cyrilzakka/clinical-trials huggingface dataset:
Natural History and Clinical Features of Amyotrophic Lateral Sclerosis (ALS)

1. Describe the distribution of ALS in mainland China, to explore the differences in the number of ALS in different times, regions and populations in order to further explore the causes affecting the distribution of ALS;
2. To investigate the cause of ALS in mainland China in the crowd disease development process and the corresponding characteristics change ;
3. To explore the effect of prognosis of ALS;

With the development of supportive measures, the natural history of ALS has changed. Researchers compared the natural history of ALS patients from 1999-2004 and 1984-1998 and found that the median survival time was significantly longer in the former than in the latter (4.32 years vs. 3.22 years) and that the disease progression was slower in the former, even after adjusting for other confounding factors. Although previous studies have provided reference for the diagnosis and treatment of ALS, the etiology of ALS is still unknown, and the relevant clinical features and natural history of ALS still lack the verification of large samples. Therefore, the research on the natural history of ALS is of great significance to further increase the understanding of ALS and provide new evidence for the diagnosis and treatment of ALS.

Eligibility Criteria:
Inclusion Criteria:

- Patients were diagnosed with ALS recruited from all participant clinical centers.The diagnosis of ALS was made using the revised El Escorial criteria for definite, probable, lab-supported, and possible.

Exclusion Criteria:

* Decline to follow-up.
Epidemiology Non-cholera Vibrio Infections

The purpose of this study is to identify the epidemiological and clinical characteristics of patients diagnosed with non-cholera Vibrio infection in Western France from 2000 to 2019.

Vibrios are gram-negative, ubiquitous bacteria of the marine flora and are found particularly in warm waters. For example, the incidence is high in Florida and Vibrio infections are now reportable in the United States. Different species of Vibrio are described. A distinction is made between choleric vibrios belonging to serogroups O1 and O139, responsible for cholera epidemics, and non-choleric vibrios. Our study will focus on non-cholera vibrios. Vibrio infections can occur by eating contaminated raw seafood or by exposure of a wound to the marine environment. They occur mainly during the hot summer months. This can be explained on the one hand by higher water temperature and on the other hand by increased beach use. With global warming, it is possible that Vibrio infections may increase in number and location.

Eligibility Criteria:
Inclusion Criteria:

* non-cholera Vibrio infection

Exclusion Criteria:

* vibriosis to Vibrio cholerae O1 and O139
Retinal Ganglion Cell Layer in Patients With Intracerebral Processes

Transsynaptic degeneration of the retinogeniculate pathways is well documented to occur in nonhuman primates when the cerebral lesion occurs even during adulthood. In case of humans, retrograde transsynaptic degeneration of the retinogeniculate pathways has been shown to occur following prenatal or perinatal lesions, but its occurrence after cerebral lesions in adults is considerable rare. It is, however, well established that retrograde transsynaptic degeneration affects other neural systems in humans even when the injury occurs during adulthood. Some histopathological evidence points to the possibility of transsynaptic degeneration of the retinogeniculate pathway in humans even when the lesion occurs in adults, but the clinical significance is unknown.'

Purpose:

To measure the retinal ganglion cell layer (GCL) in patients with visual field defects due to intracerebral processes. To correlate GCL with the localization and type of intracerebral lesion.

To compare the GCL with the retinal nerve fibre layer (RNFL) to investigate, which of the 2 parameters is more sensitive to show retinal layer abnormalities.

To correlate GCL with visual field defects and electrophysiological parameters.


Eligibility Criteria:
Inclusion Criteria:

* adult patients with intracerebral lesions within the central visual tract
* associated visual field defects
* investigations (OCT, ERG) possible

Exclusion Criteria:

* lesions within the optic nerve without extension in the optic tract
* neurological disease
* optic disc anomalies: glaucoma, nystagmus, high myopia
Increasing Viral Testing in the Emergency Department

The purpose of this study is to determine if a brief intervention delivered to emergency department patients increases the uptake of rapid HIV and hepatitis C testing in comparison to no brief intervention.


Eligibility Criteria:
Inclusion Criteria:

* Emergency department patient.
* Does not know HIV or hepatitis C status.
* Has an ASSIST V3 score that indicates recent illicit and/or prescription drug use.
* Fluency in English or Spanish.

Exclusion Criteria:

* Critically ill or injured.
* Homicidal and/or suicidal intention.
* Age \< 18 years or \> 64 years.
* Does not speak English or Spanish.
Spacer Graft Study

To determine which of three types of spacer grafts (hard palate vs autologous ear cartilage vs Enduragen) are the most effective in lower eyelid retraction repair outcomes as measured by MRD2 (margin to reflex distance 2)

Lower eyelid retraction is a common eyelid malposition, typically caused by thyroid eye disease, excessive resection of skin in a cosmetic lower eyelid blepharoplasty, vertical rectus muscle recession, facial nerve paralysis, or a normal anatomical variant. When the lower eyelid is displaced inferiorly, exposing sclera between the limbus and the eyelid margin, symptoms can vary from ocular irritation and discomfort to vision threatening corneal decompensation. If medical management does not suffice, surgery is indicated.

Although lower eyelid retractor lysis alone has been described, supporting material (spacer graft) placed to augment the posterior lamella is generally required for more effective elevation of the eyelid. Various materials have been utilized, including autologous auricular cartilage, bovine acellular dermal matrix, porcine acellular dermal matrix, hard palate mucosa, dermis and dermis fat grafts. Previous studies on acellular dermal matrix use in lower eyelid retraction repair consist of retrospective efficacy studies with only 2 comparative studies. However, conflicting results raised doubt as to which material was superior. In addition, a prospective, randomized comparative study of spacer grafts used for lower eyelid retraction repair was done comparing autologous auricular cartilage, porcine acellular dermal matrix, and bovine acellular dermal matrix. The results yielded no statistically significant difference in surgical outcomes and complications. As of now, surgery with any of the spacer grafts, including autologous hard palate, is accepted as standard of care.

This study is designed to determine whether using hard palate as a spacer graft will have statistically significant different surgical outcomes and complications as compared to autologous ear cartilage and porcine acellular dermal matrix spacer grafts. Although studied separately, this has not been studied before in a prospective randomized manner and may prove to demonstrate improved surgical results and decreased complications. This can guide future choice of spacer graft used in lower eyelid retraction repair surgery.

Eligibility Criteria:
Inclusion Criteria:

* Underwent lower eyelid retraction repair requiring a spacer graft between July 1, 2019 and July 1, 2022

Exclusion Criteria:

* Younger than 18 years old
* Required concurrent surgeries (e.g., midface lift or full thickness skin graft) or required further surgeries on the operated eyelid within the 6 months postoperatively
* Patients with less than 1-month follow up will be excluded from all outcome analysis and those without postoperative 6-month data will be excluded from the postoperative month 6 MRD2 calculation
Bioequivalence of Alprazolam Sublingual vs Oral Tablets

This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from a standard orally administered tablet.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects
* BMI 17.5 - 30.5
* Must provide informed consent

Exclusion Criteria:

* Clinically significant disease
* Narrow angle glaucoma
* Positive drug screen
Care Expansion Across Remote Environments - Sub-Study of the SELF-GYN1 Trial

This real-world, interventional sub-study will evaluate the impact of potential payer subsidies for Turtle Health at-home consults on subsequent interactions with the healthcare system within select sub-populations of interest.

The present study is a sub-study of the SELF-GYN1 study. The SELF-GYN1 study is a multicenter study designed to evaluate the efficacy and safety of the use of the Turtle Health Ultrasound Scanner for the acquisition of transvaginal ultrasound images by a study participant, with no previous training, in her home when guided by real-time remote supervision from a qualified and specially trained ultrasound technologist.

In addition to the main questions of the SELF-GYN1 study, additional questions related to patient decision-making and pricing dynamics for patients who purchase patient's decisions to purchase a fertility consult alongside enrolling in the SELF-GYN1 trial, will be studied at Mayo Clinic, through providing subsidies for the purchasing of the fertility consult.

Eligibility Criteria:
Inclusion Criteria:

* All inclusion criteria from the SELF-GYN1 trial apply
* Participant in Mayo Clinic health system
* Lives in MN
* Belongs to a sub-population targeted for enrollment that has not yet met its enrollment target
* Consent to participate in electronic health record monitoring and outreach

Exclusion Criteria:

* All exclusion criteria from the SELF-GYN1 trial apply
* Planning to move away from MN in the next year
The Ratio of Femoral Vein Diameter to Femoral Artery Diameter to Predict Fluid Responsiveness in Children

The hypothesis of the study will be that the ratio of femoral vein diameter to femoral artery diameter will have correlation with fluid status in pediatrics.

Proper administration of intravenous fluids is an important part of treating circulatory failure in children and affects the clinical outcome of the management of the child's emergency. Giving a small amount of fluid will cause tissue hypoperfusion and worsen organ dysfunction and cause ischemia. On the other hand, excess fluid interferes with oxygen delivary, exacerbates treatment outcomes, increases complications, and extends both the length of the stay in intensive care and mortality. The use of bedside ultrasound by pediatric intensive care physicians has become so critical in recent years that it is now a component of physical examination in ICUs

Eligibility Criteria:
Inclusion Criteria:

* children with American society of anaesthesiologist physical status 1-2
* 2-10 years of age
* scheduled for elective surgery
* signs of moderate to severe dehydration

Exclusion Criteria:

* Patients with mild dehydration.
* Patients with history of significant comorbid conditions or previous laparotomy.
* Congenital heart disease.
* Heart failure.
* Disorder of venous return like arteriovenous fistula, DVT or Varicose veins.
* Increase intra-abdominal pressure.
Safety and Immunogenicity of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)

This study is designed to evaluate the safety and immunogenicity of new formulations of GSK Biologicals' DTPa-HBV-IPV/Hib vaccine (GSK217744) when administered as a primary vaccination course to healthy infants at 2, 3 and 4 months of age.

This Protocol Posting has been updated following Protocol Amendment 1, February 2011, leading to the update of the exclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

* A male or female between, and including, 60 and 90 days of age at the time of the first vaccination.
* Born after a gestation period of 37 to 42 weeks inclusive.
* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
* Written informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Child in care.
* Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
* Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period, with the exception of oral rotavirus vaccination which is allowed at any time during the study.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, Hib and/or pneumococcal vaccination or disease, with the exception of hepatitis B vaccination at birth.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Family history of congenital or hereditary immunodeficiency.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
* Major congenital defects or serious chronic illness.
* History of any neurological disorders or seizures.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Acute disease and/or fever at the time of enrolment.
Pharmacokinetic and Pharmacodynamic Assessment of a Novel, Pharmaceutical Lipid-Aspirin Complex

Prospective, Randomized, Crossover, Bioequivalence study

Active-control crossover study randomizing 32 healthy volunteers to receive one of two dose levels, 325 mg or 650 mg, of either PL-ASA or immediate release aspirin within a two week washout period between treatments. The primary objectives are to assess PK and PD bioequivalence and safety over a twenty four hour period for PL-ASA and immediate release aspirin at 325 mg and 650 mg dose strengths.

Eligibility Criteria:
Inclusion Criteria:

* If female and of childbearing potential, subject has a negative pregnancy test and is not nursing.
* If female and of childbearing potential, subject is using adequate birth control for the duration of the study.
* Subject is able to understand and comply with study procedures.
* Subject is a non-smoker.
* Subject consumes no more than 1 alcoholic drink per day.
* Subject agrees to refrain from alcohol consumption for 48 hours prior to each drug administration and 48 hours after each drug administration.
* Subject is able and willing to provide written informed consent prior to any study procedures being performed.

Exclusion Criteria:

* Subject has abnormal screening/baseline laboratory parameters deemed to be clinically significant by the Investigator.
* Subject has taken any prescription medications other than hormone replacement therapy or thyroid replacement hormones within 3 days prior to drug administration.
* Subject has taken any of the following medications within 2 weeks prior to study entry:

  * NSAIDs or other medications for pain, including aspirin or aspirin containing products and acetaminophen (see Appendix B of protocol in Appendix 16.1.1)
  * Proton pump inhibitors, including Prilosec®, Prevacid®, Aciphex®, Protonix®, or Nexium®
  * H-2 blockers, including Tagamet®, Zantac®, Axid®, or Pepcid®
  * Any antiplatelet agent, including Plavix®, Ticlid®, Pletal®, ReoPro®, Integrilin®, Aggrastat®, or Persantine®
  * Any anti-coagulant, including Coumadin®, Acenocoumarol, Phenprocoumon, Phenindione, Heparin, Exanta®, Argatroban, Lepirudin, Hirudin or Bivalirudin
* Subject has used an investigational agent within the past 30 days.
* Subject has hypersensitivity or contraindications to aspirin, ibuprofen, or other NSAID.
* Subject has sensitivity to lecithin.
* Subject has a history of gastrointestinal problems including ulcers, frequent indigestion, or heartburn.
* Subject has a history of stroke, myocardial infarction, or congestive heart failure.
* Subject has a history of asthma, other bronchospastic activity, nasal polyps, or angioedema other than resolved childhood asthma.
* Subject has a history of kidney or liver disease.
* Subject has a history of thrombocytopenia, neutropenia, or bleeding disorder.
* Subject has a history of coronary arterial bypass.
* Subject has a history of non-trauma related hemorrhage.
* Subject has a history of chronic hypertension.
* Subject is currently enrolled in another investigational trial.
* Subject's platelets are unresponsive to arachidonic acid
Losartan Modulates Neural Responses to Looming Visual Stimuli: An Eye-tracking Study

The main aim of the present study is to investigate the effects of orally administered losartan on the perception of time-to-collision of threatening and non-threatening stimuli by combining a validated looming fear eye-tracking paradigm with a randomized between-subject placebo-controlled pharmacological trial design.

Animal models and initial findings in humans suggest a role of the angiotensin II antagonist losartan in socio- emotional processes. At the same time, the visual system's remarkable ability to perceive and interpret impending threats, notably through the "looming" phenomenon- a distinct pattern of optical expansion on the retina as objects approach, theoretically allows for precise estimation of the time-to-collision (TTC). It was demonstrated that the affective content of looming stimuli influences perceived TTC, with threatening objects judged as approaching sooner than non-threatening objects, hinting at a nuanced interaction between emotional valence and temporal perception. Within this context the present study aims to examine whether angiotensin II blockade via Losartan modulates the perception of time-to-collision towards threatening and non-threatening stimuli. To this end, healthy individuals will undergo a double-blind, between-subjects, placebo-controlled pharmaco-eye-tracking experiment and receive a single oral dose of losartan (50 mg) or placebo before performing a looming fear task 90 minutes after administration. The task paradigm will encompass threatening (butterfly, rabbit) and non-social (spider, snake) stimuli to examine the emotion-specific effects of losartan.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects who volunteer to participate and are able to fully understand and agree with this study by written informed consent.
* Normal or corrected-normal version

Exclusion Criteria:

* History of neuropsychiatric diseases.
* History of cardiac disease, including arrhythmias, aortic stenosis, or congestive heart failure; history of syncope or unexplained loss of consciousness.
* History of hepatic diseases, including cholestasis, biliary obstructive disease, or severe liver dysfunction.
* History of renal diseases, including renal stones or renal failure.
* History of hyponatremia(Serum sodium \<135mmol/L) or hyperkalemia (Serum potassium\>5.5mmol/L); history of diabetes mellitus or diabetes insipidus
* Known hypersensitivity or allergic reaction to any medication or hormone; strong allergic reaction to food.
* Infections such as COVID-19 or influenza, or unexplained fever.
* Subjects with hypertension (BP ≥130/80mmHg) or hypotension (BP ≤ 90/60mmHg).
* History of alcohol or drug abuse; smoker (≥ 10 cigarettes or ≥ 3 cigars or ≥ 3 pipes/day); smoker using e-cigarettes.
* Blood donation (≤ 1 month prior to administration).
* Take oral contraceptives or receive hormonal medications in the three months prior to the experiment.
Comparison Of External Physical Vibration Lithecbole(EPVL) In Different Time After Retrograde Intrarenal Surgery(RIRS)

The treatment of renal calculus by retrograde intrarenal surgery(RIRS) isn't able to eliminate stone completely

To evaluate the efficacy and safety of external physical vibration lithecbole for the treatment of residual stone in different time (3 days ,7 days and 14 days) after the operation of RIRS

Eligibility Criteria:
Inclusion Criteria:

1.Age of 18-75 years;

Exclusion Criteria:

1.Urinary tract anomalies, stricture or obstruction;
Effect of the Kv7-channel Opener Flupirtine on the Excitability of Human Peripheral Myelinated Axons in Vivo

Slow axonal Kv7 potassium channels are found along unmyelinated axons and at the nodes of Ranvier of myelinated axons in peripheral nerve. As such the pharmacological activation of Kv7 channels offers a potential means of reducing the excitability of peripheral axons. To determine whether this is the case for human peripheral myelinated axons, the effect of the Kv7 channel agonist flupirtine on the electrical excitability of A fibres was examined in both isolated segments of human sural nerve in vitro and in motor axons of the median nerve supplying abductor pollicus brevis in vivo. Axonal excitability was assessed in 21 human sural nerve fascicles in vitro and in 20 volunteers in vivo using threshold tracking in QTRAC (© Institute of Neurology, London, UK). Strength-duration time constant, rheobase current, relative refractory period (RRP), post spike superexcitability at 5 and 7 ms and threshold electrotonus over the 90 100 ms period were used as indices of electrical excitability. In addition, suppression of ectopic discharge in a model of upper limb ischaemia.


Eligibility Criteria:
Inclusion Criteria:

* voluntarily
* age \> 18 years old

Exclusion Criteria:

* current use of medication (e.g. analgetics, antiepileptics, antidepressants, etc.)
* prevailing organic disease (e.g. diabetes, vascular or neurologic illness, etc.)
* previous physical trauma of the forearm (e.g. burning, surgery)
* primary organ failure
* pregnancy and lactation
Observational Registry to Assess the Durability of Effect of CXL in Patients With Corneal Ectasia After Refractive Surgery

The objectives of this post market registry are to evaluate the safety and durability of treatment effect up to 3 years following cross-linking performed with Photrexa Viscous (riboflavin 5'- phosphate in 20% dextran ophthalmic solution), Photrexa (riboflavin 5'- phosphate ophthalmic solution), and the KXL System in patients with corneal ectasia following refractive surgery.

Approximately 200 patients who are planning to undergo or have undergone CXL for the treatment of corneal ectasia following refractive surgery in one or both eyes according to the prescribing information in the Photrexa Viscous and Photrexa Package Insert could be enrolled. Patients will be followed for safety and effectiveness at Months 3, 6, 12, 24 and 36 following cross-linking treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Be at least 18 years of age, male or female, of any race;
2. Provide written informed consent and sign a HIPAA form;
3. Willingness and ability to follow all instructions and comply with schedule for study visits;
4. Have a diagnosis of corneal ectasia post-refractive surgery (such as LASIK, PRK);
5. Planning to undergo (or have undergone within the past 90 days) corneal collagen cross-linking with PHOTREXA VISCOUS/ PHOTREXA and the KXL System, per the prescribing information (NOTE: Complete treatment and follow-up data, including any product-related events at time of procedure through the time of enrollment must be available);
6. For females capable of becoming pregnant, agree to have urine pregnancy testing performed prior to enrolling in the registry; must not be pregnant or lactating.

Exclusion Criteria:

1. If female, be pregnant, nursing, or have a positive urine pregnancy test prior to enrollment in the registry;
2. The Investigator may exclude or discontinue any patient for any sound medical reason.