bioihbjkbjnl/mcl2 huggingface dataset:
Diazoxide-Mediated Insulin Suppression in Hyperinsulinemic Obese Men
Condition: Obesity; Hyperinsulinism
MeSH terms: Hyperinsulinism
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to explore diazoxide efficacy in treatment of obese men and
      assessment of maximal insulin suppression in obese men without hyperglycaemia.

      Obesity is associated with markedly elevated plasma insulin levels throughout the day. The
      concept is that obese subjects predominantly develop lean tissue resistance against the
      glucoregulatory actions of insulin, but remain relatively sensitive to the lipogenic and
      antilipolytic effects of insulin in adipose tissue. According to this theory, suppression of
      hyperinsulinism by diazoxide, a well known inhibitor of glucose stimulated insulin secretion,
      might be useful to treat obesity because it will help to reverse the process of lipid
      storage.
    

Detailed description: 
      The purpose of this study is to explore diazoxide efficacy in treatment of obese men and
      assessment of maximal insulin suppression in obese men without hyperglycaemia.

      Study design:

      This study is an open-labelled, non-randomized, phase IIa study.

      Treatment:

      During a 6 month period, the dosage of Diazoxide will be raised gradually until a maximum of
      900 mg/day, under control of bloodpressure and glucose levels.

      Endpoints, monthly determined:

        -  body weight

        -  abdominal circumference

        -  body composition measured by Dual Energy X-ray Absorptiometry

        -  glucose tolerance
    

Intervention name(s): Diazoxide
Intervention type(s): Drug
Intervention MeSH terms: Diazoxide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Hyperinsulinism; Diazoxide
Using Implementation Intentions to Self-incentivise Weight-loss
Condition: Overweight
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      The aim of the present research is to test the effect of helping people to reward themselves
      when they have successfully lost weight and the impact this will have on subsequent weight.
      Each participant will be randomly allocated to one of four conditions. The trial requires 200
      participants to perform a fully powered statistical analysis. The four conditions are: (1) a
      control condition, (2) intervention 1 (form a single self-incentivising implementation
      intention from a drop-down menu), (3) intervention 2 (form multiple self-incentivising
      implementation intentions from a drop-down menu), or (4) intervention 3 (asked to form a
      single self-incentivising implementation intention of their own devising). The main outcome
      measure will be BMI, which will be self-reported.
    


Intervention name(s): Single self-incentivising implementation intention; Multiple self-incentivising implementation intentions; Self-generated self-incentivising implementation intentions
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants are asked to form a single self-incentivising implementation intention (if-then plans); Participants are asked to form multiple self-incentivising implementation intentions (if-then plans); Participants are asked to form a self-incentivising implementation intention (if-then plans) without a drop-down menu
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Comparison of PHVP of Different VTH Methods
Condition: Vault Prolapse, Vaginal
MeSH terms: Uterine Prolapse; Prolapse; Pelvic Organ Prolapse
Study type: Observational

Summary: 
      To evaluate the post-hysterectomy vault prolapse (PHVP) rates performed using different
      methods of vaginal total hysterectomy (VTH).
    

Detailed description: 
      Objective: To evaluate the post-hysterectomy vault prolapse (PHVP) rates performed using
      different methods of vaginal total hysterectomy (VTH).

      Methods: A computer search identified a total of 251 women who underwent VTH with/without
      concomitant surgeries between January 1986 and December 2001 in a single center. Thirty-eight
      women were excluded due to not only a vaginal approach. Of the remaining 213 women, 129 and
      84 underwent VTH via the Tsuzi method with residual uterine ligament ligation (ligations
      group) and traditional VTH (without ligations group), respectively. The χ2 and Mann-Whitney U
      tests were applied to compare the data. The cumulative percentages of women without PHVP were
      calculated over time and compared using Kaplan-Meier curves and log-rank tests. A p value of
      less than 0.05 was considered statistically significant.
    

Intervention name(s): VTH via the Tsuzi method with residual uterine ligament ligation
Intervention type(s): Procedure
Intervention description(s): VTH via the Tsuzi method with residual uterine ligament ligation
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Between January 1986 and December 2001, all women who received VTH with or without other
        combined operations at National Taiwan University Hospital were recruited. In September
        2016, a retrospective chart review was performed.
      
Keywords: Vault prolapse; Vaginal total hysterectomy
Evaluation of Multifocal Transcutaneous Electrical Stimulation for Self-treatment Among Children With Cerebral Palsy
Condition: Spastic Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The main purpose with this study is to investigate the effectiveness of a garment with
      integrated electrodes for multifocal transcutaneous electrical stimulation intended for
      treatment of spasticity in children with cerebral palsy.
    

Detailed description: 
      The effect and use of the garment will be evaluated in single - case studies using ABAB
      design.
    

Intervention name(s): Mollii ®
Intervention type(s): Other
Intervention description(s): The garment claims to have a 48 hours lasting effect of an hour of treatment. The garment should be worn for at least 1 hour every other day. All participants receive individually tailored garments and individually tailored appropriate training towards specific goals set in connection to study start. The garment is used in the home environment and the family is responsible for documentation of use in a diary. Measurements is performed following an ABAB design for four weeks. Measurement performed at 12 occasions during the four weeks are; spasticity, physical function, pain, sleep and adherence. Standardized protocols for the intervention are provided to involved physical therapists.
Intervention model: Single Group Assignment
Intervention model description: Single case studies
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy & Tolerability of a Specific Plantain,Thyme and Honey Cough Syrup vs Placebo in Child Cough Due to Common Cold
Condition: Cough
MeSH terms: Common Cold; Cough
Study type: Interventional

Summary: 
      Cough is a life saving reflex, therefore it is important, especially in pediatrics, to calm
      cough spells without sedating the reflex. The intent of this study is to use a protective
      syrup with does not act as a sedative or as a potent mucolytic and measure its efficacy and
      safety versus placebo in children with moderate to severe night and daily cough. Cough is
      assessed with a validated parent questionnaire. The degree of disturbance of cough is
      followed immediately after one night administration of the study products and daily for 4
      nights, 3 days.
    

Detailed description: 
      Cough is a life saving reflex, therefore it is important, especially in pediatrics, to calm
      cough spells without sedating the reflex. Looking into mechanisms for cough management
      different from mucolytics, or sedatives, such as protection of irritated pharynx mucosa from
      post nasal drip or other irritating substances is theoretically sound and shows practical
      interesting results.

      A parallel comparison of efficacy and tolerability between such protective mechanism (acting
      through a barrier and radical scavenging action) due to natural substances (honey, plantago
      lanceolata and thymus vulgaris) and placebo has not been done so far, in very young children,
      especially in a time frame of 4 days. The intent of this study is to use the protective syrup
      versus placebo in children with moderate to severe night and daily cough, measured with a
      validated parent questionnaire. The degree of disturbance of cough is followed immediately
      after one night administration of the study products and daily for 4 nights, 3 days.

      Assessment of effectiveness of the protective cough syrup as compared to placebo is
      considered very interesting due to the mechanism of the remedy.
    

Intervention name(s): Cough syrup for adults and children; Placebo
Intervention type(s): Device; Device
Intervention description(s): Dosage is 5 ml three times a day for 4 nights, 3 days; Dosage is 5 ml three times a day for 4 nights, 3 days
Other intervention name(s): Poliflav M.A.-honey cough syrup
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Breast Fat Grafting Augmentation in Chinese Women
Condition: Breast Implantation
Study type: Interventional

Summary: 
      A total of 38 Chinese healthy women underwent autologous fat grafting for cosmetic breast
      augmentation. Breast volumes were measured by magnetic resonance imaging preoperatively and 1
      year after the procedure. Furthermore, BREAST-Q was used to analyze the satisfaction and
      well-being of patients during the preoperative and 1 year post operation.
    

Detailed description: 
      Autologous fat was obtained from thighs, waist or abdomen using resonance liposuction
      instrument. Fat was injected into the tissues in a multitunnel and multilayer way until they
      were firm and appeared fully tumesced according to the Coleman method.All MRI volume analyses
      were blindly performed by examiner independently preoperatively and 1 year postoperatively.
      Object marking was done using avanto 1.5T superconducting magnetic resonance scanner.Volume
      analysis was done by counting pixels within the frames of the MRI using ImageChecker CAD
      software.The Chinese version of BREAST-Q augmentation module was obtained from the Memorial
      Sloan-Kettering Cancer Center and the University of British Columbia. 38 patients were given
      the BREAST-Q questionnaire to express their thoughts preoperatively and 1 year
      postoperatively. Data were calculated using the Q-score program, which converts raw BREAST-Q
      scores of 1 through 4 or 5 to scores of 0 to 100.
    

Intervention name(s): Autologous Fat Grafting
Intervention type(s): Procedure
Intervention description(s): Autologous Fat Grafting
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
18FDG-PET Imaging to Detect Changes in Airways Inflammation in Cystic Fibrosis Patients
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis; Inflammation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if 18Fluorodeoxyglucose (FDG) Positron Emission
      Tomography (PET) imaging can detect changes in airways inflammation in Cystic Fibrosis (CF)
      patients after treatment for a pulmonary exacerbation.
    

Detailed description: 
      Neutrophils play a key role in the pathogenesis of CF lung disease. We know that neutrophilic
      inflammation is related to a decline in pulmonary function. Therefore, early
      anti-inflammatory intervention is an opportunity to slow this irreversible pulmonary
      destruction. However, the development of sensitive, non-invasive diagnostic tools of airways
      inflammation is essential to the study and implementation of anti-inflammatory therapies. Our
      current armentarium of measures of airways inflammation is limited. BAL is invasive and not
      clinically acceptable as a tool for the serial measurement of inflammation. Sputum samples
      are highly variable and not reliable.

      18FDG-PET is a promising tool because it is non invasive, has been shown to quantify the
      amount and location of neutrophilic inflammation and has the potential to be used to track
      inflammation over time. Therefore, the goal of this research study is to evaluate the ability
      of 18FDG -PET imaging to detect changes in airways inflammation in CF patients in response to
      conventional treatment for a pulmonary exacerbation
    

Intervention name(s): 18-FDG
Intervention type(s): Other
Intervention description(s): The administered intravenous dose of 18-FDG is 0.14mCi/kg up to a maximum of 10mCi before each PET imaging scan is performed.
Intervention MeSH terms: Fluorodeoxyglucose F18
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: 18FDG-PET imaging; airway inflammation; cystic fibrosis; pediatric; pulmonary exacerbation
Different Doses of Roxadustat Treatment for Anemia in Peritoneal Dialysis Patients
Condition: Renal Anemia
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 4

Summary: 
      A multi-center, randomized, controlled study to evaluate the effect of different doses of
      roxadustate on hemoglobin target-met in peritoneal dialysis patients
    

Detailed description: 
      Roxadustat is an orally hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) to
      promote erythropoiesis on patients with chronic kidney disease. Two phase 3 clinical trials
      have verified the efficacy and safety of roxadustate as therapy for anemia in patients with
      CKD and undergoing dialysis. A high increasing rate of Hb or Hb overshooting triggered by
      roxadustat need dosing reduction or even drug withdrawal, possibly leading to a large Hb
      variation and adverse subsequences. Therefore, we were of interest to investigate whether a
      lower starting dose of roxadustat could achieve comparable Hb target at week 12 while
      lowering the risk for Hb over 130g/L through a prospective peritoneal dialysis (PD) cohort.
      Peritoneal dialysis patients diagnosed with renal anemia will be divided into standard
      roxadustat dosage group and lower roxadustat dosage group. After 12 weeks, we will compare
      the target-met, overshooting and variation ratio of hemoglobin between these two groups.
    

Intervention name(s): Roxadustat
Intervention type(s): Drug
Intervention description(s): Patients in the standard dosage group will receive starting dosage of roxadustat 100 mg, three times per week for weight 45-60kg and 120 mg, three times per week for weight greater than 60kg. Patients in the lower dosage group will receive the starting dosage of roxadustat 50 mg, three times per week for weight lower than 50kg, 70 mg, three times per week for weight 50-70kg, 90 mg, three times per week for weight 70-90kg and 110 mg, three times per week for weight 90-110kg, respectively.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Roxadustat; renal anemia; Peritoneal Dialysis
ROS Signaling in Endothelial Function
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The vascular endothelium (inner lining of cells in blood vessels) normally prevents vasospasm
      and thrombosis by producing nitric oxide and other regulatory substances. In patients with
      atherosclerosis, endothelial function is impaired. Excess production of reactive oxygen
      species (free radicals) contribute to endothelial dysfunction in atherosclerosis, and some
      prior studies have shown a beneficial effect of antioxidant treatment on endothelial function
      in patients with coronary artery disease. On the other hand, reactive oxygen species may be
      required for normal endothelial function and antioxidant supplements failed to show a benefit
      in large clinical trials. The effect of antioxidant treatment on endothelial function in
      healthy subjects is unknown. The present study will test the hypothesis that scavenging
      reactive species might reduce endothelium-dependent vasodilation in healthy subjects.

      The study is a randomized, double-blind, placebo-controlled crossover study. Participants
      will receive 2.4 grams of oral NAC or similar-appearing placebo during the first visit, and
      then will cross over to the alternative treatment (NAC or placebo) for the second and final
      visit. We will examine endothelial function before and after treatment on each visit.
    


Intervention name(s): N-acetylcysteine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): N-acetylcysteine; Placebo
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: endothelium; cell signaling; N-acetylcysteine; reactive oxygen species
Evaluation of Anti-COVID 19 Pfizer Vaccination Effect on COVID 19 Detection Using Breath Analysis
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      The objective of this study will be to evaluate the effect of vaccination on breath VOC
      content.

      By capturing and analyzing the breath of anti-COVID-19 vaccinated subjects during the period
      of antibody production, the investigators will determine and quantify all the compounds
      associated with the body reaction to the COVID-19 antigen.
    

Detailed description: 
      The objective of this study will be to evaluate the effect of vaccination on breath VOC
      content.

      By capturing and analyzing the breath of anti-COVID-19 vaccinated subjects during the period
      of antibody production, the investigators will determine and quantify all the compounds
      associated with the body reaction to the COVID-19 antigen.

      Rapidly growing serological evidence shows that IgM, IgG, and IgA antibodies against the S or
      N proteins evolve rapidly in the serum of asymptomatic as well as symptomatic COVID-19
      patients within a week of infection or symptom onset and stay elevated with progressing
      disease.

      Since the standard serology testing at Shamir Medical center tracks the presence of IgG only,
      those serologic tests will be conducted before and 48 hours following the second vaccination
      dose.

      Nevertheless, since IgM antibodies are known to be produced by four to seven days following
      the first dose of vaccination, although IgM serology testing cannot be performed, the
      investigators are interested in sampling breath at this time range, in order for them to
      correlate it with the changes in the subjects' physiologic condition.

      Since this is an unknown metabolic volatile compound mixture, the goal will be to identify
      compounds and quantify them with a high level of precision and subsequently correlate them
      with the disease.
    

Intervention name(s): vaccination against COVID19
Intervention type(s): Diagnostic Test
Intervention description(s): subjects will undergo breath biopsy sampling before, 4-7 days post-first vaccination dose, and 7-10 days post-second vaccination dose.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Ultrasound-guided Genicular Nerve Block for Total Knee Arthroplasty.
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The hypothesis is to demonstrate the analgesic non-inferiority of the ultrasound-guided
      geniculate nerve block when compared to the local infiltration analgesia (LIA). It is
      expected to maintain the quality of analgesia with a selective blockade of the nerves
      responsible for the sensitive innervation of the knee, reducing the total dose of local
      anesthetic and adrenaline very markedly.
    

Detailed description: 
      The main objective is to demonstrate that the ultrasound-guided geniculate nerve block
      provides not-inferior analgesia to LIA in patients undergoing primary total knee arthroplasty
      (TKA) in the first 24 hours postoperatively, and during the first mobilization using the
      numerical evaluation of the pain (NRS).

      The secondary objectives are to demonstrate that the consumption of opioids and the range of
      joint mobility are not inferior in those patients who receive geniculate nerve blocks
      compared to those who receive LIA.
    

Intervention name(s): Genicular nerve Block; Local Infiltration Analgesia
Intervention type(s): Procedure; Procedure
Intervention description(s): After the administration of spinal anesthesia, the anatomical structures of the proximal and distal region of the knee will be explored through an M- ultrasound machine Turbo® with a high-frequency 6-13 MHz linear probe.
The ultrasound transducer will be placed in a coronal orientation to the axis of the knee in the corresponding area to be blocked according to anatomical landmarks of superior medial genicular nerve (SMGN), inferior medial genicular nerve block (IMGN), superior lateral genicular nerve (SLGN), inferior lateral genicular nerve (ILGN), and recurrent genicular nerve (RGN).
It should be noted that the visualization of the genicular arteries in the femoral epicondyles and in the area of the tibial plateau, represents an accurate guide to where the sensory afferents are, however; its display is not constant.
4 ml of 0.2% ropivacaine will be administered, with adrenaline 1: 100 000 in each of the five nerves.; 100 ml of ropivacaine 0.2% with 1 mg of epinephrine during the period of intraoperative ischemia and, before the closure of the surgical wound, 50 ml of ropivacaine 0.2%.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Pain; Analgesia; LIA; Ultrasound; Genicular Nerve Block