cyrilzakka/clinical-trials huggingface dataset:
The Preoperative Predictors of Optimal Cytoreductive Surgery in Women With Advanced Ovarian Cancer

44 patients were enrolled in this study as they had malignant epithelial ovarian tumor.Pre-operative staging was assessed by CT scan based on FIGO classification and compared to the standard laparotomy surgical staging. Maximal surgical effort for Optimum cytoreduction was achieved and the risk factors for sub-optimal cytoreduction were studied

Each patient was subjected to comprehensive medical history taking and careful clinical examination, laboratory investigations (CA-125) and imaging (abdomino-pelvic CT scan). Patients with suspected bowel involvement were subjected for colonoscopy.

Pre-operative Abdomino-pelvic CT scans:

Preoperative CT scans were performed with a high-speed scanner after the oral and intravenous administration of contrast medium. The hard copy images were reviewed by consultant radiologists for assessment of the findings suggestive of malignant adnexal mass which are bilateral lesions, thick septa, enhancing solid components, ascites, and peritoneal deposits .

Pre-operative staging of cancer ovary was assessed by CT scan based on FIGO classification:

1. Stage II: tumor involving ovaries with pelvic extension +/- ascites.
2. Stage III: tumor involving ovaries with peritoneal implant outside pelvis +/- ascites.
3. Stage IV: tumor involving ovaries with parenchymal liver metastasis and/or pleural effusion.

Surgical treatment:

All patients underwent standard longitudinal laparotomy, intensive surgical staging and maximal surgical effort for Optimum cytoreduction which was included all of the following (total abdominal hysterectomy, bilateral salpingo-oophorectomy, infracolic-omentectomy, appendectomy, surgical removal of all tumor masses, intestinal resections if required).Achievement of no gross residual disease has been attempted in all cases. Finally, patients were divided into two groups:

* Suboptimal cytoreduction group with any gross tumor residue.
* Optimal cytoreduction group without any gross tumor residue.

Surgical risk factors for optimum cytoreduction:

* Parenchymal liver involvement.
* Omental involvement.
* Bowel involvement.
* Para aortic lymph node involvement.
* Peritoneal carcinomatosis: it is defined as disease \> 4 mm involving 2 or more of the following areas; lateral colic gutters, anterior abdominal wall, diaphragm, and pelvic peritoneal reflections.
* Pelvic sidewall invasion: it is defined as presence of one or more of the following; tumor fixed to the pelvic bony wall, encasement of iliac vessels, and hydroureter.

Eligibility Criteria:
Inclusion Criteria:

* malignant epithelial ovarian tumor (EOC)

FIGO stage II, III, and IV.

Exclusion Criteria:

* Patients with previous abdominal or pelvic major surgery, synchronous abdominal or pelvic pathology or medically unfit for surgery
Evaluation of the Public Health Interest of Kaletra: Impact on Resistance to Antiretrovirals (ARVs)

The purpose of this study is to evaluate, in patients in at least the second protease inhibitor (PI) line, the virological failures under Kaletra® and their consequences on protease and reverse transcriptase genotypes

The purpose of this study is to evaluate, in patients in at least the second PI line, the virological failures under Kaletra® and their consequences on protease and reverse transcriptase genotypes:

* Characterisation of the changes in the resistance genotype in protease and reverse transcriptase,
* Description of the nature and frequency of selected mutations under Kaletra®,
* Description of the predictive factors for mutations and of the impact they could have on other PIs used as maintenance treatment (analysis based on available algorithms).

EOLE is a prospective, multicentre observation study offered to French virology laboratories and involving clinical teams .

It is a transversal study with retrospective data collection for patients meeting the study criteria (virological failure under Kaletra® after at least first line PI treatment).

The study comprises two enrolment periods, separated by an interval of one year, over a period ranging from 2007 to 2011. During this period, virological failures under Kaletra® are identified. For each period, the virologists collect data only from the moment when virological failure under Kaletra® is identified.

The first wave of data collection is now completed and occurred from December 5, 2007 to July 03, 2009.

It is not planned to collect follow-up data in connection with alternative treatment with other antiretrovirals after failure under Kaletra®.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged under 18 years,
* Pre-treated by at least one protease inhibitor (PI) line,
* In therapeutic failure of the antiretroviral (ARV) maintenance treatment containing Kaletra®.

Therapeutic failure is defined by a viral load\> 50 copies/ml after at least three months' treatment with an ARV combination containing Kaletra®, always provided that genotyping is possible .

Exclusion Criteria:

* Patients having received less than three months of Kaletra®,
* Patients for whom the genotype information before starting Kaletra® and at the time of the failure of Kaletra® was not available,
* Patients receiving another protease inhibitor (PI) concomitantly with Kaletra®.
Influenza and Text Messaging in Pregnancy

A randomized, controlled clinical trial to assess whether text messaging to an outpatient obstetric population can improve maternal influenza vaccine uptake.

History and the 2009 H1N1 influenza pandemic suggest that both seasonal and pandemic influenza infections impart disproportionate morbidity and mortality among gravidas. The influenza vaccine represents a viable, preventive health intervention to mitigate disease burden for gravidas and their neonates. Despite the safety and efficacy of influenza vaccines, suboptimal maternal vaccination rates (13-24%) persist nationwide. Barriers to influenza vaccination during pregnancy include patient concerns about vaccine safety and unappreciated risk of influenza infection. Cellular phone text messaging has emerged as an innovative technology with advantages of ubiquity, rapid, confidential information transmission, and low cost. Text messaging may represent an effective way to educate pregnant women about their particular vulnerability to influenza infection and enhance influenza vaccine uptake. We propose a randomized, controlled clinical trial to assess whether text messaging to an outpatient obstetric population can improve maternal influenza vaccine uptake.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women less than 28 weeks estimated gestation age
2. Between 14-50 years of age
3. Willing to provide informed consent and undergo necessary study procedures

Exclusion Criteria:

1. Unwillingness or inability to receive text messages
2. Receipt of the current season's influenza vaccine or plan to receive the influenza vaccine on the day of the enrollment visit
3. Reported history of adverse reaction precluding receipt of the vaccine
4. Unwillingness or inability to provide informed consent and comply with study criteria.
Treatment of Patients Suffering From a Progressive Pancreas Carcinoma With Everolimus (RAD001) and Gemcitabine

A dose finding study in locally advanced and/or metastatic pancreatic cancer patients


Eligibility Criteria:
Inclusion criteria:

1. Histologically confirmed locally advanced, irresectable pancreatic adenocarcinoma (head, corpus, tail) with or without distant metastases
2. Adequate bone marrow, liver and renal function on everolimus treatment
3. At least one measurable lesion according to RECIST criteria that has not been previously irradiated.
4. Patients must be at least 4 weeks since prior major surgery and recovered, at least 2 weeks and recovered since prior minor surgery, completion of radiation, or completion of all prior systemic anticancer.
5. Age \>18 years

Exclusion criteria:

1. Women who are pregnant or breast feeding.
2. Documented intolerance or history of allergy to everolimus or Gemcitabine.
3. History of another malignancy within 5 years prior to study entry, except curatively treated non-melanotic skin cancer or in-situ cervical cancer
4. Known or symptomatic central nervous system (CNS) metastases or leptomeningeal involvement
5. Chronic treatment with systemic steroids or another immunosuppressive agent
6. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus
7. Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumarin). Quick-value \< 50 % or prothrombine time more than 1,5 fold higher

Other protocol defined inclusion/exclusion criteria may apply
Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes (DURATION-4)

This study will compare the effects of 2.0 mg exenatide once weekly injection as monotherapy to 3 active comparators(metformin, dipeptidyl peptidase-4 inhibitor, and thiazolidinedione) in drug naive patients with type 2 diabetes treated with diet and exercise.


Eligibility Criteria:
Inclusion Criteria:

* have type 2 diabetes and are treated with diet and exercise alone.
* at least 18 years of age.
* HbA1c between 7.1% and 11.0%, inclusive.
* Body mass index (BMI) of 23 kg/m2 to 45 kg/m2, inclusive.
* Have a history of stable body weight (not varying by \>5% for at least 3 months prior to screening).

Exclusion Criteria:

* Have history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty
* Have a history of renal transplantation or are currently receiving renal dialysis
* Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
* Have history of severe GI disorder (e.g., gastroparesis)
* Have a history of acute or chronic pancreatitis.
* Have active proliferative retinopathy.
* Have been treated with drugs that promote weight loss (e.g., Xenical®\[orlistat\], Meridia® \[sibutramine\], Acomplia® \[rimonabant\], Acutrim® \[phenylpropanolamine\], or similar over-the-counter medications) within 3 months of screening.
* Have been treated with any antidiabetic agent for more than 7 days within 3 months prior to screening.
* Have had an organ transplant.
* Have previously completed or discontinued study drug in this study, withdrawn from this study or any other study investigating exenatide once weekly.
* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
* Are currently enrolled in any other clinical study.
Monitoring of Hydration Status in Chronic Hemodialysis Patients

Background Maintaining fluid balance is one of major challenges of the dialysis therapy. It includes, in particular, the management of "dry body mass". We postulated that simple measurement of subscapular skinfold thickness before and after hemodialysis could help monitor hydration status in chronic dialysis patients.

Aim of the study The aim of the study was to compare the conventional methods of monitoring hydration status during hemodialysis with an assessment of skin fold thickness.

Materials and Methods 50 participants (21 F, 29 M; age 60 ±15 years) were enrolled. Directly before the hemodialysis session the following parameters were measured: body composition with bioimpedance spectroscopy, skinfold thickness in subscapular area with standardized caliper and blood tests: blood count, urea, n-terminal pro B-type natriuretic peptide (nt-proBNP) and pro-adrenomedullin (pro-ADM). The procedures were repeated at the end of three consecutive hemodialysis sessions.


Eligibility Criteria:
Inclusion Criteria:

* chronic hemodialysis for at least 3 months

Exclusion Criteria:

* severe mental disabilities, poor compliance, any acute infection, instability of the cardiovascular hemodynamic condition
Effect of Poly Amido Amine Dendrimer, Nano-hydroxyapatite

Dental caries is a common oral disease. The process of caries formation is a cycle of remineralization and demineralization with various stages being either reversible or irreversible.

White spot lesions (WSLs) are defined as enamel surface and subsurface demineralization, without cavitation. These manifestations represent the first clinical observation of the progression of dental caries, with the possibility of being reversed.

WSLs are characterized by a white, chalky, opaque appearance and are commonly located in pits, fissures, and smooth surfaces of teeth. However, after the placement of fixed orthodontic appliances, there are an increasing number of plaque retention sites due to the presence of brackets, bands, wires and other applications, which make oral hygiene more difficult, and limit naturally occurring self-cleansing mechanisms. As a consequence, there is an increased risk of demineralization and, conclusively, of WSLs forming on smooth surfaces, if there is no effective plaque removal

The clinical characteristics of these lesions include loss of normal translucency of the enamel because of altered light properties with a chalky white appearance, particularly when dehydrated; a fragile surface layer susceptible to damage from probing, particularly in pits and fissures; increased porosity, particularly of the subsurface, with increased potential for uptake of stains; reduced density of the subsurface, which may be detectable radiographically, with transillumination or with modern laser detecting devices; and potential for remineralization, with an increased resistance to further acid challenge particularly with the use of enhanced remineralization treatments.

It is possible to find numerous therapies for WSLs, for instance, hygiene education, fluorides, phosphopeptide compounds, xylitol and infiltrative resins, microabrasion and/or bleaching, and preparation and restoration. The professional application or prescription of fluorides for home use includes: gels, toothpastes, mouthwashes and varnishes. The fluoride ions are revealed in three ways: sodium monofluorophosphate, sodium fluoride and amine fluoride. It has been found that high fluoride concentrations promote WSL remineralization However; it occurs in the enamel surface and inhibits the ions' movement through the subsurface, affecting the subsurface remineralization and therefore, the light reflection

Eligibility Criteria:
Inclusion Criteria:

* The patients have at least 3 WSLS.
* The patients aged between 16 and 25 years old
* The patients with good general health and no systemic disease.

Exclusion Criteria:

* Presence of enamel hypoplasia or dental fluorosis.
* Presence of carious cavity.
* Allergy to fluoride gel being used in this stufy
* Patients who have a significant medical history, including pregnancy and breast feeding and smokers.
* Patients who have evidence of reduced salivary flow or significant tooth wear.
* Patients who had participating in concurrent clinical trials or who had recently participated in other clinical trials of an investigational drug or device.
Evaluation of Education for Gestational Diabetes

Prospective observational cohort study of women with gestational diabetes (GDM) based on the 'International Association of Pregnancy Study Groups' (IADPSG) criteria. The overall aim is to evaluate the knowledge regarding GDM of women with GDM and to evaluate the satisfaction of women with GDM about the education they receive (given in group or individually). Normal routine care is followed and evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Women ≥ 18 years diagnosed with GDM in the university hospital Leuven.

Exclusion Criteria:

* Women who received bariatric surgery.
* Women with pregestational diabetes or diagnosed with diabetes during early pregnancy.
Optimized Diagnostics for Improved Therapy Stratification in Invasive Fungal Infections

Invasive fungal infections (IFI) in immunocompromised patients pose a major challenge for diagnostics designed to permit timely onset of appropriate treatment. The aim of the current clinical-diagnostic studies, one in in pediatric and one in adult patients at high risk of IFI, is to test newly developed diagnostic approaches to invasive fungal infections in relation to established procedures. The studies will be performed in a prospective, blinded fashion, and represent a work package within the FUNGITECT grant supported by the European Commission. The studies will focus on analyses of blood-samples from patients with febrile neutropenia during treatment of acute leukaemia and other tumour entities, and patients undergoing allogeneic stem cell transplantation treated with intensive chemotherapy.

Samples from immunosuppressed patients with febrile neutropenia (NP - defined as fever ≥ 38.5ºC and \<500 ANC) will be taken:

* at the start of neutropenic fever
* after 24 hours
* after 48 hours
* before the start of antimycotic therapy, if pertinent
* at the end of antimycotic therapy, if pertinent

The results ot analyses by a panfungal PCR screening assay developed at our institution (European patent No 1960536) and methods newly developed during the FUNGITECT project will be compared with conventional methods for fungal diagnostics such as HR (High Resolution)-CT, serological testing, histology and fungal culture. Additionally, genomic approaches will be employed to investigate host- and pathogen-related factors of susceptibility, pathogenicity and antimycotic resistance.

Eligibility Criteria:
INCLUSION CRITERIA

Adult study:

* Patients between 18-90 years of age with high risk of invasive fungal infections
* signed informed consent

Pediatric study:

* patients between 0-18 years of age with high risk of invasive fungal infections
* signed informed consent

EXCLUSION CRITERIA

Adult study:

* pregnancy
* no consent

Pediatric study:

- no consent
Chinese PD-LRRK2 Registry

The purpose of the Chinese PD-LRRK2 Registry(CPD-LRRK2R) is to develop a database of patients of Parkinson's disease with leucine-rich repeat kinase 2 (LRRK2) gene variants in mainland China.

Parkinson's disease (PD) is the second most common disorder among neurodegenerative diseases. LRRK2 missense mutations are the most common known genetic cause of PD. However, some polymorphisms of LRRK2 such as G2385R and R1628P can also affect the risk of developing PD. The investigators aim to establish a database of PD with LRRK2 variants and characterize the clinical manifestation of these patients in mainland China.

Method:

1. Peripheral blood from patients has been tested to have LRRK2 gene variants.
2. Clinical manifestation will be measured by scales and neurological tests. Standard scales include: Unified Parkinson's Disease Rating Scale(UPDRS), Hoehn-Yahr stages, Non-Motor Symptoms Scale (NMSS), mini-mental state examination (MMSE), Parkinson disease sleep scales (PDSS), Rapid Eye Movement Sleep Behaviour Disorder Questionnaire(RBDQ-HK), Epworth Sleepiness Scale (ESS), Rome III functional constipation scale, the Scale for Outcomes in PD for Autonomic Symptoms (SCOPA-AUT), Parkinson Fatigue Scale (PFS), Cambridge-Hopkins Restless Legs Syndrome questionnaire (CHRLSq), Hyposmia rating scale(HRS), Hamilton depression scale, the 39-item Parkinson's Disease Questionnaire(PDQ-39), Freezing of gait scale(FOG), dyskinesia related scales, Wearing-off scale(WO).
3. The investigators will also exam the blood biomarkers of PD such as uric acid and peripheral inflammatory markers.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with PD by the United Kingdom Parkinson's Disease Society Brain Bank clinical diagnostic criteria or other standard criteria; PD patients detected with positive LRRK2 variants

Exclusion Criteria:

-
Investigating the Efficacy of Combining Virtual Reality-Based Mirror Therapy (VRMT) and Transcranial Direct Current Stimulation (tDCS) to Improve Upper Limb Recovery in Patients with Stroke

This study will investigate whether combining virtual reality-based mirror therapy (VRMT) and transcranial direct current stimulation (tDCS) alongside conventional physical therapy (CPT) will significantly improve hand function for patients with stroke compared to using VRMT or tDCS alone.

More than half of stroke survivors suffer from upper-limb dysfunction that persists years after stroke, negatively impacting patients' independence and, therefore, affecting their quality of life. Motor rehabilitation is required after a stroke to facilitate motor recovery. More importantly, finding new ways to maximize patients' motor recovery is a core goal of stroke rehabilitation. Thus, researchers have explored the potential benefits of using advanced technologies such as virtual reality-based mirror therapy (VRMT) and transcranial direct current stimulation (tDCS) to boost the brain's responses to interventions and maximize the effects of rehabilitation to improve upper-limb recovery post-stroke. However, the potential impact of combining VRMT and tDCS on upper limb functions for patients with stroke has not been explored. Therefore, the goal of this study is to investigate whether combining virtual reality-based mirror therapy (VRMT) with transcranial direct current stimulation (tDCS) alongside conventional physical therapy (CPT) will significantly improve hand function for patients with stroke compared to using VRMT or tDCS alone.

The participants will be randomly assigned into one of the four groups: (1) the anodal tDCS + VRMT group, (2) the anodal tDCS alone group, (3) the VRMT alone with sham tDCS group, and (4) the CPT with sham tDCS group. All groups will receive CPT as part of the treatment. Functional scales will be used before and after the intervention to assess upper motor functions. These measures include the Fugl-Meyer Assessment, Wolf Motor Function Test, Box and Block Test, Nine-Hole Pegboard Test, and Stroke Impact Scale-16 (SIS-16). In addition, physiological measures such as transcranial magnetic stimulation (TMS) and task-based fMRI.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old.
* Stroke patients with unilateral cerebral infarction or hemorrhage, more than three months following the stroke.
* Adequate cognitive ability to follow instructions (The Arabic version of the Mini-Mental State Examination scores \> 24).
* Modified Ashworth scale score \< 3.
* Fugl-Meyer Assessment (FMA) score of 10-58 indicating moderate-to-severe arm impairment.

Exclusion Criteria:

* visual impairment and field defect or hemi-sensory inattention and unilateral neglect.
* Wernicke's aphasia, or global aphasia, leads to difficulty following instructions.
* Any contraindication to NIBS.
* Other neurological conditions or participation in another study.