bioihbjkbjnl/mcl2 huggingface dataset:
Individualized Discharge Planning in Patients With Rib Fracture
Condition: Rib Fractures
MeSH terms: Fractures, Bone; Rib Fractures
Study type: Interventional

Summary: 
      Patients with rib fractures may develop pneumonia and even respiratory failure requiring
      critical care, ventilator management, and hospitalization. Discharge planning is a broad
      range of time-limited services designed to ensure healthcare continuity, avoid preventable
      poor outcomes among at-risk populations, and promote the safe and timely transfer of patients
      care.
    


Intervention name(s): Individualized discharge planning
Intervention type(s): Behavioral
Intervention description(s): Discharge planning is designed to ensure healthcare continuity, avoid preventable poor outcomes among at-risk populations, and promote the safe and timely transfer of patient care. The individualized discharge planning is characterized to take into account the preferences, interests and clinical profile of each patient.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Evaluating the Safety and Tolerability of the Poly-ADP Ribose (PARP) Inhibitor With FOLFIRI in Subjects With Solid Tumor
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Assess whether the combination of ABT-888 with FOLFIRI has activity in subjects with gastric
      cancer.
    


Intervention name(s): Veliparib
Intervention type(s): Drug
Intervention description(s): Subjects will be given Veliparib twice daily on Days 1-5 and 15-19 every 28 days orally
Other intervention name(s): ABT-888, Veliparib
Intervention MeSH terms: Veliparib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastric Cancer
One Month Dispensing Study Comparing the Clinical Performance of the Comfilcon A Sphere Lenses Compared to Comfilcon A Asphere Lenses.
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      This is a prospective, multi-center, subject-masked, bilateral wear, one month dispensing
      study comparing the clinical performance of the subjects' habitual comfilcon A sphere lens
      (control) following a refit with comfilcon A asphere lens (test). After the dispensing visit,
      subjects will return for follow-up evaluations after 2 weeks, and 1 month.
    

Detailed description: 
      This is a prospective, multi-center, subject-masked, bilateral wear, one month dispensing
      study comparing the clinical performance of the subjects' habitual comfilcon A sphere lens
      (control) following a refit with comfilcon A asphere lens (test). After the dispensing visit,
      subjects will return for follow-up evaluations after 2 weeks, and 1 month.

      Both comfilcon A sphere lens (control) and comfilcon A asphere lens (test) are Coopervison
      lenses.
    

Intervention name(s): comfilcon A sphere lens (control); comfilcon A asphere lens (test)
Intervention type(s): Device; Device
Intervention description(s): contact lens; contact lens
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Other
BFR and Muscle Mitochondrial Oxidative Capacity
Condition: Mitochondria; Strength; Hypertrophy
MeSH terms: Hypertrophy
Study type: Interventional

Summary: 
      Blood flow restricted (BFR) exercise has been shown to improve skeletal muscle adaptations to
      resistance exercise. BFR uses blood pressure cuffs (i.e., tourniquets) to reduce skeletal
      muscle blood flow during resistance exercise. One benefit of BFR is that skeletal muscle
      adaptations to resistance exercise training including muscle hypertrophy and increases in
      strength can be achieved at lower-loads (e.g., 25-30% 1RM), that are often comparable to more
      traditional resistance training loads (70-85% 1RM). However, the impact that low-load BFR
      resistance exercise has on muscle quality and bioenergetics is unknown. The present study
      will examine the impact of 6 weeks of low-load, single-leg resistance exercise training with
      or without personalized BFR on measures of muscle mass, strength, quality, and mitochondrial
      bioenergetics. The investigators will recruit and study up to 30, previously sedentary,
      healthy, college-aged adults (18-40 years). The investigators will measure muscle mass using
      Dual Energy X-Ray Absorptiometry and muscle strength and endurance using isokinetic testing.
      The investigators will normalize knee extensor strength to lower limb lean mass to quantify
      muscle quality. The investigators will also use near infrared spectroscopy (NIRS) to measure
      mitochondrial oxidative capacity in the vastus lateralis. Finally, the investigators will
      measure markers of systemic inflammation and markers of muscle damage using commercially
      available ELISA assays.
    


Intervention name(s): Low Load Resistance Exercise; Low Load Resistance Exercise + BFR
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects allocated to Low Load Resistance Exercise will undergo 6 weeks of single-legged low load (25%) resistance exercise. Subjects will then perform 4 sets of 30, 15, 15 and 15 repetitions at 25% of their 1RM for the single-legged leg press and single-legged knee extensions. Their contralateral leg will serve as within subject control.; Subjects allocated to Low Load Resistance Exercise + BFR will undergo 6 weeks of single-legged low load (25%) resistance exercise with blood flow restriction (60% occlusion pressure). Subjects will then perform 4 sets of 30, 15, 15 and 15 repetitions at 25% of their 1RM for the single-legged leg press and single-legged knee extensions. Their contralateral leg will serve as within subject control.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Radiation Therapy With or Without Cisplatin in Treating Patients With Advanced Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in
      chemotherapy use different ways to stop tumor cells from dividing so they stop growing or
      die. It is not yet known if radiation therapy plus chemotherapy is more effective than
      radiation therapy alone in treating patients with advanced head and neck cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus
      cisplatin with radiation therapy alone in treating patients with advanced head and neck
      cancer.
    

Detailed description: 
      OBJECTIVES: I. Assess the time to treatment failure (local and regional) in patients with
      moderately advanced and advanced squamous cell carcinoma of the head and neck (no distant
      metastases) when treated with hyperfractionated radiotherapy with vs. without 2 courses of
      simultaneously administered cisplatin. II. Assess the time to distant metastatic relapse,
      overall survival, and toxicity in patients receiving these treatments. III. Evaluate whether
      the potential tumor-doubling time is an indicator for risk of treatment failure in patients
      receiving these treatments.

      OUTLINE: Randomized study. Arm I: Radiotherapy plus Single-Agent Chemotherapy followed, as
      indicated, by Surgery. Hyperfractionated external-beam tumor irradiation using photon
      energies of 4-6 MV or electrons of 6-12 MV (interstitial brachytherapy boost to lesions of
      the oral cavity allowed); plus Cisplatin, CDDP, NSC-119875; followed, in patients with
      persistent disease (at the discretion of the surgeon), by resection of primary tumor or
      involved nodes. Arm II: Hyperfractionated radiotherapy followed by Surgery. Tumor irradiation
      as in Arm I; followed by resection as in Arm I.

      PROJECTED ACCRUAL: At least 400 patients will be accrued over 5 years. Interim analyses to
      allow for early stopping will be carried out after entry of 50 and 100 patients.
    

Intervention name(s): chemotherapy; cisplatin; low-LET cobalt-60 gamma ray therapy; low-LET electron therapy; low-LET photon therapy
Intervention type(s): Drug; Drug; Radiation; Radiation; Radiation
Intervention MeSH terms: Cobalt
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage III squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx
Trampoline Exercises Children With Developmental Coordination Disorder
Condition: Developmental Coordination Disorder
MeSH terms: Motor Skills Disorders
Study type: Interventional

Summary: 
      RCT in which 28 children with developmental coordination disorder (DCD) were enrolled and
      equally distributed into two groups; Participants in control group were treated with
      conventional physical therapy while experimental were given conventional physical therapy in
      addition to trampoline exercises. Assessment was at 0, 4 and 8 week using developmental
      coordination disorder questionnaire (DCDQ), pediatric balance scale (PBS) and peads quality
      of life (PQL)
    


Intervention name(s): Jumping Exercises; Conventional Physical therapy
Intervention type(s): Other; Other
Intervention description(s): Jumping in place Jump and clap Jump and reach Jump and twist Jump and turn Half jumping jack Jumping side to side Each exercise done for 1 minute, 5 repetitions is session of 1 hour 15minutes; Drop and catch a ball Squeeze ball between legs, jump up and catch the ball Walking on a straight line Stand on one leg try to pick object from floor without using hands (do this on both legs) Drop the ball and catch it with both hands Jump up stair with both limbs off the floor simultaneously while holding railing.
Skipping. At least 5 repetitions for each exercise in session of total 1 hour
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Balance; Developmental coordination disorder; Motor Activity; Quality of Life
Effect of Anorectal Biofeedback on Encopresis in School Aged Girls After Sexual Assault
Condition: Fecal Incontinence
MeSH terms: Fecal Incontinence; Encopresis
Study type: Interventional

Summary: 
      Females who have been sexually abused anally, have a disturbed anorectal motility. They have
      an increased resting pressure at the lower part of the anal canal. When their rectum is
      suddenly distended, they tend not to have an initially increased pressure in the anal canal,
      and the recto-anal inhibitory reflex is markedly decreased amplitude which is caused by
      reflex contraction of the pelvic floor during the relaxation of the internal anal sphincter.
    

Detailed description: 
      The cause of fecal incontinence after sexual abuse is the improper functioning of anal
      sphincter muscles, as a result of their damage and/or neurological changes including the
      disturbance perception of sensory stimuli from the anal canal. Biofeedback therapy using
      visual and verbal feedback techniques has emerged as an useful option in managing fecal
      incontinence and levator ani syndrome. The goal of biofeedback training is to improve bowel
      function by restoring a normal pattern of defecation.
    

Intervention name(s): Anorectal manometry
Intervention type(s): Device
Intervention description(s): , patients are instructed to isolate the anal sphincter and puborectalis muscles and improve its strength by using modified Kegel exercises in lying position with a probe in situ. Visual and verbal feedback techniques are used to reinforce the maneuvers, as they are being performed. The anal and rectal pressure changes displayed on the monitor provides visual feedback to the patient.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Telehealth Enhanced Asthma Management
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This study will conduct a 12-month randomized trial with 48 pediatric patients (aged 6-18
      years) with persistent asthma to compare outcomes among patients with follow-up visits
      managed via telemedicine (TM) vs. in-person (IP) visits.
    

Detailed description: 
      The overarching hypothesis is that utilization of TM for asthma follow-up will result in
      improved clinical outcomes such as Asthma Control Test (ACT) scores, lung function and
      medication adherence compared to participants receiving IP follow-up care. The Investigator
      also hypothesize that TM follow-up will result in higher caregiver satisfaction because
      families will be able to receive quality subspecialty care in their community (TM) compared
      to those who travel a distance to receive care (IP).
    

Intervention name(s): Asthma Subspecialty Follow-up Visits
Intervention type(s): Other
Intervention description(s): Pediatric patients with persistent asthma will be recruited to compare outcomes among patients with follow-up visits managed via telemedicine vs. in-person visits.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: One group will receive asthma follow up care via telemedicine at a remote clinical sites. The second group will receive in-person asthma follow-up care at a specialty clinic.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Telemedicine; Clinical follow up visits
A Trial for New Treatment of Adult Participants With Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      A study to evaluate the effectiveness of oral doses of Blautix in adult participants with
      irritable bowel syndrome (IBS).
    

Detailed description: 
      Participants with a diagnosis of IBS will be enrolled as defined by Rome IV criteria and will
      be classified into cohorts according to the Rome IV classification of IBS subtypes.

      Each cohort (Cohort C and Cohort D) will recruit participants who will randomly receive
      either Blautix or matching placebo in a 1:1 ratio overall of treated to control participants.

      Participants will undergo five visits in total across approximately 13 weeks. During the
      study treatment phase, participants will be asked to complete a variety of Quality of Life
      questionnaires at certain time points. These will consist of abdominal pain intensity score,
      IBS symptom severity (IBS-SSS), IBS quality of life (IBS-QoL), hospital anxiety and
      depression score (HADS), stool frequency, stool consistency & food frequency questionnaire.

      Participants will be required to produce relevant blood, urine and faecal samples at
      pre-determined timepoints from screening through to End of Treatment and follow up visits.
    

Intervention name(s): Blautix; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Blautix is a live biotherapeutic product consisting of a lyophilised formulation of a proprietary strain of bacterium. The study dosing regimen was two capsules two times per day for the duration of the treatment period.; Placebo control
Other intervention name(s): MRx1234; Blautia Hydrogenotrophica
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: constipation; diarrhea
Efficacy, Safety, and Tolerability Study of Pirfenidone in Combination With Sildenafil in Participants With Advanced Idiopathic Pulmonary Fibrosis (IPF) and Intermediate or High Probability of Group 3 Pulmonary Hypertension
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Hypertension, Pulmonary; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Hypertension; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase IIb, randomized, placebo-controlled, multicenter, international study will
      evaluate the efficacy, safety, and tolerability of sildenafil or placebo added to pirfenidone
      (Esbriet) treatment in participants with advanced IPF and intermediate or high probability of
      Group 3 pulmonary hypertension (PH) who are on a stable dose of pirfenidone with demonstrated
      tolerability. Participants will be randomized to receive 1 year of treatment with either oral
      sildenafil or matching placebo while continuing to take pirfenidone.
    


Intervention name(s): Pirfenidone; Placebo; Sildenafil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pirfenidone will be given in the range of 1602 to 2403 milligram per day (mg/day), as 3 divided doses.; Placebo matched with sildenafil.; Sildenafil will be given as 20 mg, TID.
Other intervention name(s): Esbriet, RO0220912; RO0280296
Intervention MeSH terms: Pirfenidone; Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Vascular Endothelial Inflammation and Dysfunction in Pediatric Long-term Cancer Survivors
Condition: Cancer Survivor; Pediatric Cancer
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Survivors of childhood cancer have an increased risk of death from cardiovascular disease due
      to both the therapies they received while undergoing treatment and diet and lifestyle
      factors. The nature of cardiovascular risk and the interaction between treatment affects and
      cardiovascular risk factors is unknown. We propose to study vascular inflammatory markers as
      well as measure of blood vessel stiffness (both of which are predictive of early heart
      disease) in 100 pediatric cancer survivors and 100 control children. Characterization of
      vascular inflammation and stiffness in long-term survivors will allow for the development of
      future interventions to decrease inflammation through both pharmacologic and lifestyle
      modifications.
    


Intervention name(s): Blood specimen; Echocardiography
Intervention type(s): Procedure; Procedure
Other intervention name(s): Flow mediated vasodilation; Carotid intimal media thickness; Bone Mineral Density
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Cancer survivors; Long-term cancer survivor
Acoustic Tribology Validation Study
Condition: Mouth Feel in Relation to Food Preference and Energy Intake
Study type: Observational

Summary: 
      Dairy-based beverages contain fat and sugars. As both contribute to the energy intake upon
      consumption, food industry strives to reduce these ingredients while maintaining the taste,
      texture and aroma properties of the beverages. A successful reduction of fat and sugar from
      drinks has still proven a great challenge since consumers have less preference for the mouth
      feel of reformulated beverages than for the regular beverages. Mainly because instrumental
      measures like rheology and traditional tribology do not entirely predict the experienced
      mouth feel, there is an interest in alternative correlates for mouth feel aspects related to
      fat and sugar perception. In a recent study it was demonstrated that vibrations produced
      during interaction between the tongue, palate and beverages during consumption are very
      sensitive to the amount of fat and texturizers in the beverage. The present study aims at
      clarifying that relation for a larger panel of human subjects, by systematically evaluating
      vibration spectra during consumption of dairy beverages that differ in fat content, sugar
      content or pH. Secondly, the correlation of vibration spectra (acoustic tribology) with mouth
      feel-related sensory properties and composition of fat deposits on the tongue will be
      assessed.
    


Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        16 volunteers from the local general population
      
Biospecimen description: 
      tongue scrapings
    
Keywords: mouth feel; acoustic tribology; vibration spectrum; sensory perception
Neural Signatures of Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The purpose of this study is to provide objective measurements of abnormal movements of the
      body in correlation with neural activity of the brain and track how these change over time.
      This may allow for the development of objective evaluation of the neural activity causing
      abnormal movements, which may lead to the ability of the DBS system to stimulate the brain by
      sensing the abnormal neural activity that is causing abnormal movements.
    


Intervention name(s): Activa PC+S
Intervention type(s): Device
Intervention description(s): The Model 37604 Activa PC+S is a multiprogrammable device that can deliver therapeutic electrical stimulation and record bioelectric signals from leads implanted in the brain.
Other intervention name(s): Model 37604
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Parkinson's Disease; DBS; Deep Brain Stimulation; Subthalamic Nucleus
Effect of Different Biomimetic Materials on White Spot Lesions in Enamel
Condition: White Spot Lesion
Study type: Interventional

Summary: 
      This study will be conducted to evaluate: 1- The remineralizing effect of different
      biomimetic materials (Zinc carbonate hydroxyapatite nanoparticles, Poly-amido amine (PAMAM)
      and bioactive glass nanoparticles) on white spot lesions in enamel. 2- The clinical efficacy
      of these agents on disappearance of these white spots.
    


Intervention name(s): Time of assessment
Intervention type(s): Other
Intervention description(s): Immediate and after one month and after two months
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Split mouth technique
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-933043 in Healthy Subjects
Condition: Healthy Adult Normals
Study type: Interventional
Phase: Phase 1

Summary: 
      Includes a placebo-controlled sequential, ascending multiple-dose panels (10 panels, 8
      ascending doses, and 2 fixed Japanese Panels exploring safety, tolerability, and
      Pharmacokinetic (PK) measures
    


Intervention name(s): BMS-933043; Placebo matching with BMS-933043; Antacid Buffer Predose Solution
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Antacids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science