cyrilzakka/clinical-trials huggingface dataset:
Glucose Variability in Pregnancy Complicated by Diabetes

Continuous glucose monitoring (CGM) methods provide details of magnitude and duration of glucose fluctuations, giving a unique insight on daily blood sugar control. Limited data are available on glucose variability (GV) in pregnancy. The aim of this study was to assess GV in normal pregnant women and cases of type 1 diabetes mellitus or gestational diabetes (GDM), and its possible association with HbA1c.

Recent evidence in the literature suggests that glucose variability, characterized by extreme glucose excursions, may overlap with HbA1c levels in determining the risk of diabetes-related complications. Fluctuating blood glucose levels prompt an increase in free radicals and endothelial dysfunction, which are the links between hyperglycemia and the activation of pathological pathways that lead to tissue damage. Reece and Homko postulated an association between maternal hyperglycemia-induced oxygen free radical overproduction and fetal abnormalities, with the onset of diabetes-related embryopathy.Numerous studies have demonstrated that macrosomia and congenital malformations relate to glycemic control. In one study, 48-hour continuous glucose monitoring (CGM) of diurnal glucose profiles in pregnant women with type 1 diabetes was more sensitive than HbA1c alone in identifying an increased risk of offspring with congenital malformations. Such studies give the impression that transient hyperglycemic spikes in pregnant patients with diabetes can cause a high incidence of fetal overweight, regardless of whether or not the mother has chronic hyperglycemia. Glucose variability is still a factor that has been inadequately studied in pregnancies complicated by diabetes, and little is known about its relationship with maternal-fetal outcomes.A number of studies have demonstrated the utility of CGM for monitoring diabetes in pregnancy , but none have focused the attention on the importance of glucose fluctuations during gestation. Meanwhile, there has been a rapid increase in the number of new glucose variability indicators considered, although none of them seems to be definitively reliable.

A better understanding of the pattern of blood glucose fluctuations in all the three trimesters of pregnancy, could help us to optimize glycemic control in pregnant women with diabetes.

The aim of this study was therefore to assess glucose variability throughout the three trimesters of pregnancy in healthy women and in cases of type 1 diabetes mellitus or gestational diabetes, identifying the more representative and useful indicators of glucose fluctuations, to provide more accurate clinical informations along with HbA1c and beyond.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of type 1 diabetes or GDM
* able to become familiar with glucose monitoring methodologies

Exclusion Criteria:

* type 2 diabetes
* pre-gestational BMI \> 35 Kg/m2
* HbA1c \> 8% for type 1 diabetic pregnant women
Comparative Validation of the Triptorelin Test for the Diagnosis of CPP in Girls

The aim of the study is to determine the specificity, sensitivity and diagnostic efficiency of the Triptorelin Test in the assessment of CPP compared to GnRH test as gold standard.

Hypothesis: Aqueous Triptorelin Acetate is so efficient as GnRH to CPP assessment.

Study population are girls with suspicious clinical features of precocious puberty

GnRH stimulation is the gold standard to distinguish between isolated premature thelarche (PT) and CPP. However, intravenous GnRH for testing is not fully available in all countries. To evaluate the diagnostic accuracy of a novel Triptorelin-test in the assessment of CPP compared to the GnRH test, a validation study was performed. Girls who presented thelarche with accelerated growth and/or advanced bone age were included. All girls underwent the two tests in a randomized order. CPP was ascertained according to LH response under GnRH (gold standard test).

Eligibility Criteria:
Inclusion Criteria:

* premature thelarche and/or
* accelerated growth velocity (above 90 percentile)
* advanced bone age at least 1.5 year in relation to chronological age.

Exclusion Criteria:

* contact with sources of exogenous estrogens in the last four months previous to evaluation,
* suspicion of peripheral precocious puberty,
* previous central nervous system illness or suspicion of organic central precocious puberty.
Comparison of the Success Rate of Two Approaches for Obturator Nerve Block in TURB (Conventional Pubic Approach [Labat Technique] and Inguinal Approach)

The purpose of this study is to compare the success rate of two approaches for obturator nerve block in TURB (conventional pubic approach \[Labat technique\] and inguinal approach.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergoing transurethral resection of bladder tumor during combined spinal anesthesia and obturator nerve block were included in the clinical study

Exclusion Criteria:

* Patients with advanced cardiac and respiratory insufficiency
* Allergy to local anesthetics
* Preexisting neurologic deficits
* Prior operation involving the hip and the inguinal region and bleeding tendency were excluded.
Chronic VEnous dIsorders maNagement and Treatment effectivenesS evaluaTion in Chronic vEnous Disease, an International Program

The primary objective of this study is to assess in real-life settings the effectiveness of conservative treatments on symptoms, signs and quality of life, in patients consulting for CVD


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old
* Patient consulting spontaneously or referred for symptomatic venous disorders
* Diagnosis of chronic venous disease according to investigator's judgment

Exclusion Criteria:

* Presence of known severe systemic disease likely to interfere with the study evaluation
* Patients with lower limb arterial disease
* Patient with any other concomitant disease or treatment that may interfere with lower limb pain or edema
* Patient consulting for an emergency not related to venous disease
* Patient currently taking any treatment for chronic venous disorders, either with venoactive drug or with compression hosiery
* Procedure or surgery for venous disease planned during the study
* Pregnant or breastfeeding woman
The Association of Fast Food Densities With Mortality From Cardiovascular Disease

In this cross sectional study, county level data for CVD and stroke mortality, and prevalence of T2D, were combined with per capita densities of FFR and FSR and analysed using multiple and simple linear regression. Mortality and diabetes prevalence were corrected for poverty, ethnicity, education, physical inactivity and smoking to reduce confounding effects.

the investigators used data on mortality rate (per 100,000 individuals) for CVD and stroke (between 2011 and 2013, age\>35years) from the publicly available Centers for disease prevention and control (CDC) web site (www.cdc.gov). CVD mortality was defined as the number of deaths per 100,000 person-years due to circulatory causes (International Statistical Classification of Diseases, Tenth Revision, codes I00-I99). Detailed information on preparation, definition, download and sorting of data on prevalence of T2D (age-adjusted), poverty and ethnicity have been explained elsewhere. In brief, county level data on the prevalence of T2D were downloaded from the USA CDC web site (www.cdc.gov). Data on T2D was estimated using data from the CDC Behavioural Risk Factor Surveillance System (BRFSS) which is a monthly state based telephone survey of a nationally representative sample of adults aged \>20 years old. In 2012, the year for which these data were downloaded, the survey included landline telephones only and hence excluded individuals living in care homes or those without a landline telephone. More than 400,000 individuals are contacted annually to take part in the survey which has been running since 1984. Individuals are judged to have diabetes if they respond 'yes;' to the question "Has a doctor ever told participants that you have diabetes?", excluding females who indicate in a follow-up question that they only had diabetes during pregnancy. Previous work indicates that self-report of a physician's prior diagnosis of diabetes is highly reliable compared to medical records. This question does not separate those with type 1 and T2D. In the adult population of the USA more than 96% of diabetes is type 2, the investigators therefore called the estimated prevalence that of T2D. Given the magnitudes of the trends described here they cannot be attributed to differences in prevalence of the type 1 diabetes. Data on rate of mortality (per 100,000 individuals) from CVD and stroke (between 2011 and 2013, age\>35years) were also downloaded from CDC web site (www.cdc.gov, National Vital Statistics System and National Centre for Health Statistics). A previous variogram analysis has established that counties are an appropriate spatial level at which to explore the associations of factors to T2D prevalence.

Eligibility Criteria:
Inclusion Criteria:

1. age\>35 years

Exclusion Criteria:

None

-
ArtemiCoffee in Patients With Rising PSA

Until now, clinicians have been challenged to improve the treatment of biochemically recurrent (BCR) prostate cancer in which prostatic specific antigen (PSA) rises without radiological or clinical progression years after localized treatment (radical prostatectomy or radiation therapy) with or without hormonal treatment. Approximately 50-90% of men with high-risk prostate cancer will experience a BCR. Artesunate has demonstrated anti-tumor activity in both in vivo and in vitro cell lines. It is hypothesized that Artemisia annua (Aa) coffee has the potential to decrease rising PSA among patients with biochemical recurrence of prostate cancer.

This is an open-labeled phase II study of Artemisia annua (Aa) decaf coffee in patients with biochemical recurrence of prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* Completion of localized therapy (prostatectomy or radiotherapy) for prostate adenocarcinoma (either histologically or cytologically confirmed)
* Biochemical PSA recurrence
* Age ≥18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤3
* Total bilirubin ≤ 1.5 x upper normal limit (ULN), and AST (aspartate transaminase) and ALT (alanine transaminase) ≤ 3.0 x ULN
* Patients with a prior or concurrent malignancy (non-prostate) whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen as determined by the treating physician are eligible.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Any radiological evidence of metastatic disease (determined by standard of care computed tomography (CT) scans of abdomen, pelvis, chest, whole body bone scan or Axium PET/CT scan or prostate specific membrane antigen (PSMA) PET/CT scan).
* Receipt of prior cytotoxic chemotherapy for recurrent prostate cancer
* Use of androgen deprivation therapy (for example, bicalutamide, flutamide, nilutamide, or leuprolide acetate) concurrently or within the previous 3 months.
* Uncontrolled intercurrent illness such as active infections. Other illnesses will be evaluated and eligibility status determined at the discretion of the treating physician and the investigator.
* Psychiatric illness/social situations that would limit compliance with study requirements.
* Concomitant use of nevirapine, ritonavir, and strong UGT inducers or strong UGT inhibitors such as phenobarbital, rifampin, carbamazepine, diclofenac, imatinib, axitinib, and vandetanib
* Concurrent use of strong inducers of CYP2A6, including phenobarbital and rifampin
The Effects of Lower Extremity Sensory Retraining Treatment in Individuals With Post-stroke Sensory Impairment

Background: It is estimated that 50%-85% of individuals post stroke demonstrate sensory deficits. Sensory impairments are often overlooked in the therapeutic setting, although they lead to slower motor recovery.

Working hypothesis: The overall goal of this study is to examine the effectiveness of a sensory discrimination reeducation oriented therapeutic program to the lower limb of stroke patients with sensory impairments. We assume that subjects to both groups will make progress, which will be more significant in the experimental group.

Methods: Study population and design: Sixty individuals with chronic sensory impairment following a stroke will be recruited. Patients will be randomly assigned to sensory retraining treatment or to sensory stimulation treatment. Treatment will consist of ten 45 minute long intervention sessions, carried out within a 6 weeks period, and a home exercise program. The person conducting the assessments will be blind to the treatment allocation of the subjects. Outcome measures: The efficacy of the intervention will be determined in relation to the International Classification of Functionality (ICF) developed by the World Health Organization and will include assessments at the three domains defined by this model: 1. Body structure and function - determined by measures of the sensory capacity of the lower more affected limb; 2. Activities - determined by measures of balance and gait; 3. Participation - determined by measures of well-being and social reintegration.

Two new outcome measures, for ankle and knee position sense and for texture discrimination of the foot, will be developed within this study. Data reliability measures on healthy population, and test - retest measures in post stroke population with be collected.

Intervention: The experimental group will be treated by a perception learning oriented protocol for sensory reeducation, to improve identification, localization and discrimination of sensory stimuli, including electrical stimulation, texture and hardness discrimination and position sense training. The control group will receive the same stimuli without the attentive learning and discriminating component.

Importance: Scientific proof and focused recommendations for a potent therapeutic method for the post-stroke population, allowing them better participation and quality of life.

Key words: Stroke, sensory impairment, perceptual learning, lower limb, clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* post stroke
* at least 6 months after stroke
* with sensory deficits in study's screening tests

Exclusion Criteria:

* other neurologic condition
* peripheral neuropathy
* pacemaker
* hemispatial neglect
Vitamin D, Insulin Resistance and Inflammation in ESRD

The broad goal of this study is to understand the mechanisms by which Vitamin D receptor activation leads to changes in insulin signaling in advanced uremia. We hypothesize that 1,25-Dihydroxyvitamin D3 deficiency due to advanced chronic kidney disease leads to insulin resistance and that administration of a vitamin D3 analog will restore insulin sensitivity in End Stage Renal Disease patients.


Eligibility Criteria:
Inclusion Criteria:

* CKD and receiving hemodialysis for ≥ 3months
* Kt/V ≥ 1.2
* ≥ 18 years of age
* Medically stable
* AVF or PTFE dialysis access
* No acute inflammatory disease within 4 weeks prior to the study
* On stable dose of Paricalcitol for 4 weeks prior to the study
* iPTH value between 150 - 1500 within the past 3 months
* Ca \< 10.5
* PO4 \< 10

Exclusion Criteria:

* Pregnancy
* Intolerance to the study medication
* Severe, unstable, active, or chronic inflammatory disease (active infection, active connective tissue disorder, active cancer, HIV, liver disease)
* Type 1 Diabetes mellitus
* Uncontrolled Type 2 Diabetes mellitus (HbA1c \> 10)
* Hospitalization within 1 month prior to the study
* Malfunctioning arterial-venous vascular access (recirculation and/or blood flow \< 250 ml/min)
* Presence of hemodialysis catheter
* Patients receiving steroids and/or other immunosuppressive agents (\> 10 mg prednisone qd)
* BMI \< 25 and \> 45
Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis

This phase 2 trial will evaluate the effects of EP547 in subjects with cholestatic pruritus due to Primary Biliary Cholangitis (PBC) or Primary Sclerosing Cholangitis (PSC)


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 80 years
* Documented primary biliary cholangitis (PBC) or primary sclerosing cholangitis (PSC)
* Presence of consistent moderate to severe pruritus
* Use of anti-pruritic and anti-cholestatic (including UDCA and obeticholic acid) medication allowed if meeting additional criteria
* Individuals with concomitant inflammatory bowel disease must meet additional relevant criteria

Exclusion Criteria:

* Pruritus associated with an etiology other than PBC or PSC
* Prior or planned liver transplantation
* Evidence of compensated or decompensated cirrhosis
* Alternative causes of liver disease
* Presence of documented secondary sclerosing cholangitis
* Current evidence of clinically significant high-grade strictures or presence of biliary stent
* History of significant small bowel resection or short bowel syndrome
* Has exclusionary laboratory or biochemical results at Screening
Opinions of Healthcare Providers About Neuromodulation

The goal of this online survey is to gain further insight in the goals, expectations and definition of success for neuromodulation for pain, according to healthcare providers.


Eligibility Criteria:
Inclusion Criteria:

- Male and female adults who are involved in the management of chronic pain and more specifically in neuromodulation for pain (including but not limited to anesthesiologists, neurosurgeons, nurses).

Exclusion Criteria:

- Not involved in management of chronic pain through neuromodulation.
The Association Between Physical Symptoms and Depression Among Medical Students in Egypt

To examine the association between depression and physical symptoms among medical students in Egypt.

The Google Form will be open for one week from the start of the academic term. It is divided into three parts:

Demographic Data - which includes age, academic level, relationship status, and whether the student intends to work while studying.

Patient Health Questionnaire PHQ-9: Assesses symptoms of poor mental health in the two weeks prior to the start of term.

Patient Health Questionnaire PHQ-15: This is a measure of physical symptoms felt in the week prior to the commencement of the academic term.

The questionnaire will be distributed among different medical faculties in Egypt and all students will be required to fill it out. Data analysis will be done through SPSS to explore the relationship between psychological and physical symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Medical students enrolled in any medical program in Egypt.
* Age range: Typically 19 to 30 years (or based on your study's demographic focus).
* Willingness to participate and provide informed consent.
* Self-reported symptoms of depression: Those who indicate moderate to severe symptoms on screening tools (e.g., PHQ-9).
* Physical symptoms: Those who report experiencing physical symptoms (e.g., headaches, fatigue, gastrointestinal discomfort, etc.) on a checklist.

Exclusion Criteria:

* Non-medical students (students outside of the medical program).
* Students with a history of major medical conditions that may confound the physical symptoms (e.g., chronic diseases like diabetes, hypertension, or neurological disorders).
* Students with a diagnosed psychiatric disorder (e.g., bipolar disorder, schizophrenia, etc.) or those already undergoing psychiatric treatment.
* Non-consenting individuals: Students who decline to participate in the study or do not provide informed consent.
* Incomplete responses: Students who fail to provide adequate or valid responses in the questionnaires.
Comparison Between Symbicort® and Prednisolone in COPD

To assess if Symbicort forte Turbuhaler (during two weeks) is as effective as an oral course of prednisolone + Oxis Turbuhaler (during two weeks) for the treatment of an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD).


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic obstructive pulmonary disease and an acute exacerbation
* After the acute treatment a simple pulmonary function test shows a value of 30%-60% of the predicted normal value.
* Patients, who, based on the clinical examination after the initial acute treatment, are candidates for a course of oral steroids for the treatment of acute symptoms due to chronic obstructive pulmonary disease

Exclusion Criteria:

* Diagnosis/history of asthma
* Oxygen uptake (saturation) is \<92% after the initial acute treatment
* A requirement for regular use of oxygen therapy
* Regular treatment with any inhaled steroid \>1 000 µg/day at study entry

Additional inclusion and exclusion criteria will be evaluated by the investigator
Efficacy and Safety of Mexartan Potassium Tablets (AZL-M) and Calcium Channel Blockers (CCB) in the Treatment of Adults With Essential Hypertension in Chinese Population: a National Multicenter, Prospective, Observational Study

This is a national multicenter, prospective, observational study. It is planned to enroll 1215 patients with newly diagnosed essential hypertension in 80 centers, and divide them into 3 groups according to different treatment plans given by doctors: AZL-M monotherapy group, CCB monotherapy group (amlodipine besylate tablets or nifedipine controlled-release tablets) and AZL-M+CCB (amlodipine besylate tablets or nifedipine controlled-release tablets) combined treatment group. Subjects were visited 4 times at baseline, 1 month, 3 months, and 6 months, and the following key indicators of subjects were measured according to the doctor's decision, and the measurement results were collected


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old (one year old);
2. Patients diagnosed with essential hypertension;
3. Did not receive any antihypertensive drug treatment for at least 3 months before enrollment;
4. Eligible to use 80 mg once-daily AZL-M at baseline or CCB (amlodipine besylate tablets or nifedipine controlled-release tablets) or CCB (besylate Amlodipine tablets or nifedipine controlled-release tablets) + AZL-M 80 mg once-daily combination therapy; Volunteer to participate in this study, understand and sign the written informed consent.

Exclusion Criteria:

1. Used antihypertensive drugs for indications other than hypertension within 3 months before enrollment;
2. Has a history of alcoholism, drug abuse or illegal drug use;
3. Pregnant, breastfeeding women, and those who plan to become pregnant in the near future;
4. Life expectancy is less than one year; Participating in other clinical trials.
Hyperpolarized 129Xe MRI Lung Health Cohort

A subset of young adults participating in the American Lung Association (ALA) Lung Health Cohort (LHC) will be imaged using Hyperpolarized 129Xe MRI to assess lung structure and function. Images will be used to improve the understanding of lung health and early lung abnormalities that may lead to chronic lung disease.


Eligibility Criteria:
Inclusion Criteria:

* Is enrolled in the American Lung Association Lung Health Cohort Study.
* Has completed CT imaging for the LHC study within 2 years of the scheduled Xe-MRI date.

Exclusion Criteria:

* Pacemaker, internal defibrillator or other implanted electronic devices or any standard MRI contraindications (e.g., claustrophobia, \> 140 cm shoulder circumference, dependent on weight distribution).
* Is pregnant or breastfeeding
* Oxygen saturation (SpO2) \<88% on room air or with supplemental oxygen.