bioihbjkbjnl/mcl2 huggingface dataset:
Neuroendocrine Modulation of Metabolic Effects in Overweight Adolescents
Condition: Obesity
MeSH terms: Overweight
Study type: Observational

Summary: 
      This study will examine hormonal differences in ghrelin and growth hormone in obese and
      normal weight adolescents and their relationship to body composition and insulin resistance.
      The study will also investigate the effect of the macronutrient composition of a meal on
      postprandial ghrelin levels and whether ghrelin responses will predict the degree of hunger
      and caloric intake at a subsequent meal.
    

Detailed description: 
      Obesity is an epidemic that is striking people at younger ages than ever before. Obesity is
      associated with changes in the secretory patterns of several hormones including ghrelin,
      growth hormone (GH), and insulin, which have not been examined in the adolescent age group.
      Ghrelin, a primarily gastric hormone, increases appetite and is a GH secretagogue. This study
      will compare the alteration in secretion of ghrelin and GH in overweight and normal weight
      adolescent girls through frequent blood sampling and GH stimulation testing with growth
      hormone releasing hormone and arginine. The relationship between these hormones and insulin
      resistance, measured by 1H-nuclear magnetic resonance spectroscopy, and body composition,
      measured by dual energy x-ray absorptiometry and magnetic resonance imaging, will be
      investigated. This study will also determine the postprandial ghrelin response to test meals
      that vary by the type of predominant macronutrient, which may predict the degree of hunger
      and amount of intake at a subsequent meal. Understanding obesity-related changes in ghrelin
      and GH and their relationship to body composition, insulin resistance, and appetite will help
      in the development of strategies to reduce complications of obesity.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Obese and normal-weight girls between 12-18 years old
      
Biospecimen description: 
      Serum and urine collected
    
Keywords: Obesity, adolescent, ghrelin, growth hormone, cortisol
Research of Intensive Lifestyle Intervention for PCOS Patients With IGT
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome
Study type: Interventional

Summary: 
      Compare the efficacy between intensive lifestyle intervention and drugs (GLP-1 Receptor
      Agonists, metformin and acarbose) for PCOS patients with early onset diabetes in their
      metabolic and reproductive abnormalities treatment; clear the treatment effect and mechanism
      of intensive lifestyle intervention to PCOS.
    

Detailed description: 
      We designed a non randomized control study to compare the efficacy between intensive
      lifestyle intervention and drugs (GLP-1 Receptor Agonists, metformin and acarbose) for PCOS
      patients with early onset diabetes in their metabolic and reproductive abnormalities
      treatment We planed to enroll 48 patients.Overweight and obese PCOS patients with newly
      diagnosed IGT; PCOS diagnosis based on 1990 NIH criteria. Overweight / obesity diagnostic
      criteria according to WHO-WPR. IGT diagnostic criteria according to 1998 WHO diagnostic
      criteria. Except for serious complications (cardiovascular events and recent significant
      kidney or lung disease within 3 months), and had high blood pressure (>160/100mmHg), blood
      sugar and high blood lipids (glycated hemoglobin> 11%, triglycerides >600 mg/dl).

      Then we devided the 48 patients into 4 groups: intensive lifestyle intervention group, GLP-1
      group, metformin group and acarbose group, and each group 12 samples. Each group use specific
      treatment(showed as the group name) 3 months. Before and after the intervention, the blood
      samples would be collected to Glucose, Insulin, GLP-1, Glucagon, sex hormones, Blood
      chemistry for liver and kidney function ect, as well as the image examinations.

      We will compare the data of each patient, finally identify the treatment effect and mechanism
      of intensive lifestyle intervention to PCOS.
    

Intervention name(s): intensive lifestyle intervention; GLP-1 Receptor Agonists; Metformin; Acarbose
Intervention type(s): Behavioral; Drug; Drug; Drug
Intervention description(s): 3 months low GI diet and exercise; Use GLP-1 Receptor Agonists 3 months to treat PCOS; Use metformin 3 months to treat PCOS; Use acarbose 3 months to treat PCOS
Other intervention name(s): group 1; group 2; group 3; group 4
Intervention MeSH terms: Metformin; Acarbose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PCOS; intensive lifestyle intervention; IGT; drugs treatment
Study to Assess the Safety, Tolerability, and Pharmacokinetics of PXL770 in Healthy Subjects.
Condition: NASH - Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The study was planned in 2 parts: Parts A and B. In Part A, we tested 2 single doses of the
      study medicine in healthy volunteers: 500 mg and 750 mg. Part B was an optional part to test
      once-daily doses of the study medicine in healthy volunteers. We aimed to assess the safety,
      tolerability find out the side effects and blood levels of the PXL770.
    


Intervention name(s): PXL770
Intervention type(s): Drug
Intervention description(s): A single dose of 500 and 750 mg was administered to each subject.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Building Healthy Children
Condition: Teen Parenthood
Study type: Interventional

Summary: 
      This study will evaluate the effectiveness of providing a combination of evidence-based
      behavioral health treatments for mothers who gave birth to their first child prior to the age
      of 21 and who meet eligibility requirements and their children on prevention of child
      maltreatment and promotion of positive socioemotional development.
    

Detailed description: 
      Building Healthy Children is a collaboration of social service and health care agencies, each
      providing evidence-based services to intervention families in a seamless package. Low-income
      parents who gave birth to their first child when they were under 21 and who were not involved
      in the child welfare system were targeted as an at-risk group for whom home visitation
      services would offer optimal preventive and cost-efficiency outcomes. Services include
      Interpersonal Psychotherapy [IPT] for maternal depression and Child Parent Psychotherapy
      [CPP] for maternal-child relationship development and trauma treatment, and Parents As
      Teachers [PAT]. Families are provided a tiered complement of BHC services based upon risk and
      current need.

      Case management and outreach services are key to assure family engagement and full program
      participation. An assigned community outreach worker provides a consistent, nurturing
      relationship that helps retain families in the program and readies parents for the
      evidence-based treatments, movement towards goals, and behavior change. Outreach workers help
      to stabilize families and ensure compliance with medical appointments and recommended care.

      Most importantly, BHC home-based services are integrated with primary care practices:
      pediatric, family medicine, and federally qualified neighborhood health center. These
      comprehensive services are compared with a screening and referral only group in a randomized
      design. Integration with the child's medical home is an all-inclusive approach to improve
      child health and well-being and to achieve desired program outcomes.
    

Intervention name(s): Comprehensive preventive services; Screening and referral
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Combined evidence-based services:Parents as Teachers Home visitation, Child-Parent Psychotherapy, and/or Interpersonal Psychotherapy with outreach support
Other intervention name(s): Parents as Teachers Home visitation; Child-Parent Psychotherapy; Interpersonal Psychotherapy; Outreach support
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: teen parents; early childhood development; home visitation; evidence-based treatment
Impact of a Child-Parent Preoperative Accompanying Procedure on the Anxiety of Children Aged 5 to 12 With Scheduled Surgery
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      In France, during surgery, only 4% of parents are present at induction, most often for
      children with disabilities with iterative interventions. Some studies have shown that the
      presence of parents during induction decreases the anxiety of children, while others do not.
      Their conclusions all advocate preparing parents for this presence in the operating room in
      an accompanying course.
    


Intervention name(s): Experimental Group; usual care
Intervention type(s): Other; Other
Intervention description(s): Preparation for anesthesia (explanations, film, booklet), the presence of a parent in the operating room and the awakening of the child; Usual care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Periodontal Condition in Pregnancy and Low Birth Delivery Incidence
Condition: Pregnancy; Birth Weight; Periodontal Diseases
MeSH terms: Periodontal Diseases; Birth Weight
Study type: Interventional

Summary: 
      The objective of this study was the evaluation of periodontal condition in pregnant women and
      the effect of the treatment of periodontal disease upon low birth weight.
    

Detailed description: 
      This research was carried out in the following three centers: Samsun Birth and Children's
      Hospital, Department of Obstetrics and Gynecology of the Faculty of Medicine and Faculty of
      Dentistry of the University of Ondokuz Mayıs. 269 women in their first trimester were
      included in this study. Their ages ranged from 18-35 years, their height was above 150 cm and
      they have no history of any systemic disease. At the end of each trimester these measurements
      were performed: attachment level, probing depth, gingival index, plaque index, and bleeding
      on probing. According to the periodontal diagnosis the research population was divided into
      three groups: periodontally healthy women; periodontally diseased women, however rejection of
      treatment; periodontally diseased women, however acceptance of treatment.In this study
      one-way ANOVA, chi-square, conditional logistic regression analyses were used.
    

Intervention name(s): collection of periodontal records; pregnancy parameters; Initial Periodontal Therapy
Intervention type(s): Other; Other; Other
Intervention description(s): Clinic attachment level
Probing depth
Gingival index
Plaque index
Bleeding on probing were performed in all groups. These measurements were performed at the end of each trimester.; Parameters such as number of pregnancies, previous low birth weight, prenatal care, genital tract infection, use of antibiotics, smoking, tooth brushing habit and birth weight were evaluated.; Initial Periodontal Therapy is completed ( Supragingival and subgingival calculus elimination, root planning, polishing etc.) This treatment is considered to be the safest time for pregnant mothers was performed in 2 trimester.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pregnancy; Low birth weight; Gingivitis; Inflammation; Periodontitis
Regional Observatory on Metabolic Syndrome- LAZIO
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Observational

Summary: 
      The aim of the study, is to assess the prevalence of Metabolic Syndrome in Italy on a
      regional basis, defined according to NCEP/ATPIII Guidelines criteria.
    


Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinic
      
Keywords: Metabolic Syndrome; Lipids; Waist Circumference
Exercise Intervention for Employees of the University of Bern
Condition: Neck Pain; Musculoskeletal Diseases; Occupational Health; Efficiency; Exercise Therapy; Work Performance; Presenteeism
MeSH terms: Musculoskeletal Diseases; Neck Pain
Study type: Interventional

Summary: 
      As part of a Swiss National Science Foundation SNSF project (On-site multi-component
      intervention to improve productivity and reduce the economic and personal burden of neck pain
      in Swiss Office-Workers, NEXpro = Neck EXercises for productivity, SNSF no. 32003B_182389,
      BASEC no. 2019-01678), the investigators first developed a physiotherapeutic exercise
      intervention to improve the strength and mobility of the neck muscles. In the SNSF project
      NEXpro, the intervention took place on-site in the office. However, in view of the digital
      transformation, it is important to adapt the intervention delivery method to the new virtual
      work setting. The aims of the present project are therefore to implement, further develop and
      contextually adapt the exercise intervention in order to reduce musculoskeletal complaints
      and to reduce health-related presenteeism. The final product is a user-friendly virtual
      6-week short exercise intervention that employees of the University of Bern can use
      independently, regardless of time and place. The effectiveness of the newly developed short
      exercise intervention (pain reduction, reduction of presenteeism) will be assessed during a
      short pilot phase.
    


Intervention name(s): Exercise intervention
Intervention type(s): Other
Intervention description(s): The participants will carry out a physiotherapeutic exercise intervention over a period of 6 weeks. The exercise intervention is stored in a smartphone app (PhysiApp) and consists of different neck and shoulder exercises. The investigators will provide the training material to the participants and they may keep it after the end of the study. Participants can choose which and how many exercises they would like to do. However, the investigators ask participants to exercise at least three times a week for 20 minutes each time (a total of one hour per week) and to document the training afterwards in the smartphone app. In the first, third and sixth week, the investigators train together with the participants via a virtual platform (e.g. video call via Microsoft Teams) so that the correct execution of the exercise can be checked and questions can be clarified.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Rosuvastatin/Ezetimibe vs Rosuvastatin in Korean Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia
Condition: Type 2 Diabetes Mellitus; Hypercholesterolemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the efficacy and safety of rosuvastatin/ezetimibe combination therapy compared to
      rosuvastatin monotherapy in Korean patients with type 2 diabetes mellitus and
      hypercholesterolemia
    

Detailed description: 
      This study is to assess the efficacy and safety of Rosuvamibe® (rosuvastatin 5mg/ezetimibe
      10mg) vs Monorova® (rosuvastatin 10mg) treated for 8 weeks in Korean patients with type 2
      diabetes mellitus and hypercholesterolemia.
    

Intervention name(s): Rosuvamibe® Tab; Monorova® Tab
Intervention type(s): Drug; Drug
Intervention description(s): Rosuvastatin 5mg/ezetimibe 10mg qd for 8 weeks; Rosuvastatin 10mg qd for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Research Study to Investigate the Effect of NNC0174-0833 on a Birth Control Pill in Women Who Are Not Able to Become Pregnant
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      The study looks at how the study medicine affects the level in the blood of a birth control
      pill. The study also looks at how the study medicine affects the duration of emptying of the
      stomach. Participants will get 1 injection of study medicine once a week for 12 weeks by a
      study nurse at the clinic. The study medicine is injected with a thin needle in a skin fold
      in the stomach. In addition, participants will get 1 birth control pill per day for 8 days
      before the first dose of the study medicine and again after 10 weeks of dosing with the study
      medicine. Participants will also get a dose of acetaminophen before the first dose of the
      study medicine and again after 10 weeks of dosing with the study medicine. Acetaminophen is a
      mild painkiller but used here to assess the emptying of the stomach. The study will last for
      about 9 months, but participants will only be in the study for about 6 months. Participants
      will have 17 clinic visits with the study staff and some will be overnight visits. There will
      also be 3 phone calls with the study staff. At all visits, participants will have blood drawn
      along with other clinical assessments. Participants will be asked about their health,
      diseases and habits including mental health questionnaires. Participants must not be able to
      become pregnant if they want to participate in the study.
    


Intervention name(s): NNC0174-0833; Oral contraceptive (OC) tablets; Acetaminophen
Intervention type(s): Drug; Drug; Drug
Intervention description(s): NNC0174-0833 administered s.c. (subcutaneously, under the skin) once weekly for 12 weeks; 1 tablet daily on days 1-8 and days 79-86; Single dose of acetaminophen as part of a standardised meal on day 1 and day 79
Intervention MeSH terms: Acetaminophen; Contraceptive Agents; Contraceptives, Oral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study on the Intraject Instructions for Use
Condition: Healthy
Study type: Observational

Summary: 
      This study is designed to create an instruction set simple enough to be understood by
      migraine subjects as they were experiencing miagraine attacks.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers from the community
      
Keywords: Healthy volunteers
Phentolamine Mesylate as a Reversal of Local Anesthesics
Condition: Anesthesia, Local
Study type: Interventional

Summary: 
      Oraverse © (Phentolamine mesylate) is a product designed to reverse the effect of local
      anesthetics used in dentistry. Its main objective is to reduce the postoperative period
      during which the patient suffers from the lack of sensitivity in the perioral soft tissues,
      it is an obvious discomfort, a difficulty to speak or eat, and sometimes a risk of
      self-injury in the lips and / or tongue .

      The product was approved by the FDA in 2008 although the introduction in Spain has not
      occurred until December 2015. There are numerous studies that support its use, its
      effectiveness and safety, although none of the Spanish population, who have not yet had the
      opportunity to experience it.
    

Detailed description: 
      PURPOSE OF THE STUDY:

      To analyze the response of Oraverse in patients receiving complete oral disinfection
      treatment, after administration of Lidocaine 2% 1/80000, Articaine 4% 1/200000 or Bupivacaine
      0,5% 1:200000 in mandible, in comparison with the contralateral control side.
    

Intervention name(s): Phentolamine Mesylate 0.235 MG/ML [OraVerse]
Intervention type(s): Drug
Intervention description(s): compare effect of phentolamine mesylate in three arms
Intervention MeSH terms: Phentolamine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Three randomized groups
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: phentolamine mesylate; reverse local anesthesia
Fatigue and Sleep in Patients With COVID-19
Condition: Covid19
MeSH terms: COVID-19; Fatigue
Study type: Observational

Summary: 
      Recent studies show that patients who have contracted COVID-19 retain very significant
      fatigue after resolving the infectious episode. This fatigue may be explained by low-grade
      inflammation. There is more data for patients with COVID-19 who have been hospitalized than
      for non-hospitalized patients with milder forms.

      However, COVID-19 related fatigue would not only affect elderly people with severe
      cardiopulmonary consequences but also young subjects without severities. This notion is not
      very widespread and to date, COVID contracted by young subjects is considered to have very
      few consequences on their health.

      It is also known that the prevalence of sleep debt is significant in the general population
      and particularly in young people, and it is also known that sleep deprivation increases
      low-grade inflammation and facilitates the risk of viral contamination. The association
      between sleep deprivation, drowsiness and possibly low-grade inflammation raise questions
      about the mechanisms of fatigue in the general population.

      Investigators are also entitled to wonder to what extent the chronic sleep debt suffered by
      the French population can explain an increased risk of contamination by COVID 19 but also
      significant residual fatigue after COVID infection.

      Bordeaux University Hospital screens 2,000 subjects per day at risk of being infected by
      COVID, it would be very interesting to measure, in a population of young adults aged 18-45
      years, frequently exposed to a sleep debt, sleep hygiene (bedtime and wake-up times, sleep
      and wake-up schedules, and overall sleep satisfaction), average sleep duration, level of
      fatigue and drowsiness and to compare these thresholds between subjects with or without COVID
      19 according to nasopharyngeal PCR.
    


Intervention name(s): survey
Intervention type(s): Other
Intervention description(s): Self-questionnaires will be completed by the participants :
General health and mental health
Fatigue
Burn-Out
Sleepiness
Sleep hygiene
Symptoms of COVID
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patient or healthcare professional going to screening center to perform a PCR test for
        COVID-19
      
Keywords: COVID-19; fatigue
Effects of Salpingectomy During Laparoscopic Hysterectomy on Ovarian Function
Condition: Laparoscopic Hysterectomy
Study type: Interventional

Summary: 
      The purpose of this study is to assess the feasibility of performing a randomized clinical
      trial evaluating the effect of salpingectomy (removal of the fallopian tubes) during
      laparoscopic hysterectomy on ovarian function. The hypothesis is that removal of the tubes
      can prevent diseases of the fallopian tubes such as infection, hydrosalpinx (fluid-filled
      tubes)and additional invasive procedures such as further imaging work-ups and further surgery
      related to the tubes.
    


Intervention name(s): Salpingectomy
Intervention type(s): Procedure
Intervention description(s): Removal of the fallopian tubes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: ovarian function tests