cyrilzakka/clinical-trials huggingface dataset:
Comparison of Sample Biopsy Using Scalpel or Er:YAG Laser

For certain changes in the oral mucosa a histopathological examination of the affected tissue is indicated to confirm the diagnosis. The gold standard is the biopsy by scalpel. The aim of this study is to compare the alternative method of tissue sampling using the erbium doped yttrium aluminium garnet (Er:YAG) laser with the gold Standard.

Various parameters are compared, such as the pain intensity during and after the biopsy, the evaluation of the tissue removed by the histopathologist, the occurrence of bleeding during and after the removal and the time required for both therapies.

Patients who agree to participate in the study will be randomized (randomly) to either therapy.

Eligibility Criteria:
Inclusion Criteria:

* Indication for biopsy of the oral mucosa
* male and female adult patients
* Written consent of the participating persons after clarification

Exclusion Criteria:

* pregnancy
* Taking blood thinners
* Known infectious diseases
* Untreated diabetes mellitus
* Taking immunosuppressants
Association of Multiple CardiOvascular Risk Factors and Erectile Function Across Europe

The purpose of the study is to evaluate the influence of cardiovascular risk factors, heart failure and cardiovascular drug therapy on erectile function in cardiovascular high-risk patients.

Association of cardiovascular risk factors and ED is likely due to an impairment of endothelial function resulting in a decreased activity of endothelial NO-synthase, which plays a major role in physiology of erection. Heart failure is also known to further contribute to endothelial dysfunction and hence, this could lead to erectile dysfunction.

Study Objectives

1. Evaluation of the influence of cardiovascular risk factors and concomitant medication on erectile function in cardiovascular high-risk patients.
2. Evaluation of the role of heart failure on prevalence and severity of erectile dysfunction in men.
3. Long-term effects of cardiovascular drug therapy and cardiovascular diseases on erectile function.

Study Design Male patients across Europe with cardiovascular diseases (CHD, PAD and heart failure) will be evaluated with a standardized questionnaire. Grade of erectile dysfunction will be assessed using an ED-score, generated from two different questionnaires.

1. IIEF-5 - (International Index of Erectile Function)
2. KEED - (Cologne Evaluation of Erectile Dysfunction)

Primary Endpoint The primary endpoint is the sum score of the ED rating scale of the KEED (Kölner Erhebungsbogen zur Erektilen Dysfunktion, see Appendix 1). Erectile dysfunction is defined as reaching more than 17 points in the sum score.

Secondary Endpoint The first secondary endpoint is the frequency of sexual activity and sexual desire. Another secondary endpoint contains satisfaction with sex life and general well-being. Men are defined as dissatisfied by answering "mixed" or "worse".

Follow-Up: after 1 year, after 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Male patients with two or more cardiovascular risk factors or
* Male patients with a manifestation of atherosclerosis or
* Male patients with an ischemic or dilated cardiomyopathy
* Written informed consent

Exclusion Criteria:

* Impairment of hormonal status
* Refusal of written informed consent
* Inability to complete the questionnaires
Prediction of PEP Based on the Appearance of the Major Duodenal Papilla

This observational, prospective study aims at evaluating how the occurrence of post-Endoscopic Retrograde CholangioPancreatography (ERCP) acute pancreatitis (PEP) could be influenced by difficult biliary cannulation that might be previously assessed by the morphological appearance of native major papilla in all the patients undergoing ERCP.

The rate of successful biliary cannulation across papilla types could be used as intraprocedural quality and competence metrics during training. Moreover, recognizing difficult papillae could allow reserving those to experts to decrease the odds of failed cannulation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with native duodenal papilla;
* Any indication to ERCP +/- biliary sphincterotomy of duodenal major papilla;
* Patients able to provide a written informed consent

Exclusion Criteria:

* ERCP performed for disorders unrelated to biliary tract;
* Previous upper gastrointestinal tract surgery;
* Presence of a duodenal stricture (either malignant or benign);
* Presence of a malignant infiltration of the papilla;
* Concomitant anticoagulant and/or P2Y12 inhibitors therapy (clopidogrel, prasugrel, ticagrelor) that precludes the treatment;
* INR \> 1.5;
* Platelets count \< 80000/mm3;
* Unwillingness to sign written informed consent.
Mindfulness Yoga and Sexual Functioning

Female breast cancer survivors with sexual dysfunction were randomly divided into a mindfulness yoga intervention group and a control group, and the investigators aimed to evaluate the effects of mindfulness yoga on sexual function in breast cancer survivors.


Eligibility Criteria:
Inclusion Criteria:

age 18-65 years; diagnosed with primary breast cancer (stages:T1-T4, N0-N1, M0); individuals who have completed surgery, chemotherapy and radiotherapy (with the exception of immunotherapy and endocrine therapy); without cognitive impairment; diagnosed with sexual dysfunction.

Exclusion Criteria:

without sexual experience; in pregnancy or lactation; individuals with serious cognitive or psychiatric issues (i.e., depression, alcohol dependency, or psychotic disorders); individuals who are illiterate, with hearing disorder or communication difficulties; individuals with other type of tumors or other serious acute or chronic diseases at the time of enrollment; individuals participate in a concurrent medical treatment or nonmedical treatment targeting sexual problems; individuals participate in a concurrent psychotherapy; individuals with experience in mindfulness or yoga.
Azacitidine Compared to Conventional Chemotherapy as Consolidation of Elderly Patients With AML

The purpose of this study is to determine whether Azacitidine consolidation is superior to standard DA consolidation treatment of acute myeloid leukemia in first complete remission in elderly patients.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects \>65 years of age at the time of signing the informed consent form
2. A confirmed diagnosis of AML according to the 2008 WHO classification

   * This includes: Bone marrow aspirate with a good clot or biopsy for morphology, flow cytometry, cytogenetic analysis, and in case of normal cytogenetics, molecular genetic analyses including FLT3-ITD, NPM-1 and CEBP A
   * Bio-banking of leukemic cells at diagnosis performed (according to guidelines of the Swedish National AML biobank).
3. A documented CR or CRp achieved after one or two induction courses.

Exclusion Criteria:

1. Subjects who are not considered to be candidates to complete the consolidation therapy due to medical or psychological reasons.
2. Subjects who have taken any investigational drugs or participated in an interventional clinical trial within 30 days prior to screening.
3. Patients with acute promyelocytic leukemia
4. Patients with t(8;21) or inv(16)
5. CNS leukemia
6. Patients with a previous diagnosis of MDS, i.e. AML preceded by a diagnosed MDS
7. Subjects who are candidates for allogeneic stem cell transplantation (SCT)
8. Another cancer diagnosis with a life expectancy of less than two years
Neoadjuvant Radiotherapy for Malignant Lacrimal Sac Tumors

The treatment for malignant lacrimal sac tumors is difficult and the prognosis is poor. The conventional strategy is surgical resection followed by adjuvant radiotherapy with or without concurrent chemotherapy. This approach has many drawbacks including positive surgical margins due to large tumor size, distant metastasis due to intraoperative squeeze, and implant exposure due to high doses of radiation. In previous research, the investigators innovatively adopted neoadjuvant radiotherapy (or chemoradiotherapy) and withdrew radiotherapy after surgery. Preoperative radiotherapy can effectively reduce the tumor size and encapsulate the tumor in a fibrotic cyst, and therefore enables en-bloc excision of the tumor and simultaneous orbital reconstruction. This multidisciplinary approach can reduce the risk of recurrence and metastasis, lower the dose of radiation, and avoid implant exposure after reconstruction.

In order to compare the long-term outcomes between neoadjuvant radiotherapy and conventional treatment approach, the investigators will prospectively recruit 94 patients with malignant lacrimal sac tumors and randomly assign these subjects into the study group (neoadjuvant radiotherapy, 47 cases) and the control group (conventional treatment, 47 cases). The primary outcomes include overall survival, disease-free survival, distant metastasis-free survival, and locoregional control at 2-year, 5-year and 10-year intervals. The secondary outcomes include ocular functions (visual acuity and diplopia, tear film stability and tear secretion, globe dystopia and motility, and corneal topography), acute and chronic radiation-related toxicity, cosmesis (medial canthal tendon dystopia and eyelid retraction), and assessment of quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patients with suggestive symptoms, signs, imaging features and/or biopsy results for malignant lacrimal sac tumors
* Regardless of previous operations including silicone tube intubation, endoscopic dacryocystorhinostomy and incisional/needle biopsy

Exclusion Criteria:

* Recurrent tumors
* Metastatic tumors to the lacrimal sac region
* Malignant lacrimal sac tumors with previous surgical excision
* Malignant lacrimal sac tumors with local nodal or distant metastasis
* Special tumor types (e.g. lymphoma) which require non-surgical treatment
* Large tumors (invades ≥ 2/3 depth of the orbit) which require orbital exenteration
Efficacy of Different Versions of the Best Possible Self Intervention

The aim of this study is to analyze the efficacy of several variations of an already validated Positive Psychology Intervention (PPI) called Best Possible Self, using Information and Communication Technologies (ICT) in general population. Participants are randomly assigned to one of 4 conditions: BPS PAST condition, BPS PRESENT condition, BPS FUTURE condition, and CONTROL condition (daily activities).

Intervention lasts 7 days. Participants come to the laboratory the first day, they fill up assessment questionnaires and practice the assigned exercise. Then, they practice the assigned exercise for 6 more days at home.

The main hypothesis is that all three experimental conditions will enhance wellbeing comparing to the control condition.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be 18 years old or older.
* Participants must be willing to participate in the study.
* Participants must have computer with Internet access and e-mail address.

Exclusion Criteria:

* To suffer from moderated or severe depression as established by a score of 20 or more in the Beck Inventory of Depression (BDI-II; Beck, 1996).
Exemestane (Aromasine) + Tamoxifen - Breast Neo-Adjuvant

This is a Phase II non-randomized, open, uncontrolled and bi-centric study of hormonal induction by exemestane (Aromasin) + tamoxifen to evaluate the effectiveness of exemestane (Aromasin) with tamoxifen on the rate of clinical response menopausal in patients with tumors of locally advanced breast. Hormone therapy will be administered at a dose of 25mg/day for exemestane and 20 mg / day for 4 months for tamoxifen.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer histologically proven by a 14 G or 16 G micro-biopsy to have confirmation of the diagnosis, evaluation histology prognosis grade, hormone receptors and to obtain a sample for the study of biological factors.
* Menopausal patients as defined as follows:

  * Natural menopause \>= 1 year, or
  * Surgical ovariectomy.
* T unilateral tumor\> 3 cm, N 1-2, M0 or M +, non-inflammatory.
* Hormone receptor positive. RE positive or PR positive with histochemical technique (+ 10% of cells express the receptor)
* No previous treatment of the disease by chemotherapy, hormone therapy, surgery or radiotherapy. Discontinuation of replacement therapy of menopause for at least 1 month
* Age\>= 60 years
* Evaluable disease
* Performance Status \<= 2
* Biological function using the following criteria:

  * neutrophils \>= 2.10E9 / l,
  * Platelets\> = 100.10E9 / l,
  * Hemoglobin\> = 10 g / dl,
  * Creatinine \<= 1.5 x upper normal,
  * Total bilirubin \<= 1.25 x the upper normal
  * Transaminases (AST and ALT) \<= 1.5 x upper normal,
  * Alkaline phosphatase \<= 2.5 x upper normal.
* Cardiac Function: electrocardiogram (ECG) normal.
* Signed written consent before any procedure related to the study.

Exclusion Criteria:

* Men
* Non Menopausal Patients
* Patients with hormone receptor negative: PR- and RE -
* Contra-indication to anti-estrogens (risk thrombi arteria)
* Tumor \<3 cm operable
* Tumor inflammatory T4d (PEV 2 or 3).
* Extensive hepatic lesions (\> 1 / 3 of liver volume)
* Uncontrolled cardiac disease such as angina, congestive heart failure, or arrhythmia requiring medical treatment or history of myocardial infarction within 3 months before.
* History of cancer except skin cancer and basal cell cancer in situ of the cervix (a contralateral breast cancer had been no systemic treatment will be admitted).
* Chronic diseases (somatic or psychiatric) in poor prognosis.
* Patients who for reasons of family, social, geographical or psychological can not be followed properly.
* Patients under law protection
Posture Exercises in Parkinson's Disease

The research was planned as a quasi-experimental study to investigate the effects of postural exercises on body image and neck and trunk position sense in Parkinson's patients.

It was decided to conduct the study with Parkinson's patients over the age of 50 who applied to the neurology clinic. After the power analysis for the research, it was planned to reach 36 participants. Participants' consent to participate in the study will be obtained through the Informed Volunteer Consent Form prepared by the researchers. Demographic information of participants who consent to participate in the study will be collected. Then, the disease levels and severity of the participants will be determined using the Modified Hoehn Yahr Staging Scale and the Unified Parkinson's Disease Assessment Scale. Subjective Visual Vertical Perception, Subjective Postural Perception and Subjective Haptic Perception evaluations to evaluate the body image of patients; Clinometer application and neck and trunk proprioception evaluations will be applied as preliminary tests to evaluate neck and trunk position sense. Posture exercises planned by the researchers will be applied to the participants, whose pre-tests are completed, three days a week for eight weeks. Preliminary tests performed after eight weeks of exercise will be repeated. All data obtained will be recorded in the Participant Data Record form. Differences in changes in tests performed at eight-week intervals will be investigated with appropriate statistical methods.


Eligibility Criteria:
Inclusion Criteria:

* Being over 50 years old,
* Being diagnosed with Parkinson's disease by a physician,
* Stage 1-4 according to the modified Hoehn-Yahr staging scale
* Having received 24≥ from the Mini Mental test

Exclusion Criteria:

* Presence of another accompanying neurological disease,
* Having significant musculoskeletal system problems,
* Having any known cognitive problem or having a score of ≤23 on the Mini Mental Test
A Comparison of Propofol Based Total Intravenous Anesthesia and Desflurane Based Balanced Anesthesia on Hepatic Protection During Living-donor Liver Transplantation

Renal ischemia/reperfusion (I/R)-induced injury is known to be associated with immediate and long-term hepatic dysfunction after liver transplantation. Protecting the liver against I/R injury and maintaining hepatic function during transplant surgery is therefore very important in order to improve post-operative outcome. This purpose of this study is to investigate whether propofol anesthesia done in both liver donors and recipients during living-donor liver transplantation is effective in reducing liver I/R injury via its antioxidant and antiinflammatory properties and improve post-transplant outcome compared to desflurane anesthesia.


Eligibility Criteria:
Inclusion Criteria:

(1) Adult liver donors and recipients scheduled for liver transplantation

Exclusion Criteria:

1. Patient refusal
2. Hypersensitivity to propofol, soybeans or peanuts
3. History of vitamin C or E intake within 5 days before surgery
4. History of acute myocardial infarct within 6 months before surgery
5. Congestive heart failure (NYHA III-IV)
6. Autoimmune disease patients
7. BMI over 30 kg/m2
8. Left ventricular ejection fraction less than 35% upon preoperative echocardiography
Evaluation by Oncologists of Strategies for the Prevention and Treatment of Chemotherapy-induced Peripheral Neuropathies

Chemotherapy induced peripheral neuropathy (CIPN) is one of the most deleterious adverse effect of neurotoxic anticancer drugs affecting up to 40% of patients. These neurotoxic anticancer agents include mainly: cisplatin (bronchopulmonary cancers), oxaliplatin (colorectal cancers), paclitaxel (breast cancers and bronchopulmonary cancers), docetaxel (breast cancers and bronchopulmonary cancers) and bortezomib (multiple myeloma).

CIPN affects not only the quality of life of patients, it also has a major impact on oncology strategy, forcing oncologists to reduce dose-intensity, to stop an ongoing chemotherapy regimen and to change therapeutic strategies, with a risk of compromising patients' survival.

There is no real preventive or curative treatment (except duloxetine) for CIPN and it is not known what is the practice of oncologists in France? However, it is essential to know the degree of sensitivity of oncologists to this problem and their practice.

With this study, the investigators propose to assess the current practices of management by oncologists in France in 2019, for any type of practitioners of university hospital, or general hospital, for all type of neurotoxic anticancer drugs.

This observational and cross-sectional study will be conducted as a survey using the REDCap software and the response to this survey will be done online, in real time, with an automatic, secure and centralized data collection (CHU Clermont-Ferrand).

French oncologist will be contacted by email thanks to the regional cancer networks. Answer to the survey will be done online.

Eligibility Criteria:
Inclusion Criteria:

* Oncologist

Exclusion Criteria:

* pain physician
Evaluation of the ACE Dental Implant

Dental implants are small metal posts that look like miniature screws. They are surgically implanted into the jawbone where they serve as substitute tooth roots. Implants are used in dentistry to reestablish function and aesthetics to areas of the mouth were natural teeth are missing.

Classical dental implants are made in two pieces. One part anchors in the jawbone and one part serves as a connecting post (an abutment) that attaches to a crown restoration or to attachment clasps that hold a denture in place.

Occasionally the materials used to fasten the two implant components together work their way loose and over time the abutment may begin to disconnect. If this happens a small gap appears between the implant and abutment. There are many reasons why this loosening occurs. One reason may be the design of the implant itself and another may be the way the two components are fastened together.

This study will assess the performance of an implant with a new design. The investigators hypothesize that using this implant design will reduce the risk of an implant-abutment disconnect and improve long-term success of implant therapy.

While the external hex dental implant design has had very good clinical success, it is limited by retention screw loosening at the junction of the implant fixture and abutment; a situation that leads to micro-movement between components.

A number of clinical complications may arise when implant components separate. Micro-movement between the implant abutment and seating platform is thought to contribute to the formation of a "biological gap", the most notable consequence being gradual resorption of crestal alveolar bone over time.

We hypothesize that the "ACE CONNECT" two-piece implant design with an internal connection will limit screw loosening by providing a stable junction between the body of the implant and the abutment; a more stable junction will limit micro-movement and prevent the formation of a gap between components. Limiting the gap will lead to less inflammation of peri-implant soft tissues and reduced resorption of bone adjacent to the implant.

Eligibility Criteria:
Inclusion Criteria:

* Need for replacement of non-adjacent missing teeth with dental implants
* Edentulous in the area for more than 2 months
* Minimum native bone height and width to receive a 10mm X 4mm implant

Exclusion Criteria:

* Untreated decay or periodontal disease in residual dentition
* Need for bone or soft-tissue augmentation in the proposed implant site
* Pregnancy
* Consistent use of medications likely to compromise bone healing
* Chronic disease condition likely to compromise bone healing
* Consistent smoking over 10 cigarettes during the immediate past 6 months
COVID-19 and the Developement of Phobic Fears of Disease

A lot of people suffer from phobias. Phobias concerning certain diseases are not rare. This study will examine whether the COVID-19 (Coronavirus Disease) crisis was able to rise phobias in people and if those with preexisting phobias or fears were more likely to develop a phobia concerning COVID. It will look at different subtypes - physicians, medical staff, general public (not medically affiliated) and patients with psychiatric disorders.


Eligibility Criteria:
Inclusion Criteria:

* Person gives written consent
* Persons between 18-90 years of age (men and women)
* No positive COVID infection known at time of first examination

Exclusion Criteria:

* Dementia, Delirium (not able to give consent)
* Not fulfilling the inclusion criteria
* COVID infection known at first examination point
cGMP: Metabolism and Appetite Modulation

Phenylketonuria is an inborn error of phenylalanine metabolism. Although the phenylalanine-restricted diet is recognized as the mainstay of therapy, little is known about the impact of protein substitutes on the metabolism of patients with phenylketonuria.

Therefore, the aim of this project is to study the impact of acute ingestion of casein glycomacropeptide supplemented with amino acids (cCGMP-AAs) alone or in combination with two different meals on amino acid absorption kinetics, glycaemic and insulinemic response, and on acute markers of appetite control.

The main findings of this project will bring new insights into the dietary management of these patients, which may lead to improvements in protein substitutes formulations.


Eligibility Criteria:
Inclusion Criteria:

* Men or women
* Adults (age ≥ 18 years)
* Body Mass Index (BMI) between 18.5-25.0 kg/m2
* Filling informed consent

Exclusion Criteria:

* Clinically significant illness
* Have changed frequency, duration, or intensity of physical activity in the last month
* Taking protein supplements
* Pregnant or breastfeeding
* Smoking and drug use