implant placement and compromise soft tissue aesthetics.

Alveolar ridge preservation (ARP) is based on the application of a bone replacement graft into the extraction socket \& collagen membrane/plug. Recent systematic reviews have shown that ARP may limit bone resorption to about 50% of what is normally observed in case of unassisted healing . This finding indicates that ARP is effective; but at the same time, it underlines the potential for improvement.

In ARP procedures based on socket grafting, the use of a bone replacement graft would prevent up to a 30% of volume reduction in the coronal third. Whereas it has limited effect in the remaining middle-apical thirds . Since grafting of the alveolus often results in the persistence of residual graft particles embedded into the newly formed bone with a delay in the rate of bone deposition and mineralization the need to extend the grafting procedure apical to the coronal third of the socket seems questionable. Based on these considerations, a novel, simplified technique, namely, the Biologically-oriented Alveolar Ridge Preservation (BARP) for ARP that restricts socket grafting to the coronal portion of the socket was presented .

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years old or more.
* Patients with good oral hygiene, defined as a full-mouth plaque score ≤25% (O'Leary et al., 1972).
* Patients who need alveolar ridge preservation after tooth extraction at one or two sites in the aesthetic zone (incisor, cuspid, or premolar area in the maxilla or mandible) with \>50% buccal bone present following tooth extraction (Eeckhout et al., 2022) .
* One or two neighboring teeth.
* Compliant patients who will sign an informed consent and agree to the follow up period.

Exclusion Criteria:

* • Uncontrolled systemic disease

  * Past or current smoking
  * Untreated or unstable periodontitis
  * Untreated caries lesions.
Middle-aged and Older Adults with Hypertension in Rural Communities

Does the m-Health intervention have a positive effect on the health literacy and health promotion behaviors of the study participants?

This study adopted a mixed methods study, and the first stage was a qualitative research design. The second phase was a quantitative research design aims to evaluate the effectiveness of applying healthy lifestyle intervention on the health literacy and health promotion behaviors among middle-aged and older adults with hypertension in rural communities. Recruitment is planned to be conducted in the cardiology outpatient clinic of a regional teaching hospital in the south. It will be a random assignment, single-blind, experimental research design, using simple random sampling to assign to the experimental group and the control group (experimental group: hypertension health education manual + m-Health; control group: hypertension health education manual), a two- month intervention program was carried out, and the questionnaire survey was conducted three times: once as a pre-test and twice as post-tests (during the 4th week and the 8th week of the intervention). Data analysis was conducted using statistical software (SPSS, version 22.0) for data management and statistical analysis, and analysis was conducted using descriptive statistics, independent sample t-test, chi-square test, and generalized estimating equations (GEE).

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with hypertension for one year or more (including) and controlled with medication (systolic blood pressure ≥ 130 mmHg and diastolic blood pressure ≥ 80 mmHg).
2. Aware hypertensive patients aged ≥ 45 years with the ability to read and write.
3. Able to take medication independently.
4. Own a smartphone and are able to use it, and are willing to receive text messages (TxtM) or mobile health interventions (m-Health).
5. Agree to participate in the study.

Exclusion Criteria:

1. Have cognitive impairments or mental disorders.
2. CCI (Charlson Comorbidity Index) score ≥ 3.
Proclear 1-D Multifocal Nondispensing Study

This study is designed to compare the relative performance related to subjective and objective vision between two multifocal soft contact lenses.

The aim of this study was to compare the subjective and objective vision. of Proclear® 1-D Multifocal test lenses (MF) with +0.75D overcorrection of the distance lens power in the nondominant eye compared to the Air Optix® Aqua Multifocal (CIBA VISION) contact lenses in low, Medium and High Add presbyopic subjects (+1.25 to +2.50 inclusive).

Eligibility Criteria:
Inclusion Criteria:

* Be between 40 and 65 years of age (inclusive)
* Require a reading addition of +1.25 to +2.50D (inclusive)
* Spherical distance CL or spectacle prescription between +3.00D and -5.00D(inclusive)
* Spectacle cylinder less than or equal to 0.75D in both eyes.
* Currently has a reading add correction in their spectacle or CL habitual correction (e.g. if myope, removes distance correction to read)
* Normal binocularity (no amblyopia, no strabismus, no habitually uncorrected anisometropia ≥ 2.00D)
* Have a minimum 2 weeks soft contact lens experience
* Be able to wear the study lens (e.g. good fit is attained and acceptable subjective comfort and vision for the duration of the study)
* Able to read, comprehend and sign an informed consent
* Willing to comply with the wear and study visit schedule
* Monocular best-corrected distance visual acuity ≥ 20/25 in each eye
* No gas permeable contact lens wear for 1 month prior to the study

Exclusion Criteria:

To be eligible for the study, each candidate must not present with any of the following

* Any active corneal infection, injury, inflammation, or ocular abnormality
* Systemic or ocular allergies, which might interfere with contact lens wear
* Systemic disease, which might interfere with contact lens wear
* Ocular disease, which might interfere with contact lens wear
* Pregnant or lactating
* Strabismus/amblyopia
* Habitually uncorrected anisometropia greater than or equal to 2.00 D
* Subjects who have undergone corneal refractive surgery
* Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
Diagnosis and Follow-up of Patients With Subclinical Hypothyroidism

Long term follow-up of the patients with delayed TSH elevation or subclinical hypothyroidism has been seldom reported. The purpose of this study was to explore the diagnostic criteria for subclinical hypothyroidism and the initial dosage of L-thyroxine through long-term follow up for infants with subclinical hypothyroidism ，and evaluate the curative effect.

Long term follow-up of the patients with delayed TSH elevation or subclinical hypothyroidism has been seldom reported. The purpose of this study was to explore the diagnostic criteria for subclinical hypothyroidism and the initial dosage of L-thyroxine through long-term follow up for infants with hyperthyrotropinemia，and evaluate the curative effect.All live-born neonates in province took part in the screening program from October, 1999 to September ,2006. Laboratory tests are performed as a time resolved fluoro-immunoassay (TRFIA). TSH is measured with a cut-off \> 9 mU/L. The diagnostic standard for subclinical hypothyroidism was: TSH ≥ 20 mU/L, T3 and T4 normal or low-normal ,or TSH \> 5.6 mU/L and \< 20 mU/L on initial determination and on follow-up or TSH levels increase on follow-up and/or gradually declining T4 levels.L-Thyroxine was administered for substitution therapy. After 2 years therapy，allround evaluation was performed. Compare the correlation to effects with different level of TSH、starting time of therapy and environment. Compare the effects between subclinical、temporary and permanent hypothyroidism.

Eligibility Criteria:
Inclusion Criteria:

* The diagnostic standard for manifest hypothyroidism and subclinical hypothyroidism was defined as follows:

  * Hypothyroidism - TSH \> 40 mU/L and T3 and T4 below the reference range or TSH \> 40 mU/L, T3 normal and T4 below the reference range \[2\]
  * Subclinical hypothyroidism - TSH ≥ 20 mU/L, T3 and T4 normal or low-normal or TSH \> 5.6 mU/L and \< 20 mU/L on initial determination and on follow-up or TSH levels increase on follow-up and/or gradually declining T4 levels.