cyrilzakka/clinical-trials huggingface dataset:
Myeloid-derived Suppressor Cells (MDSCs) in OSCC Patients

Oral squamous cell carcinoma (OSCC) has the highest annual increase in the rate of death among the top 10 leading cancers in Taiwan. This research aimed to explore whether increased anti-tumor immunity for OSCCs reduces the recurrence rate or improves survival. We first identified CD33+/CD11b+/HLA-DR-/low/CD14+/- as myeloid-derived suppressor cell (MDSC) surface markers by using flow cytometry to compare the MDSC frequency of OSCCs with blood samples from healthy donors (HDs). We then re-confirmed the suppression of T cell proliferation and function achieved by co-culturing with OSCC-educated MDSCs. We subsequently explore whether using particulate β-glucan as a food-grade supplement promotes the human immune system via subversion of immune modulatory MDSCs. Lastly, we correlated clinicopathological parameters with MDSCs and β-glucan administration to examine anti-tumor immunity, and to predict the therapeutic effect and prognosis in OSCC patients..

Oral squamous cell carcinoma (OSCC) has the highest annual increase in the rate of death among the top 10 leading cancers in Taiwan. This research aimed to explore whether increased anti-tumor immunity for OSCCs reduces the recurrence rate or improves survival. We first identified CD33+/CD11b+/HLA-DR-/low/CD14+/- as myeloid-derived suppressor cell (MDSC) surface markers by using flow cytometry to compare the MDSC frequency of OSCCs with blood samples from healthy donors (HDs). We then re-confirmed the suppression of T cell proliferation and function achieved by co-culturing with OSCC-educated MDSCs.

Clinically, we enrolled 100 OSCC patients and 30 HDs to demonstrate a significantly higher MDSC frequency in OSCC candidates than HDs. To determine whether using β-glucan as a food-grade supplement promotes the immune system of OSCC patients, we further allocated OSCC patients with and without pre-surgical administration of whole glucan particle β-glucan to groups II and III, respectively (with group I being the HDs).

We will explore whether using particulate β-glucan as a food-grade supplement promotes the human immune system via subversion of immune modulatory MDSCs. Lastly, we correlated clinicopathological parameters with MDSCs and β-glucan administration to examine anti-tumor immunity, and to predict the therapeutic effect and prognosis in OSCC patients.

Eligibility Criteria:
Inclusion Criteria:

* Oral squamous cell carcinoma (OSCC) subjects without other cancer diagnosis
* healthy donors (HDs)

Exclusion Criteria:

* pregnant woman
Efficacy of Light Therapy in Treatment of Chronic Cluster Headache

Cluster headache is a primary headache. The chronic form of the disease is often difficult to treat. It is now considered a chronobiological disease. This chronobiological character is based on clinical, biological and radiological arguments.

This study focuses on the use of light therapy in cluster headache. Light therapy has already been used in the treatment of other chronobiological diseases, such as seasonal depression, but also recently in the therapy of other primary headaches (such as migraine). Its aim is to re-adjust chronobiological rhythms, and it therefore seems worth testing in the chronic form of cluster headache.

Light therapy is delivered to the patient using a consumer electronics device.The main objective is to evaluate the prophylactic efficacy of light therapy in patients with chronic cluster headache.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, of 18 years years old or more;
* Diagnosis of chronic cluster headache according to ICHD-3 criteria;
* Number of seizures during baseline equal to at least 24;
* Stability of prophylactic treatment for at least 1 month and commitment not to change it for the duration of the study;
* Patient affiliated to the French social security system.
* Patient who understands and speaks French correctly;
* Patient who has given free and informed written consent.

Exclusion Criteria:

* Contraindication to the use of light therapy: use of a photosensitizing treatment;
* Ophthalmological history: cataract, macular degeneration, glaucoma, retinitis pigmentosa;
* Patients who work at night;
* Other neurological, psychiatric or developmental pathologies considered incompatible with the study;
* Background treatment of cluster headache with melatonin;
* Persons protected by articles L1121-5, L1121-6 and L1121-8 of the French Public Health Code (pregnant or breast-feeding women, persons deprived of their liberty by judicial decision, socially vulnerable persons, adults incapable or unable to express their consent).
Identification of Novel Genetic Factors That Contribute to Risk for Breast Cancer

The purpose of this study is to identify novel genetic factors which distinguish breast cancer in younger women compared to older women. By identifying these novel genetic factors we believe more specific therapies can be developed and breast cancer may be prevented among women with an increased cancer risk. A woman does not have to live in St. Louis to participate.

Breast cancer takes its greatest toll on younger women, as it is the leading category of cancer deaths for women 20-39 years of age. Sadly, survival rates are lowest among women diagnosed at a young age. This impact is most significant among African-American women who have the highest incidence and mortality rate among women less than 45 years of age. The goal of our program is to identify the genetic factors which distinguish breast cancer in younger women compared to older women.

Women who were diagnosed with invasive breast cancer 40 years of age or younger are invited to participate. The age at diagnosis is used to determine eligibility, not a woman's current age. Women who have undergone genetic testing of the BRCA1, BRCA2, p53, pTEN, e-cadherin, or LKB1 genes are eligible to participate. Young women with breast cancer are asked to: sign a consent form, submit a sample of blood, release their cancer related records, and answer some family history questions.

We will use a family based case control approach in our analysis. As such, if a woman's parents are living, they will be invited to participate as a "comparison" group. The parents are asked to: sign a consent form, submit a sample of blood, and release any cancer records.

A woman does not have to live in St. Louis to participate. All study related materials can be mailed directly to the young woman or her parents. There is no expense to the family. All materials are kept strictly confidential and participation is completely voluntary.

Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with invasive breast cancer 40 years of age or younger. If their parents are living, the parents are also invited to participate, regardless of their history of cancer.

Exclusion Criteria:

* Women diagnosed with in-situ breast cancer.
Diagnostic Performance of Positron Emission Mammography in Breast Cancer

Investigate the accuracy of PEM in detection of breast cancer.

Investigate the accuracy of positron emission mammography as non invasive method for early detection of breast cancer especially small sized cancers.

Eligibility Criteria:
Inclusion Criteria:

* patients suspected with breast cancer.

Exclusion Criteria:

* patient with glucose level \>200 mg/dl.
* Pregnant patients
Characterization of Thyroid Nodules Using Contrast Enhanced Ultrasound

This study will evaluate thyroid nodules using specialized ultrasound imaging methods.


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients diagnosed with a thyroid nodule 2. Age greater than or equal to 19 years of age 3. Patients must sign informed consent

Exclusion Criteria:

* 1. Women who are pregnant or nursing 2. Patients with pulmonary hypertension, unstable cardiopulmonary condition,or right to left shunt 3. Hypersensitivity to perfluten 4. Psychological condition that renders the patient unable to understand the informed consent
Fragility Re-fractures Prediction Score

Fragility fractures increase among elderly patients worldwide, representing a global burden in terms of disability and care expenditure.

Osteoporosis is asymptomatic up to the moment in which a first fracture occurs, reason why it is often underdiagnosed. Even after that, further fractures do occurr, as osteoporosis is often untreated. Several programs have been introduced worldwide to prevent secondary fractures among the population at risk (e.g., International Osteoporosis Foundation's Capture the Fracture), and several risk factors are being investigated to generate a predictive score. However, accurate validation is needed to make these scores reliable.

In this retrospective observational study, we aim to validate a predictive score trained on a population of elderly patients with a cohort of patients who underwent hip fracture surgery in a high-volume orthopedic center in the Region of Lombardy.


Eligibility Criteria:
Inclusion Criteria:

* People who underwent total or partial hip replacement (ICD 9 CM 81.51, 81.52) in five years (2013-2017) at the hospital for a compound fracture of the hip (ICD 9 CM 820, 820.01-820.09).

Exclusion Criteria:

* People undergoing the same intervention for other reasons (e.g. pathological fracture, ICD 9 CM 733.14).

ICD 9 CM stands for International Classification of Disease, 9th Revision, Clinical Modification.
The Effects of Walnuts, Walnut-Oil, Almonds and Fish Oils on Glucose Homeostasis in Polycystic Ovary Syndrome

The purpose of this study is to learn more about the effects of walnuts, walnut-oil, almonds and fish oils on blood sugar and insulin levels in polycystic ovary syndrome (PCOS) patients. The hypothesis is that a diet rich in these foods will improve insulin resistance in women with PCOS.

Polycystic ovary syndrome is a common disease that affects 1 out of 16 women. Metabolic and endocrine abnormalities seen in PCOS include insulin resistance, androgen excess and infertility. This study focuses on the insulin resistance aspect because increased insulin resistance leads to premature onset of impaired glucose tolerance or diabetes whereas decreased insulin resistance reduces androgen excess, improves the ovarian function and increases fertility. Although insulin resistance can be treated with insulin-sensitizing drugs, PCOS clinically manifests during adolescence and the long-term safety of the drug-treatment can be a concern. Thus, improving insulin resistance with effective nutritional approaches would be very desirable. Epidemiological studies and animal experiments suggest that replacement of dietary saturated fats with monounsaturated (MUFA) and polyunsaturated (PUFA) fats improves insulin resistance.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of polycystic ovary syndrome
* Body mass index (BMI) 22-52

Exclusion Criteria:

* Habitual dietary intake of less than 30% fat
* Use of oral contraceptives, insulin sensitizers, d-chiro inositol, or any other supplements affecting weight or insulin sensitivity during the preceding two months
* Impaired glucose tolerance
* Diabetes mellitus
* Other system illnesses such as renal, hepatic, gastrointestinal, severe hyperlipidemia and hypertension that require medication
* Smoking, alcohol intake (more than 2 drinks/week)
* The laboratory values used for exclusion of subjects will be fasting glucose \> 110 mg/dl, glycosylated hemoglobin (HgBA1) \> 6.5%, serum creatinine \> 1.5 mg/dl, ALT or AST \> 2x the upper limit of normal, cholesterol \> 250 mg/dl. The investigators will also exclude subjects with hematocrit \< 30%.
Hypofractionated Radiotherapy for Localized Prostate Cancer (With CyberKnife or With IMRT)

To demonstrate that a hypo-fractionated course of radiotherapy (ie. an accelerated radiotherapy course where fewer but larger doses of radiotherapy are given) is both safe and effective in the treatment of low-risk localized prostate cancer.


Eligibility Criteria:
Inclusion Criteria:- Eligible patients will have clinical stage T1c through T2b, initial PSA level \<10 and a biopsy Gleason score of 3+3 or 3+4 with fewer than 50% of biopsy cores involved.

* Patients who have had any form of prior curative treatment (surgery, radiotherapy, cryotherapy) will not be eligible. A prior course of hormone therapy of less than 3 months duration will be allowed.
* Adult men will be considered.
* No life expectancy restrictions will apply.
* Performance Status will not be considered.
* No requirements for organ or marrow function will be made
* Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria:- No prior prostate treatment will be allowed.
* The use of other concurrent Investigational Agents will not be allowed.
* No exclusion requirements due to co-morbid disease or incurrent illness.
* No requirements regarding history of allergic reactions.
* Pregnancy or nursing patients is not applicable (ie. patients are male).
Marijuana Treatment Project - 3

The goal of this research is to improve treatment outcome for marijuana-dependent individuals. The current study builds on the findings of our prior NIDA-funded marijuana treatment study in which improved client outcomes were associated with greater treatment attendance, greater client self-efficacy, and greater use of coping skills. We will use a contingency management paradigm to provide tangible reinforcement for completing homework assignments that are designed to enhance coping skills. It is anticipated that this will result in greater homework compliance, leading to greater self-efficacy regarding one's ability to cope with high-risk situations. Improved self-efficacy will enhance the likelihood of employing coping skills in high-risk situations, thereby increasing the probability of achieving and maintaining abstinence.

Participants will receive an intervention combining one session of motivational enhancement therapy with eight sessions of cognitive-behavioral coping skills therapy (MET+CBT). A contingency management procedure will be added to this intervention, providing reinforcement for completion of homework, as verified by call-ins to an Interactive Voice Recording (IVR) system. Outcomes will be compared to an MET+CBT intervention in which reinforcement will be provided for marijuana-free urine specimens, and to a control group that receives Case Management. Recruitment of 234 marijuana-dependent participants will occur over a three-year period. They will be randomly assigned to one of the three 9-session interventions. Treatment will be individual, manualized, and provided on an outpatient basis. Pretreatment assessments will obtain baseline data; follow-up assessments at three-month intervals for one year will evaluate marijuana use outcomes, other drug or alcohol use, and psychosocial functioning. It is anticipated that the intervention in which completion of homework is reinforced will result in the best outcomes. The mechanisms by which the interventions result in behavior change will be the specific focus of attention in this study.

Eligibility Criteria:
Inclusion Criteria:

* Cannabis dependence
* Willing to accept random assignment to interventions

Exclusion Criteria:

* Current dependence on alcohol or other drugs
* Problems that require inpatient hospitalization
* Reading ability below fifth grade level
* Lack of reliable transportation to treatment
* Excessive commuting distance
Interview Study of Adult and Child Patients and Parents of Children with Swelling Due to Nephrotic Syndrome.

Researchers from the University of Michigan and Northwestern University are studying people's experiences with swelling caused by Nephrotic Syndrome. Interviews with patients (child and adult) and parents of young children will be conducted. The information collected from the interviews will be used to develop a survey to use when testing new medications for Nephrotic Syndrome.

Please consider participating in a 1-hour long interview with the Prepare-NS research study to discuss children and adults experiences with swelling.

This registration includes concept elicitation, analysis and creation of complementary survey measures focused on edema/fluid overload of nephrotic syndrome. The measures to be developed include an Observer Reported Outcome (ObsRO) and Patient Reported Outcome (PRO). The ObsRO and PRO substudies are Institutional Review Board (IRB) approved at release.

The researcher's goal is to produce core outcome sets of patient-rated and observer reported Fluid Overload (edema) measures that can be applied across the fluid overload severity continuum, fit to help drug development in this area.

Eligibility Criteria:
Criteria for the Observer Reported Outcomes (ObsRO) cohort of the study:

Inclusion Criteria:

1. Parents/guardians must be able to read and understand English;
2. Parents/guardians must be caring for a child (ages 2-11.999) with a medically documented diagnosis of idiopathic (primary) Nephrotic Syndrome (NS) or primary or monogenic NS associated kidney disease. Populations with Primary NS Conditions: Focal segmental glomerulosclerosis (FSGS), Minimal Change Disease (MCD), Immunoglobulin M (IgM) Nephropathy, Membranous Nephropathy (MN), and childhood - onset nephrotic syndrome not biopsied;
3. The child must have a current NS-associated edema
4. The child must have native kidney function
5. Parents/guardians must provide informed consent.

Exclusion Criteria:

1. Index case with dialysis dependence throughout the 3-month pre-enrollment period

Criteria for the Patient Reported Outcomes (PRO) cohort of the study:

Inclusion Criteria:

1. ≥8 years of age
2. Able to read and understand English
3. Primary (idiopathic) kidney disease that causes NS or monogenic NS associated kidney disease.

   i. Populations with Primary Nephrotic Syndrome (NS) Conditions include: FSGS, MCD, IgM nephropathy, MN, and childhood - onset nephrotic syndrome not biopsied
4. Current NS-associated edema
5. Kidney function with most recent estimated Glomerular Filtration Rate (eGFR) \> 25 ml/min/1.73m2
6. Informed Consent: For patients ≥8 to \<18 years of age: a parent or legal guardian provide informed consent and the patient must provide assent. Patients ≥18 years of age must provide informed consent.

Exclusion Criteria:

1. Native kidney disease participant with dialysis dependence during the 3-month pre-enrollment period
2. Co-existing significant chronic or severe acute health condition that has the potential to influence how the participant feels or functions as related to fluid overload in NS
Silver Alloyed Urinary Catheters and Incidence of Catheter Acquired Urinary Tract Infections (UTI)

This study is a single blinded (Outcome Assessors), multicenter randomized controlled study designed to investigate if a silver alloyed urinary catheter with antibacterial properties can reduce the incidence of catheter acquired urinary tract infections in patients undergoing elective surgery. Patients requiring urinary catheterization will be randomized into two groups and receive either the silver alloyed catheter (test) or a silicone catheter (control).


Eligibility Criteria:
Inclusion Criteria:

* Adults in elective surgery requiring urinary catheterization

Exclusion Criteria:

* Patients who has or recently (within 3 weeks) had a urinary catheter
* Signs of urinary tracts infection
* Previous radiation therapy in lower pelvis
* Latex allergy
* Cognitive impaired
* Do not understand Swedish language.
Evaluating the Efficacy of Vardenafil in Subjects With Erectile Dysfunction (ED) Administered 12, 18 or 24 Hours Prior to Intercourse

Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. However, there remains no prospectively obtained data on the maximal time of effectiveness of vardenafil. The goal of the current study was to determine if vardenafil will significantly increase the percentage of successful intercourse attempts from 12 to 24 hours following dosing. A total of three time points 12, 18, and 24 hours were assessed in this pilot study to better quantify the effect of vardenafil.


Eligibility Criteria:
Inclusion Criteria:

* Men \>/= 18 years of age
* ED \>/= 6 months
* Stable sexual relationship for \> 6 months

Exclusion Criteria:

* Primary hypoactive sexual desire
* History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
* Nitrate therapy
* Other exclusion criteria apply according to the Summary of Product Characteristics
Maternal and Perinatal Outcome in Women With History of Premature Labor in Previous Pregnancy

Introduction: Preterm labor (PTL) is an important obstetric intercurrence that affects 5 to 10% of pregnancies. Among the known factors of PTL etiology are PTL occurrence in previous pregnancies, multiple pregnancies, polyhydramnios, vaginal bleeding during pregnancy, premature membrane rupture (PMR) and bacterial vaginosis. Despite the advancement achieved in Neonatology, morbidity and mortality resulting from high rates of preterm births have remained constant in the last few decades. Objective: This study aims at evaluating maternal and perinatal outcomes of pregnant women with a history of preterm labor in previous pregnancies and submitted to active search for vaginal infection. Material and Method: It is a prospective-cohort epidemiological study to be conducted in Botucatu/SP. Two study groups (G1 and G2) will be formed, and each of them will comprise 140 pregnant women with a history of preterm childbirth. G1 will be related to the active search and etiological diagnosis of lower genital tract infections, and G2 will be related to non-search for such infections, for which the routine care protocol of primary health units in the city of Botucatu will be maintained. Care propedeutics for the pregnant women (G1) will include the performance of direct examination of vaginal content stained by the Gram method, culture in Diamonds medium, polymerase chain reaction (PCR) of endocervical secretion collected in the primary health care services in the city at two moments: prior to the 20th gestational week (M1) and at the 36th week (M2). Moment M3 will take place after childbirth for evaluation of the perinatal outcome.


Eligibility Criteria:
Inclusion Criteria:

* Will be included in the study women with a history of preterm labor in previous pregnancy, without other risk factors identified in the initial prenatal current to initiate prenatal care until 20 weeks of gestation in any unit of primary care and Botucatu they have agreed to participate.

Exclusion Criteria:

* Will be excluded from the study women who have complications during pregnancy such as urinary tract infections, severe periodontal disease, hypertension, diabetes or multiple gestation, among others.
Investigating the Plasticity of Human Predictive Coding Through Neuromodulation

The hypothesis of the study is to investigate how different trm (tES) methods (transcranial Alternating Current Stimulation, tACS, and transcranial Random Noise Stimulation, tRNS) applied at different stimulation frequencies and networks can modulate the predictive mechanisms in human perception and cognition. This is an interventional, monocentric, cross-sectional randomized, single-blinded study on healthy adult volunteers, recruited through online advertisements, flyers and oral transmission. Volunteers will be recruited from the general population of young adults.


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Aged 18-35 years.
* Normal or corrected to normal vision, as per anamnestic investigation.

Exclusion Criteria:

* Participants with a diagnosis of epilepsy (as per anamnestic investigation).
* Participants with major neurological disorders (as per anamnestic investigation).
* Participants that are currently under psychopharmacological treatment with tricyclic antidepressants (as per anamnestic investigation).
* Participants with metal implants in the brain, pacemakers, brain stimulators, cochlear implants (as per anamnestic investigation).