cyrilzakka/clinical-trials huggingface dataset:
Safety and Effectiveness of Minimally Invasive Micro Sclerostomy (MIMS®) to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy

The goal of this clinical trial is to show non-inferiority of the MIMS® device/procedure with Mitomycin-C, in terms of its surgical success rate, compared to trabeculectomy with Mitomycin-C in subjects diagnosed with primary open angle glaucoma, whose intraocular pressure is not controlled despite polypharmacy.

Eligible screened participants will undergo the MIMS® procedure and will be followed for a period of 12 months in this single-arm study. Investigators will compare the results of this study to the surgical success rate of traditional trabeculectomy with Mitomycin-C.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, ≥ 40 years to ≤ 85 years old
2. Inadequately controlled primary open angle glaucoma with screening mean diurnal IOP of ≥ 21 mmHg and ≤ 40 mmHg despite polypharmacy
3. Primary open angle glaucoma diagnosis based on:

   1. Visual field mean deviation of -3dB or worse and
   2. Glaucomatous optic nerve damage as evidenced by optic disc or retinal nerve fiber layer structural abnormalities documented on slit lamp stereo biomicroscopy or in stereo disc photos
4. Presence of healthy, free, and mobile conjunctiva in the target quadrant
5. Prior ab interno conjunctival-sparing glaucoma procedures were conducted more than 6 months prior to enrollment (e.g., iStent, Trabectome, gonioscopy-assisted transluminal trabeculectomy \[GATT\])
6. Subject is able and willing to attend all scheduled follow-up exams
7. Subject understands and signs the informed consent
Genetic, Microenvironmental, and Immunological Factors in Unresectable Pancreatic Ductal Adenocarcinoma

Pancreatic ductal adenocarcinoma (PDAC) complexity, where genetic, stromal, and immunological factors all interact with each other, is responsible for the overall poor response of PDAC to chemotherapeutic agents, making this a lethal disease. The investigators hypothesize that: (i) dissection of genetic, stromal, and immunological factors on endoscopic ultrasound fine needle biopsy (EUS-FNB) tissue samples from unresectable PDAC patients' will allow to determine prognostic factors in this patient population; (ii) treatment response and acquisition of tumor chemotherapy resistance could be related to genetic heterogeneity between the primary and metastatic sites and alteration of the molecular profile under drug' selection pressure.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred to EUS with FNB for suspected pancreatic cancer unresectable or metastatic based on imaging findings
* Availability of biopsies obtained during EUS-FNB
* Histological diagnosis of pancreatic ductal adenocarcinoma of any stage
* Patients must be fit for chemotherapy administration
* They have to express their willingness to be followed up at our pancreatic high volume centers
* Age \>18 and \<80 years
* Able to sign informed consent

Exclusion Criteria:

* Histological diagnoses other than pancreatic ductal adenocarcinoma
* Pregnancy or lactation
Identification of Y Chromosome From Free Circulating DNA in Patients With Turner Syndrome

Turner syndrome affects 1/2500 female newborns. It is characterized by a short stature, gonadal dysgenesis and bone anomalies. It is secondary to X chromosome abnormality. The clinical course can be marked by various complications, including degeneration of gonadal streaks into cancer (gonadoblastoma). The risk of gonadoblastoma is increased by the presence of Y chromosome, with a risk of 19 to 43%. However, Y chromosome material may be difficult to identify due to its mosaic state, at varying rates depending on the tissue. Free circulating DNA (cfDNA) corresponds to fragments of extracellular DNA present in the plasma, released into the circulation during cell death processes by the various tissues of the body. Due to its multiple tissue origins and easy collection, cfDNA appears to be a suitable matrix for searching for low mosaic Y chromosome sequences in patients with Turner syndrome.

The main objective of the study is to develop a cfDNA-based test to look for Y chromosome sequences in 50 patients with Turner syndrome. The secondary objectives are to determine the mosaic detection threshold of this test and to compare the performance of this test with the fluorescence in situ hybridization (FISH) technique used in routine diagnosis.

This study will assess the detection sensitivity of this test and its relevance in a clinical context.


Eligibility Criteria:
Inclusion Criteria:

* patient aged 2 to 74 years
* with a diagnosis of Turner syndrome confirmed by karyotype
* who have given their consent or whose legal representative(s) have given their consent(s) consent(s) to participate in the study
* affiliated to the French Social Security system or benefiting from such a system

Exclusion Criteria:

* male phenotype
* patient or legal representative(s) with comprehension difficulties (linguistic, etc.)
* patients covered by articles L.1121-5 to L.1121-8 of the CSP (French Public Health Code)
Pilot Study to Evaluate the Safety and Efficacy of Ariva® Silver Wintergreen in Reducing Cigarette Craving in Smokers

Study to determine the safety and effectiveness of Ariva® Silver Wintergreen lozenge on reducing craving for a cigarette in daily smokers.

Each subject will be given an Ariva® Silver Wintergreen lozenge or a Silver Wintergreen lozenge, which contains only silver salt, on a random basis.

Once the lozenge has dissolved in the mouth, subjects will smoke one of their own cigarettes, and will answer questions about the experience and their craving for a cigarette.

After a washout period, each subject will repeat the steps with the second type of lozenge.

Eligibility Criteria:
Inclusion Criteria:

* healthy adult smoker
* smoking for at least 5 years
* smoking at least one (1) pack of cigarettes a day
* interest in quitting smoking

Exclusion Criteria:

* known allergy to silver or silver salts
* pregnant or breast-feeding
* current drug or alcohol abuse, and/or history of drug or alcohol dependence within 3 months of study
Relevance of Plasma PCSK9 Concentration as a Biomarker in Acute Coronary Syndrome.

PCSK9 (Proprotein convertase subtilisin kexin type 9) plays a key role in LDL-cholesterol (LDLC) metabolism by inhibiting LDL receptor (LDLR) at post-transcriptional level. PCSK9 loss of function mutations are associated to decreased LDLC levels and a cardiovascular protection. In this context, the development of pharmacological inhibitors of PCSK9, in association with statins treatment, represents a major therapeutic issue for LDLC modulation. It was previously shown that PCSK9 plasmatic concentration correlated with plasmatic LDLC, TG and glucose concentrations. However, no data are available on predictive value of PCSK9 plasmatic level concerning coronary disease severity.

The main objective of this study is to determine whether plasmatic PCSK9 concentration is linked to coronary damage severity in patients with acute coronary syndrome.


Eligibility Criteria:
Inclusion criteria:

* more than 18 years old
* Acute coronary syndrome (ST+ or ST-)
* 2 groups of patients: with statin, and without statin treatment

Exclusion criteria:

* Patient who had cancer during the last 5 years or with cancer in progress
* Patient with severe infection in progress
* Hepatic failure (TP\<50%)
* Severe kidney failure
* Patient unable to give his consent to the study
Milk-induced Gastrointestinal Symptoms in Infants

Various digestive manifestations are common in infants less than 6 months and have a significant impact on morbidity and quality of life of the family. In a prospective study on more than 2800 Italian infants followed by 0-6 months of life, it was determined that 55% of these children had gastrointestinal symptoms such as regurgitation (23%), colics (20%), constipation (17%) or poor weight gain (15%). However, these symptoms are not very accurate, and their cause is often difficult to determine. Frequently, the pediatrician will exclude cow's milk protein in infant feeding, but without a clear etiological diagnosis was asked. This measure causes significant additional costs through the use of extensively hydrolyzed milk specifically for children and involves an elimination diet of all foods containing cow's milk sometimes for several years. This can negatively influence the growth of the child.

If the involvement of milk in these pathologies is suggested by some early studies (35% for colics, 68% in constipation, 42% in gastroesophageal reflux), it is unclear in the current state of knowledge if these gastrointestinal symptoms are actually due to an "allergy" to milk. Moreover, there is no validated diagnostic test for non-IgE-mediated gut allergy. However, various tests have proven their effectiveness in the investigation of non IgE-mediated allergy (eg. LAT, patch tests) and will be used in this study.


Eligibility Criteria:
Inclusion Criteria:

* Infants 0-6 month old with at least one of the following symptoms : constipation, gastroesophageal reflux, colics

Exclusion Criteria:

* Prematurity
* exclusive breastfeeding
* Other cause for symptoms
Endometrial Cancer Recurrence in Patients Taking Metformin

Given the early literature available and its biological plausibility as an inhibitor of the mammalian target of rapamycin (mTOR) protein, it is hypothesized that women with endometrial cancer who take metformin for non-cancer related reasons have a lower cancer recurrence rate compared to women not taking metformin. The primary goal of this study is to determine whether metformin use is associated with a decrease in the rate of endometrial cancer recurrence. Secondary objectives are to assess whether women with endometrial cancer taking metformin have longer progression free survival and overall survival than those that do not take metformin.

This is a retrospective chart review study. Medical records are reviewed and data collected through the hospital's electronic medical record (EMR). Participants are women that had definitive treatment for endometrial cancer between 2016-2020 at WellSpan York Hospital Department of Gynecologic Oncology. Participants are identified and their chart reviewed for demographic data of age, race, comorbid conditions, and use of metformin. Possible confounding information is documented, including chemotherapy status, radiotherapy status, cancer and tumor type, grade, and stage, available genetics information, medications at the time of cancer diagnosis, and medication durations. Those patients who had cancer recurrence are identified. Recurrence data including type, time interval, additional treatment are collected. Recurrence is defined as any recurrence validated by clinical, imaging and histological data and can be identified based on the cancer registry. Recurrence rate in participants that took metformin vs. those that did not is calculated. Time to endometrial cancer recurrence is calculated. Progression free survival and overall survival are calculated. Statistical analysis is performed to compare each of these outcomes between participants who took metformin vs. those that did not.

Eligibility Criteria:
Inclusion Criteria:

* Participants with endometrial cancer of all histologies treated in the WellSpan system from 2016-2020

Exclusion Criteria:

* Participants who underwent palliative treatment for endometrial cancer
Effect of the Bevel Direction of Puncture Needle on Success Rate and Complications During Central Venous Catheterization

To test the hypothesis that approaching the internal jugular vein with the needle bevel down would produce less injury to the vessel wall compared to the bevel up approach during central venous catheterization.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing surgery that requires the placement of a central venous catheter at the internal jugular vein

Exclusion Criteria:

* anatomical anomaly in the neck region
* recent history of central venous catheterization
Lundbeck TOMs Orthostatic Hypotension

Orthostatic hypotension (OH), which consists in a significant reduction in blood pressure levels upon standing from a seated position, may affect approximately one in three patients with Parkinson's disease (PD). It usually presents as dizziness, lightheadedness, feeling faint, or feeling like you might black out while standing. This can significantly impact the quality of life (QoL) of PD patients, resulting in difficulties with balance, walking, and increased risk of falls. The main aim of this study is to evaluate whether the use of technological devices (a computerized system for analyzing abnormalities in walking in clinical settings and a wearable sensor to detect changes in postural unsteadiness in the home environment) may improve the detection of complications and the response to medical therapies for OH in patients with PD.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic Parkinson's Disease, meeting UK Brain Bank criteria for at least 3 years
* Hoehn and Yahr (H\&Y) stage I-III
* Age between 30 and 80 years old (both inclusive)
* Stable dosage of dopaminergic medications for at least 4 weeks
* Orthostatic Hypotension, defined as a fall in systolic BP ≥ 20 mmHg or diastolic BP ≥ 10 mmHg within 3 minutes of standing
* Willingness and ability to comply with scheduled visits

Exclusion Criteria:

* Diabetes mellitus or other diseases potentially associated with autonomic dysfunction
* Treatment with antihypertensive drugs or with alpha-adrenergic antagonists
* Cognitive impairment, defined as a score \< 24 at the Montreal Cognitive Assessment (MoCA)
* Any atypical signs lowering the diagnostic certainty for PD
* Lack of postural reflex defined as a score \> 2 at the MDS-UPDRS item 3.12 (recover at the pull test)
* Severe levodopa induced dyskinesia, defined as an MDS-UPDRS item 4.2 \> 2 (functional impact of dyskinesia)
A Study Comparing Short-course Antifungal Therapy (SCAT) 7 Day vs Standard 14 Day Antifungal Therapy for Uncomplicated Candidemia

The goal of this clinical trial is to assess whether a seven-day course of standard of care (echinocandin) antifungal therapy is non-inferior to a 14-day course of echinocandin antifungal therapy in patients with uncomplicated candidemia in terms of clinical, mycologic, adverse events and all cause mortality.


Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 18 years of age
2. Uncomplicated candidemia (positive blood culture only). No evidence of invasive candidiasis at day 1 or until day 7.
3. Received \< 5 days of prior antifungal therapy
4. Informed Consent for randomization
5. Patients that did not consent to randomization have consented to be used as a natural history (controls) and will allow collection of available data from the medical record.

Exclusion Criteria:

1. Inadequate source control (e.g., unable to remove endovascular devices, urinary catheters).
2. Invasive candidiasis of any type (e.g., deep seated candidiasis from sources other than blood)
3. Abnormal LFTs \> 10-fold
4. Greater than 5 days of prior antifungal therapy
5. Endovascular devices that cannot be removed.
6. Immunocompromised patients (AIDS/HIV; solid organ transplant, bone marrow transplant patients, oncology patients receiving chemotherapy, neutropenic patients (ANC of \< 1,500 cells/L
7. Neutropenic at time of consent (what does this mean)
8. Break-through candidemia (people with prior candidemia who relapsed) after treatment with antifungal therapy)
9. Unable to provide informed consent from either the patient or legally authorized authority (LAR)
10. Expected mortality within 96 hours
Study In Adults And Adolescents With Seasonal Allergic Rhinitis

The purpose of the study is to compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray in the treatment of seasonal allergic rhinitis. Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly referred to as "hay fever", it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.


Eligibility Criteria:
Inclusion criteria:

* Informed consent.
* Outpatient.
* Females must use appropriate contraception.
* Diagnosis of seasonal allergic rhinitis.
* Adequate exposure to allergen.
* Able to comply with study procedures.
* Literate.

Exclusion criteria:

* Significant concomitant medical condition.
* Use of corticosteroids, allergy medications, or tobacco.
* Clinically significant abnormal ECG.
* Laboratory abnormality.
* Positive pregnancy test.
* Allergy to any component of the investigational product.
Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Allergic Conjunctivitis.

The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline ophthalmic solution compared to vehicle and its individual components in alleviating the signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months.
* Calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as measured using the ETDRS chart.
* Positive bilateral conjunctival allergen challenge(CAC)reaction within 10 minutes of instillation of the last titration of allergen at visit 1.
* Positive bilateral CAC reaction in at least 2 out of 3 time points at visit 2.

Exclusion Criteria:

* Known contraindications or sensitivities to the study medication or its components.
* Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
* Use of disallowed medications during the period indicated prior to study enrollment or during the study.
A Phase I/II Study of Intralesional Recombinant Tumor Necrosis Factor in Patients With AIDS-Related Cutaneous Kaposi's Sarcoma

To evaluate tolerance, toxicity, and preliminary evidence of antitumor efficacy of intralesionally administered tumor necrosis factor (TNF) and to define a maximum tolerated dose (MTD) for single intralesional injections. In addition, to assess the effects of TNF injections on Kaposi's sarcoma (KS) lesions as measured by P-32 magnetic resonance spectroscopy.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Biopsy-proven Kaposi's sarcoma (KS) with multiple cutaneous lesions.
* Minimum life expectancy of 3 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Clinically significant cardiac disease.
* Known hemorrhagic diathesis or active bleeding disorder.
* Clinically apparent vascular disease.
* Known lipoprotein disorders.
* History of seizure disorder or central nervous system (CNS) metastasis.
* Additional malignancy.

Concurrent Medication:

Excluded:

* Cardiac agents.
* Anticoagulants.
* Thrombolytic agents.
* Nonsteroidal anti-inflammatory drugs.
* Corticosteroids.
* Aspirin.
* Vasodilators.

Patients with the following are excluded:

* Additional malignancies or other conditions listed in Patient Exclusion Co-Existing Conditions.

Prior Treatment:

Excluded within 4 weeks of study entry:

* Chemotherapy.
* Radiotherapy.
* Immunotherapy.
Dezoxide Suppresses Sufentanil-induced Cough

Dizocine (0.03 mg/kg) or saline followed by sufentanil 0.4ug/kg was administered, and induction was completed with 3 min of observation. Heart rate and mean arterial pressure (MAP) were recorded before induction of anesthesia, before and 1 min after intubation, and side effects during induction, such as vomiting, hypoxemia (SpO2 \<90%), or other expected effects. The number of coughs was recorded in both groups, and the severity of cough was defined as follows: mild, 1-2 coughs; moderate, 3-4 coughs; severe, 5 or more coughs.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted for elective valve surgery, artificial vessel replacement or coronary artery bypass graft surgery; Age 18\~80 years old; Sex is not limited; ASA class II\~III; NYHA Class II-III; Patients or their family members have signed the clinical trial informed consent form

Exclusion Criteria:

* Upper respiratory tract infection within the last two weeks; Long history of smoking; chronic obstructive pulmonary disease; Highly reactive airway diseases such as bronchitis and asthma; Presence of high cranial pressure, high eye pressure, pulmonary alveolus; Malignant tumor, hematological disease, severe liver and kidney dysfunction, recent serious infection, etc.
Effect of Closed-chain Shoulder Girdle Scapular Depression Exercise on Shoulder Impingement Syndrome

forty patients will be assigned randomly into 2 equal groups Study group (n=23) will receive "closed-chain shoulder girdle scapular depression exercise" in addition to Stretching for posterior capsule \& pectoralis minor, Eccentric exercise for external rotators and Strength exercises for serrates anterior and low intensity ultrasound Control group B (n=23) will receive "shoulder girdle depression against manual resistance exercise" in addition to stretching for posterior capsule \& pectoralis minor, eccentric exercise for external rotators and Strength exercises for serrates anterior and low intensity ultrasound .

The exercise program will consist of 3 sessions / week for 5 weeks

BACKGROUND:

Patients with shoulder impingment syndrome report disability, especially during overhead movements, which may hinder activities of daily living .

Muscular strengthening training influences the resting position and scapular movement pattern of subjects with shoulder impingement syndrome and improve function of the affected shoulder.

Therefore, the focus of treatment for the syndrome is on performing exercises, including stretching, strengthening, and neuromuscular control exercises.

Although multiple types of exercise, such as scapular stability exercises, strengthening of the rotator cuff through range, and flexibility exercises for the anterior and posterior shoulder exercise is effective in the management of patients with shoulder impingement syndrome, there is not enough evidence to say whether one mode of exercise is superior to another.

RESEARCH QUESTION:

Are there any difference between closed-chain shoulder girdle scapular depression exercise and shoulder girdle depression against manual resistance exercise on patients with shoulder impingement syndrome

METHODS:

forty patients will be assigned randomly into 2 equal groups Study group (n=23) will receive "closed-chain shoulder girdle scapular depression exercise" in addition to Stretching for posterior capsule \& pectoralis minor, Eccentric exercise for external rotators and Strength exercises for serrates anterior and low intensity ultrasound Control group B (n=23) will receive "shoulder girdle depression against manual resistance exercise" in addition to stretching for posterior capsule \& pectoralis minor, eccentric exercise for external rotators and Strength exercises for serrates anterior and low intensity ultrasound .

The exercise program will consist of 3 sessions / week for 5 weeks

Eligibility Criteria:
Inclusion Criteria:

* Patients aged from 25 to 45 years old.
* Patients with shoulder impingement stage I \&II as judged by criteria of neer classification.
* Patients diagnosed by orthopedic surgeon with shoulder impingement, the diagnosis will be confirmed by positive Neer and Hawkins tests.

Exclusion Criteria:

* History of cardiac diseases or dyspnea on exertion
* Patients with cervical radiculopathy.
* Patients with shoulder instability.
* Patients with frozen shoulder.
* Acute shoulder trauma.