cyrilzakka/clinical-trials huggingface dataset:
Health Data Warehouse on Aortic Insufficiency

This project aims to create a data warehouse based on care data of patients with an aortic insufficiency admitted to the Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL) since 2011.

The aim is to enable the utilisation of this data for research purposes.

All eligible patients will be informed about the collection of their data during their care at the Valvulopathies Center of Groupement des Hopitaux de l'Institut Catholique de Lille (GHICL). Their consent will be needed for the inclusion.

Data will be collected exclusively by the person responsible for implementing the data processing and his/her authorised staff. For all patients, data will be collected retrospectively, based on medical records (electronic or paper), and information available on the various care software linked to the patient's file. There will not be changes in the the patient's care.

At the GHICL Valvulopathy Centre, in accordance with European recommendations, patients with aortic insufficiency are monitored as follows, depending on the severity of the pathology:

* Minimal aortic insufficiency: follow-up every 3-5 years (approximately) including clinical examination and transthoracic echocardiogram (TTE)
* Moderate/medium aortic insufficiency: follow-up every 1-2 years with clinical examination, laboratory tests and TTE.
* Significant aortic insufficiency: follow-up every 6-12 months including a clinical examination, a biological assessment and a c+/- TTE coupled with an exercise test.
* Cardiac Magnetic Resonance Imaging (MRI) indicated as a second-line procedure after TTE in cases of moderate/medium aortic insufficiency with arguments or doubts about an underestimation of the severity of the aortic insufficiency on TTE, aortic insufficiency of undetermined quantification on TTE, or significant aortic insufficiency on TTE to confirm the severity using a multiparametric approach.
* TEE (transesophageal echocardiogram) is indicated as 2nd line after TTE in cases of significant aortic insufficiency as part of the preoperative work-up or moderate/undetermined aortic insufficiency on TTE.

The choice between cardiac MRI or TEE, or both, as second-line treatment after TEE, is left to the clinician in current practice, in accordance with the recommendations.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age \>= 18 years)
* Cared for at GHICL Since 1st January 2011
* With chronic aortic insufficiency of any grade.

Exclusion Criteria:

* Patients who have undergone prosthetic aortic valve surgery prior to diagnostic transthoracic echocardiography
* Patients with acute heart failure
* Patients with an intracardiac shunt or other complex congenital heart disease or obstructive hypertrophic cardiomyopathy
* Patients with aortic prosthesis
* Patients with active endocarditis or sequelae \< 6 months old
* Patients under legal protection
* Patient who refused to take part in the study
* Patients with other than minimal left heart valve disease (with the exception of secondary mitral insufficiency)
A Study to Compare PK, Immunogenicity and Safety of Trastuzumab of Incepta Pharmaceuticals Ltd With Trastuzumab (Roche)

Trastuzumab is an Ig G1 kappa, humanized monoclonal antibody which is most abundant subclass of IgG, that works against overexpress of HER2 (Human Epidermal Growth Factor Receptor Type 2). Trastuzumab is used to treat HER2-positive breast, gastroesophageal, and gastric cancers. HER2 regulate cell growth and survival, as well as adhesion, migration, differentiation and other cellular response. But when HER2 signaling is over expressed it causes uncontrolled cell growth which leads to the formation of cancerous tumor.

In this study, healthy adult male volunteers will receive a single intravenous administration of Trastuzumab (Incepta) or Trastuzumab (Roche) according to randomization. During the course of the study, the pharmacokinetics will be assessed by sampling the levels of the drug in the blood and by comparing these levels among the different administration arms. Safety and immunologic response will also be evaluated throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male participant, age 18 to 55 years old
* BMI 18.5 to 30.0 weight in kg/height in meter2; BMI value should be rounded off to one significant digit after decimal point. Volunteer having body weight at least 50 Kg.
* Non-smokers and non-tobacco user (i.e. having no past history of smoking and tobacco consuming for at least one year prior to study)
* Able to understand procedure, agree to participate and willing to give informed consent.
* Willing and able to comply with the study procedures, restrictions and requirements as judged and confirmed by the principal investigator
* Male subjects, if married, must agree that they and their spouse will use adequate contraception or be of non-childbearing potential.

Exclusion Criteria:

* Have significant diseases or clinically significant abnormal findings during screening \[medical history, physical examination, vital signs, laboratory evaluations, ECG, Echocardiography (LVEF less than 55%)\]. Any disease or condition like diabetes, psychosis or others which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, ophthalmic, pulmonary, metabolic, endocrine, immunological, respiratory, central nervous system or any other body system.
* History of and/or current cardiac disease
* Neutrophil count less than the lower limit of normal range during screening.
* A positive hepatitis screen (includes subtypes B \& C).
* Use of hematopoietic growth factors, monoclonal antibodies or immunoglobulins within last 6 months prior to the study medication administration.
* History of any cancer, including carcinoma in situ
* Volunteer with history of angina, dyspnea, orthopnea, congestive heart failure or myocardial infarction
* Have received live vaccine(s) within 30 days prior to Screening or who will require a vaccine(s) between Screening and the End of Study visit.
* History or evidence of drug abuse or of alcoholism or of moderate alcohol use.
Nutritional Supplementation in the Elderly With Weight Loss

Many elderly experience weight loss and weakness with normal aging. Although there is extensive literature regarding nutritional advice for the elderly, there are few well- designed studies evaluating the effect of oral nutrition supplements in patients with weight loss and aging. The aim of this study is to examine the effect of dietary prescription with or without nutrition supplementation that includes soy protein, whey protein and fish oil in elderly patients who have suffered unintentional weight loss.

This is an 8-week, randomized, pilot study with elderly subjects (age 65 and older) with recent unintentional weight loss who will receive either two servings of supplement powder and fish oil or no dietary supplementation (N=10 for each group).

Eligibility Criteria:
Inclusion Criteria:

* Male or female age 65 and older
* Non-smokers
* Weight loss \>3% body weight over 6-12 months
* BMI ≤ 25
* Living independently or in an assisted living facility

Exclusion Criteria:

* Medical conditions that would lead to weight loss

  * Active cancer undergoing treatment (chemotherapy, radiation therapy, or planned surgical intervention)
  * CKD stage IV-V (eGFR \<30) based on medical records within the last 12 months
  * Presence of dysphagia or odynophagia
  * Actively taking blood thinner such as Warfarin
  * Known history of cirrhosis with presence of ascites
  * History of a surgical procedure for weight loss (e.g. gastroplasty, gastric bypass, gastrectomy or partial gastrectomy, lap-band)
  * Any abnormal lab findings outside of normal limits as determined by the investigator
* Dietary conditions

  * Diet restrictions including vegetarianism, veganism, soy-free diet,
  * Fish and/or fish oil allergy or intolerance
  * Milk allergy excluding lactose intolerance
  * Follows a kosher diet
* Medications

  * Use of appetite stimulants (including megestrol, dronabinol and cyproheptadine).
  * Does not include medications used for depression (e.g. mirtazapine, paxil) if patient has been on a stable dose of this medication for at least 3 months prior to the start of this study
  * If participant is already taking a fish oil supplement, he/she must be willing to either stop the supplement or take the supplement the investigators are using in the study depending on the randomization assignment
* Additional

  * Patient has implantable device such as a pacemaker or ICD
  * Unable to complete 6-minute walk test at baseline
  * Hospitalization within the last 30 days
  * Participation in a therapeutic research study within 30 days of baseline
  * Living in a skilled nursing facility or long-term care facility
  * Any other medical condition that principal investigator or co-investigators deem would preclude the patient from study participation
A Study of CD19/22 CART Cells Combined With PD-1 Inhibitor in Relapsed/Refractory B-cell Lymphoma

This is a single center, non-randomized, open-label, phase 2 study to evaluate the efficacy and safety of CD19/22 CART cells combined with PD-1 Inhibitor in relapsed/refractory B Cell Lymphoma.

Though response rates have greatly improved with the development of Chimeric antigen receptor T cells (CART) therapy in refractory/relapsed B cell non-Hodgkin's lymphoma (R/R B-NHL), the response can't usually last long and relapse occurs in a large proportion of patients who receive CART cells infusion. The main reasons of relapse might be tumor antigen loss and a lack of CART cell persistence. Currently, preclinical studies have shown that there is a synergistic effect between CAR-T cell therapy and anti-PD1 pathway, and it did have efficacy in clinic. In parallel, the combined use of CART-19 and CART-22 cells has a better potential to reduce antigen escape and increase anti-tumor activity. Therefore, the combination of CD19/22 CART and PD-1 inhibitor is one of the ways to improve the therapeutic effect of CART cells. This study was conducted to explore the efficacy and safety of CD19/22 CART cells in R/R B-NHL.

Eligibility Criteria:
Inclusion Criteria:

1. R/R B-NHL with measurable (≧1.5cm) lesions confirmed by pathological immunohistochemistry or flow cytometry ( meeting any of the following conditions):

   A.The lesion shrinkage \<50% or disease progression after 4 courses of standard first-line treatment or 2 courses of two-line treatment (primary refractory disease) B. Progress disease as the best response after hematopoietic stem cell transplantation C.Progress disease or stable disease as the best response to most recent therapy regimen
2. Age ≥ 18 years
3. The Eastern Cooperative Oncoloy Group (ECOG) physical condition score ≤ 2 points
4. The main organ functions need to meet the following conditions:

   A.Left ventricular ejection fraction ≥50% B.Creatinine ≤132umol/l or creatinine clearance ≥60 ml/min C.ALT and AST≤2 upper limitation of normal D.SpO2 \> 90%
5. Results of pregnant test should be negative, and agree to conception control during treatment and 1 year after CAR-T infusion
6. Expected survival exceeds 3 months
7. Written informed consent could be acquired

Exclusion Criteria:

1. Immunosuppressant medications or steroids was used within 2 weeks before cell collection, or need to use steroids or immunosuppressant medications more than two years
2. Uncontrolled bacteria, fungi, viruses, mycoplasma or other types of infection
3. Active hepatitis B or hepatitis C infection
4. HIV infection
5. Severe acute or chronic graft-versus-host disease (GVHD)
6. Participated in any other drug research clinical trials within 30 days before enrollment
7. Prior CART cells therapy within 3 months before enrollment
8. Prior allogeneic hematopoietic stem cell transplantation within 6 months before enrollment
9. Have contraindications to the PD-1 inhibitors
10. Uncontrolled other tumor
11. Women in pregnancy,lactation or planning to become pregnant
12. The researcher considers inappropriate to participate in this research
Ceftolozane-Tazobactam for Directed Treatment of Pseudomonas Aeruginosa Bacteremia and Pneumonia in Patients With Hematological Malignancies and Hematopoietic Stem Cell Transplantation

This is an open-label study, where participants will be given ceftolozane-tazobactam as the primary treatment for Pseudomonas aeruginosa infections. Open-label means both the investigator and the participant will known what drug will be given. Participants will be followed for approximately 60 days. Ceftolozane-tazobactam is approved by the Food and Drug Administration (FDA) for treatment of serious bacterial infection and the investigator hypothesizes that ceftolozane/tazobactam may be effective as the primary antibiotic treatment for Pseudomonas aeruginosa infections.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Presence of hematologic malignancy or Hematopoietic Stem Cell Transplantation
* Identification of Pseudomonas aeruginosa by rapid molecular diagnostic assay from a blood culture or from a respiratory sample in the setting of radiologically documented pneumonia and clinical symptoms compatible with pneumonia.

Exclusion Criteria:

* Anaphylactic hypersensitivity or allergic reaction to cephalosporins
* Participants with expected mortality within 48 hours
* Hemodialysis or continuous renal replacement therapy, or creatinine clearance \<15 ml/min
* Prior non-study anti-pseudomonal therapy for \>72 hours
* History of a strain of Pseudomonas aeruginosa with MIC \>4 microgram/ml to ceftolozane/tazobactam
* Polymicrobial aerobic Gram-negative infection as determined by ID research team

Patients who completed this study and subsequently experience a separate, recurrent Pseudomonas aeruginosa infection, may be re-enrolled into this study if all eligibility criteria are met.
Improved Detection of Neonatal Sepsis Using a Targeted Biomarker Assay

The purpose of this study is to determine whether analysis of specific serum biomarkers will improve the diagnosis of late onset neonatal sepsis and to determine the correlation between plasma levels of specific cytokines and bacteremia in NICU patients \>3 days of age.

All infants in the Newborn Intensive Care Unit greater than three days old that had blood cultures sent were eligible for this study. Left-over blood from the time at blood culture was collected for research purposes. Study personnel separated the serum and stored samples at -80 degrees until analysis. Samples were analyzed in batch for neonatal sepsis biomarkers using an antibody-coated microsphere assay with dual laser detection. Clinical information collected included symptoms prompting the blood culture, CBC and culture results, and antibiotic therapy.

Eligibility Criteria:
Inclusion Criteria:

* NICU patients \> 3 days of age

Exclusion Criteria:

* less than 3 days old or no waste blood available
Forced Diuresis Versus Observation in Resolving Renal Failure After Haemofiltration in Critically Ill Patients

Intensive care patients with multiple organ dysfunction syndrome often show renal failure with the need for hemofiltration. Resolving renal failure after cessation of hemofiltration may or may not be accompanied by oliguria. Whether or not the administration of diuretics at that moment is appropriate is not known. The study randomises between furosemide or placebo when hemofiltration is stopped. Study endpoint is recovery of renal function.

Introduction:

Virtually all intensive care (IC) patients with prolonged IC stay have multiple organ dysfunction syndrome. Frequently renal failure is present. The resolution of renal failure is often relatively late. After cessation of hemofiltration, oliguria may be present, at least for some time. Increasing diuresis by diuretics will probably increase clearance. As a result, intensive care stay and outcome may improve. However, diuretics might also be harmful as it is when applied in developing renal failure.

Aim of the study:

To study whether the stimulation of diuresis by furosemide when hemofiltration is stopped enhances renal recovery and secondary shortens the length of IC-stay.

Setting:

IC-patients treated at the Medical Centre Leeuwarden with MODS and renal failure are included when hemofiltration is stopped. The ICU is mixed medical and surgical, 16 beds with full time intensivists responsible for hemofiltration.

Study design:

Prospective randomised placebo controlled single centre trial.

Methods:

Inclusion criteria. Patients with mechanical ventilation in whom hemofiltration is stopped. Written informed consent must be obtained.

Excluded are patients with pre-existent serum creatinin of 150 umol/l or clearance less than 30 ml/min. Patients admitted with renal failure as the primary admission diagnosis in case acute renal failure is due to glomerulonephritis.

Creatinin clearance is measured in a 4 hour period directly after cessation of hemofiltration. The patient is then randomised for furosemide or sodium chloride. Furosemide is administered at 0.5 mg/kg/hour. Dehydration is prevented by infusing the patient the volume of their diuresis.

Daily creatinin clearance is calculated.

Primary endpoints:

1. Recovery of renal function (clearance more than 30 ml/min)
2. Stable or declining serum creatinin in case of persistent clearance less than 30 ml/min
3. Need for re-start of renal replacement therapy (metabolic acidosis, hyperkalaemia, fluid overload, uremia or uremic complications)

Secondary endpoints:

Length of stay ICU, mortality.

Poweranalysis:

36 patients per group for alpha 0.05 and beta 0.8 and 30% faster recovery of renal failure for the intervention group.

Statistical analysis:

Student t for normally distributed variables, otherwise non-parametric tests. Kaplan Meier and Cox regression for time to recovery of renal function.

Eligibility Criteria:
Inclusion Criteria:

* cessation of hemofiltration
* mechanical ventilation
* written informed consent

Exclusion Criteria:

* pre-existent renal failure
* glomerulonephritis
A Novel Protocol for Labour Induction

The use of foley catheter was tested many times and proved to be effective for induction of labour.

The investigators compare between vaginal misoprostol versus foley catheter plus vaginal isosorbide mononitrate (IMN) for induction of labour

Eligibility Criteria:
Inclusion Criteria:

* Term or post term pregnancies.
* Live,singleton fetus.
* Cephalic presentation.
* Intact membrane.
* Bishop score \< 6.
* Not in labour.
* Medically indicated for labour induction.
* Primigravida or parity of 3 or less.

Exclusion Criteria:

* Previous caesarean delivery.
* Malpresentation.
* Placenta previa.
* Sever intrauterine growth restriction.
* Multiple pregnancy.
* Polyhydramnios.
* Oligohydramnios.
* Bishop score 7 or more.
Chios Mastic Toothpaste and Halitosis and Oral Hygiene in Orthodontic Patients

The aim of this trial was to investigate the effect of mastic toothpaste on halitosis using as proxy the levels of the Volatile Sulfur Compounds (VSCs), and the effect on plaque and gingival indices in adolescents undergoing orthodontic treatment with fixed conventional labial appliances.


Eligibility Criteria:
Inclusion Criteria:

Patients eligible for the trial must comply with all of the following at randomization:

• Age between 13 and 18 years for the group with conventional orthodontic appliances.

This age group represents the majority of patients seeking orthodontic treatment and is homogeneous regarding occupational status (high-school and lyceum students in Greece). Younger patients might present with cooperation problems.

* Good general health.
* Orthodontic fixed labial appliances on the maxillary and mandibular arch, brackets at least on 20 teeth for more than 4 months before enrollment and estimated duration of the treatment more than 1 month, bands on the first molars, extraction cases patients could be enrolled at least two months after the last extraction.
* Total initial VSCs levels above the baseline level of 150ppb.

Exclusion Criteria:

Patients will be excluded for any of the following reasons:

* Active caries
* Periodontitis
* Dental fluorosis / dysplasia of the teeth
* Syndromes, mental disabilities and craniofacial deformities
* Smoking or use of other tobacco products
* Allergy to mastic
* Antibiotics during the last 2 months
* Chlorhexidine in the previous 3 weeks
* Participation in other trials
Impact of Albendazole -Ivermectin on Wuchereria Bancrofti in Mali

Lymphatic filariasis is a public health problem in Mali. The existing data are not up to date and most of them are more than 15 years old. To address this issue in April 2000, the investigators started studies to update the epidemiology of lymphatic filariasis. There is no ongoing lymphatic filariasis control program in 2000 in Mali in terms of preventive chemotherapy treatment or vector control.

To fill these gaps, this current study aims to assess the impact of albendazole-ivermectin combination treatment on Wuchereria bancrofti infection and transmission in 6 rural highly endemic villages of Mali.

Lymphatic filariasis is a public health problem in Mali. The existing data are not up to date and most of them are more than 15 years old. To address this issue in April 2000, the investigators started studies to update the epidemiology of lymphatic filariasis. As a result, in two rural areas (Banambani and Sirakoro) located at about 25 km North-East Bamako, the parasite prevalence using ICT cards in August 2000 were 16% (n=150) and 15.0% (n=113) respectively in Banambani and Sirakoro. There is no ongoing lymphatic filariasis control program in 2000 in Mali in terms of preventive chemotherapy treatment or vector control.

To fill these gaps, this current study aims to assess the impact of albendazole-ivermectin combination treatment on Wuchereria bancrofti infection and transmission in 6 rural highly endemic villages of Mali.

The study will be conducted in three phases: the pre treatment assessment of lymphatic filariasis infection and transmission parameters, treatment phase with annual single dose of albendazole and ivermectin and the post treatment assessment of Anopheles gambiae s.l mosquitoes, the transmission parameters of the vectors in the community, human infection prevalence post treatment using Giemsa -stained thick smears and others test like the Immuno chromatographic test (ICT).

Eligibility Criteria:
Inclusion Criteria:

* resident of the 6 villages
* 5 years and above

Exclusion Criteria:

* pregnant women
* breastfeeding women