bioihbjkbjnl/mcl2 huggingface dataset:
Risk of Fatigue in Adolescent and Young Adult Hodgkin Lymphoma Patients
Condition: Fatigue; Hodgkin Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease; Fatigue
Study type: Observational

Summary: 
      Fatigue is one of the most prevalent symptoms endorsed by cancer survivors, particularly
      those treated for breast cancer or Hodgkin lymphoma. Despite the tremendous implications such
      work has for effective interventions, little is known about the underlying pathophysiology of
      fatigue, association with medical co-morbidities and factors that may help predict those to
      be at highest risk.

      The proposed research will utilize Vanderbilt-Ingram Cancer Center REACH for Survivorship
      Program together with the investigators Hematologic Malignancies Program. In adolescent and
      young adults (AYA), ages 18 - 39 the investigators will address the following:

      Primary Aims Aim 1: Assess the prevalence and severity of fatigue and its impact on
      functional outcomes Aim 2: Determine host, disease and treatment-related risk factors for
      fatigue

      Secondary Aims Aim 1: Evaluate the association between levels of proinflammatory cytokine
      activity and fatigue Aim 2: Evaluate the association between fatigue and self reported
      fatigue in AYA Hodgkin lymphoma (HL) survivors.

      Hypotheses:

        1. Fatigue is more prevalent and severe among AYA HL patients and survivors, compared to
           general population and will be associated with impaired functional outcome.

        2. Risk factors for fatigue include higher disease stage, B symptoms and elevated
           erythrocyte sedimentation rate at diagnosis, dose density of chemotherapy and higher
           doses and more expanded fields of radiotherapy.

        3. Risk of fatigue is associated with long-term cardiopulmonary and endocrine
           complications.

        4. Levels of specified proinflammatory cytokines are associated with increased fatigue.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adolescents and young adult survivors of Hodgkin Lymphoma
      
Biospecimen description: 
      Serum samples for IL-1ra and CRP
    
Keywords: Hodgkin Lymphoma Survivors; Adolescent and Young Adults
Assessment of Coronary Plaque Composition Using Optical Coherence Tomography
Condition: Coronary Atherosclerosis; Endothelial Dysfunction; Coronary Small Vessel Disease
MeSH terms: Atherosclerosis; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigator's hypothesis is that local activation of the endogenous Lp-PLA2 plays an
      integral role in early atherosclerosis, and contributes to the mechanism of coronary
      endothelial dysfunction and to the structural and mechanical properties that characterize
      plaque vulnerability. Thus, the investigators study will characterize prospectively the
      correlation between the functional and structural vascular wall properties, and the activity
      of the Lp-PLA2 pathway.
    

Detailed description: 
      The present study was a substudy of our National Institute of Health (NIH) funded and
      Institutional Review Board (IRB) approved (08-008161) protocol "Lp-PLA2 and Coronary
      Atherosclerosis in Humans" and (10-000044) "Lp-PLA2 and Coronary Atherosclerosis in Humans
      Aim III" in which the investigators are examining the impact of long-term inhibition of
      Lp-PLA2, with a specific novel inhibitor, on Lp-PLA2 activity and improvement in coronary
      endothelial function.

      This substudy will use Optical Coherence Tomography (OCT) to quantify alternate features of
      plaque vulnerability including superficial microcalcification, fibrous cap thickness, and
      plaque macrophage content at baseline and again at 6 months following Lp-PLA2 inhibition.

      The study will provide insight into the role of the endogenous Lp-PLA2 in early coronary
      atherosclerosis, a potential therapeutic target for early coronary atherosclerosis in humans.
    

Intervention name(s): Optical Coherence Tomography (C7 XR Dragonfly )
Intervention type(s): Device
Intervention description(s): Evaluation of the coronary artery using Optical Coherence Tomography utilizing the Dragonfly OCT catheter following a clinically indicated angiogram and endothelial function testing with a positive diagnosis of endothelial dysfunction. The procedure is repeated following 6 months of Lp-PLa2 inhibition or placebo.
Other intervention name(s): C7 XR Dragonfly Optical Coherence Tomography system
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing
Condition: Hiatal Hernia
MeSH terms: Hernia; Hernia, Hiatal
Study type: Interventional

Summary: 
      One-hundred and fifty-nine patients undergoing Nissen fundoplication for symptomatic
      gastro-oesophageal reflux disease (GORD), who had a concomitant hiatal hernia of > 2 cm axial
      length, were randomized to closure of the diaphragmatic hiatus with either crural sutures
      alone or tension-free closure with a non-absorbable mesh. Primary outcome variable was the
      incidence of radiologically verified recurrent hiatal hernia. Secondary outcomes were per-and
      postoperative complications and courses, symptomatic recurrence rate, use of PPI,
      postoperative oesophageal acid exposure and Quality of Life.
    

Detailed description: 
      The basic principles behind successful surgical repair of the anatomy and function of the
      gastro-oesophageal junction (GOJ) in gastro-oesophageal reflux disease (GORD) is not only to
      encircle the distal oesophagus and GOJ by the fundic wrap but also to complete a transhiatal
      reduction of a concomitant hiatal hernia (type I, HH), aiming for a 2 - 3 cm intra-abdominal
      length of the of oesophagus and to transact a tension-free hiatal closure. The physiological
      and morphological characteristics of the diaphragmatic hiatus, however, carry a challenge for
      the selection of the ideal technique for surgical repair. The diaphragmatic hiatus consists
      of a three-dimensional structure in constant motion, which creates a border between the
      counteracting pressures prevailing in the abdominal and chest cavities, respectively.
      Following hernia reduction, the structural quality of the diaphragmatic pillars is usually
      weak, offering poor support for the subsequent closure with risk for high recurrence rates.
      These and other considerations have encouraged the exploration of mesh reinforcement to
      enhance the durability of the hiatal closure.
    

Intervention name(s): Hiatal hernia repair by tension-free mesh closure; Hiatal hernia repair by simple suturing
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: repair by tension-free mesh closure or simple suturing of the diaphragmatic
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate the Safety, Tolerability, and Blood Pressure Effect of an Oral Dose of Sumatriptan Alone and in Combination With MK-0974 (Telcagepant) in Migraine Patients (0974-026)
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to understand the effects of migraine treatments on blood pressure in participants with
      migraine. The primary hypothesis is that the effect on semi-recumbent mean arterial pressure
      following the coadministration of telcagepant and sumatriptan is similar to that following
      administration of sumatriptan alone. That is, the true mean treatment difference (sumatriptan
      with telcagepant sumatriptan alone) in time-weighted mean arterial pressure for 2.5 hours
      following dosing is less than 5 mmHg.
    


Intervention name(s): telcagepant potassium; sumatriptan; sumatriptan placebo; telcagepant potassium placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single oral dose of 2 x 300 mg capsules.; single oral dose of 100 mg sumatriptan; single oral dose; single oral dose of 2 MK-0974 placebo capsules
Intervention MeSH terms: Sumatriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Statin Therapy on Disease Progression in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Condition: Polycystic Kidney, Autosomal Dominant
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant; Disease Progression
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether the medication pravastatin will ameliorate
      renal and cardiovascular disease over a 3-year period in children and young adults with
      autosomal dominant polycystic kidney disease (ADPKD).
    

Detailed description: 
      Autosomal dominant polycystic kidney disease (ADPKD) is the most common hereditary kidney
      disease, affecting 1 in 400 to 1000 individuals and accounting for 4% of end-stage renal
      disease in the United States and 8-10% in Europe. The condition is characterized by
      progressive development of kidney cysts with kidney enlargement and associated loss of kidney
      function. High blood pressure and cardiovascular disease are common in patients with ADPKD.
      Although the condition is often thought to affect primarily adults, it is clear that the
      disease can be present in the fetus and young children.

      This study was designed to determine if treatment with the medicine pravastatin can slow the
      progression of kidney and heart disease when initiated early in life in patients with ADPKD.
      The Investigators will assess differences between pravastatin and placebo study groups over
      the three-year study period with respect to: 1) total kidney volume as assessed by magnetic
      resonance imaging (MRI); 2) left ventricular mass index as assessed by MRI; 3) urinary
      albumin excretion; and 4) endothelial-dependent vasodilation as assessed by brachial
      ultrasound. A total of 110 subjects were enrolled in this research study. This study involved
      pediatric subjects because the Investigators believe that early intervention is critical if
      they are to decrease the morbidity and mortality associated with this condition. If
      pravastatin is shown to be effective in ameliorating progression of renal and cardiovascular
      disease in this study, routine management of people with this condition will be drastically
      altered.
    

Intervention name(s): pravastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pravastatin 20 mg daily (subject age 8-12 years) or 40 mg daily (subject age 13-21 years); Placebo daily
Intervention MeSH terms: Pravastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autosomal dominant polycystic kidney disease; Cystic kidney disease; High blood pressure; Statin
Endometrial Scratch Injury in Women With Unexplained Infertility Undergoing IUI
Condition: Unexplained Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The study included 154 infertile women Patients received 100 mg of oral clomiphene citrate
      for five days starting on day 3 of the menstrual cycle, followed by daily injection of 150 IU
      of hMG and when more than two dominant follicles reached a diameter of 17 mm 5,000 IU of hCG
      was injected intramuscularly. Patients were randomly allocated into two equal groups: Group C
      received IUI without ESI and Group S had ESI using No.8 neonatal feeding tube and after 24 to
      36 hours, IUI was performed. Successful pregnancy was con-firmed by ultrasound and patients
      had failed trial underwent another trial of IUI for a maximum of three trials.
    

Detailed description: 
      The study included 154 infertile women with mean duration of infertility of 3.9±0.4 years.
      Patients received 100 mg of oral clomiphene citrate for five days starting on day 3 of the
      menstrual cycle, followed by daily injection of 150 IU of hMG and when more than two dominant
      follicles reached a diameter of 17 mm 5,000 IU of hCG was injected intramuscularly. Patients
      were randomly allocated into two equal groups: Group C received IUI without ESI and Group S
      had ESI using No.8 neonatal feeding tube and after 24 to 36 hours, IUI was performed.
      Successful pregnancy was con-firmed by ultrasound and patients had failed trial underwent
      another trial of IUI for a maximum of three trials.
    

Intervention name(s): endometrial scratch injury
Intervention type(s): Procedure
Intervention description(s): ESI using No.8 neonatal feeding tube
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Endometrial Scratch Injury; Unexplained infertility; intrauterine insemenation; ovulation induction
The Effects of Hydromorphone on Responses to Verbal Tasks
Condition: Healthy
Study type: Interventional

Summary: 
      In this study, the investigators will examine the effects of hydromorphone, as compared to
      placebo, upon physiological, subjective, and hormonal responses to a stressful speech task
      and a non-stressful control task in healthy adults. There is strong evidence in support of
      the role of endogenous opioids and opiates in mediating social behavior in humans and other
      animals, and particularly, in social distress. The investigators have recently shown that
      buprenorphine, a partial mu-opioid agonist, reduces cortisol responses to stress. Here, the
      investigators propose to further explore the role of the opioid system in mediating stress
      responses in humans through the use of hydromorphone, a full mu opioid agonist, in addition
      to acetaminophen. The investigators hypothesize that like acetaminophen, hydromorphone will
      reduce both physiological and subjective measures of stress.
    

Detailed description: 
      Participants be randomly assigned to receive 1000 mg acetaminophen, 2mg hydromorphone, 4mg
      hydromorphone, or placebo at each of two sessions; one during which they well participate in
      a stressful speaking task, and one during which they'll participate in a nonstressful control
      task. Physiological and subjective measures will be taken throughout each session.
    

Intervention name(s): 2 mg hydromorphone; 1000 mg Acetaminophen; 4 mg hydromorphone; dextrose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task.; We are administering sublingual buprenorphine to healthy volunteers to measure its effects on the performance of a verbal task.; We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task.; We are administering dextrose to healthy volunteers for our placebo group.
Intervention MeSH terms: Acetaminophen; Hydromorphone
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: enrolling; adult; volunteers
Effects of Fatigue and Foot Orthoses on Lower Extremity EMG and Biomechanics for Individuals With Flat Foot
Condition: Flexible Flatfoot
MeSH terms: Flatfoot
Study type: Observational

Summary: 
      Determine the effects of non-custom made foot orthoses on the kinematics, muscle activity and
      joint contact force after fatigue and compare the rate of fatigue in flexible flat foot with
      and without foot orthoses
    


Intervention name(s): Non-custom made foot orthoses
Intervention type(s): Device
Intervention description(s): Foot orthoses is an orthotic devices which are used to support arch and rear-foot and put it in a good alignment.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Flexible flatfoot
Blood and Saliva Sample Collection for AREDS 2
Condition: Age-Related Macular Degeneration; Eye Diseases
MeSH terms: Macular Degeneration; Eye Diseases
Study type: Observational

Summary: 
      Background:

      - The Age-Related Eye Disease Study 2 (AREDS 2) is looking at different eye diseases. Study
      participants will provide blood and saliva samples. The samples will be stored for research
      on eye diseases.

      Objectives:

      - To collect blood and saliva samples for AREDS 2 research.

      Eligibility:

      - AREDS 2 research study participants.

      Design:

        -  Participants will provide blood and saliva samples.

        -  The samples will be submitted with personal and medical information. This information
           will be collected during the AREDS 2 procedures.
    

Detailed description: 
      AREDS2 is a multi-center, Phase III, randomized clinical trial designed to assess the effects
      of oral supplementation of high doses of macular xanthophylls (lutein and zeaxanthin) and/or
      omega-3 long-chain polyunsaturated fatty acids (LCPUFAs) as a treatment for age-related
      macular degeneration (AMD), cataract and moderate vision loss. In addition to this objective,
      the AREDS2 study will provide information on the clinical course, prognosis, and risk factors
      for development and progression of both AMD and cataract. Other study goals include the
      evaluation of eliminating beta-carotene and/or reducing zinc in the original AREDS
      formulation on the progression and development of AMD. AREDS2 will also seek to validate the
      fundus photographic AMD scale developed from AREDS.

      The objective of this protocol is to have AREDS2 participants submit blood and saliva samples
      to the AREDS2 Genetic Repository (Fisher BioServices, Rockville, MD) in order to provide
      further materials for the study of the genetic and biochemical bases for eye disease and
      possibly other diseases.
    

Time perspective: Prospective
Keywords: Age-Related Macular Degeneration (AMD); Eye Diseases
PAS for Lower Extremity Rehabilitation in Tetraplegic Patients
Condition: Spinal Cord Injuries; Spinal Cord Diseases
MeSH terms: Spinal Cord Injuries; Spinal Cord Diseases
Study type: Interventional

Summary: 
      The investigators have recently shown in incomplete SCI patients that long-term paired
      associative stimulation is capable of restoring voluntary control over some paralyzed muscles
      and enhancing motor output in the weak muscles (1,2). In this study, the investigators will
      administer long-term paired associative stimulation to patients with incomplete cervical
      level SCI and investigate its effectiveness for lower extremity rehabilitation.
    


Intervention name(s): Paired associative stimulation (with eXimia magnetic stimulator and Dantec Keypoint® electroneuromyography device)
Intervention type(s): Device
Intervention description(s): Paired associative stimulation (PAS) administered several times per week for 8 weeks to lower limbs. PAS comprises transcranial magnetic stimulation (eXimia magnetic stimulator, Nexstim Ltd, Helsinki, Finland) and peripheral nerve stimulation (given with Dantec Keypoint® electroneuromyography device (Natus Medical Incorporated, Pleasanton, CA, USA)).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Myofascial Release on Muscle Mechanical Properties
Condition: Sports Physical Therapy
Study type: Interventional

Summary: 
      This study evaluates effect of self-myofascial release in different paces on muscle
      biomechanics. All participants will use foam roller in different paces once in a week with
      weeks apart.
    

Detailed description: 
      Foam-roller is a widely used self-myofascial release method in sports. Although, effects of
      foam-roller has been shown, there is no defined speed of usage. Using foam-roller in
      different paces could cause different changes.
    

Intervention name(s): 30 rolls per minute(30RPM); 15 rolls per minute(15RPM); self-determined
Intervention type(s): Other; Other; Other
Intervention description(s): Participants will start using foam roller from muscle origin to insertion with a speed of 2 secs. Then comeback from insertion to origin with 2 secs. With total of 15 repeats x 2 sets per leg. With 30 seconds rest between.; Participants will start using foam roller from muscle origin to insertion with a speed of 4 secs. Then comeback from insertion to origin with 4 secs. With total of 15 repeats x 2 sets per leg. With 30 seconds rest between.; Participants will start using foam roller from muscle origin to insertion with self determined-speed. Then comeback from insertion to origin with same pace. With total of 15 repeats x 2 sets per leg. With 30 seconds rest between.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will use a foam roller at three different paces in a randomized sequence with a week between,
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sports physiotherapy; self-myofascial release; foam-roller; muscle biomechanical properties