cyrilzakka/clinical-trials huggingface dataset:
Prevalence of Hypoglycaemia in Congenital Adrenal Insufficiency

Children with congenital primary and secondary adrenal insufficiency, who are deficient in cortisol, are at risk for hypoglycaemia, irrespective of appropriate hydrocortisone treatment, which can lead to potentially serious neurological complications. Few series are described in pediatrics. The prevalence of hypoglycaemia is probably underestimated because it is often asymptomatic and capillary blood glucose monitoring is not always performed routinely.

The objective of the study is to evaluate the prevalence of hypoglycaemia in children with adrenal insufficiency.

Children with congenital primary and secondary adrenal insufficiency, who are deficient in cortisol, are at risk for hypoglycaemia, irrespective of appropriate hydrocortisone treatment, which can lead to potentially serious neurological complications. Few series are described in pediatrics. The prevalence of hypoglycaemia is underestimated because it is often asymptomatic and capillary blood glucose monitoring is not always performed routinely.

The objective of the study is to evaluate the prevalence of hypoglycaemia in children with congenital adrenal insufficiency.

The study will follow for one year children from 6 months to 6 years, with central and peripheral adrenal insufficiency.

4 study times are planned with two measurement methods:

* Continuous blood glucose measurement with Abbott Freestyle Pro for 14 days, repeated twice at 6 months intervals.
* Measurement of capillary blood glucose, in the morning on an empty stomach, every first week of each month for 12 months, with Abbott's Freestyle optium neo reader, used with the Accu-Chek FastClix lancing device and the test strips Accu-Chek performed.
* Measurement of capillary glycaemia in case of suspicion of hypoglycaemia. Measure left free according to the judgment of the parents of the necessary character or not. With Abbott's Freestyle optium neo reader, used with the Accu-Chek FastClix lancing device and the Accu-Chek performa strips.

Eligibility Criteria:
Inclusion Criteria:

* All male and female patients, followed in the Paediatric Endocrinology Department at Necker Hospital, with congenital primary and secondary adrenal insufficiency.
* Age between 6 months and 6 years.
* Included in the social security system.
* Parental consent and willingness to participate in this study: involves training and skills in the use of blood glucometers.

Exclusion Criteria:

* Patients with acquired adrenal insufficiency.
* Patients with type 1 or type 2 diabetes.
* Patients with somatotropic deficiency associated with adrenal insufficiency.
* Refusal or impossibility to perform the glycaemic measurements according to the procedure of the study.
* Not covered by the social security system.
Burden of Disease and Functional Impairment in XLH

Observational study comprising prospective follow up as well as retrospective chart review in order to evaluate the longitudinal course of the disease in XLH patients with a specific focus on functional impairment, physical performance and complications associated with the disease or respective treatment.

This is an observational / non-interventional study in order to assess the longitudinal course of XLH including disease related burden of disease and functional impairment. This is accomplished by both prospective follow up of affected patients as well as retrospective chart review. Evaluation conducted as per clincal routine and specifically evaluated as part of this study will include

* baseline documententation / demographic (as obtained from medical records)
* general data on XLH-disease specific medical history
* physical examination results
* functional assessments
* technical assessments
* quality of life / questionnaires
* laboratory evaluations

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged ≥ 18 years, inclusive, at the time of enrollment
* Diagnosis of X-linked Hypophosphatemia confirmed by

  * documented PHEX mutation in either the patient, or in a directly related family member
  * positive family history of XLH and symptoms of the disease or
  * Phosphaturia + elevated serum levels of c-term FGF23 or iFGF23 and symptoms of the disease
* Written informed consent

Exclusion Criteria:

- Suspected of confirmed diagnosis of another phosphate wasting disorder
Study of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma

The purpose of this clinical research study is to compare the best overall response rate (BORR)(as per modified WHO criteria) in patients with previously treated, therapy-refractory, or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg. The safety of this product will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma
Study of Axillary Skin Temperature as a Marker of Ovulation

Infertility is the most common reason women (aged 20-45yrs)see their GP, affecting 1 in 7 couples. Measuring basal body temperature is a technique that has been used since the 1930's to attempt to predict ovulation. Current NICE guidelines don't recommend the use of BBT charts to predict ovulation, as it has not been established to reliably confirm ovulation.

The DuoFertility sensor a CE marked Class la device provides a continuous accurate measure of axilla temperature whilst worn under the arm.

The investigators plan to compare the temperature measurements of the DuoFertility sensor with the gold standard transvaginal ultrasound scan obtained during 10 infertile women's menstrual cycles, up to 10 cycles per women.

The investigators aim to investigate if continuous axillary skin temperature measurement obtained from the DuoFertility sensor, provides comparable results for identifying the occurrence of ovulation as the gold standard transvaginal ultrasound scan.


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation
* Females aged 18 to 44 years.
* Referred with infertility to the Reproductive Medicine Clinic, Rosie Hospital
* Have a body mass index (BMI) above 19 and below 29
* Regular menstrual cycles, i.e. no greater than 7 days difference between the shortest and longest cycle in the last 6 months
* Minimum menstrual cycle 21 days
* Maximum menstrual cycle 35 days
* Willing to wear a DuoFertility sensor continuously for 8 to 10 menstrual cycles;
* Willing to attend Rosie Hospital up to 5 times per cycle for TVS and blood tests
* Willing to perform twice daily LH urine tests at home from day 8 of cycle till positive
* Normal pelvic ultrasound and blood results obtained during screening tests

Exclusion Criteria:

* Aged younger than 18 years, or older than 44 years
* Have a BMI less than 18 or greater than 29
* Any diagnosed systemic illnesses, including but not restricted to thyroid disease, diabetes or inflammatory diseases
* Polycystic ovary disease
* Endometriosis or other pelvic pathology (including proven tubal disease)
* Taking steroids, including oral contraceptives or anti inflammatory drugs
Quetiapine Sr as Adjunctive Treatment In Mixed States of Bipolar Disorder

To assess the acute and long-term bimodal efficacy of QTP, as an adjunct to ongoing treatment with lithium (Li) or divalproex (DIV) or lamotrigine (LAM) or any combination of the three thereof, in a group of patients with an index episode of a mixed state in BD.


Eligibility Criteria:
Inclusion Criteria:

* Male or female;
* Age 18 years and older
* Patients on:

  * Li at a stable dose for 4 weeks or longer, and a serum level at screening of 0.5 mEq/l OR
  * DIV dose for 4 weeks or longer, and a serum level at screening of 45 g/ml OR
  * LAM (dosage/day ≥100mg) at a stable dose for 4 weeks or longer OR
  * Any combination 3a, 3b, or 3c
* Patients meeting DSM-IV TR diagnosis of bipolar disorder, I or II, as assessed using the MINI, (Sheehan et al., 1998) PLUS any ONE of criteria 5 or 6 or 7
* Patients meeting DSM-IV TR diagnostic criteria for a mixed manic episode with Young Mania Rating Scale (YMRS) score\>/=14 and Montgomery Asberg Depression Rating Scale (MADRS) score\>/=14
* Patients meeting the criteria for a manic/hypomanic episode for at least 2 days with the simultaneous presence of Young Mania Rating Scale (YMRS) score\>/=14 PLUS Montgomery Asberg Depression Rating Scale (MADRS) score\>/=14 ;
* Patients meeting DSM-IV TR diagnostic criteria for a major depressive episode with the simultaneous presence of MADRS score\>/=14 PLUS meeting the criteria for a manic/hypomanic episode for at least 2 days with the simultaneous presence of Young Mania Rating Scale (YMRS) score\>/=14

Exclusion Criteria:

* Patients with a current Axis I diagnosis of schizophrenia, schizophreniform disorder, schizotypal disorder, bipolar disorder with psychotic subtype, drug induced mania or AIDS induced mania
* Women with a positive pregnancy test or who are lactating
* Women of child-bearing potential who are not practicing a clinically accepted method of contraception
* Patients with general medical conditions that contraindicate psychoactive medications or uncontrolled medical disorder or central nervous system diseases.
* Patients whose clinical status requires inpatient or day hospital treatment
* History of severe side effects associated with therapeutic doses of Li, DIV, LAM
* Alcohol or drug dependent at time of enrollment
* Suicidal at time of enrollment.
* Current or previous exposure to QTP
Dynamic 99mTc-Tetrofosmin CZT-SPECT Myocardial Perfusion Imaging in Comparison with Fractional Flow Reserve in Patients After Acute Coronary Syndrome

Dynamic 99mTc-Tetrofosmin CZT-SPECT myocardial perfusion imaging (MPI) is an advanced functional imaging technique giving important myocardial flow quantification added data in comparison with conventional MPI, especially in coronary multi vessel disease. A large-scale validation of diagnostic performances of myocardial flow reserve (MFR) estimated with Dynamic 99mTc-Tetrofosmin CZT-SPECT MPI would allow a non-invasive approach instead of invasive intra-coronary fractional flow reserve (FFR) measurement. The aim of this prospective study is to assess diagnostic performances of MFR calculated with dynamic 99mTc-Tetrofosmin CZT-SPECT MPI in comparison with invasive intra-coronary FFR measurement in patients with significant residual coronary arteries stenosis after acute coronary syndrome .


Eligibility Criteria:
Inclusion Criteria:

* Adult patient.
* Multi vessel coronary arteries disease (at least one non-culprit coronary stenosis \&gt;= 50%) diagnosis during

  * primary percutaneous coronary intervention \&lt; 12h after ST-elevation myocardial infarction opercutaneous revascularisation of the culprit lesion within 24 to 48 hours of an acute non-ST-segment elevation coronary syndrome.
* Written consent.
* Social security affiliation

Exclusion Criteria:

* Non adult patient.
* Adult patient under tutelage.
* Reproductive age women.
* Medical history of myocardial infarction or coronary artery bypass surgery.
* Cardiogenic shock.
* Cardiomyopathy.
* Regadenoson/adenosine/FFR contraindication.
* 99mTc-Tetrofosmin hypersensibility.
* Small non-culprit coronary arteries.
* Participation to another interventional study.
Impact of Periodontal Intervention on Vascular Dysfunction

The purpose of this study is to determine the effect of periodontal intervention on vascular dysfunction among Chinese prehypertensive adults with moderate to severe periodontal disease.

Periodontitis is one of the low-grade chronic diseases, and it is the principal cause of tooth loss among middle-aged and elderly. Recently, epidemiological data indicate that patients with periodontitis are associated with increases in blood pressure levels and hypertension prevalence. Furthermore, studies from cross-sectional investigations demonstrate that hypertensive patients with periodontitis may enhance the risk and degree of vascular damage. Therefore, periodontal therapy is a novel therapeutic strategy to prevent the occurrence of BP elevation and retard the development vascular injury.

The term "prehypertension" indicates those with BPs ranging from 120 to 139 mm Hg systolic and/or 80 to 89 mm Hg diastolic blood pressure. Accumulating evidence suggests that subjects with prehypertension is associated with higher incidence of atherosclerotic vascular disease. However, until now there are no available data to investigate the influence of periodontitis on prehypertension and whether periodontal intervention may reduce the BP rise in subjects with prehypertension and improve the vascular function. We hypothesized that periodontitis leads to elevation in BP and periodontal therapy improves vascular function in subjects with prehypertension. To address these assumptions, The present study is designed to study the effect of periodontal intervention on blood pressure and vascular function and inflammatory biomarkers among Chinese prehypertensive adults with moderate to severe periodontal disease, and determine whether intensive periodontal therapy improves these measures over a 6-month follow-up period.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be 18 years of age or older
2. Moderate to severe generalized periodontitis(probing pocket depths of \>6 mm and Marginal alveolar bone loss of \>30%) with 50% or more of their teeth affected
3. Have at least 16 natural teeth excluding third molars
4. BPs ranging from 120 to 139 mm Hg systolic and/or 80 to 89 mm Hg diastolic blood pressure
5. Provide informed consent and willingness to cooperate with the study protocol

Exclusion Criteria:

1. History of antibiotic use in the previous three months
2. Pregnant or lactating females
3. Systemic diseases such as diabetes, HIV/AIDS, liver disease, chronic renal failure, tuberculosis, and autoimmune diseases
4. Medical history of cardiovascular disease: Acute myocardial infarct, stable angina, unstable angina, heart failure, atrial fibrillation, atrioventricular blockade, peripheral vascular disease, cerebrovascular accident, hypertension
5. Patients who received periodontal treatment within the last 6 months
6. Patients who require antibiotic prophylaxis before examination or treatment
7. Patients with mental retardation and dementia
Postural Control Instability in Children With Mild Autism

Objective: Individuals diagnosed with Autism Spectrum Disorder (ASD) exhibit some type of motor control impairment, for instance, motor apraxia and history of gross motor delay that could lead to increased risk of fall. This pilot research was designed to assess and characterize static postural stability and create a starting point to better understand and describe postural control in children with mild autism. Method: We measured static postural control with center of pressure (COP) displacement in 10 children with mild autism during eight sensory conditions that challenge and cancel the visual, proprioceptive and vestibular systems.

Materials and methods Institutional Review Board (IRB) approval at the University of Puerto Rico, Medical Science Campus has obtained prior the recruitment of the participants. Parents of children diagnosed with mild ASD who were interested in the study called the number on the recruitment flyer. The PI spoke with the parent to assess whether their child qualified for the study based on the following inclusion and exclusion criteria.

Balance Assessment Protocol

The balance assessment procedure included the following; each subject was instructed to stand on both feet for 15 seconds on the pressure MatScan under eight different conditions. The first four conditions were executed over a stable surface and consisted of the following: (1) eyes open (EO) -evaluates visual, vestibular and proprioceptive systems, (2) eyes closed (EC) -eliminates visual input, evaluates vestibular and proprioceptive system, (3) eyes open while moving head up and down (at 60 beats per minute) (EO HUD) -evaluates visual and proprioceptive system and alters vestibular input, (4) eyes closed while moving the head up and down (EC HUD) -evaluates the effect of removing visual information, and the vestibular input being altered. The subjects then performed the same four tasks, this time standing on an unstable platform (high quality closed cell foam 19 inches long x 15 inches width x 2.25 inches)with the purpose of altering the proprioceptive input and increasing dependence on the visual and vestibular systems.

Eligibility Criteria:
Inclusion Criteria:

* children from 7-12 years of age, male or female
* mild ASD diagnosis (as determined by a medical doctor)
* capable of ambulating independently.

Exclusion Criteria:

* children with additional neurological problems
* children with visual problems
* children unable to tolerate walking or standing barefoot
* children who have fallen three or more times in the last three months
* children with vestibular problems.
In Vivo Real-time Detection of Circulating Melanoma Cells

The objective of this clinical trial is to determine whether a Photoacoustic flow cytometry (PAFC)-based prototype device can detect circulating tumor cells (CTCs) in the blood of melanoma patients in vivo, in real time, and do so at detection limits at least one order of magnitude below the detection limits of currently existing ex vivo methods.

Study Population: Approximately 80 subjects will be consented in order to achieve an enrollment goal of 75 subjects at this institution in three cohorts as follows:

1. Cohort #1 will consist of fifteen healthy control subjects, ten of whom will be Caucasian and five of whom will be African-American. Subjects in cohort #1 will be used to address the calibration goal of Specific Aim #1.
2. Cohort #2 will consist of 30 subjects who have advanced-stage melanoma will be recruited from the Medical Oncology clinic at UAMS, where advanced stages are defined as Stages III or IV. Subjects in cohort #2 will be used to address the validation goal of Specific Aim #2. Approximately half of the 30 advanced-stage subjects will be Stage III and the other half will be Stage IV.
3. Cohort #3 will consist of 30 subjects with early-stage melanoma will be recruited from the Surgical Oncology clinic at UAMS, where early stages are defined as Stages I or II.

Subjects in cohort #3 will be used to address the detection goal of Specific Aim #3. Approximately 10 of the 30 early-stage subjects will be Stage I and approximately 20 will be Stage II.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 80 years
* Histological documented diagnosis of melanoma
* Signed informed consent form approved by the University of Arkansas for Medical Sciences (UAMS) Institutional Review Board (IRB)
* Must be able to sit still for 90 minutes

Exclusion Criteria:

* Active infection
* Current and significant medical or surgical condition as determined by the Investigator
* Diagnosis or evidence of organic brain syndrome
* Pregnancy or breastfeeding
Exploring the Efficacy and Safety of Rivaroxaban to Support Elective Percutaneous Coronary Intervention

Balloon angioplasty (Percutaneous Coronary Intervention (PCI)) is commonly used to treat patients with obstructive coronary artery disease (CAD). Although PCI is highly effective for the management of CAD, it can potentiate an existing prothrombotic state around lesion areas. A certain level of anticoagulation is required to perform planned PCI safely and to minimize the periprocedural risk of thrombosis and its attendant complications, including myocardial ischemia and infarction (heart attack). Many different anti-thrombotic regimens have been investigated and are currently in use. The aim of this study is to explore whether Rivaroxaban, as compared to unfractionated heparin, on the background of standard dual antiplatelet therapy, can effectively suppress thrombosis and related adverse ischemic events, upon balloon inflation and stent expansion, during elective PCI, without increasing bleeding. The treatment assignment will be done in a semi-blinded design, eg, no blinding for randomization either to Rivaroxaban (one of the three arms) or the control (UFH) group. However, all will be blinded for the treatment dose of rivaroxaban (either 10mg or 20 mg).The 10 mg rivaroxaban plus 50 IU UFH arm will not be blinded.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subject aged 18 years or more with no upper age limit and willing to comply with the protocol
* Symptomatic coronary artery disease due to undergo an elective (non-emergent) Percutaneous Coronary Intervention (PCI) on one or two lesions in the native coronary vessel(s). Cardiac standard troponin at baseline is within the normal limits

Exclusion Criteria:

* Conditions that may increase the risk of the PCI procedure
* Conditions that may increase the risk of bleeding
* Significant valvular heart disease
* Calculated creatinine clearance ≤30 mL/min
* Current use of anticoagulant drugs including Vitamin K antagonist (VKA), factor IIa or factor XA inhibitors
* Chronic treatment with non-steroidal anti-inflammatory drugs (NSAIDs)
* Chronic treatment with aspirin \> 100mg
Efficacy of 0.12% Chlorhexidine Gluconate for Peri-implant Mucositis and Gingivitis

The purpose of this study is to analyze the efficacy of 0.12% chlorhexidine gluconate as a chemical adjuvant for the treatment of peri-implant mucositis in single implants compared with homologous teeth with gingivitis, in a non-surgical treatment protocol with a six-month follow-up.

The following clinical parameters were evaluated in both test and control groups; visible plaque index (VPI) and gingival bleeding index (GBI) were obtained for full mouth (IPV and ISG) and for each implant and teeth (VPI implant; VPI teeth; GBI implant; GBI teeth). For statistical purposes, percentages of faces with biofilm and marginal bleeding at teeth and implants were calculated. These parameters were evaluated at baseline and at one, three and six months post-therapy.

Probing depth (PD implant; PD teeth) and bleeding on probing (BOP implant; BOP teeth) were collected for all implants and teeth with a North Carolina periodontal probe at six sites. After data collection, an arithmetic averages of the sites with bleeding on probing and probing depths were calculated at baseline, three and six months. The peri-implant and periodontal biotype for each implant and teeth was rated as thin or thick, according to probe transparency during probing depth.

Eligibility Criteria:
Inclusion Criteria:

* Systemically-healthy partially edentulous patients rehabilitated with functional dental implants and prostheses for at least 1 year;
* Patients had been diagnosed with peri-implant mucositis, probing depth up to 5 mm, bleeding on probing and no radiographic evidence of bone loss beyond the first two threads of the implant;
* Patients had been diagnosed with gingivitis in homologous teeth to implants.

Exclusion Criteria:

* Non-smokers and not in maintenance therapy;
* Periodontal treatment during the last six months;
* Have not used antimicrobial (systemic or topical), anti-inflammatory or immunosuppressive drugs during the six months preceding the study.