bioihbjkbjnl/mcl2 huggingface dataset:
Microgravity Effects on Co-cultured Vascular Cells Types
Condition: Microgravity Exposed Endothelial Cells
Study type: Observational

Summary: 
      The goal of this study is to assess the affect of ground based microgravity on co-cultured
      vascular cell types. Our goal is to better understand the cross-talk between vascular cell
      types grown under conditions such as microgravity as is seen in space. In this pilot study,
      the investigator proposes to assess changes in cell phenotype and function in microgravity as
      compared to normal gravity.
    

Detailed description: 
      This study builds upon previously reported space flight data in GenLab, as well as our own
      published data whereby the investigator evaluate the effect of microgravity on the
      differentiation and functional potential of circulating stem cells. The goal of this work is
      to leverage the powerful genetic analyses done in the SPHINX study and look at the
      consequences these changes have on cell-cell communications essential for vascular
      homeostasis, for a possible correlation to cardiovascular deconditioning. The application of
      this work is targeted at possible "cell based" countermeasures to address the negative
      effects of microgravity on the vasculature.
    

Intervention name(s): Blood volume collected specifically for this study
Intervention type(s): Biological
Intervention description(s): The subject will be sitting in a chair, and a needle will be inserted into a vein in their arm. Study Team will draw about 45ml or 3 tablespoons of whole blood for research.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The Study team is interested in sampling a wide variety of health individuals from varying
        ethnic groups, sex, and age range.
      
Biospecimen description: 
      stem cell acquisition and differentiation
    
Keywords: Cell Culture; Microgravity co-culture
Cryotherapy and Laser Therapy on Muscle Damage
Condition: Myalgia [C05.651.542]
MeSH terms: Myalgia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study propose investigate the effect of cryotherapy and laser therapy in response to
      strenuous exercise-induced muscle damage on the biceps brachii muscle (muscle of the arms).
      All the individuals underwent to an strenuous exercise protocol (2 series of 10 contractions
      of non-dominant elbow flexors) and three assessments (pre, post and 48hr after the exercise),
      composed of pain sensation, measure of the strength and muscle activation.
    


Intervention name(s): Cryotherapy; Laser therapy
Intervention type(s): Other; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cryotherapy; laser therapy; eccentric exercise; delayed onset muscle soreness; muscle damage; dynamometry; electromyography
TTA in Treatment of Diabetes and Dyslipidemia
Condition: Type 2 Diabetes Mellitus; Dyslipidemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Dyslipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to evaluate the short-term effects of tetradecylthioacetic acid (TTA)
      on plasma lipids and glucose in male patients with type 2 diabetes mellitus and dyslipidemia
    

Detailed description: 
      The tight linkage of obesity, insulin resistance (and frank diabetes), dyslipidemia, and
      hypertension has been widely observed and has been named syndrome X, or the metabolic
      syndrome. For many years metformin has been the only drug in clinical use with effects on
      insulin resistance. Recently, agonists of the peroxisome proliferator-activated receptors
      (PPARs) have been introduced in the treatment of type 2 diabetes. The different PPARs seem to
      be activated by a wide range of lipids and lipid mediators, including fatty acids.
      2-tetradecylthioacetic acid (TTA) is a modified fatty acid with high affinity for the
      PPARgamma receptor. In animal models of obesity-related insulin resistance (obese Zucker rats
      and dietary manipulated Wistar rats), TTA has an insulin sensitizing effect by enhancing the
      insulin mediated uptake of glucose in peripheral tissues. TTA treatment promotes fatty acid
      catabolism in experimental animals and this could casually be linked to the improved glucose
      tolerance.

      The protocol for the present study describes a safety assessment and therapeutic exploratory
      evaluation of TTA in a small subset of male type 2 diabetes patients for 4 weeks. The primary
      safety parameters will include general physical observational parameters, liver function test
      and hematological parameters. To goal is to assess the efficacy of TTA on selected metabolic
      parameters including fasting blood glucose and insulin, fasting plasma lipids, antioxidant
      status, and fibrinolytic parameters, weight, BMI and blood pressure.
    

Intervention name(s): Tetradecylthioacetic acid (TTA)
Intervention type(s): Drug
Intervention description(s): 1000mg capsules once daily for 28 days
Intervention MeSH terms: 1-(carboxymethylthio)tetradecane
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mapping Human Muscle Satellite Cell Fate By Real-Time Imaging
Condition: Flaccid Muscle Tone
MeSH terms: Muscle Hypotonia
Study type: Interventional

Summary: 
      Mapping Human Muscle Satellite Cell Fate By Real-Time Imaging
    

Detailed description: 
      The aim of this study is to obtain human muscle samples for cell culturing to analyze muscle
      cell development in real-time to uncover factors that influence growth.
    

Intervention name(s): muscle biopsy
Intervention type(s): Procedure
Intervention description(s): a muscle sample will be taken from the mid-thigh (Vastus Lateralis) and analyzed
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety and Efficacy of Deoxycholic Acid Injection for Reduction of Upper Inner Thigh Fat
Condition: Adiposity
MeSH terms: Obesity
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a phase I, open-label clinical trial evaluating the safety and efficacy of
      deoxycholic acid injection for reduction of upper inner thigh fat.
    

Detailed description: 
      Unwanted upper inner thigh fat is a common aesthetic complaint from patients, and current
      treatment options include liposuction and cryolipolysis (CoolSculpting, Allergan, Irvine,
      CA). Deoxycholic acid (Kybella, Allergan, Irvine, CA) is an FDA-approved injectable for the
      treatment of excess submental fat. At this time, it is not known if deoxycholic acid may be a
      safe and effective treatment for upper inner thigh fat. The proposed clinical trial will
      evaluate the safety and efficacy of deoxycholic acid for reduction of upper inner thigh fat.

      In this single-arm, open-label safety and efficacy study, 15 subjects with excess upper inner
      thigh fat will receive 1-4 treatment sessions of subcutaneously injected deoxycholic acid.
      Subjects will be followed for 12 weeks after last treatment. Adverse events will be
      monitored. Efficacy will be objectively measured by change in thigh circumference; change in
      upper inner thigh skin fold thickness; increase in "thigh gap;" and percent accuracy by three
      blinded physicians in correctly identifying baseline photographs, upon independent review of
      before-and-after clinical photographs of the treatment area. Patient satisfaction related to
      the study treatment will be assessed with a Subject Self-Rating Scale throughout the study,
      and with a Post-Treatment Satisfaction Questionnaire.
    

Intervention name(s): Deoxycholic Acid
Intervention type(s): Drug
Intervention description(s): Deoxycholic acid (Kybella) 10 mg/ mL subcutaneous
Intervention MeSH terms: Deoxycholic Acid
Intervention model: Single Group Assignment
Intervention model description: All subjects will receive deoxycholic acid (1-4 treatment sessions) for treatment of upper inner thigh fat.
Masking: None (Open Label)
Primary purpose: Treatment
Behavioral Effects of Drugs (Inpatient): 40 [Methamphetamine, Methylphenidate, Duloxetine]
Condition: Methamphetamine Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the behavioral effects of methamphetamine during maintenance on
      placebo, duloxetine, methylphenidate and duloxetine combined with methylphenidate using
      sophisticated human laboratory methods.
    


Intervention name(s): Methamphetamine; Methylphenidate; Placebo oral capsule; Duloxetine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): In each arm, subjects will receive doses of methamphetamine.; In each arm, subjects will receive methylphenidate capsules.; In each arm, subjects will receive placebo capsules.; Subjects will receive duloxetine capsules in the duloxetine arm.
Other intervention name(s): Metamfetamine; Metadate®; Lactose; Cymbalta®
Intervention MeSH terms: Duloxetine Hydrochloride; Methylphenidate; Methamphetamine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Methamphetamine; Methylphenidate; Duloxetine Hydrochloride; Central Nervous System Stimulants; Physiological Effects of Drugs; Dopamine Uptake Inhibitors; Serotonin and Noradrenaline Reuptake Inhibitors; Membrane Transport Modulators; Neurotransmitter Agents; Dopamine Agents; Molecular Mechanisms of Pharmacological Action; Sensory System Agents; Peripheral Nervous System Agents; Vasoconstrictor Agents; Antidepressive Agents; Psychotropic Drugs
Vitamin D Therapy in Patients With Systemic Lupus Erythematosus (SLE)
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test the safety and effectiveness of different doses of
      vitamin D in patients with Systemic Lupus Erythematosus (SLE). A long term goal is to
      determine if vitamin D could be used as a treatment and/or preventative of SLE.
    


Intervention name(s): Cholecalciferol; Cholecalciferol; Cholecalciferol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 800 IU oral daily; 2000 IU oral daily; 4000 IU oral daily
Other intervention name(s): Vitamin D3; Vitamin D3; Vitamin D3
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vitamin D; Lupus
Dose-Escalation Study on Safety and Immunogenicity of VPM1002 in Comparison to BCG in Healthy Volunteers in South Africa
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Goal of VPM is the development of a recombinant urease C-deficient listeriolysin expressing
      BCG vaccine strain (VPM1002) as a safe, well tolerated and efficacious vaccine against
      tuberculosis (TB) for residents in endemic areas and persons at risk in non-endemic areas.
      The new vaccine should be at least as potent as the current strain and should be safer than
      BCG (Kaufmann, 2007a; Grode et al., 2005). The vaccine is formulated as live lyophilised
      bacteria to be re-suspended before intradermal injection. The preceding clinical trial in 80
      volunteers in Germany indicated immunogenicity and safety being sufficient for proceeding
      with the clinical development. Hence, the current study is commenced in South Africa, a
      country highly endemic for tuberculosis.

      24 volunteers were randomly allocated to 4 groups each with 6 adult healthy volunteers.
    


Intervention name(s): VPM1002 live vaccine; commercially available live vaccine BCG
Intervention type(s): Biological; Biological
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Tuberculosis; Vaccine; Live Vaccine; rBCG
The Effectiveness of a Mechanical Debridement Instrument in Reducing Bioburden in Chronic Wounds
Condition: Acute Wounds; Chronic Wounds
MeSH terms: Wounds and Injuries
Study type: Observational

Summary: 
      This prospective clinical trial will compare the bacterial burden in the wound bed and on the
      periwound skin before and after mechanical debridement with EZ Debride using fluorescence
      imaging.

      After consenting, the ulcers of eligible subjects are measured, photographed and undergo the
      MolecuLight imaging procedure (MLiX). The ulcer is mechanically debridement with the EZ
      Debride device after which a second MLiX procedure is performed. The investigator will then
      compare the two images.
    

Detailed description: 
      Acute and chronic wounds burden healthcare systems across the globe. In the United States the
      cost of nonhealing wounds approximates 100 billion dollars.1-3 The presence of bacteria in
      and around the wound impedes wound healing. Clinicians treat elevated wound bacterial levels
      with mechanical and sharp debridement, topical antiseptics and systemic antibiotics. However,
      evidence on the best methods to reduce bacterial load is lacking. The EZ-1 clinical trial
      will utilize the latest fluorescence imaging technology to investigate whether mechanical
      debridement using the EZ Debride® tool reduces bacterial burden.
    

Intervention name(s): EZ Debride®
Intervention type(s): Device
Intervention description(s): EZ Debride ® is intended for the mechanical debridement of topical wounds including partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post Mohs' surgery, post-laser surgery, podiatric, wound dehiscence) trauma wounds (abrasions, lacerations, second-degree burns and skin tears), draining wounds and tunnelled /undermined wounds.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with acute or chronic wounds
The Effect of Blue-light Filtering Spectacle Lenses on Myopia Progression in Schoolchildren
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The purpose of this study is to investigate if the blue-light filtering spectacle lenses
      promote myopia progression in schoolchildren.
    

Detailed description: 
      The effect of blue light on ocular health has been studied extensively. Shorter wavelength
      such as blue light could cause damage to the retina. The damage was more evident in the
      ageing eye. Since the tablets and mobile with blue LED backlight display are widely used,
      thus blue-light filtering spectacle lenses are now available in the market. However, whether
      this kind of lenses could affect the eye growth in schoolchildren is unknown. This study is
      then designed to investigate if the blue-light filtering spectacle lenses affect myopia
      progression in Hong Kong Chinese schoolchildren. The schoolchildren will be randomly
      allocated to either blue-light filtering spectacle lens group (treated) or conventional
      spectacle lens group (control). Their axial length and refraction will be monitored every 6
      months for 2 years. The changes between two group will then be compared.
    

Intervention name(s): Blue-light filtering spectacle lenses
Intervention type(s): Device
Intervention description(s): This is a single vision spectacle lens for correction of distant refractions and filtering out the blue light by providing anti-blue light coating.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: blue light filtering spectacle lens
Effects of Targeting Lower Arterial Oxygen Saturations on the Development of Control of Breathing in Very Preterm Infants
Condition: Development of Control of Breathing
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To determine whether targeting lower arterial oxygen saturations from the day of birth alters
      the early (first 3 months) postnatal development of the control of ventilation and the
      hypercapnic and hyperoxic responses in very preterm infants.
    

Detailed description: 
      To measure the effects of baseline oxygenation in extremely low birth weight preterm infants
      on:

      i) The early (first 5 breaths) and late or steady state (3-5 minutes) ventilatory response to
      CO2 ii) The immediate (< 1 minute) ventilatory response to hyperoxia iii) The PCO2 apneic
      threshold iv) The breathing pattern during quiet and REM sleep v) The morphology of periodic
      breathing cycles vi) The incidence and morphology of sighs
    

Intervention name(s): Oxygen saturation range; Oxygen saturation range
Intervention type(s): Other; Other
Intervention description(s): Maintain functional oxygen saturation range between 91 and 95%; Maintain functional arterial oxygen saturations in the range of 85- 89%
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: hypercapneic response; hyperoxic response; breathing pattern; periodic breathing; sighs
Efficacy and Safety of Viusid in Patients With Nonalcoholic Steatohepatitis
Condition: Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate whether Viusid, a nutritional supplement, in
      combination with diet and exercise improve the histological results (steatosis,
      necro-inflammatory activity and fibrosis) in comparison with diet and exercise, during 24
      weeks of treatment.
    


Intervention name(s): Viusid; Hypocaloric Diet with controlled exercise
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Viusid, a nutritional supplement. Three oral sachets Daily 24 weeks; Modified ADA diet in combination with controlled exercise daily 24 weeks
Other intervention name(s): Nutritional supplement; lifestyle modification
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nonalcoholic steatohepatitis; Nonalcoholic Fatty Liver; Nutritional supplement; Diet; Exercise
Enhancing Memory to Facilitate Weight Loss: Tracking, Recording and Coaching
Condition: Overweight and Obesity
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      The objective of this application is to pilot test and evaluate the acceptability and
      efficacy of a program to facilitate weight loss by enhancing memory for a recently consumed
      meal.
    

Detailed description: 
      Once enrolled, all participants will receive behavioral weight loss treatment. Treatment will
      be 12 weeks in duration and will consist of 7 sessions. The content of sessions will provide
      the main elements described in behavioral therapy programs for obesity, based on empirical
      literature. Participants will be provided handouts, and the handout content will be based on
      our clinic treatment manual and published behavior therapy protocols. The program will be
      administered in individual 30-60-min sessions with a behavioral coach meeting every other
      week. This program emphasizes self-monitoring of food intake. It also emphasizes gradual
      weight loss, increasing physical activity, and improving diet through permanent lifestyle
      changes. Program topics include: self-monitoring of eating behavior, physical activity,
      changing the home environment and nutrition education. All treatment sessions will be
      conducted by licensed clinical health psychologists or psychology doctoral level students
      with experience in leading weight loss interventions.
    

Intervention name(s): Guided Self-Help Behavioral Weight Loss
Intervention type(s): Behavioral
Intervention description(s): Guided self-help Behavioral Weight Loss including 7 visits over 12 weeks. The treatment content includes self-monitoring, healthy eating, stimulus control, increasing physical activity, reducing sedentary activity, planning ahead for high-risk situations, and relapse prevention. The 7 visits are conducted with a behavioral coach to give participants educational materials and to promote accountability. The behavioral coach's role in the gshBWL program is to measure participant weight, collect self-monitoring booklets, clarify materials, and problem-solve barriers to adherence.
Other intervention name(s): gshBWL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Open Label Study to Evaluate the Effect of Kaempferia Parviflora in Support of Erectile Function and Male Sexual Health
Condition: Erectile Function
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the overall efficacy and safety of Kaempferia
      parviflora in overall healthy male human subjects.
    

Detailed description: 
      This study was an open label safety and efficacy study. Each subject received a specific dose
      of a formulation containing Kaempferia parviflora. There would be attempted telephone or
      e-mail contact in 2 weeks following enrollment.

      Participants would undergo assessments of blood tests, vital signs, body weight with
      completion of questionnaires.

      The primary objective was to assess the effect of Kaempferia parviflora on erectile function
      among overall healthy males age 50 to 70.
    

Intervention name(s): Kaempferia parviflora extract
Intervention type(s): Dietary Supplement
Other intervention name(s): KaempMax™
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Male sexual health; Erectile function
Aripiprazole Augmentation of Antidepressants in PTSD
Condition: PTSD
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      The proposed investigation will determine the therapeutic potential of aripiprazole
      augmentation to a stable antidepressant regimen for reducing posttraumatic stress disorder
      (PTSD) symptoms, cognitive symptoms, psychotic symptoms, and depressive symptoms in veterans
      with PTSD.
    


Intervention name(s): Aripiprazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Aripiprazole: 5 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-10 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-15 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-20 mg taken once a day orally for 2 weeks; Same as active drug.
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD; Antidepressant; Aripiprazole; OEF; OIF