bioihbjkbjnl/mcl2 huggingface dataset:
Elite Sport and Development of Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      International studies have shown that elite athletes have a high prevalence of respiratory
      symptoms and asthma as compared to normal subjects. It is unclear whether the increased
      prevalence of asthma in elite athletes reflects "traditional asthma" or whether it is a
      special form of "sports asthma". The treatment of elite athletes with asthma seems to vary
      widely, and only a few studies have focused on the treatment of elite athletes with asthma.
      Further knowledge of the pathogenesis of sports asthma would lead to a greater understanding
      and better treatment of the condition. This study will investigate the type of airway
      inflammation in elite athletes and examine the effect of treatment with inhaled steroids in
      combination with long-acting beta-agonists versus placebo in the same group.
    


Intervention name(s): Seretide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Combination of inhaled corticosteroids (250 microgr) and inhaled long-acting beta2-agonists (25 microgr); Inhaled sugar powder in a placebo inhaler
Intervention MeSH terms: Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Sport; Asthma; Treatment; Airway inflammation
Do High Doses of Protein Supplements Affect Serum Lipid Profiles?
Condition: To Study the Effects of Protein Supplements on Blood Tests
Study type: Observational

Summary: 
      Protein supplements are widely used among people going to the gym. The effects of these
      substances on blood biochemical, hematological, inflammatuary, glucose metabolism markers and
      lipid profile is not well known. The previous studies on this issue give inconclusive
      results. So the investigators aimed to investigate this subject and compare the blood tests
      between subjects using and not using protein supplements.
    

Detailed description: 
      As more people are doing regular exercises, people using protein supplements are also
      increasing. The effects of these substances on blood lipid profiles, biochemical,
      hematological parameters, inflammatory and glucose metabolism markers are not well known. So
      the investigators of this study planned to search the effects of these substances on blood
      tests. Totally 69 subjects going to the gym for at least three preceding months were included
      to the study. They were divided into two groups: the ones using protein supplements and the
      ones who never used these substances. Demographic and clinical characteristics were recorded.
      Dietician assessed the dietary habits of the subjects. Blood was drawn for the tests
      mentioned above from all of the subjects. And the results were compared between the two
      groups.
    

Intervention name(s): protein supplement
Intervention type(s): Dietary Supplement
Intervention description(s): Protein supplement usage for at least three preceding months in varied amounts
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy population going to the gym for at least three preceding months
      
Keywords: Protein supplement; Serum creatinine; Serum sodium; Glucose metabolism; Lipid profile; C-reactive protein
Mobility Exercises for Gait (MEG Neuroplasticity Project)
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      This study is directed at identifying a the neurophysiological changes seen in children with
      cerebral palsy (CP) after undergoing physical therapy. The specific aims of the study will:
      (1) determine the changes in the sensorimotor cortical activity after physical therapy, (2)
      determine the mobility, participation and muscular performance improvements after therapy,
      and (3) determine the changes in a child's participation in activities outside of the
      laboratory environment.
    

Detailed description: 
      This study is directed at identifying a the neurophysiological changes seen in children with
      cerebral palsy (CP) after undergoing physical therapy. The specific aims of the study will:
      (1) determine the changes in the sensorimotor cortical activity after physical therapy, (2)
      determine the mobility, participation and muscular performance improvements after therapy,
      and (3) determine the changes in a child's participation in activities outside of the
      laboratory environment. The study consists of a cohort of children with CP that will undergo
      an action-perception training protocol, a cohort that will undergo a high velocity power
      training protocol and a cohort that will undergo body weight supported treadmill training.
      Participants will be between the ages of 9-18 years and have gross motor function
      classification score levels between I-III. All participants will complete final initial
      baseline measures of their brain activity, mobility, muscle performance, and participation
      activity outside of the laboratory. After completing these tests, the children will undergo
      the respective physical therapy protocols for 8-weeks (3 days a week). After the 8-weeks of
      therapy, both groups will repeat the same tests that were completed at baseline. Follow-up
      assessment will consist of a physical therapist scheduling a time to visit the family at
      their house and ask them questions about the child's participation in activities.
    

Intervention name(s): Physical Therapy
Intervention type(s): Other
Intervention description(s): Physical therapy will be implemented three times a week with subjects over an eight week span. Each physical therapy session will last 40-minutes and will be conducted by a licensed physical therapist.
Other intervention name(s): Therapeutic Gait Training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gait Training; Power Training; Action-Perception Training; Brain Imaging; Mobility
Study Assessing the Efficacy and Safety of STN1013600 Ophthalmic Solution 0.1% and 0.3% Compared With Placebo in Subjects With Presbyopia
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase IIa study to assess efficacy and safety of STN1013600 ophthalmic solution
      (0.1%, and 0.3 %), twice daily when compared to Placebo in subjects diagnosed with
      presbyopia. This study will consist of a Screening Period of up to 15 days followed by a 2
      Month Treatment Period. After the Treatment Period subjects will be followed for a one-month
      treatment free period.
    


Intervention name(s): 0.1% STN1013600 ophthalmic solution; 0.3% STN1013600 ophthalmic solution; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.1% STN1013600 ophthalmic solution 1 drop BID for 2 months; 0.3% STN1013600 ophthalmic solution 1 drop BID for 2 months; Placebo ophthalmic solution 1 drop BID for 2 months
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Santen, Presbyopia, Eye
ProAlgaZyme Novel Algae Infusion: Applications in Metabolic Syndrome
Condition: Metabolic Syndrome X
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effects of supplementation with ProAlgaZyme (a
      novel fermentation product of a freshwater algae ecosystem) vs. placebo on Metabolic Syndrome
      and indicators of cardiovascular health including: body weight and fat, blood lipids,
      inflammatory markers such as hsCRP, blood pressure and fasting blood glucose.
    

Detailed description: 
      Metabolic syndrome, a set of symptoms strongly associated with increased risk for both
      cardiovascular disease and diabetes, is generally linked to obesity and has become a serious
      problem in many industrialized countries. Agents that aid in weight loss or help to normalize
      blood lipids or inflammation may reduce the risk of metabolic syndrome and therefore, reduce
      the risk of cardiovascular disease and diabetes. This study is a single-center, double-blind,
      placebo-controlled, parallel design, to evaluate the effects of ProAlgaZyme (4 fl. oz. daily)
      on metabolic syndrome and markers of cardiovascular health including blood lipids,
      inflammatory markers and anthropometric measurements.

      Comparisons: ProAlgaZyme vs. placebo [Time frame: 10 weeks]
    

Intervention name(s): ProAlgaZyme
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: ProAlgaZyme; Metabolic syndrome; Inflammation; Cardiovascular; hsCRP; Lipids; Algae
Effect of the Aquaretic Tolvaptan on Nitric Oxide System (TORA)
Condition: Cardiovascular Diseases; Nephropathy
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the effect of tolvaptan on renal water, sodium
      and potassium excretion, plasma concentration of vasoactive hormones,central blood pressure,
      pulse wave velocity (PWV) and augmentation index, basal and during inhibition of nitric oxide
      synthesis in healthy subjects.
    

Detailed description: 
      Tolvaptan is a vasopressin antagonist (V2-antagonist) and is used in treatment of
      hyponatremia. Animal studies have demonstrated that inhibition of V2 receptors in the renal
      principal cell increases renal free water clearance and renal sodium excretion.

      Treatment with V2-receptor antagonists increases vasopressin concentration in plasma that
      stimulates V1-receptors in the vascular bed. This may change both central and peripheral
      hemodynamics and plasma concentration of vasoactive hormones. Changes in hemodynamics and
      hormone concentration may consequently change renal sodium and water handling.

      The nitric oxide system plays a central role in both renal sodium and water handling and
      regulation of vascular tone and blood pressure.

      The effects of tolvaptan the circulation and kidneys is investigated by using measurements of
      biomarkers specific for the sodium/water balance in the urine and by measurements of
      vasoactive hormones in the blood after administration of tolvaptan and L-NMMA infusion.
    

Intervention name(s): Tolvaptan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 15 mg pr day for 1 day; 1 tablet Unikalk 1 pr day for 1 day
Other intervention name(s): Samsca; Unikalk
Intervention MeSH terms: Tolvaptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Tolvaptan; L-NMMA; Healthy subjects; Nephrology; Cardiology
Study of PK/PD, Safety and Tolerability of LIK066 in Patients With Decreased Renal Function.
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial was to evaluate whether the study drug, LIK066, causes glucose
      excretion in urine in patients with varying degrees of decreased kidney function and in
      subjects with normal kidney function. Blood samples were collected to measure the
      concentrations of LIK066 and to study the pharmacokinetics of LIK066. Pharmacokinetics is
      meant to study how LIK066 is absorbed, distributed and eliminated, in other words what the
      body does to the drug. The results of this study may be used to help determine whether LIK066
      can be used to treat people with reduced kidney function and the proper dosing regimen.
    


Intervention name(s): LIK066
Intervention type(s): Drug
Intervention description(s): LIK066 50 mg tablets taken orally once daily before breakfast for 7 days.
Intervention MeSH terms: Licogliflozin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: renal function; sodium-glucose co-transporter; pharmacokinetics; decreased renal function; decreased kidney function; kidney disease; urinary glucose excretion; UGE
A Food Effect Study of CT-L01 After Oral Administration in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, randomized, open-label, single-dose, crossover, single-center study to
      evaluate food effect on the pharmacokinetics and safety of CT-L01 after oral administration
      in healthy volunteers.
    


Intervention name(s): CT-L01 12.5/1,000 mg; CT-L01 12.5/1,000 mg
Intervention type(s): Drug; Drug
Intervention description(s): FDC tablet, 2 tablets at a time, oral administration, dosing under fasting condition; FDC tablet, 2 tablets at a time, oral administration, dosing after high-fat meal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Multicenter Randomized Active-controlled Study to Investigate Efficacy & Safety of IV FCM in Pediatric Patients With IDA
Condition: Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to demonstrate the efficacy and safety of intravenous
      ferric carboxymaltose (FCM), compared to oral iron, in pediatric participants who have iron
      deficiency anemia.
    

Detailed description: 
      This is a Phase III, multicenter, randomized, active-controlled study that compares the
      efficacy and safety of FCM to oral iron in pediatric participants with IDA and a documented
      history of an inadequate response to oral iron therapy at least 8 weeks (56 days) prior to
      randomization.

      Participants who satisfy the inclusion requirements and no exclusion criteria will be
      eligible to participate in this study and enter into a screening phase to confirm
      eligibility. Randomization will occur via the Interactive Response Technology (IRT) system in
      a 1:1 ratio to either Group A, participants receiving FCM, or Group B, participants receiving
      oral iron (oral solution drops, elixir or oral tablets). Randomization will be stratified by
      baseline Hgb (<10, ≥10 g/dL) and age (1 to <12 years and ≥12 to 17 years).

      The oral ferrous sulfate formulation received will be based on the participant's age, such
      that infants and children (1 to <4 years of age) will receive ferrous sulfate drops, children
      (≥4 to <12 years of age) will receive ferrous sulfate elixir, and adolescents (≥12 to 17
      years of age) will receive ferrous sulfate tablets. Participants who experience adverse
      clinical symptoms due to the oral iron during the treatment phase may have a weight-based
      dose of ferrous sulfate reduced from 6 mg/kg to 3 mg/kg. If the participant is receiving
      tablets, the dose will be reduced from one tablet taken twice daily to one tablet per day.

      Once randomized, all participants will return for efficacy and safety evaluations, including
      adverse events and laboratory assessments, on Days 7, 14, 28, and 35. Additional
      pharmacokinetic sampling and analyses will be performed for participants receiving FCM on
      Days 0 and 7.
    

Intervention name(s): Ferric carboxymaltose; Ferrous Sulfate
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous iron; oral iron therapy
Other intervention name(s): Injectafer; Ferinject; oral iron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluating the Effect of a Decision Aid on Shared Decision Making for Prostate Cancer Screening
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      Decision-aids are tools to educate patients on a given topic so that they may better
      participate in shared-decision making in their health care. Given the complexities associated
      with PSA testing, many professional organizations have advocated for shared-decision making
      for PSA testing. However, no consensus exists as to how best educate and involve patients in
      the shared-decision making process. The goal of this study is to evaluate a pilot program
      utilizing a simple PSA screening decision-aid presented in two different fashions in a
      primary care clinic with a large fraction of African-American patients. The investigators
      will evaluate the effectiveness of this program to educate patients on the risks and benefits
      of prostate specific antigen (PSA) testing, on their subsequent level of comfort with their
      decision about whether to receive PSA testing, and on the comfort level of physicians on
      their patient's decisions regarding PSA testing, and importantly, how well these strategies
      can be implemented into the daily work-flow of a clinic. If successful, this program may
      serve as a model for the broader implementation of such strategies across Minnesota and the
      country.
    

Detailed description: 
      This pilot project will evaluate two approaches to implementing the use of a simple printed
      PSA screening decision-aid (DA) administered in an urban primary care clinic populated with a
      significant number of African-Americans. All subjects will complete a survey assessing their
      knowledge and attitudes about PSA screening and shared decision making (SDM), and physicians
      will also be briefly queried about their perceptions of the SDM process.

      After the first three month implementation period we will conduct focus groups with clinic
      staff to guide changes and refinements to the use of DA in the clinical setting. Another
      three month implementation period will follow using the same methods to assess outcomes.
      Finally we will conduct another round of focus groups to assess the overall impact of the
      interventions.
    

Intervention name(s): PROCASE Decision-Aid
Intervention type(s): Other
Intervention description(s): VA health services researchers have developed a patient education pamphlet for prostate cancer screening. The pamphlet, titled "The PSA test for prostate cancer: Is it Right for ME was created by members of the PROstate CAncer Screening Education (PROCASE) study team. A modified version of the PROCASE decision aid will be utilized in this study.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: PSA screening; Decision aids
A Study to Assess the Pharmacokinetics of PXL770 After 4 Weeks of Treatment in Subjects With NAFLD
Condition: Nonalcoholic Fatty Liver
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the pharmacokinetics of PXL770 after 4 weeks of treatment.
    

Detailed description: 
      The study will be performed in subjects with Nonalcoholic Fatty Liver Disease. The primary
      endpoint will be the assessment of PXL770 exposure in plasma.
    

Intervention name(s): PXL770; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral capsule; Oral capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Drug-drug Interaction Study of Evobrutinib With Midazolam in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will investigate the effect of single dose and multiple doses of M2951 on midazolam
      Pharmacokinetics (PK) in healthy participants.
    


Intervention name(s): Midazolam; M2951
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive single oral dose of midazolam on Days 1, 3 and 13 under fed conditions.; Participants will receive multiple oral doses (twice daily) of M2951 on Day 3 to Day 13 under fed conditions.
Other intervention name(s): MSC2364447C; Evobrutinib
Intervention MeSH terms: Midazolam
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Midazolam; Cytochrome P450; Autoimmune disorders; Inflammatory disorders; Sedative-hypnotic
Mobilized Psychoeducation and Skills Based Intervention (Pep-Pal) for Caregivers of Patients With Advanced Illness
Condition: Distress; Anxiety; Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      The proposed project is a pilot study of the Pep-Pal (Psychoeducation and Skills Based
      Intervention) versus a treatment as usual control group. A total of 60 caregivers; including
      caregivers of patients with HSCT (Hematopoietic Stem Cell Transplantation), caregivers
      enrolled in Phase I clinical trials, and caregivers of patients with advanced cancer (Stage
      III, solid tumor) will be enrolled in this study. The investigators do not expect different
      outcomes from these three groups, rather these populations are selected to optimize
      recruitment within a short time frame. The caregivers will be randomized to either treatment
      as usual or Pep-Pal intervention.
    

Detailed description: 
      The proposed project is a pilot study of the Pep-Pal intervention versus a treatment as usual
      control group. A total of 60 caregivers; caregivers of patients with HSCT, caregivers of
      patients enrolled in phase I oncology trials, and caregivers of patients with advanced cancer
      (Stage IV, solid tumor) will be enrolled in this study. The investigators do not expect
      different outcomes from these three groups, rather these populations are selected to optimize
      recruitment within a short time frame. The caregivers will be randomized to either treatment
      as usual or Pep-Pal intervention. The proposed study population is based on prior research
      indicating that caregivers of patients receiving HSCT, caregivers of patients enrolled in
      phase I oncology trials, and caregivers of patients with advanced cancer experience
      significant distress. In addition, an initial study of caregivers of patients receiving
      allogeneic-HSCT were able to benefit from a brief, cognitive behavioral stress management
      treatment approach. A study examining distress in phase I oncology clinical trial patient
      caregivers highlighted the need for more support for this significantly distressed
      population. Furthermore, initial results of the qualitative development study for Pep-Pal
      yielded support for a mobilized platform delivery of resources for caregivers to manage
      distress because they acknowledged many barriers to engaging in in-person treatment to manage
      distress.
    

Intervention name(s): Pep-Pal; Treatment as Usual
Intervention type(s): Behavioral; Other
Intervention description(s): Pep-Pal is designed to complement the utilization of other resources, provide support when no other resources can be obtained, or provide support in the interim until greater resources can be obtained. In this way, Pep-Pal is a resource for our most hard to reach caregivers.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Supportive Care
Keywords: Cancer; Caregivers; Pep-pal; Pep-Pal + Treatment as Usual; Treatment as Usual