bioihbjkbjnl/mcl2 huggingface dataset:
Physiologic Effect of Spices Ingestion
Condition: Healthy
Study type: Interventional

Summary: 
      Human studies have shown that capsaicin, a compound extracted from chilly peppers, can
      stimulate certain physiologic functions (for example, energy expenditure, thermogenesis,
      lipid oxidation, heart rate, etc.).

      The purpose of this study is to measure the impact of ingesting various spicy molecules on a
      set of physiologic parameters compared to a placebo. The molecules were selected for their
      different sensory properties.

      The results of this study will allow us to implement an effective method for measuring the
      impact of ingesting spices on certain body functions (for example, metabolism and autonomic
      nervous system activity). This study will also allow us to identify the beneficial properties
      of eating certain spices.
    

Detailed description: 
      Primary objective and outcome:

      The main objective of this study is to establish a methodology to evaluate the acute impact
      of spice ingestion on metabolism and autonomic nervous system activity.

      Primary outcomes:

      Impact of the spice on autonomic nervous system activity: Power spectra analysis on heart
      rate variability (HRV) changes during the 90 post ingestive minutes (measured by ECG).

      Impact of the spice on metabolism: Energy expenditure changes during the 90 post ingestive
      minutes (measured by indirect calorimetry).

      As secondary outcomes blood pressure changes and facial temperature changes on specific area
      (nose, cheeks and forehead) will be evaluated. Substrate oxidation (carbohydrates and fat
      utilization) and the respiratory quotient (RQ) will be calculated using indirect calorimetry
      data for energy expenditure measure.
    

Intervention name(s): Spices intake; Placebo
Intervention type(s): Other; Other
Intervention description(s): Each subject had to ingest a single dose of each of the spices and placebo. Recording of outcomes was realized throughout the 90 minutes following ingestion.; Tomato juice intake
Other intervention name(s): 3 different spices; Tomato juice
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Heart rate variability; Resting energy expenditure; Facial thermography; Blood pressure; Spices ingestion
Study of Early Hormone Replacement Therapy on Risk Factors for Sudden Cardiac Death
Condition: Menopausal Women
MeSH terms: Death, Sudden, Cardiac; Death
Study type: Observational

Summary: 
      As an ancillary study to the KEEPS study (see ClinicalTrials.gov Identifier: NCT00154180),
      the primary purpose is to measure effects of estrogen vs. placebo in menopausal women, on
      autonomic function and repolarization; both measured non-invasively via holter monitoring.
    

Detailed description: 
      The parent study KEEPS, will be a randomized, placebo-controlled double blinded, prospective
      trial with two active groups and one placebo group. Only patients enrolled in KEEPS will be
      invited to participate in this ancillary study.Duration of the KEEPS study will be for 4
      years after randomization for each study subject, with assessment of the primary endpoint,
      carotid CIMT, twice at baseline, 12, 24, 36 and 48 months. Ancillary to the KEEPS study,
      patients will undergo holter monitoring at baseline, 24 and 48 months.Data will be analyzed
      after 24 and 48 months (corresponding to data analysis of the primary endpoints.) Holter
      monitors will be put on during the scheduled KEEPS visits, will be worn for 24 hours and will
      be returned the following day. Effects of estrogen on heart rate variability (HRV) and
      repolarization parameters will be evaluated, and also correlated with clinical, quality of
      life, sleep and mood information gathered through the parent study. Anticipated enrollment
      from the parent study at this site is 90 study subjects. This ancillary does not involve the
      use of drugs or investigational devices.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Self-voluntary study subjects participating in the KEEPS parent study which is randomized,
        double-blind, placebo controlled.
      
Keywords: Menopause; Hormone Replacement Therapy; Sudden Cardiac Death
To Investigate the Safety, Pharmacodynamics and Effect on Allergic Reactivity of the Toll-like Receptor 7 (TLR7) Agonist GSK2245035 in Subjects With Respiratory Allergies
Condition: Mild Asthma and Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine the safety and effects on the immune system of
      treatment with GSK2245035 in subjects who suffer from nasal symptoms caused by an allergy to
      pollen or perennial allergen, with or without mild asthma. In addition, the effect of
      treatment with GSK2245035 on the body's allergic response in test situations will be
      explored. Approximately 28 subjects will receive GSK2245035 (up to 14 subjects each receiving
      80 nanograms [ng] GSK2245035 and up to 14 subjects each receiving 20 ng GSK2245035) and 14
      subjects will receive the dummy drug (placebo) during the study. Assignment of a subject to
      GSK2245035 or placebo will be done by chance, like flipping a coin. Neither the subjects nor
      the clinic staff will know whether a subject is being dosed with GSK2245035 or placebo during
      the course of the study. The study will include (a) Screening phase where the eligibility of
      subjects for enrolment will be assessed (b) Treatment phase during which subjects will
      receive either 8 nasal sprays of GSK2245035 80 ng or a matching placebo once weekly for 8
      weeks (each dose will be split between the two nostrils). Subjects participating in this
      study in 2014 will receive a reduced dose of 20 ng i.n. of GSK2245035 once weekly for eight
      administrations (c) Follow-up period where any GSK2245035 induced changes to the immune
      system and the effect of treatment on the body's allergic response in test situations will be
      monitored. The maximum planned study duration for all subjects, including the screening,
      treatment and follow-up periods, is approximately 180 days.
    


Intervention name(s): GSK2245035; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Nasal spray solution, to be given intranasal, 80 ng/20 ng once weekly for 8 weeks; Nasal Spray Solution, to be given intranasal, once weekly for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Repeat Dose Safety; Allergic Asthma; Effect on Allergen Reactivity; Allergic Rhinitis; TLR7 Agonist; Pharmacodynamics
Comparative Bioavailability and Effect of Food on CMX001 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the bioavailability of CMX001 when administered as a
      tablet vs a solution and to determine the effect of a high-fat meal on CMX001
      bioavailability.
    


Intervention name(s): CMX001
Intervention type(s): Drug
Intervention description(s): CMX001 tablet fasted, CMX001 tablet fed, CMX001 solution fasted
Intervention MeSH terms: Brincidofovir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioavailability
Sleep and Pain in Sickle Cell Disease
Condition: Sickle Cell Disease; Sleep Disturbance; Pain
MeSH terms: Dyssomnias; Parasomnias; Anemia, Sickle Cell
Study type: Interventional

Summary: 
      This is a study testing the effects of behavioral sleep interventions on pain and brain
      function in sickle cell disease.
    

Detailed description: 
      The investigators propose to examine whether changes in sleep alter pain and pain-related
      outcomes in adults with Sickle Cell Disease (SCD). As many as 70% of adults with SCD
      experience various sleep disturbances. Pain and sleep are inter-related, such that pain
      disturbs sleep and disturbed sleep amplifies pain and increases risk for developing chronic
      pain. Pain processing occurs in the central nervous system, where nociceptive input can be
      inhibited or facilitated and which can undergo both functional and structural plasticity.
      When plasticity results in amplification of pain, this central sensitization (CS) manifests
      as hyperalgesia, allodynia, and spreading of pain and is an important treatment target in its
      own right. A growing literature implicates central sensitization in SCD, and the
      investigators find a strong association between laboratory-evoked CS and sleep disturbance in
      SCD. The neural substrates involved in pain modulation are often disrupted in chronic pain,
      likely due to the demands pain places on cognitive resources, and similar effects are seen
      with chronic insomnia. It remains unclear whether these changes occur in SCD and if improving
      sleep improves central modulation of pain. The potential for improved sleep to reduce pain
      and CS requires additional investigation, particularly given the significance of sleep
      disturbance as a mutable risk factor. The investigators will conduct a randomized trial in
      which it will be determined whether improvements in sleep reduce pain and alter brain
      processing of pain and cognitive stimuli. The aims are to determine whether treatment of
      sleep improves pain outcomes in SCD and to determine whether treatment of sleep alters
      functional connectivity of cognitive and pain modulatory networks using brain imaging in SCD.
    

Intervention name(s): Behavioral symptom management; Sickle cell disease management
Intervention type(s): Behavioral; Other
Intervention description(s): Individual sessions focused on behavioral and cognitive strategies for managing sleep disturbance, pain, and other symptoms of sickle cell disease; Individual sessions focused on understanding and managing sickle cell disease
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Single Ascending Dose Study of MYK-461 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to establish initial safety, tolerability, pharmacokinetics and
      pharmacodynamics of MYK-461 in human subjects. This is a randomized, double-blind,
      placebo-controlled, sequential group, single ascending (oral) dose study in healthy
      volunteers aged 18-55 years.
    


Intervention name(s): Placebo; MYK-461
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hypertrophic Cardiomyopathy
Long Term Vascular Changes in Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1; Complications; Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The main purpose of this study is to investigate progression of late complications of
      diabetes during the last ten years in a well characterized cohort of type 1 diabetes with a
      long duration of the disease, and to define factors responsible for the progression of late
      complications.
    

Detailed description: 
      Despite intensively research in the field of hyperglycaemia and coronary heart disease in
      type 1 diabetes it is still not known in detail how hyperglycaemia leads to damage of the
      vessels.

      The aims of the present proposal are therefore two-fold:

        1. To study in detail the progression of atherosclerosis (and micro vascular complications)
           in a well characterized cohort of type 1 diabetes with a long duration of the disease.
           This project will be a continuation of the Oslo study, a cohort started in 1982, with
           the last follow-up study in 1999/2000.

        2. To define factors responsible for the progression of coronary heart disease (and micro
           vascular complications) in this cohort.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This project will be a continuation of the previous cohort performed originally from 1982.
        The group or cohorts will be selected from primary care clinic.
      
Biospecimen description: 
      whole blood, serum, white cells, urine, tissue
    
Keywords: Diabetes mellitus, type1; cardiovascular disease; diabetes complications; Glycation end products, advanced
Pharmacokinetics and Pharmacodynamics of TAK-875 in Subjects 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 purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and
      pharmacodynamics of multiple ascending-doses of TAK-875 in subjects with type 2 diabetes
      mellitus.
    

Detailed description: 
      TAK-875 is being developed as an adjunct to diet and exercise to improve glycemic control in
      patients with type 2 diabetes mellitus. Nonclinical data suggest that TAK-875 stimulates
      insulin secretion only at elevated blood glucose levels, with the potential for low
      hypoglycemic side effects.

      The purpose of this phase 1, multiple ascending-dose study is to evaluate the safety,
      tolerability, pharmacokinetics and pharmacodynamics of once daily oral doses of TAK-875 for
      14 days in subjects with type 2 diabetes mellitus.

      Participants will be housed for a total of 8 consecutive overnight stays in the clinic, and
      will undergo oral glucose tolerance tests and standardized meal tests with multiple blood
      sampling throughout their clinic stay.
    

Intervention name(s): TAK-875
Intervention type(s): Drug
Intervention description(s): Randomized, multiple ascending-dose sequence over 14 consecutive days to include the following:
TAK-875 25 mg tablets, orally
TAK-875 50 mg tablets, orally
TAK-875 100 mg tablets, orally
TAK-875 200 mg tablets, orally
TAK-875 400 mg tablets, orally
TAK-875 placebo-matching tablets, orally.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Diabetes Mellitus, Non Insulin Dependent; Diabetes Mellitus, Type II; Type 2 Diabetes Mellitus; Drug Therapy
Pharmacokinetic Study Comparing Aspirin and Aspirin Granules
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the bioequivalence of new formula of aspirin relative to the established
      commercial aspirin plain tablet and aspirin dry granules when taken orally by healthy adult
      subjects
    


Intervention name(s): Acetylsalicylic acid (Aspirin, BAY1019036); Acetylsalicylic acid (Aspirin, BAY1019036); Acetylsalicylic acid (Aspirin, BAYE4465); Acetylsalicylic acid (Aspirin, BAYE4465)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): One oral dose of new formula Aspirin Prototype 1 under fasting conditions; One oral dose of new formula Aspirin Prototype 2 under fasting conditions; One oral dose of Aspirin Plain Tablet under fasting conditions; One oral dose of Aspirin Dry Granules under fasting conditions
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aspirin; Acetylsalicylic Acid
Pilot Efficacy and Safety Study of AQX-1125 in Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the effect of 12 weeks of treatment with
      once daily administration of AQX-1125 compared to placebo on change from baseline in Total
      Lesion Symptom Score in subjects with mild to moderate atopic dermatitis
    

Detailed description: 
      One of the causative factors for the inflammatory response observed in AD is the release of
      chemokines and other chemoattractant factors followed by recruitment of inflammatory cell
      subtypes (10). IL-16, a Langerhans cells (LC)-derived chemoattractant cytokine for CD4+
      cells, RANTES, monocyte chemotactic protein (MCP-4) and eotaxin are overexpressed in
      epidermal keratinocytes from AD subjects and may contribute to the chemotaxis of eosinophils,
      macrophages and Th2-lymphocytes (11).

      Since the activation of SHIP1 by AQX-1125 results in the inhibition of inflammatory cell
      chemotaxis and reduction of pro-inflammatory cytokine synthesis, this study hypothesized that
      AQX-1125 would improve AD.
    

Intervention name(s): AQX-1125; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Synthetic SHIP1 activator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atopic dermatitis; Eczema; AD; AQX-1125; SHIP1
Renal Impairment Study of PF-07321332 Boosted With Ritonavir in Adult Participants With Renal Impairment and in Healthy Participants With Normal Renal Function.
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, non-randomized, open-label, 2-part study to investigate the effect of
      renal impairment on the pharmacokinetics (PK), safety and tolerability of a single oral dose
      of PF-07321332 in combination with the PK boosting agent ritonavir. Participants will be
      selected and categorized into normal renal function or renal impairment groups based on their
      estimated glomerular filtration rate. Part 1: will be conducted in approximately 24
      participants (approximately 8 per group) with stable mild or moderate renal impairment and a
      control group of participants with normal renal function. Part 2 will be conducted in
      approximately 8 participants with stable severe renal impairment.
    


Intervention name(s): PF-07321332/ritonavir
Intervention type(s): Drug
Intervention description(s): PF-07321332 in combination with the PK boosting agent, ritonavir, being developed for the treatment of COVID-19
Other intervention name(s): PF-07321332
Intervention MeSH terms: Ritonavir; Nirmatrelvir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: SARS-CoV-2; COVID-19
Study of Stapled Transanal Rectal Resection (STARR) Surgery in Refractory Constipation Associated With Obstructive Defecation Syndrome (ODS)
Condition: Obstructive Defecation Syndrome; Chronic Constipation; Rectocele; Intussusception
MeSH terms: Rectocele; Intussusception; Syndrome; Constipation
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary purpose of this study is to determine how effective and how durable STARR
      (stapled transanal rectal resection) surgery is in relieving symptoms of intractable
      constipation associated with obstructive defecation syndrome (ODS).
    

Detailed description: 
      Rectocele and rectal intussusception are frequent findings in women but are often
      asymptomatic apart from anatomical defects, which can be seen on vaginal examination. They
      can be associated, however, with refractory constipation that may be best described by the
      terms "Outlet Obstruction" or "Obstructive Defecation Syndrome (ODS)". ODS is characterized
      by a symptom complex, including the feeling of incomplete evacuation associated with the need
      to strain excessively and for external assistance (digital, mechanical or positional
      maneuvers, enemas or suppositories) to aid defecation. Abdominal or rectal pain is also a
      common complaint. Obstetric trauma is also recognized as a contributing factor. However, none
      of these symptoms/factors can be singled out to be pathognomonic for this problem. ODS has a
      prevalence of approximately 12% in the general population.

      For individuals with ODS and related intussusception/rectocele, a variety of surgical
      techniques including abdominal, vaginal, transanal and perineal approaches have been devised.
      The impact of clinical studies to evaluate these techniques has been limited by variability
      of results and lack of comparators. Recently, a new surgical approach was developed by an
      Italian surgeon, A. Longo, and has been evaluated in several European centers. These early
      studies and observations indicate that this new procedure may in fact provide significantly
      better symptom resolution in ODS patients than other available treatments, and warrants
      further study. The procedure is referred to as "Stapled Transanal Rectal Resection (STARR)"
      and this study will assess its effectiveness in a United States population.
    

Intervention name(s): Stapled Transanal Resection (STARR) with Transtar (PROXIMATE®) 33 mm Circular Stapler
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obstructive Defecation Syndrome; Colorectal Surgery; Defecography; Constipation; Rectocele; Intussusception; Quality of Life
Effect of Diabetes Mellitus on Success of Spinal Anesthesia
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      Some of the authors says that diabetes mellitus is a risk factor for spinal anesthesia
      failure. However, that opinion was not determined in a trial. Thus the investigators aimed to
      investigate the effect of diabetes mellitus on spinal anesthesia.
    

Detailed description: 
      The investigators will include all of the patients who will undergo surgery with spinal
      anesthesia. The investigators will observe the patients with or without diabetes mellitus.
      And the investigators will examine the effect of diabetes mellitus on failure of spinal
      anesthesia.
    

Intervention name(s): spinal anesthesia
Intervention type(s): Other
Intervention description(s): non diabetes mellitus
Intervention MeSH terms: Anesthetics
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients who undergoes surgery with spinal anesthesia
      
Keywords: failure; spinal anesthesia