cyrilzakka/clinical-trials huggingface dataset:
Preliminary Efficacy Analysis of 'λ+α' Double-Tract Reconstruction After Laparoscopic Proximal Gastrectomy

The incidence of proximal gastric cancer has increased significantly in recent years. This may be due to weight gain, alcohol consumption, gastroesophageal reflux disease (GERD), and precancerous lesions. With a deeper understanding of the pattern of lymph node metastasis and the emergence of anti-reflux procedures, proximal gastrectomy has gradually received clinical attention. For early-stage upper gastric cancer and esophagogastric combination cancer cases that are expected to have a good prognosis, the ideal surgical procedure should be to preserve the distal stomach to improve the quality of life and to choose a reasonable digestive tract reconstruction method to prevent reflux. The anti-reflux effect of various proximal gastrectomy digestive tract reconstruction methods and the advantages and disadvantages of various surgical procedures are controversial, and the recognized ideal reconstruction method has not yet been established. Therefore, based on the stomach's anatomical features and the intercalated jejunum's anti-reflux mechanism, we propose a true dual-channel anastomosis for GI reconstruction, i.e., the "λ+α dual-channel anastomosis". This study aimed to investigate the efficacy and safety of proximal gastrectomy combined with "λ+α double-channel anastomosis" in the treatment of early gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

Age between 18-75 years old, male or female; Pathological diagnosis of preoperative endoscopic biopsy: the tumor is located in the upper 1/3 of the stomach (including the esophagogastric junction), and the clinical staging of gastric cancer： Ia and Ib (T1N0M0, T1N1M0, and T2N0M0) (14) according to the eighth edition of the AJCC (15); No distant metastasis was observed on preoperative chest radiograph, abdominal ultrasound, or upper abdominal CT; ASA grade 1-3; Patients without contraindications to surgery; Patients and their families voluntarily signed the informed consent form and participated in the study;

Exclusion Criteria:

Patients diagnosed with primary tumors or distant metastasis; Patients whose tumor is located in the greater curvature side of the stomach; Patients with coagulation dysfunction that could not be corrected; Patients who were diagnosed with viral hepatitis and cirrhosis; Patients who were diagnosed with diabetes mellitus, uncontrolled or controlled with insulin; Patients with organ failure such as heart, lung, liver, brain, and kidney failure; Patients with ascites or cachexia preoperatively in poor general conditions; Patients diagnosed with immunodeficiency, immunosuppression, or autoimmune diseases (such as allogeneic bone marrow transplant, immunosuppressive drugs, SLE, etc.).

Patients refusing to sign the informed consent of the study;
A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis

This study will evaluate the effectiveness and safety of denosumab in treating women with Postmenopausal Osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

* Women who are 60 to 90 years of age may be eligible to participate
* Bone mineral density (BMD) T-Score at hip or spine must be less than -2.5

Exclusion Criteria:

* BMD T-Score at the hip or the spine of less than -4.0
* Patients with any severe or more than two moderate vertebral fractures on spinal x-ray at entry
Amputation Associated Factors and Prediction Model in Diabetic Foot Patients

Diabetic foot can lead to adverse consequences such as amputation and death, which seriously endangering the physical and mental health and quality of life for patients.

The aim of this study is to assess factors associated with the occurrence of amputation events in the diabetic foot patients based on a retrospective cohort and to construct a prediction model for patients at high amputated risk.

Diabetic foot is one of the major complications observed in patients with diabetes. Diabetic foot can lead to non-traumatic lower-limb amputation (LLA), and is confirmed to be associated with cognitive decline and worsening quality of life. Previous studies indicated that diabetics had a 25% lifetime risk of developing diabetic foot, and 14% to 24% of those require amputation. In patients with poor results of conservative treatment, amputation is the main terminal treatment option to avoid the spread of infection.

Amputation in diabetic foot patients may linked to different causes, including inflammatory, infectious and malignant conditions. A retrospective cohort based on Shandong Provincial Qianfoshan Hospital Healthcare Big Data Platform is conducted to evaluate the progression and prognosis of diabetic foot patients. A prediction model will be developed to identify high-risk diabetic foot patients of amputation and provide a scientific basis for personalized clinical care.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of diabetic foot
* Hospitalized patients
* No history of amputation

Exclusion Criteria:

* Patients with Bone Neoplasms
* Patients with osteomyelitis not caused by diabetes
* Patients with amputation caused by severe peripheral vascular disease not caused by diabetes
* Traumatic Amputations
* Patients in shock on admission
* Patients discharged against medical advice
Outcome After Non-invasive Ventilation.

The study is an exploratory retrospective observational study with the aim to describe outcome fo the cohort of patients that receive non-invasive ventilation at an intensive care unit.

Main research questions are:

* Characteristics of the cohort.
* The course for the patients at the ICU.
* ICU-mortality and 30-day mortality
* Amount of patients with limitations of care.
* Factors associated with mortality.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated with Non invasive ventilation
* Admitted to Sundsvalls ICU during 2018

Exclusion Criteria:

* Below 18 years age.
Study of Attentional Disorders in Patients Suffering From Idiopathic Generalized Epilepsy.

Attentional disorders have been reported in neuropsychological studies evaluating patients suffering from generalized idiopathic epilepsy, but the data are disparate (in terms of test protocol). We aim to describe attentional and executive function disorder in IGE thanks to the Epitrack scale, validated in this specific population. Our secondary objective is to study the dynamic of cortical activity during an attentional task (the ANT), in order to describe the alteration of cortical networks in epileptic patients presenting with attentional disturbance.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic generalized epilepsy followed-up during at least 2 years
* At least one antiepileptic drug medication
* No cognitive decline (MoCA score \>26)
* Absence of concomitant pathology that could interfere with the purpose of the study.
* Be affiliated to the social security system
* Have signed an informed consent

Exclusion Criteria:

* Pregnancy
* Not able to give consent (Article 1121-8 of the CSP) Vulnerable person Being deprived of liberty by judicial or administrative decision (Article L 1121-6 of the CSP) Have a high probability of not respecting the protocol or of abandoning the study
Transcutaneous Autonomic Modulation in Thoracic Surgery

In this study, the investigators aim to determine whether non-invasive autonomic modulation decreases inflammation and complications after thoracic surgery. The investigators will test the hypothesis that low-level transcutaneous vagal nerve stimulation (LLVNS) during major thoracic surgery reduces inflammation and complications, particularly postoperative atrial fibrillation (POAF). This will be a prospective randomized pilot trial of 200 patients undergoing major thoracic surgery including lobectomy, bilobectomy, or pneumonectomy via either video-assisted thoracoscopic (VAT) or open thoracotomy. Patients will be randomized to receive ether a) LLVNS (n=100) or b) sham LLVNS (n=100) during their procedure. All patients will receive standardized anesthetic, surgical, and post-surgical care. The primary outcome in this study will be time to occurrence of in-hospital POAF, which will be compared between groups using Cox proportional hazards models. Secondary outcomes will be ICU and hospital length of stay, postoperative morbidity, postoperative mortality, and serologic markers of inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Major thoracic surgery (lobectomy, bilobectomy, or pneumonectomy via either video-assisted thoracoscopic (VAT) or open thoracotomy)

Exclusion Criteria:

* Patients \>90 or \<40 years of age
* Chronic atrial fibrillation
* Prior splenectomy
* Preoperative inotropic support
* Hepatic or renal failure
* Currently receiving vagal nerve stimulation therapy
* Taking centrally-acting cholinergic medications (tacrine, donepezil, rivastigmine)
* High-grade atrioventricular block (\>2nd degree atrioventricular blockade)
Friendship Based HIV/STI (Sexually Transmitted Infections) Intervention for African American Females

The Project ÒRÉ intervention is a half-day community-based HIV/STI intervention program for friendship groups of adolescents that is tailored to African American culture. The four participating community sites will be assigned to either the Project ÒRÉ intervention or a standard health promotion program. Sexually experienced African American adolescent females will recruit members of their friendship group for the five-hour program. All participants will complete questionnaires before and immediately following the programs and another one 3 months later. Immediately following the program some of the Project ÒRÉ groups will also participate in a focus group to provide feedback about the program.

A group-randomized controlled design to test the efficacy of the Project ÒRÉ intervention, a community-based adolescent social network HIV/STI intervention tailored to African American culture. Four community based organization sites (CBOs) will be randomly assigned to an experimental or attention control condition. In both conditions, sexually experienced African American adolescent females will recruit members of their friendship group for the five-hour program. In the experimental condition, the intervention group will receive the half-day Project ÒRÉ intervention. The attention control group will receive a standard health promotion control program which has been used previously with similar populations. All participants will complete pre-, post- and 3-month follow-up self-administered questionnaires. In the experimental condition, a subset of groups will participate in a process evaluation focus group immediately following the program.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Between the ages of 14-18
* Self-identifies as African American
* Sexually experienced
* Willing to participate in a single five-hour workshop and a one-hour follow-up session
* Willing to nominate 2-5 close female friends ages 14-21 to participate in the study with her
* Lives in the experimental intervention community
* Ability to obtain permission from parent or legal guardian and assent from minors or consent from those above age of majority

Exclusion Criteria:

* Individual reports predominantly same gender sexual behavior
* Recent homelessness
* Visibly distraught or unstable (i.e. suicidal, manic, exhibiting violent behavior, etc.)
* Intoxicated or under the influence of psychoactive agents
Clinical Comparative Analysis of Bretschneider and St. Thomas Cardioplegia Solution in Case of Mitral Valve Repair Via Anterolateral Right Thoracotomy

Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy is done in cardioplegia with a cardioplegic solution, either HTK-Bretschneider (Custidiol®) (a crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular solution).

This study investigates HTK-Bretschneider versus St. Thomas cardioplegic solution regarding peri- and postoperative outcome, especially for cardiac biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy done in cardioplegia with a cardioplegic solution, either HTK-Bretschneider (Custidiol®) (a crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular solution).

Exclusion Criteria:

* Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy done in cardioplegia with cardioplegic Solutions other than HTK-Bretschneider (Custidiol®) (a crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular solution).
Study Evaluating the Efficacy and Safety of Fexofenadine in Subjects Suffering From Seasonal Allergic Rhinitis in Presence of Pollutants

Primary Objectives:

* To demonstrate that the aggravation of seasonal allergic rhinitis symptoms in the presence of pollutants is observed using an Environmental Exposure Unit.
* To evaluate the efficacy of fexofenadine hydrochloride in subjects suffering from seasonal allergic rhinitis symptoms aggravated in the presence of diesel exhaust particulates.

Secondary Objective:

To evaluate the safety of a single dose of fexofenadine hydrochloride 180 mg.

The total study duration per subject is expected to last up to 4.5 months, depending on the timing of the screening visit.

Eligibility Criteria:
Inclusion criteria:

* Males or females between the ages of 18 and 65 suffering from seasonal allergic rhinitis provoked by ragweed pollen.
* Having a 2-year history of seasonal allergic rhinitis with positive skin prick test to ragweed allergen at screening with a wheal diameter at least 3 mm larger than that produced by the negative control.
* Subjects with antecedents of allergic seasonal allergic rhinitis symptom aggravation when exposed to pollen and air pollutants (i.e., cleaning products, diesel, paints).
* Subjects having a total nasal symptom score ≥3 in Period 1 (Visit 2).

Exclusion criteria:

* History of anaphylaxis to ragweed pollen.
* History of asthma. Mild asthmatics treated only with pro re nata short-acting beta2-agonists, 2 doses or less per week can be enrolled.
* History of chronic sinusitis.
* History of systemic disease affecting the immune system.
* Evidence of any active or suspected bacterial, viral, fungal or parasitic infections within 30 days prior to allergen challenge.
* Any history of Grade 4 anaphylaxis due to any cause as defined by the Common Terminology Criteria for Adverse Event grading criteria ("Life threatening consequences: urgent intervention indicated").
* Presence or history of drug hypersensitivity to fexofenadine.
* Subjects receiving build-up injections of pollen allergen immunotherapy (those on stable maintenance dosing can be included).
* Subjects taking any forbidden treatments/nutriments.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Treadmill Training Effects on Cardiorespiratory Endurance and Constipation in Children With Cerebral Palsy

This study examines the impact of treadmill training on cardiorespiratory endurance and constipation in children with cerebral palsy (CP). Treadmill training is evaluated for its potential to improve cardiovascular fitness and alleviate constipation through its rhythmic movements. The findings shed light on the broader health benefits of treadmill interventions beyond motor function improvement in children with CP

This research investigates the effects of treadmill training on two distinct yet interconnected aspects of health in children with cerebral palsy (CP): cardiorespiratory endurance and constipation.

The research employs a longitudinal design, with participants undergoing a structured treadmill training program tailored to their individual needs and abilities. Outcome measures include objective assessments of cardiorespiratory fitness (e.g., exercise stress tests, spirometry) and subjective evaluations of constipation symptoms (e.g., bowel diaries, symptom questionnaires). Additionally, the study examines potential correlations between improvements in cardiorespiratory endurance and changes in constipation severity, exploring the interplay between physical fitness and gastrointestinal function in children with CP.

By investigating the effects of treadmill training on both cardiorespiratory endurance and constipation, this research aims to provide a comprehensive understanding of the broader health benefits associated with exercise interventions in children with cerebral palsy. The findings may inform the development of integrated rehabilitation programs that address multiple aspects of health and well-being in this population, ultimately improving overall quality of life and functional outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age 4 to 12 years.
* Children having 1, or 2 on GMFCM.
* Children with spastic diplegic cerebral palsy.
* Children with well cognitive behavior.
* Children having 1 to 2 level on constipation assessment scale.
* Defecation frequency less than 3 time a week.

Exclusion Criteria:

* Misdiagnosed or not conform to Cerebral palsy.
* Children should be medically stable uncontrolled seizures.
* The children with mental retardation or other neurological disorders.
* Children with taking medication like muscle relaxant or laxative
Study Evaluating the Long-Term Safety and Efficacy of ABX464 in Patients With Moderate to Severe Rheumatoid Arthritis

A phase 2a open-label study to evaluate the long-term safety and efficacy of ABX464 50mg as maintenance therapy in patients with moderate to severe rheumatoid arthritis.

This Phase 2a open-label study aims at investigating the long-term safety and efficacy of an oral dose of ABX464 in patients who have been previously enrolled in the ABX464-301 clinical study and who are willing to continue their treatment.

All patients will receive ABX464 given at 50mg o.d. irrespectively of their previous treatment received in the ABX464-301 study (i.e. ABX464 or Placebo).

The enrolment in this follow-up study will be based on the willingness of the subject to carry on his/her participation and also based on investigator's judgement.

Patients will be treated with ABX464 for a period of 52 weeks. If they achieve a clinical response on Week 52 (defined as DAS28-CRP ≤ 2,6 for anti-TNFα naïve patients or DAS-28-CRP ≤ 3,2 for patients previously treated by anti-TNFα), they will be eligible to continue treatment for up to 104 weeks.Patients will be followed up at week , week 2 and then, on a monthly basis the first year (up to W52), and quaterly the second year (up to W104).

Eligibility Criteria:
Inclusion Criteria:

* Patients previously enrolled in the ABX464-301 clinical study who have completed the initial 12 weeks of treatment period;

Criteria that should be met by patients at week 52 to be eligible for 52 additional weeks of study treatment:

▪ Patients should be in clinical response. Clinical response is defined as: DAS28-CRP ≤ 2,6 for anti-TNFα naïve patients or DAS-28-CRP ≤ 3,2 for patients previously treated by anti-TNFα.

Exclusion Criteria:

* Any condition, which in the opinion of the investigator, could compromise the patient's safety or adherence to the study protocol
Evaluation of Photodynamic Treatment FOTOSAN® Efficacy in Periodontology

Periodontitis are infectious and inflammatory diseases of gum and tooth supporting tissues leading to tooth loss and oral disability. Twenty to 30 percents of patients treated for periodontal diseases display more or less pronounced persistence of periodontal tissue infection, inflammation, and destruction. The therapeutic additional value of photodynamic anti-infectious treatment remains controversial. The objective of this study is to evaluate the mid-term effect of the photodynamic device Fotosan®630 on severe periodontitis treatment outcomes and to define its specific therapeutic indications.


Eligibility Criteria:
Inclusion Criteria:

* aged 40 years
* signed informed consent
* generalized severe chronic periodontitis
* patient with at least 24 teeth
* more than 30% of sites with clinical attachment loss \>5mm- at least 5 sites with pocket depth \>4mm per quadrant- at least one molar per quadrant- evidenced bone loss on radiographs- bleeding on probing ≥30%

Exclusion Criteria:

* aggressive periodontitis
* smoking more than 10cig/day
* patient with endocarditis risk or need of antibiotic prophylaxis
* pregnant women
* patient included in other trials
* patient under guardianship
* patient treated with antibiotics, anti-inflammatory, and other drugs (inhibitors of calcium channels...) influencing periodontal status within 6 months before examination
* patient suffering from diseases influencing periodontal status (diabetes...)
* patient periodontally treated with root planing or periodontal surgery within 1 year before examination
* patient with scheduled extensive prosthetic treatment
* patient with a high haemorrhagic risk (INR\>4)
* impossible patient cooperation
Pre-Surgical Trial of the Combination of Metformin and Atorvastatin in Newly Diagnosed Operable Breast Cancer

The purpose of this study is to determine the effects of combining metformin and atorvastatin treatment in patients with newly diagnosed breast cancer during the interval between breast biopsy and surgery.

This study is designed to assess whether tumor proliferation, as measured by the natural log expression of Ki-67 staining of breast tumor cells, is reduced following approximately 2 weeks of treatment with the combination of metformin plus atorvastatin in patients with newly diagnosed breast cancer.

Breast cancer cells require energy homeostasis shifts with enhanced anabolism to enable rapid growth and continued proliferation. The main energy regulatory system in eukaryotes and breast cancer cells is the AMP-activated kinase (AMPK) pathway. AMPK is triggered by changes in the AMP/Adenosine triphosphate (ATP) ratio thus impacting energy reserves and requirements. AMPK pathway closely interacts with the phosphoinositide 3-kinase (PI3K)/Akt signaling pathway, affecting the downstream function of the master regulator mammalian target of rapamycin (mTOR). Activation of AMPK has been shown in vitro to result in inhibition of proliferation of various cancer cell lines.

Utilizing a pre-surgical model, the investigator plans to conduct a pilot study of 40 women with newly diagnosed invasive breast cancer or ductal carcinoma in-situ (DCIS) who will receive oral metformin and atorvastatin daily in the interval between diagnostic breast biopsy and definitive breast surgery.

The goal is to determine if dual combination treatment with metformin plus atorvastatin significantly impacts tumor-based markers, such as proliferation, and blood-based biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects with histologically-confirmed operable invasive breast cancer or DCIS, who undergo core needle biopsy followed by surgical excision at least 2 weeks after enrollment
* ≥ 5 mm by imaging/pathology of core to ensure enough pre- and post-treatment tissue for analysis
* Age ≥ 21 years. Breast cancer is uncommon in patients less than this age.
* No prior chemotherapy, radiation therapy, or breast resection within 6 months of study entry
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
* Signed informed consent

Exclusion Criteria:

* Currently on medication for diabetes or hypercholesterolemia
* Treatment with other investigational drugs within 6 months of study entry
* Strong Cytochrome P450 3A4 (abbreviated CYP3A4) (e.g., clarithromycin, HIV protease inhibitors, and itraconazole), given potential interactions with atorvastatin
* Renal impairment with a creatinine \> 1.4 mg/dl
* Hepatic impairment: Aspartate transaminase (AST)/(SGOT), Alanine Transaminase(ALT)/(SGPT) ≥ 2.5 x upper limit of normal range (ULN), OR Total bilirubin ≥ 1.5 x ULN (subjects with Gilbert's syndrome can have bilirubin of up to 1.5 x ULN), OR Alkaline phosphatase \> 2.5 x ULN