bioihbjkbjnl/mcl2 huggingface dataset:
Acupuncture in Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study was to evalute three different acupuncture techniques, including one
      sham control, in its effect on osteoarthitis of the knee
    

Detailed description: 
      Background: Acupuncture is one of the most frequently used complementary therapeutic
      approaches in the treatment of osteoarthritis of the knee. Due to methodological shortcomings
      of previous randomized controlled studies, controversy persists whether the observed effects
      are specific to acupuncture or non-specific consequences of needling.

      Objective: To compare classical Chinese acupuncture, semi-standardized modern acupuncture and
      non-specific needling by means of a double-blinded repeated measures cross-over design.

      Intervention: Within three weeks all patients receive three treatment modalities in a random
      order in a double-blind study design.

      Main outcome measures: Improvement in knee flexibility according to the neutral-zero method,
      defining a success as improvement by 10 degrees or more.

      Secondary parameter: improvement in pain according to the reduced WOMAC score by 50 percent
      or more.
    

Intervention name(s): Acupuncture
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: acupuncture; double-blind; sham control; osteoarthritis; pain
Controlled Hypotension During Functional Endoscopic Sinus Surgery
Condition: Hemorrhage
MeSH terms: Hypotension; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      It is very important to decrease the bleeding during functional endoscopic sinus surgery
      (FESS) in order to increase the visibility of the surgical site. Our primary goal was to
      investigate the effects of magnesium sulfate and dexmedetomidine used for controlled
      hypotension on visibility of surgical site.
    

Detailed description: 
      Background: It is very important to decrease the bleeding during functional endoscopic sinus
      surgery (FESS) in order to increase the visibility of the surgical site. Our primary goal was
      to investigate the effects of magnesium sulfate and dexmedetomidine used for controlled
      hypotension on visibility of surgical site.

      Methods: Sixty patients aged between 18-65 years were enrolled. Patients were divided into
      two groups. In the magnesium sulfate group (Group M) patients were administered 40 kg-1
      magnesium sulfate in 100 ml saline solution in 10 minutes as IV loading dose 10 minutes
      before the induction and 10-15 mgkg-1hour-1 infusion during the surgery. In the
      dexmedetomidine group (Group D) patients were administered 1 µgkg-1 dexmedetomidine in 100 ml
      saline solution as loading dose 10 minutes before the surgery and 0.5-1 µgkg-1hour-1
      dexmedetomidine during the surgery. Deliberate hypotension was defined as a mean arterial
      pressure (MAP) being 60-70 mmHg.
    

Intervention name(s): Magnesium Sulfate; Dexmedetomidine
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg kg-1 IV magnesium sulfate (OSEL ilaç San. Ve Tic. A.Ş., Beykoz, Istanbul, Turkey) in 100 ml saline solution was applied to patients in Group M as a loading dose 10 minutes before the induction and continued during the surgery at the dose of 10-15 mg kg-1hour-1.; 1 µg kg-1 IV dexmedetomidine (Precedex Abbott Labs, North Chicago, IL) in 100 ml saline solution was applied to patients in group D 10 minutes before the surgery and continued during the surgery at the dose of 0.5-1 µg kg-1.
Other intervention name(s): Precedex
Intervention MeSH terms: Magnesium Sulfate; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: controlled hypotension, dexmedetomidine, magnesium sulfate.
The Effect of Periodontal Treatment and the Use of Dentifrice on Glycaemic Control in Diabetics
Condition: Periodontal Disease
MeSH terms: Periodontal Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      To test effectiveness of dentifrice in maintaining periodontal health.
    


Intervention name(s): Triclosan, Fluoride; Fluoride
Intervention type(s): Drug; Drug
Intervention description(s): subjects brushed their teeth twice daily with the study toothpaste for the assigned treatment period.; subjects brushed their teeth twice daily with the study toothpaste for the assigned study treatment period.
Other intervention name(s): triclosan/fluoride/copolymer toothpaste; current marketed fluoride only toothpaste
Intervention MeSH terms: Triclosan; Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Preservation of Fat Free Mass During Weight Loss
Condition: Muscle Loss
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      In this study, we aimed to examine the effect of whey protein supplementation given before
      night sleep on Fat Free Mass (FFM) preservation during a 4 wk period on Very Low Caloric Diet
      (VLCD).

      Half of the participants underwent a 4 week VLCD and walking program, while the other half
      underwent a 4 week VLCD, walking program and had an additional protein supplement before each
      night sleep.
    


Intervention name(s): Whey protein supplementation; walking program; Very Low Calorie Diet
Intervention type(s): Dietary Supplement; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized single blinded, controlled intervention trial
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: FFM; VLCD; exercise; Protein; Obesity
the New Biomarker of the Knee Osteoarthritis Knee Osteoarthritis Occurrence and Progression
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational [Patient Registry]

Summary: 
      It was previously proved an association of TGF-β1 and PDGF-BB with the pathogenesis of
      osteoarthritis (OA) by experiments of OA animal models. In this study, we aimed to determine
      whether serum concentrations of TGF-β1, PDGF-BB and CTX-1 were related to the knee OA. knee
      OA cases were collected from the first affiliated hospital of Shihezi university and healthy
      controls were recruited from the community. The severity of knee OA was defined as
      kellgren-lawrence (K-L) classification criteria.Serum levels of chemical biomarkers were
      compared between knee OA cases and controls or among K-L grade 2 to grade 4 groups. The serum
      concentrations of the TGF-β1, PDGF-BB and CTX-1 were determined by ELISA .
    


Intervention name(s): x-ray images
Intervention type(s): Radiation
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        210 patients diagnosed with knee OA in clinics were found in hospital patients .

        Healthy controls were recruited from community questionnaires in Shihezi city, Xinjiang
        province, China.
      
Keywords: Biomarkers
A Study of Omarigliptin (MK-3102) in Participants With Impaired Renal Function (MK-3102-009)
Condition: Chronic Renal Insufficiency; Type 2 Diabetes Mellitus
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 2-part study in participants with renal impairment and matched healthy participants
      to investigate the effect of impaired renal function on the plasma and urine levels of
      omarigliptin (MK-3102) after taking a single 3 mg dose by mouth.
    

Detailed description: 
      In Part I, three panels of 6 participants each will be enrolled with varying degrees of renal
      disease (mild, moderate, or severe renal impairment) based on their estimated glomerular
      filtration rate (eGFR). Each of these panels will be matched with a corresponding panel of
      equal number of healthy, age-, race-, BMI- and gender-matched control participants. All
      panels will receive a single oral dose of 3-mg omarigliptin, followed by plasma sampling and
      urine collection. In Part II, 6 participants with end stage renal disease (ESRD) requiring
      hemodialysis will receive a single 3-mg oral dose of omarigliptin immediately following
      hemodialysis (HD) (Period 1) and 2 hours prior to HD (Period 2).There will be approximately 1
      month between Period 1 and Period 2. A corresponding panel of equal number, healthy matched
      control subjects (age, race, BMI, gender) will also receive a single 3 mg dose by mouth.
      Omarigliptin dose administration will be followed by plasma sampling for both panels.
    

Intervention name(s): Omarigliptin
Intervention type(s): Drug
Intervention description(s): Single oral dose of 3 mg (3 x 1-mg capsules)
Other intervention name(s): MK-3102
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study To Estimate The Effect Of Omeprazole On The Pharmacokinetics Of Nelfinavir In Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 4

Summary: 
      To estimate the effects of omeprazole on the pharmacokinetics of nelfinavir in healthy
      subjects
    


Intervention name(s): Nelfinavir and Omeprazole
Intervention type(s): Drug
Intervention MeSH terms: Nelfinavir; Omeprazole
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
18-Week, Randomized, Double-blind, Placebo Controlled, Forced Titration Study of Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      Designed to evaluate dose response of force-titrated prandial administration of TI as
      compared to placebo (TP) in subjects with Type 2 diabetes who were suboptimally controlled
    


Intervention name(s): Technosphere Insulin; Technosphere Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Technosphere Insulin Inhalation Powder; Technosphere Inhalation Powder
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Facilitating Completion of HPV Vaccination
Condition: Adolescent Immunizations Among Clinic Population
Study type: Observational

Summary: 
      With the surge in use of electronic media among adolescents, a strategy that has been
      utilized to increase HPV4 uptake in girls has been reminder text messaging to their parents.
      To date, no published study has looked at the effectiveness of texting adolescents themselves
      (especially boys) rather than their parents OR compared texting to social network sites to
      increase HPV knowledge and uptake of HPV vaccination in boys. Interactive technology-based
      interventions targeted at youth are feasible in North Carolina for the following reasons: (1)
      through the NC Minors' Consent Law adolescents can consent to the prevention, diagnosis, and
      treatment of sexually transmitted diseases (N.C. Gen. Stat. § 90-21.5(a); and (2) many school
      based health centers can provide immunizations. Since HPV infection is a sexually transmitted
      infection, NC teens do not have to get consent for HPV prevention (i.e., vaccination).

      To optimize HPV vaccination in young people, especially males, communication strategies are
      needed to motivate adolescents to get themselves vaccinated. Texting has been demonstrated to
      be a feasible, popular, and effective method of sexual health promotion to young people with
      a relatively low withdrawal rate, positive feedback, and an observed improvement in sexual
      health knowledge and STI testing (12). Social media communication strategies are a new and
      potentially effective channel for communicating public health messages about HPV vaccine that
      are also likely to increase HPV initiation and completion among adolescent girls in addition
      to boys.

      According to the NC Immunization Registry, as of March 8, 2011, only 2% of boys ages 9-13 had
      received at least one dose of HPV vaccine. In the investigators continuity clinic less than
      50 percent of adolescents are fully immunized. This project will identify social behavioral,
      emotional, and cognitive correlates and predictors that help explain why teens pursue,
      complete, and do not complete HPV vaccination, and develop a social media communication
      intervention collaboratively with teens to increase HPV vaccine initiation and completion.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adolescent males and females age 11-21 at a Pediatric clinic
Safety, Tolerability and Pharmacodynamic Effect of Fazirsiran (TAK-999, ARO-AAT)
Condition: Alpha 1-Antitrypsin Deficiency
MeSH terms: Alpha 1-Antitrypsin Deficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of AROAAT2001 (SEQUOIA) is to evaluate the safety, efficacy and tolerability of
      multiple doses of the investigational product, Fazirsiran Injection, administered
      subcutaneously to participants with alpha-1 antitrypsin deficiency (AATD).
    

Detailed description: 
      Participants will be enrolled to receive multiple subcutaneous injections of Fazirsiran
      Injection (also referred to as TAK-999 Injection or ARO-AAT Injection) or placebo. Eligible
      participants will require a pre-dose biopsy completed as part of the study within the
      screening window. However, any participant with a biopsy result within 1 year of screening
      showing no fibrosis does not require a pre-dose biopsy. Only participants who have liver
      fibrosis will undergo a post-dose biopsy and may continue treatment in an open-label phase.
    

Intervention name(s): Fazisiran Injection; Placebo
Intervention type(s): Drug; Other
Intervention description(s): solution for subcutaneous (sc) injection; sterile normal saline (0.9% NaCl), calculated to match active comparator, for sc injection
Other intervention name(s): ARO-AAT Injection; TAK-999 Injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Comparative Study of Global 12 Lead Electroencephalogram to Frontal SedlineTM Electroencephalogram
Condition: Craniotomy; Transphenoidal Pituitary Resection
MeSH terms: Pituitary Diseases
Study type: Observational

Summary: 
      The fundamental reason for comparing the ability of the Frontal Sedline TM
      Electroencephalogram (PSA EEG) to standard Global 12 Lead Electroencephalogram (EEG) for
      burst suppression detection is to determine if a less expensive, less invasive and possibly
      more convenient bifrontal EEG monitor can be effective for evaluation of anesthesia-induced
      intraoperative burst suppression therapy (IBST) for cerebral protection.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients scheduled for elective craniotomy or transphenoidal pituitary resection at
        LLUMC University Hospital in which the surgeon has requested intraoperative burst
        suppression therapy regardless of the inciting etiology will be eligible to participate in
        this study.
National Marrow Donor Program Long-Term Donor Follow-Up
Condition: Hematologic Neoplasms
MeSH terms: Hematologic Neoplasms
Study type: Observational

Summary: 
      This is an observational study of unstimulated bone marrow (BM) and filgrastim-mobilized
      peripheral blood stem cell (PBSC) donors. The primary goal is to evaluate the hypothesis that
      the incidence of targeted malignant, thrombotic and autoimmune disorders after unrelated
      hematopoietic stem cell donation are similar between unstimulated BM and filgrastim-mobilized
      PBSC donors.
    

Detailed description: 
      This is an observational study of unstimulated bone marrow (BM) and filgrastim-mobilized
      peripheral blood stem cell (PBSC) donors. The primary goal is to evaluate the hypothesis that
      the incidence of targeted malignant, thrombotic and autoimmune disorders after unrelated
      hematopoietic stem cell donation are similar between unstimulated BM and filgrastim-mobilized
      PBSC donors. Donors will undergo biennial surveys until study completion. Cases of targeted
      disorders will be reviewed by the medical monitors to confirm the veracity of the report.
    

Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        10,000 unstimulated BM donors and 20,000 filgrastim-mobilized PBSC donors
      
Keywords: malignant myeloid hematologic disorders; filgrastim; long term incidence; donors who received and in those who did not receive filgrastim.
Open-label Study to Investigate Systemic Exposure in Adult and Pediatric Atopic Dermatitis Patients Treated 8.5 Days With Pimecrolimus Cream 1% Under Occlusion
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will access the degree to which pimecrolimus is absorbed from pimecrolimus cream
      1% into the blood when applied repeatedly under occlusion (i.e. areas treated wrapped in a
      plastic film) over 8 days in patients with moderate to severe atopic eczema.
    


Intervention name(s): Pimecrolimus
Intervention type(s): Drug
Intervention MeSH terms: Pimecrolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atopic dermatitis; AD; pimecrolimus; blood; absorption; systemic
Individualized Lifestyle Intervention for Obesity Management Based on Obesity Phenotypes
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this protocol is to define an "individualized diet" approach based on obesity
      related phenotypes (pathophysiology obesity classification), which would increase weight
      loss, adherence, and weight loss maintenance.
    


Intervention name(s): Standard Lifestyle Intervention; Modified Lifestyle Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Research team will prescribe diet, exercise, behavioral plan for the participant to follow for the 12 week study. The lifestyle plan will be based on the Mayo Clinic Diet program.; Research team will prescribe diet, exercise, behavioral plan for the participant to follow for the 12 week study. The lifestyle plan will be based on the participants obesity phenotype.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Proof of Concept Study to Evaluate the Efficacy and Tolerability of Skinpen on Male and Female Subjects' Dorsal Hands as a Treatment of Hand Aging
Condition: Skin Aging
Study type: Interventional

Summary: 
      This proof of concept study is being conducted over the course of 60 days followed by a
      3-month post-treatment visit to assess the efficacy and tolerability of the Sponsor's SkinPen
      device when used to treat men and women with signs of aging on the dorsum of the hands.
      Overall assessment of clinical outcome and safety will be based on the evaluation of pre-and
      post-treatment photos comparing baseline to final visit. The subject's assessment of
      satisfaction will also be evaluated at Visit 3 and Visit 4. Finally, both the clinician's and
      subject's assessments will be characterized using a clinician assessment scale at the 3-month
      post-treatment visit.
    

Detailed description: 
      A total of 18 subjects will be enrolled in this study. These patients will be treated three
      times over the dorsum of the hand from the wrist to the knuckles each month for three months,
      followed by one follow-up visit at 3-months post-treatment.

      Blueberry and Crown Laboratories will be responsible for recruitment efforts. Subjects will
      be numbered sequentially in the order in which they qualify for entry into the study.

      3.2 Primary Endpoints • Clinician's global aesthetic improvement assessment (CGAIS) at
      3-months post-treatment.

      3.3 Secondary Endpoints

        -  Subject's global aesthetic improvement assessment (SGAIS) at 3-months post-treatment.

        -  Monitoring of adverse events throughout the course of the study. Safety Subject diaries
           will be monitored for resolution of anticipated treatment responses.

      3.4 Exploratory Endpoints

      • Bioinstrumentation: TEWL, hydration, elasticity, skin thickness measurements at each visit.
    

Intervention name(s): SkinPen Precision System
Intervention type(s): Device
Intervention description(s): Microneedling is a relatively new, minimally invasive technique originally developed for skin rejuvenation. Controlled micro-injury to the dermis via the application of several small needles connected to a motorized device stimulates the wound healing process, resulting in the formation of new tissue and blood vessels. The SkinPen by Crown Laboratories is an FDA-cleared microneedling device proven to improve the appearance of acne scars This study evaluates the clinical performance of the SkinPen device for the treatment of signs of aging on the back of the hand. We hypothesize that the SkinPen device will produce a significant improvement in dorsal hand appearance at 3 month post treatment visit, when compared with baseline scores. The assessments will be based on the Clinician's Global Aesthetic Improvement Scale, and the Subject's Global Aesthetic Improvement Scale at the 3 month post treatment visit.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Healthy Options Feasibility Study
Condition: Obesity; Sedentary Lifestyle; Dyslipidemia; Hypertension; Cigarette Smoking; Diabetes
MeSH terms: Dyslipidemias
Study type: Interventional

Summary: 
      The investigators hypothesize that having health care providers other than physicians within
      a "Groupe de Médecine de Famille" conduct cardiovascular risk assessments and teach lifestyle
      interventions to primary prevention patients will increase the likelihood that patients will
      adopt and maintain healthy lifestyles. These objectives will be supported by providing
      subjects with a cardiovascular risk profile estimating the subject's risk of cardiovascular
      disease and teaching them how to use the resources related to lifestyle changes available on
      the www.myhealthcheckup.com Web site.
    


Intervention name(s): CVD risk profile
Intervention type(s): Behavioral
Intervention description(s): Cardiovascular risk assessment and behavioral counselling
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: primary prevention; patient knowledge; nurse; exercise; smoking cessation; weight loss