bioihbjkbjnl/mcl2 huggingface dataset:
D-chiro-inositol and Endometrial Thickness
Condition: Endometrial Diseases
MeSH terms: Uterine Diseases
Study type: Interventional

Summary: 
      Investigation of the effects of D-chiro-inositol supplementation in women with altered
      endometrial thickness.
    


Intervention name(s): DCI
Intervention type(s): Dietary Supplement
Intervention description(s): Oral supplementation with D-chiro-inositol once daily
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Opt-IN: Optimization of Remotely Delivered Intensive Lifestyle Treatment for Obesity
Condition: Weight Loss
MeSH terms: Weight Loss
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The overall objective of the proposed research is to use an innovative methodological
      framework, the Multiphase Optimization Strategy (MOST), to design, for the first time, an
      optimized, scalable version of a technology-supported intensive lifestyle intervention (INLI)
      for obesity. MOST involves highly efficient randomized experimentation to assess the effects
      of individual treatment components, and thereby identify which components and component
      levels make important contributions to the overall program effect on weight loss. This
      information then guides assembly of an optimized treatment package that achieves target
      outcomes with least resource consumption and participant burden. Because the intervention
      strategies being tested minimize in-person coaching and leverage technology that participants
      already own, the new optimized intervention, to be called Opt-IN, will be more scalable than
      traditional INLIs. Opt-IN will thus enjoy greatly increased reach, and enable significant
      progress in the fight against obesity.
    

Detailed description: 
      The goal of the proposed study is to determine the optimal composition of a technology
      supported intervention for obesity that minimizes expense and burden to participants, while
      achieving 6 month weight loss outcomes comparable or superior to those achieved by the
      current full cost, full burden form of INLIs. All intervention components to be examined were
      selected based on the Opt-IN model's prediction that they enhance behavioral adherence to
      weight regulation via the designated pathways. The five components to be tested will be: (1)
      coaching intensity (12 vs. 24 phone sessions), (2) text messaging (No vs. Yes), (3) progress
      report to participant's primary care provider (No vs. Yes), (4) recommendation to use meal
      replacements (No vs. Yes), (5) training participants' self-selected buddies to be supportive
      (No vs. Yes).
    

Intervention name(s): 12 Telephone Coaching Sessions; 24 Telephone Coaching Sessions; Report to Primary Care Physician; Text Messages; Recommendations to use meal replacements; Buddy Training
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will receive 12 telephone coaching sessions; Participants will receive 24 telephone coaching sessions; Participants will have a report detailing their weight loss progress sent to their primary care physician; Participants will receive regular text messages; Participants will receive recommendations from their coach to use meal replacements; Participants will have a buddy that will be trained via webinars to be a supportive buddy
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Angiotensin Converting Enzyme Activity on Exercise Training Sensitivity
Condition: Exercise; Angiotensin-Converting Enzyme Inhibitors
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      The phenotype based on the insertion/deletion (I/D) polymorphism of the human angiotensin
      converting enzyme (ACE) gene has been associated with individual training response. Briefly,
      intervention studies have demonstrated an 11-fold greater training-induced improvement in
      muscular endurance for ACE I/I homozygotes compared to ACE D/D homozygotes.

      Importantly, the ACE I/D polymorphism causes large inter-individual differences in serum ACE
      activity. Because the ACE D/D genotype is characterized by high plasma ACE activity and
      potentially blunted endurance exercise training response, it appears likely that ACE
      inhibitors (ACEi) have the potential to improve the outcome of exercise training for ACE D/D
      homozygotes.

      Thus, in the present study the investigators apply a randomized double-blind
      placebo-controlled longitudinal design to investigate whether pharmacological inhibition of
      ACE activity can amplify the exercise training response in healthy humans carrying either the
      ACE D/D or ACE I/I genotype.

      The study hypothesis is that inhibition of ACE activity in healthy humans with the ACE D/D
      genotype will amplify the health beneficial effects of exercise training while this is not
      the case in ACE I/I homozygotes.
    


