bioihbjkbjnl/mcl2 huggingface dataset:
Bioavailability Study of CoQ10 Formulations in Healthy Elderly Adults
Condition: Bioavailability of Coenzyme Q10
Study type: Interventional

Summary: 
      The single-center, randomized, open-label, three-period crossover bioavailability study will
      include 21 subjects who will test three CoQ10 formulations. Subjects will test 3 formulations
      of single dose CoQ10 within first 3 weeks to assess bioavailability, which will be followed
      with 2 weeks of continuous administration of one of study formulations to demonstrate and
      assesse multiple-dose profile of CoQ10.
    


Intervention name(s): Single dose intervention with Standard product (SP); Single dose intervention with Comparative product (CP); Single dose intervention with Investigational product (IP); Multiple dose intervention with Standard product (SP); Multiple dose intervention with Comparative product (CP); Multiple dose intervention with Investigational product (IP)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): hard capsules, 100 mg; soft-gel capsules, 100 mg; syrup, 100 mg; hard capsules, 100 mg - 14 days; soft-gel capsules, 100 mg - 14 days; syrup, 100 mg - 14 days
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Three-period crossover bioavailability study will include 21 subjects who will test three CoQ10 formulations. Subjects will test 3 formulations of single dose CoQ10 within first 3 weeks to assess bioavailability, which will be followed with 2 weeks of continuous administration of one of study formulations to demonstrate and assesse multiple-dose profile of CoQ10.
Masking: None (Open Label)
Primary purpose: Other
Keywords: coenzyme q10; single dose bioavailability; multiple dose bioavailability
CyberKnife for Unresectable Renal Tumors
Condition: Renal Cancer
MeSH terms: Kidney Neoplasms
Study type: Interventional

Summary: 
      This is a dose escalation study using the CyberKnife radiotherapy device for small surgical
      or medically untreatable renal tumors. Patients with renal tumors 5cms or less in diameter
      will be accrued onto this study. The ability of CyberKnife to ablate these renal tumors and
      maintain renal function with dose escalation will be assessed.
    

Detailed description: 
      The CyberKnife Robotic Radiosurgery System is a unique radiosurgical system capable of
      treating tumors anywhere in the body noninvasively and with sub-millimeter accuracy. The
      CyberKnife System delivers radiation using a precise targeting methodology allowing a focal
      treatment margin around the target, thus limiting the volume of adjacent tissue receiving
      high doses radiation. This in turn allows the delivery of high doses of radiation to the
      prostate over a short series of treatments.
    

Intervention name(s): Stereotactic radiation; CyberKnife Robotic Radiosurgery System
Intervention type(s): Radiation; Device
Intervention description(s): Dose escalation three consecutive treatments
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CyberKnife
Ultrasound Cavitation Versus Radiofrequency on Abdominal Fat
Condition: Healthy Diet
Study type: Interventional

Summary: 
      Overweight and obesity is prevalent among women of reproductive age (25-34 years) with 42%
      having a BMI > 25 kg/m2. Weight gain increases the risk of developing diabetes and
      cardiovascular disease. The amount of weight regain postpartum can shift women from the
      healthy weight category into the overweight or obese BMI categories. Purpose: This study was
      conducted to compare the effectiveness of ultra-sound Cavitation versus radiofrequency on
      abdominal fat thickness on postnatal women
    

Detailed description: 
      Fifty overweight primipara women at 6 months postnatally aged from 20-35 years, BMI (25-29.9)
      kg/m2 and have waist hip ratio (WHR) > 0.8. They were assigned randomly into 2 equal groups:
      Group (A) received ultra-sound cavitation40 KHz applied for 30 min, once time weekly for 8
      weeks. Group (B) received radiofrequency multi-polar 5MHZ applied for 30 min, once time
      weekly for 8 weeks. Both groups received the same diet program throughout the treatment
      period. All females in both groups were assessed through weight scale for body weight, tape
      measurement for waist/hip ratio and ultra-sonography for fat thickness of abdominal region
      before and after treatment
    

Intervention name(s): healthy diet
Intervention type(s): Other
Intervention description(s): balanced diet program which ranged from 1600 kcal to 2000 kcal/day, which was calculated in an individual basis for each woman according to her basal metabolic rate (BMR) for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Fifty overweight primipara women at 6 months postnatally aged from 20-35 years, BMI (25-29.9) kg/m2 and have waist hip ratio (WHR) > 0.8. They were assigned randomly into 2 equal groups: Group (A) received ultra-sound cavitation40 KHz applied for 30 min, once time weekly for 8 weeks. Group (B) received radiofrequency multi-polar 5MHZ applied for 30 min, once time weekly for 8 weeks. Both groups received the same diet program throughout the treatment period. All females in both groups were assessed through weight scale for body weight, tape measurement for waist/hip ratio and ultra-sonography for fat thickness of abdominal region before and after treatment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ultra-sound cavitation; Radiofrequency; fat thickness
Prediction of Neonatal Respiratory Distress Syndrome in Preterm Fetuses by Assessment of Fetal Lung Volume by Vocal and Pulmonary Artery Resistance Index a Pilot Study
Condition: Fetal Lung Volume of Preterm Fetuses Measured by VOCAL, PA-RI Measured by Pulsed Doppler
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      The investigators will measure fetal lung volume by VOCAL and pulmonary artery resistance
      index in preterm fetuses and correlating the results with postnatal respiratory distress of
      the preterm neonates.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant women at 28 to 34 weeks gestation
      
Keywords: FLV, VOCAL, PA-RI, preterm fetuses, RDS
Assessment of Whole Gut Transit Time Using the SmartPill Capsule
Condition: Constipation
MeSH terms: Constipation
Study type: Observational

Summary: 
      Our null hypothesis states that the two techniques (Sitzmarks radioopaque markers and
      SmartPill) are equivalent and is demonstrated if the study population shows a correlation of
      0.7 or higher.
    

Detailed description: 
      The purpose of the study is to measure total gastrointestinal transit time using SmartPill GI
      Monitoring System with pH.p Capsule and compare the transit time determined by capsule
      transit to the conventional radioopaque marker technique.

      Both techniques are simultaneously applied in normal and constipated adult populations.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with constipation referred to a tertiary motility center
      
Keywords: capsule; constipation; whole gut transit; colonic transit; gastric emptying; small bowel transit
The Efficacy and Safety of Palonosetron in Preventing the Gastrointestinal Reactions Induced by 3-day Highly Emetogenic Chemotherapy
Condition: Cancer
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to assess the efficacy and safety of palonosetron in preventing the acute and
      delayed emesis induced by 3-day highly emetogenic chemotherapy. A double-blind, crossover
      design is used and granisetron is the positive control.
    


Intervention name(s): Palonosetron; Granisetron; Dexamethasone; Cisplatin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Palonosetron 0.25mg d1,d3; Granisetron 3mg d1-3; Dexamethasone 10mg d1-3; 3-day chemotherapy regimens including cisplatin, cisplatin: 25mg/m2 d1-3
Intervention MeSH terms: Dexamethasone; Palonosetron; Granisetron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Clinical Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamic Effects of a Single Oral 10 mg BAY1101042 Tablet Dose in Men and Woman With Renal Impairment and in Healthy Subjects
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the pharmacokinetics of BAY1101042 in subjects with mild to severe renal
      impairment, stratified according to estimated glomerular filtration rate (eGFR) determined
      2-10 days prior to dosing, and age-, weight- and gender- matched healthy subjects and to
      assess the safety, tolerability, and pharmacodynamics of BAY1101042 after a single oral dose
      of a 10 mg BAY1101042 given as 5 mg modified release (MR) tablet.
    


Intervention name(s): BAY1101042
Intervention type(s): Drug
Intervention description(s): Single oral dose of 10 mg BAY 1101042 (given as 5 mg MR tablets)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficacy Study of Pre-emptive Etoricoxib for Postoperative Pain and Functional Outcome in Total Knee Arthroplasty
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to study the efficacy of pre-emptive etoricoxib in reducing
      post-operative pain and improving function outcome after a total knee arthroplasty.
    

Detailed description: 
      Total knee arthroplasty (TKA) is one of the most commonly performed orthopaedic surgeries
      worldwide and has proven to be a success in the treatment of end-stage osteoarthritic knees.
      TKA is associated with significant postoperative pain which may delay the patient's
      functional recovery and necessitate an increased use of opioid analgesias, which are
      themselves associated with significant adverse effects such as nausea and vomiting. The
      selective cycloxygenase (COX)-2 inhibitor rofecoxib was previously shown in a clinical trial
      in a paper by Buvanendran et al to reduce postoperative opioid requirement and improve
      clinical outcomes. Feng et al studied the use of a single dose of rofecoxib pre-operatively
      and its effect on inflammatory markers and postoperative pain. Rofecoxib has, however, been
      withdrawn from the market due to its association with cardiovascular side effects. Our
      current clinical practice in post-operative pain management constitutes post-operative
      etoricoxib but we hypothesize that pre-emptively administering etoricoxib pre-operatively
      would give an even greater benefit in terms of post-operative opioid usage, pain scores, and
      functional recovery in the first 2-3 days. To date, there has been no study investigating
      etoricoxib as a pre-emptive medication in patients undergoing total knee arthroplasty. We aim
      to conduct a study to test the efficacy of pre-emptive etoricoxib in reducing postoperative
      pain, opioid requirement and improving the rate of functional recovery.
    

Intervention name(s): Control; Etoricoxib
Intervention type(s): Drug; Drug
Intervention description(s): Given placebo; Given etoricoxib 120mg 24 hours preoperatively and 120mg 2 hours preoperatively
Intervention MeSH terms: Etoricoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Clinical Observation on Electrophysiology in Headache Patients With Myofascial Trigger Points
Condition: Myofascial Trigger Points
MeSH terms: Headache
Study type: Observational

Summary: 
      Through an observational, cross-sectional study, muscle activity was compared among 21
      subjects with episodic headache, 17 subjects with chronic headache and 17 age-matched healthy
      controls. Muscle activity was bilaterally tested with needle electromyography at rest status,
      targeting at myofascial trigger points (MTrPs) in the frontal, temporal, sternocleidomastoid
      (SCM), splenius capitis, splenius cervicis and trapezius of each subject. Headache
      characteristics (intensity, frequency and duration), McGill Pain Questionnaire (MPQ) and
      Digital Span (DS) scales were secondary outcomes. The correlation between muscle activity and
      headache characteristics was also analyzed.

      This study provides preliminary evidence of the relationship between muscle and the
      chronicity of headache.
    


Intervention name(s): Electromyography
Intervention type(s): Device
Intervention description(s): Muscle activity was bilaterally tested with needle electromyography at rest status, targeting at myofascial trigger points (MTrPs) in the frontal, temporal, sternocleidomastoid (SCM), splenius capitis, splenius cervicis and trapezius of each subject.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All the patients were recruited from the headache clinic of Neurology in the first
        affiliated hospital of Nanjing Medical University from January/2018 to October/2018. Their
        diagnosis of headache were made according to the third edition of International
        Classification of Headache Disorders (ICHD-III).
Influence of Muscle Relaxation With Rocuronium Bromide During General Anaesthesia on Muscle Trauma and Postoperative Analgetic Consumption in Patients With Total Hip Prosthesis Implantation
Condition: Muscle Relaxation; Muscle Trauma; Analgetic Consumption; Total Hip Replacement
MeSH terms: Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      The researchers want to investigate the effects of muscle relaxation with rocuronium bromide
      during general anaesthesia on muscle trauma (serum CK, CRP) and postoperative analgesic
      consumption in patients with total hip prosthesis replacement (general vs. spinal
      anaesthesia).
    


Intervention name(s): effect of muscle relaxation on muscle trauma, control group without relaxation
Intervention type(s): Procedure
Intervention description(s): effect of muscle relaxation on muscle trauma, control group without relaxation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Administration of Vaginal and Rectal Progesterone During FET Cycles
Condition: Infertility
MeSH terms: Infertility
Study type: Observational [Patient Registry]

Summary: 
      Observational study of reproductive outcome after frozen embryo transfer in HRT with vaginal
      and rectal progesterone.
    

Detailed description: 
      Cohort of patients treated with autologous blastocyst at the Fertility clinic Skive Regional
      Hospital in HRT cycle. Estradiol stimulation started on second cycle day and on day 12 - 20
      vaginal and rectal progesterone is added. Blastocyst transfer on 6th progesterone treatment
      day. Serum progesterone and hCG measurement 9 or 11 days after embryo transfer.
    

Intervention name(s): Progesterone
Intervention type(s): Drug
Intervention description(s): 6 mg estradiol and vaginal and rectal progesterone
Other intervention name(s): estradiol
Intervention MeSH terms: Estradiol; Progesterone
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Autologuos spare embryos from previous IVF/ICSI cycles.
      
Keywords: Progesterone; HRT; frozen embryo transfer
A Placebo-controlled Study of 2-day Pre-treatment With Fexofenadine in Seasonal Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a proof-of-concept study to demonstrate if a daily dose of a 2-days
      pre-treatment of Fexofenadine 180mg is effective in alleviating the AR symptoms and to assess
      the additional benefit to the patient in terms of preventing Allergic Rhinitis (AR) symptoms.

      The total study duration per participant is expected at least 4 months, depending on the
      timing of the screening visit. 5 visits are planned, screening, confirmation inclusion
      challenge, randomization visit, challenge and end of study visit.
    

Detailed description: 
      The end of the study is defined as the date of the last visit of the last participant in the
      study.

      A participant is considered to have completed the study if he/she has completed all visits of
      the study including Visit 5 (Day 5).
    

Intervention name(s): Fexofenadine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Fexofenadine oral tablet; Fexofenadine matching placebo oral tablet
Intervention MeSH terms: Fexofenadine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
RI-001 in Immunosuppressed Respiratory Syncytial Virus (RSV) Infected Patients at Risk of Lower Tract RSV Illness
Condition: Upper Respiratory Tract Infection; Lower Respiratory Tract Infection
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      RSV infections can develop into serious, life threatening conditions among immunocompromised
      patients. The objective of this study (ADMA 001) is to evaluate the safety and efficacy of
      RI-001 for the prevention of lower respiratory tract infections in immunocompromised patients
      identified as being infected with RSV in the upper respiratory tract.
    


Intervention name(s): RI-001; RI-001; RI-001
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Dose 1; Dose 2; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Transplant; Immunosuppression
A Study to Compare the Blood Levels of Albaconazole in Healthy Subjects Who Have Received a Single Dose of 400 mg Albaconazole as a Tablet Versus Albaconazole as a Capsule
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether albaconazole tablets and albaconazole
      capsules (single 400mg dose) act in the body in the same way over a period of time.
    

Detailed description: 
      The aim of this study is to compare the bioavailability of the formulation used in earlier
      clinical studies (albaconazole capsules) with the formulation intended for use in further
      development (albaconazole tablets). The study is also designed to assess the safety and
      tolerability of a single oral dose of albaconazole tablets (400 mg), and assess the
      bioequivalence of albaconazole tablets with albaconazole capsules.
    

Intervention name(s): Albaconazole tablet 400mg; Albaconazole 100mg capsules, then albaconazole 400mg tablet
Intervention type(s): Drug; Drug
Intervention description(s): Albaconazole tablet 400mg single dose, then four albaconazole capsule 100mg single dose; Four albaconazole capsule 100mg single dose, then albaconazole tablet 400mg single dose
Other intervention name(s): Albaconazole; Albaconazole
Intervention MeSH terms: Albaconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy Volunteers
Triamcinolone Levels in Cochlear Perilymph, Lateral Canal and CSF
Condition: Vestibular Schwannoma
MeSH terms: Neurilemmoma; Neuroma, Acoustic
Study type: Interventional
Phase: Phase 1

Summary: 
      Patients undergoing surgery of a vestibular schwannoma will be included in the study.
      Patients will receive triamcinolone acetonide 24h before surgery. During translabyrinthine
      surgery cochlear perilymph, perilymph from the semicircular canal and cerebrospinal fluid
      will be taken and analyzed for triamcinolone content. In patients undergoing middle fossa or
      retrosigmoid resection only cerebrospinal fluid will be taken and analyzed for triamcinolone
      acetonide level.
    

Detailed description: 
      Patients between 18 and 90 years undergoing surgery of a vestibular schwannoma will be
      included in the study. Patients will be offered an application of triamcinolone acetonide
      intratympanically on the day before surgery.

      During surgery samples will be taken to define how much triamcinolone acetonide enters into
      the perilymphatic fluid, the perilymph of the semicircular canals and CSF.

      Patients undergoing translabyrinthine surgery will undergoing labyrinthectomy during which
      samples of the semicircular canal can be taken. During translabyrinthine surgery nerve
      monitoring will be carried out using an intracochlear electrode. Before inserting the
      electrode perilymph of the cochlea can be taken. Immediately after opening the dura
      cerebrospinal fluid will be taken. Patients undergoing middle fossa or retrosigmoid resection
      of the vestibular schwannoma will not undergo sampling of the perilymph. In these patients
      cerebrospinal fluid will be taken to determine triamcinolone acetonide levels.
    

Intervention name(s): Triamcinolone Acetonide 40mg/mL
Intervention type(s): Drug
Intervention description(s): Intratympanic application of triamcinolone acetonide
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment