bioihbjkbjnl/mcl2 huggingface dataset:
Immunosuppression and Diet: the Role of Inflammation in the Adipose Tissue Remodeling
Condition: Obesity; Liver Transplantation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The main goal of this project is to evaluate the effect of immunosuppression in the weight
      loss and in the metabolic status of patients after liver transplantation. It is also the
      purpose of this project to investigate why patients become overweight and obese after liver
      transplantation.
    

Detailed description: 
      Overweight and obese post-liver transplantation patients will receive a diet to promote
      weight loss during 6 months. The control group (overweight and obese subjects) will be
      submitted to the same protocol:

      The participants will be interviewed at baseline and after 30, 60, 90 and 180 days from
      baseline. The following measures will be assessed: body composition (fat body% and free fat
      body%), anthropometric measures (height, weight, body mass index, waist circumference and
      abdominal circumference), blood pressure, basal metabolic rate, behavioral symptoms and
      peripheral biomarkers in the serum. Behavioral symptoms will be assessed using the following
      self-reported questionnaires: Beck Depression Inventory (depression symptoms), Beck Anxiety
      Inventory (anxiety symptoms), Medical Outcomes Study 36 - Item Short - Form Health Survey
      (quality of life) and Perceived Stress Scale (stress).

      Enrolled participants will receive a restrictive diet calculated based on individual
      requirements aiming the loss of around 5%-10% of weight/ 6 months of intervention.
    

Intervention name(s): Weight loss diet
Intervention type(s): Other
Intervention description(s): Weight loss diet composed of 30% lipids, 30% proteins and 40% carbohydrates.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Obesity; Liver transplantation; weight loss diet; immunosuppression
Sensory Re-Training Following Facial Surgery for Correction of Facial Skeletal Disharmony
Condition: Mandibular Advancement
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether facial exercises in conjunction with
      opening exercises routinely provided after facial surgery to correct a facial skeletal
      disharmony will shorten the time until a patient receives no unpleasant or negative facial
      sensation.
    

Detailed description: 
      Abnormal facial sensation has a negative impact on patients' oral behaviors and may adversely
      affect a patient's quality of life if the altered sensation persists. Many patients with
      abnormal sensations retain some sensory function and do not develop chronic pain, and for
      those individuals there are currently no evidence-based noninvasive therapies. The goal of
      this project is to evaluate sensory re-training, a rehabilitative therapy that offers
      significant potential for patients who experience impaired sensory function regardless of the
      cause. This behavioral therapy approach has been used with substantial clinical success with
      hand injury patients since the 1970s. Re-training appears to enhance central reorganization
      of impulses from an injured sensory nerve to the cerebral cortex so that the altered sensory
      signals can be interpreted and translated into functionally meaningful motor functions.

      Sensory re-training will be compared to a placebo jaw-opening exercise in a single blind,
      randomized two-arm parallel group stratified block clinical trial, using orthognathic surgery
      patients as subjects. Orthognathic surgery patients offer an uncompromised model for the
      evaluation of new rehabilitative therapies. These healthy individuals, treated to correct
      dentofacial deformity, present for surgery with no neurosensory impairment, but yet routinely
      experience substantial alterations in facial sensation following the surgical procedure. The
      effects of sensory re-training will be evaluated using three types of outcomes:
      patient-centered measures to assess the magnitude of the negative effect of altered sensation
      after surgery and the recovery time needed to reach little or no negative effect;
      neurosensory behavior measures to assess the patient's ability to learn alternate cues for
      touch perception and discrimination; and a conventional neurosensory contact threshold
      measure to assess the actual deficit. Our primary focus will be on the patient's perception
      of the negative impact of altered sensation on daily life.
    

Intervention name(s): Sensory Re-training; Sensory Retraining; Opening Exercises
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Facial Exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Outcome and Process Assessment (Health Care); Behavior Control; Sensation; Randomized Controlled Trials; Adolescent; Adult
Using Gum Arabic for Cancer Patients to Protect From Oral Mucositis Caused by Chemotherapy: ِِِAn Experimental Study
Condition: Chemotherapy-induced Oral Mucositis
MeSH terms: Mucositis; Stomatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was designed to investigate the effect of Gum Arabic (GA) on cancer patients to
      prevent chemotherapy-induced oral mucositis. Cancer patients who will receive chemotherapy
      were divided into two groups; study "Gum Arabic" group (which received GA with chemotherapy)
      and control group (chemotherapy alone); and the participants were recruited to reach 190
      patients in the study group and 184 patients in control group. This clinical trial was
      conducted in outpatient chemotherapy sections at Radiation and Isotopes Center of Khartoum.
      This study was designed to test the theory that say the chemotherapy-induced oral mucositis
      will significantly decrease after ingestion 30 grams as daily dose of Gum Arabic in a form of
      solution for six weeks during therapy.
    


Intervention name(s): Gum Arabic; Chemotherapy; Lifestyle counseling
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): Gum acacia, also known as Gum Arabic is exuded from acacia trees; mainly from Acacia Senegal (gum Hashab or Kordofan gum) which was used in this study.; Patients of control group and study group (Gum Arabic group) received chemotherapy according to type and stage of cancer.; Lifestyle counseling pertaining to the optimal nutrition and daily routine for oral hygiene.
Other intervention name(s): Acacia Senegal; Chemotherapy agents
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is an experimental study. It was a two-arm randomized, controlled, open-label trial. The patients was categorized into two groups; study group and control group. Patients of study group was received a dose of 30 grams Gum Arabic per day as oral solution (dissolved in 250 ml purified water) for six weeks along with the chemotherapy prescribed, while patients of control group was received only chemotherapy regimen.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Gum Arabic; Cancer patients; Chemotherapy; Oral mucositis
Analysis of Implant Placement in Patients With Distal Radius Fractures in Western Brittany (REDIRA)
Condition: Distal Radius Fracture
MeSH terms: Fractures, Bone; Radius Fractures; Wrist Fractures
Study type: Observational

Summary: 
      The purpose of this study was to determine the impact of design on plate position at the
      level of the distal radius. Six anterior wrist plates design were analyzed relative to the
      watershed line using the Soong classification. A total of 2723 anterior locking plate
      fixation cases were analyzed and divided into six groups: Zimmer Biomet, Newclip Technics,
      Stryker, Synthes, Medartis and Medartis Footprint. The number of plates recorded as Soong
      grade 0+1 was determined for each design, then compared using the Marascuilo procedure. The
      Zimmer Biomet and Newclip plates were proximal to the Watershed line significantly more often
      than those by Synthes and Medartis Footprint. Plate position with the Medartis design was
      significantly more proximal to the Watershed line compared to its companion design, the
      Medartis Footprint plate. Plate design is a deciding factor when treating distal radial
      fractures, to avoid impingement when implant removal is not routinely planned.
    

Detailed description: 
      This is a retrospective multicenter study involving several orthopedic surgeons with a trauma
      surgery practice within the public hospital centers of the department of Finistère. These
      include the CHU de Brest - Brest University Hospital Center (La Cavale Blanche), the HIA
      Clermont-Tonnerre military hospital (Hôpital d'Instruction des Armées - Armed Forces Teaching
      Hospital), the CH des Pays de Morlaix, the CH de Landerneau Ferdinand Grall, the CH de
      Carhaix and the CH de Cornouaille Quimper Concarneau. This study was approved by the local
      ethics committee. Among the cited hospital centers, the CHU de Brest is a level 1 trauma
      center, the CH des pays de Morlaix, the HIA military hospital and the CH de Cornouaille are
      level 2 trauma centers and the CH de Landerneau and Carhaix are level 3 trauma centers.
    

Intervention name(s): Distal radius fracture ORIF with a specific volar plate
Intervention type(s): Procedure
Intervention description(s): Patients who had a distal radius fracture were treated surgically : an ORIF was realised with a volar plate
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        We included all patients with an intra-articular or extra-articular distal radial fracture
        managed by Volar Locking Plate fixation.
      
Keywords: Distal Radius fracture; Volar plate; Plate design; Watershed line; Plate positioning
Effect of Crystalloids With Different SID on pH, and Urinary Electrolytes During General Anesthesia
Condition: SID; Acid-Base Imbalance
MeSH terms: Acid-Base Imbalance
Study type: Interventional

Summary: 
      The present study will investigate variations in acid base equilibrium caused by the
      administration of four different crystalloids with increasing strong ion difference (0.9%
      saline, Ringer's lactate, Ringer's acetate, plasmalyte-like solution) in patients during
      general anesthesia.

      The same crystalloid will be administered throughout the surgery. In order to assess the
      effect of hemodilution, every patient will receive two fluid boli with different volumes of
      the same solution. pH and strong ion variations, togher with the renal response to acid base
      disturbances, will be analysed.
    


Intervention name(s): 0.9% saline administration; Ringer's lactate administration; Plasmalyte-like solution administration
Intervention type(s): Other; Other; Other
Intervention description(s): Each patient will receive 0.9%saline based on attending physician decision; Each patient will receive Ringer's lactate based on attending physician decision; Each patient will receive Plasmalyte-like solution based on attending physician decision
Intervention MeSH terms: Plasma-lyte 148
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: pH; crystalloids
Polyphenols Supplementation on Prostaglandin E2 in Women - Randomized Clinical Trial
Condition: Inflammatory Disorder of the Cardiovascular System
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study was to evaluate the effect of polyphenol supplementation on plasma
      levels of prostaglandin E2 in women during the reproductive period.
    

Detailed description: 
      The effect of anti-inflammatory substances on the constriction of the fetal ductus arteriosus
      is well documented, but the anti-inflammatory property of polyphenols and their effect on the
      metabolism of prostaglandins are not established. Evidence indicates that foods rich in
      polyphenols consumed from the third trimester of pregnancy may interfere with anatomical and
      functional activity of the fetal heart, presumably by the action similar to anti-inflammatory
      drugs nonsteroidal, causing inhibitory effect on prostaglandin synthesis. Objective: The
      objective of this study was to evaluate the effect of polyphenol supplementation on plasma
      levels of prostaglandin E2 in women of childbearing age use of hormonal contraceptives. As
      secondary endpoints were also evaluated other markers of inflammation and oxidative stress.
      The selected women were randomized to receive capsules polyphenol at a concentration of 3000
      mg / day or placebo capsules to be consumed daily for fifteen days. Was applied dietary
      recall to assess intake of polyphenols, measured height and weight and carried blood samples
      for prostaglandin analysis E2 (PGE2), high sensitive C-reactive protein, and urine for
      analysis of total polyphenols and F2 isoprostane (8 iso-PGF2a). Statistical analysis: The
      results will be expressed through absolute and relative frequencies and mean ± standard
      deviation (SD) or median and interquartile range. For analysis, Pearson correlation is used.
      To compare the means will be used Student's t test. The level of significance is 5%.
      Considering a 90% power, with absolute error margin of 5% in the present study, 13 patients
      were needed in each group.
    

Intervention name(s): Polyphenols; Placebo controlled
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Capsules with five substances (polyphenols) at a concentration of 3000mg per day; Starch capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Polyphenols, Prostaglandin E2, hormonal contraceptives
What is the Incidence of an Immune Disorder in Children With Invasive Pneumococcal Disease (IPD)?
Condition: Invasive Pneumococcal Disease, Recurrent Isolated, 1; Invasive Pneumococcal Disease, Recurrent Isolated, 2; Invasive Pneumococcal Disease, Protection Against; Primary Immunodeficiency
MeSH terms: Pneumococcal Infections; Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Recurrence
Study type: Observational

Summary: 
      This is a multicentre prospective audit to determine the incidence of immunodeficiency in
      children with IPD.

      Aims and/or research question of the project

        1. To determine the incidence of primary immunodeficiency in children >2 years who present
           with IPD

        2. To determine the types of immunodeficiency associated with IPD in children
    


Intervention name(s): Referral to Immunology
Intervention type(s): Other
Intervention description(s): Screening for primary immunodeficiency including splenic dysfunction
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children presenting with invasive pneumococcal disease at any of the participating sites
        listed.

        Invasive pneumococcal disease is defined by isolation by culture or PCR of Streptococcus
        pneumoniae from sterile sites including blood, cerebrospinal fluid (CSF), joint fluid or
        pleural fluid. In those patients with bacteraemia, their presentation needs to be
        accompanied by signs of sepsis.
      
Keywords: streptococcus pneumoniae; invasive pneumococcal disease; primary immunodeficiency
Impact of Esmya on Fertility to Infertile Women With Fibroids Managed With Assisted Reproduction Techniques
Condition: Infertility, Female; Fibroid Uterus
MeSH terms: Leiomyoma; Myofibroma; Infertility; Infertility, Female
Study type: Observational

Summary: 
      Fibroid is a frequent pathology of infertile women. Its deleterious effect on the infertility
      would be due to the mechanical way.

      The interest of the resection of intramural fibroids is discussed. It is necessary to measure
      the indication of a myomectomy, whatever the surgical procedure. On the one hand, it may
      cause important potential complications, and on the other hand, the surgery does not improve
      the parameters of the fertility.

      Thus, it is a major stake to avoid the surgical operation. A decrease of the size of these
      fibroids by medical treatment is then a good option.

      When the surgical treatment is necessary, a medical pre-surgical treatment is often proposed
      in order to decrease the symptomatology and to reduce the size of the fibroid to facilitate
      the surgery.

      Acetate Ulipristal (UPA) has been marketed in this indication. Following the Pearl I-II
      studies, the first indication in France was a pre-surgical treatment for 3 months at a dose
      of 5 mg per day.

      The Pearl III and IV studies evaluated the Esmya® administration as a long-term intermittent
      repeated treatment, giving to it a prominent position for the long-term management of
      symptomatic fibroids.

      Furthermore, cases of pregnancy before surgery are frequently described in women with
      fibroids treated by UPA for a pre-IVF surgery.

      5 to 10 % of women who are managed for infertility have fibroids and only 2% to 3% have this
      unique cause of infertility.

      Then, some of patients followed in ART centers have been treated by UPA to reduce the
      fibroids size and/or to decrease the associate symptoms.

      The aim of this study is to evaluate in the different French ART centers, the impact on
      fertilization of UPA administration for infertile women with fibroids and to describe the
      modalities of its prescriptions and to collect information regarding safety tolerance profile
      of Esmya® in this patient population.
    

Detailed description: 
      A retrospective, national, multicenter study
    

Intervention name(s): ULIPRISTAL ACETATE
Intervention type(s): Drug
Intervention description(s): Ulipristal Acetate (Esmya) administrated for fibroids indication before surgery and IVF/ICSI procedure(retrospective study)
Intervention MeSH terms: Ulipristal acetate
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Infertile women with fibroids managed with assisted reproduction techniques (ART)
The iPeer2Peer Program for Adolescents With Juvenile Idiopathic Arthritis
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional

Summary: 
      The iPeer2Peer program matches teens with arthritis to an older mentor who has learned to
      manage their arthritis well and can support them emotionally and socially. This study will
      compare two groups of teens: those who are in the iPeer2Peer Program and those in the control
      group (no mentor).
    

Detailed description: 
      Arthritis is a common childhood illness that makes everyday activities hard for young people.
      It is a long-lasting illness that can make you feel pain, tired and emotionally upset. This
      can make it hard for children and teens to see friends and do the activities that they like.
      The goal of this project is to find out if the newly developed peer mentoring program called
      iPeer2Peer helps teens with arthritis take better care of their illness and feel more
      connected to other people with arthritis. The iPeer2Peer program matches teens with arthritis
      to an older mentor who has learned to manage their arthritis well and can support them
      emotionally and socially. This study will compare two groups of teens: those who are in the
      iPeer2Peer Program and those in the control group (no mentor).
    

Intervention name(s): iPeer2Peer Mentorship; Active Comparator: Control Group
Intervention type(s): Behavioral; Other
Intervention description(s): 10 sessions of 20-30 minute Skype calls conducted over 5-12 weeks.; The control group will receive standard care but without the iPeer2Peer program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Fluid Responsiveness Using Forehead Sensor in Children
Condition: Hypovolemia
MeSH terms: Hypovolemia
Study type: Interventional

Summary: 
      Forehead sensor can predict the more accurate fluid responsiveness than finger sensor in
      children
    

Detailed description: 
      The investigator hypothesized that the forehead sensor can predict the fluid responsiveness
      more accurate than the finger sensor in pediatric patients.
    

Intervention name(s): fluid resuscitation
Intervention type(s): Other
Intervention description(s): when the patients showed the clinical signs of hypovolemia, the fluid resuscitation with 10ml/kg crystalloid solution was performed.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Drug Naive Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a
      single oral drug. The purpose of this study is to assess the safety and effectiveness of the
      combination of vildagliptin, an unapproved drug, and pioglitazone in lowering overall blood
      glucose levels in people with type 2 diabetes who have not previously been treated with drug
      therapy to lower their blood sugar.
    


Intervention name(s): vildagliptin
Intervention type(s): Drug
Intervention MeSH terms: Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: type 2 diabetes; vildagliptin
Intravenous Remifentanil for Labor Analgesia
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Labor analgesia is an essential health caring procedure for women. However, epidural
      analgesia cannot be performed on all subjects for different contraindications, such as lower
      platelet counter, back infection at the puncture site, and fear of epidural injection etc.
      Therefore, intravenous analgesia is an alternative for such conditions. Given the influence
      of intravenous administration of drugs on fetus, the drug selection is very important.
      Remifentanil, a super-short efficacious opioid, can last for 3-4 minutes after injection,
      which is similar in both maternal and fetal environment. Thus the fetus-associated side
      effects would be less than other drugs. The investigators hypothesized that remifentanil
      would be a superior intravenous drug used with patient-controlled technique for labor
      analgesia.
    


Intervention name(s): Hydromorphone; Remifentanil
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous administration of hydromorphone 1mg at the patient's request if they felt uterine contraction pain; Remifentanil intravenous PCA: 0.2μg/kg, lockout time interval 2 minutes, continuous infusion rate 0.2-0.8μg/kg/min.
Other intervention name(s): ReiFen
Intervention MeSH terms: Remifentanil; Hydromorphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Remifentanil; Patient-controlled analgesia; Intravenous analgesia