cyrilzakka/clinical-trials huggingface dataset:
Six Week Study of Experimental Mouth Rinses: Effect on Gingivitis and Plaque

The purpose of this study is to evaluate the safety and efficacy of experimental mouth rinse formulations compared to a positive control mouth rinse and a hydroalcohol control mouth rinse for the reduction of gingivitis and plaque when used as an adjunct to tooth brushing during a six-week product usage period.


Eligibility Criteria:
Inclusion Criteria:

* Adequate oral hygiene (That is brush teeth daily and exhibit no signs or oral neglect)
* A minimum of 20 gradable teeth including 4 molars with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, teeth with veneers, or third molars will not be included in the tooth count
* A mean gingival index greater than or equal to (\>=) 1.95 per the Modified Gingival Index at Baseline (for those in the randomized treatment group)
* A mean gingival index less than or equals to (\<=) 0.75 per the Modified Gingival Index at Baseline (for those in the healthy reference group)
* A mean plaque index \>= 1.95 per the 6 site Turesky modification of the Quigley-Hein Plaque Index at Baseline (for those in randomized treatment groups)
* Greater than or equal to 10 percent (%) bleeding sites at baseline (for those in randomized treatment groups)

Exclusion Criteria:

* History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes, mouth rinses and red food dye
* Dental prophylaxis within four weeks prior to Screening/Baseline 1 visit
* More than three sites that have periodontal pockets depths measuring 5mm or greater in depth
* Teeth having periodontal pocket depths measuring more than 3 mm in depth (healthy reference group)
* History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
* Use of Antibiotics, anti-inflammatory or anticoagulant therapy, phenytoin sodium or diphenylhydantoin, calcium channel blockers, cyclosporin A, immunostimulants/ immunomodulators during the study or within the one month prior to the Baseline 1 exam. Intermittent use of certain anti-inflammatory medication is acceptable at the discretion of the Investigator
Neurocognitive Effects and Tolerability of Efavirenz in Aging HIV-infected Individuals ("SHAC Neuro Study")

Investigators hypothesize that older HIV-infected individuals (i.e., \>50 years old) on efavirenz (EFV)-containing antiretroviral therapy (ART) will have significantly worse neurocognitive function than older individuals on non-EFV-containing ART.

With the aging of the HIV-infected population in the United States and elsewhere, neurocognitive dysfunction will likely become an increasingly common problem. Older individuals could be at increased risk for efavirenz-associated adverse effects due to impaired metabolism, increased drug-drug interactions, and lower physiologic reserve, but there are few data on the long-term safety of efavirenz (and other antiretrovirals) in older individuals with HIV.

The Stanford HIV Aging Cohort (SHAC) is an ideal setting to study potential neurologic effects of antiretrovirals in aging patients. SHAC is an ongoing longitudinal study initiated in 2008 to evaluate aging in virologically-suppressed HIV-infected individuals. The cohort is supported through multiple grants including a grant from the State of California's HIV Research Program as well as a NIH supplemental grant. As of September 2013, approximately 150 virologically-suppressed HIV-infected adults have been enrolled. In addition to enrolling patients with good adherence to ART, the cohort purposefully excludes subjects with active substance abuse, unstable medical conditions, and psychiatric illnesses to limit potential confounding the study end points. Recently, an NIH supplemental grant (AI069556) was received which will expand the SHAC to 300 HIV-infected subjects. The median age of the subjects in the cohort is in the mid-50's allowing an ample number of older subjects for our planned studies.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment into SHAC (Stanford HIV Aging cohort)
* Age over 50 years of age
* Stable antiretroviral therapy containing EFV- or PI-containing ART (but not both) for at least 6 months
* HIV RNA levels of \<200 copies/mL for at least 6 months excluding blips (i.e., a single measurement between 200-500 copies/mL preceded and followed by measurements of \<200 copies/mL) while on ART.

Exclusion Criteria:

* Completed treatment for any acute systemic infection (other than HIV-1) less than four weeks before study entry
* Any active brain infection (except for HIV-1), brain neoplasm, or space-occupying brain lesion.
* Any active psychiatric illness including schizophrenia, severe depression, or severe bipolar affective disorder that, in the opinion of the investigator, could confound the analysis of the neuropsychological test results.
* Active drug or alcohol abuse that, in the investigator's opinion, could prevent compliance with study procedures or confound the analysis of study endpoints.
* Hospitalization within 30 days of study entry
* Receipt of systemic chemotherapy within 30 days of study entry
* Unable to provide informed consent
Development of a Multidisciplinary Network for Clinical and Laboratory Research for SMA

The goal of this observational study is to to establish profiles of clinical progression in patients affected by the different types of SMA (type I, II and III) treated with the currently approved drugs using a structured battery of clinical tests.

Another goal of the study is to assess the progression of the disease in patients identified through neonatal screening.

The collection of 2-year longitudinal clinical data will be conducted in newly treated patients at baseline, 6-, 12-, 14- and 22-months post-treatment. Parameters will include motor function, fatigability, respiratory function, event-free survival and death, and swallowing and feeding modalities. It is anticipated that at least 30 new patients will be enrolled in the study.

Importantly, information will also be collected on patients who may decide to switch treatment during the duration of our study, trying to establish if the switch to a new drug (or as an add-on should patients take a new treatment after being treated with gene therapy) may be associated with changes in clinical phenotype.

The aim is to apply a newly established clinical protocol that allows identifying minor signs of disease that are easily missed in the absence of an NBS-detected diagnosis. Indeed, not all infants identified as SMA-positive through the NBS are truly asymptomatic, as a proportion of them may appear paucisymptomatic and their minor signs could be possibly not detected in the absence of a positive screening test.

Eligibility Criteria:
Inclusion Criteria:

* All SMA patients

Exclusion Criteria:

* Inability to understand or to provide informed consent.
Comparison of Emergence and Oxygenation During One-lung Ventilation With Desflurane and Propofol Anesthesia

Which is more adequate general anesthetic agent, desflurane or propofol, for emergence and recovery time, and perioperative oxygenation in lung resection surgery?

The investigators plan to investigate the effects of desflurane on oxygenation (prevention of HPV) of OLV compare with propofol which is used in general anesthesia for lung resection.

Transesophageal echocardiography (TEE) wiill be used to measure pulmonary blood flow during surgery visible and successively. To confirm the effect of HPV by measuring the change in pulmonary blood flow. The correlation between the blood oxygen concentration and attenuation of blood flow will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Patients agree to participate in the study
* Patients undergoing lung cancer surgery requiring one-lung ventilation.
* American Society of Anesthesiologists Physical Status Class 1 or 2

Exclusion Criteria:

* Patients with any of the following will be excluded from lung cancer patients.
* New York Heart Association Classification more than 2
* Respiratory dysfunction Vital Capacity or percent predicted Forced expiratory volume in one second is less than 50 %
* Pulmonary hypertension with mean pulmonary arterial pressure more than 30 mmHg
* Coagulation dysfunction
* The administration of steroids and immunosuppressive agents within 3 months prior to surgery
* Infection with active inflammation
* Pneumonectomy patients
* Cases of epidural anesthesia is contraindicated
500mg Fulvestrant Versus Everolimus Plus Exemestane in MBC Patients Refractory to Previous AI

500mg Fulvestrant versus Everolimus plus Exemestane in MBC patients refractory to previous AI

Fulvestrant versus Everolimus plus Exemestane for patients with Metastatic Breast Cancer resistant to Aromatase Inhibitors: the clinical experience from real -world

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with ER/PR+，HER2- Metastatic Breast Cancer
2. Patients who were refractory to previous Aromatase Inhibitors
3. Patients treated with Fulvestrant or Everolimus plus Exemestane in any line in metastatic setting in Fudan University Shanghai Cancer Center，starting from 2013.06.01-2016.06.01
4. Available medical history

Exclusion Criteria:

1.Incomplete medical history
Comparative Trial to Investigate the Dose-Response of 4 Different Dose Levels of Minirin Melt and Placebo

This is a multi-centre, randomised, placebo-controlled, double-blind, parallel-group comparative trial to be conducted in nocturia patients. The trial is designed to characterize the dose-response relationship of Minirin (desmopressin) Melt in order to establish correct dose recommendations in the target patient population. In particular, the trial is designed to link the duration of action to the clinical endpoint. Furthermore, the trial is designed to describe the safety of four different dose levels of desmopressin.


Eligibility Criteria:
Inclusion Criteria:

* Given written informed consent prior to any trial-related activity is performed
* Aged 55-75 years
* Mean number of nocturnal voids of at least two per night
* Reached post-menopause (applicable to females only)

Exclusion Criteria:

* Evidence of bladder outlet obstruction (BOO); or a urine flow of less than 5 mL/s (applicable to males only)
* A surgical treatment for BOO or prostatic hyperplasia within the past 6 months (applicable to males only)
* Showing symptoms of any of the following diseases and having a mean number of nocturnal voids exceeding four per night: Benign prostatic hyperplasia, overactive bladder, interstitial cystitis, severe stress urinary incontinence
* Psychosomatic or habitual polydipsia
* Urinary retention; or a post void residual volume in excess of 150 mL
* A history or complication of urologic malignancy (e.g. bladder cancer or prostate cancer)
* Complication of genito-urinary pathology (e.g. infection, stone, or neoplasia)
* Complication of neurogenic detrusor activity
* Complication or suspicion of heart failure
* Uncontrolled hypertension
* Uncontrolled diabetes mellitus
* Complication of hepatobiliary disease
* Abnormal serum creatinine level
* Complication of hyponatraemia, or serum sodium level \<135 mEq/L
* Central or nephrogenic diabetes insipidus (CDI or NDI)
* Syndrome of inappropriate antidiuretic hormone (SIADH)
* Obstructive sleep apnea
* Alcohol dependency or drug abuse
* A job or lifestyle that may interfere with regular night-time sleep
* Previous desmopressin treatment
* Treatment with another investigational product within the past 3 months
* A need for treatment with a prohibited concomitant drug for a complication or other problem
* A mental condition, the lack of decision-making ability, dementia or a speech handicap
* Any other reason that the Investigator believes inappropriate
Antioxidant Supplementation in Pregnant Women With Low Antioxidant Status

The purpose of this study is to investigate antioxidants supplementation in pregnant women with low antioxidant status at 10-12 weeks gestation age in relation to adverse pregnancy outcome in randomized prospective study.

Preeclampsia still remains a leading cause of feto-maternal mortality and morbidity in developed and developing world. Despite of intensive research, the underlying pathologic mechanisms of this disease remain elusive. It has been agreed that incomplete or absent transformation of spiral arteries by replacing endothelial cells and mural vascular smooth muscle cells has been observed in the placental bed of preeclamptic patients and severe cases of intrauterine growth restriction. Oxidative stress has been proposed as a link between these mechanisms. However, it has been demonstrated by two large studies that antioxidant supplementation does not reduce the risk of preeclampsia. Our initial study has been shown that antioxidant supplementation may be reduce the risk of preeclampsia in pregnant women with low antioxidant status.

Comparison(s): adverse pregnancy outcome between vitamin C and E given and placebo given to pregnant women with low antioxidant status at 10-12 weeks gestation age

Eligibility Criteria:
Inclusion Criteria:

* Agree to consent form, and consent to protocol of research
* Known healthy singleton 6-10 weeks pregnant women

Exclusion Criteria:

* Blood pressure \> 135/85
* Proteinuria
* History or current use of anti-hypertensive medication or diuretics
* Use of vitamins C \> 150 mg and/or E \> 75 IU per day
* Pregestational diabetes
* Known placental abnormalities.
* Current pregnancy is a result of in vitro fertilization
* Regular use of platelet active drugs or non-steroidal anti-inflammatory drugs
* Known fetal abnormalities
* Documented uterine bleeding within a week of screening
* Uterine malformations
* History of medical complications
* Illicit drug or alcohol abuse during current pregnancy
* Intent to deliver elsewhere
* Known psychologic problems.
* Participating in another interventional study
Treatment of Conduct Problems and Depression

Having both depression and conduct problems at the same time has been found to be associated with increased risk for the other and increased risk of negative outcomes. This study will develop an family based cognitive behavioral treatment protocol for youths with both conduct problems and depression, that will take be administered over the course of six months. Youth with comorbid conduct problems and depression will be assigned to the experimental condition or treatment as usual in a community care setting. The treatment manual will be revised as needed. Youth will be assessed before and after treatment to examine program potential. The goal of this research is to develop a more comprehensive outpatient treatment for youth with both conduct problems and depression.


Eligibility Criteria:
Inclusion Criteria:

* 8-14 years old
* Diagnosis of ODD or CD
* Diagnosis of Depression
* Speaks English

Exclusion Criteria:

* Developmental/cognitive delays
* Substance dependence
* Psychotic disorder or symptoms
V Shaped Plate Vs Champy Technique in Mandibular Angle Fractures

assessing fixation of mandibular angle fracture using two different mini plates, the standard champy technique and the new V shaped plate with comparing occlusion and condylar position between the two plates.

The mandible is one of the most frequent bones of the face that is susceptible to fractures because its prominent position, as it comes in the second place after nasal fractures . Mostly, such fractures are a result of trauma caused by vehicle accidents, physical altercations, industrial accidents, falls, and contact sports, males usually suffer from mandibular fractures more than females.

The angle of the mandible is the most frequent area of the mandible to be fractured after the body, the reasons behind that is the presence of a third molar especially if it was impacted one which weakens the region even more, another reason is the existence of a very thin cross sectional area compared to the anterior parts of the mandible. Most common causes of mandibular angle fractures are motor vehicle collisions and assaults or altercations.

Therefore, the aim of this study is to evaluate a novel method which is using a (v) shaped plate in fixation of mandibular angle fracture, The new (v) shaped plate have provided easy reduction and stabilized fixation along both sides of the fracture, as it has two arms that can be easily adjusted over the angle of the mandible covering both lines of osteosynthesis along the superior border and lateral surface of the external oblique ridge using a single plate.

Although champy technique has been proven to be successful way for treating angle fractures with low complication rates it covers only one line of osteosynthesis which is the superior border of external oblique ridge unlike the (v) shaped plate.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with unilateral angle fracture.
2. Patients free from any systemic diseases that affect bone healing.
3. No sex predilection.
4. Age 18-50

Exclusion criteria:

1. Comminuted angle fractures.
2. Infected angle fracture.
3. Bilateral angle fracture.
4. Patients with any systemic diseases that affect bone healing.
Engaging Homeless Youth in Vocational Training to Meet Their Mental Health Needs

This randomized controlled trial (RCT) compared the efficacy between the Social Enterprise Intervention (SEI) and Individual Placement and Support (IPS) with homeless youth with mental illness.

Methods: Non-probability quota sampling sampling was used to recruit 72 homeless youth from one agency, who were randomized to the SEI (n=36) or IPS (n=36) conditions.

In response to the limited use of RCTs with homeless youth to test research-supported interventions, this study compares the efficacy and short-term outcomes of two interventions that combine employment and clinical services with homeless youth experiencing mental illness. The Social Enterprise Intervention (SEI) is a research-supported intervention using a group approach that engages homeless youth in paid employment as well as case-management and mental health services through involvement in an agency-run social enterprise. The Individual Placement and Support (IPS) model of supported employment is an individually focused, evidence-based intervention , which provides individuals with severe mental illness with customized, long-term, and integrated vocational, case-management, and clinical services to help them gain and maintain competitive employment.

A randomized comparative efficacy trial of the short-term, nonvocational outcomes (depression, self-esteem, social support, housing stability) of the SEI and IPS was conducted over 20 months with 72 homeless youth at a homeless youth drop-in center in Los Angeles. This study answered two research questions: 1) Do homeless youth with mental illness participating in an employment intervention integrated with clinical services (SEI or IPS) experience improvements in their a) mental health status (self-esteem and depression); b) housing stability, and c) social support; and 2) What are the differences between the SEI and IPS groups on mental health, housing stability, and social support outcomes between baseline and follow-up?

Eligibility Criteria:
Inclusion Criteria:

* Age 16-24
* English speaking
* Primary clinical diagnosis in the past year (with at least one symptom in the past 4 weeks) using the DISC-Y interview for one of six mental illnesses (i.e., Major Depressive Episode, Mania/ Hypomania, Generalized Anxiety, Post-traumatic Stress Disorder, Conduct Disorder, and Alcohol/Substance Use Disorders
* Desire to work.

Exclusion Criteria:

* None
The Impact of Conventional Hemodialysis and Renal Transplantation on the Global Longitudinal Strain of the Left Ventricle

The objective of this study is to evaluate a group of patients with chronic kidney disease in stages 3-5 by conventional 2D echocardiography, tissue Doppler techniques and speckle tracking - LV GLS and determine the correlation of ultrasound parameters with mortality. Additionally, fibrosis-related biomarkers will be studied in this population.


Eligibility Criteria:
Inclusion Criteria:

* eGFR \< 15 ml/min/1.73m2 (CKD - EPI)
* NYHA class I-II
* Hemodynamic stability

Exclusion Criteria:

* age \< 18 years old
* poor acoustic window
* atrial fibrillation
* recent Acute Myocardial Infarction
* pacemaker
Adult-to-Adult Living Donor Liver Transplantation Study

There are two principal purposes of this study: 1) to determine whether it is more beneficial for a liver transplant recipient candidate to pursue a living donor liver transplant (LDLT) or wait for a deceased donor liver transplant (DDLT), and 2) to study the impact of liver donation on the donor's health and quality of life.

Adult to adult living donor liver transplantation (LDLT) is a relatively new procedure increasingly used at major transplantation centers. Relatively small numbers of cases are performed at any one center and approaches to the patient and donor are too diverse across centers to provide reliable and generalizable information on donor and recipient outcomes from individual centers. Therefore, a network of nine leading liver transplantation centers and a data coordination center (DCC) has been organized to accrue and follow sufficient numbers of patients being considered for and undergoing LDLT to provide generalizable results from adequately powered studies. This network has established the Adult to Adult Living Donor Liver Transplantation Cohort Study (A2ALL) that will conduct both retrospective and prospective studies of LDLT.

The primary study objective is to analyze the effect of choosing to pursue living liver donation. The principal hypothesis is that pursuit of a living liver allograft leads to decreased pre-transplant morbidity and mortality and better long term outcomes for patients starting from the point at which listed patients have a potential donor evaluated (at least a history and physical examination). Emerging data suggest that LDLT provides an inferior graft because of reduced parenchymal mass and added technical complexity when compared to a whole liver used for DDLT. The magnitude of the disadvantage to the LDLT graft will be assessed by comparing results between LDLT and DDLT from the time of transplant. Finally, a careful and detailed series of studies of potential and actual living liver donors is included as a primary objective because of the tremendous importance of this issue to our understanding of the impact of the procedure.

Secondary objectives will address selected biological and clinical issues in transplantation structured around the comparison between DDLT and LDLT.

Eligibility Criteria:
Inclusion Criteria - Potential Recipients:

* Potential recipient listed for single organ (liver) transplantation
* Patient is eligible for LDLT
* Age ≥ 18 years old at the time of donor history and physical exam
* Indication for transplant: non-fulminant liver disease
* Potential donor scheduled for evaluation (history and physical examination) within four weeks

Inclusion Criteria - Potential Donors:

* Meet donor criteria of the transplant center
* Age \>= 18 years old at donation
* Be evaluated with a history and physical examination at the transplant center
* Potential donor's recipient listed for single organ (liver) transplantation