cyrilzakka/clinical-trials huggingface dataset:
The Efficacy of Early Amniotomy for Induction of Labor

The purpose of this clinical trial is to investigate the efficacy of early amniotomy on reducing both the duration of labor and the frequency of dystocia in nulliparous women undergoing an induction of labor. This research project is a prospective, parallel clinical trial, in which subjects are randomized into one of two treatment groups: those who undergo early amniotomy and those who do not undergo early artificial rupture of the amniotic membranes.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age \> 37 weeks (using established National Institute of Child Health and Human Development \[NICHD\] dating criteria)
* Nulliparous (i.e., first term pregnancy)
* Admitted to the hospital for induction of labor
* Singleton pregnancy
* Fetal head applied to the cervix
* The ability to understand the requirements of the study, as determined by the study nurse

Exclusion Criteria:

* Premature rupture of amniotic membranes
* Cervical dilation \> 4 cm
* Vaginal bleeding
* Major fetal abnormalities that are known at time of admission
Upper Extremity Dysfunction Post Radial Percutaneous Coronary Intervention

Trans-Radial Percutaneous Coronary Intervention (TR-PCI) is rapidly becoming the gold standard. This is especially the case in primary Percutaneous Coronary Interventions (PCI), where most benefits of the radial approach, such as reduced major bleeding and mortality, can be expected. However there is very limited research available looking at the consequences of trans-radial access for upper extremity function.

The main objective of this study is to provide insight in the morbidity with regards to the upper extremity surrounding the radial access route in percutaneous coronary interventions. Secondary objectives are to provide insight in the consequences for functional status, factors influencing and financial costs of this morbidity, to identify subject who might benefit from early referral and treatment of this morbidity and to generate hypotheses for further clinical research into this matter.

The investigators hypothesis is that approximately 20% of the population will experience upper extremity dysfunction after TR-PCI.


Eligibility Criteria:
Inclusion Criteria:

* Presenting for TR-PCI at the study centre.
* The radial artery can be palpated and Doppler ultrasound examination of the radial artery shows non-occlusive flow.

Exclusion Criteria:

* Currently enrolled in another study that clinically interferes with this study and that has not passed the primary endpoint.
* The clinical condition prohibits or hinders informed consent and/or baseline examinations. E.g. cardiogenic shock and cardiopulmonary resuscitation or subconscious and semiconscious state,.
* Co-morbid condition(s) that could limit the subject's ability to participate in the study or to comply with follow-up requirements, or impact the scientific integrity of the study, e.g. loss of voluntary motor control of the studied extremities.
Establish Quantitative PCR to Measure Bacteria Load of the VRE Bacteremia

The investigators hypothesized that quantitative PCR can be used in VRE bacteremia outcome monitoring. Vancomycin-resistant enterococci (VRE) was first found in 1988 and has become an important healthcare-associated pathogen due to rapid spread, limited options for therapy and the possibility of transferring vancomycin resistance to more virulent pathogens. VRE infections not only contribute to more hospital cost and longer length of hospital stay, but also higher attributable mortality compared to those caused by vancomycin susceptible enterococci. Two different meta-analyses have shown that vancomycin resistance is an independent predictor of death among patients with enterococcal bloodstrem infections (BSIs). Despite this, few effective antibiotics are approved by the US Food and Drug Administration for the treatment of serious VRE infections. Though several studies have conducted to find the possible mortality predictors, but none has used bacterial load as a marker.

Schonheyder et al. have used semiquantitative culture, and demonstrate the relationship between high bacterial load and mortality. However, it may take more than two days before culture result available, and the sensitivity of culture is greatly affected by antimicrobial treatment. Real-time PCR has been demonstrate good performance in early detection of bacteremia, and theoretically is less affected by antimicrobial usage. However, using quantitative real-time PCR to quantify VRE in blood has not been explored, yet.

The objective of this study is to establish a quantitative method to measure the amounts of VRE in blood using the VRE specific van gene. And test the hypothesis that higher VRE load in blood results in higher mortality among patients with VRE BSIs.

Primers and probe of VRE Real-time PCR will be constructed first. The investigators will prospective enroll patient with VRE bacteremia. Clinical data and outcome will be monitored. Bacteria load of VRE bacteremia will be measured via established real-time PCR. The outcome and the association of bacteria load of VRE bacteremia will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* \>18 y/o
* VRE bacteremia
Longitudinal Evaluation of Gastric Emptying and Accommodation in Children With Dyspepsia

The purpose of this research is to further study the relationship between gastroparesis (GP) (a condition in which the stomach cannot empty itself of food in a normal fashion) and functional dyspepsia (FD) (frequent symptoms of indigestion that have no obvious cause).


Eligibility Criteria:
Inclusion Criteria:

* Able to complete the Pediatric Cardinal Symptoms Questionnaire
* Both parent and child must be able to speak and understand English or Spanish

Exclusion Criteria:

* Have global developmental delay, autism disorder, or psychosis
* Are nonverbal and/or illiterate
* Lack fluency in English or Spanish
* Have other GI comorbidities such as inflammatory bowel disease, celiac disease, eosinophilic esophagitis, peptic ulcer disease, GI malignancy, or gastroesophageal reflux disease responsive to medications (medical records will be reviewed to detect these exclusions)
* Have a history of surgical procedures that could have potentially affected their GI tract anatomy, such as fundoplication or Ladd's procedure.
* Healthy child presenting to their well child care visit must not report a history of dyspepsia, have a history of any gastrointestinal disease, or be taking any medication that can disturb the GI tract motility.
A Study to Evaluate AGN-151586 Intramuscular Injections in Adult Participants for Treatment of Glabellar Lines

Facial lines that develop from repeated facial expression, such as glabellar lines (GL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to evaluate the safety and efficacy of AGN-151586 compared to placebo in adult participants.

AGN-151586 is an investigational product being developed for the treatment of GL. In the first period, participants are randomly assigned to receive AGN-151586 or placebo. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. In the second period, all participants who meet retreatment criteria will receive open-label AGN-151586. Around 160 participants will be enrolled in the study at approximately 14 sites in China, Taiwan, and Japan.

Participants will receive either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1. Eligible participants may then receive AGN-151586 injections on Day 43 and will be followed for up to 6 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care due to multiple study visits. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Must have Moderate or severe glabellar lines (GL) at maximum frown as assessed by both the investigator and participant using the FWS-A at Screening and Baseline Day 1 visit. The investigator and participant ratings must match within a visit but do not have to match between Screening and Baseline Day 1.
* Must be in good health as per investigator's judgment based on medical history, physical examination, and vital sign measurements.

Exclusion Criteria:

* Uncontrolled systemic disease.
* Infection or dermatological condition at the treatment injection sites.
Study GSI-136 in Healthy Young and Healthy Elderly Subjects

This is a first-in-humans study of GSI-136, a drug being developed for the treatment of Alzheimer Disease. The main purpose of this study is to determine whether GSI-136 is safe and tolerable in healthy young and healthy elderly subjects. The amount of drug in the body and the effects of the drug on the body will also be evaluated at certain timepoints.


Eligibility Criteria:
\<Inclusion:

1. Men or women of nonchildbearing potential (WONCBP) aged 18 to 50 years or greater than 65 years, inclusive, at screening. WONCBP may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for greater than 1 year (with follicle-stimulating hormone \[FSH\] level greater than 38 mIU/mL) and must have a negative pregnancy test result within 48 hours before test article administration. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound scan. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after test article administration.
2. Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight greater than 50 kg.

3) The elderly subjects must be generally healthy, but may be enrolled with a stable, chronic illness, if it is well controlled and does not interfere with the primary objective of the study. Subjects may be included with clinically important deviations from normal limits in medical history, physical examination findings, vital sign measurements, 12-lead ECGs, or clinical laboratory test results that are associated with stable, chronic, and well-controlled medical conditions.

Exclusion:

1. Any history or presence of chronic respiratory disorder or disease including but not limited to asthma, sleep apnea, or chronic obstructive pulmonary disease (COPD).
2. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
3. Presence or history of thyroid disease, symptomatic vertigo, significant cardiac valvular disease, congestive heart failure, angina pectoris, significant cardiac arrhythmia, or seizures.
Supplementation of Eriocitrin in Intestinal Microbiota

Pre-diabetes is characterized by high plasma concentration of glucose and glycated hemoglobin and is the main risk factor for the development of type 2 diabetes. Several studies show that the intestinal microbiota is intimately linked to cardio-metabolic factors (type 2 diabetes, insulin resistance) when in situations of dysbiosis. Food is a key element for a healthy microbiota, focusing on the consumption of polyphenols that modulate the intestinal environment through its alteration and production of short chain fatty acids, and can thus be a way of reversing situations such as pre- diabetes and insulin resistance. The objective of the study will be to investigate whether chronic supplementation of eriocitrin alters the intestinal microbiota of pre-diabetic and insulin resistant individuals, reversing these situations. This will be done by supplementation of eriocitrin-containing capsules with different dosages in pre-diabetic and insulin resistant individuals. There will be 12 weeks of intervention, with faecal collections, anthropometric and dietary evaluation, and then will be made microbiological analysis to identify the intestinal microbiota and biochemical analysis before and after the intervention. For statistical analysis, normality and homogeneity test (Kolmogorov-Smirnov and Levine test respectively), T-test to compare baseline time between groups and repeated-measures ANOVA (two-way) were used to compare changes within and between groups.

Individuals of both sexes between 30 and 60 years of age who present fasting glycemia between 100 mg / dL (5,6 mmol / L) and 125 mg / dL (6,9 mmol / L) 50, or concentration of glycated hemoglobin between 5.7% (39 mmol / mole) and 6.4% (47 mmol / mole) 50, or glycemic concentrations in the oral glucose tolerance test between 140mg / dL (7.8 mmol / L) to 199mg / dL (11.0 mmol / L) 50. The study will also include insulin-resistant individuals: insulin above 25 uU / mL, or who present HOMA-IR score above 2.7.

Individuals using supplements (vitamins, bioflavonoids), pregnant women and those who practice intense physical exercise (\> 10h / week) will be excluded from the study.

The primary endpoint will be alteration of the microbiota with possible improvement of the glycemic profile, leading to the reversal of pre-diabetes and insulin resistance.

Eligibility Criteria:
Inclusion Criteria:

* 30-60 years
* Increased fasting blood glucose from 6.1 to 7.0 mmol / L or,
* Decreased glucose tolerance of 7 , 8 to 11.1 mmol / L or,
* Glycated hemoglobin with values between 5.7 and 6.4%

Exclusion Criteria:

* Use hypoglycemic, hypolipidemic drugs,
* Use dietary supplements (vitamins, minerals, bioflavonoids, prebiotics, probiotics or other bioactive compounds),
* Exercise intensely (more than 10 hours per week)
* History of cardiovascular diseases , diabetes mellitus, liver and kidney disease.
Brief Intervention to Reduce Injury in Minorities

The purpose of this study is to evaluate the effectiveness and ethnic differences of a brief alcohol intervention for injured patients.

Injuries are not isolated events or one time occurrences and injury has been identified as an important public health problem. Among the risk factors associated with injury and injury recidivism, the most widely recognized is alcohol use with approximately 50% of all injuries associated with alcohol. In general, alcohol use and drinking patterns vary by ethnicity, with frequent heavy drinking and associated problems more common among Blacks and Hispanics. Blacks, in general, suffer a disproportionate level of alcohol problems, despite having higher rates of abstention than Whites and Hispanics. Hispanics also generally suffer more alcohol-related problems than whites. Overall, injury recidivism is higher among poorer, minority populations and among individuals who abuse alcohol. The efficacy of brief alcohol interventions in the emergency care setting such as hospital emergency departments and trauma care centers is a relatively new area of research. Brief alcohol interventions appear to reduce alcohol intake and rates of injury following hospitalization; however, there is a need to evaluate the efficacy of these brief interventions in various ethnic groups. The proposed research involves a randomized controlled trial of a brief alcohol intervention based upon motivational interviewing and harm reduction to reduce alcohol consumption and injury following admission to an emergency room or trauma department for treatment of an injury. The primary aim of the proposed project is to determine the efficacy of this intervention as applied in the trauma care and emergency room setting among Whites, Blacks and Hispanics. The three outcomes of interest include:

1. alcohol consumption as measured by number of standard drinks consumed per week and
2. frequency of drinking five or more drinks per occasion engagement in injury related risk behaviors and
3. injury recidivism rates

It is hypothesized that the brief alcohol intervention will have a greater impact on alcohol consumption, injury related risk behaviors and injury recidivism among Whites than Blacks and Mexican Americans. In addition, it is hypothesized that the brief alcohol intervention will have less of an impact on alcohol consumption, injury related risk behaviors and injury recidivism among Mexican Americans born in the United States than among those born in Mexico after controlling for acculturation, acculturation stress and sociodemographic characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Admission for treatment of an injury
* Self identification of Black, White or Hispanic Ethnicity
* Age \> 17
* Screen positive for potential alcohol related injury based upon clinical indication of alcohol use prior to injury including positive blood alcohol concentration, self report of alcohol use prior to injury, heavy drinking or drinking beyond normal limits as defined by NIAAA

Exclusion Criteria:

* Glasgow Coma Score or GCS \< 14
* Admission for self inflicted injury
Escitalopram in Schizophrenia in OCD- Open Label Study

SSRI's has been demonstrated to be partially effective in schizophrenia and OCD. We therefore suggest that Escitalopram up to 20 mg /d in those patients could be effective in reducing obsessive compulsive symptomatology


Eligibility Criteria:
Inclusion Criteria:

* Patients who suffer from schizophrenia and OCD

Exclusion Criteria:

* Substance abuse,
* Serious medical condintions,
* Being on SSRI treatment
Effects of Macular Buckle Versus Vitrectomy on Macular Hole and Macular Detachment in Highly Myopic Eyes

Full-thickness macular Hole associated with macular detachment is a one of the maculopathies of high myopia. There is controversy in the primary treatment for this situation. This study will compare the effects of macular buckling versus vitrectomy in a cohort of highly myopic eyes with this situation.

A randomized, open label, single center study comparing the efficacy of macular muckle + gas injection versus internal limiting membrane peeling + gas tamponade on full-thickness macular hole associated with macular detachment in eyes with high myopia.

Eligibility Criteria:
Inclusion Criteria:

* axial length ≥ 26.5 mm or refractive error (spherical equivalent) ≥ 8.0 diopter
* full-thickness macular hole
* macular retinal detachment
* evidence of posterior staphyloma on clinical examination

Exclusion Criteria:

* macular detachment which extended to the peripheral retina (i.e., extension beyond the major vascular arcades in more than one quadrant)
* a history of vitrectomy or scleral buckling
* intraocular active hemorrhage or inflammation
* any media opacity which precluded imaging or clinical evaluation of the macula
BAY12-8039, iv/Oral Pulmonary Abscess/Aspiration Pneumonia

The purpose of this trial is to determine the efficacy and safety of Moxifloxacin in comparison to Sulbactam/Ampicillin in the treatment of pulmonary abscesses and aspiration pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged 18 years or above
* The primary diagnosis is community or hospital acquired primary pulmonary abscess or aspiration pneumonia, requiring initial parenteral treatment

Exclusion Criteria:

* Known hypersensitivity to fluoroquinolones and/or ß-lactams
* Patients with mechanical ventilation lasting more than 48 hours prior to enrollment, with poststenotic pneumonia, infarction pneumonia, pulmonary tuberculosis, lung abscess/pneumonia with concomitant endocarditis
Effects of a 0.03% CHX Mouth Rinse in Peri-implant Mucositis

Aim: To evaluate the efficacy of a 0.03% chlorhexidine (CHX) and 0.05% cetyl pyridinium chloride (CPC) mouth rinse, as an adjunct to professionally and patient-administered mechanical plaque removal, in the treatment of peri-implant mucositis.

Material and Methods: Patients displaying peri-implant mucositis in, at least, one implant were included in this randomized, double-blinded, clinical trial. Subjects received a conventional professional prophylaxis (at baseline and 6-month visits) and were instructed to regular oral hygiene practices and to rinse, twice daily, during one year, with a 0.03% CHX and 0.05% CPC mouth rinse, or a placebo. Clinical, radiographic and microbiological data were recorded at baseline, 6 and 12 months. Disease resolution was defined as the absence of bleeding on probing (BOP). Repeated measures ANOVA, Student-t and chi square tests were used.


Eligibility Criteria:
Inclusion Criteria:

* the presence of, at least, one dental implant with clinical signs of peri-implant mucositis, defined as gently bleeding on probing (BOP) and/or suppuration without progressive radiographic bone loss (after at least 1 year of functional loading)

Exclusion Criteria:

* untreated or recurrent periodontitis \[presence of nine or more sites with PD 5 mm and with full mouth bleeding score (FMBS) \> 25%\];
* implants affected by peri-implantitis, (BOP and/or suppuration and progressive radiographic bone loss);
* removable implant-retained prosthesis;
* history of intake of systemic antibiotics within the previous month or other chronic systemic medications that could interfere with the study outcomes;
* and women being pregnant or breast-feeding.
Gait and REM Sleep Behavior Disorder

Many people with idiopathic rapid eye movement (REM) sleep behavior disorder (RBD) have an underlying synucleinopathy, the most common of which are Parkinson's disease (PD) and Lewy body disease. Identifying additional abnormal clinical features may help in identifying those at greater risk of evolving to a more severe syndrome. Because gait disorders are common in the synucleinopathies, early abnormalities in gait in those with RBD could help in identifying those at increased risk of developing overt parkinsonism and/or cognitive impairment.

The investigators aim to identify subtle gait abnormalities in idiopathic RBD and to identify sensitive and early biomarkers:

1. to detect subtle gait disorders in pre-symptomatic stage of synucleinopathy and
2. to track their evolution in the parallel with the disease progression.

Main objective: In comparison with age and gender matched-controls, to identify in patients with RBD a larger reduction of gait velocity (and other abnormalities of spatio-temporal characteristics of gait) between a single (gait) and a dual-task (gait+cognitive task).

Secondary objective:

1. In comparison with age and gender matched-PD patients, to identify in patients with RBD a smaller reduction of gait velocity (and other abnormalities of spatio-temporal characteristics of gait) between a single (gait) and a dual-task (gait+cognitive task).
2. In patients with RBD to identify correlations between the spatio-temporal characteristics modifications of gait between a single (gait) and a dual-task (gait+cognitive task) and the percentage of REM without atonia - the dopamine transporter (DAT) density using FP-CIT single-photon emission computed tomography; the reduction of the olfactory discrimination and thresholds.
3. In patients with RBD to track the spatio-temporal characteristics evolution of gait over time (every 6 months for 2 years)


Eligibility Criteria:
Inclusion Criteria:

* Specific inclusion criteria for RBD patients - to reach the diagnosis criteria of RBD (International Classification of Sleep Disorders 2)
* Specific inclusion criteria for PD patients - to reach the diagnosis criteria of idiopathic PD (Queen Square Brain Bank) - Hoehn Yahr score ≤ 2

Exclusion Criteria:

* Specific exclusion criteria for RBD patients - diagnosis of PD - other pathology associated to RBD diagnosis - presence of antiparkinsonism medication
* Specific exclusion criteria for PD patients - clinical signs of parkinsonian syndrome- Mini Mental State Examination \< 24/30- gait disorder clinically observable
* Specific exclusion criteria for controls - neurological disease- gait disorder