bioihbjkbjnl/mcl2 huggingface dataset:
TS Gene Polymorphism Predicts Effect in Patients With Advanced Lung Cancer
Condition: Non-small-cell Lung Cancer; Adenocarcinoma
MeSH terms: Lung Neoplasms; Adenocarcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators performed a multicenter, open trial of using TS gene polymorphism to
      predict advanced lung adenocarcinoma effect to pemetrexed combined with cisplatin regiment as
      first-line treatment.
    

Detailed description: 
      1. Main eligibility criteria were histologic or cytologic proof of advanced non-small-cell
           lung cancer (NSCLC) primary treatment, normal organ function, and Eastern Cooperative
           Oncology Group performance status 0 to 2.

        2. All Patients were delivered to pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 for not less
           than 4 cycle, administered intravenously every 3 weeks. Response assessment was
           performed every 6 weeks; toxicity assessment was performed every 3 weeks.

        3. Primary end point was time to progression (TTP); secondary end points were objective
           response rate (ORR), overall survival (OS), and toxicity.

        4. The study was designed to evaluate TS(thymidylate synthase) gene polymorphism as a
           predictor for advanced lung adenocarcinoma effect to pemetrexed combined with cisplatin
           regiment as first-line treatment.

        5. Polymorphisms of thymidylate synthase were investigated in peripheral WBC（white blood
           cell）of all patients.
    

Intervention name(s): pemetrexed
Intervention type(s): Drug
Intervention description(s): 'TS high expression genotype': pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 on day 1 of each 21 day,for not less than 4 cycle, administered intravenously every 3 weeks.
'TS low expression genotype': pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 on day 1 of each 21 day,for not less than 4 cycle, administered intravenously every 3 weeks.
Other intervention name(s): Alimta
Intervention MeSH terms: Pemetrexed
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TS; polymorphism; lung cancer; adenocarcinoma; pemetrexed
Reducing HIV Risk Among Adolescents: Evaluating Project HEART
Condition: HIV; Sexually Transmitted Diseases
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional

Summary: 
      This study evaluates an educational web-based intervention designed to increase adolescent
      girls' motivation and skills to engage in safer sexual behavior (Project HEART: Health
      Education and Relationship Training). Half of participants will receive Project HEART and
      half of participants will receive Project Growing Minds, an attention-matched control website
      focused on growth mindsets of intelligence and self-regulation. The ultimate goal of this
      work is to help girls reduce their risk of HIV and other sexually transmitted diseases and to
      avoid unplanned pregnancies.
    

Detailed description: 
      This study evaluates an educational web-based intervention designed to increase adolescent
      girls' motivation and skills to engage in safer sexual behavior (Project HEART: Health
      Education and Relationship Training). Half of participants will receive Project HEART and
      half of participants will receive Project Growing Minds, an attention-matched control website
      focused on growth mindsets of intelligence and self-regulation. The ultimate goal of this
      work is to help girls reduce their risk of HIV and other sexually transmitted diseases and to
      avoid unplanned pregnancies.

      Primary outcomes for this study include 1) acceptability of the program, 2) communication
      self-efficacy, and 3) communication intentions.
    

Intervention name(s): Safer Sex; Growth Mindsets
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills.; Interactive web-based intervention with five modules: mindsets introduction, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and integrative summary.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Condoms; Sexual Abstinence; Sexual Communication
Sacral Neuromodulation in Patients With IC
Condition: Interstitial Cystitis
MeSH terms: Cystitis; Cystitis, Interstitial
Study type: Interventional

Summary: 
      The hypothesis for this study is that bilateral sacral neuromodulation will improve symptoms
      of interstitial cystitis by at least 25% when compared to unilateral sacral neuromodulation
      as reported by patient's responses to the Interstitial Cystitis Symptom and Problem Indices.

      This study will be a prospective randomized study comparing bilateral to unilateral sacral
      neuromodulation. The study population will include all patients diagnosed with interstitial
      cystitis, using the NIDDK criteria, having staged sacral neuromodulator stimulators placed at
      Hahnemann University Hospital.
    


Intervention name(s): Interstim
Intervention type(s): Device
Intervention description(s): Unilateral vs. Bilateral Placement of Interstim IPG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Interstitial Cystitis; IC; Neuromodulation; Interstim Therapy
Predictor of Advanced Subclinical Atherosclerosis
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Observational

Summary: 
      Evaluation of skin cholesterol for cardiovascular risk assessment in asymptomatic individuals
      at low, intermediate, or high risk based on Framingham Global Risk estimates. Carotid
      intima-media thickness (IMT), a surrogate marker for atherosclerotic burden, that
      independently predicts the occurrence of heart attack and stroke, will be the "gold standard"
      comparator.

      Hypothesis: Skin cholesterol, as measured by two non-invasive tests, correlates with CAD, as
      measured by CIMT in this population.
    

Detailed description: 
      This study will enroll 600 asymptomatic subjects at low (<6%), intermediate (6-20% ), or high
      (>20%) 10-year Framingham global cardiovascular risk in approximately equal proportions.

      Subjects will be enrolled from each of the three risk levels at each study site (6 total in
      the US). Subjects will be enrolled in a consecutive manner until there are 200 subjects from
      each risk level. We will track the number of subjects from each risk stratum. We will also
      ensure adequate representation of women (at least 33%) and African Americans (at least 25%)in
      the study.

      We will test the subjects with 2 non-invasive skin cholesterol tests and will take a sample
      of blood that will be tested for serum cholesterol values and other markers of CAD. Subjects
      will also undego a carotid IMT scan.

      The primary objective of the study is to see if skin cholesterol correlates with CAD, as
      measured by CIMT.
    

Observational model: Defined Population
Time perspective: Other
Effects of Upper Extremity Immobilization and Use of a Steering Wheel Spinner Knob Following Distal Radius Fracture
Condition: Distal Radius Fracture
MeSH terms: Fractures, Bone; Radius Fractures; Wrist Fractures
Study type: Interventional

Summary: 
      The aims of the study are to better understand how upper extremity injury and immobilization
      influences a patient's steering ability. Patients with acute distal radius fractures treated
      with surgery will be recruited for study in a driving simulator. The results will hopefully
      assist physicians to better counsel patients with upper extremity injuries on when it is safe
      to return to driving.
    

Detailed description: 
      The ability of an injured person to safely drive an automobile while immobilized in an upper
      extremity cast or splint is not well defined.

      The aims of the study are to better understand how upper extremity injury and immobilization
      influences a patient's steering ability. The secondary aim is to further evaluate the
      effectiveness of a steering wheel spinner-knob to assist with one-handed driving. A steering
      wheel spinner knob may be a surrogate to assist with one handed driving while immobilized.
    

Intervention name(s): Spinner knob; No Knob
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: distal radius fracture; steering; steering wheel spinner knob
Risks of COVID19 in the Pregnant Population
Condition: COVID19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      It is unclear how COVID19 can be passed from mother to infant. The study investigators aim to
      collect maternal and neonatal samples from COVID19-infected pregnant women and compare them
      to pregnant women who have clinical indications for COVID 19 testing at the time of hospital
      admission but end up being COVID19 negative. Pregnant women who are either COVID19 positive
      or COVID19 negative with respiratory symptoms will be enrolled and followed during this
      study.
    

Detailed description: 
      The objectives are to understand the prevalence of maternal fetal transmission, risk factors
      and outcomes of a COVID19 positive pregnancy, and how the virus can be passed from mother to
      infant in the pregnant population at Mayo Clinic Rochester MN. Assessments will include the
      viral detection and viral load in maternal and fetal specimens collected from COVID19
      positive mother-baby dyads, presence of maternal and fetal inflammatory markers in blood and
      tissues, anti-COVID IgG and IgM in maternal and neonatal blood, viral load and viral antigens
      in maternal and fetal specimens. placental gross and histopathologic changes in COVID19
      infected mothers, stratified by gestational age and disease severity, compared to control
      samples.

      .
    

Intervention name(s): Biospecimen collection
Intervention type(s): Other
Intervention description(s): Maternal blood, vaginal swab, and anorectal swab will be obtained at the time of enrollment prior to delivery. A sample of breastmilk before hospital discharge and again at six weeks postpartum will be obtained if the mother is lactating.
Neonatal specimens collected following delivery will include placental tissue, fetal membrane roll, umbilical cord tissue, umbilical cord blood, and an anorectal swab.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women testing positive for COVID19 at any time during their pregnancy after 8
        weeks gestation, with or without physical symptoms. Pregnant women with respiratory or
        other physical symptoms of COVID19 and uncertain or negative COVID19 test results at the
        onset of labor.

        Infants of these women will be followed for outcomes.
      
Biospecimen description: 
      Maternal specimens obtained at time of enrollment prior to delivery: blood, vaginal swab,
      anorectal swab. Breastmilk obtained before hospital discharge and again at six weeks
      postpartum if the mother is lactating.

      Neonatal specimens: placental tissue, fetal membrane roll, umbilical cord tissue, umbilical
      cord blood, and an anorectal swab.
    
Keywords: COVID19; Coronavirus; Pregnancy; Viral infection
Depression Online Assessment and Therapy
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      One Aim of the current study is to better understand why some patients suffering from
      depression do not seek professional help by doctors but in the internet.

      Furthermore patients with depression will receive Online Therapy for depression. Aim of this
      part of the study is to investigate whether quality of life changes accordingly to
      improvement of symptoms after online therapy.
    

Detailed description: 
      -  German speaking patients can register online. There will be no side visits.

        -  After screening: patients which meet inclusion criteria and no exclusion criteria can
           take part in online therapy for depression.

        -  After 12 weeks 2nd online survey. After this survey patients can use the program the
           following 6 months (follow-up)

        -  After 6 months 3rd and last online-survey.

        -  According to the aims of the study cross-sectional as well as longitudinal data will be
           obtained and analysed
    

Intervention name(s): Mail support; no mail support
Intervention type(s): Other; Other
Intervention description(s): between post treatment and follow up two groups: one with unspecific mail support every 2 weeks one without; follow-up without mail support
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: depression; online therapy; cognitive behavioural therapy; quality of life; alexithymia; therapy expectation and satisfaction
A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy and Safety of NNC0114-0006 in Subjects With Active Crohn's Disease
Condition: Inflammation; Crohn's Disease
MeSH terms: Crohn Disease; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is conducted in Europe and the United States of America (USA). The aim of the
      trial is to assess clinical efficacy and safety of NNC0114-0006 in subjects with active
      Crohn's disease.
    


Intervention name(s): NNC0114-0006; placebo
Intervention type(s): Drug; Drug
Intervention description(s): A single i.v. (intravenous, into the vein) dose. At week 12 the possibility to administer an additional open-label dose of NNC0114-0006 will be provided to all subjects irrespective of initial treatment allocation as long as they are not in need of rescue medication, as judged by the clinical investigator.; A single i.v. (intravenous, into the vein) dose. At week 12 the possibility to administer an additional open-label dose of NNC0114-0006 will be provided to all subjects irrespective of initial treatment allocation as long as they are not in need of rescue medication, as judged by the clinical investigator.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Role of COX-2 Inhibition in Salt Sensitivity of Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if the drug Celebrex changes the way the kidney
      gets rid of salt and maintains blood pressure.
    

Detailed description: 
      There have been many studies done with analgesics such as acetaminophen and non-steroidal
      anti-inflammatory drugs; however it is not understood how blood pressure changes while using
      Celebrex. The study hypothesis is that Celebrex will increase salt sensitivity of blood
      pressure.
    

Intervention name(s): celecoxib (Celebrex); Placebo
Intervention type(s): Drug; Other
Intervention description(s): Celecoxib (Celebrex) was administered at 100 mg, twice per day for each day of sodium diet; Placebo pill taken twice per day on each day of the diet
Other intervention name(s): Celebrex
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Salt sensitivity of Blood Pressure
Study Evaluating the Safety and Tolerability of SCA-136 in Healthy Japanese and Non-Japanese Female Subjects
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to evaluate the safety and tolerability of ascending multiple
      oral doses of SCA-136 adminstered to healthy Japanese and non-Japanese female subjects.
    


Intervention name(s): SCA-136
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Pharmacokinetics; Pharmacodynamics
Evaluation of Oral PCA Device - PCoA™ Acute
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Randomized, open label, controlled pilot clinical study comprised hospitalized post operative
      patients receiving oral analgesics. The study aims to evaluate the safety, efficacy and
      usability of a novel pill dispensing system - PCoA™ Acute and compare it to the conventional
      procedure of nurse providing analgesics.
    


Intervention name(s): patients receiving oral analgesics via the PCoA™ Acute
Intervention type(s): Device
Intervention description(s): PCoA™ Acute is an oral PCA device, designed to provide safe and easy-to-use pain medication at the bedside. It identifies patients by Radio Frequency Identification (RFID) technology and provides pill dispensing upon patient's request.
Intervention MeSH terms: Analgesics
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Study includes 2 groups: test group comprised patients receiving oral analgesics via the PCoA™ Acute and control group of nurse providing analgesics.
Masking: None (Open Label)
Primary purpose: Treatment
Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer
Condition: Kidney Cancer
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: This phase II trial is studying how well atrasentan works in treating patients with
      locally recurrent or metastatic kidney cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the 6-month progression-free survival rate, in terms of proportion of those
           with measurable disease or bone metastases only, of patients with locally recurrent or
           metastatic renal cell carcinoma treated with atrasentan (measurable disease stratum
           closed to accrual as of 7/16/04).

        -  Determine the toxicity of this drug in these patients.

      OUTLINE: This is a multicenter study. Patients are stratified according to prior
      immunotherapy/biologic therapy (yes vs no) and characteristic of disease (measurable vs bone
      metastases only) (measurable disease stratum closed to accrual as of 7/16/04).

      Patients receive oral atrasentan once daily on days 1-28. Courses repeat every 28 days in the
      absence of disease progression or unacceptable toxicity.

      Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
      annually for 5 years.

      PROJECTED ACCRUAL: A total of 180 patients (90 per stratum [with or without prior therapy])
      will be accrued for this study within 6 months (based on prior accrual, the bone metastases
      only group [specifically patients who have received 1 prior therapy] is the only stratum open
      for accrual).
    

Intervention name(s): atrasentan hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Atrasentan
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV renal cell cancer; recurrent renal cell cancer
Retrospective Trial on Low Prognosis Infertile Patients
Condition: Infertility, Female; Fertility Disorders
MeSH terms: Infertility; Infertility, Female
Study type: Observational

Summary: 
      The main objective of this study is to analyze management of Controlled Ovarian Stimulation
      (COS) protocols in low prognosis patients, secondly to observe the clinical outcomes
      (Fertilization Rate, Pregnancy Rate, the Ongoing Pregnancy Rate and the Live birth Rate) and
      the total units of gonadotrophins consume per M2 oocyte retrieved in this subgroup.
    

Detailed description: 
      Humanitas Fertility Center maintains an external audit anonymized electronic research queries
      system, exported from a certified only access web database, which at time of this analysis
      (cycles at December 31th 2016) include 26,883 consecutive fresh non-donors IVF cycles.
      Patients who underwent these cycles had consented in writing that their medical records could
      be used for research purposes, as long as the patients' anonymity was protected and
      confidentiality of the medical record was assured. Since both of these conditions were met,
      this study has been approved on March 2th 2017 with an expedited review and approval protocol
      by the center's Institutional Review Board (IRB).

      At least 2,000 expected low prognosis patients in the Humanitas Fertility Center Database out
      of 12,545 cycles performed in the period 2010-2015 with completed pregnancy follow-up.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        26,883 consecutive fresh non-donors IVF cycles. Patients who underwent these cycles had
        consented in writing that their medical records could be used for research purposes, as
        long as the patients' anonymity was protected and confidentiality of the medical record was
        assured. Since both of these conditions were met, this study has been approved on March 2th
        2017 with an expedited review and approval protocol by the center's Institutional Review
        Board (IRB).

        At least 2,000 expected low prognosis patients in the Humanitas Fertility Center Database
        out of 12,545 cycles performed in the period 2010-2015 with completed pregnancy follow-up.
      
Keywords: low responders
An Early Intervention to Increase Maternal Self-efficacy After Preterm Birth
Condition: Posttraumatic Stress Disorder; Stress; Anxiety; Depression
MeSH terms: Premature Birth; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      This study aims to investigate the effects of an early intervention (joint observation and
      video feedback) on maternal parenting self-efficacy following a premature birth. Mothers who
      have given birth to a very premature baby will be randomly allocated to either the early
      intervention or usual care whilst the infant is still hospitalized. Participants will be
      followed up at one month and six months. It is predicted that participants who received the
      early intervention will report higher maternal parenting self-efficacy than those who are
      not.
    


Intervention name(s): joint observation and video feedback
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: maternal parenting self-efficacy; parental stress; maternal sensitivity; mother-infant bond