bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Effect of Body Weight and Composition on Iron Absorption and Blood Volume
Condition: Obesity
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      A total of 75 subjects will be recruited for this study (25 normal weight, 25 overweight, 25
      obese). In each subject blood volume will be determined using the minimally invasive carbon
      monoxide-rebreathing method (substudy 1) and iron absorption will be measured from a test
      meal labeled with stable iron isotopes. The effect of ascorbic acid on iron absorption will
      further be determined using a second labeled test meal (substudy 2). In addition,
      inflammation, hepcidin and iron status will be determined. In order to study the effect of
      body fat content on blood volume and iron absorption weight and height will be measured, and
      body fat will de determined by dual energy X-ray absorptiometry.
    

Detailed description: 
      Obesity has repeatedly been shown to be a risk factor for iron deficiency. The reason for
      this is believed to be reduced iron absorption as a result of increased circulating hepcidin
      concentrations. However, the direct interactions between body fat mass, iron absorption,
      inflammation and hepcidin have not been studied to date. Whether the low iron absorption in
      obese subjects could be overcome by conventional methods to increasing iron absorption, e.g.
      the addition of ascorbic acid and whether a reduction of inflammation could improve
      absorption is further unclear. For the calculation of fractional iron absorption from oral
      doses of stable iron isotopes an estimation of blood volume is required. Several equations to
      estimate blood volume from weight and height or calculated body surface area or volume are
      available, but have rarely been validated or used in obese subjects. The aim of the described
      study is therefore: 1) to determine blood volume using the carbon monoxide-rebreathing method
      over a large BMI range and to use those values to validate existing blood volume equations;
      2) to measure iron absorption, hepcidin and inflammation in relation to BMI and body fat and
      3) to assess the effect of ascorbic acid on iron absorption.
    

Intervention name(s): labeled iron solution; labeled iron solution and ascorbic acid
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): labeled iron as ferrous sulfate (6mg/test meal); labeled iron as ferrous sulfate plus ascorbic acid (6mg:30mg /test meal)
Intervention MeSH terms: Iron; Ascorbic Acid; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
The Sub-Saharan Africa Regional Partnership for Mental Health Capacity Building
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      This is a 10-site cluster-randomized implementation science trial that compares two
      clinic-level implementation strategies to facilitate ongoing Ministry of Health efforts to
      scale up depression treatment within non-communicable diseases clinics in Malawi. Primary
      outcomes are clinical care indicators measured at the level of the visit (patient screened
      yes/no; depression treatment initiated if indicated yes/no; depression treatment algorithm
      followed at follow-up yes/no). Secondary outcomes are patient health outcomes measured at the
      level of the participant.
    

Detailed description: 
      This 10-site cluster-randomized implementation science trial compares the success of two
      clinic-level strategies in achieving high-quality integration of depression treatment into 10
      non-communicable diseases (NCD) clinics in Malawi. Clinics are randomized 1:1 to one of two
      clinic-level implementation strategies: a basic strategy involving an internal coordinator,
      and an enhanced strategy combining the internal coordinator with an external quality
      assurance monitoring and supervision team. During a pre-randomization run-in period (months
      1-5), all clinics receive the basic strategy. During a post-randomization intervention period
      (months 6-38), half of the clinics continue to receive the basic strategy and half receive
      the enhanced strategy. Visit-level data (for primary outcomes) and participant enrollment and
      follow-up (for secondary outcomes) are collected from all 10 clinics during the run-in and
      intervention periods.
    

Intervention name(s): Basic implementation package; Enhanced implementation package
Intervention type(s): Other; Other
Intervention description(s): The basic implementation package will involve identifying an internal coordinator who is one of the full-time on-site providers at the clinic. The internal coordinator provides mentoring to peers and support to leadership in implementing the treatment program and aligning it with clinic priorities.; The enhanced implementation package will combine the internal coordinator with an external quality assurance committee. This committee will complete quarterly audits at the facility to evaluate compliance with the depression treatment protocol as well as providing high-level support in implementing the treatment program through clinical expertise and limited on-site presence.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 10 clinics will be randomized 1:1 to either a basic or enhanced implementation package to support integration of evidence-based depression treatment.
Masking: None (Open Label)
Primary purpose: Health Services Research
To Investigate The Safety, Toleration And Pharmacokinetics Of Single Oral Doses Of PF-04531083 In Healthy Male Subjects
Condition: Pain
Study type: Observational

Summary: 
      The purpose of the study is to investigate the safety, toleration and pharmacokinetics of
      single oral doses of PF-04531083 in healthy male subjects.
    


Intervention name(s): PF-04531083
Intervention type(s): Drug
Intervention description(s): solution. doses to be selected based upon safety/tolerability/PK at preceeding dose
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        young, healthy male volunteers
      
Biospecimen description: 
      Blood
    
Keywords: Inflammatory pain
Noradrenergic Activity, Cognition and Major Depressive Disorder
Condition: Major Depressive Disorder; Early Life Trauma
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      This study investigates influences of nordadrenergic activity on cognition in patients with
      major depression regarding influences of early life stress.
    

Detailed description: 
      Stress plays a major role in the development and maintenance of major depression disorder.
      Indeed, various studies demonstrated maladaptive changes in physiological stress regulation
      systems of depressive patients, i.e. in the hypothalamus-pituitary-adrenal axis and the locus
      coeruleus-noradrenergic system. On a central level, changes of the locus
      coeruleus-noradrenergic system have been demonstrated.This seems to be the case especially in
      depressive patients with early life traumata. Comparable to the
      hypothalamus-pituitary-adrenal axis, the locus coeruleus-noradrenergic system influences not
      only the physiological stress response, but has also central influence with effects on
      cognitive functions. Indeed, noradrenergic effects on cognitive functions such as attention,
      learning and memory have been demonstrated in healthy individuals. Even though deficits in
      cognitive domains are core symptoms of major depression, the relationship of the
      noradrenergic system and cognitive processes has rarely been investigated so far.

      In this project, the investigators will examine noradrenergic influences via administration
      of the alpha2-receptor blocker yohimbine on cognitive and emotionally relevant processes in
      depressive patients and controls. Additionally, the investigators will examine the influence
      of early life traumata on these relationships. Thus, the investigators will examine
      participants with and without major depression and with and without early life stress.

      Results of this study will improve the understanding of cognitive dysfunctions associated
      with the noradrenergic system in patients with major depression.
    

Intervention name(s): yohimbine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): single low dose treatment; single control treatment
Intervention MeSH terms: Yohimbine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Gestational Diabetes Mellitus and Cardiometabolic Syndrome in Offspring
Condition: Gestational Diabetes Mellitus
MeSH terms: Diabetes, Gestational; Diabetes Mellitus; Metabolic Syndrome
Study type: Observational

Summary: 
      Gestational Diabetes Mellitus (GDM) has long been known as leading to macrosomias, neonatal
      hypoglycemias and other complications which are treatable and preventable. Nowadays, GDM is
      recognized as an entity with long-term serious sequels to the mother (GDM is considered a
      forerunner of type 2 diabetes) and her offspring. Indeed, according to the programming
      hypothesis, GDM sets the stage for metabolic syndrome, obesity, type 2 diabetes and
      hypertension. However, these cross-sectional studies failed to control for maternal disease
      history and genetic background although heredity is a major epidemiology risk factor of type
      2 diabetes. Also, studies usually refer to traditional markers such as BMI, blood pressure,
      lipids profile and oral glucose tolerance test (OGTT); none explored inflammatory biomarkers
      and adipokines in-depth, despite the possible link between their presence and the development
      of metabolic and cardiovascular diseases in GDM offsprings.

      Exclusion of genetic confounding factors will help establish the role of GDM as an
      independent marker of cardiometabolic risk in GDM offspring. It is highly relevant to
      identify GDM as a risk factor for cardiometabolic diseases, given the worldwide obesity
      epidemic, the alarming prevalence increase of GDM and its serious sequels to both mother and
      offspring.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Offspring born from GDM pregnancies and their siblings born to the same mothers but from
        non-GDM pregnancies.
Efficacy of Metacognitive Training for Schizophrenia - a Study Protocol
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Metacognitive training (MCT) for schizophrenia has been used in several countries, but its
      efficacy remains unclear. MCT is a program group that consists of changing the cognitive
      infrastructure of delusions.

      This study aims to evaluate the efficacy of the Portuguese version of the metacognitive
      training programme and its effects on psychotic symptoms, insight to the disorder and
      functionality
    

Detailed description: 
      A randomized controlled trial that will be realized in six psychiatric institutions of
      Portugal. Pilot study will be carried out initially. The sample will be constituted by
      individuals diagnosed with schizophrenia (experimental group (n=30) and control group (n=30).
      The evaluation instruments will be utilized are PSYRATS, BCIS, PSP and WHODAS 2.0 applied to
      both groups in three different moments. In experimental group the eight MCT modules will be
      applied over four weeks.

      The objective is to compare the outcomes associated with "treatment-as-usual" and the
      benefits of implementing the Metacognitive Training for Schizophrenia.

      The hypothesis to be validated in this trial are:

        -  the schizophrenic patients who integrate the experimental group and participate in the
           MCT program will reduce the severity of psychotic symptoms and will present a better
           insight to disease and a better functioning on the final of the program than the control
           group;

        -  in participants that participating in the MCT program, the psychotic symptoms decrease
           at the end of the program and in the follow up (three months later) and the awareness
           for the disease and functioning improves.
    

Intervention name(s): Metacognitive Training in Schizophrenia (MCT); Treatment As Usual (TAU)
Intervention type(s): Behavioral; Other
Intervention description(s): MCT is a group program with eight modules referring to common cognitive and biases in solving problems in schizophrenia. The following topics of MCT are: attribution blaming and taking credit (module 1), jumping to conclusions (modules 2 and 7), changing beliefs (module 3), deficits in theory of mind and social cognition (modules 4 and 6), overconfidence in (memory) errors (module 5) and depression and low self-esteem (module 8). Each session lasts 45 to 60 minutes and follows a protocol defined in the manual "Metacognitive Training for Psychosis (MCT)" that is currently available in 35 languages (available in www.uke.de/mkt).; In both groups will be maintained the TAU.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Metacognitive Training For Schizophrenia
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: schizophrenia; metacognitive training; insight; positive symptoms; functioning
Automated Tele Counseling for Screening Mammography
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose and aim of this study is to test the use of a computer-based, automated
      telecommunications system and its effectiveness in increasing the rates of regular screening
      mammography among women ages 50-74. The system will not only help in scheduling appointments
      but will help women in overcoming any barriers that may deter them from having the procedure
      at all. The programs are designed to be user friendly and easy to implement in clinical
      practice.
    

Detailed description: 
      The primary goal of this project is to evaluate the effectiveness and acceptability of a
      computer-based telecommunications system for increasing rates of regular screening
      mammography among women ages 50-74. The Telephone-Linked-Communications for Mammography
      Screening (TLC-M) is designed to educate, advise and motivate women to have regular screening
      mammograms. There will be two versions of TLC-M: one for women who are coming due for their
      annual screening mammography ("pre-due" women) and one for women who have missed their annual
      mammogram ("past-due" women). TLC-M uses a real human voice to speak to the women on the
      telephone; the subjects communicate by using the touch tone keypad on their telephones. The
      intervention will consist of up to three automated telephone conversations. During the call
      TLC-M assesses the woman's willingness to have a mammogram, helps interested women schedule a
      mammogram, and identifies and addresses difficulties or barriers she might have in getting a
      mammogram. This study will consist of two linked randomized controlled trials. We will
      recruit 2,120 participants over 12 months from two radiology departments. Three to four
      months prior to their due date for an annual screening mammogram, these women will receive a
      reminder letter to schedule a mammogram. In addition, a random sample of them will use TLC-M.
      All participants in this "pre-due" intervention study will be evaluated 3 months after their
      due date to determine whether or not they obtained a mammogram. Of the women who received the
      letter only in the first trial, those who did not obtain a mammogram during the observation
      period will enter a "past due" intervention trial. These women will be randomly assigned to
      receive a "past due" reminder letter or to use the TLC-M. Four months later, participants
      will be evaluated to determine whether they had a mammogram. For both trials mammography
      rates of those women who used the TLC-M and those who did not will be statistically compared.
    

Intervention name(s): Breast Cancer Screening Compliance
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Keywords: automated telephone system; breast cancer; cancer prevention; intervention; mammography; screening
A Trial to Explore Acceptance and Performance of Using a Digital Medicine System With Healthcare Professionals and Adults With Schizophrenia, Schizoaffective Disorder, or First Episode Psychosis on an Oral Atypical Antipsychotic
Condition: Schizophrenia; Schizoaffective Disorder; First Episode Psychosis
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Digital medicine systems (DMS) have been designed to assist individuals with the management
      of their daily health, wellness, and medication use. The DMS is being developed as a
      healthcare management tool to precisely measure medication adherence and to potentially
      enhance adherence.
    

Detailed description: 
      The advancements in the treatment of mental health patients with DMS will enable healthcare
      professionals to assess suboptimal adherence and make more informed treatment decisions. In
      addition to these improvements, it will also provide a platform for engagement between
      participants, healthcare professionals, and caregivers/support persons.

      Participants who entered the trial were treated with one of the oral atypical antipsychotics
      defined in the trial (aripiprazole, olanzapine, quetiapine, or risperidone [though no
      participant took risperidone in this trial]). The treatment medication decision was
      determined by the healthcare professionals.
    

Intervention name(s): Digital Medicine System; Aripiprazole; Olanzapine; Quetiapine; Risperidone
Intervention type(s): Device; Drug; Drug; Drug; Drug
Intervention description(s): DMS components: a CoE product consisting of an approved antipsychotic medicinal product co-encapsulated with Conformité Européenne (CE)-marked miniature ingestible event marker in tablet; a CE-marked compatible medical device (a Proteus Patch [Disposable Wearable Sensor Version 5]); proprietary medical software (a local and remote computing application).; Dosage determined by the healthcare professionals.; Dosage determined by the healthcare professionals.; Dosage determined by the healthcare professionals.; Dosage determined by the healthcare professionals.
Intervention MeSH terms: Olanzapine; Risperidone; Aripiprazole; Quetiapine Fumarate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Digital Medicine System
Terlipression Prevent Developing of Acute Kidney Injury During Upper-gastroentestinal Bleeding
Condition: Cirrhosis, Liver; Upper Gastrointestinal Bleeding
MeSH terms: Liver Cirrhosis; Gastrointestinal Hemorrhage; Acute Kidney Injury; Hemorrhage; Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators studied the renal function index level in terlipressin treated cirrhotic
      patients with upper-gastrointestinal bleeding at different time point.
    

Detailed description: 
      54 cirrhotic patients with uppre-gastrointestinal bleeding were entrolled and were
      distributed into terlipressin group and control group at 1:1 rate. Patients in Terlipressin
      group received 1mg/6h of terlipressin intravenously for 5 days, and patients in control group
      recerved 1mg/12h of Somatostatin intravenously for 5 days.

      At enrollment, 24h,48h,72,and 1week, the renal function index level( serum creatinine,urine
      biochemistry and Urinary tubule injury index etc) were tested.
    

Intervention name(s): Terlipressin; Somatostatin
Intervention type(s): Drug; Drug
Intervention description(s): Evaluate the effect of Terlipression on the occurance of acute kidney injury in patients with upper-gastroentestinal bleeding; Somatostatin
Intervention MeSH terms: Terlipressin; Somatostatin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: liver cirrhosis; upper gastrointestinal bleeding; acute kidney injury; urinary IL-18
The Effect of a Web-based Simulation Application
Condition: Self Confidence; Knowledge, Attitudes, Practice; Satisfaction
Study type: Interventional

Summary: 
      Cardiopulmonary resuscitation (CPR) training for nursing students is important. The
      importance of using computer-assisted simulation in gaining skills for basic life support
      applications is increasing. In addition to the use of simulation-based teaching methods in
      many different fields, it is seen that they are also used for the development of
      cardiopulmonary resuscitation practices of students and produce effective results.The aim of
      the study is to evaluate the effect of a web-based simulation application used in basic life
      support education on the level of knowledge, satisfaction and self-confidence of nursing
      students.
    

Detailed description: 
      This research was conducted with 60 nursing student (intervention group: 30, control group:
      30). The study is a mixed method type randomized controlled intervention study in which
      quantitative and qualitative research methods are used together.The quantitative data were
      obtained by using the ""Basic Life Support Knowledge Form", "Basic Life Support Skill Form",
      "Student Satisfaction and Self Confidence in Learning Scale, Perceived Learning Scale" , and
      the qualitative data were collected by using the "Semistructured Interview Form" in focus
      group sessions.
    

Intervention name(s): Intervention group
Intervention type(s): Other
Intervention description(s): They use Web-based Simulation Application for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study was conducted with a mixed-method design. In this study, there are two groups as intervention group and control group. Investigator, administered not any application to control group. Intervention group will use the web-based simulation application for 4 weeks.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Basic life support; Web based simulation