cyrilzakka/clinical-trials huggingface dataset:
A Low-dose Radiation and Contrast Agent Exposure Protocol for Coronary CTA in Diabetic Patients

To assess diagnostic accuracy,image quality and renal safety of a double low-dose coronary CTA protocol at coronary artery evaluation in patients with diabetes by using invasive coronary angiography(ICA) as the reference method and to compare the results with those obtained traditional dose protocol. The study will randomly include about 400 consecutive participants aged 18 to 80 years old who had been diagnosed with diabetes and suspected coronary artery disease.All participants undergo ICA and coronary CT angiography performed with a whole-heart CT scan.Coronary segment interpretability,image quality based on a four-point Likert scale,blood indicators of renal function will be accessed between double low-dose CTA protocol and traditional CTA protocol. Investigators hypothesize that an individualized coronary CTA protocol that appropriately reduces radiation dose and contrast dose does not affect image quality and diagnostic accuracy, and can reduce the risk of kidney damage in high-risk patients.

The study has been approved by the local ethics committee and allparticipants will be provided written informed consent. Iodixanol 320 mg/ml is injected followed by 30 ml of saline solution.In the test group,the tube voltage,contrast agent volume and flow rate are adapted to cardiac ejection fraction(EF) and body mass index(BMI)according to the pretest. participants in the contract group are injected 50 ml contrast agent with the flow rate of 5 ml/s in tube voltage of 120 kVp. All participants are scanned in automatic tube current.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years old and ≤ 80 years old;
* patients who have previously diagnosed diabetes;
* patients with suspected coronary artery disease and undergoing coronary CT angiography (CTA);
* Subjects are fully informed and provided written informed consent.

Exclusion Criteria:

* The exclusion criteria are pregnancy and lactation women or recent birth planners
* patients with Iodine contrast agent contraindications (such as a history of severe allergy history with iodine contrast agents, hyperthyroidism, etc.)
* patients with chronic kidney disease (Phase 4-5, eGFR \<30 ml/min/1.73 m2)
* patients who have undergone coronary stent implantation or coronary artery bypass surgery
* patients who have received iodine contrast-related tests within 24 hours
* participated in other clinical trials within 3 months
* other circumstances that the investigator believes are not suitable for participation in the trial
Enteral and Parenteral Feeding in Critically Ill Patients

Supplementation of insufficient enteral nutrition with parenteral nutrition may optimize nutritional support and avert negative energy balance in critically ill patients, thereby improving outcome.

Malnutrition is a common and serious problem in intensive care units. Negative energy balance has been associated with increased morbidity and mortality in critically ill patients. The increased incidence of complications related to malnutrition correlates with increased length of hospital stay and overall health care costs. Although early enteral nutrition is the preferred method of feeding critically ill patients, enteral nutrition alone often fails to supply adequate calories and nutrients to critically ill patients, who are frequently hypermetabolic.

Artificial nutrition support has evolved into a primary therapeutic intervention to prevent metabolic deterioration and loss of lean body mass with the aim to improve the outcome of critically ill patients. Apart from the timing of initiation and the targeted amount of macronutrients, the route of delivery is viewed as an important determinant of the effect of the nutritional intervention.

Using the enteral route is considered to be more physiologic, providing nutritional and various non-nutritional benefits including maintenance of structural and functional gut integrity as well as preserving intestinal microbial diversity.

The disadvantage of enteral nutrition is related to a potential lower nutritional adequacy particularly in the acute disease phase and in the presence of gastrointestinal dysfunction.

In contrast, parenteral nutrition may better secure the intended nutritional intake but is associated with more infectious complications, most likely due to hyperalimentation and hyperglycemia.

Supplementation of insufficient enteral nutrition with parenteral nutrition may optimize nutritional support and avert negative energy balance in critically ill patients, thereby improving outcome.

