bioihbjkbjnl/mcl2 huggingface dataset:
Study to Demonstrate Consistency of Three Lots of a Live-attenuated Chikungunya Virus Vaccine Candidate in Healthy Adults
Condition: Chikungunya Virus Infection
MeSH terms: Virus Diseases; Chikungunya Fever
Study type: Interventional
Phase: Phase 3

Summary: 
      This was a prospective, randomized, double-blinded, multicenter Phase 3 clinical study
      investigating three Lots of VLA1553 at the final dose. Overall 409 healthy subjects aged 18
      to 45 years were randomized into the study.
    

Detailed description: 
      This was a prospective, randomized, double-blinded, multicenter Phase 3 clinical study
      investigating three Lots of VLA1553. Overall 409 healthy subjects aged 18 to 45 years were
      randomized into the study, approximately136 subjects per VLA1553 Lot. Subjects were
      block-randomized in a 1:1:1 ratio into the three study arms to receive one of three Lots of
      VLA1553 as a single i.m. vaccination. The primary objective was to demonstrate Lot-to-Lot
      manufacturing consistency of VLA1553 28 days following the single vaccination.
    

Intervention name(s): Biological Vaccine VLA1553
Intervention type(s): Biological
Intervention description(s): Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: VLA1553; Chikungunya Virus Infection; CHIKV; Live-attenuated Chikungunya virus vaccine
A Prospective Comparative Study of Induction of Labor With a Cervical Ripening Double Balloon vs Foley Catheter
Condition: Induction of Labor; Cesarean; Endometritis
MeSH terms: Endometritis
Study type: Interventional

Summary: 
      Hypothesis: The induction of labor in patients with unfavorable Bishop score is a challenging
      obstetrical process, and may be influenced or complicated by the cervical ripening method
      used. We will conduct a comparative study of the foley catheter vs the cervical ripening
      double balloon (Cook medical, GPN: G48149). We will compare the failure rates, cesarean
      section rate, infections and postpartum complications, especially endometritis.
    

Detailed description: 
      We will conduct a comparative study of the foley catheter vs the cervical ripening double
      balloon (Cook medical, GPN: G48149). We will compare the failure rates, cesarean section
      rate, infections and postpartum complications, especially endometritis. The study will
      include 200 parturients, 100 primiparous and 100 multiparous women. We will randomize each
      group to induction with the foley catheter or the cervical ripening double balloon. We will
      compare the failure rates, cesarean section rate, infectious and other postpartum
      complications, especially endometritis.
    

Intervention name(s): Mechanical induction of labor; Double Balloon; Foley Catheter
Intervention type(s): Device; Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Induction of labor; Cesarean; Endometritis; Foley; Infections
Prediction of the Answer to the Treatment by Biotherapies for Naive Spondyloarthritis by Combinatorial Analysis of Serum Biomarkers
Condition: Spondylitis, Ankylosing
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional

Summary: 
      The aim of this trial is the caracterisation of a predicting algorithm of the answering
      response for patients with etanercept treatment in spondyloarthritis disease.

      This algorithm will help to target patients patients who have a risk / benefit important for
      etanercept treatment.
    

Detailed description: 
      Spondyloarthritis (or spondyloarthropathy) is an inflammatory rheumatic disease that causes
      arthritis. It differs from other types of arthritis because it involves the sites where
      ligaments and tendons are attached to bones called "entheses."

      All patients should get physical therapy and make exercises for joints. Exercises that
      promote spinal extension and mobility are the most recommended.

      Non-steroidal anti-inflammatory drugs (NSAIDs) are the first line treatment for
      spondylarthritis. NSAIDs are effective when they are used continuously or at the request, in
      a short or long-term use. However, physicians have to be aware of potential cardiovascular,
      renal or gastro-intestinal secondary effects when they prescribe NSAIDs. After NSAIDs
      failure, TNF inhibitors can be used, like infliximab or etanercept. Before starting an
      anti-TNF treatment, a screening is mandatory. Indeed, patients treated with an anti-TNF must
      be followed regularly. Until now, there is no algorithm which can predict the response to
      TNF-inhibitors, and more especially for etanercept treatment.

      In this clinical trial, the investigators want to caracterise an algorithm which can predict
      the response to etanercept for a cohort of patients who suffer from spondyloarthritis.

      The development of a predictive algorithm for etanercept treatment will be set up from
      biological data and finalized with the availibility of clinical data (M6) of the patients .

      A modelling by logistic regression will be used, incorporing the set of available variables.

      In this clinical trial, the investigators want to caracterise an algorithm which can predict
      the response to TNF-inhibitors for a cohort of patients with Spondyloarthritis and for an
      indicated treatment of etanercept.
    

Intervention name(s): Etanercept ® 50 mg
Intervention type(s): Drug
Intervention description(s): The etanercept is not the experimental study drug. Etanercept is a treatment justifying the inclusion of patients and is used in accordance with its marketing authorization.
Other intervention name(s): ENBREL
Intervention MeSH terms: Etanercept
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: TNF inhibitor; Etanercept; Spondyloarthritis; Biomarkers analysis; Personnalized medicine
Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing
Condition: Stress Incontinence, Female; Overactive Bladder; Lower Urinary Tract Symptoms
MeSH terms: Urinary Bladder, Overactive; Urinary Incontinence, Stress; Lower Urinary Tract Symptoms
Study type: Interventional

Summary: 
      In this pilot study the investigators attempt to answer the question, does mindfulness
      exercises before urodynamic testing reduce patient's perception of anxiety or pain?
    

Detailed description: 
      The subjects are being asked to consider participation in this research study. The purpose of
      this study is to see if incorporating mindfulness exercises prior to urodynamic studies (UDS)
      results in less pain, anxiety and discomfort.

      The participants will be guided through a mindfulness meditation exercise by a licensed
      professional. During this exercise participants will be asked to focus attention on
      breathing, physical sensations, and thoughts. This exercise will last for approximately 10
      minutes in which participants will not be asked to engage in any physical activity other than
      sitting and breathing. The participants will be randomly assigned to one of 2 treatment
      plans. Randomization is a process like flipping a coin and means the chance of being assigned
      to either of the plans. One treatment plan includes undergoing mindfulness exercises prior to
      your UDS evaluation. The other treatment plan includes simply undergoing the UDS evaluation.

      After the participants UDS evaluation, questions will be asked about the urodynamic
      procedure. The participants will be asked to answer questions on a UDS and anxiety
      questionnaire which pertain to emotional and physical experiences during the procedure.
    

Intervention name(s): Mindfulness exercises
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: urodynamics
D-Cycloserine to Enhance Cognitive Behavioral Therapy (CBT) for Acrophobia
Condition: Phobic Disorders
MeSH terms: Phobic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the utility of post-session administration of
      D-cycloserine to enhance fear extinction in a sample of people with acrophobia who will be
      treated with CBT.
    


Intervention name(s): Individual Cognitive Behavioral Therapy (CBT); D-Cycloserine; Placebo
Intervention type(s): Behavioral; Drug; Drug
Intervention description(s): The aim of CBT is to help participants become more comfortable with heights situations. Participants will receive 2 sessions over two weeks of individual CBT.; D-Cycloserine; Sugar Pill
Other intervention name(s): CBT; DCS
Intervention MeSH terms: Cycloserine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phobias; Anxiety Disorders; D-Cycloserine; Phobic Disorders; Mental Disorders; Heights; Acrophobia
Comparison of the Effectiveness of the Ultrasound Guided Injections in Patients With Shoulder Impingement Syndrome
Condition: Shoulder Impingement; Ultrasound Guided Injection
MeSH terms: Shoulder Impingement Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Shoulder pain, which is the third most common cause of musculoskeletal pain, has different
      etiologies. Muscle, bone structures and connective tissue pathologies can cause shoulder
      pain. Impingement syndrome (IS), which can cover many terms such as rotator cuff disorders,
      tendinitis and tears, is one of the most common pathologies of shoulder pain.
    

Detailed description: 
      The hypothesis of this study was that injection types including ACJ would increase treatment
      efficacy.Therefore, this study investigated the six-month follow-up results of patients
      undergoing SA injection and SSNB and those receiving SA and ACJ injection.
    

Intervention name(s): bupivacaine and methylprednisolone; bupivacaine and methylprednisolone; bupivacaine and methylprednisolone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 5 mL of 0.25% bupivacaine containing 20 mg methylprednisolone was administered to the subacromial area; 5 mL of 0.25% bupivacaine containing 20 mg methylprednisolone was administered to the subacromial area for the subacromial+acromioclavicular joint injection. In addition, 2 mL of 20 mg methylprednisolone and the same concentration of local anaesthetic were injected into the acromioclavicular joint; suprascapular nerve block was administered with a mixture of 10 mL of 0.25% bupivacaine and 40 mg methylprednisolone
Other intervention name(s): suprascapular nerve block
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Bupivacaine; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective,randomized controlled, single blind
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy of Study Drug Versus Placebo for Negative Symptoms of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to determine the efficacy (how well the drug works), safety, and side effects
      of the study medication compared to placebo in the treatment of the negative symptoms of
      schizophrenia in adults.
    


Intervention name(s): R209130
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: schizophrenia with negative symptoms
Effect of a Programme Based on Professional Ethics in Physiotherapy Students
Condition: Ethics
Study type: Interventional

Summary: 
      The aim of this study was to assess the effect of a higher education programme based on
      professional ethics in physiotherapy students.

      A simple-blind clinical trial was performed. A three-months program based in professional
      ethics was carried out.

      The investigators compared a control group (traditonal lectures) with an intervention group
      (syllabus, activities, face to face techniques). Students´ attitudes, knowledge, professional
      values, and opinions towards professional ethics were evaluated before and after the
      programme, in both groups. All participants were informed about the study and procedures, and
      provided written informed consent.
    

Detailed description: 
      Participants. Second-year degree students of Physiotherapy Degree at the University, aged
      between 20 and 30 years, were recruited voluntarily from January 2019 to April 2019 . All
      enrolled participants were informed of the purpose of the study and procedures, and provided
      written informed consent. The study was carried out at the institution where the authors
      belong.

      Research design. A prospective simple-blind trial was performed. After baseline assessment,
      participants were allocated to one of the two groups (control group and experimental group).
      An external assistant not involved in the study performed assignment.

      Intervention. A Physiotherapy professor with over-10-year experience in Ethics and
      Physiotherapy performed the teaching methodology and opened the allocation envelopes and
      applied the teaching methodology to the EG according to the group assignment. The
      intervention consisted of a three-month program based in professional ethics, including two
      phases: A) syllabus and activities; and B) face to face group sessions including techniques
      such as concept maps, glossaries, brainstorming, four corners activity, aquarium, philip 6-6,
      kahoot, Realm Individual-Process Situation, reduced groups, guided debates, and discussion
      groups.
    

Intervention name(s): Experimental group
Intervention type(s): Other
Intervention description(s): Experimental group followed the 3-months programme based in professional ethics. A specific syllabus about Professional Ethics was developed. It consisted of 6 themes and included topics as moral values, ethics and moral, bioethics and professional ethics, ecc. Six related activities were created: to solve situations related to real clinical practices. Face to face group sessions based on cooperative learning were planned. Students were divided in small groups, and active participation techniques were used.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Field Randomization of Nerinetide (NA-1) Therapy in Early Responders
Condition: Acute Cerebral Ischemia
MeSH terms: Brain Ischemia; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether nerinetide (NA-1) is effective in reducing
      global disability in patients with acute cerebral ischemia if administered early after
      symptom onset.
    

Detailed description: 
      Nerinetide (NA-1) is being developed as an emergency drug aimed at reducing global disability
      in patients with acute cerebral ischemia if administered early after symptom onset.

      The primary objective is to determine the efficacy of nerinetide in reducing global
      disability in patients with acute stroke. The secondary objectives are to determine the
      efficacy of nerinetide in reducing functional dependence, reducing mortality rate, reducing
      worsening of stroke, improving neurological outcome and improving activities of daily living.

      The leading safety objectives are to determine the effect of administering a target dose of
      2.60 mg/kg (up to a maximum dose of 270 mg) IV infusion of nerinetide within three hours of
      symptom onset by paramedics in the field on serious adverse events and 90-day mortality.

      This trial is a multicenter, randomized, double-blind, placebo-controlled, single dose study
      initiated prehospital in the ambulance. It is being conducted using Emergency Medical
      Services (EMS) in Canada. Subjects with suspected acute stroke will be identified in the
      field by trained paramedics using the approved stroke protocol in use by the local EMS
      system, and further screened for eligibility and approval by an on-call trial physician. The
      paramedics will administer the study drug. Upon arrival at the emergency department, subjects
      will receive standard-of-care.

      An Independent Data Monitoring Committee will perform safety reviews of the clinical data.
    

Intervention name(s): Nerinetide (NA-1); Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Ischemia; Prehospital; NA-1; Modified Rankin Scale; Haemorrhagic stroke; Transient ischemic attack; Nerinetide
Sequential vs. Monophasic Media Impact Trial (SuMMIT)
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the impact of two FDA approved culture media on potential of human embryos
      resulting from IVF (sequential & monophasic media). Half of each patient's embryos will be
      randomly assigned to grow in monophasic media & the other half in sequential media. All
      embryos will undergo Comprehensive Chromosome Screening (CCS) & the best euploid embryo from
      each group will be transferred resulting in a double embryo transfer (DET). If there are only
      euploid embryos from one group, patient will have single embryo transfer (SET)(fresh or
      frozen).
    


Intervention name(s): Comprehensive Chromosome Screening
Intervention type(s): Other
Intervention description(s): On day 5 or 6 of embryo development, all embryos will undergo a trophectoderm biopsy using the standardized technique, as according to standard laboratory protocol and without regard to study. Comprehensive Chromosome Screening (CCS) results will be available by the morning of day 6 if embryos are suitable for a fresh transfer which is the routine in our program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Monophasic; Sequential; Media
Determining the Immediate Effects of Counterforce Bracing Versus Kinesiotaping in Patients With Tennis Elbow
Condition: Tennis Elbow
MeSH terms: Tennis Elbow
Study type: Interventional

Summary: 
      The purpose of this study was to compare the immediate efficacy of Counterforce brace versus
      kinesiotaping on patients with lateral epicondylosis/tennis elbow with respect to a
      repetitive physical task. The investigators hypothesized that there would be difference in
      the outcomes with respect to interventions and activity. Patient came for one hour long
      Single occasion testing session and were not followed up after the testing was complete.
    

Detailed description: 
      This was a cross over randomized control trial. Thirty patients with clinical diagnosis of
      lateral epicondylosis/tennis elbow were recruited from a local community and were tested on
      single occasion (one time testing session) before and after a five minute upper extremity
      repetitive task first with control and then brace and kinesiotape assigned in cross-over
      design. The testing session was one hour long and there was no follow up of patients
      following the testing. The patients were recruited between Jan-June 2013.
    

Intervention name(s): Kinesiotape; Counterforce elbow brace
Intervention type(s): Device; Device
Intervention description(s): Pre-cut kinesiotape for tennis elbow, spidertech.com, applied on wrist extensors starting above elbow and ending at distal one third of forearm; Applied over the wrist extensor muscle mass, had velcro for adjustment, comfortable grip as reported by patient was used to adjust the brace
Other intervention name(s): elastic tape, elastic therapeutic tape, kinesiotex tape; elbow strap, forearm brace, forearm strap
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tennis elbow, treatment, lateral epicondylitis, immediate effects
SCHEDULE - Scandinavian Heart Transplant Everolimus de Novo Study With Early Calcineurin Inhibitor (CNI) Avoidance
Condition: Renal Function and Chronic Allograft Vasculopathy
MeSH terms: Vascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      A controlled, randomized, open-label, multicenter study evaluating if early initiation of
      everolimus and early elimination of cyclosporine in de novo heart transplant recipients can
      improve long-term renal function and slow down the progression of chronic allograft
      vasculopathy
    

Detailed description: 
      This was a prospective, multi-center, randomized, controlled, parallel group, open label
      study in de novo heart transplant recipients. Patients eligibility for randomization was
      assessed 5 days after heart transplant.. Patients fulfilling the inclusion and exclusion
      criteria were randomized to one of two treatment groups: either conventional treatment with
      Cyclosporine A (CsA), Mycophenolate mofetil (MMF), and corticosteroids (Group A), or low-dose
      CsA and everolimus, reduced dose MMF, and corticosteroids (Group B). After 7 to 11 weeks, CsA
      was discontinued in Group B, while the standard triple-drug immunosuppressive regimen was
      maintained in Group A.
    

Intervention name(s): Cyclosporine; Mycophenolate mofetil; Corticosteroids; Everolimus; Anti Thymocyte Globulin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Cyclosporine (CsA) control group target blood level: 150-350 ng/mL (month 1-3); 100-250 ng/mL (month 4-6); 60-200 ng/mL (month 7-12); everolimus group target blood level: 75-175 ng/mL (month 1-3); Mycophenolate mofetil (MMF) target dose for control group: 2000-3000 mg/day everolimus group target dose: 1500-2000 mg/day and 75-175 ng/mL after week 11; Corticosteroids (CS) initiated at 0.2-0.5 mg/kg/day. Tapered to no less than 0.1 mg/kg at Month 3 for control and everolimus groups.; Everolimus 0.75 mg twice a day as starting dose up to a target blood level: 3-6 ng/mL (7-11 weeks) and 6-10 ng/mL for remaining of study; Induction therapy, Anti Thymocyte Globulin (ATG): 1-2 mg/kg/day during 3-5 days for control and everolimus groups after transplant surgery and prior to randomization.
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Everolimus; Cyclosporins; Antilymphocyte Serum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment