bioihbjkbjnl/mcl2 huggingface dataset:
Intestinal Microbiota in Patients Before and After Bariatric Surgery and Healthy Controls
Condition: Obesity
Study type: Interventional

Summary: 
      Studying obesity and metabolic syndrome attention is focused more and more on gut microbiota.
      In humans and animals, bariatric surgery (mainly gastric bypass surgery) lead to alterations
      of gut microbiota, which seem to be favourable. In this study the investigators aim to
      examine the effect of different bariatric procedures on composition of gut microbiota.
    

Detailed description: 
      The human gastrointestinal tract is home to an extremely numerous and diverse collection of
      microbes communities, collectively termed the "intestinal microbiota". This amazingly complex
      and poorly understood group of communities has an enormous impact on humans. Indeed,
      microbiota is considered to play a number of key roles in the maintenance of host health,
      including aiding digestion of otherwise indigestible dietary compounds, synthesis of vitamins
      and other beneficial metabolites, immune system regulation and enhanced resistance against
      colonization by pathogenic microorganisms. Conversely, the intestinal microbiota is also a
      potent source of antigens and potentially harmful compounds. Schematically, humans can be
      considered to exist in a state of natural balance with their microbial inhabitants. A shift
      in the balance of microbiota composition such that it may become deleterious to host health
      is termed "dysbiosis". Dysbiosis of the gut microbiota has been implicated in numerous
      disorders, ranging from intestinal such as inflammatory bowel diseases and colorectal cancer
      to disorders with more systemic effects such as diabetes, obesity, insulin resistance and
      steatohepatitis. The link between the microbes in the human gut and the development of
      obesity, cardiovascular disease and metabolic syndromes, such as type 2 diabetes, is becoming
      clearer but, because of the complexity of the microbial community, the functional connections
      are less well understood.

      In humans and animals, bariatric surgery (mainly gastric bypass surgery) lead to alterations
      of gut microbiota, which seem to be favourable. In this study the investigators aim to
      examine the effect of different bariatric procedures on composition of gut microbiota.
    

Intervention name(s): Gastric Bypass or Sleeve gastrectomy
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Dermatological Assessment of Primary Dermal Irritability Accumulated, Sensitization, Photoallergy and Phototoxicity.
Condition: Sensitivity, Contact
MeSH terms: Dermatitis, Phototoxic; Dermatitis, Photoallergic; Dermatitis, Contact
Study type: Interventional

Summary: 
      This is a clinical study for health care product safety assessment. The research is going to
      conducted with 55 subjects, aged 18 to 70 years. The product is applied on the right and/or
      left participant back. After a wash out, the product is reapplied. Medical evaluation will be
      available throughout the study to assess possible adverse events. The main of the study is to
      observe the effects of the application of the product on the skin and prove the absence of
      irritability and/or allergy, photoallergy and phototoxicity.
    

Detailed description: 
      Subjects phototypes I to IV (according to Fitzpatrick classification). The products is
      applied over semi-occlusive dressings, remaing in contact with the skin.
    

Intervention name(s): Hyaluronic Acid Gel
Intervention type(s): Other
Intervention description(s): Health care product - to be apllied on the subject's skin
Intervention MeSH terms: Hyaluronic Acid
Intervention model: Single Group Assignment
Intervention model description: Clinical trial, single-arm
Masking: None (Open Label)
Primary purpose: Other
A Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RG1662 in Healthy Subjects
Condition: Healthy Patient Study
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is being conducted to investigate the effect of itraconazole treatment in the
      pharmacokinetics of RG1662. It is also to evaluate the exposure of RG1662 vs. QTc response
      relationship and the safety and tolerability of RG1662 when given in combination with
      itraconazole in healthy subjects.
    


Intervention name(s): RG1662; itraconazole
Intervention type(s): Drug; Drug
Intervention MeSH terms: Itraconazole
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Practice of AECOPD Management in China
Condition: Acute Exacerbation of Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      The purpose of this study is observe clinical practice including glucocorticoids treatment in
      AECOPD in China.
    

Detailed description: 
      It is widely recognized that the global social and economic burden of Chronic obstructive
      pulmonary disease (COPD) is high; affecting an estimated 64 million people worldwide. It was
      reported the prevalence of COPD in China population over 40 years old is about 8.2% (Zhong
      Nanshan et al, 2007). According to the report on China Chronic Disease, COPD is the second
      disease of Disability Adjusted Life Years. The economic burden of COPD is tremendous in
      China. Cost analysis in 2006 showed that every COPD patient in urban would pay 1732.24 $ on
      medical cost every year, indirect cost on nurse and traffic is 231.6 $, total cost would
      account for 40% of average family income in 2006(Chiang CH.,2008).AECOPD is one of most
      important cause leading to COPD death. Corticosteroid is essential for AECOPD management and
      recommended by domestic and international guidelines. But it shows that corticosteroid use
      for treating AECOPD in China is around 70% from market research in big hospitals, and less
      report about how steroid is used for AECOPD management was published, including distribution,
      dosage, treatment duration, etc. The healthcare resources utilization for treating AECOPD in
      China is also unclear.
    

Observational model: Case-Crossover
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The patient population will be ≥40 years of age, received hospitalization due to AECOPD
        since Sep, 2013. The patients should be diagnosed by GOLD 2013 as COPD at least 3 months
        before AECOPD based on treating physician judgment.
A Study to Investigate Pharmacokinetic Drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin
Condition: Hypertension; Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, open label, two-cohort, single-sequence, crossover study
    

Detailed description: 
      This is a phase 1, open label, two-cohort, single-sequence, crossover study to investigate
      the pharmacokinetic drug interaction and safety of Telmisartan/Amlodipine and Rosuvastatin in
      healthy male volunteers.
    

Intervention name(s): Twynsta 80/5mg; Crestor 20mg
Intervention type(s): Drug; Drug
Intervention description(s): Hypertension; Hyperlipidemia
Other intervention name(s): Telmisartan/Amlodipine 80/5mg; Rosuvastatin 20mg
Intervention MeSH terms: Amlodipine; Telmisartan; Telmisartan amlodipine combination; Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Laryngeal Mask, Video Laryngoscopy
Condition: Difficult Intubation
Study type: Observational

Summary: 
      LMA insertion provide an intact airway for many surgeries during general anesthesia . LMA
      insertion technique was defined when it was first produced by Archie Brain . Accordingly, it
      is recommended to advance the device to the level where resistance is felt blindly. However,
      placing LMA may not always be smooth and uncomplicated. Thus, gas leaks may occur and
      intragastric pressure increase may occur due to gastric insufflation. To overcome these
      difficulties, the placement of the LMA under direct vision using a laryngoscope has been
      described in several studies . Previous studies have shown that the reliability of the
      laryngeal mask can be demonstrated by the oropharyngeal cuff leak test . In addition, the
      classification of the image of the laryngeal structures mediated by fiberoptic imaging and
      vocal cords from the LMA gives us information about the availability of effective positive
      pressure ventilation.
    

Detailed description: 
      LMA insertion provide an intact airway for many surgeries during general anesthesia . LMA
      insertion technique was defined when it was first produced by Archie Brain . Accordingly, it
      is recommended to advance the device to the level where resistance is felt blindly. However,
      placing LMA may not always be smooth and uncomplicated. Thus, gas leaks may occur and
      intragastric pressure increase may occur due to gastric insufflation. To overcome these
      difficulties, the placement of the LMA under direct vision using a laryngoscope has been
      described in several studies . Previous studies have shown that the reliability of the
      laryngeal mask can be demonstrated by the oropharyngeal cuff leak test . In addition, the
      classification of the image of the laryngeal structures mediated by fiberoptic imaging and
      vocal cords from the LMA gives us information about the availability of effective positive
      pressure ventilation.In cases where difficulties are found in laryngeal mask placement, using
      direct laryngoscope or videosingoscope, placement is frequently applied in anesthesia
      practice. Kim GW et al investigated LMA placement with direct laryngoscope. However, there is
      no study investigating the effectiveness of videongoscopes. Videoingoscopes have wide viewing
      angles through their cameras located at the blade tips. For this reason, we think that it
      will be advantageous in placing a laryngeal mask.
    

Intervention name(s): larengeal mask insertion with video laryngoscopy; laryngeal mask insertion
Intervention type(s): Device; Other
Intervention description(s): it is a method of inserting a laryngeal mask into the airway with videolaryngoscopy; laryngeal mask is a method of inserting atube into the upper airway
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ASA1,2,3 group patients to insertion of laryngeal mask
      
Keywords: laryngeal mask
The Clinical Effect of MK0476 With Concomitant Administration of and Removal of Inhaled Beclomethasone in Asthmatic Patients (0476-029)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will investigate the additive effect of montelukast (MK0476) taken along with
      inhaled beclomethasone versus inhaled beclomethasone alone.
    


