bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Intestinal Virome on Pediatric Inflammatory Bowel Disease
Condition: Inflammatory Bowel Diseases
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Observational

Summary: 
      Over the last few years, dysbiosis has emerged as a possible trigger of gut inflammation in
      inflammatory bowel disease (IBD) and a promising therapeutic target. The complex diversity of
      microbiota was initially highlighted by the powerful new tools in genetics, including
      next-generation sequencing (NGS). NGS permitted to decipher the composition of bacterial
      intestinal communities, but also that of the gut virome. Since then, the evidence of a
      dynamic instability of the enteric virome in IBD has grown considerably. IBD patients present
      an expansion of bacteriophages (Caudovirales) associated with decreased bacterial diversity.
      Moreover, gut virome richness seems to differ between Crohn's disease (CD) and ulcerative
      colitis (UC) patients. These insights open the gate of new diagnostic, predictive, and
      therapeutic approaches. However, little is known about pediatric IBD gut virome in terms of
      variability and evolution under the influence of different treatments (exclusive enteral
      nutrition, immunosuppressive therapy and biologics). The aim of this study is to evaluate the
      gut family viral diversity and relative abundance of eukaryotes and prokaryotes in paediatric
      IBD patients
    


Intervention name(s): Collection of stool and blood samples
Intervention type(s): Other
Intervention description(s): For each visit, stool and blood samples will be collected during a pediatric gastroenterology day hospital stay.
This collection of stool and blood specific IVOIRE study is carried out in the context of examination already planned for the usual care of the patient.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with nflammatory bowel disease newly treated with anti-TNF therapy in the "Hôpital
        Femme Mère Enfant" center in Lyon
      
Biospecimen description: 
      Stool and blood samples from paediatric inflammatory bowel disease patients.
Administration of Pre-Operative Gabapentin to Patients Undergoing Laparoscopy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to prospectively determine the influence of immediate
      pre-operative gabapentin administration on acute postoperative pain. The investigators
      hypothesize that immediate post-operative pain will be improved with pre-operative
      administration of gabapentin.
    

Detailed description: 
      The purpose of this study is to prospectively determine the influence of immediate
      pre-operative gabapentin administration on acute postoperative pain. We hypothesize that
      immediate post-operative pain will be improved with pre-operative administration of
      gabapentin.

      We plan to conduct a prospective randomized trial to assess the effect of a single immediate
      pre-operative dose of gabapentin 300mg on immediate post-operative pain in patients
      undergoing laparoscopy for gynecologic indications. This concept has been studied in patients
      undergoing abdominal hysterectomy. We aim to study the effect on patients undergoing
      laparoscopy.
    

Intervention name(s): Gabapentin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.; Patient will receive placebo tab less than 1 hour before surgery
Other intervention name(s): Neurontin; 78309289
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: laparoscopy; postoperative pain; gynecology; gabapentin
Seroquel STACK Study in Schizophrenic or Schizoaffective Subjects
Condition: Schizophrenia; Schizoaffective Disorders
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess and compare the side effect profile, safety,
      tolerability and efficacy of schizophrenic or schizoaffective subjects non- or partially-
      responsive to 800 mg/day of quetiapine treated with either 800 mg/day or more than 800 mg/day
      of quetiapine during 8 weeks.
    


Intervention name(s): Quetiapine
Intervention type(s): Drug
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: schizophrenia; schizoaffective disorders
The Effect of MTA and PRF Application in Periapical Lesions
Condition: Apical Periodontitis; Wound Heal
MeSH terms: Periodontitis; Periapical Periodontitis
Study type: Interventional

Summary: 
      A total of 40 periapical lesions from the 33 patient undergoing apical surgery were randomly
      selected from December 2016-November 2017. Patients were informed about the surgical
      procedure and signed a consent form. Groups were divided in to 4; as control, MTA (mineral
      trioxide aggregate), PRF (platelet rich fibrin) and MTA+PRF groups. Apical resection was
      performed in all groups. No other interventions were made to the control group.

      Routine radiographs were taken in the 1st. 3th and 6th months. In the (approximately) 12th
      month of the procedures computerized tomography scans were taken. Primary healing of the
      periapical tissues were evaluated and the outcomes were measured. Patients have still been
      under control for the long term outcomes of the study.
    

