bioihbjkbjnl/mcl2 huggingface dataset:
Tumor Cells, Tumor DNA and Immunological Response in Colonic Stent Placement
Condition: Cancer of Colon
MeSH terms: Colonic Neoplasms
Study type: Observational

Summary: 
      This study aims to investigate levels of circulating cell free DNA (cfDNA), circulating tumor
      DNA (ctDNA), circulating tumor cells (CTC) and immunological changes after self-expanding
      metal stent (SEMS) placement for malignant obstruction in the colon, and interpret these
      levels in relation to overall- and disease-free survival.

      Furthermore, we intend to study the opportunity to identify patients with a higher risk of
      recurrence due to the SEMS placement by monitoring cfDNA and ctDNA-levels, as it may be a
      potential biomarker to initiate or optimize chemotherapy and thereby ensure a better
      prognosis for the patients.
    

Detailed description: 
      Study design This prospective study will include 20 patients undergoing SEMS placement as a
      bridge to elective surgery at Koege- and Slagelse Hospital. Baseline blood samples will be
      collected before the procedure. After the procedure blood samples will be collected 1, 4, 12
      and 24 hours after SEMS placement. After elective surgery a tumor sample will be collected.

      Prior to SEMS placement:

      When potential candidates are admitted to the hospital they will be presented to the study by
      the relevant surgeon. The investigators will be contacted, when the patient is admitted to
      hospital.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        We intend to include 20 patients with malignant obstruction who are treated with a
        colorectal stent as bridge to surgery or as palliation.
Long-pulsed 1064 nm Nd-YAG Laser Versus TCA 20% in Treatment of Keratosis Pilaris
Condition: Keratosis Pilaris
MeSH terms: Keratosis, Actinic; Abnormalities, Multiple; Darier Disease; Keratosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Keratosis pilaris (KP) is a common disorder of keratinization. There are different treatment
      modalities for KP with variable results. Nd:YAG laser and chemical peels are among these
      treatment modalities, however, there is no enough evidence in the literature regarding their
      efficacy. The aim of this study is to assess and compare the efficacy of long pulsed Nd:YAG
      laser and trichloreacetic acid 20% in treatment of keratosis pilaris.
    

Detailed description: 
      Keratosis pilaris (KP) is a genetic disorder of keratinization of hair follicles of skin.
      It's a very common benign condition that manifests as small, rough folliculocentric keratotic
      papules, often described as chicken bumps, chicken skin or goose-bumps, in characteristic
      areas of body, particularly the outer upper arms and thighs.

      Trichloreacetic acid (TCA) is a type of chemical peels that is derived from acetic acid by
      the chlorination of 3 hydrogen ions. It can induce coagulative necrosis of proteins and
      cells. The depth of action depends on various factors e.g the number of layers applied and
      its combination with substances that potentiate its action.

      Nd: YAG laser is a type of hair removing devices that operates at wave length of 1064nm. This
      wave length allows for less absorption at the epidermis. It is less absorbed by melanin,
      which leads to lower side effect and better tolerance but less efficacy in dark skinned
      patients.
    

Intervention name(s): Nd-YAG laser; TCA 20%
Intervention type(s): Device; Drug
Intervention description(s): laser hair removal device; chemical peel
Other intervention name(s): 1064 nm laser; Trichloroacetic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of Consumption of Dairy Product on Upper Gastric Discomfort
Condition: Upper Gastric Discomfort
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the consumption of test dairy products is
      effective in reducing upper gastric discomfort after 2 weeks of product consumption.
    


Intervention name(s): 1- Test dairy product containing specific ingredients; 2- Control dairy product without specific ingredients
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: dairy product; upper gastric discomfort; adult
Effect of Cholecalciferol, Soy Isoflavones in Patients With Irritable Bowel Syndrome
Condition: Irritable Bowel Disease
MeSH terms: Irritable Bowel Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Fasting blood specimens will be taken from the patients with IBS that have inclusion
      criteria. First, the objectives and method of study will be explained to the patients and
      informed consent form will be taken from them. They will be divided into 4 groups by an
      adjusted randomized blocking and the clinical outcomes, quality of life, emotional stress
      questionnaires will be completed before and after intervention. During 6 weeks, they will
      receive 2 capsules of soy isoflavones per day, 50000IU vitamin D biweekly in addition to the
      other placebo form, both of them and placebo of both. At the end, body mass index ( BMI),
      serum TNF-Alpha, TAC, gene expression of GATA3, ROR gamma, FOXP3 in lymphocytes and gut
      permeability will be measured. The quantity of polymorphisms of vitamin D and estrogen
      receptors will be determined.
    


