bioihbjkbjnl/mcl2 huggingface dataset:
Determinants of Vitamin K Metabolism
Condition: Aging; Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      The purpose of this study is to learn how the body responds to different amounts of vitamin K
      in the diet in order to understand the roles that vitamin K may have in the body. We also
      need to determine if older adults need more or less vitamin K in their diet compared to
      younger adults in order to maintain normal body stores of vitamin K.
    

Detailed description: 
      Vitamin K has a role in bone health, but little is known about vitamin K metabolism in aging
      and in maintenance of bone mass. The limited understanding of vitamin K metabolism impedes
      the establishment of dietary recommendations for vitamin K, and the interpretation of results
      from clinical trials on vitamin K supplementation and bone health of women in a narrow age
      group. This study is the first to assess the role of dietary and other factors that influence
      the response to vitamin K status and bone turnover to vitamin K depletion and repletion in
      adults. This study also compares the absorption efficiency and body retention of vitamin K
      relative to current vitamin K status. Men and women [21 younger (18-40y) and 21 older (55+y)]
      will participate in a 62-d metabolic study, with a 5d run-in period, followed by a 28d
      dietary vitamin K restriction period (10 ug/d), and ending with a 28d dietary vitamin K
      supplementation period (500 ug/d). Coagulation times will be monitored during the dietary
      restriction period. Serial measurements of vitamin K status markers and of bone turnover
      markers will show the response of vitamin K to dietary manipulation for both age groups under
      identically controlled dietary conditions. Deuterium-labeled vitamin K in collards will be
      used to compare the absorption of vitamin K during a vitamin K-deplete state to that of a
      vitamin K-replete state. Vitamin K is transported in triglyceride-rich lipoproteins, which
      may vary among individuals due to differences in adiposity and lipid homeostasis. Therefore,
      measurement of body composition by Dual Energy X-Ray Absorptiometry (DXA) and plasma lipids
      will provide insight into the role of lipids in absorption and transport of vitamin K. The
      findings of this study are critical for the interpretation of the epidemiologic and clinical
      data used to determine the protective role vitamin K may have in chronic disease prevention.
    

Intervention name(s): Vitamin K
Intervention type(s): Drug
Intervention description(s): phylloquinone (vitamin K1) 500 mcg daily in third month
Other intervention name(s): phylloquinone
Intervention MeSH terms: Vitamin K; Vitamin K 1
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Vitamin K metabolism; Bone health; Metabolism
Clinical Evaluation of the CM-1500 in Postoperative Surgery Patients
Condition: Blood Loss
MeSH terms: Hemorrhage
Study type: Interventional

Summary: 
      The primary objective is to evaluate the the changes in the Relative Index in post abdominal
      or pelvic surgery patients on the Cardiac Monitor Model CM-1500.
    

Detailed description: 
      Postoperative hemorrhage incidence can vary depending on the type of surgery, but it can lead
      to severe clinical complications ranging from mild anemia to fatal hemorrhagic shock.
      Monitoring and detecting these fluid changes postoperatively can be complicated, and standard
      operating procedures vary. The Cardiac Monitor, Model 1500 (CM-1500), uses a personalized
      approach by non-invasively and simultaneously monitoring five (5) physiological parameters.
    

Intervention name(s): CM-1500
Intervention type(s): Device
Intervention description(s): Blood volume monitor CM-1500
Intervention model: Single Group Assignment
Intervention model description: The study is a prospective, single-arm, non-randomized, non-controlled, single-center study enrolling adult subjects.
Masking: None (Open Label)
Primary purpose: Diagnostic
Bio-signal Telemonitoring Using Electronic Textiles in a Pediatric Population
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      There is a need for developing reliable and convenient technologies for telemonitoring of
      physiological signals such as respiration, cardiac function, and activity level in children
      and especially for those with heart disease. Changing symptomatology causes heart failure
      patients to seek medical attention in order to be assessed and potentially have medication
      adjusted or additional testing being undertaken. These frequent clinical encounters affect
      the quality of life of these children and their parents, as well as being costly for the
      health care system. A textile based technology for telemonitoring application that is
      comfortable and accurate in its data collection can help to provide real time information on
      physiologic parameters. The primary research objective is to determine the feasibility and
      validity of a textile-enabled sensor system in measuring physiologic variables, or
      "biological signals", related to cardiopulmonary function in children. The study will include
      10 patients with heart failure, and 10 healthy controls.
    


Intervention name(s): Myant SKIIN Device
Intervention type(s): Device
Intervention description(s): Supine position: Participant lays on a bed on their back for 5 minutes
Sitting position: Participant sits on a chair for 5 minutes
Standing position: Participant stands for 5 minutes.
Exercise measurement: treadmill exercise test - the protocol entails increases of 0.5 mph every minute with zero change in the incline. Starting point would 1.5 mph. The test will be interrupted if the target heart rate of 190 beats per minute is reached or if symptoms and/or arrhythmias and ST depression would be observed. Patient will be monitor during recovery for 5 minutes.
Cool-down: Participants cool-down for 5 minutes
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pediatric; Smart Device; Remote monitoring
A Study of Calcitriol BID Topical Treatment in Adolescents With Plaque Psoriasis
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label, multicenter study to assess the systemic exposure to calcitriol in the
      adolescent population. Calcitriol 3µg/g ointment (2 mg/cm² per application) is to be applied
      twice daily to involved skin (10 - 35% BSA involved, excluding face, scalp and intertriginous
      areas) for 56 days (8 weeks). Full Pharmacokinetic (PK) and Pharmacodynamic (PD) profile will
      be collected during the first 3 weeks of the study; safety and efficacy data will be
      collected for the 8 weeks of the treatment.
    


Intervention name(s): Calcitriol 3mcg/g
Intervention type(s): Drug
Intervention description(s): Calcitriol 3mcg/g ointment applied twice daily for 56 weeks.
Other intervention name(s): CD2027; Vectical
Intervention MeSH terms: Calcitriol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Calcitriol; Psoriasis; PK; Adolescents
Impact of Opportunistic Salpingectomy on Ovarian Reserve in Patients Undergoing Laparoscopic Hysterectomy
Condition: Benign Uterine Disease
MeSH terms: Uterine Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      Recently, many gynecologic oncologists proposed that surgeons should consider opportunistic
      salpingectomy to prevent ovarian cancer for all patients undergoing hysterectomy for benign
      disease. However, the safety and the consequences regarding ovarian function after
      salpingectomy have not yet to be established. Therefore, the aim of this randomized
      controlled study is compare the ovarian reserve via anti-Müllerian hormone (AMH) between
      laparoscopic hysterectomy (LH) alone and LH combined with salpingectomy.
    


Intervention name(s): LH alone; LH with opportunistic salpingectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): LH, laparoscopic hysterectomy; LH, laparoscopic hysterectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Physiological Behavior of Respiratory Maneuvers
Condition: Healthy Volunteers
Study type: Observational

Summary: 
      Introduction: new methods of evaluation of respiratory function, such as electrical impedance
      tomography (EIT) and optoelectronic plethysmography (OEP), have been used to measure regional
      pulmonary ventilation and the variation of tricompartmental volumes of the thoracic cavity,
      respectively. Analysis of these instruments during maximal respiratory maneuvers with
      monitoring of esophageal pressure may probably provide additional information on the
      physiological behavior of the cardiorespiratory system during EIT and OEP maneuvers.
      Objectives: To describe the physiological behavior of maximal respiratory maneuvers through
      the electrical impedance tomography and optoelectronic plethysmography in healthy men.

      METHODS: This is a cross-sectional study involving 10 healthy male volunteers. The
      development of the method will take place in 3 stages. The first step corresponds to the
      characterization of the inspiratory and expiratory curves in the respiratory cycle generated
      by the impedance variation (ΔZ), the mobility of the chest wall and the pulmonary volume
      curve during maximal respiratory maneuvers. 2nd stage: verification of the correlation
      between the variables Step 3: Estimate the dislocated blood volume of the lung through
      previous analyzes.
    

Detailed description: 
      The physiological repercussions resulting from the maximal respiratory maneuvers together
      with the synchronized analysis of the chest cavity mobility, pulmonary volume , pulmonary
      impedance and measurement of Oesophageal pressure is not known. Therefore, this study aims to
      describe the physiological behavior of maximal respiratory maneuvers through the
      synchronization between electrical impedance tomography and optoelectronic plethysmography in
      healthy men.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study sample will be composed of healthy male volunteers.
A Study of Rapastinel as Adjunctive Therapy in the Prevention of Relapse in Patients With Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy, safety and tolerability of rapastinel 450 milligrams
      (mg) intravenous (IV) once weekly or once every 2 weeks versus placebo as an adjunctive
      treatment to ongoing anti-depressive therapy (ADT) in the prevention of relapse in
      participants with Major Depressive Disorder (MDD).
    


Intervention name(s): Rapastinel; Placebo-matching Rapastinel
Intervention type(s): Drug; Drug
Intervention description(s): Rapastinel pre-filled syringes for IV injections.; Placebo-matching rapastinel pre-filled syringes for weekly IV injections.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Colonoscopy Motivation for Patients With Positive Immunochemical Fecal Test
Condition: Colon Cancer
MeSH terms: Colonic Neoplasms
Study type: Interventional

Summary: 
      Patients with an immunochemical fecal test positive, have to undergo a colonoscopy. Around
      10% doesn't realize the colonoscopy. This study evaluate the impact of a motivational phone
      call (given by a doctor) to improve colonoscopy participation. And try to understand why this
      patients don't want to make this examination.
    


Intervention name(s): Colofit+ intervention
Intervention type(s): Behavioral
Intervention description(s): Personnalized phone call, done by the medical student in the name of Adémas-69, organized cancers screening in the Rhône area association. This is a motivational call to encourage patients with an immunochemical fecal test positive, to realized their colonoscopy.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: colonoscopy; immunochemical fecal test; screening
Expression of EPK in Recurrent Miscarriage
Condition: Recurrent Miscarriage
MeSH terms: Abortion, Spontaneous; Abortion, Habitual; Recurrence
Study type: Observational

Summary: 
      The present study is based on hypotheses that some as yet unknown genetic factors may result
      in recurrent miscarriage (RM). Consequently, the main aim of this study was to gain new
      information about the underlying genetic causes of RM in the Egyptian population and to
      investigate the expression of ERK and p-ERK protein in human placenta and their corresponding
      tissue, to assess the significance of MAPK signal pathway in progression of recurrent
      miscarriage and PI3K-Akt Pathway.
    


Intervention name(s): Investigate the MAP kinase signaling pathways through ERK and p-ERK proteins
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women fulfilling the eligibility criteria had been tested and complete history and
        examination was done
      
Keywords: genetic basis
A Study of Cetrelimab in Participants With Chronic Hepatitis B Virus Infection
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Virus Diseases; Herpesviridae Infections; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to characterize the pharmacokinetic (PK) profile of cetrelimab
      administered subcutaneous (SC) and optionally intravenous (IV) in chronic hepatitis B (CHB)
      participants.
    

Detailed description: 
      Hepatitis B virus (HBV) is a small deoxyribonucleic acid (DNA) virus that infects the liver
      and can cause either acute (less than 6 months) or chronic (more than 6 months) infection.
      Persistence of HBV infection requires antigen-specific immune tolerance that prevents
      clearance of infected cells. Cetrelimab (JNJ-63723283) is a fully human immunoglobulin (Ig)
      G4 kappa monoclonal antibody (mAb) that binds to programmed cell death receptor-1 (PD-1) with
      high affinity and specificity. PD-(L)1 inhibitors could possibly reverse the immune
      dysfunction from HBV. The study will be conducted in 3 phases: a screening phase (6 weeks), a
      single dose intervention phase (1 day), and a 24-week follow-up phase. The duration of
      individual participation will be up to 30 weeks. Key safety assessments include monitoring of
      Adverse Events (AEs), physical examination, vital signs, Electrocardiogram (ECGs), Injection
      site reaction (ISRs), Infusion-related reaction (IRRs), and clinical laboratory tests.
    

Intervention name(s): Cetrelimab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Cetrelimab (Dose 1 and Dose 2) will be administered via SC injection or as an IV infusion.; Placebo will be administered via SC injection or as an IV infusion.
Other intervention name(s): JNJ-63723283
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Long Term Outcome of Argon Plasma Coagulation of Cervical Heterotopic Gastric Mucosa as an Alternative Treatment for Globus Sensations
Condition: Globus Sensations in the Throat
MeSH terms: Globus Sensation
Study type: Observational

Summary: 
      APC of gastric inlet patches is successful for the treatment of globus sensations in the
      throat (Bajbouj et al Gastroenterology 2009; 137:440-4). There is no data for long term
      efficiency of this treatment. To measure long term efficacy all patients treated with this
      therapy in our clinic were followed up with complaint-evaluation sheets and endoscopy.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        outpatient clinic of a university hospital
      
Biospecimen description: 
      biopsy of gastric inlet patches
    
Keywords: gastric inlet patches; argon plasma coagulation; globus sensations
Comparative Study Between Hydrocortisone and Mannitol in Treatment of Postdural Puncture Headache
Condition: Headache
MeSH terms: Post-Dural Puncture Headache; Headache
Study type: Interventional
Phase: Phase 4

Summary: 
      Fifty patients of both sex, aged 18-50 years and ASA I and II undergoing elective lower
      abdominal and pelvic surgery under spinal anesthesia were included in this randomized
      double-blind study. Patients were randomly divided into 2 groups 25 each; group (I) received
      intravenous hydrocortisone 100mg every 8 hours for 48 hours and group (II) received
      intravenous infusion of mannitol 20% 100ml over 30 minutes followed by 100ml every 12hours.
      Mean (+/- SD) of headache intensity at 0, 6, 12, 24 and 48 hours after beginning of treatment
      was assessed using visual analog scale.
    


Intervention name(s): hydrocortisone 100mg.; mannitol 20% intravenous fluid
Intervention type(s): Drug; Drug
Intervention description(s): Group (I), received hydrocortisone 100mg, dissolved in 2ml normal saline, intravenously/8 hours for 48 hours; group (II), received mannitol 20% 100ml intravenously which was given over 30 minutes and followed by 100 ml on a 12hour basis. Urinary catheter was inserted for patients in group (II) under complete aseptic conditions by the anesthesia resident before the start of mannitol infusion and removed after its discontinuation, accompanied by the intravenous fluid infusion over 48 hours of 500ml of normal saline or Ringer's solution every 8 hours and the input/output fluid chart for evaluation of fluid balance.
Other intervention name(s): (Hydrocortisone as sodium succinate, vial, equivalent to hydrocortisone 100mg, Egyptian INT, Pharmaceutical Industries CO. ARE,EIPICO.EGYPT); mannitol 20% (Manufactured by Allmed Middle East, Egypt).
Intervention MeSH terms: Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Mannitol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this historical-controlled trial is to demonstrate the efficacy and safety
      of conversion to Lacosamide monotherapy in subjects with Partial-onset Seizures who are
      withdrawn from 1 to 2 marketed antiepileptic drugs.
    

Detailed description: 
      Sudden unexplained death in epilepsy have been reported in epilepsy patients. A causal
      relationship with the administration of antiepileptic drugs has not been established. The
      most important known risk factor for sudden unexplained death in epilepsy (SUDEP) is the
      occurrence and frequency of generalized tonic-clonic seizures (GTCS). Twenty-seven patients
      with only GTCS were enrolled in the conversion to monotherapy study. In this study, two
      patients with only GTCS had SUDEP. Due to the potential increased risk of SUDEP in patients
      with only GTCS in a trial setting, the 1 remaining patient with only GTCS was withdrawn from
      this study.
    

Intervention name(s): Lacosamide; Lacosamide
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.; 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.
Other intervention name(s): Vimpat; Vimpat
Intervention MeSH terms: Lacosamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Epilepsy; Partial Onset Seizures; Lacosamide; Monotherapy; Vimpat
Smartphone Rehabilitation App For Stroke Survivor
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This is a pilot study of a smartphone app in which the tool will be developed and validation
      of the tool will be done for the rehabilitation of upper limb in stroke survivors. The study
      will be divided into two phases. The first phase will be the development of a smartphone app
      for upper limb function. The second phase of the study will be a pilot study where 10 stroke
      patients will be recruited and upper limb intervention will be applied through a smartphone
      app.
    


Intervention name(s): Smartphone Rehabilitation Application
Intervention type(s): Device
Intervention description(s): Upper Limb Exercise Protocol:
Passive Exercises
ROMs for shoulder, ROMs for elbow, ROMs for wrist,fingers and thumb
Active/Assisted Exercises
bilateral shoulder flexion with both hands interlocked, Elbow pronation and supination, Wrist flexion and extension with the help of unaffected hand, Forearm to box, Extend elbow (side), Hand to box (front)
Functional Activities
Lift can, Lift pencil, Lift paper clip, Stack checkers,Flip cards, Fold towel, drinking water from a glass, lifting a glass of water to a level of 90° shoulder flexion with an extended elbow, moving 5 crystals from the table to a box, wiping the table with a towel with the elbow extended, grasping and releasing a 6 cm in diameter tennis ball, combing their hair, Eating with affected hand, opening and closing jars
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stroke; CVA
Enthesis Differences in Rheumatoid Arthritis and Axial Spondyloarthropathy
Condition: Axial Spondyloarthritis; Rheumatoid Arthritis; Enthesitis; Enthesopathy
MeSH terms: Spondylitis; Arthritis; Arthritis, Rheumatoid; Spondylarthritis; Axial Spondyloarthritis; Spondylarthropathies; Enthesopathy
Study type: Observational [Patient Registry]

Summary: 
      The aim of this study is to investigate the sonographic differences in entheses in patients
      with Rheumatoid arthritis and Axial Spondyloarthropathy.
    

Detailed description: 
      After recording the demographic data of the patients; 5 enthesis regions 5 enthesis sites
      were evaluated bilaterally as ''tricipital tendon (TT), quadricipital tendon (QT), proximal
      patellar tendon (PPT), distal patellar tendon (DPT), achilles tendon (AT)'' will be
      sonographically evaluated and the presence of hypoechogenicity , tendon thickness increase,
      power Doppler activity, erosion, presence of entezophyte/calcification will be investigated.
      The differences between the groups will then be compared.
    

Intervention name(s): ULTRASOUND
Intervention type(s): Other
Intervention description(s): 10 enthesis areas will be evaluated in 20 minutes with ultrasound.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Rheumatoid arthritis patients identified according to the 2010 American College of
        Rheumatology /Europan Leage Against Rheumatism classification criteria, axial
        Spondyloarthrtis patients identified according to the Assessment of Spondyloarthritis
        classification criteria and healthy controls with no history of rheumatic diseases.
      
Keywords: Axial Spondyloarthritis,; Rheumatoid Arthritis; Enthesitis; Ultrasound