bioihbjkbjnl/mcl2 huggingface dataset:
Comparing the Effects of Upper and Lower Body Resistance Training on Pain Sensitivity
Condition: Healthy
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      Resistance exercise may immediately lessen the perception of pain. The purpose of this study
      is compare the effects of an upper body exercise to a lower body exercise on the perception
      of pain (pressure pain threshold).
    


Intervention name(s): Lower Body Resistance Exercise; Upper Body Resistance Exercise
Intervention type(s): Other; Other
Intervention description(s): Participants will complete a leg extension exercise with weight equivalent to 75% of their estimated 1-repetition maximum 3 sets, 10 repetitions.; Participants will complete a leg extension exercise with weight equivalent to 75% of their estimated 1-repetition maximum 3 sets, 10 repetitions.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of 68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2 PET/CT in Patients With Various Types of Cancer
Condition: Tumor, Solid, FAPI, PET/CT, Metastasis
MeSH terms: Neoplasm Metastasis
Study type: Interventional

Summary: 
      To evaluate the potential usefulness of 68Ga-DOTA-2P(FAPI)2 positron emission
      tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions
      in various types of cancer, compared with 68Ga-DOTA-FAPI-46 PET/CT.
    

Detailed description: 
      In order to enhance the tumor uptake and tumor retention time, we designed the dimer
      structure of fibroblast activation protein inhibitor (FAPI), a novel imaging agent that
      targeting cancer-associated fibroblasts expressed in various types of cancer,
      68Ga-DOTA-2P(FAPI)2. Subjects with various types of cancer underwent contemporaneous
      68Ga-DOTA-2P(FAPI)2 and 68Ga-DOTA-FAPI-46 PET/CT either for an initial assessment or for
      recurrence detection. Tumor uptake was quantified by the maximum standard uptake value
      (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive
      value (NPV) and accuracy of 68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2 PET/CT were calculated
      and compared to evaluate the diagnostic efficacy.
    

Intervention name(s): 68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2 PET/CT
Intervention type(s): Diagnostic Test
Intervention description(s): Each subject receive a single intravenous injection of 68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2, and undergo PET/CT imaging within the specified time.
Intervention MeSH terms: FAPI-46
Intervention model: Single Group Assignment
Intervention model description: Subjects with various types of cancer undergo contemporaneous 68Ga-DOTA-2P(FAPI)2 and 68Ga-DOTA-FAPI-46 PET/CT either for an initial assessment or for recurrence detection.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Diagnosis, Tumor, Solid, FAPI, PET/CT, Metastasis
Autologous Transplantation of Cultured Fibroblast on Amniotic Membrane in Patients With Epidermolysis Bullosa
Condition: Epidermolysis Bullosa With Mitten Hands
MeSH terms: Epidermolysis Bullosa
Study type: Interventional
Phase: Phase 1

Summary: 
      Epidermolysis Bullosa (EB) is a blistering disease that is caused by defective anchoring
      fibrils and hemidesmosome in basement membrane of the skin layer. EB is inherited either
      autosomal or recessive and has 3 types. Recessive Dystrophic Epidermolysis Bullosa (RDEB) is
      severe with some morbidity such as mitten hand deformity.

      The management of these patients is very difficult because no effective treatment has been
      known yet.

      The EB patients with mitten hand deformity need surgery to have a biologic dressing for areas
      of hand which is without the skin. In this study the investigators assess the safety of
      autologous transplantation of cultured fibroblast on amniotic membrane (AM,as coverage) for
      them.
    

Detailed description: 
      Epidermolysis Bullosa patients with mitten hand deformity were included. (based on inclusion
      & exclusion criteria) These patients should be offered for surgery to release the adhesions
      between fingers and MCP. When the consent form was accepted and the lab test was confirmed, a
      small skin biopsy was removed from retro auricle and fibroblast cells were separated and
      cultured. These cells were seeded on AM and the microbial test was done as evidence to prove
      the safety.

      Under general anesthesia, when the hands adhesion was removed, the autologous fibroblast
      cultured on AM was transplanted to the both hands (specially the area without skin coverage)
      and the hands were dressed afterward.

      The dressing was changed and the wound was checked regularly to detect any complications.
    

Intervention name(s): Cell transplantation
Intervention type(s): Biological
Intervention description(s): autologous transplantation of cultured fibroblast on amniotic membrane in patients with Epidermolysis Bullosa with mitten hands.
Other intervention name(s): autologous transplantation of cultured fibroblast on amniotic membrane
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epidermolysis Bullosa mitten hand deformity autologous cultured fibroblast; amniotic membrane
Kinematic Analysis: Posterior Stabilized, Fixed Bearing Total Knee Arthroplasty With Attune Knee System - Phase 2
Condition: Total Knee Arthroplasty; Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Observational

Summary: 
      A better understanding of knee joint kinematics is important to explain the premature
      polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a
      prosthesis that most closely approximates the normal knee. Specifically, posterior
      stabilizing (PS) knees have been found to be associated with lower amounts of posterior
      femoral rollback, higher occurrence of reverse axial rotation and increased amount of
      condylar lift-off. The DePuy Synthes Joint Reconstruction's Attune PS fixed bearing (FB) knee
      system has incorporated subtle changes in its design to address restoration of kinematics
      that more closely resemble those of a normal knee. To understand if this design is able to
      effectively restore kinematics in the implanted knee, further in vivo analysis is necessary.
      This continuation of the study will analyze 30 subjects with the Attune PS FB 3 months
      post-operatively using the University of Tennessee's mobile fluoroscopy unit while performing
      three daily activities, level walking, ramp down and deep knee bend.
    


Intervention name(s): DePuy Attune posterior stabilizing fixed bearing knee system
Intervention type(s): Device
Intervention description(s): Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system at least three months post-operative.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system
        at least three months post-operative.
Vitamin D Supplementation for Bipolar Depression
Condition: Bipolar Disorder; Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to whether vitamin d supplementation in those with low levels
      may reduce depression symptoms in people experiencing bipolar depression.
    


Intervention name(s): Vitamin D3, Cholecalciferol; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study Comparing Tretinoin Gel Microsphere, 0.1% and RETIN-A MICRO ® Gel Microsphere, 0.1% in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To demonstrate the therapeutic equivalence and safety of Tretinoin Gel Microsphere, 0.1%
      (Taro Pharmaceuticals U.S.A, Inc.) and RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1%
      (Valeant) in the treatment of acne vulgaris.
    

Detailed description: 
      A multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing
      Tretinoin Gel Microsphere, 0.1% (Taro Pharmaceuticals U.S.A, Inc.) and RETIN-A MICRO®
      (Tretinoin) Gel Microsphere, 0.1% (Valeant) in the treatment of acne vulgaris.
    

Intervention name(s): Tretinoin Gel Microsphere, 0.1%; RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1%; Placebo Control
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The study medication will be self-applied topically, on the affected areas of the face lightly, once daily in the evening, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.; The study medication will be self-applied topically, on the affected areas of the face lightly, once daily in the evening, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.; The study medication will be self-applied topically, on the affected areas of the face lightly, once daily in the evening, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.
Other intervention name(s): Test Product; Reference Product; Vehicle
Intervention MeSH terms: Tretinoin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
A Study of OPC-41061 in Subjects With Cardiac-induced Edema (Congestive Heart Failure)
Condition: Cardiac Edema
MeSH terms: Heart Failure; Edema, Cardiac; Edema
Study type: Interventional
Phase: Phase 3

Summary: 
      To investigate the plasma drug level, efficacy, and safety of 7-day repeated oral
      administration of OPC-41061 at 15 mg/day (treatment period 1) and subsequent 7-day repeated
      administration of OPC-41061 at 15 mg/day or 30 mg/day if diuretic effect is insufficient
      (treatment period 2) in congestive heart failure (CHF) patients with extracellular volume
      expansion despite conventional diuretic therapy.
    


Intervention name(s): OPC-41061 （Tolvaptan)
Intervention type(s): Drug
Intervention description(s): 15-30mg/day,daily for 14days
Intervention MeSH terms: Tolvaptan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vasopressin antagonist , Cardiac Edema ,Diuretics
Local Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: A Multicenter Randomized, Controlled Trial (VANCO)
Condition: Post Operative Surgical Site Infection
MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection
Study type: Interventional
Phase: Phase 3

Summary: 
      The Vancomycin Study is a multi-center, prospective randomized controlled trial that will
      compare the proportion of deep surgical site infections within 6 months in patients treated
      with local Vancomycin powder compared to those treated without local Vancomycin powder at the
      time of fracture fixation.
    

