bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Phototherapy by Low-level Light-emitting Diode Therapy (LEDT) on Clinical, Biochemical, Biomechanical, Histologic and Genetic Responses of Muscle Performance of Young Males Submitted to Physical Strength Training
Condition: Healthy
Study type: Interventional

Summary: 
      Muscle performance is largely influenced by modulations in gene expressions of muscle tissue.
      In this context, light-emitting diode therapy (LEDT) has been used to improve muscle
      performance in experimental models and human researches. Thereby, the investigators examined
      modulations in gene expression of muscle tissue as well as biochemical, biomechanic and
      histologic adaptations influenced by exercise associated to LEDT.
    

Detailed description: 
      This study assessed muscle performance in isokinetic dynamometry and led press device, gene
      expression by RT-PCR, lactate, creatine kinase and morphology of muscle tissue by
      immunohistochemical analysis
    

Intervention name(s): Effective light-emitting diode therapy; Placebo light-emitting diode therapy
Intervention type(s): Device; Device
Other intervention name(s): LED; LED therapy; Light-emitting diode therapy; LED; LED therapy; Light-emitting diode therapy
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Light-emitting diode therapy; Muscle performance; Gene expression; Functional performance
Implications of MEDIcal Low Dose RADiation Exposure - BReast Cancer Acute Coronary Events
Condition: Breast Cancer Female; Acute Coronary Events; Cardiac Complications
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      MEDIRAD-BRACE aims to determine the relationship between 3D dose distributions in cardiac
      structures and the risk of acute coronary events (ACE) and other cardiac complications in
      breast cancer (BC) patients to develop and externally validate multivariable Normal Tissue
      Complication Probability (NTCP) models to assess the risk of ACE in individual patients based
      on cardiac dose metrics in the first 10 years after BC radiotherapy.
    


Intervention name(s): Radiotherapy
Intervention type(s): Radiation
Intervention description(s): Breast cancer patients treated with radiotherapy
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adult, female patients with stage I-III breast cancer, treated with primary surgery, either
        by mastectomy of breast conserving surgery, and postoperative RT in the period 2005-2013,
        and who were aged 40-75 years at the time of RT
      
Keywords: Breast cancer; Radiotherapy; Cardiac complications; Acute coronary events; NTCP model
Comparison of Nutritional Products for People With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Compare the glycemic and insulinemic responses of a standard nutritional product with two
      diabetes-specific nutritional products in patients with type 2 diabetes.
    


Intervention name(s): standard nutritional product (medical food); nutritional product for diabetes (medical food); diabetes specific experimental nutritional product (medical food)
Intervention type(s): Other; Other; Other
Intervention description(s): once during crossover; once during crossover; once during crossover
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Vascular Risk Factors in INPH-patients
Condition: Hydrocephalus, Normal Pressure; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases
MeSH terms: Nervous System Diseases; Hydrocephalus; Brain Diseases; Central Nervous System Diseases; Hydrocephalus, Normal Pressure; Vascular Diseases
Study type: Observational

Summary: 
      Idiopathic normal pressure hydrocephalus (INPH) is a treatable and a common disease of the
      elderly. The overall objective of this work is to describe cardio- and cerebrovascular risk
      factors and vascular disease in shunted INPH-patients compared to an age- and sex matched
      elderly population, as well as the impact of vascular risk factors and vascular co-morbidity
      on clinical symptoms and outcome of surgery in INPH-patients. The hypothesis is that
      INPH-patients have a higher level of vascular risk factors and subclinical organ damage than
      a normal elderly population, and that the higher the level of existing vascular risk factors,
      the more severe the symptoms of the hydrocephalic disease.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Cases are all INPH-patients who underwent surgery 2008-2010 and are registered in the
        Swedish National Register of Hydrocephalus. Controls were found in the Swedish population
        indox of Umeå, and were indivdually matched to cases according to age and sex.
      
Keywords: Normal pressure hydrocephalus; Vascular risk factors
Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Linagliptin Compared With the Free Combination of Empagliflozin Tablet and Linagliptin Tablet in Healthy Male and Female Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the bioequivalence of one fixed dose
      combination tablet of empagliflozin/linagliptin (Test, T) compared with the free combination
      of one empagliflozin tablet and one linagliptin tablet (Reference, R) administered as single
      dose under fasted conditions.
    


