bioihbjkbjnl/mcl2 huggingface dataset:
A Multicenter Prospective Study of Application of Platelet Mapping in Acute-on-chronic-liver Failure in China
Condition: Thrombelastography; Acute on Chronic Liver Failure; Platelet; Multicenter Prospective Study
MeSH terms: Liver Failure; Hepatic Insufficiency; End Stage Liver Disease; Acute-On-Chronic Liver Failure
Study type: Observational

Summary: 
      Ineffective hemostasis or a paradoxical prothrombotic state of Acute-on-chronic liver disease
      (ACLF) has been well established. Thrombelastography measures the dynamics of thrombin
      production and provides a global assessment of coagulation incorporating the cumulative
      effect of the interactions at various levels between plasma components and cellular component
      of coagulation. And through the platelet mapping, it can help provide a picture of patients'
      function of platelet. Based on the primary result of our derivation cohort(NCT03281278), ACLF
      patients with high ADP inhibition rate had high 28-day mortality.This multicenter validation
      cohort aims to validate the predictive role of platelet mapping in ACLF prognosis, organ
      failure developments and short term mortality.
    


Intervention name(s): standard treatment
Intervention type(s): Other
Intervention description(s): standard medical treatment
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with ACLF regardless of aetiology, International Normalized Ratio (INR)≥1.5 and
        total bilirubin≥85μmol/L
      
Keywords: Thrombelastography; Acute on Chronic Liver Failure; Platelet; Multicenter Prospective Study
Safety, Tolerability and Pharmacokinetics of ALD1910 in Healthy Men and Woman
Condition: Migraine
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability and pharmacokinetics of
      ALD1910, a monoclonal antibody, administered by intravenous infusion and subcutaneous
      injection.
    

Detailed description: 
      This is a first-in-humam, randomized, double-blind, placebo-controlled study in a healthy
      population. Up to 7 single ascending doses (cohorts 1 to 7) will be studied to determine the
      safety and tolerability of ALD1910. Approximately 96 healthy male and female participants are
      planned for the study, 64 for Part A and 32 for Part B.
    

Intervention name(s): ALD1910; Sumatriptan; ALD1910
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Single Dose IV infusion; Single dose subcutaneous injection; Single dose subcutaneous injection
Intervention MeSH terms: Sumatriptan
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Smoking and Non-surgical Periodontal Treatment on Gingival Crevicular Fluid Cyclophilin A and EMMPRIN Levels
Condition: Smoking; Periodontitis; Non-surgical Periodontal Treatment
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      This study aimed to investigate the effect of smoking and non-surgical periodontal treatment
      on gingival crevicular fluid CyPA and EMMPRIN levels in patients with periodontitis.
      Twenty-eight patients with periodontitis (14 non-smoker and 14 smoker) and 30 control
      subjects (15 non-smoker and 15 smoker) were included into the study. Non-surgical periodontal
      treatment was applied to all periodontitis patients. Periodontal parameters and GCF CyPA and
      EMMPRIN levels were evaluated during 3 months following non-surgical periodontal treatment.
      GCF CyPA and EMMPRIN levels were analyzed by ELISA.
    


Intervention name(s): non-surgical periodontal treatment
Intervention type(s): Procedure
Intervention description(s): Non-surgical periodontal treatment program was as following: First, motivation and oral hygiene instructions were given to all participants with periodontitis. The modified-Bass tooth brushing technique with a given dentifrice and toothbrush twice a day, and dental flossing/ interdental brushing once a day was advised to all patients with periodontitis. Second, scaling using an ultrasonic device and root planning by hand instruments under local anesthesia was performed.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Dose Escalation Study of Intravenous L-citrulline in Steady-state Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the maximum tolerated dose, safety and
      pharmacokinetics of an investigational drug, intravenous (IV) citrulline, in subjects in
      steady-state sickle cell disease.
    


Intervention name(s): Intravenous (IV) citrulline
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Adipocyte Function and Somtropin Deficiency
Condition: Growth Hormone Deficiency
Study type: Observational

Summary: 
      To assess the influence of exogenous GH (growth hormone) administration on adipocyte
      endocrine function (leptin, adiponectin, and resistin) and on ghrelin secretion in children
      with delayed growth due to GH deficiency.

      Study hypothesis: hormones produced by the adipocyte (leptin, adiponectin, and resistin) and
      ghrelin may exert a certain control on production of GH and IGF-I, and GH may in turn have a
      regulatory effect on such hormones.
    


Intervention name(s): Growth Hormone
Intervention type(s): Drug
Intervention MeSH terms: Hormones
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with GH deficiency
Non Surgical Peri-implant Mucositis Treatment in Patients With Tissue-level and Bone-level Implants
Condition: Peri-implant Mucositis
MeSH terms: Mucositis
Study type: Interventional

Summary: 
      This study is designed to compare the resolution of inflammation of naturally-occurring
      peri-implant mucositis (PM) at tissue-level (TL) and bone-level (BL) implants after
      non-surgical mechanical debridement.
    

Detailed description: 
      Group A: Peri-implant mucositis (PM) at tissue-level (TL) implants after non-surgical
      mechanical debridement.

      Group B: Peri-implant mucositis (PM) bone-level (BL) implants after non-surgical mechanical
      debridement.
    

Intervention name(s): Bleeding on Probing change reduction following peri-implant mucositis non surgical therapy
Intervention type(s): Other
Intervention description(s): Statistically significant different in terms of Bleeding on Probing will be recorded between groups.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Compare resolution of inflammation of naturally-occurring peri-implant mucositis (PM) at tissue-level (TL) and bone-level (BL) implants after non-surgical mechanical debridement.
Masking: Single (Participant)
Primary purpose: Supportive Care
Metformin and Oral Contraceptives in PCOS
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Background: PCOS is a common condition with a prevalence of 5-8 % in premenopausal women.
      More than 50% of PCOS patients are insulin resistant and have a diabetes risk 5-8 times
      higher than age- and weight-matched controls. Studies using insulin sensitizers in PCOS found
      increased insulin sensitivity and decreased insulin levels to be followed by decreased
      androgen levels and improved ovulatory function. No studies however, evaluated the long term
      effects of insulin sensitizing treatment.

      Oral contraceptives normalize menstrual cycles and suppress androgen levels in PCOS, however
      no long-term studies evaluated the effects of combined treatment with metformin and oral
      contraceptives in PCOS.

      Design: Randomized open study in 3*30 PCOS patients. Patients are randomised to 24 months of
      treatment with 1: metformin, 2: metformin and oral contraceptives or 3: oral contraceptives.

      Primary outcome measures: fasting insulin, AUC insulin. Secundary endpoints: BMI, WHR, LH,
      FSH, total and free-testosterone, c-peptid, urinary cortisol, AUC for insulin, glucose and
      c-peptid during OGTT.

      Inclusioncriteria:

        1. Irregular menses or anovulaty cycles

        2. High free testosterone > 0,035 nmol/l or hirsutism

        3. PCO in vaginal US Criteria 1 and 2 OR 2 and 3.

      Design:
    

Detailed description: 
      90 patients are included and randomized to 12 months of treatment with metformin (1000+1000
      mg/d) or OCP (150 mg desogestrel 30 microgram ethinylestradiol) or combined treatment
      (metformin+OCP).

      Patients attend a biochemical and physical examination at study inclusion and at 12 months.
      Patients attend for registration of side effects and compliance after 6 months of study
      duration. Safety tests are performed at all three visits and include weight, blood pressure,
      HbA1c, liver enzymes, electrolytes, and white blood cell count. Pregnancy tests are performed
      by the participants each month. Patients are given general advice on lifestyle intervention.
      Patients are excluded if they initiated medical treatment with possible hormonal and
      metabolic effects during the intervention period. Lifestyle intervention is allowed. Laser
      treatment is offered to patients with moderate or severe facial hirsutism and patients are
      allowed to shave/wax. The patients accept not applying cosmetic treatment 3-4 days before
      attending for evaluation at the clinic.
    

Intervention name(s): Metformin; Desorelle
Intervention type(s): Drug; Drug
Intervention description(s): 500 mg 2 tablets 2 times a day; 1 tablet/day in 21 days
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Polycystic ovary syndrome
Understand the Difference Between Clinical Measured UF and Real UF.
Condition: Peritoneal Dialysis
Study type: Observational

Summary: 
      The importance of ultrafiltration (UF) and fluid status in peritoneal dialysis has been
      increasingly aware of over the last two decades. There is growing body of observational
      evidence showing that low UF is related to unfavorable outcome especially in anuric patients.
      The other side of the problem of UF is excessive fluid removal could volume deplete patients
      and result in loss of residual renal function and overexposing the membrane to glucose
      unnecessarily. UF is a double-edged sword. The correct measure of UF is the bottom line of
      talking about target.

