bioihbjkbjnl/mcl2 huggingface dataset:
Number of Multiple Breath Washout Tests in Adults With Pulmonary Disease and Healthy Controls
Condition: Healthy Controls; Chronic Obstructive Pulmonary Disease; Bronchial Asthma; Sarcoidosis
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Asthma; Sarcoidosis
Study type: Observational

Summary: 
      The investigators aim to determine the optimal number of measurements required for
      multiple-breath-washout derived lung function parameters in adults with pulmonary disease as
      well as in healthy controls
    


Intervention name(s): multiple breath washout
Intervention type(s): Diagnostic Test
Intervention description(s): determination of lung clearance index using SF6 multiple breath washout
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        inpatients, outpatients, students, employees
Vasculaire Compression System Increases Flow Velocity in the Femoral Vein
Condition: Venous Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis
Study type: Interventional

Summary: 
      The objective of this clinical study was to demonstrate the performance of the Vasculaire
      Compression System to increase femoral venous peak velocity (PFV) in healthy subjects. This
      study was a single-arm, open label, prospective, single-center clinical study.
    

Detailed description: 
      Venous thromboembolism, e.g. deep vein thrombosis (DVT) and pulmonary embolism, occurs in
      approximately one in 1,000 persons in the United States annually and results in more than
      250,000 hospital admissions annually in the United States. Intermittent pneumatic compression
      (IPC), which prevents stasis in the lower limbs, has been shown to be a safe and effective
      method of prophylaxis of DVT in studies comparing the incidence of DVT and pulmonary embolism
      with and without IPC. IPC devices decrease venous stasis by augmenting the venous blood flow
      in the lower extremities. Studies have suggested that an important indicator of the
      effectiveness of an IPC device in preventing DVT is the peak femoral venous velocity
      augmentation during the compression phase as compared with the decompression phase of the
      device.

      IPC devices produced in the early 1980s and 1990s were cumbersome, noisy and required
      external power sources, making them suitable only for non-ambulatory patients. Furthermore,
      these devices have been associated with poor compliance in trauma patients in a hospital
      setting, and the poor compliance was associated with a higher rate of DVT.

      The aim of this study is to test the hemodynamic performance of a new portable IPC device,
      the Venous Health Systems' Vasculaire Compression System. This new device is designed to
      provide patient comfort and convenience of use while providing similar improvement in venous
      blood flow when compared with existing IPC devices.
    

Intervention name(s): Pneumatic Compression therapy
Intervention type(s): Device
Intervention description(s): Subject comparison analysis of femoral venous Peak Flow Velocity at rest and during compression therapy.
Other intervention name(s): Intermittent pneumatic compression; Sequential compression
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Deep Vein Thrombosis; Effects of compression therapy; Peak Flow Velocity
Pharmacokinetic/Pharmacodynamic Study of MP-513 With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effect of MP-513 on 24-h glycemic control in
      patients with type 2 Diabetes for 4 weeks administration.
    


Intervention name(s): MP-513; MP-513; Placebo of MP-513
Intervention type(s): Drug; Drug; Drug
Intervention description(s): MP-513 10 mg, once a day, for 4 weeks; MP-513 20 mg, once a day, for 4 weeks; MP-513 placebo, once a day, for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: insulin resistance
Comparative Study of the Efficacy of Oral Versus Intravenous Hydration as a Preventive Measure of Contrast-induced Nephropathy (CIN) in Patients With Renal Insufficiency (RI) Grade III Under Study Conducting Computed Tomography (CT)
Condition: Renal Insufficiency
MeSH terms: Kidney Diseases; Renal Insufficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates if oral hydratation is as effective as endovenous hydratation in the
      prophylaxis of contrast-induced nephropathy in patients renal insufficiency grade III under
      study conducting contrasted computed tomography.
    


Intervention name(s): Oral hydratation; Bicarbonate endovenous hydratation; Saline endovenous hydratation
Intervention type(s): Other; Drug; Drug
Intervention description(s): 500 mL of water two hours before computed tomography and 2000 milliliters 24 hours after performing computed tomography; Intravenous hydration: sodium (1.6 molar) Bicarbonate 3 mL / kg / h starting one hour before the computed tomography and sodium bicarbonate (1/6 M) 1 mL / kg / h during the hour after computed tomography.; If there is contraindication for administration of bicarbonate the pattern of intravenous hydration is performed with saline solution: 3 ml / kg / h for 1 hour before the procedure and normal saline 1 mL / kg / hour for hour after computed tomography.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: contrast-induced nephropathy; renal insufficiency; computed tomography
Plasma Volume Replacement (PVR) Therapy With Colloid and Crystalloid Solutions
Condition: Plasma Volume Replacement; Surgery of the Pancreatic Head
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the efficacy of target controlled fluid therapy
      with a hyper-oncotic balanced HES solution compared to an iso-oncotic HES solution in
      patients undergoing elective surgery of the pancreatic head. A third group receiving a
      balanced electrolyte solution (without colloidal volume replacement) will serve as a control
      for descriptive analysis.
    


Intervention name(s): HES 10%; HES 6%; balanced electrolyte solution
Intervention type(s): Drug; Drug; Drug
Intervention description(s): HES 10% dissolved in plasma adapted Ringer's solution (balanced solution).; HES 6% dissolved in plasma adapted Ringer's solution (balanced solution); plasma adapted Ringer's solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PVR; HES 130; pancreatic head; goal-directed; intraoperative PVR in elective surgery of the pancreatic head
Study to Investigate Safety, Tolerability and PK Following Single and Multiple Ascending Doses of AZD7295 in Japanese
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to investigate the safety and tolerability of single
      and multiple oral doses of AZD7295 in healthy male Japanese subjects. This will be done by
      comparing the effect of AZD7295 to placebo. The study will aslo investigate the absorption,
      distribution and disappearance of AZD7295 in the body.
    


Intervention name(s): AZD7295; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ascending single doses (start dose 90 mg), oral solution and then multiple ascending dose (tbd based on single dose results), oral solution; multiple ascending dose (tbd based on single dose results), oral solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Phase I; Japan; Japanese; oral solution
A Study of LY3437943 in Healthy Participants and Participants With Impaired Renal Function
Condition: Healthy; Renal Insufficiency
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to assess the amount of study drug that reaches the
      bloodstream and the time it takes for the body to get rid of it when given to participants
      with renal (kidney) impairment compared to healthy participants. The study will last up to 5
      weeks, excluding screening.
    


Intervention name(s): LY3437943
Intervention type(s): Drug
Intervention description(s): Administered SC.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Nuvigil on Fatigue
Condition: Menopause
MeSH terms: Fatigue
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if armodafinil improves quality of life and is an
      effective treatment of fatigue in symptomatic perimenopausal and postmenopausal women.
    

Detailed description: 
      Fatigue is one of the most prevalent symptoms occurring in peri- and postmenopausal women. It
      is strongly associated with reduced quality of life in this population. Studies have shown a
      strong association between fatigue and menopausal symptoms such as hot flashes, vaginal
      symptoms, and sexual dysfunction. Because sleep disturbance commonly co-occurs in women with
      hot flashes as a result of nocturnal hot flashes disrupting sleep, sleep disturbance may
      explain the association between hot flashes and fatigue in this population. However evidence
      suggests that fatigue can occur in the absence of sleep disruption, indicating that sleep
      problems do not exclusively explain the etiology of fatigue in this population.

      Armodafinil is a wakefulness-promoting agent that acts as a central nervous system stimulant.
      It is chemically and pharmacologically unrelated to other CNS stimulants, such as
      methylphenidate and amphetamine. Armodafinil is FDA approved to increase wakefulness in
      patients with excessive sleepiness due to narcolepsy, obstructive sleep apnea, and shift work
      sleep disorder. It has not be studied in menopause-associated fatigue.

      In the proposed study, the investigators plan to investigate the effect of armodafinil on
      quality of life and fatigue in a population of peri- and postmenopausal women with fatigue
      and reduced quality of life who do not have primary sleep disorders, significant levels of
      insomnia, or depression.
    

Intervention name(s): Armodafinil
Intervention type(s): Drug
Intervention description(s): Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio. No primary outcomes were studied in the discontinuation phase.
Other intervention name(s): Nuvigil
Intervention MeSH terms: Modafinil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fatigue; menopausal symptoms; hot flashes; Vasomotor symptoms; perimenopause; related Quality of life
Effects of Short-intensity Modified Constraint-induced Movement Therapy on Hand Function in Stroke Patients.
Condition: Hemorrhagic Stroke; Ischemic Stroke; Rehabilitation
MeSH terms: Stroke; Ischemic Stroke; Hemorrhagic Stroke
Study type: Interventional

Summary: 
      To determine effects of short-intensity modified constraint-induced movement therapy on hand
      function in stroke patients.
    

Detailed description: 
      The aim of the study is to determine the effects of a short-intensity modified CIMT (mCIMT)
      program on hand function in stroke patients. This study will be a randomized controlled trial
      comprising two groups, an experimental group in which patients will be given short-intensity
      mCIMT along with conventional therapy. A control group, in which participants will be given
      conventional therapy alone. Patients will be assessed with the Wolf Motor Function Test, the
      Motor Activity Log, and the Ashworth Scale before and after treatment. The data will be
      analyzed by using SPSS for windows software version 25. Statistical significance will be set
      at p=0.05.
    

Intervention name(s): short-intensity modified CIMT and conventional therapy; conventional therapy alone
Intervention type(s): Other; Other
Intervention description(s): an experimental group receiving short-intensity modified CIMT and conventional therapy; a control group receiving conventional therapy alone.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be allocated into two groups by randomization. The experimental group in which patients will be given short-intensity mCIMT along with conventional therapy. A control group, in which patients will be given conventional therapy alone. The therapy regime will be 3 hours/ day, 5 days/week, and 4 successive weeks.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hemorrhagic Stroke; Ischemic Stroke; Rehabilitation
Trial Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery for Women Cystocele Repair.
Condition: Cystocele
MeSH terms: Cystocele; Hernia
Study type: Interventional

Summary: 
      The primary objective of this study is to compare with PFDI-20 questionnaire the functional
      outcome of laparoscopic sacrocolpopexy and vaginal mesh surgery in the treatment of
      symptomatic exteriorised cystocele up to 4 years after surgery.

      The secondary objectives of this study are the following:

        1. to compare the two techniques for anatomical results based on the clinical evaluation of
           patients with POP-Q.

        2. to overall quality of life assessment and expectations of patients.

        3. to compare the two techniques for the long-term safety. The evaluation will focus on the
           adverse effects of long-term sexual and genital symptoms, urinary and digestive
           functional symptoms, and chronic pelvic pain.

        4. to compare the improvement of the functional outcome assessed by PFDI-20 questionnaire
           (matched-analysis before versus after).
    


Intervention name(s): laparoscopic sacrocolpopexy; vaginal mesh surgery
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
German Observational Multicenter Study of Patients With Fabry Disease Under Chaperone Therapy With Migalastat-HCl.
Condition: Fabry Disease
MeSH terms: Fabry Disease
Study type: Observational

Summary: 
      The objective of the study is to document long term data on treatment with Migalastat under
      "real world" conditions. The selection of patients is based on the SmPC/Fachinformation. The
      study duration/patient will be 2 years.
    

Detailed description: 
      Phase 3 data should be confirmed in this study with long-term data.

        -  LVMI is expected to remain stable or to be ameliorated over an average of 24 months
           treatment duration. The LVMI reduction observed in patients followed up to 24 months is
           expected to be significantly reduced with a mean change of -6.6 g/m2 (-11.0, -2.1, 95%
           CI).

        -  eGFR [CKD-EPI] is expected to remain stable over an average of 24 months treatment
           duration. The long-term effect of Migalastat on eGFR is expected to be comparable to the
           decline over time in healthy adults. The annualized rate of change over this period is
           expected to be ≤1 mL/min/1.73 m2 in females and ≤3 mL/min/1.73 m2 in males.

        -  Significant reduction is expected in plasma lyso-Gb3 concentration at month 6, month 12
           and month 24 following treatment with Migalastat.

        -  ERT-naïve patients treated with Migalastat are expected to show an improvement of GI
           symptoms (diarrhea) over 24 months.

        -  No progression of White Matter Lesions (WML) during treatment duration is expected.

        -  No higher frequency of stroke/transient cerebral ischemia during treatment duration is
           expected.

        -  Severity of neuropathic pain is expected to remain stable or to improve during treatment
           duration.

        -  Dosing/amount of symptomatic medications of neuropathic symptoms is expected to decrease
           during treatment duration.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        At therapy initiation adult male and female patients with FD will be identified, whose GLA
        mutations are amenable for a stimulation with Migalastat-HCl, and will be treated with
        Migalastat-HCl at the recommended dose continuously for 24 months according to the
        manufacturers' instructions (SmPC).
Comparing the Effect of the Water Drinking Test on Intraocular Pressure
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Observational

Summary: 
      A test that was common in the 1960's and was used to detect primary open angle glaucoma was
      the water drinking test (patients drank 1 quart of water to stress the fluid drainage
      mechanism of the eyes. Intraocular pressure was then measured over the next hour). Recently
      this test has been demonstrated as a predictor of peak eye pressure during the day. The
      purpose of this study is to compare the results of the water drinking test between eyes that
      have undergone trabeculectomy and eyes that have undergone tube shunt surgery.
    


Intervention name(s): Water Drinking Test
Intervention type(s): Procedure
Intervention description(s): The Water Drinking test has been identified as a reliable and safe tool to predict maximum intraocular pressure values during a diurnal tension curve and to assess the efficacy of surgical interventions. Participants are asked to drink 10 ml/kg water (or approximately 0.33 ounces of water for every 2.2 pounds of weight or about 2.5 cups for a 150 lb. individual) over 15 minutes. Intraocular pressure is assessed every 15 minutes for one hour.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All participants will have open angle glaucoma and have undergone either tube shunt surgery
        or trabeculectomy. All participants will be matched for range of recent intraocular
        pressure (average over the prior three visits of <12 mm Hg, 12 to <18 mm Hg, or >18 mm Hg),
        as well as number of medications (none, 1-2, 3 or more).
      
Keywords: Water drinking test; trabeculectomy; tube shunt
Availability of Poor Quality Embryos
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      The purpose of this study is to explore a method to identify the viability of day-3 poor
      quality embryos
    

Detailed description: 
      Day-3 poor quality embryos are related to significant lower clinical pregnancy,so freezing
      numerous poor quality embryos are clinical impractical. To ensure the successful pregnancy
      and to enhance the availability of the poor quality embryos, day-3 poor quality embryos are
      further cultured to different developmental stage and then cryopreserved. The viability of
      these embryos are tested in frozen-thawed transfer.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        unfertile women
      
Keywords: day-3 poor quality embryo; vitrification; clinical outcome
NMDA Receptor Modulation for Hyperarousal in PTSD
Condition: Depression; Post Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1b study examines the safety and efficacy of parenterally-administered lanicemine
      in a parallel-arm, randomized, double-blind, placebo-controlled trial in adult patients
      (N=24) with significant PTSD symptoms and elevated anxiety potentiated startle (APS).
      Investigator hypothesize that lanicemine (100 mg) displays a normalization of APS following
      three infusions over 5 non-consecutive days. If target engagement is demonstrated and the
      drug is safe and tolerable in this patient population, investigator will proceed to a larger
      POC study.
    

Detailed description: 
      This study aims to provide a rigorous test of functional target engagement and "go/no go"
      milestones for a subsequent POC trial. Investigator will conduct a parallel-arm, randomized,
      double-blind, placebo-controlled study to assess lanicemine (100 mg) with respect to a
      functional pharmacodynamic readout of target engagement (APS). Twenty-four patients with
      significant PTSD symptoms and elevated APS will be randomized to one of 2 treatment groups
      [placebo or 100 mg], and undergo three 60 min parenteral infusions over a 5 day period. APS
      and other neurophysiological biomarkers will be tested before and after the 1st and 3rd
      treatment.

      Primary Objective is to examine, relative to placebo, whether lanicemine will demonstrate
      normalization of the APS response following three treatments.

      Secondary Objectives are to examine, relative to placebo, whether lanicemine will demonstrate
      effects on P50 auditory evoked potentials, gamma band EEG, and Mismatch Negativity.
      Investigator also explore whether target engagement will mediate the effect of treatment on
      CAPS-5 scores.
    

Intervention name(s): Lanicemine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Three 60 min parenteral infusions over a 5 day period; Three 60 min parenteral infusions over a 5 day period
Other intervention name(s): BHV-5500; Baxter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Self Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis
Condition: Knee Osteoarthritis; Chronic Pain
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Chronic Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine the feasibility and preliminary efficacy of two
      weeks of self Transcranial Direct Current Stimulation (tDCS) for pain in older patients with
      knee osteoarthritis (OA).
    


Intervention name(s): Soterix 1x1 tDCS mini-CT Stimulator device
Intervention type(s): Device
Intervention description(s): Transcranial Direct Current Stimulation (tDCS) involves the application of weak direct electric current to the head in a noninvasive and painless manner. tDCS with a constant current intensity of 2 mA will be applied for 20 minutes per session daily for 2 weeks (Monday to Friday) via the Soterix 1x1 tDCS mini-CT Stimulator device. Participants will self-administer tDCS at their home or a private room for two weeks (Mondays-Fridays) under real-time supervision by the research staff.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Knee Osteoarthritis; Chronic Pain; Osteoarthritis; Transcranial Direct Current Stimulation; tDCS