cyrilzakka/clinical-trials huggingface dataset:
Randomized Control Trial of Group Intervention With Former War-affected Boys in the Democratic Republic of Congo

The purpose of this study is to evaluate, in a randomised control trial (RCT), the effectiveness of group-based, trauma-focused Cognitive Behaviour Therapy (TF-CBT) in reducing psychological distress in former child soldiers and other war-affected children in the Democratic Republic of Congo (DRC).

To the best of the author's knowledge this is the first group-based mental health or psychosocial intervention developed specifically for psychologically distressed former child soldiers. While CBT is the modality with most empirical evidence for treating war-affected young people, this is the first evaluation with child soldiers specifically.

Former child soldiers and war affected 'street boys' (aged 13-17) in eastern DRC, will be screened for symptoms of psychological distress and then randomly assigned to either a treatment group or a waiting-list control. The treatment groups will receive a 15-session manualised, culturally-adapted, TF-CBT intervention. This includes psycho-education, relaxation, affect modulation, cognitive processing and constructing a trauma narrative. After treatment and post-testing, the waiting-list controls then begin their intervention.

Eligibility Criteria:
Inclusion Criteria:

* War-affected children and adolescents

Exclusion Criteria:

* No traumatic war events experienced
* Psychosis
* Inability to speak Swahili, French or English
Intensified Rituimab Prephase Before FCR in Untreated B-CLL

Phase II, multicenter, randomized trial, exploring intensified Rituximab prephase monotherapy before standard Fludarabine-Cyclophosphamide-Rituximab FC-R regimen in previously untreated symptomatic B-cell chronic lymphocytic leukemia CLL.

A Study from the Goelams GCFLLCMW intergroup

Young fit medically B Cell untreated patients Comparison between FCR treatment = 6 FCR cycles and a the addition of a prephase with R Dense treatment before the 6 FCR cycles.

Eligibility Criteria:
Inclusion criteria:

* Patient information and written informed consent
* 18 years \< Age \< 66 ans
* confirmed B-CLL Matutes score 4 or 5
* Binet stage C or Binet stage A and B with active disease could be considered for inclusion. For stage A with active disease an agreement of investigator coordinator is required.
* no prior treatment except steroids for less than 1 month (detail corticoid)
* No 17p deletion as assessed by FISH \< 10 % positive nuclei
* Performance status ECOG \< 2
* CIRS Cumulative Illness Rating Scale \< 6

Exclusion criteria:

* Binet stage A without active disease according to IWCLL 2008 criteria
* Know HIV seropositivity
* Hepatitis B or C seropositivity unless clearly due to vaccination
* Life expectancy \< 6 months
* Clinically significant auto-immune anemia
* Active second malignancy currently requiring treatment (except basal cell carcinoma in situ endometrial carcinoma and incidental prostate carcinoma) and/or less than 5 years CR after breast cancer
* Any severe co-morbid conditions such as Class III or IV heart failure, myocardial infarction within 6 months, unstable angina, ventricular tachyarythmias requiring ongoing treatment, severe chronic obstructive pulmonary disease with hypoxemia, uncontrolled diabetes mellitus, or uncontrolled hypertension
* Concomitant disease requiring prolonged use of corticosteroids \> 1 month
* Known hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the study drugs According to the SmPC or investigator practice
* Contraindication to use of Rituximab
* Transformation to aggressive B-cell malignancy e.g. diffuse large cell lymphoma, Hodgkin lymphoma, or prolymphocytic leukaemia
* Active bacterial, viral or fungal infection
* Abnormal renal function with creatinine clearance \< 60 ml/min calculated according to the Cockcroft and Gault formula
* Total bilirubin, gamma glutamyltransferase or transaminase levels \> 2.5 ULN.
* Any coexisting medical or psychological condition that would preclude participation in the required study procedures
* Patient with mental deficiency preventing proper understanding of the requirements of treatment.
* Pregnant or breastfeeding women.
* Adult under law-control
* Fertile male and female patients who cannot or do not wish to use an effective method of contraception, during and for 12 months after the final treatment used for the purposes of the study.
* No afiliate to social security
Benefits of Empagliflozin in Patients With Heart Failure and Reduced Ejection Fraction Without Diabetes Mellitus

The study is a short to mid-term randomized single-blind placebo controlled study that aimed to detect the effects of empagliflozin (a sodium-glucose cotransporter-2 inhibitor) compared to placebo on LV end-diastolic and end-systolic volumes, LV ejection fraction, N-terminal pro-B-type natriuretic peptide (NT-proBNP), functional capacity and quality of life (QoL) among non-diabetic patients with HFrEF.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory non-diabetic adult male and non-pregnant female patients with established diagnosis of heart failure (HF) New York Heart Association functional class II-IV and left ventricular ejection fraction (LVEF) ≤ 40% (calculated by echocardiography within the previous 6 months before randomization).
* Patients should have stable symptoms and stable guideline-directed medical therapy for HF within the last 3 months before randomization. It was mandatory that all patients have reached the maximum tolerated doses of guideline-directed medical therapy for HF and are regular on them for at least 3 months before participation.
* Patients were not known to be diabetic and have no history of diabetes remission and their baseline glycosylated hemoglobin (HbA1c) should have been \< 5.7%.
* Patients have never been on SGLT2 inhibitor therapy before.
* Estimated glomerular filtration rate (eGFR) should have been ≥ 45 mL/min/1.73 m² using the chronic kidney disease Epidemiology Collaboration (CKD-EPI) creatinine equation (2009)

Exclusion Criteria:

* Women who were pregnant at time of selection, possibly pregnant, breast-feeding, or planning to become pregnant during the study period.
* Patients who had acute coronary syndrome, cardiac surgery, stroke or transient ischemic attack (TIA) within the last 3 months before randomization.
* Patients who had infiltrative cardiomyopathy, muscular dystrophies, hypertrophic cardiomyopathy, peripartum cardiomyopathy, pericardial restriction or chemotherapy induced cardiomyopathy within 12 months before randomization.
* Patients with severe valvular heart disease.
* Patients who had acute decompensated HF or were on continuous parenteral inotropic agents with 3 months before randomization.
* Patients who had cardiac resynchronization therapy (CRT) implantation within 3 months before randomization.
* History of recurrent urinary tract infection, cancer or any life threatening condition or psychiatric disease incompatible with being in the study.
Six Months Follow-up of Two and Four Mini Screws Supported Hyrax in Adults

six months follow-up of two and four mini-screw supported hyrax for maxillary expansion in non-growing patients: A randomized controlled clinical trial

transverse malocclusion is very common in adult ,using conventional hyrax expander has many limitations and side effects such as buccal tipping, marginal bone loss, dento aloveolar expansion.

in such cases , surgically assisted rapid palatal expansion used to be the option of choice ,due to the invasiveness of the procedure and co-morbidity associated with it ,minis crews assisted rapid expansion is recently introduced to overcome the complications of both convectional and surgically assisted rapid palatal expansion

Eligibility Criteria:
Inclusion Criteria:

* adults male or female aged from 18-30 years with skeletal Maxillary constriction.
* unilateral or bilateral Dental posterior cross-bite.
* mid-palatal suture maturation (Grade C, D) according to F Angileri classification.
* good oral hygiene,

Exclusion Criteria:

* no functional crossbite due to premature contacts.
* no previous orthodontic treatment.
* no buccal crossbite.
* no craniofacial anomalies or syndromes
Cardiac Resynchronization Therapy, Dyspnea and Exercise Tolerance in Patients With Congestive Heart Failure (CHF)

A new therapy for patients with advanced heart failure (HF) involves the implantation of a specialized pacemaker device (Cardiac Resynchronization Therapy, CRT) that attempts to restore the synchronized contraction of the ventricular chambers of the heart. In some people, CRT improves exertional breathlessness and allows them to exercise for longer periods. However, to date, the mechanisms by which CRT improves symptoms and exercise tolerance is unknown. This study will use in-depth cardiopulmonary exercise testing and pulmonary function testing to explore these mechanisms in greater detail.


Eligibility Criteria:
Inclusion Criteria:

* clinically stable
* being considered for implantation of biventricular pacemaker for CRT
* LVEF \<35%
* QRS duration \>120 msec
* NYHA III-IV functional class
* optimized pharmacologic management of CHF
* no recent (\<1 month) episodes of decompensated CHF

Exclusion Criteria:

* inability to perform cycle ergometry or comply with testing
* uncontrolled ischemic heart disease
* coronary revascularization within 3 months of study entry
* concurrent primary lung disease
* current use of ambulatory oxygen
* rhythm other than sinus
* dependency on pacemaker therapy as a consequence of bradyarrhythmias
* severe valvulopathy
Phrenic Identification in the ICU

This will be a prospective observational study where the investigator will scan patients' necks with an ultrasound and look for anatomical landmarks that may help identify the phrenic nerve.

Patients under protective mechanical ventilation, an intervention that saves lives, may need sedation and paralyzing agents. However, sedation and paralyzing agents are associated with multiple complications, including diaphragm dysfunction.

Several strategies have been proposed to reduce diaphram dysfunction. A novel approach is to stimulate the phrenic nerve, either transvenously or transcutaneously. Transvenous stimulation requires a catheter, which eventually is associated with increased risk of infection and thrombosis. In this scenario, transcutaneous phrenic nerve pacing is attractive but may be more susceptible to patients' anthropometric measures.

The correlation between patients' anthropometric measures and the location of the phrenic has been poorly studied.

Eligibility Criteria:
Inclusion Criteria

* Age ≥ 18 years
* Admitted to ICU

Exclusion Criteria

* Patients with a cervical spine collar
* Patients who refuse to participate in the study
Local Surgery for Metastatic Breast Cancer

Primary treatments for metastatic breast cancer are chemotherapy and radiation therapy, and surgery is reserved for tumor related complications such as bleeding. Retrospective studies showed that surgical removal of the primary tumor improves survival of patients with metastatic breast cancer at diagnosis. We hypothesis and testing that surgical removal of the primary tumor will lead to an improvement of overall survival

This is a randomised, controled clinical trial. Our aim is to observe whether primary surgery improves survival in metastatic breast cancer. Women who have metastatic breast cancer at the initial diagnosis will be included in the study. There will be two study arms: primary surgery and systemic chemotherapy groups.

In the primary surgery group patients will have adjuvant therapies after they had the proper surgery. In the systemic chemotherapy group patients will be followed after their initial therapy and will have surgery only if they have locoregional problems (such as wide necrosis or bleeding, etc). During the follow-up period, patients will be seen in every 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Women with metastatic breast cancer at the initial diagnosis

Exclusion Criteria:

* Women needs breast surgery at the time of initial diagnosis (such as bleeding, necrosis, etc)
* who have systemic morbidity that do not allows her to be in the trial,
* who have synchronous breast cancer at the contralateral breast,
* who have a previous cancer history or another primary cancer history and metastasis at the past,
* who have palpable lymph node/nodes at the contralateral axilla,
* who do not agree to participate the trial
A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer

This is a Phase I, multicenter, open-label, dose escalation and dose expansion study to assess the safety and pharmacokinetic profile of PLB1004, a mono-anilino-pyrimidine compound, given alone in NSCLC patients with EGFR exon 20 insertion mutations，uncommon mutations, classical mutations (Ex19del and L858R), and drug-resistant mutation (T790M). Patients will be enrolled and dosed according to the most current protocol. This study is made of two Parts. Part 1 includes a dose escalation into 7 cohorts and patient allocation to these cohorts will be via slot allocation. Each cohort has a minimum of 3 and a maximum of 6 patients for a total of 21 - 42 patients. The patient population of the dose escalation phase will include patients with advanced NSCLC harboring EGFR classical mutations or Ex20ins mutations, or uncommon mutations. Part 2 includes an expansion phase and the expansion phase will explore one or more dose levels of PLB1004 in NSCLC patients with EGFR Ex20ins mutations, classical mutations, or uncommon mutations.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand and willingness to sign a written informed consent document;
2. Male or female adult patients 18 years of age or older;
3. Patients should have recovered from toxicities related to prior anti-tumor therapy;
4. Patients should have recovered from the effects of major surgery;
5. Have a documented EGFR mutation by a local test in tissue or plasma;
6. At least 12 weeks life expectancy;
7. Must have at least one measurable lesion per RECIST v 1.1;
8. Sexually active males and females of childbearing potential must agree to take effective contraceptive measures.

Exclusion Criteria:

1. Received radiotherapy within 14 days before enrollment;
2. Have significant or uncontrolled systemic disease;
3. Have significant or uncontrolled cardiovascular disease;
4. Have had other diagnosed malignant diseases that required treatment within the past 3 years besides NSCLC;
5. Currently have or had a history of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonia that requires steroid therapy;
6. Have known hypersensitivity to the similar drugs and excipients of PLB1004;
7. Pregnant or lactating women;
8. Have used other experimental drugs within 2 weeks prior to the first dose of PLB1004;
9. Have any condition or illness that could affect the compliance with the protocol.
China Axial Length Study

The primary objective of this multi-center, observational study is to establish the reference ranges of axial length in Chinese children and adolescents.

30,000 children aged 3-18 years were examined with cycloplegia to collect their ocular parameters and were all followed up for three years with annual visits.


Eligibility Criteria:
Inclusion Criteria:

* Aged 3 to 18 years
* Have been lived in the research areas for at least one year, and will not move to other places in the following two years
* Parents or guardians sign an informed consent form, and children over 6 years old need oral consent to participate

Exclusion Criteria:

* Mental diseases, unable to cooperate to complete the eye assessment
* Ophthalmic diseases, inability to cooperate to complete the inspection
Preoperative Diagnostic Tests for Pulmonary Risk Assessment in COPD

This prospective study intends to investigate the incidence of postoperative pulmonary complications (PPC) or in-hospital mortality in patients with COPD or at risk for COPD undergoing high-risk noncardiac major surgery and to identify relevant risk factors. This study aims to quantify and compare the diagnostic performance of preoperative functional tests, exercise capacity, clinical assessment tests and predictive scoring systems to predict PPC or in-hospital mortality in these patients.

COPD is associated with high perioperative morbidity and mortality and PPC frequently occur in these patients. However, concepts for preoperative pulmonary risk assessment and the predictive value of routine preoperative exercise capacity, clinical assessment and pulmonary function tests are still poorly characterized.

Objectives:

* To determine the incidence of the composite end point of PPC or all cause in-hospital mortality in patients with confirmed COPD (spirometry) and patients with clinical risk factors in whom spirometry disproved COPD.
* To determine the predictive value of exercise capacity, clinical assessment tests, pulmonary function tests and predictive scoring systems to predict the composite end point in these patients.
* To identify relevant risk factors and predictors associated with the composite end point.

Methodology:

Prospective single-centre observational study

All patients receive a structured preoperative pulmonary risk assessment with:

1. standardized clinical questionnaire
2. COPD Assessment Test (CAT™)
3. exercise capacity (symptom-limited stair climbing)
4. spirometry
5. capillary blood gas Analysis

Postoperative follow-up is planned between the 2nd and 5th day after extubation.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* High-risk noncardiac major surgery with an anticipated operation time ≥ 120 minutes and/or planned postoperative intensive care unit admission
* Typical clinical signs for COPD (dyspnea, chronic cough, chronic sputum production, exposure to risk factors)
* Confirmed COPD (medical history) or clinical risk factors for COPD
* Positive COPD Assessment Test (CAT™)

Exclusion Criteria:

* \< 18 Years
* Pregnancy
* Lack of cooperation
* Inability to provide functional tests like spirometry or stairclimbing
A Dose Finding Study of VN-0200

This study will assess the immunogenicity, safety and tolerability of VN-0200 after intramuscular injections in Japanese healthy elderly subjects.


Eligibility Criteria:
Inclusion Criteria:

* Japanese healthy elderly aged \>=60 and =\<80 years (at the time of informed consent).
* Subjects who can follow the compliance requirements during clinical trials, undergo medical examinations and tests specified by the protocol, and report symptoms, etc.

Exclusion Criteria:

* Serious cardiovascular, respiratory, hepatic, renal, gastrointestinal, or neuropsychiatric disorders.
* Serious acute illness.
* Has been diagnosed with congenital or acquired immunodeficiency.
* Previous vaccination with an RSV vaccine (including the investigational drugs).
* Having a history of anaphylaxis or severe allergies due to medicines, or vaccination.
* Administration of gamma globulins, systemic immunosuppressants (including drugs for the treatment of autoimmune diseases), hematopoietics (excluding iron and vitamins), and corticosteroids (excluding topical preparations, inhalants, and small-dose short-term oral administration\*) or planned administration of them in the period starting 28 days prior to informed consent and ending 28 days after the second vaccination. \* \<14 days, 20 mg/day on a prednisolone basis.
* Planned or actual administration of other vaccine in the period starting 14 days prior to informed consent and ending 14 days after the second vaccination.
A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric Patients With Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)

This study will primarily evaluate the pharmacokinetics of satralizumab in pediatric patients aged 2-11 years with anti-aquaporin-4 (AQP4) antibody seropositive neuromyelitis optica spectrum disorder (NMOSD). Efficacy, safety, tolerability, and pharmacodynamics will be evaluated in a descriptive manner, given the small number of patients who will be enrolled in this study.


Eligibility Criteria:
Inclusion Criteria:

* Age at screening 2-11 years, inclusive
* Body weight at screening \>=10 kg
* For female patients of childbearing potential (postmenarchal): agreement to either remain completely abstinent (refrain from heterosexual intercourse) or to use a reliable means of contraception
* Diagnosed as having NMOSD with AQP4 antibody seropositive status as defined by the Wingerchuk 2015 criteria Clinical evidence of at least one documented attack (including first attack) in the last year prior to screening
* Neurological stability for \>=30 days prior to both screening and baseline
* Expanded Disability Status Scale (EDSS) 0 to 6.5
* For patients receiving a baseline immunosuppressant treatment and planning to continue on these therapies, treatment must be at stable dose for 4 weeks prior to baseline

Exclusion Criteria:

* Pregnancy or lactation
* Evidence of other demyelinating disease mimicking NMOSD
* Active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection at baseline
* Evidence of chronic active hepatitis B or C
* Evidence of untreated latent or active tuberculosis (TB)
* Receipt of a live or live-attenuated vaccine within 6 weeks prior to baseline
* History of severe allergic reaction to a biologic agent
Study to Evaluate Safety, Tolerability, and Efficacy of GS-0976 in Adults With Nonalcoholic Steatohepatitis

The primary objective of this study is to evaluate the safety and tolerability of firsocostat in adults with nonalcoholic steatohepatitis (NASH).


Eligibility Criteria:
Key Inclusion Criteria:

* Meets all of the following conditions:

  * A clinical diagnosis of nonalcoholic fatty liver disease (NAFLD)
  * Screening magnetic resonance imaging - proton density fat fraction (MRI-PDFF) with ≥ 8% steatosis
  * Screening magnetic resonance elastography (MRE) with liver stiffness ≥ 2.5 kPa

    * OR
  * A historical liver biopsy consistent with NASH and non-cirrhotic fibrosis
* Platelet count ≥ 100,000/mm\^3
* Creatinine Clearance (CLcr ) as calculated by the Cockcroft-Gault equation ≥ 60 ml/min

Key Exclusion Criteria:

* Pregnant or lactating females
* Alanine aminotransferase (ALT) \> 5 x upper limit of the normal range (ULN)
* Other causes of liver disease including autoimmune, viral, and alcoholic liver disease
* Cirrhosis of the liver

  * Prior history of decompensated liver disease, including ascites, hepatic encephalopathy or variceal bleeding
* Body mass index (BMI) \< 18 kg/m\^2
* International normalized ratio (INR) \> 1.2 unless on anticoagulant therapy
* Total bilirubin \> 1 x ULN, except with diagnosis of Gilbert's syndrome

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.