Intervention name(s): Empagliflozin; Linagliptin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Empagliflozin; Linagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of Cool Dialysate on the Sleep/Wake Cycle in Patients on Chronic Hemodialysis - "The Sleep Cool Study"
Condition: End-stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Interventional

Summary: 
      A major component of this study is to test a novel application for a safe, non-pharmacologic,
      cost-effective intervention that is already in use in clinical practice - using cool
      dialysate during hemodialysis to help stabilize the sleep/wake cycle of chronic hemodialysis
      patients. We will also evaluate its effects on selected sleep-related physiologic,
      psychological, behavioral, and general health outcomes.
    

Detailed description: 
      Preliminary results demonstrate that, after one treatment, using cool dialysate instead of
      warm dialysate markedly normalized the rhythm of body temperature and improved indices on
      nocturnal sleep quantity and quality. Therefore, a major component of this study is to test a
      novel application for a safe, non-pharmacologic, cost-effective intervention that is alreay
      in use in clinical practice - using cool dialysate during hemodialysis to help stabilize the
      sleep/wake cycle of chronic hemodialysis patients. We will also evaluate its effects on
      selected sleep-related physiologic, psychological, behavioral, and general health outcomes.

      To test the efficacy of this intervention, a randomized, single-blinded, pretest-posttest,
      control group design is being used. The major independent variable is dialysate temperature.
      The major dependent variables are measures of sleep, body temperature, rest/activity
      patterns, and general health outcomes.
    

Intervention name(s): Cool Dialysate
Intervention type(s): Procedure
Intervention description(s): Decreased temperature of the dialysis bath
Intervention MeSH terms: Dialysis Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Sleep; Renal failure; Dialysis
A Study in Healthy Men and Women to Test Which Effects Donepezil and BI 425809 Have on Each Other
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of Part 1of this trial is to investigate the effect of co-administration
      of multiple doses of donepezil on the single-dose pharmacokinetics of BI 425809 in healthy
      subjects. In Part 2 the main objective is the investigation of the effect of
      co-administration of multiple doses of BI 425809 on the single-dose pharmacokinetics of
      donepezil in healthy subjects.
    


Intervention name(s): BI 425809; Donepezil
Intervention type(s): Drug; Drug
Intervention description(s): Film coated tablet; Film coated tablet
Intervention MeSH terms: Donepezil; BI 425809
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Virtual Reality and Pain Perception During Exercises for Patients With Chronic Non-specific Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Immersion in a virtual reality environment has been shown to reduce pain during a variety of
      painful medical procedures, such as wound care for burn patients and dental care. Often,
      serious games are used to distract patients from this painful procedures. Recently, serious
      games have also been developed for patients with low back pain. Because patients with low
      back pain frequently experience pain during exercises, the investigators hypothesize that
      exercising with serious games can reduce the pain intensity and the time spent thinking of
      pain during exercises. To test this hypothesis, the investigators will conduct a randomized
      controlled trial where two groups will be compared: the experimental group will perform one
      session of exercises with serious games, while the control group will perform one session of
      the same exercises without the serious games.
    


Intervention name(s): Virtual reality exercise group; Conventional exercise group (control group)
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Chronic Low Back Pain; Virtual Reality; Serious Gaming; Exercise Therapy; Distraction
A Study to Evaluate the Effect of Roflumilast on Airway Inflammation and Function Following Allergen Challenge in Subjects With Allergic Asthma
Condition: Allergic Asthma
MeSH terms: Asthma; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      The study was a double-blind, placebo-controlled, crossover study to evaluate the efficacy of
      roflumilast on airway inflammation and function in patients with allergen-induced asthma.

      Individuals with stable, mild to moderate allergic asthma, with a history of episodic wheeze
      and shortness of breath, were eligible for enrollment.
    


Intervention name(s): Roflumilast; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Roflumilast 500 μg, one tablet once daily, orally; Placebo, one tablet once daily, orally
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Airway Inflammation; Roflumilast
Study on FOLFOX6 as First-line Therapy to Treat Recurrent or Metastatic Esophageal Cancer
Condition: Esophageal Squamous Cell Carcinoma
MeSH terms: Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to explore whether FOLFOX6 as treatment could improve the time to
      progression (TTP) and overall survival (OS) of the patient with recurrent or metastatic
      esophagus.
    

