cyrilzakka/clinical-trials huggingface dataset:
Prediction of Long-term Outcome in Aortic Stenosis After Valve Intervention

Patients with severe aortic stenosis accepted for transcatheter intervention or open surgery are included before the intervention, and then followed up with clinical visits during the first year after intervention. Imaging with echocardiography and computed tomography (CT) are performed together with additional imaging with magnetic resonance imaging (MRI) and Positron emissions tomography (PET)-CT in a subgroup of the study population. Blood samples, physical performance and questionnaires with focus on frailty and heart failure are also collected at each visit. A follow up with information of the outcomes after 2-5 years will be performed through national registries.


Eligibility Criteria:
Inclusion Criteria:

* Accepted for aortic valve intervention

Exclusion Criteria:

* No able to follow the study protocol
The Diagnostic Efficacy of Glutamine Synthetaseand BCLAF1in Early Diagosis of Hepatocellular Carcinoma in Cirrhotic Patients

Hepatocellular carcinoma (HCC) is the most prominent kind of liver cancer, accounting for 85% of primary liver malignancies. It is a very aggressive tumor, having a terrible prognosis and poor survival rate HCC is ranked as the sixth most common type of cancer and the third leading cause of cancer-related mortalities world wide.

HCC incidences arise in complications associated with chronic liver disease like cirrhosis, endemic hepatitis B virus (HBV)/hepatitis C virus (HCV) infections, non alcoholic fatty liver disease (NAFLD), and alcohol-related liver disease (Torre, 2015).


Eligibility Criteria:
Inclusion Criteria:

* A total 90 adult patients with liver cirrhosis attending the outpatient clinic or in patient section of the department of tropical medicine and gastroenterology at Sohag University Hospital will be included in the study. Patients will be divided into two groups:

Group I:

The study group will include 45 patients diagnosed with liver cirrhosis with absence of hepatic focal lesion as control group. Cirrhosis will be determined according to clinical , sereological ,radiological findings.

Group II:

The study group will include 45 patient with HCC on top of liver cirrhosis .All causes of liver cirrhosis will be accepted .HCC will be assessed by triphasic CT or MRI or histological validation .In these group we will take patients with liver cirrhosis with early hepatocellular carcinoma that defined as tumors smaller than 3cm and three or fewer in number at stage A according to BCLC staging also sometimes it includes solitary tumors up to 5 cm in size as defined in the Milan criteria. Both very early and early stage tumors are relatively small but both are hyper vascular in arterial phase.

Exclusion Criteria:

1. Non cirrhotic patients.
2. Patients with distant metastasis.
3. Patients aged below18 years.
4. Patients with other malignancy rather than HCC.
5. Patients with late stage of HCC.
A Comparison Between the Repeatability of Probing Pocket Depths Achieved With Manual and Automated Periodontal Probes

The aim of the study is to determine the best method for measuring the extent and severity of the gum disease by comparing the repeatability of probing depths achieved by a manual probe when compared to an automated probe.

Hypothesis

The null hypothesis to be tested includes

* The automated probe does not improve the reproducibility of periodontal probing when compared to manual probing recordings
* The automated probe shows no advantage when comparing the reproducibility of

  * Moderate sites
  * Deep sites
  * Single vs. multirooted teeth
  * Different sextants
  * Different surfaces of teeth Buccal vs. palatal/lingual Mesial vs. mid vs. distal

Measuring the clinical attachment loss using a periodontal probe is the benchmark by which attachment loss is diagnosed in periodontal disease. The accuracy and reproducibility of the probing measurements is an essential part of diagnosis, treatment planning and assessment of the treatment outcome. There are inherent errors associated with probing that have been identified in the literature. These relate to the operator technique, the probe used and the state of inflammation of the periodontal pocket/crevice.

The aim of this study is to compare the reproducibility of probing measurements using a probe tip with millimeter markings up to 15mm in the Florida probe ® handpiece. This tip will be used to allow conventional clinical measurements to be recorded at the same time as the electronic recordings on the Florida probe ®. The examiner would take the manual probe measurement and be blind to the electronic reading taken. The sites under question will have a second measurement recorded to allow assessment of the repeatability of the recordings. Therefore, from 2 probing passes 4 measurements would be obtained 2 manual and 2 electronic readings.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and over
* Diagnosis of periodontitis (any form) but must have at least 2 sites in at least 1 sextant with a BPE code 4( pockets ≥ 5.5mm) at the time of screening
* Patient consent gained and has agreed to be a part of the study

Exclusion Criteria:

* Any medical condition that would exclude them from having the measurements taken
* Any medical problem that would make participation difficult
* If they do not have sufficient sites where probing depths are required.
EGFR CART Cells for Patients With Metastatic Colorectal Cancer

This is a clinical study to observe the maximum tolerated dose (MTD) and the safety and feasibility of chimeric antigen receptor EGFR (EGFR CART) cells in metastatic patients with colorectal cancer.

This is a study for the patients with colorectal cancer. Maximum tolerated dose climbing test is expected into the group of 9 cases of patients. And Phase II expected into the group of 11 subjects, selected the above safe dose, carrying out a research into the clinical effectiveness. Subjects will be collected their T cells and modify them, the modification is a genetic change, that EGFR:4-1BB:CD28:CD3 modified T cells, in order to tells the T cells to recognize their target tumor cells and potentially kill them, but not other normal cells in the subject's body. The CART cells will then be expanded in vitro and then administered to subjects. The purpose of this study is observe the MTD and to assess the safety and feasibility of CART cells in the patients with metastatic colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients must be 18 years to 70 years;
* 2. Clinical diagnosis of EGFR positive for patients with metastatic colorectal cancer;
* 3. Patients must have a KPS of \>80, expected survival \> 3 months;
* 4. Patients must have at least one measurable lesions;
* 5. Recently did not use glucocorticoid;
* 6. Patients must have evidence of adequate hepatic and renal function as evidenced by the following laboratory parameters: WBC ≥ 4.0×109/L, Hb ≥90 g/L, PLT ≥100×109/L）; AST ≤2.5ULN，ALT ≤ 2.5ULN; Cr≤ 3ULN; TBIL≤ 3ULN，
* 7. Patients must have a good heart function (LVEF\>50%) ;
* 8. Patients must be willing to practice birth control during and for three months following treatment.NOTE:female participants of reproductive potential must have a negative serum pregnancy test, and willing to practice birth control during and for three months following treatment；
* 9. Patients must be willing to sign an informed consent.

Exclusion Criteria:

* 1. Patients with other cancer history;
* 2. Patients allergic to cetuximab;
* 3. Patients with severe bronchitis, bronchial asthma, or severs pneumonia;
* 4. Patients with uncontrolled active infections (bacteria, viruses or fungi infection) ;
* 5. Patients with acute and chronic GVHD (graft versus host disease)
* 6. Patients with severe autoimmune diseases;
* 7. Previously treatment with T cell inhibitors (cyclophosphamide, FK506);
* 8. Patients with active hepatitis B or hepatitis C infection, HIV infection, syphilis serology reaction positive;
* 9. Patients who are participating or participated any other clinical research in the past 1 months;
* 10. Pregnant and/or lactating women will be excluded;
Clinical Outcome in View of Surgical Site Infection (SSI) With Antibacterial Skin Sutures

Background: Poor wound healing and the development of surgical site infection (SSI) continue to occur and remain a significant cause of disability among operated patients. In spite of the substantial advances in our understanding of the epidemiology, pathogenesis and prevention it remains one of the most common complications in conventional abdominal surgery with an incidence in the literature between 4% and 17%. As it is known that surgical sutures potentiate the development of wound infection the search for an ideal suture material, suitable for all purposes has been pursued by surgeons for decades.

