cyrilzakka/clinical-trials huggingface dataset:
Microalbuminuria Predicting CIAKI After CAG

The purpose of this study is to investigate the association between pre-existing microalbuminuria and contrast-induced acute kidney injury (CIAKI) following coronary angiography (CAG).


Eligibility Criteria:
Inclusion Criteria:

* Patients with eGFR≥30ml/min and without macroalbuminuria undergoing CAG.

Exclusion Criteria:

* Pregnancy
* Lactation
* Allergic history of contrast media
* Having been received contrast media within 7 days
* Use of nephrotoxic medications within 7 days
* eGFR \<30 ml/min, macroalbuminuria (ACR \>300 mg/g)
* Renal transplantation, emergent coronary angiography
* Cardiogenic shock, pulmonary edema
* Use of intra-aortic balloon pump (IABP) or mechanical ventilation
* Multiple myeloma and other malignant tumor
* Life expectancy less than 12 months
Additive Effect of Endonase on Eradication Rate of Second Line Therapy for HP Infection

Endonase, a kind of protease, is known to cause both extensive degradation of mucins and a reduction in mucus viscosity. As part of the search for more effective forms of therapy against H. pylori when it colonizes not only the surface of the surface mucosal cells but also the surface mucous gel layer covering the mucosal surface of the stomach. The investigators decided to investigate whether or not endonase might have additive effect of pronase on the efficacy of the second-line eradication therapy against Helicobacter pylori.


Eligibility Criteria:
Inclusion Criteria:

Patients with 18 years or more of age AND Patients who failed the standard proton pump inhibitor-based triple therapy for H. pylori

Exclusion Criteria:

1. Patients Under 18 years, OR
2. Patients with active peptic ulcer, OR
3. Pregnant or Breast feeding women, OR
4. Patients with gastric malignancy, OR
5. Patients with a history of drug allergy or hypersensitivity, OR
6. Patients with severe renal, liver, or heart diseases
Phase I Trial Evaluating Safety and Immunogenicity of MVA85A-IMX313 Compared to MVA85A in BCG Vaccinated Adults

This is a Phase I trial to evaluate the safety and immunogenicity of MVA85A-IMX313 vaccination compared to MVA85A vaccination, in BCG vaccinated adults.


Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all of the following criteria to enter the trial:

* Healthy adult aged 18-55 years
* Resident in or near Oxford (for CCVTM) or Birmingham (for WTCRF) and able to travel to Oxford for vaccination for the duration of the trial period
* No relevant findings in medical history or on physical examination
* Confirmation of prior vaccination with BCG not less than 6 months prior to projected trial vaccination date (by visible BCG scar on examination or written documentation)
* Allow the Investigators to discuss the individual's medical history with their GP
* Use effective contraception for the duration of the trial period (females only)
* Refrain from blood donation during the trial
* Give written informed consent
* Allow the Investigator to register subject details with a confidential database to prevent concurrent entry into clinical trials
* Able and willing (in the Investigator's opinion) to comply with all the trial requirements

Exclusion Criteria:

Subjects must meet none of the following criteria to enter the trial:

* Laboratory evidence at screening of latent M. tb infection as indicated by a positive ELISPOT response to ESAT6 or CFP10 antigens
* Clinical, radiological, or laboratory evidence of current active TB disease
* Previous vaccination with candidate vaccine MVA85A or candidate vaccine FP85A or any other recombinant MVA vaccine
* Clinically significant history of skin disorder, allergy, immunodeficiency (including HIV), autoimmune disease, cancer (except BCC or CIS), cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, neurological illness, psychiatric disorder, drug or alcohol abuse
* History of serious psychiatric condition
* Concurrent oral or systemic steroid medication or the concurrent use of other immunosuppressive agents
* History of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccine, including eggs
* Any abnormality of screening blood or urine tests that is deemed to be clinically significant or that may compromise the safety of the subject in the trial
* Positive HBsAg, HCV or HIV antibodies
* Female currently lactating, confirmed pregnancy or intention to become pregnant during trial period
* Use of an investigational medicinal product or non-registered drug, live vaccine, or medical device other than the trial vaccine for 30 days prior to dosing with the trial vaccine, or planned use during the trial period
* Administration of immunoglobulins and/or any blood products within the three months preceding the planned trial vaccination date
* Any other significant disease, disorder, or finding, which, in the opinion of the Investigator, may either put the subject at risk or may influence the result of the trial or may affect the subject's ability to participate in the trial
Clinical Study of the Safety of a Single-port Endoscopic Surgical System for General Surgery

This is a small-scale pre-clinical exploratory study to investigate the safety of a novel single-port robotic system for general surgery.

Single-incision laparoscopic surgery is a surgical procedure in which multiple laparoscopic instruments are placed through a single small incision. It has the advantages of less surgical trauma, better cosmetic results and less postoperative pain compared with conventional laparoscopic surgery. However, the technical challenges and difficulties, including loss of triangulation, parallel coaxial effect, difficulty of achieving correct exposure, shared fulcrum, lack of ergonomic favorable position, etc. limited its widespread use. Robot-assisted laparoscopic surgery have significant advantages such as minimally invasive, delicate, and flexible, which can greatly expand the surgeon's surgical capabilities and effectively solve the various problems faced by traditional surgery. Therefore, robotic assisted single-port surgery is attracting increasing attention. This study is to investigate the safety of a novel single-port robotic system for general surgery.

Eligibility Criteria:
Inclusion Criteria:

* 18 years \< age ≤75 years
* Suitable for minimally invasive surgery
* 18.5≤BMI≤28 kg/m2
* ASA score is Ⅰ-Ⅲ
* Informed consent
* Colon and rectal resection: colon and rectal polyps, inflammatory bowel disease, intestinal diverticula, colorectal cancer diagnosed cT3N0M0 with a maximum diameter of ≤4 cm located above the peritoneal reflection.
* Partial gastrectomy: gastric stromal tumor, gastric giant ulcer.
* Appendectomy: chronic appendicitis.
* Cholecystectomy: chronic cholecystitis combined with gallbladder stones, gallbladder polyps (\> 1 cm).

Exclusion Criteria:

* With other malignancies or a previous history of other malignancies
* Undergone other major surgical treatment within 3 months prior to enrolment or planned during the trial
* With active tuberculosis
* With severe systemic disease
* With long-term use of anticoagulant and anti-platelet drugs (anti-platelet aggregation drugs discontinued less than 1 week prior to surgery), history of bleeding disorders or hematopoietic or coagulation disorders.
* With severe allergies and suspected or established alcohol, drug or substance addiction
* Patients who are immunodeficiency virus (HIV) antibody positive; hepatitis B surface antigen (HbsAg) positive and have a hepatitis B virus DNA (HBV-DNA) copy number above the lower limit of detection or normal range; hepatitis C virus (HCV) antibody positive; syphilis spirochete antibody positive and at high risk of transmission as judged by the investigator.
* Emergency surgery
* Women who are pregnant, breastfeeding or planning to become pregnant during the trial
* Other conditions which, in the opinion of the investigator, make participation in this trial inappropriate.
Study on the Psychotherapeutic Treatment of Chronic Nightmares

The purpose of this study is to determine whether a change in the content of nightmares is necessary at all in the treatment of chronic nightmares or if a single confrontation with their content is sufficient to reduce nightmare frequency significantly.

The inclusion and exclusion criteria are assessed during a telephone interview. If the participants meet the criteria, they are randomly assigned to two intervention groups or an active control group. In the first session the participants who suffer from chronic nightmares are interviewed using the Structured Clinical Interview for DSM-IV (SCID-I and -II) to determine the clinical diagnosis; in addition, they are given questionnaires and record sheets to obtain baseline data. They are asked to record their nightmares in a "dream diary" up until the next session four weeks later. At that session they learn one of three interventions to reduce nightmares. The first group receives imagery rehearsal treatment in which participants learn to consciously alter the contents of their nightmares and then to visualize the new set of images. The second group is subjected to confrontation treatment in which they are instructed to confront their nightmares until habituation. The third group, the psychotherapeutic placebo group, just learn an imagination technique, without reference to their nightmares. At the end of the intervention session all participants receive written instructions on how to perform the learned method at home. They must also record their dreams up until the next session. That session and the last one are used for data acquisition. At these sessions, the participants are asked to fill in the questionnaires given to them at the beginning of the treatment.

Eligibility Criteria:
Inclusion Criteria:

* nightmare frequency of at least one night per week for six month duration
* stable medication
* if currently in psychotherapy: no treatment of nightmares
* Informed consent

Exclusion Criteria:

* Life time clinical diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder according to DSM-IV
* Body mass index \< 17
* Initiation of nightmares after taking pharmaceuticals
* Clinical diagnosis of alcohol or drug addiction according to DSM-IV
* Mental retardation
Relationship Between Immunity and Metabolism in Patients Receiving Immune Checkpoint Inhibitors for Advanced Cancer. ( RIMEC )

Recent EMA and FDA approvals have made immune checkpoint inhibitors (ICI) a standard of care in cancer treatment. ICI, used alone or as a combination are now the backbone of renal cell and lung carcinoma treatment. However, a significant proportion of patients does not respond to ICI. Thus the identification of predictive response factor is a major issue.

While factors associated with the tumour and its micro environment have been widely studied, factors associated with the patient such as metabolism could also affect the response to ICI and remain poorly studied.

