cyrilzakka/clinical-trials huggingface dataset:
Tolerance and Acceptability Evaluation AYMES Cardiff

To evaluate tolerance and acceptability of 'CARDIFF' in patients requiring supplementary oral nutritional support compared with currently available alternatives.

To evaluate tolerance and acceptability of 'CARDIFF' in patients requiring supplementary oral nutritional support compared with currently available alternatives, measuring outcomes of GI effects, Compliance, product preference, convenience etc.

To obtain data to support an ACBS submissions for 'CARDIFF' (to allow for prescription in the community at NHS expense).

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients.
* ≥ 18 years of age.
* Patients of the intended target group (e.g. MUST score ≥ 1) with an anticipated period of nutritional support ≥ 30 days.
* Patient is able and willing to provide written informed consent.

Exclusion Criteria:

* Patients with medical or dietary contraindication to any feed ingredients.
* Patients requiring sole enteral tube feeding or parenteral nutrition.
* Patients with significant renal (requiring dialysis) or hepatic impairment (e.g. hepatitis.)
* Patients with dysphagia requiring levels 1, 2, 3 or 4 thickened fluids.
* Patients with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms.
* Patients for whom the investigator has concerns regarding the ability or willingness of the patient and or carer to comply with protocol requirements.
* Participation in any other studies involving investigational or marketed products concomitantly or within 2 weeks prior to entry into the study.
Longitudinal or Transverse Orientation of Ultrasound Probe in Minimally Invasive Venous Surgery.

Longitudinal ultrasound orientation during central venous cannulation has been suggested by a number of radomised studies to offer superior cannulation rates. This technique may offer a simple, safe and cost-neutral step to improve cannulation rates in the widely performed minimally invasive endovenous intervention.

Varicose veins are an extremely common disorder and negatively impact on patient quality of life. In recent years minimally invasive venous treatments for varicose veins (MIVT) have emerged as an effective alternative to open surgery. It is associated with a reduction in peri-operative morbidity, recovery time and increased quality of life scores when compared with open surgical stripping4. Furthermore, MIVT is now widely carried out under local anaesthesia.

Typically, MIVT requires cannulation, under ultrasound guidance, of either the great or small saphenous vein in the lower extremity to allow subsequent passage of a venous catheter. This cannulation technique is widely used for venous and arterial cannulation throughout the body. It entails utilising an ultrasound probe in either a longitudinal or transverse orientation (to the target vein) to guide an entry needle into a target vessel. The longitudinal orientation, while unstable, offers better visualisation of the vein when performed accurately. Conversely, the transverse approach is very stable with poorer visualisation of the target vessel. As such, no definitve guidance is available to guide treating physicians as to the optimal orientation with a wide variation among practitioners.

The cannulation process for MIVT is often further challenged by both the small calibre and tendency toward vasospasm of target veins. Failure of cannulation may result in greater rates of conversion to open surgery exposing the patient to the the higher rate of morbidity associated with open surgery. More importantly, repeated cannulation results in significant discomfort and hence a reduction in patient satisfaction.

Longitudinal ultrasound orientation during venous cannulation has been suggested by a number of radomised studies to offer superior cannulation rates of cannulation. This technique may offer a simple, safe and cost-neutral step to improve cannulation rates in the widely performed MIVT.

The authors propose a blinded randomized controlled study to investigate the effects of ultrasound orietation on cannulation rates in MIVT. To test this hypothesis we plan to randomise 100 patients undergoing MIVT to either venous cannulation with transverse or longitudinal orientation of the ultrasound probe.

Eligibility Criteria:
Inclusion Criteria:

* For minimally invasive venous surgery of the lower limb (Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification score 2 of greater)
* Intervention requiring venous cannulation of axial lower limb vein
* Full consent
* \>18 years
* No concomitant deep venous incompetence

Exclusion Criteria:

* General anaesthesia
Autonomic and Cardiovascular Recovery After the Acute Use of Resveratrol in Overweight and Obesity Individuals

The aim of this study is to understand the importance of resveratrol supplementation as a possible adjuvant in improving the metabolic profile and cardiovascular autonomic recovery of individuals with overweight and grade I obesity, reducing the incidence of diseases associated with obesity and the costs in primary, secondary and tertiary care.

Food is a strong ally in improving the metabolic state in overweight, obesity and prevention of associated diseases, working on weight loss and ingestion of anti-inflammatory, anti-oxidant and cardioprotective substances, among these substances, we highlight the polyphenols. Resveratrol or 3,5,4-trihydroxystilbene is a polyphenol studied since 1976, a phytoalexin synthesized in the skin of the grape, which is increased when exposed to stresses such as ultraviolet radiation, enhancing the antioxidant and cardioprotective characteristics.This study aims to evaluate the cardiovascular autonomic recovery and the metabolic profile with the acute effect of resveratrol extract after submaximal aerobic exercises in individuals with overweight and grade I obesity.Heart rate variation (HRV) is considered the most trivial method for analyzing the behavior of autonomic efferents (parasympathetic and sympathetic) on the heart. HRV recovery after exercise has been widely used as a method of analyzing ANS adaptation (vagal recovery) under various conditions.Healthy, physically active individuals with good health characteristics have a rapid recovery of HRV after exercise, indicating good adaptability and a lower risk for cardiovascular diseases. Meanwhile, changes HRV patterns provide a sensitive and early indicator of health impairments. The monitoring of these data is necessary, as they act as markers of emerging risk for the development of complications associated with CNCDs and risks of future injuries. In this context, the present project will make it possible to verify the effect of the acute use of resveratrol on the metabolic profile and on the autonomic and cardiovascular recovery of individuals with overweight and obesity grade I.

Eligibility Criteria:
Inclusion Criteria:

- Individuals with overweight and obesity grade I

Exclusion Criteria:

* Cardiorespiratory disorders
* Neurological disorders
* skeletal muscle injury
* Known impairments that prevent the subject from performing the procedures.
Influence of Drainage on EVD ICP-signal

This observational study investigates ICP signals obtained through an external ventricular drain in the brain connected with an external transducer. In particular, the study investigates how drainage influences the monitored signal: influence of flow rate, reservoir height and initial ICP before draining.


Eligibility Criteria:
Inclusion Criteria:

* TBI/SAH patients with need for ICP monitoring

Exclusion Criteria:

-
Observational Study Evaluating the Efficacy and Safety of Zanubrutinib in Participants With Waldenström Macroglobulinemia

This is a hybrid (retrospective and prospective) non-interventional registry study to further describe the clinical profile of zanubrutinib in Waldenström macroglobulinemia (WM) participants with and without specific mutations and from racial and ethnic minority groups. Data collected from this registry study will be used to better understand the clinical benefit and safety of zanubrutinib for the treatment of participants in these populations.


Eligibility Criteria:
Inclusion Criteria:

* Clinical and definitive histologic diagnosis of WM
* Measurable disease, as defined by a serum immunoglobulin M (IgM) level \> 0.5 g/dL at the time of zanubrutinib initiation
* Started treatment with zanubrutinib, has been treated with zanubrutinib, or is planned to be prescribed zanubrutinib for the treatment of WM
* Bone marrow specimens with central MYD88 test results of:

  1. Cohort 1: MYD88 L265P mutation; enrollment of TN participants will be stopped in each racial and ethnic participant group when the required numbers of participants in the group are met
  2. Cohort 2: non-L265P MYD88 mutation(s) and MYD88WT

Exclusion Criteria:

* Evidence of disease transformation before the first dose of zanubrutinib
* Evidence of other non-Hodgkin Lymphoma (NHL) subtypes
* Prior or concurrent active malignancy ≤ 2 years before the first dose of zanubrutinib, except for malignancies that, in the investigator's opinion, will not obscure the interpretation of safety or efficacy results
* Concurrent participation in another therapeutic clinical study while receiving zanubrutinib, although the participant may be eligible depending on the status of the interventional study after discussion with the Medical Monitor or designee on an individual basis
OSI-774 (Erlotinib, Tarceva) in Elderly Patients

The purpose of this research study is to determine if OSI-774 (Tarceva) is effective in the treatment of non-small cell lung cancer and to further study its side effects. The investigators would also like to estimate disease-related symptom improvement rates using a questionnaire.

In recent years, it has been shown that the degree of improvement achievable with chemotherapy has plateaued with the use of chemotherapy doublets. The presence of co-morbid conditions and poor performance status may preclude the use of chemotherapy in many elderly patients, which even in the medically fit, has modest benefits. The advent of targeted cancer therapy with the discovery of tyrosine kinases as mediators of tumor growth, with its limited toxicity profile, offers a promising approach to the treatment of NSCLC, in particular to the elderly subset of patients. The encouraging results from the other trials provide a strong rationale to evaluate an oral EGFR-tyrosine kinase inhibitor OSI-774 in patients with advanced and inoperable NSCLC over the age of 70. In vitro and clinical data suggest a dose- dependent response with Tarceva (Genentech, data on file).

Eligibility Criteria:
Inclusion Criteria:

* Patients must have confirmed non-small cell lung cancer. Age \> 65 years Patients must have adequate organ and marrow function

Exclusion Criteria:

* Patients who have had prior chemotherapy will be excluded. Patients may not be receiving any other investigational agents.
Usefulness of Capillary Refill Time and Skin Mottling Score to Predict Intensive Care Unit Admission

In the emergency department (ED), the severity assessment of shock is a fundamental step prior to the admission in intensive care unit (ICU). As biomarkers are time consuming to evaluate severity of the micro and macro-circulation alteration, capillary refill time and skin mottling score are 2 simples, available clinical criteria validated to predict mortality in the ICU.

The aim of this study is to provide clinical evidence that capillary refill time and skin mottling score assessed in the ED also predict ICU admission of patients with septic or haemorrhagic shock.

This trial is an observational, non-randomized controlled study. A total of 1500 patients admitted to the ED for a septic or hemorrhagic shock will be followed.

The primary outcome is the admission to the ICU.

The study will not impact the treatments provided to each patient. Capillary refill time and skin mottling score will not be taken into account to decide patient's treatments and/or ICU admission. Patients will be followed during their hospital stay in order to precise their destination after ED (home, ICU, ward) and 28- and 90-days mortality after hospital admission.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years
2. Skin mottling score\> 2 and/or capillary refill time \> 3secondes associated with at least one of the followings measured at the ED admission by the nurse in charge of the patient:

   1. Systolic blood pressure \< 90mmHg or blood pressure decrease of 30% at least for patients with high blood pressure history
   2. Heart rate \> 120 beats per minute
   3. Respiratory rate \> 22 movements per minute
   4. Glasgow coma scale \< 13.

Exclusion Criteria:

1. Age \< 18 years
2. Pregnancy
3. Serious co morbid conditions with a not to be reanimated status known at the ED admission
4. Patients with guardianship or curator
Characterization of DupEx2 Duchenne Muscular Dystrophy

To characterize the clinical phenotype and possible predictive/prognostic factors of patients with Duchenne muscular dystrophy (DMD) due to duplication of exon 2 (Dup2). Specifically, we aim 1) to describe the progression of motor, respiratory and cardiac function; 2) to enquire if the phenotypic spectrum of Dup2 is milder than classic DMD, 3) to perform whole genome sequencing (WGS) to characterize DNA breakpoints to correlate with the phenotype; 4) to collect material for future proteomic/transcriptomic studies.

Background/Rationale DMD is caused by mutations in the DMD gene and in 11% of cases is due to duplications. The most promising therapeutic approaches include mutation-specific therapies. Notably, there is increasing evidence that specific groups of mutations may underlie different disease trajectories compared to the "average" DMD population. It is thus mandatory to have more information on genotype-phenotype correlations and patterns of progression related to different genotypes.

Dup2 is the most common DMD duplication and the only one for which a AAV-mediated exon skipping study is ongoing. Despite most case series and databases ascribe Dup2 to severe phenotype, our preliminary findings sustain that these patients have collectively a milder progression of the disease and in 1/3 of cases a significantly milder phenotype. Moreover, our attempts to reveal mechanism involved in attenuating the phenotype would confute the hypothesis of alternative spicing transcripts as previously described for DMD with deletion of exon 2.

Research design and methods Clinical information regarding a cohort of 26 Italian Dup2 patients will be collected. Differences in time to loss of ambulation compared to a DMD control group will be achieved. Finally, we will retrieve DNA for correlative WGS studies.

Anticipated output We expect that Dup2 patients present a milder DMD phenotype , which might be predicted by genomic studies.

The primary clinical endpoint is time to loss of ambulation (LOA).

Secondary endpoints include:

1. The change over time of the following functional measurements:

   1.1 Motor function: The 6 Minute Walk test (6MWT) and North Star Ambulatory Assessment (NSAA) including sub-items such as Time to Rise from the floor.

   1.2 Respiratory function: Forced Vital Capacity (FVC) Liters (L) and % of predicted; time to FVC% \< 50%. Time to Nocturnal Ventilation initiation.

   1,3 Cardiac function: Left ventricular ejection fraction (EF) as measured by echocardiogram.
2. To characterize DNA breakpoints in mild vs severe phenotypes

Eligibility Criteria:
Inclusion Criteria:

* pediatric and adult DMD patients harboring a genetically confirmed duplication of the exon 2 in the dystrophin gene

Exclusion Criteria:

* patients lacking genetic confirmation of Dup2 mutation
Comparison of On-Site Versus Off-Site Evaluation of Cholangioscopy-Guided Biopsies of the Bile Duct

This study will test two different methods for processing biopsy specimens taken from the bile duct. Patient;s who are asked to participate int his study have a stricture in the bile duct that needs a single operator cholangioscopy-guided biopsies during endoscopic retrograde cholangiopancreatography (ERCP) so that a diagnosis can be made. Standard of care includes performing single operator cholangioscopy-guided biopsies in the bile duct and sending the tissue to the lab for testing to make a diagnosis. Using this method the investigators can establish a diagnosis only about 50% of the time. The investigators believe that if a cytopathologist is available in the endoscopy suite during the procedure to evaluate the biopsy specimens onsite, the investigators can improve the diagnostic accuracy. The purpose of this study is to compare two methods for processing biopsies obtained from the bile duct (Onsite vs. Offsite).

The diagnostic accuracy rate of single operator cholangioscopy-guided biopsy is only 50%. This translates to the need for performing repeat procedures to establish a diagnosis and therefore delays patient treatment. The biopsy specimen obtained at cholangioscopy are usually processed offsite in the pathology lab. We believe that if a pathologist can assess the tissue sample during the procedure itself (onsite) and provide feedback, the diagnostic accuracy rate will improve. This translates to better (faster) diagnosis and early treatment. Therefore, we will be comparing onsite versus offsite evaluation of bile duct biopsy specimens to determine which method yields a better diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Suspected biliary stricture

Exclusion Criteria:

* Age \< 18 years
* Pregnancy
* Altered surgical anatomy
* Irreversible elevation in INR \> 1.5 or low platelet count \< 50,000
Combating Maternal Mortality in Uganda: An Assessment of the Role of Misoprostol in Prevention of Post-Partum Hemorrhage

Null hypothesis: 10 IU Oxytocin is better than sublingual misoprostol 600µg in management of third stage of labor Alternative hypothesis: Sublingual misoprostol 600µg is non- inferior to 10 IU oxytocin and will not be more than 6% worse \[than 10 IU oxytocin\] in management of third stage of labor

Background: In Sub- Saharan Africa, one in 35 women die in child birth, 1000 times higher than the western world and Post-Partum Hemorrhage (PPH) accounts for the biggest percentage of maternal morbidity and mortality (WHO, 2005; WHO, 2010). Maternal Mortality in Uganda is one of the highest in the world at 435 for every 100,000 and 25% of these are due to PPH happening within 24 hours after delivery. Oxytocin, the standard of care in PPH management has registered challenges like requirement of sterile injections, requirement of trained personnel, special supply chain/storage conditions like refrigeration and protection from light affecting maximum treatment outcomes especially in poorly resourced developing countries where these are not realized. It has been argued that any effort or developments based on physiological processes towards the reduction of this horrific PPH rate would greatly have a significant impact on the lives of families and women worldwide. Several scholars have thus stressed a vital need to develop simple, practical and inexpensive techniques relevant to prevent and treat PPH in developing countries.

Eligibility Criteria:
Inclusion Criteria:Term mothers \[38-41 WOA\] above 18 years of age admitted at Mbarara Hospital, Uganda in active labor; anticipating vaginal delivery -

Exclusion Criteria:

Complicated labor:

1. confirmed intra-uterine fetal death
2. self-reported maternal heart disease
3. current diagnosis of severe malaria or acute bacterial infection,
4. multiple pregnancy,
5. induced or augmented labor,
6. elective Caesarean section,
7. ante-partum hemorrhage,
8. reported hypersensitivity to prostaglandins
9. altered cognitive status (ACS) as assessed by the MRAs. -
Evaluation of the Safety, Tolerability and Pharmacokinetics of Intravenous FL058 Administered in Healthy Subjects(SAD)

To evaluate the safety,tolerability and pharmacokinetics of single intravenous doses of FL058 in healthy Chinese subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults aged between 18 and 45 years (inclusive).
2. Body mass index (BMI) ranges from 19 to 26 kg/m2 (inclusive), and the body weight is ≥50kg.
3. Good general health as determined by the Investigator based on medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory tests.
4. Provide voluntary written informed consent prior to any study procedures and are willing and able to comply with the prescribed treatment protocol and evaluations.

Exclusion Criteria:

1. Concurrent or history of clinically significant cardiovascular, hepatic, renal, endocrine, gastrointestinal, respiratory, psychiatric, neurologic and/or hematological disorders.
2. Positive screen result for HBsAg, HCV-Ab, or HIV-Ab at screening.
3. History of clinically significant food or drug allergy.
4. A QT interval corrected using Fridericia's formula \>450 msec.
5. eGFR\<90mL/min/1.73m2.
"Cognitive, Motor and Sleep Evaluation in Patients With Ischemic Stroke of Basal Ganglia After Thrombectomy"

The goal of this interventional study is to learn about the clinical outcomes of acute ischemic stroke treated with mechanical thrombectomy resulting in a selective ischemia of the basal ganglia. The main question it aims to answer is:

• defining the prevalence and clinical features of possible cognitive, motor and sleep disfuncions occuring after acute ischemic stroke treated with thrombectomy

Participants will be tested for cognitive, movement and sleep disorders in the acute phase and successively in the long term follow-up.


Eligibility Criteria:
Inclusion Criteria:

* participant's age ≥ 18 years
* acute ischemic stroke due to occlusion of proximal middle cerebral artery successfully treated with mechanical thrombectomy (mTICI ≥ 2B)
* signature of specific written informed consent

Exclusion Criteria:

* unstable clinical conditions
* personal history of cognitive decline before the acute ischemic stroke