cyrilzakka/clinical-trials huggingface dataset:
Immunotherapy Using Precision T Cells Specific to Personalized Neo-antigen for the Treatment of Advanced Malignant Tumor of Biliary Tract

Objectives:

The purpose of this study is to evaluate the safety and prognosis of dendritic cell-precision T cell for neo-antigen in the treatment of advanced biliary tract malignant tumor.

Methods:

This study designs a novel therapy using dendritic cell-precision multiple antigen T cells. 40 patients will be enrolled. They are randomly divided into gemcitabine group and dendritic cell-precision T cell for neo-antigen combined with gemcitabine group. Gemcitabine treatments will be performed once a week with a total of six times. Dendritic cell-precision T cell for neo-antigen combined with gemcitabine treatment: Gemcitabine: once a week with a total of six times before 60 days prior to the start of drawing blood. Dendritic cell-precision T cell for neo-antigen: once per 3 weeks with a total of three periods. The mail clinical indicators are Progression-Free-Survival and Overall Survival.

A total of 40 patients may be enrolled over a period of 1-2 years.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age 18\~65 years old, male or female;2. Life expectancy \> 6 months;3. Eastern Cooperative Oncology Group (ECOG) score: 0-2;4. Laboratory examination: ① white blood cell ≥ 3 x 109/L. blood platelet count ≥ 60 x 109/L; hemoglobin ≥85g/L; ② total bilirubin ≤100 mol/L; aminopherase less than five times of the normal; ③ serum creatinine less than 1.5 times of the normal;5. Signed informed consent;6. Patients with fertility are willing to use contraceptive method.

Exclusion Criteria:

* 1. Expected Overall survival \< 6 months;2.Other serious diseases:the heart,lung, kidney, digestive, nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, Etc.3.serum creatinine \> 2.5mg/dL; Serum Glutamic Oxaloacetic Transaminase (SGOT) \> 5 times of the normal;total bilirubin \> 100μmol/L; 4.Other drugs, biological, chemotherapy or radiation therapy were used within 1 months;5. Without signed Informed consent.
Targeting Cognitive Immunization in Depression

Research has shown that people suffering from MDD tend to maintain dysfunctional expectations despite experiences that disconfirm expectations. Recently, it has been shown that this persistence of expectations is due to maladaptive information processing involving "cognitive immunization". This experimental study aims at testing three different strategies to inhibit cognitive immunization, in order to enhance expectation change.

It appears adaptive to change one's expectations when continuously gaining expectation-disconfirming experiences; however, research has shown that people suffering from MDD have difficulty in changing their expectations after experiences that disconfirm expectations. Recently, the investigators have shown that this persistence of expectations is due to maladaptive information processing involving "cognitive immunization", defined as a cognitive reappraisal of expectation-disconfirming experiences in such a way that the individual's expectations are maintained. In view of psychotherapeutic interventions aiming to modify patients' dysfunctional expectations, effective strategies to inhibit cognitive immunization strategies need to be identified. Therefore, the aim of this study was to compare different immunization-inhibiting strategies with regard to their effectivity in enhancing expectation change. For this purpose, the investigators use a standardized experimental paradigm, which was developed and validated in a previous study.

Eligibility Criteria:
Inclusion Criteria:

* current diagnosis of Major Depressive Disorder
* at least 18 years old
* sufficient German language knowledge

Exclusion Criteria:

- none
Truncated and Extended Forms of Amyloid Beta Peptides in Alzheimer's Disease: Genesis, Toxicity and Identification as Biological Markers

Beta amyloid immunoreactivity is probably due to a significant number of Ab catabolites corresponding to N-terminally truncated and Cterminally truncated or extended forms which display distinct propensity to aggregation. Very few things are known concerning the mechanisms and proteases by which they are generated. Furthermore, the link between truncation and toxicity has not been delineated.

Finally, little is known concerning Ab fragments in biological fluids and whether they could be seen as early biomarkers and thereby, as putative targets for AD diagnostic. The present project will allow to examine the human biological samples and to identify various cohorts after complete clinical evaluation.


Eligibility Criteria:
Inclusion Criteria:

* 1) Coming subjects to see patients in CMRR for a complaint mnésique 2) Introducing a score in Tiny Mental the upper Test (MMSE) in 28/30 without error in under score of the recall of the 3 words 3) Introducing a score of 10/10 in the test of the 5 words of B2C 4) Introducing a score in the ladder CDR (Clinical Dementia Rating) equal to 0 5) Having given a lit consent 6) Being affiliated member or beneficiary of the regime of French national health and pensions organization

Exclusion Criteria:

* Major, all the vulnerable persons under 18 under tutelage, under legal guardianship, deprived of freedom, hospitalized in a health Establishment or social for quite other reason that searches it
* Record of neurological or psychiatric pathology and inability for sensory reasons to perform a cognitive balance sheet
Preoperative CHG Cloth on Healthy Subjects

Evaluate the effects of CHG cloth on the reduction of bacteria on the skin.

Examine the antimicrobial cloth effects on normal flora bacteria of the abdomen and groin area post CHG application.

Eligibility Criteria:
Inclusion Criteria:

* Males or Females
* 16 years of age or older
* Signed informed consent
* Good Health
* Six inches of abdomen and groin areas without tattoos, or skin disorders

Exclusion Criteria:

* Dermatological Conditions
* Sensitivity to latex
* Sensitivity to CHG
Biology of Osteosarcoma (BOOST) Registry and Biobank

Osteosarcoma is very rare cancer of the bone. The investigator started the BOOST registry and biobank to make sure every patient has the opportunity to participate in research.

Summary to include:

1. Samples of saliva, blood and/or other stored material such as slides or leftover diagnostic material. If available the investigator may ask you for deciduous (baby) teeth.
2. Questionnaire information, including health history, growth and development, physical activity and family medical history information.
3. If you have been diagnosed with a osteosarcoma or another condition the investigator is interested inthe investigator will ask you release medical record information relating to diagnosis and treatment of osteosarcoma, other cancers, blood disorders, and similar conditions. If this step applies to you then you will be asked to sign a separate form.
4. You may be asked to contact your biological parents and full biological siblings to ask them about participating in the study.
5. If you agree you may be contacted in the future. You will be able to decline any future information or studies at any point.

Eligibility Criteria:
Inclusion Criteria:

* Proband Inclusion criteria: A diagnosis or suspected diagnosis of osteosarcoma (ICCC 9180-9200)

Family member inclusion criteria: Biological parents and full biological siblings of a case diagnosed with osteosarcoma (ICCC 9180-9200)

Exclusion Criteria:

* Does not understand English.
Does ESP Block Reduce Pain and Opiates Consumption After Surgery

The patients will be randomly assigned to standard therapy or standard therapy+ESP nerve block. After surgery pain level and narcotic consumption will be measured, and vital signs and side effects will bo monitored for up to 72 hours. 6 months after surgery a phone interview will be conducted to asses chronic pain

patients will be divided randomly into two groups before the beginning of operation: Group 1: patients will be treated to standard pain control treatment ; Group 2: patients will receive Erector spinea block (30-40 mL Ropivacaine 0.375% plus 2 mg Dexamethasone injection using ultrasound approach) additionally to standard pain control treatment The ESB (erector spinae plane block) will be performed at the beginning of the procedure while the patient under general anesthesia, in assistance of ultrasound for visualization, anesthetic injection 30-40 mL Ropivacaine 0.375% plus 2 mg Dexamethasone administered on each side between thoracic transversus process and longitudinal spinea muscle. in the the postoperative care room, the vital sings and pain level will be continuously monitored.

During the postoperative period stay the pain level of each patient will be assessed by of Visual Analog Score of pain (VAS: 0-10) interviewing the patient every 30 minutes from the patient's admission from operation room and thereafter every 1 - 4 -8 -12 -24 -48 - 72 hours, at discharge, 7- 14-21 days.

For a more accurate assessment of pain, a pre-operative baseline level of pain eill be recorded.

Any postoperative pain will be routinely managed by 5-10 mg of intravenous morphine to achieve a VAS scale of none or mild pain (1-5). investigators will also continue to record events of postoperative nausea and vomiting (PONV) within 24 hours after procedure. The PONV will be assessed by the PONV Impact Scale score, based on numerical responses to questions. A PONV Impact Scale score of ≥5 defines clinically relevant PONV.

Recording of urinary retention, constipation, opioid requirements and itching will also be preformed.

After 3 and 6 months a telephone survey will be preformed - recording pain related to surgery and to asses chronic pain syndrome. During the phone conversation, patients will be asked to answer by the brief pain inventory.

Eligibility Criteria:
Inclusion Criteria:

1. All patients undergoing thoracic surgery, older ≥18 years
2. Patients who meet criteria of ASA (american society of anesthesiologists) physical status I-II-III class.

Exclusion Criteria:

1. Patients who will be unconscious or mentally incompetent
2. Patients refusal to participate in the study
3. ASA -IV -V
4. Patient with coagulopathy
5. Hemodynamically unstable (systolic blood pressure \< 90, heart rate (HR) \> 100)
6. Allergy to local anesthetic drugs or opioids
7. Pregnant patient
8. History of opioid abuse
Effects of Oral Iron Supplementation Before vs at Time of Vaccination on Immune Response in Iron Deficient Kenyan Women

Iron deficiency (ID) anemia (IDA) is a global public health problem, with the highest prevalence in Africa. Vaccines often underperform in low- and middle-income countries (LMIC), and undernutrition, including ID, likely plays a role. Recent studies have shown the importance of iron status in vaccine response. Intravenous iron given at time of vaccination improved response to yellow fever and COVID-19 vaccines in IDA Kenyan women. Whether oral iron treatment would have a similar beneficial effect on vaccine response is uncertain. Also, timing of oral iron treatment needs further investigation.

The co-primary objectives of this study are to assess 1) whether IDA in Kenyan women impairs vaccine response, and whether oral iron treatment improves their response; 2) the timing of oral iron treatment to improve vaccine response (prior to vaccination vs at time of vaccination).

We will conduct a double-blind randomized controlled trial in southern Kenya to assess the effects of iron supplementation on response to three single-shot vaccines: Johnson \& Johnson COVID- 19 (JJ COVID-19), the quadrivalent meningococcal vaccine (MenACWY) and the typhoid Vi polysaccharide vaccine (Typhim Vi). Women with IDA will be recruited and randomly assigned to three study groups: group 1 (pre- treatment) will receive 100 mg oral iron as ferrous sulfate (FeSO4) daily on days 1-56; group 2 (simultaneous treatment) will receive matching placebo daily on days 1-28, and 200 mg oral iron as FeSO4 daily on days 29-56; and group 3 (control) will receive matching placebo daily on days 1-56. Women in all groups will receive the JJ COVID-19 vaccine, the MenACWY and the Typhim Vi vaccine on day 28. Cellular immune response and serology will be measured at 28 days after vaccination in all groups.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give informed consent for participation in the trial
* Female aged 18-49 years
* Moderate anemia (Hb \<110 g/L, but not severely anemic with Hb \<80 g/L)
* Iron deficient (ZnPP \>40 mmol/mol haem)
* Anticipated residence in the study area for the study duration

Exclusion Criteria:

* Major chronic infecious disease (e.g., HIV infection);
* Major chronic non-infecious disease (e.g., Type 2 diabetes, cancer);
* Chronic medications;
* Use of iron-containing mineral and vitamin supplementation 2 weeks prior to study start;
* COVID-19 vaccine or confirmed COVID-19 infection within the past 2 years
* MenACWY vaccine in the past
* Typhim Vi vaccine in the past
* Pregnant (confirmed by rapid test during screening)
* Malaria (confirmed by rapid test) à study start will be postponed
VA Cultivating Access to Resources, Education, and Skills for Dementia Caregivers

The purpose of this study is to study the effects of an education and skill-building intervention on family caregivers of Veterans with dementia.

According to VA estimates, nearly 500,000 Veterans suffer from dementia. There is currently no cure for dementia. Ultimately, dementia will have a large impact on quality of life in Veterans and families, lead to expensive nursing home placement, and decrease life expectancy for patients and family caregivers. The experience of high burden in a caregiver for a Veteran with dementia increases the likelihood of permanent nursing home placement and can separate Veterans from their families. To address the high burden of caring for a Veteran with dementia, the investigators aim to study the effect of a rehabilitative intervention for family caregivers of Veterans with dementia. This novel approach will use video technology that can reach caregivers in rural areas who do not have easy access to major VA medical centers.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria -- Participants must:

* be adults (age 18)
* report distress associated with being the primary caregiver for a Veteran family member with all-cause dementia
* reporting at least 2 of the following 6 items at baseline assessment: felt overwhelmed, felt like they often needed to cry, were angry or frustrated, felt they were cut off from family or friends, reported moderate to high levels of general stress, or felt their health had declined
* provide at least one hour of care (supervision or direct assistance) per week over the past 3 months (other sources of caregiving for the Veteran with dementia can also be utilized; e.g., respite, home health aide, other family members, etc.)
* be proficient in spoken and written English
* be capable of providing informed consent

Exclusion Criteria:

Exclusion criteria -- Potential participants will be screened and excluded for:

* current or lifetime history of any psychiatric disorder with psychotic features
* prominent suicidal or homicidal ideation
* having met DSM-IV criteria for drug or alcohol abuse or dependence (except nicotine) within the past six months
* presence of alcohol intoxication (by breathalyzer) or alcohol withdrawal (by exam) during study recruitment or participation
* diagnosis of probable or possible dementia
* a Telephone Cognitive Screen score of \< 20
* participation in another caregiver intervention within the past year
* lack of regular access to a telephone
* illness that would prevent 24 months of study participation
* planned transfer of care receiver to another caregiver or nursing home within 12 months
Nutritional Modulation of Cognition and Brain Activity

The aim of the present study is to investigate the effects of different meal interventions on cognition (i.e., learning and decision making) and brain activity in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 40 years old
* fluent in German
* right-handed
* able to safely undergo MRI scanning
* BMI (Body-Mass-Index) between 18.5 and 29.9 kg/m2

Exclusion Criteria:

* current medication that might interfere with the processes studied
* any metabolic, gastrointestinal, cardiological, neurological, psychiatric or any recurring or chronic diagnoses
* drug use
* alcohol consumption \> 10 g/d for women and \> 20 g/d for men
* smoking
* shifted circadian rhythm (e.g. jetlag, shift work)
* vegan or vegetarian diet
* food intolerances
* females: hormonal contraception, pregnancy, lactation
Comparison of Transcutaneous Auricular Vagus and Trigeminal Nerve Stimulation

The aim of this study was to compare the results between transcutaneous auricular vagus nerve stimulation and trigeminal nerve stimulation with the results obtained from heart rate variability, pulse and blood pressure measurements and to reveal which method is more effective in autonomic nervous system neuromodulation.

Hypotheses of the study:

H0: Vagus nerve stimulation is more effective than trigeminal nerve simulation in terms of heart rate variability.

H1: Trigeminal nerve stimulation is more effective than vagus nerve simulation in terms of heart rate variability.

In this study, 80 healthy participants (40 males, 40 females) aged between 20-50 years were randomized (www.randomizer.org) into four groups by computer software. After randomisation, one group was received transcutaneous vagus nerve stimulation inside the ear, while the other group was received trigeminal nerve stimulation above the ear.The third group received sham transcutaneous vagus nerve stimulation and the fourth group received sham trigeminal nerve simulation. Heart rate variability, pulse rate and blood pressure measurements were performed to determine which stimulation method is more effective. Heart rate variability was analysed with Kubios HRV programme after the 5-minute short measurement method. SNS, PNS and Stress Index and LF, HF and LF/HF parameters were evaluated in heart rate variability sub-parameters.

Eligibility Criteria:
Inclusion Criteria:

* To be 18 years of age or older,
* Not having any acute or chronic disease.

Exclusion Criteria:

* Having any acute or chronic disease,
* Having previously undergone vagus nerve stimulation or trigeminal nerve stimulation.
Effects of Breathing Exercises on Reaction Time

The aim of the study was to investigate the short and long-term effects of breathing exercises on reaction time.

A total of 40 participants who volunteered to participate in the study from the students of the Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Bandırma Onyedi Eylül University will be included in the study. Participants will be randomly divided into two groups using a simple random numbers table. The study group (15 people) will be given respiratory exercises (12 sessions). The control group (15 people) will receive no intervention. In the study, after the demographic characteristics of the participants are obtained, reaction time will be evaluated with auditory and visual reaction tests and upper extremity reaction tests. All evaluations are planned to take a total of 15 minutes.

The same assessments will be performed in both groups. To measure the long-term effect, after the initial evaluations are completed, the study group will be given a total of 12 sessions of breathing exercises for 4 weeks (3 days a week). After 4 weeks, both groups will be evaluated again. To measure the short-term effect, the respiratory exercise program will be started after the 1st evaluation in the study group, and the 2nd evaluation will be made after the first session.

Canan Demir will perform breathing exercises, and the other researchers who will evaluate will not know which group the participants are in. In this way, the study will be single-blinded.

Translated with www.DeepL.com/Translator (free version)

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* To be between the ages of 18-30
* Not having any problems that prevent breathing exercises

Exclusion Criteria:

* Acute infection or chronic disease of neurological, psychiatric, orthopedic, cardiological, rheumatological, etc. origin
* Having had any injury and/or operation (trauma, surgery, fracture, etc.) in the last 6 months
* Regular medication use
* Presence of respiratory disease (asthma, COPD, etc...)
Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis

The purpose of this study is to determine whether etrasimod (APD334) is a safe and effective treatment for ulcerative colitis after 52 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Participants who completed the APD334-003 (NCT02447302) study

Exclusion Criteria:

* Participants who did not complete the APD334-003 study
Efficacy and Safety of Tranexamic Acid in Cytoreductive Surgery for Ovarian Cancer

Tranexamic acid has been used in surgery for more than 30 years. It's effect on reducing bleeding and blood transfusing has been demonstrated.

In our hospital, the amount of cytorsductive surgery for ovarian cancer is big. During the perioperation , bleeding probability is high, and the supply of blood products is limited. In order to reduce bleeding, we're planning to use tranexamic acid in the operations.

In this experiment, we will observe the efficacy of tranexamic acid in cytoreductive surgery for ovarian cancer, find the best dosage which can reach the desired effect, and the possible side-effect.

We performed a single blind, prospective, randomised control trial (RCT) . The patients randomised assigned to three groups. Low dose TXA, high dose TXA or a placebo of IV saline which will be infused prior to skin incision in patients undergoing elective cytorsductive surgery for ovarian cancer .

Intraoperative blood loss will be estimated by the volume in the suction drains and by weighing the swabs. Postoperative blood loss will be estimated by the volume in the drains.

The other secondary outcomes will be inclued perioperation transfusion volume, thromboembolic complications, ICU length of stay (LOS), hospital LOS, adverse thrombogenic events within 30 days, 30-day all-cause readmission and so on.

Eligibility Criteria:
Inclusion Criteria:

1. sign the informed consent
2. Aged 20-70 years
3. ovarian cancer patients, staged IIIB - C or above

3) ASA I - II

Exclusion Criteria:

1. tranexamic acid allergy
2. pregnancy and lactation
3. only lymph node metastasise
4. history of mental disorder, immune system disorder
5. history of epilepsy, dyschromatopsia
6. arrhythmia
7. history of renal insufficiency
8. thrombosis related disease
9. Hb \< 90 g/dL
10. using anticoagulant drugs (not including aspirin discontinuation 1 week
11. having participated in other clinical trials, or refusing to join the research.