The hypothesis of the investigators is that dysmetabolims, via the induction of a chronic inflammatory state could induce a defect of lymphocyte production and activation as well as a modification of the immunogenicity of tumor cells and immune cells infiltration. The consequences could be a decrease in ICI response rate as well as an increase in immune related adverse events (irAEs).

To test this hypothesis, the investigators propose a prospective bi-centric exploratory study including 60 patients treated with ICI for advanced lung or renal cell carcinoma.

The data collected will be :

* Clinical (calorimetry, impedancemetry, survey of eating habits, tumour characteristics, epidemiological data),
* Biologics (baseline and 3-months plasma bio banking for standard biology, inflammation markers TNF- α, IL1-6-8-11-17, TGF-ß, TWEAK, complement study C3, C4, C4d, CH50, C1q, CD46)

Primary objective is to assess the response to ICI depending on metabolic status.

Secondary objectives are to study the relationships between metabolism / cytokines profile/ complement profile and ICI response.

The investigators seek to generate hypotheses and to obtain exploratory data before submission of a Hospital Clinical Research Program whose objective will be to evaluate the impact of dysmetabolism on overall survival and to characterize immune and anatomopathological profiles (using DNA microarrays and flow cytometry techinques) of patients treated with ICI for renal cell or lung carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* patients ≥18 years
* patients receiving immune checkpoint inhibitors, used alone or as a combination with chemotherapy or tyrosine kinase inhibitor or other immune checkpoint inhibitor, for advanced renal cell or lung carcinoma.
* Patient Informed and signed the consent to participate in the research

Exclusion Criteria:

* patients with history of auto immune disease
* patients enrolled in an interventional study or be in the exclusion period following a previous research, if applicable
* Patient not affiliated to the social security scheme or under AME
* Patient under guardianship or curatorship or under legal protection
* Patient unable or unwilling to give written consent
* Pregnant patient

be in the exclusion period following a previous research, if applicable
Composition of Functional Tooth Units and Nutrient Intake in Older Men

Various definitions of poor dentition in older adults has been linked with inadequate intake of nutrients and poor diet quality. This study aims to look at the associations between poor dentition as defined by the composition of functional tooth units, and dietary intake of nutrients in community dwelling older men.

Poor dentition, defined by numbers of teeth, functional tooth units or edentulism has been previously shown to be associated with poor intakes of nutrients in older adults, including but not limited to vitamin C, calcium, fibre, protein, zinc and folate. Similar findings have been found when poor dentition is defined by the presence of a prosthesis. Reasons for this inverse relationship include poor denture quality, reduced chewing capacity, or the inadequacy of prosthesis to replace natural teeth.

However limited studies have looked at how the composition (natural verses prosthetic) of functional tooth units is associated with nutrient intake. A cross sectional analysis of a cohort of male older adults, participating in an ongoing longitudinal study, was conducted to investigate nutrition and oral health associations, including the relationship between the composition of functional tooth units and nutrient intake.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Moved inter or intrastate (moved out of study area)
* Death
* Refused to participate
* previously withdrawn
Survival Study in Patients Undergoing On-line Hemodiafiltration

Patients on hemodialysis will be randomly assigned (1:1) to continue on conventional hemodialysis or on-line hemodiafiltration, both three times per week. A 3 year follow-up and a sample size of around 750 will be necessary to detect a 35% reduction in mortality.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Currently undergoing hemodialysis
* Clinical stability
* Stable vascular access

Exclusion Criteria:

* Chronic inflammatory diseases
* Liver cirrhosis
* Malignancies
* Chronic immunosuppressant or antiinflammatory use
* Dialysis through temporary catheter or single puncture
Breast Lesion Analysis for Tomosynthesis Mammography

The purpose of this study is to develop a computer-aided diagnosis system to find breast lesions, including masses and microcalcifications, which hopefully will improve breast cancer detection and classification.

The purpose of this study is to develop a computer-aided diagnosis system to find breast lesions, including masses and microcalcifications, and determine if the lesion is a cancer or not for digital tomosynthesis mammography (DTM).

Eligibility Criteria:
Inclusion Criteria:

* Subjects scheduled for core biopsy of a breast lesion

Exclusion Criteria:

* Pregnant females
Continuous Hemofiltration During Cardiopulmonary Bypass and Its Effect on Lactatemia

This study aims to analyze the impact of using polysulfone membranes on continuous ultrafiltration with volume replacement in patients undergoing cardiac surgery. In this type of surgery, techniques such as conventional ultrafiltration (CUF) and modified ultrafiltration (MUF) are known for controlling the patient's fluid balance during the procedure. However, there is no scientific evidence on the benefits of continuous haemofiltration with volume replacement and its effect on lactatemia. Method and design: A single center randomized controlled trial, parallel treatment design with patient-blinded to compare outcomes in terms of the lactate clearance rates (quantity/unit of time) of the assigned therapy groups. Participants will be randomly assigned to receive the type of surgery, in order to ensure an unbiased assessment of treatments, randomisation will be performed in eight blocks of five patients. The study groups will be equivalent in all aspects except the procedures they undergo. Participants will be assigned to the first control group without haemofiltration (CG or 1) or one group with haemofiltration using a Polysulfone filter (PG or 2). Data will be collected by a blinded evaluator.

To determine whether continuous ultrafiltration with volume replacement using a polysulfone membrane during Cardiopulmonary Bypass (CPB) in patients undergoing cardiac surgery decreases intraoperative lactatemia.

Eligibility Criteria:
Inclusion Criteria:

* Patients who signed informed consent
* Patients not undergoing emergency surgery.
* Surgical procedures performed under normothermic conditions.
* Patients with a minimum time of 40 minutes before decannulation (after the end of myocardial reperfusion, unclamping of the aorta and the end of CPB).

Exclusion Criteria:

* Emergency medical condition in which it is not possible to collect study data.
* Heart condition requiring the use of hypothermia or hyperthermia during CPB.
* Patients without a minimum time of 40 minutes before decannulation (after the end of myocardial reperfusion, unclamping of the aorta and the end of CPB).
* Patients who cannot manage their fluid balance on their own through diuresis prior to CPB.
* Patients who are unable to manage excess volume during the surgical procedure by means of spontaneous or forced diuresis with diuretics (positive cumulative balance despite intravenous bolus of diuretics after 75% of the anticipated duration of CPB according to the course of the surgery).
Porcelain-fused-to-metal Versus Zirconia Implant- Supported in Mandibular Kennedy Class II

The goal of this randomized clinical trial is to compare biting force and patient satisfaction in three groups. Patients in the control group number one will receive a CoCr removable partial denture, and in the other two groups, implants will be inserted to restore missed posterior teeth (second mandibular premolar and second mandibular molar) in the span area. After three months, implants will be loaded with three units of anatomical PFM-fixed partial dentures in group number two, while in group number three, implants will be loaded with three units of anatomical Zirconia-fixed partial dentures. Biting force will be measured bilaterally at the time of delivery of the removable partial denture and delivery of fixed partial dentures after two, four, and six months. Patient satisfaction will be assessed through a quality-of life questionnaire at the six-months recall appointment

Thirty-three partially edentulous patients will be recruited. Patients will be randomly divided into three groups. Patients in the control group number one will receive a CoCr removable partial denture; in the other two groups, implants will be inserted to restore missed posterior teeth (second mandibular premolar and second mandibular molar) in the span area using a two-stage surgical technique with the help of a radiographic and surgical stent. Pre-surgical and post-surgical prescription of antibiotics, anti-inflammatory drugs, analgesic drugs, and mouthwash for one week, then a follow-up will be done at the suture removal appointment. After a three-month osseointegration period, implants will be loaded with three units of anatomical PFM-fixed partial dentures in group number two, while in group number three, implants will be loaded with three units of anatomical Zirconia-fixed partial dentures. Recall appointments will be scheduled for the patients two, four, and six months after loading for the collection of the data. Biting force will be measured using a biting force sensor for both the intact and restored sides at the time of delivery of the removable partial denture and at the loading of implants after two, four, and six months. Patient satisfaction will be assessed through a quality-of-life questionnaire at the six-months recall appointment.

Eligibility Criteria:
Inclusion Criteria:

* Kennedy Class II mandibular arch where the last standing abutment is the first premolar, opposed by a fully dentate maxilla (either natural dentition or fixed prostheses).
* A minimum of 12 millimeters of bone height above the inferior alveolar canal diagnosed from the pre-operative cone beam CT.
* Sufficient inter-arch space to accommodate the implant supported fixed partial denture.

Exclusion Criteria:

* Patients with bone or mucosal diseases.
* Heavy smokers.
* Patients with uncontrolled metabolic disorders such as diabetes mellitus.
* Patients with parafunctional habits.
* Patients with conditions that might complicate the treatment, such as: severe gag reflex, limited mouth opening.
Comparing the Effects of Exercise on the Structure and Function of Fat Tissue

Assess differences in structure and biological function of abdominal subcutaneous adipose tissue samples collected from adults who exercise regularly vs. a well-matched cohort of non-exercisers.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-40 years old
* Body Mass Index: 23-35 kg/m2
* Women must have regularly occurring menses and must be premenopausal

Exclusion Criteria:

* Evidence/history of cardiovascular or metabolic disease
* Medications known to affect lipid or glucose metabolism, or inflammation
* Weight instability ≥ ± 6 pounds in the last 6 months
* Tobacco or e-cigarette users
* Women must not be pregnant or actively lactating
* Blood pressure \> 140/90 mmHg