bioihbjkbjnl/mcl2 huggingface dataset:
Multiple Rising Dose Study of BI 144807 Powder in Bottle in Mild Asthmatic Patients
Condition: Healthy; Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      In this trial the safety, tolerability, pharmacokinetics and exploratory pharmacodynamics of
      multiple dose administration of BI 144807 will be investigated in otherwise healthy,
      controlled asthmatic patients
    


Intervention name(s): Placebo to BI 144807; BI 144807
Intervention type(s): Drug; Drug
Intervention description(s): multiple dose (bid); multiple dose (bid, low to high dose)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Depression and Anxiety Reduction Treatment for Suicide
Condition: Anxiety; Depression; Suicide
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders; Suicide
Study type: Interventional

Summary: 
      The purpose of this study is to test the effectiveness and usability of multiple
      computer-based treatments for mood and anxiety relevant risk factors. The target of the
      treatment is related to cognitive stress, which has been shown to be associated with a
      variety of negative mental health outcomes such as Post-Traumatic Stress Disorder, suicidal
      ideation, and substance use disorders.
    

Detailed description: 
      DARTS is a newly developed computerized treatment targeting specific risk factors associated
      with suicide, mood, and anxiety symptoms. Eligible individuals will be randomized to one of
      several conditions. In all conditions, participants will complete various self-report
      questionnaires and a neurophysiology assessment that involves an EEG. Some participants will
      also be asked to complete four additional EEG assessments. In addition, all participants will
      be asked to complete a 1, 3, and 6-month follow-up appointment.
    

Intervention name(s): Psychoeducation and Cognitive Bias Modification
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: computerized intervention; cognitive bias modification; anxiety; mood; perceived burdensomeness; thwarted belongingness; suicide; post-traumatic stress disorder
A Study to Evaluate the Pharmacokinetics and Safety of HCP1704 in Healthy Subjects
Condition: Health, Subjective
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics and
      safety of HCP1704 in healthy subjects.
    


Intervention name(s): HGP1810; HCP1704
Intervention type(s): Drug; Drug
Intervention description(s): HGP1810: Vildagliptin/Metformin; HCP1704: Vildagliptin/Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Open Label Study of the Safety and Contraceptive Efficacy of BufferGel® With Diaphragm
Condition: Contraception
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to study the safety and contraceptive effectiveness of BufferGel
      used with a contraceptive diaphragm.
    


Intervention name(s): Drug: BufferGel® with diaphragm
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Prostate Volume Changes Following Prostate Brachytherapy With Iodine-125 Seeds
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      The size of the prostate changes due to insertion of the radioactive seeds. We will measure
      the prostate size, before and after the procedure.
    

Detailed description: 
      The prostate size will be measured using the TRUS and CT scan on days -1, 0, 1, 9, 30, and 60
      days after the brachytherapy procedure.
    

Intervention name(s): Brachytherapy with Iodine-125 seeds
Intervention type(s): Procedure
Intervention description(s): Brachytherapy of the prostate, and measurements of the prostate volume using CT scan and TURS
Other intervention name(s): Prostate Volume over time
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Prostate Cancer patients
      
Keywords: Brachytherapy; Prostate volume
Recurrence Rate, Risk Factors for the Recurrence, and Quality of Life in Patients With GERD in Korea-an Observational
Condition: The Aim of This Study is to Investigate the Frequency and Related Risk Factors of Recurrence, and Quality of Life in Patients With GERD After Treatment With PPI
MeSH terms: Recurrence
Study type: Observational

Summary: 
      Recurrence rate, risk factors for the recurrence, and quality of life in patients with GERD
      in Korea-an observational study.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with typical reflux symptoms (heartburn or regurgitation) undergone upper
        endoscopy
      
Keywords: GERD; Comparison between ERD and NERD; Rate of complete resolution; rate of recurrence; QOL; To investigate the frequency and related risk factors of recurrence, and quality of life in patients with GERD after treatment with PPI; The aim of this study is to investigate the frequency and related risk factors of recurrence, and quality of life in patients with GERD after treatment with PPI
The Acute Effect of Malt Extract Versus Sucrose on the Response of Glucose and Insulin, Subjective Appetite Sensations and ad Libitum Energy Intake
Condition: Obesity; Diabetes
Study type: Interventional

Summary: 
      Sucrose is the most used sweetener in beverage and foods in Denmark. Other sweeteners with
      other composition and amount of carbohydrates could be of interest in order to decrease the
      glucose and insulin responses after intake of a sweetened beverage/food. Malt extract has a
      sweet flavor but contains a different composition and amount of carbohydrates together with a
      small amount of protein compared to sucrose. Malt extract may therefore be a better
      alternative than sucrose as a sweetener due to a lower increase and more sustained blood
      glucose level. This could be of interest in relation to diabetes and appetite regulation but
      this is yet to be investigated.

      Thus the objective is to investigate the effect of malt extract vs. sucrose on:

        1. 3-hour change in the concentration of glucose and insulin

        2. 3-hour change in subjective appetite sensations (Visual Analogue Scales, VAS scores)

        3. Ad libitum energy intake

      Design: 20 men will participate in the 2-way, randomized, double-blind crossover study. The
      test drinks is isocaloric with 75 g carbohydrates Test drinks: malt extract solution and
      sucrose solution (10%) Three-hour subjective appetite ratings and blood samples will be
      assessed every half-hour. Subsequently, the subjects will served an ad libitum lunch
    


Intervention name(s): The acute effect of malt extract versus sucrose on the response of glucose and insulin, subjective appetite sensations and ad libitum energy intake
Intervention type(s): Other
Intervention description(s): 2-arm crossover study for investigation of the effect of malt extract vs. sucrose on glucose, insulin, subjective appetite sensations and ad libitum energy intake.
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Malt extract; carbohydrate; glucose response; insulin response; Appetite; Appetite regulating hormones
Efficacy of a New Resurfacing Hip Prosthesis
Condition: Osteoarthritis, Hip
MeSH terms: Osteoarthritis, Hip
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the articular surface replacement (ASR) prosthesis
      placed by the conventional positioning method and the ASR prosthesis placed by 'computer
      assisted surgery' (CAS) in variation between pre planned position of the femoral component
      and the actual position of the femoral component of the prosthesis. The hypothesis is that
      this variation is larger with the conventional positioning method than when CAS is used.
    

Detailed description: 
      For patients who suffer from end stage of osteoarthritis of the hip, a joint replacement
      could result in an obvious improvement of the quality of life. However, because of the life
      expectation and high level of activity of young and active patients, the conventional total
      hip replacement does not offer an optimal solution.

      An alternative to a total hip replacement in young and active patients is the resurfacing hip
      prostheses. The articular surface replacement (ASR) hip prostheses can be placed by the
      conventional positioning method and by using 'computer assisted surgery' (CAS). The
      hypothesis is that the positioning of the femoral component by the conventional positioning
      method will show a larger variation between pre planned and actual position than when CAS is
      used.

      This study will compare the results of those who had an ASR prosthesis placed by the
      conventional positioning method with those patients in whom the ASR prosthesis was placed
      using CAS.
    

Intervention name(s): Articular Surface Replacement (ASR) hip prosthesis
Intervention type(s): Device
Intervention description(s): a DePuy ASR™ primary resurfacing femoral and acetabular component (DePuy International Ltd, Leeds, UK). The cement that will be used is one dose of DePuy SmartSet® GHV 40 gram, a high-viscosity cement with gentamycin (DePuy CMW, Blackpool, UK). Instrumentation includes standard ASR™ instruments and Ci™ Software for DePuy ASR™ System1.0.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: "resurfacing hip" [MESH]; "conventional position method"; "surgery, computer-assisted" [MESH]
Anterior Chamber Angle Examination in Angle Closure Suspect Patients
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Observational

Summary: 
      The aim of this study is to detect PACG suspects using both AS OCT and Scheimpflug imaging.
    

Detailed description: 
      Glaucoma is a form of progressive optic neuropathy and is one of the leading causes of
      preventable blindness worldwide. The average life span is increasing leading to more
      individuals developing glaucoma as well as having the disease longer, which makes early
      detection and management very important.[1] Glaucoma is characterized by loss of retinal
      ganglion cells (RGCs) recognized as optic nerve head (ONH) changes, corresponding visual
      field (VF) defects and retinal nerve fiber layer (RNFL) loss. At least 40% of RGCs are lost
      before the VFs show a defect, hence the emphasis on early diagnosis in the stage of glaucoma
      suspect.[2] There are two types of glaucoma suspect: Primary Open angle and primary angle
      closure suspect.(3) Primary angle-closure (PAC) suspects can be detected by the following:
      the trabecular meshwork can only be seen in 180º or less of anterior chamber angle (AC) by
      gonioscopy, the intraocular pressure(IOP) remains within normal limits and no structural
      damage to the optic nerve is present.[4] Time domain Optical coherence tomography (TD-OCT)
      was initially designed to image the posterior segment and retina, but its capability to
      generate cross-sectional images of internal biological structures without contacting the
      ocular surface was quickly adapted to visualize the anterior segment and cornea.[5].

      Spectral domain anterior segment OCT (SD-OCT) technology allow visualizing the anterior
      chamber angle of the eye with high speed and high resolution. Spectral-domain OCT(SD OCT)
      instruments working at 840 nm can reliably identify fine angle structures such as Schwalbe's
      line.(6) Scheimpflug imaging also offers non-contact imaging of the anterior segment.
      Although Scheimpflug photography cannot fully visualize the entire angle, the software
      available on the Pentacam system (Oculus Optikgeräte, Wetzlar, Germany) provides extrapolated
      measurements of the anterior chamber volume (ACV), which have shown promise in screening for
      narrow angles.(7)
    

Intervention name(s): ASOCT; Pentacam
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Anterior segment imaging using RTVue XR 100 Avanti OCT platform (Optovue Inc.,Fairmont, CA).; Anterior segment imaging using Oculus Pentacam HR (Oculus Optikgeräte, Wetzlar, Germany).
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Residents of Minia Governorate diagnosed with SLE with renal affection and without renal
        affection.
      
Keywords: Angle closure; ASOCT
Periarticular Multimodal Drug Injections in Total Knee Arthroplasty
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether periarticular multimodal drug injection
      (PMDI) would provide additional benefits in patients after total knee arthroplasty (TKA) for
      whom contemporary pain control protocols using the continuous femoral nerve block,
      intra-venous patient controlled analgesia (IV-PCA)and preemptive oral medications. We
      hypothesized that PMDI would reduce pain level and consumption of PCA and acute pain rescuer
      and would provide better functional recovery and patient satisfaction. We also hypothesized
      that the incidence of side effects and complications of the PMDI would be similar to the
      No-PMDI.
    

Detailed description: 
      The preemptive multimodal approaches are regarded as a current standard pain management
      protocol. Recently, periarticular multimodal drug injection (PMDI) has been considered to be
      one of the most effective and important component in multimodal approaches. Because the
      contemporary pain management protocol using the regional anesthesia, continuous femoral nerve
      block (FNB) and intravenous patient-controlled analgesia (PCA) has been proved significantly
      improved analgesic effects itself, little information whether the PMDI would provide
      additional pain relief under this pain management protocol is available. Also, because the
      safety of the high dose local anesthetics and narcotics has not been clarified, a selective
      application should be considered to patients who were expected to show better analgesia if
      there were certain patient related factors to predict the additional pain relief effect of
      the PMDI. Thus, this prospective double-blind randomized study was conducted to determine
      whether PMDI would provide additional benefits in patients after total knee arthroplasty
      (TKA) for whom contemporary pain control protocols using the continuous femoral nerve block,
      IV-PCA and preemptive oral medications in terms of pain relief, consumption of PCA and acute
      pain rescuer, patients satisfaction, functional recovery, side effects and complications.
    

Intervention name(s): ropivacaine; morphine sulfate; ketorolac; epinephrine; cefuroxime
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 300mg (0.75%, 40cc) intraoperative periarticular injection; 10mg intraoperative periarticular injection; 30 mg intraoperative periarticular injection; 300 microgram (1:1000) intraoperative periarticular injection; 750mg intraoperative periarticular injection
Intervention MeSH terms: Cefuroxime; Cefuroxime axetil; Ketorolac; Epinephrine; Morphine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: periarticular multimodal drug injection
Influence of Intrapulmonary Percussive Ventilation (IPV) on Gastro-oesophageal Reflux (GOR).
Condition: Gastro-oesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional

Summary: 
      The study evaluates the effect on gastro-oesophageal reflux (GOR) of infants sitting in a
      stable upright position during 20 min. This is an addendum to the previous study with record
      number clinical trials.gov NCT02124863
    


Intervention name(s): sitting position
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gastro-oesophageal reflux; intrapulmonary percussive ventilation; positioning
A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency
Condition: Gout; Hyperuricemia; Arthritis; Joint Disease; Renal Insufficiency
MeSH terms: Arthritis; Gout; Joint Diseases; Renal Insufficiency; Hyperuricemia
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the overall safety and tolerability of ulodesine when combined with allopurinol
      in subjects with moderate renal insufficiency.
    


