bioihbjkbjnl/mcl2 huggingface dataset:
Endometrial Safety Study of Transdermal Testosterone (300 Mcg/Day) in Naturally Postmenopausal Women
Condition: Hypoactive Sexual Desire Disorder
MeSH terms: Hypokinesia; Sexual Dysfunctions, Psychological
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate the endometrial safety of a testosterone patch as
      treatment for low libido in naturally postmenopausal women.
    

Detailed description: 
      Naturally postmenopausal women with hypoactive sexual desire disorder (HSDD) will be
      randomized into a 52-week, multicenter, double-blind (DB), parallel-group, placebo-controlled
      study. Patients will be stratified based on whether they use concomitant estrogen/progestin
      therapy and then randomized in a 4:1 ration to receive either testosterone transdermal system
      (300 mcg/day) or placebo. Patients using estrogen/progestin at the start of the study should
      maintain this therapy throughout the study; patients not using estrogen/progestin at the
      start of the study should not initiate estrogen/progestin therapy throughout the study.
      Endometrial biopsies and transvaginal ultrasounds will be collected/performed at screening
      and study exit for all patients. Safety will be assessed by adverse events, reports of
      vaginal bleeding, lipids, serum chemistry, and hematology. Physical exams, pap smears, and
      mammograms will be monitored.
    

Intervention name(s): Testosterone Transdermal System; Placebo patch
Intervention type(s): Drug; Drug
Intervention description(s): Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks; placebo patch, changed twice a week for 52 weeks
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Natural Menopause
Treatment of Knee Osteoarthritis: Neuromuscular Electrical Stimulation and Low-level Laser.
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      -  The purpose of this study is to determine the effects of low-level laser therapy in
           combination with neuromuscular electrical stimulation on neuromuscular (muscular
           strength and morphology) and functional parameters (pain and functional tests) in
           elderly with knee osteoarthritis.

        -  The hypothesis is that the association of low-level laser therapy with neuromuscular
           electrical stimulation could reduce joint pain associated with the inflammation and
           consequently potentiates the effects of electrical stimulation on the muscular system.
    

Detailed description: 
      -  Participants was randomized into one of three intervention groups (intervention period =
           8 weeks after a 4 weeks control period in all groups).

        -  Electrical stimulation group (18-32 min of pulsed current, stimulation frequency of 80Hz
           (Hertz), pulse duration of 200μs and stimulation intensity fixed near to maximal
           tolerated),

        -  Laser group (low-level laser therapy dose of 4-6J (Joules) per point, six points at the
           knee joint)

        -  Combined group (electrical stimulation and low-level laser therapy).
    

Intervention name(s): Laser Therapy; Electrical Stimulation
Intervention type(s): Other; Other
Intervention description(s): Low-level laser therapy was administered twice a week with a minimum of 48h between sessions over a period of eight weeks.; Neuromuscular electrical stimulation was administered twice a week with a minimum of 48h between sessions over a period of eight weeks and with progressive intensity and volume.
Other intervention name(s): Low-Level Laser Therapy; Lasertherapy; Light therapy; Phototherapy; electrotherapy; electrical stimulation therapy; neuromuscular electrical stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: neuromuscular electrical stimulation; low-level laser therapy; knee osteoarthritis; muscle architecture; functionality; neuromuscular parameters
Platelet Function in Resuscitated Patients-2
Condition: Acute Myocardial Infarction; Cardiac Arrest
MeSH terms: Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      Approx. 65% of resuscitated patients at the intensive care unit for internal medicine are due
      to myocardial infarction. Almost all patients are initially diagnosed and treated in the cath
      lab. Therapy usually consists of one or more stent implantations. After implantation of a
      coronary stent, dual platelet inhibition is necessary for 12 months. Insufficient platelet
      inhibition causes an pronounced increase in risk of stent thrombosis. Therefore, secured
      inhibition and knowledge of the individual platelet function is valuable.
    

Detailed description: 
      Patients after successful resuscitation associated to a myocardial infarction will be
      included into the study the morning after the index event. Patients get dual platelet
      inhibition using cangrelor as P2Y12 (purinergic G protein-coupled receptors-12) inhibitor
      plus acetylsalicylic acid (ASS). Patients are treated with therapeutic hypothermia according
      to the local Standard operating procedure for 24h and rewarming is performed within an
      additional 5 to 20h. Platelet function is measured every morning and ASS mediated as well as
      P2Y12 mediated platelet function inhibition is recorded. All relevant clinical data including
      APACHE (Acute Physiology and Chronic Health Evaluation) and SOFA (Sequential Organ Failure
      Assessment score) scores are collected.

      The degree of platelet inhibition over time (4 days) and differences between the three drugs
      tested will be evaluated by optical aggregometry and by using the commercial VerifyNow test
      system.
    

Intervention name(s): diagnostic test of platelet function
Intervention type(s): Diagnostic Test
Intervention description(s): Light transmittance aggregometry and VerifyNow
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All patients surviving the first night after resuscitation due to myocardial infarction
Positron Emission Tomography in Rheumatoid Arthritis With Adalimumab (PETRA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      Biologics are routinely used for the treatment of rheumatoid arthritis (RA). Adalimumab is a
      human monoclonal antibody that inhibit the Tumor Necrosis Factor alpha (TNF-alpha).
      Identification of RA patients who respond to biologics is a challenging goal to avoid
      unnecessarily, costly and potentially harmful treatment.

      The aim of the study is to address if 18 F FDG is a valuable biomarker for the assessment of
      the clinical response in RA with TNF-alpha blocking agent. Eight patients fulfilling the ACR
      (American College of Rheumatology) criteria will by enrolled. Patient will receive adalimumab
      according to the current guidelines i.e. 40mg /14 days sub cutaneously. The decision will
      stand on a high activity of the disease defined by the DAS 28 (Disease Activity Score) above
      5.1. Positron emission tomography will be performed before, 2 and 12 weeks after the begin of
      the treatment. The response to adalimumab will by assessed by the SUV (standard Unit value)
      measured on the inflammatory joints of hands, wrist, ankle, feet and knees and compared to
      measurement of clinical (total swollen and tender joints count) echographic (synovium
      thickness and power doppler) and chemical biomarkers (erythrocyte sedimentation rate, C
      reactive protein).
    


Intervention name(s): adalimumab
Intervention type(s): Drug
Intervention MeSH terms: Adalimumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rheumatoid arthritis; Positron emission tomodensitometry; Tumor necrosis factor alpha inhibitor
Multimodal Music Therapy for Children With Anxiety Disorders
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Multimodal music therapy (MT) for children ages 8 to 12 years with anxiety disorders is
      compared to community treatment as usual (TAU). 36 children were randomized either to MT or
      to TAU. Primary outcome is presence of an anxiety disorder at the end of treatment. Secondary
      outcomes are self- and parent-/teacher reported anxiety, co-morbid psychological symptoms,
      and quality of life. Stability of outcome is assessed six months after the end of treatment.
    

Detailed description: 
      Patients were enrolled in a community clinic and in an outpatient clinic for child and
      adolescent psychiatry/psychotherapy. Inclusion criteria: diagnosis of an anxiety disorder
      (separation anxiety disorder, general anxiety disorder, social phobia, specific phobia, or
      other anxiety disorder); age 8-12; no medication or stable medication during treatment;
      IQ>80; informed consent of caregivers and informed assent of patients. Outcome measures.
      Kiddie-SADS; STAIC-C, SPAIC, CDI; SDQ teacher report; CBCL 4-18; ILK quality of life
      inventory. Assessment time points: pre-intervention; post-intervention; 6-months follow-up.
    

Intervention name(s): Multimodal music therapy; Community treatment as usual
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: music therapy; multimodal psychotherapy; children; anxiety disorders; pediatric anxiety
Effect of Wholegrain Wheat on Body Weight and Composition and Cardiovascular Risk
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The aim of this study is to investigate the potential beneficial effect of wholegrain on body
      weight and composition as well as cardiovascular risk in overweight women.
    

Detailed description: 
      Objective: To study the effect of the 'wholegrain concept', i.e. high intake of wheat
      wholegrain (WW) vs. refined wheat (RW) grain products on body weight and composition.

      Design: In this open-labeled randomized trial, 72 postmenopausal women with metabolic
      syndrome features were prescribed a mild calorie-restricted diet with a deficit of
      ~1,250kJ/d. Following 2 weeks run-in period on RW products, they were randomized to 12 weeks
      intervention with RW or WW products providing 2,000kJ/d.
    

Intervention name(s): wholegrain; refined wheat
Intervention type(s): Other; Other
Intervention description(s): wholegrain wheat vs. refined wheat products; refined wheat products
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; wholegrain; wheat; cardiovascular disease
Bioequivalence Study of Idalopirdine Tablets 60 mg
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to establish bioequivalence between two tablet formulations of idalopirdine
    


Intervention name(s): Idalopirdine 60 mg formulation A (test); Idalopirdine 60 mg formulation B (reference)
Intervention type(s): Drug; Drug
Intervention description(s): Tablet for oral use, single dose; Tablet for oral use, single dose
Other intervention name(s): Lu AE58054; Lu AE58054
Intervention MeSH terms: (2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Randomized Controlled Trial About Teaching Parents How to Manage Childhood Immunization Pain
Condition: Mothers of Newborn Infants
Study type: Interventional
Phase: Phase 3

Summary: 
      There is no effect of a parent-directed fact sheet about pain management during childhood
      immunization and pre-test on parent learning about evidence-based pain relieving methods.
    

Detailed description: 
      Over 90% of young children demonstrate severe distress during vaccination. Pain relieving
      strategies are uncommonly used, despite a plethora of evidence for physical, pharmacological
      and psychological techniques. Parents commonly report pain as a harm-related concern for
      childhood immunizations and are dissatisfied with current practices. Unmitigated pain causes
      long-term adverse sequelae, including; anticipatory fear and hypersensitivity to pain at
      future procedures in children, and parental non-compliance with immunization schedules.
      Health providers and parents report the major barrier to routine use of pain management is
      parental lack of knowledge about effective strategies. Lack of time is reported as a
      secondary barrier. An educational tool about immunization pain management targeted to parents
      that can be practically implemented in the clinical setting within usual time constraints is
      needed.
    

Intervention name(s): Fact sheet
Intervention type(s): Behavioral
Intervention description(s): fact sheet about pain management during immunization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: randomized controlled trial; parent education; pain management; infant; immunization
Study of Escitalopram in the Treatment of Specific Phobia
Condition: Phobic Disorders
MeSH terms: Phobic Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This pilot study is designed to assess the efficacy of escitalopram in the treatment of
      specific phobia in adult outpatients.
    

Detailed description: 
      This double-blind placebo-controlled pilot trial study is designed to assess the efficacy of
      12 weeks of escitalopram vs. placebo in the treatment of specific phobia in adult
      outpatients. It is hypothesized that escitalopram is safe and effective in the treatment of
      specific phobia.
    

Intervention name(s): Escitalopram
Intervention type(s): Drug
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: specific phobia; anxiety; SSRI; clinical trial; escitalopram
A Single-Center, Clinical Study to Evaluate the Safety of a Fragranced Personal Lubricant in Healthy Female Subjects
Condition: Erythema; Edema
MeSH terms: Erythema
Study type: Interventional

Summary: 
      To evaluate the safety of Miami w/ frag Personal lubricant when used as indicated as a
      personal lubricant in the vagina and vulvar/perineal areas at least four times weekly for two
      weeks in a population of healthy females.
    


Intervention name(s): Miami w/ frag Personal lubricant
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Prasugrel 5mg Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Aged ≥75 Years and/or Weighing <60 kg Post Percutaneous Coronary Intervention (PCI)
Condition: Platelet Reactivity
MeSH terms: Body Weight
Study type: Interventional
Phase: Phase 4

Summary: 
      The use of dual antiplatelet therapy is considered standard of care in patients post
      percutaneous coronary intervention (PCI) with stenting. However, a significant proportion of
      patients is considered clopidogrel resistant and this resistance is shown to be accompanied
      by future adverse events. The aim of the study is to define in consecutive patients with
      acute coronary syndrome (ACS) undergoing PCI, those aged>75years and/or weighted<60 Kg with
      high on-clopidogrel platelet reactivity (Platelet Reactivity Units-PRU≥235) as estimated 24
      hours post PCI with the VerifyNow assay. Those patients will be randomized after informed
      concent in 1:1 fashion to prasugrel 5 mg or clopidogrel 150mg daily. Platelet reactivity will
      be assessed at day 15 and then treatment crossover will be performed. At day 30 platelet
      reactivity will be determined as well.
    


Intervention name(s): Clopidogrel; Prasugrel
Intervention type(s): Drug; Drug
Intervention description(s): Clopidogrel 150mg per day for 15 days; Prasugrel 5mg per day for 15 days
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Platelet reactivity; Clopidogrel; Prasugrel
The Optimal Oblique and Axial Angle of Fluoroscope for Superior Hypogastric Plexus Block
Condition: Chronic Pelvic Pain; Pelvic Malignancy; Superior Hypogastric Plexus Block
MeSH terms: Neoplasms; Pelvic Pain
Study type: Observational

Summary: 
      The recommended entry angle for superior hypogastric plexus block is different among
      references, and there is a need for suggesting a more accurate entry angle for this
      procedure. The investigators are trying to evaluate the entry angle for superior hypogastric
      plexus block by measuring these angle on the computed tomography image and apply these angle
      to the real patients.
    

Detailed description: 
      Superior hypogastric plexus block is a kind of sympathetic plexus block which are used to
      control the pelvic pain caused by malignancy or other chronic condition. Classic posterior
      approach for this procedure is inserting the block needle at L4 -5 level and proceed the
      needle 45 degrees medially and 30 degrees caudally to reach the target of anterolateral space
      of L5 - S1 intervertebral space. Waldman et al. introduced a different angle of 30 degrees
      medial and caudal with the same approach, while Stevens et al. recommended 15 degrees medial
      and 20 degrees caudal. As such, the recommended angle for this procedure is different among
      references, and there is a need for suggesting a more accurate entry angle for this
      procedure. Therefore, we are trying to evaluate the entry angle for superior hypogastric
      plexus block by measuring these angle on the computed tomography image and apply these angle
      to the real patients.
    

Observational model: Case-Control
Sampling method: Non-Probability Sample
Study population: 
        Those undergoing abdominopelvic CT scan with pelvic malignancy or chronic pelvic pain with
        constitutional disease
      
Keywords: superior hypogastric plexus block; pelvic malignancy; chronic pelvic pain
Lateral Sagittal vs Costoclavicular Brachial Plexus Block in Children
Condition: Hand Injuries and Disorders; Forearm Injuries
MeSH terms: Wounds and Injuries; Hand Injuries; Forearm Injuries
Study type: Interventional

Summary: 
      Costoclavicular approach has lots of advantages compared to the lateral sagittal approach for
      infraclavicular brachial plexus block. Although the efficacy of this block has been
      demonstrated in adults, there are no randomized controlled trials in the literature on the
      application of pediatric patients. Our aim was to compare the ultrasound-guided
      infraclavicular and costoclavicular approach in pediatric patients.
    


Intervention name(s): Lidocaine and Bupivacaine solution; Costoclavicular block; Lateral Sagittal block
Intervention type(s): Drug; Device; Device
Intervention description(s): 1:1 ratio 2% lidocaine, and 0.5% bupivacaine; Ultrasound-guided costoclavicular brachial plexus block; Ultrasound-guided lateral sagittal brachial plexus block
Intervention MeSH terms: Lidocaine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile Spasms
Condition: Infantile Spasms
MeSH terms: Muscle Cramp; Spasm; Spasms, Infantile
Study type: Interventional
Phase: Phase 2

Summary: 
      The study consists of cohorts where participants are randomized, in a 2:1 ratio, to 1 of 2
      sequences, A and B. In each cohort, Sequence A, comprised of participants, who will receive
      ascending doses of ganaxolone and ascending doses of placebo. Sequence B, comprised of
      participants, who will receive ascending doses of placebo and ascending doses of ganaxolone.
      The dosing level in each subsequent cohort will be based upon experience gained from previous
      cohorts.
    

Detailed description: 
      Male or female, 4 to 24 months of age (inclusive) with a diagnosis of IS with a 24 hour video
      EEG (vEEG) recording confirming the diagnosis and previously treated with 3 or fewer
      antiepileptic drugs (AEDs) are eligible for the study. The subject is able to continue
      treatment with concomitant AEDs (no more than 2; adrenocorticotropic hormone [ACTH],
      corticosteroids, felbamate, and vigabatrin are not allowed concomitantly). A ketogenic diet
      is permitted if it can be maintained for the duration of the study.

      There will be a total of three weekly 24-hr video EEGs (baseline, end of weeks 1 and 2 of
      treatment). Dosing titration begins the day after each video EEG during the inpatient stay.
      All subjects will be receiving ganaxolone the day after the second video EEG.

      A Data Monitoring Board (DMB) will determine whether successive cohorts of subjects can be
      dosed at an increased dose level; up to a maximum of 6 cohorts.
    

Intervention name(s): Ganaxolone; Placebo
Intervention type(s): Drug; Other
Intervention MeSH terms: Ganaxolone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: infantile spasms; anticonvulsant; pediatric epilepsy; West Syndrome; epileptic spasms
Safety, Tolerability and Immunogenicity of Two Different Formulations of an Influenza A Vaccine (FP-01.1)
Condition: Influenza A
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This study has been designed to evaluate the safety and immunogenicity of two different
      formulations of FP-01.1 as well as build on the data set from the first in human study
      FP-01.1_CS_01. It is anticipated that the results of this Phase I study will inform the best
      formulation of the vaccine to evaluate in efficacy studies.
    


Intervention name(s): FP-01.1; FP-01.1-Adjuvant
Intervention type(s): Biological; Biological
Intervention description(s): IM injection; IM injection
Other intervention name(s): Flunisyn; Flunisyn + Adjuvant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Influenza A
Evaluation of Photosafety of BI 730357 Compared to Placebo and the Known Photosensitizing Agent Ciprofloxacin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the photosensitivity potential of BI 730357
    


Intervention name(s): BI 730357; Placebo to match BI 730357; Ciprofloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Film-coated tablet; Film-coated tablet; Film-coated tablet
Intervention MeSH terms: Ciprofloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment