cyrilzakka/clinical-trials huggingface dataset:
Association of BsmI Polymorphisms in Vitamin D Receptor Gene With Diabetic Kidney Disease

Background: Diabetic kidney disease (DKD), as one of chronic complication of type 2 diabetes mellitus, is common cause of end stage renal disease (ESRD). Vitamin D deficiency is known as one of DKD risk factors. Recent studies on association between vitamin D deficiency and DKD had shown conflicting results. It may be due to vitamin D receptor gene polymorphisms, which is affected by BsmI, Cdx2, ApaI, FokI, and TaqI gene. The investigators conducted cross-sectional study to investigate association between BsmI polymorphisms in vitamin D receptor gene with diabetic kidney disease

Hypothesis: BsmI polymorphisms in vitamin D receptor gene is associated with diabetic kidney disease (DKD)

Diabetic kidney disease (DKD) is a common cause of end stage renal disease (ESRD). Data from Indonesian Renal Registry (2011) revealed that 25% etiology of patients who underwent hemodialysis is DKD. Risk factors that are associated with DKD include blood glucose control, hypertension, dyslipidemia, duration of diabetes mellitus, high body mass index (BMI), age, sex, ethnicity, vitamin D deficiency, high sodium diet, high protein diet, and smoking.

The roles of vitamin D that are related to kidney are inhibition of renin transcription process, angiotensin II, renal inflammation process, and albumin excretion, prevention of podocytes damage, glomerulosclerosis process, and transformation from kidney epithelial cell into mesenchymal cell. Current studies on association between vitamin D deficiency and DKD had shown conflicting results. It may be related to genetic factor which is vitamin D receptor polymorphisms. The vitamin D receptor polymorphism is affected by Cdx2, ApaI, BsmI, FokI, and TaqI gene, where Asian population is mostly affected by ApaI, FokI, and Cdx2.

Several studies had reported the association between BsmI polymorphisms in vitamin D receptor gene and DKD in various population. Zhang, et al (2012) study revealed the association between BsmI polymorphisms in vitamin D receptor gene and DKD in Han Chinese population, while study from Vedralova, et al (2012) in Caucasian race showed opposite result. However, the association between BsmI polymorphism in vitamin D receptor gene and DKD has not been investigated in Indonesian-Malay race.

This is a cross-sectional study that investigate the association between BsmI polymorphisms in vitamin D receptor gene and DKD in Indonesian-Malay race. The investigators collected data about study participants' characteristics, conducted physical examination and laboratory examination, which include BsmI polymorphisms in vitamin D receptor gene.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus patient
* Indonesian-Malay race
* Had signed the informed consent

Exclusion Criteria:

* Urinary tract infection
* Pregnant patient
* Fever
* In menstrual period
* Had undergone hemodialysis or peritoneal dialysis
* Had used non steroid antiinflammatory drugs (NSAIDs)
* Postexercise
Oral Dietary Fucoxanthin Rich Supplement for Liver Health

Blind, placebo-controlled study testing the hypothesis that oral dietary supplement rich with fucoxanthin will decrease biochemical clinical markers related to liver health.

Six month supplementation

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults \> 18 years
* Willing to sign an informed consent to participate in the study.
* Non-smokers.
* Blood results above the normal range in hepatic function testing consisting of panels containing ALT, AST, ALP, total bilirubin and albumin and abdominal ultrasonography.
* Over-weight (BMI ≥ 27 kg/m2) who fulfill the criteria of the National Cholesterol Education Program (NCEP) metabolic syndrome.

Exclusion Criteria:

* Pregnancy.
* Presence of gastrointestinal or mental disorders, diabetes mellitus, alcohol abuse, weight-loss treatment, bariatric surgery, unusual diets (vegetarian, vegan), daily usage of antioxidants dietary supplements at the last 4 months (for subjects in stage 2 of the study).
* Serious medical conditions.
A Prospective Phase II Study for Adjuvant Hypofractionated Intensity-modulated Proton Radiotherapy for Post Operative Breast Cancer With Implantation Reconstruction

The incidence of breast reconstruction failure after conventional photon radiotherapy for breast cancer is about 18.7%. At present, there is limited data on proton radiotherapy for post operative breast cancer with implantation reconstruction. Proton radiotherapy for breast cancer can significantly reduce the radiation dose of the ipsilateral heart and lung, thereby reducing the incidence of cardiac events and radiation pneumonia. This study is aimed at the study of adjuvant hypofractionated intensity-modulated proton radiotherapy for post operative breast cancer with implantation reconstruction. It can provide an ideal treatment option for such patients to effectively protect the heart and lungs without increasing the failure rate of breast reconstruction after adjuvant radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* 1: Patients with pathologically confirmed breast cancer

  2: Indications: patients who need adjuvant radiotherapy after mastectomy and implant reconstruction

  3: No distant metastasis

  4: Had no chest and breast radiotherapy history

  5: Between the ages of 18 and 80

  6: ECOG general status score is 0-2,There are no serious pulmonary hypertension, cardiovascular disease, peripheral vascular disease, serious chronic heart disease and other complications that may affect the radiotherapy

  7: Non pregnancy (confirmed by serum or urine β- HCG test) or lactating women

  8: The patient must sign the informed consent form for receiving radiotherapy.

Exclusion Criteria:

* 1: No pathological confirmation；

  2: Distant metastasis；

  3: Had chest and breast radiotherapy history

  4: Organs at risk could not achieve safe dose

  5: Pregnancy (confirmed by serum or urine β- HCG test) or lactating women

  6: Poor general health status, i.e. KPS\<70, or ECOG\>2

  7: There are serious complications that may affect the radiotherapy, including: a) unstable angina, congestive heart failure and myocardial infarction requiring hospitalization in the past 6 months； b) Acute bacterial or systemic fungal infection；c) Chronic obstructive pulmonary disease exacerbation or other respiratory diseases need hospitalization； d) Patients with immunosuppression；e) With connective tissue disease, such as active scleroderma or lupus and other contraindications to radiotherapy；

  8: Unable to understand the purpose of treatment or unwilling/unable to sign informed consent.
Evaluation of the All-on-three Concept in Mandible.

Evaluation of the clinical and radiographic treatment outcomes of immediately loaded three implants by fixed-detachable prostheses for the management of totally edentulous mandibles.

The hypothesis is that mandibular immediately loaded fixed detachable restorations supported only by three implants in the inter-foraminal region will not adversely affect the clinical or radiographical treatment outcome.

The ideal amount of implants for edentulous mandible rehabilitation continues to be a subject of scholarly debate. Traditionally, at least four implants are required for fixed detachable prostheses, but increasing implant numbers raises costs and complexity, leading to patient reluctance. Reducing the number to three implants may simplify surgery, minimize trauma, and encourage patient acceptance.

Eligibility Criteria:
Inclusion Criteria:

* Completely edentulous patients with skeletal Class I maxilla-mandibular relationship.
* Adequate inter-arch space (22 mm), measured using the "try in" before any intervention.
* Male or female patients aged between 40 and 60 years.
* Maxillary and mandibular ridges with no history of recent extraction.
* Mandibular ridge should be ≥15 mm in height and ≥7 mm in width to accommodate three implants in the intra-foramina area of the mandibular arch, verified by using cone beam computed tomography (CBCT).

Exclusion Criteria:

* History of radiotherapy in the head and neck region.
* History of hard tissue augmentation.
* Presence of any intra-oral pathological condition.
* Any medical disorder that could complicate the surgical phase or affect osseointegration, such as osteoporosis, uncontrolled diabetes, and hypertension.
* Smoker and bruxer patients.
Preliminary Human Trial of NPI-028

This research will determine whether the Chinese herbal medicine (NPI-028) can make a significant contribution to the management of withdrawal and to follow-up treatment aimed at preventing or managing relapse in both women and men alcoholics. The herbal preparation has been used historically in the treatment of alcohol intoxication and is still prescribed in China and Southeast Asia. Efficacy has been documented but awaits the application of current research methods to establish efficacy, safety, and probable mechanisms of action. Preclinical studies have been carried out in alcohol-preferring rats and vervet monkeys to test efficacy in reducing voluntary alcohol intake, measure tolerance effects, and toxicological affects. The proposed human trial will develop a placebo, establish quality control, test methods of administration, and examine compliance issues. Following these preliminary steps, a placebo controlled trial will be conducted using 160 subjects (80 subjects per treatment condition with 40 of each gender). Alcohol use, craving, health status, psychological status, and at rates will be assessed using established measures that are current in addiction research.


Eligibility Criteria:
Inclusion Criteria:

* Able to participate as an outpatient
* Considered of acceptable health as determined by physical examination
* English speaking/reading
* Meets DSM-IV criteria for Alcohol Dependence
* Have at least 10 drinking days in the past month
Airway Ultrasound Prediction and Correlation

This is a novel approach to assess the use of ultrasound to support the identification of obstructive sleep apnea syndrome (OSAS) on a screening questionnaire, and potentially to predict a difficult pediatric airway. The investigators hope to determine if a combination of simple bedside clinical tests can be used to identify OSAS in patients who present for surgery with clinical signs of OSAS but without a formal polysomnography.


Eligibility Criteria:
Inclusion Criteria:

* All children presenting for surgery at NCH ranging in age from 3-12 years

Exclusion Criteria:

* Parent/ patient refusal to participate in study
Erectile Dysfunction in Good Prognosis Prostate Cancer : Comparison Between Brachytherapy and Stereotactic Body Radiotherapy

The TEMPOS-GEniToUrinary Group (GETUG) study is a multicenter, medico-economic study comparing brachytherapy to SBRT in low and intermediate risk prostate cancer, particularly focused on the issue of erectile dysfunction. A total of 240 potent patients are randomized in two arms. The experimental arm consists of SBRT delivering 7.25 Gy per fraction, in five fractions, corresponding to a total dose of 36.25 Gy to the prostate. The control arm consists of brachytherapy by Iodine 125 delivering 144 Gy to the prostate. The main objective of this health economics study is to perform a cost-utility analysis of SBRT compared to "standard" Iodine 125 brachytherapy in low-risk prostate cancer, 3 years after treatment. The endpoint is the Incremental Cost-Utility Ratio (ICUR) between SBRT and brachytherapy as primary criterion, expressed in cost per quality adjusted life year (QALY) gained. Cost-effectiveness analyses are performed as secondary objective with Incremental Cost-Effectiveness Ratios (ICERs) expressed as cost per erectile dysfunction avoided and cost per Life Year Gained. A long term evaluation is also performed, including a cost-utility, cost-effectiveness and budget impact analysis at 5 years, a comprehensive assessment of the erectile dysfunction up to 5 years after treatment, an evaluation of acute and late genito-urinary (GU) and Gastro-Intestinal (GI) toxicities, and of quality of life up to 5 years after treatment.

Eight patients/year/center are expected to be recruited in 2 years in about twenty participating centers.

In total, to our knowledge, this study will be the first health economic evaluation which compares SBRT versus Iodine 125 brachytherapy in low risk and intermediate risk prostate cancer. Both cost-utility and cost-effectiveness analyses will also provide useful and complementary information to decision makers in order (i) to recommend the best strategy to adopt; (ii) to estimate the budget impact on the French National Health Insurance of the generalization of the cost-effective strategy. Finally, this study will allow to assess and compare accurately the erectile dysfunction after both treatment modalities.


Eligibility Criteria:
Main inclusion criteria

* Biopsy proven prostate adenocarcinoma,
* Low risk prostate cancer according to d'Amico (T1-T2a and PSA \<10 ng/ml, and Gleason score 6) or intermediate risk prostate cancer according d'Amico but excluding tumor with Gleason score 7 (4 + 3),
* Indication of a curative treatment by brachytherapy validated in multidisciplinary consultation meeting,

Main exclusion criteria

* Androgen deprivation therapy,
* Contraindication for prostate Iodine 125 brachytherapy (Prostate volume \> 50 cc, impossibility if general anesthesia).
* Contraindication for Resonance Magnetic Imagery (RMI) (claustrophobia, pacemaker)
* Participation to another research which could have an impact on the study treatment and the outcomes
Combination Paclitaxel, Carboplatin and Temozolomide

The purpose of this study is to determine the maximum tolerable dose of temozolomide in combination with fixed dose of paclitaxel and carboplatin and to determine the overall tumor response rate with this combination and to determine the duration of response.

The objective of the research study is to test a combination of drugs to treat small cell lung cancer which has spread beyond the lungs (extensive cancer) or come back after earlier treatment (recurrent cancer).

Eligibility Criteria:
Inclusion Criteria:

1. Age greater than or equal to 18 years
2. Karnofsky performance status (KPS) of greater than or equal to 70 (Appendix B)
3. Laboratory values (performed within 14 days prior to study drug administration, inclusive).

   1. Absolute neutrophil count (ANC) \>1500/mm3
   2. Platelet count \>100,000/mm3
   3. Hemoglobin \>10 g/dl or 100 g/l
   4. BUN and serum creatinine \<1.5 times upper limit of laboratory normal
   5. Total and direct bilirubin \<1.5 times upper limit of laboratory normal
   6. SGOT and SGPT \<3 times upper limit of laboratory normal
   7. Alkaline Phosphatase \<3 times upper limit of laboratory normal
4. A life expectancy of greater than 12 weeks
5. Subjects must give written informed consent.
6. Biopsy proven small cell lung cancer.
7. CT of chest, abdomen, pelvis and MRI of head
8. Patients with brain metastases should be asymptomatic to enter the study

Exclusion Criteria:

1. No recovery from all active toxicities of prior therapies.
2. Subjects who are poor medical risks because of non-malignant systemic disease as well as those with acute infection treated with intravenous antibiotics.
3. Frequent vomiting or medical condition that could interfere with oral medication intake (eg, partial bowel obstruction).
4. Concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin. Prior malignancies which have not required anti-tumor treatment within the preceding 24 months are eligible.
5. Known HIV positivity or AIDS-related illness.
6. Pregnant or nursing women.
7. Women of childbearing potential who are not using an effective method of contraception. Women of childbearing potential must have a negative serum pregnancy test 24 hours prior to administration of study drug and be practicing medically approved contraceptive precautions.
8. Men who are not advised to use an effective method of contraception.
9. Progression of disease on prior chemotherapy with paclitaxel and carboplatin, either as single agent or in combination.
10. Known hypersensitivity reaction to taxoid or platinum compound.
A Study of the Safety and Efficacy of Vigam® Liquid in Patients With Primary or Secondary Antibody Deficiency

To determine:

1. The safety of Vigam® Liquid in patients with primary or secondary antibody deficiency (PAD or SAD).
2. The efficacy of Vigam® Liquid in patients with primary or secondary antibody deficiency.
3. The half-life of Vigam® Liquid after 4 months of treatment.
4. The subclass and total gammaglobulin concentrations after each infusion of Vigam® Liquid.


Eligibility Criteria:
Inclusion Criteria:

* Adults (18-80 years) with PAD or SAD
* With a low serum IgG (\<6 g/l) and a history of recurrent infections
* Requiring and eligible for polyvalent intravenous immunoglobulin (IVIG) replacement therapy
* Non-reactive for HBsAg and with an alanine aminotransferase (ALT) level less than twice upper limit of normal prior to entry into the trial

Exclusion Criteria:

-
Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels

International, multicentric, prospective, investigator-driven, open-label, randomized (1:1) clinical trial to observe and evaluate the efficacy, of Magic Touch Sirolimus Coated Balloon (SCB) compared to one of the gold standard treatment for native vessel disease (everolimus-eluting stent, EES).

The purpose of TRANSFORM II study is to observe and evaluate the efficacy of Magic Touch SCB compared to the gold standard treatment for native vessel disease, namely new-generation everolimus-eluting Drug Eluting Stent (DES). Given the inherent and recognized limitations of stents in native vessels with diameter \<3 mm, only patients with coronary vessels up to 3.5 mm of diameter (by visual estimation) will be enrolled in this study.

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years;
* all patients with a clinical indication to Percutaneous Coronary Intervention (PCI) (stable coronary artery disease or acute coronary syndromes);
* native coronary artery lesion in a vessel with diameter \>2.0 mm and ≦3.5 mm at visual estimation;
* maximum lesion length: 50 mm.
* informed consent to participate in the study.

Exclusion Criteria:

* patients with known (and untreatable) hypersensitivity or contraindication to aspirin, heparin, clopidogrel, prasugrel, ticagrelor, sirolimus or contrast media, which cannot be adequately pre-medicated;
* patients participating in another clinical study;
* subject is a woman who is pregnant or nursing (pregnancy test, either urine or blood test must be performed within 7 days prior to the index procedure in woman of child-bearing potential, and must not commit to initiating a pregnancy for 12 weeks after implantation, using effective contraception);
* creatinine clearance \<30 ml/min;
* left ventricular ejection fraction \<30%;
* life expectancy \<12 months;
* ST-elevation myocardial infarction in the previous 48 hours;
* visible thrombus at lesion site;
* culprit lesion stenosis \>99% and/or Thrombolysis In Myocardial Infarction (TIMI) flow \<2;
* target lesion/vessel with any of the following characteristics:
* concomitant PCI at the same vessel with any device (vessels are considered: left anterior descending, circumflex or right coronary artery);
* pre-dilatation of the target lesion not performed or not successful (residual stenosis \>30%);
* severe calcification of the target vessel, at lesion site but also proximally;
* highly tortuous vessel which could impair device delivery to the lesion site following Investigator's judgement;
* previous stent implantation at target vessel (left anterior descending artery; circumflex artery; right coronary artery);
* bifurcation lesion where side branch treatment is anticipated;
* left main stem stenosis \>50%;
* target lesion is in left main stem
* Lesion is located within asaphenous vein graft
ACP Simulation-based Communication Training Program for Nurses Discussing ACP With Chronic Kidney Disease Patients

This study was to evaluate the effects of ACP simulation-based communication training program (ACP-SCT program) for nurses to discuss ACP with chronic kidney disease patients

The ACP-SCT program was including three stages, as follows Stage I: To discuss ACP knowledge and law Objective: Opportunity to share experiences, and develop a mutual understanding of the the challenge of ACPdiscussing with CKD patients.

Stage II: communication skills section and Feedback section Objective: 1. To provide a structured approach to managing ACP discussions. 2. Opportunity to practice communication skills in a safe environment 3. Opportunity to discuss their experiences of the training program, and reflect future on their own practice and experience.

Eligibility Criteria:
Inclusion Criteria:

* Participants were nephrology nurses and worked at least one year

Exclusion Criteria:

* Non-nephrology nurses
Effect of EMST Systemic Inflammation and Oxidative Stress in Patients With Moderate OSAS

It was aimed to investigate the effect of expiratory muscle strength training (EMST) applied at different intensities on systemic inflammation and oxidative stress in patients with moderate obstructive sleep apnea syndrome (OSAS). In the study, 32 male patients diagnosed with moderate OSAS will be included in the study. Participants will then be divided into 2 groups by block randomization. In the three-blind planned study; the first group will receive high-intensity %60 maximum expiratory pressure (MEP) EMST training, and the second group will be given low-intensity 30% of MEP, EMST training for 12 weeks. Disease-related symptoms, disease severity apnea-hypopnea index (AHI), oxidative stress index (OSI) and systemic inflammation level, exercise capacity, respiratory muscle strength, sleep quality, daytime sleepiness, and fatigue severity will be evaluated before and after the study.

Primary outcome measures are; disease severity, oxidative stress index and systemic inflammation.

Secondary outcome measurements are; disease-related symptoms, exercise capacity, respiratory muscle strength, sleep quality, daytime sleepiness, and severity of fatigue.

Eligibility Criteria:
Inclusion Criteria:

1. Male patients diagnosed with moderate OSAS by polysomnography in the Sleep Center of Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital,
2. Those who are between 19-60 years old,
3. Stable general health status,
4. Volunteer to participate in the research,
5. Not using NIMV device,

5) Patients who do not have a mental problem that will prevent cooperation will be included.

Exclusion Criteria:

1. Female gender,
2. Having a previous stroke,
3. Having an overlap syndrome,
4. Having any neurological, psychological or cardiac disease,
5. Uncontrolled hypertension and high blood glucose levels,
6. Severe obstructive nasal disease,
7. History of previous oropharyngeal surgery
8. Having a body mass index of 40 kg/m2 or more,
9. Using drugs, alcohol, sedative and hypnotic drugs,
10. Having a cognitive problem