cyrilzakka/clinical-trials huggingface dataset:
L-Arginine Metabolism in Essential Hypertension

Essential hypertension is characterized by impaired endothelial function. Data derived from normotensive subjects with a genetic predisposition to arterial hypertension suggest that endothelial dysfunction is a cause rather than a consequence of the condition. Given that, in normotensive offspring of hypertensive parents, impaired endothelium dependent vasodilation can be restored by supplementation of the nitric oxide (NO) precursor L-arginine, a defect in the L-arginine/NO pathway can be postulated. The investigators at the University of Erlangen-Nuremberg, hypothesize that impaired endothelial function in essential hypertension is associated with alterations in L-arginine metabolism and transport. This study will determine whether metabolism and transport of L-arginine are altered in patients with essential hypertension and whether these potential alterations can be targeted therapeutically.


Eligibility Criteria:
Inclusion Criteria:

* Males, ages 18-65
* Male and female healthy control subjects ages 18-65

Exclusion Criteria:

* Any other coexisting condition
* Advanced damage of vital organs (grade III und IV retinopathy)
* Therapy with a not approved concomitant medication in the last 4 weeks prior to intake of the first trial medication, especially lipid lowering and antidiabetic medications (washout phase)
* Blood donation within the last 4 weeks
* Patients with arterial fibrillation or atrioventricular (AV)-block (II and more)
* Patients with anamnestic myocardial infarct
* Patients with depression
* Patients with seizure disorders
* Patients with unstable angina pectoris including electrocardiogram (ECG)-aberrations or cardiac insufficiency New York Heart Association (NYHA) Stadium III and IV
* History of a malignant illness with the exception of those patients who have recovered for more than 10 years or have a basalioma of the skin.
* Actual or anamnestic alcohol or drug abuse
* History of organ transplant
* Anaphylaxis or known therapy resistance to any of the used test matters.
* Therapy with a not approved concomitant therapy
* Participation in another study within three months prior to study inclusion
* Illnesses, which can influence the pharmacodynamics or pharmacokinetics of the test substance
* Liver or kidney diseases: SGOT, GPT , γ-GT, AP, bilirubin and creatinine above 200% of standard
* Patients who are not sufficiently compliant; or patients who are not capable or willing to appear for controlling visits.
* Severe or unstable medical or psychiatric illnesses, which will, in the estimation of the examiner, endanger the safety of the proband or the successful participation in the study
* Presumed risk of transmission of HIV or hepatitis via blood from the proband
Characterization and Outcome of Children With Leukodystrophy: An Observational Study at Sohag University Hospital

Leukodystrophies are heterogeneous genetic disorders characterized by the selective involvement of white matter in the central nervous system (CNS) (1, 2). Inherited leukodystrophies are diseases of the myelin, including abnormal myelin development, hypomyelination, or degeneration of myelin (3, 4).

Most of these disorders fall into one of three categories; lysosomal storage diseases, peroxisomal disorders, and diseases caused by mitochondrial dysfunction and each leukodystrophy has distinctive clinical, biochemical, pathologic, and radiologic features (5).


Eligibility Criteria:
Inclusion Criteria:

* The patients fulfilling all the following criteria will be included:

  1. Age ≤ 18 years.
  2. The presence of typical clinical, biochemical, and neuroimaging features of leukodystrophies.

Exclusion Criteria:

* 1- Children who have coexistent genetic disorders. 2- Children who have cerebral malformations. 3- History of perinatal asphyxia. 4- History of head trauma or intracranial hemorrhage. 5- Acquired CNS myelin disorders, such as multiple sclerosis and related acquired demyelinating processes, infectious and post-infectious white matter damage, toxic injuries and non-genetic vascular insults.
A Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa (HS)

The primary purpose of the study is evaluate the effect of brensocatib compared with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of HS (confirmed by a dermatologist), with a history of HS for at least 6 months before the Screening Visit.
* Moderate or severe HS defined as a total of ≥6 inflammatory lesions (inflammatory nodules and/or abscesses) for at least 8 weeks before the Baseline Visit.
* HS lesions in at least 2 distinct anatomic areas, 1 of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline Visits.

Exclusion Criteria:

* Draining tunnel count of ≥20 at the Baseline Visit.
* Surgical or laser intervention for an HS lesion during the Screening Period.
* Clinical diagnosis of Papillon-Lefèvre Syndrome.
* Participants with an absolute neutrophil count \<1,000/mm3 at the Screening Visit.
* Participants having active liver disease or hepatic dysfunction.
* Have diagnosed periodontal disease under active management by a dentist or expected to have periodontal disease-related procedures within the study period.
* Received systemic (intravenous or orally \[PO\]) antibiotic therapy within 8 weeks before the Baseline Visit

  a. Doxycycline or minocycline 100 mg twice daily provided the dosing regimen being stable for at least 8 weeks before the Baseline Visit and is expected to continue.
* Received PO or transdermal opioid analgesics (except tramadol) for any reason within 4 weeks before the Baseline Visit.
* Permitted analgesics for HS-related pain have not been at a stable dose regimen for at least 4 weeks before the Baseline Visit.
* Received prescription topical therapies for the treatment of HS within 2 weeks before the Baseline Visit.
* Received any anti-tumor necrosis factor (TNF)-α/other biologics treatment within 12 weeks or 5 elimination half-lives, whichever is longer, before the Baseline Visit.
* Received systemic nonbiologic therapies (eg, corticosteroids and retinoids) for HS within 4 weeks before the Baseline Visit.
* Received any immunomodulatory agents within 4 weeks before the Baseline Visit.

Note: Other Inclusion/Exclusion criteria may apply.
Obesity Childhood in Cuenca-Ecuador: Prevalence and Risk Factors

Hypothesis: Obesity in children of Cuenca is related with socioeconomical status and physical activity habits.

Summary:

The prevalence of obesity and overweigh in all age groups are increasing rapidly in the world. Some factors like physical activity, socioeconomical status, dietary habits, gender, besides genetic factors influence in the development of obesity.

In Cuenca - Ecuador lack information related to prevalence of overweight and obesity in children and the risk factors related.

Socioeconomical status and quality of physical activity are assessed using specially designed questionnaires in a randomized sample of children 6 to 9 years of age of Cuenca city. Nutritional status is assessed using body mass index, relation weight/age and height/age. These data are helpful to develop programs focused to improve nutritional status in scholars of Cuenca.


Eligibility Criteria:
Inclusion Criteria:

* All children of selected sample with an approved consent by their parents

Exclusion Criteria:

* Children with malformations that not permit take anthropometric measures.
A Study To Assess GW433908 (Fosamprenavir) Containing Regimens In HIV-1 Infected Subjects

GW433908 (fosamprenavir; FPV)is a pro-drug of amprenavir (APV) which is more water soluble and can be formulated into a tablet with a reduced pill burden (four 700mg tablets of FPV versus sixteen 150mg capsules daily for APV. This study is designed to provide additional information on long term safety and tolerability of FPV containing regimens for those subjects who received FPV in previous GlaxoSmithKline studies.

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant/non-lactating females \>/=13 years of age (or \>/= 18 years of age according to local requirements).
* Received fosamprenavir through prior participation in APV20001, APV30002, APV30003 or PRO30017 or have participated in APV30001 or other studies as deemed appropriate by the project team.

Exclusion Criteria:

* Permanent discontinuation of GW433908 in a previous study due to intolerance.
* An active CDC Class C Event.
* Any condition which, in the opinion of the investigator, would preclude a subject from participation.
Comparing Effects of Two Fixed Combinations Ophthalmic Solutions on Ocular Blood Flow

A 10 week evaluation, crossover design study including a 3 week washout period between treatments, to determine the effects of Combigan® (fixed combination brimonidine tartrate 0.2%/timolol maleate 0.5%) and Cosopt® (fixed combination dorzolamide hydrochloride-timolol maleate ophthalmic solutions) on ocular blood flow as measured by retrobulbar blood flow.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 30 years or older.
2. Primary open-angle glaucoma (POAG) or ocular hypertensive in at least one eye.
3. Best corrected visual acuity at least 20/40 in at least one eye.

Exclusion Criteria:

1. History of acute angle-closure or a narrow, occludable anterior chamber angle by gonioscopy.
2. History of chronic or recurrent inflammatory eye diseases (e.g., scleritis, uveitis).
3. History or signs of intraocular trauma.
4. Any abnormality preventing reliable applanation tonometry.
5. Current use of any ophthalmic or systemic steroid which may interfere with this investigation.
6. Severe, unstable or uncontrolled cardiovascular, renal, or pulmonary disease.
Macugen Observational Study

The objective of this observational study is to evaluate the effectiveness and safety of Macugen for treatment of wet age-related macular degeneration (AMD) in Indian patients.Prospective, Observational, Non-interventional Study. The period of observation for the study will be 1 year

To be eligible for enrollment in this study, patients must receive the first injection of Macugen intravitreal in at least one eye for treatment of wet age-related macular degeneration (AMD). The decision to prescribe Macugen will necessarily precede and will be independent of the decision to enroll patient into the study.

If both eyes of a patient receive injection Macugen, only one eye will be included in the study. If both eyes receive first injection Macugen after initiation of the study, only the first treated eye will be included in the analysis. If one eye has already received Macugen when the study starts and the second eye receives injection after the study initiation, the second eye will be included in the analysis.

