bioihbjkbjnl/mcl2 huggingface dataset:
Immunisation, Treatment and Controlled Human Hookworm Infection
Condition: Necator Americanus Infection
MeSH terms: Infections; Communicable Diseases; Hookworm Infections; Ancylostomiasis
Study type: Interventional

Summary: 
      24 healthy volunteers will be immunized with three times 50 L3 larvae or placebo followed by
      treatment with albendazol and subsequently challenged with twice 50 L3 larvae.
    

Detailed description: 
      24 healthy hookworm-naive volunteers will be randomized in a 2:1 allocation to either the
      intervention group or placebo. Volunteers in the intervention group will be immunized three
      times with 50 L3 larvae of Necator americanus with three-week intervals. Two weeks after each
      immunization, volunteers will be treated with albendazole. Four weeks after the last
      treatment all volunteers are challenged with controlled human hookworm infection consisting
      of two doses of 50 L3 larvae with a two week interval. 16 weeks after the first challenge all
      volunteers will be treated with albendazole, except up to four volunteers who will be asked
      to remain as chronic donors for future hookworm studies.
    

Intervention name(s): 3x 50 L3 larvae immunisation with albendazole treatment; 3x placebo immunisation with albendazole treatment; 2x 50 L3 larvae infection
Intervention type(s): Biological; Other; Biological
Intervention description(s): Immunisation with 50 Necator americanus L3 larvae at week 0, 3 and 6 with albendazole treatment at week 2, 5 and 8; Mock immunisation with water at week 0, 3 and 6 with albendazole treatment at week 2, 5 and 8; After (mock) immunisation, infection with 50 Necator americanus larvae at week 13 and 15
Intervention MeSH terms: Albendazole
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Volunteers are randomized into either the intervention or the placebo group (2:1 allocation). The two groups run parallel in the trial. At the moments of immunization in the intervention group volunteers in the placebo group receive a mock infection with water to maintain blinding.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
IMPULSE: A Safety and Feasibility Study of the IOWA Approach Endocardial Ablation System to Treat Atrial Fibrillation
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      IMPULSE is a prospective, single-arm, multi-center, safety and feasibility study evaluating
      the IOWA Approach Endocardial Ablation System (FARAPULSE, Inc.) for the treatment of
      paroxysmal atrial fibrillation.
    

Detailed description: 
      Patients undergoing catheter ablation for paroxysmal atrial fibrillation will be screened for
      enrollment per protocol inclusion and exclusion criteria. Enrolled patients will then undergo
      ablation using the IOWA Approach Endocardial Ablation System (FARAPULSE, Inc.). Subjects will
      be followed at 7 days, 30 days, 3 months, 6 months and 12 months with a blanking period for
      recurrent atrial fibrillation or atrial tachycardia of 3 months following the PEF catheter
      ablation procedure.
    

Intervention name(s): IOWA Approach Endocardial Ablation System
Intervention type(s): Device
Intervention description(s): Endocardial ablation using the IOWA Approach Endocardial Ablation System
Intervention model: Single Group Assignment
Intervention model description: Patients undergoing catheter ablation of paroxysmal atrial fibrillation and meeting all protocol inclusion/exclusion criteria will be treated with the IOWA Approach Endocardial Ablation System.
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Single Versus Repeat Doses of AM-101 in the Treatment of Acute Inner Ear Tinnitus
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the therapeutic benefit and safety of intratympanic
      AM-101 injections in comparison to placebo in the treatment of persistent acute inner ear
      tinnitus.
    


Intervention name(s): AM-101 0.81 mg/mL; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
An Efficacy and Safety Study of Itraconazole Sequential Therapy (Intravenous Injection Followed by Oral Solution) in Invasive Pulmonary Fungal Infections
Condition: Pulmonary Fungal Infection
MeSH terms: Infections; Communicable Diseases; Mycoses; Lung Diseases, Fungal
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of itraconazole sequential
      therapy (intravenous injection/oral solution) in participants with invasive pulmonary fungal
      infections ([IPFI]; lung diseases caused by fungal infection).
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), single arm,
      multicenter (when more than one hospital or medical school team work on a medical research
      study) study to evaluate the efficacy and safety of itraconazole sequential therapy in
      participants with IPFI. The study duration will be 4 to 6 weeks. The treatment will be
      divided into the intravenous (into a vein) injection period and the oral solution
      administration (giving) period. During the intravenous injection period 200 milligram (mg)
      twice daily loading dose (large initial dose) will be given for first 2 days, 200 mg once
      daily for the subsequent 12 days. Then sequential itraconazole oral solution 200 mg twice
      daily will be given as maintenance therapy (treatment designed to help the original primary
      treatment to succeed) for 2-4 weeks. Participant's clinical, mycological and comprehensive
      efficacy will be assessed at Week 6. Participants' safety will be monitored throughout the
      study.
    

Intervention name(s): Itraconazole
Intervention type(s): Drug
Intervention description(s): Itraconazole 200 milligram (mg) intravenous injection will be given twice daily for first 2 days, 200 mg once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily will be given for 2 to 4 weeks.
Intervention MeSH terms: Itraconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Invasive Pulmonary Fungal Infection; Itraconazole
EFFICACY OF AN EXERCISE PROPRIOCEPTIVE PROGRAM IN INSTITUTIONALIZED ELDERLY
Condition: Accidental Falls
Study type: Interventional

Summary: 
      Knowing the effects of proprioceptive exercise program in improving balance, gait and risk of
      falls in institutionalized elderly.
    

Detailed description: 
      The aim of this study will be to determine the effects of proprioceptive exercise program in
      improving balance and gait as well as reducing the risk of falls in institutionalized elderly
      in a healthcare center. To evaluate this effect, a total of 45 subjects will participate in a
      longitudinal and controlled trial. Inclusion criteria will be over 65 years olds, be
      institutionalized in the center and have ability to read and write.

      Thereafter, participants will be separated into two different groups (experimental and
      control). Randomization was performed using sealed envelopes with different numbers of
      intervention inside. Both groups will be evaluated both at the start of the first session and
      in the last working session.

      The control group performed a geriatric revitalization program as the experimental group.
      Besides this one, experimental group performed a program of proprioceptive exercises. The
      intervention rate will 2 weekly sessions for 12 weeks for both groups (24 sessions), lasting
      55 minutes. The variables analyzed were: the questionnaire risk of falls in hospital (MORSE),
      Tinetti scale, the test Timed Up and Go (TUG), the time of one leg and the Cooper test
      running 12 minutes.

      The data analysis will perform using the Statistical Package for the Social Sciences (SPSS
      statistical software), version 19.0 for Windows, Chicago.

      To determine the normal distribution of the data the Shapiro-Wilks test and comparison by
      ANOVA was performed. The values obtained in the pretest and posttest assessment for each
      variable will be compared by Student t test for related samples or by the Wilcoxon rank test.
    

Intervention name(s): propioceptive program; No propioceptive program
Intervention type(s): Other; Other
Intervention description(s): The training program has 6 specific proprioceptive exercises, each five minutes long, which will conducted in static and dynamic positions for a period of 30 minutes. Each exercise session will include 55 minutes (15 minutes of warm-up with slow walk, mobility and stretching exercise, followed by 30 minutes of a propioceptive exercises program, and finishing with 10 minutes of cool down through stretching and relaxation exercises); The control group continued to perform their daily activities without changing any habit. Geriatric revitalization program without proprioceptive exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: falls prevention; proprioception; physical condition
Acceptability and GI Tolerance of an Alpha-lactalbumin-enriched Formula
Condition: Infant Formula Intolerance
Study type: Interventional

Summary: 
      A single center, non-controlled trial to document the gastrointestinal (GI) tolerability of
      the study formula (SF), containing a whey protein concentrate enriched with alpha-lactalbumin
      (WPC alpha-lac) fed for 6 weeks to healthy, term infants.
    

Detailed description: 
      The purpose of this study is to examine the tolerable and acceptability of an infant formula
      with with a Whey protein concentrate containing alpha-lactalbumin as measure by GI tolerance,
      and eating behaviors.
    

Intervention name(s): S-26 Gold
Intervention type(s): Other
Intervention description(s): A commercial whey protein dominant, first age formula, containing whey protein concentrate with alpha-lactalbumin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: infant formula
Coconut Sugar Lowers Blood Pressure and Arterial Stiffness in Middle-aged and Older Adults
Condition: Aging; Blood Pressure; Arterial Stiffness
Study type: Interventional

Summary: 
      The goal of this intervention is to determine the efficacy of coconut sap powder (CSP) to
      lower arterial stiffness and blood pressure in middle-aged and older adults. Participants
      will be randomized to the CSP arm or Placebo arm of the study. Primary endpoints include:
      aortic stiffness assessed by carotid-femoral pulse wave velocity, resting brachial and
      (non-invasive) carotid blood pressure, and carotid stiffness (e.g. Beta stiffness index,
      Carotid compliance, Elastic modulus, Distensibility).
    


Intervention name(s): Coconut Sap Powder (CSP); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): CSP was given once daily (1.5 g/day) for 8 weeks.; Capsules containing aspartame (1.5 g/day) were taken orally once daily for 8 weeks.
Other intervention name(s): COCOZEN; Coconut Inflorescence Sap
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Validity of Neurocognitive Assessment Methods in Childhood ADHD
Condition: Neurodevelopmental Disorders; Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity; Neurodevelopmental Disorders
Study type: Observational

Summary: 
      The aim of the study is to examine the prospective validity of neurocognitive functions and
      emotional factors in schoolchildren with ADHD and a control group of typically developing
      schoolchildren at baseline and after three years.
    

Detailed description: 
      In spite of extensive research on children with ADHD, there is still insufficient
      understanding of the discriminative validity of neurocognitive tests and how test results of
      neurocognitive functions and ratings of emotional factors and ADHD symptoms change over time
      and interacts during development. The project is studying the validity of clinical assessment
      methods within the Swedish child and adolescent psychiatry service (CAP) related to the
      identification of ADHD, additional impairments, and comorbidity. The prospective validity of
      neurocognitive functions and emotional factors in schoolchildren with ADHD and a control
      group of typically developing schoolchildren at baseline and after three years will be
      investigated.

      Specific aims: Aim I: Study how attentiveness and impulsivity in ADHD change over three years
      by comparing the results of psychological tests and rating scales at baseline and after three
      years Aim II: Study intellectual development in ADHD by comparing the results of intelligence
      tests at baseline and after three years- Aim III: Study how emotional factors change over
      three years by comparing the results of rating scales at baseline and after three years
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children diagnosed with ADHD at the Neuropsychiatric Unit of the CAP Clinic in Lund in
        2011-2012, 7 to 18 years old when recrutited to the study. School children from Lund, 7 to
        18 years old when recrutited to the study.
      
Keywords: Intelligence; Anxiety; Attention; Conduct behavior; Follow-up; Children
Nefopam and Morphine Consumption in the Treatment of Ureteral Calculi
Condition: Ureteral Calculi, Hyperalgic, Not Complicated
MeSH terms: Ureteral Calculi; Ureterolithiasis; Calculi
Study type: Interventional
Phase: Phase 4

Summary: 
      The administration of néfopam after initial treatment by kétoproféne, could obtain, in
      patients remaining pain and classically need morphine, analgesia at least the same as
      morphine alone. The use of néfopam second line after ketoprofen could reducing (or even
      eliminating) the need for morphine (and its side effects), allowing a reduction in the length
      of stay of patients in the emergency unit.

      The main objective is to show that the addition of a néfopam initial treatment with the
      kétoproféne, reduces, in patients with ureteral calculi, the percentage of patients requiring
      the use of a treatment by morphine.

      The secondary objective is to reduce the side effects caused by the morphine, shorten the
      time to install the appropriate level of analgesia while reducing the risk of failure of the
      titration morphine, reduce the time spent on titration of morphine and reduce the length of
      stay patient intake in emergency unit.
    

Detailed description: 
      The study is prospective, parallel, double-blind, randomized, placebo-controlled analysis
      with intent to treat. There are 2 groups:

        -  A group N: néfopam

        -  A group P: placebo And all the patient receive, before randomization, 100 mg of
           ketoprofen (Profenid ®) on 20 minutes.

      The number of subjects is 52.
    

Intervention name(s): Néfopam
Intervention type(s): Drug
Intervention description(s): There are two groups :
a group N : néfopam
a group P : placebo All the patients receive, before randomization, 100 mg of ketoprofen (Profenid) on 20 minutes.
Intervention MeSH terms: Nefopam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pain, morphine, nefopam, co analgesia, ureteral calculi, emergency
Manual Therapy on the Improvement of Functional Disability in Patients With Chronic Non Specific Low Back Pain
Condition: Back Pain Lower Back Chronic
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Background: Models have tried to explain the driving mechanisms behind chronic non specific
      low back pain (CNSLBP) in order to propose better appropriate conservative treatment. Altered
      responses at spinal and/or supraspinal level may affect the perception of pain and degree of
      disability of CNSLBP patients. Recent clinical recommendations still propose active exercises
      (AE) for CNSLBP. However, acceptance of exercises by patients may be limited by pain-related
      manifestations. Current evidences suggest manual therapy (MT) induces a short-term analgesic
      effect through neurophysiological mechanisms at peripheral, spinal and cortical levels. The
      aim of this study was first, to assess whether MT has an instant analgesic effect, and
      second, to compare the long-lasting effect on functional disability of MT followed by AE to
      sham therapy (ST) followed by AE. Methods: Forty-two CNSLBP patients without co-morbidities,
      randomly distributed into 2 treatment groups, received either spinal
      manipulation/mobilization (first intervention) plus AE (MT group; n = 22), or detuned
      ultrasound (first intervention) plus AE (ST group; n = 20). Eight therapeutic sessions were
      delivered over 4 to 8 weeks. Instant analgesic effect was obtained by measuring pain
      intensity (Visual Analogue Scale) before and immediately after the first intervention of each
      therapeutic session. Pain intensity, disability (Oswestry Disability Index) and
      fear-avoidance beliefs (Fear-Avoidance Beliefs Questionnaire) were determined before
      treatment, after the 8th therapeutic session, and at 3- and 6-month follow-ups.
    


Intervention name(s): Manual therapy and active exercises; Detuned ultrasound and active exercises
Intervention type(s): Procedure; Procedure
Intervention description(s): Spinal manipulation/mobilisation (5-10 minutes), consisting of passive accessory intervertebral movements, muscle-energy techniques and high velocity, low amplitude dynamic thrust.
Active exercises (20 minutes), consisting of mobility, stretching, strengthening and motor control exercises; Electrotherapy device inactivated and ineffective. Active exercises, consisting of mobility, stretching, strengthening and motor control exercises
Other intervention name(s): Spinal mobilisation; Manipulation; Electrotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic non specific low back pain; Manual therapy; Active exercises; Pain; Disability
Effect of Body Suspension and Tilting Exercises in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      This study evaluates the effect of body suspension and tilting exercises (performed in
      Chordata apparatus) on the balance and mobility of subjects with Parkinson disease. Half of
      patients will perform the exercise protocol while the other half will receive passive muscle
      stretching and maintain the usual routine.
    

Detailed description: 
      Body suspension and tilting exercises performed in the Chordata equipment might be an
      effective option to improve trunk muscles activation and to facilitate functional balance and
      mobility control in Parkinson's disease (PD). To evaluate this hypothesis, subjects will be
      randomized into control group or intervention group. Intervention group will receive
      30-minute session of body suspension and tilting exercises on the Chordata equipment (PI:
      0804871-1 and BR 10 2012 009901-2) twice a week for eight weeks, while the control group will
      receive passive muscle stretching and maintained their usual routine during the same period.
      Both groups will be assessed at baseline and immediately after the intervention protocol.
      Finally, a follow-up evaluation will be performed 8 weeks after the protocol ending (to
      verify possible long-lasting effects of this exercise protocol).
    

Intervention name(s): Intervention group (Body body suspension and tilting exercises); Control group (global muscle stretching)
Intervention type(s): Other; Other
Intervention description(s): The body suspension and tilting exercise program (Chordata Method) involved suspending the body in the apparatus while performing tilting exercises. The Chordata apparatus consists of a steel structure with special springs and a harness specifically manufactured for practicing the Chordata Method. During the training sessions, the prescribed exercises emphasize the repetition of movements designed to promote different types of muscle contractions (concentric, eccentric, static) performed in different body positions and joint angles. Thus, when using the method, patients experience maximal functional performance beyond to the body mass centre, activating trunk antagonist muscles and motor memory evocation. Each session lasts 30 minutes.; Subjects receiving submitted a global muscle stretching session twice a week for eight weeks. During this period. All participants are requested to don't engage in any additional type of exercise program or physical activity throughout the study period.
Other intervention name(s): Chordata body suspension and tilting; Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Balance; Mobility; Trunk control