cyrilzakka/clinical-trials huggingface dataset:
Peptide-based Glioma Vaccine IMA950 in Patients With Glioblastoma

BACKGROUND: Active immunotherapy of cancer is based on the premise that the vaccine raises a cytotoxic immune response to tumor-associated antigens, thereby destroying malignant cells without harming normal cells.

IMA950 is a therapeutic multi-peptide vaccine containing 11 tumor-associated peptides (TUMAPs) found in a majority of glioblastomas, and is designed to activate TUMAP-specific T cells. The use of 11 TUMAPs increases the likelihood of a multi-clonal, highly specific T-cell response against tumor cells leading to decreased likelihood of immune evasion of the tumor by down-regulation of target antigens.

PURPOSE: The primary objective of this study is to determine the safety and tolerability of IMA950 when given with cyclophosphamide, granulocyte macrophage-colony stimulating factor (GM-CSF) and imiquimod in patients with glioblastoma and to determine if IMA950 shows sufficient immunogenicity in these patients.

ELIGIBILITY: Patients with histologically proven GBMs who have completed radiotherapy, and have stable disease following at least 4 cycles of adjuvant temozolomide.


Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven glioblastoma
* Stable disease following ≥ 4 cycles of adjuvant temozolomide
* No progression or recurrence of disease

PATIENT CHARACTERISTICS:

* HLA-A\*02 positive
* ≥ 18 years old
* Life expectancy \> 8 weeks
* Karnofsky performance status ≥ 60
* WBC \>3,500/µL
* ALC \>350/mm3
* ANC \>1,500/mm3
* Platelet count \>100,000/mm3
* Hemoglobin \>10gm/dL
* AST, ALT and alkaline phosphatase \<2.5 times upper limit of normal (ULN)
* Bilirubin \<1.5 times ULN
* Creatinine \<1.5 mg/dL and/or creatinine clearance \>60cc/min
* Serum potassium, magnesium and calcium within normals levels (supplementation is allowed)
* Not pregnant or nursing
* Negative pregnancy test
* Practice birth control during and for 2 months after treatment with IMA950 (both genders)
* Women of childbearing age must agree to use adequate contraceptive methods
* No significant active hepatic, renal, infectious or psychiatric disease
* No HIV, active hepatitis infection, or any other active severe infectious disease
* No history of autoimmune disease or immunosuppression
* No clinically significant cardiovascular event within 3 months before study entry or an increased risk for ventricular arrhythmia
* No malignancy other than glioblastoma that required treatment during the last 12 months

PRIOR and/or CONCURRENT THERAPY:

* See Disease Characteristics
* Completed radiotherapy and at least 4 cycles of adjuvant temozolomide
* Not be receiving steroids OR be on stable dose of steroids for ≥ 5 days prior to registration
* No other prior immunotherapy for glioblastoma
* No major surgery within 4 weeks prior to treatment start
* At least 4 weeks from cytotoxic therapies (incl. temozolomide)
* At least 2 weeks from non-cytotoxic therapies (e.g. interferon, tamoxifen)
* At least 3 weeks from bevacizumab
* No current treatment with imiquimod; prior use of imiquimod is allowed
Effectiveness of Parent-Led Interventions in Reducing Infant Hypersensitivity to Pain

The aim of this study is to find out the effects of routinely using different types of pain-relieving strategies during routine immunization injections performed in infants.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy infants undergoing vaccination.

Exclusion Criteria:

1. preterm birth (\<37 weeks gestation)
2. prior hospitalization/surgery (other than postnatal care),
3. documented/ suspected sensitivity/allergy to amide anaesthetics/vaccines,
4. mother plans to breastfeed or to use topical anesthetics or sugar water during injection.
Ultraviolet-C Effectiveness in the Management of Pressure Ulcers in People With Spinal Cord Injury

The objective of the study is to examine the effectiveness of Ultraviolet-C (UVC) for healing pressure ulcers in people with spinal cord injury. UVC is a form of radiation similar to sunlight but it is normally absorbed in the earth's atmosphere. Participants will be assigned by chance to receive placebo-UVC or real UVC treatment, in addition to receiving wound care according to best practice guidelines. The hypothesis is that UVC-treated wounds will heal at a faster rate than wounds receiving placebo treatment.

