bioihbjkbjnl/mcl2 huggingface dataset:
Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes
Condition: Pregnancy; Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      Fetal heart rate patterns are an important parameter in the diagnosis of non-reassuring fetal
      status. Combined-spinal epidural analgesia is a method of initiating labor analgesia used by
      approximately 90% of the parturients at Prentice Women's Hospital. Optimizing the variables
      which could affect fetal heart rate patterns at the time of initiation of analgesia, such as
      fluid administration and oxytocin management, could help us provide better care for our
      patients and their fetuses.

      Hypotheses: Patients who receive a 1000 mL fluid bolus and lower rates of oxytocin
      administration will have fewer non-reassuring fetal heart rate (FHR) changes.
    

Detailed description: 
      Informed, written consent will be obtained. At the time of request for labor analgesia, group
      assignment will be determined by opening an opaque envelope. Patients will be randomized to
      one of four groups.

      All subjects will receive a maintenance infusion of 125 mL Lactated Ringers (LR) solution
      throughout the study. For patients in Groups A or B, an intravenous bolus of 1000 mL LR will
      be initiated when the patient is positioned for epidural placement. The bolus will be
      administered through a free-flowing wide open intravenous catheter until complete.

      Patients in Groups C and D will not receive any additional fluid bolus and will only receive
      the maintenance infusion of 125 mL LR during the study period. Blinding will be maintained by
      the Labor and Delivery nurse by covering up the LR bolus fluid bag.

      If the patient is randomized to groups B or D, the dose of oxytocin currently being
      administered will be halved and not increased for the duration of the study period (60
      minutes after the initiation of CSE).
    

Intervention name(s): Routine oxytocin; Half-dose oxytocin
Intervention type(s): Drug; Drug
Intervention description(s): per regular oxytocin protocols; The dose of oxytocin currently being administered will be halved and not increased until after 60 minutes initiation of labor analgesia
Other intervention name(s): Pitocin; Pitocin
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Oxytocin; Labor, Obstetric; Non-reassuring fetal heart rate; Epidural
Efficacy and Safety Study of Neuramis in Correction of Nasolabial Fold
Condition: Nasolabial Fold
Study type: Interventional
Phase: Phase 3

Summary: 
      This study design is a randomized, multi-center, double Masked, matched Pairs,
      active-controlled clinical trial. Subjects who voluntarily signed the informed consent and
      are judged to be eligible for this study will be intradermally injected both of study device
      and comparator device. Subjects will be randomized to receive injection of study device and
      comparator device on their each nasolabial fold. Efficacy is evaluated based on the change in
      Wrinkle Severity Rating Scale (WSRS) from baseline. Safety will be assessed based on 24 weeks
      follow up visits and subject diary which will be given to subjects during the first 2 weeks
      after the injection. Any uncomfortable things and adverse events will be investigated from
      subeject diary and follow up visits.
    


Intervention name(s): HA filler
Intervention type(s): Device
Intervention description(s): The study device and comparator device will be intradermally injected to each left and right nasolabial fold according to the randomization.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: WSRS; GAIS; HA filler; filler
Adherence in Adolescents and Children Treated on Quetiapine
Condition: Psychosis
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Observational

Summary: 
      Observational study aimed to describe the adherence in a population of adolescents and
      children treated on quetiapine from a first psychotic episode whose more important secondary
      objective is to identify possible predictive factors influencing the adherence to treatment
      with Quetiapine
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Children and adolescents with psychosis in outpatients setting on treatment with quetiapine
        started from january 2003 to june 2006
      
Keywords: Psychosis; adolescents; adherence; quetiapine
To Evaluate the Bioavailability of a Tablet of AZD1656
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the bioavailability of a tablet of AZD1656.
    


Intervention name(s): AZD1656; AZD1656
Intervention type(s): Drug; Drug
Intervention description(s): Single dose oral tablet; Single dose oral suspension
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type I diabetes; bioavailability
Effect of Three Multiple-dose Regimens of BIA 9 1067 at Steady-state on the Levodopa Pharmacokinetics
Condition: Parkinson's Disease (PD)
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effect of BIA 9 1067 (5 mg, 15 mg and 50 mg) in
      steady-state conditions on the levodopa pharmacokinetics of a single dose of
      immediate-release levodopa/carbidopa 100/25 mg and of a single dose of immediate-release
      levodopa/benserazide 100/25 mg.
    

Detailed description: 
      A single-centre, randomized, double-blind, gender-balanced, placebo-controlled study in 4
      groups of 18 healthy subjects each. This study consisted of a once-daily administration of
      BIA 9 1067 (5 mg, 15 mg or 50 mg) or placebo for 18 days. Twelve (12) hours after the BIA 9
      1067 dose, a single-dose of levodopa/carbidopa 100/25 mg was administered on Day 11 and a
      single-dose of levodopa/benserazide 100/25 mg was administered on Day 18.
    

Intervention name(s): BIA 9-1067 5 mg; BIA 9-1067 25 mg; levodopa/carbidopa 100/25; Placebo; levodopa/benserazide 100/25 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): OPC, Opicapone; OPC, Opicapone; immediate (standard) release levodopa/carbidopa 100/25; PLC, Placebo; immediate (standard) release levodopa/benserazide
Other intervention name(s): OPC, Opicapone; OPC, Opicapone; Sinemet®; PLC, Placebo; Madopar®
Intervention MeSH terms: Levodopa; Carbidopa; Opicapone; Benserazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Parkinson's disease (PD); BIA 9-1067; Opicapone
Impact of Early Versus Late Amniotomy on Labour Induction in Nulliparous Women After Vaginal Misoprostol
Condition: Labour Induction
Study type: Interventional

Summary: 
      Investigation the effect of timing of amniotomy (early versus delayed) after vaginal
      misoprostol in induced labor.

      Condition: induction of labour intervention: eary versus late amniotomy on labour induction
      after vaginal misoprostol Phase: Not applicable
    

Detailed description: 
      study type: randomized clinical trial actual enrollment: 140 allocation: Random intervention
      model: two groups assignment masking: open lebal primary purpose: induction of labour actual
      study start: May 3, 2019 Primary Completion: January 10, 2020 actual study completion date:
      March 20, 2020
    

Intervention name(s): Misoprostol
Intervention type(s): Drug
Intervention description(s): rupture of membrane early and late
Other intervention name(s): Amniotomy
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group A: Early amniotomy was performed for the participant of the first group at 3 cm cervical dilatation with Kocher's forceps provided the head is well fitted to the cervix. Group B: late amniotomy was performed for the participant of the second group at 7 cm cervical dilatation.
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Prolonged Inspiratory Time on Gas Exchange During Robot-assisted Laparoscopic Surgery With Steep Trendelenburg Position : A Crossover Randomized Clinical Trial
Condition: Prostatic Neoplasm; Urinary Bladder Neoplasm
MeSH terms: Neoplasms; Prostatic Neoplasms; Urinary Bladder Neoplasms
Study type: Interventional

Summary: 
      Gas exchange disturbance frequently occurs in steep Trendelenburg position during
      robot-assisted laparoscopic prostatectomy or cystectomy. Due to increased intrathoracic
      pressure and absorbed carbon dioxide (CO2) gas insufflated into abdominal cavity, hypercapnia
      as well as hypoxia may occur. Inverse ratio ventilation or prolonged inspiratory time during
      mechanical ventilation has been reported to be improve gas exchange in adult respiratory
      distress syndrome. The investigators attempt to test the hypothesis that prolonged
      inspiratory time may improve the gas exchange during robot-assisted laparoscopic urologic
      surgery.
    

Detailed description: 
      Gas exchange disturbance frequently occurs in steep Trendelenburg position during
      robot-assisted laparoscopic prostatectomy or cystectomy. Due to increased intrathoracic
      pressure and absorbed CO2 gas insufflated into abdominal cavity, hypercapnia as well as
      hypoxia may occur. Inverse ratio ventilation or prolonged inspiratory time during mechanical
      ventilation has been reported to be improve gas exchange in adult respiratory distress
      syndrome. The investigators attempt to test the hypothesis that prolonged inspiratory time
      (I:E ratio = 1:1) may improve the gas exchange during robot-assisted laparoscopic urologic
      surgery.
    

Intervention name(s): Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:2 to 1:1); Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:1 to 1:2)
Intervention type(s): Device; Device
Intervention description(s): Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:2 to 1:1); Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:1 to 1:2)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Pulpal Blood Flow Changes Using SuperElastic 0.018-inch Nickel Titanium
Condition: Orthodontic Appliance
Study type: Interventional

Summary: 
      to record pulpal blood flow (PBF) changes associated with using 0.018-inch Nickel Titanium
      (NiTi) as the first alignment archwire during fixed orthodontic treatment.
    

Detailed description: 
      Forty healthy patients with lower arch mild crowding with less than 2mm contact point
      displacement at any teeth were included. A split mouth study design was applied. Where each
      patient received 2 archwire sizes at one time joined in the midline by crimpable hook and
      applied in the lower arch.

      Patients were assigned into one of 2 groups based on archwire sizes used. Group (1);
      0.014-inch and 0.018-inch NiTi and Group (2); 0.016-inch and 0.018-inch NiTi. A Laser Doppler
      Flowmeter was used to measure PBF at different time intervals (T0-T5).
    

Intervention name(s): 0.014-inch NiTi on one side /0.018-inch NiTi on the other side; 0.016-inch NiTi on one side /0.018-inch NiTi on the other side
Intervention type(s): Procedure; Procedure
Intervention description(s): Where each patient received 2 archwire sizes (0.014-inch and 0.018-inch) at one time joined in the midline by crimpable hook and applied in the lower arch.; Where each patient received 2 archwire sizes (0.016-inch and 0.018-inch) at one time joined in the midline by crimpable hook and applied in the lower arch.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A split mouth study design was applied. Each patient received 2 archwire sizes at one time joined in the midline by crimpable hook and applied in the lower arch. Patients were assigned into one of 2 groups based on archwire sizes used. Group 1:- 0.014-inch and 0.018-inch NiTi Group 2:- 0.016-inch and 0.018-inch NiTi.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pulpal blood flow; Pfixed appliance; Alignment arch wire
A Pilot Methodology Study To Evaluate Changes In Bone Quality Parameters Following Therapy With Forteo
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      This methodology trial will be conducted in patients with osteoporosis and will measure the
      changes in bone quality parameters, micro- and macroarchitecture, bone biomarkers and bone
      density following therapy with the approved drug, Forteo.
    


Intervention name(s): Forteo
Intervention type(s): Drug
Intervention description(s): Open label single arm study with Forteo as an intervention
Other intervention name(s): Recombinant Human PTH 1-34
Intervention MeSH terms: Teriparatide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: 12 month therapy with postmenopausal women with osteoporosis to examine changes in bone quality parameters
Effect of Tactile and Kinesthetic Stimulation on Very Low Birth Weight Preterm Infants
Condition: Preterm Birth
MeSH terms: Premature Birth; Birth Weight
Study type: Interventional

Summary: 
      Two groups of preterm infants with birth weight equal to or less than 1500 grams will be
      studied. One group will receive the standard care and the other will receive standard care
      plus maternal special tactile stimulation. Gain of weight, length and head circumference,
      date of the beginning of enteral feedings, length of time to recover birth weight and age of
      hospital discharge will be recorded and compared between both groups.
    

Detailed description: 
      Preterm infants birth weight equal or less than 1500 grams and gestational age equal or less
      than 32 weeks will be randomized in two groups: standard care that will receive the usual
      treatment applied to all infants admitted to our unit and a second groups that will receive
      standard care plus maternal tactile and kinesthetic stimuli that will be taught to the
      mothers. Randomization will be performed among those that accept to participate in the study.
      Growth (birth, length and head circumference), age of life to start receiving enteral
      feedings, length of hospital stay, time to recover birth weight will be recorded and compared
      between both groups.
    

Intervention name(s): Tactile stimulus
Intervention type(s): Behavioral
Intervention description(s): four times a day
Other intervention name(s): massage therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Efficacy of Dellegra in Exposure Unit
Condition: Rhinitis Allergic
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      To collect and analyze clinical data of Allergic Rhinitis patients' Total Nasal Symptom Score
      (TNSS) change after Dellegra internal use under high density pure Japanese cedar pollen
      exposure.

      Secondary Objective:

      To collect and analyze clinical data of Allergic Rhinitis patients' change in Total Symptom
      Score (TSS) and amount of nasal discharge, safety, and overall patients' impression about
      efficacy of Dellegra after Dellegra internal use under high density pure Japanese cedar
      pollen exposure.
    

Detailed description: 
      It will be 8 days at minimum and up to 17 days depending on screening visit and
      post-treatment observation allowances.
    

Intervention name(s): Fexofenadine HCl 30 mg+Pseudophedrine HCl 60 mg
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form:tablet Route of administration: oral
Intervention MeSH terms: Fexofenadine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Immunogenicity of a Candidate RVFV Vaccine (RVF001)
Condition: Rift Valley Fever
MeSH terms: Coccidioidomycosis; Coccidiosis; Rift Valley Fever; Fever
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Phase I open label, non-randomised dose escalation study on healthy UK volunteers aged from
      18 to 50 years to assess the safety and immunogenicity of ChAdOx1 RVF
    

Detailed description: 
      The purpose of this study is to test a new vaccine against the Rift Valley Fever Virus (RVFV)
      in healthy volunteers.

      Rift Valley fever is a disease caused by RVFV and it is transmitted to humans through a
      mosquito bite or contact with virus-contaminated tissues and fluids. Although initially
      restricted to Africa, the virus can be transmitted by several different mosquito species that
      are more widely distributed than the virus itself, leading to concerns of disease spread as
      has occurred in the Arabian Peninsula and Madagascar. In humans, RVFV infection usually
      presents as a sudden febrile illness, but severe manifestations including bleeding disorders
      and neurological complications may also occur. RVFV is considered a global health threat with
      significant potential for international spread and use in bioterrorism.

      Vaccines against RVFV are available for livestock, however no licensed vaccines or specific
      treatments are currently available for humans.

      The study will enable assessment of the safety of the new vaccine called ChAdOx1 RVF and the
      extent of immune response in healthy volunteers. Healthy adult volunteers will receive a
      single dose of a new candidate vaccine at different doses. The objective of this
      first-in-human study is to find the optimal dose of the vaccine, balancing immune responses
      and profile of adverse events.

      Healthy volunteers aged 18-50 will be recruited in Oxford and vaccinated at the Centre for
      Clinical Vaccinology and Tropical Medicine and will be followed for a period of 3 months. The
      study is funded by the UK Biotechnology and Biological Sciences Research Council(BBSRC) and
      the Medical Research Council (MRC)/Department of Health, through the UK Vaccines Network.
    

Intervention name(s): ChAdOx1 RVF
Intervention type(s): Biological
Intervention description(s): Single dose of ChAdOx1 RVF
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RVF; ChAdOx1; vaccine
A Dose Escalation Study of IBI324 in Subjects With Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed as a Multi-center, open-label, dose escalation phase I trial to
      evaluate the safety and tolerability of a single and multiple intravitreal injections of
      IBI324 in subjects with DME
    


Intervention name(s): IBI324; IBI324; IBI324; IBI324; IBI324
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Dose 2 IBI324 of multiple IVT injection; Dose 2 IBI324 of single IVT injection; Dose 1 IBI324 of single IVT injection; Dose 3 IBI324 of single IVT injection; Dose 3 IBI324 of multiple IVT injection
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of a Depigmented Extract of Phleum in Local Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is evaluate the efficacy of a depigmented grass extract in the
      treatment of local allergic rhinitis.
    


Intervention name(s): DEPIGOID phleum; DEPIGOID Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Subcutaneous Immunotherapy with modified extract of Phleum pollen.; Placebo for subcutaneous administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of WPV01 in Healthy Subjects
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WPV01
      and WPV01 Co-administrated With Ritonavir in Healthy Adult Subjects.
    


Intervention name(s): WPV01 Dose 1-4; WPV01 Dose 5-8 and Ritonavir; WPV01 Dose 9-12; WPV01 Dose 13-15 and Ritonavir; WPV01 Dose 16
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): WPV01 Dose 1-4 or Placebo on day 1; WPV01 Dose 5-8 and Ritonavir or Placebo on day 1; WPV01 Dose 9-12 or Placebo from day 1 to day 6; WPV01 Dose 13-15 and Ritonavir or Placebo from day 1 to day 6; Cohort 1:WPV01 Dose 16 or Placebo (with high fat meal) Cohort 2:WPV01 Dose 16 or Placebo (fasted)
Intervention MeSH terms: Ritonavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment