bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness and Cost-effectiveness of Doin (Conduction Exercise) for Chronic Neck Pain
Condition: Chronic Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      A pilot multicenter randomized controlled trial will be conducted to evaluate the clinical
      effectiveness, cost-effectiveness, and safety of Doin (conduction exercise) with acupuncture
      for chronic neck pain patients compared to acupuncture alone.
    

Detailed description: 
      A pilot multicenter randomized controlled, parallel, assessor-blinded trial will be conducted
      to evaluate the comparative clinical effectiveness and cost-effectiveness of Doin (conduction
      exercise) with acupuncture for chronic neck pain patients with acupuncture alone as assessed
      by pain and functional disability scales, monitor its safety, and assess the feasibility of
      and serve as the basis for a full-scale, multicenter trial.
    

Intervention name(s): Doin (conduction exercise); Acupuncture
Intervention type(s): Procedure; Device
Intervention description(s): Doin (conduction exercise) will be combined with acupuncture as active and passive movement to the aim of effective treatment of pain and functional disability. Doin (conduction exercise) sessions will be conducted 2 times a week for 5 weeks.; Acupuncture will be performed with manual stimulation (needle twirling) to evoke de-qi sensation. Acupuncture sessions will be conducted 2 times a week for 5 weeks.
Other intervention name(s): Doin Exercise; Do-in Exercise; Conduction Exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neck Pain; Disability Evaluation; Costs and Cost Analysis; Doin Exercise Therapy; Acupuncture
Intravenous Fluids in Hospitalised Children
Condition: Hypokalemia; Hyponatremia; Hypernatremia; Dehydration
MeSH terms: Hyponatremia; Dehydration; Hypernatremia; Hypokalemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The main objective of the trial is to evaluate the risk of hypokalemia following
      administration of a isotonic solution compared to a hypotonic solution in acutely ill
      hospitalised children, who need intravenous fluid therapy.
    

Detailed description: 
      The main objective of the trial is to evaluate the risk of hypokalemia (low plasma potassium
      concentration) following administration of a Plasmalyte Glucos 50 mg/mL solution compared to
      a 0.45% saline in 5% dextrose solution in acutely ill hospitalised children, who need
      intravenous fluid therapy. The secondary objective of the trial is to evaluate the risk of
      hyponatremia (low plasma sodium concentration) and the risk of hypernatremia (high plasma
      sodium concentration) following administration of isotonic solution compared to hypotonic
      solution.
    

Intervention name(s): Plasmalyte Glucos 50 mg/mL; 0.45% saline in 5% dextrose
Intervention type(s): Drug; Drug
Intervention description(s): Solution contains potassium chloride 5 mmol/L and sodium chloride 140 mmol/L.; Solution contains potassium chloride 20 mmol/L and sodium chloride 80 mmol/L.
Other intervention name(s): ATC-code: B05BB02; 0.45% NaCl in 5% dextrose.
Intervention MeSH terms: Plasma-lyte 148
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Isotonic; Hypotonic; Intravenous fluids
Retaane® in Age-Related Macular Degeneration
Condition: Age Related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The treatment of fibrotic choroidal neovascular lesions with presence of residual peripheral
      activity in age related macular degeneration currently presents a great challenge. With
      visual loss threatening, there are only very few therapeutic options.

      While these patients are neither suitable for laser therapy nor for photodynamic therapy with
      Verteporfin, antiangiogenic drugs applied intravitreally are now available.

      Some patients however reject this therapeutic option because of potential complications such
      as endophthalmitis and the frequency of necessary injections. 20 patients who rejected
      intravitreal therapy were treated with Anecortave acetate (Retaane®) which was applied as a
      juxtascleral depot injection.
    


