bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Prebiotic-based Snacks on the Gut Microbiota and Perceived 'Satisfaction'
Condition: Obesity
Study type: Interventional

Summary: 
      To determine the effects of prebiotic 'snacks' on gut health and satisfaction between meals
    

Detailed description: 
      The role of the bacteria that reside in the human gut play in human health and disease is of
      increasing importance. Evidence gathered over recent decades' shows that certain bacteria can
      improve resistance to gut infections, reduce cholesterol levels, synthesise vitamins and
      improve the immune response. The potential to modulate the relative balance of these
      so-called 'beneficial' bacteria has been demonstrated through the use of certain fibre
      sources termed prebiotics. In addition there is interest to understand how snacks containing
      these fibre sources may affect levels of 'satisfaction' between meals. The current study will
      address these issues and lead to a greater understanding of the role that prebiotics may play
      in gut health and overall metabolism.
    

Intervention name(s): Nutriose FB06; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Wheat dextrin soluble fibre
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Prebiotics; Gut health; Satisfaction
Coracoid Tunnel Widening After ACJ Tight Rope Fixation
Condition: Orthopedic Disorder; Orthopedic Devices Associated With Misadventures
MeSH terms: Musculoskeletal Diseases
Study type: Interventional

Summary: 
      studying coracoid tunnel widening after arthroscopic fixation of acute acromioclavicular
      joint (ACJ) dislocation using TightRope system and its correlation with loss of reduction and
      the functional scores.
    

Detailed description: 
      Abstract Purpose: To detect coracoid tunnel widening after arthroscopic fixation of acute
      acromioclavicular joint (ACJ) dislocation using TightRope system and its correlation with
      loss of reduction and the functional scores.

      Methods: From July 2016 to Dec 2018, a prospective study was performed at our hospital.
      Twenty-three patients with acute grade III-V ACJ dislocation were included in the study.
      Arthroscopic double tight-rope repair of the ACJ was performed. Coracoid tunnel widening was
      measured by computed tomography (CT) and coraco-clavicular distance was measured on the x-ray
      immediately post-operative and at 12 months. Constant Shoulder Score, Oxford Shoulder Score,
      Nottingham Clavicle Score and Visual analogue scale were used as outcome measures at 12
      months.

      Level of evidence IV Keywords Acute acromioclavicular joint injury . TightRope . Coracoid
      tunnel dilatation. Loss of reduction.
    

Intervention name(s): arthroscopic fixation of Acute acromioclavicular joint injury using tight rope; Tight rope
Intervention type(s): Procedure; Device
Intervention description(s): arthroscopic fixation of Acute acromioclavicular joint injury using tight rope; Adjustable button device from Arthrex Naples USA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute acromioclavicular joint injury .; TightRope .; Coracoid tunnel dilatation.; Loss of reduction.
Lornoxicam Versus Etoricoxib in Postoperative Pain After Total Knee Arthroplasty
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess efficacy and safety of lornoxicam compared with that
      of etoricoxib after total knee replacement.
    

Detailed description: 
      Total primary knee arthroplasty (TKA) remains a model of severe pain for major orthopedic
      surgery. The concept of multimodal analgesia for the postoperative pain therapy is a routine
      in many hospitals but the question is still under debate about the ideal combination between
      techniques and drugs regarding early mobilization and low risk of complications.

      After obtaining Ethical Committee approval and informed consent, 110 patients American
      Society of Anesthesiologists score (ASA ) I-II undergoing knee replacement under spinal
      anesthesia were randomized to receive postoperative either lornoxicam (8 mg per os (PO) /12
      hours (h) for 48 h) or etoricoxib (120mg PO/24 h for 48 h) both administered in the
      postoperative care unit, at the end of surgery.

      The groups received postoperative analgesia when Numeric Rating Scale (NRS) over 3 with IV
      Perfalgan in fixed dose 1g every 8 h and morphine (loading dose 0,1mg/kg and titration until
      NRS under 3, followed by subcutaneous (SC) administration of ½ of the total loading dose on
      demand for the following 48 h).The lornoxicam group received gastric protection with IV
      pantoprazole.

      The effectiveness was evaluated by the time from the initiation of spinal anesthesia until
      the first analgesic dose at NRS over 3, the total amount of morphine in the first 24 and 48 h
      postoperative, the side effects and necessary amount of adjuvant medication.
    

