cyrilzakka/clinical-trials huggingface dataset:
Clinical Validation of Molecular Triage in HR-HPV Positive Women

Women accessing the HPV-based screening programme for primary screening, will undergo cervical sampling and clinical data recording. Samples from high-risk HPV positive women (around 2000 expected) will be aliquoted for testing with new HPV molecular test, that will allow full genotyping and viral load quantification.


Eligibility Criteria:
Inclusion Criteria:

* women participating in a cervical cancer screening program using an HPV assay as primary screening test
* positivity to hrHPV;
* written informed consent given.

Exclusion Criteria:

* total hysterectomy;
* diagnosis of CIN2+ in the last two years;
* hrHPV negative or inadequate.
VIBRANT Study of Vurolenatide in Adult Patients With Short Bowel Syndrome.

A Study of Vurolenatide in Adult Patients with Short Bowel Syndrome.

A Phase 2 study of Vurolenatide in adult patients with SBS. Patients were planned to be dosed in four treatment groups with placebo and/or active Vurolenatide. The study is 13 weeks (3 weeks screening, 4 weeks SC study drug administration, and 6 weeks of follow up). Safety and efficacy will be analyzed.

Eligibility Criteria:
Key Inclusion Criteria:

Criteria for patient inclusion in this study are as follows:

1. Male and female adults with SBS secondary to surgical resection of small intestine
2. 18-75 years of age at the time of screening.
3. Female patients must be postmenopausal (at least 2 years prior to dosing) or surgically sterile or agree to use an acceptable form of birth control from screening until 30 days after last dose. If oral contraceptives are used, patients must have been on a stable dose for ≥6 months.
4. Male patients must agree to use an acceptable form of birth control during the study and for 30 days after the last dose. Male patients should not donate sperm for 90 days after last dose.
5. At least 6 months since last surgical bowel resection.
6. Patients may be on Parenteral Support \[PS\] (nutrition and/or fluid and electrolytes for at least some of their nutritional needs).
7. If on PS, stable administration of PS volume for 1 month (±20% vol) prior to enrollment \[stable administration of PS volume confirmed by Medical Monitor\].
8. Able to ingest solid or semi-solid foods and drink.

Key Exclusion Criteria:

Criteria for exclusion from participation in this study are presented below.

1. Pregnancy or lactation
2. Body mass index at screening \<18 or \>30 kg/m2
3. Clinically significant intestinal adhesions and/or chronic abdominal pain that can interfere with the conduct of the study
4. Active Crohn's disease or IBD (as evaluated by standard procedures employed by the investigator/institution). If in remission, must be ≥12 weeks of remission prior to screening
5. Inflammatory bowel disease patients who have NOT been on a stable drug treatment regimen for at least the past 3 months prior to screening
6. Visible blood in the stool within the last 3 months
7. Known heart failure or active coronary disease
8. Alcohol or drug abuse within the last 12 months by history, or a disqualifying positive urine drug test at screening.
9. Inadequate renal function as defined by serum creatinine \<0.7 or \>1.3 mg/dL (in men) and \<0.6 or \>1.1 mg/dL in women.
10. Personal or family history of medullary thyroid cancer.
11. History of pancreatitis
12. Any use of growth hormone, or growth factors such as native GLP-2 or GLP-2 analog (teduglutide) within the last 3 months
13. Use of antibiotics within the last 30 days
14. Patient not capable of understanding or not willing to adhere to the study visit schedules and other protocol requirements
The Laryngoscopic View With C-MAC Videolaryngoscope Miller Blade Lifting the Epiglottis or the Vallecula in Children

In this study, the investigators aim to evaluate the glottic visualization and time to intubation during laryngoscopy performed with the C-MAC VL size 1 Miller blade lifting the epiglottis or placing the tip of the blade on the base of the tongue (vallecula) in children younger than 2 years of age.

Direct laryngoscopy (DL) is the most widely used method to ensure airway safety. In pediatric patients under two years of age, Miller laryngoscope blade is recommended as it removes the long and drooping epiglottis from the eye during laryngoscopy and shows the laryngeal entrance better.

In the classical definition, the tip of the Miller blade is placed behind the epiglottis. However, if the intubator wishes, the Miller blade tip can be placed on the root of the tongue (vallecula) and used as a Macintosh blade.

In the literature search, no study has been found so far comparing C-MAC VL 1 numbered Miller blade with intubation by removing the epiglottis or placing the blade on the vallecula. In this study, the investigators aimed to evaluate the glottic image and intubation time during laryngoscopy performed by lifting the epiglottis with the C-MAC VL No. 1 Miller blade or placing the tip of the blade on the base of the tongue in children under 2 years of age.

Eligibility Criteria:
Inclusion Criteria:

* Younger than 2 years of age
* ASA I and II patients
* Elective surgery under general anesthesia with tracheal intubation

Exclusion Criteria:

* upper respiratory tract infection within the previous 4 weeks
* airway difficulties in the preoperative evaluation
* unstable reactions during intubation
To Assess With Ezefeno Tab. in Patients With Dyslipidemia and T2DM

The goal of this Randomized controlled trials is to assess in the long term efficacy and safety of ezefeno. The primary endpoint are:

* major adverse cardiovascular events within 48 months of the trial duration
* microvascular events within 48 months of the trial duration

A prospective, randomized, open-label, parallel, multicenter, active-drug-controlled clinical trial to assess the long-term efficacy and safety of Combined Therapy with Ezefeno Tab. in patients with dyslipidemia who do not achieve adequate control of Non-HDL-C levels even with Moderate-intensity monotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes diagnosed by American Diabetes Association criteria
* Age ≥ 19 years
* Non-HDL-C ≥100 mg/dL, TG ≥200, \<500 mg/dL on moderate-intensity statins
* with cardiovascular risk factor

Exclusion Criteria:

* Pregnant or breastfeeding women
* Uncontrolled hyperglycemia(more than 12.0% for Subject treated with anti-diabetic treatment.)
* Patient with myopathy and rhabdomyolysis
* AST/ALT more than 3 ULN
* Clinical evidence of genetic disorders such as galactose intolerance, Lapp lactose deficiency, and/or glucose-galactose malabsorption
A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes

This trial is conducted globally. The aim of the trial is to investigate the cardiovascular safety of oral semaglutide in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Male or female diagnosed with type 2 diabetes
* Age at least 50 years at screening and presence of cardiovascular disease, or age at least 60 years at screening and presence of at least one cardiovascular risk factor

Exclusion Criteria:

* Current or previous (within 90 days prior to screening) treatment with any GLP-1 (glucagon-like peptide-1) receptor agonist, DPP-4 (dipeptidyl peptidase-4) inhibitor or pramlintide
* Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC)
* History of pancreatitis (acute or chronic)
* History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
* Subjects presently classified as being in New York Heart Association (NYHA) Class IV heart failure
* Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
* Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 60 days prior to screening
* Chronic or intermittent hemodialysis or peritoneal dialysis or severe renal impairment (corresponding to eGFR (glomerular filtration rate, estimated) below 30 mL/min/1.73 m\^2)
* History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ)
Comparison of qPCR to IHC and FISH for Detection of ALK Fusion Mutations in FFPE Tissue From NSCLC Patients

The anaplastic lymphoma kinase gene(ALK) is mutated approximately 5% of non-small cell lung cancers. Testing for this gene is important because there are drugs known as ALK inhibitors that have been shown to significantly delay the progression of ALK-mutated lung cancers. There are a number of ways to test for the presence of the ALK gene in lung cancer biopsy tissue. One method involves making slides and staining them to detect the ALK protein. This is called immunohistochemistry. Another method called fluorescence in situ hybridization(FISH)is used to detect rearrangements of the ALK gene associated with lung cancer. Although both these tests are widely used to test for ALK gene abnormalities, the techniques may not always find the ALK gene mutation because they are not sensitive enough or not enough cancer cells are present in the lung biopsy.

This study is being performed to determine if a technique called quantitation polymerase chain reaction (qPCR) is as accurate or better at finding the ALK gene mutation in lung cancer biopsy tissue.


