cyrilzakka/clinical-trials huggingface dataset:
Retrospective Study of Incidence and Etiology of Reoperation After Primary Augmentation With Natrelle® Breast Implants

Retrospective multi-center, post-marketing study to evaluate the incidence and etiology of reoperations with Allergan Natrelle® Breast Implants in primary augmentation (RANBI)


Eligibility Criteria:
Inclusion Criteria:

* Primary breast augmentation (either bilateral or unilateral) operated on by the investigating surgeon with an infra-mammary approach 410 cohesive BIOCELL™ textured device (Truform 2 \& 3 only) has been implanted
* Primary breast augmentation 3 to 10 years prior to data collection
* Submuscular/dual plane or subglandular implant placement

Exclusion Criteria:

* Breast augmentation for Poland Syndrome or amastia
* Breast reconstruction following mastectomy
* Revision or secondary breast reconstruction
* Non 410 device at initial breast augmentation
* Women subsequently diagnosed with fibrocystic disease considered to be pre-malignant
* Procedures of the breast not related to the primary breast augmentation (e.g. excision of skin lesions)
* Axillary or peri-areolar approach
* Glandular mastopexy augmentation (skin excision only)
A Pilot Study of Mindfulness Intervention to the Timing of Labor Admission, Uncertainty and Anxiety

The goal of this quasi-experienmental study is to investigate the effectiveness of mindfulness-based intervention in the level of uncertainty and anxiety, and determintation towards hospital admission among pregnant women. The main questions : • Do pregnant women in intervention group reduce anxiety and uncertainty? • Do pregnant women in intervention group increase self-determintation ability towards hospital admission? Women in the intervention group participated 4 weeks mindfulness-based intervention online courses, Researchers have seen effectiveness of mindfulness-based intervention in the level of uncertainty, anxiety, and determintation towards hospital admission among pregnant women.

The aim of this study is to investigate the effectiness of mindfulness-based intervention in the level of uncertainty and anxiety, and determination towards hospital admission among pregnant women. This study is a quasi-experimental design and convenient sampling to recruit primipara women in the distrct hospital. A total of 31 participants were enrolled, eleven participatns were assigned to the experimental group, and twenty participants were in the control group. The measurements were demographic characteristics andobstetric data, FFMQ,VAS of uncertainty and anxiety, and ACS.

Eligibility Criteria:
Inclusion Criteria:

1. At least 20 years old.
2. Single primiparous women with gestation over 28 weeks.
3. Clear consciousness, ability to speak, write and read Chinese, able to write questionnaires by themselves.
4. Those who are expected to have a vaginal delivery.
5. Agree to participate in the researcher after the research description.

Exclusion Criteria:

1. People with mental health problems, such as: depression, mental illness, etc.
2. The woman has pregnancy complications or the fetus has any complications.
3. Arrange for labor induction.
4. Those who have meditated or attended mindfulness courses.
Decitabine+Cladribine+Cytarabine+Granulocyte Colony-stimulating Factor (D-CLAG) for Relapsed or Refractory Acute Myeloid Leukemia (AML)

A prospective, single-arm, multicenter, exploratory study to evaluate the efficacy and safety of D-CLAG regimen in the treatment of relapsed or refractory acute myeloid leukemia


Eligibility Criteria:
Inclusion Criteria:

* Acute myeloid leukemia (non-acute promyelocytic leukemia) must be diagnosed before enrollment. Diagnostic criteria refer to WHO (World Health Organization) classification.
* Refractory or relapsed AML: refractory is defined as the failure of CR after 2 courses of standard induced remission therapy (2 courses of idarubicin+cytarabine (IA) regimen or 1 course of IA regimen + 1 course of high dose cytarabine); Relapse is defined as the blast cells \>5% in bone marrow or presence of extramedullary leukemia for patient who achieved CR before.
* Age 18-70.
* Eastern cancer cooperation group (ECOG) ≤2.
* Creatinine clearance ≥30 mL/min (estimated glomerular filtration rate (eGFR) according to the Cockcroft-Gault formula or Modification of Diet in Renal Disease (MDRD) formula).
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3× upper limit of normal range (ULN), total bilirubin ≤2×ULN.
* Echocardiography (ECHO) showed left ventricular ejection fraction (LVEF)≥50%.
* Life expectancy \>8 weeks.
* Voluntarily sign the informed consent and understand and comply with the requirements of the study.

Exclusion Criteria:

* White blood cell (WBC) \> 50 \* 109 / L
* Patients who have received salvage treatment with D-CLAG.
* Current active cardiovascular disease, such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease according to the New York heart association (NYHA) functional classification, or a history of myocardial infarction within 6 months prior to screening.
* Other serious diseases that may limit patient participation in the trial (e.g. progressive infections, uncontrolled diabetes).
* Pregnant or nursing women.
* Unable to understand or follow the research protocol or unable to sign the informed consent.
Evaluative Conditioning: A Brief Cognitive Intervention Aimed to Modify Addiction Behaviour of Alcohol-dependent Patients

Evaluative Conditioning: A Brief Cognitive Intervention Aimed to Modify Addiction Behaviour of Alcohol-dependent Patients


Eligibility Criteria:
Inclusion Criteria:

* Participants in this study will be patients:
* With an alcohol use disorder according to DSM 5
* Follow-up at the Laborit Hospital Center
* Aged between 18 and 70 years with informed consent after receiving written information
* Engaged in a process to reduce alcohol consumption
* With a score of MOCA\> 20
* Whose mother tongue is French
* Patients benefiting from social security or benefiting from it through a third party in accordance with the french law on research involving the human person.

Exclusion Criteria:

* - Patient with less than 6 Heavy Drinking Days in the month
* Patient with Schizophrenia
* Patient with bipolar disorder Type 1
* Patient with Korsakoff syndrome or degenerative neurological disorder
* Patient with hearing impairment, uncorrected visual impairment
* Patient under curatorship or guardianship
* Patient with addiction to another substance other than tobacco
* Patient already enrolled in another interventional study
* Pregnant or nursing woman
* Patient with difficulties of expression or comprehension in French
* Patients in emergency situations or unable to give their consent.

Output Criteria:

* Patient who has manifested verbally or in writing, the desire to leave the study in progress.
* Patient who will be hospitalized during the study for a problem related to his addiction.
Imaging Response to Immunotherapy and Radiation Therapy in Patients With Liver Metastases

Patients will be imaged with MRE at the time of the RT planning MRI, prior to the induction of RT and immunotherapy. Research imaging will be in addition to standard imaging studies performed at time points consistent with the standard of care (at the time of the RT planning MRI and the first clinical follow-up). An additional MRE exam will be performed at the end of treatment outside the standard of care imaging.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of solid cancers with the presence of one or more liver metastases
* Minimum metastasis diameter ≥ 2 cm
* Planning to receive radiation therapy with immunotherapy
* Willingness to participate in mandatory imaging studies at Mayo Clinic Rochester

Exclusion Criteria:

* Contraindications for MRI including claustrophobia, pace maker, metal implants, aneurism clips
* Patients who are not able to consent
Effectiveness of Aspirin in Compare With Heparin Plus Aspirin in Recurrent Pregnancy Loss Treatment

This study evaluated the effect of anticoagulant treatment on the live-birth rate in women with a history of at least two continuous unexplained miscarriages or thrombophilia. It also compared two methods of treatment with aspirin and aspirin plus heparin.


Eligibility Criteria:
Inclusion Criteria:

* unexplained recurrent miscarriage,
* women had previous venous or arterial thromboembolism or who were heterozygous or homozygous for mutations for FV Leiden G1691A, prothrombin gene G20210A (FII G20210A), and methyltetrahydrofolate reductase C677T (MTHFR C677T)

Exclusion Criteria:

* abnormal karyotypes of both partners,
* uterine and cervical anatomical disorders on pelvic ultrasonography or hysteroscopy,
* abnormal ovaries and abnormal endocrine tests.
Venous Thrombo-Embolism Imaging Database (VTE-ID)

The purpose of this study is to identify and validate new imaging biomarkers allowing an individual phenotyping of patient with venous thrombo-embolism (VTE), mainly in terms of recurrence risk assessment and to distinguish provoked from unprovoked VTE. To do so, the investigators will create a retrospective imaging database including multiple imaging modalities, performed at diagnosis of the VTE.

Using a large imaging data in VTE (including ultrasound, CT-scan and Ventilation/Perfusion lung scan), the investigators will search for association between imaging data and VTE phenotypes, mainly in terms of recurrence risk assessment and to distinguish provoked from unprovoked VTE. Then, using a radiomic approach, the investigators will try to identify new imaging biomarkers able to provide an individual phenotyping in these patients.

These imaging biomarkers will be validated using an internal cross validation technique.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older.
* Confirmed VTE diagnosis (deep vein thrombosis or pulmonary embolism).
* Inclusion in the EDITH (Etude des Déterminants et Interaction de la THrombose veineuse) between November 2009 and November 2019.
* No opposition to be included in the present study.

Exclusion Criteria:

* Patients under 18 years old.
* Patients under judicial protection.
* Patient physically or cognitively unable to give consent.
* Refusal to participate.
Milrinone Pharmacokinetics and Acute Kidney Injury

Acute kidney injury (AKI) occurs in 40% of children following heart surgery. Serum creatinine (Scr) is a late biomarker of AKI, rising 24-48 hours after surgery. Thus, for medicines excreted in the urine, AKI could potentially lead to toxic levels in the blood. Urinary biomarkers have the ability to detect AKI earlier. Whether early detection of AKI through urinary biomarkers can predict altered drug levels is unknown.

Milrinone is used to improve heart function after surgery, but accumulates in AKI resulting in low blood pressure. Dose adjustments are not currently possible because of the late rise in SCr, and are based on clinical parameters that may lead to clinically relevant over or under-dosing. Thus, this study will address an important knowledge gap being the first to use elevations of AKI biomarker concentrations to anticipate increased milrinone levels.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing cardiothoracic surgery with cardiopulmonary bypass
* weight greater than 2500 grams (5 pounds 8 ounces) at the time of surgery
* gestational age \> 36 weeks
* age less \< to 1 year
* infants with complex congenital heart disease
* use of milrinone in the intra-operative and post-operative period.

Exclusion Criteria:

* Pre-existing kidney disease (structural and functional abnormalities) as determined by the Principal Investigator
* use of aminoglycosides within 48 hours of planned surgery
* cardiac arrest prior to cardiac surgery
* extracorporeal membrane oxygenation prior to cardiac surgery
* urinary tract infection prior to surgery
* repair of an isolated atrial or ventricular septal defect
Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension

This is a Phase 3 trial to evaluate the BP-lowering effect of lorundrostat (an aldosterone synthase inhibitor) in subjects with uncontrolled and resistant hypertension taking between 2 and 5 anti-hypertensive (AHT) medications.

This study is a Phase 3 trial to evaluate the BP-lowering effect of lorundrostat (an aldosterone synthase inhibitor) in subjects with uncontrolled and resistant hypertension taking between 2 and 5 anti-hypertensive (AHT) medications, one of which must be a thiazide or thiazide-like diuretic.

The study consists of a 2-week screening period with a 2-week single-blind run-in period followed by a 12-week randomized, double-blind, placebo-controlled, parallel arm period. Following the randomized period subjects will be offered an opportunity to participate in an open-label extension (OLE) study. Any subject electing to not participate in the OLE will undergo an end of study (EoS) visit, which will occur after end of treatment (EoT), to complete their participation in the study.

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age at the time of signing the informed consent form (ICF)
2. At Screening and Randomization: AOBP SBP of ≥135 and ≤180 mmHg plus AOBP DBP of ≥65 and ≤110 mmHg, or AOBP DBP of ≥90 and ≤110 mmHg
3. Taking between 2 and 5 AHT medications,
4. History of hypertension lasting at least 6 months prior to Screening
5. Body mass index (BMI) of ≥18 kg/m2 at Screening

Exclusion Criteria:

1. Women who are pregnant, plan to become pregnant, or are breastfeeding
2. Participation in a study involving any investigational device or small-molecule drug within 4 weeks or 6 months for biologic (antibody) drugs prior to the Screening Visit
3. eGFR \<45 mL/min/1.73m2 at Screening, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
4. Serum potassium \>5.0 mmol/L at Screening or \>4.8 mmol/L at Randomization
5. Serum sodium \<135 mmol/L (corrected for hyperglycemia) at Screening.
6. History of heart failure, myocardial infarction, stroke, or transient ischemic attack within 6 months prior to the Screening Visit.
Teriflunomide Male Transmission Study

It is known that teriflunomide, a treatment for relapsing forms of multiple sclerosis, can be found in low concentrations in semen. Because the drug has been associated with teratogenicity in laboratory animals, the question is raised as to whether the drug can be detected in female partners of sexually active males who are taking the drug to treat their multiple sclerosis.

A total of 10 couples were enrolled in the study. Females partners had undetectable or borderline levels of teriflunomide.

Eligibility Criteria:
Inclusion Criteria:

1. Males with relapsing forms of multiple sclerosis appropriately treated with teriflunomide 14 mg po daily;
2. Continuous treatment for three months with good compliance as assessed by the investigator
3. Age between 18 and 55
4. Penile-vaginal intercourse with a female partner at least twice a month with unimpeded ejaculation.
5. Compliance with safety assessments, e.g., regular bloodwork for complete blood count and liver function testing as recommended in the Package Insert
6. Able to give informed consent

Females

1. Regular sexual intercourse with a male partner who is actively taking teriflunomide
2. Age between 18 and 55
3. Able to give informed consent
4. Negative urine pregnancy test at the time of blood sampling
5. Reliable contraception that does not involve barrier methods

Exclusion Criteria:

1. Use of barrier methods of contraception
2. For males, contraindications to the continued use of teriflunomide
3. Couples that are actively trying to conceive
4. For males, noncompliance with teriflunomide therapy
5. Inability or unwilling to give consent or comply with the protocol
6. Pregnancy of the female sexual partner.
Risk Stratification of Heart Failure in Cardiomyopathies.

The investigators aimed to use CMR technique in helping diagnose the etiology of unknown cardiomyopathy. Try to make a risk stratification of susceptible heart failure based on the extent of myocardial impairment.

Cardiomyopathy is a category of multiple causes of myocardial injury in structure and function, of which unexplained cardiomyopathy was most worried by cardiologists. Since the etiology confirmation sometimes still lacks of effective tools, therefore it can not be treated against etiology and may gradually developing to systolic or diastolic heart failure. The development of heart failure can be in different speeds, varying degrees, inconsistent in reversibility, and distinct response to treatment of heart failure.

In "real-world", ECG , cardiac ultrasound and myocardial enzymology can not be the whole to indicate the etiology of heart failure, so a strong clinical tool in the existing auxiliary examination is urgently needed and help to assess the risk of potential heart failure, therefore a reasonable treatment time window can be proposed.

The investigators aimed to use CMR technique in helping diagnose the etiology of unknown cardiomyopathy. Try to make a risk stratification of susceptible heart failure based on the extent of myocardial impairment.

Eligibility Criteria:
Inclusion Criteria:

* Participants with cardiomyopathy diagnosed by medical history, clinical symptoms, laboratory tests including ECG, echocardiography.
* no known etiology of cardiomyopathy was confirmed.

Exclusion Criteria:

* with contraindications of magnetic resonance include: 1, participants with cardiac pacemakers and nerve stimulator; 2, participants who have done aneurysm surgery and intracranial with aneurysm folder; 3, participants with the metal foreign body in the eye; 4, pregnant women; 5, critically ill participants need life support systems; 6, epilepsy participants; 7, claustrophobic participants;.
* participants who are \<15 years of age or \>75 years.
* participants who have the contraindication use of contrast media: glomerular filtration rate \<30 ml/min
Investigation of Pain During Subcutaneous Injections With Different Injection Speed and Volume Combinations

This trial is conducted in Europe. The aim of this trial is to assess and describe the pain in relation to subcutaneous (under the skin) injection of different combinations of injection speed and volume with respect to acceptance of the injection pain and backflow.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities.
* Type 1 or type 2 diabetes
* Daily injection(s) with anti-diabetic drug (insulin or Glucagon like Peptide-1 (GLP-1) analogues) via pen-injector or vial/syringe for more than 6 months
* Body mass index (BMI) between 18.5 and 30.0 kg/m\^2 (both included)
* Caucasians

Exclusion Criteria:

* Known or suspected hypersensitivity to needle, ink ball pen or other that are in contact with the injection area during the clinical visit
* Previous participation in this trial. Participation is defined as: screened
* Receipt of any investigational medicinal product that can influence pain perception within 14 days before screening
* Injection of more than 40 units of insulin per injection
* Continuous Subcutaneous Insulin Infusion use within the last 6 months
* Continuous Glucose Monitoring use within the last 6 months
* Intake of any pain-relieving or analgesic within the last week (excluding low dose aspirin in cardio vascular prophylactic doses)
* Known active or in-active skin disease in the injection area or that may affect pain perception
* Anti-coagulant treatment within the last month (low dose of aspirin in cardiovascular prophylactic doses is allowed. However, not on the day of the injections)
This Study is to Compare the Efficacy of ZD6474 and ZD1839 in Subjects With NSCLC.

The purpose of this study is to compare the efficacy of ZD6474 and ZD1839 in patients with NSCLC after Failure of Prior Platinum-based Chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Failure of either first-line and/or second-line chemotherapy either of which was platinum-based (the prior regimen must have failed the subject because of toxicity or progression of tumor
* Prior histologic or cytologic confirmation of locally advanced or metastatic (IIIB/IV) NSCLC

Exclusion Criteria:

* Subjects who have received second-line or subsequent chemotherapy
* Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic, need not be excluded)
Management of Postoperative Pain After Total Hip Arthroplasty

Orthopedic surgery is reportedly among the most painful surgical procedures. Surgical damage following major orthopedic surgery often involves a large, deep incision with considerable tissue dissection and muscle, bone, and vascular exposure. Post-operative pain after such surgery is exacerbated on movement or by reflex spasms of the muscles, which may delay mobilization, reduce satisfaction, prolong hospitalization, and possibly increase medical costs.

We design a prospective randomized study for postoperative pain control following total hip arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed for surgery of osteoarthritis of hip
* ability to tolerate surgery under general anesthesia.

Exclusion Criteria:

* refusal or the lack of mental ability to provide informed consent
* neuropathic pain or sensory disorders in the leg requiring surgery
* previous surgery of the hip joint
* coagulation abnormalities
* severe renal or hepatic impairment
* chronic opioid users
* known history of intolerance to the drugs used in the study
Clinical Study to Investigate the PK, Efficacy, and Safety of Wilate in Patients With Severe Hemophilia A

The purpose of this study is to obtain additional data on the safety and efficacy of Wilate in PTPs with hemophilia A with at least 150 previous exposure days (EDs) to a FVIII concentrate who undergo prophylactic treatment with Wilate for 6 months and at least 50 EDs, thus supplementing the existing database to obtain approval of Wilate for the indication hemophilia A in the USA.


Eligibility Criteria:
Inclusion Criteria:

1. Severe hemophilia A (\<1% FVIII:C) according to medical history
2. Male patients aged ≥12 years
3. Previous treatment with a FVIII concentrate for at least 150 exposure days (EDs)
4. Immunocompetence (CD4+ count \>200/µL)
5. Good documentation of the historical bleeding rate (at least for the 6 months preceding study start)
6. Voluntarily given, fully informed written and signed consent obtained by the patient (or parent/legal guardian in case of adolescents) before any study-related procedures are conducted

Whenever possible, the interval between the Screening Visit and the PK or Non-PK Visit should not exceed 30 days. If the 30-day interval is exceeded, determination of the CD4+ count is to be repeated and must be \>200/µL for patients to be enrolled (i.e., exclusion criterion no. 4).

Exclusion Criteria:

1. Any coagulation disorders other than hemophilia A
2. History of FVIII inhibitor activity (≥0.6 BU) or detectable FVIII inhibitory anti-bodies (≥0.6 BU using the Nijmegen modification of the Bethesda assay) at screening, as determined by the central laboratory
3. Severe liver or kidney diseases (alanine aminotransferase \[ALAT\] and aspartate transaminase \[ASAT\] levels \>5 times of upper limit of normal, creatinine\>120 µmol/L)
4. Patients receiving or scheduled to receive immunomodulating drugs (other than anti-retroviral chemotherapy) such as alpha-interferon, prednisone (equivalent to \>10 mg/day), or similar drugs
5. Treatment with any investigational medicinal product in another interventional clinical study currently or within 4 weeks before enrollment