bioihbjkbjnl/mcl2 huggingface dataset:
INDEPENDENCE Spacer for Lumbar Fusion
Condition: Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration
Study type: Observational

Summary: 
      The primary objective of this study is to evaluate radiographic outcomes, intra-operative
      parameters, clinical outcomes, and patient satisfaction following circumferential fusion
      using the INDEPENDENCE® integrated plate and spacer with REVOLVE® Stabilization System for
      the treatment of severe low back pain due to lumbar disc degeneration unresponsive to 6
      months of non-operative treatment.
    

Detailed description: 
      A total of thirty subjects will be enrolled at Scott & White Healthcare. The INDEPENDENCE
      spacer will be filled with autogenous bone graft material. The devices subject to this
      Agreement have received 510(k) clearance from the FDA for the indications specified in this
      Agreement.

      Patients will be followed for 2 years with evaluations at the following time intervals:
      preoperatively (within 2 months of surgery) and postoperatively at 6 weeks, 3 months, 6
      months, 12 months, and 24 months.
    

Intervention name(s): INDEPENDENCE
Intervention type(s): Device
Intervention description(s): Lumbar Integrated plate and spacer, with percutaneous screws and rods.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients between ages 18 and 65 withsevere low back pain due to lumbar disc degeneration
        unresponsive to 6 months of non-operative treatm
The EvAluation of TaBlo In-CLinic and In-HOme
Condition: End Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the Tablo Hemodialysis System when used In-Center by
      trained individuals and In-Home by trained Subjects.
    


Intervention name(s): Tablo Hemodialysis System
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Subjects will be enrolled in the trial for approximately 21 weeks according to the following schedule:
Run-in, In-Center - Subjects undergo study staff administered dialysis treatment 4 times/week for 1 week
Treatment Period 1, In-Center - Subjects undergo study staff administered dialysis treatment 4 times/week for 32 treatments (approximately 8 weeks)
In-Home Transition - Subjects undergo device training for the study, perform self-care dialysis 4 times/week for approximately 4 weeks, and are assessed for stability in the new care environment.
Treatment Period 2, In-Home - Subjects undergo self-care dialysis treatment 4 times/week for 32 treatments (approximately 8 weeks)
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Rifampin on Bosutinib When Both Are Given to Healthy People
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to examine whether rifampin has an effect on the pharmacokinetics of bosutinib.
    


Intervention name(s): Bosutinib
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: healthy subjects
Get-a-Grip Lifestyle Management Programme
Condition: Overweight and Obesity; Hypertension; Dyslipidemias; Diabetes
MeSH terms: Obesity; Overweight; Dyslipidemias
Study type: Interventional

Summary: 
      The primary aim of this study was to examine weight reduction in primary care in obese or
      overweight subjects with a comorbidity that would benefit from weight loss during 1-year
      comprehensive lifestyle management programme including medical examinations, personalized
      dietary and exercise advice, guidance on shopping behaviour and food preparation, and group
      discussions.
    

Detailed description: 
      Obesity is associated with altered glucose and lipid metabolism, and elevated blood pressure
      (BP) increasing the risk of cardiovascular morbidity and mortality. Obesity-induced
      complications are increasingly encountered in the health care system and especially in
      primary care. Thus, there is a growing need for individually tailored weight management
      programs aiming to permanent lifestyle and dietary changes for the prevention and treatment
      of obesity-related health hazards.

      The study investigated weight reduction during 1-year comprehensive lifestyle programme in
      134 obese or overweight subjects (BMI>30, or BMI>25 with a comorbidity including diabetes,
      hypertension, arthrosis, asthma, chronic obstructive lung disease, sleep apnoea). The
      participants were recruited from the local diabetes centre and health care providers. The
      programme aimed at 5-10 % weight reduction utilizing exercise program supervised by personal
      trainer, advice on diet and on-location shopping behavior by a registered dietician, hands-on
      cooking classes by a professional chef, examinations by a medical doctor, and group
      discussions. The efficacy of the program was followed by measuring change in weight, BMI,
      waist circumference, fat and muscle percentage, visceral fat, and systolic and diastolic BP.

      The study protocol has been approved by the ethics committee of the Pirkanmaa Hospital
      District (R12099).
    

Intervention name(s): Lifestyle management programme
Intervention type(s): Behavioral
Intervention description(s): The programme consisted of 1) the initiation phase (1-3 months), 2) the establishment phase (3-6 months), and 3) the maintenance phase (7-12 months). Guidance was given altogether on 25 separate occasions with special emphasis on the motivation and education. The goal for weight loss was 5-10 %. The programme included four visits by medical doctor, an educational lecture by medical doctor and personal trainer, five sessions by registered dietician, two cooking classes by professional chef, two group discussions, and exercise as follows: personalized exercise program tailored by personal trainer, one-year gym access with four guided group sessions, and two guided group Nordic walking sessions, and three individual exercise sessions by personal trainer.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diet; Exercise; Lifestyle; Weight control
The Influence of Red Grape Cells on Blood Pressure Vascular Function in People With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The study hypothesis is that 3 Months Daily Supplementation of RGC will effect blood pressure
      and vascular function.

      This will be a single-center, double-blind, random, parallel controlled Study. Study
      population will include 60 subjects, who will be divided randomly into three groups. The
      first group will get RGC 200mg, the second group will get RGC 400mg, and the third group will
      get 200mg placebo.
    


Intervention name(s): RGC; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): dosage of Red Grape Cells once a day, during 3 months; dosage of Placebo once a day, during 3 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effects of Dairy Products on Energy Balance
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The aim of the study is to investigate the long time effects of high and low intake of dairy
      products on fecal fat excretion, weight loss, blood pressure, lipid profile, lipid oxidation
      and appetite regulation in moderately overweight men and women over 24 weeks.
    


Intervention name(s): High Calcium intake from dairy products
Intervention type(s): Other
Intervention description(s): High dietary intake of calcium from dairy products (~1200 mg/d)
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: obesity; metabolic syndrome; fecal fat excretion; fecal calcium; weight loss; appetite regulation; intestinal micro flora; lipid profile; energy balance
Challenge Dose of Hepatitis B Vaccine in Subjects Who Previously Received Engerix™-B Vaccine
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the response to an additional dose (challenge dose) of hepatitis B vaccine, when
      given to subjects who had received primary vaccination of Engerix™-B vaccine approximately
      72-78 months ago.

      This protocol posting deals with objectives & outcome measures of the challenge phase. The
      Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
    


Intervention name(s): Engerix™-B
Intervention type(s): Biological
Intervention description(s): One dose (10µg Hepatitis B surface antigen (HBsAg))
Other intervention name(s): Hepatitis B vaccine
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis B; Persistence; Challenge dose
Effect of Oatmeal Varieties on Glycemic and Insulinemic Responses in Healthy Individuals
Condition: Glycemic Response
Study type: Interventional

Summary: 
      The objectives of this study are to compare the glycemic and insulinemic responses over 3
      hours elicited by 3 oatmeal varieties compared to each other and to controls of ready to eat
      and hot cereals.
    

Detailed description: 
      Participant eligibility will be screened at visit 1. The study will be a randomized,
      cross-over design. Participants will come to the study site on 5 separate occasions separated
      by a 2-day to 2-week washout period. Participants will arrive to the lab in a fasted state. 2
      fasting blood samples will be collected, and further blood sampled will be taken over a
      3-hour period post study product consumption.
    

Intervention name(s): Oatmeal
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Efficacy and Safety of Itopride vs Placebo in Heartburn
Condition: Heartburn
MeSH terms: Heartburn
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effects of itopride in patients with heartburn.
    


Intervention name(s): Itopride; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Traction Assisted Polypectomy of the Intestine
Condition: Colonic Polyps; Adenomatous Polyps
MeSH terms: Adenomatous Polyps; Polyps; Colonic Polyps
Study type: Interventional

Summary: 
      The purpose of the study is to verify if the ablation of lesions (polyps, adenomas) in the
      large (and small) intestine can be facilitated by using a traction on the lesions.
    

Detailed description: 
      We want to facilitate the ablation of lesions (polyps, adenomas) in the large (and small)
      intestine by using a traction assisted technique.

      The traction will be performed by using a haemoclip connected to surgical suture materials.
      The haemoclip will be fixed to the intestinal mucosa next to the lesion and a loop will be
      mounted to perform an endoscopic mucosal resection.

      The aim of the study is to show the feasibility of this technique.
    

Intervention name(s): traction assisted endoscopic mucosa resection
Intervention type(s): Device
Intervention description(s): A haemoclip is connected to suture material and will be fixed (next) to a polyp to allow traction and lifting the lesion in order to facilitate its resection with a loop.
Other intervention name(s): endoscopic polypectomy
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Gold Fish Exercises and Cervico-thoracic Postural Correction Training in Patients With TMJD
Condition: Temporomandibular Joint; Temporomandibular Joint Dysfunction
MeSH terms: Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional

Summary: 
      The aim of this randomized controlled trial is to determine the effect of Gold Fish exercises
      and cervico-thoracic postural correction training in patients with temporo-mandibular joint
      dysfunction to improve pain, ROM and maximum mouth opening of jaw.
    

Detailed description: 
      Goldfish Exercise works on the principle of pulsatile motion of Goldfish in water & thereby
      imitating the same motion for health benefits. It can be thought of stretching the fibrous
      bands, reducing TMJ stiffness & resulting in improvement of mouth opening. It would be
      beneficial to use this technique on daily basis and as far there are no contraindications of
      this exercise because it's done within the pain limits & further progression depends on the
      mouth opening of the patient.

      Posture can affect the three-dimensional movement of the jaw during opening which is seen
      most clearly in the slumped posture as reduced maximal mouth opening. While mouth opening and
      head extension are linked, there is variability in the amount of head extension when opening
      wide and the relationship between head extension and mouth opening is negated when opening in
      a slumped posture. This has implications for the association of neck dysfunction, posture,
      and temporo-mandibular joint disorder which should be explored further.
    

Intervention name(s): Gold Fish exercises; Cervico-thoracic postural correction training; Conventional PT treatment
Intervention type(s): Other; Other; Other
Intervention description(s): Specific exercise for the flexibility of TMJ that will target the Jaw muscles. Frequency: 3 times/week for 4 weeks Intensity: moderate intensity (pain free) Time: 30-45 minutes Type: Gold Fish exercises for jaw flexibility, pain and maximum mouth opening.; Cervico-thoracic postural correction training for upper thoracic and neck muscles.
Frequency: 3 times/week for 4 weeks Intensity: moderate intensity (pain free) Time: 30-45 minutes Type: Muscle energy technique to improve range of motion, pain and maximum mouth opening.; Conventional PT including Hot Pack for 10mins, Active-Passive neck Stretching Exercise + jaw Isometric Exercises.
Frequency: hold followed by 5secs rest. 2-3times for 3 times/week for 4 weeks, Intensity: moderate-high intensity (depending on pain tolerance) Time: 30-45 mins for Active-Passive neck Stretching.
Frequency: 3secs hold, 6 times repetitions for Isometric Exercises. Type: conventional treatment for pain, ROM, MMO.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Temporomandibular joint dysfunction.; Gold Fish exercises; Cervico-thoracic postural correction training
Neurodevelopment Outcome of Newborns Exposed to Zika Virus (ZIKV) in Utero
Condition: Microcephaly; Mental Retardation
MeSH terms: Zika Virus Infection; Microcephaly; Intellectual Disability
Study type: Observational

Summary: 
      This prospective cohort study will determine the natural history of fetal exposure to Zika
      virus (ZIKV) and its effects on the fetus and newborn with emphasis on neurodevelopment
      outcome. Exposure of the fetus will be determined by maternal symptomatology, RT-PCR ZIKV
      (blood and urine) and serologic test specific for ZIKV. Neonates will be classified according
      to trimester of infection and as exposed and unexposed to ZIKV.
    

Detailed description: 
      Infection with Zika Virus (ZIKV) is an emerging disease in South America and a serious public
      health problem due to a high prevalence of one of the vectors that transmit the virus, Aedes
      Aegypti, and the severe and sometimes fatal complications that can be generated in the fetus
      of women infected by the virus during their pregnancy. Retrospective studies have shown an
      association with microcephaly, cerebral calcifications, dysgenesis of the corpus callosum,
      and other anomalies of the central nervous system (CNS). The high risk of neurodevelopmental
      impairment in the exposed newborn is a major concern.

      The epidemiologic and neurobiological evidence supporting the link between infection of
      pregnant women, trimester of infection, and the development of such anomalies in the fetus is
      growing to the extent that the Center for Disease Control has officially made a statement
      supporting this association. Although the dimension of the public health impact is still
      unknown, limited prospective data makes counseling of pregnant women difficult, especially
      when they are considering termination of pregnancy.

      Given that evidence supporting the neurotropic quality of ZIKV and the potential variations
      of the effect the virus may have on the developing fetal brain according to the gestational
      age of infection, we have designed a prospective cohort study to determine whether exposure
      of the fetus to ZIKV in symptomatic mothers results in fetal CNS anomalies and/or impaired
      neurodevelopmental outcome of the newborn. As a secondary aim we will determine the effect
      gestational age has on severity of CNS anomalies and neurodevelopmental outcome.
    

Intervention name(s): Symptomatic pregnant women with positive RT-PCR ZIKV in serum or urine, or a positive serologic test specific for ZIKV
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ZIKV symptomatic and asymptomatic pregnant women in hyper endemic areas of ZIKV in Colombia
      
Biospecimen description: 
      Maternal serum Amniotic Fluid Urine CSF
    
Keywords: Pregnancy; Fetal Development; Child Development; Developmental Disabilities; Zika Virus Infection
Health Related Quality of Life Assessment In Egyptian Recipients After Living Donor Liver Transplantation
Condition: Health Related Quality of Life
Study type: Observational

Summary: 
      Health Related Quality of Life Assessment In Egyptian Recipients After Living Donor Liver
      Transplantation
    

Detailed description: 
      This Study Aims to Evaluate:-

        1. Quality of life after LDLT In Egyptian patients using short form 36 (SF - 36) score.

        2. Impact of post transplant medical and psychiatric complications on quality of life
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients who will undergo LDLT In Ain Shams Center For Organ Transplantation (ASCOT) in the
        next 6 months.
      
Keywords: Health Related Quality of Life (HRQL); Living Donor Liver Transplantation(LDLT)
Antiviral Therapy in Decompensated Hepatitis C Virus (HCV) Cirrhosis
Condition: Liver Cirrhosis, Experimental
MeSH terms: Hepatitis C; Liver Cirrhosis; Liver Cirrhosis, Experimental; Fibrosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To evaluate:

        1. the impact of combined antiviral therapy (Peginterferon plus ribavirin) on natural
           history of patients affected with HCV decompensated cirrhosis, after sustained
           virological response. A controlled study.

        2. safety and efficacy of antiviral therapy in this population by using a statistically
           significally number of patients as controls.
    

Detailed description: 
      Decompensated HCV cirrhosis is a relevant problem as its clinical evidences predisposes to an
      high mortality risk, with a survival rate of 50% at 5 years (1,2). Davis et. al processed a
      mathematical model of the natural history of chronic hepatitis C and projected the total
      number of cases with cirrhosis increased by more than 50% by 2010 and then plateaued (3). As
      a result, there will be a dramatic increase in the number of cases with complications of
      liver failure and decompensated events of cirrhosis will increase to 25% in 2010, 32% in
      2020, 36% in 2030, and 38% in 2040 (3, table 1).Liver transplantation is the treatment of
      choice but the limited number of organ donor makes not realizable for the major of patients.
      Furthermore, age over 65 years correlated disease is not accepted to enter into the list of
      liver transplant. To prevent these patients from worsening their liver disease has positive
      economic implications in terms of health care resources used as diagnostic tests, clinic
      visits, drug therapy, hospitalization for management of complications, and later on, liver
      transplantation, and indirect costs related to lost work time and impaired quality of life.
      our controlled study on antiviral treatment of decompensated cirrhotics has shown that HCV
      clearance by therapy can be life-saving, improves hepatic function, and reduces disease
      progression. Treatment should be encouraged in CTP classes A and B, and especially in
      patients infected by genotype 2. The benefit of treating patients with genotype 1 remains
      unproven.
    

Intervention name(s): peginterferon and ribavirin
Intervention type(s): Drug
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) in Children
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the safety and efficacy of clonidine alone or in
      combination with methylphenidate for children 7-12 years of age with attention-deficit,
      hyperactivity disorder.
    

Detailed description: 
      This trial will compare the benefits and side effects of two medications-clonidine and
      methylphenidate (MPH)-used alone or in combination to treat ADHD in children. MPH is
      FDA-approved for the treatment of ADHD symptoms in children, and clonidine is FDA-approved
      for the treatment of hypertension in adults. Stimulant medications such as MPH are known to
      be safe and effective for the treatment of many ADHD symptoms. Such medicines, however, do
      not cure the condition or improve all of the symptoms of ADHD, and the long-term
      effectiveness of these medications is not well-known. In this study the participants will be
      randomly selected to receive one of four treatments: 1.) clonidine; 2.) MPH; 3.) clonidine
      and MPH; or 4.) a placebo (which is not an active medication, but a substance that is thought
      to have no biological effect). The time participation in the study is 16 weeks.
    

Intervention name(s): clonidine; methylphenidate; placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Clonidine is FDA-approved for the treatment of hypertension in adults.; MPH is FDA-approved for the treatment of ADHD symptoms in children.; an inactive substance
Other intervention name(s): MPH
Intervention MeSH terms: Clonidine; Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder; ADHD; clonidine; methylphenidate; MPH