bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Intravenous Lignocaine Infusion on Intraoperative End Tidal Desflurane Concentration Requirements
Condition: Cholelithiases; Appendicitis; Ovarian Cysts
MeSH terms: Appendicitis; Ovarian Cysts; Cholelithiasis; Cholecystolithiasis; Gallstones
Study type: Interventional

Summary: 
      Lignocaine is a local anaesthetic that is widely used in all medical and surgical fields.
      Many clinical studies have shown that intravenous (IV) lignocaine given in the perioperative
      period was safe, reduced airway complications, obtunds cough reflex, reduce sore throat,
      pain, opioid consumption, nausea, length of hospital stay. Multiple animal studies have shown
      that IV lignocaine was able to lower anaesthetic gas requirements. Desflurane is an
      anaesthetic gas that has a rapid onset and offset of action. This study aims to evaluate the
      effect of IV lignocaine infusion on desflurane requirements.

      Hypothesis of the study is that IV lignocaine infusion reduces desflurane requirements.
    

Detailed description: 
      All volunteers will be randomly assigned into two groups based on computer generated
      randomisation tables.

      Group Lignocaine will receive an IV bolus dose of 1.5 mg/kg of 2% lignocaine HCL diluted up
      to 10 ml with normal saline in a 10 ml syringe which will be delivered via a syringe pump
      over a period of 3 min. This is then followed by an IV infusion at the rate of 1 mg/kg/h of
      2% lignocaine HCL in a 20 ml syringe which will be administered by another syringe pump.

      Group Placebo will receive an IV bolus of 10 ml of normal saline over a period of 3 min
      followed by an IV infusion of an equal volume of normal saline, both of which will be
      delivered by separate syringe pumps.

      After induction of anaesthesia, all volunteers will be ventilated with Aisys™ CS² anaesthesia
      machine. Anaesthesia shall be maintained with desflurane, in 50% oxygen-air balance with a
      total flow of 1.0 L/min. The end tidal desflurane (Et-Des) concentration will be adjusted to
      maintain a target BIS of between 40-60.

      Desflurane and study infusions will be discontinued and estimation of desflurane cost and
      volume used will be estimated at the end of surgery.
    

Intervention name(s): Lignocaine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): IV bolus of 1.5 mg/kg of lignocaine 2% diluted in 10 ml syringe over 3 mins followed by infusion at 1 mg/kg/h of lignocaine 2% in 20 ml syringe; IV bolus of 10 ml normal saline over 3 min followed by infusion of equal volume of normal saline in 20 ml syringe
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Lignocaine; Desflurane
Fasting Study of Levothyroxine Sodium Tablets 200 mg to Synthroid Tablets 200 mg
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine
      sodium 200 μg tablets to Abbott's Synthroid® 200 μg tablets following a single 600 μg (3 x
      200 μg) dose administration in healthy volunteers under fasting conditions. Twenty-nine
      healthy, non-smoking, subjects between the ages of 18 and 47 completed this open-label,
      randomized, two-period, two-treatment, single-dose crossover study conducted by Dr. James D.
      Carlson at PRACS Institute, Ltd., Fargo, ND. Statistical analysis of the data revealed that
      90% confidence intervals were within the acceptable bioequivalent range of 80% and 125% for
      the natural log transformed parameters LNAUC0-48hr and LNCPEAK for baseline corrected total
      L-thyroxine. This study demonstrated that Mylan's 200 μg levothyroxine sodium tablets are
      bioequivalent to Abbott's Synthroid® 200 μg tablets following a single, oral 600 μg (3 x 200
      μg) dose under fasting conditions
    


Intervention name(s): Levothyroxine Sodium Tablets 200 mg; Synthroid Tablets 200 mg
Intervention type(s): Drug; Drug
Intervention description(s): 3x200mcg, single dose fasting; 3x200mcg, single dose fasting
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
The Effect of Calcium Supplementation on Insulin Resistance and 24h Blood Pressure
Condition: Hypertension; Diabetes; Insulin Resistance
MeSH terms: Hypertension; Insulin Resistance
Study type: Interventional
Phase: Phase 4

Summary: 
      Increased levels of intracellular calcium are thought to diminish maximal cellular response
      to insulin and induce insulin resistance. Also, both hypertension and diabetes are thought to
      be conditions of altered intracellular ionic state. The aim of the present study is to
      investigate the possible effect of oral calcium supplementation on intracellular ions,
      insulin sensitivity, 24-h blood pressure and sodium/hydrogen exchanger activity in patients
      with type 2 diabetes and essential hypertension.
    


Intervention name(s): tablets each containing of 1000mg elemental calcium (Mega-Calcium Sandoz)
Intervention type(s): Dietary Supplement
Intervention description(s): 1500 mg of elemental calcium per day.
Other intervention name(s): Mega-Calcium Sandoz
Intervention MeSH terms: Calcium, Dietary; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: calcium supplementation; intracellular ions; sodium/hydrogen exchange activity
Effects of Kinesio Tape on Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This clinical trial aims to examine kinesiotape's (KT) short-term effect on individuals with
      nonspecific chronic LBP (CLBP), including back-specific body perception, pain, functional
      disability, and physical activity. The hypothesis is that applying KT to the lumbar spine
      would improve back-specific body perception, reduce pain and functional disability, and
      increase physical activity in individuals with CLBP compared to the sham-taping group.
    

Detailed description: 
      Low back pain (LBP) is prevalent and the leading cause of disability worldwide. In addition,
      it is often associated with psychological, social, and physical factors that can impact one's
      ability to function, participate in society, maintain job satisfaction, and socioeconomic
      status. Therefore, managing it requires a significant amount of healthcare resources.
      Maladaptive body image and maladaptive beliefs are among the conditions that can be targeted
      during treatment as they may contribute to the chronicity of LBP.

      This clinical trial aims to examine kinesiotape's (KT) short-term effect on individuals with
      nonspecific chronic LBP (CLBP), including back-specific body perception, pain, functional
      disability, and physical activity. The hypothesis is that applying KT to the lumbar spine
      would improve back-specific body perception, reduce pain and functional disability, and
      increase physical activity in individuals with CLBP compared to the sham-taping group.
    

Intervention name(s): Kinesiotape using Rocktape®; Sham taping
Intervention type(s): Other; Other
Intervention description(s): Kinesiotape using Rocktape® on day one by a physiotherapist who has experienced more than five years. If possible, the taping will be left for seven days.; sham taping with Rocktape®, with no tension.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: comparing the use of kinesiotape for the treatment of back-specific body image, pain, functional disability, and physical activity of individuals with non-specific CLBP to sham-taping
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: functional disability; pain; kinesiotape; physical activity
Single-ascending Dose Study With a Food-Effect Cohort to Evaluate AMG 581
Condition: Schizophrenia or Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to find out the time it takes to absorb, distribute, breakdown
      and remove the drug from the body, safety and tolerability of AMG 581 in healthy participants
      and subjects with schizophrenia.
    

Detailed description: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic
      profile of single-ascending oral doses of AMG 581 in healthy subjects and subjects diagnosed
      with schizophrenia or schizoaffective disorder receiving antipsychotic treatment.

      This will be a placebo-controlled, single-ascending oral-dose study of AMG 581 with a
      food-effect cohort. Approximately 70 subjects will be enrolled. This study will enroll
      healthy subjects into 8 cohorts (Cohorts 1,2,3,4,5,6,8 and 9), and subjects with
      schizophrenia or schizoaffective disorder receiving antipsychotic medication into a single
      cohort (Cohort 7).
    

Intervention name(s): AMG 581; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active drug; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia or Schizoaffective Disorder
Trans-perineal Repair With or Without Limited Internal Sphincterotomy for Treatment of Type I Anterior Rectocele
Condition: Rectocele
MeSH terms: Rectocele
Study type: Interventional

Summary: 
      Comparison between transperineal repair of rectocele with or without posterior internal
      sphincterotomy.
    

Detailed description: 
      Transperineal repair of anterior rectocele is performed in two groups of patients, the first
      will undergo limited posterior internal sphincterotomy, the second group will not have
      internal sphincteroromy. The two groups are compared regarding recurrence of rectocele and
      improvement of symptoms.
    

Intervention name(s): Transperineal repair with PIS; Transperineal repair without PIS
Intervention type(s): Procedure; Procedure
Intervention description(s): Repair of anterior rectocele via transperineal approach followed by limited internal sphincterotomy at 6 o'clock.; Repair of anterior rectocele via transperineal approach without performing limited internal sphincterotomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Seizure Detection and Warning System in Epilepsy Patients
Condition: Epilepsy; Generalized Tonic-Clonic Seizures
MeSH terms: Epilepsy; Seizures
Study type: Observational

Summary: 
      This is a phase III, pilot, prospective study of an Electromyography (EMG) based seizure
      detection system for detecting Generalized Tonic-Clonic Seizures (GTCS) in the home.
    

Detailed description: 
      The Brain Sentinel™ Seizure Detection and Warning System is intended for monitoring children
      and adults with a history or significant risk of generalized tonic-clonic seizures in the
      home or healthcare facilities, during the titration or withdrawal of anti-epileptic drugs,
      and for continuous monitoring (night time or any other time of day) of individuals due to
      their history or risk of generalized tonic-clonic seizures. The device will withstand
      activities of daily living including showers and sleep.
    

Intervention name(s): Brain Sentinel Seizure Detection and Warning System
Intervention type(s): Device
Intervention description(s): A sEMG based automated seizure detection and warning system worn on the biceps
Other intervention name(s): SPEAC System
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with a history of GTC seizures, either primary GTC or partial onset seizures with
        secondary generalization
Effect of Shock Wave Therapy on Truncal Obesity and Lipid Profile in Obese Post Menopausal Women
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This study aimed to evaluate the effect of six weeks extracorporeal shockwave therapy (SWT)
      on truncal obesity and serum lipids in obese postmenopausal women
    

Detailed description: 
      Truncal obesity occurs when the excess abdominal fat around the stomach and abdomen has
      accumulated to the point where it is likely to have a negative influence on health ,
      increased visceral abdominal fat (VAF) is directly related to abdominal obesity (AO), which
      is also linked to endothelial dysfunction, inflammation, insulin resistance, diabetes
      mellitus, hypercholesterolemia, hepatic steatosis metabolic syndrome [MetS] and cancer.

      High density lipoprotein (HDL) cholesterol, often known as cardio protective cholesterol,
      increases in a hypoestrogenic state such postmenopausal status, whereas triglyceride (TG),
      total cholesterol, and LDL cholesterol levels fall The prevention of CVD and dyslipidemia
      depends on the management of truncal obesity, and the reduction of serum lipid levels.

      Extracorporeal shock wave therapy (ESWT) has lately been popular for treating fat-related
      disorders by altering the permeability of lipocyte membranes, improving blood flow and
      hastening macrophages' clearance of debris so cellulite, body contouring and localized fat
      can all be treated with the safe and non-invasive ESWT technology because to its mode of
      action in biological tissue In order to identify the best methods for treating abdominal
      obesity and prevent the risk of developing cardiovascular disease (CVD) in post-menopausal
      women. The current randomized controlled trial aimed to determine the effect of
      extracorporeal shockwave therapy (SWT) on truncal obesity and serum lipids in obese
      postmenopausal women.
    

Intervention name(s): shock wave; Moderate intensity aerobic exercise; Energy-restricted diet
Intervention type(s): Device; Other; Other
Intervention description(s): ESWT (Chattanooga, Intelect RPW, USA) continues mode, hand piece transmitter R SW D20 /20mm, with the following Parameter: Shock pressure of 3-4 bars, wave frequency of 12 Hz.; Treadmail training exercise 60%-75% of Maximum heart rate MHR 2 times/ week; energy intake was 500K calorie below daily requirements on average three meals at the same time of the day
Other intervention name(s): Extracorporeal shock wave therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity-menopause-shock wave-lipid profile
Myopia Control With Simultaneous Vision Approach
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine if the 'Defocus Incorporated Soft Contact' (DISC) lens slows myopia progression
      in Hong Kong schoolchildren using simultaneous vision approach.
    

Detailed description: 
      The investigators hypothesize that the natural process of emmetropization in human is
      regulated by the equilibrium between the opposite hyperopic and myopic defocus. A sharp focus
      of retinal image (foveal fixation) is fundamental for co-ordination of the equilibrium. The
      DISC lens is a custom-made multi-zone bifocal soft contact lens which is based on
      simultaneously provides clear vision and defocus at all viewing distances. It comprises of
      correcting zones for correcting distant prescription(correction of refractive error, and
      defocusing zones to incorporate constant myopic defocus for slowing down myopia progression.
    

Intervention name(s): Defocus Incorporated Soft Contact (DISC) lens
Intervention type(s): Device
Intervention description(s): Use of simultaneous vision bifocal soft contact lenses with myopic defocus to control the progression of myopia
Other intervention name(s): myopia control; myopia progression; Simultaneous vision; bifocal contact lens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Myopia progression; Myopia control; Simultaneous vision; Myopic defocus
The Effect of Oxytocin on the Gastric Emptying
Condition: Postprocedural Delayed Gastric Emptying
MeSH terms: Gastroparesis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The investigators are going to examine whether oxytocin has a prokinetic effect on gastric
      emptying in patients suffering from gastro paresis. Oxytocin infusion will be compared with
      sodium chloride infusion.
    

Detailed description: 
      The investigators are going to examine whether oxytocin has a prokinetic effect on gastric
      emptying in patients suffering from gastro paresis. Oxytocin infusion will be compared with
      sodium chloride infusion.The gastric emptying is estimade by sitntigraphy during 70 minutes,
      and performed twicw. Once with saline and once with oxytocin.
    

Intervention name(s): oxytocin; oxytocin
Intervention type(s): Drug; Drug
Intervention description(s): 80mIE/min as continuous infusion for 70 minutes; 80 mU/ min of oxytocin infusion for 70 min along with measuring the gastric emptying by ventricle scintigraphy
Other intervention name(s): syntocinon; syntocinon
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: oxytocin; gastroparesis; diabetics; The effect of oxytocin on gastric emptying
Can Ultrasound Detect Diabetic Peripheral Neuropathy?
Condition: Distal Symmetric Polyneuropathy (DSPN)
MeSH terms: Peripheral Nervous System Diseases; Polyneuropathies
Study type: Observational

Summary: 
      The cross sectional area of posterior tibial nerve (PTN) is increased in diabetic patients
      with distal symmetric polyneuropathy (DSPN) as compared to diabetic patients without DSPN.
      This study aims to evaluate whether the cross sectional area of the Posterior Tibial Nerve
      (PTN) as measured by ultrasound is increased in patients with distal symmetric polyneuropathy
      (DSPN) as compared to diabetic patients without DSPN.
    

Detailed description: 
      Regional anesthesia is associated with a low frequency of neurologic injury that can result
      in permanent deficit. It is believed that patients with neuropathies might be at higher risk
      of injury but detailed investigation of the diabetic patient is lacking yet anesthetic
      practices may be altered nevertheless. This study intends to investigate the appearance and
      sonographic qualities, as well as electrophysiologic measures, of the posterior tibial nerve
      (PTN) in diabetic patients undergoing nerve conduction studies in order to compare PTN
      characteristics between diabetic patients with peripheral neuropathy to those without.
      Ultimately, we hope that ultrasound, a commonly used non-invasive tool, will be able to
      assist in the identification of patients at higher risk of injury from regional anesthesia
    

Intervention name(s): Nerve Conduction Study (NCS)
Intervention type(s): Procedure
Intervention description(s): An NCS will be performed on each patient to confirm or exclude DSPN. Following this, a systematic ultrasound examination of the posterior tibial nerve will be performed for all the patients.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        100 adult diabetic patients scheduled to undergo a nerve conduction study.
      
Keywords: distal symmetric polyneuropathy; diabetic peripheral neuropathy; posterior tibial nerve; regional anesthesia; nerve conduction study
RNActive® Rabies Vaccine (CV7201) in Healthy Adults
Condition: Rabies
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to assess the safety and immunogenicity of an investigational
      RNActive® rabies vaccine (CV7201) in healthy adults.
    


Intervention name(s): CV7201 mRNA
Intervention type(s): Biological
Intervention description(s): CV7201 is composed of 1 RNActive® mRNA that encodes the rabies virus glycoprotein.
Other intervention name(s): CV7201 messenger RNA; CV7201 RNActive®
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Rav G protein; rabies; VNT; immunogenicity; PrEP vaccination; mRNA; CV7201
Non-systemic Treatment for Patients With Low-volume Metastatic Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Prostate cancer patients diagnosed with a biochemical recurrence and limited metastases are
      conventionally treated with androgen deprivation therapy. However, in patients with limited
      metastatic load, the time to progression might be. Subsequently, active surveillance of these
      patients until progression might defer the start of androgen deprivation therapy (ADT) for
      several months to years. As an alternative, salvage treatment of the limited number of
      metastases with either surgery or radiotherapy might postpone the start of ADT even longer.
      The current trial hypothesizes that ADT might be deferred longer following salvage treatment
      as compared to active surveillance.
    


Intervention name(s): Surveillance; Salvage treatment
Intervention type(s): Procedure; Procedure
Intervention description(s): Active clinical surveillance; Surgical removal of metastases, or stereotactic body radiotherapy of metastases.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Guanfacine Clinical Trial for Smoking Cessation
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 2

Summary: 
      Adult daily smokers motivated to quit smoking will be randomized to extended-release
      guanfacine (6mg/day) or placebo and will enroll in an 8-week treatment period combining
      medication with brief behavioral support. The investigators hypothesize that the active dose
      of guanfacine compared to placebo will increase rates of prolonged smoking abstinence at the
      end of the 8-week treatment phase.
    


Intervention name(s): Guanfacine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 6mg/day ER with 3-week lead-in period. Maintained at steady state throughout 8 week treatment phase. After treatment phase, given taper supply of medication. Follow up at 1 month, 2 months and 6 months.
Other intervention name(s): Intuniv
Intervention MeSH terms: Guanfacine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Smokers; Quit Smoking; Treatment; Guanfacine