cyrilzakka/clinical-trials huggingface dataset:
Comparison of Lotrafilcon B Lenses With Different Packaging Solutions

The purpose of this study is to evaluate AIR OPTIX® plus HYDRAGLYDE® (AOHG) contact lenses compared to AIR OPTIX® AQUA (AOA) contact lenses in overall lens fit.

Subjects must not wear any contact lenses prior to the visit on Day 1 (Insertion) for Period 1 or Day 1 (Insertion) for Period 2.

Eligibility Criteria:
Inclusion Criteria:

* Must sign Informed Consent Document;
* Manifest cylinder less than or equal to 0.75 Diopter (D) in each eye;
* Successful current wearer (during the past 2 months for a minimum of 5 days per week and 8 hours per day) of AOA contact lenses within the protocol-specified power range;
* Willing to answer text messages on a daily basis during the study;
* Willing to discontinue artificial tears and rewetting drops on the days of study visits;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Habitual lens wear in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week);
* Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current);
* History of herpetic keratitis, corneal surgery or irregular cornea;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
* Monocular (only 1 eye with functional vision) or fit with only 1 lens;
* Pregnant or lactating;
* Participation in any clinical study within 30 days of Visit 1;
* Other protocol-specified exclusion criteria may apply.
CPL-01 in the Management of Postoperative Pain After Bunionectomy

Subjects receive study drug during bunionectomy and are followed for pain and opioid use, with the hypothesis that those who receive CPL-01 will have less pain and less opioid use than either control arm.

After signing informed consent, subjects will be randomly assigned to receive study drug (either Investigational product, positive control, or negative control) during unilateral distal bunionectomy with osteotomy. Subjects will then remain at the hospital for 72-hours where pain and rescue medication usage will be assessed. Follow-up will then occur at 7 and 30 days afterwards.

The hypothesis is that subjects who receive CPL-01 will have less pain and require fewer opioids than subjects in the other two arms.

Eligibility Criteria:
Inclusion Criteria:

* Ability to sign ICF
* Bunion for elective primary unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia, without collateral procedures or additional surgeries
* BMI ≤ 39 kg/m2
* If biologically female, not pregnant or planning to become pregnant over the study
* If biologically male, either sterile or using acceptable form of birth control
* Be willing and able to complete study procedures

Exclusion Criteria:

* Has previously undergone unilateral simple bunionectomy.
* Has a planned concurrent surgical procedure
* Has a concurrent painful condition that may require analgesic treatment during the study period or may confound postsurgical pain assessments
* Has a history or clinical manifestation of significant medical, neuropsychiatric, or other condition that could preclude or impair study participation or interfere with study assessments.
* Has a history of malignant hyperthermia or glucose-6-phosphate dehydrogenase deficiency.
* Has history or evidence of impaired liver function (e.g., alanine aminotransferase \[ALT\] \> 3 × upper limit of normal \[ULN\] or total bilirubin \> 2 × ULN), active hepatic disease, or cirrhosis.
* Has history or evidence of impaired renal function (e.g., creatinine \> 1.5 × ULN).
* Has a history of malignancy in the past year
* Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months
Lipiodol-TACE With Idarubicin for Hepatocellular Carcinoma

The purpose of this real-world study is to evaluate the safety and efficacy of lipiodol-TACE with idarubicin for hepatocellular carcinoma.

Idarubicin is a DNA topoisomerase II inhibitor that promotes DNA strand breakage, trapping cells in the G2 phase of the cell cycle and inducing DNA cleavage and cell apoptosis. At the same time, it can be inserted between the DNA base pairs and produce free radicals, thus breaking the DNA double helix structure and inhibiting the extension, replication and transcription of DNA strands. Preclinical studies have shown that idarubicin has higher antitumor activity than epirubicin, especially against SUN-449 human hepatoma cells. In recent years, domestic and foreign scholars have conducted a series of explorations in the treatment of hepatocellular carcinoma with lipiodol-idarubicin emulsion, and have obtained positive results. This proepective， multicenter real-worldstudy aims to evaluate the efficacy and safety of lipiodol-TACE with idarubicin in Chinese HCC patients.

Eligibility Criteria:
Inclusion Criteria:

1).18-75 years old; no gender limit; 2).Confirmed diagnosis of HCC according to histopathology or CNLC guidelines (2019 Edition); 3）Life expectancy≥3 months; 4).Child-Pugh class A or B; 5).ECOG PS of 0 or 1;6).One of the following cases: CNLC stage IIb and IIIa; CNLC stage Ib and IIa patient who is unable or unwilling to receive surgical treatment due to other reasons (such as advanced age, severe liver cirrhosis, etc.); The main portal vein has not been completely obstructed, with abundant collateral vessels, or restore the blood flow by portal vein stent placement; 7). At least one measurable lesion (the length diameter≥10mm); 8).Laboratory indices: WBC≥3.0×109/L; PLT≥50×109/L; Hb≥70g/L; Cr≤1.5×UNL(upper limit of normal); BIL≤2.0×UNL, ALT≤5.0×UNL, AST≤5.0×UNL.

Exclusion Criteria:

1).The coagulation function is severely decreased and cannot be recovered; 2).The main portal vein is completely embolized by cancer embolism, with few collateral vessels; 3).With active hepatitis or severe infection that cannot be treated at the same time; 4). With cachexia or multiple organ failure; 5). With uncontrollable neurological and mental disorders, or poor compliance; 6.) Primary brain tumors or central nervous system metastasis has not been controlled, with obvious intracranial hypertension or neuropsychiatric symptoms; 7). Pregnant or breast feeding women; 8). Received drug treatments in other clinical trial in the past 4 weeks; 9). Other situations where the investigators judge that the patient should not participate in.
Ampicillin and Ceftriaxone for the Treatment of Enterococcus Faecalis Infective Endocarditis.

Phase IV, open-label, randomized and multicenter clinical trial to prove that patients with Enterococcus faecalis infective endocarditis treated with an antibiotic treatment as a continuous infusion is non-inferior to the standard intermittent infusion regimen, usually administered in hospitalized patients.

The aim of the study is to prove that the continuous infusion of antibiotic treatment for the patients with Enterococcus faecalis infective endocarditis is as effective and safe as the traditional intermittent infusion. The continuous infusion modality of treatment is expected to provide numerous benefits for individual patients, global health, and for the National Health Care System by reducing to hospital stays from 4-6 weeks to approximately 2-3 weeks and hospital-driven complications.

The mortality, rate of serious adverse events, total number of days of antibiotic treatment and days of hospitalization, among others, are included as secondary objectives.

This is a pragmatic study as the number or visits performed for the study are similar to the normal clinical follow-up for this patients. Final contact and final visit for the study will be performed at 365 days after the 42 days of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Possible or definitive diagnosis of infective endocarditis due to Enterococcus faecalis
* Signed informed consent of patients

Exclusion Criteria:

* Allergy to penicillins or cephalosporins
* Pregnancy and lactation
* Polymicrobial infection including microorganisms different to E. faecalis
A Study of Gene Edited Autologous Neoantigen Targeted TCR T Cells With or Without Anti-PD-1 in Patients With Solid Tumors

This is a first in human, single arm, open label, Phase 1a/1b study to determine the safety, feasibility, and efficacy of a single dose of NeoTCR-P1 T cells in participants with solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented incurable or metastatic solid tumors of the following types: melanoma, UC, ovarian cancer, colorectal cancer, breast cancer (HR+), or prostate cancer.
* Disease has progressed after at least one available standard therapy or no additional curative therapies are available.
* Measurable disease per RECIST v1.1
* Eastern cooperative oncology group (ECOG) performance status of 0 or 1
* Adequate hematologic and end organ function determined within 30 days prior to enrollment.
* Disease-specific criteria related to the specific tumor type are required.

Note: There are additional inclusion criteria. The study center will determine if you meet all of the criteria.

Exclusion Criteria:

* Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, and/or inherited liver disease
* Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases
* Uncontrolled or symptomatic hypercalcemia
* Pregnancy, lactation, or breastfeeding
* Prior allogeneic stem cell transplant or solid organ transplant
* Prior chimeric antigen receptor therapy or other genetically modified T cell therapy
* Active HIV, Hepatitis B, or Hepatitis C infection
* Active tuberculosis
* Severe infection within 2 weeks prior to enrollment
* Major surgical procedure within 4 weeks prior to enrollment or anticipation of need for a major surgical procedure during the study.

Note: There are additional exclusion criteria. The study center will determine if you meet all of the criteria.
Text4Vax: Text Message Reminders for Pediatric COVID-19 and Influenza Vaccines 2024-25 Season

This multi-site study assesses the impact of text message reminders on the receipt of COVID-19 and influenza text message reminders takes place primarily in practices from the American Academy of Pediatrics (AAP) Pediatric Research in Office Settings (PROS) network.

The study is to be conducted over the 1st season (September 2024-April 2025) as an effectiveness trial and the 2nd (September 2025-April 2026) as a replication study. This protocol covers the first season. Parents of eligible children who are 6 month-17 year-old who are due for both a COVID-19 and influenza vaccine will be sent text messages. Within each practice site, parents of eligible children will be randomized to receive either: 1) combined COVID-19 and influenza vaccine text message reminders, 2) COVID-19 reminders alone, 3) influenza reminders alone, or 4) no reminders (usual care).

Randomization is to be stratified by practice site, age group and prior year's COVID-19/influenza vaccine history. Messages will be sent centrally and managed by the research team.

Eligibility Criteria:
Inclusion Criteria:

* Child that:

  * is 6 months-17 year-old children
  * due for both a COVID-19 and influenza vaccine
* Receives care at study site
* Language listed in electronic health record is English or Spanish
* Has not opted out of text messages from practice

Exclusion Criteria:

* Has opted out of text messages from practice
* Language listed in electronic health record is not English or Spanish
Trigeminal Brainstem Mapping

To what extent the somatotopy of the 3 branches of the trigeminal nerve (V1,V2,V3) as well as the greater occipital nerve (GON) in the brainstem but also in the thalamus and the insula can be mapped using functional imaging and BOLD in humans is not known but might play an important role in imaging headache diseases. The aim is to map their somatotopy by random stimulation of V1, V2, V3 and the GON with painful electrical input during acquisition of BOLD-fMRI.


Eligibility Criteria:
Inclusion Criteria:

* healthy
* suitable fo MRI

Exclusion Criteria:

* headache disease
* psychological disorder
* pregnancy
* all exclusion criteria necessary for imaging in a 3 T MRI scanner
A Web-based Observational Study of Patient-reported Outcomes in Adults With Narcolepsy

Nexus is a collaboration between academic institutions, advocacy and industry to answer important questions about narcolepsy. It is a web-based observational study of patient-reported outcomes in adult patients with narcolepsy, with follow-up every six months.

Nexus website: www.narcolepsyregistry.com


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Diagnosed with narcolepsy by a doctor
Correction of Lower Limb Deformities With Fixator Assisted Nailing

It is a retrospective study at a tertiary care hospital. All cases of lower limb deformity whose correction was done with fixator assisted IM nailing from 2010 till 2017 were analyzed.

It is a retrospective study at a tertiary care hospital. All cases of lower limb deformity whose correction was done with fixator assisted IM nailing from 2010 till 2017 were analyzed. Pre Op x-rays and post op x rays will be analyzed for Mechanical Axis Deviation (MAD), anatomical Lateral Distal Femoral Angle (aLDFA), mechanical Lateral Distal Femoral Angle (mLDFA) and Medial Proximal Tibial Angle (MPTA), post-operative activity and functional status of the patients. Data will be analyzed using SPSS

Eligibility Criteria:
Inclusion Criteria:

- All those patients who underwent fixator assisted intramedullary nailing of tibia or femurs for deformity correction were included

Exclusion Criteria:

* Patients who lost to follow up and those with missing records were excluded from the study.
tSMS in Essential Tremor

This is randomized double-blind study to study the hypothesis that transcranial static magnetic field stimulation of the primary motor cortex improves tremor in patients with essential tremor. Half of the patients will receive tSMS of the left hemisphere and the other half of the right hemisphere.


Eligibility Criteria:
Inclusion Criteria:

* Essential tremor

Exclusion Criteria:

* MRI-incompatible metal objects in the body (e.g. cardiac pacemakers)
* other main neuropsychiatric co-morbidity
* pregnancy
Evaluation of Video Laryngoscopes in Difficult Airway

In this multicenter study the investigators are going to evaluate the use of six different videolaryngoscopes in patients undergoing elective surgery requiring general anesthesia with intubation. The investigators are hypothesizing that these six videolaryngoscopes will succeed for intubation at first attempt in at least 90% of all cases using a difficult airway simulation with extrication collars. As gold standard, a standard Macintosh blade is being used.

The study consists of 6 arms. Each arm includes 120 patients, sums up to a total of 720 patients.


Eligibility Criteria:
Inclusion Criteria:

* elective surgery with general anesthesia requiring intubation
* \>18years old
* ASA I-III

Exclusion Criteria:

* known or presumed difficult airway
* risk of pulmonary aspiration
* refusing to participate
Reducing Alcohol Dependence Among HIV-Positive Individuals

The purpose of this study is to compare the effects of interventions for drinking-reduction and antiretroviral therapy (ART) adherence among HIV-positive primary care patients. The interventions consist of brief meetings to discuss drinking and ART adherence enhanced with daily self-monitoring through the use of a smart phone application that tracks drinking and other aspects of health. These meetings will either be based on the Clinician's Guide, a brief intervention for heavy drinking in primary care settings advocated by the National Institute on Alcohol Abuse and Alcoholism, or Motivational Interviewing. Participants will be assessed at baseline, 30, 60, 90 days, 6 and 12 months after baseline. By the end of treatment (60 days) and throughout the follow-up period, alcohol use is expected to highest among participants who receive the Clinician's Guide alone, intermediate among participants who receive the enhanced Clinician's Guide, and lowest among participants who receive enhanced Motivational Interviewing.

HIV infection is a widespread health problem in the U.S. Antiretroviral (ART) therapy has increased longevity and changed the nature of risk factors for morbidity and mortality. Alcohol consumption has become an increasingly serious health issue among HIV primary care patients. Drinking is a key factor in progression to severe liver damage (especially those co-infected with hepatitis), and liver disease is now one of the most common causes of death among those with HIV. Excess drinking is also associated with medication noncompliance, reduces the effect of antiretroviral treatment, and is linked to other health problems. Therefore, helping HIV patients reduce unsafe drinking is crucial to their long-term health. This study aims to evaluate two evidence-based approaches when combined with an innovative smart phone application designed to help users track drinking and other aspects of health. An effective, easily implemented alcohol-reduction intervention could be incorporated into standard care in HIV clinics to help prevent or slow the progress of some medical problems in HIV-infected individuals, improve medication compliance, prolong lifespan and decrease risk behavior associated with alcohol use.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Patient had 4 or more drinks on any day in prior 30 days
* Patient meets criteria for DSM-IV current alcohol dependence
* HIV+

Exclusion Criteria:

* Patient is psychotic, suicidal, or homicidal
* Patient has gross cognitive impairment
* Patient does not speak English or Spanish
* Patient has plans to leave the greater New York metropolitan area within the study period
* Patient has vision/hearing impairment that would preclude participation
Impact of Walking Aids on the Occurrence of Carpal Tunnel Syndrome in Rehabilitation

The purpose of this study is to assess the impact of the use of technical walking aids in the adult population undergoing rehabilitation by evaluating clinical, electrophysiological, and iconographic parameters before and after the use of these devices.

The current evidence indicates that the short-term use of walking aids elicits pressure-induced anatomical changes of the median nerve and that long-term use of walking aids leads to a significant percentage of stroke patients developing clinical symptoms of carpal tunnel syndrome. We will investigate the consequences of using technical walking aids for gait in a broader population of rehabilitation patients. The rehabilitation setting per se may be considered a useful clinical 'human pathological model' for peripheral nerve entrapment. Recruited patients will be naïve to previous use of walking aids and de novo will start using them for gait rehabilitation, regardless of the underlying disease. This intervention model will allow us to identify clinical, electrophysiological, and anatomical changes of the median nerve due to the daily direct pressure elicited by walking aids. We consider that a one-month duration of use of walking aids is needed to observe detectable changes in electrophysiological and ultrasonographical assessment to elicit entrapment neuropathies in patients prone to developing them.

Eligibility Criteria:
Inclusion Criteria:

* admitted into an in-patient rehabilitation unit
* Functional Ambulation Category ≥ 1
* de novo need for a walking aid
* at least one functional upper limb
* expected duration of need for walking aid at least one month

Exclusion Criteria:

* less than 18 years old
* current use of walking aid or use of a walking aid less than 6 months ago)
* difficulty filling out questionnaires or understanding instructions in French
* medical contraindications to the use of walking aids
* refusal to sign the consent form.
Prognostic Role of Bowel Ultrasound Scan in Children Affected by Acute Severe Colitis

ASC is a life-threatening medical emergency. The lack of a timely intervention has shown to be associated with a mortality rate higher than 20% in adults, whereas a prompt targeted therapy has displayed a decrease of the aforementioned rate to 1%. Therefore, the identification of predictors of poor outcome trough an objective tool may provide crucial help to individualize the timing of second line treatment initiation. At the state of the art, PUCAI represents the only validated tool to appraise the risk of first-line treatment failure and there is a lack of objective methods with a prognostic value in ASC.

BUS has proven to be a reliable tool in assessing disease activity in children with UC and it has also shown statistically significant correlation with endoscopic features of disease activity. Given the literature suggesting a role for BUS in severe UC and the results from our retrospective study we aim to validate our findings trough a prospective assessment of the potential prognostic role of BUS in ASC.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged \< 18 years hospitalized for ASC with diagnosis of UC established by the presence of accepted clinical, radiologic, endoscopic, and histologic criteria

Exclusion Criteria:

* Patients with infectious colitis;
* Patients undergoing treatment with anti-TNF alpha agents;
* Patients already enrolled during the study period for a previous ASC attack;
Long Term Trajectories of SMA Patients Receiving or Not Disease-modifying Treatments

This is an observational multicenter retrospective and prospective study on natural history of SMA also considering the 'new natural history' secondary to the availability of commercially available therapies.

All the patients enrolled to date in the Italian registry, if not part of clinical trials, will be included in the present study.

This is an observational multicenter retrospective and prospective study on natural history of SMA also considering the 'new natural history' secondary to the availability of commercially available therapies.

All patients affected by Spinal Muscular Atrophy 5q, irrespective of genotype, phenotype, age, treatment status or gender will be enrolled in the study .

The study aims to i) better understand the natural history of the disease in untreated patients in terms of functional aspects, concomitant illnesses, quality of life ii) describe the patterns of disease progression in treated and untreated patients in terms of functional aspects, concomitant illnesses, quality of life iii) Describe all the patients treated with the available therapies in Italy, in terms of demographic (age, location etc..) and epidemiological data All data from patients included in the study will be collected at each visit, following the clinical care protocols of each centre. Following care recommendation patients are generally routinely assessed at least every 6 months and, in many cases, every 4 months.

We plan to obtain

* Longitudinal changes in untreated patients: The possibility to access reliable retrospective data will provide the opportunity to record long term functional data in untreated patients.
* Yearly analysis of longitudinal changes in treated patients:
* Two-year results of the validation of new measures (SMA HI, SMAIS): reporting the validation process (inter- and intra-observer reliability, internal consistency) and changes in relation to functional measures

Eligibility Criteria:
Inclusion Criteria:

all patients with mutationsin the SMAN1 gene

Exclusion Criteria:

unable to proviude consent