bioihbjkbjnl/mcl2 huggingface dataset:
Nutritional Metabolomics: the Search for Dietary Exposure Variables 2
Condition: Healthy
Study type: Observational

Summary: 
      In the post-genomic era, a major challenge for health research is to understand the complex
      interactions among genetic, environmental and lifestyle factors including dietary intake.
      Unfortunately, such initiatives are hampered by the lack of accurate dietary intake
      assessment methods for large studies. The newly emerging field of metabolomics offers unique
      possibilities to characterize individual food intake, dietary patterns and effects of dietary
      intervention in large studies. The investigators propose to develop a platform to detect
      broad metabolomic responses to food intake in controlled trials as well as to use targeted
      metabolomics approaches to characterize dietary intake in longitudinal studies. Our
      laboratory has a long history of developing methodology for assessing nutritional status and
      effects of diet on metabolism. Here, the investigators team up with the Sahlgrenska Academy
      Core Facility and the Swedish NMR Centre at the University of Gothenburg, that offer modern
      metabolomics equipment and competence in bioinformatics, and use this in the context of
      nutrition research. To their knowledge, the investigators are among the first groups in the
      country to develop skills in metabolomics to assess dietary intake and effects of nutrition
      on metabolism, and probably the first to use two complementary platforms with both
      mass-spectrometry and nuclear magnetic spectroscopy. Hence, our methodological results should
      be useful to nutritional scientists nationally as well as internationally.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy subjects Adults
      
Biospecimen description: 
      Whole blood
    
Keywords: vegetarian; vegan; omnivore; Habitual diet
The Effect of Pneumoperitoneum and Trendelenburg Position on Intracranial Pressure: Ultrasonographic Measurement of Optic Nerve Sheath Diameter
Condition: Robot-assisted Laparoscopic Prostatectomy Under General Anesthesia
Study type: Observational

Summary: 
      The steep Trendelenburg position and pneumoperitoneum during laparoscopic surgery have the
      potential to cause an increase of intracranial pressure (ICP). Previous studies have proposed
      that ultrasonographic measurements of the optic nerve sheath diameter (ONSD) correlate with
      signs of increased ICP. Therefore, this study is aim to confirm the increased ICP by
      ultrasonographic measurement of ONSD during laparoscopic surgery.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing robot-assisted laparoscopic prostatectomy under general anesthesia
A Comparative Study on Three Different Doses of Intrathecal Hyperbaric Prilocaine With Fentanyl for Optimal Dose to be Used in Elderly Patients Undergoing Day Case Lower Abdominal and Urologic Surgeries.
Condition: Three Different Doses of Intrathecal Hyperbaric Prilocaine With Fentanyl
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the effects of using different doses of intrathecal hyperbaric prilocaine 2%
      combined with fentanyl 25 µg in patients scheduled for a day-case lower abdominal and
      urologic surgery in the geriatric patient population.
    

Detailed description: 
      -  To evaluate the safety and effectiveness of spinal anaesthesia with hyperbaric
           Prilocaine 2% in a reduced dose (30mg) in combination with Fentanyl (25µg) in day-case
           lower abdominal and urologic surgeries in the geriatric population.

        -  To compare between three different doses of prilocaine 2% in elderly patients undergoing
           day case lower abdominal and urologic surgeries.

        -  To estimate the duration of stay in PACU and hospital stay with different doses of
           prilocaine 2% in elderly patients undergoing day case lower abdominal and urologic
           surgeries.
    

