bioihbjkbjnl/mcl2 huggingface dataset:
A Phase II Study of Hepalatide in Subjects With Chronic Hepatitis B
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase II Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-effect
      Relationship Study of Hepalatide for Injection Combined with Pegylated Interferon in Subjects
      with Chronic Hepatitis B
    

Detailed description: 
      The study is a 4-arm parallel design, randomized, double-blind, placebo-controlled,
      multicenter, dose-effect relationship, phase II clinical trial. The study is designed to
      assess efficacy and safety of 3 Doses of hepalatide in Combination with Pegylated Interferon
      Compared to Pegylated Interferon Alone in patients with Chronic Hepatitis B .Subjects will be
      randomly assigned to the 2.1mg, 4.2mg, and 6.3mg dose groups , 32 subjects in each group .
      The subjects in each dose group will be randomly and double-blindly administered the
      corresponding dose of trial drug or placebo in a ratio of 3:1. The subjects in each dose
      group who received placebo treatment combine as the placebo group. All subjects will receive
      Pegylated Interferon treatment for 28 weeks as the basic treatment,trial drug or placebo
      treatment for 24 weeks continuously , followed by a safety follow-up for 4 weeks.
    

Intervention name(s): Hepalatide 2.1mg; Hepalatide 4.2mg; Hepalatide 6.3mg; placebo 2.1mg; placebo 4.2mg; placebo 6.3mg; Pegylated Interferon
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 2.1 mg/day subcutaneously (s.c.) for 24 week; 4.2mg/day subcutaneously (s.c.) for 24 week; 6.3mg/day subcutaneously (s.c.) for 24 week; 2.1 mg/day subcutaneously (s.c.) for 24 week; 4.2 mg/day subcutaneously (s.c.) for 24 week; 6.3 mg/day subcutaneously (s.c.) for 24 week; 180 ug/week subcutaneously (s.c.) for 28 week
Other intervention name(s): L47; L47; L47; Pegasys
Intervention MeSH terms: Interferons
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Randomised Controlled Trial of Efficacy of Resistant Maltodextrins on Reducing Colonic Transit Time
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      The purpose of this study is to assess the efficacy of resistant maltodextrins, compared to
      placebo, in reducing the colonic transit time in healthy subjects.
    

Detailed description: 
      In the last fifty years we have drastically changed our eating habits, in particular our
      fibre intake. Our hunter-gatherer ancestors ate more than 100 species of fruit and
      vegetables, which contributed between 20 and 30 g of dietary fibre per day. Currently, a
      typical citizen of our country reaches 10% of that amount.

      Therefore, fibre deficiency alters digestion and metabolism, increasing nutrient absorption
      (obesity, increased insulin resistance, hyperlipidaemias), produces altered colonic
      metabolism (inflammatory bowel disease), and slows faecal transit (increasing the lumen
      pressure with diverticulosis, appendicitis, haemorrhoids and colon cancer. In addition, the
      prebiotic effect is important.

      Several studies have demonstrated the effectiveness of digestion-resistant maltodextrin in
      the treatment of chronic idiopathic constipation. Investigators carried out a single blind
      study among young people with constipation who were administered 9.2 grams of resistant
      maltodextrins per day or placebo, and found significant changes in defecation frequency and
      in faecal volume.

      Kimura et al. carried out a clinical trial in women with constipation and a defecation
      frequency of less than 3 times per week and administered 5 grams of resistant maltodextrins
      per day, demonstrating its effectiveness in significantly increasing the number of
      defecations per week, the number of days per week without defecation and the faecal volume.
      Additionally, an improvement was found aspects such as colour, stool odour and psychological
      feeling after defecation.

      Finally, an interesting feature of Resistant maltodextrins is that it normalises the colonic
      transit time without causing diarrhoea, whilst increasing the stool volume, moisture and
      frequency of defecation.

      The purpose of this study is to assess the efficacy of resistant maltodextrins, compared to
      placebo, in reducing the colonic transit time in healthy subjects.

      For That, 60 subjects will be stratified by gender (30 women: 15 with resistant maltodextrins
      and 15 placebo and 30 men: 15 with resistant maltodextrins and 15 placebo).
    

Intervention name(s): Resistant maltodextrins; placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 15 grams of Resistant maltodextrins per day dissolved in water during 21 days; 15gr placebo
Other intervention name(s): Fibersol®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Colonic transit; Dietary Fiber; Radiopaque marker
Vasculopathy, Inflammation and Systemic Sclerosis
Condition: Systemic Sclerosis
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis; Inflammation
Study type: Interventional

Summary: 
      It is a study of basic research with mechanistically objectives and including clinical
      biological samples.
    

Detailed description: 
      Systemic sclerosis (SSc) is a rare and severe disease characterised by a fibrotic process and
      an incompletely elucidate physiopathology. Several shared featured have been identified
      between SSc and another autoimmune disease, the systemic lupus erythematous (SLE) as an
      interferon-alpha signature, the role of platelets and the polymorphism of OX40 ligand
      (OX40L). In SLE, OX40L has been shown highly linked to the active form of the disease, was
      increased by the CD40L of platelets and induced the CD8 cytotoxicity while inhibiting the
      suppressive functions of regulator T lymphocytes. The third main factor of the SSc
      physiopathology apart from autoimmunity and fibrosis is the vasculopathy with an important
      role of endothelial cells (EC). They turned out to be half-professional antigen presenting
      cells and can modulate the adaptive immunity.
    

Intervention name(s): Blood samples; Biopsy
Intervention type(s): Biological; Biological
Intervention description(s): biological features of the standard follow-up
2 more blood tube for the biological collection (serum and PBMC); Skin biopsies
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: T lymphocyte; OX40/OX40L
Assessment of Stability of Mail-in Capillary Hemoglobin A1c Test Kit
Condition: Diabetes
Study type: Observational

Summary: 
      The purpose of this study is to determine the stability of capillary HBA1c blood samples
      collected by the participant with this kit and mailed to the laboratory at Children's Mercy
      Hospital.
    

Detailed description: 
      Participants are given home lab kit for obtaining HbA1c by capillary blood and shipping it to
      Children's Mercy Hospital and Clinics. They will mail in sample before their next visit and
      this result will be compared to the HbA1c performed during this visit.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male and females, age 1-17, receiving care in the Endocrine clinic at Children's Mercy
        Hospital who require HbA1c for standard of care.
      
Biospecimen description: 
      Capillary blood
    
Keywords: Diabetes
A Pharmacokinetic Study of JK1211(Itraconazole [Itrizole]) Oral Solution in Participants With Deep Mycosis and Those With Febrile Neutropenia Suspected of Fungal Infection
Condition: Mycoses; Candidiasis; Aspergillosis; Cryptococcosis; Blastomycosis; Histoplasmosis; Neutropenia
MeSH terms: Mycoses; Candidiasis; Aspergillosis; Histoplasmosis; Cryptococcosis; Blastomycosis; Neutropenia; Febrile Neutropenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the pharmacokinetics (how the drug is absorbed in the
      body, distributed within the body, and how it is removed from the body over time) of
      itraconazole (ITCZ) oral solution in participants with Systemic Fungal Infection (SFI) and
      those with febrile (with fever) neutropenia (FN, decrease in white blood cells) suspected of
      fungal infection.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), multicenter
      (conducted in more than 1 center) and uncontrolled (no competitive drugs involved) study.
      Participants with SFI will receive treatment with ITCZ oral solution or switch treatment from
      intravenous (into a vein) infusion of itraconazole (ITCZ-intravenous) to ITCZ oral solution
      as per Investigator's discretion. All the participants with FN suspected of fungal infection
      will receive the switch treatment from ITCZ- intravenous to ITCZ oral solution. The study
      will include 3 periods: Pre-observation period (7 days), Treatment period (85 days for ITCZ
      oral solution monotherapy and 99 days for switch treatment) and Follow-up observation period
      (30 days). The participants who receive ITCZ oral solution monotherapy will receive ITCZ oral
      solution without ITCZ-intravenous in the dose range of 20 milliliter (ml) per day to 40 ml
      per day for 12 weeks (85 days) and those on the switch treatment will receive 400 milligram
      (mg) per day ITCZ-intravenous twice for first 2 days followed by 200 mg per day
      ITCZ-intravenous up to 14 days and then they will be administered treatment as per ITCZ oral
      solution monotherapy. Efficacy will primarily be evaluated by assessing the pharmacokinetics.
      Participants' safety will be monitored throughout the study.
    

Intervention name(s): ITCZ Oral Solution; ITCZ-IV
Intervention type(s): Drug; Drug
Intervention description(s): ITCZ syrup product containing ITCZ 10 mg per ml in dose range of 20 ml to 40 ml daily for 7 days up to 12 weeks; 200 mg IV twice daily for 2 days and once daily for the next 1 to 12 days
Other intervention name(s): Itrizole Oral Solution 1%, JK1211
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mycoses; Candidiasis; Aspergillosis; Cryptococcosis; Blastomycosis; Histoplasmosis; Neutropenia; Itraconazole; JK1211
A Multi-omics Disease Signature Trial in Adult Patients With Moderate to Severe AD
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical trial will investigate the effectiveness and safety of a new active ingredient
      (LEO 138559) in the treatment of moderate to severe atopic dermatitis (AD). It is given by
      subcutaneous injection. Some people in the trial will instead receive Dupixent® which is an
      approved treatment for moderate to severe AD. Dupixent® is also given by subcutaneous
      injection.

      The main aim of this clinical trial is to investigate which changes in biomarkers in the skin
      are caused by LEO 138559 and Dupixent®.

      The trial includes a screening phase of up to 4 weeks, followed by a treatment period of 16
      weeks, and a safety follow-up period of 16 weeks.
    


Intervention name(s): LEO 138559; Dupixent®
Intervention type(s): Drug; Drug
Intervention description(s): LEO 138559 is an antibody given by subcutaneous injection.; Dupixent® is an antibody given by subcutaneous injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Drug-drug-interaction Study of Ramipril, Amlodipine and Atorvastatin
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to determine the potential pharmacokinetic interaction of ramipril (and ramiprilat),
      atorvastatin as atorvastatin calcium trihydrate and amlodipine as amlodipine besilate at
      steady state after a multiple oral administration and to monitor the safety of the
      co-administration of these drugs. This study aims to determine if the steady state study
      pharmacokinetic parameters of any of the given drugs and the tolerability is altered when
      administered concomitantly.
    

Detailed description: 
      This study was an open-label, comparative, multiple-dose, fixed sequence steady state trial
      to compare the pharmacokinetic of ramipril, atorvastatin as atorvastatin calcium trihydrate,
      amlodipine as amlodipine besilate given as a multiple dose under fasting conditions in the
      absence and presence of each other.

      Bioanalysis of ramipril, ramiprilat, atorvastatin and amlodipine is performed by LC/MS/MS
      method.
    

Intervention name(s): Ramipril, Amlodipine and Atorvastatin
Intervention type(s): Drug
Intervention description(s): compare the pharmacokinetic of ramipril (and ramiprilat), atorvastatin as atorvastatin calcium trihydrate, amlodipine as amlodipine besilate from reference products given as a multiple dose
Intervention MeSH terms: Amlodipine; Ramipril; Amlodipine, atorvastatin drug combination; Atorvastatin
Intervention model: Single Group Assignment
Intervention model description: Subjects are to be admitted the night before dose no. 1 administration, confining at clinical site until the 24 hours post dose no. 5 administration. 4-days off interval between last dose of treatment A and first dose of treatment B allowed. Subjects to be admitted the night before dose no. 6 administration, confining at clinical site until the 24 hours post dose no. 10 administration. 4-days off interval between last dose of treatment B and first dose of treatment C allowed. Subjects to be admitted the night before dose no. 11 administration, confining at clinical site until the 24 hours post dose no. 26 administration.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ramiprilat; ramipril; amlodipine; atorvastatin; drug interaction; multiple-dose; pharmacokinetic
A Phase I Study of TS-172 in Healthy Adult Subjects (Single and Multiple Doses)
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, Single-Center, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the
      Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending and Multiple Dose of
      TS-172 in Healthy Adult Subjects
    


Intervention name(s): TS-172; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single doses of TS-172 10 mg, 30 mg, 90 mg, 270 mg before breakfast in each period (only 30 mg administered before breakfast and fasting)
Multiple dose of TS-172 90 mg before breakfast and dinner; Single doses of TS-172 placebo before breakfast in each period (only placebo administered before breakfast and fasting in step 2)
Multiple dose of TS-172 placebo before breakfast and dinner
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Evaluation of Safety and Immunogenicity of Co-administering HPV Vaccine With Other Vaccines in Healthy Female Subjects
Condition: Infections, Papillomavirus
Study type: Interventional
Phase: Phase 3

Summary: 
      Infection with human papillomavirus (HPV) has been clearly established as the central cause
      of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and
      thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical
      cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescents
      platform. Therefore, this Phase 3b study is designed to evaluate the safety and
      immunogenicity of co-administering Boostrix and/or Menactra with GSK Biologicals' HPV vaccine
      (580299) as compared to the administration of any of the vaccines alone.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    


Intervention name(s): Different formulations of GSK Biologicals' HPV vaccine (580299); Menactra TM; Boostrix TM
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Three doses of vaccine administered intramuscularly, with the second and third dose given one month and six months after the first dose respectively; One dose of vaccine administered intramuscularly; One dose of vaccine administered intramuscularly
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HPV; HPV, diptheria, pertussis, tetanus, meningitis
The Efficacy of Dynamic Hand Splint Treatment in Spastic Hemiparetic Patients
Condition: Stroke; Brain Injuries
MeSH terms: Brain Injuries
Study type: Interventional

Summary: 
      The purpose of this randomized controlled trial was designed to study the efficacy of dynamic
      hand splinting on spastic hemiparetic patients due to stroke or traumatic brain injury.
    

Detailed description: 
      Subjects were recruited from both inpatients and outpatients who received rehabilitation
      programs in the Department of Physical Medicine and Rehabilitation at a regional teaching
      hospital in Taiwan. The participants were randomly divided into two groups: the splint group
      and the control group. The subjects in the splint group received 1-hour task-oriented
      training with wearing a customized dynamic hand splint, totally 15 times in a duration of one
      month plus conventional rehabilitation programs. The subjects in the control group received
      the same treatments but without splint used. Evaluations including Modified Ashworth Scale
      (MAS), active range of motion (AROM), grip strength, Fugl-Meyer Assessment (FMA), Motor
      Activity Log 30(MAL), and F/M ratio were performed at baseline, post-training, and 2 months
      later after the intervention finished, and the evaluators were blinded to the grouping of the
      subjects.
    

Intervention name(s): Task-oriented training with a dynamic hand splint; Task-oriented training without a dynamic hand splint
Intervention type(s): Behavioral; Behavioral
Intervention description(s): In addition to conventional rehabilitation programs (therapy-as-usual), the subject in the splint group received 1-hour task-oriented training with wearing a customized dynamic hand splint, totally 15 times in a duration of one month. The content of task-oriented training contained picking cubes from side to side with three-jaw grasp, lifting the cone to the shoulder height with the cylindrical grip and an extended elbow, picking up pegs and inserting it into the hole with palmar pinch, and grasping a soap to simulate wiping the body. Among the four tasks, two were chosen to train the subjects according to the abilities of subjects.; In addition to conventional rehabilitation programs (therapy-as-usual), the subject in the no-splint group received 1-hour task-oriented training, totally 15 times in a duration of one month. The content of task-oriented training contained picking cubes from side to side with three-jaw grasp, lifting the cone to the shoulder height with the cylindrical grip and an extended elbow, picking up pegs and inserting it into the hole with palmar pinch, and grasping a soap to simulate wiping the body. Among the four tasks, two were chosen to train the subjects according to the abilities of subjects.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: spasticity; dynamic hand splint; stroke; traumatic brain injury
Effect of Bran Fiber Type on Subjective and Objective Measures of Appetite
Condition: Food
Study type: Interventional

Summary: 
      The objective of this study is to determine the satiety value of different bran fibers on
      appetite & subsequent food intake with acute consumption. Satiety will be measured
      subjectively by visual analogue scales (VAS).
    

Detailed description: 
      Visual analogue scales will be used to measure satiety at 15, 30 45, 60, 120, 180, and 240
      minutes
    

Intervention name(s): Dietary fiber
Intervention type(s): Dietary Supplement
Intervention description(s): Wheat, barley, oat and bran fibers added to a breakfast product
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: The focus of this study is to determine satiety
Bioequivalence Study of Fixed Dose Combination of 2.5 mg Saxagliptin/850 mg Metformin Tablet Relative to 2.5 mg Onglyza and 850 mg Glucophage Tablets Co-Administered
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate bioequivalence of a 2.5 mg saxagliptin/850 mg metformin fixed dose combination
      (FDC) tablet relative to the 2.5 mg saxagliptin tablet and 850 mg metformin (Glucophage
      Marketed by Merck-Serono) tablet co-administered to healthy subjects in the fasted and fed
      condition.
    


Intervention name(s): saxagliptin; metformin; saxagliptin + metformin (FDC tablet)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets, Oral, 2.5 mg, once daily, single dose; Tablets, Oral, 850 mg, once daily, single dose; Tablet, oral, (saxagliptin 2.5 mg) (metformin 850 mg), once daily, single dose
Other intervention name(s): Onglyza; Glucophage
Intervention MeSH terms: Metformin; Saxagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Trial to Determine the Safety and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live, Cold-Adapted (CAIV-T) in Healthy Children
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      - The purpose of this study is to determine the efficacy of CAIV-T in a diverse Asian
      population aged from 6 months to less than 36 months, in tropical and temperate climates,
      against culture-confirmed influenza illness. In addition, the trial provides the opportunity
      to investigate the efficacy of CAIV-T over multiple influenza seasons, and to investigate the
      effect of CAIV-T on acute otitis media.
    


Intervention name(s): CAIV-T, Liquid
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Prevention