bioihbjkbjnl/mcl2 huggingface dataset:
Dopamine Neurotransmission in Major Depression
Condition: Major Depressive Disorder; Anhedonia
MeSH terms: Anhedonia; Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Observational

Summary: 
      The overall aim of this study is to utilize an integrative research model in order to
      dynamically assess reward-related dopamine (DA) transmission in major depressive disorder
      (MDD) and test the role of dysfunctional DA release in depression and anhedonia.

      The first arm of this line of research (PET scan) aims to investigate phasic DA release in
      MDD during incentive motivation. The investigators will utilize an established molecular
      imaging technique to measure striatal DA release dynamically during performance of testing
      and control versions of a monetary incentive delay task, which involves anticipation and
      receipt of monetary rewards. In doing so, this experiment will link together independent
      lines of research that have associated depression with decreased hedonic responsiveness,
      impaired reinforcement learning and dysfunctional DA transmission. We hypothesize that,
      relative to matched controls, unmedicated MDD subjects will show reduced reward-related
      ligand (11C-raclopride) displacement. Reduced ligand displacement will be interpreted as
      indicating reduced task-induced release of endogenous striatal DA in response to
      reward-predicting cues and unpredictable reward in MDD subjects.

      In the second arm of this research (EEG recording), the investigators aim to probe the
      spatio-temporal dynamics of brain mechanisms underlying positive and negative reinforcement
      learning in MDD and their relations to phasic DA. Participants will perform the probabilistic
      stimulus selection task (PSST) while event-related potentials (ERPs) are collected. The
      investigators expect that, relative to matched controls, unmedicated MDD subjects will show
      reduced positive reinforcement learning, potentiated negative reinforcement learning, and
      larger (i.e., more negative) feedback-related negativity (FRN) in response to positive
      reinforcement (indicative of reduced DA transmission). Moreover, the investigators
      hypothesize that a more negative FRN in response to positive reinforcement will be associated
      with decreased striatal raclopride displacement (i.e., lower release of endogenous DA) as
      measured by PET in the first part of the study. This experiment will investigate the effects
      of blunted DA transmission on behavioral and ERP markers of both positive and negative
      reinforcement learning.
    


Observational model: Case-Control
Sampling method: Non-Probability Sample
Study population: 
        Individuals with Major Depressive Disorder and Healthy Controls
      
Keywords: Major Depressive Disorder; Anhedonia; Dopamine; Electroencephalography (EEG); Positron Emission Tomography (PET); Reward
Interaction Between Fluvoxamine and Sildenafil
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Aim of the study is to assess the interaction between sildenafil and fluvoxamine and its
      effect on the venous response to sodium nitroprusside.
    

Detailed description: 
      In a randomised, double-blind, placebo-controlled, cross-over study in healthy men we will
      assess the effect of oral fluvoxamine (50mg qd on day 1-3; 100mg qd on day 4-10) on
      sildenafil kinetics (single oral 50mg dose on day 11). Sildenafil plasma concentrations will
      be determined by LC/MS. We will also assess the effect of sildenafil on venodilation induced
      by a constant dose-rate of the NO-donor sodium nitroprusside (SNP) during preconstriction
      with phenylephrine (dorsal hand vein compliance technique).
    

Intervention name(s): sildenafil, fluvoxamine
Intervention type(s): Drug
Intervention MeSH terms: Sildenafil Citrate; Fluvoxamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Prevention
Anthropometric and Biomechanical Analysis of the Infant Foot
Condition: Child, Only
Study type: Interventional

Summary: 
      In the era of science and technology, footwear has become not only an essential item of
      clothing, but also another tool for the optimal development of children, the improvement of
      work and sports performance or the prevention and treatment of pathologies.

      The anthropometric characteristics of the child's foot differ considerably from those of the
      adult foot, in fact, it is not until the age of 18-19 years that the structure of the foot is
      finally consolidated. Therefore, it is essential that footwear manufacturers know these
      characteristics to achieve an adequate design.

      Current scientific evidence highlights the importance of considering the unique morphology of
      the infant foot, as well as the high functional demands to which footwear is subjected at
      these ages. There is a lack of studies that analyze in detail the shape of the child's foot.
    

Detailed description: 
      Given that the data we have so far comes from studies that are not very current and on small
      samples, there is a need to update these variables to transfer these results to the
      productive fabric.

      Therefore, the objective of this research is to carry out an anthropometric and biomechanical
      analysis of the infant foot in order to use these data in the creation of a standard last
      that respects its morphology.

      Subsequently, said last will be subjected to different fit tests to verify its correct
      adaptation to the foot in this population group.
    

Intervention name(s): Anthropometric study
Intervention type(s): Diagnostic Test
Intervention description(s): Once the 5 models of lasts have been produced in phase 1, certain shoe models will be designed and manufactured based on these lasts at random and at the free choice of the designers of a footwear company. These models will then be physically tested on children to analyze their effects on walking and walking.
Other intervention name(s): Design and manufacture of shoes and fit tests
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Children; Foot development; Foot posture; Paediatric foot; Shoes
Effect of Tegoprazan on Pharmacodynamics of Clopidogrel in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to evaluate the influence of tegoprazan on the pharmacodynamics of
      clopidogrel according to CYP2C19 genotypes following co-administration of tegoprazan and
      clopidogrel in healthy male volunteers.
    

Detailed description: 
      Evaluation Criteria:

        -  Pharmacodynamic assessments using P2Y12 assay

        -  Safety assessments with adverse event monitoring including subjective/objective
           symptoms, physical examination, vital signs, electrocardiogram, and laboratory test
    

Intervention name(s): Clopidogrel 75 mg; Tegoprazan 50 mg; Esomeprazole 20 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Clopidogrel 75 mg tablet; Tegoprazan 50 mg tablet; Esomeprazole 20 mg tablet
Other intervention name(s): Plavix; K-CAB; Nexium
Intervention MeSH terms: Esomeprazole; Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Tacrobell Capsule 1mg to Prograf Capsule 1mg
Condition: Immunosuppression
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate bioequivalence between tacrobell capsule 1mg and
      prograf capsule 1mg.
    

Detailed description: 
      This will be an open label, randomized, single dose, 2-treatment, 2-period crossover study in
      healthy volunteers.Study treatments will be administered under fasting conditions.

      Blood samples for the analysis of tacrolimus in blood will be obtained as follows:
      Predose(immediately prior to dosing), and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6,
      8, 12, 24, 48, 72 and 96 hours postdose.
    

Intervention name(s): Tacrobell capsule 1mg; Prograf capsule 1mg
Intervention type(s): Drug; Drug
Intervention description(s): 1 capsule, oral, over the period I&II(crossover); 1 capsule, oral, over the period I&II(crossover)
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tacrolimus; tacrobell capsule; prograf capsule; bioequivalence
Diaphragm Stretching Increases Spine and Thoracic Mobility
Condition: Healthy
Study type: Interventional

Summary: 
      Physical therapists have traditionally included various forms of manual therapy among the
      therapeutic approaches to spinal pathologies. The aim of this study was to evaluate the
      effect of diaphragmatic stretching on spine and thoracic movement in healthy adults.
    

Detailed description: 
      Spinal pain is a well recognized condition associated with significant personal and community
      burdens. Recent studies estimated the prevalence between 6 and 22% in neck pain, from 4-72%
      in thoracic pain and from 1.0% to 58.1% in low back pain, which increases with age. During
      the last decades numerous researches have been conducted on stretching effects, evidencing an
      increased muscle control, flexibility and range of motion. The main purpose of this
      investigation is to examine the effects of diaphragm stretching in spine and thoracic
      mobility in healthy subjects in order to apply the results in a specifics pathologies in
      future studies.
    

Intervention name(s): Diaphragm stretching.; Placebo.
Intervention type(s): Other; Other
Intervention description(s): A manual technique of diaphragm stretching during 7 minutes. The participants were situated in a seated position.; Disconnected ultrasound was used for the 7 min as sham treatment
Other intervention name(s): Manual technique; Placebo
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: stretching, diaphragm, spinal movement, thoracic movement
A Randomized Controlled Trail Comparing Subthalamic and Pallidal Deep Brain Stimulation for Dystonia
Condition: Dystonia
MeSH terms: Dystonia; Dystonic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to compare the subthalamic nucleus(STN) with the globus
      pallidus internus(GPi) as a stimulation target for deep brian stimulation(DBS) for medically
      refractory dystonia.
    

Detailed description: 
      In this prospective randomized controlled study,elecrodes were bilaterally implanted in STN
      and Gpi of 40 patients with dystonia.
    

Intervention name(s): Deep Brain Stimulation (DBS) of Gpi; Deep Brain Stimulation (DBS) of STN
Intervention type(s): Device; Device
Other intervention name(s): Rechargeable Neurostimulator; Rechargeable Neurostimulator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Therapeutic Plasma Exchange Followed by Convalescent Plasma Transfusion in Severe and Critically Ill COVID-19 Patients
Condition: COVID-19 Pneumonia; COVID-19 Respiratory Infection; Acute Respiratory Failure; Acute Respiratory Distress Syndrome
MeSH terms: COVID-19; Respiratory Tract Infections; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory Insufficiency; Acute Lung Injury
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Therapeutic plasma exchange (TPE) has been proposed as a rescue therapy in critically ill
      COVID-19 patients. The aim of this study is to determine whether combining TPE with
      convalescent plasma (CVP) transfusion early during the intensive care unit (ICU) stay,
      improves survival among this heterogeneous population.
    

Detailed description: 
      This single centre prospective, non-randomised controlled trial will be conducted in an 8 bed
      COVID-19 ICU and will include patients with severe COVID-19 pneumonia requiring ICU
      monitoring and therapy. 19 patients will be treated performing TPE followed by CVP
      transfusion while for 19 patients will receive standard treatment according to hospital
      protocols. TPE will be initiated during the first 24 hours after ICU admission, followed
      immediately by transfusion of CVP. The primary endpoint is survival at 30 days. Secondary
      endpoints include assessing the evolution of biomarkers, such as the partial pressure of
      arterial oxygen (PaO2) to fractional inspired oxygen (FiO2) ratio (P/F ratio), C reactive
      protein (CRP), lactate dehydrogenase (LDH) and ferritin at the 7-day follow-up.
    

Intervention name(s): Therapeutic plasma exchange
Intervention type(s): Other
Intervention description(s): The intervention is a combination between the procedure of Therapeutic plasma exchange and biological transfusion of convalescent plasma from donors that have have COVID-19
Other intervention name(s): Transfusion of convalescent plasma
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Single group, that is divided into two arms
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Therapeutic Plasma Exchange; Convalescent Plasma
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05690 (Care Program) (P05710)
Condition: Pregnancy; Neonates
Study type: Observational

Summary: 
      The objective of this follow-up study is to evaluate whether corifollitropin alfa (Org 36286)
      treatment for the induction of multifollicular growth in women undergoing controlled ovarian
      stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection
      (ICSI) is safe for pregnant participants and their offspring.
    

Detailed description: 
      This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal
      outcome of women who were treated with corifollitropin alfa or recFSH and became pregnant
      during the base study P05690 (NCT00702845). For this trial no study specific assessments are
      required, but information as obtained in standard practice will be used.
    

Intervention name(s): Corifollitropin alfa; recFSH (follitropin beta); gonadatropin releasing hormone (GnRH) antagonist ganirelix; human chorion gonadotropin (hCG); progesterone; placebo-recFSH (follitropin beta); placebo-corifollitropin alfa; open-label recFSH (follitropin beta)
Intervention type(s): Drug; Biological; Drug; Biological; Biological; Drug; Drug; Biological
Intervention description(s): Single injection of 100 μg corifollitropin alfa administered under protocol P05690; Daily recFSH administered under protocol P05690; GnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690; hCG 5,000 IU/USP or 10,000 IU/USP administered under protocol P05690; Under protocol P05690, progesterone was started on the day of oocyte pick-up (OPU) and continued for at least 6 weeks or up to menses. Participants received at least 600 mg/day vaginally or 50 mg/day IM.; Placebo-recFSH at the equivalent volume of 150 IU/day administered under protocol P05690; Single SC injection of placebo-corifollitropin alfa on Day 2 or 3 of the menstrual cycle, administered under protocol P05690; Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P05690
Other intervention name(s): SCH 900962; MK-8962; follitropin beta; Puregon®; Follistim®
Intervention MeSH terms: Hormones; Progesterone; Follicle Stimulating Hormone; Ganirelix
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women with an ongoing pregnancy at least 10 weeks after embryo transfer in base study
        P05690 (NCT00702845) were enrolled in this trial.
      
