bioihbjkbjnl/mcl2 huggingface dataset:
Diaphragm Activity During Incentive Spirometry and Diaphragmatic Breathing
Condition: Diaphragm Mobility; Breathing Exercises; Incentive Spirometry; Diaphragmatic Breathing
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the present study is to evaluate diaphragm activity during three breathing
      exercises: diaphragmatic breathing (DB), flow-oriented (Triflo II)incentive spirometry and
      volume-oriented (Voldyne) incentive spirometry.

      Seventeen healthy subjects will be studied (8 man and 9 woman).
    

Detailed description: 
      Right diaphragmatic mobility will be evaluated by determining the craniocaudal displacement
      of the left branch of the portal vein using a B-mode ultrasound device (Logic 500, Pro
      Series®; General ElectricMedical Systems, Milwaukee, WI, USA). The ultrasound technician will
      use a 3.5 MHz convex transducer positioned in the right subcostal region, with the incidence
      angle perpendicular to the craniocaudal axis, in the direction of the inferior vena cava.
      Next, an intraparenchymal portal branch will be identified in the field of vision and its
      position will be traced with the curser during the forced inspiration and expiration. The
      craniocaudal displacement of these points will be considered to be the amount of right
      diaphragmatic mobility.
    

Intervention name(s): DB, VI and FI
Intervention type(s): Device
Intervention description(s): Two modalities of respiratory exercises based on deep and slow inspirations will be used: DB and IS. During DB, the researcher will place one hand slightly below the lower ribs in the abdominal region of the subject and the subject will be instructed to perform inspirations up to the maximum level of volume avoiding rib cage displacement; this recommendation will also be valid for exercises using incentive spirometers. IS will be executed using two different devices: Triflo II and Voldyne.
Other intervention name(s): diaphragmatic exercice; incentive spirometry
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: incentive spirometry; diaphragm mobility; ultrasound; diaphragmatic breathing
Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986141 in Healthy Subjects
Condition: Thrombosis
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and
      pharmacodynamics (PD) of a single and multiple oral doses of BMS-986141 in healthy subjects.
    

Detailed description: 
      Maximum Age:

      Part A SAD 65 years

      Part B MAD 75 years

      Part C MAD Japanese 75 years
    

Intervention name(s): BMS-986141; Placebo; Aspirin; Itraconazole
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Aspirin; Itraconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Testing the Nocturnal Sleep Latency Profile in Primary Insomnia
Condition: Primary Insomnia; Sleep Initiation and Maintenance Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Observational

Summary: 
      This study tests a new kind of sleep study in which subjects are awakened 2 times after
      initially going to sleep. The study focuses on the EEG signal process as a person goes to
      sleep. The general hypothesis is that the signal properties are stable from night to night
      during baseline studies, and are different between controls and patients with primary
      insomnia. The primary insomnia patients then go on to have about 2 weeks of an insomnia
      intervention. Then the new kind of study is repeated in the patients. The controls only are
      examined in baseline studies.
    

Detailed description: 
      Patients are carefully screened to have DSM primary insomnia, and do not have another
      disorder than may cause a sleep disturbance. After a 2-week baseline period, the subjects
      undergo a screening sleep study to rule out sleep apnea and periodic limb movement disorder.
      Then they undergo the NSLP procedure. In that procedure, there pre-bedtime EEG recordings and
      questionnaire responses taken. Then at a planned time, the subjects go to bed and try to
      sleep while there EEG signals are recorded. After the first and second sleep cycles, they are
      awakened for one minute, then asked to return to sleep. In the morning additional recordings
      and questionnaire responses are obtained. Two nights later they repeat a baseline NSLP
      procedure. The controls then end their participation. The Patients then receive an open
      treatment with eszopiclone and behavioral treatments so that their insomnia may improve.
      After 2 weeks intervention, the patients complete one NLSP night. The goal of the study is to
      see if there can be data to support the idea that the sleep onset process might harbor a sign
      of primary insomnia that could be used for the development of a better medical model of
      primary insomnia.
    

