bioihbjkbjnl/mcl2 huggingface dataset:
Phosphate Intake's Effect on the Skeletal System - Pilot
Condition: Healthy; Kidney Failure, Chronic
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of different amounts of phosphorus in
      the diet on hormones that control phosphorus and bone health both in men who are healthy and
      in ones who have moderate kidney disease.
    

Detailed description: 
      Chronic kidney disease affects 11% of the US population; over half of those affected have
      skeletal manifestations of their renal disease. Renal osteodystrophy is a complex disease, in
      which multiple mineral systems and related hormones play a role, including phosphate
      homeostasis. Phosphate regulation primarily depends on renal handling of phosphate, which is
      partly controlled by parathyroid hormone and vitamin D. However, other mediators in this
      system clearly exist. Recently, evidence has been accruing that one such factor may be FGF23,
      a protein produced by osteogenic cells. States of excess FGF23 are associated with marked
      phosphate wasting, hypophosphatemia, osteomalacia, and inappropriately low calcitriol. FGF23
      levels are measurable in healthy humans and markedly elevated in patients who require
      hemodialysis, although its physiologic role in either state is unknown. Some retrospective
      evidence suggests that FGF23 is affected by phosphate intake. We are performing a pilot study
      to gather preliminary data describing the response of FGF23 to changes in dietary phosphorus
      intake in healthy men and in men with moderate renal insufficiency. The specific aims of this
      pilot study are: 1) To examine the physiologic effects of alterations in dietary phosphorus
      on FGF23 in healthy subjects; 2) To examine the physiologic response of FGF23 to dietary
      phosphorus alterations in patients with moderate renal failure; 3) To assess whether serum
      levels of 1,25-dihydroxyvitamin D vary inversely with those of FGF23 when dietary phosphate
      is changed; 4) To determine the temporal pattern of calcitropic hormones and FGF23 in
      response to dietary phosphate changes; and 5) To determine the variability of the changes in
      serum FG 23 in response to dietary phosphate manipulations. The proposed research plan is a
      dietary intervention trial in which we will study the response of serum FGF23 levels to diets
      with varying phosphorus contents in healthy adults and adults with moderate renal
      insufficiency.
    

Intervention name(s): dietary phosphorus
Intervention type(s): Behavioral
Intervention description(s): varying amts dietary phosphorus
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Treatment of Hypertrophic Scars Using Fractional Laser and Fractional Laser-assisted Topical Corticosteroid Delivery
Condition: Hypertrophic Scars
MeSH terms: Hypertrophy; Cicatrix, Hypertrophic
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to evaluate the efficacy and safety of using ablative
      fractional laser- assisted topical corticosteroid delivery for the treatment of hypertrophic
      scar.
    

Detailed description: 
      Hypertrophic scars are common conditions that cause persistent symptom and can lead to severe
      psychosocial impairment. Intralesional corticosteroid have been a mainstay in the treatment
      of hypertrophic scars. However, there are many disadvantages of corticosteroid injection such
      as severe pain, skin atrophy, skin thinning, steroid acne, telangiectasia and
      hypopigmentation.

      Recent reports propose new treatment methods for hypertrophic scars with the use of
      fractional ablative lasers to create zones of ablation of the skin that may assisted the
      penetration of drugs to the skin.
    

Intervention name(s): 0.05% Clobetasol propionate; Petrolatum gel; Fractional Erbium:Yag (2,940-nm) laser
Intervention type(s): Drug; Drug; Device
Intervention description(s): 0.05% Clobetasol propionate was rubbed for 2 minutes on one side of the scar immediately after treated with fractional Erbium: YAG (2,940-nm) laser. The treatment was done in every 2 weeks for 4 sessions; Petrolatum gel was rubbed for 2 minutes on the other side of the scar immediately after treated with fractional Erbium: YAG (2,940-nm) laser.The treatment was done in every 2 weeks for 4 sessions; The parameter of the laser was 28 J/cm2, 5% spot density, 1 pass for the whole scar. The treatment was done in every 2 weeks for 4 sessions
Intervention MeSH terms: Clobetasol; Petrolatum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: fractional laser; hypertrophic scar; topical corticosteroid; laser assisted delivery systems
Clinical Application of Circulating Tumor DNA (ctDNA) in Patients With Late-stage Breast Cancer
Condition: Metastatic Breast Cancer; Circulating Tumor DNA; Gene Abnormality
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      This is a retrospective, observational, multi-center clinical study of circulating tumor DNA
      (ctDNA) application in late-stage breast cancers.
    

Detailed description: 
      This study aims to evaluate the feasibility of plasma ctDNA mutation spectrum and clonal
      spectrum in late-stage metastatic breast cancer patients. Meanwhile, this study tries to
      establish a model of ctDNA subtyping system to evaluate the molecular load of tumor, to
      evaluate the curative effect comprehensively and to detect the disease progression in
      advance. In addition, the investigators plan to explore the clonal evolution of ctDNA in
      patients with progressive disease (PD), and to monitor the changes of tumor heterogeneity
      from the molecular level, so as to provide reference for the analysis of drug sensitivity.
    

Intervention name(s): ctDNA testing
Intervention type(s): Diagnostic Test
Intervention description(s): ctDNA testing was performed for late-stage metastatic breast cancer patients to trace their ctDNA abnormality.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This cohort study recruited consecutive patients with recent progression of metastatic TNBC
        after multiple lines of chemotherapy or of HR+ or HER2+ metastatic breast cancer after
        multiple lines of endocrine or targeted therapy.
      
Biospecimen description: 
      Peripheral blood lymphocytes (PBL) and plasma
Safety and Feasibility of the ElastiMed's SACS
Condition: Compression; Vein
Study type: Interventional

Summary: 
      The main objective of this study is to demonstrate the safety and the feasibility of this
      device, and its ability to increase venous blood flow

      Primary safety Endpoint:

      To demonstrate the safety of the device- no serious adverse effect

      Primary feasibility Endpoint:

      Increase the blood flow velocity

      The blood flow will be detected by a Duplex Ultrasonography test at the popliteal vein and
      the femoral vein.

      The volunteers will rest at controlled environment room . Measurements will be performed
      after 30 min of rest without the device on the leg (baseline) and after 30 min of device
      activity .
    


Intervention name(s): ElastiMed's SACS
Intervention type(s): Device
Intervention description(s): A wearable medical device that improve circulation using smart materials
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Magnetic Acupressure in Reducing Pain in Cancer Patients Undergoing Bone Marrow Aspiration and Biopsy
Condition: Hematopoietic/Lymphoid Cancer; Pain
Study type: Interventional

Summary: 
      RATIONALE: Acupressure may help relieve pain in cancer patients undergoing bone marrow
      aspiration and biopsy. It is not yet known whether magnetic acupressure is more effective
      than sham acupressure in reducing pain in cancer patients undergoing bone marrow aspiration
      and biopsy.

      PURPOSE: This randomized clinical trial is studying magnetic acupressure to see how well it
      works compared with sham acupressure in reducing pain in cancer patients undergoing bone
      marrow aspiration and biopsy.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To compare pain rating in cancer patients undergoing bone marrow aspiration and biopsy
           (BMAB) treated with magnetic acupressure at bilateral large intestine 4 (LI 4) points vs
           sham acupressure at bilateral proximal fourth interosseus space of the hand.

      Secondary

        -  To compare the duration of BMAB, patient's rating of the procedure, and patient's
           willingness to receive acupressure during subsequent BMABs.

      OUTLINE: Patients are stratified according to the number of prior bone marrow aspirations and
      biopsies (BMAB) (0-1 vs ≥ 2) and type of procedure (bone marrow aspiration alone vs BMAB).
      Patients are randomized to one of two treatment arms.

        -  Arm I (acupressure): Patients receive acupressure at bilateral large intestine 4 (LI 4)
           points using Haci Magnetic Acupressure Suction Cups (MASC) during BMAB.

        -  Arm II (sham acupressure): Patients receive acupressure at bilateral proximal fourth
           interosseus space of the hand using the same size MASC as in arm I during BMAB.

      Patients in both arms also receive analgesic and anxiolytic medications as determined by the
      acupressure operator and physician.

      Patients complete a questionnaire before and after BMAB to assess pain experienced before and
      during BMAB and their attitude towards the procedure.
    

Intervention name(s): questionnaire administration; acupressure therapy; biopsy; bone marrow aspiration; pain therapy
Intervention type(s): Other; Procedure; Procedure; Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Supportive Care
Keywords: pain; hematopoietic/lymphoid cancer
The Effects of Cosmetic Care on Body Image in Young Chinese Breast Cancer Patients Receiving Chemotherapy
Condition: Body Image
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This study aimed to explore the effects of cosmetic care on body image (BI), and social
      avoidance and distress (SAD) in young Chinese breast cancer patients, aged 18-40 years old,
      receiving adjuvant chemotherapy. This was a single-center, 2-arm quasi-experimental study.
      The control group received usual care, while cosmetic care was added to the intervention
      group. The primary outcomes were BI and SAD accompanying chemotherapy, and the secondary
      outcome was the appearance satisfaction.
    

Detailed description: 
      Background: The diagnosis and treatment of breast cancer may still bring severe psychological
      trauma to women. Cosmetic care is an effective measure to enhance patients' psychosocial
      functioning, which can help cancer patients cope with disfigurement-related adverse effects.

      Objectives: This study aimed to explore the effects of cosmetic care on body image (BI), and
      social avoidance and distress (SAD) in young Chinese breast cancer patients, aged 18-40 years
      old, receiving adjuvant chemotherapy.

      Study design: This was a prospective, 2-arm quasi-experimental study, comprising two groups:
      the controlled group and the interventional group. In order to avoid interference, the two
      groups of participants were recruited at different periods. The control group was recruited
      from Jan 2015 to Mar 2015, and the intervention group was recruited from January 2016 to
      September 2017. All participants came from the department of a breast surgery in Shanghai,
      China.

      Control condition: Participants in the control group received usual care during adjuvant
      chemotherapy.

      Intervention: Participants in the intervention group received cosmetic care in combination
      with usual care.

      Ethical approval: Ethical approval of this study was obtained from the ethical committee of a
      cancer center in Shanghai. The approval number was 1403132-2. Informed consent was explained
      to the participants and the forms were signed by them.

      Data analyses: The IBM SPSS 22.0 was used to analyze all the data.
    

Intervention name(s): Cosmetic care
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: body image; cosmetic care; psychosocial support; social avoidance and distress; young breast cancer
Dermatological Evaluation of Topic Compatibility-Dermacyd Tina Gel Sweet Flower
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the absence of irritation potential (primary
      dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the
      product Dermacyd Tina Gel Sweet Flower.
    


Intervention name(s): Lactic acid (Dermacid)
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Prospective Evaluation of Safety and Efficacy Vertebral Drug-eluting Stent System
Condition: Vertebrobasilar Insufficiency
MeSH terms: Vertebrobasilar Insufficiency
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of Firehorus vertebral
      artery rapamycin-target-eluting stent system (hereinafter referred to as Firehorus) in
      treatment of symptomatic vertebral artery stenosis.
    

Detailed description: 
      This clinical trial utilizes the prospective, multicenter, single-arm target value trial
      design, to evaluate the safety and efficacy of Firehorus vertebral artery
      rapamycin-target-eluting stent system (hereinafter referred to as Firehorus) in clinical use,
      for which 5 (or more) institutions will be selected as Clinical Trial Centre.Subjects will be
      screened in accordance with the inclusion and exclusion criteria of the this protocol and
      will be treated with Firehorus. Immediate stent implantation success rate of all subjects
      after surgery will be recorded, DSA angiographic follow-up will be performed at six months
      (±30 days) after surgery to assess the incidence of stent restenosis ( stenosis ≥ 50%) of the
      subjects, and the subjects will be followed up at 30 days (±7 days), 6 months (± 30 days), 12
      months (± 30 days) after surgery , so as to evaluate the safety and efficacy of Firehorus in
      clinical use. The expected participating duration of each subject from enrollment to complete
      the follow-up is 12 months (± 30 days).
    

Intervention name(s): Drug-eluting stent
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vertebral artery stenosis; drug-eluting stent
A Study to Assess the Relative Bioavailability of 4 Formulations of Fentanyl Transdermal System Compared Against DUROGESIC Fentanyl Transdermal Patch After Single Application in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics and relative bioavailability of
      4 new formulations of fentanyl transdermal patch in healthy participants after a single
      application for 72 hours.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), randomized (the
      study drug is assigned by chance), 4-way crossover (participants will receive different
      interventions sequentially during the trial) study. The study will assess the
      pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how
      it is removed from the body over time) and relative bioavailability (the extent to which a
      drug or other substance becomes available to the body) of 4 new formulations of fentanyl
      transdermal patch, TDS-Concept 1 50 µg/h, TDS-Concept 2 50 µg/h, TDS-Concept 3 50 µg/h and
      TDS-Concept 4 100 µg/h compared with DUROGESIC fentanyl 50 µg/h in healthy participants after
      a single application. All participants will be randomly assigned to 1 of 8 possible treatment
      sequences. During the 4 single-application treatment periods, each transdermal patch will be
      worn, on a different application site on the lateral side of the upper arm, continuously for
      72 hours. The treatment periods will be separated by a washout period (period when receiving
      no treatment) of at least 8 and no more than 14 days. The total study length is from 64 days
      to a maximum of 82 days.
    

Intervention name(s): Treatment A: DUROGESIC (8.4 mg fentanyl); Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl); Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl); Treatment D: Transdermal System-Concept 3 (7.1 mg fentanyl); Treatment E: Transdermal System-Concept 4 (11.0 mg fentanyl)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): One DUROGESIC transdermal patch containing 8.4 mg of fentanyl applied on the skin for 72 hours.; One transdermal system-concept 1 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.; One transdermal system-concept 2 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.; One transdermal system-concept 3 patch containing approximately 7.1 mg of fentanyl applied on the skin for 72 hours.; One transdermal system-concept 4 patch containing approximately 11.0 mg of fentanyl applied on the skin for 72 hours.
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Fentanyl; Transdermal patch; DUROGESIC
Clinical Trial to Investigate the Pharmacokinetics of Second-Line Anti-Tuberculosis Agents
Condition: Healthy
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to investigate the pharmacokinetic characteristics of second-line
      anti-tuberculosis agents after oral/intramuscular administration in healthy male volunteers.
    


Intervention name(s): Levofloxacin and Streptomycin added; Moxifloxacin and Kanamycin added
Intervention type(s): Drug; Drug
Other intervention name(s): Cycloserine; P-aminosalicylic acid; Prothionamide; Pyrazinamide; levofloxacin; steptomycin; Cycloserine; P-aminosalicylic acid; Prothionamide; Pyrazinamide; moxifloxacin; kanamycin
Intervention MeSH terms: Moxifloxacin; Levofloxacin; Ofloxacin; Cycloserine; Pyrazinamide; Aminosalicylic Acid; Streptomycin; Kanamycin; Prothionamide; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antituberculosis agents; Pharmacokinetics
Neuromuscular and Proprioceptive Training in Football Players
Condition: Football Players; Sport Injury; Sports Physical Therapy
MeSH terms: Athletic Injuries
Study type: Interventional

Summary: 
      The objective of this study was to determine the effect of proprioceptive and neuromuscular
      training on landing errors and balance of the football players. This was randomized
      controlled trial in which 40 football players were randomly allocated into experimental and
      control group. The control group followed conventional exercise plan while experimental group
      players were being trained under Myklebust's training program. Data were collected at
      baseline and after follow-up of five weeks Landing Error Score System (LESS) and Biodex
      Single Leg Stability (SLS) score. Data were analyzed using statistical package for social
      sciences (SPSS)-21.
    

Detailed description: 
      Anterior cruciate ligament (ACL) injuries are a severe public health issue from both an
      economic and general wellness view. This burden will be reduced by promoting compliance and
      the use of injury prevention programs. To reduce injury rates, trainers, athletes, parents,
      and the team of sports medicine need to know the advantages of injury prevention programs.
      Parents and employees in sports medicine want a program that can decrease the risk of injury.
      Coaches and athletes are looking for a program that will also increase athletic efficiency
      without taking time off exercise, time that would otherwise be spent honing sport-specific
      abilities. Injury prevention programs in youth athletics will promote neuromuscular
      enhancements and create appropriate long-term techniques while instantly preparing the
      athlete for competition.

      Various studies have been done to assess the role of proprioceptive and neuromuscular
      exercises on reducing incidence of ACL injury. No conclusive result has been established as
      yet that these type of exercises really reduce the incidence of ACL injury or not. However,
      it is found that by performing certain exercises there is improvement in biomechanics of jump
      landing as predicted by LESS score which is a reliable tool to establish risk of ACL and
      other lower limb injury in an athlete. Therefore the investigators have used a lower limb
      injury prevention program to assess its effectiveness in reducing LESS score.
    

Intervention name(s): Neuromuscular and Proprioceptive Training; Conventional Training
Intervention type(s): Other; Other
Intervention description(s): Myklebust's training program (floor exercises, mat exercises, and wobble board exercises for 5 weeks); Running, Sprinting, Agility training and Dynamic stretching for five weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: ACL Injury; Landing Error Score System; Neuromuscular Training; Proprioceptive Training; Soccer