bioihbjkbjnl/mcl2 huggingface dataset:
Oral Self Medication Versus IV Administration of Pain Killers After Caesarian Delivery
Condition: Caesarian Section
Study type: Interventional
Phase: Phase 4

Summary: 
      C-section deliveries are painful and need adequate analgesia. In the same time, mothers need
      early rehabilitation to take care of the baby.

      Hypothesis: Early oral self administration of painkillers could be as effective as usual IV
      administration by nursing staff.

      Purpose of the study: Evaluation of the efficacy of a program of self administration of
      painkillers postoperatively of C-section delivery.
    

Detailed description: 
      Two Arms: PCOA group receiving oral self administered multimodal analgesic protocol and IV
      group receiving same multimodal analgesic protocol administered by nursing staff.
    

Intervention name(s): Acetaminophen, ketoprofen, morphine; Acetaminophen, ketoprofen,morphine
Intervention type(s): Drug; Drug
Intervention description(s): Acetaminophen 0.5g, maximum 4g by day, 48 hours ketoprofen 100 mg, twice a day, 48 hours Morphine 10 mg, maximum 90 mg by day, 36 hours; Acetaminophen 1g/100 ml IV, maximum 4g by 24 hours, 48 hours Ketoprofen IV, maximum 0,2 gram by 24 hours, 48 hours Morphine IV,maximum 60mg by 24 hours, 36 hours.
Other intervention name(s): dolipraneoro 500mg, MA 352 120-2; bi profenid LP 100 mg, MA 399804-5; Actiskenan 10 mg, MA 561958-9; Paracetamol 1g/100 ml IV : MA #571860-1; Profenid IV : MA #557466-8; Morphine IV : MA #566945-2
Intervention MeSH terms: Acetaminophen; Ketoprofen; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: planned caesarian section, analgesic, PCOA
Tomographic Evaluation of Pulpotomy in Young Permanent Teeth Using Human-treated Dentin Matrix
Condition: Pulpotomy of Young Permanent Molars
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Assess tomographic outcomes of pulpotomy in young permanent molars using human-treated dentin
      matrix versus MTA.
    

Detailed description: 
      The study was conducted as a split-mouth randomized clinical trial, approved by research
      ethics committee, Faculty of Dentistry, Tanta University, and carried out at Pediatric
      Dentistry Department, Faculty of Dentistry, Tanta University. The material preparation was
      conducted at Pharmaceutical Technology Department, Faculty of Pharmacy, Tanta University. 20
      children of both sexes aged from 6 to 8 years old were selected with bilateral deeply carious
      young permanent mandibular first molars that are indicated for pulpotomy procedure.The
      selected deeply carious molars were randomly divided into two groups as follows:

      Group I (Study group): 20 molars were treated with hTDM. Group II:

      (Control group): 20 molars were treated with White MTA. The participating cases were
      evaluated clinically 3, 6, 12 and 18 months. Digital periapical radiographs was taken at 6
      month follow-up period to ensure the state of the treated teeth or if there was necessary
      condition.

      Tomographic evaluation was performed immediate postoperatively and at 18 months.
    

Intervention name(s): human treated dentin matrix; Mineral Tri-Oxide Aggregate
Intervention type(s): Drug; Drug
Intervention description(s): human treated dentin matrix is compared with mineral trioxide aggregate in apexogenesis; mineral trioxide aggregate was used as control
Other intervention name(s): human partially demineralized treated dentin matrix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
To Compare the Efficacy and Safety of BP102 vs. Avastin® in Combination With Paclitaxel/Carboplatin in First-line Treatment of Advanced or Relapsed NSCLC
Condition: Non-small Cell Lung Cancer(NSCLC)
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind, positive parallel control, multicentre Phase III clinical
      trial, a clinical trial of biosimilar drugs, so the type of comparison is equivalence test.
    


Intervention name(s): BP102, paclitaxel, carboplatin; Avastin®, paclitaxel, carboplatin
Intervention type(s): Drug; Drug
Intervention description(s): BP102, paclitaxel, carboplatin; Avastin®, paclitaxel, carboplatin
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Carboplatin; Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: BP102 in combination with paclitaxel/carboplatin compared with Avastin® in combination with paclitaxel/carboplatin
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
TAP Block and Subacute Pain in Inguinal Herniography
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Inguinal hernia repair with mesh has a high incidence of postoperative chronic pain.
      Transversus abdominis plane block is a current intervention to support postoperative
      analgesia, however it is recently in research area how to be applied in different surgical
      areas to be more effective than intravenous opioids. Subcostal transversus abdominis plane
      block is not advised but has not been studied to be effective for postoperative analgesia in
      inguinal herniography patients.

      This study aims to research the effect of subcostal transversus abdominis plane block in
      subacute postoperative pain after inguinal hernia repair
    

Detailed description: 
      Patients were divided into two groups, one is control and the second is subcostal transversus
      abdominis plane block (STAP) group. After standard general anesthesia application, control
      group ( Group I) had 1 gram of paracetamol and 100 mg of contramal just after starting
      surgical closure. Group II (STAP) had 1 gram of paracetamol and 100 mg of contramal, after
      surgical closure transversus abdominis plane block in subcostal area was applied to the
      patient.
    

Intervention name(s): transversus abdominis plane block; Tramadol and paracetamol
Intervention type(s): Procedure; Drug
Intervention description(s): A peripheric block needle is inserted entering the facia between musculus rectus abdominis and musculus transversus abdominis with ultrasonography and local anesthetics are injected in the facia.; Tramadol 100 mg and paracetamol 1000 mg are applied to the patients at the end of the surgery
Other intervention name(s): stimuplex A; contramal; parol infusion solution
Intervention MeSH terms: Acetaminophen; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: TAP block; subacute pain; inguinal herniography
Bioequivalence Study of Minocycline HCl 135 mg ER Tablet Sunder Fed Conditions
Condition: Healthy
Study type: Interventional

Summary: 
      The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,
      two-sequence, single-dose, crossover, bioequivalence study comparing Minocycline
      hydrochloride extended release tablets 135 mg manufactured by OHM Laboratories Inc. with
      SolodynTM extended release tablets 135 mg manufactured by AAI Pharma, Inc Wilmington, NC
      28405 and manufactured for Medicis, The Dermatology Company Scottsdale, AZ 85258 in healthy,
      adult, human, male subjects under fed conditions.
    

Detailed description: 
      Test for drugs of abuse (opiates and cannabinoids) in urine and breath test for alcohol were
      carried out prior to admission in each period of the study. Following an overnight fast of at
      least 10 hour, a high-fat high-calorie breakfast was served to the study subjects.

      Thirty minutes after start of this breakfast, a single oral dose of minocycline hydrochloride
      extended release tablet 135 mg of either test or reference investigational product was
      administered during each period of the study, along with 240 mL of drinking water at ambient
      temperature under low light condition and under supervision of trained study personnel.

      During the course of the study, safety parameters assessed were vital signs, clinical
      examination, medical history and clinical laboratory safety tests (hematology, biochemical
      parameters, serology and urine analysis) at baseline. Adverse event monitoring was done
      throughout the study. Laboratory parameters of hematology and biochemistry (except blood
      glucose and cholesterol) were repeated at the end of the study.
    

Intervention name(s): Minocycline hydrochloride
Intervention type(s): Drug
Intervention description(s): extended release tablets 135 mg
Intervention MeSH terms: Minocycline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Pain Neuroscience Education in Patients With Fibromyalgia
Condition: Pain, Chronic; Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Chronic Pain
Study type: Interventional

Summary: 
      Many patients with fibromyalgia have little understanding of their condition, leading to
      maladaptive pain cognitions and coping strategies. Current research has suggested the use of
      physiotherapy and rehabilitation in addition to cognitive patient education in the treatment
      of fibromyalgia syndrome. This study aimed to explore the effectiveness of pain neuroscience
      education in patients with fibromyalgia.
    


Intervention name(s): Pain neuroscience education; Medical treatment
Intervention type(s): Other; Drug
Intervention description(s): A total of 4 NPE (Neuroscience paine education) sessions were held, once each week in addition medical treatment similar to control group. The NPE sessions were conducted by an experienced physiotherapist certified in NPE in face-to-face, group sessions lasting 40-45 minutes. In NPE, the patient is taught about the physiology of pain, central sensitization, representation of the different body regions in the brain, pain-related changes in body perception, and the psychosocial dimensions of pain.; The patients in control group continued taking their regular gabapentin and pregabalin-derivative drug therapy at the same dosage and duration specified by their physicians.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: pain neuroscience education; patient education
Use of an Ocular Telemetry Sensor in Diamox Treated Patients
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Study type: Interventional

Summary: 
      A soft contact lens integrating a Sensor is placed on subjects with high intraocular pressure
      (IOP) after administration of an IOP-lowering drug to investigate the device's capacity to
      detect the induced IOP reduction.
    


