bioihbjkbjnl/mcl2 huggingface dataset:
Preoperative Combined Radiochemotherapy for Patients With Rectal Carcinoma
Condition: Rectal Cancer
MeSH terms: Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      Rate of T-downstaging (Reduction of the T-stadium) at the time of final surgery following the
      preoperative combined radiochemotherapy (chemotherapy: Oxaliplatin, Capecitabine) Evaluation
      of the toxicity grade III and IV of the therapy scheme
    

Detailed description: 
      About 60 patients with locally advanced rectal carcinoma (cT3, Nx, M0) of the lower and
      middle rectum will be recruited.

      The radiotherapy is an essential part of therapy of the advanced rectal carcinoma and the
      additional administration of a chemotherapy will positively influence the effect of the
      therapy (downstaging-rate, rate of distant metastases, survival-rate). Probably a downsizing
      and downstaging (as per literature and by own experience) can be reached with an preoperative
      combined radiochemotherapy.
    

Intervention name(s): Capecitabine; Oxaliplatin
Intervention type(s): Drug; Drug
Intervention description(s): chemotherapy oral use; chemotherapy intravenous use
Other intervention name(s): Xeloda; RO 09-1978; treatment defined only by active substance; (no trade name defined; investigators choice)
Intervention MeSH terms: Capecitabine; Oxaliplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Preoperative; Radiochemotherapy; Newly Diagnosed; Primary Operable; Locally Advanced; Rectal Carcinoma; T3; Lower Rectum; Middle Rectum; ABCSG; TAKO; 95; 05
Response to Booster Doses of Hepatitis B Vaccine in Children and Adolescents
Condition: Hepatitis
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Observational

Summary: 
      The purpose of this study is to determine the immune response to an additional (booster) dose
      of hepatitis B vaccine 5-14 years after a three dose series was given
    

Detailed description: 
      Routine hepatitis B vaccination beginning at birth was provided to Alaska Natives several
      years before other areas of the United States began routine infant hepatitis B vaccination
      programs. Follow up studies of hepatitis B immunity among Alaska Native children provide an
      early opportunity to assess long term protection against hepatitis B virus (HBV) infection
      for children vaccinated at birth with the currently used recombinant vaccine. This protocol
      describes an evaluation of long-term protection against HBV infection among children who
      received the recombinant hepatitis B vaccine beginning at birth, and who currently receive
      medical care at the Alaska Native Medical Center (ANMC) in Anchorage, Alaska.

      The specific objective of this study is to evaluate the immune response to a five microgram
      dose of recombinant hepatitis B vaccine among 5-6 year old and 10-14 year old children who
      received the primary recombinant hepatitis B vaccine series beginning at birth. The
      concentration of antibodies to hepatitis B surface antigen (anti-HBs) will be measured
      immediately before administering the vaccine, and compared with levels in serum drawn 1, 2
      and 4 weeks afterwards. A rapid antibody response (anamnestic response) indicates that immune
      memory, and therefore immunity to HBV infection, is preserved. The frequency and magnitude of
      the anamnestic response for the group of older children will be compared to that of the
      younger group.

      Currently, there is no recommendation for a routine booster dose of vaccine after receiving
      three doses at birth. This study will provide valuable information regarding the need for and
      response to an additional dose (booster dose) of hepatitis B vaccine among children entering
      primary school or adolescence. If evidence of waning immune memory (as measured by a delayed
      or diminished response to the additional dose of vaccine) is found, these two age groups
      would be the most easily accessible for routine delivery of a booster dose.
    

Intervention name(s): hepatitis B vaccine
Intervention type(s): Biological
Time perspective: Prospective
Keywords: vaccine; hepatitis
Study of BPZE1 Intranasal Pertussis Vaccine (Administered Via VaxINator(TM)), Prime + Boost, in Healthy Adults
Condition: Pertussis; Whooping Cough
MeSH terms: Whooping Cough
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the safety and immunogenicity of the BPZE1 live attenuated pertussis
      vaccine, intended to prevent nasopharyngeal colonization and pertussis disease, and compares
      a single (prime) BPZE1 dose or BPZE1 2-dose (prime + boost) to a single (prime) Boostrix or
      Boostrix prime + BPZE1 boost.
    

Detailed description: 
      This study evaluates the safety and immunogenicity of the BPZE1 live attenuated pertussis
      vaccine, intended to prevent nasopharyngeal colonization and pertussis disease, and compares
      a single (prime) BPZE1 dose or BPZE1 2-dose (prime + boost) to a single (prime) Boostrix or
      Boostrix prime + BPZE1 boost. This is a multi-center, randomized, placebo-controlled, and
      observer blinded trial in healthy adults with a 6 month safety follow-up after the last
      vaccination.
    

Intervention name(s): BPZE1 pertussis vaccine and VaxINator(TM) Atomization Device
Intervention type(s): Combination Product
Intervention description(s): Live attenuated pertussis vaccine administered via the VaxINator(TM) atomization device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: pertussis; Bordetella infection; Gram-negative bacterial infection; Respiratory tract infection; Whooping cough; Infection; Respiratory tract disease; Vaccine; Immunological factors; Physiological effects of drugs
Ventilatory Muscle Training by Breath-Stacking in Healthy Youngsters
Condition: Muscle Weakness
MeSH terms: Muscle Weakness
Study type: Interventional

Summary: 
      In several diseases in which muscle weakness is a determining factor for morbidity and
      mortality, inspiratory muscle training has been shown to be useful in improving the function
      of ventilatory muscles, delaying or minimizing the development of complications due to the
      reduction of inspiratory muscle strength.

      The breath-stacking technique emerges as an easily applicable alternative, and it can be used
      in poorly collaborative patients. The technique described in the literature aims to increase
      pulmonary volumes.

      This gain occurs with the coupling of a silicone mask on the patient's face, a unidirectional
      valve and with the expiratory branch occluded. Thus, inspirations occur sequentially in this
      medium, generating pulmonary hyperinflation and increasing the contractility power of the
      expiratory muscles, which are fundamental for coughing. This hyperinflation also improves the
      peripheral air distribution in the lungs by increasing intrathoracic pressure.

      The objective of this study is to evaluate the effect of the breath-stacking (BS) technique
      on the ventilatory muscle strength of young and healthy individuals.
    

Detailed description: 
      Initially, participants will be submitted to a learning session on the evaluation of
      ventilatory muscle strength and the breath-stacking technique. Between 24-72 hours after the
      learning, the evaluation of the muscular muscular strength will be performed through the
      maximal inspiratory pressure (MIP) and the maximum expiratory pressure (MEP). PI max will be
      measured from a maximum expiration; While PE max will be measured from a maximum inspiration,
      using a digital manovacuometer (MVD 300®)
    

Intervention name(s): Breath-Stacking
Intervention type(s): Other
Intervention description(s): Participants will be seated, with their elbows resting on the table, holding the face mask attached to a T-tube and a one-way valve. They will be instructed to inspire and force the expiration inside the mask. The training will be conducted three times a week for a period of four weeks, totaling twelve sessions. The breath-stacking application protocol will consist of three three-minute series, with a three-minute recovery interval between each series, obtaining a total time of fifteen minutes in each session.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficacy and Safety Study of Propofol Infusion for Refractory Chronic Primary Insomnia
Condition: Insomnia; Sleep Disorder; Dyssomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Parasomnias; Dyssomnias
Study type: Interventional
Phase: Phase 1

Summary: 
      Insomnia is a widespread condition in which approximately one-third of adults in the United
      States are symptomatic with 6% of the population meeting the diagnostic criteria for
      insomnia. There is an increased risk of insomnia in certain segments of the population
      including women, middle-aged and older adults, shift workers and individuals with medical or
      psychiatric disorders. Individuals with insomnia have a decreased quality of life compared to
      those who report other serious illnesses such as major depression and congestive heart
      failure. Chronic insomnia can be caused by medications, drug or alcohol abuse, psychiatric
      disorders, medical and neurologic disorders. It can impair cognitive and physical
      functioning.

      Propofol is an approved drug administered intravenously for use in the induction and
      maintenance of anesthesia or sedation. Some research suggests that propofol when administered
      as a two hour infusion may improve the ease of sleep onset, sleep quality, ease of awakening
      and the integrity of behavior following waking.

      This study will be conducted in the Broward Health Medical Center Sleep Lab, under the direct
      care of a Board Certified Anesthesiologist, dedicated to the study involving participants who
      have refractory chronic primary insomnia and have not responded to conventional pharmacologic
      therapies within the past 90 days. Each qualifying participant will receive an IV infusion of
      the study medication for 5 consecutive nights. Assessments including polysomnography with
      completion of questionnaires will occur at screening, Days 1 through 5 of study product
      administration, Day 6 and Day 90. Follow-up questionnaires will also be distributed on Day
      180.
    


Intervention name(s): propofol injectable emulsion
Intervention type(s): Drug
Intervention MeSH terms: Propofol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Propofol; Insomnia; Sleep disorder; Sleep deprivation; Chronic insomnia; Refractory insomnia; Primary insomnia
The Effect of Trauma Informed Care in Childbirth
Condition: Psychological Well-being; Childbirth; Care Pattern, Maternal
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The aim of this study is to determine the effect of supportive care based on trauma informed
      care during childbirth on perinatal mental health outcomes.
    

