cyrilzakka/clinical-trials huggingface dataset:
Establishment of Biomarkers for Fabry Disease

Fabry disease, an x-linked recessive lysosomal storage disease (LSD) is commonly recognized as a cause of renal failure in involved men and more recently recognized in women too. Women are involved in significant numbers and with complications, as are men, of vascular disease. This manifests as unexpected strokes in young adults. We have morphologic evidence that storage-endotheliopathy induced microvascular disease is the cause of cardiopathy and of cryptogenic strokes, and that storage endotheliopathy starts in early life, probably before birth. Based on our earlier work with other endotheliopathies such as diabetes mellitus, Susac syndrome, and hypertension, we will find and study patients using unique methods, neuro-retinal fluorescein angiography (NRFA), that we have developed for this purpose. These methods include NRFA to demonstrate capillary perfusion in the optic nerve head and retinal quadrants. We anticipate, based on our earlier experience with other endotheliopathies, that we will show more vascular pathology earlier than previously reported. Using epidemiologic and genetic tools we will find more patients than previously known or expected. It will offer opportunity for earlier diagnosis, prognosis, and response to enzyme replacement therapy.

We hypothesize that Fabry disease is a poorly recognized and poorly characterized cause of microvascular disease and cryptogenic strokes in young women and men. Neuroretinal capillary perfusion abnormalities in Fabry disease will be predictive of equivalent vascular disease in kidney, heart, brain and other organs, and further that it will be responsive to change induced by enzyme replacement therapy treatment.

Specific Aims

Specific Aim 1. To demonstrate the specificity and sensitivity of the diagnostic capabilities of a neuroretinal examination which includes slit lamp and fundoscopy, and NRFA for the diagnosis of Fabry disease on a subject population of identified FD patients.

Specific Aim 2. To show capillary perfusion abnormalities in optic nerve and retina using neuroretinal fluorescein angiography in patients with Fabry disease and compare these to renal (measured by GFR).

Specific Aim 3. To show that the change in capillary perfusion studies when compared to baseline in response to enzyme replacement therapy treatment over time, as a manifestation of tissue burden and prognosis is a more sensitive biomarker of the extent of patient disease than corneal keratopathy.

Eligibility Criteria:
Inclusion Criteria:

* Fabry patient
* evidence of angiopathy (renal, cardiac, or ocular)
* Patients above the age of 18

Exclusion Criteria:

* Patients unable or unwilling to provide written informed consent will not be recruited
* Patients who are below the age of 18
* Patients who have not or will not be undergoing Fluorescein angiography
* Allergy to fluorescein
* Pregnant women and fetuses are exclude from the study due to risks related to fluorescein and no direct benefit to the pregnant woman and fetus
Longitudinal Assessment of Autonomic and Sensory Nervous System in ALS

The goal of this interventional non-pharmacological study is to evaluate, using a multimodal approach, the progression of autonomic and sensory involvement in in amyotrophic lateral sclerosis (ALS) patients enrolled within 18 months from motor onset and its relationship with the progression of overall clinical disability.

The main questions it aims to answer are:

* Is autonomic dysfunction at diagnosis associated with disease progression and survival in patients with Amyotrophic Lateral Sclerosis ?
* Can we identify in the skin biomarkers to be used as reliable measures of disease progression and to apply in future clinical trials for patient stratification and to assess response to drug treatment ? Participants at time 0 will receive a full clinical and instrumental examination and a blood sample testing to check inclusion and exclusion criteria, genetic screening for the most common genes associated with ALS (SOD1, FUS, TARDBP and c9orf72), questionnaires about clinical characteristics, quality of life, pain and a multidomain battery of neuropsychological tests, multimodal assessment of the autonomic nervous system including skin biopsy for morphological study. At follow-up we'll perform clinical scales and skin biopsy.

Researchers will compare results from ALS patients with data obtained from a population of age and sex matched healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* ALS patients will be recruited within 18 months from the motor symptoms onset

Exclusion Criteria:

* glucose intolerance or conditions potentially affecting the peripheral nervous system
Effectiveness and Safety of Restylane Contour in the Treatment of Temple Hollowing

This is a randomized, no-treatment-controlled, evaluator-blinded, multi-center study to evaluate the effectiveness and safety of Restylane® Contour in correction of temple hollowing.


Eligibility Criteria:
Inclusion Criteria:

* Males or non-pregnant, non-breastfeeding females, 22 years of age or older
* Intent to undergo treatment for correction of temple hollowing

Exclusion Criteria:

* Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins
* Known/previous allergy or hypersensitivity to local anesthetics, e.g., lidocaine or other amide-type anesthetics or nerve blocking agents (if intended to be used for that subject)
* Previous facial surgery (e.g., facelift) above the level of the horizontal line from subnasale that in the Treating Investigator´s opinion could interfere with the study safety and/or effectiveness assessments
* Any previous aesthetic procedures or implants
* Recurrent temporal headaches such as temporal tendinitis migraine. Have a history of migraines or frequent headaches, as determined by the (Treating) Investigator, that could interfere with the study safety and/or effectiveness assessments
Prevention of Nosocomial Infection by Decontamination of the Naso- and Oropharynx With Chlorhexidine (NONI Trial)

Does chlorhexidine gluonate, a simple broad-spectrum antimicrobial agent with virtually no adverse-effects lower the incidence of NI after cardiac surgery, especially with respect to LTI and SSI?

Nosocomial infections (NIs) after open heart surgery are recognized as an important cause of morbidity and mortality with a prolonged hospital stay, increased need for of antibiotics, decreased quality of life and higher concomitant costs. Decontamination of the oropharynx seems important, since there is direct evidence of an association between pulmonary infection and oral health. Another important strategy involves the eradication of Staphylococcus aureus, the most important pathogen causing SSI. The most common reservoir of S.aureus is the anterior nares and eradication can be achieved by the application of topical antibiotics. Although promising results have been reported for both strategies, they are not widely used as routine prevention methods because of the variability of trial design, the concern about the emergence of antimicrobial resistance and increased costs. Further research is essential to evaluate different protocols, antimicrobial agents and cost-effectiveness.

Fur this purpose, we designed a clinical trial to study wether a simple broad-spectrum antimicrobial agent with virtually no adverse-effects would lower the incidence of NI after cardiac surgery, especially with respect to LTI and SSI.

Comparison(s): Oropharyngeal and nasal decontamination with chlorhexidine compared to placebo in patients after cardiothoracic surgery

Eligibility Criteria:
Inclusion Criteria:

* all adult patients (above 18) who were scheduled to undergo sternotomy for cardiothoracic surgery

Exclusion Criteria:

* emergency procedures, a preoperative infection and/or the use of antibiotics, hypersensitivity to chlorhexidine gluconate (CHX), absence of written informed consent or presence of an alternative prophylactic regimen like selective decontamination of the digestive tract
Endometrial Biopsy as Diagnostic Method for Endometriosis and Endometrioma

Our aim was to evaluate the efficacy of examining endometrial biopsy specimens for nerve fibers as a diagnostic test for endometriosis and endometrioma in a double-blind comparison with diagnostic laparoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Women in the reproductive age group undergoing laparoscopy for pelvic pain and/or infertility, and not currently receiving hormonal treatment for at least 3 months prior to laparoscopy will be included in the study
A Safety Study to Assess a DNA Vaccine Administered by Particle Mediated Delivery to the Skin in Healthy Subjects

The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given and any effects it may have on subjects' wellbeing. The study will also test the ability of vaccine to cause particular immune responses in the body.

Herpes simplex virus type 2 (HSV-2) infection is a serious public health problem, with up to 20% of the US population infected. Following primary infection, HSV-2 establishes a latent infection that can lead to recurrent disease when the virus reactivates. Genital lesions are often experienced with viral recurrence and these can be uncomfortable and painful, resulting in significant anxiety and social distress. There are no commercial vaccines available for therapy of HSV-2 infection.The aim of a therapeutic vaccine would be to enhance such natural responses by boosting the appropriate cellular immune response to HSV-2 in those latently infected individuals who experience frequent and unwanted reactivations. The purpose of this study is to evaluate the safety and tolerability profile of a therapeutic DNA vaccine (pPJV7630) in combination with a DNA encoded immunostimulator (pPJV2012) when administered by Particle Mediated Epidermal Delivery (PMED)

Eligibility Criteria:
Otherwise healthy subjects with seronegative HSV-2
Altering Bicarbonate Delivery During Hemodialysis to Affect Filtration of Indoxyl Sulfate

This is a non randomized crossover trial investigating whether changing the pattern of bicarbonate administration during hemodialysis will result in the more efficient filtration of highly protein bound solutes. The experimental group will be dialyzed with low bicarbonate dialysate for the first half of dialysis then switched over to normal bicarbonate dialysate for the second half. The control group will be dialyzed entirely with normal bicarbonate dialysate. The two groups will switch one week late and patients will serve as their own matched controls for a completely standard dialysis and one that is split into two halves with different bicarbonate concentrations.

Investigators will try to perform dialysis with a low bicarbonate bath which will leave patients blood pH (Hydrogen ion concentration) relatively unchanged then switch to a normal bicarbonate bath during the second half of dialysis so that they attain the pH (Hydrogen ion concentration) they normally would. Investigators will use these measurements to test test the hypothesis that Indoxyl Sulfate (IS) binds to proteins with greater affinity under basic conditions and further to test the hypothesis that it is possible to remove a greater amount of Indoxyl Sulfate (IS) when patients are maintained relatively acidotic during dialysis for a longer period of time due to the greater availability of free IS that can pass through the dialyzer.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Stable Dialysis for at least 6 months

Exclusion Criteria:

* Patients with serum potassium concentration below 4.0 mEq/L on previous monthly lab test or corrected serum calcium below 8.5 mEq/L
* Hospitalization within the past 12 months
* Adults unable to consent
* Children
* Pregnant women
* Prisoners
Mechanical Traction Force and Knee Joint Space

the purposes of this crossover study are to Purpose

1. To determine the most effective traction force for knee joint that can be used in the treatment of patients with KOA.
2. To determine the influence of knee joint traction on ROM ok knee joint flexion and extension
3. To determine the influence of knee joint traction on the flexibility of hamstring muscles

this study is a pilot study design aiming to determine the most effective mechanical traction force used for knee joint treatment. this effectiveness was assessed in favor of the separation of the joint surfaces in cm in addition to the hamstring flexibility measured in cm and active knee flexion range of motion.

according to previous literature, there is no consensus regarding the most appropriate traction force that can produce statistical and clinically meaningful differences so we started this pilot study.

the results of this study will be used to conduct a larger-scale study using the most appropriate traction force on patients having knee osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy subject
2. males or females
3. No previous surgery in lower limbs

Exclusion Criteria:

1. Diseased knee joint
2. Knee osteoarthritis
3. Any musculoskeletal problem in the lower extremities
4. Varicose veins
5. Pregnancy
Study Evaluating the Effect of IMA-638 in Subjects With Persistent Asthma

Primary purpose is to assess if IMA-638 is safe and improves asthma in subjects with persistent asthma.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy men and women with persistent asthma, 18 to 70 years of age, with body weight between 50 kg and 115 kg.
* History of treatment with a medium to high dose of inhaled corticosteroids (ICS), with or without long-acting beta-agonists (LABA), for at least 2 months prior to the screening visit and must remain constant during the study.
* FEV1 ≥ 55% to ≤ 80% predicted and demonstrated improvement in FEV1 (L) with inhaled albuterol (salbutamol) (reversibility) of ≥ 12%.

Exclusion Criteria:
Physiologic Adaptations to Interval and Continuous Running at Low Volume and Vigorous Intensity Over 14-Weeks.

The purpose of this study was to verify physiological responses to constant-load (continuous) vs. variable-intensity (interval) during 14 weeks of aerobic exercise on active men. The hypothesis was that would be differences in physiological variables on distinct modes of execution performed on the treadmill over a period of 14 weeks of training.

Initially there were thirty five subjects, but due factors outside the present study, three individuals were excluded from the program. Two individuals during maximal exercise test (VO2) showed clinical impairment test being interrupted by the doctor and the third individual presented a plantar fasciitis in the early familiarization. Thirty two healthy and active males volunteered to participate in the study. All subjects exercised habitually, with at least 1 year experience aerobic training. The Human Ethics Committee of Rio de Janeiro Federal University approved this study (no 58659/02471312.8.0000.5257).The subjects performed a total of nine visits to the laboratory of the Brazilian Navy at City of Rio de Janeiro for physical tests on different days, except between visits I-II and VII-III. The interval between visits was one week between visits II-III-IV and VIII-IX, six weeks between the first day of training and visits V, four weeks between V-VI-VIII. All subjects from interval and continuous groups performed a total of 46 sessions of supervised running program.

Eligibility Criteria:
Inclusion Criteria:

* self reporting no contraindication to high-intensity exercise.
* physically active on cardiorespiratory activities in a regular basis for at least six months.
* presence of negative responses on all items of the Questionnaire of Physical Activity Readiness (PAR-Q Test).

Exclusion Criteria:

* make use of medication that may interfere with the results, especially inhibitors appetites and dietary supplements.
* presence of joint problems that prevents the achievement of training.
* presence of disorders such as diabetes, dyslipidemia and anemia
* have performed intense exercise with lowers members before the training sessions.
TraceIT Tissue Marker to Mark the Primary Resection Bed Margins of Oropharyngeal Cancers

The purpose of this research study is to look at how using an injectable marker called TraceIT can help with the radiation treatment planning process. TraceIT is a gel that dissolves in the body over time and can be injected and is visible on many types of images that can be used in the treatment planning process. If the exact edges of negative tumor margins can be marked before treatment planning, it is thought that the area receiving radiation can be more personalized, thus potentially reducing unnecessary radiation to areas that are cancer-free.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed (by routine H\&E staining) or highly suspicious for oropharyngeal squamous cell cancer.
* Planned treatment includes transoral surgery followed by adjuvant intensity modulated radiation therapy (IMRT).
* At least 18 years of age.
* Ability to understand and willingness to sign an IRB approved written informed consent document.

Exclusion Criteria:

* Distant metastatic disease at the time of definitive treatment, and thus study, initiation.
* History of major head \& neck surgery or previous head \& neck irradiation.
* History of or current oral disease that may interfere with interpretation of study outcomes.
* Currently enrolled in another radiation therapy trial that has not completed its primary endpoint or that clinically interferes with this study.
* Poor surgical candidate
* Prisoners
Remote Ischemic Conditioning in Necrotizing Enterocolitis

Necrotizing enterocolitis (NEC) affects up to 10% of very preterm infants. NEC mortality is high (30-50 %) and has remained unchanged over the last decades. New treatments are urgently needed. NEC pathogenesis is multifactorial, but bowel ischemia plays an essential role in NEC development. Remote ischemic conditioning (RIC) consists in inducing brief periods of non-lethal ischemia in a limb distant to an organ suffering from ischemia. RIC has been used in adults, children and term neonates with a variety of diagnosis. However, no study has been done including preterm infants with NEC.

An appropriately sized blood pressure cuff will be applied to an arm or leg and inflated to promote RIC. This study will be conducted in three phases to assess the feasibility and safety of RIC in relation to duration of ischemia time, number of cycles of RIC and whether it is feasible and safe to perform RIC on consecutive days.

Eligibility Criteria:
Inclusion Criteria:

* Patients with NEC (stages I-III Bell's Classification)
* Weight greater or equal to 750 g.
* Gestational age \< 36 weeks.
* Patients whose parents consent to participate in the study.

Exclusion Criteria:

* Patients with major congenital anomalies
* No antecedent of limb ischemia/limb thrombotic events.
* No antecedent diagnosis of occlusive arterial or venous thrombosis
* Hemodynamic instability
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)

The primary objective of this study is to compare progression-free survival (PFS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing
* No history of systemic anticancer therapy in metastatic/non-curable settings
* Eastern Cooperative Oncology Group (ECOG) ≤ 1

Exclusion Criteria:

* Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology
* Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved
* Symptomatic (treated or untreated) brain metastases
* Gastrointestinal (GI) tract disease causing the inability to take oral medication
* Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina
* Prior therapy with a KRAS G12C inhibitor
Airway Peak Pressure-directed Laryngeal Mask Airway Intracuff Pressure Setting

The investigators aimed to explore the effects of airway peak pressure (Ppeak) guidance on the least laryngeal mask airway (LMA) intracuff pressure setting during general anesthesia and the effects on postoperative complications in the throat. One hundred and twenty patients (American Society of Anesthesiologists grades I or II) scheduled for elective laparoscopic cholecystectomy under general anesthesia were enrolled in our study. The patients were divided into pressure-regulated group (group P) and control group (group C) randomly. Supreme LMA was inserted in after general anesthesia induction. Air was injected into the cuff to make the intracuff pressure (ICP) achieve 60 cmH2O. Volume-controlled ventilation was selected and Ppeak was recorded. In group P, all the gas in the LMA cuff was sucked out, and then air was injected in during expiration phase to make ICP achieve the level of Ppeak. If there's any leakage, increase 5 cmH2O every time till there's no air leakage from the mouth. After pneumoperitoneum, the cuff was inflated to make ICP achieve 60 cmH2O and Ppeak was recorded once more. Then all the gas in the LMA cuff was sucked out, and air was injected into the cuff during expiration phase to make ICP achieve the level of Ppeak as the above method till the end of operation. During pneumoperitoneum, the pressure of CO2 was set at 10 cmH2O. In group C, ICP was maintained at 60 cmH2O. Ppeak, ICP and the intracuff gas volume were recorded before and after pneumoperitoneum. ICP during inspiratory phase in the two groups was measured. Tidal volume during inspiration (VTI) and expiration (VTE) in the two groups were recorded, and the leakage rate was calculated as \[(VTI-VTE)/ VTI×100%\]. Throat complications of all the patients in 24 hours after surgeries were also recorded.


Eligibility Criteria:
Inclusion Criteria:

* Patients with American Society of Anesthesiologists grades I or II scheduled for elective laparoscopic cholecystectomy under general anesthesia

Exclusion Criteria:

* Patients with limited head and neck activity, limited mouth opening, high abdominal pressure, inflammation of the throat and respiratory diseases