bioihbjkbjnl/mcl2 huggingface dataset:
Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia
Condition: Gestational Trophoblastic Tumor
MeSH terms: Trophoblastic Neoplasms; Gestational Trophoblastic Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of dactinomycin in treating patients who
      have persistent or recurrent gestational trophoblastic neoplasia.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the efficacy of dactinomycin in patients with persistent or recurrent low-risk
           gestational trophoblastic neoplasia.

        -  Determine the toxicity of this drug in these patients.

      OUTLINE: This is a multicenter study.

      Patients receive dactinomycin IV over 15 minutes on day 1. Treatment repeats every 2 weeks in
      the absence of unacceptable toxicity. Patients who achieve normal beta-human chorionic
      gonadotropin (HCG) receive 2 additional courses after attaining normal beta-HCG.

      Patients are followed every 2 weeks for 2 months and then monthly for 10 months.

      PROJECTED ACCRUAL: A total of 15-35 patients will be accrued for this study within 18-42
      months.
    

Intervention name(s): dactinomycin
Intervention type(s): Biological
Intervention MeSH terms: Dactinomycin
Primary purpose: Treatment
Keywords: recurrent gestational trophoblastic tumor; nonmetastatic gestational trophoblastic tumor; low risk metastatic gestational trophoblastic tumor
The Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional

Summary: 
      This single centre, dual site, comparative design study will be used to investigate the
      efficacy of an experimental stannous fluoride containing dentifrice in relieving dentinal
      hypersensitivity (DH) after short term use
    


Intervention name(s): Stannous Fluoride dentifice; Sodium Monofluorophosphate dentifrice
Intervention type(s): Device; Other
Intervention description(s): Experimental dentifrice containing 0.454% w/w stannous fluoride (1100ppm); Dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride)
Intervention MeSH terms: Fluorides; Tin Fluorides; Fluorophosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
An Evaluation of JUST Court in Yuma County, AZ
Condition: Substance Abuse; Adolescent Behavior; Juvenile Delinquency Unspecified
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      Arizona has created a pilot program for juvenile probationers called Juveniles under
      Supervision and Treatment (JUST), which includes swift and certain, but modest responses, to
      technical violations of the terms of juvenile probation. JUST targets high- and medium-risk
      juvenile probationers and its stated objective is to reduce violations and overall
      incarceration of youth in the program. The JUST pilot is being implemented under the
      authority of the Arizona Governor's Office for Children, Youth and Families (GOCYF) and the
      Administrative Office of the Courts (AOC).
    

Detailed description: 
      Arizona's Juveniles Under Supervision and Treatment (JUST) Court is a pilot project initiated
      by the Arizona Governor's office. It is designed to test whether the principles of Swift,
      Certain, and Fair (SCF) Supervision-clear rules, close monitoring, and swift and certain, but
      modest, penalties for each violation can succeed when applied to juveniles under community
      supervision. The Arizona Administrative Office of the Courts piloted JUST in two counties:
      Yavapai and Yuma. The Yuma program was launched in March 2011. The goal of JUST is to (a)
      reduce the violation rate so as to reduce the number of petitions filed to revoke probation
      (the purpose is to reduce the use of juvenile detention), and (b) reduce recidivism overall.
      All juveniles in Yavapai are supervised under JUST (evaluation using an RCT is therefore
      unfeasible). JUST in Yuma is now being scaled up, which affords the opportunity for an RCT.
      The goal of the RCT is to compare the performance of youth supervised under JUST with those
      supervised under probation-as-usual.
    

Intervention name(s): JUST
Intervention type(s): Other
Intervention description(s): Swift, certain, and proportionate sanctions for violations of terms of community supervision.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Comparison of Autologous PRF, 1% Alendronate and 1.2% Atorvastatin Gel in Chronic Periodontitis Treatment
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The present study is designed as a single-centre, randomized, controlled clinical trial to
      evaluate and compare the clinical efficacy of autologous PRF, 1% alendronate (ALN) and 1.2%
      atorvastatin (ATV) gel placement with open flap debriedement in treatment of intrabony
      defects in patients with chronic periodontitis.
    

Detailed description: 
      Background: Platelet-rich fibrin (PRF) is a second-generation platelet concentrate which
      releases various growth factors that promote tissue regeneration. Alendronate and
      Atorvastatin are known to inhibit osteoclastic bone resorption and were proposed to have
      osteostimulative properties by causing osteoblast differentiation in vivo and in vitro as
      shown by an increase in matrix formation. The aim of the present study is to evaluate and
      compare the efficacy of autologous PRF, 1% alendronate and 1.2% atorvastatin gel placement
      with open flap debriedement in treatment of intrabony defects in patients with chronic
      periodontitis.

      Methods: 120 CP subjects with IBD ≥3 mm deep and probing depth (PD) ≥5 mm, following scaling
      and root planing (SRP), were categorized into four treatment groups: 1) OFD 2) OFD with PRF
      3) OFD with 1% ALN gel and 4) OFD with 1.2% ATV gel. Clinical parameters including site
      specific plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD) and
      relative attachment level (RAL) as well as percentage radiographic intrabony defect depth
      reduction (DDR) were recorded at baseline before surgery and 9 months post-operatively.
    

Intervention name(s): Open flap debridement (OFD); OFD with PRF; OFD with ALN; OFD with ATV
Intervention type(s): Procedure; Biological; Drug; Drug
Intervention description(s): Oral prophylaxis followed by Open flap debridement (OFD); Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into the bone defect; Oral prophylaxis followed by Open flap debridement (OFD) with 1% ALN gel placement into the bone defect; Oral prophylaxis followed by Open flap debridement (OFD) with 1.2% ATV gel placement into the bone defect
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Attitudes and Understanding of Plant Sterol Claims on Food Labels
Condition: General Population; Consumer Research
Study type: Observational

Summary: 
      Daily consumption of plant sterols have been demonstrated to lower blood cholesterol. The
      Canadian government has recently allowed plant sterols to be added to certain foods and has
      also approved a disease risk reduction claim to be allowed on products containing plant
      sterols. However, it is unknown how Canadian consumers respond to plant sterol claims.

      The objective of this study was to evaluate the attitudes and understanding of different
      types of plant sterol claims on food labels
    


Intervention name(s): Mock package questionnaire
Intervention type(s): Behavioral
Intervention description(s): Within a online questionnaire we exposed participants randomly to 4 mock margarine packages differing only by the claim it carried and asked participants to answer several questions on attitudes and understanding after each mock package.
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A subsection of the Canadian Consumer Monitor Panel - a national representative online
        consumer panel comprised of 30,000 Canadians
      
Keywords: attitudes and understanding of plant sterol claims; general Canadian population
Individual Differences in Diabetes Risk: Role of Slow WaveSleep
Condition: Sleep; Diabetes
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      This study will examine the relationship between the amount of slow wave sleep (deep sleep)
      and the ability of the body to bring the blood sugar level to a normal range after receiving
      glucose.
    


Intervention name(s): baseline study
Intervention type(s): Behavioral
Intervention description(s): normal bedtimes
Observational model: Cohort
Sampling method: Non-Probability Sample
Study population: 
        normal healthy men and women
      
Biospecimen description: 
      serum
    
Keywords: sleep; insulin; diabetes; determine association between sleep characteristics and diabetes risk
Safety and Immunogenicity Study of Inactivated Vaccine for Prevention of COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is a randomized, double-blinded, and placebo controlled phase 1&2 clinical trial
      of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research & Development Co.,
      Ltd. The purpose of this study is to evaluate the safety and immunogenicity of the
      experimental vaccine in healthy children and adolescents aged 3-17 years
    

Detailed description: 
      This study is a randomized, double-blinded, single-center, placebo-controlled phase 1&2
      clinical trial in children and adolescents aged 3-17 years. The experimental vaccine and
      placebo were both manufactured by Sinovac Research & Development Co., Ltd. A total of 552
      subjects will be enrolled, with 72 at phase 1, and 480 at phase 2. Subjects will be assigned
      to receive two doses of different dosage of experimental vaccine or placebo on the schedule
      of day 0,28. Subjects in Phase receive the second dose 10 months or 12 months after the
      second dose.
    

Intervention name(s): Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28; Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28; Two doses of placebo at the schedule of day 0,28
Intervention type(s): Biological; Biological; Other
Intervention description(s): The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research & Development Co., Ltd., with a antigen content of 300SU/0.5ml; The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research & Development Co., Ltd., with a antigen content of 600SU/0.5ml; The placebo contains no active ingredient and manufactured by Sinovac Research & Development Co., Ltd.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Lean Body Weight-adjusted Rocuronium Dose and Intubation Conditions
Condition: Body Weight Changes; Rocuronium; Intubation Conditions
MeSH terms: Body Weight; Disease; Body Weight Changes
Study type: Observational

Summary: 
      In this study, researchers wiil administer rocuronium, based on either the lean body weight
      or the total body weight in patients with body mass index (BMI) of 18.5 to 34.9 and compared
      the duration of action of the drug and its effects on tracheal intubation conditions and
      hemodynamic parameters..
    

Detailed description: 
      The whole body will be routinely monitored with electrocardiogram, oximetry oximetry, and
      non-invasive arterial monitoring. For anesthesia induction, intravenous (IV) fentanyl 50-100
      µg and propofol 2mg/kg will be ventilated 100% by lightning. After optimal general anesthesia
      was achieved, the ulnar nerve was adapted and monitored at the wrist with TOF-Watch® SX
      (Organon, Swords Co., Dublin, Ireland). LBW lower content of 0.6 mg/kg rocuronium will be
      administered. K subgrade similar a dose based on TBW will be administered. The time to
      duration of rocuronium TOF responses will be measured (T1 (seconds)). All consumers will be
      intubated with a Macintosh laryngoscope diameter with endotracheal sold with inner tubes of
      7.5 8.0 mm and 7 mm to 7.5 mm. A single air anesthetist will evaluate the intubation target
      according to the Han-Raulo intubation scoreboard. Anesthesia will be provided with
      sevoflurane and an additional dose of phenyl. Monitoring with TOF was continued until the
      initial fasciculation power (T2=min) of the adductor pollicis decreased to 25% and was
      approached to an additional rocuronium dose of 0.3mg/kg. All anesthetic agents for operation
      will be discontinued and extubated when the TOF value reaches 90%.
    

Intervention name(s): he patients who are administered rocuronium according to LBW were categorized as "LBW", and The group number for those administer according to TBW was categorized as "K".
Intervention type(s): Procedure
Intervention description(s): Patients will be divided equally and validly by the one who will be placed in opaque sealed envelopes on a self-paid basis. One group will be given 0.6 mg/kg rocuronium on an LBW basis (Curon ® 50 mg/5 mL [Mustafa Nevzat, Istanbul, Turkey]), and the other group will be given 0.6 mg/kg rocuronium on a TBW basis.
Other intervention name(s): Groups will be divided into 2 groups by their own luck. According to DDA, rocuronium will be evaluated as "DDA", and group numbers given according to TBW will be evaluated as "K".
Intervention MeSH terms: Rocuronium
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        18-65 years, with ASA (American Society of Anesthesiologists physical status) ≤ II
      
Keywords: the lean body weight, rocuronium, intubation conditions
Influence of Local Bone Status on Complications After Surgical Treatment of Proximal Humerus Fractures
Condition: Proximal Humeral Fractures; Poor Bone Quality; Treatment Complications
MeSH terms: Fractures, Bone; Humeral Fractures; Shoulder Fractures
Study type: Observational

Summary: 
      The purpose of this study is to evaluate if poor bone quality increases the risk of specific
      types of treatment complications in patients with proximal humerus fractures treated with
      open reduction and angle-stable plates (Proximal Humeral Internal Locking System - PHILOS).
    

Detailed description: 
      More than 70% of patients with a proximal humerus fracture are older than 60 years, up to
      three quarters are women and the incidence of low-energy fractures increases exponentially
      with age. The standard diagnostic method for classifying osteoporosis is the measurement of
      Bone Mineral Density at specific body sites - hip, vertebra or distal radius. Despite the
      fact that osteoporotic fractures are very frequent at the shoulder, no study investigated the
      correlation between local bone quality and fracture treatment at the proximal humerus.

      There is a concern among the clinicians that osteoporotic bone in proximal humerus fractures
      increases the risk of treatment complications. However, to our knowledge this has not yet
      been evaluated in clinical studies. One major reason for this lack of studies is the fact
      that no standardized method exists for the determination of bone density at the proximal
      humerus.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Orthopedic and trauma clinics
      
Keywords: Humerus fractures; Tomography, x-ray computed; Bone and bones; Orthopedic fixation devices; Surgery; Postoperative complications; Osteoporosis; Intraoperative complications; Bone density; Radiography, dual-energy scanned projection
Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study to explore the effect of oral ozanimod as an induction treatment for
      participants with moderately to severely active Crohn's Disease.
    


Intervention name(s): Ozanimod; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Ozanimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Crohn's Disease; Crohn Disease; Oral; Ozanimod; Moderately active; Severely active; RPC01; RPC01-3202
Evaluating the Efficacy of Vardenafil in Subjects With Erectile Dysfunction (ED) Administered 12, 18 or 24 Hours Prior to Intercourse
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection
      sufficient for satisfactory sexual performance. However, there remains no prospectively
      obtained data on the maximal time of effectiveness of vardenafil. The goal of the current
      study was to determine if vardenafil will significantly increase the percentage of successful
      intercourse attempts from 12 to 24 hours following dosing. A total of three time points 12,
      18, and 24 hours were assessed in this pilot study to better quantify the effect of
      vardenafil.
    


Intervention name(s): Levitra (Vardenafil, BAY38-9456); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10mg and 20mg to be taken 12, 18, 24 hours prior to sexual intercourse; Matching placebo
Intervention MeSH terms: Vardenafil Dihydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Erectile Dysfunction; Vardenafil
Clinical Significance of Antiphospholipid Antibodies in Healthy Subjects
Condition: Antiphospholipid Antibodies
MeSH terms: Arteritis
Study type: Interventional

Summary: 
      Antiphospholipid (APL) antibodies are a heterogeneous family of auto-antibodies,
      predominantly represented by anticardiolipin (ACL) antibodies and lupus anticoagulant (LA).
      Antiphospholipid syndrome (APS) is defined as the presence of APL associated with venous
      and/or arterial thrombosis or repeated foetal loss. APS may be either primary or secondary to
      an autoimmune disease, mainly systemic lupus erythematosus (SLE). However, other than in the
      context of APS, APL can also be observed in various clinical situations and in healthy
      subjects. Published studies have reported a variable prevalence of APL in healthy subjects,
      essentially ACL and/or LA, and their clinical significance currently remains unclear.

      Several studies have highlighted the link between APL and atherosclerosis. It therefore
      appears interesting to more specifically study the association between the presence of APL
      and the presence of cardiovascular risk factors in a population of healthy subjects.
      Atherosclerosis is currently considered to be a chronic inflammatory disease arising from a
      complex interaction between atherogenic plasma factors and cells of the arterial wall.
      Several inflammatory markers are now known to be associated with cardiovascular risk. Lipid
      peroxidation also plays a major role during the atherogenesis process. It will therefore also
      be important to correlate APL with markers of vascular inflammation and markers of oxidative
      stress.

      A prospective case-control study will therefore be conducted on 1,500 healthy blood donors.
      Subjects screened APL-positive will be compared to APL-negative subjects in terms of
      cardiovascular risk factors (cardiovascular risk per se, the presence of cardiovascular
      disease will not be studied). In the context of a blood donation, all subjects wishing to
      participate in this study will attend a medical interview and a clinical examination during
      which various data will be collected, mainly the presence of cardiovascular risk factors. A
      blood sample will also be taken to assay the various laboratory markers studied.

      This study should provide a better understanding of the role of APL in healthy subjects and
      more clearly specify their possible link with atherosclerosis in this population.
    


Intervention name(s): blood sample
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: healthy subjects; cardiovascular risk factors; markers of arterial inflammation; markers of oxidative stress