bioihbjkbjnl/mcl2 huggingface dataset:
Effect of 6 Weeks of Whole-body Vibration in Treatment of Postnatal Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      Background: Postpartum constipation is a common problem affecting postpartum mothers. Aim: To
      determine whether Whole Body Vibration is effective in treatment of postnatal women
      constipation. Design: The study was designed as a prospective, randomized, single-blind,
      pre-post-test, controlled trial.

      HYPOTHESES:

      It will be hypothesized that:

      It was hypothesized that whole-body vibration has no or limited effect in treatment of
      postnatal constipation RESEARCH QUESTION: Does whole-body vibration has an effect in
      treatment of postnatal constipation?
    

Detailed description: 
      Methods: Group A received whole-body vibration, pelvic floor exercise and static abdominal
      exercises interventions for six weeks and group B received pelvic floor exercises and static
      abdominal exercises in addition to diet instructions in both groups. Constipation symptom
      questionnaire and patient assessment of constipation quality of life questionnaire is applied
      before and after treatment.
    

Intervention name(s): Whole Body Vibration; pelvic floor exercises and static abdominal exercises in addition to diet instructions
Intervention type(s): Combination Product; Other
Intervention description(s): vibration was administered for 1min, with a rest interval of 1min between each vibration set repeating 10 vibrations, with a frequency of 30 Hz and an amplitude of 0-2 mm and a speed of 50 m /s,18 and these sessions lasted for 6 weeks 3 days a week. whole-body vibration was induced by a noninvasive oscillation platform; During the low abdominal hollowing with instructed pelvic floor co-contraction test subjects were instructed with the standard command: 'Breathing normally, and keeping your back still, gently lift and tighten your pelvic floor. Now gently draw in your low tummy as well and hold it'. Pelvic floor facilitates transversus abdominis thickness.
subject in supine lying with her arms crossed over the diastasis for support. And subject has to draw or pull the abdomen inwards so that there elicits an isometric contraction of abdominal muscles and repeated this for 5-7 times.
Other intervention name(s): pelvic floor exercises and static abdominal exercises in addition to diet instructions only
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Whole Body Vibration; Postnatal women
Drug-Drug Interaction Study of VCH-222 and Telaprevir in Healthy Subjects
Condition: Hepatitis C
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the pharmacokinetics, safety, and tolerability of
      the co-administration of VCH-222 and telaprevir in healthy subjects.
    


Intervention name(s): VCH-222; VCH-222; VCH-222; telaprevir
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Capsules, Oral, 400 mg, q12h, Days 1-10 and Days 28-37; Capsules, Oral, 750 mg, q12h, Days 1-10 and Days 28-37; Capsules, Oral, 1000 mg, q12h, Days 1-10 and Days 28-37; Tablet, Oral, 1125 mg, q12h, Days 18-37
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: VX-950; VX-222; STAT-C
The Role of Epigenetics in Inner City Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      As part of ongoing efforts to determine the causes of asthma and the progression of the
      disease, this study will gather data to explore the interaction of genetic and environmental
      factors in the cause and severity of asthma in inner city children.
    

Detailed description: 
      Asthma is a complex, heritable disease that affects more than 11.2% of the U.S. population,
      which represents approximately 9 million children and 23 million adults. It is thought that
      asthma may be caused by the interaction of multiple genetic factors, such as whether a parent
      or sibling has asthma, and environmental factors, such as living in an inner city. Studying
      DNA from people who have asthma and those who do not have asthma may help us better
      understand the importance of those genes and how they are involved in asthma severity and
      response to treatment.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Black inner city children with:1.)persistent asthma and 2.) without asthma.
      
Biospecimen description: 
      DNA, RNA, serum, and plasma specimens
Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study One
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 study was to establish the efficacy and safety of alemtuzumab (Lemtrada™)
      as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with
      subcutaneous (SC) interferon beta-1a (Rebif®). The study had enrolled participants who had
      not previously received MS disease-modifying therapies. Participants had monthly laboratory
      tests and comprehensive testing every 3 months.
    

Detailed description: 
      Every participant had received active treatment; there was no placebo. Participants who
      qualified were randomly assigned to treatment with either alemtuzumab or SC interferon
      beta-1a at a 2:1 ratio (that is, 2 given alemtuzumab for every 1 given interferon beta-1a).
      Alemtuzumab was administered in two annual courses, once at the beginning of the study and
      again 1 year later. Interferon beta-1a was self-injected 3 times per week for 2 years. All
      participants were required to return to their study site every 3 months for neurologic
      assessment. In addition, safety-related laboratory tests were performed at least monthly.
      Participation in this study ended 2 years after the start of treatment for each participant.
      Additionally, participants who received alemtuzumab might be followed in CAMMS03409
      (NCT00930553) an extension study for safety and efficacy assessments. Participants who
      received interferon beta-1a and completed 2 years on study might be eligible to receive
      alemtuzumab on the extension study.
    

Intervention name(s): Alemtuzumab; Interferon beta-1a
Intervention type(s): Biological; Biological
Intervention description(s): Alemtuzumab 12 milligram (mg) per day intravenous (IV) infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.; Interferon beta-1a 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
Other intervention name(s): Lemtrada; Rebif®
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a; Alemtuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Sclerosis
Breastfeeding Improvement Following Tongue-tie and Lip-tie Release
Condition: Ankyloglossia; Breastfeeding
MeSH terms: Ankyloglossia
Study type: Interventional

Summary: 
      This study is an observational study to determine outcomes of surgical release of tongue-tie
      and lip-tie in babies who are experiencing difficulty with breastfeeding.
    

Detailed description: 
      Breastfeeding rates in the United States initiate at around 80%, but many mothers are unable
      to effectively breastfeeding because of problems with latch and suction generation. Previous
      studies have demonstrated how nipple pain is directly linked to ankyloglossia, but most of
      these studies are done with poor methodology.

      Clinically, tongue-tie and lip-tie have correlate with numerous other symptoms besides nipple
      pain. These babies tend to be inefficient nursers, which can affect weight gain. Abnormal
      intake of air because of the poor latch/seal can lead to reflux symptoms. Finally, there is a
      significant psychological toll on mothers who want to breastfeed but cannot do so.

      This study aims to prospectively analyze these outcomes by using validated tools.
    

Intervention name(s): Lingual Frenotomy and/or maxillary labial frenectomy
Intervention type(s): Procedure
Intervention description(s): The procedure is performed with a 1064nm InGaAsP semiconductor diode laser which is a soft tissue laser with variable pulsed wave and wattage settings. The procedure was performed at 0.7-0.8 pulsed watts, 200 microseconds on and 100 microseconds off (actual wattage: 0.47 to 0.53 W) using a 300 micron laser fiber. The tongue is elevated using a grooved director while the laser tip is applied to the frenulum. If present, the anterior frenulum is divided until the submucosal portion of the tie is identified (this is the posterior tongue-tie). A small window in the central mucosa is made and the lateral mucosal walls of the posterior tongue-tie are released, taking care to not disturb the fascia of the underlying genioglossus muscle.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cysteamine for Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see if a medicine called Cysteamine, given along with
      standard asthma care, will improve asthma symptoms and lung function.
    

Detailed description: 
      Asthma affects 25.7 million people in the US. Many people report symptoms despite taking
      high-doses of inhaled asthma medications. This difficult-to-treat group accounts for more
      than 50% of asthma related healthcare visits and hospitalizations. The purpose of this study
      is to see if a medicine called Cysteamine, given along with standard asthma care, will
      improve asthma symptoms and lung function.

      This study is a double-blind, placebo-controlled, randomized trial of cysteamine. A placebo
      arm will be included to determine the comparative effectiveness of cysteamine in this
      population. Eligible participants will be assessed 1, 4 and 8 weeks post randomization and
      followed for an additional 4 weeks post treatment.

      In order to enroll in this study, participants must be between the ages of 18-45 and have
      uncontrolled asthma.

      This study will include 4 visits and weekly phone calls, and will be in the study for 3-4
      months.

      During the treatment period, participants will be placed in one of two treatment groups:

        -  Cysteamine

        -  Placebo

      Participants will not be able to choose which group they are assigned. This assignment is
      random and by chance, much like flipping a coin. Participants will not know if they are
      receiving Cysteamine or placebo. Investigators will compare the study results between the
      participants of each group.
    

Intervention name(s): Cysteamine Bitartrate; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Cysteamine bitartrate administered four times per day (QID) for 8 weeks. 125mg tablet QID.; Placebo administered for 8 weeks. 125mg tablet QID.
Intervention MeSH terms: Cysteamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1:1 randomized, double-blind, placebo-controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Adaptive Interventions for Prevention/Intervention for Youth Substance Abuse
Condition: Substance Use
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The main aim of this formative study is to test and iteratively refine a new mobile phone
      app, which delivers assessments and tailored intervention content. The study will use social
      media advertisements to recruit a total of 40 youth between the ages of 16-24 years. Those
      screening positive for past-month binge drinking or marijuana use will be invited to complete
      a baseline survey, download and use the app for 30 days, and complete a follow-up survey
      about the app functionality, design and content, and preliminary outcomes (intentions and
      importance of reducing use).
    

Detailed description: 
      Previously, the study team developed a prototype mobile application which utilized novel
      engagement strategies to enhance user adherence with daily and weekly survey assessments. The
      new app developed for this study extends the previous app by featuring the capability to also
      deliver tailored health intervention. As part of the app, users are prompted to complete
      brief daily and weekly assessments for 30 days. For each completed assessment, users earn
      small financial rewards and points to unlock new fish that populate a virtual aquarium in the
      app. The app also features push notifications with survey reminders and life insights (or
      graphs plotting data collected over time) to increase user engagement with the app.
      Additionally, each day, users are randomized to receive intervention content (see the
      "Interventions" section for more information) tailored on their recent assessment responses.
      After 30 days of using the app, participants will be asked to complete a follow-up survey;
      data collected will provide preliminary feedback regarding the feasibility and effectiveness
      of using the app to deliver substance use intervention content to affected youth.
    

Intervention name(s): Push Notifications with Tailored Intervention Content; Push Notifications with Engaging, Non-therapeutic Content; No Push Notifications
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will receive a push notification with a therapeutic message (e.g., about stress, mood, substance use motives, tools to reduce risky substance use) tailored to their recent daily or weekly survey responses. Messages include visual (memes, images, videos) and written content.; Participants will receive a push notification with an engaging, non-therapeutic message (e.g., fun facts).; Participants will not receive a push notification.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: substance use; mobile health
Phase I, Escalating, Multiple-Dose, ST-246 Safety, Tolerability and Pharmacokinetics 21-Day Trial in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of a
      single, daily, oral dose of ST-246 (either 250, 400 or 800mg) administered for 21 days to 30
      healthy, fed volunteers.
    

Detailed description: 
      This was a double-blind, placebo-controlled, dose-escalating, multiple-dose study of orally
      administered ST-246 to 30 healthy volunteers ages 18-50 years, randomized to receive either
      active drug (8 subjects) or placebo (2 subjects) in 1 of 3 dosing groups (250, 400 or 800mg
      groups). Each dose group of 10 was divided into two cohorts of 5 subjects (4 active and 1
      placebo). The first cohort was dosed approximately 4-8 weeks before the second cohort of each
      dose group. Dose groups completed the study treatment approximately 5 weeks prior to the
      start of the following dose group. Study procedures included several overnight stays, medical
      history/exam, laboratory testing done by blood draw, and electrocardiograms.
    

Intervention name(s): ST-246; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 250 mg, 400 mg or 800 mg capsules given once daily for 21 days; Capsules to match experimental drug
Other intervention name(s): Tecovirimat; Placebo to match ST-246
Intervention MeSH terms: Tecovirimat
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy Volunteers
Telerehabilitation in COVID-19 Survivors
Condition: COVID-19; Telerehabilitation
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      This study was carried out in the post-acute period of the telerehabilitation program in
      individuals with dyspnea who had COVID-19; It will be done to examine the effects on dyspnea,
      exercise capacity, respiratory functions, activities of daily living, muscle strength, muscle
      oxygenation, fatigue and quality of life parameters.
    


Intervention name(s): telerehabilitation; home exercise program; informed program
Intervention type(s): Other; Other; Other
Intervention description(s): While telerehabilitation sessions will be applied to the participants in the telerehabilitation group for 6 weeks, home exercise program will be given to the home exercise program group and will be applied for 6 weeks.; While telerehabilitation sessions will be applied to the participants in the telerehabilitation group for 6 weeks, home exercise program will be given to the home exercise program group and will be applied for 6 weeks.; will informed after COVID 19
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: COVID-19; telerehabilitation; COVID-19 Survivors; functional capacity; pulmonary functions; peripheral muscle oxygenation; home workout program
A Drug to Drug Interaction Study of Sotagliflozin With Midazolam and Metoprolol
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To assess the effect of repeated once-daily oral doses of sotagliflozin on CYP2D6 and CYP3A
      activities using a CYP probe cocktail of metoprolol and midazolam.

      Secondary Objective:

      To assess the clinical and laboratory safety of sotagliflozin coadministered with the
      cocktail probes as compared to that of cocktail probes alone.
    

Detailed description: 
      The total study duration per subject is up to 58 days.
    

Intervention name(s): sotagliflozin (SAR439954); midazolam; metoprolol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: tablet
Route of administration: oral; Pharmaceutical form: HCl syrup
Route of administration: oral; Pharmaceutical form: tablet
Route of administration: oral
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol; Metoprolol; Midazolam
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Determine the Tolerability, Safety and Pharmacokinetics of Ketorolac Tromethamine by Intranasal Administration in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a phase 1, open label, multiple dose study in healthy male and female volunteers.
      Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for
      three days (seven doses in total). Doses were administered every eight hours.

      The objective of this study in healthy volunteers was to determine the safety, tolerability,
      and pharmacokinetics of multiple doses of intranasal ketorolac tromethamine.
    


Intervention name(s): Ketorolac tromethamine
Intervention type(s): Drug
Intervention description(s): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Stretching of the Diaphragm and Cervical Impulse Technique and Its Possible Spirometric Changes
Condition: Respiratory Disease
MeSH terms: Respiratory Tract Diseases; Respiration Disorders
Study type: Interventional

Summary: 
      This study investigates the effect of two different techniques, stretching of the diaphragm
      and cervical level impulse technique C3-C4, in the possible spirometric changes, vital
      capacity (CV), maximum expiratory flow (PEF) and maximum expiratory volume (FEV). in relation
      to the secondary variables (age, physical activity, BMI, sex). the subjects of the study were
      informed and clarified doubts about it and its subsequent reading and signing of informed
      consent. The subjects were randomly selected to determine which intervention group they would
      belong to (G1: intervention group of the diaphragm muscle stretch technique, G2: intervention
      group of the cervical rotation rotation impulse technique C3- C4, G3: Combined technique G1
      and G2, G4: control group.The evaluation technique is spirometry.The intervention protocol is
      as follows, first the pre-intervention spirometry is performed, then the corresponding
      technique (according to intervention group), then the post-intervention spirometry, the
      intervention technique and at 5 minutes, the intervention technique is performed.
    

Detailed description: 
      The objectives of the study are the following: 1. To evaluate the changes in the values of
      the simple spirometry after the application of the study techniques: muscle stretching
      technique of the diaphragm (G1), rotation impulse technique of the cervical level of C3- C4
      (G2) and combined technique of both (G3); 2. Determine the influence of these on measurable
      respiratory parameters by simple spirometry; 3. Compare the spirometric values obtained after
      applying the study techniques (G1, G2, G3) and the control group (G4: simulation of a
      previous technique); and 4. Analyze the different variables measured (age, gender, weight,
      height, sports practice and body mass index) in the effects of the applied treatment.
    

Intervention name(s): Stretching the diaphragm muscle; Impulse technique in rotation of cervical level 3 and 4; Combined technique of diaphragm muscle stretch and cervical rotation impulse technique level 3 and 4
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Place the hands on the last costal cartilages and maintain the ascent of the ribs in the expiration.; head to double chin position and then placed with neutral flexo-extension until focusing on the level of manipulation, ipsilateral lateral flexion and contralateral rotation approximately 45 degrees.; The same initial position, hand placement and technique guidelines will be used, cited in each of the techniques performed in the "intervention 1" group and the "intervention 2" group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diaphragm; Neck; Frenic Nerve