cyrilzakka/clinical-trials huggingface dataset:
To Compare the Response Rate of Noradrenaline vs. Terlipressin in Hepatorenal Syndrome in Patients With Acute on Chronic Liver Failure

Continous infusion of nor adrenaline + albumin Continous infusion of terlipressin + albumin Response will assessed at every 48 hour (i) Complete response: Regression of acute kidney injury stage with reduction of S. Cr within 0.3 mg/dl of baseline (ii) Partial response: Regression of acute kidney injury stage with reduction of S. Cr to ≥0.3 mg/dl above baseline (iii) No response: No regression of acute kidney injury

Treatment will be extended until reversal of HRS (decrease in creatinine below 1.5 mg/dL) or for a maximum of 7 days after rescue treatment will be followed.

If intolerant to terlipressin, excluded from study and rescue treatment will be given in form of noradrenaline or octreotide and midodrine.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with acute on chronic liver failure presenting with hepatorenal syndrome
2. Patients consented for the study protocol by signing the informed consent.

Exclusion Criteria:

1. Age less than 18 years
2. Decompensated cirrhotics
3. Evidence of chronic kidney disease
4. Patients undergoing renal replacement therapy (hemo-dialysis/renal transplantation).
5. Post liver transplantation patients.
6. History of coronary artery disease, ischaemic cardiomyopathy, ventricular arrhythmia, or peripheral vascular disease.
7. Patients with obstructive uropathy.
8. Patient who withdrew or non complaint to the study protocol.
Study of Diagnostic Biomarkers of Acute Acoustic Trauma

Every year, more than two thousand acute acoustic trauma occur in France, equally between the military and the civilian environment.

Currently, acute acoustic trauma is a pathology with no specific validated treatment, and it is the cause of many handicapping situations. Improving the future of patients requires a better understanding of the neurophysiological mechanisms of noise-induced hearing impairment. They are multiple and pure tone audiometry, the only reference examination, does not allow to differentiate them. Moreover, in the aftermath of acute acoustic trauma, pure tone audiometry tends to improve spontaneously, but this recovery is misleading, as a number of studies in animals have shown that irreversible lesions remain.

The hypothesis of this study is that it is possible to identify new entities, specific to the type of cochlear lesions, in order to clarify the diagnosis of acute acoustic trauma. These entities will be identified by the evaluation of noise-induced hearing impairment via a combination of molecular (proteomic and genomic), physiological and behavioral data. These diagnostic details may then be used to improve prevention or therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 40
* Healthy individuals: without hearing pathology
* Patients: acute acoustic trauma diagnosis within 72h

Exclusion Criteria:

* History of hearing pathology
* History of severe head injury
* Ototoxic drug therapy
* Abnormal otoscopy and/or tympanometry
Bipolar RFA of Painful Extra-spinal Bone Metastases

To evaluate the worst pain of cancer patients with painful extra-spinal bone metastases 1 month after bipolar radiofrequency ablation (RFA) performed with the Osteocool system.


Eligibility Criteria:
Inclusion Criteria:

* 1) Multi-metastatic cancer patients with at least one painful lytic bone metastasis
* 2) Target lesion should correspond to a specific radiologic finding
* 3) At least a moderate pain produce by target lesion (4 on a scale of 0 to 10 over the prior 24 hours with or without pain killers intake) assessed during selection evaluation
* 4) Patients 18 years old
* 5) Able to give written consent
* 6) Life expectancy 1 months
* 7) Patient affiliated to the National Health Insurance system

Exclusion Criteria:

1. Radiation therapy on the target tumor terminated \< 3 weeks before treatment
2. Any contra-indication for the procedure as stated by the radiologist in terms of tumor size, proximity to neural/vascular structures making the procedure at unacceptable risk
3. Any contra-indication for the procedure as stated by the radiologist related to patient's condition (e.g. cardiac pacemakers) making the procedure at unacceptable risk
4. Impaired haemostasis
5. Concurrent participation in other experimental studies that could affect endpoints of this study
6. Contraindication to any form of sedation/anaesthesia
7. Signs of local/systemic infection identified before procedure, in accordance with standard care
8. Sclerotic metastases
9. Adults under guardianship
10. Patients under judicial protection
11. Pregnant or breastfeeding woman
Pilot-trial of Emotion-focused Cognitive Behavior Therapy for Patients With Schizophrenia

The present study is a pilot single-blind randomized controlled therapy study. Its aim is to assess the efficacy of an emotion-focussed form of Cognitive behavior Therapy that focusses on emotional processes that are involved in the formation and maintenance of delusions such as emotional stability, emotion regulation and self-esteem.

Cognitive Behavior Therapy for psychosis (CBTp) is an effective treatment for patients with psychosis. Several meta-analyses showed an effect of CBTp in addition to antipsychotic treatment of small to medium effect size with regard to positive symptoms, general psychopathology and depression. Nevertheless, present research suggests that are especially emotional processes are closely related to positive symptoms and delusions, such as negative emotions, low self-esteem, depression and anxiety, whereas present interventions of CBTp focus often especially on cognitive interventions in order to change delusions as well as more cognitive risk factors for delusions such as reasoning biases and a dysfunctional causal attribution style.

Thus, the aim of the present single-blind randomized-controlled pilot therapy study was to assess the efficacy of a new form of emotion-focussed Cognitive behavior therapy for psychosis with regard to change in positive symptoms and delusions in comparison to standard treatment.

The main hypotheses are:

- Efficacy of CBT-E: patients with schizophrenia who receive CBT-E show a more pronounced reduction of delusions (primary outcome), as well as a more pronounced reduction of positive symptoms, depression and general psychopathology, a stronger improvement in general and social functioning and will receive lower doses of antipsychotic medication (secondary outcomes) at post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia, schizoaffective disorder, delusional disorder or brief psychotic disorder
* Positive and Negative Syndrome Scale score in item P1 (delusions) of at least two
* fluent in German language
* agree to participate
* estimated general intelligence of at least 70 (assessed with the German Wortschatztest (MWT-B)
* no present suicidality

Exclusion Criteria:

* acute suicidality
* comorbid diagnosis of borderline personality disorder and/or substance use disorder in the last six month
* intake of Benzodiazepines
Utility of Some Novel Biomarkers of Patients With Chronic Heart Failure

Clinical and Economic study of some new biomarkers in chronic heart failure.

The study aimed at evaluation of the clinical and economic value of some new biomarkers in chronic heart failure.

Eligibility Criteria:
Inclusion Criteria:

* NYHA-Class II-IV

Exclusion Criteria:

* Liver or renal dysfunction. --DM
Consequences of Female Genital Mutilation on Married Women.

To assess psychiatric, social and sexual consequences of female genital mutilation on married women.

World Health Organization (WHO) defined female genital mutilation (FGM) as ''all procedures that involve partial or total removal of the external female genitalia, or other injury to the female genital organs for non-medical reasons.

Many countries throughout the globe perform it: Western, Eastern, and North-Eastern Africa, particularly Egypt and Ethiopia, and in parts of Asia and the Middle East (nearly half of its cases are in Egypt and Ethiopia).

Moreover, the prevalence of girls and women with FGM/C is also rising in Western countries due to migration flows.

The adverse physical consequences of female genital mutilation/cutting (FGM/C) have been thoroughly investigated and documented. Yet, we know little about the adverse mental health consequences of the practice.

Also, few systematic reviews have addressed the impact of the practice on psycho-social well-being, and there is limited understanding of what these consequences might consist.

Throughout Egypt, many studies have been conducted to determine the pattern and prevalence of FGM, but those studied the risks of FGM and its effect on women's sexual life are scare.

Eligibility Criteria:
Inclusion Criteria:

* Married females aged 18-50 years.

