bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Dietary Fatty Acids on Cardiovascular Disease Risk Indicators and Inflammation
Condition: Dyslipidemia
MeSH terms: Cardiovascular Diseases; Dyslipidemias; Inflammation
Study type: Interventional

Summary: 
      The purpose of this study is to to determine the effect of habituation to diets with
      different types of dietary fat (stearic, palmitic and oleic) on selected Cardiovascular
      Disease (CVD) risk indicators with an emphasis on inflammation.
    

Detailed description: 
      Vegetable oils high in the specific fatty acids of interest - stearic (found in cocoa butter,
      meats), palmitic (found in meats, dairy and some plant oils) and stearic acid's metabolic
      product, oleic (found in olive and corn oil) - will be used to displace each other in a
      standardized diet and fed to mildly hypercholesterolemic postmenopausal women using a
      randomized-controlled crossover design. A critical issue remains unresolved - the relative
      comparability among . The findings from this research study will enable us to understand the
      mechanism and potential health effect of different types of fats. Each of the diet phases
      will be 5 weeks in length with a 2-4 week break between phases. All food and drink will be
      provided to study volunteers. Blood pressure and body weight will be monitored once per week
      and adjustments made, if necessary, to maintain a stable weight. During the 5th week of each
      diet phase, volunteers will come to the center on 3 consecutive days to provide fasting blood
      samples and a non-fasting blood sample.
    

Intervention name(s): diet
Intervention type(s): Other
Intervention description(s): Participants are fed diets enriched in oleic acid, palmitic acid or stearic acid.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: fatty acid
Xanthohumol and Prevention of DNA Damage
Condition: Oxidative Stress
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to learn if and in what amount a compound from hops,
      called xanthohumol (ZAN-tho-HUE-mol), prevents damage to DNA and oxidative stress. The human
      body is constantly exposed to oxidative stress from environmental compounds (e.g. air
      pollution) which may cause damage to DNA. The human body can repair some DNA damage, but too
      much DNA damage is harmful and may lead to cancer. Research done at OSU and around the world
      has shown that xanthohumol can stop or slow processes that lead to cancer.
    

Detailed description: 
      The purpose of this research study is to learn if and in what amount a compound from hops,
      called xanthohumol (ZAN-tho-HUE-mol), prevents damage to DNA and oxidative stress. The human
      body is constantly exposed to oxidative stress from environmental compounds (e.g. air
      pollution) which may cause damage to DNA. The human body can repair some DNA damage, but too
      much DNA damage is harmful and may lead to cancer. Research done at OSU and around the world
      has shown that xanthohumol can stop or slow processes that lead to cancer.

      Participants will consume a non-alcoholic beverage containing xanthohumol with breakfast,
      lunch and dinner for 3 weeks. Then they will go through a washout period of 3 weeks. And then
      they will consume the same beverage without the xanthohumol compound (placebo) for another 3
      weeks. Participants will be randomly assigned into groups and will vary whether they will
      consume the xanthohumol product during the first or second 3-week period. Xanthohumol doses
      will be 0, 6, 12 or 24 mg/day.

      The study includes donation of blood and urine samples and one-month food frequency
      questionnaires.
    

Intervention name(s): 6 mg xanthohumol per day; 12 mg xanthohumol per day; 24 mg xanthohumol per day; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will consume non-alcoholic beverage with 2 mg xanthohumol at breakfast, lunch and dinner for 3 weeks.; Participants will consume a non-alcoholic beverage with 2 mg xanthohumol at breakfast and lunch and 8 mg at dinner for 3 weeks.; Participants will consume a non-alcoholic beverage with 8 mg xanthohumol at breakfast, lunch and dinner for 3 weeks.; Participants will consume a placebo non-alcoholic beverage (0 mg xanthohumol) at breakfast, lunch and dinner for 3 weeks.
Intervention MeSH terms: Xanthohumol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: oxidative stress; hops; xanthohumol; DNA damage; cancer
Effect of Massage Therapy in Cortisol Level
Condition: Asymptomatic State
MeSH terms: Asymptomatic Diseases
Study type: Interventional

Summary: 
      This study evaluates the effect of a single session of Massage Therapy in salivary cortisol
      level. All participants were assessed on three conditions: Massage session, rest in supine
      position listening music, and under normal working conditions. The hypothesis of the
      investigators is that the effect of the massage action in reduction of cortisol is superior
      to only rest.
    

Detailed description: 
      Several studies have postulated that one of the physiological markers of the effect of
      massage therapy is to reduce the level of cortisol, the "stress hormone". However it is not
      clear whether the effect is due to the manual action on the skin, or only by the relaxation
      induced rest. Therefore the variation of salivary cortisol in both conditions, and also in
      everyday working conditions was compared. Cortisol has a circadian cycle, with a maximum
      value upon awakening, which decreases during the morning; therefore a sample of saliva (in
      Salivette tube) it was collected in the three experimental conditions at the same hour time
      in the morning: 8:45(after intervention), and 9:30 and 10.30 (both, before).
    

Intervention name(s): Massage Therapy; Rest in supine
Intervention type(s): Other; Other
Intervention description(s): It's a Physical Therapy manual procedure, based in Swedish technique, and applied in a standirzed way for all participants (stroke, kneading, pressure).; It's only rest, in a clinic stretcher, with warm ambient temperature, and listening relaxing music with headphones.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Massage; Stress; salivary cortisol
Study to Evaluate the Safety, Pharmacokinetics and Target Engagement of BMS-986142 in Healthy Subjects
Condition: Healthy Adult
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, pharmacokinetics, and target engagement
      of BMS-986142 in healthy subjects.
    

Detailed description: 
      Allocation: Randomized Controlled Trial (SAD/MAD) Masking: Double-Blind (SAD/MAD)
    

Intervention name(s): BMS-986142; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Volunteers
A Trial of TT223 in Patients With Type 2 Diabetes Who Are Taking Metformin and/or Thiazolidinedione
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is designed to show the effect of treatment with TT223 or placebo on blood glucose
      control after 12 weeks of treatment with a 6 month follow-up. TT223 is administered by
      injection once daily to patients currently treated with Metformin and/or Thiazolidinedione.
    


Intervention name(s): TT223 with Metformin and/or TZD; Placebo with Metformin and/or TZD
Intervention type(s): Drug; Drug
Intervention description(s): Daily subcutaneous injection: 1 mg for 1 week; followed by 2 mg for 1 week; followed by 3 mg for 10 weeks; Daily subcutaneous injection: 1 mg for 1 week; followed by 2 mg for 1 week; followed by 3 mg for 10 weeks
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: TT223
Serum CD14 and CD88 Mointoring in ICU
Condition: Sepsis
MeSH terms: Sepsis
Study type: Observational

Summary: 
      The present study will be conducted to determine the dynamic changes of serum soluble CD14
      and the corresponding changes of serum CD88 and their correlation in critically ill sepsis
      and SIRS patients.
    

Detailed description: 
      A total of ninty four will be included in the study. Forty seven patients are critically ill
      with evidence of sepsis during ICU stay (sepsis group) and forty seven patients are
      critically ill without evidence of infectious organism (SIRS group). At admission, Patients
      data include clinical status; SOFA score; central venous pressure; laboratory analysis and
      arterial blood gas analysis are measured. Routine cultures will be obtained. The attending
      physician will evaluate the patients for sepsis, severe sepsis, or septic shock as long as
      their stay in ICU. A serum level of CD 14 and CD88 will be monitored.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A total of ninety-four patients will be included in the study. Forty seven patients are
        critically ill with evidence of sepsis during ICU stay (sepsis group) and forty seven
        patients are critically ill without evidence of infectious organism (SIRS group). At
        admission, Patients data include clinical status; SOFA score; central venous pressure;
        laboratory analysis and arterial blood gas analysis are measured. Routine cultures will be
        obtained. The attending physician will evaluate the patients for sepsis, severe sepsis, or
        septic shock as long as their stay in ICU. A serum level of CD 14 and CD88 will be
        monitored.
      
Keywords: soluble CD14 ,serum CD88,sepsis , SIRS.
A Randomized, Double-blind, Pharmacokinetics Study to Assess Safety, Tolerability of Levetiracetam 45 Minutes Intravenous Infusion During 4 Days of Bid Dosing in Chinese Healthy Volunteers
Condition: Human Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The part B of N01362 is to assess the pharmacokinetic profile of Levetiracetam 1500 mg
      intravenous (iv) infusion during repeated dosing in Chinese healthy volunteers.
    

Detailed description: 
      The study includes 2 parts, part A is to evaluate the bioequivalence of Levetiracetam (LEV)
      1500 mg intravenous (iv) infusion when compared to oral tablet, part B is to assess the
      pharmacokinetic profile of LEV infusion during repeated dosing in Chinese healthy volunteers.
    

