bioihbjkbjnl/mcl2 huggingface dataset:
Pelvic Osteotomy Of The Total Hip Replacement
Condition: Congenital Hip Dysplasia; Hip Osteoarthritis
MeSH terms: Osteoarthritis, Hip; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital
Study type: Observational

Summary: 
      This observational study aims to learn about the outcomes in the previously operated patient
      and whether pelvic bone rearrangement surgery was a success.

      The main question it aims to answer is:

      • Should the investigators perform pelvic rearrangement surgery on a patient if there's not
      enough bone stock to accomplish the exchange of the components?

      As the research started the participant was asked to attend outpatient clinics regularly and
      keep in touch. The investigators were able to observe the outcomes and closely explore
      probable risks for failure.
    

Detailed description: 
      A 56-year-old female patient had a hip operation one year previously and experienced her
      first dislocation two months postoperatively. The patient underwent closed reduction three
      times. The patient presented to us due to a fourth hip dislocation that had occurred one
      month previously. Hip X-ray images revealed acetabular component malposition, with an
      80-degree inclination and 20 degrees of cup anteversion with a posterior hip dislocation. The
      investigators treated the patient via pelvic osteotomy, using a modified Stoppa approach to
      reduce acetabular inclination. The patient had no dislocation at the 2-year follow-up. At the
      last follow-up, the Harris Hip Score was 85.
    

Intervention name(s): Pelvic Osteotomy - Ganz Procedure
Intervention type(s): Procedure
Intervention description(s): Ischial osteotomy was performed on the pubic arch; this was followed by iliac osteotomy, performed using Schanz screws in the iliac wing. The osteotomized acetabulum was overturned, and inclination was reduced.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Since this is a single-case observational study, a population description could not be
        made.
      
Keywords: revision hip arthroplasty
Usefulness of Shirodhara for Insomnia
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This pilot study will attempt to test the effects of this non-invasive procedure on a small
      sample of insomnia patients and also determine the feasibility of recruiting and retaining
      participants during the trial for such treatments in the United States.
    

Detailed description: 
      A prospective case series design will be adopted. Due to the small sample size and the
      preliminary nature of the study, a single case study or case series are classified under
      Observational Descriptive Studies. The investigators will seek local Institutional Review
      Board (IRB) approval. Ten volunteers who respond to the recruitment efforts will be enrolled
      into the study. Successful enrollment is based on strict inclusion and exclusion criteria.
      Brahmi oil (sesame oil processed with Bacopa monieri and other herbs) will be used to perform
      Shirodhara. Each participant will be treated for 40 minutes for five consecutive days.
      Outcome measures data will be collected at baseline, third day and fifth day and a week after
      the treatment is over. Additionally, demographic data will be collected at baseline as well.
      Participants will be asked to record any adverse events or side effects they observe during
      the study period.
    

Intervention name(s): Shirodhara Oil Treatment
Intervention type(s): Procedure
Intervention description(s): Oil dripping on the forehead in a constant stream for about 40 minutes for five consecutive days.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Insomnia; Ayurveda; Shirodhara; Quality of Life
DP13 SAD & MAD in Healthy Male Subjects
Condition: Safety and Tolerability
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objectives:

        1. To determine the safety and tolerability of single and multiple oral doses of DP13 in
           healthy male subjects

        2. To assess the pharmacodynamics of single and multiple ascending oral doses as well as
           dosing regimen of DP13 on suppression of serum aldosterone in healthy male subjects

      Secondary Objectives:

        1. To determine the single and multiple oral dose pharmacokinetics of DP13 in healthy male
           subjects

        2. To determine the dose-dependent pharmacodynamic selectivity of DP13 in healthy male
           subjects
    


Intervention name(s): DP13; placebo
Intervention type(s): Drug; Drug
Intervention description(s): dose escalation; control to dose-escalation
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Non-steroid Antiinflammatory Drugs to Heal Colles Fracture
Condition: Colles Fracture
MeSH terms: Colles' Fracture; Fractures, Bone
Study type: Interventional

Summary: 
      It is believed that some painkillers (NSAID drugs) slow bone healing but the knowledge is
      based only on experimental studies with animals whose results are automatically translated
      for humans. The purpose is to examine whether these drugs slow bone healing and what
      relationship there is between different bone examinations, scan for osteoporosis, bone marker
      laboratory tests, radiological controls and histology of newly formed bone under a
      microscope.
    

