bioihbjkbjnl/mcl2 huggingface dataset:
Optimal Number of To-and-fro Motion in EUS-guided Fine Needle Aspiration for Pancreatic Masses
Condition: Pancreatic Masses
Study type: Interventional
Phase: Phase 3

Summary: 
      EUS-FNA is the standard of care for diagnosing pancreatic masses. According to the operator's
      preference, EUS-FNA with suction or without suction technique has been used. To date, little
      is known about optimal number of to-and-fro motion during each needle pass. As usual 10-15
      to-and-fro motions was used for EUS-FNA with suction technique. Theoretically, more number of
      to-and-fro motions may be required in EUS-FNA without suction. In this circumstance, the
      contamination of blood in specimen and possible adverse event may occur. To determine optimal
      number of to-and-fro motion in EUS-guided FNA for pancreatic masses in terms of with suction
      or without suction, this prospective single-blinded randomized trial was conducted.
    

Detailed description: 
      For this prospective single-blinded randomized trial, two 10cc syringes was prepared. Two
      syringe was provided as same performance. However, one syringe is falsely made as suction
      syringe (fake one). During EUS-FNA, two syringe is randomly assigned and loaded by a nurse.
      Thus, operator was blinded which syringe is with suction or without suction.

      First hypothesis: There is difference in the diagnostic accuracy of pancreatic masses
      according to EUS-FNA with suction or without suction/ different number of to-and-fro motion.

      Second hypothesis: There is difference in the amount of blood in samples obtained by EUS-FNA
      with suction or without suction/ different number of to-and-fro motion.
    

Intervention name(s): EUS-FNA; EUS-FNA with suction; EUS-FNA without suction
Intervention type(s): Procedure; Device; Device
Intervention description(s): EUS-FNA with suction/10, 15, 20 to-and-fro motion vs. EUS-FNA without suction/10, 15, 20 to-and-fro motion Visual assessment as stoping rule: 20 to-and-fro motion at different site will be performed when EUS-FNA sampling with 10, 15, 20 to-and-fro motion is unsatisfactory.; For this prospective single-blinded randomized trial, two 10cc syringes was prepared. Two syringe was provided as same performance. However, one syringe is falsely made as suction syringe (fake one). During EUS-FNA, two syringe is randomly assigned and loaded by a nurse. Thus, operator was blinded which syringe is with suction or without suction.; For this prospective single-blinded randomized trial, two 10cc syringes was prepared. Two syringe was provided as same performance. However, one syringe is falsely made as suction syringe (fake one). During EUS-FNA, two syringe is randomly assigned and loaded by a nurse. Thus, operator was blinded which syringe is with suction or without suction.
Other intervention name(s): FNA with or without suction; FNA with suction; FNA without suction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: EUS, EUS-FNA, Pancreatic masses
LCoMotion. Learning, Cognition and Motion. Effect of a Four Month School-based Cluster-randomized Intervention
Condition: Cognitive Function
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of a four months school-based physical
      activity intervention on cognition, academic achievement, physical activity and aerobic
      fitness in 12-15 year old adolescents.
    


Intervention name(s): Physical activity intervention; Usual practice
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Physical activity during recess, in academic subjects, active transportation and PA home work; Normal curriculum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effect Of Carvedilol Versus Metoprolol On Glycemic Control In Patients With Type II Diabetes And Hypertension
Condition: Hypertension
MeSH terms: Hypertension; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluation of the effect of two different antihypertensive treatments on control of glucose
      in Type II diabetic patients with high blood pressure
    


Intervention name(s): carvedilol; metoprolol
Intervention type(s): Drug; Drug
Other intervention name(s): carvedilol
Intervention MeSH terms: Metoprolol; Carvedilol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: hypertension; beta-blockers; Type 2 diabetes
Effectiveness of BufferGel as a Vaginal Contraceptive
Condition: Pregnancy
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      BufferGel is a new contraceptive gel designed to be used with a diaphragm. In addition to
      preventing pregnancy, BufferGel may also prevent some types of sexually transmitted diseases
      (STDs). This study will compare BufferGel to Gynol II, a currently available contraceptive
      gel.
    

Detailed description: 
      Vaginal acidity is thought to be one means by which the vagina prevents overgrowth or
      colonization by harmful microbial flora. Sperm and many STD pathogens, including HSV-1 and
      HSV-2, Neisseria gonorrhoeae, Treponema pallidum, Haemophilus ducreyi, and a variety of
      bacterial vaginosis-associated bacteria, are inactivated at pH less than 5 in vitro.
      BufferGel, a vaginal spermicide and microbicide, is an acidic buffer that maintains the
      vagina at or near its natural state of mild acidity. Formulated at vaginal pH (pH 3.9),
      BufferGel prevents or limits the semen-induced rise in vaginal pH. Carbopol 974P, the
      buffering agent in BufferGel, is a high molecular weight, cross-linked, polyacrylic acid used
      as a gelling or tableting agent in many pharmaceuticals; it has a well-documented record of
      mucosal safety in animals and humans. This study will determine the safety and contraceptive
      efficacy of BufferGel spermicide used with a diaphragm compared to Gynol II spermicide used
      with a diaphragm. The study will also measure the frequency of bacterial vaginosis, urinary
      tract infections, and cervical lesions in women using BufferGel compared with Gynol II.

      Participants in this study will be fitted for a diaphragm and randomized to receive either
      BufferGel or Gynol II. All participants will be instructed on the use of the test product
      with the diaphragm. Participants will be followed through 6 menstrual cycles (approximately 7
      months) and will have 4 study visits and one study phone call. Some participants may enroll
      in an extended version of the study and be followed for an additional 6 cycles and 2
      additional study visits. Study visits will include a gynecologic exam, Pap smear, and blood
      and urine tests. Participants will be asked to keep a diary to record information on product
      use. Some participants may also be asked to enroll in a colposcopy substudy. These
      participants will undergo colposcopy at study entry and after cycles 1, 3 and 6.
    

Intervention name(s): BufferGel
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Contraception; Nonoxynol 9; Microbicide; Spermicide
Comparison of Epinephrine-lidocaine Solution and Dexmedetomidine -Lidocaine Solution
Condition: Craniotomy
Study type: Interventional

Summary: 
      Scalp infiltration with Epinephrine- containing lidocaine solution is common method for
      craniotomy but it may result in transient but significant hypotension in patients undergoing
      neurosurgery. Dexmedetomidine, a potent alpha2 adrenoceptor agonist which dose-dependently
      reduces arterial blood pressure and heart rate, decreases the hemodynamic and catecholamine
      response, and dexmedetomidine has an effect of peripheral vasoconstriction thus it is thus
      theologically appropriate for reducing bleeding during scalp incision in craniotomy.

      The aim of this study is to compare the effect of dexmedetomidine-lidocaine solution on
      hemodynamic response, scalp bleeding to epinephrine-lidocaine solution.
    


Intervention name(s): scalp infiltration solution; scalp infiltration solution
Intervention type(s): Drug; Drug
Intervention description(s): Dex group: Dexmedetomidine 2mcg/ml-containing 1% lidocaine scalp injection by neurosurgeon(dosage: according to incision length); 1:100000 epinephrine-containing 1% lidocaine scalp injection by neurosurgeon(dosage: according to incision length)
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dexmedetomidine; epinephrine; lidocaine; scalp infiltration; craniotomy
Glutamatergic Modulation of Motivation Enhancement: A Pilot Feasibility Trial
Condition: Cocaine Use Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study evaluates the feasibility of a treatment paradigm that involves naturalistic
      cocaine use opportunities in the context of psychotherapy aimed at utilizing these
      opportunities therapeutically.
    


Intervention name(s): infusion of NMDA antagonist
Intervention type(s): Drug
Intervention description(s): 52 minute infusion
Other intervention name(s): NMDA antagonist
Intervention MeSH terms: N-Methylaspartate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Radiofrequency Female External Genital Region: a Clinical Trial
Condition: Dissatisfaction Appearance of the External Genitalia
Study type: Interventional
Phase: Phase 2

Summary: 
      OBJECTIVES: The aim of the study is to evaluate the clinical response of the non-ablative
      radiofrequency (RF) in the outcome cosmetic female external genital and its effect in the
      sexual function. METHODS: Single blind randomized controlled trial. Sample of 43 women (29
      sexual active) with insatisfaction appearance of the external genitalia, 21 (14) in the study
      group and 22 (15) in the control group. The protocol consisted in 8 sessions of RF once a
      week. The instruments of evaluation were photo (taken before the first session and eight days
      after the last session), which were evaluated by the patient and by three health professional
      (that did not know the group); by the 3 points Likert scale (unsatisfied, unchanged,
      satisfied) and (worst, unchanged, improved). The sexual function was evaluated by the Female
      Sexual Function Index (FSFI) before and after, and analyzed by the T Test of Student. The
      patients' satisfaction and the health professionals' evaluation were analyzed by the
      chi-squared test and by binomial comparison inter-group and intra-group.
    


Intervention name(s): Radiofrequency; Radiofrequency - OFF
Intervention type(s): Device; Device
Intervention description(s): The application of RF was through Tecatherap-VIP unit (VIP-Eletromedicina, Argentina) with bipolar method, using a gauntlet of 2cm, and the coupling electrode, which was located in the sacral region (fig x). For the application, participants were placed in a supine position with legs in lithotomy position, it was used water soluble gel for coupling and slide of the gauntlet. The application in external labia majora was made in the caudal-cranial direction, with constant movement and electrode lightly pressed. (fig) During the session, the heat level was monitored verbally and by infrared digital thermometer. The intensity was gradually increased, and at the time when the temperature reached values between 39-41ºC, the intensity was reduced two points and the procedure was maintained for two minutes.; The treatment protocol for the control group was identical, differing only in relation to the RF equipment, which was turned off, but a water-soluble gel was used, heated by a resistor, preventing the patient from knowing to which group she belonged. Just the physiotherapist who performed the procedure knew which group the patient belonged to.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Treatment by Pulsed Radio Frequency, Collagen, Female
Single-Ascending Dose Study of BIIB054 in Healthy Participants and Early Parkinson's Disease
Condition: Parkinson's Disease; Healthy
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the safety and tolerability of a range of
      single BIIB054 doses, administered as a single intravenous (IV) infusion, in healthy
      participants and participants with early Parkinson's disease (PD). Secondary objectives of
      the study are to assess the serum pharmacokinetics (PK) profile of BIIB054 after single-dose
      administration and to evaluate the immunogenicity of BIIB054 after single-dose
      administration.
    

Detailed description: 
      Only healthy participants will be enrolled in Cohorts 1 through 6. Only participants with
      early PD will be enrolled in Cohort 7
    

Intervention name(s): BIIB054; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): IV infusion; IV infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: alpha synuclein; PD
Effect of Different Bandage Interface Pressures on Breast Cancer Related Lymphedema
Condition: Lymphedema of Upper Limb; Breast Cancer Lymphedema; Edema Arm
MeSH terms: Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema
Study type: Interventional

Summary: 
      The goal of this randomised comparison study is to compare different bandage interface
      pressures in individuals with breast cancer related lymphedema

      The main questions it aims to answer are:

        -  Is high or low bandage pressure effective in reducing edema and soft tissue thickness?

        -  do bandages applied with high or low bandage pressure comprimise sleep, comfort or
           subjective benefit from treatment?

      Participants will recieve complex decongestive physiotherapy. Bandage will apply high or low
      pressure. Effects of high and low bandage interface pressures will compare
    

Detailed description: 
      The aim of this study was to evaluate the effect of compression bandage applied with
      different pressures on skin and subcutaneous thickness in individuals with breast
      cancer-related lymphedema.

      individuals with stage 2 unilateral lymphedema participated in the study. Skin and
      subcutaneous thicknesses, extremity volumes, sleep quality, treatment benefit, comfort during
      treatment were evaluated respectively by ultrasound from 6 reference points as dorsum of
      hand, wrist volar, forearm dorsum, forearm volar, arm dorsum, arm volar, volumetric
      measurement, Pittsburgh Sleep Quality Index, Patient Benefit Index-Lymphedema, and visual
      analog scale. Complex decongestive physiotherapy was applied to individuals randomly divided
      into two groups: low (20-30 mmHg) and high bandage pressure (45-55 mmHg). Individuals were
      evaluated before treatment, at 1st, 10th session, end of treatment, and at 3 months
      follow-up.
    

Intervention name(s): complex decongestive physiotherapy with low pressure compression bandage; complex decongestive physiotherapy with high pressure compression bandage
Intervention type(s): Other; Other
Intervention description(s): both group received complex decongestive physiotherapy consist of manual lymph dranaige, skin care, exercise and compression bandage. Every component except compression bandage applied exacly the same to both group. Compression bandage applied with low bandage interface pressure (20-30 mmHg); complex decongestive physiotherapy consist of manual lymph dranaige, skin care, exercise and compression bandage. Every component except compression bandage applied exacly the same to both group. Compression bandage applied with high bandage interface pressure (45-55 mmHg)
Other intervention name(s): Low bandage interface pressure; High bandage interface pressure
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised comparison trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: compelex decongestive physiotherapy; bandage interface pressure; compression therapy
Roflumilast Plus Antipsychotics Proof of Mechanism Study in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether cognitive impairment associated with
      schizophrenia is attenuated by add-on roflumilast administration to second generation
      antipsychotics (SGA) in participants with stable schizophrenia.
    

Detailed description: 
      The drug being tested in this study is called roflumilast. Roflumilast is being tested as an
      add-on treatment to second generation antipsychotics (SGA) to treat cognitive impairment in
      people with stable schizophrenia. This study will look at improvement in cognitive impairment
      associated with schizophrenia in people who take roflumilast as an add-on to SGA.

      The study will enroll approximately 22 participants. Participants will be randomly assigned
      (by chance, like flipping a coin) to one of three treatment groups-which will remain
      undisclosed to the patient and study doctor during the study (unless there is an urgent
      medical need) All participants will receive the following treatments at different periods
      throughout the study:

        -  Roflumilast Dose A + SGA

        -  Roflumilast Dose B +SGA

        -  Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has
           no active ingredient + SGA.

      All participants will be asked to take one tablet at the same time each day throughout the
      study.

      This single-centre trial will be conducted in the United Kingdom. The overall time to
      participate in this study is up to 64 days. Participants will make 2 screening visits to the
      clinic and then must be brought to the clinic every day for dosing during each of 3 Treatment
      Periods. Each Treatment Period will be 8 days in duration. All participants will also make 1
      final visit 14 days after last dose of study drug for a follow-up assessment.
    

Intervention name(s): Roflumilast; Placebo; Second generation antipsychotic
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Roflumilast tablets; Roflumilast placebo-matching tablets; Second Generation Antipsychotic (SGA) medication for standard of care therapy will be sourced and managed locally by the site.
Other intervention name(s): DALIRESP®; DAXAS®
Intervention MeSH terms: Antipsychotic Agents
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug therapy
Meningitis With Cerebral Vasculitis in Children
Condition: Bacterial Meningitis
MeSH terms: Meningitis, Bacterial; Meningitis; Vasculitis, Central Nervous System; Vasculitis
Study type: Observational

Summary: 
      Purulent meningitis are life-threatening diseases in childhood. Cerebral vasculitis have been
      described in bacterial meningitis, but poor is known about their physiology and their impact
      on outcome.

      The investigators decide to realize a retrospective mono-centric study carried out at
      Montpellier university hospital which looks back at a 7-year study(2009-2016).

      The Investigators selected purulent meningitis cases based on the bacteriological data
      provided by the HDB (hospital data base). The Investigators divides in two groups : Group A
      if patients present a cerebral vasculitis ( radiologic diagnostic by RMI or
      tomodensitometry), in all, cases the diagnosis of vasculitis was confirmed by a radiologist
      specialised in neuropaediatrics by a second reading;Group B purulent meningitis with a
      cerebral vasculitis imaging.

      Tuberculous meningitis, meningitis in CSF shunt, and in patients having chemotherapy were
      excluded.

      The investigators report clinical and biological finding, inflammatory marker at the onset.
      The Investigators register also the clinical evolution and sequelae
    

Detailed description: 
      Meningitis steel are a cause of death in childhood. Cerebral complication are often
      responsable of poor prognosis. One of these complication vasculitis is steel not weel
      understood. There are only few study about it on children.

      It is a retrospective study about 17 cases of chil which bacterial meningitis coupled wiethe
      cerebral vasculitis, the Investigators will describe epidemiology, bacteriology, evolution
      and corticosteroid treatment in this patients.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Children with bacterial meningitis, and cerrbal vasculitis
      
Keywords: cerebral vasculitis
Evaluation of Safety, Tolerability & Pharmacokinetics of JYP0061 in Healthy Adults.
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this clinical trial is to evaluate the safety, tolerability and pharmacokinetic
      characteristics of JYP0061 in healthy adult subjects. The main questions it aims to answer
      are: safety and tolerability of JYP0061 in healthy subjects, the pharmacokinetic
      characteristics after single and multiple doses and the effect of food on the pharmacokinetic
      characteristics. Participants will be treated with JYP0061 orally and safety and
      pharmacokinetic evaluations will be conducted according to the protocol.
    

Detailed description: 
      This study will be an double-blinded, single-center phase I clinical trial. After being
      informed about the study and potential risks, all subjects giving written informed consent
      will undergo a 2-week screening period to determine eligibility for study entry. And then
      subjects will be administered for single-dose treatment or 10-day multiple-dose treatment and
      5-day safety follow up after the last dose of treatment. The safety and pharmacokinetic
      measures will be conducted according to the protocol.
    

Intervention name(s): JYP0061; placebo
Intervention type(s): Drug; Drug
Intervention description(s): JYP0061 orally administered; Placebo orally administered
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Japanese Subjects
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Japan. The aim of this trial is to investigate the bioequivalence
      of two formulations of biphasic insulin aspart 50 (NN-X14Mix50) in healthy Japanese subjects.
    


Intervention name(s): biphasic insulin aspart 50
Intervention type(s): Drug
Intervention description(s): A single dose of each formulation administered subcutaneously (s.c., under the skin) on 2 dosing visits separated by a wash-out period of 6-21days
Intervention MeSH terms: Insulin Aspart; Biphasic Insulins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment