bioihbjkbjnl/mcl2 huggingface dataset:
A Study of the Excretion Balance of Radiocarbon and the Pharmacokinetics and Metabolic Profile of TRO19622 (Olesoxime)
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase I study is designed to determine the excretion balance of radiocarbon, as the sum
      of carbon-14 (14C)-labeled TRO19622 and its 14C-metabolites, and to investigate the
      pharmacokinetics and metabolic profile of TRO19622 (olesoxime) in healthy participants.
    


Intervention name(s): Olesoxime
Intervention type(s): Drug
Intervention description(s): Olesoxime will be given orally on Day 1 as a 600-mg liquid suspension within 30 minutes after starting a standardized high-fat breakfast.
Other intervention name(s): TRO19622
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Randomized Clinical Trial of Skin Closure With Staples Versus Suture
Condition: Wound Infection; Wound Complication
MeSH terms: Wound Infection; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      Women with gynecologic cancers are often obese and have other risk factors for post-operative
      wound separation. Data from obstetrics and orthopedic surgery literature have shown a
      decreased risk of wound separation and complications when the skin is closed with suture as
      compared to staples. Skin closure with either staples or suture is considered standard of
      care. Traditionally, most wounds have been closed with staples given their ease of use and
      quick application. In this randomized study the investigators plan to evaluate and compare
      the complication rate associated with both standard closures.
    

Detailed description: 
      The investigators propose a randomized controlled trial to evaluate for a difference in wound
      complication rate between closure with sutures that are placed just below the skin level to
      hold the skin together and metal staples in obese women (BMI>=30) undergoing gynecologic or
      gynecologic oncology via a midline skin incision for benign or cancer indications under the
      supervision of one of the full-time faculty members of the Division of Gynecologic Oncology
      at Washington University School of Medicine.
    

Intervention name(s): 4-0 monofilament suture; Stainless steel staples
Intervention type(s): Device; Device
Intervention description(s): Skin closure using 4-0 monofilament suture; Skin closure using stainless steel staples.
Other intervention name(s): 4-0 Monocryl suture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Wound infection; Wound separation; Skin staples; Subcuticular suture
EHR Embedded Comparative Effectiveness Studies--WWC
Condition: Obesity
Study type: Observational

Summary: 
      Randomize Everyone is a research project to develop new informatics systems and statistical
      methods for supporting randomization processes in EHR systems to do comparative effectiveness
      research. Two demonstration projects are being conducted in the Dartmouth Hitchcock Medical
      Center, designed to evaluate different weight loss interventions and common practices in the
      treatment of chronic low back pain.
    

Detailed description: 
      EHR Embedded Comparative Effectiveness Studies-WWC will be held in the Weight and Wellness
      Clinics at Dartmouth-Hitchcock Medical Center. This study consists of randomizing enrollees
      to either the dietitian/health coach appointment sequence or the health coach/dietitian
      appointment sequence.
    

Intervention name(s): Healthy Lifestyles Program; Obesity Medicine Program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Regular group visits with a health coach in addition to routine dietician and clinician visits, reviewing successes and challenges from the previous session as well as data collected through self-monitoring; A tailored approach to obesity care for patients including individual dietician and health coach visits as appropriate.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients in the Weight & Wellness Clinic who are eligible for either Healthy Living Program
        or Obesity Medicine Program
A Study to Evaluate the Effect of High Fat Meal on Cabotegravir
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Cabotegravir is being developed for the treatment of human immunodeficiency virus (HIV) 1
      infection. Specifically, it is being developed as a component of a 2-drug maintenance regimen
      (post-induction of viral suppression) that includes rilpivirine. Rilpivirine requires food
      for optimal absorption; therefore the recommended intake of cabotegravir in the planned Phase
      3 treatment studies is with food regardless of fat or calorie content, when administered
      along with rilpivirine. This is a single-center, randomized, open-label, two-way crossover
      study in healthy adult subjects to assess the effect of a high fat meal on the single dose
      pharmacokinetics of CAB 30 mg. Approximately, 24 subjects will be enrolled in the study and
      will be screened for 30 days. Twelve subjects with at least 10 hours of fasting will be
      randomized to receive a single dose of cabotegravir orally (Schedule 'A'). The remaining 12
      subjects will receive a single dose of cabotegravir orally along with high fat meal (Schedule
      'B'). After 15 days, the subjects earlier undergoing 'Schedule A' will be switched to
      'Schedule B' and those undergoing 'Schedule B' will undergo 'Schedule A'. All the subjects
      will be followed up to 30 days from the day of receiving first dose of cabotegravir to
      evaluate the effect of a high fat meal on the pharmacokinetics of cabotegravir.
    


Intervention name(s): Cabotegravir 30 mg
Intervention type(s): Drug
Intervention description(s): Cabotegravir (GSK1265744B ) is available as white to almost white, oval shaped, film coated tablet, of weight 515 mg. The tablet contains micronized cabotegravir, lactose monohydrate, microcrystalline cellulose, hypromellose, sodium starch glycolate, and magnesium stearate. Each tablet is equivalent to 30 mg cabotegravir and needs to be taken orally with 240 mL of water. Cabotegravir tablet will be administered to subjects either in fasting condition or following a high fat meal.
Intervention MeSH terms: Cabotegravir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fasted; healthy volunteers; cabotegravir; high fat; pharmacokinetics; randomized; Phase I; two way crossover
Efficacy of GONB in Patients of Migraine
Condition: Chronic Migraine; Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 4

Summary: 
      The study was carried to determine the analgesic efficacy of greater occipital nerve block in
      patients of migraine. It was a randomised controlled which took place from april 2022 -
      october 2022. Fifty patients suffering from migraine were included in the study. Patients in
      Group G were given greater occipital nerve block (GONB) with lignocaine and dexamethasone
      under ultrasound guidance while those in Group S were given saline 0.9% as placebo. Pain
      score using Numeric Rating Scale and number of headache days was assessed at four,eight and
      twelve weeks after the procedure as a primary outcome. Total headache days were recorded as a
      secondary outcome.
    


Intervention name(s): Greater Occipital Nerve Block with dexamethasone and lidocaine; Greater Occipital Nerve Block with 0.9% saline
Intervention type(s): Drug; Drug
Intervention description(s): Ultrasound guided Greater occipital nerve block on the side of headache; Ultrasound guided Greater occipital nerve block on the side of headache
Other intervention name(s): GONB with dexamethasone and lidocaine; GONB with 0.9% saline
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Lidocaine; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Prednisone for Heart Failure Patients With Hyperuricemia
Condition: Heart Failure, Hyperuricemia
MeSH terms: Heart Failure; Hyperuricemia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Hyperuricemia is a very common finding in patients with heart failure. It is usually related
      to diuretic use and deteriorated renal function. The recently evidence showed that prednisone
      and allopurinol may have similar effect on uric acid (UA) lowering in symptomatic heart
      failure patients with hyperuricemia, but prednisone may be superior over allopurinol in renal
      function improvement. Thus the investigators design this randomized head to head study to
      test their hypothesis that prednisone is superior over allopurinol in renal function
      improvement despite their similar effect on UA lowering in heart failure patients with
      hyperuricemia.
    

Detailed description: 
      Hyperuricemia in heart failure (HF) is linked to renal impairment, hemodynamic compromise,
      and inflammation. Hyperuricemic HF patients are characterized by worsening of renal function
      and fragile volume state, both of which restrict the use of non-steroidal anti-inflammatory
      drugs (NSAIDs) when treating concurrent inflammatory diseases. Recent small studies suggest
      that steroidal anti-inflammatory drug, prednisone, may have renal protective, UA lowering,
      and potentiating diuretic effects in hyperuricemic HF patients. However, general acceptance
      of prednisone as a treatment option for anti-inflammation therapy in patients with
      hyperuricemic HF requires more safety data. We therefore designed a randomized study to
      compare the safety and renal protective effects of short-term use of prednisone with
      allopurinol, a widely used xanthine oxidase inhibitor with a well-established safety profile
      in HF, in hyperuricemic HF patients.
    

Intervention name(s): Prednisone; Allopurinol
Intervention type(s): Drug; Drug
Intervention MeSH terms: Prednisone; Allopurinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Resistance Exercise and Knee Osteoarthritis Pain, Functional Impairment and Cartilage Turnover
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The purpose of this study is to determine if a 4 month resistance exercise program can reduce
      knee osteoarthritis pain functional impairment and cartilage turnover.
    


Intervention name(s): normal activities and clinical care; Concentric Focused Resistance Exercise; Eccentric Focused Resistance Exercise
Intervention type(s): Other; Other; Other
Intervention description(s): Subjects will continue to participate in their normal activities and clinical care during the four month study. Telephone contact will be made weekly to encourage adherence to the knee management guidelines; Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.; Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: knee; osteoarthritis; pain; function; impairment
Comparison of Postoperative QoR-15 Scores Between Propofol and Remimazolam
Condition: Patients Undergoing Spine Surgery
Study type: Interventional

Summary: 
      Remimazolam is a ultra-short-acting benzodiazepine, and unlike conventional benzodiazepine
      drugs, it is rapidly metabolized in plasma and not accumulates in the body for long periods
      of infusion or even with high dose administration. In addition, it has no injection pain and
      infusion syndrome compared with propofol. In particular, there is no study to investigate
      overall postoperative functional recovery via QoR-15 in patients receiving TIVA using
      remimazolam. Therefore, rhe purpose of the study is to compare poetoperative quality of
      recovery (QoR)-15 scores according to the use of anesthetics for total intravenous anesthesia
      in the cervical spine surgery with intraoperative neurophysiological monitoring.
    


Intervention name(s): Propfol group; Remimazolam group
Intervention type(s): Drug; Drug
Intervention description(s): Propfol group will be started and maintained total intravenous anesthesia with propofol and remifentanil under target controlled infusion (TCI) model.; Remimazolam group will be started total intravenous anesthesia with remiamazolam at 6 mg/kg/h for induction, and maintained at 0.5-1.5 mg/kg/h and remifentanil under TCI model.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Effectiveness of Auricular Acupressure on the Methadone Patient
Condition: Conditions:Effectiveness of Auricular Acupressure on the Methadone Patient
Study type: Interventional

Summary: 
      This study aims to investigate the effect of auricular point sticking on constipation in
      patients with methadone
    

Detailed description: 
      This study is a randomized controlled trial, taking 72 methadone constipation patients from a
      hospital in the north as objects, and divided them into an auricular point group and a
      control group. The experimental group was given auricular point sticking, while the control
      group only used sticking cloth. The two groups were measured for constipation, TCM
      constitution, anxiety, depression and quality of life before the intervention and 2 weeks, 4
      weeks, and 6 weeks after the start.
    

Intervention name(s): Auricular pressure
Intervention type(s): Other
Intervention description(s): The seeds of blancia blanc were fixed on the acupoints with patches. The intervention measure in the experimental group was auricular point sticking. The two groups received four measurements before the intervention and 2 weeks, 4 weeks, and 6 weeks after the start; while the control group received no Auricular pressure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
An Immunogenicity and Safety Study of Sabin Inactivated Poliovirus Vaccine (Vero Cell) in 2-month-old Infants
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this phase III study is to evaluate the immunogenicity and safety of Sabin
      Inactivated Poliovirus Vaccine (Vero cell) in 2-month-old infants.
    

Detailed description: 
      The study is a randomized, double-blind, controlled randomized, double-blind, controlled
      clinical trial clinical trial. The purpose of this study is to evaluate the immunogenicity
      and safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) manufactured by Sinovac
      Vaccine Technology Co., Ltd in 2-month-old infants. The control vaccine is a commercialized
      Inactivated Poliovirus Vaccine manufactured by Sanofi Pasteur company. 1200 healthy infants
      between 60-90 days will be randomly assigned into experimental group or control group in the
      ratio 1:1.
    

Intervention name(s): Investigational sIPV; Control IPV
Intervention type(s): Biological; Biological
Intervention description(s): Three intramuscular injections of the investigational vaccine (0.5 ml) on Day 0, Day 30 and Day 60 respectively; Single intramuscular injection of the investigational vaccine (0.5 ml) at 18 months; Intervention: investigational sIPV; Three intramuscular injections of the control vaccine (0.5 ml) on Day 0, Day 30 and Day 60 respectively; Single intramuscular injection of the control vaccine (0.5 ml) at 18 months; Intervention:control IPV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Sabin strain; Inactivated poliovirus vaccine; poliomyelitis; safety; immunogenicity; infant
Safety & Effectiveness on Vascular Structure and Function of ACZ885 in Atherosclerosis and Either T2DM or IGT Patients
Condition: Diabetes Mellitus, Type 2; Atherosclerosis; Prediabetic State
MeSH terms: Atherosclerosis; Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the effect of ACZ885 on vascular function in patients with
      documented atherosclerotic disease and T2DM or IGT.
    


Intervention name(s): ACZ885; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ACZ885 150 mg was administered subcutaneously once a month for 12 months.; Matching placebo to ACZ885 was administered subcutaneously once a month for 12 months.
Other intervention name(s): Canakinumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atherosclerosis,; Type 2 Diabetes Mellitus, T2DM,; Cardiovascular Diseases, ACZ885, impaired glucose tolerance, IGT, Canakinumab
Study of Efficacy of Phenytoin in Therapy of Children With Bronchial Asthma
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to determine whether antiepileptic drug phenytoin is effective
      in the treatment of chronic asthma in children.
    

Detailed description: 
      Effective therapy of asthma still remains quite serious problem. According GINA definition,
      asthma is an inflammatory disorder. Consequently, modern pharmacotherapy of asthma provides
      wide use of anti-inflammatory drugs. But asthma also is a paroxysmal disorder: many
      specialists and even some guidelines underline paroxysmal clinical picture of asthma. Besides
      this, according to some authors, neurogenic inflammation may play important role in asthma
      mechanism. It is known that some other neurogenic inflammatory paroxysmal disorders exist,
      and they are migraine and trigeminal neuralgia. Antiepileptic drug phenytoin is very
      effective in therapy of trigeminal neuralgia - more than in 70-80% of cases. Other
      antiepileptic drugs, salts of valproic acid, are effective in the treatment of migraine. If
      bronchial asthma also is paroxysmal inflammatory disease, like migraine and trigeminal
      neuralgia, it is possible that some antiepileptic drugs also are very effective in asthma
      therapy.

      We perform a double-blind, placebo-controlled 3-month trial for evaluation of phenytoin
      efficacy in therapy of bronchial asthma in children. Phenytoin is a well-known, comparatively
      safe and effective antiepileptic drug with low cost. According our previous data, phenytoin
      is effective drug for asthma therapy in adults.

      Comparison: children will receive investigational drug in addition to their usual routine
      antiasthmatic treatment, compared to patients received placebo in addition to their usual
      routine antiasthmatic treatment.
    

Intervention name(s): Phenytoin
Intervention type(s): Drug
Intervention MeSH terms: Phenytoin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Bronchial asthma; Phenytoin; Antiepileptic drugs; Efficacy
Broccoli, Peas and PIN
Condition: Prostatic Intraepithelial Neoplasia
MeSH terms: Neoplasms; Carcinoma in Situ; Prostatic Intraepithelial Neoplasia
Study type: Interventional

Summary: 
      This is a parallel human intervention trial to determine to what extent a dietary
      intervention of broccoli or peas can change the expression (switching on or off) of genes in
      prostate tissue in men diagnosed with high-grade Prostate Intraepithelial Neoplasia (PIN).
    

Detailed description: 
      Cancer is one of the main causes of death among humans in the world. Prostate cancer affects
      20,000 men in the UK alone each year. Diet is known to be a major factor that influences risk
      of cancer. Therefore, changes to the diet may alter cancer risk. Cruciferous vegetables,
      particularly broccoli, provide the diet with a substantial source of plant chemicals called
      glucosinolates. Previous research has indicated that glucosinolates break down to form
      isothiocyanates (ITCs) that can be absorbed in the body. Further research has indicated that
      ITCs may protect the body against the development of prostate cancer. However, the mechanisms
      behind this effect are not fully understood.

      ITCs are thought to be powerful anti cancer agents as they can modulate the expression
      (switching on or off) of specific genes involved in the removal of toxic substances such as
      carcinogens from the body. In this study we wish to evaluate the effect of consumption of a
      conventionally bred cultivar of broccoli containing high levels of ITCs on gene expression in
      prostate tissue to gain a better understanding of its mechanism of action. Several studies
      suggest a further protection against cancer amongst individuals who have a deletion of
      certain genes.

      This pilot study comprises a 12-month intervention of either 400g ITC-enriched broccoli per
      week of 400g garden peas in men at high risk of developing prostate cancer. Changes in gene
      expression of prostate biopsy tissue will be compared before and after 6 and 12 months of
      intervention in both dietary groups.
    

Intervention name(s): Broccoli; Peas
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 400g ITC-enriched broccoli per week for 12 months; 400g frozen garden peas per week for 12 months
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Gene expression; Prostate; Broccoli; Cancer; Men diagnosed with high-grade Prostatic Intraepithelia Neoplasia
Safety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency
Condition: Diabetes Mellitus, Type 2
MeSH terms: Renal Insufficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This clinical trial is designed to provide additional information on the safety and
      tolerability of vildagliptin (50 mg once daily (qd)) when used in patients with type 2
      diabetes mellitus (T2DM) and moderate or severe renal insufficiency.
    


Intervention name(s): Vildagliptin; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Galvus
Intervention MeSH terms: Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2 diabetes, vildagliptin