bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Dietary Salt on Post-exercise Hypotension
Condition: Blood Pressure; Post-Exercise Hypotension
MeSH terms: Post-Exercise Hypotension; Hypotension
Study type: Interventional

Summary: 
      The new American Heart Association (AHA) blood pressure guidelines are expected to raise the
      prevalence of high blood pressure to ~46% in the United States. One recommendation for
      lowering blood pressure is aerobic exercise, which produces a period of lowered blood
      pressure (post-exercise hypotension; PEH) that lasts up to 24 hours. It is believed that PEH
      may be responsible for the observations of lowered blood pressure following initiation of
      exercise. However, most Americans eat too much salt, which expands plasma volume and may
      prevent PEH, rending aerobic exercise ineffective in improving blood pressure status.
    

Detailed description: 
      Recently released blood pressure guidelines from the American Heart Association and American
      College of Cardiology are expected to raise the prevalence of hypertension in America from
      ~33% to ~46%. A single bout of aerobic exercise produces a prolonged period (up to 24 hours)
      of lowered blood pressure (post-exercise hypotension; PEH). Repeated bouts of aerobic
      exercise results in maintenance of lowered blood pressure, leading to recommendations of
      aerobic exercise for improvement of blood pressure status. However, more than 90% of
      Americans consume more sodium in their diets than is recommended. This is alarming, as excess
      dietary sodium intake expands plasma fluid volume, which may in turn attenuate the reduction
      in BP following exercise. Therefore, the objective of this project is to determine the
      effects of high dietary sodium intake on PEH. The investigators hypothesize that, compared to
      a recommended sodium diet, a high salt diet will attenuate post-exercise hypotension.
    

Intervention name(s): High dietary salt; Placebo
Intervention type(s): Other; Other
Intervention description(s): ~4,000 mg Na+/day; dextrose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Study to Evaluate Antiviral Activity, Safety, and Pharmacokinetics of Repeated Doses of Orally Administered JNJ 53718678 Against Respiratory Syncytial Virus Infection.
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the antiviral effect of repeated oral dosing of JNJ
      53718678 compared to placebo in healthy adult participants infected through inoculation with
      respiratory syncytial virus (RSV)-A Memphis 37b virus.
    

Detailed description: 
      This is a randomized (study medication assigned to participants by chance), double-blind
      (neither physician nor participant knows the identity of the assigned treatment),
      placebo-controlled, single-center study of JNJ 53718678 in healthy adult participants. Study
      consists of 3 phases: Screening (Day -56 and Study Day -3 prior to the planned date of virus
      inoculation/challenge on Study Day 0), quarantine (includes challenge on Day -1 or -2 and
      treatment for 7 days), and follow-up (Day 15 and 28). Participants will be admitted to the
      quarantine unit on Study Day -1 or - 2 and will be inoculated (intranasal) with the RSV-A
      Memphis 37b virus on Study Day 0. Participants will be evaluated in 3 cohorts: Cohort 1 and
      Cohort 3 (participants will be dosed with JNJ-53718678 or placebo for 7 days) and Cohort 2
      (for up to 7 days [Dosing Days 1-x] [x will be determined based on the results from Cohort
      1]). Participants will be randomized and JNJ-53718678/placebo dosing will be started after
      RSV presence in nasal wash has been detected by polymerase chain reaction (PCR). After
      completion of Cohort 1, data will be reviewed (unblinded) and the antiviral activity, safety,
      pharmacokinetic, clinical symptom and mucus weight data will be evaluated, based on which
      Cohort 2 will be initiated. Participants' safety will be monitored throughout the study.
    

Intervention name(s): Placebo; JNJ-53718678
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive placebo once daily.; Participants will receive JNJ-53718678 as 20 milliliter (mL) (200 mg) or 50 mL (500 mg) oral solution (containing 10 mg JNJ-53718678 per mL) in Cohort 1. JNJ-53718678 dose in Cohort 2 will be decided based on Cohort 1 results. JNJ-53718678 as 7.5 mL (75 mg) oral solution (containing 10 mg JNJ-53718678 per mL) in Cohort 3.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Respiratory Syncytial Virus Infections; Placebo; Antiviral activity; JNJ-53718678
Effectiveness of a Treatment With the Robot - Assisted Gait Training System Walkbot in Patients With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The improvement of walking capacity is a key objective of the rehabilitation of children with
      PC. There are different approaches from physiotherapy to address this need, including walking
      on the ground and on treadmill with partial weight support. Currently, there are robotic
      technologies adapted to the functional rehabilitation of patients. Assisted gait training
      with robotic devices such as the Walkbot allows a longer duration of training, at more
      variable speeds, and with a constant gait pattern adapted to the patient. This training,
      based on the intensity and repetition of the movement, has beneficial effects on the recovery
      and improvement of the patient's postural and locomotor functions.

      There are some studies that evaluate walking interventions on treadmill with partial weight
      support, on the ground and in assisted walking robot in patients with PC.

      Currently, there are no studies conducted that report the effectiveness of interventions
      performed with robotic walking training device Walkbot K on PC. However, studies in adults
      with Walkbot S, affected with neurological injury, have reported good results.

      Assisted gait training with robotic devices such as the Walkbot, based on the intensity and
      repetition of the movement, has beneficial effects on the recovery and improvement of the
      patient's postural and locomotor functions. However, due to the little evidence that exists,
      it is necessary to know the effectiveness of the Walkbot assisted walking robot in these
      patients by means of a clinical trial that allows to firmly establish the scope of its
      benefits.
    


Intervention name(s): Assisted gait training with Walkbot System; Physical Therapy
Intervention type(s): Device; Other
Intervention description(s): The experimental group will receive at least 3 treatment sessions per week consisting of 40 minutes in robot-assisted gait training with Walkbot System in addition to their usual Physical therapy sessions. In total, the number of Walkbot sessions will be 20, in uninterrupted weeks.; The control group will receive their usual Physical therapy sessions during 6 weeks.
Other intervention name(s): Physical Therapy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
UCN-01 and Topotecan in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer
Condition: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer
MeSH terms: Fallopian Tube Neoplasms; Peritoneal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Topotecan may stop the growth of tumor cells by blocking the
      enzymes necessary for tumor cell growth. Combining chemotherapy with topotecan may kill more
      tumor cells.

      PURPOSE: Phase I trial to study the effectiveness of combining UCN-01 with topotecan in
      treating patients who have recurrent ovarian epithelial cancer, fallopian tube cancer, or
      primary peritoneal cavity cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the maximum tolerated dose and recommended phase II dose of UCN-01 and
           topotecan in patients with recurrent ovarian epithelial, fallopian tube, or primary
           peritoneal cavity cancer.

        -  Determine the safety and tolerability of this regimen in these patients.

        -  Determine the relationship between clinical and pharmacokinetic effects of this regimen
           in these patients.

      OUTLINE: This is a dose-escalation, multicenter study.

      Patients receive UCN-01 IV over 3 hours on day 1 and topotecan IV over 30 minutes on days
      1-5. Treatment repeats every 21 days for at least 6 courses in the absence of disease
      progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of UCN-01 and topotecan until the maximum
      tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at
      least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 12 additional
      ovarian epithelial cancer patients are then treated at the recommended phase II dose.

      Patients are followed at 4 weeks and then every 3 months thereafter.

      PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 6-10
      months.
    

Intervention name(s): 7-hydroxystaurosporine; topotecan hydrochloride
Intervention type(s): Drug; Drug
Intervention MeSH terms: Topotecan; 7-hydroxystaurosporine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: primary peritoneal cavity cancer; recurrent ovarian epithelial cancer; fallopian tube cancer
Intravitreal Bevacizumab and Low Fluence Photodynamic Therapy
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to report the treatment effect and safety of combined
      intravitreal bevacizumab (IVB) and photodynamic therapy (PDT) with verteporfin using a
      reduced (RF) light fluence rate, in choroidal neovascularization (CNV) secondary to
      pathologic myopia.
    

Detailed description: 
      In this retrospective interventional case series, 16 patients with myopic CNV were included.
      All patients were treated with 1.25 mg of intravitreal bevacizumab followed by RF-PDT (25
      J/cm²), 2 days later. All patients were previously treated with IVB monotherapy and active
      leaking of CNV occurred 90 to 120 days after the treatment.

      Best-corrected visual acuity (BCVA-ETDRS), foveal thickness (FT) on optical coherence
      tomography (OCT), and fluorescein and indocyanine green angiographic (FA; ICG) findings were
      recorded. Follow-up evaluations were carried out for 12 months.
    

Intervention name(s): Combination therapy "IVB + rf-PDT"
Intervention type(s): Drug
Intervention description(s): low-fluence photodynamic therapy combined with intravitreal bevacizumab
Other intervention name(s): Combined therapy: IVB + rf-PDT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability and Pharmacokinetics of Single Rising Doses of YF476, a Gastrin Antagonist, in Healthy Men
Condition: Reflux Oesophagitis
MeSH terms: Esophagitis; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of the study were:

        -  To assess the safety, tolerability and pharmacokinetics of YF476 in healthy volunteers.

        -  To select a dose or doses of YF476 for detailed pharmacodynamic studies in healthy
           volunteers.
    

Detailed description: 
      YF476 is clearly a potent and selective gastrin/CCK-B antagonist and should inhibit basal and
      meal-stimulated gastric acid secretion and enhance gastric emptying of a liquid meal in man.
      Therefore YF476 might benefit patients with reflux oesophagitis. The compound has been
      remarkably well tolerated in animal toxicity studies at doses well in excess of the projected
      therapeutic dose in patients, and merits first administration to healthy volunteers. That
      study using the oral route of administration is described here. Extrapolation from data
      obtained with pentagastrin in animals suggest that single doses of less than 1mg of YF476
      should be active in man. However, extrapolation from data obtained in comparative studies
      with the H2-antagonists and with omeprazole in animals suggest that the therapeutic dose in
      patients with reflux oesophagitis will be larger, in the region of 10mg. A range of single
      doses will be used in this study. The maximum dose will be 10 times more than the expected
      therapeutic dose.
    

Intervention name(s): YF476
Intervention type(s): Drug
Intervention description(s): Two groups of six subjects received single rising oral doses of YF476 capsules or matching placebo. Each subject received 2 doses of YF476 and 1 dose of placebo. 4 subjects received active and 2 placebo at each dose level, as follows:
Group A YF476 0.5, 25 and 100mg by mouth Group B YF476 5.0, 50 and 100mg by mouth
Groups A & B were dosed alternately, at weekly intervals
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: YF476; gastrin receptor antagonist; gastric pH; healthy subjects
Safety, PK, and PD Study of IVRs Releasing TFV and LNG
Condition: Anti-Infective Agents; Anti-Retroviral Agents; Contraceptive Usage
Study type: Interventional
Phase: Phase 1

Summary: 
      This multi-center Phase I study is designed to characterize the safety, PK, and PD of TFV/LNG
      IVR to assess systemic and genital tract bioavailability in healthy women. The IVRs to be
      used in the study are TFV/LNG IVR (8-10mg per day/20μg per day) or placebo IVR. Samples will
      be obtained before, during and after 90 days of continuous or interrupted IVR use.
    

Detailed description: 
      The purpose of this multi-center Phase I protocol, titled Phase I, 90-Day Safety,
      Pharmacokinetic, and Pharmacodynamic Study of Intravaginal Rings Releasing Tenofovir and
      Levonorgestrel is to assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of
      the Tenofovir/Levonorgestrel Intravaginal Ring (TFV/LNG IVR).

      The study will enroll healthy, non-pregnant, ovulatory, HIV-uninfected women aged 18 to 50
      with a body mass index (BMI) less than 30 kg/m2, regular menstrual cycles (approximately
      26-35 days) by participant report, and willing to use non-spermicidal condoms for sex and
      follow other study restrictions. Women will be protected from pregnancy by abstinence from
      vaginal intercourse or agreeing to consistently use condoms.

      The enrollment goal is for approximately 60 participants to complete the study. A subset of
      approximately 20 women will be selected for an in-depth interview to take place during the
      first month of IVR use and again after 90 days of use.

      Women will be randomized to one of four arms: TFV/LNG IVR (8-10mg per day/20μg per day) for
      90 days (Continuous), TFV/LNG IVR (8-10mg per day/20μg per day) for 3x28 days (Interrupted),
      placebo IVR for 90 days (Continuous), or placebo IVR for 3x28 days (Interrupted) and will
      undergo blood, cervicovaginal and rectal fluid sample collections, and cervicovaginal tissue
      collections for PK and PD assessments before, during and after 90 days of continuous or
      interrupted IVR use.
    

Intervention name(s): TFV/LNG IVR; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Used for 90 days (Continuous or Interrupted); Used for 90 days (Continuous or Interrupted)
Other intervention name(s): Tenofovir/Levonorgestrel Intravaginal Ring
Intervention MeSH terms: Tenofovir; Levonorgestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV; LNG; TFV; IVR; Contraception; Prevention
Effects of a Structured Education Program on Blood Pressure in Essential Hypertensive Patients
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of a structured educational program for
      hypertensive patients. The program was developed at the University of Dusseldorf, Germany.
      The contents of the program are as follows: teaching of the background of hypertension,
      techniques of self estimation of blood pressure, life style and dietary habits, some
      information concerning the different pharmacological properties to treat hypertension
    

Detailed description: 
      see brief description section
    

Intervention name(s): structured educational program; participation in the educational program after 6 months
Intervention type(s): Behavioral; Behavioral
Intervention description(s): structured education and evaluation of hypertensive patients in a design similar to the DAFNE study design. Behavioural intervention follows the Dusseldorf-educational program; Control group consisting of patients randomly assigned to participate in the educational program 6 months later than the active group
Other intervention name(s): educational program at time of inclusion; delayed educational program six moth later
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: hypertension; self measurement of blood pressure; education program; life style
Virtual Reality Activity-based Training for Preventing Falls for Older Adults With Mild Cognitive Impairment
Condition: Mild Cognitive Impairment; Fall Prevention; Virtual Reality; Exercise Training
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      Using a Virtual Reality (VR) games-based application is as an innovative falls prevention
      technology in an aged care service. The VR intervention has promising effects on improving
      the physical and balance performances in the older adults.The study explored and evaluated
      the effects of VR activity-based training on falls prevention among community-dwelling older
      adults with mild cognitive impairment.
    

Detailed description: 
      A pilot randomized control trial study was applied to compare the effects on falls prevention
      between participants who experienced a full-immersive VR training and group-based exercise
      (Baduanjin) training. Eighteen participants were recruited from ausing convenience sampling
      and were randomly assigned into the VR group and the exercise group (non-VR). The
      participants in both wo groups' participants attended 16 falls prevention training sessions
      over eight weeks. Eligible participants identified with a higher risk of mild cognitive
      impairment and early dementia undertook three measurements, pretest (T1), post-test (T2) and
      follow up (T3). The primary outcomes assessed included changes in physical risks factor of
      falls, and the secondary outcomes assessed included changes in cognition and fall efficacy.
    

Intervention name(s): VR activity-based; Exercise-based (Baduanjin)
Intervention type(s): Other; Other
Intervention description(s): VR games activities were chosen for simulated cognitive-motor training in the VR group. The VR training modules for this study included fire drill, walking exercise, balancing game activities and community shopping practices. These training modules involved dual task components; the participant was expected to train up his/her physical and cognitive motor performances in an 8-week VR activity-based program. VR group participants received 2-sessions per week, 16 training sessions in total.; The exercise group used a traditional Chinese Qigong Baduanjin exercise incorporating with a fall prevention education strategy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Fall risk; VR; MCI; Ageing
Progress at Work - The Impact of Adalimumab on Work Related Productivity in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      The purpose of this study is to describe the impact of treatment with adalimumab on work
      related productivity and economic burden in patients with Rheumatoid Arthritis (RA) treated
      in Canada.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This is a Multi-Center Canadian Observational Study that will enroll rheumatoid arthristis
        (RA) subjects for whom the treating physician has decided to treat with adalimumab.
Sevoflurane, Propofol, Postoperative Pain
Condition: Healthy Adults; Gynecological Disease
MeSH terms: Genital Diseases, Female; Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The impact of anaesthetic method (intravenous vs. inhalational) has been proposed, but not
      proven in a large-scale study. The researchers aim to provide an investigation that has
      sufficient power to clarify the potential effect of anaesthetic method on postoperative need
      of opioids. Sevoflurane and propofol will be compared.
    


Intervention name(s): Sevoflurane; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): Sevoflurane inhalation anesthesia, sufficient amount to maintain adequate general anesthesia for surgery; Propofol intravenous anesthesia, sufficient amount to maintain adequate anesthesia during surgery
Other intervention name(s): Baxter Sevofluran; Propofol Lipuro
Intervention MeSH terms: Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Pain, Postoperative; Anesthetics, intravenous; Anesthetics, inhalation; Otherwise healthy adults undergoing general anesthesia for gynecological disease.
PAC-14028 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      1. Primary Objective:

             -  To evaluate safety and tolerability of single and multiple oral dosing of PAC-14028
                in healthy male volunteers.

        2. Secondary Objective:

             -  To evaluate pharmacokinetics and pharmacodynamics of single and multiple oral
                dosing of PAC-14028 in healthy male volunteers.
    


Intervention name(s): PAC-14028
Intervention type(s): Drug
Intervention description(s): tablets, oral administration, single/multiple dosing, dose escalation
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)