Intervention name(s): juxtascleral depot injection of Retaane
Intervention type(s): Drug
Intervention description(s): juxtascleral depot injection of Retaane
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Using Regular or Rotary Polypectomy Snare for the Resection of Colorectal Polyps
Condition: Polypectomy Snare
Study type: Interventional

Summary: 
      This clinical trial is being conducted to assess whether the rotary polypectomy snare could
      decrease the time to removal of colorectal polyps
    


Intervention name(s): Disposable Polypectomy Snare,JHY-SD-23-230-30-A1
Intervention type(s): Device
Intervention description(s): The technique is hot snare resection of the polyp with electrocautery. Details are as follows: (1) insert the snare into the colonoscopy; (2) connect the snare with the high-frequency device;(3) advance sliding handle to open the loop; (4) adjust the direction of the snare by rotating the handle as required, rotate the loop until the loop reaches target polyp; (6) encircle the target polyp with loop; (7) pull the sliding handle, lasso the target polyp;(8) resect the polyp with electrocautery, then inhaling the transected polyp into a trap followed by submission to the histological evaluation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Three Dimensional Morphology of Upper Respiratory Tract and Mandibular Position on Obstructive Sleep Apnea
Condition: Sleep Apnea, Obstructive
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      Oral appliances, which can maintain patients' jaw forwards during sleep, become more popular
      in treating obstructive sleep apnea (OSA). However, the exact mechanism of mandible forward
      on upper airway is not completely known. In this study we will use both static and dynamic
      MRI to study the 3D morphological changes and dynamic behavior of the upper respiratory tract
      at different mandible posits. Because in asian society non-obese OSA patients are not
      uncommonly seen, in this study we focus only on non-obese severe OSA patients.
    

Detailed description: 
      The aim of this study is to analyze upper airway morphology changes and dynamic movement at
      different sections affected by mandible position by using dynamic and static magnet resonance
      imaging technique. The study also discusses the formation mechanism of obstructive sleep
      apnea syndromes and function mechanism of the oral appliance, as well as the evaluation of
      the clinical results of the oral appliance on non-obese male patients with severe obstructive
      sleep apnea in Taiwan.

      10 non-obese (BMI<25) severe OSA (AHI>30) male patients between the age of 20 to 60 and 10
      gender, BMI and age matched control (AHI<5) were recruited for this study. Nine bite index
      were made for the different mandible positions of the subjects.

      Upper airway was imaged by using static and dynamic MRI of each subject wearing the bite
      index while lying on the MRI scanning table. This study also measures the circumference and
      takes the lateral cephalometric imaging of each subject. Oral appliances were made and fitted
      for the experimental group subjects, who wore them for three months, after which they
      transferred to the Sleep Center and underwent PSG examination to evaluate therapeutic effects
      of the appliances.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients referred from sleep center
Insulin Glargine Plus Insulin Glulisine Multiple Daily Injections (MDI) Versus Premix Insulin Treatment in Subjects With Diabetes Mellitus (Type 1 or Type 2)
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test for superiority in improvements from baseline in patient
      reported outcomes in subjects with type 1 or type 2 diabetes when treated with insulin
      glargine plus rapid acting insulin glulisine MDI versus treatment with premix insulin.
    


Intervention name(s): insulin glargine; insulin glulisine
Intervention type(s): Drug; Drug
Intervention description(s): Sequence 1 (Lantus + Apidra first, then Premix): Subjects randomized to this sequence will receive ApidraTM administered three times per day 0-15 minutes before main meals using a fixed bolus regimen following titration based on preprandial blood glucose values; as well as Lantus qd for 12 weeks. After the first 12 weeks, subjects will cross over to the premix insulin for a further treatment of 12 weeks.; Sequence 2 (Premix first, then Lantus + Apidra): Subjects randomized to this sequence will receive premix insulin (either Humalog Mix 75/25 or Novolog Mix 70/30, depending on which insulin they were taking at entry into the study) once or twice per day for 12 weeks. After the first 12 weeks, subjects will cross over to the Lantus plus Apidra sequence for a further treatment of 12 weeks.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin glulisine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 2
From Innovation to Solutions: Childhood Influenza Vaccination Planning
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      The purpose of this study is to increase childhood influenza vaccination rates using the FDA
      licensed influenza vaccines according to national guidelines in a randomized cluster trial in
      which primary care offices are randomized to intervention or control with the control group
      receiving the intervention in the second year.
    

Detailed description: 
      The investigators will conduct a stratified, randomized cluster trial of 20 diverse primary
      care practices to compare influenza vaccination rates in intervention and control sites.
      Intervention sites will use a package of newly developed and evidence-based techniques that
      will be tailored to their practice structure and culture, called the 4 Pillars Immunization
      Toolkit, in addition to receiving donated vaccine for early season vaccination. Control
      practices will not receive such assistance but will receive the intervention in the second
      year.
    

