bioihbjkbjnl/mcl2 huggingface dataset:
The Acute Effect of Vaping on Food Intake
Condition: Energy Intake; Food Intake; E-Cig Use; Appetite
Study type: Interventional

Summary: 
      This study assesses the acute effects of a standardized 20-minute vaping episode compared to
      a non-vaping control condition on ad libitum food intake during a 30-minute buffet meal,
      occurring approximately 45 minutes after the vaping episode
    

Detailed description: 
      Weight control is a common motive for cigarette smoking and nicotine has been shown to
      suppress appetite and increase resting metabolic rate, and also serves as a behavioral
      alternative to eating or a distraction from hunger or food craving. Data on the acute effect
      of e-cigarette use ('vaping') on ad libitum food intake are non-existent. Given that many
      e-cigarette users report vaping for weight control and that certain e-cigarettes are being
      actively marketed for weight management and/or suppression of food cravings, addressing this
      research gap is of the utmost importance.
    

Intervention name(s): Vaping condition; Control condition
Intervention type(s): Other; Other
Intervention description(s): Participants will be asked to use a JUUL device to vape 20 puffs over 20 minutes. Participants will use JUUL pods with ~5% nicotine by weight. The anticipated amount of nicotine that will be absorbed with 20 puffs is approximately 1.6 mg, which is equal to approximately 1.5 cigarettes.; Participants will have access to an uncharged JUUL device with an empty pod for 20 minutes.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study consists of a baseline assessment which is followed by two within-subject, laboratory conditions that differ by the product used: 1) JUUL e-cigarette with a 5% nicotine pod, 2) no active e-cigarette use (uncharged JUUL with empty pod). The condition orders (i.e., 1 then 2, or 2 then 1) will be randomly ordered and assigned following enrollment. During the vaping condition, participants will be asked to take 20 e-cigarette puffs over 20 minutes before consuming an ad libitum buffet meal. During the alternative control condition, participants will have access to an uncharged JUUL with an empty pod for 20 minutes (instead of vaping) before consuming an ad libitum buffet meal.
Masking: None (Open Label)
Primary purpose: Other
A Study of Brensocatib Following a Single Oral Administration in Participants With or Without Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of the study is to determine the pharmacokinetics (PK) following a single
      oral dose administration of brensocatib, safety, and tolerability of brensocatib when
      administered to participants with impaired renal function and in healthy participants.
    


Intervention name(s): Brensocatib
Intervention type(s): Drug
Intervention description(s): Oral tablet
Other intervention name(s): INS1007
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Brensocatib; INS1007
Absorption, Metabolism and Excretion of Apigenin and Apigenin Glycosides
Condition: Healthy
Study type: Interventional

Summary: 
      Probe dietary intervention study in healthy young adult males to evaluate the concentration
      of apigenin derived metabolites in plasma and urine after single acute intakes of different
      apigenin-containing test materials.
    

Detailed description: 
      Flavonoids, including the sub groups of Flavones (FO) are plant-derived compounds commonly
      present in the human diet. Examples of FO-containing foods and beverages are parsley, celery,
      and chamomile. The study described below will provide initial information of apigenin derived
      metabolites in humans. The investigators suggest the information that will be obtained from
      the outlined work will be particularly timely given increasing interest in the putative
      health effects of FO intake in humans.

      This study consisted of two parts. The first part consisted of a probe study in which the
      investigators investigated the absorption and metabolism from four flavone-containing test
      products. The second phase investigated absorption and metabolism after the intake of a
      flavone-containing parsley drink.
    

Intervention name(s): Chamomile Tea; Parsley based drink; Parsley Yogurt; Apigenin; Parsley-based drink (II)
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Chamomile Tea in 300mL hot water; 3.2 g dried parsley in 300mL hot water; 3.2 g dried parsley in 100g plain yogurt; Apigenin capsule mixed with 300mL hot water; 3.2 g dried parsley in 300mL hot water
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Cross-over dietary intervention study in healthy young adult males
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: flavone; ADME; apigenin; parsley; chamomile; polyphenols
Effect of Plasma Rich in Growth Factors in Rotator Cuff Tendinopathy
Condition: Rotator Cuff Tendinopathy
MeSH terms: Tendinopathy
Study type: Interventional
Phase: Phase 3

Summary: 
      The overall objective of the study is to assess the effectiveness of the treatment of
      degenerative rotator cuff tendinopathy using the application of plasma rich in growth factors
      (PRGF).

      Main objective:

      To show more effectiveness after 6 months of treatment with PRGF, with an improvement in the
      reference test of more than 15% compared to the treatment with corticosteroids.

      Secondary objective:

        -  To assess the efficacy of the treatment after 12 months.

        -  Quantification of platelet levels in patients treated with plasma rich in growth factors
           and its correlation with the clinical effect.
    

Detailed description: 
      Study Group. PRGF

      Blood extraction was performed in the pre-surgical area using a vacuum system. A total of 20
      ml of blood (4 samples of 5 ml) per patient was collected in sterile sodium citrate tubes.
      PRGF was obtained following Anitua's technique. The tubes with citrated blood were
      centrifuged at 1,800 rpm for 8 min to obtain a concentrate of platelets suspended in plasma,
      which was separated into three fractions. Pipetting was carried out with extreme care in all
      steps, particularly in the last fraction where, in order to avoid inflammation, leukocytes
      present in the lowermost portion of the centrifuged plasma were not aspirated. PRGF was
      activated by adding calcium chloride 10%,immediately before infiltration. The proportion
      required for PRGF activation is 50 ml of activator per 1,000 ml of PRGF. Separation of plasma
      into three fractions and subsequent activation of the fractions for injection was performed
      in a laminar flow chamber.

      Between the collection of blood and its subacromial administration must not exceed 90 minutes
      to avoid contamination.

      Control group: Celestone Cronodose® (bethametasone).

      They were given 3 infiltrations of 2 cc of Celestone cronodose® (bethametasone) every 21 days
      (If necessary, it could be administered after an application of a small quantity of a local
      anaesthetic).
    

Intervention name(s): Plasma rich in growth factors (PRGF); Celestone cronodose (Bethametasone)
Intervention type(s): Biological; Drug
Intervention MeSH terms: Betamethasone; Mitogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: plasma rich in growth factors, tendinopathy, traumatology; ,rotator cuff, effectiveness, plasma rich in platelets
Manual or Digitally Guided Surgical Technique for Replacing Single Tooth Edentulism by Means of Sub-crestally Placed Implants. A 3-year Parallel Randomized Clinical Study on Marginal Bone Levels Stability
Condition: Dental Implant; Marginal Bone Loss; Peri Implant Health; Supral Tissue Height
Study type: Interventional

Summary: 
      The aim of the present prospective study was to investigate after a 2-year of follow-up any
      influence of the surgical technique, manual or digitally guided, on peri-implant marginal
      bone levels stability in implants placed 1 mm sub-crestally.

      Patients were treated by means of platform-switched implants provided with a 5 degrees
      internal conical connection and supporting single screw-retained fixed crowns. Marginal bone
      level (MBL) measured at prosthesis installation (t0) at 1 (t1), 2 (t2) and at 3 years of
      follow-up visit (t3) were considered. MBL change from t0 to t3 was investigated. The distance
      between the implant neck and the first radiographically detected bone to implant contact was
      considered to evaluate the bone loss. Two groups were considered: Test Group (GD) for implant
      sites treated with a digitally guided surgery procedure. Control Group (FH) for implants
      surgically placed without digitally guided surgery, respectively. All the procedures were
      performed by an experienced operator. Additionally, for both groups MBL changes were
      correlated to different supra-crestal soft tissue height (STH) amounts: less than 3 and ≥ 3
      millimeters, respectively. Peri-implant soft tissue parameters such as probing depth (PPD),
      modified Sulcus Bleeding Index (mBI) and modified Plaque Index (mPI), were assessed for all
      the restorations included.
    


Intervention name(s): Implant placement
Intervention type(s): Procedure
Intervention description(s): Implants were placed by means of a template for a guided surgery approach (GD Group) or with a standard free-hand surgical approach without any additional device (FH Group). A non expert doctor (less that 20 implants placed in the professional activity) was selected for the procedures related to the GD Group; a skilled operator (more than 1000 implants placed in the professional activity) was selected for the procedures related to the FH Group, respectively.
A two-stage surgical technique was chosen. Implants were placed (Anyridge, Megagen Implants, Seoul, Korea) 1 mm below the crestal level, as recommended by the manufacturer. After flap elevation the height of the supra-crestal soft tissue (STH) was measured by means of a calibrated probe.
An inter-implant distance of 3 mm at least, and/or an interproximal space from 1.5 to 3 mm between an implant and the adjacent tooth were observed.
Flaps were sutured over the implants to allow a submerged healing.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Influence of Hydroxyehtyl Starch (HES) on Hemorehology, Coagulation and Elimination Kinetics
Condition: Stroke Patients Presenting Within 24 Hrs of Onset of Symptoms
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The use of HES has been found clinically to improve patients with stroke if administered
      within a window period by means of hemodilution to improve rehology. We propose to see the
      effects of long term administraion of HES in the amounts required for treating stroke
      patients and study the effects on the kinetics of HES, its effects on coagulation and
      hemorheology.
    

Detailed description: 
      Patients with stroke benefit with hemodilution when administered HES in a window period and
      continued for a period of 10 days. Hemodilution improves the hemorheology and thus possibly
      preserves the cerebral tissues in the penumbra regions of affected vessels.

      We propose to see the effects of prolonged administration of HES from different makes and
      study the kinetics, hemorehology and coagulation parameters by TEG as there is no literature
      on kinetics and coagulation follwing prolonged use in stroke patients and also study their
      neurological outcomes.

      Patients presenting to the Emergency department or outpatient department within 24 hrs of
      manifestation of symptoms will be recruited to the study after taking informed consent in a
      language the patients/ family understand by the study personnel identified and authorized to
      do the same.

      The patients will then be randomly allocated to receive HES of either make for 10 day with 10
      patients in each group.

      The randomization is by random number generation by computer.

      The product is blinded to the patient and observer by black cover with only the label A OR B
      of each group.

      Blood Samples will be drawn at time of randomization, after 3, 5 and 10 days for rehological,
      coagulation effects and kinetics of HES, stored as per requirements and analyzed. Routine
      biochemical tests as prescribed by the physician will be undertaken as required.

      Satistical analysis of data will be done by SPSS.
    

Intervention name(s): HES administration; Hydroxy Ethyl Starch administration to stroke patients
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Stroke, HES, Coagulation, Kinetics, Hemorehology
Effect of a Multiple-dose Oral Administration of CG5503 PR on the Electrical Activity of the Heart in 48 Healthy Men and Women
Condition: Prolonged QTc Interval; Pharmacokinetic
Study type: Interventional
Phase: Phase 1

Summary: 
      The effect of multiple oral administration of two doses of CG5503 PR (prolonged release)
      compared to placebo on the electrical activity of the heart were investigated. The rationale
      to perform this study was to exclude any effect of CG5503 on the heart rhythm. This study was
      a randomised, double-blind, double-dummy, placebo- and moxifloxacin-controlled, 4-way
      cross-over study. Participants were given a combination of either CG5503 PR and placebo
      (medication with inactive ingredients which looks like the study drug) or moxifloxacin and
      placebo. Moxifloxacin was used as a positive control. It has consistently shown that it has
      an effect on the heart rhythm.

      Within 14 days prior to the first dosing, participants had a physical examination, a 12-lead
      electrocardiogram (ECG) was recorded and haematological, serological, biochemical, and urine
      analyses took place. A blood sample for optional genotyping of genes responsible for long QT
      syndrome was taken. During each dosing session, the participants were confined in the evening
      before baseline assessments were performed and stayed in the clinic until 48 hours after the
      last dosing. Study medication was administered on Day 1 and 2 in the morning (0.5 hours after
      breakfast) and in the evening (1.5 hours after dinner), and on Day 3 in the morning (0.5
      hours after breakfast). Dosing was separated by at least 7 days between the last dosing of
      each period and the first dosing of next period. Interim analysis of ECG-data were performed
      after completion of 24 participants (group 1) with possible subsequent adjustment of sample
      size for group 2.
    


Intervention name(s): 100 mg CG5503 (tapentadol hydrochloride) PR tablet; Placebo matching CG5503 PR tablet; Placebo matching moxifloxacin capsule; 400 mg Moxifloxacin tablet (overencapsulated)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 100 mg CG5503 (tapentadol hydrochloride) PR tablet.; Matching placebo tablet to CG5503 PR tablet.; Matching placebo capsule to moxifloxacin capsule.; Overencapsulated 400 mg Moxifloxacin tablet.
Intervention MeSH terms: Moxifloxacin; Tapentadol; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study was a randomized, double-blind, double-dummy, placebo- and moxifloxacin-controlled, 4-way cross-over study. The randomization was in the ratio 1:1:1:1. In all treatments the amount of administered tablets and capsules were the same. At the lower dose step the amount of tablets/capsules was adjusted with matching placebos. All study procedures were the same, irrespective of whether active compound, positive control or placebo was administered.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: QT/QTc Interval
RAD001 Plus Best Supportive Care (BSC) Versus BSC Plus Placebo in Patients With Metastatic Carcinoma of the Kidney Which Has Progressed After Treatment With Sorafenib and/or Sunitinib
Condition: Metastatic Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess whether daily treatment with RAD001 could slow the growth and spread of metastatic
      carcinoma of the kidney. The safety of RAD001 was also to be studied in this trial.
    


Intervention name(s): RAD001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The dose of RAD001 was 10 mg/day. Patients were instructed to take two tablets (5 mg each) by mouth every day.
Other intervention name(s): Everolimus
Intervention MeSH terms: Everolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: advanced kidney cancer; everolimus; kidney cancer; oral therapy
A Study to Evaluate Changes in Nasal Airflow of Loratadine/Pseudoephedrine Tablet and Fluticasone Propionate Nasal Spray in Subjects Following Allergen Exposure
Condition: Rhinitis, Allergic
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to evaluate changes in nasal airflow caused by loratadine 5
      mg/pseudoephedrine sulfate 120 mg (Claritin D) tablet and fluticasone propionate 50 mcg per
      spray nasal spray (Flonase) in subjects suffering from nasal congestion and other allergy
      symptoms.
    


Intervention name(s): loratadine + pseudoephedrine sulfate (BAY818725/Claritin-D); Placebo tablet; Fluticasone Propionate; Placebo spray
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single dose of Loratadine/pseudoephedrine in tablet 5 mg/120 mg orally; Placebo tablet orally; Fluticasone Propionate Nasal Spray 50mcg per spray, 2 sprays per nostril; Placebo Nasal Spray, 2 sprays per nostril
Intervention MeSH terms: Fluticasone; Xhance; Loratadine; Pseudoephedrine; Ephedrine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clinical Evaluation of a Daily Wear Reusable Multifocal Optical Design in a Presbyopic Population
Condition: Visual Acuity
Study type: Interventional

Summary: 
      The clinical study is a bilateral, single-masked (partial), single-arm, clinical trial. A
      total of approximately 60 eligible subjects both near-sighted and far-sighted, will be
      targeted to complete the study. Subjects will be fit in the study lens for approximately 2-4
      days then undergo lens optimization, if required. Subjects will then be given a new pair of
      lenses that will be worn for approximately 2 weeks.
    


Intervention name(s): JJV Investigational Multifocal Contact Lens; ACUVUE OASYS® with HYDRACLEAR® PLUS
Intervention type(s): Device; Device
Intervention description(s): TEST Lens; The spherical test lens was used in the troubleshooting steps only for low ADD subjects who have reported a distance vision complaint.
Other intervention name(s): senofilcon A
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Severe Necrotizing Enterocolitis in Preterm Newborns <1500g Using Probiotics
Condition: Infectious Diseases
MeSH terms: Communicable Diseases; Infections; Enterocolitis; Enterocolitis, Necrotizing
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to know the effects of probiotics on the incidence of
      Necrotizing Enterocolitis (NEC) in preterm infants less than 1500 g.
    

Detailed description: 
      The investigators performed a clinical, randomized, double-blind trial in preterm infants
      <1500g from March 1, 2010 to February 28, 2012. Group A received enteral stimulation trophic
      five days and later increments 20ml/k/day of breast milk or formula for premature; the group
      B apart from the above the probiotic Lactobacillus acidophilus (boucardii strain) 1 X109
      colonic forming unit (CFU)/ day for 4 weeks was added. Gastric tolerance, evolution, reason
      for discharge, and the development of Necrotizing enterocolitis was monitored. The diagnosis
      of Necrotizing enterocolitis was made by the treating physician according to Bell's criteria
      and was blinded to group assignments.The formulas were prepared by one of the investigators
      according to the group each patient was assigned. Using sterile technique, the probiotic with
      1x109 (CFU) Lactobacillus acidophilus (boucardii strain) was added at a dose of 125 mg/
      kg/dose twice daily for 4 weeks to fresh supplement breast milk or formula for preterm
      infants. In case of control group only breast milk or formula for preterm infants was used.

      All formulas were labeled for each patient and were delivered to the nurse in charge of
      infant feeding at 9:00 and 21:00 h.

      Characteristics of Sample size and statistical analysis:

      Sample size showed that the investigators needed 190 total preterm infants, based on the
      expected 50% decrease in the incidence of severe necrotizing enterocolitis in preterm
      neonates who received probiotics compared with control group with α 0.05 and β 0.20.
      Student´s t test or Mann Whitney U test were performed for mean differences regarding the
      general characteristics in the two study groups, Chi square or Fisher´s test for differences
      in proportions for mortality and complications between groups.
    

Intervention name(s): probiotics Lactobacillus acidophilus boucardii
Intervention type(s): Dietary Supplement
Intervention description(s): Using sterile technique, the probiotic with 1x109 [CFU] Lactobacillus acidophilus boucardii strain was added at a dose of 125 mg/ kg/dose twice daily for 4 weeks to fresh supplement breast milk or formula for preterm infants.
Other intervention name(s): Gastric tolerance, characteristics of discharges, evolution, reason for discharge, and the development of NEC was monitored.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Necrotizing enterocolitis; Probiotics; Preterm newborns