cyrilzakka/clinical-trials huggingface dataset:
Inflammation in Peritoneal Dialysis Patients: Effect of Obesity

Our study addresses the following research question: What is the role of obesity in modulating inflammation and innate immune function, as well as the overall responsiveness of innate immune cells (such as macrophages, neutrophils, and other peripheral leukocytes) in patients undergoing peritoneal dialysis?

The investigators hypothesize that obesity will lead to increased inflammation in patients undergoing peritoneal dialysis.

Chronic inflammation is highly prevalent in ESRD and associated with adverse outcomes. For example, chronic exposure of the peritoneal cavity to PD solution leads to induction of cytokines and other inflammatory mediators, generating peritoneal membrane inflammation which results in functional decline of ultrafiltration. Obesity is characterized by a state of chronic low-grade systemic inflammation stemming from expanded adipose tissue mass. Animal studies from our group and others suggest that obesity is associated with exacerbated prolonged inflammatory responses in the peritoneal cavity. The shifting demographic characteristics of the ESRD population, with a rise in elderly patients and those with obesity, is as a significant challenge for management of dialysis patients. Specifically, a 2-fold increase in the percentage of obese patients in the ESRD population has been reported. The caloric burden of PD glucose-containing solutions adds an additional risk for development or exacerbation of obesity and diabetes in patients using this dialysis modality. Few studies have directly evaluated the association between degree of adiposity and inflammation in PD patients. Data obtained from the proposed experiments will help clarify the connection between obesity and risk factors for cardiovascular and infectious diseases in the PD population. These data will also further our knowledge of the basic pathophysiology of both obesity and ESRD and enhance our understanding of factors involved in successful delivery of PD. Results may lead to enhanced nutritional recommendations for PD patients and/or the use of low-glucose or non-glucose alternatives, with a resultant reduction in local and/or systemic inflammation and CVD and other risk factors.

Eligibility Criteria:
Inclusion Criteria:

1. \> 18 years; and
2. peritoneal dialysis (PD) \> 6 months.

Exclusion Criteria:

1. infectious episode within 4 weeks; and
2. using immunosuppressive drugs
Dyspnea, Risk of Falling and Quality of Life in Adolescents, Youth and Geriatric Groups

To assess the correlation between aspects of the dyspnea scale (indicating poor functionality), the fall efficacy scale (indicating a higher fear of falling), and all aspects of the SF36 (indicating quality of life) in 3 age groups: adolescents, youth, and geriatrics.

An observational study was done to assess the correlation between aspects of the dyspnea scale (indicating poor functionality), the fall efficacy scale (indicating a higher fear of falling), and all aspects of the SF36 (indicating quality of life) in 3 age groups: adolescents, youth, and geriatrics. The participants in each group were assessed using the previously mentioned scales. Then the relationships between them were calculated and analyzed.

Eligibility Criteria:
Inclusion Criteria:

The participants were male or female community-dwellers, They ranged in age: adolescents from 12 to 17 years old, youth from 20 to 22 years old, and geriatrics from 60 to 80 years old.

Exclusion Criteria:

subjects with mobility disabilities and severe cognitive impairments.
Registry of the Combination of Antiplatelet Agents and Anticoagulant in Atrial Fibrillation Patients With a CHA2DS2VASc Score >1 Undergoing Percutaneous Coronary Interventions

Patients undergoing percutaneous coronary intervention (PCI) with stent implantation and requiring chronic anticoagulation for atrial fibrillation (AF) with a CHA2DS2-VASc \>1 are required to receive triple antithrombotic therapy . This triple therapy includes dual antiplatelet therapy with clopidogrel and aspirin in combination with an oral anticoagulant with either a vitamin K antagonist (VKA) or an oral anticoagulant (NOAC).

Recently NOAC, inhibiting the IIa (dabigatran) or Xa (rivaroxaban and apixaban) in the coagulation cascade have demonstrated non inferiority compared to VKA to prevent thrombo-embolic events in non-valvular AF for patients with a CHA2DS2-VASc \>1 . Interestingly, NOAC are associated with a reduced fatal bleeding rate compared to VKA. Overall they seem to result in a lower bleeding rate compared to VKA in association with antiplatelet agents.

Recently European guidelines regarding patients requiring chronic anticoagulant therapy and undergoing coronary stent implantation have been updated. However they are based on an expert consensus because of the scarce data available.

These guidelines advocate the combination of dual antiplatelet therapy with clopidogrel and aspirin in combination with the lower dose of OAC or VKA with a target INR between 2 and 2.5 . The triple therapy should be prescribed for 1 to 6 months depending on the bleeding and thrombotic risk and the clinical setting. In patients with high bleeding risk the guidelines suggest that a sole antiplatelet agent could be used in addition to anticoagulation following the WOEST study . In the recently published ESC guidelines on the management of atrial fibrillation, despite the lack of new data, the expert advocate triple therapy followed by dual antiplatelet therapy in most patients for 12 months.

The recently published PIONEER study reinforced the possibility of the use of rivaroxaban in these patients. In this trial including ACS and not ACS patients undergoing PCI rivaroxaban 15 mg in addition to a P2Y12 ADP receptor antagonist was associated with less clinically relevant bleeding compared to triple therapy with VKA- aspirin and clopidogrel and similar efficacy .


Eligibility Criteria:
Inclusion Criteria:

1. age over 18 years old
2. signed informed consent
3. requiring PCI (with stent placement) with subsequent need for antiplatelet therapy
4. FA requiring chronic anticoagulation (CHA2DS2-VASc \>1, except women with a score =1).

Exclusion Criteria:

1. pregnancy or lactation
2. age \<18 or not able to give an informed consent
3. no informed consent
4. no health insurance
5. prisoners
6. contra indication to antiplatelet therapy
7. intra cardiac thrombus
8. active bleeding Known bleeding diathesis (i.e. history of ICH, GI bleeding)
9. severe kidney failure (eGFR \< 30 mL/min/1.73 m²)
10. severe hepatic failure (Child-Pugh class B or C)
11. contra indication to OAC or VKA
12. hypertrophic myocardiopathy
13. valvular prosthesis
14. history of peptic ulcer
Interactive Exoskeleton Robot for Walking - Knee Joint

An exoskeleton robotic knee system for stroke rehabilitation is proposed in this study. This robotic system has been developed to facilitate functional motor recovery by practices walking with a one joint motor powered exoskeleton to reduce the muscle weakness in the shank and reduce the hyperextension in the knee joint. The robotic knee system is able to sense the gait pattern from the stroke patients and assist the walking and control the knee angle. The clinical trial will use repeated measurements to evaluate the effectiveness of the robotic knee system in gait rehabilitation post stroke.


Eligibility Criteria:
Inclusion Criteria:

1. Ischemic or hemorrphagic stroke with drop foot problem.
2. Sufficient cognition to follow simple instructions and to understand the content and purpose of the study. (Mini-Mental State Examination \> 20)
3. Capable of standing and walking independently for an extended period of time. (Functional Ambulation Category \> 3, Berg Balance Scale \> 40)

Exclusion Criteria:

1. Any medical or psychological dysfunctions that would affect their ability to comply with test study protocol, such as lower back pain, neuralgia, rotational vertigo, muscloskeletal disorders, injuries, and pregnancy.
2. Any severe contractures in hip, knee, or ankle joint that would preclude passive range of motion in the lower extremity.
3. Participation in any therapeutic treatment ("outside therapy") performed with the lower extremity during the planned study, including the baseline and the followup.
Evaluation of the Effect of HFMT in Promoting Donor-site Wound Healing

Autologous hair transplantation involves follicle extraction, trimming, and implantation. Follicle trimming improves efficiency and postoperative appearance, resulting in the discarded tissue known as hair follicle-derived microtissue (HFMT). In a clinical case, HFMT homogenate was applied to the FUE donor area wound, resulting in reduced pain, relief from itching, and faster healing compared to conventional treatment. This study aims to compare the effects of HFMT on FUE donor area wound healing.

The process of autologous hair transplantation involves three steps: FUE follicle extraction, follicle trimming, and follicle implantation. The purpose of follicle trimming is to improve the efficiency of follicle implantation and enhance the immediate postoperative aesthetic appearance. Therefore, during the follicle trimming process, the sebaceous glands and above-mentioned epidermis, partial dermis tissue, and surrounding tissue of the follicles are usually separated and discarded, and the remaining follicle tissue is implanted into the recipient area. The investigator collectively refers to the discarded tissue as hair follicle-derived microtissue (HFMT). In a clinical case, The investigator accidentally discovered that if the HFMT obtained from the follicular unit extraction (FUE) method was collected, cut into pieces, and made into tissue homogenate, and then the HFMT homogenate was used to cover the FUE donor area wound, the patient reported reduced postoperative pain and some relief from skin itching. Additionally, compared to conventionally treated wounds, the wound in the donor area healed faster. Based on these findings, this study aims to compare the effects of HFMT on the healing of FUE donor area wounds.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-60 years who underwent FUE autologous hair transplantation.
* The patient's liver and kidney function were normal, and the serum protein level before surgery was normal.

Exclusion Criteria:

* Patients with a history of smoking.
* Those suffering from diseases that affect wound healing, such as diabetes or hyperglycemia.
* Those with abnormal blood sugar.
* Abnormal cardiopulmonary function.
* There are foci of infection in or near the surgical area.
* Scar hyperplasia or scar constitution.
* Those with a history of neuralgia.
* The patient took immunosuppressants, cytostatics, and hormonal anticoagulants before surgery and antibiotics.
Cognitive Behavioral Therapy for Adolescents With Bulimia Nervosa and Higher Weight (Online Treatment Study)

This study will test the feasibility and acceptability of two treatments for adolescents with higher weight seeking treatment for bulimia nervosa (binge eating and purging, or going to extremes to lose weight).

This study will test the feasibility and acceptability of two treatments for adolescents with higher weight seeking treatment for bulimia nervosa. Bulimia nervosa is when individuals binge eat (overeat while feeling like they lost control) and purge (do something extreme or unhealthy to lose weight or prevent weight gain). Bulimia nervosa happens across different ages and body sizes. This study is focusing on adolescents who have a larger body size. Adolescents will receive treatment that is 4 months of 45-minute sessions, weekly. Treatment will occur over telehealth (e.g., zoom), and the whole study is online.

Eligibility Criteria:
Inclusion Criteria:

* Have higher weight (\>85th BMI percentile or \>85th percentile in past year)
* 2 binge/purge episodes per month for the prior 3 months
* Be otherwise-healthy youth (i.e., no uncontrolled or serious medical conditions);
* Read, comprehend, and write English at a sufficient level to complete study-related materials;
* Provide an approval form from a healthcare provider;
* Provide a signed and dated written assent (or consent for youth age 18 or 19) prior to study participation;
* Provide a signed and dated written consent from one parent prior to study participation;
* Be available for participation in the study for 4 months.

Exclusion Criteria:

* Medical or psychiatric conditions requiring hospitalization or intensive care
* anorexia nervosa
* developmental or cognitive disorders that would interfere with therapy
* pregnancy or breastfeeding
* concurrent treatments (medication or psychological) influencing appetite or weight
* began hormone therapy in prior 3 months
Remission Induction of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome

Biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome induced by ursodeoxycholic acid only or combination therapy of immunosuppressive agents


Eligibility Criteria:
Inclusion Criteria:

* 1.Patients aged 18-70 years;
* 2.Diagnosed with primary biliary cholangitis-autoimmune hepatitis overlap syndrome according to Paris criteria, based on liver biopsy results obtained 3 months before screening;
* 3.White blood cell count ≥2.5x10\^9/L or platelet count ≥50x10\^9/L at inclusion;
* 4.Agreed to participate in the trial, and assigned informed consent.

Exclusion Criteria:

* 1. The presence of hepatitis A, B, C, D, or E virus infection;
* 2. Patients with indications for immunosuppressive treatment at inclusion: serum alanine transaminase(ALT) or aspartate transaminase(AST) ≥10 fold upper limit of normal(ULN)，or serum ALT or AST≥ 5 fold ULN and γglobulin level ≥ 2 fold ULN, or bridging necrosis or multiacinar necrosis on histological examination.
* 3. Patients with complications of cirrhosis;
* 4. Patients with previous treatment of immunosuppressive agents or traditional Chinese medicine for more than one month;
* 5. Primary sclerosing cholangitis,non-alcoholic steatohepatitis,drug induced liver disease or Wilson's disease confirmed by liver biopsy;
* 6. Pregnant and breeding women;
* 7. Severe disorders of other vital organs, such as severe heart failure, cancer;
* 8. Parenteral administration of blood or blood products within 6 months before screening;
* 9. Recent treatment with drugs having known liver toxicity;
* 10.Taken part in other clinic trials within 6 months before screening.
Diabetes Risk Reduction Through Eat, Walk, Sleep and Medication Therapy Management for Depressed Cambodians

The primary aim of the study is to compare the effect of three different interventions on lifestyle risk factors and biological risk factors for type 2 diabetes in depressed Cambodians. The three different interventions are lifestyle, lifestyle plus medication therapy management, and social services.

Cambodian Americans have high risk for major depressive disorder and for type 2 diabetes. Depression is a known risk factor for diabetes. Some antidepressants can also increase risk of diabetes by causing weight gain. DREAM will test the effect of lifestyle and medication therapy management (MTM) compared to social services (control) on diabetes risk among depressed Cambodian Americans. Community health workers (CHWs) will deliver the lifestyle intervention and assist pharmacists with MTM. Lifestyle and biological risk factors for diabetes, such as depressive symptoms, HbA1c and insulin sensitivity, will be measured before and after the interventions.

Eligibility Criteria:
Inclusion Criteria:

* Self-identified as Cambodian or Cambodian-American
* Khmer speaking
* Likely major depressive disorder
* Elevated diabetes risk score per ADA guidelines
* Ambulatory
* Competent to give consent.

Exclusion Criteria:

* Pregnancy or plans to become pregnant in the next 2 years
* Previous diagnosis of diabetes
* Seeing or hearing problems that would interfere with group sessions
* Currently being followed by a physician for major medical problem
* Serious thinking or memory problems (e.g., schizophrenia or dementia)
* 3 or more days in a psychiatric hospital or self-harm in the past 2 years.
Evaluation of the Archimedes™ System for Transparenchymal Nodule Access

The Archimedes System is an image-guided navigation system used to access tissue samples in the lungs. This study is being conducted to confirm the performance of the Archimedes System in patients who are scheduled for standard bronchoscopy to diagnose highly suspicious lung cancer or metastatic disease. Navigation to and sampling of the patient's lung cancer tumor is conducted.


Eligibility Criteria:
Inclusion Criteria:

1. Age 21-75 years at screening
2. Highly suspicious SPN, defined as distinct nodule with a diameter of ≥8mm in its largest dimension
3. No known endobronchial tumor
4. Tumor located anywhere in parenchymal tissue \>1 cm from pleura and accessible bronchoscopically through a POE.
5. Willing to participate in all aspects of study protocol for duration of study
6. Able to understand study requirements
7. Signs study-related informed consent document

Exclusion Criteria:

1. Any contraindication to bronchoscopy, for example:

   * Untreatable life-threatening arrhythmias
   * Inability to adequately oxygenate the patient during the procedure
   * Acute respiratory failure with hypercapnia (unless the patient is intubated and ventilated)
   * Recent myocardial infarction
   * Previously diagnosed high-grade tracheal obstruction
   * Uncorrectable coagulopathy
2. Known coagulopathy
3. Platelet dysfunction or platelet count \< 100 x 103 cells/mm3
4. History of major bleeding with bronchoscopy
5. Suspected pulmonary hypertension: additional testing required, such as echocardiogram
6. Moderate-to-severe pulmonary fibrosis
7. Severe emphysema or COPD: additional testing and PI consent is required
8. Bullae \>5 cm located in vicinity of target SPN
9. Any other severe or life-threatening comorbidity that could increase the risk of bronchoscopic biopsy or ATV tunneling, for example:

   * ASA class \> 3
   * \> stage 3 heart failure
   * severe cachexia
   * severe respiratory insufficiency or hypoxia
10. Ongoing systemic infection
11. Contraindication to general anesthesia
12. Inability to stop anticoagulants (e.g., heparin, Warfarin) or antiplatelet agents (e.g. aspirin, clopidogrel) prior to procedure
13. Participation in any other study in last 30 days
14. Prior thoracic surgery on the same side of the lung as the SPN.
15. Breastfeeding women or females of childbearing potential with a positive pregnancy test prior to the procedure or the intent to become pregnant during the study.
16. Life expectancy of less than one year.
17. Scheduled for lung surgery within 72hrs post-scheduled diagnostic bronchoscopy
18. Pregnancy
Efficacy and Safety of Tislelizumab for Lung Adenocarcinoma With Asymptomatic Brain Metastatic

Brain metastasis of lung cancer is one of the most important metastasis pathways in patients with life-threatening diseases. This study explore the efficacy and safety of Tislelizumab combining with platinum-containing drug chemotherapy in the first-line treatment of Lung Adenocarcinoma With Asymptomatic Brain Metastatic. Meanwhile, Related biomarkers were explored to provide theoretical basis for efficacy evaluation and resistance mechanism.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with metastatic (stage IV) lung adenocarcinoma who have not been systematically treated and are histologically or cytologically confirmed as unable to undergo radical surgery or radiotherapy based on AJCC Stage VIII;
2. Patients with brain metastases confirmed by imaging;
3. Patients with asymptomatic BMS after initial diagnosis, local BMS surgery or radiotherapy;
4. ECOG PS: 0-1;
5. Measurable target lesions outside the skull (as per RECIST 1.1);
6. Life expectancy greater than 3 months;

Exclusion Criteria:

1. Patients had been treated with immune checkpoint inhibitors such as anti-PD-1, PD-L1, or CTLA-4 therapy;
2. The patient had received systemic chemotherapy as advanced treatment;
3. Patients with EGFR mutation or ALK gene translocation;
4. The patient had received approved systemic anticancer therapy or systemic immunomodulators (including but not limited to interferon, interleukin 2, and tumor necrosis factor) within 4 weeks prior to initial administration;
5. Clinically uncontrolled pleural fluid or ascites requiring puncture drainage within 2 weeks prior to initial administration;
Vitamine D in Post-COVID Patients

In this study routineously collected vitamine D values will compared to healthy cohorts from this year and previous years.


Eligibility Criteria:
Inclusion Criteria:

* patients with or without post-COVID-Syndrome

Exclusion Criteria:

* substitution of vitamine D
* diseases influencing vitamine D level
Clinical Trial to Assess the Efficacy and Safety of YYC405 in Type 2 Diabetes Patients

Phase 3 study to assess the Efficacy and Safety of YYC405 in Type 2 Diabetes Patients

Phase 3 study to assess the Efficacy and Safety of YYC405-T when added to Metformin and Dapagliflozin combination therapy in patients with type 2 diabetes mellitus who have inadequate glycemic control

Eligibility Criteria:
Inclusion Criteria:

* Patient who contsent to participate in this tiral by written informed consent form
* A man or woman over 20 years old
* Type 2 Diabetes patients

Exclusion Criteria:

* Patients with severe renal impairment, end-stage renal disease or on dialysis
* Type 1 diabetes patients
* Patients with a history of acute or chronic target acidosis, including lactic acidosis and diabetic ketoacidosis
Mindful Eating and Current Glycemic Control in Patients With Type 2 Diabetes

The goal of this observational study is to learn about the association of the level of mindful eating with the current glycemic control in patients with type 2 diabetes. The researchers will compare different glycemic control levels with the participants mindfulness while eating. And secondly, the researchers will compare the levels of eating awareness of those with and without obesity.

In type 2 diabetes, life style adaptations, mainly healthy eating, weight loss or control and exercise constitutes the foundation of type 2 diabetes management. In addition to regulating blood sugar levels, lifestyle modifications play a significant role in controlling risk factors such as hypertension and hyperlipidemia, delaying/preventing complications from developing, and even promoting diabetes regression. It is essential not only to focus on healthy food choices in dietary therapy but also to ensure patients achieve weight loss. Another crucial point is maintaining the continuity of these lifestyle changes.

It is reported that it is quite challenging for patients to make lifestyle changes, adapt to the offered treatments, and furthermore, sustain this as a way of life. Adherence to these dietary changes is crucial for long-term success in managing diabetes and achieving weight loss goals.

In a cross-sectional study conducted by Fanning and colleagues with 148 type 2 diabetic patients, it was found that "conscious eating" is associated with better diet adherence. In a review by Dunn et al., the available data strongly support the necessity of "conscious eating" as part of weight management programs. An American Heart Association statement highlights strong evidence that irregular eating patterns can make it difficult to maintain a healthy cardiometabolic profile, and emphasizes that conscious attention to mealtime and frequency can contribute to a healthier lifestyle and better management of cardiometabolic risk factors.

In this study, the aim was to investigate the degree of eating mindfulness of patients with type 2 diabetes, and compare it between patients who had good glycemic control and patients with poorly controlled glycemic.

Eligibility Criteria:
Inclusion Criteria:

* given consent to the study
* having applied to Diabetes Outpatient Clinic for diabetes management
* having diagnosed with type 2 diabetes for at least 6 months
* having the mental competence to answer the questions in the questionnaire

Exclusion Criteria:

* Inconclusive diagnosis of type 2 diabetes
* having not received or not using any treatment for diabetes