bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Evaluation of Approved and Investigational Contact Lenses
Condition: Visual Disorder
MeSH terms: Vision Disorders
Study type: Interventional

Summary: 
      This study is a multi-site, 5-visit dispensing, bilateral double-arm parallel group design,
      double-masked clinical trial using an investigational contact lens and a marketed contact
      lens. The objective is to evaluate comfort of the contact lenses when worn on a daily wear
      modality.
    


Intervention name(s): Investigational Contact Lenses (Test); Marketed Contact Lenses (Control)
Intervention type(s): Device; Device
Other intervention name(s): senofilcon C; comfilcon A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Quadratus Lumborum Block Versus Erector Spinae Block in Laparoscopic Cholecystectomy
Condition: Postoperative Analgesia
Study type: Interventional

Summary: 
      The patients were randomly allocated into 3 parallel groups of 20 patients in each group by
      using computer generated tables. group(Q):received bilateral sonar-guided quadratus lumborum
      bolck using 20 ml bupivacaine 0.25%on each side.group(E): received bilateral
      ultrasound-guided erector spinae block using 20 ml bupivaciane 0.25%on each side.
      group(C):didn't received any block
    

Detailed description: 
      on arrival to the operative room all patients were monitored with standared monitoring. then
      IV cannula were inserted. preoxygenation with 100% oxygen and induction of GA by 1mic/kg
      fentanyl and 2 mg/kg of 1%propofol. endotracheal intubation was facilitated by 0.5mg/kg of
      atracurium. isoflurane 1-2% with oxygen was used for anesthetic maintenance and 0.15 mg/kg
      intermittent doses of atracurium to maintain adequate muscle relaxation. ventilation was
      controlled to maintain end tidal CO2 at 35-40 mmHg and SaO2 between 95-100. after
      stabilization of the patient's hemodynamics and before surgical incision, quadratus lumborum
      and erector Spinae block were performed according to patient's group by the same anesthetist
      with the patient in lateral or prone position respectively.
    

Intervention name(s): nerve block
Intervention type(s): Procedure
Intervention description(s): bilateral ultrasound-guided posterior quadratus lumborum block was done in the lateral decubitus and linear or curvilinear probe was used according to the depth and placed in the midaxillary line in the transverse plane above the iliac crest
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Study to Determine How BCX4161 is Metabolized and Eliminated by the Body
Condition: Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the extent that radioactive dose of BCX4161 taken by
      mouth ends up in the urine, feces and expired air. If there are metabolites of BCX4161 made
      by the body, the chemical composition of these metabolites and their profile over time in
      blood and urine will be determined.
    


Intervention name(s): BCX4161
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BCX4161; BioCryst; hereditary angioedema; mass balance; kallikrein inhibitor; ADME
Post-Market Clinical-Follow-Up Study of Suprasorb® C Collagen Wound Dressing
Condition: Venous or Mixed Leg Ulcers
MeSH terms: Leg Ulcer
Study type: Observational

Summary: 
      Post-Market Clinical-Follow-Up Study of Suprasorb® C collagen wound dressing
    

Detailed description: 
      Prospective, uncontrolled multi-center, observational cohort study. The objectives of the
      PMCF study are confirmation of the performance, and to collect additional safety data
      regarding expected adverse events and to detect potential unexpected adverse events
      associated with use of Suprasorb®C under the conditions of routine use.

      Suprasorb® C collagen wound dressing is a certified medical device (manufacturer: Lohmann &
      Rauscher International GmbH & Co. KG). The product has been marketed in the EU since 1983 as
      Opragen® (medicinal product), since 1995 as the medical device Opraskin® and since 2001 under
      the name Suprasorb C (medical device).

      Suprasorb® C is intended to be used as a wound dressing for the support of wound healing or
      wound area reduction.

      Participating Centers: 40 study nurses will participate to the PMCF Study Duration: 24 months
      Cohort size: 110 patients Follow-up: 8 weeks
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The patient population is patient with venous or mixed leg ulcers
An Extension Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purposes of this study are to see if it is safe to use a new medication called
      vamorolone for more than two weeks in children with Duchenne muscular dystrophy (DMD), to see
      if vamorolone works for the treatment for DMD, and to see how any potential side effects
      compare to those seen in boys using steroids.
    

Detailed description: 
      This study will evaluate if it is safe to use a new medication called vamorolone for more
      than two weeks in children with DMD, if boys with DMD who take the study medication have
      improved muscle function compared to boys with DMD in other studies who did not take any type
      of steroid, and to see if boys with DMD who take the study medication gain less weight
      compared to boys with DMD in a prior study who took another type of steroid called
      prednisone. Enrolled participants will take the study medication for 24 weeks.
    

Intervention name(s): Vamorolone 0.25 mg/day/day; Vamorolone 0.75 mg/day/day; Vamorolone 2.0 mg/day/day; Vamorolone 6.0 mg/day/day
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral administration of 0.25 mg/kg/day daily for 24 weeks.; Oral administration of 0.75 mg/kg/day daily for 24 weeks.; Oral administration of 2.0 mg/kg/day daily for 24 weeks.; Oral administration of 6.0 mg/kg/day daily for 24 weeks.
Other intervention name(s): VBP15; VBP15; VBP15; VBP15
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Duchenne muscular dystrophy; vamorolone
Nitazoxanide for the Treatment of Prolonged Diarrhea in Children
Condition: Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to determine the efficacy of nitazoxanide suspension compared
      to placebo in treating prolonged diarrhea in children.
    


Intervention name(s): Nitazoxanide
Intervention type(s): Drug
Intervention description(s): Nitazoxanide Oral Suspension 100 mg/5 ml for patients aged 1-3 years twice daily for 3 days or Nitazoxanide Oral Suspension 200 mg/10 ml for patients aged 4-11 years twice daily for 3 days
Other intervention name(s): Alinia
Intervention MeSH terms: Nitazoxanide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diarrhea
Understanding the Differences in the Management of Patients With Arthritis of the Knee or Hip
Condition: Osteoarthritis; Arthritis, Degenerative; Osteoarthritis, Hip; Osteoarthritis, Knee
MeSH terms: Arthritis; Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip
Study type: Observational

Summary: 
      The purpose of this study is to examine cultural and clinical context factors in
      African-American and white veterans with knee or hip osteoarthritis with a focus on how these
      factors may be potentially modifiable determinants of willingness to consider joint
      replacement.
    

Detailed description: 
      The study focuses on identifying potentially modifiable determinants of patients� willingness
      to consider joint replacement as a treatment option for osteoarthritis of the knee or hip.
      This line of research is informed by not only our prior work but also recent studies on
      health disparities and patient decision-making. Our long-term goal is the development and
      evaluation of interventions to target these determinants of willingness in order to eliminate
      ethnic disparities in joint replacement. The study findings will assist in laying the
      groundwork for the design of such interventions for patients with osteoarthritis.
    

Keywords: Racial/ethnic health disparities; Attitudes; Osteoarthritis Management; Patient Perceptions
Effect of Aquatic Exercise Versus Aerobic Exercise on Primary Dysmenorrhea and Quality of Life in Adolescent Females
Condition: Dysmenorrhea Primary
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      This study was conducted to determine the difference between impact of aerobic and aquatic
      exercise on primary dysmenorrhea and quality of life in adolescent girls.
    

Detailed description: 
      Dysmenorrhea manifests as painful menstrual flow it occurs in two forms primary and
      secondary. Primary and secondary dysmenorrhea is painful menstruation occur without any
      gynecological disease it was conducted that prevalence of dysmenorrhea 74.6% and it was
      significantly more frequent in students from rural residence (Shaimaa et al., 2018).

      There is only one previous study investigate effect of aquatic exercise on primary
      dysmenorrhea (Rezvani et al., 2013). There are several previous studies investigate effect of
      aerobic ex , however non of the previous studies compared between effect of aerobic and
      aquatic exercise on primary dysmenorrhea and quality of life of adolescent girls .Therefore
      this study was the first one which aimed to investigate the difference between effect of
      aerobic and aquatic exercise on primary dysmenorrhea and quality of life in adolescent girls.
    

Intervention name(s): Aquatic Exercise; Aerobic Exercise
Intervention type(s): Other; Other
Intervention description(s): The aquatic exercises included 5 minutes of warming up in form of walking and running in water, 20 minutes of aerobic and strengthening exercises of pelvis, abdominal and thigh muscles (Double-leg Squat, lunge, knee flexion and extension, hip flexion and; The exercise protocol consists of 5 minute warm up, 35 min aerobic exercise and 5 minute cool-down. Exercises high-intensity treadmill-based treatment for primary dysmenorrhea for three days a week ,The Borg Rating of Perceived Exertion (RPE) Scale from 6 ('no exertion at all') to 20 ('maximal exertion') was used to regulate the exercise intensity on the treadmill. Participants were encouraged to increase the speed of the treadmill until they perceived their RPE to be between 14 and 16. or at a perceived exertion of 11.0 (Borg scale) for the first five minutes (warm-up period), followed by aerobic exercise at 70-85% of maximum heart rate (MHR) (16.0-18.0 Borg scale) for 30 minutes. At the end of the exercise session, women completed a 5-minute cool-down (11.0 Borg scale).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Primary Dysmenorrhea; Adolescent Females; Aquatic Exercise; Aerobic Exercise; Pressure Pain Threshold; Quality of Life
Efficacy of Ear Neurostimulation for Adolescents With Functional Abdominal Pain
Condition: Functional Disorder of Intestine; Nausea Persistent
MeSH terms: Intestinal Diseases
Study type: Interventional

