cyrilzakka/clinical-trials huggingface dataset:
Best Biliary Drainage Option in Advanced Klatskin Tumor

To investigate the biliary drainage-related cholangitis and other complications of percutaneous transhepatic biliary drainage (PTBD) in the management of Klatskin tumor (KT) compared with endoscopic biliary drainage (EBD).

Operative treatment combined with preoperative biliary drainage (PBD) has been established as a safe management strategy for KT. Preoperative cholangitis was an independent risk factor for patients undergoing resection for KT. However, controversy exists regarding the preferred technique for PBD.

Eligibility Criteria:
Inclusion Criteria:

* Type II、III、IV Klatskin tumor patients;
* 18-90 years old

Exclusion Criteria:

* Unwillingness or inability to consent for the study;
* Coagulation dysfunction (INR\> 1.3) and low peripheral blood platelet count(\<50×109 / L) or using anti-coagulation drugs;
* Previous endoscopic sphincterectomy (EST) or endoscopic papillary balloon dilatation (EPBD);
* Any type of GI reconstruction;
* Combined with Mirizzi syndrome and intrahepatic bile duct stones;
* Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage, severe liver disease, primary sclerosing cholangitis (PSC), septic shock;
* Biliary-duodenal fistula;
* Pregnant women
Seizure Prophylaxis With Levetiracetam in Aneurysmal Subarachnoid Hemorrhage - Pilot Study

The purpose of this study is to determine the feasibility of prospectively enrolling and randomizing patients with aneurysmal subarachnoid hemorrhage (aSAH) to receive levetiracetam or not to receive levetiracetam, and documenting in-hospital and follow-up clinical variables.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* ≤ 75 years of age
* Newly diagnosed aneurysmal subarachnoid hemorrhage

Exclusion Criteria:

* One or more antiepileptic medication is taken as a pre-admission medication
* Seizure occurrence in the field or in the emergency department, or anytime before consent could be obtained
* Inability to obtain informed consent from the patient, or from the patient's appropriate surrogate
EVITA: Evaluation of VIP Feature in Pacemaker Patients

The primary efficacy objective of this clinical investigation is to demonstrate that the Ventricular Intrinsic Preference (VIP™) feature allows to reduce the medium- and long-term incidence of unnecessary ventricular pacing in patients with intact AV conduction.


Eligibility Criteria:
Inclusion Criteria:

* Patient has an indication for implantation of a dual-chamber pacemaker;
* Patient is implanted or scheduled to be implanted with a St Jude Medical Victory pacemaker, or newer device with the same study relevant feature.

Exclusion Criteria:

* Patient has persistent or permanent AF/AFl;
* Patient has permanent AV Block;
* Patient has a pacemaker replacement;
* Patient is in NYHA class IV;
* Patient is unable to attend the follow-up visits;
* Patient is pregnant;
* Patient is less than 18 years of age
Pilot Study-Quantitative Analysis of Positional Fatty Acids in Postprandial Chylomicron Triacylglycerol Using 13C NMR Spectroscopy

13C NMR spectroscopy has been validated to be a rapid, direct and accurate quantitative method in determination of positional distribution of fatty acids in edible oils and fats, including the palm oil fractions (from soft olein to hard stearin). Nevertheless, there is paucity of literature describing its application in determining the positional fatty acid composition in blood triacylglycerols \& biological samples, despite its widely used application in edible oils and fats. The postprandial feeding intervention is aimed to harvest chylomicron rich in triglycerides (\~97% TAG) for NMR analysis.

A pilot postprandial study with double blind, 2x2 arms randomized crossover experimental design will be carried out. A total of 10 subjects (5 males, 5 females) will be recruited and divided into 2 groups. Each group will be assigned to one of the test fat and fed with test meal prepared with 50g of test fats. 10 mL of blood samples will be collected at time points 0 (baseline, before meal) and 3, 4 and 5h after finish the meal. There shall be a 2-weeks washout period between each test fat.

Test fats used for this study are palm olein, with predominantly oleic acid at sn-2 position of the triglyceride backbone (about 68%, Gunstone et al, 2007) and lard, with predominantly palmitic acid at sn-2 position (about 72%, Gunstone et al., 2007). A high fat muffin with 50g of test fat will be formulated using the above two test fats mentioned. On each study day, a high fat muffin will be served and a glass of skim milk will be provided for subjects to help the digestion of fats from the muffins.

Chylomicron will be harvested using the ultracentrifugation technique. Samples collected will be stored in -80°C prior to NMR analysis.

Eligibility Criteria:
Inclusion Criteria:

* Non muslim, aged between 25 - 40 yrs old.
* BMI between 20 - 27.5 kg/m2.
* Blood pressure with \<130mmHg for systolic pressure and \< 80 mmHg for diastolic pressure.
* Blood glucose level in the range of 3.9 to 5.5 mmol/L.
* Total cholesterol level \< 6.0 mmol/L.
* Triglycerides level \< 2.3 mmol/L.
* No use of tobacco and no consumption of alcohol.

Exclusion Criteria:

* Suffer from chronic disease such as CVD, hypertension, diabetic, metabolic syndrome.
* Consuming any medical prescriptions/ supplements.
* Having blood clotting problem.
* Women who are pregnant or lactating.
* Hypertensive condition with systolic pressure \>140mmHg and diastolic pressure \> 90 mmHg.
Ernährungs-Interventions-Fettleber-Studie (Interventional Study on Nutritional Effects on NAFLD)

Epidemiological data and studies in animal models suggest, that polyunsatured fatty acids (PUFA) rather than mono-unsatured fatty acids (MUFA) are associated with lower hepatic lipid content (HCL) and may facilitate a decrease of HCL in case of non-alcoholic fatty liver disease (NAFLD).

The investigators therefore conduct an interventional trial in subjects with normal glucose metabolism, but increased HCL, fulfilling criteria for NAFLD.

The study will compare two dietary interventions in parallel design, one containing mainly PUFA (canola oil), one containing only MUFA (olive oil). The intervention of 8 weeks is accomodated by dietary counseling. Metabolic outcome variables will be assessed with MR spectroscopy (liver fat) and euglycemic hepatic clamp (glucose metabolism/insulin sensitivity).

Epidemiological data and studies in animal models suggest, that polyunsatured fatty acids (PUFA) rather than mono-unsatured fatty acids (MUFA) are associated with lower hepatic lipid content (HCL) and may facilitate a decrease of HCL in case of non-alcoholic fatty liver disease (NAFLD). A typical source for PUFAs are fish and certain plant oils, a source of almost pure MUFAs is olive oil.

The investigators therefore conduct an interventional trial in subjects with normal glucose metabolism, but increased HCL, fulfilling criteria for NAFLD. The investigation focusses on male participants to avoid sex-related differences in the results.

The study will compare two isocaloric dietary interventions in parallel design, one containing mainly PUFA (canola oil), one containing only MUFA (olive oil). The intervention of 8 weeks is accomodated by dietary counseling (4 sessions). Metabolic outcome variables will be assessed with MR spectroscopy (liver fat), anthropometry (to check for stable weight and body composition) and euglycemic hepatic clamp (glucose metabolism/insulin sensitivity).

Eligibility Criteria:
Inclusion Criteria:

* increased hepatic fat content (NAFLD)
* BMI between 30 and 35 kg/m²

Exclusion Criteria:

* diabetes
* severe cardiac, pulmonary or gastrointestinal disorders
* hepatic disorders other than NAFLD
* alcoholism
* medication with metabolic side or main effects (e.g. statins)
Long-term Comparative Analysis of Visual Outcomes With 3 Intraocular Lenses: Monofocal, Trifocal and Accommodating

To compare visual outcomes, contrast sensitivity, glare occurrence, incidence of posterior capsule opacification (PCO) and subjective satisfaction in patients implanted with trifocal, accommodating and monofocal lens in long term period.

The goal of cataract surgery is to remove lens opacity and restore vision. Nowadays most of the patients wanted to be spectacle independent. The desire of visual acuity for all distances increases the popularity of multifocal and trifocal lenses. As these type of lenses are mostly based on diffractive structure, there could be occurrence of unwanted optical phenomena and lower contrast sensitivity. The effort is to produce intraocular lens (IOL) with good vision for all distances without these unwanted effects. Increasing daily task for intermediate distance led to the new category of IOLs- EDOF( extended depth of focus) IOLS, which are based mostly on diffractive profiles too, but should have less optical phenomena occurrence. To completely remove glare, halo and retain standard good contrast sensitivity enhance monofocal lenses were invented, mostly based on spherical aberrations, but not achieving as good intermediate vision as multifocal or EDOF lenses do. Accommodating lenses should provide better intermediate distance without unwanted optical effects on vision.

This study is retro-prospective, comparing 3 different lenses in long-term period. First group includes patients with trifocal lens allowing patients to see for all distances, second group includes patients with implanted accommodating lens which allows good distance and better intermediate distance than monofocal. Third group include patients with standard monofocal lens. Preoperative data were collected retrospectively and one prospective visit was scheduled in period 36- 48 months after the surgery. Study is conducted in 2 eye centers- one in Slovakia Trenčín, one in Prague, Czech Republic. The study was approved by the Ethic committee of faculty hospital Hradec Kralove (202103 P08). and will enrolled up 40 patients in each category.

Eligibility Criteria:
Inclusion Criteria:

* phacoemulsification with one of the 3 types of lens implantation before 36 to 48months
* no other ocular pathology affecting visual acuity
* able to maintain follow up visit

Exclusion Criteria:

* corneal opacities or irregularities
* amblyopia
* glaucoma with change in visual fields
* any other type of ocular surgery than phacoemulsification with primary lens implantation
To Study the Effect of β-glucans on Wound Healing

The purpose of this study is to determine the effect of β-glucans on wound healing.

The structure of βeta-glucan (β-glucans) is a pathogen associated molecular patterns (pathogen-associated molecular patterns, PAMPs), widely present in the cell walls of plants, bacteria, yeasts, fungi, mushrooms and algae. Modern has been reported in the literature that β-glucan can enhance the immune system of animals, and to enhance the function of the animal against bacterial, fungal and viral infections, and cancer.In this study, the use of β-glucan to enhance the biological characteristics of the non-specific immunity, to explore the impact of postoperative patients with wound healing and infection rates.The observation of the healing process to take the Leather District wounds (5 \~ 200 cm2). The experiments were carried out for 18 months, were observed record the following three: (1) the rate of wound healing, (2) The rate of infection assessment: record length of time and the point in time at all levels of antibiotic use also observe the wound change (redness, swelling, heat, pain).(3) days of hospitalization, and spend statistics. Using unpaired student's t-test analysis, group data whether the differences between groups of experimental data. represents a statistically significant when p \<0.05.

Eligibility Criteria:
Inclusion Criteria:

1. Total burn area under 20%, two to three degree burn and need skin-grafting.
2. Subjects don't have other diseases.
3. Subjects' age between 20 to 60.

Exclusion Criteria:

1. Subjects with hypersensitivity.
2. Subjects with Autoimmune disease.
Assessing the Occupation Burden in COPD

To assess the population burden of occupational exposures in the prevalence and progression of chronic obstructive pulmonary disease (COPD).

BACKGROUND:

Chronic obstructive pulmonary disease is the only one of the top four or five leading causes of death in the U.S. with worsening epidemiological trends. Cigarette smoking accounts for approximately 85 percent-90 percent of cases, but the other 10 percent-15 percent of the attributable risk still represents a substantial fraction of this disease that remains unexplained. Recently, several studies, in various countries, have addressed whether certain occupational exposures (primarily those relating to dusts, vapors, gases, and/or fumes) are potential risk factors for COPD. Most of these studies have shown elevated odds ratios or relative risks, although not always to a statistically significant level.

DESIGN NARRATIVE:

A population sample of the continental United States of those aged 55-75, supplemented by an enriched sample in geographic "hot spots" identified by the National Institute for Occupational Safety and Health (NIOSH) through respiratory diseases mapping. Structured telephone interviews assessed demographics, health status, smoking exposures, and occupational histories. High risk jobs were coded using a job matrix system independent of subject report of specific exposures. Two hundred thirty-four of those with COPD, with over-sampling of those with greater severity, were followed at 12-14 months to assess health status and health services utilization, as well as decrements in quality of life.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Genetic Polymorphysm of Cholesterol 24 S Hydroxylase in Patients With Glaucoma and AMD

The aim of this study is to assess the implicitement of the cholesterol 24 S hydroxylase gene and the 24 S hydroxycholesterol in glaucoma and in age related macular degeneration.


Eligibility Criteria:
Inclusion Criteria:

* Patient with Glaucoma
* Patient with AMD
* Healthy patient

Exclusion Criteria:

* All patients who use any treatment in order to maintain in normal value their blood cholesterol
The Effect of Coenzyme Q10 on Endothelial, Vascular and Myocardial Function

Non-alcoholic fatty liver disease (NAFLD) is associated with increased cardiovascular risk. The aim of this study is to investigate the effects of coenzyme Q10 (CoQ10) on endothelial, vascular and myocardial function in patients with NAFLD

Non-alcoholic fatty liver disease (NAFLD) is associated with increased cardiovascular risk. The aim of this study is to investigate the effects of coenzyme Q10 (CoQ10) on endothelial, vascular and myocardial function in patients with NAFLD. In this trial patients with NAFLD will receive 240mg Q10 or placebo. At baseline and at 6 months, will be measured: a) Perfused boundary region (PBR) of the sublingual vessels using the SideviewDarkfieldimaging technique (Microscan, Glycocheck), b) pulse wave velocity (PWV-Complior, ALAM), c) flow-mediated dilation (FMD) of the brachial artery, d) left ventricular (LV) global longitudinal strain (GLS), and e) controlled attenuation parameter (CAP)for the quantification of liver steatosis by liver elastography (Fibroscan, Echosens).

Eligibility Criteria:
Inclusion Criteria:

* NAFLD AND one of below :

  1. dyslipidemia, as it is defined in the metabolic syndrome
  2. increased waist circumference as defined in the metabolic syndrome
  3. Arterial hypertension,
  4. overweight, (BMI\>25)
  5. polycystic ovary syndrome,

Exclusion Criteria:

* Chronic Kidney Disease
* Heart Failure
* Liver failure
* Pregnancy/ Breast feeding
* Active malignancy (receiving Chemotherapy/immunotherapy)
The Effects of Cosmetic Care on Body Image in Young Chinese Breast Cancer Patients Receiving Chemotherapy

This study aimed to explore the effects of cosmetic care on body image (BI), and social avoidance and distress (SAD) in young Chinese breast cancer patients, aged 18-40 years old, receiving adjuvant chemotherapy. This was a single-center, 2-arm quasi-experimental study. The control group received usual care, while cosmetic care was added to the intervention group. The primary outcomes were BI and SAD accompanying chemotherapy, and the secondary outcome was the appearance satisfaction.

Background: The diagnosis and treatment of breast cancer may still bring severe psychological trauma to women. Cosmetic care is an effective measure to enhance patients' psychosocial functioning, which can help cancer patients cope with disfigurement-related adverse effects.

Objectives: This study aimed to explore the effects of cosmetic care on body image (BI), and social avoidance and distress (SAD) in young Chinese breast cancer patients, aged 18-40 years old, receiving adjuvant chemotherapy.

Study design: This was a prospective, 2-arm quasi-experimental study, comprising two groups: the controlled group and the interventional group. In order to avoid interference, the two groups of participants were recruited at different periods. The control group was recruited from Jan 2015 to Mar 2015, and the intervention group was recruited from January 2016 to September 2017. All participants came from the department of a breast surgery in Shanghai, China.

Control condition: Participants in the control group received usual care during adjuvant chemotherapy.

Intervention: Participants in the intervention group received cosmetic care in combination with usual care.

Ethical approval: Ethical approval of this study was obtained from the ethical committee of a cancer center in Shanghai. The approval number was 1403132-2. Informed consent was explained to the participants and the forms were signed by them.

Data analyses: The IBM SPSS 22.0 was used to analyze all the data.

Eligibility Criteria:
Inclusion Criteria:

* Primary breast cancer patients
* Aged 18-40 years old, who received surgery and adjuvant chemotherapy in our department
* No prior neoadjuvant chemotherapy
* Being available to communicate by the novel social application "Wechat"

Exclusion Criteria:

* Diagnosis of psychiatric or intellectual impairment
* Having a history of neoadjuvant therapy
* Having distant metastasis
* ECOG\<2
Role of Psychoanalysis in Prevention of Girl Child Maltreatment and Neglect

In India, precisely northern states, skewed sex ratios, female feticide and higher child mortality rates for girls have become serious concern. The female child mortality as a result of son preference have increased during the last several decades .Since families cannot know the sex of the fetus due to Indian government policies, maltreatment and serious neglect has been tools to ensure there are few survivors.


Eligibility Criteria:
Inclusion Criteria:

* Families having girl child before
* High risk families with high expectation of having son

Exclusion Criteria:

* Families having son before
* Relocation and moving out of town during study period
* Not ready to consent for intervention
Comparing Anastrozole-Placebo to the Combination Anastrozole-ZD1839 in Postmenopausal Patients With Estrogen Receptor and/or Progesterone Receptor Metastatic Breast Cancer

This study is being carried out to see if treatment with ZD1839 (Gefitinib) combined with Arimidex (Anastrozole) has improved efficacy over Arimidex alone in preventing progression of metastatic breast cancer.

This is a phase II, multicenter, double-blind, randomized, placebo-controlled trial. Patients will be randomized in a double-blind manner in a 1:1 ratio to receive either 250 mg/day ZD1839 or matched placebo in combination with 1 mg/day anastrozole. The dose of ZD1839 has been selected based on clinical studies in other tumor types suggesting identical efficacy together with a better toxicity profile in patients treated at 250 mg compared to 500 mg/day. The 1 mg dose of anastrozole is the standard approved dose.

Eligibility Criteria:
Inclusion Criteria:

* Female postmenopausal patients aged 18 years or older with newly diagnosed metastatic breast cancer.
* Patients with recurrent disease during or after adjuvant tamoxifen or patients who are hormone therapy naïve are eligible for this trial.
* A paraffin embedded tumor tissue block or slides from either the metastatic or primary tumor site is required.

Exclusion Criteria:

* Patients cannot be on hormone replacement therapy while on study.
* Prior chemotherapy received for metastatic disease is not allowed.
* Previous treatment with tyrosine kinase inhibitors or aromatase inhibitors is not allowed.
* Patients who have evidence of an active interstitial lung disease are not eligible.
Comparison of the Effects of Nasal Steroids and Montelukast on Olfactory Functions in Patients With Allergic Rhinitis

The investigators aimed to evaluate by the Sniffin' Sticks test the effects on olfactory functions of nasal steroids and leukotriene antagonists used for allergic rhinitis.Thirty patients with seasonal were included in this study. Patients were randomly divided into three groups of 10 patients; group 1 received montelukast sodium and mometasone furoate therapy, group 2 received only montelukast, and group 3 only mometasone furoate. Patients' olfactory functions were determined using the Sniffin' Sticks olfactory test before and after a month treatments.

Threshold, discrimination, identification, and TDI values were not significantly different among the groups before treatment. For Group 1 and Group 3 patients, there were statistically significant differences in threshold, discrimination, identification, and TDI values before and after treatment (p \< 0.05) (Wilcoxon signed ranks analysis) For Group 2 patients, the before and after treatment values of threshold, discrimination, identification, and TDI showed no significant differences (p \> 0.05). According to the findings of our study, MF is superior to montelukast in improving olfactory function. Although montelukast has been shown to be effective against AR symptoms, its effect on olfactory function was not demonstrated in this study.


Eligibility Criteria:
Inclusion Criteria:

* Positive skin test to grass and/or tree pollens in patients with clinical history of seasonal AR for at least 1 year

Exclusion Criteria:

* Patients who had received drug treatment or immunotherapy before the study were excluded.
* Patients with asthma, deviated nasal septum, history of nasal operation, turbinate hypertrophy, nasal polyposis or chronic nasal disorders, pregnancy, or upper airway infections were also excluded.