cyrilzakka/clinical-trials huggingface dataset:
Survival Effect of Hepato-celiac Lymphadenectomy In Primary or Relapsed Ovarian Cancer

The purpose of this study is to evaluate the safety and the effectiveness of hepato-celiac lymphadenectomy in the treatment of primarily diagnosed advanced epithelial ovarian cancer and platinum-sensitive recurrent ovarian cancer.

This single-arm, single-center, phase II trial is to evaluate the safety and effectiveness of hepato-celiac lymphadenectomy in the treatment of ovarian cancer with hepato-celiac lymph nodes metastases, in the circumstance of primarily diagnosed advanced epithelial ovarian cancer (primary debulking surgery or interval debulking surgery) and of platinum-sensitive recurrent ovarian cancer (no more than 4 lines of therapy).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years to ≤ 75 years.
* Pathologic confirmed stage III or IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma (EOC, PPC, FTC) or platinum sensitive, relapsed EOC, PPC or FTC (no more than 4 lines of therapy)
* Assessed by the experienced surgeons, complete resection is feasible according to preoperative evaluation
* 1 to 3 episodes of neoadjuvant chemotherapy is allowed in primary settings
* Platinum sensitive relapse is defined as those with platinum-free interval of 6 months or more.
* ASA score of 1 to 2
* ECOG performance status of 0 to 2
* Adequate bone marrow, liver and renal function to receive chemotherapy and subsequently to undergo surgery:
* White blood cells \>3,000/µL, absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL,
* Serum creatinine \<1.25 x upper normal limit (UNL) or creatinine clearance ≥60 mL/min according to Cockcroft-Gault formula or to local lab measurement
* Serum bilirubin \<1.25 x UNL, AST(SGOT) and ALT(SGPT) \<2.5 x UNL
* Comply with the study protocol and follow-up.
* Written informed consent.

Exclusion Criteria:

* Patients with non-epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma.
* Low-grade carcinoma.
* Mucinous ovarian cancer.
* Infeasible complete resection according to preoperative evaluation
* Unresectable pulmonary and hepatic parenchymal metastases, multiple thoracic lymph nodes metastases, brain or bone metastases according to preoperative evaluation.
* Carcinomatosis on small bowel mesentery or intestinal wall by surgical findings and infeasible optimal surgery by bowel resection or peritonectomy.
* Progression after neoadjuvant chemotherapy in primary settings.
* Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or breast cancer (without any signs of relapse or activity).
* Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol.
* Other conditions, such as religious, psychological and other factors, that could interfere with provision of informed consent, compliance to study procedures, or follow-up.
RChildUV:Study on Non-infectious Chronic Uveitis in Pediatric Age

Uveitis is an inflammatory disease of the uvea, one of the highly vascularized fundamental structures of the eye. It is a rare condition in children, with an incidence in the pediatric population ranging from 2% to 14% of all uveitis cases. The diagnosis and management of patients with uveitis rely on a multidisciplinary approach involving an ophthalmologist, a rheumatologist, and an infectious disease specialist to establish the correct diagnosis and assess the involvement of other organs. In Italy, there is no national or regional registry for non-infectious chronic uveitis as per the Prime Ministerial Decree (DPCM) of March 3, 2017 (Identification of surveillance systems and registries for mortality, tumors, and other diseases). However, many clinical centers adopt data recording systems to evaluate the quality of care and to study diseases and outcomes. The Universitary Hospital Meyer Institute Research Hospital (IRCCS) is a national referral center for managing these pediatric cases of non-infectious chronic uveitis, estimated to constitute 95% of all pediatric uveitis cases


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of non-infectious chronic uveitis before the age of 16;
* signed informed consent form.

Exclusion Criteria:

* Patients with a diagnosis of infectious uveitis
* history of malignant pathology,
* history of demyelinating pathology,
* history of cerebral vasculitis
Personal Patient Profile Prostate (P4) Randomized, Multisite Trial

The purpose of this study is to determine whether or not participation in an experimental program called the "P4 program" is useful to men who are faced with choices about treatment for their early stage prostate cancer. The P4 program consists of a series of questions and information for the participant.

Before seeing the cancer specialist, participants will answer several questionnaires on a computer. This will take about 20-30 minutes. Participants may choose to do this on a computer at home or on a touch-screen computer in the clinic. Half the participants will then be shown several highly rated informational websites about prostate cancer treatments. The other half, based on the individual participant's answers, will receive the P4 program's customized written and on-screen information. Reading the information and watching videos will take about 20 minutes.

About one month later, and again 6 months, participants will complete follow-up questionnaires electronically or by mail. These questionnaires will help us understand how each participant's decision for treatment of their prostate cancer went. Answering these questionnaires should take about 20 minutes each time.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven diagnosis of prostate cancer, stage I or II
* Diagnosis within the past 6 months
* Has appointment with a consulting specialist at one of the clinical trial sites
* Must be able to read and write English or Spanish at a 6th grade level
* Must not have begun any treatment (except watchful waiting)
* Must be able to complete baseline assessment before target clinician visit.

Exclusion Criteria:

* Advanced prostate cancer
* Diagnosed more than 6 months ago
* Cannot read and write English or Spanish at a 6th grade level
* Does not have appointment at one of the clinical trial sites
Prediction of Early Pre-eclampsia From Maternal Factors, Biophysical and Biochemical Markers at First Trimester

The aims of this study are to develop algorithms based on a combination of maternal factors, uterine artery PI, MAP and serum biomarkers to estimate patient-specific risks for early Preeclampsia (PE) and to evaluate the screening performance of such algorithms in twins.

Preeclampsia (PE) is still a leading cause of fetal and maternal morbidity and mortality with an incidence of 3-5% worldwide. Despite intensive research efforts the pathogenesis of the disease is still unknown but it is likely to be multifactorial.Clinical risk factors traditionally have been used to identify women at high risk of developing preeclampsia,and biophysical factors that may help predict hypertensive disorders of pregnancy.In addition,changes in the serum concentrations of angiogenic and antiangiogenic factors are implied in the pathogenesis of PE and have possible relevance in the diagnosis of the disease.

Eligibility Criteria:
Inclusion Criteria:

* twins pregnancies delivering a phenotypically normal stillbirth or live birth at or after 24 weeks of gestation.
* twins pregnancies at at 11-14 weeks of gestation

Exclusion Criteria:

* pregnancies with major fetal abnormalities and those ending in termination, miscarriage or fetal death before 24 weeks
Trial of Yellow 577 nm Laser Versus Green 532 nm Laser for Proliferative Diabetic Retinopathy

The purpose of this study is to measure effectiveness of yellow 577 nm laser compared to conventional green laser 532 nm for diabetic retinopathy in terms of number of treatment sessions required and visual acuity outcome.

The study also compares pain score of patients receiving laser treatment and side effects of laser treatment.

Diabetes mellitus (DM) is a major medical problem throughout the world. The most common and potentially most blinding of these complications is proliferative diabetic retinopathy (PDR).

Panretinal photocoagulation is established as the gold standard of treatment, supported by the data of the Diabetic Retinopathy Study (DRS).This study found that laser treatment reduced the rate of severe visual loss by 50%. Currently the green 532nm laser is the most common wavelength used. However, this conventional green laser has some complications such as pain, vitreous haemorrhage, choroidal effusion and visual field loss.

Due to the complication of conventional lasers, the yellow laser (577 nm)with peak absorption of oxyhemoglobin and good absorption of melanin is postulated to be more effective at producing retinal laser burns with a lower power and less pain compared to the green laser.

Eligibility Criteria:
Inclusion Criteria:

* Patient more than 18 year of age
* Eyes with proliferative diabetic retinopathy requiring laser PRP
* Newly diagnosed patient
* Patients with no other intervention/surgeries done before the study

Exclusion Criteria:

* Eyes with media opacity not allowing adequate laser photocoagulation
* Patients who have had previous laser photocoagulation
* Patients who have had previous vitreoretinal surgery
COVADIS Pilot Trial: COseal in Ventricular Assist DevIceS

The objective of this controlled, non-randomized, single-center pilot study (CoSeal arm prospective)study is to evaluate the efficacy of the synthetic surgical hydrogel CoSeal® in the prevention of cardiac adhesion formation in patients submitted to VAD procedures.

In the past decade the use of ventricular assist devices) (VADs) for bridging to heart transplantation (HTx) or, in some cases, to recovery of the ventricular function has increased and, during the same time, the duration of the implantation period has lengthened dramatically. When removing VADs after a long period, surgeons face severe pericardial adhesions at the mediastinum level and of the surrounding tissue due to the inflammatory response. During resternotomy, dissection of these adhesions increases surgical time and can be a source of lesions on the cardiac or vascular structures and of severe bleeding at the moment of transplantation or when the device is removed.

Many products have been used to prevent or reduce adhesions but an ideal antiadhesive treatment has remained elusive. CoSeal®, a licensed synthetic hydrogel (Baxter, USA) has been shown to reduce pericardial adhesions in a limited series of reoperations.

Eligibility Criteria:
Inclusion criteria (CoSeal group):

1. Written informed consent obtained from the subject prior to participation in the study
2. At least 18 years of age
3. Subjects with indication for LVAD implantation, meeting the requirements for LVAD implantation. Patients for whom the investigator anticipates LVAD removal not earlier than 6 weeks after LVAD implantation.

Inclusion criteria (CoSeal control group):

1. Written informed consent obtained from the subject prior to participation in the study
2. At least 18 years of age
3. Subjects who had a LVAD for more than 6 weeks.

Exclusion criteria (CoSeal group):

1. Concomitant use of any other anti-adhesion product
2. Immune system disorders, immuno-deficiencies or immuno-suppression
3. Known hypersensitivity to components of the study product
4. Patients concurrently participating in another clinical trial for adhesion prevention or sealing evaluation and having received such an investigational drug or device within the previous 30 days
5. Patients who were previously subject to another LVAD implantation/explantation
6. Pregnant or breast-feeding women.

Exclusion criteria (Co Seal control group):

1. Known use of any other anti-adhesion product during VAD implantation
2. Immune system disorders, immuno-deficiencies or immuno-suppression
3. Patients concurrently participating in another clinical trial for adhesion prevention or sealing evaluation and having received such an investigational drug or device within the previous 30 days
4. Patients who were previously subject to another LVAD implantation/explantation
5. Pregnant or breast-feeding women.
Population Pharmacokinetics of Tigecycline in Patients Treated With ECMO

Tigecycline is a commonly used antibiotic in critically ill patients. The pharmacokinetics (PK) of tigecycline in intensive care unit (ICU) patients can be affected by severe pathophysiological changes so that standard dosing might not be adequate. At present, a number of studies have reported that ECMO will affect the PK of anti-infective drugs and lead to treatment failure. The purpose of this study was to describe the population PK of tigecycline in patients treated with ECMO and to evaluate the relationship between individual PK parameters and patient covariates.


Eligibility Criteria:
Inclusion Criteria:

* critically ill hospitalized males or nonpregnant females aged ≥18 years with severe infections which the treating clinician was treating with tigecycline.

Exclusion Criteria:

* People who had taken tigecycline in the past week
* People who were pregnant
* People who had coagulation dysfunction
Longitudinal Study for Relapsing Polychondritis

Relapsing polychondritis (RP) is a rare systemic inflammatory disease characterized by recurrent inflammation of cartilage including ears, nose, tracheobronchial tree, chest wall and joints. Less commonly, it can cause inflammation of eyes, vasculature, nervous system, skin and inner ear. The purpose of this study is to study the pathogenesis of RP.

Relapsing polychondritis (RP) is a rare systemic inflammatory disease characterized by recurrent inflammation of cartilage including ears, nose, tracheobronchial tree, chest wall and joints. Less commonly, it can cause inflammation of eyes, vasculature, nervous system, skin and inner ear. There is variability in organ-system involvement and the disease course is relapsing making the diagnosis challenging. Delay in diagnosis can lead to end-organ damage and significant morbidity and mortality. There are no biomarkers or blood tests that can assist with assignment of a diagnosis.

