cyrilzakka/clinical-trials huggingface dataset:
Hysteroscopic Guided Endometrial Sampling: Prospective Comparison Between 5Fr and 7Fr Biopsy Forceps (HYSTEROBIO)

Indication for hysteroscopic guided biopsy compared to blind biopsy have been little evaluated. However, this kind of biopsy is usually performed in many centre. They allow exploration of uterine cavity but also to perform guided biopsies on the most suspicious area. However, with 5Fr forceps, biopsy are often too small to conclude.

Blind biopsies using Novak or Cormier cannula had limits. Demirkiran et al conclude on 673 women that histology was similar between biopsies and hysterectomy in only 67% of cases. Others studies conclude thatit is difficult to conclude about focal disease with blind biopsies.

A study compared blind biopsies to biopsy performed under hysteroscopic guidance in women using Tamoxifene and conclude that guided biopsies were more specific (80% versus 68.9%) and a better positive predictive value (68.9% versus 43.7%) for all kind of endometrial pathologies

Eligibility Criteria:
Inclusion Criteria:

* • Woman over 18 year-old with abnormal uterine bleeding (or endometrium thickness over 10mm) and risk factors of endometrial carcinoma, or endometrium thickness over 5mm in a menopausal woman or abnormal uterine bleeding after 45 years old.

  * Woman who speak and understand french
  * Woman who give her written informed consent
  * Woman covered by french medical insurance

Exclusion Criteria:

* • Pregnant or breastfeeding patient

  * Patient under guardianship, curators or safeguard of justice.
  * Patient participating in another ongoing study.
An Open-Label Feasibility/Pilot Study With [123I]-IBZM SPECT (DOPA-SYN)

This study conducted to more fully evaluate the way that carbidopa/levodopa and entacapone may work in the brain. This research study uses \[123I\]-IBZM and dynamic SPECT imaging to determine the amount and the duration of dopamine release from specific regions in the brain after treatment with either the combination of carbidopa/levodopa or the combination of carbidopa/levodopa/entacapone.

This is a pilot evaluation of dopaminergic function in PD using a bolus plus constant infusion protocol with \[123I\]-IBZM and SPECT to evaluate the potential for carbidopa/l-dopa alone or carbidopa/l-dopa/entacapone to produce displacement of striatal radioactivity for assessment of intrasynaptic dopamine. We will assess the feasibility of this paradigm for detecting l-dopa effects on the SPECT signal in subjects with PD with disease duration of greater than 4yrs and with a stable response to L-dopa. Each subject will undergo three \[123I\]-IBZM studies separated by 1-2 weeks. Subjects will be off medication for at least 12 h prior to study For each of the three scan days patients will receive a constant intravenous infusion of \[123I\]-IBZM over 4-5 hours to establish an equilibrium binding condition of the radiotracer at striatal D2/D3 receptors. Three baseline SPECT acquisitions will be obtained prior to medication dosing to establish a stable baseline. At approximately 5 h after the initiation of the infusion subjects will receive a single oral dose of either carbidopa/levodopa (37.5mg/150mg or 50mg/250mg), or carbidopa/levodopa/entacapone (either 37.5mg/150mg/200mg- STALEVO or 50/250mg/200mg).

Eligibility Criteria:
Main inclusion criteria:

* The patient is aged 30 years or older.
* Written informed consent is obtained.
* Patients have a diagnosis of idiopathic Parkinson's disease.
* Hoehn and Yahr stages for patients are I-III.
* Patients have a diagnosis\> 4 yrs prior to screening
* Patients are treated with carbidopa/levodopa with \> 300 mg levodopa.

Main exclusion criteria:

* The patient has atypical or drug-induced Parkinson's disease.
* The patient has dementia (MMSE 24).
* The patient has a clinically significant clinical laboratory values, and/or medical or psychiatric illness.
* The patient has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery).
* The patient has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
* The patient has been treated with a dopamine agonist within the past 30 days.
* Concomitant treatment with Monoamine Oxidase (MAO)-inhibitors (except selegiline \<10 mg/day) within 30 days prior to the screening visit
* Patient has a history of iodine allergy
Multimodal Exercise Program on Parkinson's Disease Patients With Depression

Depression symptoms are common in Parkinson's Disease, it affects health-related quality of life. The evidence showed that exercise improved depression and HRQOL in PD patients. However, studies rarely considered the appropriate exercise program for PD patients, we want to find the best exercise program for PD patients.

Objective: Evaluate the effectiveness of a 8-week multimodal exercise program on depression and HRQOL in PD Patients.

Methods: Single-blinded, randomized controlled trial, from March 2016 to January 2017. Ninety-eight patients recruited to 2 groups: exercise group (n = 49) and control group (n = 49). The primary outcomes were depression and HRQOL; the secondary outcomes were activity of daily living, motor ability, fatigue, sleep quality and anxiety. Data collection at baseline, week 4 and 8 after intervention. Intervention were Multimodal Exercise Program, at least three times (30 - 50 minutes per section) a week or 10-15 minutes per section every day to accumulate 150 minutes a week for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* be diagnosed PD in Hoehn and Yahr stage I-II22
* under stable medication treatment at least 3 months
* no disease limiting the patient's ability to perform the exercises

Exclusion Criteria:

* severe cardiovascular disorders
* neuromusculoskeletal disorder
* cognitive impairment
* recent participation in any physiotherapy or rehabilitation program
* have exercise regularly
Clinical Study of Impact of Different Pacing Site in Patients

At present, cardiac pacing has been widely used in the treatment of bradyarrhythmias and heart failure, which can effectively improve the survival rate of patients. With the rapid development of technology, different sites can be chosen to pace, such as right atrial appendage, the atrial septum and the right atrial wall in the atrium, His bundle, left bundle branch area, right ventricular apex, outflow tract, and left ventricular pacing via coronary vein in the ventricle. There are few studies comparing the long-term efficacy and safety of different pacing sites in daily practice. This study aims to observe the efficacy and safety of cardiac pacing at different sites in short and long term, and to compare the advantages and disadvantages of pacing at different sites.


Eligibility Criteria:
Inclusion Criteria:

* Patients who received pacemaker implantation in the Second Hospital of Zhejiang Medical University by Pan Xiaohong and other surgeons.
* Patients who have the ability to understand the test and can cooperate with investigators.

Exclusion Criteria:

* Patients who unable to understand or unwilling to fill in informed consent forms or follow visitors.
Timing of Caloric Intake, Diet-induced Thermogenesis and Hormonal Pattern

The investigators aim at analyzing whether eating a standard meal in the evening (at 8:00 pm) determines in the same individuals a lower diet-induced thermogenesis (DIT) and a different hormonal response than the consumption of the same meal in the morning (at 8:00 am).

The primary outcome is: the intra-individual variation in DIT after the evening and morning meal consumption.

The secondary outcomes are the intra-individual variations in glucose, triglyceride, insulin, free fatty acids, leptin, glucagon-like peptide-1, acylated ghrelin, adrenalin, noradrenalin, after the evening and morning meal consumption.

Twenty healthy volunteers (ten males and ten females) are recruited among students and graduates attending the Department of Medical Sciences of Turin (Italy) to take part to this randomized cross-over trial.

Participants randomly receive first the standard meal at 8:00 am and the week after the standard meal at 8:00 pm or vice versa. Eight-h before the meal (respectively at 12:00 pm or at 12:00 am), the participants receive the same standard meal (without protein supplementation) at their home, and then are asked to spend in bed the following 6 hours. A 24-h urine collection is collected the day before each test in order to determine total urinary nitrogen excretion.

The standard meal consists of: 100g white bread, 100g ham, 50g cheese, 125g yogurt, 200ml fruit juice, plus 25g protein supplement. The participants must consume each meal in 25-30 minutes.

A 30-min basal calorimetric (Deltatrac II) exam is performed. Participants remain in a supine position but awake and motionless on a hospital bed during the whole period, except during the meal, when they can sit to eat. At 8:00 am (or pm), the participants consume the meal, and then rest in a supine position for 90 min. Then, a second 60 min-calorimetric evaluation is done. From the first calorimetric exam (the basal) until the end of the second (post-prandial) blood samples are drawn every 30 min. The same time schedule is adopted in the case of the morning meal (at 8:00 am) and the evening meal (at 8:00 pm).

The random sequence (morning/evening, evening/morning meal) is computer-generated, using blocks of different lengths in random order.

The following are measured: weight, height, waist circumference, and at baseline and every 30-min during the morning and evening tests: glucose, triglyceride, insulin, free-fatty acids, leptin, glucagon-like peptide-1, acylated ghrelin, adrenalin, noradrenalin.

Eligibility Criteria:
Inclusion Criteria:

* body mass index 19-26 kg/m2
* habitual moderate exercise level

Exclusion Criteria:

* any acute or chronic diseases
* menopause
* any drugs or supplementations
* any alimentary restrictions or specific diets
* being a shift or night workers
* unable to give a written informed consent
Fostering Shared Decision-making About Prostate Cancer Screening Among Clinicians and African American Men

This behavioral clinical trial assesses the efficacy of a educational intervention to increase shared decision making about prostate-specific antigen (PSA)-based screening for prostate cancer among African American males. Half of participants will receive a multimedia educational intervention, while the other half will receive usual care.

The 2018 U.S. Preventive Services Task Force (USPSTF) final recommendation states that male patients and their providers engage in a shared-decision making process about the benefits and harms of PSA-based screening. As characterized by the USPSTF, these conversations are particularly important for African American men given increased ambiguity due to the lack of PSA-based research specific to this population and increased risk of prostate cancer mortality attributed to late stage at diagnosis and more aggressive prostate cancer phenotypes seen in African American men.

The goal of this randomized behavioral clinical trial is to advance the translation path of implementing the decision-making process in clinical encounters by evaluating the efficacy of an educational intervention for African American males to increase shared decision making about PSA-screening versus usual care. The intervention will use multimedia educational training materials to increase understanding of prostate cancer, PSA-based screening, and shared decision making among patients and their primary care providers (PCPs).

Eligibility Criteria:
Patient Inclusion Criteria:

* Receiving care at the clinical sites
* Identify as African American male
* Ages 40-69 years old

Patient Exclusion Criteria:

* Personal history of prostate cancer at the time of consent
* Cognitive impairment that would interfere with participation in the study
* Unable to complete any aspect of the intervention within the specified time limit
Semirigid Cervical Collar and Nasotracheal Intubation by Glidescope in Cervical Spine Surgery

Effect of semirigid cervical collar during nasotracheal intubation by Glidescope in the elective cervical spinal surgical patients: a study of clinical predictors and outcomes

Clinically used cervical orthoses can effectively limit cervical spine motion in all direction and provide protection. Among them, the restriction by Miami semirigid collar was superior, with the least tissue-interface pressure of neck. It is one of the most used semirigid collars for patients' protection in the operating theatre. However, the presence of the semirigid collar was shown to result in a poorer view at laryngoscopy, possibly due to a reduction in mouth opening. Nasotracheal intubation is sometimes applied in cervical spinal surgeries for those receiving anterior approach for a higher cervical spine (C3) level, and/ or combined with a short neck, or due to surgeon's preference. Glidescope minimizes cervical movements during laryngoscopy, facilitates nasotracheal intubation than direct laryngoscopy and requires less technical skill than fiberoptic tracheal intubation. The investigation was to assess the effect of cervical collar on nasotracheal intubation and potential hazard factors of prolonged time for nasotracheal intubation with Gildescope in patients scheduled for elective cervical spinal surgery.

Eligibility Criteria:
Inclusion Criteria:

* elective cervical spine surgery
* scheduled for nasotracheal intubation
* not requiring orthosis for prophylactic protection

Exclusion Criteria:

* Risk of pulmonary aspiration of gastric contents
* Pathology of the nasal cavity
* Abnormal coagulation function
* Extensive and severe cord compression
* Refused to sign informed consent.
Changing the Future of Intestinal Failure in Intestinal Chronic Inflammation (INT-FAIL)

This is an interventional, prospective, no profit study that will be performed at CEMAD, from FONDAZIONE POLICLINICO GEMELLI IRCCS, Rome (UO1) and U.O.C. Internal Medicine and Gastroenterology from Ospedale Brotzu di Cagliari (UO4). Adult patients with Crohn Disease (CD) and chronic intestinal insufficiency (CF) and adult patients with CD at high and low risk of CF.

The study involves an initial evaluation in which faecal samples will be collected, a blood sample will be taken and an ileocolonoscopy with biopsy (additional biopsy collection at the same time as clinical practice biopsy for study-specific analysis) will be performed.

Patients will then be re-evaluated nine months after the initial evaluation. In particular, faecal, blood and additional biopsy samples will be collected at the same time as the clinical practice biopsy and any changes in treatment will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years-old and ≤ 75 years old
* Capable of expressing informed consent;
* An established diagnosis of Crohn's disease;
* Antibiotics treatment free for at least 15 days.

Exclusion Criteria:

* Age \< 18 years-old and \> 75 years old;
* Not capable of expressing informed consent;
* Pregnant or breastfeeding patients;
* Comorbidities including: cancer pathology present or under active treatment; coagulopathies; chronic hepatopathy, heart failure, renal failure, respiratory failure.
Clinical Relevance of the Antimicrobial Resistance Testing in the Treatment of Chronic Wounds With Antiseptics

The study objective is to improve the current and local standard antiseptic treatment by adjusting the antiseptic agent to the antimicrobial resistance testing result, accordingly. Currently, resistance testing will only be performed for the treatment with antibiotics.

Complications like bacterial wound colonization and infections in wound treatment are still a serious problem. Several therapy approaches are available to treat these complications, e.g. surgical wound debridement, antimicrobial therapy that can be divided into a local and a systemic antisepsis.

The local antisepsis (the local utilization of antiseptics directly to the wound) is in many ways advantageous to the systemic antisepsis (orally or intravenously administered antibiotics): e. g. the direct contact of the antiseptic to the bacteria at the site of infection whereas antibiotics may not sufficiently reach the wound due to limited blood perfusion of wounds; growing utilization of systemic antisepsis also leads to an increasing number of resistant bacteria worldwide. To the concerns of many specialists, the first pan-resistant bacterial strain which is resistant to all available antibiotics including colistin was recently published.

In future, the role of local antisepsis therefore becomes more important in the antimicrobial treatment. Luckily, resistances of local antiseptics occur slowly due to the chemical and structural characteristics of antiseptics but even resistances of bacteria to antiseptics were reported. Unlike the antimicrobial resistance testing for antibiotics that is done in the clinical routine, such testing is not a standard procedure for antiseptics for no obvious reason. The utilization of antiseptics is determined by the availability of products provided within the institution and preferences of the clinician. Thus, it is unknown whether the chosen antiseptic has any bactericidal effect on the confirmed bacteria.

University Hospital RWTH Aachen Wound Care only uses polyhexanide and octenisept. Iodine-containing preparations are explicitly not desired.Improvement (bacteria reduction, acceleration of wound healing) of the local antiseptic therapy by adapting the antiseptic to the results of antimicrobial resistance testing. Antimicrobial resistance testing has so far only been used to adapt systemic antibiotic therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Decubitus OR secondary healing acute and chronic wounds
3. Positively tested wound swab for bacteria (incl. multi-resistant bacteria)
4. Patient is capable of understanding the nature, significance and consequence of the clinical trial
5. Given written consent
6. Women of child bearing potential (WOCBP) who apply appropriate methods of contraception throughout the duration of the study

Exclusion Criteria:

1. Occlusive dressing (e.g. VAC) or Negative Pressure Wound Therapy (NPWT)
2. Pregnant or lactating women
3. Known allergies against investigational products
Adipose-derived SVF for Treatment of Alopecia

The general objective of this study is to conduct a safety and feasibility study of a single injection of autologous adipose-derived SVF for the treatment of alopecia.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females 18 - 60 years of age and older that have been diagnosed with androgenetic alopecia.
2. Subjects will be in good health (ASA Class I-II) with a BMI \< 35. Must have at least a 2cm x 2cm spot on the scalp which shows evidence of alopecia without scarring or traumatic injury
3. Able and willing to make the required study visits.
4. Able and willing to give consent and follow study instructions.
5. Must speak, read and understand English

Exclusion Criteria:

1. History of bleeding disorders, anticoagulation therapy that cannot be stopped 14 days prior to injection
2. Allergic to lidocaine, epinephrine, valium or sodium phosphate
3. Individuals with a propensity for keloids
4. Individuals with diminished decision-making capacity will not be included in this research study
5. Current use of anti-inflammatory or anticoagulation medications that affect bleeding or are for bleeding disorders. These include: Plavix, Warfarin (Coumadin, Jantoven, Marfarin). In addition, if any of the following medicines are used two (2) weeks prior to surgery the patient will be ineligible.
6. Use of concomitant treatments, including topical medications, oral medications, meso-therapy, non-ablative fractional laser treatment, low-level laser therapy, interfollicular PRP injection and hair transplantation within the preceding 6 months.
7. All smokers and other tobacco users.
Munich Long COVID Registry for Children, Adolescents, and Adults

The MLC-R aims to create a large-scale registry that provides data on epidemiology, phenotypes, and disease trajectories of and health care for Long COVID at any age in Germany, which can be used for future clinical trials.

Infections with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have been observed in Germany since January 2020 and can result in acute coronavirus disease 2019 (COVID-19) as well as in long-term sequela, referred to as Long COVID. The umbrella term Long COVID comprises ongoing new SARS-CoV-2-associated symptoms later than four weeks from the onset of acute COVID-19. The term Post-COVID-Condition (PCC) was introduced by the WHO and stands for ongoing or new SARS-CoV-2-associated symptoms, which persisted for at least two months. These symptoms often include fatigue, brain fog, dyspnea, orthostatic intolerance, as well as exercise intolerance, with a worsening of symptoms after mild daily activities (post-exertional malaise, PEM). PCC can severely impair daily function, social participation, and health-related quality of life. The prevalence was estimated as up to 15% in infected people with pre-Omicron variants and lower with Omicron variants. Risk factors include female gender and pre-existing morbidity, with low risk in young children. The most severe form of PCC in people with initially mild or moderate COVID-19 is myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The prevalence of ME/CFS was shown to increase in the context of the pandemic. While progress has been made in deciphering the pathogenesis of acute COVID-19, the mechanisms of Long COVID/PCC are poorly understood. Increasing evidence indicates that remaining viral particles, as well as inflammation, altered microcirculation, dysfunction of the autonomic nervous system, and/or autoimmunity, may contribute.

With the web-based German MLC-R, we aim at deep phenotyping of PCC, identification of subtypes and risk factors, describing trajectories of the disease and patient journeys, and providing clinical data for future clinical trials. Patients are also invited to contribute biosamples for future translational research.

Eligibility Criteria:
Inclusion Criteria:

I. Written informed consent of the patient or legal guardian.

II. Confirmed SARS-CoV-2 vaccination and/or confirmed or probable SARS-CoV-2 infection: Positive SARS-CoV-2 polymerase chain reaction (PCR) or rapid antigen test (AST), documented probable COVID-19 (e.g., typical CT scan), probable COVID-19 with a history of high-risk contact, anti-SARS-CoV-2-N antibodies (and/or in non-vaccinated people -S-IgG antibodies) following probable COVID-19.

III. Additional ICD-10 codes: U09.9!V: Suspected post-COVID-19 condition, unspecified; U12.9!V: suspected adverse reactions to COVID-19 vaccine use, unspecified (post-COVIDvac condition).

Exclusion Criteria:

* Any subsequent medical data that question the diagnosis of PCC or post-COVIDvac condition
* Clinical picture can be explained by another underlying disease.
* Pregnancy