bioihbjkbjnl/mcl2 huggingface dataset:
Preemptive Analgesia With OxyContin Versus Placebo Before Surgery for Long Bone Fractures
Condition: Fractures
MeSH terms: Fractures, Bone
Study type: Interventional
Phase: Phase 4

Summary: 
      We would like to check whether pre-operative administration of an oral controlled-release
      opioid formulation (Oxycodone hydrochloride (OxyContin)) could result in a clear effect of
      preemptive analgesia.
    

Detailed description: 
      Preemptive analgesia is based on the concept of treating pain before inflicting the painful
      stimulus. One suggested mechanism is that transmission of pain signals is altered when the
      patient is treated before infliction of noxious stimulation. That prevents changes from
      happening in the nervous system, making transformation from acute to chronic pain ("central
      sensitization") less likely, and thus reducing post operative pain.

      Clinically, good post operative pain control has been shown to be an effective method for
      hastening patient convalescence and discharge. It makes part of a general approach aiming to
      accelerate surgical recovery through earlier enteric feeding and ambulation

      OxyContin tablets deliver Oxycodone at a controlled release manner, over 12 hours. After oral
      administration oral bioavailability is 60-87%.

      A biphasic absorption pattern is observed, describing the initial (0.6 hours) and prolonged
      (6.9 hours) release of Oxycodone from the OxyContin tablets. Clinical analgesia is observed
      within 1 hour of administration.

      We believe that this mode of oral drug release is more appropriate for the perioperative pain
      treatment of patients undergoing short to medium term operations: with timely administration,
      the first absorbed part of the drug reaches the plasma before infliction of the noxious
      stimuli, possibly counteracting primary sensitization, and the second part absorbed, acts on
      post operative ongoing pain, possibly counteracting more advanced stages of neuronal
      plasticity.

      Study Hypothesis:

      Our hypothesis is that post operative pain will be lowered by pre-operative administration of
      OxyContin. When comparing the two groups we will look for differences in observed parameters,
      especially VAS numbers, time to first analgesic request, post operative analgesic
      requirements, time to first oral intake and length of hospitalization, to confirm or deny our
      hypothesis.
    

Intervention name(s): Oxycodone hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: long bone fracture; open fractures; closed fractures; trauma
Assessment of Left and Right Ventricular Function in Patients With Ebstein Anomaly With Different Echocardiographic Methods
Condition: Ebstein Anomaly
MeSH terms: Ebstein Anomaly; Congenital Abnormalities
Study type: Observational

Summary: 
      Ebstein anomaly is a rare congenital heart disease. It encompasses abnormalities of the
      tricuspid valve, the right atrium and the right ventricle (RV).

      Currently, cardiac magnetic resonance imaging (MRI) is considered the method of choice for
      the assessment of RV volume and function. To evaluate the right heart function VentriPoint
      method was designed to assess the RV in a fraction of the time, resulting in better efficacy
      and lower costs. VentriPoint is approved for Tetralogy of Fallot patients as well as patients
      with systemic RV in d-transposition of the great arteries. This method uses 2 dimensional
      standard ultrasound views linked to a VentriPoint Medical Systems unit. After acquisition,
      the physician identifies anatomical landmarks with dots on a number of the 2D ultrasound
      views through the heart. With a sensor (magnetic tracking system: GPS) on the ultrasound
      probe we know where the 2D plane is in 3D space. In this way the precise anatomical landmark
      is located in 3D space.

      The aim of the present study is to assess the feasibility, reliability and accuracy of the
      echocardiographic knowledge-based 3D reconstruction method to measure RV volume and function
      in patients with Ebstein anomaly. The accuracy of the method will be assessed by comparison
      with measurements obtained by cardiac MRI.

      In addition to the right ventricle the investigators want to assess the left ventricular
      function in patients with Ebstein anomaly in this study. By using speckle tracking
      echocardiography the investigators would like to investigate on the left ventricular
      contractility, rotation and synchrony of the left ventricle together with the RV. Not seldom
      the left ventricle is neglected in a patient with Ebstein anomaly by impressive findings of
      the right ventricle. Changes in the myocardial left ventricular structure (non compaction)
      are also described and may have negative impact on the function.

      The investigators want to analyze 25-30 patients with Ebstein anomaly including children
      starting at 11 years of age.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Ebstein anomaly patients of the Zurich Area followed by primary care center
Curcuminoids and Contrast-induced Acute Kidney Injury
Condition: Acute Kidney Injury; Contrast Media Toxicity; Curcuminoid; Chronic Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Acute Kidney Injury; Wounds and Injuries
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The objective of this study was to evaluate the role of curcuminoids in the prevention of
      CI-AKI in CKD patients.The result of the study was prophylactic administration with
      curcuminoids in addition to standard treatment reduce the incidence of CI-AKI CKD patients
      undergoing elective CAG.
    

