bioihbjkbjnl/mcl2 huggingface dataset:
Cholesterol-lowering Effects of Lupin Protein
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      The objective of the study is to determine the efficacy of lupin protein drinks (Lupinus
      angustifolius Boregine) in humans. Parameters concerning cardiovascular risk factors and the
      metabolism of proteins, lipids and cholesterol will be evaluated.
    

Detailed description: 
      Based on the preliminary finding that a daily dosage of 35 g lupin protein is capable to
      affect plasma lipids positively, the physiological effects of two different daily lupin
      protein dosages will be investigated in two separate study groups (group A: 25 g protein/day;
      group B: 40 g protein/day). Both study groups undergo double-blinded and controlled study
      conditions in a cross-over design.

      In each of the two study groups 35 volunteers with hypercholesterolemia will be allocated to
      one of two randomization groups: After a 1-week run-in period (baseline), half of the 35
      participants of each study group will consume drinks with lupin protein in the respective
      amount (25 g or 40 g protein/day) over a period of eight weeks, the other half will receive
      the analogue amount of milk protein as well incorporated in a drink serving as control. After
      a wash-out period of four weeks, the protein source will be crossed within the two study
      groups for a second intervention period of eight weeks.
    

Intervention name(s): Protein drink - low dosage; Protein drink - high dosage
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The subjects will consume 500 mL of a protein drink containing 25 g protein (lupin protein or reference protein) per day over eight weeks each. After a one-week run-in period, each volunteer has to pass both protein-periods in different order with a four-week wash out period in between.; The subjects will consume 500 mL of a protein drink containing 40 g protein (lupin protein or reference protein) per day over eight weeks each. After a one-week run-in period, each volunteer has to pass both protein-periods in different order with a four-week wash out period in between.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dietary protein; Lupin protein; Cholesterol metabolism; Protein metabolism; Hypercholesterolemia; Protein-enriched drinks
Fiber Intake & Fecal Bulk Enhanced Response
Condition: Fecal Bulk; Intestinal Health
Study type: Interventional

Summary: 
      Some dietary fibres, including wheat fibres, have shown to increase fecal bulk and improve
      stool. In previous studies, this effect on fecal bulk was especially studied for intact wheat
      fibers. Moreover, in most studies, the wheat fiber was offered daily as a single dose in
      cereals. In this study, we investigate whether an increased intake of extracted wheat fiber,
      implemented at several time points in a normal daily dietary pattern, can also increase fecal
      bulk and improve stool frequency and consistency. Here we want to demonstrate that an
      increase in VITACEL Wheat Fiber intake will enhance fecal bulk, both wet and dry weight and
      that the enhanced wheat fiber intake will also increase stool frequency and consistency. The
      study is a double-blind crossover design in which the intervention is based on products
      enriched by VITACEL Wheat Fiber and control products. Both the control and fiber-enriched
      intervention will last for 10 days with a wash-out period of at least 4 days. The study will
      be conducted with 25 healthy male human volunteers in the age between 18-70 years old.Persons
      will be assigned to the intervention groups. In one of the intervention periods participants
      receive 'control boxes' with products low in wheat fiber and in the other period they will
      receive boxes with products enriched with VITACEL Wheat Fiber. During an intervention period
      of 10 days participants will receive 10 boxes, one for each day. In the last 5 days of the
      intervention + 1 additional day after the intervention (so in total 6 days), participants
      will collect their fecal samples to analyse fecal bulk. Daily also a diary has to be kept and
      questionnaires have to be completed to check compliance to the intervention and assess stool
      consistency, gut-related complaints.
    


Intervention name(s): High wheat fiber; Low fiber
Intervention type(s): Other; Other
Intervention description(s): Daily increased fiber intake by 18-22 grams/day. Products are provided in boxes that must be consumed each day during the intervention.; Control low fiber intervention. Products are provided in boxes that must be consumed each day during the intervention.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Fibre; diet; fecal bulk
Study to Assess Safety and Efficacy of Nephrosolid Tbs to Stimulate Urinary Output in Non-patient Volunteers
Condition: Urine Specimen Collection
Study type: Interventional
Phase: Phase 3

Summary: 
      Fluid intake and urinary output are measured with /without intake of Nephrosolid tablets in
      acute ( 1 day application ) and chronic ( 28 days application) therapy.
    

Detailed description: 
      To evaluate safety and efficacy of Nephrosolid tbs in the stimulation of urinary output in
      healthy volunteers, all participants in this open-label study will be asked to record their
      fluid intake and output on day 0 (without study medication), on day 1 (with 3 x 2 tablets
      study medication, to be taken 1/2 hour before meals) and on day 28 (with 2 x 1 tablets study
      medication, morning and noon half an hour before meals) and to take 2 x 1 tablet of
      Nephrosolid on days 2-28. Subjects will complete a diary during the study to record the
      tablets taken, amount of fluid consumed, weight, physical activity, and urinary measurement.
      Safety labs (hematology, clinical chemistry) will be performed at each study visit on days -1
      and 29.
    

Intervention name(s): Nephrosolid tablets
Intervention type(s): Drug
Intervention description(s): Adminstration of drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus Vaccine With Another Vaccine in Healthy Female Subjects
Condition: Infections, Papillomavirus
MeSH terms: Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      Infection with human papillomavirus (HPV) has been clearly established as the central cause
      of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and
      thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical
      cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescent
      vaccination programs. Therefore, this Phase IIIb study is designed to evaluate the safety and
      immunogenicity of co-administering a commercially available vaccine with GSK Biologicals'
      HPV-16/18 L1 AS04 (Cervarix ®) vaccine as compared to the administration of either vaccine
      alone. This Protocol Posting has been updated in order to comply with the FDA AA, Sept 2007.
    


Intervention name(s): Cervarix™; Twinrix ™ Paediatric
Intervention type(s): Biological; Biological
Intervention description(s): Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose; Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose
Other intervention name(s): HPV vaccine; GSK Biologicals' HPV-16/18 L1 AS04
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Human papillomavirus infection,; cervical cancer; HPV vaccine,
In-office Hysteroscopic Laser Ablation for Symptomatic Submucous Uterine Fibroids
Condition: Laser Hysteroscopic Ablation of Submucous Myoma
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional

Summary: 
      To evaluate feasibility and efficacy of in-office hysteroscopic ablation of submucous uterine
      fibroid using diode laser
    

Detailed description: 
      A pilot study was conducted between January 2018 and January 2019 in a tertiary care
      university hospital. Patients with at least one symptomatic, class 0-2 of FIGO
      classification, uterine fibroid of ≤ 7cm in size were eligible for inclusion. Evaluation of
      the changes in fibroid size and vascularity was performed using 3D Doppler ultrasonography.
      Vaporization of the fibroid core was conducted using a 1470nm wavelength diode laser inserted
      through the hysteroscope's working channel. Primary outcome was the evaluation of the fibroid
      volume before and at 2 months after the procedure.
    

Intervention name(s): hysteroscopic ablation of submucous uterine fibroid using diode laser
Intervention type(s): Device
Intervention description(s): patients with symptomatic submucosal fibroids (heavy menstrual bleeding) were elected for hysteroscopy and laser ablation of the myoma
Intervention model: Single Group Assignment
Intervention model description: patients with symptomatic submucosal fibroides were elected for hysteroscopy laser ablation of the fibroid
Masking: None (Open Label)
Primary purpose: Treatment
An Open-Label, Phase I, Escalating Dose Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of PDS0101
Condition: High-risk HPV Infection and Biopsy-proven CIN1
MeSH terms: Infections; Papillomavirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I, open-label, sequential-cohort, ascending multiple-dose study to evaluate the safety
      and tolerability of escalating doses of PDS0101 in female subjects with high-risk HPV
      infection and biopsy-proven CIN1. The study will include 3 cohorts of 3 to 6 subjects each
      based on a modified "3 + 3" dose-escalation study design. The study will be initiated with
      Cohort 1 and progress through Cohort 3, with each subsequent cohort receiving a higher dose
      of PDS0101. Successive cohorts will receive a constant dose of HPV-16 E6 and E7 peptides. All
      subjects will receive 3 vaccinations SC given approximately 21 days apart. Dosing and dose
      escalation will be based on safety evaluation for determination of potential dose-limiting
      toxicity (DLT).
    


Intervention name(s): R-enantiomer of 1,2-dioleoyl-3-trimethylammonium-propane chloride + Peptides from HPV-16 E6 and E7
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Colchicine in Vascular Inflammation Assessed With PET Imaging
Condition: Atherosclerotic Vascular Disease
MeSH terms: Vascular Diseases; Atherosclerosis; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to assess the effects of colchicine on vascular inflammation
      measured by (FDG)-PET imaging in patients with atherosclerotic vascular disease. This effect
      will also be measured by soluble plasma biomarkers. Finally, an optional pharmacogenomic
      investigation will be performed to identify genetic biomarkers of patient response.
    

Detailed description: 
      This is an interventional trial targetting patients 18 years old or older with a carotid
      artery or an ascending aorta to background ration (TBR) of ≥1.6 as determined by 18
      fluorodeoxyglucose (18F-FDG) uptake measured by positron emission tomography (PET) as
      evidence of atherosclerotic plaque inflammation.

      Following randomization,patients will be followed over a period of 6 months (24 weeks),
      through 2 phone contacts at 6 and 20 weeks and 2 on-site visits at 12 and 24 weeks.

      Each on-site visits will include blood draws to monitor routine chemistry and hematology,as
      well as biomarkers and lipid profiles.

      Each phone contacts will include monitoring of patient's general health and well-being.

      PET imaging will be performed at baseline and at the 24-weeks visit.

      Safety in this study will be assessed by clinical laboratory parameters, physical
      examinations, ECGs, vital signs, and the frequency and intensity of clinical adverse events
      (AEs).

      The Montreal Health Innovations Coordinating Center (MHICC) will be responsible for
      processing and quality control of the data. Project management will be carried out as
      described in the MHICC standard operating procedures (SOPs) for clinical studies. The
      handling of data, including data quality control, will comply with all applicable regulatory
      guidelines, MHICC SOPs and the study Data Management Plan. As such, a MHICC medical monitor
      will be appointed to the trial as the serious adverse event reporting contact (24/7).
    

Intervention name(s): Colchicine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0.6 mg a day of active treatment or placebo for 24 weeks; Sugar,given once daily, over 6 months.To mimic active treatment
Other intervention name(s): Colchicum autumnale; Sugar
Intervention MeSH terms: Colchicine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Atherosclerosis; Vascular; Cardiovascular; Coronary artery disease; Imaging; PET; Scan; anti-inflammatory
Clinical Efficacy Of 810 Nanometer Diode Laser As An Adjunct To Mechanical Periodontal Treatment Of Residual Periodontal Pockets
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis; Periodontal Pocket
Study type: Interventional

Summary: 
      Background: Aim of this randomized controlled parallel-designed study was to evaluate the
      effects of diode laser as an adjunct to mechanical periodontal treatment on clinical
      parameters and gingival crevicular fluid (GCF) volume of the residual pockets diagnosed
      following initial periodontal treatment in chronic periodontitis (CP) patients.

      Methods: A total of 84 residual pockets on single-rooted teeth in 11 CP patients were
      included and randomly assigned into 3 groups. Residual pockets were treated either only by
      mechanical treatment (Group M) (n=28), only by diode laser disinfection (Group L) (n=28) or
      by combination of these techniques (Group M+L) (n=28). Plaque index, gingival index (GI),
      bleeding on probing (BoP), probing depth (PD), clinical attachment level and gingival
      recession were assessed at baseline and 8 weeks after treatment of residual pockets. GCF
      samples were collected at baseline, 1 and 8 weeks after treatment.
    


Intervention name(s): 810 Nanometer Wavelenght GaAlAs Diode Laser; Gracey curettes
Intervention type(s): Device; Device
Intervention description(s): FDA approved 810 nanometer GaAlAs Diode Laser
Other intervention name(s): CHEESE®, Gigaa Laser, China; Hu-Friedy, SG 5/6, 7/8, 11/12, 13/14, Hu-Friedy Ins. Co., USA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic periodontitis; dental scaling; gingival crevicular fluid; lasers; periodontal pocket; root planing
Effect of Progesterone on Latent Phase Prolongation in Patients With Preterm Premature Rupture of Membranes
Condition: Preterm Premature Rupture of Membrane
MeSH terms: Premature Birth; Fetal Membranes, Premature Rupture; Rupture
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to assess the efficacy of 17-hydroxyprogesterone caproate (17P)
      therapy on the latency period in pregnant women with Preterm premature rupture of membranes.
    

Detailed description: 
      After taking informed written consent, the recruited patients will be subjected to the
      following:

        1. Detailed history

             -  Personal History: Name, age ,residence ,special habits of medical importance

             -  Obstetric history: first day of last menstrual period for accurate estimation of
                gestational age and antenatal care

             -  Past history: history of any medical disorder or surgical history with particular
                emphasis on prior PPROM or preterm labor

             -  History of the present pregnancy: Medical or surgical condition to define high risk
                pregnancy.

        2. Examination of the patients General examination: blood pressure, pulse, temperature

           Abdominal examination:

             -  Inspection: fundal level, scars, umbilicus.

             -  Palpation: presence of contractions, fetal lie and presentation.

             -  Pelvic Examination only by sterile speculum to exclude cord prolapse , bloody
                liquor and cervical dilatation and effacement

             -  Non stress test to ensure reassuring fetal well being

             -  Ultrasound examination to:-

                  -  Assess fetal viability.

                  -  Amniotic fluid index.

                  -  Determine gestational age.

                  -  Exclude major anomalies.

                  -  Placental location.

        3. Baseline laboratory investigations:

             -  Complete blood count (CBC).

             -  Prothrombin time (PT).

             -  Activated partial thromboplastin time (aPTT).

             -  Liver and kidney function.

      The included patients were randomized using sealed opaque envelope method into one of two
      groups:

      Group I (study group): in which 17-hydroxyprogesterone caproate (17P) (250 mg in castor oil,
      1 mL total volume, intramuscular injection weekly) will be administered.

      Group II (control group): in which an identical-appearing placebo (1 mL castor oil only) will
      be administered.
    

Intervention name(s): 17-hydroxyprogesterone caproate; Castor Oil
Intervention type(s): Drug; Drug
Intervention description(s): intramuscular injection weekly; intramuscular injection weekly
Intervention MeSH terms: Castor Oil; 17 alpha-Hydroxyprogesterone Caproate; 11-hydroxyprogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
54135419SUI3001: A Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Participants Assessed to be at Imminent Risk for Suicide
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major; Suicide; Suicidal Ideation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the efficacy of intranasal esketamine 84 milligram
      (mg) compared with intranasal placebo in addition to comprehensive standard of care in
      reducing the symptoms of Major Depressive Disorder (MDD), including suicidal ideation, in
      participants who are assessed to be at imminent risk for suicide, as measured by the change
      from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) total score at 24
      hours post first dose.
    

Detailed description: 
      This is a randomized (study medication assigned to participants by chance), double-blind
      (neither the researchers nor the participants know what treatment the participant is
      receiving), placebo-controlled (an inactive substance which contains no drug) that is
      compared in a clinical trial with a drug to test if the drug has a real effect), multicenter
      (when more than one hospital or study team work on a medical research study) study. Study
      will enroll participants with suicidal ideation who are assessed to be at imminent risk for
      suicide. The study will consist of a screening evaluation performed within 48 hours prior to
      the Day 1 intranasal dose immediately followed by a 25-day double-blind treatment phase (Day
      1 to 25), and a 65 day follow-up phase (Day 26 to Day 90). The total study duration for each
      subject will be approximately 13 weeks. Participants' safety will be evaluated throughout the
      study. If you or a loved one are having thoughts of suicide, please seek immediate medical
      help. Go to the emergency room or call the National Suicide Prevention Lifeline at
      1-800-273-8255.
    

Intervention name(s): Esketamine; Placebo; Standard of Care
Intervention type(s): Drug; Other; Other
Intervention description(s): Intranasal esketamine solution 84 milligram (mg); Intranasal Placebo solution; The standard of care antidepressant treatment (antidepressant monotherapy or antidepressant plus augmentation therapy) will be determined by the treating physician(s) based on clinical judgement and practice guidelines prior to randomization, and the treatment will be initiated on Day 1.
Intervention MeSH terms: Esketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparative Assessment of the Clinical Utility of Ovarian Stimulation With Menotropin Versus Menotropin Plus GnRH Antagonist
Condition: Sterility
MeSH terms: Infertility
Study type: Observational

Summary: 
      To assess the effectiveness of protocols of ovarian hyperstimulation combining urinary
      gonadotrophins + GnRH antagonist vs urinary gonadotrophins, to achieve clinical pregnancy in
      females undergoing intrauterine insemination.

      Study hypothesis: protocols combining urinary gonadotrophins + GnRH antagonist should be more
      effective than monotherapy.
    


Intervention name(s): hMG-HP; hMG + GnRH antagonist
Intervention type(s): Drug; Drug
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Females affected by sterility able to undergo intrauterine insemination
Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy
Condition: Sedation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of the sedation for
      Remimazolam or Propofol in patients undergoing diagnostic upper GI endoscopy.
    

Detailed description: 
      This is a multi-center, ,parallel-group, single blind study using Remimazolam or propofol for
      sedation in patients undergoing diagnostic upper GI endoscopy.Subjects are randomized to
      different treatment groups (including 1 for Remimazolam Tosilate and 1 for propofol).
      Fentanyl are permitted during a diagnostic upper GI endoscopy.Efficacy and safety profiles of
      Remimazolam Tosilate are to be evaluated.
    

Intervention name(s): Remimazolam Tosilate; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): Initial dose plus supplemental doses as necessary; Initial dose plus supplemental doses as necessary
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other