Exclusion Criteria:

* Women who have any chronic disease as diabetes or hypertension.
* Women who have any physical or mental handicap.
* Women who have any psychiatric disorder prior to marriage.
* Women who refuse participation in the study.
Intraosseous Administration of Mesenchymal Stromal Cells for Patients With Graft Failure After Allo-HSCT

Multipotent mesenchymal stromal cells (MSCs) participate in the formation of bone marrow niches for hematopoietic stem cells. Donor MSCs can serve as a source of recovery for niches in patients with graft failure (GF) after allogeneic bone marrow (BM) transplantation. Since only few MSCs reach the BM after intravenous injection, MSCs were implanted into the iliac spine. Preliminary results suggest that MSCs participate in the restoration of niches for donor hematopoietic cells or have an immunomodulatory effect, preventing repeated rejection of the graft. Perhaps intraosseous implantation of MSCs contributes to the success of the second transplantation of hematopoietic stem cells and patient survival.


Eligibility Criteria:
Inclusion Criteria:

* All patients with primary graft failure after allo-HSCT
* Available MSC for this patient

Exclusion Criteria:

* N/A
Fast Brain MRI in Children With Suspected Brain Tumor

This study aims to assess the diagnostic performance of a new fast MRI sequence named Neuromix compared to routine clinical MRI for brain tumor in pediatric patients

The study aims to assess the diagnostic performance of fast MR sequence for the radiological evaluation of brain tumor in comparison to routine clinical MRI (or reference standard) in a pediatric population.

The primary outcome is the depiction and characterization of normal brain, brain tumor pathology and incidental findings.

Sensitivity, specificity, AUC and intra-/ interreader agreement for the diagnostic performance of Neuromix compared to cMRI will be obtained. Correlation of results between methods will be calculated.

Secondary outcomes will also include the assessment of diagnostic image quality and image artifacts.

The study population will consist of subjects aged 0-18 with a suspected or diagnosed brain tumor referred for routine MRI examination of the brain.

Study subjects will be investigated during the same day at 3T MR with Neuromix sequence in addition to the routine MRI examination.

Volume measurements will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Age 0-18 years.
* Pediatric subjects with diagnosed or suspected brain tumor
* Referral routine MRI study.

Exclusion Criteria:

* MRI planned without sedation
* Aborted MR exam
* Unstable patient
Pivotal Response Treatment (PRT) Telemedicine

The purpose of this study is to evaluate the application of a modified version of PRT designed specifically as a parent-training model via telemedicine, with the goal of increasing access to empirically validated care. The project will feature an 18-week trial of parent training PRT via telemedicine in 12 cognitively able 3- to 6-year-old children with ASD. Intervention will focus on enhancing the following developmental skills: expressive and receptive language, play, and social interaction. Outcome measures will address changes in the aforementioned domains during structured observation and standardized assessment.

The purpose of this study is to evaluate the application of a modified version of PRT designed specifically as a parent-training model via telemedicine, with the goal of increasing access to empirically validated care. The project will feature an 18-week trial of parent training PRT via telemedicine in 12 cognitively able 3- to 6-year-old children with ASD. Intervention will focus on enhancing the following developmental skills: expressive and receptive language, play, and social interaction. Outcome measures will address changes in the aforementioned domains during structured observation and standardized assessment.

Eligibility Criteria:
Inclusion Criteria:

* Fits age requirement: age 3-6 years
* Have been diagnosed previously with ASD and meet criteria for ASD when characterized by research team.
* be in good medical health
* be cooperative with testing
* english is a language spoken in the family
* full scale IQ \> 70

Exclusion Criteria:

* significant hearing loss or other severe sensory impairment
* a fragile health status
* a history of significant head trauma or serious brain or psychiatric illness
Erector Spinae Catheter Versus Paravertebral Catheter for Postoperative Analgesia in Cancer Patients Post Mastectomies

All patients admitted in National Cancer institute, Cairo University for breast surgeries will be investigated for inclusion criteria in the current study. And will be enrolled if fulfilled the criteria into 2 groups

.70 patients will be included in this prospective randomized study. The patients will be allocated into two groups: the ESPB group (group E, n = 35) , and the paravertebral group (group P, n =35)

* All patients will do Ultrasound-guided ESPB for group E and PVB for group P before receiving general anesthesia
* Postoperatively Patients in both groups will receive intravenous morphine 3 mg as rescue analgesic

* 70patients will be included in this prospective randomized study. The patients will be allocated into two groups: the ESPB group (group E, n = 35) , and the paravertebral group (group P, n =35)
* All patients will do Ultrasound-guided ESPB for group E and PVB for group P before receiving GA
* Postoperatively Patients in both groups will receive intravenous morphine 3 mg as rescue analgesic.
* Random numbers were generated using a computer-generated randomization code and were sealed in an opaque envelope. Randomization was conducted by a person who was not involved in the study.
* An independent observer who was blind to the group assignment checked the intraoperative and postoperative data.
* VAS pain score immediately postoperative and at 2,4,6, 8,12,18,24,36 ,48hrs.postoperative.

Eligibility Criteria:
Inclusion Criteria:

.Physical status ASA II.

. Patients (age 20-70yrs) scheduled for breast surgeries for breast cancer under general anesthesia

Exclusion Criteria:

.History of psychological disorders.

* Known sensitivity or contraindication to local anesthetics.
* Localized infection at the site of block.
* patients with coagulopathy or an (INR ≥ 2)
Growth Hormone Use in Cystic Fibrosis - a Multicenter Study

Cystic Fibrosis (CF) is the most common lethal genetic disorder in America. Previous studies by our group and others have shown that human recombinant growth hormone (GH) improves height velocity, weight velocity, lean body mass (LBM) and pulmonary function. These positive results have prompted us to ask further questions regarding GH use in CF including: a) Do patients with better baseline body weight and pulmonary function derive more benefit from treatment than those with worse weight and pulmonary function?, b) Does GH use improve the patient's quality of life?, c) Once GH is discontinued, are the positive effects sustained? We hypothesize that GH treatment in CF patients will improve their clinical status and their quality of life. We further hypothesize that these effects will be present regardless of baseline body weight or pulmonary function, and that positive outcome will be sustained for at least one year after GH treatment is discontinued. To test our hypothesis, we will recruit 40 prepubertal children from five CF centers across the United States (8 per center). Patients will be randomly assigned to receive treatment with GH (0.3mg/kg/wk) during either the first or the second year. All subjects will be seen every three months. We will evaluate the following parameters every three months: 1) height, height velocity and Z-score, 2) body weight and weight velocity. Every six months we will measure: 1) lean body mass utilizing DEXA, 2) pulmonary function, including measurement of respiratory muscle strength (peak inspiratory and peak expiratory pressure), 3) quality of life (QOL), quantitated from QOL forms specific for CF ("The Cystic Fibrosis Questionnaire"). After one year of study, subjects will "cross-over" to the other treatment arm. This 24 month study will allow us to statistically compare outcome measures in 20 treated and 20 nontreated subjects from multiple centers, and will allow us to assess sustained effect in the 20 subjects who receive GH during the first year, by comparing their results to results obtained during the year post treatment.


Eligibility Criteria:
Inclusion Criteria:

* CF patients ages 5-12 who are less than the 25th percentile for age and sex normal values for height and/or weight
Development of Prognostic Models for Response and Toxicity to CAR-T Cell Therapy in Patients with Relapsed/refractory Non Hodgkin's Lymphoma.

Observational, single-center, tissue-based cohort study involving both retrospective and prospective enrollment of patients undergoing CAR-T cell therapy and up to 1 year of prospective follow-up necessary to detect the outcomes required by the study

This is a pharmacological observational study, with collection of biological material, single-centre, no-profit, involving both retrospective and prospective enrolment of patients undergoing CAR-T cell therapy and up to 1 year of prospective follow-up necessary to detect the outcomes required by the study.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients with relapsed/refractory non-Hodgkin lymphoma, candidates to receive CAR-T cell therapy according to clinical indication
* Acquisition of informed consent for participation in the study
* Acquisition of consent to the processing of personal data.

Exclusion Criteria:

none
Biobehavioral Effects of Topiramate on Cannabis-Related Outcomes in Adolescents

Cannabis use is a significant public health concern that disproportionately affect youth. Although promising psychosocial interventions are being developed, most youth do not benefit from these interventions alone. Given the clinical demand for effective treatments, the National Institute on Drug Abuse (NIDA) identified the critical need for data on the tolerability and potential efficacy of medications in adolescents. The purpose of this two-year study is to test if and how topiramate, a medication under intense study for treating several drugs of abuse, reduces cannabis use among teenagers. To this end, the investigators will randomize 56 nontreatment-seeking regular cannabis users (15 or 20 years old) to receive topiramate or placebo for 6 weeks. Youth will monitor their cannabis use for the 6-week period using handheld electronic diaries and complete assessments of reactivity to cannabis-related cues.


Eligibility Criteria:
Inclusion Criteria:

* 15 to 20 years old (inclusive)
* Non-treatment seeking for cannabis abuse or dependence
* Able to read English, understand their rights as provided by the informed consent process, and be willing to sign an informed consent form to participant in the study
* If younger than 18 years old, informed consent from a parent or legal guardian is required
* Used cannabis at least 2 days per week during the past 30 days

Exclusion Criteria:

* Treatment seeking or a recent history of treatment for cannabis abuse or dependence
* Endorses a current commitment to stop using cannabis
* Clinically significant physical abnormalities as indicated by physical exam, hematological assessment, bilirubin concentration or urinalysis
* History of renal impairment, renal stones, seizures, or unstable hypertension
* Underweight (i.e., less than the 5th percentile) or overweight (equal to or greater than the 95th percentile), as determined by the Body Mass Index
* Positive urine toxicology screen for narcotics, amphetamines, or sedative hypnotics or self-reported drug use, other than cannabis, alcohol or nicotine, in the past 30 days
* Pregnant, nursing, or refusal to use reliable barrier method of birth control (e.g., condom), if female
* Took a psychotropic medication in the past 30 days
* Taking medications with a potential effect on cannabis use or a carbonic anhydrase inhibitor
* Suicidal
* A current DSM-IV-TR Axis I diagnosis other than attention- deficit/hyperactivity disorder or a disruptive behavior disorder
* A current substance use disorder other than a cannabis, alcohol, and nicotine use disorders
* Significant alcohol withdrawal symptoms
* Known sensitivity to topiramate
Anterior Vs Posterior Procedures for Cervical Spondylotic Myelopathy: Prospective Randomized Clinical Trial

There is no difference in surgical outcomes for patients suffering from cervical spondylotic myelopathy treated with anterior decompression and fusion or posterior cervical laminoplasty.

Cervical spondylotic myelopathy (CSM) is a syndrome consisting of symptoms and signs of cervical spinal cord compression caused by chronic degenerative changes of the cervical spine. CSM is the most serious and disabling condition of cervical spondylosis. Natural history studies showed that most of the CSM patients have a progressive deterioration course and no spontaneous regression occurs. It is suggested that the patients with moderate to severe CSM should be operated as early as possible before neurological deficits are too pronounced.

Although there are many options available for the surgical treatment of cervical spondylotic myelopathy, the choice of surgical approach for CSM is still a controversial issue. Most of the surgeons select the surgical approach based on the number of levels involved and the alignment of the spine. Anterior procedure is generally recommended for patients with compression of less than 3 levels or in patients with kyphotic alignment, while posterior decompression is suggested for three or more levels of compression. Retrospective clinical study however has shown that both anterior and posterior surgeries could produce comparable results. There is no scientific data based on randomized, prospective clinical studies comparing the various surgical alternatives. The existing information does not clearly favor any one single approach or operative option. Since anterior and posterior surgeries carries different risks, it is important to identify the most appropriate surgical procedure that is supported by evidence rather than just by surgeons preference.

The objective of this study is to compare the long-term clinical outcome of anterior approach versus posterior approach in the treatment of cervical myelopathy caused by degenerative disease of the cervical spine.

Eligibility Criteria:
Inclusion Criteria:

* Patients with transverse lesion type of cervical myelopathy caused by cervical spondylosis requiring surgery.
* Involved levels limited to 1, 2 and 3 continuous levels

Exclusion Criteria:

* Radiculomyelopathy
* Cervical kyphosis
* Cervical myelopathy caused by high energy trauma
* Female \> 70 years old or patients with severe osteoporosis
* High anaesthetic risk
* Cervical myelopathy other than transverse type
* Cervical myelopathy caused by ossification of posterior longitudinal ligament or inter-vertebral disc herniation.