cyrilzakka/clinical-trials huggingface dataset:
Single Transpulmonary Thermodilution and Continuous Monitoring of Central Venous Oxygen Saturation During Off-pump Coronary Surgery

The aim of the present study was to evaluate the usefulness of an algorithm based on hemodynamic parameters obtained by single transpulmonary thermodilution (STD) combined with continuous monitoring of central venous oxygen saturation (ScvO2) for perioperative management of patients undergoing OPCAB.

At the present time, there is an increasing tendency to perform off-pump coronary artery bypass grafting (OPCAB). However, OPCAB poses a variety of challenges from the point of view of the anesthesiologist and the intensivist. The aim of the present study was to evaluate the usefulness of an algorithm based on hemodynamic parameters obtained by single transpulmonary thermodilution (STD) combined with continuous monitoring of central venous oxygen saturation (ScvO2) for perioperative management of patients undergoing OPCAB.

Eligibility Criteria:
Inclusion Criteria:

* Patients with coronary artery disease, ranked ASA II-III and scheduled for elective OPCAB

Exclusion Criteria:

* Age \< 18 years
* Severe valve dysfunction or peripheral vascular disease
* Simultaneous interventions (carotid endarterectomy, aneurysm repair, etc.)
* Transfer to CPB during surgery
Clinical Assessment of the Effectiveness and Safety of Herpes Patch SOS in the Treatment of Herpes Simplex Labialis in Comparison to a Competitor's Product.

Recent clinical studies showed, that a hydrocolloid patch is effective, well tolerated and comparable with aciclovir cream 5 % for the treatment of HSL lesions, while affording additional benefits of wound protection, discretion and relief of social embarrassment. The aim of the actual study was the clinical assessment of the effectiveness and safety of Hansaplast® SOS Herpes Patch (HPHP) in comparison to Compeed® Herpes Vesicle Patch (CHP) in treating HSL. Both products are CE-certificated and are available at the market for medical devices.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* with a history of recurrent HSL of the lips and/or perioral skin
* lesions typically manifesting as classical lesions
* duration of HSL symptoms not more than three days
* haven´t used acyclovir or other cold sore therapies

Exclusion Criteria:

* pregnancy
* lactating women
* women of child-bearing age without medically secured contraceptions
* topical or systemic therapy with analgesic
* anti-inflammatory or antiviral agents within the last 2 weeks
* topical therapy within the treatment area
* systemic therapy with cytostatics or immunosuppressants
Observational Study of Baska Mask, a New Supraglottic Airway Device in Children

The investigators wish to accumulate initial data on the performance and safety of the Baska mask in paediatric patient population.


Eligibility Criteria:
Inclusion Criteria:

* consent
* BMI 15-35
* weight over 30kg or age 8-16 yrs
* non-urgent surgery of planned duration up to 2 hrs

Exclusion Criteria:

* neck pathology
* previous or anticipated problems with the upper GI or upper airway
* increased risk of gastric aspiration
* expected difficult airway
Clinical Study of High-intensity Focused Ultrasound Tumor Treatment System(Super Knife) in the Treatment of Breast Cancer

Breast cancer is the most common cancer diagnosed among women and is the second leading cause of cancer death among women after lung cancer. The treatment methods of breast cancer include surgery, chemotherapy, radiotherapy and so on. The investigators discover a High-intensity focused ultrasound therapy to treat breast tumor, which is a non-invasive method.


Eligibility Criteria:
Inclusion Criteria:

ECOG Performance Status of 0-1; Histological confirmed invasive breast cancer; Breast cancer tumor measuring ≥2 cm in maximal diameter and a single lesion as measured by mammogram, breast ultrasound, or breast MRI; Breast tumor's borders from the skin are greater than 1 cm; No lymph node or distant metastasis; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, Platelets ≥ 50 × 109/L, Hemoglobin ≥ 9.0 g/dl iv; Serum creatinine ≤1.5 x upper limit of normal (ULN); AST ≤ 2.5 x ULN, ALT ≤ 2.5 x ULN; Left ventricular ejection fraction ≥ 50%.

Exclusion Criteria:

Inflammatory breast cancer, bilateral breast cancer, or occult breast cancer; Any kind of prior treatment for breast cancer, including chemotherapy, radiotherapy, endocrine therapy and so on; Pregnant and lactating women; Patients who have participated in other clinical trials.
GENetic Fronto Temporal Dementia Initiative in Lille

GENFI Lille is a French cohort that belongs to the international initiative GENFI2, a five year longitudinal biomarker cohort study of genetic FTD and its associated disorders (including MND/ALS) investigating members of families with a known mutation in GRN or MAPT or an expansion in C9orf72 (including those affected with the disorder as well as at-risk members of families).

The purposes of this study is :

* to improve characterization of symptomatic FTD patients or presymptomatic subjects at risk of genetic FTD
* to develop markers indicative of the optimal time to start disease-modifying therapy, based on the proximity to clinical onset.
* to develop markers of disease progression that can be used as outcome measures.
* to derive sample size estimates for clinical trials.

Participants will include those affected with the disorder as well as at-risk members of families (both mutation carriers and non-carrier first-degree relatives who will serve as a control group).

All participants will be assessed longitudinally with a set of clinical, neuropsychiatric, cognitive, imaging and biosample protocols.

Eligibility Criteria:
Inclusion Criteria:

* The participant must be 18 years old or older.
* The participant must be a member of a family with a known pathogenic mutation in the GRN or MAPT genes, or with a pathogenic expansion in the C9orf72 gene :

  * An affected member is one who has been clinically diagnosed by a neurologist as having frontotemporal dementia or a disorder in the FTD spectrum.
  * An at-risk member is one who is a first-degree relative of a family member affected with the disease.
  * Pathogenicity of a GRN or MAPT mutation is defined by those included within the GENFI list of FTD mutation. If a novel mutation is discovered that is likely to be pathogenic and has not yet been included within the FTD mutation database then the GENFI Genetics Core will decide on inclusion. Please send an email to the GENFI Trials Team at genfi@ucl.ac.uk.
  * A pathogenic C9orf72 expansion is defined as greater than 30 repeats. Intermediate expansions are not considered pathogenic.
  * Participants from one of the small number of families around the world in which 2 (or more) pathogenic mutations have been found should not be included in GENFI.
* If the participant is demented or cognitively impaired there must be an available caregiver that can escort them.
* The participant must have an identified informant.
* The participant must be fluent in the language of their country of assessment.
* The participant accepts that genetic analysis will be carried out on his/her blood samples, and that no results will be available neither for the investigator nor for the participant.

Exclusion Criteria:

* Participant has another medical or psychiatric illness that would interfere in completing assessments.
* Contraindications to FDG-PET (allergy to FDG...)
* Participant is pregnant.
IMPACT OF BREATH CONTROL AND RETENTION ON PATIENT STRESS. E.S IN MEDICALLY ASSISTED REPRODUCTION

the investigator propose for patient in the course of Medically Assisted Reproduction a study with to arm: one arm active "Breathing Control and Retention" and the other arm control

After signing the informed consent, the patient makes an appointment for an exchange with the psychologist at the Reproduction center.

During this exchange, the psychologist gives him the evaluation scales, explains to him when to complete them and re-explains the progress of the study.

Patients in the active "Breathing Control and Retention" group make 4 appointments, one week apart, with the Bluenery Academy. The participants self-assess 2 days before starting the breathing program (M0), 2 days after the end of the program, 1 month after starting the program (M1).

Patients in the "Usual follow-up" control group complete the self-assessments 2 days after the discussion with the psychologist (M0) and 1 month later (M1).

At the end of the 2 assessments, the patient was included. sends his assessment book to the psychologist.

An appointment will be made after the rating to communicate the results to them.

Eligibility Criteria:
Inclusion Criteria:

* Unmarried woman and couple of women with societal infertility,
* couple with medical infertility defined as absence of pregnancy after 12 months without contraception,
* age greater than 18 years,
* patient who has signed informed consent and affiliated to social security.
* Patient available at the proposed slots over 4 weeks

Exclusion Criteria:

* pregnant women before starting the program,
* heart failure
* Thrombocytopenia
* epilepsy
Psychological Management by Meditation of Full COnscience in Virtual REality of People With Amyotrophic Lateral Sclerosis: Effects on Cognition, Behavior, Quality of Life and Psychological Well-being

Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease that results in progressive paralysis of the muscles involved in voluntary motor skills, speech, swallowing and breathing. It also causes non-motor symptoms including psychological, cognitive and behavioral difficulties that have a negative impact on patients' quality of life, well-being and long-term development. There is no curative therapy for ALS and drug treatments have little effect on non-motor symptoms. Interventions based on mindfulness meditation, defined as a state of consciousness that arises when one decides to focus attention in the present moment without judgment on the real experience, seem to be a promising tool for the reduction of non-motor symptoms in a number of progressive neurological conditions (Alzheimer's disease, multiple sclerosis, etc.), suggesting that mindfulness significantly helps in the management of these symptoms. Our project therefore aims to implement a mindfulness meditation program adapted to the management of non-motor symptoms in ALS based on virtual reality (VR).


Eligibility Criteria:
Inclusion Criteria:

* Majors to inclusion
* Mother tongue: French
* Patients for whom ALS of bulbar or spinal form defined according to El Escorial criteria is possible, probable or certain
* Able to carry out the investigations and interventions provided for in the protocol
* Signature of informed consent to participate in the study

Exclusion Criteria:

* Participation in intervention research modifying management
* History likely to disrupt cognition (constituted stroke, sequelae of traumatic brain injury, active epilepsy, learning disabilities, alcohol dependence syndrome, drug use, psychiatric disorders), severe cognitive impairment (MMSE \<24)
* People who meet the diagnostic criteria for Frontotemporal Dementia
* Pregnant or lactating women
* Persons deprived of their liberty by administrative or judicial decision
* Persons undergoing psychiatric care under duress
* Persons subject to a legal protection measure
* Persons unable to express their consent
* Persons not affiliated or not beneficiaries of a social security scheme
Safety and Effectiveness of Acthar Gel for Inflammation of the Eye's Uvea (Middle Layer)

The main reason for this study is to see if Acthar Gel can reduce inflammation in the uvea.

Also, safety information when using it for this purpose will be collected.


Eligibility Criteria:
Inclusion criteria:

* Is male or nonpregnant, nonlactating female
* Has been diagnosed with current severe NIPPU
* Has active disease at the Baseline Visit as defined by the presence of at least 1 of the following parameters in at least one eye despite at least 2 weeks of maintenance therapy with oral prednisone (or oral corticosteroid equivalent):

  1. Has active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion
  2. Has ≥ 2+ anterior chamber cells \[Standardization of Uveitis Nomenclature (SUN) criteria\]
  3. Has ≥ 1.5+ vitreous haze
* Is willing to taper current doses of corticosteroid and immunomodulatory therapy to the minimum effective dose during the study.
* If under treatment with any immunosuppressants, immunomodulators, or biologic agents for a comorbid condition, has been on a stable dose for 2 weeks before screening

Exclusion criteria:

* Has proliferative or severe nonproliferative diabetic retinopathy, clinically significant macular edema due to diabetic retinopathy, neovascular/wet age-related macular degeneration, abnormality of vitreoretinal interface with the potential for macular structural damage independent of the inflammatory process or severe vitreous haze that precludes visualization of the fundus at the Baseline Visit
* Has Type 1 or Type 2 diabetes mellitus, tuberculosis, history of hepatitis, peptic ulcer, active infection, or any contraindication for treatment with Acthar Gel
Effect of UDCA on the New Onset Diabetes and Glucose Intolerance Induced by Statin

At present, it is recognized that statins are the cornerstone of treatment for the prevention of major cardiovascular events in patients with atherosclerotic cardiovascular disease (ASCVD); However, at the same time, the increased risk of long-term glucose tolerance and type 2 diabetes mellitus caused by statin therapy has attracted wide attention. The investigators' recent study found that the levels of glycosylated hemoglobin, insulin and C-peptide increased significantly with the extension of follow-up time in patients with hyperlipidemia. At the same time, serum and fecal bile acid metabolism profiles, especially secondary bile acid metabolism, were extensively changed, especially in ursodeoxycholic acid (UDCA), suggesting that the decrease of UDCA is a possible mechanism for statins to induce side effects of diabetes. According to this hypothesis, ursodeoxycholic acid combined with statins may improve the abnormal glucose tolerance caused by statins and maximize the benefit of statins. This study is a multicenter, prospective, randomized, parallel, double-blind placebo-controlled, cohort study. Taking ASCVD patients as the research object, the investigators will compare the changes of glycosylated hemoglobin, fasting blood glucose, fasting insulin, C-peptide and metabolomic indexes before and after the use of ursodeoxycholic acid combined with atorvastatin and atorvastatin alone and during follow-up, Further evaluate the changes of blood glucose related indexes before and after the use of ursodeoxycholic acid combined with atorvastatin and atorvastatin alone, clarify the possible mechanism and specific treatment targets of abnormal glucose tolerance caused by statin, and put forward a possible alternative treatment for the disorder of glucose metabolism caused by statin.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old and \< 80 years old, regardless of gender;
* For those who had indications for taking statins for more than half a year, glycosylated hemoglobin increased by more than 0.5 and \> 6.1% compared with half a year ago;
* Agree to accept the study treatment plan and voluntarily sign the informed consent form.

Exclusion Criteria:

* previous diagnosis of diabetes mellitus;
* Received hypoglycemic drug treatment;
* The level of abdominal blood glucose at baseline was ≥ 7mmol / L;
* Need to take glucocorticoids for a long time;
* Acute myocardial infarction and stroke occurred in the last 6 months;
* Severe liver dysfunction;
* Glomerular filtration rate (EGFR) \< 30ml / min / 1.73m2 (MDRD formula);
* Malignant tumor;
* Blood system diseases;
* Acute or severe systemic infection;
* Women during pregnancy, lactation and preparation for pregnancy;
* Alcohol and other drug addicts and mental patients;
* Patients who are participating in other clinical studies or withdraw from less than 1 month;
Interaural Mismatch in SSD CI Users

Interaural loudness and pitch mismatch in single-sided deaf cochlear implant (SSD-CI) recipients reduces binaural processing cues and contributes to performance outcomes, specifically speech understanding in noise and localization. The study aims to improve binaural cues through speech processor program modifications that reduce interaural mismatches.

Effective binaural processing depends on similar loudness growth functions at each ear. The use of interaural level differences (ILDs), perceived as loudness differences, to locate sound is critical given the inability of cochlear implant (CI) recipients to use interaural time differences (ITDs) in binaural processing. In CI recipients with single-sided deafness (SSD), perceived interaural loudness differences may not be valid indicators of interaural level differences because the CI compresses amplitude. Studies suggest better preservation of ILDs may contribute to improved localization and understanding in noise. Since SSD-CI recipients use only one device, an approach to improve their use of ILDs is to match perceived loudness at each ear.

Binaural processing is also affected when signals of equal frequency are not matched in pitch at each ear. In bilateral CI recipients, the investigators found that the greater the pitch mismatch between ears, the poorer the speech understanding in noise. The investigators want to extend this work to SSD-CI recipients. Through CI program modifications, the study aims to decrease the pitch and loudness mismatch between the CI ear and the normal hearing ear to improve binaural listening abilities, specifically speech understanding in noise and sound localization.

Eligibility Criteria:
Inclusion Criteria:

* Participants for the proposed study will be adults with single-sided deafness. Participants will have at least 6 months experience with their cochlear implant or will be newly implanted with the cochlear implant.

Inclusion criteria for the experienced CI user group and the newly implant group are as follows:

* 18 years of age and older
* Postlingual onset of SSD
* Pure tone average (PTA) at 500, 1000, and 2000 Hz of less than or equal to 30 dB HL in the contralateral ear, known as the normal hearing ear
* Implanted with or chosen to be implanted with a Nucleus cochlear implant
* Full insertion of electrode array

Exclusion Criteria:

* • Not meeting the inclusion criteria
Investigation on Failure Time Analysis of a New TPE Material in the Iceform Liner

Durability evaluation of a new material blend in the Iceform liner and Iceform sleeve.

Potential subjects will be identified from the customer base of a relevant clinic. If a potential participant may fit the inclusion and exclusion criteria, he/she will be contacted by a Co-Investigator (CI) via telephone. During the telephone call the CI will verify if they are interested in participating in a study and will initiate the enrollment procedure. If interest is expressed at this point they will answer some screening questions and if the eligibility criteria is met the subject is offered to enroll by getting a study invite through ProofPilot, the EDS, and an appointment to come in for initial fitting will be set up. Questions relating to the duration of the study, number of clinical visits required, and the investigational device will be answered at this time.

Following this the subject will log into ProofPilot online and go through the e-ICF, if signed, the subject will answer a profile questionnaire.

The next step will be an appointment, subject comes into their clinic and gets the investigational device. In some cases, the subject will get the liner shipped to their home address. This will only be done upon subjects request due to long distance from clinic. And only for very confident prosthetic users which are used to handle a new liner by themselves.

Potential risk of participating in the investigation will be explained to the subject at this point. The CIs will communicate to the study monitors the number of users that have been identified that meet the inclusion/exclusion criteria and are willing to participate.

During the clinical visit the subjects will only be fitted to the Iceform investigational liner. Profile and relevant contact information will already have been collected via the EDS.

Subjects will then receive a prompt monthly, either via email, SMS or smartphone notification, to fill in the EDS questionnaire, and perform any tasks as applicable. If a subject reports a failure he/she will be instructed to stop using the liner, the remaining gift cards will be delivered and their participation ends. Otherwise, participation will end at 6 months.

The subject gets to keep the investigational device at the end of the study, therefore there is no need for an additional visit.

Subjects that report a failure of the TPE material may be contacted by the Coordinating Investigator or CI if the root cause of the failure cannot be confidently determined from the data collected with the EDS system.

Eligibility Criteria:
Inclusion Criteria:

* Trans-tibial amputee
* Uses an Iceform or Willow Wood Alpha Classic (Uniform profile) liner
* Willing and able to participate in the study and follow the protocol
* Confident prosthetic users for more than 3 months
* Older than 18 years

Exclusion Criteria:

* Participating in another research study
* Participants of another research study during previous 2 months.