bioihbjkbjnl/mcl2 huggingface dataset:
Allogeneic Bone-patellar Tendon-bone Transplantation
Condition: Anterior Cruciate Ligament Rupture
MeSH terms: Rupture
Study type: Interventional

Summary: 
      Objective To investigate the mid-term clinical effect of bone-patellar tendon-bone (BPTB)
      graft double-bundle reconstruction of the anterior cruciate ligament (ACL) of the knee joint
      under arthroscope.
    

Detailed description: 
      The purpose of the present study was to report a unique technique of Double-bundle anterior
      cruciate ligament reconstruction (DB-ACLR) with a bone-patellar tendon- bone (BPTB)
      allograftand compare the clinical outcome of the new technique with that of the nonanatomic
      conventional transtibial Single-bundle anterior cruciate ligament reconstruction (SB-ACLR)
      with a BPTB allograft. The hypothesis was that the DB-ACLR with a BPTB allograft is
      technically feasible and may be superior in restoring anterior and rotational stability of
      the knee joint. Meanwhile, the back-pushing KT- 2000 arthrometer was used to confirm whether
      there were advantages of DB-ACLR in total anteroposterior stability.
    

Intervention name(s): BPTB double-bundle allograft; BPTB single-bundle allograft group; BPTB single-bundle autograft group
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): The patient underwent surgery of arthroscopic double-bundle anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone (BPTB) allograft．; The patient underwent surgery of arthroscopic single-bundle anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone (BPTB) allograft．; The patient underwent surgery of arthroscopic single-bundle anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone (BPTB) autograft．
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Effect of Subcutaneous Tissue Closure on Wound Complications
Condition: Cesarean Section
Study type: Interventional

Summary: 
      Only a small number of research studies evaluated the impact of various subcutaneous tissue
      and skin closure methods at cesarean section. In a meta-analysis a major decline in incision
      site rupture was revealed when suturing the subcutaneous tissue in women with a subcutaneous
      depth >2 cm.
    

Detailed description: 
      Postoperative wound complications are one of the great issues in cesarean section (CS) with
      an incidence ranging from 3% to 30%.1 Obesity, operative time, diabetes, age of the patient,
      anemia, associated infection (e.g chorioamnionitis), the use of internal monitoring, delayed
      labor with many vaginal examinations and reduced nutrition are recognized risk factors for
      wound infections.

      Evaluating the various techniques for closure of the subcutaneous layer.
    

Intervention name(s): interrupted sutures; continous sutures
Intervention type(s): Procedure; Procedure
Intervention description(s): The way of closing subcutaneous tissue either by interrupted; The way of closure of subcutanous tissue is by continous sutures
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Cesarean section; Wound infection; Gapping
Fluid Resuscitation for Pediatric Diabetic Ketoacidosis
Condition: Diabetes
MeSH terms: Ketosis; Diabetic Ketoacidosis
Study type: Interventional

Summary: 
      Randomized trial to determine if the volume of fluid administration in pediatric patients
      with DKA impacts the rate of normalization of serum bicarbonate, pH as well as the length of
      treatment
    

Detailed description: 
      A randomized trial of two initial volumes of IVF and subsequent administration rates. Group I
      received 10 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium
      replacement at 1.25 times maintenance and Group II received 20 mL/kg of NS intravenous bolus
      over the first hour followed by ¾ NS with potassium replacement at 1.5 times maintenance. The
      specific variables measured included demographics (age, gender, and race/ethnicity) and
      routine laboratory values (pH, pCO2, plasma glucose, electrolytes, bicarbonate, sodium,
      chloride, BUN. Length of treatment was defined as a time of the hospital stay after the start
      of IVF infusion.
    

Intervention name(s): slow fluid rate; fast fluid rate
Intervention type(s): Other; Other
Intervention description(s): 10 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.25 times maintenance; 20 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.5 times maintenance
Other intervention name(s): normal saline; normal saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ketoacidosis Fluids
Oral Treatment for Gynaecological Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to evaluate the analgesic efficacy of single and repeated doses of fixed
      combination of dexketoprofen trometamol (DKP) and tramadol hydrochloride (TRAM) in comparison
      to the single agents (and placebo for the single dose phase only).

      Approximately 600 female patients presenting moderate to severe pain after a total/subtotal
      abdominal hysterectomy are eligible to be randomised provided that they experience moderate
      to severe pain on the day after surgery.
    

Detailed description: 
      In this clinical trial patients were randomized to the described 6 treatment arms, where each
      arm define the treatment to be received in the first single dose phase (lasting 8 hours after
      the 1st treatment intake) and in the subsequent multiple-dose phase (lasting from the second
      treatment intake up to the 8 hours after the last intake). Namely:

        -  DKP/TRAM followed by DKP/TRAM;

        -  DKP followed by DKP;

        -  TRAM followed by TRAM;

        -  placebo followed by DKP;

        -  placebo followed by TRAM;

        -  placebo followed by DKP/TRAM;

      The analyses of endpoints pertinent to the single dose phase were performed combining all the
      3 treatment arms including placebo into one group, which resulted in the following 4 analysis
      groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.

      The analysis of endpoints pertinent to the multiple dose phase were performed combining the
      treatment arms including the same active treatment, which resulted in the following 3
      analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.
    

Intervention name(s): Placebo; Dexketoprofen-single dose; Tramadol-single dose; Dexketoprofen/Tramadol-single dose; Dexketoprofen-multiple doses; Tramadol-multiple doses; Dexketoprofen/Tramadol-multiple doses
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Placebo single oral dose (first 8 hours); Dexketoprofen single oral dose (first 8 hours); Tramadol single oral dose (first 8 hours); Dexketoprofen/Tramadol single oral dose (first 8 hours); Dexketoprofen multiple oral doses t.i.d. for 3 days (total 6 doses); Tramadol multiple oral doses t.i.d. for 3 days (total 6 doses); Dexketoprofen/Tramadol multiple oral doses t.i.d. for 3 days (total 6 doses)
Intervention MeSH terms: Dexketoprofen trometamol; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Moderate to severe acute pain; Postoperative pain; Abdominal hysterectomy; Analgesics; Dexketoprofen; Tramadol
Effect of Helicobacter Pylori Treatment on Idiopathic Central Serous Chorioretinopathy (ICSCR)
Condition: Central Serous Chorioretinopathy
MeSH terms: Central Serous Chorioretinopathy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Etiology of ICSCR is not known however recent studies regard the role of immunologic and
      infectious processes in the pathogenesis of ICSCR.one of these hypothesis is the role of
      helicobacter pylori in the pathogenesis of ICSCR so perhaps treatment of h pylori have
      positive effect on the remission of ICSCR.
    

Detailed description: 
      we will choose 50 cases of patients with ICSCR who are infected with h.pylori.25 cases will
      receive anti h.pylori regiment and 25 cases as controls will receive no medication.then we
      will compare the time of submacular fluid resorption and macular thickness and visual acuity
      among these two groups.
    

Intervention name(s): omeprazole, Amoxicillin, metronidazole
Intervention type(s): Drug
Intervention description(s): we will evaluate the effect of medication(anti h.pylori) on the remission of ICSCR
Other intervention name(s): treatment of Central serous chorioretinopathy
Intervention MeSH terms: Amoxicillin; Metronidazole; Omeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: CSR; Helicobacter pylori
Effects of a 12-week Strength Training Program in Men With Myotonic Dystrophy Type 1
Condition: Myotonic Dystrophy 1
MeSH terms: Myotonic Dystrophy
Study type: Interventional

Summary: 
      Eleven men with myotonic dystrophy type 1 (DM1) underwent a 12-week lower-limb strength
      training program. The training program consisted of 3 series of 6 to 8 maximal repetitions of
      5 different exercises: Leg extension, leg press, hip abduction, squat and plantar flexion.
      Training sessions were closely supervised and took place twice a week. It is hypothesised
      that the training program will induce muscular hypertrophy despite the genetic defect. The
      training program should also have positive effects on function. The participants were
      evaluated at baseline, week 6, week 12, month 6 and month 9 to see the effects of the
      training program and if these effects are maintained over time.
    


Intervention name(s): Training program
Intervention type(s): Other
Intervention description(s): 12-week strength training program of the lower limbs consisting of 5 different exercises: Leg extension, leg press, hip abduction, squat and plantar flexion. All exercises were performed between 6 and 8 maximal repetitions.
Intervention model: Sequential Assignment
Intervention model description: Participants had to complete a 12-week strength training program and return to their normal activities for the following 6 months after the end of the training program
Masking: None (Open Label)
Primary purpose: Supportive Care
Study of Pomegranate Juice on Memory in Older Adults
Condition: Impact of Pomegranate Juice on Memory in Older Adults
Study type: Interventional
Phase: Phase 2

Summary: 
      This project is designed to study whether pomegranate juice benefits cognitive abilities in
      middle-aged and older non-demented volunteers. Subjects will be randomly assigned to one of
      two treatment groups: either a placebo or the pomegranate juice. Subjects will drink eight
      ounces of the pomegranate juice or placebo daily for twelve months.

