bioihbjkbjnl/mcl2 huggingface dataset:
Training Intrinsic Foot Muscles
Condition: Muscular Weakness
MeSH terms: Muscle Weakness
Study type: Interventional

Summary: 
      The foot intrinsic muscles are increasingly targeted in foot and ankle rehabilitation. The
      exercises are often difficult to learn initially. The purpose of the proposed study is to
      examine the effect training the intrinsic foot muscles on performance in selected physical
      and functional measures such as balance, plantar pressure during gait, vertical jump, and
      foot posture. In addition,the investigators will compare one group training with traditional
      exercise instruction methods and one group using an adjunctive modality (neuromuscular
      electric stimulation) during the introductory phases of exercise instruction. The
      investigators are interested in how this modality might affect physical and functional
      outcome measures and if it affects participants' frustration with learning a new exercise.
    

Detailed description: 
      Arm 1: The purpose of this arm of the study is to determine if a 4-week trial of foot muscle
      exercises, instructed with passive, active-assisted, and active techniques, affect functional
      measures such as balance, plantar pressure during gait, and vertical jump. A frustration
      index will be employed to assess participant frustration with learning a new exercise. 15
      will be enrolled in this arm of the study.

      Arm 2: The purpose of this arm of the study is to determine if a 4-week trial of foot muscle
      exercises, instructed with neuromuscular electric stimulation (NMES) and active techniques,
      affect functional measures such as balance, plantar pressure during gait, and vertical jump.
      A frustration index will be employed to assess participant frustration with learning a new
      exercise.15 will be enrolled in this arm of the study.

      Arm 3: This group will not engage in any training, but will serve as a comparator for the two
      intervention arms.
    

Intervention name(s): Short foot exercise protocol; Short foot exercise plus NMES
Intervention type(s): Other; Other
Intervention description(s): Exercises that target intrinsic foot muscles; Exercises that target intrinsic foot muscles supplemented by NMES for muscle re-education
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial with two intervention arms and one control arm
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Therapeutic exercise
Phase III Randomized Study of Ursodiol With Vs Without Methotrexate for Primary Biliary Cirrhosis
Condition: Liver Cirrhosis, Biliary
MeSH terms: Liver Cirrhosis; Liver Cirrhosis, Biliary; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      OBJECTIVES: I. Compare the effects of ursodiol (ursodeoxycholic acid), with and without
      methotrexate, on pruritus, incapacitation index, and serum markers of activity and severity
      in patients with primary biliary cirrhosis.

      II. Compare the effects of these regimens on the development of ascites, encephalopathy,
      varices (or bleeding from pre-existing varices), histologic liver changes, transplantation,
      and survival.

      III. Compare the toxicity and safety of each regimen.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by
      participating institution and Ludwig histologic stage.

      All patients are treated with ursodiol (ursodeoxycholic acid, UDCA) for 6 months. If entry
      criteria continue to be met, patients are randomly assigned to UDCA/methotrexate or
      UDCA/placebo.

      Combination therapy continues for at least 5 years.
    

Intervention name(s): methotrexate; ursodiol
Intervention type(s): Drug; Drug
Intervention MeSH terms: Methotrexate; Ursodeoxycholic Acid
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: cirrhosis; gastrointestinal disorders; primary biliary cirrhosis; rare disease
A Study of Fluzoparib Given in Combination With Apatinib in Ovarian or Breast Cancer Patients
Condition: Ovarian Cancer; Triple Negative Breast Cancer
MeSH terms: Breast Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Triple Negative Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Fluzoparib is an oral potent, selective poly-ADP ribose polymerase-1 (PARP-1) and PARP-2
      inhibitor; Apatinib is an oral selective vascular endothelial growth factor receptor (VEGFR)
      inhibitor. This open-label, dose finding phase I trial studies the tolerability and the best
      dose of fluzoparib in combination with apatinib and to see how well these two drugs work
      together in the treatment of patients with recurrent ovarian cancer or triple negative breast
      cancer. The safety and efficacy of fluzoparib in combination with apatinib will be explored.
      Both dose escalation and dose expansion parts are included in this study.
    


Intervention name(s): Fluzoparib; Apatinib
Intervention type(s): Drug; Drug
Intervention description(s): Fluzoparib either at 40,60,80mg twice daily,capsule oral.; Apatinib at 250mg once daily, tablet oral
Other intervention name(s): SHR3162; HS10160
Intervention MeSH terms: Apatinib; Fluzoparib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PARP inhibitor; VEGFR inhibitor; Combination therapy; Ovarian Cancer; Triple Negative Breast Cancer
Accuracy of Oximeters With Hypoxia and Methemoglobin or Carboxyhemoglobin
Condition: Healthy Volunteers
MeSH terms: Hypoxia
Study type: Observational

Summary: 
      Accuracy of the oximeter.
    

Detailed description: 
      The conventional pulse oximeter has been a standard in clinical care for non-invasive
      hemodynamic monitoring, which only measures the arterial blood oxygenation. There are many
      clinical situations where tissue hypoxia may exist despite normal values obtained by
      conventional pulse oximeter. This can be cause by inadequate monitoring of oxygen demand
      (i.e. venous oxygen saturation) of the tissues.

      The existing method for venous blood oxygenation monitored is either through an invasive
      fiber optic catheter, or intermittently by blood sampling and CO-oximetry. However,
      catheterization can be costly and can include inherent risks. Therefore, due to the inherent
      risks of catheterization, venous oximetry is limited only to those critically ill patients.
      The clinical application of venous oximetry is numerous, including severe sepsis and septic
      shock, severe trauma and hemorrhagic shock, and heart failure and cardiac arrest.

      More complete information on patient hemodynamics can be provided by non-invasively
      monitoring of venous blood oxygenation.
    

Intervention name(s): Mespere Oximeter; Radiometer OSM-3 Co-Oximeter
Intervention type(s): Device; Device
Intervention description(s): Mespere oximeter provides non-invasive venous blood oxygen saturation.; OSM-3, a Radiometer manufactured hemoximeter, is intended for the photometric determination of hemoglobin.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers between the ages of 21 and 49 years of either gender, and a range of
        skin tones
      
Biospecimen description: 
      Whole blood
Postoperative Respiratory Monitoring After Neuraxial Opioid Administration for Cesarean Delivery
Condition: Respiratory Depression
MeSH terms: Respiratory Insufficiency
Study type: Observational

Summary: 
      Respiratory depression occurs in labor and delivery; noticeably when neuraxial opioids are
      given.Pathophysiological respiratory depression -failure to respond to hypercapnia or hypoxia
      - is challenging to measure clinically.American Society of Anesthesiologist guidelines
      recommend suitable respiratory monitoring for 24 hours post cesarean delivery (CD).

      Use of capnograph will enable us to assess breath-by-breathe respiration in a population
      receiving neuraxial opioids - potentially at risk for respiratory depression.

      Our aim is to assess our ability to capture maternal postpartum respiratory parameters in a
      cohort following opioid neuraxial administration for CD.
    

Detailed description: 
      The investigators wish to test the efficacy of capnograph in detection of apnea and
      respiratory depression in women following cesarean delivery. Currently, routine intensive
      monitoring such as the investigators propose is not performed, and many apneas may go
      undetected.
    

Intervention name(s): Capnostream
Intervention type(s): Device
Intervention description(s): The Capnostream capnograph (is registered with the FDA) is supplied by Covidien. The Capnostream is a portable CO2 monitor with a pulse oximetry module to measure and record SpO2 (oxygen saturation) and heart rate continuously. The Capnostream provides waveform patterns for respiratory rate and EtCO2 measurement.
Other intervention name(s): Capnograph
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women undergoing cesarean delivery with neuraxial anesthesia.
      
Keywords: Postoperative Respiratory Monitoring; Neuraxial Opioid Administration for Cesarean Delivery
Tetracycline-Derivatives for Treatment of Cerebral Arteriovenous Malformations and Aneurysms
Condition: Aneurysms; Arteriovenous Malformations
MeSH terms: Hemangioma; Intracranial Arteriovenous Malformations; Aneurysm; Arteriovenous Malformations; Congenital Abnormalities
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this pilot study is to investigate the use of minocycline and doxycycline as
      medical therapy for inoperable or partially treated arteriovenous malformations (AVMs) and
      giant aneurysms.
    

Detailed description: 
      Arteriovenous malformations (AVMs) are a treatable cause of stroke in young adults. The
      processes by which AVMs and giant aneurysms grow in size and spontaneously bleed are unknown.
      The primary reason to treat AVMs and aneurysms is to guard against intracranial bleeding.

      This pilot study will examine the use of two common antibiotics-minocycline and
      doxycycline-as medical therapy for inoperable or partially treated AVMs and giant aneurysms.
      These drugs, which are tetracycline derivatives, can reduce the levels of a family of
      enzymes, called matrix metalloproteases, that degrade tissue and thereby cause a reduction in
      the risk of spontaneous bleeding from AVMs or aneurysm-which is the main cause of stroke
      associated with these disorders. The enzymes can contribute to weaknesses in the wall of
      blood vessels and may increase the risk of the vessel wall rupturing and causing spontaneous
      bleeding.

      This trial also will show that taking minocycline and doxycycline over an extended period in
      this patient population is safe and well tolerated. Results from this study could help plan
      future studies to benefit patients with abnormal blood vessels prone to bleeding in their
      brains.
    

Intervention name(s): minocycline; doxycycline
Intervention type(s): Drug; Drug
Intervention description(s): Take minocycline 50mg BID x2 years. Labs drawn at baseline, then every-6 months. MRI is done at baseline and completion of study.; Take doxycycline 50mg BID x2 years. Labs drawn at baseline, then every-6 months. MRI is done at baseline and completion of study.
Intervention MeSH terms: Doxycycline; Minocycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: giant aneurysms; arteriovenous malformations; minocycline; doxycycline; BAVM
To Demonstrate the Relative Bioavailability of Diclofenac Sodium 50 mg Enteric-Coated Tablets
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioavailability of Diclofenac Sodium 50 mg enteric-coated
      tablets.
    


Intervention name(s): Diclofenac Sodium 50 mg Tablets (Geneva Pharmaceuticals, Inc); Voltaren 50 mg Tablets (Geigy Pharmaceuticals)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anti-inflammatory
TAP Block vs Spinal Orphine for Postoperative Caesarean Section Analgetics
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this randomized controlled trial is to compare the effect of TAP block vs spinal
      morphine for post caesarean section analgesics. The main questions it aims to answer are:

        -  Which post op analgesic method works better for patients who underwent caesarean section

        -  The number of additional opioid needed
    


Intervention name(s): Transversus Abdominal Plane Block; Spinal Morphine
Intervention type(s): Procedure; Procedure
Intervention description(s): 20 cc of bupivacaine 0.2% was given to the transversus abdominis plane; 100 µg was administered intrathecally preoperatively
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Neuropeptide Y (NPY) Regulation of Nociceptors
Condition: Pain
Study type: Observational

Summary: 
      Neuropeptide Y (NPY) potently inhibits pain neurons in rats, but does this occur in human
      pain neurons? This hypothesis will be tested using microdialysis probes in patients who elect
      to have root canal treatment or extraction of thier tooth.
    

Detailed description: 
      The ongoing studies in rats indicate that a sympathetically-derived neuropeptide,
      neuropeptide Y (NPY), potently inhibits the activity of the capsaicin-sensative class of
      nociceptors (i.e., "pain" neurons). It is not know whether these results, generated from
      rodent studies, occur in human tissues under normal or inflamed conditions. We plan to test
      the hypothesis that NPY inhibits the initiation of neurogenic inflammation, as measured by
      reduced release of substance P, from capsaicin-sensitive class of petidergic neurons
      innervating normal and inflamed dental pulp. Such actions would be physiologically and
      clinically significant, since inhibition of exocytosis from peripheral terminals of
      nociceptive primary afferent fibers would likely alter neurogenic inflammation, local
      vasodilation and , possibly pain. Our research strategy takes advantage of a uniquely
      innervated tissue: dental pulp. Application of any physiologic stimulus to human dental pulp,
      including thermal, osmotic, chemical or mechanical, produces only pain. Thus, virtually all
      sensory neurons that innervate pulp appear to be nociceptors. Accordingly, application of
      drugs to pulpal sensory neurons targets a population of sensory neurons consisting
      predominantly of nociceptors.

      The research questions are as follows:

        1. Determine the capsaicin concentration-response curve from evoking the release of
           immunioreactive substance P (iSP) from normal and inflamed dental pulp.

        2. Determine the effect of NPY on altering basal and capsaisin-evoked release of iSP from
           normal and inflamed dental pulp.

      We will evaluate the hypothesis that NPY inhibits capsaicin-sensitive neurons in humans using
      microdialysis probes implanted into anesthetized dental pulp, with release of immunoreactive
      substance P (iSP) as our dependent measure. This study will include patients who have elected
      to have a root canal procedure performed or to have a tooth extracted.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Dental Patients
      
Keywords: Hyperalgesia; nociceptors; Neurons
Clinical Trial to Compare the Safety and Pharmacokinetics of YHP1604 in Comparison to the Co-administration of Telmisartan/Amlodipine and Rosuvastatin
Condition: Hypertension; Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, open label, single-dose, crossover study to investigate the
      pharmacokinetics of YHP1604 in comparison to the co-administration of telmisartan/amlodipine
      and rosuvastatin in healthy male volunteers

      Hypothesis: "YHP1604" and "telmisartan/amlodipine and rosuvastatin" are showing equal
      pharmacokinetics.
    

Detailed description: 
      This is a phase 1, open label, single-dose, crossover study to investigate the
      pharmacokinetics of YHP1604 in comparison to the co-administration of telmisartan/amlodipine
      and rosuvastatin in healthy male volunteers.

      In ARM1, 30 subjects will be assigned and the subjects will be administered
      "telmisartan/amlodipine and rosuvastatin" at Day1 and "YHP1604" at Day22.

      In ARM2, 30 subjects will be assigned and the subjects will be administered "YHP1604" at Day1
      and "telmisartan/amlodipine and rosuvastatin" at Day22.
    

Intervention name(s): Temisartan/Amlodipine+Rosuvastatin; YHP1604
Intervention type(s): Drug; Drug
Intervention description(s): All subjects will receive a single oral dose of temisartan/amlodipine+rosuvastatin administered in the morning.; All subjects will receive a single oral dose of YHP1604 administered in the morning.
Other intervention name(s): Twynsta Tab.+Crestor Tab.; FDC
Intervention MeSH terms: Amlodipine; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A randomized, open-label, single dose, crossover clinical trial
Masking: None (Open Label)
Primary purpose: Treatment
Investigation to the Mechanism of the Neuroplastic Modulation in Central Auditory Tract
Condition: Tinnitus; Neuromodulation; Electroacupuncture; Cochlear Diseases; Therapy
MeSH terms: Tinnitus; Cochlear Diseases
Study type: Observational

Summary: 
      Tinnitus is the awareness of sound or noise in the absence of acoustic stimulation. No
      definite therapeutic strategy of tinnitus has been developed yet. The current theory of
      tinnitus is the plasticity theory of neurophysiology model. Although acupuncture has its role
      in tinnitus treatment, its actual role still remains to be elucidated. Acupuncture has been
      proposed to induce the development of neuroplasticity. The aim of this project is to undergo
      a comprehensive investigation to the central auditory effect and the therapeutic effects of
      acupuncture in tinnitus. According the results of the preliminary studies, the objective
      auditory measurement and subjective tinnitus perception will be analyzed in tinnitus patients
      before and after acupuncture.
    

Detailed description: 
      Hearing loss is a common sensory deficit in human beings. Besides communication handicaps,
      hearing loss may associate with niggling tinnitus symptoms. Tinnitus is the awareness of
      sound or noise in the absence of acoustic stimulation. Tinnitus may cause bothersome problems
      in cognition, mood, or psychosocial behaviour and constitute a significant portion in the
      outpatient clinics of ENT practice. No definite therapeutic strategy of tinnitus has been
      developed yet. The current theory of tinnitus is the plasticity theory of neurophysiology
      model. According to this theory, several neuromodulation methods have been proposed such as
      repetitive transcranial magnetic stimulation (rTMS) or vagus nerve stimulation (VNS).
      Although acupuncture has its role in tinnitus treatment, its actual role still remains to be
      elucidated. Acupuncture has been proposed to induce the development of neuroplasticity. There
      are still few thorough researches to investigate the neurophysiological events after
      acupuncture. The aim of this project is to undergo a comprehensive investigation to the
      central auditory effect and the therapeutic effects of acupuncture in tinnitus. According the
      results of the preliminary studies, the objective auditory measurement and subjective tinn
      itus perception will be analyzed in tinnitus patients before and after acupuncture. The
      ultimate results of this project will clarify the basic central auditory effects of
      acupuncture and provide a potential for translational application of acupuncture to treat the
      common tinnitus patients.
    

Intervention name(s): Electroacupuncture
Intervention type(s): Other
Intervention description(s): insert the acupuncture needle to SJ3(left side) and connect the electroacupuncture device for 15min, 2mA and 2Hz
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Normal population
Effect of Cervical Spinal Stabilization Exercise Programs by Magnetic Resonance Imaging in Healthy Individuals
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of this study was to investigate the morphological changes in the neck muscles of
      cervical spinal stabilization exercises focused on flexor and extensor muscles applied to
      healthy individuals.
    

Detailed description: 
      In the prevention and treatment of cervical region pathologies, various exercise methods are
      applied in the clinic. The clinical exercises vary according to the time and severity of the
      pathology but also according to the pathology itself. These exercises include exercises
      focusing on flexor or extensor muscles. The aim of this study was to investigate the
      morphological changes in the neck muscles of cervical spinal stabilization exercises focused
      on flexor and extensor muscles applied to healthy individuals. At least 27 healthy male
      subjects between the age of 18-30 are planned to be included in the study. Individuals will
      be divided into 3 groups by simple randomization method. In one group cervical stabilization
      exercise program focused on the flexor muscles will be applied and the other group cervical
      stabilization exercise program focused on the extensor muscles will be applied for 8 weeks.
      Individuals in the control group will only be evaluated without exercise. In the study, by
      using magnetic resonance imaging (MRI) method as the main evaluation, muscle anatomical
      cross-sectional area and T2 relaxation time measurements will be made and morphological
      changes in muscles will be determined. These evaluation procedures will be performed on
      longus colli, sternocleidomastoid, semispinalis cervicis, multifidus and upper trapezius
      muscles. As additional evaluation methods, muscle strength and muscle endurance tests, normal
      joint motion measurements, posture evaluation and MRI measurement of cervical spine curvature
      will be performed. All evaluations will be performed at the beginning and at the end of these
      8 weeks and the effects of the exercises applied on the muscles in the two groups will be
      examined.
    

Intervention name(s): Exercises focused on flexor muscles; Exercises focused on extensor muscles
Intervention type(s): Other; Other
Intervention description(s): Exercises emphasis flexor muscles.; Exercises emphasis extensor muscles.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cervical spinal stabilisation exercises; muscle cross sectional area; muscle t2 relaxation time