Intervention name(s): Lornoxicam; Etoricoxib
Intervention type(s): Drug; Drug
Intervention description(s): At the end of surgery patients in group LORNOXICAM received one pill of 8 mg lornoxicam every 12 hours in the surgery day and first postoperative day.; At the end of surgery patients in the ETORICOXIB group received one pill of 120 mg etoricoxib at the end of surgery and a second one after 24 hours. This group also received placebo pills at 12 h, between the active pills.
Other intervention name(s): XEFO RAPID; XEFO; Arcoxia; Tauxib
Intervention MeSH terms: Etoricoxib; Lornoxicam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: postoperative pain; lornoxicam; etoricoxib; total knee arthroplasty
Gene Polymorphisms in Tacrolimus Drug Interactions
Condition: Renal Transplantation
Study type: Observational

Summary: 
      A retrospective analysis of the influence of gene polymorphisms on drug interactions between
      calcineurin-inhibitors and concomitant drugs in renal transplant patients.
    


Intervention name(s): genotyping
Intervention type(s): Other
Intervention description(s): Restriction fragment lenght polymorphisms
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Renal transplant recipients treated with a calcineurin-inhibitor
      
Biospecimen description: 
      DNA samples
    
Keywords: Tacrolimus; Renal Transplantation; genetic polymorphisms; Drug drug interactions
Intake of Omega 3 in Morbidly Obese Patients
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      Ingestion of capsules of omega 3 EPA and DHA, with 1.8 g of EPA and 1.2 g DHA for morbidly
      obese patients, will improve the inflammatory status? C-reactive protein? Weight?
    

Detailed description: 
      Intake of EPA and DHA for the management of morbid obesity in capsules

      - Reduction of inflammatory factors such as adipokines, glucose, C-reactive protein,
      cholesterol, weight, BMI. Will be 2 groups: cases and controls. The cases will intake of
      omega 3 capsules and placebo control.
    

Intervention name(s): Omega 3 intake, morbid obesity; Placebo Capsules
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Individuals of both sexes with ages between 18 and 65 years took 3g of omega 3, and 1.8g eicosapentaenoic acid (EPA) and 1.2g docosahexanoic acid (DHA) for 8 weeks.; They received gelatin (colorless) capsules. A nutritional evaluation was performed, a 24-h recordatory was applied to verify macro and micronutrients intake, biochemical evaluation before and after the intervention. Macro and micronutrients were calculated using the Avanutri 2.0 system. Clinical history was verified through a questionnaire previously filled out by a physician.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: morbid obesity; BMI at or above 4O kg/m2; ingestion of omega 3; inflammatory cytokines; biochemical factors; anthropometric factors
Choose the Best Concentration of Ropivacaine on TAP Block for Open Appendectomy in Children
Condition: Pain, Postoperative; Appendicitis
MeSH terms: Appendicitis; Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Blockage of the transverse abdomen (TAP) promotes excellent analgesia of the abdominal wall
      and the parietal peritoneum. The TAP block could advange the postoperative pain of
      Appendectomy in children. The world literature doesn´t focus the best Ropivacaine´s
      concentration to improve postoperative pain in Appendectomy in children. We propose a
      randomized trial that compares 3 groups children submitted Appendectomy in children between 6
      and 16 years. The control group has received no blockade, the other two groups have received
      TAP blocks if ropivacaine 0,25% and 0,5% 0.4ml/kg.
    

Detailed description: 
      Blockage of the transverse abdomen (TAP) promotes excellent analgesia of the abdominal wall
      and the parietal peritoneum. The meta-analyzes in adults demonstrate improved of
      postoperative pain and analgesic´s consumption. There are few studies on TAP block in open
      appendectomies and laparoscopic in pediatrics, they show good results. There is a consensus
      of the best anesthetic volume for good infiltration of the TAP block, but there are still
      doubts in the literature about the best concentration of local anesthetics of long duration.
      The main objective of this prospective, randomly distributed and double-blind clinical trial
      is to evaluate two concentrations of 0.25% and 0.5% ropivacaine with a volume of 0.4 ml / kg
      in pain control and the analgesic consumption through 24 hours observation in open
      Appendectomy in children between 6 and 16 years. 3 groups were being compared: the control
      group has received no blockade, the other two groups have received TAP blocks if ropivacaine
      0,25% and 0,5% 0.4ml/kg. All pacients patients received the same protocols (anesthesia and
      analgesia). The provided analgesia was dipyrone every 6 hours and ketoprofen every 8 hours,
      and rescue analgesia was tramadol every 4hours if it were required. The FACE pain scale was
      used to evaluate the postoperative pain.
    

Intervention name(s): Ropivacaine
Intervention type(s): Drug
Intervention description(s): Surgery for appendicitis
Other intervention name(s): Appendectomy
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: appendectomy, pediatrics, nerve block, abdominal wall
Endostar Combined With Chemotherapy for Stage Ⅳ Soft Tissue Sarcoma
Condition: Soft Tissue Sarcoma, Adult, Stage IIB
MeSH terms: Sarcoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled (2: 1), multicenter clinical phase II
      clinical trial evaluating the efficacy and safety of Endostar combined with chemotherapy for
      stage IV soft tissue sarcoma.
    

Detailed description: 
      The prognosis of sarcoma patients in stage IV is poor. For STS, the response rate of
      chemotherapy is only 20-35% and the median survival time is about 12 months. The 5 year
      survival rate is lower than 10% reported in several large-scale studies. Although
      chemotherapy plays a major role in the treatment of advanced STS, the classic chemotherapy
      agents are not curative. Combination chemotherapy or dose-dense regimens have largely failed
      to improve the response rates. Long-term using of cytotoxic drugs increased the risk of
      toxicity in patients. Endostatin is the strongest endogenous angiogenesis inhibitor, which
      inhibits vascular endothelial growth factor (VEGF) expression and then inhibits tumor
      angiogenesis . Endostar, is a novel recombinant human endostatin, with advantages of long
      half-life, stable and low cost. Recently, a study of Endostar combined with chemotherapy in
      the treatment of advanced soft tissue sarcoma indicated resulted in a higher clinical benefit
      response (CBR) and longer progression-free survival (PFS), with tolerable side effects.
      However this study included the patients with stage IIB-IV soft tissue sarcomas and did not
      include specific pathologic information. Thus this clinical trial is designed to compare the
      efficacy and safety of endostar combined with chemotherapy versus chemotherapy alone in stage
      IV patients with soft tissue sarcomas.
    

Intervention name(s): Endostar; Placebo; AIM regimen / GT regimen
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Recombinant Human Endostatin Injection; 500ml 0.9% sodium chloride; "Pirarubicin (THP) + Ifosfamide (IFO)" / "Docetaxel (TXT) + Gemcitabine (GEM)"
Other intervention name(s): Recombinant Human Endostatin Injection; Placebo(for Endostar)
Intervention MeSH terms: Endostar protein; Endostatins
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: A total of 150 cases, according to 2: 1 random into the group. Among them, 100 cases of Endostar combined chemotherapy group, 50 cases of placebo + chemotherapy group.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Endostar; Soft Tissue Sarcoma; Chemotherapy
Glycemic Variability in Intermittent Fasting
Condition: Intermittent Fasting
Study type: Interventional

Summary: 
      The aim was to test the difference in glycemic variability after meal consumption during
      intermittent fasting and the usual diet.
    

Detailed description: 
      Healthy participants were recruited for this crossover study aiming to determine the
      difference in glycemic variability after meal consumption while practicing intermittent
      fasting and the usual diet. Prior to the protocol assignment, participants were followed for
      3 days - they were instructed to maintain their usual sleep pattern, level of physical
      activity and diet. Control of dietary pattern was conducted by using the 3-day food diary.
      Day zero was preparation day for the protocol (Intermittent fasting or Control diet) when all
      participants received individualized 3-day diet plan. Each protocol lasted 3 days with a
      7-day washout period. Each protocol consisted of 3 meals per day, each providing a third of
      the total energy requirement. Control diet protocol was set at 12 hours eating/12 hours
      fasting, and Intermittent fasting protocol 6 hours eating/18 hours fasting. Blood glucose was
      measured at zero, 15, 30, 45 and 90 minutes after meal consumption. Before breakfast, blood
      glucose was measured also at minus 5 minutes prior meal consumption.
    

Intervention name(s): Intermittent Fasting; Control Diet
Intervention type(s): Other; Other
Intervention description(s): Participants received a 3-day individualized diet plan consisting of 3 meals per day. Meals needed to be consumed during 6 hours (while fasting for the remaining 18 hours). Diet plans were matched for energy and macronutrients.; Participants received a 3-day individualized diet plan consisting of 3 meals per day. Meals needed to be consumed during 12 hours (while fasting for the remaining 12 hours). Diet plans were matched for energy and macronutrients.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Blood Glucose; Glycemic variability; Intermittent fasting; Crossover Intervention
Study of the Effectiveness of Vestibular Stimulation as a Coadjuvant Treatment in Major Depression
Condition: Depression; Major Depression; Vestibular Disorders
MeSH terms: Vestibular Diseases; Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Major depression is characterized by vestibular anomalies. The investigators hypothesized
      that vestibular stimulation will improve depression symptoms in major depression patients.
    


Intervention name(s): vestibular stimulation
Intervention type(s): Other
Intervention description(s): vestibular stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: depression; vestibular
A Trial of INS068 in Patients With Type 2 Diabetes Not Adequately Controlled With One or Two Oral Antidiabetics
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is being conducted to evaluate the efficacy and safety of IND068 once daily (QD) in
      subjects with type 2 diabetes not adequately controlled with one or two oral antidiabetics
      compared to insulin degludec QD for 16 weeks.
    


Intervention name(s): INS068 injection; Insulin Degludec
Intervention type(s): Drug; Drug
Intervention description(s): INS068 injected subcutaneously once daily. Treat-to-target dose titration during the trial; Insulin Degludec injected subcutaneously once daily. Treat-to-target dose titration during the trial
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: INS068 campared with Insulin degludec, both in Combination with One or Two Oral Antidiabetics
Masking: None (Open Label)
Primary purpose: Treatment
Cognitive-Behavioral Bibliotherapy for the Treatment of Obsessive Compulsive Disorder in Children and Adolescents
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      This 16-week program examines cognitive behavioral bibliotherapy to typical
      therapist-directed cognitive behavior therapy for children and adolescents with Obsessive
      Compulsive Disorder.
    

Detailed description: 
      This study is designed to compare self-directed bibliotherapy and therapist-directed
      cognitive behavioral therapy for children and adolescents with Obsessive Compulsive Disorder
      (OCD). Both treatments involve exposure and response prevention (EX/RP), in which the child
      confronts OCD fears and is asked to refrain from compulsive rituals (such as repetitive
      handwashing, counting, etc.). Participants are requested to complete an initial evaluation to
      determine diagnosis, and four follow-up evaluations to assess symptom severity and change due
      to treatment for a total of 16 weeks. Participant involvement to self-directed bibliotherapy
      versus traditional cognitive-behavioral treatment will be determined through random
      assignment.

      In the bibliotherapy condition, the child or adolescent will meet with a therapist twice over
      the course of treatment, along with a parent. The therapist will discuss a self-directed
      program of EX/RP to be implemented at a pace deemed appropriate by child and parent at their
      own home. The child and parent will be provided with a manual designed to instruct them how
      to cope with Obsessive Compulsive Disorder. This treatment involves the parent and child
      reading the book, performing exercises, and monitoring symptoms on a weekly basis for 8
      weeks.

      In the therapist-directed treatment condition, the child or adolescent will meet weekly with
      a therapist along with their parent. The therapist, parent, and child will work together to
      design and implement a program of EX/RP. This treatment involves performing exercises,
      monitoring symptoms on a weekly basis, and completing homework assignments. Parents will be
      asked to help coach their child with at-home exercises challenging the Obsessive Compulsive
      Disorder. This treatment lasts 12 weeks.

      Evaluations will be conducted following the completion of each treatment to assess the
      efficacy of each treatment on OCD symptoms. The treatment and evaluations for OCD are
      provided free of charge.
    

Intervention name(s): Cognitive Behavioral Bibliotherapy; Cognitive Behavioral Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Minimal therapist direction for self-guided bibliotherapy involving exposure and response prevention; Therapist-directed exposure and response prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Open-Label, Single and Multiple Dose Pharmacokinetic Study of 90 mg and 180 mg Doses of AZD6140 in Healthy Volunteers
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a single centre study conducted at the 3rd hospital affiliated to Peking
      University. Approximately 24 healthy Chinese volunteers, male and female, will be recruited
      to obtain at least 20 evaluable volunteers. The primary objective of this study is to
      characterize the pharmacokinetics of AZD6140 and its active metabolite AR-C124910XX after
      single and multiple (twice daily) doses of AZD6140 90 mg and 180 mg in healthy Chinese
      volunteers. The secondary objective of this study is to determine the safety and tolerability
      of single and multiple (twice daily) 90 mg and 180 mg doses of AZD6140 by physical
      examination, clinical laboratory tests, vital signs, and collection of adverse events in
      healthy Chinese volunteers.
    


Intervention name(s): AZD6140; AZD6140
Intervention type(s): Drug; Drug
Intervention description(s): 90mg tablet, oral, once daily for the first day and twice daily from day 4 to 9; 90 x 2 mg tablets, oral, once daily for the first day and twice daily from day 4 to 9
Intervention MeSH terms: Ticagrelor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics
Central Corneal Thickness in Glaucoma
Condition: Exfoliation Syndrome
MeSH terms: Glaucoma; Exfoliation Syndrome; Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to compare the central corneal thickness measurement in patients
      with exfoliation syndrome, exfoliative glaucoma, primary open-angle glaucoma, ocular
      hypertension and normal controls and to evaluate the value of corneal thickness in the
      diagnosis and management of glaucoma.
    

Detailed description: 
      To compare the central corneal thickness measurement in patients with exfoliation, primary
      open-angle glaucoma, ocular hypertension and normal controls and to evaluate the value of
      corneal thickness in the diagnosis and management of glaucoma. Prospective study in progress.
      Randomly selected patients undergo a comprehensive ophthalmic exam which includes 2 separate
      pachymetry measurements in 2 different examinations at the same time of the day (10:00 am)
      with 3 different pachymeters. The values obtained are correlated with a number of other
      glaucoma parameters. A thinner cornea may represent a specific attribute and an additional
      risk factor for patients with exfoliation. Evaluation of corneal thickness is an important
      exam in the management of patients with exfoliation.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        individuals with and without exfoliation
      
Keywords: corneal thickness; exfoliation