Hypothesis: In line with in-vitro results the investigators hypothesize that the use of antibacterial skin sutures with triclosan poliglecaprone 25 reduces the rate of SSI after open abdominal surgery Methods: To prevent microbial colonization of suture material in operative wounds and therefore to prevent SSI, triclosan-coated poliglecaprone 25 suture materials with antibacterial activity will be tested against un-coated suture material for skin closure after open abdominal surgery of 200 patients. The study is planed as a single center, randomized controlled trial. After ethical approval the patients will be consecutively enrolled from 2011 to 2012 in the Department of Visceral Surgery, University Hospital Basel, Switzerland. The patients will be followed for 30 days (day 3,7 and 30) to detect and document wound complications. Wound complications will be classified according to Center for Disease Control and Prevention Standard guidelines. Data will be collected and the rate of SSI will be analysed in both groups.

Expected value of the proposed project: If the investigators can confirm the proposed hypothesis in our study this could be a promising and feasible approach to lower SSI after open abdominal surgery and might be also used in other surgical fields. By lowering the rate of SSI the investigators might offer a new and cost saving procedure to the surgical community.


Eligibility Criteria:
Inclusion Criteria:

* All patients from the Visceral Department of Basel University Hospital requiring open abdominal surgery. Open abdominal surgery is defined as: opened peritoneal cavity

Exclusion Criteria:

* factors limiting the ability to co-operate in the study;
* absence of signed informed consent before entering the study;
* people with mental disorders;
* pregnant women;
* participants under 18 years
Clinical Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®)

This clinical study compares the efficacy, safety, and tolerability of therapy with ponesimod vs placebo in subjects with active RMS who are treated with DMF (Tecfidera®).

The study will assess the efficacy, safety, and tolerability of add-on therapy with ponesimod 20 mg vs placebo in adult participants with active relapsing multiple sclerosis (RMS) who are treated with dimethyl fumarate (DMF). Approximately 600 participants who have been receiving DMF for at least 6 months will be randomized in a 1:1 ratio to ponesimod 20 mg or placebo. The study consists of the following study periods: Pre-randomization period; Treatment period; Post-treatment observation period. The study includes one ponesimod treatment arm at the maintenance dose of 20 mg o.d. corresponding to the optimal dose when used as monotherapy based on the Phase 2 dose-finding trial and its ongoing extension. The study includes a placebo comparator arm, but all patients will remain on DMF background therapy throughout the study. Moreover, participants who experience a confirmed relapse or an event of 24-week confirmed disability accumulation (DMF) while on study drug will have the option to switch to an alternative treatment. The treatment period has a variable duration from a minimum of 60 weeks (for the last subject randomized) to a maximum of 156 weeks for the first subjects randomized in the trial and includes a gradual up-titration of ponesimod from a 2 mg starting dose to a 20 mg maintenance dose over a period of 14 days. The total duration of the study will be approximately up to 167 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to initiation of any study-mandated procedure.
* Women of childbearing potential must have a negative pregnancy test and use reliable methods of contraception
* Presenting with a diagnosis of MS as defined by the revised (2010) McDonald Diagnostic Criteria for MS with relapsing course from onset (i.e., relapsing-remitting multiple sclerosis (RRMS), or secondary progressive multiple sclerosis (SPMS) with superimposed relapses).
* Ongoing treatment with DMF for at least 6 months prior to screening
* Active disease after at least 3 months of DMF treatment
* Ambulatory and with an EDSS score between 0 and 6.0 (inclusive).

Exclusion Criteria:

* Lactating or pregnant women and women intending to become pregnant during the study.
* Presenting with a diagnosis of MS with progressive course from onset (i.e., primary progressive MS or progressive relapsing MS).
* Evidence of a relapse of MS with onset within 30 days prior to baseline EDSS assessment.
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Chemotherapy of Elderly Patients With Non-Small-Cell Lung Cancer (NSCLC)

The last ASCO recommendations in 2003 for the treatment of a CBNPC of stage IIIB/IV of elderly people, are to manage a monochemotherapy. Paclitaxel in association with carboplatin is feasible in elderly patients and the retrospective analysis of two studies of the comparing SWOG, one this association with that of cisplatine and vinorelbine and the other cisplatine only with cisplatine and vinorelbine, showed among 117 the 70 years old patients and more, the absence of significant difference of survival and toxicity compared to the younger patients. The study recently published of Lilenbaum and Al shows that among patients with bad PS, association carboplatine and paclitaxel do better than the paclitaxel only. The paclitaxel managed in weekly form is likely of a better activity by exposing the cancerous cells in a repeated way with shorter intervals without allowing the emergence of resistant clones and by allowing an increase in the intensity of amount. This mode of administration appeared at the same time effective and tolerated very well among patients of more than 70 years. The weekly association of carboplatin and paclitaxel was tested in phase II and showed a rate of response of 14% and one survival 1 year from 31% a randomized test (not dedicated to the old person) of phase II to 3 arms was led by Belani et al.. The best combination of carboplatine + paclitaxel weekly proved to be that associating paclitaxel 100mg/m² 3 weeks out of 4 and carboplatine AUC 6 in J1 with J1 = J29. A test of phase II dedicated the 70 years old to patients and more was carried out in France taking again this association carboplatine (AUC 6) every 4 weeks and paclitaxel weekly (90 mg/m² J1, J8 and J15). This test having included 51 patients highlighted a median of 10,42 months survival (IC 95%: 7,29-17,05)

It thus seemed to us justified to compare a standard arm, the vinorelbine or the gemcitabine (with the choice of the center) in monotherapy with an experimental arm, association carboplatine + paclitaxel. To avoid skewing the results by the introduction of a second line to the choice of the investigator, we chose to force it. It is thus the erlotinib which in a recent test presented by the NCIC at the ASCO 2004 proved its effectiveness in second or third line at the same time in term of response but more especially survival compared to the purely palliative care.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically / cytologically proven NSCLC stage IIIB or IV
* age \>= 70 years old and \< 90 years old
Study of Thoracic Ultrasound As a Response to the Closure of Hemodynamically Significant Patent Ductus Arteriosus in Premature Infants

The diagnostic hypothesis is based on the evidence that, while the functional closure of the PDA (Patent Ductus Arteriosus) occurs within a few hours after birth, anatomical closure may take several weeks. The functional closure of the PDA can be extremely sensitive to variations in blood oxygen tension and the hemodynamic instability of preterm infants. Therefore, echocardiographic evaluation and ductal diameter at a single point in time (such as during PDA echocardiography) may not correlate with transductal blood flow. Assessing the variation in the amount of pulmonary interstitial fluid using LUS (lung ultrasound score) could be an early predictive parameter for the closure or non-closure of hsPDA (hemodynamically significant PDA).


Eligibility Criteria:
Inclusion Criteria:

* Neonates under 28 days of life
* Patients eligible for hsPDA closure treatment according to standard clinical practice

Exclusion Criteria:

* Neonates with congenital heart diseases (except for PDA and patent foramen ovale)
* Neonates with pneumothorax
* Neonates with pulmonary hemorrhage
Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot be Removed by Surgery

This clinical trial studies radiolabeled glass beads (yttrium Y 90 glass microspheres) in treating patients with unresectable hepatocellular carcinoma. Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be an effective treatment for liver cancer.

PRIMARY OBJECTIVES:

I. Provide oversight to treatment with TheraSphere to eligible patients with hepatocellular carcinoma (HCC) of the liver who are not surgical resection candidates.

II. Evaluate patient experience, toxicities and overall survival associated with TheraSphere treatment.

OUTLINE:

Patients receive yttrium Y 90 glass microspheres intra-arterially (IA) on day 0, and may receive a second dose within 30-90 days of initial treatment. Patients may receive additional treatment 4-12 weeks after initial treatment at the discretion of the study physician.

After completion of study treatment, patients are followed up at 3-6 weeks and annually for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of intrahepatic malignancy including but not limited to HCC; the histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as alpha-fetoprotein (AFP) and clinical findings
* Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2
* Life expectancy \>= 3 months
* \> 4 weeks since prior radiation, surgery or chemotherapy
* Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines
* Ineligible for surgical resection

Exclusion Criteria:

* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 5 times upper limit of normal (UNL)
* Serum bilirubin \> 2.0 mg/dl (unless segmental infusion is planned)
* Any contraindications to angiography and hepatic artery catheterization such as:

  * History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine that cannot be corrected or premedicated
  * Bleeding diathesis, not correctable by usual forms of therapy
  * Severe peripheral vascular disease that would preclude catheterization
* Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs in a single treatment
* Evidence of pulmonary insufficiency
* Evidence of any detectable technetium-99m macroaggregated serum albumin (Tc-99m MAA) flow to the stomach or duodenum, not correctable by using established angiographic techniques to stop or mitigate such flow
* Significant extrahepatic disease representing an imminent life-threatening outcome
* Active uncontrolled infection
* Significant underlying medical or psychiatric illness
* Co-morbid disease of condition that would preclude safe delivery of TheraSphere treatment or, in the judgment of the physician, place the patient at undue risk
* Pregnancy
Ultrasonographic Insulin Versus Dexamethasone Injection With Local Anestheticss in Diabetic Patients With Mild to Moderate Median Nerve Entrapement Neuropathy .

Insulin injection in carpal tunnel compared with dexamethsone in diabetic patients

Trial to decrease median nerve entrapement neuropathy recurrence using insulin co-injection

Eligibility Criteria:
Inclusion Criteria:

* All diabetic patients with carpal tunnel syndrome

Exclusion Criteria:

* Refusal to participate
The Effect of Motivational Interviewing Technique on Smoking Urge and Smoking Cessation Success in Teachers

Background: Smoking, which remains one of the biggest public health threats that the world faces and has reached epidemic proportions, continues to cause more than eight million deaths on average per year worldwide. The aim of the study was to evaluate the effect of motivational interviewing technique on the smoking urge and the success of smoking cessation in teachers.

Methods: This was an experimental (randomized controlled) study where motivational interviews were conducted with the individuals in the experimental group. The sample of the study was chosen from the teachers, who met the inclusion criteria, in the secondary schools in the central districts of Manisa. The study was completed with 30 smokers in the experimental group and 31 smokers in the control group. Questionnaire on Smoking Urges, Smoking Cessation Success Prediction Scale and Sociodemographic Data Form were used as data collecting tools. Chi-square test, Mann-Whitney U test, Wilcoxon test, t-test and regression analysis were used to analyse the data.


Eligibility Criteria:
Criteria for inclusion

* Individuals who volunteered to participate in the study,
* Did not have a malignant disease or a psychiatric problem,
* Were smokers,
* Taught at schools included in the study were enrolled.

Exclusion criteria

* Those who did not volunteer to participate in the study
* Non-smokers
Is the IVF Outcome Dependent on the Time Interval Between hCG Administration and Oocyte Retrieval?

During controlled ovarian hyperstimulation (COH), human chorionic gonadotrophin (hCG) is administered to trigger the final follicular maturation before oocyte retrieval, in an attempt to mimic the physiologic effects of LH. The hCG is administered when more than three follicles ≥17mm in mean diameter have developed.

The time interval between hCG administration and oocyte retrieval is of critical importance since the time after luteinizing stimulus is a period of intense processes including the start of luteinization, expansion of cumulus cells and oocyte meiotic maturation.

The commonly practiced hCG administration time of 33 to 36 h in most IVF cycles aims to avoiding spontaneous ovulation before oocyte retrieval. However, several studies have shown that significantly more high quality embryos have been obtained with a prolonged hCG-to-oocyte interval of 38 h. It has been hypothesized that longer interval would be beneficial in improving oocyte quality and achieving optimal maturation.

Currently there are no data on the effect of the time interval between hCG administration and oocyte retrieval on IVF outcome in GnRH antagonist cycles. The aim of this study is to determine whether there is any difference in in vitro fertilization outcome when oocyte retrieval takes place at 36 h or 38 h following hCG administration


Eligibility Criteria:
Inclusion Criteria:

* women undergoing fresh IVF cycle with recombinant FSH and GnRH antagonists
* regular spontaneous menstrual cycle (24-35 days)
* age ≤ 43 years
* FSH ≤ 20 IU/L

Exclusion Criteria:

* History of previous ovarian surgery
* Women with Stage III-IV Endometriosis
* Women undergoing natural cycle IVF