bioihbjkbjnl/mcl2 huggingface dataset:
Analgesic Effects of rTMS in Peripheral Neuropathic Pain
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional

Summary: 
      This study aims to evaluate the long term efficacy over 25 weeks of repeated sessions of
      magnetic transcranial stimulation of the motor cortex or prefrontal cortex on average pain
      intensity, quality of life, sleep, neuropathic symptoms, return to work, in patients with
      peripheral neuropathic pain.

      The medical device of study: transcranial magnetic stimulator (TMS).
    

Detailed description: 
      The present multicenter parallel session randomized placebo controlled study (4 French
      centers) aims to evaluate the long term efficacy over 25 weeks of repeated sessions of
      magnetic transcranial stimulation of the motor cortex or prefrontal cortex on average pain
      intensity (primary outcome) and several secondary outcome measures (e.g. quality of life,
      sleep, neuropathic symptoms, return to work), in patients with peripheral neuropathic pain.

      The patients will be randomized to receive one of 3 treatment arms : rTMS of the motor
      cortex, rTMS of the prefrontal cortex, or placebo (sham stimulation) of the motor or
      prefrontal cortex. The study will be double blind, eg the patient and the investigator will
      not know the nature of treatment. the stimulation protocol will consist of an induction
      phasse of 5 daily sessions then a maintenance phase of several sessions : 3 sessions a week
      apart, 3 sessions a fortnight apart, and 3 sessions 3 weeks apart. The statistical analysis
      will be conducted in the intent to treat population and using a modified ITT analysis
      excluding all the patients with protocol violation (primary outcome). The per protocol
      population will also be assessed.
    

Intervention name(s): rTMS of prefrontal or motor cortex
Intervention type(s): Device
Intervention description(s): description:rTMS of the motor or prefrontal cortex (repetitive magnetic stimulation targeting the motor or prefrontal cortex) assisted with neuronavigation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rTMS; peripheral neuropathic pain; randomized controlled trial
New Technique for Uretero-ileal Anastomosis for Patient With Bladder Cancer Who Are Suitable for Orthotopic Neobladder
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional

Summary: 
      there are many techniques for uretero-ileal anastomosis some of them are antirefluxing for
      protection of the upper urinary tract with many complications including strictures and
      pyelonephritis with difficult technical issues and long operation time so a modified
      technique combining the 2 ureter by wallace technique and implanted them in a single trough
      in the neobladder making the surgery easier and shorter.

      this technique was done after informed consent in 45 patients with muscle invasive bladder
      cancer candidate for radical cystectomy and ileal neobladder diversion
    

Detailed description: 
      This was a prospective study conducted from 2014 to 2017 in Ain shams university, 73 patients
      were enrolled from outpatient clinic diagnosed with muscle invasive bladder cancer and
      candidate for radical cystectomy and orthotopic urinary diversion, 45 patients were included
      according to patient's acceptance and the inclusion and exclusion criteria.

      After having a written informed consent, all selected patients were assessed by detailed
      history and physical examination, contrast enhanced pelvi-abdominal Computed tomography (CT)
      scan (for patients with serum creatinine <1.5 mg/dl). Laboratory investigations in the form
      of complete blood count, coagulation profile, electrolytes, renal and liver function tests.
      Bowel preparation was done to all patients one or two days before operation.

      Cases were diverted using a U-shaped pouch with uretero-ileal anastomosis done in a single
      trough combining the extramural serous-lined tunnel and Wallace techniques.
    

Intervention name(s): uretero ileal anastomosis in single trough
Intervention type(s): Procedure
Other intervention name(s): combining wallace and subserous tunnel in uretero ileal anastomosis
Intervention model: Single Group Assignment
Intervention model description: the new technique was observed in a group of patients for effectiveness and complications.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bladder Cancer; Orthotopic diversion; Wallace; sub-serous extramural tunnel.
Safety and Efficacy of the BTL-785F Device for Non-invasive Reduction of Wrinkles
Condition: Wrinkle
Study type: Interventional

Summary: 
      This study will evaluate the clinical safety and the performance of the BTL-785F system for
      non-invasive treatment of facial wrinkles. The study is a multicenter single-arm, open-label,
      interventional study. The subjects will be enrolled and assigned into one experimental study
      arm. The subjects will be required to complete four (4) treatment visits and two follow-up
      visits.
    


Intervention name(s): BTL-785F
Intervention type(s): Device
Intervention description(s): Radiofrequency
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study Evaluating Effects of Multiple-Dose Administration of Itraconazole on the Single Dose Pharmacokinetics of Conjugated Estrogens/Bazedoxifene in Non-Obese and Obese Postmenopausal Women
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess if itraconazole will affect the blood levels of Duavee when they are
      given together. This study will also assess if a subject's body size affects the blood levels
      of Duavee.
    


Intervention name(s): CE/BZA; Itraconazole; CE/BZA; CE/BZA; Itraconazole; CE/BZA
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): CE 0.45mg/BZA 20mg tablets, single dose; Two 100 mg capsules, once daily for 7 days; CE 0.45mg/BZA 20mg tablets, single dose on Day 5; CE 0.45mg/BZA 20mg tablets, single dose; Two 100 mg capsules, once daily for 7 days; CE 0.45mg/BZA 20mg tablets, single dose on Day 5
Other intervention name(s): Duavee; Sporanox; Duavee; Duavee; Sporanox; Duavee
Intervention MeSH terms: Itraconazole; Hydroxyitraconazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Postmenopausal Women; Obese; Non-obese; Drug Interaction with Itraconazole; Pharmacokinetic
The Validity of Retinal Blood Flow Measurements During Hyperoxia in Humans Using Fourier Domain Color Doppler Optical Coherence Tomography (CDOCT)
Condition: Healthy
MeSH terms: Hyperoxia
Study type: Interventional

Summary: 
      Noninvasive monitoring of blood flow in retinal circulation may elucidate the progression and
      treatment of ocular disorders, including diabetic retinopathy, age-related macular
      degeneration and glaucoma.

      Laser Doppler velocimetry (LDV), a noninvasive optical method combined with vessel size
      determination has been used extensively as a valuable research tool to examine blood flow
      dynamics in the human retina. However, no information on the velocity profile within the
      vessel is available. Ophthalmic color Doppler optical coherence tomography (CDOCT) provides
      laser Doppler information in addition to conventional optical coherence tomography, allowing
      the observation of blood flow dynamics simultaneously to imaging retinal structure.

      We have recently demonstrated the feasibility of Fourier domain CDOCT to assess velocity
      profiles in human retinal vessels in vivo.

      In the present study the validity of Fourier domain CDOCT for retinal blood flow measurements
      will be tested at baseline and during hyperoxia-induced vasoconstriction in humans by
      comparison with retinal blood flow measurements using a commercially available LDV system and
      the Zeiss retinal vessel analyzer (RVA)
    


Intervention name(s): 100% Oxygen
Intervention type(s): Other
Intervention description(s): 100% Oxygen- breathing over 30 minutes
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Regional Blood Flow; Color Doppler Optical Coherence Tomography; CDOCT; Retinal Blood Flow; Hyperoxia; Vasoconstriction; Laser Doppler Velocimetry; Retinal Vessel Analyzer
Comparison of Two Volar Plating Systems for Distal Radius Fractures
Condition: Distal Radius Fracture
MeSH terms: Fractures, Bone; Radius Fractures; Wrist Fractures
Study type: Interventional

Summary: 
      We plan to compare 2 types of plating systems for volar plating of distal radius fractures
      (Aptus 2.5® Medartis AG, Basel, Switzerland vs. INTEOS 2.5® - Hofer Medical GmbH and Co KG,
      Austria) in a prospective single-blinded controlled clinical trial.
    

Detailed description: 
      This study represents a prospective randomized clinical trial comparing two different systems
      of volar plate osteosynthesis in patients with distal radius fractures.

      Patients meeting the inclusion criteria will be enrolled in the present study provided they
      give their consent. Informed written consent will be obtained. Envelopes will be prepared
      containing equal number of cards representing either the conventional or the novel plating
      syste. On the morning of the surgery a randomly picked envelope decides allocation one of the
      study groups. Patients will be blinded to treatment until completion of the study. Patients
      allocated to the control group receive Aptus 2.5® volar plate for distal radius fractures
      (Medartis AG, Basel, Switzerland), while patients in the study group will receive the plating
      system INTEOS 2.5® (Hofer GmbH and Co KG, Austria). In the control group, the pronator
      quadratus muscle will be cut prior mounting of the plate, while in the treatment group the
      plate will be inserted underneath the pronator quadratus leaving the muscle intact.
    

Intervention name(s): Volar Plate Osteosynthesis Aptus 2.5; Volar Plate Osteosynthesis Inteos 2.5
Intervention type(s): Procedure; Procedure
Intervention description(s): Volar plating of distal radius fracture. Device: Aptus 2.5; Volar plating of distal radius fracture. Device: Inteos 2.5
Other intervention name(s): Henry approach, cutting of pronator quadratus; Henry approach, preservation of pronator quadratus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Acupuncture and Post-Operative Ileus
Condition: Ileus
MeSH terms: Ileus
Study type: Interventional

Summary: 
      Postoperative ileus, the transient cessation of normal bowel function, is a universal aspect
      of colon surgery. Its occurrence may lead to increased patient discomfort and additional time
      and cost to hospital stay. Evidence from previous studies indicate that acupuncture may be
      beneficial in decreasing time to recovery of bowel function and decrease the body's
      inflammatory response. However, this has not been studied in a randomized, prospective
      fashion in colon surgery. The goal of this study is to determine if acupuncture may be
      utilized as a therapeutic modality to decrease time to return of bowel function and discharge
      from the hospital.
    

Detailed description: 
      The pathogenesis of post-operative ileus is not completely known. It is thought that
      post-operative ileus involves trauma to the bowel. This traumatizing of the intestine and
      peritoneal surfaces results in production and release of inflammatory mediators. These in
      turn, lead to inactivation of inhibitory neural reflexes. There is also an additive effect of
      opioids used for post-operative pain, aggravating and adding to the duration of
      post-operative ileus. Acupuncture has shown promise in both human and animal model studies to
      reduce post-operative nausea and vomiting and post-operative ileus. It is the investigator's
      hypothesis that acupuncture will minimize or reduce both post-operative ileus and nausea
      following elective colon surgery and will lead to a decrease in inflammatory markers that are
      known to be elevated following abdominal surgery.

      The study goals are to determine if acupuncture:

        -  Leads to earlier return of bowel function

        -  Leads to earlier time to discharge following colon surgery

        -  Leads to earlier return of colonic motility

        -  Leads to decreased postoperative nausea and vomiting

        -  Leads to a decrease in inflammation
    

Intervention name(s): Acupuncture; Sham acupuncture
Intervention type(s): Other; Other
Intervention description(s): Treatment acupuncture group: therapeutic acupuncture treatment with actual needles; SHAM (control) acupuncture group: non-therapeutic acupuncture treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: acupuncture; colon surgery; post operative ileus; post ileus; ileus; colectomy; colorectal pathology
Epidural Analgesia Versus IV Meperidine for Labor Pain Control
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      60 female that care for pain control during second stage of delivery, will choose between
      epidural or systemic analgesia. Continuous ECG (3 lead)monitoring will be recorded during the
      second stage for 10 minutes. 30 minutes after administration of either pain relief, a second
      recording of maternal ECG will take place for 10 minutes.
    

Detailed description: 
      Population 60 female during second stage of delivery

        -  Inclusion criteria : all parturients requiring pain relief will choose between systemic
           or epidural analgesia.

        -  Exclusion Criteria: all parturients with cardiac disease, neurological disease,
           endocrine disease, diabetes, hypertension or any parturients being treated with
           medications that might effect the cardiovascular autonomic system.

        -  Method: A 10 minute recording of a 3 lead ECG will be performed during the second stage
           of the delivery (3-7 CM opening).

      the parturient will be lying on her left side for that period.

        -  30 minutes after administration of either epidural or systemic Meperidine for pain
           relief, a second recording of maternal ECG will take place for 10 minutes.

        -  estimated duration of the procedure about one hour per woman.
    

Intervention name(s): ECG recording; Epidural catheter insertion; Intravenous meperidine injection; Epidural Bupivacaine and fentanyl injection
Intervention type(s): Procedure; Procedure; Drug; Drug
Intervention MeSH terms: Fentanyl; Meperidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Opioid Analgesic Reduction Study (OARS) - Pilot
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test protocols being developed for the conduct of a large
      sale multi-site clinical trial which will compare opioids to non-opioids for managing
      post-surgical impacted 3rd molar extraction pain.
    

Detailed description: 
      A double-blind stratified randomized clinical trial is being conduct on the management of
      post-surgical pain after extraction of impacted third mandibular molars Subjects will be
      randomly assigned to either the OPIOID or NON-OPIOID group.
    

Intervention name(s): OPIOID; NON-OPIOID
Intervention type(s): Drug; Drug
Intervention description(s): Analgesic assignment; Analgesic assignment
Other intervention name(s): Opioid containing analgesic; Non-opioid contains analgesic
Intervention MeSH terms: Analgesics, Opioid; Analgesics; Analgesics, Non-Narcotic
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A double-blind stratified randomized clinical trial is being conduct on the management of post-surgical pain after extraction of impacted third mandibular molars Subjects will be randomly assigned to either the OPIOID or NON-OPIOID group.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Opioids; Pain Management; Analgesics
Safety, Tolerability, and Efficacy of GS-9876 in Participants With Active Rheumatoid Arthritis on Background Therapy With Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the effect of GS-9876 versus placebo for
      the treatment of signs and symptoms of rheumatoid arthritis (RA) in participants with active
      RA as measured by change from baseline in Disease Activity Score for 28 joint count using
      C-reactive protein (CRP) (DAS28 (CRP)) at Week 12.
    


Intervention name(s): GS-9876; Filgotinib; GS-9876 placebo; Filgotinib placebo; Methotrexate
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): One tablet administered orally once daily; Two tablets administered orally once daily; One tablet administered orally once daily; Two tablets administered orally once daily; Background therapy with methotrexate administered orally or parenterally once weekly
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Six Month Study of Gentamicin in Duchenne Muscular Dystrophy With Stop Codons
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety of giving intravenous (IV) gentamicin to
      boys with Duchenne muscular dystrophy who have stop codon mutations.
    

Detailed description: 
      The primary purpose of this second cohort is to see if the IV Medication, gentamicin, is safe
      to give twice a week for six months to boys with Duchenne muscular dystrophy (DMD).
      Secondarily, we want to know if gentamicin can help strengthen the muscles of boys with DMD
      who have a particular type of genetic mutation known as a stop codon. The gentamicin is
      thought to allow for "read-through" of this type of mutation which would allow for the
      production of dystrophin, a protein which is lacking in boys with DMD.
    

Intervention name(s): Gentamicin infusions twice a week for six months
Intervention type(s): Drug
Intervention description(s): Gentamicin infusions twice a week
Intervention MeSH terms: Gentamicins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stop codon mutations
Efficacy of 1540 Nanometer Erbium Glass Laser to Improve Benign Dermatofibromas
Condition: Dermatofibroma of Skin
MeSH terms: Histiocytoma, Benign Fibrous; Histiocytoma
Study type: Interventional

Summary: 
      This study is to find a more effective treatment for itchy, painful or unsightly
      dermatofibromas, that will improve symptoms of itch and/or pain and/or improve the appearance
      of dermatofibromas. This is an open-label study where subjects will receive a laser treatment
      at week 0, and week 4, and then 2 additional follow-up visits. Photographs will be taken at
      each visit and rated by blinded reviewers after the study to determine efficacy.
    

Detailed description: 
      The main objective of this study is to find a more effective treatment for itchy, painful or
      unsightly dermatofibromas, that will improve symptoms of itch and/or pain and/or improve the
      appearance of dermatofibromas. A secondary objective of this study is to better understand
      the 1540 nanometer Erbium glass laser and its impact on the skin.

      This is an open-label study where subjects will receive a laser treatment at week 0, and week
      4, and then have 2 additional follow-up visits (no laser treatment at these visits).
      Photographs will be taken at each visit and photographs from pre-treatment and follow-up 1
      (week 8) will rated by blinded reviewers after the study to determine efficacy.
    

Intervention name(s): 1540 nanometer Erbium glass laser
Intervention type(s): Device
Intervention description(s): Subjects will receive laser treatment by dermatologist at week 0 and week 4.
Intervention model: Single Group Assignment
Intervention model description: All subjects will have their dermatofibromas treated with the laser at week 0, and week 4. Blinded outcome assessors will rate photos (pre-treatment and follow-up visit 1) to determine efficacy.
Masking: None (Open Label)
Primary purpose: Treatment
Pre-operative Ultrasonographic Evaluation of Caval Aorta Diameter Index as a Predictor for Post-induction Hypotension
Condition: Hypotension on Induction
MeSH terms: Hypotension
Study type: Observational

Summary: 
      Comparison between ultrasound measurement of IVCD-AOd index in prediction of post induction
      hypo tension
    

Detailed description: 
      This study aims to evaluate the ability of preoperative ultrasound measurements IVC to aorta
      diameter index to predict post-induction hypotension in comparison with ultrasound
      measurements of the IVC collapsibility index.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        • Patients scheduled for elective orthopedic surgeries under general anaesthesia
PK/PD Study of Vicagrel and Clopidogrel in Healthy Subjects With Different CYP2C19 Metabolizers
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical study will adopt an open-label, randomized, multiple-dose, two-crossover design
      to explore the pharmacokinetic and pharmacodynamic profiles of Vicagrel Capsules and
      Clopidogrel Tablets in Healthy Subjects with Different CYP2C19 Metabolizers
    


Intervention name(s): vicagrel Capsules; Clopidogrel Tablets
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration for 7 days under fasting; Oral administration for 7 days under fasting
Other intervention name(s): PLAVIX
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Multiple-center, open-label, randomized, multiple-dose, crossover design
Masking: None (Open Label)
Primary purpose: Treatment
To Study Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD1656 in Japanese Type 2 Diabetes Mellitus (T2DM) Patients
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of AZD1656 after multiple
      repeated oral doses in Japanese patients with type 2 diabetes.
    


Intervention name(s): AZD1656; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Three increasing dose-steps with oral suspension, 8 days treatment; Placebo oral suspension, 8 days treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: AZD1656; Safety; Pharmacokinetics; Pharmacodynamic; Multiple ascending doses; Japanese; T2DM