bioihbjkbjnl/mcl2 huggingface dataset:
TEAS Enhanced Recovery After Laparoscopic Colon Surgery
Condition: Postoperative Recovery
Study type: Interventional

Summary: 
      The purpose of this study is to observe the effects of transcutaneous electrical acupoint
      stimulation(TEAS) on postoperative recovery after laparoscopic colon surgery.
    

Detailed description: 
      Patients were randomly assigned to two groups, receiving TEAS andno stimulation respectively.
      Interventions were given 30min before anesthesia and 1, 2 , 3 day after surgery, lasted 30min
      each time . The acupoints of TEAS group are bilateral ST36/SP6 combined with PC6/LI4, and the
      control group only attach electrodes without electric current. The frequency of TEAS is set
      to 2/10 Hz. After surgery, the time of meeting discharge criteria, first flatus and
      defecation were recorded. Score of PONV, life quality, sleep quality and VAS of pain were
      evaluated 24, 48 and 72h after surgery. The postoperative complications, re-exploration, cost
      of hospitalization and adverse events were also recorded.
    

Intervention name(s): TEAS; false stimulation
Intervention type(s): Other; Other
Intervention description(s): Electric stimulation was given through electrode attached to specific acupoints; Electrodes were attached to specific acupoints without electric current
Other intervention name(s): Acupuncture; Electric stimulation; sham stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postoperative recovery; colon surgery
Temozolomide Phase II Clinical Study in Patients With Newly Diagnosed Glioblastoma Multiforme (Study P04661)(COMPLETED)
Condition: Glioblastoma
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety of combination therapy of radiotherapy
      and temozolomide ("concomitant radiotherapy phase"), and then temozolomide monotherapy
      ("monotherapy phase"), in patients with newly diagnosed glioblastoma multiforme. Progression
      free survival and response rate will also be calculated.
    


Intervention name(s): Radiotherapy; Temozolomide
Intervention type(s): Radiation; Drug
Intervention description(s): Radiotherapy will be administered in combination with temozolomide during the concomitant radiotherapy phase. Radiotherapy will consist of a conventionally fractioned regimen, delivering a total dose of 60 Gy in 6 weeks, in a once daily schedule of 2 Gy per fraction, for a total of 30 fractions. Radiation will be provided by a linear accelerator of x ray energy of 4 MV or higher.; During the concomitant radiotherapy phase (6 weeks), temozolomide will be administered in combination with radiotherapy, once daily at 75 mg/m2/day. Then, during the monotherapy phase, subjects will receive 6 cycles of temozolomide alone. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m2/day, and may be increased to 200 mg/m2/day for Cycle 2 and subsequent cycles depending on nonhematologic toxicity observed and neutrophil and platelet count values. Capsules containing 5 mg, 20 mg, or 100 mg of temozolomide will be combined to achieve each subject's calculated dose.
Other intervention name(s): Irradiation, radiation therapy; Temodal, Temodar, SCH 052365
Intervention MeSH terms: Temozolomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
HL-085 in NRAS-mutated Advanced Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This was an open-label, single-arm, multi-center phase II clinical study, aimed at
      investigating the efficacy and safety of HL-085 capsule in the treatment of advanced melanoma
      patients with NRAS mutation.
    

Detailed description: 
      This was an open-label, single-arm, multi-center phase II clinical study, aimed at
      investigating the efficacy and safety of HL-085 capsule in the treatment of advanced melanoma
      patients with NRAS mutation. The primary objective was to evaluate the objective response
      rate (ORR) of oral HL-085 capsule in patients with advanced melanoma harboring NRAS mutation.
      The secondary objectives were to evaluate the progression-free survival (PFS), disease
      control rate (DCR), duration of remission (DOR), 1-year survival rate, overall survival (OS)
      and safety.
    

Intervention name(s): HL-085
Intervention type(s): Drug
Intervention description(s): HL-085 capsule administered orally twice daily (BID) in a 21-day treatment cycle
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HL-085; MEK inhibitor; NRAS mutation; advanced melanoma
Efficacy and Safety Study of KIACTA in Preventing Renal Function Decline in AA Amyloidosis
Condition: Amyloidosis
MeSH terms: Amyloidosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to assess the efficacy and safety of treatment with
      Kiacta in adult patients with AA Amyloidosis.
    


Intervention name(s): KIACTA (eprodisate disodium); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Orally 1 to 3 capsules (Kiacta 400 mg) twice daily and adjusted as per the Creatine Clearance (CrCl) level increases or decreases.; Orally 1 to 3 capsules (placebo) twice daily and adjusted as per the Creatine Clearance (CrCl) level increases or decreases:
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Kiacta for AA amyloidosis
Effects of Portion Size of Multiple Items at a Meal on Food Intake of Adults
Condition: Feeding Behaviors
Study type: Interventional

Summary: 
      This study tests the effect of serving larger portions of all foods in a meal on the outcome
      of food and energy intake. Using a crossover design, participants are served the meal once a
      week for four weeks and the portion sizes are varied at each meal. Some of the foods served
      at the meal are low in calorie density (calories per gram) and some are higher in calorie
      density. The aim is to determine whether intake in response to larger portions differs
      depending on characteristics of the subjects or of the foods.
    


Intervention name(s): Food portion size
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study to Evaluate the Safety, Tolerability, PK and PD of PB2452 in Healthy Younger, Older and Elderly Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2A, randomized, double-blind, placebo-controlled, single dose, sequential
      group study to evaluate the safety, tolerability, PK, and PD of PB2452 vs matching placebo
      with ticagrelor (with or without acetylsalicylic acid (ASA)) pretreatment when various dose
      levels and administration regimens are administered to healthy younger (ages 18 to 50), older
      (ages 50 to 64 years) and elderly (ages 65 to 80 years) male and female subjects.

      Up to 5 dose levels and/or administration regimens will be evaluated in up to 5 cohorts. Each
      cohort will include approximately 8 to 12 subjects randomized in a 3:1 ratio
      (PB2452:placebo).
    

Detailed description: 
      The study will consist of a Screening period, a Check-in day and Pretreatment Period, an
      on-site Randomization/Treatment day, 3 days on-site for treatment and safety monitoring, a
      Follow-up Visit (Day 7), and a Final Follow-up visit (Day 28). Seven days prior to
      Randomization, subjects in Cohorts 1 and 2 will be administered ASA 81 mg orally once daily
      (QD) until the final dose on the morning of Day 1 before receiving study drug. A ticagrelor
      180 mg oral dose will be administered on the morning of Day -2 followed by either 90 mg or
      180 mg every 12 hours until the 5th dose has been administered on the morning of Day 1.

      On Day 1, subjects who meet all the inclusion criteria and none of the exclusion criteria
      will be randomized in a ratio 3:1 (PB2452:placebo), to receive an IV dose of PB2452 or
      placebo 2 hours following the 5th ticagrelor dose. Subjects may be discharged from the
      clinical site between Days 3 and 7 inclusive and will return for a Follow-up visit on Day 7,
      if already discharged, and on Day 28 (±2 days).
    

Intervention name(s): PB2452 Infusion; Placebo - Sodium Chloride; Ticagrelor Oral Tablet - Pre-Treatment; Ticagrelor Oral Tablet - Pre-Treatment and Post-Treatment; Ticagrelor Oral Tablet - Pre-Treatment; PB2452 Infusion; Placebo - Sodium Chloride
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 30 minute - 24 hour infusion; 30 minute - 24 hour infusion; Ticagrelor 180 mg + 90 mg BID for 5 doses prior to PB2452 or Placebo; Ticagrelor 180 mg + 90 mg BID for 5 doses prior to PB2452 or Placebo and Ticagerlor 180 mg 24 hours following PB2452 or Placebo; Ticagrelor 180 mg BID for 5 doses prior to PB2452 or Placebo; 30 minute - 16 hour infusion; Placebo - Sodium Chloride
Intervention MeSH terms: Ticagrelor
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Spironolactone and Vitamin E in Patients With Nonalcoholic Fatty Liver Disease
Condition: Fatty Liver; Steatohepatitis
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary aim of the study is the effect of spironolactone and vitamin E versus vitamin E
      on serum levels of adipokines 52 weeks post-treatment.
    

Detailed description: 
      Unlike other chronic liver diseases (e.g., hepatitis C), there are no effective treatment
      strategy for NAFLD. Currently, the management of NAFLD includes modification of underlying
      risk factors, detection of patients that have progressed to cirrhosis, management of
      cirrhosis-related morbidity and transplantation in patients with end-stage liver disease.
      Diet, exercise, bariatric surgery and pharmacologic treatment, including weight loss agents,
      insulin sensitizers, lipid-lowering agents, ursodeoxycholic acid and vitamin E have been
      investigated with some promising results.

      The renin-angiotensin-aldosterone system (RAAS) has been implicated in the pathogenesis of
      insulin resistance (IR) and nonalcoholic fatty liver disease (NAFLD). Recently, low-dose
      (25-50 mg/day) aldosterone antagonists in patients with heart failure diminish mortality,
      possibly by reducing cardiac and vascular fibrosis. Moreover, the beneficial effect of
      spironolactone in a mouse model with diet-induced diabetes and NAFLD has been reported.
      However, to our knowledge, the role of spironolactone in NAFLD patients has not been
      investigated yet.

      The primary aim of the study is the effect of spironolactone and vitamin E versus vitamin E
      on serum levels of adipokines 52 weeks post-treatment.
    

Intervention name(s): Spironolactone/Vitamin E
Intervention type(s): Drug
Intervention description(s): Spironolactone, tablets, 25 mg daily plus Vitamin E, capsules, 400 mg daily, for 52 weeks
Other intervention name(s): Aldactone tab 25; Eviol caps 100
Intervention MeSH terms: Vitamin E; Spironolactone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nonalcoholic fatty liver disease; nonalcoholic steatohepatitis; adipokines; spironolactone; vitamin E; adiponectin; visfatin; leptin; resistin; TNF-alpha; IL-6; IL-1
Evaluation of Infants Fed an Extensively Hydrolyzed Hypo Allergenic Infant Formula
Condition: Gastrointestinal Tolerance
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the growth and compliance of an intended use
      population of infants receiving an extensively hydrolyzed infant formula.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be enrolled from outpatient clinics and physician offices.
Dextroamphetamine-Cocaine Behavioral Intervention - 5
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine dextroamphetamine-cocaine behavioral intervention in
      cocaine dependent patients.
    


Intervention name(s): Dextroamphetamine; D-amphetamine; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 15 mg of d-amphetamine for first 8 weeks of study and 30 mg for the second 8 weeks; 15 mg of d-amphetamine for first 8 weeks of study and 30 mg for the second 8 weeks; placebo
Intervention MeSH terms: Amphetamine; Dextroamphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cocaine dependence
Correlation Between Cyriax's Functional Examination and Ultrasound Examination in Patients With Shoulder Pain
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Observational

Summary: 
      Shoulder problems cause substantial disability in daily living, work, leisure activity, and
      exercise. The presence of shoulder problem such as rotator cuff pathology reported was highly
      predictive of impaired health-related quality of life.

      Many tests were used for physical examination of the shoulder. The reliability and validity
      of the tests have been studied before. However, a systemic review concluded that there was
      conflicting evidence in reliability of each or combined tests. Functional examination of the
      shoulder by Cyriax is composed of a series of tests to evaluate a shoulder problem. It
      includes three arm elevation, three tests for glenohumeral joints, and six resisted tests.

      As far as the investigators know, correlation of Cyriax functional examination with the
      ultrasonographic findings has never been reported before. Therefore, the aim of this study is
      to compare the clinical diagnosis by Cyriax's functional examination with ultrasound findings
      in patients with shoulder pain.
    

Detailed description: 
      There are two groups with fifty patients in each group. First group is patients who have
      unilateral or bilateral shoulder pain from the outpatient clinic of Department of Physical
      Medicine and Rehabilitation in Shin Kong Wu Ho-Su Memorial Hospital. The other group is
      control group who has no shoulder problems. Both groups will receive Cyriax's functional
      examination of the shoulder after history taking, and will be examined by shoulder ultrasound
      in one week.
    

Intervention name(s): Cyriax's functional examination; Ultrasound examination
Intervention type(s): Other; Device
Intervention description(s): included active range of motion, passive range of motion, resisted test and accessory test for shoulder pain evaluation; to evaluate rotator cuff, acromio-clavicular joint, and subdeltoid-subacromial bursa
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with or without shoulder pain
      
Keywords: Cyriax's functional examination; Ultrasound; Correlation; Resisted test
Tezepelumab Home Use Study
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, randomized, open-label, parallel-group study designed to assess
      healthcare provider and subject/caregiver reported functionality and performance of a
      single-use accessorized pre-filled syringe (APFS) or autoinjector (AI) with a fixed 210 mg
      dose of tezepelumab administered subcutaneously in the clinic and in an at-home setting.
    

Detailed description: 
      The study will consist of a screening/run-in period of up to 2 weeks and a treatment period
      of 24 weeks, followed by a post-treatment follow-up period of 12 weeks. During the treatment
      period, one dose of 210 mg tezepelumab will be administered via a single-use APFS or AI
      subcutaneously (SC) every 4 weeks (Q4W) starting at Visit 2 (Week 0) until Visit 7 (Week 20).
      Subjects will be administered tezepelumab at the site during Visits 2 (Week 0), 3 (Week 4), 4
      (Week 8) and 7 (Week 20). At-home administration of tezepelumab will occur during Visit 5
      (Week 12) and Visit 6 (Week 16). Each device will be assessed separately using descriptive
      presentations.
    

Intervention name(s): Tezepelumab (APFS); Tezepelumab (AI)
Intervention type(s): Biological; Biological
Intervention description(s): Tezepelumab subcutaneous injection, administered by Accessorized pre-filled syringe (APFS).; Tezepelumab subcutaneous injection, administered by Autoinjector (AI) device.
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized 1:1 to either an accessorized pre-filled syringe or an autoinjector. Both will be administered 210 mg tezepelumab subcutaneously.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma, Severe Uncontrolled Asthma
Choline Dehydrogenase and Sperm Function: Effects of Betaine
Condition: Men Carrying 2 Minor Alleles for Choline Dehydrogenase rs12676; Male Infertility
MeSH terms: Infertility; Infertility, Male
Study type: Interventional
Phase: Phase 1

Summary: 
      The ability of sperm to swim is important for normal fertility. Men with a genetic variation
      in the gene coding for Choline Dehydrogenase (CHDH) have decreased energy production by
      sperm, and their sperm do not swim normally. The metabolic product of this gene is a nutrient
      called betaine (found normally in the diet as a part of many foods such as spinach, beets and
      grain products). This study tests whether treatment with betaine is safe and whether it can
      normalize energy production in sperm of these men and restore normal swimming ability.
    

Detailed description: 
      Unidentified genetic aberrations such as single nucleotide polymorphisms (SNPs) may be the
      underlying cause of many cases of idiopathic infertility in men. Choline dehydrogenase
      (encoded by CHDH) converts choline to betaine in the mitochondria. 5-9% of men have 2 alleles
      for a functional SNP in CHDH (rs12676), and they have low sperm adenosine triphosphate (ATP)
      concentrations with impaired sperm motility (asthenospermia) that should decrease fertility.
      Male mice in which CHDH is deleted also have very low sperm ATP, asthenospermia and are
      infertile. Supplementation of these mice with dietary betaine increases sperm motility and
      ATP concentrations.

      This purpose of this study is to conduct a phase I study of betaine treatment in men with 2
      minor alleles for CHDH rs12676 to determine whether betaine supplementation is safe and to
      obtain preliminary data on the effects of betaine on sperm mitochondrial ATP concentrations
      and sperm motility in these men.
    

Intervention name(s): Betaine supplement
Intervention type(s): Drug
Other intervention name(s): BetaPower (Dupont Nutrition)
Intervention MeSH terms: Betaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Sperm motility
Aronia Berry Consumption on Vascular Function
Condition: Healthy Young Men
Study type: Interventional

Summary: 
      There is an increasing interest in the effects of various food derived polyphenols on
      vascular function. Arguably the most well-established vascular benefits are attributed to
      flavanols from cocoa beans and this has been supported by a successful health claim through
      the European Food Safely Authority in 2012. Berry fruits are another rich source of
      polyphenols that have vasoactive properties, and there is a growing body of research
      exploring these effects in various berries (blueberries, cranberries, strawberries) and other
      fruit products with similar polyphenol composition. A key (poly)phenol in berries and other
      fruits believed to provide much of the benefit is anthocyanins. When given as an isolated
      extract, 320 mg anthocyanins have been found to improve blood vessel function both acutely
      and in response to chronic consumption over 12 weeks.

      Aronia berries are a native North American berry with high naturally occurring anthocyanins
      among other polyphenols. Based on their polyphenol composition, there is growing interest in
      the potential for Aronia berries to elicit health promoting cardio-metabolic effects.
      Specifically, Aronia berry extracts, which provide a concentrated source of polyphenols, may
      improve blood vessel function.

      Thus, the primary focus of this project is to evaluate the effects of Aronia berry extracts
      of differing polyphenol dose on vascular endothelial function.
    


Intervention name(s): Placebo; Aronia full spectrum; Aronia extract
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Identical formulation as the treatment consisting of colored maltodextrin using artificial colors.; Powdered whole fruit obtained from aronia berries (Aronia melanocarpa); Powdered extract obtained from aronia berries (Aronia melanocarpa)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Vascular function; Endothelial function; (Poly)phenols
Hyperthermic Yoga for Depressive Symptoms
Condition: Depression; Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Study is a randomized controlled trial to assess the feasibility, acceptability, efficacy,
      and mechanisms of action of hyperthermic yoga versus a waitlist control for 80 medically
      healthy adults with mild to moderate depressive symptoms. The primary aim is to test the
      acceptability and feasibility of hyperthermic yoga as a treatment for depression. The
      secondary aim is to examine the effect size/efficacy of hyperthermic yoga for depressive
      symptoms. The tertiary aim is to explore physiological and psychological mechanisms of
      action.
    


Intervention name(s): hyperthermic yoga
Intervention type(s): Behavioral
Intervention description(s): heated yoga, 90-minutes
Other intervention name(s): Bikram Yoga
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment