cyrilzakka/clinical-trials huggingface dataset:
Ultrasound-Guided Landmark and Epidural Site Pain

Historically, women who have chronic back pain after pregnancy have attributed the cause to the epidural procedure. While many studies have shown no greater incidence of generalized post-partum back pain in those who received an epidural, no studies have measured localized pressure sensitivity at the epidural insertion site. Short-term pressure sensitivity might limit patient's mobility and activities in the post-partum period. Understanding the factors that increase insertion site pressure sensitivity will allow the investigators to modify epidural placement technique in order to minimize this effect.

Few studies have examined how epidural placement changes localized sensation at the epidural insertion site. This study will be the first study to quantitatively measure sensation at the epidural insertion site. The investigator will assess localized pressure sensitivity with an algometer. An algometer is a hand-held device commonly used by neurologist to detect sensory deficits and measures the pressure sensitivity threshold in a 1-cm diameter circular area. Ultrasound (US) pre-procedural examination provides more accurate landmarks for the placement of epidural catheters. The investigator will determine if an US examination prior to epidural placement reduces localized pressure sensitivity. The investigator will also determine if there are correlations between the participants characteristics and/or comorbidities and increased pressure sensitivity at the insertion site.

Eligibility Criteria:
Inclusion Criteria:

* pregnant with term (37 - 41 weeks) singleton gestation
* active labor
* history of normal pregnancy
* request an epidural
* age between 18 - 35 years old
* able to understand the protocol and provide voluntary, written, informed consent.

Exclusion Criteria:

* history of spinal surgery
* scoliosis
* epidural or spinal placement within the last 5 days
* neuropathic pain disorders
* chronic opioid use
* Texas Department of Criminal Justice patient
* placental percreta
* placental increta
* placenta accreta
* preeclampsia
* eclampsia
Atrial Fibrillation and Other Cardiac Arrhythmias and Diseases After Radiotherapy for Breast Cancer : Watch Your HeaRT

The goal of this interventional study is to evaluate the risk of atrial fibrillation (AF) and other cardiac arrhythmias and diseases in breast cancer patients treated with radiation therapy (RT).

In addition to regular follow-up of patients by the radiation oncologist for 5 years, cardiovascular screening at the end of follow-up, combining the use of a connected watch and a cardiological check-up, could make it possible to identify precisely the types and frequencies of these sometimes asymptomatic, and probably underestimated, cardiac diseases.

The main questions it aims to answer are:

* To assess the incidence of AF and other cardiac arrhythmias and diseases occurring within 5 years after RT
* To evaluate absorbed doses in the heart and cardiac substructures (chambers, conduction nodes, coronaries, pulmonary veins) based on auto-segmentation models developped with deep learning algorithms
* To investigate whether the risk of AF and other cardiac arrhythmias and diseases is associated with cardiac irradiation characterized by these absorbed doses (dose-response relationship)

Participants will be included between 2023 and 2025, 5 years after their RT:

* Retrospective data collection will be based on a medical questionnaire designed to identify cardiac pathologies present prior to RT and those having occured in the past, between RT and 5 years post-RT.
* Cross-sectional data collection will be based on screening for cardiac pathologies using a connected watch worn for 1 month (silent AF screening) and a cardiology consultation (including ECG and echocardiography) to identify cardiac pathologies at 5 years post-RT possibly not identified in the retrospective data collection.


Eligibility Criteria:
Inclusion Criteria:

* Women treated surgically for primary cancer of the left or right breast and for whom adjuvant treatment is RT with irradiation of the breast or chest wall and possibly irradiation of lymph node chains,
* Adjuvant radiotherapy performed at Clinique Pasteur between 2018 and 2020,
* 5-year post-RT follow-up radiation oncologist consultation performed at Clinique Pasteur
* Age ≥ 65 years at the time of the 5-year post-RT follow-up consultation
* Own a smartphone and able to understand and use digital tools alone and/or with the help of a caregiver ;
* Patient having consented to connected follow-up,
* Be affiliated to a social security scheme or equivalent
* Be willing to participate in the study and have signed the consent form

Exclusion Criteria:

* History of cancer before breast cancer RT
* Recurrence of breast cancer or other cancer treated after breast cancer RT
* History of atrial fibrillation prior to breast cancer RT
Safety and Pharmacokinetic Characteristics of DP-R206(Vitamin D3) in Healthy Adult Volunteers

The purpose of this study is to compare the pharmacokinetic characteristics of DP-R206 (150mg Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd) and Vitamin D3 (24,000 IU Vitamin D3 , qd) after oral administration in healthy adult volunteers.

The number of patient is thirty-six. Patients were randomly assigned either a Vitamin D3 tablet(24,000 IU Vitamin D3, qd) first, DP-R206(150mg Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd) Second or DP-R206(150mg Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd) first, Vitamin D3 tablet(24,000 IU Vitamin D3 , qd) second.

Eligibility Criteria:
Inclusion Criteria:

* 20 to 55 years of healthy volunteers

Exclusion Criteria:

* Hypersensitivity Reaction about Ibandronate or other drugs(aspirin, antibiotics)
Oxytocin and Tibolone Adjuncts in Treatment Resistant Depression - A Pilot Study

The purpose of this study is to determine whether an oxytocin ad-on, or oxytocin and tibolone ad-on can induce a response to antidepressants in patients with treatment resistant depression.

We are examining the efficacy and safety of oxytocin or oxytocin and tibolone with an antidepressant (SSRIs) in treatment resistant depression in a double-blind randomized clinical trial.

A secondary objective is the evaluation of neurobiological factors contributing to drug efficacy in treatment resistant depression.

Eligibility Criteria:
Inclusion Criteria:

* Women
* 18-45 years
* Current DSM-IV diagnosis of Major Depression
* Comorbid anxiety disorders secondary to depression will be included
* Past history of at least 2 failed treatment responses (including SSRIs) at the highest tolerated dose for at least 4-6 weeks
* A MADRS score \>20 at randomization
* Women on a stable dose of an SSRI (sertraline, citalopram, escitalopram, paroxetine, fluoxetine or fluvoxamine) for at least 4-6 weeks.
* A negative pregnancy test at screening
* A clinically acceptable Pap smear within the past 2 years
* Must be able to use intranasal spray and swallow tablets

Patients may take up to 2 sleep medications permitted at a dose considered reasonable by the investigating team. Limited adjustments in sleep medication are acceptable. Patients will be asked to notify the researchers of any changes to their sleep medication.

Exclusion Criteria:

* Any previous history of adverse side-effects to escitalopram (or other SSRI)
* Use of oral contraceptives (or any hormonal method of contraception) for the duration of the study
* DSM-IV defined substance dependence, history of bipolar disorder, schizoaffective disorder or schizophrenia
* Significant unstable medical illness including epilepsy, diabetes or cardiac related, renal or liver disease, hormone dependent cancer or pregnancy
* A BMI\<18 or \> 34kg/m2
* Planning for pregnancy
* Renal disease, history of cerebrovascular disease, thrombo-embolic disorders, myocardial infarction or angina at any time before study entry or thrombo-phlebitis within the last 5 years, or any other major illness that has occurred within the last 6 months.
* An undiagnosed genital bleeding
* Moderate to severe acne or hirsutism, have used antiandrogen therapy for acne or hirsutism in the preceding 5 years, have androgenic alopecia ( will exclude women with clinically meaningful androgen excess)
* Active malignancy, or treatment for malignancy in the preceding 6 months (excluding non-melanotic skin cancer)
* Alcohol consumption in excess of 3 standard drinks per day
* Lactose intolerance
* An abnormal thyroid stimulating hormone (TSH) value at screening confirmed by a Free T4 outside the normal laboratory range (patients with an abnormal TSH, normal Free T4 and no clinical signs or symptoms of thyroid disease, with or without replacement treatment, may be admitted to the study).
* A history of allergic reactions to androgens (oral or patch)
* Chronic medications: aspirin and warfarin
Comparison of Outcomes With Stapler Versus Hand-Sewn Closure After Minimally Invasive Distal Pancreatectomy

The incidence of postoperative pancreatic fistula (POPF) after Distal pancreatectomy (DP) remains high. Of the available mitigation strategies, high-quality closure of the pancreatic stump is fundamental.

Researchers failed to find a decrease in the incidence of POPF after stapler closure of the pancreatic stump compared with that related to hand-sewn suture in DP. Minimally invasive DP (MDP) is becoming the first choice for patients and surgeons, few studies have evaluated whether stapler closure is superior to hand-sewn suture for stump closure in MDP.

Therefore, this retrospective study was aimed at evaluating the effect of stapler versus hand-sewn closure on the incidence of POPF after MDP.


Eligibility Criteria:
Inclusion Criteria:

* Underwent elective minimally invasive pancreatic body and tail resection with or without splenectomy

Exclusion Criteria:

* Incomplete medical records
* History of previous pancreatic operations
* Emergent operation
* Conversion to open pancreatectomy
* Receipt of wedge resection or other procedures
Comparison of Three Techniques for Analgesia After Abdominoplasty

This study was conducted to demonstrate post-abdominoplasty analgesic duration consequent to three different surgically infiltrated LA techniques; bilateral TAPB, bilateral RSB and subcutaneous infiltration using the same volume of 0.25% bupivacaine (40 ml). Pain score, total analgesic rescue requests and the total amount of systemic rescue analgesia used in the first postoperative day in addition to any detected postoperative complications were also recorded.


Eligibility Criteria:
Inclusion Criteria:

* all patients listed for abdominoplasty

Exclusion Criteria:

* allergy to bupivacaine
The Chinese Pulmonary Lymphoepithelioma-like Carcinoma Collaboration Study

This retrospective case-control study aims to investigate the genetic mechanisms of primary Pulmonary Lymphoepithelioma-like Carcinoma, identify genetic susceptibility loci associated with its onset, and explore potential pathogenic genes, providing new insights for its etiological research.

Pulmonary lymphoepithelioma-like carcinoma (pLELC) is a rare non-small cell lung cancer (NSCLC) that histologically resembles nasopharyngeal carcinoma (NPC) and predominantly affects the Asian population. Epstein-Barr virus (EBV) infection is a recognized pathogenic factor, and the regional prevalence of pLELC suggests that genetic susceptibility also plays an important role. However, no genetic studies on pLELC have been conducted, leaving its genetic etiology poorly understood. In this study, genotyping for all the subjects was performed by using Illumina Infinium Global Screening Array. Genome-wide association followed by meta-analysis was performed for pLELC cases and healthy controls. The primary objective of this study is to discover susceptibility genes that explain the genetic mechanisms of pLELC.

Eligibility Criteria:
Case:

Inclusion criteria:

The subject is pathologically diagnosed with primary pulmonary lymphoepithelioma-like carcinoma.

Exclusion criteria:

The subject is diagnosed with metastatic nasopharyngeal carcinoma; The subject has heavy cardiovascular, liver, or kidney disease.

Controls:

Inclusion criteria:

The subject is in good physical condition and has a stable level of consciousness;

Exclusion criteria:

The subject has prevalent cancer; The subject has heavy cardiovascular, liver, or kidney disease.
Long-term Safety Study of Alogliptin Used in Combination With Thiazolidine in Participants With Type 2 Diabetes in Japan

The purpose of this study was to evaluate the long-term safety and efficacy of alogliptin and Thiazolidine administered once daily (QD) for 40 consecutive weeks in participants who completed a phase 2/3 Thiazolidine add on study.

Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.

Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes.

To evaluate the long-term safety and efficacy of alogliptin, participants in the present study were enrolled from a core phase 2/3 thiazolidine add on study (SYR-322/CCT-004; NCT01318070).

Eligibility Criteria:
Inclusion Criteria:

1. Had completed the core phase 2/3 thiazolidine add on study.
2. The subject was capable of understanding and complying with protocol requirements.
3. Signed a written, informed consent form prior to the initiation of any study procedure.

Exclusion Criteria:

1. With clinical manifestation of hepatic impairment (e.g., an AST or ALT value of 2.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 thiazolidine add on study).
2. With clinical manifestation of renal impairment (e.g., a creatinine value of 2 mg/dL or more at Week 8 of the core phase 2/3 thiazolidine add on study).
3. With a history or symptoms of cardiac failure.
Effect of F2695 on Functional Recovery After Ischemic Stroke

The purpose of the study is to assess the efficacy of a new serotonin-norepinephrine reuptake inhibitor (SNRI) nin functional recovery after ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient, 18 to 80 years of age
* Confirmed acute ischemic stroke within the past 2 - 10 days
* Unilateral motor deficit,
* National Institutes of Health stroke scale (NIHSS) motor score \>= 5
* Modified Rankin Scale (mRS) of 4 or 5
* Able and willing to comply with the site rehabilitation program requirements

Exclusion Criteria:

* Aphasia
* Severe post-stroke condition
* Active depressive episode
* Intra-cerebral hemorrhage
* Use of anti-depressant drugs
* Cardiac rhythm disorder
* Uncontrolled arterial hypertension
* Other severe acute or chronic medical or psychiatric condition.
Association of Near Infrared Spectroscopy With Interstage Outcomes

The purpose of this study is to assess the utility of renal near infrared spectroscopy in the outpatient setting during the interstage period. The primary aim will be to determine the correlation between oxygen extraction ratio ((arterial pulse oximetry - renal near infrared spectroscopy value)/arterial pulse oximetry value) with need for inpatient admission or intervention. Secondary aims will be to determine the correlation of the oxygen extraction ratio with weight gain, neurodevelopment, unexpected admissions, systemic ventricular strain by echocardiography, and Glenn hospitalization admission characteristics.

As above

Eligibility Criteria:
Inclusion Criteria:

* Infants under 6 months of age
* Infants with single ventricle heart disease and parallel circulation
* Infants who are awaiting the Glenn operation
* Infants who are outpatient

Exclusion Criteria:

* Infants over 6 months of age
* Inpatients
* Infants with history of skin injury from the near infrared spectroscopy sensor inpatient
* Infants with ongoing hyperbilirubinemia
The Glucosamine-study: The Effect of Glucosamine in Treatment of Chronic Low Back Pain

Low back pain (LBP) is the most frequent cause of sick leave and disability pension, and degenerative and osteoarthritic (OA) changes is a significant cause of pain and disability. Some indications exist for symptomatic and possible cartilage-structurmodifying effect on knee- and hip-osteoarthritis with glucosamine sulphate (GS). The OA process in the lumbar spine is most likely to OA processes in knees and hips, hence GS could have comparable symptomatic and structural effect on lumbar OA.

Study hypothesis: No difference in treatment effect exists between oral intake of GS- or placebo-capsules for patients' with chronic low back pain measured with Roland Morris Disability Questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Low back pain for more than 6 months
* Patient older than 25 years old
* MRI findings comparable with lumbar degenerative/osteoarthritic changes.

Exclusion Criteria:

* Spinal stenosis with neurological deficits
* Spinal prolapse with neurological deficits
* Rheumatoid arthritis, psoriatic arthritis,
* Old lumbar fractures
* Chronic pain syndromes (e.g. fibromyalgia)
* Psychosocial status not suitable for participation
* Pregnancy
* Breastfeeding
* Allergic to shellfish
Hybrid Closure of Congenital Heart Disease

Ventricular septal defect (VSD) is one of the most common pediatric congenital malformations. In recent years, in view of the rapid rise of transthoracic minimally invasive hybrid closure for pediatric VSD in the clinical practice, precision assessment of perioperative its effectiveness and safety has already become an important issue that must be solved. On the basis of echocardiography, integrating with characteristics associated critical care, the investigators focus on precision assessment of perioperative effectiveness and safety of transthoracic hybrid closure for pediatric VSD, compared with conventional surgical sternotomy repair with cardiopulmonary bypass (CPB).


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of perimembranous ventricular septal defect, muscular ventricular septal defect, doubly committed subarterial VSD by transesophageal echocardiogram (TEE) with VSD size 5-12mm;
* no significant aortic insufficiency or aortic valve prolapse.

Exclusion Criteria:

* confirmed pulmonary hypertension (systolic pulmonary arterial pressure \>75mmHg or pulmonary vascular resistance \>8.0 Wood U/m2);
* more than mild degree of aortic regurgitation and obvious aortic valve prolapse;
* preoperative congestive heart failure;
* other coexisting cardiac anomalies;
* infective endocarditis.
Prospective Observational Association Between SLCO1B1 Gene Polymorphism and the Anti-factor Xa Activity of Edoxaban in Patients With Moderate to Severe Renal Insufficiency

1. To provide reference for clinical rational use of edoxaban;
2. Optimize the individualized dosing regimen of edoxaban.

In this study, patients with moderate and severe renal insufficiency receiving edoxaban were selected as research objects. The potential safety of edoxaban in patients with different genotypes was evaluated by detecting the anti-XA factor activity and SLCO1B1 genotyping, so as to optimize the individualized administration regimen of edoxaban.

Eligibility Criteria:
Inclusion Criteria:

* Creatinine clearance of 15-50ml/min was calculated according to the Cockcroft-Gault formula
* Patients who received edoxaban 30mg once daily for more than 5 days for non-valvular atrial fibrillation (CHADS2VAS2 score ≥2) and deep vein thrombosis prevention or treatment
* Patients voluntarily participate and sign informed consent

Exclusion Criteria:

* Age \< 18 years old
* Moderate/severe mitral stenosis combined with valvular heart disease, mechanical valve replacement, or rheumatic heart disease
* The patient had used a combination of cyclosporine, erythromycin or ketoconazole or other P-glycoprotein inhibitors within 30 days prior to use or inclusion; Patients were using or had used amiodarone or dronedarone within 30 days prior to inclusion
Rheopheresis Mechanism in Hemodialysis Patients With PAD

Peripheral arterial disease (PAD) is common in chronic hemodialysis patients (HDC) with a prevalence of 30% according to the DOPPS study.

The combination of PAD and chronic kidney disease (CKD) stage 5 is a risk factor for major amputation (24.5%) with a mortality rate of 55% at 2 years.

Ischemia occurring during PAD is the result of impaired microcirculation, with insufficient blood flow to maintain tissue perfusion and viability.

It is responsible for painful skin wounds whose healing is poor, with a significant risk of infection.

In patients with chronic renal failure, it is linked to both:

* local phenomena (atherosclerosis, calcification)
* changes in blood viscosity (elevated hematocrit and inflammatory proteins, especially fibrinogen)
* a neovascularization defect (uremic toxins, in particular indoxyl sulphate). If revascularization is not possible, amputation remains the only possible treatment to relieve pain and limit the risk of infection.

Rheopheresis is an apheresis technique that allows the depletion of high molecular weight serum proteins.

This would reduce blood viscosity and red blood cell (RBC) aggregation, thereby improving microvascular perfusion, with the aim of reducing pain, improving healing and limiting the risk of amputation.

Several studies have investigated the efficacy of rheopheresis in PAD in HDC, but the level of evidence remains low.

The main objective of our study is to evaluate the impact of rheopheresis on blood (main objective) and plasma viscosity, skin microcirculation and blood coagulation (Fibrinography, Thrombin Generation).

No study has evaluated the direct effect of rheopheresis on these different parameters.

However, a better understanding of these mechanisms would make it possible both to optimize the effectiveness of the technique, to limit its potential side effects and the cost of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or more and included in the RHEOPAD protocol (2019-A01513-54)
* ESRD treated by hemodialysis or hemodiafiltration
* PAD-LTI with tissue loss and/or wounds (ulcers or gangrene) with at least one of the following criterion, subject to the feasibility of the measures: arterial pressure assessment at the ankle \<70 mmHg, or toe pressure 30 mm Hg, or transcutaneous oximetry measurements \< 40 mm Hg
* Interventional or surgical revascularization either not technically possible or no necessary
* Medical insurance
* Signed informed consent

Exclusion Criteria:

* - Uncontrolled infection despite well-conducted antibiotic therapy
* Life expectancy \< 1 year
* Severe cognitive or psychiatric disorders
* Pregnant woman, parturient, nursing mother
* Patients unable to give an informed consent or unwilling to participate in the study
Controlled Study of MK-0431/ONO-5435 in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to determine the safety and efficacy of MK-0431/ONO-5435 in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and metformin as monotherapy


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes mellitus on diet/exercise therapy and metformin as monotherapy

Exclusion Criteria:

* Patients with type 1 diabetes mellitus