bioihbjkbjnl/mcl2 huggingface dataset:
Outcomes of Resection at Different Times Between the End of Neoadjuvant Treatment and Surgery
Condition: Neoadjuvant Chemoradiotherapy; Rectal Tumor; Surgery; Surgery--Complications
MeSH terms: Rectal Neoplasms
Study type: Observational

Summary: 
      Neoadjuvant radio-chemotherapy (NRCT) represents a milestone in the treatment of selected
      rectal tumours. Ideal time interval between the end of NRCT and surgery is still debated; a
      6-8 weeks time interval is considered optimal, but shorter or longer intervals have been
      associated with better oncological outcomes. Moreover, there is a lack of data about clinical
      postoperative outcomes and different time intervals after the end of NRCT. Here, effect that
      different time intervals have on postoperative complications with particular regard to the
      anastomotic dehiscence have been evaluated.

      Methods One hundred-sixty-seven patients underwent surgery after long-course NRCT. Three
      different time intervals were considered: (0-42; 43-56; >57 days).
    

Detailed description: 
      Neoadjuvant radio-chemotherapy (NRCT) represents a milestone in the treatment of selected
      rectal adenocarcinoma. Even though a 6-8 weeks' time interval after the end of NRCT and
      surgery is considered ideal, the optimal time for surgery is still controversial.
    

Intervention name(s): Rectal Resection
Intervention type(s): Procedure
Intervention description(s): Low Anterior Resection and Abdominoperineal Resection
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        One hundred and sixty-seven patients with rectal adenocarcinoma who underwent to resection
        after combined NRCT at University Campus Bio-Medico di Roma from January 2005 to March 2015
        were retrospectively analysed.
Equivalence of A Stable Liquid Glucagon Formulation With Freshly Reconstituted Lyophilized Glucagon
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will test the hypothesis that micro-doses of Xerisol Glucagon (Xeris
      Pharmaceuticals) will be non-inferior by pharmacokinetic and pharmacodynamic criteria vs.
      micro-doses of Glucagon for Injection (Eli Lilly).
    

Detailed description: 
      This study will test the hypothesis that micro-doses of a new formulation of stable glucagon,
      Xerisol Glucagon (Xeris Pharmaceuticals), will be non-inferior by pharmacokinetic and
      pharmacodynamic criteria vs. micro-doses of a freshly reconstituted formulation of glucagon
      that has poor stability in solution, Glucagon for Injection (Eli Lilly).
    

Intervention name(s): Xeris glucagon; Lilly glucagon
Intervention type(s): Drug; Drug
Intervention description(s): The subject is given an injection of xeris glucagon; The subject is given an injection of lilly glucagon
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bionic pancreas; artificial pancreas; insulin; glucagon; clamp
Extinction Generalization in Exposure Therapy
Condition: Specific Phobia
MeSH terms: Phobic Disorders
Study type: Interventional

Summary: 
      Patients with anxiety disorders oftentimes express fear responses to more than only one
      fear-inducing object. The principal aim of this study is to examine whether the beneficial
      effects of exposure on fear reduction in spider phobia can extend to stimuli which are
      conceptually similar to spiders (i.e. cockroaches), but have never been presented during the
      respective treatment.
    

Detailed description: 
      Fear extinction has evolved as the central mechanism underlying exposure-based treatments.
      Findings from conditioning studies indicate that fear reduction following a fear extinction
      procedure can generalize from the extinction stimulus to other conceptually and perceptually
      related stimuli. This study is aimed at translating these findings to a clinical application
      and will hence examine whether the basic principles of extinction generalization are
      applicable to exposure.

      Patients with spider phobia will either receive two sessions of in-vivo exposure with spiders
      or no treatment. Prior to as well as after treatment, patient's fear of spiders will be
      assessed using the Behavioral Approach Test (BATs) and self-report questionnaires. In
      addition, BATs with cockroaches will be conducted to examine the effects of exposure therapy
      on extinction generalization.
    

Intervention name(s): Exposure treatment for spider fear
Intervention type(s): Behavioral
Intervention description(s): Two sessions (each session = 60 minutes) of in-vivo exposure treatment (including psychoeducation) with two different spiders. Exposures comprise a hierarchy of 7 steps, to be completed with both spiders.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exposure; spider phobia; generalization; extinction
The Efficacy of VR and AR on Pruritus
Condition: Chronic Renal Insufficiency; Pruritus; Itch
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic; Pruritus
Study type: Interventional

Summary: 
      The research will be conducted randomly in order to determine the effect of VR and AR on
      pruritus symptom.
    

Detailed description: 
      In this study, there will be three groups: intervention group 1 with autogenic relaxation
      (AR), intervention group 2 with virtual reality (VR) game application and control group with
      routine nursing care and kidney functions narration. The number of volunteers to be included
      in the study was determined by power analysis. Forty patients with itch symptoms will be
      included in each group. Preliminary application for all three groups will be performed in the
      patient group registered to the Dialysis Unit of the Nephrology Department of Hacettepe
      University and Baskent University Hospital. Socio-Demographic Form, 5-D Itch Scale,
      Dermatology Life Quality Index, State and Trait Anxiety Scale, Pruritus Behavior and SGO / OR
      Application Log.
    

Intervention name(s): Autogenic Relaxation; virtual reality game application; kidney function narration
Intervention type(s): Other; Other; Other
Intervention description(s): Autogenic relaxation; virtual reality game application,; kidney function narration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: itch; pruritus; nursing; virtual reality
TWICE (Ezetimibe Together With Any Statin Cholesterol Enhancement)(0653-060)
Condition: Hypercholesterolaemia; Hyperlipidaemia
MeSH terms: Hypercholesterolemia; Hyperlipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      In patients with primary hypercholesterolemia treated with a statin and with ldl-c above the
      recommended target goal (esc 2003 recommendations ldl>=1.15 g/l) to compare the efficacy and
      the safety of ezetrol added to ongoing statin and non drug therapeutic intervention (patient
      motivation on diet or physical activities or both).
    


Intervention name(s): MK-0653, ezetimibe; Duration of Treatment: 3 months
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Long-term Metazym Treatment of Patients With Late Infantile Metachromatic Leukodystrophy (MLD)
Condition: Late Infantile Metachromatic Leukodystrophy
MeSH terms: Leukodystrophy, Metachromatic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a single center, open-label study of patients with late infantile MLD. All patients
      were previous treated 26 weeks in the phase I trial (EudraCT number: 2006-005341-11,
      NCT00418561). All patients will be offered continuing treatment in this study and will in
      this protocol receive 13 infusions, whereby the patients total have had 27 infusions of
      Metazym. One infusion will be given every other week. After a total of 52 weeks of treatment
      the subjects will continue treatment in a compassionate use protocol. Safety (AE/SAE) will be
      monitored at every visit.
    


Intervention name(s): Recombinant human Arylsulfatase A (rhASA)
Intervention type(s): Biological
Intervention description(s): intravenous infusion, every other week for 26 weeks
Other intervention name(s): Metazym; HGT-1111
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metazym; Late infantile; Metachromatic leukodystrophy; Long-term safety
Evaluation of Variable Pressure Support Ventilation in the Therapy of Acute Lung Injury
Condition: Acute Lung Injury
MeSH terms: Lung Injury; Acute Lung Injury; Wounds and Injuries
Study type: Interventional

Summary: 
      Variable pressure support during assisted spontaneous breathing (noisy PSV) has been shown to
      improve the respiratory function in experimental acute lung injury (ALI). We aimed at
      comparing the effects of noisy PSV with traditional PSV on the respiratory function of
      patients suffering from ALI.
    


Intervention name(s): Assisted mechanical ventilation
Intervention type(s): Other
Intervention description(s): Patients will be mechanically ventilated with noisy PSV and PSV in random sequence
Primary purpose: Treatment
CBT Versus Selective Serotonin Reuptake Inhibitor For Treatment Of Depression In Temporal Lobe Epilepsy Patients
Condition: Depression; Epilepsy, Temporal Lobe
MeSH terms: Epilepsy; Epilepsy, Temporal Lobe; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The aim of the study is to compare the effect of group-cognitive-behavioral therapy
      (CBT)versus treatment as usual with the selective serotonin reuptake inhibitor sertraline, in
      patients with diagnosis of temporal lobe epilepsy (TLE) and depressive disorder.
    

Detailed description: 
      patients with temporal lobe epilepsy and depression will be enrolled into one of two
      treatment modality. The first group will receive 12 group cognitive behavioral sessions. CBT
      is a psychotherapy focused on the recognition and change of distorted thoughts and
      maladaptive behaviors.

      The second group will receive treatment with the selective serotonin reuptake inhibitor
      sertraline or citalopram for 12 weeks. This antidepressant is wide used to treat depression
      in patients with TLE.
    

Intervention name(s): Cognitive behavioral therapy; SSRI
Intervention type(s): Other; Drug
Intervention description(s): The CBT group will receive 12 weekly 90-minute sessions. Each session will be given in group form by one certified CBT therapist and one neuropsychiatrist in training on group therapy.
The CBT structure include psychoeducation, addressing dysfunctional thoughts and maladaptive behaviors; problem solving techniques, assertiveness, coping strategies and depression relapse prevention; Patients will receive the "treatment as usual" with a SSRI: sertraline or citalopram. In patients already taking antidepressants for more than 8 weeks before enrollment but still experiencing depressive symptoms, treatment could be optimized either by augmenting the dose of his antidepressant or by changing to one of the SSRI mentioned.
Other intervention name(s): CBT; selective serotonin reuptake inhibitor; antidepressant
Intervention MeSH terms: Antidepressive Agents; Serotonin; Selective Serotonin Reuptake Inhibitors
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive Behavioral Therapy; Selective serotonin reuptake inhibitor; depression; epilepsy
Group Empowerment of Battered Women as a Tool for Violence Prevention
Condition: Domestic Violence
Study type: Interventional

Summary: 
      Intimate partner violence against women is a significant global health problem. This study
      was designed to test the hypothesis that a group intervention based on empowerment theory of
      Paolo Freire would be effective as a means to reduce the extent and prevent violence among
      women whose partners were violent toward them.
    

Detailed description: 
      A randomized controlled trial (N=141) with two control groups (one individual
      psychotherapeutic treatment and the other a usual care group treatment) was conducted in a
      violence treatment center in the South of Israel The treatment protocol designed to empower
      battered women (EBW) was conducted with 12 groups over a period of two years. Assessments
      were made before, immediately following and at an 8 month follow up following the
      intervention.
    

Intervention name(s): EBW group intervention to empower battered women
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: women experiencing domestic violence
JUNIPER: A Phase 2 Study to Evaluate the Safety, Biological Activity, and PK of ND-L02-s0201 in Subjects With IPF
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      A phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the
      safety, tolerability, biological activity, and pharmacokinetics (PK) of ND-L02-s0201 for
      Injection in subjects with IPF.
    

Detailed description: 
      All subjects were treated with ND-L02-s0201 or placebo for 24 weeks (a total of 12 doses).
      Subject's participation in the study was approximately 40 weeks including a Screening and
      Baseline period of up to 6 weeks, a treatment period of 24 weeks (including the 2 weeks after
      the last study treatment), and a follow-up period of 10 weeks after End-of-Treatment (EOT).
    

Intervention name(s): ND-L02-s0201 (Low Dose); ND-L02-s0201 (High Dose); Other: Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Intravenous administration every 2 weeks; Intravenous administration every 2 weeks; Saline
Other intervention name(s): 45mg; 90mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of Oral Tofacitinib in the Treatment of Alopecia Areata
Condition: Extensive Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This clinical trial was conducted at the Dermatology department of Services hospital Lahore.
      Patients of extensive and treatment resistant Alopecia areata were enrolled after ethical
      approval and informed consent by non-probability consecutive sampling. Inclusion criteria:
      Treatment with oral tofacitinib citrate was initiated at 5 mg twice daily for six months.
      Scalp hair loss was calculated at 4, 12 and 24 weeks using the validated Severity of Alopecia
      Tool (SALT) score, which ranges from 0% to 100%. Regrowth rate: (initial SALT score - final
      SALT score)/(initial SALT score) × 100 was noted. Response time (time from initiation of
      treatment to any sign of hair regrowth) was noted. DLQI of patients before and after
      treatment were noted. Side effects were noted. Pre- and post-treatment photographs were
      taken. Patients were followed up for another 6 months to look for relapse.

      Data were entered and analyzed using SPSS 20. Means were calculated for quantitative
      variables, frequencies for qualitative data. Data were stratified for the role of effect
      modifiers.
    

Detailed description: 
      This clinical trial was conducted at the Dermatology department of Services hospital Lahore.
      Patients of extensive and treatment resistant Alopecia areata were enrolled after ethical
      approval and informed consent by non-probability consecutive sampling. Treatment with oral
      tofacitinib citrate was initiated at 5 mg twice daily for six months after labs and ruling
      out contraindications. Scalp hair loss was calculated at 4, 12 and 24 weeks using the
      validated Severity of Alopecia Tool (SALT) score, which ranges from 0% to 100%. Regrowth
      rate: (initial SALT score - final SALT score)/(initial SALT score) × 100 was noted. Response
      time (time from initiation of treatment to any sign of hair regrowth) was noted. DLQI of
      patients before and after treatment were noted. Side effects were noted. Pre- and
      post-treatment photographs were taken. Patients were followed up for another 6 months to look
      for relapse.

      Data were entered and analyzed using SPSS 20. Means were calculated for quantitative
      variables, frequencies for qualitative data. Data were stratified for the role of effect
      modifiers.
    

Intervention name(s): Oral Tofacitinib citrate
Intervention type(s): Drug
Intervention description(s): oral tofacitinib citrate was initiated at 5 mg twice daily after ruling out contraindications
Intervention MeSH terms: Tofacitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: alopecia areata; Tofacitinib; Efficacy; Safety; Hair loss
A New Marker for Early Diagnosis of Pneumoperitoneum-Related Acute Kidney Injury: Insulin-Like Growth Factor-1 (IGF-1)
Condition: Acute Kidney Injury (Nontraumatic); Pneumoperitoneum
MeSH terms: Pneumoperitoneum; Acute Kidney Injury; Wounds and Injuries
Study type: Interventional

Summary: 
      In our study, to show the effect of pneumoperitoneum on acute kidney injury in patients
      scheduled for laparoscopic surgery, NGAL and IGF-1 values will be measured before, after and
      24 hours after pneumoperitoneum, and these values will be compared. In our study, we aimed to
      investigate the effect of pneumoperitoneum applied on acute kidney injury in patients who
      underwent laparoscopic surgery. Creatinine and NGAL have been used successfully in the
      follow-up of acute kidney injury. Our study investigates whether IGF-1 will be an effective
      indicator in acute kidney injury by comparing IGF-1 and NGAL values before pneumoperitoneum,
      after pneumoperitoneum and at the postoperative 24th hour.
    


Intervention name(s): IGF-1
Intervention type(s): Diagnostic Test
Intervention description(s): We need to diagnose acute kidney injury in the early postoperative period. The markers examined so far do not provide enough information to diagnose acute kidney injury early. For this reason, many different biomarkers are used in the early diagnosis of acute kidney injury in many parts of the world. Thanks to our research, we can recognise the development of acute kidney injury at an early stage and determine whether a previously unused biomarker (IGF-1) is effective in the early diagnosis of acute kidney injury.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Breast Cancer Prevention Education
Condition: Breast Cancer Prevention
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      We will develop and evaluate a community-based approach for disseminating comparative
      effective reviews (CERs) about breast cancer prevention to African American women. The
      specific aims of our research, as shown below, will target this population because of
      persistent disparities in breast cancer morbidity and mortality among this population. Our
      primary aims are:

        1. To evaluate uptake of a community-based strategy for disseminating CERs about breast
           cancer prevention to African American women based on sociodemographic characteristics,
           beliefs about medical research, and medical history. We predict that participation in a
           community forum will be higher among women with greater socioeconomic resources, those
           who have a family history of breast cancer, and women who have more positive beliefs
           about research.

        2. To evaluate the impact of evidential versus non-evidential content about breast cancer
           prevention on psychological and behavioral outcomes that include: knowledge of breast
           cancer risk factors and prevention strategies, communication with individuals in their
           social and medical network, and distrust of medical research. We predict that women who
           receive evidential content that is specific for African American women will report
           greater knowledge about breast cancer risk factors and prevention strategies, will be
           more likely to discuss breast cancer prevention strategies with individuals in their
           social and medical network, and will report greater reductions in distrust of medical
           research compared to those who receive non-evidential content.
    


Intervention name(s): Comparison of evidential versus non-evidential education on women's breast cancer prevention behaviors
Intervention type(s): Behavioral
Intervention description(s): Participants will be randomized to either the evidential or non-evidential group. Both groups will receive primarily the same information, except one group will receive information that is more tailored to African American women, while participants in the other group will receive general information about breast cancer prevention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: breast cancer; breast cancer prevention; African American women
Study Evaluating Etanercept in Patients With Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will assess the efficacy of etanercept for the treatment of Ankylosing Spondylitis
      (AS).
    


Intervention name(s): etanercept
Intervention type(s): Drug
Intervention MeSH terms: Etanercept
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment