cyrilzakka/clinical-trials huggingface dataset:
Prostate Metabolism, Cancer Risk and Gut Microbiota

This is a prospective, single center translational multiple cohort study to investigate the association of gut microbiota and prostate cancer.

Prostate cancer (PCa) is a significant health care system challenge. PCa is the most common male cancer in Finland and most western countries. Interestingly, although the incidence of indolent (latent) PCa is very similar throughout the globe, there is a remarkable global age-adjusted incidence variation (up to 40-fold difference between highest and lowest incidences).

Epidemiological data suggest that aging in men is associated with neoplastic processes in the prostate but only a subset of men will develop a true malignancy potentially affecting their life-span or quality of life. Genetic factors have a significant effect on PCa risk, but very likely life-style (e.g. diet and physical activity) affect PCa risk as well, but the mechanisms mediating protective or harmful effects of life-style remain unclear.

Gut microbiota, i.e. the collection of microbes colonizing the gastrointestinal tract, has been acknowledged to play significant role in many metabolic pathways and pathogenetic processes in the human body. Although there is some evidence suggesting that gut microbiota affects therapy responses (especially androgen deprivation) in PCa, it´s potential role in prostate carcinogenesis is not well documented. Our previous studies suggest that gut microbiota composition is different in men with and without PCa potentially contributing to the Pca risk, and that changes in steroid hormone synthesis may be one mechanism how gut microbiota affects PCa risk.

PROMIC is a prospective, single center translational multiple cohort study to investigate the association of gut microbiota and PCa. The main aim is to validate our preliminary findings of association between gut microbiota and PCa. We also study metabolic characteristics in the gut, systemic circulation, and prostate tissue in men with different gut microbiota signatures. The study is carried out in Turku University Hospital and University of Turku.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form.
* Ability and stated willingness to comply with all study procedures and availability for the duration of the study.

Exclusion Criteria:

* inability to comply with study procedures or unwillingness to participate in the study.
Application of 3D Printing Technology in Subtalar Arthrodesis

This study aims to use 3D printing personalized plate to locate the position in which the K-wires would be drilled to save operation time and decrease the number of times that the K-wires are drilled.

Subtalar arthrodesis is a standard procedure for treating joint injuries in terminal stage. In this study, in order to improve efficacy and shorten the operation time, personalized plate is prepared before surgery. During the surgery, the articular cartilage is scraped, then the fusion joint is reset to the functional position; the 2-2mm Kirschner wires are drilled with the assistance of the personalized plate,then the position of the fusion joint as well as the Kirschner wires are confirmed under the C-arm; lastly, cannulated screws are screwed in along the Kirschner wires for effective fixation.

In the past surgeries without personalized plate, surgeons could only rely on their experience to locate the position for drilling and then confirm under the C-arm. This would prolong the operation time and be more traumatic to the patients. Using 3D printing personalized plate can solve this problem.

The preparation procedure for the personalized plate: firstly, ankle model are established according to the patient's CT scan data, then select modular pieces to prepare the personalized plate, sterilize it for future use. Apply conventional surgical treatment to the subtalar surface, reset the fusion joint to the functional position, and drill 2-2mm Kirschner wires with the guidance of the plate. If the locations of the fusion joint and the Kirschner wires are satisfying under the C-arm inspection, drill the hollow screw for final fixation.

Eligibility Criteria:
Inclusion Criteria:

* Patients who receive subtalar arthrodesis and consider internal fixation with screws

Exclusion Criteria:

* Patients who receive subtalar arthrodesis but do not consider internal fixation with screws
Prospective, Non-interventional, Multi-center Safety Study of Mirena for Heavy Menstrual Bleeding and Dysmenorrhea

The primary objective in this study is collecting post-marketing information on the safety. Thus, it includes information under the routine clinical practice on adverse events (AEs) and adverse drug reactions (ADRs) including expulsion and abnormal bleeding that occur within the first 12 months Mirena insertion.

The secondary objective(s) in this study is/are collecting information on Mirena effectiveness, such as periodic blood loss and Quality of life (QOL), use of analgesic and dysmenorrhea pain as far as these are recorded under routine clinical practice.

This local, non-interventional, multicenter, single-cohort study using primary data includes patients treated with Mirena for Heavy menstrual bleeding(HMB) and/or dysmenorrhea (contraception is not included).

A total of 600 patients (valid for safety analysis) is planned to be enrolled in two years. No formal sample size estimation was conducted, it was determined based on feasibility.

Target population is patients with HMB and/or dysmenorrhea diagnosis. The treatment should be performed based on the product label in Japan. The standard observation period will last for 12 months from starting Mirena treatment.

Eligibility Criteria:
Inclusion Criteria:

* Female patients diagnosed with HMB or/and dysmenorrhea.
* Patients for whom newly starting treatment with Mirena was made as per investigator's routine treatment practice
* Written informed consent

Exclusion Criteria:

* Patient whose purpose is only contraception
Comparison of Etomidate Plus Propofol, Etomidate Alone on Induction of Anesthesia

Comparison of Etomidate plus Propofol vs. Propofol or Etomidate alone during induction of anesthesia.

Comparison of Etomidate plus Propofol vs. Propofol or Etomidate alone during induction of anesthesia. The specific aims are testing patient reactions during induction, and in the post-anesthesia care unit (PACU).

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective non-cardiac surgery
* ASA physical status of 2 or 3
* Age equal to or greater than 18 years old

Exclusion Criteria:

* Adults unable to provide consent
* Age less than 18 years old
* Pregnant women
* Prisoners
* Difficult airway
* Morbid Obesity
* Preoperative sedation use
* Severe Cardiac, pulmonary and liver disease
* Hypotension and shock
* Emergency surgeries
* Allergy to propofol or etomidate
SEP-SEQ Trial - Determining the Etiology of Sepsis Using an Infectious Disease Diagnostic Sequencing Assay

The purpose of this study is to evaluate the performance of the Karius Infectious Diseases Plasma Sequencing Assay in patients who present to the emergency room with sepsis.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older
2. Meet 2 of 4 sepsis criteria

   1. Temperature \> 38C or \< 36C
   2. Heart rate \> 90 bpm
   3. Respiratory rate \>20 or PaCO2 \<32mmHg
   4. WBC \>12000/µL or \< 4000/µL or \> 10% bands

Exclusion Criteria:

1. Inability to understand instructions and comply with study-related procedures
2. Any condition that in the opinion of the treating physician will prevent the subject from completing the study.
Microbial Community Transplantation on the Armpit.

The malodour generation of a person's armpit is caused by the bacteria thriving on that armpit. In order to alter or reduce once bad body odour, the living microbial community on the armpit of a non-malodorous person will be transmitted (or up scaled and transmitted) to the armpit of a malodorous person. The odour is evaluated by a trained smelling panel, the bacteria living on the armpit is examined by means of molecular techniques. The microbial transplantation and its follow-up happens under the supervision of a medical doctor.


Eligibility Criteria:
Inclusion Criteria:

* bad armpit odour
Efficacy and Safety of Alfacalcidol Compared to Calcitriol for Treatment of Secondary Hyperparathyroidism

This study was performed to determine whether calcitriol provides a therapeutic advantage to alfacalcidol for treatment of secondary hyperparathyroidism in ESRD patients.

Secondary hyperparathyroidism has a significant impact on morbidity and mortality in advanced chronic kidney disease (CKD).Both nonselective and selective vitamin D receptor activators (VDRAs) are demonstrated in many studies for their efficacy on suppression of PTH. Most of them are quite expensive and unavailable in many countries. Calcitriol and alfacalcidol are less expensive and worldwidely distributed. There is only one short-term study which directly compares these two drugs. This study demonstrates that calcitriol is superior to alfacalcidol. However, alfacalcidol is a prohormone of calcitriol. It has to be converted by 25-hydroxylase at the liver to generate 1,25-dihydroxyvitamin D3 to act on target cells. Many pharmacokinetics studies demonstrate that alfacalcidol has lower AUC compared to calcitriol if they are administered in the same dose. Therefore, the authors hypothesize that alfacalcidol may be equivalently efficacious as calcitriol if its dose is adjusted according to the pharmacokinetics studies.

Eligibility Criteria:
Inclusion Criteria:

* Chronic hemodialysis patients who underwent scheduled hemodialysis for at least 3 months with secondary hyperparathyroidism (intact PTH levels \> 300 pg/mL)

Exclusion Criteria:

* (1) age \< 18 years (2) hypersensitivity to calcitriol or alfacalcidol (3) inadequate dialysis \[defined as single-pooled Kt/V (sp-Kt/V) \<1.2 and \<2.0 for thrice a week and twice a week hemodialysis\] (4) corrected serum calcium \>10.2 mg/dL or serum phosphate \>6 mg/dL after adjusting dialysate calcium and phosphate binders (5) diameter of parathyroid gland \>10 mm (6) pregnancy or lactation (7) liver cirrhosis (8) active kidney transplantation (9) previous parathyroidectomy (10) malignancy or chronic infection/inflammation.
Optimizing the Care Pathway of Febrile Children Via Capillary C-reactive Protein Assay in Primary Care

Fever is the leading reason for outpatient consultations among children aged 2 to 9 years. The main concern in fever is severe bacterial infection, particularly for younger children. History and clinical examination do not always differentiate viral infections from bacterial infection. In 20% of febrile children, no infectious focus is found after examination and additional tests are necessary. The first one is measuring C-reactive protein (CRP). The results are obtained in several hours on an outpatient basis, causing long delays before starting treatment and often requiring telephone calls or further consultations. Emergency room use is constantly increasing, generating growing tensions within healthcare facilities, yet a large number of visits are avoidable. Among children visiting the pediatric emergency room, parents reported being referred by their primary care physician in approximately 20% of cases for children aged 1 to 5 years and in 30% of cases for children under one year old. The use of capillary medical device to measure CRP in primary care could reduce this referral rate and help relieve overcrowding in emergency rooms, as well as unscheduled consultation centers and medical analysis laboratories. This would result in a streamlined care pathway, saving time for both physicians and patients, as well as reducing the cost of care for the healthcare system.


Eligibility Criteria:
Inclusion Criteria:

* The patient must be a member or beneficiary of a health insurance plan
* Children consulting primary health institutes with fever (temperature ≥ 38°C) requiring CRP testing:

  * Fever \> 12h in infants aged 3 to 6 months
  * Fever ≥ 5 days in children over 6 months of age
  * Fever \>12h regardless of age, and at the time of consultation, the doctor is concerned about the child's general condition, the tolerance of the fever, or doubts about a bacterial focus (e.g. suspicion of pneumopathy, appendicitis, etc.).
* No severity criteria necessitating immediate hospitalization
* No bacterial infection whose diagnosis is exclusively clinical or identified by other means (e.g. purulent AOM, bacterial angina identified by RDT, etc.).
* Child whose parents and child have been informed about the study, and at least one parent has given consent for their child's participation in the study.
* Enrolment of the child according to their capacity of discernment (for children aged 12 and over, enrolment is essential).
* Child affiliated to or benefiting from a health insurance scheme

Exclusion Criteria:

* The subject is participating in a category 1 interventional study, or a study with drug or medical device
* Premature infants under one year of age
* Immunosuppression
* Insulation
* Chronic infection
* Malignant pathology
* Autoimmune pathology
* Sickle cell disease
* Child with a central catheter
Dynamic Change in Accommodation After Wearing Multifocal Soft Contact Lenses for Myopia Control

The purpose of this study is to report the changes in accommodation, aberrations, and myopia in patients wearing multifocal soft contact lens for various durations.

The study objectives are to:

1. Determine the effects of wearing multifocal soft contact lens on accommodation and aberrations over a 12-month period.
2. Determine the effect of wearing multifocal soft contact lens on myopia over a 12-month period.


Eligibility Criteria:
Inclusion Criteria:

* Age: 8-17 years
* Refractive error: Sphere ≤ -10.00D, Cylinder ≤ 1.00D
* Monocular BCVA 20/25 or better
* No previous CL experience required

Exclusion Criteria:

* History of ocular pathology, binocular vision anomalies, refractive surgery, previous myopia control therapy, pharmaceutical agent known to affect accommodation.
New Tool of Subjective and Objective Functional Evaluation and the Quality of Life After Arthroplastic Surgery of the Hip and the Knee Assisted or Not by Computer and Mini-invasive Arthroplasty

Hip or knee arthroplasties allow a relief of pain and a good functional habilitative at patients suffering from degenerative osteoarthritis of these articulations with medium and long-term good results. The main objective of this study is to compare the efficiency in short and medium-term functional impact parlance of two surgical techniques: computer-assisted surgery and mini-invasive surgery compared to the conventional techniques thanks to an innovative technology of ambulatory analysis of walking.


Eligibility Criteria:
Inclusion Criteria:

* Weight \< 100 kg
* score UCLA \> 4
* prosthesis of first intention

Exclusion Criteria:

* Pregnant
* score UCLA \< 4
* osteotomy near to prosthesis
* prosthesis requiring an osseous transplant
* prosthesis already set up
* infections, contagious diseases (HIV, tuberculosis, hepatitis, venereal diseases) or metastasis
* neuromuscular diseases able to perturb walking or staying
* congenital or acquired disease, or previous surgery able to have consequences on results and prosthesis survey according to the surgeon
Aerosol Generation in Dental Clinics

The study examines 4 different methods to reduce dental bioaerosol spread in orthodontic procedures.

We aim to examine 4 different methods to reduce dental aerosol spread during orthodontic procedures. These methods are: 1) high-volume evacuator, 2) high-volume evacuator and saliva ejector 3) Local Exhaust System 4) disinfection with povidone-iodine nasal swabs and chlorhexidine mouthwash.

Eligibility Criteria:
Inclusion Criteria:

* Orthodontic debonding being performed
* Acceptance to participate in the study and provide required saliva and nasal samples

Exclusion Criteria:

* Refusal to participate
* Refusal to provide saliva/nasal swab samples
* Allergy to Chlorhexidine gluconate
* Allergy to Povidone-Iodine
Evaluation of an Environmental Counsellor's Home Stay in Children Treated for Asthma or Allergic Rhinitis Via a Standardized Medical Questionnaire Randomized Controlled Superiority Trial in Parallel Arms, Multicentric (EvalPCE)

Assessment of asthmatic children and children with allergic rhinitis at day 0 and 6 months after a home visit by an environmental consultant via standardized medical questionnaires.

Asthma and allergic rhinitis are chronic diseases whose control is multifactorial (drug treatment, therapeutic education of the family and the child, consideration of a possible allergen...). When this control is not optimal, it leads to significant school absenteeism, pediatric emergency room visits and hospitalizations. Environmental conditions at home play a role in asthma exacerbations and poor control of allergic rhinitis in children. Mites, animal allergens, passive smoking, molds, cockroaches, household products, etc., are the main causes. The visit of a home environment advisor, who intervenes on medical prescription, makes it possible to evaluate the source of allergens and pollutants in the home and then to propose changes to the home. This position was created in France in 2009 by the Ministry of the Environment and is funded by the Agence Régional de Santé (ARS - Regional Health Agency). The few studies carried out to assess the effectiveness of a home visit by an environmental advisor on exacerbations of these diseases are contradictory: some show an improvement in the quality of life of asthmatic children after a home visit (via the average reduction in the number of days with symptoms/year) as well as a reduction in asthma-related morbidity thanks to a reduction in exposure to indoor allergens. Others have shown that it does not reduce the number of emergency room visits for asthma exacerbations. Furthermore, it would appear that targeted allergen avoidance measures do not reduce drug treatment in asthmatics who are already on optimal pharmacological treatment.

To our knowledge, there are no studies in France that use standardized medical questionnaires to assess disease control and quality of life before and after the visit of a home environmental consultant. For example, in Angers and Nantes, evaluation questionnaires are carried out with patients at 6 months and 1 year after a home visit, but the answers are not standardized and sometimes very subjective.

Eligibility Criteria:
Inclusion Criteria:

* Patient under 18 years of age
* With asthma or allergic rhinitis
* For whom a home visit by an environmental consultant is prescribed

Exclusion Criteria:

* Parental refusal to participate in the study
* Poor understanding of the French language not allowing to fill in the questionnaire
* Asthmatic child under 7 years old or child with allergic rhinitis under 6 years old (questionnaires not validated below these ages)
* Patient concerned by a current request for relocation
Kinesiophobia and Associated Factors in Patients With Traumatic Lower Extremity Amputation

There are limited studies examining kinesiophobia and factors associated with kinesophobia in patients with lower limb amputation. The aim of this study is to illustrate the level of kinesiophobia in patients with traumatic lower extremity amputation and to analyze the correlation between kinesiophobia and associated factors (pain, prosthesis satisfaction, fear of fall, quality of life). This cross-sectional study will involve 52 patients with traumatic lower extremity amputation. Kinesiophobia level will be measured with the Tampa Scale for Kinesiophobia (TSK). All patients will point the severity of sound limb pain, residual limb pain, low back pain and the overall prosthesis, socket system and prosthetic foot satisfaction on a Visual Analogue Scale (VAS). Falls Efficacy Scale-International (FES-I) will be used for evaluation of falls efficacy under different circumstances. The quality of life (QoL) will be assessed with Nottingham Health Profile (NHP).

Kinesiophobia is defined as an unreasonable, excessive, and debilitating fear of physical activity and movement resulting from a feeling of susceptibility to painful injury or re-injury. Kinesiophobia was demonstrated to be related to lower levels of physical activity in people with chronic pain. As a result, there is an increased risk of sedentary lifestyle. Inactivity increases the risk of chronic pain as well as other health problems such as cardiovascular diseases. Kinesiophobia also is related to poor treatment outcomes. The negative effects of kinesiophobia on rehabilitation processes including exercise programs and thus its importance in the clinical course were illustrated in studies on various diseases.

There are limited studies examining kinesiophobia and factors associated with kinesophobia in patients with lower limb amputation. The aim of this study is to illustrate the level of kinesiophobia in patients with traumatic lower extremity amputation and to analyze the correlation between kinesiophobia and associated factors (pain, prosthesis satisfaction, fear of fall, quality of life).

his cross-sectional study will involve 52 patients with traumatic lower extremity amputation. Kinesiophobia level will be measured with the Tampa Scale for Kinesiophobia (TSK). All patients will point the severity of sound limb pain, residual limb pain, low back pain and the overall prosthesis, socket system and prosthetic foot satisfaction on a Visual Analogue Scale (VAS). Falls Efficacy Scale-International (FES-I) will be used for evaluation of falls efficacy under different circumstances. The quality of life (QoL) will be assessed with Nottingham Health Profile (NHP).

Eligibility Criteria:
Inclusion Criteria:

1. aged 18-65 years
2. time after amputation ≥ 6 months
3. unilateral or bilateral amputation above the ankle level
4. using a prosthesis

Exclusion Criteria:

1. upper extremity amputation
2. the presence of musculoskeletal or neurological disease that could cause functional impairment other than amputation
3. the presence of neurological deficit.
RWE Study in the Treatment of Cervical Lesions of Various Etiology

The aim of the study was to assess the post-market performance and tolerability of Cerviron® ovules in the treatment and management of cervical lesions of different etiologies. The study included clinical data related to aspect of lesions performed during routine colposcopy exams, the degree of re-epithelialization of the cervical mucosa, vaginal pH, pain level, and vaginal bleeding level.

This study is an observational, post-marketing study conducted between May-July 2021.

The aim of the study was to assess the post-market performance and tolerability of Cerviron® ovules in the treatment and management of cervical lesions of different etiologies.

The secondary objective of this clinical investigation is the assessment of performance of the medical device by clinical exam and patients' degree of satisfaction related to the use of the medical device.

The study population included 345 participants aged 20-70 years with either a cervical lesion under treatment or with recent surgical removal of a cervical lesion.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a clearly diagnosed non-infectious gynecological disease and patients with traumatic or surgical lesions.
* Patients with either of the following medical history: trauma of the cervix, pain, bleeding after sexual intercourse, postpartum injuries or postoperative cervical lesions.

Exclusion Criteria:

* Patients with cervical cancer.
* Patients with vulvar cancer