bioihbjkbjnl/mcl2 huggingface dataset:
Virtual Reality to Reduce Labor Pain
Condition: Labor Pain; Virtual Reality; Hypnosis
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      Background and Goal of Study Labor pain remains an area where different analgesia options are
      looked for, more specifically non-pharmacological remedies are popular. Hypnosis and virtual
      reality (VR) have been studied with encouraging results. However, until now, the combination
      of VR and hypnosis (VRH) has not been assessed during labor, although it has shown promising
      results in other acute pain areas. The VRH4L study will evaluate the efficacy of Virtual
      Reality Hypnosis (VRH) in reducing pain during labor. Hypnosis is delivered as a standardized
      therapeutic intervention through virtual reality, using a digital sedation software (AQUA ®,
      Oncomfort SA).

      For this prospective, interventional parallel group, monocentric randomized controlled trial
      full term women who were planned for an induction of labor at the St-Jean Hospital in
      Brussels from March to May 2021 were included. Women with complicated pregnancies and
      patients with contraindications to VR were excluded.

      Patients were randomized in two arms. In the VRH group the patients received a 30-minute
      session of virtual reality hypnosis when in active labor and had access to standard care.
      Patients in the control group received only standard care.

      Primary outcome was the difference in post intervention pain score between the two arms.
      Secondary outcomes were the difference in pain score 30 minutes after the intervention, vital
      signs correlated to pain, satisfaction of the experience, interaction with the midwife and
      prevalence of side effects. Data was analyzed using the student's T test.
    


Intervention name(s): VRH (Virtual Reality Hypnosis); Standard care
Intervention type(s): Device; Behavioral
Intervention description(s): Hypnosis is delivered as a standardized therapeutic intervention through virtual reality, using a digital sedation software (AQUA ®, Onfomfort SA).; The standard treatment (ST) for labor pain as used in our hospital contains massage, aquatherapy and postural exercises. This is always available for any woman in labor.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective interventional Randomized Controlled Trial
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: non-pharmacological analgesia
Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for MS (CLASSIC-MS)
Condition: Multiple Sclerosis (MS)
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study was to collect data both retrospectively and prospectively in
      order to evaluate the long-term outcomes, durability of effect, and real-world treatment
      patterns following treatment with Cladribine Tablets or placebo in participants with multiple
      sclerosis (MS) who were previously participated in the parent studies (ORACLE MS and
      CLARITY/CLARITY-EXT).
    


Intervention name(s): Data Collection
Intervention type(s): Other
Intervention description(s): No study treatment was administered as part of this study
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Multiple Sclerosis; Cladribine; High Disease Activity
Respiratory Outcome of Children From the FEPED Cohort
Condition: Asthma in Children
Study type: Observational

Summary: 
      Early lung function deficits represent a significant risk factor for the evolution toward
      chronic obstructive pulmonary disease later in life. Prematurity and in utero tobacco smoke
      exposure are already known to predispose children to develop a non-reversible obstructive
      ventilatory defect in adulthood. The role of vitamin D status during pregnancy is less
      certain. In humans, low vitamin D concentrations during pregnancy are associated to an
      increased risk of asthma in children. In murine models, low vitamin D concentrations during
      pregnancy are associated to structural abnormalities of the airways in mouse pups.
      Investigators hypothesized that vitamin D play a role in early airways development, from the
      first trimester of pregnancy. To bring arguments to this hypothesis, the investigators will
      study the association of airway resistance in children aged 5 to 6 years old with the
      concentration of vitamin D during the first trimester of pregnancy in their mothers.
    

Detailed description: 
      Children aged 5 to 6 years old will be included from the FEPED cohort. The FEPED cohort is a
      cohort of French pregnant women designed to study the association between vitamin D status
      during pregnancy and the risk of pre-eclampsia. Vitamin D concentration at first and third
      trimester of pregnancy as well as in cord blood is available for 1400 women. Investigators
      will include 200 children born from these women. Children will undergo lung function tests
      and prick-tests and parents will answer the ISAAC questionnaire that is a standardised
      questionnaire designed to evaluate asthma and rhinitis symptoms. The main outcome of this
      study will be specific airway resistance. The investigators will look for an association
      between specific airway resistance and vitamin D concentration measured during the first
      trimester of pregnancy in their mothers.
    

Intervention name(s): Plethysmography
Intervention type(s): Other
Intervention description(s): Lung plethysmography
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        term-born child (gestational age ≥ 37 weeks of post-menstrual age) whose mother was
        included in the FEPED cohort, with measure of vitamin D concentration available at the
        first and third trimester of pregnancy and in cord blood
      
Keywords: Lung function; Children; Vitamin D; COPD
A Study of the Safety and Immune Response of 2 Doses of a New Shigella Vaccine in Kenyan Adults
Condition: Shigella Sonnei Infection
MeSH terms: Dysentery, Bacillary
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and the immunogenicity of two different
      doses of the GVGH S. sonnei vaccine in healthy adults and represents the first step towards
      testing of the GMMA vaccine in the vaccine target population of children from developing
      countries where shigellosis is endemic.
    


Intervention name(s): GVGH S. sonnei (1790GAHB) vaccine 25 μg; GVGH S. sonnei (1790GAHB) vaccine 100 μg; Menveo; Boostrix
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Two injections of the study vaccine were administered 28 days apart.; Two injections of the study vaccine were administered 28 days apart.; One injection of Menveo was administered in subjects in the Control Group.; One injection of Boostrix was administered in subjects in the Control Group.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study of HY209 in Healthy Male Volunteers for Sepsis
Condition: Sepsis
MeSH terms: Sepsis
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, double-blind, placebo-controlled single dosing, dose escalation phase I
      clinical trial to investigate the safety/tolerability and pharmacokinetics of HY209 after
      intravenous administration in healthy male volunteers
    

Detailed description: 
      HY209, which is being developed for the treatment of sepsis, inhibits inflammation by
      promoting the differentiation and division of Myeloid-derived suppressor cells (MDSCs).
    

Intervention name(s): HY209
Intervention type(s): Drug
Intervention description(s): 6 Subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.
Other intervention name(s): HY209-IV
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled single dosing, dose escalation
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Neoadjuvant Chemo-endocrine Therapy Versus Chemotherapy Alone in ER-positive, HER2-negative Breast Cancer
Condition: Breast Cancer Female
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This was an open-label, randomized controlled trial that aims to compare the efficacy and
      safety of the concurrent neoadjuvant chemotherapy with endocrine therapy and neoadjuvant
      chemotherapy alone in ER-positive, HER2-negative breast cancer.
    

Detailed description: 
      Data showed that concurrent neoadjuvant chemotherapy with endocrine therapy was a effective
      option for ER-positive, HER2-negative breast cancer patients. However this is still a
      controversial issue. The present study is an open-label randomized controlled clinical trial
      that aims to investigate the efficacy of concurrent NCT with endocrine therapy (AI with or
      without GnRH-a) in patients with ER-positive, HER2-negative breast carcinoma.
    

Intervention name(s): letrozole, leuprorelin, fluorouracil, epirubicin, cyclophosphamide, docetaxel; fluorouracil, epirubicin, cyclophosphamide, docetaxel
Intervention type(s): Drug; Drug
Intervention description(s): Postmenopausal patients were treated with letrozole 2.5mg/day p.o until complement of neoadjuvant chemotherapy before surgery, while premenopausal ones received letrozole 2.5mg/day p.o and a subcutaneous injection of the GnRH-a, leuprorelin, as concomitant treatment with neoadjuvant chemotherapy (fluorouracil 600mg/m2 IV, epirubicin 90mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles followed by docetaxel 100mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles; or epirubicin 90mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles, followed by docetaxel 80mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles), letrozole was delivered after 1 week of first dose of leuprorelin injection.; Patients received fluorouracil 500mg/m2 IV, epirubicin 90mg/m2 IV and cyclophosphamide 500mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles followed by docetaxel 100mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles; or epirubicin 90mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles, followed by docetaxel 100mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles.
Other intervention name(s): GnRH-a, ENANTONE
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Fluorouracil; Letrozole; Epirubicin; Leuprolide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breast cancer; neoadjuvant chemotherapy; endocrine therapy; concurrent
B-cell Immunity to Influenza (SLVP017)- Year 1, 2009
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an exploratory study using a strategy that has not been previously employed to
      investigate the effects of age and vaccine type on specific kinds of immune responses to
      licensed, seasonal 2009-2010 influenza vaccines in children and adults.
    

Detailed description: 
      This study is being conducted in healthy male and female volunteers. 8-17 year-old identical
      twins will be randomly assigned to receive a single administration of the 2009-2010
      formulation of either seasonal trivalent inactivated influenza vaccine (TIV) or live,
      attenuated influenza vaccine (LAIV). Twins within a pair will receive different vaccines.
      18-30 year-old and 70-100 year-old subjects will receive a single administration of the
      2009-2010 formulation of TIV. Blood samples to conduct the assays will be taken at
      pre-immunization, Day 7-8 and Day 28 post immunization.
    

Intervention name(s): Fluzone® 2009-2010 Formula; FluMist® 2009-2010 Formula
Intervention type(s): Biological; Biological
Intervention description(s): This vaccine is given intramuscularly; This vaccine is given intranasally
Other intervention name(s): Trivalent inactivated influenza vaccine (TIV); FDA-licensed seasonal influenza vaccine; Live, attenuated influenza vaccine (LAIV); FDA-licensed seasonal influenza vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Inactivated influenza vaccine; Live, attenuated influenza vaccine; Child identical twins; Young and elderly adults
Study to Assess the Bioavailability, Pharmacokinetics, Safety, and Tolerability of AVP-923 in Healthy Adult Participants
Condition: Healthy Adult Male and Female Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted to evaluate the relative bioavailability, pharmacokinetics,
      safety, and tolerability of AVP-923 (dextromethorphan hydrobromide [DM] and quinidine sulfate
      [Q] capsules) when the contents of a capsule are administered in applesauce or via a
      nasogastric feeding tube, compared with administration of a capsule in healthy, fasting,
      adult participants.
    

Detailed description: 
      This is an open-label, single-center, randomized, single-dose, 3-treatment, 3-period,
      6-sequence crossover study in healthy adult participants consisting of approximately 7 weeks
      of treatment. The study population will be limited to extensive metabolizers of cytochrome
      P450 (CYP) 2D6.

      Approximately 18 participants will be randomly assigned to 1 of 6 sequences (ABC, ACB, BAC,
      BCA, CAB, CBA).
    

Intervention name(s): AVP-923
Intervention type(s): Drug
Intervention description(s): capsule
Other intervention name(s): Dextromethorphan Hydrobromide and Quinidine Sulfate
Intervention MeSH terms: Quinidine; Dextromethorphan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bioavailability; pharmacokinetics; safety; tolerability; AVP-923; dextromethorphan; quinidine
SNAGs in Mechanical Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Neck pain is second largest cause of disability worldwide. Chronic neck pain prevalence is
      14% which is somewhat higher in females as compared to males. In India reported prevalence is
      6%. Therapeutically, neck pain is managed by physiotherapists using rest, stretching and
      strengthening exercises, educating patient, and intense proprioception and positional
      exercises.
    

Detailed description: 
      To determine the evidences for the efficacy of SNAGs in the Management of Mechanical Neck
      Pain.

      100 patients [Age group 25-45 yrs] who were diagnosed with neck pain, with onset ˃1-3 months
      (chronic) were randomly assigned to group A receiving conventional Physiotherapy plus SNAGs
      and group B receiving conventional Physiotherapy plus ultrasound.

      Subjects in-group A that received conventional Physiotherapy plus SNAGs showed greater
      Improvement in pain and range of motion compared with the conventional Physiotherapy plus
      ultrasound group on 2nd week compared with pretreatment.

      The result of study suggests that both SNAGs and Ultrasound groups improves the symptoms of
      neck pain. Ultrasound group improved the pain symptoms but was too small to reach
      satisfactory outcome for patients. Based on these results conventional Physiotherapy plus
      SNAGs should be the treatment of choice for neck pain rather than conventional Physiotherapy
      plus Ultrasound .
    

Intervention name(s): Ultrasound Therapy, SNAGs
Intervention type(s): Other
Other intervention name(s): Hot Pack, Exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants randomly assigned to group A receiving conventional Physiotherapy plus SNAGs and group B receiving conventional Physiotherapy plus ultrasound.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Therapeutic Strategies in Sexual Function
Condition: Male Sexual Dysfunction; Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Observational

Summary: 
      Objectives: To know the main therapeutic strategies used by men with spinal cord injury in
      sexual dysfunctions.
    

Detailed description: 
      Methods: This is a descriptive observational study involving 24 men with a mean age of 32.62
      (CI 28.65 to 36.60), with spinal cord injury, recruited in reference services in spinal cord
      injury Recife (PE). The subjects underwent neurological evaluation in accordance with the
      guidelines of the International Standards for Neurological Examination and Functional
      classification of Spinal Cord Injury (ISNCSCI), the American Spinal Injury Association
      (ASIA), assessment of sexual function through the Erectile Function of International Index
      (IIEF) and answered a semi-structured form to identify therapeutic strategies used in sexual
      function. To collect information about medicinal plants, a search was made in the
      surroundings of public markets located in the Metropolitan Region of Recife (PE).
    

Intervention name(s): Therapeutic Strategies
Intervention type(s): Other
Intervention description(s): Using questionnaires (Erectile Function of International Index and American Impairment Scale) and search in public markets using semi structured form
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study involving 24 men with spinal cord injury, recruited in reference services in
        spinal cord injury Recife (PE). Aged between 18 and 60 years with a clinical diagnosis of
        traumatic spinal cord injury, injury time less than six months, heterosexual and sexually
        active. The study excluded patients who had erectile dysfunction attributed to endocrine or
        metabolic disease order, those who underwent surgery in the genital area, such as radical
        prostatectomy or penile implant and cognitive impairment.
      
Keywords: Sexuality; Spinal cord injuries; Complementary Therapies; Medicinal plants
Intravenous Lignocaine vs Placebo
Condition: Hemodynamic Stability Post Intubation in Laryngoscopy Surgery
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the mean hemodynamic responses post-intubation in patients given intravenous
      lignocaine pre-intubation as compared to a placebo pre-intubation in patients undergoing
      laryngoscopy surgery
    

Detailed description: 
      After identifying the candidate, details will be carefully discussed with the subject. The
      subject (or, when necessary, the parent or legal guardian if the subject is younger than 18
      years of age or under guardianship) will be read the approved protocol consent form. Patients
      who have given informed consent to participate in the study will be randomized into one of
      the two study arms one day before the procedure. The study team present will open the sealed
      envelopes provided by the Indus Hospital Research Center's Clinical Research Unit (CRU) that
      provides the study arm allocation. The envelopes will follow the SNOSE protocol.
    

Intervention name(s): iv Lignocaine vs placebo
Intervention type(s): Drug
Intervention description(s): Lignocaine is available in an ampule of 10 ml containing 20 mg/ml of lignocaine or 2%, Lignocaine will be given in dose of 1.5 mg/kg I/V
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Equal allocation
Masking: None (Open Label)
Primary purpose: Prevention
Gastrectomy, Eating Behaviour and GLP-1
Condition: Gastric Cancer; Dumping Syndrome
MeSH terms: Dumping Syndrome
Study type: Interventional

Summary: 
      Patients who have undergone gastrectomy (removal of the stomach) to treat or prevent cancer
      are known to have a significantly reduced quality of life. To date, there is very little
      information on the physiological causes of this. The investigators suspect that
      overproduction of a hormone (chemical) called glucagon like peptide-1 (GLP-1) released by the
      lining of the gut may play a role in the reduced appetite, weight loss and low blood sugar
      symptoms seen in this group. To investigate this, the investigators will study the response
      of 16 patients who have previously had a gastrectomy to a glucose drink, and a meal, while
      receiving an infusion of a specific blocker of GLP-1 or placebo. The investigators will
      examine the levels of sugar and associated hormones in the blood, food consumption and food
      reward behaviour using standard tools.

      Participants will be invited to attend the Clinical Research Facility at Addenbrooke's
      Hospital for a screening visit, and two whole day study visits. The study has been designed
      to assess the role of overproduction of GLP-1 by completely blocking its actions, rather than
      assess the use of the blocking compound as a medication, and is therefore regarded as a
      physiological study, not a clinical trial.

      The goal of this study is to demonstrate the magnitude of effect of GLP-1 on blood sugar and
      appetite derangement in patients who have had a gastrectomy. This will guide future work on
      the development of novel treatment paradigms for the post-gastrectomy patient group.
    


Intervention name(s): Exendin 9-39; Placebo
Intervention type(s): Other; Other
Intervention description(s): Complete blockade of action of endogenous GLP-1 by Exendin 9-39. Defined as a physiological study, not a clinical trial as such (as advised by the UK MHRA).; Infusion of 1% human albumin in normal saline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Dumping syndrome; Gastrectomy; GLP-1; Insulin
Effects of Negative Energy Balance on Muscle Mass Regulation
Condition: Weight Loss; Obesity; Skeletal Muscle; Insulin Sensitivity/Resistance
MeSH terms: Insulin Resistance; Weight Loss
Study type: Interventional

Summary: 
      The investigators here propose to perform a prospective randomized intervention trial in
      post-menopausal women to investigate the endocrine network, which contributes to the changes
      in skeletal muscle mass during weight loss.
    


Intervention name(s): multimodal lifestyle intervention; placebo
Intervention type(s): Behavioral; Behavioral
Intervention description(s): multimodal lifestyle intervention will be performed to reduce body weight; no intervention, only follow up
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: weight loss; muscle mass