bioihbjkbjnl/mcl2 huggingface dataset:
Routine Antenatal Care Versus Screening and Treatment of Malaria in Pregnancy in Rwanda
Condition: Malaria in Pregnancy
MeSH terms: Malaria
Study type: Interventional

Summary: 
      The main aim of this study is to test the primary hypothesis that the addition of
      intermittent screening and treatment of malaria in pregnant women (ISTp) who receive routine
      antenatal care (ANC) in health facilities in high malaria transmission areas in Rwanda will
      reduce malaria prevalence among pregnant women when compared to routine antenatal cares
      services alone.
    

Detailed description: 
      More specifically, the primary objective is to understand the effect of ISTp in a context
      where routine antenatal care does not include malaria chemoprohylaxis and whether this
      intervention is protective against malaria during pregnancy. The secondary objective is to
      determine whether this intervention results in an improvement in other key maternal and
      newborn health outcomes including maternal anemia, low birth weight and prematurity. The
      third objective is to determine the feasibility, effectiveness and acceptability of ISTp
      among women who receive ISTp and among health workers who deliver this intervention.

      This study will establish if testing and treating pregnant women is effective, feasible and
      whether it adds an additional burden to the work already being undertaken by facility-based
      health workers who provide antenatal care services. It is expected that the study will result
      in information to develop appropriate approaches that can be implemented in Rwanda in the
      prevention of malaria in pregnancy in addition to the use of preventive measures such as
      insecticide treated mosquito nets (ITNs) and case management. This information may
      potentially also be used by other countries with similar patterns of malaria transmission.
    

Intervention name(s): IST
Intervention type(s): Diagnostic Test
Intervention description(s): Women in the control group will receive routine care, which does not include testing for malaria with a rapid diagnostic test unless symptomatic for malaria. Women in the intervention group will receive this additional testing for malaria at each antenatal care, regardless of whether she is symptomatic for malaria.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Health facilities in high malaria transmission zones were pair matched and then randomized to be an intervention or a control facility.
Masking: Single (Participant)
Primary purpose: Prevention
Interleukin-1 Blockade in Recently Decompensated Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The RED-HART is a randomized double-blinded placebo-controlled study of Anakinra (IL-1
      blocker) in patients with recently decompensated heart failure to determine the safety and
      efficacy in terms of aerobic exercise capacity and ventilatory efficiency measured with a
      cardiopulmonary exercise test.
    


Intervention name(s): Anakinra (weeks 1-2); Anakinra (weeks 3-12); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Anakinra 100 mg daily for weeks 1 and 2
Other intervention name(s): Anakinra 100 mg daily for weeks 3 through 12; Placebo daily for week 1 through 12
Intervention MeSH terms: Interleukin 1 Receptor Antagonist Protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Carotid Artery Neovascularization in Takayasu's and Giant Cell Arteritis
Condition: Takayasu's Arteritis; Giant Cell Arteritis; Arteritis; Vasculitis; Aortitis
MeSH terms: Polymyalgia Rheumatica; Giant Cell Arteritis; Vasculitis; Arteritis; Takayasu Arteritis; Aortic Arch Syndromes; Aortitis; Neovascularization, Pathologic
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the ability of contrast enhanced carotid ultrasound
      to serve as an indicator of disease activity in patients with Takayasu's arteritis or Giant
      Cell arteritis and to determine if patients with active arteritis have a thickening of their
      blood vessel walls compared to healthy people of the same age and gender.
    

Detailed description: 
      Takayasu's arteritis and Giant Cell arteritis are chronic, relapsing diseases of the large
      arteries which can lead to significant narrowing of the arteries through episodes of
      inflammation within the artery walls. The changes in the vessel walls will be determined by
      an ultrasound test looking at and measuring: carotid vessel wall changes called carotid
      Intimal-Media Thickness (cIMT) and the presence of new blood vessels (neovascularization)
      using a contrast agent. Ultrasound findings will be correlated with markers of inflammation
      in the blood, findings from other radiology studies (such as MRI) already ordered as part of
      routine clinical care, and physical exam findings and symptoms of consistent with disease
      activity. 15 arteritis patients and 5 healthy controls will be recruited.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Takayasu's arteritis or giant cell arteritis will be screened from the
        clinics of the Vasculitis Clinic and the Vascular Medicine Clinic at the Cleveland Clinic.
      
Keywords: Takayasu's arteritis; Giant Cell arteritis; Arteritis; Vasculitis; Aortitis; Disease Activity; Carotidynia; Neovascularization; Carotid Intima Media Thickness
Assessment of a Drama Workshop Program for Immigrant and Refugee Adolescents
Condition: Learning Disabilities
MeSH terms: Learning Disabilities
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a drama workshop program for immigrant and
      refugee youth is effective in reducing impairment in high school students presenting learning
      difficulties.
    


Intervention name(s): Group tutoring program; Theatre workshops
Intervention type(s): Other; Other
Intervention description(s): Academic in-class intervention that focuses on differentiated academic instruction and improved overall academic adjustment. In each classroom assigned to the tutorship intervention, two academic resource assistants will provide weekly in-class support to students for the same length of time than the drama workshop (75 minutes, once a week), with the teacher present in the classroom.; The theatre expression workshops will run for 12 weeks, with one 75-minute workshop per week. They will be incorporated into the regular class timetable and will be run by the two members of the intervention team who have training in theatre and psychology, and the homeroom teacher, whose level of direct involvement will increase gradually as he or she becomes familiar with the workshops.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Dramatherapy; Group tutoring activities; Impairment; Emotional and behavioural problems; Learning difficulties
Immunogenicity and Safety Study in Infants of GlaxoSmithKline Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine
Condition: Poliomyelitis; Tetanus; Acellular Pertussis; Haemophilus Influenzae Type b; Diphtheria; Hepatitis B; Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines
MeSH terms: Hepatitis A; Influenza, Human; Hepatitis B; Tetanus; Diphtheria; Poliomyelitis; Hepatitis; Tetany
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the immunogenicity and safety of Infanrix hexa™ (DTPa-HBV-IPV/Hib) when
      administered as a primary vaccination course to Indian infants according to a 6-10-14 weeks
      or a 2-4-6 months schedule.
    


Intervention name(s): Infanrix hexa™
Intervention type(s): Biological
Intervention description(s): Intramuscular, three doses
Other intervention name(s): DTPa-HBV-IPV/Hib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Infanrix hexa™; Primary vaccination; India; combination vaccine; infants
Double Blind Randomized Study Into the Efficacy of Codeine Phosphate Analgesia After Cleft Palate Repair in Infants
Condition: Cleft Palate Repair
MeSH terms: Cleft Palate
Study type: Interventional
Phase: Phase 4

Summary: 
      This study examines the analgesic efficacy of codeine phosphate. It is compared to placebo in
      infants receiving morphine after surgery. Codeine may be effective enough to make morphine
      unnecessary.
    


Intervention name(s): Codeine Phosphate Analgesia
Intervention type(s): Drug
Intervention MeSH terms: Codeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Keywords: codeine phosphate analgesia
Mindfulness-based Cognitive Therapy for Individuals With Multiple Chemical Sensitivity
Condition: Multiple Chemical Sensitivity
MeSH terms: Hypersensitivity; Multiple Chemical Sensitivity
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the effect of mindfulness-based cognitive therapy
      (MBCT) on physical symptoms attributed to chemical exposures, psychological distress, illness
      worry, quality of life, and illness perceptions in patients suffering from multiple chemical
      sensitivity (MCS). Furthermore, a secondary objective is to evaluate whether a possible
      symptom reduction is mediated by an increased level of mindfulness.

      The primary hypothesis is that the self-reported severity of MCS symptoms and the degree to
      which chemical exposures causes symptoms and the impact on daily life will be significantly
      improved in the MBCT treatment group as compared to the control group.
    


Intervention name(s): Mindfulness-based Cognitive Therapy (MBCT)
Intervention type(s): Behavioral
Intervention description(s): MBCT is partly based on the mindfulness-based stress reduction program (MBSR), developed by Jon Kabat-Zinn and colleagues, and partly on cognitive therapy for depression, the latter influence particularly expressed through the aspect of "decentering", meaning not accepting the content of thoughts as facts and not identifying with the thought. The MBCT programme in this study includes 2½ hours of training once a week for 9 weeks. In addition, participants are encouraged to practice at home for up to 45 min per day, 6 days a week during the entire course.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple chemical sensitivities; MCS; Mindfulness-based cognitive therapy; MBCT
To Study the Absorption, Distribution, Metabolism and Excretion of AZD1305
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to learn more about how AZD1305 is handled by the body, i.e the
      absorption, distribution, metabolism and excretion of AZD1305.
    


Intervention name(s): AZD1305; AZD1305
Intervention type(s): Drug; Drug
Intervention description(s): oral solution, single dose; iv infusion, single dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AZD1305; ADME; pharmacokinetic; Absorption; distribution; metabolism; excretion
Determining the Specificity of High Definition Electrical Brain Stimulation Using Simultaneous Magnetoencephalography
Condition: Real HD-tDCS; Sham HD-tDCS; Visual Task; Motor Task; Auditory Task; Working Memory Task
Study type: Interventional

Summary: 
      Non-invasive human brain stimulation using weak transcranial direct-current stimulation
      (tDCS) has been thousands of times in research studies over the past fifteen years as a
      therapy to help improve the effectiveness of repeated training sessions (e.g., hand exercises
      in the context of daily physiotherapy), due to its safety, tolerability, convenience and
      cost-effectiveness. tDCS works by temporarily enhancing brain activity during performance of
      a specific task, helping with learning and training.

      The investigators will use magnetoencephalography (MEG) brain imaging to view the real-time
      effects of high definition (HD) tDCS on several brain areas involved in vision, hearing,
      movement, and memory. The investigators hypothesize that changing the task (auditory, visual
      or memory task) but keeping the position of the electrodes over the motor cortex will result
      in modulation of brain activity in only the central target motor area, and not on non-target
      temporal, occipital or pre-frontal areas.
    


Intervention name(s): HD-tDCS
Intervention type(s): Device
Intervention description(s): HD-tDCS non-invasive brain stimulation using this same device (Soterix) has been designated a 'non-significant risk' by the US FDA.
Other intervention name(s): High Definition Transcranial Direct Current Stimulation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Perceptions and Representations of Cancer Chemotherapy
Condition: Lung Cancer
Study type: Observational

Summary: 
      Qualitative study on data from interviews such patients, relatives and doctors involved in
      the implementation of cancer care. Framework type of method using grounded theory
    

Detailed description: 
      The word chemotherapy itself, because it belongs to the secular knowledge and therefore Doxa
      is a hard word, which stores what it is stable, common and therefore impersonal. It has the
      properties of a symbol, that is to say that joint several meanings, some of which are
      contradictory.

      The objective of the research:

      To determine the perceptions and representations of chemotherapy, its physical impacts,
      psychological and relational.

      To qualitatively compare the performances of chemotherapy as it has an end as scheduled for
      adjuvant chemotherapy, or endless precise as in the palliative chemotherapy
    

Intervention name(s): semi-structured interview conducted by a clinical psychologist; semi-structured interview conducted by a psychiatrist specialized in psycho-oncology
Intervention type(s): Other; Other
Intervention description(s): semi-structured interview conducted by a clinical psychologist; semi-structured interview conducted by a psychiatrist specialized in psycho-oncology
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        -  30 major Patients with lung cancer requiring chemotherapy either as palliative or
             adjuvant as surgical treatment

          -  30 significant others (relatives) major applicant lung cancer patients chemotherapy
             either palliation or as adjuvant to surgery

          -  15 Doctors oncologists performing either chemotherapy as palliative or adjuvant as
             surgical treatment
Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex)
Condition: Dupuytren's Contracture
MeSH terms: Dupuytren Contracture; Contracture
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the impact of Xiapex treatment on the range of motion (ROM) of the
      affected fingers and the patient and physician reported treatment satisfaction and disease
      severity and their relation to ROM. Recovery to normal activities, recovery time (How long
      overall, time to use hand, time to return to work or daily activities, amount of work or
      daily activity time missed or reduced and affects on productivity and daily activities) will
      be assessed via patient diary. Use of concomitant analgesic medications will be recorded and
      total healthcare resource utilization (HCRU).
    


Intervention name(s): Xiapex
Intervention type(s): Drug
Intervention description(s): Xiapex 0.58 mg in diluent, 0.25 ml for MP joints and 0.20 ml for PIP joints, injection to cord over joint using either 26 or 27 gauge needle, maximum 3 injections with 30 days interval between injections to any single site, maximum 5 injections in this protocol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dupuytren's; treatment; injection; recovery; health care resources
Cilostazol Stroke Prevention Study for Antiplatelet Combination
Condition: Noncardioembolic Cerebral Infarction
MeSH terms: Cerebral Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      To examine the efficacy and safety of dual antiplatelet therapy (DAPT) including cilostazol
      (Pletaal OD Tablet ®) in comparison with antiplatelet monotherapy (excluding cilostazol) for
      secondary prevention of ischemic stroke in high-risk patients for stroke
    


Intervention name(s): aspirin; clopidogrel; cilostazol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Aspirin (81mg or 100mg) will be orally administered once daily.The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.; Clopidogrel (50mg or 75mg) will be orally administered once daily.The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.; Cilostazol (100mg twice daily) will be orally administered. The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.
Other intervention name(s): Bayaspirin; Plavix; Pletaal OD Tablet
Intervention MeSH terms: Aspirin; Cilostazol; Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Noncardioembolic cerebral infarction; Dual antiplatelet therapy (DAPT); Cilostazol; Aspirin; Clopidogrel
The Effect of Tramadol on Interscalene Brachial Plexus Block
Condition: Shoulder Fracture; Shoulder Dislocation; Rotator Cuff Injury; Shoulder Arthritis
MeSH terms: Shoulder Dislocation; Rotator Cuff Injuries; Shoulder Fractures
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of our study is to evaluate the effect of tramadol as an adjunct to ropivacaine
      local anesthetic solution in interscalene brachial plexus block for shoulder surgery.
    


Intervention name(s): Ropivacaine - Tramadol; Ropivacaine
Intervention type(s): Drug; Drug
Intervention description(s): Interscalene block using ropivacaine plus tramadol; Interscalene block using ropivacaine
Intervention MeSH terms: Tramadol; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
An Open Label Study That Compares Varenicline to Transdermal Nicotine Patch for Smoking Cessation
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 3

Summary: 
      Open-label comparison of standard 12-week regimen of varenicline with standard 10-week
      regimen of transdermal nicotine patch for smoking cessation.
    


Intervention name(s): varenicline (CP-526,555)
Intervention type(s): Drug
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Safety and Efficacy of Activated Recombinant Human Factor VII in Cirrhotic Patients Undergoing Partial Hepatectomy
Condition: Acquired Bleeding Disorder; Cirrhosis
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is conducted in Asia. The aim of this trial is to evaluate the haemostatic
      efficacy of activated recombinant human factor VII in cirrhotic patients scheduled to undergo
      partial hepatectomy due to liver cancer or benign tumours.
    


Intervention name(s): activated recombinant human factor VII; activated recombinant human factor VII; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): An initial bolus dose of 50 mcg/kg body weight (BW) followed by 50 mcg/kg BW every second hour until completion of surgery; An initial bolus dose of 100 mcg/kg body weight (BW) followed by 100 mcg/kg BW every second hour until completion of surgery; An initial placebo bolus dose followed by placebo every second hour until completion of surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pacing Activity Self-management for Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Given the lack of evidence in support of pacing self-management for patients with musltiple
      sclerosis (MS), it is examined whether physical behavior and health status of patients with
      MS improve in response to a pacing self-management program. The effects of pacing will be
      compared with those observed when applying relaxation therapy to patients with MS.
    

Detailed description: 
      Up to 50 patients fulfilling the criteria for the diagnosis of multiple sclerosis (MS) will
      be randomized to either 3 weeks of pacing activity self-management or relaxation therapy.
      Both treatment groups will receive 3 weekly sessions spread over 3 consecutive weeks. All
      treatments will be delivered by occupational therapists or physiotherapists. One treatment
      session lasts for about 45 minutes each.
    

Intervention name(s): pacing; relaxation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 3 one-on-one sessions weekly for 3 consecutive weeks; 3 one-on-one sessions weekly for 3 consecutive weeks
Other intervention name(s): activity self-management; activity management; Schultz relaxation; visualisation; Jacobson relaxation; stress management
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: neurology; physiotherapy; physical therapy; occupational therapy; stress management; activity management; treatment
Carotid Atherosclerotic Plaque Study
Condition: Atherosclerosis
MeSH terms: Atherosclerosis; Plaque, Atherosclerotic
Study type: Observational

Summary: 
      First, to establish a comparison of the pathophysiology of carotid atherosclerosis and the
      genetic and environmental variables that cause those plaques to become symptomatic. Second,
      to differentiate between vulnerable plaque and other types of plaque using ultrasound
      elastography, MRI data, trans-cranial doppler along with RF (radio frequency) analysis of
      back-scattered ultrasonic echoes.
    

Detailed description: 
      This is a multi-investigator study based on the pathophysiology of carotid atherosclerosis
      and the variables that cause certain plaques to become symptomatic.Patients enrolled in this
      study will be those patients undergoing a carotid endarterectomy. This will include both
      symptomatic and asymptomatic patients, and there are a variety of atherosclerotic risk
      factors representing this patient population.Patients may or may not have had strokes or
      transient ischemic attacks (TIAs).Pre-operatively patients will be reviewed for their medical
      history and atherosclerotic risk factors. Plaque removed during routine carotid
      endarterectomy will be examined for study purposes.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing carotid endarectomy