bioihbjkbjnl/mcl2 huggingface dataset:
Phase I Study of KN035 in Chinese Subjects With Advanced Solid Tumors
Condition: Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This dose escalation and dose expansion study is to evaluate and characterize the
      tolerability and safety profile of single agent KN035 in Chinese adult subjects with
      unresectable advanced carcinoma.
    

Detailed description: 
      Dose escalation study is to evaluate the safety and tolerability of KN035 in advanced and
      metastatic solid tumor. Six dose levels are planned and include: 0.1, 0.3, 1.0, 2.5, 5, 10
      mg/kg/dose. Subjects will be assigned to a dose level in the order of study entry. The first
      cohort of 1 subject will receive KN035 at 0.1 mg/kg/dose as a subcutaneous (sc) injection
      every week for a total of 4 injections (Days 1, 8, 15 and 22) in the first 28-day cycle. For
      the first 2 cohorts (0.1 and 0.3 mg/kg/dose), only one subject will be enrolled in each
      cohort until 1 subject experiences a ≥ Grade 2 drug-related adverse event in the first cycle,
      then 2 additional subjects will be enrolled at this cohort. Thereafter, the study will become
      the traditional 3+3 design with 3 or 6 subjects treated at this dose level and all subsequent
      dose levels depending upon the incidence of DLTs. However, if no ≥ Grade 2 drug-related
      adverse event occurs in the first 2 cohorts, starting with cohort 3, the study will become
      the traditional 3+3 design with 3 or 6 subjects enrolled.

      Dose expansion-1 study is planned to conduct in advanced hepatocellular cancer subjects at
      2.5 mg/kg and 5 mg/kg dose level, respectively.

      Dose expansion-2 study is planned to conduct in advanced solid tumor subjects at 2.5 mg/kg
      and 5 mg/kg dose level, respectively
    

Intervention name(s): KN035
Intervention type(s): Drug
Intervention description(s): KN035 is a monoclonal antibody drug which is formulated for subcutaneous injection in a single-use vial (brown neutral borosilicate) containing a total of 300 mg antibody in 1.5 ml of solution.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: KN035; phase 1
Feasibility Study of the Online High School Media Aware Program
Condition: Sexual Behavior
Study type: Interventional

Summary: 
      This is a pretest-posttest feasibility study of Media Aware Sexual Health - High School, an
      interactive web-based comprehensive sexual health media literacy education program for high
      school students. The program is designed to develop students' critical thinking skills and
      promote sexual health. It is hypothesized that this program will enhance adolescents' media
      literacy skills, sexual health knowledge, cognitions (i.e., attitudes, self-efficacy, and
      norms), and behaviors regarding healthy sexual decision-making.
    


Intervention name(s): Media Aware Sexual Health - High School
Intervention type(s): Behavioral
Intervention description(s): Media Aware Sexual Health is a web-based comprehensive sexual health education program for high school students that uses a media literacy approach.
Other intervention name(s): Media Aware
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Pilot Study of a Trauma-Sensitive Mindfulness and Compassion Intervention
Condition: Complex Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Observational

Summary: 
      This mixed-methods pilot study aim to assess the changes in symptoms of post-traumatic stress
      disorder (PTSD), complex post-traumatic stress disorder (CPTSD), dissociative symptoms,
      self-critique, and self-compassion following participation in a 16-week trauma-sensitive
      mindfulness and compassion (TMC) intervention. Adverse experiences of participation are also
      explored explicitly.
    

Detailed description: 
      Seventeen clients most female with severe childhood abuse and PTSD and CPTSD participated in
      the TMC intervention. A mixed-methods design was used. All clients completed questionnaires
      before (pre) and after (post) the intervention to gain information on symptom change,
      self-critique, and self-compassion. Second, a qualitative interview addressing clients'
      experiences of participation, including an explicit focus on adverse experiences, was
      conducted.
    

Intervention name(s): TMC Treatment Approach
Intervention type(s): Other
Intervention description(s): The TMC approach consists of 16 weekly group sessions, each lasting 2 hours. The first 10 sessions focus mainly on building mindfulness capacities, and the last 6 sessions on developing compassion toward self and others. Between sessions, participants are encouraged to do exercises with the support of audio files. The approach was developed with a transdiagnostic perspective, including clients with a variety of trauma-related symptoms.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The inclusion criteria in each group were in accordance with the institution's clinical
        practice
      
Keywords: mindfullness; treatment; compassion; trauma
An Investigation Of The Interaction Of GSK961081 With Inhaled Beta-Agonist And Anti-Muscarinic Drugs.
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      GSK961081 is a potent dual pharmacophore that demonstrates both antimuscarinic and
      beta-agonist pharmacology in preclinical studies, both pharmacologies being of long duration.
      If reproduced in man, GSK961081 has the potential to deliver a medicine that can be given
      once daily. The bronchodilatation after inhalation of single doses of GSK961081 alone and in
      the presence of the short acting beta agonist salbutamol and the short acting muscarinic
      antagonist, ipratropium bromide will be measured in this study. Any residual
      bronchodilatation post-inhalation of GSK961081 and demonstrated by addition of salbutamol or
      ipratropium bromide may provide an indirect assessment of the beta-agonist and antimuscarinic
      components of GSK961081
    

Detailed description: 
      GSK961081 is a potent dual pharmacophore that demonstrates both antimuscarinic and
      beta-agonist pharmacology in preclinical studies, both pharmacologies being of long duration.
      If reproduced in man, GSK961081 has the potential to deliver a medicine that can be given
      once daily. The bronchodilatation after inhalation of single doses of GSK961081 alone and in
      the presence of the short acting beta agonist salbutamol and the short acting muscarinic
      antagonist, ipratropium bromide will be measured in this study. Any residual
      bronchodilatation post-inhalation of GSK961081 and demonstrated by addition of salbutamol or
      ipratropium bromide may provide an indirect assessment of the beta-agonist and antimuscarinic
      components of GSK961081
    

Intervention name(s): 400 microgrammes GSK961081; 1200 microgrammes GSK961081
Intervention type(s): Drug; Drug
Intervention description(s): Inhaled GSK961081 administered via Dry Powder Inhaler.; Inhaled GSK961081 adminisntered via dry powder inhaler.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: salbutamol,; Chronic Obstructive Pulmonary Disease (COPD); GSK961081 muscarinic receptor antagonist,; COPD; ipratropium bromide,; Asthma; ß2-adrenergic agonist,
Dexamethasone and Etoricoxib for Pain Prevention Following Periodontal Surgery
Condition: Pain Control
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to investigate whether preemptive medication with dexamethasone
      or etoricoxib provides better pain management and control than placebo following periodontal
      surgery.
    


Intervention name(s): Open Flap Debridement
Intervention type(s): Procedure
Intervention description(s): Open flap debridement - access flap + scaling and root planning
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pain; pain assessment
Acs-Tens Treatment for Faecal Incontinence: a RCT With Sham-controls
Condition: Faecal Incontinence; Faecal Incontinence With Faecal Urgency; Neuromodulation; Transcutaneous Electric Nerve Stimulation; Acupuncture Points
MeSH terms: Fecal Incontinence
Study type: Interventional

Summary: 
      This study assess the effectiveness on AcuTENS on the treatment of faecal incontinence
    

Detailed description: 
      Faecal incontinence (FI) is the involuntary loss of flatus, liquid or solid stool per rectum.
      Owing to the emotional stress and the psychosocial stigma surrounding this problem, it is
      under-reported by patients.

      Conservative management of FI involves lifestyle, medical adjustments and pelvic floor
      sphincter training. If conservative treatment fails, surgical options such as sphincter
      repair, sacral nerve stimulation (SNM) and percutaneous tibial nerve stimulation (PTNS) can
      be reformed. SNM and PTNS involve application of nervous electrical stimulation
      (neuromodulation) with significant improvement of symptoms. The positions of electrical
      stimuli are also very similar to acupuncture sites (acupoints) used in Traditional Chinese
      Medicine for the treatment of faecal incontinence. However, disadvantage of these methods
      are; 1) they are invasive and may cause complications such as pain, infection and bleeding
      and; 2) the devices for each SNM device can be costly.

      Transcutaneous Electrical Nerve Stimulation (TENS) is non-invasive, which is commonly used
      for the management of pain. It works via the application of electrical stimuli using adhesive
      gel pads. They are cheap to run and are widely accepted by patients. Hence application of
      TENS over acupoints (Acu-TENS) may provide a novel non-invasive treatment.

      A randomised controlled trial will be carried out on patients with FI. Demographic data, past
      medical history, in particular any structural or neurological causes of FI, will be recorded.
      Ano-rectal manometry and endoanal ultrasound will be performed before and after treatment.
      Acu-TENS machine will be applied to standardised acupuncture points. Assessment of FI via
      Cleveland Clinic Florida Faecal Incontinence Score and Quality of life measurements via the
      validated questionnaires Short Form 36 (SF-36) and the Fecal Incontinence Quality of Life
      Scale (FIQL) (Chinese version) questionnaires will be carried out at baseline, and followup
      intervals.
    

Intervention name(s): AcuTENS
Intervention type(s): Procedure
Intervention description(s): Stimulation of acupuncture points with TENS machine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Acutens treatment for faecal incontinence vs sham
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Faecal incontinence; Faecal urgency; Neuromodulation; Transcutaneous Electric Nerve Stimulation; Acupuncture
Study Of Atopic Dermatitis In Pediatrics
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      To verify of cetirizine dry syrup to ketotifen dry syrup in the change in the severity of
      pruritus of the treatment period.
    


Intervention name(s): Cetirizine Dry Syrup
Intervention type(s): Drug
Intervention MeSH terms: Cetirizine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Atopic; Pediatric; Dermatitis
A Descriptive Study to Explore Certain Characteristics of Patients at Risk for Chronic Obstructive Pulmonary Disease (COPD) in a Primary Care Setting
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      The purpose of this study is to explore if certain characteristics, easily detected within a
      regular primary care setting, may indicate that a patient at risk for COPD (45 ≤ age ≤ 80
      years and a smoking history of ≥ 15 pack years) is prone to have a diagnosis of COPD
      according to Medical Products Agency guidelines.
    


Sampling method: Non-Probability Sample
Study population: 
        Primary care clinic
      
Keywords: COPD; COPD-6; Spirometry; VC; FEV; FEV1
Lamivudine Therapy in Patients With Prior Entecavir Treatment and Undetectable Viral Load
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis B; Hepatitis B, Chronic
Study type: Interventional

Summary: 
      Patients with chronic hepatitis B and treated with entecavir for over 6 months (with no
      previous other antiviral treatment) will be invited to participate in this study. They will
      be eligible if their liver tests are normal and their viral load is undetectable. Patients
      will be switched to lamivudine treatment to assess whether lamivudine can maintain adequate
      suppression of the hepatitis B virus after successful treatment with entecavir. Patients will
      be monitored closely after switching treatment at 1 months and then every 3 monthly. If there
      is any evidence of increase in viral load then patients will be given the option of changing
      back to entecavir.
    


Intervention name(s): Entecavir; Lamivudine
Intervention type(s): Drug; Drug
Intervention description(s): Entecavir 0.5mg orally daily; Lamivudine 100mg orally, daily
Other intervention name(s): Baraclude; Zeffix
Intervention MeSH terms: Lamivudine; Entecavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: entecavir; lamivudine; sequential therapy
Study of Vorinostat (MK-0683) With Follicular Lymphoma (FL), Other Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL), or Mantle Cell Lymphoma (MCL) Participants (MK-0683-103)
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Lymphoma, Mantle-Cell; Lymphoma, B-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and efficacy of vorinostat
      (MK-0683) in participants with relapsed and/or refractory follicular lymphoma. The
      exploratory purpose of this study is to evaluate efficacy of MK-0683 in participants with
      relapsed/refractory non-FL indolent B-NHL or relapsed/refractory MCL. The primary hypothesis
      is that MK-0683 will show efficacy in relapsed/refractory FL patients as measured by the
      Overall Response Rate.
    


Intervention name(s): Vorinostat
Intervention type(s): Drug
Intervention description(s): Two 100 mg oral capsules of vorinostat, twice daily (400 mg/day), on Days 1 through 14 of each 21 day cycle
Other intervention name(s): MK-0683; Zolinza
Intervention MeSH terms: Vorinostat
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: All participants received the same drug regimen but were allocated to groups based on disease type.
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Dexmedetomidine for Emergence Cough
Condition: Cough
MeSH terms: Cough
Study type: Interventional

Summary: 
      Dexmedetomidine or remifentanil are effective in attenuating cough during peri-extubation
      period after general anesthesia. The purpose of this study was to investigate the effect of
      dexmedetomidine on the remifentanil concentration for the cough suppression during anesthetic
      emergence.
    

Detailed description: 
      Administration of dexmedetomidine before end of surgery could reduce airway reflexes and
      hemodynamic changes during tracheal extubation. Compared with remifentanil alone,
      administration of dexmedetomidine in combination with remifentanil is effective in relieving
      cough and hemodynamic changes without inhibition of respiration. The purpose of this study
      was to investigate the effect of dexmedetomidine on the remifentanil concentration for the
      cough suppression during anesthetic emergence using the modified up-and-down method.
    

Intervention name(s): Dexmedetomidine; Remifentanil; Normal saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dexmedetomidine 0.5mcg/kg was infused over 10 min before end of the surgery; Remifentanil was maintained at predetermined effect-site concentration during the periextubation period (initial concentration: 2.0 ng/ml); Normal saline was infused over 10 min before end of the surgery
Other intervention name(s): Prededex; Ultiva; 0.9% NaCl
Intervention MeSH terms: Dexmedetomidine; Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Prevention
Keywords: dexmedetomidine; remifentanil; extubation
A Multicenter Phase I Study Evaluating the Addition of Bortezomib to an Established Acute Graft Versus Host Disease Prophylaxis Regimen in Pediatric Allogeneic Hematopoietic Stem Cell Transplant Patients
Condition: Hematopoetic Stem Cell Transplant
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to determine the maximum tolerated dose (MTD) of bortezomib in
      combination with calcineurin inhibitor and methotrexate as acute graft versus host disease
      (aGVHD) prophylaxis in pediatric patients undergoing allogeniec hematopoietic stem cell
      transplant (alloHSCT)
    


Intervention name(s): Bortezomib administration
Intervention type(s): Drug
Intervention MeSH terms: Bortezomib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Impact of Fingolimod Adherence on Outcomes
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Observational

Summary: 
      This study was a retrospective observational claims data study of commercial and Medicare
      Advantage with Part D (MAPD) patients initiating fingolimod.
    

Detailed description: 
      The study sample comprised commercial and MAPD enrollees who initiated fingolimod treatment
      during the identification period of 01 January 2012 through 10 May 2018. The date of the
      first fingolimod pharmacy claim during the identification period was the index date.

      All patients were continuously enrolled in the health plan for 24 months. The 6-month
      pre-index period, ending the day before the index date, was used to assess patients' clinical
      characteristics (e.g., comorbid conditions and MS symptoms). The 18-month post-index period
      started on the index date. The first 6 months of the post-index period (initiation period)
      were used to assess MS symptoms and adherence. Months 7 - 18 of the post-index period
      (post-initiation period) were used to measure adherence and outcomes. The 24-month
      observation period for each patient comprised the 6-month pre-index and 18-month post-index
      periods.
    

Intervention name(s): Fingolimod
Intervention type(s): Drug
Intervention description(s): Participants who initiated fingolimod to treat multiple sclerosis (MS)
Intervention MeSH terms: Fingolimod Hydrochloride
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study comprised of commercial and Medicare Advantage with Part D (MAPD) enrollees who
        initiated fingolimod treatment during the identification period of 01 January 2012 through
        10 May 2018.
[KSR-001-P01]Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristic of KSR-001
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic
      characteristic of KSR-001.
    

Detailed description: 
      After single dose, safety and local tolerability were confirmed and repeated test was
      conducted according to the investigator's judgment.
    

Intervention name(s): KSR-001; KSR-004; KSR-001-02; KSR-001-03
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): (0 day) eye drops received one drop to both eyes once a day (1~5 day) eyedrops recieved one drop to both eyes four times a day; (0 day) eye drops received one drop to both eyes once a day (1~5 day) eyedrops recieved one drop to both eyes four times a day; KSR-001-02; KSR-001-03
Other intervention name(s): KSR-001-01
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Ropeginterferon Alfa-2b (P1101) Phase 3 Study in Interferon Treatment-Naive Subjects With HCV Genotype 2 Infection
Condition: Chronic Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C; Hepatitis C, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective:

      To demonstrate non-inferiority in sustained virologic response (SVR, undetectable HCV RNA at
      Follow up week 12) between PEG-Intron 1.5 µg per kg SC Q1W + Ribavirin 800-1400 mg PO daily
      and P1101 400 µg SC Q2W + Ribavirin 800-1400 mg PO daily for the treatment of chronic HCV
      genotype 2 infection
    

Detailed description: 
      Secondary objective:

      To determine and compare the efficacy, safety, tolerability and immunogenicity of PEG-Intron
      1.5 µg per kg SC Q1W + Ribavirin 800-1400 mg PO daily and P1101 400 µg SC Q2W + Ribavirin
      800-1400 mg PO daily
    

Intervention name(s): P1101 + Ribavirin; PEG-Intron + Ribavirin
Intervention type(s): Drug; Drug
Intervention description(s): P1101 400 µg SC Q2W + Ribavirin 800-1400 mg PO daily; PEG-Intron 1.5 µg per kg SC Q1W + Ribavirin 800-1400 mg PO daily
Other intervention name(s): Ropeginterferon alfa-2b; Peginterferon alfa-2b
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: P1101; HCV; PEG-Intron