bioihbjkbjnl/mcl2 huggingface dataset:
Sexual Function Screening in Childhood Cancer Survivors
Condition: Childhood Cancer; Survivorship; Sexual Dysfunction
Study type: Observational

Summary: 
      This is a qualitative research study involving semistructured interviews and Think-Aloud
      methodology during completion of a clinical screening tool. All participants will undergo the
      same semistructured interviews.
    

Detailed description: 
      The proposed research will explore patient-centered approaches to evaluating younger
      Adolescent/young adult Childhood cancer survivors for sexual dysfunction, including
      strategies for implementation and usability of thePatient-Reported Outcomes Measurement
      Information® v2.0 Brief Profile for Sexual Function and Satisfaction Brief, an existing adult
      screening tool. This study will include interviews with 24 patients age 15-24 who were
      diagnosed with cancer prior to age 18, and treated with chemotherapy, radiation and/or
      surgery and are now at least two years off therapy.
    

Intervention name(s): Interviews
Intervention type(s): Other
Intervention description(s): Participation will serve as verbal consent.
Qualitative PRA will call participant to schedule either phone or in person interview. If via phone, the study PRA performing the interview, will remind them to find a private space to speak.
REDCap link will be sent for PROMIS SexFS Brief.
PRA will perform semistructured interview and guide Think-Aloud to complete the PROMIS SexFS Brief.
Participants will not submit responses to PROMIS SexFS Brief responses after completing the tool.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        -  Sample size

               -  Max number of participants that can be enrolled is 30

               -  Max number of participants that can be interviewed is 24

          -  Gender Male and Female

          -  Age Range 15-24

          -  Demographic group English-speaking

          -  General health status Pediatric cancer survivors (diagnosed at <18 years of age and
             now at least 2 years off therapy)

          -  Geographic location Children's Hospital Colorado and University of Colorado Hospital
Web-based Personal or Peer Group Weight Management Study
Condition: Overweight and Obesity; Cardiovascular Risk Factors; Quality of Life; Work Ability
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The PERGROUP trial aims to investigate whether Web-based personal or Web-based group
      counselling weight management program can help to achieve lifestyle changes needed for weight
      loss and improvement in quality of life and cardiovascular risk factors. The control group is
      the traditional nurse-lead weight management group counselling.
    

Detailed description: 
      In this study, efficacy of two web-based weight management systems will be compared to a
      traditional nurse-lead sessions for weight management.

      Ten nurse-lead group counselling sessions lasting 90 minutes each will be conducted in three
      groups of 10-14 participants. Each session comprise education about healthy diet,
      psychoeducation and discussions.

      The web-based group counselling program offers informative weight management system with
      peer-based conversation possibility. Three groups of 10-14 participants who gather together
      for three nurse-lead sessions in the weeks 0, 5, and 12. The web-based program can be used
      for a year.

      The web-based personal counselling program offers informative weight management system with
      conversation possibility with the nurse for 12 weeks. Altogether 37 participants are enrolled
      and they can use the web-based weight management system for one year.

      In each intervention arm, intervention and counselling provided by the study nurses last for
      three months. Among all participants, weight loss, cardiometabolic data, information of
      lifestyle and quality of life will be measured at baseline, after the nurse-lead intervention
      (three months) and 12 months from the baseline.
    

Intervention name(s): Weight management
Intervention type(s): Behavioral
Intervention description(s): Please see the arm descriptions.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Clinical Investigation to Assess the Acid Neutralisation Activity of a Calcite Chewing Gum
Condition: Esophagitis; Gastro Oesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis; Esophagitis, Peptic
Study type: Interventional

Summary: 
      This investigation is designed to evaluate the acid neutralisation action of a new test
      product versus unmatched placebo.
    

Detailed description: 
      The primary objective of this confirmatory clinical investigation is to evaluate the acid
      neutralisation action of a calcite chewing gum, by comparing the antacid action with an
      unmatched placebo chewing gum. The clinical investigation will also assess the efficacy and
      safety of the calcite chewing gum.
    

Intervention name(s): Calcite chewing gum; Unmatched Placebo chewing gum
Intervention type(s): Device; Device
Intervention description(s): The calcite chewing gum is administered as two pieces of gum in a single dose, 30 minutes following the consumption of a refluxogenic meal.; The placebo chewing gum is administered as two pieces of gum in a single dose, 30 minutes following the consumption of a refluxogenic meal.
Intervention MeSH terms: Calcium Carbonate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This clinical investigation is being conducted to characterise the acid neutralisation activity of the test product, a calcite chewing gum, by comparing the antacid action with an unmatched placebo chewing gum. In this clinical investigation, the test product's ability to increase the pH within the oesophagus will be evaluated against an unmatched placebo.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastro-oesophageal reflux disease
Transcutaneous Electrical Nerve Stimulation With Frequency Specific Microcurrent Resonance Therapy for Non Specific Chronic Low Back Pain Patents: a Prospective Double Blinded, Randomized, Placebo Control Trial
Condition: Non Specific Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Transcutaneous electrical nerve stimulation (TENS) is widely used for chronic pain. Recent
      studies showed frequency-specific microcurrent (FSM) resonant therapy was safe and effective
      in patients with non-specific chronic low back pain. However, there was no prospective,
      double-blinded randomized controlled trial to validate the clinical applicability. The goal
      of this trial is to verify safety and efficacy of FSM using a TENS device, Dragon Waves
      Resonant Home Care Electronic Nerve Stimulator-DW1330,(Taiwan Resonant Waves Research Co,
      Taiwan R.O.C), in 60 patients with non-specific low back pain.
    

Detailed description: 
      Several studies showed that frequency-specific microcurrent (FSM) resonance therapy delivered
      by transcutaneous electrical nerve stimulation (TENS) device is safe and effective in
      patients with non-specific low back pain. The regiment of variable-frequency combination
      (1-10000 Hz or 1-20000 Hz), continuous use for 36-60 mins per day and 30 to 180 days per
      session has been proven to be safe. To validate the clinical applicability of FSM by using a
      TENS device, DW-1330 (Taiwan Resonant Waves Research Co., Taiwan R.O.C.), a prospective,
      randomized, double-blinded trial is proposed. Investigators are going to recruit 60 patients
      with non-specific low back pain for at least 3 months. Clinical assessments include Numerical
      Rating Scale (NRS), Oswestry Disability Index (ODI), EuroQol instrument (EQ-5D), Pressure
      pain threshold (PPT), and Heart rate variability (HRV). The 60 patients were double-blinded,
      1:1:1-randomly-distributed into 3 groups using different variable-frequency combinations: (1)
      Variable-frequency combination 1 (2) Variable-frequency combination 2 (3) Control(Placebo).
      During the surveillance period, a total of 2 visits and a telephone follow-up is set at Time
      point = 0, 2(telephone) and 4 week after recruitment. The primary endpoint is the change of
      NRS. The secondary endpoint is change of Heart rate variability (HRV). The safety evaluated
      index is the adverse event rate for all 3 groups.
    

Intervention name(s): Transcutaneous electrical nerve stimulation with frequency-specific microcurrent resonant therapy
Intervention type(s): Device
Intervention description(s): Transcutaneous electrical nerve stimulation with frequency-specific microcurrent resonant therapy using (Dragon Waves Resonant Home Care Electronic Nerve Stimulator (DW-1330), Taiwan Resonance Wave Research Co., Taiwan R.O.C,)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Transcutaneous electrical nerve stimulation; non specific chronic low back pain
Long-term Study Of Ropinirole In Restless Legs Syndrome
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an initial placebo-controlled study followed by open treatment evaluating the
      effectiveness and tolerability of ropinirole long-term in patients with moderate to severe
      Restless Legs Syndrome.
    

Detailed description: 
      A randomised, double-blind, placebo-controlled, parallel group study to evaluate the efficacy
      and safety of ropinirole for 26 weeks and to further evaluate the incidence of augmentation
      and rebound for a further 40 weeks open-label extension treatment period in subjects
      suffering from moderate to severe Restless Legs Syndrome.
    

Intervention name(s): Placebo; Ropinirole
Intervention type(s): Drug; Drug
Intervention description(s): Matching Placebo; Ropinirole IR 0.25mg/day to 4mg/day for RLS
Intervention MeSH terms: Ropinirole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Moderate; Restless Legs Syndrome; Severe; ropinirole
Safety and Efficacy of IM Injections of PLX-PAD for the Regeneration of Injured Gluteal Musculature After Total Hip Arthroplasty
Condition: Total Hip Arthroplasty; Muscle Injury
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Local administration of PLX-PAD single dose, intra-muscular injection for the regeneration of
      injured gluteal musculature after Total Hip Arthroplasty (THA).
    

Detailed description: 
      One of the main problems when performing THA via the standard transgluteal approach is the
      necessary injury of the gluteus medius muscle. The consecutive decrease of contractile muscle
      substance and the substitution by scar tissue leads to functional deficits of the
      pelvic-stabilizing musculature with an insufficiency limp in a large number of patients. In
      the long run the lack of musculature leads to a decrease in bone substance at the insertion
      sites of the gluteal muscles of the proximal femur. The present study has the aim of
      establishing a new therapy for iatrogenic gluteal muscle damage. The hypothesis of the
      present proposal is that intra-muscular (IM) injection of PLX-PAD into the iatrogenically
      injured gluteus medius muscle after THA results in an improved regeneration of the skeletal
      muscle tissue and consecutively in an improved functional outcome.

      Subjects will be assigned to receive one of the two targeted doses of PLX-PAD or placebo. On
      the treatment day, after suturing the gluteus medius muscle PLX-PAD or placebo will be
      applied directly to the site of laceration.

      Patients will be followed up for efficacy assessment up to week 26 and for safety assessment
      (Adverse events, vital signs, ECG, routinf lab and immunological testing) up to week 52 after
      THA. Patients will be phoned at week 104 in order to inquire about the occurence of new
      cancer.
    

Intervention name(s): 150M PLX-PAD; 300M PLX-PAD; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Single course, multiple IM injections; Single course, multiple IM injections; Single course, multiple IM injections
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: THA; Muscle injury
Eye Drops for Early Morning-Associated Corneal Swelling of the Cornea
Condition: Fuchs' Endothelial Dystrophy
MeSH terms: Fuchs' Endothelial Dystrophy
Study type: Interventional

Summary: 
      This study evaluates the efficacy of hyperosmolar eye drops on early morning edema of the
      cornea in patients with Fuchs' endothelial corneal dystrophy (FECD). Each participant will
      receive hyperosmolar eye drops in one eye and lubricating eye drops in the fellow eye.
    

Detailed description: 
      Hyperosmolar eye drops are lubricating eye drops with 5% of sodium chloride. Hyperosmolar eye
      drops are thought to temporarily deswell the cornea.

      During morning hours, patients with Fuchs' endothelial corneal dystrophy (FECD) typically
      report poor vision and disturbing glare because of corneal edema. To improve vision in
      advanced stages of the disease, corneal endothelial transplantation has become the treatment
      of choice. Many patients with Fuchs' endothelial corneal dystrophy (FECD) use hyperosmolar
      eye drops before transplantation. At present, it is unclear, how much hyperosmolar eye drops
      help reducing corneal edema in Fuchs' endothelial corneal dystrophy (FECD). Based on our
      previous work that determined the amount of additional corneal edema in the morning in
      patients with Fuchs' endothelial corneal dystrophy (FECD), the investigators will assess if
      hyperosmolar eye drops speed up the deswelling process.
    

Intervention name(s): Hyperosmolar eye drops; Placebo
Intervention type(s): Other; Other
Intervention description(s): Application of one preservative-free hyperosmolar eye drop, when waking up and one eye drop 30 min later to one eye by the investigators; Application of one preservative-free lubricating eye drop, when waking up and one eye drop 30 min later to the fellow eye by the investigators
Other intervention name(s): ODM 5 (CE0459); Placebo (for hyperosmolar eye drops)
Intervention MeSH terms: Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study uses both eyes of the participant to allow inter- and intraindividual comparisons. One eye will be randomized to be treated with hyperosmolar eye drops, the fellow eye will be treated with lubricating eye drops.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Corneal edema; Descemet membrane endothelial keratoplasty (DMEK); Hyperosmolar eye drops
Heart Map Study -Determination of Myocardial Relaxation Times Values in Healthy Volunters
Condition: Normal Myocardial T1, T2 and T2* Values
Study type: Interventional

Summary: 
      T1, T2 and T2* relaxation times, as determined with cardiac MRI, are markers of myocardial
      tissue content (water, fibrosis, iron).

      The aim of study is to determine the normal values of T1, T2 and T2* relaxation times in
      healthy volunters aged 18-69 years using 1.5T clinical MRI.
    

Detailed description: 
      Cardiac MRI is more and more used in patients with ischaemic and non-ischaemic heart
      diseases. One major strength of MRI is its great potential for tissue characterization.

      For early detection and follow-up of patients with hemosiderosis, who are at high risk of
      myocardial iron overload, cardiac MRI seems to be the most reliable, more reproducible and
      less invasive method. In addition MRI does not require injection of contrast media. It is
      commonly accepted that myocardial T2 * value of less than 20 ms corresponds to iron overload
      in the myocardium. However, this value is based on a small sample study and nomogram based on
      age were not published. The determination of normal values in a population of healthy
      controls according to age appears to be a prerequisite for reliable interpretation of imaging
      data.

      Moreover, myocardial edema and fibrosis are more and more evaluated with cardiac MRI using T1
      and T2 myocardial relaxation times. As for T2* values, normogram of T1 and T2 values based on
      age were not published.

      The increasing use of T1, T2 and T2* mapping sequences in clinical practice for tissue
      characterization of the myocardium justify the implementation of a study in healthy
      volunteers to determine normograms based on age.
    

Intervention name(s): Magnetic Resonance Imaging
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: normal myocardial T1, T2 and T2* values
Comparison of Different Doses of Oestrogen Therapy for Preventing Intrauterine Adhesion
Condition: Asherman Syndrome
MeSH terms: Gynatresia; Tissue Adhesions
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This single-center,prospective,randomized,controlled trial is conducted to evaluate the
      efficacy of different doses of estrogen artificial periodic therapy after hysteroscopic
      adhesiolysis in patients with moderate-severe adhesion.
    


Intervention name(s): Femoston
Intervention type(s): Drug
Intervention description(s): Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Intrauterine Adhesion; Oestrogen Artificial Periodic Therapy
Calcium and Gut Hormones
Condition: Obesity; Diabetes
Study type: Interventional

Summary: 
      Gut hormones have therapeutic potential in the prevention and treatment obesity and type 2
      diabetes (T2D). Rodent evidence suggests that calcium may stimulate gut hormone secretion.
      Evidence in humans however, is lacking. This study aims to assess whether the calcium
      ingestion stimulates gut hormone availability in humans.
    


Intervention name(s): Control; Milk mineral supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Water with 80 mg sucralose; Water with milk mineral supplement (1000 mg calcium), plus 80 mg sucralose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Selective Dentine Removal in Primary Teeth
Condition: Caries, Dental
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      Background There is little information regarding the longevity of the restored tooth,
      considering the health of the pulp-dentine complex, in children who do not sufficiently
      cooperate with dental treatment.

      Aim To evaluate the longevity of primary molar teeth with an occluso-proximal cavity that was
      treated with the selective removal of carious tissue.

      Design A total of 150 children were allocated to two parallel groups: group 1 (G1, n = 70,
      control, Ketac Molar Easymix®, 3M/ESPE, Seefeld, GE) and group 2 (G2, n = 80, test, Maxxion®,
      FGM, Joinville, BR). The study was double-blinded, and an operator specialized in paediatric
      dentistry performed the selective removal of soft dentine and the restoration of the cavity
      with GIC. During the follow-up periods, the teeth were evaluated via periapical radiography
      by two trained examiners specialized in radiology. Statistical analysis was performed using
      Stata 11.2 software (StataCorp, Texas, USA) and a survival curve (Kaplan-Meier).
    


Intervention name(s): Selective removal of carious tissue and restoration with Maxxion; Control
Intervention type(s): Procedure; Procedure
Intervention description(s): Molars subjected to selective removal and restored with Maxxion; Molars subjected to selective removal and restored with Ketac Molar Easymix
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A total of 150 children were allocated to two parallel groups: group 1 (G1, n = 70, control, Ketac Molar Easymix®, 3M/ESPE, Seefeld, GE) and group 2 (G2, n = 80, test, Maxxion®, FGM, Joinville, BR). The study was double-blinded, and an operator specialized in paediatric dentistry performed the selective removal of soft dentine and the restoration of the cavity with GIC. During the follow-up periods, the teeth were evaluated via periapical radiography by two trained examiners specialized in radiology. Statistical analysis was performed using Stata 11.2 software (StataCorp, Texas, USA) and a survival curve (Kaplan-Meier).
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: minimally invasive dentistry; dental caries; dentine
12- Week Open Label Treatment of Refractory Bipolar Depression
Condition: Bipolar Disorder
MeSH terms: Depression; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      1. Determine the change in symptomatology and function in refractory bipolar depression,
           when treated with combination of DEP+AZP for a period of 12 weeks

        2. Determine the tolerability and safety of AZP added to DEP in the treatment of refractory
           bipolar depression
    

Detailed description: 
      )Determine the change in symptomatology and function in refractory bipolar depression, when
      treated with combination of DEP+AZP for a period of 12 weeks

      2) Determine the tolerability and safety of AZP added to DEP in the treatment of refractory
      bipolar depression
    

Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention description(s): Aripiprazole5mg - 30mg, every day (QD), for 12 weeks.
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bipolar Depression; Refractory