cyrilzakka/clinical-trials huggingface dataset:
Effects of Dexmedetomidine During Radiofrequency Ablation of Abdominal Tumours

The purpose of he study is to evaluate effects of dexmedetomidine on pain during radiofrequency ablation of liver and kidney tumours.

Although radiofrequency ablation (RF) is accepted as the best therapeutic choice for patients with early stage hepatocellular carcinoma when liver transplantation or surgical resection are not suitable options, it is still performed only in a few hospitals and experience is so far limited (Goldberg \& Ahmed, 2002; Shiina et al., 2005). In addition, RF ablation is emerging as a viable alternative to surgery for inoperable patients with limited hepatic metastatic disease, especially from colorectal cancer. Although radiofrequency ablation has been accepted as a safe and effective treatment for liver and kidney tumours, there are few studies addressing periprocedural pain.

Thus, the optimal anaesthetic procedure is still to be determined. Currently at our institution RF is performed as monitored sedation procedure using remifentanil infusion supplemented with midazolam boluses, when considered necessary. However, when using remifentanil and midazolam combination it is quite difficult to avoid too deep respiratory depression.

Dexmedetomidine is an α2-adrenoreceptor agonist with sedative, analgesic and anxiolytic effects, and it has more selective α2-adrenergic effect than clonidine. Dexmedetomidine has a great deal of potential in this arena given its analgesic and anxiolytic properties while preserving respiratory drive (Bergese SD et al., 2010).

All patients will receive dexmedetomidine 0.4 µg/kg/hr infusion from the start of procedure. The infusion will be continued during the whole RF procedure.

At the same time all patients will receive remifentanil infusion according to TCI (target controlled infusion) protocol. Plasma concentration target will be set from 0.5 ng/ml and, if necessary, will be increased to achieve a comfortable state of patient (Ramsey Sedation Scale: 2-3).

Eligibility Criteria:
Inclusion Criteria:

* liver or/and kidney cancer for which radiofrequency ablation procedure is planned
* signed informed consent form

Exclusion Criteria:

* patient refusal
* pregnancy
* known allergy to dexmedetomidine or remifentanil
* atrioventricular block grade II or III or other significant cardiac conduction disturbance
* stroke
* low blood pressure not responding to treatment
Nitrate and Brain Insulin-Sensitivity

Disturbances in brain insulin-sensitivity are not only observed in abdominal obesity and type 2 diabetes mellitus (T2D), but also during brain aging and in dementia. Inorganic nitrate may improve brain insulin-sensitivity, which can be quantified by measuring the gray-matter cerebral blood flow (CBF) response to intranasally administered insulin, through beneficial effects on brain vascular function. Therefore, we now hypothesize that inorganic nitrate, which can be found in several vegetables such as beetroot, improves brain insulin-sensitivity, as assessed by the gray-matter CBF response to intranasally administered insulin, in abdominally obese men.


Eligibility Criteria:
Inclusion Criteria:

* Men;
* Aged between 18 - 60 years;
* Waist circumference \> 102 cm (abdominally obese);
* Fasting plasma glucose ≤ 7.0 mmol/L;
* Fasting serum total cholesterol ≤ 8.0 mmol/L;
* Systolic blood pressure \< 160 mmHg and diastolic blood pressure \< 100 mmHg;
* Stable body weight (weight gain or loss \< 3 kg in the past three months);
* Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study;
* Willingness not to use antibacterial mouth wash or toothpaste, chewing-gum and tongue-scraping a week before the study;
* No difficult venipuncture as evidenced during the screening visit.

Exclusion Criteria:

* Women;
* Left-handedness;
* Current smoker, or smoking cessation \< 12 months;
* Diabetic patients;
* Familial hypercholesterolemia;
* Abuse of drugs;
* More than 3 alcoholic consumptions per day;
* Use of products or dietary supplements known to interfere with the main outcomes as judged by the principal investigators;
* Use medication to treat blood pressure, lipid or glucose metabolism;
* Pharmacological treatment advised based on the Dutch general practitioners' association (NHG) for cardiovascular risk management;
* Use of an investigational product within another biomedical intervention trial within the previous 1-month;
* Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis;
* Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident;
* Specific contra-indications for MRI imaging, including pacemakers, surgical clips/material in body, metal splinters in eye, claustrophobia, or tattoos in the facial area, such as permanent make-up.
TLK286 in Combination With Doxil in Platinum Refractory or Resistant Ovarian Cancer

This is a dose-ranging, open-label, Phase 1-2a study of TLK286 in combination with Doxil in patients with platinum refractory or resistant ovarian cancer.


Eligibility Criteria:
Inclusion Criteria

* Histologically or cytologically confirmed diagnosis of epithelial cancer of the ovary, fallopian tube cancer or primary peritoneal cancer
* Recurrent epithelial ovarian cancer or persistent disease following primary treatment
* At least one, but no more than four, prior platinum-containing chemotherapy regimens
* At least one prior taxane-containing regimen

Exclusion Criteria

* A history of prior malignancy except for adequately treated carcinoma in situ of the uterine cervix, basal cell or squamous cell skin cancer, or other cancer for which the patient has been disease-free for 2 years
* Known leptomeningeal metastases or carcinomatous meningitis
* Have received prior Doxil or other liposomal doxorubicin
* Having received whole pelvis radiation therapy
Respiratory Weaning Following Cardiac Surgery.

Respiratory weaning failure worsens prognostic of patients following on-pump cardiac surgery. There are increasing evidences that pulmonary, diaphragmatic or cardiologic echographies are useful in order to improve this critical medical status.

Based both on a previous study conducted in the critical care unit of Purpan and on literature we hypothesize that a combined thoracic echography score could be of interest. We make the hypothesis that the use of a score based on thoracic combined echography (ETC = cardiac, pulmonary and diaphragmatic) allows to predict the failure of respiratory weaning in cardiac surgery and allows to improve the characterization of the causes of this failure


Eligibility Criteria:
Inclusion Criteria:

* Adult (\> 18 years old) beneficiating of mechanical ventilation following cardiac surgery
* Weaning test period
* Patient insured under the French social security system

Exclusion Criteria:

* Tracheostomy
* Neurological disorders
* Need for prophylactic non invasive ventilation.
* Global obstructive lung disease with a forced expiratory volume \< 50%.
* Judicial protection
* Patient already included in a trial still running.
* Pregnancy
Natural History and Longitudinal Clinical Assessments in NCL / Batten Disease, the International DEM-CHILD Database

This is an observational study that aims at assessing the natural history of NCL diseases as part of the international DEM-CHILD Database.

1. Patient data are collected from medical records, patient questionnaires and routine follow up clinical examinations with focus on assessing progression in key areas of disease such as motor, language, cognition, seizures, vision, and behavior.
2. A local biorepository of samples from genetically defined NCL patients will be established as well as a virtual biorepository within the DEM-CHILD DB to be able to easily localize international availability of patient samples.

NCLs (Neuronal Ceroid Lipofuscinoses) are a group of rare, inherited, neurodegenerative disorders, also known as Batten disease. Until now, 13 different genes causing different subtypes of disease are known. The genetic mutations cause a symptom complex of progressive loss of acquired skills in the domains of motor function, cognition and visual function, leading to ataxia, movement disorder, dementia, blindness and seizures. In the area of genetic testing, variable clinical phenotypes become more and more prevalent. The disease-mechanisms as well as the exact clinical course of the diseases are currently still not fully understood and documented. Although descriptions of the clinical spectrums exist, the natural history needs to be defined as accurately as possible. These data are urgently needed as clinical control data helping to test the therapeutic efficacy of emerging experimental therapies.

Since samples of genetically defined patients are rare and therefore limited for research, there is an urgent need for researchers to localize and access samples internationally. With the establishment of a local NCL-biorepository and virtual sample localization internationally, scientists worldwide may have a faster way to access needed samples for advancing research.

Any NCL patient with a confirmed molecular diagnosis can join the retrospective and prospective natural history data collection. It is also possible for families with already deceased patients to participate in the retrospective analysis part of the data collection if the genetic mutation is known.

Eligibility Criteria:
Inclusion Criteria:

- Patients with a confirmed molecular diagnosis of a form of NCL Disease

Additional inclusion criteria for Group/Cohort: "CLN2 Disease - ERT (Brineura) Treated":

* Documented diagnosis of TPP1 deficiency
* Previous or current treatment with intracerebroventricular ERT with cerliponase alpha
* Patients that are currently participating in post-marketing studies will be allowed to participate.

Exclusion Criteria:

- Patients with no confirmed molecular diagnosis of a form of NCL Disease
Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support)

The purpose of this study is to evaluate the safety and efficacy of the Low Profile Visualized Intraluminal Support(LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc. when used to facilitate endovascular coiling of wide-necked intracranial aneurysms with coils.


Eligibility Criteria:
Inclusion Criteria:

* Subject age between 18 and 75 years
* Subject with an unruptured or ruptured(\>30days since occurence), wide-necked (neck ≥4mm or dome to neck ratio \<2)intracranial saccular aneurysm (\<20mm maximum diameter in any plane)

Exclusion Criteria:

* Subject with significant extra or intracranial stenosis of the parent artery (\>50%) proximal to the target aneurysm.
* Subject with any condition which in the opinion of the treating physician would place the subject at high risk of embolic stroke
* Subject with contraindications to the use of antiplatelet agents
* Subject who is unable to complete the required follow-up
Mechanisms of Arm Recovery in Stroke Patients With Hand Paralysis

This study examines the effect of non-invasive brain stimulation targeting different brain areas on movement of the affected arm post-stroke. Participants will receive stimulation to each of 3 different brain areas combined with a session of arm exercise.

Small improvements in affected arm movement can be made with intensive physical practice. These improvements could potentially be enhanced by combining non-invasive brain stimulation with practice.

To develop such an intervention, it is necessary to understand which brain areas should be stimulated in which types of patients. It is probably more beneficial to target one side of the brain vs. the other, for example, depending on the characteristics of the stroke.

This study will examine the effect of stimulating one side of the brain vs. the other on the amount of improvement that occurs from physically practicing functional arm movements.

Eligibility Criteria:
Inclusion Criteria:

* More than 6 months post-stroke
* Loss of voluntary finger movement in the affected hand
* Some voluntary movement of affected shoulder and/or elbow

Exclusion Criteria:

* Brainstem or cerebellar stroke
* Severe cognitive or language deficits
* Epilepsy or other seizure disorder
* Central nervous system disease or disorder other than stroke
Functional Capacity in Institutionalized Elders

Getting old is a process of transformation of the body that occurs along the vital cycle in a universal and progressive way causing functional restrictions in the human being. The aim of this work was to identify, analyze and quantify the limitations of the functional capacity of the institutionalized elderly who are not provided with physiotherapic assistance.

A descriptive, qualitative, quantitative and transverse field research was made, based on an evaluation of the activities of daily living (ADL) using the Katz Index, with 62 institutionalized elderly people from Casa do Pobre de Maceió, Alagoas, both genders, average age of 77.03 years old and different levels of functions. Activities related to the self care were emphasized. At first, people were classified as independent, partially dependent and totally dependent. According to the Katz Index score, they were classified regarding their functional dependency, which varies from level 0 (a totally independent person) to level 6 (a totally dependent person in the six evaluated functions).

Eligibility Criteria:
Inclusion Criteria:

* To be elderly and a resident of Casa do Pobre de Maceió

Exclusion Criteria:

* Individuals under the age of 60 years and over 90, or received private care or physical therapy who refused to participate in the evaluation
Brain Imaging and Pain in Irritable Bowel Syndrome

This study examines the mechanisms, including brain imaging of placebo analgesia


Eligibility Criteria:
Inclusion criteria:

* Irritable Bowel Syndrome
* English speaking

Exclusion criteria:

* Chronic pain condition other than Irritable Bowel Syndrome
* Medical condition that would contraindicate use of lidocaine
* Clinical criteria for fibromyalgia
* Presence of systemic disease such as diabetes, thyroid, gastrointestinal or liver disease, collagen vascular disease, malignancy, focal or neurological
* Seropositive HIV
* Pregnancy
Deep Biopsy Via Endoscopic Submucosal Dissection in Upper GI Subepithelial Tumors

Upper gastrointestinal subepithelial tumors are frequently encountered during esophagogastroduodenoscopy. Treatment plans for subepithelial tumors are determined by algorithms based on endoscopic ultrasonography images. However, endoscopic ultrasonography alone may not be able to diagnose and evaluate upper gastrointestinal SETs with sufficient accuracy. Adequate tissue samples are required to increase the diagnostic accuracy of subepithelial tumors.

Deep biopsy is method that normal mucosa was dissected using enodsocpi submucosal dissection technique and multiple endoscopic biopsies were performed.

The investigators will perform deep biopsy in subepithelial tumor.


Eligibility Criteria:
Inclusion Criteria:

* patients with upper GI SETs

Exclusion Criteria:

* none
DEB-TACE Treatment in 367 Liver Cancer Patients

Introduction:The drug-eluting beads transarterial chemoembolization (DEB-TACE) is introduced to better improve efficacy and reduce the systemic toxicity in liver cancer patients on account of its higher intratumoral chemotherapeutic drug concentration and reduced drug infiltration into systemic circulation. This study aimed to investigate the efficacy, safety and prognostic factors of DEB-TACE treatment in Chinese patients with liver cancer.

Hypothesis:DEB-TACE illustrates a better treatment response, progression free survival (PFS), overall survival (OS) and less common adverse events (AEs) in liver cancer patients.

Objective: to investigate the efficacy, safety and prognostic factors of DEB-TACE treatment in Chinese patients with liver cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed as primary HCC, primary ICC or secondary liver cancer confirmed by pathological findings, clinical features or radiographic examinations according to American Association for the Study of the Liver Diseases (AASLD) guidelines;
2. Age above 18 years;
3. About to receive DEB-TACE treatment with CalliSpheres® according to clinical needs and patients' willing.
4. Able to be followed up regularly;
5. Life expectancy above 12 months.

Exclusion Criteria:

1. History of liver transplantation;
2. History of hematological malignances;
3. Severe hepatic failure or renal failure;
4. Contraindication for angiography, embolization procedure or artery puncture;
5. Patients with cognitive impairment, or unable to understand the study consents.
6. Women in gestation or lactation period.
Prediction of Clinical Response and Outcome in Uterine Cervix Cancer

Observational study based on the routine clinical treatment and diagnostic course, to correlate imaging features with outcome objectives. Outcome will evaluated as clinical response to the standard treatment and as recurrence and survival in the follow up. The study hypothesis is that data extracted form FDG-PETCT used in the routine clinical practice can predict outcomes following standard treatment.

This study will prospectively collect patients undergoing to the standard diagnostic and treatment protocol in Maastro Clinic. Any difference in the normal procedure will be adopted. The aim is to extrapolate form the PET images some features of the metabolic tumor activity to associate with different outcomes and tumor behaviours.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed cervix carcinoma (all subtypes)
* Tumor Stages FIGO IB - IVA
* Scheduled for primary curative radiotherapy (either or not combined with chemotherapy or hyperthermia)
* pre treatment FDG PETCT
* The patient is willing and capable to comply with study procedures
* 18 years or older
* Written informed consent to the treatment

Exclusion Criteria:

* Recent (\< 3 months) myocardial infarction
* Uncontrolled infectious disease
* Pregnant or breast feeding and/or not willing to take adequate contraceptive measures during the study
* Previous surgery to the Cervix
* Previous radiation to the Cervix
Strength After Breast Cancer

The goal of this study is to explore whether a group exercise program called Strength After Breast Cancer can be delivered in an outpatient physical therapy clinic to improve physical function among women after treatment for breast cancer.

The main questions this study aims to answer are:

* Can the Strength After Breast Cancer program and the associated outcome battery be successfully delivered in an outpatient physical therapy clinic at Massachusetts General Hospital and do participants find the program practical?
* What are the barriers to and facilitators of delivering the group exercise program in a clinical setting and what changes need to be made to the program to improve sustainability and to facilitate implementation at other clinical sites?

Participants will complete study questionnaires before and after engaging in the group exercise program and they will participate in interviews following participation in the program.

The goal of this single arm feasibility study of the Strength After Breast Cancer (SABC) evidence-based group exercise intervention for women after treatment for breast cancer is to determine if investigators can feasibly deliver the program out of the outpatient physical therapy clinic at Massachusetts General Hospital Waltham.

- Following a one-on-one physical therapy evaluation, the four-session SABC program provides a group-based but individualized exercise plan and encourages engagement in independent home-based exercises to improve physical function. The SABC program has previously been found to be safe and led to improvements in physical function among women after treatment for breast cancer. Therefore, the focus of this study is to explore clinical implementation barriers, facilitators, and necessary program adaptations to enhance sustainability and facilitate implementation at other clinical sites.

Study procedures include screening for eligibility, in-clinic visits, questionnaires, and a semi-structured interview.

Participation in this research study is expected to last up to 5 months. It is expected that up to 40 people will take part in this research study.

This is an unfunded study.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Diagnosed with Stage I-III breast cancer, having completed primary cancer treatment (e.g., surgery, chemotherapy, radiation therapy); hormonal therapies and adjuvant targeted therapies will be permitted

Exclusion Criteria:

* Any injury or medical condition that would prohibit being able to safely perform exercise as indicated by the Physical Activity Readiness Questionnaire (i.e., atrial fibrillation, chest pain or angina, uncontrolled high blood pressure or hypertension, loss of balance due to dizziness in the past 12 months, or loss of consciousness in the past 12 months).
* Non-English speaking
Preliminary Evaluation of Two Rapid Diagnostic Test Prototypes for Strongyloides Stercoralis Infection

Single center, no profit experimental study on sera available in the Tropica Biobank.


Eligibility Criteria:
Inclusion Criteria:

* Serum from immigrants from S. stercoralis endemic countries (i.e. individuals from Africa, Latin America, South-East Asia and western Pacific regions);
* Serum with a matched result of APC and/or PCR for S. stercoralis (i.e. the latter test/s done in the same day or ±30 days from the collection of the serum) and of serology assays (IFAT and/or ELISA) in use in our laboratory.

Exclusion Criteria:

* Unavailable/insufficient quantity of serum
* Serum from individuals who received treatment with ivermectin in the previous 6 months.
Symptoms and Endoscopic Results in Consideration of Pretreatment

Under daily routine conditions and without any intervention by the sponsor regarding the selection of subjects, diagnostic procedures, therapeutic decisions (medicinal and non- medicinal therapy, dose, duration, etc.), routine assessments, the participating physicians (i.e. gastroenterologists) are asked to document relevant data in patients with gastrointestinal disorders.


Eligibility Criteria:
Inclusion Criteria:

* patients with gastrointestinal disorders who need an endoscopy.

Exclusion Criteria:

* limitiations; possible risks; warnings; contraindications mentioned in the SPC.
Salivary Flow Rate and Oral Function

The purpose of this study was to investigate if salivary flow rate is important to maintain adequate oral functions.

Hyposalivation may damage oral functions. Therefore, the aim of this study was to evaluate whether patients under hyposalivation present damaged mastication and speech. Forty subjects composed 2 groups: Control (C) and hyposalivation (H). Masticatory performance (MP) was carried out using artificial material and a 10-sieve method. Mandibular movements during speech were obtained using a 3D jaw-tracking device. Neither mastication nor speech have been impaired by low salivary flow rate.

Eligibility Criteria:
Inclusion Criteria:

* Fully dentate
* Good general and oral health

Exclusion Criteria:

* Signs or symptoms of temporomandibular disorders
* Parafunctions
* Malocclusion
* History of communication deficits or prior speech-language treatment