bioihbjkbjnl/mcl2 huggingface dataset:
Microbiome Test for the Detection of Colorectal Polyps and Cancer
Condition: Colorectal Neoplasms; Colorectal Cancer
MeSH terms: Neoplasms; Colorectal Neoplasms
Study type: Observational

Summary: 
      The purpose if this study is to measure the sensitivity, specificity and accuracy of the
      Metabiomics Colon Polyp and Colorectal Cancer Assay for the non-invasive detection of colon
      polyps or colorectal cancer.
    

Detailed description: 
      The purpose of this study is to conduct clinical research to investigate the association of
      the gut microbiome with colonic neoplasia. In this study patients will supply samples of
      their gut microbiome prior to scheduled colonoscopy; the relative abundance of microbes from
      those samples will be used to predict the presence or absence of colon polyps or colorectal
      cancer. Microbiome based predictions from blinded samples will be compared with colonoscopy
      and pathology results to quantify the sensitivity, specificity and accuracy (reported as %)
      of the Metabiomics Colon Polyp and Colorectal Cancer Assay for colon polyps. The limited
      sample size is anticipated to be insufficient to quantify sensitivity to colorectal cancer.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients at average risk of developing colorectal cancer, scheduled for colonoscopy.
      
Biospecimen description: 
      gut microbiome samples from stool, rectal and colonic mucosa
    
Keywords: Cancer; Colon Cancer; Colorectal Cancer; Neoplasm; Colorectal Neoplasm; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Colonic Diseases; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases
The Effect of Deep Neuromuscular Block on the Perioperative Stress Response Reduction and Postoperative Recovery Enhancement in Robot-assisted Stomach Cancer Surgery
Condition: Stomach Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      Stress reactions caused by surgical stimuli can cause sympathetic nervous system activation
      and increased stress hormones, such as catecholamines, inflammatory cytokines, and pituitary
      hormones, and insulin resistance. In addition, increased catecholamine levels may exacerbate
      postoperative outcomes, especially delayed wound recovery, increased cardiovascular and
      respiratory complications, and immunosuppression. In particular, it is important to reduce
      the stress response for cancer patients during surgery because they are already
      immunocompromised status and more vulnerable to perioperative stressful situation. However,
      there are insufficient results on the benefits of deep neuromuscular block in these patients,
      although some have reported a reduction of postoperative pain and fewer complications in the
      deep neuromuscular block compared with moderate neuromuscular block. Therefore, the
      investigators aim to investigate the difference in the stress response of patients who
      received conventional moderate neuromuscular block or deep neuromuscular block in
      robot-assisted gastric cancer surgery.
    


Intervention name(s): Deep neuromuscular block with 'rocunium®'; Moderate neuromuscular block with 'rocunium®'
Intervention type(s): Drug; Drug
Intervention description(s): Rocuronium will be maintained in a arm 1) deep neuromuscular block group or arm 2) moderate neuromuscular block group (control group) according to the assignment. The degree of muscle relaxation is determined by 1 to 2 for post-tetanic count (PTC) in deep neuromuscular group.; Rocuronium will be maintained in a arm 1) deep neuromuscular block group or arm 2) moderate neuromuscular block group (control group) according to the assignment. The degree of muscle relaxation is determined by 1 to 2 for train-of-four (TOF) in moderate neuromuscular group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: deep neuromuscular block; robot-assisted surgery; stress response; stomach cancer
Efficacy of Non-animal Chondroitin Sulphate for Overweight Subjects With Knee Ostoarthritis.
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Overweight
Study type: Interventional
Phase: Phase 4

Summary: 
      Knee osteoarthritis (OA) is predicted to become the fourth leading cause of disability
      worldwide by 2020. and is estimated to affect more than 40 million people in Europe and 4
      million people in Italy. OA has multifactorial etiology and obesity is one of the most
      important risk factor for knee Regarding therapy of OA in 2014, the European Society for
      Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) published a
      treatment algorithm for the management of knee OA. In Step 1 of the treatment, it is
      recommended to initiate therapy with chronic symptomatic slow-acting drugs for osteoarthritis
      (SYSADOAs). Among SYSADOAs, the evidence is greatest for the effect of chondroitin sulfate
      (CS).

      Sixty overweight subjects with knee osteoarthritis (OA) were recruited and randomly allocated
      to a group of treatment with 600 mg/d of non-animal Chondroitin sulphate (CS) or to a placebo
      group.

      These measurements were considered:

      Tegner Lysholm Knee Scoring (TLKS), Western Ontario and McMaster Universities Arthritis
      (WOMAC) index and Visual Analogue Scale (VAS) for pain were analyzed at time 0 and at 4 and
      12 weeks. Health-related quality of life by ShortForm36, inflammation by C-Reactive Protein
      (CRP) and Erythrocyte Sedimentation Rate (ESR) were also evaluated, together with a body
      composition assessment performed by DXA.
    


Intervention name(s): Non-Animal Chondroitin Sulphate; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Mythocondro® is an ichthyic-like chondroitin sulfate produced by chemical sulfation of a non-sulfated chondroitin backbone obtained by thermo-acid hydrolysis of the capsular polysaccharide naturally produced by an Escherichia coli strain.; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind randomized placebo controlled study. 90 days of treatment with 600 mg/d of non-animal Chondroitin Sulphate or placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: non-animal chondroitin sulphate; knee osteoarthritis; overweight
Safety and Bioefficacy of Vitamin D2 and Vitamin D3
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      The aim of this study is to investigate the bioavailability of vitamin D2 and D3 as measured
      by the increase of the specific hydroxy forms in serum (25(OH)D2 and 25(OH)D3, respectively,
      and by total 25(OH)D.
    

Detailed description: 
      Study design: Human volunteers will receive supplements containing either vitamin D2 or D3
      for a period of 8 weeks. At baseline, after 4 weeks and after 8 weeks, 25(OH)D2, 25(OH)D3 and
      total 25(OH)D will be measured in serum as the main outcome variables. Additional outcome
      variables are the Ca concentration in serum, PTH concentration in serum, ambulatory blood
      pressure and heart rate, and renin expression in peripheral mononuclear cells.

      Groups/Cohorts Assigned Interventions

        1. Placebo group

        2. Vitamin D2-group Daily treatment with vitamin d2-supplements (containing 2000 IU per
           capsule)

        3. Vitamin D3-group Daily treatment with vitamin d3-supplements (containing 2000 IU per
           capsule)
    

Intervention name(s): cholecalciferol; ergocalciferol; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): cholecalciferol, 2000 IU per day, 8 weeks; vitamin d2, 2000 IU per day for 8 weeks; Placebo
Other intervention name(s): Cholecalciferol, vitamin D3
Intervention MeSH terms: Vitamin D; Cholecalciferol; Ergocalciferols
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: randomized controlled trial; vitamin D; bioavailability
External Stressors Prior to Traumatic Knee Injury in Youth Athletes.
Condition: Traumatic Knee Injury
MeSH terms: Wounds and Injuries; Knee Injuries
Study type: Observational

Summary: 
      The aim of this study is to evaluate different aspects of mental stress aspects and its role
      as a potential risk factor for traumatic knee injury in youth athletes. Approximately 300
      athletes (age 16-19) 50% women) who are involved in high risk sports (soccer, handball and
      floorball) will be included. The athletes will record his/hers traumatic knee injury together
      with information about training regimes and some details on injury mechanism on a web-based
      form. The form also includes questions about mental stressors, such as club exchange, changed
      game system in addition to conflict within and outside the family, etc, prior to injury.

      The present study will contribute new knowledge on levels of muscle function and different
      aspects of mental stress factors that may be related to traumatic knee injury in young
      athletes.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Coaches of approximately 1400 athletes, aged 16-19 years, involved in sports related to
        high risk of knee injury (soccer, handball and floorball), at 70 high schools in Sweden,
        will be contacted and introduced to the study through email. The team coach at each school
        will distribute a web-based form to the athletes during their first, second or third year
        of the high-school period by email or through the school's intra-net system.

        We estimate that approximately 300 youth athletes (50% women) will be included. From the
        included participants, ahtletes with traumatic knee injury will be included for furhter
        analysis.
Safety of Total Daily Doses of Polyethylene Glycol (PEG) 400 Administered Orally to Healthy Male Human Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety and tolerance of 5 mL to 20 mL PEG 400 in multiple rising doses
    


Intervention name(s): PEG 400; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
RCT of Air Insufflation Versus Water Infusion Colonoscopy
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Compared with the conventional (air) method, patients examined by the study (water) method
      have lower pain scores and require less medication but have similar cecal intubation rate and
      willingness to repeat future colonoscopy.
    

Detailed description: 
      Background: A novel water method permitted 52% of patients accepting on-demand sedation to
      complete colonoscopy without medications and significantly increased successful cecal
      intubation from 76% to 97% in patients accepting scheduled unsedated colonoscopy.

      Aim: To perform a randomized controlled trial comparing air insufflation (conventional
      method) vs. water infusion in lieu of air (study method) colonoscopy in minimally sedated
      patients.

      Hypothesis: Compared with the conventional method, patients examined by the study method have
      lower pain scores and require less medication but have similar cecal intubation rate and
      willingness to repeat future colonoscopy.

      Setting: Outpatient colonoscopy in a single VA hospital Methods: After informed consent and
      standard bowel preparation, patients received pre-medications administered as 0.5 increment
      of Fentanyl (25 μg) and 0.5 increment of Versed (1 mg) plus 50 mg Diphenhydramine. The
      conventional and the study method for colonoscopy were implemented as previously described.
      Additional pain medications were administered at the patients' request.

      Outcome measures: Increments of medications, pain scores, cecal intubation and willingness to
      repeat colonoscopy.

      Limitations: Single VA site, older male population
    

Intervention name(s): water infusion colonoscopy
Intervention type(s): Procedure
Intervention description(s): water infusion in lieu of air insufflation for screening colonoscopy
Other intervention name(s): optical colonoscopy, water infusion colonoscopy
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: Colorectal cancer screening; optical colonoscopy; water method; sedation
Strengthening Skills Behavioral Intervention for Adults With Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      The purpose of this study is to examine changes in adaptive functioning, quality of life, and
      prospective memory among adults with ASD (Autism Spectrum Disorder) who complete
      Strengthening Skills, a multi-faceted, behavioral intervention that combines the PEERS Social
      Skills program with cognitive compensation training, mindfulness-based emotional regulation,
      and support group components. Participants and their study partners (e.g., spouse, parent,
      friend) will be randomly assigned to one of three groups: Strengthening Skills, PEERS only,
      or a delayed treatment control group. The Strengthening Skills group will meet weekly for 3
      hours for 16 weeks and will learn strategies for gaining and maintaining independence and
      emotion regulation. Participants will also learn strategies from the PEERS Social Skills
      Program. The PEERS only group will meet weekly for 1.5 hours for 16 weeks and will only learn
      strategies from the PEERS Social Skills Program. The delayed treatment control group will
      participant in data collection at four time points over a 10-month wait period, after which,
      they will be enrolled into the Strengthening Skills Program. Behavioral self-report data will
      be collected and a prospective memory assessment will be conducted before and after
      participation in the 16-week programs. Behavioral self-report data will also be collected at
      remote 3- and 6-month follow-up visits.
    


Intervention name(s): Strengthening Skills Program; PEERS Social Skills Program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The Strengthening Skills Program is a new, multi-component intervention. It includes three components: (1) Forming habits to compensate for the difficulties many adults with ASD have with thinking flexibly, planning, and time management. It will emphasize habit-forming behaviors to compensate for weaknesses in functional skills by training on practical techniques; (2) Content from the PEERS Social Skills program to target social challenges, and (3) strategies derived from Mindfulness Based Stress Reduction to target emotion regulation.; PEERS® is a well-established social communication training program, initially developed for adolescents, and more recently extended to young adults with ASD. Program content will be adapted slightly so as to be appropriate for older adults.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Positron Emission Tomagraphy (PET) Study Following a Single Oral Dose of OPC-34712
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      Determine the degree of striatal D2 receptor occupancy induced by OPC-34712 at differenht
      dose levels in healthy volunteers.
    

Detailed description: 
      Subjects will receive a dose of study medication and will undergo a PET scan at 4 hrs and
      23.5 hours post dose. Subjects will remain in the clinic from Day-1 to Day 7 for PK sample
      collection and safety monitoring. Subjects will return to the clinic on Day 10 for a
      follow-up safety assessment.
    

Intervention name(s): OPC-34712
Intervention type(s): Drug
Intervention description(s): Single oral dose, 0.5 to 25 mg
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy Volunteers; Phase I; Pet Scan
Intestinimonas for Prevention of Type 2 Diabetes Mellitus
Condition: PreDiabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The study aims to assess the effects of a microbiota-based product containing Intestinimonas
      in adults with pre-diabetes. The purpose is to determine the safety and efficacy of the
      microbiota-based product on insulin sensitivity in a target group of prediabetic individuals.
      In particular, the objective is to evaluate whether Intestinimonas is able to improve the
      insulin sensitivity, the response to the oral glucose tolerance test (OGTT) and whether it is
      able to modulate the microbiota composition in the study subjects.
    

Detailed description: 
      The study aims to assess the effects of a microbiota-based product containing Intestinimonas
      in adults with pre-diabetes.

      Intestinimonas is an aerobic microorganism which produces butyrate and interacts with the
      local microbiota in small and large intestine.

      In preclinical studies, it was demonstrated that the insulin sensitivity can be enhanced by
      Intestinimonas and similar microbiota.

      The purpose is to determine the safety and efficacy of the microbiota-based product on
      insulin sensitivity in a target group of prediabetic individuals.

      The study participants will be subjects who are overweight and are at risk of developing Type
      2 diabetes.

      The key objective of this randomized, placebo-controlled study is to evaluate whether
      Intestinimonas is able to improve the insulin sensitivity, to assess the response to the oral
      glucose tolerance test (OGTT) and whether it is able to modulate the microbiota composition
      in the study subjects.

      Furthermore, in a open-label follow-up of 14 weeks the effect of a high-dose of
      Intestinimonas will be compared with the low-dose tested in the initial double-blind
      Randomised Controlled Trial (RCT).
    

Intervention name(s): Intestinimonas-capsules; Placebo-capsules
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Capsules containing microbiota (Intestinimonas); Placebo capsules are identical to the active treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Double-blind, randomized, placebo-controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Prediabetic State; Metabolic Syndrome
Pelvic Floor Activity and Breathing in Women
Condition: Pelvic Floor; Respiration
Study type: Observational

Summary: 
      The pelvic floor and diaphragm work together in many different functions. Two important
      functions are breathing and continence. The pelvic floor muscles have to lift and squeeze to
      maintain continence. Breathing, specifically breathing out, makes the pelvic floor lift. The
      investigators don't know how much the pelvic floor lifts and squeezes during different types
      of breathing out. The purpose of this study is to measure pelvic floor lift and squeeze
      during different types of breathing out.
    

Detailed description: 
      The pelvic floor (PF) activates automatically, both squeezing and lifting, during times of
      increased intra-abdominal pressure for postural stability and continence. Expiration
      additionally produces automatic activation of the PF. No study to date has investigated the
      effects of forced expiration on PF displacement and squeeze pressure. The purpose of this
      study was to investigate the effects of variations in forced expiration effort on PF muscles'
      automatic activation.
    

Intervention name(s): Minimum expiration effort; Moderate expiration effort; Maximum expiration effort
Intervention type(s): Other; Other; Other
Intervention description(s): Subjects perform a forced expiration at minimum effort; Subjects perform a forced expiration at moderate effort; Subjects perform a forced expiration at maximum effort
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Convenience sample from a University student, faculty and staff population.
      
Keywords: Pelvic floor; Rehabilitation; Respiration; Urinary incontinence
Sitting Versus Horizontal Position on Craniotomies
Condition: Craniotomy; Brain Tumor
MeSH terms: Brain Neoplasms
Study type: Observational

Summary: 
      The main objectives of this study are comparison of the incidence of intraoperative air
      embolism and the extent of blood loss in patients undergoing posterior cranial fossa (PCF)
      and pineal region (PR) surgeries in sitting and horizontal position. Additionally, the
      overall treatment outcome, neurological functional outcome, degree of tumor removal, clinical
      course in the postoperative period, and the patient satisfaction will be compared between the
      groups.
    

Detailed description: 
      This was a prospective observational study to assess the effects of patient positioning
      during craniotomies on surgical outcomes. Patients were distributed into 2 major groups based
      on the surgical position: sitting and horizontal. Each group was further divided into
      subgroups based on the type and location of the lesion. To achieve the study goals,
      comparison of the 2 approaches in equivalent patient groups was performed, including
      comparable demographics, diagnoses, topographic location of the lesions, anesthetic
      approaches, and surgical experience.

      The operating surgeons decided patient positioning based on clinical judgment. Type of
      anesthesia was defined by the anesthesiologist in charge of the patient however, it was
      maximally standardized for both sites. All the surgeries were performed by neurosurgeons with
      sufficient experience of sitting craniotomies.
    

Intervention name(s): Surgical position
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing elective craniotomies on posterior cranial fossa or pineal region were
        identified on each site before surgery. Patients were asked to be part of the study
        explaining that no intervention was necessary besides a phone call performed by the
        research team 3 months after their surgery.
      
Keywords: Posterior fossa; Pineal region
Efficacy and Safety of AS012 in Subjects With Non-segmental Vitiligo
Condition: Non-segmental Vitiligo
MeSH terms: Vitiligo
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double blind, placebo-controlled, phase II study. The study will be
      performed as a multicenter, multinational study.
    


Intervention name(s): AS012; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral administration; oral administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment