cyrilzakka/clinical-trials huggingface dataset:
Clinical Pilot-Study of ProEndoTecc Vascular Grafts as Superficial Femoral Artery Bypass / Interponate

This is a multi-center, clinical pilot-study of ProEndoTecc Vascular Grafts (6, 7 or 8 mm Diameter) as superficial femoral artery bypass/interponate.

The aim of this study is to demonstrate safety of implantation, patency and durability of a new type of vascular graft.


Eligibility Criteria:
Inclusion Criteria:

* Female or male patient from 18 to 89 years of age
* Superficial femoral artery occlusion from 5 to 40 cm in length (above the knee joint),
* Patient must present with intermittent claudication, with resistance to medical therapy and exercise or critical ischemia,
* Patient has Rutherford grade 3, 4, or 5 occlusive vascular disease,
* Women of childbearing age must have negative pregnancy test prior to inclusion

Exclusion Criteria:

* Bleeding diathesis
* Patient has known coagulation disorders including hypercoagulability
* Presence of one or several previously placed endo-prosthesis or grafts in the diseased extremity (below iliacs)
* Other than 6-8 mm diameter graft is needed.
* Patients PAD state is in Fontaine Grade IV, Rutherford Grade 6 (Patient has active infection or pronounced necrosis in the region of graft placement)
* Patient has an acute embolic arterial occlusion
* Life-expectancy less than 6 month due to co-morbidity or other situation that would make the patient an unlikely candidate for follow-up visits
* Patient had percutaneous transluminal angioplasty at the implant site within the previous 30 days
* Participation in another clinical study less than 30 days prior to inclusion
* Patient is in need of, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure
* Pregnant or breast feeding female patients
* Multiple graft (implant) needed
* Patients unable to understand the full meaning of the informed consent
* Subjects who, in the opinion of the investigator, will be inappropriate for inclusion into this trial or will not comply with requirements of the study
* Subjects who are imprisoned (according to MPG §20.3)
* Patients who are lawfully kept in an institution
* Participation in this trial at an earlier stage
* Current participation in another clinical trial
Mechanisms Linking Depression to Cardiovascular Risk

To examine the role of depression on risk for cardiovascular disease in twins.

BACKGROUND:

Multiple studies have demonstrated a higher risk of cardiovascular disease and worse cardiovascular disease (CVD) prognosis associated with depression that appear to synergistically and significantly adversely impact health. Because these initial studies are observational, much work remains to understand this area. If these conditions are mechanistically inter-related, identification of both conditions in the same subject may provide a means of enhancing risk stratification and most appropriately targeting therapy. If the interaction between the conditions is causal not simply associative, appropriate therapy interventions can be designed and tested.

DESIGN NARRATIVE:

The project is designed to clarify the role of depression on CVD risk by using a co-twin study design. The study will examine twin pairs from the Vietnam Era Twin Registry (VET). Twin pairs will be invited to participate if they meet two criteria: (1) neither has a history of CVD as of 1990 and (2) one twin is diagnosed with depression as of 1992. The study investigates the effects of depression on two indicators of "early" CVD: coronary flow reserve, assessed by means of Positron Emission Tomography (PET) myocardial infusion imaging; and heart rate variability (HRV) assessed by ambulatory electrocardiographic monitoring. It is hypothesized that within each pair, the twins who have clinical depression will exhibit lower coronary vascular reserve and lower heart rate variability compared with their co-twins without a history of depression. Moreover, by comparing the size of the intra-pair difference in these parameters between depression discordant monozygotic and dizygotic twins an estimate of the relative contributions of gene and environmental factors can be ascertained. In addition to the PET and HRV assessments, subjects will complete the Statistical Clinical Interview of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV SCID) to document a history of depression, a psychometric battery including the Early Trauma Inventory and Hamilton Depression Scale, and such risk factors as cigarette smoking, physical activity, blood pressure and blood lipids, glucose and insulin, indices of inflammation and thrombogenicity including levels of reactive protein C, fibrinogen, and P-selectin, and neurohormones such as adrenocorticotropic hormone, cortisol, and dehydroepiandrosterone sulphate.

Eligibility Criteria:
No eligibility criteria
Oral Glyceryl Triacetate (GTA) in Newborns With Canavan

Canavan disease is caused by Aspartoacylase deficiency. There is no treatment for the disease, but there is a food additive that includes acetate . We suggest an early treatment with acetate and a neurologic evaluation, including MRI, after 4 months of treatment. In any case the treatment will be stopped at the age of 22 months, when myelinization is ended.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of Canavan disease

Exclusion Criteria:

* Age above 18 months
Online Survey of Nutrition Status in Chinese Non-hospitalized Cancer Patients

This is a national-wide online survey, which aims to investigate the nutritional status and dietary intakes in Chinese discharged patients with cancer. It will provide relevant data for the "White Paper on Nutritional Diet of Cancer Patients in China", and also provide reference for the relevant work of nutrition support for cancer patients in clinical practice.

Nutritional status has significant impact on clinical outcome and quality of life in patients with cancer. Current surveys show that about 30-80% of patients with cancer have nutritional risk and/or malnutrition, and about 20% of the patients' death are directly caused by malnutrition. Appropriate and standardized nutrition therapy might not only improve the nutritional status, but also the clinical outcomes of patients with cancer, and improve their life quality and dignity.

At present, there is still lack of large-scale investigation and research on nutritional status and dietary intakes in discharged patients with cancer in China, and thus affects the overall level of nutritional management for cancer patients, as well as the formation of related guideline.

Therefore, we will conduct a national-wide cross-sectional online survey, which aim to investigate relevant data of nutritional status and dietary intakes among discharged patients with cancer. Data will be collected through an online semi-structured questionnaire using WeChat forms with a consent form. The link to the questionnaire was sent through emails, WeChat App groups, and other social media. The participants were encouraged to roll out the survey, and send the link to more patients as they could. On receiving and clicking the link, the participants will be directed to the information about the study and informed consent. After they accept to take the survey, they will fill up the demographic details and answer a set of questions related to nutritional status and dietary intake investigation.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of cancer Must be able to use WeChat or related social media Fully understood and voluntarily signed the informed consent

Exclusion Criteria:

Hospitalized patients Pregnant and lactating women Be known to have any psychiatric illness Refused to share the data or no network condition
The Effects of Isoflavones on Cardiovascular and Bone Metabolism Markers in Peritoneal Dialysis Patients

The aim of this double-blind randomized clinical trial is to determine the effects of isoflavones on cardiovascular disease risk factors, bone metabolism markers, serum concentrations of fructoseamine and advanced glycated end products in peritoneal dialysis patients. Forty-four patients from shafa clinic and Dr.najafi's clinic will randomly assign to either isoflavone or placebo group. The patients in isoflavone group will receive 100 mg soy isoflavone (as 2 capsules) daily for 8 weeks, while the placebo group will receive identical placebo. At the baseline and the end of the study,7 ml blood will be collected from each patient after a 12-14-hours fasting and serum concentrations of Lp (a), MDA, hs-CRP, sICAM-1, bone alkaline phosphatase, osteocalcin, N-telopeptide, osteoprotegerin, RANKL, iPTH, triglyceride, total cholesterol, HDL-C, LDL-C, fructoseamine, carboxymethyl lysine, pentosidine, glucose, albumin, calcium and phosphorous will be measured. Furthermore, blood pressure measurements will be performed twice with a ten-minute interval between testing


Eligibility Criteria:
Inclusion Criteria:

Continuous Ambulatory Peritoneal Dialysis for 6 months or more Body mass index below 35

Exclusion Criteria:

infections inflammatory diseases; liver diseases; past medical history of cancer receiving glucocorticoid and anti-inflammatory drugs receiving isoflavone supplements Constant consumption of soy or foods containing soy in the diet
A Post Marketing Observational Study of Activities of Daily Living in Advanced Parkinson's Disease Patients With Early Troublesome Motor Fluctuations and Treated With Duodopa - a Multi-country Study

Patients with advanced Parkinson's Disease experience a range in the severity of their motor fluctuations. The rationale for this Post Marketing Observational Study is to demonstrate the benefits of Duodopa treatment on Parkinson's Disease patients entering the advanced stage of the disease whose motor fluctuations have become troublesome and complicate management with oral therapy. The aim of this post-marketing observational study is to assess the effect of Duodopa treatment on activities of daily living in advanced Parkinson's Disease participants characterised by either 2-4 hours of "off" time or 2 hours of non-troublesome or troublesome dyskinesia daily, supported by a Unified Parkinson's Disease Rating Scale Total Score in the best "on" state of at least 40 points at baseline.

Data are recorded from visits most closely aligned with the planned periods of Visit 0 (V0): Baseline (After decision to use the temporary naso-duodenal tube (approximately 2-14 days) and after signature of the Patient Authorization/Informed Consent Form); Visit 1 (V1): At discharge from hospital; Visit 2 (V2): 3 months after discharge; Visit 3 (V3): 6 months after discharge; Visit 4 (V4): 12 months after discharge.

All participants have a temporary naso-duodenal tube used initially with the infusion pump to determine if the participant responds favorably to this method of treatment and to optimize the dose of Duodopa before permanent treatment is started.

Participants who choose a treatment other than Duodopa after the temporary naso-duodenal test phase are considered for the Standard of Care group. Participants who go on to select Apomorphine pump or Deep Brain Stimulation at any stage are not eligible to continue in this group or to continue in the observational period of study.

Participants who continue to with Duodopa treatment after the the temporary naso-duodenal test phase are the Duodopa group.

Eligibility Criteria:
Inclusion Criteria:

* Has advanced levodopa-responsive Parkinson's disease
* The decision to treat with Duodopa is made by the physician in accordance with the local label (Summary of Product Characteristics; product label) prior to any decision to approach the patient to participate in this study
* Parkinson's Disease (PD) medicinal treatment is unchanged for at least four weeks prior to baseline
* Takes oral medication four or more times daily
* Either has 2-4 hours of "off" time or 2 hours of non-troublesome or troublesome dyskinesia daily supported by a Unified Parkinson's Disease Rating Scale (UPDRS) Total Score in the best "on" state of at least 40 points at baseline; based on documented medical history

Exclusion Criteria:

* Use of Deep Brain Stimulation (DBS), Apomorphine pump or Duodopa treatment prior to baseline visit
* Severe dementia based on a Mini-Mental State Examination (MMSE) of \< 24
Health Promotion for Women With Fibromyalgia

Women with chronic disabling conditions such as fibromyalgia syndrome (FMS) must manage a wide variety of disease-related, intrapersonal, and environmental demands to maintain their health and quality of life. Engaging in health-promoting behaviors is one strategy recommended to manage disease symptoms and enhance quality of life (USDHHS, 2000). The purpose of this four-year study is to refine and test a theoretically and empirically based intervention to promote the health and well being of women with the chronic disabling condition of fibromyalgia. We hypothesize that women who participate in the "Lifestyle Counts" Intervention will report more greater self-efficacy for health behaviors, more frequent health behaviors and more positive health and quality of life than women in the comparison group.

This wellness intervention, originally developed and tested in a randomized clinical trial of women with MS (N=113), resulted in significant improvements in self-efficacy, health behaviors and improvements in pain, social functioning, mental health and emotional role-functioning. The specific aims of this study are to examine the effects of the adapted wellness intervention on self-efficacy, resources, barriers, health behaviors and health outcomes for women with fibromyalgia.

A sample of 160 women with FMS will be recruited to participate in a randomized clinical study to determine the effects of this wellness intervention that includes an eight week health promotion/behavior change component and 3 months of follow-up phone support. Content regarding stress management, lifestyle adjustment, physical activity, nutrition and women's health issues will be presented with an emphasis on the unique adaptations and associated skills required to empower women with the tools for exercising personal control over their health behaviors. The effects of the intervention on outcome variables will be assessed over an 8-month period with measurements at baseline, 2 months (immediately after the educational/skill-building component), 5 months (after 3 months of phone support) and at 8 months.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Physician verified diagnosis of Fibromyalgia for at least 6 months, age 18 to 75,
* Able to speak and read English
* Willing to participate in 8-month intervention study

Exclusion Criteria:

* Pregnancy
* Male
* Concurrent medical conditions (as judged by their physician) for which changes in diet and exercise would be contraindicated
OLIF25™ /OLIF51™ Study

The purpose of this single-arm observational study is to observe and document clinical outcomes of the OLIF25™ and OLIF51™ procedures in patients diagnosed with degenerative disc disease or degenerative scoliosis, and report the rate of adverse events of interest through the 24 months follow-up visit.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is 18 years of age or older.
2. Patient agrees to participate in the study and is able to sign the informed consent/data release form.
3. Patient is undergoing surgery from L2-L5 for OLIF25™ and/or from L5-S1 for OLIF51™ for degenerative disc disease or degenerative scoliosis.

Exclusion Criteria:

1. Illiterate or vulnerable patients (e.g. minors, participants incapable of judgment).
DNA Methylation for Screening Uterine Cervical Lesions: A Case-control Study

The primary objective of this study is to compare the testing of DNA methylation, high-risk HPV subtypes, and cytology with the definite histological results in a case-control study, so as to determine the accuracy of DNA methylation in the screening of uterine cervical lesions.

This study will include 300 patients with definite histological results, with 100 of cervical inflammation or low grade squamous intraepithelial lesions (LSIL), 100 of high grade squamous intraepithelial lesions (HSIL), and 100 of uterine cervical cancer. All the cervical specimens of cytology collected in the clinical settings will be utilized for the testing of DNA methylation, high-risk HPV subtypes and thin prep liquid-based cytology test (TCT). The sensitivity, specificity, positive predictive value and negative predictive value were calculated based on the known histological results. The differences of DNA methylation with high-risk human papillomavirus (HPV) and TCT will also be analyzed.

The testing of DNA methylation will be performed with the methylation-specific polymerase chain reaction (PCR). The TCT and HPV testing will be performed with the Roche kits.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed cervical histology within one month when collecting cervical cytology
* Aged 18 years or older
* Signed an approved informed consents

Exclusion Criteria:

* Not meeting any of the inclusion criteria
Prognosis of Atypical Pituitary Adenomas

Context: Pituitary adenoma is generally indolent, but an aggressive subtype called atypical adenoma has uncertain prognosis, and an unclear relationship between prognosis and morphology.

Objective: This study investigated the prognostic factors of this tumor. Design: Retrospective analysis. Setting: University and associated hospitals.


Eligibility Criteria:
Inclusion Criteria:

* pituitary adenomas of more than 3 % of Ki67 labeling index surgically treated at Tohoku university and associated hospital

Exclusion Criteria:

* pituitary adenomas of less than 3 % of Ki-67 labeling index surgically treated at Tohoku university and associated hospital
Predictive Diagnostic Criteria for Diagnosis of Transbronchial Biopsies, Echo-guided by Mini-probe in Peripheral Lung Lesions

The diagnosis of nodules and peripheral lung masses (lesions not accessible in classical bronchial endoscopy) is a challenge for the pulmonologist especially when these lesions are not accessible to the transparietal aspirate under scanner. The overall sensitivity of flexible fibroscopy for peripheral lesions is 69% (bronchial brushing, transbronchial biopsies, bronchoalveolar lavage and blind trans-mucosal aspiration). This sensitivity varies from 33% when the lesion is less than 2 cm, to 62% when it is greater than 2 cm. The puncture under scan of these lesions remains the gold standard. In the meta-analysis of Schreiber G et al., The diagnostic sensitivity of transparietal aspirate for peripheral lung lesions is 90%. On the other hand, the complication rate of this technique is not negligible, with in the study of Boskovic et al, a pneumothorax rate varying from 8 to 64%. In the literature, the only risk factor actually found is the existence of emphysema. However, thoracic drainage is rarely necessary.

Bronchial echo-endoscopy using a radial mini-probe was developed in 1992 by Thomas Hürter and Peter Hanrath to produce ultrasound guided specimens of these peripheral lung lesions. In the meta-analysis of Steinfort et al., The overall sensitivity of this mini-probe technique is 73% for the histological diagnosis. From the same author, a randomized trial compared the diagnostic sensitivity of transparietal aspirate undergoing ultrasound-guided transbronchial biopsy with a radial mini-probe: this was 93.3% versus 87.5% with no significant difference (p = 1 ), Whereas post-procedure complications are less frequent in the ultrasound procedure (27% versus 3%, p = 0.03). Steinfort also showed that the economic cost of bronchial echo-endoscopy by radial mini-probe and transthoracic puncture under CT was similar both to the success or failure of the first procedure requiring further investigations . Mini-probe-guided specimens are therefore an efficient diagnostic alternative to obtain a histological diagnosis of these peripheral lung lesions


Eligibility Criteria:
Inclusion Criteria:

* All patients who underwent mini-probe fibroscopy at Amiens University Hospital from January 2013 to March 2016

Exclusion Criteria:

* No
Effectiveness of Nutrition Education in Carbohydrate Counting in People With Type 1 Diabetic

Carbohydrates are the nutrient in the diet with the greatest impact on blood glucose. Inadequate carbohydrate counts are associated with higher A1c and greater variations in postprandial blood glucose. Clinical guidelines for the nutritional treatment of diabetes recommend that patients with DM1 learn carbohydrate counting or some similar systematic strategy that allows for better metabolic control. However, despite the recommendations, this is still not a reality for most healthcare services treating individuals diagnosed with DM1.

The study aims to assess the impact of a structured nutrition education programme for nutritional education and carbohydrate counting, in group sessions, on glycemic control and nutritional literacy in people with DM1. This will be achieved by evaluating the glycaemic control through A1c and daily glycaemic variability (time on target, mean glycaemia), as well as the level of knowledge before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥18 years old who have been diagnosed with type 1 diabetes or parents of children and adolescents (\< 18 years old) who have been diagnosed with type 1 diabetes;
* To be under intensive insulin therapy (basal/bolus system);
* To regularly use a continuous glucose monitoring system as primary method for glycaemic control;
* To be able to read and write.

Exclusion Criteria:

* None
Clinical Trial to Evaluate the Model SC9 IOL Compared to the Model LI61SE IOL (Bausch & Lomb)

To evaluate the Model SC9 Intraocular Lens for the improvement of near and intermediate vision when compared to a legally marketed monofocal IOL.

Subjects will be randomized to one of two groups. Group A, (Test Lens, Model SC9) or Group B, (Control Lens, Model LI61SE, Bausch and Lomb).

Both groups will be randomized to receive either unilateral or bilateral implantation. No bilateral implantation is allowed in Phase 1. (50 subjects).

Subjects will be followed for 36 Months.

Eligibility Criteria:
Inclusion Criteria:

* Twenty-two years or older at the time of surgery and diagnosed with bilateral cataracts
* Able to comprehend and sign a statement of informed consent
* Willing and able to complete all required postoperative visits
* Calculated Lens Power within the available range for the study IOL's
* Planned cataract removal by phacoemulsification
* Potential postoperative visual acuity of BCDVA 0.2 LogMAR (20/32) or better in both eyes
* Subjects with less than 1.0D of corneal astigmatism
* Clear intraocular media other than cataract in the study eye
* Preoperative BCDVA worse than 0.2 LogMar (20/32) with or without glare
* Pupil size greater or equal to 6.0mm after dilation

Exclusion Criteria:

* Any corneal abnormality, other than regular corneal astigmatism
* Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level worse than 0.2 LogMAR (20/32)
* Previous refractive surgery
* Amblyopia
* Clinical severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy)
* Diabetic retinopathy
* Extremely shallow anterior chamber, not due to swollen cataract
* Microphthalmos
* Previous retinal detachment
* Previous corneal surgery
* Recurrent severe anterior or posterior segment inflammation of unknown etiology
* Rubella or traumatic cataract
* Iris Neovascularization
* Glaucoma (uncontrolled or controlled with medication)
* Aniridia
* Optic nerve atrophy
* Damaged incomplete zonules
* Systemic disease that could increase the operative risk or confound the outcome
* Medications that, in the opinion of the investigator may confound the outcome or increase the risk to the subject (tamsulosin hydrochloride (Flomax) or other medications with similar side-effects (floppy iris syndrome)