cyrilzakka/clinical-trials huggingface dataset:
Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications

To evaluate glaucoma patients' response to treatment with Xiidra, an FDA-approved drug for ocular surface discomfort, which will be prescribed as standard of care treatment.

To assess glaucoma patients' response to treatment with Xiidra (Lifitegrast ophthalmic solution) 5% for ocular surface discomfort caused, in part, by topical glaucoma antihypertensive medications.

Eligibility Criteria:
Inclusion Criteria:

* Currently using one or more topical glaucoma antihypertensives
* Self-described symptoms of ocular surface discomfort
* Xiidra is being prescribed as part of the subject's standard care

Exclusion Criteria:

* History of glaucoma filtration surgery, history of ocular surface surgery (pterygium, conjunctivoplasty, etc.),
* current use of topical cyclosporine
* current use of topical steroids
* incisional ocular surgery within 6 months
Prevalence of Wild Type ATTR

Prospective, observational, single-centre, non-interventional study aiming at reporting the prevalence of ATTRwt in patients with lumbar spinal stenosis (LSS).

The study will include patients that receive surgical management and treatment for LSS, and will consist in the prospective, longitudinal collection of peripheral blood, urine samples, tissue biopsies and clinical data. The results of the project could provide a future benefit for patients with the same condition by: i) identifying accessible and sensitive biomarkers for the identification of patients at risk for having an underlying ATTRwt; ii) optimizing the therapeutic strategies in an era of innovative but cost-intensive treatments; iii) provide the proof of principle for a regular follow-up of patients who eventually will become symptomatic for overt organ ATTRwt involvement; and iv) providing the rationale for future studies based on early access disease-modifying approaches.

Eligibility Criteria:
Inclusion Criteria:

* Male and female ≥ 50 years-old with indication of surgery treatment according to local standards for Lumbar spinal stenosis (LSS) confirmed by MRI
* Availability of the baseline and follow-up annotations
* Informed consent will be obtained from the patient before any study related procedures

Exclusion Criteria:

* Previous diagnosis of amyloidosis
Retrograde Intrarenal Surgery (RIRS) With Suction

Suction has been initially used in endoscopic stone management for more than 25 years during PCNL, but the emergence of new devices applying suction through patented ureteroscopes, ureteral access sheaths (UAS) and ureteral catheters led to application of suction in URS/RIRS. The application of ureteral access sheath (UAS) in RIRS can improve surgical vision , reduce intrarenal pressure (IRP) ,and decrease postoperative infectious complications .


Eligibility Criteria:
Inclusion Criteria:

* Single stone
* Medium sized stone ≤ 3 cm
* Renal stone
* age group \> 18

Exclusion Criteria:

* multiple renal stones
* stone size \> 3 cm
* age group \< 18
* solitary kidney
* Obstruction distal to the stone.
* urinary tract infection
Transportation Safety in Adolescence

The proposed project will focus on improving teen driver safety as motor vehicle crashes are the leading cause of death and injury to adolescents. If successful, research findings will lead to clear strategies to reduce motor vehicle crashes.


Eligibility Criteria:
Inclusion Criteria:

* Teens between 16 and 17 years and 4 months (17.33 years) of age
* Pennsylvania state learner's permits
* Will have their Pennsylvania state learner's permit for at least 6 months (self-report)
* Self-report of less than 10 hours of behind-the-wheel driving experience.
* Teen and parent/caregiver fluent in written and spoken English
* Access to at least one practice vehicle
* Email address and internet access to complete study procedures

Exclusion Criteria:

* Teens with self-reported or parent reported (of teen's) visual, medical, or physical impairments that would require a handicap placard or assistive device to drive.
* Teens with pervasive developmental delays
* Have a sibling enrolled in this study
* Enrolled in other teen driving studies
Preference Study Between NovoFine® Autocover™ and a NovoFine® 8 mm Needle

This trial is conducted in Europe. The aim of this clinical trial is to assess the preference of 2 different needles used by nurses and health assistants. The trial consists of a handling test followed by a 12 week cross-over study.


Eligibility Criteria:
Inclusion Criteria:

* The participant must have been either a diabetes nurse or a diabetes health assistant with competence in subcutaneous injections of insulin for at least 4 weeks
* Participants must demonstrate proficiency with the injection device in the handling test prior to testing the NovoFine® Autocover™ Needle in patients
Dysplasia in Inflammatory Chronic Idiopathic Colitis Long-standing

Chronic intestinal inflammation produce dysplasia more frequently than the normal population. The therapies protect against these changes, but do not rule out dysplasia. It is not known the effect of different therapies protection.

The literature data show that the inflammatory bowel diseases (rectal ulcerative colitis and Crohn's disease) determine an increased risk of developing dysplasia and cancer of the colon and rectum, for the chronic inflammation that they fee, with the differences that the two diseases arise. The progression from normal mucosa to dysplasia and then to cancer is more rapid than in the adenoma-carcinoma sequence.

In patients with idiopathic chronic inflammatory colitis drug therapies in use reduce the incidence of dysplasia.

A systematic review concluded in favor of a chemo preventive effect of mesalazine. In any case, it has been reported protective association between use of mesalazine and cancer associated with colitis (colitis Associated carcinoma CAC) with an odds ratio of 0.51 per CAC / dysplasia. This data, in subsequent studies, including recent ones, have remained controversial.

The introduction of biological drugs in the treatment of patients with inflammatory bowel disease (IBD) has changed the quality of life and also the natural history of the disease. It is not known what biological drugs have improved the clinical history of these diseases by changing the incidence of dysplasia and colorectal cancer.

The treatment of idiopathic inflammatory bowel diseases (IBD), the last decade has seen profound changes and, now, the use of biological drugs is frequent in the moderate-severe forms, especially if extended. Mesalazine has in the indication of mild to moderate forms of therapy.

Eligibility Criteria:
Inclusion Criteria:

* long standing colonic inflammatory bowel disease
* clinical, endoscopic and histological remission
* completeness of data

Exclusion Criteria:

* important comorbidities
* family history of colorectal cancer
* insufficient data
Urban Environmental Exposures and Childhood Cancer

The Environmental Protection Agency has recognized that organophosphorus pesticides require close regulation and continued monitoring for human health effects and some (e.g chlorpyrifos) have been phased-out from the consumer market due to the special risk that it posed for children. There is growing evidence in support of the association between pesticide exposure and childhood leukemia. Studies of pesticides and their association with childhood cancer have been limited by study designs, self-reporting and lack of biological measurements. While several large studies in California found little evidence of an association between agricultural pesticide use and childhood leukemia, these results are in contrast with the associations observed with household exposures to pesticides. The real association may depend on timing of exposure, type of pesticide, dose and pathway of exposure. Furthermore, some persons may be more susceptible to the effects of specific pesticides due to inherited mutations in their detoxification pathways.

We are conducting a pilot study to test the hypothesis that environmental exposure to pesticides in pregnancy or during the neonatal period, together with genetic susceptibility may lead to childhood ALL or brain cancer. The study is a multicenter, case-control study, based on collaboration between clinical researchers and basic science research to evaluate the risk for childhood cancer in relation to measured levels of pesticides (and their metabolites) and genetic polymorphisms. Biomarkers will be used to examine the risks of chronic low-dose exposures, and to characterize relationships between specific pesticides, childhood cancer and genetic susceptibility.

Hypothesis: Interaction between environmental factors (pesticides) and maternal or child genetic polymorphisms may lead to childhood cancer.


Eligibility Criteria:
Inclusion Criteria:

* Only newly diagnosed cases of ALL and brain cancers (i.e. diagnosed within the previous 12 months) under the age of 18 years are eligible for this study. These will include live born infants at term or born prematurely, and any cases we are able to ascertain from pediatric hematology records.
* Healthy controls of similar age will be recruited.
* The children must have a parent available to be interviewed who speaks English or Spanish well enough to understand the questionnaire.

Exclusion criteria:

* Subjects with a diagnosis of Down syndrome or other chromosomal disorder, single gene disorder, or recognized multi-organ syndrome will be excluded.
* Non-residents of Maryland, the District of Columbia, and Virginia will be excluded; this will avoid the inclusion of out-of-state case families who traveled a long distance for clinical care, where control sampling would be problematic.
FAPI PET/CT Prospective Interobserver Agreement

The aim of the present study is to evaluate the interobserver agreement for FAPI PET/CT interpretations of representative cancer types and compare findings among readers with different levels of experience.

Fibroblast activation protein (FAP) is expressed by many cancer-associated fibroblasts, having a pivotal role in many desmoplastic tumor histotypes (sarcoma, pancreatic cancer, colorectal cancer). 68Ga-FAPI inhibitor (FAPI) is a promising novel molecular imaging tracer for positron emission tomography with computed tomography (PET/CT), with favorable initial results in different tumor entities. Compared to 18F-FDG, 68Ga-FAPI PET/CT shows a similar biodistribution, with less background tracer uptake in the brain, oral mucosa and liver, thus making this tracer potentially suitable to detect tumor lesions in these regions.

Moreover, the FAPI ligand contains a DOTA peptide which makes it appropriate also for therapeutic options if linked with 177Lutetium or 90Yttrium.

There is an increasing number of trials aimed to assess the efficacy and the clinical impact of 68Ga-FAPI PET/CT. Therefore, the inter-observer agreement and variability with 68Ga-FAPI PET/CT need to be established.

Eligibility Criteria:
Inclusion criteria:

Nuclear medicine physicians or radiologists with a prior experience with 68Ga-FAPI PET/CT from high-volume centers (Essen, Germany; Bologna, Italy; Los Angeles, USA; Munich, Germany, Münster, Germany ) will be prospectively recruited as research observers. Each observer will be asked to report the number of previous clinical 68Ga-FAPI PET/CT scans and then will be classified on the basis of the experience in these three groups:

* Low experience (\< 30 prior 68Ga-FAPI PET/CT studies);
* Intermediate experience (30 to 300 studies);
* High experience (\> 300 studies) At least three observers will be needed for each group.

Exclusion criteria:

No prior PET/CT experience.
Study Evaluating Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy.

SP746 (NCT00546351) is a multi-center, open-label, follow-on trial. The purpose of this trial is to assess safety and tolerability of long-term exposure of lacosamide (previously referred to as SPM 927) in subjects with painful distal diabetic neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who completed Study SP743 (NCT00238524) or SP874 (NCT00350103) and, in the investigator's opinion, might benefit from long-term administration of SP746 (NCT00546351). Exception: subjects who prematurely discontinued
* SP743 (NCT00238524) or SP874 (NCT00350103) due to lack of efficacy or due to intolerability to trial medication (after Visit 5but prior to entering the Maintenance Phase) may be eligible to participate in SP746 (NCT00546351), after consultation with the medical monitor

Exclusion Criteria:

* Subject has clinically relevant ECG abnormalities, or a QTc interval ≥500 ms, and/or a QTc interval increase of ≥60 ms from the mean pre-dose QTc value at Visit 2 of SP743 (NCT00238524) or SP874 (NCT00350103)
* Subject has aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≥3 times the upper limit of the normal range (ULN) with total bilirubin ≥2 times ULN or transaminases (AST and/or ALT) ≥5 times ULN
* Subject has a clinically relevant medical condition that, in the opinion of the investigator, jeopardizes or compromises the subject's ability to participate in this trial
* Subject is a pregnant or nursing female, or is of childbearing potential and is not surgically sterile, 2 years postmenopausal, or does not practice 2 combined methods of contraception
Inpatient COVID-19 Lollipop Study

This study is being done to see if collecting saliva samples with a "lollipop" collection method works as well as nasopharyngeal samples for COVID-19 polymerase chain reaction (PCR) testing. 225 COVID-positive participants aged 4 years and above admitted to a hospital in the Madison, Wisconsin metropolitan area will be enrolled over a 6 month period.

This is a prospective quantitative study evaluating the utility of a novel method of saliva collection for COVID-19 testing.

Primary Objective

* To determine the performance characteristics of oral lollipop swabs compared to Nasal Pharyngeal (NP) swabs for diagnosing COVID-19 via PCR molecular testing.

Secondary Objectives

* To identify clinical characteristics of patients when there are discordant results for NP and oral lollipop test results.

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and the willingness to provide verbal informed consent, if 18 years or older. If 4-17 years old, ability to understand and the willingness to provide verbal assent, plus have a parent or legal guardian present who can provide verbal informed consent.
* Willing to comply with all study procedures and be available for the duration of the study.
* Admitted to UW Health University Hospital or UW Health Kids American Family Children's Hospital.
* Individuals at least 4 years of age.
* Verified COVID-19 according to positive NP PCR test criteria.
* Enroll within 47 hours of the diagnostic NP swab; lollipop swab collected within 48 hours of the diagnostic NP swab.
* Either personally able or have a parent or legal guardian able to verbally answer questions in English about clinical symptoms, exposures, and other health and demographic information.

Exclusion Criteria:

* Unable to suck on a swab.
* Previous participation in this study.
* Require translation services for medical care.
* Not suitable for study participation due to other reasons at the discretion of the investigators or their designee.
Transfer Modality Research Initiative - Bangladesh

This is a randomized control trial in two zones of Bangladesh (north and south). Treatment is assigned at the village level where treatments are: cash transfers (north and south); cash transfers + nutrition behavior communication change (north only); food transfers (north and south); food transfers + nutrition behavior communication change (south only); food-cash split (north and south); and controls (north and south). Within treatment localities, women living in very poor households are targeted to receive benefits for two years.


Eligibility Criteria:
Inclusion Criteria:

* Child age \< 60 months

Exclusion Criteria:

* None
Protein Supplementation and Skeletal Muscle Healing Process

In this study the investigators utilized protein supplementation over an 8-day period following eccentric exercise-induced muscle damage in order to test the initial hypotheses : i) protein supplementation after exercise-induced muscle injury affects exercise-induced aseptic inflammation and muscle performance.

The objective was to examine weather protein supplementation is able to affect the inflammatory response as well as recovery of muscle performance following an intense eccentric exercise protocol. In a double-blind, counterbalanced design, 14 men received either Placebo (PLA) or milk protein isolate (PRO) for 8 consecutive days following a single bout of exercise (300 eccentric contractions at 30 deg/sec). In both conditions, performance was assessed at baseline, immediately post-exercise, 2h post-exercise and daily for 8 consecutive days. Blood samples were collected at baseline, 2h post-exercise and daily for the remaining 8 days. Muscle biopsies from vastus lateralis were collected at baseline as well as at day 2 and day 8 of the post-exercise period.

Eligibility Criteria:
Inclusion Criteria:

* a) recreationally trained as indicated by the maximal oxygen consumption levels (VO2max \> 45 ml/kg/min), b) engaged in systematic exercise at least three times per week for \> 12 months, c) non-smokers, d) abstained from any vigorous physical activity during the study, e) abstained from consumption of caffeine, alcohol, performance-enhancing or antioxidant supplements, and medications during the study.

Exclusion Criteria:

* a) a recent febrile illness, b) history of muscle lesion, c) lower limb trauma
Safety and Efficacy of Bleach Baths in Non Critical Hospitalized Patients

Non critical hospitalized patients were bathed daily with 4 substances: bleach at .005%, bleach at .0125%, clorhexidine 2% and soap and water.

76 patients were enrolled and divided 19 subjects per group. Each patient was cultured with swab technique in palm, antecubital fold and armpit at day 0, day 3 and day 7 of enrollment.

Bacterial cultures were incubated and compared if decolonization occurred. Adverse events were evaluated in all patients.

Only 1 patient had and adverse event and was dry skin. Before patient was enrolled, he had dry skin because of his baseline disease. Moisturizing lotion was applied and patient continue in the study.


Eligibility Criteria:
Inclusion Criteria:

* Non critical hospitalized patients in internal medicine
* 18 years old and older

Exclusion Criteria:

* Burn patients
* Pregnant women
* Chloride hypersensitivity
MK0431 (Sitagliptin) and Metformin Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-036)

The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus (T2DM) (a specific type of diabetes).


Eligibility Criteria:
Inclusion Criteria:

54-Week Base Study:

* Patients between the ages of 18 and 78 with Type 2 Diabetes Mellitus (a specific type of diabetes)

  50-Week Extension Study:
* Patients who complete the 54-week base study are eligible to enter the 50-week extension study

Exclusion Criteria:

* Patients who do not have Type 2 Diabetes Mellitus (a specific type of diabetes)
A Study to Assess the Safety, Tolerability, Effectiveness and Absorption of Exodif™ Tablets in Clostridium Difficile-associated Diarrhea

Approximately 65 patients will be entered into this study taking place in North America. The aim of this study is to evaluate the safety, efficacy and absorption of an investigational drug in patients with C. difficile-associated diarrhea (CDAD). All study related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* The presence of CDAD at the time of enrollment
* Negative serum pregnancy test (HCG) for women of childbearing potential.

Exclusion Criteria:

* Any contraindication to oral / enteral therapy including fulminant C. difficile disease.
* Any acutely life-threatening medical conditions.
* Acute or chronic diarrhea of other cause.
A Study of LY03003 in Patients With Early-stage Parkinson's Disease

This study is to characterize the pharmacokinetics and to evaluate the safety as well as tolerability of LY03003 following multiple escalating intramuscular injections


Eligibility Criteria:
Inclusion Criteria:

* Patient had Parkinson's Disease that meet the clinical diagnostic criteria of the brain bank of the Parkinson's Disease Association of the United Kingdom.
* Patient was Hoehn \& Yahr stage ≤3 (excluding stage 0) ;
* Patient was male or female aged 18 to 75 years;
* Patient had a Mini Mental State Examination (MMSE) score of ≥25;
* Patient had a Unified Parkinson's Disease Rating Scale (UPDRS) motor score (Part III) of ≤30 at Screening.
* Patient who signed the informed consent form volunteered to participate in this clinical trial and could cooperate with the prescribed inspections.

Exclusion Criteria:

* Patient had a history of pallidotomy, thalamotomy, deep brain stimulation, or fetal tissue transplant;
* Patient had dementia, schizophrenia or hallucinations, or clinically significant depression;
* Patient had a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or presence of suicidal tendency in the past year;
* Patient had a history of orthostatic hypotension.
* Patient had received therapy with a dopamine (DA) agonist either concurrently or had done so within 28 days prior to the Screening;
* Patient had received therapy with 1 of the following drugs either concurrently or within 28 days prior to Screening: monoamine oxidase B (MAO-B) inhibitors (e.g., pargyline, selegiline), DA releasing agents (e.g., amphetamine), reserpine, DA-antagonists (e.g., metoclopramide), neuroleptics, or other medications that may interact with DA function;
* Patient was currently (at the time of Screening) receiving central nervous system active therapy (e.g., sedatives, hypnotics, antidepressants, anxiolytics), unless the dose had been stable for at least 28 days prior to Screening Visit and was likely to remain stable for the duration of the study;
* Patient had a current diagnosis of epilepsy, had a history of seizures as an adult within 1 year prior to Screening, had a history of stroke or transient ischemic attack within 3 months prior to Screening;
* Patient had a history of known intolerance/hypersensitivity to non-dopaminergic antiemetics, such as domperidone, ondansetron, tropisetron;
* Patient had any other clinically relevant hepatic, renal, and cardiac dysfunction, or laboratory abnormality, which would have, in the judgment of the Investigator, interfered with the patient's ability to participate in the study;
* Patient had a history of allergic to any medication;
* Heavy smoker, alcoholic, drug addict;
* Female patients who were pregnant or were breastfeeding or were of childbearing potential without adequate contraception;
* Patient who was inappropriate to participant in the study in the judgment of the Investigator.