bioihbjkbjnl/mcl2 huggingface dataset:
Metabolic Adaptations in Response to High Intensity Interval Training in Obese Adults
Condition: Glucose Intolerance
MeSH terms: Glucose Intolerance
Study type: Interventional

Summary: 
      The overall objectives are to:

        1. Assess mechanisms underlying HIIT-induced improvements in insulin resistance at the
           whole-body, tissue, and cellular levels.

        2. Systematically compare different HIIT regimens to help identify effective "doses" of
           HIIT that may be optimal for improving metabolic health in obese adults.

        3. Assess the ability/willingness of obese subjects to adhere to a long-term HIIT program.

      Findings from these studies will greatly expand knowledge about the effects of HIIT on
      metabolic health, and will provide valuable information for development of programs aimed at
      maximizing key metabolic benefits of exercise.
    

Detailed description: 
      If subjects are eligible for the study, they will be randomized into one of four different
      exercise training groups. Before training (and twice after 3 months of training) subjects
      will participate in a "clinical study" in which they will be required to stay overnight in
      the hospital. During the clinical study, the research team will perform a series of metabolic
      tests. Before and after the 3 months of training, the research team will assess subjects
      "free-living" 24h blood sugar control using a Continuous Glucose Monitor (CGM). The research
      team will measure several other relevant clinical markers (e.g., whole body and regional body
      fat assessments [Dual Energy X-ray Absorptiometry (DEXA) and Magnetic Resonance Imager
      (MRI)], hepatic lipid accumulation [MRI analysis], blood lipid profile, resting metabolic
      rate, glycated hemoglobin [hemoglobin A1c]). After the first 3 months of training, adherence
      to the subjects assigned training program will be tracked for the next 9 months (1 year of
      training in total). One year after initiating a training program, subjects will be asked to
      return to the clinic for a quick follow-up visit where the research team will complete some
      standard clinical assessments (e.g., body weight, body composition, blood pressure, and a
      blood sample).
    

Intervention name(s): High Intensity Interval Training #1; Moderate intensity continuous training; High Intensity Interval Training #2; High Intensity Interval Training #3
Intervention type(s): Other; Other; Other; Other
Intervention description(s): (HIIT#1) 10 x 1 min. at ~90%HRmax - with low intensity warm-up, recovery, and cool down - total of 25 min/session .; Moderate-intensity continuous training (MICT) = steady-state exercise at 60-70%HRmax for 45min. Representing a commonly prescribed exercise program.; (HIIT #2) 5 x 1 min at 90%HRmax + 10 min steady-state exercise at 70%HRmax [25min; ~150kcals; 4d/wk]; (HIIT #3) 5 x 1 min at 90%HRmax [15min; ~90kcals; 4d/wk]
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study to Evaluate the Safety and Effectiveness of Intravitreal Injections (IVI) of Brolucizumab in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Condition: Neovascular Age-related Macular Degeneration (nAMD)
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to generate additional safety and effectiveness data in Indian
      neovascular age-related macular degeneration (nAMD) patients that more closely resemble the
      real-world population intended to be treated with brolucizumab. This study is being conducted
      as part of the post-marketing regulatory commitment to the Indian Health authority.
    

Detailed description: 
      This is a prospective, multi-center, open-label, interventional phase IV clinical study. The
      study treatment i.e. brolucizumab will be prescribed in terms of the marketing authorization;
      the assignment of the patient to the therapy will be decided within the current practice and
      the medical indication, and will clearly be separated from the decision to include the
      patient in the study.

      All patients with nAMD who are planned to be treated with brolucizumab and have provided
      informed consent may be enrolled in this study. The treatment period for each patient will be
      56 weeks after the start of brolucizumab treatment. Study visits will be scheduled at week 4,
      week 8, week 16, and thereafter at intervals of 8 weeks or 12 weeks after disease activity
      assessment at week 16. If the investigators require more frequent follow-up visits, it can be
      done according to their discretion and clinical judgment. Any patient who suffers from
      intra-ocular inflammation (IOI) during the study period would not be re-challenged with
      brolucizumab.

      Data originating from assessments and evaluations performed will be collected from the
      patient's medical records at Baseline (BL), i.e. start of brolucizumab treatment, week 4,
      week 8, week 16, week 20, week 24, week 32, week 40, week 44, week 48 and at week 56.
    

Intervention name(s): Injection Brolucizumab
Intervention type(s): Biological
Intervention description(s): Single-chain antibody fragment (scFv)
Brolucizumab 6 mg will be administered by IVT injection as per the Prescribing information (PI) and in line with the treating physician's clinical judgement. Patients will receive loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) will be performed based on BCVA and OCT to assess whether the patient will require q8w or q12w dosing.
Other intervention name(s): Trade Names: Pagenax, Beovu, Vsiqq
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Macular degeneration; age-related macular degeneration (ARMD); vision loss; macula damage; retina damage; dry macular degeneration; wet macular degeneration; Subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration
Dyspnea in COPD: Relationship With Exacerbations Frequency
Condition: Dyspnea
MeSH terms: Dyspnea
Study type: Interventional

Summary: 
      The perception of breathlessness varies significantly among COPD patients with similar
      severity of airflow limitation; those with poorer perception report less exacerbations as
      compared to those with frequent exacerbations.

      Cross-sectional comparison of breathlessness perception in COPD patients with frequent
      exacerbations or without frequent exacerbations.

      To assess "Breathlessness Perception" the investigators will increase the ventilatory demand
      of the patients by CO2-rebreathing method.
    

Detailed description: 
      The perception of breathlessness varies between individuals. This is a well-established
      concept in asthma, but mostly unexplored in COPD; the relationship between airflow limitation
      (FEV1, % ref.) and breathlessness (mMRC) is weak.

      The perception of breathlessness varies significantly among COPD patients with similar
      severity of airflow limitation; those with poorer perception report less exacerbations as
      compared to those with frequent exacerbations.

      It is a cross-sectional comparison of breathlessness perception in COPD patients with
      frequent exacerbations (≥2 or ≥1 with hospitalization in the previous year) or without
      frequent exacerbations (0 or 1 without hospitalization in the previous year).

      To assess "Breathlessness Perception" the investigators will increase the ventilatory demand
      of the patients by CO2-rebreathing method. CO2 rebreathing test will be conducted to evaluate
      the acute ventilatory response to CO2 inhalation used to estimate central chemoreceptor
      responsiveness in patients with the obstructive pulmonary disease.

      Simple descriptive statistics (unpaired T-test) and correlation analysis (bivariate and
      multivariate) will be used to analyze results.
    

Intervention name(s): Spirometry; CO Exhaled breath; P01; FeNO
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): Before re-breathing (if the patient not performed one 6 months in advance).; In current smokers of both arms to confirm that the patient has not smoked in the past three hours and to asses the smoking status (heavy, moderate, light).; P01 is the negative airway pressure generated during the ﬁrst 100 ms of an occluded inspiration. It's an estimation of the neuromuscular drive to breathe.; The measurement of fraction of exhaled nitric oxide during exacerbations of COPD is higher than normal.
Other intervention name(s): FEV1; FVC; FEV1/FVC; VC; TLC; Rwc; DLCO; DLCO/VA; Ventilation (VE); Inspiratory capacity (IC); CO (ppm); COHb (%)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Dyspnea perception; COPD; Exacerbations; CO2 rebreathing test
Desogestrel-containing COCP Pharmacokinetic Validation Study
Condition: Contraception
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to validate prior pharmacokinetic research with combined oral contraceptive
      pill users that supports utilizing a 24-hour trough concentration as an accurate proxy for
      the intensive pharmacokinetic parameter of area under the curve (gold standard
      pharmacokinetics). The original pharmacokinetic studies were performed with a
      levonorgestrel-containing oral contraceptive pill and we aim to duplicate those findings with
      a desogestrel-containing oral contraceptive pill.
    

Detailed description: 
      Enrolled participants will be started on a standard pack of desogestrel-containing oral
      contraceptive pills and undergo an intensive pharmacokinetic study visit on day 21 of the
      pill pack. This will entail 11 serial blood draws and a final blood draw the next day at 24
      hours post-pill intake to measure and calculate a pharmacokinetic area under the curve for
      both the estrogen and progestin components of the pill. We will then correlate the 24-hour
      trough measurement to the area under the curve measures to determine the correlation of these
      measurements.
    

Intervention name(s): Desogestrel and Ethinyl Estradiol Tablets
Intervention type(s): Drug
Intervention description(s): Combined oral contraceptive pill
Intervention MeSH terms: Ethinyl Estradiol; Desogestrel; Estradiol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9933 in Adult Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the safety and tolerability of single doses
      of REGN9933 in healthy participants

      The secondary objectives of the study are to:

        -  Evaluate the effects of single doses of REGN9933 on intrinsic/common pathway coagulation

        -  Evaluate the effects of single doses of REGN9933 on extrinsic/common pathway coagulation

        -  Characterize the drug concentration profiles and pharmacokinetic (PK) following single
           escalating doses of REGN9933

        -  Characterize the concentration profiles of total FXI following single escalating doses
           of REGN9933

        -  Assess the immunogenicity of single doses of REGN9933
    


Intervention name(s): REGN9933; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered intravenously (IV) or subcutaneous (SC) per the protocol; Placebo to match REGN9933 in same form; placebo administered IV or SC per the protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HV
MRI Study of Tic Remission in Tourette Syndrome
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Study type: Observational

Summary: 
      Doctors provide a ray of hope to children and their parents with the knowledge that, for most
      patients, symptoms of Tourette syndrome improve by the time they are young adults. The
      investigators do not know why some improve and others do not. This study is designed to help
      answer that question. The investigators will use magnetic resonance imaging (MRI) techniques
      to test whether individuals who experience improvement of their Tourette's (tic remission)
      have more mature brain connections than those who do not.
    

Detailed description: 
      One of the most interesting aspects of Tourette syndrome is a virtual remission of tics by
      early adulthood in about half of patients. Information is needed to clarify the mechanism of
      tic remission in order to guide development of better treatments for this disabling
      condition. For this cross-sectional study, 10 individuals with tic remission and 10
      individuals with persistent Tourette syndrome are being recruited for a one-time study visit.
      10 neurologically normal (non-TS) controls have also been recruited to obtain control
      neuroimaging data. All participants will complete a study questionnaire and a 60-minute MRI
      procedure. Sequences used to compare the groups will be volumetric, diffusion tensor, resting
      state functional connectivity MRI and MR spectroscopy. Our primary hypothesis is that the
      pattern of functional connectivity in individuals with tic remission will be more mature than
      that of those with persistent tics. Secondary hypotheses tested will explore whether the
      other modalities can be used to differentiate tic remission from persistent TS.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Young adult males (aged 18-35) with a history of Tourette syndrome, including at least
        moderate disability from tics during childhood.
      
Keywords: Tourette; tic; Tourette's; Tourette syndrome; Tourette's syndrome
Supported Employment Demonstration
Condition: Mental Impairment
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether offering an evidence-based package of
      employment supports integrated with mental health services has a positive impact on
      employment and clinical recovery, and delays or diminishes the need for disability benefits.
    

Detailed description: 
      SSA contracted with Westat to implement and evaluate the Supported Employment Demonstration
      (SED). The SED provides integrated mental health and vocational services to people with
      mental illness who were recently denied Social Security disability benefits. The evaluation
      will determine the impact of the SED on employment, clinical recovery, and receipt of
      disability payments. The evaluation is using a randomized controlled trial design to compare
      the outcomes of two treatment groups and a control group. In the full-service arm (n =
      1,000), participants receive services from an Individual Placement and Support employment
      specialist, a care manager, and a nurse care coordinator (NCC) who provides medication
      management support, as well as modest funding for out-of-pocket prescriptions, essential
      work-related expenses, and other services in the participant's treatment plan. The
      basic-service arm (n=1,000), which is expected to cost about 50 percent less than the
      full-service arm, provides all services and funds except the NCC. Participants in the usual
      services (control) group (n = 1,000) seek services as they normally would but receive a
      comprehensive guide to local, state, and national resources.

      Data collection includes computer-assisted baseline (in-person) and blinded quarterly
      (telephone) interviews with participants, collection of SSA administrative and site-level
      program data, site visits (including fidelity assessments), qualitative interviews with site
      administrators and service providers, focus groups with study participants, and
      person-centered ethnographic interviews with participants and nonparticipants.
    

Intervention name(s): Full Service; Basic Service
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Receive Individual Placement and Support (IPS) model of employment services, behavioral health services, care management services, and Medication Management Support provided by a Nurse Care Coordinator (NCC).; Receive Individual Placement and Support (IPS) model of employment services, behavioral health services, and care management services.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Glycemic and Insulinemic Response to Oats Soaked Overnight in Milk Compared to Cream of Rice in Healthy Subjects
Condition: Glycemic, Insulinemic, Subjective Appetite Responses
Study type: Interventional

Summary: 
      One objective of this study is to examine the blood glucose and serum insulin responses over
      2hr elicited by oats soaked overnight in milk compared to Cream of Rice soaked overnight in
      milk and compared to Cream of Rice cooked in water. In addition a second objective of the
      study is to measure subjective ratings of hunger and fullness under the same conditions.
    


Intervention name(s): Cereal - oats; Cereal - cream of rice
Intervention type(s): Other; Other
Intervention description(s): Consumption of one cereal in the beginning of each visit; Consumption of one cereal in the beginning of each visit
Other intervention name(s): Oats; Cream of Rice
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
VX-950-C211 - A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naïve Participants With Genotype 1 Chronic Hepatitis C Virus Infection
Condition: Genotype 1 Chronic Hepatitis C; Treatment Naive
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Virus Diseases; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effectiveness of telaprevir administered twice
      daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in
      treatment-naïve participants with chronic HCV genotype 1 infection.
    

Detailed description: 
      This is a randomized (study drug assigned by chance), open-label (all persons know the study
      drug assignment) multicenter study to evaluate the effectiveness of telaprevir administered
      orally as 1125 milligram (mg) twice daily versus 750mg every 8 hours in combination with
      Peg-IFN-alfa-2a, administered via intramuscular injection once a week, and ribavirin,
      administered as an oral tablet twice a day, in treatment-naïve study participants with
      chronic hepatitis C virus (HCV) genotype 1 infection.

      Telaprevir will be given orally (by mouth) from Day 1 through Week 12 as 3 tablets (1125mg)
      twice daily or 2 tablets (750mg) every 8 hours. Peg-IFN-alfa-2a will be administered once a
      week as an injection under the skin (180 microgram/week) from Day 1 through Week 24 or 48
      (based on the patient's treatment response on week 4). Ribavirin is administered orally (by
      mouth) twice daily from Day 1 through Week 24 or 48 (based on the participant's treatment
      response on week 4) as 1,000-1,200 mg per day. After the end of treatment (Week 24, Week 48,
      or at early discontinuation of all study drugs), participants with undetectable HCV RNA at
      end of treatment will be required to attend follow-up visits until Week 72
      safety/tolerability assessments will be performed throughout the treatment period and during
      the follow-up period.
    

Intervention name(s): Ribavirin; Telaprevir; Pegylated interferon alfa-2a; Telaprevir
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Ribavirin (RBV) 1000-1200 milligram (mg) per day (weight dependent) twice daily regimen oral tablets for 24 or 48 weeks depending on the patient's treatment response at week 4; 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks; 180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks Pegylated interferon alfa-2a 180 microgram (µg) per week subcutaneous injection for 24 or 48 weeks depending on the patient's treatment response at week 4; 750 mg (2 oral tablets) every 8 hours for 12 weeks
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Genotype 1 chronic hepatitis C; VX-950-C211; VX-950; IL28B; Telaprevir; Hepatitis C; BID; Q8h; SOC
Biomarker Testing and DNA Collection in Subjects Participating in Protocol 22001
Condition: Fragile X Syndrome
MeSH terms: Fragile X Syndrome; Syndrome
Study type: Observational

Summary: 
      The subjects that meet the inclusion and exclusion criteria and consent to participate in
      protocol 22001 will be offered participation in 22001A which will evaluate secreted protein
      before and after treatment with STX209 and placebo to determine if they correlate with
      effectiveness of treatment or susceptibility to treatment with STX209. These same subjects
      will also be asked to contribute a blood sample for DNA (deoxyribonucleic acid) collection.
      The investigators will study the DNA to determine if STX209 works better in people with
      specific gene variations, or to find new gene variations that predict how well STX209 works.
    


Intervention name(s): STX209
Intervention type(s): Drug
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Fragile x syndrome subjects that meet the inclusion and exclusion criteria and consent to
        participate in protocol 22001
      
Biospecimen description: 
      DNA from blood,plasma
    
Keywords: fragile X syndrome; biomarkers