cyrilzakka/clinical-trials huggingface dataset:
The THINK Study Incidence of Neurotrophic Keratopathy)

The study purpose is to evaluate corneal sensitivity in patients that have Stage 1 Neurotrphic Keratopathy (NK). Identifying patients with Stage 1 NK, may predict those who will in the future require rhNGF for optimal visual performance.

The purpose of this study is to evaluate corneal sensitivity in a cross-section of patients with signs of dry eye disease (DED), correlating findings against clinical parameters relating to the severity of disease and impact on quality of vision. Identifying those patients with Stage 1 Neurotrophic Keratopathy (NK), i.e. those with corneal staining and reduced sensitivity, may predict those who will in the future require rhNGF for optimal visual performance.

Eligibility Criteria:
Inclusion Criteria:

\*Patients with the following: A diagnosis of dry eye disease Central or inferior corneal fluorescein staining defined by the Oxford Scale Reduced tear break up time (TBUT) ≤ 10 seconds.

* Able to comprehend and sign a statement of informed consent.
* Willing and able to complete all required postoperative visits.

Exclusion Criteria:

* Ocular surgery (e.g., intraocular, oculoplastic, corneal, or refractive surgical procedure) performed within the last 3 months or at any time in the investigator's clinical judgment if it would interfere with the outcome measures of this study.
* Evidence of BAK or other chemical toxicity that, in the best judgment of the investigator, is causing reduced corneal sensitivity
* Concomitant use of daily contact lenses that, in the best judgment of the investigator, is causing reduced corneal sensitivity
* Clinically significant ocular trauma.
* Active ocular Herpes simplex or Herpes Zoster infection
* Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis) at the discretion of the investigator.
* Ocular infection (e.g., viral, bacterial, mycobacterial, protozoan, or fungal infection or the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye).
* Active, systemic, or local disease condition that causes clinically significant ocular surface irritation such that it could interfere with the study findings.
* Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis.
* Severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis)
* Eyelid abnormalities that significantly affect the lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis).
* Ocular surface abnormality that may compromise the corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, map dot fingerprint dystrophy, or the effect of any other ophthalmic medication that might in the opinion of the investigator compromise the ocular surface integrity).
* Participation in this trial in the same patient's fellow eye
* Patients who are under age 18, pregnant or breastfeeding, or who may become pregnant during participation in the study.
A New Medicine to Treat Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

Determine whether dalfampridine (Ampyra) can improve visual function in patients who have had nonarteritic ischemic optic neuropathy (NAION) with stable visual impairment.

The aim of this study is to determine whether dalfampridine can improve visual function in patients who have had nonarteritic ischemic optic neuropathy (NAION) with stable visual impairment.

The objective of this double masked crossover study is to determine whether visual function can be improved in numerous parameters. This includes high contrast visual acuity, low contrast visual acuity, visual field, visual quality of life (VFQ-39), electrophysiology, multi focal electro retinography (mERG), visual evoked potential (VEP), and structure, spectral domain optical coherence tomography (OCT).

Based on the promising results of the use of dalfampridine in Multiple Sclerosis (MS) and in stroke, we hypothesize that the patients with chronic stable deficits after nonarteritic ischemic optic neuropathy (NAION) will have improved visual function with the administration of dalfampridine.

Eligibility Criteria:
Inclusion Criteria:

* NAION 6 months prior to enrollment
* visual acuity of 20/40 or worse

Exclusion Criteria:

Current use of Dalfampridine (Ampyra)

* Pregnancy
* History of seizures
* Renal Failure
* Not able to perform testing
UAS-RBS: a Safety Study

A novel stent, called Universal Partially Covered Removable Self-expanding Stent and Anchoring System for the Treatment of Refractory Benign Esophageal Strictures (UAS-RBS) was designed to improve the treatment of benign esophageal refractory strictures with a novel stent. This study aims at evaluating the safety of this new device.

Refractory strictures are defined as benign esophageal strictures who do not achieve acceptable symptom relief despite an intensive dilation schedule. Considering the failure of balloon or mechanical dilation other techniques such as intralesional injection of corticosteroids or stents placement were developed.

Self-expandable metal stents, plastic stents and biodegradable stents are also used in that indication. In a meta-analysis of 18 studies with 444 patients, clinical success was achieved in 41 percent of patients. Stent migration occurred in 29 percent of patients, and adverse events occurred in 21 percent.

A self-expending nitinol stent has been design to reduce the migration risk. The stent is partially covered on both extremities, allowing the formation of small hyperplasia in the middle part of the stent. This design with the inner sheet (usually, when using fully covered stents, the sheet is outside) allows formation of hyperplasia (therefore reducing the risk of migration) but partly controlled by the inner sheet to reduce the risk of lumen occlusion. By this design, the balance between hyperplasia formation to avoid the risk of migration and reducing the risk of lumen occlusion could be entailed stable esophageal calibration.

The UAS-RBS system is a reversible procedure to treat Refractory Benign Esophageal Strictures through stent implantation. Above standard of care monitoring, safety assessment of the procedure and device performance decreases the risk and unforeseen events.

Eligibility Criteria:
Inclusion Criteria:

* Benign Esophageal Refractory Stricture no more than 40 mm in length.
* More than two dilations to at least 16 mm in diameter with symptoms relapse within 6 months.
* Last dilation to 16 mm no more than 6 months before study procedure.
* Dysphagia score of 2 (ability to swallow semi-solid foods), 3 (ability to swallow liquids only) or 4 (unable to swallow liquids) at the time of measurement.
* Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

* Stricture within 2 cm of the upper esophageal sphincter.
* Dysphagia related to motility disorder.
* Planned adjuvant radiation therapy post esophagectomy.
* Esophageal stent in place.
* Active erosive esophagitis.
* Sensitivity to any components of the stent or delivery system.
* Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety.
* Currently enrolled in another clinical trial.
An Intervention to Improve Communication Between Physicians and Minority Patients With Hypertension

The objective of the project is a test-of-concept of an intervention to reduce the effects of the perception of discrimination on the care of patients with chronic illness. Perception of discrimination manifests itself as stereotype threat. We hypothesize that stereotype threat impairs communication between minority patients and their physicians because of increased stress and diminished trust, resulting in interactions that are less successful at enhancing patient self-efficacy, in turn resulting in lower rates of adherence with anti-hypertensive medication.

The intervention is a self-affirmation exercise performed prior to a patient-physician visit. A similar intervention has been shown to reduce the racial gap in academic performance in middle school classrooms.

We will explore the mechanistic effects of the intervention by analysis of audiotapes of patient-provider visits following the intervention. We will measure the effect of the intervention on minority hypertensive patients' adherence with antihypertensive medication and blood pressure.

We will enroll 200 African American and Latino patients with hypertension and randomize 100 patients to perform the exercise and 100 patients to perform a null control exercise before the visit. We will assess change in patient's adherence with antihypertensive medications and in blood pressure over the six months following the index visit. In order to better understand the effects of the intervention we will measure subject's mood following the exercise, and self-reported stress levels, trust in the physician, and medication self-efficacy following the visit. We will also assess the quality of the patient-provider interaction from detailed analysis of audiotapes and from patient questionnaires. Following a subsequent patient-physician visit, we will conduct telephone interviews with patients to assess for persistence of any effects of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of hypertension
* age \> 21 years
* use of Denver Health as their usual source of care and pharmacy services
* self-described race/ethnicity of African American or Latino
* ability to provide informed consent

Exclusion Criteria:

* pregnancy-related hypertension
* end-stage renal disease
* unable to speak or write English at at least a 6th grade level.
The Accuracy of Tests of Eustachian Tube Function

The Eustachian tube links the middle ear to the back of the nose and is designed to open to allow the pressure in the air-filled middle ear to be equal to external (atmospheric) pressure. In some people this system fails to work properly leading to abnormal pressure in the middle ear, and complications such as middle ear fluid ('glue ear') or damage to the ear drum. The abnormal function of the Eustachian tube is called 'Eustachian tube dysfunction'. An affected person may feel pressure, pain or other symptoms in their ear, and their hearing can be temporarily or permanently reduced.

This study is designed to find out which of a number of simple tests is best at detecting if the Eustachian tube is performing normally. Both patient-completed questionnaires and clinical tests using specialist machines will be compared as a way of diagnosing Eustachian tube dysfunction.

A group of adults aged 18 and above, and children aged 5-17 years with normal ears, and a similar group of people that are already known to have Eustachian tube dysfunction, will both take six different tests and complete four different questionnaires. The differences in the results between the group with ETD and the healthy group will be compared. The results for each test or questionnaire will be compared to see which is best at telling the healthy and Eustachian tube function groups apart, and therefore at diagnosing Eustachian tube dysfunction. The investigators will also look to see if a combination of one or more of the tests or questionnaires is best at diagnosing the disease.

The results of this study hope to provide a test or combination of tests that can be used on a daily basis by ENT doctors. The assessment technique would also be helpful in researching and comparing new treatments for ETD.


Eligibility Criteria:
Duloxetine Compared With Placebo in Patients With Generalized Anxiety Disorder

This is a clinical trial assessing duloxetine compared with placebo in patients who have generalized anxiety disorder.


Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients at least 18 years of age

Exclusion Criteria:

* Have previously completed or withdrawn from this study or any other study investigating duloxetine or have previously been treated with duloxetine
* Patient diagnosed with major depressive disorder within the past 6 months
* Patient diagnosed with panic disorder, post-traumatic stress disorder, or an eating disorder within the past year
* History of alcohol or any psychoactive substance abuse or dependence within the past 6 months
Predictive Value of Analysing Tissue From Patients With Metastatic Pancreatic Cancer for Drug Sensitivity

It will be investigated whether it is possible to predict the effect or lack of effect of first-line treatment by analysing cancer cells from the individual patient receiving standard first line treatment. Also, the feasibility of selecting second-line therapy based on pre-treatment biopsies will be investigated.

Cells from pancreatic cancer will be grown in the laboratory to form small, circulating tumors and adjacent tissue, so called tumoroids. The tumoroids will then be exposed to different pre-specified anticancer drugs to hopefully reveal sensitivity or lack of sensitivity in the specific patient.


Eligibility Criteria:
Inclusion Criteria:

* Non-resectable pancreatic cancer

  * Biopsy proven adenocarcinoma compatible with pancreatic origin (primary tumor or metastasis)
  * If only biopsy from metastasis can be obtained, the patient must have a previously resected or image proven tumor of the pancreas
  * Deemed non-resectable at a multidisciplinary conference
* Candidate to standard systemic therapy, defined as one of

  * Gemcitabine monotherapy,
  * Gemcitabine and nab-paclitaxel combination,
  * Gemcitabine and capecitabine combination,
  * 5-fluorouracil, oxaliplatin and irinotecan combination (FOLFIRINOX), or
  * New standard treatments approved by the multidisciplinary cancer group 'Danish Pancreatic Cancer Group' in the inclusion period.
* Measurable disease according to RECIST 1.1
* ECOG performance status 0-2
* Age at least 18 years
* Adequate bone marrow, liver and renal function allowing systemic chemotherapy

  * Absolute neutrophil count ≥1.5x10\^9/l and thrombocytes ≥ 100x10\^9/l
  * Bilirubin ≤ 3 x upper normal value and alanine aminotransferase ≤ 5 x upper normal value
  * Calculated or measured renal glomerular filtration rate at least 30 mL/min
* Contraception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject's male partner or hormonal contraceptive are acceptable
* Written and orally informed consent

Exclusion Criteria:

* Potentially resectable disease

  * Incapacity, frailty, disability, or comorbidity to a degree that according to the investigator is not compatible with participation in the protocol
  * Other active malignant disease requiring therapy
  * Other systemic anti-cancer therapy (palliative radiotherapy is allowed)
  * Pregnant (positive pregnancy test) or breast feeding women
Descartes-11 Consolidation Treatment in Patients With High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy

To assess Minimal Residual Disease (MRD)-negative Complete Response (sCR) rate after consolidation treatment with Descartes-11 in patients with high-risk myeloma who have residual disease following induction therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18 years of age or older at the time of enrollment
* High-risk multiple myeloma patients who complete pre-transplant induction treatment anti- myeloma drug combination (minimum 2 drugs).

Exclusion Criteria:

* Patients who are pregnant or lactating.
* Patients who have any active and uncontrolled infection. No blood cultures are necessary unless clinically indicated.
R115777 in Treating Patients With Advanced Bladder Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have advanced bladder cancer.

OBJECTIVES: I. Determine the efficacy of R115777 in terms of objective response in patients with advanced transitional cell cancer of the urothelial tract. II. Determine the safety of this treatment regimen in these patients. III. Determine the time to disease progression in these patients with this treatment regimen.

OUTLINE: This is a multicenter study. Patients receive oral R115777 every 12 hours for 21 days in the absence of disease progression or unacceptable toxicity. Treatment repeats every 28 days for at least 2 courses. Patients are followed every 3 months for up to 5 years.

PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed transitional cell carcinoma of the urothelial tract not curable by surgery or radiotherapy Bladder, renal pelvis, or ureter Stage II, III, or IV (T2-4, N0-3, M0-1) with unresectable disease Poorly differentiated transitional cell carcinoma or predominant transitional cell carcinoma with foci of squamous differentiation or rare foci of adenocarcinoma allowed No adenocarcinoma, small cell carcinoma, sarcoma, or squamous cell carcinoma Bidimensionally measurable disease No disease confined to the bladder only No soft tissue disease irradiated within the past 2 months No known active CNS disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: SGOT no greater than 2 times upper limit of normal (ULN) Bilirubin normal Renal: Creatinine no greater than 2 times ULN Other: No unresolved, active bacterial infection requiring antibiotics No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent myeloid colony stimulating factors Chemotherapy: At least 12 months since prior adjuvant or neoadjuvant chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered Surgery: At least 4 weeks since prior surgery and recovered Other: No prior systemic therapy (including investigational agents) for metastatic bladder cancer At least 4 weeks since prior intravesical therapy and recovered At least 30 days since prior participation in other investigational drug trial No concurrent intravesical therapy No other concurrent therapy for cancer
Analgesic Effect of M-TAPA on LC

Objective: To investigate the postoperative analgesic efficacy of M-TAPA block and its effect on opioid consumption in patients undergoing laparoscopic cholecystectomy (LC) surgery.

Place and Duration of Study: Department of Anesthesiology and Reanimaton, Sivas Cumhuriyet University, Sivas, Turkey, from April 2023 to May 2023.

Methodology: There were two randomized groups: Group M-TAPA (n=21) and Group Control (no block) (n=21). All patients had standard general anesthesia. Group M-TAPA patients had bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery. Group Control had only tramadol for posteperative pain. Numerical rating scale (NRS) and visual analogue scale (VAS) were used to assess postoperative pain. Total tramadol consumption was calculated.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients older than 18 years of age who underwent elective laparoscopic cholecystectomy under general anesthesia and were American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.

Exclusion Criteria:

* Patients who did not give consent,
* patients with coagulopathy,
* patients with signs of infection at the block application site,
* patients using anticoagulants,
* patients with local anesthetic drug allergies,
* patients undergoing open surgery,
* patients with unstable hemodynamics,
* patients who could not cooperate during postoperative pain assessment
Semaglutide Anti-Atherosclerotic Mechanisms of Action Study in Type 2 Diabetes Patients

Diabetes is a chronic disease characterized by chronic hyperglycaemia, causing microvascular and macrovascular complications. The latter lead to various disabilities: blindness, end-stage renal failure, nerve damage, formation of leg ulcers, and atherosclerosis. In people with type 2 diabetes, the probability of these atherosclerosis associated complications is twice as high as in people without diabetes. Cardiovascular diseases are also the main cause of mortality in people with diabetes.

Preventive measures are therefore crucial. In people with type 2 diabetes, in addition to good glycaemic control, the choice of antidiabetic drugs is also important. Large-scale research has shown that certain glucagon-like peptide (GLP-1) receptor agonists, in addition to improving the regulation of diabetes, also have a significant effect on reducing the macrovascular complications. It is now possible to use semaglutide, a GLP-1 receptor agonist, in the tablet form. Semaglutide lowers blood sugar only when the blood sugar value rises, due to food in the digestive tract, Thus, not increasing the risk of hypoglycaemia. In addition, semaglutide has a significant effect on weight loss and very beneficial, protective effects on the cardiovascular system. Large studies have shown that in its injectable form, it significantly reduces the incidence of cardiovascular death in patients with type 2 diabetes.

Therefore, the aim of the present study is to examine how semaglutide provides protective effects on the cardiovascular system and reduces the risk of diabetes type 2 associated complications.

The present study will include 100 people with type 2 diabetes and last for 12 months. The subjects will receive a semaglutide oral tablet daily in addition to their current treatment (combination of metformin and a sulphonyl urea). At the beginning of the study, after 6 months and at the end of the study (after 12 months of treatment), a detailed clinical examination will be performed and blood will be taken for laboratory parameters. In addition to basic blood tests, inflammatory and oxidative stress parameters, as well as lipid fractions parameters will also be assessed. Ultrasound examination of the changes in the carotid arteries and measures of additional properties of the arteries will also be performed. The confidentiality of the data of the participants in the research will be ensured, as the data obtained during the investigation will be encrypted before processing.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* therapy including at least metformin 1000 mg and sulphonyl urea at least half of the maximal dose
* BMI \> or = 30 kg/m2
* HbA1c \< or = 8,5%
* associated risk factors including smoking, dyslipidaemia, arterial hypertension, chronic kidney disease stage 1 to 3.

Exclusion Criteria:

* therapy with injectable GLP-1 receptor agonist ongoing or was taking place in the last year
* manifested cardiovascular disease
* heart failure
* chronic kidney disease stages 4 and 5
* advanced liver disease
* proliferative retinopathy or maculopathy