Summary: 
      This study evaluates the effectiveness of a neurostimulator applied to the outer ear for
      adolescents with functional gastrointestinal disorders. The neurostimulator provides nerve
      stimulation to a branch of the vagus nerve which is thought to be involved in transmission of
      pain signals. Half of the study subjects will receive an active nerve stimulator while the
      other half will receive an inactive one.
    

Detailed description: 
      The vagus nerve innervates the gastrointestinal tract and influences the autonomic nervous
      system. It is thought to carry signals of discomfort and nausea to the brain where it is
      interpreted. The autonomic nervous system may be in imbalance in patients with functional
      gastrointestinal disorders. By stimulating a branch of the vagus nerve in the outer ear, this
      study aims to improve symptoms and quality of life in adolescents with functional abdominal
      pain with or without nausea.

      Subjects will be randomized into two groups: 1) neurostimulation versus 2) sham. They will
      receive either an active or non-active (sham group) device for 5 days each week x 4 weeks
      total. Pain, nausea, anxiety, quality of life, potential side effects and overall symptom
      improvement will be monitored weekly for the entire study as well as after the study is
      completed.
    

Intervention name(s): Neurostimulator; Sham
Intervention type(s): Device; Device
Intervention description(s): Non-invasive, battery operated neurostimulator of the external ear worn for 5 days each week x 4 weeks.; Inactive neurostimulator device pre-programmed to be inactive. To be worn for 5 days each week x 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Drug Interaction Between SHR4640 Tablets and Furosemide Tablets in Healthy Volunteers (Single Center, Single Arm, Open, Self-control)
Condition: Healthy Male Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to evaluate the effect of SHR4640 tablets on the
      pharmacokinetics of furosemide tablets in healthy male volunteers, using a single-center,
      single-arm, open, self-control design.
    


Intervention name(s): SHR4640 tablets and furosemide tablets
Intervention type(s): Drug
Intervention description(s): SHR4640 tablets and furosemide tablets
Intervention MeSH terms: Furosemide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Evaluate the Bioequivalence of Tocilizumab Following Subcutaneous Administration Via an Autoinjector (AI 1000-G2) Versus a Pre-Filled Syringe in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The study consists of an eligibility screening period, two study periods involving single
      doses of tocilizumab (TCZ) according to an open-label, randomized, two-period crossover
      design with an interval of 6 weeks between periods, and a 6 week follow-up period. Healthy
      participants will receive a single subcutaneous (SC) injection of TCZ via a pre-filled
      syringe-needle safety device (PFS-NSD) and a single injection via an autoinjector (AI). The
      total duration of the study is up to 16 weeks from screening to follow-up. After screening,
      eligible participants will be randomly assigned to one of the two possible treatment
      sequences (Sequence 1: AI-1000 G2 followed by PFS-NSD or Sequence 2: PFS-NSD followed by
      AI-1000 G2) and assigned to one of three injection sites (1: abdomen, 2: thigh, or 3: upper
      arm). All participant groups will receive a total of two TCZ administrations each.
    


Intervention name(s): AI-1000 G2; PFS-NSD; Tocilizumab
Intervention type(s): Device; Device; Drug
Intervention description(s): The device will contain TCZ (180 milligrams per milliliter [mg/mL]) SC formulation single dose of 0.9 mL that corresponds to 162 mg TCZ administered via PFS and assembled in the AI (AI-1000 G2).; The device will contain TCZ (180 mg/mL) SC formulation single dose of 0.9 mL that corresponds to 162 mg TCZ administered via PFS-NSD.; Participants will receive two single doses of 162 mg tocilizumab SC on Day 1 (Period 1) and Day 43 (Period 2), with a washout period of 6 weeks between the periods.
Other intervention name(s): RO4877533; Actemra/RoActemra
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Drug Intervention in Chronic Fatigue Syndrome
Condition: Chronic Fatigue Syndrome
MeSH terms: Fatigue Syndrome, Chronic; Syndrome; Fatigue
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Based on pilot patient observations,the investigators anticipate that chronic fatigue
      syndrome (CFS) patients may benefit from B-cell depletion therapy.

      The hypothesis is that at least a subset of CFS patients have an activated immune system
      involving B-lymphocytes, and that B-cell depletion may alleviate symptoms.
    


Intervention name(s): Rituximab; Saline (NaCl 0,9 %) (placebo)
Intervention type(s): Drug; Drug
Intervention description(s): Two infusions of Rituximab 500 mg/m2 (max 1000 mg) given two weeks apart; Two infusions of saline (NaCl 0,9 %) given two weeks apart
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Fatigue Syndrome; CFS; Myalgic Encephalomyelitis; Rituximab; B-lymphocyte depletion; B-cell depletion
A Phase I Study of AZD4635 in Japanese Patients With Advanced Solid Malignancies
Condition: Advanced Solid Malignancies
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, open-label study to assess the safety, tolerability, pharmacokinetics and
      anti-tumor activity of AZD4635 in Japanese patients with advanced solid malignancies. This
      study consists of 2 cohorts, Cohort1 and Cohort2. At least 3 or up to 6 evaluable Japanese
      patients with advanced solid malignancies will be enrolled in Cohort1 and 6 evaluable
      patients will be enrolled in Cohort2.
    

Detailed description: 
      Objectives:

      Primary objective:

      Investigate the safety and tolerability of AZD4635 monotherapy in Japanese patients

      Secondary objective:

      Characterize the single-dose and multiple-dose plasma pharmacokinetic (PK) parameters of
      AZD4635 monotherapy Determine the preliminary anti-tumor activity of AZD4645 monotherapy

      Overall design:

      This is a phase I, open-label study of AZD4635 in Japanese patients with advanced solid
      malignancies.

      The study consists of 2 cohorts, Cohort 1 and Cohort 2. At least 3 or up to 6 evaluable
      Japanese subjects with advanced solid malignancies will be enrolled in Cohort 1 and 6
      evaluable patients will be required for Cohort 2 to confirm the tolerability. The total
      number of evaluable subjects in each cohort will depend upon available data in each cohort
      and decision of Safety Review Committee(SRC).

      Study Period:

      The study is expected to start in June 2019 and end in June 2020.

      Number of Subjects:

      9 to 12 evaluable subjects will be enrolled in this study to confirm the tolerability.

      Treatments and treatment duration:

      Subjects will receive AZD4635 once daily (QD). A single dose of AZD4635 will be taken on
      Cycle 0 Day1 and the subsequent dose of AZD4635 will be taken from Cycle 1 Day 1 until
      discontinuation criterion is met. A cycle of study treatment will be defined as 21 days of
      continuous dosing.
    

Intervention name(s): AZD4635
Intervention type(s): Drug
Intervention description(s): AZD4635 taken orally
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Anesthetic Advantages of Dexmedetomidine for Hypotensive Anesthesia
Condition: Anesthesia; Hypotension
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the positive anesthetic properties such as reduce
      intraoperative analgesic requirement, time to extubation and recovery, and early
      postoperative pain of dexmedetomidine used as a hypotensive agent compared with
      nitroglycerin.
    

Detailed description: 
      The subject included the healthy patients who underwent orthognathic surgery and gave written
      the informed consent. The sample size was calculate from the amount of fentanyl use in
      orthognathic surgical case and difference more 30% was significant. Randomization was done by
      random number table to 2 groups. Both groups received standardized controlled hypotensive
      anesthesia and surgery. D group used dexmedetomidine as the hypotensive drug and N group use
      nitroglycerin. The main outcome were the amount of fentanyl use, time to eye opening, follow
      simple command, extubation, early postoperative pain, and early postoperative amount of pain
      killer. All recorded by anesthesiologist on data sheet.

      compare statistical analysis used compare mean by unpaired student t test.
    

Intervention name(s): Dexmedetomidine; Nitroglycerin
Intervention type(s): Drug; Drug
Intervention description(s): controlled hypotensive anesthesia with dexmedetomidine compare with nitroglycerin on anesthetic outcome such as analgesic use, time to eye opening, follow verbal command, extubation and early postoperative pain; controlled hypotensive anesthesia with nitroglycerin compared with dexmedetomidine on anesthetic outcomes such as analgesic use, time to eye opening, follow verbal command, extubation, and early postoperative pain.
Other intervention name(s): precedex; nitrocine
Intervention MeSH terms: Nitroglycerin; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: dexmedetomidine; controlled hypotensive anesthesia