Given that pressure ulcers impact on an individual's quality of life, and generate high costs to the overall health care system, further work is needed to explore alternative means of pressure ulcer treatment.

UVC or placebo UVC will be applied to wounds three times per week. Intact skin around the wound edge and the wound base will be irradiated.

Eligibility Criteria:
Inclusion Criteria:

* traumatic, non-traumatic or congenital spinal cord injury C2-L2
* pressure ulcer stage 2 or higher

Exclusion Criteria:

* neoplastic wound
* wound surgically repaired within past 3 months
* wound currently treated with negative pressure therapy
Treatment of Severe COVID-19 Patients Using Secretome of Hypoxia-Mesenchymal Stem Cells in Indonesia

In this randomized controlled trial (RCT), severe cases of COVID-19 infection will be treated with secretome of hypoxia-mesenchymal stem cells. The improvement in clinical, laboratory, and radiological manifestations will be evaluated in treated patients compared with the control group.

The devastating effect of severe acute respiratory syndrome coronavirus-2 (SARS COV-2) infection is caused by a robust cytokine storm that leads to lung tissue damage. Several studies reported a correlation between disease severity and the release of excessive proinflammatory cytokines, such as tumor necrosis factor-α (TNF-α), IL-6, IL-1, IFN-Υ, IFN-Υ-induced protein 10 (IP10), monocyte chemoattractant protein-1 (MCP-1), macrophage inflammatory protein-1a (MIP-1a), and granulocyte-colony stimulating factor (G-CSF). This finding was confirmed by the high level of plasma cytokines found in most severe COVID-19 patients associated with extensive lung damage. Therefore, finding an effective therapeutic option to control the devastating cytokine storm of COVID-19 and regenerate the damaged lung is crucial.

Previous studies reported that the hypoxic condition of MSCs could enhance the release of their active soluble molecules known as Secretome-MSCs (S-MSCs), such as IL-10 and TGF-β that useful in alleviating inflammation. Moreover, they could also increase the expression of growth factors such as VEGF and PDGF that accelerate lung injury improvement. These active molecules could potentially serve as a biological therapeutic agent for treating the severe SARS-CoV-2 infection. According to recent studies, we successfully isolated the S-MSCs from their culture medium using tangential flow filtration (TFF) strategy with several molecular weight cut-off category. This study investigated the clinical outcomes of severe COVID-19 patients with several comorbidities treated with S-MSCs in Indonesia.

Eligibility Criteria:
Inclusion Criteria:

1. Patients whose clinical and laboratory test results have a positive diagnosis of Covid-19.
2. Patients who are willing to participate as subjects in the study by signing the informed content.
3. Criteria for Berlin to enter ARDS (moderate and severe) with or without a ventilator:

   * PaO2 / FiO2: moderate 100-200
   * PaO2 / FiO2: severe \<100
4. One or more comorbid history
5. SOFA score

Exclusion Criteria:

1. The Covid19 patient has fibrosis (based on the results of the chest X-ray or CT chest)
2. ECOG 4 performance status, decreased irreversible consciousness, brain stem death.
3. Severe NYHA III / IV heart failure
4. Pregnant women
Heparin Versus Normal Saline in Peripherally Inserted Central Catheter Lines

The study team will be performing a study comparing the use of Heparin Flushes vs. Normal Saline Flushes in making sure central lines stay open. The participants will be placed in a group to receive the University of Texas Southwestern Medical Center (UTSW) Standard of Care (control group) for maintaining central lines, or a group to receive Normal Saline Flushes only (experimental group) to keep their central line open. The participants electronic medical record will be reviewed by study team members for the inclusion/exclusion criteria, the participants central line will be assessed by an 11 Blue BMT nurse every 12 hours, and they may be asked questions regarding their medical history during their stay on 11 Blue BMT. If a participant is discharged or transferred off of the 11 Blue BMT unit, they will no longer be included in the study and their central line maintenance will return to the UTSW Standard of Care. Participants in this study may be at risk for central line occlusion (a blood clot) which could require intervention to regain the free flow of fluids and use of the central line. The study team predicts there will be no increase in the rate of line occlusion when using Normal Saline Flushes only to maintain the free flow of fluids through participants central line. The study team also hopes the results of this study will help to improve patient outcomes by decreasing risk of infection, heparin associated complications, and costs.


