bioihbjkbjnl/mcl2 huggingface dataset:
Pegylated Interferon Plus Ribavirin in Treating Older Patients With Chronic Hepatitis C
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      Combination therapy with pegylated interferon-alpha plus ribavirin has greatly improved the
      treatment efficacy and is the mainstream of treatment for chronic hepatitis C infection. The
      efficacy and safety of pegylated interferon-alpha plus ribavirin combination therapy and its
      impact on the outcome in older patients with chronic hepatitis C deserve to be elucidated.

      The purposes of this study are:

        1. To evaluate the efficacy of pegylated interferon-alpha 2a plus ribavirin combination
           therapy in older patients with chronic hepatitis C

        2. To investigate the safety of pegylated interferon-alpha 2a plus ribavirin combination
           therapy in older patients with chronic hepatitis C
    

Detailed description: 
      A prospective, hospital-based, case-control study enrolling 70 chronic hepatitis C patients
      who are 65 to 80 years of age and other sex- and HCV genotype-matched 140 chronic hepatitis C
      patients who are 50 to 64 years of age will be conducted for comparison. The 210 patients
      chronic hepatitis C patients will receive pegylated interferon-alpha plus ribavirin
      combination therapy. Genotype 1 infected patients will received 48 weeks of treatment and
      genotype non-1 patients will received 24 weeks of treatment. Another 40 HCV-1 infected
      patients who are 65-80 years of age and have a rapid virological response ( defined as
      seronegative of HCV RNA at week 4 of treatment) will receive 24 weeks of treatment and are
      enrolled for comparison since Jan 2008. The primary outcome measurement is sustained
      virological response and safety.
    

Intervention name(s): pegylated interferon alpha and plus ribavirin; pegylated interferon alpha and plus ribavirin; pegylated interferon alpha and plus ribavirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day, 24weeks of treatment for genotype non-1 infected patients and 48 weeks of treatment for genotype 1 infected patients, follow up for 24 weeks; pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day, 24weeks of treatment for genotype non-1 infected patients and 48 weeks of treatment for genotype 1 infected patients, follow up for 24 weeks; pegylated interferon alpha 180 ug/week and ribavirin 1000-1200 mg/day for 24 weeks
Other intervention name(s): PEGASYS®; PEGASYS®; PEGASYS®
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Peginterferon alfa-2a
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic hepatitis C; sustained virological response; rapid virological response; peginterferon; ribavirin; old age
Effect of a High-fat Meal on the Pharmacokinetics of Hetrombopag and Mass Balance Study in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, randomized, two-period, two-treatment (single doses of 7.5 mg hetrombopag
      fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on
      the pharmacokinetics of hetrombopag and mass balance study in 12 healthy subjects.
    


Intervention name(s): Hetrombopag Olamine
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Subjects
Investigation of the Effect of BONISTEIN(R) Bone Blend on Bone Mineral Density/Content and Biomarkers of Bone Health
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      The purpose of this study is to obtain information about the effect of a combination of
      genistein, PUFAs, vitamin K and D (BONISTEIN(R) bone blend) on bone health, determined as
      bone mass density/content and bone biomarkers after 6-months treatment in 70 healthy
      postmenopausal women. In addition, safety and tolerability will be investigated.
    

Detailed description: 
      Osteoporosis is the most frequent disease of the skeletal system with approximately one third
      of all postmenopausal women being currently affected in the USA and in Europe. The role of
      nutrition in bone health has been increasingly recognized in the last couple of years. In
      particular nutrients such as isoflavones, vitamins D and K as well as polyunsaturated fatty
      acids (PUFA) have been implicate in bone health recently.

      The DSM Nutritional Products Ltd product BONISTEIN(R) is a synthetic genistein. Its genistin
      aglycone purity is above 99 % and the appearance is a beige crystal.

      In addition to the primary and secondary outcomes, body composition, genistein plasma levels,
      diet and physical activity are assessed.
    

Intervention name(s): BONISTEIN(R) bone blend; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 Capsules per day over a period of 6 months; 2 capsules per day over a period of 6 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Soy Isoflavones, Bone Mineral Density, Bone Mineral Content, postmenopausal Women, Bone Markers, Bone Health, Phytoestrogens
Can the Hypertrophy of Contralateral Testis Predict the Absence of the Non-palpable Testis in the Boys Aged From 6months to 18months of Age ?
Condition: Focus of Study
MeSH terms: Hypertrophy
Study type: Observational

Summary: 
      The aim of this study is to verify whether the hypertrophy of contralateral testis may
      predict the absence of the non-palpable testis in the boys younger than 24months of age.
      According to the previous studies of other countries, the large size of the contralateral
      testis of the nonpalpable testis has positive correlation woth the weak viability of the
      affected testis. We are going to evaluate this hypothesis with prospective study. 3 groups
      are going to be enrolled into this study ; non-palpable testis group(Group1), palpable but
      not normally descended testis group(group2) and control group(group3). The size of testis
      will be measured with Ultrasound and the length, width and the height will be measured before
      surgery at outpatient department. For the group 1 & 2, the viability of the affected testis
      will be evaluated and compared after surgery. In addition the comparison with normal control
      group is also going th be conducted.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        totally, 72 children : unpalpable testis : 24 children, palpable undescended testis : 24
        children, normal control : 24 children
      
Keywords: cryptorchidism, undescended testis, hypertrophy of contralateral testis
Study of Cetuximab to Treat Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of cetuximab combined with
      FOLFIRI in patients with advanced gastric cancer who failed first-line chemotherapy
    

Detailed description: 
      Up to now, although FU based, cisplatin based and taxane based regimen, and ECF regimen have
      been suggested as the first line therapy for A/MGC by FDA, there is no standard regimen for
      patients with A/MGC as second line treatment. Based on the promising results of cetuximab
      combined with FOLFIRI in metastatic colorectal cancer, we design this clinical trial to
      evaluate the efficacy and safety of cetuximab combined with FOLFIRI for A/MGC patients as a
      second line treatment.
    

Intervention name(s): cetuximab
Intervention type(s): Drug
Intervention description(s): cetuximab 400mg/m2 as initial dose, subsequently at 250mg/m2 weekly dose. CPT-11 180 mg/m2 CF 200 mg/m2 5Fu 400mg/m2 bolus, followed by 2.4g/m2 continuously intravenous infusion for 46 hours, days 1 and 15, every 4 weeks per cycle
Other intervention name(s): treatment group
Intervention MeSH terms: Cetuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Time to Progression; Toxicity; Overall survival; Response rate; Quality of live
Effects of Plyometric Training on Endurance and Explosive Strength in Cricket Players
Condition: Sports Physical Therapy
Study type: Interventional

Summary: 
      This study will help to understand the effects of plyometric training on endurance and
      explosive strength in cricket players.
    

Detailed description: 
      It will consist of combination of plyometric training with warm up and cool down including
      Squat to Squat Jump, Lunge to Plyo Lunge, Step Jack to Star Jumps, Plank to Plyo Spider
      Lunge, Plank to Frogger Frequency = 2 days per week for 2 weeks and then 4 days per week
      after 2nd week to 4th week, Intensity =500 jumps, Time = 30 min.
    

Intervention name(s): Plyometric training with warm up and cool down; Conventional training with warm up & cool down
Intervention type(s): Other; Other
Intervention description(s): These Include Squat to Squat Jump, Lunge to Plyo Lunge, Step Jack to Star Jumps, Plank to Plyo Spider Lunge, Plank to Frogger Frequency = 2 days per week for 2 weeks and then 4 days per week after 2nd week to 4th week Intensity =500 jumps Time = 30 min; These include Squats, Single leg squat, Cork hip lift, Press ups, Normal warm-up time 15 min before game.
Other intervention name(s): These Squat to Squat Jump, Lunge to Plyo Lunge, Step Jack to Star Jumps, Plank to Plyo Spider Lunge, Plank to Frogger
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Can Intermittent Fasting Mimic the Metabolic and Cardiovascular and Anti-aging Effects of Calorie Restriction?
Condition: Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of Intermittent Fasting study is to investigate whether intermittent fasting
      could decrease the chronic inflammation levels in overweight/obese people.
    

Detailed description: 
      The primary objective of this study is to determine whether or not IF reduces the level of
      chronic inflammation as evidenced by a decrease in high sensitive C-reactive protein (hsCRP),
      as the main outcome measure
    

Intervention name(s): Intermittent Fasting group; control group
Intervention type(s): Other; Other
Intervention description(s): Intermittent fasting for 12 months; usual diet for 6 months and intermittent fasting for other 6 months
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intermittent fasting; obesity; calorie restriction
The Laryngeal Tube Suction Versus Endotracheal Tube for Ventilation in Gynecological Laparoscopic Surgery
Condition: Focus Groups
Study type: Interventional

Summary: 
      This study the investigators compare peak airway pressure (PAP), expire tidal volume (TV),
      end tidal CO2 (ETCO2), SpO2, mean arterial pressure (MAP) and heart rate (HR) after the
      insertion of laryngeal tube suction or endotracheal tube in patients undergoing elective
      gynecological laparoscopic surgery.
    

Detailed description: 
      Background:

      For standard procedure, the endotracheal tube is used to ventilate the anesthetized patients
      who undergo gynecological laparoscopic surgery that increase intrabdominal pressure. Now
      there is a new supraglottic airway device, laryngeal tube suction (LTs) can be use instead of
      ETT.

      Objective This study the investigators compare peak airway pressure (PAP), expire tidal
      volume (TV), end tidal CO2 (ETCO2), SpO2, mean arterial pressure (MAP) and heart rate (HR)
      after the insertion of laryngeal tube suction or endotracheal tube in patients undergoing
      elective gynecological laparoscopic surgery.

      Material and methods Prospective single blinded randomized control trial, the patients were
      divided into two groups, LTs group and ETT group n = 60 for each group. All patients were
      induced anesthesia with fentanyl 1-2 mcg/kg, propofol 2 mg/kg, vecuronium 0.1 mg/kg then
      maintained anesthesia with air : oxygen 30%. Respirator setting are tidal volume 10 ml/kg,
      I/E 1:2 adjust RR base on ETCO2 keep ETCO2 35-40 mmHg.

      Results No statistical difference in demographic data between groups. PAP and ETCO2 in the
      LTs group were significant higher than ETT group in the first 5 and 10 minutes but no
      statistically significant after 10 minutes until the end of operation. No statistically
      significant in TV and SpO2 between groups. In ETT group MAP and HR after insertion are
      significant higher than LTs group, no statistically significant about postoperative
      complication such as sorethroat, hoarseness and nausea vomiting.

      Conclusion LTs can be used in gynecological laparoscopic surgery like ETT.
    

Intervention name(s): laryngeal tube (VBM Medizintechnik, Sulz, Germany)
Intervention type(s): Device
Intervention description(s): laryngeal tube suction number 3 and 4
Other intervention name(s): The laryngeal tube(VBM Medizintechnik, Sulz, Germany)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: laryngeal tube suction; gynecology; laparoscopic surgery
Analysis of Post-Translational Modifications of a Critical Protein Implicated in Amyotrophic Lateral Sclerosis
Condition: ALS
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Observational

Summary: 
      The purpose of this research study is to discover and quantitate the differences in
      post-translational modifications found in the Cu, Zn superoxide dismutase (SOD1) of patients
      with amyotrophic lateral sclerosis (ALS) as compared to healthy individuals. SOD1 is a known
      genetic cause of ALS. With certain mutations, SOD1 gains a toxic function which leads to
      motor neuron death.
    

Detailed description: 
      Amyotrophic Lateral Sclerosis (ALS) is a devastating neurodegenerative disease in which
      mutations in human Cu, Zn Superoxide Dismutase (SOD1) have been identified as a cause of
      familial ALS (FALS) cases.1-2 It has been shown that mutant SOD1 develops a novel toxic
      function through experiments demonstrating that many disease mutants maintain enzymatic
      activity, SOD1-null mice do not exhibit ALS symptoms, and co-expressed wild type protein does
      not rescue the disease-state.7-11 The majority of cases, however, are not caused directly by
      mutations of SOD1, instead being caused by a poorly understood interplay of several genes as
      well as environmental factors, which is often referred to as sporadic ALS (SALS).3 It has
      been found that FALS and SALS share similar pathology. 4-6 The hSOD1 protein aggregates
      characteristic of FALS have also been found in SALS patients, furthering the evidence that
      hSOD1 has an important role in the etiology of ALS in sporadic ALS patients.16-19 The exact
      mechanism of SOD1-associated toxicity has not yet been elucidated though many disease mutants
      have been shown to destabilize the SOD1 dimer. In this study we aim to compare the levels of
      SOD1 post-tra slational modifications in ALS patients to levels in healthy donors and to
      determine if there are distinct patterns of protein glutathionylation or phosphorylation. Our
      overall goal is to elucidate a direct mechanism of toxicity in SALS as well as identify
      potentially critical triggers
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        SALS patients SOD1 associated FALS patients Healthy control
      
Biospecimen description: 
      A portion of this sample will be stored for future use in study of ALS and how the critical
      protien affects the disease progression long term. This sample will be stored de-identified;
      therefore will not be linked to any identifying informaton about the subject. Sample will be
      stored at the UNC biophysics and Biochemistry lab indefinitely
A Physical Activity Program to Disrupt Sedentary Time in Older Latinos
Condition: Sedentary Behavior; Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      To test the feasibility of an intervention designed to replace sedentary time with physical
      activity in older Latinos, delivered in their homes to improve cognitive function and brain
      connectivity.
    

Detailed description: 
      After being informed of the study and potential risks, all patients giving informed consent
      will undergo a focused phone interviews, followed by screening to determine eligibility.
      Participants that meet inclusion criteria will undergo baseline cognitive function testing
      via video (following NIH toolbox guidelines for remote cognitive function assessment),
      followed by a one week measurement of sedentary time using a physical activity monitor
      (actigraphy). At week 0, participants will be randomized into either a physical activity
      group to break up sedentary time or activity guidelines only in a 1:1 ratio. Follow up occurs
      at 6 weeks using the same measures as baseline.
    

Intervention name(s): Ecological Momentary Intervention
Intervention type(s): Behavioral
Intervention description(s): Participants will wear a Fitbit that has been programmed to deliver a notification (a buzz) when activity has ceased for more than 10 minutes. They will receive suggestions on their Illumivu mEMA smartphone app on how to replace sitting time with PA such as standing up 5 times or taking 20 steps, or even performing a short (20 seconds) preferred dance routine. Fitbit data will be captured in real-time via the iCardia platform. Participants will receive reminders from their smartphones to enter real-time feedback on activity options selected and how successful they were in adopting the option. These data will allow tracking of underlying preferences for behaviors and to tailor the program accordingly.
Other intervention name(s): Illumivu mEMA
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a pilot randomized, controlled trial of a 6-week intervention for feasibility. Outcome measures will be obtained at baseline and at 6-weeks. Behavior choices and preference data will be continuously captured during the intervention. We will randomize 80 older Latinos from the Chicago Latino community to either an ecological momentary intervention using fitbits (n=40) or to physical activity guidelines (n=40).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sedentary Behavior; Physical Activity; Cognitive Health; Older Adults; Latinos
Efficacy of PAP Therapy on Blood Pressure
Condition: Obstructive Sleep Apnoea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The aim of the study was to determine the long term effects of compliance with positive
      airway pressure therapy on blood pressure in both hypertensive and normotensive patients with
      obstructive sleep apnoea hypopnoea syndrome.
    

Detailed description: 
      Scientific data about the causal role of obstructive sleep apnoea hypopnoea syndrome (OSAHS)
      in the development of systemic hypertension and the effects of positive airway pressure (PAP)
      treatment on blood pressure (BP) control are continuously increasing; however they are
      controversial. We aimed to determine the long term effects of compliance with PAP therapy on
      BP in both hypertensive and normotensive patients with OSAHS.
    

Intervention name(s): positive airway pressure (PAP)
Intervention type(s): Device
Intervention description(s): Positive Airway Pressure (PAP) is a non-invasive machine providing air pressure f to prevent the collapse of the oropharyngeal walls and the obstruction of airflow during sleep, which occurs in obstructive sleep apnea hypopnea syndrome.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Safety and Tolerability of a Rapeseed Food Ingredient
Condition: Food Safety
Study type: Interventional

Summary: 
      The study is designed to assess the safety and tolerability of a novel food ingredient
      produced from rape seeds supplied as a snack-bar in a 4-week controlled intervention.
    

Detailed description: 
      An 4-week randomized, double-blind, controlled, parallel-group intervention for assessment of
      safety and tolerability of a novel rape seed ingredient (RI) followed by a 2-week follow-up
      period. Baseline measures for digestive symptom frequency questionnaire (DSFQ), blood safety
      tests and body mass index (BMI) will be collected at screening visit. At the randomization
      visit, participants' eligibility will be confirmed, and they will be randomly allocated into
      2 parallel groups consuming either 20 g (test group) or 0 g (control group) of RI within 2
      daily snack bars. During the intervention and follow-up periods participants will bi-weekly
      respond to a GI symptom questionnaire including DSFQ, stool frequency and stool consistency,
      and palatability items. At the end of the intervention period (week 4) a clinic visit
      including BMI and AE recording and blood safety tests will be held.
    

Intervention name(s): Rapeseed ingredient (RI); Control product without added RI
Intervention type(s): Other; Other
Intervention description(s): 2 snack bars daily containing 10 g of RI each.; 2 snack bars daily containing 0 g of RI.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: parallel-group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Rapeseed; Ingredient; Safety; Tolerability