cyrilzakka/clinical-trials huggingface dataset:
Empagliflozin and Red Blood Cell 2,3-biphosphoglycerate Levels

The aim of this study is to investigate the hypothesis that treatment with empagliflozin may have an impact on red blood cell 2,3-biphosphoglycerate levels affecting tissue oxygen supply and thus mediating part of the cardio- and reno- protective effect of SGLT-2 inhibitors.


Eligibility Criteria:
Inclusion Criteria:

Patients\>18 year-old and at least one of the following

* Type 2 Diabetes Mellitus and HbA1c: 6.5-9.0% or HbA1c \<6.5% and history of Coronary Artery Disease or Stroke not treated with GLP-1RA
* Heart Failure defined as Ejection Fraction\<40% or NT-proBNP\>300pg/ml or Atrial fibrillation and NT-proBNP\>900pg/ml
* Chronic Kidney Disease defined as eGFR\<60ml/min/1.73m2 (CKPD- EPI) or/and UACR\>200mg/g Initiating treatment with empagliflozin 10mg once daily as add on treatment

Exclusion Criteria:

* Patients already treated with an SGLT-2 inhibitor
* Patients with Hb\<11gr/dl or\>16gr/dl
* Patients with history of inherited or acquired hemoglobin disease
* Patients with history of hemolytic anemia
* Patients with history of hematologic malignancy or myelodysplastic syndrome or myeloproliferative syndrome
* Patients treated within the last 6 months for anemia due to iron, B12 or folate deficiency
* Patients with history of major hemorrhage or major operation leading to RBC transfusion within the last 3 months.
* Patients planning major operation or revascularization procedure within the 12 following weeks
* Patients treated with erythropoietin
* Patients with Chronic Kidney Disease and GFR\<30ml/min/1.73m2
* Pregnancy
* Women of childbearing age not receiving appropriate contraception measures
Cardiovascular Consequences of Intermittent Hypoxia in Healthy Subjects

The study is a prospective field evaluation to assess the effects of the chronic Intermittent Hypoxia exposure in 12 healthy humans.

Precisely, the study was designed to :

Set up a new model of Chronic Intermittent Hypoxia (CIH) applied to healthy human. This CIH is mimicking the CIH undergone by patients suffering from Sleep Apnea Syndrome.

Evaluate the cardiovascular effect of CIH. Neuronal and humoral sympathetic control, blood pressure control, vascular resistance.

Evaluate the Sleep quality, the ventilation under exposure and the long terms effect on ventilation control of CIH (central and peripheral chemoreflex).

Investigates the biological aspects of CIH exposure.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* Any history or significant medical condition
Non-compliance on Treatment Among Diabetic Students at Sohag University

A cross-sectional study on diabetic students in Sohag University will be conducted to collect data about factors affecting compliance and adherence to diabetes treatment and its impact on development of complications.

Personal interviews with diabetic students through a questionnaire :

1. To determine factors affecting non compliance on treatment among diabetic students.
2. To detect relation between non compliance on treatment and development of complications.

Eligibility Criteria:
Inclusion Criteria:

* Diabetic students at Sohag University age from 17 to 25

Exclusion Criteria:

* Healthy students
* Students in other universities
Ph2 Open-label Study of AOC 1044 in Duchenne Muscular Dystrophy Participants with Mutations Amenable to Exon44 Skipping

AOC 1044-CS2 (EXPLORE44-OLE) is an Open-label Study to Evaluate the Pharmacodynamics and Long-Term Safety and Tolerability of AOC 1044 Administered Intravenously to DMD Participants with Mutations Amenable to Exon 44 Skipping.

AOC 1044-CS2 (EXPLORE44-OLE) is an open label, extension study to Part B of AOC 1044-CS1 (EXPLORE44). AOC 1044-CS2 is designed to evaluate the pharmacodynamic effect of AOC 1044 on dystrophin protein production in skeletal muscle as well as the long-term safety, tolerability, pharmacokinetics, and exploratory efficacy of AOC 1044.

All participants who enroll in AOC 1044-CS2 will receive active treatment. The treatment period is 2 years with IV dosing every 6 or 8 weeks.

Once participants have completed active treatment, they will be followed through a 3-month safety follow-up period. The sponsor may extend active treatment beyond 2 years at a future timepoint.

Eligibility Criteria:
Key Inclusion Criteria

Rollover Participants:

* Satisfactorily completed AOC 1044-CS1 (EXPLORE44) as determined by the Investigator and Sponsor
* No significant tolerability issues with AOC 1044

De novo Participants:

* Aged 7 to 27 years, inclusive, at the time of informed consent
* Clinical diagnosis of DMD or clear onset of DMD symptoms at or before the age of 6 years
* Confirmation of DMD gene mutation amenable to exon 44 skipping
* Weight ≥ 23 kg
* Ambulatory or non-ambulatory

  * Ambulatory participants: LVEF ≥50% and FVC≥50%
  * Non-ambulatory participants: LVEF ≥45% and FVC≥40%
* PUL 2.0 entry item A ≥3
* If on corticosteroids, stable dose for 30 days before screening and throughout the study

Key Exclusion Criteria

Rollover Participants:

* Presence of any new condition or worsening of existing condition that could affect a participant\&#39;s safety or ability to comply with study procedures

De novo Participants:

* Serum hemoglobin \&lt; lower limit of normal
* Uncontrolled hypertension or diabetes
* Prior treatment with any cell or gene therapy
* Prior treatment with another exon 44 skipping agent within 6 months prior to informed consent
* Recently treated with an investigational drug
* History of multiple drug allergies
CPAP in SAHS Patients With Hypertension

Study objective: To assess the nocturnal changes in mechanosensitivity and chemosensitivity in hypertensive sleep apnea-hypopnea syndrome (SAHS) patients and in SAHS patients with isolated nocturnal hypertension. To value the continuous positive airway pressure (CPAP) effect on these parameters.

Design: Controlled cross-over longitudinal study. Settings: Madrid metropolitan area. Patients: Day-night sustained hypertensive and isolated nocturnal hypertensive patients with SAHS without previous treatment. At least 30 patients are needed.

Interventions: Patients will allocate in each treatment arm (CPAP vs. sham CPAP) during three months. Explorations will perform before and immediately after sleep at 0-, 3-, and 6-months of trial.

Measurements: 24-h urinary catecholamine, local vascular factors, angiotensin and aldosterone levels. Diaphragmatic tension-time index, metabolic rate, hypoxic withdrawal test, and ventilatory and inspiratory neural drive responses to progressive isocapnic hypoxia.


Eligibility Criteria:
Inclusion Criteria:

* Recent diagnosis of sleep apnea-hypopnea syndrome with an apnea-hypopnea index (AHI) \> 10 h-1
* No previous treatment for SAHS or hypertension
* Diagnosis by 24-h ambulatory monitoring of blood pressure (AMBP) of isolated nocturnal hypertension (nighttime blood pressure of ≥120 mm Hg systolic or 70 mm Hg diastolic and a daytime blood pressure \<135/85 mm Hg) or day-night sustained hypertension (nighttime blood pressure of ≥120 mm Hg or 70 mm Hg diastolic and a daytime blood pressure of ≥135 mm Hg systolic).

Exclusion Criteria:

* Severe hypertension (\> 180/120 mmHg).
* Previous diagnosis of secondary hypertension.
* Myocardial infarction or stroke in the last three months.
* Severe diurnal sleepiness (Epworth score \> 15)
* Previous diagnosis of chronic obstructive pulmonary disease, asthma, bronchiectasis, lung cancer, restrictive lung disease, chest wall disease or thoracic surgery.
* Previous diagnosis or clinical evidence of heart disease, neuromuscular disease or thyroid dysfunction.
* Morbid obesity (BMI \> 40 Kg/m2)
* Respiratory infection in the last two months.
* Treatment with theophylline or systemic corticosteroids in the last two years.
* Excessive alcohol intake (\>40 g/day)
* Absence of social or familiar support.
Sulforaphane in a New Jersey (NJ) Population of Individuals With Autism

This study is a double blind treatment trial that will test if sulforaphane improves core symptoms in autism. The investigators expect to see clinical improvement in some of these areas. Sulforaphanes come from eating certain vegetables such as broccoli. The investigators will be using a preparation that gives specific and reproducible amounts. The investigators will also test specific chemicals and genes needed for sulforaphane usage to try to understand differences in response.

This study is a double blind randomized treatment trial that will test if sulforaphane improves core symptoms in autism. It is designed to try to replicate a previous trial (ClinicalTrials.gov Identifier NCT01474993) which reported that the isothiocyanate, sulforaphane treatment led to improvement by multiple metrics. Significant improvement was seen in behavior as measured by the Aberrant Behavioral Checklist (ABC) and by the Social Responsiveness Scale (SRS). In addition a significantly greater number of participants receiving sulforaphane had improvement in social interaction, abnormal behavior, and verbal communication as per the Clinical Global Impression (CGI). In addition The investigators will attempt to account for some variability in response to sulforaphane treatment by testing alleles of genes that are relevant in sulforaphane metabolism. The investigators will also measure glutathione levels, which are also important in sulforaphane metabolism and are in part regulated by sulforaphane..

Sulforaphane is the most potent naturally occurring inducer of mammalian cytoprotective enzymes known. Therapeutic potential is based at least in part on their ability to up-regulate genes responsible for alleviation of oxidative stress and to regulate both the immune system and the inflammatory response

40 Males with autistic disorder will be randomly selected to receive either sulforaphane or placebo. Seven visits are required by the subjects including enrollment ,screening, baseline, weeks 4, 10 and 18 and a follow up visit at seek 22.

Eligibility Criteria:
Inclusion Criteria:

* Autistic disorder diagnosis.
* Age between 13-30 years.
* Male gender.

Exclusion Criteria:

* Absence of a parent or legal guardian and consent,
* Those that can not or will not complete all visits and adherence to study regimen.
* Seizure within 2 years of screening,
* Impaired renal function (serum creatinine\> 1.2 mg/dl).
* Impaired hepatic function (\> 2x upper limit of normal).
* Impaired thyroid function (TSH outside normal limits).
* Current infection or treatment with antibiotics.
* Chronic medical disorder (e.g., cardiovascular disease, stroke or diabetes) or major surgery within 3 months prior to enrollment.
* Less than 13 years or more than 30 years of age.
* Female gender.
* A diagnosis of autism spectrum disorder other than autistic disorder, for example, Asperger, Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) etc.
Evaluation of Efficacy and Tolerability of Hizentra®

The purpose of this study is to measure the changes in the Treatment Satisfaction Questionnaire for Medication in the areas of effectiveness, side effects, and convenience of administration of each medication in Primary Immunodeficiency Disorder (PIDD) subjects transitioning from subcutaneous Vivaglobin® to Hizentra®.

This trial will evaluate subjects with Primary Immunodeficiency Disorder (PIDD) who are currently self-infusing Vivaglobin therapy for at least six months prior to changing to Hizentra® therapy. Following screening and enrollment, subjects will continue to self-infuse Vivaglobin® for seven infusions and then be converted to subcutaneous Hizentra® treatment which they will continue for the next 6 months. The study will determine if Hizentra® provides improved subject satisfaction by Treatment Satisfaction Questionnaire for Medication. Diaries related to the local site reactions, the number of infusion sites per subject/per dose, volume of Hizentra® per site, duration of infusions, systemic side effects of the new medication and dose on IgG levels and antibody titers, and local site reactions with Hizentra®.

Eligibility Criteria:
Inclusion Criteria:

* Subjects currently self-infusing with Vivaglobin® for at least six months prior to enrollment.
* Diagnosis of antibody deficiency due to primary immune deficiency disease.
* Stable serum IgG levels of \> 550 mg/dl while on Vivaglobin® based on two determinations at least 8 weeks apart and obtained within 6 months of entry.
* Willing to sign consent and follow study schedule.
* 1 year to 75 years of age.

Exclusion Criteria:

* Evidence of acute systemic illness or infection at within four weeks of screening or enrollment.
* Any serious grade 3 or greater toxicity at screening.
* History of bleeding or chronic skin disorders.
* Selective IgA deficiency in absence of other antibody deficiencies
* History of anaphylactic or severe systemic reaction to Vivaglobin.
* Pregnant or breastfeeding females.
* Use of systemic pre-medication prior to SCIG.
* Protein losing enteropathy or nephritic syndrome.
* Any condition that in the opinion of the investigator would interfere with the conduct of the study.
* Subject or guardian unwilling to sign consent or adhere to study schedule.
Gel-200 Extension and Open-Label Study in Osteoarthritis of the Knee

The purpose of this study is to determine if a single or repeat intra-articular injection of Gel-200 is safe and effective in subjects with symptomatic osteoarthritis of the knee and to determine if original SI-6606/01 Gel-200 therapy is durable beyond the original study.


Eligibility Criteria:
Inclusion Criteria:

* Previous participation in study SI-6606/01.

Exclusion Criteria:

* Female subjects who are pregnant or lactating.
Genetic Polymorphisms and Their Association With Temporomandibular Disorders

Temporomandibular disorders (TMD) are the most common orofacial pain disorders of non-dental origin with the prevalence of 6.1-10.2%, and incidence of 3.9%. Observable pathology is mostly absent, and the etiology often remains unknown. Since some other painful conditions of unknown origin (eg. fibromyalgia), also imply genetic factors, the aim of the study is to investigate genetic predisposition in relation to the risk for TMD onset. This will be achieved through analysis of polymorphisms in the selected genes in TMD patients (DC/TMD) and matched control subjects. The possibility of involvement of specific polymorphisms in modulation of therapy response will also be investigated. The hypotheses: (I) the Single Nucleotide Polymorphism (SNPs) clustering will be dependent on presence or absence of TMD (comparison of patients with control subjects), and will possibly depend on source of pain, pain intensity, presence of bone changes, psychological features and previous orthodontic therapy, and (II) SNPs will influence the treatment response. Along with anamnestic and clinical examination and occlusal splint therapy, genomic DNA will be analyzed from the buccal swabs. Isolated DNA will be used for the determination of 19 polymorphisms of selected genes using Real-Time PCR method. The analysis of salivary oxidative stress markers and opiorphin will be also performed, as their relationship with TMD has been shown previously. This time, their concentration will be associated with polymorphisms in the promoters of genes responsible for their synthesis. The investigators expect to show that particular gene profile or group of SNPs represent a risk factor for TMD development. Innovative approach of the concept of determining the genetic predisposition for TMD has the potential for development of commercial genetic test with potential for risk estimation in relation to TMD onset. This could enable early interventions and active avoidance of environmental risk factors.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of myofascial pain / arthralgia / painful disc displacement according to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
* average pain in the last 10 days \>30 mm on a Visual Analogue Scale
* pain duration of at least 3 months
* good oral hygiene
* presence of own natural teeth
* absence of any form of chronic pain in the orofacial region or in other regions of the body

Exclusion Criteria:

* other orofacial pain conditions including dental pain
* poor oral hygiene, gingivitis or periodontitis
* chronic medical conditions (diabetes, cardiovascular diseases, cancer, and autoimmune diseases) - - -
* neurological and psychiatric disorders
* pregnancy
* causes of headache, unrelated to TMD, listed in the International Classification of Headache Disorders
Efficacay of Chloroquine or Hydroxychloroquine in COVID-19 Treatment

Chloroquine or hydroxychloroquine in COVID-19 treatment

Clinical Study Evaluating the Efficacy of Chloroquine or hydroxychloroquine in COVID-19 treatment

Eligibility Criteria:
Inclusion Criteria:

* Covid 19 patients

Exclusion Criteria:

* Allergy or contraindication to the drug
* Pregnant or lactating
* Patients with cardiac problems
Preferences About Personal Protective Equipment

Personal protective equipment (PPE) gained importance during the Coronavirus Disease 2019 (COVID-19) pandemic, which is a global hot topic for all healthcare staff.

To assess children and parents preferences about dentists' appearance concerning their PPE and to determine the relationship between the preferences of the children and their parents.

A total of 250 children aged with 6-12 years and their parents were enrolled in the study. Standardised pictures with different sex, attire, eye protector, hair protector, mask and gloves were shown to children and their parents separately and asked to chose their preferences. Dental anxiety of children and their parents were determined with MCDASf and MDAS, respectively. Decayed-missing-filled teeth (DMFT) index was employed to the children.

Eligibility Criteria:
Inclusion Criteria:

* aged 6-12 years and their parents,
* intellectually sufficient to complete the questionnaire,
* with voluntariness to take part in the study

Exclusion Criteria:

* had mental or physical disorders, cooperation problems or dental pain
The Effect of Granulocyte Colony Stimulating Factor Versus Human Chorionic Gonadotropin in Females With a History of RIF

One hundred patients who suffered from recurrent implantation failure in intracytoplasmic sperm injection (ICSI) were allocated in the study. On ovum pick-up day, 50 of them were intrauterine injected with granulocyte colony-stimulating factor (G-CSF) and the other 50 were injected with intrauterine Human Chorionic Gonadotropins (HCG). The clinical pregnancy rate was evaluated as a primary outcome and ultrasound imaging of the gestational sac was evaluated as a secondary outcome

One hundred patients suffering from recurrent implantation failure in intracytoplasmic sperm injection (ICSI) were included in the study. The patients were randomly allocated into two groups. The intervention group consisted of 50 patients who received intrauterine injected with granulocyte colony-stimulating factor (G-CSF). The other group (the control group) consisted of 50 patients and injected with intrauterine Human Chorionic Gonadotropins (HCG). Both groups received the interventions at ovum pick-up day. The main outcome was the clinical pregnancy rate which has been evaluated after 2 weeks of the positive pregnancy test. The secondary outcome was an ultrasound image of the gestational sac after 6 weeks of pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Females suffering from recurrent implantation failure and undergoing ICSI

Exclusion Criteria:

* presence of comorbidity as diabetes, hypertension, heart diseases, or endocrine disorders
Prospective Registration and Assessment of Serious Adverse Events Within the AFNET

Prospective registration and independent assessment of SAE associated with atrial fibrillation such as thromboembolic events, and other cardiac and noncardiac complications by a Critical Event Committee.

Atrial fibrillation (AF), the most common sustained rhythm disturbance, is associated with a significantly enhanced mortality and morbidity due to thromboembolic events, and other cardiac and noncardiac complications. Therefore the "Network of Competence on Atrial Fibrillation (AFNET)" supported by the German Ministry for Education and Research (BMBF) was established in order to collect clinical data on patients (pts) with AF (paroxysmal, persistent, permanent) over a study period of 6 years with an expected sample size of 12,000 pts. Incidence, clinical relevance and outcome after SAE is recorded and assessed by a Critical Event Committee (CEC).

The CEC-members (experts in cardiology and neurology) defined as SAE any death with or without relationship to AF, cardio-embolic events (stroke, peripheral arterial embolism), bleeding complications due to antithrombotic therapy, acute heart failure, syncope, resuscitation; additionally, the complication of interventional strategies for AF-treatment and other AF-independent SAEs.

Over a 3-year follow-up period, during 6-monthly and unscheduled visits, the SAEs are systematically documented, blinded and their relationship to AF will be interpreted in detail by the CEC.

Eligibility Criteria:
Inclusion Criteria:

* Atrial fibrillation documented by ECG not older then one year
* Age \> 18 years
* Informed consent

Exclusion Criteria:

* none
Early Detection and Post-operative Monitoring of Gastric Cancer

This study is to determine the performance of non-invasive new multi-target biomarkers in the early detection and post-operative monitoring of gastric cancer.

This study aims to develop and validate a new non-invasive detection method for early detection and postoperative monitoring of gastric cancer in the blood. Sensitivity, specificity, accuracy, ROC curve area, positive predictive value, and negative predictive value of the new biomarkers in the diagnosis of gastric cancer will be compared with that of tumor biomarkers CA19-9, CEA, and CA72-4. Blood will also be collected at various time points post-operatively. The investigators will determine whether these new biomarkers can be used as prognostic biomarkers to predict tumor recurrence and metastasis. The investigators will also determine whether these new biomarkers detect tumor recurrence and metastasis earlier than methods currently used in the clinic such as imaging and tumor biomarkers CA19-9, CEA, and CA72-4.

This study is a prospective and multi-center study.

Eligibility Criteria:
Inclusion Criteria:

1. Subject age over 18.
2. Subject has stomach discomfort, and seek medical attention at the Gastric Surgery Department of our center.
3. Subject has or will have gastroscopy and/or pathological examination results at this center.
4. Subject must be able to fully understand the informed consent form and be able to personally sign it.

Exclusion Criteria:

1. Subject has serious heart, liver, kidney dysfunction, or mental illness.
2. Subject diagnosed previously with any kind of malignant tumor.
3. Subject is known to be infected with HIV or other related diseases (considering interference from the use of immune drugs).
4. Subject is receiving targeted drugs, immunosuppressants, immunomodulators, and biological therapies.
5. Researchers believe that subject is not suitable for enrollment.
6. Subject can not supply sufficient sample to complete this experiment.