cyrilzakka/clinical-trials huggingface dataset:
Effect of Trigeminal Nerve Stimulation on Corneal Nerves and Chronic Ocular Pain

Individuals with dry eye tend to present with ocular pain which persists despite the use of topical treatment. This could be secondary to somatosensory impairment attributable to neuropathic pain. The purpose of this study is to evaluate the effect of trigeminal nerve stimulation (TNS) on corneal nerves and chronic ocular pain in patients with dry eye.

Dry eye is a multifactorial disease that produces a variety of clinical manifestations including, dryness, pain, blurred vision, and sensitivity to light or wind. Differences have been noted between the symptoms reported and the signs presented on physical examination, which suggests the involvement of somatosensory impairment. Ocular neuropathic pain is characterized by burning pain, hyperalgesia, photophobia, and sensitivity to wind. There are common physiopathological pathways, suggesting that corneal nerve sensitization contributes to the development of dry eye symptoms. Furthermore, in vivo confocal microscopy has reported a decrease in the density of the subbasal plexus in patients with a neuropathic component and dry eye, suggesting that they are not mutually exclusive conditions. Various topical treatments, as well as systemic medications are known to manage eye pain and dry eye. However, in some cases, individuals have been refractory to them, enhancing the importance of research in adjuvant therapies such as TNS.

This research protocol evaluates the effect of transcutaneous stimulation on corneal subbasal plexus density and chronic eye pain in patients with dry eye. A complete dry eye examination will be performed, including completion of Ocular Surface Disease Index (OSDI) and Dry Eye Questionnaire-5 (DEQ-5). Subbasal nerves density will be measured by confocal microscopy before and after receiving treatment with TNS. In addition, monthly monitoring of the intensity of ocular pain (with a numerical scale of 0-10) will be maintained. The intensity and severity of the clinical variables will be compared before and after receiving the treatment with a paired t-test considering a value of p\<0.05 as statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with dry eye, Ocular pain for more than 3 months, Contact lens users, Individuals using topical treatment and/or systemic medication for dry eye syndrome, Individuals with history of photo-ablative ocular surgery (Laser-assisted in situ keratomileusis (LASIK) , Photorefractive keratectomy (PRK), Small incision lenticule extraction(SMILE), Individuals with history of autoimmune disease (Lupus, Rheumatoid Arthritis, Sjögrens),

Exclusion Criteria:

* Individuals with pacemakers or implantable defibrillators, Individuals with diagnosis of epilepsy, History of facial trauma one month prior to recruitment, Acute facial pain with unknown etiology, History of ocular surgery one month prior to recruitment, Trigeminal neuralgia, Active Herpes Zoster Ophthalmicus,
Identification of Acute Intermittent Porphyria Modifying Genes

This study proposes to identify the predisposing/protective modifying genes that underlie the acute attacks in symptomatic patients with Acute Intermittent Porphyria (AIP), an autosomal dominant inborn error of heme biosynthesis.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give informed consent
* 12 years of age or older
* Willingness to provide blood/saliva and urine samples, and clinical information
* A member of an AIP family, defined as (must meet one of the following):

  1. proband: possesses an AIP pathogenic mutation and is/has been symptomatic (experienced acute attacks in the opinion of the investigator)
  2. Parents (no known HMBS mutations or heterozygote with familial mutation)
  3. First, second, or third degree relative of (a) or (b)
Comparison of Clinical Outcomes After Cataract Surgery With and Without Capsular Tension Ring

This study was set up to identify clinical outcomes including a refractive shift or change in IOL calculation accuracy and optical quality after Ophtec® capsular tension ring in the eyes without zonular instability.


Eligibility Criteria:
Inclusion Criteria:

1. age between 40 and 79 years
2. no history of eye surgery or glaucoma
3. a transparent central cornea
4. pupil dilation at the preoperative examination of at least 6.0 mm
5. absence of biomicroscopic signs of pseudoexfoliation
6. normal fundus examination

Exclusion Criteria:

1. presence of ocular disease that might affect the visual outcome (e.g., color vision disturbance, chronic uveitis)
2. presence of ocular disease that might affect contrast sensitivity function (e.g., glaucoma, maculopathy, high myopia)
Effects of Micronized Fenofibrate on Fasting and Postprandial Lipoproteins, Inflammatory Mediators and Thrombosis

This is a randomized placebo controlled clinical trial designed to investigate the effects of micronized fenofibrate on fasting and postprandial lipoproteins, oxidized fatty acids and lipoproteins, inflammatory mediators and thrombotic factors among hypertriglyceridemic individuals with two or more other characteristics of the metabolic syndrome.

The aim of this study was to determine the effects of micronized fenofibrate (160 mg/daily) on:

1. Fasting and postprandial lipids and lipoproteins after a standarized test meal.
2. Fasting and postprandial oxidized fatty acids and oxidized low density lipoprotein after a standarized test meal.
3. Fasting and postprandial inflammatory mediators after a standarized test meal.
4. Fasting and postprandial lipopolysaccharide-stimulated cytokine production after a standarized test meal.
5. Fasting and postprandial markers of hemostasis, fibrinolysis and blood viscosity after a standarized test meal.

Eligibility Criteria:
Inclusion Criteria:

1. males and postmenopausal females 18 years of age with fasting triglycerides greater than or equal to 1.7 mmol/L and \<6.9 mmol/L
2. two or more of the following Adult Treatment Panel III (1) criteria of the metabolic syndrome: abdominal obesity (waist circumference \>89 cm in females and \>102 cm in males); low high-density lipoprotein cholesterol (HDL-C) (\<1.3 mmol/L in women and \<1.0 mmol/L in men); hypertension (systolic blood pressure \>130 or diastolic blood pressure \>85 mm Hg) or current drug therapy for hypertension; and impaired fasting glucose (between 6.1 mmol/L and 7.0 mmol/L).

Exclusion Criteria:

1. included types 1 or 2 diabetes
2. Body mass index \>40 kg/m2
3. Use of lipid-lowering therapies
4. Oral hypoglycemic therapies
5. Insulin
6. Aspirin \>81 mg daily
7. Regular use of non-steroidal anti-inflammatory agents or cyclooxygenase-2 inhibitors, corticosteroids (oral and inhaled), anti-oxidants (including multivitamins), herbal or fiber supplements recent changes in type or formulation of hormone replacement therapy (in the last 6 months)
8. Alcohol intake \>3 drinks per day
9. Untreated hypothyroidism or recent change (within 2 months) of thyroid replacement therapy
10. Cigarette smoking (current or within the last 6 months)
Study to Eliminate Hib Carriage in Rural Alaska Native Villages

Hib disease rates in rural Alaska before introduction of HIb conjugate vaccine were among the highest in the world. Since vaccine introduction, rates have fallen by 90% but the disease has not been eliminated. This study is designed to test one possible means of eliminating Hib carriage and thus to eliminate person to person transmission and invasive disease.

The objective of this study is to evaluate the effectiveness of community-wide use of Hib conjugate vaccine for eliminating oropharyngeal Hib carriage in rural Alaska villages.

Secondary objectives include:

* Determine risk factors for Hib OP carriage including demographic characteristics, and immunologic characteristics (antibody level and function). This will be accomplished through a case-control study described below.
* Measure antibody response to Hib conjugate vaccine among adults who have not previously received Hib vaccine. This will be accomplished through a cohort study of participating adults in the vaccine intervention communities.

This was a pilot intervention to assess the feasibility of using Hib conjugate vaccine to eliminate Hib carriage in rural Alaska villages, with three villages to serve as a comparison group. WE performed community-wide surveys of Hib carriage by recruiting volunteers for throat cultures to establish a baseline rate of Hib carriage for each community. Then Hib carriers were offered chemoprophylaxis to clear Hib from their throats. In the vaccine intervention communities, a single dose of Hib conjugate vaccine was offered to persons of all ages. This was followed by a second community-wide Hib carriage survey after one year to assess the effectiveness of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* All village residents are eligible for Hib colonization survey
* All residents of selected villages eligible for vaccine study except as noted below.

Exclusion Criteria:

* For receipt of vaccine:
* history of allergic reaction to Hib vaccine or components
* Age \< 24 months and not due for Hib vaccine according to childhood immunization schedule
* Age \> 24 months and have received HIb vaccine within past year
* Pregnant
Prognostic Immune Biomarkers in HNSCC

Evaluation of the prognostic potential of tumor-infiltrating lymphocytes and PD-L1 expression in non-metastatic squamous cell carcinoma of the head and neck

The role of the immune system in the process of tumor growth and progression in head and neck (HaN) cancer has become of increasing importance. In the last years, the concept of tumor immune microenvironment (TIME) with the presence of tumor cells (TC) and infiltrating immune cells (IC) has been intensively studied. The results of available clinical studies suggest a positive impact of tumor-infiltrating lymphocytes (TILs) on the prognosis of HNSCC patients and their overall (OS) and cancer specific survivals. Beside TILs, an integral component of TIME is the immunosuppressive activity represented by inhibitory signalling molecules expressed on tumor cells (TCs) and immune cells (ICs).

One of these molecules is programmed death-ligand 1 (PD-L1), which inhibits the cytotoxic immune response mediated by T-lymphocytes.

The aim of this observational cohort study is to assess the prognostic potential of novel immune biomarkers in patients with HNSCC tumors stage I-IVb treated with radical radiotherapy and radiochemotherapy. Specifically, the association between high and low TILs infiltration and OS and cancer specific survival parameters will be investigated. As well as the association between high and low PD-L1 expression and OS and cancer specific survival parameters will be investigated.

This is a non-interventional study conducted in one institution - Department of oncology, University hospital Ostrava. The tumor immunoprofile defined by the presence of immune biomarkers (TIL, PD-L1) will be evaluated in each patient from biopsy specimens in representative hematoxylin and eosin stained sections by immuno-histochemistry. The Cox proportional risk model will be used to estimate the prognostic potential of each of the biomarker.

Eligibility Criteria:
Inclusion Criteria:

* Patients with non-metastatic squamous-cell head and neck cancer (HNSCC) stage I-IVb indicated for curative/radical treatment
* Histologically verified squamous cell carcinoma including HPV-positive carcinomas
* Tumor site: oropharynx, larynx, hypopharynx, oral cavity, nasal cavity
* Treatment modality - radiotherapy or radiochemotherapy
* Presence of immune biomarkers in the tissue - tumor-infiltrating lymphocytes (TILs) and/or PD-L1 expression
* Sufficient data on patient follow-up

Exclusion Criteria:

* Histological type other than squamous cell carcinoma
* Paranasal sinus tumors, thyroid and nasopharyngeal carcinomas, salivary gland tumors, mucosal melanoma, skin carcinoma, lymphomas, and occult primary tumors
* Synchronous malignancies or recurrent disease
* The previous use of radiotherapy
* The presence of distant metastatic disease
* Missing or inadequate follow-up data
* The inability to evaluate biomarkers (TILs or PD-L1) in a histological tissue sample.
Antioxidant and Immune Effects of Vitamin K2

The aim of the study is to obtain insight into a dose-dependent effect of vitamin K2 on oxidative stress and specific markers of the immune system.


Eligibility Criteria:
Inclusion Criteria:

* Self-reported postmenopausal (at least one year after the final menstruation)
* BMI ≥25 and ≤32 kg/m2;
* Plasma dp-ucMGP concentration in highest 50-66% of the screened population
* Non-smoking, defined as not smoking currently and not having smoked (at all) in the year before study start;
* Healthy as assessed by the health questionnaire and according to the judgment of the study physician;
* Voluntary participation;
* Having given written informed consent;
* Willing to comply with study procedures;

Exclusion Criteria:

* Plasma dp-ucMGP concentration \>1000 pmol/L at screening
* Treatment with oral antibiotics within 2 months of the start of the study
* Any vaccination in the month before study start or any scheduled vaccination during the study period
* Use of antioxidant or vitamin K and D supplements;
* Use of antioxidant or vitamin K and D supplements in the month before the start of the study;
* Use of aspirin or medication with established antioxidant or anti-inflammatory properties;
* Use of medication that interferes with vitamin K or blood coagulation;
* Use of statins to reduce level of low-density lipoprotein cholesterol in the blood;
* Hyperlipidaemia, diabetes, hypertension, intestinal disease, diseases with an inflammation component;
* Hormone replacement therapy in women;
* Follow a vegetarian or vegan diet;
* Participation in any clinical trial including blood sampling and/or administration of substances up to 30 days before day 1 of this study;
* Alcohol consumption for men \> 28 units/week and \>4/day; for women: \>21 units/week and \>3/day;
* Reported unexpected weight loss or weight gain of \> 3 kg in the month prior to pre-study screening, or intention to lose weight during the study period;
* Reported slimming or medically prescribed diet;
* Recent blood donation (\<1 month prior to Day 01 of the study);
* Not willing to give up blood donation during the study;
Using a Sheathed Speculum to Visualize and Access the Cervix In Women With Excessive Vaginal Tissue

The main objective of the study is to assess the effectiveness of the sheathed speculum in providing adequate visualization and access to the cervix in patients with excessive vaginal tissue.

The secondary objective is to rate the patient's comfort evaluation during the sheathed speculum examination.

This is a descriptive clinical trial designed to assess the efficacy of a sheathed speculum in providing adequate visualization and access to the cervix in women with excessive vaginal tissue. Eligible, consented subjects who fail their initial speculum examination (because their cervix is not visualized due to the collapse of loose lateral vaginal walls) will have a sheathed speculum examination instead of the standard-of-care exam whereby the clinician fabricates a solution at the bedside (condom with tip cut placed on speculum, concomitantly using an additional instrument like a lateral-wall retractor, glove with tip of thumb placed over the speculum, using the largest speculum available)

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 64 years
* BMI greater than 30 (or see next line)
* Collapsing vaginal tissue preventing the visualization of the cervix (meeting this criterion in the absence of a BMI \>30 would also qualify the patient for the study).
* Able to provide written informed consent

Exclusion Criteria:

* Patients unwilling to participate in the study or provide consent Presence of significant acute pelvic pain syndromes (ie exacerbation of dyspareunia, chronic pelvic pain or pelvic floor dysfunction, atrophic vaginitis, interstitial cystitis, endometriosis) which, in the opinion of the examining clinician, could potentially confound the patient's responses to the questionnaire
* Presence of active genital herpes
* Presence of significant condyloma acuminata (may be an investigator decision)
* Any other patient deemed inappropriate for the study by the consenting or examining investigator.
OTO-313 in Subjects With Unilateral Subjective Tinnitus

The purpose of this study is to determine the efficacy of OTO-313 in subjects with unilateral tinnitus and to determine the safety and tolerability of OTO-313 in subjects with unilateral tinnitus.


Eligibility Criteria:
Inclusion Criteria:

* Subject has early-onset subjective unilateral tinnitus that is persistent (consistently aware of their tinnitus throughout much of the waking day).
* Subject is able to use the diary to complete their daily tinnitus ratings.
* Subject's tinnitus is likely of cochlear origin, e.g., associated with sensorineural hearing loss; acute hearing loss from noise trauma, barotrauma, or traumatic cochlear injury (acute acoustic trauma, blast trauma, middle ear surgery, inner ear barotrauma); age related hearing loss; resolved otitis media; ototoxic drug exposure.
* Subject is willing to comply with the protocol and attend all study visits.

Exclusion Criteria:

* Subject has pulsatile tinnitus, temporomandibular joint disease (TMJ) associated with tinnitus perception, tinnitus resulting from traumatic head or neck injury, or tinnitus resulting from a tumor or stroke.
* Subject is pregnant, lactating, or undergoing fertility treatment.
* Subject has other clinically significant illness, medical condition or medical history at Screening or Baseline that, in the Investigator's opinion, would likely reduce the safety of study participation or compliance with study procedures.
Evaluation of Nanodropper-mediated Microdrops vs. Standard Drops of 0.5% Timolol Maleate in Glaucoma Patients

The purpose of this study is to evaluate the effect of microdrops vs. standard eyedrops of 0.5% timolol maleate in adults with primary open-angle glaucoma or ocular hypertension in terms of intraocular pressure-lowering efficacy and cardiovascular side effects.

This randomized, single-masked, parallel study aims to evaluate the safety and efficacy of microdrops of 0.5% timolol maleate administered with Nanodropper (experimental intervention) compared to standard drops of 0.5% timolol maleate (active comparator) in patients with primary open-angle glaucoma (OAG) or ocular hypertension (OHT) at Aravind Eye Hospital. At the beginning of the test day, baseline (pre-drug) intraocular pressure (IOP), resting heart rate (HR), and resting systolic and diastolic blood pressure (BP) measurements will be collected. Participants will be randomized to receive standard eyedrops or microdrops of 0.5% timolol maleate (one drop per eye), which will be administered by a trained technician at t = 0. IOP, HR, and BP measurements will be repeated by a masked investigator at t = 1, 2, 5, and 8 hours after drug administration.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Recent diagnosis of primary OAG or OHT
* Treatment-naive (not currently using ophthalmic medication)
* Baseline IOP between 21-35 mm Hg
* Corrected Snellen visual acuity of 6/60 or better in each eye

Exclusion Criteria:

* \<18 years old
* A recent history (within the past 6 months) of ocular trauma, infection, or uveitis
* Baseline IOP \<21 mm Hg or \>35 mm Hg
* History of cardiovascular, pulmonary, cerebrovascular, or chronic renal disease
* History of borderline or uncontrolled systemic arterial hypertension
* Use of any systemic α-agonist or β-blocker within 30 days of study commencement
* History of receiving general anesthesia within the previous 30 days
* Pregnant women and nursing mothers
Effects of Menopause Hormonal Therapy and Selective Serotonin Reuptake Inhibitor on Cognition, Sexual Function and Quality of Life

Cross-sectional study with postmenopausal women using hormone therapy or serotonin reuptake inhibitor to relieve climacteric symptoms or without any treatment. Participants will answer three questionnaires: FSFI (the Female Sexual Function Index), MENQOL (Menopause-specific Quality of Life) and MEEM (Mini-Mental State Examination). The results will be compared according to treatment group.

Climacteric is a period marked by the reduction of estrogen levels, which leads to the occurrence of various symptoms that can affect a woman's physical, mental, sexual health and quality of life. The use of hormonal therapy (HT), with replacement of estrogen or estrogen and progestin, is indicated to alleviate these symptoms, aiming to improve the woman's quality of life. In addition, it is possible to use other forms of treatment to alleviate these symptoms, including selective serotonin reuptake inhibitors (SSRI), which play a major role in vasomotor symptoms. SSRIs have been used with moderate success in women who have contraindications to the use of HT or do not wish to use it. Objective: This study aims to analyze and compare the effects of HT and SSRIs in the treatment of climacteric symptoms in relation to cognitive and sexual function and quality of life in climacteric women. Methodology: This is a cross-sectional study to be carried out with menopausal women treated at the Centro de Atenção Integral à Saúde da Mulher (CAISM) in the city of São Bernardo do Campo/SP/Brazil. Participants who sign the Informed Consent Form will answer 3 questionnaires: FSFI (Female Sexual Function Index), WHOQOL-Bref (World Health Organization Quality of Life Instrument Bref) and MEEM (Mini-Mental State Examination). The results will be compared according to treatment group.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women aged between 45 and 65 years who are literate;
* Patients with at least 6 months of follow-up at the institution and who consented to participate in the research.

Exclusion Criteria:

* Women with psychiatric illness;
* Being on medication with action on the Central Nervous System due to psychiatric indication;
* Cognitive impairment that makes it impossible to understand the issues;
* Illiteracy;
* Absence of at least one sexual activity in the last 4 weeks.