bioihbjkbjnl/mcl2 huggingface dataset:
Study of Vaginal Dilator Use After Pelvic Radiotherapy
Condition: Cervical Cancer; Endometrial Cancer; Rectal Cancer; Anal Cancer
MeSH terms: Endometrial Neoplasms; Anus Neoplasms
Study type: Observational

Summary: 
      Patient will have radiation to treat the cancer. This treatment can make the vagina both
      narrower and shorter. That can cause two problems. It can make it harder for the doctor to do
      a pelvic exam during a follow-up visits. And, it can make sexual intercourse uncomfortable.

      We tell women to use a vaginal dilator after radiation to the pelvis. This is standard
      education. We do not routinely ask women how they do with it. We are doing this study to see
      if using the dilator as we instruct will help the vagina stretch. The patient will have an
      examine of the vagina before the start of radiation. We will see what size dilator can fit.
      The goal of this study is to have the patient be able to use that size dilator within six
      months after radiation.
    


Intervention name(s): Vaginal Dilator
Intervention type(s): Device
Intervention description(s): Participants will be instructed to use the dilators 3 times per week, regardless of frequency of sexual intercourse. At 5 time points, data will be collected to determine vaginal dilator size, grade vaginal stenosis & assess vaginal symptoms. 1)Baseline: patient self-assessment following consultation up until the end of the first week of radiation 2)Post-radiation: patient self-assessment one month ± 2 weeks follow-up from last day of radiation 3)Post-radiation: 3 month ± 4 weeks follow-up from initiation of dilator use 4)Post-radiation: 6 month ± 4 weeks follow-up from initiation of dilator use 5)Post-radiation: 12 months ± 4 weeks follow-up from initiation of dilator use. At the 1st & 2nd time points, the nurse will telephone the patient to retrieve her responses. The 1st phone call will occur between the time following consultation up until the end of the first week of radiation, & the 2nd will be one month ± 2 weeks from last day of radiation.
Other intervention name(s): The remaining assessments will be performed during the patient's regularly; scheduled follow-up appointments or via phone calls.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All women seen in the radiation oncology clinic with cervical, endometrial, rectal or anal
        cancer who will receive external beam pelvic radiation or brachytherapy.
      
Keywords: external beam pelvic radiation; brachytherapy
Severe Complications Triplicate the Costs of Major Surgical Procedures
Condition: Major Surgical Procedures
Study type: Observational

Summary: 
      The purpose of this study is to prospectively assess the impact of surgical quality on the
      overall cost of major surgical procedures using the incidence and severity of complications
      as surrogate markers of quality.
    

Detailed description: 
      To prospectively assess the impact of surgical quality on the overall cost of major surgical
      procedures using the incidence and severity of complications as surrogate markers of quality
    

Intervention name(s): No additional intervention than the intended major surgery in pancreas, liver, colorectal, gastric bypass and small bowel
Intervention type(s): Other
Intervention description(s): No additional intervention than the intended major surgery (liver, bile duct, pancreas, colorectal, gastric bypass and small bowel resections) comparing with costs
Intervention MeSH terms: Pancrelipase
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        A cohort study with 1235 patients including consecutive patients undergoing major surgery
        (liver, bile duct, pancreas, colorectal, gastric bypass and small bowel resections) in a
        single tertiary care center
      
Keywords: Clinical outcome (complications), in-hospital costs; The influence and impact of postoperative complications on in-hospital costs
Sculptra for Décolletage Crepiness and Wrinkling
Condition: Décolletage
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of Sculptra as a volume
      agent to improve décolletage crepiness and wrinkling.
    


Intervention name(s): Sculpta
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Bioequivalence Study Comparing Clopidogrel/Aspirin Combination Tablet With Coadministration of Clopidogrel and Aspirin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate pharmacokinetics and safety after oral
      administration of clopidogrel and aspirin in free combination as HCP0911.
    


Intervention name(s): HCP0911 / clopidogrel, aspirin
Intervention type(s): Drug
Intervention description(s): combination tablet vs coadministration
Intervention MeSH terms: Aspirin; Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: clopidogrel; aspinin; combination
An Diagnostic Cohort on AQP4-Immunoglobulin G Detection Kit
Condition: Neuromyelitis Optica Spectrum Disorders
MeSH terms: Neuromyelitis Optica
Study type: Observational

Summary: 
      The diagnostic cohort study could will be use to verify the clinical performance of the AQP4
      -immunoglobulin G detection kit and whether it has a good correlation with the clinical
      diagnosis results. The applicability and accuracy of the kit in clinical diagnosis will be
      verified according to the measured data.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with NMOSD who are diagnosied in the First Affiliated Hospital of Fujian Medical
        Universtiy by two neurolgists
Stabilometry After Pressure Release of the Flexor Digitorum Brevis Muscle Versus a Non-emission Laser: Clinical Trial
Condition: Flatfoot
MeSH terms: Flatfoot
Study type: Interventional

Summary: 
      Thirty-six subjects randomly distributed between a pressure release intervention group and a
      control group whose intervention is a non-emission laser. All the subjects will be measured
      before and after the interventions of each group. The measurements will be made on a pressure
      platform to record the stabilometry variables.
    

Detailed description: 
      Thirty-six subjects randomly distributed between a pressure release intervention group and a
      control group whose intervention is a non-emission laser. All the subjects will be measured
      before and after the interventions of each group. The measurements will be made on a pressure
      platform to record the stabilometry variables with eyes closed and open.
    

Intervention name(s): Bilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger point; Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle
Intervention type(s): Other; Other
Intervention description(s): Bilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger point; Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Foot; stabilometry; trigger point
Bioequivalence Study of Ondansetron Orally Disintegrating Tablets 8mg Under Fasting Conditions
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to compare the single-dose oral bioavailability of Ondansetron 8
      mg orally disintegrating tablets of OHM Laboratories Inc (A subsidiary of Ranbaxy
      Pharmaceuticals Inc, USA) with Zofran ODT® 8 mg orally disintegrating tablets of
      GlaxoSmithKline, USA in healthy, adult, human, male subjects under fasting condition.
    

Detailed description: 
      The study was conducted as an open label, balanced, randomised, two-treatment, two-period,
      two-sequence, single-dose, crossover bioavailability study comparing Ondansetron 8 mg orally
      disintegrating tablets of OHM Laboratories Inc (A subsidiary of Ranbaxy Pharmaceuticals Inc,
      USA) with Zofran ODT® orally disintegrating tablets (containing 8 mg of ondansetron) of
      GlaxoSmithKline in healthy, adult, human, male subjects under fasting condition.

      During each period of the study after an overnight fast of at least 10 hours, a single oral
      dose of either test or reference product was administered by placing the tablet on tongue
      till it dissolved and then swallowed it using 240 mL of drinking water at ambient temperature
      under supervision of a medical officer.

      During the course of the study, safety parameters including vital signs, clinical
      examination, medical history and clinical laboratory safety tests (hematology, biochemical,
      serology parameters and urine analysis) were assessed and laboratory parameters of hematology
      and biochemistry were repeated at the end of the study.
    

Intervention name(s): Ondansetron
Intervention type(s): Drug
Intervention description(s): Orally Disintegrating Tablets 8mg
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Minerva Pivotal Study to Evaluate Safety and Efficacy of the Aurora Endometrial Ablation System Compared to Hysteroscopic Rollerball Ablation
Condition: Menorrhagia
MeSH terms: Menorrhagia
Study type: Interventional

Summary: 
      The primary objective of this study is to evaluate the safety and effectiveness of the Aurora
      Endometrial Ablation System as compared to hysteroscopic rollerball endometrial ablation in
      reducing menstrual blood loss at 12 months post-treatment.
    

Detailed description: 
      Menorrhagia is defined as menstrual bleeding in the ovulatory woman exceeding 80 ml per
      month. Approximately 20-25% of healthy premenopausal women have abnormal uterine bleeding.
      Menorrhagia can have a negative impact on a woman's lifestyle and self-perception, often
      leading her to seek definitive treatment. Pharmacologic treatment for menorrhagia is not
      always successful, and dilatation and curettage typically provides relief for only a few
      menstrual cycles. Traditionally hysterectomy has been the definitive treatment for
      menorrhagia. This clinical study evaluates the safety and effectiveness of the Aurora
      Endometrial Ablation System to provide a therapeutic treatment for menorrhagia due to benign
      causes by ablating the endometrial lining of the uterus in pre-menopausal women for whom
      childbearing is complete. Subjects who are randomized to the control group will receive
      hysteroscopic rollerball/resection ablation. Subjects randomized to the test arm will be
      treated with the Aurora Endometrial Ablation System.
    

Intervention name(s): Aurora Endometrial Ablation; Rollerball Ablation/Resection
Intervention type(s): Device; Device
Intervention description(s): Endometrial Ablation using the Aurora Endometrial Ablation system; Hysteroscopic rollerball resection/ablation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: endometrial ablation
MAVERICK™ Total Disc Replacement- Pivotal Study
Condition: Spinal Diseases
MeSH terms: Spinal Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this clinical trial is to assess the safety and effectiveness of the MAVERICK™
      Total Disc Replacement as a method of treating patients with lumbar degenerative disc disease
      at one level from L4-S1, with overall success being the primary endpoint of the clinical
      trial. The primary objective is to show non-inferiority of the investigational device to the
      control treatment. If non-inferiority is established, superiority will be examined.
    

Detailed description: 
      For this clinical trial, there are two treatment groups, i.e., investigational patients who
      receive the MAVERICK™ Total Disc Replacement and control patients who receive the anterior
      lumbar interbody fusion procedure with INFUSE® Bone Graft/LT-CAGE® Lumbar Tapered Fusion
      Device. Each investigational site will enroll patients in a 2:1 investigational:control
      treatment randomization scheme.
    

Intervention name(s): MAVERICK™ Disc; LT-CAGE® Lumbar Tapered Fusion Device and INFUSE® Bone Graft
Intervention type(s): Device; Device
Intervention description(s): The MAVERICK™ disc is a spinal arthroplasty system and is intended to replace a damaged disc in the lumbar spine. It is a permanent implant used to maintain motion at the treated level and is inserted using an anterior surgical approach.; The control is the treatment with LT-CAGE® Lumbar Tapered Fusion Device and INFUSE® Bone Graft. It is commercially available for anterior lumbar spine interbody fusion procedures.
Other intervention name(s): MAVERICK™; Fusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lumbar degenerative disc disease at one level from L4-S1
Effect of Rice Fortification With Iron on Anemia Among Children
Condition: Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This was a double-blind community-based trial, placebo controlled. During 16 weeks, children
      in the intervention group (GI, n=180) received iron fortified rice, and children in the
      control group (GC, n=174) received rice with placebo. Anemia was considered present when
      hemoglobin < 11.0g/dL. Comparison of mean variation on hemoglobin between groups was accessed
      by using Student's t-test. Hemoglobin concentration improved in both groups, with mean
      increase of 0.42 g/dL in GI (11.28±1.23 g/dL to 11.75±1.16 g/dL, p < 0.001), and 0.49 g/dL in
      GC (11.06±1.13 g/dL to 11.51±1.16 g/dL, p < 0.001). Anemia decreased (p < 0.01) in both
      groups (37.8% to 23.3% in GI and 45.4% to 33.3% in GC), with no differences between them.
      Hemoglobin increase was significantly higher in children who received total amount of iron ≥
      53.76 mg from fortified rice, compared to those who received less than this cut-off value
      (0.94 g/dl vs 0.39 g/dl p=0.03). The results suggest that this type of intervention can be
      useful in anemia control if fortified food intake is adequate.
    


Intervention name(s): iron bisglycine chelate; placebo
Intervention type(s): Other; Other
Intervention MeSH terms: Chelating Agents
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
The Standing and Sitting Spino-pelvic Sagittal Alignment in Chinese Population
Condition: Sagittal Alignment
Study type: Observational

Summary: 
      This study is aimed to demonstrate the standing and sitting spino-pelvic sagittal alignment
      in Chinese population, then to explore the influence of spinal fusion on the changes when
      moving from standing to sitting positon.
    


Intervention name(s): whole spine X-ray
Intervention type(s): Radiation
Intervention description(s): Group 1 underwent whole spine X-ray in standing and sitting positions.
Observational model: Case-Control
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Healthy Volunteers Patients with lumbar degenerative disease who had undergone surgery in
        Peking university third hospital.
      
Keywords: sagittal alignment; sitting; spinal fusion
PK Study of ACHN-490 Injection in Renally Impaired Subjects
Condition: Renal Insufficiency
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study is to assess the relationship between renal function and
      pharmacokinetics of ACHN-490 Injection.
    


Intervention name(s): ACHN-490 Injection
Intervention type(s): Drug
Intervention description(s): 7.5 mg/kg single dose administered intravenously over 30 minutes
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PK study
The Effects of Gabapentin Premedication on Neurosurgery
Condition: Cerebral Tumor
Study type: Interventional

Summary: 
      The study is to observe the effects of gabapentin premedication on postoperative
      pain,vomiting and nausea in patients undergoing neurosurgery. 100 neurosurgical patients are
      randomized into groups gabapentin(GG) or placebo(GP). Patients are given gabapentin or
      placebo orally the night before operation day and 2hours before surgery,respectively.The
      investigators hypothesized that lower incidence of postoperative pain,vomiting and nausea be
      observed in GG than GP.
    

Detailed description: 
      This is a random, double-blind study. In GG, patients are given gabapentin 600mg orally at
      the night and 2hours before surgery, respectively. In PG, vitamine pills are given
      instead.Total intravenous anesthesia is applied for all patients. 1hour, 2hours,1day, 2days,
      3months and 6months after surgery, patients are evaluated for pain (VAS) and incidence of
      PONV. In addition,Glasgow Score, Ramsay Score and other gabapentin-related effects, such as
      somnolence,dizzy or dry mouth are also observed.The incidence of persistent pain and
      neuropathic pain was assessed at the 3-mo and 6-mo postoperative evaluation.
    

Intervention name(s): gabapentin; vitamin capsules
Intervention type(s): Drug; Drug
Intervention description(s): gabapentin capsules 0.3g; vitamin B
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: gabapentin; postoperative pain; vomiting; nausea
The Use of Jet Injection Lidocaine for Blood Draws in Young Children
Condition: Pain
Study type: Interventional

Summary: 
      This study looks at the use of Jet Injection Lidocaine (J tip) for pain during blood draws in
      children ages 6 and younger. The investigators will use video observation of patients to
      asses their pain during lab draws using either 1) Jet Injected lidocaine ( J tip) 2) Pain
      Ease spray 3) Pain Ease spray plus the J tip noise.
    

Detailed description: 
      No change since last report.
    

Intervention name(s): J tip; Pain Ease Spray; 1% buffered lidocaine; placebo cooling spray (normal saline spray); Sucrose
Intervention type(s): Device; Other; Drug; Other; Other
Intervention description(s): This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine; Cold Spray used to anesthetize the skin; Lidocaine placed using Jet Injection; Normal Saline Sprayed as placebo for Pain Ease spray; Oral Sucrose used for children < 1 year
Other intervention name(s): Cooling Spray; Lidocaine; Normal Saline Spray; Sweetease
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; Children; Venipuncture; J tip; Lidocaine; video observation
Effect of Thoracic Spine Mobilization on Sympathetic Nervous Systems
Condition: Erythema
MeSH terms: Erythema
Study type: Observational

Summary: 
      This pilot study aims to i) represents the feasibility of the study design and ii) to point
      out acute effects of thoracic spine mobilization on skin-blood flow, erythema and the
      sympathetic nervous system.
    


Intervention name(s): Mobilization anterior; Mobilization posterior
Intervention type(s): Procedure; Procedure
Intervention description(s): Participant in prone position. Central thoracic mobilization from posterior-to-anterior.; Participant in sitting position. Central thoracic mobilization from anteriors-to-posterior.
Other intervention name(s): Thoracic spine mobilization with anterior pressure; Thoracic spine mobilization with posterior pressure
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy person between 20 and 30 years.
      
Keywords: Skin blood flow; Skin redness; Sympathetic nervous system; Regional Blood Flow
Effects of RG1068 (Secretin) on Information Processing in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The overarching purpose of the proposed study is to determine Secretin's (RG1068)
      psychophysiological effects on measures of motor learning, affective, and inhibitory
      information processing in individuals with schizophrenia. Motor learning will be assessed
      with a classical eye-blink conditioning procedure, requiring the learning of a reflexive
      eye-blink response to a weak puff of air to the eye.
    

Detailed description: 
      In a recent placebo-controlled, double-blind, multicenter study of Secretin in refractory
      schizophrenics, we found that a patient who received Secretin (1.0 g/kg) intravenously,
      showed a marked improvement in eye blink conditioning following infusion. This subject also
      showed a clinical improvement of > 20% on the Total Score and Total Negative Score of the
      Positive and Negative Syndrome Scale (PANSS). Therefore, the primary objective of this study
      is to confirm and extend this observation in a larger group of individuals with
      schizophrenia. In this 24 to 48 hour experiment, the acquisition and extinction of the
      conditioned blink response will be assessed in participants with schizophrenia who are
      randomly assigned to one of two double blind treatment groups: (1) subcutaneous saline or (2)
      subcutaneous Secretin (20 ug/kg). Enrolled participants will remain on their stable
      medication regime (i.e., psychotropic medications and related treatments will not be
      manipulated). Furthermore, given evidence that Secretin administration increases the
      amygdala's activation during experimental presentation of fear-related facial cue stimuli, we
      wish to also investigate the effects of the experimental agent on psychophysiological
      processes putatively related to amygdala function. Prepulse inhibition is a widely studied
      paradigm in the schizophrenia literature, thought to reflect disruption of early
      sensory-motor gating that is present in both individuals with schizophrenia and their
      unaffected biological relatives, and can be mediated by various limbic structures including
      the amygdala. Therefore, as a secondary aim, the effects of Secretin will be tested on affect
      modulation, pre-pulse inhibition, and pre-pulse facilitation of the acoustic startle response
      using common psychophysiological research procedures. These procedures are frequently used in
      our laboratory and are currently approved for our use by the IRBs at both IUPUI and IUB.
    

Intervention name(s): Subcutaneous Secretin
Intervention type(s): Drug
Intervention MeSH terms: Secretin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Schizophrenia; Secretin