Intervention name(s): montelukast sodium; beclomethasone; Placebo inhaler; placebo tablet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 10 mg tablet taken once daily at bedtime for 16 weeks; 200 ug inhaled, taken twice daily for 16 weeks; placebo inhaler taken twice daily for 16 weeks; placebo tablet taken once daily at bedtime for 16 weeks
Other intervention name(s): MK0476
Intervention MeSH terms: Beclomethasone; Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: chronic asthma
Fluid Immersion Simulation (FIS) System Versus Air Fluidized Bed (AFB) System for Pressure Ulcers
Condition: Pressure Ulcer
MeSH terms: Pressure Ulcer; Ulcer
Study type: Interventional

Summary: 
      The primary objective is to compare the efficacy of the FIS on closure rate to the AFB after
      2 weeks of operative debridement and closure.
    

Detailed description: 
      Secondary Objectives:

        1. Compare the complication rate in each treatment group during the acute postoperative
           period (2 weeks).

        2. Comparisons of the inflammatory and bacterial microbiomes of pressure ulcers following
           surgical therapy.

        3. Comparisons of baseline patient characteristics and their relationship to both early and
           late pressure ulcer recurrence, and complication rates.

        4. Assessment of outcomes and complications associated with flap technique and surgeon
           guided descriptions of the operative closure.

        5. Compare the absolute costs associated with the FIS System against AFB system.

        6. Compare the acceptance of each system by subjects and nursing staff, including the
           parameter of patient comfort at 7 and 14 days postoperative.

        7. Assessing the incidence of complications and additional treatments needed following the
           two week study period.
    

Intervention name(s): Fluid Immersion Simulation System; Air Fluidized Bed System
Intervention type(s): Device; Device
Intervention description(s): Dolphin Fluid Immersion Simulation® System Mattress will be used; Air Fluidized Bed (Clinitron) will be used.
Other intervention name(s): FIS, Dolphin; AFB, Clinitron
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1:1 allocation ratio
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: support; flap; pressure; surface; closure; ulcer
Development and Validation of Deep Neural Networks for Blinking Identification and Classification
Condition: Blinking; Deep Learning
Study type: Observational [Patient Registry]

Summary: 
      Primary objective of this study is the development and validation of a system of deep neural
      networks which automatically detects and classifies blinks as "complete" or "incomplete" in
      image sequences.
    

Detailed description: 
      This method is based on iris and sclera segmentation in both eyes from the acquired images,
      using state of the art deep learning encoder-decoder neural architectures (DLED). The
      sequence of the segmented frames is post-processed to calculate the distance between the
      eyelids of each eye (palpebral fissure) and the corresponding iris diameter. Theses
      quantities are temporally filtered and their fraction is subject to adaptive thresholding to
      identify blinks and determine their type, independently for each eye. The two DLEDs were
      trained with manually segmented images and the post-process was parameterized using a
      4-minute video. After DLED training, the proposed system was tested on 8 different subjects,
      each one with a 4-10-minute video. Several metrics of blink detection and classification
      accuracy were calculated against the ground truth, which was generated by 3 independent
      experts, whose conflicts were resolved by a senior expert. Two independent blink
      identifications are assumed to be in agreement, if and only if there is sufficient temporal
      overlapping and the type of blink is the same between the DLED system and the ground truth.
    

Intervention name(s): Comparison of the proposed artificial network with the ground truth
Intervention type(s): Diagnostic Test
Intervention description(s): Both eyes will be included for each study participant. Participants watched a 4-10-minute video in standard mesopic environmental lighting conditions at 3.5m viewing distance. Simultaneously, all blinking moves will be recorded through a web infrared camera.
The proposed system was tested on the 8 different subjects. Several metrics of blink detection and classification accuracy were calculated against the ground truth, which was generated by 3 independent experts, whose conflicts were resolved by a senior expert. Two independent blink identifications are assumed to be in agreement, if and only if there is sufficient temporal overlapping and the type of blink is the same between the DLED system and the ground truth.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients aged from 18 to 75 years with Uncorrected Distance Visual Acuity ≥ 5/10
      
Keywords: deep learning; DeepLabv3+; iris and sclera segmentation; eye blink detection; complete and incomplete blink classification
Depression In Juvenile Diabetics
Condition: Depression; Diabetes Mellitus, Insulin-Dependent
MeSH terms: Diabetes Mellitus, Type 1; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Depression is one of the most common emotional problems among youths with insulin dependent
      diabetes mellitus (IDDM). It has been shown that depression in youths with IDDM lasts a while
      and may have a role in later complications of the medical condition. And yet, there are no
      psychological interventions appropriate for such youngsters. The purpose of this study is to
      modify a treatment called ''Contextual Psychotherapy'' (that has been developed for depressed
      youngsters) in order to address special needs of depressed youths with IDDM, and to ''pilot
      test'' the treatment. The youngsters to be recruited are those being cared for at the
      Diabetes Clinic of the Children's Hospital of Pittsburgh. The treatment includes a 3- month
      phase (16 sessions), followed by a 3-month ''booster'' phase (3 sessions), and two later
      follow-up evaluations.
    


Intervention name(s): psychotherapy
Intervention type(s): Behavioral
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: depression
Transcutaneous Non-invasive Stimulation of the Vagus Nerve for the Treatment of Difficult-to-treat Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional

Summary: 
      The aim of the study is to prove the feasibility and safety of transcutaneous, electrical
      stimulation of the vagus nerve in patients with difficult-to-treat forms of epilepsy.
    


Intervention name(s): T-VNS® Stimulator cM02 (Transcutaneous Stimulation of the Vagus Nerve)
Intervention type(s): Device
Intervention description(s): daily, transcutaneous, electrical stimulation of the vagus nerve by the t-VNS device for a period of 9 months
Other intervention name(s): T-VNS® Stimulator cM02
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: seizure disorder,; seizures,; convulsions,; grand mal,; petit mal,; absence seizures,; repeated seizures,; children's seizures,; secondary epilepsy,; symptomatic epilepsy,; generalized seizures,; partial seizure,; focal seizure,; partial complex seizure,; anticonvulsant medication
Investigation of the Effect of Specially Designed Insoles for Flat-footed Patients
Condition: Flat Foot [Pes Planus] (Acquired), Unspecified Foot
MeSH terms: Flatfoot
Study type: Interventional

Summary: 
      In our study, it was aimed to investigate the effect of insoles specially designed for each
      patient and printed with 3D printers on the physical activity levels, balance and functional
      performances of those patients.
    

Detailed description: 
      Our study, B.A.İ.B.Ü. İzzet Baysal Physical Therapy Training and Research Hospital and
      Fizyotermal Corp. It will be carried out as a dual center on individuals between the ages of
      18-45 who apply to our clinic. It will be carried out by selecting 48 people who are suitable
      for the study among the flat-footed patients who applied to the clinics.

      Patients will be evaluated before they start using the insoles, and immediately after using
      it , also after wearing the insoles for 8 weeks.

      Patients will be randomized according to the order of their arrival at the clinic.
    

Intervention name(s): ICB Medical Insoles; ICM Insoles
Intervention type(s): Other; Other
Intervention description(s): After the foot analysis of the participants in the intervention group, special insoles will be designed in a computer program. In these insoles, 3-6 mm medial wedge support, 1-3 mm heel wedge support, 2-4 mm medial longitudinal arch support will be provided. These values will be determined according to the needs of each participant. A single physiotherapist will design all insoles. All drawings will be made by a single physiotherapist. After the design of the insoles is completed, insoles will be produced by transferring them to a Computer Numerical Control (CNC) machine. Ethyl vinyl acetate (EVA), the use of which has been found useful before, will be used as the material in the insoles molds. After processing, 1mm thick fabric will be used for the top coating. All insoles will be produced by the same physiotherapist.; As in the intervention group, insoles will be designed for the participants in the control group, processed by CNC machine and the production will be completed. Only 2mm medial longitudinal arch support will be given to the insoles of the people in this group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Circulating Levels of Irisin in Healthy Young Subjects
Condition: Healthy Subjects
Study type: Observational

Summary: 
      Irisin, a newly discovered myokine induced in exercise, has potential effects in stimulating
      adipose tissue browning, fighting obesity and diabetes. No prior study has reported on the
      role of circulating irisin in healthy individuals in correlation with lean and fat body mass.
      Furthermore, the circadian and seasonal variation of irisin is largely unknown.
    

Detailed description: 
      The main aims of this prospective study will be to investigate: 1) circulating irisin levels
      in healthy, young men and women according to their lean and fat mass; 2) the circadian
      variations of irisin levels; 3) the seasonal variations of irisin levels.
    

Intervention name(s): Boost; Aerobic exercise
Intervention type(s): Dietary Supplement; Other
Intervention description(s): After an overnight fast, blood samples will be obtained before as well as 30 min after standardized mixed meal ingestion; After an overnight fast and rest, blood samples will be obtained before as well as 30 min after aerobic exercise
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants will be healthy volunteers of both sexes recruited from the Greek Military
        Medical School personnel, Thessaloniki, Greece.
      
Biospecimen description: 
      Serum
    
Keywords: irisin; adiponectin; leptin; lean body mass; fat mass
A Study to Evaluate the Effects of Efalizumab on Immune Responses in Subjects With Moderate Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, randomized, placebo-controlled, single blind, parallel group,
      single-center study designed to evaluate immune responses during and after administration of
      12 weekly SC doses of 1.0 mg/kg efalizumab in subjects with moderate plaque psoriasis.
    


Intervention name(s): Raptiva (efalizumab)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Moderate Plaque Psoriasis