cyrilzakka/clinical-trials huggingface dataset:
Preoperative Magnetic Tracking in Breast Surgery in France: French Medical-economic Study.

MAGNETO is a French medico-economic study on preoperative localization in breast cancer surgery. The main objective is to conduct a cost-consequence analysis comparing magnetic clip localization with the use of metallic wires for the preoperative identification of non-palpable breast lesions. The choice of localization method is left to the physician's and center's discretion. The study is non-interventional (with only questionnaires and data collection), prospective, and multicenter, with patient follow-up lasting up to six months after breast surgery.

The MAGNETO study is a non-interventional, prospective, and multicenter study. It includes two cohorts: one using magnetic clip localization and the other using metallic wire localization.

Patients are enrolled by the surgeon during the preoperative consultation validating the conservative surgery with preoperative localization. The choice of cohort is left to the discretion of the center based on their routine practice. Baseline data, including patient and disease characteristics, are collected.

Depending on the assigned cohort, localization is performed either with a magnetic clip or a metallic wire. A mammogram is then performed to assess the correct positioning of the marker and its distance from the target lesion. At this stage, the radiologist completes a Likert scale satisfaction questionnaire.

Breast-conserving surgery is performed according to the hospital's standard practices. On the day of the procedure, the surgeon also completes a Likert scale satisfaction questionnaire.

Patients complete quality of life (EQ-5D-5L) and satisfaction questionnaires at several points throughout the study. Postoperative complications are also recorded.

Eligibility Criteria:
Inclusion Criteria:

* I1. Female aged ≥ 18 years;
* I2. Patient presenting with a unifocal and unilateral lesion of invasive carcinoma or in situ;
* I3. Indication for first breast-conserving treatment with the need for preoperative localization of the lesion, regardless of the associated lymph node procedure;
* I4. Patient affiliated with a health insurance system;
* I5. Non-opposition to the study.

Exclusion Criteria:

* E.1. Psychological, family, or sociological condition that may potentially compromise adherence to the treatment protocol and follow-up;
* E.2. Bilateral surgery required;
* E.3. Patient with metastatic breast cancer;
* E.4. Multifocal or benign lesions;
* E.5. Pregnant or breastfeeding patient;
* E.6. Need for neoadjuvant treatment;
* E.7. Associated breast reduction procedure;
* E.8. Patient under guardianship, curatorship, or deprived of liberty.
"Connected Caesarean Section": Creating a Virtual Link Between Mothers and Their Infants to Improve Maternal Childbirth Experience: A Pilot Trial

One third of mothers rate their childbirth as traumatic. The prevalence of childbirth-related posttraumatic stress disorder (CB-PTSD) is of 4.7% and the prevalence of childbirth-related posttraumatic stress symptoms (CB-PTSS) of 12.3%. Skin-to-skin contact is a protective factor against CB-PTSD. However, during a caesarean section (CS), skin-to-skin contact is not always feasible and mothers and infants are often separated. In those cases, there is no validated and available solution to substitute this unique protective factor. Based on the results observed in studies using virtual reality (VR) and head-mounted displays (HMDs) and studies on childbirth experience, we hypothesize that enabling the mother to have a visual and auditory contact with her baby could improve her childbirth experience whilst she and her baby are separated. To facilitate this connection, we will use a 2D 360° camera filming the baby linked securely to a head-mounted device (HMD) that the mother can wear during the end of the surgery.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 years old or older
* Planned or unplanned CS at ≥ 34 weeks gestation
* Gave birth to a healthy baby according to pediatric evaluation (APGAR score ≥ 7 at 5 minutes)
* Gave oral consent followed by a written confirmation of consent
* Skin-to-skin contact is not possible or was prematurely interrupted
* Speaks French well enough to participate in study assessments
* Eligibility confirmed by an independent physician for the intervention group
* Partner gave oral consent to be filmed for the intervention group.

Exclusion Criteria:

* Has an established intellectual disability or psychotic illness
* Has photosensitive epilepsy
* Caesarean section under general anesthesia
Blind Gastric Tube Placement: Incidence of Malposition Confirmed by Ultrasonography

This is a prospective, single-arm cohort, observational study to determine the incidence of gastric tube malposition during blind insertion by an anesthesia provider.


Eligibility Criteria:
Inclusion Criteria:

* The adult population, ages 18 and greater
* Patients undergoing general anesthesia with an endotracheal tube that will have a gastric tube blindly inserted by an anesthesia provider

Exclusion Criteria:

* Pediatric population (\<18 years)
* Gastric tube inserted under direct visualizing (the use of a Mac or Miller laryngoscope or any video laryngoscope)
* Inability to visualize gastric tube by ultrasound due to body habitus, analogous anatomy, etc
* Pre-anesthesia insitu gastric tube
* Gastric tube inserted by practitioner other than a member of the anesthesia team
Attention and Social Behavior in Children

This study examines the way attention may be linked to temperamental risk for anxiety, social behavior and brain processes. The study aims to see if temperamentally at risk youth display an attention bias towards threat, and if anxiety symptoms can be reduced through attentional bias modification training.


Eligibility Criteria:
Inclusion Criteria:

* 9-12 year olds who do not meet exclusionary criteria (split into groups based on high and low temperamental shyness)

Exclusion Criteria:

* presence or permanent metal orthodontics or implanted metal devices
* severe psychiatric diagnosis
* IQ under 70 as assessed by the WISC
Low Back Study to Compare Traditional Physical Therapy With Combined Therapy Protocol

The most common chronic low back pain conditions are a consequence of disc disease as well as muscular and bony etiologies. The discs degenerate and weaken, bulge and are pushed into the space containing the spinal cord or a nerve root resulting in severe pain. A common treatment is then surgery. Whole-body vibration combined with un-weighting traction and specific manual mobilization plus active therapeutic exercise seems to treat chronic low back pain by non-invasively firing muscles of the lumbar spine. The investigators are seeking to show such therapy reduces the need for surgery and significantly out performs traditional physical as the preferred conservative treatment.

Patients will be placed randomly in the control group and will receive 10 weeks of standard physical therapy or in the study group and receive an equivalent 10 weeks therapy utilizing vibration, unweighting, therapeutic exercise and manual mobilization. The study uses a baseline MRI and x-rays which have shown the justification for surgical intervention and during the course of the protocol will have repeat MRI's and x-rays to determine any statistical change in the lumbar spine resulting in reduction or elimination of pain, improved range of motion, improvements in performance and reduction or elimination for the need for surgical intervention. Anatomical measures will be done comparing pre-treatment versus post-treatment and will include foraminal dimensions,disc height, canal stenosis, lumbosacral angle and facet spacing. Questionnaires will be completed during the course of the treatment and post-treatment at 6 months and one year. The final follow up phone call to the patient will be made following 24 months post initial treatment to determine the current patient status pertaining to low back pain, subsequent treatment, surgery, etc. Final study documentation will occur at that time. Intermediate results at one year will compare the control group vs. the study group for overall result differences.

Eligibility Criteria:
Inclusion Criteria:

* MRI of the lumbar spine showing symptoms and severity to qualify for surgery
* 25 to 65 years of age
* Diagnosis of low back pain for 3-12 months
* Potential surgical candidates but not mandatory

Exclusion Criteria:

* any medical or physical conditions deemed unacceptable by the participants physician or health care provider
* Evidence of progressive or debilitative medical conditions i.e. metastatic cancer, major stroke, crippling arthritis, unstable angina, orthostatic hypotension, hemiplegia, multiple sclerosis or Parkinson's disease.
* Any condition that would preclude the additional burden of a repeat MRI or preclude active involvement in the protocol or physical therapy
* Active use of tobacco products
* Prior back surgery
* Pregnancy
The Risk of Major Bleeding With Novel Anti-platelets: A Comparison of Ticagrelor With Clopidogrel in a Real World Population of 5000 Patients Treated for Acute Coronary Syndrome

A retrospective real world analysis of bleeding events with ticagrelor compared to clopidogrel in ACS patients.

Major bleeding after myocardial infarction portends a poor outcome. A balance is required between potency of platelet inhibition and risk of bleeding. Ticagrelor provides faster and more effective platelet inhibition than Clopidogrel. In the PLATO trial Ticagrelor reduced the incidence of cardiovascular death, myocardial infarction and stroke compared to Clopidogrel after ACS (acute coronary syndrome). Although there was no difference in overall bleeding there was more non-CABG related major bleeding with Ticagrelor. It has since been recommended, in addition to aspirin, in treatment of moderate-high risk ACS by both ESC (European Society of Cardiology) and NICE (National Institute for Clinical Excellence). There has been widespread adoption as first line therapy in UK hospitals. There remains potential concern about bleeding in a "real world" population compromising more high risk patients; particularly more elderly and female, than those in PLATO. The investigators intend to perform a large "real world" comparison of bleeding risk with Ticagrelor compared to Clopidogrel in a UK ACS population. The investigators plan an observational cohort study of patients presenting with ACS at 5 district general hospitals in Merseyside and Cheshire. The investigators will collect data retrospectively on 2500 patients treated with Clopidogrel prior to the guideline change and 2500 treated with Ticagrelor thereafter. The primary end point will be incidence of BARC 3-5 (Bleeding Academic Research Consortium) and PLATO major bleeding.

Eligibility Criteria:
Inclusion Criteria:

1. Patient commenced on clopidogrel for ACS prior to change of ACS guidelines, or tiacgrelor for same indication afterwards.

Exclusion Criteria:

1. Patient already taking the drug in question (clopidogrel or ticagrelor) prior to the ACS event
2. Patients under 18 years of age
3. Patients in whom the drug is stopped during the same hospital admission due to clinical judgement dictating that it is no longer indicated (this does not apply to patients in whom a bleeding event is the precipitant for stopping the drug)
Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer

Proposed immunotherapy with an extended course of Sipuleucel-T treatment may induce a more robust immune response and improve the anti-cancer efficacy of Sipuleucel-T in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC).

This open-label, pilot trial aims to evaluate the feasibility of Sipuleucel-T given in three doses at weeks 0, 2, and 12-14; and to investigate the changes in immune response in mCRPC patients who are getting an extended course of Sipuleucel-T treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Men ≥ 18 years of age
2. Prostate cancer with history of metastasis
3. Candidates for Sipuleucel-T treatment are defined as those with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. Life expectancy of ≥ 6 months

Exclusion Criteria:

1. Previously received Sipuleucel-T (Provenge®)
2. Known malignancies other than prostate cancer likely to require treatment within 6 months following registration
3. A requirement for systemic immunosuppressive therapy (\>10mg Prednisone daily or equivalent)
4. A history of allergic reactions attributed to compounds of similar chemical or biologic composition to Sipuleucel-T or GM-CSF
5. Any infection requiring antibiotic therapy within 1 week prior to registration
Subcutaneous (SC) Darbepoetin Alfa in Subjects With Symptomatic Congestive Heart Failure (CHF) & Anemia

The purpose of this study is to evaluate whether weight-based or fixed starting doses result in comparable hemoglobin increases and treatment effects in patients with heart failure and anemia.


Eligibility Criteria:
Inclusion Criteria: - Symptomatic CHF for at least 3 months - Reduced left ventricular ejection fraction - Stable heart failure medication - Hemoglobin concentration between 9.0 and 12.5 g/dL Exclusion Criteria: - Hypertension - Unstable angina pectoris or recent myocardial infarction - Likely to receive cardiac transplant - Major organ transplant (e.g., lung, liver, heart) or in renal replacement therapy (e.g., dialysis) - Recent or current treatment for malignancy - Systemic hematologic disease - Anemia due to acute or chronic bleeding - Recent Epogen® or darbepoetin alfa therapy - Recent blood transfusion
Creatine Kinase Versus 3D Doppler for Antenatal Diagnosis of Abnormal Adherent Placenta.

Placenta accreta is a potentially life-threatening obstetric condition that requires a multidisciplinary approach to management.Diagnosis of placenta accreta before delivery minimizes potential maternal or neonatal morbidity and mortality. In this study the researchers will evaluate the role and cost effectiveness of biochemical marker as creatine kinase in comparison with 3D Doppler ultrasound in antenatal diagnosis of placenta accreta and its variants in patients with placenta previa totalis.

Abnormal placentation poses a diagnostic and treatment challenge for all providers caring for pregnant women. As one of the leading causes of postpartum hemorrhage, abnormal placentation involves the attachment of placental villi directly to the myometrium with potentially deeper invasion into the uterine wall or surrounding organs. Surgical procedures that disrupt the integrity of uterus, including cesarean section, dilatation and curettage, and myomectomy, have been implicated as key risk factors for placenta accreta(Megier et al., 2000).Prenatal diagnoses of placenta accreta through the use of gray-scale ultrasonography, color Doppler imaging, and magnetic resonance imaging have been reported previously (Chou et al., 1997).

Placenta increta and percreta have rarely been diagnosed antepartum, and ultrasonographic findings may provide the only objective evidence of placenta accreta.A biochemical marker for this condition would therefore be useful (Ophir et al., 1999).It is critical to make the diagnosis before delivery because preoperative planning can significantly decrease blood loss and avoid substantial morbidity associated with placenta accreta (Shih et al., 2009).

Eligibility Criteria:
Inclusion Criteria:

- a- Pregnant lady with history of previous cesarean section or hysterotomy. b- Placenta previa with its lower edge covering the scar of previous cesarean section as diagnosed by 2DU/S.

c- Gestational age ranging from 28 wks - Full term.

Exclusion Criteria:

* Women with one or more of the following conditions contributing to rhabdomyolysis:

  1. Crush injury and prolonged surgery.
  2. Embolism, thrombosis, D.V.T., myocardial or brain infarction.
  3. Drug overdose: Antipsychotics, antidepressants, hypnotics, narcotics, alcohol, halothane,salicylates.
  4. Excessive muscle activity as epileptic fit.
  5. Chronic hypertension \& PIH
  6. Endocrine disorders: hyper-/hypothyroidism, and diabetes mellitus,history of liver disease or renal disease.
Feeding Intolerance in Formula-Fed Infants

This is a non-randomized, single-group, multi-center, two phased study to evaluate formula intolerance.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria for Stage 1:

* Singleton full term birth with birth weight of \> 2500g.
* Infant between 0 and 60 days of age.
* Discontinuation of medications that might affect gastrointestinal (GI) tolerance.
* Infant is exclusively formula-fed a full-lactose, intact cow milk protein-based infant formula (CMF) for less than 7 days prior to enrollment.

Inclusion Criteria for Stage 2:

* Infant was fed according to protocol in Stage 1 of the study.
* Infant was identified as being fussy using the Intolerance Assessment Tool in Stage 1.

Exclusion Criteria:

Exclusion Criteria for Stage 1:

* Chromosomal or major congenital anomalies.
* Suspected or known metabolic or physical diseases affecting infant feeding and/or metabolism.
* Hospitalization, other than for delivery, prior to enrollment.
* Severe uncontrolled eczema, visible bloody stools or milk protein allergy prior to enrollment.
* More than 1 substitution of an infant formula other than full-lactose, intact cow milk formula (CMF) since birth.
* Use of a prokinetic drug within 7 days before enrollment.

Exclusion Criteria for Stage 2:

* Infant's intolerance symptom was caused by another reason, for example known infection/illness, food allergy, or response to vaccination(s).
* Infant has immunization(s) within 3 days of enrollment in Stage 2.
Liposomal Amphotericin B (AmBisome) Pharmacokinetics Given as a Single Intravenous Dose to Obese Patients (ASPEN)

Dosing guidelines for liposomal amphotericin B (AmBisome) in (morbidly) obese patients are not available. Subsequently, the pharmacokinetic profile of AmBisome in this specific patient population is still largely unknown.

To build a valid pharmacokinetic model, obese patients with a BMI ≥ 40 undergoing endoscopic gastric bypass surgery will receive a single dose of 1 mg/kg or 2 mg/kg AmBisome (besides standard anti-bacterial prophylaxis) and a PK-curve will be drawn. These PK-values can then be compared to the pharmacokinetics of a normal-weight group.

* The overall trial design is a prospective, open-label, non-randomized, single-centre, single-dose, multiple dose level trial, (1 mg/kg and 2 mg/kg).
* A total of sixteen patients with a BMI ≥40 kg/m2 undergoing bariatric surgery who receive a pre-surgery dose of AmBisome 1 mg/kg (n=8) or 2 mg/kg (n=8) will be enrolled.
* After enrollment of group 1 (1 mg/kg), an interim analysis on the safety of AmBisome will be performed before proceeding to group 2 (2 mg/kg).
* Infusion time and concentration of AmBisome will be 45 minutes (1 mg/kg group) and 90 minutes (2 mg/kg group)
* A PK curve will be determined after administration of a single, pre-surgery dose of AmBisome at t = 0.5, 0.75 (end of infusion group 1), 1.5 (end of infusion group 2), 2, 4, 6, 8, 10, 12, 24, 36, and 48 and (if feasible) 72 hours post infusion (n=12 samples) for group 1 (1 mg/kg), 8 patients.The PK curve of group 2 (2 mg/kg, 8 patients) will be similar to group 1, except for the t=1.5 hour sampling point, which will be end of infusion due to the infusion time of 90 minutes.
* Patients are considered to have completed the study if at least 9/11 samples of the PK curve up until 48 hours have been collected.
* Patients will be selected by the research team to have a good spread in weight bands.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has a BMI ≥40 kg/m2 and is undergoing bariatric surgery
2. Subject is at least 18 of age on the day of screening.
3. Subject or legal representatives are able and willing to sign the Informed Consent before screening evaluations.

Exclusion Criteria:

1. Documented history of sensitivity to medicinal products or excipients similar to those found in the polyene preparation.
2. History of, or current abuse of drugs, alcohol or solvents (up until a maximum of three months before enrolment).
3. Inability to understand the nature of the trial and the procedures required.
4. Administration of nephrotoxic medication (aminoglycosids, immunosuppressants, antivirals, antineoplastic agents) up until a maximum of one month before enrolment.
A Study of the Effect of Glucagon-like Peptide 1(GLP-1) Receptor Agonist in Combination With Metformin Therapy on Diabetes Remission in Subjects With Newly Diagnosed Type 2 Diabetes Who Are Overweight or Obese

The purpose of this study is to determine the effect of GLP-1 receptor agonist on inducing diabetes remission in newly diagnosed type 2 diabetes who are overweight or obese

Most of type 2 diabetes are characterized by being overweight or obese mainly caused by insulin resistance. GLP-1 receptor agonist has been proved to help to lose weight and improve insulin resistance. In this study, we suppose that GLP-1 receptor agonist has the effect of inducing diabetes remission in newly diagnosed type 2 diabetes who are overweight or obese and has its advantages

Eligibility Criteria:
Inclusion Criteria:

* A signed and dated informed consent form obtained from the subject before any study related procedures take place.
* Age ≥18 years to ≤65 years at Visit 1.
* The subject has a new diagnosis of type 2 diabetes without any treatment.
* HbA1c ≥8.0% to ≤14.0% at Visit 1.
* BMI(Body Mass Index)≥24kg/m2 to ≤40kg/m2 at Visit 1.

Exclusion Criteria:

* The subject has a history of type 1 diabetes or a secondary form of diabetes.
* The subject has received an anti-diabetic drug before the screening visit.
* Treatment with systemic steroids 2 months prior to screening
* Treatment with anti-obesity drug 2 months prior to screening or any other treatment at the time of screening(i.e. surgery etc) leading to unstable body weight.
* The subject has a history of acute or chronic pancreatitis
* Any gastrointestinal diseases or surgeries that induce chronic malabsorption
* Cancer and medical history of cancer(except basal cell skin cancer or squamous cell skin cancer).
* The subject has a history of recurrent severe hypoglycaemia.
* Cardiovascular disease,within the last 6months prior to screening,defined as: stroke;decompensated heart failure New York Heart Association(NYHA) class III or IV;Myocardial infarction;unstable angina pectoris;or coronary bypass graft or angioplasty.
* Uncontrolled treated/untreated severe hypertension (systolic blood pressure ≥180 millimetre(mm) mercury(Hg) and/or diastolic blood pressure ≥100 millimetre(mm) mercury(Hg).
* Impaired liver function,defined as alanine aminotransferase(ALT) or aspartate aminotransferase(AST) ≥2.5 times upper limit of normal.
* Impaired renal function,defined as serum-creatinine ≥125umol/l for males and ≥110umol/l for females.
* Females who are pregnant or breast-feeding, males and females of childbearing potential,who do not agree to prevent conception during the study.
* Known or suspected abuse of alcohol,narcotics or illicit drugs.
Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Pratice (Netherlands)

This prospective cohort study will provide information about: characteristics of Rivaroxaban use in patients who are prescribed Rivaroxaban for the first time compared to patients who are prescribed Acenocoumarol for the first time, the occurrence of intracranial haemorrhage, gastrointestinal and urogenital bleeding, and the occurrence of non-infective liver disease.


Eligibility Criteria:
Inclusion Criteria:

* All male and female patients who have been prescribed for the first time either Rivaroxaban or standard of care from the date of market authorization of rivaroxaban to Dec 31, 2017

Exclusion Criteria:

* Patients who have any record of being dispensed their index drug in the year before index date (i.e. cohort entry), or who qualify for both cohorts on the same day will be excluded