Detailed description: 
      One of the most popular painkillers in the world is known as NSAID (non-steroidal
      anti-inflammatory drugs). Many studies with animals have been made which show a clear
      tendency for delayed bone healing by taking NSAIDs.

      It is known that an early intake of NSAIDs prevents ectopic ossification in patients,
      receiving total hip prosthesis. However, cases of prosthetic loosening and instability after
      10 years were almost exclusively observed in the group of patients who received NSAIDs
      postoperatively. However, very few clinical studies still show this tendency. In this study
      we include patients with fresh fracture in the wrist; Colles fracture. The fracture may seem
      unstable when there is a lack of bone healing. These fractures are very common in the
      orthopaedic clinic.

      Although there is no dislocation of the fragments, newly formed bone can be weaker as
      demonstrated by DEXA scanning (bone mineral density measurement). Histological examination of
      the healing bone can give a definitive answer whether the bone was affected or not. Thus, the
      possibilities of studying NSAIDs affect on bone healing in humans and the clinical
      significance are very positive.
    

Intervention name(s): Tablets Ibumetin and placebo; Tablets Ibumetin and placebo
Intervention type(s): Drug; Drug
Intervention description(s): Group A: Daily tablets Ibumetin, 600 mg x 3, 7 days after reposition.
Group B: Daily tablets Ibumetin, 600 mg x 3, 3 days after reposition. The following days placebo tablets.
Group C: Placebo tablets 1 week after reposition.; Group A: Daily tablets Ibumetin, 600 mg x 3, 7 days after surgery.
Group B: Daily tablets Ibumetin, 600 mg x 3, 3 days after surgery. The following days placebo tablets.
Group C: Placebo tablets for 1 week after surgery.
Other intervention name(s): No other names.; No other names.
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Colles fracture; Non-steroid antiinflammatory drugs; Bone healing
Cediranib (AZD2171, RECENTIN™) in Addition to Chemotherapy in Patients With Untreated Metastatic Colorectal Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if Cediranib when added to chemotherapy is more
      effective than chemotherapy alone in prolonging life expectancy and slowing disease
      progression in patients with previously untreated metastatic colorectal cancer.
    


Intervention name(s): Cediranib; FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin); XELOX (Capecitabine and Oxaliplatin); Cediranib Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): oral tablet; intravenous infusion; intravenous oxaliplatin 130 mg/ m^2(day 1) followed by oral capecitabine 1,000 mg/ m^2twice daily (day 1 to day 15); oral tablet
Other intervention name(s): AZD2171; RECENTIN™; Other Names:; 5-FU; Drug: Leucovorin (in FOLFOX); intravenous infusion; Drug: Oxaliplatin (in FOLFOX); Eloxatin®; Xeloda® + Eloxatin®
Intervention MeSH terms: Leucovorin; Capecitabine; Fluorouracil; Oxaliplatin; Cediranib; Levoleucovorin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Colorectal Cancer; Cediranib; RECENTIN
Tizanidine and Superficial Cervical Block on Pain After Thyroidectomy
Condition: Thyroidectomy
Study type: Interventional
Phase: Phase 4

Summary: 
      Thyroid surgery is a quite painful procedure performed in a sensitive skin area of the human
      body. Unless pain is treated adequately thyroid surgery may cause severe postoperative pain
      and discomfort for the patients.

      a2-Agonists are sympatholytic and centrally acting antihypertensive agents. In addition to
      their hypotensive effect, a2-agonists are also used in anesthetic practice for their sedative
      and analgesic effects. Tizanidine is a centrally acting a2-agonist with muscle relaxant,
      sedative and anxiolytic properties. This drug is widely used for the treatment of spasticity
      and has recently been used to treat musculoskeletal pain conditions.

      Ultrasound (US) guidance during regional anesthesia practices has been a revolutionary
      advancement to improve success and safety of regional anesthesia. Analgesic effect of US
      guidance superficial cervical plexus block (SCPB) in patients undergoing thyroid surgery has
      not been reported yet.

      The aim of this study was to evaluate the analgesic effect of preemptive oral single dose
      tizanidine and US guidance SCPB in patients undergoing elective thyroid surgery. The
      investigators hypothesis that: Tizanidine and US guided SCPB can reduce the pain scores,
      analgesic consumption, analgesic related side effects.
    


Intervention name(s): Placebo; Tizanidine; Bupivacaine; Saline
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Group Placebo: will receive a placebo pill 1 hour before surgery; Group T: 6 mg tizanidine1 hour before surgery; Group Bupivacaine will receive USG guided SCPB with %0,25 bupivacaine bilaterally 10 ml each side; USG guided SCPB with saline bilaterally 10 ml each side
Other intervention name(s): Placebo pill; Sirdalud MR; Saline block
Intervention MeSH terms: Tizanidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Thyroidectomy pain; Tizanidine; Postoperative analgesia; Ultrasound guided Superficial cervical plexus block
Resolution of Allergic Inflammation
Condition: Grass Pollen Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Inflammation
Study type: Interventional

Summary: 
      After an allergen challenge, the allergic inflammatory response disappears spontaneously. The
      initiation of the resolution of the inflammatory response is now recognized as a dynamic
      process, involving active biochemical programs that enable inflamed tissues to return to
      homeostasis. Recent data established key roles of different specific lipid mediators in the
      endogenous counter-regulation of inflammation and activation of resolution. Only little is
      known about kinetics of these specialized pro-resolving lipid mediators during acute allergic
      inflammation. Therefore, the primary propose of our study is to characterize the temporal
      evolution of cellular inflammation and specific lipid mediators after allergen challenge.
    


Intervention name(s): Grass pollen allergen extract; placebo
Intervention type(s): Other; Other
Intervention description(s): Each subject will be challenged with a grass pollen allergen extract and with placebo.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Standardization of Surgery on the Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was designed to test the hypothesis that more extensive nodal and soft-tissue
      clearance in patients with adenocarcinoma of the head of the pancreas would improve survival
      without an increase in morbidity and mortality.
    

Detailed description: 
      In Japan and in some western treatment centers, there has been a general belief that more
      extensive surgery may improve outcome for patients with localized, operable pancreatic
      adenocarcinoma. Initial retrospective reports from centers in Japan suggested that 5-year
      overall survival rates in patients treated with pancreaticoduodenectomy plus extended
      lymphadenectomy were higher than those in patients treated by pancreaticoduodenectomy with
      standard lymphadenectomy. Subsequent prospective randomized trials performed in Europe and
      the United States failed to confirm a survival benefit from extended lymphadenectomy.
      Although they failed to confirm a survival benefit from extended lymphadenectomy, the studies
      had a few pitfalls. The need for Well-designed randomised controlled study is the starting
      point of our study. This study was designed to test the hypothesis that more extensive nodal
      and soft-tissue clearance in patients with adenocarcinoma of the head of the pancreas would
      improve survival without an increase in morbidity and mortality.
    

Intervention name(s): Standard pancreatoduodenectomy; Extended pancreatoduodenectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Standard pancreatoduodenectomy; Extended pancreatoduodenectomy
Other intervention name(s): Extended lymphadenectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Pancreatic cancer; Pancreaticoduodenectomy; Extended lymphadenectomy
Open Label Study Evaluating the Effects of a Single Oritavancin Infusion on Cytochrome P450 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the effects of oritavancin on the in vivo activities
      of CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP3A, NAT 2, and XO using a Cooperstown 5 + 1 cocktail
      in an open label, single arm manner.
    


Intervention name(s): Single-Dose IV Oritavancin Diphosphate
Intervention type(s): Drug
Intervention description(s): Oritavancin will be administered as a single IV infusion. The infusion will last approximately 3 hours.
Other intervention name(s): Oritavancin Diphosphate
Intervention MeSH terms: Oritavancin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Cigarette Pack Warnings and Packaging Among Young Adult Smokers
Condition: Tobacco Use
Study type: Interventional

Summary: 
      The objective of this study is to examine whether cigarette packaging regulations including
      graphic health warning labels on cigarette packs and requiring plain, unbranded packaging
      reduce the appeal of cigarettes and prompt young adult smokers to quit.
    

Detailed description: 
      The study includes young adult smokers ages 18 to 30. Eligible participants are young adults
      ages 18 to 30 years inclusive who report smoking at least 100 lifetime cigarettes and now
      smoking on all or some days. Participants must also reside in the metro Washington, DC area.
      The first portion of the study is a within-subjects experiment simulating point of sale
      cigarette purchase behaviors based on 2 packaging features: (1) graphic warning messages
      framed to emphasize either the health benefits of quitting (i.e., gain framed) or the health
      risks of smoking (i.e., loss-framed) and (2) industry branded or plain (i.e., standardized
      unbranded) packaging. In the second portion of the study, the same participants take part in
      a prospective experiment to determine the impact of graphic cigarette warning message framing
      (gain versus loss) and packaging (branded versus plain) on motivation to quit and smoking
      behavior. Participants are randomized to use 1 of 4 experimentally adapted cigarette packs in
      place of their regular packs for 4 weeks, or to a control condition which will continue to
      use their regular packs. All participants complete baseline and follow-up assessments and
      respond to daily mobile phone text message prompts on their personal mobile phones during the
      4 week exposure period. Participants complete follow-up assessments capturing motivation to
      quit, smoking behavior, and quit attempts at the conclusion of the 4 week exposure period and
      1- and 3-months later.
    

Intervention name(s): Graphic cigarette warning labels, plain packaging
Intervention type(s): Behavioral
Intervention description(s): This study tests the effects of graphic cigarette warning labels that include pictures and text, and plain or standardized packaging
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: The experimental design is a 2 (graphic warning message framing: gain versus loss) by 2 (cigarette packaging: standardized, plain or branded) factorial design. An unexposed control group is also included.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Young adults; Cigarette smoking; Warning labels
Evaluation of Articaine 4% Versus Mepivacaine 2% for Surgery of Molars Thirds: Clinical Trial.
Condition: Pain; Teeth, Impacted
MeSH terms: Tooth, Impacted
Study type: Interventional

Summary: 
      The extraction of third molars, a frequent treatment in clinical dental practice, can lead
      patients to painful symptoms during and after surgery. The dental surgeon must correctly
      indicate the need for extraction and also provide patients who need this treatment greater
      comfort and control of pain in the trans and postoperative period. Thus, it is necessary to
      use an effective local anesthetic favoring the factors inherent to the postoperative and
      achieving good treatment results.
    

Detailed description: 
      This study will compare the use of Articaine at 4% to that of Mepivacaine at 2% for lower
      third molar surgeries semi-included and / or included. I will select 16 patients who require
      surgical treatment for extraction of third molars, aged between 16 and 40 years at the São
      Paulo State University. These will participate simultaneously in the two groups: Group 1
      mepivacaine (MEP) and Group 2 articaine (ART), and the division will be performed by
      randomization, so that each patient will have each side (right or left) allocated in
      different groups. The primary evaluation variable will be to compare the pain index in the
      immediate postoperative period, using Visual Analog Scale (VAS), and will also analyze
      Hemodynamic Parameters, such as Patient and Operator satisfaction. The results will be
      submitted to qualitative and quantitative statistical analysis. The descriptive data will be
      compared using the statistical analysis of variance (ANOVA) and Tukey test with a
      significance level of 5%.
    

Intervention name(s): Group 1 -Pain monitor; Group 2 -Pain monitor
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Use of the anesthetic Mepivacaine 2% in third molar extraction and evaluation in postoperative; Use of the anesthetic Articaine 4% in third molar extraction and evaluation in postoperative
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The sample will consist of 32 lower third molars, semi-inclusively or included. This study will be a randomized, double blind, controlled, split-mouth clinical trial, divided into two groups simultaneously, namely:
Group 1 (16 teeth) - using anesthetic mepivacaine in third molar extraction. Group 2 (16 teeth) - using anesthetic articaine in third molar extraction
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Pain; Third molar; Articaine; Mepivacaine
Dexmedetomidine and Propofol in Children With History of Obstructive Sleep Apnea
Condition: Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research study is to examine the effects of two commonly used anesthetic
      drugs, dexmedetomidine and propofol, have on the shape and muscle tone of the upper airway in
      children, adolescents, and young adults with a history of obstructive sleep apnea (OSA)
      having an MRI scan.

      The results of this study will help in making the best decisions regarding the anesthesia
      medications that are most appropriate for children, adolescents, and young adults with OSA
      during MRI studies.
    

Detailed description: 
      Patients with OSA are at risk for airway obstruction (a condition that makes it difficult to
      breath) during sedation and anesthesia. Dexmedetomidine and propofol are safe and effective
      drugs regularly used by anesthesiologists. These drugs are used to put patients to sleep for
      operations and certain studies like MRI scans. However, there have been no studies describing
      the effects these drugs have on the upper airway of children, adolescents, and young adults
      with OSA.
    

Intervention name(s): Dexmedetomidine; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump.; Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump.
Other intervention name(s): Precedex; Diprivan
Intervention MeSH terms: Dexmedetomidine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obstructive Sleep Apnea; MRI; Pediatrics; Dexmedetomidine; Propofol; Anesthesia