cyrilzakka/clinical-trials huggingface dataset:
Anticoagulation Post Laparoscopic Splenectomy

Splenic/portal vein thrombosis is an alarming complication of splenectomy. Retrospective studies in the literature have shown the incidence of symptomatic splenic/portal vein thrombosis to be between 0.7% (Rattner et al., 1993) to 8% (Winslow et al., 2002). This is a single-center, prospective, randomized study in subjects undergoing laparoscopic splenectomy. All participants will receive one dose of pre-operative low molecular weight heparin (Lovenox®) subcutaneously, 2 hours prior to surgery. Participants will be randomized pre-operatively to treatment or control group however the treatment allocation will not be revealed until the surgery is complete. Postoperatively, those assigned to the treatment group will receive 40 mg of Lovenox® subcutaneously once a day for 21 days; those in the control group will not. Patients with severe renal impairment will receive an adjusted dose of Lovenox® (30 mg subcutaneous dose daily). All patients will have a baseline abdominal Doppler ultrasound preoperatively and a second one done at 14 to 28 days post surgery to monitor for the presence of portal vein and/or splenic vein thrombosis. They will also have their lipase and liver function tests checked to correlate with the imaging findings.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo laparoscopic splenectomy at The University of Alberta or Grey Nun's Community Hospitals
* Capable of understanding the purpose and risks of the study and willing/able to sign a statement of informed consent
* Willing to undergo daily subcutaneous injections of Lovenox®

Exclusion Criteria:

* Pregnant or nursing
* Unable or unwilling to provide informed consent
* Bleeding diathesis or currently on anticoagulation therapy (i.e. coumadin, heparin, LMWH)
* Hemorrhagic cerebral vascular accident
* Severe uncontrolled hypertension
* Diabetic or hemorrhagic retinopathy
* Contradictions to anticoagulation (i.e. active GI bleed, gastric or duodenal ulcer, sustained platelet count \< 50 x103/uL, splenectomy due to trauma or history of heparin induced thrombocytopenia)
* Conversion to open splenectomy
* Allergy to Lovenox®, heparin, or other low molecular weight heparins
* Bacterial endocarditis
The Use of B-type Natriuretic Peptide (BNP) to Predict Closure of a Patent Ductus Arteriosus (PDA) in Premature Infants

A patent ductus arteriosus (PDA) is associated with increased morbidity in premature infants. Standard indomethacin treatment is associated with intestinal and renal morbidity. B-type natriuretic peptide is elevated in significant PDAs. This study will determine whether BNP guided therapy could reduce doses of indomethacin.


Eligibility Criteria:
Inclusion Criteria:

* Infants with echocardiographically confirmed PDA
* Infants determined by attending physician to require PDA closure

Exclusion Criteria:

* infants with congenital hearts disease
* infants with creatinine value \> 2.0
Phase Ia Malaria Vaccine Trial of Two Virosome-Formulated Peptides

Influenza virosomes represent an innovative human-compatible antigen delivery system that has already proven its suitability for subunit vaccine design. The aim of the study was to proof the concept that virosomes can also be used to elicit high titers of antibodies against synthetic peptides derived from the circumsporozoite protein and from the apical-membrane-antigen 1 and that the formulations are safe in humans.

Influenza virosomes represent an innovative human-compatible antigen delivery system that has already proven its suitability for subunit vaccine design. The aim of the study was to proof the concept that virosomes can also be used to elicit high titers of antibodies against synthetic peptides. The specific objective was to demonstrate the safety and immunogenicity of two virosome-formulated P. falciparum protein derived synthetic peptide antigens given in two different doses alone or in combination.

Methodology The design was a single blind, randomized, placebo controlled, dose-escalating study involving 46 healthy Caucasian volunteers aged 18-45 years. Five groups of 8 subjects received virosomal formulations containing 10 ug or 50 ug of AMA 49-CPE, an apical membrane antigen-1 (AMA-1) derived synthetic phospatidylethanolamine (PE)-peptide conjugate or 10 ug or 50 ug of UK39, a circumsporozoite protein (CSP) derived synthetic PE-peptide conjugate or 50 ug of both antigens each. A control group of 6 subjects received unmodified virosomes. Virosomal formulations of the antigens (designated PEV301 and PEV302 for the AMA-1 and the CSP virosomal vaccine, respectively) or unmodified virosomes were injected i. m. on days 0, 60 and 180.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers of both sexes, aged between 18 and 45 years, with a BMI \> 18.5 and \<30 were included if they gave written informed consent

Exclusion Criteria:

* Chronix or acute illness, immunosuppression, lived in the past in a malaria endemic area, had visited such an area in the last 12 months, or had a history of clinical malaria
Multimodal Ultrasound and Hepatocellular Response to Local Treatments

Consecutive patients with HCC who should undergo to locoregional treatments (ablation or trans-arterial chemoembolization) according to international guidelines will be enrolled. atients will undergo CEUS and SWE before and after 24 hours from the procedure as per clinical practice in our center. Subsequently, the patients will continue the normal follow-up which includes control computed tomography/magnetic resonance one month after treatment and subsequently every three months.

Primary objective: To evaluate the correlation between pre-treatment ultrasound parameters (D-CEUS and elastography) and one-month response to therapy evaluated with contrast-enhanced computed tomography.

Secondary objective: To identify quantitative ultrasound parameters able to predict overall survival and disease-free survival.

Study design: Prospective single-center study. Methods: 50 consecutive patients with HCC who should undergo to locoregional treatments (ablation or trans-arterial chemoembolization) according to international guidelines will be enrolled in the Unit of Internal Medicine and Gastroenterology of the Policlinico Gemelli. After obtaining informed consent and identifying the target lesion in B-mode ultrasound, patients will undergo CEUS and SWE before and after 24 hours from the procedure as per clinical practice in our center. Subsequently, the patients will continue the normal follow-up which includes control computed tomography/magnetic resonance one month after treatment and subsequently every three months. In addition, the personal, clinical and laboratory data necessary to determine the hepatological scores of disease severity such as MELD and Child-Pugh will be collected. The study has an expected duration of one year.

Eligibility Criteria:
Inclusion Criteria adult patients with single nodule hepatocellular carcinoma detectable with B-mode ultrasound and scheduled for locoregional treatment

Exclusion Criteria:

* liver failure
* previous treatments fo hepatocellular carcinoma
* chronic or acute heart failure
* known ipersesitivity to ultrasound contrast agent
* pregnancy and lactation
Study of the Utility of the BOMET-QOL Questionnaire Patients With Breast Cancer and Bone Metastasis

Epidemiological, prospective and multicenter study to evaluate the utility of the BOMET-QoL questionnaire in patients with breast cancer (BC) and bone metastases (BM).

Population: Patients over 18 with breast cancer and bone metastasis.

Inclusion criteria:

* Patient over 18 years of age.
* Patient diagnosed with breast cancer (BC) and bone metastases (BM).
* Patient who has granted informed consent in writing to participate in the study.
* Patient capable of understanding and completing the questionnaires.

Exclusion criteria:

* Patient with another type of disease that, in the investigator's opinion, could mask the study results.
* Patients with a life expectancy of less than 8 months.
* Patient who is participating in a clinical trial with an unregistered drug at the start of the study.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age.
* Patient diagnosed with BC and BM.
* Patient who has granted informed consent in writing to participate in the study.
* Patient capable of understanding and completing the questionnaires

Exclusion Criteria:

* Patient with another type of disease that, in the investigator's opinion, could mask the study results.
* Patients with a life expectancy of less than 8 months.
* Patient who is participating in a clinical trial with an unregistered drug at the start of the study.
Acute Responses of Postural Alignment, Kinematic Synergy, and Intermuscular Coherence to Postural Muscle Facilitation

Clinicians frequently assess and intervene on postural alignment. However, research demonstrating the effects of exercise interventions in moving postural alignment toward an evidence-based standard is lacking. Part of the difficulty in establishing such evidence has been a lack of theory-motivated conceptions of what "good" posture is. In other words, the prevailing understanding of postural alignment is based on the negation of what has been observed to associate with bad outcomes. This study will build upon preliminary findings from our laboratory that define good postural alignment on theoretical grounds. The investigators will measure motion capture and muscle activation patterns during simple postural alignment tasks before and after 1) a corrective exercise intervention, or 2) a control intervention based designed to inhibit superficial muscle tension. The corrective exercise intervention is designed to counteract the natural patterns in which the human skeleton tends to collapse from a standing position under the influence of gravity. The control intervention consists of passive, partner-assisted stretching. Regardless of initial assignment, all participants will crossover (i.e. switch interventions) and repeat the study procedures after a 1-week washout period. Behavioral indicators of movement and nervous system coordination will be used to quantify alignment before and after exercise, as well as the consistency of those alignment patterns with theoretically-defined standards. The knowledge gained from this study will contribute to evidence-based definitions of healthy postural alignment and help identify effective interventions by which clinicians can promote good posture.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult
* 18 - 40 years of age

Exclusion Criteria:

* Recent (\< 6 months) history of lower extremity injury
* Recent (\< 6 months) history of other musculoskeletal or neurological disorder affecting balance
* Contraindications to participation in physical activity
Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells

This phase 1, single-center, open-label study explores the safety of escalating doses of chimeric antigen receptor T cells (CAR-T) cells in subjects with relapsed/refractory triple-negative breast cancer (TNBC).

T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (iC9-CAR.B7-H3 T cells) treatment is experimental and has not been approved by the Food and Drug Administration. The safety of iC9-CAR.B7-H3 T cells will be investigated using a modified 3+3 design. The data from the dose escalation will be used to determine a recommended phase 2 dose (RP2D), which will be decided based on the maximum tolerated dose (MTD) and additional factors such as the ability to manufacture sufficient cells for infusion.

Subjects with TNBC who meet procurement eligibility criteria will have cells collected to manufacture iC9-CAR.B7-H3 T cells. Eligible subjects will receive lymphodepletion with cyclophosphamide and fludarabine.

Eligibility Criteria:
Inclusion Criteria:

Unless otherwise noted, subjects must meet all of the following criteria to participate in in all phases of the study:

1. Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information explained to, understood by and signed by the subject or legally authorized representative.
2. Age ≥ 18 years at the time of consent.
3. Karnofsky score of \> 60% (see APPENDIX VI- Karnofsky Scale))
4. Histologically confirmed TNBC (ER-, PR-, HER2-negative)

   1. ER- and PR-negative: defined as \< 1% staining by immunohistochemistry (IHC)
   2. HER2-negative: defined as IHC 0-1+ or fluorescence in situ hybridization (FISH) ratio \< 2.0

Exclusion Criteria:

1. Patients with a history of symptomatic CNS involvement or multiple metastases requiring whole-brain radiation.
2. Subjects with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
3. Subject does not have a measurable and or evaluable disease as defined by RECIST 1.1
Effectiveness of Synagis (Palivizumab) Immunoprophylaxis in Preterm Infants With High Risk of Severe Respiratory Syncytial Virus (RSV) Infection

Published data by the Organización panamericana de la Salud shows that Peru's mortality rate from acute respiratory infections (ARI) in infants less than one year of life is second only to Haiti (14,150/100,000). Government data reports shows a marked increase of RSV infections in Peru. "Instituto Nacional de Salud" (Peru's National Institute of Health) reports between January 1st to February 26th 2006, 62% of their positive samples corresponded to RSV. Epidemiological data from Lima-Peru, demonstrates that there is no specific season for RSV infection although some data suggest an increase in RSV activity during cold months (May to September; INS data). Clinical studies show that giving five doses of Synagis (palivizumab) resulted in serum concentrations \> 30 ug/mL for \>20 weeks. The aim of this post-marketing observational study is to determine the RSV hospitalization rate in high-risk infants who received Synagis (palivizumab) through the Social Security Hospitals in the context of routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Receiving Synagis (palivizumab) immunoprophylaxis during respiratory syncytial virus season, according to the usual clinical practice:
* Infants born \< or = 32 weeks of gestation and are younger than 6 months of age at the beginning of the respiratory syncytial virus season.
* Children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months, until the first year of life.
* Children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment).

Exclusion Criteria:

* Major congenital malformation aside from congenital heart disease
* Chronic pulmonary disease other than bronchopulmonary dysplasia
* Active infections
* Contraindication to Synagis
* Receipt of another immunoglobulin preparation including but not restricted to polyclonal intravenous immunoglobulin, cytomegalovirus hyperimmunoglobulin (Cytogam), or respiratory syncytial virus hyperimmunoglobulin (Respigam).
* Any other condition that according deemed an obstacle for study conduction or representing an unacceptable risk by the participating investigator.
Aromatherapy Protocol for Pain Reduction in Hospice Patients

The purpose of this study is to introduce aromatherapy with current pain medication protocols to see if it improves patient satisfaction and reduces pain in hospice care patients.


Eligibility Criteria:
Inclusion Criteria:

* currently on hospice at Seasons Assisted Living

Exclusion Criteria:

* pain level not 3/10 or higher
PERCI- Medium Cut Off (MCO)

The medium cut-off dialysis membrane has been developed to provide a significantly extended molecular cut-off compared to conventional high-flux membranes. The medium cut-off membrane allows for a high permeability of molecules up to a molecular weight of 45 kDa and has a still limited permeability for albumin (68 kDa).

The main goal of this project is the evaluation of the new, highly porous and selective dialysis membrane (MCO-Ci 400) for the treatment of patients with end-stage renal disease in hemodialysis mode and to study its potential to improve chronic inflammation.


Eligibility Criteria:
Inclusion Criteria:

* CKD5 ( GFR \< 15ml/min/ 1.73m2)
* Dialysis treatment for ≥ 3 months
* Dialysis 3x weekly
* Vascular access by fistula or CVC
* Age \> 18 and \< 99 Years
* Ability to give written informed consent

Exclusion Criteria:

* Missing informed consent form
* current clinically manifested infection or within the last two weeks
* current CRP-value \> 50mg/L or within the last two weeks
* Intake of any medication applied for immunosuppressive purposes
* Pregnancy or lactation
* Participation in a different interventional study
Real World Observational Study of Poteligeo in Adult Patients With MF and SS (PROSPER)

This is a prospective, observational, non-interventional, international, multi-center, mixed methods study that will involve the integration of quantitative and qualitative data in patients with MF/SS treated with Poteligeo.

The PROSPER study aims to collect information about the experiences of patients with MF/SS receiving Poteligeo and of their caregivers in real-world clinical practice. The objective of this study is to generate patient-level data to provide insights into real world clinical practice and an understanding of treatment decisions, as well as to collect patient reported outcomes (PRO) data, enriched with qualitative data on disease and treatment experience and burden, to demonstrate the full impact of treatment and the relevant patient experience in real-world clinical practice. The study will be conducted 6 countries, including North America, United Arab Emirates and countries in Europe, at 19 sites known to treat and follow-up patients with MF/SS. Patients will be followed for up to 50 weeks from study enrollment.

Eligibility Criteria:
Inclusion Criteria:

1. Patient aged ≥18 years
2. Confirmed diagnosis of MF/SS
3. Disease staging at enrollment has been completed
4. About to commence primary treatment with Poteligeo® as per reimbursed indication
5. Patient is willing and able to complete the symptom diary and PROs.
6. Patient is willing and able to provide written informed consent to participate in the study in a manner approved by Institutional Review Board(IRB)/ Independent Ethics Committee (IEC) and local regulations

Exclusion Criteria:

1. Patient unable to participate in all aspects of the study and/or does not agree to the collection of data from medical records
2. Patient currently participating in an interventional clinical trial
Prevalence of Sexual Addiction in an Inmate Population at the Muret Detention Center in Haute-Garonne (PAS-CD)

Sexual addiction, also known as hypersexuality or compulsive sexuality, is a human sexual behavior that results in a continuous and persistent search for sexual pleasure. Replacing the former terms satyriasis and nymphomania, the World Health Organization (WHO) ICD-11 has referred to this disorder as "compulsive sexual behavior disorders".

From multiple causes (iatrogeny, neurological causes, psychiatric causes, psychopathological hypotheses), but still only partially known, the inclusion of this disorder among impulsivity-related disorders, obsessive-compulsive disorders or addiction-related disorders is still debated in the scientific literature. Thus, in the absence of sufficient robust scientific data, DSM-5 refused to include this disorder in its classification.

However, the consequences of this disorder on the psychosocial functioning of individuals are not negligible, which can go as far as the precipitation of a transition to an heteroaggressive act which can thus lead to incarceration.

The prevalence of this disorder in the general population is estimated between 2 and 6% based on current literature data. This rate appears to be higher among men and more specifically among sex offenders.

However, some authors have noted that the difficulty in determining a clear prevalence of sexual addiction may be related to the still poorly defined diagnostic criteria for this disorder as well as the choice of measurement tools.

In the inmate population, to our knowledge, there are no French prevalence studies of this disorder. In addition, no studies have been conducted to compare the prevalence of sexual addiction among sex offenders (SASO) with that among non-sex offenders (SANSO).

We hope that better screening for addiction would enable better management of patients with this disorder, promoting their psychosocial rehabilitation and well-being, so as to prevent the recurrence of a transition to sexual arousal.

This study is intended to assess the prevalence of sexual addiction among a population of detainees at the Muret detention center in Haute-Garonne.

Eligibility Criteria:
Inclusion Criteria:

* Male subjects
* Detainees at Muret Detention Center
* Aged between 18 and 65 at the time of the search
* And having agreed to participate in the research.

Exclusion Criteria:

* Person under legal protection, guardianship or curatorship ;
* Insufficient command of the French language
* Existence of cognitive disorders preventing a good understanding of the information relating to the study or the various questionnaires.
Frequency and Characteristics of Pruritus in Patients With Monoclonal Gammopathy

Pruritus is most often secondary to dermatitis but can also occur without skin lesions, it is called pruritus sine materia. The causes of pruritus sine materia are various: haematological (myeloproliferative neoplasia ...), hepatic (cholestasis ...), renal (chronic renal failure, dialysis), endocrine (iron deficiency ...), secondary to drug intake ... or idiopathic when no cause is found.

Gammapathies are among the causes of pruritus sine materia, and as such electrophoresis of serum proteins is usually part of the pruritus assessment to look for monoclonal gammopathy (MGUS, multiple myeloma, Waldenström disease). However, there is very little data on the frequency of pruritus in patients with monoclonal gammopathy and the characteristics of this pruritus. So the aim of this study is to compare the frequency of pruritus between patients with monoclonal gammapathy and controls


Eligibility Criteria:
Inclusion Criteria for case :

Major patient Realized Serum protein electrophoresis between 2014 and 2017 Hematology follow-up at Brest CHR Positive monoclonal gammopathy Non-opposition formulated

Inclusion Criteria for Control :

Major patient Realized Serum protein electrophoresis between 2014 and 2017 Hematology follow-up at Brest CHR Negative gammopathy Non-opposition formulated

Exclusion Criteria:

Minor patient Major protected Patient with another haemopathy secreting a monoclonal immunoglobulin (lymphoma, LLC ...) Physical or mental incapacity Refusal to participe