bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Progesterone on Stress Reactivity and Cannabis Use
Condition: Cannabis Use
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a research study to find out if a hormone called progesterone affects marijuana
      users' stress response and marijuana use. Progesterone is a naturally occurring sex hormone
      involved in the menstrual cycle and reproduction, and has been shown to reduce withdrawal
      symptoms when people stop using substances like cocaine and nicotine. It is not FDA approved
      for treating cannabis users and is considered an investigational drug in this study.
    

Detailed description: 
      Participants will complete a screening visit to determine study eligibility. Eligible
      subjects will be scheduled to begin 22 days of study participation. During the first week,
      participants will be randomly assigned to take either progesterone or placebo (inactive
      medication) twice a day, and to abstain from marijuana use. During this week, participants
      will upload videos of themselves taking their medication and performing saliva drug tests.
      They will collect and store additional saliva samples each morning for hormone testing. They
      will also participate in "CREMA" sessions (Cue Reactivity Ecologic Momentary Assessment)
      three times a day. These sessions include looking at stressful and neutral pictures and
      rating stress and craving. At the end of this week, participants will return to the clinic
      and participate in a stress task. For the next two weeks, participants will continue to
      collect saliva samples and participate in CREMA sessions. They will return at the end of the
      two weeks to return study supplies. Urine samples will be collected at each study visit.
    

Intervention name(s): Progesterone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 200 mg of exogenous progesterone twice a day; One dose of matched placebo twice a day.
Other intervention name(s): Prometrium
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Is Fructose Linked to Adiposity in Babies?
Condition: Obesity; Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Obesity
Study type: Observational

Summary: 
      The obesity epidemic has reached down into the infant and toddler age group. Dietary
      indiscretion during pregnancy, particularly in our current food environment, is a major risk
      factor for both gestational diabetes and neonatal macrosomia (>4kg newborns), which is itself
      a risk factor for obesity and metabolic syndrome in the offspring, possibly even during
      childhood. Temporal increases in fructose consumption in the last two decades coincide with
      temporal increases weight gain during pregnancy and with increased birth weight, including a
      higher prevalence of macrosomic newborns. Our central hypothesis is that higher fructose
      consumption during pregnancy is a risk factor for infant obesity and metabolic syndrome.
    

Detailed description: 
      The "fetal origins hypothesis" suggests that an individual's risk for obesity and metabolic
      disorders begins in utero; that fetal or early postnatal exposure to environmental factors,
      such as maternal nutrition or endocrine disrupting chemicals, adversely influences early
      development and results in permanent changes affecting energy storage and expenditure.

      Most studies on "fetal origins" of obesity in the offspring have focused on maternal high-fat
      diets; yet dietary fat consumption has not changed appreciably in the last two decades. One
      chemical exposure in both pregnant mothers and newborns that has been steadily increasing
      worldwide is fructose. Although ostensibly a carbohydrate, fructose is a potent lipogenic
      substrate, and in the hypercaloric state, as much as 30% of an ingested fructose load
      undergoes de novo lipogenesis to form triglyceride thus the effects of high-fat and
      high-fructose diets in terms of physiology and outcome are comparable. Substituting sucrose
      (fructose + glucose) for glucose alone increases visceral adiposity, insulin resistance, and
      dyslipidemia in adult animals and humans. For humans, fructose is ubiquitous in the food
      environment, especially for pregnant mothers, who are often counseled to drink juice during
      pregnancy, as it is deemed to be healthier than soda. The effects of fructose consumption
      during pregnancy on infant birth weight and adiposity has not yet been studied.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women between 18 to 40 years of age are eligible for this study
      
Keywords: neonatal adiposity; metabolic syndrome; fructose; maternal diet
Student Stress Levels and Management Through Meditation
Condition: Stress, Psychological
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      The professional program in Physical Therapy is rigorous and demanding on students, resulting
      in high levels of fatigue, stress, and sleep disturbance that can impact student performance
      and wellbeing. This project seeks to investigate ways to reduce student stress, monitor their
      quality of sleep and possibly enhance their learning through the practice of meditation.
    

Detailed description: 
      Utilizing a randomized controlled study design, a cohort of doctoral students in their first
      year of physical therapist education will undergo an 8 week intervention of a mantra-based
      Meditation (twice daily 20 minutes) with pre and post measures of blood pressure, sleep
      hygiene via the Pittsburgh Sleep Quality Index (PSQI) and stress surveys, including Perceived
      Stress Scale (PSS) and Visual Analogue Scale for stress (VAS), as well as daily logs of sleep
      to assess sleep quality.

      As many as 32 students (total number in cohort) per year may participate with 1/2 serving as
      controls and 1/2 undergoing the meditation practice for 8 weeks.

      Baseline measurement details:

      QUESTIONNAIRES: Each participant will be given a 1-item Visual Analogue Scale for stress
      (VAS), a 10 item Perceived Stress Scale (PSS), and a 9 item Pittsburgh Sleep Quality Index
      (PSQI) questionnaire. The VAS simply asks subjects to score how much stress they are feeling
      at that one moment in time on a 0-100 scale. The PSQI scores and assesses sleep quality and
      disturbances over a 1-month time interval and will be administered at the 4 week mark 1/2 way
      into the study as well as at pre and post intervention data collection events.

      BLOOD PRESSURE: Blood pressure will be measured individually in a separate room to ensure
      confidentiality. The BP measurements will be administered using an Omron professional
      automatic blood pressure monitor (model number HEM 907X) to ensure comfort/safety and the
      accuracy of the reading. Also for accuracy of blood pressure measurements subjects will be
      asked to refrain from caffeine (coffee, tea or chocolate), cigarettes/nicotine, or exercise
      that morning until after measurements are taken and avoid alcohol the evening prior. One
      identified researcher will take all blood pressure reading and will be blinded to which
      subjects are part of the research or the control groups.
    

Intervention name(s): Meditation Group
Intervention type(s): Behavioral
Intervention description(s): twice daily 20 minute mantra-based meditation practice for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Student Stress; Meditation; Sleep Quality; Blood Pressure
HIV Screening in the Emergency Department Setting
Condition: HIV Infections
MeSH terms: HIV Infections; Emergencies
Study type: Interventional

Summary: 
      Late diagnosis of HIV infection is believed to be responsible for high rates of HIV
      transmission. The purpose of this study is to determine whether targeted screening versus
      routine screening will identify a greater number of HIV infected participants. This study
      will also compare the costs of the resources used for targeted screening versus routine
      screening.
    

Detailed description: 
      Novel strategies are needed to reduce HIV transmission, particularly among individuals who
      are unaware of their HIV status. Emergency departments (EDs) routinely receive individuals in
      a medical setting where an opportunity exists to screen them for HIV. The purposes of this
      study are to determine whether the proportion of tested participants identified as HIV
      infected by targeted screening exceeds routine screening and to determine whether the program
      resources used per infected patient identified are lower for targeted screening than for
      routine screening.

      Participants will be recruited from the University of Cincinnati Emergency Medicine Clinical
      Trials Center. The existing ED-based clinical HIV counseling and testing program in a lower
      HIV prevalence area will randomly alternate between two strategies for offering testing to ED
      participants: 1) targeted screening based on self-reported HIV risk and 2) routine screening.
      Participants will be randomly assigned to the targeted or routine screening group based on
      their presence in the ED during randomized days and times.

      At study entry an interview, blood collection, and counseling will occur. Participants will
      be telephoned following their ED visit to be given their negative results. Participants with
      positive results will be asked to return to the ED for notification, counseling, and
      connections to subsequent care. Participants who are HIV infected will be transferred to the
      University of Cincinnati Infectious Disease Center for care.
    

Intervention name(s): Targeted Screening; Routine Screening
Intervention type(s): Other; Other
Intervention description(s): Selection method for screening is based on risk; Selection method for screening is not based on risk
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: HIV; Prevention; Public Health; Screening
Gaming Technology to Encourage Healthy Weight and Activity in Youth
Condition: Childhood Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      The goal of the proposed randomized controlled trial is to test the efficacy of exergaming
      (i.e. video gaming that involves physical activity) to reduce adiposity in overweight and
      obese children.
    

Detailed description: 
      The GAMESQUAD study is a 6-month, 2-arm randomized controlled trial among 46 overweight/obese
      children (aged 10 to 12 years) assigned to: 1) 3 hours/week of in-home exergaming or 2) a
      control group. An innovative aspect is the inclusion of a fitness trainer who will regularly
      video chat with the participant and virtually monitor gameplay. The study will advance the
      field by: 1) establishing the efficacy of exergaming to reduce BMIz among overweight and
      obese children and 2) demonstrating the potential of exergaming to reduce body fat and
      improve children's cardiovascular health.
    

Intervention name(s): Exergaming Condition
Intervention type(s): Behavioral
Intervention description(s): Participants are encouraged to meet the MVPA goal of 60 minutes/day, which will be gradually achieved beginning with 10 minutes/day in Week 1 and reaching 60 minutes/day in Week 6. Three hours each week will be devoted to exergame play, following prescribed exergame routines.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: BMIz; Exergaming; Cardiovascular Disease
Clinical Assessment of a Multifocal Contact Lens for People Who Use Reading Glasses Only
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional

Summary: 
      The purpose of this trial is to evaluate the use of multifocal contact lenses in people who
      use reading glasses only.
    


Intervention name(s): Lotrafilcon B multifocal contact lens
Intervention type(s): Device
Intervention description(s): Commercially marketed, silicone hydrogel, multifocal, soft contact lenses FDA-approved for up to 4 weeks recommended replacement schedule and up to 6 nights of extended (overnight) wear.
Other intervention name(s): AIR OPTIX® AQUA MULTIFOCAL
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Efficacy and Safety Study of XP19986 in Subjects With Symptomatic GERD
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate efficacy and safety of treatment with XP19986 Sustained Release (SR) Tablet
      compared to placebo in subjects with symptomatic GERD
    


Intervention name(s): XP19986 SR3, 20 mg QD; XP19986 SR3, 40 mg QD; XP19986 SR3, 60 mg QD; XP19986 SR3, 30 mg BID; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): XP19986 Sustained Release (SR) 20 mg tablet taken orally, once daily (QD) for approximately 32 days with titration and taper periods.; XP19986 Sustained Release (SR) 40 mg tablet taken orally, once daily (QD) for approximately 32 days with titration and taper periods.; XP19986 Sustained Release (SR) 60 mg tablet taken orally, once daily (QD) for approximately 32 days with titration and taper periods.; XP19986 Sustained Release (SR) 30 mg tablet taken orally, twice daily (BID) for approximately 32 days with titration and taper periods.; Placebo tablet taken orally for approximately 32 days with titration and taper periods.
Other intervention name(s): arbaclofen placarbil; arbaclofen placarbil; arbaclofen placarbil; arbaclofen placarbil; Sugar Pill
Intervention MeSH terms: Arbaclofen placarbil; Baclofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Assessment of Molecular Remission by ASO-qPCR After Bortezomib-dexamethasone (Vel/Dex) Followed by ASCT
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The primary objective of this study is to determine the rate of molecular remissions (MolR)
      assessed by ASO-RQ-PCR technique after induction treatment with bortezomib and dexamethasone
      (Vel/Dex) prior to high-dose therapy with melphalan and autologous stem cell transplantation
      (HDT-ASCT), and after HDT-ASCT in patients with multiple myeloma.
    

Detailed description: 
      HDT-ASCT is so far considered the standard of care for younger patients with multiple myeloma
      (MM). Current evidence indicates that quality of response is an important prognostic factor
      for long-term survival in MM. There are only very few data on molecular remissions (MolR)
      determined by the most sensitive technique, allele-specific-oligonucleotide - real-time
      quantitative - polymerase chain reaction (ASO-RQ-PCR) in MM, and there are no data available
      on molecular responses after bortezomib-based induction therapy followed by HDT-ASCT. The
      main aim of this study is to determine molecular response rate after ASCT following
      bortezomib-based induction treatment compared to a historical control group with conventional
      VAD induction treatment. A sensitivity of ASO-RQ-PCR technique will be compared to
      immunofixation and with immunophenotyping by flow cytometry.
    

Intervention name(s): bortezomib + dexamethasone
Intervention type(s): Drug
Intervention description(s): Bortezomib 1,3mg/m2 iv days 1,4,8,11, dexamethasone 40mg/day days 1-4, 9-12 in cycles 1- 2, then bortezomib 1,3mg/m2 iv days 1,4,8,11, dexamethasone 40mg/day days 1-4 in cycles 3-4, total number of cycles is 4, followed by HDT with ASCT
Other intervention name(s): VelcadeTM
Intervention MeSH terms: Dexamethasone; Bortezomib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bortezomib plus dexamethasone induction therapy; Autologous stem cell transplantation; Molecular remission
Trial of Protein Supplement on Vertebral Fusion in Posterior Spine Fusion Surgery
Condition: Spine Surgery
Study type: Interventional

Summary: 
      Receiving protein can affect the bone formation and maintenance by providing a structural
      matrix of the bone, optimizing the level of IGF-1, increasing intestinal calcium absorption,
      transferring phosphorous, and improving muscle strength.Therefore, protein may be effective
      on vertebral fusion by such mechanisms. In this trial patients undergoing elective posterior
      spine fusion surgery are divided into two groups of intervention or control.
    

Detailed description: 
      A randomized, double blind, controlled trial will be conducted in patients undergoing
      elective posterior spine fusion surgery in Tehran, Iran. After a full review of the inclusion
      and exclusion criteria and explanation of the risks and benefits of the study, written
      consent form will be completed. The participants are 80 eligible posterior spine fusion
      surgery patients, aged ≥ 18 years. Intervention patients will be received 36 grams of protein
      supplement along with diet containing 1.2 g/kg/day of protein for 30 days after surgery and
      control patients will be received Carbo Mass along with diet containing 1.2 g/kg/day of
      protein 30 days after surgery. Patients will be evaluated for occurrence of vertebral fusion
      and enhanced recovery after 3 months surgery.
    

Intervention name(s): protein supplement; Carbo Mass
Intervention type(s): Drug; Other
Intervention description(s): Three sachet of protein supplement to be mixed in with water used daily.; Three sachet of Carbo Mass supplement to be mixed in with water used daily.
Other intervention name(s): Pure-protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Protein supplement; Protein diet; Vertebral fusion; Enhanced recovery after surgery; Infection; Wound healing; Pain
Development and Testing of a New Generation of Diabetic Footwear
Condition: Diabetes Complications; Diabetic Neuropathies
MeSH terms: Diabetic Neuropathies; Diabetes Complications
Study type: Interventional

Summary: 
      This particular trial is looking to compare the effectiveness of two types of foot bed/ sole
      materials used within diabetic footwear.
    

Detailed description: 
      DiaBSmart as a project aims to generate, transfer and exchange the clinical, academic and
      production knowledge between the partners to create a new generation of diabetic footwear
      through a newly developed patient assessment system. The transfer of knowledge between
      various sectors ensures that the need of patients is considered and transferred effectively
      to product development using a scientific approach. The objectives include:(1) the design and
      development of an integrated system of DIABetic foot assessment (2) to validate the newly
      developed system using experimental methods (3) to develop a suitable material to meet the
      mechanical and clinical requirements (4) to evaluate the mechanical and clinical
      effectiveness of material choice in reducing the potential risk of foot complications. The
      Numerical, Experimental and Mathematical Analyses system will integrate all aspects of
      diabetic footwear including; clinical and biomechanical assessment, material choice and
      aesthetic design. Proposed interdisciplinary, inter-sectorial approach is unique and brings
      together the expertise from research institutions, industry and clinics. This project while
      enhancing the knowledge base in diabetic assessment; will have a clear impact on new product
      development leading to both clinical and economic benefits. The products include a new
      generation of integrated SMART /multi material midsoles and/or orthoses for diabetic
      footwear. Properties of the materials will be optimised with a view to minimise/ redistribute
      the pressure and hence the stress on the soft tissue in the critical plantar areas of the
      foot. Whilst significantly affecting the course of the disease, the products will aim to
      reduce the risk of limb loss in patients with diabetes, the most frequent cause of
      non-traumatic lower-limb amputations.
    

Intervention name(s): Footwear :PU; Footwear: MCP
Intervention type(s): Device; Device
Intervention description(s): One group of patients will receive "Footwear" with PU insoles; One group of patients will receive footwear with MCP insoles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Cytokines and Sevoflurane During Surgery
Condition: Cytokines; Inflammatory; Sevoflurane
Study type: Observational

Summary: 
      The aim of the present study was to evaluate the effects of anaesthesia with sevoflurane and
      surgery on cytokines response.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Thirty adult patients ASA I physical status were allocated in 2 grups: 15 volunteers, not
        submitted to anesthesia and surgery, and 15 patients scheduled for tympanoplasty or
        septoplasty anesthetized with sevoflurane at 2,5%. Blood samples were drawn at 4 moments:
        before induction of anaesthesia, before surgery, at 120 minutes after anaesthesia
        induction, and on the postoperative first day. Blood samples from volunteers were drawn
        only once.
      
Keywords: anaesthetic techniques, inhalation; sevoflurane; Cytokines; Immune response