Detailed description: 
      This study was a single-center, prospective, double-blinded, randomized placebo-controlled
      trial in CKD patients undergoing elective coronary angiography (CAG) at Vajira hospital from
      October 2018 to March 2019. Patients were stratified according to baseline estimate
      glomerular filtration rate (eGFR) and diabetes status. They were randomized to Curcuminoids
      1,500 milligrams per day starting 3 days before and 2 days after coronary procedure or
      placebo. The primary outcome was the development of CI-AKI, defined as serum creatinine
      rising ≥ 0.3 mg/dL within 48 hours after coronary angiography. The secondary outcomes were
      overall AKI incidences within 7 days after CAG, changes in eGFR, IL-6 hs-CRP, and other
      adverse events.

      A total of 60 patients were enrolled( 30 in curcuminoids group, and 30 in the control group).
      Overall AKI developed in 5 patients in control group and none in curcuminoids group (16.67%
      versus 0%, p-value 0.052). The results showed that curcuminoids could preserve changes in
      eGFR compared to the placebo group (-1.5 vs 2.5 mL/min/1.73m2, p-value <0.001 within 48 hours
      and -4 versus 1 mL/min/1.73m2, p-value 0.002 within 7 days). The high-sensitive C-reactive
      protein (hs-CRP) and IL-6 levels were not different between patients receiving curcuminoids
      and placebo. In curcuminoids group, 3 patients developed mild nausea and diarrhea that
      improved with supportive care. No serious adverse events were found in both groups.
    

Intervention name(s): Curcuminoid; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients were stratified according to baseline eGFR and diabetes status with 1:1 assignment into curcuminoids and placebo group. Curcuminoids (250 mg capsules) were purchased from the Government Pharmaceutical Organization of Thailand (Anti-ox® registration number 1A 1/60(H)), which contained curcumin: demethoxycurcumin: bis-demothoxycurcumin at the ratio of 1:0.5:0.2.; Identical capsules were used for the placebo from the same manufacturer.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective, double-blinded, randomized placebo-controlled study
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: contrast-induced acute kidney injury; Curcuminoids; coronary angiography
Short-term Structured Exercise Training Program Plus Diet Intervention in Patients With Polycystic Ovary Syndrome (PCOS)
Condition: Polycystic Ovary Syndrome; Anovulation
MeSH terms: Polycystic Ovary Syndrome; Anovulation; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Clomiphene citrate (CC) is the first-line therapy for infertile women with polycystic ovary
      syndrome (PCOS). Unfortunately, at least 20% of PCOS results are not responsive to CC.
      Structured exercise training (SET) and diet has been successfully employed to restore ovarian
      function and to improve reproductive outcomes in obese and overweight women with PCOS. The
      current study was aimed to test the hypothesis that a short-term SET program plus diet
      intervention can improve the ovarian response to CC in CC-resistant PCOS patients.
    

Detailed description: 
      Ninety-six PCOS patients considered CC-resistant because not responsive to 150 mg daily of CC
      were randomized in three arms (group A, B, and C). Group A underwent SET program plus
      hypocaloric diet for two months, group B had one month of observation followed by one-cycle
      of CC therapy, and group C underwent SET program plus hypocaloric diet for two months and
      received one-cycle of CC for one cycle. CC was always given at the maximal dose previously
      used. Clinical, hormonal and metabolic data were assessed at baseline and after intervention.
      Ovulation was monitored by ultrasound and confirmed by plasma progesterone assay.
    

Intervention name(s): SET-diet plus clomiphene; Clomiphene citrate; Structured exercise program plus hypocaloric diet
Intervention type(s): Other; Drug; Behavioral
Intervention description(s): Two months of structured exercise program plus hypocaloric diet followed by 150 mg daily of clomiphene citrate; Clomiphene citrate at 150 mg daily for one cycle; SET plus diet
Other intervention name(s): Lifestyle modification; CC; CC; Lifestyle modifications
Intervention MeSH terms: Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Clomiphene; Diet; Exercise; Infertility; PCOS; Physical activity; Treatment
The Safety, Tolerability, Pharmacokinetics(PK) of SR419 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the safety, tolerability, PK of SR419 in healthy volunteers.
    

Detailed description: 
      This is a Phase I study to evaluate the safety, tolerability, PK of SR419 in healthy
      volunteers. The study will include 3 parts.

      Part A is a double-blind, randomized, placebo-controlled, single-dose escalation study of
      SR419 in healthy young subjects.

      Part B is a double-blind, randomized, placebo-controlled, repeated-dose escalation study of
      SR419 in healthy young subjects.

      Part C is a double-blind, randomized, placebo-controlled, repeated dose study of SR419 in
      healthy elderly subjects.
    

Intervention name(s): SR419; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ascending single and multiple doses of SR419 orally; Ascending single and multiple doses of placebo orally
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
An Effectiveness and Safety Study of CONCERTA® (Methylphenidate Hydrochloride) in the Treatment of Adolescents With Attention Deficit Hyperactivity Disorder
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of CONCERTA®
      (methylphenidate hydrochloride, a central nervous system (CNS) stimulant) versus placebo for
      the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents..
    

Detailed description: 
      The objective of this study is to evaluate the safety and effectiveness of CONCERTA®
      (methylphenidate hydrochloride) in the treatment of adolescents with Attention Deficit
      Hyperactivity Disorder (ADHD). This is a multicenter, randomized, double-blind,
      placebo-controlled study with adolescents ages 13-18 diagnosed with ADHD. The study consists
      of four phases. The Screening Phase establishes the diagnosis of ADHD and provides a one-week
      washout period without any ADHD medication. The Open-Label Titration Phase initiates the
      treatment of patients with one CONCERTA® 18 mg daily. Thereafter, the dose is increased
      approximately every 7 days in 18 mg increments (to a maximum of 72 mg daily), until an
      individualized dose is identified, based on the clinical judgment of the investigator. During
      the Double-Blind Phase, subjects are randomized to receive either their individualized
      CONCERTA® dose or a placebo, for a period of 2 weeks. Subjects who successfully complete the
      Double-Blind Phase are eligible to receive CONCERTA® for an 8-week, Open-Label, Follow-up
      Phase. The primary efficacy measurement is the total score of the ADHD Rating Scale,
      evaluated by the investigator at the end of the Double-Blind Phase. Safety assessments
      include monitoring adverse events, electrocardiograms (ECG), blood pressure, pulse, height
      and weight throughout the course of the study. The study hypothesis is that CONCERTA® is more
      effective than placebo in the treatment of Attention Deficit Hyperactivity Disorder in
      adolescents, and is well tolerated.

      Titration Phase: CONCERTA® 18 mg taken orally, once daily, and increased approximately every
      7 days in 18 mg increments up to a maximum daily dose of 72 mg. Double-Blind Phase:
      Individualized dose of CONCERTA® or placebo for 2 weeks. Open-Label Phase: Individualized
      dose of CONCERTA® for 8 weeks.
    

Intervention name(s): methylphenidate hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder; ADHD; Concerta
Pain Sensitivity in Acute Inflammatory Pain
Condition: Healthy Volunteers Are Studied
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      Pain is a complex experience influenced by gender and genetics, and, by psychosocial and
      sensory experiences. Pain sensitivity is thus highly variable between individuals.

      In the present study we evaluate individuals´ pain perception in response to a number of
      different pain stimuli in 100 healthy volunteers (50 females and 50 males).

      The data will allow us to assess pain sensitivity, to predict pain responses and to
      investigate gender related differences in pain perception.

      A second aim is to evaluate the robustness of the different pain-tests since the tests are
      repeated with an interval of 2-4 weeks.
    

Detailed description: 
      Pain perception is affected by physiological, psychological, existential and demographic
      factors.

      In the present study psychophysiological, psychological, genetic and demographic components
      in pain perception are evaluated in healthy volunteers (n = 100).

      Psychophysical assessments following induction of a first degree burn injury (47.0 C, 420 s,
      12.5 sq.cm, lower leg) include:

        -  pain during induction of burn injury

        -  thermal thresholds

        -  tactile thresholds

        -  electrical thresholds

        -  areas of secondary hyperalgesia

        -  pressure algometric assessments

        -  assessment of Diffuse Noxious Inhibitory Control (DNIC) efficiency

        -  assessment of (DNIC) using cold pressor test

      Psychological assessments include:

        -  HADS (Hospital Anxiety and Depression Scale)

        -  PCS (Pain Catastrophizing Scale)

        -  vulnerability score

      Genetics include:

      - A118G SNP

      Demographics include:

        -  gender

        -  height

        -  weight
    

Intervention name(s): first degree cutaneous burn injury
Intervention type(s): Procedure
Intervention description(s): application of thermode (5 x 2.5 cm) to lower leg temperature 47.0 C, 420 s
Other intervention name(s): Modular Sensory Analyzer Thermotest (Somedic, Hörby, Sweden)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: burn injury; cold pressor test; gender; pain; pain sensitivity; pain prediction; psychometrics; quantitative sensory testing
Community Based Obesity Prevention Among Black Women
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This study will evaluate the efficacy of a behavioral intervention, designed to prevent
      weight gain among overweight and low obese (25-34.9 kg/m2) Black women (aged 25-44), compared
      to usual care.
    

Detailed description: 
      Obesity prevention among Black women is a major public health priority; presently, nearly 54%
      of the adult Black female population is obese. To date, most intervention attention has been
      focused on weight reduction among the overweight and obese. However, both conditions are
      notoriously recalcitrant to treatment, particularly among Blacks. We posit that obesity
      prevention might represent a particularly effective intervention strategy for overweight
      Black women. Most studies have shown that Black women have a greater social acceptance of
      overweight, less body weight dissatisfaction, and higher ideal body weights, compared to
      Whites. Furthermore, numerous studies have shown that obesity is less lethal and causes fewer
      co-morbidities among Black vs. White women, suggesting that maintaining overweight may be an
      appropriate public health goal for Black women. We posit that an intervention approach that
      emphasizes maintaining overweight, while preventing the transition to obesity will resonate
      among the target population. Very few obesity prevention RCTs appear in the published
      literature and, to our knowledge, none have been conducted solely among Black women.

      We propose to randomize overweight, Black women (n=184) to either usual care (UC) or an
      obesity prevention (OP) intervention condition. The OP condition is comprised of several
      intervention components that will be delivered over 12 months; each participant will receive
      a tailored action plan, tailored print materials, monthly coaching calls, and weekly
      self-monitoring via an interactive voice response system. Assessments will be taken at
      baseline, 6, 12, and 18 months post baseline.
    

Intervention name(s): Obesity Prevention
Intervention type(s): Behavioral
Intervention description(s): This arm includes an action plan, tailored print materials, telephone support calls, interactive self-monitoring, and a 12-month YMCA membership for the participant.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Obesity; Women's health; Minority health; Obesity prevention
Evaluation of a Commercial Program on Weight Loss and Health Outcomes
Condition: Obesity; Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To examine weight loss and acceptability of a modified WW program. This study is designed to
      detect differences in weight loss at the end of 24 weeks of intervention.
    

Detailed description: 
      This trial is an examination of a modified WW food program. The intention is to document the
      acceptability and efficacy of the dietary plan over 24 weeks. Subjects will participate in a
      program similar to WW Freestyle and have access to study-specific weekly workshops and a
      suite of study-specific digital tools for tracking eating, activity, and weight. Within a WW
      program, participants are provided instructions on calculating points for the foods and
      beverages they eat and drink. This study will examine the impact of the modified WW food
      program on weight and fitness levels of adults with overweight and obesity.
    

Intervention name(s): Modified WW Food program
Intervention type(s): Behavioral
Intervention description(s): Participants will receive a structured, holistic, behavioral weight management program that encourages development of healthy habits to help individuals eat healthier, move more, and shift to a more helpful mindset.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: This single-armed trial will have one condition: the modified WW Food program.
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate Clinical Effect, Pharmacokinetics , Safety, and Tolerability of Umeclidinium in Palmar Hyperhidrosis Subjects
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Umeclidinium (UMEC) is a potent pan-active long-acting muscarinic antagonist (LAMA). It is
      anticipated that topical administration of UMEC will block stimulation of muscarinic
      receptors, thereby reducing the overproduction of sweat in subjects who suffer from
      hyperhidrosis. This study will assess the clinical effect, pharmacokinetics, safety and
      tolerability of topically applied UMEC following once daily topical administration, for 28
      days, to the palms, in subjects with primary palmar hyperhidrosis. The study will also
      investigate if topically applied UMEC, at the highest possible concentration, will decrease
      palmar hyperhidrosis with a systemic anticholinergic adverse event profile similar to or
      below that observed with inhaled administration. This is a double blind (Sponsor unblind),
      repeat dose, randomized, parallel group, placebo controlled study. Study will enrol up to 55
      subjects.
    


Intervention name(s): Umeclidinium; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Umeclidinium (GSK573719) 1.85% will be supplied as a clear, colourless solution, free from visible particulates, for topical application. Each subject total daily dose will be calculated as per study reference manual (SRM) using subject's hand area. A single dose of study treatment will be based on the size of the subject's hand in order to provide coverage of approximately 2µL/ cm^2. If certain pre-specified criteria for safety and tolerability are met, consideration will be given to decreasing the dose by decreasing the concentration of the topical formulation to 1.15% for the remaining subjects.; The vehicle will be supplied as a clear, colorless solution, free from visible particulates, for topical application.This formulation will be similar to the umeclidinium formulation except that it will be devoid of the umeclidinium parent. A single dose of study treatment will be based on the size of the subject's hand in order to provide coverage of approximately 2µL/ cm^2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Topical; Palmar Hyperhidrosis; Umeclidinium