Detailed description: 
      Explore whether FOLFOX6 as treatment could improve the TTP and OS of the patient with
      recurrent or metastatic esophagus
    

Intervention name(s): FOLFOX6
Intervention type(s): Drug
Intervention description(s): OXA 100mg/m2 ivgtt 2h d1 LV 400mg/m2 ivgtt 2h d1 5FU 400mg/m2 iv. d1 5FU 2.4g/m2 civ 46h
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Metabolism and Excretion of [14C]-Rigosertib After Infusion to Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to gain an understanding of how the experimental anti-cancer
      drug, rigosertib, is metabolized in the body and excreted in the urine and feces after it is
      given as an intravenous infusion. In addition, the study will be carefully monitored to see
      if any side effects occur.

      A radioactive drug is used in this study because it is easier and more accurate to measure
      radioactivity than to use more complicated and less sensitive chemical tests for the drug.
    

Detailed description: 
      This study will be an open-label, non-randomized, metabolism and excretion study of
      [14C]-rigosertib administered as a single dose of approximately 450 mg containing 250 μCi
      [14C]-labeled rigosertib as a 24-hour continuous intravenous (CIV) infusion in healthy
      volunteers. Up to 8 subjects will be enrolled to ensure at least 6 subjects have evaluable
      data.

      Eligible subjects will be confined at the clinical site from the time of Check-in
      (approximately 24 hours prior to dosing) until Discharge (between Days 6 and 10). One single
      dose of [14C]-rigosertib will be administered as a 24-hour continuous intravenous infusion on
      Day 1. Subjects will be discharged as early as 120 hours after the start of the infusion,
      after ≥ 90% of the administered radioactive dose has been recovered in urine and feces or
      when the combined total radioactivity recovered in urine and feces is ≤ 1% of the
      administered radioactive dose for 2 consecutive 24-hr samples. The maximum stay will be until
      Day 10 (216 hours after the start of the infusion).
    

Intervention name(s): rigosertib
Intervention type(s): Drug
Intervention description(s): A single dose of 450 mg of rigosertib containing 250 microcuries of carbon 14-labeled rigosertib ([14C]-rigosertib) administered as a continuous intravenous (CIV) infusion over 24 hours to healthy volunteers.
Other intervention name(s): rigosertib sodium; ON 01910.Na
Intervention MeSH terms: ON 01910
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Association Between Vitamin D and Inflammation and Diabetes Risk in Morbidly Obese Pre-Menopausal Women
Condition: Insulin Sensitivity
MeSH terms: Insulin Resistance; Inflammation
Study type: Observational [Patient Registry]

Summary: 
      Obesity is associated with low-grade inflammation, insulin resistance and low vitamin D
      status. Vitamin D has traditionally been known to involve in calcium homeostasis and prevent
      rickets; however, recently it has been recognized to inversely associate with many
      non-skeletal diseases and conditions including obesity and type 2 diabetes (T2DM). In vitro
      studies have demonstrated that vitamin D possesses anti-inflammatory properties. It remains
      unknown if the effect of vitamin D on insulin sensitivity is mediated by suppressing
      inflammation in human adipose tissues. The main objective of this study was to assess the
      association between vitamin D and insulin sensitivity and inflammation in morbidly obese
      pre-menopausal women. Obese women (n=76) were recruited from the University of Illinois at
      Chicago (UIC) Nutrition and Wellness Center and the UIC medical center bariatric surgery
      clinics. Insulin sensitivity/resistance was assessed by (1) Oral glucose insulin sensitivity
      (OGIS) index, derived from dynamic oral glucose tolerance test (OGTT), and (2) Homeostasis
      model of insulin resistance (HOMA-IR), calculated from fasting steady-state glucose and
      insulin. Also, to better understand the potential mechanism and the role circulating vitamin
      D (25OHD) plays in adipose tissue inflammation, we assessed messenger ribonucleic acid (mRNA)
      expression of vitamin D receptor (VDR) and various inflammatory genes in visceral (VAT) and
      subcutaneous adipose tissues (SAT) of obese women that underwent a restrictive bariatric
      procedure. We hypothesized that subjects with higher serum vitamin D levels would be less
      inflamed and more insulin sensitive and have increased expression of VDR and pro-inflammatory
      markers compared to those with lower serum vitamin D levels.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Study subjects are drawn from women seeking surgical treatment for their morbid obesity at
        the University of Illinois at Chicago Medical Center (UICMC) Bariatric surgery clinics.
      
Biospecimen description: 
      Plasma Adipose tissues
    
Keywords: Vitamin D deficiency; Inflammation; Obesity
Anorectal Function in Perianal Crohn's Disease
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Observational

Summary: 
      Perianal Crohn's disease is a disabling disease associated with increased morbidity and
      impaired quality of life. It is associated with pain, discharge, fecal incontinence and
      sexual and psychological impairment. In refractory cases, a stoma may be necessary. A higher
      prevalence is seen with increasing Crohn's disease duration and appears to vary according to
      the disease location. The presence of symptoms associated with anorectal dysfunction, such as
      fecal incontinence, can sometimes poorly correlate with the presence of anal sphincter
      abnormalities. Moreover, even in patients without symptoms, the presence of anal sphincter
      abnormalities may have important implications for the future selection of type of delivery,
      and might even pose a contra-indication for certain types of anorectal surgeries.

      Studies evaluating possible chronic complications of perianal Crohn's disease on anorectal
      function are lacking. There is a need for a better understanding of the chronic complications
      of this disease, and the role of high-resolution anorectal manometry in diagnosing these
      abnormalities during follow-up of these patients. This study will evaluate the chronic
      repercussions of perianal Crohn's disease in patients with a previous anal fistula and/or
      abscess that has healed and/or is inactive.
    


Intervention name(s): Endoanal ultrasound; High-resolution anorectal manometry; Balloon expulsion test
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): For the assessment of the internal and external anal sphincter integrity. To evaluate fistulas/perianal abscess and seton placement.; rest - basal anal pressures at rest over 60 s
squeeze - anal pressure during voluntary effort; long squeeze - anal pressure during sustained voluntary effort
cough - anorectal pressure changes during cough
push - anorectal pressure changes during simulated defecation
rectoanal inhibitory reflex - reflex anal response to rectal distension
rectal sensation - assessment of rectal sensitivity to distension.; A non-latex balloon will be inserted in the rectum after applying lubricating gel. This balloon is then filled with 50ml of warm water. The patient is ask to sit on a commode and to try to expel the device in privacy, while the time is being recorded. The test ends when the patient expelled the balloon or when 3 minutes are reach.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients attending hospital with diagnosed perianal Crohn's disease.
A Study in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria
Condition: Chronic Kidney Disease; Type 2 Diabetes Mellitus
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Albuminuria; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if the study drug is safe, tolerable and active in
      reducing albuminuria in patients with Chronic Kidney Disease with Type 2 Diabetes.
    


Intervention name(s): AZD1722; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Placebo for AZD1722
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: albuminuria
Safety and Efficacy of PB-119 in Subjects With Type 2 Diabetes and Not Well-controlled by Metformin Monotherapy
Condition: Type 2 Diabetes Mellitus (T2DM)
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and
      safety of 24 once-weekly subcutaneous doses of PB-119 to subjects with type 2 diabetes
      mellitus (T2DM) not well-controlled by metformin monotherapy.
    

Detailed description: 
      This is a phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel dose
      cohort study to evaluate the efficacy and safety of PB-119 to patients with T2DM not
      well-controlled by metformin monotherapy. Patients will be assessed for eligibility over a 2
      week screening period prior to a 4-week run-in period,a 24-week double-blind treatment period
      and a 28-week open-label treatment period. The eligible patients will be randomized to PB-119
      or placebo cohort at a 1:1 ratio for the first 24-week. Patients in PB-119 group will
      subsequently be given active drug and patients in placebo group will take placebo, all
      patients in two groups will remain metformin background therapy. In the 28-week open-label
      period, all patients will be administered active drugs. After that, there will be a 4-week
      follow-up period; All randomized patients will be taken blood samples for the pharmacokinetic
      (PK) analysis.
    

Intervention name(s): GLP-1 receptor agonist; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): PB-119 is an investigational pegylated human glucagon-like peptide-1 (GLP-1) receptor agonist. The dosing regimen is 150μg once every week as subcutaneous administration. Patients in PB-119 group will be administered the active drugs for 52 weeks (24+28).; PB-119 matched placebo will be used once every week as subcutaneous administration to placebo group for 24 weeks.
Other intervention name(s): PB-119 Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment