bioihbjkbjnl/mcl2 huggingface dataset:
Oxytocin in Cocaine Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional

Summary: 
      Stress is likely involved in relapse to cocaine use. This project will investigate the role
      oxytocin may play in the stress response in cocaine-dependent men and women and examine how
      oxytocin may impact brain activity in individuals exposed to cocaine-related cues.
    

Detailed description: 
      Stress is an important predictor of relapse, and targeting stress-activated pathways may lead
      to therapeutic advancements in the treatment of substance use disorders. Oxytocin has been
      shown to promote trust, social bonding, and calmness; however, its potential effects have not
      been explored in cocaine-dependent individuals. Oxytocin receptors have been localized to
      brain regions that are activated by drug-paired cues and preclinical studies have shown that
      oxytocin attenuates the acute and long-term behavioral effects of psychostimulants. However,
      little is known about the role of oxytocin in mediating the affective response to
      cocaine-paired cues and associated neural activity in cocaine-dependent men and women. This
      project is a direct evolution from our previous SCOR-supported research. Our work has
      progressed from characterizing sex/gender differences in response to social stressors and
      cocaine cues in cocaine-dependent men and women, to our on-going work evaluating whether
      stress potentiates cue-induced craving and the impact of hormones on this response. The
      proposed study will investigate the role of oxytocin in the sex/gender differences in stress
      response and craving in cocaine-dependent individuals and preliminarily explore its
      therapeutic potential.
    

Intervention name(s): Oxytocin; Saline
Intervention type(s): Drug; Drug
Intervention description(s): intranasal administration, 40 IUs; intranasal administration, 40 IUs
Other intervention name(s): pitocin; pitocin
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: cocaine; substance abuse; drug abuse; cocaine dependence; drug addiction
Effects of Plant Concentrate Blend on Oxidative Stress in Healthy Humans
Condition: Healthy
Study type: Interventional

Summary: 
      This study evaluates the response to oxidative stress in healthy men and women after taking a
      blend of plant concentrate.
    

Detailed description: 
      The purpose of this study is to evaluate how blends of plant concentrates impacts oxidative
      stress in humans. Biomarkers of oxidative stress will be measured at three time points in 3
      month intervention. Based on our proof of concept dose response study, it was shown that the
      plant concentrate at the proposed dose can lower markers of oxidative damage and induce the
      production of antioxidant enzymes. We would like to confirm these findings and further
      evaluate the implication of increased antioxidative enzymes as seeing in our proof of concept
      study. An acute oxidative stress will be induced by a high glycemic drink and short aerobic
      exercise and the response during the induction of an acute oxidative stress as well as the
      recovery from an acute oxidative stress. Since the induction of antioxidative enzymes not
      only is linked to the protection of proteins and lipids from oxidative damage, it is also
      linked to the protection of DNA damage. Therefore, in this study, comet assay will be
      performed to evaluate the integrity of DNA.
    

Intervention name(s): AOX blend; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Antioxidant supplement
Other intervention name(s): Antioxidant blend; Placebo sugar pill
Intervention MeSH terms: Antioxidants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Antioxidant
Umbilical Cord Transplantation for the Elderly Population
Condition: Hematologic Malignancies
MeSH terms: Hematologic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      While cord blood transplants have been performed safely in elderly patients, many still
      relapse. The investigators propose to intensify the preparative regimen for this patient
      group in an attempt to decrease relapses, and combine this with an ex vivo expanded Umbilical
      Cord Blood (UCB) unit.
    

Detailed description: 
      Allogeneic stem cell transplantation is a life saving procedure in selected high-risk or
      recurrent hematologic malignancies and marrow failure syndromes. However its wide application
      is limited by availability of suitably HLA matched adult donors. Umbilical Cord Blood (UCB)
      has been increasingly used as an alternative hematopoietic stem cell source for these
      patients. To date, over 10,000 UCB transplants have been performed in both children32-38 and
      adults.35,39-44 Its advantages include easier procurement, decreased risk to donors, reduced
      risk of transmitting infections, the immediate availability of cryopreserved units, and
      acceptable HLA mismatches. The transplantation of UCB allows a greater degree of HLA
      mismatching without an unacceptably high incidence of graft versus host disease (GVHD). Adult
      patients receiving myeloablative cord blood transplants have a 90% chance of engraftment, but
      carry a 50% rate of transplant related mortality.
    

Intervention name(s): StemEx
Intervention type(s): Biological
Intervention description(s): For patients allocated to StemEx® arm:
Day -20: Start small (or equal) portion expansion at processing site. (II) Conditioning Phase
Day -6 to -1: Subject receives a RIC regimen containing Fludarabine, Cyclophosphamide and Total Body Irradiation (TBI) (III) Transplantation and Follow-up Phase
Day 0: CBU unmanipulated portion transplantation (for StemEx® arm) or unmanipulated CBU transplantation.
Day 1: StemEx® transplantation.
Day 2 to 3 years: Post transplant follow-up.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stem cell transplantation; Stem Cell expansion; Elderly
Asthma Control: Increased Physical Activity in Young Adults
Condition: Asthma in Young Adults
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Investigators want to study to see if patients who participate in a physical activity
      intervention involving increasing daily step counts will have better mini asthma quality of
      life questionnaire (Mini AQLQ) scores at the end of the study period compared to patients
      that are in the control group and do not increase daily step counts. Participants will be
      randomized into the two groups.
    

Detailed description: 
      The Control group (usual care group) of 75 patients will not participate in the intervention
      but will take an asthma control survey at baseline (point of enrollment into the study) and
      about 4-6 weeks after.

      The Intervention group of 75 patients who will participate in the intervention of step counts
      and take an asthma control survey at baseline (point of enrollment into the study) and about
      4-6 weeks after.
    

Intervention name(s): Physical Activity
Intervention type(s): Other
Intervention description(s): Intervention group participants will be enrolled in a standardized step-based program to gradually increase their physical activity. Daily steps will be measured via a pedometer application on a smartphone or wearable device, with a gradual increase in the goal on a weekly basis, with a target intervention of around 4-6 weeks in total. The first week's step count will be used to calculate a baseline step count for the week. At the start of each week, the participants will be asked to increase their daily step counts by 1,000.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety and Efficacy Study of Rituximab in Renal Transplantation
Condition: Renal Transplantation
Study type: Interventional
Phase: Phase 1

Summary: 
      Current strategies for the medical management of transplant patients are largely focused on
      the prevention and treatment of T-lymphocyte mediated processes. However there is an
      increasing evidence to suggest that B-lymphocytes have a role in the otherwise classic T-cell
      mediated rejection of transplants by there ability to act as antigen presenting cells and
      T-cell activators. Thus there is a significant medical need for effective therapies targeting
      B cells of transplant patients.One such potential therapy would be to use rituximab, a
      monoclonal antibody against B-cells in all renal transplant patients. In the present study
      the efficacy and safety of prophylactic rituximab is studied.
    


Intervention name(s): rituximab
Intervention type(s): Drug
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Kidney; Transplantation; Immunosuppression; Rituximab
Assessment of Correlation Between Changes of Shear Wave Elastography and Surface Electromyogram of the Masseter
Condition: Masseter Muscle Spasm
MeSH terms: Spasm; Trismus
Study type: Interventional

Summary: 
      Diagnoses and follow up of muscles diseases lack imaging. Severity assessment of masticatory
      dysfunction and follow up of treatment effectiveness is currently based only on clinical
      features. Supersonic ShearWave Imaging® is a new, non-invasive, non-irradiating and dynamic
      imaging technique that uses ultrasound and allows shear wave elastic modulus in a muscle in
      order to study its viscoelastic properties.

      In this study, the investigators study the correlation between changes of shear wave
      elastography modulus and surface electromyogram features of the masseters between rest and
      maximal voluntary contraction.
    


Intervention name(s): Ultrasound exam by Supersonic Shear Imaging® technique; EMG examination by electromyograph Keypoint system
Intervention type(s): Device; Device
Intervention description(s): Each of the two observers performs twice ultrasound examination and measures of the masseter thickness and its elastic modulus, at rest and maximal voluntary contraction.; Experimented neurologist performs EMG examination.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: shear wave elastography; surface electromyogram; masseter
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Doses of PTH134 in Post-menopausal Women
Condition: Post-menopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to provide information about the bone-anabolic response of PTH134 when
      administered orally, in comparison to Forsteo®, the sub-cutaneous form of teriparatide, the
      active ingredient in PTH134.
    


Intervention name(s): PTH134; Placebo; Forsteo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Teriparatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoporosis
Study of Lumasiran in Healthy Adults and Patients With Primary Hyperoxaluria Type 1
Condition: Primary Hyperoxaluria Type 1 (PH1)
MeSH terms: Hyperoxaluria, Primary
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of single-ascending doses (SAD) and multiple-ascending doses (MAD) of
      lumasiran in healthy adult volunteers and subjects with primary hyperoxaluria type 1 (PH1).
      In Part A, single ascending dose (SAD) part, healthy adults were dosed with lumasiran or
      placebo once. In Part B, multiple ascending doses (MAD) part, patients with primary
      hyperoxaluria type 1 (PH1) were dosed with lumasiran or placebo. All patients that initially
      received placebo received lumasiran after completing placebo dosing.
    


Intervention name(s): Lumasiran; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lumasiran will be administered SC once in Part A. In Part B lumasiran will be administered SC qM (Days 1, 29 and 57) or q3M (Days 1 and 85).; Matching placebo (sterile saline: 0.9% sodium chloride [NaCl]) will be administered SC once in Part A. In Part B matching placebo will be administered SC qM (Days 1, 29 and 57) or q3M (Days 1 and 85).
Other intervention name(s): ALN-GO1
Intervention MeSH terms: Lumasiran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: PH1; Primary Hyperoxaluria; RNAi therapeutic; siRNA; AGT
An Observational Study to Characterize Human Milk From Mothers Delivering Term SGA and AGA Infants.
Condition: Small for Gestational Age (SGA) Infants; Appropriate for Gestational Age (AGA) Infants
Study type: Observational

Summary: 
      This is an observational study to characterize human milk of mothers delivering term SGA and
      term AGA infants. This is an observational, exploratory, longitudinal (from birth to 6 months
      postpartum), 4 parallel groups, and multi-centric study. Total 300 subjects will be
      randomised in the study assuming 20% dropout, 240 subjects will be enrolled. The recruitment
      period for the study in India is for 6 months.
    

Detailed description: 
      This is an observational study to characterize human milk of mothers delivering term SGA and
      term AGA infants. This is an observational, exploratory, longitudinal (from birth to 6 months
      postpartum), 4 parallel groups, and multi-centric study. Total 300 subjects will be
      randomised in the study assuming 20% dropout, 240 subjects will be enrolled. The recruitment
      period for the study in India is for 6 months.

      The Primary Objective of the study is to characterize and quantify maternal milk composition
      from mothers of adequately nourished and under nourished status delivering term Small for
      Gestational Age (SGA) infants, compared to adequately-nourished and undernourished mothers
      delivering term Appropriate for Gestational Age (AGA) infants as defined in Fenton growth
      chart 2013.

      The secondary objective of the study is-

        1. Association of maternal milk components with dietary intake and nourishment status of
           the mother.

        2. Associations of maternal and infant clinical parameters to maternal milk nutrients.

        3. To explore and analyze additional functional milk components, such as triacylglycerol,
           cholesterols, carotenoids, vitamins, microbiota, peptide profile, microRNA, cytokines,
           growth factors and hormones.

      The subject will enroll in the study after signing the Informed Consent Form after delivery
      the infants (i.e. term AGA & term SGA) within 72 hours. Total Duration of the study for
      subject is 24 weeks. Sponsor will notify the end of study after 90 days of last subject last
      visit. Principal Investigator responsibility is to detect and document AE and SAE
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy (normal BMI) and undernourished (low BMI) women volunteers
Frequency of Pes Planus and Posterior Tibial Tendon Dysfunction in Patients With Ankylosing Spondylitis
Condition: Posterior Tibial Tendon Dysfunction; Pes Planus; Spondylitis, Ankylosing
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Flatfoot; Posterior Tibial Tendon Dysfunction
Study type: Observational

Summary: 
      This investigation aims to investigate the frequency of pes planus and posterior tibial
      tendon dysfunction in patients with ankylosing spondylitis.
    

Detailed description: 
      Posterior tibial tendon dysfunction is the most common cause of acquired pes planus deformity
      in healthy adults. The posterior tibial tendon stabilizes the hindfoot against valgus and
      eversion forces and acts as a support along the medial longitudinal arch. If the posterior
      tibial tendon loses its functionality, the other ligaments of the foot and the joint capsule
      gradually weaken as the height of the medial longitudinal arch decreases or disappears, and
      it develops with pes planus. The presence of pes planus and spondyloarthropathy are also risk
      factors for the development of posterior tibial tendon dysfunction.

      100 participants aged between 20-70 years with ankylosing spondylitis were planned to be
      included in this investigation. Posterior tibial tendon dysfunction frequency of patients
      with ankylosing spondylitis will be evaluated by both clinical examination and
      musculoskeletal ultrasonography device. The posterior tibial tendon will be evaluated by
      ultrasonography in terms of tendon diameter and fluid presence in 2 different locations in
      the retromalleolar area.

      Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis
      Functional Index (BASFI), Ankylosing Spondylitis Quality of Life (ASQoL) Scale, Functional
      reach test, Timed up and go test, Berg Balance Scale, Dynamic and static balance with the
      Sportkat device will be used as evaluation parameters. It was planned that the evaluations
      were made once.
    

Intervention name(s): Patients with Ankylosing Spondylitis
Intervention type(s): Other
Intervention description(s): Observational study, not applicable
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Outpatient clinic patients
      
Keywords: Posterior Tibial Tendon Dysfunction; Ultrasonographic Evaluation; Pes Planus
Effect of Endovascular Inferior Mesenteric Artery Embolization on Colonic Perfusion Prior to Rectal Surgery for Rectal Tumor or Sigmoid Colon Surgery
Condition: Cancer, Sigmoid; Cancer, Rectum
MeSH terms: Rectal Neoplasms; Sigmoid Neoplasms
Study type: Interventional

Summary: 
      The investigators hypothesize that a primary embolization, 3-4 weeks before surgery, would
      allow development of vascular collaterality, in particular for the marginal artery which will
      ensure a better colonic perfusion.
    


Intervention name(s): embolization of the inferior mesenteric artery; Inferior mesenteric artery ligation
Intervention type(s): Procedure; Procedure
Intervention description(s): proximal occlusion of the inferior mesenteric artery, before its divisional branches, by coils or plug 3-4 weeks prior to surgery.; Endovascular ligation of Inferior mesenteric artery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Budesonide Orodispersible Tablet vs. Placebo in Active Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to prove the superiority of a 6-weeks treatment with budesonide
      effervescent tablets versus placebo for the induction of clinico-pathological remission in
      patients with acute eosinophilic esophagitis.
    


Intervention name(s): Budesonide 1mg orodispersible tablet twice daily; Placebo orodispersible tablet twice daily
Intervention type(s): Drug; Drug
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Impact of Marketing of Alcohol Products on Young People
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      Impact of marketing of alcohol products on young people
    

Detailed description: 
      Responsible for 3.3 million deaths worldwide, alcohol consumption causes diseases (liver
      cirrhosis, cancers, etc.) and social problems (injuries, road accidents, alcohol dependence,
      etc.). With one of the highest consumption rate in Europe, alcohol is the second cause of
      avoidable mortality in France after tobacco (49.000 alcohol attributable deaths in 2009) and
      its social cost is estimated to 120 billion euros. French teenage population is particularly
      associated with heavy drinking patterns: in 2014, 49% of 17-year olds declared heavy episodic
      drinking.

      In that regard, several measures are recommended by health actors to combat this issue:
      minimum unit pricing, sales ban to minor, low blood alcohol concentration for drivers, etc. A
      specific measure concerns alcohol advertising restrictions. Some countries implemented
      alcohol advertising regulation laws (Poland, Sweden, Finland, Estonia, etc.), including
      France with the Evin law passed in 1991. This French law mandates advertising (and packaging)
      content to strictly convey factual information and objective qualities of alcohol products
      and thus bans attractive ads based on image and lifestyle evocations (seduction, power,
      etc.).

      The objective of this research is to investigate whether statutory framework for alcohol
      advertising (e.g., Evin law) can effectively protect people against misleading, suggestive,
      and appealing content. Little research has been conducted on this topic in spite of WHO's
      recommendations (most research has explored the influence of exposure to ads but not the
      impact of content).
    

Intervention name(s): MRI; Alcohol Use Disorders Identification Test
Intervention type(s): Device; Behavioral
Intervention description(s): Subjects review alcohol ads in different contexts (neutral context vs positive context such as parties and sport) and answer with buttons lever while being in the MRI to express their desire to consume alcohol or not.
Subjects will be exposed to 288 ads set up.; Questionnaire
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other