bioihbjkbjnl/mcl2 huggingface dataset:
GDFT Based on PPV Compared With Standard Fluid Therapy in Patients Undergoing Complex Spine Surgery: RCT
Condition: Spine Disease
MeSH terms: Spinal Diseases
Study type: Interventional

Summary: 
      The investigators will do the Goal directed fluid therapy by protocolized fluid management in
      the experimental group, using PPV to guide the fluid administration, compare with standard
      fluid management in patients undergoing complex spine surgery.
    


Intervention name(s): goal directed fluid therapy; Controlled
Intervention type(s): Procedure; Other
Intervention description(s): pulse pressure variation will be used to as a goal to guide fluid administration in this group; standard fluid treatment by an anesthesiologist
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Perioperative Analgesic Modalities for Breast Cancer Surgeries
Condition: Analgesia
Study type: Interventional

Summary: 
      The incidence of breast cancer is among women world wide, detection increased with
      introduction of mammography as a screening tool. surgical resection of breast cancer
      contributes to the generation of acute and chronic post mastectomy pain. This study aims at
      comparing the effect of erector spinae block versus serratus block versus intravenous
      morphine in patients undergoing modified radical mastectomy for breast cancer surgeries
      regarding pain control and possible side effects
    

Detailed description: 
      One of the most common types of cancer affecting women is breast cancer. Surgical resection
      is one of the main approaches applied for solid tumors. surgical approach for breast cancer
      involve the breast region. Various analgesic modalities are used for proper perioperative
      pain control. Morphine has always been considered as the gold standard analgesic, however
      opioids have multiple side effects. Several loco-regional techniques have been introduced for
      breast surgery pain management including serratus plane block (SPB) and erector spinae plane
      (ESP) block. In this study the investigators are comparing the effect of erector spinae block
      versus serratus block versus intravenous morphine in patients undergoing modified radical
      mastectomy for breast cancer surgeries regarding intraoperative and postoperative analgesia,
      time to first analgesic, any possible side effects
    

Intervention name(s): serratus plane block; erector spinae block; Morphine Sulfate
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): ultrasound guided block; ultrasound guided block; intravenous morphine sulfate 0.1 mg/kg
Other intervention name(s): SAPB; ESPB; opioid
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Sham Controlled Clinical Trial of Renal Denervation in Patients With Resistant Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The purpose of this study is to assess the efficacy of catheter-based renal denervation in
      reducing blood pressure in patients with resistant hypertension compared to a sham procedure.
      Patients will be randomized to RDN or sham control in a 2:1 ratio. All participants will be
      switched to a single pill triple combination treatment prior to the procedure.

      A total of 105 patients will be recruited into the study, 70 patients in the RDN arm and 35
      patients in the sham control arm.

      The duration of this study is 36 months.
    


Intervention name(s): Renal Denervation; Sham control
Intervention type(s): Device; Other
Intervention description(s): Deliberate disruption of the renal nerves via radio frequency energy delivery to renal arteries.; Arterial access only. No delivery of radio frequency energy to renal arteries.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Renal denervation; Blood pressure; Cardiovascular risk; Target organ damage; Sympathetic activity; Non-compliance
Microvascular Function Assessment in Healthy Subjects
Condition: Physiology of Microvascular Skin
Study type: Interventional

Summary: 
      Current stimulation induces microvascular dilation in human skin. The investigators aimed to
      study (1) whether the current vasodilation is amplified after two segmental current
      stimulation as compared to one stimulation; (2) whether this amplification relies on
      prostaglandin-sensitive mechanisms. A double-blind randomized placebo-controlled crossover
      trial is conducted in Angers, France.
    


Intervention name(s): acetylsalicilic acids (Aspirin); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): single oral dose of 1g.
Other intervention name(s): Aspegic 1000mg, sanofi aventis.
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Laser Doppler flowmetry, skin, microcirculation
Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate higher versus standard adalimumab dosing regimens for induction and
      maintenance therapy in subjects with moderately to severely active Crohn's Disease and
      evidence of mucosal ulceration.
    


Intervention name(s): Adalimumab; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Humira
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Crohn's Disease
Bioavailability Study of 10 Milligram (mg) and 5 mg Tablets Versus Conventional Tablets of Dolutegravir
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this cross-over study is to compare the relative bioavailability and
      pharmacokinetic parameters of both 10 mg conventional tablets and 5 mg dispersible tablets of
      dolutegravir (DTG) with that of 25 mg or 50 mg conventional DTG tablets. The study will be
      carried out in 2 parts. Part 1 of the study will be open-label, 2 period designs with a wash
      out period of at least 7 days between the dosing periods. Subjects will be randomized to
      receive either single dose of five 10 mg DTG tablets or one 50 mg DTG tablet in a crossover
      manner in the fasting state. Part 2 of the study will be a 3 period crossover design with a
      wash out period of at least 7 days between the dosing periods. Subjects will be randomized to
      receive either single dose of five 5 mg DTG tablets (administered as dispersed with water or
      directly to mouth) or one 25 mg DTG tablet in a crossover manner in the fasting state.
      Subjects will have a follow-up visit 7-10 days post last dose of study treatment.
      Approximately 14 healthy subjects will participate in Part 1 and approximately 24 healthy
      subjects will participate in Part 2 of the study. The total duration of Part 1 will be
      approximately 7 to 8 weeks and that of part 2 will be approximately 8 to 9 weeks.

      TIVICAY® is a trademark of the GlaxoSmithKline group of companies.
    


Intervention name(s): Conventional dolutegravir 10 mg tablet; Conventional dolutegravir 50 mg tablet; Dispersible dolutegravir 5 mg tablet; Conventional dolutegravir 25 mg tablet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single dose of five 10 mg DTG tablets will be administered directly to mouth with 240 mL of water in the morning to randomized subjects in fasting state present in Part 1. DTG will be a white, round shaped, biconvex tablet.; Single dose of one 50 mg tablet will be administered directly to mouth with 240 mL of water in the morning to randomized subjects in fasting state present in Part 1. DTG will be a white, round shaped, biconvex tablet.; Single dose of five 5 mg DTG tablets will be administered as dispersed in water or direct to mouth with 240 mL of water in the morning to randomized subjects in fasting state present in Part 2. DTG will be a white, round shaped, biconvex tablet.; Single dose of one 25 mg DTG tablet will be administered directly to mouth with 240 mL of water in the morning to randomized subjects in fasting state present in Part 2. DTG will be a white, round shaped, biconvex tablet.
Intervention MeSH terms: Dolutegravir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dispersible tablets; Bioavailability; Dolutegravir; Healthy; Conventional tablets
The Effect of Testosteron Replacement Treatment on the Fibroblast Growth Factor-23, Asymmetric Dimethylarginine and Vitamin D Levels in the Congenital Hypogonadotropic Hypogonadism
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is designed to answer the following questions:

      1) What is the effect of testosteron replacement treatment on the endothelial dysfunction.

      2/ What is the effect of testosteron replacement on the bone mineral metabolism.
    

Detailed description: 
      this is an interventional study which is examine the effect of testosteron replacement
      treatment on the endothelial dysfunction and bone mineral metabolism in hypogonadotropic
      hypogonadal patients.
    

Intervention name(s): Testosterone
Intervention type(s): Drug
Intervention description(s): Testosterone 250 mg injection per 3-4 weeks for 6 months
Other intervention name(s): sustanon 250 mg
Intervention MeSH terms: Testosterone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: endothelial dysfunction; bone mineral metabolism; testosteron replacement treatment
Efficacy and Safety Study of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines
Condition: Skin Aging
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety of botulinum toxin type A compared to
      placebo control for the treatment of moderate to severe crow's feet lines.
    


Intervention name(s): Botulinum Toxin Type A; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Botulinum Toxin Type A, Dose A; dose applied to the lateral canthal lines; Placebo, Dose B; dose applied to the lateral canthal lines
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Physical Activity Referrals to the Community
Condition: Overweight; Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to determine the impact of primary care referrals to community
      physical activity programs for overweight and obese youth aged 6-18 years on objectively
      measured physical activity and cardiorespiratory fitness, as well as other cardiovascular
      health indicators. We hypothesize that physical activity referrals will result in higher
      levels of physical activity and fitness.
    


Intervention name(s): Physical activity referral
Intervention type(s): Behavioral
Intervention description(s): Provision of a primary care referral to at least one community-based physical activity program that is a good match for the participant's needs and preferences and patient follow-up on enrollment.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Pediatric Obesity; Physical Activity; Physical Fitness; Primary Health Care; Referral and Consultation
Indicators Predicting Surgery in Acute Severe Ulcerative Colitis(ASUC)
Condition: Ulcerative Colitis Acute; Surgery
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Observational

Summary: 
      Acute severe ulcerative colitis [ASUC] patients have high risk of no response to medical
      treatments and might miss the best timing for surgery when waiting for the medical response.
      Thus, we investigated whether biomarkers which could early predict the surgery risk of
      patients with ASUC on admission.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All acute severe ulcerative colitis patients were admitted in hospital and prospectively
        followed during the study period.
      
Keywords: acute severe ulcerative colitis; predictive indicator; surgery
Predictors of Depression Treatment Response to Exercise
Condition: Depression; Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      50 subjects with Major Depressive Disorder who are not currently receiving treatment will be
      enrolled in a 12-week exercise program, supervised by a trained exercise interventionist.
    

Detailed description: 
      50 subjects with Major Depressive Disorder who are not currently receiving treatment will be
      enrolled in a 12-week exercise program, supervised by a trained exercise interventionist.
      Blood samples will be collected at baseline for analysis of inflammatory cytokines, as well
      as other potential biological predictors of treatment outcomes (i.e., BDNF). Assessments will
      gather data on potential clinical predictors of treatment outcomes (anxiety, stress, sleep).
      Assessments and sample collection will also occur at 3 time points during the treatment
      period (Weeks 4, 8, and 12) to identify mediators and correlates of treatment effects.
    

Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): Subjects will engage in supervised exercise sessions for 12 weeks. Each week will consist of at least three exercise sessions with a total duration of weekly exercise of approximately 150 minutes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dose Finding Study Of CP-870,893, An Immune System Stimulating Antibody, In Combination With Paclitaxel And Carboplatin For Patients With Metastatic Solid Tumors
Condition: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a dose-finding study; therefore, there is no hypothesis testing
    


Intervention name(s): Paclitaxel + Carboplatin + CP-870,893; Paclitaxel + Carboplatin + CP-870,893
Intervention type(s): Drug; Drug
Intervention description(s): Paclitaxel is administered intravenously on day 1 of a 21-day cycle at a dose of 175 mg/m^2. Carboplatin is administered intravenously on day 1 of a 21-day cycle at AUC 6. CP-870,893 is administered intravenously on DAY 3 of a 21-day cycle in escalating doses (0.1 mg/kg and 0.2 mg/kg); Paclitaxel is administered intravenously on day 1 of a 21-day cycle at a dose of 175 mg/m^2. Carboplatin is administered intravenously on day 1 of a 21-day cycle at AUC 6. CP-870,893 is administered intravenously on DAY 8 of a 21-day cycle in escalating doses (0.1 mg/kg and 0.2 mg/kg)
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Carboplatin; Antibodies, Monoclonal
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess the Effectiveness and Safety of Different Doses of ASP1707 Compared to Placebo for Endometriosis Associated Pelvic Pain
Condition: Endometriosis
MeSH terms: Endometriosis; Pelvic Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective for this study is to assess the efficacy and dose-response relationship of
      ASP1707 in reduction of endometriosis associated pelvic pain. The secondary objectives are to
      assess the safety, tolerability, Pharmacokinetics of ASP1707, dose response relationship of
      ASP1707 in reduction of E2 (Estradiol), 24-week efficacy of ASP1707 in reduction of
      endometriosis associated pain and 24-week safety and tolerability of ASP1707.
    


Intervention name(s): ASP1707; Placebo; Leuprorelin acetate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral; Oral; subcutaneous
Other intervention name(s): Prostap® SR
Intervention MeSH terms: Leuprolide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phase 2; Double-blind; Pelvic pain; ASP1707; Placebo-controlled; Endometriosis
Physiology of Vestibular Dysfunction and Clinical Implications
Condition: Dysfunction of Vestibular System; Accidental Falls; Frailty
MeSH terms: Frailty
Study type: Observational

Summary: 
      Vestibular dysfunction is a known contributor to imbalance and fall risk, and may be a
      precursor to the frailty phenotype seen in the elderly population. A recent study found that
      vestibular dysfunction is common in the US population, and that the prevalence of this
      impairment increases steeply with age. However, it is unknown whether the aging process has
      global effects on the vestibular end-organ or whether specific structures, e.g. the
      semicircular canals or the otoliths, are selectively impaired. Moreover, the clinical
      implications of specific deficits of the vestibular end-organ are unclear. As such, the aims
      of this proposed research are: 1) to evaluate whether the normative aging process is
      predominantly associated with dysfunction of the semicircular canals (as measured by caloric
      and angular vestibulo-ocular reflex testing) or of the otoliths (as measured by
      vestibular-evoked myogenic potential (VEMP) testing); 2) to determine if there are any
      characteristic clinical features associated with the subtypes of vestibular dysfunction; and
      3) to assess whether dysfunction of the semicircular canals or of the otoliths is associated
      with a higher risk of frailty and falls. The investigators plan to pursue these aims through
      a cross-sectional and prospective cohort study of a group of individuals age 70 and above.
      Vestibular physiologic tests will be administered to all study participants, and test results
      will be correlated with baseline clinical symptoms and frailty status as well as prospective
      one-year fall risk. A greater understanding of vestibular physiologic deficits and clinical
      implications in older individuals can inform the development of rational vestibular
      rehabilitation strategies that may more effectively mitigate the frailty phenotype and reduce
      fall risk.
    


Intervention name(s): No intervention, observational study
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        community-dwelling adults age >70
Biliary Atresia, Hepatic Buffer Response and Sevoflurane
Condition: Biliary Atresia
MeSH terms: Biliary Atresia
Study type: Observational

Summary: 
      To evaluate the effects of sevoflurane on hepatic blood flow (HBF) and hepatic arterial
      buffer response (HABR) in infants with obstructive jaundice by Doppler ultrasound.Twenty-five
      infants with biliary atresia (1-3 months-of-age) scheduled for a Kasai procedure were
      enrolled. portal vein blood flow (PBF), hepatic arterial blood flow (HABF) and hepatic blood
      flow (HBF) were measured by Doppler ultrasound before induction, and after inhalation of 2
      and 3% sevoflurane.
    

Detailed description: 
      Children suffering from hepatobiliary disease also have an hepatic arterial buffer response
      (HABR) with reduced portal vein blood flow (PBF) and compensatory increases in hepatic
      arterial blood flow (HABF) which can help maintain hepatic blood flow (HBF). For infants with
      obstructive hepatobiliary disease, reduced HBF may affect drug metabolism and increase the
      risk of respiratory depression during analgesia, which can be life-threatening.

      To evaluate the effects of sevoflurane on HBF and HABR in infants with obstructive jaundice
      by Doppler ultrasound.Twenty-five infants with biliary atresia (1-3 months-of-age) scheduled
      for a Kasai procedure were enrolled. PBF, HABF and HBF were measured by Doppler ultrasound
      before induction, and after inhalation of 2 and 3% sevoflurane.
    

Intervention name(s): Sevoflurane
Intervention type(s): Drug
Intervention description(s): general anesthesia with 2% followed by 3% sevoflurane
Other intervention name(s): general anesthesia
Intervention MeSH terms: Sevoflurane
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        infants with biliary atresia scheduled for a Kasai procedure