Detailed description: 
      This is a randomized control experimental study. Data were collected from 100 women who
      attended supportive care based on trauma informed care or standart care from Turkey between
      July 2022 and September 2022. Participants who met the inclusion criteria were informed about
      the purpose of the study and the procedures to be performed, informed consent was obtained
      from those who agreed to participate, and women were assigned to the groups in line with a
      computer-based randomization program with an allocation ratio of 1:1. Block randomization
      could not be performed because of the different and long delivery processes. Data were
      collected in both groups at birth (latent phase, active phase, and transitional phase),
      within 24 hours of birth, and 6th-8th postpartum days after hospital admission and at least
      one hour of care. collected by the first author. The CONSORT directive was followed in the
      planning, implementation and writing of the research.
    

Intervention name(s): Experimental: Supportive Care based on trauma informed care; Standart care
Intervention type(s): Other; Other
Intervention description(s): Participants were provided care in different rooms, blinded to the differences in practice used between the two groups. In the same clinic, a room was designed as a positive delivery room by the researchers and a relaxing environment was created. In this room, supportive care based on trauma informed care was provided to the experimental group during birth.; Participants in the control group, on the other hand, received the routine care given in the hospital by other midwives in the clinic, and there was a change of caregiver midwife during shift changes. The care provided in the hospital during delivery is mostly focused on low level of physical comfort and high level of follow-up.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Intrapartum supportive care; Trauma Informed Care; birth trauma; fear of childbirth; perinatal well-being
Acute Effects of Naturally Occurring Tea and Coffee-based Ingredients on Cognitive Performance
Condition: Cognitive Change
Study type: Interventional

Summary: 
      This study is a double-blind, randomized, three-arm, single-dose, placebo-controlled
      crossover trial of forty (40) apparently healthy male and female participants. The objective
      of this study is to assess the effects of AmaTea Max Organic Guayusa Extract and Lion's Mane
      on cognitive responses including mental clarity, mood, focus, concentration, productivity,
      anxiety/stress, happiness, and accuracy.
    

Detailed description: 
      This study is a double-blind, randomized, three-arm, single-dose, placebo-controlled
      crossover trial of forty (40) apparently healthy male and female participants. The objective
      of this study is to assess the effects of AmaTea Max Organic Guayusa Extract and Lion's Mane
      on cognitive responses including mental clarity, mood, focus, concentration, productivity,
      anxiety/stress, happiness, and accuracy. Since these dietary supplements are on the market
      for consumer use, it is important to investigate and confirm their potential benefits,
      comparisons, and safety through further research.

      Subjects will attend 4 study visits. During Visit 1, subjects will be screened for
      participation (i.e., medical history, routine blood work, background baseline diet). During
      Visits 2, 3 and 4, at 3 time points (pre-ingestion, 60 and 120 minutes post ingestion),
      participants will complete subjective baseline testing including questionnaires that assess
      mental clarity, mood, focus, concentration, productivity, anxiety/stress, and the Happiness
      Scale in addition to completing a series of objective neuropsychological tests (e.g.,
      Go/no-go test, N-back test, Serial Sevens test) to assess cognitive performance. Safety will
      be monitored via vital signs (heart rate, blood pressure) and adverse events (AE) throughout
      study.
    

Intervention name(s): Placebo; AmaTea Guayusa Extract; Lion's Mane
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 650 mg of placebo, given as two capsules containing maltodextrin; 650 mg of AmaTea Guayusa Extract, given as two capsules; 1000 mg of Lion's Mane, given as two capsules
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
International Psychometric Validation Study of the Intestinal Gas Questionnaire (IGQ)
Condition: IBS - Irritable Bowel Syndrome; General Population
MeSH terms: Irritable Bowel Syndrome
Study type: Observational

Summary: 
      Objective: To confirm the psychometrics properties of the Intestinal Gas Questionnaire (IGQ)
      in subjects with Irritable Bowel Syndrome (IBS) diagnosis and General population both
      complaining of Gas-Related Symptoms (GRS).

      IGQ has been developed previously simultaneously in UK English, French and Spanish through
      qualitative research with subject interviews. The conceptual framework of the IGQ assesses
      both GRS and their impact on daily life. Similar concepts were identified for both subjects
      with IBS diagnosis and general population and complaining of gas-related symptoms.

      The IGQ consists of a 24-hour recall symptom diary assessing 7 gas-related symptoms (17
      items) and a 7-day recall questionnaire which assesses the impact of those symptoms (26
      items)
    

Detailed description: 
      Observational (non-interventional) study with a cross-sectional part for a subset of adult
      subjects with a single IGQ completion and a longitudinal cross-over part for a subset of
      subjects with test-retest IGQ completion for validation of electronic version of IGQ.

      300 eligible subjects (100 in each of the 3 countries: France, UK & Spain):

        -  180 with IBS diagnosis (60% of recruited subjects)

        -  120 from General population (40% of recruited subjects)
    

Intervention name(s): completion of self-reported questionnaires
Intervention type(s): Other
Intervention description(s): Single completion: Participants will have to complete the IGQ, the generic health status EQ-5D questionnaire, the specific FDDQL questionnaire (Functional Digestive Disorders Quality of Life).
Test-retest: during the second completion within a mean 7-day interval, participants will complete the IGQ and a single global Gastro-Intestinal Well-Being scale
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        IBS patients and subjects from general population complaining of Gas-Related Symptoms (GRS)
      
Keywords: IBS, population
Topical Anesthesia / Bronchoscopy
Condition: Equally of Delivery Systems of Local Anesthesia in Bronchoscopy
Study type: Observational

Summary: 
      The primary aim of this study is to compare a simplified single-use product (LMA® MAD Nasal™
      Intranasal Mucosal Atomization Device, Teleflex medical, Kernen Germany) for topical
      nasopharyngeal anesthesia in comparison to a multi-use device (Laryngeal atomizer, Karl
      Storz, Tuttlingen, Germany in terms of patient self-rated nasopharyngeal symptoms.
    

Detailed description: 
      Patients included in the first half of the study (topical anesthesia with the Laryngeal
      atomizer) and with need for another bronchoscopy in the second half of the study (topical
      anesthesia with the Intranasal Mucosal Atomization Device) will be asked to repeat the
      questionnaire after the second bronchoscopy to allow in-patient comparison.

      Description of the primary efficacy analysis and population:

      The primary endpoint of patient self-rated anesthesia by visual analogue scale after topical
      nasopharyngeal anesthesia for bronchoscopy.
    

Intervention name(s): topical anesthesia multi-use device; topical anesthesia Intranasal Mucosal Atomization
Intervention type(s): Device; Device
Other intervention name(s): anesthesia with multi-use device (Laryngeal atomizer, Karl Storz, Tuttlingen, Germany; single-use product (LMA® MAD Nasal™ Intranasal Mucosal Atomization Device, Teleflex medical, Kernen Germany) for topical anesthesia
Intervention MeSH terms: Anesthetics
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients after lung transplantation
      
Keywords: anesthesia; bronchosocopy; lung transplantation
Nutrition Study for School Age Children
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      In this study, we evaluate whether dietary advice based on two healthy nutritional programs
      can be effectively delivered to families over one month by telephone. We hypothesize that
      among overweight school age children, a one-month telephone intervention will result in
      specific dietary changes consistent with the randomly assigned dietary intervention.
    

Detailed description: 
      Overweight and obesity have increasingly become problems faced by children. However, the best
      dietary approach for managing weight in children remains unclear and how to make dietary
      advice practical remains a challenge. The primary aim of the study is to evaluate the
      feasibility of a one-month telephone-based dietary intervention for pediatric obesity in
      achieving changes in the target variable (dietary glycemic load or dietary fat) of the
      assigned intervention. We hypothesis that among overweight school age children, a one-month
      telephone intervention will elicit specific dietary changes consistent with the randomly
      assigned prescriptions. Specifically, children counseled to reduce glycemic load will achieve
      a significantly greater mean reduction in glycemic load than those counseled to reduced
      dietary fat and, conversely, those counseled to reduce dietary fat will achieve a
      significantly greater mean reduction in dietary fat than those counseled to reduce glycemic
      load. The first ten participants enrolled will comprise a pilot study group intend to inform
      study design/methods and will not be included in the primary analysis.
    

Intervention name(s): 1; 2
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Low glycemic load diet by telephone counseling; Low fat diet by telephone counseling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effects and Tolerability With Clenpiq and Low Residue Diet
Condition: Colonoscopy Preparation
Study type: Interventional

Summary: 
      The Efficacy of Clenpiq utilized per FDA labeling, with a low residue diet the day before
      colonoscopy.
    

Detailed description: 
      This study proposes to assess the use of a low residue diet of a prescribed nature the day
      before colonoscopy for breakfast, lunch and early dinner. Clinical outcomes utilizing the low
      residue diet will be compared to the Food and Drug Administration (FDA) approved split dose
      labeling, including the traditional clear liquid diet the day before colonoscopy utilizing
      the Clenpiq (Ferring Pharmaceuticals) bowel preparation.
    

Intervention name(s): Low Residue Diet
Intervention type(s): Other
Intervention description(s): Variable cohort will eat 3 low residue meals on the day prior to their planned colonoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: single blind trial of FDA approved preparation with per labeling clear liquid diet versus a single day low residue diet
Masking: Single (Investigator)
Primary purpose: Other
Keywords: low residue diet