bioihbjkbjnl/mcl2 huggingface dataset:
FreeStyle LIbre Flash Glucose Monitoring System Pediatric Accuracy Study
Condition: Diabetes Mellitus
Study type: Observational

Summary: 
      The purpose of this study is to characterize the Freestyle Libre Flash Glucose Monitoring
      System in pediatric subjects with respect to YSI reference venous plasma sample measurements.
    

Detailed description: 
      Up to 250 subjects will be enrolled at up to six (6) clinical research sites in the United
      States. Subjects will wear two Sensors. Each Sensor will have a paired Reader that will be
      given to the subject. All Readers will be masked during the study (i.e. subjects will not be
      able to view glucose results obtained from the Sensor on the Reader screen). Subjects will be
      asked to perform at least 4 capillary Blood Glucose (BG) tests per day using the primary
      Reader. Interstitial glucose readings from each Sensor will be obtained with the
      corresponding Readers immediately following each BG test. Subjects will be instructed to
      report any problems with the device. Subjects will make three (3), four (4) or five (5)
      scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit
      1). Based on the subjects weight, subjects will have up to two (2) in-clinic visits during
      which intravenous blood draws and YSI reference testing will occur.
    

Intervention name(s): Freestyle LIbre Flash Glucose Monitoring System
Intervention type(s): Device
Intervention description(s): System Performance will be characterized with respect to YSI reference venous plasma measurements
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric subjects aged 4-17 with Type 1 or Type 2 diabetes.
Awareness of Osteoporosis in Multiple Sclerosis Patients
Condition: Multiple Sclerosis; Osteoporosis; Osteoporosis Risk
MeSH terms: Osteoporosis; Multiple Sclerosis; Sclerosis
Study type: Observational [Patient Registry]

Summary: 
      Osteoporosis is a condition that describes compromised skeletal microarchitecture in general,
      with clinical signs of decreased bone mineral density. Multiple sclerosis patients are at
      increased risk for developing osteoporosis. Identifying whether multiple sclerosis patients
      have information and awareness about this disease is crucial. This study is aimed to
      investigate awareness and knowledge of osteoporosis in multiple sclerosis patients.
    

Detailed description: 
      Osteoporosis is a common disease of bone loss. The reduced bone strength predisposes an
      increased risk for fractures in older individuals. It can affect people from different
      ethnicity. Many factors increase the risk of osteoporosis, including age, postmenopausal
      state, glucocorticoid use, low body weight, calcium, vitamin D, immobility, and chronic
      inflammation. Patients with multiple sclerosis are at high risk of developing osteoporosis
      due to chronic inflammation and their medications. Patients' knowledge and awareness about
      osteoporosis are essential for early detection, implementation of lifestyle changes, and
      treatment compliance. This study aimed to investigate osteoporosis awareness and knowledge
      about osteoporosis in patients with multiple sclerosis.
    

Intervention name(s): Patient Participation Form
Intervention type(s): Other
Intervention description(s): A form that consists of revised osteoporosis knowledge test, osteoporosis self-efficacy scale, and osteoporosis health belief scale.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients aged 18 to 90 years with a diagnosis of multiple sclerosis who gave consent to
        participate in the study
Blackberry Intake and Biomarkers of Cancer Risk
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      Berry components have been shown to influence cancer processes in cell culture studies. The
      investigators will conduct a study to investigate if blackberries influence the same cancer
      processes in a human feeding study.
    


Intervention name(s): Blackberries; Gelatin
Intervention type(s): Other; Other
Intervention description(s): 300 g blackberries daily for 5 days; 300 g gelatin per day for 5 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Avenanthramide and Saponin Bioavailability in Oat Bran
Condition: Human Health; Polyphenols; Pharmacokinetics
Study type: Interventional

Summary: 
      Avenanthramides and saponins are types of chemical compounds found naturally in oats.

      Avenanthramides have anti-oxidant properties, anti-atherosclerotic, anti-inflammation, and
      anti-proliferative effects on cancer cells in vitro. Oat saponins, or avenacosides, have the
      ability to bind cholesterol, and thus, the ability to lower blood cholesterol.

      Oat bran is a known source of these dietary compounds. This study aims to determine the
      bioavailability of these compounds to in the urine of participants after ingesting an oat
      bran cereal, both before, and after for multiple time points.

      Analytical chemistry will be used to determine the bioavailability of the oat compounds at
      each time point. This will help to establish a kinetic curve for the metabolism of these
      compounds.
    

Detailed description: 
      Initially, the diet of the participants will be asked to restricted to avoid eating any
      polyphenols that might interfere with the employed analytical chemistry techniques. This
      period of diet restriction is the washout period. The list of foods to avoid are: oats, whole
      grains, fruits, vegetables, herbal supplements, ginger, coffee, tea, and chocolate.

      After the washout period, a baseline urine and fecal sample will be collected from the
      participants, then a large portion of oat bran will be provided to the participants for
      consumption. The approximate portion size will be 100 g by dry weight. The participants will
      then provide urine samples during the designated time points. The time points for the urine
      collection are as follows:

        1. st sample, ~ 30 min to 1 hour prior to oat consumption

        2. nd sample: 0-2 hours after oat consumption

        3. rd sample: 2-4 hours after oat consumption

        4. th sample: 4-6 hours after oat consumption

        5. th sample: 6-9 hours after oat consumption

        6. th sample: 9-12 hours after oat consumption

        7. th sample: 12-24 hours after oat consumption

        8. th sample: 24-32 hours after oat consumption

        9. th sample: 48 hours after oat consumption These samples will be analyzed in using HPLC
           and LC/MS.
    

Intervention name(s): Oat Bran Consumption
Intervention type(s): Dietary Supplement
Intervention description(s): Oat bran (120 g), single dose.
Other intervention name(s): Gut Microbiome and Oat metabolism Study
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Avenanthramides; Saponins; bioavailability; polyphenols; oat bran; pharmacokinetics
Scintigraphy Study to Compare the Antireflux Activity of the Z0063 Versus Gaviscon Double Action Tablets, in Healthy Adult Subjects
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      Pharmacodynamics: assessment and comparison by gamma scintigraphy of the gastric retention of
      alginate rafts (raft performance) of Z0063 to the effect of Gaviscon Double Action Tablets,
      in healthy adult subjects.

      Secondary Objective:

      Safety: assessment of the clinical safety of Z0063 versus Gaviscon Double Action tablets, in
      healthy adult subjects.
    

Detailed description: 
      The total study duration per subject is 37 days including a screening period up to 21 days, a
      wash-out period of 4-7 days and a follow-up of 4-7 days.
    

Intervention name(s): Z0063; Gaviscon
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: chewable tablets Route of administration: oral; Pharmaceutical form: chewable tablets Route of administration: oral
Intervention MeSH terms: Alginate, aluminium hydroxide, magnesium trisilicate, sodium bicarbonate drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Nasya in Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate safety and efficacy of Nasya in reducing symptoms of
      persistent allergic rhinitis when applied before allergen challenge.
    


Intervention name(s): Nasya; Saline solution
Intervention type(s): Device; Device
Intervention description(s): Thixotropic nasal spray suspension, 2 sprays in each nostril; Nasal spray, 2 sprays in each nostril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Allergic rhinitis; Allergen; Allergy; Dustmite
Epidural Catheter and Surgically Implanted Rectus Sheath Catheter in Management of Postoperative Pain
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      One hundred and twenty patients at age range from 18 to 60 undergoing laparotomy was enrolled
      in this study. Patients were randomly assigned to two groups 60 in epidural group and the
      other 60 patients in rectus catheter group. epidural catheter inserted pre induction but
      rectus sheath catheter inserted by the surgeon at the end of surgery.
    

Detailed description: 
      One hundred and twenty patients at age range from 18 to 60 undergoing laparotomy was enrolled
      in this study. Patients were randomly assigned to two groups 60 in epidural group and the
      other 60 patients in rectus catheter group. epidural catheter inserted pre induction but
      rectus sheath catheter inserted by the surgeon at the end of surgery. In both groups we
      activated with10 ml bupivacain25% before patient recovery then 10 ml bupivacain.125% each 6
      hours. If patient still in pain 1gm perflgan injected. If patient still in pain 10 mg
      nalufine for 70 kg patient injected. we will record pulse, blood pressure and visual analogue
      scale at 0,6,12,24 and 36 hours postoperative. Also Occurrence of nausea and vomiting, Time
      of return of bowel movement, Time of discharage and amount of analgesia used will be
      recorded. Results, discution will be later.
    

Intervention name(s): Epidural catheter; rectus sheath catheter
Intervention type(s): Device; Device
Intervention description(s): epidural catheter inserted pre induction; The surgeon will place one hand inside the abdomen and with the other hand inserted the Tuohy needle through the skin and fascia. The surgeon will feel when the needle tip is just superfacial to interface between the peritoneum and muscle layer and avoid penetration of inferior epigastric artery. The procedure will be repeated on the contralateral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: rectus sheath catheter, pain following laparotomys.
Endoscopic Evaluation for Predicting the Complications Related to Gastric Conduit After Esophagectomy
Condition: Esophageal Neoplasms; Constriction; Anastomotic Leak; Ischemia
MeSH terms: Esophageal Neoplasms; Ischemia; Anastomotic Leak; Constriction, Pathologic
Study type: Observational

Summary: 
      Gastric conduit ischemia or anastomotic breakdown after esophagectomy with cervical
      esophagogastrostomy often cause severe complications, such as leakage, necrotic organs, and
      strictures. Thus, the purpose of this study is the safety and efficacy of endoscopic
      evaluation about reconstructive organs after esophagectomy. The investigators evaluate
      endoscopic predictions using classifications in acute phase after esophagogastrostomy.
    

Detailed description: 
      The development and improvement of thoracoscopic esophagectomy (TE) reduced the severe
      pulmonary complication after esophagectomy. However, the postoperative complications relative
      to gastric conduit reconstruction are still common issues after esophagectomy. The ischemia
      of the proximal portion of the graft predisposes these patients to a high incidence of
      anastomotic complications after esophagectomy. Less commonly, severe graft ischemia can lead
      to transmural necrosis. Thus, early diagnosis of ischemic reaction may provide the suitable
      postoperative management and therapeutic intervention to prevent leakage, strictures and
      necrosis. Thus, the purpose of this study is the safety and efficacy of endoscopic evaluation
      about reconstructive organs after esophagectomy. The investigators evaluate endoscopic
      predictions using classifications in acute phase after esophagogastrostomy.
    

Intervention name(s): Patients after esophagectomy
Intervention type(s): Diagnostic Test
Intervention description(s): Endoscopic examinations are performed at 1 and 8 postoperative days. Endoscopic examination is added when abnormal findings are demonstrated.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergo an esophagectomy with reconstruction by a gastric pull-up for malignant or
        end-stage benign esophageal disease. The patients have a cervical esophagogastrostomy.
      
Biospecimen description: 
      dmpDNA
A Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of ABT-436 in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are to assess the safety, tolerability, pharmacodynamics and
      pharmacokinetics of multiple doses of ABT-436 in healthy adults.
    


Intervention name(s): ABT-436; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): See Arm Description for details.; See Arm Description for details.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Pharmacodynamics; Drug Safety; Phase 1 Clinical Trial
HPV Self-Test Intervention in Ohio Appalachia
Condition: Cervical Carcinoma; Human Papillomavirus Infection
MeSH terms: Papillomavirus Infections
Study type: Interventional

Summary: 
      This study will pilot test a culturally appropriate human papillomavirus (HPV) self-test
      intervention among women from Ohio Appalachia in order to determine the feasibility of HPV
      self-testing as a potential cervical cancer screening strategy. The intervention group will
      receive culturally appropriate materials and the control group will receive standard
      materials with their HPV self-test device.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To determine the feasibility of HPV self-testing as a potential cervical cancer screening
      strategy and obtain preliminary efficacy data of culturally appropriate materials on
      self-test use.

      OUTLINE:

      Participants are randomized to 1 of 2 arms.

      ARM I: Participants receive a study kit that includes culturally appropriate instructions for
      using and returning the HPV self-test device and a photo story information sheet about HPV
      and HPV self-testing. Participants are asked to complete the HPV self-test and return the
      test for HPV testing.

      ARM II: Participants receive a study kit that includes standard instructions for using and
      returning the HPV self-test device and a standard information sheet about HPV and cervical
      cancer. Participants are asked to complete the HPV self-test and return the test for HPV
      testing.

      Participants are followed up at 4 weeks for return of their HPV self-test device and then for
      2 months after notification letters are sent.
    

Intervention name(s): Disease Screening; Educational Intervention; Informational Intervention; Laboratory Biomarker Analysis; Survey Administration
Intervention type(s): Procedure; Other; Other; Other; Other
Intervention description(s): Complete HPV self-test; Receive culturally appropriate instructions for using and returning the HPV self-test device and a photo story information sheet about HPV and HPV self-testing; Receive standard instructions and information sheet; Correlative studies; Ancillary studies
Other intervention name(s): Disease Screening Procedure; Screening; Screening Intervention; Education for Intervention; Intervention, Educational
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: HPV
Congenital Heart Defects and NIRS
Condition: Heart Defects, Congenital
MeSH terms: Heart Defects, Congenital; Congenital Abnormalities
Study type: Observational

Summary: 
      Congenital Heart Defects and NIRS
    

Detailed description: 
      Brain, kidney and intestinal tissue oxygenation in newborns with congenital heart defects
      assessed by near-infrared spectroscopy.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        term newborns
      
Keywords: congenital heart defects; near-infrared spectroscopy; newborn; tissue oxygenation
Validity and Reliability of Autocad Software Assessment of JPS in PFPS
Condition: Patellofemoral Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Syndrome
Study type: Observational

Summary: 
      The overall aim of the study is to assess the reliability and validity of Autocad software to
      measure JPS in PFPS, especially:

        1. To assess the intra-tester and between day reliability of measurement of JPS using
           Autocad software.

        2. To assess the validity of these measurements against those found during an IKD.
    

Detailed description: 
      Patellofemoral pain syndrome (PFPS) is a common painful musculoskeletal condition that
      affects physically active young adults and adolescents.

      Joint position sense (JPS) is considered as a component of proprioception as it provides the
      clinician with information regarding the accuracy of movement as well as its relationship
      with movement performance and injuries. Therefore researchers use advanced instruments as 3 D
      video systems and isokinetic dynamometer. Since these instruments are less portable and
      expensive, therefore researchers used another method to evaluate JPS using high precision
      software using video analysis and markers in the joints. Unfortunately, video analysis
      requires difficult and time-consuming tasks and that this slow the evaluation process.

      Although immediate feedback could help physiotherapists and athletic trainers to monitor
      athletes and make decisions during the training session and the rehabilitation process, such
      immediacy is not available for proprioceptive tests in field situations. Autocad software is
      available and inexpensive and provides immediate feedback
    

Intervention name(s): Autocad software
Intervention type(s): Diagnostic Test
Intervention description(s): The participants will be prepared for image-capture data collection by putting four squared markers on leg and thigh.Each subject will extend his/her leg and make two angles from the resting position (90º) to the full extension, photos will be taken. The tested leg passively moved by the researcher through 20° to 60° of knee extension, the participant will be instructed to actively move that leg to the target angle and hold it in this position another photograph will be taken. The angles will be measured using the AutoCAD software. Knee JPS measurements will also be collected using an IKD by same steps
Other intervention name(s): Isokinetic system
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        thirty-eight patients(males and females) with PFPS will be recruited from the outpatient
        clinic of the faculties of Physical Therapy, Cairo University, Egypt.
      
Keywords: Patellofemoral Pain Syndrome; Autocad software; position sense; validity; reliability
Irrigation Endoscopic Decompressive Laminotomy
Condition: Lumbosacral Spinal Stenosis
MeSH terms: Spinal Stenosis
Study type: Interventional

Summary: 
      The classic laminectomy for surgical treatment of spinal stenosis has considerable morbidity
      .This is further magnified by the disease being more common in elderly with associated
      medical comorbidities and being usually global involving multiple levels.The purpose of this
      study is to present and to evaluate a new endoscopic technique named Irrigation Endoscopic
      Decompressive Laminotomy (IEDL) for lumbar spinal canal decompression.
    

Detailed description: 
      In the IEDL group,2 portals 0.5cm were used one for the endoscope and the other for
      instruments. For every additional level one portal is added. The endoscope and instruments
      are directly placed over the surface of lamina without any dissection and saline under pump
      pressure is used to open a potential working space. Unilateral laminotomy and bilateral
      decompression under endoscopic vision is performed. In the microsurgical group, bilateral
      fenestration is performed in the usual manner
    

Intervention name(s): open lumbar decompression
Intervention type(s): Procedure
Intervention description(s): A posterior midline incision is performed over the affected levels. Bilateral subperiosteal dissection of the paraspinal muscles is performed. Bilateral hemilaminotomies, foraminotomies and lateral recess decompression is performed followed by wound closure
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: irrigation endoscopic decompression; minimally invasive surgery; spinal stenosis
Study of Herbmed Plus in Ureteral Stent Discomfort
Condition: Ureteral Stent Discomfort
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the efficacy and safety of the Ayurvedic formulation
      ,Herbmed Plus against placebo and anti-cholinergic drugs in relieving the ureteral stent
      discomfort.
    

Detailed description: 
      -  To evaluate the tolerability of ayurvedic preparation, Herbmed Plus in management of
           ureteral stent discomfort

        -  To know whether the ayurvedic preparation Herbmed Plus ,can reduce the requirement of
           analgesics or not

        -  To know whether the ayurvedic preparation ,Herbmed Plus can replace the use of
           analgesics/ anti cholinergics in relieving ureteral stent discomfort ?
    

Intervention name(s): Herbmed plus; Placebo; Tolterodine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): one capsule of herbmed plus orally twice a day with meals till the ureteral stent is in situ.; One capsule twice a day daily till ureteral stent in situ; One capsule twice a day daily till ureteral stent in situ
Other intervention name(s): sugar pills manufactured to mimic Herbmed plus; Torq SR; Terol LA
Intervention MeSH terms: Tolterodine Tartrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Stent discomfort; Herbmed plus; Tolterodine