cyrilzakka/clinical-trials huggingface dataset:
Acceptance and Commitment Group Therapy for Unaccompanied Minors

Unaccompanied minors (UM) are considered to be a highly vulnerable refugee subgroup. Research has indicated that UM experience traumatic events and consequently develop high levels of psychopathology. Post-traumatic stress disorder is the most prevalent diagnosis, followed by depression, anxiety disorders as well as traumatic grief and conduct problems. Acceptance and Commitment Therapy (ACT) may be particularly suited to the treatment of survivors of trauma and with vulnerable refugee groups such as UM. A 5-week ACT group intervention will be carried out and its feasibility in UM will be explored along with its effect on mental health. The ACT group intervention will be based on a Self-Help Booklet by the World Health Organization "Doing What Matters in Times of Stress: An Illustrated Guide". Following the 5-week ACT group intervention, focus groups with participants will be carried out to examine its acceptability and will be analysed qualitatively, using thematic analysis.

The hypotheses of the study are as follows:

1. The ACT group intervention will lead to increases in UM psychological well-being and quality of life compared to a waiting-list (WL) control group. This includes improvements in post-traumatic stress symptoms, depression, anxiety, stress, and sleep difficulties. (Primary outcomes).
2. The UM receiving the ACT group intervention will demonstrate improvements in their prosocial behaviour compared to the WL control group. (Primary outcomes).
3. At post-intervention, UM receiving the ACT group intervention will have enhanced psychological flexibility compared to the WL control group. It is predicted that there will be decreased experiential avoidance and cognitive fusion, coupled with increases in values-driven committed action, present moment awareness and self-as-context. (Secondary outcomes).
4. At the 1-month and 3-month follow-up time points, the UM receiving the ACT group intervention will have retained the improvements from the treatment (i.e., increased psychological wellbeing, enhanced psychological flexibility, augmented prosocial behaviour) compared to the WL control group. Additionally, it is predicted that UM who completed the ACT group intervention will not only have sustained the benefits observed directly post-intervention but will in fact keep making progress at follow-up time points compared to the WL control group.

From the qualitative analysis, the investigators presume to provide critical insights as to what is perceived acceptable and culturally appropriate treatment for this population.

Eligibility Criteria:
Inclusion Criteria:

* Unaccompanied refugee minors living in sheltered accommodation in Cyprus.
* No specific diagnosis required to take part in the study.
* No specific cultural background required.
* Minors who provide consent.

Exclusion Criteria:

- Presence of active psychosis.
Outcomes of Vitrectomy in Pediatric Retinal Detachment With Proliferative Vitreoretinopathy

The aim of this study is to report outcomes of pars plana vitrectomy (PPV) in pediatric retinal detachment (RD) accompanied with proliferative vitreoretinopathy (PVR) as well as complications and factors influencing the final anatomical and functional results.

This is retrospective consecutive case series of 14 eyes treated with primary PPV for RD repair. Average postoperative follow-up period is 34 months.

This is the retrospective study of 14 consecutive patients younger than 18 years age who underwent primary PPV at the Department of General Ophthalmology of Medical University of Lublin in a time period from 1st January 2006 to 1st January 2017. This study followed the tenets of the Declaration of Helsinki. The treatment chosen in the study was a part of a standard care. Written informed consent was taken from all subjects. All patients underwent vitreoretinal surgery due to RD (rhegmatogenous, tractional or combined rhegmatogenous and tractional). Exclusion criteria from the study was the time of follow-up less than 6 months.

Average age at the time of the presence of RD was 10±4.7 years (range 4-17 years). Pre- and postoperative data were collected. Descriptive statistical analysis included gender, age at the presentation, laterality, etiology, duration of presenting symptoms, presences of ocular comorbidities, macular status (attached or non-attached), presence of PVR grade C, initial and final best-corrected visual acuity (BCVA), number of procedures, type of endotamponade during PPV, final lens status, duration of the follow-up, anatomical success and complications. Indications for PPV were as follows: presence of advanced PVR and/or total RD and/or multiple breaks, giant retinal tears. PVR was graded according to the Retina Society Terminology Classification \[9\]. Visual acuity was measured by Snellen charts. The anatomical success was defined as persistent retinal reattachment at the last follow-up visit (regardless of presence or absence of silicone oil tamponade).

Statistical computations were performed using STATISTICA 13PL (Stasoft, USA) programme.

Eligibility Criteria:
Inclusion Criteria:

* patients younger than 18 years age who underwent primary PPV at the Department of General Ophthalmology of Medical University of Lublin in a time period from 1st January 2006 to 1st January 2017

Exclusion Criteria:

* age up to 18 years old
Remediation of Schizophrenia Sensory Gating Deficit With Aripiprazole

The purpose of this study is the use of magnetoencephalography or MEG (a machine that measures magnetic activity in your brain) and electroencephalography or EEG (a technique that measures electrical activity in your brain) to study how sounds are processed in individuals with schizophrenia prior to initiation with aripiprazole treatment and after three months of taking the antipsychotic medication aripiprazole.

Problems with attention and perception are core features of schizophrenia and are hypothesized to result from defects in the filtering or gating of sensory input. Examination of this requires neuroimaging techniques with high temporal resolution. High-density EEG and MEG in combination with structural magnetic resonance imaging (sMRI) are used to map sensory gating. In a number of recent studies patient treated with novel antipsychotics have been shown to have P50 gating ratios resembling those of normal controls rather than that of schizophrenia subjects treatment with conventional antipsychotics. To date, there is no literature on the effects of aripiprzole on sensory gating. Subjects who meet all inclusion criteria will receive a clinical interview, an MRI, MEG, and neuropsychological testing before starting treatment with aripiprazole and again 3 months later to determine if patients with schizophrenia who are treated with aripiprazole will demonstrate a sensory gating ratio similar to normal controls, indicating no deficit in sensory gating

Eligibility Criteria:
Inclusion Criteria:

Patient Population

* Diagnosis of Schizophrenia as determine by the Structured Clinical Interview for DSM-IV
* no comorbid diagnosis of PTSD
* continuous treatment with a conventional antipsychotic, risperidone or olanzapine for at least 3 months
* absence of psychiatric hospitalization for at least 3 month
* no history of drug dependency in their lifetime
* no history of alcohol or other substance abuse in the 6 months prior to entry into the study
* no history of head injury with loss of consciousness for more than 5 minutes
* no history of seizure disorder
* no mood stabilizing agents
* between 18-65 and
* able to sign informed consent

Normal Controls

* Matched in age and gender to patient population
* No history of psychiatric dysfunction or alcohol or other substance dependence in their lifetime as determine by the SCID
* No history of alcohol or other substance abuse in the previous 6 months
* No family history of psychotic disorder in first degree relatives as assessed by the FH-RDC diagnostic interview
* No history of head injury with loss of consciousness for more than 5 minutes
* No history of seizure disorder
* Between 18-65
* Able to sign informed consent

Exclusion Criteria:

Subjects will be excluded from participating in this study if they:

* Require treatment with a mood stabilizer
* Have had an inpatient hospitalization in the past 3 months\\
* Have a history of a neurological disorder
* Have any other axis I diagnosis besides schizophrenia
The Partners Scale-Up Project

An implementation project to scale-up delivery of antiretroviral-based HIV-1 prevention methods to Kenyan HIV-1 serodiscordant couples in HIV-1 care centers. Pre-exposure prophylaxis (PrEP) as a bridge to antiretroviral therapy (ART) HIV-1 prevention strategy will be introduced into 24 public HIV-1 care centers in central and western Kenya according to national guidelines using a stepped wedge design, stratified by region.

PrEP as a bridge to ART strategy will be introduced into 24 Kenyan public HIV-1 care centers according to national guidelines, in staged fashion, stratified by region (a stepped wedge design). Monitoring and evaluation activities will identify implementation barriers and solutions, characterize costs, and provide best practices for further scale-up. A research component will establish prospective open cohorts of couples at each clinic (up to 200) to study how the program is effectively implemented. Follow-up in the cohorts will be for up to 36 months at each care center and will evaluate impact, costs, and facilitators and barriers to implementation at patient, provider and health system levels.

Eligibility Criteria:
Inclusion Criteria:

* For HIV-1 uninfected members of the couple
* Age ≥18
* Able and willing to provide consent for follow-up in the cohort
* HIV-1 uninfected based on negative HIV-1 tests, per Kenya national guidelines
* Not currently using PrEP

For HIV-1 infected members of the couple

* Age ≥18
* Able and willing to provide consent for follow-up in the cohort
* HIV-1 infected based on positive HIV-1 tests, per Kenya national guidelines
* Not currently using ART

For both members of the couple - Meet criteria for initiating PrEP as per Kenya national guidelines, including:

* HIV-1 infected member not currently using ART, on ART \<6 months, or on ART but not virally suppressed based on a viral load test done at the clinic as per Kenya national guidelines or
* Trying to conceive

For key delivery informants

- Able and willing to provide consent

Exclusion Criteria:

* Otherwise not eligible based on the above inclusion criteria
A Canadian, Multi-centre, Observational Registry to Study Adherence and Long Term Outcomes of Therapy in Pediatric Subjects Using SAIZEN® Via Easypod™ Auto-injector for Growth Hormone Treatment

This is a Canadian, Multicentre, Observational Registry to study Adherence and Long Term Outcomes of Therapy in paediatric subjects using Easypod™ electromechanical device for growth hormone treatment from hospital and to assess the level of adherence of subject receiving SAIZEN® via Easypod™ .

Subjects will be enrolled in a multicenter, longitudinal observational registry. Parents/subjects will provide their Informed Consent/assent to upload their data for populationbased analyses and optionally to adhere to a patient adherence support program designed to improve their adherence and, ultimately, clinical outcomes. Adherence data will be primarily derived from the Easypod™ device combined with physician data entry of outcome measures. Data will be collected retrospectively and prospectively. This will allow the establishment of adherence profiles and explore the hypothesis that patient adherence support programs improve adherence and subsequent clinical outcomes. Collected data will be also analyzed in a multinational pooled analysis of comparable national studies.

Primary Objective:

- To assess the level of adherence of subjects prescribed SAIZEN® via easypod™

Secondary Objectives:

* To describe the impact of adherence on clinical outcomes for subject prescribed SAIZEN via easypod™
* To identify adherence subject profiling

Eligibility Criteria:
Inclusion Criteria:

* Prescribed SAIZEN® via the easypod™ auto-injector (SAIZEN® Health Canadian approved indications: Growth Hormone Insufficiency or Deficiency, Turner's Syndrome, Chronic Renal Failure, Small for Gestational Age
* Under 18 years of age, or over 18 without fusion of growth plates
* Parent's or legal guardian's written informed consent, given before entering data into the registry, with the understanding that the subject or parent/legal guardian may withdraw consent at any time without prejudice to future medical care. If the child is old enough to read and write, a separate assent form will be given as defined by Health Canada regulations. Adult consent is defined at 18+ in the province of Quebec, 16+ in the remainder of Canada.

Exclusion Criteria:

* Subjects taking growth hormone in whom growth plates have fused (i.e. for taking growth hormone for its metabolic effects)
* Contra-indications to SAIZEN® as defined in SAIZEN® Canadian Product Monograph.
* Use of an investigational drug or participation in another interventional clinical study
Effects of EED on Zn Absorption and Retention in Children From a Standard Dose

The overall objective is to determine the impact of EED on zinc absorption and homeostasis, and its impact on the absorptive capacity of vitamin A absorption of young children (18-24 months of age) in an austere setting with high rates of diarrhea, stunting, and micro-nutrient deficiencies.

Participating children are screened for EED using the lactulose:mannitol ratio test and assigned to one of two groups: +EED or -EED. All participants will be given standard, physiological dose of 3 mg zinc sulfate with a zinc stable isotope tracer on study day 8.

On study day 11, 0.5 mg of 13C10-retinyl-acetate will be administered orally to all participants.

Spot urine samples will be collected twice daily from study days 11-14. Complete fecal collections will be obtained for days 11-14. Duplicate diets of all foods consumed will be collected on days 11-14. On study day 14, a blood sample will be taken for analysis of vitamin A isotope status.

Eligibility Criteria:
Inclusion Criteria:

* Absence of apparent health problems that would impair ability to consume regular diet, to tolerate zinc supplements, or to comply with demands of metabolic studies
* Length for age Z-score (LAZ) between -1.5 to -3.0
* Hemoglobin (Hgb) ≥ 8

Exclusion Criteria:

* Outside age range
* Hgb \< 8
* Chronic illness
* Recent diarrhea (within past 2 weeks, treated with supplemental zinc)
* Severe stunting and/or severe acute malnutrition (SAM): LAZ \<-3; Weight-for-age Z-score (WHZ) \<-3 or mid-upper arm circumference (MUAC) \< 115 or edema
MYL-1402O Compared With Avastin®, in Patients With Stage IV nsNSCLC

Assess the Efficacy and Safety of MYL-1402O Compared with Avastin®, in the First-line Treatment of Patients with Stage IV Non-Squamous Non-Small Cell Lung Cancer

MYL-1402O is a monoclonal antibody currently being developed by Mylan GmbH, as a proposed biosimilar to European Union and US licensed Avastin (hereafter referred to as Avastin), which is approved as first line treatment in combination with carboplatin and paclitaxel (CP) for patients with Stage IV unresectable, recurrent or metastatic nsNSCLC. This randomized equivalence study is designed to meet the global regulatory requirement for approval of a biosimilar product. For this study, both MYL-1402O and Avastin are considered investigational medicinal products (IMP).

Eligibility Criteria:
Key Inclusion Criteria:

1. Written and signed informed consent
2. Male or female at least 18 years of age with documented imaging diagnosis of Stage IV unresectable, recurrent or metastatic nsNSCLC with at least one measurable lesion as defined by RECIST 1.1
3. Documented histologic or cytologic diagnosis of advanced nsNSCLC with negative or unknown sensitizing epidermal growth factor receptor (EGFR) mutation, and negative or unknown echinoderm microtubule-associated protein like 4 anaplastic lymphoma kinase (EML4 ALK) rearrangement.
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
5. Has not received any prior systemic therapy for first-line treatment of advanced lung cancer, except adjuvant chemotherapy, and remained disease-free for at least 12 months from time of surgery, and at least 6 months from last dose of chemotherapy.
6. Treated and stable brain metastasis.

Key Exclusion Criteria:

1. Documented squamous NSCLC or small cell type or large cell neuroendocrine histology
2. History of significant hemoptysis, central tumors with proximity to large vessels and tumor with cavitation
3. Received prior treatment with paclitaxel, bevacizumab or anthracycline or had known hypersensitivity to any of these components.
4. Recent significant cardiac condition or vascular event or inadequately controlled hypertension.
5. On anticoagulant therapy not considered stable
6. Risk of hemorrhage in the central nervous system
7. Recent history of surgery, nonhealing wound, active ulcer, or untreated bone fracture.
8. History of gastrointestinal fistula, perforation, or abscess.
Tocolysis in the Management of Preterm Premature Rupture of Membranes Before 34 Weeks of Gestation

The purpose of this study is to assess whether short-term (48 hr) tocolysis reduces perinatal morti-morbidity in cases of PPROM at 22 to 33 completed weeks' gestation.

Preterm premature rupture of membranes (PPROM) complicates 3% of pregnancies and accounts for one-third of preterm births. It is a leading cause of neonatal mortality and morbidity and increases the risk of maternal infectious morbidity. In cases of early PPROM (22 to 33 completed weeks' gestation), expectant management is recommended in the absence of labor, chorioamnionitis or fetal distress. Antenatal steroids and antibiotics administration are recommended by international guidelines. However, there is no recommendation regarding tocolysis administration in the setting of PPROM. In theory, reducing uterine contractility should delay delivery and reduce risks of prematurity and neonatal adverse consequences. Likewise, a prolongation of gestation may allow administering a corticosteroids complete course that is associated with a two-fold reduction of morbidity and mortality. However, tocolysis may prolong fetal exposure to inflammation and be associated with higher risk of materno-fetal infection, potentially associated with neonatal death or long-term sequelae, including cerebral palsy.

The purpose of this study is to assess whether short-term (48 hr) tocolysis reduces perinatal morti-morbidity in cases of PPROM at 22 to 33 completed weeks' gestation.

Eligibility Criteria:
Inclusion Criteria:

* Preterm premature rupture of membranes (PPROM) between 220/7 - 336/7 weeks of gestation, as diagnosed by obstetric team
* Singleton gestation
* Fetus alive at the time of randomization (reassuring fetal heart monitoring)
* 18 years of age or older
* French speaking
* Affiliated to social security regime or an equivalent system
* Informed consent and signed

Exclusion Criteria:

* PPROM ≥ 24 hours before diagnosis
* Ongoing tocolytic treatment at the time of PPROM
* Tocolytic treatment with Nifedipine between PPROM diagnosis and randomization
* Fetal condition contraindicating expectant management including chorioamnionitis, placental abruption, intrauterine fetal demise, non-reassuring fetal heart rate at the time of randomization
* Cervical dilation \> 5 cm
* Iatrogenic rupture caused by amniocentesis or trophoblast biopsy
* Major fetal anomaly
* Maternal allergy or contra-indication to Nifedipine or placebo drug components\*:

  * Myocardial infarction
  * Unstable angina pectoris
  * Hepatic insufficiency
  * Cardiovascular shock
  * Beta blockers

placebo drug components: lactose monohydrate, colloidal silica, microcrystalline cellulose

* Coadministration of diltiazem or rifampicin
* Hypotension (systolic pressure \< 90 mmHg)
* Participation to another interventional research (category 1) in which intervention could interfere with TOCOPROM's results (efficacy and safety)
Self Directed Positive Parenting Program (Triple P) for Psychosis: A Clinical Case Series

The aim of the case series study is to explore if a self directed version of the Positive Parenting Program (Triple P) is a feasible and acceptable intervention for individuals with psychosis who are parents.

As above.

Eligibility Criteria:
Inclusion Criteria:

* 1. Parents/caregivers (mothers or fathers) with a Schizophrenia-spectrum diagnosis who are:

  2. Aged 18 years or more

  3. Have at least one child aged 3-10 years old

  4. Have a least 10 hours contact time per week with the child.

  5. Identify difficulties in parenting during assessment

Exclusion Criteria:

* 1. Parents/caregivers and family members who do not have good working knowledge of English. They should have enough practical experience to be able to adequately use the English language to understand and respond to questions, to read and complete questionnaires

  2. Families who do not have at least one adult who has basic literacy skills

  3. Families where there is known intention for their children to be taken into care or where the parent(s) have no regular contact with the index child

  4. Parents with a clinical schizophrenia-spectrum diagnosis who have recently been discharged from acute in-patient care for their condition and have less than four weeks of stabilisation of psychotic experiences (operationally defined as no significant change to management or severity of symptoms in a four-week period since discharge as assessed from case notes). This is because if a potential parent with schizophrenia had recently required an inpatient stay, it is important to give them sufficient time to readjust to living in the community and ensure sufficient time is provided for symptom stabilisation before taking part

  5. Families seeking support from services regarding child management issues

  6. Families actively involved in another current cognitive behavioural therapy based intervention
Negative Pressure Wound Therapy -PREVENA in Prevention of Infections After Total Knee Arthroplasty (TKA)

This trial is a prospective, single center, unblinded, randomized, controlled study to assess the safety and efficacy of negative pressure wound therapy in preventing infections after TKA surgery . The study will enroll 316 patients that will undergo TKA. patients will be randomized to the treatment group and undergo the study intervention - (NPWT) The intervention will take place at the end of the surgery. The Patients that are randomized to the control group will receive standard treatment. Both groups will be assessed at two weeks and six weeks. period.


Eligibility Criteria:
Inclusion Criteria:

* Ages: 18 to 80
* Males- not involved in active military duty.
* Females-non child bearing potential, or females of child-bearing potential who have a negative pregnancy test (hCG urine) within 72 hours of informed consent.

Exclusion Criteria:

* Active systemic or local infection.
* History of malignancy, radiotherapy, or chemotherapy for malignancy (except BCC of the skin)
* Active autoimmune disease.
* Any past or present immunosuppressive treatment.
* Current treatment with chemotherapeutic agents
* History of metabolic bone disease (primary or secondary).
* Chronic renal insufficiency (defined by 50% increase of normal levels).