bioihbjkbjnl/mcl2 huggingface dataset:
To Demonstrate the Relative Bioavailability of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fasted Conditions
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioavailability of Geneva and Basel (Anafranil) 25 mg
      Clomipramine Hydrochloride capsules under fasted conditions.
    


Intervention name(s): Clomipramine Hydrochloride 25 mg Capsules (Geneva Pharmaceuticals); Anafranil Clomipramine Hydrochloride 25 mg Capsules (Basel)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Clomipramine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antidepressant
Retrospective Review of Gastrointestinal System Endoscopy Procedures
Condition: Endoscopy; Colonoscopy; Gastroscopy; Colonic Polyps; Endoscopy, Digestive System; Gastrointestinal Neoplasms; Biopsy
MeSH terms: Gastrointestinal Neoplasms; Digestive System Neoplasms; Colonic Polyps
Study type: Observational

Summary: 
      The aim of the study is retrospectively evaluating all features of endoscopic and
      pathological diagnoses of cases who underwent upper and lower gastrointestinal endoscopy.
    

Detailed description: 
      Gastrointestinal system endoscopy has an important place in the diagnosis and treatment of
      many diseases related to this system and provides an alternative to current surgical methods
      with its ever-expanding field of application. Upper and lower gastrointestinal endoscopy
      procedures are performed with many indications, such as new complaints in the
      gastrointestinal tract at the age of 50 and over, family history of gastrointestinal
      malignancy. In addition, the importance of endoscopy is gradually increasing as tissue and
      cell samples can be taken for histopathological studies and endoscopic treatment of some
      diseases.

      The aim of the study is to review patients' indications, distribution by age and gender,
      frequency of lesions diagnosed on endoscopy, prevalence, size, histology and location of
      polyps detected and excised, results of endoscopic and pathological diagnoses.

      The study population consists of the patients who were examined at the Istanbul Sultanbeyli
      State Hospital Endoscopy Unit between 01.01.2016 and 01.01.2021.

      The patients' data will be scanned retrospectively by accessing their files from the computer
      database.
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study population consists of the patients who were examined at the Istanbul Sultanbeyli
        State Hospital Endoscopy Unit between 01.01.2016 and 01.01.2021.
NECTAR Study: Nectar (Honey) Effects on Comfort, Thoughts, and Regularity
Condition: Gastrointestinal Dysfunction; Physiological Stress; Cognition - Other
Study type: Interventional

Summary: 
      This study aims to test the central hypothesis that adding to the diet daily yogurt with
      honey provides beneficial effects on digestive health and subjective mood in healthy adults.
    

Detailed description: 
      This clinical trial will be a randomized, controlled, double-blind, crossover study with two
      2-week treatment conditions separated by at least a 4-week washout period between conditions.
      Participant flow through the study conditions will be counterbalanced. Participants will be
      randomly allocated to yogurt with honey first or control first. Before beginning the first
      intervention period, participants will undergo a 2-week lead-in period that is devoid of all
      supplemental and dietary probiotics, fermented dairy products, and fermented foods.
      Participants will be asked to refrain from consuming all supplemental and dietary probiotics,
      fermented dairy products, and fermented foods throughout the entire study.
    

Intervention name(s): Yogurt with B. lactis and added honey; Yogurt with heat-inactivated B. lactis and added cane sugar
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The intervention condition will utilize a commercially available yogurt (Activia) that contains Bifidobacterium animalis lactis DN-173 010/CNCM I-2494 (B. lactis). Participants will consume 170 g of yogurt with honey twice daily for 14 days.; The control condition will utilize a commercially available yogurt (Activia) following heat inactivation of the probiotic Bifidobacterium animalis lactis DN-173 010/CNCM I-2494 (B. lactis). Participants will consume 170 g of the heat-inactivated yogurt with added cane sugar twice daily for 14 days.The added cane sugar will be an isocaloric amount to the honey.
Other intervention name(s): Treatment; Control
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, controlled, single-blind, crossover study with two 2-week treatment conditions separated by at least a 4-week washout period between conditions. Participant flow through the study conditions will be counterbalanced. Participants will be randomly allocated to yogurt with honey first or control first.
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: gastrointestinal transit time, mood, emotion
Information for Patient Controlled Analgesia Device
Condition: Postoperative Care; Hysterectomy; Health Communication
Study type: Interventional

Summary: 
      This study is aimed to show the effect of information method on properly usage of the patient
      controlled analgesia(PCA) device
    

Detailed description: 
      Postoperative pain is still a challenge for anesthesiologist. Patient controlled analgesia is
      an effective method for postoperative pain management. However, most of the patient can not
      use the device properly. The important cause of inabilities about device usage is
      insufficient information.In the patient information, visual, oral or written communication
      methods can be chosen. However, which method is suitable for our patient group is not
      clear.This study is aimed to show the effect of information method on properly usage of the
      patient controlled analgesia(PCA) device
    

Intervention name(s): written form; video; routine care
Intervention type(s): Other; Other; Other
Intervention description(s): The written form which include PCA usage information.; The video about PCA usage; The routine description about PCA usage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Exhaled Breath Condensate (EBC) Assessment in Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      This study aimed to assess airway inflammation in patients during the course of acute
      exacerbations of chronic obstructive pulmonary disease (AECOPD) by serial analyses of their
      exhaled breath condensates (EBC).
    

Detailed description: 
      Subject recruitment

      Patients who had been admitted to the Prince of Wales Hospital with AECOPD were recruited for
      this study. Subjects with pneumonic changes on the chest radiographs were excluded. Age and
      sex-matched COPD subjects at stable state (without AECOPD for at least 10 weeks) and healthy,
      non-smoking subjects were recruited as controls.

      Collection of exhaled breath condensate (EBC) EBC was collected using the EcoScreen (VIASYS
      Healthcare, Conshohochen, PA, USA) according to the manufacturer's instructions. EBC was
      stored in 250 microL aliquots immediately at -70oC until analysis. EBC was collected on Day
      5, 14, 30 and 60 after hospitalization for subjects with AECOPD. For the stable COPD patients
      and normal controls, EBC collection was performed once.

      Measurement of TNF alpha, LTB4 and IL-8 The concentrations of TNF alpha, LTB4, and IL-8 in
      EBC were measured in one batch by high-sensitivity sandwich enzyme immunoassays (TNF alpha
      and IL-8 from BioSource International, Camarillo, CA, USA; LTB4 from Cayman Chemical Company,
      Ann Arbor, MI, USA) according to the manufacturers' instructions. Intra-subject repeatability
      of TNF alpha, LTB4 and IL-8 was assessed by collection of EBC in stable COPD subjects. EBC
      was collected as described above at the same time (09:00 to 10:00) on 2 consecutive days.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        COPD patients with exacerbations Stable COPD patients Normal subjects
      
Biospecimen description: 
      Exhaled breath condensate
    
Keywords: COPD; exhaled breath condenate; Exhaled breath condenate, acute exacerbation of COPD
Iressa Follow-up Trial
Condition: Lung Cancer; Breast Cancer
MeSH terms: Breast Neoplasms; Lung Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the long-term safety profile and the secondary
      objective to estimate clinical benefit of ZD1839 (gefitinib).
    


Intervention name(s): Gefitinib
Intervention type(s): Drug
Intervention description(s): ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
Intervention MeSH terms: Gefitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lung cancer; breast cancer
Radiation Stent Versus Self-expanding Metallic Stents (SEMS) for Palliative Treatment of Malignant Biliary Stricture
Condition: Cholangiocellular Carcinoma; Pancreatic Cancer; Gallbladder Cancer; Metastatic Carcinoma
MeSH terms: Carcinoma; Gallbladder Neoplasms; Cholangiocarcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      Malignant biliary obstruction is a common clinical condition caused by various malignancies.
      Currently,biliary stent implantation guided either by fluoroscopy or endoscopy has become the
      most important methods for relieving malignant biliary obstruction. However, the benefit for
      the survival of the patients with palliation of the stent treatment is limited because no
      therapeutic effects on process of the tumor itself by a stent implantation. Encouraged by the
      success of 125I esophageal stent in esophageal carcinoma, a novel biliary stent loaded with
      125I radioactive seeds has been developed in our institute. After ex vivo and in vivo
      evaluations for the delivery system, the investigators prospectively compare the responses to
      treatment with this radiation biliary stent, versus the conventional biliary SEMS in patient
      with malignant biliary obstruction.
    


Intervention name(s): self-expandable 125I radioactive seeds-loaded-stent; self-expandable biliary nitinol alloys stent
Intervention type(s): Device; Device
Intervention description(s): Patients undergo placement of a self-expandable 125I radioactive seeds-loaded-stent on day 1.; Patients undergo placement of a conventional self-expandable biliary nitinol alloys stent on day 1.
Other intervention name(s): irradiation biliary stent; conventional SEMS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study to Assess the Pharmacokinetics, Safety and Tolerability of Baloxavir Marboxil in Healthy Chinese Participants
Condition: Healthy Volunteer
Study type: Interventional

Summary: 
      This study will evaluate the pharmacokinetics, safety and tolerability of a single oral dose
      of baloxavir marboxil (40 mg or 80 mg) in healthy Chinese participants.
    


Intervention name(s): Baloxavir Marboxil
Intervention type(s): Drug
Intervention description(s): Participants will receive either 40 mg or 80 mg of baloxavir marboxil on Day 1 as a single oral dose.
Other intervention name(s): Xofluza
Intervention MeSH terms: Baloxavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
The Effects of a Ficus Carica in Subjects With Functional Constipation
Condition: Functional Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The investigators performed a 8-week, randomized, double-blind, placebo-controlled human
      trial to evaluate the efficacy and safety of Fig paste on functional constipation. The
      investigators measured colon transit time, frequency of defecation, defecation time, stool
      type, and abdominal discomfort.
    


Intervention name(s): Ficus Carica (300g/day); Placebo (300g/day)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Ficus Carica (300g/day), parallel design; Placebo (300g/day), parallel design
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Effect of Chrysanthemum Flower Oil and Its Dose-dependency on Hyperuricemia
Condition: Hyperuricemia
MeSH terms: Hyperuricemia
Study type: Interventional

Summary: 
      The aim of this study is to investigate the efficacy and dose-dependency of chrysanthemum
      flower oil in suppressing serum uric acid.
    


Intervention name(s): 200 mg of chrysanthemum flower oil; 300 mg of chrysanthemum flower oil; 400 mg of chrysanthemum flower oil
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Abdominal Wall Closure With Triclosan-coated Suture
Condition: Infection
MeSH terms: Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      After open colorectal surgery the surgical site infection (SSI) is very high among abdominal
      surgeries. The goal of the investigators randomized, prospective, multicentric,
      internet-based study is to compare rate of SSI after surgery of colon and rectum by using
      triclosan-coated suture for abdominal wall closure. 180-180 cases in seven centres are
      involved in this study. Two arms are separated by computer randomization at abdominal wall
      closure: application of triclosan-coated and non-coated PDS suture (PDS versus PDS-Plus).
      Triclosan is an antiseptic material which the investigators hope will provide better local
      infection control at the site with reducing the risk of bacterial colonisation.
    

Detailed description: 
      After open colorectal surgery the surgical site infection (SSI) is very high among abdominal
      surgeries. The goal of our randomized, prospective, multicentric, internet-based study is to
      compare rate of SSI after surgery of colon and rectum by using triclosan-coated suture for
      abdominal wall closure. Two arms are separated by computer randomization at abdominal wall
      closure: application of triclosan-coated and non-coated PDS suture (PDS versus PDS-Plus).
      Triclosan is an antiseptic material which we hope provides better local infection control at
      the site with reducing the risk of bacterial colonisation.

      attached website: www.itplan.hu/sebstudy/ Randomizing patients: 1. logging in (completing the
      ID panel) 2. on-line randomization 3. patient appears on list 4. operation (recording
      details) 5. recording - post-operation events

        -  complications

        -  control examination
    

Intervention name(s): abdominal wall closure; surgical site infection
Intervention type(s): Procedure; Procedure
Intervention description(s): triclosan-coated (PDS-Plus) and non-coated (PDS) suture to close the abd. wall; triclosan-coated (PDS-Plus) and non-coated (PDS) suture to close the abd. wall
Other intervention name(s): presence of surgical site infection; level of surgical site infection; presence of surgical site infection; level of surgical site infection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: surgical site infection; elective colorectal surgery; level of surgical site infection; complication of surgical site infection; type of changed bandage; frequency of bandage changing
Statin Adjunctive Therapy for TB
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 2

Summary: 
      There is an urgent need for novel therapies to shorten TB treatment and improve long-term
      lung function outcomes. Host-directed therapies (HDT) have received significant attention
      recently given the ability of M. tuberculosis to subvert host immune responses and cause
      destructive lung pathology. Statins are among the most promising HDT agents for TB. In
      addition to having a highly favorable safety profile, statins have been shown to have anti-TB
      activity in macrophages, to synergize with anti-TB drugs, and to shorten the duration of TB
      treatment in the standard mouse model.

      The StAT-TB trial will comprise two different stages. In the 14-day Stage 1 study,
      investigators will test the safety and tolerability, as well as Pharmacokinetics (PK), of two
      different doses of pravastatin co-administered with standard anti-TB treatment. In Stage 2,
      investigators will test the ability of pravastatin adjunctive therapy (dose to be determined
      in Stage 1) to shorten the mean time to sputum culture conversion (primary endpoint) and
      improve lung function outcomes (secondary endpoints) relative to the standard regimen. In
      addition, investigators will continue to investigate the anti-TB mechanism of action of
      pravastatin in order to further improve HDT options for TB in the future.
    


Intervention name(s): Pravastatin
Intervention type(s): Drug
Intervention description(s): Phase IIB clinical trial: A two-week safety/PK study to determine pravastatin exposures over 24 hours when given together with first-line treatment (HRZE) and ensure the combination is safe and well-tolerated.
A two-week safety/PK study to determine pravastatin exposures over 24 hours when given together with first-line treatment (HRZE) and ensure the combination is safe and well-tolerated.
Intervention MeSH terms: Pravastatin
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
(YMP) Young Moms Program
Condition: Chronic Toxic Stress; Developmental/ Behavioral Regression in Young Children
Study type: Interventional

Summary: 
      Young Moms Program (YMP) is designed to address systemic barriers to the health and stability
      of young moms and their children such as the lack of coordination of service delivery or
      logistical barriers within the health system. The YMP also streamlines the referral pipeline,
      connecting moms to evidence-based resources, and ensuring children complete all recommended
      assessments prior to kindergarten.
    

Detailed description: 
      This application is a community-engaged research collaboration between the non-profit
      Imprints Cares, the Wake Forest Baptist Medical Center (WFBMC) Birth Center, and Wake Forest
      School of Medicine (WFSOM). This project addresses the myriad risks associated with young
      moms ≤ 21 years old. Because YMP is a tiered program model, services meet parents where they
      are through a "warm hand-off" approach that uses one-on-one consultation and assessment-based
      interventions.
    

Intervention name(s): "traditional" Parents as Teachers (PAT); "hybrid" PAT model
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A twice-a-month home visits from trained family educators. Home visits will continue for the remainder of the study period as will the other components of the Parents as Teachers model: regular Group Connections for peer interactions and support, age-appropriate health and developmental screenings, and referrals that reflect mother and infant needs to community agencies that include the Child Development Services Agency (which provides screening for Individuals with Disabilities in Education Act (IDEA) Part C services), family services, intensive mental health services, among others.; A six-week virtual evidence-based parenting class entitled What You Do Matters, which will be delivered in partnership with the Pediatric Advocacy Program at WFBMC which combines short parent-educator discussions followed by interactive activities and peer to peer networking.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study team will employ a blind randomized design to assign individuals to either the "traditional" Parents as Teachers (PAT) or the "hybrid" PAT model.
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: young moms; child health; teen births; child maltreatment; food insecurity
Social Media, Smartphone Use and Self-harm in Young People
Condition: Self-Harm, Deliberate
MeSH terms: Self-Injurious Behavior
Study type: Observational

Summary: 
      Self-harm is when somebody hurts their body as a way of coping with difficult feelings.
      Self-harm is becoming increasingly common in young people, particularly in adolescent
      females. The rise in self-harm has been linked to increasing use of social media and internet
      technology among young people. However, the evidence is limited to associations with poorer
      mental health outcomes rather than identifying particular aspects of using these technologies
      that can negatively impact on mental health.

      This study aims to investigate how the use of social media and a smartphone may increase the
      risk of self-harm in young people by exploring changes in usage in the period leading up to
      an episode of self-harm. The information from this study will allow us to understand whether
      there are certain behaviours that are more likely to occur before an episode of self-harm.
      This will inform new strategies to identify and provide support to vulnerable young people.
      For example, linking young people with crisis support or empowering young people to make
      changes, manage their own risks and build resilience.

      This study will recruit young people aged 13-25 years old who have accessed mental health
      services provided by an NHS Trust in South-East London. Young people will be invited to
      provide information on their mental health and social media and smartphone use over a period
      of six months.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Clinical sample
      
Keywords: Young adult; Adolescent; Social media; Smartphone; Mental health
Safety and Efficacy Study of XPF-001 to Treat Pain Following Wisdom Tooth Extraction
Condition: Dental Pain
MeSH terms: Toothache
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to determine if XPF-001 is effective for the treatment of pain
      following third-molar/wisdom tooth extraction.
    


Intervention name(s): XPF-001; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single oral administration of 500 mg XPF-001 capsules (5 x 100 mg capsules); Single oral administration of 5 x 100 mg Placebo capsules.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain following 3rd molar/wisdom tooth extraction