bioihbjkbjnl/mcl2 huggingface dataset:
Single Center Randomized Pilot Study Of Colorectal Cancer Screening Outreach
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      A four arm randomized pilot study to assess if the rate of completion of Fecal Immunochemical
      Test is increased by the addition of financial incentives.
    

Detailed description: 
      This is a single center 4-arm randomized pilot study to assess if the rate of completion of
      Fecal Immunochemical Test (FIT) is increased by the addition of financial incentives.
      Potentially eligible subjects will be identified via a data abstraction by Penn Data Store.
      We will conduct Electronic Medical Record (EMR) reviews on randomly select patients from the
      data abstraction using PennChart to confirm eligibility until 1,080 patients are identified.
      We will then randomize these 1,080 patients to one of four arms during the intervention
      phase.

        -  Arm 1: mailed FIT kit (usual care)

        -  Arm 2: mailed FIT kit + a gift card included in mailing (unconditional fixed incentive)

        -  Arm 3: mailed FIT kit + guarantee of receiving a gift card if kit is returned within two
           months (conditional fixed incentive)

        -  Arm 4: mailed FIT kit + entry in a 1/10 chance lottery to receive a gift card if kit is
           returned within two months (conditional lottery incentive) All 1,080 subjects will
           receive the mailed FIT kit. Subjects whose FIT results are not recorded in PennChart
           will receive a follow-up phone call via Interactive Voice Response (IVR) three weeks
           after the kit was mailed to the subject. Subjects whose FIT results are not recorded in
           PennChart will receive a follow-up mailed reminder six weeks after the kit was mailed to
           the subject. Subjects will receive follow-up regardless of the arm to which they are
           randomized.

      A random sub-sample of 200 subjects will be called at least twelve weeks after the kit was
      mailed to the subject to complete a questionnaire. Verbal consent will be obtained from this
      sub-sample. This phone call will occur after the intervention and follow-up phases are
      completed. Analysis will occur after the sub-sample questionnaire phase is completed.
    

Intervention name(s): Financial Incentive
Intervention type(s): Other
Intervention description(s): Financial incentives provide small immediate and tangible rewards that are aligned with the abstract long-term rewards of cancer prevention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Screening
Ginkgo Biloba Extract in the Treatment of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      We investigated the effects of Ginkgo biloba extract on the symptoms and cognitive
      functioning in patients with schizophrenia
    

Detailed description: 
      Objective: This study aimed to evaluate the effect of Ginkgo biloba extract in the treatment
      of symptoms and cognitive functioning in 200? chronic patients with schizophrenia

      Methods:

        1. Clinical Trial: This is a randomized, double-blind and parallel controlled trial in the
           chronic patients with schizophrenia. The study consists of 12 weeks of double-blind
           treatment.

        2. Assessment Procedures:

      2.1 Primary Outcome Variable: Patients were assessed by two clinical trained staff, who were
      blind to the treatment protocols, by using the Positive and Negative Syndrome Scale (PANSS)
      to assess the psychopathology and Repeatable Battery for the Assessment of Neuropsychological
      Status (RBANS) to evaluation the cognitive functioning. Patients were interviewed at
      screening, and at baseline, 4? weeks, 12? weeks.

      2.2 Side effects: The side effect rating scale (UKU) was used to assess the side effect at
      baseline, 4? weeks, and 12? weeks.

      2.3 Weight gain measurement: weigh was measured every week.
    

Intervention name(s): Ginkgo Biloba Extract; Placebo oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): Ginkgo biloba extract with 360mg was administered; Placebo with nine tables was administered
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: schizophrenia; Ginkgo biloba extract; cognition
A Study to Evaluate Whether Losartan Protects the Kidney in Hypertensive Diabetic Participants With Microalbuminuria (MK0954-365 AM1)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      This study will evaluate whether losartan protects the kidney in hypertensive Type II
      diabetic participants with microalbuminuria.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adult participants with diabetes mellitus and hypertension treated with losartan 50 mg or
        100 mg for at least 6 months in a hospital setting in Taiwan
Assessment of the Effects of Enclomiphene Citrate on Bone Mineral Density in Men With Secondary Hypogonadism
Condition: Effect of Treatment on Bone Mineral Density
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the effects of 12 months of treatment with Androxal on bone mineral density in
      men with secondary hypogonadism.
    

Detailed description: 
      This study is a phase III single-blind placebo-controlled safety study with a 52 week active
      dosing period with Androxal. Safety will be assessed by physical and visual acuity exams,
      slit lamp and fundoscopy eye exams, clinical laboratory tests, DEXA scanning, lean soft
      tissue assessment (LST), and adverse event reporting. Results will be compared to an
      age-matched placebo group.
    

Intervention name(s): enclomiphene citrate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 12.5 mg, 1 capsule, daily, oral. After 6 weeks of treatment, subjects will remain on 12.5 mg/day if their morning testosterone level is greater than 300 ng/dL. If a subject's testosterone is less than 300 ng/dL, the subject's dose will be increased to 25 mg/day; 1 placebo capsule per day, oral
Other intervention name(s): Androxal
Intervention MeSH terms: Enclomiphene; Clomiphene; Zuclomiphene
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic ACL Surgery
Condition: ACL Injury; Postoperative Pain
MeSH terms: Pain, Postoperative; Anterior Cruciate Ligament Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      1. The investigators aim to examine the use of IV and oral ketorolac as an adjunctive agent
           to the standard of care pain protocol for postoperative pain control following ACL
           reconstruction surgery.

        2. The investigators hypothesize that the use of IV and oral ketorolac in addition to the
           standard of care pain protocol will reduce postoperative opioid consumption following
           ACL reconstruction surgery.
    


Intervention name(s): Ketorolac; Oxycodone-Acetaminophen
Intervention type(s): Drug; Drug
Intervention description(s): Oral ketorolac for pain control following ACL reconstruction surgery; Oral oxycodone-acetaminophen for post-operative pain control
Intervention MeSH terms: Acetaminophen; Ketorolac; Acetaminophen, hydrocodone drug combination; Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ACL reconstruction; Ketorolac; Pain; Narcotic
Percutaneous Pin Removal in Children - is Analgesia Necessary?
Condition: Elbow Fracture
MeSH terms: Elbow Fractures
Study type: Interventional

Summary: 
      This is a simple randomised clinical trial to study if non-narcotic analgesia reduces the
      pain score and pulse rate of children who undergo removal of percutaneous pins in the
      outpatient clinic.

      Inclusion criteria:

        -  5-12 years of age

        -  2 or 3 percutaneous pins in either elbow

      Exclusion criteria:

      - documented or suspected allergies to acetaminophen, ibuprofen

      Patients enrolled in the study are instructed not take additional analgesia prior to the
      clinic visit (risk of overdosage explained). This is verified by clinic nurses conducting the
      trial.

      At the clinic visit, they are randomized into one of three groups

      1. acetaminophen; 2. ibuprofen; or 3. Vitamin C (Placebo).

      They are served the 'medication' (weight-appropriate dose) and the pins are removed in the
      clinic an hour later.

      Pain score (Wong-Baker scale) and pulse rate are measured before pin removal, immediately
      following pin removal, and 10 minutes after pin removal.

      The study hypothesis is that non-narcotic analgesia (such as acetaminophen and ibuprofen) do
      not decrease pain score and pulse rate associated with the pin removal procedure.
    

Detailed description: 
      See Brief Summary
    

Intervention name(s): Acetaminophen; Ibuprofen; Vitamin C
Intervention type(s): Drug; Drug; Other
Intervention description(s): Syrup; Syrup; Syrup
Other intervention name(s): Paracetamol; Tylenol; Brufen; Ascorbic Acid
Intervention MeSH terms: Acetaminophen; Ascorbic Acid; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: children; supracondylar fracture; pin removal; analgesia; pain score
Effect of Pregnancy on Androgenic Steroids in Different Genetic Panels
Condition: Sex Steroids
Study type: Interventional

Summary: 
      Androgens are important sex steroids in women. Androgens influence protein synthesis and
      muscle growth, are involved in maturation of the reproductive organs, have a fat reducing
      effect , have a negative effect on the serum lipid profile, and may also increase insulin
      resistance and coagulation activity. The role of androgens in women is not clear. This study
      is aimed at learning about the amount of androgen and its actions in pregnant women. This
      study is also looking to see if there are specific patient factors (such as genetics) that
      change the amount of androgen and its activity.
    

Detailed description: 
      There is a lot of information about the main female sex hormones such as estrogens and
      progesterones (the main female sex hormones and the most important in menstrual ,
      reproductive cycles and pregnancy) . However there is little information about androgens in
      pregnant women. It is known that certain illnesses, chemicals and dietary products might
      change the amount of androgen and its actions, which could affect the mother and her baby. It
      is also known that there are differences between the androgen levels in different people, and
      in different ethnic groups. These differences are mostly due to genetic factors. The goal of
      this study is to learn about the androgen levels in healthy pregnant women and if genetic or
      clinical factors (for example age, trimester of pregnancy, parity, ethnicity, etc.) play a
      role in changing the androgen amount and action, throughout pregnancy and after delivery.
    

Intervention name(s): Urine sample collection; Saliva collection
Intervention type(s): Biological; Biological
Intervention description(s): A urine sample will be collected in each of the 3 trimesters of pregnancy, and also at 6 weeks post partum.; A saliva sample will be collected at one time point during the study - likely at the initial baseline visit.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Activity and Metformin Intervention in Obese Adolescents
Condition: Obesity; Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the sustainability of a two-year intervention aimed at
      improving body mass index (BMI) and metabolic and vascular health in obese youth. The study
      will compare lifestyle changes with diet and exercise alone with changes in lifestyle in
      combination with metformin medication. An initial intensive exercise program will also be
      compared with a standard exercise program.

      Hypothesis: Metformin therapy in combination with intensive lifestyle intervention in obese
      children and adolescents will be associated with reduced rate of weight gain, improved BMI,
      body composition, physical activity, physical fitness, insulin sensitivity, blood lipid
      profiles, adipocytokines and vascular function.
    

Detailed description: 
      This study will assess the sustainability of a two-year intervention and the degree of
      improvement in body mass index (BMI) and reduction in risk factors for type 2 diabetes and
      diabetes related cardiovascular disease, as well as evaluating the additive effect of
      metformin (as GlumetzaTM 500 mg Extended Release Tablets) and comparing an initial intensive
      exercise program with a standard exercise program. The study will recruit obese youth who are
      at risk for type 2 diabetes and cardiovascular disease.
    

Intervention name(s): Metformin and standard exercise; Metformin Intensive exercise; Placebo Standard exercise; Intensive exercise
Intervention type(s): Drug; Drug; Behavioral; Behavioral
Intervention description(s): Metformin 1500 mg daily for 2 years; Metformin 1500 mg daily for 2 years; Standard exercise; Placebo Intensive exercise
Other intervention name(s): GlumetzaTM 500 mg Extended Release; GlumetzaTM 500 mg Extended Release
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Obesity; Metformin; Physical activity; Cardiovascular health
Use of Ibuprofen to Prevent IUD Site Effects
Condition: IUD Removal
Study type: Interventional
Phase: Phase 3

Summary: 
      This research will determine whether prophylactic use of ibuprofen can prevent common side
      effects of the copper intrauterine device (IUD) and prevent early removal of the device.
    

Detailed description: 
      Increased menstrual bleeding and pain are the primary side effects that lead to early removal
      of the copper intrauterine device (IUD). Ibuprofen and other nonsteroidal anti-inflammatory
      drugs are a proven treatment for such IUD-induced problems. This study will determine if
      prophylactic use of ibuprofen can improve continuation rates of the IUD.

      A total of 2,019 first-time IUD users were recruited in Chile for this double-blind,
      randomized, placebo-controlled trial. Half of the participants were given ibuprofen and
      instructions to take 1200 mg daily during menses (for up to 5 days each cycle) for the first
      six months of IUD use. The other half were asked to take an identical-appearing placebo in
      the same manner. The primary study endpoint was IUD removal within 12 months of insertion.
    

Intervention name(s): ibuprofen
Intervention type(s): Drug
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Prevention
Keywords: randomized controlled trial; prophylactic nonsteroidal antiflammatory drug; IUD removal
Abdominal Muscles Strengthening And Pelvic Floor Muscle Strengthening Exercises In Females With Urinary Incontinence
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      Urinary incontinence is common females., it badly affects their performance and result in
      psychosocial problems in addition to the barriers that already have been resulted from
      incontinence. This study combines simple regime of hip adductor a strengthening with pelvic
      floor muscles. The theme is to test if pelvic floor muscle training can be augmented by
      incorporating adductor muscle strengthening. If this comes out to be effective, this can be
      great contribution to gym doing females to improve their urinary incontinence related
      impairments. Woman would be encouraged to continue regular exercise. This will be randomized
      clinical trial. There are two groups for the compression of adductors strengthening and
      pelvic floor muscle strengthening.

      The collected data will be entered in SPSS 20.0, Descriptive and Inferential statists will be
      applied. Results and conclusion will be drawn.
    

Detailed description: 
      Urinary incontinence is common females., it badly affects their performance and result in
      psychosocial problems in addition to the barriers that already have been resulted from
      incontinence. This study combines simple regime of hip adductor a strengthening with pelvic
      floor muscles. The theme is to test if pelvic floor muscle training can be augmented by
      incorporating adductor muscle strengthening. If this comes out to be effective, this can be
      great contribution to gym doing females to improve their urinary incontinence related
      impairments. Woman would be encouraged to continue regular exercise. This will be randomized
      clinical trial. There are two groups for the compression of adductors strengthening and
      pelvic floor muscle strengthening.

      Group A: with pelvic floor muscle strengthening is strengthening. Group B: abdominal muscles
      strengthening exercises. The collected data will be entered in SPSS 20.0, Descriptive and
      Inferential statists will be applied. Results and conclusion will be drawn.
    

Intervention name(s): abdominal strengthening exercises; pelvic floor muscles strengthening exercises
Intervention type(s): Other; Other
Intervention description(s): abdominal strengthening exercises; to strengthen pelvic floor muscles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bladder neck mobility
Risk of Diabetes in Young Turner Syndrome Patients
Condition: Turner Syndrome
MeSH terms: Turner Syndrome; Gonadal Dysgenesis; Syndrome
Study type: Observational

Summary: 
      Turner Syndrome is a common genetic disorder. Seventy percent of adults with Turner Syndrome
      have abnormalities in glucose metabolism which can lead to diabetes. The current screening
      guidelines for diabetes in Turner Syndrome are not specific and involve a fasting blood sugar
      once a year. The objective of this study is to determine if there are abnormalities in
      glucose metabolism and pancreatic function in young girls with Turner Syndrome. The study
      hypothesis is that pancreatic dysfunction (specifically of the beta cells that make insulin)
      is more prevalent in girls with Turner Syndrome compared to healthy controls.
    

Detailed description: 
      The study will be conducted at Children's Hospital Medical Center, Cincinnati. The study will
      require 1 visit to the hospital where the subject will have an oral glucose tolerance test
      and a physical exam
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Primary Care Clinic Turner Syndrome Center of Cincinnati Community Sample
      
Biospecimen description: 
      Whole blood
    
Keywords: Turner Syndrome; Diabetes
Does the Message Matter? Enhancing Adherence in Healthcare Through Persuasive Messages
Condition: Appointment Reminders
Study type: Interventional

Summary: 
      In this research we propose to develop a comprehensive model to explain how users process
      persuasive messages. We then propose to experimentally test varying the persuasiveness of
      message content in various domains, and assess their impact on adherence by both physicians
      and patients. Finally based on our conceptual model and results from the experimental data we
      propose to develop preliminary guidelines to assist developers in designing effective
      messages.
    


Intervention name(s): Electronic reminder message
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Health Services Research
Use of an Intra Uterine Balloon to Prevent Recurrent Adhesions (REpAIR)
Condition: Adhesion; Uterus, Internal
MeSH terms: Tissue Adhesions
Study type: Interventional

Summary: 
      Patients suffering of subfertility as a consequence of intrauterine adhesions could be
      treated with hysteroscopic adhesiolysis. Adhesion recurrence may occur postoperative. An
      intrauterine balloon, inserted after hysteroscopic adhesiolysis, may prevent adhesion
      reformation.

      A Foley catheter can serve for this purpose, but its not ideal. COOK medical® developed a
      hearth shaped intrauterine balloon to reduce bleeding after intrauterine surgery.

      We aimed to perform a pilot study of 10 procedures with insertion of a hearth shaped
      intrauterine balloon as antiadhesion method subsequent to a hysteroscopic adhesiolysis, to
      study its feasibility in terms of surgeon's and patient's experience.
    


Intervention name(s): intra uterine Cook balloon
Intervention type(s): Device
Intervention description(s): Insertion of a hearth shaped intrauterine balloon immediately after hysteroscopic adhesiolysis and left in place for 7 days under antibiotic prophylaxis.
Intervention model: Single Group Assignment
Intervention model description: To evaluate the feasibility of a hearth shaped intrauterine balloon as antiadhesion method subsequent to a hysteroscopic adhesiolysis in terms of surgeon's and patient's experience.
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: antiadhesion treatment; Asherman's syndrome; hysteroscopic adhesiolysis; intrauterine adhesions; intrauterine balloon
Influence of Medication on Functional Connectivity
Condition: Prescription Drug Abuse (Not Dependent)
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study will assess the effects of acute low-dose opioid administration on functional
      neuroimaging measures in healthy individuals
    

Detailed description: 
      This study will assess the effects of acute low-dose opioid administration on functional
      neuroimaging measures in healthy individuals (N=40, 20 male, 20 female). The objective of
      this research is to develop an understanding of factors that may influence individual
      variability on resting state functional connectivity in response to low-dose opioid
      administration with the longer term aim of understanding addictions vulnerability.
      Specifically, the proposed pilot research will explore the effects of single dose of
      oxycodone (15mg) on resting state functional connectivity and other common neuroimaging
      measures (e.g., diffusion MRI, structural MRI).
    

Intervention name(s): Oxycodone Medication First; Placebo First
Intervention type(s): Drug; Drug
Intervention description(s): Participants will be given 15mg oxycodone one hour before fMRI scan. After at least 1 week wash out participants will be given placebo one hour before fMRI scan.; Participants will be given placebo one hour before fMRI scan. After at least 1 week wash out participants will be given 15mg oxycodone one hour before fMRI scan.
Other intervention name(s): Oxycodone; placebo
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science