Eligibility Criteria:
Inclusion Criteria:

* Oncology patients
* Admitted to 11Blue Bone Marrow Transplant Unit at Clements University Hospital University of Texas Southwestern Medical Center
* Ages 18-80 years
* Pre-existing or newly placed PICC line
* PICC line with good blood return (defined as: "brisk blood return of 3cc")
* Flushes without difficulty

Exclusion Criteria:

* Patient less than 18 years of age or greater than 80 years of age
* Refused or unable to give consent to the study
* Patient admitted to the 11Blue BMT unit with any line other than a PICC line, or multiple lines
* Patient admitted to 11Blue BMT for active transplant
* Patient with a coagulopathy diagnosis
* Patient on therapeutic dose of anticoagulants for documented Deep Vein Thrombosis or Pulmonary Embolism
* Patient on inpatient hospice/comfort care
* Patient transferred off 11B BMT unit onto another floor
Impact of Postural Balance Changes on Low Back Pain During Pregnancy

this study will be conducted to determine the impact of postural balance changes on low back pain during pregnancy

Back pain is a major problem in the general population, and it is thought to be even more common in pregnant women who have given birth. It has been hypothesized that this type of pregnancy-related low back pain (LBP) may be related to changes in lumbar posture, perhaps accompanied by stretching abdominal muscles or specific hormonal effects of pregnancy .During pregnancy, many hormonal, anatomical, and musculoskeletal changes occur. These changes alter the postural balance and increase the risk of falls. Falls during pregnancy can cause maternal and foetal injuries. Moreover, the incidence of falls during pregnancy is higher compared to non-pregnant women of the same age. The risk of falls increases with the gestational age, and most falls are experienced in the third trimester. so, this study will be designed to conduct new information about the relation between postural changes and low back pain during pregnancy

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women in 2nd and 3rd trimesters.
* Pregnant women suffering from low back pain
* Their Age will range from 20-35 years.
* Their Body mass index (BMI) will be less than 35 kg/m2

Exclusion Criteria:

* Non pregnant women.
* Women who have any history of diseases associated with balance disorder
* Women who have any Neurological disorders.
* Women who have Lower limbs deformities
* Women who have Optical problems and disorders
* Women who have Cerebrovascular disease
SEgmentectomy Versus Lobectomy in T1C Non-Small Cell Lung Cancer (SELTIC)

The goal of this clinical trial is to investigate the role of segmentectomy in clinical T1c (2-3 cm) non-small cell lung cancer (NSCLC). The main questions we aim to answer are:

1. Is segmentectomy non-inferior to lobectomy in cT1c NSCLC in terms of overall and recurrence free survival?
2. What are the mortality and morbidity rates of segmentectomy compared to lobectomy?

Researchers will compare segmentectomy and lobectomy in terms of overall and recurrence free survival.

Participants will:

* Undergo either pulmonary lobectomy or segmentectomy with mediastinal nodal dissection
* Be followed up with a chest CT in every 3 months in first year, every 6 months in second year and every year for following 3 years


Eligibility Criteria:
Inclusion Criteria:

* Clinical T1c NSCLC
* Parenchymal nodule \>2 cm in diameter
* Parenchymal nodule ≤3 cm in diameter
* Consolidation / Tumor Rate (CTR) ≥ 0.50
* Definitive pathological diagnosis of NSCLC preoperative or intraoperatively
* No evidence of distant metastasis
* No evidence of N2 disease
* Adequate pulmonary functions for lobectomy or segmentectomy

Exclusion Criteria:

* Pure GGO lesions
* Pathologic diagnosis other than NSCLC
* Technically not suitable for simple or complex segmentectomy, or lobectomy
* Evidence of distant metastasis
* Pathologically confirmed N2 or N3 disease
* Major comorbidity that precludes surgery
* Intraoperative mediastinal nodal dissection of less than 3 lymph node stations
* Prior malignancy in five years
Abdominal-Kegel Exercise and the Effect of Telemedicine in Stress Urinary Incontinence

Urinary incontinence is a very common health problem that reduces the quality of life mostly in women. Behavioral therapy (lifestyle changes, abdominal-Kegel exercises) is recommended as the first choice in the treatment of the disease. It is known that surgical and medical treatment cannot give a definite result. The application of behavioral therapy with telemedicine has advantages such as reducing the cost and increasing the treatment rate. In this study, it is aimed to evaluate the effect of telemedicine practices on compliance with multi-module behavioral therapy in women with stress urinary incontinence.

The study is a randomized controlled study to be conducted in female patients between the ages of 20-65 who applied to the Eskişehir City Hospital urology outpatient clinic and diagnosed with stress urinary incontinence.

When type 1 (α) error was 5%, type 2 error (1-β) was 95%, and the effect size was accepted as 0.5, it was calculated that there should be at least 47 people in the groups.

Stratified and block randomization will be used to recruit patients into study groups.

The patients will be evaluated with the QUID test, risk assessment questionnaire in patients with stress urinary incontinence, incontinence short test, bladder diary, daily urinary incontinence, a notebook to record the duration of the exercises to be performed, quality of life scale and lifestyle changes questioning form.

The intervention group will be re-evaluated as a result of the intervention with measurement tools.

Intervention group: Brochure about incontinence will be given, web-based training will be applied, SMS will be sent every day according to the risks.

Control group: Only brochure will be given.

It is expected that a low-cost application to be developed after the study will reduce the complaints of the patients, increase their quality of life and have a positive effect on women's health.

It is difficult for physicians to allocate sufficient time to convey lifestyle changes and exercises to patients with stress urinary incontinence during their busy work hours in the clinic. After the success to be achieved, the usage rate of the website to be prepared will be increased through various scientific platforms and associations.

Eligibility Criteria:
Inclusion Criteria:

* having symptoms of UI for at least the last 6 months,
* QUID stress score is ≥ 4,
* diagnosed with SUI as a result of the evaluation made by a specialist physician, have minimal skills in using new technologies
* Those who have the opportunity to access the web page to be prepared can participate in the research.

Exclusion Criteria:

* History of using medical therapy for UI,
* existing urinary infection,
* diabetes mellitus,
* nervous system disease (such as multiple sclerosis, cerebrovascular disease),
* psychiatric illness or dementia,
* genitourinary malignancy,
* having limited range of motion in the foot or pelvic region,
* pregnant
Characterizing Inflammatory Bowel Disease With 68Ga-FAPI PET/CT

68Ga-FAPI has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation,such as inflammatory bowel disease. And it might be more sensitive than FDG in detecting a certain type of inflammations according to our preliminary research. Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for diagnosis, therapy response assessment and follow-up of inflammatory bowel disease than 18F-FDG PET/CT.

Inflammatory bowel disease (IBD) is comprised of two major disorders: ulcerative colitis (UC) and Crohn's disease(CD).CD is an autoimmune condition resulting in chronic gut inflammation that can be complicated by intestinal fibrosis and stricture formation. Ulcerative colitis is characterized by recurring episodes of inflammation limited to the mucosal layer of the colon. It commonly involves the rectum and may extend in a proximal and continuous fashion to involve other parts of the colon. Studies identified FAP to be overexpressed in uninflamed strictures compared with nonstrictured colonic regions in biopsies taken from Crohn's disease patients. But preliminary studies showed FAP was not overexpressed in colonic biopsies taken from healthy individuals or individuals with ulcerative colitis.68Ga-FAPI has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and inflammation. Recently we have published an article of the application of 68Ga-FAPI in IgG4-related disease which showed it was more sensitive than FDG in detecting a certain type of inflammations. Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for diagnosis, therapy response assessment and follow-up of IBD than 18F-FDG PET/CT.

Eligibility Criteria:
Inclusion Criteria:

* suspected or confirmed untreated inflammatory bowel disease patients;
* 18F-FDG PET/CT within two weeks;
* signed written consent.

Exclusion Criteria:

* pregnancy;
* breastfeeding;
* known allergy against FAPI
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Measurement of Platelet Dense Granule Release in Healthy Volunteers

Aspirin has been shown to reduce cardiovascular events in at risk individuals. Elucidation of mechanisms of aspirin resistance and a possible loss of effect of aspirin over time with chronic aspirin treatment necessitate a more precise method of measuring the "release phase" of platelet activation, including the release of dense granules from platelets.

This is a proposal for a pilot study to evaluate the feasibility of measuring 5-hydroxytryptamine (5-HT) release from platelets as an indicator of dense granule release during platelet activation in volunteers taking aspirin.

One phase of platelet response to activating agonists involves release of dense granules, which are known to contain 5HT (serotonin) and ATP. There are various methods of measuring the degranulation of platelets: ATP release can be measured using a lumiaggregometer, and release of 14C radiolabeled 5-HT from platelets. Using the aggregometer and a 14C labeled 5-HT assay can be used to measure 5-HT release from platelets.

Our experience suggests that ADP-induced ATP release is insensitive to detect very low levels of platelet dense granule release, which occurs in aspirin-treated subjects. The pilot study will permit optimizing the method for reliably detecting low levels of 5HT release in patients who achieve submaximal inhibition of the cyclooxygenase during aspirin treatment.

Eligibility Criteria:
Inclusion Criteria:

* Males over age 18
* Non-smokers
* No chronic medical illness
* No chronic medications

Exclusion Criteria:

* ASA/NSAID use previous 14 days.
* History of chronic NSAID use.
* Currently taking NSAIDs, opioid analgesics, corticosteroids, or anticoagulants.
* History of coronary artery disease, myocardial infarction, coronary artery bypass grafting, percutaneous angioplasty, diabetes mellitus or stroke.
* History of hypertension
* BMI \>35
* Smokers
* History of gastric, duodenal, or esophageal ulcers or serious gastrointestinal bleed.
* History of frequent headaches, pain syndrome, or other condition requiring frequent use of analgesics.
* History of adverse reaction to ASA.
* Initial platelet count \<100K/µl or \>500K/µl.
* Initial hematocrit \<35% or \>50%.
* Weight less than 110 pounds.

Female subjects will be excluded to avoid possible confounding uterine smooth muscle production of prostaglandins which various throughout the menstrual cycle.
Factors Affecting Salt Intake in Young Adults

High salt intake is one of the key risk factors for development of high blood pressure and one of the main contributors to cardiovascular disease (CVD) mortality. Despite the efforts to reduce the intake of salt in the UK, current intake still exceeds the recommended values. It is evident that better understanding of this behaviour is necessary to be able to design more effective CVD prevention strategies. This study aims to explore the determinants of salt intake with the focus on genetics, salt taste perception and salt knowledge.

Hypertension is a major cause of cardiovascular disease (CVD) and overall mortality. High dietary salt intake is a major risk factor for hypertension estimated to be responsible for one in ten deaths from CVD events. Salt consumption worldwide and in the UK exceeds the recommendations. One of the main determinants of food intake, and potentially salt, is taste which may be genetically determined. Research exploring the associations between genetics, salt taste and salt intake is scarce. Better understanding of these associations would be of specific interest in younger populations as it has been shown that it is the young adults that have higher preference for salty taste and consequently salt intake. Therefore, the aim of this study is to explore the associations between genetics, salt taste perception and salt intake in young UK adults.

One hundred participants (18-35 years) will be recruited. Salt taste thresholds will be identified using the British Standards Institution sensory analysis method (BS ISO 3972:2011) and preference for salty taste by rating the pleasantness and bitterness of six tomato soups with differing salt concentrations. Salt intake will be measured using five step multiple pass 24-hour recall completed via online platform (Online surveys) for one day of the week and one weekend day. Participants will be genotyped for genetic variants in the SCNN1B and TRPV1 genes coding for ion channels expressed in taste cells.

Eligibility Criteria:
Inclusion Criteria:

- Males or females, aged 18-35 years and healthy.

Exclusion Criteria:

* Current stage 1 or 2 hypertension
* Current or recent (less than one month prior to screening visit) use of antihypertensive medications or medications that affect BP
* Secondary hypertension
* History of cardiovascular disease, including myocardial infarction, congestive heart failure, stroke, and peripheral arterial disease
* Chronic kidney failure
* Peptic ulcer disease requiring treatment during the previous two years
* Currently pregnant women
* Underweight (BMI\<18.5 kg/m2) and obese (BMI\>30 kg/m2)
* Currently adhering to a low sodium diet
* Any illness that permanently alters taste
* Inability or unwillingness to participate or sign informed consent form
* Food allergy