Intervention name(s): Pilocaine 2% (1.5 ml) and 25 ug fentany
Intervention type(s): Drug
Intervention description(s): Patients will be randomly allocated into the study groups according to the list of random numbers. The study groups will be as follows:
Group P1 (N 15): patients assigned to this group will receive intrathecal 30 mg (1.5 ml) of prilocaine 2% (Takipril, prilocaine hydrochloride 20 mg/mL, hyperbar, Sintetica) + 25 ug fentanyl (0.5 ml).
Group P2 (N 15): patient assigned to this group will receive intrathecal 40 mg (2 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml).
Group P3 (N 15): patient assigned to this group will receive intrathecal 50 mg (2.5 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml).
Other intervention name(s): Pilocaine 2%(2 ml) and 25 ug fentany; Pilocaine 2%(2.5 ml) and 25 ug fentany
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The purpose of this study is to determine the least sufficient dose of intrathecal hyperbaric prilocaine 2% combined with fentanyl 25 µg required for day-case lower abdominal and urologic surgeries , fewer adverse effects, faster recovery time, and shorter stay in post anesthesia care unit (PACU) in the geriatric patient population, as a previous study has investigated hyperbaric prilocaine (30 mg) when combined with fentanyl (20 µg) for a day-case perianal surgery, achieving a spinal anaesthesia with a mean sensory level of T9
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Dental Implant Care and Oral Hygiene Practices
Condition: Peri-implant Mucositis; Peri-Implantitis; Dental Plaque
MeSH terms: Mucositis; Peri-Implantitis; Dental Plaque
Study type: Observational

Summary: 
      Objective: This study investigated how patients' knowledge, attitude, and perceptions
      influence their oral hygiene practices as well as peri-implant health. Materials and Methods:
      Participants with single implant crowns placed in 2007-2011 completed a questionnaire that
      examined their knowledge, attitude, and perceptions on oral hygiene practices and
      peri-implant health before receiving a periodontal examination, prophylaxis, and oral hygiene
      education. Clinical parameters recorded were peri-implant probing depths and plaque index,
      width of keratinized mucosa, implant crown characteristics, reason for tooth loss, and
      diagnosis of peri-implant health.
    

Detailed description: 
      First, a trained clinical research dental assistant interviewed the participants and showed
      them pictures of oral hygiene aids so that the participants could answer the survey questions
      accurately. Subsequently, a periodontal examination, dental prophylaxis, and oral hygiene
      education were performed. Participants with active diseases e.g. caries, periodontitis, or
      peri-implantitis were referred for further management. The following clinical parameters were
      recorded during the examination:

        1. Probing depths at 6 sites around the implant (mesiobuccal, midbuccal, distobuccal,
           distolingual, midlingual and mesiolingual)

        2. Plaque index (Silness & Loe 1964) at 4 sites around the implant (mesial, buccal, distal
           and lingual)

        3. Amount of keratinized mucosa at the implant site

        4. Characteristics of the implant crown:

             -  Type of implant crown (screw- or cement-retained) and

             -  Position of crown margins (supra-, equi- or sub-gingival)

        5. Reason(s) for tooth loss

        6. Diagnosis of peri-implant health

             -  Normal

             -  Mucositis, defined as 3 or more bleeding points per implant

             -  Peri-implantitis, defined as implant thread exposure that was either clinically
                visible or detectable with a periodontal probe.
    

Intervention name(s): non-surgical periodontal treatment
Intervention type(s): Procedure
Intervention description(s): scaling, root planing, polishing, and oral hygiene education was performed
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Study population is made up 50.6% male and 49.4% female, mainly Chinese (87.3%), Indian
        (5%), Malay (3.8%), Caucasian (1.3%), Eurasian (1.3%), and Japanese (1.3%), with a mean age
        of 58.6 years old.
      
Keywords: Dental devices; Home care; Awareness; Peri-implant mucositis; Peri-implantitis
Dynamic Changes of Tim-3 on Monocytes and Soluble Tim-3 in Patients With Sepsis
Condition: Sepsis; Severe Sepsis; Septic Shock
MeSH terms: Sepsis; Toxemia
Study type: Observational [Patient Registry]

Summary: 
      In this study, the investigators will dynamically detect the expression of an immune
      regulator- T cell Ig and mucin domain protein 3 (Tim-3) in patient with sepsis.
    

Detailed description: 
      In this study, we will collect the peripheral blood of 1,3,5,7,10,14 day after diagnose of
      sepsis.All the patients rolled in this study will be divided into three groups which is
      sepsis, severe sepsis and septic shock group according their severity. Then,the flow
      cytometry will be used to detect the express of Tim-3 on monocyte and ELISA will be used to
      exam the plasm soluble Tim-3.IL-6,IL-10,IL-12 and TNF-αin the peripheral blood will also be
      detected. We would like to find a new marker to predict the severity and prognosis of sepsis
      patients.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with sepsis
      
Biospecimen description: 
      peripheral blood
Acupuncture for Fatigue in Parkinson's Disease
Condition: Parkinsons Disease
MeSH terms: Parkinson Disease; Fatigue
Study type: Interventional

Summary: 
      This is a single-center, double-blind, placebo-controlled trial to see if acupuncture can
      safety and effectively treat fatigue in Parkinson's Disease (PD). Eligible subjects will
      receive either real or sham acupuncture twice weekly for six weeks.
    


Intervention name(s): Acupuncture; Acupuncture to treat fatigue in Parkinson disease
Intervention type(s): Procedure; Other
Intervention description(s): Subjects will be randomized in a 1:1 ratio to receive real acupuncture. Acupuncture is a procedure in which specific body areas are pierced with fine needles for therapeutic purposes; Subjects will be randomized in a 1:1 ratio to receive sham acupuncture.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinsons Disease; Fatigue
SGLT2 Inhibitor Effects on Inflammation and Heart Disease in Obesity Pilot
Condition: Obesity; Pre-diabetes
MeSH terms: Obesity; Prediabetic State; Inflammation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Obesity is associated with increased cardiometabolic disease risk due, in part, to heightened
      chronic inflammation arising from adipose tissue. There are no current targeted therapies to
      prevent or reverse the chronic inflammation of obesity, and a better understanding of these
      inflammatory pathways in humans is key to future therapeutic interventions. This project will
      determine both the anti-inflammatory potential of the SGLT2 inhibitor empagliflozin, and the
      contribution of adipose inflammation to surrogate measures of cardiovascular disease in a
      randomized controlled trial of obese patients.
    

Detailed description: 
      This study will be expanded to include another 10 participants. Enrollment will begin July 1,
      2023.
    

Intervention name(s): Empagliflozin 25 MG
Intervention type(s): Drug
Intervention description(s): Oral empagliflozin daily
Intervention MeSH terms: Empagliflozin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Neuromodulation in Lateral Elbow Pain
Condition: Lateral Epicondylitis
MeSH terms: Tennis Elbow
Study type: Interventional

Summary: 
      Lateral epicondylitis (LE), also known as tennis elbow, refers to a painful condition at or
      around the lateral epicondyle of the humerus and common extensor tendon (CET) that is
      aggravated by dorsiflexion and/or supination of the wrist against resistance. Lateral
      epicondylitis is one of the most common injuries of the elbow, affecting 1-3% of the
      population.

      Therefore, determining an effective intervention that helps manage the condition and lessens
      the financial burden is important. Passive physical modalities, including electrotherapy and
      orthotic devices, are common treatments for the management of elbow pain. Passive physical
      modalities are physical treatments involving a device that does not require active
      participation by the patient. In a systematic review, 2017, Dion et al examined the
      effectiveness of passive physical modalities for the treatment of soft tissue injuries of the
      elbow, but little evidence exists to support or refute their use.

      Clinically, an invasive technique has appeared, known as Ultrasound-guided Percutaneous
      Neuromodulation (PNM). This minimally invasive intervention consists in the applicacion of a
      percutaneous electrical stimulation (PES) through an acupuncture needle-like electrode that
      is placed in close proximity to the nerve or motor point of the muscle with ultrasound
      guidance. At the clinical level, the PES is always used with the therapeutic aim of relieving
      chronic pain and neuropathic pain. Similarly, in sports, PES is used with the aim of
      improving muscular activity. Therefore, according to the characteristics and the therapeutic
      benefits of this technique, further research is needed to discover multiple clinical
      indications.

      The aim of this pilot study was to examine the effects of a percutaneous neuromodulation
      intervention in patients with unilateral refractory lateral epicondylitis. Findings from this
      study may provide further evidence for the relevance of neural tissues in determining the
      elbow pain and may indicate effects of US-guided NMP technique on the rehabilitation and/or
      prevention of in patients with unilateral refractory LE.
    


Intervention name(s): Ultrasound-guided Percutaneous Neuromodulation
Intervention type(s): Other
Intervention description(s): It's a new intervention of sport physiotherapy. It´s an invasive technique. It is necessary an ultrasound
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Percutaneous Neuromodulation, radial nerve, pain
The Acute Effects of Chamomile Intake on Blood Coagulation Tests in Healthy Volunteers
Condition: Coagulation Disorder
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders
Study type: Interventional

Summary: 
      Chamomile may possess anticoagulant effects based on the presence of coumarin-like compounds
      within the flower. This randomized complete crossover study will investigate the impact of
      chamomile ingestion acutely on coagulation.
    

Detailed description: 
      Subjects will be enrolled into two groups in a crossover fashion upon obtaining written
      informed consent. The two intervention groups include (1) chamomile tea intake and (2)
      chamomile extract intake. Subjects will consume a single preparation of chamomile tea or
      extract capsule, and partake in a minimum of three days washout period between interventions.
      Screening assays of coagulation will be obtained immediately before the ingestion of
      chamomile, two hours after ingestion, and four hours after ingestion over the course of a
      single day.
    

Intervention name(s): Chamomile Tea; Chamomile Extract Capsule
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Chamomile tea bags consumed by subjects as described in study arms section.; Chamomile extract capsules consumed by subjects as described in "Experimental: Chamomile Extract Capsule" study arms section.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Our study is a crossover trial with subjects randomized to one of two treatment sequences: (A) a single dose of chamomile extract capsule followed by a single dose of chamomile tea or (B) a single dose of chamomile tea followed by a single dose of chamomile extract capsule. The study requires two visit days where subjects will consume their assigned chamomile preparation at the research site. To minimize any carryover effects, the two visits must be at least 3 days apart, and no more than 8 weeks apart. Randomization will be computer-generated by the biostatistician using the SAS software, and implemented using REDCap software
Masking: Single (Investigator)
Primary purpose: Screening
Keywords: Coagulation; Chamomile
Umbilical Cord Blood Transplant for Hematological Malignancies
Condition: CML; AML; MDS; ALL; NHL; Multiple Myeloma; Hodgkin's Disease
MeSH terms: Multiple Myeloma; Hodgkin Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This protocol will enroll subjects with advanced hematologic malignancies who do not have a
      suitable related or unrelated donor to undergo a Stem Cell Transplant.

      In this study, subjects will undergo a Stem Cell Transplant using Cord Blood. Part of the
      cord blood will be used for the Stem Cell Transplant and part of the cord blood will be sent
      to a laboratory in order to grow the T cells (from the cord blood) and increase the activity
      of the cord blood T cells.

      The purpose of this part of the study is to see if it is safe to give study subjects
      activated T cells made from a small portion of their donor UCB unit immediately after the UCB
      transplant. Activated T cells have been used safely in stem cell transplantation studies in
      the past, but they have never been studied UCB transplantation.
    

Detailed description: 
      The main study intervention includes CD3/CD28 ex vivo costimulated T cells derived from a
      thawed umbilical cord blood unit, co-infused following a myeloablative conditioning regimen.

      Activated T cells are T cells that have been activated in the laboratory by exposure to 2
      compounds or molecules called CD3 and CD28; when T cells are exposed to both of these
      compounds at the same time, they become activated or "stimulated" and may be more effective
      in fighting infections, cancer cells, and promoting the recovery of red cells, white cells,
      and platelets after transplantation. At the Hospital of the University of Pennsylvania,
      activated T cells are prepared at the Clinical Cell and Vaccine Production Facility, also
      known as the CVPF.
    

Intervention name(s): Ex Vivo CD3/CD28 costimulated Umbilical Cord Blood T cells; Observation Arm
Intervention type(s): Biological; Other
Intervention description(s): Single infusion of Cord Blood Cells AND Single Infusion of ex vivo CD3/CD28 costimulated Umbilical Cord Blood T cells.
Table 6: Dose escalation (Dose level CD3+ cell dose)
1xE5 cells/kg
2xE6 cells/kg
3xE7 cells/kg
4xE8 cells/kg; Single infusion of Cord Blood Cells
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AML; MDS; ALL; NHL; Multiple Myeloma; Hodgkin's
Effect of Thoracic Block Technique on Atelectasis in Children on Mechanical Ventilation
Condition: Atelectasis; Intensive Care Unit; Children
MeSH terms: Pulmonary Atelectasis
Study type: Interventional

Summary: 
      Statement of the problem:

      • Does the thoracic block technique has effect on atelectasis in Children on Mechanical
      Ventilation?

      Null hypothesis:

      • there is effect of thoracic block technique on atelectasis in children on Mechanical
      ventilation.
    

Detailed description: 
      Subjects:

      The study targets the children from both sexes. Sample size estimation will be carried out to
      determine the recruited number of children, selected randomly from Cairo University pediatric
      specialized hospital intensive care units ,Cairo to participate in the study

      Study design:

      Randomized controlled clinical trial.

      A. Inclusion criteria:

        1. age range from 6 months to 4 years .

        2. diagnosed with pneumonia, receiving Mechanical ventilation.

        3. start from second day of admission to intensive care unit.

        4. have unilateral mild to moderate atelectasis according to medical referral .

        5. should be vitally stable during the session.

      B. Exclusion criteria:

      The children will be excluded from the study if they had one of the following:

        1. medically unstable ( examples: tachycardia and tachypnea).

        2. uncontrolled convulsion.

        3. irritable or moderate to sever pain

        4. rib fracture

        5. pneumothorax

      Children will be assessed by measuring heart rate, respiratory rate, chest x-ray, arterial
      blood gases,dynamic compliance, oxygen saturation index before and after ten days of
      receiving intervention
    

Intervention name(s): Thoracic block technique; Designed chest physical therapy program
Intervention type(s): Other; Other
Intervention description(s): Manual compression of the healthy lung during expiration associated with the use of invasive or non invasive mechanical ventilation; Percussion, vibration and postural drainage
Other intervention name(s): Technique of insufflation to reverse atelectasis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Phase I/II Study of High-Dose Acyclovir for Central Nervous System or Disseminated Neonatal Herpes Simplex Virus Infection
Condition: Herpes Simplex
MeSH terms: Herpes Simplex
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      OBJECTIVES: I. Evaluate whether high-dose acyclovir decreases acute and long-term morbidity
      and mortality in neonates with central nervous system or disseminated herpes simplex virus
      (HSV) infection.

      II. Evaluate whether high-dose acyclovir is safe and tolerated in the newborn. III. Assess
      resistance to antiviral medication. IV. Amplify disease classification for the purpose of
      predicting prognosis. V. Assess any changes in viral excretion patterns. VI. Evaluate whether
      antigens and antibodies specific for HSV glycoproteins within the cerebrospinal fluid (CSF)
      predict long-term neurologic outcome.

      VII. Evaluate whether specific antigens and antibodies in the CSF appear late after treatment
      and are indicative of insidious reactivation of virus in the brain.
    

Detailed description: 
      PROTOCOL OUTLINE:

      Neonates are treated with intravenous acyclovir for 21 days. Patients are followed at day 28,
      and at 6, 12, 24, 36, and 48 months.
    

Intervention name(s): acyclovir
Intervention type(s): Drug
Intervention MeSH terms: Acyclovir
Primary purpose: Treatment
Keywords: herpes simplex virus infection; herpesvirus infection; immunologic disorders and infectious disorders; rare disease; viral infection