Development of this longitudinal cohort and multicenter approach offers the potential to generate new insights and generate new questions regarding the immunology of the disease. Attainment of a better understanding of the mechanisms and trajectory of inflammation may yield insights into potential new diagnostic and treatment strategies.

Study visits will occur every 6 months, or annually. Blood and urine collection will occur at every visit. A physical exam and medical and medication history will at every visit; also, participants will be asked to complete several questionnaires to assess disease activity, health status, and tobacco, alcohol, and drug use.

Eligibility Criteria:
Inclusion Criteria:

* 1. Any subject considered to have a diagnosis of relapsing polychondritis according to the investigator.

Exclusion Criteria:

* 1. Inability to provide consent, or in the case of minors, assent.
A Prospective Study of Combination of Peginterferon Alfa-2b (40kD, Y-shape) and GM-CSF in Chronic Hepatitis B

This study is a multi-center, randomized, prospective open-label study to assess the efficacy and safety of combination of peginterferon alfa-2b (40kD, Y-shape) and GM-CSF in interferon-naïve chronic hepatitis B patients with HBeAg positive. Patients were randomized to one of the 2 groups to receive different antiviral treatment.


Eligibility Criteria:
Inclusion Criteria:

* 18yrs≤age≤65yrs.
* 17≤BMI(body mass index)≤28.
* HBsAg positive≥6 months.
* Serum HBV DNA≥20,000IU/ml, HBsAg positive and HBeAg positive at screening.
* 2ULN≤ALT≤10ULN(ULN=upper limit of normal) at screening.
* Pregnancy test must be negative for female patients of childbearing potential. All patients take effective birth control measures during treatment and 6 months after the treatment.
* Agree to participate in the study and sign the informed consent.

Exclusion Criteria:

* Pregnant or lactating females
* Interferon treatment history, or using nucleos(t)ide analogues for chronic hepatitis B treatment within the previous 6 months, or any evidence of nucleosi(t)ide analogues resistance .
* Receiving strong immunomodulatory agents (e.g., steroids, thymosin) for more than two weeks 6 months prior to screening.
* Receiving hepatotoxicity agents (e.g., aczone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than two weeks 6 months prior to screening.
* Co-infected with active hepatitis A, hepatitis C, hepatitis D, and/or human immunodeficiency virus (HIV).
* History or evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g., autoimmune hepatitis, alcoholic liver disease, toxin exposures.
* Suffering from any other acute or chronic infectious disease.
* Mental disorder or physical disability, or family history of neurological and psychiatric disorders.
* Neutrophil count \<1500 cells/mm3, or platelet count \<90000 cells/mm3 at screening.
* Child-Pugh≥B, or other evidence of liver decompensation (e.g. serum albumin\<35g/L , prothrombin time\>3 seconds prolonged, serum bilirubin\>2ULN, prothrombin activity \<60%, history of liver decompensation).
* Serum creatinine level \>ULN in screening period.
* Serum creatine kinase level \>2ULN except for physiological factors (e.g., exercise).
* AFP\>100ng/L. If 50ng/L\<AFP\<100ng/L at screening, retest 2 weeks later, and if AFP \<50ng/L can enrolled, vs, excluded.
* Hepatocarcinoma or suffering from any other malignant tumor.
* Autoimmune disease(e.g., psoriasis, systemic lupus erythematosus).
* Moderate or severe hypertension, or mild hypertension without well controlled.
* With not well- controlled endocrine disease (e.g., thyroid dysfunction, diabetes mellitus).
* Drug abusing, or alcoholism.
* HBeAb positive or HBsAb positive at screening.
* Allergic to interferon, or GM-CSF, or any fragment of the study drug.
* Other conditions which in the opinion of the investigator precluding enrollment into the study(e.g., low compliance).
Effectiveness of Supervised Training Program on Mobility and Balance Confidence in Individual With Lower Limb Amputation

It was quasi experimental study where the researchers assess the effectiveness of supervised training program on mobility and balance confidence in individual with lower limb amputation.


Eligibility Criteria:
Inclusion Criteria:

1. Age range 15-55 years.
2. Both genders: (male and females).
3. Trans-tibial amputation
4. Patients involved in prosthetic rehabilitation (strengthening, balance training, stretching exercises and gait training).

Exclusion Criteria:

1. Patient with cognitive problem.
2. Infection
3. Neuromas
4. Limb swelling
Anabolic Steroids for Nutritional Rehabilitation of Critically Ill Patients

This prospective, double-blinded study will determine the feasibility of determining the efficacy of a weekly intramuscular injection of nandrolone (an anabolic steroid) in malnourished ICU patients.The data from this study will also enable us to prepare a future grant proposal with a calculated sample size necessary to demonstrate an improvement in clinical outcome.

Critically ill patients are particularly prone to excessive catabolism using skeletal muscle as the primary substrate as a result of maladaptation to critical illness. Ultimately, critical illness leads to a significant loss of lean body mass (LBM). For example, a 40% loss of LBM is associated with a 100% mortality. Anabolic steroids have been studied and have been shown to improve nutrition in select malnourished patient groups, however, the majority of these studies were not well designed or consisted of small sample sizes.

Our hypothesis is anabolic steroid administration will result in an augmentation of positive nitrogen balance and LBM. This increase in LBM will result in liberation from mechanical ventilation sooner than the placebo group and will result in discharge from the ICU sooner, and as a result, a reduction in morbidity (nosocomial infections) and possibly mortality.

All moderately to severly malnourished ICU patients who have an anticipated stay in ICU \> 10 days, will be randomized to receive nandrolone (25 mg-females, 50 mg;males) once weekly for six weeks or placebo. All patients will receive a standard enteral nutritional regimen. Patients will be monitored for assessment of nitrogen balance, lean body mass, and length of time spent on ventilator, in ICU and in HOSP, and incidence of infections.Lean body mass will be measured using a bioimpedance analyzer.

Eligibility Criteria:
Inclusion Criteria:

1. anticipated length of stay in ICU \>10 days
2. moderate to severe malnutrition
3. patient tolerating enteral feeds

Exclusion Criteria:

1. age \< 18 yrs
2. known allergy to nandrolone
3. women of child bearing age with positive pregnancy test
4. contraindications to intramuscular injections ie anticoagulation
5. renal failure requiring renal replacement therapy
6. patients with breast or prostate cancer -
Acute Effect of Positive Expiratory Pressure Versus Breath Stacking Technique After Cardiac Surgery

This study evaluates the efficacy and safety of a single session of positive expiratory pressure and of breath stacking technique in patients after cardiac surgery. The same patients will receive the two interventions, with an interval of 24 hours, and the acute effect of each will be verifed.

Physiotherapy uses techniques and equipment that reduce postoperative pulmonary complications. The technique called breath stacking consists of an instrumental feature composed of a unidirectional valve coupled to a face mask to promote the accumulation of successive inspiratory volumes. The technique is used to prevent atelectasis and improve gas exchange. Another therapy is called expiratory positive airway pressure (EPAP) that uses positive end expiratory pressure (PEEP) in spontaneously breathing patients, keeping the airway open during expiration. The EPAP system consists of a face mask, a one-way valve and the expiratory resistor, which is responsible for resistance to expiratory flow, which will determine the level of PEEP.

Eligibility Criteria:
Inclusion Criteria:

Patients with indication for coronary artery bypass grafting and valve replacement, with surgical procedure for median sternotomy.

Exclusion Criteria:

* incapacity to understand the Informed Consent Form.
* cognitive dysfunction that prevents the performance of evaluations or interventions,
* intolerance to the use of EPAP or BS mask
* with chronic obstructive pulmonary disease (COPD)
* cerebrovascular disease
* chronic-degenerative musculoskeletal disease
* chronic infectious disease
* in treatment with steroids, hormones or cancer chemotherapy
* hemodynamic complications (arrhythmia, myocardial infarction during the operation, with blood loss ≥ 20% of the total blood volume, defined by Mannuci, et al., 2007)
* mean arterial pressure \<70 mmHg and reduced cardiac output, requiring the use of intra aortic balloon or vasoactive drugs
* tracheal intubation for more than 12 hours after admission to the ICU or reintubated
* individuals unable to maintain airway permeability.