bioihbjkbjnl/mcl2 huggingface dataset:
Multiple Oral Doses of BIBR 1048 MS Solution in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess safety, pharmacokinetics and the effect of BIBR 1048 MS on coagulation parameters.
    


Intervention name(s): BIBR 1048 MS low; BIBR 1048 MS medium 1; BIBR 1048 MS medium 2; BIBR 1048 MS high; BIBR 1048 MS placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Dabigatran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness and Cost-effectiveness of the Energetic Program
Condition: Neuromuscular Diseases
MeSH terms: Neuromuscular Diseases
Study type: Interventional

Summary: 
      Fatigue is present in at least 60% of the patients with a muscle disease and can be the most
      disabling symptom. In combination with other impairments, this often results in low levels of
      physical activity and decreased social participation, leading to large societal costs.
      Energetic is a self-management group program aimed at improving participation and physical
      endurance in these patients. Our hypothesis is that Energetic results in improved
      participation and improved physical endurance, less experienced fatigue and better quality of
      life compared to usual care, without increasing health care costs.
    


Intervention name(s): Energetic; Control group
Intervention type(s): Behavioral; Other
Intervention description(s): Physiotherapy and occupational therapy aimed at reconditioning and social participation.; Usual care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Social Participation; Fatigue; Self-Management; Rehabilitation; Physical therapy; Occupational therapy; Group intervention; Exercise
A Comparison of Intranasal Midazolam and Nitrous Oxide (N2O) Minimal Sedation for Minor Procedures in a Pediatric Emergency Department
Condition: Conscious Sedation; Simple Lacerations Less Than 4 cm; Lumbar Punctures; Minor Incision Drainage of Abscesses Not Requiring Extensive Debridement
MeSH terms: Emergencies; Lacerations
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this project is to compare the sedative effects of intranasal midazolam
      versus inhaled nitrous oxide (N2O) for minor procedures in the pediatric emergency
      department. The primary outcome will be length of stay (LOS) in the emergency department (ED)
      stay for minor procedures. Secondarily the investigators will compare patient/family and
      provider satisfaction while using either intranasal midazolam or N2O for minimal sedation.
      The investigators hypothesize that the total length of stay for children undergoing minor
      procedures in the ED will be lower for N2O, as compared to intranasal midazolam. The
      investigators also hypothesize that patient/family and provider satisfaction will be higher
      with N2O and adverse effects will not differ between N2O and intranasal midazolam. Patients
      will receive either intranasal midazolam or N2O for minor procedures. Following the
      enrollment period, data will be analyzed and the two will be compared. Total length of stay,
      patient/family and provider satisfaction will be studied.
    


Intervention name(s): Nitrous Oxide; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): Nitrous oxide will be delivered in one of two ways, using the titration method or rapid infusion method. Which ever method is used will be recorded. When using the titration method, starting at 20%, nitrous oxide will be added in 10% increments every 60 seconds until the ideal level of sedation has been met (not to exceed 70% nitrous oxide). Using the rapid infusion method, after the proper flow rate has been achieved with oxygen, the flowmeter will be increased to obtain 50% concentration of nitrous oxide. After 2-3 minutes if the patient does not have adequate sedation, nitrous oxide concentration will be increased to 70%.; Intranasal midazolam with mucosal atomizer device administration will follow the Children's Hospital Colorado (CHCO) established policy 'Intranasal Administration (atomization) of Medications'. As per standard of care, each patient will receive a standardized dose of 0.4mg/kg (maximum dose of 10mg) of intranasal midazolam with the mucosal atomizer device for all procedures.
Other intervention name(s): N2O; Versed
Intervention MeSH terms: Midazolam; Nitrous Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Early and Systematic Screening in Chronic Neuropathy
Condition: Amyloid Neuropathies, Familial
MeSH terms: Peripheral Nervous System Diseases; Amyloid Neuropathies; Amyloid Neuropathies, Familial; Amyloidosis
Study type: Interventional

Summary: 
      TTR-FAP is a rare disabling inherited disorder that predominantly affects the peripheral
      nervous system and the heart. Due to an important phenotypic and genetic heterogeneity, the
      diagnosis is often delayed, preventing therefore early onset treatment. Our project is to
      evaluate the prevalence of TTR-FAP in a series of 130 patients with from chronic neuropathy
      of undetermined aetiology through a systematic screening of TTR mutations.
    

Detailed description: 
      Transthyretin familial amyloid polyneuropathy (TTR-FAP) is an autosomal dominant disorder,
      highly disabling and life-threatening, resulting of transthyretin (TTR) gene mutation.
      Clinically, TTR FAP is characterized by progressive sensorimotor and dysautonomic neuropathy,
      usually fatal within a few years. The disease prevalence is highly variable, with a large
      genotypic and phenotypic heterogeneity. Early and accurate diagnosis remains essential to
      propose early treatment. New pharmacotherapies have been developed, such as Tafamidis®, and
      many patients can avoid liver transplant formerly considered as the only therapeutic option.
      The prevalence of TTR-FAP disease has been previously estimated in series of patients with
      severe and progressive neuropathy, frequently leading to a delayed diagnosis. TTR-FAP is also
      easily suspected when neuropathy is associated with cardiac symptoms or dysautonomia.

      Currently, genetic testing of TTR-FAP is targeted and is only prescribed to patients in whom
      the first-line assessment recommended by the High Authority for Health (HAS) did not identify
      a cause, and on the basis of a worsening of symptoms. An early diagnosis in those cases would
      allow earlier treatment and monitoring. No data are available about the prevalence of TTR-FAP
      in populations of patients with from chronic neuropathy of unknown aetiology, through a
      systematic screening of TTR mutations.

      The diagnosis of TTR-FAP will be performed using standard procedures following international
      recommendations, requiring genetic analysis of the TTR gene.

      The patients with a diagnosis of TTR-FAP confirmed during this study will be seen for an
      additional visit in the Investigating Centre and proposed suitable follow up, treatment and
      care.
    

Intervention name(s): Systematic screening of TTR mutations
Intervention type(s): Genetic
Intervention description(s): The diagnosis of TTR-FAP requires genetic analysis using direct sequencing of TTR gene.The diagnosis of TTR-FAP will be performed using standard procedures following international recommendations, requiring genetic analysis of the TTR gene.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: proportion, TTR-FAP, study, neuropathy
Fluid Management for Cesarean Section II
Condition: Cesarean Section
Study type: Interventional

Summary: 
      Fluid management plays an essential role in cesarean section. In previous study (NCT00488111)
      the investigators found that prior-epidural anesthesia fluid management produced a more
      significant role in stabilizing the blood pressure and better prognosis after cesarean
      delivery than that of the posterior-anesthesia ones. Given epidural anesthesia has a time
      interval before reaching the best state of anesthesia, so the fluid management also has a
      relatively adequate time to resuscitation. In reality, spinal anesthesia is used popularly
      except for the epidural anesthesia, whereas spinal anesthesia would produce more significant
      fluctuation of the hemodynamics compared with the latter. Herein the investigators proposed
      whether the prior-spinal anesthesia fluid management also produced similar effect on
      hemodynamic characteristics to the epidural anesthesia.
    


Intervention name(s): Ringer's Lactate; Six percent hydroxyethyl starch
Intervention type(s): Drug; Drug
Intervention description(s): Ringer's Lactate 8 ml/kg was given intravenously before or after spinal anesthesia in cesarean section; Hydroxyethyl starch (6%) was given before or after spinal anesthesia in cesarean section
Other intervention name(s): Lactated Ringer's solution; HES/HAES
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Spinal anesthesia; Fluid therapy
A Single Center, Open-label, Randomized, Two-period Crossover Food Effect Study of Single Doses of Tivozanib (AV-951) in Healthy Subjects
Condition: Food Effect of Tivozanib in Health Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine the effect of food on the pharmacokinetics (PK) of a single dose of
      1.5 mg tivozanib in normal healthy subjects.
    

Detailed description: 
      This study will be an open-label, randomized, two-period, crossover PK food effect study of
      tivozanib administered orally at 1.5 mg. Subjects will be screened for eligibility up to 28
      days prior to entry into the study.

      For each of 2 study periods, subjects will be admitted to the clinical research unit (CRU) on
      the day before dosing and fast overnight (approximately 10 hours). On the morning of dosing
      for each of the 2 study periods, subjects will receive a single oral dose of 1.5 mg tivozanib
      in either the fasted or fed state. Subjects will remain at the CRU for at least 48 hours
      after administration of study drug for collection of serial blood samples for pharmacokinetic
      (PK) analysis and safety monitoring. Subjects will return to the CRU on an outpatient basis
      for collection of additional blood samples for up to 504 hours postdose.
    

Intervention name(s): tivozanib
Intervention type(s): Drug
Intervention description(s): tivozanib 1.5 mg capsule, 2 discrete single doses separated by 6-weeks
Other intervention name(s): AV-951
Intervention MeSH terms: Tivozanib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AV-951; tivozanib; healthy Subjects; food Effect; pharmacokinetics
Effect of Preoperative Diclofenac Potassium on Articaine Buccal Infitration Success
Condition: Pulpitis - Irreversible; Anesthesia, Local
MeSH terms: Pulpitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to assess the effect of preoperative Diclofenac Potassium (50 mg
      Cataflam) on the anesthetic success of buccal infiltration with 4% articaine with epinephrine
      1:200,000 in mandibular molars with symptomatic irreversible pulpitis.
    

Detailed description: 
      This study aims to evaluate the effectiveness of preoperative administration of Diclofenac
      Potassium (50 mg Cataflam) compared to placebo, one hour before treatment, on the anesthetic
      success of buccal infiltration with 4% articaine with epinephrine 1:200,000 in mandibular
      molars with symptomatic irreversible pulpitis. Patients with moderate-to-severe pre-operative
      pain are selected. Full medical and dental history will be obtained from all patients treated
      during this study by the operator. Clinical diagnosis of symptomatic irreversible pulpitis is
      to be confirmed. The primary outcome is success of buccal infiltration using articaine.The
      secondary outcomes are pain on injection. Patients will be recruited from the outpatient
      clinic of Endodontics at the Faculty of Oral and Dental Medicine, Cairo University.
    

Intervention name(s): Diclofenac Potassium 50mg Tab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A 50 mg tablet of the medication to be taken one hour before initiation of endodontic treatment.; A placebo will be taken one hour before initiation of endodontic treatment.
Other intervention name(s): Cataflam 50mg
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients will be randomly divided into 2 groups:
Experimental group:
Diclofenac Potassium (50 mg, Cataflam) to be administered one hour before treatment.
Control group:
Placebo to be administered one hour before treatment.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pulpitis, irreversible Pulpitis, Hot tooth; Cataflam, Diclofenac Potassium, Preoperative, Premedication, Analgesic; Local anesthesia, Articaine, Buccal infiltration
Transperineal Intraprostatic Injection of PRX302 Under Ultrasound Guidance for Management of Prostatic Hyperplasia
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether PRX302 is safe and effective in the
      treatment of moderate to severe Benign Prostatic Hyperplasia (BPH).
    

Detailed description: 
      This is a randomized, double-blinded, placebo-controlled study of transperineal
      intraprostatic injection of PRX302 under sonographic guidance. Subjects will be randomly
      assigned to the two treatment groups in a ratio of 2:1 between PRX302 and Placebo, stratified
      by prostate size and baseline IPSS.
    

Intervention name(s): PRX302; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): PRX302 will be administered at a volume equivalent to 20% of the prostate volume and at a fixed concentration. Treatment will be administered through 1 injection into the transition zone of each lobe of the prostate. A minimum of 2 deposits will be made in the transition zone into each of the right and left lobes of the prostate, with a minimum of 1.0 mL per deposit.; PRX302 will be administered at a volume equivalent to 20% of the prostate volume and at a fixed concentration. Treatment will be administered through 1 injection into the transition zone of each lobe of the prostate. A minimum of 2 deposits will be made in the transition zone into each of the right and left lobes of the prostate, with a minimum of 1.0 mL per deposit.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Benign Prostatic Hyperplasia; BPH; Enlarged Prostate
A Pilot Cross-over Bioequivalence Study of E3810 for Healthy Japanese Male (Under Postprandial Condition)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess pharmacokinetics of rabeprazole under postprandial
      condition.
    


Intervention name(s): rabeprazole; rabeprazole; rabeprazole; rabeprazole
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 10 mg normal tablet; Type 1 granule containing rabeprazole 10 mg; Type 2 granules containing rabeprazole 10 mg; Type 3 granules containing rabeprazole 10 mg
Intervention MeSH terms: Rabeprazole
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rabeprazole; Japan; healthy Japanese male
Deep Brain Stimulation for Voice Tremor: Left, Right, or Both Hemispheres?
Condition: Essential Voice Tremor; Deep Brain Stimulation; Essential Tremor; Laryngeal Diseases; Action Tremor; Tremor, Nerve
MeSH terms: Laryngeal Diseases; Tremor; Essential Tremor
Study type: Interventional

Summary: 
      Deep Brain Stimulation (DBS) is the gold standard treatment for Essential Tremor (ET). ET is
      a movement disorder which causes the arms, feet, fingers, head or voice to involuntarily
      shake. The DBS surgical procedure involves implanting an electrode deep within the brain
      which blocks damaging signals that cause the tremor. Essential Voice Tremor (EVT) is the
      vocal manifestation of ET and a number of individuals have both ET and EVT, and when these
      patients are implanted for their ET, their EVT symptoms are often also mitigated. This study
      aims to quantify the effects of DBS on EVT by testing on these ET+EVT patients. In addition
      to this, we hope to determine which hemisphere of the brain is responsible for larynx
      control: left or right.
    

Detailed description: 
      Essential Tremor (ET) is the most common movement disorder in adults, affecting approximately
      5% of individuals over the age of 65. Of this 5%, roughly 20% of these patients suffer from
      Essential Voice Tremor (EVT): the phonatory manifestation of ET. Patients with EVT lose their
      ability to speak due to a tremor in the muscles of the larynx, pharynx, palate, and tongue.
      Because of this, an individual's quality of life is limited because they can no longer
      communicate effectively.

      The purpose of this study is to quantify to what degree Deep Brain Stimulation improves
      Essential Voice Tremor. In addition to this, we hope to examine which brain hemisphere is
      responsible for these positive results: right, left, or both, in a prospective, randomized,
      double-blinded manner. By finding out more about the subcortical control underpinning speech,
      we will be able to improve our treatments and understanding of EVT and other neurological
      speech disorders.
    

Intervention name(s): Deep Brain Stimulation
Intervention type(s): Device
Intervention description(s): DBS System Medtronic
DBS programming settings will be set to maximally alleviate limb tremor, primary reason for referral
These settings will be used to evaluate effects of voice tremor as well
Other intervention name(s): DBS
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Deep Brain Stimulation; Laryngeal Motor Cortex; Essential Voice Tremor; Essential Tremor
Comparison of Immediate Versus Delayed Removal of Urinary Catheter Following Elective Cesarean Section
Condition: Urinary Catheter; Cesarean Section; Urinary Infection
MeSH terms: Urinary Tract Infections
Study type: Observational

Summary: 
      The objective this trial is to compare immediate and 12 hours postoperative removal of
      urinary catheter after elective cesarean section; and whether early removal is associated
      with lower risk of urinary infection compared with delayed catheter removal.
    


Intervention name(s): Foley urethral catheter
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Women admitted to the prenatal wards for primary or repeat elective cesarean section
Konjac-Mannan Improves Glycemia and Other Risk Factors for CHD in T2DM
Condition: Type2 Diabetes; Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      To examine whether Konjac-mannan fiber improves metabolic control measured by glycemia,
      lipidemia, and blood pressure in individuals with type-2 diabetes.
    


Intervention name(s): konjac glucomannan; wheat bran
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Konjac-mannan fiber-enriched biscuits (0.7 g/412KJ [100kcal] of glucommanan); Wheat bran (hard red wheat bran) fiber enriched biscuits
Intervention MeSH terms: (1-6)-alpha-glucomannan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: konjac; type2 diabetes; fiber; coronary heart disease
Trip Recovery Training Without a Specialized Treadmill
Condition: Accidental Fall
Study type: Interventional

Summary: 
      The goal of this study is to investigate the effects of a novel form of balance training
      called trip training. Trip training typically involves repeatedly exposing an individual to
      trip-like losses of balance on a specialized treadmill. This repeated exposure can lead to
      improvements in responses to trips while walking in the future, thereby reducing the risk of
      falling after a trip. Trip training typically is commonly conducted using a costly
      specialized treadmill. This study will evaluate the efficacy of a trip training protocol that
      does not require a treadmill. Adults age 65-80 will be assigned to either 1) non-treadmill
      trip training, 2) treadmill trip training, or 3) no intervention. The investigators
      hypothesized that responses to laboratory-induced trips would be better after non-treadmill
      trip training compared to no intervention, and that there would be no statistical difference
      between responses to laboratory-induced trips after non-treadmill trip training and treadmill
      trip training. The results from this work will advance the use of trip training, and may
      enable its wider use by establishing a protocol that does not require a costly treadmill.
    


Intervention name(s): non-treadmill trip training; treadmill trip training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants practice volitional and reactive stepping responses that mimic those needed when recovering balance after tripping.; Sudden treadmill changes in speed (from standing) induce trip-like losses of balance, after which participants take steps to recover balance and establish a stable gait pattern. This is repeated over a range of speeds to both provide training variability and to individualize training to each participant's capability.
Intervention MeSH terms: Triptorelin Pamoate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention