bioihbjkbjnl/mcl2 huggingface dataset:
Tramadol and Pain Sensitization
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      Tramadol is a largely used analgesic drug. Its role however on sensitization as occurs for
      example in neuropathic pain is not very well known. This protocol aims therefore at studying
      the effect of tramadol in a human pain model with sensitization induced by a cold stimulus,
      using evoked potentials to elucidate how pain is modified when tramadol is administered.
    

Detailed description: 
      The study is a comparison of the analgesic of tramadol versus placebo in a pain model using
      evoked potentials. Evaluation criteria will be the amplitude of the evoked potential obtained
      defore and after treatment
    

Intervention name(s): Tramadol
Intervention type(s): Drug
Intervention description(s): to compare of the analgesic of tramadol versus placebo in a pain model using evoked potentials
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pain; sensitization; analgesia; Healthy volunteers and pain
A Case Series of VPIA Using Remifentanil for Labour and Delivery
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Observational

Summary: 
      This study is a prospective case series aiming to evaluate a new VPIA remifentanil algorithm
      which would benefit labouring mothers who are unable or unwilling to receive epidural
      analgesia.
    

Detailed description: 
      This study proposes a novel Vital signs-controlled, patient-assisted intravenous analgesia
      (VPIA) regimen that will enhance the efficacy, safety and personalization of remifentanil
      therapy for labouring women. This system will study the parturient's pattern of analgesic use
      in 15 min epochs and titrate the demand doses and basal infusion rate to maintain a plasma
      level of remifentanil that is appropriate for the degree of pain felt.

      The system incorporates vital signs (pulse oximetry and heart rate values) into the algorithm
      which would temporarily stop the pumps and step down doses accordingly when predefined
      critical values are reached.
    

Intervention name(s): VPIA remifentanil
Intervention type(s): Device
Intervention description(s): Vital signs controlled patient assisted intravenous analgesia using remifentanil
Intervention MeSH terms: Remifentanil
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Term parturients presenting to the hospital delivery suite in labour
      
Keywords: Remifentanil; Labour analgesia
The Effect of Breastfeeding Pillow on Breastfeeding Self-Efficacy and Postpartum Comfort in Women Who Had Cesarean
Condition: Cesarean Section; Dehiscence; First Birth
Study type: Interventional

Summary: 
      The research is a randomised controlled experimental study. It was conducted to examine the
      effect of breastfeeding pillow on breastfeeding self-efficacy and postnatal comfort in
      primiparous puerperas who gave birth by caesarean section. The answers to the questions "Is
      the breastfeeding pillow effective on breastfeeding self-efficacy in primiparous puerperium
      giving birth by caesarean section?" and "Is the breastfeeding pillow effective on comfort
      during breastfeeding in primiparous puerperium giving birth by caesarean section?" are
      investigated. The puerperas in the experimental group were allowed to use a breastfeeding
      pillow during breastfeeding and evaluated at 24th and 48th hours. Puerperas in the control
      group continued routine breastfeeding and did not use a breastfeeding pillow. They were
      evaluated at 24th and 48th hours.
    


Intervention name(s): using a breastfeeding pillow; not using a breastfeeding pillow
Intervention type(s): Other; Other
Intervention description(s): To make the breastfeeding pillow group use the breastfeeding pillow from the 8th hour in the postnatal period and to make evaluations at 24 and 48 hours; The non-breastfeeding pillow group was evaluated at 24 and 48 hours without the use of a breastfeeding pillow
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Quantitative
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Breastfeeding; Exclusive Breast Milk; Patient Comfort; Self-efficacy
Multimodal Neuroimaging of Stress and Reward Cues to Assess Alcoholism Risk and Relapse
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      Extending previous findings, and applying a novel multi-method translational approach, this
      project hypothesizes that there are alcohol-related neuroendocrine and neural changes
      observable in acute and protracted abstinence, and which can accurately classify future
      relapse and treatment outcome in separate alcohol dependent (AD) patient samples, thereby
      validating them as biomarkers of relapse, with potential clinical utility as prognostic
      markers in identifying and treating those most susceptible to relapse.
    


Intervention name(s): Multi-method Neuroendocrine and Neuroimaging Procedure Scan 1; Multi-method Neuroendocrine and Neuroimaging Procedure Scan 2
Intervention type(s): Device; Device
Intervention description(s): The MRI scan will be conducted on a 3-T Siemens Trio MRI system equipped with a standard quadrature head coil, using T1 MPRAGE sequence for structural scanning and T2*-sensitive gradient-recalled single shot echo planar pulse sequence for functional scans. Two multimethod MRI scans will be conducted in the AD sample, while the controls will participate in a single scan.; The MRI scan will be conducted on a 3-T Siemens Trio MRI system equipped with a standard quadrature head coil, using T1 MPRAGE sequence for structural scanning and T2*-sensitive gradient-recalled single shot echo planar pulse sequence for functional scans. Two multimethod MRI scans will be conducted in the AD sample, while the controls will participate in a single scan.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
PDE-4 Inhibitor Roflumilast and GLP-1 Agonist Liraglutide in Polycystic Ovary Syndrome
Condition: PCOS; Obesity
MeSH terms: Polycystic Ovary Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to determine whether monotherapy treatment with
      phosphodiesterase-4 (PDE-4) inhibitor roflumilast is more effective than treatment with
      glucagon-like protein 1 (GLP-1) liraglutide or treatment with metformin as monotherapy in the
      treatment of obese women with polycystic ovary syndrome (PCOS) regarding weight reduction who
      have not been treated before. The investigators anticipated greater changes in body weight in
      patients on roflumilast treatment than in liraglutide or metformin.
    


Intervention name(s): metformin; liraglutide; roflumilast
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Glucophage tablets; Victoza injection; Daxas 500 micrograms film-coated tablets
Intervention MeSH terms: Metformin; Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PCOS; PDE-4 inhibitor; roflumilast; liraglutide; metformin; obesity
Precise Treatment of Prediabetes and Stage 1 Hypertension
Condition: Diabetes
MeSH terms: Hypertension; Prediabetic State
Study type: Observational

Summary: 
      To identify the occurrence of diabetes, hypertension, cardiovascular and cerebrovascular
      events and all-cause death in patients with baseline prediabetes and stage1 hypertension
      after 18 years follow up. To identify whether one or several metabolites can be used as serum
      markers to judge the prognosis of patients with prediabetes and stage1 hypertension, and to
      establish the evaluation model of metabolites for the prognosis.
    

Detailed description: 
      To identify the occurrence of diabetes, hypertension, cardiovascular and cerebrovascular
      events and all-cause death in patients with baseline prediabetes and stage1 hypertension
      after18 years follow up, then explore the role of risk factors. After assessing the
      association between BP categories and all-cause mortality and cardiovascular mortality, to
      analyze the risk for all-cause and cardiovascular mortality by blood glucose categories and
      BP categories combined by using multiple Cox regression analysis. To analyze the
      corresponding incidence of all-cause mortality per 1,000 person-years for the BP<130/80 mmHg,
      130-139/80-89 mmHg, and ≥140/90 mmHg or treated groups respectively after adjusting for age,
      sex, and other factors. To identify the associations between cardiovascular mortality and BP
      categories alone or combined with blood glucose categories were consistent with that of
      all-cause mortality.

      To identify relative metabolic molecular biomarker panel detected by mass spectrometry in
      blood samples correlating with efficacy in prediabetes and stage 1 hypertension among Chinese
      adults. Compare the plasma metabolic profiles of different groups and the metabolic markers
      were screened and optimized by multivariate statistical analysis, logistic regression
      analysis and receiver operating characteristic (ROC) curve analysis.

      To determine whether one or several metabolites can be used as serum markers to judge the
      prognosis of patients with prediabetes and stage1 hypertension, and to establish the
      evaluation model of metabolites for the prognosis.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Male and female participants ages 18-76 years from the Pingliang community was conducted
        from November 2002 to January 2003. At baseline, all participants underwent physical
        examination and were interviewed with standardized questionnaires.
      
Biospecimen description: 
      10 ml serum and plasma
    
Keywords: 130-139/80-89 mmHg; all-cause mortality; cardiovascular mortality; glucose metabolism; Chinese
Relative Bioavailability of BI 10773 Administered Twice Daily Compared BI 10773 Given Once Daily After Multiple Oral Doses in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the influence of different dosage regimen (5 mg twice daily versus 10 mg once
      daily) on the steady state pharmacokinetics and pharmacodynamics of BI 10773 administered
      orally
    


Intervention name(s): Empagliflozin; Empagliflozin
Intervention type(s): Drug; Drug
Intervention description(s): 5 days of treatment with 5 mg BI 10773 bid until steady state; 5 days of treatment with 10 mg BI 10773 qd until steady state
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Differences in Urine NGAL Levels in Patients Undergoing RIRS With or Without Ureteral Access Sheath
Condition: Urolithiasis
MeSH terms: Urolithiasis
Study type: Interventional

Summary: 
      This study will include patients aged between 18 and 65 who will undergo retrograde
      infrarenal surgery (RIRS) due to renal stone(s). A total of 60 patients (male or female) will
      be recruited, and will be randomized into 2 groups consisting of 30 patients in each group.
      The first group of patients will undergo RIRS with a ureteral access sheath (UAS) positioned
      prior to surgery; and the second group will undergo RIRS without UAS. As use of UAS decreases
      the pressure in the renal pelvis during RIRS, it is aimed to evaluate whether using UAS or
      not affects the kidney functions. besides the routine kidney function tests, namely urea and
      creatinine, neutrophil gelatinase-associated lipocalin (NGAL) (a more specific and early
      marker of kidney function) will be used to assess the differences in the kidney functions.
      Preoperative blood urea and creatinine levels and urine NGAL levels will be studied for all
      patients. After the surgery, blood urea and creatinine levels will be again studied as well
      as urine NGAL levels at postoperative 2nd hour, 72nd hour and 1st week.
    


Intervention name(s): RIRS with ureteral access sheath; RIRS without ureteral access sheath
Intervention type(s): Device; Device
Intervention description(s): Ureteral access sheath will be used during RIRS.; Ureteral access sheath will not be used during RIRS.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: kidney; kidney stone; NGAL; ureterorenoscopy; intrarenal surgery; kidney function
Characterization of LV Strain Patterns in Mildly Elevated PCWP and PAH.
Condition: Hypertension, Pulmonary Artery; Ventricular Dysfunction, Left
MeSH terms: Hypertension, Pulmonary; Hypertension; Ventricular Dysfunction; Ventricular Dysfunction, Left; Sprains and Strains
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if patients with pulmonary hypertension and mildly
      elevated heart pressure known as PCWP will exhibit different patterns on echocardiography and
      that these patterns will predict treatment response to sildenafil, a drug given for this
      condition.
    


Intervention name(s): sildenafil
Intervention type(s): Drug
Intervention description(s): Subjects will be started on sildenafil at 20 mg PO TID at the baseline visit. Each individual will serve as his/her own control. Subjects will be evaluated at 3 months, with participation completed at that time.
Other intervention name(s): Revatio; compound UK-92,480; Patent 5,250,534; sildenafil citrate; NDA 22-473; C22H30N6O4S.C6H8O7; C28H38N6O11S
Intervention MeSH terms: Sildenafil Citrate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Pulmonary Artery Hypertension; pulmonary capillary wedge pressure; sildenafil; echocardiography; left ventricular longitudinal wall strain; strain rate pre and post medical therapy; speckle tracking
Effects of a Comprehensive Intervention on Blood Pressure Control in a Primary Care Setting
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The implementation of lifestyle modifications, home blood pressure (BP) measurement, and
      optimization of antihypertensive drug therapy have been shown to improve BP control in
      tightly controlled research settings. The investigators objective is to determine the effect
      of these interventions in a primary care setting, with the family practitioners and nurses
      serving as the interventionists. The investigaotrs hypothesis is that a comprehensive
      intervention performed in a primary care setting would lead to better blood pressure control.
    


Intervention name(s): Intensive Care
Intervention type(s): Other
Intervention description(s): Comprehensive intervention on hypertension through optimization of drug therapy, introduction of home blood pressure monitoring, and lifestyle guidance
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Periodontally Accelerated Osteogenic Orthodontics With BMP2
Condition: Malocclusion
MeSH terms: Malocclusion
Study type: Interventional
Phase: Phase 2

Summary: 
      rhBMP-2 has the potential to function as a regenerative material in periodontally accelerated
      osteogenic orthodontics (PAOO). This study aimed to assess the effects of PAOO with BMP-2 on
      outcomes such as treatment period, bone density, healing and pain.
    

Detailed description: 
      Subjects were randomly assigned into each of the following experimental groups; C+BMP:
      corticotomy with 0.5 μg/mL rhBMP-2 and C: corticotomy only. Clinical parameters included
      recording the duration of treatment period, visual analogue scale (VAS) scores and early
      healing index (EHI) scores. The evaluation of bone density was performed at baseline, 3
      months and 6 months by using RVG.
    

Intervention name(s): RhBMP-2 Protein, Recombinant; Conventional Corticotomy
Intervention type(s): Drug; Other
Intervention description(s): Bone morphogenetic proteins (BMPs) are a category of proteins that are involved in bone formation and repair. Among these, BMP-2 is one of the most potent members of the BMP family and has been used for correcting intrabony, supraalveolar, furcation, and fenestration defects due to its osteoinductive property. BMP's are also essential for differentiation of osteoclasts, but their role in this process remains unclear. Treatment of osteoclasts with exogenous BMP-2 directly enhances RANKL-stimulated differentiation of osteoclast precursors in vitro and stimulates survival and resorptive activity of mature osteoclasts that accelerates the tooth movement.; A conventional PAOO Surgical procedure will be performed for individuals in this arm
Other intervention name(s): Osteogenic protein; PAOO Surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is a randomized controlled clinical trial where systemically healthy individuals undergoing orthodontic therapy and willing to participate in the study were referred from the Department of Orthodontics and were followed up over a 6 month period after treatment.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Pulpotomy With Various MTA Materials and Ferric Sulphate
Condition: Pulpotomy
Study type: Interventional

Summary: 
      The aim of this study was to determine clinical and radiographic efficacy of the newly
      developed OrthoMTA and RetroMTA , compared frequently used ferric sulfate for pulpotomy in
      primary second molars.
    

