cyrilzakka/clinical-trials huggingface dataset:
Left Atrial Appendage Occlusion Guided by 3D Printing

Left atrial appendage closure (LAAC) was approved by the ESC guidelines as a stroke prevention alternative to warfarin for patients with nonvalvular atrial fibrillation in patients at high risk of bleeding (IIbB).

Although the overall LAAC benefice, in term of prevention of stroke or embolisme and decresing the anticoagulant-related risk of bleeding is already demonstrated, however the procedure success and safety, critically depends on understanding LAA anatomy and adequate pre-procedure planning.

3D-printed patient-specific adaptive and flexible LA models have demonstrated in a previous study an improving in LAAO device sizing, a better pre-procedural planning of the optimal trans-septal puncture site, by incorporating all anatomical variations and an improuving patient outcomes by reducing procedure time and number of prostheses employed per patient.

This technique is now used in several surgical centers in France and large prospective evaluation of the practice is necessary.

The 3D printing has modified the LAAC practices with a preoperative time allowing an optimal preparation of the prosthesis. This technique is now used in several surgical centers and prospective evaluation of the practice is necessary.

The objective of our research is to demonstrate the reduction of the operating time and number of prosthesis used per procedure when prior LAAC simulation testing and sizing is made on a 3D printed model.

It is therefore a longitudinal research to monitor professional practices for the evaluation of a new preoperative approach.

Procedures guided by 3Dprinted models will be compared (intention to treat population) in term of procedural parameters (procedure time, success rate, number of prosthesis per procedure) and procedural complication with prior Watchman study: post-FDA Approval US experience and national registries data. A second analysis (per protocol population) will be performed to compare patients with an informative utilization guided by 3D printed to those of the post-FDA Approval US experience and national registries.

Eligibility Criteria:
Inclusion Criteria:

* non valvular AF
* adressed for LAAC procedure

Exclusion Criteria:

* opposition from patients
Efficacy and Safety of Caspofungin for Invasive Pulmonary Aspergillosis Underlying Chronic Obstructive Pulmonary Disease

The investigators propose to study the efficacy and safety of three-week antifungal therapy with caspofungin in hospitalized patients with proven or probable IPA underlying chronic obstructive pulmonary disease.

Recently, there has been increasing appreciation of chronic obstructive pulmonary disease (COPD) as an important risk factor of invasive pulmoanry aspergillosis (IPA). However, clinical data on the morbidity and mortality of IPA underlying COPD as well as the efficacy and safety of antifungal treatment in such subset of patient population is very limited. In clinical pratice, capofungin is often used as primary antifungal therapy for IPA, especially in patients with impaired renal function. Based on this data, the investigators propose to study the efficacy and safety of three-week antifungal therapy with caspofungin in hospitalized patients with proven or probable IPA underlying COPD.

Eligibility Criteria:
Inclusion Criteria:

* Proven invasive pulmonary aspergillosis
* Probable invasive pulmonary aspergillosis
* Hospitalized in respiratory wards
* Not having received an empirical antifungal therapy for 72h before inclusion

Exclusion Criteria:

* A history of allergy to echinocandins
* Severe renal failure, severe hepatic insufficiency
* Inadequately treated bacterial infection
* Documented HIV infection
* Status of pregnancy or lactation
Effect of Plyometric Exercises on Upper Extremity Function in Children With Unilateral Cerebral Palsy

Plyometric training includes muscle contraction that moves rapidly from the eccentric to the concentric phase of movement while using proper biomechanics. It is an effective neuromuscular stimulus that can improve motor functions of children with CP. In plyometric training, muscles exert maximum force in short intervals of time, with the goal of increasing power.

This is a prospective double-masked randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

- spastic hemiplegia

Exclusion Criteria:

- fixed deformities
Chronic Pain After Childbirth - Caesarean Section Compared to Vaginal Delivery and the Impact of Pre-existing Pain

There is no doubt, that surgery is very often the beginning of a chronic pain disorder. C-section is a worldwide performed operation with increasing trend in the developed countries .This prospective cohort study evaluated the incidence of persistent pain after childbirth in respect of the pain status before childbirth and the modus of delivery.

There are different variables that may influence the occurrence of chronic pain after childbirth. One of these could be c- section , pain status before childbirth or other psychological factors like fear of birth, irrational cognitive beliefs about delivery and perinatal complications. The pain status (intensity and location), demographic data, anesthesiological details and data about the circumstances of birth are evaluated by structured interview during pregnancy and 3 month and 12 moth after childbirth. The pregnant women received an individual code for access to the survey on the website of the study. The recruitment takes placed in doctors or midwifes office and by advertising. The commuting area was the city of Tuebingen (Germany). Women who feel uncomfortable with the media based survey supplied a written form. Study population is planned with 500 participants. The Institute for Clinical Epidemiology and Applied Biometry support the statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* age of consent
* must be german-speaking

Exclusion Criteria:

- no written consent
Comparison of Smart-Shear Wave Elastography and Transient Elastography

The aim of this prospective study was to evaluate the applicability and diagnostic performances of Smart-Shear wave(SSW) imaging, in comparison with Transient elastography(TE) for the staging of liver fibrosis using pathologic results as the reference standard.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with liver disease: plan to undergo liver surgery
2. Potential liver donors
3. Smart-Shear wave \& transient elastography were performed within one month from liver surgery
4. Aged between 20 to 80 years
5. Compliance with scheduled visits, evaluation plans and other study procedures

Exclusion Criteria:

1. Previous history of hepatic surgery
2. Previous history of transarterial chemoembolization
3. Huge or infiltrative tumor in the right lobe of the liver
4. Bile duct dilatation in the right lobe of the liver
5. Older than 80 years
6. The opinion of the investigator would make the patient unsuitable for enrollment
Postmastecomy Internal Mammary Nodal Irradiation for High-risk Breast Cancer Patients

The purpose of this study is to evaluate the impact of internal mammary nodal irradiation on disease-free survival in high-risk breast cancer patients treated with mastectomy.

Eligible patients are randomized into 2 groups: chest wall and supraclavicular nodal +-axillary plus internal mammary nodal irradiation, and chest wall and supraclavicular nodal +-axillary nodal irradiation. The prescription dose is 50 Gy in 25 fractions over 5 weeks or 43.5Gy in 15 fractions over 3 weeks.

During and after radiotherapy, the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group Performance Status Scale 0-2
* Histologically confirmed invasive breast cancer
* Underwent total mastectomy and axillary dissection(10 or more axillary lymph nodes detected) and negative margins
* Patients who had ≥4 positive axillary lymph nodes; or 1-3positive axillary lymph nodes and T3-4; or 1-3positive axillary lymph nodes and T1-2, and score≥3 based on the following high risk factors: age≤40 years(score 1), primary tumor in the inner quadrant (score 1), 2-3 positive axillary lymph nodes (score 1), positive vascular invasion (score 1), re-staged based on eighth Cancer Staging System staging system(IB-IIA score 1， IIB-IIIA score 2); or ypN+ after neoadjuvant chemotherapy
* No supraclavicular or internal mammary nodes metastases based on images before system therapy
* No distant metastases
* Could tolerate radiotherapy
* Treated with chemotherapy (anthracycline and/or taxane-based combined chemotherapy, ≥6 cycles)
* Anticipated to receive endocrine therapy for 5 years if indicated
* Anticipated to receive anti-HER2 therapy for 1 years if indicated
* LVEF≥50% based on echocardiogram
* Willing to follow up
* Written,informed consent

Exclusion Criteria:

* Simultaneous bilateral breast cancer
* Sentinel lymph node biopsy only without axillary dissection
* Had received internal mammary node dissection
* No imaging assessment of the internal mammary nodal before system therapy
* One-stage breast reconstruction
* Severe cardiac insufficiency; myocardial infarction or uncorrected unstable arrhythmia or uncorrected unstable angina in the last 3 months; pericardial disease
* Had history of chest wall or supraclavicular radiotherapy
* Had simultaneous or previous secondary malignancies, except for non-malignant melanoma skin cancer, papillary thyroid / follicular carcinoma, cervical carcinoma in situ, contralateral non-invasive breast cancer
Validation of the French Version of the Lithium Knowledge Test (LKT)

Lithium is a drug used to treat several psychiatric illnesses. This medication requires particular vigilance because it has a narrow therapeutic margin: the dose necessary to obtain an effective treatment is close to the toxic dose.

The blood dosage of the drug and the patient's knowledge of the drug are necessary to optimize and secure the drug intake.

The objective of this observational study is to confirm that the score obtained by the LKT lithium knowledge self-questionnaire translated into French is representative of the knowledge of patients treated with lithium.

Participants will be asked to complete this questionnaire twice, and the scores obtained will be compared to the blood lithium level to see if a good score is associated with an effective blood lithium concentration.


Eligibility Criteria:
Inclusion Criteria:

* Patient hospitalized in a psychiatric ward or in an EPSM for more than 10 consecutive days
* Patient treated with IR or ER lithium LI
* Patient over 18 years of
* Patient on a fixed dosage of lithium for more than 5 days prior to blood sampling for lithiaemia testing
* Obtain patient's non-opposition

Exclusion Criteria:

* Clinically unstable patient or patient with a cognitive disorder that makes it impossible to perform interview and/or completion of the LKT self-questionnaire
* Patients under guardianship or trusteeship
* Illiterate patients
* Patient with a therapeutic target concentration different from general recommendations (e.g. elderly subject)
* Patient receiving a pharmaceutical interview or any other interview between the completion of the 1 and 2nd questionnaires, likely to modify the LKT score.
Intestinal Permeability and Gastroparesis

The purpose of this study is to investigate potential mechanisms that could lead to the development of a condition known as gastroparesis.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18-75 years old).
* Men and women.
* Patients with gastroparesis.

Exclusion Criteria:

* Patients will be excluded from the study if symptoms are thought to represent an organic disorder (e.g., peptic ulcer disease, hepatitis, pancreatitis, inflammatory bowel disease, a known malignancy, radiation-induced injury, an active infection, vasculitis, celiac disease), GERD, esophagitis, eosinophilic esophagitis or H. pylori.
* Patients with uncontrolled diabetes mellitus (hemoglobin A1C \> 10).
* Patients with prior surgery to the esophagus, stomach or duodenum.
* Patients taking opioids, steroids, anti-histamines, immunosuppressive agents, NSAIDs, or mast cell stabilizing agents within the prior 3 months.
* Patients currently prescribed aspirin or aspirin regimens for other clinical reasons.
* Patients with known allergies to lactulose: mannitol will be excluded.
A Study of PRA023 in Healthy Volunteers

This is randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRA023 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Male or female (of non-childbearing potential only) between minimum adult legal age (according to local laws for signing the informed consent document) and 55 years of age.
* Females must be of non-childbearing potential and must have undergone one of the following sterilization procedures, and have official documentation, at least 6 months prior to the first dose:

  1. hysteroscopic sterilization;
  2. bilateral tubal ligation or bilateral salpingectomy;
  3. hysterectomy;
  4. bilateral oophorectomy, or;
  5. be postmenopausal with amenorrhea for at least 1 year prior to the first dose and have FSH serum levels consistent with postmenopausal status as per investigator judgment.
* Male subjects must use reliable forms of contraception during sexual intercourse with female partners from screening to 30 days after the end of dosing.
* Good general health as determined by medical history, and by results of physical examination, chest x-ray, vital signs, ECG, and clinical laboratory tests obtained within 28 days (4 weeks) prior to study drug administration.

Exclusion Criteria:

* History or presence of any clinically significant organ system disease that could interfere with the objectives of the study or the safety of the subjects.
* Blood pressure and heart rate are outside the ranges 90-140 mmHg systolic, 60-90 mmHg diastolic, heart rate 60-100 beats/min.
* 12-lead ECG with any abnormality judged by the Investigator to be clinically significant, QRS \>= 120 milliseconds (msec), or QTcF interval of \> 450 msec for men or \>470 msec for women.
* Presence or history of any abnormality or illness, which in the opinion of the Investigator may affect absorption, distribution, metabolism or elimination of the study drug.
* Any screening laboratory evaluation outside the laboratory reference range that is judged by the Investigator to be clinically significant.
* History of or current active tuberculosis (TB) infection; history of latent TB that has not been fully treated or current latent TB infection as indicated by a positive QuantiFERON-TB test.
* History of significant allergy to any medication as judged by the Investigator.
* History of alcohol or drug abuse within the past 24 months.
Serum Soluble Endoglin and Matrix Metalloproteinase 14 With Elisa Method in Early/Late-onset Preeclampsia

Objective: Defective placentation and inadequate trophoblastic invasion have an important place in the aetiology of preeclampsia (PrE). Trophoblasts invade the maternal decidua and remodel spiral arteries with matrix metalloproteinase-14 (MMP-14). To the best of our knowledge, studies of MMP-14 protein levels of PrE patients' sera remain unpublished. This study aims to investigate the value of serum MMP-14 and soluble endoglin (s-ENG) in PrE patients and healthy controls.

Methods: The study was conducted with 30 late-onset preeclampsia patients (L-PrE) as group1 (gestational age≥34 weeks), 33 patients with normal pregnancies as group2 (gestational age≥34 weeks), 31 early-onset preeclampsia patients (E-PrE) as group3 (gestational age\<34 weeks), and 31 patients with normal pregnancies as group 4 (gestational age\<34 weeks). Serum MMP-14 and s-ENG levels measured by ELISA were compared.

The study was conducted at Cengiz Gokcek Women's and Children's Hospital, Gaziantep, Turkey at department of obstetrics and gynecology between date of January 2018 and December 2018. The study protocol was designed according to the Declaration of Helsinki, and the institutional ethical review board of Gaziantep University approved the study (Reference number: 2018/91). One hundred twenty-five women enrolled in the study in four groups. The investigators consecutively recruited 61 pregnancies complicated with preeclampsia, and 64 healthy pregnancies will select for the control group. All participiants gave their oral and written informed consent before their inclusion in the study.

Eligibility Criteria:
Inclusion Criteria:

* preeclampsia
* healthy pregnancy

Exclusion Criteria:

* pregnant women with any systemic condition (such as chronic hypertension, diabetes mellitus, thyroid diseases, liver and kidney diseases)
* women with a history of drug use throughout pregnancy
* history of medication for PE treatment at the time of first admission
* patients who had fetal congenital abnormalities or genetic syndromes
* multiple gestations
* active labour
Sunitinib Intake Conditions in the Treatment of Patients With Renal Cell Carcinoma

This non-interventional study includes patients with advanced renal cell carcinoma who are treated with Sunitinib alone or combined with other systemic therapies. The aim of the trial is to increase knowledge about usage, dosage, efficacy and safety under conditions of routine use of Sunitinib.

Because State Food and Drug Administration (SFDA) exempted manufacturers from conducting clinical trials of Sunitinib in China, overall efficacy and safety data of Sunitinib in Chinese patients with renal cell carcinoma were deficiency. The investigators carried out this research project will be sufficient evidence, and help clinicians in China to make decision in real daily practice.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed, unresectable advanced renal cell carcinoma;
* Sunitinib as first-line treatment alone or combined with other therapies.

Exclusion Criteria:

* History of Grade 3/4 severe allergic reaction to Sunitinib or its metabolites
Dragon III: Neoadjuvant Chemotherapy (FLOT Versus SOX) for Gastric Cancer

Safety and efficacy study of neoadjuvant chemotherapy (FLOT versus SOX) for gastric cancer patients in high volume center of China

DRAGON III research, Neoadjuvant Chemotherapy (FLOT versus SOX) for Gastric Cancer, is an investigator initiated; phase II, open label, randomised controlled study. This study will be conducted and analyzed by the Gastrointestinal department（Unit III）of the Ruijin Hospital and the project is supported by the Institute of Digestive Surgery, Shanghai, which is a state key research center. This study will be monitored by the Clinical Research Center of the Ruijin hospital (Official body which is responsible to guide and monitor all types of research at Ruijin hospital). Primary endpoint and secondary endpoint is described above. The aim of this study to obtain preliminary result and further conduct a large scale multi-center randomised controlled trial(RCT) study.

Eligibility Criteria:
Inclusion criteria:

* Histology confirmed non-obstructive adenocarcinoma of the stomach or esophagogastric junction.
* Clinical stage: cTNM: stage III or above
* Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2 (normal to symptomatic but in bed less than half the day)
* Clinically fit for systemic chemotherapy and gastric cancer surgery, i.e. adequate renal, hepatic, hematologic, and pulmonary function.
* Written informed consent

Exclusion criteria:

* Clinically unfit for systemic chemotherapy and gastric cancer surgery, i.e. uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities, unable to undergo general anesthesia
* Confirmed distant metastases
* Locally advanced inoperable disease (Clinical assessment)
* Relapse of gastric cancer
* Malignant secondary disease
* Prior chemo or radiotherapy
* Inclusion in another clinical trial
* Known contraindications or hypersensitivity for planned chemotherapy
Keppra IV for the Treatment of Motor Fluctuations in Parkinson's Disease

The primary purpose of this study is to characterize the acute anti-dyskinetic properties of intravenous levetiracetam in Parkinson's disease patients who have been optimized on antiparkinsonian medication. The secondary objective is to study the effect of intravenous LEV on additional motor and cognitive symptoms of PD.


Eligibility Criteria:
Inclusion Criteria:

1. Outpatients with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria.
2. Age 30 years to 80 years.
3. Dyskinesias with a minimum severity equal to a rating of 10 or higher on the AIMS rating scale at baseline.
4. Dyskinesias at least moderately disabling (historical information from item 33 of UPDRS).
5. Stable dose of antiparkinsonian medication 4 weeks prior to study entry.
6. Women of child-bearing potential must use a reliable method of contraception and must be willing to perform a pregnancy test paid for and provided by Dr. Zesiewicz and the USF Medical Clinic. There must be a negative result before entry into the study.

Exclusion Criteria:

1. Any illness that in the investigator's opinion preclude participation in this study. This includes patients with unstable disease and those PD patients who can not tolerate IV infusion.
2. Pregnant or lactating women. Pregnancy will not be allowed whether as a pre-existing condition or a positive result on the pregnancy test in the screening process. Lactation includes any woman wanting to participate who is currently breast-feeding.
3. Patients may not be dual enrolled to another research study requiring the patient to sign informed consent.
4. Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam score of less than 20).
5. Legal incapacity or limited legal capacity.
6. Presence of severe renal disease (BUN 50% greater than normal). Patients must have evidence from their PCP or Urologists of normal PSA and urodynamic tests within the last 12 months; patients with BUN 50% greater than normal (5 to 20 mg/ d L) or creatinine 50% greater than normal (0 .7 and 1.4 mg/ d L) will be excluded. Labs will be requested from PCP.
7. Concomitant or prior therapy with the following treatments: neuroleptics, metoclopramide, domperidone (in doses \>60mg/day), azole antifungals (e.g. ketoonazole), etomidate, ciprofloxacin, fluvoxamine, cimetidine, fludrocortizone, encainide, flecainide, mexiletine, propafenone, guanoxane, maprotiline, antidepressants on doses higher than the maximum approved daily dose for outpatients, intermittent therapy with oral corticoids.
8. Patients who are not fluent in English.