Intervention name(s): Levetiracetam; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Levetiracetam 1.500 mg (500 mg/ 5 mL vials) administered as a 45 minutes intravenous infusion diluted in 100 mL 0.9 % saline solution every 12 hours from the morning of Day 3 (it is the first day in Part B) to the morning of Day 7 (it is the 5th day in Part B).; 15 mL 0.9 % saline solution added to 100 mL 0.9 % saline solution, administered as a 45 minutes intravenous infusion every 12 hours from the morning of Day 3 ( it is the 1st day in Part B) to the morning of Day 7 (it is the 5th day in Part B).
Other intervention name(s): Keppra
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Keppra Levetiracetam intravenous; Multiple dose; Safety; Pharmacokinetics; Chinese healthy volunteers
Randomized Clinical Trial of Posterior Retroperitoneoscopic Adrenalectomy Versus Lateral Laparoscopic Adrenalectomy
Condition: Adrenal Tumor; Pheochromocytoma; Conn's Syndrome; Cushing's Syndrome
MeSH terms: Pheochromocytoma; Adrenal Gland Neoplasms; Cushing Syndrome; Hyperaldosteronism; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Laparoscopic adrenalectomy has become the gold standard operation for non-malignant adrenal
      tumors replacing open adrenalectomy. The most popular lateral transperitoneal laparoscopic
      adrenalectomy (LTLA) approach has been recently challenged by an increasing popularity of the
      posterior retroperitoneoscopic adrenalectomy (PRA) approach which is believed by many
      surgeons as an easy to learn, reproducible and beneficial for patients. However, this belief
      is not evidence-based, so far. The aim of this study is to clarify if PRA is superior to the
      LTLA as minimally invasive approach to small and benign adrenal tumors.
    

Detailed description: 
      Laparoscopic adrenalectomy has replaced open adrenalectomy as the standard operation for
      non-malignant adrenal tumours. Thanks to the popularization of the posterior technique
      described by Walz and co-workers, the posterior retroperitoneal adrenalectomy (PRA) is being
      performed in increasing numbers worldwide. Advocates for the laparoscopic and
      retroperitoneoscopic approaches cite the advantages of each technique, but there is no
      published evidence that supports the superiority of one over the other. Most of the published
      literature is retrospective, with inadequate or no controls and with potential biases.

      The aim of this study is to test the hypothesis that PRA is superior to the lateral
      transperitoneal laparoscopic adrenalectomy (LTLA) as minimally invasive approach to small and
      benign adrenal tumors.

      For a sample size calculation an assumption was made that a 20% reduction in duration of
      surgery represents clinically relevant difference. To detect this, it was calculated that 24
      patients would be required in each treatment arm to give the study a power of 90 per cent.
      Anticipating a 25% loss to follow-up, 32 patients per arm were required in the study.
    

Intervention name(s): Posterior RA; Lateral transperitoneal LA
Intervention type(s): Procedure; Procedure
Intervention description(s): Posterior retroperitoneoscopic adrenalectomy; Lateral transperitoneal laparoscopic adrenalectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lateral transperitoneal laparoscopic adrenalectomy; Posterior retroperitoneoscopic adrenalectomy
Arnold Chiari Malformation: the Otological Assessment as an Objective Criteria for Surgical Treatment
Condition: Arnold-Chiari Malformation, Type 1
MeSH terms: Arnold-Chiari Malformation; Congenital Abnormalities
Study type: Interventional

Summary: 
      The aim of this study is to compare the value of multifrequency tympanometry between patients
      with surgical indication of treatment for a Chiari type I malformation and healthy
      volunteers.
    

Detailed description: 
      Prevalence of Chiari type I malformation in population is between 0.1% and 0.5%. Chiari type
      I malformation is responsive in perturbation of the cerebro spinal fluid flow at the
      cranio-cervical junction. Those perturbations caused headaches, and various otological
      symptoms (dizziness, tinnitus, vertigo, nystagmus, hypoacousis…). The surgical treatment
      consists in an occipital craniotomy to restore the cerebro spinal fluid flow at the
      cranio-cervical junction. Symptoms are due to increasing of the pressure in the cerebellar
      fossa. 81% of the patients with Chiari type 1 malformation suffer of sub clinical otological
      perturbations especially alteration of the vestibular test.

      In the literature, hearing performance could be normalized after posterior fossa
      decompression. Furthermore, the multifrequency tympanometry measurement and particularly the
      width of conductance tympanograms at 2 kHz shows that variations of the cerebro spinal fluid
      pressure have consequences on the pressure of the perilymph.

      Investigator's hypothesis is that tympanometry (conductance) could be an effective test to
      show the variation of the cerebro spinal fluid pressure.
    

Intervention name(s): Multifrequency tympanometry at Inclusion; Multifrequency tympanometry 6 month after surgery
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Multifrequency tympanometry measurement and particularly width of conductance tympanograms at 2 kHz will be performed for both group at inclusion; Multifrequency tympanometry measurement and particularly width of conductance tympanograms at 2 kHz will be performed 6 months after surgery for Chiari type I malformation patient
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Arnold-Chiari Malformation, Type 1; Multifrequency tympanometry; Inner ear pressure
The Effects of Perioperative Nutritional Optimization on Blood Markers
Condition: Intervertebral Disc Disorders With Radiculopathy, Lumbar Region
MeSH terms: Radiculopathy
Study type: Interventional

Summary: 
      The purpose of this study is to see if taking an oral nutrition supplement (Ensure Nutrition
      Shake) before and after lumbar spine surgery affects blood tests related the nutritional
      status of patients. Patients with poor nutritional statuses who undergo elective lumbar spine
      surgery are at increased risk for complications and longer hospitalizations.
    