The study was prematurely discontinued due to delay in meeting pre-defined protocol recruitment milestones on August 30, 2010. There were no safety concerns regarding the study in the decision to terminate the trial.

Eligibility Criteria:
Inclusion Criteria:

* To be eligible for enrollment in this study, patients must receive the first injection of Macugen intravitreal in at least one eye for treatment of wet age-related macular degeneration (AMD).

Exclusion Criteria:

* Active or suspected ocular or periocular infection.
* Known hypersensitivity to pegaptanib sodium or any other excipient in this product.
The Impact of Covid 19 Pandemic on the Training of General Surgery Residents

The educational process of general surgery residents is a very important step in every surgeon's career, which is often overlooked or neglected. The Covid-19 pandemic has inflicted deep changes in the medical activity in general and in the training process of young doctors in particular.

Our study aims to assess the impact of the Covid-19 pandemic on the educational process of general surgery residents, through a comparative study. The responses of resident doctors at a questionnaire, in two different time periods, will be compared: pre-Covid era (December 2019) and Covid era (December 2020).


Eligibility Criteria:
Inclusion Criteria:

* General surgery residents
* Above second year of residency
* Residency program in Cluj-Napoca Medical Centre

Exclusion Criteria:

* Incomplete responses to the questionnaire
* Refusal to be included in the study
Measuring Changes in Acute Pain in the Emergency Department Using Patient Reported Scales

Patient reported pain, stress, and anxiety measures have been found to be inter-related, but it is not known if they are all associated with receiving opiate medications. The objective of this study is to determine if patients' degree of reported pain, stress, or anxiety is associated with receiving opiate pain medications in the emergency department or at discharge. Alert patients at least 18 years of age and who report pain greater than 3/10 are eligible to participate in the study. Consenting patients complete Visual Analog Scales describing their perceived pain, stress, and anxiety from enrollment until discharge. Demographic data and administration of pain medication is also recorded. Visual Analog Scale scores among patients who received an opioid pain medicine in the emergency department and at discharge will be compared to those who did not.


Eligibility Criteria:
Inclusion Criteria:

* Reported pain greater than or equal to 3 out of 10

Exclusion Criteria:

* Less than 18 years of age
* Decreased level of consciousness
* Inability to answer questions
* Prisoner
Evaluation of Neurotoxic Effect of Sevoflurane-Based AnaesthesiaGuided by Short-Term Olfactory Identification

Nowadays there is increasing doubts about the safety of anesthesia . Anesthesiologists have to console the worried patients, who are anxious about the potential risks of anesthetic-induced brain damage, by suggesting that any detrimental effects would be "mild".Anesthetics are responsible for postoperative taste and odor defects and cognitive dysfunction.

Aims: The aim of this study is to assess the effect of isoflurane, sevoflurane, propofol and regional anesthesia on the olfactory threshold, olfactory identification and endocrine regulation of associative memory in the postoperative period in old age group.

Methods: 600 patients (\> 60years ) fulfilling the criteria of the American society of anesthesiologists and II status were selected for this prospective single-blinded randomized controlled study. Patients were randomized into one of four groups to receive regional anesthesia (control group), general anesthesia with sevoflurane, general anesthesia with isoflurane and total intravenous anesthesia with propofol.

Mini-Mental State Examination (MMSE), olfactory threshold, and olfactory identification were tested at 12 hours preoperatively (T0), at 3 hours postoperatively (T1) and at the time of discharge or postoperative 3 days (T2). In addition, serum melatonin levels were estimated at T0 and T1.

N-butyl alcohol was used to test the olfactory threshold and the Pocket Smell Test TM series (PSTs) was used to test olfactory identification. Data were analyzed using the one-way analysis of variance, Kruskal-Wallis or Mann-Whitney tests.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anaesthesiologists I and II physical status
* aged from 60 to 75years
* scheduled for elective surgery with the anticipated duration of 100-120 min.
* surgical procedures included hernia repair,
* varicose vein surgery,
* incisional hernia repair,
* minor gynecological procedures,
* lower limb orthopedic procedures,
* minor urological procedures

Exclusion Criteria:

* Patients with recent airway infection,
* allergic rhinitis,
* nasal polyps,
* history of alcoholism,
* smoking,
* mental retardation,
* psychiatric illness,
* neurosurgical or oto-rhino-laryngeal surgery
* patients with a history of olfactory deficits and cognitive impairment
Reprogramming Energy Homeostasis in Overweight Individuals Via Exercise, Cognitive, and Social Training

The RESILIENT project is a clinical trial investigating leptin sensitivity in both children and adults with overweight or obesity. The study examines the additive effects of Cognitive Training (CT) and Social Training (ST) on leptin sensitivity, compared to stand-alone Intensive Health Behaviour Treatment (IHBT), which includes diet and Physical Activity (PA).

The intervention will last for 8 weeks, followed by a 12-week washout period. A multilevel assessment will be conducted, evaluating in vivo leptin sensitivity (through the ratio of leptin levels to caloric intake) as well as ex vivo molecular analysis of leptin signaling in Peripheral Blood Mononuclear Cells (PBMCs). Additionally, clinical, psychological, cognitive, and physiological assessments will be performed to assess the efficacy of each intervention. By investigating leptin resistance as a potential molecular bridge between metabolic dysregulation and cognitive dysfunctions, this study may contribute to the development of more effective, long-term treatments for obesity and overweight. Additionally, in vivo investigation of leptin sensitivity may be particularly important for providing evidence of the metabolic and cognitive effects necessary for developing novel anti-obesity treatments.


Eligibility Criteria:
Inclusion Criteria:

* a condition of overweight or obesity
* Intelligence Quotient (IQ) ≥ 85

Exclusion Criteria:

* genetic or syndromic obesity;
* reduced mobility;
* systemic diseases;
* ongoing pharmacological treatment for chronic conditions.
Perioperative Vitamin C to Reduce Persistent Pain After Total Knee Arthroplasty

Phase II Multicentre, pilot, parallel-group, blinded, 1:1 randomized controlled trial to determine the feasibility of conducting a larger definitive trail of using vitamin C to reduce persistent pain in patients undergoing total knee arthroplasty surgery.

PROVISION is a multicentre, pilot, parallel-group, blinded, randomized controlled trial of 300 patients undergoing total knee arthroplasty surgery. Consented eligible patients will be randomized to receive vitamin C: 2000 mg taken orally within 4 hours of the start of surgery, followed by 500 mg of vitamin C taken twice daily from post-operative day 1 to day 56 (8 weeks). Patient in the control group will receive placebo lactose monohydrate capsules. Study medications will be prepared to look similar and labelled as per regulatory requirements. Patients will follow up on post-operative days 1-3, weeks 2,4,6, and 8 post-operatively, and at 3- and 12-months post-operatively to report on pain, opioid and analgesic consumption, medication adherence, adverse events, functional, mood, and quality of life outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years old
* Undergoing a unilateral or bilateral primary total knee arthroplasty for advanced osteoarthritis of the knee

Exclusion Criteria:

* TKA for infection (septic joint), fracture, ankylosing spondylitis, lupus, or psoriatic arthritis
* History of kidney stones, acute or chronic renal failure, hemochromatosis, or glucose-6-phosphate deficiency
* Unlikely to comply with follow-up (e.g., no fixed address, plans to move out of town)
* Language difficulties that would impede valid completion of questionnaires
* Planned staged bilateral TKA
* Treating surgeon deems patient inappropriate for inclusion in trial
* Any allergy or sensitivity to milk
* Pregnant or planning to become pregnant during the study
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess Safety and Efficacy of Ambrisentan in Subjects With Pulmonary Arterial Hypertension.

A phase 3, randomized, double-blind, placebo-controlled study to assess safety and efficacy of ambrisentan in subjects with pulmonary arterial hypertension.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Current diagnosis of either PPH or PAH secondary to the scleroderma spectrum of disease, systemic lupus erythematosus, anorexigen use, or HIV infection at the Screening Visit
* Right heart catheterization, completed prior to Screening Visit must meet pre-specified hemodynamic criteria
* Female subjects of childbearing potential must have a negative serum pregnancy test and must agree to use a reliable double barrier method of contraception until study completion and for at least four weeks following their final study visit
* Male subjects must be informed of the potential risks of testicular tubular atrophy and infertility associated with taking this study drug and queried regarding his understanding of the potential risks as described in the Informed Consent Form

Exclusion Criteria:

* PAH due to or associated with congenital heart disease, coronary artery disease, left heart disease, interstitial lung disease, chronic obstructive pulmonary disease, veno-occlusive disease, chronic thrombotic and/or embolic disease, or sleep apnea
* Portopulmonary hypertension
* Bosentan within four weeks prior to Screening
* Phosphodiesterase type V inhibitor or chronic prostanoid therapy within four weeks prior to Screening
* IV inotrope use within two weeks prior to Screening
* ALT or AST lab value that is greater than 1.5 times the upper limit of normal
* Pulmonary function tests not meeting pre-specified criteria
* Contraindication to treatment with an ERA
* History of malignancies other than basal cell carcinoma of the skin or in situ carcinoma of the cervix within the past five years
* Females who are pregnant or breastfeeding