bioihbjkbjnl/mcl2 huggingface dataset:
Subcutaneous EEG in Epilepsy
Condition: Temporal Lobe Epilepsy
MeSH terms: Epilepsy; Epilepsy, Temporal Lobe
Study type: Interventional

Summary: 
      The study is a two-phase study, which aims to explore the uses of a novel electrode type in
      detecting epileptic seizures. The electrode is designed for subcutaneous implantation with
      long-term monitoring in mind.
    

Detailed description: 
      The problem of unrecognized seizures is common for certain types of epilepsy.
      Electroencephalography (EEG) is an excellent method for seizure identification and
      recognition, but until now, it has not been feasible to perform EEG recordings for more than
      a few days outside a hospital or laboratory. A novel device has been developed, which might
      remedy that. The device is a EEG-electrode for subcutaneous implantation connected to an
      external data storage device.

      The investigators in this study hypothesize that this device might be a useful tool for
      ultra-long-term epilepsy monitoring. The study aims to investigate that. While the device
      might be used to diagnose epilepsy, it is more likely to be a good seizure counting tool and
      that is what the study aims to determine.

      Subjects include patients with mesial temporal lobe epilepsy and high seizure frequency.
      These will have the device implanted. Study phase 1 is a proof of concept to determine
      whether the device is actually able to detect epileptic seizures. This will take place during
      admission and be performed as simultaneous recordings with ordinary scalp EEG and the
      investigational device. Study phase 2 is a home monitoring to prove that devices actually
      provides clinically useful information regarding seizures in an outpatient setting.

      The study requires 9 visits from each subject over the course of 4-6 months. The
      investigational device will be explanted after approximately 75 days of wear.
    

Intervention name(s): UNEEG implantable EEG electrode and data storage device
Intervention type(s): Device
Intervention description(s): The implantable EEG electrode will be implanted subcutaneously in the relevant temporal region by a certified neurosurgeon. The EEGgraphical data recorded will be transmitted transcutaneously to the data storage device via an inductive link, providing continuous data on brain activity.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Epilepsy; Seizure monitoring; Electroencephalography
Pharmacokinetic Evaluation of Moxifloxacin Administered Intravenously and Orally in Healthy Volunteers Who Have Had a Gastric Bypass
Condition: Gastric Bypass; Body Weight
MeSH terms: Body Weight
Study type: Interventional
Phase: Phase 4

Summary: 
      Roux-and-Y gastric bypass is one of the most common forms of bariatric surgery; due to a
      reduction in size of the stomach and intestine, the available surface area for the absorption
      of oral drugs is strongly decreased. This may lead to a reduced bioavailability resulting in
      a reduced efficacy of the drug. However, in literature there is no information available
      about the impact of bariatric surgery on the pharmacokinetics of moxifloxacin. This protocol
      evaluates the moxifloxacin plasma levels, the variability between subjects and the absolute
      bioavailability, after oral administration of 400 mg moxifloxacin in healthy volunteers who
      have had a gastric bypass at least 6 months ago and who now have a stable body weight.
    


Intervention name(s): moxifloxacin per IV; moxifloxacin per os
Intervention type(s): Drug; Drug
Intervention description(s): intravenous administration of 400 mg moxifloxacin (as a 1h-infusion); oral administration of 400 mg moxifloxacin in a single dose
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Roux-and-Y gastric bypass surgery; stable body weight
A Trial With Humanized TNFα Monoclonal Antibody Injection by Single Dose and Dose Escalation in Healthy Subjects
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a randomized, double-blind and placebo-controlled trial with healthy subjects.
      There are 6 Groups as follows: 5mg, 15mg, 30mg, 50mg, 75mg, 100mg, and each group includes12
      people. A single subcutaneous injection will be administrated starting from the low dose
      group (in accordance with 5mg, 15mg, 30mg, 50mg, 75mg, 100mg administered subcutaneously).
      Pharmacokinetics and pharmacodynamics data will be collected; drug metabolism and
      pharmacokinetics characteristics will be analyzed. Drug safety and tolerance for subjects
      will be evaluated.
    

Detailed description: 
      This study is a randomized, double-blind and placebo-controlled trial with healthy subjects.
      There are 6 Groups as follows: 5mg, 15mg, 30mg, 50mg, 75mg, 100mg, and each group includes12
      people. A single subcutaneous injection will be administrated starting from the low dose
      group (in accordance with 5mg, 15mg, 30mg, 50mg, 75mg, 100mg administered subcutaneously).
      Pharmacokinetics and pharmacodynamics data will be collected; drug metabolism and
      pharmacokinetics characteristics will be analyzed. Drug safety and tolerance for subjects
      will be evaluated.

      The study observed blood concentrations of the experimental drug at different time points
      after and before administration, TNFα before and after treatment at different time points
      will be observed as well.

      C-T curve will be drawn with blood drug concentration (c) and time (T) in the trial. At the
      same time, the investigators will draw the average plasma concentration curve. Compartmental
      and non compartmental model will be used to analyze the pharmacokinetic parameters of
      subjects. It will be judged with linear or nonlinear elimination by the correlation analysis
      of AUC, Cmax of different doses. In the meantime, adverse events, vital signs, physical
      examination, laboratory examination and ECG will be evaluated.
    

Intervention name(s): Humanized TNFα monoclonal antibody; placebo
Intervention type(s): Drug; Other
Intervention description(s): Subcutaneous injection of different doses for healthy people
Subcutaneous injection of different doses in healthy people; Subcutaneous injection of different doses for healthy people
Other intervention name(s): TNFα monoclonal antibody
Intervention MeSH terms: Antineoplastic Agents, Immunological; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: tolerance; safety and pharmacokinetic characteristics
A Multi-Center, Double-Masked Evaluation of the Efficacy and Safety of CSF-1 in the Treatment of Presbyopia
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 4-visit, multi-center, randomized, double-masked, parallel group study evaluating
      the safety and efficacy of CSF-1 in the treatment of presbyopia.
    

Detailed description: 
      This is a 4-visit, multi-center, randomized, double-masked, parallel group study evaluating
      the safety and efficacy of CSF-1 in the treatment of presbyopia. Approximately 150 subjects
      will be enrolled across 7 study centers in the United States. At Visit 2, subjects will be
      randomized 1:1:1 to one of three treatment arms: CSF-1, CSF-1 Component #1, or CSF-1
      Component #2. All subjects will dose twice a day in both eyes with a single drop of their
      assigned treatment for approximately 1 week. At Visit 3, subjects randomized to CSF-1 will
      now receive a different concentration of CSF-1, subjects randomized to CSF-1 Component #1
      will receive a different concentration of CSF-1 Component #1 and subjects randomized to CSF-1
      Component #2 will continue dosing with the same concentration of CSF-1 Component #2. All
      subjects will continue dosing twice a day in both eyes for approximately 1 week.
    

Intervention name(s): CSF-1; CSF-1 Component #1; CSF-1 Component #2
Intervention type(s): Drug; Drug; Drug
Intervention description(s): This treatment arm consists of 2 different concentrations of CSF-1. Subjects randomized to the CSF-1 treatment arm will receive their first dose of CSF-1 in-office at Visit 2. All subjects will dose twice a day in both eyes with a single drop for approximately 1 week. At Visit 3, subjects randomized to the CSF-1 arm will now receive a different concentration of CSF-1. Subjects will continue dosing twice a day in both eyes for approximately 1 week.; This treatment arm consists of 2 different concentrations of CSF-1 Component #1.
Subjects randomized to the CSF-1 Component #1 treatment arm will receive their first dose of CSF-1 Component #1 in-office at Visit 2. All subjects will dose twice a day in both eyes with a single drop for approximately 1 week. At Visit 3, subjects randomized to the CSF-1 Component #1 arm will now receive a different concentration of CSF-1 Component #1. Subjects will continue dosing twice a day in both eyes for approximately 1 week.; This treatment arm consists of a single concentration of CSF-1 Component #2. Subjects randomized to the CSF-1 Component #2 treatment arm will receive their first dose of CSF-1 Component #2 in-office at Visit 2. All subjects will dose twice a day in both eyes with a single drop for approximately 1 week. At Visit 3, subjects randomized to the CSF-1 Component #2 arm will continue dosing with the same concentration of CSF-1 Component #2. Subjects will continue dosing twice a day in both eyes for approximately 1 week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Genetic & Environmental Determinants Of Immune Phenotype Variance: Establishing A Path Towards Personalized Medicine
Condition: Individuality
Study type: Interventional

Summary: 
      The purpose of this study is to assess the determinants of immunologic variance within the
      general healthy population.
    

Detailed description: 
      Susceptibility to infections, disease severity, and response to medical therapies and
      vaccines are highly variable from one individual to another. While the question of variance
      in human populations continues to be a focal point of scientific research, medical practices
      and public health policies typically take a 'one size fits all' model to disease management
      and drug development.

      Individual heterogeneity in the immune response can have an enormous impact on the likelihood
      to respond to therapy or the development of side effects secondary to vaccine administration.
      Because of the complexity of immune responses in the individual and within the population, it
      has not been possible thus far to define the parameters (genetic or environmental) that
      constitute a healthy immune system and its natural occurring variability.

      Efforts to restore the 'personal' in medical care are the current challenge, and the driving
      vision of the project, to which the current study belongs.

      In order to realize the promise of personalized medicine, an in-depth understanding of the
      determinants of heterogeneity in host response to stress is required.
    

Intervention name(s): unique arm
Intervention type(s): Other
Intervention description(s): blood, nasal swab, skin biopsy, stool samples
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
The Effect of Teenage Maternity on Obstetrical and Perinatal Outcomes
Condition: Pregnancy
Study type: Observational

Summary: 
      The purpose of this study is to estimate the effect of maternal teenage on pregnancy and
      perinatal outcomes among Caucasian pregnant women.
    

Detailed description: 
      During the past decade in the United States, approximately 10 percent of teenage girls from
      15 to 19 became pregnant. According to the National Vital Statistics Report 2009 seventy of
      one thousand births in the United States accounted to teenagers from 15 to nineteen years of
      age during in 2005 and fell to forty per 1,000 women in 2006. In contrary, the overall
      teenage birth rate lay at twenty- two per 1,000 births in Massachusetts in 2007 ranging from
      seventy to thirteen per 1,000 women for Hispanic vs. white women aged 15- 19 years. Central
      European data showed equal results for teenage pregnancy birth rates. According to the German
      National Institute of Vital Statistics thirty-four of one thousand births in Germany
      accounted to teenagers younger than 20 years of age. This pattern is a source of concern
      since teenage mothers have an increased risk of having low-birth- weight babies, premature
      babies, and babies who die during the first year of life. Additionally, teenage mothers are
      more likely to suffer from other concomitant pregnancy diseases such as preeclampsia or
      anemia.

      Furthermore, teenage mothers are more likely than older mothers to be poor, less well
      educated, non- white, unmarried and they are less likely to have received early prenatal
      care. Dealing with pregnant adolescents therefore means a great challenge in modern
      obstetrics. Previous research has shown racial differences as well as weight differences for
      increased risk of adverse prenatal outcome among African Americans and teenagers. Taking into
      account the impact of race on pregnancy outcomes, our goal was to examine the relationship of
      young maternal age on obstetrical outcomes in a predominantly Caucasian central European
      teenaged population.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        retrospective cohort analysis of all deliveries at the Schleswig-Holstein University
        Hospital Center in Lübeck from January 2000 through December 2009
      
Keywords: teenage; pregnancy; obstetrical risk
Gene - Diet Interactions in Fatty Acid Desaturase 1 Gene
Condition: Fatty Acid
Study type: Interventional

Summary: 
      Interactions between genes and environment, are likely to be crucial in the development of
      the common diseases such as type 2 diabetes. It was recently shown that FADS1 and FADS 2
      genotypes are the strongest genes in a genome-wide analysis regulating serum fatty acid
      profile.The aim of this study is to test if subjects with the CC and TT genotypes of the
      FADS1 gene (rs174547) respond differentially to a diet supplemented with linoleic acid
      (substrate for FADS). We hypothesize that subjects with the TT genotype with more active
      desaturases will be more sensitive to dietary modification leading to more robust differences
      in serum FA profile, tissue inflammation and serum lipids.
    

Detailed description: 
      Lean and overweight subjects (BMI >20kg/m2 <29kg/m2 ) with CC and TT genotypes of FADS1
      polymorphism (rs174547) were recruited from the METSIM study (METabolic Syndrome in Men,
      currently >10000 men included from the population living in Kuopio). The potential
      participants were asked to contact study nurse if willing to participate. Twenty six subjects
      with CC genotype were selected after matching with thirty six subjects with the TT genotype
      for age, BMI and medication.

      Study diet were isocaloric following the habitual diet of the participants with a supplement
      of 30-50 ml (25-45 g) sunflower oil daily depending on body weight. Thus, approximately 16-28
      g (6 E%) LA daily were provided on top of the average intake of approximately 10-12 g (4.5
      E%). This dose of sunflower oil is not known to cause any side effects or adverse events and
      even higher doses have been safe.

      Food records were collected at the beginning (4 days) and during the third week of the study
      (7 days) to estimate daily intake of macronutrients and specifically of different fatty
      acids.
    

Intervention name(s): Sunflower oil
Intervention type(s): Dietary Supplement
Intervention description(s): Study diets were isocaloric following the habitual diet of the participants with a supplement of 30-50 ml (25-45 g) sunflower oil daily depending on body weight. Thus, approximately 16-28 g (6 E%) LA were provided daily on top of the average intake of approximately 10-12 g (4.5 E%).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: fatty acids, FADS gene, genotype, diet
Safety, Tolerability, Pharmacodynamic Effects and Preliminary Evidence for Efficacy of the Anti-Hypertension Vaccine CYT006-AngQb
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a multi-center, randomized, placebo-controlled, time-lagged, parallel-group study in
      healthy and hypertensive subjects to evaluate safety and tolerability of the vaccine
      CYT006-AngQb. The trial is double-blind for active vs. placebo within each treatment arm, but
      open with respect to AngQb dose escalation.

      In the first arm, 16 healthy normotensive volunteers are treated with a one dose regimen
      consisting of a single s.c. injection of 100µg of AngQb or placebo. Upon satisfying safety
      and tolerability profile, as judged by the independent safety monitoring board, arm two is
      enrolled.

      In arm two 36 patients with mild to moderate hypertension receive three s.c. injections of
      100µg CYT006-AngQb (24 patients) or placebo (12 patients). The second and third injections
      are given 4 and 12 weeks after the first injection, respectively. Upon satisfying safety and
      tolerability profile, as judged by the independent safety monitoring board, arm three is
      enrolled.

      In arm three 36 patients with mild to moderate hypertension receive three s.c. injections of
      300µg CYT006-AngQb (24 patients) or placebo (12 patients). The second and third injections
      are given 4 and 12 weeks after the first injection, respectively.

      The primary objective of the trial is to evaluate safety / tolerability of 3 dose regimens of
      CYT006-AngQb in healthy volunteers and patients with mild to moderate essential hypertension.
      Secondary objectives include the assessment of pharmacodynamic effects and their
      dose-response (immunogenicity and biomarkers of the renin-angiotensin system), and the
      exploration of clinical efficacy (effects on systolic and diastolic blood pressure)
    


Intervention name(s): CYT006-AngQb
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Resistance Training Effects on Gut Microbiome and Cardiometabolic Outcomes
Condition: Exercise Intervention
Study type: Interventional

Summary: 
      The overall objective of this study is to investigate the effects of resistance training on
      the gut microbiome and cardiometabolic outcomes in adults with overweight and obesity.
    

Detailed description: 
      The overall objective of this study is to investigate the effects of resistance training on
      the gut microbiome and cardiometabolic outcomes in adults with overweight and obesity.
    

Intervention name(s): Resistance training; Conventional physical activity guidelines
Intervention type(s): Behavioral; Other
Intervention description(s): Participants will undergo 6 weeks of supervised resistance training; Participants are given recommendations on physical activity guidelines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Gut Microbiome; Resistance Training; Physical Activity
Bioequivalence of Single Dose Fast Release Aspirin (1000 mg) Tablet Versus Single Dose of Two 500 mg Fast Release Aspirin Tablets
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to compare the bioavailability of a single dose of a
      new 1000 mg fast release ASA (acetylsalicylic acid) tablet with that of two tablets of a
      commercially available 500 mg fast release tablet and to test for bioequivalence of the new
      versus the commercial product in healthy adult subjects.
    


Intervention name(s): Acetylsalicylic acid (Aspirin, BAY1019036); Acetylsalicylic acid (Aspirin, BAY1019036)
Intervention type(s): Drug; Drug
Intervention description(s): One Fast Release Tablet containing 1000 mg acetylsalicylic acid; Two Fast Release Tablets containing 500 mg acetylsalicylic acid each
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Research of Berberine Hydrochloride to Prevent Colorectal Adenomas in Patients With Previous Colorectal Cancer
Condition: Colorectal Adenomas
MeSH terms: Adenoma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Experimental studies in animals and observational studies in humans suggest that
      fusobacterium nucleatum is associates with stages of colorectal neoplasia development, and
      Berberine Hydrochloride could rescue Fusobacterium nucleatum-induced colorectal tumorigenesis
      by modulating the tumor microenvironment. Whether regular Berberine Hydrochloride use may
      decrease the risk of colorectal adenomas, the precursors to most colorectal cancers is worth
      to further study.
    

Detailed description: 
      The prevalence of colorectal adenomas is high in our country, as is the incidence of
      colorectal cancer. It is well-known that colorectal adenomas are the precursor of colorectal
      cancer and that removing them will prevent colorectal cancer. Because most colorectal cancers
      arise from benign adenomas, adenomas have been used as surrogate end points in prevention
      trials. Berberine hydrochloride, which is an alkaloid extracted from Rhizoma coptidis, has
      been traditionally used in Chinese medicine to treat gastrointestinal infections, due to its
      antimicrobial properties. Previous clinical research and animal studies have demonstrated the
      anti-tumor action of Berberine hydrochloride. Persons with a history of colorectal cancer
      might constitute a group at higher risk for adenomas and thus be particularly suitable for a
      study of the chemopreventive effects of Berberine hydrochloride. Here, a randomized,
      double-blind, placebo-controlled trial was designed to determine whether the daily use of 300
      mg of berberine hydrochloride could decreases the occurrence of new colorectal adenomas among
      patients with a history of colorectal cancer.
    

Intervention name(s): Berberine hydrochloride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): patients take the Berberine hydrochloride 300mg tablet by mouth, 2 times a day with 3 years.; pill manufactured to mmic Berberine hydrochloride 100mg tablet
Other intervention name(s): Berberine hydrochloride tablet ("Sine Tianping"); Placebo (for Berberine hydrochloride)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention