cyrilzakka/clinical-trials huggingface dataset:
Impact of Periodontal Bacteria at Baseline on the Effectiveness of Periodontal Therapy

In light of the controversy that are already approved but that however still exists regarding the efficacy and influence of the protocols for the management of Periodontitis, the aim of this study was to evaluate, at 6 months follow-up, the post-treatment clinical parameters and immunological and gingival microbial profiles in patients with periodontitis, treated by either SRP in addition to full mouth scaling or quadrant scaling

This trial was conducted in accordance with the World Medical Association's Declaration of Helsinki of 1975, and reviewed in 2008. The local ethical committee of the University of Messina approved the study protocol and each patient was carefully informed about the possible inherent risks of the study and provided their informed written consent 102 patients, , aged 27 to 65 (mean age 44.2) were assessed for eligibility. In all subjects, subgingival plaque was acquired from 4 separate proximal sites at 180 days after therapy.

Eligibility Criteria:
Inclusion Criteria:

1. good condition of general health,
2. a minimum of 2 teeth for each quadrant with a Pocket Depth (PD) ranging from 4-6 mm,
3. no involvement of the furcation,
4. a minimum of a six teeth per quadrant, respectively.

Exclusion Criteria:

1. periodontal therapy during the last 12 months,
2. assumption of antibiotics during the last 6 months,
3. pregnancy,
4. any systemic condition which might affect the effects of the study treatment,
5. previous or current radiation or immunosuppressive therapies,
6. use of mouthwash containing antimicrobials during the previous 3 months,
7. no use of hormonal contraceptives,
8. medication by anti-inflammatory and immunosuppressive drugs,
9. previous history of hard-drinking,
10. smoking,
11. class II and III tooth mobility.
Effect of Turmeric on Diabetic Nephropathy

The purpose of this study is to investigate whether turmeric is effective in improvement of diabetic nephropathy and in decrease in the amount of proteinuria and cytokine levels.

Diabetic nephropathy is leading cause of ESRF that many therapy recommended for it. In this study, we investigate effect of turmeric on diabetic nephropathy, thus we selected diabetic nephropathy patients and divided them into 2 groups. One group received turmeric + ACE inhibitor + Angiotensin II receptor blocker (ARB) and the second group received only ACE inhibitor + ARB.

Eligibility Criteria:
Inclusion Criteria:

* diabetic nephropathy
* more than 300 mg proteinuria/day
* age more than 18 years old

Exclusion Criteria:

* DM type 1
Esthesioneuroblastoma: Outcomes After Treatment

The purpose of this study is to collect and organize data into a repository to gather relevant information for future research from patients diagnosed with a rare malignant sinonasal cancer called esthesioneuroblastoma (ENB) and are scheduled to undergo endonasal skull base surgery. Data being collected includes surgical data, demographics, disease presentation, MRI, CT, PET imaging, and post-operative assessments including pathology tests. After surgery, the investigators will collect chemotherapy and radiation data. Participants will also complete quality of life questionnaires at their follow-up visits.


Eligibility Criteria:
Inclusion Criteria:

* Between the age of 10-80 years
* Diagnosed with esthesioneuroblastoma

Exclusion Criteria:

* Refusal to participate
Optimizing Postoperative Recovery After Breast Reconstruction With Autologous Tissue (BestDIEP)

Women who have their breast reconstructed with autologous tissue seem to be more satisfied with their breast. However, autologous breast reconstruction entails a bigger operation, and the usage of more health care resources, than some other methods, such as implant-based techniques. The main objectives of the present study are to investigate if pre- peri- and postoperative protocols can be safely modified, so the operation demands less resources, while maintaining a low complication rate and a high patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Operated or will be operated with a DIEP flap in the department
* \>18 years of age

Exclusion Criteria:

* Inability to leave informed consent
* Inability to understand and speak Swedish (for the questionnaire)
Dietary Diversities: Exploring the Influence of Keto Diet and Intermittent Fasting on Oral Health and Salivary Inflammatory Biomarkers

This study aims to investigate the impact of short term, two distinct dietary interventions, namely the Keto diet and Intermittent Fasting on oral health by measuring the severity of:

* Periodontal diseases (Gingivitis).
* Oral health status (Plaque index). As well as measuring the impact of these different dietary pattern on the levels of C- Reactive Protein, IL-6, TNF-a in mean of inflammatory biomarkers as well as LL- 37 peptide as well as measuring salivary flow and ph.

Objectives of the study

1. Evaluate the impact of Keto diet and Intermittent Fasting on oral health among the Iraqi population.
2. Assess changes in inflammatory biomarkers within the study groups before and after the intervention period.
3. Compare the effects of Keto diet and Intermittent Fasting on oral health and inflammatory biomarkers between the two intervention groups.
4. Examine the variations in oral health and inflammatory biomarkers within each group by comparing the baseline (Iraqi diet) and post-intervention stages.
5. Investigate the influence of Keto diet and Intermittent Fasting on the levels of LL37, an antimicrobial peptide.


Eligibility Criteria:
Inclusion Criteria:

* Adults in good general health with a BMI in the range of 19-30 kg/m2 (overweight and obese cl I).
* Age 20-35 years.

Exclusion Criteria:

* low-carbohydrate nutrition already prior to the study.
* Impaired liver and renal function, kidney stones.
* Pregnancy or lactation period
* Diabetes mellitus and any fatty acid-metabolism disorders.
* Presence of systemic disease (diabetes, hypertension, cardiovascular disease) that may affect oral health.
* Medications that may affect periodontal health conditions.
* Use of anti-inflammatory and antibiotic drugs during the last month before the examination.
* Smoking.
* Use of dietary supplements.
* Wearing orthodontics or prosthodontics appliances.
RCT of At-Home tDCS for Depression in Pregnancy

This is a randomized, sham-controlled trial to determine whether treatment with transcranial direct current stimulation (tDCS) is superior to a sham condition at reducing the symptoms of depression in pregnant people with moderate to severe depression. The study aims to enrol 156 participants across all sites. Data collection occurs at baseline, immediately after treatment, every 4 weeks during pregnancy and 4-, 12-, 26- and 52-weeks postpartum

Transcranial direct current stimulation (tDCS) is a brain stimulation technique for the treatment of depression that has great potential for filling the gap in treatment options for moderate and severe depression in pregnancy. Participants are randomized 1:1 to active tDCS treatment or sham control. After at least one in-person training session with the research team, participants take the tDCS device home and self-administer 30-minute treatments 5 times per week, for 3 weeks, for a total of 15 sessions. Rater-administered and self-report outcomes are collected weekly during the 3-week active treatment phase, every 4 weeks during pregnancy, and at 4-, 12-, 26- and 52-weeks postpartum. A mixed methods process evaluation is embedded into the trial.

Eligibility Criteria:
Inclusion criteria:

1. Adult, ≥18 years of age
2. Singleton pregnancy, 12 to end of 32 weeks single gestation at randomization
3. In a major depressive episode (MDE) with at least moderate symptom severity (PHQ-9 ≥10 and confirmed using MINI International Neuropsychiatric Interview as MDE without psychotic features)
4. Assessed by a psychiatrist at one of the study recruitment sites during pregnancy, and offered the option of antidepressant medication for treatment but declined to use
5. No new treatments for depression (i.e. psychological or somatic) and no pharmacological treatment for depression in the 4 weeks prior to starting treatment

Exclusion criteria:

1. Active alcohol or substance use disorder in previous 12 months as assessed by GAIN-SS
2. Active suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
3. Bipolar disorder as assessed by MINI International Neuropsychiatric Interview
4. Schizophrenia or other psychotic disorder as assessed by MINI International Neuropsychiatric Interview
5. Major unstable or life-threatening medical illness (e.g. such as advanced cancer), pre-eclampsia/eclampsia in current pregnancy or neurologic illness or seizure history
6. Major congenital anomalies or major obstetrical complications in current pregnancy (determined by clinical PI/Co-I assessment)
7. Metal implants in cranium or any electrical implants
8. Benzodiazepine (except intermittent low-dose lorazepam no more than 2mg equivalent per day) or anticonvulsant use as these interfere with anodal tDCS
9. Visibly non-intact skin/rash on scalp areas at stimulation electrode sites
10. Unable to consent or complete study measures in English, or unable to complete depression in pregnancy workbook (the attention-control) in French or English
Thiopurine Methyltransferase Polymorphisms Evaluation

The purpose of the study is to determine the frequency of allelic variants in TPMT in the Hispanic population and to compare the frequency in the Hispanic population with the Caucasian Population.

Relatively few studies have been performed evaluating the variant allele frequencies in Spanish populations. To date, no studies evaluating the TPMT variant allele frequency in the Hispanic population have been reported. Hispanics are a growing part of the patient population treated in the United States. Characterization of the proportion of patients with variant genotypes in this population is important since Hispanic children represent a significant proportion of children being treated with thiopurines.

A single 3 cc heparinized blood sample will be obtained for TPMT genotyping. The sample will be obtained either simultaneously with a clinical sample, at the time of an otherwise medically indicated intravenous catheter placement or scavenged from excess blood remaining following clinical laboratory testing.

Eligibility Criteria:
Inclusion Criteria:

* All Hispanic children and adolescents diagnosed and treated at Texas Children's Cancer Center within the last 5 years for malignant diseases/cancer and non-malignant hematological disorders that necessitate chemotherapy
* All Hispanic children and adolescents who will be treated at Texas Children's Center for malignant diseases/cancer and non-malignant hematological disorders that will necessitate chemotherapy.

Exclusion Criteria:

* Any child or adolescent registering at Texas Children's Cancer Center and not requiring any form of therapy.
Body Movements Analysis During Sleep in Very Premature Infants

Sleep is a key factor for normal brain development of the newborn. However, it is poorly studied and little is known about its characterization, especially in premature infants. Body movements during sleep are easy to evaluate but studies on their relationship to normal sleep states are scarce and limited. This project aims to characterize body movements during sleep, assessed by electroencephalography, in very premature infants. Then, a correlation between body movements, sleep organization and neurodevelopmental outcome will be evaluated at 3 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Infants born between 26 and 32 weeks gestation

Exclusion Criteria:

* Genetic abnormality
* Neurological pathology such as intraventricular hemorrhage \> grade 2
* Any medication know for altering electroencephalography recording
Feasibility Testing a Meditation App for Professionals Working With Youth in the Legal System

This feasibility clinical trial aims to assess the feasibility of implementing a 1-month app-based meditation program with officers in the juvenile legal system and other professionals working directly with legal-involved youth.

Professionals working with legal-involved youth experience high levels of depression, anxiety, and workplace burnout. Mindfulness meditation targets emotion regulation-which appears to be a common mechanism underlying depression, anxiety, and burnout-and it can be effectively delivered via smartphone app. This project will assess the feasibility of implementing a 1-month app-based meditation program with officers and other professionals working with legal-involved youth in Cook County, which houses one of the nation's largest juvenile legal systems. The findings are intended to inform the development of a future, fully-powered hybrid effectiveness-implementation randomized controlled trial (RCT).

Eligibility Criteria:
Inclusion Criteria:

* Currently working with youth in the juvenile legal system or related juvenile services and programming
* English speaking
* Able to understand and provide consent
* At least 18 years old
* Have an Android or Apple smartphone
Two Inodilators Postsurgery in Neonates

Congenital heart defects are the most prevalent group of congenital malformations in newborns. Surgery-related low cardiac output syndrome (LCOS) could be one of the reason for the unfavourable outcome of this population. The early use of inodilators (INDs), specifically milrinone (MR), is proposed to reduce afterload and increase inotropism. Studies in the paediatric population appear to support a clinical usefulness of MR similar to that observed in adults. Levosimendan (LEVO) is a novel class IND developed for the treatment of heart failure. Experience with LEVO in paediatric patients is scarce. The purpose of this study was to systematically test the efficacy and safety of milrinone (MR) and levosimendan (LEVO) in newborns undergoing cardiovascular surgery with cardiopulmonary bypass (CPB). Given the uncertainty about LEVO pharmacokinetics in neonates, the study was designed as a pilot, phase I feasibility study.

Surgical repair is the primary therapy for congenital heart defects in the newborn. The neonatal cardiovascular system is at particular risk to develop the surgery-related low cardiac output syndrome (LCOS), thus vasoactive agents are routinely used in the postoperative management. Systematic research on the efficacy of these drugs is scarce in the newborn. As LCOS pathophysiology joints impaired myocardial contractility and the peripheral effects of ischemia/reperfusion injury on the endothelium, early use of inodilators (IND) are strongly recommended to reduce afterload and improve contractility. This study aims to test the equivalence in dose-dependent hemodynamic effects of 2 IND, Milrinone and Levosimendan, used early without loading dose in the preoperative period to prevent LCOS. By means of non-invasive technology the investigators will assess cardiac function (serial structural and functional echocardiography), the cerebral and peripheral perfusion and oxygenation (continuous near-infrared monitoring), cerebral function (continuous amplitude integrated EEG monitoring), will rule out CNS acquired lesions (serial transfontanelar echo-Doppler studies), and will follow up different biochemical markers of myocardial stress and apoptosis. Pharmacokinetic studies will be also performed.

Eligibility Criteria:
Inclusion Criteria:

* Newborns undergoing cardiovascular surgery who were in stable pre-operative haemodynamic condition
* Parental consent given

Exclusion Criteria:

* Parental consent refused
* Inodilators contraindicated
Biospecimen and Medical Data Collection and Tumor Biopsy in Creating Research Tissue Registry in Patients with Inflammatory or Invasive Breast Cancer

This trial studies the biospecimen and medical data collection in creating a research tissue registry in patients with inflammatory or invasive breast cancer. Collecting medical data and storing samples of blood, tissue, and stool from patients with inflammatory breast cancer to study in the laboratory may help doctors find better ways to treat and study inflammatory breast cancer in the future.

PRIMARY OBJECTIVES:

I. To prospectively collect tissue (including primary inflammatory breast cancer \[IBC\], ipsilateral nodal metastasis and/or distant metastasis \[if applicable\] obtained prior to primary systemic therapy and mastectomy/axillary dissection), serum, plasma, whole blood, clinical, and imaging data from patients with recently diagnosed inflammatory breast cancer (IBC), or highly suspicious for IBC, who have not received systemic therapy.

II. To collect paraffin tissue blocks or unstained slides (including primary, ipsilateral nodal metastasis and/or distant metastasis \[if applicable\] obtained prior to primary systemic therapy), mastectomy/axillary dissection tissue, serum, plasma, whole blood, clinical, and imaging data (if available) from patients with previously diagnosed inflammatory breast cancer (IBC), who have been treated or partially treated, but have not had mastectomy and are seeking further treatment in the IBC clinic at M. D. Anderson or participating cancer network sites.

III. To collect oral swab, skin and stool bacterial culture swab for microbiome analysis to compare patients with specific breast cancer subtype to report changes in flora during the course of treatment and correlated to toxicity.

OUTLINE:

Patients complete questionnaires and participate in interview over 30 minutes. Patients also undergo collection of medical data and blood, tissue, and stool samples.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical diagnosis of primary inflammatory breast cancer (IBC), second primary IBC, or highly suspicious for IBC (MD Anderson patients only).
* Histological diagnosis of invasive breast cancer, or highly suspicious for IBC (MD Anderson patients only) but pending breast cancer diagnosis.
* Be either newly diagnosed, or highly suspicious for IBC (MD Anderson patients only) \[Cohort I\] or have paraffin blocks or up to 20 unstained slides of each representative block(s) from the time of initial diagnosis of IBC(i.e. core biopsy and punch biopsy) and/or from mastectomy (Cohort II-MD Anderson patients only)
* Age \> 18 years
* Able to provide informed consent

Exclusion Criteria:
Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Endometriosis: Identification of Potential Relevant Biomarkers to Diagnose and Treat

Patients seen at the SLUCare Center for Endometriosis (including those with or without pain) undergoing laser excision surgery for known or suspected endometriosis will be recruited for the study.

Per the PI's standard surgical approach to endometriosis, all areas of abnormal peritoneum will be excised (removed).

After surgical excision has been performed, in order to provide standardized specimens for our research, a 3mm punch biopsy will be obtained from the excised peritoneum tissue. The 3 mm biopsy will be sent for research analysis, and the rest of the excised peritoneum tissue will be sent to histology (SSM) for evaluation and classification as having endometriosis or not. For each patient in the study, blood will also be collected to look for markers for endometriosis.

The study is investigator-initiated, prospective, comparative study. Laparoscopic surgery for endometriosis on patients presenting with pain, infertility or both will be performed by the principal investigator at St. Mary's Hospital. We will be collecting preoperative, operative and postoperative follow-up data on all patients recruited for this study based on comprehensive preoperative questionnaires, which includes data collection on pain scores (by VAS scales) and standardized QOL scales, and the 6-12 month follow questionnaire. The surgical approach in the treatment of endometriosis is by excision only, so that all lesions (abnormal areas of peritoneum) are excised resulting in tissue specimens that are classified at a histologic level, which is the gold standard way to diagnose the presence of endometriosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients seen at the Center for Endometriosis (including those with or without pain) who are undergoing excision surgery.
* Patients who are undergoing laser excision surgery for known or suspected endometriosis will be recruited for the study.
* Completed a preoperative questionnaire

Exclusion Criteria:

* prior bilateral salpingo-oophorectomy
* post natural menopause
Off-Label Use of Ribavirin in Management of Mucocutaneous Extrahepatic Manifestations of HCV Infection

This study will be conducted on 30 patients with mucocutaneous complaints and documented HCV infection. The study will be done at Tropical medicine department , Tanta university. It will be conducted between June2014 and November 2014.

The aim of the study is to assess efficacy of Ribavirin in the management of mucocutaneous extrahepatic manifestations of HCV infection.

Hepatitis C virus is a common cause of chronic liver disease worldwide and represent public health problem. The Egyptian Demographic Health Survey (EDHS), a cross sectional survey including hepatitis C virus (HCV) biomarkers, was conducted in 2008 on a large nationally representative sample. It estimated HCV prevalence among the 15-59 years age group to be 14.7% . Accordingly, Egypt has the highest HCV prevalence in the world.

Although HCV is a hepatotropic virus, in some patients the primary manifestations of infection occur outside the liver. There is a growing body of evidence to support the idea that HCV can replicate efficiently in extrahepatic tissues including the Peripheral blood mononuclear cells (PBMC). Autoimmune manifestations are common in patients chronically infected by HCV . These manifestations can be dominant, whereas the hepatic disease can be quiescent or mild. More recently, there has been growing interest in the relationship between HCV and Sjogren's syndrome (SS), rheumatoid arthritis (RA), and systemic lupus erythematosus (SLE).

Of those , this article is interested in cutaneous and mucous membrane manifestations where many reports have shown that cutaneous manifestations are often the first signs of chronic HCV infection and these are indicated in 20-40% of the patients presenting to the dermatology clinics, therefore dermatologists must be aware of skin disorders associated with viral infection. The most commonly encountered dermatological manifestations of HCV infection includes mixed cryoglobulinemia (MC), porphyria cutanea tarda (PCT), cutaneous and/or oral lichen planus (LP), urticaria, pruritus, thrombocytopenic purpura and cutaneous vasculitis. Although majority of skin manifestations of chronic HCV infection represent the clinical impression of autoimmune phenomena, however, precise pathogenesis of these extra-hepatic complications is not well understood.

The aim of the study is to assess efficacy of Ribavirin in the management of mucocutaneous extrahepatic manifestations of HCV infection

This study will be conducted on 30 patients with mucocutaneous complaints and documented HCV infection. The study will be done at Tropical medicine department , Tanta university. It will be conducted between June2014 and November 2014.

Eligibility Criteria:
Inclusion Criteria:

* Patients with evidence of HCV infection and mucocutaneous complaint and contraindicated to have standard antiviral therapy.

Exclusion Criteria:

* Hypersensitivity to Ribavirin
* Pregnant \& Lactating women
* Male partners of pregnant women