bioihbjkbjnl/mcl2 huggingface dataset:
Ketones and Muscle Protein Synthesis
Condition: Ketosis; Regulation of Muscle Protein Synthesis
MeSH terms: Ketosis
Study type: Interventional

Summary: 
      Ketones are natural substances normally produced by the body during prolonged fasting and
      starvation, or in response to a "ketogenic" diet to be used as fuel by the brain and muscles.
      Ketones are therefore similar to dietary proteins, carbohydrates and fats since they
      represent a source of energy for the body. In addition to serving as a source of energy,
      ketones have also been shown to stimulate increased rates of muscle protein synthesis in
      humans.

      The ingestion of dietary protein is well established to stimulate an increase in the rate of
      protein synthesis in skeletal muscle. The rate of muscle protein synthesis can be maximized
      following the intake of 20g of protein. As a result, smaller doses of protein (i.e. 10g)
      represent a sub-optimal dose of protein because there is still room for improvement
      concerning muscle protein synthesis.

      Recently ketone-containing food products have become available that elevate ketone levels in
      the body without the need for ketogenic diets or prolonged fasting. Therefore, the purpose of
      this study is to measure skeletal muscle protein synthesis rates after ingesting the
      following:

        1. Ketone monoester

        2. Ketone monoester supplemented with sub-optimal dose of whey protein

        3. Sub-optimal dose of whey protein

      It is hypothesized that muscle protein synthesis rates will increase following the ingestion
      of a ketone-containing beverage. Further, muscle protein synthesis rates will be enhanced
      when the ketone-containing beverage and sub-optimal protein dose are taken together.
    


Intervention name(s): Ketone; Ketone + Protein; Protein
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Ketone monoester supplement (R)-3-hydroxybutyl (R)-3-hydroxybutyrate based on participants' body weight (0.36g/kg body weight)
Isocaloric carbohydrate control: dextrose + vanilla flavouring; Ketone monoester supplement (R)-3-hydroxybutyl (R)-3-hydroxybutyrate based on participants' body weight (0.36g/kg body weight)
10g Whey Protein
L-[ring-2H5]-phenylalanine tracer (enriched to 4%); Isocaloric carbohydrate control: dextrose + stevia
10g Whey Protein
L-[ring-2H5]-phenylalanine tracer (enriched to 4%)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ketone; protein metabolism; muscle
Nutrient and Immunity Status in Children Aged 3-5 Years Consuming Their Habitual Diet With or Without Fortified Milk
Condition: Nutritional Status; Child Nutrition Sciences; Toddlers
Study type: Interventional

Summary: 
      This study compares the status of key micronutrients (vitamins A, C, D, E, and zinc) in young
      children given investigational fortified milk versus young children consuming their habitual
      pattern of beverage intake (milk and non-milk beverages).
    

Detailed description: 
      Hypothesis that Vitamin A, C, D, E and zinc status of children consuming 2 servings / day of
      fortified milk for 16 weeks will be better than those of children consuming their habitual
      pattern of beverage intake (milk and non-milk beverages, juices, sugar-sweetened drinks) for
      the same duration. This is based on previous study findings that (i) the toddler's and
      preschooler's diet, in reality, are often not optimal, putting toddlers and preschool age
      children at risk of insufficient intakes of several nutrients, and (ii) consuming fortified
      milk supplemented with these nutrients might provide optimal intakes of these nutrients.
    

Intervention name(s): Fortified milk
Intervention type(s): Other
Intervention description(s): Commercially available milk-based fortified beverage that has an updated profile of key micronutrients along with appropriate levels of protein and other macro- and micro- nutrients, in accordance with global and local nutritional recommendations
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Study of Daclizumab in Patients With Chronic, Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate an investigational medication to treat chronic
      persistent asthma. The research is being conducted at up to 22 clinical research sites in the
      US and is open to both men and women ages 18 to 70 years old. Participants in the study will
      have a number of visits to a research site over a 10-month period. All study-related care and
      medication is provided to qualified participants at no cost: this includes all visits,
      examinations and laboratory work.
    


Intervention name(s): Daclizumab
Intervention type(s): Drug
Intervention MeSH terms: Daclizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Asthma; Daclizumab; anti-Tac monoclonal antibody; anti-IL-2; Zenapax
Titrating-Dose of Lonafarnib in Combination With Ritonavir
Condition: Chronic Delta Hepatitis
MeSH terms: Hepatitis D; Hepatitis D, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      A phase 2, open-label study to evaluate the safety, tolerability, pharmacokinetics, and
      pharmacodynamic activity of titrating-dose lonafarnib/ritonavir in patients chronically
      infected with hepatitis delta virus (HDV)
    

Detailed description: 
      This is a Phase 2 study of 24 weeks of treatment with a dose-titration regimen of
      lonafarnib/ritonavir in up to 15 patients chronically infected with HDV: lonafarnib starting
      at 50 mg twice daily (BID) in combination with ritonavir 100 mg BID and escalating lonafarnib
      as tolerated.

      The duration of the study for each patient is approximately 13 months (up to 4 weeks for
      screening, 24 weeks of treatment, 4 weeks for the primary follow-up visit, and monthly safety
      follow-up visits for 5 months thereafter). The 6-month follow-up after the last dose of study
      drug is designed to allow evaluation of the clinical and virologic course after completion of
      the 24-week Treatment Period.
    

Intervention name(s): lonafarnib; Ritonavir
Intervention type(s): Drug; Drug
Intervention description(s): antiviral farnesyltransferase inhibitor; Cytochromes P450 3A4 inhibitor used to boost lonafarnib
Other intervention name(s): EBP994; Sarasar; Norvir
Intervention MeSH terms: Ritonavir; Lonafarnib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of TD-1211 in Subjects With Opioid-Induced Constipation
Condition: Opioid Induced Constipation
MeSH terms: Constipation; Opioid-Induced Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and
      Efficacy of TD-1211 in Subjects with Opioid-Induced Constipation
    


Intervention name(s): TD-1211; TD-1211; TD-1211; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): once daily; Once daily; Once daily; Once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Opioid induced constipation; OIC; Constipation; Opioid side effects; Morphine induced constipation; Opioid therapy
Methionine and Cysteine Restriction in Humans
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The aim of this study is to examine the effect of methionine and cysteine restriction on
      energy and macronutrient metabolism in overweight human subjects
    

Detailed description: 
      The sulfur-containing amino acid methionine and its downstream metabolite cysteine has been
      associated with fat mass in animal studies and human observational studies. Some of the
      proposed mechanisms include an association with lipogenesis, insulin sensitivity and
      disrupted energy metabolism.

      The overall aim of this project is to evaluate the effects of a diet low in methionine and
      cysteine on markers of lipids, amino acids, glucose and other biomarkers related to energy
      metabolism, including transcriptomic and protein expression data from adipose tissue and
      lymphocytes. Overweight and obese but otherwise healthy volunteers will be randomized to
      receive a diet either low, moderate or high in methionine and cysteine concentrations for 1
      week.

      This is a pilot study that may be considered an extension of NCT02647970. In addition to the
      primary and secondary outcomes we will evaluate the feasibility of the intervention and
      procedures.
    

Intervention name(s): Low met/cys diet; Moderate met/cys diet; High met/cys diet
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Dietary intervention with low contents of methionine and cysteine; Dietary intervention with moderate contents of methionine and cysteine; Dietary intervention with high contents of methionine and cysteine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Methionine; Cysteine; Energy metabolism; Sulfur amino acids
Selecting Specific Bio-markers and Researching Mechanisms of Immune Regulation From Inhalation Injury and Traumatic Lung Injury Based on Single Cell Sequencing Technology
Condition: Traumatic Lung Injury; Inhalation Injury
MeSH terms: Respiratory Aspiration; Lung Injury; Respiratory Distress Syndrome; Wounds and Injuries
Study type: Observational

Summary: 
      The goal of this observational study is to profile the circulating immunological traits of
      patients with traumatic lung injury (TLI) and inhalation injury (ILI),providing a new
      direction for the depth research of the pathogenesis, and providing new immune-related
      targets for diagnosis of the severity of lung injury and treatment.

      The investigators performed scRNA-seq of neutrophil and peripheral blood mononuclear cells
      (PBMCs) from 10 ml fresh circulating blood from 3 patients with TLI and 3 patients with ILI
      at longitudinal timepoints,as well as peripheral blood from 3 health controls(HCs).
    

Detailed description: 
      The investigators performed single-cell transcriptomic sequencing (BD Rhapsody) on neutrophil
      and PBMCs extracted from the fresh circulating blood from 3 patients with TLI and 3 patients
      with ILI at longitudinal timepoints,as well as peripheral blood from 3 health controls(HCs).
      Three time points are picked by clinical conditions of patients with TLI or ILI: day 1 post
      hospital admission, day 3 post hospital and the day before discharged which matched to acute
      stage,progressive stage and convalescence.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        3 patients with TLI and 3 patients with ILI age from 18 to 90 years old, admission within
        24h after injury and diagnosed as traumatic lung injury by 2 surgeons on account of injury
        history and chest CT images. As well as peripheral blood from 3 health controls(HCs) who
        have no smoking history.
A Study to Access the Efficacy and Safety of Meloxicam in Patients With Osteoarthritis of the Knee
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      To Access the Efficacy and Safety of Meloxicam 7.5mg once daily over a treatment period of 56
      days
    


Intervention name(s): Meloxicam
Intervention type(s): Drug
Other intervention name(s): Mobic
Intervention MeSH terms: Meloxicam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Frequency Analysis of Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Observational

Summary: 
      The purpose of this study is to determine if coronary artery disease can be detected using an
      electronic, acoustic recording instrument. The presence or absence of abnormal pathology will
      be confirmed by diagnostic angiography as part of the normal patient care at this
      institution.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients presenting to the University of Minnesota Medical Center (UMMC) Fairview Clinics,
        Physicians (UMP) or the Redwing, Minnesota clinic
      
Keywords: acoustic; digital; sound; vibration; coronary; auscultation; artery; diagnosis
Tenofovir Disoproxil Fumarate (TDF) 300mg 3 Years RD Therapy Chinese Chronic Hepatitis B (CHN) CHB Multiple Nucleos(t)Ide Analogues (NAs) Failure Points Pts PH4 PMS Study
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a phase IV, single-arm, open-label, multi-centre study to assess the efficacy of TDF
      in Chronic hepatitis B (CHB) subjects following failure of multiple Nucleos(t)ide analogues
      (NAs). The study will enrol 200 CHB subjects following failure of multiple NAs. Subjects will
      be assessed for eligibility at a screening visit, with eligible subjects returning for a
      baseline assessment after approximately 4 weeks (Screening phase). In the treatment phase all
      enrolled subjects will receive open label TDF at a dose of 300 milligrams (mg) orally once
      daily. All the eligible study subjects will undergo safety and efficacy assessments every 12
      weeks for a total of 14 visits. Tenofovir disoproxil fumarate, the oral pro-drug of tenofovir
      (TFV), is a nucleotide analogue that inhibits viral polymerases by direct binding and after
      incorporation into deoxyribonucleic acid (DNA), by termination of the DNA) chain. TDF is a
      highly potent treatment in treatment-naïve and lamivudine (LAM) resistant CHB patients. The
      purpose of our study is to evaluate the efficacy of TDF treatment in Chinese CHB patients
      following failure of multiple NAs. In addition, the study will also explore the relationship
      of baseline factors and early HBV DNA suppression to long-term virological response. The
      efficacy of TDF in multi-drug resistant patients will be analysed separately. The data
      generated by this study could then be used to optimize the clinical application of TDF and
      provide new evidence for management of the HBV infections following failure of multiple NAs.
      The result of this study will help Chinese physicians better manage the CHB patients
      following failure of multiple NAs.
    


Intervention name(s): Tenofovir disoproxil fumarate
Intervention type(s): Drug
Intervention description(s): Tenofovir disoproxil fumarate tablets supplied will be white, almond-shaped, film-coated tablets containing 300 mg of TDF. Each tablet contains the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinised starch, croscarmellose sodium, and magnesium stearate.
Intervention MeSH terms: Tenofovir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Hepatitis B; Tenofovir disoproxil fumarate; Failure of multiple NAs treatment
Young ESUS Patient Registry
Condition: Embolic Stroke of Undetermined Source
MeSH terms: Stroke; Embolic Stroke
Study type: Observational [Patient Registry]

Summary: 
      This study seeks to determine the clinical characteristics of young ESUS patients using
      diagnostic criteria of the Cryptogenic Stroke / ESUS International Working Group, and to
      determine the rates of stroke recurrence, death, and hospital readmission in a contemporary
      cohort of young ESUS patients during follow-up of up to 18 months.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients presenting to hospital-based stroke unit with an ESUS Stroke
      
Keywords: Stroke; Ischemic Stroke; Cryptogenic Stroke; Embolic stroke of undetermined source; ESUS; Cerebrovascular Disease
A Pilot Randomized Trial of Pain Neuroscience Education in the Rehabilitation After Arthroscopic Rotator Cuff Repair
Condition: Rotator Cuff Injuries
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the effects of a 8-week pain neuroscience education
      programme compared to a biomedical education programme on the rehabilitation of patients who
      undergo arthroscopic rotator cuff repair. Outcome measures included pain intensity, patients'
      attitudes and beliefs about pain, disability and quality of life.
    

Detailed description: 
      This was a single-blinded, randomized parallel study. Twenty- nine patients who undergo
      arthroscopic rotator cuff repair took part in a multimodal physiotherapy programme and were
      allocated to two groups. Patients in the experimental group - PNE (n= 16) received multimodal
      physiotherapy along with pain neuroscience education, and the control group- PME (n=13)
      received multimodal physiotherapy along with biomedical education. The multimodal treatment
      included 1-hour sessions 3 times per week for 8 weeks (24 sessions). In addition, the
      education component (PNE, PME) consisted of 4 education sessions of 30 minutes duration, on a
      one-to-one basis, once per week at the start of the programme.

      Physiotherapists involved in the delivery of the interventions were previously trained on
      both, the theoretical and practical aspects related to the protocols of multimodal
      physiotherapy and specially on the education component.

      Outcome measures included pain intensity (pain intensity numerical rating score),
      catastrophizing, kinesiophobia, disability and quality of life.
    

Intervention name(s): Pain Neuroscience Education; Biomedical Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients received 24 sessions, in an 8-week period, of multimodal physiotherapy (therapeutic heat, manual therapy and exercises) along with four sessions of pain neuroscience education. The latter was focused on the influence of psychosocial factors in the experience of pain, differences between acute and chronic pain and central-peripheral awareness.; Patients received 24 sessions, in an 8-week period, of multimodal physiotherapy (therapeutic heat, manual therapy and exercises) along with four sessions of biomedical education. The latter was focused on the anatomy and pathomechanics of the shoulder.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomly assigned to groups by using an online random generator. This procedure was conducted by an external assessor. The allocation concealment strategy included the use of sealed-opaque and consecutively numbered envelopes.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Zainidip in Renal Artery Stenosis
Condition: Hypertension
MeSH terms: Renal Artery Obstruction
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the efficacy of renal artery stent combined with standardized medical therapy as
      treatment for renal artery stenosis.
    


Intervention name(s): stent; Aspirine; Clopidogrel; Lercanidipine
Intervention type(s): Device; Drug; Drug; Drug
Intervention description(s): patients receiving renal artery stenting for renal artery atherosclerosis; 100mg Qd; 75mg Qd; 10-20mg Qd
Intervention MeSH terms: Lercanidipine; Clopidogrel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cannabidiol: a Novel Intervention for Cannabis Use Problems?
Condition: Cannabis Use Disorder
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to investigate a novel treatment for cannabis dependence:
      cannabidiol. Between 96 and 168 young people who want to quit cannabis and meet criteria for
      moderate cannabis use disorder (DSM-5) will be recruited from the community. Stage one aims
      to identify the Most Effective Dose (MEDmg) of oral cannabidiol for reducing cannabis use
      over four treatment weeks. Stage two will determine whether the MED identified in stage 1 can
      offer an effective treatment for cannabis dependence.
    


Intervention name(s): Cannabidiol; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cannabidiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Phase 1 Pharmacokinetic Study of Single-Ascending Doses of Intravenous Nafithromycin in Healthy Adult Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, double-blind, single-center, placebo-controlled,
      sequential-cohort study in at least 60 healthy adult male and female subjects. Subjects in
      Cohorts 1 through 5 will be randomly assigned in an 8:2 allocation to receive active or
      placebo treatments. Subjects in Cohort 6 will be randomly assigned in a 1:1 allocation to
      receive an IV dose of nafithromycin and a single oral dose of nafithromycin in each crossover
      period. Subjects in each of Cohorts 1, 2, and 3 will receive a single dose of 100, 200, or
      400 mg, respectively, of nafithromycin or matching placebo on Day 1.
    


Intervention name(s): Nafithromycin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100, 200, or 400 mg of nafithromycin; IV matching placebo
Other intervention name(s): Matching IV placebo
Intervention MeSH terms: Nafithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Connective Tissue Motion Measure
Condition: Low Back Pain
MeSH terms: Low Back Pain
Study type: Observational

Summary: 
      The goal of this project is to develop a biomarker - the Connective Tissue Motion Measure
      (CTMM) -quantifying the functional behavior of perimuscular connective tissues.
    

Detailed description: 
      The differential motion between specific connective tissue strata will be measured during
      tissue displacement (linear oscillation) initiated by a computer-controlled needle stimulus
      tool (NST). The CTMM will be suitable as an outcome measure for mechanistic and clinical
      studies of CAM interventions. The CTMM also will potentially serve as a clinical diagnostic
      and treatment-monitoring tool for manual therapists, acupuncturists, and CAM clinicians
      interested in assessing the functional status of a patient's connective tissue.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Community Sample