cyrilzakka/clinical-trials huggingface dataset:
The Effects of Potassium on Physiological and Cardiovascular Variables in Healthy Persons

In humans living of fruit and vegetables, hypertension is rarely seen. We wish to study if the development of hypertension has a connection to our intake of potassium. We know that fruit and vegetables contain a lot of potassium and we will simulate this intake by giving healthy subjects potassium as tablets.


Eligibility Criteria:
Inclusion Criteria:

* healthy
* age 18-40 years old
* BMI 18, 5-30
* non-smoker

Exclusion Criteria:

* daily use of medicine
* alcohol or drugs
* desire to become pregnant
* not using safe anti-contraceptive
* abnormal results in the initial testing
Safety and Immunogenicity of 20vPnC in Toddlers With 2 Prior Doses of Prevenar 13

The purpose of this study is to understand the safety and effects of a study vaccine (20vPnC) in toddlers who had 2 prior doses of Prevnar 13.

This study is being conducted in children who:

* are between 12 to 23 months of age;
* are healthy as determined by the study doctors;
* have received 2 doses of Prevnar 13 during the first year in life.

Participants in this study will receive either 1 dose or 2 doses of the study vaccine or 1 dose of Prevnar 13 as a shot in the muscle. During the study, participants will have to come to the study clinic to receive the vaccines and have blood sample collected. The study team will work with participants' parents or legal guardians to monitor any unwanted reactions to the vaccines. Participants are expected to take part in this study for about 1 or 3 months, for 1 dose or 2 dose schedules, respectively.


Eligibility Criteria:
Inclusion Criteria:

* Male or female toddlers ≥12 to \<24 months of age at the time of consent
* Healthy toddlers determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study
* 2 infant doses of Prevenar 13 prior to 12 months of age

Exclusion Criteria:

* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)
* Major known congenital malformation or serious chronic disorder
* Other chronic medical or laboratory abnormality that may increase the risk associated with study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Previous vaccination with any investigational pneumococcal vaccine, or planned receipt through study participation
Effect of Genetic Polymorphisms on Response to Beta Blocker Therapy in Egyptian Patients

Beta-blockers represent a cornerstone for the treatment of coronary artery disease (CAD). Their protective effect is based on the negative inotropic and chronotropic features, which have been tested in a large number of randomized controlled trials, both in patients with myocardial infarction (MI) and in those with stable angina, demonstrating a reduction of adverse cardiovascular events, a relief of symptoms and a reduction of myocardial ischemia

However, considerable interpatient variability in response to β-blockers has been reported which indicates that a considerable proportion of β-blocker-treated patients do not achieve the warranted cardio protection with β- blockers. This highlights the importance of identifying biomarkers associated with variability in response to β-blockers to improve the current approach for β- blocker selection, which seems to be suboptimal.

This study aims to study the effect of polymorphism in adrenergic beta receptors on beta-blocker response in Egyptian patients.


Eligibility Criteria:
Inclusion Criteria:

1. Beta-blockers naïve patients
2. Patients been on beta-blocker therapy for at least 4 weeks.
3. Age (18-75) Years old.

Exclusion Criteria:

1. Non-Egyptians.
2. Kidney failure of any stage.
3. Liver failure of any stage.
4. Malignancy.
5. Pregnancy.
6. HR \< 55 beats/min (in the absence of b-blocker therapy).
7. Presence of a cardiac pacemaker.
Soy Isoflavone in Combination With Radiation Therapy and Cisplatin in SCC of the Head and Neck

The purpose of this study is to determine if soy supplementation during chemotherapy and radiation therapy will decrease side effects caused by treatment. Long-lasting dry mouth is a side effect of the standard treatment, and we are testing whether soy supplementation during treatment may reduce this symptom and other side effects of chemoradiation.

Concurrent chemoradiation is the standard of care for locally advanced squamous cell carcinoma of the head and neck (SCCHN). Improving the outcome for patients with this disease remains a major challenge.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven squamous cell carcinoma of the head and neck (SCCHN)
* Primary disease site involving the oropharynx
* Clinical stage III or IV
* Age ≥ 18
* Karnofsky Performance Status (KPS) ≥ 70
* Adequate bone marrow, kidney, and hepatic function (no laboratory value \> 2 times the normal limit)
* Amylase (0-160 U/L) and lipase (0-130 U/L) levels within 1.5 times the range of normal

Exclusion Criteria:

* Prior history of SCCHN
* Prior history of radiation to the head and neck region
* KPS \< 70
* Soy allergy
* Contraindication to cisplatin chemotherapy or plans to alter or reduce cisplatin therapy
* Any head and neck cancer of non-squamous histology
* Any head and neck subsite other than oropharynx (including unknown primary site)
* Patients who are pregnant or lactating
* Patients who may benefit from surgical resection
Dupilumab Efficacy on Bronchial Inflammation, Small Airways Disfunction and Mucous Secretion

Unicentric prospective real life study designed to analyse the efficacy of Dupilumab to reduce bronchial inflammation of asthma measured by inflammatory cell counts obtained in induced sputum and other related characteristics (small airway dysfunction and mucin production) in uncontrolled severe asthma patients in the real life setting without control group

After patients signed informed consent, before (visit 1), after 4-5 months (visit 2), and after 12 months (visit 3) Dupilumab treatment began, the following techniques and measurements will be performed or collected: demographic data, blood analyses (eosinophil counts and total IgE), skin prick-test to common aeroallergens (only in the visit 1), asthma control test (ACT), sino-nasal outcome test (SNOT-22), test of adherence to inhalers (TAI), number of severe asthma exacerbations (in the previous year; in the visit 2, in the previous 4 months), oral and inhaled steroid daily doses received, spirometry, exhaled nitric oxide (FeNO), pulmonary volumes, carbon monoxide transference, oscillometry, and induced sputum (inflammatory cell counts and mucin profile \[MUC1, MUC2, MUC5AC, MUC5B\]). All patients will be performed at visits 1 and 3 in a 3D culture of primary nasal epithelial cells from asthmatic patients the pattern of gene and to identify new soluble biomarkers through quantitative proteomic analysis of culture supernatants.

Also a chest CT scan with expiratory images will be done only in visits 1 and 3.

Eligibility Criteria:
Inclusion Criteria:

* 18 -80 years
* Severe uncontrolled eosinophilic asthma by GINA (Global Initiative for Asthma) criteria
* Clinical indication of Dupilumab

Exclusion Criteria:

* Smoking over 10 pack/year
* Treatment with monoclonal antibodies treatment during the previous three months
* Refuse to sign informed consent
Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine for Cleft Palate

To compare the efficacy of the pre-operative nebulization of a combination of dexmedetomidine and ketamine versus nebulization of dexmedetomidine alone for sedation and prevention of emergence delirium in children undergoing cleft palate repair surgeries.

Cleft palate is a common congenital anomaly. The American cleft palate-craniofacial Association recommends that primary cleft palate repair should be ideally performed between 12-18 months after birth.

The pre-operative period is quite distressing for children due to parental separation, application of face mask for induction of anaesthesia, fear of needles and unfamiliar faces. Pre-operative Anxiety is associated with adverse outcomes via elevation of stress markers, promoting fluctuations in hemodynamic, and negatively impacting postoperative recovery. There is a growing interest in the use of dexmedetomidine, a highly selective alpha-2 adrenergic agonist, for paediatric premedication. Ketamine may attenuate dexmedetomidine-induced bradycardia and hypotension and accelerate the onset of sedation with no respiratory depression.

Eligibility Criteria:
Inclusion Criteria:

* Patients with American Society of Anesthesiologists (ASA) physical status I \& II who will be scheduled for cleft palate repair surgeries

Exclusion Criteria:

* Parent refusal
* Allergy to the study drugs
* Suspected difficult airway
* Patients with endocrine, renal, hepatic, and cardiac pathology
* Psychiatric diseases
* Asthmatic patients.
Bryophyllum vs. Nifedipine

In a prospective, randomised study the efficacy and tolerability of bryophyllum p. (p.o) vs. nifedipine (p.o) will be proofed in a defined group of pregnant women with threatened preterm labour.


Eligibility Criteria:
Inclusion Criteria:

* Female

Exclusion Criteria:

* Bishop Score \> 5
Evaluation of the Adherence and the Patient Acceptability of Zomacton® Treatment With the Zomajet® Vision X Device

The study is performed to collect long-term data on the treatment adherence and patient's acceptability when Zomacton®10 mg is administered with the Zomajet® Vision X device in patients with a growth hormone deficiency or Turner's syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Patient with growth hormone deficiency,

  1. Diagnosis of growth hormone deficiency proven by appropriate exploration
  2. Size ≤ -2 Standard Deviation (SD) according to the French references
  3. Growth velocity in the previous year inferior to the normal for age (-1SD) or \< 4cm/year
* Growth deficiency due to Turner's syndrome

  1. Turner's syndrome confirmed by a karyotype
  2. Patient's size ≤ -2 SD according to the French references
  3. Bone age \< 12 years
* Patient who require a minimum of 18 months of treatment.

Exclusion Criteria:

* There are no exclusion criteria except the contraindication for Zomacton® 10 mg
Multi-Ethnic Study of Atherosclerosis (MESA) - Ancillary Eye Study

To evaluate the relation of retinal microvascular characteristics to subclinical cardiovascular disease, clinical disease, and their risk factors in the Multi-Ethnic Study of Atherosclerosis (MESA) cohort.

BACKGROUND:

The study further expands and enlarges the findings of the NHLBI-supported Atherosclerosis Risk in Communities (ARIC) study on the relationship of retinal microvascular disease to the presence of subclinical and clinical cardiovascular disease among Multi-Ethnic Study of Atherosclerosis (MESA) participants. ARIC data showed that retinal microvascular changes were associated with the following findings: markers of persistent hypertensive damage, markers of inflammation and endothelial dysfunction, magnetic resonance imaging (MRI)-detected cerebral infarct independent of hypertension, predictive of 3-year incident stroke independent of hypertension, and predictive of 3-year incident coronary heart disease in women but not men.

DESIGN NARRATIVE:

The MESA-EYE study is a separate add-on to the Multi-Ethnic Study of Atherosclerosis, a six regional center 10 year program begun in July 2000. The overall goals of the parent study are the identification of risk factors for subclinical cardiovascular disease, for progression of subclinical disease, and for transition of subclinical to clinical cardiovascular disease. The eye component will tie in with Exam 2 of the main study which begins August 2002 and runs through January 2004. Retinal photography to document microvascular changes will be performed on the approximately 6,500 MESA participants at Exam 2. Retinal photography will follow a standardized written protocol similar to that used in ARIC. Focal arterial narrowing and AV nicking will be classified as definite, questionable, or none. Data handling will be based on protocols previously used in several other NIH sponsored clinical trials where eye retinal studies were performed.

The six specific aims of the study are to: (1) determine the relationship of retinal microvascular characteristics to measures of subclinical CVD through (a) magnetic resonance imaging of left ventricular function (b) brachial artery ultrasound for flow mediated endothelial vasodilatation (c) radial artery tonometry measurement of peripheral artery function (d) magnetic resonance imaging for myocardial perfusion; (2) determine relationship of retinal microvascular characteristics to clinical CVD, specifically: (a) coronary heart disease (b) congestive cardiac failure (c) stroke; (3) determine relationship of retinal microvascular characteristics to CVD risk factors, specifically:(a) development of type 2 diabetes (b) development of hypertension (c) markers of: (I) inflammation (II) hemostasis (III) fibrinolysis; (4) determine the relation of retinal microvascular changes to structural and functional disorders of the brain; (5) describe the prevalence of retinal microvascular abnormalities in different racial/ethnic groups; (6) describe the prevalence and risk factors of (a) diabetic retinopathy (b) age-related maculopathy.

Eligibility Criteria:
No eligibility criteria
EffectivenesS of Additional X-ray PRotection dEviceS in Reducing Scattered Radiation in Radial interventiOn

This study evaluates the radiation exposure of scattered radiation for the interventionalist during coronary angiography using different X-ray protection materials, namely, an X-ray Screen without additional X-ray protection, an X-ray Screen with additional protective strips and an X-ray Screen with additional protective strips AND protective patient cut-outs.


Eligibility Criteria:
Inclusion Criteria:

* indication for coronary angiography

Exclusion Criteria:

* none
The Effect of Transauricular Electrical Vagal Nerve Stimulation on Temporal Summation of Pain in Patients With Back Pain

The effect of transauricular electrical vagal nerve stimulation (taVNS) will be studied on temporal summation of heat pain (TSP) in 30 patients with chronic low-back pain and in 30 heathy volunteers. Participants will receive either taVNS or sham stimulation before and during TSP induction in a randomized crossover manner. The participants will be unaware regarding the type of intervention.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic low-back pain
* age 30-60 yrs old
* without heart disease
* low-back pain intensity at least 4 out of 10 points measured using NRS-10
* without cognitive deficits (Mini Mental State Shake \< 23)

Exclusion Criteria:

* opioid medication
* more than 1 low-back surgery
* sensory of motor neurological deficits at the level of back pain
* spinal stenosis
* diabetic polyneuropathy
* skin pathology at the site (cymba conchae) of stimulation
Follow-up Evaluating Clinical and Radiological Outcomes of Total Shoulder Arthroplasty With Permedica's MIRAI Prosthesis

This observational study is conducted in order to evaluate the effectiveness of the primary total shoulder arthroplasty with the Permedica's MIRAI Modular Shoulder Prosthesis System on the general population of patients who are about to undergo this surgery for every indication. Patients requiring a revision shoulder arthroplasty will not be enrolled.

The effectiveness will be evaluated in terms of recovery of shoulder function and stability of the prosthetic implant. The incidence of complications, adverse and serious adverse events will also be studied. Additional study aim is to evaluate a medium/long term survival of the prosthesis.

The duration of the study per single subject is 5 years.


Eligibility Criteria:
Inclusion Criteria:

* both genders
* at least 18 years old of age
* undergoing a primary total shoulder arthroplasty with MIRAI® Prosthesis System (anatomic or reverse, stemless or stemmed).
* Signed informed consent

Exclusion Criteria:

* Patients requiring a revision shoulder arthroplasty
* Persistent chronic or acute infections and all septic conditions
* Persistent osteomyelitis local or systemic
* Allergy or hypersensitivity to the substances contained in the materials of the implanted components
* Acute or chronic neurological and/or musculoskeletal impairment which compromises the shoulder joint function such as an axillary nerve injury affecting the deltoid muscle
* Inadequate bone structure which cannot guarantee stability to the prosthetic components
* Several vascular, nerve or muscular disorders, which compromise related extremities
* Marked osteoporosis, osteomalacia
* Hypotrophy of the periarticular soft tissues
* Dysmetabolic diseases such as, for example, kidney failure or systemic diseases
* Muscular insufficiency
* Active neoplastic or metastatic diseases
* Any other clinical or physical condition that can invalidate the surgery, the rehabilitation or the prosthesis stability
* Patient unwilling or unable to undergo the rehabilitation or to return to follow-up visits
* Women in pregnancy, childbearing potential or breastfeeding
* Involvement in other ongoing studies or clinical trial.
Study Evaluating HTC-867 in Healthy Young and Elderly Subjects

The purpose of this study is to assess the safety and tolerability of ascending single oral doses of HTC-867 in healthy young and elderly subjects. This study will also evaluate the way the drug enters and leaves the blood and tissues over time and how the drug acts on and in the body in a fasted and fed state.


Eligibility Criteria:
Inclusion:

1. Men or women of nonchildbearing potential (WONCBP) aged 18 to 50 years or 65 or greater inclusive at screening.

   WONCBP may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for ≥1 year (with follicle-stimulating hormone \[FSH\] ≥38 mIU/mL) and must have a negative pregnancy test result within 48 hours before administration of study drug.

   Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound scan.

   Sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after study drug administration.
2. Healthy as determined by the investigator on the basis of screening evaluations.
3. The elderly subjects must be generally healthy, but may be enrolled with a stable, chronic illness if it is well controlled and does not interfere with the primary objective of the study. Subjects may be included with clinically important deviations from normal limits in medical history, physical examination findings, vital sign measurements, 12-lead electrocardiograms (ECGs), or clinical laboratory test results that are associated with stable, chronic, and well-controlled medical conditions, so long as those deviations do not meet the stated specific criteria for exclusion

Exclusion:

1. Presence or history of any disorder that may prevent the successful completion of the study.
2. History of cardiac disorders (other than hypertension) including but not limited to valvular disease, congestive heart failure, angina pectoris, myocardial infarction, or arrhythmia.
3. History of vertigo.
The Applications and Influences of Transthoracic Echocardiography in Stroke Patients

Transthoracic echocardiography (TTE) is known to be an effective modality in assessing cardiac function as well as the structure of the heart. It was estimated that between 15% and 30% of ischemic strokes were due to a cardioembolic source, Therefore, TTE has been assumed as an important screening tool in patients with ischemic stroke, as atrial fibrillation is one of the leading risk factors. However, current guidelines have little evidence in whether performing TTE can alter clinical management and prevent a future stroke. We aim to present the association of performing TTE and clinical outcomes in stroke patients.


Eligibility Criteria:
Inclusion Criteria:

* patients with acute stroke and receiving echocardiography

Exclusion Criteria:

* patients with acute stroke and not receiving echocardiography
The Clinical Significance of Ovarian Function Detection and Protection in Fertility Preservation Surgery for Ovarian Malignancy

The design of this prospective interventional study is to investigate the clinical significance of applying GnRHa preoperatively and postoperatively and detecting physical and endocrinic change in fertility preservation surgery

20 patients with ovarian maligancies are anticipated to be enrolled in this study within 2 years. With their permission, they will be randomized into the control group and the experimental group when the latter is supposed to receive GNRHa preoperatively and postoperatively. And their physical and endocrinic indexes will be monitored. The effect of extra use of GnRHa will be observed by comparing these two groups' outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Volunteer to participate in the study with informed consent;
2. Females aged 10-90 who are confirmed with ovarian malignancy and are willing to receive GnRHa experimentally to preserve their fertility function.

Exclusion Criteria:

1. Pregnancy, lactation and postmenopause;
2. Suspected or identified as other tumors of genital tract;
3. History of hyperparathyroidism, infectious diseases (tuberculosis, AIDS), autoimmune diseases, or digestive system diseases (malabsorption, crohn disease and dysentery);
4. Other diseases or heavy injuries that will interfere with the results;
5. Simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.