Intervention name(s): Soy isoflavones; cholecalciferol; Placebo of soy isoflavones; placebo of cholecalciferol
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Other intervention name(s): Vitamin D
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Documentation of Altered Mental Status
Condition: Altered Level of Consciousness
MeSH terms: Consciousness Disorders
Study type: Observational

Summary: 
      Altered mental status (AMS) is common in older patients. However there is a lack of
      standardization in the definition and documentation of this compliant. Different perception
      of AMS can cause negative impact on interpretation and obtaining scientific data. Although
      definition of AMS is so complicated, clinical documentation can be detected in these patients
      with AMS.
    

Detailed description: 
      Basically, consciousness is the state of full awareness of the self and one's relationship to
      the environment. There are 2 related areas of neurologic function that are connected to
      consciousness: content (orientation and memory) and level (arousal and response to stimuli).

      The mental changes are best looked for in terms of arousal, attention, alertness,
      orientation, cognition, memory, affect, and perception. Arousal (level of consciousness) can
      be detected by the Richmond Agitation and Sedation Scale. Others are related to content of
      consciousness and can be evaluated by cognitive tests. After one month pilot study, the
      investigators chose 5 features of content of consciousness due to easy applicable and
      detectable;

        1. Attention (counting numbers backwards from 20) (>1 error positive)

        2. Cognition (disorganized thinking; meaningless speech, irrelevant explanations)

        3. Perception (visual or auditory hallucinations)

        4. Memory (3 items recall) (>1 error positive)

        5. Orientation (day of week, month and year) (>1 error positive)

      These features are also combination of six item screener test and delirium symptoms.

      All elderly patients (65 aged and older) presented to the emergency department, will be
      assessed according to these two methods; content and level of consciousness. And also, every
      patient's baseline status of consciousness will be obtained from surrogates who knows the
      patient best. All changes from patient's baseline status will be recorded. The investigators
      will investigate how changes are reflected in the clinic.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All older emergency department patients aged 65 and older.
      
Keywords: documentation; altered mental status; definition; clinically
A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Evolve)
Condition: Acromegaly
MeSH terms: Acromegaly
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2 double-blind, placebo-controlled, randomized withdrawal study is designed to
      evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808; an
      oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with
      acromegaly that are responders to octreotide LAR or lanreotide depot.
    


Intervention name(s): Paltusotine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Paltusotine, capsules, once daily by mouth; Placebo, capsules, once daily by mouth
Other intervention name(s): CRN00808
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Acromegaly; ACROBAT; EVOLVE; Paltusotine
Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated With Zidovudine
Condition: HIV Infections; Pregnancy
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      To identify patterns of zidovudine ( AZT ) susceptibility among mother/infant pairs with
      perinatal HIV transmission.

      Most HIV-infected infants acquire their disease via perinatal transmission. Since
      transmission of HIV-resistant strains to infants could alter the course of disease and
      response to currently recommended treatment, a study to assess the patterns of AZT
      susceptibility among mother/infant pairs with perinatal transmission is essential to
      delineate future therapeutic strategies.
    

Detailed description: 
      Most HIV-infected infants acquire their disease via perinatal transmission. Since
      transmission of HIV-resistant strains to infants could alter the course of disease and
      response to currently recommended treatment, a study to assess the patterns of AZT
      susceptibility among mother/infant pairs with perinatal transmission is essential to
      delineate future therapeutic strategies.

      HIV-infected pregnant women are enrolled at 20-36 weeks gestation. Patients have blood drawn
      for HIV culture at study entry and at delivery. Infants have blood drawn for HIV culture at
      delivery and at 1, 3, 6, and 18 months of age.
    

Keywords: Pregnancy; Pregnancy Complications, Infectious; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Zidovudine; Drug Resistance, Microbial; Disease Transmission, Vertical
A Single Ascending Dose Study To Evaluate Safety And Pharmacokinetics Of Compound PF-06648671 In Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is first in human (FIH), double-blind, sponsor open, placebo-control trial to examine
      the safety, tolerability, pharmacokinetics and pharmacodynamics following a single ascending
      doses of PF-06648671 in healthy subjects.
    


Intervention name(s): PF-06648671; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Experimental Pfizer compound which will be dosed as oral suspension; Placebo which will be given as oral suspension
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Phase 1, Single-Dose Escalation, Double Blind, Placebo-Controlled, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, PF-06648671, Plasma Abeta
Targeted Evaluation, Action, & Monitoring of Traumatic Brain Injury
Condition: Traumatic Brain Injury (TBI)
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional

Summary: 
      TEAM-TBI (Targeted Evaluation, Action, and Monitoring of Traumatic Brain Injury) is a
      research study that brings together TBI patients, advanced evaluation methods, and experts in
      a multi-faceted study to address the heterogeneity of TBI and to evaluate the effects
      self-help strategies might have on TBI outcomes.
    

Detailed description: 
      TEAM-TBI (Targeted Evaluation, Action, and Monitoring of Traumatic Brain Injury) proposes a
      new approach to clinical trials in TBI that will:

        -  Evolve diagnostic technology & treatment

        -  Improve self-help strategies

        -  Lower cost and speed for delivery of effective strategies

      The TEAM-TBI program proposes an innovative new approach to TBI clinical trials to overcome
      the limitations of past efforts and achieve long-awaited breakthroughs for TBI survivors. The
      study will involve a comprehensive 3-4 day intake evaluation, followed by a variety of
      remotely performed tasks during a 1-6 month follow-up period.
    

Intervention name(s): Cognitive/Neuropsychological Testing; Vestibular/Ocular-Motor Testing; Cervical (Neck) Evaluation; Sleep Evaluation; HDFT MRI; MR Spectroscopy (MRS); MEG (Magnetoencephalography)
Intervention type(s): Behavioral; Other; Other; Other; Other; Other; Other
Intervention description(s): These tests will be used to determine how the participant will continue with future procedures, and depending on results, may involve the participant returning to complete subsequent testing.; These assessments will involve a series of tests and questionnaires that focus on physical symptoms of TBI and will include dizziness, balance, ocular-motor coordination, and reflexes.; These assessments will involve a series of tests and questionnaires that focus on physical symptoms of TBI including neck mobility and pain levels.; These evaluations will focus on assessing insomnia (duration, frequency, daytime consequences), combat exposure, and the presence and severity of trauma history.; This MRI aims at providing qualitative and quantitative assessments of the nature, location, and extent of white matter injury.; This is a noninvasive diagnostic test for measuring biochemical changes in the brain.; This is a non-invasive neurophysiological technique that measures the magnetic fields generated by neuronal activity of the brain.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Effect Evaluation of the Work Rehabilitation Effort "Best iLag"
Condition: Musculoskeletal Pain; Work Related Illnesses; Burnout, Professional
MeSH terms: Musculoskeletal Pain; Burnout, Professional
Study type: Interventional

Summary: 
      The study compares the effect of a group-based activity with an individual work-out activity
      on work participation.
    

Detailed description: 
      The study is an RCT comparing the effect of a group-based intervention with an individual
      work-out intervention on work participation. The target group is persons who are at risk of
      leaving the work force due to health issues, and people currently outside the work force. The
      interventions have a time-span of 3 months. Survey data will be collected at baseline, after
      three months (after intervention has ended), and after 15 months. Survey data include
      information on lifestyle, self-reported health, subjective health complaints and readiness
      for work. Register data on employment and welfare benefits will be collected from two years
      in advance of inclusion, and five years after inclusion. According to power calculations, the
      study will need 322 participants.

      In addition to the effect evaluation, a process evaluation will also be performed. The
      process evaluation will examine content quality and adherence to guidelines, as well as
      feasibility of the group intervention. The process evaluation will consist of some survey
      data as well as interviews with service providers and participants.
    

Intervention name(s): Group-based activity; Individual activity
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Regular follow-up from welfare authority as well as a 3 month group activity with weekly gatherings, focusing on coping, goal-setting and relevant information regarding available public services.; Regular follow-up from welfare authority as well as a 3 month membership card at a given gym.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Return to work; Work rehabilitation; Sick-leave
Safety and Efficacy of Ultra-Rush Sublingual Immunotherapy in Children With Asthma Allergic to Grass Pollen
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to assess the safety and efficacy of sublingual immunotherapy applied
      preseasonal and seasonal in ultra-rush scheme in children with bronchial asthma allergic to
      grass pollen. The investigators will assess clinical symptoms, reliever drugs usage, lung
      function, chosen markers of allergic inflammation, bronchial hyperreactivity with
      methacholine, and presence and type of allergy after two years of sublingual immunotherapy
      (SLIT) in children with asthma.
    

Detailed description: 
      Specific immunotherapy is the only causal treatment method of atopic diseases including
      bronchial asthma in children. Sublingual immunotherapy seems to be the most promising
      alternative to traditional specific subcutaneous injection immunotherapy.

      The aim of the study is to assess the safety and efficacy of sublingual immunotherapy applied
      preseasonal and seasonal in ultra-rush scheme in children with bronchial asthma allergic to
      grass pollen. We will assess clinical symptoms, reliever drugs usage, lung function, chosen
      markers of allergic inflammation, bronchial hyperreactivity with methacholine, and presence
      and type of allergy after two years of SLIT in children with asthma.

      After two years the study will be unblinded, all the children will be given grass pollen
      allergen extract for a year.
    

Intervention name(s): Staloral 300; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Staloral 300; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Asthma; Sublingual immunotherapy; Children
In Vitro Effects of Procyanidine on Semen Parameter and DFI
Condition: Spermatogenesis and Semen Disorders; DNA Double Strand Break
Study type: Interventional

Summary: 
      Proanthocyanidins are a class of polyphenols found in a variety of plants that have
      antioxidant activity in vitro, which is stronger than vitamin C or vitamin E.

      Several studies have been performed evaluating the administration of antioxidant therapy in
      the form of oral antioxidant supplementation or in vitro addition of antioxidant to culture
      media during assisted reproductive techniques (ART).

      However, the impact of in vitro addition of proanthocyanidins to semen has not been studied
      yet. The research question evaluated in the current study was whether semen samples of
      infertile men supplemented or not with procyanidine immediately after their production,
      differ in semen parameters, sperm DFI.
    


Intervention name(s): procyanidine
Intervention type(s): Dietary Supplement
Intervention description(s): natural antioxidants
Intervention MeSH terms: Procyanidin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
The Prevalence of Secondary Adrenal Insufficiency in Patients With Exacerbation of COPD in Glucocorticoid Treatment Related to Differenct Gene Polymorphisms of the Glucocorticoid Receptor Gene
Condition: Adrenal Insufficiency
MeSH terms: Adrenal Insufficiency
Study type: Observational [Patient Registry]

Summary: 
      To investigate the correlation between four well-known polymorphisms of the glucocorticoid
      receptor gene (two with reduced sensitivity versus two with increased sensitivity) and the
      prevalence of secondary adrenal insufficiency in glucocorticoid-treated patients with
      exacerbation of COPD.
    

Detailed description: 
      COPD patients who have received systemic glucocorticoid exceeding the equivalent of 180 mg
      prednisolone which are homo / heterozygous for the BclI and / or N363S polymorphisms
      (associated with increased glucocorticoid sensitivity) will have a lower cortisol response in
      a synacthen® test (greater suppression of adrenal corticosteroid) than the corresponding
      patients there are wild-type or homo- or heterozygous for the polymorphic ER22 / 23EK and /
      or 9β (associated with decreased sensitivity). Information from the results of the
      investigation will be able to help clinicians to identify patients with acute exacerbation of
      COPD (AECOPD) at risk of of secondary adrenal insufficiency.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        78 hospitalised patients with exacerbation of COPD
      
Biospecimen description: 
      Blood samples and DNA from gene analyses
Extension Clinical Study to Evaluate the Long-term Efficacy and Safety of Repeat Treatment of YVOIRE Contour Injected Into the Anteromedial Malar Region in Subjects Who Have Completed the LG-HACL014 Study
Condition: Normal, Healthy Adults With Moderate, Severe, or Very Severe Volume Loss of Anteromedial Malar Region Who Have Completed the LG-HACL014 Study
Study type: Interventional

Summary: 
      This study is purposed to evaluate the long-term efficacy and safety of repeat treatment of
      YVOIRE contour injected into the anteromedial malar region in subjects who have completed the
      LG-HACL014 study.
    


Intervention name(s): YVOIRE contour
Intervention type(s): Device
Intervention description(s): YVOIRE contour injection into the anteromedial malar region
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of LAPS-Exendin on Body Weight in Obese Population
Condition: Obesity
MeSH terms: Body Weight
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the optimal dose and regimen of HM11260C, in
      combination with a hypocaloric diet, to reduce weight in obese subjects who are otherwise
      considered in stable health.
    

Detailed description: 
      Phase 2 study
    

Intervention name(s): HM11260C; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Glucagon-like peptide-1 analogue
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment