bioihbjkbjnl/mcl2 huggingface dataset:
Tamoxifen in the Prevention of Breast Cancer in Hodgkin's Disease Survivors
Condition: Hodgkin's Disease; Breast Cancer
MeSH terms: Breast Neoplasms; Hodgkin Disease
Study type: Interventional

Summary: 
      The purpose of this study is determine whether or not tamoxifen reduces the chance of
      Hodgkin's Disease survivors developing breast cancer.
    

Detailed description: 
      -  Patients will receive tamoxifen orally once daily to be taken at home for 1 year. They
           will be asked to complete a daily drug log to keep track of the pills taken or missed.

        -  Patients will also be asked to give a blood/DNA sample which will be stored for possible
           further testing for the presence of cancer related genes that are known nor or
           discovered in the future.

        -  Patients will also receive a mammogram that will be reviewed by study officials.

        -  Side effects will be monitored every 2 months for one year, between visits to the
           clinic.

        -  A follow-up visit will be conducted at the 6 month mark and includes a physical exam,
           blood work, health and wellness surveys)

        -  A follow-up visit will be performed at the 1 year mark and includes a mammogram,
           gynecological exam, physical exam, blood work, health and wellness surveys.

        -  Patients active participation will be for 1 year. However, tamoxifen has been shown to
           be effective after a 5-year course in other women at increased risk for breast cancer,
           the patient may decide to stay on tamoxifen for 4 additional years.
    

Intervention name(s): Tamoxifen
Intervention type(s): Drug
Intervention description(s): Given orally, daily for one year.
Intervention MeSH terms: Tamoxifen
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hodgkin's disease; breast cancer prevention; tamoxifen
Real-time Monitoring of Motor Cortical Activity Induced by Low-frequency Repetitive Transcranial Magnetic Stimulation
Condition: Healthy
Study type: Interventional

Summary: 
      In this study, we investigated the effect of low-frequency repetitive trans cranial magnetic
      stimulation, one of the noninvasive brain stimuli, on the functional changes of the bilateral
      motor cortical activity in normal subjects using functional near infrared spectroscopy
      (fNIRS).
    

Detailed description: 
      In normal subjects,

        1. the effect of low-frequency repetitive transcranial magnetic stimulation on cerebral
           cortex are measured in real time using fNIRS.

        2. Changes in cerebral cortical activity before and after stimulation are measured using
           the motor function test and the motor-induced potential test
    

Intervention name(s): low frequency rTMS + Navigation System; only low frequency rTMS; Sham low frequency rTMS + Navigation System
Intervention type(s): Device; Device; Device
Intervention description(s): 1Hz low-frequency rTMS stimulation over primary motor area using navigation system; 1Hz low-frequency rTMS stimulation over primary motor area; 1Hz low-frequency sham rTMS stimulation over primary motor area using navigation system
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: low frequency rTMS; fNIRS; Hemodynamic Response; Non-invasive brain stimulation
Bioequivalence Study of Ribavirin in Healthy Adult Subjects Under Fed Condition
Condition: Healthy Subjects
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate and compare the relative plasma bioavailability and therefore the bioequivalence
      of two different immediate release products each containing Ribavirin 400 mg, after
      administering a single oral dose, to healthy adult subjects under fed conditions.
    

Detailed description: 
      Enrolled subjects were randomized in a two-phase, two-sequence, cross-over design to receive
      a single dose of the test product (T) or the reference product (R) each phase, under fed
      conditions, with a wash-out period of 42 days.

      Ribavirin plasma concentration was determined using a validated LC-MS-MS method, followed by
      Pharmacokinetics, and statistical analysis using Phoenix WinNonlin® software to determine the
      average bioequivalence.
    

Intervention name(s): Ribavirin 400 mg film coated tablet (1*400mg); Copegus® 200 mg film coated tablet (2*200mg)
Intervention type(s): Drug; Drug
Intervention description(s): an immediate release film-coated tablet containing 400 mg Ribavirin; an immediate release film-coated tablet containing 200 mg Ribavirin
Other intervention name(s): Test product (T); Reference product (R)
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A randomized, single-dose, two-way crossover, open-label, laboratory blind, bioequivalence study
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Bioequivalence; Randomized; Crossover; Ribavirin
The Effect of a Lumbar Rotational Spinal Mobilization Technique With Lumbar Disc Herniation
Condition: Lumbar Disc Herniation
MeSH terms: Intervertebral Disc Displacement; Hernia
Study type: Interventional

Summary: 
      The aim of this study was to research the effect of the Lumbar Spinal Rotational Mobilization
      technique on radiological findings, pain, disability and joint range of motion (ROM) in
      patients with lumbar disc herniation
    

Detailed description: 
      In our study, it was aimed to investigate the acute effect of Lumbar Rotational Spinal
      Mobilization Technique on radiological findings, pain, disability and range of motion in 26
      patients diagnosed with lumbar disc herniation(LDH) by magnetic resonance imaging(MRI) and
      physical examination. Disc height, herniation distance and facet joint distance of the
      patients were measured with MRI. Pain was assessed with the Visual Analogue Scale. Disability
      was measured with the Oswestry Low Back Pain Disability Questionnaire and Lumbar range of
      motion(ROM) was measured with a goniometer and tape measure. Rotational Spinal Mobilization
      Technique was applied to the patients in 2 sessions with a one-week interval, slowly and with
      30 repetitions in both directions. All assessments were repeated within 1 week after
      treatment. It was observed whether there was an improvement in terms of radiological, pain,
      disability and ROM in the patients. 2 months after the 2nd evaluation, other parameters
      except the radiological evaluation were reapplied and it was tried to determine whether the
      effect persisted.
    

Intervention name(s): The Lumbar Rotational Spinal Mobilization Technique
Intervention type(s): Other
Intervention description(s): Patients included in the study underwent the lumbar rotational spinal mobilization(LRSM) technique during two sessions per week. The LRSM technique is applied while patients are lying on their side. The uppermost hip and knee are placed in 90 degree flexion, this is to assist rotational stress, and the lower leg is placed in extension. The lower shoulder is strongly pulled; thus, the upper shoulder is positioned toward the posterior and the pelvis moves anteriorly. The clinician stands in front of the patient. They stabilize the upper shoulder with one hand, and place the palm of the other hand behind the hard part of the ilium wing, with forearm horizontal and fingers turned toward the clinician. A rotational force is applied with pressure in the horizontal direction by pulling the hand on the ilium toward the clinician. In this position, 30 slow repeated movements are performed. The same practice is performed on both sides
Intervention model: Single Group Assignment
Intervention model description: The research was designed as a semi-experimental study with pre-test (before implementation), post-test (after implementation) and 2-month follow-up assessments
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lumbar disc herniation; Manual therapy; Lumbar Spinal Rotational Mobilization
Polydeoxyribonucleotide -Placentex Mastelli(Pdrn) for the Treatment of Diabetic Ulcers
Condition: Diabetic Ulcer; Foot Ulcer Unhealed
MeSH terms: Foot Ulcer; Ulcer
Study type: Interventional
Phase: Phase 4

Summary: 
      The main objective of the study is to evaluate the efficacy of the polydeoxyribonucleotide in
      improving the healing of diabetic foot ulcers.
    

Detailed description: 
      This trial will involve diabetic patients with foot ulcers who meet the inclusion/exclusion
      criteria. At least 200 patients aged 45-80yrs will be enrolled in the study and randomly
      allocated to receive the active drug or the placebo in indistinguishable formulations. After
      2 months closure rate of the ulcer will be evaluated.
    

Intervention name(s): Polydeoxyribonucleotide; 0.9% NaCl
Intervention type(s): Drug; Other
Intervention description(s): 3 times a week perilesional or intramuscular injections; same as PDRN
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetes; foot ulcer; polydeoxyribonucleotide
Safety and Tolerability of Single and Multiple Doses of ISIS 353512 in Healthy Volunteers
Condition: Inflammatory Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of single and multiple
      doses of ISIS 353512, to evaluate the blood concentration and rate elimination of ISIS 353512
      from the blood, and to evaluate the effectiveness of ISIS 353512 in lowering a protein in the
      blood associated with inflammation.
    

Detailed description: 
      This will be a Phase 1, double blind, placebo-controlled, dose-escalation study conducted at
      a single center to 1)evaluate the safety and tolerability of single and multiple doses of
      ISIS 353512 administered intravenously and subcutaneously, 2)evaluate the pharmacokinetic
      profile of single and multiple doses of ISIS 353512 administered intravenously and
      subcutaneously, and 3)evaluate the pharmacodynamics of ISIS 353512 in lowering constitutive
      levels of c-reactive proteins in healthy volunteers.
    

Intervention name(s): ISIS 353512; ISIS 353512; ISIS 353512; ISIS 353512; ISIS 353512; ISIS 353512; ISIS 353512; ISIS 353512; ISIS 353512; ISIS 353512; ISIS 353512; ISIS 353512; ISIS 353512; ISIS 353512; ISIS 353512; ISIS 353512
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 50 mg via 2 hour IV infusion, single dose; 50 mg via 2 hour IV infusion, 6 doses over 22 days; 50 mg via SC injection, single dose; 50 mg via SC injection, 6 doses over 22 days; 2 hour IV infusion, 50 mg on day 3, 100 mg on day 5, and 200 mg on day 8; 100 mg via 2 hour IV infusion, single dose; 200 mg via 2 hour IV infusion, single dose; 100 mg via SC injection, single dose; 200 mg via SC injection, single-dose; 100 mg via 2 hour IV infusion, 6 doses over 22 days; 200 mg via 2 hour IV infusion, 6 doses over 22 days; 100 mg via SC injection, 6 doses over 22 days; 200 mg via SC injection, 6 doses over 22 days; 100 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or oral placebo; 200 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or steroid; 2 hour IV infusion, 50 mg on day 1, 100 mg on day 3, 100 mg on day 5 and 200mg on day 8
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Lamotrigine in the Treatment of Bipolar Disorder in Women of Reproductive Age
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Observational

Summary: 
      This project will expand current knowledge of reproductive biology in women with bipolar
      disorder as well as assessing the impact of lamotrigine use for the treatment of bipolar
      disorder on reproductive function. Specifically, this study examines mood over the menstrual
      cycle and ovulation for three consecutive menstrual cycles in women treated for bipolar I,
      II, or NOS (not otherwise specified) with lamotrigine. In addition, testosterone and lipid
      concentrations will be measured before the participant starts receiving lamotrigine, as well
      as six months after receiving lamotrigine.
    


Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Females age 18 through 45 with a diagnosis of bipolar, considering treatment with
        Lamotragine.
A Phase 1 Study of AIR645 in Healthy Subjects and Subjects With Controlled Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase one study to evaluate the safety, tolerability, and bioavailability of
      nebulized AIR645.
    


Intervention name(s): AIR645; Physiologic saline solution
Intervention type(s): Drug; Drug
Intervention description(s): AIR645 (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.; Placebo (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: AIR645; Altair Therapeutics; IL4; IL13; IL-4; IL-13
Increased Risk of ADHD Among Children With Bilateral Congenital Cataracts
Condition: Childhood Cataract
MeSH terms: Cataract; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      In this study, the investigators conducted a cross-sectional, face-to-face investigation to
      evaluate the behavioral and psychological disorders and the risk of ADHD among children with
      bilateral congenital cataracts using the Conners'Parent Rating Scale (CPRS) questionnaire, an
      assessment tool for screening ADHD that obtains parental reports of childhood behavioral
      problems in research and clinical settings.15-17 Age-matched children with normal vision and
      the Chinese urban norm were used as controls.
    


Intervention name(s): Psychological and Behavioral Problems
Intervention type(s): Other
Intervention description(s): Differences in age and sex between the CC and NV groups were compared using the independent samples t test and Chi-square test, respectively. Comparisons of abnormal rates between the CC and NV groups were performed using the Chi-square test. Scores on all subscales recorded for the CC group were compared with those of the NV group and the Chinese urban norm using the independent samples t test and one-sample t test, respectively.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        hospital-based
      
Keywords: congenital cataract; attention deficit hyperactivity disorder; Conners'Parent Rating Scale-48
Development of Dietary Supplements for Mood Symptoms in Postpartum
Condition: Postpartum Blues; Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether a dietary supplement (DS) is effective in
      protecting against sad mood in postpartum.
    

Detailed description: 
      The specific aim of this open-label study is to assess whether the proposed dietary
      supplement can reduce the intensity of sadness in women vulnerable to sadness (day-5
      postpartum women and women within the first 18 months postpartum with crying spells).
    

Intervention name(s): Motherwell
Intervention type(s): Drug
Intervention description(s): The interventions involves a dietary supplement called Motherwell, at current stage, to reduce the intensity of sadness in women vulnerable to sadness.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Postpartum; Dietary Supplements; Mood Symptoms
Efficacy and Safety of GSP 301 Nasal Spray in Children (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)
Condition: Seasonal Allergic Rhinitis (SAR)
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      Study to evaluate the efficacy, safety and tolerability of GSP 301 nasal spray (NS) compared
      with placebo NS in pediatric subjects (aged 6 to under 12 years) with Seasonal Allergic
      Rhinitis (SAR).
    


Intervention name(s): GSP 301 NS; GSP 301 Placebo NS
Intervention type(s): Drug; Drug
Intervention description(s): 1 spray in each nostril twice daily for 14 days; 1 spray in each nostril twice daily for 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: GSP 301 nasal spray for the treatment of Seasonal Allergic Rhinitis
A Crossover Study to Assess the Bioequivalence of Hydrocodone Bitartrate Extended-Release Tablet
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the bioequivalence of two 30-mg hydrocodone
      bitartrate extended-release tablets and one 60-mg hydrocodone bitartrate extended-release
      tablet.
    


Intervention name(s): a 60 mg dose of the hydrocodone bitartrate extended-release tablet administered as either two 30-mg tablets (Treatment A) or one 60-mg tablet (Treatment B).
Intervention type(s): Drug
Intervention description(s): Each subject will receive 1 treatment during each administration period. Subjects will receive each of the 2 treatments once. There will be a minimum 14-day washout period between the 2 administrations of study drug. Treatments will be orally administered to subjects, while they are seated, at approximately 0800 (±2 hours) on the 1st day of each administration period.
Intervention MeSH terms: Hydrocodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bioequivalence, hydrocodone bitartrate extended-release tablets
Subcutaneous Fat Reduction in the Submental Area
Condition: Body Fat Disorder
MeSH terms: Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      Study to Evaluate Non-Invasive Subcutaneous Fat Reduction in the Submental Area using
      Cryolipolysis.

      Healthy adult men and women with submental skin fold thickness > 1cm who desire reduction of
      submental fat.
    

Detailed description: 
      Non-invasive treatment for subcutaneous fat reduction in the submental area.
    

Intervention name(s): CoolSculpting System
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Transparent Cap-assisted Endoscopic Sclerotherapy
Condition: Esophageal Varices
MeSH terms: Esophageal and Gastric Varices
Study type: Interventional

Summary: 
      The aim of this study is to evaluate efficacy and safety of transparent cap-assisted
      endoscopic sclerotherapyI(lauromacrogol injection) in management of esophageal varices.
    

Detailed description: 
      Endoscopic procedures now play a great role in management of esophagogastric varices.
      Endoscopic variceal ligation(EVL) was recommended as first line therapy for primary and
      secondary prophylaxis in patients with esophageal varices. Previous studies have showed a
      superiority of EVL over endoscopic injection of sclerotherapy(EIS), mainly because of lower
      occurrence rate of complications. Procedure related complications were related to total
      amount of lauromacrogol, number of treatment and expertise of the endoscopists. Transparent
      cap has already been reported to assist in other endoscopic procedures, such as biopsy of
      Barret esophagus or endoscopic submucosal dissection. Accuracy and vision were improved with
      the help of transparent cap in the front of endoscopy. We have tried transparent cap-assisted
      sclerotherapy in some patients with in our hospital. Now a randomized controlled trial was
      conducted to evaluate efficacy and safety of transparent cap-assisted endoscopic
      sclerotherapy in management of esophageal varices.
    

Intervention name(s): assistance of a transparent cap; without a transparent cap
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients will receive endoscopic injection of lauromacrogol with assistance of a transparent cap.; Patients will receive routine endoscopic injection of lauromacrogol without use of transparent cap.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: endoscopic sclerotherapy, esophageal varices, transparent cap
(+) Epicatechin to Treat Friedreich's Ataxia
Condition: Friedreich's Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Study type: Interventional
Phase: Phase 2

Summary: 
      This 24-week study will test the safety and effectiveness of synthetically produced (+)
      Epicatechin in treating patients who have Friedreich's Ataxia, a neurological disorder.
    


Intervention name(s): (+)-Epicatechin
Intervention type(s): Drug
Intervention description(s): 25mg (+)-Epicatechin capsules. Starting dose 75mg total daily dose (one 25mg cap taken three times per day). Dose escalation at 12 weeks for non-responders to 150mg total daily dose (two 25mg caps taken three times per day)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment