bioihbjkbjnl/mcl2 huggingface dataset:
Interoceptive Engagement
Condition: Stress
Study type: Interventional

Summary: 
      The proposed project is the first pilot test to examine interoceptive function as a
      mechanistic biomarker underlying Mindful Awareness in Body-oriented Therapy (MABT). MABT, an
      empirically-validated and manualized protocol is explicitly designed to teach interoceptive
      awareness skills for emotion regulation and is thus an ideal intervention approach in which
      to address this gap in research. This study uses a two group, randomized design to examine
      neural and physiological biomarkers in response to MABT. Twenty-four individuals reporting
      moderate stress will be recruited from the community and randomized to 8-week MABT
      intervention or the control condition. The study aims are to: 1) evaluate whether
      interoceptive training improves interoceptive function in the MABT vs control condition, and
      2) explore whether changes in interoceptive function correlate with improved health outcomes.
      Analyses will include within and between-group ANOVA of brain activity with symptom change as
      a covariate. This is the first study to test whether a clinical intervention aimed
      specifically at cultivating interoceptive awareness effects change on interoceptive
      biomarkers. The results will support larger NIH proposals to more comprehensively validate
      neuro and behavioral biomarkers of interoceptive training to enhance mental health,
      particularly targeting depression and substance use disorder that have identified
      interoceptive dysfunction and poor emotion regulation.
    


Intervention name(s): Mindful Awareness in body-oriented therapy
Intervention type(s): Behavioral
Intervention description(s): teaches interoceptive awareness skills for self care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this prospective, multicenter, open-label, efficacy, and safety study is to
      assess the efficacy and safety of ocrelizumab in participants with Relapsing Remitting
      Multiple Sclerosis (RRMS) who have had a suboptimal response to an adequate course of a
      Disease-Modifying Treatment (DMT). The study will consist of a Screening period (up to 4
      weeks), an Open-label treatment period (96 weeks; with last dose administered at Week 72),
      and a Follow-up period of at least 2 years.
    


Intervention name(s): Ocrelizumab
Intervention type(s): Biological
Intervention description(s): Ocrelizumab will be administered as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Other intervention name(s): RO4964913
Intervention MeSH terms: Ocrelizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Exercise and Weight Control
Condition: Overweight; Obese
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to research the effects of exercise on calories eaten and
      expended. The investigator expects to find out whether subjects change their eating and
      activity behaviors when starting an exercise program.
    


Intervention name(s): Exercise Energy Expenditure 300 kcal/day; Exercise Energy Expenditure 600 kcal/day
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: obese; overweight; exercise; energy expenditure differences; relative reinforcing values (RRV); food; physical activity; biological; neurobehavioral; behavioral
Higher Enjoyment in Response to High Intensity Interval Training Versus Moderate Intensity Continuous Exercise
Condition: Exercise Training
Study type: Observational

Summary: 
      Previous research is equivocal concerning if high intensity interval training is viewed as
      more aversive versus moderate exercise. Our data in active men and women showed that interval
      training is viewed as more enjoyable than higher volume moderate exercise.
    

Detailed description: 
      Twelve men and women who were habitually active initially performed ramp exercise on a cycle
      ergometer to assess maximal oxygen uptake (VO2max) and peak power output (PPO), which was
      used to determine workload for the subsequent 2 bouts. They returned at least 48 h later at
      the same time of day to complete high intensity interval training (HIIT consisting of
      repeated 1 min bouts at 85 %PPO) or moderate intensity continuous training (MICT consisting
      of 25 min at 40 %PPO). During exercise, heart rate, oxygen uptake, perceived exertion,
      pleasure:displeasure, and blood lactate concentration were continuously assessed. Ten minutes
      post-exercise, physical activity enjoyment was measured. Data showed that despite higher
      oxygen uptake, heart rate, blood lactate concentration, and perceived exertion in HIIT,
      enjoyment was higher in HIIT versus MICT.
    

Intervention name(s): Exercise intensity
Intervention type(s): Other
Intervention description(s): Participants were randomized to 1 or 2 exercise intensities, moderate or high (interval training).
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Habitually active young men and women ages 18-45 yr
A Study to Investigate the Association of Real-world Sensor-derived Biometric Data With Clinical Parameters and Patient-reported Outcomes for Monitoring Disease Activity in Patients With COPD
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The purpose of this multicenter, prospective cohort study is to investigate the correlation
      of real-world sensor-derived biometric data obtained via a wearable device with clinical
      parameters and patient-reported outcomes (PROs) for monitoring disease activity and
      predicting exacerbations for participants with Chronic Obstructive Pulmonary Disease (COPD).
      The cohort of participants with COPD will be followed for 3 months. A calibration cohort with
      non-COPD participants will be included and followed for 2 weeks.
    


Intervention name(s): Vivalink wearable device
Intervention type(s): Device
Intervention description(s): a CE marked device modified to add a temperature measurement algorithm in addition to ECG and respiratory rate measurements
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
The Effect of Intravenous (IV) Patient Controlled Analgesic (PCA) With Ketorolac or Fentanyl Combined With Caudal Block for Postoperative Analgesia in Small Children Undergoing Intravesical Ureteroneocystostomy
Condition: Ureteroneocystostomy
Study type: Interventional

Summary: 
      The effect of IV PCA with ketorolac or fentanyl combined with caudal block for postoperative
      analgesia in small children undergoing intravesical ureteroneocystostomy.
    


Intervention name(s): ketorolac, fentanyl
Intervention type(s): Drug
Intervention description(s): intravenous PCA
Intervention MeSH terms: Ketorolac; Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Pediatric patients (6 months-5 years) scheduled elective ureteroneocystostomy
Bioequivalence Study of Rivaroxaban in Japanese Healthy Adult Male Subjects
Condition: Embolism, Atrial Fibrillation and Venous Thrombosis
MeSH terms: Atrial Fibrillation; Thrombosis; Embolism; Venous Thrombosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are to establish the bioequivalence between rivaroxaban tablet
      10mg and rivaroxaban granule formulation 10mg, and to assess the safety and tolerability of
      rivaroxaban 10mg in healthy adult male subjects.
    


Intervention name(s): Rivaroxaban (BAY 59-7939); Rivaroxaban (Xarelto, BAY 59-7939)
Intervention type(s): Drug; Drug
Intervention description(s): Rivaroxaban granule 10mg for one day; Rivaroxaban tablet 10mg for one day
Intervention MeSH terms: Rivaroxaban
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Injections of LY3074828 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to learn about the effects of LY3074828 when given as an
      injection just under the skin by two different devices. The study will last about 12 weeks
      for each participant.
    


Intervention name(s): LY3074828; PFS; AI
Intervention type(s): Drug; Device; Device
Intervention description(s): Administered subcutaneously (SC); PFS used to administer LY3074828; AI used to administer LY3074828
Intervention MeSH terms: Mirikizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluation of the Effectiveness of the Video Prepared to Raise Cervical Cancer Awareness in Women Between the Ages of 18 and 65 Via Social Media.
Condition: Being a Woman Aged 18-65
MeSH terms: Uterine Cervical Neoplasms
Study type: Observational

Summary: 
      This research, a quasi-experimental study based on the comparison of the pre-test and
      post-test results of individuals in a single group is conducted to raise awareness about
      cervical cancer in women aged 18-65 years. The questionnaire includes 32 questions about the
      individual's socio-demographic characteristics, pregnancy, and sexual life information,
      cervical cancer, pap-smear test, and HPV vaccine information, as well as a 27-item 3-point
      likert type to measure cervical cancer risk factors, symptoms, and prevention. A survey form
      consisting of 61 questions, consisting of 2 questions and 2 guestions for evaluating the
      animated training video, and an informative animated training video of 4 minutes and 33
      seconds constituted the data collection tools. During the Covid-19 pandemic, the study has
      completed with 433 people who participated voluntarily by directing the participants via
      online platforms (WhatsApp / Instagram / E-mail) using the snowball sampling method of survey
      applications. The women who participated in the research completed the first part by watching
      the informative animated training video at the end of the questionnaire form.
    


Intervention name(s): No any intervation.
Intervention type(s): Other
Intervention description(s): This research, a quasi-experimental study based on the comparison of the pre-test and post-test results of individuals in a single group is conducted to raise awareness about cervical cancer in women aged 18-65 years.
Other intervention name(s): This research, a quasi-experimental study based on the comparison of the pre-test and post-test results.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The population of the study consists of women aged 18-65 living in our country. In 2018
        TUIK data, it was stated that the average number of women between the ages of 18-65 was 33
        million, and the minimum number of women to be reached was found to be 385, as a result of
        calculating the sample with a known sample, taking into account the 5% margin of error and
        95% confidence level. During the Covid-19 pandemic, survey applications were directed
        through the online platform (WhatsApp / Instagram / E-mail) using the snowball sampling
        method, and 433 people who agreed to participate voluntarily between 01 April and 01 June
        2021 and met the inclusion criteria constituted the sample of the research.
      
Keywords: Cervical Cancer; Social Media; Awareness; HPV; Pap-smear
Comparison of Virtual Reality to Tablet-based Distraction in Children
Condition: Anxiety, Separation
MeSH terms: Anxiety, Separation
Study type: Interventional

Summary: 
      The proposed study is a prospective randomized trial to be performed in pediatric patient's
      ages 4 to 10 years undergoing surgical procedures requiring general anesthesia. The purpose
      is to compare the effectiveness of interactive tablet devices vs. Virtual Reality headsets.
      The primary outcome measure being patient anxiety at the time of separation. Other comparison
      measures will include preoperative parent/caregiver anxiety, anesthesia mask acceptance
      characteristics at the time of induction, and time to fully recover in the post-operative
      period.
    

Detailed description: 
      After receiving IRB approval from our institution and consent from parents or guardians, ASA
      I or II status children ages 4 - 10 presenting for surgery requiring general anesthesia were
      recruited for this study. They were assigned to either tablet- or VR-based groups. At our
      institution, tablet-based distraction is widely used and represents standard practice.
      Children in this control group were given tablets in the preoperative holding area before
      transport to the operating room. Content consisted of entertainment apps providing access to
      music videos, movies and games targeting various age groups.

      The study group was given a Virtual Reality Smartphone headset in the preoperative holding
      area prior to transport to the operating room. This headset was chosen because of its low
      cost and wide compatibility for a variety of smartphones. The content consisted of several VR
      environments that the child/parent could choose from.

      In both groups, the distraction with tablet or VR was continued throughout separation from
      caregivers, transport to the operating room, placement of monitors and mask induction of
      general anesthesia. Anxiety at time of separation was measured by the modified Yale
      Preoperative Anxiety Scale (mYPAS). Caregiver anxiety was measured using the State-Trait
      Anxiety Inventory for Adults (STAI). Mask acceptance at induction of anesthesia was
      determined by using the Mask Acceptance Scale.
    

Intervention name(s): Separation Anxiety
Intervention type(s): Behavioral
Intervention description(s): Perioperative anxiety is a common, undesirable outcome in pediatric surgical patients and has been associated with adverse outcomes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Evaluate the Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females
Condition: HPV Infections; Cervical Cancer; Vulvar Cancer; Vaginal Cancer; CIN1; CIN2; CIN3; VaIN1; VaIN2; VaIN3; Genital Wart; VIN 1; VIN 2; VIN 3; AIS
MeSH terms: Papillomavirus Infections; Condylomata Acuminata; Vulvar Neoplasms; Vaginal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will evaluate the immunogenicity and safety of 9-valent HPV recombinant vaccine in
      Chinese healthy females16 to 26 years of age.
    


Intervention name(s): Experimental: Experimental: 9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58); Active Comparator: GARDASIL ®9
Intervention type(s): Biological; Biological
Intervention description(s): 9vHPV vaccine ,0.5mL, three doses, 0,2,6 months; GARDASIL®9 vaccine, 0.5mL, three doses, 0,2,6 months
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Drug Interaction Study of the Effect on Cyclosporine on Ozanimod and Major Active Metabolites
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, parallel-group, open-label study. Forty subjects will be
      enrolled and will be randomized into 1 of the 2 treatment groups, with 20 subjects in each
      treatment group(sex will be used as a stratifying factor) as follows:

        -  Treatment Group A (reference): A single oral dose of ozanimod 0.46 mg

        -  Treatment Group B (test): A single oral dose of ozanimod 0.46 mg plus a single oral dose
           of cyclosporine 600 mg
    


Intervention name(s): Ozanimod; Cyclosporine
Intervention type(s): Drug; Drug
Intervention description(s): Ozanimod; Cyclosporine
Intervention MeSH terms: Cyclosporine; Cyclosporins; Ozanimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Subjects; Ozanimod; Cyclosporine
Interaction With HIV Antiretroviral Agents
Condition: HIV-DDI
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the pharmacokinetic drug-drug interaction potential of fixed dose
      antiretroviral therapies, i.e. ATRIPLA, COMPLERA, STRIBILD, TRIUMEQ, or any approved
      antiretroviral protease inhibitor in combination with (preferably) TRIUMEQ, on the exposure
      to riociguat in HIV patients on a stable dose of one of these therapies.

      • To Assess the safety and tolerability of riociguat treatment in combination with these
      fixed-dose antiretroviral therapies.
    


Intervention name(s): Riociguat (Adempas, BAY 63-2521); ATRIPLA; COMPLERA; STRIBILD; TRIUMEQ; Antiretroviral protease inhibitor
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 0.5 mg, Oral (fasted conditions), 1 single dose; 600 mg efavirenz, 200 mg emtricitabine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily; 200 mg emtricitabine, 25 mg rilpivirine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily; 150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily; 600 mg abacavir, 50 mg dolutegravir, and 300 mg lamivudine, i.e. 1 tablet, once daily; Any approved antiretroviral protease inhibitor such as atazanavir, darunavir, indinavir, ritonavir, and saquinavir ; consistent with the most recent prescribing information documents
Intervention MeSH terms: Anti-Retroviral Agents; Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Abacavir, dolutegravir, and lamivudine drug combination; Emtricitabine, Rilpivirine, Tenofovir Drug Combination; HIV Protease Inhibitors; Riociguat; Protease Inhibitors
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Single-Dose, Open-Label, Non-Blinded, Non-Placebo-; Controlled, Stratified Design
Effects of Gonadotropin Replacement Therapy on Metabolic Parameters in Patients With Hypogonadism
Condition: Idiopathic Hypogonadotropic Hypogonadism
MeSH terms: Hypogonadism
Study type: Observational

Summary: 
      Effects of gonadotrophin replacement therapy Lipid Profile and Oxidative Stress Parameters of
      Patients with Idiopathic Hypogonadotropic Hypogonadism
    

Detailed description: 
      30 male patients diagnosed with IHH and a control group of 20 healthy cases with similar age
      and BMI were included in the study. The levels of advanced oxidation protein products (AOPP),
      thiol, malondialdehyde (MDA), nitric oxide (NO) and 8-hydroxydeoxyguanosine (8-OHdG) and the
      levels of triglyceride (TG), total cholesterol (TC), high density lipoprotein (HDL-K), low
      density lipoprotein (LDL-K), Apolipoprotein A1 (ApoA1) and Apolipoprotein B100 (ApoB100) were
      measured before and after gonadotrophin therapy.
    

Intervention name(s): human chorionic gonadotropin, human menopausal gonadotropin
Intervention type(s): Drug
Intervention description(s): drug for the treatment of male hypogonadism
Other intervention name(s): Pregnyl ® Organon hCG 1500 IU; Merional ® ARIS 75 IU
Intervention MeSH terms: Chorionic Gonadotropin; Menotropins
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with Idiopathic Hypogonadotropic Hypogonadism and healthy control group
Fasting Bioequivalence Study of 2 Oral Progesterone Soft Capsules 200 mg in 48 Healthy Female Subjects
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was designed to assess the bioequivalence of single oral dose of Progesterone 200
      mg Soft Capsule (JSC "Farmak", Ukraine) Versus Utrogestan® 200 mg Soft Capsule (Manufacturer
      by: Cyndea Pharma, S.L., Spain, MAH: Laboratoires Besins International, France) In healthy
      female subjects under fasting conditions
    

Detailed description: 
      An open-label, randomized, single dose, two-treatment, four-period, two-sequence, fully
      replicated crossover bioequivalence study with a washout period of 7 days in healthy
      postmenopausal female subjects under fasting conditions.

      During each period 26 blood samples were drawn 5 mL at (-1.00, -0.50, -0.137) before dosing
      and at 0.50, 1.00, 1.50, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00,
      8.00, 9.00, 10.00, 12.00, 16.00, 24.00, 48.00, 72.00 and 96.00 hours after dosing.

      Mode of administration: Orally, with 240 mL of water at dosing in sitting position

      Bioequivalence Acceptance Criteria:

      ▲Cmax (Maximum plasma concentration): Scaled average bioequivalence will be performed.
      Bioequivalence limits will be defined and widened according to the variance of σw2 within
      subject variability for the reference based on corrected progesterone.

      AUC0-last (the area under the plasma concentration-time curve): The 90% confidence interval
      for this measure lies within an acceptance range of 80.00% - 125.00% based on corrected
      Progesterone.

      ▲Based on Cmax CVR% (Coefficient of Variation Ratio )=50.97% the calculated confidence
      interval acceptance limits were (69.83%-143.19%)
    

Intervention name(s): Progesterone 200 mg Soft Capsule (JSC "Farmak", Ukraine); Utrogestan® 200 mg Soft Capsule (Manufacturer by: Cyndea Pharma, S.L., Spain, MAH: Laboratoires Besins International, France)
Intervention type(s): Drug; Drug
Intervention description(s): Orally, with 240 mL of water at dosing in sitting position; Orally, with 240 mL of water at dosing in sitting position
Other intervention name(s): Injesta; Utrogestan®
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Comparative, Randomized, Two-Sequence, Two-Treatment, Four-Period, Open-Label, Single oral Dose, Fully Replicated, Crossover bioequivalence Study
Masking: None (Open Label)
Primary purpose: Other
Keywords: bioequivalence; pharmacokinetics; generic drugs; Progesterone; Soft Capsule; oral dosage form