Detailed description: 
      44 apically infected periapical lesions were decided to enroll to the study from December
      2016-November 2017. However; a total of 40 periapical lesions undergoing apical surgery were
      recruited for the planned clinical trial in the end. The study was conducted under randomized
      controlled protocol. Patients were informed about the surgical procedures and signed a
      consent form. The anticipated outcomes, possible risks and benefits of the study as well as
      the alternative treatment options were explained to the patients.

      Groups were designed to have 10 patients in each and randomly divided into four as; control,
      MTA, PRF and MTA+PRF. Apical resection was performed in all groups. No other interventions
      were made to the control group.

      Routine radiographs were taken in the 1st. 3th and 6th months. In the 12th month of the
      procedures computerized tomography (CT) scans were taken. Primary healing of the periapical
      tissues were evaluated according to the volumes and the densities of the lesions. Outcomes
      were measured. Comparison between the initial and the last 3D CT scan volumes were made by
      medical image processing software (MIMICS, Belgium). Patients have still been under control
      for the long term outcomes of the study.
    

Intervention name(s): control group; MTA group; PRF group; MTA + PRF group
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): a procedure used to prevent or resolves apical periodontitis.; a procedure used to prevent or resolves apical periodontitis.; a procedure that is used for wound healing; a procedure used to prevent or resolves apical periodontitis in combination with a procedure that is used for wound healing.
Other intervention name(s): root resection; mineral trioxide aggregate; platelet rich fibrin; mineral trioxide aggregate + mineral trioxide aggregate
Intervention MeSH terms: Pemetrexed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Single Ascending Dose Study of TD-1439 in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of TD-1439 in healthy subjects
    


Intervention name(s): TD-1439; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Single ascending dose
Study to Evaluate the Effect of a Very Low Carbohydrate Diet on Gastroesophageal Reflux Disease
Condition: Gastroesophageal Reflux Disease; Overweight; Acid Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic; Overweight
Study type: Interventional

Summary: 
      The purpose of this research study is to learn if a very low carbohydrate (sugar) diet or
      traditional low fat diet is able to reduce symptoms related to gastroesophageal reflux
      disease (GERD) in people who are overweight. Patients with GERD may experience all or some of
      the following symptoms: stomach acid or partially digested food re-entering the esophagus
      (which is sometimes referred to as heartburn or regurgitation) and belching. In this study,
      the investigators also hope to find out if acid in the esophagus is reduced more by a low
      carbohydrate diet than a low fat diet.
    


Intervention name(s): Diet - very low carb or low fat
Intervention type(s): Other
Intervention description(s): Diet comparison in Gastroesophageal Reflux Disease
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: low carbohydrate; low fat; diet; overweight; GERD; gastroesophageal reflux disease; acid reflux; heartburn
THE EFFECT OF MULTIPLE DOSES OF PF-06835919 ON THE PHARMACOKINETICS OF A SINGLE ORAL MIDAZOLAM DOSE IN HEALTHY PARTICIPANTS
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, open label, 2 way crossover drug drug interaction (DDI) study
      which will evaluate the impact of PF 06835919 on midazolam pharmacokinetics in healthy
      participants. Participants will be randomized to 1 of 2 treatment sequences as described
      below. A total of approximately 10 healthy male and/or female participants will be enrolled
      in this study so that approximately 5 participants will be enrolled into each treatment
      sequence. In this crossover study, 2 treatments are being assessed.
    


Intervention name(s): PF 06835919; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): 300 mg; 7.5 mg
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficacy and Safety of MW031 in PMO Subjects
Condition: Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a multicenter, randomized, double-blinded, placebo-controlled Phase III
      clinical study to evaluate the clinical efficacy and safety of MW031 in Chinese
      postmenopausal osteoporotic subjects with increased bone fracture risk .
    


Intervention name(s): MW031; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The active ingredient of MW031 is a recombinant human anti-RANKL monoclonal antibody ,subcutaneous injection of 60 mg (1.0 mL)every 6 months for a maximum of 2 consecutive doses throughout the trial.
Dietary Supplement: Elemental Calcium Oral, at least1000 mg Dietary Supplement: Vitamin D Oral, 400 IU; subcutaneous injection of 60 mg (1.0 mL)every 6 months for a maximum of 2 consecutive doses throughout the trial.
Dietary Supplement: Elemental Calcium Oral, at least1000 mg Dietary Supplement: Vitamin D Oral, 400 IU
Other intervention name(s): Recombinant anti-RANKL human monoclonal antibody injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Alanine in Patients With Nonalcoholic Steatohepatitis
Condition: Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      Purpose of this study is to assess the therapeutic efficacy of L-alanine in improving
      biological and histological findings by administrating 6-18g/day L-alanine for one year. We
      will also assess the safety and toxicity profile of long-term administration of L-alanine.
    