Combining parenteral nutrition with enteral nutrition constitutes a strategy to prevent nutritional deficit but may increase risk of overfeeding, which has been associated with liver dysfunction, infection, and prolonged ventilatory support.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to CCU (critical care unit)who are in need for either enteral or parenteral during duration of the study will be included

Exclusion Criteria:

* No exclusion criteria
Effect of Bronchial Artery Protection on Cough After Thoracoscopic Lobectomy

The postoperative complications of thoracoscopic radical surgery for lung cancer mainly include postoperative bleeding, pulmonary infection, chylothorax, nerve injury, pulmonary embolism, arrhythmia, postoperative cough, bronchopleural fistula and so on. Among them, postoperative cough is one of the most common complications after lung surgery, and the incidence of postoperative cough is 25% - 50%. Cough after pneumonectomy can last for a long time, which affects the rapid recovery of patients after surgery, and brings serious adverse effects to the physiological, psychological and social functions of patients.

After pneumonectomy cough on patients' daily life will bring different degrees of adverse effects, so through certain methods to intervene, in order to reduce the incidence of postoperative cough, accelerate the rapid recovery of patients after surgery, improve the quality of life of patients, which should also be worthy of attention of surgeons. In recent years, the research on intervention measures and treatment methods to reduce cough after thoracoscopic lobectomy is mainly focused on drug treatment, traditional Chinese medicine treatment, surgical operation and anesthesia intervention. However, the research on reducing postoperative cough by improving surgical operation is rare. The purpose of this prospective study was to investigate whether preoperative three-dimensional reconstruction and intraoperative protection of bronchial artery can reduce the severity of cough after thoracoscopic lobectomy, so as to further explore the effective intervention measures of postoperative cough and enrich the concept of accelerated rehabilitation surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years, no matter male or female;No cough symptoms within two weeks before operation; Lung adenocarcinoma confirmed by pathology;Operation method: thoracoscopic lobectomy + systematic lymph node dissection；Preoperative abdominal B-ultrasound, skull CT / MRI, bone scan or PET / CT to exclude distant metastasis; ECG, lung function, cardiac ultrasound evaluation can tolerate the operation

Exclusion Criteria:

* There were cough caused by respiratory diseases, pharyngitis and rhinitis before operation; Pneumonia was indicated by chest X-ray or chest CT in recent month;Thoracoscopic surgery was converted to thoracotomy;Pulmonary arteriovenous angiography could not be performed in patients with allergy to contrast medium; Patients and their families refused to be enrolled and followed up.
The Effect of Masking on Subjective Results During Daily Disposable Contact Lens Studies

The purpose of this study is to explore the effect of masking on subjective ratings for two daily disposable contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* 17 years of age or older.
* Ocular exam within 2 years.
* Currently wearing soft contact lenses on a daily wear basis.
* Contact lens prescription between +6.00D and -10.00D.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any ocular disease.
* Use of systemic or ocular medications that may affect ocular health.
* Unable to achieve an acceptable fit with the study lenses.
* Anisometropia \>1.00D or astigmatism \>0.75D.
* Other protocol-defined exclusion criteria may apply.
Evaluation of the Potential Association Between 5α-reductase Inhibitors Prescription and Occurrence of High Grade Prostate Cancers

This is a multicenter, cohort study based on medico-administrative data from pathology laboratory registries and drug reimbursement files (CNAM-TS).

Identification process will be retrospective and prospective using medico-administrative data from all pathology laboratory registries in Brittany and drug reimbursement files for patients living in Brittany, France.

An extraction from drug reimbursement files of French health reimbursement agency (CNAM-TS) for patients living in Brittany, France will be performed on the following request: reimbursement of any pharmacologic treatment patented for symptomatic benign hyperplasia between January 1st 2010 and December 31st 2011, and no diagnosis of prostate cancer before December 31st, 2011. This extraction has to be done in 2013 to catch data as far as 2010 and will encompass health reimbursement for prostate examination. A second extraction will be done in 2014 to complete data from the end of 2013.

Secondly, identification of patients will use pathology laboratory registries, based on code for prostate examination (prostate biopsy, prostatectomy or prostate resection); involvement of all pathology laboratories in Brittany ensures completeness of collection of prostate examination results for the study period (January 1st, 2012 to December 31st, 2013). A list of patients will be recorded at each pathology laboratory level with date of birth, date of prostate examination, type of exam, results with Gleason score along with a study number on electronic file.

By January 2014, link to reimbursement file (that is data on all reimbursement within 3 years: 2009 to 2011 previously extracted from the French health reimbursement agency) will be done thanks to three key variables (date of birth, date of prostate examination, identification of pathology laboratory) and all data from all centers will set up into one global file.

This design will allow evaluation of association between 5-ARI and either high grade prostate cancer or low grade prostate as opposite association could be observed. In addition this design focuses on the target population, i.e. patients with symptomatic benign prostate hyperplasia, identified through reimbursement of drugs patented for symptomatic benign prostate hyperplasia.

Eligibility Criteria:
Inclusion Criteria:

* Men with a reimbursement of any pharmacologic treatment patented for symptomatic benign prostate hyperplasia between January 1st 2010 and December 31st 2011, affiliated to French health system and living in Brittany, France.

Exclusion Criteria:

* Prostate cancer with a date of diagnosis before December 31st, 2011, patients enrolled in surveillance program with scheduled prostate biopsy, patients not affiliated to French health system.
LASER and Radiofrequency for Treatment of Vaginal Vulvar Atrophy (VVA) in Women Treated for Breast Cancer (EPMLARF-arm2)

This is a randomized controlled trial to evaluate the use of LASER, Micro Ablative radiofrequency and topic promestriene to treat symptoms of vulvovaginal atrophy of women treated for breast cancer.

Women treated for breast cancer with moderate or severe signs or symptoms of vulvovaginal atrophy will be eligible for the study.

The patients will be randomized to receive one of the three intravaginal therapies: LASER, Micro Ablative radiofrequency or Promestriene. The applications will occur in the interval of 30 days for 3 times, for LASER and Radiofrequency groups. For the promestriene group, the application will be done by the patient, daily for 2 weeks and then twice a week for 3 months, and each 30 days, the patients will have an appointment when will be checked the weight of the promestriene tube, to verify the correct use.

The follow-up visits will occur 30, 90, 180 and 360 days after the conclusion of the third month of treatment.

Will be evaluated: vulvar and vaginal histology before and after the use of LASER, radiofrequency or estriol; microbiota and vaginal pH before and after the use of LASER, radiofrequency or promestriene; extracellular matrix and metalloproteinases in the remodeling of vulvovaginal collagen induced by promestriene, LASER and radiofrequency; quality of life, sexual dysfunctions and complains before and after the use of LASER, radiofrequency or hormones; metabolomics and vaginal microbiome.

Eligibility Criteria:
Inclusion Criteria:

1. Women with breast cancer treated with surgery and / or chemotherapy and / or radiotherapy, that has been concluded at least 6 months before inclusion, whether or not using aromatase inhibitor and complaining of vulvovaginal atrophy
2. To present, at least moderate, or severe intensity (score 4 or more of visual analog scale ( 0-10)) of one of the signs or symptoms of vulvovaginal atrophy:

   * Burning
   * Discomfort
   * Dryness
   * Cracks
   * Pruritus
   * Lack of vaginal lubrication
   * Penetration dyspareunia that began at the menopausal or postmenopausal transition
   * Decreased vaginal epithelium turgor and trophism
   * Deletion of mucous and skin folds.
3. Absence of vaginal surgical procedure in the last year
4. Genital prolapse stage no greater than stage II of Pelvic Organs Prolapse Quantitation (POP-Q) with Ba, Bp or C points less than or equal to 0

Exclusion Criteria:

1. Active genital infection
2. Active infection of HPV (human papillomavirus) or Herpes
3. users of medications with estrogenic effect (digoxin and other chemicals)
4. Postmenopausal genital bleeding
5. uncontrolled diabetes
6. use of multivitamins with zinc
7. use of copper or hormonal IUDs (intrauterine device) at the time of inclusion
8. presence of genitourinary or rectovaginal fistulas
Equivalence of Intramuscular (IM) Versus Subcutaneous (SC) Applications of Long Acting Pamorelin 11.25 mg

The purpose of this study is to demonstrate the pharmacodynamic equivalence of triptorelin pamoate (Pamorelin® LA 11.25 mg), applied either IM or SC, in terms of the area under the curve \[AUC1-85day\] for serum testosterone in patients with advanced prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven prostate cancer, locally advanced or metastatic, or rising PSA (prostate-specific antigen) after failed local therapy, and the patient scheduled to receive androgen deprivation therapy
* Serum testosterone levels ≥ 125 ng/dl (1.25 ng/ml, 1.25 microg/l, 4.3 nmol/l) measured by any laboratory or on site within the previous 6 months or at study start
* Karnofsky performance index \> 70
* Expected survival ≥ 9 months

Exclusion Criteria:

* Prior hormonal treatment for prostate cancer including gonadotropin-releasing hormone (GnRH) agonists or antagonists within the last 12 months preceding the study or concomitant treatment with one or more of these substance(s)
* Any current use or within 6 months prior to treatment start of medications which are known to affect the metabolism and/or secretion of androgenic hormones: ketoconazole, aminoglutethimide, oestrogens and progesterone
* Patient at risk of spinal cord compression or ureter obstruction
* Prior hypophysectomy or adrenalectomy
Mindfulness Training for Small Teams

The purpose of this study is to look at how mindfulness training may influence how the participant thinks, feels, and acts.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who are between 18 and 65 years of age
* Individuals who are fluent English speakers
* Individuals who are active-duty service members
* Men and women of all races and ethnicities

Exclusion Criteria:

* Individuals who have a medical or neurological condition that might interfere with performance on the task in the study (e.g., epilepsy)
* Individuals with a history of hospitalization for psychological/mental health issues within the last 6 months.
Evaluation of Autonomic System Before and After Anticholinergic Treatment in Women With Overactive Bladder

The aim of the study is to evaluate changes in autonomic nervous system following treatment with anticholinergic medication for OAB symptoms.

Heart variability as a measure of the functioning of the autonomic nervous system will be recorded before and three months following treatment with solifenacin succinate 10 mg daily.

30 women with clinical diagnosis of overactive bladder will be recruited for the study. An ECG strip for fifteen minutes at rest will be recorded through a 12-bit analog/digital data acquisition card (National Instruments, Austin TX) with a sampling frequency of 200 Hz and stored in a computer for offline studies. The digitized ECG signals will than processed and analyzed via dedicated robust software to detect the R wave peaks. The R point of each QRS complex was defined and the interval between two consecutive R points (the R-R interval) was computed. All R-R intervals will be visually inspected and manually edited if necessary to exclude background noise and artifacts. The edited segments accounts for less than 1% in each patient. A "clean" 2-5-min segment (preferably unedited) will be used for the analyses. An autoregressive model with the order of 16 was will be used to estimate the power spectrum densities of HRV. The power spectra are quantified by measuring the area under the following frequency bands: low-frequency (LF) (0.04-0.15 Hz) known to represents sympathetic activity, and high-frequency (HF) (0.15-0.4 Hz) which represents parasympathetic activity.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of OAB

Exclusion Criteria:

1) stress urinary incontinence and voiding symptoms, 2) pregnancy, 3) pathological conditions that can interfere with the ANS, (e.g. coronary heart disease, heart failure, or other cardiac conditions, hypertension, neurological diseases or diabetes , 4) medications that can interfere with the ANS, including beta-receptor agonists or antagonists, antiarrhythmic agents or antihypertensive drugs, anticholinergic agents or adrenergic alpha-antagonists, tricyclic or serotoninergic antidepressants.
Distribution of Helicobacter Pylori After Gastrectomy

The purpose of this study is to know the distribution of Helicobacter pylori in stomach before subtotal gastrectomy and after subtotal gastrectomy.

Endoscopy and biopsy will be performed to investigate the distribution of Helicobacter pylori before and after subtotal gastrectomy.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are indicated to subtotal gastrectomy due to gastric neoplasm
2. Aged between 19 to 75 years
3. Informed consent

Exclusion Criteria:

1. Previous history of Helicobacter pylori eradication
2. Previous history of proton pump inhibitor use within 6 months
Validation of Patient Reported Outcome Measures for Use in Hallux Valgus

The purpose of the study is to explore whether the mFFI is fit for purpose in adults with hallux valgus (HV).


Eligibility Criteria:
Inclusion Criteria:

* Male or female, of any race and, aged ≥ 18 years
* Clinical diagnosis of hallux valgus
* Fluent in reading/speaking US-English to read and understand informed consent form and to participate in the interview

Exclusion Criteria:

* Participation in another foot-based clinical trial in the last 90 days or in Ipsen's clinical trial D-FR-52120-237
* Current chronic drug or alcohol abuse problem
Normal Brain Imaging Database for Brain Disorder Studies

Healthy volunteers will be recruited. All subjects will be tested a battery of neuropsychological tests, then undergo fluorodeoxyglucose-positron emission tomography (PET) and magnetic resonance imaging (MRI). During the PET and MRI, they will be stimulated with transcranial direct current stimulation (tDCS) for 15 minutes. A third of subjects will receive real tDCS on the left prefrontal cortex, a third on the right prefrontal cortex, and the other third will receive sham tDCS.


Eligibility Criteria:
Inclusion Criteria:

* N/A

Exclusion Criteria:

* History of any neurological or psychiatric diseases;
* Abnormal MRI;
* metal implants or a cardiac pacemaker;
* Pregnant or breastfeeding women (female subjects of child bearing potential will be screened for pregnancy before MRI imaging).
* severe hypertension.
* cardiovascular disease.
* Family history of epilepsy.
An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD Patients

This is a multicenter, 6 months open label safety extension study for all patients who are willing and eligible to continue from the pivotal, double-blind S308.3.003 trial


Eligibility Criteria:
Inclusion Criteria:

* Patients who have completed S308.3.003 trial

Exclusion Criteria:

* Patients with medically relevant abnormal findings (ECG, physical examination, AEs) at end of the maintenance phase (visit M6, week 24) of study S308.3.003
Intensive Dysarthria Sessions in Adults and Children With Down Syndrome

This research study is designed to investigate the feasibility and treatment effects of a behavioral speech treatment in adults and children with Down Syndrome (DS) and dysarthria. The speech sessions will provide an intensive, articulation-based intervention focused on increasing effort during speech production via use of "clear speech." A single subject multiple baselines across subjects design will be employed in a total of six subjects divided into two groups of three. Changes in dependent measures will be determined by visual inspection, effect size determination, and time series analysis. The study follows accepted procedures in rehabilitation treatment and research and there are minimal foreseeable risks associated with participation.


Eligibility Criteria:
Inclusion Criteria:

* Adults and children with Downs Syndrome and dysarthria
* Ages 8 years and older
* Ability to verbally communicate; follow simple commands and/or imitate others; hear speech at a conversational level; and participate in assessment and speech sessions activities

Exclusion Criteria:

* Additional serious medical problems which prevent meaningful participation in the study.
Validation of Population Pharmacokinetic Model Derived From Healthy Volunteer in Kidney Transplant Recipients

Pharmacokinetic model to predict interaction between tacrolimus and mycophenolate was developed through clinical trial with healthy volunteer. The purpose of this study is to confirm predictability of developed pharmacokinetic model in kidney transplant recipients.

Study participants take their immunosuppressant as usual. One day, blood is drawn at predose and 1, 2, 3, 4-hour postdose to compare observed concentration with model-predicted concentration of tacrolimus and mycophenolate.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18 years or older
* At least 6 months after kidney transplantation
* Were on tacrolimus alone or tacrolimus plus mycophenolate based immunosuppressive regimen
* Maintained stable dose of immunosuppressants for at least two weeks

Exclusion Criteria:

* AST or ALT \>3 upper limit of normal range
* Had gastrointestinal disorder that may affect an absorption of drug
* Coadministration of drugs that may affect the pharmacokinetics of immunosuppressive drug
* Multi-organ transplant recipient
* Severe psychiatric disorder
* Drug or alcohol abuser
* Pregnant
* Low compliance