bioihbjkbjnl/mcl2 huggingface dataset:
Rutgers Pilot for PREDICT- Patient POC Test
Condition: SARS CoV 2 Infection
MeSH terms: Infections; COVID-19
Study type: Interventional

Summary: 
      A pilot study was initiated to assess feasibility of testing asymptomatic dental patients
      presenting to the Oral Medicine Clinic at Rutgers School of Dental Medicine for SARS-CoV-2
      viral antigen using a point-of-care (POC) Rapid Antigen test.

      14 subjects with upcoming appointment at the Oral Medicine clinic, Rutgers School of Dental
      Medicine, with no history of documented COVID-19 infection or viral exposure, were enrolled
      in a study that interrogated patients' perceptions of safety and feedback regarding their
      testing experience. All 14 patients expressed initial interest, however, 10 patients
      completed informed consent and completed study procedures.

      Institutional Clinical Laboratory Improvement Amendments (CLIA) certification of waiver was
      obtained prior to conducting the study. Communicable Diseases Reporting and Surveillance
      System (CDRSS) registration and training were completed to enable reporting results of the
      POC test.
    

Detailed description: 
      A pilot study was initiated to assess feasibility of testing asymptomatic dental patients
      presenting to the Oral Medicine Clinic at Rutgers School of Dental Medicine for SARS-CoV-2
      viral antigen using a point-of-care (POC) Rapid Antigen test.

      14 subjects with upcoming appointment at the Oral Medicine clinic, Rutgers School of Dental
      Medicine, with no history of documented COVID-19 infection or viral exposure, were enrolled
      in a study that interrogated patients' perceptions of safety and feedback regarding their
      testing experience. All 14 patients expressed initial interest, however, 10 patients
      completed informed consent and completed study procedures on their appointments, the
      remaining 4 patients did not present for their appointment.

      Following initial interest in participation over the phone, the subjects completed a
      pre-visit survey prior to their upcoming appointment. The day prior to their visit, a phone
      triage was completed and repeated as they checked in for their appointment. A nasal sample
      was collected and processed using the FDA EUA authorized Rapid Antigen Test BD Veritor Plus
      Analyzer, BD Sciences. An end-of-study survey was collected to assess patients' feedback
      about their experience and their perception of safety.
    

Intervention name(s): Testing for SARS CoV2 Antigen
Intervention type(s): Device
Intervention description(s): Device: Testing for SARS CoV2 Antigen Antigen testing: Rapid Antigen testing (Point-of-care)
Intervention model: Single Group Assignment
Intervention model description: Pilot study to assess feasibility of testing asymptomatic dental patients for SARS-CoV-2 antigen using Rapid Antigen point-of-care testing
Masking: None (Open Label)
Primary purpose: Other
Keywords: Screening; Point-of-care testing; Asymptomatic patients; Perception of safety; Feasibility
Brown Seaweeds Effect on Glucose Tolerance and Appetite Response
Condition: High Blood Glucose
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      The project is a randomized, 3-way, blinded crossover trial in which 20 healthy, fasted
      participants consume meals with 30 g of a linear corn starch and 5 g of one of the seaweeds,
      Laminara digitata or Undaria pinnatifida or a pea protein control. The primary aim is to
      investigate whether the brown seaweeds affect the postprandial glucose Area Under the Curve
      (AUC). Stomach emptying, insulin, C-peptide, appetite-regulating hormones (oxyntomodulin,
      glucagon, GLP-1 and PYY), and specific metabolites from the seaweeds in the urine and plasma
      as well as subjective satiety are also analyzed.
    

Detailed description: 
      Brown seaweeds may contain bioactive compounds as they contain secondary plant metabolites,
      including flavonoids and other phenolic compounds as well as carotenoids. Dietary fibre is
      the major component of brown seaweeds, mainly composed from laminarans, alginates, fucans and
      cellulose. Several dietary fibers and secondary plant metabolites have been shown to have an
      impact on health and more specifically on glycemic control. Therefore, the aim of this study
      was to investigate whether two selected brown seaweeds have an effect on the postprandial
      glucose response to a starch load as well as several secondary measures, including appetite
      responses.

      In a controlled crossover trial, 20 healthy fasted participants consumed 5 g of either
      Laminaria digitata (LD) or Undaria pinnatifida (UP) or 1 g of pea protein (CTR). The
      volunteers concomitantly ingested 200 mL of a drink with corn starch. Blood samples were
      drawn at baseline, as well as 20, 40, 60, 90, 120 and 180 min after the meal. Differences in
      glucose, insulin, C-peptide, plasma incretin concentrations, and insulin sensitivity index
      (ISI) were analyzed and appetite was scored by a visual analogue scale and a subsequent ad
      libitum test meal.
    

Intervention name(s): LD; UP; CTR
Intervention type(s): Other; Other; Other
Intervention description(s): Participants ingested 5 g of Laminaria digitata followed by 30 g of corn starch mixed with 200 mL of water.; Participants ingested 5 g of Undaria pinnatifida followed by 30 g of corn starch mixed with 200 mL of water.; Participants ingested 30 g of corn starch and 1 g of pea protein powder mixed with 200 mL of water.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Seaweed; Insulin; Glucose tolerance; C-peptide; Appetide; Metabolomics
Bilateral Bispectral Index (BIS)-Monitoring in Trauma Surgery
Condition: Knee Replacement Surgery
Study type: Observational

Summary: 
      The principal objective is to notice the relevance of timing performance of femoral block for
      knee replacement surgery during general anesthesia and analyze the relationship with
      bilateral bispectral index (BIS) monitoring during induction and maintenance of anesthesia.
      Otherwise the investigators try to investigate if the timing of performance of this block
      influence in postoperative variables as pain or blood loss.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ASA physical status I-III patients scheduled for total knee arthoplasty
      
Keywords: Trauma patients
Young Adult Cardiovascular Health sTudy
Condition: Preterm Birth; Hypertension
MeSH terms: Premature Birth; Hypertension
Study type: Observational

Summary: 
      The purpose of this study is to understand more about why young people who were born
      prematurely may have increased risk of high blood pressure and lower cardiovascular exercise
      capacity.
    

Detailed description: 
      Young adults with a history of preterm birth are identified as having a unique risk profile
      for developing hypertension and having reduced exercise capacity. Globally, there are 15
      million annual preterm births. In Europe, incidence is 6-15% of all births, with up to 6
      million adults in the United Kingdom having a preterm birth history. Understanding the
      associations between early life exposures and this early cardiovascular risk is extremely
      important to be able to target primary prevention strategies.

      As yet there are no clear explanations for the reduced exercise capacity and elevated risk of
      hypertension reported in preterm born young adults. Magnetic resonance imaging studies of
      young adult born premature demonstrated altered heart shape, with increased left ventricular
      mass, reduced cavity sizes and reduced stroke volumes. The changes in cardiac size identified
      from these studies is similar to those seen in other disease groups and has been equated to
      greater than 50% increased risk of cardiovascular clinical events in these groups. These
      structural changes may account for the reduced exercise capacity observed in preterm born
      young adults

      This study aims to understand the physiological determinants of limited exercise capacity and
      associated cardiovascular risk profile of adult preterm born populations.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults aged between 18 and 40 years old, recruited from the local community and Oxford
        University Hospitals Hypertension clinic, participants will have a history of preterm (<37
        weeks) or full term (>37 weeks) birth.
      
Biospecimen description: 
      Whole blood, serum, plasma
    
Keywords: Preterm birth; Hypertension; Exercise capacity; Cardiovascular risk
An Open-label, Randomized, Prospective Study of the Effectiveness, Safety, and Clinical Outcomes of Stapled Anastomoses Versus Hand-Sutured Anastomoses in Patients Undergoing Gastrointestinal End to End or Side to Side Anastomoses
Condition: Gastrointestinal Disease; Colorectal Disease
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional

Summary: 
      This study is being conducted to compare surgical and patient outcomes across stapled (Group
      II) versus hand-sutured (Group I) groups.
    


Intervention name(s): Advant 55 Linear Cutter/Stapler; Suturing
Intervention type(s): Procedure; Procedure
Intervention description(s): Advant 55 Linear Cutter/Stapler; Suturing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Stapling; hand sutured anastamosis; colorectal disease
A Study To Compare Emotional Changes In Subjects With Social Anxiety Disorder
Condition: Social Phobia
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare by neuroimaging techniques the way Social Anxiety patients respond to public
      speaking before and after a drug administration
    


Intervention name(s): Placebo treatment during 8 weeks; Paroxetine treatment during 8 weeks
Intervention type(s): Drug; Drug
Intervention description(s): comparator; treatment drug
Other intervention name(s): Placebo treatment during 8 weeks
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PET; Social Anxiety Disorder; fRMI
Study to Compare Milk Protein Isolate (MPI) With Caseinate in Terms of Protein Utilization
Condition: Enteral Feeds
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The Clinical Research Ethics Committee, Cork comprises of faculty representatives, external
      representatives, legal representatives and appropriate individuals and ex-officio
      administrative members with needed expertise. Ethics Committee members, including the Chair,
      are appointed by the Head of College, University College Cork, Medical School.

      The Ethics Committee meets once a month.
    


Intervention name(s): Caseinate; Milk Protein Isolate
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The test meal is a vanilla flavoured enteral drink, containing 1.5kcal/ml, 21% CHO, 6% protein and 5% fat. The 6% protein in this test meal is Caseinate; The test meal is a vanilla flavoured enteral drink, containing 1.5kcal/ml, 21% CHO, 6% protein and 5% fat. The 6% protein in this test meal is Milk Protein Isolate.
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
To Assess the Photosensitisation and Photoallergy Potential of a Cosmetic Facial Product in Healthy Participants
Condition: Skin Care
MeSH terms: Dermatitis, Photoallergic; Photosensitivity Disorders
Study type: Interventional

Summary: 
      To evaluate the skin irritation and sensitization potential of a cosmetic facial product,
      under exaggerated conditions of use with controlled product application and under supervision
      of a dermatologist.
    

Detailed description: 
      In this three-phase phototoxicity-photosensitisation (PT-PA) study, the test material and a
      positive control are applied under a semi-occlusive patch to the upper back of each subject.
      The first phase of the study is an Induction Phase; a controlled amount of each product is
      applied under a semi-occlusive patch. The patch will remain on the skin for 24 (±2) hours
      during this phase. Following patch removal the patch site will be exposed to ultraviolet - A
      (UVA) radiation and re-assessed 24 hours later prior to re-application of another
      semi-occlusive patch (with both the products) to the same site. The Induction phase will last
      3 weeks. After a subject completes the Induction Phase they will enter a Rest Phase of 2
      weeks duration, during which no patches will be applied. After the Rest Phase, subjects will
      return to the clinical site for the Challenge Phase. In the Challenge phase two test patches
      will be applied to virgin skin areas on each subjects' upper back for 24 hours. Following
      removal of both patches, one of the Challenge patch test sites will be exposed to UVA
      radiation. Both Challenge patch test sites will be assessed up until 72 (±2) hours later.
    

Intervention name(s): Facial micellar cleanser; Saline Solution: Sodium Chloride (NaCl; 0.9%)
Intervention type(s): Other; Other
Intervention description(s): Each participant will have the test product applied topically via semi occlusive patch, on-site by a technician.; Each participant will have the reference product applied topically via semi occlusive patch, on-site by a technician.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Multicenter Endoscopic Sleeve Gastrectomy (ESG) Trial (MERIT Trial)
Condition: Obesity; Hypertension; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Endoscopic Sleeve Gastroplasty (ESG) is an endoscopic minimally invasive weight loss
      procedure where a commercially available, FDA approved, full-thickness endoscopic suturing
      device (Overstitch; Apollo Endosurgery, Austin, TX) is used to reduce the stomach volume by
      80% through the creation of a restrictive endoscopic sleeve. This is accomplished by a series
      of endoscopically placed full-thickness sutures through the gastric wall, extending from the
      antrum to the gastroesophageal junction.

      Up to 200 participants at 9 locations in the United States will participate in this study.

      The ESG procedure has been performed clinically since 2013 in the United States. The
      investigators are completing this study to compare how effective the ESG is for achieving
      long-term weight loss when compared to lifestyle modification only, as well as to evaluate
      the long-term safety and durability of the procedure and its impact on quality of life.
      Results of this research may help support having this procedure covered by health insurance
      plans for future patients.
    


Intervention name(s): Overstitch Endoscopic Suture System; Lifestyle Intervention
Intervention type(s): Device; Behavioral
Intervention description(s): Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall.; Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Acute Effects of Exercise on the Cortical Silent Period in Prostate Cancer Patients
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      In Canadian men, prostate cancer (PCa) is the most prevalent form of cancer and the third
      leading cause of cancer-related death. Unfortunately, PCa survivors are often burdened with
      feelings of anxiety and depression associated with the disease and associated treatments.
      Short-term exercise interventions (8-24 weeks) have improved psychosocial well-being in this
      population, but the impact of single bouts of exercise and related psychological or
      neurological changes have never been studied. The primary objective of the proposed study is
      to examine the effect of an acute bout of exercise on neurophysiological and psychological
      indicators of well-being in a randomized controlled trial (RCT) of 36 men with PCa.
      Participants will be randomly assigned to the intervention (60 min exercise) or control (60
      min of television) and will undergo a brief neurological test (cortical silent period) and
      psychological questionnaires before and after their group assignment.
    


Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): 1 hour of moderate-intensity exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Prostate Cancer; Exercise; Cortical Inhibition; Cortical Silent Period; Transcranial Magnetic Stimulation
Video-assisted Umbilical Fascial Closure in Laparoscopic Cholecystectomy
Condition: Cholelithiasis (Without Cholecystitis); Pain, Postoperative; Hernia Incisional
MeSH terms: Cholecystitis; Cholelithiasis; Cholecystolithiasis; Gallstones; Hernia; Pain, Postoperative; Incisional Hernia
Study type: Interventional

Summary: 
      A prospective randomized study was performed including consecutive patients who underwent an
      elective laparoscopic cholecystectomy (LC) for symptomatic cholelithiasis during the 18
      months period. This prospective randomized trial aims to compare two umbilical closure
      techniques for trocar site hernia (TSH) in laparoscopic cholecystectomy.
    

Detailed description: 
      Laparoscopic cholecystectomy (LC) is currently the gold standard in the treatment for
      symptomatic cholelithiasis that offers a variety of advantages over conventional open surgery
      such as shorter recovery time, better cosmesis, less wound complication rates, and less pain
      (1,2). Despite these advantages, LC can result in unique complications. Among these
      complications, trocar site hernia (TSH) is one of the most important complications because
      laparoscopic cholecystectomy promises smaller abdominal incisions and better cosmetic
      outcomes. A second surgical intervention due to TSH may overshadow the gains of the previous
      laparoscopic surgery. In studies conducted to date, the rate of trocar hernia in laparoscopic
      cholecystectomy has been presented at very different rates. Many studies have shown that the
      most frequent site of TSH is the umbilical trocar site (3-6).

      To avoid this important complication of laparoscopic cholecystectomy, many different
      techniques have been described to date for trocar port fascia repair (7-12). Most of these
      techniques require special devices. In addition, a few studies compare these techniques with
      standard fascial closure, which is mostly used by surgeons (11,12).

      We hypothesized that the fascial closure of the umbilical trocar incision under the
      intra-abdominal vision with the laparoscopic camera could be reduced TSH. This prospective
      randomized controlled study aims to assess whether fascial closure of umbilical trocar site
      under direct laparoscopic vision in LC can reduce the incidence of TSH.
    

Intervention name(s): video-assisted umbilical closure
Intervention type(s): Procedure
Intervention description(s): video-assisted umbilical closure
Other intervention name(s): standard umbilical fascial closure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: laparoscopic cholecystectomy; pain; trocar site hernia
Assessing the Psychosocial Burden in Women With an Abnormal Pap Results After Screening Interventions
Condition: Papanicolaou Smear
Study type: Observational

Summary: 
      The primary purpose of this study is to assess the psychosocial burden in women who have
      experienced an abnormal pap results after screening interventions.
    

Detailed description: 
      This study will be a Thailand, clinic-based, cross-sectional, questionnaire study.
      Approximately 151 female participants will be enrolled. Study staff will interview the
      subject to collect basis demographic data and self reported medical history. And the subjects
      will be given the questionnaire packet for self-administration. After subjects complete the
      packet, study staff will review the questionnaires for completeness prior to the study
      subject leaving the clinic.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients having pap-smear at Ratchawithi Hospital