bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Subcutaneous Fat (Stage 2)
Condition: Subcutaneous Fat
Study type: Interventional
Phase: Phase 2

Summary: 
      The Stage 2 of this phase 2 study will be a randomized, single-blind, placebo-controlled,
      parallel, and multiple-dose study to assess the efficacy, safety, and subject satisfaction of
      CBL-514.
    

Detailed description: 
      This is the 2nd stage of a 2-Stage adaptive design, phase 2 study to evaluate the efficacy,
      safety and tolerability of CBL- 514 injection for reducing abdominal subcutaneous fat. Stage
      2 will be conducted as a single-blind, placebo-controlled study.

      CBL-514 will be administered via injection into the subcutaneous adipose layer on abdomen.
      Each subject will receive up to 4 treatments of allocated CBL-514 (2 mg/cm2) or placebo
      administered on abdomen, once every 4 weeks and complete 2 follow-up visits after the last
      treatment. The maximum dose is 600 mg per treatment depending on the level of fat
      accumulation on subject's abdomen.
    

Intervention name(s): CBL-514 Injection; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Formulated as an injectable CBL-514 solution at a concentration of 5 mg/mL.; Sodium Chloride (0.9% NaCl) placebo for injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Efficacy and Safety Study of Combination of Ginkgo Extract and Ginseng Extract(YY-162)in Children With ADHD
Condition: Mental Disorders
MeSH terms: Attention Deficit Disorder with Hyperactivity; Mental Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate clinical efficacy and safety of treatment with YY-162 in children
      with ADHD
    

Detailed description: 
      This is Double-Blind, two arms, multi-center, Interventional, 8 weeks study starting with
      YY-162(Combination of Ginkgo extract and Ginseng extract in children with ADHD. Assessment of
      efficacy and safety will be performed at the baseline, weeks 2,4, and 8. At the first visit,
      a full psychiatric history, demographic date and physical examination will be undertaken.
      Throughout the study, the following procedures, documentations and evaluations will
      performed; K-ARS, IOWA Conner's rating scale , CGI-S/I, ATA, Children's color trails test and
      stroop test, Intelligence test(from KEDI-WISC) and adverse event reporting.
    

Intervention name(s): YY-162; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): YY-162(Ginkgo extract 30mg+Ginseng extract 50mg) 1T/twice a day(bid) for 8weeks, po medication; Placebo 1T/twice a day(bid) for 8weeks, po medication
Other intervention name(s): Combination of Ginkgo extract and Ginseng extract
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ADHD(Attention Deficit Hyperactivity Disorder)
Safety and Efficacy of the CryoCor™ Cardiac Cryoablation System for the Treatment of Atrial Flutter
Condition: Atrial Flutter
MeSH terms: Atrial Flutter
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of right atrial
      intra-cardiac lesions created by transvenous catheter cryoablation in patients with atrial
      flutter.
    

Detailed description: 
      Catheter ablation of arrhythmias has become an accepted alternative to pharmacologic therapy.
      Cryoablation is a newer alternative to radiofrequency ablations. This study expands the prior
      pilot experience with the CryoCor™ Cardiac Cryoablation System to a larger cohort of patients
      with atrial flutter.
    

Intervention name(s): Catheter-based cardiac cryoablation
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: atrial flutter; cryoablation
Effectiveness of a Warm-Up With Foam Roller in Professional Basketball Players
Condition: Athletics Injury; Sports Physical Therapy
MeSH terms: Athletic Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to analyze the effectiveness of a foam roller warm-up on sports
      performance in professional basketball players.
    

Detailed description: 
      Twenty-two professional basketball players, divided into two randomized groups, carried out a
      specific warm-up for three months with a foam roller. Three measurements were made,
      pre-intervention, post-intervention at 12 weeks and a four-week follow-up. In these
      measurements reference data were taken for jumping, ankle dorsiflexion and balance. During
      this protocol, they performed three series of sixty seconds of application with thirty
      seconds of rest between series, three days a week and applied to the calf muscles,
      hamstrings, quadriceps, gluteus and TFL.
    

Intervention name(s): Foam Roller
Intervention type(s): Device
Intervention description(s): General Warm-up + Foam Roller
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomiced Controlled Trial
Masking: Single (Participant)
Primary purpose: Other
Keywords: Foam Roller; Performance; Warm-Up; Basketball
Efficacy of RIPC to Reduce AKI for Patients Undergoing PCI
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the present study is to determine if remote ischemic preconditioning reduces
      incidence of acute kidney injury in patients with reduced kidney function undergoing
      Percutaneous Coronary Intervention.
    

Detailed description: 
      Acute kidney injury negatively impacts on prognosis after PCI, and only hydratation have
      shown to reduce this complication.

      Remote ischemic preconditioning has been demonstrated to reduce periprocedural MI, while
      impact on aki remains to be assessed
    

Intervention name(s): Remote ischemic preconditioning; Sham remote ischemic preconditioning
Intervention type(s): Procedure; Procedure
Intervention description(s): four times 5-minute inflations of a blood pressure cuff to 200 mmHg around the upper non dominant arm (or if systolic pressure is more than 150 mmHg, inflation will reach 50 mmHg up per than baseline), followed by 5-minute intervals of reperfusion.; In the control group sham preconditioning will be performed with inflation of 10 mmHg more than baseline.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Interventional Study to Evaluate the Effect of the Oral Administration of L.Plantarum on Vaginal Microbiota
Condition: Vaginal Infection
Study type: Interventional

Summary: 
      Vaginal microbiota is abundantly colonized by Lactobacillus genera. When vaginal microbiota
      gets altered, opportunistic microorganisms may proliferate and become abundant species giving
      rise to dysbiosis.

      Probiotics are living organisms that provide the host certain benefits. Despite probiotics
      have been historically linked to intestinal microbiota, several research groups have
      published positive results for some Lactobacillus strains in vaginal microbiota. The
      Lactobacillus strain investigated in the presented project showed the ability to prevent
      recurrent vaginal Candidiasis in women with high vaginal candidiasis prevalence.

      Nowadays the Lactobacillus strain here investigated is commercialized as vaginal caps,
      however oral intake is widely preferred among consumers. Because of that, this study aims to
      determine whether this Lactobacillus strain is able to colonize vaginal microbiota when
      administered orally.
    


Intervention name(s): Lactobacillus plantarum
Intervention type(s): Dietary Supplement
Intervention description(s): Oral food supplement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: vaginal probiotic
Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Brain or Spine Diseases in Chinese Patients
Condition: Central Nervous System Diseases
MeSH terms: Nervous System Diseases; Central Nervous System Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if the contrast agent is effective and safe in the
      Magnetic Resonance Imaging (MRI) of brain or spine diseases in patients of Chinese origin.
    

Detailed description: 
      The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
      renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the
      trial.
    

Intervention name(s): Gadobutrol (Gadavist, Gadovist, BAY86-4875); Magnevist
Intervention type(s): Drug; Drug
Intervention description(s): 1,0M, intra venous injection at a dose of 0,1 ml/kg BW (= 0,1 mmol Gd/kg BW); 0,5M, intra venous injection at a dose of 0,2 ml/kg BW (= 0,1 mmol Gd/kg BW)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Gadovist; Gadavist; Contrast agent; Brain; Spine disease; Magnetic Resonance Imaging
Chemomechanical Caries Removal Using Papain Gel
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      To evaluate the efficacy of a papain-based gel in caries removal.
    

Detailed description: 
      Twenty children with at least two carious molar teeth without pulpal involvement participated
      in this randomized clinical trial. A total of 40 teeth were randomly divided into two
      treatment groups: group A, papain-based gel; and group B, conventional technique. Data
      collection included the time required for caries removal, need for local anesthesia, degree
      of discomfort, changes in the number of viable bacteria, and clinical evaluation of glass
      ionomer-cement restorations 6-month post-treatment.
    

Intervention name(s): Chemomechanical Caries Removal; Conventional method
Intervention type(s): Procedure; Procedure
Intervention description(s): Chemomechanical Caries Removal Using A Papain-Based Gel; Dental caries removal using rotatory instrument
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: dental caries; caries removal; chemomechanical caries removal
Evaluation of the Bioavailability of Pramlintide
Condition: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, open-label, crossover study to examine the bioavailability of
      pramlintide in normal weight and overweight subjects with type 1 and type 2 diabetes mellitus
      using insulin.
    


Intervention name(s): Pramlintide acetate
Intervention type(s): Drug
Intervention description(s): Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for injection. It consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative. The strength of pramlintide is 1.0 mg/mL for SC injection and 0.6 mg/mL for IV bolus injection.
Other intervention name(s): Symlin (pramlintide acetate)
Intervention MeSH terms: Pramlintide; Islet Amyloid Polypeptide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Feasibility of Sugammadex for General Anesthesia in Patients Undergoing Kidney and Pancreas Transplantation Surgery
Condition: Surgery
Study type: Interventional

Summary: 
      The effectiveness and safety of sugammadex were confirmed in pancreas kidney transplatation
      patients for reversal of deep neuromuscular blockade induced by rocuronium.Sugmmadex can
      reduce the length of PACU stay.
    

