bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Fasting and Exercise on Insulin and GH Signaltransduction in Muscle and Fat
Condition: Healthy
Study type: Interventional

Summary: 
      Hypothesis: under fasting there will primarily be an activation of growth hormone(GH)
      signalpathways and a inhibition of insulin signalpathways, and the opposite will happen under
      physical activity.

      Primarily we will investigate markers for GH and insulin signaltransduction in muscle- and
      fat-biopsies after fasting for 72 hours and after 1 hour of ergometer-cycling at 65% Vo2max.

      In addition to this we will investigate the effect of fasting and exercise on the velocity of
      carbamide synthesis, aminoacid rate of turnover and glucose rate of turnover.
    


Intervention name(s): Exercise; Fasting
Intervention type(s): Other; Other
Intervention description(s): 1 hour ergometer cycling on 65% of Vo2max, and then the same as arm 1.; 3 days of fasting and then the same as arm 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: growth hormone insulin signaltransduction signalpathways; growth hormone and insulin signalpathways
Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Condition: Brain and Central Nervous System Tumors
MeSH terms: Glioblastoma; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in
      chemotherapy use different ways to stop tumor cells from dividing so they stop growing or
      die. It is not yet known if radiation therapy is more effective with or without temozolomide
      for glioblastoma multiforme.

      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or
      without temozolomide in treating patients who have newly diagnosed glioblastoma multiforme.
    

Detailed description: 
      OBJECTIVES: I. Compare the efficacy of radiotherapy with or without temozolomide in terms of
      overall survival in patients with newly diagnosed glioblastoma multiforme. II. Compare the
      toxicity profiles of these regimens in these patients. III. Compare the progression free
      survival of these patients treated with these regimens. IV. Compare the quality of life in
      these patients treated with these regimens.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      participating center, age (under 50 vs 50 and over), WHO/ECOG performance status (0-1 vs 2),
      and extent of surgical resection (biopsy only vs complete or incomplete resection). Patients
      are randomized to one of two treatment arms. Arm I: Patients undergo radiotherapy 5 days a
      week for 6 weeks. Arm II: Patients undergo radiotherapy as in arm I concurrently with oral
      temozolomide daily for 6 weeks. Patients then receive adjuvant oral temozolomide alone on
      days 1-5 every 28 days for 6 courses beginning 4 weeks after completion of radiotherapy.
      Quality of life is assessed prior to the study, at week 4 during radiotherapy, at 4 weeks
      after completion of radiotherapy, at the end of courses 3 and 6 of adjuvant chemotherapy (arm
      II), and then every 3 months until disease progression. Patients are followed every 3 months
      until disease progression or death.

      PROJECTED ACCRUAL: A total of 520 patients (260 per treatment arm) will be accrued for this
      study within 3.5 years.
    

Intervention name(s): temozolomide; radiation therapy
Intervention type(s): Drug; Radiation
Intervention MeSH terms: Temozolomide
Primary purpose: Treatment
Keywords: adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma
A Single Ascending Dose Study to Characterize the Pharmacokinetics, Safety, and Tolerability of SAR441566 in Healthy Adult Japanese Male Participants.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a cross-over, Phase 1, 3-treatment period single sequence study. The purpose of this
      study is to characterize pharmacokinetics (PK), safety, and tolerability of single ascending
      oral doses of SAR441566 in healthy male Japanese participants, 18-55 years of age.
    

Detailed description: 
      The duration of the study for a participant will be up to approximately 65 days.
    

Intervention name(s): SAR441566
Intervention type(s): Drug
Intervention description(s): Tablet
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalency Study of CM082 Tablet in Healthy Volunteers
Condition: Advanced Malignant Solid Tumors
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this study is to evaluate the bioequivalency of two preparations of
      CM082 tablet in Chinese healthy volunteers.
    

Detailed description: 
      The main objective of this study is to evaluate the bioequivalency of two preparations of
      CM082 tablet in Chinese healthy volunteers under fasted state or after meal. In addition, the
      safety of single dose administration of CM082 tablet in Chinese healthy volunteers will also
      be evaluated.
    

Intervention name(s): CM082 tablet (test product); CM082 tablet (reference product)
Intervention type(s): Drug; Drug
Intervention description(s): Test product(T)：100mg CM082 tablet manufactured by Betta Pharmaceuticals; Reference product(R)：100mg CM082 tablet manufactured by Catalent Pharma Solutions
Intervention MeSH terms: Vorolanib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Plasma Rich in Growth Factors on Semen Quality
Condition: Vascular Endothelial Growth Factor Overexpression
Study type: Observational

Summary: 
      The hypothesis is growing semen samples with plasma rich in growth factors (PRGF), because it
      could improve sperm motility in patients subsidiary TRA, ultimately improving pregnancy
      rates.
    

Detailed description: 
      Platelet growth factors are a group of proteins involved in cellular communication modifying
      biological responses. Obtaining plasma rich in growth factors is already widespread and
      simple protocol technique that is being used in various areas of medicine with superb
      results. Described many of the growth factors present in the PRGF are related to sperm
      parameters, especially motility The described effects have been studied in mammalian and each
      growth factor individually. PRGF contains a pool of growth factors and therefore be
      interesting to analyze their effect on various sperm parameters.

      One of those parameters is very important for fertilization sperm motility, since the lack of
      it will prevent displacement by the cervix to meet the egg in the fallopian tube.
    

Intervention name(s): PRGF in candidates for sperm donors
Intervention type(s): Biological
Intervention description(s): PRGF application on seminal aliquots will be conducted at different concentrations assessing sperm motility.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Prospective study of 58 candidates for sperm donors clinic IVI Bilbao.
Comparison of the Pharmacokinetic and Pharmacodynamic Biosimilarity of CHS-1701 (Coherus Pegfilgrastim) With Neulasta® (Pegfilgrastim)
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, single-dose, 2-period crossover study in healthy subjects
      to assess PK, PD, and safety (including immunogenicity) of a single 6 mg subcutaneous (SC)
      injection of CHS-1701 compared with a single 6 mg SC dose of Neulasta®.
    

Detailed description: 
      This is a randomized, double-blind, single-dose, 2-period crossover study in healthy subjects
      to assess PK, PD, and safety (including immunogenicity) of a single 6 mg subcutaneous (SC)
      injection of CHS-1701 compared with a single 6 mg SC dose of Neulasta®.

      After screening, eligible subjects will be randomly assigned to 1 of 2 treatment sequences;
      CHS-1701 followed by Neulasta® (Sequence A) or Neulasta® followed by CHS-1701, Sequence B).
      Treatments will be spaced by a minimum of 6 weeks apart (but no more than 8 weeks). Subjects
      will be admitted to the Clinical Pharmacology Unit (CPU) on Day -1 (Period 1) and will be
      confined through Hour 96 postdose (a total of approximately 4.5 days and 5 nights). Blood
      samples will be collected at specified time points postdose for plasma PK and PD measurements
      and the subjects will be closely monitored for safety. Following discharge on the morning of
      Day 5 (Period 1) subjects will return to the clinic for additional PK, PD and safety follow
      up--daily through Day 9 and at stated interval time points thereafter.

      The single dose of the alternate blinded study drug will be given after 6 (but no more than
      8) weeks of observation and washout and the above procedures will be repeated (Period 2). A
      Follow up Visit will take place 41 (±1) days after the second dose.
    

Intervention name(s): CHS-1701; Pegfilgrastim
Intervention type(s): Drug; Drug
Other intervention name(s): Neulasta
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Neurogenic Mechanisms in Burning Mouth Syndrome
Condition: Burning Mouth Syndrome
MeSH terms: Burning Mouth Syndrome; Syndrome; Burns
Study type: Interventional

Summary: 
      Burning mouth syndrome (BMS) is characterized by a bilateral burning sensation in the
      anterior tongue, hard palate and lips in the absence of any clinical or laboratory findings.
      The term syndrome implicates the simultaneous presence of oral dryness (xerostomia) and
      altered taste (dysgeusia) in addition to the burning sensation in the oral mucosa. BMS is
      most often seen in women and is more frequent during menopause. The etiology and pathogenesis
      are still unclear but recent studies suggest that BMS is a neuropathic pain condition.

      The objectives of the study are:

        -  To clarify potential neurogenic mechanisms behind BMS using immunohistochemistry (IH) to
           characterize the localization and distribution of peripheral nerve fibres, neuropeptides
           like substance P, calcitonin gene-related peptide, nerve growth factor, nerve growth
           factor receptor, PGP 9.5 neuronal marker and TRPV1 as well as inflammatory/structural
           changes.

        -  To perform a randomized double blind cross-over intervention study to examine the
           efficacy and safety of topical application of capsaicin oral gel (on the tongue) to
           relieve the burning sensation in patients with BMS.
    

Detailed description: 
      Data which support the hypothesis that BMS is a neuropathic pain condition include amongst
      others a recent clinically controlled study that has shown up-regulation of TRPV1-positive
      nerve fibres in tongue mucosa in patients with BMS. The vanilloid receptor-1 (TRPV1) is a
      voltage-dependent cation channel expressed by the unmyelinated C-nociceptive nerve fibres and
      the receptor may be activated by capsaicin (from chili peppers), heat and H+. Capsaicin binds
      to the TRPV1 receptor causing depolarization of the C-nociceptors. Prolonged activation of
      these neurons by capsaicin depletes pre-synaptic substance P and makes them unable to report
      pain.
    

Intervention name(s): Capsaicin oral gel 0.025%; Capsaicin oral gel 0.01%
Intervention type(s): Other; Other
Intervention description(s): Application 3 times daily for 14 days on the tongue, followed by 14 days wash-out; Application 3 times daily for 14 days on the tongue, followed by 14 days wash-out
Other intervention name(s): Capsicum, extract from chilipepper; Capsicum, extract from chilipepper
Intervention MeSH terms: Capsaicin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Burning mouth syndrome; neuropathy; inflammation; tongue mucosa; tongue innervation; dysgeusia
A Multi-Center Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients
Condition: Drooling
MeSH terms: Sialorrhea; Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine safety, tolerability and preliminary efficacy of intraglandular injections of
      MYOBLOC for the treatment of sialorrhea in Parkinsons' Disease patients
    

Detailed description: 
      This is a multi-center, outpatient, double-blind, placebo-controlled, single treatment,
      sequential dose escalation study designed to evaluate the safety, tolerability and
      preliminary efficacy of single doses of MYOBLOC versus placebo for the treatment of
      sialorrhea in Parkinson's disease patients, lasting approximately 20 weeks.
    

Intervention name(s): Botulinum Toxin Type B (Myobloc); Matched placebo to Myobloc
Intervention type(s): Biological; Biological
Intervention MeSH terms: rimabotulinumtoxinB; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Sialorrhea
Treatment of Idiopathic Membranous Nephropathy With Tripterygium Wilfordii Plus Steroid vs Tacrolimus Plus Steroid
Condition: Idiopathic Membranous Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, Membranous
Study type: Interventional

Summary: 
      The purpose of this study is: To explore the potential role of Tripterygium wilfordii plus
      steroid in the treatment of membranous nephropathy.

      To investigate the safety and tolerability of Tripterygium wilfordii plus steroid
    

Detailed description: 
      Idiopathic membranous nephropathy is the most common cause of nephrotic syndrome in adults.
      Over the past decade, a number of studies have reported therapeutic efficacy for treatment
      with tacrolimus plus steroid in patients with nephrotic syndrome including patients with
      membranous nephropathy. This study will evaluate the safety and effectiveness of a
      traditional herbal extraction, Tripterygium wilfordii, plus steroid in reducing the amount of
      protein in the urine in patients with membranous nephropathy. A hundred patients with
      biopsy-proven membranous nephropathy will be recruited. They will be screened with a medical
      history, physical examination, blood tests, and an examination for infection, cancers, and
      other conditions that can cause membranous nephropathy. The investigators plan to conduct an
      open-label study of the efficacy and safety of Tripterygium wilfordii in the treatment of
      membranous nephropathy. Half of them will be treated with oral Tripterygium wilfordii plus
      steroids for 6 months, followed by 6 months of maintenance, and the other half treated with
      tacrolimus plus steroid as positive contrast. Proteinuria, renal function will be monitored.
      Complete remission is defined as 24-hour urinary protein excretion to less than 0.4 mg/day
      and serum albumin>35g/L. This study will explore the potential role of Tripterygium wilfordii
      in the treatment of membranous nephropathy, it's cost less .
    

Intervention name(s): Tripterygium wilfordii; FK506
Intervention type(s): Drug; Drug
Intervention description(s): Tripterygium wilfordii 120mg/d Prednisone 30mg/d; capsule
Other intervention name(s): TW; Tacrolimus + Prednisone 30mg/d
Intervention MeSH terms: Prednisone; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Idiopathic Membranous Nephropathy; Treatment; FK506; Tripterygium wilfordii
Efficacy and Safety Assessment of Botulax® and BOTOX® for Improvement of Glabellar Lines.
Condition: Glabellar Lines
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a phase 3 clinical trial of multi-center, random, blinded*, parallel control,
      and positive control to evaluate the efficacy and safety of Botulax® Injection compared to
      BOTOX® for improving moderate to severe glabellar wrinkles.
    

Detailed description: 
      The case test of 500 qualified test subjects was conducted in 13 institutions nationwide in
      China. Those who meet all selection criteria and do not meet any of the exclusion criteria
      are selected as suitable test subjects. The selected test subjects are blinded and divided
      into the Botulax test group or the BOTOX test group.
    

Intervention name(s): Botulinum Toxin A type for injection (Botulax®); Botulinum Toxin A type for injection (BOTOX®, Bao Tuo Shi®)
Intervention type(s): Drug; Drug
Intervention description(s): Person in charge of dilution uses 0.9% sodium chloride injection solution to formulate the drug substance into 4U/0.1mL composite solution, and the investigator injects it into the test subjects; Person in charge of dilution uses 0.9% sodium chloride injection solution to formulate the drug substance into 4U/0.1mL composite solution, and the investigator injects it into the test subjects.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: botulinum toxin type A; Glabellar lines; wrinkles
Histologic Comparison of Healing After Tooth Extraction With Ridge Preservation Using Two Different Xenografts
Condition: Partial Edentulism
Study type: Interventional

Summary: 
      The purpose of this study is to compare the speed of bone healing of the two most commonly
      used xenografts on the market, Bio-Oss® and Salvin-Oss® using a tooth extraction ridge
      preservation model in participants scheduled for tooth extraction and subsequent receipt of a
      dental implant. Researchers hypothesize that there will be additional vital bone at 16-20
      weeks with Salvin-Oss®.
    

Detailed description: 
      This study focuses on xenografts to preserve alveolar bone after tooth extraction prior to
      placement of a dental implant. Extraction sites that are not grafted for ridge preservation
      may lose up to 50 percent of their ridge width the first year after extraction. Xenografts
      are one of several products on the market used to maintain ridge width after tooth
      extraction. This study aims to compare the two most commonly used, FDA-approved xenografts on
      the market, Bio-Oss® and Salvin-Oss, in the preservation of alveolar bone after extraction of
      non-molar teeth.

      The primary objective of this study is to histologically evaluate and compare the percentage
      of new bone formation in healing extraction sockets of non-molar teeth grafted with Bio-Oss®
      versus Salvin-Oss®. The secondary aim is to observe clinical changes in ridge height and
      ridge width after grafting with these two materials.
    

Intervention name(s): Bio-Oss®; Salvin-Oss®
Intervention type(s): Device; Device
Intervention description(s): Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction.; Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction.
Intervention MeSH terms: Salvin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomly assigned (1:1) to one of two treatment groups (Bio-Oss® or Salvin-Oss®) at the time of surgery through random selection of sealed envelopes.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: toothlessness
Study Evaluating the Efficacy and Safety of Yoni.Fit in Women With Stress Urinary Incontinence
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      Study to evaluate the safety and effectiveness of Yoni.Fit for the temporary management of
      stress urinary incontinence (SUI) in women.
    

Detailed description: 
      Randomized, comparator-controlled, single blinded, multicenter study to demonstrate the
      effectiveness, user acceptance, safety and tolerability of Yoni.Fit in the temporary
      management of stress urinary incontinence (SUI) in women.
    

Intervention name(s): Yōni.Fit Test Device; Yōni.Fit Comparator Device
Intervention type(s): Device; Device
Intervention description(s): The Yōni.Fit Test Device is a silicone pessary.; The Yōni.Fit Comparator Device is a silicone pessary with a different configuration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
VelaShape III Device in Comparison to Cryolipolysis for Circumferential Reduction
Condition: Abdominal Fat
Study type: Interventional

Summary: 
      The purpose of this study is to compare the clinical performance of the VelaShape III device
      with CoolSculpt for reduction of the waist, love handles and flanks.
    

Detailed description: 
      VelaShape is a non-invasive (not breaking the skin) device for Body Reshaping and Cellulite
      Treatment. VelaShape combines controlled infrared (IR) light and conducted bipolar
      radiofrequency (RF) energies with mechanical manipulation.

      The CoolSculpt System is a noninvasive device that reduces fat by freezing fat cells until
      they break apart.
    

Intervention name(s): VelaShape III; CoolSculpt
Intervention type(s): Device; Device
Intervention description(s): Subjects will receive one treatment to their entire waist / love-handle/ flanks area in a split-waist fashion, so that one side is treated with one device and the other side is treated with the other device. The treatment session will include: one side (right or left) treated with the VelaShape III device and the other side (left or right, respectively) with the CoolSculpt device. The subject will be randomized to one of 2 treatment groups, one will receive treatment to the left side with the VelaShape II and the right side will receive treatment with the CoolSculpt. The other group will receive treatment to right side with the VelaShape II and the left side will receive treatment with the CoolSculpt.; Noninvasive Cryolipolysis
Other intervention name(s): Vela; Zeltiq
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Syneron; Velashape; ELOS; Zeltiq; Cryolipolysis
The Effects of Facilitated Percutaeous Coronary Intervention in Acute Myocardial Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study to investigate whether the administration of high-dose tirofiban
      before primary PCI could reduce myocardial infarct size, using analysis of contrast-enhanced
      magnetic resonance imaging.
    


Intervention name(s): tirofiban
Intervention type(s): Drug
Intervention description(s): tirofiban (25 μg/kg bolus and 0.15 μg/kg/min maintenance infusion for 24 hours)
Intervention MeSH terms: Tirofiban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Angioplasty, Transluminal, Percutaneous Coronary; tirofiban; Magnetic Resonance Imaging; Myocardial Infarction