bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics of Jaktinib in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study was to assess the effect of rifampicin and itraconazole,
      on the pharmacokinetics (PK) of Jaktinib in healthy Volunteers.
    


Intervention name(s): Jaktinib Hydrochloride Tablets; Itraconazole capsule; Rifampicin Capsules
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral Jaktinib 100 mg for 1 day; Oral Itraconazole 200 mg for 9 day; Oral Rifampicin 600 mg for 11 day
Other intervention name(s): Jaktinib; Itraconazole; Rifampicin
Intervention MeSH terms: Itraconazole; Hydroxyitraconazole; Rifampin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trial Comparing Early Complications of Two Techniques in the Laparoscopic Gastric Bypass
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to define and evaluate the early complications between two
      different surgical techniques used to perform a laparoscopic gastric bypass
    


Intervention name(s): Laparoscopic Gastric Bypass; Laparoscopic Gastric Bypass
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Early Complications of both techniques; Fistula rate; Dehiscence rate; reoperation rate and cause
Effect of Tub Bathing on Skin and Bilirubin Levels in Infants Undergoing Tunnel and LED of Phototherapy
Condition: Newborn Jaundice
MeSH terms: Jaundice, Neonatal; Jaundice
Study type: Interventional

Summary: 
      The study was conducted as a randomized controlled study to determine effect of tube bathing
      on skin and bilirubin levels in infants undergoing tunnel and LED of phototherapy. The
      population of the study consisted of term babies with the diagnosis of hyperbilirubinemia in
      Gaziantep Cengiz Gökçek Maternity and Pediatrics Hospital and Kilis State Hospital Neonatal
      Intensive Care Units (NICU) among November 2019-September 2020. The sample size was composed
      of a total of 140 babies, which were determined according to Power Analysis and met the case
      selection criteria. Accordingly, Thirty-five babies were randomly assigned to each group
      (Tunnel Group = experiment and control; LED Group = experiment and control). The babies in
      the experimental groups were given a tube bath at 6 and 12 hours after phototherapy started.
      On the other hand, the babies in the control groups were given routine cares in the units.
      Data were gathered 'Information and Registration Form', Neonatal Skin Risk Assessment Scale
      (NSRAS) and Neonatal Skin Condition Score (NSCS).
    


Intervention name(s): TUBE BATH
Intervention type(s): Other
Intervention description(s): Wrap Tube Baht (immersion)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: tube bath; skin care; phototherapy
Safety and Efficacy of TJ301 IV in Participants With Active Ulcerative Colitis
Condition: Active Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, randomized, double-blind, placebo-controlled phase II study.
    

Detailed description: 
      is a multicenter, randomized, double-blind, placebo-controlled phase II study. The trial
      includes a Run-in Period (if stable conventional treatment needed), a 4-week Screening
      Period, a 12-week Treatment Period, and a 3-week Safety Follow-up Period to Day 105.

      90 patients will be centrally, dynamically, randomly assigned to 3 groups (1:1:1) to receive
      600mg TJ301 Q2W, 300mg TJ301 Q2W or placebo Q2W.
    

Intervention name(s): TJ301 300mg; TJ301 600mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TJ301 300mg IV infusion; TJ301 600mg IV infusion; Placebo IV infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Double-blind, Placebo-controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Randomized; Double-blind; Placebo-controlled; Safety; Efficacy; Active Ulcerative Colitis
This Study is Done in Healthy Japanese Volunteers. It Looks at How Different Doses of BI 1015550 Are Taken up in the Body and How Well They Are Tolerated.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the safety and tolerability of BI
      1015550 in healthy male subjects following oral administration of single rising doses.

      Secondary objectives are the exploration of the pharmacokinetics (PK) including dose
      proportionality of BI 1015550 after single dosing.
    


Intervention name(s): BI 1015550; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single rising oral dose; Single rising oral dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Outcome of Ahmed Glaucoma Valve in Difficult Glaucoma Cases
Condition: Glaucoma, Open-Angle; Glaucoma Secondary; Glaucoma, Neovascular
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Glaucoma, Neovascular
Study type: Interventional

Summary: 
      The clinical difference (mean IOP, success rate, and complications) on using S2 and FP7
      models of Ahmed Glaucoma Valve that had similar dimensions and different materials used for
      their construction in one year follow up was evaluated.
    

Detailed description: 
      Refractory glaucoma is a difficult subject; many glaucoma devices are tried to reduce IOP.
      Glaucoma devices is now an integral part of glaucoma surgery. AGV is commonly used. The
      investigators need to compare the efficiency and failure rate of two models of AGV. The point
      that is the biological reaction around capsule can affect the efficiency.
    

Intervention name(s): Ahmed Glaucoma Valve surgery
Intervention type(s): Procedure
Intervention description(s): The surgical procedure was identical for both implant types and was performed as described previously.9,14 All surgical procedures were performed under local anesthesia except for children, general anesthesia was used. The valve plate was primed and placed in the superotemporal quadrant after making fornix-based conjunctival flap. The valve plate was secured to sclera with 10-0 nylon sutures 10 mm posterior to the limbus. Before implantation, applying sponges soaked with Mitomycin- c 0.3 cc for three minutes on bare sclera at this quadrant. The tube was placed in the anterior chamber through a 23-gauge needle tract at the limbus. The tube left patent and viscoelastic substance injected into anterior chamber. A donor scleral graft was secured with interrupted 10-0 nylon sutures over the exposed portion of the tube. Conjunctiva was sutured with 10-0 nylon sutures.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: comparing clinical outcome variables (IOP, number of glaucoma medications, visual acuity, and complications) after using S2 and FP7 models of Ahmed Glaucoma Valves.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: glaucoma-ahmed-valve-S2-FP7-IOP-encapsulation
Metabonomic of Patients With Hepatitis B Cirrhosis Complicated With Sarcopenia.
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Observational

Summary: 
      Sarcopenia is a common complication in liver cirrhosis patients and has been confirmed that
      associated with poor prognosis. China has the world's largest burden of hepatitis B
      virus-related liver cirrhosis (HBV-related liver cirrhosis). However, the relationship
      between HBV-related liver cirrhosis patients with muscle mass loss and normal muscle mass is
      remain largely unknown. Our study aimed to reveal the metabolic profile and identify
      potential biomarkers of muscle mass loss in HBV-related liver cirrhosis.
    


Intervention name(s): CT at the level of the third lumbar vertebra (L3)
Intervention type(s): Diagnostic Test
Intervention description(s): Muscle mass loss was defined as an skeletal muscle mass index (SMI) less than 46.96 cm²/m² for males and less than 32.46 cm²/m² for females
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with HBV-related liver cirrhosis were recruited between August 2021 and June 2022
        at the Affiliated hospital of Qingdao University. All of the patients are in the
        decompensation stage of hepatitis B cirrhosis and divided them into two groups. One group
        is named cirrhosis with muscle mass loss, the other group is named liver cirrhosis with
        normal muscle mass. People in healthy control group were excluded metabolic diseases. Each
        group of patients is about 20.
      
Keywords: Hepatitis B virus-related liver cirrhosis; muscle mass loss; metabolites
Comparing Praziquantel Versus Artesunate + Sulfamethoxypyrazine/Pyrimethamine for Treating Schistosomiasis
Condition: Schistosoma Haematobium
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy of praziquantel versus As+SMP
      (Co-Arinate FDC ®) in the treatment of Schistosoma haematobium in 6-15 year old Malian
      children. The nul-hypothesis in this study is that the combination of As+SMP is more
      effective than praziquantel in the treatment of S. haematobium infected children.
    


Intervention name(s): Artesunate+Sulfamethoxypyrazine/pyrimethamin; Praziquantel
Intervention type(s): Drug; Drug
Other intervention name(s): Co-Arinate FDC ®
Intervention MeSH terms: Artesunate; Sulfalene; Praziquantel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Schistosoma haematobium; Praziquantel; Artesunate + Sulfamethoxypyrazine/pyrimethamine; Randomized double blind placebo controlled clinical trial
Effect of Glycemic Index on Physical Capacity in Runners
Condition: Nutrition; Sport; Glycemic Index; Physical Capacity
Study type: Interventional

Summary: 
      The purpose of the present study was to assess the influence of low vs moderate glycemic
      index of a 3-week diet on aerobic capacity, endurance performance and body mass and
      composition in endurance-trained athletes in a randomized, controlled crossover trial.
    

Detailed description: 
      The effect of glycemic index of pre-exercise meal on endurance capacity and performance has
      been widely investigated. However, little is known about the adaptations to longer dietary
      interventions with different glycemic index and their influence on aerobic capacity and body
      composition in runners. Therefore, the purpose of this study was the assessment of the
      influence of low GI vs moderate GI of a 3-week diet on aerobic capacity, endurance
      performance and body mass and composition in endurance-trained athletes in a randomised,
      controlled crossover trial.
    

Intervention name(s): Dietary Intervention: Low vs. moderate glycemic index
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Nutrition; Training support; Low Glycemic Index; Moderate Glycemic Index; Endurance; Running
A Study to (1) Compare How BI 456906 is Taken up in the Body of Healthy People and People With Liver Problems and (2) Find Out How People With Overweight and Obesity, With and Without Liver Problems, Tolerate Different Doses of BI 456906
Condition: Healthy; Liver Diseases; Obesity
MeSH terms: Liver Diseases; Obesity; Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is open to adults who have different levels of liver problems and adults who are
      healthy. People with or without overweight or obesity can take part.

      This study has 2 parts. The purpose of Part 1 is to find out whether having liver problems
      influences how BI 456906 is taken up in the body. The purpose of Part 2 is to find out
      whether having liver problems influences how people with overweight and obesity tolerate
      different doses of BI 456906.

      In Part 1, participants get a single injection of BI 456906 under their skin and stay at the
      study site for 2 nights afterwards. They are in the study for about a month. During this
      time, they visit the study site about 8 more times. The doctors compare the amount of BI
      456906 in the blood of healthy people and people with liver problems.

      In Part 2, participants get 1 or 2 injections of BI 456906 once a week under their skin for
      28 weeks. At the beginning, they get lower doses of BI 456906. Over time, they get higher
      doses until they reach a certain dose of BI 456906. This dose is then maintained until the
      end of the treatment. Participants in Part 2 are in the study for about 7 months. During this
      time, they visit the study site about 16 times and get about 15 phone calls from the site
      staff. The doctors record the number of people with health problems that could have been
      caused by treatment with BI 456906. They compare the results between participants with liver
      problems and those without liver problems.

      In both parts, doctors also regularly check participants' health and take note of any
      unwanted effects.
    


Intervention name(s): BI 456906
Intervention type(s): Drug
Intervention description(s): BI 456906
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Efficacy and Safety of Dasotraline in Children 6 to 12 Years of Age With Attention-Deficit Hyperactivity Disorder (ADHD) in a Simulated Classroom Setting.
Condition: Attention-Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to evaluate the efficacy and safety of dasotraline in children 6 years of age to 12
      years of age with Attention-Deficit Hyperactivity Disorder (ADHD) in a simulated classroom
      setting.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety
      study in children with ADHD in a laboratory classroom setting. The study will be comprised of
      3 periods: Screening (up to 35 days) including a 3 - 5 day ADHD medication washout prior to
      Day -1; Double-blind randomized treatment with either dasotraline (4 mg/day) or placebo for14
      days; and End of Study (EOS) Visit (7 days after last dose). Prior to the start of treatment
      (Day 1) and following the conclusion of the double-blind period (Day 15), subjects will
      undergo a full-day laboratory classroom evaluation during which approximately 12 to 18
      subjects will be assessed. Each laboratory classroom day will include seven 30-minute
      simulated classroom sessions where trained observers will assess subjects using the Swanson,
      Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Scale. In addition during each classroom session,
      a 10-minute math test (Permanent Product Measure of Performance [PERMP]) will be administered
      to evaluate sustained attention and effort. Seven (± 2) days after the last dose of study
      drug, subjects will return to the clinic and complete safety assessments.
    

Intervention name(s): dasotraline 4mg; Placebo
Intervention type(s): Drug; Other
Intervention description(s): dasotraline 4mg/day; placebo/day
Other intervention name(s): SEP-225289; Placebo comparitor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Attention-Deficit Hyperactivity Disorder (ADHD)
Pan-intestinal Capsule Endoscopy Versus Colonoscopy in Iron Deficiency Anemia or Overt GI Bleeding
Condition: Iron Deficiency Anemia; GastroIntestinal Bleeding
MeSH terms: Gastrointestinal Hemorrhage; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases; Hemorrhage
Study type: Interventional

Summary: 
      The authors hypothesize that in patients with iron deficiency anemia or gastrointestinal
      bleeding, pan-intestinal capsule endoscopy is a safe and well tolerated procedure that may
      improve diagnostic yield comparatively to the current standard invasive colonoscopy.
    

Detailed description: 
      Patients presenting with iron deficiency anemia (IDA) or overt GI bleeding are often
      submitted to conventional upper GI endoscopy and colonoscopy, followed by small bowel capsule
      endoscopy if diagnosis remains elusive. Recently, however, the possibility of performing
      pan-intestinal endoscopy using a video capsule that evaluates both the small bowel and the
      colon in a single non-invasive examination, opens new perspectives for the management of
      those conditions, particularly when the initial upper GI endoscopy has been non-diagnostic.
      The authors hypothesize that performing early pan-intestinal capsule endoscopy strategy may
      allow, in a safe and well tolerated manner, to identify which patients would benefit of
      further interventions, such as colonoscopy or invasive enteroscopy, guided by findings
      pre-identified at capsule examination. The study aims to evaluate whether pan-intestinal
      capsule endoscopy is superior to the current standard strategy of conventional colonoscopy
      after non-diagnostic upper endoscopy in patients with IDA or overt GI bleeding, regarding
      diagnostic yield, safety and tolerability.
    

Intervention name(s): Pan-intestinal capsule endoscopy
Intervention type(s): Diagnostic Test
Intervention description(s): Patients with iron deficiency anemia or overt GI bleeding with non-diagnostic upper GI endoscopy will be submitted to same-day pan-intestinal capsule endoscopy using PillCam Crohn's Capsule (Medtronic) followed by conventional colonoscopy under propofol sedation
Other intervention name(s): Conventional colonoscopy
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Intervention model description: Prospective, single-blinded, single center cohort study. All patients will undergo pan-intestinal capsule endoscopy followed by conventional colonoscopy with deep sedation in the same day, with no need for further bowel preparation.
Masking: Double (Care Provider, Investigator)
Primary purpose: Diagnostic
Keywords: iron deficiency anemia; gastrointestinal bleeding; pan-intestinal capsule endoscopy
The Optimal Effect Site Concentration of Propofol for Conscious Sedation in Elderly Male Patients Undergoing Urologic Surgery Under Spinal Anesthesia With or Without Intrathecal Fentanyl
Condition: Conscious Sedation Under Spinal Anesthesia
Study type: Interventional

Summary: 
      Since intrathecal fentanyl is known to sedation effect, intrathecal fentanyl will result in
      lowering propofol requirement for conscious sedation under spinal anesthesia.
    


Intervention name(s): propofol
Intervention type(s): Drug
Intervention description(s): 1.1 mcg/ml for initial effect site concentration during spinal anesthesia (The effect site concentration will be changed at each subject by Dixon's up-and-down method.)
Other intervention name(s): Pofol®
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Study on the Quality of Life Among Adolescents With Attention Deficit/Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      Attention Deficit Hyperactivity Disorder (ADHD) with a overall prevalence of 5.3% is one of
      the most common neurobehavioral disorders in children. In the foreign literature, many
      studies bring to light in children and adolescents the negative impact of ADHD on overall
      quality of life. Some of these studies were able to identify the fact that the higher the age
      of ADHD children or adolescents, the lower the quality of life. Currently, to our knowledge,
      only a few European studies have demonstrated the negative impact of ADHD on the quality of
      life of children and adolescents. In addition, these studies used only questionnaires
      intended for parents and not for children or adolescents.

      During a regular follow-up consultation with their referent child psychiatrist, adolescents
      accompanied by at least one of their parents will be informed of the modalities of our study.
      A newsletter will be delivered to parents and one to the adolescent. If neither the
      adolescent nor the parents is opposed to participate, the child psychiatrist will register
      the patient on the list of study participants. He will also fill out a medico-social
      information sheet about the adolescent as to summarize the data in the medical record. At the
      end of this consultation, in the waiting room, adolescents will answer questionnaires
      KIDSCREEN-27 and MSPSS; their parents will complete the CBCL questionnaire. These
      questionnaires will be handed to the secretary who will put them back in the patient's
      record. The KIDSCREEN-27, MSPSS and CBCL questionnaires as well as the medico-social
      information sheet will be source documents. The principal investigator or one of the
      associates investigators will complete the case report form from these source documents. For
      this purpose the data will be entered anonymously into a data entry software on a computer
      server secured by the Centre Psychothérapique de Nancy (CPN). Then, anonymous data from the
      software will be forwarded to Dr. Epstein of the Clinical Investigation Center for
      statistical analysis. The study will begin when the favourable opinion of the Ethical
      Research Comittees will be obtained and the study will last one year.
    

Detailed description: 
      Cross-sectional, descriptive epidemiological study based on single-centre trials
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adolescents (12 to 18 years old) with diagnosis of ADHD followed during regional child
        psychiatric consultation at Child department of Nancy University Hospital