Intervention name(s): Placebo; Ulodesine (BCX4208) 5 mg; Ulodesine (BCX4208) 10 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral dose administered daily for 84 days.; Oral dose administered daily for 84 days.; Oral dose administered daily for 84 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Gout; Hyperuricemia; Arthritis; Joint Disease; Allopurinol; Renal Insufficiency
A Study to Assess the Safety and Pharmacokinetics of Multiple Ascending Subcutaneous Doses of DS-2325a in Healthy Subjects
Condition: Netherton Syndrome
MeSH terms: Netherton Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      Netherton syndrome (NS) is a rare autosomal recessive disease and no systemic treatment or
      standard of care currently exists for patients with NS. DS-2325a, a specific and potent
      inhibitor of kallikrein 5, is expected to treat NS by replacing a defective gene.
    

Detailed description: 
      This study for DS-2325a will evaluate the safety, tolerability, and pharmacokinetics of
      multiple ascending doses of DS-2325a in healthy participants. DS-2325a will be evaluated
      after subcutaneous (SC) injections.
    

Intervention name(s): DS-2325a; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous injection (starting dose 300 mg); Subcutaneous injection
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Netherton Syndrome; DS-2325a; Healthy Participants
Safety Study of MK-8237 Treatment in House-Dust-Mite Allergic Adolescents (MK-8237-008)
Condition: Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Nonseasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety of two doses (6 Development Units [DU]
      and 12 DU) of MK-8237 sublingual tablets compared to Placebo in adolescents with house dust
      mite-induced allergic rhinitis/rhinoconjunctivitis. The primary hypothesis is that at least
      one dose of MK-8237 sublingual tablet is safe and well-tolerated in adolescents with house
      dust mite-induced allergic rhinitis/rhinoconjunctivitis.
    


Intervention name(s): MK-8237 6 DU; MK-8237 12 DU; Placebo
Intervention type(s): Biological; Biological; Biological
Other intervention name(s): SCH 900237; SCH 900237
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study to Evaluate Safety and Effectiveness of AdvaCoat Sinus Gel
Condition: Ethmoid Sinusitis; Rhinosinusitis
MeSH terms: Sinusitis; Ethmoid Sinusitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of AdvaCoat® sinus gel,
      a nasal/sinus dressing, for adhesion prevention following endoscopic ethmoid sinus surgery.
      Subjects were randomized to receive AdvaCoat applied to the right or left middle meatus
      tissues and Merogel applied to the middle meatus tissues on the opposite side.
    

Detailed description: 
      Chronic rhinosinusitis is a very common condition, affecting 35 million Americans each year.
      All paranasal sinuses need ventilation to prevent infection and inflammation. Sinus
      ventilation occurs through the ostia into the nose. When rhinosinusitis occurs, the mucous
      membranes of the sinuses become swollen, resulting in ostia closure. Functional endoscopic
      sinus surgery (FESS) is a minimally invasive surgical procedure that opens the sinus ostia.

      The most common unwanted side effect of the FESS procedure is the formation of adhesions
      (fibrous bands) in the area of surgery. These bands (adhesions) can prevent proper
      ventilation and drainage from the paranasal sinuses.

      Various hyaluronan based biomaterials are now available and in common use to provide a
      post-surgical nasal dressing which is absorbable, can prevent adhesion formation, and
      eliminate the pain and tissue abrasion caused by removal of non-absorbable nasal packing.

      AdvaCoat is a bioresorbable hyaluronan gel that conforms to mucosal surfaces and provides a
      post-surgical nasal dressing to prevent adhesion formation as tissues heal.
    

Intervention name(s): AdvaCoat sinus gel; Merogel Injectable
Intervention type(s): Device; Device
Intervention description(s): A sterile,viscoelastic, bioresorbable gel composed of highly purified hyaluronan, a naturally occurring constituent of tissues in the body; Bioresorbable hyaluronic acid product
Other intervention name(s): Merogel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: rhinosinusitis, ethmoid