bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of a Single Spinal Manipulation on Cardiovascular Autonomic Activity
Condition: Manipulation, Spinal
Study type: Interventional

Summary: 
      This study evaluates the effect of a single high-velocity low-amplitude spinal manipulation
      on both cardiovascular autonomic activity and pressure pain thresholds.

      It is a cross-over study, thus each participant will undergo both interventions (spinal
      manipulation and sham manipulation). Both interventions will be separated by a 48 h wash-out
      period.
    

Detailed description: 
      Several systematic reviews have shown that spinal manipulations may have an immediate effect
      on autonomic nervous system activity (e.g. increase in skin sympathetic nerve activity) and
      on sensitivity to experimentally-induced pain (e.g. increase in pressure pain threshold).

      It is generally unknown i) if these supposed effects last after the immediate post
      intervention period and ii) if there is a statistical relationship between them, considering
      that pain and autonomic networks are closely connected and interact at the peripheral, spinal
      and supra-spinal levels.

      The primary aim of the study is to assess every single effect immediatly and at short-term
      after the intervention.

      The secondary aim is to assess the bivariate statistical relationship between cardiovascular
      autonomic activity and sensitivity to experimentally-induced pain after the intervention.

      Cardiovascular autonomic nervous system activity is assessed with both heart rate and
      systolic blood variabilities

      Sensitivity to experimentally-induced pain is measured using pressure pain threshold.
    

Intervention name(s): High velocity low amplitude manipulation; Sham manipulation
Intervention type(s): Other; Other
Intervention description(s): The researcher manually applies a preload force on the T5/T6 level followed by a single posterior to anterior thrust.; The researcher manually applies a preload force on the right scapula followed by a single lateral thrust.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
NMDA-enhancing Agent for Treatment of Mild Cognitive Impairment and Mild Alzheimer's Disease
Condition: Alzheimer's Disease; Mild Cognitive Impairment
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      NMDA activation plays an important role in learning and memory. NMDA receptors were found to
      decrease in the frontal lobe and hippocampus of Alzheimer's disease and mild cognitive
      function impairment. This study is a randomized, double-blind, placebo-controlled drug trial.
      All patients will be allocated randomly to 2 groups: (1) NMDA enhancer: DAOI-B group
      (starting dose: 250-500 mg/d); (2) placebo group. The study period is 24 weeks. The
      investigators hypothesize that DAOI-B may yield better efficacy than placebo for cognitive
      function in patients with mild cognitive impairment or mild Alzheimer's disease.
    


Intervention name(s): DAOI-B; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 250-1500 mg/day, oral, for 24 weeks; placebo, oral, for 24 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's disease; mild cognitive impairment; NMDA
Mycotic Antimicrobial Localized Injection for Treatment of Corneal Ulcers
Condition: Corneal Ulcer; Fungal Keratitis
MeSH terms: Corneal Ulcer; Keratitis; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      Mycotic Antimicrobial Localized Injection (MALIN) is a randomized, masked, two-arm clinical
      trial investigating intrastromal voriconazole in the treatment of fungal corneal ulcers.
      There is currently little evidence to guide the treatment of fungal keratitis beyond topical
      anti-fungal drops, though intrastromal voriconazole and oral antifungal treatments are used
      as well. This study will provide evidence to guide the treatment of fungal keratitis in the
      future. The purpose of this study is to determine differences in microbiological cure for
      3-day repeat cultures between different antifungal treatments. For this study, there will be
      1:1 randomization to one of these two treatment groups: 1) topical natamycin plus
      intrastromal voriconazole injection or 2) topical natamycin alone.
    

Detailed description: 
      The proposed study is a randomized controlled trial to determine whether intrastromal
      voriconazole improves outcomes in fungal keratitis. Patients presenting to the Aravind Eye
      Hospitals in Pondicherry, India for treatment of fungal keratitis will be recruited for the
      proposed study. Approximately 70 patients will be enrolled in the study. Subjects presenting
      with fungal keratitis will be randomized to receive topical natamycin plus intrastromal
      voriconazole or to receive topical natamycin alone. Subjects may also receive oral
      antifungals after day 3 at the discretion of the treating clinician. All study subjects will
      be followed for 3 months to evaluate response to treatment.

      Investigators from the University of California, San Francisco (UCSF) will assist Aravind Eye
      Hospital with the study design, implementation, and analysis of the research, and will help
      fund the study. The investigators will visit Aravind to help with the study implementation.
      UCSF will play an important role in this study by assisting with the study design,
      implementation, analysis, and funding.
    

Intervention name(s): Intrastromal voriconazole; Natamycin
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive three intrastromal voriconazole injections over 10 days. Intrastromal voriconazole injection is a routine procedure performed by Aravind Eye Hospital for fungal keratitis.; Subjects will receive topical 5% natamycin drops hourly for 3 days.
Intervention MeSH terms: Voriconazole; Natamycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: cornea; ulcer; fungal; keratitis
Physiologic Evaluation of Anomalous Right Coronary Artery Stenosis
Condition: Coronary Vessel Anomalies
MeSH terms: Coronary Stenosis; Coronary Vessel Anomalies
Study type: Interventional
Phase: Phase 4

Summary: 
      The anomalous origin of right coronary artery (RCA) is a rare coronary anomaly. Recently, the
      detection of this anomaly has been more frequent as the use of cardiac multidetector computed
      tomography has become more popular. It can cause myocardial ischemia, syncope and sudden
      cardiac death. Surgical repair is generally recommended for symptomatic patients. However,
      there is controversy concerning the proper evaluation and treatment strategy for patients
      without documented myocardial ischemia.

      The stenotic lesion of anomalous origin of RCA will be assessed by fractional flow reserve
      (FFR).
    


Intervention name(s): revascularization
Intervention type(s): Procedure
Intervention description(s): surgery or stenting
Other intervention name(s): other names are not available
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Coronary Vessel Anomalies
Comparative Evaluation of Ultrasound Guided Supraclavicular and Infraclavicular Subclavian Venous Catheterizations in Adult Patients Undergoing Major Surgeries
Condition: Compare Central Line Insertion of Subclavian Vein With Two Different Approaches Using Ultrasound
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparison of two techniques of central venous cannulation of subclavian vein using
      ultrasound was performed. ultrasound guided central venous cannulation is the standard
      practice today but its use in subclavian vein is technically challenging and not much
      literature is available. In this study 96 Patients were randomized into one of the groups and
      compared for various outcomes. The primary outcome studied was the time taken for procedure.
      Secondary objectives included comparison of total access time using both the
      techniques,comparison of first attempt success rate, comparison of the quality of needle
      visualization and the comparison of immediate (mechanical) and delayed complication rates.
    


Intervention name(s): ultrasound guided central venous cannulation
Intervention type(s): Procedure
Intervention description(s): ultrasound is a medical device which is frequently used for safe venous punctures as you can visualise the structures.so, device ''ultrasound'' will be used for intervention ''central line insertion'' in subclavian vein. ultrasound guided cannulation of the subclavian vein was done by supraclavicular or infraclavicular approach after randomization into either of the two groups.In the supraclavicular approach the puncture site is above the clavicle while in the infraclavicular group the puncture site is below the clavicle. Central venous cannulation is done after identifying the vein on ultrasound and using standard seldinger technique with full asepsis.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-64264681 in Healthy Male and Female Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to investigate the safety, tolerability,
      pharmacokinetics (PK) and pharmacodynamics (PD) of JNJ-64264681 in healthy participants after
      single and multiple oral doses.
    


Intervention name(s): JNJ-64264681; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): For all cohorts except the solid dose formulation cohort, JNJ-64264681 wlll be administered as oral solution. For the solid dose formulation cohort, JNJ-64264681 will be provided as capsules for oral administration.; Matching placebo to JNJ-64264681 will be administered as oral solution.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
RCT of Pulp Capping Over Carious Exposure in Adults
Condition: Carious Exposure; Human Permanent First and Second Molars; Mature Teeth; Proximal Caries; Healthy Pulp; Reversible Pulpitis
MeSH terms: Pulpitis
Study type: Interventional

Summary: 
      This multicentre study was a randomized, controlled, parallel, patient-blinded, two-arm
      superiority trial with a 1:1 allocation ratio that followed the CONSORT guidelines.The aim of
      this study was to investigate whether MTA is more effective than a conventional calcium
      hydroxide liner (Dycal®) as a direct pulp capping material in mature molar teeth with a
      carious pulpal exposure.
    

Detailed description: 
      Calcium hydroxide (CH) is considered the standard material for pulp capping with good results
      in cases with pulpal exposure as a result of dental trauma both in animal and clinical
      studies. However, in carious exposures, follow-up studies of direct pulp capping performed
      with CH based materials have shown increasing failure rates and the outcome has been
      considered uncertain. Direct capping of carious exposures still remains a controversial
      treatment for mature teeth.

      A new material, mineral trioxide aggregate (MTA) was introduced for root end filling material
      almost two decades ago. It is also suggested for pulp capping. MTA cement has showed good
      sealing ability and bio-compatibility in animal studies. Results from studies in humans
      corroborate the results from animal studies.

      Although the overall results of pulp capping in human studies using MTA are very positive,
      well designed and controlled clinical studies, especially involving carious exposures on
      adult teeth are lacking.At the time the present study was launched, there were no RCTs
      comparing MTA and CH as DPC materials and the histological evaluations have primarily been
      based on healthy teeth, thus undermining the generalizability of the results to adult
      patients with carious exposures.
    

Intervention name(s): Direct pulp capping with Dycal; Direct pulp capping
Intervention type(s): Procedure; Procedure
Intervention description(s): Capping over carious exposure with Dycal. Dycal: covered with Fuji IX. After one week, part of the temporary filling was left under the permanent filling; WMTA capping over exposed pulp, wet pellet, Fuji IX. After one week, the entire temporary filling was removed,the cavity was permanently restored with a composite resin material used at the study clinic.
Other intervention name(s): (Dycal®, Dentsply DeTrey GmbH, Konstanz, Germany; WMTA - White Mineral Trioxide Aggregate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multicenter study a randomized, controlled, parallel, patient-blinded, two-arm superiority trial with a 1:1 allocation ratio
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: carious exposure; pulp capping; MTA; Dycal
Sub Lingual Misoprostol Before IUD Insertion in Women With Only Previous Cesarean Section
Condition: IUD Insertion
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of the work is to evaluate the efficacy of the sub lingual prostaglandin E1 synthetic
      analogue (misoprostol) before IUD insertion to facilitate the procedure in patients delivered
      before only by cesarean section.
    

Detailed description: 
      The study will be conducted at Ain Shams University Maternity Hospital. 124 women candidate
      for Cu T 380A IUD insertion will be enrolled in the study. Half of them will receive 400
      micro gram of misoprostol (Sigma) sub lingually and the other half will receive the placebo
      two hours before IUD insertion.
    

Intervention name(s): Misoprostol; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Misotac; Cytotec; Misotec; Prostaglandin E1 synthetic analogue
Intervention MeSH terms: Alprostadil; Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: IUD; Misoprostol; Rectal administration
Study Comparing 2 New Formulations of HKI-272 in Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the comparative bioavailability of 2 new tablet formulations of HKI-272 with a
      reference capsule and an oral solution in healthy subjects.
    


Intervention name(s): neratinib
Intervention type(s): Drug
Intervention description(s): HKI-272
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Occlusal Splint and Masticatory Muscle Injection in Myofacial Pain
Condition: Myofacial Pain
MeSH terms: Facial Pain
Study type: Interventional

Summary: 
      Myofascial pain is one of the common symptoms in patients with temporomandibular joint
      disorders. Occlusal splint use, trigger point injections and the combination of this two
      methods are primary treatment options. Patients were divided into 3 groups and this three
      treatment was applied. We aimed to investigate the clinical and ultrasonographic effects of
      the treatments. Patients in the treatment groups were reexamined at 1st and 3rd months, and
      their clinic and ultrasonographic records were repeated. 16 healthy volunteers were also
      included in the study. No treatment was applied, only clinical and ultrasonographic records
      were taken once.
    

Detailed description: 
      48 patients who had myofacial pain and were diagnosed with according to Diagnostic Criteria
      for Temporomandibular Disorders were included in the study. There were 16 patients in each
      group. Group 1 was treated with occlusal splint, Group 2 was treated with occlusal splint and
      masseter muscle lidocaine injection, Group 3 was treated with masseter muscle lidocaine
      injection and Group 4 consisted of healthy volunteers. Visual analogue scale used for pain
      evaluation. Also, maximum mouth opening, lateral and protrusion movements of all groups were
      measured before any treatment. Masseter muscle volume was evaluated by ultrasonography
      whereas masseter muscle elasticity was evaluated by elastography before the masseter muscle
      lidocaine injection and occlusal splint treatment. In Group 2 and Group 3, masseter muscle
      injections were repeated two more times, on 7th and 14th days. Clinical and ultrasonographic
      measurements were repeated at 1st and 3rd months.
    

Intervention name(s): Occlusal splint treatment; Masticatory muscle injection; Combination of occlusal splint and masticatory muscle injection treatments
Intervention type(s): Device; Procedure; Combination Product
Intervention description(s): Occlusal splint was made for 16 patients and they used just this occlusal splint for 3 months.; Lidocaine was injected on 16 patients' three trigger point in the masseter muscle. Injection was repeated 3 times, once a week.; Lidocaine was injected on 16 patients' three trigger point in the masseter muscle. Occlusal splint was also made and they started to use the day which first injection was made. And continue to use the occlusal splint for 3 months. Injection was repeated 3 times, once a week.
Intervention MeSH terms: Salicylic Acid
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: A prospective randomized controlled clinical trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Myofacial Pain; Trigger point injection; Occlusal splint; Ultrasonography; Elastography
Bioavailability of Oseltamivir Phosphate 75 mg With Regards to Reference Product
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the bioavailability in fasting male and/or non-pregnant and non-
      breast feeding female subjects of 1 capsule formulation containing Oseltamivir Phosphate 75
      mg.

      The study will be performed at a single site with 36 subjects. Participants will take 1
      capsule of the test product and reference product in 2 periods and 2 sequences (either test
      after reference or reference after test). There will be a washout of at least 2 days between
      each study period.
    

Detailed description: 
      The primary objective of the study is to investigate the relative bioavailability of
      Oseltamivir Phosphate 75 mg of 1 capsule formulations with Oseltamivir Phosphate 75 mg and to
      demonstrate bioequivalence of both formulations in terms of rate and extent of absorption:

        -  Test Product: Product manufactured by Laboratorios Silesia S.A.

        -  Reference Product: Tamiflu [Trademark], product of Roche Pharma AG, Switzerland.

      The 90% confidence intervals for the intra-subject coefficient of variation (Test versus
      Reference Product) for the main pharmacokinetic parameters area under the plasma
      concentration-time curve from time zero to time t (AUC0 0-t) and from time zero to infinite
      (AUC0 0-∞), and maximum plasma concentration (Cmax) for total Oseltamivir Phosphate will be
      determined. Participants will be confined in the study site for approximately 68 hours during
      the entire study (for 10 hours pre-dosing and for 10 hours post dosing in period II) during
      which pharmacokinetic (PK) blood samples will be obtained. 20 blood samples will be taken up
      to 10 hours after the administration in each period.

      The washout period between the two study periods will be at least 2 days. The samples from
      each participant will be analyzed with validated LC-MS/MS method for estimation of
      Oseltamivir in plasma.

      The safety objective is to evaluate the tolerability of both formulations in subjects by
      collecting adverse events.
    

Intervention name(s): Oseltamivir 75mg Test Drug capsules; Oseltamivir 75mg capsules Reference Product capsules
Intervention type(s): Drug; Drug
Intervention description(s): Investigational Medicinal Product; Tamiflu (Roche Pharma (Switzerland) AG, Basel)
Intervention MeSH terms: Oseltamivir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Comparison of ENGBD and PTGBD in Acute Suppurative Cholecystitis
Condition: Success Rate
MeSH terms: Cholecystitis; Acalculous Cholecystitis
Study type: Interventional

Summary: 
      Comparison of ENGBD and PTGBD methods on clinical outcomes and the difficulty of
      cholecystectomy in later stage in patients with acute suppurative cholecystitis.
    

Detailed description: 
      Laparoscopic cholecystectomy was the standard surgical method for acute cholecystitis unless
      difficulty in resection due to acute inflammation, no improvement after supportive therapy,
      or early inability to tolerate cholecystectomy. In this setting, gallbladder drainage was
      needed. Percutaneous transhepatic gallbladder drainage (PTGBD)was used as a first-line
      mitigation method, whose restrictions are contraindications and strong pain caused by
      puncture. Endoscopic technique based on endoscopic retrograde cholangiopancreatography (ERCP)
      had been made another alternative management for drainage. Endoscopic drainage expanded the
      indications for drainage without reducing the technical success rate and clinical remission
      rate, especially less uncomfortable, which greatly improved the quality of life for patients.
      Unfortunately, because of the difficult procedures and long learning curve, endoscopic
      gallbladder drainage can only be performed in some large endoscopic centers. Despite a few
      prospective comparison of PTGBD and endoscopic ultrasound EUS drainage studies so far, there
      is no prospective study comparing endoscopic naso-gallbladder drainage （ENGBD） and PTGBD,
      especially in its impacts while cholecystectomy. This study aim to observe clinical effects
      of ENGBD and PTGBD during the all stage of peri-cholecystectomy.
    

Intervention name(s): Endoscopic naso-gallbladder drainage; Percutaneous gallbladder drainage
Intervention type(s): Procedure; Procedure
Intervention description(s): Using ERCP technique insert a naso-gallbladder drainage tube through common bile duct and cystic duct.; Percutaneous transhepatic technique insert drainage tube into gallbladder
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: ERCP; PTGBD; ENGBD; Gallbladder drainage; Cholecystitis
A Safety and Efficacy Study With YM543 in Type 2 Diabetes Mellitus Subjects
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the safety of YM543 in type 2 Diabetes Mellitus
      patients and to investigate whether this study drug is effective in these patients
    


Intervention name(s): YM543; Metformin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral; Oral; oral
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus Type 2; YM543; Treatment; Safety; efficacy