bioihbjkbjnl/mcl2 huggingface dataset:
Benefits of Hysteroscopy Prior to Performing a Cycle of in Vitro Fertilization/Intracytoplasmic Sperm Injection
Condition: Sterility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      This is a prospective randomized open-label trial. Women scheduled for their first or second
      in-vitro fertilization/intracytoplasmatic Sperm Injection (IVF/ICSI) cycle and with no
      abnormality detected in transvaginal ultrasound examination, were randomized to two groups.
      In the first group (group I) 31 patients underwent hysteroscopy examination before IVF cycle
      while in the second group (group II) 37 patients underwent direct cycle without previous
      hysteroscopy
    

Detailed description: 
      This is a prospective randomized open-label trial. Women scheduled for their first or second
      IVF/ICSI cycle and with no abnormality detected in transvaginal ultrasound examination, were
      randomized to two groups. In the first group (group I) 31 patients underwent hysteroscopy
      examination before IVF cycle while in the second group (group II) 37 patients underwent
      direct cycle without previous hysteroscopy. Then IVF cycle was performed with habitual
      protocol. Beta Corionic Gonatropic hormone (BhCG) test two weeks after embryo transfer was
      done. If test was positive, patients were followed up for detection pregnancy by transvaginal
      ultrasound two weeks later. Another transvaginal ultrasound at 12 weeks of gestation was done
      to confirm ongoing pregnancy. Biochemical pregnancy, implantation, on-going pregnancy and
      livebirth rates were compared in both groups.

      Miscarriage, complications rate and hysteroscopy tolerability were also analyzed.
    

Intervention name(s): Hysteroscopy
Intervention type(s): Procedure
Intervention description(s): The hysteroscopy is the visualization of the cervical canal and uterine cavity with a camera. Patients randomized to group I underwent hysteroscopy prior to the IVF cycle.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized open-label clinical trial. Women scheduled for their first or second IVF/ICSI cycle and with no abnormality detected in transvaginal ultrasound examination, were randomized to two groups.
In the first group (group I): 31 patients underwent hysteroscopy examination before IVF cycle.
The second group (group II): 37 patients underwent direct cycle without previous hysteroscopy.
Masking: None (Open Label)
Primary purpose: Diagnostic
Clinical Research of Femtosecond Laser-Assisted Cataract Surgery
Condition: Cataracts
MeSH terms: Cataract
Study type: Interventional

Summary: 
      Since femtosecond laser was approved for cataract surgery by FDA in 2010, femtosecond laser
      assisted cataract surgery (FLACS) has demonstrated high precision of capsulotomy, reduced
      phacoemulsification power and time, and comparable refractive outcome in clinic.

      It is still unknown whether there are toxic substances produced due to photochemical or
      high-energy physical effect of femtosecond laser during FLACS.
    

Detailed description: 
      Phacoemulsification is one of the main surgical procedures for cataract surgery owing to the
      advantages of small incisions and rapid recovery. However, the surgical outcome of
      phacoemulsification can be negatively affected due to the problem of accuracy and
      repeatability for capsulorhexis, and the corneal endothelial cell damage by ultrasound
      energy.To overcome those problems from the phacoemulsification, femtosecond laser-assisted
      cataract surgery (FLACS) had been used in the past few years and showed unique advantages.

      The purpose of this study is to investigate the preliminary clinical outcomes of femtosecond
      laser-assisted cataract surgery.This prospective comparative study enrolled consecutive
      patients,will be randomly assigned to trial group underwent FLACS and control group underwent
      conventional cataract surgery.

      The phacoemulsification time, energy, and complications during operation were recorded.

      The anterior capsule and aqueous humor were collected. Morphology of the cutting edge and
      cells of anterior capsule was assessed by light microscopy. The proteins in the aqueous humor
      were identified by mass spectrometry . Electrolyte in the aqueous humor was detected by a
      chemistry analyzer. Postoperative refraction at 1 day, 1 week, 1 and 3 months, the
      capsulorhexis size and corneal endothelial density at 1 and 3 months were also measured.
    

Intervention name(s): femtosecond laser-assisted cataract surgery; conventional phacoemulsification
Intervention type(s): Procedure; Procedure
Intervention description(s): the femtosecond laser platform was used to generate capsulotomy with a diameter as described above in the control group, and lens fragmentation into 6 segments.; continuous curvilinear capsulorhexis was performed with capsulorrhexis forceps. Following hydrodissection, phacoemulsification of the nucleus, aspiration of the residual cortex and capsular polishing were performed using a phacoemulsification machine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: femtosecond laser
A Study to Compare the Taste and Levels in Blood Plasma of BMS-986165 When Taken as Different Formulations by Healthy Adult Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the taste, and the levels in blood plasma of
      different tablet formulations of BMS-986165 when taken by healthy adults.
    


Intervention name(s): BMS-986165 Tablet formulation 1; BMS-986165 Tablet formulation 2
Intervention type(s): Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Deucravacitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
RCT for Intermittent Versus Continuous Propofol Sedation for Pediatric Brain and Spine MRI Studies
Condition: Encephalopathy; Developmental Delay and Behavioral Changes; Cord Tumor Compression or Instability; Cord Tethering or Malformation
MeSH terms: Brain Diseases
Study type: Interventional

Summary: 
      RCT for Intermittent versus Continuous Propofol Sedation for Pediatric Brain and Spine MRI
      Studies
    

Detailed description: 
      A study comparing the dose of propofol used as a continuous infusion versus intermittent
      bolus dosing looking at recovery time complications, and quality of the MRI studies in
      Pediatric Sedation Services for patients age 1 month to 18 years receiving an brain or spine
      MRI.
    

Intervention name(s): Intermittent Propofol Sedation; Continuous Propofol Sedation
Intervention type(s): Procedure; Procedure
Intervention description(s): Intermittent versus continuous dosage; intermittent vs continuous dosage
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sedation; MRI; pediatric; propofol; brain; spine; quality of MRI; Continuous propofol dosing; continuous propofol administration; Intermittent propofol dosing; intermittent propofol administration; Sedative agent; propofol continuous infusions; Recovery time; Complications of sedation; bolus dosing
Laryngeal Mask or Endotracheal Tube for Back Surgery in the Prone Position
Condition: Anaesthesia; Adverse Effects
Study type: Interventional

Summary: 
      The aim of the study is to compare anaesthesia (for back surgery) using endotracheal
      intubation (patients anaesthized in the supine position)with anaesthesia using a laryngeal
      mask (anaesthesia induced and the laryngeal mask placed with the patient in the prone
      position on the operation table) as regards advantages, adverse effects and time spent. The
      anaesthesia in the 2 groups of patients is identical (propofol, remifentanil, rocuronium).
      Two groups of 70 pt. each are included in the stud. The inclusion criterias are patients
      18-70 yrs., ASA group 1-2, normal airways, patients scheduled for back surgery with an
      estimated duration of less than 2 hours.

      Adverse effects (related to the placement on the operation table i.e. pain in the arms or
      shoulders, pain in the throat, blood in the sputum, irritation in the eyes etc.) and time
      spent with all the procedures (anaesthesia, placement of the airway, surgery and emergence
      from the anaesthesia are registered. The hypothesis is that the method using the laryngeal
      mask is faster and with fewer adverse effects.
    


Intervention name(s): laryngeal mask; endotracheal tube
Intervention type(s): Device; Device
Intervention description(s): LMA Proseal; Unomedical endotracheal tube
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anaesthesia; laryngeal mask; prone position
A Component Analysis of Acceptance and Commitment Therapy
Condition: Long-term Physical Health Conditions; Mild to Moderate Anxiety and/or Depression
MeSH terms: Disease
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a specific component of Acceptance and
      Commitment Therapy (ACT) called 'Self as Context' is an important and necessary part of this
      therapeutic approach.
    


Intervention name(s): Acceptance and Commitment Therapy
Intervention type(s): Behavioral
Intervention description(s): Half of the participants will receive an eight-session ACT intervention whereby each component of the psychological flexibility model will be covered. Half of the participants will receive an eight-session act intervention whereby each component except self as context will be covered.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Risk of Umbilical Trocar-site Hernia After SILC Cholecystectomy Versus Conventional Cholecystectomy
Condition: Cholecystolithiasis; Incisional Hernia
MeSH terms: Cholecystolithiasis; Cholelithiasis; Gallstones; Hernia; Incisional Hernia
Study type: Observational

Summary: 
      Background Laparoscopic cholecystectomy is a very common procedure. Postoperative pain,
      especially around the umbilical port is dominating the first postoperative week. Single
      Incision Laparoscopic cholecystectomy (SILC) has been proposed to diminish postoperative
      incisional pain and improve cosmetic results, but results are not convincing and the risk of
      formation of an umbilical trocar-site hernia is not properly investigated.

      This study aimed to investigate the risk of umbilical trocar-site hernia formation after SILC
      vs. conventional 4-port laparoscopic cholesystectomy.

      Methods This is a cohort registry study with prospective questionnaire and clinical follow-up
      on 239 patients having a SILC from 1/1 2009 to 1/6 2011 vs. 478 mathed patients having a
      conventional laparoscopic cholecystectomy (consecutively from one month before and after
      SILC. They are matched for age, gender, date of operation, and surgeons skills (database from
      intraoperatively registered data). Primary endpoint is umbilical trocar-site hernia formation
      (operation for a umbilical hernia or clinical hernia).

      The H0 hypothesis is that there is not difference between SILC and conventional.

      Exclusion criteria are: death, operation for acute cholecystitis. The included patients will
      be sent a questionnaire asking for operation for a hernia in the area, suspicion of a hernia,
      and perioperative data that we do not have in the database. Futhermore those patients who
      suspect a hernia will be invited to aclinical exam by a medic to state the diagnosis.
      Furthermore we patients are asked to report if they have chronic pain and/or discomfort.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patient having a SILC in Denmark from 1/1-2009-1/6-2011 and matched conventional lap.
        cholecystectomies. Matched in gender, age, surgeons ecxperience
      
Keywords: SILC; lap. cholecystectomy; trocar-site hernia
Virtual Reality Treatment for Adults With Chronic Back Pain
Condition: Chronic Pain; Back Pain Lower Back Chronic; Back Pain
MeSH terms: Back Pain; Chronic Pain
Study type: Interventional

Summary: 
      Participants with chronic back pain will complete an online eligibility questionnaire. After
      signing a consent form, eligible participants enter a two-week baseline period ("Baseline
      Period") during which they complete a daily pain survey. Following the Baseline Period all
      participants complete an MRI scan. After the MRI, scan participants are randomized into a
      treatment group ("Therapy Group") or a no-intervention group ("Standard of Care Group" or
      "SOC Group") with a ratio of 1:1 (treatment:SOC). Therapy Group participants receive
      education about chronic pain. They also participate in sessions to personalize their Virtual
      Reality (VR) experience, and to complete training on the use of the VR hardware and software.
      Therapy Group participants complete the treatment for 8 weeks ("Therapy Period"), after which
      they return the VR equipment. All participants take a second MRI scan approximately 8-weeks
      after the first MRI; for the Therapy Group this is at the end of the Therapy Period. After
      the Therapy Period, Therapy Group participants continue to complete daily pain surveys during
      a two-week follow-up period ("Follow-Up Period"). All participants complete self-reported
      clinical outcomes and behavioral measures surveys before and after the Baseline Period, 4
      weeks after the first MRI (for Therapy Group this is mid-way through the Therapy Period), and
      before and after the Follow-Up Period. For Therapy Group participants the study ends with the
      final surveys and an exit interview at the end of the Follow-up Period. Study Extension
      (Add-on): SOC Group participants may receive the treatment after the Follow-Up period. Those
      who elect to do so will complete the same set of surveys as the Therapy Group did during the
      treatment phase; however, since there is no comparison group, data from this study extension
      is not used in the main outcomes analyses.
    


Intervention name(s): Virtual Reality Therapy for Chronic Pain
Intervention type(s): Device
Intervention description(s): A 1 1/2 PowerPoint-based education session on the science behind chronic pain and a basic overview of the VR therapy
Virtual Reality Therapy: a virtual reality therapy consisting of different psychological training exercises
Other intervention name(s): Virtual Reality Neuropsychological Therapy (VRNT)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
An Open-Label Study of Trofinetide for the Treatment of Girls Two to Five Years of Age Who Have Rett Syndrome
Condition: Rett Syndrome
MeSH terms: Rett Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To investigate the safety and tolerability of long-term treatment with oral trofinetide in
      girls with Rett syndrome
    


Intervention name(s): Trofinetide
Intervention type(s): Drug
Intervention description(s): Trofinetide solution of 10-30 mL based on subject's weight at Baseline, administered twice daily by mouth or gastrostomy tube (G-tube)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Matrix Metalloproteinases's in Oral Biofluids During Pregnancy and Postpartum
Condition: Pregnancy
Study type: Observational

Summary: 
      The aim of this study was to investigate salivary and gingival crevicular fluid (GCF) levels
      of MMP-8, MMP-9 and TIMP-1 during 2/3 trimester of pregnancy and after delivery
    

Detailed description: 
      MMP-8 and MMP-9 have been reported to reflect the inflammatory status in periodontal tissues
      and, therefore represent as potential biomarkers of periodontitis. The balance between tissue
      inhibitors of metalloproteinases (TIMPs) and MMPs play an important role in maintaining the
      integrity of healthy periodontium.
    

Intervention name(s): Saliva collection; GCF collection
Intervention type(s): Other; Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All women were systemically healthy
      
Keywords: gingivitis; saliva; gingival crevicular fluid
NeuroModulation Technique Treatment of Autism
Condition: Autism; Neurodevelopmental Disorder
MeSH terms: Autistic Disorder; Neurodevelopmental Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether NeuroModulation Technique (NMT) is
      effective in reducing maladaptive behaviors and increasing adaptive behaviors in children
      diagnosed with autism.

      Hypothesis: Children in the Experimental group will show significant improvement over the
      Wait-List control group as measured by the Pervasive Developmental Disorder Behavioral
      Inventory (PDDBI), the Aberrant Behavior Checklist, Community Version (ABC-C), and the Autism
      Treatment Evaluation Checklist (ATEC). Children in the Wait-List control group will show
      significant improvement over their baseline measures after receiving NMT treatment.
    


Intervention name(s): NeuroModulation Technique
Intervention type(s): Behavioral
Intervention description(s): NeuroModulation Technique is an informational technique that works by identifying and bringing awareness of the mind-body to incorrect informational states of the nervous system which has led to illness or maladaptive behavior. NeuroModulation Technique then directs the body to correct these information states, thereby helping the nervous system resume more adaptive functioning.
Other intervention name(s): NMT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autism; Neurodevelopmental disorder
Risperidone Tablets, 1 mg Bioequivalence Study of Dr.Reddy's Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A Single-dose, Randomized, two-Period, Cross over Study
    

Detailed description: 
      Randomized, single-dose, two-way, crossover study was conducted to compare the relative
      bioavailability of two formulations of 1 mg risperidone tablets under fasting conditions.

      The test formulation was Dr. Reddy's Laboratories Limited's Risperidone Tablets, 1 mg, and
      the reference formulation was Risperdal® (risperidone) tablets, 1 mg (Janssen Pharmaceutica
      Products, L.P.).

      The study was conducted with 30 healthy adults. In each study period, a single 1 mg dose was
      administered to all subjects following an overnight fast.The subjects received the test
      product in one study period and the reference product in the other period; the order of
      administration was according to the dosing randomization schedule. There was a 7-day interval
      between treatments.
    

Intervention name(s): Risperidone
Intervention type(s): Drug
Intervention description(s): Risperidone Tablets 1 mg
Other intervention name(s): Risperdal® Tablets, 1 mg
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Pharmacokinetic Characteristics of DP-R202 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is compare the safety and pharmacokinetic characteristics of
      DP-R202 (Sarpogrelate HCl 300mg, qd) with those of Anplag (Sarpogrelate HCl 100mg, tid) after
      oral administration in healthy male volunteers.
    

Detailed description: 
      The number of patient is thirthy-six.Patients were randomly assigned either anplag
      tablet(Sarpogrelate HCL 100mg, tid)first, DP-R202(Sarpogrelate HCL 300mg, qd) Second or
      DP-R202(Sarpogrelate HCL 300mg, qd) first, anplag tablet(Sarpogrelate HCL 100mg, tid) second.
    

Intervention name(s): Anplag
Intervention type(s): Drug
Intervention description(s): Sarpogrelate HCl 300mg once a day or 100mg three times a day
Other intervention name(s): DP-R202 : DP11002-2; Anplag : 0007
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Adipose-derived Stem Cells (ADSCs) for Moderate to Severe Chronic Kidney Disease
Condition: Moderate to Severe Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      1. To assess the safety of allogeneic injection of expanded ADSCs to patients with Moderate
           to Severe Chronic Kidney Disease

        2. To assess the efficacy of allogeneic injection of expanded ADSCs to patients with
           Moderate to Severe Chronic Kidney Disease
    


Intervention name(s): ELIXCYTE
Intervention type(s): Drug
Intervention description(s): Adipose-derived stem cells (ADSCs)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparisons of the Astigmatic Power of Toric Intraocular Lens Using Three Toric Calculators: AcrySof, TECNIS, and iTrace Toric Calculator
Condition: Cataract; Astigmatism
MeSH terms: Cataract; Astigmatism
Study type: Observational

Summary: 
      Purpose of this study is to compare the astigmatic power of the toric IOL obtained from the
      AcrySof toric calculator, TECNIS toric calculator, and iTrace toric calculator in a group of
      patients with preoperative with-the-rule (WTR) and against-the-rule (ATR) corneal
      astigmatism. The study included 100 eyes with cataract and greater than 0.75 diopter of
      corneal astigmatism, and the subjects were divided into WTR and ATR group. Keratometric value
      was measured using autokeratometry, IOLMaster partial coherence interferometry (PCI), iTrace
      incorporating corneal topography and ray-tracing aberrometry. Based on measured values, toric
      IOL power calculations were performed using AcrySof, TECNIS and iTrace toric calculators.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Subjects who planned to undergo cataract removal by phacoemulsification between January
        2013 to April 2013 at the Department of Ophthalmology, Yonsei University College of
        Medicine, Seoul, South Korea were included in this study.
      
Keywords: toric calculator; toric intraocular lens power; Acrysof; Tecnis; iTrace