bioihbjkbjnl/mcl2 huggingface dataset:
Remote Delivery of Weight Management by Phone and Social Media
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to compare two different weight management delivery methods,
      social media versus a traditional care model.
    

Detailed description: 
      Obesity is a major public health issue as 68% of the US population is either overweight or
      obese. Weight loss and weight loss maintenance is difficult. Traditionally, successful weight
      loss programs are weekly behaviorally-based clinics which utilize a combination of calorie
      restriction and physical activity. Traditional "face to face" weekly meetings may not be
      feasible for everyone.

      An alternative to provide weight loss and weight maintenance created by KUMC researchers uses
      weekly group phone conference calls. While this method produced equal weight loss with fewer
      burdens to participants when compared to the traditional "face to face" format, weight regain
      during maintenance was still high.

      This study will investigate a new delivery method (social media platform "Facebook") compared
      to the group phone conference calls. In the social media platform participants will be able
      to socialize with other participants in their group by commenting on posts from other
      participants or posting messages themselves. Social media delivered programs have potential
      to be a more a cost-effective approach to reach a large group of individuals.

      Participants who are eligible and decided to be in this study will take part in study related
      activities for 6 months.
    

Intervention name(s): Group Phone Calls; Social Media
Intervention type(s): Behavioral; Behavioral
Intervention description(s): University of Kansas Weight Management Program - Group Phone calls; University of Kansas Weight Management Program - Social Media (Facebook)
Other intervention name(s): KWMP-GP; KWMP-SM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Phase 1, Randomized, Controlled, Observer-blinded Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Adults Aged 18 to 49 Years
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 first-in-human, randomized, controlled, observer-blinded study with a 2-arm
      parallel design. Healthy adults aged 18 to 49 years of age with no history of pneumococcal
      vaccination will be randomized equally to receive either a single intramuscular dose of
      multivalent pneumococcal conjugate vaccine or a licensed tetanus, diphtheria, acellular
      pertussis combination vaccine (Tdap) (control group).
    


Intervention name(s): Multivalent; Tdap
Intervention type(s): Biological; Biological
Intervention description(s): Pneumococcal conjugate vaccine; Tetanus, diphtheria, and pertussis vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Biochemical Pregnancy Loss. A Multicenter Retrospective Study
Condition: Pregnancy Loss, Early
MeSH terms: Abortion, Spontaneous; Fetal Death
Study type: Observational

Summary: 
      Biochemical pregnancy loss (BPL) is a very frequent issue in human reproduction. After the
      implantation of the embryo, hCG disappears very soon from the maternal bloodstream and no
      evidence of a clinical pregnancy is seen. Different studies showed that factors such as age,
      oocyte and embryo quality, and endometrium receptivity may have something to do with the
      occurrence of biochemical pregnancy loss post assisted reproduction treatment.

      The main aim of this study is to evaluate the incidence of biochemical pregnancy loss (BPL)
      in three different cohort populations; patients undergoing frozen embryo transfer (FET) from
      own oocytes after preimplantation genetic testing for aneuploidy (PGT-A), patients undergoing
      FET from own and donated oocytes and with endometrial receptivity array (ERA), and patients
      undergoing FET from own or donated oocytes (without PGTA or ERA test).

      We will analyse the incidence of BPL in these populations and try to determine the role of
      the euploid status embryo in the first group, the endometrium in the second group and the
      third one as control group. We are waiting to find the value of both players in the origin of
      BPL.
    

Detailed description: 
      Human embryo implantation is a poorly understood process. Once the embryo implants in the
      endometrium, it starts to secrete hCG that can be measured in the maternal blood as early as
      9 days after implantation. Only a minimal number of pregnancies get to newborn, and the
      majority are lost before reach the first trimester (Larsen et al., 2013).

      We are looking for the role of the embryo after controlling its chromosomal ploidy, and the
      endometrium after controlling its transcriptomic expression. We will also use a no exposed
      group to the controlled euploid embryo factor neither endometrial factor that is the oocyte
      donation group. This analysis expects to provide more information about the key role of
      embryo or endometrium in BPL.
    

Intervention name(s): collect retrospectively data
Intervention type(s): Other
Intervention description(s): Analyse the incidence of BPL in these populations
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Infertile patients who come to participating centres for assisted reproduction treatments.
        Patients will be divided into 4 groups according to the treatment carried out: PGT-A, ERA,
        FET from own oocytes (CO) or FET from donated oocytes (CD).
      
Keywords: pregnancy; abortion; bioquemical
Influence of Smoking on Periodontal Healing One Year After Active Treatment
Condition: Periodontal Diseases; Smoking
MeSH terms: Periodontal Diseases
Study type: Observational

Summary: 
      The aim of this study was to investigate whether cigarette smoking had any impact on the
      clinical outcomes 1 year after active periodontal treatment. Eligible for the study were 5680
      individuals 20-85 years, referred to the specialised clinic for periodontal treatment at
      Gävle County Hospital between the years of 1980 and 2015. Before examination, all individuals
      filled in a questionnaire regarding their medical health, medication and smoking habits.

      Excluded were edentulous individuals and where clinical data 1-year after active treatment,
      or smoking habits were missing (n=1453). Complete data for analyses was available for 4227
      individuals.
    


Intervention name(s): Healing after treatment
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals 20-85 years, referred to the specialised clinic for periodontal treatment at
        Gavle County Hospital, Sweden between the years of 1980 and 2015.
      
Keywords: Smoking; Periodontal treatment; Periodontal disease; Healing
Local Wound Infiltration Plus TAP Block Versus Local Wound Infiltration Only
Condition: Colorectal Disorders
Study type: Interventional

Summary: 
      The TAP block is typically performed either with ultrasound guidance (TAP-US) or laparoscopic
      visualization (TAP-LAP): comparison between these two technics showed no differences in pain
      control and use of opioid analgesics.

      The investigators hypothesize that WI is non-inferior to WI + TAP-block with respect to
      postoperative pain.
    

Detailed description: 
      In colorectal surgery, laparoscopy and enhanced recovery after surgery (ERAS) programs have
      significantly improved the short-term outcomes (1). Although the laparoscopic approach
      reduces pain and recovery time, post-operative pain, nausea and vomiting still represent an
      issue. In order to reduce opioid related side effects, such as postoperative nausea and
      vomiting (PONV), constipation and prolonged post-operative ileus, non-opioid based multimodal
      analgesia have been recently introduced. Although epidural analgesia has gained good success,
      it does not seem to offer any additional clinical benefits to patients undergoing
      laparoscopic colorectal surgery compared to alternative analgesic technique within an ERAS
      program. Both local wound infiltration (WI) and TAP block are common techniques in multimodal
      postoperative pain treatment, and their association allows to achieve pain control despite a
      reduced use of opioid analgesics. Furthermore, in a recent single-blind prospective study TAP
      block resulted superior to wound infiltration alone. The TAP block is typically performed
      either with ultrasound guidance (TAP-US) or laparoscopic visualization (TAP-LAP): comparison
      between these two technics showed no differences in pain control and use of opioid
      analgesics.

      The aim of this study is to compare WI + TAP-LAP versus WI alone. The investigators
      hypothesize that WI is non-inferior to WI + TAP-block with respect to postoperative pain.
    

Intervention name(s): Wound infiltration plus TAP; Wound infiltration
Intervention type(s): Procedure; Procedure
Intervention description(s): TAP block: At the beginning of the main surgical procedure the surgeon will perform a TAP with ropivacaine infiltration, bilaterally in the anterior axillary line, between the costal margin and iliac crest in the intermuscular plane between the internal oblique and transversus abdominis muscles, the anesthesiologist under ultrasound guidance, the surgeon under laparoscopic guidance (two "pops" technique).
Wound infiltration : Wound infiltration of ropivacaine will be performed by the surgeon before skin incision.; Wound infiltration of ropivacaine will be performed by the surgeon before skin incision.
Other intervention name(s): ropivacaine; ropivacaine
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Aspirin on Gut Microbiome
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Regular use of aspirin may reduce the incidence of colorectal cancer (CRC). However, it is
      unclear through which mechanism aspirin exerts its effect, in whom it decreases CRC risk and
      in whom it causes side effects. Recently, the imbalanced gut microbiome was linked to
      inflammation and CRC risk. The main hypothesis for this study is that aspirin may decrease
      CRC risk via targeting the gut microbiome. The study will be a randomized placebo-controlled
      double-blinded design, recruiting 50 healthy subjects, 50-75 years old, from the PRospective
      Evaluation of SEPTin 9 (PRESEPT) cohort living in the greater Twin Cities area, who will
      receive either aspirin or placebo for 6 weeks.
    

Detailed description: 
      The pilot study will evaluate the feasibility of conducting a large randomized trial and
      estimate the effects of aspirin on the gut microbiome. The study will recruit 50 healthy
      subjects, 50-75 years old, from the PRospective Evaluation of SEPTin 9 (PRESEPT) cohort
      living in the greater Twin Cities area.

      The Primary Aim is to estimate the impact of a 3- and 6-week intake of once daily 325 mg
      aspirin on the composition of the gut microbiome using a randomized placebo-controlled
      double-blinded design, i.e. examine the change of microbiome over time within and between the
      subjects. The hypothesis for this aim is that in the aspirin arm versus the placebo arm, gut
      microbiome composition will shift towards a lower proportion of pro-inflammatory,
      CRC-predisposing bacteria (e.g. Fusobacteria) and higher proportion of anti-inflammatory,
      CRC-protective bacteria (e.g. butyrate-producing bacteria).

      The Secondary Aims are to examine the correlation between the aspirin-related changes in
      microbiome profile with the levels of circulating inflammatory biomarkers in urine and
      plasma. Within-individual and between-arm differences in microbiome composition will be
      compared after 3 and 6 weeks of aspirin intake. Also, the microbiome composition will be
      compared after 3-week and 6-week wash-out periods to test whether these periods are
      sufficient to restore gut microbiome composition to a pre-treatment level. This study will
      inform future crossover randomized studies focusing on CRC preventive interventions that will
      enable clinicians to identify optimal candidates for aspirin therapy for the purposes of CRC
      prevention using this accessible and cheap drug.
    

Intervention name(s): Aspirin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 325mg aspirin per day; placebo in matching capsules
Other intervention name(s): Acetylsalicylic acid (ASA)
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: aspirin; gut microbiome; inflammation; placebo; circulating biomarker
Human Study of Functional Meat Products
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      Nutritional clinical trial to evaluate the effectiveness of different functional meat
      products on the nutritional status of healthy people
    

Detailed description: 
      Different studies have revealed that many chronic pathologies including cardiovascular
      disease, diabetes, autoimmune disorders, cancer, obesity or neurological diseases, could be
      influenced by different dietary components, such as lipids. Thus, looking for ways to
      substitute healthier lipids for fats that contain high amounts of cholesterol, saturated
      fatty acids or trans fat, could be of great interest in the prevention of chronic diseases.

      Currently, meat and meat products, especially those where the fat is one of the main
      ingredients of the formulation, are perceived as unhealthy foods associated with increased
      risk of cardiovascular disease, cancer and obesity development. This is mainly due to their
      content of fat, trans fat, high percentage of saturated fatty acids, and cholesterol.
      Examples include sausages, meat spreads, salami or mortadella. Interestingly, despite the
      negative perception, meat and meat products continue to hold a relevant position in the diet
      of the developed countries. Indeed, the group "meat, poultry, deli meats and offal"
      contribute to the 17% of the total dietary fat intake of the Spanish population. Moreover,
      the consumption of deli meats and other meat products represents 5.8% of the total caloric
      intake. These values support the increased interest in evaluating the effect of improving the
      composition of these products in the prevention of disease.

      Overweight and obesity are main public health concerns worldwide. They both contribute to the
      development of numerous diseases increasing the morbidity and mortality rates of the adult
      population. In this context, it is suggested that the incorporation of healthier fats may be
      of great interest in the prevention of these conditions. Thus, usage of lipids from olive oil
      as fats replacements in meat products could be an interesting strategy for the prevention and
      treatment of overweight and obesity.

      A randomized, controlled, nutritional intervention is proposed to evaluate the effect of
      functional meat products on body composition and lipid profile in healthy individuals.
    

Intervention name(s): Functional meat products; Traditional meat products
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: functional meat products; hypocaloric fats; diglyceride; obesity
A Study Evaluating the Safety and Efficacy of QGE031 in Atopic Dermatitis Patients
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will assess the safety and efficacy of QGE031 in the treatment of moderate to
      severe atopic dermatitis patients. In addition, QGE031 levels in the blood will be measured
      and the effect of QGE031 on markers in the blood and skin will be evaluated. Comparisons of
      the effect of QGE31 will be made with placebo and also cyclosporine, a treatment already
      established as being effective in atopic dermatitis.
    


Intervention name(s): QGE031; Placebo; Cyclosporine A
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Cyclosporine; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Atopic dermatitis; Atopic eczema; Skin Diseases; QGE031
Gene Expression in Patients With Advanced or Metastatic Colorectal Cancer Receiving Bevacizumab
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may
      help doctors learn more about changes that occur in DNA and identify biomarkers related to
      cancer. It may also help doctors understand how patients respond to treatment.

      PURPOSE: This laboratory study is looking at gene expression in patients with advanced or
      metastatic colorectal cancer receiving bevacizumab.
    

Detailed description: 
      OBJECTIVES:

        -  Determine whether the balance of splice form expression alters susceptibility of tumors
           in vivo to respond to anti-VEGF therapy.

      OUTLINE: Tumor tissue samples collected on clinical trial E-3200 are analyzed for laboratory
      endpoints.
    

Intervention name(s): gene expression analysis; protein expression analysis; reverse transcriptase-polymerase chain reaction; immunoenzyme technique; immunohistochemistry staining method; immunologic technique
Intervention type(s): Genetic; Genetic; Genetic; Other; Other; Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples submitted for research from patients participating in E3200
      
Keywords: adenocarcinoma of the colon; adenocarcinoma of the rectum; recurrent rectal cancer; stage III rectal cancer; stage IV rectal cancer; recurrent colon cancer; stage III colon cancer; stage IV colon cancer
Dyphenhidramine Effect on Prevention of Sevoflurane Induced Post Anesthesia Agitation in Pediatric
Condition: Specified Sedative; Hypnotic
MeSH terms: Psychomotor Agitation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the effect of diphenhydramine on the prevention
      of sevoflurane induced emergence delirium/ agitation in pediatrics. The Investigators
      hypothesis is that it reduce the incidence of sevoflurane induced emergence delirium/
      agitation.
    

Detailed description: 
      This is an experimental clinical trial in double-blinded randomized controlled design on 50
      children aged 10 months to 21 months who underwent general anesthesia with sevoflurane for
      labioplasty surgery. Fifteen minutes before inhalation anesthetics were discontinued, the
      subjects were randomly given a placebo or a single dose of diphenhydramine 0, 5 mg / kg
      intravenously. Subjects were extubated and observed in the recovered space conscious for any
      agitation or emergence delirium and feasability to return to the ward. Agitation or emergence
      delirium was assessed by the Pediatric Emergence Agitation and Delirium Score (PAEDS) whereas
      feasability to return to the ward scored with the Steward score. When PAEDS> 10 patients were
      assessed to be agitated or having emergence delirium and administeres rescue tranquilizer
      ketamine 0.1 mg / kg. Total rescue tranquilizers and clinically significant adverse effects
      of drugs also recorded.
    

Intervention name(s): Diphenhydramine; normal saline; Ketamine; Sevoflurane; Bupivacaine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Intravenous Injection; Intravenous Injection; Ketamine 0,1 mg/kg intravenously used as rescue tranquilizer if the subject becomes agitated, repeated dose of 0,05 mg/kg every minute can be given if the agitation does not resolve, maximum ketamine dose for tranquilizer 0,25 mg/kg to prevent deep sedation; Sevoflurane as single sedation agent for general anesthesia in both arm. 8% Sevoflurane in 100% oxygen used as induction agent, and 2% sevoflurane in 50% oxygen used as maintenance agent; Bilateral extraoral infraorbital nerve block with 0,125% Bupivacaine as analgetic for operation and post operation.
Other intervention name(s): NaCl 0,9%
Intervention MeSH terms: Diphenhydramine; Promethazine; Ketamine; Bupivacaine; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Diphenhydramine; emergence agitation; pediatric anesthesia; PAEDS; Withdrawal
A Study to Assess the Pharmacokinetics and Safety of Different Forms and Formulations of AZD9496 in Healthy Subjects
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1 open label single centre study of AZD9496 administered orally in healthy
      volunteers. The study design involves single administration of different forms, formulations
      and doses of AZD9496. The study is designed to investigate these different AZD9496 variants.
      The study will evaluate the pharmacokinetic profiles and the safety and tolerability of the
      different forms, formulations and doses of AZD9496

      This is a fixed sequence study with 5-sequential treatment periods in healthy volunteers.
      Each volunteer will receive 5 single doses of AZD9496 in different forms, formulations and
      doses.
    

Detailed description: 
      A phase 1, open-label, single centre study to assess the pharmacokinetics, Safety and
      tolerability of different forms, formulations and doses of AZD9496 in healthy volunteers.
      This is a fixed sequence study with 5-sequential treatment periods. Each subject will receive
      5 single doses of AZD9496 in different forms, formulations and doses.

        -  Treatment period one will assess AZD9496 Variant A: 100mg.

        -  Treatment period two will assess AZD9496 Reference form: 100mg.

        -  Treatment period 3 will assess one of AZD9496 Variants, B, C or D: 100mg.

        -  Treatment period 4 will assess one of AZD9496 Variants, B, C or D: 100mg.

        -  Treatment period 5 will assess one of AZD9496 Variants A, B, C or D: *300mg. *Based on a
           review of pharmacokinetic and safety results from Treatment Periods 1, 3 and 4, a lower
           dose of 200 mg may be administered in Treatment Period 5.
    

Intervention name(s): AZD9496 (Reference); AZD9496 Variant A; AZD9496 Variant B; AZD9496 Variant C; AZD9496 Variant D
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): AZD9496 (Reference); AZD9496 Variant A.; AZD9496 Variant B; AZD9496 Variant C; AZD9496 Variant D
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast cancer; Healthy volunteers; Pharmacokinetics; AZD9496; Safety; Tolerability