cyrilzakka/clinical-trials huggingface dataset:
Comparison of Vortioxetine Versus Other Antidepressants With Pregabalin Augmentation in Burning Mouth Syndrome

Background: The treatment of Burning Mouth Syndrome (BMS) presents a challenge in tailoring appropriate medication for individual patients. Antidepressants have demonstrated efficacy in alleviating symptoms in most cases; however, a subset of patients exhibit limited or no response to these treatments. The augmentation with pregabalin to conventional treatment has shown promising outcomes in relieving pain and improving quality of life in chronic pain conditions. This study aimed to compare the efficacy of vortioxetine with other antidepressants (SSRIs/SNRIs) in combination with pregabalin in a cohort of unresponsive BMS patients and to predict treatment response using clinical data.

Methods: A 52-week randomized, open-label, active-controlled study was conducted, enrolling 203 BMS patients previously treated with one antidepressant for 12 weeks and non-responder to the treatment. The study sample have included two groups: Group A (136) received vortioxetine, while Group B (67) received SSRIs/SNRIs. Pregabalin (75mg/day) was added to both groups, with a potential dosage increase to 150mg/day for inadequate responders after 12 weeks.

Treatment response was assessed by measuring reduction in VAS and SF-MPQ scores (\>50 or 1-2) and HAM-A and HAM-D scores (\>50% or ≤7) at 12, 24, 36 and 52 weeks. Classical logistic regression with a stepwise algorithm and Random Forest machine learning models were used to predict treatment response.


Eligibility Criteria:
Inclusion Criteria:

* patients with a confirmed diagnosis of BMS based on the International Classification of Orofacial Pain, 1st edition \[International Classification of Orofacial Pain, 1st edition (ICOP) Cephalalgia, 2020\]
* patients of any race or gender; complaining of oral burning recurring daily for \>2 h per day for \>3 months;
* normal blood test findings (including blood count, blood glucose levels, glycated hemoglobin, serum iron, ferritin and transferrin).
* BMS patients previously treated with one antidepressant for 12 weeks and non-responder to the treatment

Exclusion Criteria:

* the presence of any disease that could be recognized as a causative factor of BMS,
* a history of a psychiatric disorder or a neurological or organic brain disorder,
* a history of alcohol or substance abuse,
* the presence of Obstructive Sleep Apnea Syndrome (OSAS)
* uncontrolled hypertension, diabetes, HIV, narrow-angle glaucoma, or participants enrolled in other investigational studies.
* participants requiring continued treatment with medications that adversely interact with the study medications (eg, quinolone antibiotics, warfarin, agents inhibiting serotonin reuptake) or with hereditary problems of fructose intolerance, glucose galactose malabsorption, or sucrose isomaltase insufficiency
* pregnancy and lactation were exclusion criteria, and women of childbearing potential were required to receive a highly effective form of contraception.
Efficient Self-management of Chronic Disease Using Health Information Technology - a Study on Hypertension

Background:

Hypertension is an increasing global problem and measures are needed against the emerging hypertensive burden. Management of the risk factor hypertension consists of medical treatment in conjunction with lifestyle adjustment, whereby lifestyle adjustment is the preventive cornerstone but has also been proven to contribute to BP reduction among those already receiving medical drug treatments. Non-adherence is a significant barrier to successful hypertension management.

Goal:

To improve management of hypertension in daily life from a person-centred perspective, utilizing information and communication technology, and further to decrease complications of hypertension. To increase the proportion of persons with hypertension obtaining a BP goal =\<140/90 mmHg and to conduct a health economic evaluation of our intervention.

Plan:

The investigators will conduct a multi-centre randomized controlled trial in 36 primary care centres in three counties in Sweden. There will be approximaely 430 patients in each group. BP will be measured in a standardized manner, laboratory tests taken and questionnaires answered at baseline, after eight weeks and after a year in both the intervention and the control group. Register data on health care resource one year before baseline and for the full study period will be retrieved for participants in both study groups.

Singificance:

The intervention is expected to improve adherence to treatment and a significant lowering of the blood pressure. Hospitalization rates are lower among persons with hypertension that adheres to their medication. By improving treatment of hypertension the hope is to decrease complications and morbidity due to hypertension and thereby hospitalization and health care costs. Due to the generic nature of the technology involved, the self-management system can easily be adapted to monitor other chronic conditions.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Diagnosis of hypertension
* On treatment with at least one antihypertensive drug
* Understanding of Swedish in order to be able to provide informed consent and to make use of the mobile phone based self-management support system.
* Mobile phone (patients will use their own mobile, but have the possibility to borrow one if needed)
* Patient at a primary healthcare centre in any of four participating healthcare regions in Sweden (Skåne, Västra Götaland, Östergötland, and Jönköping)

Exclusion Criteria:

* Secondary hypertension
* Terminal illness
* Pregnancy-induced hypertension
* Cognitive impairment
* Impaired vision (not able to read messages on mobile phone)
* Psychotic disease
Utility of Sortilin as a Biomarker of Restenosis After Lower Extremity Endovascular Revascularization

Sortilin is a 95-kDa protein related to circulating cholesterol. It is found inside different cell types and circulating in blood and it has been associated with the risk of atherosclerosis development and cardiovascular diseases.

The goal of this observational study is to evaluate the potential use of circulating sortilin as a biomarker of vascular adverse outcomes in patients with peripheral artery disease (PAD) and chronic limb-threatening ischemia (CLTI) requiring a procedure of endovascular revascularization.

The main questions it aims to answer are:

* association between sortilin serum levels and risk of restenosis after lower extremity revascularization.
* association between sortilin serum levels and acute limb ischemia, major vascular amputations, and limb-threatening ischemia needing for urgent revascularization after lower extremity revascularization.

Patients with PAD and CLTI requiring lower extremity endovascular revascularization will undergo blood sampling for the dosage of circulating sortilin before the endovascular procedure.

Incidence of restenosis and acute limb ischemia, major vascular amputations, and limb-threatening ischemia needing for urgent revascularization will be collected in a 12-months follow-up and will be associated with sortilin serum levels at baseline.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes mellitus diagnosis;
* Ankle/Brachial Index (ABI) of less than 80;
* at least one lower limb stenosis greater than 50% documented by Ultrasound Color Doppler (US);
* stage 4 or 5 PAD diagnosis according to the Rutherford classification;
* presence of chronic limb threatening ischemia;
* indication for LER of the target arterial stenosis.

Exclusion Criteria:

* statin therapy within the previous 3 months;
* revascularization of the lower limb in the previous 3 months;
* diabetic foot ulcers with signs of active infection or osteomyelitis;
* diabetic peripheral neuropathy;
* homozygous familial hypercholesterolemia;
* absolute contraindication to antiplatelet therapy;
* thrombophilia;
* active cancer;
* active autoimmune disease;
* liver disease at functional status B or C according to Child-Pugh.
COMBINATION OF LYMPHATICO-VENULAR ANASTOMOSIS AND LIPOSUCTION IN TREATING LYMPHEDEMA

* cooperation of an International team with many years of experience in surgical management of lymphedema
* description of an effective surgical strategy to treat cancer-related lymphedema, a high incidence pathology
* the combination of LVA and liposuction guarantees long lasting results

Cancer-related lymphedema represents one of the major complications of cancer treatment, especially for breast and gynecologic cancers. Moreover, it has high impact on cancer survivors and healthcare systems. Lymphedema management still remains challenging. The better understanding of lymphedema physiopathology as well as the development of sophisticated surgical and diagnostic techniques have led to effective strategies to address lymphedema patients but, despite the considerable interest in international literature, no consensus exist.

The authors present a retrospective analysis of 24 consecutive patients affected by cancer-related lymphedema treated by the combination of LVA and liposuction in the same surgical session. Patients data regarding limb volume, lymphangitis rate and quality of life index were assessed before surgery and 1 year after surgery.

One year after surgery an average volume reduction of 37,9% was registered. Lymphangitis rate significantly decreased after surgery to 0.95 per year. Quality of life score improved.

