bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Effect of Appropriate Sedation for Patients After Abdominal Surgeries : A Prospective Randomised Controlled Study
Condition: Postoperative Sedation, Abdominal Surgery
Study type: Interventional

Summary: 
      To evaluate the efficacy and safety of appropriate postoperative sedation with
      dexmedetomidine for patients after abdominal surgeries.Prospective randomised controlled
      study was conducted among patients after abdominal surgeries began in October 2015.The
      investigators enroll patients who received abdominal surgeries. One group receive sedative
      along with analgesic and the other group analgesic only for the other group on the first 24
      hours after surgeries and will follow up for 3 days.
    


Intervention name(s): Dexmedetomidine, tramadol and flurbiprofen; tramadol and flurbiprofen
Intervention type(s): Drug; Drug
Intervention MeSH terms: Flurbiprofen; Dexmedetomidine; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cone Beam Computed Tomography for Evaluating Corticotomy-assisted Maxillary Expansion
Condition: Posterior Cross Bite
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      Maxillary expansion was performed for adult female patients suffering from maxillary
      constriction with bilateral posterior cross-bite using fixed Quad-helix appliance, for about
      8 months. The appliance was delivered and activated at the day of corticotomy and bone graft.
      The activation was made half-molar unit each side. The patient was scheduled each month to
      activate the appliance or reactivate if needed. Corticotomy was performed at area of
      maxillary 1st premolar, 2nd premolar and first molar. Cone beam computed tomography was
      performed, before appliance activation and corticotomy, at the end of expansion (8 months)
      and after finishing orthodontic treatment (average 2.5 years from start of treatment).
    

Detailed description: 
      Maxillary expansion was performed for adult female patients suffering from maxillary
      constriction with bilateral posterior cross-bite & dental arch discrepancy average 12 mm
      using fixed Quad-helix appliance, for about 8 months. The appliance was delivered and
      activated at the day of corticotomy and bone graft (demineralized freeze-dried bone
      allograft). The activation was made half-molar unit each side. The patient was scheduled each
      month to activate the appliance or reactivate if needed. Corticotomy was performed at area of
      maxillary 1st premolar, 2nd premolar and first molar. Cone beam computed tomography was
      performed at three stages.

      T1 (baseline) Before appliance activation and corticotomy. T2 At the end of expansion. (about
      8 months of expansion). T3 At the finishing stage of orthodontic treatment (average 2.5 years
      from start of treatment).
    

Intervention name(s): flap with corticotomy and bone allograft
Intervention type(s): Procedure
Intervention description(s): A maxillary expansion with quad helix appliance was placed on the posterior teeth with cross bite. A Luebke buccal flap was opened in the area of maxillary 1st premolar, 2nd premolar and first molar with a no. 15 scalpel. Corticotomy procedure was performed using low speed round bur size 3, holes to create a 0.5 mm deep hole penetrating the cortical bone. Multiple holes were performed leaving 1.5 mm distance in between. The defects were covered with demineralized freeze-dried bone allograft and the flap was sutured in its original position with 3-0 black silk suture.
Other intervention name(s): periodontally accelerated orthodontics and DFDBA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Study to Investigate the Effects of Creatine Supplementation on Muscle Energetics and Cognitive Function in Young Healthy Male Athletes and an Ageing Population
Condition: Nutritional Status
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will examine the impact of creatine supplementation on muscle function and
      cognitive performance in young and older subjects.
    

Detailed description: 
      This is a randomised, double-blind study of the effects of creatine supplementation on muscle
      energetics and cognitive function, using 31P-MRS and fMRI. 31P-MRS data will be acquired
      continuously during exercise phase and in the post-exercise metabolic recovery phase.
      Participants will undergo a fMRI scan of the brain to record changes in the blood oxygen
      level dependent (BOLD) signal during a series of cognitive tests. In addition, participants
      will undergo a resting state BOLD scan and a structural MRI scan for localization of brain
      regions.
    

Intervention name(s): Creatine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Creatine powder (5 g); Bulking agent powder (5 g)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Creatine; Functional magnetic resonance imaging (fMRI); Phosphorus-31 magnetic resonance spectroscopy (31P-MRS)
ADDITION OF BISMUTH TO THE STANDARD TRIPLE THERAPY FOR HELICOBACTER PYLORI ERADICATION
Condition: Helicobacter Pylori Infection
Study type: Interventional
Phase: Phase 2

Summary: 
      H pylori is an important cause of chronic gastritis and other complications. There is a
      decline in eradication rate for H pylori owing to multiple factors including drug resistance.
      We compare the effect of the addition of bismuth to the standard triple therapy in a
      randomized control trial.

      Subjects were randomized into two arms. Arm A received triple therapy including amoxicillin,
      clarithromycin, and omeprazole and Arm B received quadruple therapy adding colloidal bismuth
      subcitrate. Both arms received treatment for two weeks.
    

Detailed description: 
      The study is a 2-arm, prospective, randomized, non-inferiority, unblinded, parallel design
      trial. The primary end point is post-treatment result after triple or quadruple therapy.
      Secondary endpoints included the nature and frequency of side effects compared between the
      two arms. The study protocol was approved by the ethical review committee of the university.

      Patients with dyspeptic symptoms who had H pylori infection, diagnosed through positive Stool
      for H pylori antigen or presence of H. pylori organism in the histopathology of gastric
      mucosal biopsy, attending outpatient department of two campuses of the University Hospital
      were included in this study.. Group A received standard triple therapy for H. pylori
      eradication for a total 14 days and group B received bismuth-based quadruple therapy for H
      pylori eradication for the same period. The triple regimen was defined as a combination of
      amoxicillin 1 gm twice a day, clarithromycin 500 mg twice a day and omeprazole is given in 40
      mg twice a day dose. Quadruple therapy included colloidal bismuth subcitrate 240 mg twice
      daily, in addition. H. Pylori status was checked routinely after 6 weeks by Stool sampling
      for H, pylori antigen. Subjects were counseled to stop taking PPI or any antibiotic 2 weeks
      before stool H. pylori antigen testing. Eradication of H pylori was defined as lack of
      detection of H pylori antigen in the stool via ELISA method after triple or quadruple
      therapy.
    

Intervention name(s): ARM A Triple therapy for helicobacter pylori; ARM B Quadruple therapy for helicobacter pylori
Intervention type(s): Drug; Drug
Intervention description(s): The triple regimen was defined as a combination of amoxicillin 1 gm twice a day, clarithromycin 500 mg twice a day and omeprazole is given in 40 mg twice a day dose.; Quadruple therapy included colloidal bismuth subcitrate 240 mg twice daily,amoxicillin 1 gm twice a day, clarithromycin 500 mg twice a day and omeprazole is given in 40 mg twice a day dose.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: PARALLEL ASSIGNMENT
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: H pylori; eradication; amoxicillin; clarithromycin; esomeprazole; colloidal bismuth subcitrate
Study of Combination Treatment With IMO-2125 and Ribavirin in Naïve Hepatitis C-infected, Genotype 1 Patients
Condition: Hepatitis C, Treatment Naïve, Genotype 1 Patients
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1, randomized, double-blind, placebo-controlled, dose-escalation study with 3 dose
      levels of IMO-2125 in combination with standard weight based ribavirin (investigational
      treatment arm) or placebo in combination with ribavirin (RBV). Each cohort of 15 patients
      will be randomized 4:1 to receive the investigational treatment arm (12 patients) or placebo
      and RBV arm (3 patients).
    

Detailed description: 
      This is a phase 1, randomized, double-blind, placebo-controlled, dose-escalation study with 3
      dose levels of IMO-2125 in combination with standard ribavirin or placebo plus ribavirin.
      Each cohort will be randomized 4:1 to receive the investigational treatment arm or placebo
      and ribavirin. Three varying dose levels of IMO-2125 will be included. In both arms,
      ribavirin will be dosed based on patient weight.

      Approximately 50 patients will be enrolled in France and Russia. Patients will provide
      informed consent prior to any screening procedures being performed. Screening will occur
      within 21 days prior to randomization. Enrolled patients who qualify and proceed successfully
      through the screening period will be randomized to receive 4 weeks of either the
      investigational treatment arm (IMO-2125 and ribavirin) or placebo and ribavirin, with a 4
      week follow-up period.

      Patients who are randomized to the investigational treatment arm will receive one of 3 dose
      levels of IMO 2125 SC once weekly; each patient will receive the same dose throughout the 4
      weeks of treatment. In addition to IMO-2125 treatment they will also receive daily ribavirin,
      which will be given based on the patients weight and will be taken twice daily for a total of
      4 weeks.
    

Intervention name(s): IMO-2125; Saline
Intervention type(s): Drug; Drug
Intervention description(s): IMO 2125 is a synthetic DNA-based agonist of Toll-like receptor 9, which is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system.; Subcutaneous injection once per week for four weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Trial Assessing Changes in Blood Sugar and the Number of Periods Where Supplementation of Carbohydrate is Needed to Treat Low Blood Sugar, During Two Different Treatment Regimens of NN1250 in Type 1 Diabetics
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim is to compare changes in blood sugar and the
      number of periods where carbohydrate supplementation is needed to treat low blood sugar,
      during two different treatments with NN1250 (insulin degludec), a soluble insulin basal
      analogue (SIBA) in subjects with type 1 diabetes.
    


Intervention name(s): insulin degludec; insulin degludec; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Insulin degludec injected s.c. (under the skin) three times weekly; Insulin degludec injected s.c. (under the skin) once daily for one week; Placebo injected s.c. (under the skin) four times weekly
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin, Long-Acting
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Retrieval and Analysis of Orthopedic Implants at Revision Arthroplasty Surgery
Condition: Total Joint Revisions
Study type: Observational

Summary: 
      The goal of this is to improve durability of total joint replacements in patients, thereby
      improving clinical outcomes and implant performance. To reach this objective, our research
      program would like to assess the safety, efficacy, performance, and durability of FDA
      approved biomaterial and implant designs used in joint replacements.
    

Detailed description: 
      The objective of the investigation will be to determine the mechanism of material failure and
      identify any design features that put the implant at risk for early failure. Normally all
      implants are discarded. The investigators will collect the implants indicated for removal and
      if there are impressive findings the investigators will perform research on the implants,
      otherwise the implants will be discarded. All patients will be followed prospectively after
      informed consent is signed. The implants that are chosen for research will be assessed for
      implant wear and failure at a lab appropriate for evaluating the particular concern.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing revision total joint surgery.
Single-dose Pharmacokinetics and Relative Bioavailability of an Oral Suspension and Two Tablet Formulations of BIA 2-093
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      Single centre, open-label, randomised, three-way crossover study in 18 healthy subjects (9
      males and 9 females). The study consisted of three consecutive single-dose treatment periods
      separated by a washout period of 7 days or more. On each treatment period, the volunteers
      received a single dose of BIA 2-093 800 mg, orally.
    

Detailed description: 
      Sample size (planned and analyzed): It was planned to have at least 16 healthy subjects
      completed and evaluable. Taking into account the potential occurrence of dropouts, two
      additional subjects were to be recruited and entered the study. Therefore, a total of 18
      subjects were enrolled.

      Diagnosis and main selection criteria: Healthy male or female volunteers aged between 18 and
      45 years, with body mass index between 19 and 28 kg/m2, non-smokers or smoking less than 10
      cigarettes or equivalent per day.
    

Intervention name(s): BIA 2-093; BIA 2-093; BIA 2-093
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral suspension 50 mg/mL; 200 mg tablet; 800 mg tablet
Other intervention name(s): ESL, Eslicarbazepine acetate; ESL, Eslicarbazepine acetate; ESL, Eslicarbazepine acetate
Intervention MeSH terms: Eslicarbazepine acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Blood Pressure Monitoring in Hypertensive Populations: Device Testing, Feasibility, Acceptability
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The goal of this study is to test a novel cuffless blood pressure (BP) monitoring device
      (BIO-Z) within adults with hypertension (high blood pressure) for clinical use.

      The main questions it aims to answer are:

        -  To validate a novel cuffless blood pressure (BP) monitoring device (BIO-Z) within adults
           with hypertension (high blood pressure)

        -  To assess BP monitoring accuracy, against reference BP measurements captured by a
           Finapres Nova® continuous BP monitoring device in correspondence with blood pressure
           monitoring devices standards.

      Researchers will test the device against the Finapres Nova® blood pressure monitoring device.
    

Detailed description: 
      The purpose of this study is to evaluate a novel cuffless blood pressure monitoring device
      for clinical use. This device is a cuffless blood pressure watch worn on the wrist called
      BIO-Z. The device will be tested against the Finapres Nova® which is FDA-approved to capture
      continuous BP measurements. The participant will only need wear a wristband, potentially
      eliminating the need to perform cuff-based readings. During the 2-hour visit, research
      coordinators will conduct exercises to change BP and compare the values gathered by the BIO-Z
      watch with the Finapres Nova® device and a standard blood pressure cuff. The investigators
      will also test whether the Bio-Z can capture blood pressures that are in the low and high
      range, and whether motion affects the quality of measurement. The ultimate goal is to develop
      a device that passively collects blood pressure continuously, which is more convenient than a
      standard blood pressure cuff. 15 Participants will have the option to complete study
      procedures twice more, spaced one week apart, for a total of three weeks of participation.
    

Intervention name(s): BIO-Z; Finapres Nova
Intervention type(s): Device; Device
Intervention description(s): a novel cuffless continuous BP wrist monitor; a cuffless continuous BP monitor
Intervention model: Single Group Assignment
Intervention model description: Each visit will take at most 2 hours to complete study exercises. 15 Participants will have the option to complete study procedures twice more, spaced one week apart, for a total of three weeks of participation.
Masking: None (Open Label)
Primary purpose: Prevention
Treatment of Myeloma in Patients <= 65 Years Old With Response >= 50% After HSC Autotransplant by Allogenic Transplant Genoidentical or Phenoidentical After Reduced Intensity Conditioning
Condition: Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      Donor mobilization :

      Donor will be mobilized with G-CSF (Granocyte) sub-cutaneous 10 µg/kg/day during 5 to 6 days.

      Hematopoïetic Stem Cell Harvest:

      By 1, 2, or 3 aphaeresis, a number of 4 x 106 cellules CD34+ /kg is required. If the CD34+ >=
      2 and <= 4x106/kg: the center must decide on the strategy Decision. In case of insufficient
      graft : a Bone Marrow Harvest is recommended Conditioning : Fludarabine - Busulfan - ATG

        -  D-5 : Fludarabine (30 mg/m²)

        -  D-4 : Fludarabine (30 mg/m²)+ Busilvex (0,8 mg/kg every 6 h)

        -  D-3 : Fludarabine (30 mg/m²)+ Busilvex (0,8 mg/kg every 6 h)

        -  D-2 : Fludarabine (30 mg/m²) + ATG (Genzyme) (2.5 mg/Kg)

        -  D-1 : Fludarabine (30 mg/m²) + ATG (Genzyme) (2.5 mg/Kg) GVHD Prophylaxis: CsA alone at
           3 mg/ kg + Methotrexate D1, D3 and D6 only in case of minor ABO incompatibility and with
           an anti A/B antibodies titer> 1/32.

      Transplant : HSC at D0

      • 3 months after Transplantation :

      Disease Evaluation :

        -  If CR : Supervision. Then if progression: 4 cycles of Bortezomib.

        -  If no CR : Bortezomib (4 cycles)

           • Evaluation after Bortezomib cycles

        -  If CR : Supervision. Then, if progression and no GvHD : DLI If no RC and no GVHD : DLI
    


Intervention name(s): reduced intensity conditioning
Intervention type(s): Drug
Intervention description(s): reduced intensity conditioning for allogenic transplant
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Myeloma; RICT; conditioning; allograft
Durability of Combination Therapy With Exenatide/Pioglitazone/Metformin vs. Conventional Therapy in New Onset T2DM
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      Type 2 diabetes is a systemic metabolic disease with significant morbidity and mortality due
      to damaging blood vessels. Increased blood sugar level is a hallmark of diabetes and is an
      contributes to the development of many of its complications. Multiple defects, e.g. impaired
      insulin secretion and impaired insulin action, contribute to the development of the disease.
      The aim of this study is to test the efficacy and durability of combination of drugs which
      correct the defects that lead to the development of diabetes on achieving adequate and
      durable control of blood sugar levels. Achieving adequate and durable control of blood sugar
      will prevent many of diabetes complications.
    


Intervention name(s): metformin\pioglitazone\exenatide; metformin, glyburide and glargine
Intervention type(s): Drug; Drug
Intervention description(s): metformin (1000 mg), pioglitazone (15 mg) and exenatide (5 microgram bid) are started and dose is up titrated to achieve HbA1c < 6.5%; subjects are started on metformin 500 mg bid and dose is up titrated and glyburide (up to 5 mg) and glargine are sequentially added to maintain HbA1c < 6.5%
Intervention MeSH terms: Metformin; Pioglitazone; Exenatide; Glyburide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 2 diabetes; new onset; combination therapy; new onset type 2 diabetes
A Study of HB0017 in Patients With Moderate to Severe Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, dose-escalation Phase Ib study to
      evaluate the safety, tolerability, and pharmacokinetics of HB0017 following multiple dose in
      patients with moderate to severe plaque psoriasis.
    

Detailed description: 
      The study is a randomized, double-blinded, placebo-controlled, multiple dose-escalation study
      to evaluate the safety, tolerability, PK and immunogenicity of HB0017 in patients with
      Moderate to severe plaque psoriasis be given HB0017 at doses of 150mg, 300mg and 450mg or
      placebo by SC administration every 3 weeks. Each cohort of 10 subjects is randomly assigned
      to receive either a single dose of HB0017 or matching placebo at a ratio of 4:1. Each subject
      receive injection at week0(Day1), week 3(Day22), week 6(Day43) and week 9(Day64),
      respectively. After the evaluation and unblinding is completed at week 12(Day 85), the
      subjects in placebo group completed all study periods, and the HB0017 group continued to be
      followed up until the end of week 20(D141).
    

Intervention name(s): HB0017 150mg or matching placebo; HB0017 300mg or matching placebo; HB0017 450mg or matching placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Each subject receive injection at week0(Day1), week 3(Day22), week 6(Day43) and week 9(Day64), respectively.; Each subject receive injection at week0(Day1), week 3(Day22), week 6(Day43) and week 9(Day64), respectively.; Each subject receive injection at week0(Day1), week 3(Day22), week 6(Day43) and week 9(Day64), respectively.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Single and Multiple Oral Doses of Dabigatran Etexilate in Healthy Chinese Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the current study is to investigate safety, tolerability and,
      pharmacokinetics of dabigatran etexilate following oral administration of single and multiple
      oral doses (110mg, 150 mg b.i.d., 7 days) in healthy Chinese subjects.
    


Intervention name(s): Dabigatran etexilate low; Dabigatran etexilate high
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dabigatran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment