cyrilzakka/clinical-trials huggingface dataset:
Structured Treatment Interruptions in Chronic HIV Infection

In the last years Structured Treatment Interruptions (STI) have been proposed to reduce HAART-related toxicity and to increase patients' compliance. ISS PART is a randomized comparison of repeated STIs versus continuous HAART in chronically HIV-infected subjects with persistent suppression of viral replication. The two arms of the study will be compared in terms of immunological response (proportion of patients with CD4\>500/mmc) at 2 years.

Patients are randomized in a 1 to 1 ratio to continue their current antiretroviral regimen (Arm A) or to undergo structured treatment interruptions (STI) (Arm B) according to the following scheme: STIs of 1, 1, 2, 2 and 3 months each followed by a 3-month therapy period.

During STIs, therapy is resumed in the presence of an HIV-RNA rebound \> 50,000 copies/ml or of a CD4+ T cell decline \> 25% of the baseline count (\> 35% for patients with CD4+ \> 500/mm3 at randomization). After the first cycle, subsequent STIs are performed only if an HIV-RNA level \< 400 copies/ml is reached after 2 months of therapy resumption.

At the time of treatment interruptions patients in arm B who are on treatment with non-nucleoside reverse transcriptase inhibitors suspend these drugs first and continue the treatment with the other drugs of the combination for 3 days if nevirapine-treated and for 6 days in case of previous efavirenz-based regimen.

Patients are seen at the clinical site every three months for arm A and monthly for arm B. On these occasions, blood samples are obtained for biochemical and viro-immunological assessments.

The toxicity grading scale of the AIDS Clinical Trial Group (ACTG) is used for the reporting of clinical and laboratory adverse events.

In arm B, plasma genotype is obtained in samples taken after 15 or 30 days of drug suspension.

Patients will discontinue the study in case of : early therapy resumption for 2 consecutive times (only arm B patients); acute retroviral syndrome (only for arm B patients); AIDS-defining event; severe adverse event; pregnancy; non-compliance; patient' s request; physician's decision.

Eligibility Criteria:
Inclusion Criteria:

* first-line antiretroviral therapy (3 or 4 drugs) for 6 to 18 months (one previous therapy change for toxicity or non-compliance is allowed)
* HIV-RNA level below 400 copies/ml for at least 6 months;
* CD4+ count \> 350 /mm3;
* pre-HAART CD4+ \> 100/mm3
* no previous AIDS diagnosis.

Exclusion Criteria:

* Previous antiretroviral therapy with 1 or 2 drugs (except ARV prophylaxis in pregnancy)
* Pregnancy or breastfeeding
* Previous diagnosis of AIDS
* Grade 3 or 4 adverse event in the 15 days before enrolment
* Neoplasia
* Previous therapy with IL-2, interferon (in the last 2 years) or experimental therapies
ADHD: Gaps Between Patients With Alcohol-dependence and Impact on Relapse

Some recent studies have found that adult attention deficit - hyperactivity disorder (ADHD) was frequent among patients with alcohol-dependence. However, no investigation has ever addressed whether ADHD may impact the drinking outcome.

Moreover, most of the different aforementioned studies assessed ADHD using the ADHD self-report scale (ASRS). The ASRS is a screening questionnaire that is of limited diagnostic value, and the overrepresentation of high-score ASRS among patients with alcohol-dependence could be in part due to differential diagnoses such as antisocial or borderline personality disorders, executive function impairments, or isolated impulsiveness.

The study aims to evaluate "ADHD: Gaps between patients with Alcohol Dependence and Impact on early Relapse" (AGADIR). In AGADIR, subjects with alcohol-dependence are recruited at the end of a residential detoxification program. They are assessed for ADHD using the ASRS, but also with a standardized diagnostic tool, i.e., the Diagnostic Interview for ADHD in adults (DIVA 2.0). Potential differential diagnoses are screened during the baseline visit. The patients are followed-up during the 12 first post-detox weeks, through a standardized psychosocial treatment. ASRS is re-performed at the end of the follow-up.


Eligibility Criteria:
Inclusion Criteria:

* current DSM-IV-Tr criteria for alcohol-dependence
* current residential alcohol detoxification program

Non-inclusion Criteria:

* concurrent alcohol withdrawal symptoms, i.e., CIWA-Ar ≥ 10
* benzodiazepine diazepam-equivalent dose \> 30 mg
* medical history of neurological impairment (excluding alcohol-induced cognitive disorders)
* guardianship or loss of liberty
* pregnant or lactating woman
Design and Development of an Infant's Oriented Face Mask

Face masks are used for many respiratory care applications such as anaesthesia, resuscitation, and aerosol therapy. None of the currently available face mask for infants and young children are specifically designed and developed for infants. The aim of this study is to design, develop and test the first infant's oriented face mask.

To achieve this ultimate goal we will first define appropriate sizes of infants' faces that would be used as templates for the design and development of optimally fitted model masks. In the next stage we will use these masks and incorporate the infants' own soother (pacifier) into a new SootherMask (SM). In the last part of the study we will compare acceptance levels between Soothermask (SM) and a conventional commodity masks without a pacifier.

Not all face masks are "born equal" and care must be taken in mask design, particularly for the early pediatric age group. Unfortunately, facemasks provided for infants and young children have been merely smaller versions of those used for adults with little consideration given to their special needs

We believe that a major advance in answering the needs of infants rely in making the mask more friendly user by making sucking on the infant's soother an integral part of the newly developed mask. This is based on the following premises:

1. Sucking is a vital feeding and soothing activity of infants. Incorporating sucking into the act of aerosol delivery greatly reduces the fear engendered and inconvenience of putting an obtrusive mask on the infant's face.
2. Linking the mask to the sucking action ensures a tight seal between the mask and the face. Every time the baby sucks on the pacifier or the bottle nipple, the mask is pressed onto the face by atmospheric pressure thus ensuring a good mask to face seal. This then also ensures that the aerosol that has been sprayed into the holding chamber will be drawn into the baby's lungs through the nose with each inspiration.
3. The material of the mask's rim is relatively wide, soft, corrugated and is thus highly flexible. This makes the mask easily compressible without overdue force on the infant's face. Thus, the act of sucking attracts the mask to the child's face, assists in achieving a good seal and compresses it thus substantially reducing the dead space volume of the mask.

The ultimate goal of the present study is to answer these specific needs of infants and to develop an appropriate infant's oriented face mask. In order to achieve this goal the study will have three specific objectives.

Objective #1 Define morphometric data of infants' faces Objective #2 Design and develop an optimally adapted face mask SootherMask (SM) based on the morphometric results Objective #3 Compare the acceptance levels between Soothermask (SM) and a conventional commonly used masks without a pacifier.

Eligibility Criteria:
Inclusion Criteria:

Signed informed consent

Exclusion Criteria:

Non cooperation with procedure
Weight Loss and Maintenance for Individuals With Intellectual Developmental Disabilities (IDD)

Individuals with intellectual developmental disabilities (IDD) have obesity rates that exceed those in the general population, consume energy dense diets, and perform very little physical activity (PA). Overweight and obesity are independent risk factors for chronic disease such as cancer, diabetes, hypertension, and cardiovascular disease in both the general population and those with IDD.

The investigators modified the Stop Light Diet (SLDm) to include reduced energy pre-packaged meals (PM) for 6 months, encouraged consumption of low energy shakes and 35 fruits and vegetables (F/V) per week. The investigators will compare participants who use the SLDm with participants who use a reduced energy and fat diet with meal plans, based off of the current American Dietetic Association recommended car for weight reduction plan.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mile to moderate IDD as determined by a Community Service Provider operating in Kansas under the auspices of a Community Developmental Disability Organization (CDDO)
* Able to understand and give informed consent
* If there is a guardian with power of attorney, both the guardian and participant must give informed consent
* Participants must live in a supported living condition either at home or with no more than 1-4 residents and have a care giver (ie. parent, staff) who assists with food shopping, meal planning, and meal preparation
* Overweight or obese determined by a BMI \> 25 kg/m2
* Able to walk
* Clearance provided from physician
* Able to communicate preferences

Exclusion Criteria:

* Uncontrolled hypertension
* Severe heart disease
* Cancer diagnosis
* Positive for HIV
Randomized Trial of a Quality Improvement Intervention to Decrease D2B Time in Primary PCI for AMI

The primary objective of this study is to assess whether an aggressive quality improvement intervention strategy will decrease time from hospital presentation to first balloon inflation in non-transfer patients with acute ST segment elevation MI (STEMI) treated with primary percutaneous coronary intervention (PCI). Twelve hospitals in Michigan were randomized to either aggressive intervention or control. The intervention consisted of Grand Rounds at each hospital, sharing of best practices, and coordinating center staff working closely with staff at each intervention hospital to discuss solutions to barriers to rapid treatment for STEMI patients.

The participating hospitals randomized to the aggressive intervention strategy actively worked to create teams to analyze processes of care for STEMI patients, identify areas needing improvement, and implemented strategies to streamline treatment.

Hospitals randomized to control were instructed to conduct "business as usual".

Eligibility Criteria:
Inclusion Criteria:

* Acute ST segment myocardial infarction, non transfer patients, with symptom onset to balloon time less than or equal to 24 hours.

Exclusion Criteria:

* Patients transferred from one facility to another,
* non ST segment myocardial infarction patients.
Characterisation of Occupational Allergy to Drosophila

Allergy is a very common problem and can be a handicap in everyday life, specially when symptoms occur at work place. Some persons working with drosophila developed respiratory symptoms. Investigators tried to analyze if these manifestations could be due to a specific allergy to drosophila.

To do so, investigators invited laboratory workers who presented any symptoms in presence of drosophila to undergo skin prick tests in order to determine if a specific sensibilization to drosophila exists. Then, a blood sample is taken from these persons to research specific IgE directed against drosophila. By this way, investigators hope determine if a specific allergy to drosophila exists, its characteristics as prevalence, symptoms, populations concerned...in order to better protect laboratory workers and prevent allergy incidence.

Eligibility Criteria:
Inclusion Criteria:

* major males or females (aged \<68) who work in laboratory with drosophila in Montpellier (France)
* clinical symptoms in presence of drosophila
* The subject must be affiliated to a social security scheme
* Provision of informed consent prior to any study specific procedures

Exclusion Criteria:

* The patient has indicated against (or incompatible drug combination) concerning the implementation of a prick test
* antihistamine cure in progress
* Inability to understand the nature and goals of the study and / or communication difficulties with the investigator
* No affiliation to a French social security recipient or not such a scheme
* Major protected by law (guardianship, curator or under judicial protection)
* deprivation of liberty by judicial or administrative decision
* Increased likelihood of non compliance to the protocol or abandonment under study
* pregnancy or breastfeeding
Biology and Treatment Strategy of AML in Its Subgroups: Multicenter Randomized Trial by the German Acute Myeloid Leukemia Cooperative Group (AMLCG)

The study in patients with primary and secondary AML and high-risk MDS uses a risk-stratified, randomized design to evaluate the role of high-dose araC in induction, of G-CSF priming, and of autologous stem cell transplantation.

The present study by the German AML Cooperative Group has been designed in order to investigate the effects of AML typical therapeutic strategies for AML and related diseases. Thus, the entry criteria are age starting from 16 years with no upper age limit, de novo AML or AML secondary to chemotherapy or radiotherapy of another disease or myelodysplasia subtype RAEB with bone marrow blasts greater than 10 %. All randomization is stratified according to karyotype favorable / intermediate / unfavorable. Additional stratification is according to LDH \</\>= 700 U and age \</\>= 60 Y. Standard treatment is (A) double induction with TAD and HAM, consolidation with TAD and maintenance treatment with monthly AD-AT-AC-AT -, rotatingly. Experimental modifications to be compared with stan-dard treatment are (B) double induction with HAM-HAM, (C) multiple course G-CSF before and during chemotherapy courses and (D) instead of maintenance treatment myeloablative consolidation with Bu/Cy and autologous blood stem cell transplantation. Intent to treat conditions are guaranteed by randomization before induction treatment starts. In order to evaluate the effect of every single modification randomization to (C) is equally distributed to the patients in treatment arms (A) and (B) which is also true for the randomization to (D) (balanced randomization). Similarly balanced between treatment arms are the patients according to diagnosis, age and risk factors like serum LDH and karyotype. In order to adapt treatment intensity to age patients of 60 years and older receive the second induction course only in case of 5 % or more residual bone marrow blasts. In addition, the AraC dose in HAM is reduced to 1 instead of 3 g/sqm in this age group. Furthermore, there is no treatment arm including stem cell transplantation in patients of 60+ years. Pri-mary endpoint to compare the therapeutic strategies is event-free survival from treatment start (A, B, C) and from achievement of remission (D), respectively.

By this design the AMLCG 2000 trial can contribute relevant experiences on optimum therapeutic strategies for the biological subgroups of de novo AML, secondary AML and MDS. Furthermore, new biological subgroups and their significance related to treatment strategies can be defined.

Eligibility Criteria:
Inclusion Criteria:

* Acute myeloid leukemia (de-novo AML, secondary AML, high-risk MDS)
* Age 16 - no upper age limit
* Written informed consent

Exclusion Criteria:

* Severe comorbidity
* Presence of other malignancy
* Prior anti-leukemic treatment
* Pregnancy
* Severe psychiatric disorder or other circumstances which may compromise cooperation of the patients
Effect Of Complete Decongestive Therapy On Carpal Tunnel Syndrome Post Upper Limb Lymphedema

this study will be conducted to investigate the therapeutic effect of complete decongestive therapy on carpal tunnel syndrome post-upper limb lymphedema.

lymphedema is a chronic condition characterized by lymphatic vessel ectasia and valve dysfunction, followed by the reflux of lymphatic fluid into the interstitial space. Lymph stasis may lead to a chronic inflammatory process, resulting in adipose tissue differentiation and fibro adipose tissue deposition. One consequence of post-mastectomy lymphedema may be the development of nerve entrapments. One example is median nerve entrapment in the carpal canal, or carpal tunnel syndrome (CTS). many studies assessed the relationship of CTS as a risk factor for developing lymphedema, other studies stated the possibility of lymphedema as a potential contributor to CTS development. Complex decongestive treatment of breast cancer-related lymphoedema is an accepted strategy and is considered as an international standard for treatment. A previous review concluded that complex decongestive therapy has a positive impact on the volume of arm and quality of life in different stages of lymphedema.sixty females will be allocated randomly to two groups; first one will receive decongestive therapy and the second one will receive the routine medical treatment for ten weeks

Eligibility Criteria:
Inclusion Criteria:

* Age will range between 20- 40 years.
* Only females will participate in the study.
* All patients have carpal tunnel syndrome post upper limb lymphedema.

Exclusion Criteria:

* Diabetes mellitus.
* Individuals with cardiopulmonary conditions.
* Individuals undergoing radiation therapy or chemotherapy.
* Hepatic or pancreatic diseases.
* Sensory impairment.
Promoting Healthy Families: A Canadian Evaluation

Interventions that promote safe, stable, and nurturing relationships between caregivers and children are key to improving healthy family relationships, reducing child socioemotional and behaviour problems, and preventing child maltreatment. Although a broad range of parenting programs are currently implemented in communities across Ontario, most programs are inadequately evaluated, or else not evaluated at all. Using a three-armed randomized controlled trial, the aim of the current study is to evaluate the effectiveness of two parenting programs, the Triple P - Positive Parenting Program (group - level 4) and the Circle of Security Parenting Program (group) compared to treatment as usual in Ontario, Canada.

The overall goal of the evaluation is to provide robust evidence about the implementation and effectiveness of two parenting programs, the Triple P and Circle of Security Parenting (COSP), in the province of Ontario, on parenting practices and functioning, and child emotional behaviour problems outcomes, and secondary outcomes including selected child maltreatment-related outcomes. These objectives will be achieved in two phases. The investigators will conduct a multi-site, three-arm randomized controlled trial of 600 participating caregivers and their children to compare Triple P (level 4 group) and COSP to treatment as usual (TAU) with respect to improving positive practices and child outcomes. Participants will be randomly assigned to one of the three conditions using stratified (by site) block randomization. All participants will undergo screening and a baseline assessment before randomization. Once randomized, the Triple P and COSP caregivers will receive 8-week session. The TAU group will receive a different program, or short therapy sessions depending on the organization. Caregivers will complete follow-up assessments at post-treatment, 6- and 12-months.

Eligibility Criteria:
Inclusion Criteria:

Caregivers of children are eligible for inclusion if:

* Custodial caregiver of child is aged 2 to 6 years at time of screening.
* Families with sufficient knowledge of English needed for assessment measures.
* Caregivers capable of giving informed, written consent.
* Definition of 'at-risk' as measured by one of the following criteria as outlined below:

  * Elevated child emotional behavioural problems as indexed by above- population mean total scores on the Strengths and Difficulties Questionnaire (SDQ); OR
  * One of the following family or contextual risk factor
  * Parental challenge - parental mental health problems, as indexed by score on K6 distress scale ≥ 13; adolescent parent status (less than 20 years of age); single parent status; OR Sociodemographic risk factor - parent with less than grade 12 education; parent on social assistance;
  * Expressed difficulties with parenting: Do you often feel like your child is difficult to take care of?

Exclusion Criteria:

• Children with suspected severe to profound developmental delay.
Pulmonary Complications of Allografts

This is a prognostic study of the late lung complications arising at the patient's having received an allograft of hematopoetic stem cells.

* Objectives To estimate the incidence of late (at least occurring 100 days after transplantation) pulmonary complications following allogeneic blood stem cells transplantation
* Study Design Prospective Cohort Study All follow-up data were actualiized in September, 2016.
* Sample Size 200 transplanted patients
* Main Endpoint Non infectious pulmonary complications within the first 3 years

Eligibility Criteria:
Inclusion Criteria:

* Allogeneic Blood stem cell transplantation
* Alive at day 100 post-transplant

Exclusion Criteria:

* Non informed consent
Diagnostic Performance of On-site Automatic Coronary Computed Tomography Angiography-derived Fractional Flow Reserve

The current study evaluated the diagnostic performance for myocardial ischemia of on-site automatic CCTA-derived FFR (CT-FFR) using a commercially available workstation as compared with invasive FFR as a reference. The diagnostic performance of CT-FFR was compared to that of CCTA diameter stenosis.

This is a retrospective, multicenter, comparative, investigator-initiated study to evaluate the diagnostic performance of CT-FFR from routinely acquired CCTA data using the software HeartMedi+ 1.0 (AI Medic, Korea) to detect hemodynamically significant CAD. Patients who underwent CCTA within 90 days before invasive coronary angiography and FFR measurement will be screened in each participating center. After that, invasive coronary angiography, FFR data, and CCTA data will be anonymized and transferred to the independent core laboratories and analyzed in a blind fashion.

The presence of ischemia was defined as FFR ≤0.80. Anatomical obstructive stenosis was defined as diameter stenosis on CCTA ≥50%, and the diagnostic performance of CT-FFR and CCTA stenosis for ischemia was compared.

Eligibility Criteria:
Inclusion Criteria:

* adults aged 20 years or older
* individuals who had undergone ≥ 64 multidetector row CCTA within 90 days before invasive coronary angiography and FFR measurement
* individuals who had not experienced any clinical events or significant clinical changes between the time of CCTA and invasive coronary angiography

Exclusion Criteria:

* previous coronary intervention or coronary bypass surgery in the target vessel
* invasive coronary angiography under unstable conditions
* previous myocardial infarction at target vessel territory
* congenital heart disease
* moderate or severe valvular heart disease
* previous valvular heart surgery
* left ventricular ejection fraction ≤40% or left ventricular hypertrophy
* previous cardiac device implantation
* body mass index \>35 kg/m2
* poor FFR tracing quality
* no information on the position of the FFR pressure wire
* heart rate ≥100 beats/min during CCTA
* CCTA calcium score ≥1000
* no nitroglycerin prior to CCTA
* CCTA slice thickness \>1.0 mm
* significant artifacts in CCTA
Feasibility Study of a New Fistula Pouching System

The purpose of this investigation is to carry out a clinical evaluation of a newly developed fistula pouching system's ability to function as a good pouch for fistulas, with the opening on the skin of the stomach or in a wound on the skin of the stomach.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Capable of giving informed consent
* Have to be hospitalized
* Have a fistula with the opening on the skin in the abdominal area

Exclusion Criteria:

* Pregnant and/or breast-feeding
* Receiving radiation- or chemotherapy during the investigation period