CONCLUSIONS The combination of LVA and liposuction represents an effective strategy in treating patients with cancer-related lymphedema, ensuring a significant decrease in volume and reduction of lymphangitis rate as well as stable results in time. In addition, it appears to be minimally invasive and well tolerated by patients, since it can be performed under local anesthesia with low risk of complications.

Eligibility Criteria:
Inclusion Criteria:

previous lymphadenectomy

Exclusion Criteria:

free from cancer related pathology
Functional Innovation and Application Research of Domestic Advanced Low-Dose DSA/CT-DSA

The goal of this clinical trial is to learn if Generative AI Based Puncture Surgery Navigation System (GPS) can guide lung puncture in adults better. It will also learn about the quality improvement of cone beam CT (CBCT) by GPS. The main questions it aims to answer are:

* Does GPS lower the number of punctures, radiation dose, and complications of participants undergo percutaneous lung puncture?
* Does GPS improve the quality of CBCT images? Researchers will compare GPS to a conventional CBCT guided percutaneous lung puncture to see if GPS can improve the efficacy of lung puncture.

Participants will:

* Take the percutaneous lung puncture by the guidance of GPS or conventional CBCT (placebo)
* The number of punctures, the success rate of the procedure, the radiation dose, intraoperative complications and postoperative complications at 7 days will be recorded
* The images of CBCT will be collected


Eligibility Criteria:
Inclusion Criteria:

* Participants who require CBCT-guided precutaneous lung puncture (PLP) and meet the clinical indications for the procedure.
* Participants with pre-operation CT images available.
* Participants whose physical condition is suitable for PLP.

Exclusion Criteria:

* Participants have metallic implants in the body, which severely affects the image quality.
* Participants with a history of allergy or serious adverse reactions to iodine contrast media or other related drugs.
* Participants are pregnant or breastfeeding.
* Participants are unwilling or unable to sign informed consent.
Spinal Anesthesia Facilitated Sexual Intercourse As A Treatment Option For Vaginismus

Painful sex continues to be a relationship issue and can lead to marital dys-harmony. Other consequences include infertility, low self-esteem, depression and anxiety.Our study shows that spinal anesthesia is an effective last resort management option in women with vaginismus. As a one-off treatment spinal anesthesia provides hope for such couples and brings about a positive change in their relationships.


Eligibility Criteria:
Inclusion Criteria:

* Virgin married women with non-consummation of marriage for more than two years due to vaginismus

Exclusion Criteria:

* partners reported erectile dysfunction
* who had vulvar skin conditions (e.g. lichen sclerosus)
* vulvovaginal and urinary tract infections
* endometriosis.
Safety and Efficacy of EXC 001 in Subjects Who Have Participated in Prior Studies of EXC 001

The purpose of this study is to provide subjects who participated in prior studies of EXC 001 the opportunity to have their hypertrophic scars surgically revised and treated with EXC 001.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults who have participated in previous studies of EXC 001.
* Healthy adults who have chosen to have their scars revised.

Exclusion Criteria:

* Currently pregnant or pregnant during the 6 months prior to inclusion in the study, or breast feeding.
* Participation in another clinical trial within 30 days prior to the start of the study.
Safety and Immunogenicity Study of Candidate HIV-1 Vaccine Given to Healthy Infants Born to HIV-1-infected Mothers

Objectives:

Primary: Safety and immunogenicity of MVA.HIVA vaccine in 20-week-old healthy Kenyan infants born to HIV-1-infected mothers.

Secondary:

* HIV-1 immunogenicity comparison between MVA.HIVA and age-matched unvaccinated control arms in each cohort (breastfeeding or formula feeding)
* HIV-1 immunogenicity comparison between breastfeeding and formula feeding infants receiving MVA.HIVA
* HIV-1 immunogenicity comparison between breastfeeding and formula feeding infants in the age-matched unvaccinated control group
* Comparison of responses to certain Kenyan Extended Programme on Immunization (KEPI) vaccines (OPV, DTP, HBV, and HiB) between MVA.HIVA versus age-matched unvaccinated controls in each cohort, between breast versus formula feeding infants in the age-matched unvaccinated control group, and between breast versus formula infants receiving MVA.HIVA
* Comparison of immune activation and phenotypic profile of lymphocytes between breast and formula feeding infants in each cohort (MVA.HIVA and age-matched unvaccinated control)
* Build capacity for Infant HIV-1 Vaccine Clinical Trials Centre in Nairobi, Kenya.


Eligibility Criteria:
Infant Inclusion Criteria

* Healthy infants
* \< 3 days of age (day of birth = Day 0) at enrolment
* Birth weight \> 2500 grams
* Born to an eligible woman
* Written informed consent by parent

Infant Exclusion Criteria

* HIV infection, as determined by a filter paper and/or RNA test prior to vaccination.
* Participation in any other HIV-1 vaccine or drug trial.
* Failure to receive all standard KEPI immunizations according to national immunization programme.
* Weight for age z-scores outside of 2 standard deviations of normal at the time of vaccination.
* Acute disease at the time of vaccination (acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory tract infection with or without low-grade febrile illness, i.e., temperature of \<37.5 °C).
* Axillary temperature of ≥ 37.5 °C at the time of vaccination.
* Any clinically significant abnormal finding on screening from biochemistry or haematology by the time of vaccination.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g., egg products.
* Presence of any underlying disease that compromises the diagnosis and evaluation of response to the vaccine.
* Any other on-going chronic illness requiring hospital specialist supervision.
* Administration of immunoglobulins and/or any blood products within one month preceding the planned administration of the vaccine candidate.
* Any history of anaphylaxis in reaction to vaccination.
* Research Physician's assessment of lack of willingness by parents to participate and comply with all requirements of the protocol, or identification of any factor felt to significantly increase the infant's risk of suffering an adverse outcome.
* Likelihood of travel away from the study area.
Feasibility and Acceptability Study of the "O'Dide" Application in People Suffering From an Addiction

Substance Use Disorders (SUD) are associated with cognitive schemas that lead to care attrition and mistrust towards care. Considering this within SUD management, it is important to establish a confident relation between the patient and the care team to favorize acre observance. However, it demands an important availability of the healthcare team, allowing for frequent interactions at all times, including at night and during days off. With the present study, the investigator postulated that an application called Ô DIDE for Digital Interaction for Detoxification Engagement, that aims to help the caregivers maintaining a link with the patient in order to facilitate confidence in the relationship, could favorize care observance especially consumption report.

The present research aims to assess the feasibility of the "Ô DIDE" application after 8 weeks of use by patients treated for a disorder related to substance use at the Toulouse University Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Suffering from any type of addiction, with an active addiction requiring weekly monitoring of consumption
* Possessing an Android smartphone or having access to an Android smartphone and having access to an internet connection
* Able to read and understand French
* Affiliated or beneficiary of a social security scheme.
* Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).

Exclusion Criteria:

* Patient with cognitive or psychiatric disorders that may affect their ability to consent
* Participation in another protocol involving a modification of the treatment for addiction
* Person under legal protection, guardianship or curatorship
* Known or suspected pregnancy
Cefiderocol and Ampicillin-sulbactam vs. Colistin +/- Meropenem for Carbapenem Resistant A. Baumannii

Patients with bloodstream infections, hospital acquired pneumonia or ventilator-associated pneumonia caused by carbapenem-resistant Acinetobacter baumannii (CRAB) treated with cefiderocol combined with ampicillin sulbactam will be compared to patients treated treated with colistin alone or colistin combined with meropenem.

This will be a prospective controlled clinical study with historical controls.

In the prospective CASCADE study consecutive consenting patients with bloodstream infections, hospital acquired pneumonia or ventilator-associated pneumonia will be treated with cefiderocol combined with ampicillin sulbactam in 3 hospitals in Israel and 2 hospitals in Italy, all endemic for CRAB. We plan to recruit 150 patients into this prospective studies.

The CASCADE cohort will be compared to patients treated for the same types of infection in two recently completed randomized controlled trials (AIDA and OVERCOME). These trials compared between treatment with colistin vs. treatment with colistin-meropenem combination therapy, both finding no difference between treatment groups among patients with carbapenem-resistant Acinetobacter baumannii (CRAB) pneumonia. Thus, patients in CASCADE will be compared to all patients with CRAB bloodstream infections, hospital acquired pneumonia or ventilator-associated pneumonia in these randomized controlled trials.

Eligibility Criteria:
Inclusion Criteria:

Adults \>18 years with bacteremia or hospital-acquired pneumonia (HAP)/ ventilator-associated pneumonia (VAP) (Table 3) caused by carbapenem-resistant A. baumannii (CRAB) (meropenem and/ or imipenem minimal inhibitory concentration (MIC) \>8 μg/mL) susceptible to cefiderocol (disc zone diameter \>=17 mm, corresponding to an MIC \<2 μg/mL). We will include CRAB regardless of colistin, ampicillin-sulbactam, minocycline, tigecycline, trimethoprim/sulfamethoxazole and/or aminoglycoside susceptibility of the isolate. Attribution of the HAP/ VAP to CRAB will be allowed with isolation of CRAB from any respiratory sample within 7 days prior to the clinical diagnosis of pneumonia.

Exclusion Criteria:

* More than 72 hours of therapy with in-vitro coverage against the CRAB within 96 hours of enrolment
* Polymicrobial carbapenem-susceptible infections: growth of other pathogens susceptible to carbapenems, or another beta-lactam, deemed clinically-significant by the treating physicians in blood or sputum (with HAP/ VAP). We will allow recruitment of patients with other carbapenem-resistant Gram-negative bacteria
* CRAB susceptible any beta-lactam other than cefiderocol
* Coronavirus 2019 (COVID-19) co-infection
* Immediate-type hypersensitivity to penicillin
* Pregnant women
* Previous participation in the trial
* Lack of informed consent, considering the procedures acceptable to ethics committees per locale, including deferred consent
* Infection requiring treatment for over 14 days, at the discretion of the investigators
* Life expectancy less than 24 hours or expected futility of antibiotic treatment
Everolimus and Letrozole as Preoperative Therapy of Primary Breast Cancer in Post-menopausal Women

The purpose of this study is to examine the effect of the combination of everolimus and letrozole compared to placebo and letrozole as pre-surgical therapy in patients with newly diagnosed estrogen receptor positive breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically-confirmed diagnosis of invasive breast cancer, previously untreated
* Patients must be postmenopausal
* Candidates for mastectomy or breast-conserving surgery
* Primary tumor of above 2 cm diameter, measured by imaging
* Clinical Stage M0
* WHO performance status ≤1
* Adequate bone marrow, liver, and renal function

Exclusion Criteria:

* Multicentric invasive tumors
* Bilateral or inflammatory breast cancer
* Receiving concomitant anti-cancer treatments such as chemotherapy
* Patients with an uncontrolled infection
* Patients with other concurrent severe and/or uncontrolled medical disease

Additional protocol-defined inclusion/exclusion criteria may apply.
The Effect of a Developed Perioperative Rehabilitation Pathway Following Lumbar Arthrodesis

To compare the current rehabilitation pathway with the implementation of a newly developed rehabilitation pathway for patients with a single and double level lumbar arthrodesis.

This involves a prospective interventional study with a one year follow-up. The investigators will compare the outcomes of the current rehabilitation pathway with a newly developed (based on systematic review and delphi study) rehabilitation pathway for patients with a single and double level lumbar arthrodesis. The usual care group (n= 30) will be compared with the intervention group (n= 30).

Eligibility Criteria:
Inclusion Criteria:

* Lumbar single and double level arthrodesis
* Signed informed consent
* Posterior Lumbar interbody fusion (PLIF), Posterolateral lumbar fusion (PLF) and Transforaminal lumbar interbody fusion (TLIF)

Exclusion Criteria:

* Previous arthrodesis in the lumbar spine
* Musculoskeletal disorders which interfere with functional outcome, f.e. severe lower limb problems not related to the lumbar surgery
* Presence of one of the following pathologies:Parkinson Multiple sclerose (MS), Cerebral vascular accident (CVA), Peripheral neuropathies, Circulatory disorders, Gout, Rheumatoid disorders, Neoplasia, Septic arthritis, Pregnancy, Vestibular disorder, Infectious diseases
* Accident at work or lawsuit
* Low cognition
* Not able to speak Dutch