bioihbjkbjnl/mcl2 huggingface dataset:
Effects Of Native Collagen Type 2 Treatment
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The aim of this study was to evaluate symptomatic efficacy of native collagen type 2 on joint
      pain and function and its effects on urinary biological markers related to cartilage
      degeneration in patients with knee osteoarthritis.
    

Detailed description: 
      39 patients diagnosed with knee osteoarthritis were separated into two groups. The 1st group
      includes 19 patients given 1500mg/day paracetamol, the 2nd group consists of 20 patients
      given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three
      months.Pretreatment and posttreatment Visual Analog Scale, Western Ontario and McMaster
      Universities Osteoarthritis Index (WOMAC), 20-m walking time and Short Form-36 (SF-36),
      Coll2-1, Coll2-1NO2 and Fibulin-3 levels in urine were compared.
    

Intervention name(s): paracetamol; paracetamol+native collagen type 2
Intervention type(s): Drug; Drug
Intervention description(s): 1500 mg; paracetamol (1500 mg) + native collagen type 2 (10mg)
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: knee osteoarthritis, native collagen type 2, paracetamol
Effects of Low-dose Complex B-vitamins on Homocysteine and Framingham Risk Score Among Chinese Elderly
Condition: Hyperhomocysteinemia
MeSH terms: Hyperhomocysteinemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate whether low dose complex B-vitamins (folic
      acid,vitamin B6 and vitamin B12) can lower the risk of developing hyperhomocysteinemia in an
      apparently healthy population with low folate/B12 and high Hcy status.
    

Detailed description: 
      Hyperhomocysteinemia has been well known as an independent risk factor for CVD. Numerous
      studies have demonstrated that certain kinds of vitamin B(folic acid,vitamin B6 and vitamin
      B12)can reduce Hcy level and may prevent CVD. However, the majority of those studies has been
      conducted always used high dose vitamin in patient or high risk population. There is thus
      absence of data that the effectiveness of low dose complex B-vitamins on the apparently
      Chinese elderly population with relative sub-nutritional status. Our study is just focus on
      the aforementioned aspect.
    

Intervention name(s): Low-dose complex B-vitamins
Intervention type(s): Dietary Supplement
Intervention description(s): The complex B vitamins supplement has been made as capsule and packaging 31 capsules in 1 bottle with a pre-determined code number on its cover. The main content contains either vitamin C 50mg alone or combination with folate 0.4 mg, vitamin B6 2mg, vitamin B12 10μg and vitamin C 50 mg. Two kinds of the supplements could not be discriminated by appearance, smell, taste, size and package.volunteers in either arms are required to take 1 capsule per day and last for 48 weeks.
Other intervention name(s): vitamin supplement
Intervention MeSH terms: Vitamins; Vitamin B Complex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: homocysteine; folate acid,; vitamin B; random controlled trail
Offset of Ticagrelor's Effect on Endothelial Function as Assessed With Peripheral Arterial Tonometry (EndoPAT Assay)
Condition: Coronary Artery Disease; Endothelial Function
MeSH terms: Coronary Artery Disease
Study type: Observational

Summary: 
      Ticagrelor administration, whose molecule resembles to adenosine, led to reduction in overall
      mortality and thrombotic cardiovascular (CV) events when directly compared to clopidogrel in
      the PLATO trial, implicating possible pleiotropic actions for the drug. It has been shown
      that ticagrelor increases adenosine concentration, by interfering with its red blood cells'
      uptake and by inducing the release of ATP which is then converted to adenosine. Recent
      studies in healthy volunteers and patients with coronary artery disease (CAD) have shown that
      ticagrelor increases the coronary blood flow in response to intravenous adenosine
      administration. Ticagrelor administration, in comparison with other P2Y12 inhibitors, may
      influence the endothelial function, as assessed by the Peripheral Arterial Tonometry method
      (EndoPAT 2000 system (Itamar Medical, Caesarea, Israel), which is a method for evaluating
      endothelial dysfunction and has been found to positively correlate with flow mediated
      dilatation (FMD).

      This is a prospective, observational study, which will be conducted in patients with coronary
      artery disease subjected to percutaneous coronary intervention (PCI) under ticagrelor
      maintenance dose (MD) 90mg x 2, who are about to stop treatment, due to completion of 1 year
      antiplatelet therapy. Eligible patients will be subjected to peripheral arterial tonometry at
      Day 0 (immediately after receiving the last pill of ticagrelor) and at day 2 and day 5 post
      study drug discontinuation. Peripheral blood sample will be taken from the patients at Day 0
      for genotype analysis.
    


Intervention name(s): Peripheral arterial tonometry (EndoPAT)
Intervention type(s): Device
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with coronary artery disease under ticagrelor maintenance dose, who are about to
        discontinue ticagrelor, due to completion of 12 months dual antiplatelet therapy.
      
Keywords: ticagrelor; endothelial function; peripheral arterial tonometry
Physiopathologic Aspects and Quality of Life in Participants With Eye Dark Circles
Condition: Periorbital Hyperpigmentation
MeSH terms: Hyperpigmentation
Study type: Observational

Summary: 
      This study will evaluate the physiopathologic characteristics of dark circles in participants
      with various ethnicities and Fitzpatrick Skin Types and the impact of the dark circles on the
      quality of life.
    


Intervention name(s): Skin imaging; Facial cleanser
Intervention type(s): Device; Other
Intervention description(s): Non-invasive in vivo skin imaging will be taken with the VivoSight Ox Optical Coherence Tomography (OCT).; Facial cleanser prior to procedures.
Other intervention name(s): SkinMedica Facial Cleanser
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants at a Clinical Research Center.
A Trial in Healthy Female Subjects to Compare the Pharmacokinetics of Ethinyl Estradiol of NuvaRing®, a Contraceptive Patch (EVRA(TM)) and an Oral Contraceptive (Microgynon® 30) (Study 34237 (P06650)) (COMPLETED)
Condition: Contraception
Study type: Interventional
Phase: Phase 4

Summary: 
      An open-label, randomized, parallel group trial in healthy female subjects to compare the
      pharmacokinetics of ethinyl estradiol (EE) of NuvaRing®, a contraceptive patch (EVRA(TM)) and
      an oral contraceptive (Microgynon® 30).
    


Intervention name(s): Levonorgestrel (LNG)/Ethinylestradiol (EE) oral contraceptive tablets; norelgestrominum and ethinylestradiol patch oral contraceptive patch; Nuvaring ™ (etonorgestrel/ethinylestradiol)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): LNG/EE oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.; A contraceptive patch (EVRA ™), one patch for 7 days for three consecutive weeks, 3 patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.; NuvaRing ™ , one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
Other intervention name(s): Microgynon; Batch Number: 374A 01K05; EVRA ™; Batch number : 0311264
Intervention MeSH terms: Contraceptive Agents; Levonorgestrel; Ethinyl Estradiol; Ethinyl estradiol, levonorgestrel drug combination; NuvaRing; Contraceptives, Oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study Assessing the Effect of 3-week Treatment With One of Three Oral Doses of Quinagolide
Condition: Ovarian Hyperstimulation Syndrome
MeSH terms: Ovarian Hyperstimulation Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Women included in this study are undergoing controlled ovarian hyperstimulation for assisted
      reproductive technologies (ART) and present with signs of moderate risk of developing OHSS.
    

Detailed description: 
      No data to be entered.
    

Intervention name(s): Norprolac; Norprolac; Norprolac; Norprolac
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo; Quinagolide; Quinagolide; Quinagolide
Intervention MeSH terms: Quinagolide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Combined Administration of Teripapartide and Antiresorptive Agents in Postmenopausal Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Increased bone formation in the absence of accelerated resorption is resulting in a marked
      anabolic response to teriparatide (TPTD) during the early phase after treatment initiation.
      Months later, due to coupling mechanism, the sustained increase of bone formation and ongoing
      anabolic effects are accompanied by significantly increased bone resorption as well.
      Antiresorptives influence the balance of bone formation and resorption. Therefore the
      investigators aim is to investigate the effects of the addition of antiresorptives to the
      second half of TPTD cycle when resorption is already also markedly elevated.
    

Detailed description: 
      We prospectively randomize 125 postmenopausal women after 9 months of TPTD treatment into
      three different open-label groups for another 9 months: either alendronate (ALN, 70 mg/week),
      raloxifene (RAL, 60 mg/day) or no medication (TPTD mono) on top of ongoing TPTD treatment.

      All subjects receive daily supplementation of 1000mg calcium and 800 IU vitamin D.

      Serum level of intact amino terminal propeptide of type I procollagen (PINP) and type 1
      collagen cross-linked C-telopeptide (CTX) as well as DXA measurement at the spine, total hip
      and femoral neck BMD are evaluated at TPTD treatment initiation, at baseline of randomization
      to antiresorptive therapy as well as at 3 and 9 months during the combination
      treatment.Volumetric BMD values will be also determined.
    