Intervention name(s): eszopiclone 3 mg qHS; General cognitive/behavioral interventions for insomnia
Intervention type(s): Drug; Behavioral
Intervention MeSH terms: Eszopiclone
Time perspective: Prospective
Keywords: Insomnia; polysomnography; sleep onset; time series analysis
The Effect of Partial and Complete Sleep Deprivation on Heat Tolerance
Condition: Sleep Deprivation
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      The purpose of the present study is to evaluate the effect of partial and complete sleep
      deprivation on exercise heat tolerance. Twelve healthy young male volunteers will participate
      in the study. They will arrive to our lab four times, in each visit the will undergo VO2 test
      and Heat Tolerance Test (HTT) after sleeping different amount of hours.
    

Detailed description: 
      The volunteers will arrive to our lab fout times- During their first visit they will go
      through a VO2 max test in order to evaluate their aerobic fitness, and their physiological
      efficiency will be measured. During their second visit they will go through an exercise heat
      tolerance test according to our validated protocol after a full night sleep. During the third
      and fourth visit they will go through an exercise heat tolerance test and a measurement of
      their physiological efficiency after a partial and complete sleep deprivation, respectively.
      The physiological tests will take place in the heat chamber that is located at the Heller
      Institute of Medical Research. The results will be then analyzed, and a comparison between
      the physiological measurements during the heat tolerance tests and the physiological
      efficiency tests after the various sleep conditions will be performed.
    

Intervention name(s): partial and complete sleep deprivation
Intervention type(s): Other
Intervention description(s): The subjects will visit our labs 4 times. The second visit will be used as the experimental control. During the third and fourth visits the subject will go through an exercise heat tolerance test and a measurement of their physiological efficiency after a partial and complete sleep deprivation, respectively.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: sleep; HTT; heat illness
Determine the Effect of Multiple Doses of AZD7325, CYP Study
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the effects of repeated doses of AZD7325 on the pharmacokinetic profile of a
      CYP3A4 substrate (midazolam and its 1' hydroxy metabolite) and a CYP1A2 substrate (caffeine
      and its paraxanthine [3-desmethyl] metabolite).
    


Intervention name(s): AZD7325; Midazolam; Caffeine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral, day 1-12; single dose, twice during treatment; single dose, twice during treatment
Intervention MeSH terms: Midazolam; Caffeine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Phase I
Nutrition and Pregnancy Intervention Study
Condition: Pregnancy; Obesity; Gestational Diabetes Mellitus; Adiposity; Type2 Diabetes; Cardiovascular Risk Factor; Eating Behavior; Liver Diseases; Neurodevelopmental Disorders; Cognitive Developmental Disorders
MeSH terms: Liver Diseases; Diabetes, Gestational; Diabetes Mellitus; Neurodevelopmental Disorders; Developmental Disabilities
Study type: Interventional

Summary: 
      A randomized double-blind placebo controlled intervention study with pregnant obese women
      (n=440) will be conducted. The intervention will involve consumption of fish oil and/or
      probiotic capsules from early pregnancy until 6 months after delivery.

      The aim of the study is firstly to investigate the effects of the supplements on the risk of
      gestational diabetes mellitus and obesity in the women and secondly to modify the risk
      markers of allergy and obesity in children of the women. Also the underlying metabolic
      mechanisms will be investigated.

      Follow up visits at child's age of 5 to 6 years will be conducted to evalute long-term
      effects on maternal and child health. The aim is to investigate the impact of dietary
      intervention, diet, maternal overweight/obesity and gestational diabetes status as well as
      gut microbiota and metabolism during pregnancy on maternal and child's health, allergy and
      child neuropsychological development.
    


Intervention name(s): Comparison of probiotics, fish oil and their combination to placebo
Intervention type(s): Dietary Supplement
Intervention description(s): Double-blind randomized placebo controlled intervention
Other intervention name(s): Lactobacillus and Bifidobacterium; Fish oil; Placebo, microcrystalline cellulose; Placebo, medium-chain triglycerides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Nutrition; Probiotics; Fish oil
Establishing Normal Values for Neuropsychological Testing in HIV-negative Thais
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      The purpose of this study is to establish normal values for neuropsychological testing in HIV
      negative Thais stratified by age (1 decade) and education (no certificate or primary school
      certificate, less than high school certificate or vocational certificate, high school
      certificate or higher vocational certificate or diploma, Bachelor degree or higher.
    

Detailed description: 
      The Southeast Asia Research Collaboration with Hawaii (SEARCH) operates or collaborates on
      several neuroAIDS research protocols. To allow accurate interpretation of neuropsychological
      data, normative data that are obtained in a similar population are needed. Currently, there
      are limited such data available for this purpose.

      The SEARCH 001 study evaluated the neurocognitive changes before and after highly active
      antiretroviral therapy in 30 HIV positive subjects and has also enrolled 230/300 proposed
      HIV-negative controls for this purpose. Normative data tables typically require many more
      individuals so that age and education strata can be established. We now propose to enroll up
      to 1000 HIV-seronegative individuals for this purpose.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        HIV-negative Thais
      
Keywords: HIV-negative
Nutritive Effects of Prebiotics on Early Postnatal Behavioral Measures of Tolerance
Condition: Behavioral Measures of Tolerance
Study type: Interventional

Summary: 
      The study is intended to measure infant comfort, behavior, and sleep when consuming study
      formula with prebiotics compared to infants who consume a study formula without the
      prebiotics.
    


Intervention name(s): Previously marketed cow's mlik-based infant formula; Marketed cow's milk-based infant formula with prebiotics
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Acupressure in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      The goal of this pilot trial is to better understand if acupressure is feasible and tolerable
      to people with rheumatoid arthritis.
    


Intervention name(s): Acupressure
Intervention type(s): Device
Intervention description(s): The MeTime Acupressure app will be loaded onto computer tablets or smart phones by the participants. Participants will also receive an AcuWand to be used in association with the acupressure app to help participants apply the correct amount of pressure to acupoints. There are 9 acupressure points, totaling 27 minutes of stimulation per day. Participants will perform daily acupressure for a total of six weeks.
In addition all participants will complete a battery of validated questionnaires before, during and after completion of treatment intervention.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acupressure; AcuWand; MeTime
Comparing the Therapeutic Efficacy and Safety of DA-9701 With Domperidone in Patients With Parkinson's Disease
Condition: Parkinson's Disease,Idiopathic
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the therapeutic efficacy and safety of DA-9701 with domperidone in
      patients with Parkinson's disease
    

Detailed description: 
      To prevent nausea and vomiting induced by anti-parkinsonian drugs, prokinetic drugs are
      frequently prescribed in patients with Parkinson's disease (PD). Additionally, there has been
      some evidence that prokinetics might improve PD symptom fluctuations. From this background,
      the investigators will evaluate the therapeutic efficacy and safety of DA-9701 in PD
      patients.

      In this study, 40 patients will be enrolled and randomly allocated 1:1 to receive either
      domperidone or DA-9701. The gastric function of each study participant will be evaluated
      using the MRI technique before and after 4 weeks of the treatment. The study participants
      will also be subjected to complete the gastrointestinal symptom diary before and during the
      treatment period. In addition, plasma levodopa concentrations will be determined 30 minutes
      after dose administration before and after treatment.
    

Intervention name(s): DA-9701; Domperidone; Placebo domperidone; Placebo DA-9701
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Following 2-week screening period, study participants in this group will be given a standard dose of DA-9701 (30 mg t.i.d). Concomitant anti-PD medication will be continued without modification during the trial. The investigators will evaluate dyspepsia and constipation symptoms, gastric emptying by MRI, UPDRS and clinical variables at baseline and at the end of the study.; Following 2-week screening period, study participants in this group will be given a standard dose of domperidone (10 mg t.i.d). Concomitant anti-PD medication will be continued without modification during the trial. The investigators will evaluate dyspepsia and constipation symptoms, gastric emptying by MRI, UPDRS and clinical variables at baseline and at the end of the study.
Other intervention name(s): Motilitone; Motilium-M
Intervention MeSH terms: Domperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Motilitone
An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (0431-024)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this investigational study is to determine the safety and effectiveness of an
      investigational drug in patients with type 2 diabetes mellitus (a specific type of diabetes).
    

