bioihbjkbjnl/mcl2 huggingface dataset:
A Bioequivalence Study of L04TD2 Compared to Administration of L04RD1 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open, single-dose, crossover-design, phase 1, singlecenter study to
      evaluate bioequivalence after administration of L04RD1 or administration of L04TD2 in healthy
      volunteers.
    


Intervention name(s): L04RD1; L04TD2; L04TD2; L04RD1
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1 tablet of L04RD1; 1 tablet of L04TD2; 1 tablet of L04TD2; 1 tablet of L04RD1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Feasibility of Drug Delivery to Infants During Breastfeeding
Condition: Medication Systems; Breast Feeding; Milk, Human; Infant, Newborn
Study type: Interventional

Summary: 
      Parents commonly find giving medicines to babies, using oral syringes or spoons, difficult
      and emotionally stressful. In developing countries, additional stress arises due to hygiene
      difficulties and the lack of clean water. To overcome these challenges and encourage
      breastfeeding, we have developed the concept of a Therapeutic Nipple Shield, a delivery
      system that makes it possible to give medicine and nutrients to babies during breastfeeding.
      It consists of a silicone nipple shield that allows the release of medicine/nutrients into
      human milk during the feed. Presentations of a prototype to parents and staff at the Rosie
      Hospital was very positive, and encouraged this clinical study. This study aims to give a
      vitamin B12 supplement to babies during breastfeeding. The supplement will be placed into a
      nipple shield, both of which are commercially available, and the mother will breastfeed her
      baby as usual. Before and after the feed, we will 1) collect a small blood sample from the
      baby to see whether the vitamin levels in the infant have increased, 2) ask the mother to
      participate in two short interviews about her expectations and experiences using the
      Therapeutic Nipple Shield.
    


Intervention name(s): Drug delivery during breastfeeding
Intervention type(s): Device
Intervention description(s): This study aims to give a vitamin B12 supplement to babies during breastfeeding. 30 mother-infant pairs will be recruited. The supplement will be placed into a nipple shield, both of which are commercially available, and the mother will breastfeed her baby as usual. Before and after the feed, we will 1) collect a small blood sample from the baby to see whether the vitamin levels in the infant have increased, 2) ask the mother to participate in two short interviews about her expectations and experiences using the Therapeutic Nipple Shield.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Long-term Follow up Helicobacter Pylori Reinfection Rate After Second-Line Treatment: Bismuth-Containing Quadruple Therapy Versus Moxifloxacin-Based Triple Therapy
Condition: Helicobacter Infections
MeSH terms: Helicobacter Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      patients who had failed previous H. pylori eradication on standard triple therapy were
      randomized into two regimens: 1, esomeprazole (20 mg b.i.d), tripotassium dicitrate
      bismuthate (300 mg q.i.d), metronidazole (500 mg t.i.d), and tetracycline (500 mg q.i.d)
      (EBMT) or 2, moxifloxacin (400 mg q.d.), esomeprazole (20 mg b.i.d), and amoxicillin (1000 mg
      b.i.d.) (MEA). At four weeks after completion of eradication therapy, H. pylori tests were
      performed with 13C urea breath test (UBT) or invasive tests (Giemsa histology, CLO test, and
      culture). In patients who maintained continuous H. pylori negativity for the first year after
      eradication therapy, H. pylori status was assessed every year. For the evaluation of risk
      factors of reinfection, gender, age, clinical diagnosis, histological atrophic gastritis or
      intestinal metaplasia were analyzed.
    


Intervention name(s): esomeprazole; tripotassium dicitrate bismuthate; metronidazole; tetracycline; moxifloxacin; amoxicillin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Amoxicillin; Moxifloxacin; Metronidazole; Tetracycline; Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetic Interaction Between Trospium With an Inhibitor of OCT1 and of P-gp in Subjects Genotyped for OCT1
Condition: Pharmacokinetics; Inhibition Enzyme; Drug Interaction Potentiation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is:

        -  to determine absolute bioavailability, input rates, distribution volume, renal and
           intestinal excretion of trospium in subjects with wild-type of SLC22A1 rs72552763 and
           rs12208357 and in subjects with homozygous variant alleles of SLC22A1 rs72552763 or
           rs12208357

        -  to determine absolute bioavailability, input rates, distribution volume and renal and
           intestinal excretion of trospium in subjects with wild-type alleles of SLC22A1
           rs72552763 and rs12208357 after co-medication of 300 mg of the OCT1- inhibitor
           ranitidine

        -  to determine absolute bioavailability, input rates, distribution volume and renal and
           intestinal excretion of trospium in subjects with wild-type alleles of SLC22A1
           rs72552763 and rs12208357 after co-medication of 500 mg of the P-glycoprotein- inhibitor
           clarithromycin

        -  to determine absolute bioavailability, input rates, distribution volume and renal and
           intestinal excretion of trospium in subjects with homozygous variant alleles of SLC22A1
           rs72552763 or rs12208357 after co-medication of 500 mg of the P-glycoprotein- inhibitor
           clarithromycin.
    


Intervention name(s): intravenous infusion of 2 mg trospium chloride; oral administration of 30 mg trospium chloride; oral administration of 300 mg ranitidine; oral administration of 500 mg clarithromycin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): intravenous infusion of 2 mg trospium chloride in 20 ml saline within 60 min and 240 ml tap water p.o; oral administration of 30 mg trospium chloride with 240 ml tap water; oral administration of 300 mg ranitidine with 240 ml tap water; oral administration of 500 mg clarithromycin with 240 ml tap water
Intervention MeSH terms: Clarithromycin; Ranitidine; Ranitidine bismuth citrate; Trospium chloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Effect of VOXX/eSmartr High Performance Technology on Sports Vision Ability
Condition: Vision, Binocular; Sports Medicine
Study type: Interventional

Summary: 
      This study is designed to compare the effect of Voxx/eSmartr technology on common measures of
      sports vision performance including (Hand-Eye Coordination/Reaction time, visual
      concentration and basic visual functions of size detection and contrast sensitivity). The
      study will be a randomized, prospective, double-blind design in order to determine the effect
      of this technology on a subject's sports vision ability.
    


Intervention name(s): Voxx socks and sleeves
Intervention type(s): Other
Intervention description(s): participants will be tested with a true device as well as with a placebo device
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: randomized, double blind, prospective
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Effect of Spinal Manipulation on Experimental Pain in Asymptomatic Subjects.
Condition: Spinal Manipulation
Study type: Interventional

Summary: 
      Spinal manipulation is often used for its effect on pain, but more information is needed
      concerning its mechanisms of action.
    

Detailed description: 
      The effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects
      should be challenged by a validated sham procedure, regionally and remotely over time.
      Further information is needed concerning its duration and its size.

      Research questions:

        1. What is the regional effect of spinal manipulation on the pressure pain threshold in
           asymptomatic subjects, when compared to a valid sham procedure?

        2. What is the remote effect of spinal manipulation on the pressure pain threshold in
           asymptomatic subjects, when compared to a valid sham procedure?

        3. What is the duration of the effect of spinal manipulation on the pressure pain threshold
           in asymptomatic subjects?

        4. What is the size of the effect of spinal manipulation on the pressure pain threshold in
           asymptomatic subjects over time?
    

Intervention name(s): Spinal manipulation; Sham procedure
Intervention type(s): Other; Other
Intervention description(s): Spinal manipulation is defined as a quick, passive and forced manoeuvre applied to spinal joints, and sometimes followed by a characteristic cracking sound. It can be compared to a mobilisation, which is a passive manual therapy as well, but is applied slower and repetitively on the joints. Spinal manipulation has been shown to have a significant clinical impact in the treatment of musculoskeletal pain; The sham procedure is a manual contact on both inferior angles of the scapulae by the chiropractor. After a short tensioning, a slight movement with low velocity and low amplitude is done, respecting scapula-thoracic sliding plans laterally, without repercussion on the spine. It is considered by us to be a "credible" sham procedure, as it resembles an actual act of thoracic manipulation, and it has been validated, with questionnaires
Other intervention name(s): Spinal manipulative therapy; Adjustment; Placebo procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pressure pain threshold; asymptomatic subjects; duration
Efficiency of Placental Drug Melsmon® in Correction of Climacteric Symptoms in Premenopausal Women
Condition: Climacteric Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The placental drug Melsmon® is effective for correction of insomnia and other climacteric
      symptoms in premenopausal women. Decrease of MMI is shown both in groups with Melsmon® and
      Placebo, but it was more significant in patients who used Melsmon®.
    

Detailed description: 
      There were 40 women under the observation, with mild and moderate symptoms of climacteric
      syndrome with sleep disorders (for that the investigators evaluated modified Kupperman
      Index).

      All patients were randomized with the help of the envelope method with the allocation ratio
      of 1:1 (one-to-one). 20 women were prescribed placenta extract Melsmon and 20 received
      placebo during 4 months.
    

Intervention name(s): Melsmon; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Placental extract Melsmon® (Japan): 2 ml (100 mg), subcutaneously, every 2nd day for 2 weeks, then twice a week (30 injections for 4 months in total).; 2 ml subcutaneously, every 2nd day for 2 weeks, then twice a week (30 injections for 4 months in total).
Other intervention name(s): Melsmon Pharmaceutical Co., Ltd.; Normal Saline Solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: menopause, climacteric syndrome, insomnia, placental extract
Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to assess noninferiority in efficacy and to assess overall safety of CT P13
      compared to Remicade in patients with active Crohn's disease up to Week 54.
    


Intervention name(s): CT-P13; Remicade
Intervention type(s): Biological; Biological
Intervention description(s): CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose; Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
An Exploratory Investigation of a Male Focused Skincare Supplement
Condition: Acne; Skin Abnormalities
MeSH terms: Skin Abnormalities
Study type: Interventional

Summary: 
      Most skincare products on the market are topical and do not take a holistic approach to
      understanding skin health. This trial will examine a dietary supplement designed to support
      the gut microbiome and promote skin health from an internal perspective. Research has
      previously supported the link between the gut microbiome and skin health and the supplement
      tested in this trial will further the knowledge on the effectiveness of supporting gut health
      to improve skin outcomes.
    


Intervention name(s): Daily Skin Supplement - Fountain of Youth
Intervention type(s): Dietary Supplement
Intervention description(s): Skincare supplement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Serum Antimullerian Hormone Levels Among Epileptic Patients
Condition: Epilepsy; Reproductive Issues
MeSH terms: Epilepsy
Study type: Interventional

Summary: 
      The production of AMH starts in granulosa cells before birth and the levels within the serum
      decreases towards the menapouse. The levels of AMH do not change throughout the menstruation
      cycle hovewer, it can be affected in cases related to body mass index (BMI), polycyctic
      ovarian syndrome (PCOS). The lower levels of AMH had been documented after ovarian surgery,
      radiotheraphy and chemotheraphy. AMH is a member of Transforming Growth Faktor β (TGF- β )
      and it has receptors in brain structures including hyppocammpus. It is highly active
      neurophysiologically and it has a protective effect against N-methyl-D -aspartate related
      neuronal injury that is demonstrated both in vivo and in vitro studies. As a result, being a
      neuroactive hormone; AMH may have an effect on seizures within epileptic patients or serum
      AMH levels may be effected in epileptic patients when compared with healthy ones.
    


Intervention name(s): serum antimullerian hormone
Intervention type(s): Diagnostic Test
Intervention description(s): serum antimullerian hormone will be analyzed for all participants
Intervention MeSH terms: Hormones
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: two groups (epileptic and healthy participants)
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: anti-mullerian hormone; epilepsy; adolescent
Brexpiprazole in Patients With Acute Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the efficacy and safety of brexpiprazole for the treatment of adults
      experiencing an acute episode of schizophrenia.
    


Intervention name(s): Placebo; Brexpiprazole; Quetiapine extended release
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Once daily as tablets and capsules, orally; 2-4 mg/day, once daily, tablets, orally; 400-800 mg/day, once daily, encapsulated tablets, orally
Other intervention name(s): Seroquel XL®/XR®
Intervention MeSH terms: Quetiapine Fumarate; Brexpiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Inmediate Effect of the Visualization of Action
Condition: Neck Pain; Chronic Pain; Musculoskeletal Pain
MeSH terms: Musculoskeletal Pain; Chronic Pain; Neck Pain
Study type: Interventional

Summary: 
      The observation of actions and motor imagery has demonstrated the activation of certain
      mechanisms similar to those that occur during active movement, which could induce immediate
      changes in the amplitudes of movement and sensorimotor variables in observed and imagined
      movements. The main aim of the study was test the immediate effect of a protocol of observed
      actions and motor imagery on cervical range of motion and pain intensity in patients with
      non-specific chronic neck pain (NSCNP). Randomized double-blind clinical trial in patients
      with DCCI at a primary health care center in the Community of Madrid. A random distribution
      of study subjects was made into two groups: a) cervical motion videos were presented at full
      range of motion and b) the videos presented showed a range of motion limited to 40%. In both
      groups, visualization tasks of actions were alternated with internal kinesthetic motor
      imagery, in periods of 1min in 2 consecutive series and with a total of 12 minutes of
      intervention. Cervical range of motion was assessed with a cervical goniometer and pain
      intensity immediately following the intervention with an Analog Visual Scale.
    


Intervention name(s): observed action and motor imaginery
Intervention type(s): Other
Intervention description(s): Observation of a video of neck movement and imagination of the same observed movement, feeling the realization of the movement but not developing it.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: motor imaginery; mental training
Effect of Dalfampridine (4-AP) on Genioglossus Muscle Activity in Healthy Adults
Condition: Sleep Apnea, Obstructive
MeSH terms: Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      In this protocol the investigators will test the effect of dalfampridine (a potassium channel
      blocker) on genioglossus muscle activity (EMG GG) during wakefulness and sleep in healthy
      control subjects.
    

Detailed description: 
      Two overnight sleep studies, a placebo night and a drug night, will be performed
      approximately one week apart in random order. The placebo or drug will be administered 3
      hours before lights out. At least 10 minutes of quiet wakefulness will be recorded to
      quantify the subject's awake EMG GG activity before the administration of
      placebo/dalfampridine.

      EMG GG activity will be measured again 10 mins before lights off and during stable NREM and
      REM sleep (free of arousals and other artifacts).

      During the second part of the night, the subjects will be connected to a modified continuous
      positive airway pressure (CPAP) machine (Pcrit3000, Respironics) which can provide a wide
      range of pressures between 20 and -20 cmH2O in order to modify upper airway pressure and
      measure change in EMG GG as a function of epiglottic pressure (muscle responsiveness).
    

Intervention name(s): Placebo; Dalfampridine
Intervention type(s): Drug; Drug
Intervention description(s): Placebo 3 hrs before sleep; Dalfampridine 10 mg extended release 3 hrs before sleep
Intervention MeSH terms: 4-Aminopyridine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Oral Health Promotion Program for Persons With Severe Mental Illness
Condition: Evaluate the Effects of an Oral Health Promotion Program
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      A cluster randomized controlled study was carried out in chronic psychiatric wards of a
      general hospital in central Taiwan. Sixty-eight eligible male individuals admitted to 2 wards
      were randomly assigned to an experimental and a control group. Participants in the
      experimental group underwent an oral health promotion program that consisted of biweekly
      group education sessions, and a 12-week individual behavioral modification for oral hygiene
      course. The participants in the control group received usual care only. Dental plaque
      (measured by the Plaque Control Index) was examined by a single dentist before and after the
      experiment.
    


Intervention name(s): a composite intervention with both group and individual components for oral health promotion program
Intervention type(s): Behavioral
Intervention description(s): The group intervention consisted of:
1. Group oral health education 2. Display of Bass tooth-brushing methods 3. Broadcasting of songs as tooth-brushing reminders; The individual interventions included:
1. Instruction in the Bass tooth-brushing method, 2. Individual behavioral modification method
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cluster Randomized Controlled Study
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: oral health, promotion program, plaque index, mental illness
A Phase 2 Study to Evaluate the Safety and Efficacy of Intravenously Administered Benralizumab (MEDI-563).
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will evaluate the effect of two intravenous dose regimens of benralizumab
      (MEDI-563) on the proportion of adult subjects with asthma exacerbations who required an
      urgent healthcare visit for treatment of an acute asthma exacerbation.
    

Detailed description: 
      The study will evaluate the effect of two intravenous dose regimens of benralizumab
      (MEDI-563) (0.3 milligram per kilogram [mg/kg] of body weight and 1.0 mg/kg of body weight)
      on the proportion of adult subjects with asthma exacerbations (relapse and de novo) who
      required an urgent healthcare visit for treatment of an acute asthma exacerbation.
    

Intervention name(s): Placebo; Benralizumab
Intervention type(s): Other; Biological
Intervention description(s): A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0.; A single dose of benralizumab (MEDI-563) 0.3 or 1 mg/kg of body weight intravenous infusion over at least 30 minutes on Day 0.
Other intervention name(s): MEDI-563
Intervention MeSH terms: Benralizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Benralizumab; MEDI-563; Asthma
Study to Investigate the Effect of Deferasirox on the Pharmacokinetics of Midazolam
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to investigate the pharmacokinetics of deferasirox
    


Intervention name(s): Deferasirox
Intervention type(s): Drug
Intervention MeSH terms: Deferasirox
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Interaction; healthy volunteers; deferasirox; midazolam