bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Oral Adenosine-triphosphate (ATP) on Human Muscle Performance
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Adenosine-triphosphate (ATP) serves as the sole energy source for muscle contraction.
      Therefore human performance of brief maximal exercise is limited, in part, by the
      availability of ATP to the contracting muscle. Because muscle ATP storage is small (enough to
      sustain maximal exercise for less than 1 second), factors that enhance either storage or
      resynthesis of ATP may have a positive impact on repeated muscle contractions. The current
      study will test the hypothesis that increasing ATP availability to muscle via oral
      supplementation will improve performance of repeated high intensity exercise as measured by
      a) work performed in each of the three 50 contraction fatigue tests, b) sum of total work
      performed, and c) percentage decrement in total work from the first to third third 50
      contraction test.
    

Detailed description: 
      To date we have studied 10 subjects who have followed through with all 3 of the original
      interventions (Placebo, 250 mg PeakATP/d and 400 mg PeakATP/d). Currently we have received
      approval and are expanding the study with 5 additional subjects who will receive the Placebo,
      400 mg PeakATP/d and the 400 mg PealATP/d plus proprietary blend interventions.
    

Intervention name(s): PeakATP 250; Placebo; PeakATP 400; PeakATP 400 plus proprietary blend
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): The nutritional intervention provides for oral ingestion of 250 mg PeakATP per day; Placebo capsules that are comparable in size and color to the active comparator for blinding purposes; The nutritional intervention provides for oral ingestion of 400 mg PeakATP per day; The nutritional intervention provides for oral ingestion of 400 mg PeakATP per day plus a proprietary blend of additional nutrients
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Supplemental ATP; Muscle Work Performed; Muscle Fatigue
The Effect of Metformin on Composition of Human Gut Bacteria
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      OBJECTIVE: Investigate structural changes in the human gut microbiota and associated changes
      in metabolic markers in urine, saliva, blood and fecal samples following metformin treatment.

      DESIGN: An, 18 week, one-armed cross over intervention trial consisting of a 6-week
      pre-intervention period, 6-week intervention period and a 6-week post-intervention period. 25
      healthy young men will be included in the trial.

      INTERVENTION: Six-week Metformin treatment to young healthy men.
    

Detailed description: 
      An, 18 weeks, one-armed cross over intervention trial consisting of a 6-weeks
      pre-intervention period, 6-weeks intervention period and a 6-weeks post-intervention period.
      25 healthy young men will be included in the trial. The pre-intervention period is the
      control period with no treatment. During the intervention period participants will receive
      500 mg of metformin once daily the 1st week, then 500 mg twice daily the 2nd week, 1000 mg +
      500 mg daily the 3rd week and 1000 mg + 1000 mg daily the remaining three weeks.
      Post-interventional investigators will examine gut microbiota of the participants 6 weeks
      after completion of the intervention period.

      MESUREMENTS: Altered composition of gut microbiota as investigated by 16S rRNA sequencing is
      the primary outcome of this study. Secondary outcomes are to investigate changes in metabolic
      and inflammatory markers in blood and fecal samples. Blood, urine, saliva and fecal samples
      will be stored for future studies.
    

Intervention name(s): Metformin
Intervention type(s): Drug
Intervention MeSH terms: Metformin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Gut microbiota; metformin; Metabolism; Metagenomics; Metabolomics
Study of Danicopan in Participants With Normal Kidney Function and Participants With Kidney Dysfunction
Condition: Healthy; Renal Dysfunction
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This was an open-label, nonrandomized, multi-center, single-dose, parallel group study to
      evaluate the effect of severe renal impairment (RI) on the safety, tolerability,
      pharmacokinetics, and pharmacodynamics of danicopan (ACH-0144471) compared to
      demographically-matched healthy participants with normal renal function.
    


Intervention name(s): Danicopan
Intervention type(s): Drug
Intervention description(s): Oral tablet.
Other intervention name(s): ALXN2040; ACH-0144471 (formerly); ACH-4471; ACH4471; 4471
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Danicopan; ALXN2040; ACH-0144471; Renal Impairment; Pharmacokinetics; Pharmacodynamics; Factor D Inhibitor; Safety
Effects of Abdominal Hot Compresses on Indocyanine Green Elimination in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      We investigated, whether abdominal hot compresses effect hepatic blood flow. Our hypothesis
      was, that the hot compresses might either by local vasomotor-reflex or by decreasing the tone
      of the sympathetic nerve system increase hepatic blood flow.
    

