bioihbjkbjnl/mcl2 huggingface dataset:
Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2
Condition: Intraventricular Haemorrhage Neonatal; Death; Neonatal
MeSH terms: Premature Birth; Hemorrhage
Study type: Interventional

Summary: 
      This study is being done to find out whether umbilical cord milking (UCM) is at least as good
      as or better than delayed cord clamping (DCC) to reduce bleeding in the brain or prevent
      death in premature newborns. The investigators will study short and long term outcomes of
      infants delivered before 32 weeks gestation that receive either UCM or DCC.

      * The trial was stopped by the DSMB for safety in the small strata. They subsequently allowed
      for continuation of the trial in infants 29-32+6 wk GA.
    

Detailed description: 
      Aim 1. Compare the incidence of severe intraventricular hemorrhage (IVH) and/or death in
      premature newborns <33 weeks gestational age (GA) delivered by C/S receiving UCM to those
      receiving DCC.

      Hypothesis1: First demonstrate infants in the UCM group are not inferior to the DCC group
      (reject H10).

      Hypothesis2: If H1 is true, demonstrate lower incidence of severe IVH and/or death in UCM
      infants compared to DCC.

      Aim 2. Compare the safety and efficacy profiles of premature newborns <33 weeks GA delivered
      by C/S receiving UCM vs. DCC during their hospitalization.

      Hypothesis3: UCM group will have a decreased need for resuscitation interventions with no
      differences in bilirubin or polycythemia compared to DCC.

      Hypothesis4: UCM group will have improved blood pressures in the first 24 hours of life
      compared to DCC.

      Aim 3 (exploratory). To compare the outcomes of premature newborns <33 weeks GA delivered by
      C/S (Cesarean section) (from Aims 1 and 2) with those born by V/D (vaginal delivery)
      receiving UCM or DCC.
    

Intervention name(s): Umbilical cord milking UCM; Delayed cord clamping DCC
Intervention type(s): Procedure; Procedure
Intervention description(s): At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before it is clamped. This procedure infuses a placental transfusion of blood into the preterm neonate and can be done in 15-20 seconds.; At delivery, delayed cord clamping will be performed by having the delivering obstetrician delay clamping of the umbilical cord for at least 60 seconds.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Premature infants; Umbilical cord milking; Delayed cord clamping; Intraventricular Hemorrhage; Death
A Study to Evaluate How Well Single and Multiple Doses of GLPG3667 Are Tolerated in Healthy, Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a phase I, randomized, double-blind, placebo-controlled, single-center, to
      evaluate the safety, tolerability, and pharmacokinetics (PK) of GLPG3667 after an oral single
      dose (SD) of GLPG3667 (part 1) and after oral multiple doses (MD) for 13 days of GLPG3667
      (part 2) in healthy male subjects.
    


Intervention name(s): GLPG3667; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GLPG3667 capsules; Matching placebo capsules
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Comparing Health Services Interventions for the Prevention of HPV-related Cancer
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      The study aims to identify global and local determinants of HPV vaccine acceptability, HPV
      vaccine uptake and compliance as well as identify logistics and programmatic issues in each
      country to offer the HPV vaccine, as a potential cervical cancer prevention strategy, to
      mid-aged women attending screening.
    

Detailed description: 
      3000 women aged within the age range of 25-45 years old will be recruited; 250-300 women per
      country. These women will be identified by means of screening registry lists or screening
      clinical visits. Eligible women will receive a study questionnaire on the HPV vaccine.
      Additionally, and independently of participating in the study questionnaire, those who accept
      will get 3 HPV vaccine doses. Depending on country preferences, either Cervarix®
      (Glaxosmithkline Biologicals, S.A.) at month 0, 1 and 6 or Gardasil® (Sanofi Pasteur MSD SNC)
      at month 0, 2 and 6, will be administered.

      Safety data and HPV vaccine compliance will be assessed.

      A sub study in Spain will also analyze acceptability of HPV vaccination in a sample of women
      aged 35-40 yrs identified as poor screening attenders.

      Two independent informed consent forms will be provided; one for the study questionnaire
      participation and another for HPV vaccine administration.
    

Intervention name(s): questionnaire; Gardasil vaccine; Cervarix®
Intervention type(s): Other; Biological; Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Sit-to-stand Test in Cystic Fibrosis Children and Adolescents
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      Cystic fibrosis (CF) is a chronic hereditary respiratory disease. Exercise testing is part of
      CF patients regular assessment.

      Cardio-Pulmonary Exercise Testing (CPET) is currently considered as the gold standard to
      assess physical capacities. However, simple field tests are emerging. These tests are easier
      to perform especially in a population of CF children and adolescents.

      The 1minute Sit-To-Stand test have recently been evaluated in CF adults. This test correlates
      with maximal oxygen consumption during CPET.

      The investigators hypothesized that this test also correlates with 6-Minute Walking distance
      (during a 6-min Walk Test), quadriceps strength, respiratory muscles strength and
      health-related quality of life.
    


Intervention name(s): Sit-to-stand test; 6-Minute Walk Test
Intervention type(s): Behavioral; Behavioral
Intervention description(s): CF young patients will perform 2 STS tests. Number of repetitions, cardio-respiratory response and physiological adaptations during the second test will be monitored.; CF young patients will perform 2 6MWT tests. Number of repetitions, cardio-respiratory response and physiological adaptations during the second test will be monitored.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Cystic Fibrosis; Exercise Testing; Muscular strength; Pediatrics; Quality of life
Urodynamic Evaluation in Patients With Anorectal Malformation According to Spinal Cord Abnormalities
Condition: Anorectal Malformation
MeSH terms: Anorectal Malformations; Congenital Abnormalities
Study type: Observational

Summary: 
      This study will examine the effects of spinal cord abnormalities on perioperative
      neurovesical dysfunction in patients with anorectal abnormalities.
    


Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients with anorectal malformation
      
Keywords: patients with anorectal malformation
Intra-operative Optical Imaging With MDX1201-A488 in Patients With Prostate Cancer
Condition: Adenocarcinoma of the Prostate; Stage IIB Prostate Cancer; Stage III Prostate Cancer; Stage IV Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This pilot clinical trial studies the best dose of anti-prostate specific membrane antigen
      (PSMA) monoclonal antibody MDX1201-A488 (MDX1201-A488) given before surgery to aid in
      visualization of the prostate. Attaching a fluorescence, a substance that emits radiation
      that is visible, to the anti-PMSA antibody and injecting it into the body may help identify
      the tumor when specialized microscopes are used.
    

Detailed description: 
      PRIMARY OBJECTIVES: I. Determine the preferred imaging dose (if any), based on image quality
      and correlation with pathological findings, of intravenously administered MDX1201-A488 in a
      dose-escalating study (doses of 5 and 15 mg) in patients with moderate to high-risk prostate
      cancer prior to undergoing robotic assisted laparoscopic prostatectomy (RALP), subject to
      predetermined safety stopping rules.

      SECONDARY OBJECTIVES: I. Correlate intra-operative optical imaging (IOOI) findings with
      pre-operative magnetic resonance imaging (MRI) findings and clinical staging.

      OUTLINE: This is a dose-escalation study. Patients receive anti-PSMA monoclonal antibody
      MDX1201-A488 intravenously (IV) over 30 minutes on day 1 and undergo IOOI during RALP on day
      5.

      After completion of study treatment, patients are followed up at 4-7 weeks, 3 months, 6
      months, 9 months, and 1 year.
    

Intervention name(s): anti-PSMA monoclonal antibody MDX1201-A488; robot-assisted laparoscopic surgery; diffuse optical imaging; pharmacological study; Laboratory Biomarker; Questionnaire
Intervention type(s): Biological; Procedure; Other; Other; Other; Other
Intervention description(s): Given IV; Undergo RALP; Undergo IOOI; Correlative studies; Correlative studies; Ancillary studies
Other intervention name(s): MDX1201; MDX1201-A488; diffuse optical spectroscopy; diffuse optical tomography; DOI; near infrared optical tomography; pharmacological studies
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Study of LY3437943 in Participants With Type 2 Diabetes Mellitus (T2DM)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to learn about the side effects of LY3437943 when given to
      participants with type 2 diabetes. Blood tests will be performed to investigate how the body
      processes the study drug and how the study drug affects the body. Each enrolled participant
      will receive injections of LY3437943, dulaglutide, or placebo given just under the skin. For
      each participant, the study will last up to about 5 months and will include 16 visits to the
      study center.
    


Intervention name(s): LY3437943; Dulaglutide; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered SC; Administered SC; Administered SC
Other intervention name(s): LY2189265
Intervention MeSH terms: Dulaglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Study to Assess the Safety and Efficacy of Multiple Doses of VB-201 on Biomarkers
Condition: Biomarker
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and tolerability of multiple doses of
      VB-201 administered for 4 weeks and its efficacy on biomarkers.
    


Intervention name(s): VB-201 or Placebo
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Clinical Evaluation of the Storz CMAC Laryngoscope
Condition: Intubation; Airway Management
Study type: Interventional

Summary: 
      This study aims to evaluate the utility of a video assisted device for intubation (placement
      of a breathing tube) during surgery. This study specifically aims to compare a video assisted
      intubation with the CMAC laryngoscope to conventional devices in the setting of intubations
      predicted to be difficult.
    

Detailed description: 
      Patients will be specifically screened for predictors by history and physical exam of
      potential airway difficulty. The role of video laryngoscopy in airways predicted to be
      difficult is poorly defined. This study aims to recognize if video laryngoscopy is more
      useful than conventional laryngoscopy as a first attempt for those with anticipated
      difficulty.
    

Intervention name(s): CMAC video laryngoscope; Macintosh laryngoscope
Intervention type(s): Device; Device
Intervention description(s): Intubation utilizing the assistance of video enhancement; Patients will be intubated utilizing either a Macintosh 3 or Macintosh 4 designed blade
Other intervention name(s): CMAC; Storz laryngoscope; Mac blade
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Video laryngoscopy; Intubation success; Difficult airway; CMAC laryngoscope
A Multicenter Study to Evaluate the ROX Anastomotic Coupler System (ACS) In Patients With Severe Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and performance of the ROX Anastomotic
      Coupler System (ACS) in patients with severe hypertension.
    


Intervention name(s): ROX ANASTOMOTIC COUPLER SYSTEM (ACS); ROX Anastomotic Coupler System (ACS)
Intervention type(s): Device; Device
Intervention description(s): The ROX Anastomic Coupler (ACS) will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: High Blood Pressure; Hypertension; Resistant Hypertension
Follow-up of Glypressin (Terlipressin) Clinical Efficacy in the Treatment of Bleeding Oesophageal Varices
Condition: Gastrointestinal Bleeding; Oesophageal Varices
MeSH terms: Gastrointestinal Hemorrhage; Esophageal and Gastric Varices; Varicose Veins; Hemorrhage
Study type: Observational

Summary: 
      Terlipressin is an effective and safe treatment for bleeding caused by rupture of oesophageal
      varices, which are life-threatening complications of liver cirrhosis.

      Oesophageal varices are abnormal dilatation of veins occurring in the lower oesophagus, which
      can develop in patients with cirrhosis. Bleeding caused by rupture of these varices is a
      life-threatening complication with mortality between 20-50%.

      Such bleeding can be treated with drug therapy and/or endoscopic; endoscopic therapy consists
      of a flexible tube equipped with a camera at the terminal end, allowing for visualizing and
      treating the oesophageal varices.

      In this study, investigators will evaluate the safety and efficacy of terlipressin -
      Glypressin 1 mg, powder and solvent for solution for injection.

      The non-interventional observational study "Follow-up of Glypressin (terlipressin) clinical
      efficacy in the treatment of bleeding oesophageal varices" aims to demonstrate that
      administration of Glypressin (terlipressin 1 mg) controls the bleeding in such patients.
    


Intervention name(s): Glypressin (terlipressin)
Intervention type(s): Other
Intervention description(s): Study drug (without placebo)
Intervention MeSH terms: Terlipressin
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        60 estimated eligible participants with an age of 18-70 years, suspected or diagnosed with
        bleeding oesophageal varices. Patients have cirrhosis (from any cause, any Child class) and
        upper gastrointestinal haemorrhage
Prevalence of Erupted Supernumerary Teeth Among a Group of Egyptian Children Aged From Six to Fifteen Years Old
Condition: Supernumerary Teeth
MeSH terms: Tooth, Supernumerary
Study type: Observational

Summary: 
      The purpose of this study is to assess the prevalence of erupted supernumerary teeth among a
      group of Egyptian children aged from 6-15 years old attending the Outpatients' clinic of
      Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo
      University.
    

Detailed description: 
      -  Clinical examination will be done for participants fulfilling the inclusion criteria
           after obtaining an informed consent from parents for acceptance of participation in the
           study after explaining the purpose of the study and the measures that will be held to
           the child.

        -  A custom made examination chart (Appendix 1) will be filled out, during face to face
           interview with the child and/or his parents, including: date, name, age, gender,
           address, medical history and previous dental treatment followed by clinical examination
           to detect the presence of supernumerary teeth.

        -  The presence of supernumerary teeth and its type and location will be recorded in the
           examination chart.

        -  Each child with supernumerary teeth will be given a letter, translated into Arabic,
           outlining his dental status to inform the parents about the condition and the need for
           treatment

      Examination chart (Appendix 1 ):

      Date :...................................................................

      Personal information:

      Name.............................................
      Age..........................................

      Gender :.......................................... Address : ................................

      Phone number : .................................................. Medical history:
      .........................................................
      ..................................................................................

      Previous dental history: ...........................................

      ......................................................................................

      Clinical examination :

      Supernumerary teeth: presence / absence Location :
      ........................................... Type
      :..................................................
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants will be selected from the Outpatients' clinic of Pediatric Dentistry and
        Dental Public Health Department, Faculty of Dentistry, Cairo University according to the
        eligibility criteria.
      
Keywords: supernumerary tooth; hyperdontia; mesiodens; paramolar
Manual Therapy Versus Conventional Rehabilitation Protocol on Subacromial Pain Syndrome
Condition: Subacromial Impingement Syndrome
MeSH terms: Shoulder Impingement Syndrome; Syndrome
Study type: Interventional

Summary: 
      This study compares the periodic effects of Accelerated rehabilitation protocol (ARP) and
      Mulligan mobilization with mowement method (MWM) in subacromial pain syndrome patients
      rehabilitation. Half of the participants will receive ARP, while the other half will receive
      MWM.
    


Intervention name(s): accelerated protocol and mulligan method
Intervention type(s): Other
Intervention description(s): manual therapy technic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: shoulder pain
Water Intervention for Thinking in Kids (WITiKids ) Study
Condition: Low Fluid Intake, Chronic
Study type: Interventional

Summary: 
      The aim of this study is to determine the influence of changes in water intake on changes in
      cognitive function among preadolescent children. Further, the proposed work will determine
      the relationship between urinary markers of hydration process and cognitive function. We
      hypothesize that an increase in water intake will result in greater cognitive performance. In
      addition, improvements in hydration demonstrated by lower urine concentration will be
      correlated with greater cognitive performance.
    


Intervention name(s): Water Intake
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Water; Children; Cognition; Hydration
ESM-derived Personalised Feedback for Women at Risk of Common Mental Disorder
Condition: Women at Risk of Common Mental Disorders
MeSH terms: Mental Disorders; Psychotic Disorders
Study type: Interventional

Summary: 
      This study aims to examine the effectiveness of Experience Sampling Method (ESM) derived
      personalised feedback for women at risk of common mental disorder in Hong Kong, in reducing
      individuals depressive and anxiety symptoms.
    

Detailed description: 
      Women who are at-risk for common mental disorders and have completed the online screening for
      Jockey Club Mental Wellness Project for Women (JCWow) will be recruited. This study aims to
      test the effectiveness of ESM-derived personalized feedback in reducing symptoms of
      depression and anxiety using a randomised controlled trial. After given written consent, the
      participants will be required to undergo a 5 days baseline ESM data collection (week 0). Upon
      completion of baseline data collection, they will be randomly assigned to the intervention
      (ESM-F), active reference (ESM) or control (CON) group. The participants in the intervention
      group will participate in an ESM procedure (three days per week over a 6-week period) using
      through SMS system (week 1 - 6). This group will receive weekly standardised feedback on
      personalised patterns of positive affect. The active reference group will also participate in
      the same ESM procedure without a weekly feedback. The control group will not be required to
      undergo this 6-week data collection procedure. At week 7, all three groups will undergo
      another 5 days of post-intervention ESM data collection in order to examine the naturalistic
      and interventional changes on the depressive symptoms. From week 8 onwards, the participants
      will be contacted 5 times (week 8, 12, 16, 20 and 32) via telephone to follow-up their
      condition. After 32 weeks, both active reference and control group will receive the report.
    

Intervention name(s): Weekly standardised, personalised feedback
Intervention type(s): Other
Intervention description(s): The ESM-F group will receive standardised ESM-derived feedback immediately followed the weekly ESM data collection procedure, totalling 6 times in the entire intervention period. The feedback will be provided by the researcher in the format of written report and verbal explanation. The feedback on participants' momentary affective state in specific daily life contexts and the association with depressive symptoms will be given. The changes in positive affect level and the number of depressive complaints over the course of the ESM intervention will be shown.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Experience Sampling Method; At risk; Depression; Women; Randomized Controlled Trials; Feedback; Anxiety