bioihbjkbjnl/mcl2 huggingface dataset:
Premedication for ERCP With Midazolam or Tramadol
Condition: Chronic Disease
MeSH terms: Chronic Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      OBJECTIVE:Purpose of this study is to set forth the sedative efficacy and effects on early
      period cognitive functions of two premedication drugs used for ERCP (Endoscopic retrograde
      cholangiopancreatography) METHODS:This randomized and double blind study was performed with
      forty (18-70 of age) ASA I-III risk group patients for who elective ERCP was planned.
      Cognitive functions of patients were determined by mini-mental test (MMT). 0.5 mg/kg
      midazolam or 1mg/kg tramadol drop was administered orally before intervention to patients who
      were randomly divided into two premedication groups.

      Vital signs,BIS (Bispectral index), mRSS (modified Ramsay Sedation scale), NRS (numeric
      rating scale ) was evaluated. If MMT (mini-mental test) was ≤ 23 at 60th minute it was
      considered as cognitive impairment. Recovery period, post-procedure state of cognitive
      function at 60th minute were recorded.
    

Detailed description: 
      The Outcome Measures are number of Participants with Adverse Events, and the incidence of
      Postoperative cognitive dysfunction assessed by MMT (mini-mental test) in first 60 minutes.
    

Intervention name(s): Tramadol; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): GROUP T; GROUP M
Other intervention name(s): CONTRAMAL; DORMICUM
Intervention MeSH terms: Midazolam; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: premedication; ERCP; midazolam; tramadol; cognitive
Artificial Intelligence in Colonic Polyp Detection
Condition: Polyp of Colon; Adenoma Colon; Gastrointestinal Neoplasms
MeSH terms: Adenoma; Gastrointestinal Neoplasms; Digestive System Neoplasms; Polyps; Colonic Polyps
Study type: Interventional

Summary: 
      A randomized, controlled study investigating the potential benefits of artificial
      intelligence (AI) in the detection of colonic polyps during outpatient colonoscopy.
      Randomization between the use of AI and no AI is performed before the study procedure.
    


Intervention name(s): Artificial intelligence; No Artificial Intelligence
Intervention type(s): Device; Device
Intervention description(s): Colonoscopy with the aid of artificial intelligence for the detection of colonic polyps; Colonoscopy without the aid of artificial intelligence for the detection of colonic polyps
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: colonoscopy; artificial intelligence
To Assess Safety and Effect of Olaparib on the Pharmacokinetics of Anastrozole, Letrozole & Tamoxifen, and Their Effect on Olaparib, in Patients With Advanced Solid Cancer
Condition: Solid Tumours
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label 2-part Phase I study in patients with advanced solid tumours. Part A of
      the study (mandatory) will assess the effect of olaparib on the pharmacokinetics (PK) of
      anastrozole, letrozole and tamoxifen and vice versa; Part B will allow patients (if eligible)
      continued access to olaparib after the PK phase and will provide additional safety data.
    


Intervention name(s): Olaparib; Tamoxifen; Anastrozole; Letrozole; Pharmacokinetic sampling
Intervention type(s): Drug; Drug; Drug; Drug; Procedure
Intervention description(s): 2 x 150mg tablets, twice daily Day 1-5, and Day 27 onwards (Cohort 1), Day 20 onwards (Cohort 2) or Day 39 onwards (Cohort 3); 60mg Tamoxifen once daily, Day 10 - Day 13; 20mg Tamoxifen once daily, Day 14 - Day 31; 1mg Anastrozole once daily Day 10 - Day 24; 2.5mg Letrozole once daily Day 10 - Day 43; Blood sampling over 12-24 hour period for pharmacokinetic analysis
Intervention MeSH terms: Tamoxifen; Letrozole; Olaparib; Anastrozole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: oncology, cancer, tumour, neoplasm, anticancer drug, pharmacokinetics, olaparib, anastrozole, tamoxifen, letrozole,
LEO 32731 - A Phase I Study in Healthy Subjects
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      LEO 32731 ("Study Drug") is an investigational drug which is being developed by LEO Pharma
      A/S ("the Sponsor") for treatment of psoriasis. The aim (s) of this Study are to determine:

        -  The safety and tolerability of the Study Drug and any side effects that might be
           associated with it

        -  The Study will also measure how much of the Study Drug that gets into the blood and how
           long time it takes for the body to remove it.
    


Intervention name(s): LEO32731; Placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Immunogenicity of Rabies Vaccine for Pre Exposure Prophylaxis
Condition: Rabies
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the effectiveness of a two dose versus a three dose
      schedule and intramuscular versus intradermal injection for pre-exposure prophylaxis.
    

Detailed description: 
      This is an exploratory vaccine trial to evaluate immunogenicity of a non-licensed dosing
      schedule and route of administration for a currently FDA licensed rabies vaccine for
      pre-exposure prophylaxis against rabies infection. The goal of this study is to characterize
      the immune response and persistence of immunity to a shortened dose schedule and intradermal
      (ID) administration, relative to the current licensed dosing schedule of the rabies vaccine
      (3 dose (0, 7, 21 days) IM). Rabies virus is endemic throughout the world due to high rates
      of both wild and domestic animal rabies and the risk to deployed military in endemic areas is
      considerable. Currently the commonly supported pre-exposure prophylaxis regimen for rabies,
      in the United States is comprised of three, 1.0 ml intramuscular (IM) injections of the human
      diploid cell vaccine (HDCV) or purified chick embryo cell (PCEC) rabies vaccine on days 0, 7,
      and 21 or 28. Modified, two and three dose schedules of intradermal (ID) injections of 0.1 ml
      of HDCV and PCEC are utilized outside the US. These two and three dose intradermal schedules
      share a similar safety and immunogenicity profile to intramuscular vaccinations and are
      easily boosted at one year after vaccination. A death, from rabies, of a US Soldier returned
      from Afghanistan underscores the importance of rabies pre-exposure prophylaxis for soldiers
      and the need to evaluate the safest, most effective means of vaccinating large deploying
      forces. While the current three dose, 1 ml IM rabies series is effective, a shortened,
      equally effective vaccination series with significantly smaller dose per injection would
      greatly improve the logistics and cost associated with universal or even targeted coverage of
      deploying soldiers. Evaluation of a shorter, smaller-dose, pre-exposure vaccination series
      for rabies is the goal of this study.
    

Intervention name(s): Rabies vaccine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Compare dose schedule and route of administration; Placebo
Other intervention name(s): Rabavert; Albumin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Diode Laser and SRP in Chronic Periodontitis
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      The purpose of this study is to compare the efficacy of photoablative and photodynamic diode
      laser in adjunct to scaling-root planing (PAPD+SRP) and SRP alone for the treatment of
      periodontitis.
    

Detailed description: 
      The present study is a randomized, blinded, controlled clinical trial, which used a
      split-mouth design. All patients were informed individually about the nature of the proposed
      treatment, and informed consent forms were signed. Twenty-four patients were studied.
      Maxillary left or right quadrants were randomly assigned to PAPD laser treatment or
      sham-treatment and SRP. PAPD consisted of: i) photoablative gingival epithelium with diode
      laser (λ 810 nm, 1 W); ii) photodynamic treatments (4-10 weekly) with diode laser (λ 635 nm,
      100 mW) and 0.3% methylene blue as photoactive antiseptic, performed after SRP.
      Sham-treatment was similar but with switched off laser.

      Efficacy evaluations, including probing depth (PD), clinical attachment level (CAL), bleeding
      on probing (BOP) was performed at baseline ,1year, and year 3 using a conventional manual
      periodontal probe. Polymorphonuclear leukocytes (PMN), erythrocytes (RBC), damaged epithelial
      cells (DEC) and bacteria were assayed by cytofluorescence on gingival exfoliative samples at
      baseline, 6 month and 1, 3, 5 years.
    

Intervention name(s): PAPD+SRP; Sham-laser +SRP
Intervention type(s): Procedure; Procedure
Intervention description(s): Photoablation of the gingival epithelium was performed with at 810 nm diode laser (1 W output power, continuous wave mode, 66.7 J/cm2, a 0.6 mm optical fiber). SRP was performed using curettes. The periodontal tissues and the dental root were rinsed with the photosensitizer agent methylene blue (0.3% w/v in water). After 5 min., the treated areas were irradiated with at 635 nm diode laser (100 mW output power, continuous wave mode, 0.6 mm optic fiber). The photodynamic treatment was repeated once weekly until normalization of the cytodiagnostic parameters (range: 4-10 applications).; Sham-treatment was similar to the previously described treatment but with switched off laser, followed by scaling and root planing
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Laser; periodontitis; scaling root planing; bacteria; PMN
High Definition Ultrasound Imaging of the Intermuscular Bridges at the Interscalene Groove
Condition: Healthy
Study type: Observational

Summary: 
      This study aims to define the intermuscular bridges between the scalene muscles at the
      interscalene groove (around neck area) using high definition US imaging in a cohort of
      volunteers.
    

Detailed description: 
      The Interscalene brachial plexus block (ISBPB), with recent techniques like phrenic nerve
      sparing interscalene approach, has better safety profile than before and because of this, it
      is often the technique of choice for anaesthesia and/or analgesia during shoulder and
      proximal arm surgery. Anatomical variations at the interscalene groove are not uncommon and
      few have been described in the literature. Understanding the anatomy of the brachial plexus
      and its sheath at the interscalene groove is vital for the success of the block and to reduce
      the risk of complications during ultrasound (US) guided ISBPB. Recently, with the use of high
      definition ultrasound, using high frequency linear transducer, the principal investigator
      have identified intermuscular bridges appearing between the ventral rami of the brachial
      plexus at the interscalene groove. These intermuscular bridges may affect the spread of local
      anesthetic dispersion within the brachial plexus sheath thereby affecting the block dynamics
      of ISBPB. Therefore, this prospective observational study aim to define the intermuscular
      bridges at the interscalene groove using high definition ultrasound imaging in a group of
      healthy volunteers.
    

Intervention name(s): Ultrasound scan
Intervention type(s): Other
Intervention description(s): Volunteers will have an ultrasound scanning of both sides of their neck lying in supine position. Sequentially the scanning will start from the base of the neck (supraclavicular fossa) to the upper part of the interscalene groove and then in the reverse direction to the supraclavicular fossa. Images will be recorded as video loops.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult volunteers among staff, residents and their friends
      
Keywords: interscalene groove; intermuscular bridges
Decompressive Cervical Surgery and Hypertension
Condition: Myelopathy, Compressive; Hypertension
MeSH terms: Spinal Cord Diseases; Spinal Cord Compression; Hypertension
Study type: Observational

Summary: 
      There is a relationship between CSM and hypertension, probably a cause/effect relationship,
      and investigators term this type of hypertension "cervicogenic hypertension". Abnormally
      functioning serotonergic pacemaker cells in the dorsal raphe nucleus inappropriately activate
      and inhibit parts of the central and autonomic nervous systems as part of a chronic stress
      response, which causes hypertension and migraine. This theory is now being expanded to
      encompass both CSM and essential hypertension, the idea being that these two conditions are
      intimately related.
    

Detailed description: 
      Cervical spondylotic myelopathy (CSM) and hypertension are both very common diseases in the
      general population.Investigators have also observed previously hypertensive patients with CSM
      become normotensive following decompressive cervical surgery and no longer need
      antihypertensive medications. Both observations are difficult to explain according to current
      theories of the two diseases.
    

Intervention name(s): decompressive cervical surgery
Intervention type(s): Procedure
Intervention description(s): To make decompressive cervical surgery, either anterior cervical discectomy and fusion or posterior laminoplasty on the patients suffering from cervical spondylotic myelopathy and hypertension.
Other intervention name(s): anterior cervical discectomy fusion; posterior laminoplasty
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients at our Spine Center suffering signs and symptoms of cervical myelopathy and with
        evidence of radiographic cervical cord compression with hypertension.
A Study to Evaluate the Safety and Efficacy of Obinutuzumab Compared With Placebo in Participants With Lupus Nephritis (LN)
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase II study will compare the efficacy and safety of obinutuzumab plus mycophenolate
      mofetil (MMF)/mycophenolic acid (MPA) with placebo plus MMF/MPA in participants with
      proliferative LN.
    


Intervention name(s): Mycophenolate Mofetil/Mycophenolic Acid; Obinutuzumab; Placebo; Methylprednisolone; Prednisone
Intervention type(s): Drug; Drug; Other; Drug; Drug
Intervention description(s): MMF/MPA will be administered as per schedule specified in the respective arm.; Obinutuzumab will be administered as per schedule specified in the respective arm.; Placebo matching to obinutuzumab will be administered as per schedule specified in the respective arm.; Methylprednisolone IV will be administered as per schedule specified in the respective arm.; Prednisone will be administered as per schedule specified in the respective arm.
Other intervention name(s): Gazyva, GA101, RO5072759
Intervention MeSH terms: Mycophenolic Acid; Prednisone; Methylprednisolone; Obinutuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of the Use of BATHE Interview Technique on Treatment Compliance in Hypertension Patients in Primary Care
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional

Summary: 
      The research is planned to evaluate the treatment compliance after the BATHE interview
      technique in hypertension patients.
    

Detailed description: 
      In order to be evaluated for suitability for the study, patients aged 18-80 who have been
      diagnosed with hypertension for at least 6 months (n= 220) were interviewed and 86
      hypertension patients who met the inclusion criteria and volunteered for the study were
      included in the study. Participants whose eligibility was determined as a result of the
      evaluation in terms of inclusion and exclusion criteria were asked about their volunteerism
      in the intervention study, their written consent was obtained from those who volunteered, and
      those who volunteered were randomized.
    

Intervention name(s): BATHE
Intervention type(s): Behavioral
Intervention description(s): The BATHE interview technique was applied 3 times, once every 3 months, for 6 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: single-blind, parallel-group, randomized-controlled intervention study
Masking: Single (Participant)
Primary purpose: Other
A Study to Evaluate the Safety and Effect of Co-administration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Virus Diseases; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of co-administration of
      ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as
      ombitasvir) in adults with chronic hepatitis C virus infection.
    