Detailed description: 
      Abdominal hot compresses are traditionally used by patients with liver diseases as self help.
      This study investigated the effect of abdominal hot compresses on hepatic blood flow measured
      by elimination of indocyanine green (ICG), a non-toxic green dye. It was presumed, that
      abdominal hot compresses increase hepatic blood flow either by local vasomotor-reflex or by
      decreasing the tone of the sympathetic nerve system.

      In healthy volunteers ICG elimination was measured with and without hot compress at two
      investigations in a weekly interval. At each investigation ICG was injected as bolus after a
      rest period of 10 minutes. After the injection blood was taken in regular intervals for
      analysis of ICG concentration over a period of 40 minutes and half life was calculated.

      The time interval between the investigations was 8 days, the sequence was randomly assigned.
    

Intervention name(s): abdominal hot compress
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: healthy subjects
A Study of LY3325656 in Healthy Participants and Participants With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this trial is to evaluate the safety of single doses of a study drug known as
      LY3325656 that is given orally to healthy participants and participants with type 2 diabetes.
      Information about any side effects that may occur will be collected.

      It will also investigate how much of the study drug gets into the blood stream, and how long
      it takes the body to get rid of it.

      The study consists of two parts. Part A will study healthy participants over approximately 12
      weeks and Part B will study participants with type 2 diabetes over approximately 5 weeks,
      excluding screening. Screening is required within 28 days of the start of the study.
    


Intervention name(s): LY3325656; Placebo; Liraglutide; Sitagliptin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered orally; Administered orally; Administered subcutaneously; Administered orally
Intervention MeSH terms: Sitagliptin Phosphate; Liraglutide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Glucocorticoid Injection in Patients With Lumbar Radicular Pain
Condition: Radiculopathy Lumbar
MeSH terms: Radiculopathy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to demonstrate the efficacy of intramuscular betamethasone
      injection on pain and other clinical parameters in patients with radicular pain due to lumbar
      disc herniation. The investigators also aimed to determine the effects on
      electrophysiological findings.
    

Detailed description: 
      Low back pain is an important health problem that causes difficulties in daily living
      activities, loss of work performance and disability. Some patients with low back pain have
      radicular symptoms due to intervertebral disc herniation. Lumbar radiculopathy is
      characterized by radiating buttock and leg pain in a lumbar nerve root distribution.

      The pathophysiology of radiculopathy is related to compression of the nerve, as well as the
      local release of inflammatory cytokines. Systemic corticosteroids have been used for
      treatment of lumbar radicular pain for a long time. The effects of corticosteroids are
      related to their anti-inflammatory effects, which may help reduce swelling and related
      compression on the affected nerve. Corticosteroids can be used systemically (i.e. oral,
      intravenous, or intramuscular routes) or administered directly into spinal structures through
      injections.

      In the current study, the investigators aimed to demonstrate the efficacy of intramuscular
      betamethasone injection on pain, disability and health related quality of life in patients
      with lumbar radicular pain due to disc herniation. The investigators also aimed to determine
      the effects on electrophysiological findings.
    

Intervention name(s): Glucocorticoids; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Intramuscular injection of single dose of 1 ml betamethasone, Paracetamol (500 mg, 2 times a day); Intramuscular injection of %0.9 isotonic sodium chloride, Paracetamol (500 mg, 2 times a day)
Other intervention name(s): Diprospan
Intervention MeSH terms: Betamethasone dipropionate, betamethasone sodium phosphate drug combination; Glucocorticoids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: glucocorticoid; radicular pain; lumbar radiculopathy
Effect of IATP on Cognitive Functioning in Anxious Older Adults.
Condition: Anxiety Symptoms
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Older adults with anxiety symptoms was found to be associated with greater risk of dementia.
      Interventions targeting signs as early as in the pre-symptomatic phase could be most
      effective in early prevention of dementia. On reviewing the identified non-pharmacological
      interventions, integrated attention training program (IATP) is proposed to target older
      adults with anxiety symptoms in Hong Kong.
    

Detailed description: 
      Older adults with anxiety disorders or symptoms are not in the consideration of management
      for dementia prevention. However, the condition is found to be associated with profound
      negative subsequent decline on both functioning and cognition. While epidemiological studies
      reported high prevalence in older population, its symptoms are often overlooked in the
      presence of other age-related diseases in the community as well as among the health
      professionals. It is expected that cognitive and functional disabilities secondary to this
      condition will pose a significant burden to the existing healthcare system. Therefore,
      targeting anxious older adults for early intervention may help to cut healthcare costs and to
      ensure proactive dementia prevention in the long run. The current proposed intervention
      intends to attenuate the trajectory of cognitive decline at a very early stage and enhance
      existing cognitive function to delay the onset of dementia.

      This study aims to explore whether the use of integrated attention training program (IATP)
      could improve cognitive performance and functioning in older adults with anxiety symptoms. In
      particulars, we aim

        1. To examine the cognitive effect of 4 week integrated attention training program (I) and
           health education (C) in older adults with anxiety symptoms.

        2. To examine the 4 week integrated attention training program (I) and health education (C)
           in alleviating mood symptoms in older adults with anxiety symptoms.

        3. To examine the acceptability and adherence of the proposed intervention.
    

Intervention name(s): Integrated Attention Training Program (IATP); Health Education
Intervention type(s): Other; Other
Intervention description(s): Integrated attention training program (IATP) is a newly developed cognitive training programs that combined relaxation technique with integrated attentional training into daily life activity.; Health educational sessions on health concerns and physical diseases commonly found in old age
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Experimental Human Malaria Infection by PfSPZ
Condition: Malaria
MeSH terms: Infections; Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a single center, varied dose, open label study. A maximum of eighteen volunteers
      will be exposed to live NF54 P. falciparum sporozoites (PfSPZ Challenge) by intradermal
      injection. Volunteers will be divided into three groups of 6 volunteers, each group spaced 25
      days apart (21 days after the last challenge of the last volunteer from the previous dose
      group).
    

Detailed description: 
      In every group on day 1, two volunteers will be injected. On day 3 the remaining four
      volunteers of the group will be injected. Injections in subsequent volunteers are always
      spaced at least one hour apart in any group. Injection of subsequent (groups of) volunteers
      will only commence if the previous injection was shown to be safe. Three different doses of
      PfSPZ will be administered: a dose of 2,500 PfSPZ Challenge (Group 1); a dose of 10,000 PfSPZ
      Challenge (Group 2) if not all volunteers become thick smear positive (TS+) in Group 1; and a
      dose of 25,000 PfSPZ Challenge (Group 3) if there is not 100% TS+ in Group 2. If all
      volunteers in Group 1 (2,500 PfSPZ Challenge) become thick smear positive, then Group 2a will
      receive 1,000 PfSPZ Challenge. If all volunteers in Group 2a become TS+, the volunteers in
      Group 3a will receive 500 PfSPZ Challenge. If all volunteers in Group 2 (10,000 PfSPZ
      Challenge) become TS+, Group 3b will receive 5,000 PfSPZ. If less than 100% of volunteers in
      Group 2a (1,000 PfSPZ Challenge) become TS+ then Group 3c will receive 1,750 PfSPZ Challenge.

      The clinical, biological, parasitological and immunological data of these groups' volunteers
      will be compared. Volunteers and the investigator will not be blinded, but the laboratory
      personnel will be blinded.
    

Intervention name(s): PfSPZ Challenge
Intervention type(s): Biological
Intervention description(s): each volunteer to receive a single dose
Other intervention name(s): aseptic, purified, cryopreserved Plasmodium falciparum sporozoites
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Malaria Challenge; Plasmodium falciparum; Controlled human malaria infection; PfSPZ Challenge
Tear Collection in Adult Volunteers
Condition: Healthy Volunteers
Study type: Observational

Summary: 
      This exploratory study will collect tear samples from adult volunteers for determining and
      quantifying tear composition profiles. No investigational drug will be administered in this
      study.
    


Intervention name(s): Tear Sample Collection
Intervention type(s): Procedure
Intervention description(s): Tear sample collection as per protocol. No investigational drug is administered in this study.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult volunteers without ocular disease.
      
Biospecimen description: 
      Tears
Study of the Safety & Efficacy of Leukine® in the Treatment of Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      A medicine that is FDA-approved for bone marrow stimulation (called Leukine) will be tested
      for its ability to be tolerated by Alzheimer's disease patients and potentially to improve
      their memory.
    

Detailed description: 
      Preliminary preclinical results demonstrated that GM-CSF (Granulocyte macrophage
      colony-stimulating factor, e.g. Leukine®/Sargramostim) rapidly reduced cerebral amyloid
      deposition and completely reversed memory deficits in transgenic mouse models of Alzheimer's
      Disease (AD). To assess the efficacy of GM-CSF in humans, the investigators performed a
      retrospective analysis of a cognition study of human patients undergoing hematopoietic cell
      transplantation for cancer and who garner cognitive impairments from the chemotherapy or
      irradiation. In the patients that received a colony-stimulating factor (CSF) to stimulate the
      bone marrow and recover immune system function, the investigators found that those who
      received GM-CSF (Leukine®/Sargramostim) plus G-CSF (Filigrastim) significantly improved in
      cognitive function as compared to those who received G-CSF alone. These findings combined
      with over two decades of accrued safety data using recombinant human GM-CSF,
      Leukine®/Sargramostim, in elderly leukopenic patients, suggested that Leukine® should be
      tested as a treatment to reverse cerebral amyloid pathology and cognitive impairment in AD.
    

Intervention name(s): Sagramostim; Saline -- placebo comparator
Intervention type(s): Drug; Drug
Intervention description(s): 5 subjects 250 mcg /m2/day Leukine subcutaneously for 5 days/week for three weeks. Data and Safety Monitoring Board will then review data and recommend whether to continue at the same current recommended dose for additional subjects or to reduce the dose by half if excessive leukocytosis occurs; subcutaneous injection
Other intervention name(s): Leukine; Granulocyte-Macrophage Colony-Stimulating Factor; Sterile solution of sodium chloride in water
Intervention MeSH terms: Molgramostim; Sargramostim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Alzheimer's disease; neuropsychological assessment; Granulocyte-Macrophage Colony-Stimulating Factor; Leukine
The Use of 2D and 3D Imaging Modalities and Its Influence on Diagnosis and Treatment Planning in Orthodontics
Condition: Orthodontics; Malocclusion; Impacted Tooth; Cephalometry; Cone-Beam Computed Tomography; Panoramic Radiography
MeSH terms: Malocclusion; Tooth, Impacted
Study type: Observational

Summary: 
      Research questions:

        1. Will the panoramic images derived from cone beam CT data give better diagnostic ability
           than conventional panoramic radiographs?

        2. Will 3D cephalometric analysis offer the orthodontists and surgeons better information
           for treatment planning?

        3. Will the 3D cephalometric analysis give more accurate treatment plan and better
           treatment outcome?

      General hypothesis and special aims

      Overall aims:

        -  To compare 2D versus 3D cephalometric analysis: treatment planning and therapeutic
           outcome.

        -  To determine the accuracy and diagnostic ability and usability of the 3D cephalometric
           analysis.

        -  To evaluate the diagnostic ability and usability of the panoramic image derived from
           cone beam CT data as compared to 2D panoramic images.

        -  To evaluate the value of the cone beam CT data in cephalometric analysing process for
           orthodontic and maxillofacial surgery treatment.

      Hypotheses:

        1. The availability of the 3D cephalometric analysis influences the orthodontic and
           maxillofacial treatment plan and decision, and might change the treatment outcome.

        2. Panoramic images derived from cone beam CT data may provide equal information for
           diagnosis as conventional panoramic images.

        3. Cone beam CT will be able to replace "classic orthodontic imaging" being more time and
           dose efficient and having a beneficial effect on treatment outcome.
    


Intervention name(s): Panoramic radiograph, Cephalometric radiograph; Cone-beam computed tomography (CBCT)
Intervention type(s): Radiation; Radiation
Intervention description(s): 2D images that are used for orthodontic treatment planning; CBCT data will be used in 3D cephalometric analysis softwares
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who are seeking orthodontic and maxillofacial surgery treatments at the University
        Hospital Leuven with the need of conventional panoramic radiographs, cephalometric
        radiographs and cone beam CT images.
The Effect of Pulse Flours on Blood Glucose, Satiety and Food Intake
Condition: Blood Glucose; Eating; Appetite; Food
Study type: Interventional

Summary: 
      Pulse flours represent a fast-growing segment on the functional food market; however, their
      health effects are not well understood. The observational studies and acute trials have
      established the link between frequent consumption of cooked whole pulses (beans, peas,
      lentils and chickpeas) and healthier body weight and improved blood glucose control. However,
      it is not clear whether these effects still remain after the processing of pulses into
      flours. The investigators hypothesized that the baked food products formulated with lentil
      flour of the same particle size as all-purpose wheat flour may reduce postprandial glycaemia
      and elicit a stronger suppression of subjective appetite due to its higher content of protein
      and resistant carbohydrate compared to all-purpose wheat flour. The treatments will be
      formulated either with lentil flour or with all-purpose wheat flour of similar particle size
      or with their combination. The objective of the project is to test the effect of foods
      formulated with lentil flour and/or wheat flour on blood glucose, short-term food intake and
      subjective appetite.
    


Intervention name(s): Food-1; Food-2; Food-3; Food-4
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Baked food made of lentil flour; Baked food made of lentil flour and wheat flour; Baked food made of wheat flour; Potable water (energy and carbohydrate-free control)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Pulses; Flour; Food Intake; Satiety; Blood Glucose