bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Find Out How Much Mirabegron Gets Into the Body After Dosing With a Tablet Formulation
Condition: Pharmacokinetics of Mirabegron; Bioavailability; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to evaluate how much of the active compound of mirabegron comes into the blood
      circulation when given as a controlled-release pill as compared to given intravenously.
    

Detailed description: 
      All participants will receive both oral and iv formulations, separated by a washout period.
      Treatment arm A will receive a lower dose of mirabegron; Treatment arm B will receive a
      higher dose of mirabegron.
    

Intervention name(s): mirabegron OCAS; mirabegron
Intervention type(s): Drug; Drug
Intervention description(s): oral administration; iv administration
Other intervention name(s): YM178 OCAS; YM178
Intervention MeSH terms: Mirabegron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Pharmacokinetics; Mirabegron; Phase 1
Zinc and Biobehavioral Development in Early Childhood
Condition: Child Development
Study type: Interventional

Summary: 
      Zinc is necessary for growth and development, including the central nervous system, and zinc
      deficiency which is common in resource-poor settings, may adversely affect social,
      behavorial, cognitive and sensorimotor development. The project, located in Lima Peru,
      utilizes an experimental model in which children receive 10 mg supplemental zinc (or not)
      daily along with 10 mg iron and 1/2 mg copper from 6 months of age to 18 months of age.
      Beginning at 6 months of age, and at 9, 12, and 18 months, children are evaluated in
      multiples aspects of development. Children are also followed for their diet, growth, and
      health status. We hypothesize that children in this setting in which the diet is low in zinc
      who receive supplemental zinc will have better information processing skills, sensorimotor
      and behavioral development than their counterparts who do not receive supplemental zinc.
    


Intervention name(s): zinc; iron + copper
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 10 mg elemental zinc + 10 mg elemental iron + 0.5 mg copper syrup taken daily for 1 year, from 6 to 18 months of age; 10 mg elemental iron + 0.5 mg copper in syrup given daily for one year from 6 months to 18 months of age
Intervention MeSH terms: Copper
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: zinc; iron; child development; visual attention; Peru
Concussion Prevention in Female Soccer Athletes
Condition: Concussion, Mild; Concussion, Brain
MeSH terms: Brain Concussion
Study type: Interventional

Summary: 
      The purpose of the study is to monitor longitudinal changes in brain structure and function
      between the preseason and postseason, in a population of soccer playing athletes wearing the
      Device and compared to a similar population not wearing the device. Secondly, the purpose is
      to determine the protection of the device relative to amount and magnitude of sustained head
      impacts.
    

Detailed description: 
      This study will investigate the effectiveness of this device in high school athletes playing
      a non-helmeted sport such as soccer. Athletes participating in this study will be randomly
      assigned to one of two groups: 1) Device wearing during the season or 2) Non-device wearing
      during the season. This study will focus on the use and effectiveness of the device solely in
      females, as male football and hockey players have previously been investigated. All
      participants will be outfitted with an adhesive patch-like accelerometer (which will be
      placed behind the ear (Xpatch-X2 Biosystems http://www.x2biosystems.com/x2_x_patch/) which
      will measure the magnitude of every impact to the head sustained by the athlete.
      Effectiveness of the device will be determined via differences in longitudinal brain imaging
      and functional testing following competitive soccer participation. A subset of athletes who
      report a diagnosed concussion will also receive additional brain neuroanatomical and
      neurophysiological testing within a week following the diagnosed concussive event. At each of
      these time points participants will also undergo various neurocognitive assessments
    

Intervention name(s): Q Collar
Intervention type(s): Device
Intervention description(s): Collar designed to mitigate slosh in the brain
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Young Adult Influenza Vaccine Immunogenicity Substudy
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      This is a complimentary study to an elderly influenza study. Subjects 18-40 will receive a
      single dose flu vaccine and be evaluated for humoral and cell mediated immunity to influenza
      antigens.
    

Detailed description: 
      The goals of this study are to provide in depth humoral and cellular immune responses to the
      standard-dose trivalent SV influenza virus vaccine containing 15 pg HA of each virus strain
      in healthy young adults. Serum samples will be submitted for the following analysis:
      measurement of serum anti-HA (hemagglutinin) IgG and IgA antibodies by ELISA, IgG antibody
      subclasses, IgG and IgA Avidity, Virus neutralizing functional assay, HAI antibody titer.
      Peripheral blood mononuclear cells (PBMC) isolated from these subjects will be evaluated for
      the following: "central" (TCM) and "effector" (TEM) memory T cell responses, including their
      proliferative responses and cytokine production profiles by flow cytometry, IFN-7 production
      by ELISPOT, following specific antigenic stimulation. Serum samples will be submitted for the
      following analysis: measurement ex vivo of the frequency of circulating influenza-specificT
      cells by using commercially available MHC/tetramers and/or MHC/pentamers and flow cytometry,
      role of regulatory T cells in the modulation of influenza responses in young adults. Fifteen
      healthy young adult subjects, age 18-40 years, inclusive, will be recruited from the general
      population to be enrolled in this study. No randomization or masking procedures will be used.
      All eligible subjects will be administered one intramuscular (IM) injection of the same FDA
      approved standard-dose (15 mcg HA per strain) trivalent inactivated influenza vaccine,
      2004-2005 season, and key humoral and cell-mediated immunity (CMI) responses will be compared
      to those of elderly subjects enrolled under DMID 05-0028. On both Day 0 (pre-vaccination) and
      day 28 (post-vaccination), an 100 ml volume of whole blood will be obtained for a complete
      blood count (CBC) with differential and to isolate and cryopreserve serum and PBMCs. This
      study will evaluate key humoral and cell-mediated immunity (CMI) responses in healthy young
      adults to establish a baseline immune response which will be used to evaluate changes
      associated with immunosenescence. This study is linked to DMID protocol 05-0028.
    

Intervention name(s): Fluzone®
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza, sub-study
Pharmacokinetic Study of Ondansetron Administered as IR (Zofran) and MR (EUR1025)
Condition: Nausea
MeSH terms: Nausea
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to assess blood levels of ondansetron (EUR1025 24 mg) dose and
      Zofran 8 mg dose after single and multiple doses are given when taken with a meal and taken
      on an empty stomach.
    

Detailed description: 
      The objective of this study is to evaluate the pharmacokinetics (PK) of ondansetron
      administered as a novel modified-release formulation (EUR1025 24 mg) as well as the
      immediate-release formulation (Zofran 8 mg) after single and multiple oral dose
      administration under fasting and fed conditions based on the requirements of the respective
      indications. The safety profile of each treatment will also be assessed by recording the
      nature, severity, frequency, duration and relation to the treatment of any adverse events.
    

Intervention name(s): EUR-1025; EUR-1025; EUR-1025; EUR-1025
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): orally, 24 mg, daily for 6 days; orally, 8 mg, twice daily over 6 consecutive days; orally, 8 mg, three times a day over 6 consecutive days; orally, 8 mg, 16 mg, 24 mg, daily, for 6 days
Other intervention name(s): Ondansetron; Ondansetron; Ondansetron; Ondansetron
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ondansetron, EUR-1025
Efficacy and Safety Study of MP-435 in Combination With Methotrexate (MTX) in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the Efficacy, Safety, and Pharmacokinetics of
      MP-435 administered for 12 weeks in subjects with rheumatoid arthritis (RA) on stable doses
      of Methotrexate.
    


Intervention name(s): MP-435(dose1) + Methotrexate; Placebo + Methotrexate
Intervention type(s): Drug; Drug
Intervention description(s): MP-435 dose1 + stable weekly dose of Methotrexate; Placebo + stable weekly dose of Methotrexate
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis
Efficacy and Safety of Lymphdiaral Basistropfen (HDC) in the Treatment of Chronic Low-back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate superiority of HDC in comparison to placebo in the treatment of chronic low-back
      pain in relation to pain, functional impairment, quality of life, and state of health during
      a 15-week treatment period.
    

Detailed description: 
      Low-back pain is often provoked by inflammatory edema in the region of the facet joints. In
      naturopathy, a fixed homeopathic drug combination (HDC) is established in the treatment of
      edema and swellings. For the first time, the efficacy of HDC was investigated in the
      treatment of low-back pain.

      Objective: To examine the efficacy and safety of HDC medication vs. placebo in the treatment
      of chronic low back pain considering constitution and diathesism in a double-blind,
      randomized controlled clinical trial.
    

Intervention name(s): HDC; Placebo solution
Intervention type(s): Drug; Drug
Intervention description(s): (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X),10 drops t.i.d. for 15 weeks.; 10 drops, t.i.d, 15 weeks
Other intervention name(s): Lymphdiaral Basistropfen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: low-back; pain; chronic; constitution; diathesism; homoeopathy; fixed combination; herbal preparation; chronic low back pain lasting more than 6 months
DHEA Against Vaginal Atrophy - 3-Month Efficacy Study
Condition: Vaginal Atrophy
MeSH terms: Atrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this Phase III trial is to confirm the efficacy of intravaginal
      dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.
    


Intervention name(s): Placebo; DHEA; DHEA
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo vaginal suppository; Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.; Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
Other intervention name(s): Prasterone, Dehydroepiandrosterone; Prasterone, Dehydroepiandrosterone
Intervention MeSH terms: Dehydroepiandrosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vulvar/vaginal atrophy; Atrophic Vaginitis; Dehydroepiandrosterone; DHEA; Prasterone; Vaginorm; Menopause; Intrarosa
The Right Intervention for the Right Patient
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Complicated and expensive interventions are used to treat unspecific low back pain and the
      intervention is not always targeted the patients specific problems.It is therefore not
      surprising that a large fraction of unspecific low back pain patients do not respond very
      well to the usual biopsychosocial intervention.

      We would therefore like to identify the patients specific problems regarding the patients
      biomedical, psychological, and social needs.
    

Detailed description: 
      Two quality assurance investigations are performed in the The Back Research Center Clinic,
      where one is published in The Spine. The systematics of Health Technology Assessment was used
      to throw light on important indicators in relation to Health Technology aspects, patient
      aspects, organisational aspects and economical aspects. At 12 months follow up in 1999,
      approximately one third of the patients stated that their low back pain was unchanged or
      worse. In 2004 in a new investigation this fraction was larger. Therefore it seems relevant
      to be able to identify the patients early in their course in the back ambulatory.

      A Norwegian project has shown that when one divides the patients into 3 levels of severity,
      then the interdisciplinary biopsychosocial intervention had best effect in the intermediary
      and severe groups. Conversely the mono disciplinary intervention had best effect on the least
      severe patient group.

      Therefore we would like to combine elements from the typical clinical investigation with a
      screening for psychosocial factors in order to sort patients according to their individual
      needs.

      Even though the bio-psycho-social elements are a coherent continuum one can arbitrarily
      combine them in 4 groups of increasing complexity.

        -  mainly biological

        -  both biological and psychological

        -  both biological and social

        -  both biological, psychological and social It is probably not good enough to give more or
           less the same type of somatic treatment to all unspecific low back pain patients. It is
           important to take into account all three elements, the severity of the elements, and the
           combination of elements. To be able to do this it is important to use a combination of
           screening instruments that can isolate and quantify the manifestations of the three
           elements in the patients.
    

Intervention name(s): Biopsychosocial intervention
Intervention type(s): Procedure
Intervention description(s): Psychosocial versus usual care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Low back pain; Return to work; Biopsychosocial; Screening; SMS; Non specific low back pain
BMD Alterations and Bone and Muscle Parameters During Menstrual Cessation With GnRH
Condition: Endometriosis; Bone Density; Muscle; Bone Metabolism
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      The investigators aim to investigate the effect of menstrual cessation in women with
      endometriosis treated with GnRH analogs for 6 months on bone mineral density and bone and
      muscle metabolism parameters and subsequently the effects of menstrual restoration after GnRH
      analogs discontinuation on the above measured parameters
    

Detailed description: 
      Prospective, open-label, controlled 12month observational study

      Premenopausal women with surgically verified endometriosis will receive goserelin 1 injection
      per month for 6 months. Subsequently goserelin will be discontinued and patients will be
      monitored for another 6 months after menstrual restoration. Age- and BMI-matched
      premenopausal, health women will serve as controls. Controls will receive no treatment.
    

Intervention name(s): Goserelin Acetate
Intervention type(s): Drug
Intervention description(s): Goserelin the a GnRH analog that will be administered to achieve menstrual cessation for 6 months
Other intervention name(s): GnRH analog
Intervention MeSH terms: Goserelin
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Premenopausal women with surgically verified endometriosis will receive goserelin 1
        injection per month for 6 months. Subsequently goserelin will be discontinued and patients
        will be monitored for another 6 months after menstrual restoration. Age- and BMI-matched
        premenopausal, health women will serve as controls
      
Biospecimen description: 
      serum samples
    
Keywords: endometriosis; bone mineral density; myokines; sclerotin; periostin
A Study to Determine the Effect of Food on the Pharmacokinetics of Erdafitinib in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the effect of food on the relative
      bioavailability of a single 9 milligram (mg) oral dose of erdafitinib in healthy
      participants.
    


Intervention name(s): Erdafitinib
Intervention type(s): Drug
Intervention description(s): Erdafitinib 9 mg (provided as one 4-mg tablet [G-024] and one 5-mg tablet [G-025]) will be administered orally on Day 1 in each Treatment Period of assigned sequence.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Does the Diacutaneous Fibrolysis Change Ultrasonographic Measurements in Patients With Carpal Tunnel Syndrome?
Condition: Carpal Tunnel Syndrome; Physical Therapy Modalities; Ultrasonography
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      The carpal tunnel syndrome (CTS) is a common entrapment neuropathy caused by compression of
      the median nerve at the wrist.Clinically electroneuphysiological assessment is not accessible
      to all clinicians. In this way ultrasounds (US) is a more accessible and economical tool and
      many studies have reported that US has high sensitivity and specificity in the diagnosis of
      CTS.Diacutaneous Fibrolysis (DF) is a physiotherapeutic technique derived from Cyriax deep
      friction massage principles.DF technique could assist in improving changes in the connective
      tissues adjacent to the median nerve, especially the thickness of TCL and this could be
      reflected in a decreasing of TCL. Moreover, the neurophysiological and mechanical effect
      described by this technique may improve the nerve compression decreasing the CSA of the
      median nerve.

      The purpose of this study is to quantify changes in the cross-sectional area of the median
      nerve in the carpal tunnel and the thickness of transversal carpal ligament measured by US
      and the changes in the intensity of the numbness and the subjective assessment of clinical
      change after DF treatment in forearm, wrist and hand area compared to placebo.
    


Intervention name(s): Diacutaneous Fibrolysis
Intervention type(s): Other
Intervention description(s): Diacutaneous Fibrolysis is a non invasive physiotherapeutic technique applied by means of a set of metallic hooks ending a spatula with bevelled edges that help to treat the muscles and conjunctive tissues and trying to improve mobility between mobility between muscle planes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Lactoserum (Dermacyd Femina®) and Prevention of Recurrence of Bacterial Vaginosis
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases; Recurrence
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to demonstrate if the use of Dermacyd can avoid the recurrence
      of bacterial vaginosis after three months of the standard treatment.
    


Intervention name(s): Lactoserum (Dermacyd Femina®)
Intervention type(s): Drug
Intervention description(s): Once a day during three months
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Clinical Efficacy of Belting Stabilization for Shoulder Pain
Condition: Rotator Cuff Impingement Syndrome
MeSH terms: Shoulder Pain; Shoulder Impingement Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      Application of a belt for stabilization while exercising accelerate and optimize recovery in
      patients diagnosed with shoulder impingement syndrome.
    

Detailed description: 
      Stabilization through belts is commonly used as an adjunct for treatment of musculoskeletal
      problems. Although this treatment is popular among clinicians, there is a paucity of evidence
      on its use for shoulder pathology. The objective of this double-blinded longitudinal
      randomized controlled trial (RCT) is to determine the clinical efficacy of stabilization
      belting applied to patients receiving rehabilitation treatment for shoulder impingement
      syndrome. The study population will include patients who have been referred to the
      physiotherapy department of the Holland Orthopaedic & Arthritic Centre for conservative
      treatment. Patients will be randomized into the treatment and control groups. The primary
      outcome measure is the Quick Disabilities of Arm, Shoulder and Hand (QuickDASH)
      questionnaire.
    

Intervention name(s): Stabilization belt; Stabilization belt
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients receive true stabilization.; Patients receive sham stabilization.
Other intervention name(s): Belt Stabilization; Ineffective stabilization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Figure-Of-Eight Suture Perclose ProGlide Suture-Mediated Closure
Condition: Venous Puncture
Study type: Interventional

Summary: 
      The study proposes to compare specialized closure devices to achieve hemostasis with the
      Figure-of-eight suture technique.
    

Detailed description: 
      Procedures where patients requiring large bore venous access will be randomized 1:1 to either
      the Figure-of-eight suture technique or the Perclose Device to achieve hemostasis.
    

Intervention name(s): Figure-of-eight suture; Perclose Device
Intervention type(s): Other; Other
Intervention description(s): Using the figure-of-eight closure technique when closing access for structural heart therapies.; Using the Perclose device when closing access for structural heart therapies.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Perclose Device; Figure-of-eight suture