bioihbjkbjnl/mcl2 huggingface dataset:
MRgFUS in the Treatment of Hand and Hip Osteoarthritic Pain
Condition: Osteoarthritis; Hip Osteoarthritis; Hand Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Study type: Interventional

Summary: 
      This project aims at performing a pilot study to provide data on safety and potential
      efficacy of Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS) in the treatment of
      pain caused by trapeziometacarpal osteoarthritis (OA) and/or scaphotrapezial OA, and by hip
      OA, while exploring the potential application of MRgFUS to two different and central joints
      burdened by OA.
    

Detailed description: 
      Pain caused by osteoarthritis is a matter of huge impact, in terms of quality of life, social
      and economic burden. Global aging of the population is going to worsen the problem. The hand
      is the most affected site in the upper limb, and involvement of the trapeziometacarpal joint
      is highly prevalent, with significant limitation of functionality when it happens. In the
      lower limb, the hip and the knee share the leading position in the clinical scenario, with
      the former being historically the most frequently submitted to joint replacement.

      At any site, the vast majority of joint replacement surgery procedures are performed because
      of pain. MRgFUS has recently demonstrated a great potential in treating pain caused by
      different medical conditions, including osteoarthritis. The aim of the work is to study the
      feasibility, the safety and the potential efficacy of MRgFUS in treating pain from
      osteoarthritis in two "hot" spots: the hip and the trapeziometacarpal/scaphotrapezial joint.
    

Intervention name(s): MRgFUS treatment; MRgFUS treatment
Intervention type(s): Device; Device
Intervention description(s): MRgFUS treatment of pain caused by trapeziometacarpal OA (and/or scaphotrapezial OA); MRgFUS treatment of pain caused by hip OA
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Pilot study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MRgFUS; Pain; Hip; Trapeziometacarpal joint; Osteoarthritis
Study of the Safety and Efficacy of MK-8521 Compared to Placebo and a Diabetes Drug in Participants With Type 2 Diabetes Mellitus (MK-8521-003)
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, efficacy, and pharmacokinetics of MK-8521 given once
      daily compared to placebo and another diabetes drug in participants with Type 2 diabetes
      mellitus (T2DM).

      This study was modified by a protocol amendment to a 2-part trial to further test the safety
      and tolerability of MK-8521 at higher doses and to compare MK-8521 pharmacokinetics between
      participants with T2DM and healthy participants. An additional cohort of T2DM participants
      and a cohort of non-diabetic obese participants has been added.
    


Intervention name(s): MK-8521; Liraglutide; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Follow-up Colonoscopy Examination in Patients Who Had Previously Undergone Screening Colonoscopy
Condition: Colonic Cancer
MeSH terms: Colonic Neoplasms
Study type: Observational

Summary: 
      -  To determine the prevalence of colonic neoplasm in patients who had previously undergone
           screening colonoscopy

        -  To determine the optimal time interval for re-screening in average risk individuals

        -  To determine potential baseline characteristics that predicts adenoma recurrence
    

Detailed description: 
      Colorectal cancer (CRC) is the second commonest cancer in Hong Kong, and tends to be
      increasing. Screening for colorectal cancer can reduce the cancer incidence and mortality by
      detecting early lesions. However, the best interval for a follow up colonoscopy, particularly
      for those with normal baseline colonoscopy, remains largely unknown.

      This study aim to determine the prevalence of colonic neoplasm in average-risk patients who
      had previously undergone screening colonoscopy and the optimal time interval for
      re-screening.
    

Intervention name(s): colonoscopy
Intervention type(s): Procedure
Intervention description(s): proform a follow up colonoscopy in the 5 year period from index colonoscopy
Other intervention name(s): follow up colonoscopy
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects who are previously participated in one of our two screening colonoscopy studies
        [Sung, Gastroenterol 2003; Leung, AJG 2004]
      
Keywords: colonic adenoma, colonic advanced neoplasm
Comparing Local Anesthetics for TAP Block During Abdominally-based Free Flap for Breast Reconstruction
Condition: Breast Reconstruction; Anesthesia; Transverse Abdominis Plane Block
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will compare the efficiency of transversus abominus plane (TAP) block using
      liposomal bupivacaine versus plain bupivacaine that is administered in the operating room
      under ultrasound guidance prior to the in patients undergoing abdominally-based free flap
      breast reconstruction at Vanderbilt University Medical Center.
    

Detailed description: 
      Transversus Abdominis Plane (TAP) blocks are commonly used as part of Enhanced Recovery After
      Surgery (ERAS) pathway. This prospective, double-blinded, randomized control trial compares
      post-operative pain and narcotic consumption after deep inferior epigastric artery perforator
      (DIEP) breast reconstruction with liposomal bupivacaine (LB) compared to bupivacaine
      hydrochloride (BHCl). Subjects undergoing DIEP flaps were randomly assigned LB or BHCl,
      performed using ultrasound-guided TAP block technique pre-procedurally. Primary outcomes were
      postoperative narcotic analgesia required in oral morphine equivalents (OME) from
      postoperative day (POD) 0 to 7. Secondary outcomes included POD 1-7 pain Numeric Rating Scale
      (NRS), non-narcotic pain medication consumption, time to first narcotic use, return of bowel
      function, and length of stay (LOS).
    

Intervention name(s): Liposomal bupivacaine; Regular bupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.; 20mL of 0.25% bupivacaine injected on each side.
Other intervention name(s): LB; Bupivacaine HCl
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
The Effectiveness of Electroacupuncture and Standard Therapy Compared to Standard Therapy in Gynecological Cancer Pain
Condition: Gynecologic Cancer; Cancer Related Pain; Cancer Pain
MeSH terms: Cancer Pain
Study type: Interventional

Summary: 
      Gynecological cancer is cancer that starts in the female reproductive organs. Pain in
      gynecological cancer can be caused by an underlying malignancy or surgical procedure as well
      as chronic pain associated with malignancy and sequelae of the therapy given. Gynecological
      cancer patients often experience moderate to severe pain and use higher levels of opioids
      than patients diagnosed with other cancers. More than two thirds of patients with advanced
      cancer experience severe pain and up to half of these patients report that their pain is not
      well controlled. This study aims to analyze the effectiveness of electroacupuncture plus
      standard therapy on pain intensity (VAS score), changes in analgesic dose, and quality of
      life (QLQ C-30 EORTC score) in patients with gynecological cancer pain compared to standard
      therapy alone.
    

Detailed description: 
      This study was conducted using single blinded randomized control clinical trial, design in 58
      patients diagnosed with gynecological cancer, aged 18 to 65 years, who experienced cancer
      pain, with VAS ≥ 4, pain caused by a tumor, before or while undergoing a therapeutic process
      (radiation therapy, chemotherapy, or post surgery), side effects or due to the toxicity of
      cancer treatment, willing to take part in this study and sign informed consent who were
      randomized into 2 groups, namely group I electroacupuncture with standard therapy and group 2
      standard therapy, the acupuncture points used were LI4, PC6, ST36, SP6 and LR3, after the
      acupuncture needle was inserted, the needle was connected to the electrosimulator. The
      outputs assessed were pain intensity using the VAS, changes in analgesic dose, and quality of
      life with the EORTC QLQ C-30 questionnaire, which was assessed on the day before starting
      therapy, the first day, the second day, the third day, the fifth day and the seventh day.
    

Intervention name(s): Electroacupuncture
Intervention type(s): Other
Intervention description(s): Patient receive analgetic medicine will get experimental procedure with needle insertion that attach to eletrostimulator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Electroacupuncture; Cancer pain; Gynecological cancer pain; Acupuncture; VAS; EORTC QLQ C 30; Quality of Life; Analgetic Dose
Altitude Sickness Prevention With Ibuprofen Relative to Acetazolamide and Treatment Efficacy
Condition: Acute Mountain Sickness
MeSH terms: Altitude Sickness
Study type: Interventional
Phase: Phase 1

Summary: 
      This double blind randomized trial will compare ibuprofen to acetazolamide for the prevention
      of acute mountain sickness. These drugs have never been directly compared for efficacy. The
      study population is hikers who are ascending at their own rate under their own power in a
      true hiking environment at the White Mountain Research Station, Owen Valley Lab (OVL) and
      Bancroft Station (BAR), Bancroft Peak, White Mountain, California.
    

Detailed description: 
      The specific aim of this study is to evaluate if acetazolamide will be similar to ibuprofen
      (i.e. Ibuprofen being non-inferior) in decreasing the incidence of Acute Mountain Sickness
      (AMS) in travelers to high altitude. It has been shown that ibuprofen taken 3 times a day 6
      hours prior to ascent is effective for the prevention of AMS, with a number needed to treat
      of 4, decreasing the odds of getting AMS by a third. The efficacy appears to be similar to
      acetazolamide, with a NNT of 3 -8, although these two medications have not been directly
      compared in prevention of AMS. Acetazolamide is diuretic that is the only FDA approved AMS
      prophylactic medication and the most commonly used drug for AMS prevention. Although
      acetazolamide has been given a 1A indication, it has been shown to limit exercise
      capabilities at high altitude, and rapid ascent has been shown to attenuate its protective
      effects. Ibuprofen has been given a IIB recommendation by the Wilderness Medical Society
      Practice Guidelines, in part because it has not directly compared to acetazolamide. It is
      unknown if a non-steroidal anti-inflammatory can provide protection from AMS equivalent to
      acetazolamide.
    

Intervention name(s): Ibuprofen; Acetazolamide
Intervention type(s): Drug; Drug
Intervention description(s): non-steroidal anti-inflammatory drug; a diuretic
Other intervention name(s): Motrin; diamox
Intervention MeSH terms: Ibuprofen; Acetazolamide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized double blind controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
The Drug-drug Interaction of SHR3824 and Metformin
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to investigate the potential interaction between multiple oral
      doses of SHR3824 and a single oral dose of metformin in healthy adult volunteers.
    

Detailed description: 
      This is an open-label (volunteers will know the names of treatments they are assigned)
      single-center study of SHR3824 and metformin in healthy adult volunteers. SHR3824(a
      Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood sugar
      levels in patients with type 2 diabetes mellitus (T2DM) and metformin is an approved
      treatment for patients with T2DM. SHR3824 will be administered orally (by mouth) as 25 mg on
      Days 4, 5, 6, 7, and 8 and metformin will be administered orally as two 500mg tablets on Days
      1 and 8. Both SHR3824 and metformin tablets will be taken with 8 ounces (240 mL) of water.
    

Intervention name(s): SHR3824 metformin
Intervention type(s): Drug
Intervention description(s): Two 500-mg tablets of metformin on Day 1 followed by 25 mg of SHR3824 once daily on Days 4 through 8 followed by two 500-mg tablets of metformin and 25 mg of SHR3824 on Day 8.
Drug: SHR3824 + Metformin
Other intervention name(s): Henagliflozin metformin
Intervention MeSH terms: Metformin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SHR3824 metformin drug-drug interaction
Neuroimaging Studies of Chronic Primary Headaches Using Positron Emission Tomography and Magnetic Resonance Imaging
Condition: Migraine; Chronic Migraine
MeSH terms: Migraine Disorders; Headache
Study type: Observational

Summary: 
      Investigators hypothesize that chronic primary headaches are accompanied by a discrete
      pattern of brain metabolism and activity involving brain structures related to the
      development of acute exacerbations as well as pain modulation. Such structures include the
      brainstem, hypothalamus, and orbitofrontal cortex and can be defined using functional brain
      imaging.
    

Detailed description: 
      Specific aims of the study include:

        1. To determine the pattern of brain metabolism using positron emission tomography (PET)
           found in chronic migraine, episodic migraine and control patients.

        2. To determine changes of resting state brain networks using magnetic resonance imaging
           (MRI) between patients with chronic or episodic headache and healthy volunteers.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with episodic migraine, chronic migraine and control patients. Definitions are
        taken for the International Classification of Headache Disorders-2nd Edition (see
        references).
      
Keywords: Episodic migraine; Chronic migraine; Magnetic resonance imaging; Positron emission tomography
Positive Pressure Ventilation Through a Laryngeal Mask Airway in Pediatrics
Condition: Pediatric; Anesthesia
Study type: Interventional

Summary: 
      The investigators aimed to investigate effects of intubation and laryngeal mask airway usage
      in pediatrics during laparoscopic inguinal hernia repair.
    

Detailed description: 
      Considering blood gas analysis, end tidal carbon dioxide measurements and airway changes, the
      investigators aimed to investigate effects of intubation and laryngeal mask airway usage in
      pediatrics during laparoscopic inguinal hernia repair in this study.
    

Intervention name(s): Orotracheally intubation; Laryngeal Mask Airway
Intervention type(s): Device; Device
Intervention description(s): Interventions used for airway safety and ventilation during surgical procedures; Interventions used for airway safety and ventilation during surgical procedures
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All pediatric patients, who were scheduled to undergo laparoscopic surgery
Masking: None (Open Label)
Primary purpose: Treatment
A Randomized, Controlled Study to Evaluate Efficacy and Safety of Intra-articular Ampion for Osteoarthritis Pain in Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy of an Intra-Articular Injection of Ampion™ in Adults
      with pain due to osteoarthritis of the knee.
    

Detailed description: 
      A Randomized, Placebo-controlled, Double-Blind Study to Evaluate the Efficacy and Safety of
      an Intra-Articular Injection of Ampion™ in Adults with pain due to osteoarthritis of the
      knee.

      The primary study objective was to evaluate the efficacy of 4 mL Ampion versus 4 mL saline
      intra-articular (IA) injection in treating knee pain when administered to subjects suffering
      from osteoarthritis (OA) of the knee (OAK).

      The secondary study objectives included evaluation of the safety of an IA injection of Ampion
      vs saline, efficacy of IA injection of Ampion vs saline in improving knee function.
    

Intervention name(s): 4 mL injection of Ampion; 4 mL Injection of Placebo
Intervention type(s): Biological; Drug
Intervention description(s): 4 mL injection of Ampion; 4 mL Injection of Placebo
Other intervention name(s): Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Osteoarthritis; osteoarthritis of the knee
Peer Leadership for Physical Literacy
Condition: Leadership; Physical Activity
Study type: Interventional

Summary: 
      The purpose of the proposed research is to develop, implement, and test the efficacy of a
      theory-driven evidence-based peer leadership program for elementary school students (Grade
      6/7; age 11/12 years) in relation to (a) their own leadership skills and their leadership
      self-efficacy (i.e., confidence to lead), as well as (b) the physical literacy of younger
      (Grade 3/4; age 8/9) students with whom they are partnered.
    


Intervention name(s): Leadership Intervention
Intervention type(s): Behavioral
Intervention description(s): Grade 6/7 teachers will take part in a workshop on developing transformational leadership among their Grade 6/7 students, and provide teachers with a 4-week training program. Teachers will implement a 4-week leadership development component to their Grade 6/7 students. Grade 6/7 students will then deliver a 10-week peer-led FMS program to Grade 3/4 students. The Grade 6/7 peer leaders will lead 2 x 30 min sessions per week during physical education classes, recess, or lunch times. In weeks two and three, peer leaders will be observed by members of the research team and provided with feedback using a structured checklist regarding their delivery in the session. Mid-way through the 10-week program teachers will deliver a booster leadership training component to the Grade 6/7 peer-leaders.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: school; intervention; physical literacy; peer mentor; leadership; motor skills; physical activity
Study of the Efficacy and Safety of Initial Administration of 17 mg Vortioxetine Intravenously With 10 mg/Day Vortioxetine Orally in Patients With Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the early onset of efficacy of vortioxetine 17 mg intravenously (IV) and
      vortioxetine 10 mg/day oral dose regimen versus placebo IV and vortioxetine 10 mg/day oral
      dose regimen on depressive symptoms
    


Intervention name(s): Vortioxetine (IV); Placebo (IV); Vortioxetine (tablet)
Intervention type(s): Drug; Other; Drug
Intervention description(s): 17 mg, solution for infusion, administered, over 2 hours as single dose; Saline: isotonic sodium chloride, administered, over 2 hours as single dose; 10 mg, tablets, oral administration once daily for 15 days (open labelled)
Intervention MeSH terms: Vortioxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Treatment Patterns in Castrate Resistant Prostate Cancer Patients With Bone Metastases in a Medicare Population
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms; Neoplasm Metastasis
Study type: Observational

Summary: 
      The goal of the study is to provide a detailed description of treatments for CRPC (Castrate
      Resistant Prostate Cancer) patients with bone metastases and the resource utilization and
      costs associated with that diagnosis and subsequent treatments.
    


Intervention name(s): Radium-223 dichloride (Xofigo, BAY88-8223)
Intervention type(s): Drug
Intervention description(s): Therapies used to treat prostate cancer and more specifically castrate resistant prostate cancer inclusively Xofigo (Radium-223 dichloride, BAY88-8223)
Intervention MeSH terms: Radium Ra 223 dichloride
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Castrated resistant prostate cancer patients with bone metastases
      
Keywords: Castrated resistant prostate cancer; Patients with bone metastases
Drug-drug Interactions Between AZD4205 and Itraconazole/Carbamazepine
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single-center, nonrandomized, open-label, 2-part, fixed-sequence,
      drug-drug interaction (DDI) study to assess the effect of multiple doses of itraconazole, a
      CYP3A4 enzyme inhibitor, on the single dose PK of AZD4205 in healthy adult subjects (Part A)
      and to assess the effect of multiple doses of carbamazepine, a CYP3A4 inducer, on the single
      dose PK of AZD4205 in healthy adult subjects (Part B).
    


Intervention name(s): AZD4205 and carbamazepine; AZD4205 and itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): All subjects will receive AZD4205 single dose on Day 1, and the second dose of AZD4205 along with carbamazepine after the wash-out period.; All subjects will receive AZD4205 single dose on Day 1, and the second dose of AZD4205 along with itraconazole after the wash-out period.
Intervention MeSH terms: Itraconazole; Carbamazepine
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Anti-pollution Effects of AP Green Tea Extracts
Condition: Respiratory Conditions Due to Unspecified External Agent
Study type: Interventional

Summary: 
      The objective of this clinical trial is to evaluate the anti-pollution effects of AP green
      tea extracts in subjects with discomforts related to the respiratory system by prolonged
      exposure to particulate matter in air pollution
    


Intervention name(s): AP green tea extracts
Intervention type(s): Dietary Supplement
Intervention description(s): AP green tea extracts
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Anti-pollution; green tea extracts