cyrilzakka/clinical-trials huggingface dataset:
Study of S-1 Plus DC-CIK for Patients With Advanced Gastric Cancer

The purpose of this study is to evaluate the antitumor effect and safety of clinical effectiveness dendritic cell activated Cytokine induced killer treatment (DC-CIK) plus S-1 based chemotherapy for advanced gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically/cytologically confirmed recurrent or metastatic gastric or esophagogastric junctional adenocarcinoma
* Between 18 and 80 years old
* Capable of oral intake
* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
* Karnofsky Performance Status (KPS) ≥ 70%
* Normal functions of heart, lung and bone marrow
* Adequate hematological profile： Hemoglobin ≥ 9.0 g/dL Absolute granulocyte count ≥ 1,500/mm3 Platelet count ≥ 100,000/mm3
* Adequate hepatic function Total bilirubin level≤ 3.0 times the upper limit of normal (ULN) Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN
* Adequate renal function(normal serum creatinine level)
* A life expectancy≥ 2 months
* Informed consent signed

Exclusion Criteria:

* Current enrollment in another clinical study with an investigational agent. Patients participating in surveys or observational studies are eligible to participate in this study
* Any radiotherapy or surgery within the previous 4 weeks
* Symptomatic brain metastasis not controlled by corticosteroids
* Bone marrow metastasis
* Active infection
* Serious complications
* Receiving a concomitant treatment with drugs interacting with S-1. The following drugs are prohibited because there may be an interaction with S-1: phenytoin, potassium warfarin , flucytosine, cimetidine and folinic acid.
* Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy
* Ineligible for the study at the discretion of investigators
Adiponectin and Inflammatory Mediators in Mediastinal Adipose Tissues

Coronary artery disease (CAD), the most common type of heart disease, is caused by hardening of the arteries, or atherosclerosis that is an inflammatory process in which immune mechanisms interact with metabolic risk factors to initiate, propagate, and activate lesions in the arterial trees. Epidemiological studies have found that increased cardiovascular risks are associated with increased levels of inflammatory cytokines (eg, interleukin-6 \[IL-6\] and tumor necrosis factor-alpha\[TNF-alpha\]) or their hepatic product, C-reactive protein (CRP). Higher expression of interleukin-Ibeta(IL-1beta),IL-6, monocyte chemotactic protein-1 (MCP-1), and TNF-alpha were observed in epicardial adipose tissues in patients with CAD. These findings suggested that the pericoronary tissues could be a source of inflammatory mediators or act as paracrine that lead to vascular inflammation on CAD pathogenesis. However, adiponectin, a kind of adipocytokine, produced and secreted exclusively by adipose tissue, has been reported to have a variety of anti-inflammatory functions against atherosclerosis, resulting in risk reduction for incidence of CAD events. It remains unclear whether adiponectin and inflammatory mediators in mediastinal adipose tissue contribute to CAD. We therefore aim to analyze the expression of adiponectin and inflammatory mediators in mediastinal adipose tissue between patients with CAD and with valve diseases, and to correlate these parameters with clinical atherosclerotic risks, medications (statins or antiplatelet), and blood sugar.


Eligibility Criteria:
Inclusion Criteria:

* patient underwent CABG or valve surgery in our hospital will be included

Exclusion Criteria:

* liver disease
* dhronic renal insufficiency
* neoplastic diseases
* taking steroids
* congestive heart failure
Visuo-Vestibular VR-based Stimulation Effects on Balance and Gait in Stroke Survivors

This pilot study aims to evaluate the effect of a specfic Virtual-Reality-Based rehabilitation training in patients with stroke. A total of 38 patients with stroke (more than 6 months from the acute event), recruited from the services of the Fondazione Santa Lucia IRCCS in Rome, will be included in the present study. Participants will be randomized into two groups: a Real group and a Sham group. Both groups will undergo a rehabilitation intervention using an immersive virtual reality system. The Real group will be exposed to scenarios containing specific stimuli for the visuo-vestibular system, while the Sham group will be exposed to the same scenarios but without specific stimuli. All participants in both groups will undergo 12 treatment sessions (three times a week), each lasting 20 minutes. All treatments will be conducted by physiotherapists specialized in neurological and vestibular rehabilitation. Patients will be assessed before the start of the treatment, at the end of the intervention, and one month after its completion, in order to evaluate the effects of the experimental training on balance and gait, and on the patient's perceived quality of life. Another aim will be to assess the user's satisfaction with the new proposed protocol.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a history of hemorrhagic or ischemic stroke (more than 6 months from the acute event)
* Patients aged between 18 and 80 years
* Absence of cognitive deficits that may interfere with the patient's ability to understand the exercise instructions (MiniMentalState Evaluation \> 24)
* Functional Ambulation Category ≥ 3
* Absence of associated orthopedic, visual, and/or neurological issues (clinically assessed) that may affect participation in the study

Exclusion Criteria:

* Patients with stroke (less than 6 months from the acute event);
* Patients aged under 18 and over 80;
* Presence of associated orthopedic, visual, and/or neurological issues (clinically assessed) that may affect participation in the study;
* Presence of cognitive deficits that may interfere with the patient's ability to understand the exercise instructions (MiniMentalState Evaluation ≤ 24);
* Epilepsy.
Diversity in Patients With OAB

An overactive bladder (OAB) is a condition characterized by frequent en nightly voiding, small bladder capacity and the occurrence of sudden urge to void, with or without urinary incontinence. The prevalence of OAB with bothersome complaints is around 11% in women and 9% in men with an increasing incidence with age. OAB is not an illness or disease but nevertheless had a significant impact on both the individual as society. First-line treatment for OAB consists out of behavioral and physiotherapy. Anticholinergic medication can be associated to improve bothersome symptoms, but has the downside of causing unwanted side effects. If the formentioned treatment is not sufficient, second line treatment can be discussed. Depending on the patient's characteristics and the physician's preference intravesical injections of Botox or the implantation of a sacral neuromodulator (SNM) can be considered.

Both options are equal and effective, but many individual differences exist in preference. Regarding outcome, some factors have been described to prefer one therapy above the other, for example in case of concomitant fecal incontinence, frequent urinary tract infections,... The personal preference of doctors and patients has been investigated, but currently no study has focused on therapy preference in a culturally and linguistic divers (CALD) population. The latter broadly describes a population with ethnical, cultural, religious and/or language characteristics and is a general accepted measure of diversity.

In the current study, the investigators aim to describe the different (dis)advantages of both second line treatments for OAB in a discrete choice experiment. The study population will consist of a diverse group of patients with OAB from different hospitals. The goal is to investigate if CALD patients make a different choice in treatment and what factors contribute to that decision in order to provide more tailored information regarding the treatment options in the future. Taking a patient's context into account in the shared decision making between a patient and physician increases therapy compliance and satisfaction of the chosen treatment.

The total questionnaire will consist out of general demographic info, the EQ-5D, the International Consultation on Incontinence Questionnaire (ICIQ)-OAB and the discrete choice questionnaire in which patients make a choice between two fictional treatment options consisting of a combination of different therapy characteristics. The questionnaire will be translated into different languages in order to lower the threshold for participation.


Eligibility Criteria:
Inclusion Criteria:

* OAB
* Adult

Exclusion Criteria:

* SNM or Botox in history
Management Strategy for Mild to Moderate Major Depression: Combination of Rhodiola and Saffron Extracts.

The purpose of the study is to describe, over 6 weeks, the evolution of depressive symptoms in patients with mild to moderate major depression in a strategy with Phytostandard® Rhodiola-Saffron supplementation

For this study, 52 patients are going to be included. They will have a supplementation of Phytostandard® rhodiola/saffron, from 2 tablets per day during 42 days.

on the one hand, during the two visits (inclusion and follow-up), the investigator completes the Hamilton Depression Scale (HAM-D) and the Clinical Global Impression (CGI). During the inclusion visit, he completes with his patient CIM-10 for depression diagnostic.

on the other hand, patients complete HAD 4 times : just after the inclusion visit, at day 14, at day 28 and just before the follow-up visit. He completes the Patient Global Impression too at each time.

Eligibility Criteria:
Inclusion Criteria:

* Suffering from mild to moderate depression as defined in CIM-10
* Having a score on the HAM-D questionnaire between 8 and 18
* Having agreed to participate at the study after being informed by the investigator

Exclusion Criteria:

* Depressive patients already under medication or discontinuation of medication less than a month ago
* Patients with severe depression as defined in CIM-10 or HAM-D\> 18
* Patients considered at risk: attempted suicide or suicidal (observed by the investigator or Hamilton item 3 score\> 2)
* Patients with psychiatric disorders: schizophrenia, bipolarity, addiction (drugs, alcohol ...), etc.
* Patient with severe disease (cancer, kidney or heart disease) or patient with a contra-indication for taking the product (patient under anti-hypertensive ...)
* Patients using agents containing piperine or St. John's wort (interactions)
* Pregnant or breastfeeding patients
* Patients who do not wish to complement Phytostandard® Rhodiola - Saffron.
* Patients who do not wish to participate in the study.
* Patients unable to understand the ins and outs of the study (mental incapacity, language barrier).
Non Small Cell Lung Cancer Patients Treated With Erlotinib Six Months or Longer

With roughly 80% of cancer patients receiving their oncology care in the community setting, the investigators are proposing to sample from a community-based center to evaluate the percentage of epidermal growth factor receptor (EGFR)-wild type patients that gain benefit from erlotinib and assess the clinical characteristics that are associated with erlotinib-responders. Additionally, biopsy specimens from enrolled patient cases that are EGFR-wt will be evaluated via exploratory genetic analysis for correlated markers.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have had NSCLC.
* Patients must have received erlotinib (single-agent) for six months or longer for NSCLC in the second/third line setting or as maintenance therapy.
* Patients must have tissue available for EGFR-mutation status testing (if not previously performed) or EGFR-mutation status test results available.
* Patients must have tissue available for exploratory genetic analysis.
* Patients must have all clinical information, treatment response data and outcomes data available for review.
* Patients must be deceased.
Effects of Beet Juice and Diet in Female Rowers

The purpose of this study is to determine the effects of nitrate-rich beetroot juice supplementation on exercise performance in female rowers when accounting for habitual vegetable nitrate consumption.

The objective is to use a stratified block randomization, double-blind crossover trial to test rowing ergometer exercise performance after drinking a beetroot juice supplement and compare it to the same test after consuming a placebo (a nitrate-free version of the beetroot juice supplement) in a convenience sample of athletes from a single Division 1-A collegiate women's rowing team.

Before testing, the participants' habitual vegetable nitrate consumption will be assessed from their report of foods consumed in the past 24 hours. Estimates of dietary nitrate intake will be calculated from the quantity of vegetables consumed and used to determine whether dietary nitrate intake influences the efficacy of the beetroot juice supplement.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Athletes currently on the university's rowing team

Exclusion Criteria:

* Injuries or medical conditions that prevent participation in their team's rowing training program
* Diagnosis of stage 2 iron deficiency
* Unable to consume beet juice for any reason
Project Connect Online: An Internet-based Intervention for Women With Breast Cancer

This randomized comparative effectiveness trial examines the potential psychosocial and physical health-related benefits of sharing personal websites with other women with breast cancer, as well as with family and friends (PCO PLUS condition) versus sharing with family and friends only (PCO condition) in a sample of women with metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* women at least 18 years of age;
* first diagnosis of Stage IV breast cancer or a recurrent diagnosis of metastatic breast cancer, any interval since diagnosis;
* ability to complete the intervention and assessments in English; and
* willingness to attend in-person PCO workshop;

Exclusion Criteria:

* male (because men constitute less than 1% of breast cancer patients, numbers would not be sufficient for reliable analyses);
* local (i.e., same breast, surgical scar, chest wall) or regional (i.e., lymph nodes) recurrent disease; and
* use of a personal website to post cancer-relevant material in the past six months
Laparoscopic Clip-Gastroplasty With The Use Of Bariclip

Sleeve gastrectomy, the most commonly performed bariatric surgery procedure, carries limitations both short-term including postoperative complications such as hemorrhage and gastric fistula and long-term such as weight regain and gastro-esophageal reflux. A new procedure has been proposed to overcome many of these limitations: laparoscopic vertical clip gastroplasty (LVCG) with Bariclip. Primary outcome were major postoperative complications. Secondary outcomes included weight loss, incidence of de-novo GERD and comorbidity resolution.

Methods. The investigators performed a review of data from a prospectively collected database. All patients submitted to primary LVCG were examined. Patients were submitted to LVCG Between July 2021 and March 2022. Collected data included demographic factors, pre-operative weight, pre-operative BMI, operative time, surgical complications, and clinical outcomes in terms of short and mid-term weight loss.

Eligibility Criteria:
Inclusion Criteria:

BMI \> 40 BMI \> 35 and comorbidities BMI \> 30 with poorly controlled Diabetes mellitus II or hypertension

Exclusion Criteria:

Alcoholism Drug addiction Psychiatric Disease
Reducing the Weight of Overweight Schizophrenia Patients

This study will determine the effectiveness of a group-based behavioral program for weight reduction in overweight and obese schizophrenia patients.

Researchers have found a link between schizophrenia, high blood pressure, and insulin resistance; this link puts people with schizophrenia at an increased risk for diabetes and obesity. Weight reduction and maintenance is essential for decreasing these risks. Although data indicate that nonpharmacological interventions for weight loss are viable options, studies to determine their effectiveness have not been conducted. This study will determine the effectiveness of behavioral training for reducing weight in schizophrenia patients. This study will also determine the effects of weight reduction on cardiovascular risk factors in this population.

This study comprises two phases. In Phase 1, participants will be randomly assigned to receive either behavioral training or social skills training for 14 weeks. The behavioral training will teach participants ways to control their diet and increase their physical activity. The social skills training will teach participants how to indirectly control their weight by making social contacts and seeking social support. After 14 weeks, participants in the social skills training group and any participants who have not lost a specified amount of weight will complete the study; participants in the behavioral training group who have a 4% or more weight loss will be enrolled in Phase 2, a 24-month program designed to help participants maintain their weight loss. All participants in Phase 2 will continue to receive weekly behavioral training, but they will be randomly assigned to receive either behavioral training alone or behavioral training combined with biweekly booster treatments where participants discuss their response to different diet and exercise regimens and researchers discuss strategies for increasing one's success with the regimens. Interviews, self-report scales, and blood tests will be used to assess participants at study entry, after Phase 1, and at the end of the study. Assessments will include quality of life, self esteem, exercise frequency, blood pressure, serum lipids, and blood glucose.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia or schizoaffective disorder
* Body mass index (BMI) greater than 27
* Stable on antipsychotic drug regimen for at least 1 month prior to study entry
* Parent or guardian willing to provide informed consent, if applicable
* Positive and negative syndrome scale score less than 90
* Willing to use acceptable methods of contraception during the study

Exclusion Criteria:

* Medical contraindication for participating in a weight reduction/exercise program
* Mental retardation
* Current enrollment in another weight management program
* Current use of weight reduction medication
* Unstable cardiovascular or thyroid disease
* Active or end-stage renal disease
* Psychiatric hospitalization within 1 month prior to study entry
* Current use of more than one anti-psychotic medication
* Pregnancy or breastfeeding
Efficacy of a Triclosan Formulation to Control the Initial Subgingival Biofilm Formation

The aim of the study is to compare the effect of a suspension containing Triclosan in dynamic of the subgingival biofilm formation versus a Placebo suspension. The initial subgingival biofilm formation will be evaluated by means of Plaque Free Zone (PFZ).

This is a double blind, cross over, randomized clinical trial. 28 volunteers will stop mechanical supragingiva biofilm removal measures for 96h following a complete scaling and polishing of the tooth surfaces. During this period they will be asked to rinse for one minute with a slurry of either a triclosan containing dentifice or a control without triclosan. Every 24h the presence of deposits will be registered with special atention to the presence of a plaque free zone between the apical border of the deposits and the gingival margin. Absence of deposits is scored 0, presence of deposits and plaque free zone =1 and presence of deposits and absence of plaque free zone =2 (MALISKA, A. N. et al. Measuring early plaque formation clinically. Oral health preventive dentistry, v. 4, p. 273-278, 2006). The prevalence of scores and the rate of changes from scores 0 and 1 into 2 will be evaluated for significance. Sample size was calculated taking the results from the study o MALISKA, AN (2006) as reference.

Eligibility Criteria:
Inclusion Criteria:

* age from 18 years;
* non-smokers;
* have good general health;
* present at least 20 natural teeth in the mouth, including the incisors, canines and premolars without restorations, crowns, gingival recession, anatomic defects, gingivitis e/or periodontitis.

Exclusion Criteria:

* positive history of using antibiotic e/or anti-inflammatory drugs in the month previous to the initial consultation;
* positive history of allergies at using Triclosan;
* pregnant or lactating patients;
* patients in use of fixed orthodontic appliance.
Sensorial Block Assessment of Erector Spinae Block

Ultrasound-guided erector spinae plane blocks are used as postoperative analgesia method for abdominal, chest and hip surgeries. Regional techniques are well-described methods for postoperative analgesia. However, the sensorial dermatomal spread of regional block varies depending on the multiple variables as the level of the block, local analgesic concentration etc. The aim of this study is to observe dermatomal evaluation of sensorial block.


Eligibility Criteria:
Inclusion Criteria:

* The patients who received successful erector spinae plane block for postoperative analgesia

Exclusion Criteria:

* Patients under 18 years old
* Patients who are not able to communicate with
* Patients who are on medication which may change the perception of pain.
A Study to Compare Tissue and Liquid Biopsies in People With Different Types of Cancer

In study, liquid biopsy samples will be obtained from non-small cell lung cancer (NSCLC) including Squamous cell carcinoma, Adenocarcinoma and large cell carcinoma, colorectal carcinoma (CRC) and pancreatic ductal adenocarcinoma (PDAC) patients who undergo treatment according to established standards of care (SoC) at the University Hospital Schleswig-Holstein (UKSH).

This study will observe the overall Variant Allele Frequency (VAF) of circulating tumour Desoxyribonucleic acid (ctDNA) levels over the patient therapeutic treatment course and will correlate these findings with tumour response as well as Kirsten rat sarcoma viral oncogene homolog (KRAS)mutation status.


Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old
2. Male or female patients with pancreatic ductal adenocarcinoma, colorectal carcinoma or adenocarcinoma of the lung as specified above leading to new treatment line.
3. Signed and dated written informed consent in accordance with International Council on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the study.
4. Willingness to undergo pre- and on-treatment liquid biopsies for biomarker assessment. Patients can be enrolled without tissue tumour biopsy upon agreement between the Investigator and the Sponsor.

Exclusion Criteria:

1. Patients not expected to comply with the protocol requirements or not expected to complete the study as scheduled (e.g. chronic alcohol or drug abuse or any other condition that, in the investigator's opinion, makes the patient an unreliable study participant).
2. Women who are pregnant or who plan to become pregnant during the study.
3. Participation at a clinical trial involving an investigational medicine where the treatment details cannot be disclosed.