bioihbjkbjnl/mcl2 huggingface dataset:
Choroidal Blood Flow Regulation During Isometric Exercise: Effects of Ca2+-Channel Blockade
Condition: Ocular Physiology; Regional Blood Flow
Study type: Interventional

Summary: 
      Autoregulation is the ability of a vascular bed to maintain blood flow despite changes in
      perfusion pressure. For a long time it had been assumed that the choroid is a strictly
      passive vascular bed, which shows no autoregulation. However, recently several groups have
      identified some autoregulatory capacity of the human choroid. In the brain and the retina the
      mechanism behind autoregulation is most likely linked to changes in transmural pressure. In
      this model arterioles change their vascular tone depending on the pressure inside the vessel
      and outside the vessel. In the choroid, several observations argue against a direct
      involvement of arterioles. In a previous project we were able to identify that the nitric
      oxide (NO) - system as well as the endothelin system are involved in choroidal blood flow
      regulation during isometric exercise.

      In the present study autoregulation of the choroid during isometric exercise will be
      investigated and the pressure/flow relationships will be observed in the absence or presence
      of a calcium antagonist - nifedipine.
    


Intervention name(s): Nifedipine (drug); L-Arginin (drug); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Nifedipine (Adalat®, Bayer, Leverkusen, Germany) dose: 15µg/kg bolus infusion over 5 minutes; 0.2 µg/(kg.min) maintenance dose infusion period 25 minutes; L-Arginin (Clinalfa AG, Läufelfingen, Switzerland) 30% sodium chlorid solution, dose: 1g/min over 30 minutes; Placebo
Intervention MeSH terms: Nifedipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Nifedipine; Choroidal blood flow; Choroidal autoregulation; Isometric exercise
Developing an Atlas to Teach Nurses to Clean Micro-instruments Used in Cataract Surgery: Effect on Patient Safety
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      Aims and objectives The purpose of this study was to develop an atlas to explore the effect
      of micro-instrument cleaning on the safety of cataract surgery.

      Background Cataract surgery safety is affected by many factors, the most influential of which
      is the quality of instrument cleaning. Previous studies focused on the reaction in the eye
      after cataract surgery. None offered a solution for manually cleaning ophthalmic
      micro-instruments or response data for surgical instruments after cataract surgery.

      Design The study was designed to collect quantitative data derived from postoperative ocular
      evaluation.

      Methods We developed an atlas that details micro-instrument cleaning that could be used to
      train nurses to have this skill. A total of 120 cataract patients were divided evenly into
      experimental and control groups. In the experimental group, cataract surgery was undertaken
      using microsurgical instruments that were cleaned by the atlas-trained nurses. In the control
      group, micro-instruments were used that had been cleaned by non-atlas-trained nurses. All the
      patients underwent the same postoperative tests: anterior chamber cell counts and visual and
      intraocular pressures on postoperative days (PODs) 1, 3, 7, and 14.
    

Detailed description: 
      A single surgeon conducted all of the surgery and follow-up all patients
    

Intervention name(s): atlas of micro-instrument
Intervention type(s): Other
Intervention description(s): Nurses after training can improve the instrument cleaning quality, reduce the reaction after cataract surgery
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: anterior chamber flare; cataract; intraocular pressure; micro-instrument; photograph-based atlas; visual; training nurse
The Modular Protocol for Mental Health (MPMH)
Condition: Major Depressive Disorder; Generalized Anxiety Disorder; Posttraumatic Stress Disorder; Social Anxiety Disorder; Panic Disorder; Agoraphobia; Obsessive-Compulsive Disorder; Illness Anxiety Disorder
MeSH terms: Anxiety Disorders; Depressive Disorder; Depressive Disorder, Major; Obsessive-Compulsive Disorder; Stress Disorders, Post-Traumatic; Panic Disorder; Phobia, Social; Agoraphobia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Currently, our best psychological treatments for anxiety and mood disorders only focus on
      individual diagnoses. So, there are separate treatments for Panic Disorder, or Depressive
      Disorder, or Social Anxiety, etc. These 'diagnosis-specific' treatments work well for people
      whose problems fit neatly into a single diagnosis. However, they work far less well for
      people with complex problems involving multiple diagnoses, and 50% of patients fail to
      respond well to these existing treatments.

      The purpose of this study is to test a new psychological treatment for anxiety and mood
      problems (the Modular Protocol for Mental Health [MPMH]). Instead of focusing on any single
      diagnosis, MPMH combines the best treatment techniques into 10 modules to target problems
      common across all of the different mood and anxiety diagnoses (e.g., intense emotions,
      negative thinking, upsetting memories, distressing habits). MPMH should therefore be a better
      treatment for the large numbers of individuals whose problems do not fit neatly into a single
      diagnosis and for whom any treatments targeting a single diagnosis would leave significant
      difficulties unaddressed.
    


Intervention name(s): The Modular Protocol for Mental Health; Treatment-as-usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This intervention is based on evidence-based cognitive-behavioural approaches to psychological disorders and offers a flexible approach to treatment delivery that targets the maladaptive processes common to mood and anxiety disorders.; This intervention will consist of psychological therapies delivered by high-intensity therapists or clinical psychologists.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Efficacy Phase IIa Study of CVXL-0107 in Advanced Parkinson's Disease
Condition: Idiopathic Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      CVXL-0107 a glutamate release inhibitor, has shown evidence of antiparkinsonian and
      antidyskinetic activity in a macaque model and has shown a significant effect on the
      UPDRS-III (Movement Disorder Society - Unified Parkinson's Disease Rating Scale) while "ON",
      as well as an increase of "ON-time" without dyskinesia or without troublesome dyskinesia in a
      previous phase 2a proof of concept study. This study will confirm the efficacy of CVXL-0107
      in combination with optimal dose of levodopa on motor symptoms of Parkinson's disease (PD) .
    

Detailed description: 
      Phase IIa study, 1:1 randomized, double blind placebo- controlled, with cross-over. Each
      volunteer patient will be randomly assigned to receive CVXL-0107 or placebo as add-on PD
      therapy and crossed-over to the other arm in the second sequence of the study. They will be
      assessed during an acute levodopa challenge test with one intake of the study drug or placebo
      with a supra-optimal dose of levodopa after 2 weeks of daily treatment with the same study
      drug or placebo. Patients will be cross-overed to the other treatment and reassessed during a
      second acute levodopa challenge test after 2 weeks of daily treatment with the study drug or
      the placebo. The study will evaluate the anti-PD and the anti-dyskinesia efficacy of
      CVXL-0107 as measured by MDS-UPDRS part III (Movement Disorder Society - Unified Parkinson's
      Disease Rating Scale) and on levodopa-induced dyskinesia as measured by the AIMS (Abnormal
      Involuntary Movement Scale).
    

Intervention name(s): CVXL-0107; Placebo; Levodopa
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Levodopa
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Mindfulness Training in Military Spouses
Condition: Psychological Stress
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      This project aims to contextualize the delivery of mindfulness training for military spouses
      and evaluate its effectiveness on measures of executive functions and psychological
      well-being.
    

Detailed description: 
      In addition to psychological and physical health challenges that military service members
      face, military deployment is known to have deleterious effects on the entire family unit. The
      January 2010 issue of the New England Journal of Medicine reported medical data from over
      250,000 wives of deployed soldiers. These women suffered from clinically significant levels
      of anxiety, depression, sleep disturbances, and adjustment disorders. Thus, the psychological
      profile of military spouses sadly parallels that of the military servicemembers.
      Unfortunately, the effect of deployment on the psychological health in military spouses is
      largely unstudied, and very few resilience-building programs are available for military
      families.

      Prior research showed that mindfulness training (MT), as a resilience-building program in
      civilian and military servicemembers, can effectively protect against degradation in of
      executive functions (i.e., attention, working memory) and benefit psychological well-being
      over high-demand intervals. While research evidence mounts that MT is beneficial for service
      members, there is almost no research examining the impact of MT on military spouses'
      cognitive functioning and psychological well-being.

      The present study aims to investigate if MT may successfully benefit cognitive functioning
      and psychological well-being in military spouses.
    

Intervention name(s): Mindfulness training
Intervention type(s): Behavioral
Intervention description(s): The present MT program includes topics related to mindfulness, emotion regulation, and connection. It will be delivered in short, weekly sessions.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be assigned into three groups: (i) a mindfulness training with spouse trainers (MT-ST, n = 60) that will receive the training from peers who underwent an extensive training practicum; (ii) a mindfulness training with mindfulness expert trainer group (MT-ME, n = 30) that will receive the training from a mindfulness expert trainer; and (ii) a wait-list control group (WLC, n = 30) that will be tested before and after a no-training interval and may receive MT at a later time after their second testing if they are interested.
Masking: None (Open Label)
Primary purpose: Basic Science
Mechanical Recanalization With Flow Restoration in Acute Ischemic Stroke
Condition: Acute Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to collect data on the use of the SOLITAIR FR device for
      treatment of acute ischemic stroke with large artery occlusion i.e. to investigate, whether
      the application of SOLITAIR is a safe and feasible method for interventional recanalization
      of large vessels with favorable patient outcome in acute stroke therapy.
    


Intervention name(s): Solitaire FR, ev3
Intervention type(s): Device
Intervention description(s): Placement of the stent in the occluded vessel segment, withdrawal in its unfolded state.
Other intervention name(s): device used: Solitaire FR, ev3, USA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stroke; mechanical recanalization; self-expanding stent; Solitaire
A Study To Assess The Quality Of Bone In Patients Taking Oral Ibandronate Versus Placebo
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to estimate the effect of oral Boniva (ibandronate sodium)taken
      once monthly versus placebo on bone quality and strength at the hip at one year.
    


Intervention name(s): ibandronate
Intervention type(s): Drug
Intervention MeSH terms: Ibandronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Osteoporosis; bisphosphonates; bone
The Effects of CBD Isolate on Menstrual-Related Symptoms
Condition: Menstrual Discomfort
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this open-label clinical trial is to compared two different doses for treating
      menstrual-related symptoms in individuals who experience regular menstrual cycles (occurring
      for 4-8 days every 21-28 days). The main question it aims to answer is:

      (1) if there are changes in menstrual-related symptoms from baseline compared to all 3-months
      of cannabidiol (CBD) isolate consumption.

      Participants will complete a monthly baseline measure after they stop menstruating followed
      by taking CBD twice daily (BID) for five days for three menstrual cycles and complete the
      same measures. Researchers will compare 160mg of daily CBD isolate to 320mg of CBD isolate to
      see if there are differential effects on menstrual-related symptoms (MRS).
    


Intervention name(s): Cannabidiol
Intervention type(s): Drug
Intervention description(s): Cannabidiol is a non-psychoactive cannabinoid obtained from the cannabis plant.
Intervention MeSH terms: Cannabidiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cannabidiol; CBD; menstruation
Application and Generalization of Flutter Mucus Clearance Device
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive; Chronic Disease
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the clinical outcome and safety of flutter mucus
      clearance devices.
    

Detailed description: 
      Respiratory diseases are still increasing in elder population. Sputum detaining is a common
      contributing factor to acute exacerbation. The fluttering mucus clearance technique is
      expected to be a physical assisting therapy enhancing airway secretion clearance but need
      more clinical randomized control trial evidence.
    

Intervention name(s): flutter mucus clearance device
Intervention type(s): Device
Intervention description(s): five minutes every session, four sessions per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Pulmonary Disease, Chronic Obstructive; flutter; airway clearance; sputum; Physical Therapy Techniques
A Multicenter Extension Study of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease
Condition: Gaucher Disease
MeSH terms: Gaucher Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      A protocol to extend the assessment of the safety and efficacy of taliglucerase alfa in
      pediatric subjects (2 to <18 years old) with symptoms and clinical manifestations of Gaucher
      disease who completed treatment in Protocols PB-06-002 (switchover study from imiglucerase)
      or PB-06-005 (naïve treatment with taliglucerase alfa).
    


Intervention name(s): Taliglucerase alfa
Intervention type(s): Drug
Intervention description(s): Taliglucerase alfa for infusion every two weeks for 24 months
Other intervention name(s): prGCD, plant cell expressed glucocerebrosidase
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Gaucher disease; pediatrics
Endocrine and Emotional Effects of Lisdexamfetamine and d-Amphetamine.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will compare the acute emotional and endocrine effects of equivalent doses of
      lisdexamfetamine and amphetamine in healthy subjects. In addition the pharmacokinetics and
      effects of the amphetamines on aspects of social cognition are investigated.
    


Intervention name(s): Lisdexamfetamine, d-amphetamine, Placebo; d-amphetamine, Placebo, Lisdexamfetamine; Placebo, Lisdexamfetamine, d-amphetamine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Elvanse (Lisdexamfetamine): 100mg p.o, single dose; d-Amphetamine: 40.3mg p.o, single dose; Placebo: Capsules containing mannitol looking identical to lisdexamphetamine and d-Amphetamine.; Elvanse (Lisdexamfetamine): 100mg p.o, single dose; d-Amphetamine: 40.3mg p.o, single dose; Placebo: Capsules containing mannitol looking identical to lisdexamphetamine and d-Amphetamine.; Elvanse (Lisdexamfetamine): 100mg p.o, single dose; d-Amphetamine: 40.3mg p.o, single dose; Placebo: Capsules containing mannitol looking identical to lisdexamphetamine and d-Amphetamine.
Other intervention name(s): Lisdexamfetamine=Elvanse, d-amphetamine=d-amphetamine sulfate; Lisdexamfetamine=Elvanse, d-amphetamine=d-amphetamine sulfate; Lisdexamfetamine=Elvanse, d-amphetamine=d-amphetamine sulfate
Intervention MeSH terms: Amphetamine; Lisdexamfetamine Dimesylate; Dextroamphetamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Bioequivalence Study of Ondansetron Orally Disintegrating Tablets 8mg Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The purpose of this study is to compare the single-dose oral bioavailability of Ondansetron 8
      mg orally disintegrating tablets of Ohm Laboratories (A subsidiary of Ranbaxy
      Pharmaceuticals, USA) with Zofran ODT® 8 mg orally disintegrating tablets of Cardinal health,
      UK for GlaxoSmithKline, USA in healthy, adult, human, male subjects under fed condition.
    

Detailed description: 
      The study was conducted as an open label, balanced, randomised, two-treatment, two-period,
      two-sequence, single-dose, crossover bioavailability study comparing Ondansetron 8 mg orally
      disintegrating tablets of Ohm Laboratories (A subsidiary of Ranbaxy Pharmaceuticals, USA)
      with Zofran 8 mg ODT® orally disintegrating tablets (containing 8 mg of ondansetron)
      manufactured by Cardinal health, UK for GlaxoSmithKline USA, in healthy, adult, human, male
      subjects under fed condition.

      During each period of the study after an overnight fast of at least 10 hours a high-fat
      high-caloric breakfast was served and 30 minutes after start of high-caloric breakfast, a
      single oral dose of either test or reference product was administered by placing the tablet
      on tongue till it dissolved and then swallowed it using 240 mL of drinking water at ambient
      temperature under supervision of a medical officer.

      During the course of the study, safety parameters including vital signs, clinical
      examination, medical history and clinical laboratory safety tests (hematology, biochemical,
      serology parameters and urine analysis) were assessed and laboratory parameters of hematology
      and biochemistry were repeated at the end of the study.
    

Intervention name(s): Ondansetron
Intervention type(s): Drug
Intervention description(s): Orally Disintegrating Tablets 8 mg
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Tuina for Patients With Chronic Neck Pain
Condition: Chronic Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The aim is to evaluate whether tuina is more effective and cost-effective than no
      intervention waiting list to reduce neck pain measured on a visual analogue scale in patients
      suffering from chronic neck pain.
    

Detailed description: 
      Objective: To evaluate whether tuina is more effective and cost-effective than no
      intervention waiting list to reduce neck pain measured on a visual analogue scale in patients
      suffering from chronic neck pain.

      Study Design: Open single-centre randomized two-armed controlled trial. Setting: The study
      will be performed at a University out-patient clinic specialized in Integrative Medicine,
      with experience in the treatment of chronic pain.

      Participants: 88 outpatients with chronic neck pain, who will be randomly allocated to two
      groups (tuina, or no intervention (control)).

      Intervention: Patients receive either six tuina treatments within 3 weeks or no additional
      intervention.

      Main outcome measure: The primary outcome is the mean neck pain intensity over the last seven
      days on a visual analogue scale (Huskisson, 1974) (VAS, 0-100 mm, 0 = no pain, 100= worst
      imaginable pain) after four weeks.
    

Intervention name(s): tuina; no intervention
Intervention type(s): Other; Other
Intervention description(s): Patients in the tuina group will receive a tuina therapy (also known as Chinese massage). A Chinese massage lasts about 20 to 30 minutes. A series of 6 sessions with 2 treatments per week is applied.; Patients in the no intervention waiting list group will not receive a study intervention. They will continue their respective pre-study therapy during the study period.
Other intervention name(s): chinese massage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neck pain; tuina