bioihbjkbjnl/mcl2 huggingface dataset:
Itraconazole Oral Absorption
Condition: Fungal Infection
MeSH terms: Mycoses
Study type: Interventional
Phase: Phase 4

Summary: 
      For tablets to be absorbed, the drug must dissolve after being swallowed. Drugs with low
      solubility sometimes require the inert ingredients in tablets to help the drug dissolve after
      being swallowed. This study uses itraconazole as an example drug with low solubility.
      Itraconazole tablets with different inert ingredients and manufacturing will be administered
      to healthy volunteers to see if the different inert ingredients and manufacturing impact drug
      absorption.
    


Intervention name(s): fast itraconazole tablet; medium itraconazole tablet; slow itraconazole tablet; oral itraconazole solution
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 100mg dose; 100mg dose; 100mg dose; 100mg dose
Other intervention name(s): fast dissolving itraconazole tablet; medium dissolving itraconazole tablet; slow dissolving itraconazole tablet; commercial oral itraconazole solution
Intervention MeSH terms: Itraconazole; Hydroxyitraconazole; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Stretching With And Without Pressure Biofeeback In Patients With Postural Syndrome
Condition: Postural; Defect
Study type: Interventional

Summary: 
      Postural syndrome describes a variety of conditions in which repetitive or continued bad
      posture over a long period of time causes pain and reduced function in the muscles and
      joints.

      Improper posture can cause pain throughout the length of the spine from the neck to the
      pelvis. Modern sedentary style of living is one of the main reasons for postural
      abnormalities evident in modern society. The prolonged sitting hours required in most of the
      jobs, and educational setups can affect flexibility of soft tissues, especially two joint
      muscles. Bad posture while standing or walking, if left uncorrected, can worsen over time and
      lead to pain and dysfunction. Hamstring is a key component of flexibility in the human body
      and it is more prone to get tightened. Many reasons can lead to the development of hamstring
      tightness such as genetic predisposition, injury to muscle, and adaptive shortening due to
      some chronic condition. Short hamstring muscles, because of their attachments to the
      posterior leg and to the ischial tuberosity, may limit hip flexion ROM and induces posterior
      pelvic tilt and decreased lumbar lordosis, which can result in LBP The purpose of this study
      will be to find out the effects of stretching with and without pressure biofeedback unit
      (PBU) on hamstring muscle flexibility in patients with postural syndrome. The active knee
      extension (AKE) test will be used to determine the length of the hamstring muscles using a
      goniometer. A PBU will be used to maintain the anterior pelvic tilt position during active
      knee extension (AKE) test or stretching, by monitoring the pressure of airbag. Patients will
      be recruited into study by convenient sampling technique after that will be allocated to
      groups by simple random assignment. All participants will actively stretch three days per
      week for four weeks. After collecting data from defined study setting, data will be entered
      and analyzed by using Statistical Package for the Social Sciences (SPSS) for Windows
      software, version 25.
    


Intervention name(s): biofeedback; hamstrings stretching
Intervention type(s): Other; Other
Intervention description(s): Twenty nine (29) patients will be treated stretching of hamstring with pressure biofeedback.; Twenty nine (29) patients will be treated stretching of hamstring without pressure biofeedback.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pressure biofeedback unit,; Stretching Hamstring Muscles; Active Knee Extension Test
A Phase 2, Randomized, Double-blind, Placebo Controlled Dose Ranging Study of Repeat Doses of AA4500 for the Treatment of Edematous Fibrosclerotic Panniculopathy
Condition: Edematous Fibrosclerotic Panniculopathy (EFP)
MeSH terms: Edema
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the safety and effectiveness of repeat doses of AA4500 in the treatment of
      edematous fibrosclerotic panniculopathy (EFP) commonly known as cellulite in adult women.
    

Detailed description: 
      The Phase 2a study is a randomized, double-blind multiple-dose study that is expected to
      enroll approximately 144 women between the ages of 18 and 45 in the United States. Treatment
      effectiveness will be evaluated by investigator and patient assessments, as well as 3-D
      photographic imaging techniques. Once the safety and local tolerability profile from the
      first stage has been found to be acceptable subjects will be enrolled in stage 2. After an
      interim safety and local tolerability review was completed of all subjects in stage 1, it was
      determined that enrollment in stage 2 is acceptable and has been initiated.
    

Intervention name(s): Collagenase Clostridium Histolyticum; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): injectible intervention
Other intervention name(s): AA4500; Xiaflex; Xiapex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cellulite; dimple; orange peel; cottage cheese; mattress texture
Study of Acetaminophen (ACM) in Post-operative Dental Pain
Condition: Post Operative Dental Pain
MeSH terms: Toothache
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Dental Pain Study which will evaluate the analgesic onset, efficacy and safety of
      1000 mg acetaminophen as two Test acetaminophen 500 mg tablets, compared with commercial
      products of acetaminophen 1000 mg administered as two 500 mg caplets, and ibuprofen (IBU) 400
      mg following third molar (wisdom tooth) extraction.
    

Detailed description: 
      This is a single-dose, randomized, double-blind, triple-dummy, placebo- and active
      controlled, parallel-group study to evaluate the analgesic onset, efficacy, and safety
      profile of Test acetaminophen 1000 mg compared with two commercial products over a six-hour
      period after third-molar extractions. Subjects will undergo dental extraction of three or
      four third molars.
    

Intervention name(s): acetaminophen Tablet; acetaminophen Caplet; ibuprofen Liquid-filled capsule; Placebo Tablet; Placebo Caplet; Placebo Liquid-filled capsule
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 2 test acetaminophen 500 mg tablets; 2 commercial acetaminophen 500 mg caplets; 2 commercial ibuprofen 200 mg Liquid-filled capsules; 2 placebo tablets; 2 placebo caplets; 2 placebo Liquid-filled capsules
Other intervention name(s): Test ACM; Commercial ACM; Commercial IBU
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison Between Remifentanil Target-controlled Infusion and Dexmedetomidine Bolus Administration for Smooth Emergence From General Sevoflurane Anesthesia
Condition: Thyroid Neoplasm
MeSH terms: Thyroid Neoplasms
Study type: Interventional

Summary: 
      Remifentanil target-controlled infusion and dexmedetomidine single-dose administration are
      known to reduce airway response and haemodynamic stimulation during anaesthetic recovery. The
      investigators will compare the effects of two drugs on prevention of cough during emergence
      from general sevoflurane anaesthesia.
    


Intervention name(s): dexmedetomidine; Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): Fifteen minutes before the end of surgery, the first practitioner replace the syringe of remifentanil as new one; new syringe contains remifentanil in remifentanil group (Group R), and normal saline in dexmedetomidine group (Group D), respectively. There are no drug labeling in the new syringe, so the second practitioner can't know which drug was contained in the new syringe. Simultaneously, the second practitioner remifentanil concentration on monitor of TCI pump will be adjusted to 2.0 ng•ml-1. Ten minutes before the end of surgery, 10 ml of dexmedetomidine 0.5 mcg•kg-1 mixed with normal saline will be given for 5 min in Group D; in Group R, 10 ml of normal saline will be given by the first practitioner.
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: dexmedetomidine; remifentanil; target-controlled infusion
Effect of the Consumption of a Fermented Milk on Common Infections in Children Aged 3-6 Years, Attending Day Care Centers
Condition: Common Infectious Diseases
MeSH terms: Infections; Communicable Diseases
Study type: Interventional

Summary: 
      This multicentric, randomized, double-blind and controlled study aims to examine the effect
      of a fermented dairy product containing the probiotic Lactobacillus casei DN-114 001
      (Actimel® = tested product) on the incidence of respiratory and gastro-intestinal common
      infectious diseases (cumulated number of infections during the intervention period: primary
      criteria) in children aged 3-6 years, attending day care centers.Volunteers received either
      200g/day of tested product (N=300) or control product (N=299) for 3-months, followed by a
      1-month follow-up.
    


Intervention name(s): 1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®); 2-Non fermented dairy product (control)
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Probiotic - Lactobacillus casei DN-114 001 - dairy; product - infections - children
Effect of Gait Training With a Walking Assist Robot on Gait Function and Balance in Elderly Adults
Condition: Gait, Unsteady; Healthy
MeSH terms: Gait Disorders, Neurologic
Study type: Interventional

Summary: 
      The purpose of this study was to investigate the effects of gait training with the new
      wearable hip assist robot developed by Samsung Advance Institute of Technology (Samsung
      Electronics Co, Ltd, Korea) in elderly adults.
    

Detailed description: 
      Eight elderly adults will participate in this study. All subjects will receive training 3
      times per week for 8 weeks for 24 training sessions. Each session is directed by a licensed
      physical therapist and lasted 60 min (including rest period of 10 min). Brain activity and
      gait assessment will be performed at visits 0 (baseline), 24 (post-test), and at 3 months
      (follow-up) after training.

      Primary objective is to demonstrate the effects of hip assist robot on spatio-temporal
      parameters measured by motion capture system (Motion Analysis Corporation, Santa Rosa, CA,
      USA), muscle activation patterns measured by surface electromyography (sEMG) (Noraxon Inc.,
      Scottsdale, AZ, USA), metabolic energy cost parameters measured by portable cardiopulmonary
      metabolic system (Cosmed K4B2, Rome, Italy) and cortical activation measured by functional
      Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany).

      Secondary objective is to demonstrate the effects of hip assist robot on motor function
      improvement evaluated by Short Physical Performance Battery Protocol and Score Sheet (SPPB),
      Berg Balance Scale (BBS), Dynamic Gait Index (DGI), Timed Up and Go (TUG) test, Push and
      Release (P&R) test, Functional Reach Test (FRT), Korean version Fall Efficacy Scale (K-FES),
      Manual Muscle Test (MMT) and Range of Motion (ROM).
    

Intervention name(s): Samsung Hip Assist v1
Intervention type(s): Device
Intervention description(s): All subjects receive gait training 3 times per week for 8 weeks for 24 training sessions. Each session is directed by a licensed physical therapist and lasted 60 min including rest period of 10 min. Brain activity and gait assessment is performed at visits 0 (baseline), 24 (post-test), and at 3 months (follow-up) after training.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Exoskeleton Device; Elderly; Gait rehabilitation
A Phase 1 Study to Compare the PK and Safety of Naproxcinod in Hepatic Impaired Patients and Matching Healthy Subjects
Condition: Liver Disease
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label study that will compare the pharmacokinetic and safety effects of
      naproxcinod in hepatic impaired patients vs. matching healthy subjects.
    

Detailed description: 
      This is an open-label, non-randomized, parallel-group study that will be conducted at two
      study sites. Patients with hepatic impairment and matched healthy subjects will receive
      naproxcinod 750 mg bid for 6 days and qd for the last day.
    

Intervention name(s): naproxcinod
Intervention type(s): Drug
Intervention description(s): 750 mg bid
Intervention MeSH terms: Naproxen-n-butyl nitrate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: hepatic impairment
Kin KeeperSM: Reducing Disparities Through Cancer Literacy and Screening
Condition: Breast Cancer; Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      1) To determine if the Kin KeeperSM Cancer Prevention Intervention increases first time and
      appropriately timed breast cancer screening rates among Black, Latina and Arab women; 2) To
      determine if the Kin KeeperSM Cancer Prevention Intervention increase first time and
      appropriately time cervical cancer screening rates among Black, Latina and Arab women; 3) To
      measure functional cancer literacy over time at the individual and familial level and 4)
      Assess rates of healthcare utilization cost among women in the Kin KeeperSM intervention and
      control-comparison groups.
    


Intervention name(s): Kin KeeperSM Cancer Prevention Intervention; Standard of care
Intervention type(s): Behavioral; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Breast & cervical cancer prevention & screening
Lidocaine Serum Levels in Healthy Adult Volunteers: a Pilot Evaluation of the J-Tip Delivery System
Condition: Healthy
Study type: Observational

Summary: 
      The J-Tip device (National Medical Products, Irvine, CA, USA) is a single-use, needle-free
      anesthesia delivery system, approximately 10cm long and weighing 9g that allow for the rapid
      delivery of lidocaine hydrochloride prior to peripheral venous access procedures. First
      introduced in 2001, it uses compressed carbon dioxide for drug delivery into the subcutaneous
      space. J-Tip is now approved by the U.S. Food and Drug Administration (FDA) for both children
      and adults.

      Designed for patients with needle anxiety and phobia, several clinical trials (Hollingsworth
      et al, 2000; Cooper JA et al, 2000) have shown the device to be effective with no significant
      untoward effects, including in children as young as 3 years old (Zempsky et al, 2008).
      However, two recent cases of toxic serum lidocaine levels in pediatric patients at
      Massachusetts General Hospital (MGH) following the use of the J-Tip device is concerning.
      Both patients were administered local anesthetic using the J-Tip device prior to needle-stick
      and toxicity screens returned with high levels of lidocaine (>6000 mcg/L).

      Currently, there is a limited amount of literature available on the safety profile of the
      J-Tip Delivery System and no study to date has evaluated serum lidocaine levels following its
      use, likely on the assumption that systemic absorption from the small amount of lidocaine
      within the device should be negligible. The two pediatric cases highlighted above, seem to
      suggest otherwise. The purpose of this pilot study is to assess the safety of the J-Tip
      device on a small population of healthy adults and to determine if elevated lidocaine levels
      are present systemically or locally. The primary outcome will be lidocaine serum levels
      following the administration of the J-Tip device measured at the local site and two distal
      sites to establish lidocaine serum levels following J-Tip administration. We expect lidocaine
      levels to be undetectable.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers over the age of 18.
      
Keywords: safety; J-Tip Delivery System; pharmacokinetic profile
Metabolic Surgery Versus Medical Management for Resolution of Type II Diabetes
Condition: Obesity; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Best medical management and gastric bypass surgery is a way to treat diabetes as part of
      regular medical care (standard of care). However, gastric bypass surgery is not a way to
      treat diabetes as part of regular medical care (standard of care).
    

Detailed description: 
      Best medical management and gastric bypass surgery are ways to treat obesity as part of
      regular medical care (standard of care). Best medical management is a way to treat diabetes
      as part of regular medical care (standard of care). However, gastric bypass surgery is not a
      way to treat diabetes as part of regular medical care (standard of care). But, studies
      suggest that diabetes gets better or goes away after gastric bypass surgery. This study is
      being done to find out if diabetes gets better or goes away completely after a patient has
      gastric bypass surgery as part of regular medical care (standard of care).
    

Intervention name(s): Laboratory evaluations, sleep study; Best Medical Management; Roux-en-Y gastric bypass surgery
Intervention type(s): Other; Other; Procedure
Intervention description(s): Fasting plasma glucose, liver function tests, chem-7, HOMA-IR, HBA1C, lipid profile, indirect calorimetry.; Standard of care.; Surgical treatment.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Obesity; Type 2 Diabetes Mellitus; Roux-en-Y Gastric Bypass Surgery
Hemodynamic Changes and Vascular Tone Control After Bariatric Surgery
Condition: Systemic Vascular Resistance
Study type: Observational

Summary: 
      Obese patients have increased cardiovascular risk and target organ damage (TOD) as compared
      to people with normal weight. Weight loss reduces cardiovascular risk and TOD. These changes
      have been associated mainly to changes in inflammatory and pro-atherogenic markers. Office
      peripheral blood pressure (BP) appears to decrease after bariatric surgery, but information
      on changes in 24h-ambulatory-BP-monitoring (24h-ABPM) and central-BP(cBP), or about the
      possible role of renin-angiotensin-aldosterone (RAAS), serotonin(STS) and
      endocannabinoid(ECS) systems is scarce. Our hypothesis is that the hemodynamic changes
      mediated by alterations in the RAAS, STS and ECS after weight loss are also responsible for
      the reduction of TOD.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients aged 18 - 65 years, who have medical indication for treatment with bariatric
        surgery and agreeing to undergo the intervention.
A Study to Investigate the Pharmacokinetic Interactions Between Simeprevir and Ledipasvir in a Treatment Regimen Consisting of Simeprevir, Sofosbuvir, and Ledipasvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the pharmacokinetic interactions between simeprevir
      and ledipasvir in a treatment regimen consisting of simeprevir (SMV), sofosbuvir (SOF), and
      ledipasvir (LDV) in treatment-naive participants with chronic hepatitis C virus (HCV)
      genotype 1 infection.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), 2-panel, Phase 2,
      randomized (study medication assigned to participants by chance) study. The study will
      consist of 3 study phases: Screening Phase (5 weeks), an Open-label Treatment Phase (70 days
      for Panel 1 and 56 days for Panel 2), a Post-treatment Follow-up Phase (12 weeks after the
      actual end of treatment). Participants will receive a combination of the following
      treatments: Treatment A: SMV 150 milligram (mg) once daily; Treatment B: LDV 90 mg along with
      SOF 400 mg once daily; Treatment C: SOF 400 mg once daily. Participants will be randomly
      assigned to Panel 1 (Treatment AC followed by Treatment AB) and Panel 2 (Treatment B followed
      by Treatment AB). The total study duration will be approximately 27 weeks for participants in
      Panel 1 and 25 weeks for participants in Panel 2. Participants will be primarily accessed for
      pharmacokinetic parameters. Participants' safety will be monitored throughout the study.
    

Intervention name(s): Simeprevir (SMV); Ledipasvir (LDV); Sofosbuvir (SOF)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive 150 milligram (mg) of SMV (Treatment A) once daily in Panel 1 and Panel 2.; Participants will receive 90 mg of LDV once daily as FDC tablet with SOF (Treatment B) in Panel 1 and Panel 2.; Participants will receive 400 mg of SOF alone (Treatment C) in Panel 1 and as FDC tablet with LDV (Treatment B) once daily in Panel 2.
Intervention MeSH terms: Sofosbuvir; Ledipasvir; Simeprevir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hepatitis C, Chronic; Simeprevir; Ledipasvir; Sofosbuvir
Evaluation of Pulp Response to Castor Oil
Condition: Pulp Response to Castor Oil
Study type: Interventional

Summary: 
      The present study was conducted to evaluate and compare pulp response to Castor oil versus
      Formocresol as Pulpotomy Medicaments in Primary Teeth
    


Intervention name(s): Castor oil; Formocresol
Intervention type(s): Drug; Drug
Intervention description(s): Procedure :pulpotomy procedure and histological evaluation. A sample of sixty two primary teeth from thirty healthy cooperative children of both sexes who were between 7-9 years and referred to Pediatric Dentistry Department. Two sound teeth without pulpotomy procedure were extracted and subjected to histological procedures to examine the normal pulp tissue and tissue organization (Negative control). The pulpotomy procedure was performed in sixty primary teeth (by split mouth design).
group I treated with castor oil; Group II treated with formocresol
Intervention MeSH terms: Castor Oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment