bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Foeniculum Vulgare Ironing on Gastrointestinal Recovery After Colorectal Resection
Condition: Colorectal Surgery; Foeniculum; Ileus
MeSH terms: Ileus
Study type: Interventional
Phase: Phase 2

Summary: 
      Chinese Medicine Ironing using Foeniculum vulgare has been applied in some departments to
      promote bowel function recovery, but the efficacy of ironing therapy remains uncertain after
      colorectal resection surgery.
    

Detailed description: 
      Postoperative ileus is one of the most common complications after abdominal surgery. It
      refers to obstipation and intolerance of oral intake due to nonmechanical factors that
      disrupt the normal coordinated propulsive motor activity of the gastrointestinal tract
      following abdominal or nonabdominal surgery. When the expected period of gastrointestinal
      recovery time extends beyond what is acceptable, the patient is diagnosed as having a
      "pathologic" postoperative ileus (POI), which leads to patient discomfort, dissatisfaction,
      prolonged hospitalization and increased medical expenses. The incidence of POI is about
      17%~24% after abdominal surgery. Chinese Medicine Ironing using Foeniculum vulgare has been
      applied in some departments to promote gastrointestinal function recovery as a empiric
      therapy. However, the definite efficacy of Foeniculum vulgare ironing therapy（FIT）is
      uncertain after colorectal resection surgery and whether FIT can reduce the incidence of POI
      remains unkonown.
    

Intervention name(s): Foeniculum Vulgare Seed Ironing
Intervention type(s): Drug
Intervention description(s): Stir-fry 500 grams of Foeniculum vulgare seeds until the aroma overflows. Put them into a cotton bag. Ironing therapy put the bag on abdomen after the temperature is suitable, 30 minutes per time, twice daily on postoperative days 2 to 3. The medicine bag can be heated and reused after it cool down.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Colorectal surgery; Foeniculum; Ileus
Wireless Assessment of Respiratory and Circulatory Distress in Chronic Obstructive Pulmonary Disease - Validation Study
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      For patients admitted to the medical ward, it is often difficult to predict if their clinical
      condition will deteriorate, however subtle changes in vital signs are usually present 8 to 24
      hours before a life-threatening event such as respiratory failure leading to ICU admission,
      or unanticipated cardiac arrest. Such adverse trends in clinical observations can be missed,
      misinterpreted or not appreciated as urgent. New continuous and wearable 27/7 clinical vital
      parameter monitoring systems offer a unique possibility to identify clinical deterioration
      before patients condition progress beyond the point-of-no-return, where adverse events are
      inevitable. As part of the WARD-COPD project, this validation study aim to assess the
      accuracy of physiologic parameters derived from standard and wireless patient monitors
    


Intervention name(s): Continuous monitoring system
Intervention type(s): Device
Intervention description(s): Patients recruited will be continuously monitored with Isansys Lifetouch patch, Isansys wireless blood pressure monitor (Meditech Blue BP-05), Nonin WristOx 3150 as well as departments standard monitors
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients admitted to hospital with acute exacerbation of COPD will be included in the study
        upon arrival to the medical ward.
      
Keywords: Continuous monitoring; Wireless monitoring
Expanded Characterization of Immune Response to Merck Adenovirus 5 Gag/Pol/Nef Vaccine Given to HIV Uninfected Adults
Condition: HIV Infections
MeSH terms: Adenoviridae Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to intensively characterize the immune response, particularly
      the T-cell response, to a three-dose regimen of an adenovirus-based HIV-1 vaccine in
      HIV-uninfected adults.
    

Detailed description: 
      This study will look for relationships among the immune responses induced by MRKAd5 HIV-1
      gag/pol/nef vaccine. The study will also determine if the T cells that respond to different
      vaccine epitopes have correspondingly different functional profiles. The study will evaluate
      the safety and tolerability of the vaccine regimen as well.

      This study will last 60 weeks. All enrolled participants will receive vaccinations at Weeks
      0, 4, and 26. There will be between 8 and 20 study visits including the screening visit,
      depending on the site location. A physical exam, interview, and blood collection will occur
      at most or all visits. All participants will undergo leukapheresis approximately 4 weeks
      after their last vaccination and at Week 52. Medical history, an HIV test, a pregnancy test,
      and HIV and risk reduction counseling will occur at selected visits. Additional blood
      collection is now occurring in this study to collect more information about the relationship
      between the immune response and efficacy to the vaccine.
    

Intervention name(s): MRKAd5 HIV-1 gag/pol/nef
Intervention type(s): Biological
Intervention description(s): 1.5x10^10 Ad vg
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV Seronegativity; HIV Preventive Vaccine; Adenovirus
Predicting Oxygen Desaturation in Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: COPD
Study type: Observational

Summary: 
      Oxygen desaturation (SO2 < 88-90%) during walking is a common clinical feature of Chronic
      Obstructive Pulmonary Disease (COPD) patients. By a predicted analysis our study is aimed to
      evaluate anthropometric and functional characteristics of COPD patients correlated with
      oxygen desaturation during Six-minute walking test (6MWT).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        COPD patients
      
Keywords: COPD; Oxygen desaturation; Walking test
Generation of Positive Biological Samples to Epoetin for Doping Control.
Condition: There Are no Conditions Under Study. Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The study consists of generation of biological samples (in blood and urine) positive to
      Epoetin alfa for laboratories that wish to perform the analysis of doping controls and
      maintain accreditation from World Anti-Doping Agency.
    


Intervention name(s): EPOETIN ALFA
Intervention type(s): Drug
Intervention MeSH terms: Epoetin Alfa
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluate the Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females
Condition: Cervical Cancers; Vulvar Cancer; Vaginal Cancer; CIN1; CIN2; CIN 3; AIS; Invasive Carcinoma; Mild Dysplasia of Vulva; Moderate Dysplasia of Vulva; Vin III; VaIN1; VaIN2; VaIN3; Genital Wart
MeSH terms: Condylomata Acuminata; Vulvar Neoplasms; Vaginal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and immunogenicity of the 9-valent Human Papillomavirus (Types 6, 11,
      16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female
      Subjects Aged 9-45 Years.
    


Intervention name(s): 9-valent HPV Recombinant Vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule.; Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Bioavailability Study of Ondansetron 24 mg Orally Disintegrating Tablets Under Fasting Conditions
Condition: Healthy
MeSH terms: Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Single-dose cross over comparative bioavailability of Ondansetron 24 mg oDT and Zofran 24 mg
      ODT
    

Detailed description: 
      To Compare the single-dose bioavailability of Kali's Ondansetron 24 mg ODT with that of
      GlaxoSmithKine's Zofran 24 mg ODT under fasting conditions
    

Intervention name(s): Ondansetron; Zofran
Intervention type(s): Drug; Drug
Intervention description(s): ODT, single-dose, fasting; ODT, single-dose, fasting
Other intervention name(s): Zofran ODT; Ondansetron ODT
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Keywords: bioequivalence; Ondansetron ODT; Fasting; To Determine Bioequivalence Under Fasting Conditions
Clinical Evaluation of Compomer and Composite Class II Restorations in Primary Molars: 24 Months Results
Condition: Primary Teeth
Study type: Interventional

Summary: 
      It was aimed to evaluate the clinical performance of resin-hybrid composite and compomer
      materials in primary molars over a 2-year period.
    

Detailed description: 
      All treatment stages were performed by the same experienced pediatric dentist (E.O.) to avoid
      behavioral problems. When necessary, topical anesthesia with 2% Xylocaine® DENTAL was
      administered, followed by local anesthesia with epinephrine 1: 100.000 (lidocaine HCl and
      Epinephrine Injection, DENTSPLY Pharmaceutical, USA). Access to proximal surfaces was
      provided with high-speed diamond bur (FD.D.801, Frank Dental, Germany) under an air-water
      coolant. The proximal cavity was opened at the occlusal level. Soft carious dentine was
      removed with a round low-speed steel bur (SS.1A, Frank Dental, Germany).

      Restorations were placed under isolation with cotton rolls and a saliva ejector. The Ca(OH)2
      cavity liner material (Hydrocal LC, Medicept Dental, India) was used as base material if the
      distance from the pulp was not safe. A metal matrix band (Matrix band, Hahnenkratt,
      Königsbach-Stein, Germany) was applied to the tooth with a universal matrix system
      (Tofflemire, Hahnenkratt, Königsbach-Stein, Germany) and wooden wedges (TDV, No 1).
      ClearfilTM SE Bond (Kuraray Medical Inc, Okayama, Japan) was applied to the cavity according
      to the manufacturer's instructions. For the polymerization, an LED curing light (Eliapar
      Freelight, 3M ESPE Dental Products, America) was used with a light power density of 600
      mW/cm2. According to the manufacturer's instructions, A2 composite resin (Kerr Herculite
      Classic) and two different compomer materials (Dyract/XP and R&D Series NOVA) were applied to
      the teeth with the incremental technique, and each increment was light-polymerized for 20 sec
      with an LED curing light.
    

Intervention name(s): Dyract XP (Dentsply De Trey), Kerr Herculite Classic (Kerr Corporation),R&D Series NOVA(Kuraray Medical Inc) Clearfil TM SE Bond (Kuraray Medical),Hydrocal LC (Medicept Dental)
Intervention type(s): Other
Intervention description(s): compomer (Dyract XP,R&D Series NOVA) , composite (Kerr Herculite Classic),Bonding (Clearfil TM SE Bond), Dycall (Hydrocal LC)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: class II; compomer; composite resin; primary molars; restoration
Desaturation Validation of INVSENSOR00038
Condition: Healthy
Study type: Interventional

Summary: 
      This study is designed to evaluate the trending accuracy of a noninvasive regional oximetry
      measurement of somatic oxygen saturation. One investigational sensor (INVSENSOR00038) will be
      placed on the somatic site of the volunteer. The values obtained by the test sensor will be
      compared to the reference value obtained from an FDA-cleared sensor placed on the somatic
      site on the contralateral side. Data will be collected from healthy adult subjects while
      undergoing a desaturation procedure wherein the concentration of oxygen inhaled is slowly
      reduced until the subject's oxygen saturation is approximately 70%. The subject will then be
      returned to inhaling room air.
    


Intervention name(s): INVSENSOR00038
Intervention type(s): Device
Intervention description(s): Noninvasive regional oximeter
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Postoperative Sore Throat in Children: Comparison Between Two Supraglottic Devices, Ambu® AuraOnce™ Laryngeal Mask Airway (LMA) and I-Gel®.
Condition: Laryngeal Masks; Pharyngitis; Minors; Anesthesia
MeSH terms: Pharyngitis
Study type: Interventional

Summary: 
      Sore throat is minor but well recognized complaint after receiving general anaesthesia. It is
      rated as 8th most undesirable outcome in postoperative period.It not only affects the
      patient's satisfaction but also can affect patient activities after leaving hospital.

      Many factors can contribute to postoperative sore throat and the incidence has been found to
      vary with the method by which airway is managed.

      The study is conducted to compare the severity and frequency of postoperative sore throat in
      children undergoing elective surgery following the use of AmbuAuraOnce LMA and I-Gel. The
      study will be done in children who are able to self-report the severity of sore throat.

      This study will help us to determine which supraglottic device (I-gel vs. AmbuAuraOnce LMA)
      is better in terms of causing less complication spells of sore throat. The use of such device
      will not only reduce the severity and frequency of postoperative sore throat that may affect
      the activities of patient after leaving hospital but also will improve satisfaction level of
      patient and parents.
    

Detailed description: 
      OBJECTIVE:

      The objective of our study is to assess the frequency and severity of postoperative sore
      throat by comparison between two supraglottic devices, AuraOnce Laryngeal Mask Airway (LMA)
      and I-gel in children undergoing elective lower abdominal or orthopedic surgery.

      HYPOTHESIS: Use of I-gel in children undergoing elective lower abdominal or orthopedic
      surgery is associated with decrease frequency and severity of postoperative sore throat as
      compared to use of AuraOnce Laryngeal Mask Airway.
    

Intervention name(s): I-Gel; LMA
Intervention type(s): Device; Device
Intervention description(s): I-gel is the single use supraglottic airway from intersurgical, UK (Intersurgical Ltd, Wokingham, Berkshire, UK) with an anatomically designed mask made of a gel like thermoplastic elastomer to fit over perilaryngeal and hypopharyngeal structures. It is designed to separate the gastrointestinal and respiratory tracts and also allow a gastric tube to be passed into the stomach.; The AmbuAuraOnce (Ambu A/S, Ballerup, Denmark) is a supraglottic airway device with an inflatable cuff. It is a disposable device as well, but unlike I-gel, it does not feature a gastric channel.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Adipokines Effect in Myometrial Contractility
Condition: Myometrium; Contractility; GDM; Obesity
Study type: Observational

Summary: 
      Investigate the effect of two adipokines which are adiponectin and TNFa on the force of
      myometrial contractility in diabetic, non-obese pregnant women and obese, non-diabetic term
      pregnant women at the time of scheduled cesarean delivery
    


Intervention name(s): Adiponectin and TNFa
Intervention type(s): Biological
Intervention description(s): Adiponectin and TNFa are adipokines. Will be added to the myometrial biopsies to investigate their effect on the force of contractility
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant subjects undergoing a scheduled C-section delivery.
Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion
Condition: Degenerative Disc Disease; Degenerative Spondylolisthesis; Spinal Stenosis
MeSH terms: Spinal Stenosis; Intervertebral Disc Degeneration; Spondylolisthesis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and preliminary efficacy of NeoFuse in
      subjects with a diagnosis of degenerative disc disease (DDD) in 1 or 2 adjacent vertebral
      levels between L1 and S1. All subjects in this study will undergo interbody fusion via
      Transforaminal Lumbar Interbody Fusion (TLIF) or Posterior Lumbar Interbody Fusion (PLIF)
      procedures with Food and Drug Administration (FDA) approved/cleared supplemental posterior
      instrumentation.
    

Detailed description: 
      This is a prospective, multicenter, randomized, open-label controlled Phase 2 study designed
      to evaluate the safety and preliminary efficacy of adult, allogeneic mesenchymal precursor
      cells (MPCs) combined with MasterGraft Matrix when compared to use of autologous iliac crest
      bone graft in the lumbar interbody fusion site in subjects requiring 1 or 2 level interbody
      fusion procedure with instrumentation. All subjects in this study will undergo a 1 or 2-level
      (2 or 3 vertebrae) interbody fusion with supplemental posterior instrumentation.

      After the screening and surgical visits, each subject will be evaluated clinically and
      radiographically within 3 days and 30 days after surgery, and at 3, 6, 9, 12, 24, and 36
      months after surgery.

      Subjects will be evaluated at the same time points for safety.
    

Intervention name(s): Lumbar Interbody Fusion with Autograft; Lumbar Interbody Fusion with NeoFuse; Lumbar Interbody Fusion with NeoFuse
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Single Dose Autograft Surgical Implantation; Single Dose NeoFuse Surgical Implantation; Single Dose NeoFuse Surgical Implantation
Other intervention name(s): Spinal Fusion; Control; Spinal Fusion; Stem Cells; Spinal Fusion; Stem Cells
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Degenerative disc disease; Spondylolisthesis; Spinal stenosis; Stem cells; Adult Stem Cells; Spinal Fusion; Lumbar Spinal Fusion; TLIF; PLIF; Mesoblast
Comparison of the Efficacy of Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) and Norfloxacin in Secondary Prophylaxis for Spontaneous Bacterial Peritonitis
Condition: Spontaneous Bacterial Peritonitis
MeSH terms: Peritonitis
Study type: Interventional

Summary: 
      -Consecutive patients of decompensated cirrhosis of any etiology, presenting to the Institute
      of Liver and Biliary Sciences hospital with spontaneous bacterial peritonitis will be
      evaluated
    


Intervention name(s): GMCSF; Norfloxacin
Intervention type(s): Drug; Drug
Intervention description(s): GMCSF 1.5mcg/Kg; Tablet Norfloxacin 400 mg
Intervention MeSH terms: Norfloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Repeatability and Reproducibility of Skin Test Endpoint Titration
Condition: Allergic Reaction
MeSH terms: Hypersensitivity
Study type: Observational

Summary: 
      This study will examine the within-tester repeatability and between-tester reproducibility of
      skin test endpoint titrations performed in those with allergic sensitivities.
    

Detailed description: 
      Participants will be recruited from the local community. Participants with a previous history
      of skin prick testing in our lab will not be required to undergo preliminary skin prick
      testing, as the allergen to be used for skin prick titrations is known. New participants will
      undergo skin prick testing. The procedures for skin prick testing and skin test endpoint
      (STE) titration will be guided by the AllerGen CIC Allergen Skin Titration by Epicutaneous
      Method (Prick) Standard Operating Procedure. Different allergen extracts for the skin prick
      test or different doubling doses of an allergen in duplicate for the STE will be applied to
      the forearm, pricked with a lancet, and assessed ten minutes later by measuring the wheal
      sizes produced. The study will require three visits to the lab (i.e. three testers), each
      separated by one week and lasting roughly 30 minutes. Each visit will entail the duplicate
      STE procedure performed by a different tester. If a participant is new to the lab, they will
      undergo skin prick testing during their first lab visit prior to undergoing the skin prick
      titration and so, their first study visit may last up to one hour.
    

Intervention name(s): Skin test endpoint titration
Intervention type(s): Procedure
Intervention description(s): An allergen that is suitable to cause skin reactions when introduced to the forearm through pricking will be administered in doubling concentrations.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will be recruited from the local community.
      
Keywords: skin test endpoint
Hypopressive Effectiveness in Postural Control and Pelvic Floor.
Condition: Pelvic Floor Disorders; Postural; Defect; Muscle Weakness
MeSH terms: Muscle Weakness; Pelvic Floor Disorders
Study type: Interventional

Summary: 
      Effects of an exercise program based on hypopressive exercises in the female population.
    

Detailed description: 
      Participants allocated to the intervention group completed 10 weeks of hypopressive exercises
      training with a frequency of two sessions of 30 minutes twice a week.
    

Intervention name(s): Hypopressive exercises
Intervention type(s): Other
Intervention description(s): The first two sessions will have as objective the correct and effective learning of the hypopressive technique. The rest of the sessions will be dedicated to the realization of an exercise protocol based on a progression of postures from standing to supine. Diaphragmatic apneas of approximately 7 seconds will be performed, alternating each apnea with three breaths.
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: This study was a single-blinded randomized controlled trial
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Assess Adverse Events and Compare How Crushed, Ground, and Intact Oral Tablets Venetoclax Moves Through the Body of Healthy Female Adult Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to assess the oral bioavailability of crushed and ground
      venetoclax commercial tablets relative to the intact venetoclax commercial tablets under fed
      condition in healthy female participants.
    


Intervention name(s): Venetoclax
Intervention type(s): Drug
Intervention description(s): Oral; Tablet
Other intervention name(s): ABT-199; Venclaxta
Intervention MeSH terms: Venetoclax
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteers; Venetoclax; ABT-199