cyrilzakka/clinical-trials huggingface dataset:
Search Elevated Serum Alkaline Phosphatase as a Marker of Prenatal Intervillositis Chronic Histiocytic

Background : Chronic histiocytic intervillositis is a rare placental disease linked with poor perinatal outcome. In a recent study, a major antenatal increased alkaline phosphatase was suspected in patients affected by chronic histiocytic intervillositis. This increase may correspond to the release of alkaline phosphatase by the syncytiotrophoblaste prejudiced in this pathology.

Aim : To confirm the association between high levels of alkaline phosphatase and the occurrence of chronic histiocytic intervillositis.

Single-center study of case-control comparing three groups of patients matched for gestational age at the time of sampling. The case group will be composed of patients who experienced chronic histiocytic intervillositis which an alkaline phosphatase assay is available during pregnancy (retrospective recruitment). Two control groups will be prospectively: The first will include patients whose pregnancy is low risk. The second will consist of pathological pregnancies (IUGR, Preeclampsia and Death In Utero). All patients will have a blood sample with determination of serum alkaline phosphatase activity and examination of the placenta at delivery.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years or more
* Having signed a free and informed consent
* Enjoying a social security scheme

Inclusion criteria for cases:

* Patient who gave birth at the Lille University Hospital between 2000 and 2009.
* Lesion of intervillositis chronic histiocytic (IHC) diagnosed during histological examination of the placenta.
* An alkaline phosphatase assay during pregnancy is available and has been achieved at University Hospital of Lille.
* Prior information and not opposition of the patient to the secondary use of data collected in medical file.

Inclusion criteria for low-risk pregnancy :

* No pathological obstetric history, no current pregnancy complications
* Followed antenatal clinics at the Lille University Hospital
* A gestational age corresponding to one of the cases (pairing ± 1 week)
* No chronic intervillositis after pathological examination of the placenta

Inclusion criteria for high-risk pregnancy:

* Patient hospitalized in the maternal-fetal pathology of the Lille University Hospital Service
* Presence of IUGR, Death in Utero or severe preeclampsia with fetal repercussion
* A gestational age corresponding to one of the cases (pairing ± 1 week)
* No chronic intervillositis after pathological examination of the placenta

Exclusion Criteria:

* Twin pregnancy
* Liver disease in the interrogation
* Lack of consent of the patient
* Patient not covered by a social security scheme
* Patient minor
* Patient under guardianship
Efficacy and Safety of Teicoplanin in CDAD

Primary Objective:

Explore the efficacy of teicoplanin (100-200 mg administered orally twice a day for 7 to 14 days) in patients with Clostridium difficile infection-associated diarrhea and colitis

Secondary Objective:

Evaluate the safety of teicoplanin in patients with Clostridium difficile infection-associated diarrhea and colitis

Approximate 10 weeks

Eligibility Criteria:
Inclusion criteria :

* Signed Informed Consent.
* Male or female no less than 18 years of age.
* Inpatient with a diagnosis of mild-moderate or severe CDAD (first occurrence or first recurrence within 3 months) with: Diarrhea: a change in bowel habits with \> 3 liquid or unformed bowel movements (UBM) within 24 hours prior to enrollment, AND Positive C. difficile toxin test on a stool sample produced within 72 hours prior to enrollment.

Exclusion criteria:

* More than one previous episode of CDAD in the 3-month period prior to enrollment.
* Evidence of life-threatening or fulminant CDAD.
* Likelihood of death within 72 hours from any cause.
* History of inflammatory colitides, chronic abdominal pain, or chronic diarrhea
* Antimicrobial treatment active against CDAD administered for \> 24 hours except for metronidazole treatment failures (MTF).
* Known hypersensitivity or contraindication to teicoplanin.
* Pregnant or nursing females.
* Unable or unwilling to comply with all protocol requirements.
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Characterization of the Toll-like Receptor 7-agonist Imiquimod 3.75% As a New Surrogate Model of Itch

The aim of this research project is to design a new model of human itch by application of Zyclara cream. Further, the aim is to characterize the model and to verify if the mechanism of action of imiquimod follows the histaminergic or non-histaminergic pathway by using the anti-histamine drug doxepin. The last goal is to evaluate the interaction between the activation of TLR7 receptor and the activation of TRPA1 and TRPM8 receptors, which are two of the most important receptors involved in the transduction of noxious stimuli, and to evaluate to which extent these three channel populations functionally overlap.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* 18-60 years
* Speak and understand English

Exclusion Criteria:

* Pregnancy or lactation
* Drug addiction defined as any use of cannabis, opioids or other drugs
* Previous or current neurologic, musculoskeletal or mental illnesses
* Lack of ability to cooperate
* Current use of medications that may affect the trial
* Skin diseases
* Consumption of alcohol or painkillers 24 hours before the study days and between these
* Acute or chronic pain
* Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)
Dorsal Penile Nerve Block for Rigid Cystoscopy in Men

This study will determine the effectiveness and safety of dorsal penile nerve block (DPNB) in men undergoing rigid cystoscopy.

Pain is common in men undergoing rigid cystoscopy. Even with application of a lubricant containing 2% lidocaine, about 76% men suffer from mild to severe pain when undergoing rigid cystoscopy, and approximately 27% men could still feel mild to moderate pain 7 days after the procedure. The most painful part of the procedure for men is when the cystoscope passes through the membranous urethra. Song et al did autopsy on males found dorsal nerve of the penis (DNP), the terminal branch of the pudendal nerve, innervates the membranous urethra in 53.3% specimens. In addition, urethral mucosa has branches of DNP innervated. Dorsal penile nerve block (DPNB) is usually used for circumcision in children and it has been shown to provide effective analgesia for penile surgeries. According to the evidence that some DNP branches innervate membranous urethra and urethra mucosa and most pain originates from cystoscope passing through membranous urethra, we speculated that DPNB could overall reduce pain level in men during rigid cystoscopy.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) Physical Status I-II
* Without history of urethral or prostatic surgery
* Without respiration or circulation disorders
* Without chronic pain

Exclusion Criteria:

* Allergy to local anesthetics
* Coagulation disorder or usage of antiplatelet drugs
* Infection at the site of puncture point
* Severe urethral stenosis
Clinical Evaluation of EUS-FNA on Diagnosis of Pancreatic Cystic Lesions

It is still controversial about the necessity of endoscopy ultrasound guide fine needle aspiration (EUS-FNA) on diagnosis of pancreatic cystic lesions(PCL).The aim of this study is to find the influence of EUS-FNA on diagnosis and suggestions of EUS specialists.

First, the investigators will send only EUS images of patients with PCL to diagnosis committee that is consisted with 8 EUS specialists from different countries.The diagnosis will be collected. Then the investigators send the results of EUS-FNA. The diagnosis and suggestions will be collected again. The investigators will calculate how much diagnosis has been changed because of results of EUS-FNA. The investigators will also follow up these patients for 5 years at least to find if these patients benefit from EUS-FNA and complications such as needle tract seeding metastases.

Eligibility Criteria:
Inclusion Criteria:

1. Adults with ages from 18-80 years old.
2. The patients with pancreatic cystic lesions, which diameter of cystic lesion more than 2cm.
3. Sign the informed consent voluntarily. -

Exclusion Criteria:

1. The patient can't accept the endoscopic procedure.
2. The patient has blood coagulation dysfunction.
3. The patient has mental disorders.
4. The patient has mild or severe cardiorespiratory insufficiency.
5. The patient has hypertension and can't be controlled to safe level.
6. Patients with alcohol dependence.
7. Pregnant and lactating women.
8. The patients the investigators don't think suitable for this study.

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PCI in Advanced Triple Negative Breast Cancer Patients Who Response to 1st Line Chemotherapy

The purpose of this study is to compare whether prophylactic cranial irradiation in patients with advanced triple negative breast cancer who had a response to first line chemotherapy could prolong brain-metastasis free survival.

This is a phase III, randomized, controlled, open, multicenter clinical trial, designed to assess the efficacy and safety of prophylactic cranial irradiation (PCI) in advanced triple negative breast cancer who response to the first line chemotherapy. Compare the PCI group with the observation group to evaluate brain metastasis-free survival,cumulative risk of brain metastases within 1 year,progression-free survival,overall survival,quality of life measured by the The Europe organization for research and treatment of cancer, Quality of life Questionnaire-cancer 30 (EORTC-QLQ-C30) questionnaire score and function of central nervous measured by the The Europe organization for research and treatment of cancer, Quality of life Questionnaire-brain cancer 20 (EORTC-QLQ-BN20) questionnaire score in women with advanced triple negative breast cancer who response to the first line chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent;
2. Age of 18 to 65 years;
3. Documented advanced breast cancer, clinical and pathological confirmed;
4. Immunohistochemical examination:ER\<1%+, progestin receptor (PR)\<1%+, HER-2 -/+ or HER-2(++)with negative result of FISH;
5. A response after four to eight cycles of first line chemotherapy;
6. Life expectancy longer than six months evaluated by investigator;
7. A performance status of 0 to 2, according to the criteria of the World Health Organization (with a higher score indicating a poorer performance status)
8. Less than grade 1( Common Terminology Criteria grade version 4.0) of treatment-related toxicities;
9. Adequate baseline organ function.

Exclusion Criteria:

1. History of another malignancy.
2. Pregnancy or gestation
3. Definite diagnosed of central nervous system (CNS)or leptomeningeal metastases
4. Serious cardiac illness or medical condition
5. Known history of related central nervous system or leptomeningeal disease
6. Cognition impairment or suffering from mental illness
7. Demand a long-term oral administration of psychotropic drugs
8. Have a concurrent disease or condition that may interfere with study participation, or any serious medical disorder that would interfere with the subject's safety (for example, active or uncontrolled infection, currently active/requiring anti-viral therapy hepatic or biliary disease)
Influence of Social Determinants of Health on the Management of HCC in the French National Cohort Study CHIEF

With 8,000 related deaths per year, HCC is one of the most dangerous cancers in France. The main reason for the poor prognosis of HCC is most often a diagnosis at an advanced stage ineligible for curative treatment. In the field of oncology, low participation to screening is closely linked to socioeconomic status (e.g. level of education, income, employment). In HCC, the socioeconomic status is linked to incidence, overall survival and treatment allocation in US, UK and Australia. This suggests that the social environment should be taken into account when designing interventions and policies that allows facilitating the medical pathways for patients with HCC with the ultimate goal of improving the overall prognosis. However, the studies assessing the impact of social determinants on the management of HCC in France are limited. Bryère at al. reported that the highest incidence and the worst prognosis of HCC were observed in the most disadvantaged populations in France. To date, there is no available data concerning the influence of social determinants on: implementation of surveillance programs of HCC, stage of disease at the time of diagnosis or treatment allocation. This data is essential for better understanding the geographic disparities observed in France and for developing the strategies to remedy them.

CHIEF is a multicenter longitudinal observational study of patients with HCC (ClinicalTrials.gov Identifier: NCT04348838), that will collect the exhaustive data including patient and tumor characteristics, diagnostic circumstances and modalities, care pathway from diagnostic imaging to referral to expert center, treatment allocation and implementation, and 5-year follow up including recurrent assessment of quality of life.

Social-CHIEF is an ancillary study to the CHIEF cohort (approved by CHIEF scientific committee). The population of this study will consist in a subset of patients from the CHIEF prospectively included or already recruited who accept to participate in this study. The data collected in CHIEF will be retrieved from the CHIEF main database and additional data about social determinants will be specifically investigated by self-administrated questionnaires. The results obtained will provide a better understanding of the influence of social determinants on health trajectories of HCC patients. These data will be essential in recommending new health policies and in designing innovative intervention studies to address social disparities.


Eligibility Criteria:
Inclusion Criteria:

* Patients already included in the French national CHIEF cohort who accept to participate in the Social-CHIEF study.

Exclusion Criteria:

* Patients included in CHIEF cohort who opposed to participate in the Social-CHIEF study.
Effect of Serenity Therapy on Symptoms Distress, Coping Styles, and Emotional Regulation Among Geriatric Patients Undergoing Hemodialysis: a Randomized Controlled Trial

Our research aims to examine the effect of the serenity therapy on symptoms distress, coping styles, and emotional regulation among geriatric patients undergoing hemodialysis. This study highlights the following question: what is the effect of the serenity therapy on symptoms distress, coping styles, and emotional regulation among geriatric patients undergoing hemodialysis.

In order to conduct this study, a randomized controlled trial research design was followed. The selected sitting for this study was the hemodialysis unit of the National Medical Institute at Damanhur city, El-Behaira Governorate, Egypt. Geriatric patients who were recruited for this study, meet the following inclusion criteria; being sixty years or more, scheduled for two or three weekly hemodialysis sessions for a minimum of three months, and having previously undergone hemodialysis for at least six months.

Eligibility Criteria:
Inclusion Criteria:

* Being sixty years or more
* Scheduled for two or three weekly hemodialysis sessions for a minimum of three months
* Having previously undergone hemodialysis for at least six months.

Exclusion Criteria:

* having kidney transplant or peritoneal dialysis, hearing or vision disorders that could impede communication, previous participation in serenity therapy program, and getting psychiatric or psychosocial treatment
Pulmonary Rehabilitation in Interstitial Lung Diseases

Treatment in interstitial lung diseases (ILD) is frequently ineffective. Pulmonary rehabilitation (PR) is an excellent therapeutic option in another chronic lung diseases such as chronic obstructive pulmonary disease (COPD). This prospective randomized controlled study aims to evaluate the short and long-term effects of PR in patients with ILD. For this purpose, 60 ILD patients will be randomly assigned to a PR or a control group.

The investigators hypothesize that PR will improve exercise capacity, increase muscle force, reduce dyspnea and improve quality of life and daily life activities in ILD patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of interstitial lung disease according to internationally established criteria
* Dyspnea on exertion
* Stable medical therapy
* Stable clinical condition at inclusion, with no infection or exacerbation in the previous 4 weeks

Exclusion Criteria:

* Co-morbidities that do not allow exercise training (unstable angina, recent myocardial infarction or cerebrovascular accident, active cancer, severe orthopedic disorders).
* Life expectancy below 3 months
Long-term, Non-interventional, Observational Study Following Treatment With Fate Therapeutics FT500 Cellular Immunotherapy

Subjects who previously took part in the FT500-101 study and received allogeneic NK cell immunotherapy will take part in this long term follow-up study. Subjects will automatically enroll into study FT-003 once they have withdrawn or complete the parent interventional study.

The purpose of this study is to provide long-term safety and survival data for subjects who have participated in the parent study. No additional study drug will be given, but subjects can receive other therapies for their cancer while they are being followed for long term safety in this study.

This is a multicenter, non-interventional, observation study designed to provide long-term safety and efficacy data on subjects who have participated in a prior Fate Therapeutics interventional study of FT500 cellular immunotherapy. Subjects will be contacted every six months (± one month), beginning six months after subject completion or withdrawal from the FT500-101 study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who received an allogeneic, iPSC-derived NK cell in a Fate Therapeutics interventional study
* Subjects who have provided Informed consent prior to their study participation

Exclusion Criteria:

* Not Applicable
A Pilot Study of Sorafenib Examining Biomarkers in Refractory or Relapsed T-Cell Lymphoma Patients

This study will be a pilot study of sorafenib 400mg PO twice daily in refractory T-cell lymphomas including peripheral T-cell lymphoma (PTCL), angioimmunoblastic lymphadenopathy (AILD), cutaneous T cell lymphoma (CTCL), anaplastic large cell lymphoma (ALCL) and other transformed T-cell lymphomas with the primary objective of studying the biological effects of the multikinase inhibitor, sorafenib.

Primary objectives:

• To study the biological effects of sorafenib 400mg BID on the mitogen-activated protein kinase (MAPK) pathway, specifically the inhibition of extracellular signal-regulated kinases (ERK) phosphorylation, and to correlate with clinical activity in patients with T-cell lymphoma.

Secondary objectives:

* To observe the clinical activity of sorafenib 400mg BID by determining response rate, and progression free survival in patients with T-cell lymphoma. Duration of response and duration of stable disease will also be measured.
* To determine the tolerability of sorafenib in patients with T-cell lymphoma.

Exploratory objectives:

* To observe the effects of sorafenib on T-cell subsets (CD4/CD8 ratio, and Tregs), and the effects of sorafenib on the monocytoid population.
* To observe the effects of sorafenib on the serum cytokine profile.
* To observe the effects of sorafenib on the T-cell receptor pathway, i.e. Lck, ZAP-70, and Syk.
* To observe changes in lymph node or skin morphology including tumor cell infiltrate, vasculature, and the tumor microenvironment in patients treated with sorafenib by performing serial biopsies of lymph nodes or skin.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed T-cell lymphoma including PTCL, AITL, CTCL, ALCL (Alk+, and Alk-), and other transformed T-cell lymphomas
* Age \> 18 years old
* Measureable disease, as defined by the Cheson criteria
* ECOG Performance Status of 0 or 1
* Life expectancy \> 12 weeks
* Adequate bone marrow, liver and renal function
* Patients with hemoglobin \< 8.5g/dL, or ANC 500-1000/mm3, or platelets 50,000-75,000/mm3 (Grade 3), whose cytopenias are due to bone marrow involvement by T-cell lymphoma will also be eligible

Exclusion Criteria:

* Prior treatment with sorafenib, or other agents with similar activity, i.e. bevacizumab, imatinib, sunitinib.
* Prior treatment with allogeneic stem cell transplant
* Cardiac disease: Congestive heart failure \> class II NYHA.
Prospective Snapshot Audit of Distal Pancreatectomy in Spain

Distal pancreatectomy is the surgical technique performed to treat many pancreatic diseases located in neck and tail of the pancreas. Laparoscopic approach is the gold standard but in many centres the percentage of laparoscopic approach is still low. This technique has low mortality but 30% morbidity mostly related to pancreatic fistula. Some new devices (linear stapler, energy devices and patches) seem to decrease pancreatic fistula but there is not evidence based medicine that confirm the results published usually in unicentric studies.

Snapshot observational study including most of the Spanish pancreatic units that perform distal pancreatectomy. One year consecutive cases.

Main objectives.

1. percentage of laparoscopic approach in Spain
2. Morbidity at 90 days measured by CCI and Clavien Dindo
3. Percentage of pancreatic fistula
4. Impact of new device to decrease pancreatic fistula

Eligibility Criteria:
Inclusion Criteria:

-All distal pancreatectomies performed in involved Units

Exclusion Criteria:

* No sign of informed consent for entering in the study
* Emergency procedures