bioihbjkbjnl/mcl2 huggingface dataset:
First-in-Human (FIH) Clinical Study of NM8074 in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 randomized, double-blind, placebo-controlled, single administration,
      sequential cohort with sentinel dosing, dose escalation study designed to evaluate the
      safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of NM8074 in
      healthy subjects. This study will include 5 cohorts, with each cohort consisting of a total
      of 8 healthy subjects, including both males and females, randomized in a 3:1 ratio of NM8074
      to placebo (6 subjects assigned to NM8074 and 2 subjects assigned to placebo).
    

Detailed description: 
      NM8074 is a novel, recombinant, humanized monoclonal antibody. NM8074 selectively binds to
      human Factor Bb with high affinity and blocks the formation of Alternative Pathway (AP)
      driven C3 and C5 convertases. Both C3 and C5 convertases are critical for exacerbation and
      amplification of the AP in complement-mediated disorders. 06-101-FIH-NM8074 is the
      first-in-human clinical trial for NM8074 which is intended to evaluate the safety,
      tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of NM8074 when delivered
      as a single intravenous infusion to healthy volunteers. Doses will be escalated in each of
      the 5 sequential cohorts using sentinel dosing.
    

Intervention name(s): NM8074; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Novel, recombinant, humanized monoclonal antibody that selectively binds to human Factor Bb with high affinity and blocks the formation of Alternative Pathway (AP) driven C3 and C5 convertases; Saline Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Eligible subjects who meet the inclusion/exclusion criteria will be randomized on Day 1 to either NM8074 or placebo. The sentinel pair in each of the 5 dose cohorts will be randomized in a 1:1 ratio to receive NM8074 or placebo. The remaining subjects will be randomized in a 5:1 ratio to NM8074 to placebo. Dose escalation will occur in sequential cohorts once safety has been evaluated in the prior cohort.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison of Efficacy of Anesthesia Administered by Endoscopist or Anesthesiologist on Colonoscopy
Condition: Colonoscopy; Ketamine; Fentanyl
Study type: Observational

Summary: 
      In sedation applications performed by an endoscopist or anesthetist during colonoscopy, it
      was investigated whether there were differences in pain levels evaluated by VAS (Visuel
      analog scale), patient satisfaction, duration of procedure and side effects
    

Detailed description: 
      Gastrointestinal endoscopes are an invasive and unpleasant procedure that is increasingly
      being performed worldwide (1). Colonoscopy; is one of the endoscopic procedures that can be
      used to diagnose and treat large intestine and cause pain and excessive discomfort in the
      patient (2). For this reason, intravenous (iv) sedative agents are used in endoscopy centers
      where endoscopy will be performed. However, side effects such as hypoxia and hypotension,
      which are usually dose-dependent, caused by these sedative agents, play an important role
      among risk factors associated with colonoscopy (3). For this reason, the use of propofol as
      an anesthetic is prohibited in some countries, which is a commonly used agent for sedation.
      However, the presence of an anesthetist during each endoscopy procedure is difficult because
      there are not enough anesthetists. This application is also more costly. For this reason,
      studies have been carried out during the gastrointestinal endoscopy when sedation is
      delivered by someone other than the anesthetist (4). For this purpose, several studies
      comparing patient-controlled sedation or sedation applied by an endoscopist to sedation
      performed by anesthesiologist were performed (4, 5). Investigators aimed to investigate
      whether there is any difference between the two groups in terms of pain levels assessed by
      VAS (Visuel analog scale) and patient satisfaction by comparing sedation protocols applied by
      endoscopist or anesthesist during colonoscopy in this study.
    

Intervention name(s): Ketamine; fentanyl; patient control analgesia
Intervention type(s): Drug; Drug; Device
Intervention description(s): sedation drugs; sedation drugs; patient control analgesia
Intervention MeSH terms: Fentanyl; Ketamine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        colonoscopy patients with ASA I-II group
Peginterferon Plus Ribavirin for Hepatitis C Patients Concomitant With Malignancy Other Than Hepatocellular Carcinoma
Condition: Chronic Hepatitis C; Neoplasms
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Carcinoma, Hepatocellular; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      Combination therapy with pegylated interferon-alpha plus ribavirin has greatly improved the
      treatment efficacy and is the mainstream of treatment for chronic hepatitis C infection. The
      efficacy and safety of pegylated interferon-alpha plus ribavirin combination therapy and its
      impact on the outcome in chronic hepatitis C patients concomitant with malignancy other than
      hepatocellular carcinoma deserve to be elucidated.

      The purposes of this study are:

        1. To evaluate the efficacy and safety of pegylated interferon-alpha 2a plus ribavirin
           combination therapy in chronic hepatitis C patients concomitant with malignancy other
           than hepatocellular carcinoma, compare to those without systemic malignancy.

        2. To investigate the role of baseline and on-treatment factors on the response to
           pegylated interferon-alpha 2a plus ribavirin combination therapy in chronic hepatitis C
           patients concomitant with malignancy other than hepatocellular carcinoma.
    

Detailed description: 
      A prospective, hospital-based study enrolling 40 chronic hepatitis C patients concomitant
      with malignancy other than hepatocellular carcinoma and other sex- and age-matched 80 chronic
      hepatitis C patients without malignancy will be conducted. The 40 chronic hepatitis C
      patients concomitant with malignancy other than hepatocellular carcinoma will receive
      pegylated interferon-alpha 2a plus ribavirin combination therapy at remission phase after
      oncological treatments and/or interventions. The other 80 chronic hepatitis C patients
      without malignancy receiving the same antiviral therapy will serve as controls. The primary
      outcome measurement is sustained virological response and safety, whilst the secondary
      measurement is rapid virological and early virological response.
    

Intervention name(s): pegylated interferon alpha 2a and plus ribavirin; pegylated interferon alpha 2a and plus ribavirin
Intervention type(s): Drug; Drug
Intervention description(s): pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up for 24 weeks; pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up for 24 weeks
Other intervention name(s): PEGASYS®; PEGASYS®
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic hepatitis C; sustained virological response; peginterferon; ribavirin; neoplasms
Bioavailability Study of K0706 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is single-center, single-dose, randomized, open-label, four-period, four sequence
      crossover study to evaluate the relative bioavailability of K0706 24 mg tablet formulation
      relative to 24 mg capsule formulation under fasted conditions and to evaluate the food-effect
      for tablet formulation in healthy subjects.
    


Intervention name(s): K0706; K0706
Intervention type(s): Drug; Drug
Intervention description(s): Study treatment with water after an overnight fast; Study treatment with water after food
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
INC280 in Healthy Subjects With Impaired Hepatic Function and Subjects With Normal Hepatic Function
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, multi-center, open-label, single oral dose, parallel group study to
      evaluate the pharmacokinetics and safety of INC280 in non-cancer subjects with impaired
      hepatic function and non-cancer subjects with normal hepatic function.The study population
      will be healthy male and postmenopausal or sterile female subjects who meet all of the
      inclusion and none of the exclusion criteria. Subjects will be assigned to groups according
      to their hepatic function: normal (Group 1), mild (Group 2), moderate (Group 3), and severe
      (Group 4) impairment. This study consists of a two-staged design with interim analysis. In
      Stage 1, subjects in Groups 1, 2 and 3 will be enrolled. Upon completion of Stage 1, an
      interim analysis will be conducted. Depending on the results of the analysis, either the
      study will conclude with no further enrollment or Stage 2 will commence with enrollment of
      Group 4.

      A minimum of 6 evaluable subjects per group will be enrolled.Once enrolled in the study,
      participants will be confined to the facility for 4 days, given a single dose of INC280 and
      monitored for pharmacokinetic and safety assessments.
    


Intervention name(s): INC280
Intervention type(s): Drug
Intervention description(s): Single 200 mg dose INC280
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatic impairment,; INC280,; Oral cMET Inhibitor,; Non-Cancer
Mesenchymal Stem Cells in the Treatment of Relapsed/Refractory Severe Acquired Aplastic Anemia
Condition: Aplastic Anemia
MeSH terms: Anemia; Anemia, Aplastic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Mesenchymal stem cells have been tested in many autoimmune disorders with encouraging results
      and may be an alternative to the treatment of immune-mediated severe acquired aplastic
      anemia.
    

Detailed description: 
      Acquired aplastic anemia is a bone marrow failure syndrome characterized by and empty bone
      marrow and low blood counts. Most of the cases are immune-mediated. Allogeneic bone marrow
      transplant is the preferable treatment modality for patients younger than 40 years with a
      matched sibling donor. Patients not eligible for transplant are treated with intensive
      immunosuppressive therapy often based on anti-thymocyte globulin and cyclosporine.

      However, up to one third of patients treated with immunosuppression are refractory and one
      third of those who response eventually relapse. Refractory and relapsed cases may be the
      result of insufficient immunosuppression and these cases may benefit from additional
      immunosuppression. Mesenchymal stem cells infusion may be a potential treatment option,
      considering its properties to modulate the immune system.

      Refractory or relapsed patients with aplastic anemia will be treated with conventional
      immunosuppressive regimen (anti-thymocyte globulin plus cyclosporine) combined with
      intravenous infusion of allogeneic unrelated bone marrow mesenchymal stem cells.
    

Intervention name(s): Intravenous bone marrow mesenchymal stem cells infusion
Intervention type(s): Biological
Intervention description(s): After standard immunosuppressive therapy with rabbit antithymocyte globulin 3,5 mg/Kg/day during 5 days, allogeneic unrelated bone marrow derived mesenchymal stem cells will be infused intravenously. Oral cyclosporine 5 mg/Kg/day (with dose correction weekly to keep serum cyclosporine level between 150-250 mg/dl) up to 6 months will be added.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aplastic Anemia; Mesenchymal Stem Cells
A Phase 1 Study to Evaluate Safety & Immunogenicity of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects
Condition: Nipah Virus Infection
MeSH terms: Henipavirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1 Study to Evaluate the Safety and Immunogenicity of rVSV-Nipah Virus Vaccine
      Candidate PHV02 in Healthy Adult Subjects
    

Detailed description: 
      A Phase 1 Randomized, Single Center, Double-Blind, Placebo-Controlled, Dose-Response Study to
      Evaluate the Safety and Immunogenicity of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy
      Adult Subjects
    

Intervention name(s): PHV02; Placebo
Intervention type(s): Biological; Other
Intervention description(s): live, recombinant virus consisting of vesicular stomatitis virus (VSV; Indiana) with the gene for the Zaire ebolavirus glycoprotein (GP) (EBOV GP) replacing the gene for the VSV GP; in addition, the Nipah virus (NiV) G protein is also inserted and expressed. The vaccine is administered as a single intramuscular injection; Lactated Ringer's Solution. The placebo will be administered as a single intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: henipavirus; vesicular stomatitis vector; paramyxoviridae infection; zoonotic disease
Combination of Cryosurgey and NK Immunotherapy for Recurrent Cervical Cancer
Condition: Recurrent Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to
      recurrent cervical cancer.
    

Detailed description: 
      By enrolling patients with recurrent cervical cancer adapted to enrolled criteria, this study
      will document for the first time the safety and the short and long term efficacy of the
      combined therapy using cryosurgery and natural killer (NK) cells.

      The safety will be evaluated by statistics of adverse reactions. The efficacy will be
      evaluated according to local relief degree, progress free survival (PFS) and overall survival
      (OS).
    

Intervention name(s): Cryosurgery; NK immunotherapy
Intervention type(s): Device; Biological
Intervention description(s): Percutaneous ablation under CT or ultrasound guidance; Each treatment: 8~10 billion cells in all, transfuion in 3 times, i.v.
Other intervention name(s): Argon-helium cryosurgical system
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cervical Cancer; cryosurgery; NK immunotherapy
A Study to Evaluate the Safety and Antiviral Effect of Multiple Doses of ABT-493 and ABT-530 in Adults With Genotype 1 Hepatitis C Virus (HCV)
Condition: Chronic Hepatitis C; Hepatitis C Virus; Compensated Cirrhosis
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and antiviral effect of multiple doses of
      ABT-493 and ABT-530 in adults with genotype 1 HCV.
    


Intervention name(s): ABT-493; ABT-530; ABT-450/r/ABT-267, ABT-333; Ribavirin (RBV)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablet; Tablet; Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet; Tablet
Other intervention name(s): glecaprevir; pibrentasvir; ABT-267 also known as ombitasvir; ABT-450 also known as paritaprevir; ABT-333 also known as dasabuvir; Viekira PAK
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Hepatitis C; Cirrhosis; Child Pugh A; Hepatitis C virus; Compensated Cirrhosis; Hepatitis C Genotype 1; Hepatitis C; Interferon-Free; Cirrhotic
Genetic Identification of Monogenic Disorders in Early-onset Stroke Using Targeted Next Generation Sequencing Panel
Condition: Stroke, Acute; Transient Ischemic Attack; Single-gene Disorders
MeSH terms: Stroke; Ischemic Attack, Transient
Study type: Observational

Summary: 
      The study was designed as a multicenter multiracial prospective observational study of acute
      ischemic stroke and TIA patients across china. The purpose of this study is to determine the
      monogenic disorders incidence of Chinese early-onset stroke patients. We plan to
      consecutively enroll more than 500 patients with early-onset stroke(in the 18- to 45-year age
      range) admitted in stroke units within 7 days after symptoms onset in participating centers.
      These early-onset stroke patients are referred for targeted sequencing using 'cerebrovascular
      disease panel'. By analyzing the sequencing results, we intend to identify monogenic causes
      causing early-onset stroke and develop clinical algorithms that might assist the clinician in
      deciding in which early-onset stroke patients testing for monogenic causes of stroke.
    

Detailed description: 
      The study was designed as a multicenter multiracial prospective observational study of acute
      ischemic stroke and TIA patients across china. The purpose of this study is to determine the
      monogenic disorders incidence of Chinese early-onset stroke patients. We plan to
      consecutively enroll more than 500 patients with early-onset stroke(in the 18- to 45-year age
      range) admitted in stroke units within 7 days after symptoms onset in participating centers.
      Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be
      referred for targeted sequencing using 'cerebrovascular disease panel'. When one or multiple
      pathogenic or possible pathogenic exonic mutations are found, a Sanger Sequencing (SS) on
      somatic DNA from peripheral blood leukocyte of the index case and affected relatives will be
      performed for the screening of the same mutations. And the sporadic patient's mutations will
      be checked by SS in the unaffected family members. By analyzing the sequencing results, we
      intend to identify monogenic causes causing early-onset stroke and develop clinical
      algorithms that might assist the clinician in deciding in which early-onset stroke patients
      testing for monogenic causes of stroke.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Acute ischemic stroke or Transient ischemic attack patients from participating centers over
        China that can be enrolled within 7 days of symptoms onset defined by the"last see
        normal"principle.Female or male aged ≥ 18 years and ≤ 45 years.
      
Biospecimen description: 
      Genomic DNA was extracted from peripheral blood leukocytes,
    
Keywords: Stroke; Transient Ischemic Attack; Targeted sequencing panel; Early-onset
First in Human of Single and Multiple Doses of MOR106
Condition: Healthy; Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, dose-escalation, phase I study for
      the assessment of safety, tolerability and pharmacokinetics of single ascending doses of
      MOR106 in healthy male subjects and multiple ascending doses in subjects with moderate to
      severe atopic dermatitis.
    


Intervention name(s): MOR106 single ascending doses, intravenous; Placebo single ascending doses, intravenous; MOR106 multiple ascending doses, intravenous; Placebo multiple intravenous administrations
Intervention type(s): Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Assess the Influence of Three Different α-antagonists and Placebo on the Extent of Weekly Phenylephrine-induced Mydriasis at Three Different Concentrations of Phenylephrine in Healthy Male Volunteers
Condition: Healthy
MeSH terms: Mydriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The study was aimed to evaluate the pharmacological effect of different α-antagonists on
      phenylephrine induced pupil size in healthy male volunteers as pharmacological basis for
      Intraoperative floppy iris syndrome (IFIS)
    


Intervention name(s): Tamsulosin; Alfuzosin; Doxazosin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Alna®; Uroxatral® uno; Cardular PP Uro®
Intervention MeSH terms: Doxazosin; Tamsulosin; Alfuzosin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Evaluating a Shortened Version of the Incredible Years (IY) Basic Programme in a Non-clinical Community Sample
Condition: Parenting Behavior; Child Behavior Problems
MeSH terms: Problem Behavior
Study type: Interventional

Summary: 
      Aim of study:

      To evaluate the effects of the shortened version of the Incredible Years (IY) Basic
      programme, the study which the parents were recruited to. A randomising experimental control
      between-group design was used with pre- and post-intervention measurements, and a one-year,
      four-year and ten-year follow-up. Children and families were randomized to either the
      shortened basic version (n = 89), or the control group (n = 97).
    


Intervention name(s): Brief Incredible Years parent training
Intervention type(s): Behavioral
Intervention description(s): The IY parent training programme (3-8 years) developed by Webster-Stratton at the Parenting Clinic, University of Washington, is a manualised and video-based training programme for parents of young children with conduct problems (Webster-Stratton and Reid, 2003a). Parents assigned to the short IY Basic (S-IY) condition were divided into groups of 10-12 parents. The S-IY was led by two experienced group leaders and parents met weekly for two-hour sessions at a public health care center in the community. The group leaders led discussions regarding central aspects of parenting on the basis of the video vignettes, role play and homework.
Other intervention name(s): The Incredible Years Programme series
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Harsh discipline; parental competence; positive parenting