cyrilzakka/clinical-trials huggingface dataset:
Comparison Between Vacuum Drain and Passive Drain In Abdominoplasty

The aim of the present study is to:

Compare the subcutaneous collection with Vacuum Drain and Passive Drain insertion at abdominoplasty surgery


Eligibility Criteria:
Inclusion Criteria:

* • Cooperative male and female patients aged between 20-60 years old.

  * All patients in the study presented with varying degrees of excess abdominal skin and adipose tissue, along with a range of underlying abdominal muscle laxity, following volumetric changes of the abdominal cavity.
  * These patients may undergo after bariatric surgery, dietry weight loss or after multiple pregnancies.

Exclusion Criteria:

* • Uncooperative patients unwilling to give consent.

  * Those unsuitable for abdominoplasty surgery, BMI \>30 and those on antiplatelet medication.
  * Unfit for surgery and patients with allergies to any of the anesthesia components.
Persistent Pain After Cystectomy for Bladder Cancer

This single-center, cross-sectional survey and sensory examination is conducted to determine the prevalence, sensory characteristics and risk factors of PPSP in patients who underwent cystectomy at Washington University/Barnes-Jewish Hospital between 2009 and 2015. Based on data from other lower abdominal surgeries, the investigators hypothesize that 10-15% of patients undergoing cystectomy will develop PPSP.

Currently, open radical cystectomy (ORC) with urinary diversion is the standard treatment for patient with muscle-invasive organ-confined bladder cancer. ORC involves the complete resection of local metastatic disease and reconstruction of a functional urinary tract. Additionally, minimally invasive laparoscopic surgery was shown to be safe alternative to open radical cystectomy. A total of 29,719 patients underwent a form of cystectomy in the United States between 2009 and 2011. Both cystectomy procedures require a midline incision on the pubic symphysis, and as with virtually any surgical incision, it produces tissue injury and inflammation, which result is acute post-operative pain.

Acute pain after surgery typically subsides with tissue healing; however, some patients go on to develop persistent post-surgical pain (PPSP). It is estimated that 21-52% of people who had underwent thoracotomy, 21.5-47.3% of women who had breast surgery, and 4.7%-18% of people who had underwent abdominal surgery developed PPSP. The incidence of the condition varies substantially by the type of surgical procedure, which is also an important factor affecting the mechanism of PPSP. For example, while thoracic surgeries result in predominantly neuropathic pain due to intraoperative nerve injury, in hysterectomies and knee replacement surgeries the mechanisms of PPSP seem to be predominantly inflammatory. However, no data are currently available on the prevalence or potential mechanisms of PPSP after cystectomy.

Understanding the prevalence, risk factors, and the potential mechanisms underlying PPSP after cystectomy will serve the basis for investigating approaches for risk stratification and prevention of PPSP in bladder cancer patients undergoing the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18;
* Cystectomy for bladder cancer performed at Washington University/Barnes-Jewish Hospital between Jan 1, 2009 and June 30, 2015.

Exclusion Criteria:

Surveys will not be sent if any of the following criteria exist:

* Patient is deceased or has moved out of the United States.
* Preoperative record indicates multiple surgeries in the abdominopelvic region.
Pharmacokinetic Study of SYP-0704A and Taxotere to Treat Patient With Advanced Solid Cancer

Primary Objective: Evaluation of the pharmacokinetic equivalence of two Docetaxel formulations in terms of AUC and Cmax.

Comparison of pharmacokinetic parameters (T1/2β, CL, Vdss) Safety as measured by adverse events

Eligibility Criteria:
Inclusion Criteria:

* Subjects who aged 18 years or older.
* Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial.
* Subjects who have histologically or cytologically confirmed advanced solid tumor.
* Subjects who are a suitable candidate for single agent docetaxel therapy for their advanced solid tumors that have failed to standard therapy.
* Subjects who have fully recovered from reversible toxic effects of prior therapy. The prior chemotherapy, immunotherapy, hormone therapy, surgery, and/or radiotherapy should be completed at least 21 days before the first administration of investigational product.

Exclusion Criteria:

* Subjects who have had a major surgery other than tumor ablation within 2 weeks prior to the screening/baseline visit.
* Subjects who have a history of metastasis or currently have a metastasis to the central nervous system (CNS).
* Subjects who have a preexisting sensory or motor neuropathy of grade ≥ 2 based on NCI CTCAE V3.0.
Comparison Between the Expected Site of Sacral Hiatus by Conventional Method and the Real Site by Ultrasonography for Caudal Block in Children

Caudal block is one of the most useful and popular regional block in pediatric anesthetic practice. Successful caudal block depends on the proper placement of a needle through sacral hiatus by following anatomical landmarks. The sacrum and the position of sacral hiatus are extreme variable anatomical structure. Generally, the equilateral triangle located between the apex of the sacral hiatus and posterior superior iliac spines is used in determining the location of the sacral hiatus as the conventional method. Previous study demonstrated that the triangle formed between the apex of the sacral hiatus and the posterior superior iliac spines was found to have the features of an equilateral triangle in adult. There is no study about the efficacy of the conventional method using the equilateral triangle in children. In this study, the investigators will compare between the expected site of sacral hiatus by conventional method using the equilateral triangle and the real site of the sacral hiatus confirmed by ultrasonography for caudal block in children.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 0-72 months
* patient whho are scheduled to undergo elective inguinal herniorraphy under general anesthesia

Exclusion Criteria:

* The history of prematurity
* he histories of the infection, tumor, and operation in sacrum 3. The history or suspicion of meningomyelocele
Feasibility of a Self-management App for People With Knee Osteoarthritis (OA-AID Feasibility Study)

In this feasibility trial, an 8-week digital intervention including remote monitoring in patients with knee osteoarthritis (OA) will be tested. The app will provide information on osteoarthritis and recommended treatment for people with knee OA.

In this feasibility study various outcome measures will be assessed to determine whether the app (Genus) is viable, practical, and useful.

The study will test the feasibility of an 8-week digital intervention including remote monitoring prior to consultation in specialist healthcare. The app consist of information on osteoarthritis and recommended treatment for people with knee OA. A total of 20 patients referred to Diakonhjemmet Hospital due to knee OA will be recruited to the study. The study will include assessments of technical, operational, clinical, and trial aspects of feasibility. Data will be collected through digital questionnaires (through the app or Nettskjema), through interviews and from medical records. Primary outcome is the feasibility of the app after 8 weeks. Additionally, the feasibility of the study process until consultation in specialist healthcare will be assessed.

The aim of the app is to improve patients' health literacy and enhance the shared decision-making process between patient and healthcare provider at the consultation in specialist healthcare.

Eligibility Criteria:
Inclusion Criteria:

* Men and women =\>50 years of age
* Referred to specialist healthcare for knee OA management

Exclusion Criteria:

* Received joint replacement or are under consideration for revision in the referred joint
* Have uncontrolled serious comorbidities
* Have cognitive dysfunction
* Are seeking care for trauma conditions or psoriatic/rheumatoid arthritis
* Unable to understand Norwegian
* Do not have a smartphone
Preventing Chronic Disease: ActuaYa

The purpose of the study is to help older Hispanic women to increase physical activity, reach a healthy body weight, increase self-esteem and mood and increase knowledge about chronic diseases such as hypertension, diabetes, and HIV.


Eligibility Criteria:
Inclusion Criteria

1. Must self-identify as a Hispanic woman
2. Must be aged 50 years or older
3. Must not already be engaging in exercise for \>150 minutes per week
4. Must be able to ambulate without the use of assistive devices
5. Must have an intelligent phone iOS or Android
6. Must be willing and able to participate in the informed consent process.

Exclusion Criteria

1. Participants that do not meet the above-mentioned criteria.
2. In the opinion of the investigator, have any clinical condition that would make the participant unsuitable to participate.
3. Participants who are currently participating in another investigational study.
4. Participants that need a medical clearance for exercise based on the American College of Sports Medicine exercise participation algorithm.
Evaluation of Non-Ablative Laser for Treatment of Direct Brow Lift Scars

The purpose of this study is to determine the efficacy of the 1064nm Neodymium yttrium aluminum garnet (Nd:YAG) laser (Laser Genesis, Cutera TM) in the treatment of surgical scar after direct brow lift.

Patients who undergo a direct brow lift may participate in this study. Participants will receive laser treatment on one of the two surgical wounds (side of treatment will be chosen randomly by an independent source). Treatment parameters will be 500 spots and 10-14 megajoules (mJ) depending on skin type. The opposite side brow scar will not be treated until 1 month after the study is completed (if the patient elects to treat the contralateral brow after study completion this will be done at no charge to the patient). This treatment will be given at 2-4 week intervals for 6 treatments. Photographs will be taken at each visit, and they will be assessed based on different parameters by an examiner, as well as judged by the patient based on overall appearance.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing or have undergone direct brow lift

Exclusion Criteria:

* under 18 years old
* history of photodermatoses
* receiving systemic isotretinoin within the preceding 6 months
* undergoing other scar treatment in the brow area
* pregnant patients
* history of adverse outcomes related to non-ablative laser
French Lumbar Total Disk Replacement Observational Study

Primary Objective:

To evaluate the rate of re-operation during the first 5 years following the fitting of lumbar total disk replacement at the operated level and / or floors above and / or underlying, whatever the reasons

Secondary objectives:

The secondary objectives are:

* Describe the reasons for re-interventions operated floor and / or (x) level (s) adjacent (s)
* Describe the evolution of the function with the functional Oswestry score
* Describe the evolution of lumbar radicular pain by visual analog scale (VAS)
* Describe the evolution of the quality of life assessed by the SF12 score
* Describe the evolution of work status
* Describe patient satisfaction
* Describe the complications (intraoperative, early postoperative (within 3 months of surgery), late, death)

Eligibility Criteria:
Inclusion Criteria:

* Patient who needs, according to his surgeon, a PTDL placement and has given his consent for the PTDL placement
* Patient who agrees to participate in the observational study after information by the surgeon
* Patient living in France and having the ability to respond alone to the questionnaire

Exclusion Criteria:

* None
A Dose-escalation Pharmacokinetic Study of Intravenous ASA404 in Adult Advanced Cancer Patients With Impaired Renal Function and Patients With Normal Renal Function

The purpose of this study is to evaluate the safety and pharmacokinetics of ASA404 in patients with refractory or relapsed metastatic cancer with impaired renal function and with normal renal function. It is very possible that patients with renal impairment will show differences in renal excretion of parent ASA404 and its metabolites, warranting a study that leads to a better pharmacokinetic assesssment in this population.


Eligibility Criteria:
Inclusion Criteria:

* Patients having histologically-proven solid tumors, who are either refractory to standard chemotherapy;
* Patients whom chemotherapy with an investigaional agent in combination with docetaxel, or paclitaxel + carboplatin is appropriate;
* Creatinine clearance according to Cockcroft-Gault formula : Normal \> 80 mL/min, Mild 50-80 mL/min, Moderate 30-\<50 mL/min;
* A minimum of 4 weeks must have elapsed since the last treatment with other cancer therapies;
* Potassium, calcium, magnesium and phosphorus values within the normal range;
* Body Mass Index (BMI) must be within the range of 18 and 30

Exclusion Criteria:

* Patients having CNS metastases, must have a CT or MRI of the brain performed to rule out CNS metastases;
* Patients with leptomeningeal disease metastases;
* Radiotherapy \</- weeks prior to starting study drug;
* Major surgery \</ 4 weeks prior to the start of study;
* Administration of CYP1A2 and CYP3A4/5 enzyme inducing or inhibiting drugs within 14 days prior to starting study drug;

Other protocol-defined inclusion/exclusion criteria may apply
Psychological Symptoms in Cardiac and Pulmonary Diseases

The European guidelines emphasize the importance of conducting psychological screenings to investigate the presence of stress and symptoms of anxiety and depression in patients with cardiovascular disease: depression, common among patients with CVD, is associated with increased mortality, disability, decreased adherence to healthy lifestyles and medical treatments, and together with anxiety, the risk of mortality increases by about 3 times; stress, furthermore, is associated with the development and progression of cardiovascular diseases and is correlated with low adherence and cigarette smoking.

Less studied, but not less important, are the incidence of anxiety, depression, and stress in pulmonary disease, the relationship between mental disorders and pulmonary diseases, as well as the effect of the psychological component on the rehabilitative outcome of such patients: for example, there is evidence that those suffering from chronic obstructive pulmonary disease (COPD) present symptoms of depression and anxiety much more frequently than the general population and that these two mental disorders may exacerbate COPD itself.

The literature, therefore, highlights that the risk of onset of cardiovascular disease increases with the severity of mental disorder, and some psychological variables correlate with the outcomes of cardiac rehabilitation intervention, crucial for reducing rehospitalizations, myocardial infarction, and mortality, as well as for improving the patient's quality of life and ability to perform physical exercises.

In light of this evidence and the recent recommendations of the ESC, the present study aims to conduct screening for symptoms of anxiety, depression, and stress in all patients admitted to the Cardiology and Pulmonary Rehabilitation Units of the Milan Center, Camaldoli in order to assess their incidence and to select, through validated tools, patients who require personalized psychological intervention based on their level of risk, correlating then the presence of such symptoms with the rehabilitative outcome, in order to assess how much the mental component interferes with the care pathway. The level of acceptance and feasibility of a computerized data collection procedure will also be evaluated, a procedure that, if well accepted, would make the screening process much simpler, safer, and more economical.


Eligibility Criteria:
Inclusion Criteria:

* aged≥18
* able to fulfil questionnaires autonomously

Exclusion Criteria:

* no Italian comprehension,
* severe visuoperceptive deficits,
* cognitive deterioration preventing self-completion of questionnaires,
* refusal to underwent to the evaluation
Evaluation of 3APS in Patients With Mild to Moderate Alzheimer's Disease

The purpose of this Phase III study is to evaluate the efficacy and safety of 3APS compared to placebo (inactive substance pill) in patients with mild to moderate Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

Patients may be included in this study if they meet all of the following criteria:

* Male or Female (age 50 years and older): Female must be of non-childbearing potential (i.e. surgically sterilized or at least 2 years post-menopausal).
* Diagnosis of probable Alzheimer's disease based on the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA criteria).
* Severity of dementia of mild to moderate degree as assessed by the Mini Mental State Examination (MMSE) performed at the screening visit.
* Patient must be living in the community with a reliable caregiver. Participant living in an assisted living facility may be included if study medication intake is supervised and participant has a reliable caregiver.
* Potential participant must be treated with conventional Alzheimer's disease therapies and must be on stable dose for at least 4 months prior to the screening visit and during the entire study period.
* Fluency in English, French or Spanish (oral and written).
* Signed informed consent from potential participant or legal representative and caregiver.

Exclusion Criteria:

Patients will not be eligible to participate in the study if they meet any of the following criteria:

* Potential participant with any other cause of dementia.
* Life expectancy less than 2 years.
* Potential participant with a clinically significant and/or uncontrolled condition or other significant medical disease.
* Use of an investigational drug within 30 days prior to the screening visit or during the entire study.
* Previous use of 3APS.

Patient recruitment is done by participating centers.
Safety and Immune Response of Different Pediatric Combination Vaccines.

The overall aim of the study is to corroborate that a schedule consisting of 3 doses of Pentacel™ and a 4th dose of DAPTACEL® and ActHIB® or 4 doses of Pentacel™ or 4 doses of Quadracel and ActHIB® is as safe and immunogenic as a standard of care schedule based on 3 doses of the licensed-equivalent vaccines DAPTACEL®, Vero cell derived Inactivated Poliovirus vaccine (IPOL®), and ActHIB® and a 4th dose of DAPTACEL® and ActHIB®.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 42 days and ≤ 89 days on the day of inclusion
* Born at full term of pregnancy (≥ 36 weeks)
* Informed consent form signed by the parent(s) or other legally authorized representative(s) before the 1st study related procedure
* Vaccination with a hepatitis B vaccine at least 30 days before inclusion
* Able to attend all scheduled visits and to comply with all trial procedures(i.e., access to a phone)
* Provide blood sample prior to Dose 1
* Parent or legal representative willing to take rectal temperatures after each vaccination.

Exclusion Criteria:

* Participation in another clinical trial in the 4 weeks preceding the (first)trial vaccination
* Planned participation in another clinical trial during the present trial period
* Personal or immediate family history of congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
* Known or suspected systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the trial vaccine(s)
* Chronic illness that could interfere with trial conduct or completion
* Received blood or blood-derived products since birth
* Any vaccination in the 2 weeks preceding the first trial vaccination or planned in the 4 weeks after any trial vaccination. Flu vaccine could be administered only 2 weeks after any trial vaccination
* Previous vaccination with any acellular pertussis- (DTaP) or whole cell pertussis- (DTwP) based combination vaccines, Haemophilus influenzae type b (Hib)-conjugate, poliovirus, or pneumococcal conjugate vaccines
* Coagulation disorder contraindicating intramuscular (IM) vaccination
* Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion)
* Developmental delay or neurological disorder
* Any condition which, in the opinion of the investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.
The Influence of Thiopurine Methyltransferase Activity on Toxicity After High-dose Methotrexate in Childhood Acute Lymphoblastic Leukemia

The purpose of this study is to explore the impact of thiopurine methyltransferase (TPMT) activity on the risk of HDM-related bone marrow- and hepatotoxicity and treatment interruptions during maintenance therapy for children with ALL.

Hypothesis of the study: Patients with TPMT activity compatible with TPMT low activity polymorphisms have an increased risk of toxicity following high-dose methotrexate (HDM) compared to children with normal TPMT activity.

High-dose methotrexate (HDM) given concurrently with oral 6-mercaptopurine (6MP) may be followed by myelotoxicity, which may necessitate treatment interruption and thus interfere with the efficacy of the treatment of childhood ALL. Several studies have indicated that MTX and 6MP act synergistically. It has previously been reported that the risk of significant bone-marrow suppression is increased if oral 6MP is coadministered with HDM during maintenance therapy and that reductions of the dose of concurrently given oral 6MP can reduce the risk of significant myelotoxicity following HDM. MTX may increase the bioavailability of 6MP through inhibition of xanthine oxidase, which catabolizes 6MP. In addition, MTX may through inhibition of de novo purine synthesis enhance the availability of 6-thioguanine nucleotides (6TGN) that primarily exert the cytotoxic effect of 6MP.

The enzyme TPMT competes with the formation of 6TGN, as it methylates 6MP and thus create relatively non-toxic metabolites. TPMT heterozygous patients with one wild type and one low-activity allele have a higher risk of myelosuppression and treatment interruption compared to patients with TPMT wild type. Furthermore, TPMT heterozygous patients have a reduced risk of relapse and a higher risk of secondary malignancy compared to patients with TPMT wild type.

Little has been published on the influence of both TPMT activity and 6MP dosage on myelo- and hepatotoxicity following HDM.

Eligibility Criteria:
Inclusion Criteria:

* included in the NOPHO ALL92 protocol
* available TPMT phenotype
* treated at least once with HD-MTX 5.0 g/m2 (+- 10%) during maintenance therapy
* at least one available measurement on blood counts or alanine aminotransferase levels 28 days after HD-MTX

Exclusion Criteria:

* HR ALL
* children with Down Syndrome
* Events during maintenance therapy
* TPMT deficiency