      The investigators expect the people receiving the pomegranate juice to show better cognitive
      performance compared with those receiving a placebo after one, six, and twelve months. The
      investigators believe cognitive decline and treatment response will vary according to a
      genetic risk for Alzheimer's.

      The investigators will study 212 non-demented subjects aged 50-75 years. Initially, subjects
      will undergo a clinical assessment, an MRI and a blood draw to determine genetic risk and to
      rule out other neurodegenerative disorders linked to memory complaints.

      Subsequently, subjects will undergo the first memory (or neuropsychological) assessments.
      Following the first assessment, subjects will begin drinking the juice (either the
      pomegranate juice or the placebo). Subjects will undergo a brief memory test at one-month
      mark. At six months, subjects will have a second, full neuropsychological assessment. The
      final assessment will take place at the end of the study, the 12-month mark. Additional blood
      will be drawn at baseline and at 12 months and frozen to assess inflammatory markers if
      outcomes are positive.

      In total, subjects will be expected to come to the University of California, Los Angeles
      (UCLA) for 5 visits during the course of 12-13 months.
    


Intervention name(s): Pomegranate Juice; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Double-blind Trial; Placebo-controlled; Pomegranate; Memory; Memory Impairment; Cognition; Ages 50-75
Single-probe Microwave Ablation (MWA) of Metastatic Liver Cancer
Condition: Liver Neoplasms
MeSH terms: Liver Neoplasms
Study type: Interventional

Summary: 
      Microwave ablation (MWA) is the most recent development in the field of local ablative
      therapies. The aim of this study was to evaluate the variability and reproducibility of
      single-probe MWA versus radiofrequency ablation (RFA) of metastatic liver tumours smaller
      than 3 cm in patients without underlying liver disease.
    


Intervention name(s): Microwave ablation; Radiofrequency ablation
Intervention type(s): Device; Device
Intervention description(s): Liver tumors are destructed/ablated using single-probe microwave energy device; Liver tumors are destructed/ablated using radiofrequency energy device
Other intervention name(s): MW ablation antenna (VT2237) and a 915 MHz Valleylab MW generator (VTSYS3; Covidien, Europe NV)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: malignancy; liver; microwave; surgery
The Effect of a Plant-blend Protein Isolate on Post-exercise Myofibrillar Protein Synthesis
Condition: Muscle Metabolism
Study type: Interventional

Summary: 
      Dietary protein ingestion is required to maximise the anabolic response during the recovery
      from resistance exercise. Whey protein is considered the optimal dietary strategy to maximise
      post-exercise muscle protein synthesis, but animal-protein production and consumption is
      associated with growing environmental and ethical concerns. Plant-based protein sources are
      considered of lesser anabolic quality than isonitrogenous boluses of animal-derived protein
      attributed to, at least in part, deficiencies in key essential amino acid. Blending different
      protein sources may overcome amino acid deficiencies and potentiate the post-exercise
      anabolic response. In the present study the investigators assessed the post-exercise muscle
      protein synthetic response following the ingestion of a novel plant-based protein isolate
      when compared with an isonitrogenous bolus of whey protein in healthy young, resistance
      trained women and men.
    


Intervention name(s): Bilateral resistance exercise; Whey protein; Plant-blend protein
Intervention type(s): Behavioral; Dietary Supplement; Dietary Supplement
Intervention description(s): A bout of bilateral resistance exercise consisting of barbell back squat, leg leg press and leg extension; Following execution of bilateral resistance exercise, participants will ingest 32 g protein from whey protein isolate; Following execution of bilateral resistance exercise, participants will ingest 32 g protein from plant-blend protein isolate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Myofibrillar Protein Synthesis; Resistance Exercise; Plant Protein; Stable Isotopes
Intestinal Microbiota, Tryptophan and Autism
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Observational

Summary: 
      Autism Spectrum Disorder refers to complex neuro-developmental disorders that affect social
      communication and behavioral adaptation. Currently, the diagnosis of Autism Spectrum Disorder
      is based on a clinical examination that is performed classically during the first three years
      of life. The heterogeneity of the disorders occurring in autism make pathologies difficult to
      diagnose and manage.

      The overall goal of this project is the identification of metabolic biomarkers based on
      clinical profile. The best characterization of physiopathological pathways will ultimately
      allow the identification of subgroups of subjects and facilitate the development of targeted
      therapeutics.

      The proposed work aims to test the hypothesis of a disruption of tryptophan metabolism in
      Autism Spectrum Disorder via the gut microbiota.
    

Detailed description: 
      Autism Spectrum Disorder refers to complex neuro-developmental disorders that affect social
      communication and behavioral adaptation. In France, Autism Spectrum Disorderaffects about 1
      in 100 people according to international criteria and is diagnosed in early childhood.
      Currently, the diagnosis of Autism Spectrum Disorder is based on a clinical examination that
      is performed classically during the first three years of life. The heterogeneity of the
      disorders occurring in autism make pathologies difficult to diagnose and manage.

      The overall goal of this project is the identification of metabolic biomarkers based on
      clinical profile (based on behavioral and cognitive markers). The best characterization of
      physiopathological pathways (from the molecular scale to the phenotypic scale) will
      ultimately allow the identification of subgroups of subjects and facilitate the development
      of targeted therapeutics.

      The proposed work aims to test the hypothesis of a disruption of tryptophan metabolism in
      Autism Spectrum Disorder via the gut microbiota.
    

Intervention name(s): Samples
Intervention type(s): Other
Intervention description(s): Urinary and faecal samples
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        3-12 year old children with and without Autism Spectrum Disorders
      
Biospecimen description: 
      Urinary and faecal samples
    
Keywords: Autism Spectrum Disorder; Tryptophan metabolism; Gut microbiota
A Study to Assess the Bioequivalence of Ustekinumab by Two Different Injection Devices in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetic (PK) and bioequivalence (BE) of
      ustekinumab administered by a single subcutaneous (SC) injection with Device 1 or Device 2 in
      healthy participants.
    


Intervention name(s): Ustekinumab
Intervention type(s): Drug
Intervention description(s): Ustekinumab will be administered as SC injection.
Other intervention name(s): CNTO1275, STELARA
Intervention MeSH terms: Ustekinumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
A Comparison of McGrath MAC Videolaryngoscopy and Macintosh Laryngoscopy for Orotracheal Intubation in Children
Condition: Anesthesia, Endotracheal
Study type: Interventional

Summary: 
      The primary purpose of this study is to investigate the effects of McGrath MAC
      videolaryngoscopy on the intubation time for orotracheal intubation in children.

      The secondary purpose of this study is to investigate the effects of McGrath MAC
      videolaryngoscopy on Cormack and Lehane Grade for orotracheal intubation in children.
    


Intervention name(s): McGrath MAC videolaryngoscopy; Macintosh Laryngoscopy
Intervention type(s): Device; Drug
Intervention description(s): Orotracheal intubation with McGrath MAC videolaryngoscopy after anesthetic induction; Orotracheal intubation with Macintosh Laryngoscopy after anesthetic induction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly
Condition: Hepatitis B; Diphtheria; Haemophilus Influenzae Type b (Hib); Poliomyelitis; Pertussis; Tetanus
MeSH terms: Hepatitis B; Diphtheria; Poliomyelitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the immunogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly
      SmithKline Beecham Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared to the
      separate administration of DTPa-HBV-IPV (Infanrix™ penta) and Hib (Hiberix™) vaccines
      administered at 3 and 5 months of age.
    


Intervention name(s): DTPa-HBV-IPV/Hib (Infanrix-hexa™); DTPa-IPV/Hib (Infanrix-IPV/Hib™); HBV (Engerix™-B)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8; 3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8; 3 doses administered intramuscularly into the left thigh at study month 0, 2 and 8
Intervention MeSH terms: Edetic Acid; Pentetic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Infants; combined vaccine; DTPa-HBV-IPV/Hib; DTPa-IPV/Hib; safety; Immunogenicity; HBV
Fate of Nutrient-Derived Amino Acids, FONDAA
Condition: Protein Utilization; Dietary Protein
Study type: Interventional

Summary: 
      12 elderly (65-70 years of age) male subjects will be included and complete a double blinded
      cross-over study. They will be habituated for 21 days to either low or high protein intake
      (below 0.8 g/kg or above 1.5 g/kg, respectively). Following a 45 day washout period they will
      switch to the alternate group. At the end of each habituation period, the investigators will
      measure the appearance of labelled amino acids from milk proteins.
    


Intervention name(s): Meal serving at high dietary protein; Meal serving at low dietary protein; Meal serving
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Participants are habituated to a high level of dietary protein intake for 21 days.; Participants are habituated to a low level of dietary protein intake for 21 days.; To investigate impact of habituated protein level
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Required dietary protein; Amino acid; Splanchnic extraction