bioihbjkbjnl/mcl2 huggingface dataset:
BEMER in the Treatment of Pain in Fibromyalgia.
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Fibromyalgia is one the most common causes of chronic pain syndromes in women. It causes
      considerable costs in primary health care setting as well as specialized medical care
      sector.Electrotherapy and exercise therapy has shown to have short-term pain relieving
      effects in randomized controlled trials (RCT) among fibromyalgia patients. However, there is
      sparse knowledge about the effects of long-term RCTs in the treatment of pain in
      fibromyalgia, as there are no publications about cost-effectiveness analysis of such
      treatments.

      The aim of this study is to investigate whether the BEMER electromagnetic field therapy
      device has beneficial long-term effects in the treatment of pain, and whether it improves
      fibromyalgia patients' quality of life. In addition, this study investigates whether the
      BEMER device treatment is cost-effective in the treatment of fibromyalgia patients.
    

Detailed description: 
      The participants of this study are working age female patients from the Central Finland
      Health Care District, and who have been treating because of severe pain. After eligibility
      has been assessed by health-related questionnaire and clinical examination, the participants
      will be randomly assigned into the treatment or control group. Treatment group patients will
      receive the loan activated BEMER-care unit, while controls will receive inactivated sham
      BEMER-unit. All participants will use the device regularly on a daily bases over three
      months. After one month treatment break, the treatment group will become a control group and
      control group will become a treatment group according cross-over design principle. Switching
      the groups will take place by changing the BEMER devices during the break. Throughout the
      study, both participants and researchers are unaware whether the participants are using
      activated or inactivated BEMER-devices. The research will be carried out and coordinated by
      Central Finland Central Hospital, and the research project will take place between September
      2014 and June 2018.
    

Intervention name(s): BEMER electromagnetic field therapy
Intervention type(s): Device
Intervention description(s): To study the effects of three months electromagnetic field therapy on pain in women with fibromyalgia.
Other intervention name(s): BEMER, Innomed International AG, Lichtenstein
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fibromyalgia; Electromagnetic field therapy; Randomized controlled trial
Ability of Aridol to Detect Bronchial Hyperresponsiveness in Suspected Asthmatics
Condition: Asthma
MeSH terms: Asthma; Bronchial Hyperreactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3 study to determine the sensitivity and specificity of the Aridol bronchial
      challenge test to detect bronchial hyperresponsiveness in patients with suspected asthma.
      Patients with suspected asthma of either gender, aged between 6 and 50 years, with only
      mildly impaired lung function (FEV1 >70%) are to be tested with three different bronchial
      hyperresponsiveness challenges (Aridol, exercise and methacholine), and the results compared.
      A clinical diagnosis will also be made at the end of the study.
    


Intervention name(s): Aridol; Methacholine; Exercise challenge
Intervention type(s): Drug; Drug; Procedure
Intervention MeSH terms: Methacholine Chloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Diagnostic
Keywords: bronchial; hyperresponsiveness
Strength Training and ADLs in Childhood Leukemia and Lymphoma Patients
Condition: Childhood Cancer
MeSH terms: Lymphoma; Leukemia
Study type: Interventional

Summary: 
      Reduced activity levels and reduced muscular strength could severely impair the activities of
      daily living (ADLs) in pediatric leukemia and Non-Hodgkin lymphoma patients. Increased muscle
      strength is associated with improved accomplishment of ADLs and consequently greatest
      possible normality, autonomy and mobility. Primary outcome of this RCT (n=20/20) is the
      analysis of effects of a treatment-associated and close to every day life strength training
      (2-3 times/week) compared to a general exercise program (standard care).
    


Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): specific strength training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: exercise; strength training; activities of daily living; childhood cancer; leukemia; Non-Hodgkin lymphoma
Post Authorisation Safety Study of Renvela® in Chronic Kidney Disease Patients Not on Dialysis With Hyperphosphataemia
Condition: Hyperphosphataemia; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperphosphatemia
Study type: Observational

Summary: 
      The primary objective of this study is to assess in a post-approval clinical setting the
      safety profile of sevelamer carbonate (Renvela®) tablets and powder in adult
      hyperphosphataemic chronic kidney disease (CKD) patients not on dialysis with serum
      phosphorus ≥1.78 mmol/L. Patients will be treated in accordance with the Renvela® Summary of
      Product Characteristics (SmPC) and followed according to the investigator's standard clinical
      practice management. Each patient will be followed up for 12 months or up to the time they
      start dialysis, whichever occurs first.
    


Intervention name(s): sevelamer carbonate (Renvela®)
Intervention type(s): Drug
Intervention description(s): 800 mg tablets or 2.4 g powder for oral suspension should be administered as instructed in the Renvela® SmPC.
Intervention MeSH terms: Sevelamer
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult Chronic Kidney Disease (CKD) patients not on dialysis with serum phosphorus ≥ 1.78
        mmol/L.
Dysphagia Awareness In Medical and Nursing Students
Condition: Dysphagia; Awareness; Students
MeSH terms: Deglutition Disorders
Study type: Observational

Summary: 
      A survey consisting of questions about swallowing and dysphagia was provided to universities'
      medicine and nursing students. The answers of students were analyzed
    

Detailed description: 
      The undergraduate training of health care professionals may provide the necessary theoretical
      and practical approach to future nurses and physicians. This study was planned to investigate
      students' dysphagia knowledge level and awareness in the medicine and nursing faculties. A
      survey consisting of questions about swallowing and dysphagia was provided to universities'
      medicine and nursing students. The answers of students were analyzed
    

Intervention name(s): no intervention group
Intervention type(s): Other
Intervention description(s): The awareness of medical and nursing students were evaluated. there is no intervention
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        This study was conducted with students at medical and nursing faculties in Turkey
      
Keywords: dysphagia; awareness; medical students; nursing students
NIRS Monitoring to Detect AKI in Preterm Infants
Condition: Acute Kidney Injury; Premature Infant
MeSH terms: Acute Kidney Injury
Study type: Observational

Summary: 
      This study will examine the relationship of oxygen levels, using Near-infrared spectroscopy
      (NIRS) monitoring, and kidney injury in infants born prematurely. NIRS is a skin sensor which
      detects the amount of oxygen going to different organs, most often used to monitor the brain
      and kidney.
    

Detailed description: 
      This prospective, single-center study was conducted at UnityPoint Health-Meriter Hospital
      (Madison, WI, USA) in preterm neonates admitted to a level III NICU from April 2018 to August
      2019. The primary study aim was to assess changes in RrSO2 with continuous renal NIRS
      monitoring to detect AKI during the first 7 days of age.

      The INVOS 5100 C (Somanetics, Troy, MI, USA) four channel NIRS monitors were used to measure
      RrSO2 (measured at the right or left flank) and Cerebral regional Somatic tissue Oxygenation
      (CrSO2; measured at the forehead) for all neonates. At each measurement site, for skin
      protection, subjects had a transparent Mepitel (with Safetac Technology, Norcross, GA)
      adhesive dressing placed with the adhesive neonatal NIRS sensor (INVOS OxyAlert NIRSensor,
      Covidien) adhered over the Mepitel dressing. Neither cerebral or kidney sensors were placed
      with ultrasound guidance. Tissue oxygenation was recorded every 3 seconds until 7 days of
      age, and the sensor was changed one time when the patient reached three to four days of age
      per the company's recommendation. There were no restrictions on positioning or handling of
      neonates; nurses re-positioned neonates every 3-6 hours per unit protocol to prevent skin
      pressure injuries. Researchers, staff, and parents were blinded to RrSO2 values.
    

Intervention name(s): Near Infrared Spectroscopy
Intervention type(s): Device
Intervention description(s): Application of regional NIRS sensors to brain and kidney sites in the first 48 hours after birth to monitor regional tissue oxygenation for the first 7 days of age.
Other intervention name(s): NIRS
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Preterm infants that are less than 32 weeks, admitted to Unity Point Health(UPH) Meriter
        Newborn Intensive Care Unit (NICU) with application of NIRS by 48 hours of age.
      
Keywords: Near Infrared Spectroscopy; Creatinine; Urine Output
Marimastat or No Further Therapy in Treating Women With Metastatic Breast Cancer That Is Responding or Stable Following Chemotherapy
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Marimastat may stop the growth of breast cancer by stopping blood flow to the
      tumor. It is not known whether chemotherapy is more effective with or without marimastat for
      breast cancer.

      PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of marimastat
      with that of no further therapy in treating women who have metastatic breast cancer that is
      responding or stable after chemotherapy.
    

Detailed description: 
      OBJECTIVES: I. Determine whether marimastat prolongs progression-free survival in women with
      metastatic breast cancer who have responding or stable disease after receiving standard
      systemic chemotherapy. II. Determine the toxic effects of marimastat compared with placebo in
      patients with metastatic breast cancer who have responding or stable disease after receiving
      standard systemic chemotherapy. III. Determine whether there is an association between trough
      marimastat concentration and time to disease progression and toxicity.

      OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are
      stratified by the number of involved disease sites at study entry, prior chemotherapy for
      metastases, osseous disease only at study entry, and bisphosphonate therapy at study entry,
      and concurrent hormonal therapy (yes vs no). Patients are randomized into two groups.
      Patients take either marimastat or placebo, one capsule orally twice a day, approximately
      every 12 hours (i.e., during or after breakfast and dinner). The drug or placebo is given
      until the development of progressive disease or prohibitive toxicity.

      PROJECTED ACCRUAL: A total of 334 patients will be accrued for this study over 2 years.
    

Intervention name(s): marimastat
Intervention type(s): Drug
Intervention MeSH terms: Marimastat
Allocation: Randomized
Primary purpose: Treatment
Keywords: recurrent breast cancer
CICATRIX in the Treatment of Hypertrophic Scars and Keloids Scars
Condition: Hypertrophic Scars; Keloids
MeSH terms: Keloid; Cicatrix; Hypertrophy; Cicatrix, Hypertrophic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess the efficacy of CICATRIX (Asian Gotu Kola or Pennywort)
      usage in the treatment of Hypertrophic scars and keloids. The duration of this double-blind
      placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number of persons
      to be recruited and randomized for the study is 90.
    


Intervention name(s): Cicatrix; Placebo
Intervention type(s): Other; Other
Intervention description(s): Dosage commensurate with surface to be treated. After washing and drying the affected area, a thin layer of CICATRIX (Topical use) will be applied on the scar rubbing in different directions for 2 minutes, three times a day, for 12 weeks.; Dosage commensurate with surface to be treated. After washing and drying the affected area, a thin layer of PLACEBO (Topical use) will be applied on the scar rubbing in different directions for 2 minutes, three times a day, for 4 weeks.
Other intervention name(s): Cosmetic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hypertrophic scars; Keloids; Asian Gotu Kola; Asian Pennywort
Neurosteroids as Novel Therapeutic Agents for Chronic Pain in OEF/OIF Veterans
Condition: Lower Back Pain
MeSH terms: Chronic Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The study design is a randomized, double-blind, two-arm trial of pregnenolone and placebo to
      determine the possible analgesic effects in OEF/OIF Veterans with chronic low back pain. The
      total study duration is 6 weeks (followed by two-follow up phone calls). All patients will
      monitor pain symptoms for one week with pain diaries, followed by a 1-week placebo-only
      lead-in period, 90 subjects will be randomly assigned to one of two groups. Of these
      subjects, 45 subjects will receive pregnenolone, and 45 subjects will receive placebo for 4
      weeks. Patient interview assessments and laboratory studies will be performed at each
      interview time point. Pregnenolone, allopregnanolone and other neurosteroid metabolites will
      be determined by gas chromatography / mass spectrometry (GC/MS), proceeded by high
      performance liquid chromatography (HPLC).
    


Intervention name(s): Pregnenolone; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pain; pregnenolone; Veterans; clinical trial; neurosteroid; allopregnanolone; low back; placebo controlled; randomized; musculoskeletal
Multiple Dose Safety and Efficacy of LKA651 in Patients With Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objectives of this study were to evaluate the safety and efficacy of LKA651 in
      patients with macular edema from diabetic macular edema (DME),
    

Detailed description: 
      This study was a 3-arm, parallel group, randomized, patient- and investigator-masked trial
      planned in 90 patients with Diabetic macular edema (DME). The study consisted of a screening
      period of 60 days, main study (12 weeks), and an extension period (12 weeks). The study was
      stratified such that sentinel safety cohorts were first enrolled to test the safety of the
      combination of LKA651 and Lucentis before proceeding with further patient randomization.
      After determination of safety from Day 15 data from each sentinel cohort, patients were
      enrolled into 1 of 3 arms: LKA651 monotherapy, LKA651 plus Lucentis, and Lucentis
      monotherapy. Every patient was dosed 3 times in 4 week intervals in the treatment phase and
      was then followed up for an extension phase of an additional 12 weeks during which Lucentis
      was allowed to be administered as rescue at the discretion of the Investigator. No predefined
      rescue criteria were outlined as guidance.
    

Intervention name(s): LKA651; Lucentis
Intervention type(s): Drug; Drug
Intervention description(s): LKA651 5 mg Intravitreal injection, every 4 weeks for 12 weeks in the treatment phase; Lucentis 0.3 mg (U.S. sites) or 0.5 mg (ex U.S. sites) Intravitreal injection, every 4 weeks for 12 weeks in the treatment phase
Intervention MeSH terms: Ranibizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Macular degeneration; age-related macular degeneration (ARMD); vision loss; macula damage; retina damage; dry macular degeneration; wet macular degeneration; AMD; diabetic macular edema; DME; neovascular age-related macular degeneration; nAMD; retinal vein occlusion; RVO; Diabetic Macular edema (DME); macular edema; diabetic retinopathy; LKA651; Lucentis
Linking Obesity and Estrogen-responsive Genes in Endometrial Cancer
Condition: Endometrial Cancer
MeSH terms: Endometrial Neoplasms; Obesity
Study type: Observational

Summary: 
      The objective is to develop an organotypic model to assess the effects of obesity on the
      expression and methylation status of estrogen-responsive genes in endometrial cancer. Omental
      fat samples will be removed from participants during surgery and these fat samples will be
      used in laboratory analyses.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        12 female patients undergoing surgery for pre-existent conditions will be recruited for
        this study. The groups will include 6 patients with a BMI < 30 kg/m2 and 6 patients with a
        BMI ≥ 35 kg/m2. In addition 4 males patients will be recruited to assess responses from
        patients with low levels of serum estradiol.
      
Biospecimen description: 
      Omental fat samples will be stored for one year for study purposes. They will not be stored
      for future research
    
Keywords: Endometrial cancer; Obesity
LCS16 vs. COC User Satisfaction and Tolerability Study
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate user satisfaction in young nulliparous and parous women (18-29 years of age
      [inclusive]), using LCS16 compared to a COC over a period of 12 months.
    


Intervention name(s): Levonorgestrel (Kyleena, BAY86-5028); Ethinyl estradiol and drospirenone (Yarina, BAY86-5131)
Intervention type(s): Drug; Drug
Intervention description(s): Low-dose LNG IUS with an initial in vitro release rate of 16 μg LNG/day, used continuously. The total LNG content in LCS16 is 19.5 mg. Administered intrauterine, for 12 months with an option for extended use for up to 5 years; COC tablet containing 30 μg ethinyl estradiol and 3 mg drospirenone (taken on cycle days 1-21, inclusive, followed by a 7-day tablet-free week) for 12 months
Intervention MeSH terms: Drospirenone; Levonorgestrel; Ethinyl Estradiol; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intrauterine; Birth control
Biomarkers to Measure Treatment Response for Alcohol Dependence
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      The purpose of the research study of the K23 award is to develop a blood test that can check
      how much alcohol a person has consumed in the past few days. We will enroll heavy social
      drinkers who do not have alcohol-related problems but used to drinking 5 or more beers on a
      single occasion. Both men and women between ages 21 and 65 years can join the study. All
      participants must be of European decent.
    


Intervention name(s): Alcohol administration; Placebo administration
Intervention type(s): Other
Intervention description(s): consumption of 3 alcohol doses (2 regular and one placebo) each within 2h on separate days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: healthy volunteers; social drinkers; alcohol
Nerve-sparing, Robot-assisted Radical Prostatectomy Using a Personalized, 3D-printed Prostate Model for Selective Resection of Positive Surgical Margins
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      To optimize precision for secondary resection (SR) in frozen section (FS) controlled
      nerve-sparing robot-assisted radical prostatectomy (NS-RARP) by using a personalized
      3D-printed prostate model.
    

Detailed description: 
      Background:

      Nerve-sparing (NS) robot-assisted radical prostatectomy (RARP) offers optimized oncological
      and functional outcomes and has become the preferred minimally-invasive approach when
      available. To maximize oncologic safety in NS-RARP, a frozen section (FS) can be used but
      does not provide a visual impression of the positive surgical margin (PSM) to guide secondary
      resection (SR).

      Objective:

      To optimize precision for secondary resection (SR) in frozen section (FS) controlled
      nerve-sparing robot-assisted radical prostatectomy (NS-RARP) by using a personalized
      3D-printed prostate model.

      Design, setting and participants:

      100 patients with NS-RARP performed between September 2018 and August 2021 were included in
      this prospective multicenter cohort study.

      Interventions:

      A prostate model was 3D printed from preoperative pelvic MRI data and used during surgery to
      mark a PSM and guide SR.

      Outcome Measurements and statistical analysis Endpoints were comparison of the primary
      surgical margin status in the FS with the tissue of the resulting SR and with the final
      surgical margin status. Secondary parameters for oncological and erectile outcomes were
      assessed before and one year after surgery.
    

Intervention name(s): 3D model guided secondary resection
Intervention type(s): Procedure
Intervention description(s): A prostate model was 3D printed from preoperative pelvic MRI data and used during robot-assisted radical prostatectomy to mark a positive surgical margin and guide secondary resection.
Intervention model: Single Group Assignment
Intervention model description: Cohort Study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prostatectomy; nerve sparing; 3D model; urology; frozen section