Detailed description: 
      The duration of treatment is 104 weeks.
    

Intervention name(s): sitagliptin (MK0431); Comparator: glipizide
Intervention type(s): Drug; Drug
Intervention description(s): Sitagliptin 100 mg oral tablets of sitagliptin once daily.; Glipizide 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
Other intervention name(s): MK0431; Glipizide
Intervention MeSH terms: Sitagliptin Phosphate; Glipizide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Treating Postmenopausal Dyspareunia Where it Hurts
Condition: Dyspareunia
MeSH terms: Dyspareunia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the effectiveness of two low doses of estrogen cream
      applied to a new location for the treatment of moderate or severe pain during sexual
      intercourse in postmenopausal women.
    

Detailed description: 
      Estrogen cream is FDA-approved for vaginal use for the treatment of sexual pain, but its use
      in a new location is experimental. Pain with sex is a common problem experienced by women
      after menopause and the relationship of pain to sexual difficulties is well established. The
      cause has been assumed to be atrophy and the location has been assumed to be the vagina.
      Recent focused studies have shown that the location of pain is the vulvar vestibule and
      usually not the vagina. This study will look at pain before and after therapy with estrogen
      when only the vulvar entryway area is treated. This will be a study focused on sexual
      dysfunction in postmenopausal women.
    

Intervention name(s): 50mcg estradiol cream; 100mcg estradiol cream
Intervention type(s): Drug; Drug
Intervention description(s): Use of study drug nightly applied to vulvar vestibule; Use of study drug nightly
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Post-menopause dyspareunia; Vulvar vestibular pain; Genitourinary syndrome of menopause; Sexual pain
Antioxidant Effect of Ozonated Vegetable Oil and Vitamins in Moderately Active Subjects
Condition: Oxidative Stress; Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The purpose of this pilot study is to evaluate the antioxidant effect of a nutraceutical
      formulation based on vegetable oil and vitamin complex (vitamin K2 and vitamin B9) in
      subjects with the same level of physical activity (LAF 1.70-1.99, normally active or
      moderately active).
    

Detailed description: 
      Study design: The pilot study will enroll 20 subjects with physical activity level LAF
      1.70-1.99 (normally active or moderately active).

      The 20 subjects will be divided into two groups of 10 subjects following randomization. The
      first group will take the dietary supplement (three capsules per day) for 60 days, while the
      second group will take a placebo (three capsules per day) for 60 days.

      During the treatment period (60 days), the two groups will undergo follow-ups at days 0, 15,
      30 and 60 within which clinical and hematochemical examinations will be conducted. At the end
      of the 60 days, after the wash-out period (two weeks), as per the cross-over design the group
      previously taking the dietary supplement will be on placebo (three capsules per day) for 60
      days, while the group previously taking placebo will take the dietary supplement (three
      capsules per day) for 60 days. Again, follow-ups will be at 0, 15, 30 and 60 days.
    

Intervention name(s): Ozonized vegetable oil with vitamines
Intervention type(s): Dietary Supplement
Intervention description(s): description: A single capsule is composed by ozonized vegetable oil (75 mg), vitamin K2 (20 mcg), vitamin B9 (130 mcg). The posology is three capsules/day.
The time of administration is two months.
Intervention MeSH terms: Vitamins
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Twenty subjects will be divided into two groups of 10 subjects following randomization. The first group will take the dietary supplement (three capsules per day) for 60 days, while the second group will take a placebo (three capsules per day) for 60 days.
During the treatment period (60 days), the two groups will undergo follow-ups at days 0, 15, 30 and 60 within which clinical and hematochemical examinations will be conducted as per Table 2. At the end of the 60 days, after the wash-out period (two weeks), as per the cross-over design the group previously taking the dietary supplement will be on placebo (three capsules per day) for 60 days, while the group previously taking placebo will take the dietary supplement (three capsules per day) for 60 days. Again, follow-ups will be at 0, 15, 30 and 60 days.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: ozonated sunflower oil; antioxidant; inflammation