cyrilzakka/clinical-trials huggingface dataset:
Histocompatibility Leukocyte Antigen (HLA)-A*0201 Restricted Peptide Vaccine Therapy in Patients With Esophageal Cancer

The purpose of this study is to evaluate the safety and time to progression of HLA-A\*0201 restricted epitope peptides URLC10, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.

URLC10 has been identified as cancer specific molecules especially in non small cell lung cancer using genome-wide expression profile analysis by cDNA microarray technique. In a prior study, it has been shown that URLC10 is upregulated in human esophageal tumors. VEGF receptor 1 and 2 are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific CTL response in vitro and vivo. According to these findings, in this trial, we evaluate the safety, immunological and clinical response of those peptides. Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, the URLC10-117 peptide(1mg), VEGFR1 peptide(1mg) and VEGFR2 peptide(1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection. Repeated cycles of vaccine will be administered until patients develop progressive disease or unacceptable toxicity, whichever occurs first. In the phase I study, we evaluate the safety and tolerability of these peptide vaccines. In the following phase II study, we evaluate the immunological and clinical response of this vaccine therapy.

Eligibility Criteria:
Inclusion Criteria:

* Advanced or recurrent esophageal cancer
* Resistant against conventional chemotherapy or difficult to continue the chemotherapy due to intolerable side effect(s)
* ECOG performance status 0-2
* Life expectancy \> 3 months
* HLA-A\*0201
* Laboratory values as follows 2000/mm3\<WBC\<15000/mm3 Platelet count\>100000/mm3 Bilirubin \< 3.0mg/dl Asparate transaminase \< 150IU/L Alanine transaminase \< 150IU/L Creatinine \< 3.0mg/dl
* Able and willing to give valid written informed consent

Exclusion Criteria:

* Pregnancy (woman of childbearing potential:Refusal or inability to use effective means of contraception)
* Breastfeeding
* Active or uncontrolled infection
* Unhealed external wound
* Concurrent treatment with steroids or immunosuppressing agent
* Prior chemotherapy, radiation therapy, and/or immunotherapy within 4 weeks
* Uncontrolled brain and/or intraspinal metastasis
* Decision of unsuitableness by principal investigator or physician-in-charge
Inspiratory Muscle Training and Physical Fitness in Children With Down Syndrome Randomized Control Trial

The purpose of this study is to investigate the effect of inspiratory muscle training on physical fitness in Down syndrome children. Twenty Down syndrome children from both genders ranged in age chronologically from seven to ten years will be selected to participate in this study. Selection of the study sample and evaluation of physical fitness improvement as well as Inspiratory Muscle training will be conducted in the Down Syndrome Charitable Association (DSCA), Riyadh City.

The study sample will be divided randomly into two equal groups of (A \& B). All the children participated in the current study will receive 30 minutes of treatment session of aerobic exercise, group B will receive first 30 minutes of IMT then take a period time of rest about 30 minutes before starting the aerobic exercise. Exercise frequency three times per week for a period of three successive months.

The Body mass index (BMI) of each participated child will be determined by measuring weight/ Kg and height/ m2 using Electronic weight and height scale to include BMI ≥ 29 Kg/ m2 to exclude the obese children. Also using Six Minute Walk Test (6MWT) for measuring the aerobic capacity and Pulse Oxymeter for measuring pulse rate and Oxygen saturation. In addition, The Gio Digital pressure gauge will be used to assess Respiratory Muscle Strength of children by determining the Maximal Inspiratory (MIP) and Expiratory Pressure (MEP) which used to detect the inspiratory training intensity and reflect the improvement in respiratory muscle strength after training program. Brockport Physical Fitness Test (BPFT) will be used to measure physical fitness of the participated children. The participated children will be assessed before and after three successive months .

The obtained results of this study will measure Maximal Inspiratory (MIP) and Expiratory Pressure (MEP), Aerobic capacity, Musculoskeletal Function and Maximum Heart Rate (HR Max.) to determine the significant improvement of participated children


Eligibility Criteria:
Inclusion Criteria:

* children with a body mass index (BMI) ≥ 25 kg/m2, and
* children with the ability to understand and follow verbal commands and instructions used during training and tests

Exclusion Criteria:

* with neurological, visual, or auditory defect,
* with asthma or any chronic chest diseases,
* with significant tightness or deformities in the lower limbs,
* with obesity, or
* who performed regular physical activity
Assessment of Novaloc and Locator Attachment Systems

The aim of the current study is to assess the effect of two types of attachments (Locator, Novaloc) on the supporting structures both mechanically using stress strain analysis and biologically through measuring bone height using cbct.

14 Completely edentulous patients will be divided into two groups each group contains seven patients: Group One: Each patient will be restored with 4 implant retained maxillary overdenture using Peek retention inserts attachment system and Bone Level Ti-Zr implants.

Group Two: Each patient will be restored with 4 implant retained maxillary overdenture using Nylon retention insert attachment system and Bone Level Ti implants.

Bone height in millimeters will then be evaluated around each implant using cone beam computed tomography at the time of placement of attachments, 6 months, 1 year

Eligibility Criteria:
Inclusion Criteria:

* Completely edentulous patient with u shaped dental arch.
* Systemically free.
* Patients completed all extraction at least 6 months before surgery.
* Patients Tempromandibular joint is free from any disease.
* Patient's mouth opening is proper for accessibility during surgery and implant placement.
* Sufficient bone level (length, and width) at implant placement site.
* Presence of enough bone height at implant site close to the maxillary sinus.
* Absence of sinus pneumatization.

Exclusion Criteria:

* Heavy smoker.
* Patients with bone diseases.
* Patients having a history of parafunctional habits.
* Patients with diabetes mellitus.
* Patients on chemotherapy or radiotherapy.
* Patients on any medications that reduce wound healing.
* Patients without sufficient bone level (height, width).
* Patients with sinus pneumatization.
Evaluate the Efficacy and Safety of TQC2731 Injection in Patients With Severe Asthma.

This is a phase II, multicenter, double-blind, randomized, parallel group, placebo-controlled clinical study to evaluate the effect of three doses of TQC2731 on Annualized Asthma Exacerbation Rates(AAER) in adult subjects with poor control of severe asthma. It is estimated that 220 subjects will be included. The subjects will receive TQC2731 (70 mg Q4w, 210 mg Q4w, 420 mg Q4w) or placebo (Q4w) administered by Subcutaneous (SC) in the ratio of 1:1:1:1.

The study comprised a 5 to 6-week screening period, a 52-week treatment period and a 12-week follow-up period. During the treatment period, the study drug will be administered from day 0 until week 48. The study drug was not administered at the 52nd week.


Eligibility Criteria:
Inclusion Criteria:

* 1 Age. 18-75
* 2 Documented physician-diagnosed asthma for at least 12 months before visit 1.
* 3 Subjects who have received a physician-prescribed asthma controller medication with medium or high dose inhaled glucocorticosteroid (ICS) for at least 12 months before visit 1.
* 4 Documented treatment with a total daily dose of either medium or high dose ICS for at least 3 months before visit 1.
* 5 At least one additional maintenance asthma controller medication such as Long acting β2 receptor agonist (LABA), leukotriene receptor antagonist (LTRA), theophylline, Long-acting muscarinic antagonists (LAMA), sodium cromoglycate, etc. is required according to standard practice of care and must be documented for at least 3 months.
* 6 Morning pre-BD FEV1 \<80% predicted normal At visit 2 or visit 2a.
* 7 Evidence of asthma as documented by either: Documented historical reversibility of FEV1 ≥12% and ≥200 mL in the previous 12 months before visit 1 OR Post-BD (albuterol/salbutamol) reversibility of FEV1 ≥12% and ≥200 mL during screening At visit 2 or visit 2a.
* 8 Documented history of at least 2 asthma exacerbation events within 12 months before visit 1.
* 9 ACQ-6 score ≥1.5 at visit 1
* 10 Body weight ≥ 40 kg at visit 1.

Exclusion Criteria:

* 1 Pulmonary disease other than asthma.
* 2 History of cancer.
* 3 Current smokers or subjects with smoking history ≥10 pack-years.
* 4 Hepatitis B, C, human immunodeficiency virus (HIV) or Syphilis.
* 5 History of anaphylaxis following any biologic therapy.
* 6 History of chronic alcohol or drug abuse within 12 months.
* 7 History of a clinically significant infection.
* 8 Pregnant or breastfeeding.
Quality Project Malnutrition Intensive Care

Observational study to investigate nutrition state in all admitted patients in ICU. Measurement by BIVA and SNAQ score.

Malnutrition is a great problem in healthcare, its related to mortality, infections and length of stay. Observational study to investigate nutrition state in all admitted patients in ICU. Measurement by BIVA and SNAQ score.

All patients were asked for their nutrition state by SNAQ and the BIVA measurement is done by a trained doctor.

Eligibility Criteria:
Inclusion Criteria:

* admission ICU

Exclusion Criteria:

* none
The Effect of Virtual Reality on Pain and Anxiety During Colposcopic Biopsy: a Randomized Controlled Trial

The study was planned as a prospective, two-arm (1:1) randomized controlled experimental study to determine the effect of virtual reality applied during colposcopic biopsy on pain and anxiety. The research hypothesis of the research are as follows; H1a: There is a difference between the pain levels of the virtual reality group and the control group after colposcopic biopsy.

H1b: There is a difference between the anxiety levels of the virtual reality group and the control group after colposcopic biopsy.

Methods: In the study, 82 women who underwent colposcopic biopsy at Mersin University Hospital Gynecological Oncology Polyclinic were randomly assigned to experimental and control groups. Before the application, new protective covers will be attached to the headset parts of the virtual reality (VR) glasses that the researchers already have for each woman in the experimental group. Videos with forest and sea views will be presented to the woman's preference through the VR program loaded on the phone, the video selected by the woman will be opened and the phone will be inserted into the VR glasses. After the woman is positioned for the gynecological surgical procedure, the VR glasses will be put on and will remain on during the procedure. The VR application will be terminated after the colposcopic biopsy is completed. The Visual Analog Scale (VAS) will be filled in during the procedure and 15 minutes after the colposcopic biopsy, and the State-Trait Anxiety Inventory (STAI-S) will be filled in before and 15 minutes after the colposcopic biopsy. Only standard care will be given to women in the control group during colposcopy. The primary expected outcome of the study is the effect of virtual reality on pain in women undergoing colposcopic biopsy. The secondary expected outcome of the study is to determine the effect of virtual reality on anxiety.

Eligibility Criteria:
Inclusion Criteria:

* Women over the age of 18,
* Subjected to colposcopic biopsy,
* Not using a medication that directly affects vital signs,
* Not using antidepressants, anxiolytics or sedatives,
* Not using analgesics or anesthetics 24 hours before the procedure,
* Not having any psychiatric illness,
* Not having vision, hearing or perception problems,
* Not having communication problems (can speak Turkish),
* Women who agree to participate in the study verbally and in writing.

Exclusion Criteria:

* Women under the age of 18,
* Those who have not undergone colposcopic biopsy,
* Those who are taking a medication that directly affects vital signs,
* Those who are taking antidepressants, anxiolytics and sedatives,
* Those who are taking analgesics or anesthetics 24 hours before the procedure,
* Those who have any psychiatric illness,
* Those who have vision, hearing and perception problems,
* Those who have communication problems (cannot speak Turkish),
* Those who have diseases that cause movement sensitivity,
* Those who cannot watch the entire video,
* Women who do not accept to participate in the research verbally or in writing.
Diffusion-weighted MRI to Predict Treatment Response in Stereotactic Radiotherapy of Central Nervous System (CNS) Metastases

Stereotactic radiation therapy is an important and common method of treating brain metastases in patients with malignant disease. Today, however, there are no methods available to determine the metastasis' radiation sensitivity in advance and treatment responses can only be seen by changing of the size of the metastasis on conventional X-ray examinations, computed tomography (CT) and magnetic resonance imaging (MRI). Changes in the size of the metastases is something that is often seen weeks / months after treatment is completed. At Lund University Hospital, a new imaging technique, diffusional variance decomposition (DIVIDE), has now been developed. With this technique, the scatter in isotropic and anisotropic diffusion can be measured for each measuring point, which provides significantly more information about the properties of the tissue compared to current methods.


Eligibility Criteria:
Inclusion Criteria:

1. Patients prescribed stereotactic radiation therapy to the brain, where MRI imaging is included in the treatment preparations.
2. Cohesive remaining solid tumor component of ≥10mm.
3. Age ≥18 years.
4. World Health Organisation (WHO) performance status 0-1.

Exclusion Criteria:

1. Inability to decide for oneself on participation in the study.
2. Inability to understand the Swedish language.
3. Metastases close to the base of the skull.
4. Contraindications to conducting an MRI examination.
5. Contraindications to obtaining contrast media during MRI examination.
6. Expected survival less than 6 months.
7. Previous radiation treatment to the same site in the brain, i.e. current treatment is a rope radiation.

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Observational Study to Assess Protection to Mumps in Children Received One-dose Mumps-containing Vaccine

This study was aimed to conduct a 3-year perspective study to observe the immunological effect of one-dose mumps-containing vaccine, monitor the incidence of mumps in vaccinated population aged 3-7 years，and provide basis for adjusting MMR immunization strategy in Jiangsu province, China.

in 3-7 years old children with high risk of mumps, epidemiological investigation of the serum IgG antibody level were conducted, and then a prospective observational cohort was established in the population with a history of mumps vaccination, and the incidence of mumps in each antibody level group will be observed, the relationship between different antibody levels and the incidence after mumps vaccinated were analyzed, to explore attenuation of mumps IgG antibody levels in the body,S79 vaccine strain against F genotype mumps' antigenic cross-reactivity and the protective effect of antibodies.

Eligibility Criteria:
Inclusion Criteria:

1. Children aged 3-7 years old;
2. local resident children living at least 3 months;
3. physical health, has been vaccinated at least once a dose of MuV

Exclusion Criteria:

1. did not administer MuV;
2. refused to collect venous blood;
3. have been infected with mumps;
4. have serious illness or other reasons should not participate in the study after clinical evaluation
Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Distress Syndrome (RDS) in Premature Infants

To evaluate the feasibility, safety and tolerability of aerosolized lucinactant delivered by nasal continuous positive airway pressure (nCPAP) for the prevention of respiratory distress syndrome (RDS) in premature infants.

Use of a device in the early treatment of RDS that permits the effective aerosolization of an exogenous surfactant that also allows for the simultaneous delivery of continuous positive airway pressure would permit the delivery of surfactant to the distal airways without intubation. This approach could reduce the frequency of severity of the adverse events relative to endotracheal intubation and surfactant administration via bolus.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age 28-32 completed weeks, inclusive
* Placement of arterial line
* Successful initiation of nCPAP
* Informed Consent

Exclusion Criteria:

* Heart rate that cannot be stabilized \>100 bpm within 5 minutes of birth
* Five (5) minute Apgar score ≤ 3
* Major congenital malformation(s) diagnosed antenatally or noted immediately after birth
* Other disease(s) or conditions potentially interfering with cardiopulmonary function
* Mother with prolonged rupture of membranes \> 2 weeks
* Known or suspected chromosomal abnormality
* Need for chest compressions or administration of epinephrine, bicarbonate, or fluid boluses in the delivery room
* Need for mechanical ventilation within 30 minutes of birth
Diagnosis and Management of Inflammatory and Infectious Diseases

This protocol is being established to cover the evaluation of patients with inflammatory and/or infectious diseases which are not covered under previously existing protocols. The purpose of such a protocol is that frequently patients are referred to us with either diagnosed or undiagnosed illnesses which would be of interest to our teaching program or which would serve as a source of patients to subsequently be entered into established, ongoing protocol studies. Such patients will be admitted to the protocol and handled according to accepted medical practice of diagnosis and treatment....

Study Description:

This protocol was established in 1978 to evaluate patients with diagnosed and undiagnosed inflammatory and/or infectious diseases that are of scientific interest. Once diagnosis is made patients are referred to relevant NIH protocols for follow-up. If an NIH protocol does not exist for the condition, participants receive the required clinical standard of care treatment through an outside provider or through this protocol if a provider with the necessary expertise cannot be found. It is a minimal risk study.

Objective:

To evaluate patients with possible infectious and/or inflammatory diseases in order to collect data/samples through the diagnosis of infectious and inflammatory conditions (including in terms of clinical, immunologic, and metabolic features) further characterize, and treat infectious and inflammatory conditions through the collection of clinical specimens, medical records and in-person assessments

To provide a repository of information on enrolled participants to allow for hypothesis generation in future research

Eligibility Criteria:
* INCLUSION CRITERIA:

  1. Known or suspected exposure to infection, as determined by the Principal Investigator OR Presence of signs and symptoms of an infectious or inflammatory disease
  2. Age range: 3 years of age and older.
  3. NIAID/LIR investigator who has an interest in the patient s illness and is willing to serve as attending physician to supervise the patient's medical care at the NIH.
  4. Primary physician outside the NIH
  5. The patient or the patient's Legally Authorized Representative is capable of informed consent and signs the consent form. The consent form will be signed by parents or guardians of patients under the age of 18

EXCLUSION CRITERIA:

1. Pregnant.
2. Presence of conditions that, in the judgment of the investigator, may put the participant at undue risk or make them unsuitable for participation in the study.
Acute Effects of GLP-1 on Renal Hemodynamics

This study investigates the hypothesis, that GLP-1's suppression of ANG II and natriuretic action increase medullary perfusion and decrease oxygen consumption, leading to higher tissue oxygenation.

Human studies have recently demonstrated a significant natriuretic effect of GLP-1 when the extracellular fluid volume (ECFV) is expanded by intravenous sodium-loading; in these studies, there was a suppression of ANG II with no change in net renal hemodynamics, pointing to a tubular mechanism for reduced NaCl reabsorption secondary to the ANG II suppression. In the current randomized and controlled study, investigators aim to test the hypothesis that GLP-1's suppression of ANG II and natriuretic action increase medullary perfusion and decrease oxygen consumption, leading to higher tissue oxygenation. Thus, contributing to the renoprotective action of GLP-1.

Under fixed sodium intake for 4 days before each study day, 10 healthy male participants will be investigated during a 1-hour infusion of GLP-1 (1.5 pmol/kg/min) or vehicle together with an intravenous infusion of 0.9% NaCl. Interleaved measurements of RAF, oxygenation (T2\*) and perfusion by arterial spin labeling in the renal cortex and medulla at fixed time points will be conducted, using Magnetic Resonance Imaging (MRI).

Eligibility Criteria:
Inclusion Criteria:

* Normal health demonstrated by medical examination.
* Normal values for fasting plasma glucose, total cholesterol, triglyceride, HDL, LDL, creatinine, AST, ALT and electrolyte concentrations.

Exclusion Criteria:

* Immunosuppressive treatment for the previous 12 months.
* Alcohol abuse.
* Medical treatment with oral glucocorticoids, dipeptidyl peptidase-4 (DPP-4) inhibitors, or GLP-1 receptor agonists that, in the opinion of the investigator, may interfere with glucose metabolism.
* Use of lithium.
* Medical treatment that affects insulin secretion or cardiovascular efficacy goals.
* Liver disease (ALT\> 2 x normal value).
* Renal impairment (creatinine\> 130 µM and / or albuminuria).
* Severe claustrophobia.
* MRI incompatible foreign bodies.