Intervention name(s): 4 Pillars Immunization Toolkit
Intervention type(s): Behavioral
Intervention description(s): Pillar 1: Convenient Vaccination Services; Pillar 2: Patient notification about the importance of vaccination and availability of convenient services; Pillar 3: Enhanced Office Systems; Pillar 4: Motivation: Office immunization champion tracks progress towards a goal; Early delivery of donated vaccines for disadvantaged children, staff education, support of effort by research staff.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: influenza; vaccination; strategies; children/adolescents
Bioequivalence Between Two Oral Formulations of Diphenhydramine Hydrochloride
Condition: Nasal Congestion
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if two formulations of diphenhydramine
      hydrochloride are bioequivalent.
    

Detailed description: 
      Subjects were required to observe a ten-hour fast and a one-hour fluid restriction prior to
      each dosing period.

      Subjects were randomized into one of two active treatment groups, received supervised dosing
      of their treatment with approximately eight ounces of water, and were required to maintain
      fluid restriction for one hour after treatment. Following the one-hour post-dose fluid
      restriction, subjects could drink water, but consumer no other food or fluids for four hours
      post-dose.

      Following a seven-day washout period, the comparison treatment was administered according to
      the same procedure as above.
    

Intervention name(s): Diphenhydramine hydrochloride
Intervention type(s): Drug
Intervention description(s): After a ten-hour fast and a one-hour fluid restriction prior to each dosing period, subjects received supervised dosing of their first 25 mg treatment with approximately eight ounces of water. Following a seven-day washout, the comparison treatment was administered according to thye same procedure.
Other intervention name(s): Benadryl Allergy; 25 mg KAPSEALS capsule; 25 mg ULTRATAB tablets
Intervention MeSH terms: Diphenhydramine; Promethazine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bioequivalence, diphenhydramine hydrochloride
Ultra-wide Diameter Implants in Mandibular Molars
Condition: Dental Implants
Study type: Interventional

Summary: 
      The goal of this [clinical trial] is to [To evaluate both the clinical and radiographical
      outcome on osteointegration and peri-implant bone density when using ultra wide diameter
      implant placed immediately in molar extraction socket]
    

Detailed description: 
      the aim of this study is to evaluate the clinical and radiographical outcomes on
      osseointegration and peri-implant bone density when using 12 ultrawide diameter dental
      implants placed immediately in 12 patients after atraumatic extraction of non-restorable
      mandibular molars without raising a flap or using bone grafts.
    

Intervention name(s): Immediate implant placement of Ultrawide diameter dental implants
Intervention type(s): Procedure
Intervention description(s): immediate placement of ultrawide diameter dental implants in a fresh extraction socket of mandibular molar teeth
Other intervention name(s): Ultrawide diameter dental implants
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: UWD implants
A Prospective Study to Evaluate Clinical Performance of Thermalytix in Detecting Breast Cancers
Condition: Breast Cancer; Early Detection of Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to determine the clinical performance of AI-based Thermalytix
      with the current standard-of-care diagnostic modalities in women.
    

Detailed description: 
      While mammography is the most accepted breast cancer screening test, it is less sensitive in
      women with dense breast tissue, who have a four fold high risk for developing breast cancer.
      Thermalytix is a novel automated breast cancer screening solution that uses artificial
      intelligence (AI) over thermal images to detect and localise breast cancer lesions in women.
      In this study the performance of Thermalytix over mammography is evaluated in women with
      dense and non-dense breast tissue who presented for a health check-up at a hospital. All
      women underwent Thermalytix and mammography, and participants who were reported as positive
      on either test were recommended for further investigations. Sensitivity, specificity,
      positive predictive value, and negative predictive value were calculated across age-groups,
      menopausal status, and breast densities against the current standard-of-care diagnostic
      modalities.
    

Intervention name(s): Thermalytix
Intervention type(s): Diagnostic Test
Intervention description(s): Thermalytix is an Artificial intelligence based automated breast screening solution that analyzes thermal distribution on the breast to generate a breast health score automatically. Thermal imaging was performed by a trained technician to capture thermal images of the participant in five views. These thermal images were uploaded to Thermalytix software on the cloud where it was automatically analyzed by AI-based Thermalytix computer-aided detection (CADe) engine. This CADe engine analyzes uploaded thermal images and outputs an interpretation report for each participant with quantitative scores corresponding to computed probability of malignancy based on the structural, vascular, areolar, thermal properties of the observed abnormality. Thermalytix also generates annotated images with markings of abnormal regions and an overall Thermalytix score suggesting likelihood of breast malignancy. The locked AI model Thermalytix algorithm version 3, dated December 2018 was used for the analysis.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women who came in for a breast mammography at Max Super Speciality Hospital, Saket were
        invited to take part in the study.
      
Keywords: Breast cancer; Thermography; Thermalytix; Artificial Intelligence; Machine Learning; Dense Breasts; Breast Density; Mammography; Breast Cancer Screening
Optimizing Outpatient Anesthesia (OSPREy-Outpatient Surgery Pain Relief Enhancement)
Condition: Opioid Use; Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The overall goal of this research is to improve perioperative pain treatment, decrease
      post-operative opioid consumption, diminish opioid related side effects, and reduce postop
      opioid prescribing (and hence opportunity for diversion, abuse, addiction, and fatal
      overdose).
    

Detailed description: 
      This protocol will test the innovative, paradigm-shifting hypothesis that anesthesia for
      outpatient surgery with long-duration opioids (methadone), compared with conventional
      short-duration opioids, achieves better analgesia, with similar or diminished side effects,
      may reduce development of chronic postsurgical pain, improves recovery, and importantly,
      decreases postoperative opioid consumption and could hence diminish take-home opioid
      prescribing and shrink the population reservoir of unused opioids available for diversion and
      misuse. Two cohorts will be studied, but analyzed separately. 1) Short-stay, anticipated
      next-day discharge surgery (compare short-duration vs long-duration opioid), 2) Same-day
      discharge surgery (compare short-duration vs long-duration opioid).
    

Intervention name(s): Methadone; Fentanyl; Hydromorphone; Morphine; Sufentanil
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.; Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).; Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).; Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).; Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).
Intervention MeSH terms: Fentanyl; Sufentanil; Morphine; Methadone; Hydromorphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Safety, Tolerability and Pharmacodynamics Evaluation of CBT-009 Eye Drop
Condition: Myopia, Progressive
MeSH terms: Myopia, Degenerative
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a Two-Stage Phase 1/2 study to evaluate the safety, tolerability and pharmacodynamics
      of CBT-009 eye drop in healthy volunteers.

      CBT-009 has the active ingredient of atropine, which at low doses, has shown to be effective
      in slowing down myopic deterioration. Current atropine products are prone to degradation once
      the container is open to the air. ADS Pharmaceutical has developed a novel atropine
      formulation.
    

Detailed description: 
      Type of Study:

      Stage 1: Single center, open-labeled, vehicle-controlled, single ascending dose.

      Stage 2: Parallel, double-masked, randomized, vehicle-controlled with dosing once-daily in
      one eye.

      Study Population:

      Male or female healthy volunteers aged 18-36 years.

      Number of Subjects and Sites:

      Stage 1: Enrollment is planned for approximately 32 healthy volunteers with 8 subjects per
      cohort for a total of 4 cohorts.

      Stage 2: Enrollment is planned for approximately 50 healthy volunteers with 25 subjects per
      cohort for a total of 2 cohorts.

      Duration of Study Participation:

      Stage 1: One day. Stage 2: 28 days of treatment with no follow-up observations.
    

Intervention name(s): CBT-009; Vehicle; Atropine Sulfate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): This is a Two-Stage Phase 1/2 study to evaluate the safety, tolerability and pharmacodynamics of CBT-009 eye drop in healthy volunteers.; This is a Two-Stage Phase 1/2 study to evaluate the safety, tolerability and pharmacodynamics of CBT-009 eye drop in healthy volunteers.; This is a Two-Stage Phase 1/2 study to evaluate the safety, tolerability and pharmacodynamics of CBT-009 eye drop in healthy volunteers.
Other intervention name(s): Atropine; Without Atropine; 0.025% eyedrop aqueous solution
Intervention MeSH terms: Atropine
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Aromatase inhibition versus estradiol during 1 week
    


Intervention name(s): Aromatase inhibition; Estradiol
Intervention type(s): Drug; Drug
Intervention description(s): Letrozole; Dermestril
Intervention MeSH terms: Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Physiology; males