Intervention name(s): L-alanine
Intervention type(s): Drug
Intervention description(s): 6g of L-alanine (powder)once per day for the first month, twice per day for the second month, then three times per day from the third month for 10 months.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nonalcoholic Steatohepatitis; NASH; L-Alanine
Phase IV Interchangeability Study of a Liquid Pentavalent Combination Vaccine
Condition: Diphtheria; Tetanus; Pertussis; Hepatitis B; Haemophilus Influenzae Type B
MeSH terms: Hepatitis A; Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Hepatitis; Tetany
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to compare the Safety and Immunogenicity of a mixed sequence
      of 2 different pentavalent vaccines (Diphtheria-Tetanus- Pertussis, Hepatitis B and Hib
      combination Vaccines) with single sequence of Shan 5 in infants.
    


Intervention name(s): Shan 5; Easy Five
Intervention type(s): Biological; Biological
Intervention description(s): Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine; Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib conjugate pentavalent liquid combination vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Vaccine; Prevention; Diphtheria; Tetanus; Pertussis; Hepatitis B; Haemophilus influenzae type b; Vaccine interchangeability; Single vs mixed sequence; Healthy infants
Efficacy Study of a Bioelectric Dressing Used With Negative Pressure Wound Therapy to Treat Diabetic and Pressure Ulcers
Condition: Wound Healing
MeSH terms: Pressure Ulcer; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether a bioelectric wound dressing, used in
      conjunction with Negative Pressure Wound Therapy (NPWT), is effective in the treatment of
      diabetic and pressure ulcers of the foot.
    


Intervention name(s): Procellera™ Wound Dressing with V.A.C.® Therapy; V.A.C.® Therapy
Intervention type(s): Device; Device
Intervention description(s): Dressing indicated for partial and full-thickness wounds. Weekly dressing changes, more frequently if needed. Used as a primary contact layer in conjunction with NPWT.; Vacuum Assisted Closure device that uses controlled negative pressure, with dressing changes 1x/week.
Other intervention name(s): PROCELLERA™, PROSIT™, Bioelectric; Negative Pressure Wound Therapy, Vacuum Assisted Closure, V.A.C.® Therapy,
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Wound; Skin lesion; Antimicrobial; Bioelectric; Diabetic foot; Pressure Ulcer
Study Of Single Dose Of ATN-103 Administered To Healthy Japanese Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety and tolerability of ascending single SC and IV doses of ATN-103 in
      healthy Japanese male subjects.
    


Intervention name(s): ATN-103; ATN-103; ATN-103; ATN-103; ATN-103; ATN-103; ATN-103; ATN-103; ATN-103
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1.5 mg solution, single subcutaneous injection; 4 mg solution, single subcutaneous injection; 10 mg solution, single subcutaneous injection; 25 mg solution, single subcutaneous injection; 25 mg solution, single intravenous injection; 50 mg solution, single subcutaneous injection; 100 mg solution, single subcutaneous injection; 200 mg solution, single subcutaneous injection; 200 mg solution, single intravenous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: healthy subjects
Impulsivity and Stimulant Administration
Condition: Cocaine Dependence; Impulsivity
MeSH terms: Cocaine-Related Disorders; Impulsive Behavior
Study type: Interventional
Phase: Phase 1

Summary: 
      Examine the interaction between stimulants, such as cocaine and methylphenidate, and
      impulsivity.
    


Intervention name(s): cocaine hydrochloride; methylphenidate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cocaine; Methylphenidate
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Are There Different Objective Fixation Disparity Values for Two Different Test Paradigms
Condition: Vision Disparity
Study type: Observational

Summary: 
      In optometry, binocular coordination is measured subjectively. The result is subjective
      fixation disparity. In research different experiments have proven, that subjective and
      objective fixation disparity are different. A binocular eyetracker has to be calibrated.
      There are two well known calibration methods: associated and dissociated calibration.
      Objective fixation disparity is measured in arcMin. Therefore, the precision of the
      eyetracker plays a crucial role. Now, the investigators try to compare dissociated
      calibration with polarized filters and associated calibration under different test paradigms.
    


Intervention name(s): different test paradigms
Intervention type(s): Other
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adults without binocular problems
Ischemic Conditioning Chronic Stroke Study
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Stroke is the leading cause of disability in adults in the United States. Despite advances in
      hyperacute stroke care, advancements in stroke rehabilitation are lagging. We have previously
      shown that a non-invasive, cost-effective, easy to perform intervention, called ischemic
      conditioning (IC), can improve paretic leg strength, reduce muscle fatigue, and increase
      walking speed in chronic stroke survivors (>1 year post-stroke). The IC procedure makes the
      paretic leg transiently ischemic (5 minutes) using a cuff inflated to 225 mmHg, and repeats
      the occlusion 5 times with 5 minute periods of rest between cycles (45 total minutes). It is
      well accepted that the response to IC is complex and involves local, humoral and neural
      factors. The mechanism by which IC can confer motor benefit in stroke survivors is unknown.
      The aim of this study is to examine if IC can increase sympathetic nervous system (SNS)
      activity, which would promote an increased cardiovascular response to exercise and increased
      muscle strength. We hypothesize that plasma epinephrine and norepinephrine levels will
      increase more during a cold pressor test (a well-tolerated test to induce a sympathetic
      response) in chronic stroke survivors who undergo a single session of IC vs. IC-Sham. To
      accomplish the goals of this study, 15 chronic stroke survivors will each make two visits to
      the adult translational research unit at Medical College of Wisconsin (MCW) to have either IC
      or IC-Sham performed on their paretic leg in a counterbalanced order. Venous blood will be
      drawn before and after the IC or IC-Sham procedure and after a two-minute cold pressor test
      where the study participants submerge their hand into a bucket of ice water. This will cause
      an increased sympathetic response, which will be assessed by measuring blood pressure and the
      relative increase in the levels of circulating catecholamines (epinephrine and
      norepinephrine, assessed by high performance liquid chromatography).
    


Intervention name(s): Ischemic Conditioning; Sham Ischemic Conditioning
Intervention type(s): Procedure; Procedure
Intervention description(s): Ischemic conditioning is a well-defined, non-invasive procedure which consists of inflating a blood pressure cuff around a limb (in our study, the paretic leg), inflating the cuff to 225 mmHg to occlude blood flow to the limb for 5 minutes, releasing the cuff for 5 minutes, and repeating 5 times. In our study, participants will receive one session of the intervention (45 minutes total).; There will also be an IC Sham group which is identical to the IC intervention, except the cuff is only inflated to 10 mmHg, which is a high enough pressure to perceive cuff tightness but not high enough to have any physiological effects.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Use of Laser Assisted New Attachment Procedure and Low Level Laser Therapy for Periodontitis Patients
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      In this study, it is evaluated the effects of laser assisted new attachment procedure (LANAP)
      and low level laser therapy (LLLT) and on clinical, biochemical and radiographic parameters
      in addition to non-surgical periodontal treatment (NSPT).
    

Detailed description: 
      The study was designed as a randomized-controlled, single-blind and parallel design
      consisting of 80 patients with chronic periodontitis. Study consists of 4 groups, with 20
      patients in each group. Group 1 received only NSPT, Group 2 received NSPT+LANAP, Group 3
      received NSPT+LLLT, and Group 4 received NSPT+LANAP+LLLT. Clinical measurements of patients
      and gingival crevicular fluid (GCF) were taken before treatment and after 1 and 3 months. In
      GCF, interleukin-1beta, interleukin-10 and vascular endothelial growth factor were analyzed.
      Standard periapical radiographs were taken for radiographic measurements.

      In moderate (4-6 mm) and deep pockets (7 mm and above), it was found that all groups treated
      with laser significantly decrease pocket depth (PD) and clinic attachment level (CAL)
      compared to Group 1. Group 3 caused significantly less gingival recession than all other
      groups. There was no statistical difference between the groups in biochemical markers.
      Radiographic analysis revealed that only Group 2 achieved significant bone filling compared
      to Group 1.

      Bot LANAP and LLLT application in the deep pockets provide an additional contribution to
      NSPT. It has been found that LLLT administration leads to decrease in PD by creating a
      minimum recession.
    

Intervention name(s): Nd:YAG laser
Intervention type(s): Device
Intervention description(s): For LANAP, the fiber optic tip of the Nd:YAG laser (1064 nm) (Fotona Fidelis AT, USA) was used. For LLLT R24 biostimulation handpiece tip (950-μm) Nd:YAG laser (1064 nm) was used.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: single-blind randomized controlled clinical study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Laser Assisted New Attachment Procedure; Low Level Laser Therapy; periodontitis; non-surgical periodontal therapy