cyrilzakka/clinical-trials huggingface dataset:
The Value of Bacterial Loads by Real Time PCR in Predicting Recurrence of Abnormal Vaginal Flora After Oral Metronidazole Therapy

Abnormal vaginal flora is currently diagnosed among women (20-40%). It is associated with symptoms (bad smell, vaginal discharge) and adverse out-comes in pregnant and not pregnant women. The high recurrence rate raises the long-term effectiveness of therapy. The hypothesis is the persistence of bacteria associated with vaginal flora imbalance as Atopobium vaginae and Gardnerella vaginalis. At the present time there is a lack of an accurate marker for the risk of recurrence.

Women with symptomatic abnormal vaginal flora (a Nugent score of 4-10 or sup or egal 3 Amsel criteria) will be enrolled. Abnormal vaginal flora will be treated with 2g of oral metronidazole. Follow-up will be performed at 1 week,1 month and 12 months after treatment. Vaginal samples will be tested by quantitative real time PCR to determine the vaginal concentrations of A. vaginae, G. vaginalis, and Lactobacillus spp.

Eligibility Criteria:
Inclusion Criteria:

* Woman of more than 18 years, presenting vulvo-vaginal symptoms to type(chap) of smell or abnormal vaginal losses the day of the inclusion and having an imbalance of the vaginal flora objectivized by:
* The presence of at least 3 clinical criteria of Amsel ( 41 ) is a score of Nugent \> 4 ( 42 )
* Woman in genital encircled period of activity (negative pregnancy test in the inclusion) and under effective contraception, including an intra-uterine device (mechanical, hormonal).
* Woman ménopausée with or without hormonal treatment (by way oral, transcutaneous, sous cutaneous, vaginal).
* Woman encircled at the time of the inclusion.
* Having Woman was treated(handled) for a vaginal infection or one imbalance of the vaginal flora more than 7 days ago.
* Woman having understood(included) the progress and the objectives of the study and having agreed to sign a lit(enlightened) consent.
* Only the profitable women of a national insurance scheme will be included

Exclusion Criteria:

* Woman presenting a sexually transmitted infection (infection with gonococcus, with Chlamydia trachomatis, with Trichomonas vaginalis) revealing on the takings realized during the consultation of inclusion but the bacteriological results(profits) of which will be known only secondarily.
* Pregnant Woman presenting to the consultation of inclusion of métrorragies either a break of the pocket of waters or an infectious complication of the pregnancy.
* Woman removing her consent during the study.
* Lost sight Woman.
* Woman deprived of freedom, judicial or administrative;
* Woman hospitalized for quite other reason that looks for her(it);
* Woman hospitalized in a sanitary establishment or social in the other purposes that the research;
* Major Woman except state to express its consent
Trial of Additional Measles Vaccine to Reduce Child Mortality

Background: All observational studies and a few randomised controlled trials (RCT) suggest that early measles vaccine (MV), in particular an early two-dose strategy, has a much better effect on overall mortality than later MV. These results suggest that MV has a non-measles related beneficial effect on child survival.

Objective: To evaluate in a two-site RCT the effect on child survival and other health indicators of a two-dose measles vaccination schedule by providing an additional dose of Edmonston-Zagreb (EZ) MV as soon as possible after 4 months of age as well as the standard measles vaccine at 9 months of age. The trials are planned in Guinea-Bissau and Burkina Faso. The investigators will test a 40-43% reduction of mortality at each site separately and a 32% reduction overall. Based on the results from the RCT, the investigators will assess the cost-effectiveness of the intervention.

Design, Guinea-Bissau: Newborns are followed through the Health and Demographic Surveillance System (HDSS) of the Bandim Health Project. Information on routine and campaign vaccinations will be collected regularly through home visits and health centre registers. Four weeks after having received the third dose of pentavalent vaccine (Penta3), the children will be eligible for enrollment in the trial if they are not severely ill. Eligible children will be invited to take part in the trial. Provided parental informed consent is given, the children will be randomised to MV at 4 and 9 months of age or only at 9 months. Cost estimates will be based on consumption of services and average cost per unit. The incremental cost effectiveness ratio will be calculated.

Sample size, follow-up and analyses: To detect a 40% reduction in overall mortality at each site the investigators intend to enroll at least 3,750 children in Guinea-Bissau. The children will be followed for survival and hospitalisations to 3 years of age or to the end of the study after three years. The investigators will analyse the effects by site and combined; by sex and season; possible interactions with other interventions like campaigns with drugs, vaccines or micronutrients will be explored.

Antibody study: 450 children will be enrolled in a subgroup study to examine the effect of maternal antibody levels on subsequent antibody responses to MV. The children will be followed to 24 months of age and samples collected at 4, 9 and 24 months of age.


Eligibility Criteria:
Inclusion Criteria:

Children who

* received the third dose of pentavalent vaccine at least 28 days before enrolment
* are between 4 and 6 months old
* belong to households of the existing HDSS

Exclusion Criteria:

Children

* with serious malformation
* who are severely sick (needing hospitalisation)
* with high fever (\>38.5 C axillary temperature)
* who are severely malnourished (mid-upper-arm-circumference (MUAC) \< 110 mm and/or bilateral peripheral oedema)
* who have received neonatal vitamin A supplementation
* whose parents/guardians state that they intend to permanently move out of the study area before the child reaches 9 months of age
Paclitaxel, Carboplatin, and Oral Etoposide Followed by Weekly Paclitaxel in High Grade Neuroendocrine Carcinoma

carboplatin and etoposide, followed by maintenance therapy with weekly paclitaxel in patients with poorly differentiated neuroendocrine carcinomas. We hope to identify a "standard treatment" for this unusual group of patients who are not usually eligible for clinical trials.

Upon determination of eligibility, patients will be receive:

* Paclitaxel + Carboplatin + Etoposide

Eligibility Criteria:
Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Metastatic poorly differentiated neuroendocrine carcinoma
* Unknown primary site
* Able to perform activities of daily living with minimal assistance
* Measurable or evaluable disease
* Adequate bone marrow, liver functions and kidney function
* No previous treatment with chemotherapy
* Understand the nature of this study and give written informed consent.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Age \< 18 years
* Previous malignancy within five years
* Women pregnant or lactating
* Recent history of cardiovascular disease
* Meningeal metastases

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
A Psycho-educational Intervention for People With Suicidal in Prisons

This study has been designed as a multicentric, randomized, two parallel-group, controlled trial. The study population will be male and female inmates of nine prisons of Catalonia (Spain). The primary outcome will be the total number of suicidal behaviours for 12 months of follow-up. This project aims to assess the effectiveness of a psycho-educational intervention on reducing the number of suicidal behaviours in the prison environment. If positive, the prison community will have a new tool to curb suicide in prisons.

Background: Suicide rates are higher in the prison environment than in the general population. Prevention involves strategies to promote mental health, early diagnosis, treatment and identification of precipitating factors. The aim of this study is to evaluate the effectiveness of a psychoeducational group intervention performed by rehabilitation professionals to decrease the number of suicidal behaviors in the penitentiary environment.

Methods: This study has been designed as a multicentric, randomized, two parallel-group, controlled trial. The study population will be male and female inmates of nine prisons of Catalonia (Spain). The primary outcome will be the total number of suicidal behaviours for 12 months of follow-up. Secondary outcomes will be suicide risk evaluated with the International Neuropsychiatric Interview (MINI); the severity of suicidal ideations assessed with the Columbia-Suicide Severity Rating Scale (C-SSRS), the presence of depressive and anxiety symptoms \[Hamilton Depression Rating Scale (HDRS) and Hamilton Anxiety Rating Scale (HARS)\] and health-related quality of life (EQ-5D). Other variables will be clinical and socio-demographic. Intervention will consist of 17 psychoeducation sessions for the intervention group and information on suicide for the control group.

Conclusions: This project aims to assess the effectiveness of a psycho-educational intervention on reducing the number of suicidal behaviours in the prison environment. If positive, the prison community will have a new tool to curb suicide in prisons.

Eligibility Criteria:
Inclusion Criteria:

- Participants who have presented some kind of suicidal or high-risk behavior in the criterion of self-directed violence according to the RisCanvi\*.

Exclusion Criteria:

* Decompensation of severe mental disorder
* Intellectual disability
* Cognitive impairment.
* Isolation

  * RisCanvi is an instrument used by penitentiary professionals, based on the individualized and structured assessment of a set of pre-established variables, in order to manage the probabilities of increased and decreased risk of prison inmates for further episodes of violent behavior. The full RisCanvi scale consists of 43 risk factors grouped in the following areas: criminological, personal and biographical, social, family, clinical, and personality. These 43 factors are added to the assessment of the future risk of the emergence of four behaviors: self-directed violence, intra-institutional violence, repeat violence, and prison-breaking).
A Recurrence Nomogram for Hepatoid Adenocarcinoma of the Stomach

This study aims to develop a nomogram to predict postoperative recurrence of HAS and guide individually tailored surveillance strategies.

Patients were included from the China Hepatoid Adenocarcinoma of the Stomach Study Group (China-HASSG) database, which comprises 14 tertiary referral centers. All the patients who had undergone complete resection of a primary HAS between April 2004 and December 2019 were included. First, univariate analysis was performed in Cox regression to identify the risk factors associated with RFS. Next, variables with P\< 0.05 in univariable analysis were included in the multivariable model, and the forward likelihood ratio method was used for analysis to confirm the independent prognostic factors associated with RFS. Finally, based on the results of multivariable analysis, variables that achieved significance at P\< 0.05 were selected to formulate a nomogram.

Eligibility Criteria:
Inclusion Criteria:

* Patients who had undergone complete resection of a primary HAS between April 2004 and December 2019

Exclusion Criteria:

* Patients with metastatic disease, patients who had undergone palliative surgery, patients who had died within 30 days, and patients who were lost to follow-up
Open-label Study of Neuraminidase Inhibitor Treatment in STEMI Patients

Neuraminidase-1 can cause the removal of terminal sialic acid residues from the cell surface or serum sialyloconjugates. The level of Neu5Ac was positively related to the activity of neuraminidase-1. Elevation of Neu5Ac was observed in myocardial ischemia animal model, as well as patients with coronary artery disease. It is interesting to note that Neu5Ac and its regulatory enzyme neuraminidase-1 seem to play a key role in triggering myocardial ischemic injury. Oseltamivir, a structural mimic of sialic acid, was widely used as anti-influenza drug. It suppressed neuraminidase-1 activity in the heart. Targeting neuraminidase-1 may represent a new therapeutic intervention for coronary artery disease. This project seeks to identify whether neuraminidase inhibitor (Oseltamivir) treatment could decrease the myocardial infarct size in STEMI patients and improve clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Between the ages of 18 and 75, regardless of gender;
2. STEMI should be diagnosed by two attending physicians or above, including history, clinical symptoms and signs;
3. Participate voluntarily and sign informed consent, and can be followed up for more than one month.

Exclusion Criteria:

1. Allergic to oseltamivir;
2. Creatinine clearance rate less than 60%;
3. Severe liver insufficiency;
4. Female patients who have or plan to become pregnant;
5. Life expectancy less than one year;
6. Patients refused to comply with the requirements of this study;
7. According to the discretion of investigator, the patient was unable to complete the study or comply with the requirements of the study (for administrative or other reasons).
Iron Overload in African Americans

Iron overload (hemochromatosis) is a condition which causes the intestines to take too much iron into the body from food or pills. The extra iron can build up in the liver, heart, joints, pancreas, sex organs, and other organs. Patients with iron overload can feel well initially, but the iron will eventually damage organs and may lead to an early death. The condition is believed to be passed down from generation to generation. Many studies have been conducted on the condition as it affects Caucasian Americans, few have addressed the condition in African Americans.

Researchers believe it is important to find out as much as possible about the iron overload in African Americans. The goal of this study is to determine the pattern of inheritance of primary iron overload in African American families and to identify the genetic defect causing the condition.

The study will use various tests from simple blood testing (transferritin saturation and serum ferritin levels) to complex genetic tests (segregation analysis and polymerase chain reaction \[PCR\]). The tests will help researchers deterimine iron levels in the blood, presence of antigens that may help trace inheritance, and detect changes in genes that are known to cause iron overload in Caucasians.

The study may not directly benefit the patients participating in it. However, this study may lead to improved methods to diagnose iron overload in the African American population as a whole.

The purpose of this project is to determine the pattern of inheritance of primary iron overload in African American families and to identify the genetic defect. The iron status of index subjects and family members will be determined by measuring transferrin saturation and serum ferritin, and the genetic pattern will be studied with segregation analysis. The chromosomal localization of the iron-loading locus will be pursued by determining HLA haplotypes, by testing for HFE gene mutations, by sequencing portions of genes for molecules involved in iron metabolism, by analyzing polymorphisms in these genes by PCR, by employing molecular methods to screen the genome, and by testing for linkage to iron phenotype with lod scores. Loci for proteins important in iron metabolism will be examined as candidate genes.

Eligibility Criteria:
Index subjects as well as male and female first and second degree family members, greater than 5 years of age, of index subjects with iron overload.

In some cases, more distant family members will also be studied.

No patients less than or equal to 5 years old.
Study of Dual-energy (DE) Contrast-enhanced (CE) Digital Mammography

This is a feasibility study to evaluate dual-energy (DE) contrast-enhanced (CE) digital mammography to detect breast cancer in patients with increased breast density (BI-RADS category c or d). Eligible patients will be invited to have full-field digital mammography and dual-energy (DE) contrast-enhanced (CE) digital mammography to compare accuracy of the imaging methods for the detection of breast cancer.

This is a feasibility study to evaluate dual-energy (DE) contrast-enhanced (CE) digital mammography to detect breast cancer in patients with increased breast density (Breast Imaging-Reporting And Data System category c or d). Eligible patients will be invited to have full-field digital mammography and dual-energy (DE) contrast-enhanced (CE) digital mammography to compare accuracy of the imaging methods for the detection of breast cancer

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. At least 19 years old
3. Glomerular filtration rate\> 60
4. Heterogeneously or extremely dense breasts (BI-RADS category c or d).

Exclusion Criteria:

1. History of iodinated contrast allergy
2. Pregnant or lactating as determined by routine standard practice
3. Personal history of breast cancer
4. History of prior breast excisional biopsy (Patients with a history of core needle biopsy will not be excluded)
5. History of prior breast reduction mammoplasty surgery
6. History of prior breast augmentation surgery
7. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
Communication Skills vs. Mindfulness for IPV

This tests the immediate impact of two brief interventions on couples reporting intimate partner violence using the proximal change experimental design. Couples will be randomly assigned to a mindfulness conditions, a communication exercise or a placebo condition. Outcome measures include observed and experimentally assessed aggression.

This pilot study is designed to test the effects of two brief interventions on communication and emotional expression between intimate partners who have experienced recent domestic violence. In addition, it will provide some basic laboratory findings on differences in distress tolerance between perpetrators and victims of domestic abuse. Specifically, using the proximal change experimental design, couples will engaged in a 7.5 minute conflict discussion while being videotaped and having their autonomic responding monitored. Then they will be randomly assigned to one of three conditions: a communication skills training exercise, a mindfulness condition, or a placebo control. Next, ,couples will engaged in second 7.5 minute conflict discussion. It is hypothesized that those in both the communication skills training and mindfulness condition will display more positive and less aggressive behavior in their second conflict discussion as compared to their first. It is also expected that they will administer less aggression (as measured by delivery of a loud noise) to their partner after both of the active interventions. In addition, multiple measures of distress tolerance will be administered to both partners. It is expected that couples with a characterologically violent perpetrator, he or she will evidence decreased distress tolerance and the victimized partner will evidence increased distress tolerance

Eligibility Criteria:
Inclusion Criteria:

Adult co-habituating couples Reporting some violence in the past year (score \> 0 on CTS2 physical abuse subscale)

Exclusion Criteria:

Homosexual couples Children under 18 non-English speakers
Effect of An Oral Absorbent AST-120 in Late-stage Chronic Kidney Disease (CKD) Patients.

Recent research work has directed especial attention toward a distinct group of uremic retension molecules, called "protein-bound uremic toxins". The prototypes of this group of uremic toxins are indoxyl sulfate and p-cresol. These uremic toxins can promote production of free radical and impair antioxidant system and exerts direct toxicity on different cells and organs, including mesangial, tubular, endothelial cell and osteoblasts. Accumulation of these protein bound uremic toxins results in glomerular sclerosis and interstitial fibrosis of kidneys of uremic rats and confer skeletal resistance to parthyroid hormone in uremic patients. In hemodialysis, high serum p-cresol level is associated with higher cardiovascular mortality.

AST-120 (Kremezin) is a carbonated oral absorbent extensively used in Japan and Korea. It has superior adsorption ability for certain small-molecular weight organic compounds known to accumulate in patients with CKD. In uremic rats and CKD patients, oral administration of AST-120 decreased the elevated pretreatment levels of serum indoxyl sulfate. In Japan, it was reported that AST-120 suppressed the increase in serum creatinine levels, prevented proteinuria, improved uremic symptoms, and, consequently, led to the postponement of dialysis therapy.

Value of AST-120 on the outcome of late-stage CKD patients is still unknown. We hypothesized AST-120 through reduction of level of indoxyl sulfate and p-cresol can improved the morbidity- mortality of CKD patients.

The principal aim of this prospective cohort study is to investigate the effectiveness of AST-120 in incidence of dialysis and mortality of late-stage CKD patients. Determination of this relationship can help to establish new therapeutic strategy in the treatment of late-stage CKD patients.


Eligibility Criteria:
Inclusion Criteria:

* adults aged \> 18 year-old or \< 85 year-old
* eGFR or CCR \< 60 ml/min
* hemoglobin \< 10 g/dL, ESA-naïve, had adequate iron storage (serum ferritin \> 200 ng/dL and transferrin saturation \> 20%)
* no spontaneous renal improvement or progression in past 3 months.

Exclusion Criteria:

* renal transplant recipients, liver cirrhosis, bone marrow disorder
* blood pressure \> 170/80 mmHg in 3 occasions
* recent cardiovascular disease (Coronary artery disease, myocardial ischemia, cerebrovascular disease or peripheral artery disease) or gastrointestinal bleeding in past 3 months
* acute tubular necrosis in the past 3 months
* unwilling to participate in the trial
Effects of Oropharyngeal Exercises on Patients With Primary Snore, Mild and Moderate Obstructive

Randomized study of patients with primary snore, mild and moderate obstructive sleep apnea. Protocol include 40 patients randomized to oropharyngeal exercise or use of nasal dilator, breathing exercise and nasal lavage. The objectives are study the effects of therapy on oropharyngeal in a series of clinical and physiologic and anatomic variables, changes on snore and quality of sleep using Pharyngeal Critical Pressure, Magnetic Resonance, Negative expiratory pressure and snore analyses. Hypothesis that the therapy group (oropharyngeal exercises) will have more modifications compared to the control group.

This is randomized study with multiple primary endpoints. In December 2012 the study also started collecting tongue strength and endurance (IOPI). Because not all patients are able to perform all evaluations, the publications will be divided and presented according to the completion of the required number of patients for each primary endpoint.

Eligibility Criteria:
Inclusion Criteria:

subjects with primary snore, mild and moderate obstructive sleep apnea

Exclusion Criteria:

BMI \> or = 40, craniofacial malformations, smokers, pregnant women, edentulous, total dental prostheses, use of hypnotic medications, stroke, neuromuscular dystrophy, coronary artery disease, chronic heart failure, chronic obstructive pulmonary disease, severe nasal obstructive disease, pharyngeal surgery,already made some kind of treatment for obstructive sleep apnea.