cyrilzakka/clinical-trials huggingface dataset:
Accuro and the Use of Real Time Ultra Sound With Acoustic Puncture Assisted Device to Confirm Epidural Space End Point

Aim of the work:

To compare the use of the Accuro ultrasound and a real time ultrasound guided epidural combined with the acoustic puncture assisted device to perform the epidural anesthesia Secondary aim is to compare the incidence of complications associated with each technique.

Patient's selection:

This study will be performed on 100 pregnant patients scheduled for normal vaginal delivery under epidural analgesia.

The sample size was calculated by taking success rate of conventional LOR to be 98% in the patients; assuming 80% power, with 95% confidence interval (CI) of two techniques and 30% margin of error.

The study protocol will be reviewed and approved by the Ethics Committee of the Alexandria Main University Hospitals.

A written consent will be obtained from all the patients participating in this study.

Complete history will be taken from all the patients and will be subjected to thorough examination and routine laboratory investigations. Patients will be randomly divided into two equal groups using a computer-generated program.

Group I consists of 50 patients scheduled for epidural catheter insertion using the Accuro ultrasound imaging assisted technique.

Group II consists of 50 patients scheduled for epidural catheter insertion using the real time ultrasound guided technique combined with the use of the acoustic puncture assist device (APAD) technique.


Eligibility Criteria:
Inclusion Criteria:

* pregnant patients scheduled for normal vaginal delivery under epidural analgesia.

Exclusion Criteria:

* • Any contraindication for epidural analgesia

  * High risk pregnancy or precious baby.
  * Patients not willing for participation.
Anti-T-Lymphocyte Globulin (ATG) in Renal Transplantation of Kidneys With a Non-Heart-Beating (NHB) Donor

One of the greatest problems in renal transplantation is the shortage of donor kidneys. Kidneys of non-heart-beating donors (NHB) are a possible solution, but transplantation is accompanied with a high percentage of acute renal failure, caused by ischemia-reperfusion injury. The increased ischemia-reperfusion injury results in an increased immune activation, which can lead to more injury of the kidney and additional acute rejections. The hypothesis of this trial is that ischemia-reperfusion injury can be diminished by ATG. ATG could have additional favourable effects. To investigate this half of the patients is treated with additional ATG to the standard immunosuppressive treatment. Calcineurin inhibitors are not diminished during the first days after transplantation to investigate whether ATG has special effects on ischemia-reperfusion injury.


Eligibility Criteria:
Inclusion Criteria:

* Non-heart-beating-donors (Maastricht III/IV)
* Female patients of childbearing age agree to maintain effective birth control practice during the study.

Exclusion Criteria:

* Pregnant or lactating women at the time of randomization.
* Patients and donors are ABO incompatible.
* Women having had \>3 pregnancies (including abortions if no consistent data on PRA or anti-donor antibodies are available).
* Patients with hypersensibility to rabbit proteins, previous treatment with rabbit IgG, or known intolerance to any component of basal immunosuppression.
* Patients with leukocytes \<3,000/mm3 and/or platelets \<50,000/mm3 before initiation of transplant.
* Patients, who are HIV positive.
* Patients subjected to previous transplants or candidates for multiple transplants (e.g. SKP).
* Patients, who are unlikely to comply with the visit schedule in the protocol and patients who cannot communicate reliably with the investigator.
* Patients with pulmonary oedema or with other signs of overhydration.
Musculoskeletal Pain in Patients With Covid-19 Who Have Hospital Care

Worldwide, the COVID-19 pandemic continues to grow. Although COVID-19 mainly affects the lungs and internal organs, musculoskeletal injury from this disease was reported with the presentation of marked elevation in creatine kinase and lactate dehydrogenase levels. Patients with post-acute COVID-19 are considered patients with a post-intensive syndrome (PICS) that results in loss of functional independence.

In the physical and rehabilitation medical field, various modalities with therapeutic exercise can be used to manage pain by a physical therapist and psychiatrist.

Pain management is particularly important during the COVID-19 pandemic because of the reduced accessibility to hospitals and medical resources.

The COVID-19 survivors with pain symptoms will participated. In this phase, a face-to-face interview will be conducted to collecting all outcomes about pain.

