cyrilzakka/clinical-trials huggingface dataset:
Periodontal Therapy in Patients With Rheumatoid Arthritis

Aim: A prospective randomized, controlled clinical trial comparing two groups of a cohort of Rheumatoid Arthritis (RA) patients with periodontal disease will be carried out to identify if the effect of non-surgical periodontal therapy is a predictor of remission/ low disease activity (LDA)-remission.

Methods: 42 patients with RA and periodontitis from the RA Almenara cohort will be included (ACR 1987 and or ACR/EULAR 2010 criteria with more than 16 years old at diagnosis); those with \<6 teeth, current infections, cancer or oral precancerous lesions, diabetics, Sjogren's syndrome, use of antibiotics or drugs associated with dry mouth and dental surgery, will be excluded. Periodontal Disease was defined by the presence of periodontitis stage 3 or 4 with at least 2 non-adjacent teeth with insertion loss \>=5mm, probing depth \>=5mm and bleeding on probing according with the 2018 periodontitis diagnostic criteria.

Two RA patients groups will be follow up by monthly visits. Patients will be divided into two groups (intervention and no intervention treatment). PD treatment will be performed by a qualified periodontist. No intervention group will receive PD treatment after 6 month visit because ethical principles. Disease activity will be determined according with DAS 28index, Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) scores, C-reactive protein (CRP), the erythrocyte sedimentation rate (ESR), and rheumatoid factor levels will be registered before and after PD treatment (baseline, 3 and 6 months visits), and the differences between the groups will be analyzed and compared. Periodontal parameters including probing depth (PD), clinical attachment loss, and sulcus bleeding index (SBI) will be correlated with the factor levels.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes
* Age ≥16 years at the time of diagnosis and who do not meet criteria of overlap with any other autoimmune disease.
* Presence of six or more permanent teeth in the mouth, excluding third molars.
* Presence of periodontitis stage 3 or 4 with at least 2 non-adjacent teeth with insertion loss \>=5mm, probing depth \>=5mm and bleeding on probing according to Tonetti et al.\[35\].
* Willingness to attend all visits for the duration of the study.

Exclusion Criteria:

* Patients with Sjogren's syndrome

  * - Severe ongoing systemic infection.
  * - Associated dental infection
  * - History of oral cavity cancer or precancerous lesion.
  * - Use of local or systemic antibiotics in the last 3 months (including tetracyclines or other medication that could change the periodontal evaluation in the investigator's opinion, such as heparin alendronate, antivitamin K).
  * - Medications that induce gingival hyperplasia (such as phenytoin, warfarin or cyclosporine).
  * - Pregnant or breastfeeding women
  * - Participation in another intervention study.
  * Patients with a history of PD treatment in the last 6 months or previous dental surgery)
Heart Transplant and Primary Transplant Dysfunction: a Retrospective Analysis of the Strasbourg Experience

Among the complications of heart transplant, primary dysfunction of the graft (PDG) is the most feared with a net impact on early morbidity and mortality. The all-cause mortality rate at the international level is 10% at 30 days and 34% at one year. Mortality at 30 days is secondary in 66% of cases with DPG or multi-organ failure.

The treatment of choice for the more severe PDG remains ECMO-type circulatory mechanical assistance or ventricular assistance. According to several studies, this could reduce early mortality. Early placement and short-term (\<30 days) of support appear to improve survival in the first year after transplantation.

The haemodynamic parameters revealing this DPG are not clearly described in the literature.

hypothesis of this research is that:

* DPG risk factors in strasbourg's hospital center are comparable to other European and international centers.
* Simple hemodynamic parameters can be used to detect PDG earlier in order to set up assistance more quickly.


Eligibility Criteria:
Inclusion Criteria:

* All patients who had an isolated heart transplant in the cardiac surgery department of HUS (Hôpitaux Univertsitaires de Strasbourg) between June 2008 and December 2015.

Exclusion Criteria:

* multi-organ transplants, patients with secondary graft dysfunction and those whose postoperative data were not accessible.
Serratus-intercostal Plane Block Versus Quadratus Lumborum Block in Nephrectomy: Randomized Study

Performing the nephrectomy by laparoscopy has decrease the incidence of postoperative pain, but there are still some patients who describe a severe pain after this surgery. Regional techniques allow a better recovery quality and adequate- managed pain control.

Adequate control of pain in patients with nephrectomy is a challenge for the anesthesiologist who must achieve an early recovery with minimal adverse effects. Within a multimodal strategy, the work hypothesis is based on comparing the analgesic efficacy of two regional techniques in patients undergoing nephrectomy, in terms of quality of postoperative recovery, pain control, absence of adverse effects and ease of performance.

Eligibility Criteria:
Inclusion Criteria:

* signature of informed consent
* age \> 18 years
* ASA risk scale \< IV
* Scheduled to nephrectomy.

Exclusion Criteria:

* Patients with cognitive impairment or inability to sign informed consent,
* Refused to participate
* Hypersensitivity to the drugs used
* contraindication of regional technique (coagulopathy, infection)
* history of chronic pain.
Rigid Thoracoscopy Versus CT-Guided Pleural Needle Biopsy

The aim of this study is to compare the rigid thoracoscopy with CT-guided pleural needle biopsy by the diagnostic efficacy and safety in patients with pleural effusion.

Pleural needle biopsy with Abrams needle, which can be performed by all chest physicians, is a simple, safe and cheap method of obtaining tissue from pleura, but its diagnostic rate is between 7 % -72 %, \~ 50 %. Problems for Abrams needle are scattered tumoral involvement on pleura, blind performance, small tissue sampling, to tend to early and dense fibrosis and usually involvement of lower pleural surface and diaphragmatic pleura.

Pleural needle biopsy with Abrams' needle, which can be performed by all chest physicians, if done with image guided and if this increase the diagnosis rate, the number of second procedure which is more expensive and hard will decrease.

The study aims the comparison of rigid thoracoscopy with CT-guided pleural needle biopsy by the diagnostic efficacy and safety in patients with pleural effusion.

It has been planned that a total of 120 patients accepted to the study who have pleural effusion at plain chest roentgenogram. All patients are being randomized after underwent contrast-enhanced CT. Undiagnosed patients of biopsy group are performed thoracoscopy and undiagnosed patients of thoracoscopy group followed up.

Two groups will compare by age, sex, Karnofsky performance status (KPS), diagnosis and complication rate.

Eligibility Criteria:
Inclusion Criteria:

1. Ages between 18-85
2. Pleural effusion in conventional radiography
3. At least 10x10 cm space in pleural space with effusion
4. No bleeding diathesis
5. Informed consent

Exclusion Criteria:

1. Patients who went under pleural biopsy before
2. Arrythmia
3. Hypertensive attack during biopsy
4. Bleeding diathesis
5. Hypoxemia
Non-microradical Resection Margin as a Predictor for Recurrence After Complete Mesocolic Excision

The study aim to investigate the value of the current definition of microradical resection margin in colon cancer. Is the distance from tumor tissue to resection margin and the site of any clinically prognostic importance if complete mesocolic excision has been performed.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing elective curative intended complete mesocolic excision for primary colon adenocarcinoma at Nordsjællands Hospital in Hillerød, Denmark
* International Union Against Cancer (Union Internationale Contre le Cancer - UICC) stage III - pT1-4, pN1-2 cM0 (gastroepiploic and infrapyloric lymph node metastases are not considered as distant metastases)
* Resident in Denmark at the time of surgery.

Exclusion Criteria:

* Patients who did not undergo macroradical resections
* Synchronous colorectal cancer
* Venous invasion at central venous ligation.
Phase 1/2 Clinical Study of Lutetium Lu 177 JH020002 Injection in Patients with Advanced Prostate Cancer

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, radiation dosimetry, and preliminary efficacy of Lutetium Lu 177 JH020002 Injection in adult patients with advanced prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Subjects are required to get informed consent prior to the trial and sign a written informed consent form voluntarily.
* Male, age ≥18 years.
* ECOG score 0 - 2.
* Must have a life expectancy \>6 months.
* Histologically and/or cytologically confirmed adenocarcinoma of the prostate (except for those with neuroendocrine or small cell prostate cancer clinical features).
* Participants must have a castrate level of serum/plasma testosterone (\< 50 ng/dl, or \< 1.7nmol/L).

Exclusion Criteria:

* Diagnosed with other malignancies, apart from: adequately treated skin basal cell carcinoma or superficial bladder cancers from which the patient has been disease-free for more than 3 years as confirmed by a physician.
* Participants with a history of central nervous system (CNS) metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity.
* Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation \<6 months prior to date of first administration of investigational drug.
* Previous PSMA-targeted radioligand therapy.
* Previous radiotherapy for prostate cancer within 4 weeks prior to date of first administration of investigational drug.
* Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy, poly adenosine diphosphate-ribosyl polymerase inhibitors (PARPi) or biological therapy within 4 weeks prior to date of first administration of investigational drug.
* Must not take part in other investigational therapies within 4 weeks prior to date of first administration of investigational drug.
* History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.
Evaluation of a Diabetes Data Management System

The purpose of this study is to evaluate a diabetes data management program in the hands of potential users, both health care professionals and lay users.

Diabetes data management programs analyze blood glucose results downloaded from glucose meters to assist health care professionals or lay users manage their diabetes. During the study, subjects download meters, generate and print reports, evaluate the program's ease of use, and verify that they understand the program output.

Eligibility Criteria:
Inclusion Criteria:

* Health Care Professionals:

  1. Must have experience using diabetes data management software in the medical office such as downloading meters, reviewing reports (computer screen or printouts), or assisting in patients' diabetes disease management using software.
  2. May include: endocrinologists, primary care physicians, nurse educators, or other medical staff involved in downloading meters or interpreting the data output.
* Lay users must:

  1. Be at least 18 years of age.
  2. Have diabetes (or be the parent or legal guardian of a child with diabetes) and have been testing blood sugar at home at least twice daily for one month or more.
  3. Be able to speak, read and understand English.
  4. Currently using diabetes management software at home or be familiar with diabetes management software. At least 75% of subjects must have been using software for at least one month.
  5. Have experience using PC programs or browsing the internet.

Exclusion Criteria:

* Persons working for a competitive medical device company.
Advantages of Early Intrauterine Transfer of "blank" Culture Medium Prior to 1st or 2nd Transfer of Thawed Embryo(s).

Despite technical advances in Medically Assisted Reproduction (AMP), the success of fertility treatments is sometimes limited by embryo implantation failure. The coordinated development of the embryo and the uterine endometrium requires close communication between the maternal tissue and the embryo. In in vitro fertilization (IVF), embryo transfer generally takes place between the 2nd (D2) and the 6th (D6) day following oocyte fertilization. Recent studies have shown the advantages of sequential transfer (transfer of an embryo on D2/D3 followed by the transfer of another embryo on D5/D6), with higher implantation and clinical pregnancy rate, fewer miscarriages, more live births, and yet no increase in multiple pregnancies. However, the American Society for Reproductive Medicine recommendations continue to prioritize the transfer of a single embryo for all patients aged under 38. To improve pregnancy rates for patients having a single embryo transferred, the study investigators wish to carry out on "blank" transfer, based on the principle of sequential transfer. The study investigators hypothesize that a culture medium, placed in the uterus before the time of embryo transfer, will modify immune tolerance. The study will test whether transferring the same culture medium in an equivalent quantity as during the real transfer into the uterus 2/3 days before the embryo transfer will improve tolerance to this foreign medium and, therefore, embryo implantation. The aim of this study is thus to evaluate the impact of a "blank" transfer with culture medium alone, on the results of frozen embryo transfers (FET) from IVF.


Eligibility Criteria:
Inclusion Criteria:

* Having had a first "fresh" or frozen embryo transfer, whatever the embryo's stage of development, transfer followed by pregnancy failure ;
* Frozen embryos must be at least D3 stage;
* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan

Exclusion Criteria:

* The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
* The patient is under safeguard of justice or state guardianship
3D Printed Made to Measure Splints for Hand Patients

This study aims to evaluate the feasibility and possible benefits of 3D-printed made to measure splints for postoperative or post-traumatic treatment in hand surgical patients (intervention group) in comparison to thermoplastic splints individually adjusted by occupational therapists (control group).


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting to the hand surgical department of the University Hospital Basel
* Patients with hand trauma w/wo the need for hand surgery or patient with planned elective hand surgical intervention
* Indication for immobilization of at least 4 weeks
* Older than 18 years
* Capable of consent
* Informed Consent as documented by signature

Exclusion Criteria:

* Open wounds with tissue loss
* Injury with the need for external fixation
* Younger than 18 years
* Not capable of consent
* Asymmetric deformity or loss of the contra-lateral hand
* Documented hypersensitivity or allergy to Polylactic acid
* Known or suspected non-compliance to agreed treatment measures and/or unexcused nonappearance to hospital appointments
* Drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Previous enrolment into the current study
Immunohistochemistry Role in Better Prognosis of Endometrial Carcinoma Patients

The incidence of endometrial cancer (EC) is increasing .Different risk classifications are used to direct the primary and adjuvant therapy. The European Society for Medical Oncology - European Society of Gynaecological Oncology -European Society for Radiotherapy \& Oncology (ESMO-ESGO- ESTRO) could guide the need for lymph node surgery pre-operatively, and also post-operatively to determine adjuvant treatment.

Low-risk patients are managed with surgery alone, while higher-risk group patients undergo more aggressive surgical options. So, it is important to identify new prognostic markers for better stratification of patients to avoid under- or over treatment of EC patients.


Eligibility Criteria:
Inclusion Criteria:

* aged 36 -72 years;
* Previously diagnosed with endometrial carcinoma;
* Histological Type of the tumor;
* Myometrial Invasion;
* lymph Node Invasion;
* Cervical Invasion;
* Biomarkers expression.

Exclusion Criteria:

* Lack of tumor tissue in tissue block
The Effect of Chewing Duration on Blood Glucose Levels

This study aims to assess the impact of speed of consumption of two starch-based foods varying in fibre content on blood glucose levels in normal healthy subjects. Furthermore, the mediating roles of salivary amylase and particle size on blood glucose levels will be studied. The study has a randomized cross-over design. Subjects consume two test-lunches (chick peas and brown rice) in duplicate on 8 different test days, at either long or short chewing duration. Glucose responses will be monitored via a continuous glucose monitoring device and expectorated boluses will be collected during each test day for assessments of amylase activity and food particle size.

Research suggests that high glucose level variability and large dips in glucose levels may have a negative impact on cognitive function and self-reported wellbeing. The way food is consumed (e.g. chewing duration) may regulate blood glucose levels. The underlying mechanism that links consumption speed to metabolic responses, satiation and health is largely unknown.

This study aims to assess the impact of speed of consumption of two starch-based foods varying in fibre content, on blood glucose levels in normal healthy subjects. Furthermore, the mediating roles of salivary amylase and particle size on blood glucose levels are studied.

The study has a randomized cross-over design. Each subject consumes two different test-lunches (chick peas and brown rice) in duplicate at either long or short duration. Their breakfast will be standardized during these 8 test days. For a duration of 12 days, blood glucose levels will be monitored via a continuous glucose device. Furthermore expectorated boluses will be collected for assessment of amylase activity and food particle size.

Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy men and women (based on questionnaire, self-reported)
* Aged between 18 - 55 yrs
* BMI between 18.5 - 30 kg/m2
* In possession of a Smartphone running on iOS or Android

Exclusion Criteria:

* Diagnosed with Diabetes mellitus type 1 or 2
* Under treatment for neurological or psychiatric complaints, including eating disorders
* History of gastro-intestinal surgery or having (serious) gastro-intestinal complaints
* Use of medication/supplements that may influence the study results, such as medicines known to interfere with glucose homeostasis. This will be judged by our medical doctor
* Following a diet or gained/lost \>=5kg weight in the previous month.
* Coeliac disease or gluten intolerance
* Skin allergy, eczema or known sensitivity for plasters
* use of drugs
* Current smokers
* Using \> 14 glasses of alcohol per week
* Having a food allergy for the test foods
* Participation in another clinical trial at the same time
* Suffering from a stomach emptying disorder
* Employed by or an intern at the FHCR group of Wageningen Food \& Biobased Research.
Low-intensity Resistance Exercise and Diet on Arterial Function and Blood Pressure

* Obesity is a major risk factor for premature arterial abnormalities including high blood pressure and increased stiffness. Previous studies have shown that weight loss via lifestyle modifications is associated with a decrease in large artery (aorta) stiffness. However, along with decreases in fat mass, hypocaloric diet reduces muscle mass. Low-intensity resistance exercise training (LIRET) results in similar increases in muscle mass and strength than those observed after high-intensity resistance exercise.
* The investigators hypothesis is that weight loss via diet combined with LIRET would additively reduce arterial stiffness and blood pressure (BP) in obese women. The investigators also hypothesize that the improved arterial function with weight loss would be associated with beneficial changes in the main mechanisms involved in BP regulation.

The purpose of the study is to examine the effects of 12 weeks of low-intensity resistance exercise training (LIRET) and diet on arterial function, autonomic function, and body composition in obese women with high blood pressure (BP). Specific aims of the study are to:

* To evaluate the extent to which diet and LIRET will improve body composition assessed by changes in fat mass and lean mass using dual-energy x-ray absorptiometry and waist circumference.
* To investigate that combined diet and LIRET are more efficacious than either treatment alone in ameliorating cardiovascular disease risk factors by assessing arterial stiffness (aortic, systemic, and leg), aortic BP and wave reflection, and autonomic function (heart rate variability, vascular sympathetic activity \[low-frequency power of systolic BP variability\], and baroreflex sensitivity). Circulating levels of adipocytokines (adiponectin and leptin) and endothelial-derived vasodilators (NO metabolites \[NOx\] and prostacyclin) and vasoconstrictors (endothelin-1 and prostaglandin F2α) will be assessed as secondary outcome variables.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 40 to 65 years of age
* Body mass index of 27-39.9
* Sedentary or low active (less than 2 hr per wk)

Exclusion Criteria:

* Younger than 40 or older than 65 years of age
* Body mass index lower than 27, or 40 or higher
* Physically active or competitively active
* Smoker
* Systolic blood pressure higher than 140 mmHg
* Use of hormone replacement therapy of less than 1 yr
* Use of calcium channel blocker or beta blockers
* Type 1 diabetes
* Uncontrolled type 2 diabetes