bioihbjkbjnl/mcl2 huggingface dataset:
Pre-workout Supplement Versus Caffeine on Energy Expenditure.
Condition: Healthy
Study type: Interventional

Summary: 
      The primary purpose of this study was to examine the acute effects of a multi-ingredient
      pre-workout supplement versus an ergogenic dose of caffeine (6 mg/kg) on energy expenditure
      during low-intensity exercise. The effects of these substances on substrate utilization, gas
      exchange, and psychological factors were also investigated. Twelve males (mean ± SD: age =
      22.8 ± 2.4 years) completed three bouts of 60-min of treadmill exercise at 4.8-6.4 km/hr on
      separate days after consuming a pre-workout supplement, 6 mg/kg of caffeine, or placebo in a
      randomized fashion. The pre-workout and caffeine supplements resulted in significantly
      greater energy expenditure (p < 0.001, p = 0.006, respectively), VO2 (p < 0.001, p = 0.007,
      respectively), VCO2 (p = 0.006, p = 0.049, respectively), and VE (p < 0.001, p = 0.007,
      respectively), but not rates of fat or carbohydrate oxidation or respiratory exchange ratio
      compared to placebo (collapsed across condition). In addition, the pre-workout supplement
      increased feelings of alertness (p = 0.015) and focus (p = 0.005) 30-minutes post-ingestion
      and decreased feelings of fatigue (p = 0.014) during exercise compared to placebo (collapsed
      across condition). Thus, the pre-workout supplement increased energy expenditure and measures
      of gas exchange to the same extent as 6 mg/kg of caffeine with concomitant increased feelings
      of alertness and focus and decreased feelings of fatigue.
    


Intervention name(s): ENGN Shred; Nutricost caffeine powder; Crystal Light
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): ENGN Shred is a multi-ingredient pre-workout supplement.; Caffeine powder.; Non-caloric Crystal Light matched for the pre-workout in terms of flavor and consistency.
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: supplementation; ergogenic aid; metabolic rate; energy; substrate utilization
Pioglitazone and Lumbar Bone Marrow Fat in Chronic Kidney Disease
Condition: Polycystic Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Polycystic Kidney Diseases
Study type: Observational

Summary: 
      Chronic Kidney Disease (CKD) is associated with bone changes and very high fracture rates. A
      component of bone is marrow. Bone marrow fat is increased in patients with CKD compared to
      those in the normal population of the same age. It is not clear if there will be changes in
      the marrow fact content in those with CKD on Pioglitazone. In people with normal kidney
      function, thiazolidinedione group of drugs have had variable effects on bone marrow fat
      content, as measured by MRS. This is important as changes in marrow fat are likely related to
      changes in the bone in patients with chronic kidney disease.
    

Detailed description: 
      If patients consent to participate in the ancillary study of marrow fat changes with
      pioglitazone, those that are randomized to placebo or 15 mg pioglitazone for 12 months (per
      the criteria in the main study) will also undergo magnetic resonance spectroscopy (MRS) of
      the lumbar spine at L1, L2 and L3. MR spectroscopy of the lumbar spine (if they choose as
      this is ancillary study) will be performed 3 times over the course of the study.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): There is no intervention for this study. It is a MRS.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        PKD subjects that consent to the FDA study, number 1308084213, will be approached for
        consenting for this bone marrow fat study.

        Subject must be enrolled in NCT#02697617
Renal and Digestive Tolerance of a Food Supplement, Phytalgic, in Elderly Volunteers - A Multicentric Open Trial
Condition: Renal Tolerance; Digestive Tolerance
Study type: Interventional

Summary: 
      The aim of the study is to evaluate renal and digestive tolerance of a food supplement,
      phytalgic, on elderly volunteers.
    


Intervention name(s): Phytalgic
Intervention type(s): Dietary Supplement
Intervention description(s): Volunteers have to take three soft capsules per day, one in the morning and two in the evening.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Glomerular filtration rate (GFR); Aspartate Amino Transferase (ASAT); Alanine Amino transferase (ALAT); gamma Glutamyl transpeptidase (gamma GT); Lipase; Amylase
Compare Dose Regimens of AllerT, in Adults With Allergic Rhino-Conjunctivitis to Birch Pollen Studied in EEC
Condition: Allergic Rhino-Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to find the optimal dose of AllerT that should be used to treat
      moderate to severe allergies due to birch tree pollen.

      There are 4 treatment groups in this study; 3 treatment groups will receive AllerT at
      different doses and 1 treatment group will receive placebo.

      This study will also assess the effectiveness and safety of AllerT compared to placebo in
      relieving allergy symptoms.
    

Detailed description: 
      Primary Objective: To evaluate the dose-response trend of three doses of adjuvanted AllerT
      and of placebo in reducing symptoms of allergic rhino-conjunctivitis in subjects exposed to
      birch tree pollen in an environmental exposure chamber (EEC).

      Secondary Objectives:

        -  To evaluate three dose regimens of AllerT , versus a placebo in reducing symptoms of
           allergic rhino-conjunctivitis in subjects exposed to birch tree pollen in an EEC.

        -  To assess the safety and tolerability of a two month treatment with three dose regiments
           of AllerT (10 µg, 25 µg and 50 µg with Al(OH)3).

        -  To explore the immunological response to AllerT.
    

Intervention name(s): AllerT; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ultrafast immunotherapy; placebo control
Other intervention name(s): Continuous overlapping peptides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Foveal Cone Outer Segment Tips Line Defect in Macular Pseudohole
Condition: Macular Psudohole
Study type: Interventional

Summary: 
      Evaluation of recovery in foveal cone outer segment tips line defect and visual acuity after
      surgery for macular pseudohole
    


Intervention name(s): Vitrectomy
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Macular pseudohole; Cone outer segment tips line
Efficacy Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to assess the efficacy, safety and tolerability of a topical
      formulation of terbinafine solution applied daily in patients with toenail fungus. This trial
      will study patients with mild to moderate toenail fungus disease of the big toenail and their
      responses to two treatment durations, 24 or 48 weeks.
    


Intervention name(s): terbinafine; Placebo; terbinafine; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Terbinafine hydrochloride (HCl) 10 % nail solution for onychomycosis (NSO) once daily for 48 weeks; Vehicle (placebo) once daily for 48 weeks; Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis once daily for 24 weeks; Vehicle (placebo) once daily for 24 weeks
Other intervention name(s): Lamisil; Lamisil
Intervention MeSH terms: Terbinafine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Toenail fungus; Onychomycosis; Nail fungus; Toenail fungal infection; Tinea unguium; Dermatophytes; Foot dermatoses
The Significance of Urine UbA52 In the Diagnosis of Diabetic Nephropathy
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Observational

Summary: 
      Definite diagnosis of diabetic nephropathy is currently based on renal biopsy findings. In
      most cases, however, the diagnosis can be reliably made in patients with macroalbuminuria in
      the presence of diabetic retinopathy.Microalbuminuria is often used as a prognostic marker in
      type 1 diabetes, because approximately 50% of type 1 diabetes patients with microalbuminuria
      will eventually develop diabetic nephropathy. Conversely, microalbu- minuria is of much less
      value as a marker in DM because it has a variety of causes, including hypertension. Thus,
      additional markers are needed to identify patient groups with a high risk of developing overt
      diabetic nephropathy. The aims of this study is checking urine UbA52 levels with ELISA to
      identify its significance in the diagnosis of diabetic nephropathy.
    

Detailed description: 
      It is now well recognized that the incidence of diabetes is increasing worldwide. It is the
      leading cause of end-stage renal disease (ESRD) in Western countries. Diabetic nephropathy
      has been reported to occur in 25%-40% of people with diabetes. The appearance of
      microalbuminuria usually is regarded as incipient nephropathy, but recently, work has
      suggested that some individuals with diabetes and decreased GFR may not have an increased
      urinary AER.Identification of markers for prediction of the clinical course of diabetic
      nephropathy remains a major challenge. Previous research showed that m/z14766 protein by mass
      spectrometry, was selectively excreted in the urine of diabetic nephropathy patients, the m/z
      14766 mass peaks were identified as UbA52. We suppose that UbA52 can be regard as a simple
      and practical biomarker for diagnosis of diabetic nephropathy.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        patients with type 2 diabetic,diabetic with macro-or microalbuminuria and proteinuria due
        to nondiabetic renal disease from Hebei Medical University the Third Hospital.
      
Biospecimen description: 
      morning urine
    
Keywords: UbA52;diabetic nephropathy ;diabetic;ELISA
Correlation Between SUV on 68Ga-HBED-CC-PSMA and Gleason Score in Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Prostate cancer is the second leading cause of cancer death in North American men older than
      50 years. Prostate specific membrane antigen (PSMA) is a unique membrane bound glycoprotein,
      which is overexpressed manifold on prostate cancer cells and is well-characterized as an
      imaging biomarker of prostate cancer. Positron emission tomography / computer tomography
      (PET/CT) is a nuclear medicine procedure based on the measurement of positron emission from
      radiolabeled tracer molecules. 68Ga-HBED-CC-PSMA (DKFZ-11) (abbreviated 68Ga-PSMA) is a
      tracer for prostate cancer PET imaging. The strength of functional imaging methods is in
      distinguishing tissues according to metabolism rather than structure. Studies have shown that
      PET/CT imaging with 68Ga-PSMA can detect prostate cancer lesions with excellent contrast and
      a high detection rate even when the level of prostate specific antigen is low.

      Study Objectives:

      The objective of this study is to evaluate if the patient-wide SUVmax on 68Ga-PSMA PET/CT in
      locoregional and metastatic prostate cancer correlates with histopathologic Gleason score at
      initial biopsy. It is hypothesized that SUVmax will correlate positively with Gleason score.
      This is of interest because non-invasive risk stratification may be possible in the future.

      This will be a single-site JGH-only open label study in which one (1) 68Ga-PSMA PET/CT will
      be performed on study participants. A PET/CT scan takes 2-3 hours.
    


Intervention name(s): 68Ga-HBED-CC-PSMA (DKFZ-11) PET/CT
Intervention type(s): Drug
Intervention MeSH terms: Gallium 68 PSMA-11
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Electromyographic (EMG) and Mechanomyographic (MMG) Comparison
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Urinary Incontinence, Stress
Study type: Observational

Summary: 
      The purpose of this study is to assess the delay between the detection (by
      mechanomyography-MMG) of rectus abdominis contraction and the detection of cough in cough
      effort.
    


Intervention name(s): non invasive mechanomyographic device based on a 3 axes accelerometer
Intervention type(s): Device
Intervention description(s): This biomedical research consists specifically in the simultaneous acquisition of:
EMG and MMG Signals of rectus abdominis of the abdomen,
Respiratory flow,
An electrocardiogram (ECG).
These acquisitions will be conducted on 16 healthy volunteers according to a standardized protocol, at rest and during voluntary cough and various physical exercises often resulting in urinary leakage in the incontinent person.
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers
      
Keywords: mechanography; electromyography; effort cough
Aggression From the Perspective of Patients and Nurses
Condition: Aggression
MeSH terms: Aggression
Study type: Interventional

Summary: 
      The research, was planned in a randomized controlled design, aiming to evaluate the effect of
      the training given to nurses working in psychiatric clinics on the use of aggression and BVC
      (Broset Violence Checklist) on the nurses' perceptions of aggression and the compliance of
      the use of BVC, which they evaluated for the patients watched in the videos, with the BVC
      determined by expert opinion.

      The study was conducted in Adana Doctor Ekrem Tok Mental Health and Diseases Hospital between
      July 2021 and April 2022. A total of 97 nurses working in psychiatric clinics, 47 in the
      training group and 50 in the comparison group, participated in the study. A pre-test was
      administered to the nurses and nurses in the training group were randomized and given
      training including aggression and BVC use. After the training, a post-test was administered
      to all nurses.
    


Intervention name(s): Training including aggression and the use of BVC.
Intervention type(s): Other
Intervention description(s): After obtaining verbal consent from the nurses who met the inclusion criteria of the study before the pre-test was applied to the nurses, the nurses who volunteered to participate in the study were randomized within their own clinic using the simple randomization method. For this, after the data collection form was distributed before the pre-test, the nurses were asked to write the letter that came to them on the data collection form and not forget it. In order for nurses to be included in the training or comparison group, the letter A, written on the closed papers in the box prepared for simple randomization, represents the Education group, and the letter B represents the comparison group.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: pre- post test, training and control group, randomise controlled trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: aggression; aggression in psychiatry clinics; perception of aggression; risk level of violence
The Effect of Sildenafil and Tadalafil on Skeletal Muscle and Perceptual Fatigue
Condition: Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      This study is funded by the Moody Endowment. In this project, we will investigate the
      potential effect of skeletal muscle nitric oxide (NO) production on skeletal muscle
      anabolism, muscle strength, physical function, and body composition in older individuals.
      Further, we will determine whether augmentation of NO-mediated signaling reduces fatigue and
      fatigability.
    

Detailed description: 
      The Investigators hypothesize that upregulation of skeletal muscle NO-cGMP mediated responses
      through phosphodiesterase (PDE) inhibition by sildenafil or tadalafil causes an acute
      anabolic response of skeletal muscle protein synthesis. NO is well-known to elicit
      vasodilation through stimulation of cGMP signaling, and NO-mediated changes in muscle
      perfusion may influence both skeletal muscle anabolism and perceptual fatigue. To measure
      skeletal muscle protein synthesis, we will infuse a stable isotope tracer of phenylalanine
      and measure its incorporation into skeletal muscle proteins following a dose of sildenafil,
      tadalafil, or placebo. The Investigators will also determine whether differences exist
      between men and women in response to PDE inhibition. As skeletal muscle NO-cGMP signaling has
      been implicated in fatigue responses, we will assess the acute effect of sildenafil and
      tadalafil on fatigue. Fatigue can be manifested both as a performance deficit at a local
      level (e.g., a reduced ability of skeletal muscle to produce power or force) as well as a
      subjective experience of lacking physical or mental energy. Accordingly, we will use more
      than one means (skeletal muscle performance, fatigue questionnaires, accelerometers) to study
      fatigue. The Investigators hypothesize that sildenafil or tadalafil will acutely reduce
      exercise-associated fatigability and skeletal muscle fatigue development
    

Intervention name(s): Sildenafil; tadalafil; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 50 mg/day for 4 weeks; 10 mg/day for 4 weeks.; Placebo 1 capsule per day for four weeks.
Other intervention name(s): Viagra; Revatio; Cialis; Adcirca
Intervention MeSH terms: Sildenafil Citrate; Tadalafil
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects were assigned to one of 4 arms:
Sildenafil (50mg/day) for weeks 0-4. Placebo for weeks 5-8.
Tadalafil (10mg/day) for weeks 0-4. Placebo for weeks 5-8.
Placebo for weeks 0-4. Sildenafil (50mg/day) for weeks 5-8.
Placebo for weeks 0-4. Tadalafil (10mg/day) for weeks 5-8.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Fatigue; Fatigability; Surface Electromyography (sEMG); cyclic guanosine monophosphate (cGMP); Nitric Oxide (NO); NO-cGMP; Phosphodiesterase (PDE); Sildenafil; Tadalafil; Isotope; Infusion; Anabolism; Upregulation; Accelerometer; Placebo; Nitrosylation
COMPARISON OF OUTCOMES OF BI-FLANGED METAL STENT ALONE VERSUS BI-FLANGED METAL STENT WITH CO-AXIAL PLASTIC STENT FOR DRAINAGE OF WALLED-OFF PANCREATIC NECROSIS - A PROSPECTIVE RANDOMISED CONTROLLED STUDY.
Condition: ENDOSCOPIC ULTRASONOGRAPHY
MeSH terms: Pancreatitis, Acute Necrotizing; Necrosis
Study type: Interventional

Summary: 
      Endoscopic ultrasound guided drainage of WON with metal stent is the mainstay of WON
      management.

      But there are few complications related to BFMS , like bleeding due to vessel erosion, stent
      clogging , stent migration .

      This study is to assess, whether placing an anchoring DPS through the BFMS will decrease
      adverse events or not.

      There are only 2 retrospective studies till date ,comparing LAMS with coaxial stent vs LAMS
      alone.

      one study showed no significant decrease in adverse events , one study showed decrease in
      adverse events when DPS with LAMS .

      But there has been no prospective RCT to assess the utility of DPS to date
    

Detailed description: 
      Inclusion Criteria: -

        1. Symptomatic Walled-off pancreatic necrosis (WON)

        2. Eligible for EUS guided BFMS placement

        3. Signed informed consent .

        4. Age >18 Years

      Exclusion Criteria: -

        1. Types of pancreatic collections other than WON .

        2. Drainage with stents other than BFMS

        3. Previous attempts at drainage of WON

        4. Coagulopathy (INR>1.5) or thrombocytopenia(plc <50000/cmm)- not correctable.

        5. Pregnancy

        6. Not willing to give informed consent
    

Intervention name(s): Endoscopic ultrasound guided drainage of walled off pancreatic necrosis
Intervention type(s): Procedure
Intervention description(s): It is Therapeutic procedure to treat walled off pancreatic necrosis.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Transarterial Chemoembolization for Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Thrombosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Transcatheter arterial chemoembolization (TACE) had been proved to improve the survivals for
      middle stage hepatocellular carcinoma (HCC), but for advanced stage HCC its' efficacy had not
      been proved. The investigators hypothesize that TACE also improve the survivals for advanced
      stage HCC. Thus, the investigators carried out this prospective control study to find out if
      the survivals for patients after TACE better than only best support or not.
    


Intervention name(s): transcatheter arterial chemoembolization
Intervention type(s): Procedure
Intervention description(s): chemo-lipiodolization with EADM 50mg, Lobaplatin 50mg, and MMC 6mg,plus particleembolization.
Other intervention name(s): TACE
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatocellular carcinoma; transcatheter arterial chemoembolization; prospective control study; best support care; survival
PACAP38´s (Pituitary Adenylate Cyclase-Activating Polypeptide) Headache Inducing Characteristics and Effects on the Cerebral Blood Flow
Condition: Migraine Without Aura
MeSH terms: Migraine Disorders; Migraine without Aura; Headache
Study type: Interventional

Summary: 
      To investigate headache score and accompanying symptoms during and after infusion of PACAP38
      i migraine patients
    

Detailed description: 
      To investigate headache score and accompanying symptoms during and after infusion of PACAP38

      Changes in regional cerebral blood flow (rCBF) in the area supplied by middle cerebral artery
      (MCA), blood flow in MCA, diameter of the superficial temporal artery (STA) and radial artery
      (RA)
    

Intervention name(s): PACAP38
Intervention type(s): Drug
Intervention description(s): 10 pmol/kg/min given one time
Intervention MeSH terms: Pituitary Adenylate Cyclase-Activating Polypeptide