Eligibility Criteria:
Inclusion Criteria:

* You have a confirmed diagnosis of non-squamous, non-endocrine non-small cell lung cancer.
* Your cancer biopsy has sufficient cancer cells to be tested for the (Epidermal Growth Factor Receptor (EGFR) mutation, the ALK fusion gene abnormality and the research ALK testing.
* Your lung cancer biopsy is determined not to have a mutation in the EGFR gene.
* You are 19 years old or older.
* You fully understand the study and give informed consent to participate as demonstrated by signing the consent.
Establishing Physiologic Outcomes for Ventricular Unloading on VA ECMO

Aim 1: Prospective, observational analysis of the association between echocardiographic measures of cardiac function and left ventricular unloading on VA ECMO.

Aim 2: Prospective, observational analysis of the association between clinical laboratory biomarkers and left ventricular unloading on VA ECMO.

Mechanical circulatory support (MCS) is increasingly utilized as a means of hemodynamic support among cardiogenic shock (CS) patients refractory to optimal medical management. MCS modalities include using either an intra-aortic balloon pump (IABP), Impella®, or ECMO, each with unique benefit/harm profiles. Among the various MCS devices, extracorporeal membrane oxygenation (ECMO) is described as the highest level of support, capable of providing 5+ liters per minute of oxygenated blood flow but is the most invasive. Despite the benefit of maximal cardiopulmonary support, ECMO increases afterload in a failing heart. Left ventricular (LV) unloading or decompression (using simultaneous IABP or Impella®) has been suggested as potential improvement. Observational studies suggest a benefit with LV unloading during VA ECMO for CS, but the mechanisms underlying the association are poorly understood. Prior to trials, a mechanistic understanding of the effect of different LV unloading strategies on key physiologic abnormalities in CS is needed, as the physiologic effects of LV unloading during VA ECMO for CS remain insufficiently defined.

The objective of this study is to define serial changes in common clinical variables routinely obtained during management of patients in CS. These clinical variables are readily accessible to clinicians, but are not typically collected in a sufficiently granular serial manner to characterize their utility as clinical biomarkers. By obtaining scheduled assessments, repeated in a prospective cohort over the clinical course of CS, the investigators will define the physiologic effects of different LV unloading strategies in cardiogenic shock. We will examine a) echocardiographic measures of ventricular distension, and b) blood biochemical measures of peripheral perfusion.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are 18 years of age or older
* Patients with cardiogenic shock
* Patients with mechanical circulatory support, specifically veno-arterial extracorporeal membrane oxygenation (VA ECMO) inserted peripherally

Exclusion Criteria:

* None
Valproate in Late Life Schizophrenia

The purpose of this research study is to analyze the effectiveness and tolerability of a medication, valproate ( Depakote and Depakote ER), in individuals age 50 years and older who have schizophrenia.

It is known that up to 30% of individuals with schizophrenia continue to have symptoms even when treated with current FDA-approved medications intended to treat their schizophrenia. Anticonvulsant medications such as valproate (Depakote and Depakote ER) are known to be effective for related conditions such as bipolar disorder (manic depressive illness), and are also used by some physicians in clinical settings in combination with antipsychotic medications to treat symptoms of schizophrenia. Currently Depakote and Depakote ER are approved by the FDA to treat bipolar disorder and to treat seizure disorder. This study will test to see if Depakote and Depakote ER may improve symptoms of schizophrenia as well when added to antipsychotic medications.

Eligibility Criteria:
Inclusion Criteria:

* Must have a diagnosis of schizophrenia as confirmed by the MINI
* Must be on antipsychotic medication
* Must be age 50 year or older
* Must be capable of providing written informed consent for study participation. In situations where individuals have guardians of person, guardian and subject must both provide written consent; and
* Must live in the Northeast Ohio area.

Exclusion Criteria:

* A primary psychiatric DSM Axis I diagnosis other than schizophrenia
* Actively abusing substances; or
* Medically unstable.
Placental Cord Drainage After Vaginal Delivery

Placental Cord Drainage after Vaginal Delivery A randomized clinical trial


Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy.
* Pregnancy with vertex presentation.
* Gestational age37 up to 42 weeks
* Patient expected to have spontaneous vaginal delivery.
* Maternal age 18 years old or more.

Exclusion Criteria:

* Previous history of Postpartum hemorrhage.
* Antepartum hemorrhage
* Multiple pregnancies
* Instrumental deliveries
* Coagulation disorders
* Over distended uterus (hydramnios, large fetus).
* Patient with extensive extended vaginal or cervical tear.
* Rupture uterus.
* Secondary arrest of cervical dilatation.
* Persistent occipito-posterior.
* Deep transverse arrest of fetal head.
Scleral Lens Fitting Using Wide-Field OCT

The purpose of this study is to see if OCT technology can optimize scleral contact lens fittings. Subjects with keratoconus, post-penetrating keratoplasty (PK), post-LASIK ectasia, post-radial keratotomy (RK), or a variety of anterior surface disorders requiring scleral lens fittings will be considered for enrollment. For each study eye, a clinically-selected scleral lens fit will be compared against an OCT-selected lens fit. The quality of each lens fit will be determined by flourescein exam at the slit lamp. Apical clearance, limbal clearance, conjunctival compression, and lens edge lift will be assessed. A lens that satisfies all four criteria will be considered satisfactory.


Eligibility Criteria:
Inclusion Criteria:

* Eyes requiring fit for scleral lenses for KCN, post-PK, post-RK, post-LASIK ectasia, or various anterior surface disorders

Exclusion Criteria:

* Inability to maintain stable fixation for OCT imaging
* Inability to commit to required visits to complete the study
* Eyes with concurrent retinal diseases, glaucoma, or other eye conditions that may limit visual outcome
The Brain Processes Underlying Speech Motor Learning and Speech Production

The aim of this research is to develop protocols that selectively target and improve speech-motor learning processes. Participants will be asked to name pictures, read words/sentences, and listen to sounds while their speech signals will be collected during the study.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* native speaker of American English
* normal (age-appropriate) binaural pure-tone hearing threshold
* not taking medications affecting sensorimotor functioning
* no current or history of communication, neurological, or psychological disorders

Exclusion Criteria:
A Comparative Study of Intrathecal Dexmedetomidine and Fentanyl As Additives to Bupivacaine in Pott's Fracture

The aim of this study is to compare the addition of intrathecal dexmedetomidine or fentanyl as adjuvants to hyperbaric bupivacaine in the onset and duration of sensory and motor block, and postoperative analgesia.

The aim of this study is to compare the addition of intrathecal dexmedetomidine or fentanyl as adjuvants to hyperbaric bupivacaine in the onset and duration of sensory and motor block, and postoperative analgesia. All patients will be assessed preoperatively by careful history taking, full physical examination, and laboratory evaluation. An informed written consent will be taken from every patient just before the surgery. On arrival to the operating room, baseline parameters such as ECG, mean arterial blood pressure, heart rate, and oxygen saturation will be recorded. Intravenous line will be inserted and IV Ringer's solution will be started, 500ml bolus will be given as a preload over 20 min before performing spinal anesthesia and maintenance volume of 10ml\\kg.

For each group, patients will be put in sitting position, lumbar puncture will be performed under complete aseptic precautions, local anesthesia will be administered by infiltration of the skin and subcutaneous tissues with 3-5 ml lidocaine 1% at L3-L4 and A 25-G needle will be used.

* Group 1: (Control group) (20 cases): patients will receive 3 ml (15mg) of 0.5% hyperbaric bupivacaine+0.5 ml of normal saline intrathecally.
* Group 2: (Fentanyl group) (20 cases): patients will receive 3 ml (15 mg) of 0.5% hyperbaric bupivacaine+0.5 ml (25μg) of fentanyl intrathecally.
* Group 3: (Dexmedetomidine group) (20 cases): patients will receive 3 ml (15 mg) of 0.5% hyperbaric bupivacaine+0.5 ml (5μg) of diluted dexmedetomidine intrathecally.

Eligibility Criteria:
Inclusion Criteria:

* • ASA I or ASA II patients Scheduled for pott's, of either sex.

  * Age 21-55 years.
  * Height 160 to 190 cm.
  * BMI ≤40.
  * Procedure duration ≤ 90 minutes

Exclusion Criteria:

* • Patients with known neurologic and psychiatric illness.

  * Contraindications for spinal anesthesia as patient refusal, bleeding or coagulation test abnormalities, local skin infection at spinal lumbar region, raised intracranial pressure and hypovolemia.
  * Spine abnormalities.
  * Systemic disorders like hematological, respiratory, cardiac, renal or hepatic insufficiency.
  * Allergy to any of the drugs used in the study.
  * Women with pregnancy and lactation
Epigallocatechingallate (EGCG) in Cardiac AL Amyloidosis

In a proportion of patients with AL amyloidosis there is no improvement of cardiac function despite hematologic response to treatment. The aim of the study is to assess whether treatment with EGCG increases the rate of cardiac response in patients with AL amyloidosis who completed chemotherapy.

This will be a phase II open-label randomized trial. Patients with AL amyloidosis and cardiac involvement who have achieved at least partial hematologic response after chemotherapy will be randomized to receive standard supportive therapy (SST) or SST plus Epigallocatechin gallate (EGCG). After giving written informed consent, the patients will be evaluated for eligibility. Briefly, the subjects with a biopsy-proven diagnosis of AL amyloidosis who achieved at least partial response after chemotherapy, who are not planned to receive further chemotherapy and who have significant cardiac dysfunction will be considered eligible. The patients will be stratified according to the quality of hematologic response and to the severity of cardiac involvement. Following stratification, the patients will be randomized to receive SST or SST plus EGCG. The study comprises 3 periods: screening (including stratification and randomization), treatment (with evaluations of response every 2 months) followed by the end-of-treatment evaluation and follow-up. Therapy will continue for up to 1 year. After treatment patients will be followed for 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AL amyloidosis.
* Age ≥18 years.
* The patients must have been treated for AL amyloidosis attaining hematologic response.
* Evidence of cardiac involvement at echocardiography (mean left ventricular wall thickness \>12 mm in the absence of other causes).
* NT-proBNP ≥650 ng/L

Exclusion Criteria:

* Non-AL (e.g. familial, senile) amyloidosis.
* Concomitant non-amyloid related clinically significant cardiac diseases.
* Need of further chemotherapy for AL amyloidosis.
* Estimated glomerular filtration rate (eGFR) \<30 mL/min per 1.73 m2.
* Uncontrolled infection.
* Inability to give informed consent.
* Previous or ongoing psychiatric illness (excluding reactive depression).
* Pregnant or nursing women.
Evaluate the Effects of Dapagliflozin in Patients With Type 2 Diabetes

This study will make it possible to better understand the mechanisms responsible for the increase in bad cholesterol levels observed in patients with type 2 diabetes treated with Dapagliflozin, an antidiabetic treatment made by Astrazeneca.

The information will:

* reveal what is not working properly
* make it possible to choose the most appropriate treatments against cholesterol to compensate for this impaired functioning

This biomedical research will take place at the University Hospitals of DIJON and NANTES.

* 28 patients will take part: 20 patients will be given Dapagliflozin and 8 patients will be given the placebo.
* The study treatment will be randomised: patients will be given either Dapagliflozin or the placebo. The treatment duration is 6 months.
* Moreover, during the inclusion visit and at the end of the study (6 months after the start of treatment), a kinetics study, to follow the production and elimination of cholesterol, will be conducted. This will involve administering amino acids that have been specifically synthesised for this purpose.
* Participation in the study will last 6 months and include 4 protocol visits.


Eligibility Criteria:
Inclusion Criteria:

* persons who have provided written consent
* type 2 diabetes treated with OAD (metformin and/or sulfonylurea and/or glinides and/or acarbose and/or DPPIV inhibitors)
* Stable treatment for 3 months
* HbA1c between 7.5% and 10%
* Age between 30 and 65 years
* BMI between 25 and 35 kg/m²
* Triglycerides \< 300 mg/dl
* Half of the patients being treated with statins
* eGFR \> 75 ml/min/1.73 m² at inclusion

Exclusion Criteria:

* persons without national health insurance cover
* patients treated with Insulin or a GLP-1 agonist
* Patients under guardianship
* patients treated with lipid-lowering drugs (except statins for 50% of patients)
* kidney failure
* liver failure or abnormal liver function ASAT or ALAT \>3 x upper limit of normal
* total bilirubin \>2mg/dl
* intestinal disease
* serological evidence of an active liver infection (surface antigen of hepatitis B, hepatitis C antibodies, hepatitis B IgM antibodies)
* Pregnancy, breastfeeding
* hypersensitivity to the active substance or to excipients
* patients with volume depletion, for example due to an acute disease (gastro-intestinal disease)
* patients treated with loop diuretics or thiazides