Detailed description: 
      Primary Aim: Compare the proportion of deep surgical site infections within 6 months in
      patients treated with local Vancomycin powder compared to those treated without local
      Vancomycin powder.

      Primary Hypothesis: The proportion of deep surgical site infections will be lower for
      patients treated with local Vancomycin powder.

      Secondary Aim #1: Compare antibiotic sensitivities of the bacteria in the patients who
      develop deep surgical site infections in study patients treated with local Vancomycin powder
      compared to those treated without local Vancomycin powder.

      Hypothesis 1: In the patients who develop infections, the antibiotic sensitivity profiles
      between patients treated with local Vancomycin powder will be non-inferior to those treated
      without local Vancomycin powder.

      Secondary Aim #2: Build and validate a risk prediction model for the development of deep
      surgical site infections in patients treated without local Vancomycin powder. (b) Explore
      whether the effect of local Vancomycin powder is modified by the predicted risk of infection.

      Hypothesis 2: Patient (e.g. medical co-morbidities) and injury (e.g open fractures) factors
      will be highly predictive of infection risk.

      Hypothesis 3: Patients with higher predictive risk will experience greater benefit from local
      antibiotics.
    

Intervention name(s): Vancomycin antibiotic powder
Intervention type(s): Drug
Intervention description(s): At the time of fracture fixation 1000 mg of Vancomycin powder placed into the wound during wound closure.
Intervention MeSH terms: Anti-Bacterial Agents; Vancomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Surgical site infection risk prevention; Bacterial species type and antibacterial sensitives
Study to Evaluate the Effects of TRV120027 in Patients With Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In this study, TRV120027 (or a placebo) intravenous infusion will be given to people with
      heart failure to learn about the effects of TRV120027. The results of this study will help
      choose the proper range of TRV120027 doses to use in future research studies involving
      patients with acute decompensated heart failure.
    


Intervention name(s): TRV120027; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dose range (starting at 0.1 mcg/kg/min) of TRV120027 administered for 14 hours.; Placebo administered for 14 hours.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Executive Training and Brain in Adolescent
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the cognitive and brain effects of inhibitory
      control (IC) training at adolescence.
    

Detailed description: 
      Brain imaging now allows to study non-invasively cognitive learning processes. An area of
      strong scientific interest is the development of executive control, an essential cognitive
      domain for academic and professional success and for mental and physical health. These
      functions are essentially located within the prefrontal cortex, characterising by a late
      maturation until the end of adolescence and, while under genetic control, can likely be
      improved with targeted interventions. The objective of this project is simple and innovative:
      testing in adolescents with the most appropriate brain imaging technologies available today
      (the Magnetic Resonance Imaging, MRI), the effect of an executive training focused on the
      inhibitory control (IC). This project aims at precisely testing the effect at the cognitive
      and brain levels of IC training in adolescence. To do this, the investigators will recruit
      two groups of 30 teenagers aged 16 to 17 years old, each assigned to one of two learning
      situations: IC vs Active Control (AC). Each participant will participate in 25 training
      sessions of 15 minutes per day, 5 days a week for a month. Brain structural and functional
      differences in the brain and between the pre-test and post-test related to intense IC
      training will be correlated with cognitive progress.
    

Intervention name(s): Training; Training
Intervention type(s): Other; Other
Intervention description(s): 25 training sessions of 15 minutes per day, 5 days a week for a month of crystallised intelligence; 25 training sessions of 15 minutes per day, 5 days a week for a month of inhibitory control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: brain/cognitive measures; condition; inhibitor control; training at adolescence
Comparison of Pure Epicatechin and Cocoa on Markers of Vascular Function
Condition: Endothelial Dysfunction; Bioavailability
Study type: Interventional

Summary: 
      Intervention studies support a protective effect of flavonoid-rich foods such as chocolate
      and tea on cardiovascular disease risk. In a previous study we found that pure epicatechin
      improves markers of vascular function and insulin resistance although the results were less
      pronounced than the majority of chocolate intervention studies.

      The food matrix of chocolate or other compounds present in chocolate could play a role in the
      bioavailability of flavonoids, resulting in these heightened improvements in vascular
      function.

      In this study we aim to compare the acute effects of pure epicatechin and high-flavonoid
      chocolate on markers of vascular function.
    

Detailed description: 
      Twenty male participants between the ages of 40 and 80 will visit the university on three
      days, separated by a 2-week washout. During each visit the participants will, in random
      order, be allocated to one of the three interventions:

        1. High flavan-3-ol chocolate (70g) plus placebo capsule;

        2. White chocolate (70g) plus 100mg of epicatechin in capsule form;

        3. White chocolate (70g) plus placebo capsule; Measurements of vascular function will be
           taken before, and 2 hours after consumption of the supplements. In order to determine
           flavonoid bioavailability, 24-hour urine samples will be collected and 7 blood samples
           will be taken over a period of 8 hours.

      The primary study parameter is the percentage change in Flow-Mediated Dilation (FMD) as a
      result of a high-flavonoid cocoa or epicatechin challenge. Additional study parameters
      include plasma flavonoid and nitric oxide concentrations as well as pulse wave analysis
      parameters.
    

Intervention name(s): Pure Epicatechin; High flavan-3-ol cocoa; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Participants will consume 100mg of epicatechin (capsule) + 70g white chocolate; Participants will consume 70g high flavan-3-ol cocoa (100mg epicatechin) + placebo capsule; Participants will consume 70g white chocolate + placebo capsules
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Flavan-3-ol; Flavonoids; Epicatechin; Cocoa; Chocolate; Endothelial function; Bioavailability
Next Generation Probiotics (NGPs) for Metabolic Health
Condition: Microbial Colonization
MeSH terms: Communicable Diseases; Infections
Study type: Observational

Summary: 
      To identify differences in the intestinal microbiota by metagenomics analyses between lean
      and obese subjects
    


Intervention name(s): observational
Intervention type(s): Other
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        General adult population
      
Biospecimen description: 
      Fecal, urine, blood
Knemometry Study to Compare the Systemic Safety of Flutiform pMDI, Fluticasone pMDI and Beclometasone Autohaler in Paediatric Subjects Aged 5 to Less Than 12 Years.
Condition: Mild Persistent Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Aim of the study is to investigate the short-term growth in children with asthma aged 5-11
      years in treatment with fluticasone propionate / formoterol spray (flutiform®) 200/20
      micrograms per day
    


Intervention name(s): Flutiform 50/5 ug (2 puffs bid) pMDI; Fluticasone 50 ug (2puffs bid) pMDI; Beclometasone Autohaler 50 ug (2 puffs bid)
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Fluticasone; Beclomethasone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knemometry
An Interactive School Sleep Education Program
Condition: Sleep
Study type: Interventional

Summary: 
      The aim of this study is to improve sleep behavior in secondary school students, through the
      use of an educational program specifically designed for this purpose. Data will be collected
      on students' time use, sleep habits, daytime functioning and mood before and after the
      program to assess if the program is effective in improving students' sleep behavior and
      corresponding outcomes.
    

Detailed description: 
      The present study aims to examine the effectiveness of a class-based interactive Sleep
      Education Program in improving sleep behavior of secondary school students. The Sleep
      Education Program is designed by sleep experts from our laboratory, and is aimed at educating
      students about the importance of sleep and good sleep habits, as well as addressing their
      attitudes towards sleep, in order to encourage behavior change. Participants will be randomly
      assigned to the Sleep Education Program or a Control Program. All participants will undergo
      four weekly class-based lessons, which use video presentations, in-class activities,
      discussions and take-home assignments to deliver the materials. Each lesson has set goals to
      achieve. Participants in the Sleep Education Program will learn about the importance of
      sleep, what factors may prevent them from getting enough sleep, how they can manage their
      time to create more opportunity for sleep, and how they can overcome obstacles to time
      management. Emphasis will be placed on how sleep affects each student personally, and how
      each person can benefit from improving sleep. Participants in the Control Program will
      undergo a similarly structured class-based program, during which they will learn about
      various general health-related topics. However, the Control Program is designed in such a way
      that it does not cover any topics related to sleep. Data will be collected from participants
      from both groups. The following variables are measured: sleep habits, sleep knowledge,
      daytime functioning, mood and app-tracked time use. Data on all measurements will be
      collected at three time points: pre-program, immediately post-program and during a 1-month
      follow-up. Results will be compared between the three time points, as well as between the two
      groups (Sleep Education Program and Control Program). By comparing results from the Sleep
      Education Program to the Control Program, we can evaluate the effect of educating students
      about sleep on improving sleep behavior.
    

Intervention name(s): Sleep Education
Intervention type(s): Behavioral
Intervention description(s): Assessing the effectiveness of a Sleep Education Program in improving sleep behaviors in secondary school students.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science