      Measuring UF is supposed to be simple and straight forward. The most common way of measuring
      UF in clinical practice was to weight the effluent bag and minus the manufacture announced
      fill volume.

      Until about 10 years ago, the society first aware that the measurement error in such way is
      not acceptable. Overfil (the actual volume of dialysate fill in the bag is more than
      announced) problem was raised from then.

      However, there are several other problems around this issue. Firstly, when the product has
      just been produced overfill is different between manufactory.

      Secondly, the overfill volume does change over transportation and storage. But it is not
      clear how big the change is.

      Thirdly, most of the clinics weight the dialysate effluent rather than measure the volume in
      CAPD, although the specific gravity of dialysate is clearly not going to be 1g/ml.

      Taking the fact measuring weight is much easier than measuring volume in CAPD, the question
      behind is to understand how big the difference is and consequently whether it is acceptable.

      All the patients enrolled in the study would be asked to collect all dialysate effluent of
      the day of their routine peritoneal dialysis adequacy study and bring to the hospital. The
      exact weight of the bag for PET test (2.5% glucose concentration and dwell time of 4 hour)
      before and after the dwell and volume measured of the effluent. The dialysate electrolyte,
      glucose, protein and creatinine level would also be measured.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adult (>18years), both gender, end stage renal disease on PD treatment
Effect of Activity Modification and Exercises in Young Adolescents With Osgood Schlatter Disease.
Condition: Osgood Schlatter Disease
MeSH terms: Osteochondrosis
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of activity modification, exercises
      and a gradual return to sport in adolescents (age 10-14) with Osgood Schlatter disease. The
      primary outcome is self-reported recovery on a 7-point Likert scale at 3 months. Secondary
      endpoints include 4 and 8 weeks and 6 and 12 months after inclusion into the project. The
      adolescents will be recruited from primary schools, general practitioners and through online
      advertising on Facebook.
    


Intervention name(s): Activity modification, exercises and gradual return to sport
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ultrasound-guide Corrected Glenohumeral Internal Rotation Deficit
Condition: Glenohumeral Internal Rotation Deficit
MeSH terms: Shoulder Injuries
Study type: Observational

Summary: 
      Background:

      Glenohumeral internal rotation deficit (GIRD) is believed to be one of the risk factors
      contributing to shoulder injuries. In addition, athletes with GIRD of greater than 20° appear
      to be at a greater risk for the shoulder injuries and surgery. Recently, GIRD can be divided
      in anatomical GIRD and pathological GIRD (pGIRD). The dominant arm of the athletes with pGIRD
      have not only humeral retrotorsion (HR) but also stiffer posterior capsule. The soft-tissue
      effect is believed to be the key point in pathological cascade of throwers. Therefore, the
      previous studies use gross GIRD as a risk factor may be modified by ultrasound-guide
      corrected GIRD.

      Objective:

      There are 4 objectives for the present study: (1) to investigate the Receiver operating
      characteristic (ROC) curves of the gross GIRD; (2) to investigate the ROC curves of the
      ultrasound-guide corrected GIRD; (3) to compare the area under curve (AUC) of the two
      methods; (4) to compare the gross GIRD and the ultrasound-guide corrected GIRD in baseball
      players.

      Design:

      Baseball players who have played baseball for at least 1 year and still active in training or
      competition will be recruited in this study. Participant characteristics will be collected by
      the main assessor, including age, gender, height, weight, dominant arm, practice time, years
      of playing baseball. Performance/function will be assessed via a Kerlan-Jobe Orthopaedic
      Clinic shoulder and elbow (KJOC) self-report questionnaire. The shoulder rotation ROM,
      ultrasound examination including ultrasound-corrected GIRD and posterior capsular thickness
      and posterior shoulder tightness will also be measured. we will follow subjects for a season.
      Once the injury occurs, deterioration or at the end of the season, we will collect the data
      again.

      Main outcome measures:

      The shoulder rotation ROM, ultrasound examination and posterior shoulder tightness are main
      outcomes of the study.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A baseball team usually consists of 30 to 40 players. Therefore, we will recruit 3 or 4
        local baseball teams in Taipei and New Taipei city. Based on the consideration of schedule
        between baseball teams and our research team, We will collect 7 subjects per day and the
        recruitment time will last for about a month.
      
Keywords: shoulder injury,ultrasound
Counteracting Learned Non-use Through Augmented Visuomotor Feedback in Virtual Reality (RGS)
Condition: Hemiparesis
MeSH terms: Paresis
Study type: Interventional

Summary: 
      The purpose of this study is to determine if Reinforcement-Induced Movement Therapy (RIMT), a
      novel rehabilitation method that augments visuomotor feedback of movements of the patient in
      virtual reality, is effective in treating hemiparesis resp. learned non-use.
    


Intervention name(s): Reinforcement-Induced Movement Therapy (RIMT); VR-based motor rehabilitation in RGS without augmented feedback
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 6 weeks, 1 session a day, 30min per sessions, of physical therapy using a VR rehabilitation gaming system (RGS) with augmented visuomotor feedback; 6 weeks, 1 session a day, 30min per sessions, of physical therapy using a VR rehabilitation gaming system (RGS)
Other intervention name(s): VR-based motor rehabilitation in RGS with amplified visuomotor feedback
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; learned non-use; Virtual Reality; Hemiparesis
An Investigational Study of Experimental Medication BMS-986231 Given in Participants With Different Levels of Liver Function
Condition: Liver Dysfunction; Liver Insufficiency; Hepatic Failure; Myocardial Failure; Cardiac Failure; Congestive Heart Failure; Heart Decompensation
MeSH terms: Liver Diseases; Liver Failure; Hepatic Insufficiency; Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an investigational study of experimental Medication BMS-986231 given to participants
      with weakened or damaged liver function.
    


Intervention name(s): BMS-986231
Intervention type(s): Drug
Intervention description(s): Intravenous (IV) administration
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Investigate the Clinical and Parasiticidal Activity and Pharmacokinetics of Different Doses of Artefenomel and Ferroquine in Patients With Uncomplicated Plasmodium Falciparum Malaria
Condition: Plasmodium Falciparum Infection
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

      To show the contribution of artefenomel (OZ439) to the clinical and parasiticidal effect of
      OZ439/Ferroquine (FQ) combination by analyzing exposure-response of OZ439 measured by Day 28
      polymerase chain reaction (PCR)-corrected adequate clinical and parasitological response
      (ACPR) for the effect and the area under the curve (AUC) of OZ439 as pharmacokinetic (PK)
      predictor.

      Secondary Objectives:

        -  To evaluate the exposure-response of OZ439 combined with FQ on crude Day 28 ACPR.

        -  To evaluate the dose response of OZ439 combined with FQ on PCR-corrected and crude Day
           28 ACPR.

        -  To evaluate the dose-response of OZ439 combined with FQ on selected secondary endpoints.

        -  To evaluate the safety and tolerability of different dosages of OZ439 in combination
           with FQ and FQ alone.

        -  To characterize the PK of OZ439 in plasma, and of FQ and its active metabolite SSR97213
           in blood.
    

Detailed description: 
      The duration of the study was up to 32 days, including up to 1 day screening period before
      the single-dose treatment, 5 days of post-treatment surveillance (included 2 to 4 days
      hospitalization) and 24±2 days follow-up period.
    

Intervention name(s): Artefenomel (OZ439); Ferroquine (SSR97193)
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: Granules for oral suspension Route of administration: Oral; Pharmaceutical form: Capsule Route of administration: Oral
Intervention MeSH terms: Artefenomel; Ferroquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety of Somatropin and Induction of Puberty With 17-beta-oestradiol in Girls With Turner Syndrome
Condition: Genetic Disorder; Turner Syndrome
MeSH terms: Turner Syndrome; Gonadal Dysgenesis; Genetic Diseases, Inborn; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is conducted in Europe. The aim of this trial is to assess whether increasing
      doses of somatropin (Norditropin®) can maintain the initial increase in height velocity and
      improve final height. This trial has two trial periods, a main period of 4 years and an
      extension period until final height is reached.
    


Intervention name(s): somatropin; somatropin; somatropin; oestrogen
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 4 IU/m^2 body surface for 4 years (main period). In extension period subjects continue the reached dose until final height. Administered as once daily subcutaneous injection; Initial dose 4 IU/m^2 body surface the first year, then 6 IU/m^2 body surface for 3 years (main period). In extension period subjects continue the reached dose until final height. Administered as once daily subcutaneous injection; Initial dose 4 IU/m^2 body surface the first year, then 6 IU/m^2 body surface, the second year and finally 8 IU/m^2 body surface for 2 years (main period). In extension period subjects continue the reached dose until final height. Administered as once daily subcutaneous injection; Treatment with oestrogen was administered if spontaneous puberty had not occurred by age 12 years and was initiated in the extension period after at least four years of somatropin treatment
Intervention MeSH terms: Estrogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment