cyrilzakka/clinical-trials huggingface dataset:
Development and Feasibility Testing of an Advanced Practice Physiotherapy Role in Chronic Pain Management

The current study is intended to evaluate the feasibility of conducting a future trial to evaluate the effects of implementing an advanced practice physiotherapist (APP) role within a chronic pain clinic setting.

This line of research ultimately seeks to assess the impact of integrating an APP as the first point of contact within interprofessional chronic pain clinics on patient health outcomes, care provided to patients, chronic pain clinic flow, and cost-utility in comparison to usual physician or nurse practitioner-led care.

The primary objectives of the feasibility study are:

1. To determine the feasibility of implementing the trial methods by evaluating participant recruitment rates, retention, and assessment completion at each of four follow-up time-points over a 12-month period.
2. To determine the feasibility of implementing the new APP model of care by monitoring the care provided and treatment fidelity.
3. To explore the perspectives of participants and health care providers related to the acceptability of the APP role; barriers, facilitators, and strategies for refining implementation; and perceived impact on clinic processes and outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Chronic musculoskeletal pain (pain \> 3 months in duration) (e.g., neck pain, thoracic pain, limb pain, low back pain) -OR-
* Chronic widespread pain (e.g., fibromyalgia, myofascial syndrome) -AND-
* 18 years of age or older -AND-
* Must be able to read, write, and speak English

Exclusion Criteria (as identified in referral package):

* Primary reason for referral stated as medication change or interventional pain management (e.g., injections, nerve block)
* Primary reason for referral is stated as headache or migraine.
* Reason for referral is chronic pelvic pain
* Referral includes information that patient has an untreated addiction, mental health disorder, or substance use disorder
* Referral indicates cancer-related pain
* Referral indicates medical "red flags" suggestive of non-musculoskeletal etiology of symptoms (e.g., unexplained symptoms, sudden weight loss, urinary retention, saddle anesthesia, evidence of upper motor neuron lesion, or fever)
* Referral states visceral pain or abdominal pain.
Genetics of Alpha Thalassemia in Israeli Ethnic Groups

Alpha thalassemia causes mild anemia and is found in many ethnic groups. Usually it is found in regions where malaria is endemic. We have found that alpha thalassemia is common in Ashkenazim, whose countries of origin are in temperate climates.

We are analyzing the alpha globin genes of individuals of many ethnic groups and will compare to try to define the origin of thalassemia in these individuals of European extraction.

Alpha thalassemia causes mild anemia and is found in many ethnic groups. Usually it is found in regions where malaria is endemic. We have found that alpha thalassemia is common in Ashkenazim, whose countries of origin are in temperate climates.

We are analyzing the alpha globin polymorphisms to determine the haplotypes of individuals of many ethnic groups and will compare to try to define the origin of thalassemia in these individuals of European extraction.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of deletional alpha thalassemia

Exclusion Criteria:

* under age 18
Study of Copeptin as a Diagnostic Marker for Acute Pancreatitis

The purpose of this study is to investigate if there is an association between copeptin level in serum and the severity of pancreatitis and if copeptin can be used as a predictor for organ failure and pancreatic necrosis with or without superinfection.

Acute pancreatitis may range from mild to severe disease with high mortality in case of infected pancreatic necrosis. Due to its rising incidence it remains an important healthcare problem in Europe and US. The assessment of the severity of pancreatitis is crucial for the further management and the prognosis. Several quite complex scores like Ranson or APACHE II scores has been used in the past with reasonable sensitivity for necrosis or superinfection as well as inflammation markers like c-reactive Protein.

Copeptin, the C-terminal part of antidiuretic hormone, is a relatively stable peptide in blood circulation. Several studies investigated Copeptin in the presence of Systemic Inflammatory Response Syndrome (SIRS) or sepsis, myocardial infarction, lower respiratory tract infection and cerebral stroke. Copeptin has shown to be a helpful prognostic marker in these diseases. The aim of this prospective study is to investigate whether Copeptin can be used to assess the severity of pancreatitis.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of acute pancreatitis
* written informed consent
* inpatient treatment

Exclusion Criteria:

* time interval between onset of abdominal symptoms and study inclusion \>96h
* patients unable to consent
Impact of Sarcopenia on Postoperative Outcomes of Patients Undergoing Liver Resection

The investigators will investigate the impact of different biometric parameters (Body mass index, sarcopenia, lean muscle mass, hand-grip strength, gait speed, fat composition) on the postoperative outcomes of patients undergoing liver resections.

Major and minor liver resections will be considered as well as open and minimally invasive techniques.

Benign and malignant indications will be included. Patients characteristics and perioperative variables will be considered for analysis.

Short-term outcomes will be evaluated focusing on 90-days morbidity and mortality and readmission rate.

According to the null hypothesis, no difference in postoperative morbidity between the two groups would be expected. To calculate sample size, a 42% morbidity rate would be expected in sarcopenic patients while a 22% rate would be expected in the non-sarcopenic group. Considering a two-sided α=0.05 and β=0.1, the minimal sample size required to achieve statistical significance was 224 subjects. Considering a 10% drop-out rate of patients undergoing explorative laparoscopy or laparotomy without parenchymal resection a total of 249 patients will be required for completion of the study

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing open or laparoscopic liver resection
2. Patients undergoing major or minor liver resection
3. Patients undergoing liver resection for primary or secondary liver malignancies
4. Patients undergoing liver resections for benign diseases (cysts, adenoma, focal nodular hyperplasia, hemangioma) -

Exclusion Criteria:

1. Patients undergoing extrahepatic resection
2. Patients undergoing cyst fenestration or biopsies without liver resections
3. Patients with extrahepatic metastases
4. Patients undergoing explorative laparoscopy or laparotomy without parenchymal transection -
Auditory Beat Stimulation and Behavioural Variant of Frontotemporal Dementia

The goal of this study is to examine the effects of auditory beat stimulation on anxiety in patients diagnosed with bvFTD. Main aims are:

* to ascertain whether anxiety in bvFTD patients can be modulated using auditory beat stimulation
* to investigate patterns of anxiety and mind wandering in bvFTD patient population

Patients were asked to complete a number of questionnaires relating to well-being and mind wandering, as well as to listen daily to audio files of beat stimulation.

Eligible patients and their caregivers were asked to give informed written consent, if they wished to participate after an initial interview. Once enrolled, they began the study by joining a consultation with their consultant neurologist and the study coordinator. Patients each received a handbook to guide them day by day during the course of the study and an mp3 player containing the auditory beat stimulation files. The handbook also contained copies of the questionnaires the patients were asked to complete at different points during the two week study (mind wandering questionnaire, State-Trait Anxiety Inventory, Beck Depression Inventory, Rogers' Happy/ Sad Face Scale). Over the course of two weeks patients completed the questionnaires and listened daily to an auditory beat stimulation or a control recording for 20 mins at home.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria are the international criteria of a behavioral variant of FTD according to Raskovsky and colleagues (2011), which include:

A. Early disinhibition B. Early apathy or passivity C. Early loss of compassion or empathy D. speech or motor stereotypies E. Hyperorality and altered eating habits F. Neuropsychological profile with executive function deficits with relatively unchanged memory and visuospatial performance G. Disruption of daily living skills H. Matching imaging (cMRI, cCT, PET).

Exclusion Criteria:

* Exclusion criteria include the presence of a non-neurodegenerative psychiatric disease that can better explain the behavioral abnormalities or evidence of biomarkers with clear evidence of Alzheimer's disease or other neurodegenerative process
Integrated Molecular Analysis of Cancer (IMAC)

The purpose of the study is to identify biomarkers and potentially actionable mutations/ activated molecular pathways and evaluate the impact of molecular profiling information on patients with cancer.

The hypothesis of the study are:

* Analysis of tumour samples will allow us to identify novel and/or actionable molecular changes that may drive therapeutic strategies for the management of cancers.
* Molecular profiling will improve the outcome of novel targeted-agent treatment in clinical trials
* Molecular profiling of paired samples (primary/recurrent and primary/metastatic) will provide new insights into mechanisms underlying drug resistance and metastasis in cancers.

Advances in our understanding of cancer biology has led to a rapid expansion of molecularly targeted therapeutics in pre-clinical and clinical development over the last decade. The systematic sequencing of cancer genomes has revealed that individual tumours frequently harbor multiple "driver" somatic mutations that confer growth advantage and positive selection. Importantly, many of the altered proteins resulting from the mutations identified by these studies are in fact actionable, i.e. "druggable", targets. Hence, evaluating drug efficacy in tumours selected by a combination of histopathology and molecular analysis has the potential to result in a greater therapeutic gain. The premises behind personalised cancer medicine include: i) genetic aberrations exist in human malignancies; ii) a subset of these aberrations frequently exist across multiple tumour types and have functional relevance as drivers for oncogenesis and tumour progression; iii) the molecular effects of these genetic aberrations are potentially actionable targets; and iv) there are medicinal compounds that can safely and effectively modulate such targets in patients with these tumours. The key challenge to optimising this personalised approach to cancer therapy is to ensure that patients with tumours harbouring specific molecular/ genetic aberrations are specifically matched to a particular drug or combination of drugs. In this respect, molecular analysis of tumours to identify somatic mutations and/or other genetic aberrations are examples of enrichment strategies to assist in matching patients to drugs or treatments that have gained increasing interest in the oncology community. The ability to characterise the unique genetic features of each patient's tumour will be a critical step to identifying the optimal therapeutic strategy for the individual.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with histological confirmation of cancers who are candidates for systemic therapy, including molecular-targeted therapy/ biomarker-driven clinical trials.
2. Patients must be ≥ 21 years old.
3. All patients must have signed and dated an informed consent form.
4. All patients must have sufficient tumour tissue for molecular profiling

Exclusion Criteria:

Unable to provide informed consent
Evaluation of Ivacaftor in Patients Using Ataluren for Nonsense Mutations

The purpose of this study is to explore the combination of Ataluren and ivacaftor as a treatment for patients with a specific cystic fibrosis mutation

In about 10% of patients with CF, the defect in the gene is known as a stop mutation. This mutation truncates the cystic fibrosis transductive regulator (CFTR) protein production by introducing a premature stop in the messenger RNA (mRNA), this type of mutation is known as a stop mutation. Ataluren is a novel, oral drug that promotes this gene to work effectively and readthrough that premature "stop sign". It is hypothesized that ivacaftor may increase the efficacy of Ataluren by activating a specific protein that may not be functioning properly.

Eligibility Criteria:
Inclusion Criteria:

1. Evidence of signed and dated informed consent/assent document(s) indicating that the subject (and/or his parent/legal guardian) has been informed of all pertinent aspects of the trial.
2. Age ≥19 years
3. Body weight ≥16 kg
4. Diagnosis of cystic fibrosis and documentation of the presence of a nonsense mutations of the CFTR gene, as determined by historical genotyping
5. Ability to perform a valid, reproducible spirometry with demonstration of a forced expiratory volume in 1second (FEV1) ≥30% of predicted for age, gender, and height.
6. If the subject is sexually active, willingness to abstain from sexual intercourse or employ a barrier or medical method of contraception during the study drug administration
7. Willingness and ability to comply with all study procedures and assessments.
8. Currently receiving Ataluren for nonsense mutations through other clinical trial access.

Exclusion Criteria:

1. Any change (initiation, change in type of drug, dose modification, schedule modification, interruption, discontinuation, or re-initiation) in a chronic treatment/prophylaxis regimen for CF or for CF-related conditions within 2 weeks prior to screening.
2. Evidence of pulmonary exacerbation or acute upper or lower respiratory tract infection (including viral illnesses) within 2 weeks prior to screening.
3. Ongoing immunosuppressive therapy (other than corticosteroids up to 10mg/d equivalent of prednisone)
4. Ongoing warfarin, phenytoin, or tolbutamide therapy.
5. History of solid organ or hematological transplantation.
6. A history of positive hepatitis B surface antigen test, hepatitis C antibody test, or human immunodeficiency
7. Major complications of lung disease (including massive hemoptysis, pneumothorax, or pleural effusion) within 4 weeks prior to screening.
8. Pregnancy or breast-feeding.
9. Current smoker or a smoking history of ≥10 pack-years (number of cigarette packs/day × number of years smoked).
10. Prior or ongoing medical condition (eg, renal failure, alcoholism, drug abuse, psychiatric condition), medical history, physical findings, ECG findings, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the subject, makes it unlikely that the course of treatment or follow-up would be completed, or could impair the assessment of study results.

    -
Artificial Intelligence in the Detection of Right Sided Colonic Polyp in Different Operator Experience

Colonoscopy is the gold standard modality for the detection of colonic polyp. However, miss polyp occurs especially in right sided colon. Artificial intelligence (AI) is one of the modality to improve polyp detection but the benefit of AI in operators with different endoscopic experience is still limited. This study aimed to evaluate the efficacy of AI in the detection of right sided colonic polyp in operators with different endoscopic experience by using double insertion of right side colon, back-to-back basis.


Eligibility Criteria:
Inclusion Criteria:

* participants age 40-80 years

Exclusion Criteria:

* History of colonic surgery (except appendectomy)
* Lower gastrointestinal bleeding
* unstable vital sign during endoscopy of pregnancy
* history of inflammatory bowel disease, polyposis syndrome, colon cancer, colonic stricture, abnormal coaglulation, organ failure
Memory During Inhalation Anesthesia Performed With or Without Bispectral Index (BIS) in Patients Undergoing Thyroidectomy

The purpose of this study is 1) to investigate whether the use of BIS as a guide to the administration of inhaled anesthetic (sevoflurane or desflurane) compared with the use of hemodynamic parameters (blood pressure and heart rate) would affect the occurrence of implicit memory and /or dreams recall and 2) to check whether the occurrence of implicit memory and/or dreams recall is related with MAC (Minimal Alveolar Concentration) of inhalational anesthetics and/or preoperative anxiety levels.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70 years
* Class-ASA Physical Status I-II

Exclusion Criteria:

* Psychiatric or neurological disorders and/or hearing disorders
* Obesity (Body Mass Index \> 30)
* Drug addiction, alcoholism
* Patient with difficulty in understanding italian language and/or education level below middle school
The Implementation of the Go Wish Game to Promote Advance Care Planning in Onco- Hematologic Disease

This is a mixed-method, device-free and drug-free multicenter interventional study. The study aims at facilitating end-of-life conversations within the doctor-patient relationship through the use of the Go Wish Game (GWG) and supporting patients, their caregivers and healthcare professionals to complete Advance Care Panning documentation.

The GWG helps people clarify and identify their priorities, should they be affected by a chronic, disabling and potentially non-healing illness. In fact, the GWG consists of a small deck of cards, and on each card is a concrete action or situation that may be important to a person at the end of life.

The "Onco-hema Go wish-ACP" project aims to evaluate the feasibility of a Go Wish Game-based intervention with patients with refractory lymphoma, leukemia or multiple myeloma or advanced solid tumors with prognosis \> 3 months.

In terms of secondary objectives, the study aims to.

* Evaluate and compare the intervention with hematology and oncology patients in terms of: - Other feasibility indicators; Involvement in CCP pathways; Quality of communication; Meaning of life; Impact on hope; through a series of questionnaires administered to patients and caregivers involved in the intervention
* Qualitatively assess the acceptability of the intervention in terms of recruitment and delivery with patients and caregivers through semi-structured interviews and with professionals through Focus Groups (FGs).
* To analyze the clinical records of enrolled patients in terms of: values and preferences; awareness of prognosis; end-of-life choices and shared decision-making on treatment decisions.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years age; diagnosed with refractory lymphomas, or leukemia or multiple myeloma or advanced solid tumors and estimated prognosis \> 3 months;
* able to communicate in Italian and
* to give written consent to the study.

Exclusion Criteria:

* Patients with severe cognitive impairment or serious psychiatric condition;
* refusal to participate to the study
Alteration of Deep Brain Stimulation Parameters for Dystonia

Deep brain stimulation (DBS) involves placing electrodes into the brain. Through these electrodes, artificial electrical signals are chronically delivered into deep brain regions in order to alter abnormal brain activity. The artificial electrical signals are generated by a battery that is inserted under the skin of the chest. DBS is used to treat several disorders of movement, including dystonia. In dystonia, the electrodes are inserted into a brain region called the globus pallidus.

Globus pallidus stimulation can be very effective therapy for dystonia. However not all patients are equally responsive and therapeutic outcomes can be frustratingly variable. The reason for this variability is unclear. Such variability in response may need to be met by tailoring stimulation to individual patients.

Another issue with deep brain stimulation is battery life. Eventually, batteries become depleted and need to be replaced. Such battery replacements require an operation, hospital stay and the risk of introducing infection. The high electrical energy that has been used to treat dystonia means that batteries are typically replaced every year or two.

The artificial electrical signals of deep brain stimulation are delivered with three parameters; frequency (Hertz - Hz), voltage (volts) and pulse width (microseconds). It has recently been reported that lower frequency stimulation, at 60Hz rather than 130Hz, can be used effectively to treat dystonia. Such 60Hz stimulation may be more effective for some patients than others. The lower energy demands of 60Hz stimulation would also greatly improve battery life (potentially doubling battery life).

The aim of this study is to assess if 60Hz stimulation is more effective in ameliorating the dystonia of patients who have responded poorly to 130Hz pallidal stimulation. The current status of the evidence is one of clinical equipoise (uncertainty) and therefore suits a double blinded randomised trial.


Eligibility Criteria:
Inclusion Criteria:

* Primary dystonia (focal cervical or generalised dystonia) who are receiving chronic (\>1 year) bilateral pallidal stimulation but have had poor therapeutic responses (\< 50% improvement in relevant dystonia severity rating scale\*) despite confirmation of accurate electrode position.
* Able to understand study requirements - able to provide consent.

  * Relevant dystonia rating scales: Cervical dystonia - severity subsection of the Toronto Western Hospital spasmodic torticollis rating scale; Generalised dystonia - severity section of the Burke Fahn Marsden rating scale.

Exclusion Criteria:

* None.
Effect of Fish Oil on Adiposity and Atherogenic Factors in Type 2 Diabetic Women

1. whether the intake of n-3 PUFA has additional effects on insulin sensitivity and adiposity (total fat mass and adipocyte morphology and function) in T2D women.
2. n-3 PUFA supplementation might influence inflammatory genes expression in the adipose tissue of T2D patients.

Thus, the present study was designed to evaluate the effects of n-3 PUFAs dietary supplementation on lipid and glucose homeostasis and to address the impact of this treatment on adiposity and adipose tissue gene expression in T2D women.A total of 27 T2D women (BMI 27-35kg/m², age 40-60 y) were randomly allocated to two months of 3 g/day of either fish oil (1.8 g n-3 PUFA) or placebo (paraffin oil), in a double-blind parallel design.

Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetic postmenopausal women
2. glycaemia of 7.87-14.0 mmol/l, HbA1c of 7 to 10.5%
3. plasma triglycerides between 1.72-4.6 mmol/l,
4. aged between 40 -60,
5. BMI: 27-40 kg/m2
6. able to swallow tablets

Exclusion Criteria:

1. patients with abnormal renal, hepatic and thyroid functions as determined by physical examination, blood cell count and standard blood biochemical profile
2. patients with gastrointestinal disorders
3. patients treated with thiazolidinediones or insulin
Use of Laser Speckle to Study Post Occlusive Reactive Hyperhemia in Healthy Subjects

The investigators aim to test the hypothesis that Laser speckle contrast imaging allows for the measurement of cutaneous blood flow following various durations of tourniquet ischemia.

Ischemia and post occlusive reactive hyperemia in the skin is tested in healthy normal subjects for tourniquet ischemias of 1, 2 \& 3 minutes at rest.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Affiliation to the French health system

Exclusion Criteria:

* Any disease or chronic treatment