cyrilzakka/clinical-trials huggingface dataset:
Accelerated Aging in Middle-Aged Men With Sleep-disordered Breathing.

Obstructive Sleep Apnea Syndrome (OSAS) regardless of any other associated risk factor can lead to accelerated aging. The study of aging-related Obstructive Sleep Apnea (OSA) is difficult because of associated risk factors (diabetes, hypertension, dyslipidemia, obesity), promoting themselves aging. The investigators propose to compare a group of OSAS patients free of any associated pathology, to subjects matched for age, sex, smoking and body mass index (BMI)


Eligibility Criteria:
Inclusion Criteria

Patient:

* Men aged 20 to 65 years
* Having polysomnography in the Functional Explorations department, Sleep Laboratory, Hospital Henri Mondor, Creteil
* With an AHI \> 5 / h

Healthy volunteers:

* Men aged 20 to 65 years
* With an AHI ≤ 5 / h

Exclusion Criteria

All subjects:

* Known cardiovascular risk: hypertension treated, diabetes treated, dyslipidemia treated,
* Known cardiovascular disease associated (heart failure, rhythm disorder ...)
* Known respiratory diseases
* Known neoplastic pathology, known chronic inflammatory disease
* Psychiatric pathology treated
* Medication
* Not affiliated to the French social health care system
* Major protected person
* Private person of liberty
* People in emergency situation
* Patient refusing to participate in the study
The Effect of Combination of Dapagliflozin and Sildenafil in Treatment of Heart Failure Patients with Secondary Pulmonary Hypertension

This study aims to determine the efficacy of sildenafil (improve PAH) as an add-on therapy to dapagliflozin in the treatment of heart failure patients with secondary pulmonary arterial hypertension and compare the result with monotherapy dapagliflozin


Eligibility Criteria:
Inclusion Criteria:

patients with established heart failure with secondary pulmonary hypertension seen by a primary care provider to diagnose a heart disease, the patient's symptoms which may experience:

* Dizziness or fainting
* Heart palpitations, which may feel like your heart fluttering or skipping beats
* Shortness of breath

Exclusion Criteria:

* Patients with a history of severe allergic reactions or hypersensitivity to sildenafil, dapagliflozin, or related medications.
* Individuals with contraindications to the use of sildenafil or dapagliflozin.
* Patients with pulmonary arterial hypertension (PAH) due to conditions other than heart failure (e.g., idiopathic PAH).
* severe hepatic impairment
* aged less than 18 years.
* valvular heart disease .
* Patients with a known or suspected history of non-compliance with medical treatment or inability to adhere to study procedures.
* life expectancy of less than 6 months .
* Pregnant or breastfeeding women
Evaluating the Impact of Year Long, Augmented Diabetes Self Management Support

Improving diabetes social support is associated with health improvement benefits. This study is a prospective randomized controlled trial comparing the effects of telephone-based diabetes self-management support (DSMS) compared with usual care, which includes diabetes self-management education (DSME), during a 1-year period. It will determine whether this specific model for providing on-going support to people with diabetes will better enable them to maintain the engagement in self-care behaviors, clinical improvements and diabetes-specific knowledge gained during the course of diabetes self-management education.

Diabetes self management support is telephonic and will be provided by health navigators at a central call center

Eligibility Criteria:
Inclusion Criteria:

* English or Spanish speaking
* Diagnosis of type 2 diabetes mellitus
* HbA1c \> 8
* Have not completed a diabetes self management education program in the past year

Exclusion Criteria:

* Current engagement in cancer treatment
* Diagnosis of end-stage renal disease
* Pregnant
* Receiving immunosuppressant therapy following transplant
* Diagnosis of serious mental illness
* Undergoing systemic treatment with prednisone
Phase 1 Dose-escalation PK/PD Trial in Advanced Cancer Patients

Primary Objective: To evaluate the safety of escalating oral doses of RDEA119, a MEK inhibitor, in advanced cancer patients.

Secondary Objectives:

* To describe the initial PK of different doses of RDEA119 when given once orally on Day 1 of the study
* To describe the PK of different doses of RDEA119 when given orally as continuous dosing.
* To examine the inhibition of MEK products (p-ERK), cytokine products, and other protein biomarkers
* To expand the MTD dose cohort to evaluate the safety, tolerability and PK/PD of the recommended Phase 2 dose
* To explore the presence of genotype, PD markers, cell growth and a marker of apoptosis, in paired tumor biopsy samples of patients' tumors pre-dose and during dosing in a minimum of 10 patients in the expanded cohort


Eligibility Criteria:
Inclusion Criteria: - Histological or cytological confirmed solid tumor. - Advanced metastatic or locally recurrent disease for which no proven effective therapy exists. - In the expanded MTD cohort, a minimum of 10 patients must have an accessible tumor that is amendable to biopsy (cut or needle) at the start and during the study. For patients not in the biopsy group, a block from the patient's original diagnostic biopsy/excision, if available, may be used for genotype analysis. - ECOG performance status of 0-1. - Life expectancy of \> or equal to 3 months. - Acceptable hematology, clinical chemistry, and coagulation laboratory values. - Patient must be acceptable for treatment and follow up according to the Investigator. - Patent must have agreed to and signed the Informed Consent. - Patient has within normal range cardiac function as measured by echocardiogram or MUGA scan. Exclusion Criteria: - Use of investigational agents or devices within the last 28 days. - Major surgery within 30 days of start of study. - Patients with documented CNS metastasis who are not off steroids and other CNS therapies - Evidence of uncontrolled active infections. - Other serious medical or psychiatric illness. - Significant cardiac dysfunction including congestive heart failure (NYHA Class III or IV); myocardial infarction or ventricular tachyarrhythmia within the last 6 months; major conduction abnormalities unless corrected with a cardiac pacemaker; prolonged QTc \>460msec. - Patients with known hypersensitivity to any of the drugs or components given in this protocol. - Pregnancy. - Women or men of childbearing potential not willing to use effective contraception, including barrier protection. - Patients with abdominal fistula, GI perforation, intra-abdominal abscess, or small bowel resection, any of which is within 6 months of study entry. - Patients with abdominal radiation resulting in chronic diarrhea. - Because RDEA119 is primarily metabolized by CYP3A4 and CYP2C19, inhibitors and inducers of these enzymes should be avoided. - Patients with known HIV infection will be excluded.
PF-06372865 In Subjects With Chronic Low Back Pain

PF-06372865 In Subjects With Chronic Low Back Pain


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Comparation Between Needles for EUS-guided Sampling of Solid Pancreatic Lesions

This is a randomized study in order to compare the diagnostic yield (primary outcome) of EUS-guided sampling of pancreatic solid lesions obtained with the 25-gauge Franseen and the 25-gauge standard needle in patients undergoing EUS-guided sampling of pancreatic solid masses without ROSE. Secondary outcomes are the number of extra passes with each needle required to reach adequate core, possibility to perform immunohistochemistry and the adverse event rate.

This is a randomized trial conducted at a unique center. The aim of this study is to compare the diagnostic yield (primary outcome) of EUS-guided sampling of pancreatic solid lesions obtained with the 25-gauge Franseen and the 25-gauge standard needle in patients undergoing EUS-guided sampling of pancreatic solid masses without ROSE. Secondary outcomes are the number of extra passes with each needle required to reach adequate core, possibility to perform immunohistochemistry and the adverse event rate.

Patients with a suspected solid pancreatic lesion larger than 15 mm, identified by CT or MRI and referred to EUS-guided sampling will be eligible for inclusion. Patients will be excluded in case of cystic lesion, or the lesion was not detected in EUS, or if the coagulation parameters are abnormal (INR\> 2, platelet count \< 50,000). The pancreatic mass will be puncture, for expert endoscopist, firstly with a needle according to randomization, followed by another one. Will be make a touch print with the specimen obtained with the needles and, subsequently, all the specimen will be put in formaldehyde solution for cell-block analysis.

Diagnostic yield of cell block will be defined as enough histologic tissue core containing pancreatic parenchyma or tumor with dysplastic cells enough for the correct tissue diagnosis. In the presence of malignant tissue in core specimens, it will be calculated the proportion of the area positive for malignancy compared to the total area of the core and then the each needle yield will be defined.

Eligibility Criteria:
Inclusion Criteria:

- solid pancreatic lesion larger than 15 mm

Exclusion Criteria:

* pancreatic cystic lesion
* lesion not detected in EUS
* abnormal coagulation parameters (INR\> 2, platelet count \< 50,000)
Study to Evaluate the Safety and Efficacy of Intravenous Glassia® Treatment in Lung Transplantation

This study evaluates the safety and efficacy of intravenous GLASSIA® treatment in lung transplantation.

There is clinical rationale to advocate the use of AAT(GLASSIA) therapy during episodes of lung inflammation, including acute and chronic rejection. AAT may provide more specifically targeted prevention of pathogenic inflammation, superior to that of general immunosuppressants, with little risk. AAT is the main inhibitor of Neutrophil elastase(NE) in the lower airways and patients with AAT deficiency have low concentrations of the protein in this region of the lung. This explains the proteinase/antiproteinase theory of the development of emphysema in deficient patients in which the amount of elastase released in the lung exceeds the amount of AAT. The net result is persistence of elastase activity leading to lung destruction and the pathological changes of emphysema. Administration of AAT will help to prevent further destruction of the lung architecture and reduce the inflammatory dysregulation that causes pulmonary dysfunction. It is expected that by attacking a specific and previously untreated key component of the pathophysiological cycle of BOS, AAT therapy would decrease the prevalence of BOS in lung transplant recipients and prolong life expectancy of these patients. This will be an open label study in order to ensure safety, in the frame of POC study.

Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated informed consent.
2. Age ≥18 years.
3. Subject is planned to undergo first single or double lung transplant (including heart-lung transplant) as per standard implantation procedure.

Exclusion Criteria:

1. Subject has immunoglobulin A (IgA) deficiency and known anti IgA antibodies.
2. Known history of OR positive serological evidence at the time of screening for hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), Parvovirus B19 (PVB19) or human immunodeficiency virus (HIV) Type 1/2 infection
3. Subjects with a history of severe immediate hypersensitivity reactions, including allergies, anaphylaxis to plasma products or any human proteins of different source.
4. Pregnant or lactating women at entry to study and women of child bearing potential, who are unwilling to agree to continue to use acceptable methods of contraception throughout the study.
5. Presence of psychiatric/ mental disorder or any other medical disorder which might impair the subject's ability to give informed consent or to comply with the requirements of the study protocol.
6. Alcohol abuse or history of alcohol abuse.
7. Illegal drugs.
8. Candidate for organ transplantation other than first lung or heart-lung transplantation
9. Clinically significant bronchial stenosis unresponsive to dilation and/or stenting
10. Participation in another interventional clinical trial within 30 days prior to baseline visit.
11. Inability to attend scheduled clinic visits and/or comply with the study protocol.
12. Any other factor that, in the opinion of the investigator, would prevent the subject from complying with the requirements of the protocol.
Study of a Potential New Treatment for Patients With Toxic Epidermal Necrolysis (TEN)

To determine whether treatment of patients who have toxic epidermal necrolysis with a drug called remicaide increases the number of patients who are alive 30 days laters.

This is a pilot (preliminary) study. Patients with a diagnosis of TEN will be asked to consider participating. The study intervention is a single intravenous dose of remicaide (5 mg/kg). Standard supportive care will be given. The percentage of patients alive at 30 days after treatment with remicaide will be compared to historical controls.

Eligibility Criteria:
Inclusion Criteria:

* Admission to burn unit with a histologic diagnosis of TENs

Exclusion Criteria:

* Pregnancy
* hypersensitivity to remicaide
* history of heart failure
* documented bacteremia
* history of cancer
* inability to consent
A Study in Healthy People to Test How Well Repeated Doses of BI 3032950 Are Tolerated

The main objectives of this trial are to investigate safety, tolerability, pharmacokinetics and pharmacodynamics following multiple rising intravenous doses of BI 3032950 in healthy male subjects and postmenopausal or surgically sterilised female subjects (women not of child bearing potential (WNOCBP)).


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subjects and female subjects not of child bearing potential (women not of child bearing potential (WNOCBP)) - postmenopausal or surgically sterilised female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
2. Age of 18 to 65 years (inclusive)
3. Body mass index (BMI) of 18.5 to 29.9 kg/m\^2 (inclusive)
4. Signed and dated written informed consent in accordance with International conference on harmonisation-good clinical practice (ICH-GCP) and local legislation prior to admission to the trial
5. Male subjects (including male subjects with pregnant partners) who meet any of the criteria listed in the protocol for a highly effective contraception from the first administration of trial medication until the end of study (EoS) visit.
6. Postmenopausal or surgically sterilised female subjects (WNOCBP) who are:

   * Confirmed surgically sterilised (including hysterectomy, bilateral salpingectomy and bilateral oophorectomy), or
   * Postmenopausal, defined as at least 1 year of spontaneous amenorrhea without an alternative medical cause Further inclusion criteria apply.

Exclusion Criteria:

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 100 beats per minute (bpm); in case of documented 'white coat hypertension' the decision for eligibility is left to the investigator
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.
Clinical Observation of Ningmitai Capsule in Treating Chronic Pelvic Pain Syndrome With Erectile Dysfunction

Objective: The purpose of this study was to evaluate the clinical efficacy and safety of Ningmitai capsule alone or in combination with sildenafil compared with sildenafil alone in the treatment of CP/CPPS with erectile dysfunction.

Study Design: A multicenter, prospective, randomized and positive drug-controlled clinical study design was adopted.

Interventions:

① Western medicine group (sildenafil): Sildenafil citrate, 25mg/capsule, once a night, one capsule each time, for 4 weeks.

② Chinese medicine group (Ningmitai capsule): Ningmitai capsule, 0.38 g/capsule, 3 times a day, 4 capsules each time, taken after meals for 4 weeks continuously.

③ Combination group (Ningmitai capsule + sildenafil): Ningmitai capsule, 0.38 g/capsule, 3 times a day, 4 capsules each time, taken after meals; Sildenafil citrate, 25mg/capsule, once a night, one capsule each time, was taken continuously for 4 weeks.

Sample size: 214

Eligibility Criteria:
Inclusion Criteria:

1. Male patients aged 20-50 years;
2. Have a fixed sexual partner and have a normal sexual life;
3. Long-term and repeated pelvic discomfort or pain (NIH-CPSI pain score ≥ 4), or accompanied by lower urinary tract symptoms (micturition score \> 4), lasting more than 3 months;
4. Secondary patients with erectile dysfunction after normal erection or sexual intercourse, and IIEF-5 ≤ 21 points;
5. It accords with the main symptoms of damp-heat stagnation syndrome in traditional Chinese medicine;
6. Volunteer subjects and agree to sign informed consent.

Exclusion Criteria:

1. Those who use any antibiotics, α-receptor blockers, PDE5 inhibitors and androgens within one week;
2. Patients with varicocele or tumors in prostate, bladder and urethra;
3. Have received TURP, TUIP, bladder neck incision, transurethral hyperthermia/radiofrequency ablation/balloon dilatation, open prostatectomy, or any other prostate surgery and treatment, such as cryotherapy or hyperthermia;
4. Patients with severe organic ED, drug-induced and traumatic ED, abnormal development of external genitalia or abnormal sex hormone level;
5. Patients with severe cardiovascular and cerebrovascular diseases, liver, kidney and hematopoietic diseases and psychosis;
6. Those who are known to be allergic to the drugs tested in this study or some of their components
Noninvasive Hemoglobin Repeatability and Reproducibility in a Blood Donation Setting

The primary objective of this clinical investigation is to report on the repeatability and reproducibility of SpHb measurements from Rad-67 devices and DCI Mini sensors used to screen prospective blood donors at a donation center.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Weight at least 110 pounds
* Subjects with the intention of being screened for eligibility to donate blood
* The subject has given written informed consent to participate in the study

Exclusion Criteria:

* Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, infections, abnormalities, etc.
* Subjects unwilling to remove nail polish or acrylic nails
* Subjects with blood cancers such as leukemia
* Subjects with hemoglobin disorders such as sickle-cell anemia and thalassemia or with known history of infectious diseases such as HIV/AIDS, syphilis, hepatitis, etc.
* Subjects with self-disclosed/known pregnancy at the time of enrollment
* Subjects deemed not suitable for the study at the discretion of the investigator
* Subjects unlikely to be able to refrain from excessive motion during data collection. Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.
Assessing the Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Toric Contact Lenses

The purpose of this clinical trial is to assess on-eye performance and overall fit of an investigational multifocal toric contact lens to aid in confirmation of the study lens design.

Subjects will attend 3 study visits with a planned individual duration of participation of up to 10 days.

Eligibility Criteria:
Key Inclusion Criteria:

* Requires ADD (additional power for near vision);
* Currently wears multifocal soft contact lenses in both eyes during the past 3 months;
* Manifest cylinder power between -0.75 diopter (D) and -1.00 D;
* Best Corrected Visual Acuity (BCVA) of logMAR 0.10 (Snellen 20/25) or better in each eye.
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
* Current or history of pathologically dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
* Monovision contact lens wear.
* Other protocol-specified exclusion criteria may apply.
Neuropeptides in the Humane Intra- og Extracerebral Circulation.

The study aim at examining whether Sumatriptan changes the plasma values of the neuropeptides vasoactive intestinal polypeptide (VIP), calcitonin gene-related peptide (CGRP) and pituitary adenylate cyclase activating peptide (PACAP) and the prostanoids 6-keto-PGF1α, and PGE2, PGD2 og PGF2α.

The study is meant to give a better understanding of the basic mechanisms behind migraine, and a better understanding of the effects of sumatriptan on the trigemino vascular system.

The endpoints are changes in the plasma values of the neuropeptides vasoactive intestinal polypeptide (VIP), calcitonin gene-related peptide (CGRP) and pituitary adenylate cyclase activating peptide (PACAP) and the prostanoids 6-keto-PGF1α, and PGE2, PGD2 og PGF2α.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers
* 18-50 years,
* 50-100 kg.
* Fertile women must use birth control.

Exclusion Criteria:

* All primary types of headache
* Daily intake of medicine except birth control
* Pregnancy
* Hypertension
* Hypotension
* other chronic disease
Prevention of Potentially Inappropriate Prescribing in Late Life Using Screening Tool of Older Persons' Potentially Inappropriate Prescriptions (STOPP) and Screening Tool to Alert Doctors to Right Treatment (START) Criteria

Potentially inappropriate prescribing is common in older patients and encompasses overuse, misuse and underuse of medications. Potentially inappropriate prescribing is associated with negative outcomes including adverse drug events and hospitalization.

STOPP (Screening Tool of Older Person's potentially inappropriate Prescriptions) and START (Screening Tool to Alert doctors to Right Treatment) is a new screening tool designed to detect instances of potentially inappropriate medication use and under-prescribing of clinically indicated medications in older patients. The purpose of this study is to determine whether clinical implementation of STOPP/START criteria in hospitalized older patients is effective in improving prescribing quality.


Eligibility Criteria:
Inclusion Criteria:

* All patients aged 65 years and older admitted to the general medical services of Cork University Hospital, Cork, Ireland

Exclusion Criteria:

* Patient admitted to a geriatric medicine service, psychiatry of old age service or clinical pharmacology service, or under review of these services during the previous 12 months
* Critically ill patient (admitted to the intensive care unit)
* Terminally ill patient
* Refusal of patient or hospital physician to participate
* No time for the research physician to enrol the patient within 3 days of admission