Detailed description: 
      The study will examine whether a simple and cost-effective perioperative nutritional program
      will affect blood markers of nutritional status (albumin, pre-albumin, transferrin,
      electrolytes). All patients 55 years and older who are undergoing lumbar spine surgery at our
      institution by a single surgeon and meet all inclusion criteria will be added to this study.
      Patients will be randomized into one of two arms; the interventional group will be provide
      with daily Ensure protein drinks for two weeks pre-operatively and four weeks
      post-operatively, while the control group will be instructed to continue their current diet
      plans. Four weeks post-operatively, blood markers (serum albumin, pre-albumin, transferrin,
      electrolyes) will be obtained to assess objective differences in nutritional status.

      N/A
    

Intervention name(s): Ensure
Intervention type(s): Dietary Supplement
Intervention description(s): Ensure protein is a complete nutritional drink with 10g, 240 calories, and 27 vitamins and minerals. It is often used as a nutritional supplementation in many hospitals.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study to Determine the Effect of BMS-791325 on the ECG QTcF Interval in Healthy Subjects
Condition: Hepatitis C
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether BMS-791325 has an effect on the
      electrocardiogram (ECG) interval QT corrected for Fridericia's method (QTcF).
    

Detailed description: 
      Primary Purpose: Other: This Phase 1 study is a clinical pharmacology thorough QT study.
    

Intervention name(s): BMS-791325; Moxifloxacin; Placebo matching BMS-791325
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Avelox®
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Effectiveness of Kaltenborn End Range Joint Mobilization Technique and Post FacilitationStretch in Shoulder Impingement Syndrome
Condition: Shoulder Impingement Syndrome
MeSH terms: Shoulder Impingement Syndrome; Syndrome; Rotator Cuff Injuries
Study type: Interventional

Summary: 
      This study is a experimental one to observe the efficacy of joint mobilization and post
      facilitation techniques in shoulder impingement syndrome
    

Detailed description: 
      his study is a experimental one to observe the efficacy of Kalternborn end range joint
      mobilization and post facilitation techniques in shoulder impingement syndrome. Goniometer,
      shoulder disability index will be the tool used for evaluation
    

Intervention name(s): KAlternborn Joint Mobilization; Post stretch Facilitation Technique
Intervention type(s): Other; Other
Intervention description(s): This is a join mobilization technique to reduce the joint stiffness and help in improving joint range of motion; This is a PNF techniques used to relax the muscles and help in getting more free range of restricted joint
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups will be formed. one group will receive joint mobilization technique and other will get post facilitation stretch technique
Masking: Single (Participant)
Primary purpose: Treatment
Effect of Oral Supplementation With Curcumin (Turmeric) in Patients With Proteinuric Chronic Kidney Disease
Condition: Proteinuria
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Proteinuria
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if the oral supplementation with curcumin reduces
      proteinuria in patients with chronic kidney disease regardless the ethiology.
    

Detailed description: 
      Curcumin is a potent antioxidant found in extracts of the rhizome of the plant Curcuma longa
      L.

      Different studies have demonstrated that curcumin has potent biological activity and
      therefore is an effective therapeutic agent for the treatment of various ailments.

      This compound acts as a bifunctional antioxidant:

      ه is capable of reacting directly with highly reactive oxygen species. ه acts indirectly by
      its ability to induce the expression of various cytoprotective proteins through
      Keap1/Nrf2/ARE pathway.

      Although RAAS blockade is the cornerstone to prevent the progression of proteinuric
      nephropathy, a significant number of patients remained with proteinuria and progress to
      end-stage renal disease.

      Due to the low cost and few side effects of curcumin, this could become an adjuvant treatment
      of proteinuric nephropathy purposes attenuate the progression of chronic kidney disease.
    

Intervention name(s): Curcumin
Intervention type(s): Drug
Other intervention name(s): Turmeric
Intervention MeSH terms: Curcumin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Stimulation of Gastric Slow Waves With Acupuncture at St36 and Pe6 - a Randomized Single-blind Controlled Trial
Condition: Acupuncture
Study type: Interventional

Summary: 
      Aim of the study is to investigate specific effects of acupuncture points.
    


Intervention name(s): verum acupuncture; sham acupuncture
Intervention type(s): Procedure; Procedure
Intervention description(s): acupuncture at St36 and Pe6; superficial needling at sham points
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: acupuncture; Acupuncture points