Intervention name(s): SENSIMED Triggerfish
Intervention type(s): Device
Intervention description(s): 2-hour continuous IOP monitoring
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Glaucoma and ocular hypertension patients
A Study in Healthy Men to Measure the Amount of BI 730357 in the Blood When Taken as a Tablet
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the absolute oral bioavailability of BI 730357 administered as tablet compared
      with [C-14]BI 730357 BS administered as intravenous microtracer
    


Intervention name(s): BI 730357; BI 730357 mixed with [C-14] BI 730357 BS
Intervention type(s): Drug; Drug
Intervention description(s): Oral dose; Intravenous dose
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Exposure Therapy For Veterans With PTSD And Panic Attacks
Condition: PTSD; Panic Attacks
MeSH terms: Panic Disorder
Study type: Interventional

Summary: 
      To evaluate the feasibility, acceptability and effectiveness of Multiple Channel Exposure
      Therapy-Veterans (MCET-V) as a treatment for returning service members with comorbid PTSD and
      panic disorder (PD). This study will examine the effectiveness of MCET-V by comparing it to
      Cognitive Processing Therapy, a standard PTSD treatment.
    

Detailed description: 
      With the increasing number of Operations Iraqi Freedom and Enduring Freedom (OIF/OEF)
      Veterans returning from war-zone areas, many will experience anxiety disorders such as PTSD
      and comorbid problems. Currently, about one in every six OIF/OEF Veterans experiences PTSD
      and co-occurring PD. Although effective treatments exist for treating one or the other, we do
      not yet have treatments that can simultaneously target PTSD and PD. Thus, recent attention
      has focused on the development of multi-component treatments that simultaneously address PTSD
      and PD. This study is the first systematic investigation of a time-limited, multi-component
      cognitive-behavioral treatment for Veterans with specific comorbid anxiety problems. The
      purpose of the study is to evaluate the effectiveness of the multi-component
      cognitive-behavioral treatment in comparison to standard PTSD treatment in military personnel
      returning from active duty.
    

Intervention name(s): Multiple Channel Exposure Therapy - Veterans; Cognitive Processing Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): MCET-V offers individual therapy that provides psychoeducation about panic attacks and trauma and involves behavioral and cognitive exposure exercises.; CPT offers individual therapy that targets trauma and PTSD symptoms via cognitive restructuring.
Other intervention name(s): MCET-V; CPT
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Multiple Channel Exposure Therapy is a behavioral treatment that simultaneously targets panic disorder and PTSD.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Open-Label Extension Study Of Safety And Tolerability Of Pregabalin In Pediatric Patients With Partial-Onset Seizures
Condition: Epilepsies, Partial
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will evaluate the long-term safety and tolerability of pregabalin in pediatric
      patients, age 1 month through 16 years, with partial onset seizures.
    


Intervention name(s): Pregabalin
Intervention type(s): Drug
Intervention description(s): Orally-administered pregabalin
Intervention MeSH terms: Pregabalin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Partial-onset seizures; epilepsy; pediatric; pregabalin; 1 year extension study; safety; tolerability
Psychiatric Day Hospital Treatment
Condition: Depressive Disorders; Schizophrenia; Anxiety Disorders; Personality Disorders; Adjustment Disorders
MeSH terms: Schizophrenia; Depressive Disorder; Anxiety Disorders; Personality Disorders; Adjustment Disorders
Study type: Interventional

Summary: 
      The aim of the study was to compare the effectiveness of acute psychiatric day care to
      conventional inpatient care within a cross-national multi-site randomised controlled trial.
    


Intervention name(s): acute psychiatric day care
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Interplay of miRNA-146a and miRNA-126 in Chronic Periodontitis Patients With Coronary Artery Disease
Condition: Chronic Periodontitis; Coronary Artery Disease; miRNA
MeSH terms: Periodontitis; Chronic Periodontitis; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Observational

Summary: 
      The role of micro-RNAs in chronic periodontitis associated with CAD is still in an incipient
      stage needs to be explored further. The investigators attempt to quantify and compare the
      levels of micro-RNA 146a and micro-RNA 126 in subgingival as well as coronary plaque samples
      obtained from patients diagnosed with chronic periodontitis with and without coronary artery
      disease.
    

