bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Cervical Traction on Balance in Cervical Radiculopathy Patients
Condition: Cervical Radiculopathy; Vertigo
MeSH terms: Vertigo; Radiculopathy
Study type: Interventional

Summary: 
      A cross-over randomized trial aiming to assess the immediate effect of cervical traction on
      balance disorders among patients with common cervical neuropathy. Authors hypothesized that
      as cervical traction alleviate radicular pain it may also improve patient balance disorders.
      Effective traction is compared to sham traction.

      Main outcome measures are balance parameters (force platform).
    

Detailed description: 
      A cross-over randomized trial was designed to assess the immediate effect of cervical
      intermittent traction on balance disorders among patients diagnosed with common cervical
      neuropathy. The diagnosis is confirmed or made by a physical medicine and rehabilitation
      physician with 15 Y of experience treating musculoskeletal disorders especially cervical
      neuropathy. Enrolled patients are randomly assigned to one of two arms (1 or 2). Patients in
      arm 1 (Effective Traction/Sham Traction) are treated firstly with effective traction than one
      week later with sham traction. Patients in arm 2 (Sham Traction/Effective Traction) are
      treated firstly with sham traction than one week later with effective traction. At baseline
      the epidemiological parameters, the pain intensity (VAS), the grip strength, the functional
      status (NDI), the psychological distress (HAD), the Brief Best Test and the balance
      parameters (force platform) are assessed. The pain intensity, the grip strength and the
      balance parameters are assessed before and immediately after cervical traction for
      comparison.
    

Intervention name(s): Cervical Traction Device
Intervention type(s): Device
Intervention description(s): While The patient is lie on the back his or her head is housed within the specific head portion of the device. The investigator inflate progressively the device using a valve and ensuring the patient's relaxation. The process of inflation is continued until the level of 12 Kg of pressure is reached. This maximum level of traction is maintained for 10 minutes then the process of deflation is started until the pressure decreased to 0 Kg. This maneuver is reproduced once again after 5 minutes of rest.
The balance assessment using the force plate-from is done just before the intervention and 5 minutes after its end.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Two interventions: Effective Traction (ET) and Sham Traction (ST) Two arms: Arm 1: Effective Traction/Sham Traction (ET than ST) and Arm 2: Sham Traction/Effective Traction (ST than ET) Wash out period = 1 week
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cervical Radiculopathy; Vertigo; Traction; Balance Postural
A Pilot Study to Assess the Safety Profile of resB®
Condition: Healthy; Asthma
Study type: Interventional

Summary: 
      The study investigates the safety and tolerability of 4-week, twice daily supplementation of
      resB® Lung Support in asthma patients and healthy participants.
    

Detailed description: 
      resB® Lung Support is a probiotic dietary supplement that contains 3 probiotic strains and 3
      herbal extracts: turmeric, holy basil, and vasaka. The proprietary herbal and probiotic blend
      is formulated to support proper lung structure and function. The study investigates the
      safety and tolerability of twice-daily supplementation of resB® Lung Support in asthma
      patients and healthy participants for 4 weeks.
    

Intervention name(s): Probiotic Dietary Supplement
Intervention type(s): Dietary Supplement
Intervention description(s): Probiotic dietary supplement containing 3 probiotic strains and 3 herbal extracts
Other intervention name(s): resB® Lung Support
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Effects of E2609 on QTc Interval in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This thorough QT (TQT) study will take place in healthy subjects administered single doses of
      study drug. It will be a randomized, double-blind, placebo and active-controlled, 4-treatment
      crossover study. Subjects will be randomized in an equal ratio to one of 12 possible
      treatment sequences. Each treatment sequence will comprise all 4 treatments.
    

Detailed description: 
      The study will consist of 2 phases: Prerandomization and Randomization. The Prerandomization
      Phase will have 2 periods: Screening (up to 27 days) and Baseline Period 1 (1 day).
      Eligibility will be determined during the Screening Period. The Randomization Phase will
      consist of 8 periods: Treatment Period 1, Baseline Period 2, Treatment Period 2, Baseline
      Period 3, Treatment Period 3, Baseline Period 4, Treatment Period 4, and a Follow-Up Period.
      Each Baseline Period will last 1 day, followed by the corresponding treatment period. On the
      first day of each treatment period, subjects will receive a single dose of the assigned study
      drug. During each treatment period, subjects will be required to stay in the clinical unit
      from the baseline period to 24 hours postdose. Subjects will then be released from the clinic
      and will undergo a washout interval of at least 13 days, during which time they will return
      for additional PK sampling.
    

Intervention name(s): Placebo; E2609; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 8 placebo tablets matching E2609; E2609 will be administered as 8 tablets; Administered as 1 tablet with 7 tablets of placebo matching E2609
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: QTc Interval; Healthy Subjects
Renal Sympathectomy in Treatment Resistant Essential Hypertension, a Sham Controlled Randomized Trial
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional

Summary: 
      The purpose of this double blind, randomized and sham controlled study is to determine
      whether renal denervation in terms of catheter based ablation in the renal arteries is
      effective in lowering blood pressure in patients with treatment resistant hypertension. The
      blood pressure lowering effect will be evaluated by 24 hours ambulatory blood pressure
      measurement at baseline and after 1, 3 and 6 months of follow up. Secondary end point
      evaluation concerns hemodynamic measures using echocardiography, applanation tonometry and
      forearm plethysmography.
    


Intervention name(s): Renal artery ablation; Renal angiography
Intervention type(s): Procedure; Procedure
Intervention description(s): Catheter based renal denervation by applying low power radiofrequency to the renal artery using the Ardian Medtronic Simplicity Catheter, introduced by femoral artery access.; Renal angiography by femoral access.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Treatment Resistant Hypertension
Evaluation of [18F]MPPF as a Brain Tracer of Serotonin Receptor 5HT1a
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The underlying goal of this study is to assess [18F]MPPF PET imaging as a tool to evaluate
      the activity of the serotonin 5HT1a receptor in the brain of Parkinson Disease (PD) research
      participants.
    

Detailed description: 
      Approximately 40 subjects with Parkinson disease and 20 healthy control subjects will be
      recruited to participate in the 2 Projects in this study. All subjects will undergo written
      informed consent and a screening evaluation including baseline clinical laboratory testing, a
      baseline physical and neurological evaluation and baseline cognitive evaluations.

      Subjects in Project 1 (20 PD and 20 HC subjects) will be asked to undergo a single bolus
      injection of [18F]MPPF followed by serial Positron Emission Tomography (PET) imaging scans
      and blood sampling for measurement of [18F]MPPF in plasma (both protein bound and free) over
      a period of up to 2 hours. The imaging analyses will be performed by an image-processing
      specialist who will remain masked to the procedures employed with each imaging acquisition.
      The primary imaging outcome measure will be the brain regional distribution volumes expressed
      as a brain tissue to plasma ratio of the radioligand, [18F]MPPF. Time to the peak uptake and
      amplitude of the peak uptake will be evaluated for all brain regions and the results for the
      PD subjects will be compared with the HC subjects.

      Subjects participating in Project 2 (20 PD subjects on dopaminergic replacement therapy) will
      also undergo a second [18F]MPPF and PET imaging session, identical except that PD medications
      will be withheld for approximately 8 hours prior to the imaging session. The second session
      will occur greater than 7 days, but not more than 3 months, from the first imaging session.
      Initial 'on' medication quantitative outcomes for each brain region will be compared to the
      outcomes from the second 'off' medication imaging session to determine the influence of
      dopaminergic treatment on 5HT1A activity.

      The primary imaging outcome measure will be the brain regional distribution volumes expressed
      as a brain tissue to plasma ratio of the radioligand, [18F]MPPF. Time to the peak uptake and
      amplitude of the peak uptake will be evaluated for all brain regions and the results for the
      PD subjects will be compared with the HC subjects.
    

Intervention name(s): [18F]MPPF
Intervention type(s): Drug
Intervention description(s): Subjects will be dosed by intravenous bolus injection of [18F]MPPF targeted to be 5.0 mCi, and not to exceed 5.5 mCi (not >10% of 5.0 mCi limit) and not to exceed 5 µg of MPPF
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Parkinson Disease; [18F]MPPF
PainSquad+: A Smartphone App to Support Real-time Pain Management for Adolescents With Cancer
Condition: Therapy-Associated Cancer
MeSH terms: Neoplasms, Second Primary
Study type: Observational

Summary: 
      Adolescents with cancer (AWC) are in a unique developmental stage that may mean pain
      characteristics, the impact of pain, and pain treatment outcomes are different in adolescents
      compared to children and adults. In response, we will develop and test the PainSquad+ pain
      management smartphone app. First, we will conduct usability testing to refine PainSquad+ so
      that it is useable, acceptable and understandable for AWC. Secondly we will: (a) test the
      feasibility of conducting a large-scale PainSquad+ experiment and (b) begin to examine how
      effective PainSquad+ is at helping adolescents manage pain. We hope that once developed and
      tested for effectiveness, PainSquad+ will improve pain treatment and ultimately quality of
      life in AWC.
    

Detailed description: 
      Using a conservative estimate of 7 adolescents per cycle and 3 testing cycles, 21 adolescents
      will take part in usability testing of the PainSquad+ prototype. Recruitment will be
      conducted in a single hematology/oncology division of a metropolitan and
      university-affiliated pediatric tertiary care center in Toronto, Canada. This site hosts one
      of the largest cancer programs in North America, with approximately 350 new diagnoses each
      year. Based on our previous research at this site, 72 ± 4% (M ± SD; range = 67-75%) of
      eligible AWC agreed to participate in similar studies (unpublished data). Convenience
      sampling will be used to recruit eligible individuals. The testing procedures will commence
      after eligibility is assessed, informed consent is obtained, and demographic and baseline
      outcome data are collected. Inclusion criteria will be: (a) aged 12-18 years, (b) able to
      speak and read English, (c) actively undergoing cancer treatment on an in- or out-patient
      basis, (d) being at least 3 months from diagnosis and (d) having self-reported pain of any
      intensity in the week immediately prior to recruitment. Exclusion criteria will be: (a) one
      or more major co-morbid (medical or psychiatric) conditions that would preclude use of a
      smartphone, and (b) palliative/end-of-life patients.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adolescents aged 12-18 years who have been diagnosed at least 2 months with cancer and have
        had pain in the past week.
Phase 2 Study of Velusetrag in Diabetic or Idiopathic Gastroparesis
Condition: Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, randomized, double-blind, incomplete block, three period fixed
      sequence crossover, multicenter, placebo-controlled study. The study will assess three oral
      doses of velusetrag (5 mg, 15 mg, and/or 30 mg) or placebo, administered once daily in three
      periods of 1-week duration each, with a 1-week washout period between treatment periods, in
      subjects with diabetic or idiopathic gastroparesis.

      Study 0093 will evaluate the effect of velusetrag in subjects with diabetic or idiopathic
      gastroparesis by assessing changes in gastric emptying.
    


Intervention name(s): velusetrag dose 1; velusetrag dose 2; velusetrag dose 3; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): TD-5108; TD-5108; TD-5108
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gastroparesis; Diabetic; Idiopathic; Delayed gastric emptying
Impact Evaluation of the 123 Women Emergency Phone Line in Medellín, Colombia
Condition: Violence Against Women (VAW)
MeSH terms: Emergencies
Study type: Observational

Summary: 
      The purpose of this study is to determine whether the 123 women emergency phone line of
      Medellin (Colombia) leads to a reduction in the violence suffered by women, as well as in
      their psychological wellbeing and attitudes towards violence.
    

Detailed description: 
      The purpose of this study is to determine whether the 123 women emergency phone line of
      Medellin (Colombia) leads to a reduction in the violence suffered by women, as well as in
      their psychological wellbeing and attitudes towards violence.

      There is excess demand for the 123 women emergency phone line of Medellin. While on average
      10 cases are reported (excluding referrals at night by the police, between 7pm and 7:00
      a.m.), the average daily capacity of operation is 6 cases. So, is not possible for the 123
      women team to track all women who call in 24 hours. Women who cannot receive the services of
      the 123 women team only get the emergency support of the police and do not receive additional
      aid (while it is verified that the rights of women are respected and they are guided to
      relevant services). The excess of demand over the capacity of the team of the 123 women line
      represents a natural experiment.

      Women will be recruited from those who are attended by the 123 emergency women phone line
      immediately as well as from those who were only attended by emergency support of the police
      and may have received later the support of the 123 women line (control group). In a first
      instance, women will be called to verify their address. A face to face survey will be
      conducted by mid-2015.
    

Intervention name(s): 123 women emergency phone line in Medellin, Colombia
Intervention type(s): Behavioral
Intervention description(s): 123 is the emergency number in Colombia. The 123- woman line consists of supplementary emergency services to meet the demands of urgency in relation to cases of VAW. This service is implemented by the mayor of Medellin, in collaboration with the national police who is the institution in charge of managing the 123 line.
When the police attends an emergency on VCM, the call is derived to the 123- woman line. There, a team consisting of a psychologist and a lawyer serves women in crisis, as emergency services provided by the police are developed in parallel. The team verifies that the rights of women are respected and that women are oriented to the relevant services. The 123- woman line operates from 7:00 am to 7:00 pm, Monday through Friday.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Women that call the 123 emergency line in Medellín, Colombia
Safety and Efficacy of Bronchitol in Bronchiectasis
Condition: Bronchiectasis
MeSH terms: Bronchiectasis
Study type: Interventional
Phase: Phase 3

Summary: 
      Study will assess the safety and effectiveness of 12 week treatment with the study
      medication, Bronchitol, in subjects with bronchiectasis (a lung disease where patients have
      trapped, and often infected, thick, sticky mucus). Past studies have shown Bronchitol
      inhalation may help to facilitate the clearance of mucus by altering its rheology (making it
      less thick and sticky), thereby enhancing the shift of stagnant mucus from the lungs. On
      completion of the double blind phase, subjects will have the opportunity to participate in a
      52 week open label phase.
    


Intervention name(s): Mannitol; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 320mg BD 12 weeks followed by 40 weeks open label; BD for 12 weeks
Intervention MeSH terms: Mannitol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mannitol
A Study to Evaluate of Cosmetic Benefit of a Moisturising Cream in People With Blemish Prone Skin
Condition: Skin Care
Study type: Interventional

Summary: 
      This study is designed to evaluate the cosmetic benefit provided by twice daily application
      of a developmental moisturising cream with niacinamide for 8 weeks in healthy female
      participants with sensitive, oily, blemish-prone skin.
    

Detailed description: 
      This study broadly consists of two phases: screening / washout phase (5-7 day) followed by
      treatment phase (approximately of 8 weeks). Participants will be asked to return to the study
      site 1 week, 4 weeks and 8 weeks after their randomisation visit for instrumental
      measurements and clinical assessments.
    

Intervention name(s): Washout / Standard Cleanser; Test product; Positive control cleanser; Positive control moisturiser
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Participants will apply standard cleanser (Simple Kind to Skin Moisturising Facial Wash) twice daily (morning and night) with at least 8 hours between product applications. Participants will use the standard cleanser in a 5-7 day washout period and during the test phase of the study; Participants will apply 0.6 gram (g) of Test product (Moisturising Cream with Niacinamide) twice daily (morning and night) with at least 8 hours between product applications. Participants will use the test product during the test phase of the study.; Participants will apply positive control cleanser (Neutrogena Visibly Clear Spot Clearing Facial Wash) twice daily (morning and night) with at least 8 hours between product applications. Participants will use the positive control cleanser during the test phase of the study.; Participants will apply 0.6 g of positive control moisturiser (Vivatinell Acnecinamide Gel Cream) twice daily (morning and night) with at least 8 hours between product applications. Participants will use the positive control moisturiser during the test phase of the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Hepatic Function Impairment on the Pharmacokinetics of LEE011
Condition: Normal Hepatic Function; Impaired Hepatic Function
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics (PK), safety and tolerability
      of a single oral dose of LEE011 in subjects with varying degrees of impaired hepatic function
      (based on Child-Pugh classification) as compared to demographically-matched control subjects
      with normal hepatic function.
    


Intervention name(s): LEE011
Intervention type(s): Drug
Intervention description(s): 400 mg
Other intervention name(s): Ribociclib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Tolerability of CS10BR05 Inj. in Subjects With Multiple System Atrophy
Condition: Multiple System Atrophy
MeSH terms: Multiple System Atrophy; Shy-Drager Syndrome; Atrophy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of conducting phase 1 trial is to evaluate the safety and tolerability of
      autologous bone marrow-derived mesenchymal stem cells(CS10BR05) in subjects with Multiple
      System Atrophy.

      Evaluation of DLT by carotid artery(intra-arterial) injection according to dose-escalating in
      Multiple System Atrophy.
    

Detailed description: 
      Multiple system atrophy is a neurodegenerative disease of the central nervous system which is
      accompanied by signs of autonomic imbalance (orthostatic hypotension, urinary problems,
      erectile dysfunction), Parkinson's symptoms (movement decreases, limb tremors) and cerebellar
      ataxia symptoms (grogginess, pronounced incorrectly). It shows signs similar to Parkinson's
      disease, however, it doesn't show improvement of symptoms by dopaminergic drugs and occurs at
      any age.

      The clinical trial was designed as a single center, open-label, public phase 1 clinical
      trials.

      If that subject's written consent to participate in this clinical trial will be conducted the
      required examinations and tests in accordance with the study protocol.

      Then, the register for each dose step. For the final 3 subjects in the inclusion / exclusion
      criteria and be administered a drug test.

      And check the adverse events for more than four hours after administration of the
      investigational drug, and will determine whether the expression of adverse drug reaction(ADR)
      by the visit after 1 days, 14 days and 28 days.

      Except for dose administration, all subject are tested in the same schedule. As a result of
      evaluating severity of AE divided into subjective, objective in accordance with the CTCAE
      (Version 4.0) standards.
    

Intervention name(s): CS10BR05
Intervention type(s): Biological
Intervention description(s): The single injection of CS10BR05 Inj. in the carotid artery; Step 1 dose : 3.0x105cells/kg; Step 2 dose : 6.0x105cells/kg; Step 3 dose : 9.0x105cells/kg; The duration of follow up study following the single dose of CS10BR05 is 28 days.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MSA