Keywords: Neonatal outcome; Congenital malformations; In-Vitro fertilization; Controlled ovarian stimulation; Follow-up
Fatty Acid Taste Thresholds: Caproic, Lauric, Oleic, Linoleic, Linolenic
Condition: Taste Sensitivity; Fatty Acid Type
MeSH terms: Hypersensitivity
Study type: Observational

Summary: 
      Differences in human oral sensitivity for caproic, lauric, oleic, linoleic, and linolenic
      acids will be explored. Prior work indicates that there may be a learning effect in measuring
      detection thresholds for free fatty acids. This study is designed to determine the number of
      visits necessary to attenuate this learning effect and also to test whether this effect
      continues across different types of fatty acids or is specific to each fatty acid. This will
      aid in understanding how many visits are required to obtain reliable data and if less
      expensive fatty acids can be used to attenuate learning before testing thresholds for more
      expensive fatty acids.
    


Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals between 18 and 60 years of age from any ethnic background who are in good
        health and are available for the next three months will be eligible.
      
Biospecimen description: 
      Saliva will be collected to obtain DNA for analysis of genes for fatty acid receptors and
      their potential correlation with sensitivity.
    
Keywords: taste; non-esterified fatty acids; threshold; sensitivity; human
Reassure Spot Respiration Rate Accuracy Compared to SOMNOScreen
Condition: Accuracy of Measurement of Respiration Rate
Study type: Observational

Summary: 
      A trial conducted within the company with a new non-contact respiration rate (RR) sensor. The
      device was compared for accuracy in RR measurement with a cleared device, the SOMNOScreen
      Easy, which uses chest effort bands.

      The RR was measured over a short duration on subjects sitting upright in a chair, with the
      non-contact sensor at various distances from the subject. A total of 20 subjects were tested,
      from both genders, selected to represent a wide range of age and body mass index
    

Detailed description: 
      The Reassure uses Radio Frequency (RF) waves to detect the small movements of the human body
      due to respiration. The reference device, the SOMNOScreen, uses chest effort bands. The
      Reassure is non-contact and so more comfortable and convenient for quick RR measurement, in a
      similar way that an Infra-Red thermometer is compared to a traditional under-the-tongue
      mercury thermometer.

      The aim is to explore the variations in the human body that could have an effect on the radio
      reflection from the human torso, and thus affect the potential detection and accuracy of
      breathing rate. Factors that could affect non-contact RF performance are:

        -  High Body Mass Index (BMI) could potentially reduce the chest wall movement during
           breathing, or alter the nature of the breathing.

        -  Elderly, thin skin (ie pensioner with low BMI) may have less RF reflection.

        -  Female breast tissue may have an effect on detection or accuracy.

      This was tested at a number of distances from the non-contact sensor and also with the
      subject having a thick comforter (duvet) laid across them.

      The test conditions were

        -  Distances of 0.5 m, 1.0m and 1.5m between the subject and the RF sensor.

        -  Additional test condition of comforter (duvet) on the subject when the distance from
           subject to sensor is 1.0 m.

        -  Each test condition carried out twice.

      The use of the comforter in one test condition is to confirm that the RR measurement by the
      Reassure is unaffected by the thickness of clothing or blankets being worn.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        20 persons selected to cover the range of age and BMI of 18 to 45
      
Keywords: Respiration rate
Effect of an Anti-ageing Supplement on Oxidative Stress
Condition: Healthy Volunteers; Age Group: 60-70; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This pilot study serves to investigate whether ProManna intake leads to any changes in
      baseline levels for oxidative stress markers. In addition, biomarker responses following
      oxidative stress challenge tests will be assessed in subjects taking ProManna versus placebo
      supplements.
    

Detailed description: 
      Ageing is characterized by a progressive decline in the efficiency of physiological function
      and by the increased susceptibility to disease and death. Most ageing-associated diseases
      develop silently for many years before symptoms appear, leading to irreversible pathological
      conditions. Examples of these diseases are Alzheimer's, Parkinson's, osteoporosis, diabetes,
      cardiovascular disease and also cancer. Typically, patients are treated when most of the
      damage has already occurred, and existing drugs can rarely cure these diseases, but merely
      slow down further progression of the disease. Therefore, preventive measures that may delay
      the onset of these diseases can hold the best promise for healthy ageing. of the most
      plausible and acceptable explanations for the mechanistic basis of aging is the "free radical
      theory of aging". This theory postulates that aging and its related diseases are the
      consequence of free radical-induced damage to cellular macromolecules and the inability to
      counterbalance these changes by endogenous anti-oxidant defences. ProManna is a novel and
      safe food supplement that aims to decrease free radical-induced damage, thereby contributing
      to healthy ageing.
    

Intervention name(s): ProManna
Intervention type(s): Dietary Supplement
Other intervention name(s): L-proline; D-mannitol
Intervention MeSH terms: Mannitol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention