cyrilzakka/clinical-trials huggingface dataset:
Inflammatory Biomarkers in Saliva at Depression

The goal of this observational study is to evaluate the inflammatory saliva biomarkers in depression and gingivitis.

The main question will be ; Will there be an increase at salivary biomarkers with depression patients and is it associated with gingivitis?

Background: The neuroimmune regulation disorder in depression patients causes the progression of inflammatory periodontal disease. The present study was to evaluate the periodontal health status and the levels of Triggering receptor expressed on myeloid cells 1 (TREM-1), peptidoglycan recognition protein 1 (PGLYRP1) and interleukin-1 beta (IL-1β) in individuals diagnosed with depression and to compare these findings with those of systemically healthy individuals.

Methods: Forty-two depression patients were classified in two groups: depression with gingivitis (DG) and depression with periodontally healthy (DPH) patients. Additionally, 23 systemically and periodontally healthy (SPH) individuals were enrolled to the study. Periodontal parameters were recorded. Saliva samples were collected and salivary levels of TREM-1, PGLYRP1, IL-1β were measured using Enzyme-linked Immunosorbent Assay (ELISA) kits.

depression regardless of periodontal status.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were moderate in severity according to the test result, who had not started drug therapy yet and who had not received antidepressant medication in the last 12 months

Exclusion Criteria: Patients with

* psychotic disorders
* autism spectrum disorders
* other anxiety disorders
* bipolar disorder
* mental any organic mental disorder and
* smokers, substance users
The Effect of Dry Needling of the Gluteus Medius Muscle in Patients With Chronic Low Back Pain

The effectiveness of dry needling of the Gluteus Medius muscle in combination with active exercises will be examined compared with sham needling with active exercises in low back pain (LBP) patients.

Objectives: To examine if dry needling in combination with active physiotherapy is more effective in reducing pain and increase activity of daily living, range of motion and muscle strength in patients with chronic low back pain compared to sham dry needling in combination with active physiotherapy.

Methods: the study will include individuals with non-specific LBP over 3 months.

Subjects will be divided randomly into two research groups, both will receive physiotherapy including mobility, strengthening and stretching exercises. Intervention group, additionally to exercises, will receive dry needling to the Gluteus Medius muscle by inserting a needle to a trigger point until a visible involuntary twitch in the muscle appears. Sham needling will be applied by needling with pre-cut and smoothed needles that will not penetrate the skin.

Both groups will receive two treatments per week and up to six treatments overall, evaluation will be performed before and after the series of treatments.

Eligibility Criteria:
Inclusion Criteria:

* Main complaint of nonspecific LBP over a 3 month period
* VAS \> 3 at baseline

Exclusion Criteria:

* two or more of the following signs are present on physical examination: lower extremity weakness in a myotome distribution, decreased sensation in a dermatomal distribution, altered lower extremity deep tendon reflexes, pathological reflexes, a positive straight leg raise (SLR) test, crossed SLR or femoral nerve stretch test.
* Symptoms began immediately after a significant trauma (motor vehicle accident, fall from a height) and subjects were not been screened for possible fractures.
* Physical therapy or chiropractic treatment for LBP was provided during the 6 months prior to participation in the study or are currently being treated.
* presence of contraindication for dry needling
* pregnancy
* past back or pelvic surgery
Effectiveness of Family Group Interventions for People With Schizophrenia

The mutual support group intervention would significantly improve the families' burden of care, functioning and social support, reduce the patients' severity of symptoms and re-hospitalizations, and reduce the demands for utilization of family services, when compared with the standard care group.

Family interventions in schizophrenia have shown positive effects on patients but little attention has been paid to their effects on family members, particularly those in non-Western countries. This multi-site randomized controlled trial evaluated the effectiveness of a bi-weekly, 12-session, family-led mutual support group for Chinese caregivers of schizophrenia sufferers over 36 months, compared with a family psychoeducation group program and standard psychiatric care. It was conducted with 114 families of outpatients with schizophrenia in Hong Kong of whom 38 were assigned randomly to a mutual support group, a psychoeducation group, or standard care. Families' psychosocial health status and patients' symptom severity and length of re-hospitalizations at recruitment, one-month, 18-month, and 36-month post-intervention were compared between groups.

Eligibility Criteria:
Inclusion Criteria:

* family caregivers lived with and cared for one family member diagnosed with schizophrenia according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV; American Psychiatric Association, 1994)
* family caregivers were at least 18 years of age and could understand and read the Chinese (Mandarin) language; and
* family caregivers were free from any mental illness themselves.

Exclusion Criteria:

* the patients with schizophrenia suffered no co-morbidity due to other mental illness during recruitment to the study
* family caregivers cared for more than one family member with mental or chronic physical illness; and/or
* family caregivers had been the primary carers for less than three months
Internet-based Cognitive Behaviour Therapy (CBT) for Persons Diagnosed With Bipolar II

The aim of the study is to test the feasibility and acceptability of internet-based Cognitive Behaviour Therapy (CBT) for persons diagnosed with bipolar disorder, type II. The idea is to treat residual depressive symptoms as well as using psychoeducation to improve their prognosis. Each participant will have a personal therapist that will provide guidance and support throughout the treatment.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of bipolar disorder type II
* Mild to moderate depressive symptoms
* 18 years of age
* Stable medication with a mood stabiliser
* Access to the internet

Exclusion Criteria:

* Diagnosis of psychosis
* Having received psychiatric in-patient care during the past year
* Ongoing psychotherapy
* Previous manic episode
* Previous suicide attempt
* Previous parasuicidal behavior documented in patient record (e.g. self-injury)
A Phase Ib Expansion Study Investigating the Safety, Efficacy, and Pharmacokinetics of Intravenous CUDC-101 in Subjects With Advanced Head and Neck, Gastric, Breast, Liver and Non-small Cell Lung Cancer Tumors

This is a phase Ib open label, expansion study of CUDC-101 in patients with advanced head and neck, gastric, breast, liver, and non-small cell lung cancer tumors. CUDC-101 is a multi-targeted agent designed to inhibit epidermal growth factor receptor (EGFR), human epidermal growth factor receptor Type 2 (Her2) and histone deacetylase (HDAC). The study is designed to compare the safety and tolerability of CUDC-101 when administered at the maximum tolerated dose on either a 5 days/week schedule or a 3 days/week schedule.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with histopathologically confirmed diagnosis of advanced breast, gastric, head and neck, liver and non-small cell lung cancer.

  * For subjects with non-small cell lung cancer only:

    * Most recent treatment must be erlotinib and subjects must have had a radiographic partial or complete response to treatment as defined by RECIST criteria and should be currently progressing after the documented response.
    * A documented mutation in EGFR exons 19 or 21
* Subjects must have no further standard of care options or have refused standard therapy
* Measurable or evaluable disease
* Age ≥ 18 years
* ECOG performance \< 2
* Life expectancy ≥ 3 months
* If female, neither pregnant or lactating
* If of child bearing potential, must use adequate birth control
* Absolute neutrophil count ≥ 1,500/µL; platelets ≥ 100,000/µL;
* Creatinine ≤ 1.5x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60mL/min/1.73m2
* Total bilirubin ≤ 1.5x ULN; AST/ALT ≤ 2.5x ULN. In subjects with documented liver metastases, the AST/ALT may be ≤ 5x ULN
* Prothrombin time ≤1.5x ULN, unless receiving therapeutic anticoagulation
* Serum magnesium and potassium within normal limits (may use supplements to achieve normal values)
* Subjects with brain metastases are eligible if controlled on a stable dose ≤ 10mg prednisone/day or its equivalent dose of steroids
* Able to render informed consent and to follow protocol requirements.

Exclusion Criteria:

* Anticancer therapy within 4 weeks of study entry.
* Use of investigational agent(s) within 30 days of study entry
* History of cardiac disease with a New York Heart Association (NYHA) Class II or greater congestive heart failure (CHF), myocardial infarction (MI) or unstable angina in the past 6 months prior to Day 1 of treatment, serious arrhythmias requiring medication for treatment.
* Known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C. Subjects with liver cancer and hepatitis may be eligible.
Influence of the Environmental Context on Neuro-psychomotor Development in Adopted Children

The neuro-psychomotor development of children is influenced by multiple factors that play a crucial role in determining normal development or the onset of difficulties and atypicalities. Among these, the environmental context plays a fundamentally relevant role in modulating the child's abilities. Previous studies have compared children who have lived in foster care for at least 8 months with children who have always been within their own family nucleus, highlighting deficits in growth, development, and cognitive and behavioral skills in the former.

The aim of this project is to assess the effect of the environmental context on the development of executive functions and adaptive abilities in adopted children. Executive functions involve cognitive processes such as initiation, planning, organization, and regulation of behavior, while adaptive abilities include skills that allow the child to respond to demands from the external environment.

The project is conducted in two phases: a retrospective and a parallel prospective phase. The retrospective phase involves the analysis of the clinical records of adopted children in school age at the Pediatric, Child Neuropsychiatry, and Clinical Psychology units of the Fondazione Policlinico A. Gemelli IRCCS. The prospective phase consists of evaluating executive functions and adaptive abilities using specific tools recommended by the Italian Society of Child Neuropsychiatry, including the Vineland Adaptive Behavior Scales for adaptive abilities and a series of specific tests for executive functions, included in the document "Assessment of attention and executive functions in developmental age: review of Italian instruments and proposal of a battery for in-depth analysis." Additionally, to assess internalizing or externalizing behavioral aspects, parents will complete the Child Behavior Checklist (CBCL) questionnaire.

Through this study, the investigators aim to deepen the understanding of the role of the environmental context in the neuro-psychomotor development of adopted children, with particular attention to executive functions and adaptive abilities. The results obtained may provide valuable information for a better understanding of the underlying mechanisms and for the implementation of targeted interventions aimed at the optimal support of these children during their growth and development journey.


Eligibility Criteria:
Inclusion Criteria:

* Signing the informed consent
* Age between 6 and 10 years
* Adopted after the first year of life

Exclusion Criteria:

* Comorbidity with other pathologies
* Children adopted from birth
* Cognitive impairment (IQ\<85)
Asphyxia Associated Metabolite Biomarker Investigation 2

Follow-up of participants of AAMBI1 study at age of at least 2 years. AAMBI1(ClinicalTrials.gov ID: NCT03354208): Verification of biomarkers in a human population for their ability to diagnose the severity of neonatal asphyxia. These biomarkers linked to asphyxia have been identified in animal studies.

Follow-Up on neuro-developmental status of Study participants of AAMBI1. AAMBI1(ClinicalTrials.gov ID: NCT03354208): The aim of the study is to verify the application of combinations of several laboratory parameters in early postnatal blood samples, for identification of infants, who will suffer from early abnormal neonatal neurological outcome, in a population at risk. The population at risk is defined as term and late preterm (\>36 weeks of gestation) human infants following perinatal hypoxia-ischemia with or without postnatal resuscitation.

Eligibility Criteria:
Inclusion Criteria:

* Infants previously enrolled in the AAMBI1 study

Exclusion Criteria:

* Missing valid written informed parental consent
Exercise and Diet Restriction on Cardiovascular Function in Obese Children and Adolescents

Prevalence rates of childhood obesity have reached alarming levels. As childhood obesity may already be associated with serious comorbidities, obese adolescents are at significantly higher risk for obesity and increased morbidity and mortality during adulthood. Combined lifestyle interventions, which include regular physical activity and dietary restriction, have been shown to result in most significant improvements in cardiovascular function and their associated factors in the pediatric and adolescent population with obesity. The aim of this study is to investigate the effects of a combined exercise and diet intervention on cardiovascular function and their associated factors in obese children.

Sixty obese children and adolescents will complete a 6-week program of exercise and diet intervention. Thirty normal-weight children and adolescents will be recruited as control group. Clinical characteristics, body composition, blood biochemistry, and circulating irisin levels of the subjects will be measured before and after 6-week intervention. Endothelial function will be assessed by a flow-mediated dilation test. Circulating exosome-derived miRNAs, exercise-induced epigenetic modifications, circulating irisin levels irisin concentration in plasma and arterial stiffness as well as cardiac autonomic function will be investigated before and after the 6-week intervention. Fecal samples were collected before and after the 6-week intervention for analysis of the compositional and functional changes in the human gut microbiota.

Eligibility Criteria:
Inclusion Criteria:

1. Participants aged 7-17 years
2. Participants satisfied the obesity diagnosis criteria is based on "Body mass index reference standards for the screening of overweight and obesity in Chinese children and adolescents" released in 2004, with cut-off points of p(95) for obesity

Exclusion Criteria:

1. Metabolic disease
2. Gastrointestinal disease
3. Cardiac disease
4. Taking medications which affected energy expenditure
5. Losing weight in the past three months whether by diet, taking weight-loss medication or more physical exercise than normal
A 5 Year Follow-up on Newly Diagnosed Breast Cancer Patients

The purpose of this study is to provide the physicians with quality long term follow up data on subjects from the Breast Cancer Clinic and the Plastic Surgery Clinic who have been newly diagnosed with breast cancer and will receive treatment for the cancer at this facility. Over the last two decades many studies have been done concerning the quality of life after a mastectomy and/or reconstruction process. The majority of these studies only run for one year post reconstruction, some however, do include a two year follow up. The investigators are proposing a 5 year long term follow up study on subjects who will be diagnosed and treated here at the Breast Cancer Clinic and the Plastic Surgery Clinic. The investigators first questionnaire will be given prior to any treatment for breast cancer, giving us a baseline for the subject's current quality of life. At each successive year, the subject will be given another questionnaire with regards to their progression through the reconstructive process. At the end of 5 years, the subject will complete a final questionnaire. These questionnaires will deal with many areas of daily life functions; activities of daily living, anxiety, depression, social interactions, personal and sexual relationships.

Upon informed consent of subject, a baseline questionnaire will be completed by the subject. At years 1, 2, 3, and 4 follow up questionnaires will be sent for completion to the subject. At year 5 a final questionnaire will be sent to the subject for completion.After all subjects have completed the study, data will be sent to the Department of Biostatics for analysis.

Eligibility Criteria:
Inclusion Criteria:

Any female age 18 or over that has been diagnosed with breast cancer and has been treated and followed in the Breast Cancer Clinic and the Plastic Surgery Clinic is eligible for study participation.

Exclusion Criteria:

Any person not meeting these requirements will not be eligible for study participation.
Application of Transcranial Direct Current Stimulation (tDCS) in Patients With Chronic Pain After Spinal Cord Injury

The purpose of this study is to determine whether the novel treatment of transcranial direct current stimulation (tDCS) could decrease the pain perception of those with spinal cord injury.

We will also determine whether these changes are correlated with the clinical outcome (pain reduction).

The active tDCS stimulation sessions will be compared to sham stimulation.

More study details will be provided by Spaulding Rehabilitation Hospital.

Eligibility Criteria:
STUDY ELIGIBILITY CRITERIA (similar to the criteria of the Interstitial Cystitis Network)

1. Providing informed consent to participate in the study
2. 18 to 64 years old
3. with traumatic spinal cord injury (complete or incomplete) - for instance, due to fall, car accident or gun shot; (for spinal cord injury only)
4. stable chronic pain for at least the three preceding months(for spinal cord injury only)
5. score higher or equal to 4cm (0 cm= 'no pain' and 10cm='worst possible pain') on the Visual Analogue Scale (VAS) for pain perception at the baseline/start of the treatment(for spinal cord injury only)
6. refractoriness to drugs for pain relieve - such as tricyclic antidepressants, antiepileptic drugs and/or narcotics (pain resistant to at least 2 of these drugs supplied in adequate dosages for six months) (for spinal cord injury only)
7. pain is not attributable to other causes, such as peripheral inflammation.
8. No clinically significant or unstable medical or psychiatric disorder
9. No history of substance abuse
10. No neuropsychiatric comorbidity
11. No implanted devices for pain control, such as vagal or deep brain stimulators
12. No contraindications to tDCS:

    * metal in the head
    * implanted brain medical devices
13. No pregnancy
14. Eligible to MRI according to MRI screening checklist.
15. No use of ventilators
Genetic Variants and Non-genetic Variables and Postoperative Nausea and Vomiting

Prospective observational study to analyse the association of non-genetic variables as well as genetic variants of candidate genes with the incidence of postoperative nausea and vomiting (PONV).

Background

Surgery and anesthesia are related to unwanted adverse events, side effects and postoperative discomfort. Postoperative nausea and vomiting are frequent and the question arises which patient is at specific risk for these sequelae. Some predisposing factors for PONV are well described, e.g. female sex, non-smoking status and postoperative opioids. Some drugs used for anesthesia as well as surgery related variables might induce PONV.

In this prospective association study patient related variables, surgical and anesthesia related variables as well as genetic variants of several candidate genes will be investigated in a well-described patient cohort presenting for scheduled surgery.

Objective

The aim of this study is to investigate a possible association of non-genetic variables and genetic variants with PONV.

Methods

Prospective association study performed in patients recovering form elective surgery and anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Written informed consent
* Elective surgery

Exclusion Criteria

* No written informed consent
* Cognitive impairment
A Phase II Study to Evaluate the Efficacy of TKI258 for the Treatment of Patients With FGFR2 Mutated or Wild-type Advanced and/or Metastatic Endometrial Cancer

This is a prospective, multi-center, open-label, single-arm, non-randomized, Phase II study to evaluate the efficacy and safety of TKI258 as second-line therapy in patients with either FGFR2 mutated or wild-type advanced and/or metastatic endometrial cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed diagnosis of advanced and/or metastatic endometrial cancer with available tissue specimen (either archival tissue or fixed fresh biopsy)
* Female patients ≥ 18 years old
* Documented radiologically confirmed progression of disease after prior first-line treatment evidence of progressive disease
* ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2
* At least one measurable lesion as per RECIST

Exclusion Criteria:

* Previous treatment with an FGFR inhibitor
* More than one line of treatment for advanced or metastatic disease
* Patients with uterine sarcomas, adenosarcoma, and malignant Mullerian tumors
* Patients with isolated recurrences (vaginal, pelvic, or para-aortic) potentially curative with radiation therapy or surgery
* Known central nervous system (CNS) metastases
* Malignancy within 3 years of study enrollment Other protocol-defined inclusion/exclusion criteria may apply
Drug Interaction Study With a Potential Alzheimer's Disease Compound

The purpose of this study is to determine whether BMS-708163 will effect the pharmacokinetics of the commonly prescribed medicines midazolam, warfarin, caffeine,omeprazole and dextromethorphan


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects
* 18-45 yrs old inclusive

Exclusion Criteria:

* Women