cyrilzakka/clinical-trials huggingface dataset:
Extended Specialized Assertive Intervention for First Episode Psychosis

In a randomized clinical trial, the researchers want to investigate if the positive short-term outcomes (first 1-2 years), achieved with specialized assertive intervention programme (OPUS), can be maintained for five years if the specialized treatment is sustained over the first five years in comparison to only two years of specialized treatment followed by three years of standard treatment.

The Danish OPUS I trial succeeded in randomizing 547 patients with first-episode psychosis to a two-year specialized intensive treatment program (OPUS) or standard treatment. The results clearly favored OPUS treatment, and psychotic and negative symptoms, substance abuse, adherence to treatment, use of anti-psychotic medication, user satisfaction, and use of bed days were better in OPUS compared to standard treatment. However, the five-year follow-up, three years after patients from OPUS were transferred to standard treatment, showed that the positive clinical effects were not sustained, when the intensive treatment was terminated, except from OPUS-patients being less likely to stay in institutions than patients who received standard care.

Objective: The aim in OPUS II trial is to compare the effect of five-years versus two-years specialized assertive intervention program (OPUS-treatment) for first episode psychosis on clinical symptoms, substance abuse, institutionalization, and labor market affiliation.

Hypothesis: It is possible to maintain the positive results of the intensive two-year intervention in another three years for those who keep receiving the specialized assertive intervention program.

Design: Open label randomized clinical trial. Setting: Psychiatric Center Bispebjerg and Center for Psychiatric Research Aarhus, Denmark.Participants: 400 patients with first episode of schizophrenia spectrum disorder received treatment in one of the six OPUS - teams for 1½ years.

Intervention: Another 3½ years OPUS-treatment versus ½ year OPUS-treatment and thereafter referral to standard treatment. The extended OPUS treatment consist modified assertive case management, rational pharmacotherapy, family psycho-educational intervention, group interventions to aid with recovery, social skills training, cognitive behavior therapy when indicated, and crisis intervention. OPUS-treatment is tailored to meet the individual patient's needs.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 18 - 37 years
* first episode psychosis in schizophrenia spectrum
* treated for 1½ year in the five OPUS teams in the Capital Region and the OPUS teams in Region Midt
* patients who will give signed informed consent to participate in the trial

Exclusion Criteria:

* patients who are not treated in one of the OPUS team in the Capital Region and Region Midt
* patients who don't give signed informed consent to participate in the study
Prediction of the Severity of Female SUI by Measuring New Static and Dynamic Ultrasound Parameters of the Urethra

This study aims to evaluate the correlation of the ultrasonic functional length of the urethra and the incontinence urinary disorder (IUD). The goal is to predict the severity of the IU by measuring new static and dynamic ultrasound parameters of the urethra.

The urinary incontinence is a disorder which affects 25 to 45% of women. Nowadays, the role of urethral tissue in IUD is not explored although well viewed in perineal ultrasound. Our actual knowledge demonstrates that urodynamic ultrasound is reliable to establish the bladder neck mobility. And the posterior urethral wall mobility was often associated to the stress urinary incontinence. Two elements appeared to indicate the elasticity of the urethral environment: functional length urethral variation and urethral closure angle variation during Valsalva manoeuvres compared to rest. This study aims to evaluate the correlation of the ultrasonic functional length of the urethra and the incontinence urinary disorder for the purpose to predict the severity of this syndrome.

Eligibility Criteria:
Inclusion Criteria:

* All patients aged over 18 years addressed to pelvic ultrasound

Exclusion Criteria:

* Pregnant
* Post-partum (under 6 month of childbirth)
* Operated for a genitourinary prolapse or/and urinary incontinence
* Utero vaginal symptomatic prolapse
* Overactive bladder ± UI by
* Dysuria
* Severe deep pelvic endometriosis
* Respiratory failure (Unable to perform the Valsalva manoeuvres)
* History of pelvic cancer
* Unable to understand the information communicated
Development and Evaluation of Hygie, a New Serious Game for Continuing Medical Education of General Practitioners

We produced a prototype video game called Hygie on the 5 most common reasons of consultation in general practice using 9 articles from independent journals based on evidence (reviews by Prescrire and Minerva). We then carried out a randomized trial comparing the learning provided by a week of access to the game versus source articles, in a population of clinical supervisors (CS) from 13 French departments of general practice.

Continuing medical education is important but burdensome work for general practitioners. Current training tools have limitations and may lack the ability to engage some practitioners. Serious games are new pedagogical tools that use video games as engaging education tools. They have significant advantages in terms of efficiency and dissemination.

The aim of this work was to create a new serious game and to evaluate it in terms of efficiency and satisfaction, comparing it with a traditional method of continuing education: article reading.

We produced a prototype video game called Hygie on the 5 most common reasons of consultation in general practice using 9 articles from independent journals based on evidence (reviews by Prescrire and Minerva). We then carried out a randomized trial comparing the learning provided by a week of access to the game versus source articles, in a population of clinical supervisors (CS) from 14 French departments of general practice.

Eligibility Criteria:
Inclusion Criteria:

* to be a french general practice clinical supervisor

Exclusion Criteria:

* none
Comparing the Effectiveness of Two Dietary Interventions for Fecal Incontinence

Background:

Fecal incontinence (FI) is a common complaint, and is often associated with diarrhea and urgency. Foods that are high in fermentable oligo-, di-, and mono-saccharides and polyols (FODMAPs) cause symptoms of diarrhea and urgency. Thus, assessing the impact of a low FODMAP diet in FI patients is needed.

Aims:

1. Compare the treatment response with a low FODMAP vs. psyllium based on number of episodes in patients with FI.
2. Compare the efficacy of a low FODMAP diet vs. psyllium in patients with FI on pre-specified clinical and quality of life endpoints.

Methods:

This is a prospective, randomized control trial of adults meeting the Rome III criteria for FI and at least 1 episode of FI due to loose stool per week. After a 2 week screening period and randomization, during which the severity of symptoms will be assessed and eligibility determined, patients will be randomized to psyllium vs. low FODMAP diet for 4 weeks. A total of 20 patients will be recruited for each arm.

The primary endpoint will be treatment response based on number of incontinence episodes. A treatment response is defined as a reduction in the number of FI episodes/week.


Eligibility Criteria:
Inclusion Criteria

1. Experience at least 1 episode/week of unintentional loss of stool associated with diarrhea/loose stool (Bristol stool scale of 5 or greater).
2. Subjects aged 18 and older meeting the Rome III criteria for Functional Fecal incontinence diagnostic criteria:

Recurrent uncontrolled passage of fecal material in an individual and one or more of the following:

1. Abnormal functioning of normally innervated and structurally intact muscles
2. Minor abnormalities of sphincter structure and/or innervation
3. Normal or disordered bowel habits, (i.e., diarrhea) Criteria fulfilled for the last 3 months

Exclusion Criteria

1. Abnormal innervation caused by lesion(s) within the brain (e.g., dementia), spinal cord, or sacral nerve roots, or mixed lesions (e.g., multiple sclerosis), or as part of a generalized peripheral or autonomic neuropathy
2. Anal sphincter abnormalities associated with a multisystem disease (e.g., scleroderma)
3. Structural or neurogenic abnormalities believed to be the major or primary cause of fecal incontinence
4. Have cognitive dysfunction or unable to understand or provide written informed consent
5. Pregnancy
6. FI with solid stool only
7. Comorbid medical problems that may affect gastrointestinal transit or motility: Inflammatory bowel disease, Extraintestinal disease known to affect the gastrointestinal system (i.e., scleroderma, unstable thyroid disease, etc.),Severe renal or hepatic disease
8. Previous abdominal surgery other than appendectomy, cholecystectomy, and gynecologic/urologic surgery.
9. . Previous treatment with low FODMAP diet.
10. Concurrent medications not permitted including probiotics, antibiotics, and narcotics.
11. Active participation in another form of dietary therapy.
Study of Plozasiran (ARO-APOC3) in Adults With Severe Hypertriglyceridemia

This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with severe hypertriglyceridemia (SHTG). After providing informed consent eligible participants will be randomized to receive 4 doses (once every 3 months) of plozasiran or placebo, and be evaluated for efficacy and safety. After month 12, eligible participants will be offered an opportunity to continue in an optional open-label extension under a separate protocol.


Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of severe hypertriglyceridemia (SHTG) and prior documented evidence (medical history) of fasting TG levels of ≥ 500 mg/dL (≥5.65mmol/L)
* Mean fasting TG level ≥500 mg/dL (≥5.65 mmol/L) collected at 2 separate and consecutive visits at least 7 days apart and no more than 17 days apart during the screening period
* Fasting low density lipoprotein-cholesterol (LDL-C) ≤130 mg/dL (≤3.37 mmol/L) at screening
* Screening HbA1C ≤8.5%
* Willing to follow diet counseling and maintain a stable low-fat diet
* Must be on standard of care lipid-lowering medications per local guidelines (unless documented as intolerant as determined by the Investigator)

Exclusion Criteria:

* Use of any hepatocyte-targeted small interfering ribonucleic acid (siRNA) that targets lipids and/or triglycerides within 365 days before Day 1 (except inclisiran, which is permitted). Administration of investigational drug and inclisiran must be separated by at least 4 weeks
* Use of any other hepatocyte-targeted siRNA or antisense oligonucleotide molecule within 60 days or within 5-half-lives before Day 1 based on plasma pharmacokinetics (PK), whichever is longer
* Known diagnosis of familial chylomicronemia syndrome (FCS) (type 1 Hyperlipoproteinemia) by documentation of confirmed homozygote or double heterozygote for loss-of-function mutations in type 1-causing genes
* Acute pancreatitis within 4 weeks prior to screening
* Body mass index \>45kg/m\^2

Note: Additional Inclusion/Exclusion criteria may apply per protocol
Occurrence of Traumatic Dental Injury in a Group of Egyptian Autistic Children Compared to Normal Children: (A Cohort Study)

The aim of the study is to assess the occurrence of traumatic dental Injury in a group of Egyptian Autistic Children compared to normal children.

Population: Egyptian children Exposure: Autistic children. Control: Normal children. Outcome: Primary Outcome: occurence of Traumatic injury. Secondary Outcome: Risk factor, Oral habits.

This study is a cohort study, the study group compromise a group of children with ASD, the control group compromise a group of normal children.

Study group will be recruited from Abbaseya Mental Health Hospital and Advance Center For Handicapped and Autistic Children.

Control group will be recruited from Diagnosis Clinic of Pediatric Dentistry and Dental Public Health Department at Faculty of Dentistry Cairo University.

The investigator will make an interview with the Parents of both groups to fill the A questionnaire (taken from different articles, modified by the investigator to accommodate the aims of the study.) then they will be assigned Informed consent, children whose parents agreed to participate in the study were recruited.

Inclusion criteria:

* Autistic and normal children.
* children aged from 6 to 12 years old irrespective of sex.

Exclusion criteria:

* Behavior of the child is inadequate.
* Children with dental structural defect.
* parents that refused to give informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Autistic and normal children.
* children aged from 6 to 12 years old irrespective of sex.

Exclusion Criteria:

* Behavior of the child is inadequate.
* Children with dental structural defect.
* parents that refused to give informed consent.
Open Study to Evaluate the Safety of Levocetirizine in Young Children (2 - 6 Years) Suffering From Allergic Rhinitis

4 week open study to evaluate the safety of levocetirizine in young children (2 - 6 years) suffering from allergic rhinitis. As secondary objective, this study will assess the efficacy of the treatment by means of the T4SS (Total 4 symptoms scores of allergic rhinitis) and each of the 4 individual rhinitis symptom scores


Eligibility Criteria:
Inclusion Criteria:

* At Visit 1:

  * Male or female outpatients aged 2 to 6 years old.
  * Subjects suffering from allergic rhinitis (perennial and/or seasonal) and symptomatic as attested by the Daily Record Card (DRC).
* At Visit 2:

  * Respected wash-out periods for the forbidden medication.

Exclusion Criteria:

* • Presence of asthma requiring treatment by inhaled corticosteroids.

  * Atopic dermatitis or urticaria requiring antihistamine treatment or the administration of oral or topical corticosteroids, or any other disease requiring the administration of oral or topical corticosteroids, immunomodulatory drugs, anti-inflammatory, or cytotoxic drugs.
  * Use during the course of the study, or during the specific wash-out periods, of any of the following medications: intranasal or systemic corticosteroids (within 7 days), ketotifen (within 7 days), nedocromil or cromoglicate (within 7 days), loratadine and desloratadine (within 7 days), other antihistamines (within 3 days) or decongestants (per os, nasal spray, or drops - within 3 days), or any other concomitant medications that, in the opinion of the Investigator, interfered with the study.
  * Initiation or change of dose of an immunotherapy regimen during the course of the study.
Clinical Implication of Retinitis Pigmentosa Molecular Diagnostic Using High Throughput Sequencing.

The retinitis pigmentosa (RP) are genetic conditions that cause retinal degeneration leading to severe low vision and is the leading cause of consultation in reference centers dedicated to the ophthalmic genetics. These rare diseases are characterized by a triple heterogeneity (clinical, genetic and molecular), which made them unreachable by traditional molecular diagnostic sequencing technology by the large number of genes to be tested (\> 190).

The advent of high-throughput sequencing (NGS) and targeted capture has opened unexpected possibilities of investigation and ultimately to improve the care of patients. This project aims to study the genetic and molecular epidemiology of an interregional french (grand EST) cohort of patients. Patients receive a detailed retinal phenotype (visual acuity, visual field, photographs of the fundus and ERG). Their DNA will be analyzed by NGS targets the 190 known genes (https://sph.uth.edu/retnet/).

This research will provide a molecular epidemiological cohort study compared to prior publications on the frequency of genes involved. The benefit for patients is important to: establish a mode of transmission of the disease and optimize genetic counseling (currently very empirical); establish phenotype-genotype correlations in the French population (very few studies to date) and from the data of international literature; identify patients likely to be included in future therapeutic protocols of research; identify patients with significant potential for future projects to identify new genes.

The primary purpose of the protocol is to use high throughput sequencing to identify pathogenic variants in genes involved in RP.

The secondary purposes will be the following:

* Determining the diagnostic yield
* Study the genotype-phenotype correlation.

The secondary purposes will be the following:

* Determining the diagnostic yield
* Study the genotype-phenotype correlation


Eligibility Criteria:
Inclusion Criteria:

* Subject of both sex, aged at least 2 years, being diagnosed with an RP, and/or having a family history of RP
* Informed about the results of the preliminary medical visit, or which (s) holder (s) parental authority or the guardian / curator has (have) was (been) informed
* Informed consent signed
* Affiliation to the French health system

Exclusion Criteria:

* The patient does not want to participate to the protocol
* Intercurrent diseases do not allow the practice of tests provided for this protocol
* Phenocopy
* Subject excluded or being excluded by another protocol
* Subject in emergency case
* Subject under judicial protection
Drug Concentrations in Breast Milk and Prediction of Blood Levels of the Breastfed Infants

There is a significant lack of information on drug secretion into milk and infant exposure. As a first step to address this issue, the investigators examine milk concentrations of selected drugs prescribed to breastfeeding women, which lack milk excretion data. Milk data will be analyzed using population pharmacokinetic approaches, when possible, and acquired data of drug concentration profiles in milk will be combined with infant physiologically-based pharmacokinetic (PBPK) models to predict infant exposure levels.

In this study the investigators measure drug concentrations in breast milk (and optional blood) samples collected through sparse and flexible sampling strategy mitigating intense approaches of conventional PK study. Whenever possible, population PK method is used to characterize milk concentration profiles of the selected drugs. The obtained data is further processed through a PBPK model of infant to predict infant drug exposure levels.

The study also includes an optional pharmacogenetic part. This will allow the investigators to understand how variations in genetic composition plays role in breaking down drugs and how it affects the drug transfer into breast milk.

This study is conducted at three sites: Hospital for Sick Children (leading site), CHU Sainte Justine Hospital, Montreal (Study Lab: for drug measurement), and University of Waterloo (Modelling Core: to create computer model).

Eligibility Criteria:
Inclusion Criteria for breastfeeding women

* Age of 18 years or older
* Lactating women taking at least one of the study target drugs per Standard of Care
* Obtained informed consent
* Ability to communicate in English

Exclusion Criteria for breastfeeding women

* Any concomitant medication
* Known pregnancy during PK sampling

Inclusion criteria for their infant

* Older than 1 week
* Healthy

Exclusion criteria for their infant

* Concomitant medical treatment
Impact of Nerve-sparing Radical Hysterectomy on Patients' Urinary Dynamics

Background: Radical hysterectomy is an important therapy for early cervical cancer. Disfunction of urinary dynamics is the most common postoperative adverse effects, which had negative impact on patients' quality of life. Nerve sparing radical hysterectomy (NSRH) could reserve inferior hypogastric plexus (IHP) innervating bladder, hence improving postoperative urinary dynamics. Furthermore impact of different energy instruments on urinary dynamic isn't clear.

Objectives: This study is to compare urinary dynamics before and after NSRH, and to analyze the difference between BiClamp forcep (BiClamp® forcep, ERBE Elektromedizin, GmbH, Tuebingen, Germany) and water jet (ERBEJET®2) about the effects of dissecting IHP.

Study population: Cervical cancer of FIGO IB stage, among which 120 cases are enrolled to randomly allocated to BiClamp group or water jet group.

Intervention: Patients accept NSRH which all will be accomplished by Professor Ming Wu.

Methods: All surgical patients are accessed via urinary dynamics before and four months after NSRH. On the 14th day after surgeries, urinary catheter will be removed and residual urine volume (RUV) will be measured. For patients of RUV \> 100 ml, urinary catheter will be replaced.

Primary study endpoint: the successful rate of removing urinary catheter on the 14th day after NSRH.

Secondary study endpoint: urinary dynamics four months after NSRH.


Eligibility Criteria:
Inclusion Criteria:

* FIGO stage IB
* ASA score 0-2

Exclusion Criteria:

* Radiotherapy or chemotherapy before surgeries
* ASA score \> 2
* With abnormal urinary dynamics before surgeries
Immune Monitoring in Sensitized Patients at Risk of Rejection

The purpose of this study is to test the effect of anti-rejection medications on your immune system

Recipients of deceased or living donor transplants with calculated percent reactive antibody (cPRA) of 50% or greater at University of California, San Francisco (UCSF) will be enrolled in the trial. Samples for Kidney Solid Organ Response Test (kSORT) will be obtained pre-transplant (and immunosuppression) and post-transplant (see Table 1). Urine will be obtained at the same true intervals including pre-transplant in patients who still produce urine to correlate with graft rejection, inflammation and kSORT. A piece (minimum 1/3 core) of the protocol or for cause biopsy tissue will be saved in Ribonucleic acids (RNA) later for gene expression analysis as a correlate of graft inflammation with the biopsy, kSORT and urine. In addition, samples will be when patients are undergoing cause kidney biopsy, prior to treatment intensification and procedure. Patient's who are treated for rejection, will have additional samples obtained 2-4 weeks after treatment of rejection and at the time of any followup biopsy for monitoring resolution of biopsy confirmed acute rejection.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older able to consent
2. No history of HIV, hepatitis C and active hepatitis B infection
3. cPRA ≥ 50%

Exclusion Criteria:

1. Patients on Coumadin
2. Human Leukocyte antigen (HLA) identical donor recipient patients