cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Vaccination Coverage of Cirrhotic Patients Followed in the General Hospitals in France in 2021

the purpose of this study is to estimate vacinal coverage against hepatitis A and B viruses, pneumococcus, diphtheria/tetanos and poliomyelitis, influenza virus and covid in cirrhotic patients followed in general hospitals of France and to show the

Cirrhosis is a serious liver disease very common in France, affecting nearly 200,000 people. These patients have an impaired immune response. They are, therefore, more frequently prone to bacterial, viral and fungal infections and these are more severe with high mortality. 30-50% of cirrhotics admitted to a hospital ward have sepsis, with pneumococcal bacterial infections being particularly severe. The risk of developing seasonal influenza is 5.7 times higher in cirrhotics with a risk of mortality multiplied by 169. COVID19 infection is responsible for a very high mortality (34%) in case of severe resuscitation form. Acute infections with hepatitis A (HAV) and B (HBV) viruses frequently lead to worsening liver failure decompensating to cirrhosis, and sometimes life-threatening fulminant hepatitis. Finally, chronic infection with the hepatitis B virus combined with another etiology of cirrhosis accelerates the course of liver disease and promotes the occurrence of hepatocellular carcinoma.

Limiting the incidence of viral and bacterial infections in these patients is crucial. The High Authority of Health (HAS) published recommendations in 2007 advising patients with cirrhosis vaccinations against hepatitis A and B viruses, influenza and against bacterial pneumococcal infections, confirmed by the High Council of Public Health.

There are few data on vaccination coverage among cirrhotic patients. An unpublished French study from 2000 revealed low vaccination rates: 34% for pneumococcus, 55% for influenza, 32 to 42% for the hepatitis B virus and 20 to 38% for the hepatitis A virus. No recent studies have assessed the impact of the HAS recommendations.

The purpose of this study is to estimate vacinal coverage against hepatitis A and B viruses, pneumococcus, diphtheria/tetanos and poliomyelitis, influenza virus and covid in cirrhotic patients followed in general hospitals of France

Eligibility Criteria:
Inclusion Criteria:

* adult patient
* histologically proven or asserted cirrhosis on a combination of clinical, biological, endoscopic and radiological criteria
* follow-up of cirrhosis \> 6 months
* subject informed of the study and not having objected to it.

Exclusion Criteria:

* immunosuppression not related to liver disease: HIV, variable common immune deficiency, chemotherapy, anatomical splenectomy, immunosuppressive treatments for non-hepatic disease
* vaccine contraindication.
Bioequivalence and Food Effect Study in Healthy Volunteers

The purpose of this study is to select the formulation with the optimal pharmacokinetic profile for an hypnotic drug to further develop in the market.

A single-centre, open-label, randomized, single-dose, 6-way crossover study to investigate the pharmacokinetics, safety and tolerability of 6 different formulations of SB-649868 30 mg (Part A) and the effect of food on the selected formulation of SB-649868 pharmacokinetic (Part B) in healthy male volunteers

Eligibility Criteria:
Inclusion criteria:

* Healthy adult male subjects aged between 18 and 65 years of age inclusive.
* Body weight and BMI within the protocol ranges.
* Healthy as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, cardiac monitoring.
* Circulating levels of LH, FSH and testosterone within the normal reference range.
* Signed and dated written informed consent.
* The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.

Exclusion criteria:

* Positive pre-study urine drug screen and alcohol breath test.
* Positive pre-study Hepatitis B surface antigen, Hepatitis C antibody, or HIV ½ result.
* Abuse of alcohol as per protocol criteria.
* Consumption of prohibited food and drink as per protocol.
* Subject who is not prepared to eat the standard meals provided by the site.
* Use of prescription or non-prescription drugs 1 or 2 weeks before the first dose of study medication.
* Where participation in study would result in donation of blood in excess of 500mL within a 56 day period.
* History or presence of allergy to the study drug or drugs of this class, or a history of other allergy.
* Smoking history in the last three months as per protocol.
* An unwillingness of male subjects to follow contraception methods as per protocol.
* History or presence of significant psychiatric, respiratory or gastrointestinal illnesses, hepatic or renal diseases or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
* The subject is unable or unwilling to abstain from strenuous physical activity in the 48 hours before screening and in the 48 hours before and the 48 hours after the treatment period.
* Current or previous (within 6 months) participation in a clinical trial.
Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding

The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Women 18 years or older
* With diagnosis of dysfunctional uterine bleeding without organic pathology
* And with at least one of the following symptoms: prolonged, frequent, or excessive bleeding

Exclusion Criteria:

* The use of steroidal oral contraceptives, or any drug that could alter oral contraception metabolism will be prohibited during the study.
* Women with history of endometrial ablation or dilatation or curettage within 2 months prior to study start will be excluded.
Evaluation of a Collaborative Behavioral Health Program Implementation in Primary Care

This study will give researchers the opportunity to evaluate implementation of the Collaborative Behavioral Health Program (CBHP), based on the collaborative care model for depression, which aims to improve practice for physicians and staff; improve care for patients; and improve clinic operations through a model that allows for more efficient identification and referral for care for depression.

This study used a hybrid Type 2 effectiveness-implementation design of a randomized roll-out trial of the Collaborative Care Model for depression (CoCM) in 11 primary care practices in a large healthcare system affiliated with an academic medical center. The Collaborative Behavioral Health Program (CBHP) is supported by leaders in the healthcare system and the primary care steering committee as a means of improving access to effective mental health services. Implementation strategies including hiring and training the necessary staff for CoCM, audit and feedback procedures, and health information technologies to assist with billing and the patient registry, will be provided for all practices. Using a sequential mixed methods measurement approach, we will assess key stakeholders' perspectives of CBHP roll-out, focused on barriers and facilitators of implementation and sustainability. The Stages of Implementation tool will be used to measure the speed and quantity of implementation activities completed across the stages of implementation preparation, implementation, and sustainment over a 30-month period for each practice. Effectiveness of CBHP for patient-level outcomes will be conducted on depressive symptoms, graduation rates for CBHP, and spillover effects on chronic health conditions.

With its focus on implementation processes and strategies, this study will elucidate the critical drivers of CoCM implementation that are understudied for a program with such a robust evidence base. This study will also be among the first to conduct economic analyses on a fee-for-service model with the new billing codes for CoCM and can inform ways to improve implementation efficiency with our optimization approach to successive practices in the roll-out design. Changes to the protocol and current status of the study are also discussed.

Eligibility Criteria:
Inclusion Criteria:

• PHQ-9 score \> 10

Exclusion Criteria:

* Current suicidality
* Bipolar disorder
* Substance abuse disorder
* Psychosis
* Other severe mental health condition
Can a Brief Primary Care Intervention Affect Healthy Weight Habits

Parents should receive anticipatory guidance about obesity prevention as part of the routine well child visit. Educational resources are needed to help physicians routinely provide these important anticipatory guidance messages. In this study, consecutive parents will be exposed to routine anticipatory guidance messages before the well child visit with the physician. After the clinic visit, parents will be invited to participate in a research study to determine if they plan any changes at home. The key research question of this study is: Can a brief multimedia intervention help parents develop plans to help their children have a healthy weight?


Eligibility Criteria:
Inclusion Criteria:

* English and Spanish speaking parents of 2-12 year old children presenting to the pediatric primary care clinic.

Exclusion Criteria:

* Parent does not speak English or Spanish.
* Child presenting for an acute care visit.
The Physalis Child : Identification of Cognitive and Emotional Factors

The aim of this study is to show presence of cognitive and emotional factors on the beginning and persistence of auditory hallucinations in non-psychotic children. Investigators will describe a significant link between this factors and hallucinations in a sample of non-psychotic children. The results of this sample will be comparing to another group of children of the same age, sex and diagnosis, but without hallucination. Finally, investigators will control the persistence of hallucination on the first group after a six month period.

Background: Hallucinations are a common symptom in pediatric population without psychotic syndrome. Vulnerability, co morbidity and risk factor are already been described. Investigators will study the cognitive and emotional factors on the beginning and persistence of auditory hallucinations in non-psychotic children. The goal of the study is to find a social cognition our emotional impairment to explain auditory hallucinations without psychotic symptoms. Methods: Sample of out non-psychotic patients aged six to eighteen years old with auditory hallucinations were recruited with a self report scale created for this study. Mini International Neuropsychiatric Interview (MINI)-kids interview and "psychosis" section od Kiddie-SADS (Schedule for Affective Disorders and Schizophrenia for school age chidlren) were conducted to determine Diagnostic and Statistical Manual of Mental Disorders (DSM) IV diagnoses. All children patient were spend specifics social cognition (NeuroPsychologic assessment NEPSY II) and emotional (ifferential Emotions Scale (DES) IV, Beliefs About Voices Questionnaire Revised (BAVQ-R)) scales. Each child results will be compared to child result of the same age, sex and diagnosis but without hallucination that passed the same specifics scales. All of child will be control after a six month period to evaluate auditory hallucination persistence and diagnosis evolution. The total period of the study will be twelve month.

Eligibility Criteria:
Inclusion Criteria:

* Twenty participants included with auditory hallucination:

  * Boy or girl
  * French
  * Over six years old and under eighteen years old
  * DSM-IV diagnosis of mood disorder, anxiety, disruptive behavioral disorder, attention deficit hyperactivity disorder, without schizophrenia diagnosis, without mental retardation (Intelligence Quotient (IQ)\>70),
  * Parental and child consent, affiliated to social security.
* Twenty participants included without auditory hallucination:

  * Boy or girl
  * French,
  * Over six years old and under eighteen years old
  * DSM-IV diagnosis of mood disorder, anxiety, disruptive behavioral disorder, attention deficit hyperactivity disorder, without schizophrenia diagnosis, without mental retardation (IQ\>70)
  * Parental and child consent, affiliated to social security.

Exclusion Criteria:

* schizophrenia diagnosis,
* neurologic, genetic or neurosensory disorders
Characteristic Analysis of Retinopathy Associated With High Doses of Interferon α-2b Therapy

The high doses of interferon α-2b therapy in patients with melanomas of the skin may induced retinopathy, especially in the patients with hypertension or diabetes, so these patients should be followed up after treatment.

Patients with melanomas of the skin whose tumors have been resected completely were collected. The detailed ocular examinations including intraocular pressure, slit lamp microscope, indirect ophthalmoscope and color fundus photography were done before the induction therapy, 2 weeks after the induction therapy, after the whole course of induction therapy and each month in the maintenance treatment period. Fundus examinations were carried out by experienced ocular fundus doctors and the retinopathy characteristics were recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women, at least 18 years of age.
2. ECOG performance status 0 or 1.
3. Patients must have histologically confirmed stage IB to stage III primary melanoma of cutaneous origin (AJCC 7th edition classification).
4. Must complete all primary therapy (wide excision with or without lymphadenectomy).

Exclusion Criteria:

1. Mucous membrane or ocular melanoma.
2. Any evidence of distant metastasis (CT-scan of brain, Chest X ray or CT, abdominal ultrasound or CT and ultrasound of regional lymph nodes at screening).
3. Patients with retinopathy on baseline fundoscopic examination at the start of interferon therapy.
4. History of any other malignancy within the last ten years (except basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix).
5. Patients with severe cardiac disease (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina), severe liver disease or severe renal disease.
6. Patients who have a history of depression or other psychiatric diseases requiring hospitalisation.
7. History or presence of autoimmune disease (i.e. autoimmune hepatitis, thyroid auto-immune dysfunction, systemic lupus erythematodes),
8. Unwilling or unable to comply with the requirements of the protocol for the duration of the study.
Probiotics for Irritable Bowel Syndrome

The study aims to investigate the effect of probiotics on IBS-patients symptoms compared to placebo, when given for 6 months.

By draw the investigators give IBS patients, in the age of 18-50 years, capsules with either probiotics or placebo. The patients are to take 2x2 capsules / day for 6 months. The patients are followed for 1 year. They are seen after 3, 6 and 12 months, and are followed by means of monthly letters.

The capsules contain 3 different probiotic strains - Lactobacillus paracasei ssp paracasei F19, Lactobacillus acidophilus La5 and Bifidobacterium Bb12. The dose is 2 x 109 - 10 x 109 CFU/capsule.

The hypothesis is, that there is a clinical difference between the group receiving probiotics and the group receiving placebo.

Background: In management of IBS, no treatments have showed great efficacy. IBS is a non-fatal disease, so safety is a high priority in the choice of treatment. Probiotics is a dietary supplement and have no adverse effects. In some studies it has shown beneficial effect on some of the IBS patients symptoms, but some of the results are questionable. The studies have to be of longer duration, with more patients and the probiotics have to be capsules instead of milk based drinks.

Eligibility Criteria:
Inclusion Criteria:

* Fulfill ROME III criteria
* age 18-50 years
* signed informed content

Exclusion Criteria:

* Danger signals (fever, anaemia, weightloss, blod in stools, predisposition for CRC or IBD)
* abnormal physical examination
* comorbidity
* abuse
* lacking ability to talk and understand danish
* pregnancy
* For patients \> 40 years. Changed bowel habits, with duration \> 3 weeks, but \< 1 year
Increase in MedDiet Adherence in Pregnancy

In the present randomised-controlled 3-month dietary intervention, we aim to a) increase Mediterranean diet adherence among apparently healthy pregnant women with the support of CDSS, and b) assess nutritional status and psychological parameters (anxiety and depression). To our knowledge, this is the first attempt investigating the effectiveness of CDSS in Mediterranean diet adherence of pregnant women.

In this two-armed, single center, randomised controlled 3-month trial, apparently healthy pregnant women are randomly assigned to either the Control or the Intervention arm. The appointed statistician applies simple randomisation through a computer-generated randomization sequence. Treatment allocation is exposed to the statistician only after the assessment of outcomes.

At baseline before the start of the trial, each enrolled participant is appointed to a well-experienced dietician. In the Intervention group (CDSS group), women receive a personalised daily dietary plan based on the Mediterranean diet and according to participant's needs, habits and preferences. All elements needed for the synthesis of the dietary plan i.e., gestational age, body mass index (BMI) before the fetus conception, daily total energy expenditure, physical activity level based on the concept of metabolic equivalent of task (MET), caloric needs according to nutritional status, and macronutrient distribution are calculated using the CDSS database. The CDSS-dietary regimen consists of a daily eating program that was renewed every 15 days, paired with nutritional recommendations that are in line with the "National Dietary Guidelines for Pregnancy" \[http://www.diatrofikoiodigoi.gr/?page=summary-women\].

Before the start of the trial, women are trained to use the CDSS and receive individual login passwords. On a weekly basis, participants are instructed to input a 3-day food diary in the CDSS, made automatically available to the dieticians. When entering the CDSS, women monitor their personal goals i.e., body weight, physical activity, consumption of fruits and vegetables. Every other week, phone interviews are also performed to support nutritional and lifestyle consultation. Additionally, unexpected phone calls are made to obtain 24-hour dietary recalls.

Participants of the Control group do not have access to CDSS and only received general lifestyle guidelines based on the "National Dietary Guidelines for Pregnancy" via scheduled phone calls every 15 days with the appointed dietician. Women of the Control group are instructed to keep a 3-day food diary every week, sent by e-mail to the appointed dietician. Again, unexpected phone calls are made to obtain 24-hour dietary recalls.

Eligibility Criteria:
Inclusion Criteria:

* healthy pregnant women over 18 years

Exclusion Criteria:

* any metabolic disorder
A Randomised Trial Comparing Anterior Versus Posterior Approach in Total Hip Replacement

This is a single-centre, randomised, prospective clinical follow-up study to evaluate clinical outcome and gait analysis after total hip arthroplasty using the standard postero-lateral approach or the minimally invasive anterior approach.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18-75 years at time of surgery.
* Those presenting with primary or secondary osteoarthritis and/or rheumatoid arthritis of the hip.
* Those deemed capable of giving informed consent, understanding the aims of the study and expressing willingness to comply with the post-operative review programme.
* Patients who signed the study consent form prior to surgery.

Exclusion Criteria:

* Pregnant women or women who plan to conceive in the future.
* Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems.
* Those already treated by with a Total Hip Replacement (THR) (i.e. requiring a revision hip replacement).
* Those with co-existent ipsilateral knee disease or back problems
* Muscle contracture around the hip joint
* Individuals who have undergone organ transplant.
* Those with a known co-existent medical condition where death is anticipated within five years due to the pre-existing medical condition.
* Individuals who have had a THR on the contra-lateral side within the 6 months.
* Individuals who have undergone a THR on the contralateral side and whose outcome is considered unsatisfactory or not good. An unsatisfactory or poor result is defined as achieving a total UCLA score (including activity) \< 16 points.
* Individuals requiring bilateral hip replacement.
* Individuals whose body mass index (BMI; kg/m2) \>35.
* Individuals with active or suspected infection or sepsis.
* Individuals with renal failure and/or renal insufficiency.
* Patients with severe forms of developmental dysplasia of the hip (DDH): Crowe types II, III, IV.
Effectiveness and Implementation of a Clinician Decision Support System to Prevent Suicidal Behaviors

The primary aim of this project are to evaluate a comprehensive, practice-ready, and deployment-focused strategy for improving the prediction and prevention of suicide attempts among a sample of 4,000 patients presenting to an ED with a psychiatric concern. Our first aim is to evaluate the effects of providing information about risk of patient suicidal behavior to ED clinicians. We hypothesize that patients randomly assigned to have their clinician receive their risk score will have a lower rate of suicide attempts during 6-month follow-up and that this effect will be mediated by changes in clinician decision-making.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Presentation to emergency psychiatry service

Exclusion Criteria:

* Inability to understand study procedures and provide informed consent, such as those with gross cognitive impairment (including florid psychosis), intellectual disability, dementia, acute intoxication
* Presence of violent or extremely agitated behavior