bioihbjkbjnl/mcl2 huggingface dataset:
Study of Two Doses of ABX464 in Participants With Moderate to Severe Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase IIa study aims at investigating the safety and tolerability of 2 dose-levels of
      ABX464 administered daily in combination with methotrexate (MTX) in patients with moderate to
      severe active Rheumatoid Arthritis (RA) who had an inadequate response to MTX or/and to one
      or more anti- tumor necrosis factor alpha (TNFα) therapies.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, multicenter study. The study will
      consist of 3 phases: a screening phase, a treatment phase, and a follow-up phase.

      Approximately 60 participants with active Rheumatoid Arthritis will be randomly assigned to
      receive placebo, 50mg ABX464 or 100mg ABX464 during the treatment phase.

      The maximum period of active treatment will be 12 weeks. The maximum duration of study
      participation will be 17 weeks.

      Participant safety will be monitored throughout the study. In addition, several experimental
      and clinical endpoints will be assessed to obtain information on preliminary efficacy.
    

Intervention name(s): ABX464 50mg; Matching Placebo; ABX464 100mg; Methotrexate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): ABX464 is a new anti-inflammatory drug; placebo matching with ABX464; ABX464 is a new anti-inflammatory drug; MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Other intervention name(s): obefazimod 50mg; Placebo; obefazimod 100mg; MTX
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
PROGNOSTIC ROLE OF SERUM ALBUMIN LEVEL IN RADIOLOGICAL PROGRESSION OF GONARTHROSIS: IS IT A BIOMARKER IN ITSELF? A BIOMARKER ASSOCIATED WITH SYSTEMIC INFLAMMATION?
Condition: Gonarthrosis; Serum Albumin Low
MeSH terms: Osteoarthritis, Knee; Osteoarthritis; Inflammation
Study type: Observational

Summary: 
      The aim of our study is to evaluate the prognostic roles of serum albumin level and systemic
      inflammation-related indices, including and not including serum albumin level, in the
      radiological progression of gonarthrosis. In this retrospective study, between 10.01.2017 and
      10.01.2022, the data of the patients between the ages of 50-80, who applied to Ufuk
      University Physical Medicine and Rehabilitation clinic with the complaint of knee pain and
      met the clinical criteria of the American Rheumatology Association for gonarthrosis (knee
      osteoarthritis) (knee pain on many days of the previous month, crepitation with active joint
      movement, morning stiffness lasting ≤ 30 minutes, age ≥38 years, bone enlargement of the knee
      on examination),and whose knee radiography and blood tests were evaluated at admission were
      scanned.
    


Intervention name(s): serum albumin level
Intervention type(s): Other
Intervention description(s): serum albumin level in gonarthrosis
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        - In this retrospective study, between 10.01.2017 and 10.01.2022, the data of the patients
        between the ages of 50-80, who applied to Ufuk University Physical Medicine and
        Rehabilitation clinic with the complaint of knee pain and met the clinical criteria of the
        American Rheumatology Association for gonarthrosis and whose knee radiography and blood
        tests were evaluated at admission were scanned. In order to compare the parameters to be
        included in the study, the data and blood tests of patients between the ages of 50-80 who
        applied to Ufuk University Physical Medicine and Rehabilitation clinic between 10.01.2017
        and 10.01.2022 for reasons other than knee pain were scanned.
Netrin-1 and Placenta Accreta
Condition: Placenta Accreta
MeSH terms: Placenta Accreta
Study type: Interventional

Summary: 
      Netrin-1 is a secreted protein, which was first identified as a neuronal guidance factor. It
      is expressed in a multitude of tissues as pancreas, lung, breast, and placenta. Netrin-1 is a
      multifunctional protein, involved in cell polarity, adhesion, angiogenesis, apoptosis,
      migration, morphogenesis, and differentiation of various cell types. Most of netrin-1
      activity occur through signaling pathways induced by its two main receptors, DCC (deleted in
      colorectal cancer) and UNC5H (uncoordinated-5 homolog). Its receptors have been linked to the
      processes of apoptosis and angiogenesis. In absence of netrin-1, DCC and UNC5H receptors lead
      to apoptosis. In contrary, in presence of netrin-1, receptors transduce molecular cascades
      leading to proliferation, differentiation and migration of the cells. Netrin-1 has been
      involved in the pathogenesis of multiple diseases, as diabetes, cardiovascular diseases, and
      cancer. Serum Netrin-1 levels were high in preeclamptic patients.
    


Intervention name(s): Pregnant women at 28-32 weeks; at delivery
Intervention type(s): Other; Other
Intervention description(s): Pregnant women at gestational age 28-32 weeks; women delivered at term
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Cohort Study of Chronic Heart Failure
Condition: Analyze Etiology, Comorbidities, Clinical Characteristics
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      The purpose is to understand the clinical characteristics of chronic heart failure as soon as
      possible, analyze the etiology, comorbidities, clinical characteristics, and treatment of
      heart failure patients, observe the gap between real-world clinical practice and guideline
      recommendations, and provide reference for the improvement of heart failure prevention and
      treatment in China.
    

Detailed description: 
      Inclusion criteria:

        1. Accompanied by difficulty breathing, fatigue, or decreased activity tolerance;

        2. Signs of fluid retention (pulmonary congestion and peripheral edema);

        3. Echocardiography shows abnormalities in cardiac structure and/or function;

        4. Elevated levels of natriuretic peptide: B-type natriuretic peptide (BNP)>35 ng/L and/or
           N-terminal B-type proBNP (NT proBNP)>125 ng/L.

        5. HF hospitalization recorded within the previous 12 months

      Exclusion criteria:

        1. Concomitant severe liver function, renal failure, or other severe system dysfunction

        2. Poor compliance, inability to obtain information, or voluntary refusal to participate in
           this study.
    

Intervention name(s): No Intervention
Intervention type(s): Other
Intervention description(s): no intervention
Observational model: Cohort
Time perspective: Retrospective
Intestinal Flora Sequencing for Nasopharyngeal Carcinoma
Condition: Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Study type: Observational

Summary: 
      This study investigated the correlation between the changes in the intestinal flora and NPC
      by an examination of the intestinal flora and multiple clinical indicators of the blood of 8
      carefully screened patients of familial NPC, 24 patients of sporadic NPC and 27 healthy
      controls and a comparison of the differences in their intestinal flora structures and
      biological functions. By analyzing the function of the intestinal floras of NPC patients, we
      aimed to provide a better biological marker for patients with familial and sporadic NPC and
      constructed a disease prediction model for high-risk populations.
    

Detailed description: 
      Nasopharyngeal carcinoma (NPC) is a malignant nasopharyngeal disease with a complicated
      etiology that occurs mostly in southern China. Intestinal flora imbalance is believed to be
      associated with a variety of organ malignancies. Currently, the relationship between
      intestinal flora and NPC is not clear, although many studies have shown that intestinal flora
      can be used as a biomarker for many cancers and to predict cancer.

      To compare the differences in intestinal flora compositions and biological functions among
      patients with familial NPC (NPC_F), patients with sporadic NPC (NPC_S) and healthy controls
      (NOR), we compared the intestinal flora DNA sequencing and hematological testing results
      between every two groups using bioinformatic methods.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        We recruited 481 NPC patients and staged their tumor status with the AJCC 7th edition
        staging criteria，at the same time, 87 healthy volunteers were recruited.
      
Biospecimen description: 
      The faeces and the sera of the recruited participants
    
Keywords: Biomarker; nasopharyngeal carcinoma; familial; sporadic; intestinal flora
A Biopharmaceutics Study to Assess the Pharmacokinetics of Single Oral and IV Doses of Olorofim
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, single-centre, randomised, open-label, crossover study in 24 healthy
      subjects. Twelve subjects will each receive olorofim as a single IV infusion, single oral
      dose (fasted) and single oral dose (fed) and 12 subjects will each receive olorofim orally as
      intact tablets and via NG tube
    


Intervention name(s): Olorofim
Intervention type(s): Drug
Intervention description(s): 150 mg
Other intervention name(s): F901318
Intervention MeSH terms: Olorofim
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 3 Treatment Periods for Cohorts A and B 2 Treatment Periods for Cohort C
Masking: None (Open Label)
Primary purpose: Other
A Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer
Condition: Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
MeSH terms: Adenocarcinoma; Esophageal Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      The large-scale phase IV study aims to verify the safety and efficacy of apatinib in patients
      with advanced gastric cancer or gastroesophageal junction adenocarcinoma after failure of two
      lines of chemotherapy. Apatinib initiated at a recommended dose of 850mg. However, the
      starting dose was decided by investigator's choice based on patients' condition. Dose
      interruption and dose reduction were allowed according to the product label. Treatment
      continued until disease progression, intolerable toxicity, withdrawal of informed consent, or
      at investigators' discretion. The primary endpoint was safety, which was assessed by
      recording the incidence and severity of adverse events.
    


Intervention name(s): ApatinibTablets
Intervention type(s): Drug
Intervention description(s): Apatinib Tablets, recommended dose of 850mg
Intervention model: Single Group Assignment
Intervention model description: A large-scale single-arm phase IV study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Advanced; Metastatic
Clinical Trials of Regeneration for Periodontal Tissue
Condition: Adult Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Adult periodontitis is a chronic infective disease affecting the periodontium. Periodontitis
      induce the destruction of attachment apparatus of teeth, resulting in periodontal pocket
      formation and teeth loss. This study will test the safety and efficacy of alveolous bone
      reproduction by the transplantation of mixture named periodontium injectable gel for the
      adult periodontitis patients. Injectable gel is the mixture of ex-vivo cultured mesenchymal
      stem stem cells, ex-vivo cultured osteoblast-like cells differentiated from mesenchymal stem
      cells and scaffold (include, platelet rich plasma, human thrombin and calcium chloride).
    

Detailed description: 
      Periodontal disease is an infectious disease. Gingivitis and periodontitis are the 2 major
      forms of this. Their primary etiology is bacterial plaque, which can induce destruction of
      the periodontal apparatus. Gingivitis is inflammation of the gingival that does not result in
      clinical attachment loss. Periodontitis is inflammation of the gingival and is characterized
      by loss of connective tissue attachment and alveolar bone.

      Therapeutic approaches for periodontitis are divided into two categories: 1) anti-infective
      treatment; 2) regenerative therapy.

      Several surgical techniques have been developed to regenerate periodontal tissues including
      guided tissue regeneration, bone grafting, the use of enamel matrix derivative. However,
      these techniques are not reached for complete regeneration of the periodontium.

      This study will test the safety and efficacy of alveolous bone reproduction by the
      transplantation of mixture named periodontium injectable gel for the adult periodontitis
      patients. Injectable gel is the mixture of ex-vivo cultured mesenchymal stem stem cells,
      ex-vivo cultured osteoblast-like cells differentiated from mesenchymal stem cells and
      scaffold (include, platelet rich plasma, human thrombin and calcium chloride).
    

Intervention name(s): surgical operation of cell transplantation
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Regenerative medicine; Periodontal tissue
Phase 1 Study of ONT-10 in Patients With Solid Tumors
Condition: Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Open label, two part, Phase 1 dose escalation study to evaluate the safety and immunogenicity
      of repeat dose vaccination with ONT-10 in patients with previously treated Stage 3 or 4 solid
      tumors. Part 1 to evaluate escalating dose levels of ONT-10 administered subcutaneously every
      two weeks (Q2W) or weekly (QW) over 8 weeks. Part 2 evaluates the safety, immunogenicity, and
      potential anti-tumor activity of ONT-10 administered over 8 weeks at the Q2W and QW maximum
      tolerated does/recommended dose (MTD/RD) in cohorts of 15 patients each.
    

Detailed description: 
      This open label, two part, Phase 1 dose escalation study will evaluate the safety and
      immunogenicity of repeat dose vaccination with ONT-10 in patients with previously treated
      Stage 3 or 4 solid tumors with histologies that have been associated with expression of the
      MUC1 antigen as described in the medical literature. Part 1 will evaluate escalating dose
      levels of ONT-10 administered subcutaneously Q2W over 8 weeks (for a total of 4 doses) or QW
      over 8 weeks (for a total of 8 doses) to identify a MTD and/or RD for each dosing schedule,
      for further evaluation in Part 2 of the study. Part 2 will evaluate the safety,
      immunogenicity, and potential anti-tumor activity of ONT-10 administered over 8 weeks at the
      Q2W and QW MTD/RD in cohorts of 15 patients each.
    

Intervention name(s): ONT-10
Intervention type(s): Biological
Intervention description(s): ONT-10 a liposomal synthetic glycolipopeptide antigen formulated with PET Lipid A adjuvant.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ONT-10; MUC1; Vaccine; Phase 1; Solid Tumors; Dose escalation
Kineesiotaping for Patients With LCPD
Condition: Legg-Calve-Perthes Disease
MeSH terms: Legg-Calve-Perthes Disease
Study type: Interventional

Summary: 
      Kinesiotaping is increasingly being used as a complement to musculoskeletal pain management.
      This study aimed to evaluate the immediate clinical efficacy of kinesiotaping on pain and
      pain-related symptoms of Legg-Calvé-Perthes Disease (LCPD).
    

Detailed description: 
      Kinesio taping is increasingly being used as a complement to musculoskeletal pain management.
      A randomized, double-blind, placebo-controlled clinical trial was conducted. Activity-related
      hip pain, passive and pain limited hip range of motion, gluteus medius muscle strength,
      function and balance were assessed.
    

Intervention name(s): Kinesiotaping; Sham taping
Intervention type(s): Other; Other
Intervention description(s): Two I-strips were used:
The first-third of one I-strip began at the posterior iliac crest, without tension as an anchor. Then the patient actively flexed and adducted the affected hip, thus, the middle-third of the tape was applied with approximately 50% tension. Then the hip was set in its original position and the last-third of the tape ended approximately greater trochanter without tension.
The first-third of the second I-strip was applied starting at the anterior iliac crest, without tension as an anchor. The patient actively extended and adducted the affected hip, thus, the middle-third of the tape was applied with approximately 50% tension. Then the hip was set in its original position and the last-third of the tape ended approximately greater trochanter without tension.; A single I-strip without tension in tape or muscle stretch. After paper backing was completely removed, tape was essentially placed on the skin across the lateral side of the hip.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Kinesiotape; Taping; Pediatric pain; Hip joint; Physiotherapy
Safety and Tolerability Study of REGN846 (SAR302352) in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to assess the safety and tolerability of a single ascending
      intravenous (IV) dose of REGN846 in healthy volunteers.
    


Intervention name(s): REGN846
Intervention type(s): Biological
Intervention description(s): 5 IV cohorts (Dose 1, 2, 3, 4, 5)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
ED50 of Cis-atracurium for Laryngeal Mask Incubation in General Anesthesia
Condition: Urologic Diseases
MeSH terms: Urologic Diseases
Study type: Observational [Patient Registry]

Summary: 
      1. The muscle relaxants can improve the conditions of laryngeal mask incubation and reduce
           the related complications (such as laryngeal spasm and postoperative throat pain)

        2. The dosages of muscle relaxants used in various researches vary greatly.

        3. We are planning use the most classical method for determining the ED50 or half effective
           concentration of cis-atracurium using sequential method, which is also called " up and
           down method" and " ladder method".
    

Detailed description: 
      The concordance of the current research is that muscle relaxants can improve the conditions
      of laryngeal mask incubation and reduce the related complications (such as laryngeal spasm
      and postoperative throat pain ) of laryngeal mask incubation. It is necessary to use muscle
      relaxants in laryngeal mask incubation under non-special circumstances. However, the dosages
      of muscle relaxants used in various researches vary greatly of normal endotracheal
      intubation. Previous studies have shown that the amount of muscle relaxant required for
      laryngeal mask intubation is smaller than that required for endotracheal intubation. Although
      the dosage of muscle relaxant required for tracheal intubation can ensure the smooth
      insertion of laryngeal mask airway, laryngeal mask airway is mostly used for short surgery,
      which is prone to postoperative muscle relaxation residue and prolongs the recovery. We
      planning use the most classical method for determining the ED50 or half effective
      concentration of cis-atracurium using sequential method, which is also called " up and down
      method" and " ladder method".
    

Intervention name(s): Cis-atracurium
Intervention type(s): Drug
Intervention description(s): Different concentration of cis-atracurium
Other intervention name(s): muscle relaxants
Intervention MeSH terms: Atracurium; Cisatracurium
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients in Xuanwu Hospital for elective short urological surgery are selected.

        One day before surgery, visitors recorded basic information such as the patient's sex, age,
        BMI, ASA grade in the ward, carried out airway evaluation, and recorded the mouth opening
        to make sure they can be included
Effect of Age on the Median Effective Dose(ED50) for Motor Block With Intrathecal Ropivacaine
Condition: Anesthesia
Study type: Observational

Summary: 
      The primary aim of this study was to determine the median effective dose (ED50) for motor
      block of intrathecally-administered ropivacaine in adults (20-80 years), and to assess the
      effect of age on ED50 required for motor block.
    

Detailed description: 
      This study was performed in adult patients undergoing transurethral, urological or lower limb
      surgery under combined spinal and epidural anesthesia. Patients were stratified according to
      age: 20-30, 31-40, 41-50, 51-60, 61-70, and 71-80 years. The spinal component of the
      anesthetic was established by bolus administration of various up-and-down doses of 0.75%
      ropivacaine, determined by Dixon's method, with the first patient receiving 15 mg, and with
      testing intervals of 1.5 mg according to failure or success of the preceding patient's motor
      block. The degree of motor block after intrathecal administration of each dose was evaluated
      by the modified Bromage and Hip motor function score. The primary outcome was obtained by
      administration of the mean dosage that was determined from the midpoints of all independent
      pairs of patients involving a crossover from failure to success during 5 minutes after the
      spinal injection. The ED50 were estimated from the up-and-down sequences using the method of
      Dixon and Massey and logistic regression. Other endpoints were included on the basis of
      sensory block level, duration of motor blockade, hypotension, and vasopressor requirements.
    

Intervention name(s): age
Intervention type(s): Other
Intervention description(s): subjects stratified according to age: 20-30 years (Group 1), 31-40 years (Group 2), 41-50 years (Group 3), 51-60 years (Group 4), 61-70 years (Group 5), and 71-80 years (Group 6).
Sampling method: Non-Probability Sample
Study population: 
        Adult patients who were undergoing transurethral, urological or lower limb surgery,
        primarily under the spinal anesthesia
      
Keywords: intrathecal; ropivacaine; motor blockade; local anesthetics