bioihbjkbjnl/mcl2 huggingface dataset:
Transcutaneous Electrical Acupoint Stimulation(TEAS) for Hypotension After Spinal Anesthesia in Parturients
Condition: Hypotension
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effect of TEAS on hypotension after spinal
      anesthesia in patients undergoing cesarean section
    

Detailed description: 
      Patients were randomly assigned to 3 groups, receiving TEAS , non-acupoint stimulation or
      no-stimulation after spinal anesthesia respectively. 1.4 ml of bupivacaine mixed with 0.2ml
      of 50% glucose was given for spinal anesthesia under lateral position. Then the patient was
      switched to supine position and the OR table was tilted to the left for 15 degree. The
      sensory loss level was assessed. The blood pressure and heart rate every 2min were recorded
      for 30min after spinal anesthesia. The adverse events and use of ephedrine adverse events
      were recorded as well.
    

Intervention name(s): TEAS; Non-acupoint stimulation
Intervention type(s): Other; Other
Intervention description(s): Electric stimulation was given through electrode attached to specific acupoints; Electric stimulation was given through electrode attached to the shoulder
Other intervention name(s): Transcutaneous electrical acupoint stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hypotension; spinal anesthesia; cesarean
Bosutinib In Subjects With Renal Impairment
Condition: Renal Disease, End-Stage; Renal Insufficiency, Chronic; Renal Insufficiency, Acute
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic; Acute Kidney Injury; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two-staged study of a single dose of 200 mg of bosutinib given to subjects with
      renal impairment and matching healthy volunteers. In Stage 1, only subjects with severe renal
      impairment and subjects with normal renal function will be enrolled. Subjects with mild and
      moderate renal impairment will be enrolled in Stage 2 if the results from Stage 1 suggest a
      substantial difference in PK profiles between subjects with severe renal impairment and
      subjects with normal renal function.
    


Intervention name(s): Bosutinib; Bosutinib; Bosutinib; Bosutinib
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single dose of 200 mg of bosutinib in subjects with normal renal function; Single dose of 200 mg of bosutinib in subjects with mild renal impairment; Single dose of 200 mg of bosutinib in subjects with moderate renal impairment; Single dose of 200 mg of bosutinib in subjects with severe renal impairment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal impairment; healthy volunteers
The Association of Pelvic Organ Prolapse Severity and Urinary Symptoms/Sexual Function
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Observational

Summary: 
      Women with pelvic organ prolapse often accompany with urinary symptoms or sexual dysfunction,
      and analyzing the association will be helpful to identify the indication of proper
      management. Therefore, the aim of this study is to identify the above associations.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        all women with pelvic organ prolapse , especially with cystocele, in our outpatient
        department or the room of urodynamic studies.
      
Keywords: pelvic organ prolapse; urinary symptoms; sexual function
Evaluation of RC28-E Injection in Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a non-randomized, open-label, multicenter, 48-week study to investigate the efficacy,
      safety and pharmacokinetics of RC28-E injection in the treatment of patients with diabetic
      macular edema.
    


Intervention name(s): intravitreal injection of RC28-E; Conbercept
Intervention type(s): Biological; Biological
Intervention description(s): a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF; KH902(Conbercept）
Intervention MeSH terms: RC28-E protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Metabolic Effects of Ultra-endurance Exercise and Training Under Low or High Glycaemic Index-carbohydrate Diets.
Condition: A Randomised Counter-balanced Intervention Study in Endurance Athletes
Study type: Interventional

Summary: 
      A randomised counter-balanced intervention study in endurance athletes
    

Detailed description: 
      To characterise glycaemic, dietary, physiological, and metabolic responses around intense
      endurance exercise and training in ultra-endurance athletes.

      Primary objective

      • Detail the proportion of time spent in glycaemic ranges over a prolonged period of training
      under the influence of different GI diets in Ultra-endurance athletes.

      Secondary Objectives

        -  Characterise physiological responses to differing GI diets during a period of extensive
           endurance exercise through hormonal markers.

        -  Observe the influence of differing GI diets on the impact of endurance performance and
           short term recovery from endurance exercise, detailing the influence of different GI
           carbohydrate on the restoration of performance output.

        -  Observe the perception of wellness and gut discomfort using either high or low GI diets
           supplemented with high or low GI carbohydrates.
    