Detailed description: 
      A total of 96 second primary second molars from 32 children ,who met inclusion criteria and
      were 5-9 years old were selected for the study. Teeth were randomly divided into three groups
      according to the planned treatment: O-MTA (n=32 teeth), R-MTA (n=32 teeth) and FS (n=32
      teeth). Clinical and radiographical follow-up examinations were conducted at 3, 6 and 9
      months postoperatively. The data were evaluated with Chi-square test, Cochran Q test,
      Post-Huc Dunn test and Kaplan-Meier analysis.
    

Intervention name(s): Ferric sulphate; Ortho-MTA; Retro-MTA
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Teeth were pulpotomized with ferric sulphate in this group.; Teeth were pulpotomized with Ortho-MTA in this group.; Teeth were pulpotomized with Retro-MTA in this group.
Intervention MeSH terms: Pemetrexed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: pulpotomy
Effect of Vacuum on Fetal and Maternal Complications During Difficult Caesarean Section
Condition: Complications; Cesarean Section
Study type: Interventional
Phase: Phase 3

Summary: 
      The Cesarean Section (C/S) rate from 1970 to 2007 in U.S is 31.8% and in Iran From 2000 to
      2009 rose to 50-65%. This Surgical Procedure is not without risk. Difficult head Extraction
      in C/S occur in 1-2% of all deliveries. This study was designed to compare the results of
      delivery by vacuum in C/S with normal caesarean section.
    


Intervention name(s): vacuum; routine manual maneuvers for fetal head extraction
Intervention type(s): Procedure; Procedure
Intervention description(s): Vacuum is an instrument that is using for helping delivery when there is no possibility of spontaneous delivery. First report of using vacuum was in 1962 by Solomon for delivery of fetal head (12). He suggested that using this instrument will lower pressure on fetal head and decrease delivery time (and then decrease fetal hypoxemia). Also it decreases spreading of incision and vascular injury (during manual maneuvers). Some studies confirmed these results (13, 14) and some others disagreed it (15, 16).
Considering with importance of fetal head delivery in a short time during C/S and to decrease maternal complications like lacerations and vascular injuries, this study was designed to compare the results of delivery by vacuum in C/S with routine methods for head extraction during difficult caesarean sections.; fetal head techniques like fundal pushing, pulling technique or reverse breech extraction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: caesarean section,; vacuum,; fetal head extraction,; maternal complication,; fetal complication
Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects
Condition: Healthy Male Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the pharmacokinetic characteristics of Lodivixx tab.5/160mg in healthy male
      subjects

        -  PK parameter evaluation

        -  Safety profile evaluation
    


Intervention name(s): Exforge tab. 10/160mg; Lodivixx tab. 5/160mg
Intervention type(s): Drug; Drug
Other intervention name(s): - amlodipine besylate; - valsartan; - S-amlodipine; - valsartan
Intervention MeSH terms: Amlodipine; Valsartan; Amlodipine, Valsartan Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Phase II Clinical Trial of Safety and Immunogenicity of Recombinant Subunit Tuberculosis Vaccine GamTBvac
Condition: Healthy
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a double-blind, randomized (in 3:1 ratio -vaccine : placebo) study to assess the
      safety, reactogenicity and immunogenicity in healthy, BCG vaccinated adults.
    

Detailed description: 
      Participants will be randomized in two groups (in 3:1 ratio -vaccine : placebo) to receive
      two doses of either GamTBvac or placebo. Subjects will be followed for 5 months after dose 1.

      The primary goal of this study is to assess the immunogenicity of a tuberculosis subunit
      recombinant GamTBvac vaccine in a vaccination scheme with double administration to healthy
      volunteers.

      The secondary goal of this study is the in-depth assessment of the safety and reactogenicity
      of the tuberculosis subunit recombinant vaccine GamTBvac when given twice to healthy
      volunteers.
    

Intervention name(s): GamTBvac vaccine; placebo
Intervention type(s): Biological; Biological
Intervention description(s): introduction of GamTBvac (lyophilisate for preparation of solution for subcutaneous administration, 5.35 mg / dose) twice into a shoulder with an 8-week interval.; introduction of placebo twice into a shoulder with an 8-week interval.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a double-blind, randomized (in 3:1 ratio -vaccine : placebo) study
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Tuberculosis; Mycobacterium tuberculosis; Recombinant vaccine; Mycobacterium Infections; Vaccines