cyrilzakka/clinical-trials huggingface dataset:
Preoperative Transarterial Chemoembolization for Resectable HCC With Portal Venous Invasion

Whether preoperative transarterial chemoembolization can prolong survival for the resectable hepatocellular carcinoma remains controversial, particularly in patients with portal vein tumor thrombi. This study designs to systematically identify and summarize the effect of preoperative TACE for resectable HCC with portal venous invasion.

With various improvements in interventional radiology, since the 2005 practice guidelines issued by the American Association for the Study of Liver Diseases , transcatheter arterial chemoembolization has become one of the available locoregional therapies for HCC. Transcatheter arterial chemoembolization, which generally performed in intermediate-stage HCC patients, involves injection of an embolizing agent into the hepatic artery to deprive the tumor of its major nutrient source via embolization of the nutrient artery, resulting in ischemic necrosis of the tumor. To prevent intrahepatic recurrence due to portal vein invasion of the HCC tumor, therapeutic strategies such as preoperative TACE, and postoperative adjuvant chemotherapy have been tried. According to the latest and the most powerful evidence, however, preoperative TACE is not routinely recommended for patients undergoing hepatectomy to treat resectable HCC , and TACE may delay surgical treatment or decrease the resection volume of the liver, or it also may create a missed opportunity for surgical treatment.

Rather than subject all these patients to such an invasive procedure and put them at risk for missing opportunity for surgical treatment, it may be better to select optimal candidates to receive surgical resection. Recent studies have even shown favorable long-term survival outcomes of HR in well-selected cases of HCC with PVTT. About whether preoperative transarterial chemoembolization is available for the resectable hepatocellular carcinoma with portal vein tumor thrombi, so far, has hardly been reported.

Eligibility Criteria:
Inclusion Criteria:

* a) age between 18 and 75 years,
* b) HCC with no previous treatment,
* c) the presence of major PVTT or less on imaging,
* d) Eastern Co-operative Group performance status 030 ,
* e) resectable disease

Exclusion Criteria:

* a) Child-Pugh class B or C liver cirrhosis, or evidence of hepatic decompensation including ascites, esophageal or gastric variceal bleeding or hepatic encephalopathy, or ICGR-15 \>15%,
* b) an American Society of Anesthesiologists (ASA) score ≥ 3,
* c) the presence of distant metastasis or other malignant diseases
Group Cognitive Behavioral Therapy (CBT) Intervention for Women With Mild to Moderate Depression

The purpose of this study is to develop a structured CBT group intervention for women with depression of mild or moderate severity and to pilot a randomized controlled trial to compare this intervention with usual care in socially deprived areas in Bristol, incorporating qualitative methods to assess acceptability.


Eligibility Criteria:
Inclusion Criteria:

* mild to moderate depression
* antidepressant use is also OK

Exclusion Criteria:

* able to speak english
* abusing drugs or alcohol
* using secondary mental health services
Meta-analysis of Stannous Fluoride and the Effects on Gingival Health

The aim of this 18 study analysis was to compare the effect of bioavailable stannous fluoride (SnF2) dentifrices when used up to 3 months on gingivitis relative to a positive or negative control dentifrice.


Eligibility Criteria:
Subjects were excluded from this study for the following reasons;

* pregnancy,
* rampant caries,
* severe periodontitis,
* at discretionary of the Principal Investigator.
Safety, Pharmacokinetics and Pharmacodynamics of Elbasvir (MK-8742) in Hepatitis C Infected Males (MK-8742-002)

The purpose of this study is to assess the safety, pharmacokinetics (PK) and pharmacodynamics of elbasvir (MK-8742) in Hepatitis C Virus (HCV)-infected participants. There will be 3 parts to this study; Part I will enroll only genotype (GT) 1 HCV-infected participants, Part II will enroll GT3 HCV-infected participants, and Part III will enroll only GT1a HCV-infected participants. All parts may run concurrently, or Parts II and III may be staggered.

Hypothesis (Part I): At a once-daily dose that is sufficiently safe and well tolerated in HCV-infected participants, elbasvir administered for 5 consecutive days has superior antiviral activity in GT1 HCV-infected participants compared to placebo, as measured by change from baseline in plasma HCV ribonucleic acid (RNA; log 10 copies/mL) at Day 5, 24-hour postdose timepoint. (a true mean viral RNA reduction of at least 3 log10 is anticipated).

Hypothesis (Part II): At a dose that is sufficiently safe in GT3 HCV-infected participants, the mean maximum reduction in HCV viral load is greater following multiple dose oral administration of elbasvir as compared to placebo.

Hypothesis (Part III): At a once-daily dose that is sufficiently safe and well tolerated in HCV-infected participants, elbasvir administered for 5 consecutive days has superior antiviral activity in GT1a HCV-infected participants compared to placebo, as measured by change from baseline in plasma HCV RNA (log 10 copies/mL) at Day 5, 24-hour postdose timepoint. (a true mean viral RNA reduction of at least 3 log10 is anticipated).


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) of 18 to ≤ 37 kg/m\^2
* Clinical diagnosis of chronic HCV infection defined by positive serology for HCV for at least 6 months and detectable HCV RNA in peripheral blood ≥105 IU/mL at screening
* Participant must be infected with HCV GT1a, GT1b, or GT 3

Exclusion Criteria:

* Co-infection with GT1 and GT3
* Estimated creatinine clearance of ≤70 mL/min based on the Cockcroft-Gault equation
* History of stroke, chronic seizures, or major neurological disorder
* History of clinically significant endocrine, gastrointestinal (excepting HCV infection), cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases
* History of neoplastic disease
* Positive Hepatitis B surface antigen at the pre-study (screening) visit
* Has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks prior to the prestudy (screening) visit.
* Previous treatments (s) with nonstructural protein 5A (NS5A) inhibitors
* \<4 weeks since administration of any experimental protease inhibitor
* Previous exposure to interferon-alpha and/or ribavirin within 3 month prior to the first dose of elbasvir in the study
* Clinical or laboratory evidence of advanced or decompensated liver disease
Mini-CHOP and Rituximab in Patients Aged Over 80 Years

The purpose of the study is to evaluate efficacy and safety of R-miniCHOP for elderly patients with diffuse large B-Cell lymphoma (DLBC) Lymphoma aged over 80 years by measuring the overall survival.


Eligibility Criteria:
Inclusion Criteria:

* Patient with histologically proven CD20+ diffuse large B-cell lymphoma (WHO classification). DLBCL with some small cell infiltration in bone marrow or lymph node may be included.
* Aged over 80 years.
* Ann Arbor stage I bulky, II, III or IV
* Age-adjusted International Prognostic Index equal to 0, 1, 2 and 3.
* Patient non previously treated.
* ECOG performance status ≤ 2.
* With a minimum life expectancy of 3 months.
* Negative HIV, HBV and HCV serologies test ≤ 4 weeks (except after vaccination).
* Having previously signed a written informed consent

Exclusion Criteria:

* Any other histological type of lymphoma.
* Any history of treated or non-treated indolent lymphoma.
* Central nervous system or meningeal involvement by lymphoma.
* Contra-indication to any drug contained in the chemotherapy regimens.
* Any serious active disease (according to the investigator's decision).
* Poor renal function (creatinin level\>150µmol/l), poor hepatic function (total bilirubin level\>30mmol/l, transaminases\>2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
* Poor bone marrow reserve as defined by neutrophils \<1.5 G/l or platelets \<100 G/l, unless related to bone marrow infiltration.
* Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
* Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
* Adult patient under tutelage.
Association Between Functional Impairment and Parenting Stress Among Children Diagnosed with Diplegic Cerebral Palsy

1. To find out the relation between the severity of ADL limitation in diplegic CP children and the level of parents' stress.
2. To detect the correlation between the PS level to the different domains of ADL limitation.
3. To determine the substantial factors that underlying the parents' stress of those diplegic CP children.

The health and well-being of children are intimately related to their parents' physical, emotional and social health in addition to child-rearing practices. The way parents of CP children deal with their stress may adversely affect their parenting ability, which in turn leads to difficulties for the child, which may lead to more parenting stress. The extent to which parents of CP children adjust and the resources to meet the needs of their children is of primary concern to professionals working in children's healthcare.

To support parents, it is important to determine the level of independence of diplegic CP children in their daily lives. This is necessary to identify predictors of their stress, which may be a mentally debilitating factor in their lives. In return, it may support us as physiotherapists to make more informed decisions about treatment planning, as well as facilitate conversations with parents around identifying sources of stress and developing healthy coping strategies that lead to a better quality of life for their children. Finally, this will have a direct positive impact on the children's abilities

Eligibility Criteria:
Inclusion Criteria:

* Diplegic CP children.
* Their age ranges from 18 months to five years old.
* All levels of GMFCS will be included.
* Both sexes will be included.
* All children were medically and clinically stable.
* Parents must be able to write and read.

Exclusion Criteria:

* Diplegic CP children, who might have one or more of the following:

  * History of chronic cardiac or chest disease.
  * Any behavioral disorders.
  * Current hospitalization for urgent medical reasons.
  * Significant visual or auditory impairment.
  * Previous history of Botox injection within last six months.
Optimized Volumetry in Radiology: Interest in Pediatric Brain MRI in the Exploration of Focal Epilepsy

Multicentre cross-sectional study with prospective recruitment comparing the detection rate of lesions on brain MRI without and with quantitative volumetry and T1 relaxometry information during the management of children with suspected focal epilepsy.

Focal epilepsies are a very heterogeneous group comprising epilepsies of structural, genetic, metabolic, immune and infectious etiologies. In daily practice, epilepsy is considered as structural if lesions are visible on brain MRI in a location consistent with electro-clinical data. In the absence of visible lesion and clinico-biological arguments for a genetic, metabolic, immune or infectious cause, these epilepsies can be divided into two groups: self-limited focal epilepsies (formerly called idiopathic or functional), such as benign epilepsy with centrotemporal spikes (SLECTS) and secondly epilepsies of unknown causes. This classification underlines the idea that a lesion might be responsible for the epileptic disease but could be invisible due to the lack of sensitivity of our current diagnostic methods, especially in imaging.

The prevalence of patients with non lesional epilepsy defined by MRI is significantly higher in children (31%) than in adults (21%). Epileptic patients with normal conventional MRI have a lower chance of having surgery than those with lesions demonstrated by presurgical MRI and, if so, less chance of becoming seizure-free. It can be challenging to depict brain volume abnormalities in the pediatric population on MRI. The major challenge is therefore to raise sensitivity of brain imaging analysis. Voxel-based morphometric MRI post-processing in MRI-negative epilepsies can be a practical and valuable tool to aid subtle MRI abnormalities detection and confirm visually identified questionable abnormalities in patients with focal epilepsy.

In this study, we prospectively included children with suspected focal epilepsy having a brain MRI using a MP2RAGE sequence and a post-processing morphometric analysis program (MAP) allowing us to obtain automatically both brain volumetry and T1 relaxometry. The MAP has been validated with reference ranges in healthy children. Our hypothesis was that the quantitative information will improve the sensitivity of brain MRI in children with suspected focal epilepsy. The objectives were to compare the rate of detection of a focal cerebral lesion on the brain MRI carried out during the exploration of suspected focal epilepsy without then with the quantitative volumetry and T1 relaxometry obtained in the inclusion center and then by double anonymized review.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 1-18 years
* Referred or followed by a pediatrician for epilepsy with focal onset
* Requiring brain MRI as part of the work-up

Exclusion Criteria:

* Opposition of the child and/or parent to data processing
* MRI not interpretable
* Clinical and epileptic data not available or not specifying focus
Postdural Puncture Headache Relief With Aminophylline and SPGB

The purpose of the study is to compare Sphenopalatine ganglion block (SPGB) and aminophylline in the efficacy and safety management of PDPH.

Postdural puncture headache (PDPH) is a severe and debilitating complication after regional anesthesia in the obstetric population; The gold standard treatment for PDPH is epidural blood patch, which is an invasive and risky procedure.

The trans-nasal sphenopalatine ganglion (SPG) block and intravenous aminophylline are promising options for PDPH. So the investigators designed this randomized, double-blind study to compare Sphenopalatine ganglion block (SPGB) and aminophylline in the efficacy and safety management of PDPH.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 40 years old female.
* ASA I -II according to the American society of anesthesiologists.
* Spinal anesthesia with 22G Quincke needle for cesarean section.
* PDPH was defined according to the international classification of headache disorders, 3rd edition criteria (ICHD-3) as:

  * Headache occurring within 5 days of a lumbar puncture.
  * Orthostatic headache that significantly worsens soon after sitting upright or standing and/or improves after lying horizontally usually accompanied by neck pain, tinnitus, changes in hearing, photophobia, and/or nausea.
  * Exclusion of other causes such as hypertension, preeclampsia, tension headache, migraine, etc.

Exclusion Criteria:

* A history of headaches that could interfere with the PDPH diagnosis,
* A history of central nervous system diseases, including intracranial hemorrhage, seizures, intracranial hypertension, or hydrocephalus
* A history of cardiovascular diseases, including coronary heart disease, arrhythmias, or hypertension.
* A history of allergy to or any contraindication for using Aminophylline.
* Coagulopathy.
* Nasal septal deviation, polyp, or nasal bleeding.
* General anesthesia after failed spinal anesthesia.
Metacognitive Therapy Versus Cognitive Behavioral Therapy for Mixed Anxiety Disorders: A Randomized Controlled Trial.

Comorbidity is normal in clinical practice. Metacognitive Therapy (MCT) is a transdiagnostic model and could therefore be well suited when it comes to treating patients with high rates of comorbidity. So far, no studies have examined MCT in comparison with the best documented and evidence based treatment, cognitive behavioral treatment(CBT), in a randomized controlled trial consisting of mixed anxiety disorder sample with high degree of comorbidity.

The main aim of this study is to 1) Evaluate the effectiveness of metacognitive therapy in a sample of mixed anxiety disorders as compared to a group receiving existing evidence-based single diagnosis CBT- treatment protocols 2) Investigate patterns and mechanisms of change in the two treatments.


Eligibility Criteria:
Inclusion Criteria:

* DSM IV diagnoses of SAD, PD/A or PTSD (CSR\>4)
* Withdraw of all psychotropic medications before treatment

Exclusion Criteria:

* Psychosis
* Not willing to accept randomization
* Comorbid conditions are in immediate need of treatment
The Efficacy of Citicoline in Eyedrops (OMK1) in Reducing the Progression of Glaucoma

Double-blind study (OMK1 vs. Placebo) A total of 90 patients, 30 per center, will be the study sample. The study will include patients with Primary Open angle Glaucoma (glaucoma or pseudoexfoliation) with a loss of visual field with MD between -2 dB and -15 decibel.

Patients will be randomized into 2 treatment groups, both treated with hypotonic ocular drug therapy: one part of the patients will be treated with the OMK1 Medical Device containing topical citicoline for 3 years; the remaining part will receive a placebo.

All patients will be followed with quarterly visits which will check, in addition to the intraocular pressure (IOP), the structure of the optic nerve and visual function (standard visual field).

The primary objective is to evaluate a reduction of the perimetric progression in the group that receives the topical citicoline compared to the group treated with placebo. The reduction of the progression will be evaluated with Spectral Domain Optic coherence tomography and with standard perimetry (SAP).

The secondary objective is to assess the tolerability and safety of OMK1 eye drops.


Eligibility Criteria:
Inclusion Criteria:

* Patients with POAG and pseudoexfoliation glaucoma in one or both eyes. In the latter case, only one eye (chosen at random) will be used for the analysis.
* Patients with -2 \< MD \< -15 dB, progression of MD at least -0,5 dB/y for 2 years.
* Patients with tonometric compensation, i.e., IOP not above 18 mmHg. Tonometric compensation can be achieved with any type of hypotonic medical therapy and must be maintained during the 3 years of the study. If at any check-up the average of at least 3 measurements of IOP at different times is higher than 18 mmHg, the patient will be offered a new hypotonic treatment (including surgery) to control the progression of the disease. If compensation cannot be achieved (e.g., the patient refuses the proposed therapy or, in spite of this does not achieve satisfactory IOP values), the patient will be excluded from the study.
* Patients over the age of 18 years

Exclusion Criteria:

* Patients with contraindications to citicoline
* Patients with IOP higher than 18 mmHg
* Patients with other forms of glaucoma
* Patients treated with other neuroprotective therapies
* Women who are pregnant and/or breastfeeding
* Pediatric or adolescent patients aged under 18 years
Postural Alignment Exercise Mobile App for Cervical and Thoracic Spine Regions

Postural alignment in the cervical and thoracic regions is affected by various risks such as smartphone use in particular young adults. The small screen of smartphones causes ergonomic risk for posture and musculoskeletal system. Previous studies found that neck, shoulder, and upper back pain associated with the overuse of smartphones. Neck pain often arises from unideal postures. Participants should be informed about these risks and encouraged to exercise to be protective. Digital health apps' use is rising by the day and health apps offer opportunities for both healthcare professionals and users.

Therefore, this study aimed to develop an app including preventive exercise interventions to keep postural alignment in cervical and thoracic spine regions employing an iterative, user-centred design and to test the usability of the app and evaluate its effectiveness with a pilot randomized controlled trial


Eligibility Criteria:
Inclusion Criteria:

* to be a university student aged 18-25, to be a smartphone user for more than 3 years with more than three hours daily use.

Exclusion Criteria:

* if they had any chronic health problems (rheumatic, orthopedic, neurological, cardiopulmonary, vestibular system), any trauma in the neck/upper back/upper limb region in the last six months, had a congenital deformity, had received another treatment or having surgery in last one year.
Carbapenems De-escalation as Antimicrobial Stewardship

Early de-escalation of carbapenems can reduce unnecessary use of carbaepenems compared with late de-escalation without compromised clinical outcomes

A cluster randomized control trial was conducted among patients receiving care at the medicine units of the Maharaj Nakorn Chiang Mai Hospital.

Patients were randomly assigned into 2 groups. The standard group followed the hospital policy in which carbapenems were evaluated by ID specialist at 72 hours of admission (late de-escalation). De-escalation may occurred earlier depends upon the decision of the primary care team. The intervention group is de-escalation carbapenems early within 24 hours or no later than 72 hours of prescription by ID specialist (early de-escalation).

Clinical outcomes included rate of de-escalation within the first 24 hour, the mortality rate, and other clinical outcomes.

Eligibility Criteria:
Inclusion criteria

* All adult patients aged ≥ 15 years old
* received carbapenems (meropenem and imipenem/cilastatin) empirically within 24-72 hours for the first time during admission
* able to sign informed consent

Exclusion criteria

* They were in the intensive care units, or had neutropenia (absolute neutrophil count \< 1,000 cell/mm3)
Modulation of Visual-Spatial Learning in Healthy Older Adults by tDCS

The aim of this study is to investigate whether a combination of intensive training of visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation (tDCS) leads to an improvement of learning and memory in healthy older adults and to examine the underlying neuronal mechanism.


Eligibility Criteria:
Inclusion Criteria (old healthy controls):

* right handedness
* unobtrusive neuropsychological screening
* age: 50-90 years

Exclusion Criteria:

* severe internal or psychiatric disease
* epilepsy
* other severe neurological diseases, e.g. previous major stroke or brain tumor
* DMS-IV manifest dementia
* contraindication for MRT (claustrophobia, metallic implants, tattoos)