bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Training and Detraining on Postmenopausal Breast Cancer Survivors
Condition: Breast Neoplasm Female
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The present study aimed to verify the effects of resistance exercise training and successive
      detraining on body composition, lipid profile, muscle strength, oxidative stress, and
      inflammatory markers of postmenopausal breast cancer survivors undergoing tamoxifen
      treatment.
    

Detailed description: 
      The present study aimed to verify the effects of 12 weeks of resistance exercise training and
      successive 12 weeks of detraining on body composition (Body Mass, Body Mass Index, Fat Mass,
      and Fat-Free Mass), lipid profile (Triglycerides, Total Cholesterol, LDL-Cholesterol,
      HDL-Cholesterol), muscle strength (1RM test), oxidative stress (Thiobarbituric acid reactive
      substances,Non-Protein Thiols, Catalase activity, and Superoxide Dismutase), and inflammatory
      markers (Interferon γ, Tumor Necrosis Factor α, interleukin 6 , Adiponectin, and Interleukin
      4) of postmenopausal breast cancer survivors undergoing tamoxifen treatment.
    

Intervention name(s): Resistance exercise training; Exercise detraining
Intervention type(s): Other; Other
Intervention description(s): The exercise training program will last 12 weeks, with a frequency of three sessions per week, held on Mondays, Wednesdays, and Fridays. Each session will last approximately 50 minutes. Whenever the maximum number of pre-established repetitions is successfully performed, the intensity will be increased by 5 to 10%. All sessions will be supervised by trained professionals.; The exercise detraining will last 12 weeks without exercise.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Cancer; Immune function; Inflammation; Resistance exercise; Oxidative Stress; Menopause
The Muscle Protein Synthetic Response of Algal and Fungal Protein
Condition: Muscle Metabolism
Study type: Interventional

Summary: 
      Dietary protein intake is vital for the maintenance of skeletal muscle mass and health. The
      production of animal-based proteins sources is associated with growing environmental and
      ethical challenges. As such, sustainable alternatives are needed. Algae are sustainably
      produced high-protein sources and it is predicted that algae will become one of the most
      consumed proteins in the next decades. However, the effects of algae on the stimulation of
      muscle mass growth are unknown. Therefore, we aim to assess the rate of digestion and
      absorption, and the effects on muscle growth of two types of algae (spirulina and chlorella)
      when compared to a sustainable non-animal derived fungal reference protein (mycoprotein), a
      source known to elicit a robust anabolic response.
    


Intervention name(s): Protein ingestion
Intervention type(s): Dietary Supplement
Intervention description(s): Bolus ingestion of 25g protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Amino Acids; Protein metabolism; Resistance exercise; Muscle protein synthesis
PostPlacental IUD Insertion
Condition: Contraception
Study type: Interventional

Summary: 
      The immediate post cesarean section IUD insertion is a further step towards spreading more
      compliance to females in developing countries, with rapid increase in population size
    


Intervention name(s): Copper T intrauterine device
Intervention type(s): Device
Other intervention name(s): copper T IUD
Intervention MeSH terms: Copper
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Early Detection of COVID-19 Using Breath Analysis - Feasibility Study
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      Early Detection of COVID-19 Using Breath Analysis -Feasibility Study.
    

Detailed description: 
      An interventional diagnostic prospective study study with risks and minimal constraints.
    

Intervention name(s): Breath Biopsy
Intervention type(s): Diagnostic Test
Intervention description(s): Breath Biopsy sampling using the ReCIVA® Breath Sampler
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Dose Finding Study of Contraceptive Vaginal Ring With Different Estradiol Levels in Combination With Nestorone
Condition: Suppression of Ovulation
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical trial investigates a new vaginal delivery system made of silicone rubber,
      containing Nestorone®, a 19-nor progesterone derivative and a low dose of serum estradiol
      (E2). The investigators plan to evaluate one-month data on the serum estradiol (E2) levels of
      three different contraceptive vaginal rings that contain a fixed dose of NES and escalating
      doses (75 µg/day, 100 µg/day, or 200 µg/day) of estradiol as the basis for selecting a CVR
      for a larger contraceptive efficacy trial.
    

Detailed description: 
      This dose-finding study aims to evaluate serum estradiol levels with use of contraceptive
      vaginal rings releasing Nestorone® and escalating doses of estradiol in normal cycling women.
      The primary objective is to evaluate one-month data on the serum estradiol (E2) levels of
      three different contraceptive vaginal rings containing a fixed dose of Nestorone® (NES) and
      escalating doses of estradiol as the basis for selecting a contraceptive vaginal ring (CVR)
      dose for a contraceptive efficacy trial. The secondary objectives are to evaluate the effects
      of three different estradiol doses of a NES- E2 CVR on progesterone levels, bleeding and side
      effects during one month of use and to evaluate the effects of a hormone-free internal on
      bleeding patterns. Nestorone serum levels will further be measured as an indication of
      compliance with the continuous use of the ring.
    

Intervention name(s): Nestorone®/Estradiol Contraceptive Vaginal Ring
Intervention type(s): Device
Intervention description(s): Three arms of contraceptive vaginal rings contain a fixed dose (200 mcg/day) of Nestorone® and escalating doses (75 µg/d, 100 µg/d, or 200 µg/d /day) of estradiol
Intervention MeSH terms: ST 1435; Contraceptive Agents; Estradiol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Contraceptive vaginal ring
Myopia Control With Three Lever Irradiance of PBM Therapy in Children and Adults
Condition: Myopia; Amblyopia; Refractive Error - Myopia Axial; Ametropia
MeSH terms: Amblyopia; Myopia; Refractive Errors
Study type: Interventional

Summary: 
      Photobiomodulation therapy, that is, Low-level red-light technology provides a new and
      innovative myopia control approach. This strategy enables relatively high energies of light
      to be delivered at much shorter durations of exposure to induce the myopia control effect.
      The efficacy of the low-level red-light technology has been proven in a Chinese populationb
      for the recent 3 years with evidence based papers and amazing results. However, there's not
      yet evidence to demonstrate the relationship between the dose response effect of
      photobiomodulation therapy on myopia control at the different age lever.
    

Detailed description: 
      Previous trial has demonstrated that 3-minutes per session twice a day repeated low-level
      red-light treatment at the irridiance of 2.3mW（2.0~2.5mW) controlled 87.7% of refraction
      progression and 76.8% of axial length elongation when the time of compliance to the treatment
      was 75%. Retrospective analyze other irriadance of 1.2mW, 0.6mW and 0.37mW culturally diverse
      groups will confirm and translate this technology into a solution for myopia control
      globally.
    

Intervention name(s): Airdoc device of red light for Myopia
Intervention type(s): Device
Intervention description(s): This light is Narrow-Band, Long-Wavelength Lighting with three different illumination (400lux, 800lux, 1200lux) or irridiance (1.2mW, 0.6mW, 0.37mW) respectively. And the wavelength is 650nm. It allows biocular therapy.
Other intervention name(s): low lever laser therapy; photobiomodulation therapy; low lever light therapy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Three groups are all treated with PBM therapy with follow-up but they irradiance is different while one group is as the control.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Myopia; PBM therapy; LLLT
Persistence of Immune Response After Vaccination With Influenza Vaccine
Condition: Influenza, Human; Immunisation Reaction
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      This clinical study will be performed in subjects aged 12-60 years old enrolled in
      NCT01310374 who received 2010 seasonal influenza vaccine to evaluate the persistence of the
      immune response of influenza vaccine up to 24 months after vaccination.
    

Detailed description: 
      Subjects were previously vaccinated at 12 to 60 years of age with 2010 seasonal influenza
      vaccine.The persistence phase starts 24 months after the primary vaccination and blood
      samples will be taken at 6, 12, 18 and 24 months after primary vaccination. Subjects whose
      antibody titer less than 1:40 at 6 months after primary vaccination will receive a booster
      dose of influenza vaccine.
    

Intervention name(s): seasonal influenza vaccine
Intervention type(s): Biological
Intervention description(s): subjects whose antibodies less than 1:40 6 months later after primary vaccination will receive a booster dose of seasonal influenza vaccine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: influenza vaccine; immune response; persistence
Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis
Condition: Cholangitis, Sclerosing; Liver Cirrhosis, Biliary
MeSH terms: Liver Cirrhosis; Cholangitis; Cholangitis, Sclerosing; Liver Cirrhosis, Biliary; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      OBJECTIVES: I. Assess the safety and effectiveness of budesonide in patients with primary
      sclerosing cholangitis or primary biliary cirrhosis experiencing a suboptimal response to
      ursodeoxycholic acid.

      II. Estimate the efficacy of this therapy in these patient groups as a means of evaluating
      the feasibility of a long-term randomized trial.
    

Detailed description: 
      PROTOCOL OUTLINE:

      Patients receive budesonide by mouth 3 times daily for a minimum of 6 months. If liver
      biochemistries become normal, dosage is reduced to once daily. Treatment discontinues after 1
      year.
    

Intervention name(s): budesonide
Intervention type(s): Drug
Intervention description(s): Oral budesonide, 9 mg daily was administered for 1 year
Intervention MeSH terms: Budesonide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cirrhosis; gastrointestinal disorders; primary biliary cirrhosis; primary sclerosing cholangitis; rare disease
Study to Investigate the Potential Drug-Drug Interaction Between Elafibranor and Indomethacin
Condition: Drug-drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      The enzyme responsible for the conversion of elafibranor into its active metabolite, GFT1007,
      has not been formally identified, but it is believed to have similar characteristics to an
      α,β-ketoalkene reductase previously identified in rat liver cytosol. In vitro studies in
      human liver cytosol fractions have shown that indomethacin inhibits the enzyme responsible of
      the transformation of elafibranor into GFT1007. As a result, indomethacin was included in the
      list of prohibited co-medications in all clinical trials with elafibranor, and a formal
      Drug-Drug Interaction (DDI) clinical study is being conducted to elucidate the effect of
      indomethacin on elafibranor pharmacokinetics.
    


Intervention name(s): elafibranor; CHRONO-INDOCID
Intervention type(s): Drug; Drug
Intervention description(s): Elafibranor 120mg is a coated tablet for oral administration; CHRONO-INDOCID 75mg is a capsule for bis in die (bid) oral administration
Other intervention name(s): GFT505; Indomethacin
Intervention MeSH terms: Indomethacin
Intervention model: Sequential Assignment
Intervention model description: Open-label, one sequence crossover, single-centre, single group assignment Phase 1 study in healthy male Caucasians volunteers, aged between 18-50 years old (inclusive)
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy volunteers; Elafibranor
Single Incision Laparoscopy
Condition: Appendicitis; Cholelithiasis; Malignant Hypertension
MeSH terms: Appendicitis; Cholelithiasis; Cholecystolithiasis; Gallstones; Hypertension, Malignant
Study type: Interventional

Summary: 
      Laparoscopic surgery being performed with only one small incision via the umbilicus (belly
      button).
    


Intervention name(s): single incision laparoscopic surgery
Intervention type(s): Procedure
Intervention description(s): Surgery will be performed with ine laparoscopic incision
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: appendectomy; cholecystectomy; gastric banding; adrenalectomy; Gastric lap-band placement
Short Course, Single-dose PEG 3350 for Colonoscopy Prep in Children
Condition: Colonoscopy
Study type: Interventional

Summary: 
      The investigators propose to conduct a prospective study of a widely used bowel preparation
      regimen (polyethylene glycol 3350 + a sports drink) on pediatric patients who undergo a
      colonoscopy performed by the pediatric gastroenterology service at WRAMC/WRNMMC between 1 Sep
      2010 and 31 Dec 2011. This study will involve the following: determine efficacy of the
      cleanout, assess tolerability and acceptance of the regimen, determine an appropriate
      duration to complete the regimen and assess for any electrolyte changes or side effects.
    

Detailed description: 
      Purpose: It is hoped that by determining acceptability, safety and efficacy of this widely
      used short course, single-dose bowel preparation regimen, pediatric gastroenterologist can
      have a standardized bowel preparation for colonoscopy that will be acceptable to pediatric
      patients and their parents.

      Research Design: This study is a prospective medication trial. It will utilize laboratory
      data to detect any electrolyte changes, a patient questionnaire to assess an acceptable
      duration, tolerance and side effects of the regimen. Efficacy of the cleanout will be
      assessed using a published standardized bowel preparation scale by the endoscopist at the
      completion of the colonoscopy.

      Methodology /Technical Approach (including the number of subjects to be studied.): We
      estimate that 50 patients aged 8-18 years old military dependents who are undergoing a
      colonoscopy by the Pediatric Gastroenterology service at WRAMC/WRNMMC will be enrolled in the
      study between 1 Sep 2010 and 31 Dec 2011.
    

Intervention name(s): polyethylene glycol 3350
Intervention type(s): Drug
Intervention description(s): PEG 3350 (238 grams) mixed with 1.9 L (64 oz) of Gatorade, given in 8 oz increments every 15-30 minutes until complete starting at 18:00 on day prior to colonoscopy (max time to completion 6 hours).
Other intervention name(s): Miralax
Intervention MeSH terms: Polyethylene glycol 3350
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: PEG 3350; boston bowel preparation scale; colonoscopy cleanout; bowel preparation; miralax; gatorade; cleanout efficacy; Focus of study is efficacy of PEG 3350 cleanout for improving diagnostic yield of colonoscopy.
Brain Cell Injury in Patients With A First Episode of Psychosis
Condition: Psychoses
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Observational

Summary: 
      Patients experiencing a first episode of psychosis may have brain cell damage due to a
      chemical process called oxidation. This study will compare patients with psychosis to healthy
      volunteers to determine if there are differences in their blood that reflect oxidative brain
      cell damage.
    

Detailed description: 
      Preliminary research indicated that impaired antioxidant defense and increased lipid
      peroxidation is associated with brain changes during the onset of psychosis. Oxidative cell
      injury may contribute to poor outcomes in some patients. This study will define the extent
      and nature of oxidative cell injury that is associated with psychopathology at the onset of
      psychosis.

      Participants in this study will be patients at the D. D. Eisenhower Army Medical Center who
      are experiencing a psychotic episode for the first time. Patients will be compared with 40
      healthy volunteers (control group) matched with patients for age, gender, education, ethnic
      background, and occupational status. Patients and volunteers will have blood tests to
      determine the level of oxidative cell injury. Tests will be performed at onset of psychosis,
      and after 6 and 12 weeks of neuroleptic drug treatment. Medical histories and MRI scans will
      be used to examine the relationship of the laboratory tests to the clinical presentation.
    

Observational model: Defined Population
Time perspective: Prospective
Keywords: Complementary Therapies
Development and Application-Smart Football for Movement Evaluation and Training in the Special Education Population
Condition: Intellectual Disability
MeSH terms: Intellectual Disability
Study type: Observational

Summary: 
      Children with disabilities are frequently ignored by the general population, hence the
      development of movement evaluation and training devices for use in special education settings
      are relatively overlooked. Usually the performance of these children is not stable and
      contains variations. Hence in order to get a complete picture of their sport performance,
      simply measuring movement time and distance is definitely not representative. With the rising
      attention from government regarding fitness and social participation of the disabled in
      recent years, developing a special-designed individual evaluation & training plan is of great
      importance. To achieve this goal, a device which is able to record the complete process of
      movement, and contains algorithm that can pick up the movement characteristics of children
      with disabilities is needed. The purpose of this study is to design and develop a smart
      soccer ball system for use in children with intellectual disabilities(ID), and to compare the
      performance between children with ID and the typically developed.
    


Intervention name(s): smart soccer ball
Intervention type(s): Device
Intervention description(s): smart soccer ball was used to measure participant's performance in total time and distance for completion, and acceleration
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        children with intellectual disabilities
      
Keywords: Assistive device; the disabled; special education; movement analysis; system development
The Effect of Self-Acupressure Application on Pain, Fatigue and Sleep Quality in Cancer Patients Receiving Chemotherapy
Condition: Cancer
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The aim of this study is to examine the effect of Self-Acupressure application on pain,
      fatigue and sleep quality in cancer patients receiving chemotherapy.
    

Detailed description: 
      Self-Acupressur application will improve pain, fatigue and sleep quality in cancer patients
      receiving chemotherapy.
    

Intervention name(s): Self-Acupressure
Intervention type(s): Other
Intervention description(s): Acupressure is a therapy method performed with an instrument or hand, fingertip, palm, elbow, knee, thumb relaxation and wrist bands on various points representing the waist organs in order to ensure the continuation and balance of the energy in our body.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is an experimental study with pre-test and post-test control groups
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Self-Acupressur; Cancer patients; Pain; Fatigue; Sleep quality
Food Allergy Challenge Diagnostic Study
Condition: Food Hypersensitivity
MeSH terms: Hypersensitivity; Food Hypersensitivity
Study type: Observational

Summary: 
      The objective of this study is to correlate various diagnostic measurements taken during an
      escalating dose oral food challenge to the subject's response. This study will investigate
      whether non invasive objective biomarkers can indicate a positive response to an escalating
      dose OFC before a systemic reaction occurs.
    

Detailed description: 
      Patients often discover their food allergies after consuming a given food and experiencing a
      subsequent allergic reaction. The majority of patients (75%) will then consult a food
      allergist for formal diagnosis and treatment information. With respect to patient quality of
      life, there is tremendous benefit in having a confirmed diagnosis of food allergy as often
      patients are unsure of the source of their reaction outside the office. Allergists will
      conduct a Skin Prick Test (SPT) and assess serum specific IgE levels to screen for specific
      food protein sensitivities. However, a positive response in SPT and specific IgE will confirm
      only sensitivity, and in more than 70% of cases patients that respond positively to SPT and
      specific IgE testing will NOT manifest an allergic response to food consumption. To address
      this issue, most food allergists will recommend an oral food challenge in a controlled
      setting to confirm the allergic response from consuming the suspected foods. The oral food
      challenge (OFC) consists of consuming escalating levels of the suspect food, (usually mixed
      in applesauce or controlled baked goods), until either a reaction manifests or until the
      challenge is complete with no reaction. The food challenge process poses significant risk to
      the patient. In 5% of cases, the patient experiences a severe allergic response which
      requires the use of epinephrine. These responses typically consist of severe reactions in GI
      or respiratory and arise from challenging patients with higher doses of food allergen then is
      necessary to prove a mild allergic response, which is directly linked to variability in
      diagnosis of a positive response, within subjects and within investigators.

      The investigators hypothesize that measurements taken using minimally-invasive diagnostic
      tests during the course of an escalating-dose oral food challenge will be able to detect a
      positive response before a systemic reaction occurs in the patient and may be able to screen
      with individuals predisposed to EOE.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects with suspected food allergy and scheduled upcoming oral food challenge will be
        recruited.
      
Keywords: Food Hypersensitivity; Oral Food Challenge; Skin Prick Test; Food Biomarkers