Detailed description: 
      The role of micro-RNAs in chronic periodontitis associated with CAD is still in an incipient
      stage needs to be explored further. The investigators attempt to quantify and compare the
      levels of micro-RNA 146a and micro-RNA 126 in subgingival as well as coronary plaque samples
      obtained from patients diagnosed with chronic periodontitis with and without coronary artery
      disease.

      Seventy-five participants were selected and grouped into 3 categories; 25 patients diagnosed
      with chronic periodontitis and coronary artery disease: CP + CAD group; 25 patients diagnosed
      with chronic periodontitis alone: CP group; and 25 systemically and periodontally healthy
      controls (HP). Demographic variables, periodontal parameters, cardiac parameters, blood
      pressure were obtained. miRNA-146a and miRNA126 levels were assessed in subgingival plaque
      (SP) samples from all the three groups. Within CP+CAD group, SP samples of CP+CADa were
      compared with coronary plaques samples (CP) of CP+CADb while the patient underwent CABG.
    

Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Male subjects within 30-70 years of age were selected for the study
      
Keywords: Chronic Periodontitis; coronary artery disease; microRNA 146a; microRNA 126; plaque samples; biomarkers
Pharmacodynamics and Pharmacokinetics of Empagliflozin and Torasemide in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to investigate the effect of BI 10773,
      hydrochlorothiazide and torasemide on changes in serum and urine electrolytes. Furthermore
      the pharmacodynamic and pharmacokinetic interactions between BI 10773 and diuretics should be
      assessed.
    


Intervention name(s): BI 10773; hydrochlorothiazide; torasemide; BI 10773; torasemide; BI 10773; hydrochlorothiazide
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): multiple oral doses; multiple oral doses; multiple oral doses; multiple oral doses; multiple oral doses; multiple oral doses; multiple oral doses
Intervention MeSH terms: Empagliflozin; Hydrochlorothiazide; Torsemide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Results of Middle-sized Posterior Malleolus Fractures: Fixed Versus Non-fixed
Condition: Ankle Fractures; Posterior Malleolus Fractures
MeSH terms: Fractures, Bone; Ankle Fractures
Study type: Interventional

Summary: 
      This study aims prospective randomized comparison of mid-term clinical outcomes of
      middle-sized posterior malleolus fractures with and without internal fixation.
    

Detailed description: 
      Although it has traditionally been accepted that posterior malleolar fractures involving less
      than 25 percent of the tibial plafond do not require operative fixation, this belief is now
      questioned. A number of studies have shown that the posterior malleolus contributes
      significantly to ankle stability. Many studies have also demonstrated that postoperative
      outcomes are better in patients who underwent posterior malleolar reduction and fixation.

      The aim of this prospective study is to show how internal fixation of the posterior
      malleolus, including middle-sized posterior malleolar fractures (10-25%), affects clinical
      outcomes and to discuss the factors that may lead to arthritis of the ankle joint. The groups
      will be randomized. The clinical and functional results of 40 patients who will be operated
      between 2015-2019 due to ankle fracture will be evaluated at short to mid-term (2-5 years).
      According to our hypothesis, internally fixed posterior malleolar fractures give better
      clinical and functional scores.
    

Intervention name(s): Internal fixation
Intervention type(s): Procedure
Intervention description(s): Fixation of posterior malleolus with either plate or screws.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ankle; fracture; posterior; malleolus; fixation
A Feasibility Study Designed to Assess the Efficacy of the ActiLady Device in Adult Female Subjects With Dysmenorrhea
Condition: Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional
Phase: Phase 1

Summary: 
      ActiLady refers is employing targeted pressure waves, with the goal of reducing the pain
      associated with menstruation (clinically known as dysmenorrhea).
    


Intervention name(s): Miniature Actilady device active; Miniature Actilady device not active
Intervention type(s): Device; Device
Intervention description(s): Devices: Targeted pressure waves are created by two kind of methods ActiLady).
The effect of the waves used will be examined by the use of a silicon tube or polyvinyl chloride (PVC) tube which is inserted into the vaginal cavity. The other end of the tube will be connected to an "off the shelf" pressure waves generator and controller.
Self manufactured device inserted into the vaginal cavity and creating subsound pressure waves.; Devices: Targeted pressure waves are created by two kind of methods ActiLady).
The effect of the waves used will be examined by the use of a silicon tube or polyvinyl chloride (PVC) tube which is inserted into the vaginal cavity. The other end of the tube will be connected to an "off the shelf" pressure waves generator and controller.
Self manufactured device inserted into the vaginal cavity and creating subsound pressure waves.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment