bioihbjkbjnl/mcl2 huggingface dataset:
Preventive Program in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      This study monitor the immediate and persistent impact of a preventive complex six-month
      program specifically developed for newly diagnosed people with multiple sclerosis on fatigue,
      mental and physical fitness, and quality of life. The study determined whether changes in
      clinical function are related to changes in neurohormones, and whether the effect of therapy
      is dependent on the active approach of study participants.
    

Detailed description: 
      The patients who were newly diagnosed with MS underwent a six-month preventive comprehensive
      program, which included individual physiotherapy focused on the treatment of functional
      disorders of the loco-motor system and therapy on a neurophysiological basis, group
      psychotherapy and controlled aerobic training. The participants were examined three times -
      before the start of the physiotherapy program, immediately after its completion and six
      months apart. Influence on physical fitness (spiroergometric examination), fatigue (Modify
      Fatigue Impact Scale, fatigue scale for motor and cognitive functions), depression (Beck
      scale for evaluation of depression), admission of disease RS (Inventory of admission of
      multiple sclerosis, quality of life) life and selected neurohormones
      (dehydroepiandrosterone-DHEA, dehydroepiandrosterone sulphate - DHEAS, cortisol).
    

Intervention name(s): Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis
Intervention type(s): Behavioral
Intervention description(s): Preventive program included informations of the possibilities of physiotherapy in the treatment of multiple sclerosis focused on fatigue management - recommending lifestyle changes. Program included a the treatment of psychosomatic, viscerosomatic functional disorders by reflexively poor connection through the locomotor system using computer kinesiology, psychotherapy, manual therapy - where patients are corrected into a postural position and the joints are functionally centred, and aerobic exercise to influence fatigue and improve the performance of the cardiovascular system.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Preventive program; Multiple Sclerosis; Rehabilitation
Dornase Alfa Administered to Patients With COVID-19 (DACOVID)
Condition: COVID-19; Mechanical Ventilation
MeSH terms: COVID-19
Study type: Observational

Summary: 
      Mechanically ventilated patients with coronavirus disease 2019 (COVID-19) have a mortality of
      24-53%, in part due to distal mucopurulent secretions interfering with ventilation. Dornase
      alfa is recombinant human DNase 1 and digests DNA in mucoid sputum. Nebulized dornase alfa is
      FDA-approved for cystic fibrosis treatment. DNA from neutrophil extracellular traps (NETs)
      contributes to the viscosity of mucopurulent secretions. NETs are found in the serum of
      patients with severe COVID-19, and targeting NETs reduces mortality in animal models of acute
      respiratory distress syndrome (ARDS). Thus, dornase alfa may be beneficial to patients with
      severe COVID-19-acting as a mucolytic and targeting NETs.
    

Detailed description: 
      Demographic, clinical data, and outcomes were collected from the electronic medical records
      of five mechanically ventilated patients with COVID-19-including three requiring veno-venous
      extracorporeal membrane oxygenation (VV-ECMO)-treated with nebulized in-line endotracheal
      dornase alfa co-administered with albuterol (used to increase delivery to the alveoli),
      between March 31 and April 24, 2020. Data on tolerability and responses, including
      longitudinal values capturing respiratory function and inflammatory status, were analyzed.
    

Intervention name(s): Dornase Alfa
Intervention type(s): Drug
Intervention description(s): nebulized in-line endotracheal dornase alfa co-administered with albuterol
Other intervention name(s): albuterol
Intervention MeSH terms: Albuterol
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        mechanically ventilated patients with COVID-19
A Continuation Study To Monitor The Long Term Safety Of Patients Completing Protocols ACU-P08-020/020A
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional

Summary: 
      This is a 2 year follow up study to monitor the long term safety of the ACI 7000PDT in
      subjects who are still implanted with the ACI and have successfully completed the
      ACU-P08-020/020A studies.
    

Detailed description: 
      This is a two year follow up study designed to monitor and obtain long-term safety data of
      the ACI 7000PDT in subjects who participated and successfully completed the ACU-P08-020/020A
      studies. Subjects must be able to provide voluntary informed consent, and must sign and be
      given a copy of the written Informed Consent form prior to participating. This continuation
      study follows subjects still implanted with the ACI and includes two visits, at 12-month
      intervals, after subjects have been exited (at Month 36) from the ACU-P08-020/020A studies.
      The first visit is at Month 48 following implantation followed by a final Month 60 visit. The
      study parameters being measured at these two visits include:

        -  Specular microscopy

        -  Slit lamp and fundus examination (ocular health)

        -  Corrected and uncorrected visual acuity

        -  Manifest mid-point refraction

        -  Corneal topography

        -  Dry eye assessment

        -  Mesopic and Photopic contrast sensitivity

        -  Adverse events and complications

      All sites participating in the ACU-P08-020/020A studies were invited to participate in the
      continuation study.
    

Intervention name(s): AcuFocus Corneal Inlay ACI 7000 PDT
Intervention type(s): Device
Intervention description(s): Inlay implanted in cornea for improvement of near vision
Other intervention name(s): AcuFocus KAMRA inlay
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: presbyopia
Primary Reperfusion Secondary Stenting Trial
Condition: ST-elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      The purpose of this research project is to improve how we treat heart attacks. The study will
      assess whether it might not be better to wait a few hours before implanting the coronary
      stent into the coronary artery rather than implanting it immediately, in order to allow the
      drugs to completely dissolve the clot. This might help to reduce the risks of the clot
      migrating and damaging the heart. By delaying coronary stent implantation, we hope to be able
      to reduce the size of the infarction and reduce the risk of suffering from heart failure
      following a heart attack.
    

Detailed description: 
      The PRIMACY trial seeks to assess whether a strategy of delayed stent implantation combined
      with adjunctive anticoagulation is superior to immediate stent implantation at improving
      cardiovascular outcomes in patients with mechanically reperfused ST-elevation Myocardial
      Infarction (STEMI). The investigators hypothesize that delayed stent implantation combined
      with systemic anticoagulation and maximal antiplatelet therapy will reduce the combined
      occurrence of cardiac death, non-fatal myocardial infarction, congestive heart failure, or
      unplanned target vessel revascularization over a 9-month period.
    

Intervention name(s): Stent
Intervention type(s): Procedure
Intervention description(s): Percutaneous coronary intervention: reperfusion with a thrombectomy catheter or a small balloon angioplasty catheter, followed by coronary stenting
Other intervention name(s): Thrombectomy catheter; Balloon angioplasty catheter; Coronary stent
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Delayed stenting; Deferred stenting; Late stenting; postponed stenting; Thrombectomy; Percutaneous coronary intervention; PCI; Angioplasty; STEMI; acute myocardial infarction
An Study to Evaluate Rosuvastatin in Children and Adolescents With Familial Hypercholesterolaemia
Condition: Familial Hypercholesterolaemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being carried out to see if the study medication, rosuvastatin, is effective in
      treating familial hypercholesterolaemia in children and adolescents, and to determine the
      long term (over 2 years) safety, tolerability and efficacy of the study medication in these
      patients.

      This study will also measure levels of drug in the blood and see how well it is tolerated.
      This is known as pharmacokinetic (PK) analysis.

      At baseline only a small number of patients will participate in a single dose PK phase over
      24 hours.

      In order to see if this medication works, a control group of healthy siblings will help the
      researchers to compare certain results.
    


Intervention name(s): rosuvastatin calcium; rosuvastatin calcium; rosuvastatin calcium
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 5 mg, oral, once daily, 24 months; 10 mg, oral, once daily, 24 months; 20 mg, oral, once daily, 24 months
Other intervention name(s): Crestor; Crestor; Crestor
Intervention MeSH terms: Calcium, Dietary; Rosuvastatin Calcium; Calcium
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Familial Hypercholesterolaemia; pediatric
The Effect of Upper Limbs Motion During Single-leg Jump Landing After Anterior Cruciate Ligament Reconstruction
Condition: Anterior Cruciate Ligament Reconstruction
Study type: Observational

Summary: 
      The aim of this study is to investigate the effect of upper limbs motion on lower limb
      biomechanics and muscle activity during single-leg jump landing after anterior cruciate
      ligament reconstruction.
    

Detailed description: 
      More and more people join in different sports in recent years. But the incidence of sports
      injury also increases. And the most frequently occurring and debilitating knee injury in
      sports is rupture of the anterior cruciate ligament (ACL). Patients who aim to return to
      their preinjury sports should undergo anterior cruciate ligament reconstruction (ACLR) in
      order to maximize knee stability. The overall incidence rate of a second ACL injury within 24
      months after ACLR was nearly 6 times greater than that in healthy participants. Although many
      studies have showed about biomechanical and neuromuscular risk factors during jump landing
      which were thought to associate with the secondary injury after ACLR, these studies all
      focused on the motion of lower extremity. But actually, people often use their upper limbs to
      catch or throw a ball during jump landing in playground. Whether the upper limbs motion will
      affect the muscle coordination of lower extremity during jump landing is still unknown.
      Therefore, the purpose of our study is to investigate the effect of upper limbs motion during
      single-leg jump landing after ACLR.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Age between 20-50 years old
Retinal Venous Pressure (RVP) in Normals
Condition: Healthy
Study type: Observational

Summary: 
      Determinate the standard values of the retinal venous pressure in a cohort of healthy
      subjects.
    

Detailed description: 
      The retinal venous pressure (RVP) is an increasingly important dimension in the clinical
      assessment of retinal blood flow.

      In literature only very few and also divergent data on the retinal venous pressure in healthy
      volunteers are described. A normal value study will provide us with an up-to-date database.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy volunteers
      
Keywords: retinal venous pressure
Using Propranolol in Traumatic Brain Injury to Reduce Sympathetic Storm Phenomenon
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      Traumatic Brain Injury (TBI) is one of the leading causes of death. Severe TBT is correlated
      with an exaggerated stress response due to plasma catecholamine levels known as sympathetic
      storming. It is also autonomic dysfunction syndrome. This phenomenon is also associated with
      brain tumors, severe hydrocephalus and subarachnoid hemorrhage. Patients are presented by
      tachycardia, tachypnea hypertension, diaphoresis, dystonia, hyperthermia, and dilated pupils
      with elevated levels of plasma catecholamine and blood glucose .
    

Detailed description: 
      The sympathetic storming events can be triggered by suctioning, repositioning, or
      environmental stimuli. To differentiate sympathetic storming from similar conditions,
      symptoms and signs have to occur in TBI patients a minimum of 1 cycle per day for 3
      consecutive days (body temperature of 38.5 °C or more, heart rate at least 120 beat / min,
      systolic blood pressure > 140 mmHg, respiratory rate > 20 breaths / min, in presence of
      dystonia, diaphoresis, agitation and laboratory investigations confirm elevated serum
      catecholamines. Beta blockers has a cardio protective effect via lowering heart rate, stroke
      volume and mean arterial blood pressure which limits myocardial O2 consumptions and guards
      against myocardial infarction. They also have neuron protective effects via reducing cerebral
      blood flow thus lowering O2 and glucose consumption as cerebral metabolism is reduced.
      Propranolol a nonselective B receptor antagonists works on β1 receptors in brain, heart, and
      kidney and β 2 receptors in lungs, liver, skeletal muscles, eye and arterioles.We suppose
      that using Beta - adrenergic receptor blockers as propranolol blunts the sympathetic storming
      phenomenon as it is a nonselective β inhibitor and has a lipophilic property which enables it
      to penetrate blood brain barrier.
    

Intervention name(s): Propranolol Hydrochloride 1 MG/ML; Normal saline
Intervention type(s): Drug; Other
Intervention description(s): Propranolol 1 mg every 6 hrs in the first 24 hrs after isolated blunt traumatic brain injury; Normal Saline 1 ml every 6 hrs
Intervention MeSH terms: Propranolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Postprandial Monocyte Maturation and Vascular Dysfunction Following High-Fat Meals - Study 1
Condition: Cardiovascular Risk Factor; Lipemia
MeSH terms: Hyperlipidemias
Study type: Interventional

Summary: 
      The purpose of this research study is to examine the effect of high-fat meals on the health
      of blood vessels. In addition, the study will examine how exercise/fitness/physical activity
      impacts blood vessels after consumption of a high-fat meal.
    

Detailed description: 
      This is the first in a series of studies examining the impact of high-fat meals on blood
      vessels. During the preliminary visit of this study, eligible participants' resting metabolic
      rate, arm flow mediated dilation, and leg flow mediate dilation will be measured. They will
      complete handgrip and plantar flexion exercise tasks. Finally, they will be given a physical
      activity monitor to wear for 7 days. At their first visit, participants will eat a high-fat
      meal and blood will be drawn to measure blood vessel health. They will also repeat the arm
      flow mediated dilation, leg flow mediate dilation, handgrip, and plantar flexion exercise
      tests.
    

Intervention name(s): High-fat meal
Intervention type(s): Other
Intervention description(s): Participants will be given a serving of Marie Callendar's Chocolate Satin Pie to eat over a period of 20 minutes
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Vascular Dysfunction
Truvada Versus Truvada Plus Hepatitis B Immunoglobulin (HBIg) in Prevention of Chronic Hepatitis B Recurrence Post Liver Transplant
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this 96-week study was to evaluate the safety and antiviral efficacy of
      emtricitabine/tenofovir disoproxil fumarate (FTC/TDF, coformulated; Truvada®) with or without
      hepatitis B immunoglobulin (HBIg) in preventing the recurrence of chronic hepatitis B
      following liver transplantation, in participants who were chronically infected with hepatitis
      B prior to transplantation.

      Prior to enrollment, participants were required to have received at least 12 weeks of HBIg
      therapy following liver transplantation. Enrolled participants then received FTC/TDF plus
      HBIg for an initial 24-week pre-randomization treatment period. Participants who completed
      the pre-randomization period and who achieved sustained viral suppression were randomized to
      continue treatment with FTC/TDF with or without HBIg for an additional 72 weeks (randomized
      period). The antiviral efficacy of treatment was assessed by measuring hepatitis B virus
      levels in the blood (HBV DNA). Safety and tolerability was monitored by assessing adverse
      events and various laboratory parameters.
    


Intervention name(s): FTC/TDF; Hepatitis B Immunoglobulin (HBIg)
Intervention type(s): Drug; Drug
Intervention description(s): Emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg was administered as a fixed-dose combination tablet orally once daily.; HBIg was administered either intravenously or by intramuscular injection at a dose and frequency as prescribed by the investigative site protocol.
Other intervention name(s): Truvada
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Truvada; HBIg; Chronic Hepatitis B Recurrence; Post Orthotopic Liver Transplant
A Randomized, Double-Masked, Placebo-Controlled Two Cross Over Study Comparing the Effects of Moxaverine and Placebo on Ocular Blood Flow
Condition: Ischemia
MeSH terms: Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      It is known that several common eye diseases are associated with ocular perfusion
      abnormalities. Moxaverine is used in the therapy of perfusion abnormalities in the brain, the
      heart and the extremities because of its direct vasodilatory effects. The present study
      seeked to investigate whether moxaverine alters ocular blood flow in healthy volunteers after
      intravenous administration.
    


Intervention name(s): Moxaverine; physiological saline
Intervention type(s): Drug; Drug
Intervention description(s): intravenous administration; intravenous administration
Intervention MeSH terms: Moxaverine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Placebo-Controlled Study of INS117548 Ophthalmic Solution in Subjects With Glaucoma (P08650)
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of INS117548 ophthalmic
      solution.
    


Intervention name(s): Placebo; INS117548; INS117548; INS117548
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): One drop in each eye every 12 hours for seven days; One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days; One drop of Concentration #2 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days; One drop of Concentration #3 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Cognitive Behaviour Therapy (CBT) for Body Dysmorphic Disorder (BDD)
Condition: Body Dysmorphic Disorder
MeSH terms: Body Dysmorphic Disorders
Study type: Interventional

Summary: 
      The aim of the research is to determine if Cognitive Behaviour Therapy (CBT) specific for BDD
      is more effective than a credible non-specific form of CBT for treating BDD and its
      delusional variant in adults aged 17 or over. This will be done in a single centre randomised
      controlled trial that compares specific CBT for BDD versus non-specific CBT over 12 weeks.
      The hypotheses to be tested are that: (1) specific CBT for BDD will be more effective than
      non-specific CBT at 12 weeks (2) Treatment effects from Specific CBT will be maintained at 1
      month follow up. The main study end-point is at 12 weeks and the secondary end-point is at 1
      month follow up. A secondary aim is to explore whether delusionality (insight) as measured by
      the Brown Assessment of Beliefs and co-morbid depressed mood predicts response to treatment.
    


Intervention name(s): CBT specific for BDD; Non specific CBT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This consisted of 12 wks of 1 hr sessions (1 per week).The consisted of engagement in a developmental understanding of the problem and setting up an alternative view of the problem. Imagery rescripting followed for past aversive memories that were associated with the onset (e.g. bullying). The behaviours were aimed at either (1) threat detection and monitoring or (2) preventing feared consequences by avoidance or (3) attempts to undo the appearance concerns. The therapist aimed to help individuals identify their beliefs about processes, conduct behavioural experiments that tested out their expectations and to gradually drop the safety-seeking behaviours and test out their fears.; Anxiety Management treatment was provided once a week for 12 weeks, with each session lasting 1 hr. AM was planned to entail a therapeutic alliance, support and homework similar to the CBT group. The rationale provided was that when triggered, the person would experience a threat and negative thoughts about their appearance. This, in turn, would lead to physical symptoms of anxiety and magnify the perceived threat. The treatment consisted of (1) practising progressive muscle relaxation and breathing daily, (2) identifying triggers and physical symptoms associated with appearance-related anxiety and (3) utilising brief muscle relaxation and breathing techniques in trigger situations.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: CBT; BDD