bioihbjkbjnl/mcl2 huggingface dataset:
Osteocalcin Level in Gingival Clavicular Fluid During Canine Retraction in Periodontal Compromised Patients
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases
Study type: Interventional

Summary: 
      Osteocalcin levels can be measured Gingival crevicular fluid (GCF). Changes in osteocalcin
      levels can provide important information about the status of bone metabolism and bone
      remodeling. The levels of this markers in GCF can provide information about the status of
      bone remodeling in the surrounding bone tissue in periodontal affected teeth.
    

Detailed description: 
      Osteocalcin levels can be measured using a blood test or by analyzing the levels of
      osteocalcin in urine or saliva. Changes in osteocalcin levels can provide important
      information about the status of bone metabolism and bone remodeling. Osteocalcin has been
      found to be present in Gingival crevicular fluid (GCF), along with other bone metabolism
      markers such as alkaline phosphatase and tartrate-resistant acid phosphatase. The levels of
      these markers in GCF can provide information about the status of bone remodeling in the
      surrounding bone tissue. Orthodontic tooth movement is influenced by the remodelling ability
      of surrounding bone and soft tissue, such as PDL and gingiva. Bone remodelling occurs in
      coordination, requiring coupling of bone formation after resorption. Orthodontic force
      induces an aseptic inflammatory response, involving cytokines and chemokines. . Increased
      levels of osteocalcin in body fluids indicate abnormal bone turnover activity.
    

Intervention name(s): measure Osteocalcin level
Intervention type(s): Diagnostic Test
Intervention description(s): in gingival crevicular fluid before and during orthodontic tooth movement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: osteocalsin; periodontal compromised teeth; canine retraction
Study of ESBA105 Eye Drops in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Objectives:

      To evaluate the safety, tolerability and pharmacokinetics of ESBA105 administered topically
      to the eye for up to 28 days in healthy volunteers.

      To determine the systemic exposure to ESBA105 upon single and repeated-dose topical
      application to the eye in healthy volunteers.
    

Detailed description: 
      ESBA105 is an anti TNF single chain antibody fragment
    

Intervention name(s): ESBA105
Intervention type(s): Drug
Intervention description(s): eye drops
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: opthalmology; antibody fragment; TNF alpha
Body Mass Index, Academic Stress and Musculoskeletal Disorders Relationships
Condition: BMI, Academic Stress and MSDs Relationships
MeSH terms: Musculoskeletal Diseases
Study type: Observational

Summary: 
      [Purpose] To investigate the prevalence of musculoskeletal disorders among healthy students
      of Ahlia University and to determine the relationship between the prevalence of
      musculoskeletal disorders and academic stressors and body mass index. [Subjects and Methods]:
      Self-administered questionnaires were distributed to 94 students aged 18-26 years who were
      enrolled at various Ahlia University colleges and met other inclusion criteria. The students
      responded to the standardized Nordic musculoskeletal questionnaire and the modified College
      Student Stress Inventory regarding musculoskeletal symptoms and academic stressors. Height
      and weight measurements were also obtained to determine body mass index.

      Keywords: Body mass index, Academic stress, Musculoskeletal disorders
    

Detailed description: 
      [Purpose] To investigate the prevalence of musculoskeletal disorders among healthy students
      of Ahlia University and to determine the relationship between the prevalence of
      musculoskeletal disorders and academic stressors and body mass index. [Subjects and Methods]:
      Self-administered questionnaires were distributed to 94 students aged 18-26 years who were
      enrolled at various Ahlia University colleges and met other inclusion criteria. The students
      responded to the standardized Nordic musculoskeletal questionnaire and the modified College
      Student Stress Inventory regarding musculoskeletal symptoms and academic stressors. Height
      and weight measurements were also obtained to determine body mass index.

      Keywords: Body mass index, Academic stress, Musculoskeletal disorders
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A total of 28 male and 66 female students (age, 18-26 years; mean, 21 ± 1.9 years) from
        various Ahlia University colleges were recruited to participate in this study.
      
Keywords: Body mass index; Academic stress; Musculoskeletal disorders
Food Effect Study of VER-01 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluation of pharmacokinetics, tolerability and safety of VER-01 depending on the intake a
      high-fat meal in healthy volunteers
    

Detailed description: 
      Determination of the effect of food intake on the pharmacokinetic (PK) profile of VER-01 in
      healthy volunteers.

      Group 1: 9 subjects receive VER-01 (corresponding to 10 mg THC) in the morning after a
      10-hour fasting period on day 1, and 30 minutes after the intake of a standardised high-fat
      breakfast has been started on day 4.

      Group 2: 9 subjects receive VER-01 (corresponding to 10 mg THC) in the morning after 30
      minutes after the intake of a standardised high-fat breakfast has been started on day 1 and
      after a 10-hour fasting period on day 4.
    

Intervention name(s): VER-01
Intervention type(s): Drug
Intervention description(s): standardised cannabis extract (containing 21 mg THC per gram drug product)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: THC; Tetrahydrocannabinol; Cannabis; Pharmacokinetics
Establishment of the Breast Milk Database in China
Condition: Breast Milk Collection
Study type: Observational

Summary: 
      Collect breast milk samples in various administrative regions of China to measure the
      nutrients in breast milk; analyze the composition of nutrients; and establish the database of
      breast milk in China.
    

Detailed description: 
      The study cities are Guangzhou, Weihai, Chengdu, Beijing, Harbin, Wuhan, Jinhua, Zhengzhou
      and Lanzhou.

      Breast milk will be collected at 9:00-11:00 in the morning from 15 to180 days after giving
      birth. The nutrients (protein, triglyceride, phospholipid, oligosaccharides and probiotics)
      in the collected breast milk samples will be measured. These data will be used to establish
      the breast milk database in China. This databased will provide references for infant nutrient
      intake and for the formulation and revision of infant formula standards. It will also provide
      references for the development of new infant formula products in China.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Healthy lactating mother of 25 ~ 35 years old who are currently breast-feeding infants of
        15 ~180 days old. Subjects are equally distributed in the postpartum time period of 15~35
        days, 36~65 days, 66~95 days, 96~125 days, 126~55 days and 156~185 days
      
Biospecimen description: 
      A minimum of 60ml of breast milk will be collected for each subject.
The Study of CCTM and Common Diseases
Condition: Hypertension; Diabetes Mellitus; Chronic Obstructive Pulmonary Disease Moderate; Coronary Artery Disease; Obesity
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Coronary Artery Disease
Study type: Observational

Summary: 
      This study aimed to explore the associations between constitutions of traditional Chinese
      medicine (TCM) and common disease (CD). A large-scale, community-based, cross-sectional study
      was performed to investigate the associations. A total of 3748 participants were available
      for analysis in this study. The assessment of constitution of TCM was based on
      recommendations of Association Chinese Medicine in China. In this study, the diagnosis of CD
      was based on self-reported medical history. The associations were analyzed using univariate
      and multivariable logistic regression (MLR).
    

Detailed description: 
      This study aimed to explore the associations between constitutions of traditional Chinese
      medicine (TCM) and common disease (CD). A large-scale, community-based, cross-sectional study
      was performed to investigate the associations. A total of 3748 participants were available
      for analysis in this study. The assessment of constitution of TCM was based on
      recommendations of Association Chinese Medicine in China. In this study, the diagnosis of CD
      was based on self-reported medical history. The associations were analyzed using univariate
      and multivariable logistic regression (MLR).
    

Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        A risk-factor study for constitution of TCM and chronic disease was conducted in a random
        sample of the Chinese population. Participants aged 30-90 years were recruited from rural
        and urban communities in Shanghai. More than 4,000 participants were invited to a screening
        visit between 2011 and 2013. Written consent was obtained from all patients before the
        study, which was performed in accordance with the ethical standards in the Declaration of
        Helsinki, and approved by the Medicine Ethical Committee of the Huashan Hospital. The
        exclusion criteria were 1) severity renal and liver function abnormal and 2) pregnant
        woman. A total of 3748 participants were available to data analysis.
NOWOX Oxygen Therapy Monitoring Device
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the duration of oxygen use recorded by the NOWOX,
      under usual conditions of daily living, in patients with chronic obstructive respiratory
      disease requiring oxygen therapy.
    

Detailed description: 
      Long Term Oxygen Therapy (LTOT) is one of the main non pharmacologic treatments for patients
      with severe lung disease. This continuous or sub-continuous oxygen supplementation is
      generally introduced at home in patients who have chronic cardio respiratory failure and
      severe resting hypoxemia to maintain sufficient blood oxygenation and therefore preserve
      vital organ function.

      LTOT effectiveness has mainly been evaluated and documented in patients with COPD, which also
      accounts for most of its prescriptions. In these patients, LTOT has been shown to have a
      beneficial impact on haemodynamics, exercise capacity, lung mechanics and mental state. Its
      implementation was furthermore associated with reduced yearly hospitalisation days and
      increased survival Measuring adherence is an extremely important and under-evaluated
      component of oxygen therapy. NOWOX, medical device has been designed,developed and
      manufactured to measure adherence to LTOT and additionally to measure patient's respiration
      rate
    

Intervention name(s): NOWOX
Intervention type(s): Device
Intervention description(s): one experimental device assigned to each of the 10 patients including in the study for an experiemental session duration of 6 hours
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: to verify accurrancy of data collected by the NOWOX
Immune-modulatory Effect of Probiotic Strain on Grass Pollen Allergic Individuals
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional

Summary: 
      The purpose of the current study is to evaluate the effect of administering a probiotic
      strain on allergic symptoms and immune parameters (Th-2 cytokines, effector cells) in
      seasonal allergic rhinitis subjects.
    

Detailed description: 
      To identify immune markers in allergic individuals that are impacted by probiotic treatment
      during seasonal exposure
    

Intervention name(s): Maltodextrin; Probiotic
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): maltodextrin powder; probiotic blended in maltodextrin powder
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Influence of Combined Double-Bundle ACL Reconstruction With Lateral Retinacular Release to Prevent Patellofemoral Malalignment in Isolated ACL Rupture
Condition: ACL Injury
MeSH terms: Rupture; Anterior Cruciate Ligament Injuries
Study type: Interventional

Summary: 
      Anterior knee pain which might be due to patellofemoral malalignment is an inevitable post
      operative complication after an ACL reconstruction (ACLR). We combined the double bundle ACLR
      technique with lateral release technique to prevent patellofemoral malalignment post ACLR.
    


Intervention name(s): ACL reconstruction
Intervention type(s): Procedure
Intervention description(s): performed arthroscopically
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy of AS-3201 in the Treatment of Diabetic Sensorimotor Polyneuropathy
Condition: Diabetic Neuropathy
MeSH terms: Diabetic Neuropathies; Polyneuropathies
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a safety and efficacy trial of ranirestat(AS-3201) which is an aldose reductase
      inhibitor in patients with diabetic sensorimotor polyneuropathy.
    


Intervention name(s): ranirestat, (AS-3201)
Intervention type(s): Drug
Intervention MeSH terms: Ranirestat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Diabetic sensorimotor polyneuropathy; Diabetic Neuropathy
IA or PE - What is the Best Treatment Option of Steroid Refractory Neurological Autoimmune Diseases
Condition: Neurological Autoimmune Diseases
MeSH terms: Autoimmune Diseases
Study type: Interventional

Summary: 
      In this prospective controlled monocentric observational study, we assessed safety and
      efficacy of therapy with IA or PE in patients with neurological autoimmune diseases. In the
      subgroup analysis of MS patients also the EDSS was evaluated. In addition, we investigated
      possible pathomechanisms, such as cytokine alterations under therapy.
    

Detailed description: 
      Plasma exchange (PE) and immunoadsorption (IA) are first- or second line treatment options in
      patients with neurological autoimmune disease, including multiple sclerosis, neuromyelitis
      optica, chronic inflammatory demyelinating polyneuropathy, acute inflammatory demyelinating
      polyradiculoneuropathy (Guillain-Barré-Syndrom) or autoimmune encephalitis. This prospective
      controlled monocentric observational study of patients treated with either tryptophan IA or
      PE in cases of autoimmune neurological therapy refractory disease was performed between 2016
      and 2019. The main outcome parameter for efficiency was clinical improvement after completion
      of treatment with PE/IA. Symptoms were assessed before the first and after the last IA/PE. In
      total, all patients receive 5 treatments. As patients with various neurological autoimmune
      diseases were included in the study, the overall treatment response was categorized
      descriptively as improvement or no improvement of symptoms.
    

Intervention name(s): Apheresis therapy by Octo Nova Technology (DIAMED, Cologne, Germany)
Intervention type(s): Other
Intervention description(s): One group was treated with IA and the single use tryptophan adsorber, the other group was treated with PE and the Plasmaflow (see above). In total, all patients receive 5 treatments.
Other intervention name(s): IA treatment: using single-use tryptophane adsorber TR 350 in combination with the OP-0,5W plasma separator (Asahi Kasei Medical, Tokyo, Japan) and the tubing system PA-420; PE treatment: using Plasmaflow OP 0,5W (L) and the tubing system AV-120 and FS-250
Intervention MeSH terms: Tryptophan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective controlled monocentric observational study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Plasma exchange (PE); immunoadsorption (IA); multiple sclerosis; neuromyelitis optica,; chronic inflammatory demyelinating polyneuropathy; acute inflammatory demyelinating polyradiculoneuropathy; autoimmune encephalitis
Total Laparoscopic Versus Open Aortic Surgery for Abdominal Aortic Disease
Condition: Graft Occlusion, Vascular
MeSH terms: Aortic Diseases; Graft Occlusion, Vascular
Study type: Observational [Patient Registry]

Summary: 
      This prospective study was designed to analyse the postoperative and long-term outcomes of
      total laparoscopic vs. open surgical repair of infra-renal abdominal aortic occlusive disease
      (AOD) and infra-renal aortic aneurysmal disease (AAA) in comparable groups of patients using
      a propensity analysis model.
    

Detailed description: 
      From January 2006 to January 2010, 228 consecutive patients who received an aortic bypass for
      AAA (n=139) or for AOD (n=89) were studied. Open repair was performed in145 patients
      (AAA=109, AOD=36) and total laparoscopic repair in 83 patients (AAA=30, AOD=53). One-to-one
      propensity score matching between study groups was done according to a difference in the
      logit of propensity score of less than 0.04 between each patient pairs in the study groups.
      Logistic regression with the help of backward selection was used to adjust the effect of
      treatment method for propensity score as well as other variables in evaluating postoperative
      and long-term outcome. A p value < .05 was considered statistically significant.
    

Intervention name(s): Aortic repair
Intervention type(s): Procedure
Intervention description(s): Aortic bypass
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All consecutive patients presenting with an abdominal aortic aneurysm or an occlusive
        aortic disease operated from January 2006 to January 2010.

        Open repair was performed in145 patients (AAA=109, AOD=36) Total laparoscopic repair was
        performed in 83 patients (AAA=30, AOD=53).
Study of Obeldesivir in Nonhospitalized Participants With COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of this clinical study is to test if obeldesivir (formerly GS-5245) is safe and
      effective for the treatment of coronavirus disease 2019 (COVID-19) in participants who have a
      standard risk of developing severe illness. This study will also measure how much obeldesivir
      gets into the blood and how long it takes for the body to get rid of it.
    


Intervention name(s): Obeldesivir; Obeldesivir Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablet administered orally without regard to food.; Tablet administered orally without regard to food.
Other intervention name(s): GS-5245
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Prognostic Perspective of Invasive Hyperemic and Non-Hyperemic Physiologic Indices Measured After Percutaneous Coronary Intervention
Condition: Ischemic Heart Disease
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease
Study type: Observational

Summary: 
      Coronary physiologic assessments by the pressure-derived fractional flow reserve (FFR) have
      become standard methods for identifying hemodynamic deprivation in coronary arterial stenosis
      for evidence-based percutaneous coronary intervention (PCI). Invasive physiologic
      indices-guidance enables on-site real time assessment for functional significance of
      epicardial coronary stenosis and the use of those indices has shown to be effective to guide
      treatment decision. Several studies further support the role of post-PCI FFR measurement as a
      functional marker of residual disease after PCI and prognostic indicator of patients.
      Although optimal cut-off values of post-PCI FFR varied across studies, an inverse
      relationship between post-PCI FFR and the risk of future clinical events have been reported
      consistently.

      Recently, non-hyperemic pressure ratios (NHPRs) have been introduced in clinical practice.
      Although there are several different NHPRs, previous studies consistently indicated that
      those NHPRs shares similar diagnostic performance and prognostic implications. Nevertheless,
      few reports were available for clinical relevance of NHPRs in evaluation of post-PCI status.

      In this context, we will evaluate the physiologic characteristics and prognostic implication
      of post-PCI NHPRs and compare with those of post-PCI FFR in patients who underwent
      angiographically successful PCI with 2nd generation drug-eluting stent implantation (DES).
    

Detailed description: 
      Patients who diagnosed significant coronary artery disease and treated by 2nd generation DES
      with post-PCI physiologic evaluation would be enrolled.

      Invasive physiologic assessment including recording of resting pressure trecing would be
      required at the baseline and at the end of index PCI procedure. PCI procedure would be
      performed upon local routine. Any available 2nd generation DES could be used. Web-based
      electronic-case record form (CRF) system will be used for collecting data. All data will be
      handled and analyzed by blind fashion at independent core lab. 2-year clinical outcome after
      index procedure will be analyzed.
    

Intervention name(s): Percutaneous coronary intervention
Intervention type(s): Device
Intervention description(s): PCI was performed using 2nd generation DES
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who diagnosed obstructive coronary artery disease and treated by DES with invasive
        physiologic evaluation at the index procedure
      
Keywords: fractional flow reserve; non-hyperemic pressure ratio; percutaneous coronary intervention; prognosis; myocardial ischemia