bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate Safety, Tolerability, PK and PD of HLX01 in Patients With CD20-positive B-cell Lymphomas
Condition: B-cell Lymphomas
MeSH terms: Lymphoma; Lymphoma, B-Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of HLX01 (a potential
      rituximab biosimilar) in patients with CD20-positive B-cell lymphomas.
    

Detailed description: 
      This was a phase Ia, multicenter, open-label, dose-escalation clinical study to evaluate the
      safety, tolerability, pharmacokinetics and pharmacodynamics characteristics of HLX01
      injection in patients with CD20-positive B-cell lymphomas.
    

Intervention name(s): HLX01
Intervention type(s): Drug
Intervention description(s): a potential rituximab biosimilar
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Single Ascending Dose Trial to Evaluate the Safety, Tolerability, PK, and PD of MT1002 for Injection
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, dose-escalation study to evaluate the safety, tolerability,
      pharmacokinetics, and pharmacodynamics of a single dose of MT1002 for injection following
      intravenous bolus/infusion ascending dose administration.
    

Detailed description: 
      An initial, single dose escalation study of MT1002 for injection for injection in heathy
      subjects will be performed to evaluate safety, pharmacokinetics, and pharmacodynamics after
      intravenous bolus and infusion administration.

      A total of 36 subjects (6 subjects per cohort) in 6 dose levels . At each dose level, a
      single sentinel subject will be dosed first. Sentinel subjects will receive a phone call at
      48 hours ±4 hours to inquire about their status. If no dose-limiting toxicity is observed for
      48 hours post-dose, the remaining 5 subjects in that dose level will be treated.
    

Intervention name(s): MT1002 for injection
Intervention type(s): Drug
Intervention description(s): Study drug will be administered by an intravenous bolus dose followed by an infusion of 4 hours.
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Internet for Anesthesia Information : a Patient Questionaire
Condition: Anaesthesia
Study type: Observational [Patient Registry]

Summary: 
      Patients need information for perioperative period and internet may be an interesting
      alternative.This study analysed by questionaire what does patient look on internet:
      information of perioperative period and specifically for anesthesia. Questionaire (8
      questions) are distributed to the patient before surgery and after they were prepared by
      surgeon. Population : adult (> 18 y), no emergency procedure.The mean question is the use of
      internet for anesthesia information.
    

Detailed description: 
      This is a prospective study with 23 centers ( France, Suisse, Belgium, Canada) including
      before surgery: adult (> 18y), no emergency procedure. Questionaires (8 questions) are
      distributed to the patient before surgery and after they were prepared by surgeon. After
      collecting all questionaires, questionaires are analysed by an independant center. The mean
      question is the use of internet for anesthesia information. More than 8000 patients have to
      be enrolled during the study period over 23 centers.
    

Intervention name(s): questionaire
Intervention type(s): Other
Intervention description(s): questionaire before surgery
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult (> 18 yrs), schedulled for surgery under local, regional or general surgery
      
Keywords: internet; anesthesia; information; surgery; question
The Cytogenetic Constitution of Embryos Resulting From Immature Oocytes (M1)
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      To examine the chromosomal number content in the blastomeres of embryos achieved from
      fertilization of immature oocytes at MI stage recruited following COH for IVF.

      comparison of the genetic number content of embryos and their quality in terms of cleavage
      rate and morphological score reached after fertilization of immature oocytes at MI stage
      whether arrested at the MI stage or extruded the polar body, after in vitro maturation for a
      variable length of time.
    

Detailed description: 
      Patients undergoing routine IVF, following informed consent, donated some of their unusable,
      immature- MI stage oocytes for our research. Following in vitro maturation for up to 2, 4, 8
      and 24 hours after harvest, all immature oocytes in these 4 study groups underwent
      intracytoplasmic donor sperm injection (ICSI), whether they extruded their polar body (MI-PB
      or rescued MI) or not (arrested MI). Oocyte fertilization rate after 24 hours and embryonic
      development in terms of cleavage rate and morphology were assessed, for another 48 hours.
      Then the whole embryo was prepared for molecular cytogenetic evaluation using FISH
      (Fluorescence in situ hybridization) analysis of chromosomes x, y and 18.
    

Time perspective: Prospective
Keywords: MI oocytes, FISH,chromosomal aberrations
Safety and Efficacy Study of Omalizumab to Treat Allergic Asthma
Condition: Allergic Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The primary purpose is to evaluate the safety and efficacy of recombinant humanized anti-IgE
      monoclonal antibody injection in patients with allergic asthma.
    

Detailed description: 
      Omalizumab will be given as add-on treatment to budesonide inhaled powder in patients with
      moderate or severe allergic asthma(IgE>=60IU/ml), who demonstrate inadequate asthma symptom
      control. Response to Omalizumab will be assessed by the overall improvement in control of
      asthma.

      Omalizumab is a recombinant humanized monoclonal antibody that selectively binds to human
      immunoglobulin E(IgE). The antibody has a molecular weight of approximately 150 kilodaltons
      and produced by Chinese Hamster Ovary cell.

      Omalizumab inhibits the binding of IgE to the high-affinity IgE receptor on the surface of
      mast cells and basophils. Reduction in surface-bound IgE on cells limits the degree of
      release of mediators of the allergic response.
    

Intervention name(s): Omalizumab; placebo
Intervention type(s): Drug; Drug
Intervention description(s): The recommended dose is 0.016mg/kg/IgE(IU/ml) every 4 weeks. It is administered by subcutaneous injection.If the total dose per 4 weeks is 150~300mg, the dosing interval will be every 4 weeks; if the total dose per 4 weeks is 450mg~750mg，then dosing interval is every 2 weeks.
Other intervention name(s): other name: Aomaishu; Recombinant Humanized Anti-IgE Monoclonal Antibody
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Omalizumab; IgE; Asthma
The Effect of Dupilumab on Lung Inflammation and Related Changes in Airway Volumes Detectable by Functional Respiratory Imaging in Patients With Moderate-severe Asthma
Condition: Asthma
MeSH terms: Asthma; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      • To assess the effect of dupilumab on lung inflammation and related changes in airway
      volumes detectable by functional respiratory imaging

      Secondary Objective:

        -  To evaluate the effect of dupilumab at Week 24 on bronchodynamics, hyperinflation,
           airway resistance, airway wall thickness, ventilation defects and mucus plugging derived
           from high-resolution computed tomography (HRCT) scans, patient-reported outcomes, FeNO
           and spirometry.

        -  To evaluate safety of dupilumab
    

Detailed description: 
      The study duration for each participant will be a total of minimum 29 weeks and up to 41
      weeks. This includes 4 weeks +/-1 week screening period, 24 weeks of treatment period and a
      follow-up period up to 12 weeks or until the patients switch to commercialized dupilumab (or
      other biologic products), whatever comes first.
    

Intervention name(s): Dupilumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): solution for injection subcutaneous; Solution for injection subcutaneous
Other intervention name(s): SAR231893 Dupixent
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Clinical Test for Blood Pressure Meter of CH-101
Condition: Blood Pressure
Study type: Observational

Summary: 
      Blood pressure meter model CH-101 was to be assessed against the standard mercury
      sphygmomanometer according to the protocol of the ANSI/AAMI SP-10.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Community sample
      
Keywords: blood pressure
Controlled Study Comparing REPaiR® and MIST Therapies for Treatment of Periodontitis
Condition: Periodontal Diseases
MeSH terms: Periodontitis; Periodontal Diseases
Study type: Interventional

Summary: 
      A comparison of laser (REPaiR) compared with minimally invasive surgical therapy for moderate
      to severe periodontal disease.
    

Detailed description: 
      The Trial is a multi-center, randomized, blinded, parallel arm trial of REPaiR therapy
      (experimental treatment) versus MIST (control therapy) in a maximum of 2 qualifying
      periodontal study teeth will be treated in each subject. Qualifying teeth will have PPD ≥ 6mm
      and intrabony vertical ≥ 3 mm, with base of defect ≥ 3 mm coronal to the tooth apex, and
      defect angle ≥ 25°.

      For Subjects already in maintenance therapy and having completed scaling and root planing
      within the previous 6-months, up to 3 Study Teeth will be selected and SRP conducted on just
      these teeth, and subjects will be randomized to either Test or Control Therapies (Visit 3).
      For patients already in maintenance therapy and NOT having completed SRP within the previous
      6-months, up to 3 qualifying teeth may be selected, and localized SRP in the study teeth
      quadrants (Visit 2) can be followed after 4-6 weeks by Visit 3 Therapy on up to 2 Study
      Teeth. Other subjects not in maintenance therapy and with up to 3 qualifying teeth will be
      selected at the Screening Visit; then 4-6 weeks following SRP, up to 2 Study Teeth will be
      selected, and subjects will be randomized to either Test or Control Therapies. Follow-up
      assessments will be conducted on all subjects by a blinded examiner over a 12-month period.
    

Intervention name(s): MIST (minimally invasive surgical therapy)
Intervention type(s): Device
Intervention description(s): REPaiR Periodontal Therapy
Other intervention name(s): REPaiR
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, blinded, parallel arm trial, non-inferiority comparison of REPaiR therapy (experimental treatment) versus MIST (control therapy)
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Bioequivalence Study of Doxycycline Monohydrate Tablets Under Fed Conditions
Condition: To Determine Bioequivalence Under Fed Conditions
MeSH terms: Malnutrition; Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the single-dose bioequivalence of Par and Oclassen
      doxycycline monohydrate 100 mg.
    

Detailed description: 
      To compare the single-dose bioequivalence of Par and Oclassen (Monodox(R)), 100 mg
      doxycycline under fed and fasting conditions.
    

Intervention name(s): doxycycline monohydrate; doxycycline monohydrate; doxycycline monohydrate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): tablet, 100 mg, single, oral dose; Capsule, 100 mg, single, oral dose; Capsule, 100 mg, single, oral dose
Other intervention name(s): Monodox(R); Monodox (R); Monodox(R)
Intervention MeSH terms: Doxycycline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: bioequivalence; doxycycline monohydrate; fed
Bioequivalence Study of Tramadol Hydrochloride /Paracetamol Tablets Versus Ultracet Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The sponsor, Pfizer has developed a formulation of tramadol hydrochloride/ paracetamol 37.5
      mg/ 325 mg (test drug) as a generic alternative to the reference listed product Ultracet®. In
      order to meet the requirements for registration as a generic drug, this study is being
      conducted to demonstrate the bioequivalence between the formulation of tramadol
      hydrochloride/ paracetamol 37.5 mg/ 325 mg provided by Pfizer and the reference drug tramadol
      hydrochloride/ paracetamol 37.5 mg/ 325 mg, available in the pharmaceutical market in Brazil
      (Ultracet®, Janssen Cilag Farmacêutica Ltda).
    


Intervention name(s): Ultracet Tablets; Tramadol hydrochloride 37.5 mg/Paracetamol 325 mg tablets - tablet (Pfizer)
Intervention type(s): Drug; Drug
Intervention description(s): Ultracet tablet (Janssen Cilag Farmacêutica Ltda) equivalent to Tramadol hydrochloride 37.5 mg/Paracetamol 325 mg; Tramadol hydrochloride 37.5 mg/Paracetamol 325 mg tablets (Pfizer)
Other intervention name(s): Reference drug; Test Drug
Intervention MeSH terms: Acetaminophen; Tramadol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Viral Inhibition in Children for Treatment of RSV
Condition: RESPIRATORY SYNCYTIAL VIRUS INFECTIONS
MeSH terms: Infections; Virus Diseases; Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      VICTOR is a randomized, double-blind, placebo-controlled, multicenter, 2-part study to
      evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antiviral effect
      of single and multiple dosing of AK0529 in infants hospitalized with RSV infection.
    

Detailed description: 
      Globally, Respiratory Syncytial Virus (RSV) is recognized as the leading cause of respiratory
      tract infections in infants and young children and a major cause of hospitalization due to
      severe respiratory infection. Despite four decades of effort, there are still no effective
      methods to control RSV infection. Treatment of RSV has been limited to supportive measures.
      There is an urgent need for safe and effective drugs to treat and prevent RSV disease.

      AK0529 is an investigational antiviral agent that targets the RSV fusion protein on the
      surface of the viral envelope and exerts antiviral activity against RSV by inhibiting viral
      entry into host cells and preventing fusion protein induced cell-cell fusion. AK0529 was
      generally well tolerated in healthy volunteers.

      This study is designed as a randomized, double-blind, placebo-controlled, multicenter, phase
      2 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and
      antiviral effect of single and multiple dosing of AK0529 in infants hospitalized with RSV
      infection. It will consist of two parts, Part 1 and Part 2. Each part will consist of three
      phases, a pre-treatment phase, a treatment phase and post-treatment follow-up phase.
    

Intervention name(s): AK0529; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): AK0529 is a novel compound being developed for the treatment of RSV infection. The enteric coated drug pellets with sugar core can be administered orally with apple sauce/purée or yoghurt, or by flushing with 10% dextrose water via a nasogastric or other feeding tube, or upon a glucose wafer.; The placebo was made with the same smell and appearance as AK0529 but without the active ingredients. The placebo supplements are composed primarily of microcrystaline cellulose pellet.
Intervention MeSH terms: Ziresovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: RSV; AK0529
Treatment of Chronic Bacterial Prostatitis
Condition: Chronic Bacterial Prostatitis
MeSH terms: Prostatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Background - bacterial prostatitis (BP) is a common condition accounting responsible for
      about 5-10% of all prostatitis cases; chronic bacterial prostatitis (CBP) classified as type
      II, are less common but is a condition that significantly hampers the quality of life, (QoL)
      because not only is it a physical condition but also a psychological distress. Commonly
      patients are treated with antibiotics alone, and in particular fluoroquinolones are suggested
      by the European Urology guidelines. This approach, although recommended, may not be enough.
      Thus, a multimodal approach to the prolonged antibiotic therapy may be helpful.

      Methods - 210 patients affected by chronic bacterial prostatitis were enrolled in the study.
      All patients were positive to Meares-Stamey test and symptoms duration was > 3 months. The
      purpose of the study was to evaluate the efficacy of a long lasting therapy with a
      fluoroquinolone in association with a nutraceutical supplement (prulifloxacin 600 mg for 21
      days and an association of Serenoa repens 320 mg, Lactobacillus Sporogens 200 mg, Arbutin 100
      mg for 30 days). Patients were randomized in two groups (A and B) receiving respectively
      antibiotic alone and an association of antibiotic plus supplement.
    


Intervention name(s): Third generation fluoroquinolone; Nutritional supplement + third generation fluoroquinolone
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Prulifloxacin 600 mg; Serenoa repens 320 mg, Lactobacillus Sporogens 200 mg, Arbutin 100 mg and prulifloxacin 600 mg
Intervention MeSH terms: Fluoroquinolones
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dexmedetomidine Versus Ketamine Versus Midazolam in Endoscopic Procedures
Condition: Sedation and Analgesia
Study type: Interventional

Summary: 
      This study aims to assess the safety and efficacy of dexmedetomidine versus ketamine versus
      midazolam combined with propofol in cancer patients undergoing gastrointestinal endoscopic
      procedures.
    

Detailed description: 
      Comparison between using intravenous (IV) propofol combined with either IV dexmedetomidine or
      IV ketamine or IV midazolam; to study the effect of their combination on level of sedation
      and hemodynamic stability on adult patients scheduled for gastrointestinal endoscopic
      procedures.
    

Intervention name(s): Dexmedetomidine; Ketamine; Midazolam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): intravenous dexmedetomidine 1 mic/kg; ketamine 1mg/kg; midazolam 0.05 mg/kg
Other intervention name(s): propofol- dexmedetomidine; propofol- ketamine; propofol- midazolam
Intervention MeSH terms: Midazolam; Dexmedetomidine; Ketamine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Clinical Trial of Trelagliptin Succinate Tablets in the Treatment of Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The trial used a randomized, double-blind, placebo-controlled, superior-effect design,
      multicenter clinical study.

      The trial was divided into a test group and a placebo group,the two groups were randomized in
      a 1:1 ratio and planned to enroll 240 patients with type 2 diabetes. After 2 weeks of
      screening, all subjects entered the treatment period,which was 24 weeks, and 1 week period of
      follow-up.
    

Detailed description: 
      The trial was divided into a test group and a placebo group: the test group was given
      trelagliptin succinate tablets, and the placebo group was given placebo. The test group and
      the placebo group were randomized in a 1:1 ratio and planned to enroll 240 patients with type
      2 diabetes. After 2 weeks of screening, all subjects entered the treatment period,which was
      24 weeks, and 1 week period of follow-up.

      All subjects were asked to continue their current diabetes diet and physical activity
      treatment plan throughout the study period.
    

Intervention name(s): Trelagliptin Succinate; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): the experimental group will use trelagliptin succinate 100 mg for 24weeks; the placebo Comparator groups use placebo oral tablet for 24weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: type 2 diabetes; monotherapy; trelagliptin succinate
Enlighten: An Adaptive Technology Weight Loss Intervention
Condition: Obesity; Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

Summary: 
      The Enlighten study is an 8-week trial investigating the response to use of a smartphone diet
      and activity application. Participants are enrolled as part of a worksite intervention, and
      will receive the LoseIt! weight loss smartphone application, which requires participants to
      self-monitor dietary intake and physical activity, a component shown to effectively produce
      weight loss. The application will be programmed to deliver dietary intake recommendations
      during the first three weeks of the intervention. At the 3 week time point, self-monitoring
      adherence via the smartphone application will be assessed and those who are not responding
      will receive 4 weekly telephone coaching sessions. Those individuals who respond at the end
      of 3 weeks will be encouraged to continue self-monitoring on the application. All
      participants will also receive regular text messages throughout the trial. The importance of
      the proposed research lies in the objective to reconfigure weight loss treatment so as to
      achieve the intended outcome more efficiently and in a manner that allows greater reach.
    


Intervention name(s): Technology Supported
Intervention type(s): Behavioral
Intervention description(s): All participants will complete 8 weeks of recording of dietary intake, weight, and physical activity on a smartphone application. Time-stamped data from the smartphone will upload automatically to the application server, where it will be visible to the lifestyle coach. The participant's real-time diet, activity and weight data relative to their goals will be visually depicted on the participant's smartphone. The coach will monitor participant adherence and send supportive text messages. Response to the application will be assessed 3 weeks after enrollment into the study; measured by number of food items recorded between weeks 1-3 of the intervention; an indicator of use and adherence. Based on adherence, some participants may receive 4 telephone coaching sessions between weeks 5 and 8. Telephone coaching sessions will include feedback on self-monitoring and goal attainment, problem solving, and motivational interviewing.
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment