cyrilzakka/clinical-trials huggingface dataset:
Study to Investigate Efficacy and Safety of Adalimumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)

The purpose of this study was to investigate the efficacy, safety, and pharmacokinetics of adalimumab in Japanese participants with generalized pustular psoriasis (GPP) who did not have an adequate response to their currently approved treatment.

This was a Phase 3, multicenter, open-label, single-arm study of adalimumab in Japanese participants with generalized pustular psoriasis (GPP). The study included a 30-day screening period, a 52-week treatment period, and a 70-day follow-up period. The dose regimen of adalimumab used in this study was 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of generalized pustular psoriasis
* Total skin score of at least 3 and erythema with pustules (skin score of at least 1) at baseline in the Japan Dermatology Association (JDA) severity index of Generalized Pustular Psoriasis (GPP) in GPP Medical Care Guideline 2014 in Japan
* Inadequate response to, or intolerance to, or contraindication to the currently approved GPP treatment (excluding infliximab)
* Infliximab secondary failure, or intolerant to infliximab

Exclusion Criteria:

* Erythrodermic psoriasis, guttate psoriasis or sub-corneal pustular dermatosis at Screening
* Drug-induced GPP
* Cannot stop ongoing use of prohibited GPP treatments
* Total JDA severity index of GPP of 14 or more in GPP Medical Care Guideline 2014 in Japan
Nutrition and Neurological Development of Very Preterm Infants

The main goal of this study is to determine, in preterm infants born with a GA \< 32 weeks, the association between:

* the quantity of mother's milk and duration and breastfeeding
* the intake of polyunsaturated fatty acids and iron during hospitalizations

The main hypothesis of this study is that the intake of lipid during hospitalization in neonatology department is associated with neurological development of preterm infants born with a GA \< 32 weeks. The other hypotheses are that iron intake and the duration of breastfeeding are also associated with the development of preterm infants.

In the previous study EPINUTRI (NCT01486173), the development of infants was evaluated until the age of 1 year. EPINUTRI_3 is the follow-up of EPINUTRI until the age of 3 years.

The aim of EPINUTRI_3 study is to determine the association between lipid intake during hospitalization in neonatology department of preterm infants born with a GA \< 32 weeks.

The secondary objective is :

- to evaluate the association between these factors and communication, developmental and social-emotional delays with the test " Ages and Stages questionnaire " (ASQ) at 3 years of age.

Eligibility Criteria:
Inclusion Criteria:

* Premature infants previously included in EPINUTRI study
* Non opposition of the parents for the collection of clinical and nutritional data

Exclusion Criteria:

* Refusal of the parents to collect clinical and nutritional data
The Clinical Practice of Palliative Sedation

Palliative Sedation (PS) is defined as the intentional lowering of consciousness of a patient in the last phase of life, to relieve patients suffering from refractory symptoms. For those symptoms all possible effective treatments, within an acceptable timeframe, are exhausted.

Several studies have been performed about palliative sedation, mostly focusing on continuous deep sedation, with the use of various measurements to monitor its effect. Efficacy of continuous palliative sedation has been monitored by agitation/distress levels, symptom control, levels of sedation/awareness, comfort, safety and family/caregivers satisfaction. Differences between studies occur, for instance in definition, application and monitoring. Consequently reported outcomes and associated treatment goals differ between studies which makes it difficult to compare the results.

Within this international multicenter observational study, the investigators aim to evaluate the effects of palliative sedation on patient's comfort levels. Participants with different forms and intensity of palliative sedation (intermittent and continuous, from light to deep) are included in a prospective design as part of an international study.

Objectives:

1. To evaluate the effect of palliative sedation on participants' comfort and other symptoms in different international hospices, palliative care units and hospital ward settings.
2. To assess the clinical practice of palliative sedation in different international care settings and the accompanying costs and consequences.

Study design: Prospective observational multicentre study in hospices, palliative care units and hospital ward settings in five European countries (Belgium, Germany, Italy, Spain, The Netherlands).


Eligibility Criteria:
Phase 1: Participants are eligible for participation in this study when they meet all the following criteria:

* Adults;
* with advanced cancer;
* and a limited life expectancy (1- 2 months);
* according the health care team, intractable distress caused by one or more refractory symptoms can be expected or is present during the hospitalization.

Participants can enter Phase 2 of this study when fulfilling the following preconditions:

* inclusion criteria for phase 1 are met and informed consent is given by the participant;
* participant is suffering from intractable distress caused by one or more refractory symptoms according the health care team and/or participant and relatives;
* sedative medication is started with the aim to relieve burden of otherwise intractable suffering (palliative sedation)

Exclusion Criteria:

* a potential participant is unable to give informed consent;
* a potential participant is unable to speak and read in the native language of the participating country.
Prediction of Lupus Renal Flares Study

In patients with systemic lupus erythematosus, urinary CD4+ T cells may have the potential to predict subsequent renal flares in the next 6 months. Patients with systemic lupus erythematosus from our outpatient clinic will be included in this cross-sectional, prospective biomarker study regardless of disease activity, clinical phenotype, and disease duration or baseline therapy. Urinary T cells will be analyzed by flow cytometry. 6 months after sample collection a clinical follow-up will be conducted to assess the occurrence of either recurrent or de novo renal flares.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Diagnosis of SLE according to the 2019 EULAR/ACR classification criteria Stable immunosuppressive or biologic background therapy within the last 6 months prior to inclusion

Exclusion Criteria:

* Age \< 18
* Inability to consent
* Urinary tract infection (defined by detection of nitrite or positive urine culture)
* Patients on chronic dialysis
* Concomitant other autoimmune disease
Physiology of Helmet vs. Facemask Noninvasive Ventilation

The optimal noninvasive management of acute hypoxemic respiratory failure is debated. Helmet noninvasive ventilation may be more effective than facemask noninvasive ventilation for these patients. Putatitve benefits of helmet use are the possibility to apply significantly higher positive end-expiratory pressure without air leaks and with good patient's comfort.

In this randomized crossover study, the investigators will assess the physiological effects of helmet compared to facemask noninvasive ventilation, with the latter applied with different ventilator settings (similar to or different from helmet settings).


Eligibility Criteria:
Inclusion Criteria:

* Acute hypoxemic respiratory failure and PaO2/FiO2\<200 mmHg
* PaCO2\<45 mmHg
* Respiratory failure not caused by exacerbation of chronic pulmonary disease, cardiac failure or fluid overload

Exclusion Criteria:

* Pregnancy
* Contraindication to helmet or facemask noninvasive ventilation
* Contraindication to esophageal manometry
* Contraindication to electrical-impedance tomography monitoring
* Recent surgery involving the abdomen or the thorax
* Pneumothorax or documented barotrauma
The Use of the Social Networking to Promote Educational and Consultative Actions Among Kidney Transplanted Adolescents.

This study is designed to compare the knowledge, satisfaction and self-esteem of kidney transplanted adolescents measured through questionnaires between two groups: patients undergoing conventional treatment with no other intervention versus patients undergoing conventional treatment and receiving additional educational and consultative actions using a closed facebook group.

Based on literature, there are strong evidences that the use of social media improves the outcomes of chronic treatments. Currently, there is no study using social media as an education tool in kidney transplant patients in Brazil. This study is designed to answer the question: "Does the use of a popular social media such as facebook improves the knowledge, satisfaction and self-steem levels among kidney transplant adolescents when compared with their peers ?" This is a non-blinded randomized clinical trial. Patients will be randomly included into one of the two groups: the control group who will not receive any intervention or the facebook group (who will receive additional educational and consultative support through a closed facebook group) After three months, knowledge level, satisfaction level and self-esteem will be assessed by specific designed questionnaires and by the application of the Rosenberg's self-esteem scale. The study will have a sample of 122 subjects, equally divided (61 participants in each group). Collected data will be compared using the chi square test.

Eligibility Criteria:
Inclusion criteria

* patients receiving follow up care by the transplant interdisciplinary team either in the pre or in the post transplant period

Exclusion criteria

* patients with chronic kidney disease not enrolled to receive a kidney transplant.
Evaluation of the Predictive Value of Blood Levels of Angiopoietin 1 and Endothelial Internal Tunica Cell Kinase 2 in Patients With Ovarian Cancer Treated With Chemotherapy Associated to Bevacizumab

This is a monocentric prospective observational pilot study of translational research in women with advanced ovarian epithelial cancer. The main purpose of this study is to evaluate the predictive value of response to treatment with bevacizumab of the circulating levels of Ang1, Tie2 and VEGF before start of therapy. Secondary aims of the study are to explore the predictive value of response / resistance to bevacizumab of changes in circulating levels of Ang1 and Tie2 during treatment and at progression of disease, and to explore the possible role of circulating VEGF in the modulation of bioavailability of bevacizumab.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old
* Diagnosis of histologically confirmed advanced epithelial ovarian carcinoma
* Women eligible for treatment with a chemotherapy regimen in combination to bevacizumab (Cohort A)
* Women eligible for treatment with a chemotherapy regimen not associated to antiangiogenic drugs (Cohort B)
* Evaluable disease according to RECIST 1.1 criteria
* Patient informed consent signature prior to any study-specific procedure

Exclusion Criteria:

* History of other malignancy within 5 years prior to study entry (except for cutaneous basal cell carcinoma or adequately treated carcinoma in situ of the cervix ).
Accuracy of Pleth Variability Index (PVI) in Children

Plethysmographic Variability index is a simple index accurate in predicting fluid responsiveness.

The aim of this study was to investigate its accuracy in predicting fluid response to intravenous fluid challenge during scoliosis surgery in children.

The goal of the present study is to assess the validity of PVI in predicting the response to a fluid challenge during scoliosis surgery in children.

During this observational non-interventional study, each fluid challenge will be monitored by esophageal Doppler and PVI (Massimo Radical 5).

Anesthesia, surgery and intraoperative fluid administration id standardized according to our clinical protocol.

An increase in indexed Stroke Volume (iSV) by more than 15 % will define the positive response to the fluid challenge.

Fluid challenges will be performed in the supine position and in the prone position.

Statistical analysis will performed using the Receiving Operator Characteristics (ROC) curve with determination of the gray-zone allowing an error tolerance of 10 %.

Eligibility Criteria:
Inclusion Criteria:

* Scoliosis surgery
* Age \< 18 years

Exclusion Criteria:

* Heart or vascular Diseases
* Rectal abnormalities
* Kidney Failure
* Neuromuscular scoliosis
Communication and Intimacy-Enhancing Therapy for Men With Early Stage Prostate Cancer and Their Partners

RATIONALE: Participating in a therapy program may enhance communication and intimacy between men with prostate cancer and their partners.

PURPOSE: This randomized clinical trial is studying how well therapy enhances communication and intimacy for men with early stage prostate cancer and for their partners.

OBJECTIVES:

Primary

* To evaluate the feasibility and acceptability of conducting a randomized clinical trial evaluating communication and intimacy-enhancing intervention (CI) vs usual care (UC).
* To collect descriptive information and basic psychometrics on proposed study measures.
* To gather preliminary data regarding the impact of CI on couples' psychosocial adaptation, relationship closeness, and sexual intimacy in order to calculate power for a larger full scale trial.

OUTLINE: This is a multicenter study. Patients and their partners are randomized to 1 of 2 intervention arms.

* Arm I: Patients and their partners receive communication and intimacy-enhancing intervention (CI) once a week comprising the following five 90-minute sessions: Rationale and Overview; Basic Communication; Intimacy and Sexuality; Improving Intimacy; and Reflecting on Changes and Cancer Survivorship.
* Arm II: Patients and their partners receive standard psychological and emotional care (usual care \[UC\]) (i.e., social work consultations and referral to a psychiatrist or psychologist, if requested or deemed necessary by the attending physician).

Physical impairment, psychological adjustment, relationship closeness, relationship communication, sexual function and satisfaction, male self-esteem, relationship satisfaction, intervention evaluation, and erectile dysfunction treatment utilization, and referral are assessed at 1 week post-intervention or at 6-8 weeks post baseline and then at 3 months (for patients and their partners in arm I) and at 8 weeks post-baseline and then at 3 months (for patients and their partners in arm II).

PROJECTED ACCRUAL: A total of 50 patients and 50 partners will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Patient has a primary diagnosis of localized (early stage) prostate cancer

  * Has undergone surgery within the past year
* Patient and partner married or cohabiting and relationship duration ≥ 1 year

PATIENT CHARACTERISTICS:

* ECOG performance status 0 or 1 at the time of initial recruitment
* Lives within 2-hour commuting distance from recruitment center (MSKCC or FCCC)
* No significant self-identified hearing impairment that would preclude study participation

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Effects of Pilates Exercises on Dynamic Balance in Elderly Population

To find out the effects of Plates exercises on dynamic balance in elderly population

The process of age-related changes involves some kind of degenerative, gradual changes which are irreversible such as degradation of activity of cells and loss of physical adaptability. According to age-related changes such as changes in balance are specifically begins near the age 45 years-old, physical characteristics such as (flexibility, strength, balance and coordination) and sensory systems are affected which ultimately increase the chances of falls in elderly individuals. Balance can be defined as the ability of a person to control their position within the limits of base of support. Pilates is an individualized-based and low-intermediate intensity exercise that can be easily performed by the elderly . Conventional balance exercises which have rehabilitative effect in reducing risk of falls and enhancing functional ability in elderly population. Conventional balance training comprises of four components which are flexibility exercises, strength training, postural control exercise and endurance training.The objective of the study IS to find out the effects of Pilates exercises on dynamic balance in elderly population. The Twenty-four participants will be recruited and divided into two equal groups randomly. The group A(n=12) will perform Pilates-based exercises protocol for 50- minutes with 10-minutes warm-up phase, 30-minutes training phase and 10-minutes for cool-down phase, thrice a week for four week and the group B(n=12) will receive Conventional balance training exercises for 50-minutes, thrice a week for four weeks. Outcome measures will be were TUG and SPPB before and after the trial and the outcomes will be compared before and end of four weeks treatment protocol. Data will be analyze by SPSS version 21. Independent sample t- test and paired sample t-test will be utilize to compare and evaluate the effects of both approaches.

Eligibility Criteria:
Inclusion Criteria:

* Those who had history of fall in past one year.
* Elderly population who scores 45 on Berg Balance Scale.

Exclusion Criteria:

* Those elderly individuals who are suffering from any kind of disease that can affect their performance for example Osteoarthritis grade III \&amp; IV, scoliosis.
* Those elderly individuals who are suffering from any kind of visual, auditory and neural or vestibular system disorders.
* Those elderly individuals who are unable to understand the treatment protocol.
Comparison of Two Strategies for the Management of Atrial Fibrillation After Cardiac Surgery

Postoperative atrial fibrillation is a common complication after cardiac surgery with a rate of 30%. However, management of postoperative atrial fibrillation is controversial. Two strategies are recommended : heart rate control using a betablocker or rhythm control with amiodarone.

Landiolol is a new-generation beta-blocker with a short half-life, which was approved by the Haute Autorité de Santé to be used in perioperative supra-ventricular tachycardias.

Only one study compared landiolol to amiodarone in the perioperative setting, with a better hemodynamic tolerance and a higher rate of conversion to sinus rhythm with landiolol. However this was a single-center and retrospective study.

The aim of our multicenter randomized study is to compare the effectiveness of landiolol in reducing atrial fibrillation to sinus rhythm compared to amiodarone in the postoperative period after cardiac surgery.

Randomized clinical study comparing landiolol and amiodarone for treatment of atrial fibrillation following cardiac surgery

Eligibility Criteria:
Inclusion Criteria:

* Adult patients hospitalized in the cardiac ICU after having undergone cardiac surgery (CABG, aortic valve or ascending aortic root replacement or a combination of both)
* New onset of atrial fibrillation lasting more than 30 minutes in the postoperative period after cardiac surgery
* French speaking patients
* Written consent
* Patients with social security insurance

Exclusion Criteria:

* Hemodynamic instability requiring electrical cardioversion of atrial fibrillation
* Sepsis
* Bradyarrythmia (\< 90/min)
* Patients requiring inotropes in the postoperative period
* Patient with pre-existing atrial fibrillation
* Patient with anticoagulant therapy before surgery
* Contraindication to amiodarone or beta-blockers
* Urgent surgery (\< 24h), ventricular assist device, heart transplant, TAVR, mechanical valve, mitral or tricuspid valve replacement.
* No written consent
* Pregnant women,
* Underaged patients (\<18 years old)
* Patients not able to give consent (curators, patients deprived of public rights)
Conséquences of the COVID-19 Lockdown Measures on the CHRU Nancy Pediatric Emergency Services

The first period of COVID 19 Lockdown Measures (From 18 March to 11 may 2020) change the French people way of life and their medicine knowledges. A study which evaluates the Nancy's Pediatric emergencies population utilization during this time could detect pathological changes. The medical impact of Home Confinement will show an increase (trauma, maltreatment) or decrease (virus disease) of several pathology. The study aims to help clinicians to the children care if another time of Home Confinement happened. The main objective is to evaluate the behavioural changes and the reason consultation in Nancy's Pediatric Emergencies from 18 March to 30 June 2020 comparate to the same time in 2019. We will continue the search after the end of Home Confinement until 30 June 2020 to evaluate what happened just after.


Eligibility Criteria:
Inclusion Criteria:

* children who are cared during the study period to the Nancy's pediatric emergencies

Exclusion Criteria:

* be more than 18 years old
* Not being seen by a doctor
A European Network for the Investigation of Gender Incongruence

The physical and psychological effects of the hormonal treatment of transsexual persons are not sufficiently described. 'Transparency' wants to answer this question in a prospective manner, in a multicenter study to describe these effects. The low prevalence of transsexualism was the stimulus to search for European partners for this Protocol. A common standardized hormonal protocol was designed.


Eligibility Criteria:
Inclusion Criteria:

* Transsexual persons older then 18 years, who are not yet treated with hormonal therapy.

Exclusion Criteria:

-
Early Access Program of Lazertinib in Republic of Korea

This early access program will be conducted to provide access to Lazertinib for adult patients with locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) with T790M mutation-positive after 1st/2nd generation EGFR TKIs Therapy.

Lazertinib is an oral, highly potent, mutant-selective and irreversible EGFR Tyrosine-kinase inhibitors (TKIs) targets both the T790M mutation and activating EGFR mutations while sparing wild type-EGFR.

This is a Multi-center, Prospective, Early Access Program of Lazertinib in locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) patients with T790M mutation-positive after 1st/2nd generation EGFR TKIs therapy to assess the safety and efficacy of real world evidence as second-line treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged at least 19 years
* Patients who have written consent for use of personal and medical information for the study purpose
* Patients who are prescribed and administered with approved indication for Lazerinib in Korea and not been treated with Lazertinib previously.

Exclusion Criteria:

* Patients with hypersensitivity to Lazertinib or its any ingredients
* Patients who belong to contraindication listed on lazertinib label in Korea
* Patients who are treated for an indication not approved for the use of Lazertinib
* Women who are pregnant or may possibly become pregnant