cyrilzakka/clinical-trials huggingface dataset:
Effect of Dapagliflozin on Vascular Functions in Patients With Type 2 Diabetes Compared to Gliclazide

The investigators set up a clinical trial to compare effect of dapagliflozin, a sodium glucose co-transporter 2 inhibitor, with gliclazide on vascular function in patients with type 2 diabetes

Obesity, and especially visceral/abdominal adiposity, is associated with diabetes and increased cardiovascular risk. In previous randomized, double-blind, placebo-controlled study, dapagliflozin reduced total body weight, predominantly by reducing fat mass, visceral adipose tissue and sc adipose tissue in type 2 diabetes. This study supported that caloric loss from glycosuria, and not fluid loss, was principally responsible for decrease in total body weight and fat mass. In fact, there have been several reports proving that inhibition of SGLT2 improves β-cell function and reduces body weight and blood pressure. However, effects of SGLT2 inhibitors on lipid profiles have not been decided yet in patients with type 2 diabetes. Furthermore, there are few data to demonstrate the effects of SGLT2 inhibitors on CV risk.

Many systems and pathways are involved in development of atherosclerosis in the arterial wall. Accumulating evidence suggests that endothelial dysfunction plays an important role particularly in the first stage of atherogenesis in patients with diabetes. Approaches designed to improve endothelial function may therefore have additional therapeutic value in the prevention and treatment of atherosclerotic disease. Endothelial dysfunction is related to decreased production and bioavailability of nitric oxide (NO). Endothelial function was measured through several circulating biomarker such as NO, endothelin-1 or non-invasive techniques such as flow-mediated dilation (FMD), skin laser doppler. Among them, FMD is known to as the optimal tool. In addition, several noninvasive techniques including measurement of the ankle-brachial index (ABI), carotid intima-media thickness (IMT) and pulse wave velocity (PWV) have been used for evaluation of atherosclerosis.

If a participant's HbA1c dose not decreas by \>0.4% at 12 weeks, rescue therapy can be added at the investigator's discretion.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes with HbA1c ≥ 7.5% at screening visit
* Male or female between 40 and 70 years of age
* Patients taking metformin (≥ 1000 mg or maximum tolerated dose) for more than 3 months
* BMI ≥23 kg/m²
* Estimated GFR ≥ 60 ml/min/1.73m²

Exclusion Criteria:

* Patients with acute coronary syndrome within 3 months prior to screening visit
* Pregnant or breast feeding women or reproductive-age women who refuse contraception
* Type 1 diabetes, gestational diabetes, or diabetes with secondary cause
* Chronic hepatitis B or C (except healthy carrier of HBV), liver disease (AST/ALT \> 3-fold the upper limit of normal)
* Cancer within 5 years (except squamous cell cancer, cervical cancer, thyroid cancer with appropriate treatment) except thyroid cancer or carcinoma in situ
* Other clinical trial within 30 days
* Alcohol abuse
* Contraindication to SGLT2 inhibitors or sulfonylurea
Heat and Moisture Exchanger and Low-flow Gas

The aim of the present study was to measure the inspired gas temperature and humidity of the anesthetic circuit in the Dräger Primus machine and esophageal temperature with or without and heat and moisture exchanger (HME) and low-flow gas during anesthesia in patients submitted to gynecological surgeries.


Eligibility Criteria:
Inclusion Criteria:

* Women
* 18 to 69 years old
* Gynecological

Exclusion Criteria:

* Obesity
* Fever
* Endocrine disease
Expectation, Motivation and Experience of HIV-patients Regarding Participation to an HIV Cure-related Clinical Trial

Following the ANRS-APSEC survey, AMEP-EHVA T02 is a longitudinal social science study that will explore the experience of people living with HIV (PLWH) who were offered to participate in the European randomized phase II placebo-controlled trial of vedolizumab with or without therapeutic HIV MVA vaccine including antiretroviral treatment interruption (EHVA T02/ANRS VRI07).

Moving towards the discovery of an HIV cure is of major public health interest, not only for people living with HIV (PLWH) who currently must take lifelong antiretroviral treatment (ART), with its associated side effects and comorbidities, but also for the community as a whole. An HIV cure will end the virus transmission, lead to global care-related savings and decrease in HIV-related stigma.

The present longitudinal social science study concerns the experience of PLWH who were offered to participate in the European randomized phase II placebo-controlled trial of vedolizumab with or without therapeutic HIV MVA vaccine including ART treatment interruption (EHVA T02/ANRS VRI07).

The objectives are to document:

1. the evolution over time of expectations and motivations related to participation in the trial,
2. anticipation and understanding of risks and benefits related to participation,
3. evolution over time of participation experience and of satisfaction with the information delivered,
4. experience and perception of the ATI period and its impact on preventive behaviours and sexual quality of life,
5. motivations and experience related to refusal of participation, or if any, related to non-inclusion because of negative screening results.

This international multicentre longitudinal study will be nested within the EHVA T02/ANRS VRI07 trial, and will comprise two components. A quantitative component designed to answer to the four first objectives, and a qualitative one that will retrospectively deepen the trial participation experience and will also document the motivation for participation refusal and the experience of participants not included because of negative screening results (objective 5). The quantitative survey will be conducted within participating centres that estimate to include at least 5 participants, and the qualitative one only in France for feasibility purpose.

Eligibility Criteria:
Inclusion Criteria:

* people living with HIV
* who were offered to participate in EHVA T02 clinical trial
Buphenyl Therapy for Byler's Disease

This is a single patient compassionate use protocol to determine whether Buphenyl (4-phenylbutyrate) will improve the poor bile flow associated with Byler Disease.


Eligibility Criteria:
Inclusion Criteria:

* Byler Disease
* Cholestasis unresponsive to pharmacologic therapy

Exclusion Criteria:

* Allergy/Hypersensitivity to Buphenyl
Assessment of Response to the Conventional Periodontal Treatment Based on the Blood Group Phenotypes.

The aim of this study is to find out if one blood group phenotype is more responsive than the others to the nonsurgical periodontal treatment.

To the best of our knowledge, this is the first (research) randomized clinical trial that assesses how patient respond to the nonsurgical periodontal treatment based on their blood group phenotype.

Eligibility Criteria:
Inclusion Criteria:

* systematically healthy.
* have at least 20 teeth excluding the third molars.
* had not received any periodontal treatment or antibiotic therapy for dental or medical reason 6 month prior to the study.
* diagnosed with generalized chronic periodontitis (\>30% of the sites have probing depth ≥4), and a minimum of six teeth with probing depth of 5-6 mm.

Exclusion Criteria:

* smokers and alcoholics.
* pregnancy.
* history of a systematic disease such as diabetes, leukemia, epilepsy.
* participants who are unable to perform routine oral hygiene.
* use of orthodontic appliances.
* participants who are unable to perform routine oral hygiene.
Liposomal Amikacin Inhalation in M.Abscessus Patients

Mycobacterium abscessus is one of the many species of non-tuberculous mycobacteria. M. abscessus infections are known to be common in patients with cystic fibrosis (CF). Mycobacterium abscessus yields poor cure rates. Liposomal amikacin inhalation (LAI) might be a good alternative for intravenous treatment as the first results with mycobacterium avium treatment yield good results.

The objective of this study is to summarize the clinical data of patients with M.abscessus treated with LAI on compassionate use basis to assess treatment outcomes


Eligibility Criteria:
Inclusion criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

* ATS diagnostic criteria for M.abscessus pulmonary disease
* \> 12 years
* Patients with CF/COPD or other underlying disease
* LAI use for more than 3 weeks

Exclusion criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

• Extra-pulmonary or disseminated disease
Combined Effects of Lion's Breath Technique With Chest Percussion Therapy in Pneumonia Patients

This study will be randomized controlled trial with non-probability convenient sampling. Sample size will be 90,45 in each group. Outcome will be measured by using 6 minute walk test, Spirometry (FVC, FEV1/FVC and PEF), Functional Independence Measure.

The main objective of the study is to determine the effect of lion's breath technique along with chest percussion therapy in pneumonia patients. This study will be randomized controlled trial with non-probability convenient sampling. Sample size will be 90,45 in each group. Participants included will be adults aged 18 years and above diagnosed with pneumonia. Willing to comply with the study protocol. Both male and female will be included. Participants should be in stable health conditions to participate in the Study. Patients with severe or life-threatening pneumonia requiring immediate intensive care and patients with physical or cognitive limitations. Patients with a history of chronic respiratory conditions such as COPD, bronchitis, or asthma. Pregnant or breastfeeding women. Individuals with musculoskeletal or neurological conditions and Patients with contraindications to chest percussion therapy, such as recent surgery or trauma to the chest area will be excluded. Group A (Lion's Breath Technique + Chest Percussion Therapy) Daily supervised Lion's Breath Technique sessions will be for 20 minutes for 1 week. Trained physiotherapists administer chest percussion therapy will be to mobilize secretions and improve lung function. Daily session for 30 minutes for 1 week. Pre and post data will be gathered. Outcome will be measured by using 6 minute walk test, Spirometry (FVC, FEV1/FVC and PEF), Functional Independence Measure.

Eligibility Criteria:
Inclusion Criteria:

* Patients in the post-acute phase of pneumonia recovery.
* Adults aged 18 years and above diagnosed with pneumonia.
* Both male and female will be included.
* Participants should be in stable health conditions to participate in the Study.
* Willing to comply with the study protocol

Exclusion Criteria:

* Patients with severe or life-threatening pneumonia requiring immediate intensive care
* Patients with physical or cognitive limitations
* Patients with a history of chronic respiratory conditions such as COPD, bronchitis, or asthma
* Pregnant or breastfeeding women
* Individuals with musculoskeletal or neurological conditions
* Patients with contraindications to chest percussion therapy, such as recent surgery or trauma to the chest area
Value of an Intrathecal Synthesis Index of Specific Antitreponema IgG for Neurosyphilis Diagnosis

A retro-prospective case-control Swiss study was conducted to evaluate the diagnostic performance of measuring an antibody index (AI) for intrathecal synthesis of specific anti-Treponema pallidum (T. pallidum) IgG for the diagnosis of neurosyphilis.

The diagnosis of neurosyphilis (NS) lacks a true "gold standard" which makes the diagnosis challenging while consequences of a misdiagnosis are potentially severe. The aim of this study was to evaluate the diagnostic performance of measuring an antibody index (AI) for intrathecal synthesis of specific anti-Treponema pallidum (T. pallidum) IgG for the diagnosis of NS.

CSF parameters were analysed and specific anti-T. pallidum IgG were measured simultaneously on paired cerebrospinal fluid (CSF)-serum samples collected between 2007 and 2022 from patients suspected of NS, in Switzerland. An AI was calculated to consider blood-brain barrier integrity. Two NS definitions were used: NS1 included patients with suspicion of NS presenting neurological symptoms and/or acute neuro-sensory signs and positive TPHA/TPPA serology and CSF-TPHA/TPPA≥320, and either CSF-leucocytes \>5cells/mm3 and/or CSF-protein \>0,45g/l and/or a reactive CSF-VDRL/RPR test. NS2 included patients with NS suspicion presenting acute ocular and/or otologic symptoms, and positive TPHA/TPPA serology, and a favourable response to NS treatment. Controls were patients diagnosed with any other CNS pathologies and with positive TPHA/TPPA serology.

Eligibility Criteria:
Inclusion Criteria:

* All patients who have serum / CSF sample pairs collected concomitantly (3 days maximum interval between blood test and lumbar puncture).
* Age \> or = 18 years old.

Exclusion Criteria:

* All patients for whom the stored samples do not meet the needs of the diagnostic study, or whose serum and CSF collection date is more than 3 consecutive days.
* Age \< 18 years old.
* No written consent form for the prospective part.
Ultrasound with Subharmonic Imaging and Subharmonic Aided Pressure Estimation (SHAPE) to Identify Portal Hypertension

This clinical trial tests the how well an ultrasound with subharmonic imaging and the subharmonic aided pressure estimation (SHAPE) technique works in identifying portal hypertension (PH). An ultrasound takes pictures of the inside of the body by bouncing sound waves off organs. PH is high blood pressure in the vein that carries blood to the liver from the stomach, small and large intestines, spleen, pancreas, and gallbladder. The complications associated with PH are clear only after severe liver dysfunction or liver cirrhosis develops and are accompanied by relatively high mortality rates (20-70% mortality within 2 years). Thus, identifying PH earlier is beneficial. The hepatic venous pressure gradient (HVPG) obtained using an invasive catheterization procedure remains the standard for assessing PH. However, using this invasive procedure to assess PH prevents frequent pressure monitoring. Thus, a noninvasive technique to estimate PH is beneficial not only for diagnosis but also for monitoring treatment and disease progression. The SHAPE technique is a noninvasive ultrasound-based imaging technique that can estimate pressure with an ultrasound contrast agent. A noninvasive technique using an ultrasound with subharmonic imaging and the SHAPE technique may work in identifying PH.

PRIMARY OBJECTIVES:

I. To evaluate if SHAPE with perflutren lipid microspheres (Definity) microbubbles identifies patients with clinically significant PH.

II. To evaluate if addition of subharmonic imaging-based perfusion parameters derived from time intensity curves and shear wave elastography (SWE) measurements increase the diagnostic confidence of detecting PH.

OUTLINE:

Patients receive Definity intravenously (IV) once on study. Additionally, patients undergo ultrasound with and without SHAPE technique as well as standard of care liver biopsy on study.

After completion of study intervention, patients are followed up for 30 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Provide signed and dated informed consent form
* Willing to comply with all study procedures
* Adult patients (age of 18 years or older)
* If a female of child-bearing potential, must have a negative pregnancy test
* Be scheduled for HVPG measurement

Exclusion Criteria:

* Patients who are unable to provide consent
* Females who are pregnant or nursing
* Patients with known or suspected hypersensitivity to perflutren lipid microsphere or its components, such as polyethylene glycol (PEG)
Development of Three-dimensional Deep Learning for Automatic Design of Skull Implants

This project aims to develop an effective deep learning system to generate numerical implant geometry based on 3D defective skull models from CT scans. This technique is beneficial for the design of implants to repair skull defects above the Frankfort horizontal plane.

Designing a personalized implant to restore the protective and aesthetic functions of the patient's skull is challenging. The skull defects may be caused by trauma, congenital malformation, infection, and iatrogenic treatments such as decompressive craniectomy, plastic surgery, and tumor resection. The project aims to develop a deep learning system with 3D shape reconstruction capabilities. The system will meet the requirement of designing high-resolution 3D implant numerical models efficiently.

A collection of skull images were used for training the deep learning system. Defective models in the datasets were created by numerically masking areas of intact 3D skull models. The final implant design should be verified by neurosurgeons using 3D printed models.

Eligibility Criteria:
Inclusion Criteria:

1. Scheduled for cranioplasty
2. Informed consent

Exclusion Criteria:

(1)No informed consent
Targeting High Risk Populations With Enhanced Reactive Focal Mass Drug Administration in Thailand

This study assesses the effectiveness of reactive focal mass drug administration (rfMDA), targeting both village and forest working populations, compared to control for reducing the health promotion hospital-level (sub-district) incidence and prevalence of P. falciparum and P. vivax within five provinces in Thailand.

Thailand currently has a well-developed and robust surveillance system based on detailed mapping of all cases to the village foci level and stratification of response. In fiscal year 2019, 5,833 cases of malaria were reported with 83.0% P. vivax and 12.9% P. falciparum; nine deaths were reported. This represents a 20.8% decrease in total cases from fiscal year 2018. Currently, there are 701 "A1" villages in 44 provinces.

The research proposed here will evaluate the effectiveness and feasibility of enhanced reactive focal mass drug administration, results of which will have direct implications for continued roll out the community-led foci management, providing practical guidance that other malaria programs can utilize. Responding to the malaria among high risk populations is a requirement from the National Malaria Elimination Strategy in Thailand. Additionally, Thailand has experienced outbreaks related to forest work over the past several years, and consequently the Department of Vector Borne Disease (DVBD) is interested in introducing more aggressive parasite elimination strategies, including rfMDA for P. falciparum and P. vivax specifically targeting high-risk populations to interrupt transmission and rapidly accelerate elimination.

Eligibility Criteria:
Inclusion Criteria for rfMDA:

* Index cases: Presented as a confirmed malaria case to an intervention health facility or village malaria worker, and lives in a village within a selected intervention subdistrict, or worked or spent at least one night at a forest or forest-fringe site in the past 30 days located within an intervention subdistrict
* Village residents: Lives in a village within a selected intervention subdistrict area and in one of the five households closest to the residence of an index case of malaria
* Co-worker/traveler referral: Worked or traveled and spent at least one night in forest in past 30 days in same location within an intervention subdistrict as an index case of malaria
* All participants: Willing and available to participate in the study and informed consent for participant under the age of 18 will be provided by the parent or guardian. Participants for focus group discussions (FGDs) and key informant interviews (KIIs); 18 years of age or older

Exclusion Criteria:

• For rfMDA:

* Previous participation in the study as a result of any rfMDA event in the past 30 days
* Individuals with severe disease or drug contra-indications will be excluded from the treatment component only
* Artesunate-Mefloquine: Pregnancy in the first trimester, or known drug allergy
* Use of Mefloquine within 60 days of first treatment prior to enrollment date.
Impact of Pretreatment Emotional Distress on Survival and the Predictive Role of Peripheral Biomarkers in Immunotherapy Response Among Gastroesophageal and Lung Cancer Patients

This is the prospective, observational cohort study to explore the impact of pretreatment emotional distress on survival and the predictive role of peripheral blood metabolic and inflammatory markers in immunotherapy response among treatment-naïve, advanced and inoperable Gastroesophageal Cancer (GEC) and non-small-cell lung cancer (NSCLC).

This is the prospective, observational cohort study to explore the impact of pretreatment emotional distress on survival and the predictive role of peripheral blood metabolic and inflammatory markers in immunotherapy response among treatment-naïve, advanced and inoperable Gastroesophageal Cancer (GEC) and Non-Small-Cell Lung Cancer (NSCLC). Eligible patients were administered first-line treatment with either immune checkpoint inhibitor or a combination of immunotherapy and chemotherapy upon enrollment. This study will have 2 cohorts:

* Cohort 1: A prospective, observational cohort study to explore the impact of pretreatment emotional distress on survival and the predictive role of peripheral blood metabolic and inflammatory markers in immunotherapy response among treatment-naïve, advanced and inoperable GEC patients.
* Cohort 2: A prospective, observational cohort study to explore the impact of pretreatment emotional distress on survival and the predictive role of peripheral blood metabolic and inflammatory markers in immunotherapy response among treatment-naïve, advanced and inoperable NSCLC patients.

Eligibility Criteria:
Cohort 1 \& 2

Inclusion Criteria:

* Meet the diagnostic criteria for cancer (including esophageal, gastric, GEJ or NSCLC) through clinical, pathological, and imaging examinations;
* Karnofsky Performance Status (KPS) score should be equal to or greater than 80 points;
* Unresectable locally advanced or metastatic;
* Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy);
* Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1);
* Receiving PD-1/PD-L1 inhibitors monotherapy or combination with chemotherapy;
* Informed and agreed to participate in the study;
* Required to complete the questionnaire independently or with assistance from others if needed;
* Legal age, 18 years or older.

Exclusion Criteria:

* Oncogene-driver positive;
* Combined with other malignant tumors in the past 3 years;
* Concurrent acute or chronic psychiatric disorders;
* Current receiving anti-depressive or anti-anxiety therapy or other psychotropic drugs;
* Previous treatment with other clinical drug trials;
* Patients with symptomatic brain metastasis;
* Severe intellectual disabilities or other communication difficulties that hindered normal interaction.