Intervention name(s): Isomaltulose; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Diet will be supplemented with a beverage containing Isomaltulose as a carbohydrate source.; Diet will be supplemented using a beverage containing Maltodextrin.
Other intervention name(s): Palatinose
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: randomised counter-balanced
Masking: Single (Participant)
Primary purpose: Basic Science
Safety and Efficacy of APD356 in the Treatment of Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a research study of an investigational drug, APD356, a novel, selective 5-HT2c
      receptor agonist, in clinical development as a potential treatment for obesity.

      The purpose of this study is to obtain a preliminary assessment of the safety and efficacy of
      APD356, when administered daily for 12 weeks, in obese subjects who are otherwise healthy.
      Subjects who are on concomitant medications for control of hypertension or blood lipids may
      qualify.
    

Detailed description: 
      This is a double-blind, placebo-controlled, randomized, parallel group study. Three different
      doses of APD356 or placebo will be administered daily for 12 weeks, to obese, male and
      nonpregnant, nonlactating, female volunteers, aged 18 to 65 years. Approximately 400 subjects
      will be enrolled.
    

Intervention name(s): APD356
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Serotonin; 5-HT2c; Satiety; Obesity; Appetite suppressant; Weight Loss; Overweight
[18F]MK-6240 Positron Emission Tomography (PET) Tracer First-in-Human Validation Study (MK-6240-001)
Condition: Alzheimer's Disease; Amnestic Mild Cognitive Impairment
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      This 2-part, open-label study was designed to investigate the safety, tolerability, and
      efficacy of [18F]MK-6240, a Positron Emission Tomography (PET) imaging agent, for the
      quantification of neurofibrillary tangle (NFT) deposition in the brain. Brain NFT deposition
      is a pathologic finding in Alzheimer's Disease (AD), with brain NFT density shown to
      correlate with the severity of cognitive impairment in AD. The objectives of the study
      include performing the following with respect to [18F]MK-6240 administered as a PET imaging
      agent: 1) assess safety and tolerability; 2) determine radiation safety profile; 3) determine
      optimal imaging protocol parameters for quantification of brain NFTs in AD; 4) compare tracer
      binding in brain PET scans from participants with AD, participants with amnestic mild
      cognitive impairment (MCI) and healthy elderly participants; and 5) evaluate intra-subject
      test-retest (T-RT) variability of tracer uptake in brain regions of interest.
    


Intervention name(s): [18F]MK-6240, ~185 MBq; [18F]MK-6240, ~160 MBq
Intervention type(s): Drug; Drug
Intervention description(s): IV dose of ~185 MBq [18F]MK-6240; IV dose of ~160 MBq [18F]MK-6240
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
T Cell Repertoire Analysis of Immune Mediated Skin Diseases
Condition: Psoriasis; Mycosis Fungoides
MeSH terms: Mycoses; Mycosis Fungoides; Psoriasis; Skin Diseases
Study type: Observational

Summary: 
      This study is designed to identify the cells of the immune system that cause skin disease
      such as psoriasis and mycosis fungoides. Blood samples from many patients will be compared in
      hopes of finding common cells and molecules responsible for skin diseases. Results of this
      study will increase our knowledge about immune mediated skin disease.
    

Detailed description: 
      The aim of the study is to characterized the T cell repertoire of individuals with immune
      mediated skin disease (e.g. psoriasis and mycosis fungoides). Peripheral blood with be
      collected from volunteers with psoriasis, mycosis fungoides and age matched controls. Fifteen
      tablespoons of blood will be collected prior to the initiation of treatment and again after
      the patient shows a clinical response to treatment. The time between blood draws will be no
      less than 3 months. There will be no more than two blood draws per patient. Blood samples
      will be used to determine the patient's HLA haplotype via PCR and DNA sequencing. After the
      patient's haplotype has been established the activated T cell repertoire will be analyzed for
      clonal expansions. Clonal expansions in the T cell repertoire will be determined by
      immunoscope analysis, which is a PCR based technique.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects aged 18 years to 55 years who have an immune mediated skin disease, such as
        psoriasis or mycosis fungoides, and age-matched controls (subjects who do not have an
        immunce midiated skin disease).
      
Biospecimen description: 
      Fifteen tablespoons of blood will be collected prior to the initiation of a treatment and
      again after the patient shows a clinical response to a treatment. The time between blood
      draws will be no less than 3 months. There will be no more than two blood draws per patient.

      Blood samples will be used to determine the patient's HLA haplotype via PCR and DNA
      sequencing. After the patient's haplotype has been established the activated T cell
      repertoire will be analyzed for clonal expansions. Clonal expansions in the T cell repertoire
      will be determined by immunoscope analysis, which is a PCR based technique.
An Open-label, Single-dose, Intravenous Administration Study of ONO-2745/CNS 7056 in Subjects With Chronic Hepatic Impairment
Condition: Hepatic Impairment; Healthy
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate and compare the pharmacokinetics and safety of ONO-2745/CNS 7056 in subjects with
      the hepatic impairment and matched healthy subjects.
    

Detailed description: 
      In Part One, 8 subjects with moderate hepatic impairment (Child Pugh Scale B) and 8 matched
      healthy subjects will be enrolled. In Part 2, 8 subjects with mild hepatic impairment
      (Child-Pugh Scale A) and 8 matched healthy subjects will be enrolled. In Part 3, 3 subjects
      with severe hepatic impairment (Child-Pugh Scale C) will be enrolled. Parts 2 and 3 will only
      be initiated if the criteria per protocol is met in Part One. The pharmacokinetics and safety
      profiles will be compared between hepatic impaired subjects and healthy subjects.
    

Intervention name(s): ONO-2745 /CNS 7056
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adult healthy subjects will be matched with individual subjects by age (± 5 years, gender, and BMI (± 15%)
High Fiber Rye Foods for Weight and Body Fat Reduction
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The overall aim of this study is to investigate whether a diet rich in rye fiber from
      wholegrain rye, compared to refined wheat, as part of a hypocaloric diet leads to larger
      weight loss and lower body fat content after 12 weeks of intervention. Furthermore the study
      will investigate the effect on appetite as a potential underlying mechanism for differences
      in weight loss and body fat reduction.
    


Intervention name(s): Wholegrain rye; Refined wheat
Intervention type(s): Other; Other
Intervention description(s): Cereal products based on wholegrain rye; Cereal products based on refined wheat
Other intervention name(s): Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy
Condition: Chronic Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 3

Summary: 
      This is one of two replicate randomized, double-blind, placebo-controlled, parallel arm
      trials to determine the safety and efficacy of two different dose levels of SEL-212 compared
      to placebo. 112 and 153 patients, stratified as to the presence or absence of tophi, were
      randomized in a 1:1:1 allocation ratio prior to Baseline to receive treatment with one of two
      dose levels of SEL-212 or placebo every 28 days for approximately 6 months in each trial
      respectively (SEL-212/301 and SEL-212/302). Analysis of primary and key efficacy will be
      performed at Day 28 of Treatment Period 6. Safety was monitored throughout the study.
    

Detailed description: 
      This is one of two replicate randomized, double-blind, placebo-controlled, parallel arm
      trials to determine the safety and efficacy of two different dose levels of SEL-212 compared
      to placebo. 112 and 153 patients, stratified as to the presence or absence of tophi, were
      randomized in a 1:1:1 allocation ratio prior to Baseline to receive treatment with one of two
      dose levels of SEL-212 or placebo every 28 days for approximately 6 months in each trial
      respectively (SEL-212/301 and SEL-212/302). The SEL-212 doses differed as to the SEL-110.36
      component. Participants received SEL-037 administered at a dose of 0.2 mg/kg via intravenous
      (IV) infusion immediately after receiving SEL-110.36 at a dose of either 0.1 mg/kg (SEL-212
      low-dose) or 0.15 mg/kg (SEL-212 hig-dose) via IV infusion. The placebo consisted of normal
      saline.

      Upon completion of the 6-month double-blinded, placebo-controlled portion of the study,
      SEL-212/301 continued in a blinded, placebo-controlled 6-month extension. This provided up to
      12 months of continuous treatment with SEL-212 in a placebo controlled fashion.

      Placebo subjects who completed both phases of the study will be offered enrollment in an
      open-label extension study for treatment with SEL-212 (SEL-212/303).

      Efficacy assessments were conducted at intervals that are appropriate to determine treatment
      effect with samples for the primary endpoint drawn during Treatment Period 6. Safety was
      monitored throughout the study with an independent data safety monitoring board (DSMB).
    

Intervention name(s): SEL-212 low-dose; SEL-212 high-dose; Normal Saline
Intervention type(s): Drug; Drug; Other
Intervention description(s): IV infusion of SEL-212 low-dose every 28 days for a total of up to 12 infusions; IV infusion of SEL-212 high-dose every 28 days for a total of up to 12 infusions; IV infusion of Normal Saline every 28 days for a total of up to 12 infusions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Subcutaneous Adaption and Cosmetic Outcome Following Caesarean Delivery
Condition: Caesarean Delivery
Study type: Interventional

Summary: 
      This is a double blinded randomized study investigating if subcutaneous adaption has an
      impact on cosmetic outcome after Caesarean delivery.
    


Intervention name(s): subcutaneous adaption
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Wound closure; cosmetic outcome
Phase Ⅳ Clinical Trial to Evaluate of Renamezin in Patients With Chronic Renal Failure.
Condition: Chronic Renal Failure
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      Renamezin Capsule (an oral adsorbent) lowers indoxyl sulfate levels in patient with chronic
      renal failure.

      120 patients with chronic renal failure(baseline serum creatinine:1.5-5.0mg/dl).

      Renamezin is administered 6.0mg/day. The treatment period is 2 months. The change in serum
      indoxyl sulfate will be evaluated.
    


Intervention name(s): Renamezin capsule
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of QMF149 (150/80 µg) Compared With MF Twisthaler® (200 µg) in Patients With Asthma
Condition: Mild Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the trial was to evaluate efficacy and safety of QMF149 150/80 microgram o.d.

      delivered via Concept1 compared to MF 200 microgram o.d., delivered via Twisthaler® in terms
      of lung function and symptom control in poorly (ie inadequately) controlled asthma patients.
      This study was to assess contribution of LABA as an add-on therapy to low dose ICS
      monotherapy.
    

Detailed description: 
      The primary objective of this study was to demonstrate the superiority of QMF149 150/80
      microgram o.d. (in the evening) delivered via Concept1 compared with MF 200 microgram o.d.
      (in the evening) delivered via Twisthaler® in terms of trough FEV1 after 12 weeks of
      treatment in adults and adolescents. The key secondary objective of this study was to
      demonstrate the superiority of QMF149 150/80 microgram to MF 200 microgram o.d. in terms of
      ACQ-7 after 12 weeks of treatment.
    

Intervention name(s): QMF149 150/80 μg; MF 200 μg
Intervention type(s): Drug; Drug
Intervention description(s): QMF149 150/80 μg o.d via Concept1; MF 200 μg o.d. via Twisthaler®
Other intervention name(s): Indacaterol acetate/Mometasone furoate; Mometasone furoate
Intervention MeSH terms: Mometasone Furoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Phase III, blinded, QMF149, Mometasone furoate (MF), mild asthma, Adolescent, adult
Health Status and Cardiovascular Stress of Veteran Soccer Players
Condition: Health Status; Stress
Study type: Observational

Summary: 
      This study shall provide missing descriptive data on health status of veteran players and
      potential preventive effects of soccer at an age of 40 to 60 years. The investigation
      represents a cross-sectional examination of cardiovascular parameters and metabolic stress
      induced by training and competition. Additionally, orthopedic and other medical risks are to
      be revealed, and options should be developed to minimize these risks, e.g. by preventive
      measures included in training or rule modifications.
    

Detailed description: 
      Facing the demographic trends in Western societies there is an expected increase in interest
      in soccer for males between 40 and 60 years. Positive effects of such an activity on health
      can be suspected based on some studies and analogous conclusions. However, no sufficient
      database is available yet. Moreover, the range of cardiovascular risk factors or pre-existing
      diseases for this specific population is not known.

      This study shall provide missing descriptive data on health status of veteran players and
      potential preventive effects of soccer at an age of 40 to 60 years. The investigation
      represents a cross-sectional examination of cardiovascular parameters and metabolic stress
      induced by training and competition. Additionally, orthopedic and other medical risks are to
      be revealed, and options should be developed to minimize these risks, e.g. by preventive
      measures included in training or rule modifications.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        veteran soccer players from Saarland County, Germany
      
Keywords: soccer; prevention; veteran athletes; exercise; Cardiovascular