bioihbjkbjnl/mcl2 huggingface dataset:
German Diabetes-Diet-Intervention and Energy Restriction-Trial (DDIET)
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Diet intervention according to the German Diabetes Risk Score in newly diagnosed type 2
      diabetes.

      This study aims to explore the effect of diet lacking red meat, but containing increased
      fibers and coffee (verum) versus standard recommendation (control) in a multicenter setting.
    

Detailed description: 
      This study is a randomised, multicenter controlled trial Our Aim is to test the effects of an
      8-week diet lacking red meat, containing increased fibers and coffee (verum) versus standard
      recommendation (control)in a multicenter setting.

      We are expecting that the verum diet will improve insulin sensitivity and insulin secretion
      due to reductions in visceral and hepatic fat along with improved adipocyte cytokine
      secretion profiles
    

Intervention name(s): diet intervention
Intervention type(s): Dietary Supplement
Intervention description(s): 8-week diet lacking red meat, but containing increased fibers and coffee (verum) versus standard recommendation (control) eating red meat.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: insulin sensitivity; type 2 diabetes; diet intervention
NettOpp: The Development and Evaluation of an App-based Selective Intervention for Adolescents Exposed to Cyberbullying
Condition: Cyberbullying
MeSH terms: Cyberbullying
Study type: Interventional

Summary: 
      The aim of the project is to develop and evaluate an app-based intervention for adolescents
      who have been exposed to cyberbullying. The overarching goal is to offer a low-threshold
      intervention, called NettOpp, that is easy accessible and free to use for every junior high
      school student who has experienced cyberbullying in Norway.
    

Detailed description: 
      The main aim of the intervention is to increase coping strategies for adolescents who have
      been exposed to cyberbullying. More specifically the aims are to increase 1) knowledge about
      cyberbullying, 2) help-seeking behavior, 3) coping strategies with cyberbullying, 4) to
      reduce mental health problems, and 5) cyberbullying, and 6) to increase self-esteem and the
      7) sleeping quality of the adolescents.

      To evaluate the mobile application three studies will be conducted: A lab test, a pilot
      study, and a larger effectiveness study with a follow-up examination after 3 months. The lab
      test will be conducted to examine the quality of the prototype of the app in order to find
      out if adjustments have to be made. Thereafter, a pilot study will be conducted with
      adolescents that were exposed to cyberbullying in the past six months. The pilot study will
      use a pre-post design.The effectiveness study will be conducted as a randomized controlled
      trial with an intervention group and a waiting-list control group.
    

Intervention name(s): NettOpp
Intervention type(s): Device
Intervention description(s): NettOpp is a mobile application for adolescents aged 11-16 years who have been exposed to cyberbullying or cyberaggression.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention and control group
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: cyberbullying; cyberaggression; mobile application
Epidemiology of Stress and the Metabolic Syndrome
Condition: Cardiovascular Diseases; Heart Diseases; Obesity; Hypertension; Hyperinsulinism; Insulin Resistance; Metabolic Syndrome X
MeSH terms: Cardiovascular Diseases; Heart Diseases; Metabolic Syndrome; Insulin Resistance; Hyperinsulinism; Syndrome
Study type: Observational

Summary: 
      To examine the effects of psychological stress on the metabolic syndrome.
    

Detailed description: 
      BACKGROUND:

      The metabolic syndrome identifies the clustering of lipid abnormalities, hypertension,
      hyperglycemia and abdominal obesity. It is a common and strong contributor to heart disease
      and diabetes and disproportionably affects older persons. Animal and small clinical studies
      have suggested that psychosocial stress is a risk factor for the metabolic syndrome.
      Underlying mechanisms may be through activation of the hypothalamopituitary-adrenal (HPA)
      axis causing hypercortisolemia, and, partly in turn, elevated inflammation and decreased sex
      hormone levels. However, longitudinal data showing that psychosocial stress indeed
      contributes to the onset and sequelae of the metabolic syndrome in the population at large,
      are lacking.

      DESIGN NARRATIVE:

      The primary objectives are to conduct data-analyses and biological sample analyses to examine
      the effect of psychosocial stress, as indicated by mood problems (depressive symptoms) and
      stressful social circumstances (poverty, negative life events, occupational stress, lack of
      emotional support), on the onset and sequelae of the metabolic syndrome. Secondary objectives
      are to examine underlying biological mechanisms in the effect of psychosocial stress on the
      metabolic syndrome. The investigators will use available data from two ongoing longitudinal
      community-based studies among older persons: the Health Aging and Body Composition (Health
      ABC) study (n=3,075, mean age=74 years, 52%=female, 42% African American) and the InChianti
      study (n=1,453, mean age=69 years, 56%=female). In both studies psychosocial stress and the
      metabolic syndrome are well defined, longitudinal data on sequelae (CVD events and diabetes
      onset) and onset of the metabolic syndrome are available, and potentially underlying
      biological variables were, or will be, assessed including 24-h urinary cortisol, serum sex
      steroid hormones (estradiol, testosterone, SHBG, DHEAS) and inflammatory markers (IL-6,
      IL-10, TNF-alpha, CRP, and various soluble cytokine receptors). The results of this study
      will help in designing future intervention trials that evaluate whether reducing stress
      and/or its physiological consequences, either by pharmacological treatment or behavioral
      intervention, could reduce incidence of the metabolic syndrome in the older general
      population.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Older persons
      
Biospecimen description: 
      DNA, blood
FGF-1 for Topical Administration for the Treatment of Diabetic or Venous Stasis Ulcers
Condition: Chronic Wounds; Diabetes; Venous Stasis Ulcers
MeSH terms: Varicose Ulcer; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      FGF-1 is being used for the treatment of patients with diabetic or venous stasis ulcers.
      Procedure includes topical administration of FGF-1 or placebo and evaluation of safety,
      pharmacokinetics, and wound improvement.
    

Detailed description: 
      Patients meeting eligibility criteria will be randomized to receive topical administration of
      either FGF-1 or placebo. Patients will be evaluated at days 1 and 7, post-treatment for
      safety, pharmacokinetics, and wound healing.
    

Intervention name(s): FGF-1
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic wounds; Diabetes; Ulcers; Arterial bypass; Angioplasty; Diabetic ulcers
Study of UX003 Recombinant Human Beta-Glucuronidase (rhGUS) Enzyme Replacement Treatment in Mucopolysaccharidosis Type 7, Sly Syndrome (MPS 7) Patients Less Than 5 Years of Age
Condition: Sly Syndrome; MPS VII; Mucopolysaccharidosis; Mucopolysaccharidosis VII
MeSH terms: Mucopolysaccharidoses; Mucopolysaccharidosis VII; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective was to evaluate the effect of UX003 treatment in pediatric MPS VII
      participants less than 5 years of age on safety, tolerability, and efficacy as determined by
      the reduction of urinary glycosaminoglycans (uGAG) excretion.
    


Intervention name(s): UX003
Intervention type(s): Drug
Intervention description(s): solution for intravenous infusion
Other intervention name(s): recombinant human beta-glucuronidase; rhGUS; Mepsevii ™; vestronidase alfa-vjbk; vestronidase alfa
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MPS 7; Sly Syndrome; MPS VII; Enzyme Replacement Therapy; Rare Disease; Mucopolysaccharidosis type 7; Lysosomal Storage Disease; Metabolic Disorder
Lower Extremity Muscle and Function in the Elderly: Study 2
Condition: Mobility Limitation
MeSH terms: Mobility Limitation
Study type: Interventional

Summary: 
      This research study is looking to compare the effects of two uniquely different power
      training interventions (high force, lower velocity versus low force, high velocity) on
      changes in mobility status among older individuals at risk for mobility disability.
    


Intervention name(s): High velocity low force Power Training; Low velocity high force Power Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Lower Extremity high velocity power training performed at lower external resistance (40% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions).; Lower extremity low velocity power training performed at high external resistance (70% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Resistance Exercise; Physical Activity; Mobility disability; Physical function; Muscle Strength; Older Adults; Mobility-Limited; Peak power and strength
Oral Teleconsultation
Condition: Dental Care
Study type: Interventional

Summary: 
      In this study we want to compare a dental diagnose during face to face consultation vs remote
      consultation with telemedicine device.
    

Detailed description: 
      Using Soprocare® camera, videos of patients' oral cavity are recorded and analysed remotely.
      200 patients have been included: 100 in Montpellier (France) and 100 in Kitakyushu (Japan).

      A classical face-to-face oral consultation is realized using ICDAS II classification. Then a
      student recorded 6 videos of patients' mouth: one video by sector, showing each face of
      molars and premolars in cario fluorescence mode of Soprocare® and one video of the maxillary
      and mandibular incisor-canine block in perio mode.

      In a third step, a remote dentist analysed videos and made a telediagnosis using the same
      classification. Dental hygiene and missing teeth are also noted in classical and tele
      diagnostic.

      The direct and the tele diagnostic are compared.
    

Intervention name(s): teleconsultation
Intervention type(s): Other
Intervention description(s): Determine the interest of teleconsultation in dentistry tool for the diagnosis of caries. Ie whether oral teleconsultations are of the same quality as conventional consultations for the diagnosis of caries ..
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Pilot Study of the Effect of Liraglutide on Weight Loss and Gastric Functions in Obesity
Condition: Obesity
MeSH terms: Obesity; Weight Loss
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was being done to assess the stomach emptying effect of a maximum dose of 3 mg
      Liraglutide compared to placebo in subjects who are overweight or obese. Liraglutide is a
      medication approved by the Food and Drug Administration (FDA) for routine clinical use.
    

Detailed description: 
      The objective of this study was to compare effects of liraglutide and placebo over 16 weeks
      on gastric motor functions, satiation, satiety and weight in obese patients. Subjects were
      randomized to liraglutide or placebo. Liraglutide or placebo was escalated by 0.6mg/day each
      week for 5 weeks and continued until week 16. At baseline and after 16 weeks' treatment, the
      investigators measured weight, gastric emptying of solids (GES), gastric volumes, satiation
      (maximum tolerated volume of liquid nutrient drink), and satiety. GES was also measured at 5
      weeks.

      During the study, the subjects received standardized dietetic and behavioral advice for
      weight reduction therapy. All subjects were given a standard text for information and met
      with a behavioral psychologist who has expertise in obesity treatment at the baseline visit
      and at visits at weeks 4,8, and 12. Additionally, the subjects had brief contact with a
      member of the study team every 4 weeks to inquire about their adherence to study protocol,
      any difficulties they were experiencing, whether they were reading their text assignments,
      and to answer any additional questions.
    

Intervention name(s): Liraglutide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Initiate at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6mg/day in weekly intervals to a dose of 3.0 mg/day is achieved (~4 weeks). Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
Other intervention name(s): Saxenda
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Mother's Gift Project
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This prospective randomized evaluation of pneumococcal vaccine immunization of pregnant
      mothers, followed by pneumococcal conjugate immunization of their children is designed to
      assess the effects of these strategies on the immunogenicity and safety of both vaccines. We
      hypothesize that maternal followed by infant immunization will be safe and will provide
      higher levels of antibody from birth through 12 months of age.
    

Detailed description: 
      This is a randomized vaccine evaluation in 4 groups of mothers and their infants, to assess
      the effect of maternal immunization on the infants' response to pneumococcal vaccine.
    

Intervention name(s): pneumococcal polysaccharide and protein conjugate vaccines
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: gestational immunization,; infant antibody,; cord antibody
LIFT With or Without Injection of BM-MNCs
Condition: Anal Fistula
MeSH terms: Rectal Fistula; Fistula
Study type: Interventional

Summary: 
      To improve the outcome of LIFT, some authors used a combined approach of LIFT. Pooled
      analysis of seven studies including 192 patients revealed a success rate of 83.5 % after
      combined LIFT approach. The use of bone marrow aspirate concentrate (BMAC) in surgery is not
      entirely new as it has been widely used in the treatment of bone defects, mandibular
      reconstruction, maxillary sinus augmentation and in critical limb ischemia.

      A previous study concluded that the use of BMAC to augment external anal sphincter repair
      strengthens wound healing by transferring cells responsible for healing directly to the site
      of repair. The current study aimed to assess the outcome of local injection of bone marrow
      mononuclear cells (BM-MNCs) in conjunction with LIFT as compared to LIFT alone in regards to
      healing rate, time to healing, and ultimate success rate.
    


Intervention name(s): bone marrow mononuclear cell injection; LIFT
Intervention type(s): Procedure; Procedure
Intervention description(s): bone marrow mononuclear cells were injected in the intersphincteric space and around the internal opening after ligation and division of the tract; The fistula tract is ligated in the intersphincteric space
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
sTMS for Substance Use-disordered Veterans
Condition: Cocaine Addiction; Opioid Addiction; Alcohol Addiction
MeSH terms: Substance-Related Disorders; Cocaine-Related Disorders; Opioid-Related Disorders; Alcoholism; Behavior, Addictive
Study type: Interventional

Summary: 
      The purpose of this study is to determine if synchronized transcranial magnetic stimulation
      is safe and tolerable in individuals with cocaine, opioid, or alcohol use disorders.
    

Detailed description: 
      All non-life-saving human research studies suspended by sponsor in response to COVID19 social
      distancing policies

      The goal of this proposal is to evaluate preliminary participant response to a pilot,
      controlled, feasibility study to evaluate changes in craving, substance use, and quality of
      life after 6 weeks of a low-risk non-invasive brain stimulation technique, called
      Synchronized Transcranial Magnetic Stimulation (sTMS), compared to sham, in Veterans with a
      substance use disorder (SUD). An important focus of this application will be evaluating the
      acceptability, tolerability, and safety of sTMS in this population. To the investigators
      knowledge, sTMS has never been used for SUDs, and holds considerable promise as a future
      treatment option for these prevalent disorders. However initial work in the acceptability,
      tolerability, and safety of this approach must be conducted first. This project is the first
      step towards the investigators long-term goal, which is to combine non-invasive brain
      stimulation with individualized psychotherapy or pharmacotherapy to reduce SUD problems and
      improve quality of life for Veterans.
    

Intervention name(s): sTMS; sham sTMS
Intervention type(s): Device; Device
Intervention description(s): sTMS will be delivered following NeoSync guidelines using the device user
manual; sham sTMS will be delivered following NeoSync guidelines using the device user manual
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double blind, sham controlled RCT
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Transcranial Magnetic Stimulation
A Research Study to Compare Two Different Forms of Once-weekly Semaglutide in Two Different Injection Pens
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will look at how 2 different semaglutide versions reach and stay in the blood after
      injection. The study aims to show similar levels of semaglutide in the blood when using the
      different semaglutide versions. Participants will get 1 of the 2 versions of semaglutide -
      which version is decided by chance. One version is the one that doctors already can prescribe
      and the other is the new version. Participants will get the medicine as an injection under
      the skin of the belly with a pen-injector. The type of pen-injector is different for the 2
      versions of semaglutide. Participants will receive 7 once-weekly injections in total. The
      study will last for about 80-106 days. Participants will have 19 study visits with the study
      doctor. For 2 of the visits, participants will stay in the clinic, 1 visit for 2 days and 1
      night and the other visit for 4 days and 3 nights. Participants may have to stop the study if
      the study doctor thinks that there are risks for their health. Participants cannot take part
      in this study if they have any disease or disorder that the study doctor thinks is a health
      problem. Women cannot take part if pregnant, breast-feeding or planning to become pregnant
      during the study period.
    


Intervention name(s): Semaglutide (administered by DV3396 pen-injector); Semaglutide (administered by PDS290 pen-injector)
Intervention type(s): Drug; Drug
Intervention description(s): Increasing doses of semaglutide given subcutaneously (sc, under the skin) in the stomach for 7 weeks; Increasing doses of semaglutide given sc in the stomach for 7 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Preanesthetic Forced Air Warming and Administration of Warmed Intravascular Fluid
Condition: Pregnancy
MeSH terms: Hypothermia
Study type: Observational

Summary: 
      The majority of women (> 60%) developed hypothermia and shivering during cesarean delivery.
      Core hypothermia may be associated with a number of adverse outcomes in patients, including
      shivering, wound infection, coagulopathy, increased blood loss and transfusion requirements,
      decreased metabolism and prolonged recovery. Shivering can result in interference with
      monitoring, increased tension on wound edges, and increased oxygen consumption.

      A previous study has shown several modalities to prevent hypothermia and shivering in
      patients undergoing cesarean delivery with spinal anesthesia. But, single modality
      intervention have shown marginal or no efficacy.

      Neuraxial anesthesia reduces the threshold for vasoconstriction and shivering. It often also
      produces a lower body sympathectomy that provokes a core to peripheral redistribution of body
      heat. It is difficult to treat the core to peripheral redistribution of body heat. However
      redistribution can be prevented by preanesthetic cutaneous warming. Prewarming hardly changes
      core temperature that remains well regulated, but it markedly increases peripheral tissue
      heat content. As a result, prewarming reduces the core to peripheral tissue temperature
      gradient and the propensity for redistribution after the induction of anesthesia.

      We therefore hypothesized that Combined modality active warming consisting of preoperative 15
      min of surface warming using a forced air warmer before spinal anesthesia and coloading of
      warmed intravenous fluid might reduce perioperative hypothermia and shivering in women
      undergoing cesarean delivery. Additionally, We tested the hypothesis that maintaining
      maternal normothermia increases newborn temperature and Apgar scores.
    


Intervention name(s): Prewarming using forced air warmer, warmed intravenous fluid
Intervention type(s): Behavioral
Intervention description(s): Combined modality active warming consisting of preoperative 15 min of surface warming using a forced air warmer before spinal anesthesia and coloading of warmed intravenous fluid in active warming group
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients scheduled for cesarean delivery under spinal anesthesia
      
Keywords: cesarean delivery with spinal anesthesia; Hypothermia and shivering; Active warming