bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Varying the Protein and Dietary Fiber Content of Energy Bars on Their Glycemic and Insulinemic Impact
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study was to determine the effect of changing the amounts of resistant
      starch, whey protein and sugar on the blood glucose and insulin responses elicited by energy
      bars. The investigators also compared the glucose and insulin responses to the rates at which
      the food bars were digested in-vitro (in the test tube). The investigators thought increasing
      resistant starch and reducing sugar would reduce the glucose and insulin responses, and that
      adding protein would reduce glucose and increase insulin. The investigators also thought the
      glucose and insulin responses in people would be related to the rate of digestion of the food
      bars in-vitro.
    


Intervention name(s): Control 1; Control 2; 15/0; 15/0LS; 15/5; 10/5; 10/10
Intervention type(s): Other; Other; Other; Other; Other; Other; Other
Intervention description(s): 67g of control bar; 86g of control bar; 66g of experimental bar 15/0; 84g of experimental bar 15/0LS; 75g of experimental bar 15/5; 72g of experimental bar 10/5; 80g of experimental bar 10/10
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Keywords: Blood glucose; Blood insulin; Humans; Postprandial; Carbohydrate; Protein; Resistant starch; Sugar
interACTION: A Portable Joint Function Monitoring and Training System for Remote Rehabilitation Following TKA
Condition: Total Knee Arthroplasty
Study type: Interventional

Summary: 
      The purpose of this study is to determine if home-based therapy with monitoring via
      telemedicine can overcome many barriers to compliance and improve rehabilitation. Patients
      undergoing total knee arthroplasty will be followed for 10 weeks during their outpatient
      physical therapy course. Subjects will undergo standard physical therapy or physical therapy
      paired with InterACTION for 10 weeks.
    


Intervention name(s): InterACTION; Standard of Care Physical Therapy
Intervention type(s): Device; Other
Intervention description(s): InterACTION guided home exercise program paired with standard of care physical therapy; Physical therapy rehabilitation program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
LMA Protector Cuff Pilot vs LMA Supreme Among Anaesthetised, Non-Paralysed Patients
Condition: Anesthesia
Study type: Interventional

Summary: 
      Comparison of clinical performance between LMA Protector Cuff Pilot and LMA Supreme in terms
      of oropharyngeal leak pressure, time to insertion, ease of gastric tube insertion, laryngeal
      view, incidence of sore throat
    


Intervention name(s): LMA Protector Cuff Pilot; LMA Supreme
Intervention type(s): Device; Device
Intervention description(s): Assessing the clinical performance of LMA Protector Cuff Pilot; Assessing the clinical performance of LMA Supreme
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: LMA Protector Cuff Pilot; LMA Supreme; Clinical Performance
The Effect of Eyelid Surgery on Dry Eye - a Prospective Study
Condition: Dry Eye Syndrome; Ptosis; Dermatochalasis
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Cutis Laxa; Syndrome
Study type: Observational

Summary: 
      The investigators aim to assess the effect of blepharoplasty with or without muller muscle
      resection on the symptoms of dry eye syndrome. this will be an observational study in which
      patients undergoing the aforementioned surgeries will be followed up and monitored for dry
      eye symptoms.
    

Detailed description: 
      Patients who are referred for blepharoplasty with or without muller muscle resection in the
      oculoplastic clinic in the investigators institution, will be offered to participate in the
      study. After filling and informed consent form, patients recruited will fill in a
      questionnaire about dry eye symptoms, and will be examined by an ophthalmologist for visual
      acuity, intra ocular pressure, anterior segment examination using a slit lamp biomicroscopy,
      schirmer test, tear break up time assessment and tear osmolarity. These are all standard
      examination in ophthalmology. The surgical procedure planned to correct the eyelid pathology
      will not be affected by the results of these examinations.

      The same combination of ophthalmic examination will by done on postoperative follow-up
      examination 1 week, 1 month and 3 months after the surgery. Dry eye questionnaire will be
      filled in by the patients on postoperative follow-up examination 1 month and 3 months after
      the surgery.

      This data will help us assess the effect of these common surgical procedures on dry eye
      symptoms.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who are referred for blepharoplasty with or without muller muscle resection in the
        oculoplastic clinic in our institution
      
Keywords: Dry eye syndrome; Blepharoplasty; Muller muscle resection surgery
Prokinetic Effect of Selected Nutraceuticals
Condition: Pulmonary Tuberculosis; Gastro-Intestinal Disorder
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional

Summary: 
      Anti-Tuberculosis Treatment (ATT) is one of the effective treatments of tuberculosis but the
      use of drugs for a long time put an adverse effect on the gut and other organs of the body.
      Nutraceuticals are the cheapest natural sources with therapeutic effects. These natural
      medicines help in alleviating gastrointestinal disturbances. This study will be conducted to
      overcome gastrointestinal issues with the help of nutraceuticals, which are more acceptable
      by the majority and have no side effects.
    

Detailed description: 
      The aim of this study will be to evaluate if Zingiber officinale, Carum carvi, L, and Mentha
      spicata L nutraceuticals can help in alleviating gastrointestinal disturbances in subjects
      which are more acceptable by the majority and have no side effects.

      This Randomized Control interventional three arms Trial will comprise three phases. Patients
      will be randomized to Zingiber officinale, Carum carvi, L, and Mentha spicata L
      nutraceuticals or placebo for three months. We will evaluate symptoms assessment, dietary
      assessment, biochemical and physical analysis i.e. Acid-Fast Bacillus (AFB) for sputum, Chest
      X-ray (CXR), and Complete Blood Count (CBC) at baseline and after 3 months since the study
      started.
    

Intervention name(s): Placebo; Zingier officinale powder; Carum carvi, L powder; Mentha spicata oil
Intervention type(s): Other; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Inert Material; The raw form of Zingiber officinale will be grounded in powder by manual grinding and will be encapsulated.; The raw form of Carum carvi, L will be grounded in powder by manual grinding and will be encapsulated.; Mentha spicata L will be extracted in the form of oil and will be encapsulated.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Phase1 - 200 population size will be divided into 4 treatment groups
Phase2
The phase will check the impact of selected nutraceuticals on TB patients with dietary counseling and all collected data in Phase1 will be repeated at the end
3 selected nutraceuticals Zingiber officinale, Carum carvi, and Mentha spicata will be used against placebo and each placed in a separate group with 50 subjects for 3 months
Before dispensing treatments, raw material will be processed and encapsulated in prescribed doses in 4 groups after breakfast and dinner T1-Placebo 100mg/d, T2-Zingiber Officinale powder (500mg 2x/d=1000mg/d), T3-Carum powder(1g 2x/d=2g/d), T4-Mentha oil(2% of oil1.5ml 2x/d=30mg/d)
Phase3
- The impact of withholding the intervention will be studied to observe any change in selected parameters
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Capsule Endoscopy With PillCam® COLON 2 in Visualization of the Colon
Condition: CRC Screening
Study type: Interventional

Summary: 
      This study was design to establish the effectiveness of PillCam® Platform with the PillCam®
      COLON 2 capsule as demonstrated by the identification of subjects with polyps as compared to
      optical colonoscopy.
    

Detailed description: 
      This multi-center study was designed to evaluate the safety and effectiveness of PillCam
      Platform with the PillCam COLON 2 capsule as demonstrated by the identification of subjects
      with polyps, compared to optical colonoscopy.

      884 subjects participated in this study. All subjects that were enrolled in this study were
      indicated and scheduled to undergo colonoscopy based on their age and demographics for
      screening for polyps.

      Each subject was required to follow a bowel preparation regimen and to undergo capsule
      endoscopy (CE) followed by optical colonoscopy (OC). The optical colonoscopy procedure was
      scheduled 4-6 weeks after CE procedure to allow for the central readers reading of the
      PillCam RAPID video.

      The colonoscopist was kept blinded to the CE results
    

Intervention name(s): PillCam® COLON 2 procedure; Colonoscopy
Intervention type(s): Device; Procedure
Intervention description(s): Subjects will undergo a PillCam® COLON 2 procedure which includes ingestion of the PillCam® COLON 2 capsule. PillCam® COLON 2 is a disposable, ingestible capsule that takes video images throughout the digestive system.; Subjects will undergo standard Colonoscopy procedure 4-6 weeks after PillCam® COLON 2 procedure.
Standard colonoscopy involves placement of a standard endoscope (a thin, flexible plastic tube) into the anus and into the colon, a tiny camera in the endoscope allows the study doctor to see the surface of the colon.
Intervention model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Screening
Keywords: Polyps; Capsule endoscopy; Colonoscopy
18616 - Sun Protection Factor Assay
Condition: Sunscreening Agent
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): Coppertone (BAY 987517)
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.(Formulation Number - X71-144)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of PEEP on Arterial Oxygen Partial Pressure in Elderly Patients With Lithotomy Position Using LMA Supreme™
Condition: Urinary Bladder Neoplasms; Prostatic Neoplasms
MeSH terms: Neoplasms; Prostatic Neoplasms; Urinary Bladder Neoplasms
Study type: Interventional

Summary: 
      The purpose of the present study is to compare the effect of PEEP on arterial oxygen partial
      pressure in elderly patients undergoing urologic surgery using LMA supreme™ in a lithotomy
      position.
    

Detailed description: 
      Positive end-expiratory pressure (PEEP) during general anesthesia with mechanical ventilation
      is routinely used as a standard lung protective strategy to prevent postoperative pulmonary
      complications including atelectasis.

      In urologic surgery, elderly patients are common. Since aging decreases the elasticity of
      lung tissues and allowing the collapse of small airways, old age is a risk factor for
      postoperative atelectasis. Lithotomy position is the preferred position in urologic surgery.
      However, it causes the abdominal viscera to displace the diaphragm cephalad, reducing lung
      compliance and resulting atelectasis. Therefore, in elderly patients undergoing urologic
      surgery with lithotomy position, PEEP may be essential to prevent postoperative atelectasis.

      Laryngeal mask airway (LMA) has been widely used in urologic surgery with lithotomy position
      because of short surgical time and no necessity of administration of muscle relaxant.
      However, application of PEEP when using LMA is still controversy. Therefore, in the present
      study, we aimed to compare the effect of PEEP on arterial oxygen partial pressure in elderly
      patients undergoing urologic surgery using LMA supreme™ in a lithotomy position.
    

Intervention name(s): PEEP
Intervention type(s): Other
Intervention description(s): After LMA Supreme™ insertion, it's proper position is confirmed. Then, PEEP of 7 cmH2O is applied during mechanical ventilation.
Other intervention name(s): Application of PEEP 7 cmH2O
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: elderly; lithotomy position; PEEP; laryngeal mask airway
A Study Of The Efficacy Of Atorvastatin For Lowering Cholesterol In High-Risk Patients With High Cholesterol
Condition: Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to evaluate the effectiveness of atorvastatin in lowering
      cholesterol and getting these high risk patients to their goals of LDL <115 mg/dl across
      starting doses of 10 mg, 20 mg, or 40 mg with one step titration.
    


Intervention name(s): Atorvastatin; Atorvastatin
Intervention type(s): Drug; Drug
Intervention description(s): In previously treated patients, starting atorvastatin doses (oral tablets given once daily) of 20 mg (in patients with LDL-C levels between 115 and 164 mg/dL at baseline) or 40 mg (in patients with LDL-C levels between 165 and 235 mg/dL at baseline) were given for 6 weeks. If LDL-C target was achieved at Week 6, doses remained the same. If LDL-C target was not achieved at Week 6, doses were doubled.; In statin-naive patients, starting atorvastatin doses (oral tablets given once daily) of 10 mg (in patients with LDL-C levels between 115 and 164 mg/dL at baseline), 20 mg (in patients with LDL-C levels between 165 and 174 mg/dL at baseline), or 40 mg (in patients with LDL-C levels between 175 and 235 mg/dL at baseline) were given for 6 weeks. If LDL-C target was achieved at Week 6, doses remained the same. If LDL-C target was not achieved at Week 6, doses were doubled.
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
OPTIMAL STENTS DURING RENAL COLIC
Condition: Ureteral Stent Occlusion
Study type: Interventional

Summary: 
      From June 2018 to October 2018, patients from two distinct clinical centers were
      prospectively enrolled in the study and stratified (non-randomly) into either control group
      A, patients who received polyurethane stents (Rüsch, Teleflex), or experimental group B,
      patients who received silicone stents (Cook Medical). Each participant completed a survey one
      hour after stent insertion, in the middle of the stent dwelling period, and before stent
      removal or ureteroscopy noting body pain and overactive bladder via the visual analog scale
      pain (VASP) and overactive bladder (OAB) awareness tool, respectively. Additionally, the
      successfulness of stent placement, hematuria, number of unplanned visits, and stent
      encrustation rates were assessed within each group.
    


Intervention name(s): polyurethane stent; silicone stent
Intervention type(s): Device; Device
Intervention description(s): patients were prospectively enrolled in the study and stratified (non-randomly) into either group A - polyurethane - control group or group B - silicone - experimental group; silicone stent
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Drug Therapy to Treat Minor Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This 6-month study will compare the effectiveness of citalopram (Celexa®), hypericum (St.
      John's Wort), and placebo for the treatment of minor depression.
    

Detailed description: 
      Minor depression is highly prevalent, causes substantial morbidity and disability, presents a
      serious risk factor for the development of major depressive disorder, yet is under recognized
      and under treated. Researchers have determined that patients with minor depression frequently
      seek treatment from general practitioners and are often treated with prescription
      antidepressants. There is a need to evaluate the effectiveness of St. John's Wort in the
      management of minor depression. If the proposed study demonstrates the efficacy of St. John's
      Wort and/or citalopram, it will suggest treatment paradigms that can be tested and applied in
      primary care settings.

      Subjects participated in a 12-week double-blind randomized study comparing St. John's Wort,
      citalopram, and placebo. Subjects were recruited through clinical referrals and community
      advertising. Data were obtained at the baseline visit (just prior to randomization) and at
      postrandomization visits conducted at 2-week intervals for the next 12 weeks, for a modified
      intent-to-treat sample consisting of all 73 subjects with at least 1 post-randomization visit
      (evaluable sample).
    

Intervention name(s): Citalopram; St. John's Wort; Placebos
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Established Selective Serotonin Reuptake Inhibitor antidepressant; Natural extract from the St. John's Wort plant.; Placebo pill
Other intervention name(s): Celexa, Cipramil; Hypericum
Intervention MeSH terms: Citalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Minor Depression; St. John's Wart
A Study to Evaluate the Appropriateness of the Voriconazole Dosing Regimen
Condition: Fungal Infection
MeSH terms: Mycoses
Study type: Interventional
Phase: Phase 1

Summary: 
      A pilot study was performed to evaluate the appropriateness of the voriconazole dosing
      regimen based on the population pharmacokinetic model and the influence of sex on the
      pharmacokinetics of voriconazole
    


Intervention name(s): Voriconazole Oral Product (Vfend®)
Intervention type(s): Drug
Intervention description(s): To be determined mg of Voriconazole (Vfend®, anti-fungal agent)
Intervention MeSH terms: Voriconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Blood Loss Evaluation Using a Novel Device
Condition: Blood Loss, Surgical; Transfusion; Patient Blood Management
MeSH terms: Hemorrhage; Blood Loss, Surgical
Study type: Observational

Summary: 
      The study´s aim is to evaluate the clinical applicability of the Feature Extraction
      Technology (FET) during a simulated blood loss scenario.
    

Detailed description: 
      In an operating theatre blood loss will be simulated in different scenarios. Expired whole
      blood donations (provided by the German Red Cross, Institute of Transfusions Medicine, Goethe
      University Frankfurt) will be used. Blood will be diluted by full electrolyte solutions .
      Sponges and canisters will be prepared with a predetermined amount of blood.

      Study participants will estimate total blood loss on sponges and canisters. Study members not
      knowing the correct amount of prepared blood will measure the blood loss in sponges and
      canisters by Feature Extraction Technology (FET) and by gravimetric method before and after
      estimation of the participants.
    

Intervention name(s): Feature Extraction Technology
Intervention type(s): Diagnostic Test
Intervention description(s): The study´s aim was evaluation of the clinical applicability of the Feature Extraction Technology (FET) during a simulated blood loss scenario in comparison to visual estimation.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We include healthcare professionals.
Probiotic and Influenza Vaccination to Reducing Influenza-like Illness Incident in Elderly
Condition: Influenza-like Illness
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      To asses the effect of the probiotic and influenza vaccination alone and combination on
      enhancing immune response to influenza-like illness (ILI) and reducing ILI incidence in the
      elderly
    

Detailed description: 
      To see percetange of subjects seroconvertion and seroprotection before and after intervention
      in the elderly (>60 years), and monitored for 6 months.
    

Intervention name(s): Flubio; Lacidofil; Placebo Vaccine; Placebo probiotic
Intervention type(s): Biological; Dietary Supplement; Other; Other
Intervention description(s): Flubio (A/California/7/2009, A/Texas/50/2012 and B/Massachusetts/2/2012) Vaccine 0,5 ml for every subjects The vaccine will be given intramuscularly; Lacidofil (Lactobacillus acidophilus Rossel-52 and Lactobacillus rhamnosus Rosell-11 with maltodextrin 211 mg, magnesium stearat 8 mg and ascorbic acid 1 mg) antibiotic The antibiotic will be given 2 times each day for 6 months; Nacl 0,9% 0,5 ml The placebo vaccine will be given intramuscularly; Capsul
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; Vaccine; Probiotic; Influenza-like Illness