Intervention name(s): Enalapril; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will be assigned to daily administration of ACE inhibitors (Initially 5 mg Corodil® 'Enalapril' daily followed by up to 20 mg daily dependent on the blood pressure response) combined with an 8-week training period.; Participants will be assigned to daily administration of placebo (5-20 mg CaCO3) combined with an 8-week training period.
Intervention MeSH terms: Enalapril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Adaptation, Physiological; Genotype; Polymorphism, Genetic; Enalapril; Physiological Effects of Drugs
Study in Patients With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine which dose of the investigational drug is safest
      and most effective compared to the control group.
    


Intervention name(s): Formoterol Fumarate
Intervention type(s): Drug
Intervention MeSH terms: Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Asthma; Pediatric; Formoterol Fumarate; Foradil
Does Auricular Acupuncture Improve Tolerance to Electromyography (EMG) Testing?
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      Needle Electromyography (EMG) is an important test used to assess muscle and nerve function,
      but the test can be uncomfortable. It is currently not standard practice to provide any
      pain-relieving intervention for this procedure. The purpose of this research study is to
      determine whether auricular (ear) acupuncture will make EMG testing less painful.
    


Intervention name(s): auricular acupuncture
Intervention type(s): Other
Intervention description(s): Experimental group to receive ear needles in the Battlefield Acupuncture points.
Sham group to receive ear needles at points thought to be ineffective but standardized.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Pain; Electromyography; Acupuncture; Randomized controlled trial; Rehabilitation
Comparison Study Between Protopic (Tacrolimus Ointment) and Elidel (Pimecrolimus Cream) in Treating Pediatric Patients With Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparison of Protopic Ointment to Elidel Cream to assess the safety and efficacy in
      pediatric patients with Atopic Dermatitis
    

Detailed description: 
      This is a two arm, randomized, investigator blinded study to compare Protopic Ointment to
      Elidel Cream in treating pediatric patients with moderate to severe Atopic Dermatitis
    

Intervention name(s): tacrolimus ointment; pimecrolimus cream
Intervention type(s): Drug; Drug
Intervention description(s): topical; topical
Other intervention name(s): Protopic; FK506 ointment; Elidel
Intervention MeSH terms: Pimecrolimus; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Atopic Dermatitis; Protopic; Pediatric
Effects of Excess Energy Intake on Metabolic Risk
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The prevalence of obesity has reached epidemic proportions and is associated with the
      development of insulin resistance and type 2 diabetes (T2DM). A unifying theme has emerged
      over the past few years suggesting that lipid oversupply to metabolic organs responsible for
      glucose regulation leads to insulin resistance. Fitting with this, we and others have shown
      that increased lipid accumulation within skeletal muscle and/or liver is associated with
      impaired glucose uptake. However, the underlying mechanisms that mediate changes in muscle
      lipid metabolism are not yet known. The overall aim of this project is to examine metabolic
      effects of experimental weight gain in lean and overweight individuals with and without a
      genetic predisposition to type 2 diabetes. We hypothesise that lean subjects will increase
      fatty acid oxidation and upregulate mitochondrial oxidative capacity in muscle following
      overfeeding to protect against body weight gain and insulin resistance, but overweight
      subjects with a genetic predisposition to T2DM will have a defect in this ability.
    


Intervention name(s): Nutritional
Intervention type(s): Other
Intervention description(s): Overfeeding high fat diet for 28 days
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
A Study to Evaluate the Efficacy and Safety of Ansofaxine Hydrochloride Extended-release Tablets in the Treatment of Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder (MDD)
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if LY03005 is effective and safe in improve MADRS
      score, as compared to placebo (no medicine) in participants with Major Depressive Disorder
      (MDD)
    

Detailed description: 
      The study consisted of two periods: a screening period of 1 week and a double-blind treatment
      period (8 weeks). After the screening period, 588 enrolled subjects were randomized into one
      of 3 study groups in the 1:1:1 ratio, 2 LY03005 treatment groups with different dose or 1
      placebo group. Subjects were given investigatory drug or placebo according to the protocol,
      followed up at the end of 1, 2, 4 6, and 8 weeks.
    

Intervention name(s): LY03005 extended-release tablet; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): orally once a day; orally once a day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Guided Metabolic Detox Program
Condition: Detoxification Response
Study type: Interventional

Summary: 
      Adequate antioxidant supply is essential for maintaining metabolic homeostasis and reducing
      oxidative stress during detoxification. The emerging evidence suggests that certain classes
      of phytonutrients can help support the detoxification process by stimulating the liver to
      produce detoxification enzymes or acting as antioxidants that neutralize the harmful effects
      of free radicals. This study was designed to examine the effects of a guided 28-day metabolic
      detoxification program in healthy adults. The participants were randomly assigned to consume
      a whole food, multi-ingredient supplement (education and intervention) or control (education
      and healthy meal) daily for the duration of the trial.
    

Detailed description: 
      In this study, the focus is on a cohort of healthy adults enrolled in a guided detoxification
      program that included a healthy diet education session with or without 28-day nutritional
      supplementation with a whole food, proprietary multicomponent blend. The primary objective
      was to determine the improvement in quality of life by a validated self-reported wellness
      questionnaire known as Promis Global 10. The secondary outcomes were to quantify the
      functional markers of metabolic detoxification in blood and urine compared to the study
      baseline to understand the efficacy of the study formulation as part of 28-day nutritional
      supplementation with a whole food, proprietary multicomponent blend.
    

Intervention name(s): SP Detox Program
Intervention type(s): Dietary Supplement
Intervention description(s): The production use and disposal of toxic chemicals and synthetic materials have increased the risk of exposure to health-threatening toxins. Causal relationships between toxic chemicals and diseases have been well established. However, many patients endure chronic symptoms that are associated with exposure to toxins before advanced stages of specific diseases are realized. Thus, there is a great demand for noninvasive laboratory tests that can provide timely assessment of chemical exposure and the capability of hepatic detoxification
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Detoxification; Whole Food Vitamins; Glutathione; liver; antioxidants; SOD; GST
A Single-Center Exploratory Study to Assess the Activity of CRx-197-002 in Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This will be a phase 2a single-center, randomized, blinded, vehicle-controlled exploratory
      study to assess the activity and safety of CRx-197 in subjects with plaque psoriasis.
      Approximately 20 male or female subjects with chronic plaque type psoriasis, 18 to 70 years
      of age, will be included in this study.

      All subjects with stable psoriatic plaques will receive all of the following treatments each
      in a separate test field, once each day for four weeks under occlusion:

        -  CRx-197 high dose topical cream (0.1% nortriptyline HCl +0.3% loratadine)

        -  CRx-197 low dose topical cream (0.1% nortriptyline HCl + 0.1% loratadine)

        -  0.1% nortriptyline HCl topical cream

        -  0.005% calcipotriol topical cream

        -  Vehicle of CRx-197 topical cream (placebo)
    


Intervention name(s): CRx-197; CRx-197; Nortriptyline; Calcipotriol; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): CRx-197 high dose topical cream (0.1% nortriptyline HCl +0.3% loratadine); CRx-197 low dose topical cream (0.1% nortriptyline HCl + 0.1% loratadine); 0.1% nortriptyline HCl topical cream; 0.005% calcipotriol topical cream; Vehicle of CRx-197 topical cream (placebo)
Intervention MeSH terms: Nortriptyline; Calcipotriene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psoriasis; CRx-197; nortriptyline; loratadine; CombinatoRx; Dermatology; Erythema; Pruritus
A Study Investigating the Excretion Balance, Pharmacokinetics and Metabolism of a Single Oral Dose of [14C]-Labeled Risdiplam (RO7034067) in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, non-randomized study investigating the excretion balance, PK and
      metabolism of a single oral dose of [14C]-labeled Risdiplam (RO7034067) in healthy male
      participants. This study will assess the characterize mass balance, routes and rates of
      elimination of [14C]-labeled Risdiplam (RO7034067), using conventional analytical methods and
      assess the pharmacokinetics of total drug related [14C]-radioactivity, Risdiplam (RO7034067)
      and its metabolite(s).
    


Intervention name(s): [^14C]-Risdiplam
Intervention type(s): Drug
Intervention description(s): [^14C]-Risdiplam 18 mg oral solution with approximately 0.75 megabecquerel MBq (20 microcuries [μCi]) of [14C]-labeled Risdiplam.
Intervention MeSH terms: Risdiplam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Trifluridine and Tipiracil Tablets in Colorectal Cancer Patients
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Trifluridine and Tipiracil Tablets is a nucleoside anti-metabolic and anti-cancer compound
      developed by Taiho (Dapeng) Co., Ltd., Japan, for the treatment of advanced colorectal cancer
      that inoperable resection, and progressed or relapsed after standard treatment. This study
      mainly evaluates bioequivalence, safety and tolerance of Trifluridine and Tipiracil Tablets
      in colorectal cancer patients.
    


Intervention name(s): Trifluridine and Tipiracil Tablets; TAS-102
Intervention type(s): Drug; Drug
Intervention description(s): Trifluridine and Tipiracil Tablets given 20mg orally once under fasting or postprandial conditions per cycle; TAS-102 given 20mg orally once under fasting or postprandial conditions per cycle
Intervention MeSH terms: Trifluridine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
INTRuST Structured Assessment For Evaluation of TBI (SAFE-TBI)
Condition: Brain Injuries, Traumatic
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Observational

Summary: 
      The current study will evaluate the initial reliability and validity of a new instrument, the
      INTRuST Structured Assessment for Evaluation of TBI (SAFE-TBI), in three samples of Operation
      Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) veterans. The
      SAFE-TBI is a relatively brief measure developed by INTRuST consortium investigators and
      designed to be given by a trained administrator. It allows for a determination of the level
      of evidence for exposure to a mild traumatic brain injury (TBI) using the following
      categories: Strong, Moderate, Weak, or No Evidence of mild TBI. The first objective is to
      determine the reliability (both test-retest and inter-rater) in a sample of 100 veterans
      recently returned from deployment at Joint Base Lewis-McChord and Fort Bragg (Cohort 1), who
      have screened positive for TBI on the Post-Deployment Health Assessment. The second objective
      is to determine the concordance between the SAFE-TBI and the VA TBI Screen in 100 OEF/OIF/OND
      veterans within the Northern New England VA Research Consortium (Cohort 2). The third
      objective, to be carried out in a sample of 200 Walter Reed National Military Medical Center
      (WRNMMC) and Fort Belvoir Community Hospital OEF/OIF/OND patients (Cohort 3), is to determine
      the sensitivity and specificity of the SAFE-TBI using the INTRuST study "Brain Indices of
      Risk for Posttraumatic Stress Disorder after Mild Traumatic Brain Injury" initial evaluation
      as the "gold standard" for TBI assessment.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cohort 1: Active duty OEF/OIF/OND military personnel ages 18-60 who have recently screened
        positive for TBI following deployment.

        Cohort 2: OEF/OIF/OND veterans ages 18-60 who have recently screened positive for TBI.

        Cohort 3: Participants ages 18-60 in the INTRuST Consortium Brain Indices Study at WRNMMC
        or FBCH.
      
Keywords: brain injuries, traumatic; military personnel; classification; diagnosis; instrumentation
Evaluation of Salivary Biomarker Levels of Individuals With Different Periodontal Diseases
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases
Study type: Interventional

Summary: 
      The aim of this study is; detection of leucine rich α-2 glycoprotein1 (LRG1), c-reactive
      protein (CRP) levels in saliva samples of periodontally healthy, gingivitis and periodontitis
      patients and the possible correlation between these values and clinical parameters of
      periodontal diseases. Materials and methods: Samples of saliva were obtained from 60
      systemically healthy non-smoker individuals with periodontitis (P, n=20), gingivitis(G, n=20)
      and healthy periodontium (S, n=20). Full-mouth clinical periodontal measurements including
      probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), gingival
      index (GI) and plaque index (PI) were also recorded. Enzyme-linked immunosorbent assay
      (ELISA) was used to determine LRG and CRP levels in the biological samples.
    


Intervention name(s): saliva obtaining
Intervention type(s): Diagnostic Test
Intervention description(s): The patient was asked to sit upright and tilt his/her head forward to collect saliva samples. İn this way, unstimulated saliva was allowed to accumulate in the floor of the mouth. The accumulated saliva was collected in a sterile container. It was then transferred to a propylene tube. The tubes were centrifuged and the clear part at the top of the tube was taken with a sterile syringe and transferred to a different propylene tube with 0.5 ml in each tube. Tubes were stored at -80ºC until the day of analysis.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: According to full-mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL),bleeding on probing (BOP), gingival index (GI) and plaque index (PI) samples of saliva were obtained from 60 systemically healthy non-smoker individuals with periodontitis (P, n=20), gingivitis(G, n=20) and healthy periodontium (S, n=20).
Masking: None (Open Label)
Primary purpose: Diagnostic