cyrilzakka/clinical-trials huggingface dataset:
Renal Effects of DPP-4 Inhibitor Linagliptin in Type 2 Diabetes

The aim of this study is to detail the (mechanisms underlying the) actions of the DPP-4 inhibitor linagliptin on the renal system in patients with type 2 diabetes mellitus.

Based on preclinical and small-sized studies in non-diabetic individuals, incretin-based therapies, i.e. glucagon-like peptide (GLP)-1 receptor agonists and dipeptidyl peptidase-4 inhibitors (DPP-4i), may hold promise in preventing the onset and progression of diabetic kidney disease. However, the potential renoprotective effects of these agents, that are believed to be effectuated "beyond glucose control", have not been sufficiently detailed in human diabetes.

Therefore, the present study aims to explore the mechanistic and clinical effects of DPP-4i on fasting and postprandial renal physiology and biomarkers in patients with type 2 diabetes.

Forty-eight patients with type 2 diabetes will undergo an eight week intervention with linagliptin or glimepiride in order to assess changes in the outcome parameters.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes (HbA1c: 6.5-9.0% DCCT or 48-75 mmol/mol IFCC)
* Metformin monotherapy; using a stable dose for at least 3 months prior to inclusion
* Both genders (females must be post-menopausal)
* Caucasian
* Age: 35-75 years
* Body Mass Index: \>25 kg/m2
* All patients with previously diagnosed hypertension should use a RAS-interfering agent (angiotensin converting enzyme inhibitor/angiotensin II receptor blocker) for at least 3 months

Exclusion Criteria:

* Current / chronic use of the following medication: thiazolidinediones, insulin, glucocorticoids, immune suppressants, antimicrobial agents or chemotherapeutics. Subjects on diuretics will only be excluded when these drugs (e.g. hydrochlorothiazide) cannot be stopped for the duration of the study
* Chronic use of NSAIDs will not be allowed, unless used as incidental medication (1-2 tablets) for non-chronic indications. However, no such drugs can be taken within a time-frame of 2 weeks prior to renal-testing
* Pregnancy
* Frequent occurrence of (confirmed) hypoglycemia (plasma glucose \<3.9 mmol/L)
* Estimated Glomerular Filtration Rate \< 60 mL/min/1.73m2 (determined by the Modification of Diet in Renal Disease (MDRD) study equation)
* Current urinary tract infection and active nephritis
* Recent (\<6 months) history of cardiovascular disease, including: acute coronary syndrome, chronic heart failure (New York Heart Association grade II-IV), stroke, transient ischemic neurologic disorder
* Complaints compatible with or established gastroparesis and/or neurogenic bladder
* Active liver disease
* History of or actual pancreatic disease
* History of or actual malignancy (except for basal cell carcinoma)
* History of or actual severe mental disease
* Substance abuse (alcohol: defined as \>4 units/day; smoking/nicotine: defined as daily smoking/use)
* Allergy to any of the agents used in the study
* Inability to understand the study protocol or give informed consent
Postprandial Lipid Metabolism in Patients With Hypertriglyceridemia and Normo-lipidemic Controls: Medium Chain Fatty Acids (MCT) in Comparison to Long-chain, Saturated Fatty Acids (SFA) and Mono-unsaturated Fatty Acids (MUFA)

Postprandial lipid metabolism will be evaluated in patients with hypertriglyceridemia and normo-lipidemic controls; different fats will be used (saturated fatty acids, mon-unsaturated fatty acids and medium chain fatty acids) for the oral fat challenge.


Eligibility Criteria:
Inclusion Criteria:

* hypertriglyceridemia (150 mg/dl-900 mg/dl)

Exclusion Criteria:

* Lipid lowering drugs or indication for Lipid lowering drugs
* LDL-cholesterol \> 190 mg/dl
* Diabetes mellitus
IPF Italian Observational Study (FIBRONET) in Idiopathic Pulmonary Fibrosis

The purpose of the present study is to evaluate the characteristics, management and clinical course of patients with IPF as treated under real-world in Italian Pulmonary Centres, in terms of symptoms, lung function and exercise tolerance during 12 months of observation.


Eligibility Criteria:
Inclusion criteria:

1. Patients aged\>=40 years
2. Written informed consent to both participation in the study and privacy
3. Physician diagnosed IPF during the last 3 months based upon recent American Thoracic Society/European Resp. Society/Japanese Resp. Society/Latin American Thoracic Association guidelines 2011 (see Tables A1-A2 for High Resolution Chest Computer Tomography and histology criteria):

   * Exclusion of other known causes of Interstitial Lung Disease (e.g. domestic and occupational environmental exposures, connective tissue disease and drug toxicity)
   * Assessment of Idiopathic Pulmonary Fibrosis based on High Resolution Computed Tomography (HRCT) or HRCT and surgical lung biopsy if available.
4. Patient with further follow-up possible with enrolling investigator during planned study period
5. Patients capable of discernment and able to read or write in Italian language.

Exclusion criteria:

1. Inclusion in clinical trials or other IPF/ILD registries
2. Lung transplantation expected within the next 6 months
3. Pregnancy or breast feeding
Treatment of PRP on Diabetes Wound

The purpose of this study is to focus on the effect of platelet-rich-plasma on diabtic ulcer foot, as adjuvant treatment along with the standard care of chronic diabetic, and evaluate the efficiency and the clinical application of PRP on serious wound healing.

Diabetes is a condition in which the body dose not effectively use sugar so that there is too much sugar in the blood. It is estimated that 15% of the diabetics suffer from diabetic food ulcers at some point. The healing process can be slow and easily to be infected with some pathogens so the patients are at risk in amputation. The wound healing process is a complex mechanism involves the interaction of molecular signals and different cell types. Platelets play important roles in wound healing. When injury occurs platelets are activated with thrombin and clot is formed. In addition to the function of hemostasis, activated platelets release many growth factors that trigger angiogenesis, extracellular matrix production and cytokine release, which is need for wound healing.

Platelet-rich plasma (PRP) is a portion of plasma fraction of autologous blood having a high concentration of thrombocytes. Thrombin induces the activation of PRP and results in the release of multiple growth factors, including platelet-derived growth factor (PDGF), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), insulin-like growth factor (IGF), and transforming growth factor beta (TGF-β). PRP is known for the capacity to stimulate cell proliferation and differentiation. PRP can also interact with macrophage to improve tissue healing and regeneration, and exhibit potent activities against several kinds of pathogens.

Our study will focus on the advantage of PRP for aiding wound healing for diabetes. PRP from autologous blood can be mixed with thrombin in appropriate ratio and inject into the sites around the wound, as adjuvant treatment along with the standard care of chronic diabetic. The wound will be checked 1 to 2 times each week for the evaluation of PRP on clinical application.

Eligibility Criteria:
Inclusion Criteria:

* diabetic patient who suffers from sereious alcer feet.
* age of 20-70 years old

Exclusion Criteria:

* patient with systemic disorder
* psycho
* patient with coagulation abnormality
* patient with inflammation
Aurinia Renal Response in Active Lupus With Voclosporin

The purpose of this study is to assess the efficacy of voclosporin compared with placebo in achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis.

The aim of the current study is to investigate whether voclosporin, added to the standard of care treatment in active lupus nephritis (LN), is able to reduce disease activity over a treatment period of 52 weeks. The background therapy will be mycophenolate mofetil (MMF) and initial treatment with IV methylprednisolone, followed by a reducing course of oral corticosteroids. Subjects with active, flaring LN will be eligible to enter the study. They are required to have a diagnosis of LN according to established diagnostic criteria and clinical and biopsy features suggestive of active nephritis. Efficacy will be assessed by the ability of the drug combination to reduce the level of proteinuria (as measured by Urine Protein Creatinine Ratio (UPCR)) while demonstrating an acceptable safety profile.

Eligibility Criteria:
Key Inclusion Criteria:

- Subjects with evidence of active nephritis, defined as follows:

* Kidney biopsy result within 2 years prior to screening indicating Class III, IV-S, IV-G (alone or in combination with Class V), or Class V LN with a doubling or greater increase of UPCR within the last 6 months to a minimum of ≥1.5 mg/mg for Class III/IV or to a minimum of ≥2 mg/mg for Class V at screening. Biopsy results over 6 months prior to screening must be reviewed with a medical monitor to confirm eligibility.

OR

* Kidney biopsy result within 6 months prior to screening indicating Class III, IV-S or IV-G (alone or in combination with Class V) LN with a UPCR of ≥1.5 mg/mg at screening.

OR

* Kidney biopsy result within 6 months prior to screening indicating Class V LN and a UPCR of ≥2 mg/mg at screening.

  * Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline.

Exclusion Criteria:

* Estimated glomerular filtration rate (eGFR) of ≤45 mL/minute at screening.
* Current or medical history of:

  * Congenital or acquired immunodeficiency.
  * In the opinion of the Investigator, clinically significant drug or alcohol abuse within 2 years prior to screening.
  * Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision.
  * Lymphoproliferative disease or previous total lymphoid irradiation.
  * Severe viral infection or known HIV infection.
  * Active tuberculosis (TB), or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid.
* Other known clinically significant active medical conditions, such as:

  * Severe cardiovascular disease, liver dysfunction or chronic obstructive pulmonary disease or asthma requiring oral steroids or any other overlapping autoimmune condition for which the condition or the treatment of the condition may affect the study assessments or outcomes.
Local Analgesia to Prevent Pain in Patient Undergoing Removal of the Uterus Through Vaginal Route

Following a hysterectomy, women tend to experience high levels of pain, and many require strong pain killers after the procedure. Ropivacaine is a local anaesthetic drug (injectable numbing medication) which works by blocking pain signals. The aim of this study is to find out whether injections of ropivacaine during surgery can help provide effective pain relief after surgery.Women aged between 45 and 70 who are having a vaginal hysterectomy can participate in the trial. Participants are randomly allocated to one of two groups. Those in the first group are given injections of ropivacaine at the site of the wound and in the peritoneum (space in the body that holds the organs in the abdomen) and those in the second group are given injections of a saline fluid in the same places that offers no pain relief before the end of their surgery. Participants in both groups are then regularly asked to rate their pain levels up to 24 hours after surgery. In addition, the pain killers they receive and length of hospital stay are recorded. There is a chance that the participants who receive the ropivacaine will benefit from lower pain levels after surgery. There are no notable risks of participating.

At end of the vaginal hysterectomy operation, the gynecologist will inject the uterosacral, cardinal ligaments, adnexal areas and the vaginal edge with 15 ml of either the ropivacaine solution or the placebo fluid in each side, then 20 ml will be instilled inside the peritoneum. Analgesia will be given on request after operation. Visual analogue score of 0 to 100 mm will be used to assess the degree of pain, with 0 indicating no pain and 100 indicating worst pain.

Eligibility Criteria:
Inclusion Criteria:

1. Female
2. 45 to 70 years old
3. Scheduled for NDVH (non descent vaginal hysterectomy) for benign indications without need for oophorectomy or vaginal reconstructive surgery

Exclusion Criteria:

1. Patient weight less than 50 kg
2. Allergy to amide local anesthetic
3. Dementia or mental retardation to a degree which would interfere with data collection
4. Contraindication to non descent vaginal hysterectomy
A Double-Blind, Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 in Hereditary Angioedema Participants

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) profile of multiple subcutaneous administrations of DX-2930 across a range of doses in HAE participants.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age at the time of screening
* Documented diagnosis of HAE (Type I or II)
* Experiencing ≥2 HAE attacks per year, with at least 1 attack in the past 6 months reported by the participant
* Willing and able to read, understand, and sign an informed consent form
* Females of childbearing potential must agree to be abstinent or else use acceptable forms of contraception throughout study
* Males with female partners of childbearing potential must agree to be abstinent or use a medically acceptable form of contraception throughout study

Exclusion Criteria:

* Exposure to an investigational drug or device within 90 days prior to study
* History of exposure within the past 5 years to a monoclonal antibody or recombinant protein bearing an Fc domain
* Concomitant diagnosis of another form of chronic angioedema
* Use of long-term prophylaxis for HAE within 90 days prior to study
* Use of C1-INH that exceeds a total of 30 days within the past 90 days prior to study; any use of C1-INH within 7 days prior to study
* Exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications with systemic absorption within 90 days prior to study
* Exposure to androgens within 90 days prior to study
* Presence of an indwelling catheter
* Diagnosis of HIV
* Active liver disease or liver function test abnormalities
* History of substance abuse or dependence
* Pregnancy or breastfeeding
* Any condition that, in the opinion of the Investigator, may compromise their safety or compliance, preclude successful conduct of the study, or interfere with interpretation of the results
Natural Orifice Specimen Extraction in Sigmoid Volvulus

Sigmoid resection can be performed using conventional and laparoscopic methods. There are few publications in the literature reporting specimen removal from the natural hole in patients with a diagnosis of sigmoid volvulus. Here, the investigators aimed to present the literature that transanal specimen removal is a technically feasible method after laparoscopic surgery in patients with sigmoid volvulus.

Sigmoid resection can be performed using conventional and laparoscopic methods. There are few publications in the literature reporting specimen removal from the natural hole in patients with a diagnosis of sigmoid volvulus. Here, the investigators aimed to present the literature that transanal specimen removal is a technically feasible method after laparoscopic surgery in patients with sigmoid volvulus. The documents of patients who were operated on for sigmoid volvulus between 2018 and 2019 were retrospectively reviewed. Patients who had been used transanal for specimen extraction by elective laparoscopic sigmoid colon resection were included in the study. Patients' gender, age, comorbidity, operation time, operative difficulties, complications, length of stay, and mortality findings were analyzed. Laparoscopic sigmoid resection and transanal specimen removal were performed in eight patients. Specimen extraction surgery from the natural hole is increasingly preferred. the investigators think that natural hole surgery can be performed more easily and reliably in sigmoid volvulus due to the large diameter of the colon.

Eligibility Criteria:
Inclusion Criteria:

* transanal for specimen extraction by elective laparoscopic sigmoid colon resection

Exclusion Criteria:

* emergency surgery
* conventional open sigmoid resection
* conventional laparoscopic sigmoid resection
Relationship Between Post-Intubation Tracheal Stenosis and Covid-19

Tracheal stenosis (TS) is a serious complication that occurs in approximately 6-22% of patients due to prolonged endotracheal intubation. Cuff hyperinflation of the endotracheal tube, use of large tubes, advanced age, female gender, smoking, obesity, and diabetes are risk factors for TS. The most common and serious complication in COVID-19 patients is acute respiratory distress syndrome (ARDS), which requires oxygen and ventilation treatments. In the literature, it is reported that 9.8-15.2% of patients need invasive mechanical ventilation (IMV). The concern of aerosol formation and prone position applications that emerged with the coronavirus pandemic caused delays in tracheostomy decisions and the use of uncontrolled high cuff pressures, paving the way for TS. The capillary perfusion pressure of the tracheal mucosa ranges from 20 to 30 mmHg. A cuff pressure of the endotracheal tube above 30 mmHg causes mucosal ischemia. Cartilage inflammation due to ischemic injury may be partial or full thickness. Depending on the degree of inflammation in the affected tracheal segments, stenosis and even perforation may develop.

It is aimed to determine the etiological causes, to determine how much of the total TS cases covid-related TS constitutes, to examine the treatments and patient results in covid/non-covid TS.

This study will contribute to the measures that can be taken during and after the care process in the intensive care unit.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years

Exclusion Criteria:

* Patients undergoing surgical procedures for malignancy
Effect of Intravenous Lidocaine on BIS-guided Propofol Requirements During General Anesthesia

The purpose of this randomized clinical trial is to evaluate the interaction of lidocaine infusion initiated and maintained during surgery, on propofol requirements during general anesthesia.

Use of intravenous lidocaine as a coadjuvant agent during general anesthesia has increased. Lidocaine infusion during and after abdominal surgery decreases postoperative pain and reduces ileus duration, reducing patient´s hospital stay and opioid consumption. Intravenous lidocaine´s effect on other intravenous anesthetics is unclear, and there are no present studies evaluating its interaction on hypnotic anesthetic requirements when using a BIS (Bispectral Index) monitor to maintain an adequate depth of anesthesia. We therefore decided to conduct a randomized controlled trial to evaluate the interaction of systemic lidocaine infusion, initiated and maintained during surgery, on propofol requirements and anesthetic depth as measured by BIS.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II patients,
* Between 20 and 65 years of age
* Programed for elective laparoscopic cholecystectomy
* Eligible for total intravenous anesthesia with propofol

Exclusion Criteria:

* Unwillingness to participate in the study
* Adverse reactions to the drugs used in the study
* Use of medications that interfere in local anesthetic metabolism
* History of liver disease, kidney failure, hypoalbuminemia, hypocalcemia or hypophosphatemia
* History of drug or alcohol abuse
* Chronic use of benzodiazepines
Sleep Patterns in Children and Adolescents With ADHD

This study is aimed to find out Sleep profile differences in children and adolescents with and without ADHD,Relationship between sleep profile disturbance and ADHD symptoms, Impact of sleep disturbance on cognition functions and quality of life.

Attention deficit hyperactivity disorder (ADHD) is the most common neurodevelopmental disorder of childhood, affecting 3 -5% children \& adolescent worldwide . Inattention, hyperactivity, and impulsiveness are the major ADHD symptoms based on the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM), Fifth Edition .

Sleep has been referred to as a "window to the central nervous system", owing to its close associations with many other neurophysiological variables. Children are highly vulnerable to sleep disruptions in early childhood, perhaps due to the complexity of the sleep process and children's reliance on caregivers for achieving and maintaining sleep .

The relationship between sleep and ADHD is a complex process and has gained renewed interest since clinicians and researchers observed that sleep-related problems and complaints are relatively common among children with ADHD .Previous studies have shown that About 25-50% of children and adolescents with ADHD have sleep disorders , including nocturnal awakenings, phase delay, increased night time activity and insomnia.

Evaluation of sleep problems in child \&adolescent clinical settings is commonly lacking, often unrecognized and go untreated in clinical setting. So, Untreated sleep disturbances and sleep disorders pose significant adverse daytime consequences and place children at considerable risk for poor health outcomes . Sleep disturbances impair a child's cognitive functioning and contribute to problems with school attendance and performance .

Eligibility Criteria:
Inclusion Criteria:

* Ages 6-17 years inclusive
* males or females
* Intelligence Quotient( IQ) \> or equal 80 detected by Wechsler Intelligence Scale for Children .
* Willingness to comply with all study requirements

Inclusion criteria for ADHD group only:

• confirmed newly diagnosed ADHD according to DSM-5 Criteria. (American Psychiatric Association)

Exclusion Criteria:

* History of chronic/significant medical condition
* History or Current prescribed use of any psychotropics, including non-stimulant medications for ADHD.
* History or Current substance abuse or dependence.
* First degree relative with psychosis or bipolar disorder.

Exclusion for the ADHD group only:

• Meets criteria for any other psychiatric comorbidity Disorder besides ADHD or Oppositional Defiant Disorder (ODD).

Exclusion for the Healthy Control group only:

• Meets criteria for any psychiatric Disorders.