Intervention name(s): teriparatide; teriparatide and raloxifene; teriparatide and alendronate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): teriparatide 20 ug/day, sc.; teriparatide 20 ug/day sc. raloxifene 60mg oral daily; teriparatide 20 ug/day sc. alendronate 70mg oral weekly
Other intervention name(s): Forteo; Forteo; Evista; Forteo; Fosamax
Intervention MeSH terms: Alendronate; Teriparatide; Raloxifene Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: teriparatide; alendronate; raloxifene; bone mineral density
Assessing Efficacy of Axillary Web Syndrome Treatment
Condition: Axillary Web Syndrome
MeSH terms: Syndrome
Study type: Interventional

Summary: 
      The aim of this study is verify the effectiveness of manual maneuver associated with
      stretching exercises in the treatment of Axillary Web Syndrome.
    

Detailed description: 
      Axillary Web Syndrome (AWS) is one of the short / medium-term sequela of surgical treatment
      for breast cancer with axillary dissection (AD) or sentinel lymph node biopsy (SLNB), with
      incidence reported in literature between 28% and 72%. AWS could be described as a
      thrombophlebitis of veno-lymph vessels due to a trauma of the region subjected to surgery,
      with the same characteristics of "Mondor's disease" diagnosed in post-traumatic and surgical
      areas where is a large presence of veno-lymphatic capillaries.

      The syndrome onset occur in approximately 2-4 weeks after the surgery and its complete
      regression happen in 3-6 months after the onset. The clinical signs frequently described are
      pain and tension during movement in the axillary region, elbow, forearm and wrist, following
      the arm lymphatic pathway. Moreover, patients report difficulties in moving the arm into
      activities that require a moderate range of motion and could feel and see in the affected arm
      cords similar to a tendon. Even if the impairment can cause disability for a limited period
      of time, rehabilitation is usually advice to prevent further complications such as frozen
      shoulder, articular impeachment syndrome and long-term chronic pain, complications that could
      worsen patient's quality of life with a significant increase in costs and time to recovery.

      Nowadays there are no studies in the literature that demonstrate the effectiveness of
      physiotherapy in AWS, with just case reports describing different treatments techniques,
      without a scientifically defined experimented rehabilitation protocol.

      This experimental, monocentric, randomized clinical trial wants verify the effectiveness of a
      manual maneuver associated with stretching exercises in the treatment of AWS.
    

Intervention name(s): Manual manoeuver + stretching; stretching exercise
Intervention type(s): Other; Other
Intervention description(s): Patients in experimental group will receive, after AWS diagnose, a manual manoeuver to snap the cord, follow by a demonstration and education of the exercise to be made at home.; Patients in control group will receive, after AWS diagnose, just a demonstration and education of the exercise to be made at home.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Breast Neoplasm; Physiotherapy; Rehabilitation
Location Initiated Individualized Texts for Adolescent Health (LIITAH)
Condition: Overweight; Obese; Healthy
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The goal of this study is to test whether the mobile application (app.) helps adolescents
      make healthy food choices, decreasing calories purchased from restaurants, fewer number of
      visits to restaurants, and if it has an impact on their body mass index (BMI). Eligible
      adolescents will be enrolled in the study along with a parent for approximately 6 months.
    


Intervention name(s): Full version of the LIITah App.; Partial App. (ELI and SNAP only)
Intervention type(s): Other; Other
Intervention description(s): Participants will download the LIITAH app. For the first 2 weeks the app. will only record presence in a restaurant and ask users to submit photos of their food. in week 3 all of the program features will be activated.; Participants will download the LIITAH app. It will detect their presence in a restaurant and users will submit annotated photos of their purchases
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Motivational Parameters Associated With Physical Activity and Sedentary Behaviors Among Persons With Chronic Diseases
Condition: Health Behavior
MeSH terms: Chronic Disease
Study type: Observational

Summary: 
      The principal aim of these researches is to explored the role of motivational parameters,
      including: automatic and controlled psychological processes and self-regulatory capacities,
      in physical activity and sedentary behaviors adoption and maintenance. Precisely
      investigators are interested in change in motivational and self-regulatory processes during
      rehabilitation programs and their prospective influences on self-reported and objective
      behaviors among persons with chronic diseases.
    

Detailed description: 
      Automatic processes refered to implicit attitudes measured through the implicit association
      test (IAT) and single category (SC-IAT). Controlled processes refered to the variables of the
      Theory of Planned Behavior measured by questionnaire. Self regulatory capacities refered to
      the concept of impulsivity measured by questionnaire and executive functions measured through
      the STROOP task and Wisconsin Card Sorting Task.

      Physical activity and sedentary behaviors are measured by questionnaire and accelerometry.
    

Intervention name(s): Rehabilitation
Intervention type(s): Other
Intervention description(s): The intervention (routine care) correspond to five weeks rehabilitation program
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Person with chronic illness such cardio-respiratory and metabollic diseases
      
Keywords: physical activity; sedentary behavior; implicit attitudes; self regulation; intention; chronic diseases
Safety and Feasibility of Pulmonary Surgery Marker System in the Intraoperative Localization of Small Pulmonary Nodules
Condition: Lung Neoplasms
MeSH terms: Lung Neoplasms; Multiple Pulmonary Nodules
Study type: Interventional

Summary: 
      As the detection of small pulmonary nodules continuously grows, the intraoperative
      localization of small pulmonary nodules is in great demand. The intraoperative localization
      nowadays is usually done under local anesthesia before surgery. There is a certain rate of
      failure and complication. The result of our early animal experiments show that the pulmonary
      surgery marker system can deliver the intraoperative localization safely and precisely under
      anesthesia, and the average distance between the localization and the simulated lesion is
      less than 5mm during surgery. Therefore, the safety and feasibility of the system require
      further evaluation in patients
    

Detailed description: 
      This is a prospective, single-center clinical trial initiated by the investigator. LungBrella
      marker can be accurately implanted into a predetermined position in the lung assisted by
      JediVision software and successfully marked the pulmonary nodules which needs to undergo
      Video-assisted thoracoscopic surgery. The study is expected to enroll 10 patients. Finally,
      the effectiveness and safety of the method will be evaluated. This method not only can
      complete pulmonary nodule localization in the operating room without occupying the resources
      of radiology department, but also can let patients receive pulmonary nodule location after
      anesthesia. Thereby the risks during transportation are avoided and the suffering of patients
      is reduced.
    

Intervention name(s): LungBrella marker implantation and VATS partial lobe resection
Intervention type(s): Device
Intervention description(s): The enrolled patients will receive a plain chest CT scan,then the data be loaded into JediVision software. The JediVision software can navigate the location of nodule and facilitate the implantation of LungBrella marker in the operating room after general anesthesia,then the patients will receive VATS partial lobe resection .
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lung neoplasm; localization of lung nodules; ground glass opacity
Multiple Breath Nitrogen Washout in Healthy and Cystic Fibrosis Adults
Condition: Cystic Fibrosis; Healthy
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      This study compares the lung clearance index (LCI) in cystic fibrosis and healthy adults
      obtained with two different multiple breath nitrogen washout (MBWN2) devices. Each
      participants will perform the test (LCI) in duplicate on each device.
    

Detailed description: 
      Using nitrogen as the inert gas, there are currently two commercially available devices that
      offer the possibility to measure the LCI. However, comparison between them are lacking. The 2
      MBWN2 devices are the "EasyOne Pro Lab" (ndd Medical Technologies, Zürich, Switzerland) and
      the "Exhalyzer D" (Eco Medics AG, Duernten, Switzerland).
    

Intervention name(s): Comparison of two MBWN2 devices : "EasyOne Pro Lab" versus "Exhalyzer D"
Intervention type(s): Device
Intervention description(s): Healthy and Cystic Fibrosis participants will perform the same day MBWN2 tests in duplicate with each device.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        CF : primary care clinic HC : community sample
      
Keywords: Lung Clearance Index; Cystic Fibrosis; Multiple Breath Nitrogen Washout
Assessment of Cognitive Function in Patients Undergoing Carotid Artery Stent Placement
Condition: Cognitive Function in Carotid Stenting
Study type: Observational

Summary: 
      To determine the effect of carotid artery stenting, on cognitive function, in patients with
      high grade carotid artery stenosis
    

Detailed description: 
      Single Center, Case Controlled design using pre and post stent cognitive function testin.
      Patients will serve as self controls to observe the effect, if any, of carotid stent
      placement on cognitive function in asymptomatic patients with high grade carotid artery
      stenosis
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with severe carotid artery stenosis
      
Keywords: carotid stenting; cognitive function; pre and post stent; severe carotid artery stenosis
Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib, Compared to DTPa-HBV-IPV and Hib Administered Separately
Condition: Hepatitis B; Diphtheria; Haemophilus Influenzae Type b (Hib); Poliomyelitis; Pertussis; Tetanus
MeSH terms: Hepatitis B; Diphtheria; Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals'
      (formerly SB Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared with separate
      administration of DTPa-HBV-IPV (Infanrix penta™) and Hib (Hiberix™) vaccine administered at
      3, 5 and 11 (or 12) months of age.
    


Intervention name(s): DTPa-HBV-IPV/Hib (Infanrix hexa™); DTPa-HBV-IPV (Infanrix penta™); Hib (Hiberix™)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Three doses administered intramuscularly; Three doses administered intramuscularly; Three doses administered intramuscularly
Intervention MeSH terms: Edetic Acid; Pentetic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: combination vaccine; DTPa-HBV-IPV; Hib