Eligibility Criteria:
Inclusion Criteria:

* Recovered from COVID-19 infection.
* COVID-19 survivors after hospitalization.
* Musculoskeletal pain.

Exclusion Criteria:

* Participants will be excluded also if they score greater than 6 points on the Beck Depression Inventory (BDI) or more than 30 points in the State Trait Anxiety Inventory (STAI), dementia and not Italian speaking due to the high level of language skills required for questionnaires and quantitative sensory testing.
* Psychiatric or neurological disorders
Effect of Supplementation of Fish Oil on Non-alcoholic Fatty Liver Disease in Children

The aim of this study is to evaluate efficacy of fish oil (EPA/DHA) in children with non-alcoholic fatty liver disease.

76 children or adolescents aged 6-19 with NAFLD will be included in the study. Diagnosis of NAFLD is set by increased alanine transaminase and features of liver steatosis on ultrasound. Patients will be randomized to receive either fish oil (EPA/DHA, 400-1200mg) or placebo (sunflower oil) for 6 months. All children will be advised to reduce weight (dietetic intervention + increased physical activity). Laboratory tests, liver ultrasound, anthropometric analysis will be performed at the start, after 3 months and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* age 6-19
* overweight or obesity
* ALT activity over 130% of upper limit norm
* hyperechogenicity of the liver on ultrasound

Exclusion Criteria:

* HCV, HBV infection
* cholestasis
* chronic/acute liver failure
* alpha-1-antitrypsin deficiency
* Wilson disease
* type 2 diabetes mellitus
* beta-oxidation defects
* alcohol consumption
* history of parenteral nutrition
* use of drugs
High Flow Nasal Cannula and Hypercapnia

In the present investigation, in 50 COPD with persistent hypercapnia after an acute exacerbation, the investigators want to assess the acceptability of HFNC and its effectiveness in further reducing the level of PaCO2, and to eventually verify the hypothesis, based on previous physiological studies, that the response to HFNC is dependent on the level of baseline hypercapnia and eventually on the presence of overlap syndrome. This latter parameters to eventually calculate the sample size and the target population to perform future definitive randomized long term trials vs NIV.

Fifthy COPD patients inpatients recovering from an acute exacerbation of their disease and persisting hypercapnia, despite having reached a stabilization in pH (i.e. pH\>7,35 and PaCO2\>45 mmHg on 3 consecutive measurements) will be enrolled in the study after having signed a written informed consent OSA/COPD overlap syndrome was not considered and exclusion criteria and is defined as the presence of 15 or more obstructive respiratory events per hour of sleep, when a previous full night polysomnography (PSG) was available or from a positive Epworth questionnaire and a Body Mass Index\>25 Cardiac decompensation, restrictive thoracic disorders, renal insufficiency, cancer, and neurological disease were considered exclusion criteria.

On day the patients will undergo a preliminary trial with HFNC to set the optimal flow, using the AIRVO2 (Fisher \& Paykel Healthcare, Auckland, New Zealand). To this aim the patients will be asked to breathe keeping their mouth closed, as much as they could, at different levels of flow, starting from 20 L/min up to 40 if tolerated for a minimum of 15 minutes for each trial. At the end of this test the maximum level tolerated will be chosen as the flow to be set for the experimental procedure. Temperature will be set according to the patient's tolerance starting from 34C, up to 37C, while FiO2 will be kept constant to maintain an SaO2 between 92 and 94%.

From 9 am of day 2 to 9 am of day 5 (72 hours period), the patients will undergo HFNC for at least 8 hours/day and during the nightime. The nurse on shift will be in charge of supervising the adherence to this schedule and to report any violation of the protocol on a dedicated sheet. Every morning at 10 am (1 hour after HFNC suspension) Arterial Blood Gases (ABGs), effective hours of HFT and tolerance to the treatment as reported by the patient, using a dedicated scale where: )1. Very bad 2. Bad 3. Moderate 4. Good 5.very good) will be recorded

Eligibility Criteria:
Inclusion Criteria:

* inpatients recovering from an acute exacerbation of their disease
* persisting hypercapnia, despite having reached a stabilization in pH (i.e. pH\>7,35 and PaCO2\>45 mmHg on 3 consecutive measurements)

Exclusion Criteria:

* Cardiac decompensation,
* restrictive thoracic disorders,
* renal insufficiency,
* cancer,
* neurological disease
A Randomized Controlled Trial of In-Home Tele-Behavioral Health Care Utilizing Behavioral Activation for Depression

This study will evaluate the effectiveness of a web-based behavioral activation(BA) treatment for depression by comparing it to in-person BA treatment in Soldiers and Veterans with Major and Minor Depressive Disorder. We will test the hypothesis that 8 sessions of in-home BA delivered via a webcam will be as safe and effective in reducing symptoms of hopelessness and depression as in-person BA treatment for depression.


Eligibility Criteria:
Inclusion Criteria:

* Current Major Depressive or Minor Depressive Disorder
* High-speed internet/network access at home (384kbs minimum)
* Informed consent
* Fluent in the English language

Exclusion Criteria:

* Currently undergoing psychotherapy for depression
* less than 18 or greater than 65 year of age
* Active psychotic symptoms/disorders as determined by the SCID for DSM-IV
* Dysthymic Disorder
* Current suicidal ideation with intent or recent (within six months) history of a suicide attempt
* History of Organic Mental Disorder
* Current substance dependence as determined by the SCID (lifetime substance dependence or substance abuse will not be excluded)
* History of violence or poor impulse control causing potential risk to staff or others
* Significant ongoing stressors that require urgent crisis intervention
* Having a living arrangement that will not permit the use of a private space to participate in the study
Evaluation of Nilotinib In Patients With Advanced Gastrointestinal Stromal Tumor (GIST)

This study will assess time-to-disease progression in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib ≥600 mg.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of GIST that is unresectable and/or metastatic
* Radiological confirmation of disease progression or intolerance to imatinib therapy at a any dose
* At least one measurable site of disease on CT scan at Visit-2
* WHO Performance Status of 0, 1 or 2 at Visit-2
* Patients must have normal organ, electrolyte, and marrow function at Visit-1 and Visit-2

Exclusion Criteria:

* Prior treatment with nilotinib or any other tyrosine kinase inhibitors except imatinib.
* Treatment with any cytotoxic and/or investigational cytotoxic drug ≤ 4 weeks
* Prior or concomitant malignancies other than GIST
* Impaired cardiac function at Visit-1 or 2
* Patients with severe and/or uncontrolled concurrent medical disease
* Use of therapeutic coumarin derivatives
* Use of any medications that prolong the QT interval
* Use of CYP3A4 inhibitors
* Patients who have undergone major surgery ≤ 2 weeks prior to Visit-1 or who have not recovered from side effects of such surgery
* Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation \< 2 weeks prior to Visit-1 or who have not recovered from side effects of such therapy

Other protocol-defined inclusion/exclusion criteria may apply
Comminuted Proximal Humeral Fractures. A Randomised Study of Surgical Versus Conservative Treatment

1. Do a standardized surgical treatment of unstable displaced proximal humerus fracture in patients aged over 60 compared to a standardized conservative treatment gain a better functional outcome after one year?
2. Do surgical treatment gain more QALY than conservative treatment after one year?


Eligibility Criteria:
Inclusion Criteria:

* proximal humerus fracture of AO group B2 or C2 (displaced fracture of extra-articular or articular, bifocal type) admitted in hospital

Exclusion Criteria:

* aged less than 60 year
* patients of non-Scandinavian ethnicity
* previous history of injury or illness of the injured or contralateral shoulder
* injury of other part of the humerus or the contralateral upper extremity,
* alcohol- or drug abuse
* dementia or neurological diseases
* severe cardiovascular disease that would contraindicate surgery
Pre-FRONTal Brain STability, Key for Action Against Disability in AGing

Cognitive and mobility impairments are critical contributors to dementia and disability in older adults, and can be caused by neurodegenerative and neurovascular changes at the pre-frontal (PF) brain areas. In a previous technological project funded by ISCiii, the investigators adapted a non-invasive, point-of-care optical methods (fNRIS/fDCS technology) to study PF metabolism and blood flow activation during cognitive and motor tasks, in older adults with and without cognitive impairment. These methods are sensitive to change after physical exercise (PE) and after selectively and safely stimulating PF areas with electrical transcranial direct current stimulation (tCS). PE and tCS have shown benefits for cognition and mobility in the elderly, but their prolonged effect on PF hemodynamic activation has not been studied. Understanding the specific action of these interventions on the brain, and their clinical cognitive and motor impact, is key to fine-tune appropriate treatment strategies.

The FRONT STAGE project aims to compare, through a 3 arms single-blind randomized clinical trial, the impact of a 10 weeks, 1 hour/week program of PE (arm 1) Vs PE+tCS (arm 2) and Vs a control group (arm 3, healthy aging sessions and control of cardiovascular risk factors). The PE program is already implemented in primary care, as part of another previous project of the investigators' research group. Outcomes will include the optical measurement of PF metabolism and blood flow and clinical measures of cognitive and physical function. Front STAGE project will recruit 93 older adults with cognitive impairment and slow gait, but without dementia or disability in the activities of daily living (N=31 per arm). They will receive a comprehensive geriatric assessment at baseline, together with the optical, cognitive and physical measures, and will be follow-up at 3 and 6 months. Weekly physical activity through accelerometry will be controlled in analyses.

FRONT STAGE project centered on aging and the prevention of dementia and disability, will provide, translationally, more evidence to support and enlarge the clinical application of these interventions, and will contribute to foster further research in this field.


Eligibility Criteria:
Inclusion Criteria:

1. older adults (65 years or older)
2. with Motoric Cognitive Risk Syndrome
3. characterized by impaired cognition (which in our case will be confirmed with a Spanish version of the Montreal cognitive Assessment (MOCA), score between 26 and 21)
4. mobility impairment (measured as slow gait speed\<0.8 m/s)
5. without diagnosed clinical neurological or psychiatric diseases
6. with a preserved functional status for the activities of daily living
7. who can walk without help from third parties

Exclusion Criteria:

1. a diagnosis of dementia
2. advanced/terminal disease (life expectancy\<1 year)
3. contraindications to exercise and tCS
4. unwilling to give informed consent
Comparative Study Between Platelet Rich Plasma and Steroid Injection in Trigger Finger Treatment

The goal of this clinical trial is to learn if platelet rich plasma works to treat early stage trigger finger in adults. It will also learn about the safety platelet rich plasma. The main questions it aims to answer are:

Does platelet rich plasma lower the pain associated with trigger finger of participants? Does it improve the hand grip strength and Q DASH score of participants? Researchers will compare platelet rich plasma to Depo-Medrol steroid (a known standard of care for early stage trigger finger) to see if platelet rich plasma works to treat early trigger finger.

Participants will:

Take platelet rich plasma or a depo-medrol steroid intralesional injection at recruitment into the intervention Visit the clinic once every 4 weeks for checkups and parameter measurements. Investigator will will keep a record of participants progress in symptom remission


Eligibility Criteria:
Inclusion Criteria:

* Patients who are 18year and above with mild or moderate trigger finger, who are willing to have intra-lesional administration of blood product.

No previous treatment for the affected finger.

Exclusion Criteria:

* Previous steroid injection
* Previous Surgery to that finger
* Thrombocytopenic patients
* Hand and finger contracture
* Rheumatoid arthritis of the finger
Statistical Analysis Plan for the SANO-trial: Neoadjuvant Chemoradiotherapy Followed by Surgery Versus Active Surveillance for Oesophageal Cancer

An active surveillance approach is proposed after completion of neoadjuvant chemoradiotherapy (nCRT) for carcinoma of the oesophagus. In this SANO (i.e. Surgery As Needed for Oesophageal cancer) approach, surgical resection is offered only to patients in whom a locoregional regrowth is highly suspected or proven, without distant dissemination. Such an organ-preserving strategy can have great advantages, but is only justified if long-term survival is non-inferior to that of the current standard trimodality approach comprising neoadjuvant chemoradiotherapy followed by standard surgery. The aim of this study is to assess the (cost-)effectiveness (including non-financial costs and survival) of active surveillance for patients with squamous cell- or adenocarcinoma of the oesophagus or oesophago-gastric junction.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent or are planned to undergo neoadjuvant chemoradiotherapy according to CROSS and are planned to undergo potentially curative surgical resection for histologically proven oesophageal or junctional squamous cell carcinoma or adenocarcinoma are eligible. Whenever pathology is inconclusive but a multidisciplinary expert group concludes oesophageal carcinoma because of radiologically or endosonographically highly suspected lesions, patients are eligible for the study.
* Age ≥18;
* Written, voluntary, informed consent.

Exclusion Criteria:

* Language difficulty, dementia or altered mental status prohibiting the understanding and giving of informed consent and to complete quality of life questionnaires;
* Non-FDG-avid tumour at baseline PET-CT scan;
* Initial treatment with endoscopic resection.
Romiplostim (AMG 531) Versus Medical Standard of Care for Immune (Idiopathic) Thrombocytopenic Purpura

This is a phase 3b, multi-center, randomized, Standard of Care (SOC)-controlled, open-label, 52-week treatment study to compare romiplostim to medical SOC for Idiopathic Thrombocytopenia Purpura (ITP), with a 6-month Safety Follow-up. Patients randomized to romiplostim must complete the taper or discontinuation of medical SOC for ITP as soon as medically feasible after the initiation of romiplostim. After the completion or discontinuation of the study treatment period, any participant who does not transfer in to another romiplostim study will complete a 6-month Safety Follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥ 18 years of age
* Subject has a diagnosis of Idiopathic Thrombocytopenia Purpura (ITP) according to the American Society of Hematology (ASH) guidelines
* If subject is \> 60 years of age, subject has a written bone marrow biopsy report confirming the diagnosis of ITP
* Subject has received at least 1 prior therapy for ITP
* Subject has a platelet count \< 50,000 or their platelet count falls to \< 50,000 during or after a clinically-indicated taper or discontinuation of current ITP therapy
* Before any study-specific procedure, the appropriate written informed consent must be obtained

Exclusion Criteria:

* Subject has had a splenectomy for any reason
* Subject has an active malignancy
* Subject has a history of cancer, other than basal cell carcinoma or cervical carcinoma in situ, with treatment or active disease within 5 years
* Subject has a known history of bone marrow stem cell disorder
* Subject has participated in any study evaluating polyethylene glycol-conjugated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF), recombinant human thrombopoietin (rHuTPO), AMG 531, or a thrombopoietic protein
* Subject is receiving other investigational agents or procedures
* Subject is currently enrolled in, or has completed within the last 30 days, another investigational device or drug study
* Subject is pregnant or breast feeding
* Subject is not using adequate contraceptive precautions
* Subject has known sensitivity to any recombinant E. coli-derived product
* Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and does not have a legally acceptable representative
* Subject has any kind of disorder that compromises the ability of the subject to comply with study procedures
Safety and Efficacy Study of Omalizumab to Treat Allergic Asthma

The primary purpose is to evaluate the safety and efficacy of recombinant humanized anti-IgE monoclonal antibody injection in patients with allergic asthma.

Omalizumab will be given as add-on treatment to budesonide inhaled powder in patients with moderate or severe allergic asthma(IgE\>=60IU/ml), who demonstrate inadequate asthma symptom control. Response to Omalizumab will be assessed by the overall improvement in control of asthma.

Omalizumab is a recombinant humanized monoclonal antibody that selectively binds to human immunoglobulin E(IgE). The antibody has a molecular weight of approximately 150 kilodaltons and produced by Chinese Hamster Ovary cell.

Omalizumab inhibits the binding of IgE to the high-affinity IgE receptor on the surface of mast cells and basophils. Reduction in surface-bound IgE on cells limits the degree of release of mediators of the allergic response.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 15\~65 years
* Written informed consent provided
* Total serum IgE \>=60IU/ml
* Duration of allergic asthma \>= 1 year according to GINA(2008)
* Poor response to moderate to high dose inhaled corticosteroid (400ug/day\~800ug/day) \>= 4 weeks
* Agreed to be not pregnant, contraception during study and later 6 months.

Exclusion Criteria:

Patients who met the below criteria were excluded:

* Be regular smokers(\>10 cigarettes per day and for at least 2 years)
* Patients who are currently pregnant or nursing or intend to become pregnant over the course of the study or later 6 months
* COPD, according to the guideline of Chinese society of respiratory diseases
* An active lung disease other than allergic asthma
* Patients with significant underlying medical conditions
* Allergic to immunoglobin or any formulation ingredient of the product
* Patients with diabetes or uncontrolled hypertension(Systolic blood pressure\>160mmHg or Diastolic blood pressure\>95mmHg)
* HIV positivity or cancer patient
* Prior exposure to Xolair