Detailed description: 
      This was a Phase 2, randomized, open-label, combination treatment study of the 2-DAA regimen
      (ABT-450 150 mg QD + ritonavir 100 mg QD + ABT-267 25 mg QD) in adult HCV GT1b-infected
      treatment-naïve and Pegylated-interferon/ribavirin (pegIFN/RBV) treatment-experienced
      participants without cirrhosis and with compensated cirrhosis, and in adult GT4-infected
      treatment-naïve and pegIFN/RBV treatment-experienced participants without cirrhosis.
      Treatment Group 5 was not open to enrollment, based on a protocol-specified interim review of
      results from the treatment-naïve GT4 Groups 1 and 4 that indicated higher sustained virologic
      response (SVR) rates among participants receiving the 2-DAA regimen with RBV. All other
      groups completed the study.
    

Intervention name(s): ABT-450/r; ABT-267; Ribavirin (RBV)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablet; ABT-450; Capsule; ritonavir; Tablet; Tablet
Other intervention name(s): ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C Virus; Ribavirin-Free; Hepatitis C Genotype 1; Hepatitis C; Interferon-Free; Chronic Hepatitis C; Compensated cirrhosis; Hepatitis C Genotype 4; Paritaprevir; Ombitasvir; Ritonavir; Ribavirin
Eccentric Strength Training of Ankle Joint Muscles in Swimming
Condition: Resistance Training
Study type: Interventional

Summary: 
      This study was conducted to investigate the effectiveness of ankle muscle strengthening
      program of 8 weeks on the underwater dolphin kick performance in young swimmers. This study
      was a randomized controlled trial. Swimmers was divided in two groups; eccentric ankle
      muscle-strengthening exercises and control group. The outcome measures were strength of
      plantar flexors, dorsal flexors, internal rotators, external rotators and 5-meter underwater
      dolphin kick time.
    

Detailed description: 
      There is limited information on the effectiveness of ankle joint muscles in respect to the
      knee, hip, back and upper extremity muscles creating the propulsive forces for the feet to
      transfer the moment force towards water. Therefore, it is aimed to observe the effects of
      eccentric ankle muscle-strengthening exercises given by means of elastic bands on the
      Underwater Dolphin Kick performance of young swimmers.
    

Intervention name(s): Eccentric exercise
Intervention type(s): Other
Intervention description(s): progressive eccentric exercise with elastic band
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In order to examine the effect of strengthening exercises on performance amongst competitive young swimmers, a randomized controlled trial was undertaken. Swimmers were divided into two groups: Exercise (n=13) and the control groups (n=13). Both groups were assessed for 5-metre underwater swim time and ankle muscle strength before and after 8 weeks of normal swimming training. The exercise group received eccentric ankle strengthening exercises with an elastic band, in addition to their regular swimming training. Participants completed 24 exercises over 8 weeks, with 3 non-consecutive training sessions per week. Dynamic (2 minutes) and static stretching (2 minutes) exercises were performed as before the training session.
Masking: None (Open Label)
Primary purpose: Other
Keywords: swimming; resistance training; youth sports; elastic band; ankle
Effectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma in Argentina
Condition: Advanced Hormone Dependent Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational [Patient Registry]

Summary: 
      Prospective, observational study to collect and analyze data on patients with advanced
      hormone dependent prostate cancer treated with Firmagon® according to routine medical
      practice in Argentina
    


Intervention name(s): Firmagon® (degarelix)
Intervention type(s): Drug
Intervention description(s): Monthly subcutaneous injections
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        200 patients with Advanced Prostate Cancer that receive Firmagon therapy in the context of
        usual clinical practice
Early Detection of Anaemia During the Maternity
Condition: Anemia
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 3

Summary: 
      Estimate the efficiency of a strategy of premature screening of the maternal anaemia during
      the first quarter of pregnancy versus the usual strategy of screening of the anaemia during
      the sixth month.
    

Detailed description: 
      A part of the patient will have a NFS and dosage of the cast-iron, during the results of the
      beginning of the pregnancy at the first quarter.

      The other part of the patients will have a NFS and at the first quater of the pregnancy.

      All the patient will have a NFS at the results of the sixth month of the pregnancy.

      A NFS will be done during the results at the end of the pregnancy like we do now.

      Then a NFS at 48 hours after the birth. A treatment with iron will be done and according to
      the results
    

Intervention name(s): dosage of the NFS and iron
Intervention type(s): Biological
Intervention description(s): a blood test will be made.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: aneamia; aneamia during the maternity