bioihbjkbjnl/mcl2 huggingface dataset:
Iressa Re-Challenge in Advanced NSCLC EGFR M+ Patients Who Responded to Gefitinib USed as 1st Line or Previous Treatment
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      the primary objective is to characterise the impact of gefitinib on the Response Evaluation
      Criteria in Solid Tumours (RECIST) based assessments; objective response rate (ORR ;
      confirmed complete response(CR) or partial response (PR)) and disease control rate (DCR;
      confirmed complete response(CR) or partial response (PR) or stable disease (SD)) in patients
      with EGFR M+ NSCLC
    

Detailed description: 
      A phase II Open Label, Multicentre, Single Arm Study to Characterise the Efficacy, Safety and
      Tolerability of Gefitinib 250 mg (IRESSA�) as 3rd line treatment re-challenge in Patients,
      who have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or
      Metastatic Non-Small Cell Lung Cancer (NSCLC) and who responded to gefitinib in 1st line and
      progressed after 2nd line chemotherapy
    

Intervention name(s): Gefitinib 250mg
Intervention type(s): Drug
Intervention description(s): Gefitinib 250mg once daily
Other intervention name(s): Iressa
Intervention MeSH terms: Gefitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluating the Bioequivalence of HIP1403 and HGP0919 Suspensions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the bioequivalence after administration of
      HIP1403 and HGP0919 suspensions in healthy male volunteers.
    

Detailed description: 
      A randomized, open-label, single dose, crossover clinical trial to investigate and compare
      the pharmacokinetics between HIP1403 and HGP0919 suspensions in healthy male volunteers.
    

Intervention name(s): HIP1403; HGP0919
Intervention type(s): Drug; Drug
Intervention description(s): Oseltamivir 6mg/mL; Oseltamivir phosphate 6mg/mL
Other intervention name(s): Oseltamivir 6mg/mL; Tamiflu Oral Suspension 6mg/mL
Intervention MeSH terms: Oseltamivir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Effect of Multiple Doses of Itraconazole, Phenytoin, and Paroxetine on the Single-Dose Pharmacokinetics of Poziotinib in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the effect of multiple-doses of itraconazole,
      phenytoin and paroxetine on the single-dose pharmacokinetics (PK) of poziotinib in healthy
      adult participants.
    

Detailed description: 
      This is a three-part study. Participants will be enrolled in Part 1 (Effects of
      Itraconazole), Part 2 (Effects of Phenytoin), or Part 3 (Effects of Paroxetine) on the
      Pharmacokinetics of Poziotinib. Each part will be an open-label, fixed-sequence, 2-period
      study and may be conducted concurrently. For each study part, participants will be housed on
      Day -1 of Treatment Period 1 in the Clinical Research Unit (CRU) and will remain confined in
      the CRU until after the last scheduled blood draw and/or study procedures in Treatment Period
      2. In each part, there will be a washout period of at least 8 days between poziotinib doses.

      A total of 75 (25 in each part) healthy, adult male and female participants will be enrolled
      targeting a female/male ratio greater than or equal to (≥) 1:3 in each study part.

      In part 1, CYP2D6 extensive metabolizers will be primarily enrolled with a goal of enrolling
      at least 2 CYP2D6 poor metabolizers. In Parts 2 and 3, only CYP2D6 extensive metabolizers
      will be enrolled. In Part 2, CYP2C9 and CYP2C19 poor metabolizers will be excluded.
    

Intervention name(s): Poziotinib; Itraconazole; Phenytoin; Paroxetine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Poziotinib Tablets; Itraconazole Oral solution; Phenytoin Capsules; Paroxetine Tablets
Other intervention name(s): Paxil ®
Intervention MeSH terms: Itraconazole; Phenytoin; Paroxetine
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy Volunteers
Safety and Efficacy of an Inactivated and Non Adjuvanted Vaccine Against Influenza A in Renal Transplant Recipients
Condition: Renal Transplant Recipients; Immunosuppression
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is aimed at assessing the safety and efficacy of an inactivated and non adjuvanted
      Influenza A (H1N1) vaccine in renal transplant recipients.
    

Detailed description: 
      120 renal transplant recipients under triple immunosuppression will be immunized against
      influenza H1N1v.

      The primary endpoint will be the humoral immunity assessed 21 days after each injection on
      day 0 and day 21:

        -  seroprotection rate, defined as the percentage of patients with an antibody title
           against Hemaglutinin ≥ 1/40e after immunization

        -  seroconversion rate, defined as the the percentage of patients with an antibody title
           against Hemaglutinin < 1/10e before immunization and ≥ 1/40e after or with a prevaccine
           title ≥1/10e increasing at least 4 fold after immunization

        -  seroconversion factor, defined as the ratio between pre and post vaccine geometrical
           means of the antibody titles.

      Secondary endpoints will be:

        -  Seroconversion rate, seroprotection rate and seroconversion factor on day 182

        -  Percentage of patients with an antibody title > 1/40e on day 182 (Immune memory)

        -  Number and severity of clinical and biological adverse events

        -  Number of cases of pandemic H1N1v influenza virologically confirmed

        -  Study of associated parameters influencing the results of H1N1v vaccination in terms of
           seroprotection, seroconversion and seroconversion factor

        -  Assessment of the cellular immune response against H1N1v

        -  Assessment of the H1N1v vaccination on graft function and on humoral anti-HLA response.
    

Intervention name(s): inactivated non adjuvanted pandemic H1N1 vaccine
Intervention type(s): Biological
Intervention description(s): two administrations at D and D21 (15 µg HA)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: renal transplantation; immunosuppression; inflenza A (H1N1); vaccine
Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress
Condition: Alcohol Use Disorder; Stress Disorders, Post-Traumatic; Anxiety Disorders; Substance Use Disorders
MeSH terms: Substance-Related Disorders; Alcoholism; Anxiety Disorders; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether oxytocin will decrease craving to use
      drugs/alcohol and stress reactivity following exposure to laboratory-induced stress among
      Active Duty Service Members with a dual diagnosis of alcohol/substance use disorder (ASUD)
      and post-traumatic anxiety.
    

Detailed description: 
      The purpose of this study is to determine whether intra-nasally administered oxytocin will
      decrease craving to use alcohol and stress reactivity following exposure to
      laboratory-induced stress among Active Duty Service Members (AD SMs) with a dual diagnosis of
      alcohol/substance use disorder (ASUD) and post-traumatic anxiety (i.e., PTSD or anxiety
      disorder NOS).

      This is a 2-arm placebo controlled study. Subjects will complete a battery of self-report
      questionnaires and behavioral interviews. Baseline assessments of subjective (craving,
      stress), physiologic (HR, BP), and neuroendocrine measures (salivary cortisol) will be
      collected. These same assessments will be repeatedly collected throughout the testing portion
      of the study. Subjects will receive acute administration of intra-nasal oxytocin or placebo
      and will then be exposed to a laboratory-induced social stressor. They will be asked to give
      a short speech and perform arithmetic in front of a panel of judges. Following the task,
      additional post-task assessments of the subjective, physiological, and neuroendocrine
      measures will be completed over the next hour.
    

Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intranasal oxytocin 40 IU; Intranasal saline solution
Other intervention name(s): Syntocinon nasal spray
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
COL-1077 (Lidocaine Bioadhesive Gel, 10%) in Women Undergoing Transvaginal Pipelle-Directed Endometrial Biopsy
Condition: Endometrial Biopsy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if COL-1077 (10% lidocaine vaginal bioadhesive gel)
      will be effective as an acute-use anesthetic and can decrease the pain intensity associated
      with gynecologic procedures using endometrial biopsy as a representative procedure.
    

Detailed description: 
      COL-1077 is to be self-administered by patients prior to an outpatient transvaginal
      pipelle-directed endometrial biopsy with tenaculum placement in otherwise healthy women
      requiring biopsy.
    

Intervention name(s): COL-1077; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): single dose of 150mg lidocaine (10%w/w) administered by intravaginal insertion; single dose of bioadhesive gel administered by intravaginal insertion
Other intervention name(s): lidocaine bioadhesive gel, 10%; bioadhesive gel
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Investigate the Effect of a Single Dose of AZD7624 on Inflammation Caused by an Endotoxin Challenge
Condition: LPS Challenge, Neutrophils
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the effect of a single dose of AZD7624 on inflammation caused by an
      endotoxin challenge.
    

Detailed description: 
      This is a double-blind, randomised, placebo controlled, 2-way cross-over study to investigate
      the effects of a single dose of inhaled AZD7624 on white blood cells and inflammatory markers
      in induced sputum and blood after oral inhalation of LPS as well as the safety, tolerability
      and pharmacokinetics (PK) of AZD7624 following a single inhaled dose.
    

Intervention name(s): AZD7624; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): nebuliser solution; 20 mg/mL for inhalation; nebuliser solution for inhalation
Intervention MeSH terms: AZD7624
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Healthy volunteers, Phase 1
Postpartum Uterine Regression
Condition: Uterine Leiomyoma
MeSH terms: Leiomyoma; Myofibroma
Study type: Observational

Summary: 
      Uterine leiomyomas are the leading cause of hysterectomy in the United States, accounting for
      over 200,000 procedures each year. Most epidemiologic studies of uterine leiomyoma show that
      parity has a protective association with leiomyoma, but the mechanism is not known. Both
      epidemiologic data and data from an animal model indicate that the protective association is
      not an artifact resulting from reduced fertility among women with fibroids. We hypothesize
      that the process of uterine regression following delivery results in loss of small fibroids
      due to selective apoptosis of transformed cells and the extensive remodeling of the entire
      uterus.
    

Detailed description: 
      Background: Uterine leiomyomas are the leading cause of hysterectomy in the United States,
      accounting for over 200,000 procedures each year. Most epidemiologic studies of uterine
      leiomyoma show that parity has a protective association with leiomyoma, but the mechanism is
      not known. Both epidemiologic data and data from an animal model indicate that the protective
      association is not an artifact resulting from reduced fertility among women with fibroids. We
      hypothesize that the process of uterine regression following delivery results in loss of
      small fibroids due to selective apoptosis of transformed cells and the extensive remodeling
      of the entire uterus.

      Study Objectives: Monitor fibroids during pregnancy and after postpartum uterine regression
      to assess any loss of fibroids and change in size of fibroids.

      Methods: Add a postpartum ultrasound examination to an existing epidemiologic study of
      pregnant women. The parent study documents fibroid number, size, and location with a 7 week
      ultrasound examination. With the additional postpartum ultrasound proposed here, data on
      fibroid number, size, and location through pregnancy and postpartum uterine regression will
      be collected on approximately 400 women. A subsample of 30 women will also have an MRI after
      their postpartum ultrasound in order to evaluate the sensitivity of ultrasound imaging.

      Significance: This study will provide the first data on fibroid change with
      parturition/postpartum uterine regression for a large sample of women. If small fibroids
      disappear during this time, it will document a process that results in "natural regression"
      of these tumors in premenopausal women. Insights from the biology of this process may be
      useful in developing treatment that could be used by nonpregnant women with fibroids to
      induce tumor regression.
    

Observational model: Case-Only
Time perspective: Prospective
Keywords: Apoptosis; Environment; Infection; Inflammation; Leiomyoma; Uterine Leiomyoma; Uterus
Norwegian Psychomotor Physiotherapy in Patients With Long-lasting Musculoskeletal Pain.
Condition: Physical Disability
Study type: Interventional

Summary: 
      The aim is to examine the effect of Norwegian Psychomotor Physiotherapy (NPMP) in employees
      with long-lasting musculoskeletal pain compared to employees receiving Cognitive Patient
      Education in combination with active individual physiotherapy (COPE-PT) on pain, function,
      quality of life and sick-leave
    

Detailed description: 
      The NPMP is based on the assumption that patients with long-lasting problems, physical and/or
      psychological, may react with general aberrations related to posture, respiration, and
      movements, as well as with muscular tension and skin changes.

      Employees With Long lasting musculoskeletal pain problems, working in the Municipality of
      Bergen, will be invited to participate in an Randomized Clinical Trial (RCT), and randomized
      to either receive Norwegian Psychomotor Physiotherapy (NPMP) or a series of Cognitive Patient
      Education in combination with active individual physiotherapy (COPE-PT). The aim is to
      examine the effect of NPMP compared to those receiving COPE-PT on pain, function, quality of
      life and sick-leave.
    

Intervention name(s): Norwegian Psychomotor Physiotherapy; Cognitive Patient Education and PT
Intervention type(s): Other; Other
Intervention description(s): The recruited patients will after randomization receive either Norwegian Psychomotor Physiotherapy (NPMP) or COPE combined with active individual physiotherapy. In NPMP the treatment is individualized, targeting body-mind awareness through exercise, massage and therapeutic conversation; The comparison group will receive a combination of education about how to manage pain (COPE) followed by active individual physiotherapy.
Other intervention name(s): NPMP; COPE- PT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Musculoskeletal disorders; Psychosomatic; Pain
Effects of Soft Tissue Mobilization of Neck Muscles in Individuals With Myogenous Temporomandibular Disorders: Muscle Energy Technique and Strain-counterstrain
Condition: Myogenous Temporomandibular Disorders (mTMD)
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional

Summary: 
      This is a prospective case series study.There were 20 individuals with chronic neck pain
      accompanied by myogenous temporomandibular disorders(mTMD) from Linkou and Taoyuan Chang Gung
      hospitals, and Chang-Gung university. The purpose of this study was, first, to investigate
      the effects of muscle energy technique (MET) or strain-counterstrain (SCS) applied on the
      tender or trigger points of neck muscles on improving pain and pressure pain sensitivity in
      neck and masticatory muscles, the maximal mouth-opening range of motion, chewing endurance,
      and head-neck-shoulder posture in patients with chronic neck pain accompanied by mTMD.
      Second, whether the significant effects could be reached within the four-week intervention
      duration.
    


Intervention name(s): Muscle energy technique (MET); Strain-counterstrain (SCS); sham SCS
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): A manual therapy technique that uses the gentle muscle contractions of the patient to relax and lengthen muscles and normalize joint motion.; It's also called the "positional release technique", a manual therapy technique that passively positions the hypertonic (spasmed) muscles and dysfunctional joints in positions of shortened or comfort.; SCS intervention that position with opposite site limb and direction, and with modified method as consider the easiness of a practitioner to press the tender points
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Include elements of both longitudinal (three groups) and cross-sectional (four-weeks intervention) research designs
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: myogenous temporomandibular disorders, neck pain, muscle energy technique, strain-counterstrain, head-neck posture
A Dose-Ranging Phase II Study of AUR101 in Psoriasis (INDUS-3)
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase II, Multicenter, Double-blind, Double-dummy, Placebo controlled, Randomized Study to
      Evaluate the Efficacy and Safety of AUR101 in patients with Moderate-to-Severe Psoriasis
      (INDUS-3)
    

Detailed description: 
      This will be a multicenter, double-blind, double-dummy, placebo controlled, randomized study
      to evaluate the efficacy and safety of AUR101 in patients with moderate-to-severe psoriasis.

      Approximately 128 patients with chronic moderate-to-severe plaque psoriasis (defined as
      Psoriasis Area and Severity Index (PASI) ≥12 and Body Surface Area (BSA) involved ≥10%) will
      be randomized to four groups (three dose groups of AUR101 and one placebo group) in the ratio
      of 1:1:1:1.

      The patients in each arm will receive AUR101 of 200 mg twice daily, 400 mg twice daily, 400
      mg once daily or matching placebo for 16 weeks in a double blind, double dummy fashion. All
      patients will be followed up for 14 ± 2 days of their last dose for safety assessment.
    

Intervention name(s): AUR101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral ROR-gamma inverse agonist; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There are 4 groups in the study; 1 with placebo and 3 with different AUR101 dosing regimens
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: psoriasis; AUR101; ROR; RORgamma; RORgamma inverse agonist; RORgamma inhibitor
Pilot Study of Laser Hair Depilation for Pilonidal Disease
Condition: Pilonidal Disease
Study type: Interventional

Summary: 
      Pilot study to assess tolerability and safety of laser hair depilation in adolescents and
      young adults with pilonidal disease.
    

Detailed description: 
      This is a pilot study to measure safety and tolerance of laser hair depilation in adolescents
      and young adults with pilonidal disease as a potential treatment to intervene on future
      recurrence.

      Up to a total of 10 patients will be enrolled.

      Each patient will be involved in the study for one year. Patients will be brought into
      Surgery clinic for 1 laser treatment every 4-6 weeks to obtain a total of 5 treatments.
      Follow up will occur monthly from the time of initial treatment through 1 year after the last
      treatment as we evaluate for tolerance and efficacy.

      Inclusion Criteria

        -  English and non-English speaking patients

        -  All Fitzpatrick skin types

        -  Age : 12-20 years

        -  Diagnosis of pilonidal disease

      Exclusion Criteria

        -  History of photosensitivity

        -  Actively inflamed pilonidal sinus

      Laser depilation treatment: Patients will be brought into Surgery clinic for 1 treatment
      every 4-6 weeks to obtain a total of 5 treatments. The treatment will consist of an 810 nm or
      Nd:YAG depending on Fitzpatrick skin type and tolerability. A cooling platform and
      application of topical lidocaine cream will be used to minimize any discomfort associated
      with the heat of the laser treatments.

      Initial follow up for the laser depilation group will be performed to assess for tolerance of
      the laser treatment. Patients will report their pain every 6 hours for the first 48 hours
      after their laser hair depilation treatment. Once tolerance is established, patients will
      return to surgical clinic every month for their laser or placebo visit. After the 5th clinic
      visit, they will receive a telephone call monthly to assess for any evidence of resolution or
      recurrence of disease up to 1 year after the completion of the treatments.
    

Intervention name(s): Laser depilation
Intervention type(s): Device
Intervention description(s): Laser depilation of natal cleft (pilonidal region)
Intervention model: Single Group Assignment
Intervention model description: Laser hair removal
Masking: None (Open Label)
Primary purpose: Treatment