Detailed description: 
      A randomized clinical trial was conducted between 18 December 2020 and 21 April 2021.A total
      of forty patients who underwent simultaneous kidney and pancreas transplantation surgery.All
      of the patients were randomized divided into normal saline group (Group C, n =20) and
      sugammadex group (Group S, n =2). Group C did not receive any neuromuscular block
      antagonist（NMBA). Group S received sugammadex 4 mg kg-1 at 1-2 post-tetanic counts for
      reversal of rocuronium NMB. The neuromuscular blockade was monitored via a peripheral nerve
      stimulator TOF watch SX acceleromyography. Patients received adequate doses of rocuronium to
      maintain an enough neuromuscular blockade during the whole surgery. Serum creatinine (CREA),
      blood glucose (Glu) levels were measured at T0, 8h(T1), 12h(T2), 36h(T3), 60h(T4), 84h(T5),
      and 108h(T6), and blood pressure (MAP), heart rate (HR), blood oxygen saturation (SpO2) and
      stay time in PACU were recorded.
    

Intervention name(s): Sugammadex; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Sugammadex is a modified γ-cyclodextrin designed selectively to reverse the effects of the neuromuscular blocking agents (NMBAs) rocuronium and vecuronium; Equal doseage of normal saline was injected to reverse the NMB.
Other intervention name(s): Bridion
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All of the patients were randomized divided into normal saline group (Group C, n =20) and sugammadex group (Group S, n =2). Group C did not receive any neuromuscular block antagonist（NMBA)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sugmmadex;; SPK
Prenatal Cocaine, Nasal Oxytocin, and Maternal Psychophysiology
Condition: Substance Abuse Problem; Pregnancy
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research is to study the effects of nasal oxytocin administration on
      maternal behaviors that may be influenced by cocaine use during pregnancy. 32 mothers with
      prenatal use of cocaine during the current pregnancy will be studied at 3-6 months
      postpartum, when they will complete 3 study visits, a 2-week double-blind trial of twice
      daily nasal spray (oxytocin or placebo) and 4 telephone interviews. All information collected
      is confidential.
    

Detailed description: 
      Participation for mothers when they are 3-6 months postpartum includes:

        -  Visit 1: Questionnaires and interviews about participants' health, pregnancy, moods,
           psychological history and drug use during pregnancy and postpartum.

        -  Visit 2: Pregnancy & drug tests (results are confidential), blood samples and vital
           signs, video-taped mother-infant interaction, speech task, instruction re: using nasal
           spray (oxytocin or placebo) & self-administration of first nasal spray dose, followed by
           90 minutes of monitoring.

        -  At-home nasal spray: Twice daily (before breakfast and supper) nasal spray
           self-administration for 14 days.

        -  Visit 3: Pregnancy & drug tests (results are confidential), blood samples and vital
           signs, video-taped mother-infant interaction, speech task, interviews and questionnaires
           about mothers' experience with the nasal spray, and changes in mood or physical
           discomfort during the 2-weeks when taking the nasal spray.

        -  3 telephone interviews while subjects are taking nasal spray, and 1 post-trail telephone
           follow-up.
    

Intervention name(s): Syntocinon treatment; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 24 IU twice daily (A single dose will be delivered consisting of 6 intranasal insufflations (3 in each nostril) which is equivalent to a total of 24 international units (IU) of oxytocin twice daily).; Placebo nasal spray vials will contain the same ingredients in the nasal preparation, but without oxytocin.
Other intervention name(s): Nasal Oxytocin treatment
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Cocaine; Mothers; Pregnant women; Postpartum women; Oxytocin; Substance use disorders; Substance abuse; Prenatal substance use; stress
24 Months Safety and Efficacy Study of AADvac1 in Patients With Mild Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the safety and efficacy of AADvac1 in the treatment of patients with
      mild Alzheimer's disease.

      60% of participants will receive AADvac1 and 40% of participants will receive placebo.
    

Detailed description: 
      Alzheimer's disease (AD) is a chronic progressive neurodegenerative disorder of the brain.
      Over the course of the disease, pathological proteins accumulate in the brain, damaging
      neurons, thus causing them to lose their connections and die.

      Currently available treatments are designed to compensate for the neurotransmitter loss
      caused by the disease without affecting the disease process itself.

      AADvac1 is designed to raise antibodies against pathological tau protein (the primary
      constituent of neurofibrillary pathology in AD). These antibodies are expected to prevent tau
      protein from aggregating, to facilitate the removal of tau protein aggregates and prevent the
      spreading of pathology, slowing or halting the progress of the disease.
    

Intervention name(s): AADvac1; Placebo
Intervention type(s): Biological; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: vaccine; tau protein; active; immunization; KLH; immunotherapy; tau
Incontinence and MRI Results in Children With Cerebral Palsy
Condition: Cerebral Palsy; Lower Urinary Tract Symptoms
MeSH terms: Paralysis; Cerebral Palsy; Lower Urinary Tract Symptoms
Study type: Observational

Summary: 
      More than 50 % of children and adults with cerebral palsy experience lower urinary tract
      symptoms (LUTS). This can negatively influence quality of life of the child and the total
      social environment.

      Previous research demonstrated that the brain lesion, characteristic for cerebral palsy (CP),
      is a prognostic factor for the functional abilities of a child with CP. Previous research
      within our department demonstrated functional impairment as a risk factor for incontinence.
      This demonstrates an indirect connection between the brain lesion and incontinence of a child
      with CP. However, this connection isn't alway correct as some children with high
      functionality also demonstrate incontinence.

      As bladder control is also regulated by higher brain centers, the present study wants to
      investigate a direct connection between the brain lesion of the child, visible by means of
      MRI, and the incontinence status of the child. .
    

Detailed description: 
      The current study is a cross-sectional observational study in which a correlation is
      investigated between known anatomical MRI results and the continence status of a child with
      CP.

      Although neuroimaging isn't seen as a requirement for the definition and diagnosis of CP2,
      MRI imaging is often part of diagnostic evaluation. The Surveillance of Cerebral Palsy in
      Europe (SCPE) working group composed the MRI classification system or MRICS classifying
      neuroimaging results in maldevelopments, predominant white matter injury, predominant grey
      matter injury, miscellaneous and normal. These results will be correlated with results of the
      validated Vancouver symptoms score for dysfunctional elimination syndrome.
    

Intervention name(s): Vancouver symptom score for dysfunctional elimination syndroms; Magnetic resonance imaging
Intervention type(s): Other; Other
Intervention description(s): Validated questionnaire concerning bladder and bowel symptoms; Known MRI results of the patient file
Other intervention name(s): VSSDES; MRI
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children with cerebral palsy attending yearly or half yearly follow-up consultation
      
Keywords: cerebral palsy; lower urinary tract symptoms; Magnetic resonance imaging; brain lesion; incontinence
Functional Ingredients: Effect in Gastrointestinal System
Condition: Overweight; Diabetes; Constipation
MeSH terms: Overweight; Constipation
Study type: Interventional

Summary: 
      The addition of fructans or unripe banana flour to frozen meals can change the hormonal
      parameters related to hunger and satiety, improve the bowel movements and increase in colonic
      bacteria population measured by microbiological determinations (qPCR). The inulin no can
      change bowel movements and increase in colonic bacteria population measured by
      microbiological determinations (qPCR)
    

Detailed description: 
      Non-transmissible chronic diseases have been constantly related to the consumption of diets
      with inadequate nutrient input; at the same time, the ingestion of unavailable carbohydrates
      have presented an inverse relationship with the risk for these diseases. Among these
      carbohydrates is inulin, a fructan considered as a prebiotic and the unripe banana flour,
      rich in resistant starch, which may contribute to the intestinal health.

      This study evaluated the effect of regular intake of frozen soups added functional
      ingredients (fructans and unripe banana flour) by heath volunteers, about gastrointestinal
      hormones, satiety and bowel movements.
    

Intervention name(s): Ready-to-eat frozen soups added unripe banana flour; Ready-to-eat frozen soups added maltodextrin; Ready-to-eat frozen soups added inulin; Ready-to-eat frozen soups added nisin
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Ready-to-eat frozen soups added unripe banana flour (18 portions; 3 times/week); Ready-to-eat frozen soups added maltodextrin (18 portions; 3 times/week); Ready-to-eat frozen soups added inulin (18 portions; 3 times/week); Ready-to-eat frozen soups added nisin (18 portions; 3 times/week)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Hunger and satiety; Hormones gastrointestinal; Bowel movements