bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Ad-RTS-hIL-12 With Veledimex in Combination With Nivolumab in Subjects With Glioblastoma; a Substudy to ATI001-102
Condition: Glioblastoma
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This research study involves an investigational product: Ad-RTS-hIL-12 given with veledimex
      for production of human IL-12. IL-12 is a protein that can improve the body's natural
      response to disease by enhancing the ability of the immune system to kill tumor cells and may
      interfere with blood flow to the tumor.

      Nivolumab is an antibody (a kind of human protein) that is being tested to see if it will
      allow the body's immune system to work against glioblastoma tumors. Opdivo (Nivolumab) is
      currently FDA approved in the United States for melanoma (a type of skin cancer), non-small
      cell lung cancer, renal cell cancer (a type of kidney cancer), Hodgkin's lymphoma but is not
      approved in glioblastoma. Nivolumab may help your immune system detect and attack cancer
      cells. Ad-RTS-hIL-12 and veledimex will be given in combination with Nivolumab to enhance the
      IL-12 mediated effect observed to date.

      The main purpose of this substudy is to evaluate the safety and tolerability of a single
      tumoral injection of Ad-RTS-hIL-12 given with oral veledimex in combination with nivolumab.
    

Detailed description: 
      Eligible patients will receive one dose of nivolumab, via infusion, one week prior to
      standard of care craniotomy and tumor resection (subtotal or total). On the day of surgery,
      patients will receive one dose of veledimex before the resection procedure. Ad-RTS-hIL-12
      will be administered by free-hand injection. Patients will continue on oral veledimex for 14
      days. Following veledimex, patients will receive nivolumab via infusion every two weeks.

      The study is divided into three periods: the screening period, the treatment period and the
      follow-up period.
    

Intervention name(s): Ad-RTS-hIL-12; veledimex; Nivolumab
Intervention type(s): Biological; Drug; Drug
Intervention description(s): 2.0 x 10^11 viral particles (vp) per injection
intratumoral injection of Ad-RTS-hIL-12; 2 doses (10mg/day, 20mg/day)
15 oral daily doses of veledimex; 2 doses (1mg/kg, 3mg/kg)
Every 2 weeks
Other intervention name(s): Opdivo
Intervention MeSH terms: Nivolumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Remote Interactive Intervention for Loneliness
Condition: Older Adults
Study type: Interventional

Summary: 
      Background:

      During the COVID-19 pandemic, governments around the world adopted the practice of physical
      distancing, which increased the loneliness experienced by seniors and indirectly affected
      their quality of life and social support. Remote interaction through online social apps may
      be the safest and easiest way to address these problems. However, the empirical research on
      this issue is very limited.

      Objective:

      This study investigated the impact of a 12-week remote interaction intervention on
      loneliness, quality of life, and social support for seniors living in a community during the
      COVID-19 pandemic.

      Methods:

      This study adopted a randomized controlled trial design and was conducted in communities in
      central Taiwan. Participants in the intervention group received a 12-week bidirectional
      remote interaction intervention, while participants in the control group received a 12-week
      unidirectional remote interaction intervention. The study's primary assessment tools were the
      UCLA Loneliness Scale and the World Health Organization Quality of Life-BREF Scale
      (WHOQOL-BREF). The secondary assessment tool was the Inventory of Socially Supportive
      Behavior.
    


Intervention name(s): Bidirectional remote interaction intervention; Unidirectional remote interaction intervention
Intervention type(s): Other; Other
Intervention description(s): Intervention group participants engaged in a 12-week bidirectional remote interaction. All interactions were conducted through the same group on Line. A one-hour interactive online group intervention was held every Monday to Friday from 14:30 to 15:30, for a total of 60 hours. The online interactive interventions were conducted in a structured course format, with a facilitator conducting live classes and alternating between static and dynamic classes.; Control group participants engaged in a 12-week unidirectional remote interaction. All interactions were conducted through the same group on Line. Research assistants posted a YouTube video on the Line group at 14:30 every day, Monday through Friday, covering art, music, senior sports, long-term care resources, travel, and food preparation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Prognostic Impact of Increased Lymph Node Yield in Colorectal Cancer Patients With Synchronous Distant Metastasis: a Population-based Study of the US Database and a Chinese Registry
Condition: Colorectal Cancer Stage IV; Lymph Node Yield
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      The National Quality Forum has endorsed at least 12 lymph node yield (LNY) as a surgical
      quality indicator in colorectal cancer (CRC), but the prognostic value of adequate
      lymphadenectomy has rarely been investigated for CRC patients with distant metastatic
      disease.
    

Detailed description: 
      Data on CRC patients with synchronous liver metastasis (LM) were derived from the US
      Surveillance, Epidemiology, and End Results (SEER) and a Chinese registry (from two Chinese
      tertiary centers: The Second Affiliated Hospital of Harbin Medical University and National
      Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical
      College) between January 2010 and December 2017. Individual level data on patients with
      incident CRC were consecutively collected in both registries. The primary tumor site was
      divided into three subsites according to International Classification of Diseases for
      Oncology (ICD-O-3) topography codes: proximal colon (C18.0, C18.1, C18.2, C18.3 and C18.4),
      distal colon (C18.5, C18.6, C18.7) and rectum (C19.9 and C20.9). The synchronous LM were
      identified by imaging or histopathological examinations. Synchronous LM refers to liver
      lesions found within 6 months after the diagnosis of primary CRC. Patients were excluded if
      they did not undergo surgery for CRC, did not have data on number of LNs retrieved and their
      survival status was unknown.
    

Intervention name(s): lymph node yield
Intervention type(s): Other
Intervention description(s): We recorded the number of lymph nodes dissected during surgery in patients with colorectal cancer
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        the US Surveillance, Epidemiology, and End Results (SEER) and a Chinese registry (from two
        Chinese tertiary centers: The Second Affiliated Hospital of Harbin Medical University and
        National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union
        Medical College) between January 2010 and December 2017
An Open Trial of Allopurinol in Patients With Poorly Responsive Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      This is a four week open label trial of ALLOPURINOL to the treatment regime of ten (10)
      poorly responsive patients with schizophrenia, monitoring their response and side-effects. No
      change in medication is required.
    


Intervention name(s): Allopurinal
Intervention type(s): Drug
Intervention description(s): 300mg once daily by mouth for four weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Conservative Pulp Therapy of Primary Molars Using TheraCAL
Condition: Reversible Pulpitis
MeSH terms: Pulpitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is a clinical trial that assesses the clinical and radiographic success rates of 3
      conservative pulp therapy treatments in primary molars compared to conventional pulpotomy
      using a bioactive dual cured calcium silicate cement (TheraCAL PT).
    

Detailed description: 
      Participating Children will be recruited from the outpatient's clinic of pediatric dentistry
      department , Faculty of Dentistry Ain Shams University and will be allocated to one of the
      following groups; Indirect pulp capping, direct pulp capping, partial pulpotomy or pulpotomy.
      TheraCAL PT, a dual cured tricalcium silicate cement will be used in all groups as the pulp
      capping material. Children will be followed every 6 months for a period of 1 year to evaluate
      clinical and radiographic success.
    

Intervention name(s): Dual cured resin modified tricalcium silicate cement
Intervention type(s): Drug
Intervention description(s): A resin based, dual cured tricalcium silicate based cement
Other intervention name(s): TheraCal PT
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: indirect pulp capping; direct pulp capping; partial pulpotomy; pulpotomy; TheraCal; primary molars
Cortical Dynamics of Inhibitory Control: A Concurrent tDCS-MEG Study
Condition: Impulsive Behavior
MeSH terms: Impulsive Behavior
Study type: Interventional

Summary: 
      This study aims to use concurrent Transcranial Direct Current Stimulation (tDCS) and
      Magnetoencephalography (MEG) with measures of impulsivity to examine the neurobiological
      underpinnings of rapid response impulsivity (RRI) and how these can be modified using tDCS in
      healthy subjects.
    

Detailed description: 
      Concurrent tDCS-MEG parallel arms single-blinded experimental design (right anodal v sham
      tDCS) will be employed in this study. The study will be conducted at the University of
      Nottingham, using a sample of student volunteers. This study aims to examine the influence of
      anodal tDCS on beta-band and alpha-band oscillatory activities, using an anti-saccade task
      administered before, during and after tDCS stimulation. It can potentially help understand
      the neurobiological mechanisms underpinning rapid response impulsivity and how these can be
      influenced by tDCS.

      The research hypotheses are that (i) a generalised mechanism for top-down inhibitory control
      will play a vital role, whereby prefrontal beta-band activity initiates alpha-band activity
      for functional inhibition over the frontal eye fields and other areas in the neurocircuitry
      involved in RRI; (ii) anodal tDCS (as opposed to sham) delivered over the right DLPFC will
      enhance this mechanism; and (iii) there will be no significant correlations between measures
      of self-report impulsivity and performance on the anti-saccade task and measures of
      oscillatory activity.
    

Intervention name(s): Anodal tDCS; Sham tDCS
Intervention type(s): Device; Device
Intervention description(s): The experimental condition will use a constant current of 2mA for 20 minutes, delivered via gradual increase and decrease over 10 seconds at the onset and offset of stimulation (current ramps), respectively.; The anodal electrode will be placed over the supreorbital ridge. The current will be delivered only in the first 10 seconds, after which the stimulation will cease but with the electrodes still in place throughout the session. The session will last for 20 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Concurrent tDCS-MEG parallel arms single-blinded experimental design (right anodal v sham tDCS).
Masking: Single (Participant)
Primary purpose: Treatment
Hormonal Contraception and Vaginal Health
Condition: Contraceptive Usage; Vaginal Epithelial Disruption
Study type: Interventional

Summary: 
      The purpose of this study is to help determine if the route by which women receive hormonal
      contraception causes different changes to occur in the lining of the vagina. The
      investigators plan to compare an oral route (taking birth control pills) with a vaginal route
      (using a vaginal ring).
    

Detailed description: 
      The investigators intend to conduct a prospective, randomized study at Oregon Health and
      Science University. This study will be conducted over six 28-day cycles. Subjects enrolled in
      the study will undergo baseline vaginal biopsy and then be randomized to receive either
      intravaginal ethinyl estradiol and etonogestrel (NuvaRing®) or oral ethinyl estradiol and
      desogestrel (Desogen®). Repeat vaginal biopsies will be obtained after three and six months
      of exposure to either oral or intravaginal hormonal contraception. These will be analyzed to
      measure the thickness of the vaginal epithelium and to quantify the presence of Langerhans
      cell, macrophages, T-lymphocytes and dendritic cells.
    

Intervention name(s): Desogen (ethinyl estradiol and desogestrel); NuvaRing (ethinyl estradiol and etonogestrel)
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol; Place the ring in the vagina for 3 weeks, remove for one week. Repeat with new Ring
Other intervention name(s): Desogen®; NuvaRing®
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Etonogestrel; Desogestrel; NuvaRing; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: contraception; NuvaRing; Desogen; vaginal biopsy
Effectiveness of Proprioceptive Training on Dynamic Postural Balance During Pregnancy
Condition: Disturbance; Balance; Pregnancy
Study type: Interventional

Summary: 
      The purpose of the present study was to measure the effect of proprioceptive training,
      short-term, on dynamic postural balance during pregnancy and after 8 weeks of follow-up.

      Thirty-nine pregnant women were randomized to either the intervention group(n=20) , which
      would perform proprioceptive exercise, or the control group(n=19, no intervention) .
    

Detailed description: 
      Improvement in the postural balance of pregnant women may be the improvement in joint
      mechanoreceptor activation present in the joint capsules, medial ligament, posterior cruciate
      ligament, and meniscus, which result in improved articular stabilization and, consequently, a
      possible increase in the musculature's ability to provide co-contraction.

      Improved their postural control after the intervention may have been due to central and
      peripheral nervous system balance control circuits and strength gains, which showed
      improvements extending from the second to the third trimester . The maintenance of postural
      balance requires the integration of the visual, vestibular, and somatosensory systems.

      At the spinal level, first level of motor control, nervous reflex movement patterns are
      received from higher levels of the nervous system. This provides for reflex splinting during
      conditions of abnormal stress about the joint and has significant implications for
      rehabilitation.The muscle spindles play a major role in the control of muscular movement by
      adjusting activity in the lower motor neurons.

      The second level of motor control is the brain stem, where the joint afferent is relayed to
      maintain the posture and balance of the body. Information delivered to the brain stem
      emanates from the joint proprioceptors, the vestibular centers in the ears, and the eyes.The
      final aspect of motor control includes the highest level of CNS function (motor cortex, basal
      ganglia, and cerebellum)and is mediated by cognitive awareness of body position and movement.
      Movements that are repeated can be stored as central commands, and can be performed without
      continuous reference to consciousness. This better joint afferent between the peripheral and
      central nervous system control may be reflected in the improvement of balance during
      pregnancy, as observed in this study as a result of proprioceptive training delivered to
      pregnant women.
    

Intervention name(s): Proprioceptive exercises; Control
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Efficacy of Escitalopram in the Treatment of Internet Addiction
Condition: Internet Addiction
MeSH terms: Behavior, Addictive; Internet Addiction Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to determine whether Lexapro (Escitalopram) is safe and
      effective in treating problematic internet use.
    

Detailed description: 
      Many individuals experience marked distress and functional impairments as a result of their
      perceived inability to control their 'non-essential' (non-job/school related) use of the
      Internet. Frequently these people develop a preoccupation with the Internet, a need for
      escape to the Internet, and increasing irritability when trying to cut back use of the
      Internet. There have been no studies to date looking at the effectiveness of medications in
      the treatment of this disorder. In our clinical experience, we find these patients with
      Internet addiction usually respond to serotonin reuptake inhibitors within 12 weeks. This
      study will examine the efficacy of escitalopram in Internet addiction among adults.
    

Intervention name(s): Escitalopram
Intervention type(s): Drug
Intervention description(s): 10 mg/day
Other intervention name(s): Lexapro
Intervention MeSH terms: Escitalopram
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Internet addiction; Problematic internet use; Escitalopram; Lexapro
Effect of Ambient Noise on the Responses to Meal Ingestion
Condition: Healthy
Study type: Interventional

Summary: 
      Meal ingestion induces sensations that are influenced by a series of conditioning factors.
      Aim: to determine the effect of ambient noise on the sensory responses to a standard probe
      meal. Randomized, cross-over study in healthy subjects comparing the effect of ambient noise
      versus silence on the sensations induced by a probe meal. Participants (12 men) will be
      instructed to eat a standard dinner the day before, to consume a standard breakfast at home
      after overnight fast, and to report to the laboratory, where the test meal will be
      administered 5 h after breakfast. Studies will be conducted in a quiet, isolated room with
      participants sitting on a chair. One study day, a noise will applied via headphones for 60
      min after meal ingestion and the other day headphones without sound will applied. Perception
      of homeostatic sensations (hunger/ satiation, fullness) and hedonic sensations (digestive
      well-being, mood) will be measured at 5 min intervals 10 min before and 20 min after
      ingestion and at 10 min intervals up to 60 min after the probe meal.
    


Intervention name(s): Noise; Silence
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Noise applied via headphones during 60 min after meal ingestion; Headphones without sound applied during 60 min after meal ingestion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: meal ingestion; postprandial responses; hedonic sensations; homeostatic sensations; ambient noise
An Adaptive Treatment Strategy for Adolescent Depression-Continuation
Condition: Adolescent Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Aim 1: Assess the feasibility and acceptability of the personalized continuation treatment
      strategy.

      Aim 2: Estimate variances of primary and secondary outcomes with the continuation treatment.

      Aim 3: Conduct exploratory hypothesis-generating analyses to inform further development of
      the personalized continuation treatment strategy to be tested in a subsequent R01 proposal.
    

Detailed description: 
      Male and female adolescents (ages 12-18) will be eligible for the study if they completed
      acute phase treatment and showed at least a partial response to treatment (CGI-I of minimally
      improved or better (CGI-I < 3)). Adolescents will enter continuation treatment having either
      received 12 sessions of IPT-A, 16 sessions of IPT-A, or 12 sessions of IPT-A plus
      fluoxetine.This is a continuation of the study "An Adaptive Treatment Strategy for Adolescent
      Depression (PTAD)" NCT01802437
    

Intervention name(s): Fluoxetine; Interpersonal Psychotherapy
Intervention type(s): Drug; Behavioral
Intervention description(s): Prozac (fluoxetine capsules, USP) is a selective serotonin reuptake inhibitor for oral administration.; Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.
Other intervention name(s): Prozac; IPT
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Bioequivalence Study of Torrent Pharmaceuticals Ltd.'s Olmesartan Medoxomil Tablet Under Fasting Conditions
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Subjects to compare the single dose bioavailability of Torrent's Olmesartan Medoxomil Tablets
      40 mg and Benicar 40 mg Tablets of Daichi Sankyo Inc. USA. Dosing periods of studies were
      separated by a washout period of 7 days.
    

Detailed description: 
      An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose
      Bioequivalence Study of Olmesartan Medoxomil Tablets containing Olmesartan Medoxomil 40 mg
      (Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Benicar® 40 mg Tablets
      containing Olmesartan Medoxomil 40 mg (Reference, Daiichi Sankyo Inc.,USA) in Healthy Human
      Volunteers Under Fasting Condition.
    

Intervention name(s): Torrent's Olmesartan Medoxomil Tablets 40 mg; Daiichi Sankyo Inc's Benicar Tablets 40 mg
Intervention type(s): Drug; Drug
Intervention MeSH terms: Olmesartan; Olmesartan Medoxomil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment