cyrilzakka/clinical-trials huggingface dataset:
Influence of Trigger Threshold on Controlled Twitch Mouth Pressure

The inspiratory pressure trigger is essential when assessing the twitch mouth pressure (Tw Pmo) for avoiding glottic closure. However, the difference in inspiratory pressure trigger threshold may influence the values of Tw Pmo. We sought to determine the trigger threshold for healthy subjects and COPD patients.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of COPD
2. Stable with no episodes of exacerbation within the previous 2 months
3. Do not currently being treated with oral corticosteroids

Exclusion Criteria:

1. Not stable within the previous 2 months.
2. Patients with COPD were currently being treated with oral corticosteroids
Living Donation and Kidney Transplantation Information

The purpose of this study is to increase awareness and knowledge regarding the risks and benefits of kidney transplantation and living donation amongst patients seeking kidney transplantation and their family and friends in Buffalo, New York.

This prospective randomized parallel controlled trial of kidney transplant candidates receiving and educational intervention and standard of care education versus standard of care education only to improve informed decision making about kidney offers.

Eligibility Criteria:
Inclusion Criteria:

* be 18 years or older,
* understand and read English (or have a support person that helps them)
* have acceptable vision to watch videos
* be able to give consent

Exclusion Criteria:

* incarcerated
* involved in the former modeling phase of animation development.
A Study of LY900014 in Elderly and Younger Adult Participants With Type 1 Diabetes Mellitus

The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in elderly and younger adults with type 1 diabetes mellitus.

Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be between 3 to 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Are male or female participants with Type 1 Diabetes Mellitus (T1DM)
* Have a body mass index (BMI) of 18.5 to 30.0 kilogram per meter square (kg/m²)
* Have a glycated hemoglobin (HbA1c) less than (\<)9.0 percent (%)
* Have had no episodes of severe hypoglycaemia in the last 6 months

Exclusion Criteria:

* Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from T1DM), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
* Have a history of renal impairment
* Have a history of deep vein thrombosis of the leg or repeated episodes of deep leg vein thrombosis in first-degree relatives
* Have proliferative retinopathy or maculopathy and/or severe neuropathy
The Effect of Endovascular Thrombectomy on Autonomic Nervous System in Patients With Large-vessel Ischemic Stroke

The autonomic nervous system (ANS), regulating involuntary physiologic processes including heart rate and blood pressure, is affected by changes in the cerebral vessels like carotid artery stenosis, occlusion, carotid artery stent and endarterectomy.

Until now, no data concerning autonomic nervous system in patients with acute intracranial large artery occlusion and thrombectomy is available. Due to the known effect on ANS in case of pathologies of extracranial brain supplying arteries it is highly suspected that intracranial large artery occlusion and thrombectomy can affect the ANS as well.

The aim of this project is to determine autonomic parameters during and after thrombectomy in patients with large cerebral artery occlusion. The project is a prospective descriptive pilot study at the University Hospital Tulln. 20 patients will be assessed during and after thrombectomy up to three months post intervention. A combination of autonomic parameters, hemodynamic parameters and clinical outcome will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Age: \> 18 years of age
* Acute ischemic stroke with large extra- and intracranial artery occlusion and intraarterial mechanical thrombectomy treatment.
* Successful recanalization after thrombectomy with TICI 2b or 3.
* Informed consent by the patient

Exclusion Criteria:

* Informed consent not possible within 7 days after thrombectomy due to impaired awareness or speech disturbances.
* Permanent stent during thrombectomy.
* Severe complications, such as severe intracranial hemorrhage, during or after thrombectomy including prolonged ICU stay.
* Modified rankin scale (mRS) over 3 before admission.
* Diagnosis of dementia with mini mental state examination (MMSE) \< 26 points in the medical history
* Intracranial hypertension in the medical history or brain imaging.
* Patent foramen ovale in the medical history.
* Glaucoma in medical history.
* Inability to complete study visits
Exploration of Therapeutic Strategies for NeoRAS Wild-type Metastatic Colorectal Cancer Based on Circulating Tumor DNA

Following systemic therapy in metastatic colorectal cancer(mCRC),RAS (including KRAS, NRAS and HRAS gene) status may change from a mutant(MT) to a wild-type(WT),a phenomenon known as "NeoRAS WT"mCRC.NeoRAS WT can be detected by longitudinal circulating tumor DNA(ctDNA) analysis.Therefore, this prospective phase II Study was design to explore the detection rate of peripheral blood ctDNA testing for NeoRAS WT and its guiding value for subsequent treatment for mCRC.


Eligibility Criteria:
Inclusion Criteria:

1. Metastatic colorectal cancer with tissue RAS mutation-type;
2. ECOG (Eastern Cooperative Oncology Group) performance score is 0-1;
3. Obtaining informed consent;
4. Surgical specimens or punctured tissue specimens containing tumors can be obtained; 10ml of peripheral blood can be obtained

Exclusion Criteria:

1. The pathology was not confirmed by colonoscopy biopsy or biopsy of metastasis;
2. Colorectal cancer patients with clinical stage I-III;Patients with RAS wild-type metastatic colorectal cancer confirmed by histological genetic testing;Lack of adequate organ functions, such as severe abnormalities in blood, liver and kidney function
Quantitative Parameters of HLA-DQ Antibodies in Lung Transplantation

The aim is to compare the quantitative parameters of de novo anti-HLA DQ Donor Specific Antibodies (DSA), determined at the time of their discovery by surface plasmon resonance (SPR), between recipients that developed a Chronic Lung Allograft Dysfunction (CLAD) for the 2 years following DSA apparition and those who did not. If concentration, kinetics and/or affinity parameters of anti-DQ DSA are associated with CLAD development, new, non-invasive prognostic biomarkers of humoral rejection in lung transplantation will be discovered .

After lung transplantation the production of de novo DSA directed against HLA-DQ molecules is associated with CLAD and graft loss. The most used assay for serum DSA detection is the Single Antigen Luminex® (SAG), which provides a semi-quantitative fluorescence value, the MFI, used as a surrogate of DSA "strength". But MFI is not perfectly associated with CLAD development. We developed a method using SPR allowing the concentration, kinetics (ka, kd) and affinity parameters (KD) of anti-DQ DSA to be determined. These quantitative parameters could represent biomarkers finely associated with CLAD. The way this parameters evolve (stability, increase or decrease) with time could also impact on DSA pathogenicity. We will compare the quantitative parameters of de novo anti-HLA DQ DSA, determined at the time of their discovery, between recipients that developed a CLAD for the 2 years following DSA apparition, and those who did not. The association between quantitative parameters of DSA and graft loss, their evolution and its association with CLAD and graft loss, and their correlation with SAG MFI will be also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Patient transplanted between 01/01/2001 and 31/07/2016
* Patient with immunodominant anti-HLA DQ de novo DSA developed before 08/2016
* Patient for who sufficient remaining serum quantity is available in usual care biobank
* non-opposition of the patient

Exclusion Criteria:

* preformed DSA at the transplantation;
* Non immunodominant DQ DSA ;
* Insufficient serum quantity in usual care biobank
* Inability to determine the date of DSA apparition at around one year
* opposition of the patient
Effectiveness and Safety of Implantable Intrathecal Systems for Refractory Pain in Spain (INTRATHECAL-RENASED)

Refractory pain is a prevalent condition that negatively affects patients' quality of life. Intrathecal implantable systems have been proposed as a treatment option for refractory pain. However, real-world data on the effectiveness and safety of these therapies in Spain are scarce. This study aims to obtain real-world data on the effectiveness and safety of intrathecal implantable systems for refractory pain treatment in Spain.

All Spanish hospitals that implant intrathecal systems for refractory pain will be invited to participate in the study. Patients will be recruited before the procedure, and before providing data to the registry, the study will be explained to them, and they will sign an informed consent form. Demographic data related to the pathology and procedure will be collected. Follow-up will be conducted at three and twelve months after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Chronic refractory pain patients candidates for treatment with an implantable neurostimulation system.
* Accept to participate in the study and sign informed consent.

Exclusion Criteria:

* Patients in whom it would be difficult to complete follow-up.
* Insufficient understanding of the Spanish language.
* Pregnancy.
Efficacy and Safety Study of ATs in Patients With Dry Eye Syndrome

The purpose of this study is to determine whether artificial tears are safe and effective in the treatment of Dry Eye Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Male and female adults aged 18 years and over.
* Subjects should diagnosed as dry eye syndrome in both eyes or one eye, keratoconjunctivitis sicca (KCS), or should have at least a 3-month history diagnosed as dry eye syndrome due to Sjögren syndrome.
* Subjects must agree to discontinue all artificial tears from Screening for 2 weeks
* Subjects must discontinue lens wear one week before Screening and agree not to wear contact lenses during the entire study.
* Subjects who have taken Restasis® are eligible for inclusion if they have not used Restasis® during the 4 weeks prior to Screening
* Subjects must provide signed informed consent prior to participation in any study-related procedures
* Subjects who dose not Participate in same clinical trial within 6 month prior to Screening.

Exclusion Criteria:

* Pregnancy or lactation.
* Females of childbearing potential who are not using systemic contraception,are not postmenopausal (≥ 1 year), or are not surgically sterilized.
* Ocular surgery (of any type, including laser surgery) or ocular trauma within the 4 months prior to Screening.
* Any active inflammation of the eye not due to KCS
* Other diseases or characteristics judged by the investigator to be incompatible with the assessments needed in this study or with reliable instillation of the study medication.
Study the Effects of CYP2C Polymorphisms on the Pharmacokinetics and Pharmacodynamics of Glipizide

The aims of this study were to investigate the effects of CYP2C9 and CYP2C19 polymorphisms on the pharmacokinetics and pharmacodynamics of glipizide in healthy Chinese subjects.

Compared with CYP2C19, CYP2C9 polymorphism appears to have a dominant role in glipizide pharmacokinetics and pharmacodynamics in vivo. This indicated that dose adjustment based on CYP2C9 genotype may improve antidiabetic treatment.

Eligibility Criteria:
Inclusion Criteria:

* nonsmokers and in good health

Exclusion Criteria:

* family history of diabetes mellitus
* taking any drug, alcohol, foods containing caffeine, or grapefruits and juice before study
Centralized Pan-Russian Survey on the Undertreatment of Hypercholesterolemia

The purpose of the study is to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the All-Russian Scientific Cardiology Society guidelines/ the 4th Joint European Task Force guidelines.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be 18 years of age or older of either gender or race.
* Subject must provide informed consent and comply with the survey procedures.
* Subject is on lipid lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks.

Exclusion Criteria:

* Subjects who are unwilling or unable to provide informed consent
Appraisal of the Modified Cancer Cachexia Index in Locally Advanced Gastric Cancer Patients Undergoing Neoadjuvant Chemotherapy

In this study, consecutive 600 patients with LAGC(cT2-4NanyM0) who underwent NACT between Jan. 2010 and Jun. 2022 were identified from two tertiary hospitals. The mCXI was constructed based on Random Forest model, calculated as (post-NACT L3 subcutaneous adipose tissue area \[SAT\])×(post-NACT serum albumin \[ALB\])/(post-NACT platelet count \[PLT\]). Patients were categorized into two subgroups: mCXI-low and mCXI-high. mCXI is associated with the overall prognosis in patients with locally advanced gastric cancer underwent neoadjuvant chemotherapy, is superior to traditional CXI, and may serve as a decision-making tool for guiding personalized postoperative adjuvant chemotherapy.

This is a multicenter retrospective cohort study

Eligibility Criteria:
Inclusion Criteria:

* (1) locally advanced gastric cancer (cT2-4NxM0) with clinical staging before neoadjuvant chemotherapy, (2) no history of other malignant tumors, (3) no evidence of distant metastasis or invasion of adjacent organs, and (4) patients who underwent radical gastrectomy following neoadjuvant chemotherapy.

Exclusion Criteria:

* (1) history of gastric surgery; (2) acute cardiovascular disease (such as cerebrovascular or coronary artery injury) within the past three months; (3) emergency surgery; (4) active infection or severe systemic immunodeficiency; and (5) incomplete serological, computed tomography, or anthropometric data.
Validation Study of Physical Measurement of Tophi

The purpose of this study is to determine the inter- and intra-rater reproducibility of direct physical measurement of tophus nodules in subjects with gout.

Gout is a chronic urate crystal deposition disorder. Left untreated, gout may result in progressive disease characterized by joint and bone destruction from tophaceous deposits and renal impairment due to gouty nephropathy. Hyperuricemia, defined as a serum urate concentration greater than 7.0 milligrams per deciliter (mg/dL), is the underlying metabolic aberration leading to urate crystal deposition in gout. Gout has several clinical presentations, including: recurrent acute attacks of inflammatory arthritis; deposition of monosodium urate monohydrate crystals in joints, bones and even parenchymal organs (tophaceous gout); renal impairment; and uric acid nephrolithiasis.1 As serum urate levels increase beyond greater than 7.0 mg/dL, the risks for gouty arthritis or for renal calculi increase.

Febuxostat is a 2-aryl-thiazole derivative chemically engineered as a novel xanthine oxidase/dehydrogenase inhibitor. Febuxostat is being developed as an orally administered agent for the management of hyperuricemia in patients with gout.

Subjects with palpable tophi \>10 millimeters (mm) in length and width and as round as possible will have the tophus measured on two separate visits by two different raters to assess the inter- and intra-rater reproducibility of direct physical measurement.

Eligibility Criteria:
Inclusion Criteria:

* Must have at least 1 palpable gouty tophus nodule in the foot/ankle, hand/wrist, or elbow, confirmed as gouty by prior diagnosis according to ACR criteria.
* The tophus must be solid, round, non-tender, intact, and larger than 10mm in both length and width.
* Joints nearest and immediately adjacent to the selected tophus must not be acutely inflamed.
* Must be on stable treatment for gout with no medication changes in the past 30 days.

Exclusion Criteria:

* Must be able to return to the clinical site within 10 days.
* Must not have allergy to ink.
A Study to Investigate the Efficacy, Safety and Tolerability of Nexagon® as a Topical Treatment for Subjects With Venous Leg Ulcers

This study is for subjects with a venous leg ulcer. The study is being done to determine if NEXAGON plus compression bandaging is more effective that placebo plus compression bandaging.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of venous leg ulceration supported by venous duplex ultrasonography demonstrating venous reflux \> 0.5 seconds
2. Ankle brachial index of \> 0.80
3. Venous Leg Ulcer (VLU) area greater than 2 cm2 and less than 20 cm2
4. Compliant with and able to tolerate high compression bandaging
5. VLU present for \> 30 days prior to study entry
6. VLU is full thickness
7. The subject is willing and able to give informed consent

Exclusion Criteria:

1. Decrease or increase in the ulcer surface area by more than 40% during the 14 day run-in period
2. More than 75% of the VLU is on or below the malleolus
3. Presence of a non-study ulcer within 1.5 cm of the VLU
4. A VLU which shows signs of clinical infection or has cellulitis
5. The VLU wound bed has exposed bone, tendon or fascia
6. BMI \> 45.0 kg/m2
7. Subject is not ambulatory
8. Subjects who have a past or present disease that, which as judged by the Investigator, may affect the safety of the subject or the outcome of the study
9. Cancerous cells in the VLU
10. HbA1c \>10%
11. Blood biochemistry \>3x upper limit of normal
12. Heart failure NYHA class III or IV
13. Subjects on renal replacement therapy
14. Immunocompromized subjects
Sexual Function Before and After Bariatric Surgeries.

To assess sexual function before and the impact of weight loss after bariatric surgery among obese men with sexual dysfunction.

Obesity is a worldwide prevalent problem which is currently considered a pandemic disease. It is intimately related to several comorbidities that negatively impact physical and mental health. Male sexual dysfunction is not uncommon in people with obesity. This could be attributed to many obesity-associated conditions as diabetes mellitus (DM), hypertension (HTN), and mental and social impairment. Obesity indirectly affects male sexual function by inducing many comorbidities associated with sexual dysfunction. Obesity is also a complex endocrine disorder that can independently alter sexual function through the disruption of various sex hormones. Men with morbid obesity often suffer from deep but reversible sexual dysfunction. Several managements have been introduced to deal with obesity. Dietary intervention, medications, physical exercise are widely used in case of mild and moderate obesity. Meanwhile, bariatric surgery has become the most effective treatment strategy for morbid obese patients which can bring great weight reduction and is expected to ameliorate the comorbidities. Mora et al.'s prospective study showed a bariatric surgery-related significant increase in the IIEF score at 1 year postoperatively. This was found also by the Groutz et al. and Kun et al. However, in a retrospective study by Rosenblatt et al., there was no significant increase in the IIEF scores following RYGB surgery in 23 male patients. Similarly, Sarwer et al., in their prospective study, found that despite the increased postoperative IIEF scores, this difference lied out of significance except for the overall satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* The study will involve fifty-five obese male patients "those indicated for bariatric surgery" complaining from sexual dysfunction with score ≤ 21 in the International Index of Erectile Function-5 (IIEF-5) questionnaire.

N.B. Indication for bariatric surgeries when they have BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbidities.

Exclusion Criteria:

* Patients who are not married;
* Those with severe psychic illness.
* And those with congenital or acquired penile problems interfere with sexual intercourse.
Accurate WiFi-Based Localization of Dementia Patients For Caregiver Support:

In this Phase II SBIR project we will enhance a wireless WiFi-based insole that was designed and successfully tested during a Phase I trial with elderly persons with dementia and their caregivers, and then investigate its efficacy in terms of caregiver activity, burden, and quality of life in Phase II. Evaluation will use semi-structured interviews and participant observation data collected from professional and family caregivers of patients with moderate or mild dementia.

The efficacy of the Activlink system offering localization information to improve caregiver will be evaluated in two studies. Study 2a will use the insole system with dementia patients residing in skilled or memory care. Data regarding caregiving activity will be collected from their paid professional care providers. Study 2b will use participant localization data collected on 80 independently dwelling mild dementia patients. In this case data will be collected from their unpaid family caregivers. Both studies will result in evaluating the efficacy of the WiFi-based insole to provide caregivers with augmented patient awareness, helping to improve their immediate quality of life by reducing their direct burden of continuous oversight of their person in care.

Eligibility Criteria:
Inclusion Criteria:

Persons With Dementia Resides in memory care or skilled nursing

* Moderate dementia (MMSE of 10-18)
* Ambulatory (without or with cane, walker or wheelchair assist)
* A legal proxy that can provide consent

Persons With Dementia Resides in independent living setting in community.

* Mild dementia (MMSE of 19-25)
* Ambulatory (without or with cane, walker or wheelchair assist).
* Has a legal proxy that can provide consent.

Care Partners

* Speaks English
* Be 21 years of age or over
* Has at least three times per week direct contact with person with dementia (PWD)
* Consents to participate in the study

Exclusion Criteria:

* Is not fluent in written or spoken English
* Indicate an unwillingness to use the Activlink
* History of Major Mental Illness for patient or caregiver
Probiotics for Treatment of Chalazion in Adults

There is growing evidence encouraging probiotics use in several diseases. The aim of the investigator's study is to define the possible beneficial impact of probiotics on adults suffering from chalazia.

Prospective comparative pilot study on 20 adults suffering from chalazion randomly divided into two groups. The first group, received conservative treatment with lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days. The second group, in addition to the conservative treatment, received a mixture of probiotic microorganisms once a day up to 3 months. Chalazia were classified according to their size into three groups: small (≤2 mm), medium (2-4 mm), or large (\>4 mm). When conservative treatment (with and without probiotics supplementation) failed to resolve the lesion, invasive methods were used, (intralesion steroid injection in medium size chalazion and surgical incision and curettage for the largest ones).

Eligibility Criteria:
Inclusion Criteria:

* history of rapid onset of painful inflamed mass that had reached a stationary size for more than 2 months
* clinical appearance and location of the lesion

Exclusion Criteria:

* eyelid infection
* chalazion duration \< 1 month
* nonpalpable chalazion
* suspicion of malignancy
* comorbidities (constitutional atopy and seborrheic dermatitis, hormonal dysfunction, presence of irritable bowel disease, infectious mainly related to Staphylococcus aureus and Propionibacterium acnes, demodex mite infestation, vitamin A deficiency, arterial hypertension, diabetes and pregnancy)
* personal habits (smoking, eating disorders, etc.)