bioihbjkbjnl/mcl2 huggingface dataset:
Postoperative Folfox4 Only Versus Folfox4 Plus Transhepatic Arterial Chemotherapy (TAC) in the Treatment Unresectable Liver Metastasis of Colorectal Cancer
Condition: Unresectable Liver Metastasis of Colorectal Cancer
MeSH terms: Colorectal Neoplasms; Neoplasm Metastasis; Liver Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate whether TAC plus FOLFOX4 are able to improve
      resection rate and overall survival in patients receiving primary colorectal tumor resection
      than given FOLFOX4 only.
    

Detailed description: 
      We administered three cycles FOLFOX4 plus on TAC (oxaliplatin, FUDR and MMC) or FOLFOX4 only
      to primary colorectal tumor resected patients with unresected liver metastasis. The study
      endpoints were resection rate of liver metastasis, progression-free survival, overall
      survival as evaluated by intent-to-treat analysis.
    

Intervention name(s): tac + folfox4; Folfox4
Intervention type(s): Procedure; Procedure
Intervention description(s): tac: oxaliplatin 100mg + fudr 1g + mmc 10mg
folfox4
Folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle. After 3 cycles, patients will received transhepatic arterial chemotherapy(TAC) using oxaliplatin, fudr and mmc. Then begin folfox4 again.; folfox4
Folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: liver metastasis; colorectal cancer
Group Based Treatment for Persons With Social Communication Difficulties
Condition: Brain Injuries
MeSH terms: Brain Injuries
Study type: Interventional

Summary: 
      A large proportion of patients with ABI have cognitive deficits that affect the way they
      communicate. Cognitive difficulties with attention, memory, executive functions and so on
      affect social communication. Without successful social skills, a person may engage in
      conflicts, become isolated and be denied access to social and vocational opportunities.
      Internationally, several group interventions have been developed for treating social
      communication difficulties during the last years.

      Group Interactive Structured Treatment (GIST) is a validated holistic multidisciplinary group
      treatment targeting social communication skills after traumatic brain injury. The main aim of
      the present study is to examine the efficacy of GIST for improving social communication in
      persons with acquired brain injury, including TBI, stroke, tumor ect. Secondary the study
      aims to compare the standard GIST protocol to an newly developed intensive GIST protocol.
      Efficacy will be assessed immediately after intervention, but also three and six months after
      the intervention. The project is in line with international research efforts aimed to
      establish more knowledge about group treatment for persons with social communication
      disorders after ABI.
    


Intervention name(s): Standard GIST; Intensive GIST
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 13 group modules will be administered to outpatients in 12 x 2,5-3 hours sessions. Manualized intervention; In every group session a new topic is presented, discussed and practiced in group exercises. Homework assignments between sessions.; 13 group modules will be administered to inpatients during 4 weeks in hospital. Participants is admitted to a hospital unit for cognitive rehabilitation treating patients in acute and/or cronic phase. The participants are given extended leave every weekend to work on homework Assignments between each treatment week.
Other intervention name(s): GIST; GIST
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adults; rehabilitation; social communication disorder; cognitive communication disorder; groups; evidence-based
An A Study Assessing Subject Satisfaction With A-101 Topical Solution for Seborrheic Keratoses
Condition: Seborrheic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis; Keratosis, Seborrheic
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is an open-label study designed to evaluate subject's satisfaction after treatment
      of seborrheic keratoses with A-101 40%.
    


Intervention name(s): A-101 Topical Solution
Intervention type(s): Drug
Intervention description(s): A-101 Topical Solution applied Day 1, Day 15 and Day 29
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Columbia
Condition: Growth Disorders
MeSH terms: Growth Disorders
Study type: Observational

Summary: 
      This is a Columbian, Multicentre, Observational Study to evaluate Adherence and Long Term
      Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth
      hormone treatment and to assess the level of adherence of subject receiving SAIZEN® via
      easypod™.
    

Detailed description: 
      Subjects will be enrolled in a multicenter longitudinal observational study. Parents/subjects
      will provide their Informed Consent/assent to upload their data for population-based analyses
      and, ultimately, clinical outcomes. Adherence data will be primarily derived from the
      easypod™ device combined with physician data entry of outcome measures. Data will be
      collected both retrospectively and prospectively. This will allow the establishment of
      adherence profiles and explore the hypothesis that patient adherence support programs improve
      adherence and subsequent clinical outcomes. Collected data will be also analyzed in a
      multinational pooled analysis of comparable national studies.

      Primary Objective:

      • To assess the level of adherence of subjects receiving SAIZEN® via easypod™

      Secondary Objectives:

        -  To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN®
           via easypod™

        -  To identify adherence subject profiling

        -  To assess the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above,
           below or within normal ranges)
    

Intervention name(s): easypod™
Intervention type(s): Device
Intervention description(s): Saizen (Somatropin) as per Summary of Product Characteristics administered by easypod™
Other intervention name(s): Saizen; Somatropin
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Paediatric subjects (aged 2-18) who are taking SAIZEN® for registered indications using the
        easypod™ electromechanical device.
      
Keywords: Growth disorders; Saizen; Easypod; Growth hormone; Pediatric subject
MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism
Condition: Prostate Cancer; Metabolic Syndrome; Hypogonadism; Fatty Liver
MeSH terms: Prostatic Neoplasms; Fatty Liver; Metabolic Syndrome; Hypogonadism
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate if androgen deprivation therapy in men with
      prostate cancer increases hepatic fat content and changes visceral/subcutaneous fat
      distribution.
    

Detailed description: 
      This is a substudy of the ongoing randomized trial entitled: Metabolic Changes Due to
      Iatrogenic Hypogonadism in Patients With Prostate Cancer: Orchiectomy vs. Triptorelin
      (EudraCT number: 2013-002553-29). 20 consecutive patients are anticipated to participate
      regardless of assignment to either orchiectomy or triptorelin.
    

Intervention name(s): Triptorelin; Orchiectomy
Intervention type(s): Drug; Procedure
Intervention description(s): Androgen deprivation therapy by Pamorelin 22,5mg/24 weeks administered intramuscularly.; Androgen deprivation therapy by bilateral subcapsular orchiectomy
Other intervention name(s): Pamorelin; Subcapsular orchiectomy
Intervention MeSH terms: Triptorelin Pamoate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Strategies for Reducing Sperm DNA Fragmentation in ICSI Semen Samples: a Prospective Randomized Controlled Trial
Condition: Male Infertility
MeSH terms: Infertility; Infertility, Male
Study type: Interventional

Summary: 
      Comparing second ejaculate and physiological ICSI (PICSI) as strategies for improvement of
      abnormal sperm DNA fragmentation in patients undergoing ICSI.
    

Detailed description: 
      Sperm DNA fragmentation has shown a negative correlation with embryo quality, fertilization,
      implantation, clinical pregnancy, and live birth rates. And a positive correlation with the
      miscarriage rate. Abnormal sperm DNA fragmentation can be improved through the second
      ejaculate strategy, by limiting the time of sperm presence in the epididymis. PICSI is a
      robust sperm selection technique that can select individual mature intact sperm DNA. In our
      study, we will compare PICSI as a valid sperm selection technique to second ejaculate, as a
      natural cost-free strategy to manage abnormal SDF. In addition to a normal SDF arm as a
      control.
    

Intervention name(s): PICSI; Second ejaculate
Intervention type(s): Device; Other
Intervention description(s): Semen processing by density gradient centrifugation followed by sperm selection by PICSI dishes of the first ejaculate; Semen processing by density gradient centrifugation for the second ejaculate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sperm DNA fragmentation; Second ejaculate; Sperm Selection; PICSI
Safety and Immunogenicity of a Monovalent Conjugated Vaccine Against Haemophilus Influenzae Type b
Condition: Haemophilus Influenzae Type b
MeSH terms: Influenza, Human; Haemophilus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will investigate safety and immunogenicity of a monovalent conjugated vaccine
      against Haemophilus influenzae type b in healthy children aged 2 to 4 months in China.
    


Intervention name(s): Haemophilus influenzae type b vaccine; Commercial Haemophilus influenzae type b vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 3 doses one month apart of Monovalent conjugated vaccine against Haemophilus influenzae type b vaccine; 3 doses one month apart of Haemophilus influenzae type b vaccine.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: vaccine; prevention; haemophilus influenzae type b; children
Safety, Efficacy and Tolerability of Vilazodone in Patients With Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone
      relative to placebo in the treatment of generalized anxiety disorder (GAD).
    


Intervention name(s): Placebo; Vilazadone
Intervention type(s): Drug; Drug
Intervention description(s): Viibryd
Other intervention name(s): Dose-matched placebo tablets, oral administration, once per day; Vilazadone once per day, 20 mg dose, oral administration or Vilazadone once per day, 40 mg dose, oral administration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Generalized Anxiety Disorder; GAD
Study in Healthy Adults to Quantify Lung Deposition and Distribution of Radio-labelled S-770108 Inhalation Powder Formulation Delivered by a Novel Inhaler Device
Condition: Healthy Volunteer
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the total lung deposition of radiolabelled
      S-770108 inhalation powder formulation after each of two separate single inhaled doses in
      healthy adult participants at two different target peak inspiratory flow rates (PIFRs)
    


Intervention name(s): Radio-labelled S-770108; S-770108 Inhaler A1
Intervention type(s): Drug; Device
Intervention description(s): 99mTc radio-labelled S-770108 supplied as a capsule containing 6 mg active pirfenidone for inhalation; Dry powder inhaler
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
The Influence of Water and Salt Intake on Copeptin Levels During Moderate Alcohol Consumption
Condition: Alcohol Drinking
MeSH terms: Diabetes Insipidus; Alcohol Drinking
Study type: Interventional

Summary: 
      The main interest of this study is to investigate the influence of moderate alcohol
      consumption (beer) on salt-water homeostasis. Therefore, 10 healthy volunteers will
      participate in 4 Intervention:

        -  Beer alone

        -  Beer and water

        -  Beer and salt (stock/bouillon)

        -  Water alone During the study day, copeptin, sodium, osmolality and urinary
           sodium/osmolality will be measured at 6 timepoints.
    


Intervention name(s): Beer 5%o; Beer 8.5%o and water; Beer 8.5%o and stock; Water
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Weight adjusted beer to reach 0.8 blood alcohol content will be given over the time course of 1 hour to the participants; Weight adjusted beer to reach 0.8 blood alcohol content and water will be given over the time course of 1 hour to the participants; Weight adjusted beer to reach 0.8 blood alcohol content and stock will be given over the time course of 1 hour to the participants; Water equivalent to the calculated volume of beer will be given over the time course of 1 hour to the participants
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Copeptin; Salt-water homeostasis
A Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of Single Doses of Q203 in Normal, Healthy, Male and Female Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomized, double-blind, placebo-controlled, dose-escalation study in healthy male and
      female volunteers. Subjects will be randomly assigned to 1 of 7 treatment cohorts (Cohorts 1
      - 7) of 8 subjects each, to receive either Q203 or placebo (6 active treatment : 2 placebo)
      in a fasting state.

      Dose escalation to the next cohort may be considered when at least 6 out of 8 subjects, in a
      cohort, completes all procedures and none of the subjects has a clinically significant
      adverse event (AE) that is being followed, or at the discretion of the PI if no drug-related
      serious adverse events (SAEs) have occurred.

      A food effect cohort will be enrolled to test administration of Q203 in a fed state, at 100
      mg dose level (this dose level may change based on PK analysis results). Subjects who
      received 100mg dose in a fasting state will return and receive the second dose, with food.

      Subjects will be followed up for AEs, SAE or pregnancy for 30 days postdrug administration.
    

Detailed description: 
      Randomized, double-blind, placebo-controlled, dose-escalation study in healthy male and
      female volunteers. Subjects will be randomly assigned to 1 of 7 treatment cohorts (Cohorts 1
      - 7) of 8 subjects each, to receive either Q203 or placebo in a fasting state. Every attempt
      will be made to include at least 2 females in each cohort, at least one of whom will be
      assigned to receive Q203.

      Dose escalation to the next cohort may be considered when at least 6 out of 8 subjects, in a
      cohort, completes all procedures and none of the subjects has a clinically significant
      adverse event (AE) that is being followed, or at the discretion of the PI if no drug-related
      SAEs have occurred. A food effect cohort will be enrolled to test administration of Q203 in a
      fed state, at 100 mg dose level (this dose level may change based on PK analysis results).
      Subjects who received 100mg dose in a fasting state will return and receive the second dose,
      with food. In this cohort, all eight subjects will proceed to receive either Q203 or placebo
      in a six to two ratio (six active treatment : 2 placebo). Every attempt will be made to
      include at least 2 females in this cohort, at least one of whom will be assigned to receive
      Q203.

      Subjects will be followed up for AEs, SAE or pregnancy for 30 days postdrug administration.
    

Intervention name(s): Q203; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of a Cocoa Shot on the Human Brain
Condition: Caffeine; Flavonoids
Study type: Interventional

Summary: 
      The Hershey Company is interested in investigating the effects of various chocolate beverages
      on brain physiology and cognitive function. The main substances in the drinks that are known
      to influence the brain are caffeine (and related chemicals such as theobromine) and
      flavonoids. Flavonoids are chemical found in plants and are most commonly associated with
      antioxidant activity. Caffeine, chemicals related to caffeine, and flavonoids are all
      naturally occurring and all potentially alter brain physiology. This study will evaluate
      changes in brain blood flow and cognition following the consumption of drinks with various
      combinations of the Primary Ingredients. Caffeine is likely to have peak effects within
      1-hour of ingesting the chocolate while the flavonoids are likely to have peak effects 3-4
      hours after ingestion. The study proposed here will evaluate ingredients in a 4-arm
      cross-over double-blind design in an attempt to understand the differential effects of these
      compounds in chocolate drinks.
    


Intervention name(s): High Caffeine; Low caffeine; High theobromine; low theobromine; No theobromine
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Theobromine; Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Caffeine; Flavonoids; MRI; Brain blood flow; Cognition; Perfusion; Resting functional magnetic resonance imaging (fMRI)
Endometrial Biopsy in Infertile Patients
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      When a woman becomes pregnant, the fertilized egg attaches itself to the lining of the uterus
      (endometrium). The endometrium is constantly changing throughout a woman's menstrual cycle in
      response to the female hormones estrogen and progesterone. The endometrium must have certain
      characteristics (be at a specific phase in its cycle) in order for the fertilized egg to
      successfully attach. Infertility may be caused by an "out of phase" endometrium (i.e., the
      endometrium doesn't have the right characteristics when the fertilized egg reaches it). The
      purpose of this study is to evaluate whether the endometrial biopsy is useful in predicting
      the potential for becoming pregnant and bearing a child.
    

Detailed description: 
      This study will evaluate the utility of the endometrial biopsy as a tool for the routine
      evaluation of the luteal phase of women presenting for infertility evaluation. The study will
      establish whether the mid-luteal or late-luteal phase is the most appropriate time to perform
      an endometrial biopsy. The study will be conducted through the multi-center Reproductive
      Medicine Network.

      Women with a history of infertility will be age matched to fertile women (controls). Women
      will be randomized either to the mid-luteal phase (7 to 8 days post-ovulation) endometrial
      biopsy group or to the late-luteal phase (12 to 13 days post-ovulation) endometrial biopsy
      group. Endometrial specimens will be evaluated histologically by a "blinded" pathologist.
    

Intervention name(s): Endometrial biopsy
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Diagnostic
Keywords: Endometrium; Luteal phase; Endometrial biopsy
C-MAC Videolaryngoscope for Insertion of a Transesophageal Echocardiography Probe in ICU Patients
Condition: Critical Illness
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      Transesophageal echocardiography (TEE) is commonly used in operating room (cardiac surgery),
      as well as in other critical care settings. A recent meta-analysis including only three
      randomized studies demonstrated that the use of a videolaryngoscope for transesophageal
      echocardiography probe insertion in anesthetized patients undergoing open cardiac surgery was
      associated with a significant reduction in the number of attempts. insertion and
      complications rate, compared with blind insertion or a laryngoscope-assisted insertion.

      ICU patients are usually intubated, with multiple complications, requiring high doses of
      catecholamines, and with frequent coagulation disorders. Many of these patients, during their
      stay in the ICU, require a transesophageal echocardiogram. On multiple occasions, due to the
      critical situation of the patients, due to edema, and coagulation alteration, the placement
      of the echocardiography probe can be difficult, leading to complications, such as gastric
      bleeding or lesions in the oropharyngeal mucosa.

      To avoid complications during the insertion of the TEE tube, the investigators consider it
      necessary to introduce it in the fewest possible attempts.

      The primary aim of the present study was to compare the success rate of TEE probe insertion
      at the first attempt betweenn the C-MAC videolaryngoscope assisted insertion and the blind
      insertion technique.

      The secondary aim was to compared differences between the 2 groups in the incidence of
      complications ( oropharyngeal mucosal injury, hematoma, ….), overall success rate, the number
      of insertion attempts, and the duration of insertions.
    

Detailed description: 
      One hundred intubated ICU adult patients that require transesophageal echocardiography
      insertion, will be randomized by means of a computer-generated randomization order into two
      groups: Conventional group (Group Blind), and videolaryngoscope group (group C-MAC).

      Success rate of the selected technique (first attempt), overall success rate, number of
      attempts, complications, and duration of insertion for technique will be noted.
    

Intervention name(s): Blind insertion technique; C-MAC videolaryngoscope insertion technique
Intervention type(s): Device; Device
Intervention description(s): Transesophageal echocardiography probe will be inserted using a conventional blind insertion technique.; Transesophageal echocardiography probe will be inserted using a C-MAC videolaryngoscope insertion technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: transesophageal; echocardiography; videolaryngoscope;