bioihbjkbjnl/mcl2 huggingface dataset:
Dose-Finding Safety and Efficacy Trial of Org 50081 (Esmirtazapine) in the Treatment of Vasomotor Symptoms (177001/P06472/MK-8265-013)
Condition: Postmenopausal Symptoms; Menopause; Vasomotor Symptoms
Study type: Interventional
Phase: Phase 3

Summary: 
      To investigate efficacy and safety of 4 doses of esmirtazapine, compared to placebo, in the
      treatment of moderate to severe hot flushes (vasomotor symptoms) associated with the
      menopause. Co-primary efficacy endpoints are the frequency and severity of hot flushes after
      4 and 12 weeks as compared to Baseline.
    

Detailed description: 
      The most direct treatment of hot flushes may be by means of 5-HT2A receptor antagonist.
      Mirtazapine is a potent blocker of 5-HT2A receptors and was found to be effective in reducing
      the number and intensity of hot flushes in preliminary trials. Also several Selective
      Serotonin Reuptake Inhibitors (SSRIs) and other similar compounds have been investigated to
      manage hot flushes, confirming the role of the serotonergic system. In the present trial, the
      efficacy and safety of four different doses of esmirtazapine compared to placebo were
      investigated in women with moderate to severe vasomotor symptoms associated with the
      menopause. The primary objective of this trial was to demonstrate superior efficacy in at
      least one of the four doses of esmirtazapine as compared to placebo on the four following
      co-primary endpoints: 1) the mean change from baseline in average daily frequency of moderate
      and severe vasomotor symptoms at Week 4; 2) the mean change from baseline in average daily
      frequency of moderate and severe vasomotor symptoms at Week 12; 3) the mean change from
      baseline in average daily severity of moderate and severe vasomotor symptoms at Week 4; 4)
      the mean change from baseline in average daily severity of moderate and severe vasomotor
      symptoms at Week 12. The number and severity of hot flushes was recorded by means of
      electronic diary by the subjects.
    

Intervention name(s): Esmirtazapine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Four different doses (2.25, 4.5, 9.0, and 18 mg) encapsulated esmirtazapine tablets in Swedish Orange hard gelatin DB-B capsules for blinding purposes. Encapsulated tablets were administered orally once daily in the evening prior to sleep for 12 weeks.; Encapsulated placebo tablets in Swedish Orange hard gelatin DB-B capsules for blinding purposes. Encapsulated tablets were administered orally once daily in the evening prior to sleep for 12 weeks.
Other intervention name(s): Esmirtazapine maleate; SCH 900265; Org 50081
Intervention MeSH terms: Mirtazapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117)
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the ability of oral montelukast/loratadine to improve the signs and
      symptoms of seasonal allergic rhinitis compared with loratadine alone, montelukast alone and
      placebo.
    


Intervention name(s): Comparator: montelukast/loratadine; Comparator: montelukast; Comparator: loratadine; Comparator: placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): montelukast 10 mg/loratadine 10 mg tablet taken once daily at bed time for 2 weeks; montelukast 10 mg tablet taken once daily at bed time for 2 weeks; loratadine 10 mg tablet taken once daily at bed time for 2 weeks; placebo tablet taken once daily at bed time for 2 weeks
Intervention MeSH terms: Loratadine; Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
CBT in Adolescents With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The effectiveness of cognitive behavioural therapy (CBT) for adolescents with type 1 diabetes
      will be tested. This structured, time-limited, problem-orientated therapy will be used to
      impact on psychosocial factors influencing diabetic control, with the patient and therapist
      working together on specific goals to develop adaptive strategies.
    

Detailed description: 
      Ninety 11-16 year olds with T1DM (duration >1 year), attending paediatric diabetes outpatient
      clinics based in 4 centres in South-West England, UK, will be recruited to a randomised
      controlled trial of one to one sessions of CBT versus non-directive supportive counselling.
      Participants will attend up to 6 sessions (weekly) with either a CBT therapist or a
      counsellor, with 2 further sessions at 6 and 12 months. Follow up will continue for 12 months
      post intervention. HbA1c is the primary outcome measure. Psychological measures will also be
      measured.
    

Intervention name(s): Cognitive Behaviour Therapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 Diabetes Mellitus; Adolescents; Cognitive Behaviour Therapy
Effects of Combined Grape Seed Extract and L-citrulline Supplementation on Hemodynamic Responses in Young Males
Condition: Dietary Supplementation
Study type: Interventional

Summary: 
      This study was to examine the additive benefits with combined grape seed extract (GSE) and
      L-citrulline supplementation on hemodynamic responses to dynamic exercise, 11 young, healthy
      males were recruited for this study.
    

Detailed description: 
      The investigators aimed the additive effects of combined grape seed extract (GSE) and
      L-citrulline supplementation on hemodynamic responses to dynamic exercise, 11 young, healthy
      males were recruited for this study. Effects of 7 days of combined GSE with L-citrulline
      supplementation on systolic blood pressure (SBP), diastolic blood pressure (DBP), mean
      arterial blood pressure (MAP), cardiac output (CO), total vascular conductance (TVC), and
      oxygen consumption (O2) were examined at rest and during cycling exercise.
    

Intervention name(s): Grape seed extract; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Effects of 7 days of combined GSE with L-citrulline supplementation on hemodynamic responses at rest and during cycling exercise.; Effects of 7 days of placebo supplementation on hemodynamic responses at rest and during cycling exercise.
Intervention MeSH terms: Grape Seed Extract
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Comparison of Functional Outcome Between BQT and SBHT ACL Reconstruction
Condition: Sports Injury; Anterior Cruciate Ligament Rupture
MeSH terms: Rupture; Athletic Injuries
Study type: Interventional

Summary: 
      ACL rupture has a high morbidity in productive-age population. The increasing incidence and
      proper management has become a point of interest in the musculoskeletal sport injury.
      Choosing the best graft has become the main focus in searching for a better outcome regarding
      ACL reconstruction in these patient population. Currently, single bundle hamstring tendon
      (SBHT) autograft was preferred in Asian population compared to bone quadriceps tendon (BQT)
      autograft. However, there are some problems such as smaller size, as well as diameter, of
      SBHT. This study is focused on evaluation of the clinical outcome between BQT and SBHT in
      arthroscopic-assisted ACL reconstruction patients.
    

Detailed description: 
      In this prospective cohort study, 30 subjects were divided into 2 groups (BQT and SBHT).
      Sampling was taken between February 2016-2017 (1 year) in one orthopaedic center. The
      instruments used for evaluation are rolimeter and PRO questionnaires (IKDC, Tegner-Lysholm,
      and KOOS) with data mining between 1 month, 3 months, and 6 months post operation.

      To obtain a valid and accountable research data, the investigators collected the information
      based on 2 parameters and then crosschecked the results.

      After clinical data was obtained, the investigators translate the results into a statistical
      data using SPSS ver.24 and simplified the data for national registry and academic purposes.

      According to previous studies, and research hypothesis, functional outcome of patient
      undergoing arthroscopic-assisted ACL reconstruction is better in BQT group compared to SBHT
      group, both in subjective and objective parameters given.
    

Intervention name(s): Bone Quadriceps Tendon (BQT) arthroscopic-assisted ACL reconstruction; Single-Bundle Hamstring Tendon (SBHT) arthroscopic-assisted ACL reconstruction
Intervention type(s): Procedure; Procedure
Intervention description(s): New intervention method deployed in Indonesia to gain better clinical outcome for ACL--deficient patients requiring surgical treatment; Comparator for New Reconstruction Technique
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: multi-site study 15 subjects on each group analysis
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ACL reconstruction; Arthroscopic-assisted; BQT; SBHT
Neoadjuvant Apalutamide (ARN509) and Radical Prostatectomy in Treatment of Intermediate to High Risk Prostate Cancer
Condition: Cancer of the Prostate
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an investigator-initiated phase II single arm trial, combining neoadjuvant
      apalutamide (ARN509) with radical prostatectomy, in the treatment of D'Amico intermediate to
      high risk organ-confined prostate cancer. Apalutamide has shown efficacy in castrate
      resistant prostate cancer in phase II studies and are now in phase III trials combined with
      radiation in organ confined disease.

      The primary study objectives include assessment of (i) oncological efficacy as determined by
      tumour downstaging and achievement of nadir PSA The secondary study objectives include(i)
      determination of adverse effects related to apalutamide and surgical complication rates (ii)
      human prostate tissue effect of apalutamide

      The study will recruit thirty eligible participants who will receive 12 weeks of oral
      apalutamide 240mg daily. This will be followed by standard-of-care radical prostatectomy. The
      total trial duration is 26 weeks.
    

Detailed description: 
      This is a phase II single arm study looking at the efficacy of 12 weeks of neoadjuvant
      apalutamide (ARN 509), combined with standard-of-care radical prostatectomy, for D'Amico
      intermediate to high risk prostate cancer patients. The phases of the study will include:
      screening, treatment and follow-up phases.

      Safety will be monitored throughout the study.
    

Intervention name(s): Apalutamide
Intervention type(s): Drug
Intervention description(s): Participants will receive oral apalutamide 240mg daily for 12 weeks
Other intervention name(s): ARN509
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prostate cancer; prostatectomy, retropubic; Androgen Receptor Antagonists
Study of Efficacy and Safety of Secukinumab in Chinese Subjects With Active PsA Compared to Placebo.
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to assess the efficacy and safety of secukinumab in Chinese
      participants with active PsA compared to placebo
    

Detailed description: 
      This study used a randomized, double-blind, placebo-controlled, parallel-group design. A
      screening period running up to 10 weeks before randomization was used to assess participant
      eligibility followed by 52 weeks of treatment. At baseline, approximately 40 Chinese patients
      will be randomized.

      A follow-up visit was done 12 weeks after last study treatment administration for all
      participants, regardless of whether they complete the entire study as planned or discontinue
      prematurely.

      The total combined duration of treatment for this Phase III study was 52 weeks. The primary
      objective was to demonstrate the treatment effect of secukinumab in Chinese subjects with
      active PsA by assessing ACR20 response rates at Week 16
    

Intervention name(s): Secukinumab (AIN457); Secukinumab Placebo
Intervention type(s): Drug; Other
Intervention description(s): Biological; Matching placebo
Other intervention name(s): Secukinumab; Placebo
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: At Baseline, the patients fulfilling the inclusion criteria were randomized to one of the following two groups.
Group 1 : Secukinumab Dose level 1 s.c. at BSL, Week 1, 2, 3, 4, 8, and 12 Group 2 : Secukinumab Placebo s.c. at BSL, Week 1, 2, 3, 4, 8, and 12.
At Week 16, the participants in Group 1 and Group 2 will be re-randomized:
Group 1: Secukinumab dose level 2 s.c. regimen and placebo OR secukinumab dose level 2 every 4 weeks from Week 16 to Week 48.
Group 2: Secukinumab dose level 2 s.c. regimen and placebo OR secukinumab dose level 2 every 4 weeks from Week 16 to Week 48.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PsA; immune-mediated chronic inflammatory disease; spondylarthritis; SpA; inflammatory musculoskeletal disease; China bridging study
The Use of Emergency Department by Syrian Refugees and the Increasing Cost of Health Care
Condition: Emergency
MeSH terms: Emergencies
Study type: Observational

Summary: 
      Since the beginning of the Syria conflict in March 2011, more than 10 million Syrians were
      forced to leave their homes and sought refuge in neighboring countries.
    

Detailed description: 
      Since the beginning of the Syria conflict in March 2011, more than 10 million Syrians were
      forced to leave their homes and sought refuge in neighboring countries (). In the result
      influx of the thousands of Syrian migrants who continue to cross into world, all the world
      especially the European countries faced with a huge refugee problem. Emergency medicine is
      play key role of being healthcare's safety net, being the last resort for those with no
      primary healthcare and no alternatives.

      The aim of this study was to evaluate the use of Emergency Department by Syrian refugees and
      total and costs of their health care.
    

Intervention name(s): Syrian Refugees
Intervention type(s): Other
Intervention description(s): Adult Syrian patients who visited the Emergency Department
Other intervention name(s): Syrian Refugee patient
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        adult Syrian patients who visited the Emergency Department of Adiyaman University of
        Training and Research Hospital between 1 January 2015 and 1 January 2016 retrospectively.
      
Keywords: refugees; Syrian; cost; visit
Safety and Pharmacokinetic Study of Hepalatide(L47) in Healthy Volunteers
Condition: Hepatitis B， Chronic
MeSH terms: Hepatitis B; Hepatitis B, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of Hepalatide(L47) and characterize the clinical
      pharmacokinetics in healthy volunteers.
    

Detailed description: 
      This is a randomized, double-blinded, dose escalating, phase Ia trial, which will be
      conducted in No. 302 Hospital of China. There are seven cohorts at dose of 0.21mg, 0.525mg,
      2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg. The first cohort with 0.21mg is an open test with no
      placebo as control. All other healthy volunteers will be randomized into Hepalatide or
      placebo group at 4:1 rate, and will be received drug by abdominal subcutaneous injection and
      will be observed for 8 days.
    

Intervention name(s): Hepalatide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): There are seven cohorts as follows 0.21mg, 0.525mg, 2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg. Dose of 0.21mg is a pilot trial with no placebo. At each dose level, healthy volunteers will be received treatment drug by abdominal subcutaneous injection at the first day and monitored for 8 days.; There are six cohorts as follows 0.525mg, 2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg. At each dose level, healthy volunteers will be received control drug by abdominal subcutaneous injection at the first day and monitored for 8 days.
Other intervention name(s): treatment drug; control drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Impact of MOHO on Therapists Working With Clients in Cancer Population
Condition: Cancer
Study type: Observational

Summary: 
      The purpose of this study is to examine the impact of an introduction to the occupation-based
      theory (MOHO) on the clinical reasoning of therapists working with cancer clients.
    

Detailed description: 
      The study will occur at MDACC, a comprehensive cancer center in the Texas Medical Center
      (TMC) in Houston. The center is the largest freestanding comprehensive cancer center in the
      world. The facility provides inpatient and outpatient services and supports research and
      education.

      The facility has more than 50 buildings in the greater Houston area and in central Texas. The
      setting for this study will be the rehabilitation services area on the main campus in the
      TMC.

      There are private offices, conference rooms and treatment areas where video chats and monthly
      meetings will occur.

      The study is projected to occur over a one year period. Sessions will be videotaped (video
      chats - initial and follow ups and monthly group meetings) for further review. Analysis of
      the tapes will provide data for further research and education presentations. Sessions will
      also be audiotaped and transcribed for further review and data analysis purposes. Neither the
      videotapes nor audiotapes will be shared with anyone at the facility or any uninvolved
      parties. Audiotapes and videotapes will be stored in locked file cabinets and password
      protected computers will be used to view and analyze the audio and video tapes. Only the
      research team will have access to the stored data locked in the file cabinet.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will be outpatient-focused therapists working within the MD Anderson Cancer
        Center. Participants must have worked in this setting for at least 90 days before the study
        begins and will self-select to participate in the study. Recruitment of therapists at the
        MDACC will involve an introduction of the study by an onsite collaborator. The onsite
        collaborator will gather the names of individuals interested in participating in the study.
        Then, an onsite collaborator and PI will work together to determine if the therapists meet
        the inclusion criteria for the study. Once the therapists are determined to meet inclusion
        criteria, an invitation for participation will be extended by an onsite collaborator.
      
Keywords: MDACC; MOHO
A Study Of Milnacipran In Patients With Fibromyalgia: Effects On 24 Hour Ambulatory Blood Pressure Monitoring
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is designed to accurately assess any changes in blood pressure and pulse at 100 and
      200 mg daily dose of milnacipran in patients with fibromyalgia syndrome.
    

Detailed description: 
      This study is double blind (neither you nor the physician will know if you are receiving
      active study drug or placebo, an inactive compound such as a sugar pill) and it is being
      conducted at various research centers in the United States.

      If the study staff determines that you are eligible and you decide to participate, there will
      be approximately 11 study visits in about 3 months. During these visits, you will undergo
      routine health exams and complete different kinds of questionnaires.

      This study requires that you wear a blood pressure cuff continuously for 24 hours on three
      separate occasions. You will also be required to make multiple same-day visits to the study
      site on three separate occasions for blood draws.
    

Intervention name(s): Milnacipran hydrochloride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Milnacipran 100 to 200 mg/day tablet (administered in divided doses, twice daily [BID]), oral administration.; Placebo
Other intervention name(s): Ixel (outside of United States)
Intervention MeSH terms: Milnacipran; Levomilnacipran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: NSRI; milnacipran; fibromyalgia; blood pressure; hypertension
The Effect of Ischaemic-Reperfusion and Ischaemic Preconditioning on the Endogenous Fibrinolysis in Man
Condition: Ischaemic Heart Diseases
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease; Ischemia
Study type: Interventional

Summary: 
      Heart attacks are usually caused by a blood clot blocking an artery supplying blood to the
      heart. Current treatments are designed at relieving this blockage as quickly as possible to
      minimise damage to the heart muscle. However in restoring the supply of blood local damage
      known as "ischaemia-reperfusion injury" may occur. The aim of this study is to assess how
      clot forming and clot dissolving pathways are affected during this process, and examine the
      role of a natural inflammatory hormone, bradykinin. This will help us to understand the
      mechanism by which ischaemia-reperfusion injury may occur and to devise new treatments for
      heart attacks.
    


Intervention name(s): Forearm vascular study
Intervention type(s): Procedure
Intervention description(s): Forearm blood flow measured by venous occlusion plethysmography during interarterial infusion of substance P (2,4,8 pmol/min). Venous blood sampling via cannula in antecubital fossa.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Ischaemia reperfusion; t-PA; Fibrinolysis; Endothelial function; Local and remote ischaemic preconditioning